Patent Application
20240325036
The disclosure generally relates to systems and methods for removing occlusions and unwanted matter from vessels, ducts and other cavities or lumens of a subject. More particularly, the disclosure relates to catheter-based systems, apparatus and methods for removing occlusions and unwanted matter from vascular vessels.
Current medical systems and devices that are used for the removal of occlusions, such as thrombi from vessels (such as those in the brain), have limitations that reduce their effectiveness, reliability, and ease of use.
Current systems and devices are also not appropriate for use in large vascular structures such as aorta, vena cava and many peripheral vascular applications, and often do not work well with calcified, organized embolic material due to the inability of wire structures often used by such devices to compress into the embolic material prior to an attempted extraction.
Current systems and devices also often have a wire structure that must incorporate into a thrombus to remove a clot and, thus, provide poor distal protection from secondary emboli during thrombus extraction due to an open-ended structure of a stent retriever or partial grasping of the thrombus. This may result in an intended thrombectomy procedure causing distal clot embolization and occlusion of previously patent arterial branches and collaterals.
Further, current systems and devices are typically less effective when used with associated arterial stenoses due to device collapse and tendency for a stenosis to strip and debride a thrombus from a device as it is retracted through the stenotic vessel segment.
Current systems and devices often require operators to choose a predetermined device length at time of device insertion, but the chosen device length might not match the size of the target thrombus once the operator is in the vessel and is provided with a closer view of the target thrombus.
Current catheter-based systems and methods for the removal of foreign bodies from an artery, duct, ureter or other interior physical space, also often require multiple co-axial (or concentric) sleeves or delivery catheters, some of which are intended for placement on the proximal side of an occlusion, some for direction through the occlusion for placement on the distal side of the occlusion, and still others for holding inflatable balloons, thrombus removal devices and the like.
The presence of multiple catheters increases manufacturing complexity and cost, in addition to increasing complexity of usage during an intervention, with greater moving parts and the required ordering of operation aligned with the function of the multiple catheters.
Current catheter-based systems and methods are also manufactured and deployed in the clinical setting with a specific catheter, meaning that if during an intervention a clinician wants to deploy (or “load”), for example, a retrieval device having a different size than that first deployed in a vessel, the entire catheter-based tool must be withdrawn and a new catheter-based device with the preferred diameter loaded inserted.
Additional limitations of the current catheter-based systems include, but are not limited to, a reliance on fixed-diameter instrumentation and/or inflatable bodies (e.g., balloons) for encapsulation of a foreign body or occlusion. As an example, catheters using an inflatable balloon for a distal body and/or proximal body may require that an interventionist pre-select a balloon model and size prior to entering a vessel or cavity because inflatable balloons have a manufactured minimum and maximum inflation diameter. Thus, if the incorrect balloon size is selected, or the clinical setting requires flexibility in the expansion or contraction diameter of the distal or proximal bodies, the intervention may be interrupted to allow for size adaptation of equipment. Incorrect sizing may also increase the likelihood for negative clinical sequelae, such as embolization and release of occlusive matter if, for example, distal protection is lost.
Additionally, current systems and methods fail to catch or prevent small portions of a dislodged occlusion from passing through a patient's vessels and possibly causing a thrombosis. Existing devices and treatment methods permit portions of the occlusion, albeit smaller sized portions, to pass through the vessel and are not effective at capturing and extracting those portions.
Therefore, there is a need for systems and methods for removal of thrombi, or other matter, in which an object targeted for removal may be dynamically surrounded by a retrieval device, rather than incorporated into the target object, wherein the retrieval device can surround the target and may be physically adjusted to match the size of the target object while within the vessel or other cavity.
There is also a need for systems and methods for removal of thrombi, or other matter, removal in which a larger percentage of such matter is captured while not creating an unduly difficult to use or navigate device.
There is also a need for systems and methods for removal of calcified thrombi, or other matter.
The present invention is directed to systems, apparatus and methods for removal of occlusions and unwanted matter from vessels, ducts and other cavities or lumens of a subject.
In some embodiments of the invention, there is thus provided a system for removal of occlusions and unwanted matter from a cardiovascular vessel, i.e., a recanalization system.
In one embodiment of the invention, the recanalization system comprises a handle and an elongate member, the elongate member comprising an occlusion dislodging member adapted to dislodge an occlusion in a cardiovascular vessel, the occlusion dislodging member coupled to the elongate member and adapted to axially move, radially expand and contract, and rotate, the handle adapted to selectively induce the axial movement, radial expansion and contraction, and rotation of the occlusion dislodging member.
In another embodiment of the invention, the recanalization system comprises a handle and an elongate member, the elongate member comprising a distal element and a proximal element, the distal element and the proximal element coupled to the elongate member, the distal element adapted to first radially expand from a first pre-expansion configuration to a first expanded configuration, the proximal element adapted to rotate and second radially expand from a second pre-expansion configuration to a second expanded configuration, the proximal element further adapted to move axially relative to the distal element, the handle adapted to selectively induce the first radial expansion of the distal element, the second radial expansion of the proximal element, the axial movement of the proximal element and the rotation of the proximal element.
In another embodiment of the invention, the recanalization system comprises a handle and an elongate member, the elongate member comprising a distal element and a proximal element, the distal element coupled to the elongate member and adapted to first radially expand from a first pre-expansion configuration to a first expanded configuration, and first contract from the first expanded position to a first contracted configuration, the proximal element adapted to second radially expand from a second pre-expansion configuration to a second expanded configuration, and second contract from the second expanded position to a second contracted configuration, the proximal element further adapted to rotate and move axially with respect to the distal element, the handle comprising a plurality of physically manipulable interfaces adapted to induce the first radial expansion and the first contraction of the distal element, the second radial expansion and the second contraction of the proximal element, the rotation of the proximal element and the axial movement of the proximal element.
In some embodiments, the plurality of physically manipulable interfaces is further adapted to said induce said rotation of said proximal element without said inducing said axial movement of said proximal element.
In some embodiments, the system further comprises a sensor system adapted to monitor the force exerted on a wall of a cardiovascular vessel by the proximal and distal elements when the proximal and distal elements are disposed in the vessel and radially expand.
In some embodiments, the system further comprises an aspiration system.
Further features and advantages will become apparent from the following and more particular description of the preferred embodiments of the invention, as depicted in the accompanying drawings, and in which like referenced characters generally refer to the same parts or elements throughout the views, and in which:
Before describing the present invention in detail, it is to be understood that this invention is not limited to particularly exemplified apparatus, systems, structures or methods as such may, of course, vary. Thus, although a number of systems, apparatus, structures and methods similar or equivalent to those described herein can be used in the practice of the present invention, the preferred systems, apparatus, structures and methods are described herein.
It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments of the invention only and is not intended to be limiting.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one having ordinary skill in the art to which the invention pertains.
For the purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been exhaustively described in detail so as not to unnecessarily obscure the present invention.
Further, all publications, patents and patent applications cited herein are hereby incorporated by reference in their entirety.
As used in this specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to “a pharmacological agent” includes two or more such agents and the like.
Further, ranges can be expressed herein as from “about” or “approximately” one particular value, and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about” or “approximately”, it will be understood that the particular value forms another embodiment. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.
It is also understood that there are a number of values disclosed herein, and that each value is also herein disclosed as “about” or “approximately” that particular value in addition to the value itself. For example, if the value “10” is disclosed, then “approximately 10” is also disclosed.
It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “10” is disclosed then “less than or equal to 10” as well as “greater than or equal to 10” is also disclosed.
In the description and claims of the application, each of the words “comprise”, “include”, “have”, “contain”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated. Thus, they are intended to be equivalent in meaning and be open-ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items or meant to be limited to only the listed item or items.
In various embodiments, the retrieval devices of the present specification may comprise a catheter-delivered device or system used to remove a foreign body, such as a thrombus or clot, from an artery, vein, nerve, duct, or other interior physical space.
The retrieval devices may be interchangeably referred to herein as a “retrieval system” and/or a “removal device” and/or a “recanalization system”, the “removal” or “retrieval” of the foregoing may be modified by a variety of terms such as “thrombus,” “occlusion,” “foreign body,” etc.
According to the invention, retrieval devices of the present specification can be used in vascular systems and, hence, vessels and in non-vascular structures, such as ureters, ducts, airways, and any other accessible space that contains a material (biologic or foreign) that necessitates removal or retrieval.
In various embodiments, the retrieval devices of the present specification are configured to be used in all venous structures, including dural venous sinuses, coronary arteries, cardiac chambers, all arteries, all ducts, ureters, urethra and fistulas.
Although systems, apparatus and methods similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present disclosure, the preferred, systems, apparatus and methods are now described.
The terms “element”, “body” and “member” are used interchangeably herein in connection with the medical systems and apparatus of the invention, and mean and include permeable, partially impermeable and impermeable structures adapted to communicate with delivery wires and elongated delivery members of the medical systems and apparatus.
The terms “clot”, “thrombus”, “occlusion”, “vessel occlusion”, “blockage” and “foreign body” are also used interchangeably herein and mean and include unwanted or undesired material in a patient's veins or arteries that is partially or completely obstructing the flow of blood, or unwanted or undesired material disposed in any vessel in a subject's body that is partially or completely obstructing the flow of any fluid, such as urine, therethrough.
The terms “clot”, “thrombus”, “occlusion”, “vessel occlusion”, “blockage” and “foreign body” thus mean and include, without limitation, acute thrombi, subacute thrombi and chronic thrombi of arterial and venous structures.
The term “pharmacological agent,” as used herein, means and includes an element, agent, compound, composition of matter or mixture thereof, including its formulation, which produces a localized or systemic effect or effects in animals, including warm blooded mammals, humans and primates; avians; domestic household or farm animals, such as cats, dogs, sheep, goats, cattle, horses and pigs; laboratory animals, such as mice, rats and guinea pigs; fish; reptiles; zoo and wild animals; and the like.
The term “pharmacological agent” thus means and includes, without limitation, antithrombotic agents (including anticoagulants and antiplatelet agents), anti-inflammatory agents, antibiotics, anti-neoplastic agents, anti-metabolite/anti-proliferatives, HMG-CoA reductase inhibitors, anti-arrhythmic agents, proteins, hormones, growth factors, matrix metalloproteinases (MMPs), enzymes and enzyme inhibitors, DNA, RNA, modified DNA and RNA, NSAIDs, inhibitors of DNA, RNA or protein synthesis, polypeptides, oligonucleotides, polynucleotides, nucleoproteins, compounds modulating cell migration, compounds that modulate cell proliferation and growth of tissue, and vasodilating agents.
The term “pharmacological agent” thus means and includes, without limitation, the following classes or categories of anticoagulants: coumarins/indandiones, factor Xa inhibitors, thrombin inhibitors, and heparins.
The term “pharmacological agent” thus means and includes, without limitation, the following anticoagulants (or anti-thrombotic agents): warfarin, apixaban, edoxaban, rivaroxaban, arixtra, betrixaban, ardeparin, argatroban, dabigatran, bivalirudin, desirudin, heparin, enoxaparin, dalteparin, fragmin, fondaparinux, tinzaparin, and combinations thereof.
The term “pharmacological agent” also means and includes, without limitation, the following classes or categories of antiplatelets: irreversible cyclooxygenase inhibitors, adenosine diphosphate (ADP) receptor inhibitors, phosphodiesterase inhibitors, protease-activated receptor-1 antagonists, and combinations thereof.
The term “pharmacological agent” thus means and includes, without limitation, the following antiplatelets: acetylsalicylic acid (also referred to as “aspirin”), cangrelor, clopidogrel, prasugrel, ticagrelor, ticlopidine, cilostazol, dipyridamole, vorapaxar, and combinations thereof.
The term “pharmacological agent” also means and includes, without limitation, the following classes or categories of anti-inflammatories: disease-modifying antirheumatic drugs (DMARDs), alkaloids, biopharmaceuticals or biologics (e.g., monoclonal antibody-based agents), 5-lipoxygenase (5-LO) inhibitors, phospholipase A2 (PLA2) inhibitors, non-steroidal anti-inflammatory agents, and steroidal anti-inflammatory agents.
The term “pharmacological agent” thus means and includes, without limitation, the following anti-inflammatories: hydroxychloroquine (HCQ), methotrexate (MTX), colchicine, canakinumab (Ilaris®), adalimumab (Humira®), certolizumab pegol (Cimzia®), etanercept (Enbrel®), golimumab (Simponi, Simponi Aria®), infliximab (Remicade®), zileuton, varespladib, varespladib methyl, darapladib, ibuprofen, naproxen sodium, celecoxib, diclofenac, fenoprofen, indomethacin, ketorolac, prednisone, methylprednisolone suleptanate, prednisolone, triamcinolone, methylprednisolone, dexamethasone, desoximetasone, dexamethasone dipropionate, fludrocortisone, cloticasone propionate, diftalone, fluorometholone acetate, fluquazone, meseclazone, mesterolone, methandrostenolone, methenolone, methenolone acetate, halopredone acetate, alclometasone dipropionate, apazone, balsalazide disodium, cintazone cormethasone acetate, cortodoxone, diflorasone diacetate, diflumidone sodium, endrysone, fenpipalone, flazalone, fluretofen, fluticasone propionate, isoflupredone acetate, nabumetone, nandrolone, nimazone, oxyphenbutazone, oxymetholone, phenbutazone, pirfenidone, prifelone, proquazone, rimexolone, seclazone, tebufelone, testosterone, and combinations thereof.
The term “pharmacological agent” also means and includes, without limitation, the following classes or categories of antibiotics: aminoglycosides, macrolides (including azolides), beta-lactamase inhibitors (including penicillins, and carbapenems), glycopeptides, tetracyclines, cephalosporins, rifamycins, quinolones, sulfonamides, lincomycins/lincosamides, nitroimidazoles and fluoroquinolones.
The term “pharmacological agent” thus further means and includes, without limitation, the following antibiotics: gentamicin, tobramycin, plazomicin (semi-synthetic aminoglycoside), erythromycin, azithromycin, clarithromycin, roxithromycin, fidaxomicin, vancomycin, dalbavancin, oritavancin, telavancin, amoxicillin (including co-amoxiclav), ampicillin, oxacillin, flucloxacillin, phenoxymethylpenicillin, temocillin, ticarcillin, dicloxacillin, meropenem, impenem, ertapenem, doripenem, tazobactam, relebactam, doxycycline, minocycline, sarecycline, omadacycline, eravacycline, lymecycline, eravacycline, cephalexin, cefazolin, cefiderocol, ceftazidime, avibactam, cefrolozane, ceftaroline, cefepime, cefdinir, cefixime, cefotaxime, cefpodoxime, ceftriaxone, cefadroxil, cefaclor, cefotetan, cefoxitin, cefprozil, cefuroxime, rifampin, rifabutin, rifapentine, rifalazil, rifaximin, enoxacin, ciprofloxacin, levofloxacin, norfloxacin, ofloxacin, lomefloxacin, sparfloxacin, grepafloxacin, clinafloxacin, gatifloxacin, moxifloxacin, sulfamethoxazole, sulfisoxazole, clindamycin, lincomycin, metronidazole, tinidazole, nimorazole, and combinations thereof.
The term “pharmacological agent” also means and includes, without limitation, the following classes or categories of anti-neoplastics: mTOR inhibitors, taxanes, platinum compounds, antifolates, nucleoside analogs, topoisomerases, anthracyclines, podophyllotoxins, vinca alkaloids, alkylating agents, biopharmaceuticals or biologics (e.g., monoclonal antibody-based agents), tyrosine kinase inhibitors, retinoids, histone deacetylase inhibitors, and immunomodulatory agents (IMiDs).
The term “pharmacological agent” thus further means and includes, without limitation, the following anti-neoplastics: everolimus, sirolimus, temsirolimus, zotarolimus, biolimus, cabazitaxel, docetaxel, paclitaxel, carboplatin, cisplatin, nedaplatin, oxaliplatin, methotrexate (MTX), pemetrexed, pralatrexate, raltitrexed, trimetrexate, azacitidine, capecitabine, carmofur, cladribine, clofarabine, cytarabine, decitabine, floxuridine, fludarabine, flurouracil, gemcitabine, mercaptopurine, nelarabine, pentostatin, tegafur, tioguanine, irinotecan, topotecan, daunorubicin, doxorubicin, epirubicin, idarubicin, mitoxantrone, valubicin, etoposide, teniposide, vinblastine, vincristine, vindesine, vinflunine, vinorelbine, altretamine, bendamustine, busulfan, carmustine, chlorambucil, chlormethine, cyclophosphamide, dacarbazine, fotemustine, ifosfamide, lomustine, lurbinectedine, mechlorethamine, melphalan, streptotocin, temozolomide, thiotepa, trabectedin, alemtuzumab, bevacizumab, cetuximab, denosumab, gemtuzumab ozogamicin, ibritumomab tiuxetan, ipilimumab, nivolumab, ofatumab, panitumumab, pembrolizumab, pertuzumab, rituximab, tositumomab, trastuzumab, afatinib, aflibercept, axitinib, bosutinib, crizotinib, dasatinib, erlotinib, gefitinib, imatinib, lapatinib, nilotinib, pazopanib, ponatinib, regorafenib, ruxolitinib, sorafenib, sunitinib, vandetanib, alitetinon, bexarotene, isotretinoin, tamibarotene, panobinostat, romidepsin, valproate, vorinostat, lenalidomide, pomalidomide, thalidomide, and combinations thereof.
The term “pharmacological agent” also means and includes, without limitation, the following anti-metabolites/anti-proliferatives: mycophenolate mofetil, mycophenolate acid, mycophenolate sodium, azathioprine, and combinations thereof.
The term “pharmacological agent” also means and includes, without limitation, the following HMG-CoA reductase inhibitors (also referred to as “statins”): rosuvastatin, atorvastatin, cerivastatin, pitavastatin, simvastatin, pravastatin, fluvastatin, lovastatin, and combinations thereof.
The term “pharmacological agent” also means and includes, without limitation, the following classes or categories of anti-arrhythmics: group I antiarrhythmics, group II antiarrhythmics, group III antiarrhythmics, group IV antiarrhythmics, and group V antiarrhythmics.
The term “pharmacological agent” thus means and includes, without limitation, the following anti-arrhythmics: phenytoin, flecainide, propafenone, disopyramide, mexiletine, moricizine, lidocaine, tocainide, quinidine, procainamide, propranolol, acebutolol, esmolol, dofetilide, dronedarone, amiodarone, sotalol, ibutilide, diltiazem, verapamil, digoxin, adenosine, and combinations thereof.
The term “pharmacological agent” thus further means and includes, without limitation, a tissue plasminogen activator (tPA), urokinase, alteplase, ethylene diamine tetraacetic acid (EDTA), and diethylene triamine pentaacetic acid (DTPA).
The term “pharmacological agent” also means and includes, without limitation, an element, agent, compound, composition of matter or mixture thereof, including its formulation, which is adapted to enhance the flow rate of blood through a cardiovascular vessel.
The term “pharmacological agent” thus further means and includes, without limitation, blood soluble, non-toxic macromolecules, i.e., drag-reducing polymers (DRPs).
The term “pharmacological agent composition,” as used herein, means and includes a composition or mixture comprising a “pharmacological agent.”
The terms “extracellular matrix” and “ECM”, are used interchangeably herein, and mean the collagen-rich three-dimensional network, which provides structural and biochemical support to surrounding cells.
According to the invention, ECM can be derived from a variety of mammalian tissue sources and tissue derived therefrom, including, without limitation, small intestine submucosa (SIS), urinary bladder submucosa (UBS), stomach submucosa (SS), heart or cardiac tissue, central nervous system tissue, amniotic membrane tissue, placental tissue, epithelium of mesodermal origin, i.e., mesothelial tissue, dermal tissue, subcutaneous tissue, gastrointestinal tissue, placental tissue, omentum tissue, kidney tissue, pancreas tissue, lung tissue, and combinations thereof. The ECM can also comprise collagen from mammalian and plant sources.
The terms “acellular ECM” and “decellularized ECM”, as used interchangeably herein, mean ECM that is substantially devoid of cells, e.g., at least 99% devoid of cells.
The term “biologically active agent”, as used herein, means and includes an agent, compound, composition of matter or mixture thereof that induces or modulates a physiological or biological process, or cellular activity, e.g., induces proliferation, and/or growth and/or regeneration of tissue.
The term “biologically active agent” thus means and includes ECM, and any material processed therefrom, e.g., acellular or decellularized ECM.
The term “biologically active agent” also means and includes a growth factor, including, without limitation, transforming growth factor alpha (TGF-α), transforming growth factor beta (TGF-β), basic fibroblast growth factor (bFGF) (also referred to as fibroblast growth factor-2 (FGF-2)), vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF).
The term “biologically active agent” also means and includes agents commonly referred to as a “protein”, “peptide” and “polypeptide”, including, without limitation, collagen (types I-V) and proteoglycans.
The term “biologically active agent” also means and includes glycosaminoglycans (GAGs), including, without limitation, heparin, hyaluronic acid, and GAG derivatives, e.g., heparan sulfate.
The term “biologically active agent” also means and includes, without limitation, the following cells and compositions comprising same: endothelial cells, vascular smooth muscle cells, valvular interstitial cells (VICs), cardiac progenitor cells (CPCs), mesenchymal stem cells (MSCs), induced pluripotent (iPS) stem cells, and embryonic stem cells (ESCs).
The terms “biologically active agent” also means and includes an “extracellular vesicle (EV)”, “exosome”, “microsome” or “micro-vesicle”, which are used interchangeably herein, and mean and include a biological structure formed from a hydrocarbon monolayer or bilayer configured to contain or encase a composition of matter.
The terms “extracellular vesicle (EV)”, “exosome”, “microsome” and “micro-vesicle” thus include, without limitation, a biological structure formed from a lipid layer configured to contain or encase biologically active agents, pharmacological agents and/or combinations thereof.
The terms “extracellular vesicle (EV)”, “exosome”, “microsome” and “micro-vesicle” also include, without limitation, EVs derived from the aforementioned cells and compositions comprising same, e.g., MSC-derived EVs.
The terms “remodel” and “remodeling”, as used herein in connection with biological structures and tissue, mean and include a series of events, including changes in gene expression, molecular, cellular and interstitial changes, which result in restructuring and, in many instances, healing of damaged biological structures and tissue, such as a luminal wall of an arterial or venous vessel.
According to the invention, remodeling of damaged tissue of luminal walls of arterial or venous vessels and, hence, arterial or venous vessels can be induced or supported by at least one of the aforementioned pharmacological agents and/or biologically active agents when delivered into the vessels, i.e., at an occlusion formation site in the vessels.
The terms “regenerate” and “regeneration”, as used herein in connection with biological tissue, mean and include a series of events, including changes in gene expression, molecular, cellular and interstitial changes, which induce or generate nascent or “new” tissue in vivo by inducing proliferation of endogenous cells and reconstruction of extracellular matrix structures.
According to the invention, regeneration of damaged tissue of luminal walls of arterial or venous vessels can also be induced or supported by at least one of the aforementioned pharmacological agents and/or biologically active agents when delivered into the vessels.
The term “angiogenesis”, as used herein in connection with biological structures and tissue, means a physiologic process involving the growth of new blood vessels from pre-existing blood vessels in biological structures and tissue.
The term “neovascularization”, as used herein in connection with biological structures and tissue, means and includes the formation of functional vascular networks that can be perfused by blood or blood components. Neovascularization thus includes angiogenesis, budding angiogenesis, intussusceptive angiogenesis, sprouting angiogenesis, therapeutic angiogenesis, arteriogenesis, and vasculogenesis.
The term “biodegradable”, as used herein, means the ability of a material; particularly, a polymer, to breakdown and be absorbed within the physiological environment of a vessel and/or a structure associated therewith, including venous and arterial vessel structures, by one or more physical, chemical, or cellular processes.
The term “biodegradable polymer”, as used herein thus means and includes, without limitation, polylactide polymers (PLA), copolymers of lactic and glycolic acids, including poly(glycerol sebacate) (PGS) and its derivatives, including poly(glycerol-co-sebacate acrylate) (PGSA), poly(lactic-co-glycolic) acid (PLGA) and poly(ε-caprolactone-co-L-lactic) acid (PCL-LA); glycine/PLA co-polymers, polyethylene oxide (PEO)/PLA block copolymers, acetylated polyvinyl alcohol (PVA)/polycaprolactone copolymers, poly(polyol sebacate) (PPS), poly(xylitol sebacate) (PXS), poly(xylitol glutamate sebacate) (PXGS), hydroxybutyrate-hydroxyvalerate copolymers, polyesters such as, but not limited to, aspartic acid and different aliphatic diols; poly(alkylene tartrates) and their copolymers with polyurethanes, polyglutamates with various ester contents and with chemically or enzymatically degradable bonds, other biodegradable nonpeptidic polyamides, amino acid polymers, polyanhydride drug carriers such as, but not limited to, poly(sebacic acid) (PSA); aliphatic-aromatic homopolymers, and poly(anhydride-co-imides), poly(phosphoesters) by matrix or pendant delivery systems, poly(phosphazenes), poly(iminocarbonate), crosslinked poly(ortho ester), hydroxylated polyester-urethanes, or the like.
The terms “prevent” and “preventing” are used interchangeably herein, and mean and include reducing the frequency or severity of a disease, condition, dysfunction or disorder. The term does not require an absolute preclusion of the disease, condition, dysfunction, or disorder. Rather, this term includes decreasing the chance for disease occurrence.
The terms “treat” and “treatment” are used interchangeably herein, and mean and include medical management of a patient with the intent to cure, ameliorate, stabilize, or prevent a disease, pathological condition, dysfunction or disorder. The terms include “active treatment”, i.e., treatment directed specifically toward the improvement of a disease, pathological condition, dysfunction, or disorder, and “causal treatment”, i.e., treatment directed toward removal of the cause of the associated disease, pathological condition, dysfunction, or disorder.
The terms “treat” and “treatment” further include “palliative treatment”, i.e., treatment designed for the relief of symptoms rather than the curing of the disease, pathological condition, dysfunction, or disorder, “preventative treatment”, i.e., treatment directed to minimizing or partially or completely inhibiting the development of the associated disease, pathological condition, dysfunction, or disorder, and “supportive treatment”, i.e., treatment employed to supplement another specific therapy directed toward the improvement of the associated disease, pathological condition, dysfunction, or disorder.
The term “therapeutically effective”, as used herein, means that the amount of the “pharmacological agent” and/or “biologically active agent” and/or “pharmacological agent composition” and/or “biologically active agent composition” administered to a subject and, hence, a biological structure thereof, is of sufficient quantity to ameliorate one or more causes, symptoms, or sequelae of a disease or disorder. Such amelioration only requires a reduction or alteration, not necessarily elimination, of the cause, symptom, or sequelae of a disease or disorder.
The terms “delivery” and “administration” are used interchangeably herein, and mean and include providing a “biologically active agent” and/or “pharmacological agent” to a treatment site, e.g., damaged biological tissue, through any method appropriate to deliver the functional composition and/or agent or combination thereof to the treatment site.
The terms “patient” and “subject” are used interchangeably herein, and mean and include warm blooded mammals, humans and primates; avians; domestic household or farm animals, such as cats, dogs, sheep, goats, cattle, horses and pigs; laboratory animals, such as mice, rats and guinea pigs; fish; reptiles; zoo and wild animals; and the like.
The term “comprise” and variations of the term, such as “comprising” and “comprises,” means “including, but not limited to” and is not intended to exclude, for example, other additives, components, integers or steps.
The following disclosure is provided to further explain in an enabling fashion the best modes of performing one or more embodiments of the present invention. The disclosure is further offered to enhance an understanding and appreciation for the inventive principles and advantages thereof, rather than to limit in any manner the invention. The invention is defined solely by the appended claims including any amendments made during the pendency of this application and all equivalents of those claims as issued.
Referring now to
Referring to all embodiments disclosed herein, it should be noted that prior to deployment of the delivery wire 100, a guide wire can be used to position any element of the system disclosed herein, including a delivery catheter 202, guide catheter 204, and delivery wire 100 into the preferred position within a vessel or other interior.
The “bodies” (or “elements”) referred to herein can comprise a mesh comprising a metal alloy, such as a nickel-titanium alloy, or other suitable expandable biocompatible material, such as a polymer. The mesh construct of the distal 104 and proximal 102 bodies are preferably sized and configured to capture embolic material and, hence, reduce the risk of distal embolization of portions of a vessel occlusion during removal.
According to the invention, the “bodies” (or “elements”) referred to herein, e.g., the distal 104 and proximal 102 bodies depicted in
According to the invention, the “bodies” (or “elements”) referred to herein, e.g., the distal 104 and proximal 102 bodies depicted in
Referring back to
Such releasable engagement can be achieved, for example, by using breakable connection 108, which in some embodiments, can be an electrolytically or heat removable/disconnectable connection or mechanical connection that can be selectively disconnected by the clinician.
In the case of an electrolytically or heat removable/disconnectable connection, for example, the clinician can apply a current to the connection, (in embodiments via the wire which can be conductive) wherein the electrical current breaks or melts the connection. The connection can include, without limitation, a breakable connection 108, linking a proximal body 102 to the delivery wire 100, that can be eroded and/or disintegrated through the application of electrical current.
The breakable connection 108 can be preloaded onto the retrieval device in order to secure the proximal body 102 in a preferred location and/or configuration.
The breakable connection can have a plurality of shapes and designs, including, but not limited to a straight post extending from the delivery wire 100 to the proximal 102 or other body, a loop configuration of the breakable connection passing through the material of the proximal 102 or other body, and/or a “nail” configuration in which a straight post extends from the delivery wire to the proximal 102 or other body, wherein the post has an enlarged end, or nail head, within the body that can be eroded by the application of electric current to release the body.
Embodiments of the present invention include a proximal 102 or other body that can be secured to the delivery wire 100 using more than one breakable connection 108. In an example, a proximal body 102 can be secured with multiple breakable connections, each having a different length and a different release threshold, allowing the breakable connections to be sequentially released.
According to the invention, in some embodiments, more than one proximal body can be secured to the delivery wire 100 using a breakable connection 108. Melting of a breakable connection can be caused by the application of electrical current, fluid, and/or chemical compounds. Melting can occur in a physical member that is used to secure the proximal or distal body and/or can occur within an adhesive that binds the physical member to the proximal, and/or the delivery wire 100.
Breakable connection techniques and methods, including, but not limited to those shown in U.S. Pat. Nos. 5,683,451, 5,855,578, 6,245,076, 8,273,116. and U.S. patent application Pub. Nos. 2007/0100414A1, 2009/0062726A1, and 2010/0268251A1, can be used to release a proximal body and/or distal body, as described herein.
In the case of a mechanically breakable connection, the breakable connection 108 can be made of a suture, brace, thread or other material that is able to be broken upon application of force to the breakable connection 108.
According to the invention, in some embodiments, the distal motion of a catheter, such as the delivery catheter, with a force above the threshold holding force of the breakable connection 108 can cause the connection 108 to break or release, thus allowing the proximal body 102 to move along the wire in the manners described herein. The “bodies” referred to herein can be of various geometric shapes including a disc or sphere.
According to the invention, in some embodiments, the distal body 104 and/or proximal body 102 can be an inflatable device, including but not limited to an inflatable balloon.
In some embodiments of the invention, a retrieval device, as described herein, can include a distal body 104 and a proximal body 102 made of differing materials, for example a proximal body 102 can be an inflatable balloon and a distal body 104, on the same retrieval device, can be made of a mesh material.
According to the invention, in some embodiments, by adjusting the manufactured radial force, body diameter, and strength of the bodies, foreign body extraction, as described herein, can also be used for the removal of stones, pulmonary emboli, or some other type of obstruction.
In some embodiments, a proximal body 102 and/or distal body 104 can have variable radial force, or stiffness across sub-regions of the body itself. For example, the upper hemisphere of a spherical body can have a different radial force characteristic than the lower hemisphere of the body.
In some embodiments, the proximal and distal bodies 102, 104 are substantially the same in construction.
In some embodiments, the proximal and distal bodies 102, 104 are heterogeneous, having different compositions and characteristics including, without limitation, shape, size (e.g., thickness, diameter), configuration, pore size (e.g., mesh pore size), coating, or some other differing characteristic.
According to the invention, in some embodiments, the proximal and/or distal bodies 102, 104 can have anti-platelet, or some other type of, coatings to reduce adhesion and provide a less thrombogenic environment during clinical application.
According to the invention, the proximal and/or distal bodies 102, 104, and any material (e.g., wires) between these bodies, can also be coated with control release agents including, but not limited to, thrombolytic agents and the aforementioned pharmacological agents. Suitable coatings are disclosed in Applicant's co-pending U.S. application Ser. No. 18/638,483, which is incorporated by reference herein in its entirety.
Referring back to
The “delivery catheter” 202 referred to herein can be referred to as a microcatheter and can form a plurality of shape configurations based on the clinical application in which it is used, for example, which type of vessel the delivery catheter is used within, the vessel size, the vessel shape, or some other application characteristic.
In some embodiments, a delivery wire and/or hypo tube can be used within a microcatheter. For purposes of this disclosure, the microcatheter 202 is commonly called a “delivery catheter”, although it should be understood that the terms can be used interchangeably.
Referring now to
According to the invention, in some embodiments, a guide catheter 204 is navigated into place over a guide wire.
According to the invention, the delivery catheter 202 can be passed through an object, such as a thrombus or clot 212, the bodies 102, 104 can be released from the delivery catheter 202 either by retracting the delivery catheter 202 or advancing the wire 100, such that expandable bodies are no longer restrained by the delivery catheter 202.
According to the invention, the distal body 104 remains fixed to the delivery wire 100, but the proximal body 102 (once released from its releasable engagement) can freely move along its axis and longitudinally along the delivery wire 100 when pushed by the delivery catheter 202.
According to the invention, the term “pushing,” as used herein in connection with the delivery wire 100 means relative pushing of the body (210 or 102 once expanded). That is, the retraction of the delivery wire 100 while the delivery catheter 202 is kept in place can serve to move the proximal body 102 axially along the wire. The term “pushing” as is used herein will refer to both forms of movement mentioned above.
Once the proximal and distal bodies are positioned adjacent to both sides of the clot (which has been referred to herein as “surrounded” or “surrounding” the clot) by movement of the proximal body 102, the clot can be removed by retrieving the device from the cavity and pulling the clot free. The terms “clot,” “thrombus,” “occlusion,” “occlusive substance” and “foreign body” can be used interchangeably herein.
According to the invention, the freedom of movement of the proximal body 102 on the delivery wire 100 axially can allow for the compression of the occlusive substance and obviate the need for pre-measuring or estimating the required distance between the distal and proximal bodies prior to entering the vessel 200; sizing can take place in situ within the vessel 200 upon the interventionist encountering it.
In some embodiments, the retrieval device can consist of a distal body (also referred to herein as a distal element) 104 and a proximal body (also referred to herein as a proximal element) 102, each of which, in some embodiments, can comprise collapsible geometric forms.
Although the distal and proximal bodies are presented for diagrammatic purposes as spherical, the distal and proximal bodies can also be other geometric forms such as a disc, cone, oblong-shaped form, etc.
As indicated above, the distal and proximal bodies can comprise a mesh structure. The mesh cell size can be manufactured to have different sizes based on factors such as the expected properties of the target foreign matter to be removed, such as the density of the matter.
In some embodiments, the distal body 104 is mounted on a delivery wire 100 such that it remains fixed.
In some embodiments, the mounting of the proximal body 102 occurs by running the wire through one of the mesh openings. In other embodiments, the proximal body 102 itself can have an opening through which the wire can pass. In either case of mounting the proximal body 102, the body 102 is able to slide along the wire in an axial direction along the wire. This can be referred to herein as “slidably mounted.”
According to the invention, in some embodiments, the distal body 104 can be slidably mounted in the way described above.
As described above, the proximal body 102 can be detachably mounted (thus releasably engaged) on the delivery wire 100 using mechanical, electrolytic or some other type of control release format.
In some embodiments, the proximal body 102 is allowed to slidably move along the delivery wire 100 once released while the distal body 104 remains fixed.
In other embodiments, both the proximal and distal bodies 102, 104 can be releasably engaged to the delivery wire 100 and, thus, slidable or movable along the delivery wire 100 after release.
Still in other embodiments, the proximal body 102 can comprise a plurality of bodies, and the distal body 104 can also comprise a plurality of bodies.
The mesh material of the distal and proximal bodies 102, 104 can have advantages over other material types, including, but not limited to inflatable balloons. Inflatable material can be susceptible to rupture, such as that caused by over inflation.
The clinical setting can also be associated with complications related to the use of inflatable balloons within a lumen. For example, a calcified thrombus can increase the risk of balloon rupture.
In another example, if an occlusion itself includes metallic material, this can also increase the risk of rupture or other malfunction of an inflatable balloon. Rupture of a balloon can in turn increase the risk of an air embolus forming within the vessel or cavity of intervention.
According to the invention, in some embodiments, the mesh material of the distal and proximal bodies can allow for the bodies 102, 104 to expand upon release to the diameter and configuration of the cavity in which it is placed, such as a vessel 200 in which a thrombus 212 is located.
According to the invention, such meshes can be made of a shape memory substance such as nitinol. By way of example, a body made of nitinol mesh can expand to a first dimension outside of a vessel 200 or catheter, but can be designed to expand to a continuum of smaller dimensions than the first dimensions corresponding to different lumen sizes. In this way the bodies 102, 104 can fit the unique variations in diameter of a lumen at the point of release and/or point of placement near an occlusion, such as a thrombus.
According to the invention, a mesh material can also allow for improved distal flow during an intervention. The irregularity and/or texture of an expanded mesh material can facilitate the mesh material becoming entangled or otherwise incorporated with a clot or occlusive substance, thereby increasing adhesion of the distal and/or proximal body with the occlusion and facilitating its removal.
In some embodiments, when the proximal body 102 is released, it can be free to move/slide on its axis along the delivery wire 100 in a longitudinal and/or rotational fashion.
Referring now to
As depicted in
Alternatively, the delivery catheter 202 can be used to hold the proximal body 102 in a fixed position while the delivery wire 100 is withdrawn thus moving the fixed distal body 104 towards the proximal body 102 and ultimately capturing and compressing the thrombus 212.
As depicted in
In embodiments of the present disclosure, the retrieval device can be employed as part of the removal of an occlusive object or substance from a human vessel, such as performing arterial thrombectomy. This procedure can include the following generalized steps.
Referring to
The proximal body 102 having been released is then advanced distally (shown in
The retrieval device can remove both organized and unorganized thrombi since, in some embodiments, the bodies of the retrieval device do not need to be incorporated into the thrombus 212 to affect its removal.
The retrieval device can also remove calcified, atherosclerotic material since, in some embodiments, the bodies of the retrieval device do not need to be incorporated into the material to affect its removal.
The retrieval device can be used centrally and peripherally by selecting the appropriate diameter and characteristics of the bodies 102, 104, such as appropriate radial force or stiffness, appropriate shape, whether the bodies 102, 104 are substantially identical or homogenous, mesh opening size in the bodies, and the like.
The methods, system and apparatus, as described herein, can have a plurality of sizes loaded within a common catheter, and a clinician can self-load, for example, different and/or additional proximal bodies, as described herein, rather than having to fully replace a deployed catheter for a second catheter-based device and system. This can reduce manufacturing costs and improve intervention efficiency.
Referring now to
In some embodiments, the incorporation structure is part of the delivery wire 100 of the retrieval device, in other embodiments it is separate.
As depicted in
In the case where the incorporation structure is part of the delivery wire 100, the segment will be referred to herein as the “active segment” while the remainder of wire will be referred to as the “delivery segment.” The active segment is the segment having a section intended to span the length of the thrombus 212.
In some embodiments of the invention, the active segment comprises a cross-sectional shape that differs from the delivery segment.
In some embodiments, the delivery segment contains a suture material 1500 between the proximal 102 and distal 104 bodies. The suture material 1500 gathers and moves along the delivery wire 100 as the proximal body 102 is advanced. Once the proximal body 102 is in position, the suture material 1500 will be gathered in the area between the two bodies which will enhance incorporation characteristics of the active area. Note that the active area in the above example is the area between the two bodies 102, 104, which in this case, has suture material 1500 gathered therebetween.
As mentioned above, in some embodiments, the incorporation structure can be an additional expandable structure between the proximal 102 and distal 104 bodies that expands and incorporates into the thrombus 212. The incorporation structure can comprise other mechanisms to enhance thrombus-incorporation, such as flanges, hooks, sutures, sinusoidal wire 1600, or some other material configuration.
In some embodiments, the delivery wire 100 can include a distal body 104 that can be affixed, mounted, adhered or otherwise connected to a delivery wire 100 or hypo tube as described herein.
According to the invention, prior to deployment, such as a thrombectomy, the distal body 104 can be affixed, mounted, adhered or otherwise connected to the delivery wire 100 or hypo tube in a collapsed or compressed state. Compression of the distal body 104 can be provided by the delivery catheter 202, and/or multiple catheters which surround the distal body 104 and delivery wire 100 (as described herein).
Once the delivery catheter 202 is inserted through an object, such as a thrombus, the distal body 104 can be released from inside the delivery catheter 202 as described herein, thus expanding.
Following removal of the delivery catheter 202, suction can be applied to the thrombus or other blockage. (It is to be noted that a suction step, as described herein, can be applied to any of the embodiments of this disclosure, and can be applied through the guide catheter, access catheter, specialized suction catheter, or some other type of catheter).
By way of example, the Seldinger technique can be initiated using a large bore suction catheter that is advanced over the delivery wire 100 (or a guide wire) and positioned proximal to the thrombus 212, with the distal body 104 distally positioned to the thrombus. Suction can be applied to remove all or a portion of the thrombus.
According to the invention, positioning of the distal body 104, on the distal side of the thrombus, can be used to retract the thrombus in the direction of the suction device, thereby increasing the effectiveness of the suction device in removing the thrombus.
The distal body 104 preferably provides distal protection from distal embolization during the suction device's placement and/or during the suctioning procedure.
Note that in the above example, a proximal body has not yet been included in the procedure.
There are situations and thus embodiments where an optional proximal body 102 can be added to the procedure, for example, by slidably mounting a proximal body 102 to the delivery wire 100. As such, in embodiments the inclusion of a proximal body 102 is optional.
In some clinical scenarios the suction procedure can result in only a partial removal of the thrombus 212 or other obstruction. In such scenarios, mechanical removal of the thrombus 212, using a distal body and an added proximal body 102, can be advantageous and/or required.
Following the application of suction or aspiration within the guide catheter 700, a proximal body 102 can be added to the delivery wire 100, where this proximal body 102 is proximal to the thrombus 212 or other obstruction. Once the proximal body 102 is placed on the delivery wire 100, it can be advanced towards the distal end of the delivery wire 100 by advancing the delivery wire 100.
In another example, the proximal body 102, in a restrained position, can be advanced towards the distal end of the delivery wire 100 using a hypo tube that is placed within the delivery catheter 202 over the delivery wire. As the hypo tube is pushed towards the distal end of the delivery wire 100, the proximal body 102 can be moved axially to a desired location.
Once the proximal body 102 is in the desired physical position, relative to the thrombus 212 or other obstruction, the proximal body 102 can be released from inside the delivery catheter 202 to form the expanded proximal body 102 in a manner already described herein.
According to the invention, the coaxially placed hypo tube can be pushed forwards and used to physically advance the proximal body 102 to ultimately capture and compress the thrombus 212. Once the thrombus 212 is captured/compressed between the distal body 104 and the proximal body 102, the entire retrieval device can be removed from the body via coaxially placed catheters/tubes thus permitting removal of the thrombus 212 from its prior resting place within the vessel.
Referring now to
As depicted in
According to the invention, the proximal tether 1700 can run parallel and within the delivery catheter (not shown) or, as depicted in
Referring now to
Movement of the proximal body 102 via the proximal tether, in the proximal direction, is the same as mentioned above. In this embodiment, the interventionist can pull the end of the distal tether 1720 to move the proximal body 102 adjacent to the opening 117B, which results in a distal movement of the proximal body 102 without the need for distal movement via the delivery catheter 202 as described herein.
In addition to the steps of deployment mentioned above, the following steps can also or alternatively be followed for using the retrieval device in embodiments.
According to the invention, the delivery wire 100 with restrained proximal 102 and restrained distal 104 bodies thereon is inserted into and through the delivery catheter 202 with the tip emerging the delivery catheter 202 as depicted in
Referring now to
Due to mesh construct of the proximal 102 and distal 104 bodies, which are now deployed, anterograde flow into vessels will be re-established with protection (established via the expanded proximal 102 and distal 104 bodies) from distal embolization of occlusion when flow is re-established.
According to the invention, suction can be applied to the access catheter 1900 at this point.
The proximal body 102 can be released from its releasable engagement 108 as described herein, while the distal body 104 remains fixed to the wire.
With both the proximal 102 and distal 104 bodies providing protection (most commonly initially in an M2 branch for an M1 occlusion or covering the M1 bifurcation for an ICA terminus) an interventionist can slowly pull the delivery wire 100 in a proximal direction. This will draw both bodies proximally (see
According to the invention, once the distal body 104 opens at the M1 bifurcation, both superior and inferior M2 protection has been established (see
According to the invention, using a proximal tether 1700 and a distal tether 1702 that connect to the proximal body 102 and exit from the delivery wire 100 either via an opening in the outer surface or via the opening on the end of the delivery wire 100 (see
If the initial placement of the proximal body 102 is determined to be too far in the distal direction, the interventionist can use the proximal tether 1700 that is attached to the proximal body 102 to pull the proximal body 102 back in the proximal direction to place it farther from the distal end of the retrieval device. This allows the interventionist to adjust the proximal body's position along the wire 100 instead of only being able to advance the proximal body 102 in the distal direction.
By way of example, the proximal body 102 can have a Kevlar tether that exits the delivery wire (or hypo tube) 100 at an opening distance about 1.0 cm-2.0 cm proximal to the proximal side of the proximal body 102 to which it is attached. Therefore, while the two bodies are initially adjacent to each other, the proximal body 102, once electrolytically detached, can be withdrawn a distance proximally along the delivery wire 100 axis 1.0-1.5 cm by pulling on the proximal tether 1700. (All distances herein can be adjusted according to the need).
The proximal body 102 can be advanced by pushing it forward with the delivery catheter 202 and/or a second, distal tether 1702 can exit the wire at opening 117B distally to the proximal body 102 which, when pulled, can pull the proximal body 102 distally back towards the distal body and adjacent to the opening 117B.
Thus, by pulling proximal tether 1700 and/or the distal tether 1702 the proximal body 102 can slide backwards and forwards along the delivery wire 100. In this example, this configuration provides the proximal body 102 with 1.0 cm-1.5 cm of travel distance back and forth along the delivery wire 100. Despite anterograde flow, the distal body 104 can provide protection against distal embolization of loosened/floating occlusion thus eliminating/reducing the risk of distal embolization of this material (see
Once the thrombus 212 has been removed/evacuated through the access catheter 1900, the proximal and distal bodies can be removed by withdrawing them through the delivery catheter 202. This process will also mechanically draw any thrombus 212 that sits on the tip of the access catheter 1900 (cleans the catheter tip) into the catheter 1900 so that it does not embolize off the catheter tip and back into the intracranial circulation (see
Referring now to
Referring simultaneously to
The retrieval device 2800 further comprises a second unit 2892 that includes an aspiration catheter 2835 having a suction source such as, for example, a syringe 2837, a one-way valve 2839 and a port 2842 (
As discussed in detail below, in some embodiments, the distal end 2846 of the aspiration catheter 2835 comprises a beveled configuration.
In some embodiments, the one-way valve 2839 is configured to direct suction through the aspiration catheter 2835.
According to the invention, for use during a procedure, the tip portion 2804 is placed into a delivery catheter 2848 and thereafter the delivery catheter 2848 is inserted into the aspiration catheter 2835, and follows through to port 2842, so that at least the tip portion 2804 projects distally from a distal end 2846 of the aspiration catheter 2835.
In some embodiments, as depicted in
In some embodiments, the proximal end 2844 of the aspiration catheter 2835 is coupled to the second opening 2812j.
According to the invention, when the actuator 2815j is depressed, the valve hub 2842j is configured to receive the elongated member 2805 through the first opening 2810j and allow the elongated member 2805 to pass through the second opening 2812j and through the aspiration catheter 2835.
When the actuator 2815j is not depressed, the valve hub 2842j is configured to create a seal around a surface of the elongated member 2805.
In some embodiments, the suction source 2837 is coupled to a portion of the valve hub 2842j and is in pressure communication with the aspiration catheter 2835.
In accordance with aspects of the present invention, the retrieval device 2800 is configured to enable an operator to single-handedly operate/actuate the handle portion 2802 (using first, second and third physically manipulable interfaces such as, for example, knobs, sliders, buttons or other actuation mechanisms 2814, 2818 and 2820) in order to mechanically expand, contract, or move a proximal member 2806 and/or a distal member 2807, as further discussed below.
In some embodiments, a first slider, knob, button, or other actuation mechanism 2814 is configured to mechanically expand or mechanically contract the proximal member 2806, a second slider, knob, button, or other actuation mechanism 2818 is configured to mechanically expand or mechanically contract the distal member 2807, and a third slider, knob, button, or other actuation mechanism 2820 is configured to axially move the proximal member 2806 relative to the distal member 2807, to axially move the proximal member 2806 while maintaining the distal member 2807 stationary, or to axially move the distal member 2807 while maintaining the proximal member 2806 stationary.
In some embodiments, it is preferred that the proximal and distal members 2806, 2807 disclosed herein are not self-expandable or self-contractable but, rather, only expand or contract when a pressure is manually applied or released using the physically manipulable interfaces (such as, for example, knobs, sliders, buttons or other actuation mechanisms) integrated into the handle 2802.
In some embodiments, as depicted in
In another embodiment, as depicted in
In some embodiments, as depicted in
Also, in some embodiments, as depicted in
In some embodiments, pressing the physically manipulable interface 2811j allows the user to move or slide the physically manipulable interface 2811j towards or away from the tip portion 2804 thereby increasing or decreasing the length of the delivery catheter 2848 passing through the valve hub 2842j.
Further, in some embodiments, as depicted in
In another embodiment, the handle 2802 comprises one or more actuation mechanisms to deliver one or more of the aforementioned pharmacological agents, such as plasminogen activator (tPA), or medications to a vessel occlusion site, as described above, and/or activate aspiration while providing distal embolic protection via the structure and stationary position of the distal member 2807.
In some embodiments, a method of treatment would include infusing an aforementioned thrombolytic agent, e.g., tPA, into at least one lumen positioned within the aspiration catheter 2835.
In some embodiments, the infusion is performed at the outset of the pulmonary embolism or deep vein thrombosis treatment process, while the proximal and/or distal members 102, 104 or 2806, 2807 are still housed within the catheter, thereby covering the unexpanded proximal and/or distal members 102, 104 or 2806, 2807 in tPA.
Alternatively, the infusion is performed at the outset of the pulmonary embolism or deep vein thrombosis treatment process, while the proximal and/or distal members 102, 104 or 2806, 2807 are still housed within the catheter, directed through the distal end of the catheter, and injected directly into the clot prior to inserting and expanding the proximal and/or distal members.
In some embodiments, the catheter 2835 and handle 2802, in combination, are configured to deliver ultrasonic energy to a clot to accelerate lytic dispersion, drive medications deeper into the clot, speed the breakdown of the clot, and/or degenerate or unwind the fibrin quicker.
In some embodiments, the catheter 2835 comprises an ultrasonic core in parallel with the elongated wire extending axially through the catheter lumen. The ultrasonic core is in electrical communication with a control unit positioned external to the catheter.
The proximal end of the handle 2802 would preferably have one or more leads in electrical communication with the ultrasonic core that would extend outward from the handle 2802 and be configured to connect to the control unit.
During the pulmonary embolism or deep vein thrombosis treatment process, the ultrasonic energy would be activated, using the control unit, at the beginning of the treatment upon delivery of the medications, as described above.
In some embodiments, an ultrasonic core energy generator runs through the center of the catheter 2835.
In some embodiments, the ultrasonic core energy generator includes a control unit configured to manage the generator.
In some embodiments, a proximal end of the retrieval device 2800 includes leads, which plug into the control unit.
In accordance with some aspects of the present specification, the first and second units 2890, 2892 are manufactured as separate standalone units or devices. This is advantageous in that a physician can use the first unit 2890 with any third-party aspiration catheter.
In some embodiments, the aspiration catheter 2835 is available with a plurality of external diameters such as, but not limited to, 12 Fr, 16 Fr, 20 Fr, and 24 Fr (where Fr represents French scale or gauge system).
As indicated above, in some embodiments the distal end 2846 of the aspiration catheter 2835 comprises a beveled structure.
In some embodiments, the syringe 2837 has an exemplary, non-limiting, volume of 60.0 cubic centimeters.
In some embodiments, for use in treatment of pulmonary embolism a length of the delivery catheter 2848 is in a range of 80.0 cm to 160.0 cm, preferably 120.0 cm.
In some embodiments, for use in treatment of pulmonary embolism the aspiration catheter 2835 has different lengths for different external diameters. By way of example, an aspiration catheter of 16 Fr has a length in a range of 70.0 cm to 160.0 cm, preferably 112.0 cm, an aspiration catheter of 20 Fr has a length in a range of 60.0 cm to 150.0 cm, preferably 105.0 cm or 106.0 cm, and an aspiration catheter of 24 Fr has a length in a range of 50.0 cm to 130.0 cm, preferably 90.0 cm.
Also, in some embodiments, for use in treatment of pulmonary embolism (PE), the aspiration catheter of 20 Fr has a distal end or tip with a customizable 2700 bend whereas the aspiration catheter of 24 Fr has a flexible or bendable distal end or tip.
In some embodiments, for use in treatment of pulmonary embolism (PE), the suction source 2837 is a syringe having a volume ranging from 1.0 cc to 100.0 cc, and preferably a volume of 60.0 cc. In some embodiments, for use in treatment of deep vein thrombosis (DVT) a length of the delivery catheter 2848 is in a range of 40.0 cm to 120.0 cm, preferably 80.0 cm.
In some embodiments, for use in treatment of deep vein thrombosis a length of a 16 Fr aspiration catheter 2835 is in a range of 45.0 cm to 80.0 cm, preferably 65.0 cm. In some embodiments, for use in treatment of deep vein thrombosis, the suction source 2837 is a syringe having a volume ranging from 1.0 cc to 100.0 cc, and preferably a volume of 60.0 cc.
In some embodiments, for use in treatment of right heart/atrium, the 24 Fr aspiration catheter has a length of 90.0 cm. In some embodiments, for use in treatment of IVC/SVC (Inferior Vena Cava/Superior Vena Cava), the 24 Fr aspiration catheter has a length of 90.0 cm.
Referring now to
As depicted in
In some embodiments, at least one pressure transducer or sensor 2809 (such as, for example, a fiber-optic pressure sensor, electro-mechanical pressure sensor and hydraulic pressure sensor) is positioned at a distal end of aspiration catheter 2835.
In some embodiments, the pressure transducer(s) or sensor(s) 2809 are in the form of an elongated member that is co-extruded into the aspiration catheter 2835 so that the elongated member runs along a full length of the aspiration catheter 2835. In some embodiments, the pressure transducer(s) or sensor(s) 2809 are in electrical communication with electronic circuitry located in a handle 2802 of the first unit 2890.
In some embodiments, the handle 2802 includes a pressure display 2821.
In various embodiments, the pressure transducer(s) or sensor(s) 2809 are configured to sense a pressure change or drop and, in particular, provide the physician with an indication that, as the occlusion is removed, there is an associated change of pressure indicative of a right-side drop in right heart pressure. A right-side drop in right heart pressure indicates that a problematic occlusion is being successfully removed.
Referring again to
During insertion of the retrieval device 2800 into the blood vessel, the distal end 2852 of the tip portion 2804 enters the blood vessel first and is placed in close proximity to the occlusion within the blood vessel by using the handle 2802 to maneuver the insertion of the tip portion 2804 in a desired position in the blood vessel.
The tip portion 2804 comprises a distal member, element or body 2807, which in at least one embodiment, is a mechanically expandable, rigid anchor fixedly attached proximate the distal end 2852 of the tip portion 2804, and a proximal member, element or body 2806, which in at least one embodiment is a mechanically expandable pusher ball that is slidably mounted proximate the proximal end 2850 of the tip portion 2804. The mechanical expansion is in contrast to a non-mechanical expansion occurring because a shape memory material is naturally configured to adopt a pre-defined shape without mechanical force requiring to be applied.
In some alternate embodiments, the proximal element or body 2806 is configured as a mechanically expandable, rigid anchor fixedly attached proximate to the proximal end 2850 of the tip portion 2804 while the distal element or body 2807 is configured as a mechanically expandable pusher ball that is slidably or moveably mounted proximate the distal end 2852 of the tip portion 2804.
In various embodiments, the proximal and distal elements 2806, 2807 are substantially curved structures.
In some embodiments, each of the proximal and distal elements 2806, 2807 is a three-dimensional (3D) shape.
In some embodiments, the proximal and distal elements 2806, 2807 are independent of one another yet mounted on a single delivery system or retrieval device 2800.
In some embodiments, the proximal member 2806 and the distal member 2807 are braided structures made of interwoven wires such that each structure has a plurality of open areas (allowing egress from outside the member into the internal volume of the member) formed by the braid. The open areas, relative to the total surface area of the proximal or distal member 2806, 2807, are in a range of 1% to 99% of the total surface area.
In some embodiments, the proximal member 2806 has a greater percentage of open surface area than the distal member 2807, thereby allowing the proximal member 2806 to capture more clot material and the distal member 2807 to function more as a barrier to material flowing away from the device.
According to the invention, the proximal member 2806 and/or distal member 2807 can be any shape, including linear, spherical, spheroid, elliptical, ellipsoid, conical, polygonal, cylindrical, stent, chalice cup, umbrella, concave structure, convex structure, half-sphere, sphere, windsock, dumbbell, star, polygon, lever, disc, or a combination of such shapes.
In some embodiments, as shown in
Alternatively or additionally, in some embodiments, the distal member 2807 is also structurally shaped similar to the proximal member 2806 in terms of including a first funnel having a first neck directed along the axis 2803 in a proximal direction and a second funnel having a second neck directed along the axis 2803 in a distal direction wherein the cup edges of the first funnel and the second funnel are attached, optionally, in the form of contiguous wires, across a center axis).
In some embodiments, when either of or both of the proximal element 2806 and/or the distal element 2807 is mechanically expanded, a proximal portion and a distal portion of the respective element expands first followed by a center portion.
In some embodiments, each of the respective proximal, distal and center portions of the proximal element 2806 and the distal element 2807 can expand at different rates. In some embodiments, the proximal element 2806 and the distal element 2807 can be heterogeneous, having different characteristics including, without limitation, radial force (as described further below), shape, size (for example, thickness, diameter), pore size (for example, mesh pore size or open areas as described above), and external coating.
In some embodiments, the proximal and distal elements 2806, 2807 can be substantially similar in terms of the compositions and characteristics.
In some embodiments, the proximal and distal elements 2806, 2807 have similar braided structures that transition from a substantially linear structure to a substantially disc structure, adopting one or more three dimensional geometric shapes (spherical, spheroid, elliptical, ellipsoid, conical, polygonal, cylindrical, stent, chalice cup, umbrella, concave structure, convex structure, half-sphere, sphere, windsock, dumbbell, star, polygon, lever, disk or a combination of such shapes) during the transition. That is, the proximal element 2806 is defined by a first braid structure while the distal element 2807 is defined by a second braid structure, wherein the second braid structure is equivalent to the first braid structure, in embodiments.
In other embodiments, the second braid structure is not equivalent to the first braid structure.
Referring now to
In some embodiments, the proximal portion 28021 has a denser braid relative to the distal portion 28041. That is, the proximal portion 28021 is defined by a braid or weave pattern that is more stiff, rigid, or dense as compared to the distal portion 28041.
In some embodiments, the proximal element 2806 has a braid or weave that results in an active radial expansion.
In some embodiments, the proximal portion 28021 represents 30%-70% of the total surface area of the proximal element 2806 while the distal portion 28041 represents 70%-30% of the total surface area of the proximal element 2806.
As depicted in
In some embodiments, the distal element 2807 has a braid or weave that results in an active radial expansion. In some embodiments, the distal portion 28121 represents 30-70% of the total surface area of the distal element 2807 and the proximal portion 28101 represents 70-30% of the surface area of the distal element 2807.
Thus, in some embodiments, the proximal element 2806 is defined by a first braid structure while the distal element 2807 is defined by a second braid structure, wherein the second braid structure is equivalent to the first braid structure rotated 180.0 degrees.
In some embodiments, the different braid structures enable scraping of unwanted material or occlusion from a vessel wall as well as effective trapping of the unwanted material or occlusion within and/or between the proximal and distal elements 2806, 2807 so that the material or occlusion is easily removed.
In some embodiments, the tip portion 2804 is at least partially enclosed within the delivery catheter 2848 (as shown in view 2870 of
As stated above, in some embodiments, the distal element 2807 can be curved and take the form of a cylinder, stent, chalice cup, umbrella, concave structure, half-sphere, sphere, windsock, dumbbell, star, polygon, lever, or any other suitable shape configured for holding an occlusion and aiding retrieval of the occlusion.
In some embodiments, the elongated member 2805, including the tip portion 2804, comprises four flexible telescoping tubes, that when manipulated together enable an operator/doctor to expand or contract the distal and proximal elements 2807, 2806 and move the proximal element 2806 axially, relative to the distal element 2807 and vice versa, in order to dislodge and remove the occlusion.
View 2874 of
In some embodiments, the proximal element (pusher ball) 2806 is configured to move relative to the distal element (rigid anchor) 2807 via manipulation of the flexible telescoping tubes to enable dislodging and removal of the occlusion, as is explained in detail with reference to
View 2876 of
In some embodiments, the distal and/or proximal elements 2807, 2806 are fabricated from a Nitinol® wire mesh having a plurality of mesh pores, lattices or cells.
In some embodiments, the distal and/or proximal elements 2807, 2806 comprise inflatable devices including, but not limited to, inflatable balloons.
In some embodiments, the distal and proximal elements 2807, 2806 are fabricated from different materials.
In some embodiments, the distal element 2807 comprises a wire mesh while the proximal element 2806 is an inflatable balloon.
In some embodiments, the distal element 2807 comprises an inflatable balloon while the proximal element 2806 is a wire mesh.
In some embodiments, each of the proximal element 2806 and the distal element 2807 can be characterized by their ability to apply a variable radial force by virtue of the mechanical expansion being applied to each structure and the elements' stiffness or rigidity across sub-regions or portions of the respective elements 2806, 2807. By way of example, in some embodiments, the expansion of each of the proximal and distal elements 2806, 2807 to a first size (defined by an area or volume encompassed by the element) can be characterized by a first radial force that first size can apply to surrounding materials.
The expansion of each of the proximal and distal elements 2806, 2807 to a second size (defined by an area or volume encompassed by the element that is larger than the first size) can be characterized by a second radial force that second size can apply to surrounding materials, where the second radial force is different from the first radial force.
In some embodiments, each of the first and second radial forces are in a range of 5.0 newtons to 25.0 newtons, preferably 10.0 newtons to 14.0 newtons.
According to the invention, the mechanical expansion allows for the intermittent, controlled expansion of the proximal and distal elements 2806, 2807 so that they can adopt and retain the shape of a first size (having a first area or volume), a second size (having a second area or volume), a third size (having a third area or volume), or a fourth size (having a fourth area or volume) under the control of the user and throughout the length of a procedure where the fourth size is bigger than the third size which is bigger than the second size which is bigger than the first size.
In some embodiments, each of the proximal element 2806 and the distal element 2807 can be characterized by their ability to resist an application of a radial force, thereby maintaining its expanded shape, by virtue of the mechanical expansion being applied to each structure and the elements' stiffness or rigidity across sub-regions of the respective elements 2806, 2807. By way of example, in some embodiments, the expansion of each of the proximal and distal elements 2806, 2807 to a first size (defined by an area or volume encompassed by the element) can be characterized by an ability to resist (and therefore avoid collapse or compression of the first size) from a first radial force.
The expansion of each of the proximal and distal elements 2806, 2807 to a second size (defined by an area or volume encompassed by the element that is larger than the first size) can be characterized by an ability to resist (and therefore avoid collapse or compression of the second size) from a second radial force that is different from the first radial force.
In some embodiments, each of the first and second radial forces are in a range of 5.0 newtons to 25.0 newtons, preferably, 9.0 newtons to 20.0 newtons, more preferably, 10.0 newtons to 14.0 newtons.
According to the invention, the mechanical expansion allows for the intermittent, controlled expansion of the proximal and distal elements 2806, 2807 so that they can adopt and retain the shape of a first size (having a first area or volume), a second size (having a second area or volume), a third size (having a third area or volume), or a fourth size (having a fourth area or volume) under the control of the user and throughout the length of a procedure where the fourth size is bigger than the third size which is bigger than the second size which is bigger than the first size.
It should further be appreciated that at least one of the proximal and distal elements 2806, 2807 are adapted to not collapse or compress when positioned against blood flow that applies a hydrostatic pressure in a range of 80.0 mm Hg to 250.0 mm Hg. This is particularly valuable in arterial clot removal where the hydrostatic pressure level often causes other structures, particularly self-expanding structures, to compress or collapse.
In some embodiments, a physician uses any of the embodiments disclosed herein by a) placing the distal element distal to the occlusion, b) placing the proximal element proximal to the occlusion, c) expanding each of the proximal and distal elements to a diameter, width, or volume that is greater than or equal to the diameter, width or volume of the vessel lumen it is positioned within of vessel (if greater than, it can be equal to or up to 150%, preferably around 110% to 130%, more preferably 120%), d) positioning the thrombus between the distal and proximal elements, e) applying aspiration, f) moving the proximal element to pull the thrombus to the catheter, g) partially collapsing the proximal and distal elements to move both toward the catheter, h) collapsing both elements to pull them back into the catheter, with the thrombus, and (i) removing the catheter from the patient.
According to the invention, the distal element can optionally act as embolic protection to protect against clot material breaking free and flowing away from the procedure site.
According to the invention, the proximal element 2806 and/or distal element 2807 can comprise at least one outer coating, such as described in detail in Applicant's Co-pending U.S. application Ser. No. 18/638,483, which is incorporated herein in its entirety.
As set forth in detail in Co-pending U.S. application Ser. No. 18/638,483, can comprise a composition that is adapted to facilitate release of an occlusion from a vessel luminal wall during clinical application.
As also set forth in Co-pending U.S. application Ser. No. 18/638,483, the outer coating can also comprise a biodegradable polymer composition comprising at least one pharmacological agent that is adapted to ameliorate and/or facilitate amelioration of tissue damage to the endothelial luminal wall of an obstructed vessel in vivo, such as tissue damage to an endothelial luminal wall caused by an occlusion and/or removal thereof.
According to the invention, the biodegradable polymeric composition can comprise one of the aforementioned biodegradable polymers.
Thus, in some embodiments, the biodegradable polymeric composition comprises poly(glycerol sebacate) (PGS), poly(glycerol-co-sebacate acrylate) (PGSA), poly(lactic-co-glycolic) acid (PLGA), poly(ε-caprolactone-co-L-lactic) acid (PCL-LA), poly(polyol sebacate) (PPS), poly(xylitol sebacate) (PXS) or poly(xylitol glutamate sebacate) (PXGS).
In a preferred embodiment, the biodegradable polymeric composition comprises poly(glycerol sebacate) (PGS).
As also set forth in Co-pending U.S. application Ser. No. 18/638,483, the pharmacological agent can also comprise one of the aforementioned pharmacological agents.
Thus, in some embodiments, the pharmacological agent comprises an anti-inflammatory, such as an alkaloid, a 5-lipoxygenase (5-LO) inhibitor, a phospholipase A2 (PLA2) inhibitor, a non-steroidal anti-inflammatory and a steroidal anti-inflammatory.
In some embodiments, the pharmacological agent comprises an antibiotic, such as an aminoglycoside, cephalosporin, and chloramphenicol.
In some embodiments, the pharmacological agent comprises an antibiotic, such as an antiplatelet, such as an acetylsalicylic acid, clopidogrel, prasugrel, and ticagrelor.
As also set forth in Co-pending U.S. application Ser. No. 18/638,483, the pharmacological agent can also comprise a biologic that is specifically adapted to induce remodeling of damaged tissue and/or regeneration of new tissue structures, such as, without limitation, (i) a growth factor, e.g., transforming growth factor-β (TGF-β), basic fibroblast growth factor (bFGF), and vascular endothelial growth factor (VEGF); (ii) a glycosaminoglycan (GAG), e.g., heparin and hyaluronic acid; and (iii) an extracellular vesicle, e.g., exosome.
Referring back to
Having a distal member that is less susceptible to collapse and/or more resistant to force, ensures that the distal member can anchor and fix the device within the vessel and provide the opposing leverage to ensure the proximal member, when axially moved, can pull the clot material toward the open catheter.
In alternate embodiments, however, the proximal element 2806 is rigid and holds/maintains a predefined shape after expansion while the distal element 2807 is relatively more mobile than the proximal element 2806. In such embodiments, the degree of fixation achieved by the proximal element 2806 is greater than that achieved by the distal element 2807.
Consequently, in such embodiments, the proximal element 2806 is less susceptible to collapse and/or more resistant to force, ensuring that the proximal element 2806 can anchor and fix the device within the vessel and provide the opposing leverage to ensure the distal element 2807, when axially moved, can pull the clot material toward the open catheter.
Fixation can be achieved by means of radial opposition against a patient's vessel wall, engagement within or beyond a distal portion of an occlusion requiring removal, deployment around distal anatomical features (such as a vascular bifurcation or curve in the vasculature), or any combination of these.
Aspects that can selectively enhance or impede the relative fixation enabled by the proximal and distal elements 2806, 2807 include radial force or stiffness, expanded diameter, braid density, braid wire size, deployed length, deployed shape, wire geometry and surface finish, surface treatments and coatings, or other means that allow for amplification or dampening of frictional engagement of the elements 2806, 2807 with the occlusion and surrounding vasculature.
In some embodiments, the proximal element 2806 is equally or less stiff/rigid than the distal element 2807 by a ratio of less than or equal to 1:10.
In some embodiments, the relative stiffness or rigidity relationship is inverted with the distal element 2807 being equally or less stiff than the proximal element 2806 by a ratio of less than or equal to 1:10.
By modulating the manufactured relative radial force, stiffness or rigidity of the proximal and distal elements 2806, 2807, a desired balance of relative anchoring force to maceration potential can be achieved.
As previously stated, higher stiffness, rigidity or degree of fixation of the distal element 2807, relative to the proximal element 2806, provides an effective anchoring function when positioned within a vascular system or non-vascular structures. During a procedure, the anchored distal element 2807 provides an opposing anchoring force when the proximal element 2806, having relatively lesser stiffness, rigidity or degree of fixation, is moved or pushed axially towards the distal element 2807 to dislodge an occlusion. This provides an operator with an improved ability to apply pressure, through the pushing manipulation of the proximal element 2806, in order to dislodge the occlusion.
Thus, in various embodiments, by adjusting the characteristics (of the proximal and distal elements 2806, 2807) such as the radial force, shape, size (for example, thickness, diameter), pore size (for example, mesh pore size in embodiments where at least one of the two elements 2806, 2807 is fabricated from a wire mesh) and external coating a desired stiffness, rigidity or flexibility of the retrieval device 2800 can be obtained. With the desired stiffness, rigidity or flexibility the retrieval device 2800 can be adapted to extract or remove a variety of obstructions such as, for example, stones, pulmonary emboli and deep vein clots.
The distal member thus comprises a higher degree of rigidity and greater degree of porosity as compared to the proximal member. This is achieved by the distal member having at least one of a shape, wire thickness, average pore size, total porosity, total open surface area to total surface area ratio, and/or coating that is different from the proximal member. As a result, when expanded to any number of a plurality of sizes, the distal member is preferably more resistant to changing its size or shape upon application of an external force as compared to the proximal member.
In some embodiments, that external force is in a range of 1.0 newton to 50.0 newtons and any increment therein, more preferably, 8.0 newtons to 20.0 newtons, even more preferably, 9.0 newtons to 15.0 newtons.
Additionally, as a result, when expanded to the same size as the proximal member, the distal member is preferably less porous, meaning that it has less open surface area relative to total surface area, than the proximal member.
In embodiments, the elongated member 2805, including the tip portion 2804, comprises a plurality of telescoping tubes (also referred to, alternatively, as shafts), such as 1-6 or preferably 4, which are also described with reference to
As depicted in
In some embodiments, the four tubes 2830, 2825, 2827 and 2816 are arranged as a coaxial array of telescopic tubes, all of which are designed to be able to move axially relative to one another.
In some embodiments, the first tube 2830 is concentrically positioned around the second tube 2825, the second tube 2825 is concentrically positioned around the third tube 2827, and the third tube 2827 is concentrically positioned around the fourth tube 2816.
In some embodiments, the four telescoping tubes 2830, 2825, 2827 and 2816 can be axially expanded or contracted relative to each other by using the handle portion 2802.
In an embodiment, the telescoping tubes 2830, 2825, 2827 and 2816 are made of a shape-memory nickel-titanium alloy; preferably, Nitinol®.
In some embodiments, the distal element 2807 has a proximal end 2856 and a distal end 2858.
As further depicted in
In some embodiments, the wire mesh 2813 is only attached at points 2834 and 2815, respectively, of an exterior surface of the fourth tube 2816 and the third tube 2827, while the remaining portion of the wire mesh 2813 is unattached and therefore free to expand or contract.
In some embodiments, in a non-expanded or collapsed state, the distal element 2807 (comprising a plurality of wires) forms a generally tubular wire mesh 2813 and is concentrically positioned around a lumen of the fourth tube 2816.
It should be appreciated that, while the term “tube” is used to describe the telescoping structures, any type of cylindrical, hollow wire, solid wire, or other elongated structure can be used and the term “tube” or “shaft” is just intended to cover each of these structures.
According to the invention, upon axial compression of the third tube 2827 relative to the fourth tube 2816, the wire mesh 2813 expands radially around the lumen of the fourth tube 2816. Similarly, upon axial decompression of the third tube 2827 relative to the fourth tube 2816, the wire mesh 2813 is induced to compress or contract radially around the lumen of the fourth tube 2816.
In some embodiments, in order to expand or contract the distal element 2807 the fourth tube 2816 is moved axially while the first, second and third tubes 2830, 2825, 2827 remain stationary.
In some embodiments, initial expansion of the distal element 2807, as induced by relative axial motion of the third tube 2827 and the fourth tube 2816, is such that the distal element 2807 first takes a shape similar to that of the proximal element 2806 (the shape of the proximal element 2806 being substantially elliptical, in one embodiment).
Further relative axial movement of the third tube 2827 and the fourth tube 2816 induces an inversion in at least a portion of the wire mesh 2813 such that the proximal end 2856 collapses inside the distal end 2858, forming a chalice or a cup/concave shape as depicted in
In some embodiments, a distance between the two attachment points 2834 and 2815 of the wire mesh 2813 ranges approximately from 1.0 mm to 100.0 mm.
Stated differently, relative axial movement of the third tube 2827 and the fourth tube 2816 causes the proximal end 2856 and the distal end 2858 to move closer to each other, the material comprising the distal element 2807 and extending between the ends 2856 and 2858 is compressed and therefore expands outward. In contrast, as the proximal end 2856 and the distal end 2858 move away from each other, the material comprising the distal element 2807 and extending between the ends 2856 and 2858 is stretched and therefore collapses down to, and elongates along, a body lumen. Thus, the distal element 2807 expands by having the proximal end 2856 move distally and contracts by having the proximal end 2856 move proximally relative to the distal end 2858.
In some embodiments, the anchor nose 2834 is configured as a corkscrew structure such that, as the tip portion 2804 is advanced towards a clot (within a vessel lumen) the tip portion 2804 is rotated to “screw into” and break up the clot material.
Referring now to
The distal end 2862 of the proximal element 2806 is fixedly attached to the second tube 2825 at a point 2828, while the proximal end 2860 is fixedly attached to the first tube 2830 at a point 2829 in both expanded and non-expanded states of the proximal element 2806.
In various embodiments, in a non-expanded state, the proximal element 2806 (comprising a plurality of wires) forms a wire mesh 2826 concentrically positioned around a lumen of the second tube 2825.
In some embodiments, a portion of the wire mesh 2826 is only attached at points 2828 and 2829, of an exterior surface of the second tube 2825 and the first tube 2830, respectively, while the remaining portion of the wire mesh 2826 is unattached and therefore free to expand or contract.
According to the invention, upon axial compression of the first tube 2830 relative to the second tube 2825, the wire mesh 2826 is induced to expand radially around the lumen of the second tube 2825.
Similarly, upon axial decompression of the first tube 2830 relative to the second tube 2825, the wire mesh 2826 is induced to compress or contract radially around the lumen of the second tube 2825.
In some embodiments, in order to expand or contract the proximal element 2806 the first tube 2830 is moved axially while the second, third, and fourth tubes 2825, 2827, 2816 remain stationary.
Stated differently, relative axial movement of the first tube 2830 and the second tube 2825 causes the proximal end 2860 and the distal end 2862 to move closer to each other, whereby the material comprising the proximal element 2806 and extending between the ends 2860 and 2862 is compressed and therefore expands outward.
In contrast, as the proximal end 2860 and the distal end 2862 move away from each other, the material comprising the proximal element 2806 and extending between the ends 2860 and 2862 is stretched and therefore collapses down to, and elongates along, a body lumen. Thus, the proximal element 2806 expands by having the proximal end 2860 move distally and contracts by having the proximal end 2860 move proximally relative to the distal end 2862.
In some embodiments, in an expanded state the proximal element 2806 approximates an elliptical shape wherein, at least a portion of the wire mesh 2826 lies approximately perpendicular to the lumen of the second tube 2825.
In some embodiments, a diameter of an expanded proximal element 2806 is approximately 18.0 mm.
In some embodiments, a fully expanded proximal element 2806 is substantially elliptical or disc shaped as depicted in
In some embodiments, a fully expanded proximal element 2806 can be substantially spherical shaped while in a transient or less expanded state the proximal element 2806 can take a substantially elliptical shape.
As previously discussed, in various embodiments, in an expanded state the proximal element 2806 can take the form of a cylinder, stent, chalice cup, umbrella, concave structure, half-sphere, sphere, windsock, dumbbell, star, polygon, lever, or any other suitable shape configured for aiding retrieval of the occlusion.
It should be appreciated that in an expanded state, in some embodiments, the proximal element 2806 can take on a first shape while the distal element 2807 can take on a second shape.
In some embodiments, the first shape is different from the second shape. In some embodiments, the first and second shapes are substantially similar.
Referring now to
In some embodiments, a distance between a distal end 2865 of the handle portion 2802 and the distal end 2852 of the tip portion 2804 is in a range of 0.5 mm to 110.0 cm, preferably 1.0 mm to 100.0 mm.
As depicted in
The fourth tube 2816 is connected to the distal element 2807 at point 2834 while the third tube 2827 is connected to the distal element 2807 at point 2815.
According to the invention, sliding movement of the third tube 2827 relative to the fourth tube 2816 induces and aids in the expansion and contraction of the distal element 2807.
It should be appreciated that, in alternate embodiments, the first actuator, knob, slider or button 2814 is coupled to the fourth tube 2816 so that a sliding movement of the fourth tube 2827 (using the first actuator, knob, slider or button 2814) relative to the third tube 2827 induces and aids in the expansion and contraction of the distal element 2807. In other words, the first actuator, knob, slider or button 2814 can be coupled to either the third tube 2827 or the fourth tube 2816 in order to impart a sliding movement of the third and fourth tubes 2827, 2816 relative to each other.
Sliding the first knob 2814 within the groove 2812 towards the tip portion 2804 causes the third tube 2827 to telescope into the fourth tube 2816 thereby inducing an axial compression of the third tube 2827 relative to the fourth tube 2816 and consequently of the distal element 2807 between the proximal and distal ends 2856, 2858 of the wire mesh 2813. This causes the wire mesh 2813 (and therefore the distal element 2807) to expand radially around the lumen of the fourth tube 2816 and assume an expanded chalice, cup/concave shape having a diameter greater than a diameter in an unexpanded state. This kind of mechanical expansion of the distal element 2807 is preferred as this expansion provides a user control over the diameter of the distal element 2807 in an expanded state and, also provides a rigid structure that is less susceptible to collapse when placed under pressure.
Providing a physician control over the expansion size means that a physician can set one of a plurality of different expansion sizes and, upon setting that expansion size, the proximal or distal element maintains that expansion size even upon application of an external force in the ranges disclosed herein, such as 9.0 newtons to 15.0 newtons.
In some embodiments, a proximal element 2806 and/or distal element 2807 (first expansion member and/or second expansion member) expands upon moving the at least one actuation mechanism (slider, knob, lever, etc.) distally and wherein said expansion causes at least one of the first expandable member and the second expandable member to transform from a substantially linear configuration to a first shape, second shape or third shape depending on how far the at least one actuation mechanism has been moved distally.
The first shape, second shape or third shape is at least one of a spherical shape, an elliptical shape, a conical shape, a polygonal shape, a cylindrical shape, a shape of a stent, a shape of a chalice cup, a shape of an umbrella, a concave shape, a convex shape, a half-sphere shape, a windsock shape, a dumbbell shape, a star shape, or any combination of said shapes.
The first shape has a first outer surface and a furthest distance from the first outer surface to the elongated member is defined by a first distance; the second shape has a second outer surface and a furthest distance from the second outer surface to the elongated member is defined by a second distance; the third shape has a third outer surface and a furthest distance from the third outer surface to the elongated member is defined by a third distance and the third distance is greater than the second distance and wherein the second distance is greater than the first distance.
The first shape is configured to maintain said first distance even upon an application of an external force to the first outer surface in a range of 9.0 newtons to 15.0 newtons, wherein the second shape is configured to maintain said second distance even upon an application of an external force to the second outer surface in a range of 9.0 newtons to 15.0 newtons, and wherein the third shape is configured to maintain said third distance even upon an application of an external force to the third outer surface in a range of 9.0 newtons to 15.0 newtons.
Similarly, sliding the first knob 2814 within the groove 2812 away from the tip portion 2804 causes the third tube 2827 to telescope and expand out of the fourth tube 2816 thereby inducing an axial decompression of the distal element 2807 between the proximal and distal ends 2856, 2858 of the wire mesh 2813. This causes the wire mesh 2813 (and therefore the distal element 2807) to contract radially around the lumen of the fourth tube 2816 and assume an unexpanded substantially cylindrical shape having a diameter lesser than a diameter in an expanded state.
In some embodiments, the distal element 2807 assumes a substantially cylindrical shape when in a fully collapsed or unexpanded state, a substantially elliptical shape when in a partially expanded state and a concave, umbrella, half-sphere, sphere, windsock, dumbbell, star, polygon, chalice or cup-like shape when in a fully expanded state.
In some embodiments, the first knob 2814 locks (cannot be moved further forward) in a position in the groove 2812 when the distal element 2807 has expanded to a maximum diameter, which in an embodiment is approximately 25.0 mm. Thus, sliding the first knob 2814 forward enables the user to expand the distal element 2807 to a plurality of intermediate diameters and up to a maximum permissible diameter.
In some embodiments, the first knob 2814 is provided with a “clutch” feature so that, when opposing pressure is experienced from walls of a blood vessel during expansion of the distal element 2807, the “clutch” clicks in so that the user does not over expand. This feature is advantageous since it prevents the user from damaging the blood vessel due to over expansion of the distal element 2807.
In various embodiments, the distal element 2807 can expand to a diameter depending upon an application/functional use of the device 2800. By way of example, for use in treatment of pulmonary/large vessel having a diameter of up to 20.0 mm, the diameter of an expanded distal element 2807 ranges from 10.0 mm to 25.0 mm; for use in treatment of peripheral or deep vein thrombosis vessel having a diameter ranging from 5.0 mm to 10.0 mm, the diameter of an expanded distal element 2807 ranges from 3.0 mm to 12.0 mm; for use in treatment of neuro vessels, the diameter of an expanded distal element 2807 ranges from 2.0 mm to 10.0 mm; for use in retrieval of an occlusion in the inferior vena cava (IVC) vessels, the diameter of an expanded distal element 2807 ranges from 35.0 mm to 40.0 mm.
In some embodiments, for use in treatment of pulmonary embolism, each of the proximal and distal elements 2806, 2807 has an outer diameter ranging from 3.0 mm to 16.0 mm.
In some embodiments, for use in treatment of pulmonary embolism, each of the proximal and distal elements has a maximum outer diameter of 16.0 mm.
In some embodiments, for use in treatment of pulmonary embolism, the delivery catheter is of 9 Fr.
In some embodiments, for use in treatment of deep vein thrombosis, each of the proximal and distal elements 2806, 2807 has an outer diameter ranging from 3.0 mm to 20.0 mm.
In some embodiments, for use in treatment of deep vein thrombosis, the proximal element 2806 has a maximum outer diameter of 16.0 mm and the distal element 2807 has a maximum outer diameter of 20.0 mm.
In at least one embodiment, for application of the retrieval device 2800 in treatment of pulmonary embolism the proximal element 2806 is designed with a larger diameter as compared to the distal element 2807.
In at least one embodiment, if a diameter of the distal element 2807 is 16.0 mm, diameter of the proximal element 2806 is 20.0 mm, as the internal diameter of a patient's blood vessels tapers down distally.
In at least one embodiment, if a diameter of the distal element 2807 is 5.0 mm, then a diameter of the proximal element 2806 is 20.0 mm.
In at least one embodiment, for application of the retrieval device 2800 in treatment of deep vein thrombosis the proximal element 2806 is designed with a smaller diameter as compared to the distal element 2807.
In at least one embodiment, if a diameter of the distal element 2807 is 16.0 mm, then a diameter of the proximal element 2806 is 14.0 mm, as in this case, the internal diameter of a patient's blood vessels is larger proximally.
In at least one embodiment, if a diameter of the distal element 2807 is 16.0 mm then a diameter of the proximal element 2806 is 8.0 mm.
In various embodiments, in fully expanded state, each of the proximal and distal elements 2806, 2807 has a diameter ranging from 5.0 mm to 30.0 mm, preferably 10.0 mm to 25.0 mm, and more preferably 10.0 mm to 20.0 mm.
In some embodiments, the groove 2812 contains a series of interlocking features along its length such that the first knob 2814 can be selectively engaged or disengaged from a locked position in the handle 2802 at a plurality of expanded diameters for the distal element 2807.
Additionally, the handle portion 2802 includes a second actuator, knob, slider or button 2818 configured to enable the user to mechanically expand or contract the proximal element 2806.
Additionally, the handle portion 2802 includes a third actuator, knob, slider or button 2820 configured to enable the user to mechanically slide the proximal element 2806 forward towards the distal element 2807 or backwards away from the distal element 2807 that remains stationary.
Alternatively, the third actuator, knob, slider or button 2820 is configured to enable the user to mechanically slide the distal element 2807 back towards the proximal element 2806 or forwards away from the proximal element 2806 that remains stationary. The second and third knobs 2818, 2820 are slidably fitted into the groove 2812.
In some embodiments, the second slider 2818 is coupled with the first tube 2830 to enable the user to mechanically expand or contract the proximal element 2806. Alternatively, the second slider 2818 can be coupled with the second tube 2825 to enable the user to mechanically expand or contract the proximal element 2806.
In some embodiments, the third slider 2820 is coupled with the first and second tubes 2830, 2825 such that a sliding movement of the third slider 2820 towards or away from the tip portion 2804 causes the proximal element 2806 to slide towards or away from the distal element 2807 (while the third and fourth tubes 2827, 2816 remain stationary).
In some embodiments, sliding movement of the third slider 2820 towards or away from the tip portion 2804 causes the proximal element 2806 to slide towards or away from the distal element 2807 and, as discussed below, rotate (while the third and fourth tubes 2827, 2816 remain stationary).
In alternative embodiments, the third slider 2820 is coupled with the third and fourth tubes 2827, 2816 such that a sliding movement of the third slider 2820 towards or away from the tip portion 2804 causes the distal element 2807 to slide away from or towards the proximal element 2806 (while the first and second tubes 2830, 2825 remain stationary).
In some embodiments, the first tube 2830 is connected to the proximal element 2806 at the point 2829 while the second tube 2825 is connected to the proximal element 2806 at the point 2828. A sliding movement of the first tube 2830 relative to the second tube 2825 aids in the expansion and contraction of the proximal element 2806.
Upon axial compression of the first tube 2830 relative to the second tube 2825, the wire mesh 2826 is induced to expand radially around the lumen of the second tube 2825.
In some embodiments, when the second slider 2818 is moved or slides in the groove 2812 towards the tip portion 2804, this causes the first tube 2830 to telescope into the second tube 2825, thereby inducing an axial compression of the first tube 2830 relative to the second tube 2825. Consequently, the proximal element 2806 is caused to expand to a desired diameter.
When the second slider 2818 is moved away from the tip portion 2804 the first tube 2830 is caused to telescope out of the second tube 2825 thereby inducing an axial decompression (or elongation) of the first tube 2830 relative to the second tube 2825 between the proximal and distal ends 2829, 2828 of the wire mesh 2826. This causes the wire mesh 2826 (and therefore the proximal element 2806) to contract radially around the lumen of the second tube 2825 and assume an unexpanded shape having a diameter lesser than a diameter in an expanded state or assume a fully unexpanded state.
In some embodiments, when the third slider 2820 is moved in the groove 2812 towards the tip portion 2804, the proximal element 2806 is caused to slide distally away from the handle 2802 and towards the distal element 2807, whereas when the third knob 2820 is moved away from the tip portion 2804 the proximal element 2806 is caused to slide proximally towards the handle portion 2802 and away from the distal element 2807.
In at least one embodiment, a diameter of a fully expanded proximal element 2806 is approximately 18.0 mm. In various embodiments, the proximal element 2806 can expand to a diameter depending upon an application/functional use of the device 2800. By way of example, for use in treatment of a pulmonary/large vessel having a diameter of up to 20.0 mm, the diameter of an expanded proximal element 2806 ranges from 10.0 mm to 25.0 mm; for use in treatment of a peripheral/DVT vessel having a diameter ranging from 5.0 mm to 10.0 mm, the diameter of an expanded proximal element 2806 ranges from 3.0 mm to 12.0 mm; for use in treatment of neuro vessels, the diameter of an expanded proximal element 2806 ranges from 2.0 mm to 10.0 mm; for use in retrieval of an occlusion in the inferior vena cava (IVC) vessels, the diameter of an expanded proximal element 2806 ranges from 35.0 mm to 40.0 mm.
In some embodiments, the second slider 2818 locks (and thus, cannot be moved further forward) in a position in the groove 2812 when the proximal element 2806 has expanded to a maximum diameter. Thus, sliding the second slider 2818 forward enables the user to expand the proximal element 2806 to a plurality of intermediate diameters and up to a maximum permissible diameter.
In some embodiments, the second slider 2818 is provided with a “clutch” feature so that, when opposing pressure is experienced from walls of a blood vessel during expansion of the proximal element 2806, the “clutch” clicks in so that the user does not over expand. This feature is advantageous since it prevents the user from damaging the blood vessel due to over expansion of the proximal element 2806.
In various embodiments, the third slider 2820 can be configured to move synchronously along with the second slider 2818 toward the tip portion 2804 and/or in an opposing direction away from the tip portion 2804 for dislodging an occlusion and placing it in the distal element 2807.
In some embodiments, the groove 2812 has a series of interlocking features along its length such that the second slider 2818 can be selectively engaged or disengaged from a locked position in the handle 2802 at a plurality of expanded diameters for the proximal element 2806.
In some embodiments, the device 2800 utilizes a lead-screw mechanism for continuous adjustment of the diameters of the proximal and distal elements 2806, 2807, so that the corresponding second slider 2818 and first slider 2814 can be advanced or retracted to an infinitely variable number of positions in the groove 2812 and can be held in a desired position by using a friction based locking mechanism, in order for the proximal and distal elements 2806, 2807 to attain a desired diameter.
In some embodiments, a non-backdriving thread pattern in the lead-screw is used to provide a friction-brake when not actuated by the user, enabling continuous adjustment of the diameters of expanded proximal and distal elements 2806, 2807.
In embodiments, the fourth tube 2816 and the third tube 2827 are telescoped together to cause the distal element 2807 to expand or contract, and the second tube 2825 and the first tube 2830 are telescoped together, to cause the proximal element 2806 to expand or contract.
In at least one embodiment, by moving the third slider 2820, leading to advancing or retracting of the second tube 2825 and the first tube 2830 together as one, the relative positions of the proximal element 2806 and the distal element 2807 can be adjusted in an expanded or collapsed state.
In an alternate embodiment, by moving the third slider 2820 which leads to advancing or retracting of the third tube 2827 and the fourth tube 2816 together as one, the relative positions of the proximal element 2806 and the distal element 2807 can be adjusted in an expanded or collapsed state.
In at least one embodiment, a distance between the proximal element 2806 and the distal element 2807 ranges between 2.0 mm to 60.0 mm. Stated differently, the third knob 2820 can be actuated to cause the proximal element 2806 to move distally towards the distal element 2807 until a minimum distance between the proximal and distal elements 2806, 2807 is 2.0 mm. Similarly, the third slider can be actuated to cause the proximal element 2806 to move proximally and away from the distal element 2807 until a maximum distance between the proximal and distal elements 2806, 2807 is 60.0 mm.
In some embodiments, the second slider 2818 can be positioned at several different locations/positions along the length of the groove 2812, wherein each of the locations/positions corresponds to a different degree of expansion of the proximal element 2806, and hence a different shape of the proximal element 2806.
In some embodiments, a minimum distance between the proximal and distal elements 2806, 2807 ranges from 0.0 mm to 5.0 mm and a maximum distance between the proximal and distal elements 2806, 2807 ranges from 60.0 mm to 400.0 mm.
In some embodiments, the first tube 2830 extends from the handle portion 2802 to the proximal element 2806 and is co-axial with the second tube 2825, while the third tube 2827 extends from the handle portion 2802 to the distal element 2807 and is co-axial with the fourth tube 2816 which is fixedly attached to the anchor nose 2834. In some embodiments, the second tube 2825 and the fourth tube 2816 provide a fixed distal position of the corresponding wire mesh (proximal or distal elements 2806, 2807 respectively) against which the telescoping first tube 2830 and the third tube 2827 actuate to expand the proximal or distal elements 2806, 2807, respectively. The anchor nose 2834 provides a termination and fixation point for the distal element 2807 and, in an embodiment, performs a secondary function of a radiopaque marker.
In various embodiments, diameters of the telescoping tubes 2830, 2825, 2827 and 2816 range from 0.010 mm to 1.0 mm for neurovascular and peripheral applications, and 1.0 mm to 3.0 mm for pulmonary and larger applications.
In some embodiments, the fourth tube 2816 can be a solid wire instead of a hollow tube.
In at least one embodiment, a fully expanded distal element 2807 can be concave in shape or can be shaped like a chalice, cup, or a half-sphere as shown in
Referring back to
Thus, in various embodiments, the proximal and distal elements 2806, 2807 expand to a particular diameter and a particular radial force, thereby allowing trapping and curettage of thrombus or clot material from a vessel lumen and wall.
In some embodiments, the retrieval device 2800 utilizes its adjustable radial forces and its adjustable size to actively curettage the wall of an artery or vein. In some embodiments, the retrieval device 2800 enables removal of thrombus by simultaneously capturing, compressing, dragging and curetting thrombotic material from vessel walls.
In at least one embodiment, the proximal element is configured to capture, and/or contain, a size of clot or thrombus material in a volume range of 1.0 mm to 100.0 cm.
In some embodiments, the handle portion 2802 includes a plurality of gradations such as, for example and by way of example only, three gradations of low, medium and high, five gradations ranging from low to high or eight gradations ranging from low to high. Each gradation is indicative of a corresponding predefined diameter of the proximal and distal elements in expanded states. The three slide buttons 2814, 2818, 2820 can be actuated to any one of the plurality of gradations and then détente to that position.
While, in some embodiments, the handle portion 2802 includes three buttons 2814, 2818, 2820 to manipulate the proximal and distal elements 2806, 2807, in alternate embodiments fewer than three buttons can be used. By way example, in some embodiments, a clinician's use of the device 2800 is monitored over a predefined number of uses or operations of the device 2800 while performing mechanical thrombectomy procedures. Based on the monitoring, a preferred sequence of deployment of the proximal and distal elements 2806, 2807 is determined and data indicative of the deployment sequence is stored in memory of computing/programming means (residing within the handle portion 2802 or remote from the handle portion 2802).
As a non-limiting illustration, the deployment sequence can include (after placing the device 2800 proximate an occlusion) expanding the distal element first followed by expanding the proximal element. Consequently, a first button (when actuated) is programmed to carry out the deployment sequence and a second button is then used to reciprocate the proximal element axially. Thus, in this illustration, only two buttons are required to manipulate the proximal and distal elements 2806, 2807.
In another case scenario, the deployment sequence can include expanding the distal element, expanding the proximal element and then moving the proximal element axially fore and aft for a cycle of 5 reciprocations. Consequently, a first button (when actuated) is programmed to carry out the deployment sequence.
Of course, in some embodiments, the second and third buttons can still be used manually after the deployment sequence has been completed by the programmed button. In some embodiments, computing/programming means executing an Artificial Intelligence (AI) algorithm implements the deployment sequence, once the retrieval device 2800 is placed in vivo, to automatically expand the proximal and distal elements and/or move the proximal element axially.
It should also be appreciated that the three buttons 2814, 2818, 2820 can be sliders, knobs, levers, dials, push buttons or a combination thereof. For example, first and second knobs can be used to expand/contract the proximal and distal elements respectively while a push button can be used to move the proximal element axially.
In another example, first, second and third levers can be actuated to generate pump actions to expand/contract the proximal and distal elements and to move the proximal element axially.
In yet another example, first and second dials can be actuated clockwise—counterclockwise to expand/contract the proximal and distal elements respectively while a slider button can be used to move the proximal element axially.
Push buttons can use servos and ball screws to expand/contract the proximal and distal elements and to move the proximal element axially. Knobs can be circumferentially designed on the handle portion 2802.
In some embodiments, the distal and/or proximal elements 2807, 2806 are self-expanding Nitinol® wire meshes.
In some embodiments, the self-expanding distal and/or proximal elements 2807, 2806 are restrained by the handle portion 2802.
In some embodiments, the self-expanding distal and/or proximal elements 2807, 2806 are constrained by a sheath or ring that covers the tip portion 2804. The self-expanding distal and/or proximal elements 2807, 2806 expand when the constraining sheath or ring is removed.
Thus, in some embodiments, the self-expanding distal and/or proximal elements 2807, 2806 are configured for expansion based on removal of a constraining or resisting member.
In some embodiments, the retrieval device 2800, within the catheter 2835, has a hypo tube and a central wire is positioned within the hypo tube. The distal element 2807 is positioned on the wire while the proximal element 2806 is positioned on the hypo tube at a fixed location.
Once the device 2800 is in place, the central wire is passed out of the catheter 2835 and the distal element 2807 becomes unconstrained and automatically pops open to a preset size or outer diameter (self-expanding).
With the central wire and distal element 2807 in place, the hypo tube is then moved axially. Because the hypo tube is over the wire, moving the hypo tube automatically moves the proximal element 2806 relative to the distal element 2807. The hypo tube is moved until the proximal element 2806 also pops open. The physician then moves the hypo tube relative to the wire (which is fixed in place) to move the proximal element 2806 relative to the distal element 2807 and scrub out the clot/occlusion.
Referring to
In at least one embodiment, the first tube 2830 is concentrically positioned around the second tube 2825, the second tube 2825 is concentrically positioned around the third tube 2827, and the third tube 2827 is concentrically positioned around the fourth tube 2816.
As depicted in
As also depicted in
As further depicted in
A fifth hub 2810k is stationary to the handle 2802, and, in some embodiments, is bonded to a PEEK (Polyether ether ketone) tube that goes around all the first, second, third and fourth tubes 2830, 2825, 2827, 2816 and extends a predefined length distally from a proximal end 2830k of the handle 2802 in order to provide kink resistance or act as a strain relief to prevent kinks and add stiffness at proximal ends of the tubes 2830, 2825, 2827, 2816 as the exit the proximal end 2830k of the handle 2802.
In at least one embodiment, the first slider 2814 is coupled to the fourth tube 2816 such that a sliding movement of the first slider 2814 (along a length of the handle 2802) causes the fourth tube 2816 to move axially while the first, second and third tubes 2830, 2825, 2827 remain stationary thereby causing the distal element 2807 to expand or contract.
In some embodiments, sliding the first slider 2814 distally (towards the tip portion 2804) causes the fourth tube 2816 and therefore the distal end 2858 of the distal element 2807 to move proximally causing the distal element 2807 to expand whereas sliding the first slider 2814 proximally (away from the tip portion 2804) causes the fourth tube 2816 and therefore the distal end 2858 of the distal element 2807 to move distally causing the distal element 2807 to compress or contract. Thus, the movement of the first slider 2814 causes the fourth tube 2816 to move relative to the third tube 2827.
In alternate embodiments, however, the first slider 2814 can be configured to move the third tube 2827 relative to the fourth tube 2816.
According to the invention, the second slider 2818 is coupled to the first tube 2830 such that a sliding movement of the second slider 2818 (along the length of the handle 2802) causes the first tube 2830 to move axially while the second, third and fourth tubes 2825, 2827, 2816 remain stationary thereby causing the proximal element 2806 to expand or contract.
In some embodiments, sliding the second slider 2818 distally (towards the tip portion 2804) causes the first tube 2830 and therefore the proximal end 2860 of the proximal element 2806 to move distally thereby causing the proximal element 2806 to expand whereas sliding the second slider 2818 proximally (away from the tip portion 2804) causes the first tube 2830 and therefore the proximal end 2860 of the proximal element 2806 to move proximally thereby causing the proximal element 2806 to compress or contract. Thus, the movement of the second slider 2818 causes the first tube 2830 to move relative to the second tube 2825.
In alternate embodiments, however, the second slider 2818 can be configured to move the second tube 2825 relative to the first tube 2830.
According to the invention, the third slider 2820 is coupled to the first and second tubes 2830, 2825, whereby sliding movement of the third slider 2820 (along the length of the handle 2802) causes the first and second tubes 2830, 2825 to move in unison while the third and fourth tubes 2827, 2816 remain stationary, resulting in the axial movement of the proximal element 2806 relative to the distal element 2807 without affecting expansion/contraction of the proximal element 2806.
In some embodiments, sliding the third slider 2820 distally (towards the tip portion 2804) thus causes the proximal element 2806 to move towards the distal element 2807 whereas sliding the third slider 2820 proximally (away from the tip portion 2804) causes the proximal element 2806 to move away from the distal element 2807.
According to the invention, the third slider 2820 can also be coupled to the third and fourth tube 2827, 2816, whereby sliding movement of the third slider 2820 (along the length of the handle 2802) causes the third and fourth tube 2827, 2816 to move in unison while the first and second tubes 2830, 2825 remain stationary, resulting in axial movement of the distal element 2807 relative to the proximal element 2806 without affecting expansion/contraction of the distal element 2807.
In some embodiments, sliding the third slider 2820 distally (towards the tip portion 2804) thus causes the distal element 2807 to move away from the proximal element 2806 whereas sliding the third slider 2820 proximally (away from the tip portion 2804) causes the distal element 2807 to move towards the proximal element 2806.
In some embodiments, by default, a spring-loaded locking mechanism 2820k keeps the first and second hubs 2802k, 2804k coupled to carriage 2815k.
In some embodiments, the three sliders 2814, 2818, 2820 and the locking mechanism 2820k utilize springs to stay locked in place with teeth on a rail and must be pressed/depressed to release or unlock.
According to the invention, depressing the second slider 2818 causes the locking mechanism 2820k to decouple the first and second tubes 2830, 2825 from the carriage 2815k and engage the second slider 2818 with the first tube 2830. Consequently, the sliding movement of the second slider 2818 causes the first tube 2830 to move axially thereby expanding or contracting the proximal element 2806.
Once released, the locking mechanism 2820k is actuated again and, therefore, the third slider 2820 can be used to move both first and second tubes 2830, 2825 and therefore the entire proximal element 2806.
Thus, the second slider 2818 expands or contracts the proximal element 2806 by moving the first tube 2830 while the second tube 2825 remains stationary.
In a preferred embodiment, the second slider 2818 is configured to open or expand the proximal element 2806 incrementally and mechanically to one of a plurality of predefined geometric shapes, dimensions, sizes, diameters or volumes, each of which (other than the linear shape) is capable of withstanding a same or different applied pressure in the range of approximately 0.0 newtons to 25.0 newtons.
In some embodiments, the plurality of geometric shapes includes at least two of linear, ellipsoid, spheroid, spherical or disk shape.
In some embodiments, the second slider 2818 includes a plurality of teeth on a rail that allows the proximal element 2806 to be opened or expanded incrementally.
As discussed earlier, the second slider 2818 is spring loaded, such that it needs to be depressed in order to move or slide the second slider 2818 to have a desired geometric shape, dimension, size, diameter or volume of the proximal element 2806. In other words, the dimensional increments are built in and represented, in some embodiments, by corresponding iconography on the handle 2802 to visually represent the plurality of predefined geometric shapes, dimensions, sizes, diameters or volumes of the proximal element 2806.
Additionally, since a procedure using the retrieval device 2800, to remove an occlusion or unwanted material from a vessel lumen, is typically carried out under fluoroscopy, the physician can see the internal diameter of the vessel lumen, feel the tactile feedback (generated due to the second slider 2818 having the plurality of teeth on the rail that allows the proximal element 2806 to be opened or expanded incrementally) versus the outer diameter of the expanded proximal element 2806 and have a visual reference.
In at least one embodiment, the fourth tube 2816 is configured to move in a direction opposite to a direction of movement of the first tube 2830. In the absence of the opposing movement of the first and second tubes 2830, 2816, if the first slider 2814 is moved distally the fourth tube 2816 will also move distally causing the distal element 2807 to contract while if the first slider 2814 is moved proximally then the fourth tube 2816 will also move proximally causing the distal element 2807 to expand.
This movement of the first slider 2814 and the fourth tube 2816, however, is less intuitive to the user (since movement of the second slider 2818 distally causes the proximal element 2806 to expand and vice versa). Therefore, a gear 2825k reverses the direction of movement of the first slider 2814 in a 1:1 relation to the fourth hub 2808k and therefore the fourth tube 2816.
Consequently, movement of the first slider 2814 distally causes the fourth tube 2816 to move proximally causing the distal element 2807 to expand while movement of the first slider 2814 proximally causes the fourth tube 2816 to move distally causing the distal element 2807 to contract.
Thus, the first slider 2814 expands or contracts the distal element 2807 by moving the fourth tube 2816 while the first, second and third tubes 2830, 2825, 2827 remain stationary. The first slider 2814 is configured to open or expand the distal element 2807 incrementally and mechanically to one of a plurality of predefined geometric shapes, dimensions, sizes, diameters or volumes, each of which (other than the linear shape) is capable of withstanding a same or different applied pressure in the range of approximately 0.0 newtons to 25.0 newtons.
In some embodiments, the first slider 2814 includes a plurality of teeth on a rail that allows the distal element 2807 to be opened or expanded incrementally.
In some embodiments, the first slider 2814 is spring loaded, such that it needs to be depressed to move or slide the first slider 2814 to have a desired geometric shape, dimension, size, diameter or volume of the distal element 2807. In other words, the dimensional increments are built in and represented, in some embodiments, by corresponding iconography on the handle 2802 to visually represent the plurality of predefined geometric shapes, dimensions, sizes, diameters or volumes of the distal element 2807.
Additionally, since a procedure using the retrieval device 2800, to remove an occlusion or unwanted material from a vessel lumen, is typically carried out under fluoroscopy, the physician can see the internal diameter of the vessel lumen, feel the tactile feedback (generated due to the first slider 2814 having the plurality of teeth that allows the distal element 2807 to be opened or expanded incrementally) versus the outer diameter of the expanded distal element 2807 and have a visual reference.
In some embodiments, the retrieval device 2800, alternatively and/or in addition to the aforementioned tactile and visible feedback means for controlling the physical parameters of the proximal and distal elements 2806, 2807, comprises a sensor system that is adapted to monitor the applied pressure (or force) exerted on a wall of a lumen, such as a vessel wall, by the proximal and distal elements 2806, 2807 (when expanded by the first and second sliders 2814, 2818) to prevent overexpansion of the proximal and distal elements 2806, 2807 and damage to the vessel.
In some embodiments, the sensor system comprises (i) a first sensor assembly comprising a first micro-fabricated or micro-miniature (MEMS) pressure sensor that is disposed proximate the outer periphery of the proximal element 2806 and adapted to directly monitor the pressure exerted on the wall of a vessel when the proximal element 2806 expands and is in contact with the vessel wall, and a first associated application-specific integrated circuit (ASIC), which is adapted to at least generate and transmit signals representing the pressure exerted on the wall of the vessel by the proximal element 2806, and (ii) a second sensor assembly comprising a second MEMS pressure sensor that is disposed proximate the outer periphery of the distal element 2807 and similarly adapted to directly monitor the pressure exerted on the wall of a vessel when the distal element 2807 expands and is in contact with the vessel wall, and a second associated ASIC, which is similarly adapted to at least generate and transmit signals representing the pressure exerted on the wall of the vessel by the distal element 2807.
Suitable MEMS sensors are disclosed in PCT Publication Nos. WO2011/081669A1 and WO2022266465A1, U.S. Pat. Nos. 7,398,688 and 8,641,633, and U.S. Pub. No. 20190133462.
In some embodiments, the first and second ASICs are adapted to wirelessly transmit the generated pressure signals to a sensor module disposed in the device handle 2802.
In some embodiments, the sensor module is adapted to receive the pressure signals and, as a function thereof, provide a predetermined mechanical cue, i.e., tactile response, such as a vibration, and/or an audio signal, i.e., tactile and audio feedback of vessel wall pressure.
In some embodiments, the first and second ASICs are adapted to wirelessly transmit the generated pressure signals to an external imaging system, such as employed during an angioplasty procedure.
In some embodiments, the external imaging system is adapted to display the pressure(s) represented by the pressure signals and/or a series or warning lights in response to the pressure signals, e.g., a green light indicating a first “safe” vessel pressure, a yellow warning light indicating a “threshold” vessel pressure and a red warning light indicating an “unsafe” vessel pressure, i.e., visual feedback of vessel wall pressure.
As indicated above, the proximal and distal elements 2806, 2807 are adapted to radially expand and contract.
As also indicated above, the proximal element 2806 is also adapted to axially move relative to the distal element 2807.
In some embodiments, the proximal and/or distal element 2806, 2807 is further adapted to rotate.
According to the invention, the elements 2806, 2807 can be rotated by various conventional means.
In some embodiments, the elements 2806, 2807 comprise motorized units.
In such embodiments, a small motor positioned in or proximate the handle is coupled to each of the proximal and/or distal elements 2806, 2807 and, upon actuation, the motor causes one of or both the proximal and/or distal elements 2806, 2807 to rotate.
As discussed in detail below, in a preferred embodiment, one of or both of the proximal and/or distal elements 2806, 2807 can be rotated via movement of at least one of the first, second and third physically manipulable interfaces such as, for example sliders 2814, 2818 and 2820.
Referring now to
As further depicted in
As also depicted in
According to the invention, sliding movement of the third slider 2820 similarly causes the first and second tubes 2830, 2825 to move in unison axially while the third and fourth tubes 2827, 2816 remain stationary, resulting in the axial movement of the proximal element 2806 relative to the distal element 2807 without affecting the expansion or contraction of the proximal element 2806.
In this embodiment, however, sliding movement of the third slider 2820 also causes the worm gear 2825l to cooperate with the teeth on the carriage 2815k, whereby the worm gear 2825l rotates, which, by virtue of the positioning of the second tube pin 2825p in the first tube slot 2830s, causes the first and second tubes 2830, 2825 and, hence, proximal element 2806 to also rotate.
According to the invention, various degrees of rotation of proximal element 2806 per axial movement of the carriage 2815k can be provided by selecting one of a multitude of available worm gear pitches.
Referring now to
As depicted in
As depicted in
Referring back to
As depicted in
As also depicted in
According to the invention, when the carriage locking mechanism 2815lm is actuated and, hence, the locking pin 2815p is positioned in the pin seats of the bottom and top elongated members 2815m, 2815l, sliding movement of the third slider 2820 similarly causes the first and second tubes 2830, 2825 to move in unison causing axial movement of the proximal element 2806. The axial movement of the second tube 2825 also causes rotation of the worm gear 2825l, which is induced by the teeth 2815t on the top elongated member 2815l, and, thereby, rotation of the proximal element 2806.
When the carriage locking mechanism 2815lm is de-actuated, wherein the locking pin 2815p is at least withdrawn out of the pin seat of the top elongated member 2815l, sliding movement of the fourth slider 2822 causes axial movement of the top elongated member 2815l, whereby, the teeth 2815t on the top elongated member 2815l similarly induce rotation of the worm gear 2825l, and, thereby, rotation of the proximal element 2806.
The noted arrangement thus allows an operator of the retrieval device to rotate the proximal element 2806 at a desired position in a vessel exhibiting an occlusion to further facilitate dislodging the occlusion from the vessel wall.
As shown in a first view 2805m of
As depicted in a second view 2810m of
In some embodiments, as shown in a third view 2815m of
It should be appreciated that the keyhole is preferably uniquely designed such that handles can have one of a plurality of differently sized, shaped, or configured keyholes and therefore require a similarly and complementarily designed key to successfully pass through the keyhole and push out the pin.
Referring now to
In accordance with some embodiments of the invention, the method 4300 enables removing the occlusion from a lumen having an internal diameter ranging from 1.0 mm to 14.0 mm.
In some embodiments, the method 4300 enables removing the occlusion from a lumen having an internal diameter less than 3.0 mm, and even those less than 1.0 mm, wherein the lumen is one of, but not limited to, biliary ducts, fistula de-clotting, brain blood vessels, upper and lower extremities, ureter, appendicular artery and peripheral arterial vessels (particularly in the hands, arms, forearms, thighs, legs and feet).
For the method 4300, a retrieval device of the present invention, such as, for example, the device 2800, is configured or adapted for performing thrombectomy procedures in biliary ducts, fistula de-clotting, hepatic bile ducts, brain blood vessels, upper and lower extremities, ureter, appendicular artery and peripheral arterial vessels (particularly in the hands, arms, forearms, thighs, legs and feet) in order to treat peripheral arterial disease (PAD) and thromboembolic processes related to all arterial and hematologic pathologies.
In such embodiments of the retrieval device, the handle 2802 is coupled to a proximal end of the elongated member 2805 through at least one telescoping tube, wherein a distal end of the elongated member 2805 has the tip portion 2804 mounted with proximal and distal elements 2806, 2807.
In some embodiments, the handle 2802 can include a physically manipulable interface such as, for example, a knob, slider or button that is used to expand/open and contract/close both the proximal and distal elements 2806, 2807 simultaneously.
In some embodiments, a distance between the proximal and distal elements 2806, 2807 is predefined/fixed and ranges from 2.0 cm to 6.0 cm.
In some embodiments, the physically manipulable interface such as a slider has a plurality of teeth on a rail to enable the proximal and distal elements 2806, 2807 to expand or open incrementally to a plurality of shapes, dimensions, sizes, volumes or outer diameters.
In some embodiments, the proximal and distal elements 2806, 2807 can be expanded to shapes, dimensions, sizes, volumes or outer diameters corresponding to up to 20 increments.
In some embodiments, the proximal and distal elements 2806, 2807 can be expanded to shapes, dimensions, sizes, volumes or outer diameters on a continuous basis without set increments.
In some embodiments, each of the plurality of shapes, dimensions, sizes, volumes or outer diameters of the proximal and distal elements 2806, 2807 is capable of withstanding a same applied pressure in the range of 0.0 newtons to 25.0 newtons.
Alternatively, in some embodiments, each of the plurality of shapes, dimensions, sizes, volumes or outer diameters of the proximal and distal elements 2806, 2807 is capable of withstanding different applied pressure in the range of 0.0 newtons to 25.0 newtons.
The dimensional increments, for simultaneously expanding the proximal and distal elements 2806, 2807 are built in and represented, in some embodiments, by corresponding iconography on the handle 2802 to visually represent the plurality of predefined geometric shapes, dimensions, sizes, diameters or volumes of the proximal and distal elements 2806, 2807.
Additionally, since a procedure using the retrieval device, to remove an occlusion or unwanted material from a vessel lumen, is typically carried out under fluoroscopy, the physician can see the internal diameter of the vessel lumen, feel the tactile feedback (generated due to the slider having the plurality of teeth on the rail) versus the outer diameter of the expanded proximal and distal elements 2806, 2807 and have a visual reference.
In some embodiments, the retrieval device with simultaneously expandable and contractable/compressible proximal and distal element 2806, 2807 is configured to use a guidewire having a diameter of 0.014 in. or 0.018 in., an aspiration catheter 2835 of 7 to 8 Fr and having a length of 135.0 cm, and an elongated member 2805 of 5 Fr having a length of 145.0 cm.
In some embodiments, in a fully expanded state, a diameter of each of the proximal and distal elements ranges from 5.0 mm to 30.0 mm, preferably 10.0 mm to 25.0 mm, and more preferably 10.0 mm to 20.0 mm.
Optionally, in some embodiments, the handle 2802 can include another physically manipulable interface such as, for example, a knob, slider or button that is used to axially move the proximal and distal element 2806, 2807 together.
For use during the procedure, in some embodiments, a tip portion of the retrieval device (with proximal and distal elements that can be expanded and contracted simultaneously) is placed into a delivery catheter and thereafter the delivery catheter is inserted into the aspiration catheter, and follows through to a valve hub, so that at least the tip portion projects distally from a distal end of the aspiration catheter.
Referring now to
In some embodiments, the guidewire has a diameter of 0.014 in. or 0.018 in. At step 4304, the aspiration catheter is advanced over the guidewire such that a distal end of the aspiration catheter is positioned at or proximate the occlusion.
At step 4306, the delivery catheter is advanced through the aspiration catheter such that a distal end of the delivery catheter lies proximate the distal end of the aspiration catheter.
At step 4308, the retrieval device (with proximal and distal elements that can be expanded and contracted simultaneously) is positioned near the occlusion with the distal element mounted on the tip portion of the retrieval device is positioned within or all the way through and beyond the occlusion. In some embodiments, this ensures that the proximal and distal elements, in compressed or non-expanded state, are positioned within the occlusion.
At step 4310, the proximal and distal elements, positioned within the occlusion, are mechanically expanded, simultaneously, to desired diameters (and therefore, to corresponding shapes and to exert corresponding radial forces).
In some embodiments, a slider on a handle of the retrieval device is actuated to cause the wire mesh structures of the proximal and distal elements to expand out concurrently.
In some embodiments, upon expansion, the proximal and distal elements are configured to resist compression from an applied force in a range of 0.0 newtons to 25.0 newtons.
At step 4312, the proximal and distal elements are moved axially (in one or more fore and aft motions) to dislodge and scrape/curettage the occlusion.
In some embodiments, the occlusion can also be trapped into the mesh lattices of the proximal and distal elements.
In some embodiments, the handle is moved fore and aft to cause the tip portion and therefore the proximal and distal elements to be moved fore and aft to dislodge and curettage the occlusion.
In some embodiments, another slider provided on the handle is actuated to axially move the proximal and distal elements together relative to the tip portion.
In some embodiments, the proximal and distal elements are configured to be moved axially in a range from 1.0 mm to 8.0 cm and preferably at least 6.0 cm.
At step 4314, the dislodged and scraped occlusion is removed or aspirated by applying a negative pressure (or suction) through the aspiration catheter.
In some embodiments, the fore and aft movement of the proximal and distal elements further directs the dislodged and scraped occlusion towards the aspiration catheter.
At step 4316, the proximal and distal elements are collapsed or compressed simultaneously.
In some embodiments, the slider is actuated to cause the proximal and distal elements to collapse or compress.
Finally, at step 4318, the proximal and distal elements, in collapsed or compressed state, are retracted and removed from the lumen of the patient.
Referring now to
In some embodiments, the telescoping tubes 2906, 2908, 2910 and 2912 are capable of being retracted or expanded axially relative to each other, thereby decreasing or increasing, respectively, a distance between the distal element 2902 and the proximal element 2904. The retraction and expansion of the telescoping tubes 2906, 2908, 2910 and 2912 as well as the expansion and contraction of the distal and proximal elements 2902, 2904, in some embodiments, is carried out by means of a handle of the retrieval device 2900.
In some embodiments, an axial compression between respective proximal and distal ends of the of the distal and proximal elements 2902, 2904 causes the elements 2902, 2904 to expand radially about a longitudinal axis and obtain a diameter greater than a diameter in an unexpanded state.
As depicted in
As depicted in
In some embodiments, to remove an occlusion, the distal element 2902 is positioned within, or all the way through, the occlusion so that the distal element 2902 is held fixed in a position within or beyond a distal end of the occlusion while the proximal element 2904 precedes a proximal end of the occlusion. Subsequently, the proximal element 2904 is moved back and forth axially along a longitudinal axis to dislodge and trap the occlusion between the distal and proximal elements 2902, 2904. Thus, by maneuvering the handle, the distance between the distal and proximal elements 2902, 2904 can be increased/decreased to dislodge the occlusion and trap the occlusion between the distal and proximal elements 2902, 2904. This is described in detail in subsequent paragraphs with reference to
Referring again to
Referring now to
During operation of the device 3000, the tip portion 3004 is inserted into a body lumen for removing an occlusion while the handle portion 3002 remains in an operator/user's hands to maneuver the insertion of the tip portion 3004 in a desired position in the body lumen.
During insertion of the device 3000 into the body lumen, the distal end 3052 of the tip portion 3004 enters the body first and is placed within, beyond or in close proximity of the occlusion within a blood vessel of the body by using the handle 3002.
The tip portion 3004 comprises a distal element or body 3007, which in an embodiment, is a mechanically expandable, rigid anchor fixedly attached to the distal end 3052 of the tip portion 3004, and a proximal element or body 3006, which in an embodiment is a pusher ball that is slidably mounted on the proximal end 3050 of the tip portion 3004. The tip portion 3004 is at least partially covered with a sheath 3005 which can be retracted exposing at least the distal element 3007 and proximal element 3006 when the device 3000 is inserted and maneuvered within a vasculature of a person, by using the handle portion 3002.
According to the invention, in some embodiments, the distal element 3007 can take the form of a cylinder, stent, chalice cup, umbrella, concave structure, half-sphere, sphere, windsock, dumbbell, star, polygon, lever, or any other suitable shape configured for holding an occlusion and aiding retrieval of the occlusion.
In some embodiments, the tip portion 3004 comprises flexible elements or tubes 3008 that extend all the way back to the handle portion 3002 and can be maneuvered together to enable an operator/doctor to expand or contract or rotate the distal and proximal elements 3007, 3006 as well as slide the proximal element 3006 (towards or away from the distal element 3007) for removing the occlusion.
In at least one embodiment, the flexible elements 3008 comprise four flexible telescoping tubes as described earlier with reference to
Referring again to
The handle portion 3002 comprises a first knob 3010 configured to actuate the proximal element 3006, a second knob 3012 configured as a ‘press and hold’ button, a third knob 3014 configured to actuate the distal element 3007 and flexible elements 3008 which extend up to the tip portion 3004.
The flexible elements 3008 enable the proximal element 3006 and the distal element 3007 to move relative to each other for removal of the occlusion as is described with reference to
In some embodiments, the distal element 3007 is expanded to a plurality of intermediate diameters (and up to a maximum permissible diameter) by rotating the third knob 3014 in an anticlockwise direction. Rotating the third knob 3014 in a clockwise direction contracts the distal element 3007 back to the plurality of intermediate diameters and eventually to a non-expanded/collapsed state from the expanded state.
In some embodiments, the proximal element 3006 is expanded to a plurality of intermediate diameters (and up to a maximum permissible diameter) by rotating the first knob 3010 in an anticlockwise direction. Rotating the first knob 3010 in a clockwise direction contracts the proximal element 3006 back to the plurality of intermediate diameters and eventually to a non-expanded/collapsed state from the expanded state.
A distance between the proximal and distal elements 3006, 3007 can be decreased by pressing the second knob 3012 and moving the first knob 3010 towards the tip portion 3004. As the distance between the second knob 3012 and the first knob 3010 increases, the distance between the proximal and distal elements 3006, 3007 decreases.
A user can use the second knob 3012 along with the first knob 3010 to cause a relative movement between the proximal and distal elements 3006, 3007 for dislodging an occlusion, and causing the occlusion to be lodged between the proximal and distal elements 3006, 3007 for removal from a patient's body.
According to the invention, the proximal and distal elements 3006, 3007 can similarly comprise one of the aforementioned outer coatings, e.g., a biodegradable polymer composition comprising a pharmacological agent.
In some embodiments, a protective bag covers a tip portion of a retrieval device of the present specification. The protective bag can be removed from the tip portion and re-draped over the tip portion as needed.
As depicted in
A first tether 3310, such as a wire, is attached to an internal surface of the bag 3305 at its distal end 3314.
In some embodiments, the first tether 3310 extends from the distal end 3314 of the bag 3305 through the respective lumens of the four telescoping tubes and up to a handle (such as, the handle 2802 of
Second and third tethers 3312a, 3312b (which can also be wires) are attached to proximal ends 3313a, 3313b of the bag 3305. In some embodiments, the second and third tethers 3312a, 3312b extend from the proximal ends 3313a, 3313b of the bag 3305 to the handle of the retrieval device.
As depicted in
Referring now to
It should be appreciated that the bag 3305 in
Additionally, the bag in
In some embodiments, structurally, leading portions of the proximal and distal elements are different from trailing portions of the proximal and distal elements.
The proximal element 3406 has a leading portion 3406a and a trailing portion 3406b. Similarly, the distal element 3407 has a leading portion 3408a and a trailing portion 3408b.
In some embodiments, the leading portions 3406a, 3408a are solid (such as, for example, made of a biocompatible fabric) while the trailing portions 3406b, 3408b are wire meshes having a plurality of cells. This causes the leading portions 3406a, 3408a to be more rigid, stiff or firm compared to the trailing portions 3406b, 3408b. In some embodiments, the leading portions 3406a, 3408a as well as the trailing portions 3406b, 3408b are wire meshes.
However, the leading portions 3406a, 3408a have a plurality of cells of a first size while the trailing portions 3406b, 3408b have a plurality of cells of a second size. In some embodiments, the first size is smaller compared to the second size causing the leading portions 3406a, 3408a to be more rigid, stiff or firm compared to the trailing portions 3406b, 3408b.
In various embodiments, the leading and trailing portions can or cannot comprise substantially half of the respective proximal and distal elements. It should be appreciated that the more rigid, stiff or firm leading portions 3406a, 3408a enable the tip portion 3404 to be effectively slid through an occlusion, bareback.
A tether 3510, such as a wire, is coupled or attached to trailing or proximal ends 3506′, 3508′ of the respective proximal and distal elements 3506, 3508. The tether 3510 extends from the trailing or proximal ends 3506′, 3508′ all the way to a handle of the retrieval device.
While advancing the tip portion 3500, bareback, in a patient's body the tether 3510 is pulled proximally towards the handle and thereby kept taut. This prevents the proximal and distal elements 3506, 3508 from expanding inadvertently thereby holding them retracted and flat.
Referring now to
At step 3102a, a guidewire is advanced through the lumen of the patient and positioned through the occlusion.
At step 3104a, an aspiration catheter is advanced over the guidewire such that a distal end of the aspiration catheter is positioned at or proximate the occlusion.
At step 3106a, a delivery catheter is advanced through the aspiration catheter such that a distal end of the delivery catheter lies proximate the distal end of the aspiration catheter.
At step 3108a, a retrieval device is deployed through the delivery catheter so that a distal element mounted on a tip portion of the retrieval device is positioned within or all the way through and beyond the occlusion.
At step 3110a, the distal element is mechanically expanded to a desired diameter using a first slider on a handle of the retrieval device. In some embodiments, the distal element is a mechanically expandable and rigid anchor fixedly attached proximate a distal end of the tip portion.
At step 3112a, a proximal element (also mounted on the tip portion) is mechanically expanded to a desired diameter using a second slider on the handle of the retrieval device.
At step 3114a, the proximal element is moved axially (in one or more back and forth motions) along the tip portion to dislodge the occlusion (and curettage the vessel).
In some embodiments, the axial fore and aft movement of the proximal element 2806 results in further dislodging of occlusion material from the vessel wall and capturing at least a portion of the occlusion between the proximal and distal elements 2806, 2807. The proximal element 2806 is moved using a third slider on the handle 2802 of the retrieval device 2800.
As discussed above, in some embodiments, the proximal element 2806 can also rotate during the noted axial movement or rotate without any axial movement via a fourth slider on the handle 2802 of the retrieval device 2800.
In some embodiments, as depicted in
In various embodiments, the anchoring of the rigid distal element 2807 proximate the distal end of the tip portion followed by a mechanical expansion of the distal element 2807 using the first slider (as opposed to a Nitinol temperature-based expansion) provides the distal element 2807 a required minimum degree of rigidity to anchor in place within the lumen and/or preferably wedged into the occlusion.
Persons of ordinary skill in the art would appreciate that if the distal element 2807 is not rigid and not solidly anchored, the retrieval device 2800 may not have sufficient leverage to dislodge the occlusion.
In some embodiments, the anchoring of the distal element 2807 to the tip portion and the occlusion (in embodiment where the distal element 2807 is positioned within the occlusion) while attaining a required degree of rigidity locks the distal element 2807 in a desired location with respect to the occlusion, and allows the proximal element 2806 to move back and forth longitudinally with respect to the distal element 2807 and/or, as indicated above, rotate to dislodge the occlusion.
In at least one embodiment, the distal element 2807 is positioned and expanded within the occlusion (like a fishing hook), and, in another embodiment, the distal element 2807 is positioned and expanded distal to (or beyond) the occlusion.
In at least one embodiment, the proximal element 2806 is expanded proximal to (prior to) or within the occlusion, such that the proximal element 2806 can be moved all the way into the expanded (concave or cup-shaped) distal element to generate a vice-like grip and trap the occlusion between the proximal and distal elements 2806, 2807.
In some embodiments, once the occlusion is trapped between the proximal and distal elements 2806, 2807, the distance between the proximal element 2806 and the distal element 2807 can be reduced further such that the proximal element 2806 moves all the way into or proximate the distal element 2807.
At step 3116a, aspiration is used to concurrently remove at least a portion of the occlusion.
In some embodiments, aspiration is performed by applying negative pressure (or suction) at a proximal end of the aspiration catheter.
At step 3118a, the proximal and distal elements 2806, 2807 are mechanically compressed/collapsed, pulled back and removed from the lumen.
In some embodiments, the portion of the occlusion captured between the proximal and distal elements 2806, 2807 is removed by pulling out the proximal element 2806, the portion of the occlusion and the distal element 2807 together from the lumen of the patient.
In some embodiments, a first portion of the occlusion captured between the proximal and distal elements 2806, 2807 is removed by pulling out the proximal element 2806, the first portion of the occlusion and the distal element 2807 while a remaining second portion is aspirated using an aspiration catheter.
In various embodiments, the exact technique of removing the occlusion varies depending upon factors such as, but not limited to, the anatomical location of the occlusion within the patient's body, and the complexity and density of the occlusion.
However, in various embodiments, removal of the occlusion involves some degree of moving the proximal element 2806 relative to the distal element 2807 to dislodge, trap and aspirate the occlusion.
Referring now to
In some embodiments, treatment of DVT involves removing an occlusion from a lumen of a patient's deep vein/vessel.
At step 3102b, a guidewire is advanced through the lumen of the patient and positioned through the occlusion.
At step 3104b, an aspiration catheter 2835 is advanced over a guidewire such that a distal end of the aspiration catheter 2835 is positioned at or proximate the occlusion.
At step 3106b, a delivery catheter 2848 is advanced through the aspiration catheter 2835 such that a distal end of the delivery catheter 2848 lies proximate the distal end of the aspiration catheter 2835.
At step 3108b, a retrieval device 2800 is deployed through the delivery catheter 2848 so that a distal element mounted on a tip portion of the retrieval device 2800 is positioned within or all the way through and beyond the occlusion.
At step 3110b, the distal element 2807 is mechanically expanded to a desired diameter using a first slider on the handle 2802 of the retrieval device 2800.
In some embodiments, the distal element 2807 is a mechanically expandable and rigid anchor fixedly attached proximate to a distal end of the tip portion.
At step 3112b, a proximal element 2806 (also mounted on the tip portion) is mechanically expanded to a desired diameter using a second slider on the handle 2802 of the retrieval device 2800.
At step 3114b, the proximal element 2806 is moved axially (in one or more back and forth motions) along the tip portion to dislodge the occlusion (and curettage the vessel).
In some embodiments, the axial fore and aft movement of the proximal element 2806 similarly results in further dislodging of occlusion material from the vessel wall and capturing at least a portion of the occlusion between the proximal and distal elements 2806, 2807.
The proximal element is moved using a third slider on the handle of the retrieval device.
By way of example, in some embodiments, as depicted in
In various embodiments, the anchoring of the rigid distal element 2807 proximate the distal end of the tip portion followed by a mechanical expansion of the distal element 2807 using the first slider (as opposed to a Nitinol temperature-based expansion) similarly provides the distal element 2807 a required minimum degree of rigidity to anchor in place within the lumen and/or preferably wedged into the occlusion.
Persons of ordinary skill in the art would appreciate that if the distal element 2807 is not rigid and not solidly anchored, the retrieval device 2800 may not have sufficient leverage to dislodge the occlusion.
In some embodiments, the anchoring of the distal element 2807 to the tip portion and the occlusion (in embodiment where the distal element 2807 is positioned within the occlusion) while attaining a required degree of rigidity locks the distal element 2807 in a desired location with respect to the occlusion, and allows the proximal element 2806 to move back and forth longitudinally with respect to the distal element 2807 and/or, as indicated above, rotate to dislodge the occlusion.
In at least one embodiment, the distal element 2807 is positioned and expanded within the occlusion (like a fishing hook), and in another embodiment the distal element 2807 is positioned and expanded distal to (or beyond) the occlusion.
In at least one embodiment, the proximal element 2806 is expanded proximal to (prior to) or within the occlusion, such that the proximal element 2806 can be moved all the way into the expanded (concave or cup-shaped) distal element to generate a vice-like grip and trap the occlusion between the proximal and distal elements.
In some embodiments, once the occlusion is trapped between the proximal and distal elements 2806, the distance between the proximal element 2806 and the distal element 2807 can be reduced further such that the proximal element 2806 moves all the way into or proximate the distal element 2807.
At step 3116b, aspiration is used to concurrently remove at least a portion of the occlusion.
In some embodiments, aspiration is performed by applying negative pressure (or suction) at a proximal end of the aspiration catheter.
At step 3118b, the proximal and distal elements 2806 are mechanically compressed/collapsed, pulled back and removed from the lumen.
In some embodiments, the portion of the occlusion captured between the proximal and distal elements 2806 is removed by pulling out the proximal element 2806, the portion of the occlusion and the distal element 2807 together from the lumen of the patient.
In some embodiments, a first portion of the occlusion captured between the proximal and distal elements 2806, 2807 is removed by pulling out the proximal element 2806, the first portion of the occlusion and the distal element 2807 while a remaining second portion is aspirated using an aspiration catheter.
In various embodiments, the exact technique of removing the occlusion varies depending upon factors such as, but not limited to, the anatomical location of the occlusion within the patient's body, and the complexity and density of the occlusion. However, in various embodiments, removal of the occlusion involves some degree of moving the proximal element 2806 relative to the distal element 2807 to dislodge, trap and aspirate the occlusion.
In various embodiments, the retrieval device 3204 is one of devices 2800, 2900 or 3000 of the present specification.
As depicted in
Next (as also described earlier in the specification with respect to
In at least one embodiment, the distal element 3208 does not expand fully to form a cup like structure, instead the distal element 3208 expands until an outer wall of the expanded distal element 3208 touches internal walls of the artery 3200. In other words, a distal element expands to a diameter equal to an internal diameter of a vein/artery/lumen into which a tip portion of a retrieval device is inserted and creates a radial force to macerate an occlusion which can then be removed by pulling out the retrieval device from the vasculature.
In some embodiments, a tip portion 3704 of the retrieval device 3700 includes proximal and distal elements 3710, 3712 that are self-expanding elements of Nitinol wire mesh or of woven Nitinol fabric. The proximal element 3710 is the only component of the device 3700 that is actuated (using a knob on a handle of the device 3700) to move axially and, in some embodiments, rotate in order to dislodge and mobilize the clot 3702. The distal element 3712 is fixedly mounted on the tip portion 3704 and provides embolic protection.
In various embodiments, the proximal and distal elements 3710, 3712 are three dimensional geometric shapes and can be approximately spherical, elliptical or cylindrical in shape when in fully expanded states.
According to the invention, the proximal and distal elements 3710, 3712 can similarly comprise one of the aforementioned outer coatings, e.g., a biodegradable polymer composition comprising a pharmacological agent.
At step 3750a (
In some embodiments, the proximal and distal elements 3710, 3712 are flexible to self-expand and contract in accordance with a diameter of a lumen of the nerve vessel 3705.
As depicted in
At step 3750b (
As depicted in
At step 3750d (
Next, at step 3750e (
Finally, at step 3750l (
Referring now to
In at least one embodiment, in order to retrieve an occlusion from a lumen of a patient's nerve vessel, at step 3802, an aspiration catheter (or a delivery catheter or a sheath) of the retrieval device is positioned near the occlusion with a distal end of a tip portion of the retrieval device, protruding from the aspiration catheter (or delivery catheter or sheath), being positioned within or all the way through and beyond the occlusion. In at least one embodiment, a handle of the retrieval device is used to maneuver and position the tip portion.
At step 3804, as the tip portion is positioned, a distal element, which is fixedly attached to the distal end of the tip, and a proximal element, slidably coupled to a proximal end of the tip portion, self-expand to respective first and second diameters.
In some embodiments, the first and second diameters are same and in accordance with a diameter of the lumen of the nerve vessel. In some embodiments, the first and second diameters are dissimilar.
In at least one embodiment, the distal element 3712 is positioned within the occlusion, and in another embodiment the distal element 3712 is positioned distal to (or beyond) the occlusion.
In at least one embodiment, the proximal element 3710 is positioned proximal to (prior to) or within the occlusion, such that the proximal element 3710 can be moved all the way up to the expanded distal element 3712 to generate a vice-like grip and trap the occlusion between the proximal and distal elements 3710, 3712.
In some embodiments, once the occlusion is trapped between the proximal and distal elements 3710, 3712, the distance between the proximal element 3710 and the distal element 3712 can be reduced further such that the proximal element 3710 moves proximate the distal element 3712.
At step 3806 the proximal element is moved axially (in one or more to-and-fro motions) along the tip portion to dislodge the occlusion in a manner that captures the occlusion between the proximal and distal elements 3710, 3712.
At step 3808, in some embodiments, the occlusion captured between the proximal and distal elements 3710, 3712 is removed by retracting the proximal element 3710, aspirating the occlusion and thereafter retracting the distal element 3712 into the aspiration catheter. The distal and proximal elements 3710, 3712 self-contract into the aspiration catheter as they are retracted. In other words, first the proximal element 3710 is retracted into the aspiration catheter, then the occlusion (dislodged and captured between the distal and proximal elements) is aspirated through the aspiration catheter and finally the distal element 3712 is also retracted into the aspiration catheter.
In some embodiments, a first portion of the occlusion captured between the proximal and distal elements 3710, 3712 is removed by pulling out the proximal element 3710, the first portion of the occlusion and the distal element 3712 while a remaining second portion is aspirated using the aspiration catheter.
In various embodiments, the exact technique of step 3808 varies depending upon factors such as, but not limited to, the anatomical location of the occlusion within the patient's body, and the complexity and density of the occlusion.
However, in various embodiments, step 3808 involves some degree of moving the proximal element 3710 relative to the distal element 3712 to dislodge and trap the occlusion.
In some embodiments, a retrieval device of the present specification is configured to have at least one of the proximal and distal elements 3710, 3712 be formed of first and second braids respectively and positioned on a tip portion of the device.
The first and second braids are coupled onto a shaft that is torqued. As the shaft is untorqued, each of the first and second braids expands and pulls together to form a football shape.
Thus, in some embodiments, a centrifugal force applied to the shaft (via the handle) causes the shaft to spin or rotate to untorque and expand the first and second braids.
In some embodiments, a portion of the first or second braid is covered so that as the covered braid expands, the cover acts as a funnel for aspiration or curettage of the clot material.
In some embodiments, a proximal portion of the first or second braid is covered while the distal portion is open or not covered. Since the open portion is distal, affected aspiration is directed, isolated or focused onto fluid/clot distal to the tip portion.
It should be appreciated that in preferred embodiments a retrieval device of the present specification is characterized by a) a proximal element and a distal element being able to expand or open as well as contract or close independently, b) the proximal and distal elements not being self-expanding/self-contracting but rather only expand or contract mechanically by the application/removal of force, and c) the proximal element being configured to move relative to the distal element or vice-versa.
However, in some embodiments, a retrieval device of the present specification is characterized by a) a single physically manipulable interface such as, for example, a knob, slider or button being configured to expand or contract the proximal and distal elements concurrently, b) the proximal and distal elements being configured to partially self-expand, and/or c) the proximal and distal elements being configured to move axially together in a coordinated fashion.
In various embodiments, a retrieval device (such as, the devices 2800, 2900, 3000, 3304, 3504 and 3700) of the present specification is configured to have a plurality of characteristics, such as follows:
In some embodiments, the retrieval device includes proximal and distal elements that are three dimensional (3D) geometric shapes.
In some embodiments, the proximal and distal elements are independently expandable, compressible, and moveable relative to each other yet mounted on a single delivery system.
In some embodiments, each geometric shape (proximal and distal elements) can independently expand even while the other geometric shape or element cannot expand, is blocked or is being moved. The retrieval device enables active (controlled) mechanical expansion of each of the proximal and distal elements by the user.
In some embodiments, the retrieval device includes a handle system at a proximal end, wherein the handle system includes three sliders, levers, dials, or buttons that allow for the independent expansion/contraction of the distal element, independent expansion/contraction of the proximal element, and independent axial movement of the proximal element relative to the distal element.
In some embodiments, the retrieval device includes a handle system at a proximal end, wherein the handle system includes four sliders, levers, dials, or buttons that allow for the independent expansion/contraction of the distal element, independent expansion/contraction of the proximal element, independent axial movement of the proximal element relative to the distal element, and independent rotation of the proximal element.
In some embodiments, the handle includes a plurality of gradations such as, for example, three gradations of low, medium and high, five gradations ranging from low to high or eight gradations ranging from low to high. Each gradation is indicative of a corresponding predefined diameter of the proximal and distal elements in expanded states. The three slide buttons can be actuated to any one of the plurality of gradations and then détente to that position.
In some embodiments, handle or axial force (that is, the pulling or pushing force that comes into force due to actuation of each of the three slide buttons) ranges from 0.0 newtons to 20.0 newtons and generally up to 60.0 newtons, preferably from 9.0 newtons to 15.0 newtons. In other words, the handle or axial force is a force required to, for example, pull on one of the shafts to expand the braid wires of any of the proximal or distal elements.
In some embodiments, therefore, the proximal and distal elements are capable of delivering controlled radial force.
In some embodiments, the retrieval device enables one geometric shape (that is, the proximal element) to move linearly fore and aft while another tandem geometric shape (that is, the distal element) remains in place. Thus, the proximal element is configured to independently move forward and backward along a wire/lumen even while the distal element cannot expand, is blocked, is stationary or is being moved in a different direction.
In some embodiments, the geometric shapes (proximal and distal elements) can perform multiple passes without re-sheathing—that is, position the elements, expand the elements, drag out embolic material, flatten the elements, position the elements, expand the elements, drag out embolic material and so on. Stated differently, the retrieval device is capable of multiple (thrombus related) extraction passes without the need to re-sheath or reintroduce the device.
In some embodiments, a minimum distance between the proximal and distal elements ranges from 0.0 mm to 5.0 mm and a maximum distance between the proximal and distal elements 2806, 2807 ranges from 60.0 mm to 400.0 mm.
In some embodiments, the retrieval device enables an operator to actively adjust the respective diameters of the individual geometric shapes (proximal and distal elements) across a range of diameters.
In some embodiments, each geometric shape (proximal and distal elements) is configured to independently apply a radial force preferably in a range of 10.0 newtons to 14.0 newtons. More generally, each of the proximal and distal elements can be mechanically expanded to allow for controlling an amount of radial force applied ranging from 0.0 newtons to 40.0 newtons and, in some embodiments, generally ranging from 0.0 newtons to 25.0 newtons. Therefore, each element can be expanded to reach a radial force level and maintain the element at the reached radial force level without further action.
It should be appreciated that force is a function of a length of contact of each of the proximal and distal elements with a vessel wall. For example, in a 5.0 mm vessel, the length of contact of an element could be 0.9 inches while in a 12.0 mm vessel, the length of contact of the element could be 0.6 inches. However, the degree of radial force is not likely the same across an entire length of contact (in fact, it can be more at some portions and less in other portions of the contact length). Therefore, “radial force” refers to an average force applied along the length of contact and is not necessarily equal along the entire length of contact.
In some embodiments, the retrieval device enables the operator to actively adjust the exerted radial forces of the individual geometric shapes (proximal and distal elements) across a range of diameters and/or within a fixed diameter.
In some embodiments, the retrieval device enables each geometric shape (proximal and distal elements) to be simultaneously and independently adjusted with respect to size, shape, location and radial force relative to the other.
In some embodiments, the retrieval device provides continuous distal embolic protection (using the distal element) while simultaneously engaging in remote proximal thrombectomy (using the proximal element). The distal embolic protection is enabled because the distal element opposes to the vessel wall and contains pores ranging from 0.01 inches to 0.08 inches, preferably 0.02 inches to 0.06 inches, encompassing a cross-sectional area of a blood vessel and thereby substantially blocking anything flowing out.
In some embodiments, the geometric shapes enable maceration of embolic material to fit through an aspiration catheter.
In some embodiments, the retrieval device can utilize linear travel and geometric shape apposition and compression to capture thrombus and remove it from arteries and veins. Thus, the proximal and distal elements can move relative to each other allowing capture and mechanical removal of material.
In some embodiments, the retrieval device can effectively be manually expanded into thrombus to capture material within a geometric shape (proximal element and/or distal element) itself prior to material extraction. In other words, the retrieval device can trap thrombus within the confines of the proximal and/or distal elements allowing for mechanical removal of thrombus.
In some embodiments, the distal element can independently invaginate on itself (to form a chalice) to capture embolic material mechanically. The distal element envelopes the embolic material when inverted and then when flattened, the embolic material is exposed. In other words, the distal element encloses at least a portion of the clot material by inverting a portion of the distal element.
In some embodiments, each geometric shape (proximal and distal elements) is configured to independently apply a pull force capable of removing, scraping, or dislodging clot material from a vessel wall thereby minimizing a need for aspiration. Thus, in some embodiments, the retrieval device enables removal of thrombus with minimal reliance on aspiration.
In some embodiments, both geometric shapes (proximal and distal elements) can be collectively used to apply a compressive force (on a thrombus) ranging from 0.0 newtons to 60.0 newtons, preferably in a range of 9.0 newtons to 15.0 newtons.
In some embodiments, the geometric shapes (proximal and distal elements) are configured to exert the radial, compressive, and pull forces using atraumatic surfaces.
In some embodiments, the retrieval device enables the geometric shapes (proximal and distal elements) adjusted so that a wide range of vessel lumen diameters can be treated using a single adjustable device.
In some embodiments, the retrieval device anchors itself distally to provide for a more stationary wire that improves the ability to advance catheters into distal anatomy and through tortuous vasculature.
In a preferred embodiment, the retrieval device does not rely on or require passive expansion of a self-expanding material to perform its thrombectomy functions. In other words, the geometric shapes (proximal and distal elements) expand reliably and mechanically to a particular diameter and a particular radial force, thereby allowing trapping and curettage of material from the vessel lumen and wall.
In some embodiments, the retrieval device utilizes its adjustable radial forces and its adjustable size to actively curettage the wall of an artery or vein.
In some embodiments, the retrieval device enables removal of thrombus by simultaneously capturing, compressing, dragging and curetting thrombotic material from vessel walls. In other words, the fore and aft (forward and backward) movement and rotation of the proximal element relative to the distal element enables curettage to separate and mobilize thrombus from vessel wall.
In some embodiments, the retrieval device can be used equally as well and in the same manner for extraction of acute, sub-acute and organized chronic thrombus in any anatomic location.
In some embodiments, the retrieval device includes a completed aspiration system.
In some embodiments, the retrieval device is capable of performing mechanical removal of PE and DVT.
In some embodiments, the single retrieval device is configured to perform both PE and DVT procedures.
In some embodiments, the retrieval device minimizes blood loss and tPA during extraction of thrombus from a vessel lumen.
Braid wire parameters for proximal and distal elements—in some embodiments, each of the proximal and distal elements is a geometric mesh structure of braid wire. In some embodiments, a braid includes 32 wires of 0.006 inches diameters each, 8 Pics (or PPI) per inch, of super elastic Nitinol and pattern: two over two under—resulting in mesh structure having a cell size of 0.92 inches×0.92 inches.
In various embodiments, following are some of the key parameters of the braid wire forming the geometric mesh structures (having a plurality of cells) of the proximal and distal elements:
A retrieval device, such as the device 2800, 2900 or 3000, of the present specification was introduced into venous structures of an 821b live swine to perform thrombectomy test procedures.
Once a tip portion was positioned for removal of an occlusion within the venous structures, proximal and distal elements were expanded, the proximal element slid to dislodge the occlusion and thereafter trapped between the proximal and distal elements (in accordance with the method of
A first test procedure was performed in the animal's right internal jugular vein (RIJV) having an initial diameter of 4.5 mm. During the first test, a handle force of 15.1 N was applied, the distal element was expanded to a diameter of 5.0 mm to exert a radial force of 13.0 N on the walls of the RIJV. After the first test, a post test diameter of the RIJV was measured to range between 4.0 mm and 5.0 mm.
A second test procedure was performed in the animal's left internal jugular vein (LIJV) having an initial diameter of 5.0 mm. During the second test, a handle force of 15.0 N was applied, the distal element was expanded to a diameter of 8.0 mm to exert a radial force of 13.0 N on the walls of the LIJV. After the second test, a post test diameter of the LIJV was measured to be 5.0 mm.
A third test procedure was performed in the animal's right external jugular vein (REJV) having an initial diameter of 8.0 mm. During the third test, a handle force of 10.0 N was applied, the distal element was expanded to a diameter of 11.0 mm to exert a radial force of 10.0 N on the walls of the REJV. After the third test, a post test diameter of the REJV was measured to range between 8.0 mm and 9.0 mm.
A fourth test procedure was performed in the animal's left external jugular vein (LEJV) having an initial diameter of 9.0 mm. During the fourth test, a handle force of 11.0 N was applied, the distal element was expanded to a diameter of 11.0 mm to exert a radial force of 11.0 N on the walls of the LEJV. After the fourth test, a post test diameter of the LEJV was measured to range between 7.0 mm and 8.0 mm.
A fifth test procedure was performed in the animal's right common iliac vein (RCIV) having an initial diameter of 14.0 mm. During the fifth test, a handle force of 7.0 N was applied, the distal element was expanded to a diameter of 16.0 mm to exert a radial force of 14.0 N on the walls of the RCIV. After the fifth test, a post test diameter of the RCIV was measured to be 14.5 mm.
A total of 5 retrieval device cycles, where each cycle comprises expanding the proximal element, capturing material, moving the proximal element, pulling out the material and moving the proximal element back, were performed in each of the first, second, third, fourth and fifth test procedures.
Table A summarizes values of a plurality of parameters associated with the test procedures.
Post procedures, H&E staining of the cross-sections of the venous structures (RIJV, LIJV, REJV, LEJV and RCIV) were performed by a veterinary pathologist as part of a histopathology study that used a left iliac vein as control vessel.
Table B summarizes results of the pathology evaluation.
In all specimens, the vascular integrity was intact and the histology of vascular elements essentially normal. The blood pooling and clotting were observed to be recent events and were considered to be artifactual as there was no definitive pathology associated with the veins. In some of the blood vessels, there was scattered endothelial cell loss, which was considered most likely also artifactual and due to venous extraction and handling.
As an example,
The model 3905 allows incorporation of a pre-made tube, of a predefined internal diameter, with mechanically characterized artificial thrombus spliced into the tube. A pre-made tube with artificial thrombus is also referred to collectively as a ‘cartridge.’
In some embodiments, an artificial thrombus is manufactured using a predetermined recipe of egg albumin, flour, water and food coloring.
The model 3905 further includes pressure transducers proximal and distal to a cartridge incorporated in the model 3905.
For the experimental use case study:
a) Fifteen cartridges are prepared such that each cartridge has a tube of 15.0 mm diameter and artificial thrombus or clot spliced into the tube. Weight of each of the empty tube cartridge (that is, without the thrombus) is recorded.
b) The fifteen cartridges are organized into first, second and third groups such that each group includes five cartridges.
c) The five cartridges of the first group are exposed to a microwave oven for 15.0 seconds, the five cartridges of the second group are exposed to a microwave oven for 30.0 seconds, and the five cartridges of the third group are exposed to a microwave oven for 45.0 seconds. Weight of each of the cartridges with microwaved thrombus is recorded.
d) Each of the fifteen cartridges with the microwaved thrombus is submerged in water for 30.0 minutes to saturate the microwaved thrombus with fluid. Weight of each of the cartridges with water saturated microwaved thrombus is recorded. Using, the weight of the empty tube cartridge and weight of the microwaved and water saturated cartridge, the approximate saturated thrombus weight is determined for each cartridge.
e) Modulus of Elasticity of the experimental artificial thrombus in each cartridge is determined after it is saturated. It should be appreciated, that each of the thrombi of the first group of five cartridges will have a first Modulus of Elasticity, each of the thrombi of the second group of five cartridges will have a second Modulus of Elasticity, and each of the thrombi of the third group of five cartridges will have a third Modulus of Elasticity. The third Modulus of Elasticity will be greater than the second Modulus of Elasticity which will be greater than the first Modulus of Elasticity. Thus, each group will have similar Modulus of Elasticity that increases from the first group through the second group and to the third group.
f) Place a cartridge into the non-pulsatile flow model 3805 that has a pressure transducer positioned proximal and distal to the occlusive thrombus cartridge.
g) The aspiration catheter is inserted through the hemostatic valve and positioned proximal to the thrombus cartridge.
h) The delivery catheter is inserted into the thrombus.
i) A pump, associated with the flow model 3905, is switched on in order to generate fluid flow through the model 3905.
j) Baseline pressures are measured proximal and distal to the occlusive thrombus cartridge.
k) A retrieval device (such as, the device 2800, 2900 or 3000) is inserted into the delivery catheter.
l) A tip portion of the retrieval device is unsheathed and a timer is started.
m) An operator now uses the retrieval device to extract the thrombus or clot. A continuous video recording is done of the thrombus extraction process in the tubing.
n) During the thrombus extraction process continuous pressure monitoring is performed both distal and proximal to the cartridge.
o) The timer is stopped when the thrombectomy is clinically completed.
Steps f) through o) are repeated for each of the fifteen cartridges.
The following exemplary data is derived as a result of the experimental steps performed above:
Steps a) to o) are repeated for first and second prior art devices to generate data comparable to the data pertaining to the retrieval device of the present specification. When compared with data of the first and second prior art devices, the retrieval device does the following:
In some embodiments, additional cartridges are prepared that have increasing Moduli of Elasticity of the artificial thrombi. Thereafter, the retrieval device is separately deployed in each of the additional cartridges until a point of failure is reached—that is, the point where it is no longer possible to manually expand the proximal and distal elements and remove thrombus/clot material. The same approach is followed for the first and second prior art devices.
Compared to the first and second prior art devices, the retrieval device of the present specification can open in thrombus/clot material that has a far greater Modulus of Elasticity than can the first and second prior art devices.
This study uses a closed-loop anatomical flow model for performing experimental thrombectomy using a retrieval device of the present specification (such as, the device 2800, 2900 or 3000).
The flow model has a proximal access hemostatic valved port that permits introduction of an aspiration catheter and a delivery catheter (such as, the aspiration catheter 2835 and delivery catheter 2848 of
The model also includes a distally located filter or collection trap that can capture distal emboli that occur during thrombectomy.
The model allows incorporation of a pre-made tube, of a predefined internal diameter, with mechanically characterized artificial thrombus spliced into the tube. A pre-made tube with artificial thrombus is also referred to collectively as a ‘cartridge.’
In some embodiments, an artificial thrombus is manufactured using a predetermined recipe of egg albumin, flour, water and food coloring. In accordance with at least one embodiment of the invention, the study uses an artificial thrombus, having a Modulus of Elasticity, that can be extracted by the retrieval device of the present specification but not by first and second prior art devices.
The model further includes pressure transducers proximal and distal to a cartridge incorporated in the model.
For the experimental use case study:
a) A video recording is made of the thrombus/clot extraction procedure and of the thrombus/clot distal embolization.
b) Measure pressures during the procedure.
c) Measure resistance to device extraction once it is deployed against a native PA (Pulmonary Artery) vessel wall that does not have clot in it.
d) Record the volume of fluid aspirated from the aspiration catheter during thrombus extraction.
The aforementioned study is repeated for the first and second prior art devices.
In the foregoing studies, the retrieval device of the present specification refers to any of the devices 2800, 2900 or 3000.
The foregoing studies are directed towards comparative abilities of the retrieval device of the present specification with respect to the first and second prior art devices to extract thrombus material that simulates sub-acute and organized thrombus encountered in Pulmonary Embolism (PE)/Deep Vein Thrombosis (DVT) clinical settings.
View 4002 of
View 4004 of
View 4006 of
Consequently, the discs and basket cannot achieve their designed outer diameters and therefore are unable to generate the radial force needed to extract sub-acute or organized thrombus. The discs and basket deform around the thrombus thereby failing to effectively remove it.
View 4032 of
View 4034 of
View 4036 of
It is observed from the study of
If the device 4020a is placed into firm or heterogeneous thrombus and one disc cannot open to its full discoid shape, then the other discs cannot fully expand as well. Thus, unlike the retrieval devices of the present specification, the three discs 4022, 4024, 4026 of the first prior art device 4020a are not functionally independent and cannot generate the radial force and fore/aft movement needed to remove organized fibrotic thrombus.
The thrombectomy capabilities refer to the comparative abilities of the devices to extract thrombus material that simulates sub-acute and organized thrombus encountered in Pulmonary Embolism (PE)/Deep Vein Thrombosis (DVT) clinical settings.
View 4042 of
View 4044 of
View 4046 of
Following are key take aways from the studies depicted in
Thus, the retrieval device of the present specification is characterized by at least the following:
In some embodiments, a retrieval device of the present specification is configured to have a single element that has a three-dimensional shape and is mounted on a tip portion of the device.
In some embodiments, the element takes a substantially spherical shape during an intermediate expanded state. When fully expanded, the element forms a chalice or cup shape.
In some embodiments, the tip portion includes a first tube that is proximal to a handle of the device and a second tube that is distal to the handle of the device. In some embodiments, the first tube is configured to axially telescope into the second tube.
In some embodiments, the element is a Nitinol mesh that has a proximal end and a distal end. The proximal end is coupled to the first tube and the distal end is coupled to the second tube.
In some embodiments, when a first knob, slider or button is slid forward towards the tip portion, the first tube moves axially into the second tube and the proximal end of the element moves distally (while the distal end of the element remains stationary) causing the element to expand into a substantially spherical shape. As the first knob or button is slid forward further, the proximal end of the element moves further close to the stationary distal end causing the element to take on a cup or chalice shape. Similarly, when the first knob or button is slid backward away from the tip portion, the first tube moves axially out of the second tube and the proximal end of the element moves proximally (while the distal end of the element remains stationary) causing the element to contract into a substantially cylindrical shape.
In some embodiments, when the first knob, slider or button is slid forward towards the tip portion, the element rotates.
In some embodiments, when a second knob or button is slid forward towards the tip portion, the first and second tubes move distally together as one and the proximal and distal ends of the element move together distally causing the element to move distally away from the handle. Similarly, when the second knob or button is slid backward away from the tip portion, the first and second tubes move proximally together as one and the proximal and distal ends of the element move together proximally causing the element to move proximally towards the handle. Thus, sliding the second knob or button forward causes the element to move forward or distally while sliding the second knob or button backward causes the element to move backward or proximally.
The retrieval device 4100 comprises a first unit 4190 that includes a handle 4102 coupled to a tip portion 4104 via telescoping tubes wherein the handle 4102 is configured to steer the tip portion 4104 in proximity to an occlusion.
The retrieval device 4100 further comprises a second unit 4192 that includes an aspiration catheter 4135 having a syringe 4137, a one-way valve 4139 and a port 4142, where the port is coupled to a proximal end 4144 of the aspiration catheter 4135.
In at least one embodiment, the one-way valve is configured to direct suction through the aspiration catheter 4135.
For use during a procedure, the tip portion 4104 is placed into a delivery catheter 4148 and thereafter the delivery catheter 4148 is inserted into the aspiration catheter 4135, and follows through to port 4142, so that at least the tip portion 4104 projects distally from a distal end 4146 of the aspiration catheter 4135.
In accordance with aspects of the present specification, the device 4100 is configured to enable an operator to single-handedly operate/actuate the handle portion 4102 to mechanically expand, contract, and/or rotate element 4106.
In at least one embodiment, a first slider, knob, button, or other actuation mechanism 4114 is configured to mechanically expand, contract and/or rotate element 4106.
In at least one embodiment, a second slider, knob, button, or other actuation mechanism 4120 is configured to axially move element 4106 relative to the tip portion 4104.
In at least one embodiment, the first slider, knob, button, or other actuation mechanism 4114 and the second slider, knob, button, or other actuation mechanism 4120 are positioned in an arc around an external surface of the handle such that each of the first and second actuation mechanisms are at the same location, or within 3.0 inches, axially along the length of the handle.
In another embodiment, the handle 4102 comprises one or more actuation mechanisms to deliver medications and, in particular, deliver tPA (tissue Plasminogen Activator) and/or activate an aspiration.
In at least one embodiment, a method of treatment would include infusing an aforementioned thrombolytic, e.g., tPA, into at least one lumen positioned within the catheter 4148.
In some embodiments, the infusion is performed at the outset of the pulmonary embolism or deep vein thrombosis treatment process, while the member 4106 is still housed within the catheter 4148, thereby covering the unexpanded element 4106 in tPA.
In some embodiments, the infusion is performed at the outset of the pulmonary embolism or deep vein thrombosis treatment process, while element 4106 is still housed within the catheter 4148, directed through a distal end of the catheter 4148, and injected directly into the clot prior to inserting and expanding element 4106.
In another embodiment, the catheter and handle, in combination, are configured to deliver ultrasonic energy to a clot to accelerate lytic dispersion, drive medications deeper into the clot, speed the breakdown of the clot, and/or degenerate or unwind the fibrin quicker.
In at least one embodiment, the catheter comprises an ultrasonic core in parallel with the elongated wire extending axially through the catheter lumen. The ultrasonic core is in electrical communication with a control unit positioned external to the catheter.
A proximal end of the handle would preferably have one or more leads in electrical communication with the ultrasonic core that would extend outward from the handle and be configured to connect to the control unit.
During the pulmonary embolism or deep vein thrombosis treatment process, the ultrasonic energy would be activated, using the control unit, at the beginning of the treatment upon delivery of the medications, as described above.
In some embodiments, an ultrasonic core energy generator runs through the center of the catheter.
In some embodiments, the ultrasonic core energy generator includes a control unit configured to manage the generator. In some embodiments, a proximal end of the handle includes leads plug into the control unit.
In accordance with some aspects of the present invention, the first and second units 4190, 4192 are manufactured as separate standalone units or devices. This is advantageous in that a physician can use the first unit 4190 with any third-party aspiration catheter.
In some embodiments, the aspiration catheter 4135 is available with a plurality of external diameters such as, but not limited to, 12 Fr, 16 Fr, 20 Fr, and 24 Fr (where Fr represents French scale or gauge system).
In some embodiments, the syringe 4137 has an exemplary, non-limiting, volume of 60.0 cubic centimeters.
In some embodiments, for use in treatment of pulmonary embolism a length of the delivery catheter 4148 is in a range of 80.0 cm to 160.0 cm, preferably 120.0 cm.
In some embodiments, for use in treatment of pulmonary embolism the aspiration catheter 4135 has different lengths for different external diameters. For example, an aspiration catheter of 16 Fr has a length in a range of 70.0 cm to 160.0 cm, preferably 112.0 cm, an aspiration catheter of 20 Fr has a length in a range of 60.0 cm to 150.0 cm, preferably 106.0 cm, and an aspiration catheter of 24 Fr has a length in a range of 50.0 cm to 130.0 cm, preferably 90.0 cm.
In some embodiments, for use in treatment of deep vein thrombosis a length of the delivery catheter 4148 is in a range of 40.0 cm to 120.0 cm, preferably 80.0 cm.
In some embodiments, for use in treatment of deep vein thrombosis a length of a 16 Fr aspiration catheter 4135 is 65.0 cm.
In some embodiments, for use in treatment of right heart/atrium, the aspiration catheters can range from 24 Fr with a length of 90.0 cm to 28 Fr with a length of 70.0 cm.
In some embodiments, for use in treatment of IVC/SVC (Inferior Vena Cava/Superior Vena Cava), the aspiration catheters can range from 24 Fr with a length of 90 cm to 28 Fr with a length of 70 cm.
In some embodiments, at least one pressure transducer or sensor 4109 (such as, for example, a fiber-optic pressure sensor, electro-mechanical pressure sensor and hydraulic pressure sensor) is positioned at a distal end of aspiration catheter 4135.
In some embodiments, the pressure transducer(s) or sensor(s) 4109 are in the form of an elongated member that is co-extruded into the aspiration catheter 4135 so that the elongated member runs along a full length of the aspiration catheter 4135.
In some embodiments, the pressure transducer(s) or sensor(s) 4109 are in electrical communication with electronic circuitry located in a handle 4102 of the first unit 4190.
In some embodiments, the handle 4102 includes a pressure display 4121. In various embodiments, the pressure transducer(s) or sensor(s) 4109 are configured to sense a pressure change or drop and, in particular, provide the physician with an indication that, as the occlusion is removed, there is an associated change of pressure indicative of a right side drop in right heart pressure. A right-side drop in right heart pressure indicates that a problematic occlusion is being successfully removed.
In some embodiments, the tip portion 4104 has a proximal end 4150 and a distal end 4152.
During operation of the device 4100, the tip portion 2804 is inserted into, for example, a blood vessel for removing an occlusion while the handle portion 4102 remains in an operator/user's hands.
During insertion of the device 4100 into the blood vessel, the distal end 4152 of the tip portion 4104 enters the blood vessel first and is placed in close proximity to the occlusion within the blood vessel by using the handle 4102 to maneuver the insertion of the tip portion 4104 in a desired position in the blood vessel.
The tip portion 4104 comprises element 4106, which in at least one embodiment, is a mechanically expandable pusher ball that is slidably mounted proximate the proximal end 4150 of the tip portion 4104. The mechanical expansion is in contrast to a non-mechanical expansion occurring because a shape memory material is naturally configured to adopt a pre-defined shape without mechanical force requiring to be applied.
In various embodiments, element 4106 is a substantially curved structure. In some embodiments, the element 4106 is a three-dimensional (3D) shape.
In at least one embodiment, the element 4106 is a braided structure made of interwoven wires such that the structure has a plurality of open areas (allowing egress from outside the element into the internal volume of the element) formed by the braid.
The open areas, relative to the total surface area of the element 4106 is in a range of 1% to 99% of the total surface area.
In at least one embodiment, the element 4106 has a high percentage of open surface area thereby allowing the element 4106 to capture more clot material.
According to the invention, the element 4106 can be of any shape, including spherical, elliptical, conical, polygonal, cylindrical, stent, chalice cup, umbrella, concave structure, convex structure, half-sphere, sphere, windsock, dumbbell, star, polygon, lever or a combination of such shapes.
In at least one embodiment, as shown in
In some embodiments, when the element 4106 is mechanically expanded, a proximal portion and a distal portion of the element expands first followed by a center portion. In some embodiments, each of the respective proximal, distal and center portions of the element 4106 can expand at different rates.
In some embodiments, the element 4106 can be heterogeneous, having different characteristics including, without limitation, radial force, shape, size (for example, thickness, diameter), pore size (for example, mesh pore size or open areas as described above), and external coating.
Referring back to
In some embodiments, the tip portion 4104 comprises at least two flexible telescoping tubes, which, when manipulated together, enable an operator/doctor to axially move, expand, contract or rotate element 4106 to dislodge and remove the occlusion.
In some embodiments, element 4106 is fabricated from a Nitinol wire mesh having a plurality of mesh pores, lattices or cells.
In some less preferred embodiments, element 4106 is an inflatable device including, but not limited to, an inflatable balloon.
In some embodiments, element 4106 can be characterized by its ability to apply a variable radial force by virtue of the mechanical expansion being applied to the structure and the stiffness or rigidity across sub-regions of the element 4106.
For example, in some embodiments, the expansion of element 4106 to a first size (defined by an area or volume encompassed by the element) can be characterized by a first radial force that first size can apply to surrounding materials.
The expansion of element 4106 to a second size (defined by an area or volume encompassed by the element that is larger than the first size) can be characterized by a second radial force that second size can apply to surrounding materials, where the second radial force is different from the first radial force.
In some embodiments, each of the first and second radial forces are in a range of 2.0 newtons to 20.0 newtons, preferably 4.0 newtons to 12.0 newtons. The mechanical expansion allows for the intermittent, controlled expansion of the element 4106 so that it can adopt and retain the shape of a first size (having a first area or volume), a second size (having a second area or volume), a third size (having a third area or volume), or a fourth size (having a fourth area or volume) under the control of the user and throughout the length of a procedure where the fourth size is bigger than the third size which is bigger than the second size which is bigger than the first size.
In some embodiments, element 4106 can be characterized by its ability to resist an application of a radial force, thereby maintaining its expanded shape, by virtue of the mechanical expansion being applied to the structure and the stiffness or rigidity across sub-regions of the element 4106.
By way of example, in some embodiments, the expansion of element 4106 to a first size (defined by an area or volume encompassed by the element) can be characterized by an ability to resist (and therefore avoid collapse or compression of the first size) from a first radial force.
The expansion of element 4106 to a second size (defined by an area or volume encompassed by the element that is larger than the first size) can be characterized by an ability to resist (and therefore avoid collapse or compression of the second size) from a second radial force that is different from the first radial force.
In some embodiments, each of the first and second radial forces are in a range of 2.0 newtons to 20.0 newtons, preferably 3.0 newtons to 15.0 newtons, more preferably 4.0 newtons to 12.0 newtons.
The mechanical expansion allows for the intermittent, controlled expansion of element 4106 so that it can adopt and retain the shape of a first size (having a first area or volume), a second size (having a second area or volume), a third size (having a third area or volume), or a fourth size (having a fourth area or volume) under the control of the user and throughout the length of a procedure where the fourth size is bigger than the third size which is bigger than the second size which is bigger than the first size.
It should further be appreciated that element 4106 is adapted to not collapse or compress when positioned against blood flow that applies a hydrostatic pressure in a range of 80.0 mm Hg to 250.0 mm Hg. This is particularly valuable in arterial clot removal where the hydrostatic pressure level often causes other structures, particularly self-expanding structures, to compress or collapse.
In at least one embodiment, a physician uses any of the embodiments disclosed herein by
According to the invention, the proximal element 4106 can similarly comprise one of the aforementioned outer coatings, e.g., a biodegradable polymer composition comprising a pharmacological agent.
In some embodiments, the tip portion 4104 comprises a plurality of telescoping tubes, such as at least 2 telescoping tubes.
As depicted in
In at least one embodiment, the two tubes 4130 and 4125 are arranged as a coaxial array of telescopic tubes, wherein the first tube 4130 is designed to be able to move axially relative to the second tube 4125 which is fixed relative to the handle portion 4102.
In some embodiments, the first tube 4130 can be axially expanded or contracted relative to the second tube 4125 by using the handle portion 4102. In at least one embodiment, the telescoping tubes 4130 and 4125 are made of Nitinol.
In at least one embodiment, element 4106 has a proximal end 4160 and a distal end 4162. The distal end 4162 of element 4106 is fixedly attached to the second tube 4125 at a point 4128, while the proximal end 4160 is fixedly attached to the first tube 4130 at a point 4129 in both expanded and non-expanded states of the element 4106.
In various embodiments, in a non-expanded state, element 4106 (comprising a plurality of wires) forms a wire mesh 4126 concentrically positioned around a lumen of the second tube 4125.
In some embodiments, a portion of the wire mesh 4126 is only attached at points 4128 and 4129, of an exterior surface of the second tube 4125 and the first tube 4130, respectively, while the remaining portion of the wire mesh 4126 is unattached and therefore free to expand or contract. Upon axial compression of the first tube 4130 relative to the second tube 4125, the wire mesh 4126 is induced to expand radially around the lumen of the second tube 4125. Similarly, upon axial decompression of the first tube 4130 relative to the second tube 4125, the wire mesh 4126 is induced to compress or contract radially around the lumen of the second tube 4125.
Stated differently, relative axial movement of the first tube 4130 and the second tube 4125 causes the proximal end 4160 to move closer to the distal end 4162, whereby the material comprising element 4106 and extending between the ends 4160 and 4162 is compressed and therefore expands outward. In contrast, as the proximal end 4160 moves away from the distal end 4162, the material comprising the element 4106 and extending between the ends 4160 and 4162 is stretched and therefore collapses down to, and elongates along, a body lumen.
Thus, element 4106 expands by having the proximal end 4160 move distally and contracts by having the proximal end 4160 move proximally while the distal end 4162 remains stationary in both cases.
In at least one embodiment, in an expanded state the element 4106 approximates an elliptical shape wherein, at least a portion of the wire mesh 4126 lies approximately perpendicular to the lumen of the second tube 4125.
In at least one embodiment, a diameter of an expanded element 4106 is approximately 16.0 mm.
In some embodiments, a fully expanded element 4106 is substantially elliptical or disc shaped as shown in
In some embodiments, a fully expanded element 4106 can be substantially spherical shaped while in a transient or less expanded state the element 4106 can take a substantially elliptical shape.
As previously discussed, in various embodiments, in an expanded state the element 4106 can take the form of a cylinder, stent, chalice cup, umbrella, concave structure, half-sphere, sphere, windsock, dumbbell, star, polygon, lever, or any other suitable shape configured for aiding retrieval of the occlusion.
As indicated above, element 4106 is further adapted to rotate.
Referring now to
In at least one embodiment, a distance between a distal end 4165 of the handle portion 4102 and the distal end 4152 of the tip portion 4104 is in a range of 0.5 mm to 110.0 cm, preferably 1.0 mm to 100.0 mm. The handle portion 4102 includes a first actuator, knob or button 4114 configured to enable the user to mechanically expand or contract the element 4106.
As indicated above, in some embodiments, the handle portion 4102 includes an optional second actuator, knob or button 4120 configured to enable the user to mechanically slide element 4106 forward distally from the handle portion 4102 or backwards proximally towards the handle portion 4102, i.e., axially move element 4106. The first and second knobs 4114, 4120 are slidably fitted into the groove 4112. The first knob 4114 is coupled with the first tube 4130 while the second knob 4120 is coupled with both the first and second tubes 4130, 4125.
Referring now to
When the first knob 4114 is moved away from the tip portion 4104 the first tube 4130 is caused to telescope out of the second tube 4125 thereby inducing an axial decompression (or elongation) of the first tube 4130 relative to the second tube 4125 between the proximal and distal ends 4129, 4128 of the wire mesh 4126. This causes the wire mesh 4126 (and therefore the element 4106) to contract radially around the lumen of the second tube 4125 and assume an unexpanded shape having a diameter lesser than a diameter in an expanded state or assume a fully unexpanded state.
When the second knob 4120 is moved in the groove 4112 distally towards the tip portion 4104, the element 4106 is caused to slide distally away from the handle 4102, whereas when the second knob 2820 is moved proximally away from the tip portion 4104 the element 4106 is caused to slide proximally towards the handle portion 4102.
In at least one embodiment, a diameter of a fully expanded element 4106 is approximately 16.0 mm. In various embodiments, the element 4106 can expand to a diameter depending upon an application/functional use of the device 4100. By way of example, for use in treatment of a pulmonary/large vessel having a diameter of in a range of 20.0 mm to 30.0 mm, the diameter of an expanded element 4106 ranges from 5.0 mm to 30.0 mm, preferably 10.0 mm to 25.0 mm, for use in treatment of a peripheral arterial/DVT vessel having a diameter ranging from 2.0 mm to 10.0 mm, the diameter of an expanded element 4106 ranges from 3.0 mm to 12.0 mm; for use in treatment of neuro vessels, the diameter of an expanded element 4106 ranges from 1.0 mm to 10.0 mm; for use in retrieval of an occlusion in the inferior vena cava (IVC) vessels, the diameter of an expanded element 4106 ranges from 35.0 mm to 40.0 mm; for use in treatment of biliary ducts, fistula de-clotting, hepatic bile ducts, brain blood vessels and peripheral arterial vessels (particularly in the hands and feet) having a lumen diameter less than 3.0 mm and even those less than 1.0 mm, the diameter of an expanded element 4106 ranges from 1.0 mm to 14.0 mm.
In some embodiments, the diameter of the element 4106, in a fully expanded state, ranges from 5.0 mm to 30.0 mm, preferably 10.0 mm to 25.0 mm, and more preferably 10.0 mm to 20.0 mm.
In some embodiments, the first knob 4114 locks (and thus, cannot be moved further forward) in a position in the groove 4112 when the element 4106 has expanded to a maximum diameter. Thus, sliding the first knob 4114 forward enables the user to expand the element 4106 to a plurality of intermediate diameters and up to a maximum permissible diameter.
In some embodiments, the first knob 4114 is provided with a “clutch” feature so that, when opposing pressure is experienced from walls of a blood vessel during expansion of the element 4106, the “clutch” clicks in so that the user does not over expand. This feature is advantageous since it prevents the user from damaging the blood vessel due to over expansion of the element 4106.
In some embodiments, the groove 4112 has a series of interlocking features along its length such that the first knob 4114 can be selectively engaged or disengaged from a locked position in the handle 4102 at a plurality of expanded diameters for the element 4106.
In some embodiments, the device 4100 utilizes a lead-screw mechanism for continuous adjustment of the diameters of element 4106 so that the first knob 4114 can be advanced or retracted to an infinitely variable number of positions in the groove 4112 and can be held in a desired position by using a friction based locking mechanism, in order for the element 4106 to attain a desired diameter.
In at least one embodiment, a non-backdriving thread pattern in the lead-screw is used to provide a friction-brake when not actuated by the user, enabling continuous adjustment of the diameters of expanded element 4106.
In some embodiments, the first knob 4114 can be positioned at several different locations/positions along the length of the groove 4112, wherein each of the locations/positions corresponds to a different degree of expansion of the element 4106, and hence a different shape of the element 4106.
In at least one embodiment, by moving the second knob 4120, leading to advancing or retracting of the second tube 4125 and the first tube 4130 together as one, the element 4106 can be moved axially fore and aft along the tip portion 4104 in an expanded or collapsed state. In some embodiments, the element 4106 can be moved axially in a range from 1.0 mm to 8.0 cm, and preferably at least 6.0 cm.
In some embodiments, the first tube 4130 extends from the handle portion 4102 to the element 4106 and is co-axial with the second tube 4125.
Referring to
Referring back to
Thus, in various embodiments, the element 4106 expands to a particular diameter and a particular radial force, thereby allowing trapping and curettage of thrombus or clot material from a vessel lumen and wall.
In some embodiments, the retrieval device 4100 utilizes its adjustable radial forces and its adjustable size to actively curettage the wall of an artery or vein. In some embodiments, the retrieval device 4100 enables removal of thrombus by simultaneously capturing, compressing, dragging and curetting thrombotic material from vessel walls.
In at least one embodiment, element 4106 is configured to capture, and/or contain, a size of clot or thrombus material in a volume range of 0.01 ml to 100.0 ml.
In some embodiments, the handle portion 4102 includes a plurality of gradations such as, for example and by way of example only, three gradations of low, medium and high, five gradations ranging from low to high or eight gradations ranging from low to high. Each gradation is indicative of a corresponding predefined diameter of the element 4106 in expanded states.
The two slide buttons 4114 and 4120 can be actuated to any one of the plurality of gradations and then détente to that position.
While in some embodiments, the handle portion 4102 includes two buttons 4114 and 4120 to manipulate the element 4106, in alternate embodiments fewer than two buttons can be used. By way of example, in some embodiments, a clinician's use of the device 4100 is monitored over a predefined number of uses or operations of the device 4100 while performing mechanical thrombectomy procedures.
Based on the monitoring, a preferred sequence of deployment of element 4106 is determined and data indicative of the deployment sequence is stored in a memory (residing within the handle portion 4102 or remote from the handle portion 4102).
As a non-limiting illustration, the deployment sequence can include expanding element 4106 and then moving the element 4106 axially fore and aft for a cycle of, say, 5 reciprocations. Consequently, a single button (when actuated) is programmed to carry out the deployment sequence.
Of course, in some embodiments, the second button can still be used manually after the deployment sequence has been completed by the programmed button.
In some embodiments, a processing/computing means executing an Artificial Intelligence (AI) algorithm implements the deployment sequence, once the retrieval device 4100 is placed in vivo, to automatically expand the element 4106 and/or move the element 4106 axially.
In some embodiments of the invention there is thus provided a recanalization system comprising a handle and an elongate member, the elongate member comprising an occlusion dislodging member adapted to dislodge an occlusion in a cardiovascular vessel,
In some embodiments there is also provided a recanalization system comprising a handle and an elongate member, the elongate member comprising an occlusion dislodging member adapted to dislodge an occlusion in a cardiovascular vessel,
Referring now to
Referring now to
At step 4204, the aspiration catheter 4135 is advanced over the guidewire such that a distal end of the aspiration catheter 4135 is positioned at or proximate the occlusion.
At step 4206, the delivery catheter 4148 is advanced through the aspiration catheter 4135 such that a distal end of the delivery catheter 4148 lies proximate the distal end of the aspiration catheter 4135.
At step 4208, the retrieval device 4100 is deployed through the delivery catheter 4148 so that the distal end 4152 of the tip portion 4104 of the retrieval device 4100, protruding from the delivery catheter 4148 or sheath, is positioned within or all the way through and beyond the occlusion. This ensures that the element 4106, in a compressed or non-expanded state, is positioned within the occlusion.
At step 4210, element 4106, positioned within the occlusion, is mechanically expanded to a desired diameter (and therefore, to a corresponding shape and to exert a corresponding radial force).
In at least one embodiment, the first knob 4114 on the handle portion 4102 of the retrieval device 4100 is actuated to cause the wire mesh structure of the element 4106 to expand out. In some embodiments, upon expansion, the element 4106 is configured to resist compression from an applied force in a range of 0.0 newtons to 25.0 newtons.
At step 4212, the element 4106 is moved axially (in one or more fore and aft motions) and/or rotated to dislodge and scrape/curettage the occlusion.
In some embodiments, the occlusion can also be trapped into the mesh lattices of the element 4106 of the retrieval device 4100, for example.
In some embodiments, the handle portion 4102 is moved fore and aft to cause the tip portion 4104 and therefore the element 4106 to be moved fore and aft to dislodge and curettage the occlusion.
In another embodiment, the second knob 4120 is actuated to axially move element 4106 relative to the tip portion 4104. In some embodiments, element 4106 is configured to be moved axially in a range from 1.0 mm to 8.0 cm and preferably at least 6.0 cm.
At step 4214, the dislodged and scraped occlusion is removed or aspirated by applying a negative pressure through the aspiration catheter 4135.
In some embodiments, the fore and aft movement of the element 4106 further directs the dislodged and scraped occlusion towards the aspiration catheter 4135.
At step 4216, the element 4106 is collapsed or compressed. In some embodiments, the first knob 4114 is actuated to cause element 4106 to collapse or compress.
Finally, at step 4218, the element 4106, in collapsed or compressed state, is retracted and removed from the lumen of the patient.
In accordance with some aspects of the invention, the retrieval devices of the present specification, comprising at least one mechanically expandable element, can be used to remove gallstones during an ERCP procedure.
During an ERCP procedure an endoscope is advanced from a patient's mouth, down the esophagus and into the duodenal section of the small intestines.
Thereafter, the endoscope can be advanced proximate the patient's bile duct and a catheter is then advanced into the patient's a) bile duct; b) accessory pancreatic duct; c) main pancreatic duct; d) cystic duct; e) common hepatic duct; f) right hepatic duct; or g) left hepatic duct.
A contrasting agent is now injected, using the catheter, into the ducts to determine filling defects representative of occlusion such as stones or growth.
If one or more stones or other sludge are determined to be occluding the duct, a retrieval device of the present invention is advanced, over a wire, so that a tip portion is positioned proximate, into or all the way through the occlusion (depending upon the type of occlusion).
Thereafter, the proximal and distal elements are mechanically expanded and maneuvered (using a handle and physically manipulable interfaces on the handle) to remove the occlusion.
Referring now to
In some embodiments, the retrieval device is used to perform an ERCP procedure to remove a gallstone (hereinafter referred to as an ‘occlusion’).
At step 4402, a guidewire is advanced through the lumen of the patient and positioned through the occlusion. At step 4404, an aspiration catheter is advanced over the guidewire such that a distal end of the aspiration catheter is positioned at or proximate the occlusion.
At step 4406, a delivery catheter is advanced through the aspiration catheter such that a distal end of the delivery catheter lies proximate the distal end of the aspiration catheter.
At step 4408, a retrieval device is deployed through the delivery catheter so that a distal element mounted on a tip portion of the retrieval device is positioned within or all the way through and beyond the occlusion.
At step 4410, the distal element is mechanically expanded to a desired diameter using a first slider on a handle of the retrieval device. In some embodiments, the distal element is a mechanically expandable and rigid anchor fixedly attached proximate a distal end of the tip portion.
At step 4412, a proximal element (also mounted on the tip portion) is mechanically expanded to a desired diameter using a second slider on the handle of the retrieval device.
At step 4414, the proximal element is moved axially (in one or more back and forth motions) along the tip portion to dislodge the occlusion (and curettage the vessel). In some embodiments, the axial fore and aft movement of the proximal element results in capturing at least a portion of the occlusion between the proximal and distal elements.
In various embodiments, the anchoring of the rigid distal element proximate the distal end of the tip portion followed by a mechanical expansion of the distal element using the first slider (as opposed to a Nitinol temperature-based expansion) provides the distal element a required minimum degree of rigidity to anchor in place within the lumen and/or preferably wedged into the occlusion.
Persons of ordinary skill in the art would appreciate that if the distal element is not rigid and not solidly anchored, the retrieval device may not have sufficient leverage to dislodge the occlusion.
In some embodiments, the anchoring of the distal element to the tip portion and the occlusion (in embodiment where the distal element is positioned within the occlusion) while attaining a required degree of rigidity locks the distal element in a desired location with respect to the occlusion, and allows the proximal element to move back and forth longitudinally with respect to the distal element to dislodge the occlusion.
In at least one embodiment, the distal element is positioned and expanded within the occlusion (like a fishing hook), and, in another embodiment, the distal element is positioned and expanded distal to (or beyond) the occlusion.
In at least one embodiment, the proximal element is expanded proximal to (prior to) or within the occlusion, such that the proximal element can be moved all the way into the expanded (concave or cup-shaped) distal element to generate a vice-like grip and trap the occlusion between the proximal and distal elements.
In some embodiments, once the occlusion is trapped between the proximal and distal elements, the distance between the proximal element and the distal element can be reduced further such that the proximal element moves all the way into or proximate the distal element.
At step 4416, aspiration is used to concurrently remove at least a portion of the occlusion. In some embodiments, aspiration is performed by applying negative pressure (or suction) at a proximal end of the aspiration catheter.
At step 4418, the proximal and distal elements are mechanically compressed/collapsed, pulled back and removed from the lumen.
In some embodiments, the portion of the occlusion captured between the proximal and distal elements is removed by pulling out the proximal element, the portion of the occlusion and the distal element together from the lumen of the patient.
In some embodiments, a first portion of the occlusion captured between the proximal and distal elements is removed by pulling out the proximal element, the first portion of the occlusion and the distal element while a remaining second portion is aspirated using an aspiration catheter.
In various embodiments, the exact technique of removing the occlusion varies depending upon factors such as, but not limited to, the anatomical location of the occlusion within the patient's body, and the complexity and density of the occlusion.
However, in various embodiments, removal of the occlusion involves some degree of moving the proximal element relative to the distal element to dislodge, trap and aspirate the occlusion.
In accordance with some aspects, the retrieval devices of the present specification, comprising at least one mechanically expandable element, can be used to remove kidney stones.
In some embodiments, an endoscope is advanced from urethral meatus into a patient's bladder and then into the ureter.
Thereafter, a retrieval device of the present specification is advanced into the ureter so that a tip portion is positioned proximate the kidney stone.
The proximal and distal elements are then mechanically expanded and maneuvered (using a handle and physically manipulable interfaces on the handle) to remove the kidney stone.
It should be appreciated, that the retrieval device can also be advanced into the patient's renal pelvis to remove/extract stones.
Referring now to
In some embodiments, the retrieval device is advanced from urethral meatus into a patient's bladder and then into the ureter.
Thereafter, the retrieval device is advanced into the ureter so that a tip portion is positioned proximate the kidney stone (hereinafter referred to as an ‘occlusion’).
At step 4502, a guidewire is advanced through the lumen of the patient and positioned through the occlusion.
At step 4504, an aspiration catheter is advanced over the guidewire such that a distal end of the aspiration catheter is positioned at or proximate the occlusion.
At step 4506, a delivery catheter is advanced through the aspiration catheter such that a distal end of the delivery catheter lies proximate the distal end of the aspiration catheter.
At step 4508, a retrieval device is deployed through the delivery catheter so that a distal element mounted on a tip portion of the retrieval device is positioned within or all the way through and beyond the occlusion.
At step 4510, the distal element is mechanically expanded to a desired diameter using a first slider on a handle of the retrieval device. In some embodiments, the distal element is a mechanically expandable and rigid anchor fixedly attached proximate a distal end of the tip portion.
At step 4512, a proximal element (also mounted on the tip portion) is mechanically expanded to a desired diameter using a second slider on the handle of the retrieval device.
At step 4514, the proximal element is moved axially (in one or more back and forth motions) along the tip portion to dislodge the occlusion (and curettage the vessel).
In some embodiments, the axial fore and aft movement of the proximal element results in capturing at least a portion of the occlusion between the proximal and distal elements.
In various embodiments, the anchoring of the rigid distal element proximate the distal end of the tip portion followed by a mechanical expansion of the distal element using the first slider (as opposed to a Nitinol temperature-based expansion) provides the distal element a required minimum degree of rigidity to anchor in place within the lumen and/or preferably wedged into the occlusion.
Persons of ordinary skill in the art would appreciate that if the distal element is not rigid and not solidly anchored, the retrieval device may not have sufficient leverage to dislodge the occlusion.
In some embodiments, the anchoring of the distal element to the tip portion and the occlusion (in an embodiment where the distal element is positioned within the occlusion) while attaining a required degree of rigidity locks the distal element in a desired location with respect to the occlusion, and allows the proximal element to move back and forth longitudinally with respect to the distal element to dislodge the occlusion.
In at least one embodiment, the distal element is positioned and expanded within the occlusion (like a fishing hook), and, in another embodiment, the distal element is positioned and expanded distal to (or beyond) the occlusion.
In at least one embodiment, the proximal element is expanded proximal to (prior to) or within the occlusion, such that the proximal element can be moved all the way into the expanded (concave or cup-shaped) distal element to generate a vice-like grip and trap the occlusion between the proximal and distal elements.
In some embodiments, once the occlusion is trapped between the proximal and distal elements, the distance between the proximal element and the distal element can be reduced further such that the proximal element moves all the way into or proximate the distal element.
At step 4516, aspiration is used to concurrently remove at least a portion of the occlusion. In some embodiments, aspiration is performed by applying negative pressure (or suction) at a proximal end of the aspiration catheter.
At step 4518, the proximal and distal elements are mechanically compressed/collapsed, pulled back and removed from the lumen.
In some embodiments, the portion of the occlusion captured between the proximal and distal elements is removed by pulling out the proximal element, the portion of the occlusion and the distal element together from the lumen of the patient.
In some embodiments, a first portion of the occlusion captured between the proximal and distal elements is removed by pulling out the proximal element, the first portion of the occlusion and the distal element while a remaining second portion is aspirated using an aspiration catheter.
In various embodiments, the exact technique of removing the occlusion varies depending upon factors such as, but not limited to, the anatomical location of the occlusion within the patient's body, and the complexity and density of the occlusion. However, in various embodiments, removal of the occlusion involves some degree of moving the proximal element relative to the distal element to dislodge, trap and aspirate the occlusion.
In accordance with some aspects of the invention, at least one pressure transducer or sensor (such as, for example, a fiber-optic pressure sensor, electro-mechanical pressure sensor and hydraulic pressure sensor) is positioned at a distal end of an aspiration catheter that is used along with a retrieval device of the present specification during various procedures related to removal of an occlusion from a vessel lumen.
In some embodiments, the pressure transducer(s) or sensor(s) are in the form of elongated members that are co-extruded into the aspiration catheter so that the elongated member runs along a full length of the aspiration catheter. In some embodiments, the pressure transducer(s) or sensor(s) are in electrical communication with electronic circuitry located in a handle of the retrieval device. In some embodiments, the handle includes a pressure display.
In various embodiments, the pressure transducer(s) or sensor(s) are configured to sense a pressure change or drop and, in particular, provide the physician with an indication that, as the occlusion is removed, there is an associated change of pressure indicative of a right side drop in right heart pressure. A right side drop in right heart pressure indicates that a problematic occlusion is being successfully removed.
The above examples are merely illustrative of the many applications of the systems and methods of the present specification. Although only a few embodiments of the present invention have been described herein, it should be understood that the present invention might be embodied in many other specific forms without departing from the spirit or scope of the invention.
Therefore, the present examples and embodiments are to be considered as illustrative and not restrictive, and the invention may be modified within the scope of the appended claims.
This application is a continuation-in-part of U.S. patent application Ser. No. 18/112,093, filed on Feb. 21, 2023, which is a continuation of U.S. patent application Ser. No. 17/572,206, filed on Oct. 10, 2022, now U.S. Pat. No. 11,589,881, which is a continuation of U.S. patent application Ser. No. 17/450,978, filed Oct. 14, 2021, which is a continuation-in-part application of U.S. patent application Ser. No. 17/127,521, filed on Dec. 18, 2020, now U.S. Pat. No. 11,583,301, which is a continuation application of U.S. patent application Ser. No. 16/205,632, filed on Nov. 30, 2018, now U.S. Pat. No. 10,898,215, which is a divisional application of U.S. patent application Ser. No. 15/953,151, filed on Apr. 13, 2018, now U.S. Pat. No. 10,172,634, which claims the benefit of U.S. Provisional Application No. 62/653,247, filed on Apr. 5, 2018, U.S. Provisional Application No. 62/589,613, filed on Nov. 22, 2017, U.S. Provisional Application No. 62/606,993, filed on Oct. 16, 2017, and U.S. Provisional Application No. 62/573,006, filed on Oct. 16, 2017. All of the above-mentioned patents and applications are hereby incorporated by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62653247 | Apr 2018 | US | |
| 62589613 | Nov 2017 | US | |
| 62606993 | Oct 2017 | US | |
| 62573006 | Oct 2017 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15953151 | Apr 2018 | US |
| Child | 16205632 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17572206 | Jan 2022 | US |
| Child | 18112093 | US | |
| Parent | 17450978 | Oct 2021 | US |
| Child | 17572206 | US | |
| Parent | 16205632 | Nov 2018 | US |
| Child | 17127521 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 18112093 | Feb 2023 | US |
| Child | 18741038 | US | |
| Parent | 17127521 | Dec 2020 | US |
| Child | 17450978 | US |
