Patent Application
20230240873
The present disclosure relates generally to an outer sheath and the use of the outer sheath with a drug coated balloon for the treatment of vascular conditions. In particular, the present disclosure provides an outer sheath that is capable of covering the expandable member during delivery and removal of the drug coated balloon.
Angioplasty, also known as balloon angioplasty and percutaneous transluminal angioplasty, is a minimally invasive, endovascular procedure to widen narrowed or obstructed arteries or veins, typically to treat arterial atherosclerosis. A balloon catheter having a catheter shaft and an expandable member (i.e., balloon) is used to perform an angioplasty procedure. A physician uses medical imaging to guide the balloon portion of the catheter to the narrowing or obstruction in the vasculature. The balloon is inflated to open the vasculature and improve blood flow. Angioplasty may be done with or without a metal mesh tube called a stent, which if used is left inside the vasculature to assist in keeping the narrowing or obstruction open.
Angioplasty procedures can be used to treat peripheral vascular disease and coronary arterial disease. Peripheral vascular disease refers to diseased blood vessels in a subject's vascular system away from the subject's heart and brain. Although peripheral vascular disease can occur within a subject's arteries (arterial system) or veins (venous system), peripheral vascular disease typically occurs in a subject's arterial system and often in the legs.
Drug-Coated Balloon (DCB) angioplasty is similar to a conventional angioplasty procedure, but there is the addition of an anti-proliferative medication coating on the balloon, as well as an excipient to aid in drug transfer, which may help prevent restenosis. Restenosis is the re-narrowing of the vasculature at a site that was previously treated. Using a drug-coated balloon has the potential to prohibit cell division, limiting the amount of restenosis, or blockage re-growth after treatment.
The balloons of known DCB catheters are delivered to the vascular site in an uncovered state. And if covered during delivery to the vascular site, the balloon is uncovered during removal. When uncovered during either delivery or removal, some of the drug coating on the balloon may be lost and shed downstream within the vasculature. What is needed, therefore, is a device that can cover the balloon of a DCB catheter during delivery to and removal from the vascular site so as to prevent or reduce drug loss from the balloon.
The present disclosure discloses an outer sheath that can cover the balloon of a DCB catheter both during delivery to and removal from the vascular site so as to prevent or reduce drug loss from the balloon.
In accordance with a representative embodiment, a method for treating a restriction within a subject's vascular system of the present disclosure comprises: locating a restriction in the vascular system of the subject; positioning a sheath and a balloon catheter within the vascular system of the subject approximate the restriction, wherein the balloon catheter comprises a shaft and an expandable member, wherein the sheath comprises a distal portion and a distal end and an orifice at the distal end and a lumen extending proximally from the orifice, wherein the orifice has a first diameter; positioning the expandable member distally of the distal end of the sheath and adjacent the restriction within the vascular system; expanding the expandable member adjacent the restriction; deflating the expandable member; radially enlarging the orifice at the distal end of the sheath to a second diameter, wherein the second diameter is greater than the first diameter; inserting the expandable member into the distal end of the sheath while the orifice has the second diameter; and radially reducing the orifice at the distal end of the sheath.
In accordance with another representative embodiment, the expandable member comprises a length, wherein the distal portion of the sheath comprises a predetermined length, whereupon inserting the expandable member into the distal end of the sheath, the length of expandable member is disposed within the lumen of the sheath.
In accordance with another representative embodiment, the distal portion of the sheath comprises a predetermined length, whereupon inserting the expandable member into the distal end of the sheath, the length of expandable member is disposed within the predetermined length of the distal portion of the sheath.
In accordance with another representative embodiment, the predetermined length of the sheath is greater than the length of expandable member.
In accordance with another representative embodiment, the radially reducing the orifice at the distal end of the sheath comprises radially reducing the orifice at the distal end of the sheath to a third diameter.
In accordance with another representative embodiment, the third diameter is less than the second diameter.
In accordance with another representative embodiment, the third diameter is substantially the same as the first diameter.
In accordance with another representative embodiment, the method further comprises the step of simultaneously removing the sheath and balloon catheter from the vascular system of the subject.
In accordance with another representative embodiment, a catheter system comprises: a balloon catheter comprising an expandable member; a sheath comprising a distal portion having a distal end, wherein the distal end comprise an orifice having a diameter, wherein the distal portion comprises a lumen extending proximally from the orifice, and a means for increasing and decreasing the diameter of the orifice.
In accordance with another representative embodiment, the catheter system further comprises means for increasing and decreasing the diameter of the orifice comprises a plurality of wires radially disposed within the distal portion of the outer sheath and evenly spaced around a circumference of the distal portion of the outer sheath and extending proximally.
In accordance with another representative embodiment, the outer sheath comprises a handle, wherein the wires are coupled to the handle, and whereupon activating the handle, tension is applied to the wires, and the diameter of the orifice increases.
In accordance with another representative embodiment, when the handle is deactivated, tension is reduced to the wires, and the diameter of the orifice decreases.
In accordance with another representative embodiment, the plurality of wires each comprises a shape-memory metal configured to cause the increasing and decreasing of the diameter of the orifice.
In accordance with a representative embodiment, an apparatus comprises a sheath having a distal portion comprising a distal end. The distal end comprises a first orifice having a first diameter. The sheath comprises an electroactive polymer (EAP), which when actuated, increases the first diameter of the first orifice.
In accordance with another representative embodiment, the sheath has a proximal portion comprising a proximal end, and the proximal end comprises a second orifice having a second diameter. When actuated, the EAP causes no increase or decrease in the second diameter.
In accordance with another representative embodiment, the sheath when actuated has a flared profiled between the first orifice and the second orifice.
In accordance with another representative embodiment the EAP is an ionic EAP.
In accordance with another representative embodiment, the EAP is a field-driven EAP.
The preceding is a summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.
The embodiments are best understood from the following detailed description when read with the accompanying drawing figures. It is emphasized that the various features are not necessarily drawn to scale. In fact, the dimensions may be arbitrarily increased or decreased for clarity of discussion. Wherever applicable and practical, like reference numerals refer to like elements.
The present teachings relates generally to medical devices for the treatment of vascular conditions. In particular, the present disclosure provides apparatuses, methods and materials for providing an outer sheath that is capable of adapted to cover the expandable member during delivery and removal of the drug coated balloon. However, and importantly, the while various embodiments are described in connection with the insertion, expansion, retraction and withdrawal of balloon catheters, the present teachings are not limited to these applications. Rather, an apparatus comprising a sheath in which an opening or expansion of an orifice is effected is contemplated by the present teachings. For example, an apparatus according to the present teachings may be used in connection with stent retrievers for blood clot removal where opening and closing of the tip (distal portion/distal end) is beneficial for pulling the clot back into the sheath. Additionally, an apparatus according to the present teachings may be used in connection with pulling back embolic protection devices. Furthermore, an apparatus according to the present teachings may be used in connection with opening a tip of laser catheter to allow the laser to open a larger lumen.
In the following detailed description, for the purposes of explanation and not limitation, representative embodiments disclosing specific details are set forth in order to provide a thorough understanding of an embodiment according to the present teachings. Descriptions of known systems, devices, materials, methods of operation and methods of manufacture may be omitted so as to avoid obscuring the description of the representative embodiments. Nonetheless, systems, devices, materials and methods that are within the purview of one of ordinary skill in the art are within the scope of the present teachings and may be used in accordance with the representative embodiments. It is to be understood that the terminology used herein is for purposes of describing particular embodiments only and is not intended to be limiting. The defined terms are in addition to the technical and scientific meanings of the defined terms as commonly understood and accepted in the technical field of the present teachings.
It will be understood that, although the terms first, second, third etc. may be used herein to describe various elements or components, these elements or components should not be limited by these terms. These terms are only used to distinguish one element or component from another element or component. Thus, a first element or component discussed below could be termed a second element or component without departing from the teachings of the inventive concept.
The terminology used herein is for purposes of describing particular embodiments only and is not intended to be limiting. As used in the specification and appended claims, the singular forms of terms ‘a’, ‘an’ and ‘the’ are intended to include both singular and plural forms, unless the context clearly dictates otherwise. Additionally, the terms “comprises”, and/or “comprising,” and/or similar terms when used in this specification, specify the presence of stated features, elements, and/or components, but do not preclude the presence or addition of one or more other features, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items.
Unless otherwise noted, when an element or component is said to be “coupled to”, or “adjacent to” another element or component, it will be understood that the element or component can be directly connected or coupled to the other element or component, or intervening elements or components may be present. That is, these and similar terms encompass cases where one or more intermediate elements or components may be employed to connect two elements or components. However, when an element or component is said to be “directly connected” to another element or component, this encompasses only cases where the two elements or components are connected to each other without any intermediate or intervening elements or components.
For purposes of explanation and not limitation, various representative embodiments disclosing specific details are set forth in order to provide a thorough understanding of the present teachings. Other embodiments may be utilized and derived from the disclosure, such that structural and logical substitutions and changes may be made without departing from the scope of the present drawings. Additionally, as noted above, the drawings are merely representational and may not be drawn to scale. Certain proportions within the illustrations may be exaggerated, while other proportions may be minimized. Accordingly, the disclosure and the figures are to be regarded as illustrative rather than restrictive.
As used herein, “at least one,” “one or more,” and “and/or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C,” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as X1-Xn, Y1-Ym, and Z1-Zo, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (for example, X1 and X2) as well as a combination of elements selected from two or more classes (for example, Y1 and Zo).
The terms “about” or “approximately” when used in conjunction with a numeric value shall mean plus and/or minus ten percent (10%) of that numeric value, unless otherwise specifically mentioned herein.
The term “catheter” as used herein generally refers to a tube that can be inserted into a body cavity, duct, lumen, or vessel, such as the vasculature system. In most uses, a catheter is a relatively thin, flexible tube (“soft” catheter), though in some uses, it may be a larger, solid, less flexible—but possibly still flexible—catheter (“hard” catheter). In some uses a catheter may contain a lumen along part or all of its length to allow the introduction of other catheters or guidewires. An example of a catheter is a sheath.
The term “balloon catheter” as used herein generally refers to the various types of catheters which carry a balloon for containing fluids. Balloon catheters may also be of a wide variety of inner structure, such as different lumen design, of which there are at least three basic types: triple lumen, dual lumen and co-axial lumen. All varieties of internal structure and design variation are meant to be included by use of the term “balloon catheter” herein. In some uses, balloon catheters can be used to perform angioplasty.
The term “means” as used herein shall be given its broadest possible interpretation in accordance with 35 U.S.C. § 112(f). Accordingly, a claim incorporating the term “means” shall cover all structures, materials, or acts set forth herein, and all of the equivalents thereof. Further, the structures, materials or acts and the equivalents thereof shall include all those described in the summary, brief description of the drawings, detailed description, abstract, and claims themselves.
The term “sheath” as used herein generally refers to a tube that can be inserted into a body cavity duct, lumen, or vessel, such as the vasculature system that allows for the introduction of other devices, such as catheters, and the introduction of fluid along its length. The sheath can have a closed end or an open end. Because the sheath is a tube that can be inserted into a body cavity, duct, lumen, or vessel, such as the vasculature system, the sheath may also be considered a catheter.
The term “therapeutic agent” as used herein generally refers to any known or hereafter discovered pharmacologically active agent that provides therapy to a subject through the alleviation of one or more of the subject's physiological symptoms. A therapeutic agent may be a compound that occurs in nature, a chemically modified naturally occurring compound, or a compound that is chemically synthesized. The agent will typically be chosen from the generally recognized classes of pharmacologically active agents, including, but not necessarily limited to, the following: analgesic agents; anesthetic agents; antiarthritic agents; respiratory drugs, including antiasthmatic agents; anticancer agents, including antineoplastic drugs; anticholinergics; anticonvulsants; antidepressants; antidiabetic agents; antidiarrheals;
antihelminthics; antihistamines; antihyperlipidemic agents; antihypertensive agents; anti-infective agents such as antibiotics and antiviral agents; antiinflammatory agents; antimigraine preparations; antinauseants; antiparkinsonism drugs; antipruritics; antipsychotics; antipyretics; antispasmodics; antitubercular agents; antiulcer agents; antiviral agents; anxiolytics; appetite suppressants; attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD) drugs; cardiovascular preparations including calcium channel blockers, CNS agents; beta-blockers and antiarrhythmic agents; central nervous system stimulants; cough and cold preparations, including decongestants; diuretics; genetic materials; herbal remedies; hormonolytics; hypnotics; hypoglycemic agents; immunosuppressive agents; leukotriene inhibitors; mitotic inhibitors; restenosis inhibitors; muscle relaxants; narcotic antagonists; nicotine; nutritional agents, such as vitamins, essential amino acids and fatty acids; ophthalmic drugs such as antiglaucoma agents; parasympatholytics; psychostimulants; sedatives; steroids; sympathomimetics; tranquilizers; and vasodilators including general coronary, peripheral and cerebral.
The terms “vasculature” and “vascular” as used herein refer to any part of the circulatory system of a subject, including peripheral and non-peripheral arteries and veins. Vasculature can be comprised of materials such as nucleic acids, amino acids, carbohydrates, polysaccharides, lipids fibrous tissue, calcium deposits, remnants of dead cells, cellular debris and the like.
The term “vascular occlusion” or “occlusion” refers to buildup of fats, lipids, fibrin, fibro-calcific plaque, thrombus and other atherosclerotic tissue within the lumen or within the intima of an artery that either narrows or completely obstructs the inner lumen the artery thereby restricting or blocking normal blood flow through the artery segment. The occlusion may partially or totally occlude the vasculature. Accordingly, the term “vascular occlusion” or “occlusion” shall include both a total occlusion and a partial occlusion. Alternatively, a vascular occlusion or occlusion may also be referred to as a vascular obstruction (or obstruction) or a vascular restriction (or restriction). A vascular obstruction may, therefore, be referred to as a total obstruction or a partial obstruction, and a vascular restriction may be referred to as a total restriction or a partial restriction.
It should be understood that every maximum numerical limitation given throughout this disclosure is deemed to include each and every lower numerical limitation as an alternative, as if such lower numerical limitations were expressly written herein. Every minimum numerical limitation given throughout this disclosure is deemed to include each and every higher numerical limitation as an alternative, as if such higher numerical limitations were expressly written herein. Every numerical range given throughout this disclosure is deemed to include each and every narrower numerical range that falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.
Referring to
During manufacturing or packaging, after the drug or therapeutic is applied to the DCB 110, the DCB 110 is spirally wound and/or folded in a collapsed state and inserted into the outer sheath 115 so that the DCB 110 is completely covered by the outer sheath 115. Because the insertion of the DCB 110 into the outer sheath 115 during manufacturing, which is a controlled environment, the diameter of the collapsed DCB 110 is able to be reduced to a size smaller than the orifice and lumen of the outer sheath 115.
Referring to
Referring to
To accommodate for the enlarged deflated diameter of the DCB 110 (in comparison to the originally (packaging) deflated diameter of the DCB 110 prior to inflation) it may be desirable to increase the size of the diameter of the orifice of the distal end of the outer sheath 115 and the lumen of the distal portion end of the outer sheath 115. Referring to
Referring to
As shown in
Again,
Continuing to refer to
Actuating the plurality of wires 140 using a handle is a viable way to cause the diameter of the orifice 155, as well as the lumen at the distal portion of the outer sheath 115 to increase over the predetermined distance (A). Alternatively, and instead of manual actuation of the wires using the referenced handle, the present teachings contemplate effecting the change in diameter over the predetermined distance (A) using a shape-memory metal. In accordance with a representative embodiment, each of the plurality of wires comprises an alloy of Nickel and Titanium having the trade name Nitinol®. As is known, Nitonol° is deformed at a comparatively low temperature, and returns to its original shape when heated through the shape memory effect. Notably, the outer sheath 115 is contemplated to have an inner layer that is includes shape-memory metal that expands, and an outer layer that covers the inner layer. As such, when the outer layer is pulled back, the inner layer expands.
Referring to
Alternatively, the EAP may be a field driven EAP. Such polymers are described for example in commonly owned U.S. Patent Application Publication No. 20200168783, the disclosure of which is specifically incorporated herein by reference.
Actuation of the layer of ionic EAP 401 is effected by application of a voltage difference between the first and second electrodes, as shown in
Referring to
Referring to
Referring to
A first electrode 607 and a second electrode 608 are disposed along an outer portion of the shaft 606, and extend along its length to make contact with the unactuated sheath 601.
Referring to
Referring to
After positioning the outer sheath and the balloon catheter approximate the restriction, the expandable member is extended distally of the distal end of the outer sheath and is positioned adjacent the restriction in step 720. Next, the expandable member is expanded adjacent the restriction in step 725. It is preferable that the expandable member is a DCB. So, after the DCB is inflated for a predetermined period of time to reduce the size of the restriction and introduce the therapeutic agent to the remainder of the restriction, the expandable member is deflated in step 730.
Next, in step 735, the orifice at the distal end of the outer sheath is increased in size to a second diameter, wherein the second diameter is greater than the first diameter, in order to accommodate the increased size of the deflated inflatable member after the inflatable member has been inflated and deflated. While the size of the orifice and the distal portion of the outer sheath are increased to a diameter equal to or greater than the size of the deflated inflatable member, the expandable member is inserted through the orifice and into the distal end of the sheath in step 740. After the expandable member is in the distal end of the outer sheath, the orifice at the distal end of the outer sheath is radially reduced in size and both the outer sheath and balloon catheter are simultaneously removed from the vasculature in step 745.
The present disclosure, in various aspects, embodiments, and configurations, includes components, methods, processes, systems and/or apparatus substantially as depicted and described herein, including various aspects, embodiments, configurations, sub combinations, and subsets thereof Those of skill in the art will understand how to make and use the various aspects, aspects, embodiments, and configurations, after understanding the present disclosure. The present disclosure, in various aspects, embodiments, and configurations, includes providing devices and processes in the absence of items not depicted and/or described herein or in various aspects, embodiments, and configurations hereof, including in the absence of such items as may have been used in previous devices or processes, for example, for improving performance, achieving ease and\or reducing cost of implementation.
The foregoing discussion of the disclosure has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description for example, various features of the disclosure are grouped together in one or more, aspects, embodiments, and configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and configurations of the disclosure may be combined in alternate aspects, embodiments, and configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claimed disclosure requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspects, embodiments, and configurations. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.
Moreover, though the description of the disclosure has included description of one or more aspects, embodiments, or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, for example, as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and configurations to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.
The present application claims priority under 35 U.S.C. § 119(e) and under 37 C.F.R. § 1.78(a) to commonly owned U.S. Provisional Application No. 62/951,311 filed on Dec. 20, 2019. The entire disclosure of U.S. Provisional Application No. 62/951,311 is specifically incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2020/087357 | 12/21/2020 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62951311 | Dec 2019 | US |
