Patent Application
20230068326
All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
This application relates to various methods and devices for at least partially occluding peripheral blood flow from a blood vessel while maintaining perfusion to blood vessels and structures distal to the occlusion site. Additionally, the occlusion devices may also enable a single vascular access point for simultaneous use of a therapeutic device in conjunction with use of the occlusion device. Still further, embodiments of the present invention relates generally to medical interventions conducted through vessels of the vasculature such as the major arteries, veins and more particularly to access and deployment configurations for conducting percutaneous procedures such as percutaneous valve replacement wherein an introducer sheath combined with a protective device may be utilized to provide minimally-invasive vascular access for passing instruments, prostheses, and other structures along with protection or reduction of harm to exposure to imaging contrast agents used during the above mentioned procedures.
Contrast Induced Acute kidney injury (CI-AKI), also called acute renal failure (ARF), is a rapid loss of kidney function. Its causes are numerous and include low blood volume from any cause, exposure to substances harmful to the kidney, and obstruction of the urinary tract. CI-AKI is diagnosed on the basis of characteristic laboratory findings, such as elevated blood creatinine, or inability of the kidneys to produce sufficient amounts of urine.
Contrast Induced Acute Kidney Injury is diagnosed on the basis of clinical history and laboratory data. A diagnosis is made when there is rapid reduction in kidney function, as measured by serum creatinine, or based on a rapid reduction in urine output, termed oliguria.
For example, the use of intravascular iodinated contrast agents may cause acute kidney injury. In patients receiving intravascular iodine-containing contrast media for angiography, contrast-induced AKI (CI-AKI) is a common problem and is associated with excessive hospitalization cost, morbidity, and mortality. Clinical procedures involving intravascular iodine-containing contrast media injection include for example, percutaneous coronary intervention (PCI), peripheral vascular angiography and intervention, neurological angiography and intervention. Solutions have been suggested for occluding at least partially the blood flow into the renal arteries during procedures where a patient is exposed to intravascular contrast.
Gaining access to the heart and other parts of the cardiovascular anatomy is a continued challenge in cardiovascular medicine. For example, conventional open-surgical procedures for accomplishing tasks such as valve replacement generally involve a thoracotomy and/or creation of one or more access ports across the wall of the heart itself, which is relatively highly invasive and therefore undesirable. Recent progress has been made in the area of catheter-based percutaneous intervention, wherein instrumentation, such as catheters, guidewires, and prostheses, are brought to the heart, brain, or other tissue structures associated with the cardiovascular system through the vessels connected to such structures. These vascular pathways may be quite tortuous and geometrically small, and thus one of the challenges with percutaneous procedures lies in gaining access, conducting the desired interventional and/or diagnostic procedures, and removing the pertinent instrumentation, without damaging the vasculature or associated anatomy.
Conventionally with percutaneous procedures, introducer and dilator sets have been utilized to provide a usable access conduit through an arteriotomy or other surgical access to the vasculature. For procedures on large, relatively straight, and relatively undiseased vessels, such configurations may be adequate, but frequently cardiovascular diagnostic and/or interventional procedures are conducted on diseased cardiovascular systems and in tortuous anatomy. There is a need for better access tools and procedures, which may be utilized to establish vascular access in a relatively efficient geometric package (i.e., in a collapsed state), be expanded in situ as necessary to pass instrumentation, prostheses, or other structures (for example, the un-expanded delivery size of a commercially available aortic valve prosthesis may be up to 18 French or more such as other valves having an un-expanded delivery size of a between 18 and 24 French, depending upon which size is utilized) and to be re-collapsed before or during withdrawal so that the associated anatomy is not undesirably loaded or damaged during such withdrawal. Moreover, the increased availability of such devices and the accompanying use of imaging contrast agents to assist in their proper implantation is leading to an increased risk of patient over exposure to contrast. As such, there remains a need for improvements in introducer sheaths as well as in protection for damage to collateral structures such as the kidneys from exposure to imaging contrast or other agents.
There is also a continuing need for reducing complexity in coordination of device use in vascular procedures. Additionally, it is clinically desirous to reduce where possible the number of access points into the patient's vasculature.
While some solutions have been proposed for vascular occlusion and access, the need for improved methods and especially combination devices remain.
In general, in one embodiment, a vascular occlusion device includes a handle having a first part and a second part, an inner shaft coupled to the handle first part, an outer shaft over the inner shaft and coupled to the handle second part, a scaffold structure having a distal end, a scaffold transition zone and a proximal end having one or a plurality of legs wherein the one leg or each leg of the plurality legs is coupled to a distal portion of the inner shaft, wherein the scaffold structure moves from a stowed configuration when the outer shaft is extended over the scaffold structure and a deployed configuration when the outer shaft is retracted from covering the scaffold structure by relative movement of the handle first part and the handle second part; and a scaffold covering over at least a portion of the scaffold structure, the multiple layer scaffold covering having a distal scaffold attachment zone where a portion of the scaffold covering is attached to a distal portion of the scaffold, a proximal scaffold attachment zone where a portion of the scaffold covering is attached to a proximal portion of the scaffold and an unattached zone between the distal attachment zone and the proximal attachment zone wherein the scaffold covering is unattached to an adjacent portion of the scaffold.
This and other embodiments can include one or more of the following features. The plurality of legs can be two legs, three legs or four legs. The scaffold covering can extend from the distal end of the scaffold structure to the one leg or to each of the two legs, three legs or the four legs. The scaffold covering can extend from the distal end of the scaffold structure proximally to cover approximately 20%, 50%, 80% or 100% of the overall length of the scaffold structure. The scaffold covering can extend completely circumferentially about the scaffold structure from the distal attachment zone to the proximal attachment zone. The vascular occlusion device can further include one or more pressure relief features within the scaffold covering. The one or more pressure relief features can be a slit or an opening in the scaffold covering. A distal end portion of the outer sheath can further include an expansion zone. The expansion zone of the outer sheath can include a plurality of sections joined by one or more flexible couplings. Each section of the plurality of sections can include two or three segments. When outer sheath is advanced over the scaffold structure in a deployed configuration, the expansion zone of the outer sheath can transition into a larger diameter to accommodate the scaffold structure of the perfusion device. A distal end portion of the outer sheath can further include an expansion zone having one or a combination of slits, zig-zag cuts, braids or expansion features.
In general, in one embodiment, a combination vascular occlusion and vascular access device includes a handle, an inner shaft coupled to the handle, the inner shaft having a lumen accessible via a hemostasis valve in the handle, an outer shaft over the inner shaft and coupled to the handle, an occlusion with perfusion device having a scaffold structure coupled to the inner shaft, and a scaffold covering over at least a portion of the scaffold structure, the scaffold covering having a distal scaffold attachment zone where a portion of the scaffold covering is attached to a distal portion of the scaffold, a proximal scaffold attachment zone where a portion of the scaffold covering is attached to a proximal portion of the scaffold and an unattached zone between the distal attachment zone and the proximal attachment zone wherein the scaffold covering is unattached to an adjacent portion of the scaffold, and a dilator having an occlusion device pocket proximal to a distal end of the dilator, the occlusion device pocket is sized to hold the occlusion with perfusion device.
This and other embodiments can include one or more of the following features. The occlusion device pocket can be formed by dilator shaft that joins the dilator tip to the dilator body. The length of the occlusion device pocket can be 5 cm, 10 cm, 20 cm or 40 cm. The occlusion device pocket can have a recessed outer diameter of about 0.035 inches or from 0.035 to 0.050 inches and a recessed portion inner diameter of about 0.021 inches or from 0.021 inches to 0.040 inches. The length of the occlusion device pocket can be sufficient to hold an occlusion device having a therapeutic length 1, a therapeutic length 2 or a therapeutic length 3. The scaffold structure having a distal end, a scaffold transition zone and a proximal end having one or a plurality of legs wherein the one leg or each leg of the plurality legs can be coupled to a distal portion of the inner shaft, wherein the scaffold structure can move from a stowed configuration when the outer shaft is extended over the scaffold structure and a deployed configuration when the outer shaft is retracted from covering the scaffold structure. The lumen of the inner shaft sized to allow access for a guide catheter adapted for passing an intravascular device that is one of a diagnostic instrument, or an instrument selected from the group consisting of: an angiography catheter, an intravascular ultrasound testing instrument, or an intravascular optical coherence tomography instrument, and the therapeutic instrument can be preferably a balloon catheter, a drug-eluting balloon catheter, a bare metal stent, a drug-eluting stent, a drug-eluting biodegradable stent, a rotablator, a thrombus suction catheter, a drug administration catheter, a guiding catheter, a support catheter, or a device or a prosthesis delivered as part of a TAVR, TMVR, or TTVR procedure or system. The scaffold covering can extend partially circumferentially about the scaffold structure from the distal attachment zone to the proximal attachment zone with an uncovered scaffold structure. The scaffold covering can extend partially circumferentially about 270 degrees of the scaffold structure from the distal attachment zone to the proximal attachment zone. A first scaffold covering can extend partially circumferentially about 45 degrees of the scaffold structure from the distal attachment zone to the proximal attachment zone and a second scaffold covering extends partially circumferentially about 45 degrees of the scaffold structure from the distal attachment zone to the proximal attachment zone, wherein the first scaffold covering and the second scaffold covering can be on opposite sides of the longitudinal axis of the scaffold structure. The scaffold structure can be formed from slots cut into a tube. Scaffold covering can be formed from multiple layers. The layers of the multiple layer scaffold covering can be selected from ePFTE, PTFE, FEP, polyurethane or silicone. The scaffold covering or the more than one layers of a multiple layer scaffold covering can be applied to a scaffold structure external surface, to a scaffold structure internal surface, to encapsulate the distal scaffold attachment zone and the proximal scaffold attachment zone, as a series of spray coats, dip coats or electron spin coatings to the scaffold structure. The multiple layer scaffold covering can have a thickness of 5-100 microns. The multiple layer scaffold covering can have a thickness of about 0.001 inches in an unattached zone and a thickness of about 0.002 inches in an attached zone.
In general, in one embodiment, a method of providing selective occlusion with distal perfusion using a vascular occlusion device includes advancing the vascular occlusion device in a stowed condition along a blood vessel to a position adjacent to one or more peripheral blood vessels in the portion of the vasculature of the patient selected for occlusion while the vascular occlusion device is tethered to a handle outside of the patient, transitioning the vascular occlusion device from the stowed condition to a deployed condition using the handle wherein the vascular occlusion device at least partially occludes blood flow into the one or more peripheral blood vessels selected for occlusion wherein the position of the vascular occlusion device engages with a superior aspect of the vasculature to direct blood flow into and along a lumen defined by a covered scaffold structure of the vascular occlusion device, deflecting a portion of an unattached zone of the covered scaffold in response to the blood flow through the lumen of the covered scaffold into an adjacent opening of the one or more peripheral blood vessels in the portion of the vasculature of the patient selected for occlusion, transitioning the vascular occlusion device from the deployed condition to the stowed condition using the handle; and withdrawing the vascular occlusion device in the stowed condition from the patient.
This and other embodiments can include one or more of the following features. The one or more peripheral blood vessels in the portion of the vasculature of the patient selected for occlusion can be selected from the group consisting of a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery. The covered scaffold unattached zone can further include a position of a portion of the unattached zone to deflect into a portion of at least one of a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery when the vascular occlusion device is positioned within a portion of the aorta.
In general, in one embodiment, a method of temporarily occluding a blood vessel, includes advancing a vascular occlusion device in a stowed condition along a blood vessel to a position adjacent to one or more peripheral blood vessels selected for temporary occlusion, transitioning the vascular occlusion device from the stowed condition to a deployed condition wherein the vascular occlusion at least partially occludes blood flow into the one or more peripheral blood vessels selected for temporary occlusion while directing the blood flow through and along a lumen of a covered scaffold of the vascular occlusion device, and transitioning the vascular occlusion device out of the deployed condition to restore blood flow into the one or more peripheral blood vessels selected for temporary occlusion when a period of temporary occlusion is elapsed.
This and other embodiments can include one or more of the following features. Directing the blood flow through and along the lumen of the vascular occlusion device can maintain blood flow to components and vessels distal to the vascular occlusion device while at least partially occluding the blood flow to the one or more peripheral blood vessels. The one or more peripheral blood vessels can be the vasculature of a liver, a kidney, a stomach, a spleen, an intestine, a stomach, an esophagus, or a gonad. The blood vessel can be an aorta and the peripheral blood vessels can be one or more or a combination of: a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery.
In general, in one embodiment, a method of providing vascular access and reversibly and temporarily occluding a blood vessel includes advancing an at least partially covered scaffold structure of a tethered vascular occlusion device to a portion of an aorta to be occluded, using a handle of the vascular occlusion device to deploy the at least partially covered scaffold structure within the aorta to occlude partially or completely one or more or a combination of: a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery using a portion of a multiple layer scaffold covering while simultaneously allowing perfusion flow through a lumen of the at least partially covered scaffold structure to distal vessels and structures, and using the handle to transition the at least partially covered scaffold structure to a stowed condition between an inner wall of an introducer sheath and an outer wall of a guide catheter within the vascular occlusion device.
This and other embodiments can include one or more of the following features. The insertion of the vascular occlusion device or of the at least partially covered scaffold device to a blood vessel which is the aorta can be introduced by transfemoral artery approach or by trans-brachial artery approach or by trans-radial artery approach. The method can further include advancing the vascular occlusion device over a guidewire into a position adjacent to a landmark of the skeletal anatomy.
In general, in one embodiment, a method of providing vascular occlusion with distal perfusion during an interventional vascular procedure includes accessing an artery of the arterial vasculature with an introducer sheath having an outer wall and an inner wall and a central lumen which is concentric and coaxial with an occlusion with perfusion device in a stowed condition against the introducer sheath inner wall, advancing the introducer sheath with the stowed occlusion with perfusion device into an occlusion position within an aorta with the occlusion with perfusion device adjacent to one or more branch vessels and a distal end of the introducer sheath superior to the one or more branch vessels, withdrawing the introducer sheath to transition the occlusion with perfusion device into a deployed condition within the aorta and in position to reversibly occlude the one or more branch vessels, advancing a guide catheter through a lumen of a shaft of the occlusion with perfusion device, accessing the vasculature with an interventional therapy device via the guide catheter, and performing a catheter based therapy at a vascular access therapy site more than 2 cm distal to the occlusion with perfusion device.
This and other embodiments can include one or more of the following features. The method can further include transitioning the occlusion with perfusion device to a stowed configuration between the inner wall of the introducer sheath and an outer wall of the guide catheter. The method can further include withdrawing a dilator from the lumen of the occlusion with perfusion shaft before performing the step of advancing a guide catheter through a lumen of a shaft of the occlusion with perfusion device. During the step of withdrawing the introducer sheath to transition the occlusion with perfusion device into a deployed condition, the occlusion with perfusion device can move out of contact with an occlusion device pocket of a dilator within the lumen of the shaft of the occlusion with perfusion device. The method can further include transitioning the occlusion with perfusion device to a deployed condition to temporarily and reversibly occlude the one or more branch vessels before performing a step of injecting a contrast solution in support of the catheter based therapy performed using access from the guide catheter in the occlusion with perfusion device. The catheter based therapy site can be at least 8 cm, 10 cm, 20 cm or more distal to the one or more renal ostia. The method can further include transitioning the occlusion with perfusion device from the stowed condition in contact with the outer wall of the guide catheter into a position to at least partially occlude at least one ostia of a renal artery and back to the stowed condition at least once during the step of performing a catheter based therapy. The catheter based therapy site can be at least 8 cm, 10 cm, 20 cm or more distal to the one or more renal ostia. The catheter based therapy site can be at least 8 cm, 10 cm, 20 cm or more distal to the location of the occlusion with perfusion device. The catheter based therapy device can be a prosthetic heart valve or component used as part of a TAVR, TMVR or TTVR procedure or system. The outer diameter of the introducer sheath can be from 7 Fr to 21 Fr. After performing the catheter based therapy, the catheter based therapy device can have a diameter of 15-31 mm. The step of performing a catheter based therapy can further include injecting an amount of contrast agent into the vasculature of the patient. The method can further include transitioning the occlusion with perfusion device from the stowed condition into a position to at least partially occlude at least one ostia of a renal artery for a contrast protection time period and when the contract protection time period has elapsed transitioning the occlusion with perfusion device back to the stowed condition. After the completing of the performing a catheter based therapy and withdrawing all instruments used in the therapy, withdrawing the introducer and occlusion with perfusion device from the artery. The step of transitioning the occlusion with perfusion device between stowed and the position to at least partially occlude one or more ostia of the renal arteries can be performed without adjusting position or introducer or interfering with the working channel used for the distal cardiovascular procedure.
In general, in one embodiment, a vascular occlusion device includes a handle having a slider knob, an inner shaft coupled to the handle, an outer shaft over the inner shaft and coupled within the handle to the slider knob, a scaffold structure having at least two legs and a multiple layer scaffold covering, the at least two legs of the scaffold structure attached to an inner shaft coupler in a distal portion of the inner shaft, and the multiple layer scaffold covering positioned over at least a portion of the scaffold structure. The scaffold structure moves from a stowed condition when the outer shaft is extended over the scaffold structure and a deployed condition when the outer shaft is retracted from covering the scaffold structure.
This and other embodiments can include one or more of the following features. The scaffold structure can be formed from slots cut into a tube. The covering can be applied to nearly all, 80%, 70%, 60%, 50%, 30% or 20% of the scaffold structure. The multiple layer scaffold covering can be made of ePFTE, PTFE, polyurethane, FEP or silicone. The multiple layer scaffold covering can be folded over a proximal portion and a distal portion of the scaffold. After the multiple layer scaffold covering is attached to the scaffold, the scaffold can further include a distal attachment zone, a proximal attachment zone and an unattached zone. The multiple layer scaffold covering can further include a proximal attachment zone, a distal attachment zone and an unattached zone wherein a thickness of the multiple layer covering in the proximal attachment zone and the distal attachment zone is greater than the thickness of the multiple layer scaffold covering in the unattached zone. The multiple layer scaffold covering on the scaffold structure can have a thickness of 5-100 microns. Scaffold structure can have a cylindrical portion and a conical portion wherein the terminal ends of the conical portion are coupled to the inner shaft. The inner shaft can further include one or more spiral cut sections to increase flexibility of the inner shaft. The one or more spiral cut sections can be positioned proximally or distally or both proximal and distal to an inner shaft coupler where the scaffold structure is attached to the inner shaft. The scaffold structure can further include two or more legs. Each of the two or more legs can terminate with a connection tab that is joined to a corresponding key feature on an inner shaft coupler. The multiple layer scaffold covering can include one or more or a pattern of apertures that are shaped, sized or positioned relative to the scaffold structure to modify the amount of distal perfusion provided by the vascular occlusion device in use within the vasculature. The multiple layer scaffold covering can include one or more regular or irregular geometric shapes arranged in a continuous or discontinuous pattern which is selected to adapt the distal perfusion flow profile of the vascular occlusion device in use within the vasculature. When in a stowed configuration within the outer shaft, the overall diameter can be between 0.100 inches and 0.104 inches and when in a deployed configuration the covered scaffold has an outer diameter from 19 to 35 mm. The covered scaffold can have an occlusive length of 40 mm to 100 mm measured from a distal end of the scaffold to a scaffold transition zone. An introducer with an occlusion and perfusion device can be adapted for or used to perform an intravascular procedure in a radial artery, an ulnar artery, a coronary artery, a posterior tibial artery, a fibular artery, an anterior tibial artery, a popliteal artery, a vein, a femoral artery or a portion of an aorta. An introducer with an occlusion and perfusion device can be adapted for or used to perform an intravascular procedure wherein the intravascular device is at least one of a diagnostic instrument, an angiography catheter, a balloon catheter, a drug-eluting balloon catheter, a bare metal stent, a drug-eluting stent, a drug-eluting biodegradable stent, an intravascular ultrasound testing instrument, a rotablator, a thrombus suction catheter, a drug administration catheter, a prosthesis for a portion of the vasculature, a prosthesis for a portion of an organ, a prosthesis for a portion of a heart, a prosthetic heart valve, or a device described in Appendix A or used in TMVR, TTVR, TAVR or other transcatheter coronary repair or replacement component, device, system of procedure. The introducer can further include an expansion capability along all or a portion of the length of the introducer wherein the expansion capability is provided by one or more of a selection of flexible biocompatible polymers alone or in any combination with a braided portion. A portion of an unattached zone of a multiple layer scaffold covering can distend in response to blood flow along a lumen of the scaffold of the vascular occlusion device to occlude an opening of any of a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery.
One embodiment is directed to a system for deploying a device to a distal location across a vessel, comprising an elongate introducer sheath and an occlusion with perfusion device stowed within the introducer sheath and proximal to the distal end of the sheath. The elongate introducer sheath tubing may be adapted and configured to expand or be expanded temporarily when capturing a deployed occlusion device, especially when a guide catheter is within the shaft of the occlusion device. Once stowed in this condition, the occlusion device is between an inner wall of the introducer sheath and an outer wall of the guide catheter. Additionally, the expandable section of the outer sheath may be distended when intravascular device is advanced along the lumen or working channel of the introducer.
Upon positioning the introducer into a desired position relative to the renal artery ostia or into a position where the occlusion with perfusion device is positioned to provide partial or substantially complete or complete occlusion of the renal artery ostia to prevent blood flow to the kidneys, the introducer may be configured to be expanded selectively or temporarily into an expanded configuration to facilitate passage of one or more relatively large diameter structures through the lumen of the occlusion with perfusion device that is within the outer sheath. In such a condition, the occlusion with perfusion device may be spaced apart from the outer wall of the introducer to allow for introducer expansion during transit of large diameter devices where the expanded condition of the introducer is beneficially employed. Upon completion of passage of the one or more relatively large diameter structures, the occlusion with perfusion device and/or the outer sheath may be configured to be collapsed back to the collapsed configuration and the occlusion with perfusion device return to the stowed condition to reduce the size of the introducer and occlusion device presented to the blood flow and lumen cross section.
One or both of the introducer or the occlusion with perfusion device may comprise one or more radio-opaque markers coupled to the sheath and configured to assist an operator observing fluoroscopy with positioning of the introducer and occlusion with perfusion device combination relative to the vessel. The introducer may be expandable partially, in sections or substantially expandable by incorporation of one or more of: an open-cell fibrous wall material having a matrix of fibers; a matrix of fibers in a braided pattern; fibers or layers of the introducer comprising a polymeric material selected from one or more of a combination of: polyester, polyamide, polypropylene, and copolymers thereof.
Some portion of the introducer and occlusion with perfusion device may be provided from a substantially non-porous expandable layer may comprise a flexible polymeric material selected from the group consisting of: silicone rubber, olefin block copolymers, and copolymers thereof. Embodiments of the combined introducer and occlusion with perfusion device may be employed to reduce exposure, substantially eliminate exposure or otherwise protect the patient from contrast damage or exposure during intravascular procedures performed using the working channel or lumen of the shaft connected to the occlusion with perfusion device within the introducer. Any of a number of different vascular procedures may be performed by the single point of access provided by the outer sheath and occlusion device combination, such as, for delivery of an implantable prosthesis selected to be passed through the sheath occlusion device combination to a distal location across the vessel or in a vascular procedure where the implantable prosthesis may comprise a cardiac valve prosthesis.
In one aspect provides a device for treating or reduce the risk of acute kidney injury or to provide temporary partial or total occlusion of a blood vessel, comprising: an at least partially covered scaffold on a distal portion of a catheter. The covering or membrane or coating on the scaffold structure provides a functional aspect similar to the disturbing means examples described herein which are associated with a balloon embodiment. In use, the at least partially covered scaffold structure may be positioned to allow some flow, occlude all flow or modulate between flow, no flow or partial flow conditions based on the position of the scaffold structure relative to the blood vessel interior wall.
In another aspect provides a temporary occlusion device for at least partially occluding some or all peripheral vessels from a blood vessel while allowing perfusion to distal vessels and structures. In use when the blood vessel is an aorta, the temporary occlusion device is a partially covered scaffold with an optional position indicator wherein the partially covered scaffold is deployed to occlude completely or partially one or more of a blood vessel in the aorta, the suprarenal aorta or the infrarenal aorta. In another aspect, the at least partially covered scaffold structure is deployed within an aorta to occlude partially or completely one or more or a combination of: a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery while simultaneously allowing perfusion flow through or around the at least partially covered scaffold structure to distal vessels and structures.
In some embodiments, the insertion of the at least partially covered scaffold device to an aorta is applied either by transfemoral artery approach or by trans-brachial artery approach or by trans-radial artery approach. In certain embodiments, the catheter further includes an inner shaft adapted for use with a guidewire. In certain embodiments, the method further comprises initially inserting a guidewire into a vessel leading to an aorta.
In general, in one embodiment, a vascular occlusion device includes a handle having a slider, an inner shaft coupled to the handle, an outer shaft over the inner shaft and coupled to the slider, a scaffold structure having a distal end, a scaffold transition zone and a proximal end having a plurality of legs wherein each leg of the plurality legs is coupled to a distal portion of the inner shaft. The scaffold structure moves from a stowed configuration when the outer shaft is extended over the scaffold structure and a deployed configuration when the outer shaft is retracted from covering the scaffold structure. There may be a multiple layer scaffold covering over at least a portion of the scaffold structure. The multiple layer scaffold covering has a distal scaffold attachment zone where a portion of the scaffold covering is attached to a distal portion of the scaffold, a proximal scaffold attachment zone where a portion of the scaffold covering is attached to a proximal portion of the scaffold. There is also an unattached zone between the distal attachment zone and the proximal attachment zone where the scaffold covering is unattached to an adjacent portion of the scaffold.
This and other embodiments include one or more of the following features. The plurality of legs can be two legs or three legs. The scaffold covering can extend from the distal end of the scaffold structure to each of the two legs or the three legs. The scaffold covering can extend from the distal end of the scaffold structure proximally to cover approximately 20%, 50%, 80% or 100% of the overall length of the scaffold structure. The scaffold covering can extend completely circumferentially about the scaffold structure from the distal attachment zone to the proximal attachment zone. The scaffold covering can extend partially circumferentially about the scaffold structure from the distal attachment zone to the proximal attachment zone with an uncovered scaffold structure. The scaffold covering can extend partially circumferentially about 270 degrees of the scaffold structure from the distal attachment zone to the proximal attachment zone. A first scaffold covering can extend partially circumferentially about 45 degrees of the scaffold structure from the distal attachment zone to the proximal attachment zone and a second scaffold covering can extend partially circumferentially about 45 degrees of the scaffold structure from the distal attachment zone to the proximal attachment zone. The first scaffold covering and the second scaffold covering can be on opposite sides of the longitudinal axis of the scaffold structure. The multiple layer scaffold covering can be attached to the scaffold in the distal scaffold attachment zone and in the proximal scaffold attachment zone by encapsulating a portion of the scaffold, by folding over a portion of the multiple layer scaffold covering and encapsulating a portion of the scaffold, by stitching the multiple layer scaffold covering to a portion of the scaffold, or by electrospinning the multiple layer scaffold to a portion of the scaffold. The scaffold structure can be formed from slots cut into a tube. The covering can be applied to nearly all, 80%, 70%, 60%, 50%, 30% or 20% of the scaffold structure. Scaffold covering can be formed from multiple layers. The layers of the multiple layer scaffold covering can be selected from ePFTE, PTFE, FEP, polyurethane or silicone. The scaffold covering or the more than one layers of a multiple layer scaffold covering can be applied to a scaffold structure external surface, to a scaffold structure internal surface, to encapsulate the distal scaffold attachment zone and the proximal scaffold attachment zone, as a series of spray coats, dip coats or electron spin coatings to the scaffold structure. The multiple layer scaffold covering can have a thickness of 5-100 microns. The multiple layer scaffold covering can have a thickness of about 0.001 inches in an unattached zone and a thickness of about 0.002 inches in an attached zone. The vascular occlusion can further include a double gear pinion within the handle that couples the outer shaft to the slider.
In general, in one embodiment, a method of providing selective occlusion with distal perfusion using a vascular occlusion device includes: (1) advancing the vascular occlusion device in a stowed condition along a blood vessel to a position adjacent to one or more peripheral blood vessels in the portion of the vasculature of the patient selected for occlusion while the vascular occlusion device is tethered to a handle outside of the patient; (2) transitioning the vascular occlusion device from the stowed condition to a deployed condition using the handle wherein the vascular occlusion device at least partially occludes blood flow into the one or more peripheral blood vessels selected for occlusion wherein the position of the vascular occlusion device engages with a superior aspect of the vasculature to direct blood flow into and along a lumen defined by a covered scaffold structure of the vascular occlusion device; (3) deflecting a portion of an unattached zone of the covered scaffold in response to the blood flow through the lumen of the covered scaffold into an adjacent opening of the one or more peripheral blood vessels in the portion of the vasculature of the patient selected for occlusion; (4) transitioning the vascular occlusion device from the deployed condition to the stowed condition using the handle; and (5) withdrawing the vascular occlusion device in the stowed condition from the patient.
This and other embodiments can include one or more of the following features. The one or more peripheral blood vessels in the portion of the vasculature of the patient selected for occlusion can be selected from the group consisting of a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery. The covered scaffold unattached zone can further include a position of a portion of the unattached zone to deflect into a portion of at least one of a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery when the vascular occlusion device is positioned within a portion of the aorta.
In general, in one embodiment, a method of temporarily occluding a blood vessel includes: (1) advancing a vascular occlusion device in a stowed condition along a blood vessel to a position adjacent to one or more peripheral blood vessels selected for temporary occlusion; (2) transitioning the vascular occlusion device from the stowed condition to a deployed condition wherein the vascular occlusion at least partially occludes blood flow into the one or more peripheral blood vessels selected for temporary occlusion while directing the blood flow through and along a lumen of a covered scaffold of the vascular occlusion device; and (3) transitioning the vascular occlusion device out of the deployed condition to restore blood flow into the one or more peripheral blood vessels selected for temporary occlusion when a period of temporary occlusion is elapsed.
This and other embodiments can include one or more of the following features. Directing the blood flow through and along the lumen of the vascular occlusion device can maintain blood flow to components and vessels distal to the vascular occlusion device while at least partially occluding the blood flow to the one or more peripheral blood vessels. The one or more peripheral blood vessels can be the vasculature of a liver, a kidney, a stomach, a spleen, an intestine, a stomach, an esophagus, or a gonad. The blood vessel can be an aorta and the peripheral blood vessels are one or more or a combination of: a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery.
In general, in one embodiment, a method of reversibly and temporarily occluding a blood vessel includes: (1) advancing an at least partially covered scaffold structure of a tethered vascular occlusion device to a portion of an aorta to be occluded; and (2) using a handle of the vascular occlusion device to deploy the at least partially covered scaffold structure within the aorta to occlude partially or completely one or more or a combination of: a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery using a portion of a multiple layer scaffold covering while simultaneously allowing perfusion flow through a lumen of the at least partially covered scaffold structure to distal vessels and structures.
This and other embodiments can include one or more of the following features. The insertion of the vascular occlusion device or of the at least partially covered scaffold device to a blood vessel which is the aorta can be introduced by transfemoral artery approach or by trans-brachial artery approach or by trans-radial artery approach. The method can further include advancing the vascular occlusion device over a guidewire into a position adjacent to a landmark of the skeletal anatomy. A portion of an unattached zone of a multiple layer scaffold covering can distend in response to blood flow along a lumen of the scaffold of the vascular occlusion device to occlude an opening of any of a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery.
In general, in one embodiment, a vascular occlusion device includes a handle having a slider knob, an inner shaft coupled to the handle, an outer shaft over the inner shaft and coupled within the handle to the slider knob, a scaffold structure having at least two legs and a multiple layer scaffold covering, and the multiple layer scaffold covering positioned over at least a portion of the scaffold structure. The at least two legs of the scaffold structure are attached to an inner shaft coupler in a distal portion of the inner shaft. The scaffold structure moves from a stowed condition when the outer shaft is extended over the scaffold structure and a deployed condition when the outer shaft is retracted from covering the scaffold structure.
This and other embodiments can include one or more of the following features. The scaffold structure can be formed from slots cut into a tube. The covering can be applied to nearly all, 80%, 70%, 60%, 50%, 30% or 20% of the scaffold structure. The multiple layer scaffold covering can be made of ePFTE, PTFE, polyurethane, FEP or silicone. The multiple layer scaffold covering can be folded over a proximal portion and a distal portion of the scaffold. After the multiple layer scaffold covering is attached to the scaffold, the scaffold can further include a distal attachment zone, a proximal attachment zone and an unattached zone. The multiple layer scaffold covering can further include a proximal attachment zone, a distal attachment zone and an unattached zone wherein a thickness of the multiple layer covering in the proximal attachment zone and the distal attachment zone is greater than the thickness of the multiple layer scaffold covering in the unattached zone. The multiple layer scaffold covering on the scaffold structure can have a thickness of 5-100 microns. Scaffold structure can have a cylindrical portion and a conical portion. The terminal ends of the conical portion can be coupled to the inner shaft. The inner shaft can further include one or more spiral cut sections to increase flexibility of the inner shaft. The one or more spiral cut sections can be positioned proximally or distally or both proximal and distal to an inner shaft coupler where the scaffold structure is attached to the inner shaft. The scaffold structure can further include two or more legs. Each of the two or more legs can terminate with a connection tab that is joined to a corresponding key feature on an inner shaft coupler. The multiple layer scaffold covering can include one or more or a pattern of apertures that are shaped, sized or positioned relative to the scaffold structure to modify the amount of distal perfusion provided by the vascular occlusion device in use within the vasculature. The multiple layer scaffold covering can include one or more regular or irregular geometric shapes arranged in a continuous or discontinuous pattern which is selected to adapt the distal perfusion flow profile of the vascular occlusion device in use within the vasculature. When in a stowed configuration within the outer shaft the overall diameter can be between 0.100 inches and 0.104 inches and when in a deployed configuration the covered scaffold has an outer diameter from 19 to 35 mm. The covered scaffold can have an occlusive length of 40 mm to 100 mm measured from a distal end of the scaffold to a scaffold transition zone.
A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are used, and the accompanying drawings of which:
Current treatments/managements for acute kidney injury (AKI), especially contrast-induced acute kidney injury are mainly supportive. They include for example, (1) evaluating and stratifying patients with Mehran risk score before performing percutaneous coronary intervention (PCI), (2) avoiding high-osmolar contrast media by using low-osmolar or iso-osmolar contrast media, (3) reducing the amount of contrast media during PCI, and (4) applying intravenously isotonic sodium chloride solution or sodium bicarbonate solution hours before and after PCI, (5) avoiding use of nephrotoxic drugs (such as nonsteroidal anti-inflammatory drugs, aminoglycosides antibiotics, etc.) See Stevens 1999, Schweiger 2007, Solomon 2010. However, none of them were proven with consistent effect in preventing CI-AKI.
Provided herein are devices and systems that specifically focus on solving the two main pathophysiological culprits of CI-AKI, which are renal outer medulla ischemia and/or prolonged transit of contrast media inside the kidneys.
In some embodiments, there are provided a device for treating acute kidney injury (e.g., CI-AKI) comprising a balloon catheter having at least one balloon, at least one sensor associated with the balloon and a position indication means wherein the balloon occludes the orifice of both sides of renal arteries after inflation while allowing blood flow going through the inflated balloon during application of the device inside abdominal aorta. In some embodiments, the position indication means is a radio-opaque marker, or the like.
Radio opaque markers are vital prerequisites on an increasing number of endovascular medical devices and are appropriately provided on the various embodiments to allow positioning of the temporary occlusion device. The value of radio opaque markers is clearly seen in visibility improvement during deployment of the device. Markers allow for improved tracking and positioning of an implantable device during a procedure using fluoroscopy or radiography.
While some embodiments have been described for use in mitigating CI-AKI, alternative non-balloon based occlusion or partial occlusion devices are also provided. Moreover, such alternative partial or complete peripheral occlusion devices simultaneously provide for distal perfusion blood flow into vessels and structures beyond the occlusion device.
As a result, various occlusion device embodiments may be provided that are adapted and configured to provide temporary occlusion of the peripheral vasculature of the suprarenal and infrarenal abdominal aortic area while maintaining distal perfusion.
Exemplary clinical applications include but are not limited to:
Total or nearly total vascular occlusion of blood flow during the surgical treatment of renal tumors through Retroperitoneoscopic Radical Nephrectomy (RRN), Open Radical Nephrectomy (ORN), Open Nephron-sparing Surgery (ONR), or other surgical interventions where it is beneficial to provide temporary vascular occlusion to peripheral organs.
Temporary vascular occlusion of target organs to prevent the influx of solutions (Contrast Medium, Chemotherapy agents) into sensitive organs.
In some embodiments, there is provided a device for treating acute kidney injury, comprising: a balloon catheter having at least one balloon, at least one sensor associated with the balloon and a position indication means wherein the balloon occlude the orifice of both sides of renal arteries after inflation while allowing blood flow goes through the inflated balloon during application of the device inside abdominal aorta.
The various balloon based device descriptions and associated methods may be modified to accomplish any of the above mentioned or other similar vascular occlusion procedures using an embodiment of a partial covered scaffold occlusion device. Additionally, in some embodiments, there is provided for radial expansion of a nitinol scaffold to allow apposition of the attached membrane to the wall of the aorta, to temporarily occlude the flow of blood to the peripheral vasculature. Importantly, embodiments of the radial occlusion device are designed to allow continued distal perfusion while occluding the entrance into the target arteries. In one embodiment, the catheter based radial occlusion system with simultaneous distal perfusion is advanced over a guidewire. In one aspect, a 0.035″ guidewire is used. In some embodiments, proper position of the occlusion device is obtained using one or more radio opaque marker bands or other suitable structures visible to medical imaging systems.
Referring to
Referring to
In certain embodiments, the device comprises a balloon catheter having a first balloon, a second balloon and at least one sensor associated with the second balloon. In some embodiments, the device comprises a balloon catheter having a first balloon, a second balloon and at least one sensor associated with the second balloon.
In some embodiments, the first balloon is donut-like after inflation. In certain embodiment the first balloon is butterfly-like after inflation.
Referring to
The inflation of the second balloon 503 is to the extent not totally occludes the aorta blood flow. As shown in
The analysis of data from the pressure sensors can be used as instantaneous titration of distention degree of the second balloon to provide adequate pressure gradient, and hence adequate vortex flow into renal arteries. In addition, the altered aorta blood flow will increase the renal artery blood flow, due to the location proximity and the diameter of the distended the second balloon. In some embodiments, the diameter of the distended second balloon is adjustable such that the diameter of the distended balloon is not too large to totally obstruct aorta blood flow and the altered aorta blood flow will not cause inadequacy of aorta blood flow at distal aorta or branches of aorta, i.e. right and left common iliac artery. Furthermore, the aorta wall will not be injured by the balloon distension.
Also shown in
In some embodiments, there are two sets of pressure sensors, one at the supra-renal aorta side of the balloon, the other at the infra-renal aorta side of the balloon. The two sensors can continuously measure the pressure and the measured data can be exhibited at the control box outside of the patient's body. The pressure difference between the two sensors will be exhibited on the control box. Physicians can read the pressure difference and adjust the size of balloon by way of a control box. Or the control box can do the adjustment of size of balloon automatically.
In some embodiments, the device for treating acute kidney injury further comprises a side aperture on the balloon catheter for application of normal saline or other medication infused from the control box, through the catheter into the supra-renal aorta. In some embodiments, normal saline (or other medication) is applied via a side aperture between the first and second balloon. In some embodiments, normal saline (or other medication) is applied via the tip of catheter.
As illustrated in
Referring to
As illustrated in
In some embodiments, the balloon catheter further includes a guidewire and a spinning propeller. In certain embodiments, the spinning propeller spins around the central guidewire to generate directional augmented renal artery blood flow toward the kidney. In certain embodiments, the spinning propeller is wing shape or fin shape. In certain embodiments, the device further comprises another catheter comprising a guidewire and a spinning propeller to generate directional augmented blood flow to the other kidney. In certain embodiments, the additional catheter having a spinning propeller is functioned independently and simultaneously with the balloon catheter to generate directional augmented blood flow to each side of kidney.
In some embodiments, the infra-renal side of the vascular occlusion device or the disturbing means (such as infra-renal tunnel membrane) can inject saline via injection hole or using the inner shaft into the aorta to dilute the contrast media before it flows into the renal arteries. One or more injection holes may be located along the inner shaft proximal to the atraumatic tip or proximal or distal to the inner shaft coupler 1530.
As illustrated in
To support such cone shaped structure, the wire device comprises wires 1710 with at least 3 wires. In some embodiments, there are 4 to 24 wires, 5 to 22 wires, 6 to 20 wires, 8 to 18 wires, or 10 to 16 wires. In some embodiments, there are 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 wires in the wire device partially covered with tunnel membrane. If needed, a skilled person in the art can prepare a wire device in accordance with the practice of the present invention to any number of wires suitable to provide a disturbing means. The wire may be any superelastic material such as nitinol.
Pseudoelasticity, sometimes called superelasticity, is an elastic (reversible) response to an applied stress, caused by a phase transformation between the austenitic and martensitic phases of a crystal. It is exhibited in shape-memory alloys. Pseudoelasticity is from the reversible motion of domain boundaries during the phase transformation, rather than just bond stretching or the introduction of defects in the crystal lattice (thus it is not true superelasticity but rather pseudoelasticity). Even if the domain boundaries do become pinned, they may be reversed through heating. Thus, a superelastic material may return to its previous shape (hence, shape memory) after the removal of even relatively high applied strains.
The shape memory effect was first observed in AuCd in 1951 and since then it has been observed in numerous other alloy systems. However, only the NiTi alloys and some copper-based alloys have so far been used commercially.
For example, Copper-Zinc-Aluminum (CuZnAl) was the first copper based superelastic material to be commercially exploited and the alloys typically contain 15-30 wt % Zn and 3-7 wt % Al. The Copper-Aluminum, a binary alloy, has a very high transformation temperature and a third element nickel is usually added to produce Copper-Aluminum-Nickel (CuAlNi). Nickel-Titanium Alloys are commercially available as superelastic material such as nitinol. In some embodiments, the superelastic material comprises copper, aluminum, nickel or titanium. In certain embodiments, the superelastic material comprises nickel or titanium, or combination thereof. In certain embodiments, the superelastic material is nitinol.
Specific structures can be formed by routing wires (bending one or a few wires and weaving into final shape) or cutting superelastic tube (laser cutting out the unwanted parts and leaving final wires in place) or cutting superelastic sheet (laser cutting out the unwanted parts and annealing the sheet into a cone shape.
Similarly, in some embodiments, the disturbing means (e.g., the wire device 1702) can inject saline from one or more injection hole 1708 via an infusion tube 1707 at the distal opening 1704 or the proximal opening 1705, or combination thereof into the aorta to dilute the contrast media further before it flows into the renal arteries. See
In some embodiments, the cone shaped wire device comprises an upper cylinder portion 1811 as illustrated in
As illustrated in
In yet another embodiment, first and second balloons 102, 103 may be replaced by an expanded foam or other biocompatible sealant structure that may be compressed against the vessel wall. The deployed sealant structure under radial force generated by the wire structure or other scaffold embodiment seals against the vessel wall sufficient to fully or at least substantially seal to the vessel wall such that all or substantially all of the blood flow within the vessel flows through the tunnel membrane. Additionally or optionally, the tunnel membrane may be solid or include apertures to allow for various amounts of localized perfusion (see for example
The position indication means 105 may for example be a radio-opaque marker. One or more position indication means 105 may be located on the tip of the catheter 101, on the proximal balloon 103, on the distal balloon 102, or any combination thereof. The position indication means 105 may be used to monitor the position of the device 100 upon insertion, during use, and during removal. The device 100 may be inserted into the abdominal aorta for example by using either a trans-femoral arterial approach, a trans-brachial artery approach, or a trans-radial artery approach.
In some embodiments, the aperture 106 and the surrounding wire 107 comprise at least one set of the aperture 106 and the surrounding wire 107 on the tunnel membrane. In some embodiments, there are one to four sets, two to six sets, three to nine sets, four to twelve sets, five to fifteen sets, or six to eighteen sets. In some embodiments, there may be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, or 18 sets of the aperture and the surrounding wire on the tunnel membrane. If needed, a person skilled in the art can prepare a wire device in accordance with the practice of the present disclosure to any number sets of the aperture and the surrounding wire suitable to provide a flow passage means. The wire may be any superelastic material, for example nitinol. The wire may be made of any superelastic or pseudoelastic material, for example nitinol, alloys of nickel-titanium, or any combination thereof. In some embodiments, the superelastic material may comprise one or more of nickel, titanium, or any combination thereof. Alternatively, any of the above may be modified for use as a wire frame scaffold used with a covering, membrane, coating or tunnel membrane described herein without provision for an aperture 106. Additionally or optionally, the braid embodiments described herein may be include interleaved longitudinal wires to provide an adjustable stiffness. Additionally, the longitudinal wires are provided so as to remain aligned to the central axis of the catheter. Still further, aspects of the fabrication technique and weave patterns used in the braid structure are utilized to modify or adjust a foreshortening characteristic of the braid structure when used as an partially covered scaffold vascular occlusion device.
The expandable mesh braid or the scaffold may for example be made of a superelastic material such as nitinol. The braid or scaffold may be made of any superelastic or pseudoelastic material, for example nitinol, alloys of nickel-titanium, or any combination thereof. In some embodiments, the superelastic material may comprise one or more of copper, aluminum, nickel, titanium, or any combination thereof. The expandable mesh braid may for example be made of steel or any other mesh-grade material. The expandable mesh braid may be provided with a tunnel or occlusion membrane 1600 embodiment as described herein. Optionally, the braid or scaffold or portion thereof may be coated such as with a hydrophobic coating, a hydrophilic coating, or a tacky coating for enhanced occlusion properties. Additionally or optionally, one or both of the inner and outer braid surfaces may be coated with ePTFE, PTFE, polyurethane or silicone. In some embodiments, the thickness of the coating is from 5 to 100 microns. Still further, the shape of the braid or scaffold may be adjusted to better fit into the geometry of the abdominal aorta, for example the diameter of the lower part of the braid may be smaller than the diameter of the upper part of the braid. It is to be appreciated that these coating concepts may also be applied to the various scaffold embodiments described herein.
Actuation of the catheter shaft for deployment of the expandable mesh braid may, for example, comprise translating the inner and outer shafts such that the distal end of the outer shaft moves closer to the distal end of the inner shaft.
The vascular occlusion device 1500 may further comprise a time-delayed release mechanism configured to automatically collapse the expandable occlusion structure (ie., mesh braid or scaffold) after a pre-determined amount of time following deployment. The time-delayed release mechanism may, for example, comprise an energy accumulation and storage component and a time-delay component. For example, the time-delayed release mechanism may comprise a spring with a frictional damper, an example of which may be included in the handle 1550. The energy accumulation and storage component may for example be a spring or spring-coil or the like. The time-delayed release mechanism may for example be adjustable by one or more of the user, the manufacturer, or both. The time-delayed release mechanism may further comprise a synchronization component to synchronize the injection of a contrast media or other harmful agent with the transition of the vascular occlusion device between a stowed configuration and a deployed configuration to aid in preventing harm to structures vascularized by the peripheral vessels that are subject to selective occlusion by operation of the device. For example, injection of contract may be synchronized with occlusion of the renal arteries by the expandable mesh braid or covered scaffold such that a contrast media may be prevented or substantially prevented or greatly reduced amounts from entering the renal arteries.
Various embodiments of a vascular occlusion device 1500 are described and illustrated herein and with specific reference to
The scaffold 1510 includes a central longitudinal axis 1511 along the inner shaft 1525. The scaffold 1510 includes a proximal end 1513, a distal end 1515, and a plurality of cells 1517. There is also a scaffold transition zone 1518 adjacent to the two or more legs 1519. Each leg 1519 terminates on proximal end in a connection tab 1521. Inner shaft coupler 1530 with key features 1531 to mate with connection tabs 1521 on the proximal end of legs 1519.
The inner shaft 1525 has a proximal end 1526 and a distal end 1528. The proximal end 1526 is in communication with the hemostasis valve 1599 in the proximal end of handle 1550. (See
In one embodiment, the scaffold structure 1510 terminates in one end with leg connection tabs 1521 as shown in
The inner shaft coupler 1530 is sized for placement on hypotube or central inner shaft 1525. The inner shaft coupler 1530 has keyed or complementary features 1531 to engage with the leg connection tabs 1521 of the scaffold. The proximal end features 1521 of the scaffold legs 1519 are keyed to mate with the inner shaft coupler 1530. The complementary cut outs 1531 used to join the leg tabs 1521 may come in a wide array of shapes and sizes to ensure orientation and position of the scaffold 1510 relative to the central or inner shaft 1525. In some embodiments staggering, offset patterns or other reduction techniques along with keying locations may also help reduce device size.
In the view of
An exemplary vascular occlusion device 1500 includes a handle 1550, an outer shaft 1580, an inner shaft or hypotube 1525 and a covered scaffold coupled to the distal end of the inner shaft 1525. A slider 1556 on the handle 1550 is coupled to the outer shaft 1580. As the slider 1556 moves along a slot 1553 in the handle, the outer shaft moves relative to the scaffold 1510 allowing the scaffold to move into a deployed configuration or remain within a stowed configuration.
The scaffold 1510 includes a central longitudinal axis 1511 along the inner shaft 1525. The scaffold 1510 includes a proximal end 1513, a distal end 1515, and a plurality of cells 1517. There is also a scaffold transition zone 1518 where the scaffold structure transitions to the leg 1519. The leg 1519 terminates on proximal end in a connection tab within a key feature within the inner shaft coupler 1530.
The inner shaft 1525 has a proximal end 1526 and a distal end 1528. The proximal end 1526 is in communication with the hemostasis valve 1599 in the proximal end of handle 1550. (See
The liner, cover, membrane or scaffold covering 1600 is also visible in this view. As described in greater detail below with regard to
It is to be appreciated that a number of different scaffold coverings 1600 may be provided that will provide for at least partial occlusion of the peripheral vessels while simultaneously providing for perfusion blood flow to the vessels and structures distal to the vascular occlusion device. Additional details of the scaffold covering 1600 are described below with regard to
In some alternative embodiments, all of the scaffold structure but the legs are covered by a suitable scaffold covering 1600. The distal end to a portion of the scaffold where the legs are extending towards the coupling device as detailed above. In this way, some scaffold embodiments deploy into much like a tube or barrel shape which extends along the adjacent vessel wall where the scaffold is deployed. Any peripheral vessel along the covered portion of the main vessel will be partially or fully occluded. The covering extends from the distal end of the scaffold structure to the proximal end where the scaffold structure transitions to the legs and then tabs for joining to the coupling on the inner tube. The scaffold covering 1600 is shown as transparent in the view of
Similar to other embodiments, there is a handle on the proximal end of the vascular occlusion device. A sheath or outer shaft is disposed over the inner shaft or hypotube and coupled to the handle. A slider knob in the handle controls the position of the sheath relative to the hypotube and scaffold device. In this view, the slider knob is shown in a proximal position on the handle. In this position the sheath is moved proximally towards the handle thereby allowing the scaffold to transition from the stowed configuration to the deployed configuration. In the deployed configuration the vascular occlusion device engages the vessel interior wall to seal partially or completely as desired by the amount of occlusion and distal perfusion to be achieved by a specific embodiment.
In this embodiment, the full scaffold device is covered completely or considered a 100% coverage of the scaffold with the scaffold covering 1600. Advantageously, the directed flow through or distal perfusion capability is adjustable by the number, size and arrangement of the openings 1654 as shown in
Distal end of the covering aligns to the distal most portion of the scaffold structure. When deployed within the vasculature the covered portion of the scaffold is one factor used to refine and define occlusion characteristics of the device while the generally open central portion or other uncovered scaffold portions refine and define the device perfusion characteristics. Adjusting the relative amount and type of covering and open scaffold portions enables a wide array of occlusion and perfusion device characteristics. Proximal end of the covering extends along the scaffold structure so that approximately all of the scaffold structure is covered. The distal end of the covering is positioned along the scaffold structure and the transition portion. The legs are covered. Distal perfusion is provided by flow through perfusion apertures formed in the membrane covering. Perfusion apertures may be provided as a pattern of small openings in the scaffold covering. Slider is used to control position of over shaft or sheath and is shown in position to retract the outer shaft.
Occlusion and perfusion device embodiment with a partial scaffold covering or membrane. In some embodiments, the scaffold covering 1600 or membrane may also cover only a portion of the scaffold in any of a variety of shapes such as the cut cylinder shape shown here. Other geometric shapes or irregular shapes may be employed for membrane overall shapes which will enable a wide array of different and controllable occlusion parameters along with a variety of simultaneous distal perfusion capabilities. When deployed within the vasculature the covered portion of the scaffold is one factor used to refine and define occlusion characteristics of the device while the generally open central portion or other uncovered scaffold portions refine and define the device perfusion characteristics. Adjusting the relative amount and type of covering and open scaffold portions enables a wide array of occlusion and perfusion device characteristics (see
The vascular occlusion device of
A portion of the distal and proximal attachment zones of one of the scaffold covering sections is visible in this view along with a section of the spiral cut inner shaft.
In various embodiments, the occlusion system describe herein is compatible with other cardiac catheterization lab or interventional radiology lab workflow, designed with user-friendly functions and inserted and removed from patient similar to insertion of off-the-shelf introducer sheath with add-on function of temporary peripheral vascular occlusion. The device is an “assist device” which does not interfere with the standard catheterization procedure and comply with the standard activities in the catheterization lab.
First, at step 4505, there is the step of advancing a vascular occlusion device in a stowed condition along a blood vessel to a position adjacent to one or more peripheral blood vessels selected for occlusion while the device is tethered to a handle outside of the patient.
Next, at step 4510, there is the step of transitioning the vascular occlusion device from the stowed condition to a deployed condition wherein the vascular occlusion at least partially occludes blood flow into the one or more peripheral blood vessels selected for occlusion.
Next, at step 4515, there is the step of transitioning the vascular occlusion device out of the deployed condition to restore blood flow into the one or more peripheral blood vessels selected for occlusion.
Finally, at step 4520, there is the step of withdrawing the vascular occlusion device from the patient using the handle tethered to the scaffold structure.
First, at step 4610, there is the step of advancing an at least partially covered scaffold structure to a portion of an aorta to be occluded while the scaffold structure is attached to a handle outside of the patient.
Next, at step 4620, there is the step of using the handle outside of the patient to deploy the at least partially covered scaffold structure within the aorta to occlude partially or completely one peripheral vessel or more than one or a combination of peripheral vessels of the aorta. This step may be appreciated with reference to
Next, at step 4630, there is the step of allowing blood perfusion flow through the at least partially covered scaffold structure to distal vessels and structures.
Next, at step 4640, there is a step of distending an unattached portion of the scaffold covering in response to blood flow through the scaffold structure.
Next, at step 4650, there is a step of transitioning the partially covered scaffold structure into a stowed condition using the handle outside of the patient. Thereafter, removing the stowed scaffold structure from the patient vasculature using the handle that is tethered to the scaffold structure.
First, at step 4710 there is a step of advancing a stowed vascular occlusion device into an abdominal aorta of a patient who has or will receive injections of radiological contrast.
Next, at step 4720, there is a step of transitioning the vascular occlusion device from the stowed condition to a deployed condition using a handle outside of the patient and attached to the occlusion device.
Next, at step 4730, there is a step of directing the blood flow in the supra-renal portion of the aorta containing radiological contrast into the lumen of the vascular occlusion device to prevent blood flow entering the renal arteries while allowing perfusion of the distal arterial vasculature.
Next, at step 4740, there is a step of distending a portion of a multiple layer membrane of the vascular occlusion device outwardly from the scaffold structure in response to arterial blood flow so that the distended portion of the multiple layer membrane at least partially occludes an ostia of a renal artery.
Next, at step 4750, there is a step performed when perfusion with occlusion protection of the renal arteries is concluded. At this point, the vascular occlusion device is transitioned back into the stowed condition and removed from the patient using the handle outside of the patient and attached to the vascular occlusion device.
In some embodiments, the scaffold covering 1600 comprises a multiple layer structure that is attached to all or to select portions of the scaffold frame 1510. In some embodiments, the multiple layer covering is used to encapsulate all or a portion of the scaffold structure including the legs. The multiple layer scaffold covering may be a partial scaffold covering as seen in the embodiments of
In still other embodiments, any of the above described disturbing means such as a tunnel membrane illustrated and described in
In view of the above, in other additional optional embodiments and configurations of the vascular occlusion devices described herein, an embodiment of a vascular occlusion device may be used to provide a method of providing occlusion of a portion of the vasculature of a patient with perfusion distal to the occlusion portion using the following method. First, there is a step of advancing a vascular occlusion device in a stowed condition along a blood vessel to a position adjacent to one or more peripheral blood vessels in the portion of the vasculature of the patient selected for occlusion while the vascular occlusion device is tethered to a handle outside of the patient. Next, there is a step of transitioning the vascular occlusion device from the stowed condition to a deployed condition using the handle wherein the vascular occlusion device at least partially occludes blood flow into the one or more peripheral blood vessels selected for occlusion. Next, the position of the vascular occlusion device which engages with the superior aspect of the vasculature to ensure that blood flow is directed into and along the lumen defined by the covered scaffold structure. As a result, the scaffold structure occludes the vessels targeted for temporary occlusion while directing the blood flow along the lumen of the vascular occlusion device through the interior of the covered scaffold to thereby maintain blood flow to blood vessels distal to the occluded portion of the vasculature. Furthermore, in some embodiments, the unattached zone of the covered scaffold deflects, bulges, or deforms in response to the blood flow now directed through the lumen of the covered scaffold. As a result, a portion of the unattached zone of the covered scaffold is urged into an adjacent opening of the peripheral blood vessel that is the target of the selected temporary occlusion procedure. It is to be appreciated that the location, size and number of unattached zones of a covered scaffold embodiment may vary according to the size, number and location of peripheral vessels selected for temporary occlusion. Thereafter, when the period of providing temporary occlusion is completed, the step of transitioning the vascular occlusion device from the deployed condition to the stowed condition using the slider on the handle which remains connected to the scaffold structure at all times during use. Once in the stowed configuration, the step of withdrawing the vascular occlusion device from the patient is performed by appropriate movement of the handle.
In another aspect, a method for mitigating exposure of the kidneys to medical contrast media is disclosed. The method comprises: inserting a catheter having a partially covered scaffold device into the vasculature and advancing into a desired position within an abdominal aorta; and deploying the scaffold so that the covering, membrane or tunnel structure is in a position to partially or complete occlude the renal arteries during use of contrast media while simultaneously providing perfusion blood flood distal to the occluding device. In certain embodiments, the insertion of the partially covered scaffold occlusion device to an aorta is accomplished by a transfemoral artery approach or by a trans-branchial artery approach or by a trans-radial artery approach. In some embodiments, the catheter and scaffold occlusion device are inserted along a guidewire and moved into a position to partially or completely occlude one or more blood vessels under appropriate medical imaging guidance such as fluoroscopy. Additional details and illustrations of the various vascular access routes described herein may be appreciated with reference to US Patent Application Publication US 2013/0281850 entitled, “Method For Diagnosis and Treatment of Artery,” which is incorporated herein by reference for all purposes. The above details and alternative method steps may also be applied to provide additional embodiments and variations to the steps detailed for methods 4500, 4600 and 4700 described herein.
Those of ordinary skill will appreciate that the devices and methods described herein meet the objective of a catheter based vascular occlusion system that will be able to be used to access the aorta with the ability to provide temporary occlusion of target vasculature while maintaining perfusion to the lower limbs vasculature. US Patent Application Publication US 2016/0375230 and US 2018/0250015 are incorporated herein by reference for all purposes.
The various embodiments of the vascular occlusion with perfusion devices described herein provide in a general way a flow disturbing means within the blood flow of the aorta. The distal most end of the scaffold engages substantially circumferentially with the interior wall of the aorta so that substantially all of the blood flow in the aorta flows into and along the central axis of the scaffold and out of the scaffold proximal openings. In one illustrative embodiment, a vascular occlusion device is positioned such that the scaffold or tunnel membrane shunts blood flowing from the supra-renal aorta through the scaffold or tunnel membrane, bypassing the renal arteries, and into the intra-renal aorta as the flow exits the scaffold. Alternative distal most segments of the scaffold may be used for greater contact area with the blood vessel where the vascular occlusion with perfusion device is employed. Optionally, the distal most segment of the scaffold may be in the shape of a flared distal end of the scaffold (see
Exemplary Vascular Occlusion Devices and Covered Scaffolds
In some specific embodiments, the scaffold 1510 is fabricated as a laser cut tube of overall length from the connection tab 1521 on the legs 1519 to the scaffold distal end 1515 ranges from 40 mm to about 100 mm. Typically, the vascular occlusion device is delivered and maintained within a stowed configuration compressed with an 8 Fr compatible outer shaft or sheath. As best seen in
Turning now to an exemplary bare scaffold structure as shown in
Additional details of an exemplary occlusion with perfusion devices and systems are available with reference to co-pending International Application No. PCT/US2020/052899 titled “Devices and Methods for at least Partially Occluding A Blood Vessel While Maintaining Distal Perfusion,” filed on Sep. 25, 2020, U.S. Pat. No. 10,300,252 to Lee et al., and U.S. Pat. No. 10,441,291 to Koo et al. Additional details of introducer devices are available with reference to U.S. Pat. No. 6,090,072 to Kratoska et al, U.S. Pat. No. 5,542,936 to Razi, US Patent Application Publication US 2015/0094795 to Ginn, et al., and US Patent Application Publication US 2013/0281850 to Okajima et al.
The various embodiments of introducer with occlusion with perfusion devices described herein are used using conventional surgical techniques for introducer sheath and dilator kits. Introducers may be modified to function as an outer shaft or expandable outer shaft as described herein. Similarly, unmodified dilators may be used with an occlusion with perfusion device as described herein. Advantageously, the overall dimensions of the combination devices described herein may be reduced by modifying a dilator to have a pocket sized to receive a stowed occlusion with perfusion device. Modified dilators having pockets for device stowage are further described with respect to
In still other embodiments, there may also be an elongate dilator with a proximal Luer assembly configured to be inserted into the working lumen of the introducer sheath through a proximal seal coupled to a hub structure, which is also coupled to an extension tube with stopcock, which may be utilized for infusion of fluids into the introducer lumen, for example. The inventive introducer will comprise an elongate tubular member coupled proximally to the hub and being made from a relatively non-expandable polymeric material or combination of polymeric materials, or other material based on whether or to what degree the introducer will be adapted and configured to have expansion capabilities.
As shown in
The introducer sheath 40 includes a sheath having open distal and proximal ends. More specifically, the introducer sheath 40 includes, for example, a sheath tube 41 having open distal and proximal ends, a sheath hub 42, a hemostasis valve 43, a side port 44, a tube 45, and a three-way cock 46. The sheath tube 41 is percutaneously put indwelling (indwelled) in a body lumen, after which an angiography catheter, serving as an example of a diagnostic instrument, or a balloon, a stent or the like, serving as an example of a therapeutic instrument, is inserted into and moved along the sheath tube 41, to be thereby introduced into the body lumen. The sheath hub 42 permits the sheath tube 41 and the side port 44 to communicate with each other interiorly of the sheath tube 41 and the side port 44. The hemostasis valve 43 is incorporated in the sheath hub 42. The hemostasis valve 43 stanches (stops) blood flowing out of a blood vessel through the sheath tube 41. The side port 44 permits communication between the sheath tube 41 and the tube 45. The tube 45 permits communication between the side port 44 and the three-way stopcock 46. The three-way stopcock 46 is used to inject a liquid such as physiological saline into the introducer sheath 40 through the tube 45 and the side port 44.
It is to be appreciated that in the various embodiments that follow, an introducer sheath 40 or similar component may be adapted for use as an outer shaft or outer sheath as detailed herein. Similarly, the various operable capabilities described above or with respect to
Examples of the material forming the outer shaft or sheath 40 include polyethylene, polyethylene terephthalate, polypropylene, polyamides, polyamide elastomers, polyimides, polyurethane, PEEK (polyether ether ketone), and fluorine-based polymer such as ETFE, PFA, or FEP, among which ETFE and PEEK are preferred in consideration of an anti-kinking effect which will be described later.
The dilator 50 includes, for example, a dilator tube 51 and a dilator hub 52. The dilator tube 51 of the dilator 50 is inserted into and moved along the sheath tube 41 so the distal end of the dilator is positioned distally beyond the distal and of the sheath. The dilator tube 51 (dilator) assists the insertion of the introducer sheath 40 which is to be percutaneously indwelled in a body lumen. The dilator hub 52 holds the dilator tube 51 in the state of being detachably attachable to the sheath hub 42. The outer diameter of the dilator tube 51 is substantially equal to or slightly smaller than the inner diameter of the sheath tube 41. The various dilator embodiments described in
The instrument 60 is inserted into the introducer sheath 40 after the introducer sheath 40 is inserted in a blood vessel and after the dilator 50 is drawn out of the introducer sheath 40 and the guide catheter 5105 introduced and advanced beyond the sheath 40 and the occlusion device 1500. The instrument 60 has an elongated body, and is inserted into the blood vessel through the introducer sheath 40. In the case of the instrument 60 being a diagnostic instrument, examples of the instrument 60 include an angiography catheter, an intravascular ultrasound testing instrument, or an intravascular optical coherence tomography instrument. In the case of the instrument 60 being a therapeutic instrument, examples of the instrument 60 include a balloon catheter, a drug-eluting balloon catheter, a bare metal stent, a drug-eluting stent, a drug-eluting biodegradable stent, a rotablator, a thrombus suction catheter, or a drug administration catheter. It is to be appreciated that the various embodiments and combinations of outer sheath, expandable outer sheath, occlusion device inner shaft, guide catheter and handle may be modified and adapted for use in combination with the variety of instruments 60 as well as those devices detailed in
A procedure for percutaneously inserting the introducer sheath and occlusion with perfusion device combination 40 of this embodiment into a blood vessel will be specifically described below, referring to
The sheath tube 41 of the introducer sheath 40 is inserted through skin 200, shown in
Various alternative introducer constructions are described with reference to
As shown in
The outer diameter D2o of the introducer sheath 40 shown in
In still other aspects, those of ordinary skill will appreciate that “a device” accessing the vasculature using an embodiment of the combination introducer and occlusion device includes a diagnostic instrument or a therapeutic instrument. Moreover, these various principals of sheath design alone or in combination with those of
A procedure for diagnosis or treatment of a coronary artery 320 by use of a diagnostic instrument or a therapeutic instrument through the introducer sheath and occlusion with perfusion device according to a suitable embodiment will now be described with reference to
In a case of vascular access point R, the diagnosis of the coronary artery 320 of the patient 300 is conducted by inserting a diagnostic instrument through a radial artery 340 or ulnar artery 350 into the coronary artery 320 of the patient 300. Still using access point R, treatment of the coronary artery 320 is conducted by inserting a therapeutic instrument through the radial artery 340 or ulnar artery 350 into the coronary artery 320, the procedure is carried out as follows.
First, an introducer having the dilator 50 inserted into and extending along the introducer sheath 40 is inserted into the radial artery 340, and then the dilator 50 is drawn out, with the introducer sheath 40 kept indwelling in the radial artery 340. It is also possible for the introducer to be inserted into the ulnar artery 350. Next, a diagnostic instrument having an outer diameter smaller than the maximum outer diameter permitted to be inserted into the introducer sheath 40 is inserted into the introducer sheath 40 and is inserted through the radial artery 340 into the coronary artery 320. A diagnosis is then made through the diagnostic instrument whether or not the coronary artery 320 is stenosed, and the diagnostic instrument is then drawn out. Further, when the coronary artery 320 is found stenosed, the introducer sheath 40 is kept indwelling in the radial artery 340, then, in this condition, a therapeutic instrument or a catheter permitting the therapeutic instrument to be inserted therein, which therapeutic instrument or catheter has the maximum outer diameter permitting insertion into the introducer sheath, is inserted into the introducer sheath 40, is inserted through the radial artery 340 into the coronary artery 320. When a catheter permitting insertion of the therapeutic instrument is inserted into the sheath, the therapeutic instrument is inserted into the catheter. Treatment is then performed. The diagnostic instrument having an outer diameter smaller than the maximum outer diameter permitting insertion into the introducer sheath 40 has an outer diameter smaller than the maximum outer diameter by, for example, 1 Fr size.
The above basic vascular access technique may be performed using an access procedure with the femoral artery (access route F) or using the vasculature of the lower limb such as the tibial artery or other suitable access route (access route LL). Alternative embodiments of the introducer with occlusion device may be sized appropriately according to the size of the access point vessels associated with access routes R, F and LL. The relative sizes of the outer sheath or introducer as well as the lumen of inner shaft of the occlusion with perfusion device are adjusted accordingly.
In various alternative embodiments, one or more of the vascular access steps may be modified by one or more of the steps described in method 800 in
In the case where the introducer sheath is introduced through access point LL in a part near the back of the knee, the instep, or the heel to be set indwelling in a posterior tibial artery 390, a fibular artery 400, an anterior tibial artery 380, or a popliteal artery 370. Generally vascular access point LL in
This embodiment of the diagnostic/treatment method permits realization of a variety of effects.
In the case where diagnosis of a second artery of the patient 300 is conducted by inserting a diagnostic instrument through a first artery into the second artery and then treatment of the second artery of the patient 300 is conducted by inserting a therapeutic instrument through the first artery into the second artery, various effects are produced according to the size of the introducer sheath 40. For instance, in the case where the diagnosis of the coronary artery 320 of the patient 300 is conducted by inserting the diagnostic instrument through the patient's radial artery 340 or ulnar artery 350 (Access Route R) into the coronary artery 320 and subsequently the treatment of the coronary artery 320 is conducted by inserting the therapeutic instrument through the patient's radial artery 340 or ulnar artery 350 into the coronary artery 320, various effects are produced according to the size of the introducer sheath 40. In view of this, sizes of two kinds of introducer sheaths 40 will be specifically described.
In the case of an introducer sheath 40 having an inner diameter of 1.9 to 2.5 mm and a wall thickness of 0.05 to 0.19 mm, corresponding to the “6 in 5” mentioned above, the following effects are produced.
In a case where a stenosis is found upon diagnosis of the coronary artery 320 of a heart 310 of the patient 300 and treatment is conducted in succession to (following) the diagnosis, instead of conducting the treatment some other time, for example, the introducer sheath 40 already set indwelling in the radial artery 340 or ulnar artery 350 does not have to be replaced by another one with a larger inner diameter. These or other procedures may be modified for use in a femoral artery to access the aorta using an embodiment of the introducer with occlusion and perfusion device. (see generally Access Route F in
In the case of conducting treatment in succession to diagnosis, in the previously used procedures, a sheath in which to insert and pass a device corresponding to an appropriate Fr size has had to be replaced by a sheath in which to insert and pass a therapeutic device corresponding to a larger Fr size. Such replacement of the sheath in the previously used procedures has produced various problems. The replacement of the sheath in the previously used procedures causes re-insertion of the sheath, leading to increased invasiveness to the patient 300 and a need for a sheath-replacing time. In addition, two sheaths are necessitated, which leads to increased cost.
In addition, the wall thickness, material composition and various other aspects of an introducer embodiment may be varied to accomplish the objective of delivery of large Fr size interventional devices in cooperation with modifications for low profile storage of an occlusion with perfusion device. It is to be appreciated that angiography catheters, intravascular ultrasound testing instruments and intravascular optical coherence tomography instruments can be applied or used as the intravascular instrument described herein. Still further, the introducer with occlusion device and method may be used to advantage with balloon catheters, drug-eluting balloon catheters, bare metal stents, drug-eluting stents, drug-eluting biodegradable stents, rotablators, thrombus suction catheters, or drug administration catheters or any other therapeutic intravascular instrument. Still further, guiding catheters and support catheters can be applied or used as the catheter. Thus, in using an embodiment of the introducer and occlusion with perfusion device, there are no specific restrictions as to the intravascular instrument or therapeutic instrument that may be utilized or deployed using the inventive introducer.
Referring to
With the introducer assembly in place, the associated dilator assembly may be removed (825). Interventional and/or diagnostic tools and/or prostheses may be inserted through the introducer and occlusion device combination. In some configurations the introducer is capable of expansion wherein the expandable portion or expandable section 6875 is localized, such that after a relatively large device or implement is passed through and past a given portion of the introducer, that portion re-collapses, at least partially or completely. The occlusion with perfusion device may be spaced apart from the outer wall of the introducer or moved into a deployed configuration during insertion of intravascular devices so as to allow for localized expansion of an introducer, if so configured.
In conjunction with insertion and advancement of interventional and/or diagnostic tools and/or prostheses inserted through the introducer temporarily transition the occlusion with perfusion device into a deployed or spaced apart position with respect to the introducer outer wall of the introducer to allow for localized expansion introducer in the location of the occlusion with perfusion device (830).
Additionally or optionally, if introducer has reversible, temporary or controllable expansion capability to allow for passage large Fr size devices during procedure.
Before injection of imaging contrast agent during an intravascular procedure, using the actuation device on the handle to transition the occlusion with perfusion device into a deployed condition to at least partially occlude the one or more renal ostia (840).
Inject imaging contrast agent into the vasculature (845).
Occlusion with perfusion time period during which occlusion with perfusion device limits blood flow into renal arteries (occlusion) while allowing blood flow to extremities proximal to the deployed occlusion member (perfusion) (850).
After time period of providing occlusion protection to the kidneys has elapsed, transition the occlusion with perfusion device back to a stowed condition against the outer wall of the introducer (855).
Repeat steps 840, 845, 850, 855 as desired for each subsequent injection of imaging contrast during the procedure (860).
After utilization of the interventional and/or diagnostic tools has been completed, they may be withdrawn proximally (865). Thereafter, the introducer with occlusion with perfusion device is removed from the vasculature (870). Finally, the surgical access closed (875).
The pocket 5745 may have a length corresponding to the length of an occlusion device from a position proximal to the coupling 1530 to the distal most portion of the occlusion device. In one embodiment, the length is 10 cm. The guide wire lumen 5732 of the dilator may be sized for a 0.018 inch guidewire. The lumen may have a diameter in the range from 0.035-0.0040 inches. In one embodiment, the recessed portion of the pocket sized to accommodate a 6 Fr guide catheter. The pocket dimensions may range from 0.095 to 0.1 inches.
In other alternative aspects of the inventive combination of an introducer and an occlusion device, there are provided a variety of alternative outer sheath or introducer configurations that will distend, expand or flex in order to translate an occlusion device into a stowed condition when using larger Fr sized guide catheters. Accordingly, when the guide catheter is present the flexible portion of the distal outer sheath may accommodate the occlusion device transition into a stowed configuration. A number of alternative configurations of expandable or distensible distal ends 6875 are described with regard to
In order to further the combination aspect of embodiments of the invention, it is desirable to have an introducer sheath or outer shaft 1580 that is suitable for reconstraining (i) a deployed occlusion device, (ii) a large or awkwardly shaped surgical instrument and/or (iii) implantable devices after delivery such that they may be repositioned or removed from the body, including medical devices that are being removed from a body with a larger diameter than that of the introducer or outer sheath. Such additional capabilities advance the single vascular access point advantages of the combined occlusion with perfusion device with an introducer sheath or outer shaft having these additional capabilities. In an alternative aspect, the same introducer sheath or outer shaft may be used to reposition a device within the body to an alternative delivery site. An introducer sheath or outer shaft or sheath constructed according to this description may be used to recover a deployed occlusion device, a portion of a deployed occlusion device in the case of an occlusion device for multiple branch occlusion, deliver a medical device, surgical instrument, or biological sample. A modified outer sheath or introducer embodiment will have a reduced risk of splitting or tearing when a device is positioned within the introducer or outer sheath. As used here, the terms sheath, introducer sheath and outer shaft are used interchangeably within the context of use with an inner shaft with an occlusion device and a guide catheter or therapeutic catheter accessing the vasculature via the single access point via the inner shaft and extending through the occlusion device.
According to one embodiment, a distal tip of an introducer sheath or outer shaft is constructed to expand radially and thus facilitate the retrieval and repositioning of surgical tools, implantable devices, or biological matter that have a larger diameter than the unexpanded diameter of the introducer sheath or outer shaft. The distal end of the introducer sheath or outer shaft may be formed with either a single layer or multiple layers of material which may be the same or different from the materials comprising the rest of the introducer sheath or outer shaft. In one embodiment, the distal end of the introducer sheath or outer shaft may have one or more straight or curved generally longitudinally-oriented slits. The slits extend through the thickness of one or more layers of the introducer sheath or outer shaft. During delivery of a device, the slits may be closed or open depending on desired delivery characteristics. If the device requires removal or repositioning, the slits in the introducer sheath or outer shaft separate and the introducer sheath or outer shaft diameter expands if necessary as the device is retrieved into the introducer sheath or outer shaft. An elastomeric layer holds the sliced portions of the introducer sheath or outer shaft together and provides an expandable layer so that the introducer sheath or outer shaft remains a single piece. The slits may extend longitudinally from the distal end to a location up to 15 cm along the length of the introducer sheath or outer shaft or more. Alternatively, the slits may begin at a location slightly away from the distal end and continue longitudinally for up to 15 cm along the introducer sheath or outer shaft or more.
In another embodiment, one or more zig-zag slits may be provided longitudinally along a length of the distal end of the introducer sheath or outer shaft and in a direction perpendicular to the radial axis of the introducer sheath or outer shaft, or it can have some angle relative to a perpendicular orientation, or they can have an overall curved shape. The zig-zag configuration of the slits may include straight cuts or separations in the introducer sheath or outer shaft. The zig-zag cuts also may be rounded at the peak and/or the valley of the cut, and/or along the length of the cut. In a preferred form, the size of the zig-zag slits are constructed so that in an expanded configuration (e.g., when a device has been retrieved) the teeth of opposing sides of the zig-zag do not completely separate. Thus, the introducer sheath or outer shaft minimizes the likelihood of a longitudinal tear of the elastomeric material, if present. It is desirable that the entire device that has been inserted into the introducer sheath or outer shaft remain in the introducer sheath or outer shaft and not extend through any perforations or tears in the introducer sheath or outer shaft.
The formations described above may be used together and other formations may be used to allow for radial expansion of the introducer sheath or outer shaft as the device is being positioned within the introducer sheath or outer shaft. These formations may or may not require longitudinal contraction. These formations can be present along a portion or the entire length of the sheath tip. Other materials can be added to the sheath tip, such as wires for strength, coatings to change friction characteristics, and coatings of a different durometer, or, the device can be made to have a minimal number of parts and portions.
The introducer sheath or outer shaft can be an introducer through which surgical instruments and implantable devices such as stents, filters, occluders, valves, or other devices are inserted into a living body. The introducer sheath or outer shaft can also be a retriever through which tissue or other biological matter, surgical instruments, and implantable devices are withdrawn from a living body. The cut of the introducer sheath or outer shaft material that forms the slits may be aligned with the radial axis or may be slanted or curved. The cut may be formed from a sharp object, such as a knife, or alternative methods may be used to form the slits.
In another embodiment, the introducer sheath or outer shaft or sheath may have a distal end that is partially or wholly comprised of braided material. In such a device that uses a braided configuration, the longitudinal length shortens as the radius expands. This embodiment has the advantage that individual segments of the introducer or outer sheath are not separated as the introducer or outer sheath expands radially.
A radially expandable distal end 6875 of an introducer sheath or outer shaft allows surgical instruments, biological matter, and implantable devices, including such devices as may be folded, compressed, or loaded in the sheath in a specialized manner such that the device can be introduced through a smaller diameter delivery sheath than otherwise possible, to be more easily deployed upon delivery to the desired site within the body. In a specific implementation, such a modified outer sheath may be advantageously employed to recover, collapse an occlusion with perfusion device onto an outer wall of a guide introducer or outer sheath within the occlusion with perfusion device. As a result, a radially expandable distal end 6875 of an introducer sheath or outer shaft 1580 may also allow and/or facilitate retrieval of surgical instruments and implantable devices, including devices that unfold or expand or otherwise deploy in some way after delivery within the body through a guide catheter, and within the introducer sheath or outer shaft, and occlusion with perfusion device is withdrawn. The expandable distal end 6875 can accommodate more easily the volume of a partially or wholly deployed device, and can overcome snags resulting from the geometry of a partially or wholly deployed device, reducing trauma to the vessel through which such instruments or implantable devices must be withdrawn. Once a device, such as a deployed occlusion with perfusion device is retrieved into the sheath or outer shaft, the sheath tip can further aid in the complete recovery of a device by acting to compress the device. It is desirable that an expandable distal end 6875 of an introducer sheath or outer shaft 1580 accommodate an article with a larger dimension than that of the outer shaft/outer sheath.
An outer sheath 1580 can expand radially at its distal end to accommodate an element (e.g., medical device) that is larger than the diameter of the outer sheath. At times it is desirable, sometimes necessary, to remove or reposition a medical device that has been previously deployed. An introducer shaft or outer shaft as described here allows a device to be removed or repositioned by expanding to accommodate the device as the device is brought within the introducer sheath or outer shaft. According to some embodiments, the introducer sheath or outer shaft is configured to reduce the possibility of tearing the elastomeric layer longitudinally along the introducer or outer sheath by the edges of a surgical instrument or implantable device being removed or repositioned.
Referring to the drawings, wherein like reference numerals designate identical or corresponding parts throughout the several views, and more particularly to
The introducer sheath or outer shaft 6010 can be various lengths, such as between 10 cm and 100 cm. The introducer or outer sheath can be longer or shorter as necessary for a particular application. The diameter of the introducer or outer sheath is typically between 5 and 20 French. Additionally, some devices are accessed using 24 Fr. Improvements continue and the sizes of devices that will access the vasculature using the inventive introduced and occlusion device combination will be expanding. Of course, the introducer sheath or outer shaft could have a larger or smaller diameter as a particular application warranted. Typical wall thickness of the introducer or outer sheath 6010 can vary greatly depending on the material selected and the length of the introducer sheath or outer shaft.
As illustrated in
The elastomeric layer may be disposed on the inside surface of the introducer sheath or outer shaft or on the outside surface of the introducer sheath or outer shaft or both. The layers of the introducer or outer sheath are bonded together, such as through heat bonding, adhesives, or other suitable methods to join the two or more layers. If the elastomeric layer is disposed on the outer surface of the introducer or outer sheath a heat shrink tube may be used. Although the thickness of the layer may vary depending on the needs of a particular application and the material selected, the thickness may be between about 0.001 and 0.025 inches (25 to 625 microns), preferably between about 0.006 and 0.008 inches (150 to 200 microns). Materials for the elastomeric outer cover may include silicone, polyurethane, or polyether-amide block copolymer, such as a material known as Pebax. The elastomeric layer(s) allows the introducer or outer sheath portions 6026 and 6028 to expand as much as needed to recapture or reposition the device. The elastomeric outer cover can be flush with an inner wall at the distal end of the introducer sheath or outer shaft, or the outer cover can extend beyond the inner wall a short distance to create an overhang that provides a less stiff and “softer” end. This softer tip can help to guide a divide that may have coils or other structures that could get caught if brought back into contact with a stiffer conduit. This overhang would typically have a length of about 0.005 to 0.5 inches (0.125 to 12.5 mm) and preferably about 0.1 inches (2.5 mm), and a thickness of about 0.005 to 0.1 inches (0.125 to 2.5 mm), and preferably about 0.02 to 0.04 inches (0.5 to 1.0 mm). In addition to the end portion, other sections of the introducer or outer sheath can include multiple layers.
The zig-zag pattern forms tooth shapes 6152 along the length of the zig-zag pattern. The shapes may be triangular as shown or, alternatively, rectangular, semi-circular or irregular. As depicted in
Referring to
In another embodiment, the expandable introducer sheath or outer shaft end portion 64130 includes a wall 64132 formed by braided material 64134 as illustrated in
Features of the embodiments described here include the following: (a) an outer sheath expansion zone or an expandable sheath tip facilitates the deployment and retrieval of the various embodiments of occlusion with perfusion devices described herein, surgical instruments, implantable devices, and biological matter; alone or in combination with (b) use of the expandable sheath tip to partially deploy, expand or inflate an implantable device or surgical instrument before delivery of such implantable device or surgical instrument is specifically envisioned. The sheath tip radially expands to more easily accommodate implantable device or surgical instrument volumes and overcome any device or instrument geometry that may tear an elastomeric sleeve. The sheath tip may or may not be accompanied or enhanced by the addition of other materials such as braids, different tubing, or coatings. The elastomeric material, when present, expands such that the implant will be fully or partially encapsulated within the tip. The elastomeric material, when present, also serves to ensure a controlled and consistent expansion of the tip geometry. In addition to the containment of the retrieved device and protection against cut sheath tip areas, the elastomeric material, when present, may extend past the tip of the sheath to form a highly flexible ring that corrects snags, ensuring the successful entry of the device into the sheath tip.
Once the device is retrieved, the material continues to aid in the complete recovery by compressing the implant to facilitate any remaining size discrepancy between the retrieved device and the dimensions of the full length of the sheath. The expandable sheath tip preserves rigidity, column strength, and stiffness where necessary.
In other configurations of introducers or outer sheaths, combinations of the above embodiments are possible. For example, one embodiment includes a high-durometer inner wall with a longitudinally-oriented zig-zag slit, having a cover comprised of a low-durometer braided material. Additionally, the slits may extend the entire length of the introducer sheath or outer shaft so that a device may be pulled through the length of the introducer sheath or outer shaft. Numerous modifications and variations of the present inventions are possible in light of the above teachings. Although the embodiments have been described in detail for the purpose of illustration, it is understood that such detail is solely for that purpose, and variations can be made by those skilled in the art without departing from the spirit and scope of the inventions.
The ascending aorta arises from the aortic orifice from the left ventricle and ascends to become the aortic arch. It is 2 inches long in length and travels with the pulmonary trunk in the pericardial sheath. The branches include the left and right aortic sinuses are dilations in the ascending aorta, located at the level of the aortic valve. They give rise to the left and right coronary arteries that supply the myocardium.
The aortic arch is a continuation of the ascending aorta and begins at the level of the second sternocostal joint. It arches superiorly, posteriorly and to the left before moving inferiorly. The aortic arch ends at the level of the T4 vertebra. There are three major branches arising from the aortic arch. From proximal to distal they include:
Brachiocephalic trunk: The first and largest branch that ascends laterally to split into the right common carotid and right subclavian arteries. These arteries supply the right side of the head and neck, and the right upper limb.
Left common carotid artery: Supplies the left side of the head and neck.
Left subclavian artery: Supplies the left upper limb.
The thoracic aorta or descending aorta spans from the level of T4 to T12. Continuing from the aortic arch, it initially begins to the left of the vertebral column but approaches the midline as it descends. It leaves the thorax via the aortic hiatus in the diaphragm, and becomes the abdominal aorta. The branches include, in descending order:
Bronchial arteries: Paired visceral branches arising laterally to supply bronchial and peribronchial tissue and visceral pleura. However, most commonly, only the paired left bronchial artery arises directly from the aorta whilst the right branches off usually from the third posterior intercostal artery.
Mediastinal arteries: Small arteries that supply the lymph glands and loose areolar tissue in the posterior mediastinum.
Oesophageal arteries: Unpaired visceral branches arising anteriorly to supply the oesophagus.
Pericardial arteries: Small unpaired arteries that arise anteriorly to supply the dorsal portion of the pericardium.
Superior phrenic arteries: Paired parietal branches that supply the superior portion of the diaphragm.
Intercostal and subcostal arteries: Small paired arteries that branch off throughout the length of the posterior thoracic aorta. The 9 pairs of intercostal arteries supply the intercostal spaces, with the exception of the first and second (they are supplied by a branch from the subclavian artery). The subcostal arteries supply the flat abdominal wall muscles.
The abdominal aorta is a continuation of the thoracic aorta beginning at the level of the T12 vertebrae. It is approximately 13 cm long and ends at the level of the L4 vertebra. At this level, the aorta terminates by bifurcating into the right and left common iliac arteries that supply the lower body. The branches of the abdominal aorta are, in descending order:
Inferior phrenic arteries: Paired parietal arteries arising posteriorly at the level of T12. They supply the diaphragm.
Coeliac artery: A large, unpaired visceral artery arising anteriorly at the level of T12. It is also known as the celiac trunk and supplies the liver, stomach, abdominal oesophagus, spleen, the superior duodenum and the superior pancreas.
Superior mesenteric artery: A large, unpaired visceral artery arising anteriorly, just below the celiac artery. It supplies the distal duodenum, jejuno-ileum, ascending colon and part of the transverse colon. It arises at the lower level of L1.
Middle suprarenal arteries: Small paired visceral arteries that arise either side posteriorly at the level of L1 to supply the adrenal glands.
Renal arteries: Paired visceral arteries that arise laterally at the level between L1 and L2. They supply the kidneys.
Gonadal arteries: Paired visceral arteries that arise laterally at the level of L2. Note that the male gonadal artery is referred to as the testicular artery and in females, the ovarian artery.
Inferior mesenteric artery: A large, unpaired visceral artery that arises anteriorly at the level of L3. It supplies the large intestine from the splenic flexure to the upper part of the rectum.
Median sacral artery: An unpaired parietal artery that arises posteriorly at the level of L4 to supply the coccyx, lumbar vertebrae and the sacrum.
Lumbar arteries: There are four pairs of parietal lumbar arteries that arise posterolaterally between the levels of L1 and L4 to supply the abdominal wall and spinal cord.
In various alternative embodiments, the length of an occlusion with perfusion device may be adapted in order to cover one or more branches of an aorta of a patient. The length of the device used to temporarily occlude branches of the aorta is the therapeutic length of the occlusion with perfusion device. The therapeutic effect of temporarily and reversibly occluding one or more branches of the aorta may be accomplished by the among of scaffold covering material applied to the scaffold of the occlusion with perfusion device. These alternatives are applicable to occlusion with perfusion devices having an occlusion with perfusion device and an outer sheath. These alternatives are also applicable to those embodiments where the occlusion with perfusion device and outer sheath are modified to provide a single vascular access point via the lumen of the inner shaft coupled to the occlusion device for a variety of types and sizes of guide catheters, therapeutic catheters, therapeutic devices, vascular prosthesis, implantable devices including transcatheter aortic valves (See
In one aspect, an embodiment of an occlusion with perfusion device may be configured into a number of different therapeutic lengths. The different therapeutic lengths advantageously allow different embodiments of the occlusion with perfusion device to provide selective, temporary occlusion of a variety or mixed combination of branches of the aorta. The therapeutic length for a particular occlusion with perfusion device will depend on the clinical scenario in which the device is employed. In one exemplary configuration, an occlusion with perfusion device may be used to selectively, temporarily and reversibly occlude the renal arteries. In another exemplary configuration, an occlusion with perfusion device may be used to selectively, temporarily and reversibly occlude some or all of the aorta branches in the abdominal aorta. Such an occlusion with perfusion device may have a length from a proximal end that is superior to the iliac split and a distal end that is at or inferior to the diaphragm. In still another exemplary configuration, an occlusion with perfusion device may be used to selectively, temporarily and reversibly occlude some or all of the aorta branches in the thoracic and abdominal aorta. Such an occlusion with perfusion device may have a length from a proximal end that is superior to the iliac split and a distal end that is at or inferior to the diaphragm.
Exemplary Therapeutic Length 1
Exemplary Therapeutic Length 2
Exemplary Therapeutic Length 3
In one illustrative example, the occlusion with perfusion device would have a length from a proximal end that is superior to the iliac split and a distal end that is at or superior to the diaphragm. In the case where the device is intended to selectively, temporarily and reversibly occlude the renal arteries and those within a portion of both the abdominal aorta and the thoracic aorta, the length of the device would be about 17 cm or in a range of about 15 cm to about 19 cm. In one possible deployment scenario within the aorta for selective and temporary occlusion of the renal arteries and branches of the abdominal aorta, the celiac trunk and the thoracic aorta, the distal end of the device is position at or near vertebra T6. In this position, a device with this therapeutic length when the device is deployed into an occlusion with distal profusion configuration, a portion of the covering that is unattached to the scaffold structure will distend into the opening of the renal arteries and one or more of the branch vessels of the abdominal aorta and/or the celiac trunk and/or branch vessels of the thoracic aorta. In addition to the branch vessels mentioned above, the device may also be used to selectively and temporarily occlude one or more of the branch vessels superior to the aortic hiatus and inferior to the aortic arch.
In each of these various therapeutic lengths, it is to be appreciated that the amount or percentage of the scaffold device that is covered, the location of the covering on the device relative to a likely branch vessel location when deployed as well as the relative size and number of branch openings are each one different design attributes for various alternatives. In still other alternatives, the device may be covered along the entire length and deployed in a general way as an emergency occlusion device when a length of the aorta or branch vessel has been damaged. In this way, a device of therapeutic length 1 may be used but instead of directing delivery to the renal arteries, delivery is guided to the injured or suspected injured branch vessel or portion of the aorta. In a similar way, therapeutic lengths 2 and 3 may be similarly employed should the zone of damage to the aorta or the number of branches involved require temporary occlusion in support of repairs to the damaged aorta or damaged branch vessel or vessels.
Additionally or alternatively, the different lengths of the device may be employed to protect other organs or portions of the body from harmful materials similar to the way that the temporary occlusion of the renal arteries during contrast injection aids in preventing harm to the kidneys. As such, by temporarily occluding one or more branch vessels of the abdominal aorta, celiac trunk or thoracic aorta, reduced exposure of those organs or body functions supported by the aorta may also be provided. In still other alternative clinical scenarios, a patient who is undergoing chemotherapy may also benefit from the use of an embodiment of a temporary occlusion device to prevent chemotherapeutic agents from being carried into the organs and functions supplied by the abdominal aorta, celiac trunk or thoracic aorta.
In still other aspects, an occlusion with perfusion device may also have sections where the cover material or configuration may vary depending upon the clinical scenario and the grouping of branch vessels to be temporarily and reversibly occluded. As a result, there are also provided occlusion with perfusion device embodiments having one or more or a combination of: continuous scaffold sections that are uncovered, discontinuous scaffold covering sections, scaffold coverings including pressure relief features (
In embodiments of the single point vascular access device adapted for combined use with TAVR delivery, the outer sheath and the occlusion with perfusion device and associated guide catheter are adapted to accommodate the size of the particular device being implanted. As described elsewhere, the occlusion with perfusion device operates to protect the kidneys from damage by temporarily occluding the renal arteries when contrast is used. Other organs may also be protected from potential damage from contrast exposure by selecting an occlusion with perfusion device of an appropriate therapeutic length for those organs to be protected.
First, at step 7310, there is the step of advancing an at least partially covered scaffold structure occlusion device to a portion of an aorta to be occluded while the scaffold structure is attached to a handle outside of the patient. This step may be further understood by reference to
Next, at step 7320, there is the step of using the handle outside of the patient to deploy the at least partially covered scaffold structure occlusion device within the aorta to reversibly occlude partially or completely one or more peripheral vessels or a combination of peripheral vessels of the aorta along a first therapeutic length, a second therapeutic length or a third therapeutic length. This step is performed by appropriate manipulation of a handle embodiment described herein according to the disclosure related to
Next, at step 7330, there is the step of allowing blood perfusion flow through the at least partially covered scaffold structure to distal vessels and structures.
Next, at step 7340, there is a step of distending an unattached portion of the scaffold covering in response to blood flow through the scaffold structure to reversibly occlude partially or completely one or more peripheral vessels or a combination of peripheral vessels of the aorta within the first therapeutic length, the second therapeutic length or the third therapeutic length. This step may be appreciated by way of illustration and not limitation the additional details of
Next, at step 7350, there is a step of restoring blood flow to partially or fully occluded vessels by using the handle outside of the patient for transitioning the partially covered scaffold structure into a stowed condition within an outer sheath or between an outer sheath inner wall and a guide catheter outer wall. Aspects of the details of this step may be appreciated by reference to
Next, at step 7360, there is a step of repeating steps 7320, 7330, 7430 as needed for reversibly occluding within the first therapeutic length, the second therapeutic length or the third therapeutic length or transition into the stowed condition of step 7350 using the handle outside of the patient and removing the stowed scaffold structure from the patient vasculature using the handle that is tethered to the scaffold structure.
First, at step 7410 there is a step of advancing a stowed vascular occlusion device into an abdominal aorta of a patient who has or will receive injections of radiological contrast during a cardiovascular procedure performed using a lumen of the shaft of the occlusion device. This step may be further understood by reference to
Next, at step 7420, there is a step of transitioning the vascular occlusion device from the stowed condition to a deployed condition using a handle outside of the patient and attached to the occlusion device and advancing a guide catheter through the lumen of the shaft of the occlusion device. This step may be further understood with reference to
Next, at step 7430, there is a step of directing the blood flow in the supra-renal portion of the aorta containing radiological contrast into the lumen of the vascular occlusion device to prevent blood flow entering the renal arteries while allowing perfusion of the distal arterial vasculature. This step may be further understood with reference to
Next, at step 7440, there is a step distending a portion of a multiple layer membrane of the vascular occlusion device outwardly from the scaffold structure in response to arterial blood flow so that the distended portion of the multiple layer membrane at least partially occludes an ostia of a renal artery. This step may be further understood with reference to
Next, at step 7450, when perfusion with occlusion protection of the renal arteries is concluded, the vascular occlusion device is transitioned back into the stowed condition against an outer wall of the guide catheter until (a) steps 7420, 7430 and 7440 are repeated during additional uses of contrast during the vascular procedure performed using the lumen of the occlusion device shaft OR (b) the stowed occlusion device may be removed from the patient using the handle outside of the patient and attached to the vascular occlusion device. This step may be further understood by reference to
First, at step 7510, there is the step of advancing a vascular occlusion device in a stowed condition along a blood vessel to a position adjacent to one or more peripheral blood vessels selected for occlusion while the device is tethered to a handle outside of the patient. This step may be further understood by reference to
Next, at step 7520, there is the step of transitioning the vascular occlusion device from a stowed condition within a pocket of a dilator to a deployed condition wherein the vascular occlusion at least partially occludes blood flow into the one or more peripheral blood vessels selected for occlusion. This step may be further appreciated by reference to
Next, at step 7530, there is the step of withdrawing the dilator from the vascular occlusion device shaft lumen. This step may be appreciated by specific reference to
Next, at step 7540, there is the step of advancing a guide catheter through the vascular occlusion device shaft lumen to a position beyond the distal end of the occlusion device. This step may be appreciated by reference to
Next, at step 7550, there is the step of restoring blood flow into the one or more peripheral blood vessels selected for occlusion by transitioning the vascular occlusion device out of the deployed condition into a stowed condition between an inner wall of an outer shaft and an outer wall of the guide catheter. This step may be appreciated by reference to
Next, at step 7560, during a vascular procedure performed using access provided by the guide catheter within the occlusion device, protecting an organ or structures of the one or more blood vessels from exposure to contrast used during the vascular procedure by transitioning the vascular occlusion device out of the stowed condition into a deployed condition to occlude blood flow into the one or more peripheral blood vessels selected for temporary and reversible occlusion using the vascular occlusion device. The benefits of this step and the protection of various organs and structures may be appreciated with reference to
Finally, at step 7570, there is a step of transitioning the vascular occlusion device into the stowed condition and withdrawing the vascular occlusion device from the patient using the handle tethered to the vascular occlusion device when the vascular procedure is completed.
First, at step 7610, there is the step of advancing a vascular occlusion device in a stowed condition along a blood vessel to a position adjacent to one or more peripheral blood vessels selected for occlusion while the device is tethered to a handle outside of the patient.
Next, at step 7620, there is the step of transitioning the vascular occlusion device from a stowed condition within an expandable distal end of an outer sheath to a deployed condition wherein the vascular occlusion at least partially occludes blood flow into the one or more peripheral blood vessels selected for occlusion. Exemplary embodiments related to the expandable section of an outer sheath include, by way of example and not limitation, those described with regard to
Next, at step 7630, there is the step of advancing a guide catheter through the vascular occlusion device shaft lumen to a position beyond the distal end of the occlusion device. This step may be appreciated by reference to
Next, at step 7640, there is the step of restoring blood flow into the one or more peripheral blood vessels selected for occlusion by transitioning the vascular occlusion device out of the deployed condition into a stowed condition between a distended portion of the expandable distal end of the outer sheath and an outer wall of the guide catheter. This step may be appreciated with reference, for example, to
Next, at step 7650, during a vascular procedure performed using access provided by the guide catheter within the occlusion device, protecting an organ or structures of the one or more blood vessels from exposure to contrast used during the vascular procedure by withdrawing the outer sheath and transitioning the vascular occlusion device out of the stowed condition into a deployed condition to occlude blood flow into the one or more peripheral blood vessels selected for temporary and reversible occlusion using the vascular occlusion device. This step may be accomplished by reversing the direction of movement in
Finally, at step 7660, there is a step of transitioning the vascular occlusion device into the stowed condition and withdrawing the vascular occlusion device from the patient using the handle tethered to the vascular occlusion device when the vascular procedure is completed.
Exemplary Combination Vascular Access and Occlusion with Perfusion Devices
The various alternative configurations and capabilities of the perfusion with occlusion device and combination occlusion with access device may be sized for a variety of applications and different vascular procedures. In one aspect, for example, sizes ranging from 5 Fr to 8 Fr (0.065 to 0.105 inches) when used for occlusion with perfusion alone and from 6 Fr to 24 Fr (0.079-0.315 inches) when used as a combination occlusion with perfusion and vascular access device. Additionally, the occlusion device shaft lumen may also be sized based on when used alone or in a combination product for vascular access. When used alone, the lumen of the occlusion device shaft may range from 4 Fr to 7 Fr (0.053 to 0.092 inches) When used in a combination occlusion and vascular access product the lumen size will be increased to allow access to a range of different sized guide catheters. In this case, the lumen will range from 5 Fr to 22 Fr (0.066-0.288 inches)
Advantageously, a dilator may also be used which has been modified to provide a pocket sized to hold an occlusion with perfusion device in a stowed configuration to further decrease the profile—size of the combination device during introduction to the vasculature. The dilator pocket may have a length of about 10 cm, or a range of 5 cm to 40 cm, for the recessed portion of the dilator used to hold the occlusion device. The recessed outer diameter will be about 0.035 inches, with a range of 0.035 to 0.050 inches. The recessed portions inner diameter will be about 0.021 inches, with a range of 0.021 inches and 0.040 inches. (See
Various exemplary embodiments of the invention are described herein. Reference is made to these examples in a non-limiting sense. They are provided to illustrate more broadly applicable aspects of the invention. Various changes may be made to the invention described and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the present invention. Further, as will be appreciated by those with skill in the art that each of the individual variations described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present inventions. All such modifications are intended to be within the scope of claims associated with this disclosure.
Any of the devices described for carrying out the subject diagnostic or interventional procedures may be provided in packaged combination for use in executing such interventions. These supply “kits” may further include instructions for use and be packaged in sterile trays or containers as commonly employed for such purposes.
The invention includes methods that may be performed using the subject devices. The methods may comprise the act of providing such a suitable device. Such provision may be performed by the end user. In other words, the “providing” act merely requires the end user obtain, access, approach, position, set-up, activate, power-up or otherwise act to provide the requisite device in the subject method. Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as in the recited order of events.
Exemplary aspects of the invention, together with details regarding material selection and manufacture have been set forth above. As for other details of the present invention, these may be appreciated in connection with the above-referenced patents and publications as well as generally known or appreciated by those with skill in the art. For example, one with skill in the art will appreciate that one or more lubricious coatings (e.g., hydrophilic polymers such as polyvinylpyrrolidone-based compositions, fluoropolymers such as tetrafluoroethylene, hydrophilic gel or silicones) may be used in connection with various portions of the devices, such as relatively large interfacial surfaces of movably coupled parts, if desired, for example, to facilitate low friction manipulation or advancement of such objects relative to other portions of the instrumentation or nearby tissue structures. The same may hold true with respect to method-based aspects of the invention in terms of additional acts as commonly or logically employed.
In addition, though the invention has been described in reference to several examples optionally incorporating various features, the invention is not to be limited to that which is described or indicated as contemplated with respect to each variation of the invention. Various changes may be made to the invention described and equivalents (whether recited herein or not included for the sake of some brevity) may be substituted without departing from the true spirit and scope of the invention. In addition, where a range of values is provided, it is understood that every intervening value, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the invention.
Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein. Reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in claims associated hereto, the singular forms “a,” “an,” “said,” and “the” include plural referents unless the specifically stated otherwise. In other words, use of the articles allow for “at least one” of the subject item in the description above as well as claims associated with this disclosure. It is further noted that such claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.
Without the use of such exclusive terminology, the term “comprising” in claims associated with this disclosure shall allow for the inclusion of any additional element—irrespective of whether a given number of elements are enumerated in such claims, or the addition of a feature could be regarded as transforming the nature of an element set forth in such claims. Except as specifically defined herein, all technical and scientific terms used herein are to be given as broad a commonly understood meaning as possible while maintaining claim validity.
The breadth of the present invention is not to be limited to the examples provided and/or the subject specification, but rather only by the scope of claim language associated with this disclosure.
When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. 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 “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.
Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
Although preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein can be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.
This application claims priority to U.S. Provisional Patent Application No. 62/984,189 filed Mar. 2, 2020, titled “INTRODUCER HAVING CONTROLLABLE OCCLUSION WITH PERFUSION CAPABILITIES,” which is herein incorporated by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US21/20550 | 3/2/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62984189 | Mar 2020 | US |
