Patent Grant
9993360
This present application relates generally to prostheses and surgical methods, and specifically to tubular prostheses, including endovascular stent-grafts, and surgical techniques for using the prostheses to maintain patency of body passages such as blood vessels, and treating aneurysms and dissections of arterial walls.
Endovascular prostheses are sometimes used to treat aortic aneurysms. Such treatment includes implanting a stent or stent-graft within the diseased vessel to bypass the anomaly. An aneurysm is a sac formed by the dilation of the wall of the artery. Aneurysms may be congenital, but are usually caused by disease or, occasionally, by trauma. Aortic aneurysms which commonly form between the renal arteries and the iliac arteries are referred to as abdominal aortic aneurysms (“AAAs”). Other aneurysms occur in the aorta, such as thoracic aortic aneurysms (“TAAs”), which may occur in one or more of the descending aorta, the ascending aorta, and the aortic arch.
Endo-Vascular Aneurysm Repair (EVAR) has transformed the practice of treatment of aortic aneurysms from an open surgical approach to a much less invasive surgical approach. The first step of an endovascular intervention usually requires introducing a delivery system into the vasculature of a patient. If the crossing profile, i.e., the external diameter, of the delivery system is 24 Fr or lower (3 Fr=1 millimeter), a true percutaneous approach may be used, because vascular closure devices are available for proper closure of such puncture sites.
Some embodiments of the present invention provide an endovascular system, which comprises an endovascular implant and a delivery tool. The delivery tool is configured to minimize or prevent migration of the endovascular implant during an implantation procedure. The delivery tool comprises a proximal main delivery catheter, which has a distal portion in which the implant is initially disposed while in a radially-compressed delivery state. The delivery tool further comprises a distal restraining assembly, which comprises a restraining-assembly tubular shaft disposed distal to the proximal main delivery catheter. The distal restraining assembly is configured to assume (a) an engaged state, in which the distal restraining assembly prevents proximal displacement of the implant relative to the distal restraining assembly, and (b) a disengaged state, in which the distal restraining assembly does not engage the implant.
For some applications, the distal restraining assembly comprises one or more flexible elongated members, such as sutures, wires, or strings. The flexible elongated members extend from a proximal end of the restraining-assembly tubular shaft. When the distal restraining assembly is in the engaged state, the flexible elongated members releasably couple the distal restraining assembly to a distal portion of the implant.
Typically, the delivery tool further comprises a tip disposed longitudinally between the proximal main delivery catheter and the restraining-assembly tubular shaft. When the implant is in the radially-expanded deployment state and the distal restraining assembly is in the engaged state, the tip is proximally withdrawable into the implant without entangling the tip with the flexible elongated members. Typically, the flexible elongated members pass over an external surface of the tip when the distal restraining assembly is in the engaged state. The flexible elongated members are slidably disposed within the restraining-assembly tubular shaft, at least when the distal restraining assembly is in the engaged state. For some applications, the tip is conically shaped. Typically, the tip narrows toward a distal end thereof.
Typically, the endovascular system further comprises a guidewire. The delivery tool is configured to receive the guidewire therethrough, typically such that the guidewire extends from a proximal end of the proximal main delivery catheter to a distal end of the restraining-assembly tubular shaft, at least when the distal restraining assembly is in the engaged state. Typically, the proximal main delivery catheter and the restraining-assembly tubular shaft are shaped so as to define respective guidewire longitudinal lumens therethrough.
In some applications of the present invention, during a first stage of an implantation procedure, the guidewire of the delivery tool is endovascularly (preferably percutaneously) introduced into the vasculature at a first vascular access site, advanced through the vasculature, and extracted from the vasculature and the patient's body at a second vascular access site different from the first. Alternatively, the guidewire is endovascularly introduced into the vasculature at the second vascular access site, advanced through the vasculature towards the first vascular access site, captured and thereafter extracted from the vasculature and the patient's body at the first vascular access site. In either case, the guidewire extends between two vascular access sites through the vasculature. The distal restraining assembly and the proximal main delivery catheter are introduced, through the first vascular access site, into the vasculature over the guidewire. Typically, the restraining-assembly tubular shaft is advanced over the guidewire until a distal end of the restraining-assembly tubular shaft exits the vasculature through the second vascular access site, and the distal end is held (e.g., fixed and/or secured) stationary outside the patient's body. (As used in the present application, including in the claims, “fixing” or “securing” the distal end should not be understood to mean permanently fixing or securing the distal end; the distal end is in fact released later in the implantation procedure.) The restraining-assembly tubular shaft of the distal restraining assembly is positioned distal to the proximal main delivery catheter. The distal restraining assembly is in the engaged state at this stage of the implantation procedure. The tip of the delivery tool is disposed longitudinally between the proximal main delivery catheter and the restraining-assembly tubular shaft.
Respective first portions of the flexible elongated members of the distal restraining assembly extend from the proximal end of the restraining-assembly tubular shaft, and thus pass through the second vascular access site together with (within) the restraining-assembly tubular shaft, and thus are accessible from outside the patient's body. In addition, the flexible elongated members are positioned such that they pass through the restraining-assembly tubular shaft, pass over the external surface of the tip, and are releasably coupled to the distal portion of the implant.
The proximal main delivery catheter (and the distal restraining assembly) is advanced through the vasculature to a desired deployment site. The implant is released from the proximal main delivery catheter in the vasculature. The implant radially expands and transitions to the radially-expanded deployment state as it is released.
At this stage of the implantation procedure, the distal restraining assembly is still in the engaged state, in which the distal restraining assembly prevents proximal displacement of the implant relative to the distal restraining assembly. A distal end of the restraining-assembly tubular shaft is held (e.g., fixed and/or secured) stationary outside the second vascular access site, which prevents proximal movement of the restraining-assembly tubular shaft and the remainder of the distal restraining assembly, including the flexible elongated members, and thus the implant. Without using such techniques for preventing proximal movement, the implant sometimes migrates during a subsequent step of the implantation procedure, such as the advancement of one or more second implants through the implant. In addition, device motion may increase the risk of stroke.
The tip is proximally withdrawn into and through the implant. The proximal main delivery catheter is proximally withdrawn from the vasculature through the first vascular access site. At this stage of the implantation procedure, the flexible elongated members remain coupled to the distal portion of the implant. Because the flexible elongated members passed outside of the tip during the earlier stages of the procedure, the flexible elongated members do not become entangled with or otherwise interfere with the proximal withdrawal of the tip.
After the first stent-graft is released from the proximal main delivery catheter, while the distal end of the restraining-assembly tubular shaft is held (e.g., fixed and/or secured) stationary outside the second vascular access site, and before the distal restraining assembly is transitioned to the disengaged state, one or more second endovascular implants are introduced into the vasculature. The one or more second implants are advanced at least partially through the first implant, such as through a lateral opening defined by the first implant, and deployed in the vasculature. The one or more second implants are typically introduced over one or more second guidewires, separate from the guidewire over which the first implant was introduced, which typically remains in place in the vasculature during the deployment of the one or more second implants.
After deployment of the one or more second endovascular implants, the distal restraining assembly is transitioned to the disengaged state, in which the distal restraining assembly allows proximal displacement of the implant relative to the distal restraining assembly. For some applications, in order to disengage the distal restraining assembly, distal portions of the flexible elongated members that extend beyond the distal end of the restraining-assembly tubular shaft are cut, in order to release the flexible elongated members from the distal portion of the implant.
There is therefore provided, in accordance with an application of the present invention, apparatus including an endovascular system, which includes:
an endovascular implant, which is configured to assume a radially-compressed delivery state, and a radially-expanded deployment state; and
a delivery tool, which includes:
For some applications, the distal restraining assembly includes one or more flexible elongated members, which extend from a proximal end of the restraining-assembly tubular shaft and releasably couple an element of the endovascular system to a distal portion of the implant when the distal restraining assembly is in the engaged state, the element selected from the group consisting of: the distal restraining assembly and the restraining-assembly tubular shaft. For some applications, the endovascular implant includes a stent member, and the flexible elongated members releasably couple the selected element of the endovascular system to a distal portion of the stent member when the distal restraining assembly is in the engaged state.
For some applications, the delivery tool further includes a tip disposed longitudinally between the proximal main delivery catheter and the restraining-assembly tubular shaft, and, when the implant is in the radially-expanded deployment state and the distal restraining assembly is in the engaged state, the tip is proximally withdrawable into the implant without entangling the tip with the flexible elongated members. For some applications, the flexible elongated members pass over an external surface of the tip when the distal restraining assembly is in the engaged state. For some applications, the external surface of the tip is shaped so as to define one or more grooves, and the flexible elongated members are disposed within the grooves while the flexible elongated members pass over the external surface.
For some applications, the restraining-assembly tubular shaft is shaped so as to define one or more longitudinal elongated-member lumens therethrough, through which the flexible elongated members are slidably disposed at least when the distal restraining assembly is in the engaged state. For some applications, the endovascular system further includes a guidewire, and the restraining-assembly tubular shaft is shaped so as to further define a longitudinal guidewire lumen therethrough, through which the guidewire is removably disposed. For some applications, the guidewire lumen is disposed along a central longitudinal axis of the restraining-assembly tubular shaft.
For any of the applications described above, when the endovascular implant is disposed within the proximal main delivery catheter of the delivery tool in the radially-compressed delivery state, a first longitudinal portion of the delivery tool may extend between a proximal end of the implant and a proximal end of the delivery tool, a second longitudinal portion of the delivery tool may extend between a distal end of the implant and a distal end of the delivery tool, and the first and the second longitudinal portions may have respective lengths, each of which is at least 20 cm.
For any of the applications described above, the distal restraining assembly may be configured to provide a distal disengagement site at a distal location on the restraining-assembly tubular shaft, from which site the distal restraining assembly is transitionable from the engaged state to the disengaged state.
For any of the applications described above, the delivery tool may further include a tip disposed longitudinally between the proximal main delivery catheter and the restraining-assembly tubular shaft. For some applications, the proximal main delivery catheter includes inner and outer tubular shafts, and the tip is fixed to a distal end of the inner shaft. For some applications, the tip is conically shaped. For some applications, the proximal main delivery catheter includes inner and outer tubular shafts, and the tip gradually tapers from (a) a proximal-end diameter equal to between 90% and 110% of an outer diameter of a distal end of the outer tubular shaft to (b) a distal-end diameter equal to between 70% and 100% of an outer diameter of the proximal end of the restraining-assembly tubular shaft.
For any of the applications described above, the proximal main delivery catheter may include inner and outer tubular shafts, which are longitudinally translatable with respect to each other, and the implant may be disposed radially between the inner and the outer shafts while in the radially-compressed delivery state. For some applications, the delivery tool is configured such that proximal longitudinal translation of the outer shaft relative to the inner shaft transitions the implant from the radially-compressed delivery state to the radially-expanded deployment state. For some applications, the proximal main delivery catheter includes a stopper member, which is disposed between the inner and the outer shafts, and is fixed to exactly one of the inner and the outer shafts. For some applications, the endovascular implant includes a stent member, and the stopper member is shaped and sized to interface with the stent member while the implant is in its radially-compressed delivery state, thereby substantially preventing proximal translation of the implant relative to the inner shaft as the outer shaft is proximally translated relative to the inner shaft. For some applications, the stopper member is fixed to the inner shaft. For some applications, the stopper member is positioned adjacent a distal end of the implant while the implant is in the radially-compressed delivery state, disposed radially between the inner and the outer shafts.
For any of the applications described above, the endovascular implant may include a stent-graft, which includes a flexible stent member, and a generally tubular fluid flow guide, which is securely attached to and covers at least a portion of the stent member. For some applications, the stent-graft is shaped so as to define at least one lateral opening. For some applications, the stent-graft is a first stent-graft, and the endovascular system further includes a second stent-graft, which is sized to pass at least partially through the lateral opening. For some applications, the opening is generally circular. For some applications, the stent-graft is bifurcated, and is shaped so as to define a distal main lumen, which bifurcates into two proximal branching lumens. For some applications, a length of a first one of the branching lumens is less than 90% of a length of a second one of the branching lumens. Alternatively, a length of a first one of the branching lumens is at least 10% greater than a length of a second one of the branching lumens.
For any of the applications described above, the endovascular system may further include a guidewire, and the delivery tool may be configured to receive the guidewire therethrough. For some applications, the delivery tool is configured to receive the guidewire therethrough such that the guidewire extends from a proximal end of the proximal main delivery catheter to a distal end of the restraining-assembly tubular shaft. For some applications, the proximal main delivery catheter and the restraining-assembly tubular shaft are shaped so as to define respective guidewire longitudinal lumens therethrough. For some applications, the proximal main delivery catheter includes inner and outer tubular shafts, and the inner shaft is shaped so as to define the guidewire longitudinal lumen of the proximal main delivery catheter. For some applications, the guidewire longitudinal lumen of the restraining-assembly tubular shaft is disposed along a central longitudinal axis of the restraining-assembly tubular shaft.
For any of the applications described above, the endovascular system may further include a guidewire, and the restraining-assembly tubular shaft may be shaped so as to define a longitudinal guidewire lumen therethrough, through which the guidewire is removably disposed. For some applications, the guidewire is a first guidewire, and the endovascular system includes a second guidewire.
For any of the applications described above, the endovascular implant may include a flexible stent member that includes a plurality of structural stent elements axially separate from one another.
For any of the applications described above, the distal restraining assembly may further include one or more release effector flexible elongated members, which pass from a proximal end to a distal end of the restraining-assembly tubular shaft through one or more longitudinal elongated-member lumens within the restraining-assembly tubular shaft. For some applications, the one or more release effector flexible elongated members securely engage the endovascular implant when the distal restraining assembly is in the engaged state. For some applications, the endovascular implant includes a flexible stent member, and the one or more release effector flexible elongated members securely engage the stent member when the distal restraining assembly is in the engaged state. For some applications, the endovascular implant includes a stent-graft, which includes a flexible stent member, and a generally tubular fluid flow guide, which is securely attached to and covers at least a portion of the stent member, and the release effector flexible elongated members securely engage the fluid flow guide when the distal restraining assembly is in the engaged state. For some applications, the release effector flexible elongated members are disengaged from the implant when the distal restraining assembly is in the disengaged state.
For some applications, the one or more release effector flexible elongated members pass from the distal end of the restraining-assembly tubular shaft to the proximal end of the restraining-assembly tubular shaft, engage the endovascular implant, and return to the distal end of the restraining-assembly tubular shaft, and distally extracting respective first ends of the release wires transitions the distal restraining assembly from the engaged state to the disengaged state. For some applications, the one or more release effector flexible longitudinal members are configured to transition the distal restraining assembly from the engaged state to the disengaged state by rotation of each of the flexible longitudinal members around a longitudinal axis thereof.
There is additionally provided, in accordance with an application of the present invention, apparatus including an endovascular stent-graft:
a flexible stent member; and
a tubular fluid flow guide, which includes:
For some applications, the first material is less thrombogenic than the second material. For some applications, the second material is less deformable than the first material.
For some applications:
the stent-graft is configured to assume a radially-compressed delivery state and a radially-expanded deployment state,
the stent-graft has first and second ends,
a perimeter of the stent-graft at the first end is less than a perimeter of the stent-graft at the second end, when the stent-graft is in the radially-expanded deployment state, and
the first longitudinal portion extends to the first end of the stent-graft.
For some applications:
the stent-graft is a fenestrated stent-graft,
the apparatus further includes a main stent-graft, which is shaped so as to define a lateral opening, and
the second longitudinal portion of the fenestrated stent-graft is shaped so as to define an interface portion configured to form a blood-tight seal with the lateral opening of the main stent-graft.
For some applications, the first material includes expanded polytetrafluoroethylene (ePTFE).
For any of the applications described above, the second material may include a polyester.
For any of the applications described above, the first and the second longitudinal portions may be non-longitudinally-overlapping. For some applications, the first and the second longitudinal portions are longitudinally adjacent each other. For some applications, the first and the second fabrics are coupled to each other at a longitudinal junction between the first and the second longitudinal portions.
For any of the applications described above, the first and the second longitudinal portions may be partially longitudinally overlapping along a longitudinally overlapping portion of the stent-graft. For some applications, the first and the second fabrics are coupled to each other at one or more locations along the longitudinally overlapping portion. For some applications, the longitudinally overlapping portion of the stent-graft has a length that is less than 5% of an overall length of the stent-graft. For some applications, the longitudinally overlapping portion of the stent-graft has a length of between 2 and 10 mm. For some applications, the longitudinally overlapping portion of the stent-graft is positioned at a location along the stent-graft that has a diameter that is less than a greatest diameter of the stent-graft.
There is yet additionally provided, in accordance with an inventive concept 1 of the present invention, a method comprising:
providing (a) an endovascular implant and (b) a delivery tool which includes a proximal main delivery catheter and a distal restraining assembly, which includes a restraining-assembly tubular shaft disposed distal to the proximal main delivery catheter;
endovascularly introducing the delivery tool into vasculature of a patient through a first vascular access site, while the endovascular implant is disposed in a radially-compressed delivery state within a distal portion of the proximal main delivery catheter, and while the distal restraining assembly is in an engaged state with the endovascular implant, in which state the distal restraining assembly prevents proximal movement of the implant relative to the distal restraining assembly;
advancing the delivery tool through the vasculature until a distal end of the restraining-assembly tubular shaft exits the vasculature and a body of the patient through a second vascular access site;
releasing the endovascular implant from the proximal main delivery catheter, such that the endovascular implant transitions to a radially-expanded deployment state in the vasculature;
thereafter, transitioning the distal restraining assembly to a disengaged state, in which state the distal restraining assembly does not engage the implant; and
thereafter, extracting the distal restraining assembly from the vasculature and the body of the patient through the second vascular access site.
Inventive concept 2. The method according to inventive concept 1, wherein endovascularly introducing and advancing the delivery tool comprise:
endovascularly introducing a guidewire of the delivery tool through one of the first and the second vascular access sites into the vasculature;
advancing the guidewire through the vasculature to the other of the first and the second vascular access sites;
extracting a portion of the guidewire from the vasculature and the body of the patient through the other of the first and the second vascular access sites, such that the guidewire extends between the first and the second vascular access sites through the vasculature; and endovascularly introducing and advancing the delivery tool over the guidewire until the distal end of the restraining-assembly tubular shaft exits the vasculature and the body of the patient through the second vascular access site.
Inventive concept 3. The method according to inventive concept 2,
wherein the distal restraining assembly includes one or more flexible elongated members, which extend from a proximal end of the restraining-assembly tubular shaft and releasably couple the distal restraining assembly to a distal portion of the implant when the distal restraining assembly is in the engaged state,
wherein the restraining-assembly tubular shaft is shaped so as to define one or more longitudinal elongated-member lumens and a longitudinal guidewire lumen therethrough, and
wherein endovascularly introducing the delivery tool comprises endovascularly introducing the delivery tool while the flexible elongated members are slidably disposed through the longitudinal elongated-member lumens, and the guidewire is removably disposed through the longitudinal guidewire lumen.
Inventive concept 4. The method according to inventive concept 2, further comprising, after releasing the endovascular implant from the proximal main delivery catheter, using the guidewire to help hold the implant in place in the vasculature.
Inventive concept 5. The method according to inventive concept 1, further comprising fixing the distal end of the restraining-assembly tubular shaft stationary outside the second vascular access site, such that the distal restraining assembly prevents proximal displacement of the implant relative to the distal restraining assembly.
Inventive concept 6. The method according to inventive concept 5, wherein fixing stationary comprises fixing the distal end of the restraining-assembly tubular shaft stationary before releasing the endovascular implant from the proximal main delivery catheter.
Inventive concept 7. The method according to inventive concept 5, wherein fixing stationary comprises fixing the distal end of the restraining-assembly tubular shaft stationary after releasing the endovascular implant from the proximal main delivery catheter.
Inventive concept 8. The method according to inventive concept 1, further comprising, after releasing the endovascular implant, pulling the distal end of the restraining-assembly tubular shaft distally from outside the second vascular access site, thereby distally displacing the endovascular implant.
Inventive concept 9. The method according to inventive concept 1, further comprising, after releasing the endovascular implant, rotating the distal restraining assembly from outside the second vascular access site, thereby rotating the endovascular implant.
Inventive concept 10. The method according to inventive concept 9, wherein rotating the distal restraining assembly comprises rotating the restraining-assembly tubular shaft from outside the second vascular access site.
Inventive concept 11. The method according to inventive concept 1,
wherein the distal restraining assembly includes one or more flexible elongated members, which extend from a proximal end of the restraining-assembly tubular shaft and releasably couple the distal restraining assembly to a distal portion of the implant when the distal restraining assembly is in the engaged state, and
wherein advancing the delivery tool through the vasculature until the distal end of the restraining-assembly tubular shaft exits the vasculature through the second vascular access site comprises passing the flexible elongated members through the second vascular access site together with the distal end of the restraining-assembly tubular shaft, such that the flexible elongated members are accessible from outside a body of the patient.
Inventive concept 12. The method according to inventive concept 11, wherein endovascularly introducing the delivery tool comprises endovascularly introducing the delivery tool while the flexible elongated members releasably couple the distal restraining assembly to a distal portion of the endovascular implant, while the distal restraining assembly is in the engaged state.
Inventive concept 13. The method according to inventive concept 11, wherein transitioning the distal restraining assembly to the disengaged state comprises cutting distal portions of the flexible elongated members that extend beyond the distal end of the restraining-assembly tubular shaft.
Inventive concept 14. The method according to inventive concept 11,
wherein the delivery tool further includes a tip, and
wherein endovascularly introducing the delivery tool comprises endovascularly introducing the delivery tool while the tip is disposed longitudinally between the proximal main delivery catheter and the restraining-assembly tubular shaft.
Inventive concept 15. The method according to inventive concept 14, wherein releasing the endovascular implant from the proximal main delivery catheter further comprises, after the implant transitions to the radially-expanded deployment state, proximally withdrawing the tip into the implant without entangling the tip with the flexible elongated members.
Inventive concept 16. The method according to inventive concept 14, wherein providing the delivery tool comprises providing the delivery tool in which the proximal main delivery catheter includes inner and outer tubular shafts, and the tip is fixed to a distal end of the inner shaft.
Inventive concept 17. The method according to inventive concept 14, wherein providing the delivery tool comprises providing the delivery tool in which the proximal main delivery catheter comprises inner and outer tubular shafts, and the tip gradually tapers from (a) a proximal-end circumference equal to between 90% and 110% of an outer circumference of a distal end of the outer tubular shaft to (b) a distal-end circumference equal to between 70% and 100% of an outer circumference of the proximal end of the restraining-assembly tubular shaft.
Inventive concept 18. The method according to inventive concept 14, wherein endovascularly introducing the delivery tool comprises endovascularly introducing the delivery tool while the flexible elongated members pass over an external surface of the tip, while the distal restraining assembly is in the engaged state.
Inventive concept 19. The method according to inventive concept 14, wherein the external surface of the tip is shaped so as to define one or more grooves, and wherein endovascularly introducing the delivery tool comprises endovascularly introducing the delivery tool while the flexible elongated members are disposed within the grooves while the flexible elongated members pass over the external surface.
Inventive concept 20. The method according to inventive concept 1, wherein transitioning the distal restraining assembly to the disengaged state comprises transitioning the distal restraining assembly to the disengaged state from a distal disengagement site provided by the distal restraining assembly at a distal location on the restraining-assembly tubular shaft.
Inventive concept 21. The method according to inventive concept 1, wherein providing the endovascular implant comprises providing a stent-graft, which comprises a flexible stent member, and a generally tubular fluid flow guide, which is securely attached to and covers at least a portion of the stent member.
Inventive concept 22. The method according to inventive concept 21,
wherein the stent-graft is a first stent-graft shaped so as to define at least one lateral opening,
wherein the method further comprises providing a second stent-graft, which is sized to be securely deployed partially outside and partially inside the lateral opening,
wherein releasing the endovascular implant from the proximal main delivery catheter comprises releasing the first stent-graft from the proximal main delivery catheter, and
wherein the method further comprises, (a) after releasing the first stent-graft from the proximal main delivery catheter, and (c) before transitioning the distal restraining assembly to the disengaged state:
fixing the distal end of the restraining-assembly tubular shaft stationary outside the second vascular access site, such that the distal restraining assembly prevents proximal displacement of the first stent-graft relative to the distal restraining assembly; and
introducing the second stent-graft into the vasculature in a radially compressed state, advancing the second stent-graft partially through the lateral opening of the first stent-graft, and deploying the second stent-graft partially in the vasculature external to the lateral opening and partially inside the first stent-graft.
Inventive concept 23. The method according to inventive concept 1,
wherein endovascularly introducing and advancing the delivery tool comprise:
wherein introducing and advancing the second stent-graft comprises introducing a second guidewire into the vasculature through the first vascular access site, and introducing and advancing the second stent-graft over the second guidewire, while the first guidewire remains in the vasculature.
Inventive concept 24. The method according to inventive concept 1, wherein introducing the delivery tool into the vasculature comprises introducing the delivery tool into an artery.
Inventive concept 25. The method according to inventive concept 24, wherein the artery is aneurysmatic.
Inventive concept 26. The method according to inventive concept 24, wherein a wall of the artery suffers from a dissection.
There is also provided, in accordance with an inventive concept 27 of the present invention, a method comprising:
providing (a) an elongated delivery tool having proximal and distal ends, and (b) an endovascular implant, which is removably connected to the distal end of the delivery tool, such that proximal movement of the implant toward the first proximal of the delivery tool is substantially prevented;
while the endovascular implant is disposed in a radially-compressed delivery state within the delivery tool, endovascularly introducing the delivery tool into vasculature of a patient, such that (a) a proximal longitudinal portion of the delivery tool, which includes the proximal end, passes through a first vascular access site, (b) a distal longitudinal portion of the delivery tool, which includes the distal end, passes through a second vascular access site, and (c) an intermediate longitudinal portion of the delivery tool is disposed between the first and the second vascular access sites within the vasculature,
securing the distal end of the delivery tool from being substantially withdrawn into the second vascular access site;
releasing the endovascular implant from the delivery tool, such that the endovascular implant transitions to a radially-expanded deployment state in the vasculature;
removing a portion of the delivery tool from the vasculature by pulling the proximal end of delivery tool out of the first vascular access site;
effecting detachment of the distal end of the delivery tool from the implant; and
thereafter, extracting a remainder of the delivery tool from the vasculature by pulling the distal end of the delivery tool out of the second vascular access site.
Inventive concept 28. The method according to inventive concept 27, wherein releasing comprises releasing the implant from the delivery tool by longitudinally translating a component of the delivery tool toward the proximal end of the delivery tool.
Inventive concept 29. The method according to inventive concept 27, wherein endovascularly introducing comprises endovascularly introducing the delivery tool such that the implant generally spans a lesion within the blood vessel.
Inventive concept 30. The method according to inventive concept 27, wherein endovascularly introducing and advancing the delivery tool comprise:
endovascularly introducing a guidewire of the delivery tool through one of the first and the second vascular access sites into the vasculature;
advancing the guidewire through the vasculature to the other of the first and the second vascular access sites;
extracting a portion of the guidewire from the vasculature and the body of the patient through the other of the first and the second vascular access sites, such that the guidewire extends between the first and the second vascular access sites through the vasculature; and
endovascularly introducing the delivery tool over the guidewire until the distal end of the delivery tool exits the vasculature and the body of the patient through the second vascular access site.
Inventive concept 31. The method according to inventive concept 27, wherein providing the endovascular implant comprises providing a stent-graft, which comprises a flexible stent member, and a generally tubular fluid flow guide, which is securely attached to and covers at least a portion of the stent member.
Inventive concept 32. The method according to inventive concept 31,
wherein the stent-graft is a first stent-graft shaped so as to define at least one lateral opening,
wherein the method further comprises providing a second stent-graft, which is sized to pass at least partially through the lateral opening,
wherein releasing the endovascular implant from the delivery tool comprises releasing the first stent-graft from the delivery tool, and
wherein the method further comprises, (a) after releasing the first stent-graft from the delivery tool, and (c) before effecting the detachment of the distal end of the delivery tool from the first stent-graft:
fixing the distal end of the delivery tool stationary outside the second vascular access site, such that the delivery tool prevents proximal displacement of the first stent-graft relative to the distal restraining assembly; and
introducing the second stent-graft into the vasculature, advancing the second stent-graft through the lateral opening of the first stent-graft, and deploying the second stent-graft in the vasculature.
Inventive concept 33. The method according to inventive concept 32,
wherein endovascularly introducing the delivery tool comprises:
wherein introducing and advancing the second stent-graft comprises introducing a second guidewire into the vasculature through the first vascular access site, and introducing and advancing the second stent-graft over the second guidewire, while the first guidewire remains in the vasculature.
There is further provided, in accordance with an inventive concept 34 of the present invention, a method comprising:
providing an endovascular stent-graft, which includes (a) a flexible stent member, and (b) a tubular fluid flow guide, which includes (i) a first fabric, which comprises a first biologically-compatible substantially blood-impervious material, and which is attached to and covers the stent member along a first longitudinal portion of the stent-graft, and (ii) a second fabric, which comprises a second biologically-compatible substantially blood-impervious material different from the first material, and which is attached to and covers the stent member along a second longitudinal portion of the stent-graft, which second longitudinal portion is at least partially non-longitudinally-overlapping with the first longitudinal portion; and
implanting the stent-graft in vasculature of a patient.
Inventive concept 35. The method according to inventive concept 34, wherein providing the stent-graft comprises providing the stent-graft in which the first material is less thrombogenic than the second material.
Inventive concept 36. The method according to inventive concept 35, wherein providing the stent-graft comprises providing the stent-graft in which the second material is stronger than the first material.
Inventive concept 37. The method according to any one of inventive concepts 35 and 36,
wherein implanting the stent-graft comprises endovascularly introducing the stent-graft into the vasculature while the stent-graft is in radially-compressed delivery state, and transitioning the stent-graft to a radially-expanded deployment state in the vasculature, and
wherein providing the stent-graft comprises providing the stent-graft in which a perimeter of the stent-graft at a first end thereof is less than a perimeter of the stent-graft at a second end thereof, when the stent-graft is in the radially-expanded deployment state, and the first longitudinal portion extends to the first end of the stent-graft.
Inventive concept 38. The method according to inventive concept 34, wherein implanting the stent-graft comprises positioning the stent-graft such that the second longitudinal portion is at least partially positioned in a main body lumen, and the first longitudinal portion is at least partially positioned in a branching body lumen that branched from the main body lumen.
Inventive concept 39. The method according to any one of inventive concepts 35 and 36,
wherein the method further comprises providing a main stent-graft, which is shaped so as to define a lateral opening, and
wherein providing the stent-graft comprises providing a branching stent graft, in which the second longitudinal portion is shaped so as to define an interface portion configured to form a blood-tight seal with the lateral opening of the main stent-graft.
Inventive concept 40. The method according to inventive concept 35, wherein providing the stent-graft comprises providing the stent-graft in which the first material comprises expanded polytetrafluoroethylene (ePTFE).
Inventive concept 41. The method according to any one of inventive concepts 34, 35, 36, and 40, wherein providing the stent-graft comprises providing the stent-graft in which the second material comprises a polyester.
Inventive concept 42. The method according to inventive concept 34, wherein providing the stent-graft comprises providing the stent-graft in which the first and the second longitudinal portions are non-longitudinally-overlapping.
Inventive concept 43. The method according to inventive concept 42, wherein providing the stent-graft comprises providing the stent-graft in which the first and the second longitudinal portions are longitudinally adjacent each other.
Inventive concept 44. The method according to inventive concept 43, wherein providing the stent-graft comprises providing the stent-graft in which the first and the second fabrics are coupled to each other at a longitudinal junction between the first and the second longitudinal portions.
Inventive concept 45. The method according to inventive concept 34, wherein providing the stent-graft comprises providing the stent-graft in which the first and the second longitudinal portions are partially longitudinally overlapping along an longitudinally overlapping portion of the stent-graft.
Inventive concept 46. The method according to inventive concept 45, wherein providing the stent-graft comprises providing the stent-graft in which the first and the second fabrics are coupled to each other at one or more locations along the longitudinally overlapping portion.
The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:
Stent member 32 is typically flexible, and comprises a plurality of structural stent elements 38 (i.e., struts), which optionally are axially separate from one another, such as shown in
Fluid flow guide 34, if provided, comprises at least one piece of biologically-compatible substantially blood-impervious fabric. The fabric may comprise, for example, a polyester, a polyethylene (e.g., a poly-ethylene-terephthalate), a polymeric film material (e.g., polytetrafluoroethylene), a polymeric textile material (e.g., woven polyethylene terephthalate (PET)), natural tissue graft (e.g., saphenous vein or collagen), or a combination thereof.
Delivery tool 30 comprises proximal main delivery catheter 36, which has a distal portion 46 in which implant 20 is disposed while in the radially-compressed delivery state, as shown in
When in the engaged state, distal restraining assembly 50 is configured to prevent distal migration of implant 20 during the implantation procedure.
Typically, restraining-assembly tubular shaft 52 has a length of between 10 and 80 CM.
For some applications, distal restraining assembly 50 comprises one or more release effector flexible elongated members 56, such as sutures, wires, or strings. Flexible elongated members 56 extend from a proximal end 58 of restraining-assembly tubular shaft 52. When distal restraining assembly 50 is in the engaged state, flexible elongated members 56 releasably couple distal restraining assembly 50 and/or restraining-assembly tubular shaft 52 to a distal portion 60 of implant 20, such as a distal portion of stent member 32 (for example, a portion of the stent member that extends distally beyond a distal end of tubular fluid flow guide 34, if provided, such as shown in
For some applications, when implant 20 is disposed within delivery tool 30 (typically in the proximal main delivery catheter) in the radially-compressed delivery state, a first longitudinal portion of delivery tool 30 extends between a proximal end of the implant and a first (proximal) end of the delivery tool, and a second longitudinal portion of delivery tool 30 extends between a distal end of the implant and second (distal) end of the delivery tool. The first and the second longitudinal portions have respective lengths, each of which is at least 10 cm, such as at least 20 cm. For some applications, a total length of the delivery tool is at least 60 cm.
Typically, delivery tool 30 further comprises a tip 70 disposed longitudinally between proximal main delivery catheter 36 and restraining-assembly tubular shaft 52, at least prior to deployment of implant 20 from proximal main delivery catheter 36. When implant 20 is in the radially-expanded deployment state and distal restraining assembly 50 is in the engaged state, such as shown in
For some applications, proximal main delivery catheter 36 comprises inner and outer tubular shafts 74 and 76. The shafts are longitudinally translatable with respect to each other, and implant 20 is disposed radially between inner and outer shafts 74 and 76 while in the radially-compressed delivery state, such as shown in
For some applications, tip 70 is fixed to a distal end of inner shaft 74. For some applications, tip 70 gradually tapers from (a) a proximal-end diameter DP at a proximal end 78 thereof equal to between 90% and 110% of an outer diameter DT of a distal end 79 of outer tubular shaft 76 to (b) a distal-end diameter DD at distal end 73 thereof equal to between 70% and 100% of an outer diameter DS of proximal end 58 of restraining-assembly tubular shaft 52.
Typically, endovascular system 10 further comprises a guidewire 80. Delivery tool 30 is configured to receive the guidewire therethrough, such that the delivery tool radially surrounds the guidewire. The delivery tool is advanceable over the guidewire. Typically, the delivery tool is configured to receive the guidewire therethrough such that the guidewire extends from a proximal end of proximal main delivery catheter 36 to a distal end 111 of restraining-assembly tubular shaft 52, at least when distal restraining assembly 50 is in the engaged state, as described in more detail hereinbelow with reference to
Typically, proximal main delivery catheter 36 and restraining-assembly tubular shaft 52 are shaped so as to define respective guidewire longitudinal lumens 82 and 112 therethrough. For some applications, inner shaft 74 of proximal main delivery catheter 36 is shaped so as to define guidewire longitudinal lumen 82. For some applications, tip 70 is shaped so as to define a tip guidewire longitudinal lumen 84.
Reference is now made to
For some applications, the restraining-assembly tubular shaft 52 is shaped so as to define one or more longitudinal elongated-member lumens 110 therethrough, through which flexible elongated members 56 are slidably disposed at least when distal restraining assembly 50 is in the engaged state. Flexible elongated members 56 exit lumens 110 at distal end 111 of restraining-assembly tubular shaft 52. For some applications, flexible elongated members 56 are looped through respective sites of distal portion 60 of implant 20, and looped at distal portions of the members that extend distally out of lumens 110. Each member may be doubled, such that a first portion of the member is in one of lumens 110 and a second portion of the member is another of lumens 110. Cutting the loops of the distal portions of the members that extend out of lumens 110 frees the members from implant 20, such as described hereinbelow with reference to
As described above, restraining-assembly tubular shaft 52 is typically shaped so as to further define longitudinal guidewire lumen 112 therethrough, through which guidewire 80 is removably disposed. Guidewire 80 exits lumen 112 at distal end 111 of restraining-assembly tubular shaft 52. For some applications, guidewire lumen 112 is disposed along a central longitudinal axis of restraining-assembly tubular shaft 52.
Reference is now made to
For some applications, the stopper member is positioned adjacent a distal end of implant 20 while the implant is in the radially-compressed delivery state, disposed radially between inner and outer shafts 74 and 76, as shown in
For some applications, stopper member 120 is implemented in a delivery tool that does not comprise distal restraining assembly 50.
Reference is made to
In this configuration, flexible elongated members 56 are releasably coupled to a distal portion of tubular fluid flow guide 34. Optionally, the fluid flow guide comprises one or more eyelets, through which the elongated members pass, in order to reduce the risk of tearing the graft material of the fluid flow guide.
Reference is made to
In this configuration, flexible longitudinal members 56 are configured to transition distal restraining assembly 50 from the engaged state to the disengaged state by rotation of each of the flexible longitudinal members around a longitudinal axis thereof. For example, flexible longitudinal members 56 may be shaped so as to define proximal hooks 130. The hooks may be stiff enough to engage stent elements 38 when distal restraining assembly 50 is in the engaged state, as shown in
Reference is made to
As shown in
As shown in
Respective first portions of flexible elongated members 56 of distal restraining assembly 50 extend out of distal end 111 of restraining-assembly tubular shaft 52, and thus pass through the second vascular access site together with (within) restraining-assembly tubular shaft 52, and thus are accessible from outside the patient's body. In addition, flexible elongated members 56 are positioned such that they pass through restraining-assembly tubular shaft 52 (and are typically longitudinally slidable therewithin), pass over external surface 72 of tip 70, and are releasably coupled to the distal portion of implant 20. Flexible elongated members 56 thus are configured to be effected, from a site distal to distal end 111 restraining-assembly tubular shaft 52, to effect the disengagement (i.e., release) of implant 20 from distal restraining assembly 50 at the proximal ends of the flexible elongated members.
Endovascular implant 20 is disposed radially between inner and outer shafts 74 and 76, restrained by outer shaft 76 in the radially-compressed delivery state.
As shown in
As shown in
As shown in
In addition, for some applications, guidewire 80 helps hold implant 20 in place in the vasculature. The operator typically fixes and/or secures (e.g., using forceps) one end (such as the distal end) of the guidewire securely outside the vasculature, while manually making a “fixed point” on the other end. Holding the guidewire tightly in place creates a more constrained path for advancement of delivery tool 30 thereover. As the delivery tool tracks over the guidewire, the delivery tool tracks a more predictable and stable trajectory inside the vasculature than if the guidewire were not secured at both ends thereof. As a result, inadvertent interaction between the delivery tool and the blood vessel wall is reduced, thereby reducing debris release and the risk of stroke. In addition, holding the guidewire tightly in place may also press one aspect of the implant against the wall of the blood vessel. This technique also helps hold the implant in place during a subsequent step of the implantation procedure, such as the advancement of one or more second implants 200, such as described hereinbelow with reference to
These stabilization techniques allow a significantly increased level of migration resistance for the already deployed implant(s) of endovascular system 10, especially when bulky and/or stiff delivery systems containing additional branching endovascular implants of system 10 are subsequently inserted via side-facing fenestrations of a previously deployed endovascular implant, and during such deployment may exert significant longitudinal forces on the already-deployed endovascular implants.
As shown in
If necessary, the operator may pull the distal end of restraining-assembly tubular shaft 52 distally from outside second vascular access site 215B, thereby distally displacing endovascular implant 20. For example, such repositioning may be desired if the implant was inadvertently deployed too proximally, or if the implant slid proximally after deployment, such as during deployment of additional endovascular implants, as described immediately hereinbelow. Alternatively or additionally, if necessary the operator may rotate distal restraining assembly 50 (e.g., restraining-assembly tubular shaft 52 thereof) from outside the second vascular access site, thereby rotating endovascular implant 20. For example, such rotation may be desired the implant was inadvertently deployed with improper rotational alignment. (As mentioned above, flexible elongated members 56 may comprise wires; these wires may be configured to apply a rotational force to the implant.)
As shown in
As shown in
As shown in
As shown in
As shown in
The one or more second implants 200 are coupled to first implant 20, in order to provide one or more continuous blood-flow lumens through aneurysmatic abdominal aorta 210 to iliac arteries 214A and 214B. The implants are coupled together to form substantially blood impervious seals. As a result, blood flows through the one or more second implants 200 into first implant 20 and feeds both iliac arteries.
Also as shown in
For some applications, in order to disengage distal restraining assembly 50, distal portions of flexible elongated members 56 that extend beyond distal end 111 of restraining-assembly tubular shaft 52 are cut, as shown in blow-up A of
Reference is made to
In the particular configuration described with reference to
a proximal superior first lateral opening 334A;
a distal superior first lateral opening 334B; and
a distal inferior first lateral opening 334C.
Typically, when stent-graft 320 is unconstrained in its radially-expanded state, proximal and distal superior first lateral openings 334A and 334B face in a first radial direction, and distal inferior first lateral opening 334C faces in a second radially direction generally circumferentially opposite the first radial direction. For example, if the stent-graft is viewed from one end, proximal and distal superior first lateral openings 334A and 334B may be disposed at between 11 o'clock and 1 o'clock (e.g., at 12 o'clock), and distal inferior first lateral opening 334C may be disposed at between 5 o'clock and 7 o'clock (e.g., at 6 o'clock).
As shown in
As shown in
As shown in
As shown in
As shown in
In addition, for some applications, guidewire 80 helps hold stent-graft 320 in place. The operator typically fixes and/or secures (e.g., using forceps) one end (such as the distal end) of the guidewire securely outside the vasculature, while manually making a “fixed point” on the other end. Holding the guidewire tightly in place creates a more constrained path for advancement of delivery tool 30 thereover. As the delivery tool tracks over the guidewire, the delivery tool tracks a more predictable and stable trajectory inside the vasculature than if the guidewire were not secured at both ends thereof. As a result, inadvertent interaction between the delivery tool and the blood vessel wall is reduced, thereby reducing debris release and the risk of stroke. In addition, holding the guidewire tightly in place may also press one aspect of the implant against the wall of the blood vessel. This technique also helps hold the implant in place during a subsequent step of the implantation procedure, such as the advancement of one or more second endovascular stent-grafts 322, such as described hereinbelow with reference to
These stabilization techniques allow a significantly increased level of migration resistance for the already deployed implant(s) of endovascular system 10, especially when bulky and/or stiff delivery systems containing additional branching endovascular implants of system 10 are subsequently inserted via side-facing fenestrations of a previously deployed endovascular implant, and during such deployment may exert significant longitudinal forces on the already-deployed endovascular implants.
As shown in
Distal restraining assembly 50 remains in the engaged state at this stage of the implantation procedure, preventing proximal movement of stent-graft 320. Guidewire 80 may also prevent movement of stent-graft 320, as described above with reference to
If necessary, the operator may pull the distal end of restraining-assembly tubular shaft 52 distally from outside second vascular access site 315B, thereby distally displacing stent-graft 320. For example, such repositioning may be desired if the stent-graft was inadvertently deployed too proximally, or if the stent-graft slid proximally after deployment, such as during deployment of additional stent-grafts, as described immediately hereinbelow. Alternatively or additionally, if necessary the operator may rotate distal restraining assembly 50 (e.g., restraining-assembly tubular shaft 52 thereof) from outside the second vascular access site, thereby rotating stent-graft 320. For example, such rotation may be desired the implant was inadvertently deployed with improper rotational alignment. (As mentioned above, flexible elongated members 56 may comprise wires; these wires may be configured to apply a rotational force to the stent-graft.)
As can be seen in
Also as shown in
Reference is still made to
For some applications, endovascular stent-graft 320 comprises two different fabrics. Fluid flow guide 326 of endovascular stent-graft 320 comprises first and second fabrics 356 and 358, which are attached to and cover stent member 324 along first and second longitudinal portions 350 and 352 of stent-graft 320. First and second longitudinal portions 350 and 352 are at least partially non-longitudinally-overlapping.
First and second fabrics 356 and 358 comprise first and second biologically-compatible substantially blood-impervious materials, respectively, which are different from each other. Typically, the first material is less thrombogenic than the second material, and may comprise, for example, ePTFE. As used in the present application, including in the claims, “thrombogenic” means the tendency of a material in contact with the blood to produce a thrombus or embolus. Typically, the second material less deformable than the first material, and may comprise, for example, polyester, such as a biostable polymer, e.g., PET.
Typically, first longitudinal portion 350 is located along a narrower portion of the stent-graft that is configured to be positioned in a smaller blood vessel, such as one of the branches of the aortic arch feeding the cranial circulation. For some applications, a perimeter of stent-graft 320 at first end thereof is less than a perimeter of stent-graft 320 at a second end thereof, when the stent-graft is in the radially-expanded deployment state, and first longitudinal portion 350 extends to the first end of the stent-graft.
For some applications, as shown in
For other applications, as shown in
Reference is still made to
For some applications, as described with reference to
These techniques described with reference to
Reference is now made to
For some applications, a length of a first one of the branching lumens is less than 90% of a length of a second one of the branching lumens. For some applications, the length of the first one of the branching lumens is at least 10% greater than the length of the second one of the branching lumens.
The scope of the present invention includes embodiments described in the following applications, which are assigned to the assignee of the present application and are incorporated herein by reference. In an embodiment, techniques and apparatus described in one or more of the following applications are combined with techniques and apparatus described herein:
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
This present application is the U.S. national stage of International Application PCT/IL2014/050019, filed Jan. 7, 2014, which claims priority from U.S. Provisional Application 61/749,965, filed Jan. 8, 2013, which is assigned to the assignee of the present application and is incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IL2014/050019 | 1/7/2014 | WO | 00 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2014/108895 | 7/17/2014 | WO | A |
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