Minimization of stent-graft migration during implantation

• US 9,993,360 B2
• Filed: 01/07/2014
• Issued: 06/12/2018
• Est. Priority Date: 01/08/2013
• Status: Active Grant

• Current Assignee: Endospan Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Shalev, Alon, Marmur, Yaniv, Nissan, Ori, Nae, Nir Shalom
• Primary Examiner(s): Shi, Katherine M
• Application Number:
  US14/759,736
• Publication Number:
  US 20150351943A1
• Time in Patent Office: 1,617 Days
• Field of Search: 623 111, 623 112
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

An endovascular system (10) includes an endovascular implant (20) and a delivery tool (30). The implant (20) is configured to assume a radially-compressed delivery state, and a radially-expanded deployment state. The delivery tool (30) includes a proximal main delivery catheter (36), having a distal portion (46) in which the implant (20) is disposed while in the radially-compressed delivery state; and a distal restraining assembly (50), which includes a restraining-assembly tubular shaft (52) disposed distal to the proximal main delivery catheter (36). The distal restraining assembly (50) is configured to assume an engaged state, in which the distal restraining assembly (50) prevents proximal displacement of the implant (20) relative to the distal restraining assembly (50), and a disengaged state, in which the distal restraining assembly (50) allows proximal displacement of the implant (20) relative to the distal restraining assembly (50). Other embodiments are also described.

Claims

1. Apparatus comprising an endovascular system, which comprises:

an endovascular implant, which is configured to assume a radially-compressed delivery state, and a radially-expanded deployment state; and

a delivery tool, which comprises;

a proximal main delivery catheter, having a distal portion in which the endovascular implant is disposed while in the radially-compressed delivery state; and

a distal restraining assembly, which (a) comprises (i) a restraining-assembly tubular shaft, wherein a proximal end of the restraining-assembly tubular shaft is disposed distal to the proximal main delivery catheter, and wherein the restraining-assembly tubular shaft is shaped so as to define one or more longitudinal elongated-member lumens therethrough, and (ii) one or more flexible elongated members, which extend from the proximal end of the restraining-assembly tubular shaft, and (b) is configured to assume;

an engaged state, in which (a) the distal restraining assembly prevents proximal displacement of the endovascular implant relative to the distal restraining assembly, and (b) the one or more flexible elongated members are slidably disposed through the one or more longitudinal elongated-member lumens and releasably couple an element of the endovascular system to a distal portion of the endovascular implant, the element selected from the group consisting of;

the distal restraining assembly and the restraining-assembly tubular shaft, and

a disengaged state, in which the distal restraining assembly allows proximal displacement of the endovascular implant relative to the distal restraining assembly.

2. The apparatus according to claim 1, wherein the endovascular implant comprises a stent member, and wherein 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.

3. The apparatus according to claim 1,

wherein the delivery tool further comprises a tip disposed longitudinally between the proximal main delivery catheter and the restraining-assembly tubular shaft, and

wherein, when the endovascular 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 endovascular implant without entangling the tip with the flexible elongated members.

4. The apparatus according to claim 3, wherein the flexible elongated members pass over an external surface of the tip when the distal restraining assembly is in the engaged state.

5. The apparatus according to claim 4, wherein the external surface of the tip is shaped so as to define one or more grooves, and wherein the flexible elongated members are disposed within the grooves while the flexible elongated members pass over the external surface.

6. The apparatus according to claim 1, wherein the endovascular system further comprises a guidewire, and wherein the restraining-assembly tubular shaft is shaped so as to further define a longitudinal guidewire lumen therethrough, through which the guidewire is removably disposed.

7. The apparatus according to claim 6, wherein the guidewire lumen is disposed along a central longitudinal axis of the restraining-assembly tubular shaft.

8. The apparatus according to claim 6, wherein, in cross-section perpendicular to a longitudinal axis of the restraining-assembly tubular shaft, the longitudinal guidewire lumen is larger than each of the one or more longitudinal elongated-member lumens.

9. The apparatus according to claim 1, wherein, 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 extends between a proximal end of the endovascular implant and a proximal end of the delivery tool, a second longitudinal portion of the delivery tool extends between a distal end of the endovascular implant and a distal end of the delivery tool, and the first and the second longitudinal portions have respective lengths, each of which is at least 20 cm.

10. The apparatus according to claim 1, wherein the distal restraining assembly is 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.

11. The apparatus according to claim 1, wherein the delivery tool further comprises a tip disposed longitudinally between the proximal main delivery catheter and the restraining-assembly tubular shaft while the endovascular implant is disposed in the proximal main delivery catheter and the distal restraining assembly is in the engaged state.

12. The apparatus according to claim 11, wherein the proximal main delivery catheter comprises inner and outer tubular shafts, and wherein the tip is fixed to a distal end of the inner shaft.

13. The apparatus according to claim 11, wherein the tip is conically shaped.

14. The apparatus according to claim 11, wherein the proximal main delivery catheter comprises inner and outer tubular shafts, and wherein 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.

15. The apparatus according to claim 1, wherein the endovascular implant comprises 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.

16. The apparatus according to claim 15, wherein the one or more flexible elongated members securely engage the fluid flow guide when the distal restraining assembly is in the engaged state.

17. The apparatus according to claim 15,

wherein the stent-graft is a first stent-graft, which is shaped so as to define at least one lateral opening, and

wherein the endovascular system further comprises a second stent-graft, which is sized to pass at least partially through the lateral opening.

18. The apparatus according to claim 1, wherein the one or more flexible elongated members are disengaged from the endovascular implant when the distal restraining assembly is in the disengaged state.

19. The apparatus according to claim 1, wherein the one or more 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 one or more flexible longitudinal members around a longitudinal axis thereof.

20. The apparatus according to claim 1, wherein the restraining-assembly tubular shaft has a length of at least 10 cm.

21. The apparatus according to claim 1, wherein the restraining-assembly tubular shaft has a length of between 10 and 80 cm.

22. The apparatus according to claim 1, wherein the one or more flexible elongated members exit the one or more longitudinal elongated-member lumens at a distal end of the restraining-assembly tubular shaft at least when the distal restraining assembly is in the engaged state.

23. The apparatus according to claim 1, for use with a guidewire, wherein the restraining-assembly tubular shaft is shaped so as to further define a longitudinal guidewire lumen therethrough, through which the guidewire is removably disposed.

24. The apparatus according to claim 1, wherein the proximal main delivery catheter and the restraining-assembly tubular shaft are shaped so as to define respective guidewire longitudinal lumens therethrough.

25. A method comprising:

providing (a) an endovascular implant and (b) a delivery tool which includes (i) a proximal main delivery catheter and (ii) a distal restraining assembly, which includes (A) a restraining-assembly tubular shaft, wherein a proximal end of the restraining-assembly tubular shaft is disposed distal to the proximal main delivery catheter, and wherein the restraining-assembly tubular shaft is shaped so as to define one or more longitudinal elongated-member lumens therethrough, and (B) one or more flexible elongated members, which extend from the proximal end of the restraining-assembly tubular shaft;

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 (a) the distal restraining assembly prevents proximal displacement of the endovascular implant relative to the distal restraining assembly, and (b) the one or more flexible elongated members are slidably disposed through the one or more longitudinal elongated-member lumens and releasably couple an element of the endovascular system to a distal portion of the endovascular implant, the element selected from the group consisting of;

the distal restraining assembly and the restraining-assembly tubular shaft;

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, including 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 the body of the patient;

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 endovascular implant and allows proximal displacement of the endovascular implant relative to the distal restraining assembly; and

thereafter, extracting the distal restraining assembly from the vasculature and the body of the patient through the second vascular access site.

26. The method according to claim 25, 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.

27. The method according to claim 26,

wherein the restraining-assembly tubular shaft is shaped so as to further define 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.

28. The method according to claim 25, 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 endovascular implant relative to the distal restraining assembly.

29. The method according to claim 25, 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.

30. The method according to claim 25,

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.

31. The method according to claim 30, wherein releasing the endovascular implant from the proximal main delivery catheter further comprises, after the endovascular implant transitions to the radially-expanded deployment state, proximally withdrawing the tip into the endovascular implant without entangling the tip with the flexible elongated members.

32. The method according to claim 30, 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.

33. The method according to claim 32, 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.