Method of delivering advanced endovascular graft and system

• US 8,864,814 B2
• Filed: 09/27/2011
• Issued: 10/21/2014
• Est. Priority Date: 12/20/2001
• Status: Expired due to Fees

• Current Assignee: Endologix
• Original Assignee: Trivascular Incorporated
• Inventors: Chobotov, Michael V.
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US13/246,651
• Publication Number:
  US 20120022636A1
• Time in Patent Office: 1,120 Days
• Field of Search: 623/1.11, 623 113- 116, 623/1.23, 623 135- 136, 606/108
• US Class Current: 623/1.14
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes

Abstract

A flexible low profile delivery system for delivery of an expandable intracorporeal device, specifically, an endovascular graft, which has at least one belt circumferentially disposed about the device in a constraining configuration. The belt is released by a release member, such as a release wire, by retracting the wire from looped ends of the belt. Multiple belts can be used and can be released sequentially so as to control the order of release and placement of the endovascular graft. An outer protective sheath may be disposed about the endovascular graft while in a constrained state which must first be refracted or otherwise removed prior to release of the graft from a constrained state. The delivery system can be configured for delivery over a guiding device such as a guidewire. The delivery system can also be configured for delivery of bifurcated intracorporeal devices.

Claims

1. An endovascular graft delivery system configured to deliver an endovascular graft to a target location within a patient'"'"'s vasculature and deploy the endovascular graft at the target location, comprising:

an endovascular graft comprising;

a proximal end, a distal end, a tubular graft body section disposed between the proximal end and the distal end; and

a first distal self-expanding member that is disposed distally of;

(i) a second self-expanding member and (ii) the distal end of the graft body section;

wherein the first distal self-expanding member comprises;

a proximal end, a distal end, a plurality of struts and a plurality of apices at each of the proximal and distal ends;

a barb integrally formed as a part of at least one strut without a joint and without other mechanical connection thereat and extending outwardly from a position on said at least one strut, wherein said at least one strut comprises an outer surface and an opposed inner surface, thereby defining a strut wall therein between; and

at least one slot formed as an opening directly through only one longitudinal portion of said one of at least one of the struts from said outer surface of said at least one strut to said opposed inner surface of said at least one strut, said opening being bounded only by the one longitudinal portion of said strut wall of said at least one strut, said at least one strut containing said portion being disposed between one of said plurality of apices at said proximal end and one of said plurality of apices at said distal end, wherein at least one of the proximal and distal apices are curved apices; and

a delivery system comprising;

an elongate shaft having a proximal section and a distal section;

an outer tubular member with the graft body section being disposed within the outer tubular member in a radially constrained state;

a constraint disposed at the first distal self-expanding member; and

a release member for releasing the constraint;

wherein the outer tubular member is configured to be retracted proximally to expose the graft body section; and

wherein the release member is operable to release the constraint from the first distal self-expanding member after the outer tubular member is retracted proximally to at least partially expose the graft body section.

2. The endovascular graft delivery system of claim 1, further comprising a handle for manipulation to move the release member to release the constraint disposed at the first distal self-expanding member.

3. The endovascular graft delivery system of claim 1, wherein the endovascular graft delivery system has a delivery profile from about 10 French to about 16 French.

4. The endovascular graft delivery system of claim 1, wherein the endovascular graft delivery system has a delivery profile of about 16 French.

5. The endovascular graft delivery system of claim 1, wherein the at least one slot is configured to the shape of the at least one barb.

6. The endovascular graft delivery system of claim 1, wherein the self-expanding members comprises NiTi.

7. The endovascular graft delivery system of claim 1, wherein the first distal self-expanding member is a two-stage stent having interconnected intermediate stent portions.

8. The endovascular graft delivery system of claim 1, wherein the at least one barb is oriented in a proximal direction and has an elevation angle with respect to a longitudinal axis of a strut from which the barb extends of about 10 degrees to about 45 degrees.

9. The endovascular graft delivery system of claim 1, wherein the at least one barb is proximal to an apex.

10. The endovascular graft delivery system of claim 1, wherein some of said struts and some of said apices are free of barbs.

11. The endovascular graft delivery system of claim 1, wherein some of said apices are free of barbs.

12. The endovascular graft delivery system of claim 1, wherein the elongate shaft of the delivery system further comprises a guidewire lumen.

13. The endovascular graft delivery system of claim 1, wherein the at least one barb is configured to engage tissue of the patient'"'"'s vasculature to prevent migration of the endovascular graft within the patient'"'"'s vasculature.

14. The endovascular graft delivery system of claim 1, wherein the endovascular graft is bifurcated such that the tubular graft body section further comprises a main body portion and a bifurcation from which extend in a proximal direction (i) an ipsilateral leg terminating proximally with a first proximal self-expanding member and (ii) a contralateral leg terminating proximally with a second proximal self-expanding member.

15. The endovascular graft delivery system of claim 1, further comprising a radiopaque marker secured thereto.

16. The endovascular graft delivery system of claim 1, further comprising a radiopaque marker secured to the endovascular graft.

17. The endovascular graft delivery system of claim 14, wherein the first and second proximal self-expanding members comprise NiTi.

18. The stent of claim 1, wherein the proximal and distal apices are curved apices.

19. The stent of claim 1, wherein the graft body section comprises polyester.

20. A method of treating a patient'"'"'s vasculature by using the endovascular graft delivery system of claim 1, comprising:

providing the endovascular graft delivery system of claim 1;

delivering the endovascular graft in the radially constrained state to a target location within a patient'"'"'s body passageway with the delivery system;

moving the outer tubular member proximally relative to the endovascular graft;

deploying the second distal self-expanding member of the endovascular graft, whereby the second distal self-expanding member self-expands while the first distal self-expanding member remains in at least partially the radially constrained state; and

deploying the first distal self-expanding member by releasing the constraint such that the first distal self-expanding member engages tissue of the patient'"'"'s body passageway in which the endovascular graft is at least partially deployed and prevents axial migration of the endovascular graft.

21. An endovascular graft delivery system configured to deliver an endovascular graft to a target location within a patient'"'"'s vasculature and deploy the endovascular graft at the target location, comprising:

an endovascular graft comprising;

a proximal end, a distal end, a tubular graft body section disposed between the proximal end and the distal end; and

a first distal self-expanding member that is disposed distally of;

(i) a second self-expanding member and (ii) the distal end of the graft body section;

wherein the first distal self-expanding member comprises;

a proximal end, a distal end and a plurality of struts and joined by curved apices at the proximal and distal ends of said stent;

at least one barb on at least one strut, the barb being an extension of the strut in which no joint and no other connection to the strut exists, wherein said at least one strut comprises an outer surface and an opposed inner surface, thereby defining a strut wall therein between; and

at least one slot formed as an opening directly through only one longitudinal portion of said one of at least one of the struts from said outer surface of said at least one strut to said opposed inner surface of said at least one strut, said opening being bounded only by the one longitudinal portion of said strut wall of said at least one strut, said at least one strut containing said portion being disposed between one of said plurality of apices at said proximal end and one of said plurality of apices at said distal end, the slot being configured to the shape of the at least one barb, wherein the first distal self-expanding member is a two-stage stent having interconnected intermediate stent portions, and wherein said curved apices have an outer lateral surface with a radius of curvature; and

a delivery system comprising;

an elongate shaft having a proximal section and a distal section;

an outer tubular member with the graft body section being disposed within the outer tubular member in a radially constrained state;

a constraint disposed at the first distal self-expanding member; and

a release member for releasing the constraint;

wherein the outer tubular member is configured to be retracted proximally to expose the graft body section; and

wherein the release member is operable to release the constraint from the first distal self-expanding member after the outer tubular member is retracted proximally to at least partially expose the graft body section.

22. The endovascular graft delivery system of claim 21, further comprising a handle for manipulation to move the release member to release the constraint disposed at the first distal self-expanding member.

23. The endovascular graft delivery system of claim 21, wherein the endovascular graft is bifurcated such that the tubular graft body section further comprises a main body portion and a bifurcation from which extend in a proximal direction (i) an ipsilateral leg terminating proximally with a first proximal self-expanding member and (ii) a contralateral leg terminating proximally with a second proximal self-expanding member.

24. A method of treating a patient'"'"'s vasculature by using the endovascular graft delivery system of claim 21, comprising:

providing the endovascular graft delivery system of claim 21;

delivering the endovascular graft in the radially constrained state to a target location within a patient'"'"'s body passageway with the delivery system;

moving the outer tubular member proximally relative to the endovascular graft;

deploying the second distal self-expanding member of the endovascular graft, whereby the second distal self-expanding member self-expands while the first distal self-expanding member remains in at least partially the radially constrained state; and

deploying the first distal self-expanding member by releasing the constraint such that the first distal self-expanding member engages tissue of the patient'"'"'s body passageway in which the endovascular graft is at least partially deployed and prevents axial migration of the endovascular graft.

25. An endovascular graft delivery system configured to deliver an endovascular graft to a target location within a patient'"'"'s vasculature and deploy the endovascular graft at the target location, comprising:

an endovascular graft comprising;

a proximal end, a distal end, a tubular graft body section disposed between the proximal end and the distal end; and

a first distal self-expanding member that is disposed distally of;

(i) a second self-expanding member and (ii) the distal end of the graft body section;

wherein the first distal self-expanding member comprises;

a proximal end, a distal end and a plurality of struts and apices at the proximal and distal ends of said stent;

at least one barb on a strut, the barb and strut comprising a barb/strut interface in which there is no mechanical connection to join the barb to the strut, wherein said at least one strut comprises an outer surface and an opposed inner surface, thereby defining a strut wall therein between; and

at least one slot formed as an opening directly through only one longitudinal portion of said one of at least one of said struts from said outer surface of said at least one strut to said opposed inner surface of said at least one strut, said opening being bounded only by the one longitudinal portion of said strut wall of said at least one strut, said at least one strut containing said portion being disposed between one of said plurality of apices at said proximal end and one of said plurality of apices at said distal end, the at least one slot being configured to the shape of the at least one barb, wherein said apices have an outer lateral surface with a radius of curvature; and

a delivery system comprising;

an elongate shaft having a proximal section and a distal section;

an outer tubular member with the graft body section being disposed within the outer tubular member in a radially constrained state;

a constraint disposed at the first distal self-expanding member; and

a release member for releasing the constraint;

wherein the outer tubular member is configured to be retracted proximally to expose the graft body section; and

wherein the release member is operable to release the constraint from the first distal self-expanding member after the outer tubular member is retracted proximally to at least partially expose the graft body section.

26. The endovascular graft delivery system of claim 25, further comprising a handle for manipulation to move the release member to release the constraint disposed at the first distal self-expanding member.

27. The endovascular graft delivery system of claim 25, wherein the endovascular graft is bifurcated such that the tubular graft body section further comprises a main body portion and a bifurcation from which extend in a proximal direction (i) an ipsilateral leg terminating proximally with a first proximal self-expanding member and (ii) a contralateral leg terminating proximally with a second proximal self-expanding member.

28. A method of treating a patient'"'"'s vasculature by using the endovascular graft delivery system of claim 25, comprising:

providing the endovascular graft delivery system of claim 25;

delivering the endovascular graft in the radially constrained state to a target location within a patient'"'"'s body passageway with the delivery system;

moving the outer tubular member proximally relative to the endovascular graft;

deploying the second distal self-expanding member of the endovascular graft, whereby the second distal self-expanding member self-expands while the first distal self-expanding member remains in at least partially the radially constrained state; and

deploying the first distal self-expanding member by releasing the constraint such that the first distal self-expanding member engages tissue of the patient'"'"'s body passageway in which the endovascular graft is at least partially deployed and prevents axial migration of the endovascular graft.

29. An endovascular graft delivery system configured to deliver an endovascular graft to a target location within a patient'"'"'s vasculature and deploy the endovascular graft at the target location, comprising:

an endovascular graft comprising;

a proximal end, a distal end, a tubular graft body section disposed between the proximal end and the distal end; and

a first distal self-expanding member that is disposed distally of;

(i) a second self-expanding member and (ii) the distal end of the graft body section;

wherein the first distal self-expanding member comprises;

a proximal end, a distal end and a plurality of struts joined by curved apices at the proximal and distal ends of said stent;

at least one barb on at least one strut, the barb being located on the strut between two apices, the barb being an extension of the strut in which no joint and no other connection to the strut exists, wherein said at least one strut comprises an outer surface and an opposed inner surface, thereby defining a strut wall therein between; and

at least one slot formed as an opening directly through only one longitudinal portion of said one of at least one of the struts from said outer surface of said at least one strut to said opposed inner surface of said at least one strut, said opening being bounded only by the one longitudinal portion of said strut wall of said at least one strut, said at least one strut containing said portion being disposed between one of said plurality of apices at said proximal end and one of said plurality of apices at said distal end, the slot being configured to the shape of the at least one barb, wherein the first distal self-expanding member is a two-stage stent having interconnected intermediate stent portions, and wherein said curved apices have an outer lateral surface with a radius of curvature; and

a delivery system comprising;

an elongate shaft having a proximal section and a distal section;

an outer tubular member with the graft body section being disposed within the outer tubular member in a radially constrained state;

a constraint disposed at the first distal self-expanding member; and

a release member for releasing the constraint;

wherein the outer tubular member is configured to be retracted proximally to expose the graft body section; and

wherein the release member is operable to release the constraint from the first distal self-expanding member after the outer tubular member is retracted proximally to at least partially expose the graft body section.

30. A method of treating a patient'"'"'s vasculature by using the endovascular graft delivery system of claim 29, comprising:

providing the endovascular graft delivery system of claim 29;

delivering the endovascular graft in the radially constrained state to a target location within a patient'"'"'s body passageway with the delivery system;

moving the outer tubular member proximally relative to the endovascular graft;

deploying the second distal self-expanding member of the endovascular graft, whereby the second distal self-expanding member self-expands while the first distal self-expanding member remains in at least partially the radially constrained state; and

deploying the first distal self-expanding member by releasing the constraint such that the first distal self-expanding member engages tissue of the patient'"'"'s body passageway in which the endovascular graft is at least partially deployed and prevents axial migration of the endovascular graft.