MODULAR VASCULAR GRAFT FOR LOW PROFILE PERCUTANEOUS DELIVERY

• US 20090099649A1
• Filed: 10/03/2008
• Published: 04/16/2009
• Est. Priority Date: 10/04/2007
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Trivascular Incorporated
• Inventors: Humphrey, Joseph W., Chobotov, Michael V., Whirley, Robert G.
• Granted Patent: US 10,159,557 B2
• Time in Patent Office: Days
• US Class Current: 623/1.36
• 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 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• 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 2002/8486 provided on at least one of the ends
• 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 2250/0069 Sealing means

Abstract

A hybrid modular endovascular graft wherein a main graft is sized to span at least a portion of a target vessel lesion in a large percentage of patients. Graft extensions may be secured to the main graft to extend the main graft and provide a sealing function for some applications.

Claims

1. A modular endovascular graft assembly, comprising:

a bifurcated main graft member formed from a supple graft material having a main fluid flow lumen therein, an ipsilateral leg with an ipsilateral fluid flow lumen in communication with the main fluid flow lumen, a contralateral leg with a contralateral fluid flow lumen in communication with the main fluid flow lumen and a network of inflatable channels disposed on the main graft member including the ipsilateral and contralateral legs which is configured to accept a hardenable fill material to provide structural rigidity to the main graft member when the network of inflatable channels are in an inflated state and which includes at least one inflatable cuff disposed on a proximal portion of the main graft member configured to seal against an inside surface of a patient'"'"'s vessel;

a proximal anchor member disposed at a proximal end of the main graft member and secured to the main graft member and having a self-expanding proximal stent portion secured to a self-expanding distal stent portion with struts having a cross sectional area that is substantially the same as or greater than a cross sectional area of proximal stent portions or distal stent portions adjacent the strut;

at least one ipsilateral graft extension having a fluid flow lumen disposed therein with the fluid flow lumen of the graft extension sealed to and in fluid communication with the fluid flow lumen of the ipsilateral leg of the main graft member; and

at least one contralateral graft extension having a fluid flow lumen disposed therein with the fluid flow lumen of the graft extension sealed to and in fluid communication with the fluid flow lumen of the contralateral leg of the main graft member.

2. The graft assembly of claim 1 wherein the main graft member has an axial length of about 5 cm to about 10 cm.

3. The graft assembly of claim 2 wherein the main graft member has an axial length of about 6 cm to about 8 cm.

4. The graft assembly of claim 1 wherein the fluid flow lumens of the graft extensions are overlapped with the fluid flow lumens of respective distal legs of the main graft member.

5. The graft assembly of claim 1 wherein the proximal stent of the proximal anchor member further comprises a plurality of barbs having sharp tissue engaging tips that are configured to extend in a radial outward direction in a deployed expanded state.

6. The graft assembly of claim 1 wherein the supple graft material of the main graft and graft extensions comprise layered porous or expanded PTFE.

7. The graft assembly of claim 1 wherein the graft extensions comprise an interposed self-expanding stent disposed between at least one outer layer and at least one inner layer of supple layers of graft material and wherein the interposed stent disposed between the outer layer and inner layer of graft material may be formed from an elongate resilient element helically wound with a plurality of longitudinally spaced turns into an open tubular configuration.

8. The graft assembly of claim 7 wherein the interposed stent is comprised of a superelastic alloy.

9. The graft assembly of claim 8 wherein the superelastic alloy comprises superelastic NiTi alloy.

10. The graft assembly of claim 7 wherein the graft material of each graft extension further comprises at least one axial zone of low permeability.

11. The graft assembly of claim 1 wherein the proximal stent portion of the proximal anchor member comprises a 4 crown stent.

12. The graft assembly of claim 1 wherein the distal stent portion of the proximal anchor member comprises an 8 crown stent.

13. The graft assembly of claim 1 wherein the proximal stent portion and distal stent portion of the proximal anchor member comprise a superelastic alloy.

14. The graft assembly of claim 13 wherein the superelastic alloy comprises superelastic NiTi alloy.

15. A modular endovascular graft assembly, comprising:

a bifurcated main graft member having an axial length of about 5 cm to about 10 cm formed from a supple graft material having a main fluid flow lumen therein, an ipsilateral leg with an ipsilateral fluid flow lumen in communication with the main fluid flow lumen and with an axial length of at least about 2 cm, a contralateral leg with a contralateral fluid flow lumen in communication with the main fluid flow lumen and with an axial length of at least about 2 cm, and a network of inflatable channels disposed on the main graft member including the ipsilateral and contralateral legs which is configured to accept a hardenable fill material to provide structural rigidity to the main graft member when the network of inflatable channels are in an inflated state and which includes at least one inflatable cuff disposed on a proximal portion of the main graft member configured to seal against an inside surface of a patient'"'"'s vessel;

a proximal anchor member disposed at a proximal end of the main graft member and secured to the main graft member and having a self-expanding proximal stent portion secured to a self-expanding distal stent portion with struts;

at least one ipsilateral graft extension having a fluid flow lumen disposed therein with the fluid flow lumen of the graft extension sealed to and in fluid communication with the fluid flow lumen of the ipsilateral leg of the main graft member; and

at least one contralateral graft extension having a fluid flow lumen disposed therein with the fluid flow lumen of the graft extension sealed to and in fluid communication with the fluid flow lumen of the contralateral leg of the main graft member.

16. The graft assembly of claim 15 wherein the main graft member has an axial length of about 6 cm to about 8 cm.

17. The graft assembly of claim 15 wherein the fluid flow lumens of the graft extensions are overlapped with the fluid flow lumens of respective distal legs of the main graft member.

18. The graft assembly of claim 15 wherein the proximal stent of the proximal anchor member further comprises a plurality of barbs having sharp tissue engaging tips that are configured to extend in a radial outward direction in a deployed expanded state.

19. The graft assembly of claim 15 wherein the supple graft material of the main graft and graft extensions comprise layered porous or expanded PTFE.

20. The graft assembly of claim 15 wherein the graft extensions comprise an interposed self-expanding stent disposed between at least one outer layer and at least one inner layer of supple layers of graft material and wherein the interposed stent disposed between the outer layer and inner layer of graft material may be formed from an elongate resilient element helically wound with a plurality of longitudinally spaced turns into an open tubular configuration.

21. The graft assembly of claim 20 wherein the interposed stent is comprised of a superelastic alloy.

22. The graft assembly of claim 21 wherein the superelastic alloy comprises superelastic NiTi alloy.

24. The graft assembly of claim 15 wherein the proximal stent portion of the proximal anchor member comprises a 4 crown stent.

25. The graft assembly of claim 15 wherein the distal stent portion of the proximal anchor member comprises an 8 crown stent.

26. The graft assembly of claim 15 wherein the proximal stent portion and distal stent portion of the proximal anchor member comprise a superelastic alloy.

27. The graft assembly of claim 26 wherein the superelastic alloy comprises superelastic NiTi alloy.

23. The graft assembly of embodiment 20 wherein the graft material of each graft extension further comprises at least one axial zone of low permeability.

28. A method of treating a patient, comprising:

providing a delivery catheter containing a radially constrained bifurcated main graft member formed from a supple graft material which has a main fluid flow lumen therein, which has an ipsilateral leg with an ipsilateral fluid flow lumen in communication with the main fluid flow lumen, which has a contralateral leg with a contralateral fluid flow lumen in communication with the main fluid flow lumen, which has a network of inflatable channels disposed on the main graft member including the ipsilateral and contralateral legs and which has a proximal anchor member disposed at a proximal end of the main graft member and secured to the main graft member and having a self-expanding proximal stent portion secured to a self-expanding distal stent portion;

axially positioning the delivery catheter within the patient'"'"'s vasculature such that the main graft member within the delivery catheter is disposed coextensively with a vascular defect of the patient'"'"'s aorta;

deploying the proximal anchor member so as to engage an inner surface of the patient'"'"'s vasculature and anchor the proximal anchor member to the patient'"'"'s aorta;

inflating the network of inflatable channels of the main graft member with an inflation material;

providing a second delivery catheter containing a radially constrained self-expanding contralateral graft extension;

axially positioning the second delivery catheter in the contralateral leg of the main graft member with a proximal portion of the contralateral graft extension axially overlapped with an inner fluid flow lumen of the contralateral leg of the main graft member and a distal portion of the contralateral graft extension axially overlapped with a portion of the patient'"'"'s contralateral iliac artery;

deploying the self-expanding contralateral graft extension by releasing the radial constraint so as to form a seal between the inner fluid flow lumen of the contralateral graft extension, a fluid flow lumen of the contralateral leg and a fluid flow lumen of the contralateral iliac artery;

providing a third delivery catheter containing a radially constrained self-expanding ipsilateral graft extension;

axially positioning the third delivery catheter in the ipsilateral leg of the main graft member with a proximal portion of the ipsilateral graft extension axially overlapped with an inner fluid flow lumen of the ipsilateral leg of the main graft member and a distal portion of the ipsilateral graft extension axially overlapped with a portion of the patient'"'"'s ipsilateral iliac artery; and

deploying the self-expanding ipsilateral graft extension by releasing the radial constraint so as to form a seal between the inner fluid flow lumen of the ipsilateral graft extension, a fluid flow lumen of the ipsilateral leg and a fluid flow lumen of the ipsilateral iliac artery.

29. A modular endovascular graft assembly, comprising:

a bifurcated main graft member formed from a supple graft material having a main fluid flow lumen therein, an ipsilateral leg with an ipsilateral fluid flow lumen in communication with the main fluid flow lumen, a contralateral leg with a contralateral fluid flow lumen in communication with the main fluid flow lumen and a network of inflatable channels disposed on the main graft member including the ipsilateral and contralateral legs which is configured to accept a hardenable fill material to provide structural rigidity to the main graft member when the network of inflatable channels are in an inflated state and which includes at least one inflatable cuff disposed on a proximal portion of the main graft member configured to seal against an inside surface of a patient'"'"'s vessel;

a proximal anchor member disposed at a proximal end of the main graft member and secured to the main graft member and having a self-expanding proximal stent portion secured to a self-expanding distal stent portion with struts having a cross sectional area that is substantially the same as or greater than a cross sectional area of proximal stent portions or distal stent portions adjacent the strut;

at least one ipsilateral graft extension having a fluid flow lumen disposed therein with the fluid flow lumen of the graft extension sealed to and in fluid communication with the fluid flow lumen of the ipsilateral leg of the main graft member; and

at least one contralateral graft extension having a fluid flow lumen disposed therein with the fluid flow lumen of the graft extension sealed to and in fluid communication with the fluid flow lumen of the contralateral leg of the main graft member.

30. A modular endovascular graft assembly, comprising:

a bifurcated main graft member having an axial length of about 5 cm to about 10 cm formed from a supple graft material having a main fluid flow lumen therein, an ipsilateral leg with an ipsilateral fluid flow lumen in communication with the main fluid flow lumen and with an axial length of at least about 2 cm, a contralateral leg with a contralateral fluid flow lumen in communication with the main fluid flow lumen and with an axial length of at least about 2 cm, and a network of inflatable channels disposed on the main graft member including the ipsilateral and contralateral legs which is configured to accept a hardenable fill material to provide structural rigidity to the main graft member when the network of inflatable channels are in an inflated state and which includes at least one inflatable cuff disposed on a proximal portion of the main graft member configured to seal against an inside surface of a patient'"'"'s vessel;

a proximal anchor member disposed at a proximal end of the main graft member and secured to the main graft member and having a self-expanding proximal stent portion secured to a self-expanding distal stent portion with struts;

at least one ipsilateral graft extension having a fluid flow lumen disposed therein with the fluid flow lumen of the graft extension sealed to and in fluid communication with the fluid flow lumen of the ipsilateral leg of the main graft member; and

at least one contralateral graft extension having a fluid flow lumen disposed therein with the fluid flow lumen of the graft extension sealed to and in fluid communication with the fluid flow lumen of the contralateral leg of the main graft member.

31. A graft extension, comprising

a fluid flow lumen disposed therein;

at least one layer of permeable PTFE material;

at least one layer of semi-permeable or substantially non-permeable PTFE material having no discernable node and fibril structure; and

an interposed self-expanding stent formed from an elongate resilient element helically wound with a plurality of longitudinally spaced turns into an open tubular configuration disposed between at least one outer layer and at least one inner layer of PTFE material.

32. The graft extension of claim 31 wherein the interposed stent is comprised of a superelastic alloy.

33. The graft extension of claim 32 wherein the superelastic alloy comprises superelastic NiTi alloy.

34. The graft extension of claim 31 wherein the graft material of each graft extension further comprises at least one axial zone of low permeability.

35. The graft extension of claim 31 wherein the permeable PTFE material comprises an inter nodal distance of about 10 microns to about 30 microns.

36. The graft extension of claim 31 wherein the permeable material has a thickness of about 0.00005 inch to about 0.005 inch.

37. The graft extension of claim 31 wherein the semi-permeable or substantially non-permeable material comprises a thickness of about 0.00005 inch to about 0.005 inch.

38. The graft extension of claim 31 wherein the semi-permeable or substantially non-permeable material comprises substantially low porosity and a closed cell microstructure with a plurality of interconnected high density regions having no discernable node and fibril structure between the high density regions.