Two piece endovascular anastomotic connector

• US 8,333,727 B2
• Filed: 08/31/2010
• Issued: 12/18/2012
• Est. Priority Date: 10/08/2009
• Status: Active Grant

• Current Assignee: Circulite Inc. (Medtronic Plc)
• Original Assignee: Circulite Inc. (Medtronic Plc)
• Inventors: Farnan, Robert C.
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US12/872,394
• Publication Number:
  US 20110087063A1
• Time in Patent Office: 840 Days
• Field of Search: 600 16- 18, 604/8, 60416411-16413
• US Class Current: 604/8
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae

Abstract

An anastomotic connector comprising an endovascular component including a vascular conduit and a supply conduit and a cannula component. The vascular conduit has first and second ends that are configured to reside within a vascular structure. The supply conduit has proximal and distal ends, where the distal end fluidicly connects to the vascular conduit between the first and second ends. The cannula component, which also includes proximal and distal ends, is received by the supply conduit.

Claims

1. An anastomotic connector comprising:

(i) an endovascular component comprising;

a vascular conduit including first and second ends and a lumen extending therebetween, wherein the vascular conduit is configured to be inserted through an incision in an existing vascular structure and reside within the existing vascular structure; and

a supply conduit having a proximal end, a distal end, a lumen extending therebetween, and wherein the distal end of the supply conduit forms a bifurcation joint with the vascular conduit and fluidicly connects to the lumen of the vascular conduit between the first and second ends; and

(ii) a cannula component having a proximal end, a distal end, a lumen extending therebetween, and a seal ring at the distal end, wherein the cannula component is adapted to be received by the supply conduit and extend proximally therefrom and wherein the seal ring expands to seal the incision in the existing vascular structure at the bifurcation joint when the cannula component is engaged with the supply conduit.

2. The anastomotic connector of claim 1, further comprising:

a hub coupled to the proximal end of the cannula component, the hub being configured to connect to an auxiliary device.

3. The anastomotic connector of claim 2, wherein a length of the hub is adjustable.

4. The anastomotic connector of claim 2, wherein the auxiliary device is an implantable pump.

5. The anastomotic connector of claim 1, wherein the first and second ends of the vascular conduit include reinforcement structures.

6. The anastomotic connector of claim 5, wherein the reinforcement structures are constructed from a self expanding material.

7. The anastomotic connector of claim 5, wherein the reinforcement structures are constructed from a balloon-expanding material.

8. The anastomotic connector of claim 5, wherein the reinforcement structures are encapsulated in a porous polymeric biomaterial capable of promoting tissue in-growth.

9. The anastomotic connector of claim 1, wherein the first and second ends of the vascular conduit are flared.

10. The anastomotic connector of claim 1, wherein the supply conduit further comprises:

a major diameter section; and

a minor diameter section, wherein the minor diameter section is distal to the major diameter section.

11. The anastomotic connector of claim 10, wherein a transition section couples the larger major diameter section to the smaller minor diameter section when the anastomotic connector is directed into the existing vascular structure having an inner diameter that is smaller than a diameter of the major diameter section.

12. The anastomotic connector of claim 11, wherein the transition section provides a positive stop to the cannula component.

13. The anastomotic connector of claim 12, wherein a transition section of the cannula component couples the larger major diameter section of the cannula component to the smaller minor diameter section of the cannula component.

14. The anastomotic connector of claim 13, wherein the transition section of the cannula component is received by a transition section of the supply conduit, wherein the transition section of the supply conduit couples the larger major diameter section of the supply conduit to the smaller minor diameter section of the supply conduit.

15. The anastomotic connector of claim 10, wherein a diameter of a lumen of the minor diameter section is substantially similar to a diameter of the lumen of the vascular conduit.

16. The anastomotic connector of claim 10, wherein a length of the minor diameter section is equal to or exceeds a wall thickness of the existing vascular structure.

17. The anastomotic connector of claim 10, wherein the cannula component further comprises:

a major diameter section received by the major diameter section of the supply conduit; and

a minor diameter section, wherein the minor diameter section is distal to the major diameter section and the minor diameter section is received by the minor diameter section of the supply conduit.

18. The anastomotic connector of claim 17, wherein the minor diameter section includes at least one seal ring creating a fluidic seal by interference fit with the minor diameter of the supply conduit.

19. The anastomotic connector of claim 18, wherein the endovascular component is configured to be collapsible so as to be loaded into a delivery system and to move relative thereto.

20. The anastomotic connector of claim 19, wherein the delivery system includes a delivery catheter that is directed through the endovascular component and a delivery sheath that receives the delivery catheter and the endovascular component.

21. The anastomotic connector of claim 1, wherein the supply conduit is constructed from a porous polymeric biomaterial capable of promoting tissue in-growth.

22. The anastomotic connector of claim 1, wherein the cannula component includes a metallic support in a wall of the cannula component.

23. The anastomotic connector of claim 22, wherein the metallic support is a coil or a braid.

24. The anastomotic connector of claim 1, wherein the cannula component is constructed from a thermoplastic or a thermoset material.

25. The anastomotic connector of claim 1, wherein a diameter of the vascular conduit is substantially similar to a diameter of the vascular structure.

26. A method of connecting an auxiliary device to an existing vascular structure with an anastomotic connector, the anastomotic connector comprising:

(a) an endovascular component comprising a vascular conduit having first and second ends and a lumen extending therebetween, wherein the vascular conduit is configured to be inserted through an incision in the existing vascular structure and reside within the existing vascular structure and a supply conduit having a proximal end, a distal end, and a lumen extending therebetween, wherein the distal end of the supply conduit forms a bifurcation joint with the vascular conduit and fluidicly connects to the lumen of the vascular conduit between the first and second ends; and

(b) a cannula component having a proximal end, a distal end, and a lumen extending therebetween, wherein the cannula component is adapted to be received by the supply conduit and extend proximally therefrom, a seal ring at the distal end of the cannula component, and a hub coupled to the proximal end of the cannula component the hub being configured to connect to the auxiliary device, the method comprising;

(i) advancing the endovascular component into the vascular structure;

(ii) deploying the first and second ends of the vascular conduit within the vascular structure;

(iii) deploying the supply conduit;

(iv) advancing the cannula component into the supply conduit of the endovascular component thereby expanding the seal ring and sealing the incision at the bifurcation joint; and

(v) coupling the hub of the cannula component to the auxiliary device.

27. The method according to claim 26 further comprising:

adjusting a length of the hub of the cannula component before coupling the hub to the auxiliary device.

28. The method according to claim 26 further comprising:

sealing the vascular conduit against an incision in the vascular structure by manipulating the endovascular component before deploying the supply conduit.

29. The method according to claim 26, wherein the first and second ends of the vascular conduit include reinforcement structures.

30. The method according to claim 29 further comprising:

advancing a balloon catheter into the vascular conduit before advancing the cannula component;

inflating a balloon portion of the balloon catheter to expand the reinforcement structures; and

retracting the balloon catheter.

31. A method of connecting an auxiliary device to an existing vascular structure with an anastomotic connector, the anastomotic connector comprising:

(a) an endovascular component comprising a vascular conduit having first and second ends and a lumen extending therebetween, wherein the vascular conduit is configured to be inserted through an incision in the existing vascular structure and reside within the vascular structure and a supply conduit having a proximal end, a distal end, and a lumen extending therebetween, wherein the distal end of the supply conduit forms a bifurcation joint with the vascular conduit and fluidicly connects to the lumen of the vascular conduit between the first and second ends; and

(b) a cannula component having a proximal end, a distal end, and a lumen extending therebetween, wherein the cannula component is adapted to be received by the supply conduit and extend proximally therefrom, a seal ring at the distal end of the cannula component, and a hub coupled to the proximal end of the cannula component, the hub being configured to connect to the auxiliary device, the method comprising;

(i) creating an incision in the vascular structure;

(ii) loading the endovascular component into a delivery system;

(iii) directing a guide-wire into the vascular structure and then advancing an introducer over the guide-wire to maintain the incision;

(iv) advancing the endovascular component with the delivery system over the guide-wire and into the vascular structure;

(v) deploying the first and second ends of the vascular conduit within the vascular structure;

(vi) sealing the incision with the endovascular component;

(vii) deploying the supply conduit;

(viii) advancing the cannula component into the supply conduit thereby expanding the seal ring and sealing the incision at the bifurcation joint;

(ix) retracting the introducer and the guide-wire from the incision; and

(x) coupling the hub of the cannula component to the auxiliary device.