ENDOVASCULAR ANASTOMOTIC CONNECTOR DEVICE, DELIVERY SYSTEM, AND METHODS OF DELIVERY AND USE

• US 20110066170A1
• Filed: 07/02/2010
• Published: 03/17/2011
• Est. Priority Date: 09/14/2009
• Status: Active Grant

• Current Assignee: Circulite Inc. (Medtronic Plc)
• Original Assignee: Circulite Inc. (Medtronic Plc)
• Inventors: Farnan, Robert C.
• Granted Patent: US 9,050,419 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 25/0668 splittable, tear apart

Abstract

An endovascular anastomotic connector and method of using the same. The endovascular anastomotic connector includes a vascular conduit and a supply conduit. The vascular conduit has proximal and distal ends that reside within a vascular structure. The supply conduit extends at an angle from the vascular conduit. The proximal end of the supply conduit is configured to be attached to an auxiliary device.

Claims

1. An anastomotic connector comprising:

a vascular conduit having a proximal end, a distal end, and a lumen extending therebetween, wherein the vascular conduit is configured to reside within a 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 the proximal end of the supply conduit is configured to extend from the vascular structure and couple to an auxiliary device.

2. The anastomotic connector of claim 1, wherein the vascular and supply conduits include support structures constructed from a continuous wire, a hypotube, or a rolled sheet stock.

3. The anastomotic connector of claim 2, wherein the support structures are encapsulated by an expandable material.

4. The anastomotic connector of claim 3, wherein the expandable material is comprised of a self-expanding material.

5. The anastomotic connector of claim 4, wherein the self-expanding material is nickel titanium.

6. The anastomotic connector of claim 3, wherein the expandable material is comprised of a balloon-expanding material.

7. The anastomotic connector of claim 6, wherein the balloon-expanding material is a metallic-based material.

8. The anastomotic connector of claim 3, wherein the expandable material is coated with a porous material.

9. The anastomotic connector of claim 8, wherein the porous material is expanded polytetrafluoroethylene, woven polyester, velour, or DACRON brand of synthetic polyester fabric.

10. The anastomotic connector of claim 1, wherein an angle created by the bifurcation joint ranges from about 5 degrees to about 90 degrees.

11. The anastomotic connector of claim 1, wherein the auxiliary device is a pump.

12. The anastomotic connector of claim 11, wherein the pump is also connected to an inflow cannula.

13. The anastomotic connector of claim 12, wherein the inflow cannula is an endovascular cannula that extends to an intra-atrial septum in the heart of a patient.

14. The anastomotic connector of claim 12, wherein the inflow cannula is a surgically positioned cannula that extends to a chamber of the heart of a patient.

15. A delivery system comprising the anastomotic connector of claim 1 and a delivery subassembly, the delivery subassembly comprising:

a multi-lumen hub;

a multi-lumen delivery shaft configured to extend from the multi-lumen hub, through the lumen of the supply conduit, through the lumen of the distal end of the vascular conduit, and distally from the distal end of the vascular conduit; and

a secondary delivery shaft configured to extend from the multi-lumen hub, into the proximal end of the vascular conduit, through the lumen of the vascular conduit, and distally from the distal end of the vascular conduit, wherein a distal portion of the secondary delivery shaft is received by a first lumen of the multi-lumen delivery shaft.

16. The delivery system of claim 15, wherein the first lumen is slotted and configured to receive the secondary delivery shaft.

17. The delivery system of claim 15, wherein the multi-lumen delivery shaft further includes a second lumen for receiving a guide-wire.

18. The delivery system of claim 15 further comprising:

a delivery sheath configured to receive the delivery system and to move relative thereto.

19. The delivery system of claim 18, wherein the delivery sheath is constructed of a peel-away sheath design.

20. An anastomotic connector comprising:

a vascular stent having a proximal end, a distal end, and a lumen extending therebetween, the vascular stent configured to reside within a 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 stent and the proximal end of the supply conduit is configured to couple to a pump of a circulatory assist system.

21. A delivery system for a bifurcated stent having a body portion and a branch portion extending angularly from the body portion, the delivery system comprising:

a multi-lumen hub;

a multi-lumen delivery shaft configured to extend from the multi-lumen hub, through a lumen of the branch portion, through the lumen of a distal end of the body portion, and distally from the distal end of the body portion; and

a secondary delivery shaft configured to extend from the multi-lumen hub, into a proximal end of the body portion, through the lumen of the body portion, and distally from the distal end of the body portion, wherein a distal portion of the secondary delivery shaft is received by a first lumen of the multi-lumen delivery shaft.

22. The delivery system of claim 21 further comprising:

a delivery sheath configured to receive the delivery system and to move relative thereto.

23. A method of connecting a peripheral vessel to an auxiliary device with an anastomotic connector comprising a vascular conduit and a supply conduit, the vascular conduit having proximal and distal ends and is configured to reside within the peripheral vessel, the supply conduit having proximal and distal ends, wherein the distal end of the supply conduit forms a bifurcation joint with the vascular conduit and the proximal end of the supply conduit is configured to couple to the auxiliary device, the method comprising:

loading the anastomotic connector onto a delivery subassembly;

directing the delivery subassembly with the anastomotic connector into the peripheral vessel;

deploying the vascular conduit within the peripheral vessel;

deploying the supply conduit;

retracting the delivery subassembly; and

connecting the auxiliary device to the proximal end of the supply conduit.

24. The method according to claim 23, wherein loading the anastomotic connector includes wrapping the proximal end of the vascular conduit around the supply conduit.

25. The method according to claim 23, wherein the delivery subassembly comprises:

a multi-lumen hub;

a multi-lumen delivery shaft configured to extend from the multi-lumen hub, through a lumen of the supply conduit, through a lumen of the distal end of the vascular conduit, and distally from the distal end of the vascular conduit; and

a secondary delivery shaft configured to extend from the multi-lumen hub, into the proximal end of the vascular conduit, through a lumen of the vascular conduit, and distally from the distal end of the vascular conduit, wherein a distal portion of the secondary delivery shaft is received by a first lumen of the multi-lumen delivery shaft.

26. The method according to claim 25 further comprising:

creating an incision into the peripheral vessel and maintaining the incision with an introducer before directing the delivery subassembly with the anastomotic connector into the peripheral vessel.

27. The method according to claim 26 further comprising:

directing a first guide-wire through a second lumen of the multi-lumen delivery shaft, into the introducer, and into the peripheral vessel; and

advancing the delivery subassembly with the anastomotic connector over the first guide-wire and into the peripheral vessel.

28. The method according to claim 27 further comprising:

creating a secondary incision site that is remotely located from the incision in the peripheral vessel;

directing a second guide-wire percutaneously from the secondary incision site to the anastomotic connector within the peripheral vessel; and

directing the second guide-wire through the vascular conduit after the vascular conduit is deployed.

29. The method according to claim 23, wherein the delivery subassembly is received by a delivery sheath and moves relative thereto.

30. The method according to claim 29, wherein the deploying steps include retracting the delivery sheath.

31. The method according to claim 23, wherein the vascular and supply conduits include support structures constructed from a continuous wire, a hypotube, or a rolled sheet stock.

32. The method according to claim 31 further comprising:

directing a balloon dilation catheter through the supply conduit to the vascular conduit, after the delivery subassembly is retracted;

inflating the balloon dilation catheter to expand the support structures of the vascular conduit; and

deflating and removing the balloon delivery conduit before connecting the auxiliary device to the proximal end of the supply conduit.

33. The method according to claim 31 further comprising:

directing a balloon dilation catheter into the supply conduit after the delivery subassembly is retracted;

inflating the balloon dilation catheter to expand the support structures of the supply conduit at the bifurcation joint; and

deflating and removing the balloon delivery catheter before connecting the auxiliary device to the proximal end of the supply conduit.

34. The method according to claim 23 further comprising:

capping a proximal end of the supply conduit after retracting the delivery subassembly.

35. The method according to claim 34 further comprising:

deairing the supply conduit before removing the cap and connecting the auxiliary device.

36. The method according to claim 23, wherein the auxiliary device is a pump.

37. A method of connecting a peripheral vessel to an auxiliary device with an anastomotic connector comprising a vascular conduit and a supply conduit, the vascular conduit having proximal and distal ends and is configured to reside within the peripheral vessel, the supply conduit having proximal and distal ends, wherein the distal end of the supply conduit forms a bifurcation joint with the vascular conduit and the proximal end of the supply conduit is configured to couple to the auxiliary device, the method comprising:

(i) coupling the anastomotic connector to a delivery subassembly, the delivery subassembly comprising a multi-lumen hub, a multi-lumen delivery shaft extending distally form the multi-lumen hub, and a secondary delivery shaft extending distally from the multi-lumen hub, wherein a distal portion of the secondary delivery shaft is received by a first lumen of the multi-lumen delivery shaft, the coupling including;

(a) directing the multi-lumen delivery shaft from the proximal end of the supply conduit, through the lumen of the supply conduit, through the lumen of the distal end of the vascular conduit, and distally from the distal end of the vascular conduit;

(b) directing the secondary delivery shaft into the distal end of the vascular conduit, through the lumen of the vascular conduit, and distally from the distal end of the vascular conduit, wherein a distal portion of the secondary delivery shaft is received by a first lumen of the multi-lumen delivery shaft;

(c) wrapping the proximal end of the vascular conduit around the supply conduit; and

(d) backloading the coupled anastomotic connector with the delivery subassembly into a delivery sheath;

(ii) directing the delivery sheath with the coupled anastomotic connector and delivery subassembly into the peripheral vessel;

(iii) retracting the delivery sheath to thereby deploy the proximal and distal ends of the vascular conduit within the peripheral vessel;

(iv) continuing the retracting to deploy the supply conduit;

(v) retracting the delivery sheath and the delivery subassembly from the anastomotic connector;

(vi) deairing the supply conduit; and

(vii) connecting the auxiliary device to the proximal end of the supply conduit.