Endovascular anastomotic connector device, delivery system, and methods of delivery and use

• US 9,050,419 B2
• Filed: 07/02/2010
• Issued: 06/09/2015
• 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.
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US12/829,425
• Publication Number:
  US 20110066170A1
• Time in Patent Office: 1,803 Days
• Field of Search: 606/151, 606/153, 623/1.1, 623/1.11, 623/1.35, 604/8, 604/284
• US Class Current: 1/1
• 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. A delivery system comprising:

an anastomotic connector for establishing a fluid connection between an auxiliary device and an existing vascular structure of a patient, the connector including;

a vascular conduit having a proximal end, a distal end, a lumen extending therebetween, and first and second expandable support structures respectively located at the proximal and distal ends of the vascular conduit, the first and second expandable support structures configured to be inserted through an incision in the existing vascular structure of the patient wherein the vascular conduit is configured to reside within the existing vascular structure; and

a supply conduit having a proximal end, a distal end, a lumen extending therebetween, and a third expandable support structure located at the distal end of the supply conduit, wherein the distal end of the supply conduit forms a bifurcation joint with the vascular conduit, the lumen of the supply conduit extends from the bifurcation joint and is configured to extend from the existing vascular structure, and the proximal end is configured to couple to an auxiliary device, and wherein the third expandable support structure is expandable to seal the incision in the existing vascular structure at the bifurcation joint;

wherein, with the supply conduit coupled to the vascular conduit, the vascular conduit is configured to be directed into the existing vascular structure and the first and second expandable support structures then expanded to secure the vascular conduit within the existing vascular structure; and

a delivery subassembly including;

a multi-lumen hub;

a multi-lumen delivery shaft coupled to the multi-lumen hub, a first lumen of the multi-lumen delivery shaft being co-extensive with at least one lumen of the multi-lumen hub, the multi-lumen delivery shaft being configured to extend 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 second lumen of the multi-lumen delivery shaft.

2. The delivery system of claim 1, wherein the first, second and third expandable support structures are constructed from a continuous wire, a hypotube, or a rolled sheet stock.

3. The delivery system of claim 2, wherein the first, second and third expandable support structures are encapsulated by an expandable material.

4. The delivery system of claim 3, wherein the first, second and third expandable support structures are comprised of a self-expanding material.

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

6. The delivery system of claim 3, wherein the first, second and third expandable support structures are comprised of a balloon-expanding material.

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

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

9. The delivery system of claim 8, wherein the porous material is expanded polytetrafluoroethylene, polyester, or velour.

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

11. The delivery system of claim 1, wherein the auxiliary device is a pump.

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

13. The delivery system 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 delivery system of claim 12, wherein the inflow cannula is a surgically positioned cannula that extends to a chamber of the heart of a patient.

15. The delivery system of claim 1, wherein the vascular conduit is configured to reside within the vascular structure adjacent the incision.

16. The delivery system of claim 1, wherein the second lumen is slotted and configured to receive the secondary delivery shaft.

17. The delivery system of claim 1, wherein the multi-lumen delivery shaft further includes a third lumen for receiving a guide-wire.

18. A delivery system comprising:

an anastomotic connector for establishing a fluid connection between a pump of a circulatory assist system and an existing vascular structure of a patient, the connector including;

a vascular stent having a proximal end, a distal end, a lumen extending therebetween, and first and second expandable support structures respectively located at the proximal and distal ends of the vascular stent, the first and second expandable support structures configured to be inserted through an incision in the existing vascular structure of the patient, the vascular stent configured to reside within the existing vascular structure; and

a supply conduit having a proximal end, a distal end, a lumen extending therebetween, and a third expandable support structure located at the distal end of the supply conduit, wherein the distal end of the supply conduit forms a bifurcation joint with the vascular stent, the lumen of the supply conduit extends from the bifurcation joint and the proximal end of the supply conduit is configured to couple to a pump of a circulatory assist system, and wherein the third expandable support structure is expandable to seal the incision in the existing vascular structure at the bifurcation joint;

wherein, with the supply conduit coupled to the vascular stent, the vascular conduit is configured to be directed into the existing vascular structure and the first and second expandable support structures then expanded for securing the vascular conduit within the existing vascular structure; and

a delivery subassembly including;

a multi-lumen hub;

a multi-lumen delivery shaft coupled to the multi-lumen hub, a first lumen of the multi-lumen delivery shaft being co-extensive with at least one lumen of the multi-lumen hub, the multi-lumen delivery shaft being configured to extend 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 second lumen of the multi-lumen delivery shaft.

19. The delivery system of claim 18, wherein the vascular stent is configured to reside within the vascular structure adjacent the incision.