Cannula lined with tissue in-growth material

• US 9,750,866 B2
• Filed: 08/05/2011
• Issued: 09/05/2017
• Est. Priority Date: 02/11/2010
• Status: Active Grant

• Current Assignee: Circulite Inc. (Medtronic Plc)
• Original Assignee: Circulite Inc. (Medtronic Plc)
• Inventors: Farnan, Robert C., Marseille, Oliver
• Primary Examiner(s): Wehrheim, Lindsey G
• Application Number:
  US13/204,201
• Publication Number:
  US 20120004496A1
• Time in Patent Office: 2,223 Days
• Field of Search: 600 16- 18, 604 8- 10, 604264-271, 604507, 604508, 604523-539
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube
• CPC Class Codes: A61M 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body

Abstract

A cannula for moving fluids between a pump and the circulatory system of a patient. The cannula includes a liner having an intermediate portion between a proximal portion and a distal portion, and a lumen extending between the proximal and distal portions. At least the intermediate portion of the liner is constructed from a tissue in-growth material for supporting the growth of endothelial cells. A jacket surrounds at least part of the liner.

Claims

1. A cannula configured to move blood between a pump and a circulatory system of a patient, the cannula comprising:

a liner comprising an intermediate portion between a proximal portion and a distal portion and a lumen extending between the proximal and distal portions, wherein at least the intermediate portion is constructed from a tissue in-growth material adapted to contact blood flowing through the lumen configured to support the growth of endothelial cells, the proximal portion is configured for connecting to the pump and the distal portion is configured for connecting to the circulatory system;

a jacket fully encapsulating the liner;

an outer layer surrounding at least a part of the jacket, wherein the outer layer is constructed from the tissue in-growth material;

wherein the outer layer has a proximal and a distal end and an intermediate portion therebetween; and

a polymeric layer extending along a partial length of the liner and the outer layer, the polymeric layer having a first portion that extends proximally from the proximal end of the outer layer to a proximal end of the cannula and a second portion that extends distally from the distal end of the outer layer to the distal end of the cannula such that the first and second portions of the polymeric layer encapsulate the proximal and distal ends of the outer layer to prevent delamination of the outer layer from the jacket, the first and second portions of the polymeric layer further encapsulating a proximal and a distal portion of the jacket without encapsulating the intermediate portion of the outer layer.

2. The cannula of claim 1, wherein the tissue in-growth material is an expanded polytetrafluoroethylene, a porous polymeric material, a woven polyester material, or a velour.

3. The cannula of claim 1, wherein the proximal and distal portions of the liner are constructed from an elastomeric material.

4. The cannula of claim 1, wherein the jacket is constructed from a polymeric material and is bonded to the liner.

5. The cannula of claim 1, wherein the distal portion of the liner is constructed from the tissue in-growth material.

6. The cannula of claim 1, wherein the liner is constructed as a unitary structure having the distal, intermediate, and proximal portions constructed from the tissue in-growth material.

7. The cannula of claim 1 further comprising:

a reinforcing structure surrounding at least a part of the intermediate portion of the liner and configured to resist kinks along the length of the cannula, wherein the liner and the jacket encapsulate the reinforcing structure.

8. The cannula of claim 1 further comprising:

one or more longitudinal strengtheners positioned between the liner and the jacket, and extending at least partially between the proximal and distal portions.

9. The cannula of claim 1, wherein the outer layer is bonded to the jacket.

10. A cannula configured to move blood between a pump and the circulatory system of a patient, the cannula comprising:

a liner comprising an intermediate portion between a proximal portion and a distal portion and a lumen extending between the proximal and distal portions, wherein at least the intermediate portion is constructed from a tissue in-growth material adapted to contact blood flowing through the lumen configured to support the growth of endothelial cells, the proximal portion is configured for connecting to the pump and the distal portion is configured for connecting to the circulatory system;

a reinforcing structure surrounding at least a part of the intermediate portion of the liner and configured to resist kinks along the length of the cannula; and

a jacket surrounding the reinforcing structure and fully encapsulating the liner;

an outer layer surrounding at least a part of the jacket, wherein the outer layer is constructed from the tissue in-growth material, the outer layer including a proximal and a distal end and an intermediate portion therebetween; and

a polymeric layer extending along a partial length of the liner and the outer layer, the polymeric layer having a first portion that extends proximally from the proximal end of the outer layer to a proximal end of the cannula and a second portion that extends distally from the distal end of the outer layer to a distal end of the cannula such that the first and second portions of the polymeric layer encapsulate the proximal and distal ends of the outer layer to prevent delamination of the outer layer from the jacket, the first and second portions of the polymeric layer further encapsulating the proximal and distal portions of the jacket without encapsulating the intermediate portion of the outer layer.

11. The cannula of claim 10, wherein the tissue in-growth material is a porous polymeric material, a woven polyester material, expanded polytetrafluoroethylene, or a velour.

12. The cannula of claim 10, wherein the liner is constructed as a unitary structure having the distal, intermediate, and proximal portions constructed from the tissue in-growth material.

13. The cannula of claim 10, wherein the jacket is constructed from a polymeric material and is bonded to the liner.

14. The cannula of claim 10, wherein the jacket fully encapsulates the proximal and distal portions of the liner.

15. The cannula of claim 10, wherein the outer layer is bonded to the jacket.

16. An inflow cannula configured to move blood from the heart of a patient to a pump, the inflow cannula comprising:

a liner comprising an intermediate portion between a proximal portion and a distal portion and a lumen extending between the proximal and distal portions, wherein at least the intermediate portion is constructed from a tissue in-growth material adapted to contact blood flowing through the lumen configured to support the growth of endothelial cells;

wherein the distal and proximal portions are constructed from the tissue in-growth material, and the distal and proximal portions of the liner have an outer diameter that is greater than an outer diameter of the intermediate portion of the liner so as to define a channel at the intermediate portion, the channel having an outer diameter that is smaller than the outer diameter of the distal and proximal portions;

an intermediate polymeric layer disposed in the channel;

a jacket fully encapsulating the intermediate polymeric layer;

a tip coupled to the distal portion and configured to be inserted through a wall of the heart; and

a hub coupled to the proximal portion and configured to secure the inflow cannula to the pump.

17. The cannula of claim 16, further comprising:

a reinforcement structure positioned in the channel between the liner and the intermediate polymeric layer so as to form a layering of the liner, the reinforcement structure, the intermediate polymeric layer, and the jacket.

18. An outflow cannula configured to move blood from a pump to an arterial structure within the vascular network of a patient, the outflow cannula comprising:

a liner comprising an intermediate portion between a proximal portion and a distal portion and a lumen extending between the proximal and distal portions, wherein at least the intermediate portion is constructed from a tissue in-growth material adapted to contact blood flowing through the lumen configured to support the growth of endothelial cells;

wherein the distal and proximal portions are constructed from the tissue in-growth material, and the distal and proximal portions of the liner have an outer diameter that is greater than an outer diameter of the intermediate portion of the liner so as to define a channel at the intermediate portion, the channel having an outer diameter that is smaller than the outer diameter of the distal and proximal portions;

an intermediate polymeric layer disposed in the channel;

a jacket fully encapsulating the intermediate polymeric layer;

a hub coupled to the proximal portion and configured to secure the outflow cannula to the pump; and

a distal end that is configured to be coupled to the arterial structure.

19. The cannula of claim 18, further comprising:

a reinforcement structure positioned in the channel between the liner and the intermediate polymeric layer so as to form a layering of the liner, the reinforcement structure, the intermediate polymeric layer, and the jacket.

20. A cannula for moving blood between a pump and a circulatory system of a patient, the cannula comprising:

a liner constructed from a polymer material and including an inner blood contacting surface;

a jacket fully encapsulating the liner and constructed from a polymer material; and

an intermediate layer between the liner and the jacket, the intermediate layer being constructed from a porous material;

wherein neither the inner blood contacting surface of the liner nor the jacket supports tissue in-growth thereon.

21. The cannula of claim 20, wherein the porous material is an expanded polytetrafluoroethylene, a porous polymeric material, a woven polyester material, or a velour.

22. The cannula of claim 20 further comprising:

a reinforcing structure surrounding at least a part of an intermediate portion of the liner configured to resist kinks along a length of the cannula.

23. A cannula configured to move blood between a pump and a circulatory system of a patient, the cannula comprising:

a liner comprising a proximal portion, a distal portion, an intermediate portion located between the proximal and distal portions, and a lumen extending between the proximal and distal portions, wherein at least the intermediate portion is constructed from a tissue in-growth material adapted to contact blood flowing through the lumen configured to support the growth of endothelial cells, the proximal portion is configured for connecting to the pump and the distal portion is configured for connecting to the circulatory system;

a jacket fully encapsulating the liner;

wherein the distal and proximal portions are constructed from the tissue in-growth material and each have an outer diameter that is greater than an outer diameter of the intermediate portion of the liner so as to define a channel at the intermediate portion, the channel having an outer diameter that is smaller than the outer diameter of the distal and proximal portions; and

an intermediate polymeric layer disposed in the channel and fully encapsulated by the jacket.

24. The cannula of claim 23, further comprising:

a reinforcement structure positioned in the channel between the liner and the intermediate polymeric layer so as to form a layering of the liner, the reinforcement structure, the intermediate polymeric layer, and the jacket.