Cannula lined with tissue in-growth material and method of using the same

• US 9,504,776 B2
• Filed: 02/11/2011
• Issued: 11/29/2016
• 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): Levicky, William
• Assistant Examiner(s): Hankins, Lindsey G
• Application Number:
  US13/025,845
• Publication Number:
  US 20110196191A1
• Time in Patent Office: 2,118 Days
• Field of Search: 607/116
• US Class Current: 1/1
• 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: A61F 2210/0076 multilayered, e.g. laminated structures
• 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 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• 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 60/205 Non-positive displacement blood pumps
• 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 for moving blood between a pump and the circulatory system of a patient, the cannula comprising:

a liner having a length and comprising an intermediate portion that extends for a majority of the length 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 porous in-growth material that permits embedment therein of endothelial cells of blood flowing through the lumen to thereby reduce thrombus formations along an inner blood contacting surface of the cannula, 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; and

a continuous outer layer bonded to and surrounding the jacket and extending along a full length of the intermediate and distal portions of the liner, the outer layer constructed from a porous in-growth material that permits embedment therein of endothelial cells of blood flowing along an outer blood contacting surface of the cannula to thereby reduce thrombus formations along the outer blood contacting surface.

2. The cannula of claim 1, wherein the porous in-growth material is an expanded polytetrafluoroethylene.

3. The cannula of claim 1, wherein the porous in-growth material is a porous polymeric material, a woven polyester material, or a velour.

4. The cannula of claim 1, wherein the proximal and distal portions of the liner are constructed from a polymer material.

5. The cannula of claim 4, wherein the polymer material is an elastomeric material.

6. The cannula of claim 5, wherein the elastomeric material is a polyurethane or a silicone.

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

8. The cannula of claim 7, wherein an outer surface of the liner is coated with a compatible polyurethane or silicone solution before it is bonded to the jacket.

9. The cannula of claim 7, wherein the jacket is constructed from a polyurethane and is bonded to the liner by a melt process.

10. The cannula of claim 7, wherein the jacket is constructed from a silicone and is bonded to the liner by a cross-linking process.

11. The cannula of claim 1, wherein the distal portion is also constructed from the porous in-growth material.

12. The cannula of claim 11, wherein the diameter of porous in-growth material comprising the distal portion is larger than the diameter of the porous in-growth material comprising the intermediate portion.

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

14. The cannula of claim 1 further comprising:

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

15. The cannula of claim 14, wherein the reinforcing structure is a coil or a braid.

16. The cannula of claim 15, wherein the coil or braid is constructed from stainless steel, chromium cobalt, a superelastic material, or a rigid polymeric material.

17. The cannula of claim 1 further comprising:

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

18. The cannula of claim 17, wherein the one or more longitudinal strengtheners includes one or more suture strands.

19. The cannula of claim 1 further comprising:

a proximally-positioned hub for securing the cannula to the pump.

20. The cannula of claim 1 further comprising:

a distally-positioned tip, wherein the distally-positioned tip is configured to be inserted through a wall of one of the heart, an artery, or a vein of the patient.

21. The cannula of claim 20, wherein the distally-positioned tip has an outer surface and at least a portion of the outer surface includes a porous in-growth material.

22. The cannula of claim 20, wherein the distally-positioned tip includes at least one anchor that extends radially from the distally-positioned tip and is configured to resist a proximally-directed force applied to the cannula.

23. The cannula of claim 22, wherein the distally-positioned tip has an outer surface including a porous in-growth material adjacent to the at least one anchor.

24. The cannula of claim 23, wherein the porous in-growth material on the outer surface further includes a prothrombotic coating.

25. The cannula of claim 22, wherein the distally-positioned tip is secured to the cannula by at least one barb, at least one suture, or at least one band.

26. The cannula of claim 25, wherein the at least one band further includes a porous in-growth material.

27. The cannula of claim 1, wherein at least a part of the distal portion of the liner is configured to create an anastomotic connection with a wall of one of the heart, an artery, or a vein.

28. The cannula of claim 1, wherein the cannula includes a distal end and a proximal end and a tapered inner diameter extending therebetween.

29. The cannula of claim 1, wherein the porous in-growth material from which the liner and the outer layer are constructed is a thermoset material and the jacket is constructed from a thermoplastic material, and the jacket is bonded to the liner and the outer layer with application of heat.

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

a liner having a length and comprising an intermediate portion that extends for a majority of the length 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 porous in-growth material that permits embedment therein of endothelial cells of blood flowing through the lumen to thereby reduce thrombus formations along an inner blood contacting surface of the cannula, 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 for resisting kinks along the length of the cannula;

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

a continuous outer layer bonded to and surrounding the jacket and extending along a full length of the intermediate and distal portions of the liner, the outer layer constructed from a porous in-growth material that permits embedment therein of endothelial cells of blood flowing along an outer blood contacting surface of the cannula to thereby reduce thrombus formations along the outer blood contacting surface.

31. The cannula of claim 30, wherein the porous in-growth material is a porous polymeric material, a woven polyester material, or a velour.

32. The cannula of claim 30, wherein the proximal and distal portions of the liner are constructed from a polymer material.

33. The cannula of claim 30, wherein the liner is constructed as a unitary structure having the distal, intermediate, and proximal portions constructed from the porous in-growth material.

34. The cannula of claim 30, wherein the reinforcing structure is constructed from stainless steel, chromium cobalt, a superelastic material, or a rigid polymeric material.

35. The cannula of claim 30, wherein the jacket is constructed from a polymeric material and is bonded to the liner.

36. The cannula of claim 30 further comprising:

a distally-positioned tip, wherein the distally-positioned tip is configured to be inserted through a wall of one of the heart, an artery, or a vein of the patient.

37. The cannula of claim 36, wherein the distally-positioned tip has an outer surface and at least a portion of the outer surface includes a porous in-growth material.

38. The cannula of claim 36, wherein the distally-positioned tip is secured to the cannula by at least one barb, at least one suture, or at least one band.

39. The cannula of claim 30 further comprising:

a proximally-positioned hub for connecting the cannula to the pump.

40. The cannula of claim 30 further comprising:

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

41. An inflow cannula for moving blood from the heart of a patient to a pump, the inflow cannula comprising:

a liner having a length and comprising an intermediate portion that extends for a majority of the length 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 porous in-growth material that permits embedment therein of endothelial cells of blood flowing through the lumen to thereby reduce thrombus formations along an inner blood contacting surface of the cannula;

a jacket fully encapsulating the liner;

a continuous outer layer bonded to and surrounding the jacket and extending along a full length of the intermediate and distal portions of the liner, the outer layer constructed from a porous in-growth material that permits embedment therein of endothelial cells of blood flowing along an outer blood contacting surface of the cannula to thereby reduce thrombus formations along the outer blood contacting surface;

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

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

42. The inflow cannula of claim 41 further comprising:

a reinforcing structure surrounding at least a part of the intermediate portion of the liner for resisting kinks along the length of the inflow cannula.

43. The inflow cannula of claim 41, wherein the tip includes at least one anchor that extends radially from the tip and is configured to resist a proximally-directed force applied to the inflow cannula.

44. The inflow cannula of claim 43, wherein the tip has an outer surface including a porous in-growth material adjacent to the at least one anchor.

45. The inflow cannula of claim 44 wherein the porous in growth material on the outer surface further includes a prothrombotic coating.

46. The inflow cannula of claim 41, wherein the tip is secured to the inflow cannula by at least one barb, at least one suture, or at least one band.

47. The inflow cannula of claim 41, wherein the inflow cannula extends percutaneously from the heart to the pump.

48. The inflow cannula of claim 41 further comprising:

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

49. An outflow cannula for moving blood from a pump to an arterial structure within the vascular network of a patient, the outflow cannula comprising:

a liner having a length and comprising an intermediate portion that extends for a majority of the length 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 porous in-growth material that permits embedment therein of endothelial cells of blood flowing through the lumen to thereby reduce thrombus formations along an inner blood contacting surface of the cannula;

a jacket fully encapsulating the liner;

a continuous outer layer bonded to and surrounding the jacket and extending along a full length of the intermediate and distal portions of the liner, the outer layer constructed from a porous in-growth material that permits embedment therein of endothelial cells of blood flowing along an outer blood contacting surface of the cannula to thereby reduce thrombus formations along the outer blood contacting surface;

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

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

50. The outflow cannula of claim 49 further comprising:

a reinforcing structure surrounding at least a part of the intermediate portion of the liner for resisting kinks along the length of the outflow cannula.

51. The outflow cannula of claim 49, wherein the distal portion of the liner is also constructed from the porous in-growth material having an outer diameter that is larger than an outer diameter of the porous in-growth material comprising the intermediate portion of the liner.

52. The outflow cannula of claim 49, wherein the distal end includes an anastomotic connector.