CANNULA LINED WITH TISSUE IN-GROWTH MATERIAL AND METHOD OF USING THE SAME

• US 20110196191A1
• Filed: 02/11/2011
• Published: 08/11/2011
• Est. Priority Date: 02/11/2010
• Status: Active Grant

• Current Assignee: Circulite Inc. (Medtronic Plc)
• Original Assignee: Circulite Inc. (Medtronic Plc)
• Inventors: Marseille, Oliver, Farnan, Robert C.
• Granted Patent: US 9,504,776 B2
• Time in Patent Office: Days
• US Class Current: 600/16
• 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 fluids 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 for supporting 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; and

a jacket surrounding at least a part of the liner.

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

3. The cannula of claim 1, wherein the tissue 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 tissue in-growth material.

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

13. The cannula of claim 11, wherein the jacket does not surround the tissue in-growth material of the distal portion.

14. 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.

15. 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.

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

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

18. 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.

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

20. The cannula of claim 1 further comprising:

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

21. 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.

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

23. The cannula of claim 21, 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.

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

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

26. The cannula of claim 23, wherein the distally-positioned tip is secured to the cannula by at least one barb, at least one suture, or at least one band.

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

28. 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.

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

30. The cannula of claim 1 further comprising:

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

31. A cannula for moving fluids 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 for supporting 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 for resisting kinks along the length of the cannula; and

a jacket surrounding the reinforcing structure and at least a part of the liner.

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

33. The cannula of claim 31, wherein the proximal and distal portions of the liner are constructed from a polymer material.

34. The cannula of claim 31, wherein the liner is constructed as a unitary structure having the distal, intermediate, and proximal portions constructed from the tissue in-growth material.

35. The cannula of claim 31, wherein the reinforcing structure is constructed from stainless steel, chromium cobalt, a superelastic material, or a rigid polymeric material.

36. The cannula of claim 31, wherein the jacket is constructed from a polymeric material and is bonded to the liner.

37. The cannula of claim 31 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.

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

39. The cannula of claim 37, wherein the distally-positioned tip is secured to the cannula by at least one barb, at least one suture, or at least one band.

40. The cannula of claim 31 further comprising:

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

41. The cannula of claim 31 further comprising:

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

42. The cannula of claim 31 further comprising:

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

43. An inflow cannula for moving fluids 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 for supporting the growth of endothelial cells;

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.

44. The inflow cannula of claim 43 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.

45. The inflow cannula of claim 43 further comprising:

a jacket surrounding the reinforcing structure and at least a part of the liner.

46. The inflow cannula of claim 45 further comprising:

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

47. The inflow cannula of claim 43, 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.

48. The inflow cannula of claim 47, wherein the tip has an outer surface including a tissue in-growth material adjacent to the at least one anchor.

49. The inflow cannula of claim 48 wherein the tissue in-growth material on the outer surface further includes a prothrombotic coating.

50. The inflow cannula of claim 43, wherein the tip is secured to the inflow cannula by at least one barb, at least one suture, or at least one band.

51. The inflow cannula of claim 43, wherein the inflow cannula extends percutaneously from the heart to the pump.

52. The inflow cannula of claim 43 further comprising:

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

53. An outflow cannula for moving fluids 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 for supporting the growth of endothelial cells;

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.

54. The outflow cannula of claim 53 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.

55. The outflow cannula of claim 53 further comprising:

a jacket surrounding the reinforcing structure and at least a part of the liner.

56. The outflow cannula of claim 55 further comprising:

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

57. The outflow cannula of claim 53, wherein the distal portion is also constructed from the tissue in-growth material having an outer diameter that is larger than an outer diameter of the tissue in-growth material comprising the intermediate portion.

58. The outflow cannula of claim 53, wherein the distal end includes an anastomotic connector.

59. A delivery system for percutaneously inserting a cannula into a tissue comprising:

(i) a delivery sheath comprising;

(a) a body having a proximal end, a distal end, and a lumen extending therebetween; and

(b) a balloon-expandable section coupled to the distal end of the body and configured to have first and second states, wherein a diameter of the balloon-expandable section in the first state is smaller than a diameter of the balloon-expandable section in the second state and the diameter of the balloon-expandable section in the second state is configured to receive a cannula and to move relative thereto; and

(ii) a dilator having a body and a distally-positioned inflation member,

wherein the dilator extends through the lumen of the delivery sheath such that the inflation member is positioned within the balloon-expandable section of the delivery sheath, the delivery sheath configured such that inflation of the distally-positioned inflation member expands the balloon-expandable section from the first state to the second state.

60. The delivery system of claim 59, wherein the delivery sheath includes a hub on the proximal end of the body having a hemostasis valve disposed therein.

61. The delivery system of claim 59, wherein the balloon-expandable section is comprised of a balloon-expandable material.

62. A method of percutaneously inserting a cannula into a tissue comprising:

directing a delivery sheath through a puncture in the tissue, wherein the delivery sheath comprises a body having a proximal end, a distal end, and a lumen extending therebetween and a balloon-expandable section coupled to the distal end of the body, wherein the balloon-expandable section is in a first, collapsed state;

inflating an inflation member positioned within the balloon-expandable section such that the balloon-expandable section expands from the first, collapsed state to a second, expanded state and dilates the puncture in the tissue;

deflating and retracting the inflation member from the delivery sheath;

directing a cannula through the lumen of the delivery sheath to the balloon-expandable section; and

retracting the delivery sheath relative to the cannula such that the cannula extends through the dilated puncture in the tissue.

63. A cannula assembly for directing blood from a heart of a patient, comprising:

a flexible cannula body including a proximal portion and a distal portion and a lumen therebetween;

a tip coupled with the distal portion of the flexible cannula body;

an anchor coupled with the tip and configured to be deployed from a contracted state to an expanded state, wherein the anchor is configured to engage at least one side of a heart tissue in the expanded state and is operable to resist movement of the cannula assembly in at least one direction along a lengthwise central axis of the flexible cannula body; and

a tissue in-growth member coupled to an outer surface of the tip adjacent the anchor and configured to facilitate tissue in-growth.

64. The cannula assembly of claim 63 further comprising:

an outer layer surrounding at least a portion of the flexible cannula body, wherein the outer layer is constructed from the tissue in-growth material.