TRANSSEPTAL CANNULA, TIP, DELIVERY SYSTEM, AND METHOD

• US 20090112050A1
• Filed: 10/23/2008
• Published: 04/30/2009
• Est. Priority Date: 10/24/2007
• Status: Active Grant

• Current Assignee: Circulite Inc. (Medtronic Plc)
• Original Assignee: Circulite Inc. (Medtronic Plc)
• Inventors: Farnan, Robert C., Jung, Elizabeth, Olson, Scott A., Hudgins, Robert G., Dusbabek, Andrew J.
• Granted Patent: US 8,343,029 B2
• Time in Patent Office: Days
• US Class Current: 600/16
• 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 1/3666 Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
• CPC Class Codes: A61M 1/3667 with assisted venous return
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance

Abstract

A transseptal cannula assembly for directing blood from the heart of a patient and a minimally invasive method of implanting the same. The transseptal cannula assembly includes a flexible cannula body having proximal and distal portions with a lumen therebetween, a tip coupled to the distal portion of the flexible cannula body, and first and second anchors coupled to the tip. The anchors can be configured to be deployed from a contracted state to an expanded state and are configured to engage opposite sides of the heart tissue when in the expanded state. The anchors resist movement of the cannula assembly along a lengthwise central axis of the flexible cannula body.

Claims

1. 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; and

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 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.

2. The cannula assembly of claim 1, wherein the anchor is operable to prevent movement of the cannula assembly in a proximal direction.

3. The cannula assembly of claim 1, wherein the anchor further comprises a plurality of struts extending generally transverse to the lengthwise central axis of the flexible cannula body.

4. The cannula assembly of claim 3, wherein the struts are formed from a superelastic material and are folded to a position generally parallel with the lengthwise central axis when in the contracted state and extend to a position generally transverse to the lengthwise central axis when in the expanded state.

5. The cannula assembly of claim 4, wherein the anchor further includes a porous polymeric structure coupled with the struts and facilitating tissue ingrowth for securing the anchor to the heart tissue.

6. The cannula assembly of claim 1 further comprising:

a second anchor located proximal to the first anchor on the cannula assembly, the second anchor operable to prevent movement of the cannula assembly in a distal direction.

7. The cannula assembly of claim 6, wherein the second anchor further comprises a plurality of struts extending generally transverse to a lengthwise central axis of the flexible cannula body.

8. The cannula assembly of claim 7, wherein the struts are formed from a superelastic material and are folded to a position generally parallel with the lengthwise central axis when in the contracted state and extend to a position generally transverse to the lengthwise central axis when in the expanded state.

9. The cannula assembly of claim 8, wherein the second anchor further includes a porous polymeric structure coupled with the struts and facilitating tissue ingrowth for securing the anchor to the heart tissue.

10. The cannula assembly of claim 6, wherein the second anchor is a hemostasis cuff operable to create a seal between the flexible cannula body and a portion of the body of the patient.

11. The delivery system of claim 10, wherein the portion of the body is a wall of a vein.

12. A delivery system comprising the cannula assembly of claim 1 and a delivery sheath, wherein the delivery sheath is configured to receive the flexible cannula body and move relative thereto for deploying the anchor into the expanded state.

13. The delivery system of claim 12, wherein the cannula assembly and the delivery system are configured to travel to the heart as a unit with the anchor in the contracted state.

14. The delivery system of claim 12 further comprising a guide-element, wherein the guide-element is adapted to be disposed within the cannula assembly and extends both proximally and distally from the cannula assembly.

15. The delivery system of claim 12 further comprising a balloon catheter, wherein the balloon catheter is adapted to expand and engage the delivery sheath to enable the delivery sheath to traverse a septum of the heart.

16. The delivery system of claim 15, wherein the balloon catheter is further adapted to prevent substantial relative movement between the delivery sheath and the cannula assembly.

17. The delivery system of claim 15, wherein the balloon catheter is further adapted to expand and engage only the cannula assembly while the first and second anchors are deployed.

18. The delivery system of claim 17, wherein the balloon catheter includes a lumen having a steerable wire extending therethrough from a distal portion of the balloon catheter to a proximal portion of the balloon catheter and is operable to deflect the distal portion of the balloon catheter.

19. The delivery system of claim 12 further comprising an obturator adapted to enable the delivery sheath to traverse a septum of the heart.

20. The delivery system of claim 12, wherein the delivery sheath includes a proximally located hub.

21. The delivery system of claim 20, wherein the hub is adapted to receive a loading device having a proximal portion and a distal portion and a lumen therebetween and wherein the loading device is adapted to load the cannula assembly into the delivery sheath.

22. The delivery system of claim 21, wherein the delivery sheath includes a hemostasis valve proximal to the hub, the hemostasis valve adapted to control flow of blood through the proximal portion of the delivery sheath.

23. The delivery system of claim 22, wherein the distal portion of the loading device traverses the hub.

24. A method of securing a cannula assembly to a heart of a patient for directing blood from the heart, comprising:

introducing a distal portion of a flexible cannula assembly through a wall of the heart;

deploying a first anchor on the distal portion from a contracted state to an expanded state; and

engaging at least one side of the wall with the expanded first anchor.

25. The method of claim 24, wherein the wall of the heart is a septum.

26. The method of claim 24, wherein deploying the first anchor further comprises deploying a plurality of struts on the anchor extending generally transverse to a lengthwise central axis of the cannula assembly.

27. The method of claim 26, wherein deploying the plurality of struts further comprises moving the struts from a folded state generally parallel with the lengthwise axis to an unfolded state transverse to the lengthwise central axis when in the expanded state.

28. The method of claim 24, wherein deploying the first anchor further comprises moving the cannula assembly relative to a delivery sheath.

29. The method of claim 28, wherein moving the cannula assembly relative to the delivery sheath further comprises:

pushing the cannula assembly in a distal direction to expose the first anchor on the distal portion of the cannula assembly.

30. The method of claim 24, wherein deploying the first anchor further comprises deploying a porous polymeric structure on the first anchor constructed to facilitate tissue ingrowth.

31. The method of claim 24 further comprising:

deploying a second anchor on the distal portion from a contracted state to an expanded state; and

engaging the wall of the heart on a side opposite to the expanded first anchor.

32. The method of claim 31, wherein deploying the second anchor further comprises deploying a plurality of struts on the second anchor extending generally transverse to a lengthwise central axis of the cannula assembly.

33. The method of claim 32, wherein deploying the plurality of struts further comprises moving the struts from a folded state generally parallel with the lengthwise axis to an unfolded state transverse to the lengthwise central axis when in the expanded state.

34. The method of claim 31, wherein deploying the second anchor further comprises deploying a porous polymeric structure on the second anchor constructed to facilitate tissue ingrowth.

35. The method of claim 31, wherein the expanded first anchor resists proximal movement of the cannula assembly and the expanded second anchor resists distal movement of the cannula assembly.

36. A circulatory assist system for assisting the flow of blood through a patient circulatory system, comprising:

a cannula assembly for directing blood from the heart of a patient, the cannula assembly 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, and 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 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;

a pump for drawing blood into the cannula assembly and dispensing the blood from the cannula assembly and into the patient circulatory system; and

a controller operably associated with the pump.

37. The circulatory assist system of claim 36, wherein the pump is implantable.

38. The circulatory assist system of claim 36, wherein the cannula assembly further includes a second anchor located proximal to the first anchor on the cannula assembly, the first anchor operable to resist movement of the cannula assembly in a proximal direction and the second anchor operable to resist movement of the cannula assembly in a distal direction.

39. An anchoring guide-element comprising:

a body portion having a distal end and a proximal end; and

an anchoring portion at the distal end of the body portion, wherein the anchoring portion is configured to be deployed from a contracted state to an expanded state that engages a tissue wall while the body portion extends therefrom, the anchoring portion being substantially transverse to the body portion and operable to resist retraction through the tissue wall.

40. The anchoring guide-element of claim 39, wherein the anchoring portion includes a plurality of struts.

41. The anchoring guide-element of claim 39, wherein the anchoring portion includes a double bend having first and second curved portions, wherein the first and second curved portions are substantially opposed.

42. The anchoring guide-element of claim 39, wherein the anchoring portion includes a loop.

43. A method of implanting a circulatory assist system for assisting in the flow of blood through a patient circulatory system, the circulatory assist system comprising a cannula assembly for directing blood from the heart of a patient, the cannula assembly 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, and first and second anchors coupled with the tip and each being configured to be deployed from a contracted state to an expanded state, wherein the first and second anchors are configured to engage opposite sides of a heart tissue in the expanded state;

the method comprising;

directing a guide-element into a left atrium;

inserting a delivery system including the cannula assembly over the guide-element and into the left atrium, wherein the delivery system includes a delivery sheath configured to receive the flexible cannula body for movement relative thereto;

moving the cannula assembly relative to the delivery sheath so as to deploy the first anchor from the contracted state into the expanded state thereby engaging the heart tissue; and

retracting the delivery sheath so as to deploy the second anchor from the contracted state into the expanded state and thereby engaging the heart tissue.

44. The method of claim 43 further comprising:

directing the guide-element into the left atrium without puncturing the pericardium or myocardial wall.

45. The method of claim 43 further comprising:

creating an incision substantially near a superficial vein and directing the guide-element from the incision to the left atrium through the intra-atrial septum.

46. The method of claim 43 further comprising:

attaching a pump to the cannula assembly, wherein the pump is configured to pump blood into the cannula assembly and direct the blood from the cannula assembly and into the patient circulatory system.

47. The method of claim 46, further comprising:

operatively connecting a controller to the pump.

48. The method of claim 47 further comprising:

implanting the pump subcutaneously or submuscularly at an incision site substantially near a superficial vein.

49. The method of claim 43, wherein the heart tissue is the intra-atrial septum.

50. The method of claim 49 further comprising:

dilating an opening in the septum with an obturator directed over the guide-element.

51. The method of claim 43 further comprising:

dilating an opening in the septum between the left atrium and the right atrium with a balloon catheter.

52. A method of accessing a heart of a patient with an anchoring guide-element, wherein the anchoring guide-element includes an elongate main body having a lengthwise central axis, and an anchoring portion on a distal end, and the method comprising:

creating a first incision substantially near a superficial vein;

inserting the anchoring guide-element through the first incision into the heart, and through a wall of the heart; and

deploying the anchoring portion from a contracted state to an expanded state, wherein the anchoring portion in the expanded state extends substantially transverse to the lengthwise central axis and resists retraction through the wall of the heart.

53. The method of claim 52, wherein the wall of the heart is the septum.

54. The method of claim 52, wherein inserting the anchoring guide-element further comprises directing the anchoring guide-element through the wall of the heart without puncturing the pericardium or myocardial wall.

55. The method of claim 52 further comprising:

creating a second incision substantially superior to the first incision; and

directing a capture device through the second incision to the first incision, the capture device operable to redirect the main body of the anchoring guide-element from the first incision site to the second incision site.

56. A method of accessing a heart of a patient, the method comprising:

inserting an anchoring guide-element through a first incision located substantially near a superficial vein, the anchoring guide-element including an elongate body portion having a lengthwise central axis, and an anchoring portion on a distal end of the body portion;

directing the anchoring guide-element from the first incision into the heart;

deploying the anchoring portion from a contracted state to an expanded state that is substantially transverse to the lengthwise central axis and thereby resisting retraction from the heart;

inserting a capture device through a second incision located substantially near a superficial vein;

capturing the body portion of the anchoring guide-element with the capture device; and

redirecting the body portion of the anchoring guide-element from the first incision to the second incision.

57. The method of claim 56 further comprising:

directing the anchoring guide-element into the heart without puncturing the pericardium or myocardial wall.

58. A delivery system for delivering a cannula assembly having a flexible cannula body, a tip coupled to a distal portion of the flexible cannula body, and an anchor coupled with the tip and configured to be deployed from a contracted state to an expanded state, the delivery system comprising:

a delivery sheath configured to receive the flexible cannula body and move relative thereto to deploy the anchor into the expanded state; and

a balloon catheter having a distal balloon portion operable to maintain a relative position between the delivery sheath and the tip while delivering the cannula assembly.

59. The delivery system of claim 58, wherein the distal balloon portion in a deflated state allows the cannula assembly to move relative to the delivery sheath.

60. A method of crossing a tissue barrier, the method comprising:

creating an opening within the tissue barrier;

directing a balloon catheter to a first side of the tissue barrier at the opening, the balloon catheter including a balloon having a distal-cone portion;

inflating the balloon while on the first side of the tissue barrier;

advancing the balloon catheter to a second side of the tissue barrier through the opening such that the distal-cone portion pierces and dilates the opening; and

continuing to advance the balloon catheter until the balloon catheter extends through the opening and within the tissue barrier.

61. A cannula assembly comprising:

a flexible cannula body having distal and proximal ends with a lumen extending therebetween, the distal end including an attachment portion;

a tip having distal and proximal ends, the proximal end including a receiving portion and removably engaging the attachment portion of the flexible cannula body; and

first and second anchors coupled to the tip and configured to be deployed from a contracted state to an expanded state, the first and second anchors configured to engage opposite sides of a heart tissue.