Methods of securing a cannula assembly, implanting a circulatory assist system and crossing a tissue barrier

• US 8,333,687 B2
• Filed: 04/18/2011
• Issued: 12/18/2012
• 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, Dusbabek, Andrew J., Hudgins, Robert G., Olson, Scott A.
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US13/088,616
• Publication Number:
  US 20110190567A1
• Time in Patent Office: 610 Days
• Field of Search: 607/122, 607/126, 600/16, 600/18
• 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 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, the cannula assembly including a unitary rigid tip at the distal portion;

deploying a first anchor coupled to the unitary rigid tip from a contracted state to an expanded state;

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

deploying a second anchor coupled to the unitary rigid tip from a contracted state to an expanded state; and

engaging the wall of the heart with the expanded second anchor on a side opposite the expanded first anchor to thereby secure the wall between the first and second anchors;

pumping blood from the heart into the cannula assembly; and

directing the blood into the patient circulatory system.

2. The method of claim 1, wherein the wall of the heart is a septum.

3. The method of claim 1, 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.

4. The method of claim 3, 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.

5. The method of claim 1, wherein deploying the first anchor further comprises moving the cannula assembly relative to a delivery sheath.

6. The method of claim 5, 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.

7. The method of claim 1, wherein deploying the first anchor further comprises deploying a porous polymeric structure on the first anchor constructed to facilitate tissue ingrowth.

8. The method of claim 1, 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.

9. The method of claim 8, 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.

10. The method of claim 1, wherein deploying the second anchor further comprises deploying a porous polymeric structure on the second anchor constructed to facilitate tissue ingrowth.

11. The method of claim 1, wherein the expanded first anchor resists proximal movement of the cannula assembly and the expanded second anchor resists distal movement of the cannula assembly.

12. The method of claim 1, wherein the flexible cannula assembly includes a flexible cannula body and introducing the distal portion of the flexible cannula assembly further comprises:

directing a guide-element through the wall;

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

moving the cannula assembly relative to the delivery sheath so as to deploy the first anchor from the contracted state into the expanded state for engaging the at least one side of the wall.

13. The method of claim 12 further comprising:

retracting the delivery sheath so as to deploy the second anchor from the contracted state to the expanded state for engaging the wall of the heart on a side opposite to the expanded first anchor.

14. The method of claim 12, wherein the guide-element is directed into the left atrium without puncturing the pericardium or myocardial wall.

15. The method of claim 12 further comprising:

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

16. The method of claim 1, wherein pumping the blood and directing the blood respectively further comprise:

pumping the blood through a pump coupled to the cannula assembly; and

directing the blood from the pump through another cannula connected to the circulatory system of the patient.

17. The method of claim 16 further comprising:

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

18. The method of claim 12 further comprising:

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

19. The method of claim 12 further comprising:

dilating an opening in the wall with a balloon catheter.

20. The method of claim 16 further comprising:

operatively connecting a controller to the pump.

21. The method of claim 15 further comprising:

directing the guide-element into the superficial vein to the left atrium through the wall.

22. The method of claim 21, wherein the superficial vein is a peripheral vein.

23. The method of claim 22, wherein the peripheral vein is the subclavian vein, the jugular vein, or a junction between the subclavian vein and the jugular vein.