METHODS OF SECURING A CANNULA ASSEMBLY, IMPLANTING A CIRCULATORY ASSIST SYSTEM AND CROSSING A TISSUE BARRIER

• US 20110190567A1
• Filed: 04/18/2011
• Published: 08/04/2011
• Est. Priority Date: 10/24/2007
• Status: Active Grant

• Current Assignee: Circulite Inc. (Medtronic Plc)
• Original Assignee: Circulite Inc. (Medtronic Plc)
• Inventors: Jung, Elizabeth, Olson, Scott A., Hudgins, Robert G., Dusbabek, Andrew J., Farnan, Robert C.
• Granted Patent: US 8,333,687 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 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.

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 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.

9. The method of claim 8, 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.

10. The method of claim 9, 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.

11. The method of claim 8, wherein deploying the second anchor further comprises deploying a porous polymeric structure on the second anchor constructed to facilitate tissue ingrowth.

12. The method of claim 8, wherein the expanded first anchor resists proximal movement of the cannula assembly and the expanded second anchor resists distal movement of the cannula assembly.

13. 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.

14. The method of claim 13 further comprising:

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

15. The method of claim 13 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.

16. The method of claim 13 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.

17. The method of claim 16, further comprising:

operatively connecting a controller to the pump.

18. The method of claim 17 further comprising:

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

19. The method of claim 13, wherein the heart tissue is the intra-atrial septum.

20. The method of claim 19 further comprising:

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

21. The method of claim 13 further comprising:

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

22. 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.

23. The method of claim 22, wherein the wall of the heart is the septum.

24. The method of claim 22, 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.

25. The method of claim 22 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.

26. 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.

27. The method of claim 26 further comprising:

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

28. 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.