Ventricular cuff

• US 9,199,019 B2
• Filed: 03/15/2013
• Issued: 12/01/2015
• Est. Priority Date: 08/31/2012
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: Thoratec LLC
• Inventors: Callaway, Justin Aron, Pierce, Cori G., Duhamel, Julien, Bourque, Kevin
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Diop, Rokhaya
• Application Number:
  US13/842,578
• Publication Number:
  US 20140067057A1
• Time in Patent Office: 991 Days
• Field of Search: 623/3.1, 623/3.26, 600/16
• US Class Current: 1/1
• 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 60/232 Centrifugal pumps
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
• CPC Class Codes: A61M 60/863 Apex rings

Abstract

In one general aspect, a cuff for attachment to a heart includes an attachment component configured to engage a blood pump to attach the cuff to the blood pump and a sewing ring for attachment to the heart. The sewing ring is coupled to the attachment component, and the attachment component and the sewing ring each define a central opening configured to admit an inflow cannula of a blood pump. The sewing ring comprises a member that provides rigidity to flatten a portion of a myocardium of the heart when the cuff is attached to the heart.

Claims

1. A method comprising:

attaching a cuff to a heart, the cuff comprising a sewing ring having a fabric material internally supported by an insert, and wherein the insert is configured to support the fabric material so as to increase a rigidity of the cuff such that at least a portion of a myocardium of the heart is flattened by the attaching;

forming an opening in the myocardium;

positioning an inflow cannula of a blood pump through a central opening in the cuff and into the opening in the myocardium; and

attaching the blood pump to the cuff;

wherein attaching the cuff to the heart causes at least a portion of the myocardium to flatten, and comprises conforming the myocardium to a shape of the cuff;

wherein a flexural modulus of the sewing ring is greater than 50 psi.

2. The method of claim 1, wherein the cuff comprises two or more layers of fabric.

3. The method of claim 2, wherein the insert is disposed between two or more layers of fabric, the insert being more rigid than the two or more layers of fabric.

4. The method of claim 1, further comprising attaching one or more sutures to one or more suture anchors disposed on an exterior of the blood pump.

5. The method of claim 4, wherein attaching the one or more sutures to one or more suture anchors comprises passing a suture through an eyelet disposed along an outer perimeter of the blood pump and through a portion of the cuff or the myocardium.

6. The method of claim 1, further comprising surrounding the blood pump within an implantable fabric cover defining a pocket around the blood pump.

21. The method of claim 1, wherein the insert comprises a shape memory material.

22. The method of claim 1, wherein the insert comprises a metal material.

23. The method of claim 1, wherein the insert is embedded within a sheet of silicone.

24. The method of claim 23, wherein the insert has openings defining areas where sutures may be placed through the insert and wherein the silicone covers the openings of the insert.

26. The method of claim 1, wherein flattening of the heart expands a space or distance between the inflow cannula and an inner surface of the myocardial wall.

27. The method of claim 1, wherein the flattening of the heart maintains a space or distance between the inflow cannula and an inner surface so as to limit partial or total occlusion of an inlet tip of the inflow cannula.

28. The method of claim 1, wherein the insert increases a rigidity of the cuff along an outer edge of the cuff.

7. A method of attaching a blood pump to a heart, the method comprising:

attaching a cuff to an outer surface of a myocardial wall of the heart;

wherein attaching the cuff to the heart causes at least a portion of the myocardial wall of the heart to flatten in a manner such that a geometry of the myocardial wall contacting a region of the cuff is flatter than a natural geometry of the myocardial wall;

positioning an inflow cannula of the blood pump relative to the cuff; and

coupling the blood pump to the cuff, wherein the flattening limits inflow cannula malposition;

wherein flattening comprises conforming the myocardial wall to a shape of the cuff, the cuff comprising a rigid sewing ring;

wherein a flexural modulus of the sewing ring is greater than 50 psi.

8. The method of claim 7, wherein flattening comprises expanding a space or distance between the inflow cannula and an inner surface of the myocardial wall.

9. The method of claim 7, wherein the flattening maintains a space or distance between the inflow cannula and an inner surface of the myocardial wall so as to limit partial or total occlusion of an inlet tip of the inflow cannula.

10. The method of claim 7, wherein flattening comprises reshaping an inner or outer surface of the myocardial wall along an entire region of the myocardial wall that is in contact with the cuff.

11. The method of claim 7, wherein flattening comprises reshaping the myocardial wall along a proximal side of the blood pump that is coupled to the cuff.

12. The method of claim 7, wherein the cuff comprises a planar sewing ring.

13. The method of claim 12, wherein the flexural modulus of the sewing ring is greater than 50 psi and up to 1500 psi.

14. The method of claim 7, wherein positioning comprises positioning the inflow cannula perpendicular to the cuff so that the cuff extends along a majority of a diameter of the heart pump.

15. The method of claim 7, wherein positioning comprises holding the cuff at the outer edge while the heart pump is subsequently positioned relative to the cuff.

16. The method of claim 15, wherein coupling comprises applying counter-pressure with the cuff against the inflow cannula so as to seat the cuff against the heart pump.

17. The method of claim 16, further comprising engaging a coupling mechanism and locking the cuff to the blood pump.

18. The method of claim 7, further comprising limiting rotation of the blood pump relative to the heart by fastening the blood pump through a portion of the cuff, the outer surface of the heart, or ribs.

19. The method of claim 7, further comprising forming an opening in the myocardial wall and positioning the inflow cannula of the blood pump through a central opening in the cuff and into the opening.

20. The method of claim 7, wherein the myocardial wall comprises a right or left ventricle.

29. The method of claim 7, wherein the flattening comprises using the cuff to flatten the portion of the myocardium, the cuff exerting a resilient force that resists bending of the cuff thereby flattening the myocardium.

30. The method of claim 7, wherein the flattened portion is an area of the myocardium in contact with the cuff.

31. The method of claim 7, further comprising manually reshaping the cuff to a desired configuration, and wherein the reshaped cuff shapes the myocardium to conform to the reshaped cuff.

25. A method comprising:

attaching a cuff to a heart, the cuff comprising a fabric material supported by an insert, and wherein the insert is configured to support the fabric material so as to increase a rigidity of the cuff such that attaching the cuff to the heart causes at least a portion of a myocardium of the heart contacting a region of the cuff to conform to a shape of the cuff;

forming an opening in the myocardium;

positioning an inflow cannula of a blood pump through a central opening in the cuff and into the opening in the myocardium; and

attaching the blood pump to the cuff;

wherein the insert comprises an inner perimeter, an outer perimeter and a plurality of extensions that extend radially between the outer perimeter and the inner perimeter.