Ventricular cuff

• US 9,981,076 B2
• Filed: 03/06/2015
• Issued: 05/29/2018
• Est. Priority Date: 03/02/2012
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Inventors: Callaway, Justin Aron, Pierce, Cori G., Duhamel, Julien, Bourque, Kevin, Hill, J. Donald, Barnes, Terry, West, Dustin Seth, Gazzara, III, Peter
• Primary Examiner(s): Prone, Christopher D
• Assistant Examiner(s): Diop, Rokhaya
• Application Number:
  US14/641,164
• Publication Number:
  US 20150273124A1
• Time in Patent Office: 1,180 Days
• 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 60/857 Implantable blood tubes
• 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 ventricular cuff for coupling to a heart of a patient in an attachment direction and facilitating engagement of a heart pump to the heart, the ventricular cuff comprising:

an apical ring defining an opening for receiving an inlet cannula of the heart pump, the apical ring having a heart pump engaging perimeter and a sewing ring engaging perimeter opposite the heart pump engaging perimeter;

a sewing ring coupled with the sewing ring engaging perimeter of the apical ring, the sewing ring including a heart tissue engaging surface and a top surface opposite the heart tissue engaging surface; and

a rigid frame backing the sewing ring along the top surface of the sewing ring, the rigid frame comprising a plurality of struts extending outwardly from the opening defined by the apical ring and toward an outer perimeter of the sewing ring;

wherein the plurality of struts of the rigid frame are configured to maintain a space between the top surface of the sewing ring and the heart pump engaging perimeter of the apical ring during implantation of the ventricular cuff and the heart pump to the heart of the patient;

wherein the plurality of struts extend outwardly and in the attachment direction towards the heart from the opening defined by the apical ring; and

wherein a top surface of the rigid frame defines a convex surface and a sewing ring engaging surface opposite the top surface of the rigid frame defines a concave surface.

2. The ventricular cuff of claim 1, wherein the top surface of the rigid frame defines a frustoconical shape.

3. The ventricular cuff of claim 1, wherein the rigid frame comprises an outer ring and wherein peripheral ends of the plurality of struts are coupled with the outer ring.

4. The ventricular cuff of claim 3, wherein the rigid frame comprises an inner ring, wherein the plurality of struts extend from the inner ring toward the outer ring, and wherein the plurality of struts are visible to a physician during implantation.

5. The ventricular cuff of claim 3, wherein the outer ring has a diameter less than a diameter of the sewing ring.

6. The ventricular cuff of claim 5, wherein the outer ring diameter is at least 2 mm less than the sewing ring diameter.

7. The ventricular cuff of claim 6, wherein the outer ring diameter is at least 4 mm less than the sewing ring diameter.

8. The ventricular cuff of claim 1, further comprising an insert ring coupling the sewing ring to the apical ring.

9. The ventricular cuff of claim 8, wherein the insert ring defines an opening for receiving and engaging with the apical ring, an outer surface of the apical ring configured to engage with an inner surface of the insert ring in a friction fit engagement.

10. The ventricular cuff of claim 9, wherein the rigid frame is configured to be clamped between a central lip of the apical ring and the insert ring during engagement of the apical cuff and the insert ring to secure the rigid frame against the sewing ring, wherein the central lip extends from the outer surface of the apical ring.

11. The ventricular cuff of claim 10, wherein the apical ring includes an alignment feature for engaging with a corresponding alignment feature of the rigid frame, wherein engagement of the alignment feature of the apical ring with the corresponding alignment feature of the rigid frame aligns the rigid frame about the opening defined by the apical ring.

12. The ventricular cuff of claim 8, wherein the insert ring comprises a metal material, wherein the sewing ring comprises a fabric material, and wherein the insert ring and sewing ring are coupled together to provide a fluid tight seal between the insert ring and the sewing ring.

13. The ventricular cuff of claim 12, wherein the insert ring includes a lip that overlaps with the heart tissue engaging surface of the sewing ring, the lip having a plurality of holes therethrough, wherein the insert ring and sewing ring are coupled together at the overlap by an elastomer, wherein the elastomer impregnates the fabric material of the sewing ring and forms mechanical links through the holes in the lip of the insert ring.

14. The ventricular cuff of claim 13, wherein an adhesion of the elastomer to the metal material of the insert ring is increased by application of an adhesion promoter to the metal of the insert ring.

15. The ventricular cuff of claim 1, wherein the rigid frame is configured for urging the top surface of the sewing ring to a convex configuration.

16. The ventricular cuff of claim 1, wherein the rigid frame is configured to maintain the sewing ring in a frustoconical configuration.

17. The ventricular cuff of claim 1, wherein the rigid frame is configured for urging the heart tissue engaging surface of the sewing ring to a concave configuration.

18. A ventricular cuff for coupling with a heart of a patient in an attachment direction, the ventricular cuff comprising:

an insert ring comprising metal material having a cylindrical portion defining a central opening;

a single sewing ring comprising a felt material disposed about the insert ring, the sewing ring including a heart tissue engaging surface and a top surface opposite the heart tissue engaging surface;

an elastomer coupling the sewing ring to the insert ring at an interface between the insert ring and the sewing ring and forming a fluid tight engagement between the sewing ring and the insert ring; and

a rigid frame secured to the insert ring and including a plurality of struts extending outwardly from the central opening, the rigid frame secured to the insert ring such that the plurality of struts of the rigid frame are urged against the sewing ring and extend toward an outer perimeter of the sewing ring, the plurality of struts supporting the sewing ring so as to resist deformation of the sewing ring in the attachment direction during attachment of the ventricular cuff to a heart of a patient, wherein;

the plurality of struts extend outwardly and in the attachment direction towards the heart from the opening defined by the apical ring; and

a top surface of the rigid frame defines a convex surface and a sewing ring engaging surface opposite the top surface of the rigid frame defines a concave surface.

19. The ventricular cuff of claim 18, wherein the insert ring includes a lip extending outwardly of the central opening of the insert ring from an end of the cylindrical portion, the lip including a plurality of holes therethrough;

and wherein the lip of the insert ring overlaps with sewing ring so as to form the interface between the insert ring and the sewing ring.

20. The ventricular cuff of claim 19, wherein the elastomer impregnates the felt material of the sewing ring so as to form a mechanical engagement with the sewing ring and forms mechanical links through the holes of the lip of the insert ring so as to form a mechanical engagement with the insert ring.

21. The ventricular cuff of claim 20, wherein the elastomer chemically adheres to the insert ring through an adhesion promoter.

22. The ventricular cuff of claim 18, wherein the plurality of struts of the rigid frame are visible to a surgeon during attachment of the cuff to the heart.

23. The ventricular cuff of claim 18, wherein the plurality of struts extend in the attachment direction at least 0.05 inches as the plurality of struts extend outwardly.

24. The ventricular cuff of claim 18, wherein the rigid frame urges the sewing ring into a domed configuration where the top surface of the sewing ring is convex and the heart tissue engaging surface of the sewing ring is concave.

25. The ventricular cuff of claim 24, wherein the rigid frame includes an outer ring, and wherein the plurality of struts of the rigid frame extend outwardly and couple to the outer ring to support the outer ring against the perimeter of the sewing ring.

26. The ventricular cuff of claim 18, further comprising an apical ring, the apical ring including a heart pump engaging end and a sewing ring engaging end, and wherein the sewing ring engaging end is configured to engage with the insert ring.

27. The ventricular cuff of claim 26, wherein the sewing ring engaging end of the apical ring engages with the insert ring in a press-fit engagement.

28. The ventricular cuff of claim 26, wherein the apical ring includes an alignment feature for engaging a corresponding alignment feature on the rigid frame so as to align the apical ring with the rigid frame.

29. The ventricular cuff of claim 26, wherein the rigid frame is urged against the sewing ring by the engagement of the apical ring to the insert ring.