Anchoring system for implantable heart valve prostheses

• US 7,896,913 B2
• Filed: 09/05/2006
• Issued: 03/01/2011
• Est. Priority Date: 02/28/2000
• Status: Expired due to Fees

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Risse, Stefan, Dorrer, Peggy, Mohaupt, Matthias, Lang, Klaus, Weber, Carsten, Harnisch, Gerd, Guyenot, Volker, Damm, Christoph, Figulla, Hans-Reiner, Ferrari, Markus
• Primary Examiner(s): Willse; David H
• Assistant Examiner(s): Blanco; Javier G
• Application Number:
  US11/515,589
• Publication Number:
  US 20070005129A1
• Time in Patent Office: 1,638 Days
• Field of Search: 623/1.14, 623/1.36, 623/2.11, 623/2.14, 623/2.17, 623/2.18, 623/2.23, 623/2.38, 623/2.39, 623/2.4, 623/900
• US Class Current: 623/1.36
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

The invention relates to an anchoring system for heart valve prostheses which can be implanted by introduction via the aorta without any major surgical operation. With the heart valve prosthesis according to the invention it shall be achieved that this can be safely and quickly guided through the aorta toward the heart, and can be fixed there. With this, hook-shaped elements are secured to the commissures of the heart valve prosthesis the hooks of which are guided in an outward direction through the heart valve prosthesis material.

Claims

1. An implantable heart valve prosthesis including a prosthetic valve component and an anchoring system, the anchoring system including a plurality of elongated discrete base elements attached to the prosthetic valve component, each having a longitudinal axis, and a plurality of hook-shaped elements secured to the base elements, wherein each of the plurality of hook-shaped elements includes a distal portion connected to a basal portion, wherein the distal portion of each hook-shaped element transitions from a first position that is inclined with respect to the basal portion approximately 90 degrees in a direction toward the longitudinal axis of a respective base element during implantation of the heart valve prosthesis, to a second position in which the distal portion is substantially aligned with respect to the basal portion when the heart valve prosthesis is deployed at a site of implantation for anchoring in a wall of an aorta, wherein the hook-shaped elements extend through the prosthetic valve component prior to the heart valve prosthesis being positioned at the implantation site and are supported inside the prosthetic valve component by a respective base element.

2. An implantable heart valve prosthesis according to claim 1 wherein the plurality of hook-shaped elements are sewn onto the prosthetic valve component.

3. An implantable heart valve prosthesis according to claim 1 wherein each of the plurality of base elements is secured to and aligned with at least one commissure of the prosthetic valve component.

4. An implantable heart valve prosthesis according to claim 3 wherein the at least one commissure of the prosthetic valve component is one of a plurality of commissures, and each of the plurality of base elements is secured to a different commissure of the prosthetic valve component.

5. An implantable heart valve prosthesis according to claim 1 wherein the longitudinal axis of each of the plurality of base elements is substantially aligned with a longitudinal axis of the prosthetic valve component.

6. An implantable heart valve prosthesis according to claim 1 wherein the plurality of base elements are oriented in a helical orientation.

7. An implantable heart valve prosthesis according to claim 1 wherein the hook-shaped elements are made of a shape memory metal.

8. An implantable heart valve prosthesis according to claim 1 wherein the hook-shaped elements are substantially pin-shaped and are provided with barbs.

9. An implantable heart valve prosthesis according to claim 1 wherein the hook-shaped elements include hook portions, the hook portions being bent into various directions.

10. A medical device, comprising:

a heart valve prosthesis;

a first plurality of pin-shaped elements, each securely connected to a first elongated, discrete base element at a respective first end, the first base element attached to the heart valve prosthesis; and

a second plurality of pin-shaped elements, each securely connected to a second elongated, discrete base element at a respective first end, the second base element attached to the heart valve prosthesis;

wherein each of the first and second plurality of pin-shaped elements includes a distal portion and a basal portion, wherein the distal portion of each pin-shaped element transitions from a first position, inclined substantially 90 degrees with respect to the basal portion in a direction toward a longitudinal axis of a respective base element during implantation of the heart valve prosthesis, to a second position, in which the distal portion is substantially aligned with respect to the basal portion when the heart valve prosthesis is deployed at a site of implantation; and

wherein the pin-shaped elements extend through the heart valve prosthesis prior to the heart valve prosthesis being positioned at the implantation site and are supported inside the heart valve prosthesis by a respective base element.

11. The medical device of claim 10, wherein:

the heart valve prosthesis includes at least two commissures;

the first base element is secured to the heart valve prosthesis through a portion of one of the at least two commissures; and

the second base element is secured to the heart valve prosthesis through a portion of another one of the at least two commissures.

12. The medical device of claim 10, wherein the first and second base elements include respective first and second longitudinal axes and each of the first and second longitudinal axes are substantially aligned with a longitudinal axis of the heart valve prosthesis.

13. The medical device of claim 10, wherein the first and second base elements are substantially helically oriented with respect to a longitudinal axis of the heart valve prosthesis.

14. The medical device of claim 10, wherein each of the first and second plurality of pin-shaped elements is made from a shape memory material and is configured to transition from the first position to the second position when a transition temperature of the shape memory material is exceeded.

15. the medical device of claim 10, wherein each of the first and second plurality of pin-shaped elements includes a barb disposed at a respective distal end.

16. A medical device, comprising:

a heart valve prosthesis;

a first plurality of pin-shaped elements, each connected to a first elongated, discrete base element at a respective first end and having a barb disposed at a respective second end, the first base element attached to the heart valve prosthesis; and

a second plurality of pin-shaped elements, each connected to a second elongated, discrete base element at a respective first end and having a barb disposed at a respective second end, the second base element attached to the heart valve prosthesis;

wherein each of the first and second plurality of pin-shaped elements is made from a shape memory material

wherein each of the first and second pluralities of pin-shaped elements includes a distal portion connected to a basal portion, wherein the distal portion of each pin-shaped element transitions from a first position that is inclined with respect to the basal portion approximately 90 degrees in a direction toward a longitudinal axis of a respective base element during implantation of the heart valve prosthesis, to a second position in which the distal portion is substantially aligned with respect to the basal portion when the heart valve prosthesis is deployed at a site of implantation, wherein the pin-shaped elements extend through the heart valve prosthesis prior to the heart valve prosthesis being positioned at the implantation site and are supported inside the heart valve prosthesis by a respective base element.

17. The medical device of claim 16, wherein the first and second base elements include respective first and second longitudinal axes and each of the first and second longitudinal axes is substantially aligned with a longitudinal axis of the heart valve prosthesis.

18. The medical device of claim 16, wherein the first and second base elements include respective first and second longitudinal axes and each of the first and second longitudinal axes are substantially perpendicular to a longitudinal axis of the heart valve prosthesis.

19. The medical device of claim 16, wherein the first and second base elements are substantially helically oriented with respect to a longitudinal axis of the heart valve prosthesis.