Device and method for treatment of mitral insufficiency

• US 7,311,728 B2
• Filed: 09/29/2004
• Issued: 12/25/2007
• Est. Priority Date: 06/29/1999
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Solem, Jan Otto, Kimblad, Per Ola
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/953,047
• Publication Number:
  US 20050043792A1
• Time in Patent Office: 1,182 Days
• Field of Search: 623 236- 237
• US Class Current: 623/2.36
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: Y10S 623/903 Blood vessel

Abstract

A device for treatment of mitral annulus dilatation comprises an elongate body having two states. In a first of these states the elongate body is insertable into the coronary sinus and has a shape adapting to the shape of the coronary sinus. When positioned in the coronary sinus, the elongate body is transferable to the second state assuming a reduced radius of curvature, whereby the radius of curvature of the coronary sinus and the radius of curvature as well as the circumference of the mitral annulus is reduced.

Claims

1. A device for treating tissue near a valve to modify flow through the valve, comprising:

an elongate body having a central region and at least two anchoring regions on opposing end portions of the central region, wherein each anchoring region is configured to be anchored to opposing areas of tissue against or adjacent to an annulus of the valve and urge the areas of tissue towards one another; and

the elongate body being further configured for delivery through a catheter to the tissue whereby the elongate body has a first shape during the delivery and a second shape after the delivery.

2. The device of claim 1 wherein the central region comprises a continuous alternating length.

3. The device of claim 1 wherein each of the anchoring regions comprise a fastener.

4. The device of claim 1 the elongate body being interwoven such that a plurality of spaces are defined therebetween in the second shape.

5. The device of claim 1 further comprising a biocompatible fastener for attaching each of the anchoring regions to the tissue.

6. The device of claim 5 wherein the biocompatible fastener comprises a distal end and a proximal end, the proximal end defining a projection for securing the anchoring region, and the distal end being configured for attachment to the tissue.

7. The device of claim 1 wherein the elongate body is configured to approximate a portion of periphery defined by the valve, the central region comprising an accurate length whereby each of the anchoring regions is in apposition to each other.

8. The device of claim 7 wherein the portion of the periphery approximated by the elongate body comprises at least about 50%.

9. The device of claim 7 wherein each of the anchoring regions is biased towards the central region.

10. The device of claim 1 wherein the elongate body comprises Nickel-Titanium alloy.

11. The device of claim 1 wherein the elongate body is at least partially coated with a coating layer.

12. The device of claim 1 wherein the catheter comprises an elongate tubular member having a distal end and a proximal end with a lumen therebetween, the distal end defining a delivery port configured to pass the elongate body therethrough.

13. The device of claim 12 wherein the catheter further comprises a stylet having a distal end and a proximal end with a length therebetween, the stylet being slidingly disposed in the lumen and being manipulatable from its proximal end.

14. The device of claim 13 wherein the stylet distal end is angled.

15. The device of claim 13 wherein the catheter further comprises a linear advancement mechanism connected to the proximal end of the stylet.

16. A method for treating tissue near a valve to modify flow through the valve, comprising:

providing an elongate body having a central region, a first anchoring region, and a second anchoring region, each of the anchoring regions being attached to opposing end portions of the central region;

placing a delivery catheter near the tissue;

urging the elongate body through a distal opening defined in the catheter such that the first anchoring region exits the distal opening and attaches to a first area of the tissue against or adjacent to an annulus of the valve; and

further urging the elongate body through the distal opening such that the second anchoring region exits the distal opening and attaches to a second area of the tissue against or adjacent to the annulus of the valve such that the first area and the second area are urged towards one another by the elongate body.

17. The method of claim 16 further comprising providing a biocompatible fastener for attaching the first and the second anchoring regions to the first and the second areas of tissue.

18. The method of claim 16 wherein the elongate body is comprised of a shape memory alloy.

19. The method of claim 18 wherein the shape memory alloy comprises Nickel-Titanium alloy.

20. The method of claim 16 wherein the first anchoring region forms a shape configured for attachment to the first area of the tissue upon exiting the distal opening.

21. The method of claim 16 wherein the second anchoring region forms a shape configured for attachment to the second area of the tissue upon exiting the distal opening.

22. The method of claim 16 wherein the first area and the second area are located about 180°

apart.

23. The method of claim 16 wherein urging the elongate body through the distal opening defined in the catheter comprises advancing a stylet having a distal end and a proximal end with a length therebetween through the delivery catheter to urge the elongate body.

24. The method of claim 23 wherein the stylet distal end is angled.

25. The method of claim 23 wherein the stylet is advanced by a linear advancement mechanism connected at the proximal end of the stylet.