SYSTEM USING A HELICAL RETAINER IN THE DIRECT PLICATION ANNULOPLASTY TREATMENT OF MITRAL VALVE REGURGITATION

• US 20090105816A1
• Filed: 10/10/2008
• Published: 04/23/2009
• Est. Priority Date: 10/19/2007
• Status: Abandoned Application

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Macon, Natalie D., Black, Erin, Cedro, Rudolph, Krever, Matthew, Olsen, Daniel H.
• Application Number:
  US12/249,551
• Publication Number:
  US 20090105816A1
• Time in Patent Office: Days
• US Class Current: 623/2.370
• 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 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61B 2017/2923 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2017/2925 Pistol grips
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/2939 Details of linkages or pivot points
• CPC Class Codes: A61B 2017/2946 Locking means
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

A system for using a helical retainer in the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular tissue each fixed by a retaining clip is described. The system includes four devices to achieve such percutaneous direct plication annuloplasty. The first is a preferably prolapsable crossing catheter. Second, a deflecting guide catheter is used to provide a means for guiding the plication device into proper position at the subvalvular region of the mitral valve annulus. Third, the plication device is then used to make plications in at or near the subvalvular region of the mitral valve annulus. Fourth, a helical retainer clip deployed by the plication device in order to retain the plicated tissue in the plicated form. Alternatively, the fourth device is a retainer delivery catheter that enables delivery of a helical retainer over the outside of the plication device.

Claims

1. A system for the treatment of mitral valve regurgitation through direct plication annuloplasty of a patient comprising:

a deflecting guide catheter having an elongate body with lumen therethrough ending in a distal opening for insertion through the aortic valve into the left ventricle of the patient;

a plication device having a set of opposing jaws operable to plicate tissue in the mitral valve of the patient;

wherein the plication device comprises at least one helical retainer for retaining plications in tissue created by the opposing jaws.

2. The system of claim 1 further comprising a crossing catheter having a distal end for insertion through the aortic valve into the left ventricle of the patient

3. The system of claim 2 further comprising a guidewire for use in guiding the crossing catheter and the deflecting guide catheter through the vasculature of the patient and into the left ventricle.

4. The system of claim 1 wherein the plication device has an elongate tubular body comprised of metal with a pattern cut through the metal.

5. The system of claim 4 wherein the pattern is a dovetail pattern.

6. The system of claim 4 wherein the pattern is a helical pattern.

7. The system of claim 1 wherein a proximal section of the elongate tubular body of the plication device is comprised of nitinol and a distal section of the elongate tubular body is comprised of stainless steel.

8. The system of claim 1 wherein the plication device further includes retainer pusher adapted to releasably engage the proximal end of the helical retainer.

9. The system of claim 8 wherein the plication device further includes a firing knob connected to a firing control wire which rotates upon rotation of the firing knob in a first direction causing the retainer pusher and the helical retainer to rotate into the plicated tissue.

10. The system of claim 9 wherein rotation of the firing knob in a second direction causes the adaptor to be released from the helical retainer.

11. The system of claim 1 wherein the helical retainer comprises at least one barb disposed on said helical retainer for engaging with the plicated tissue.

12. The system of claim 11 wherein the helical retainer is comprised of a wire having a plurality of ridges along its circumference.

13. The system of claim 1 wherein the helical retainer has at least one radiopaque marker disposed thereon.

14. The system of claim 13 wherein the radiopaque marker disposed on the helical retainer is a tantalum microcoil.

15. The system of claim 1 wherein the helical retainer is comprised of stainless steel, MP35N, platinum, nitinol, cobalt chromium or alloys thereof.

16. The system of claim 1 wherein the helical retainer is comprised of a polymeric material.

17. The system of claim 1 wherein the polymeric material is poly lactic acid (PLA) and/or poly glycolic acid (PGA).

18. A system for the treatment of mitral valve regurgitation through direct plication annuloplasty of a patient comprising:

a deflecting guide catheter having an elongate body with lumen therethrough ending in a distal opening for insertion through the aortic valve into the left ventricle of the patient;

a plication device having a set of opposing jaws operable to plicate tissue in the mitral valve of the patient; and

,

a retainer delivery catheter having a proximal end and a distal end and having a helical retainer disposed on the distal end for retaining plications in tissue created by the set of opposing jaws of the plication device.

19. The system of claim 18 further comprising a crossing catheter having distal end for insertion through the aortic valve into the left ventricle of the patient;

20. The system of claim 18 wherein the retainer delivery catheter has an elongate tubular body comprised of metal with a pattern cut through the metal along at least a portion of the elongate tubular body.

21. The system of claim 20 wherein the pattern is a trapezoidal pattern.

22. The system of claim 20 wherein the elongate tubular body of the retainer delivery catheter is comprised of nitinol or stainless steel.

23. The system of claim 18 wherein the retainer delivery catheter further includes an adaptor adapted to releasably engage the proximal end of the helical retainer.

24. The system of claim 23 wherein the adaptor engages the helical retainer when the retainer delivery catheter is rotated in a first direction and releases the helical retainer when rotated in a second direction.

25. The system of claim 18 wherein the helical retainer comprises at least on barb disposed on said helical retainer for engaging with the plicated tissue.

26. The system of claim 18 wherein the helical retainer is comprised of a wire having a plurality of ridges along its circumference.

27. The system of claim 18 wherein the helical retainer has at least one radiopaque marker disposed thereon.

28. The system claim 27 wherein the radiopaque marker disposed on the helical retainer is a tantalum microcoil.

29. The system of claim 18 wherein the helical retainer is comprised of stainless steel, MP35N, platinum, nitinol, cobalt chromium or alloys thereof.

30. The system of claim 18 wherein the helical retainer is comprised of a polymeric material.

31. The system of claim 18 wherein the polymeric material is poly lactic acid (PLA) and/or poly glycolic acid (PGA).