Percutaneous mitral annuloplasty and cardiac reinforcement

• US 6,402,781 B1
• Filed: 01/31/2000
• Issued: 06/11/2002
• Est. Priority Date: 01/31/2000
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Mitralife
• Inventors: Lesh, Michael D., Langberg, Jonathan J.
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Chattopadhyay, Urmi
• Application Number:
  US09/494,233
• Time in Patent Office: 862 Days
• Field of Search: 623/1.1, 623/1-1-, 623/2--
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A mitral annuloplasty and LV restriction device is designed to be transvenously advanced and deployed within the coronary sinus and in some embodiments other coronary veins. The device places tension on adjacent structures, reducing the diameter and/or limiting expansion of the mitral annulus and/or limiting diastolic expansion of the left ventricle. These effects may be beneficial for patients with dilated cardiomyopathy.

Claims

1. A medical apparatus for remodeling a mitral valve annulus adjacent to the coronary sinus, comprising:

an elongate body, having a proximal end region and a distal end region, each of the proximal and distal end regions dimensioned to reside completely within the vascular system, the elongate body being movable from a first configuration for transluminal delivery to at least a portion of the coronary sinus to a second configuration for remodeling the mitral valve annulus proximate the coronary sinus;

a forming element attached to the elongate body for manipulating the elongate body from the first transluminal configuration to the second remodeling configuration; and

a lock for retaining the elongate body in the second configuration at least in part within the coronary sinus.

2. The medical apparatus according to claim 1, wherein the forming element is secured to the elongate body at a point of attachment and the forming element is movable relative to the elongate body in order to adjust the elongate body within the coronary sinus between the first and second configurations.

3. The medical apparatus according to claim 2, wherein the forming element is adapted to be severed while the elongate body is positioned at least in part within the coronary sinus in the second configuration.

4. The medical apparatus according to claim 3, further comprising a cutting tool which is adapted to sever the forming element while the elongate body is positioned at least in part within the coronary sinus.

5. A medical apparatus as in claim 1, wherein the elongate body defines an arc when in the remodeling configuration.

6. A medical apparatus as in claim 5, wherein a best fit constant radius curve corresponding to the arc has a radius within the range of from about 10 mm to about 20 mm.

7. A medical apparatus as in claim 1, wherein the lock comprises a locking ring.

8. A medical apparatus as in claim 1, wherein the lock comprises an interference fit.

9. A medical apparatus as in claim 1, wherein the lock comprises an adhesive bond.

10. A medical apparatus as in claim 1, wherein the lock comprises a suture knot.

11. A medical apparatus as in claim 1, wherein the lock comprises a clamp.

12. A medical apparatus as in claim 1, wherein the lock comprises a compression fit.

13. A medical apparatus as in claim 1, wherein the lock comprises a ratchet.

14. A medical apparatus as in claim 1, wherein the lock comprises an engagement surface, which is movable between a first, disengaged configuration and a second, engaged configuration.

15. A medical apparatus as in claim 1, wherein the lock is biased in a locked direction.

16. A medical apparatus as in claim 1, wherein the lock is biased in an unlocked direction.

17. A medical apparatus as in claim 1, further comprising a coating on the body.

18. A medical apparatus as in claim 1, wherein the apparatus is movable from the implantation configuration to the remodeling configuration in response to proximal retraction of the forming element.

19. A medical apparatus as in claim 1, wherein the apparatus is movable from the implantation configuration to the remodeling configuration in response to distal advancement of the forming element.

20. A medical apparatus as in claim 1, further comprising an anchor for retaining the apparatus at a deployment site within a vessel.

21. A medical apparatus as in claim 20, wherein the anchor comprises a distal extension of the apparatus.

22. A medical apparatus as in claim 20, wherein the anchor comprises a friction enhancing surface structure for engaging the wall of the vessel.

23. A medical apparatus as in claim 20, wherein the anchor comprises at least one barb for piercing the wall of the vessel.

24. A medical apparatus as in claim 1, wherein the apparatus has an axial length of no more than about 10 cm.

25. A medical apparatus as in claim 24, wherein the maximum cross sectional dimension through the apparatus is no more than about 10 mm.

26. A medical apparatus as in claim 1, further comprising an axially extending support in the body, attached to the forming element.

27. A medical apparatus as in claim 1, wherein the forming element comprises a polymeric strand.

28. A medical apparatus as in claim 1, wherein the forming element comprises a metal wire.

29. A medical apparatus as in claim 1, wherein the forming element comprises a multifilament structure.

30. A medical apparatus for remodeling a mitral valve annulus adjacent to the coronary sinus, comprising:

an elongate body, having a proximal end region and a distal end region, each of the proximal and distal end regions dimensioned to reside completely within the vascular system, the elongate body being movable from a first configuration for transluminal delivery to at least a portion of the coronary sinus and a second configuration for remodeling the mitral valve annulus proximate the coronary sinus;

a forming element attached to the elongate body for manipulating the elongate body from the first transluminal configuration to the second remodeling configuration, the forming element secured to the elongate body at a point of attachment and moveable relative to the elongate body in order to adjust the elongate body within the coronary sinus between the first and second configurations, the forming element adapted to be severed while the elongate body is positioned at least in part within the coronary sinus in the second configuration; and

a cutting tool which is adapted to sever the forming element while the elongate body is positioned at least in part within the coronary sinus;

wherein the elongate body maintains a substantially constant length when manipulated by the forming element between the first and second configurations.

31. A medical apparatus for remodeling a mitral valve annulus adacent to the coronary sinus, comprising:

an elongate body, having a proximal end region and a distal end region, each of the proximal and distal end regions dimensioned to reside completely within the vascular system, the elongate body being movable from a first configuration for transluminal delivery to at least a portion of the coronary sinus and a second configuration for remodeling the mitral valve annulus proximate the coronary sinus;

a forming element attached to the elongate body for manipulating the elongate body from the first transluminal configuration to the second remodeling configuration, the forming element secured to the elongate body at a point of attachment and movable relative to the elongate body in order to adjust the elongate body within the coronary sinus between the first and second configurations, the forming element adapted to be severed while the elongate body is positioned at least in part within the coronary sinus in the second configuration; and

a cutting tool adapted to sever the forming element while the elongate body is positioned at least in part within the coronary sinus;

wherein the elongate body is relatively non-compressible while the elongate body is adjusted between the first and second configurations.

32. A medical apparatus for remodeling a mitral valve annulus adjacent to the coronary sinus, comprising:

an elongate body, having a proximal end region and a distal end region, each of the proximal and distal end regions dimensioned to reside completely within the vascular system, the elongate body being movable from a first configuration for transluminal delivery to at least a portion of the coronary sinus and a second configuration for remodeling the mitral valve annulus proximate the coronary sinus;

a forming element attached to the elongate body for manipulating the elongate body from the first transluminal configuration to the second remodeling configuration, the forming element secured to the elongate body at a point of attachment and movable relative to the elongate body in order to adjust the elongate body within the coronary sinus between the first and second configurations, the forming element adapted to be severed while the elongate body is positioned at least in part within the coronary sinus in the second configuration; and

a cutting tool adapted to sever the forming element while the elongate body is positioned at least in part within the coronary sinus;

wherein the elongate body is interchangeably adjustable between the first and second configurations within the coronary sinus.

33. A method of performing transluminal mitral annuloplasty, comprising the steps of:

selecting a prosthesis having a proximal end and a distal end;

providing a deployment system cooperating with the prosthesis and which is adapted to at least in part deliver the prosthesis into the coronary sinus;

inserting the deployment system and prosthesis into the venous system;

transluminally advancing the prosthesis into at least a portion of the coronary sinus;

tightening the prosthesis to generate a compressive force on the adjacent cardiac musculature and influence the size of the mitral valve annulus, the tightening step achieved by proximally retracting a forming element while resisting proximal movement of the prosthesis; and

locking the prosthesis after the step of tightening;

wherein the prosthesis is interchangeably adjustable between tightening to generate the compressive force, and untightening to relieve the compressive force while the prosthesis is positioned within the coronary sinus.

34. A method as in claim 33, further comprising the step of percutaneously accessing the venous system prior to the transluminally advancing step.

35. A method as in claim 33, wherein the accessing step is accomplished by accessing one of the internal jugular, subclavian and femoral veins.

36. A method as in claim 33, further comprising the step of limiting diastolic expansion of the left ventricle.

37. A method as in claim 33, wherein the transluminally advancing step is accomplished using a catheter.

38. A method as in claim 33, wherein the locking step comprises moving an engagement surface from a disengaged configuration to an engaged configuration.

39. A method as in claim 33, wherein the locking step comprises providing an interference fit.

40. A method as in claim 33, wherein the locking step comprises providing an adhesive bond.

41. A method as in claim 33, wherein the locking step comprises providing a knot.

42. A method as in claim 33, wherein the locking step comprises providing a compression fit.

43. A method as in claim 33, further comprising the steps of first measuring the coronary sinus and then selecting an appropriately sized prosthesis prior to the inserting step.

44. A method as in claim 33, further comprising the step of measuring hemodynamic function following the locking step.

45. A method as in claim 44, further comprising the step of determining an ongoing drug therapy taking into account the post implantation hemodynarnic function.

46. A method of performing trasluminaI mitral annuloplasty, comprising the step of:

selecting a prosthesis having a proximal end and a distal end;

providing a deployment system cooperating with the prosthesis and which is adapted to at least in part deliver the prosthesis into the coronary sinus;

inserting the deployment system and prosthesis into the venous system;

transluminally advancing the prosthesis into at least a portion of the coronary sinus;

tightening the prosthesis to generate a compressive force on the adjacent cardiac musculature and influence the size of the mitral valve annulus, the tightening step achieved by proximally retracting a forming element while resisting proximal movement of the prosthesis; and

locking the prosthesis after the step of tightening;

wherein the prosthesis maintains a substantially constant length when tightened to generate the compressive force.