Claims
- 1. A device for treating mitral valve regurgitation, comprising:
a tether; a distal anchoring member positioned adjacent to a distal end of the tether; and a proximal anchoring member positioned adjacent to a proximal end of the tether; wherein at least one of the anchoring members includes an elastic portion that flexes in response to a heart beat when the tensioning device is positioned across a chamber of a heart.
- 2. The device of claim 1 wherein the elastic portion comprises a material selected from a group consisting of a nickel-titanium alloy, a nickel- cobalt alloy, a cobalt alloy, a thermoset plastic, stainless steel, a biocompatible shape-memory material, a biocompatible superelastic material, and a combination thereof.
- 3. The device of claim 1 wherein the elastic portion comprises a plurality of flexible arm segments.
- 4. The device of claim 3 wherein the flexible arm segments are in a radially compressed, folded configuration while the anchoring member is within a lumen of a delivery catheter, and wherein the flexible arm segments self-expand when the anchoring member is released from the delivery catheter.
- 5. The device of claim 4 wherein the flexible arm segments of at least one of the anchoring members self-expand between the surfaces of a wall of a chamber of a heart.
- 6. The device of claim 1 wherein the tether comprises a material selected from a group consisting of stainless steel, titanium, a nickel-titanium alloy, a nickel-cobalt alloy, a cobalt alloy, tantalum, polypropylene, polyethylene, polyurethane, polytetrafluoroethylene (PTFE), polyester (Dacron®), nylon, a flexible and strong biocompatible material, and a combination thereof.
- 7. The device of claim 1 wherein at least a portion of the tether has a helical configuration.
- 8. The device of claim 1 wherein the tether includes a release loop adjacent to a proximal end of the tether.
- 9. The device of claim 1 further comprising:
at least one locking member affixed to the tether, wherein when the at least one locking member is pulled from an initial position between the proximal and distal anchors to a locked position proximal the proximal anchor, the length of the tether is adjusted to change the proximity of the anchoring members one to the other.
- 10. The device of claim 1 further comprising:
at least one sealing member.
- 11. The device of claim 1 wherein at least a portion of the tensioning device includes a therapeutic agent selected from a group consisting of an antithrombotic, an anticoagulant, an antibiotic, an anti-inflammatory, and a combination thereof.
- 12. A system for treating mitral valve regurgitation including the tensioning device of claim 1 and further comprising:
a delivery catheter, wherein the tensioning device is slidably received within a lumen of the delivery catheter.
- 13. The system of claim 12 wherein the delivery catheter comprises a guiding sheath, a piercing tube slidably received within a lumen of the guiding sheath, a holding tube slidably received within a lumen of the piercing tube, and a push cylinder slidably received within a lumen of the holding tube.
- 14. The system of claim 13 wherein the delivery catheter further comprises a stop collar attached to an outside surface of a distal portion of the piercing tube, and wherein a portion of the stop collar is self-expanding when the stop collar is positioned outside the lumen of the guiding sheath.
- 15. A system for treating mitral valve regurgitation, comprising:
a delivery catheter; and a tensioning device received in the delivery catheter, the tensioning device including a tether, a distal anchoring member positioned adjacent to a distal end of the tether, a proximal anchoring member positioned adjacent to a proximal end of the tether, and at least one locking member affixed to the tether; wherein when the locking member is pulled from an initial position between the anchors to a locked position proximal the proximal anchoring member, the length of the tether is adjusted to change the proximity of the anchoring members one to the other.
- 16. The system of claim 15 wherein the tether includes a release loop adjacent to a proximal end of the tether.
- 17. The system of claim 15 wherein the locking member comprises a generally cylindrical member having a flexible tab flaring out from the cylindrical member.
- 18. The system of claim 15 wherein the locking member comprises a generally cylindrical member having an end shaped to form an angle with the longitudinal axis of the cylindrical member that is less than 90 degrees.
- 19. The system of claim 15 wherein at least one of the anchoring members includes an elastic portion that flexes in response to a heart beat when the tensioning device is positioned across a chamber of a heart.
- 20. The system of claim 19 wherein the elastic portion of the at least one anchoring member comprises a material selected from a group consisting of a nickel-titanium alloy, a nickel-cobalt alloy, a cobalt alloy, a thermoset plastic, stainless steel, a biocompatible shape-memory material, a biocompatible superelastic material, and a combination thereof.
- 21. The system of claim 19 wherein the elastic portion comprises a plurality of flexible arm segments.
- 22. The system of claim 21 wherein the flexible arm segments are in a radially compressed, folded configuration while the anchoring member is within a lumen of the delivery catheter and wherein the flexible arm segments self-expand when the anchoring member is released from the delivery catheter.
- 23. The system of claim 21 wherein the flexible arm segments of at least one of the anchoring members self-expand between the surfaces of a wall of a chamber of a heart.
- 24. The system of claim 15 wherein the tether comprises a material selected from a group consisting of stainless steel, titanium, a nickel-titanium alloy, a nickel-cobalt alloy, a cobalt alloy, tantalum, polypropylene, polyethylene, polyurethane, polytetrafluoroethylene (PTFE), polyester (Dacron®)), nylon, a flexible and strong biocompatible material, and a combination thereof.
- 25. The system of claim 15 wherein at least a portion of the tensioning device includes a therapeutic agent selected from a group consisting of an antithrombotic, an anticoagulant, and a combination thereof.
- 26. The system of claim 15 wherein the tensioning device includes at least one sealing member.
- 27. The system of claim 15 wherein the delivery catheter comprises a guiding sheath, a piercing tube slidably received within a lumen of the guiding sheath, a holding tube slidably received within a lumen of the piercing tube, and a push cylinder slidably received within a lumen of the holding tube.
- 28. The system of claim 27 wherein the delivery catheter further comprises a stop collar attached to an outside surface of a distal portion of the piercing tube, and wherein a portion of the stop collar is self-expanding when the stop collar is positioned outside the lumen of the guiding sheath.
- 29. A method of treating mitral valve regurgitation by affecting a mitral valve annulus, comprising:
piercing a first wall of a chamber of a heart; engaging a distal anchoring member with a second wall of the heart chamber; engaging a proximal anchoring member with the first wall of the heart chamber; and pulling at least one locking member affixed to a tether linking the proximal and distal anchoring members from an initial position between the two anchoring members to a locked position proximal the proximal anchoring member.
- 30. The method of claim 30 further comprising:
prior to piercing the first wall of the heart chamber, delivering a system for treating mitral valve regurgitation to a position adjacent to the first wall, the system including means for piercing the first wall, proximal and distal anchoring members, and at least one locking member affixed to a tether linking the proximal and distal anchoring members.
- 31. The method of claim 29 wherein the first wall is the septal wall between the right and left ventricles of the heart.
- 32. The method of claim 31 wherein the second wall is a free wall of the left ventricle of the heart.
- 33. The method of claim 30 wherein at least one of the anchoring members flexes in response to a heart beat when the anchoring members and tether are positioned across a chamber of a heart.
PRIORITY CLAIM
[0001] This application claims the benefit of U.S. Provisional Application No. 60/480,195 filed Jun. 20, 2003; U.S. Provisional Application No. 60/480,472 filed Jun. 20, 2003; and U.S. Provisional Application No. 60/503,035 filed Sep. 15, 2003; the entirety of each of which is hereby incorporated by reference.
Provisional Applications (3)
|
Number |
Date |
Country |
|
60480195 |
Jun 2003 |
US |
|
60480472 |
Jun 2003 |
US |
|
60503035 |
Sep 2003 |
US |