Devices, systems, and methods for reshaping a heart valve annulus, including the use of a bridge implant

• US 20050222489A1
• Filed: 03/25/2005
• Published: 10/06/2005
• Est. Priority Date: 10/01/2003
• Status: Abandoned Application

• Current Assignee: MVRx, Inc.
• Original Assignee: Ample Medical, Inc. (MVRx, Inc.)
• Inventors: Machold, Timothy R., Rahdert, David A., Chang, Robert T., Macoviak, John A.
• Application Number:
  US11/089,949
• Publication Number:
  US 20050222489A1
• Time in Patent Office: Days
• US Class Current: 600/37
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0453 threaded elements, e.g. set screws
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61F 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0012 : for adjusting elasticity, flexibility, spring rate or mechanical tension

Abstract

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools.

Claims

1. An implant system comprising

a bridge sized and configured to span a left atrium between a great cardiac vein and an interatrial septum,

a posterior bridge stop that abuts venous tissue within the great cardiac vein, and

an anterior bridge stop that abuts interatrial septum tissue in the right atrium.

2. An implant system according to claim 1

wherein the bridge comprises a metallic material or polymer material or a metallic wire form structure or a polymer wire form structure or suture material or equine pericardium or porcine pericardium or bovine pericardium or preserved mammalian tissue.

3. An implant system according to claim 1

wherein the bridge is sized before implantation.

4. An implant system according to claim 3

wherein the bridge comprises a hollow tube having a first end and a second end, the first end including a first retentive member and the second end including a second retentive member.

5. An implant system according to claim 1

wherein the bridge is sized during implantation.

6. An implant system according to claim 1

wherein at least one of the posterior bridge stop and the anterior bridge stop is symmetrical.

7. An implant system according to claim 1

wherein at least one of the posterior bridge stop and the anterior bridge stop is asymmetrical.

8. An implant system according to claim 1

wherein at least one of the posterior bridge stop and the anterior bridge stop is flexurally preshaped before implantation to conform to the shape of at least one of the tissue within the great cardiac vein and the interatrial septum tissue in the right atrium.

9. An implant system according to claim 1

wherein at least one of the posterior bridge stop and the anterior bridge stop is attached to the bridge prior to implantation.

10. An implant system according to claim 1

wherein at least one of the posterior bridge stop and the anterior bridge stop is attached to the bridge during implantation.

11. An implant system according to claim 1

wherein at least one of the posterior bridge stop and the anterior bridge stop is T-shaped.

12. An implant system according to claim 1

further including a member that mechanically amplifies purchase of at least one of the posterior and anterior bridge stop in abutting tissue.

19. A method of placing an implant as defined in claim 1 within a left atrium of a heart.

20. A method according to claim 19

wherein the bridge is sized before implantation.

21. An implant system according to claim 20

wherein the bridge comprises a hollow tube having a first end and a second end, the first end including a first retentive member and the second end including a second retentive member.

22. A method according to claim 19

wherein the bridge is sized during implantation.

23. A method according to claim 19

wherein at least one of the posterior bridge stop and the anterior bridge stop is attached to the bridge prior to implantation.

24. A method according to claim 19

wherein at least one of the posterior bridge stop and the anterior bridge stop is attached to the bridge during implantation.

13. An implant system comprising

a bridge implant sized and configured to span a left atrium between a great cardiac vein and an interatrial septum,

a first catheter sized and configured to be deployed in the left atrium,

a second catheter sized and configured to be deployed in the great cardiac vein adjacent a posterior mitral valve annulus in a desired alignment with a region of the first catheter in the left atrium, and

a tissue penetrating element sized and configured to be deployed, when the desired alignment exists, between the first and second catheters to create an access site between the left atrium and the great cardiac vein,

the bridge implant being sized and configured to extend between the left atrium and the great cardiac vein through the access site.

14. An implant system according to claim 13

wherein the tissue penetrating element is sized and configured to be deployed from the first catheter from the left atrium into the great cardiac vein.

15. An implant system according to claim 13

wherein the tissue penetrating element is sized and configured to be deployed from the second catheter from the great cardiac vein into the left atrium.

16. An implant system according to claim 13

wherein the first catheter is sized and configured to pass from the right atrium through the interatrial septum into the left atrium.

17. An implant system according to claim 13

wherein the second catheter is sized and configured to pass from the right atrium through a coronary sinus into the great cardiac vein.

18. An implant system according to claim 13

wherein the bridge material comprises a metallic material or polymer material or a metallic wire form structure or a polymer wire form structure or suture material or equine pericardium or porcine pericardium or bovine pericardium or preserved mammalian tissue.

25. A method of placing an implant as defined in claim 13 within a left atrium of a heart.

26. A method of-placing an implant within a left atrium of a heart comprising

providing a length of bridge material having a leading end and a trailing end,

attaching a posterior stop to the leading end,

pushing the posterior stop, attached to the bridge material, through an intravascular path that extends from a vascular access into a right atrium, and from the right atrium through an interatrial septum into a left atrium, and from the left atrium through atrial tissue into a region of a great cardiac vein adjacent a posterior mitral valve annulus,

placing the posterior stop into abutment with venous tissue within the region of the great cardiac vein while retaining the trailing end of the bridge material outside the vascular access,

placing an anterior stop onto the trailing end,

advancing the anterior stop through the vascular access over the bridge material into the right atrium, and

attaching the anterior stop to the bridge material in the right atrium in abutment with interatrial septum tissue, the bridge material within the left atrium comprising a bridge implant that spans the left atrium between the great cardiac vein and the interatrial septum.

27. A method according to claim 26

further including placing the bridge implant within the left atrium in tension by pulling on the trailing end of the bridge material from outside the vascular access, and

wherein attaching the anterior stop holds the tension.

28. A method according to claim 26

further including cutting the length of bridge material near the anterior stop, leaving the bridge implant spanning between the posterior stop and the anterior stop.

29. A method according to claim 26

wherein the intravascular path includes a guide wire.

30. A method according to claim 26

wherein the bridge material comprises a metallic material or polymer material or a metallic wire form structure or a polymer wire form structure or suture material or equine pericardium or porcine pericardium or bovine pericardium or preserved mammalian tissue.

31. A method of placing an implant within a left atrium of a heart comprising

providing a length of bridge material having a leading end and a trailing end,

attaching a posterior stop to the trailing end,

pulling the posterior stop, attached to the bridge material through an intravascular path that extends from a first vascular access through a coronary sinus into a region of a great cardiac vein adjacent a posterior mitral valve annulus, and from the great cardiac vein through atrial tissue into a left atrium, and from the left atrium into a right atrium through an interatrial septum, and from the right atrium to a second vascular access,

placing the posterior stop in abutment with venous tissue within the region of the great cardiac vein while retaining the leading end of the bridge material outside the second vascular access,

placing an anterior stop onto the leading end,

advancing the anterior stop through the second vascular access along the bridge material into the right atrium, and

attaching the anterior stop to the bridge material in the right atrium in abutment with interatrial septum tissue, the bridge material within the left atrium comprising a bridge implant that spans the left atrium between the great cardiac vein and the interatrial septum.

32. A method according to claim 31

further including placing the bridge implant within the left atrium in tension by pulling on the leading end of the bridge material from outside the second vascular access, and

wherein attaching the anterior stop holds the tension.

33. A method according to claim 31

further including cutting the length of bridge material near the anterior stop, leaving the bridge implant spanning between the posterior stop and the anterior stop.

34. A method according to claim 31

wherein the intravascular path includes a guide wire.

35. A method according to claim 31

wherein the bridge material comprises a metallic material or polymer material or a metallic wire form structure or a polymer wire form structure or suture material or equine pericardium or porcine pericardium or bovine pericardium or preserved mammalian tissue.