Devices, systems, and methods for reshaping a heart valve annulus

• US 20060252984A1
• Filed: 03/27/2006
• Published: 11/09/2006
• Est. Priority Date: 09/20/2000
• 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:
  US11/389,819
• Publication Number:
  US 20060252984A1
• Time in Patent Office: Days
• US Class Current: 600/37
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• 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 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• 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 2017/00619 Locking means for locking the implement in expanded state
• 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 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0451 Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0461 : with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0462 : One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/22044 : with a pointed tip
• CPC Class Codes: A61B 2090/062 : penetration depth
• CPC Class Codes: A61B 2090/0811 : for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61F 2/2451 : Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/30079 : magnetic
• CPC Class Codes: A61F 2210/009 : magnetic

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. A method of placing an implant within a heart chamber comprising

deploying a guide wire in an intravascular path that extends from a first vascular access into a heart chamber and from the heart chamber to a second vascular access site, the guide wire having a first end extending beyond the first vascular access site and a second end extending beyond the second vascular access site,

coupling the implant to one end of the guide wire, and

pulling on the other end of the guide wire to pull the implant along at least a portion of the intravascular path into the heart chamber.

2. A method according to claim 1

wherein the heart chamber comprises a left atrium.

3. A method according to claim 1

further including placing the implant in tension within the heart chamber.

4. A method according to claim 1

wherein the implant 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.

5. A method according to claim 1

wherein the first and second access sites comprise a femoral vein.

6. A method according to claim 1

wherein the first and second access sites are in a groin region.

7. A method according to claim 1

wherein the first and second access sites are in a neck region.

8. A method according to claim 1

wherein one of the first and second access site is in a groin region and the other one of the first and second access sites is in a neck region.

9. A method of implanting a bridge element within a left atrium comprising

deploying a guide wire in an intravascular path that extends from a first vascular access site through an interatrial septum into the left atrium and from the left atrium through a great cardiac vein to a second vascular access site, the guide wire having a first end extending beyond the first vascular access site and a second end extending beyond the second vascular access site,

coupling the bridge element to one end of the guide wire,

pulling on the other end of the guide wire to pull the implant along at least a portion of the intravascular path into the left atrium, and

placing the bridge element in tension between the great cardiac vein and the interatrial septum.

10. A method according to claim 9

wherein the intravascular path extends from the first vascular access site into a right atrium through a vena cava, from the right atrium through the interatrial septum into the left atrium, from the left atrium into and through a great cardiac vein into the right atrium, and from the right atrium through a vena cava to the second vascular access site.

11. A method according to claim 9

wherein the intravascular path extends from the first vascular access site into a right atrium through an IVC, from the right atrium through the interatrial septum into the left atrium, from the left atrium into and through a great cardiac vein into the right atrium, and from the right atrium through a SVC to the second vascular access site.

12. A method according to claim 9

wherein the bridge element is coupled to the second end of the guide wire, and

wherein the first end of the guide wire is pulled to pull the bridge element along at least a portion of the intravascular path through the great cardiac vein and into the left atrium.

13. A method according to claim 9

wherein placing the bridge element in tension includes securing a posterior bridge stop to the bridging element to abut against venous tissue within the great cardiac vein.

14. A method according to claim 9

wherein placing the bridge element in tension includes securing an anterior bridge stop to the bridging element to abut against tissue on the interatrial septum within the right atrium.

15. A method according to claim 14

wherein placing the bridge element in tension includes securing a posterior bridge stop to the bridging element to abut against venous tissue within the great cardiac vein.

16. A method according to claim 9

wherein placing the bridge element in tension includes adjusting tension on the bridge element to achieve a desired therapeutic result.

17. A method according to claim 16

wherein the desired therapeutic result is reducing mitral valve regurgitation.

18. A method according to claim 9

wherein the first and second access sites comprise a femoral vein.

19. A method according to claim 9

wherein the first and second access sites are in a groin region.

20. A method according to claim 9

wherein the first and second access sites are in a neck region.

21. A method according to claim 9

wherein one of the first and second access site is in a groin region and the other one of the first and second access sites is in a neck region.

22. A system comprising

an implant sized and configured for placement within a heart chamber,

a guide wire sized and configured for deployment in an intravascular path that extends from a first vascular access into the heart chamber and from the heart chamber to a second vascular access site, the guide wire having a first end extending beyond the first vascular access site and a second end extending beyond the second vascular access site, and

a connector to connect an end of the implant to one end of the guide wire such that pulling on the other end of the guide wire pulls the implant along at least a portion of the intravascular path into the heart chamber.

23. A system according to claim 22

wherein the implant 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.

24. A system according to claim 22

wherein the first and second access sites comprise a femoral vein.

25. A system according to claim 22

wherein the first and second access sites are in a groin region.

26. A system according to claim 22

wherein the first and second access sites are in a neck region.

27. A system according to claim 22

wherein one of the first and second access site is in a groin region and the other one of the first and second access sites is in a neck region.

28. A system comprising

a bridge element sized and configured to be implanted within the left atrium between the great cardiac vein and the interatrial septum, the bridge element having opposite ends,

a guide wire sized and configured to be deployed in an intravascular path that extends from a first vascular access site through an interatrial septum into the left atrium and from the left atrium through a great cardiac vein to a second vascular access site, the guide wire having a first end extending beyond the first vascular access site and a second end extending beyond the second vascular access site,

a connector to connect an end of the bridge element to one end of the guide wire such that pulling on the other end of the guide wire pulls the bridge element along at least a portion of the intravascular path into the left atrium,

a posterior bridge stop sized and configured to be secured to an end of the bridging element to abut against venous tissue within the great cardiac vein, and

an anterior bridge stop sized and configured to be secured to the bridging element to abut against tissue on the interatrial septum within the right atrium.

29. A system according to claim 28

wherein the guide wire extends along the intravascular path from the first vascular access site into a right atrium through a vena cava, from the right atrium through the interatrial septum into the left atrium, from the left atrium into and through a great cardiac vein into the right atrium, and from the right atrium through a vena cava to the second vascular access.

30. A system according to claim 28

wherein the guide wire extends along the intravascular path from the first vascular access site into a right atrium through an IVC, from the right atrium through the interatrial septum into the left atrium, from the left atrium into and through a great cardiac vein into the right atrium, and from the right atrium through the SVC to the second vascular access site.

31. A system according to claim 28

wherein the bridge element 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.

32. A system according to claim 28

wherein the posterior bridge stop and the anterior bridge stop place the bridge element in tension between the interatrial septum and the great cardiac vein.

33. A system according to claim 28

wherein the first and second access sites comprise a femoral vein.

34. A system according to claim 28

wherein the first and second access sites are in a groin region.

35. A system according to claim 28

wherein the first and second access sites are in a neck region.

36. A system according to claim 28

wherein one of the first and second access site is in a groin region and the other one of the first and second access sites is in a neck region.