Methods and devices for heart valve treatments

• US 20040138745A1
• Filed: 10/28/2003
• Published: 07/15/2004
• Est. Priority Date: 10/01/2001
• Status: Active Grant

• Current Assignee: MVRx, Inc.
• Original Assignee: Ample Medical, Inc. (MVRx, Inc.)
• Inventors: Machold, Timothy R., Rahdert, David A., Chang, Robert T., Macoviak, John A., Soss, Rick A.
• Granted Patent: US 7,291,168 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61B 90/50 Supports for surgical instruments, e.g. articulated arms
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• 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: Y10S 623/904 Heart

Abstract

The present invention is a group of medical devices designed to improve heart valve function. The medical devices may be used individually, or in combination to supplement damaged valves, replace damaged valves, or improve damaged valves function. The medical devices include leaflet retainers, a neo-annulus, neo-leaflet, and a framework. In addition, the present invention is novel methods for surgically treating heart valves.

Claims

1. A medical device comprising:

a base member having a shape such that it tracks the circumference of a native heart valve annulus;

and a bridge member extending from the base member over the heart valve orifice, and supported by the base member.

2. The medical device of claim 1, further comprising a spanning material, the spanning material suspended from the bridge member, and adjacent portions of the base member, wherein the spanning material is coupled to the bridge member and adjacent portions of the base member by an attachment means.

3. The medical device of claim 1, wherein the bridge member is manufactured from a super-elastic material.

4. The medical device of claim 1, wherein the base member is sized to change the shape of the native valve annulus when attached to the native valve annulus.

5. The medical device of claim 1, wherein the spanning material is from a group consisting of Nitinol, Dacron fabric, Polytetrafluoroethylene, Silicone, Polyurethane, human pericardium, and animal pericardium.

6. The medical device of claim 1, wherein the attachment means is selected from a group consisting of sewing, gluing, welding, and wrapping the spanning material around itself.

7. The medical device of claim 1, further comprising a framework coupled to the base member and rising from the base member and into the surrounding heart chamber, the reactive forces of the heart on the framework transmitted through the framework and into the annulus retainer.

8. The medical device of claim 7, wherein the framework is shaped to avoid the pulmonary veins.

9. A medical device comprising:

a base member shaped such that it tracks the circumference of a native heart valve annulus,

a set of bridge members extending from the base member over the heart valve orifice, and supported by the base member,

and a spanning material suspended from each bridge member, and adjacent portions of the base member,

wherein the spanning material is coupled to the bridge member and adjacent portions of the base member by an attachment means.

10. The medical device of claim 9, wherein the bridge members are manufactured from a super-elastic material.

11. The medical device of claim 9, wherein the base member is sized to change the shape of the native valve annulus when attached to the native valve annulus.

12. The medical device of claim 9, wherein the spanning material is from a group consisting of Nitinol, Dacron fabric, Polytetrafluoroethylene, Silicone, Polyurethane, human pericardium, and animal pericardium.

13. The medical device of claim 9, wherein the attachment means is selected from a group consisting of sewing, gluing, welding, and wrapping the spanning material around itself

14. The medical device of claim 9, further comprising a framework coupled to the base member and rising from the base member and into the surrounding heart chamber, the reactive forces of the heart on the framework transmitted through the framework and into the annulus retainer.

15. The medical device of claim 14, wherein the framework is shaped to avoid the pulmonary veins.

16. The medical device of claim 9, further including clips, the clips protrude from the base member and press into the ventricular side of the annulus.

17. A medical device comprising:

a semicircular annular ring,

and a spanning material,

wherein the spanning material is coupled to the semicircular annular ring.

18. The medical device of claim 17, wherein the semicircular annular ring is manufactured from a super-elastic material.

19. The medical device of claim 17, wherein the semicircular annular ring is sized to change the shape of the native valve annulus when attached to the native valve annulus.

20. The medical device of claim 17, wherein the spanning material is from a group consisting of Nitinol, Dacron fabric, Polytetrafluoroethylene, Silicone, Polyurethane, human pericardium, and animal pericardium.

21. A medical device comprising:

a circular annular ring,

and a spanning material,

wherein the spanning material is coupled to the circular annular ring such that the spanning material spans a portion of the circular annular ring to function as a coaptation surface for an functioning native leaflet.

22. The medical device of claim 21, wherein the circular annular ring is manufactured from a super-elastic material.

23. The medical device of claim 21, wherein the circular annular ring is sized to change the shape of the native valve annulus when attached to the native valve annulus.

24. The medical device of claim 21, wherein the spanning material is from a group consisting of Nitinol, Dacron fabric, Polytetrafluoroethylene, Silicone, Polyurethane, human pericardium, and animal pericardium.

25. A medical device comprising:

an outer hoop,

an inner hoop,

and struts that radiate between the inner and outer hoops,

wherein the struts are coupled to the outer and inner hoops.

26. The medical device of claim 25, wherein the medical device is manufactured from a super-elastic material.

27. The medical device of claim 25, wherein the medical device is sized to change the shape of the native valve annulus when attached to the native valve annulus.

28. A medical device, comprising:

a wire shaped to encircle the annulus of a heart valve, and radiate along the plane of the annulus both toward and away from the center of the valve orifice in a rhythmic pattern that enables the wire to contact both the valve leaflets and the adjacent heart walls.

29. The medical device of claim 28, wherein the wire is manufactured from a super-elastic material.

30. The medical device of claim 28, wherein the wire may be deployed from an intravascular catheter device.

31. A medical device, comprising:

a wire shaped to encircle the annulus of a heart valve, and radiate along the plane of the annulus both toward and away from the center of the valve orifice in a rhythmic pattern that enables the wire to contact both the valve leaflets and the adjacent heart walls, the wire contacting the head walls forming a anchoring member that provides a holding force to the retainer by embedding into adjacent tissue without damaging it.

32. The medical device of claim 31, wherein the wire is manufactured from a super-elastic material.

33. A medical device, comprising:

a heart chamber framework having two hoops positioned in approximately parallel planes and connected by vertical struts that are coupled to each hoop.

34. The medical device of claim 33, wherein the medical device is manufactured from a super-elastic material.

35. A medical device comprising:

a heart chamber framework having a first hoop and a second hoop, the hoops positioned in parallel planes and connected by vertical struts that are coupled to each hoop,

and a neo-leaflet coupled to the first hoop, positioned to supplement or replace a native leaflet.

36. The medical device of claim 35, wherein the framework is manufactured from a super-elastic material.

37. The medical device of claim 35, further comprising a second neo-leaflet coupled to the interior surface of the first hoop, positioned to supplement or replace a native leaflet.

38. A medical device comprising:

a leaflet retainer, the leaflet retainer formed of a wire that is shaped to extend over a leaflet and restrict the leaflet'"'"'s movements upstream of blood flow,

and a framework, the framework formed of a wire that is shaped to extend into the upstream heart chamber, and to contact the upstream chamber and transmit force from the chamber to the framework and then to the leaflet retainer,

wherein the leaflet retainer and framework are comprised of a continuous wire.

39. The medical device of claim 38, wherein the medical device is manufactured from a super-elastic material.

40. The medical device of claim 38, wherein the device may be deployed from an intravascular catheter device.

41. A medical device comprising:

a tulip-shaped wire form, wherein the tulip-shaped wire form has a framework and leaflet retainer, the leaflet retainer formed of a wire that is shaped to extend over one or more leaflets and restrict the leaflets movements upstream of blood flow,

and a framework, the framework formed of a wire that is shaped to extend into the upstream heart chamber, and to contact the upstream chamber and transmit force from the chamber to the framework and then to the leaflet retainer,

wherein the leaflet retainer and framework are comprised of a continuous wire.

42. The medical device of claim 41, wherein the wire form is manufactured from a super-elastic material.

43. A medical device comprising:

a twisted tulip-shaped wire form, wherein the twisted tulip-shaped wire form has a framework and leaflet retainer, the leaflet retainer formed of a wire that is shaped to extend over one or more leaflets and restrict the leaflets movements upstream of normal blood flow,

and a framework, the framework formed of a wire that is shaped to extend into the upstream heart chamber, and to contact the upstream chamber and transmit force from the chamber to the framework and then to the leaflet retainer,

wherein the leaflet retainer and framework are comprised of a continuous wire.

44. The medical device of claim 43, wherein the wire form is manufactured from a super-elastic material.

45. A medical device comprising:

a mesh-shaped wire form, wherein the mesh-shaped wire form has a framework and leaflet retainer, the leaflet retainer formed of a wire that is shaped to extend over one or more leaflets and restrict the leaflets movements upstream of normal blood flow,

and a framework, the framework formed of a wire that is shaped to extend into the upstream heart chamber, and to contact the upstream chamber and transmit force from the chamber to the framework and then to the leaflet retainer,

wherein the leaflet retainer and framework are comprised of a continuous wire.

46. The medical device of claim 45, wherein the medical device is manufactured from a super-elastic material.

47. A medical device, comprising:

a corona-shaped wire form, wherein the corona-shaped wire form is formed of a single wire that radiates between the valve base and the chamber apex and contacts the adjacent chamber walls.

48. The medical device of claim 47, wherein the medical device is manufactured from a super-elastic material.

49. A method for installing medical devices:

introducing a guidewire into a patient'"'"'s blood vessel;

advancing the guidewire into the heart;

advancing a catheter over the guidewire, the catheter pre-loaded with a medical device comprising;

a base member, the base member having a shape that tracks the circumference of a native heart valve annulus; and

a bridge member, the bridge member extending from the base member over the heart valve orifice, and supported by the base member;

advancing the catheter within the vessel so that the medical device reaches its desired position within the heart;

releasing the medical device into the desired location within the heart;

positioning the medical device within the desired location of the heart;

and withdrawing the catheter from the patient.