Decives and methods for heart valve treatment

• US 20060036317A1
• Filed: 07/07/2005
• Published: 02/16/2006
• Est. Priority Date: 11/12/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Myocor, Inc. (Edwards Lifesciences Corporation)
• Inventors: Vidlund, Robert M., Mortier, Todd J., Schweich, Cyril J. Jr., Schroeder, Richard, Ekvall, Craig, Kalgreen, Jason, Matthees, Edward, Kusz, David
• Granted Patent: US 7,666,224 B2
• Time in Patent Office: Days
• US Class Current: 623/2.360
• 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 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/1325 with means for applying local pressure pressure pads A61F5/30
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: Y10S 623/904 Heart

Abstract

Devices and methods for improving the function of a valve (e.g., mitral valve) by positioning a spacing filling device outside and adjacent the heart wall such that the device applies an inward force against the heart wall acting on the valve. A substantially equal and opposite force may be provided by securing the device to the heart wall, and/or a substantially equal and opposite outward force may be applied against anatomical structure outside the heart wall. The inward force is sufficient to change the function of the valve, and may increase coaptation of the leaflets, for example. The space filling device may be implanted by a surgical approach, a transthoracic approach, or a transluminal approach, for example. The space filling portion may be delivered utilizing a delivery catheter navigated via the selected approach, and the space filling portion may be expandable between a smaller delivery configuration and a larger deployed configuration.

Claims

1. A method for improving heart valve function, the method comprising:

providing a device comprising at least one expandable protrusion; and

positioning the expandable protrusion in contact with an external surface of the heart wall such that the protrusion exerts an inward force against the heart wall proximate a valve, wherein the force is sufficient to alter valve function.

2. The method of claim 1, further comprising positioning the device such that the device exerts a force substantially opposite to the inward force as a result of securing the device to the heart wall.

3. The method of claim 1, further comprising positioning the device such that the device exerts a force substantially opposite to the inward force on anatomical structure external to the heart wall.

4. The method of claim 1, wherein the inward force is sufficient to draw leaflets of the valve together.

5. The method of claim 4, wherein the valve leaflets define a line of coaptation and positioning the expandable protrusion includes positioning the expandable protrusion such that the inward force is exerted substantially orthogonal to the line of coaptation.

6. The method of claim 1, wherein the valve is a mitral valve.

7. The method of claim 1, further comprising adjusting a position of the device while observing the valve function.

8. The method of claim 1, wherein the inward force is exerted on an annulus of the valve.

9. The method of claim 1, wherein the inward force is sufficient to reposition papillary muscles of the valve.

10. The method of claim 1, further comprising positioning the device outside the epicardium of the heart.

11. The method of claim 10, further comprising positioning the device between the epicardium and the pericardium of the heart.

12. The method of claim 11, further comprising attaching the device to the epicardium.

13. The method of claim 12, further comprising maintaining the device free of the pericardium.

14. The method of claim 1, further comprising delivering the device to the heart via a surgical approach.

15. The method of claim 1, further comprising delivering the device to the heart via a subthoracic approach.

16. The method of claim 15, wherein the subthoracic approach includes a subxiphoid approach.

17. The method of claim 15, wherein the subthoracic approach includes a posterior approach.

18. The method of claim 1, further comprising delivering the device via a transluminal approach.

19. The method of claim 18, wherein the transluminal approach is via the superior or inferior vena cava, the right atrium, the coronary sinus, and a cardiac vein.

20. The method of claim 18, wherein the transluminal approach is via the superior or inferior vena cava, into the right atrium or right atrial appendage, through the right atrial wall and into the pericardial space.

21. The method of claim 18, wherein the transluminal approach is via the aorta, into the left ventricle, through the left ventricular wall, and into the pericardial space.

22. The method of claim 18, wherein the transluminal approach is via the azygos vein.

23. The method of claim 18, wherein the transluminal approach is via the esophagus.

24. The method of claim 2, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

25. The method of claim 3, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

26. The method of claim 1, wherein the inward force is exerted throughout the cardiac cycle.

27. A method for improving heart valve function, the method comprising:

providing a device having at least one protrusion; and

positioning the device relative to the heart such that the at least one protrusion is in contact with an external surface of a heart wall and exerts an inward force against the heart wall proximate the valve and such that the device exerts a force substantially opposite to the inward force against an anatomical structure outside the heart wall.

28. The method of claim 27, wherein the at least one protrusion exerts an inward force sufficient to alter valve function.

29. The method of claim 27, wherein the inward force is sufficient to draw leaflets of the valve together.

30. The method of claim 29, wherein the valve leaflets define a line of coaptation and positioning the protrusion includes positioning the protrusion such that the inward force is exerted substantially orthogonal to the line of coaptation.

31. The method of claim 27, wherein the valve is a mitral valve.

32. The method of claim 27, further comprising adjusting a position of the device while observing the valve function.

33. The method of claim 27, wherein the inward force is exerted on an annulus of the valve.

34. The method of claim 27, wherein the inward force is sufficient to reposition papillary muscles of the valve.

35. The method of claim 27, further comprising positioning the device outside the epicardium of the heart.

36. The method of claim 35, further comprising positioning the device between the epicardium and the pericardium of the heart.

37. The method of claim 36, further comprising attaching the device to the epicardium.

38. The method of claim 37, further comprising maintaining the device free of the pericardium.

39. The method of claim 27, further comprising delivering the device to the heart via a surgical approach.

40. The method of claim 27, further comprising delivering the device to the heart via a subthoracic approach.

41. The method of claim 40, wherein the subthoracic approach includes a subxiphoid approach.

42. The method of claim 40, wherein the subthoracic approach includes a posterior approach.

43. The method of claim 27, further comprising delivering the device via a transluminal approach.

44. The method of claim 43, wherein the transluminal approach is via the superior or inferior vena cava, the right atrium, the coronary sinus, and a cardiac vein.

45. The method of claim 43, wherein the transluminal approach is via the superior or inferior vena cava, into the right atrium or right atrial appendage, through the right atrial wall and into the pericardial space.

46. The method of claim 43, wherein the transluminal approach is via the aorta, into the left ventricle, through the left ventricular wall, and into the pericardial space.

47. The method of claim 43, wherein the transluminal approach is via the azygos vein.

48. The method of claim 43, wherein the transluminal approach is via the esophagus.

49. The method of claim 27, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

50. The method of claim 27, wherein the inward force is exerted throughout the cardiac cycle.

51-124. -124. (canceled)

125. A system for remodeling a mitral valve annulus, comprising:

a delivery catheter;

an implant, detachably carried by the delivery catheter, the implant reversibly movable between a first, flexible configuration for delivery to a site adjacent the annulus of the mitral valve and a second, rigid configuration for remodeling the mitral valve annulus; and

a control on the catheter for reversibly transforming the implant between the first flexible configuration and the second remodeling configuration.

126. A system as in claim 125, wherein the implant comprises an arc when in the remodeling configuration.

127. A system as in claim 126, wherein the implant comprises a compound curve when in the remodeling configuration.

128. A system as in claim 127, wherein the compound curve comprises a “

w”

configuration.

129. A system as in claim 125, further comprising a coating on the implant.

130. A system as in claim 125, further comprising an anchor for retaining the implant at a deployment site.

131. A system as in claim 130, wherein the anchor comprises a distal extension of the implant.

132. A system as in claim 130, wherein the anchor comprises a friction enhancing surface structure for engaging adjacent tissue.

133. A system as in claim 130, wherein the anchor comprises at least one barb for piercing a wall.

134. A system as in claim 133, wherein the barb is moveable.

135. A method of reducing the circumference of a mitral valve annulus comprising the steps of:

providing a mitral valve reducing device comprising an elongate member;

positioning the elongate member in a first position at a location adjacent the atrioventricular groove and exterior of the vasculature of the heart, wherein in the first position, the elongate member has a first radius of curvature; and

releasing the elongate member in the atrioventricular groove in a second position wherein in the second position the elongate member has a second radius of curvature less than the first radius of curvature so as to reduce the circumference of the mitral valve annulus.

136. The method of claim 135 wherein the step of positioning the elongate member in a first position comprises delivering the elongate member along a coronary sinus to the location adjacent the atrioventricular groove.

137. The method of claim 135 wherein the step of positioning the elongate member in a first position comprises delivering the elongate member through a coronary sinus vessel, forming an opening in the coronary sinus and delivering the elongate member out of the coronary sinus through the opening.

138. The method of claim 135 wherein the step of positioning the elongate member in a first position comprises accessing and navigating the pericardial space.

139. The method of claim 135 wherein the step of releasing the elongate member in the atrioventricular groove in a second position comprises bending the elongate member from the first position into the second position.

140. The method of claim 139 wherein the step of providing an elongate member comprises providing an elongate member having a preferential bending mechanism at a location along a length of the elongate member;

and wherein the step of bending the elongate member comprises bending the elongate member at the location.

141. The method of claim 135 further comprising the step of increasing tissue adherence to the elongate member.

142. The method of claim 141 wherein the step of increasing tissue adherence occurs prior to releasing the elongate member in the atrioventricular groove in the second position.

143. The method of claim 141 wherein the step of increasing the tissue adherence comprises:

providing a coating on the elongate member to cause a tissue response.

144. The method of claim 143 wherein the step of providing a coating comprises providing a coating comprising a tissue growth promoter to cause tissue growth around the elongate member.

145. A system for reducing the mitral annulus of a heart comprising:

a mitral valve reducing device comprising;

an elongate member having a first position wherein in the first position, the elongate member has a first radius of curvature, and a second position wherein in the second position the elongate member has a second radius of curvature less than the first radius of curvature; and

a delivery system comprising;

a catheter configured to access a pericardial space of a heart, adjacent an atrioventricular groove and outside of vasculature of the heart; and

a mitral valve reducing device delivery member configured to place the reducing device in the atrioventricular groove.

146. The system of claim 145 wherein the catheter comprises a puncture wire configured to puncture a vessel in which the catheter resides to access the pericardial space.

147. The system of claim 145 wherein the mitral valve reducing device comprises a preferential bending mechanism at a location along a length of the elongate member.

148. A mitral valve reduction device comprising:

an elongate member having a first position wherein in the first position, the elongate member has a first radius of curvature, a second position wherein in the second position the elongate member has a second radius of curvature less than the first radius of curvature, and a bending mechanism configured to move the elongate member from the first position to the second position; and

the elongate member comprising a tissue response promoter for promoting a tissue response adjacent the elongate member.

149. The mitral valve reduction device of claim 148 wherein the tissue response promoter comprises a tissue growth promoter.

150. A mitral valve reduction device comprising:

an elongate member having a first position wherein in the first position, the elongate member has a first radius of curvature and a second position wherein in the second position the elongate member has a second radius of curvature less than the first radius of curvature; and

an end comprising a tissue engaging element configured to engage the heart within the atrioventricular groove.

151. The mitral valve reduction device of claim 150 wherein the tissue engaging element comprises at least one finger member extending from the end of the elongate member.

152. The mitral valve reduction device of claim 150 further comprising:

a bending mechanism configured to move the elongate member from the first position to the second position.