Methods and devices for modulation of heart valve function

• US 8,545,414 B2
• Filed: 04/29/2005
• Issued: 10/01/2013
• Est. Priority Date: 04/30/2004
• Status: Expired due to Fees

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Fitzgerald, Peter J., Hassan, Ali, Courtney, Brian K., Chronos, Nicolas A. F., Cartledge, Richard G., Lee, Leonard Y.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US11/587,765
• Publication Number:
  US 20090234404A1
• Time in Patent Office: 3,077 Days
• Field of Search: 607/119, 607/122, 607/123, 607/62, 607/6, 607/9, 607/11, 607/17, 600/526, 600/374
• US Class Current: 600/526
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36528 the parameter being measured by means of ultrasound
• CPC Class Codes: A61N 1/36571 controlled by blood flow rate, e.g. blood velocity or cardiac output

Abstract

Methods and devices for modulating heart valve function are provided. In the subject methods, a heart valve is first in structurally modified. Blood flow through the structurally modified heart valve is then monitored, and the heart is paced in response to the monitored blood flow. Also provided are devices, systems and kits that find use in practicing the subject methods. The subject methods find use in a variety of applications.

Claims

1. A method of modulating the function of a cardiac valve in a heart and using a cardiac pacing protocol or routine for cardiac pacing, said method comprising:

(a) structurally altering said cardiac valve for modulating a function thereof;

(b) monitoring blood flow velocity by an implanted blood flow velocity measuring device through said structurally altered cardiac valve;

(c) pacing said heart by an implanted cardiac pacing device in response to said monitoring to modulate function of said cardiac valve; and

(d) receiving blood flow velocity information from said implanted blood flow velocity measuring device by an implanted processing element in operational communication with said blood flow velocity measuring device and said cardiac pacing device, said implanted processing element transmitting data relating to a cardiac pacing protocol or routine to said implanted cardiac pacing device by selecting the cardiac pacing protocol or routine based on predetermined blood flow velocity information, wherein said implanted processing element is operative without operator evaluation of the blood flow velocity information to automatically modulate the activity of said implantable cardiac pacing device using the selected cardiac pacing protocol or routine.

2. The method according to claim 1, wherein said modulating results in an improvement in said cardiac valve function.

3. The method according to claim 2, wherein said cardiac valve is a mitral valve.

4. The method according to claim 3, wherein said structurally altering comprises performing an annuloplasty procedure on said mitral valve.

5. The method according to claim 4, wherein said annuloplasty procedure employs an implantable annuloplasty device.

6. The method according to claim 5, wherein said annuloplasty device is an interstitial device.

7. The method according to claim 1, wherein said blood flow velocity measuring device is a sonic device.

8. The method according to claim 1, wherein said blood flow velocity measuring device is an optical device.

9. The method according to claim 1, wherein said blood flow velocity measuring device is a thermal device.

10. The method according to claim 1, wherein said blood flow velocity measuring device is an electromagnetic device.

11. The method according to claim 1, wherein said blood flow velocity measuring device is in operational communication with an implanted cardiac pacing device.

12. The method according to claim 1, wherein said blood flow velocity measuring device is integrated with an implantable annuloplasty device employed in said structural altering step.

13. The method according to claim 12, wherein said blood flow velocity measuring device is an electromagnetic device.

14. The method according to claim 1, wherein said pacing is epicardial pacing.

15. The method according to claim 1, wherein said method is a method of improving function of a mitral valve, wherein said method comprises structurally altering said mitral valve by employing an interstitial annuloplasty device;

wherein said monitoring comprises employing an electromagnetic blood flow velocity measurement element integrated with said interstitial annuloplasty device, wherein said blood flow velocity measuring device is in operational communication with an implanted cardiac pacing device that paces said heart according to step (c).

19. The system according to claim 1, wherein said annuloplasty device is a surgically implanted device.

20. The system according to claim 19, wherein said annuloplasty device is an interstitial device.

16. A system for modulating the function of a cardiac valve in a heart and using a cardiac pacing protocol or routine for cardiac pacing, said system comprising:

(a) an implantable device for structurally altering a cardiac valve for modulating a function thereof;

(b) an implantable blood flow velocity measuring device for monitoring blood flow velocity through a cardiac valve;

(c) an implantable cardiac pacing device in operational communication with said blood flow velocity measuring device;

(d) a storage medium for storing a plurality of cardiac pacing protocols or routines, and

(e) an implantable processing element in operational communication with said blood flow velocity measuring device and said cardiac pacing device, said implantable processing element receiving blood flow velocity information from said blood flow velocity measuring device and transmitting information relating to a cardiac pacing protocol or routine to said cardiac pacing device;

wherein said implantable processing element is operative without operator evaluation of the blood flow velocity information to automatically modulate the activity of said cardiac pacing device based on the cardiac pacing protocol or routing;

wherein the implantable processing element selects at least one of the cardiac pacing protocols or routines from the storage medium based on predetermined blood flow velocity information.

17. The system according to claim 16, wherein said cardiac valve is a mitral valve.

18. The system according to claim 16, wherein said implantable device is an annuloplasty device.

21. The system according to claim 16, wherein said blood flow velocity measuring device is a sonic device.

22. The system according to claim 16, wherein said blood flow velocity measuring device is an optical device.

23. The system according to claim 16, wherein said blood flow velocity measuring device is a thermal device.

24. The system according to claim 16, wherein said blood flow velocity measuring device is an electromagnetic device.

25. The system according to claim 16, wherein said blood flow velocity measuring device is integrated with said implantable device for structurally altering a cardiac valve.

26. The system according to claim 25, wherein said implantable device is an annuloplasty device.

27. The system according to claim 26, wherein said annuloplasty device is a surgically implanted device.

28. The system according to claim 27, wherein said annuloplasty device is an interstitial device.

29. The system according to claim 28, wherein said blood flow velocity measuring device is an electromagnetic device.

30. An implantable system for structurally altering a cardiac valve and providing cardiac pacing protocol or routine information, wherein said implantable system comprises:

an implantable device for structurally altering a cardiac valve for modulating a function thereof;

an integrated blood flow velocity measuring device, said device operational for providing cardiac pacing data in the form of a cardiac pacing protocol or routine to an implantable cardiac pacing device for pacing a heart by electrical stimulation in response to measured blood flow velocity information by said blood flow velocity measuring device;

a storage medium for storing a plurality of cardiac pacing protocol or routines; and

an implantable processing element in operational communication with said blood flow velocity measuring device, said storage medium and said cardiac pacing device, said implantable processing element receiving information from said blood flow velocity measuring device and transmitting to said cardiac pacing device a cardiac pacing protocol or routine based on predetermined blood flow velocity information;

wherein said implantable processing element is operative without operator evaluation of the blood flow velocity information to automatically modulate the activity of said cardiac pacing device by selecting the cardiac pacing protocol or routine based on predetermined blood flow velocity information.

31. The system according to claim 30, wherein said cardiac valve is a mitral valve.

32. The system according to claim 31, wherein said implantable device is an annuloplasty device.

33. The system according to claim 32, wherein said annuloplasty device is a surgically implanted device.

34. The system according to claim 33, wherein said annuloplasty device is an interstitial device.

35. The system according to claim 30, wherein said blood flow velocity measuring device is a sonic device.

36. The system according to claim 30, wherein said blood flow velocity measuring device is an optical device.

37. The system according to claim 30, wherein said blood flow velocity measuring device is a thermal device.

38. The system according to claim 30, wherein said blood flow velocity measuring device is an electromagnetic device.

39. The system according to claim 30, further including a cardiac pacing device in operational communication with said blood flow velocity measurement device.

40. A kit for modulating the function of a cardiac valve in a heart and using a cardiac pacing protocol or routine, said kit comprising:

(a) an implantable device for structurally altering a cardiac valve for modulating a function thereof;

(b) an implantable blood flow velocity measuring device for monitoring blood flow through a cardiac valve;

(c) an implantable cardiac pacing device for providing electrical stimulation to a heart in operative communication with said blood flow velocity measuring device, wherein said electrical pacing stimulation is in the form of a cardiac pacing protocol or routine;

(d) a storage medium for storing a plurality of cardiac pacing protocols or routines; and

(e) an implantable processing element in operational communication with said blood flow velocity measuring device, said storage medium and said cardiac pacing device, said implantable processing element receiving information from said blood flow velocity measuring device and transmitting to said cardiac pacing device a cardiac pacing protocol or routine based on predetermined blood flow velocity information;

wherein said implantable processing element is operative without operator evaluation of the blood flow velocity information to automatically modulate the activity of said cardiac pacing device.

41. The kit according to claim 40, wherein said cardiac valve is a mitral valve.

42. The kit according to claim 41, wherein said implantable device is an annuloplasty device.

43. The kit according to claim 42, wherein said annuloplasty device is a surgically implanted device.

44. The kit according to claim 43, wherein said annuloplasty device is an interstitial device.

45. The kit according to claim 40, wherein said blood flow velocity measuring device is a sonic device.

46. The kit according to claim 40, wherein said blood flow velocity measuring device is an optical device.

47. The kit according to claim 40, wherein said blood flow velocity measuring device is a thermal device.

48. The kit according to claim 40, wherein said blood flow velocity measuring device is an electromagnetic device.

49. The kit according to claim 40, wherein said blood flow velocity measuring device is integrated with said implantable device for structurally altering a cardiac valve.

50. The kit according to claim 49, wherein said implantable device is an annuloplasty device.

51. The kit according to claim 50, wherein said annuloplasty device is a surgically implanted device.

52. The kit according to claim 51, wherein said annuloplasty device is an interstitial device.

53. The kit according to claim 50, wherein said blood flow velocity measuring device is an electromagnetic device.

54. The kit according to claim 40, wherein said cardiac pacing device is an epicardial pacing device.

55. The kit according to claim 40, wherein said kit further comprises instructions for using said kit.