Adjustable annuloplasty ring with subcutaneous activation port

• US 8,821,570 B2
• Filed: 07/20/2010
• Issued: 09/02/2014
• Est. Priority Date: 07/20/2009
• Status: Expired due to Fees

• Current Assignee: MiCardia Corporation
• Original Assignee: MiCardia Corporation
• Inventors: DuMontelle, Jeffrey P., Buchbinder, Maurice, Shaolian, Samuel M., Dang, Ninh H., Molloy, Paul A., Tsukashima, Ross, Gray, Brian C., Anderson, Daniel C.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): WOLF, MEGAN YARNALL
• Application Number:
  US13/386,331
• Publication Number:
  US 20120197392A1
• Time in Patent Office: 1,505 Days
• Field of Search: 623/2.37
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 2210/0033 electrically, e.g. heated by resistor
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062

Abstract

Annuloplasty rings are employed to treat heart valve defects, such as regurgitation. Synching the heart tissue to the ring restores the valve opening to its approximate original size and operating efficiency. Adjustable annuloplasty rings allow for a proper degree of synching both during open heart surgery and over the patient'"'"'s lifetime. A subcutaneous port may be coupled to an adjustable annuloplasty ring such that an external activation energy generator can be used to heat the adjustable annuloplasty ring and thereby adjust the size of the annuloplasty ring.

Claims

1. An annuloplasty ring assembly, comprising:

an adjustable annuloplasty ring including a body member comprising shape memory material to change a dimension of the adjustable annuloplasty ring in response to application of an activation energy;

a subcutaneous activation cable to provide the activation energy to the shape memory material of the adjustable annuloplasty ring, the subcutaneous activation cable comprising;

a first end coupled to the adjustable annuloplasty ring; and

a second end comprising a subcutaneous connector including a first plurality of electrodes,

wherein the subcutaneous connector comprises an in-line connector such that the first plurality of electrodes comprise electrically conductive bands arranged along an axis of the subcutaneous activation cable to form a male connector; and

a subcutaneous port implantable in subcutaneous tissue within a patient, the subcutaneous port comprising;

a first interface to receive the subcutaneous connector of the subcutaneous activation cable;

a second interface to receive a transcutaneous connector inserted through the patient'"'"'s skin, the transcutaneous connector providing the activation energy to the subcutaneous port through a second plurality of electrodes; and

a plurality of electrical interconnections to establish electrical communication between the first plurality of electrodes of the subcutaneous connector and respective ones of the second plurality of electrodes of the transcutaneous connector,

wherein the first interface of the subcutaneous port comprises a first aperture providing access to a first channel within the subcutaneous port to form a female connector that receives the male in-line connector of the subcutaneous connector and establishes an electrical connection between the first plurality of electrodes and respective ones of the plurality of electrical interconnections of the subcutaneous port,

wherein the second interface of the subcutaneous port comprises a second aperture providing access to a second channel within the subcutaneous port to form a female connector that receives a male in-line connector of the transcutaneous connector and establishes an electrical connection between the second plurality of electrodes and respective ones of the plurality of electrical interconnections of the subcutaneous port,

wherein the first aperture of the first interface and the second aperture of the second interface are located on opposing sides of the subcutaneous port, and

wherein an axis of the first channel is in a first plane, an axis of the second channel is in a second plane, and the first plane is parallel to the second plane.

2. The annuloplasty ring assembly of claim 1, wherein the subcutaneous port comprises a plurality of suture apertures that are each configured to receive a suture to attach the subcutaneous port to the subcutaneous tissue.

3. The annuloplasty ring assembly of claim 2, wherein the suture apertures are located on a flange of the port, and wherein the flange extends away from the port.

4. The annuloplasty ring assembly of claim 1, wherein the adjustable annuloplasty ring further comprises a heating element coiled around at least a portion of the body member comprising the shape memory material, wherein the activation energy comprises radio frequency (RF) energy, and wherein the heating element generates thermal energy in response to receiving the RF energy through the subcutaneous activation cable.

5. The annuloplasty ring assembly of claim 4, wherein the heating element comprises a variable density coil that transfers thermal energy to the body member at a higher rate in areas corresponding to relatively higher coil densities.

6. The annuloplasty ring assembly of claim 1, wherein the subcutaneous activation cable comprises a coaxial cable comprising an inner coil and an outer coil separated from one another by an insulator.

7. The annuloplasty ring assembly of claim 1, wherein the first end of the subcutaneous activation cable is coupled to the adjustable annuloplasty ring at a location corresponding to a P2/P3 leaflet junction of a mitral valve when the adjustable annuloplasty ring is implanted around the annulus of the mitral valve.

8. The annuloplasty ring assembly of claim 1, wherein the first end of the subcutaneous activation cable is coupled to the adjustable annuloplasty ring at a location corresponding to a P1/P2 leaflet junction of a mitral valve when the adjustable annuloplasty ring is implanted around the annulus of the mitral valve.

9. The annuloplasty ring assembly of claim 1, further comprising a thermocouple to measure a temperature within the adjustable annuloplasty ring, the subcutaneous activation cable further comprising one or more leads for communicating signals between the thermocouple and the subcutaneous port.

10. The annuloplasty ring assembly of claim 1, further comprising a resistive element with a resistive value selected to uniquely identify at least one of the adjustable annuloplasty ring and the subcutaneous activation cable.

11. An annuloplasty ring assembly, comprising:

an adjustable annuloplasty ring including a body member comprising shape memory material to change a dimension of the adjustable annuloplasty ring in response to application of an activation energy;

a subcutaneous activation cable to provide the activation energy to the shape memory material of the adjustable annuloplasty ring, the subcutaneous activation cable comprising;

a first end coupled to the adjustable annuloplasty ring; and

a second end comprising a subcutaneous connector including a first plurality of electrodes,

wherein the subcutaneous connector comprises an in-line connector such that the first plurality of electrodes comprise electrically conductive bands arranged along an axis of the subcutaneous activation cable to form a male connector; and

a subcutaneous port implantable in subcutaneous tissue within a patient, the subcutaneous port comprising;

a first interface to receive the subcutaneous connector of the subcutaneous activation cable;

a second interface to receive a transcutaneous connector inserted through the patient'"'"'s skin, the transcutaneous connector providing the activation energy to the subcutaneous port through a second plurality of electrodes; and

a plurality of electrical interconnections to establish electrical communication between the first plurality of electrodes of the subcutaneous connector and respective ones of the second plurality of electrodes of the transcutaneous connector,

wherein the first interface of the subcutaneous port comprises a first aperture providing access to a first channel within the subcutaneous port to form a female connector that receives the male in-line connector of the subcutaneous connector and establishes an electrical connection between the first plurality of electrodes and respective ones of the plurality of electrical interconnections of the subcutaneous port,

wherein the second interface of the subcutaneous port comprises a second aperture providing access to a second channel within the subcutaneous port to form a female connector that receives a male in-line connector of the transcutaneous connector and establishes an electrical connection between the second plurality of electrodes and respective ones of the plurality of electrical interconnections of the subcutaneous port,

wherein an axis of the first channel is at an angle with respect to an axis of the second channel such that implanting the subcutaneous port within the subcutaneous tissue of the patient with the axis of the first channel pointing substantially parallel to a surface of the patient'"'"'s skin results in the axis of the second channel pointing, at an angle with respect to the surface of the patient'"'"'s skin, toward the surface of the patient'"'"'s skin to thereby provide access to the second aperture through a trocar or needle from the surface of the patient'"'"'s skin.

12. The annuloplasty ring assembly of claim 11, wherein the subcutaneous port further comprises a slanted target area that funnels the trocar or needle into the second aperture.

13. The annuloplasty ring assembly of claim 11, wherein the first end of the subcutaneous activation cable is coupled to the adjustable annuloplasty ring at a location corresponding to a P2/P3 leaflet junction of a mitral valve when the adjustable annuloplasty ring is implanted around the annulus of the mitral valve.

14. The annuloplasty ring assembly of claim 11, wherein the first end of the subcutaneous activation cable is coupled to the adjustable annuloplasty ring at a location corresponding to a P1/P2 leaflet junction of a mitral valve when the adjustable annuloplasty ring is implanted around the annulus of the mitral valve.

15. The annuloplasty ring assembly of claim 11, further comprising a thermocouple to measure a temperature within the adjustable annuloplasty ring, the subcutaneous activation cable further comprising one or more leads for communicating signals between the thermocouple and the subcutaneous port.

16. An annuloplasty ring assembly, comprising:

an adjustable annuloplasty ring including a body member comprising shape memory material to change a dimension of the adjustable annuloplasty ring in response to application of an activation energy;

a subcutaneous activation cable to provide the activation energy to the shape memory material of the adjustable annuloplasty ring, the subcutaneous activation cable comprising;

a first end coupled to the adjustable annuloplasty ring; and

a second end comprising a subcutaneous connector including a first plurality of electrodes; and

a subcutaneous port implantable in subcutaneous tissue within a patient, the subcutaneous port comprising;

a first interface to receive the subcutaneous connector of the subcutaneous activation cable;

a second interface to receive a transcutaneous connector inserted through the patient'"'"'s skin, the transcutaneous connector providing the activation energy to the subcutaneous port through a second plurality of electrodes;

a plurality of electrical interconnections to establish electrical communication between the first plurality of electrodes of the subcutaneous connector and respective ones of the second plurality of electrodes of the transcutaneous connector; and

a heating element coiled around at least a portion of the body member comprising the shape memory material, wherein the activation energy comprises radio frequency (RF) energy, and wherein the heating element generates thermal energy in response to receiving the RF energy through the subcutaneous activation cable,

wherein the heating element comprises a variable density coil that transfers thermal energy to the body member at a higher rate in areas corresponding to relatively higher coil densities.

17. The annuloplasty ring assembly of claim 16, wherein the subcutaneous connector comprises an in-line connector such that the first plurality of electrodes comprise electrically conductive bands arranged along an axis of the subcutaneous activation cable to form a male connector.

18. The annuloplasty ring assembly of claim 17, wherein the first interface of the subcutaneous port comprises a first aperture providing access to a first channel within the subcutaneous port to form a female connector that receives the male in-line connector of the subcutaneous connector and establishes an electrical connection between the first plurality of electrodes and respective ones of the plurality of electrical interconnections of the subcutaneous port.

19. The annuloplasty ring assembly of claim 18, wherein the second interface of the subcutaneous port comprises a second aperture providing access to a second channel within the subcutaneous port to form a female connector that receives a male in-line connector of the transcutaneous connector and establishes an electrical connection between the second plurality of electrodes and respective ones of the plurality of electrical interconnections of the subcutaneous port.

20. The annuloplasty ring assembly of claim 16, wherein the subcutaneous port comprises a plurality of suture apertures that are each configured to receive a suture to attach the subcutaneous port to the subcutaneous tissue.

21. The annuloplasty ring assembly of claim 20, wherein the suture apertures are located on a flange of the port, and wherein the flange extends away from the port.

22. The annuloplasty ring assembly of claim 16, wherein the first end of the subcutaneous activation cable is coupled to the adjustable annuloplasty ring at a location corresponding to a P2/P3 leaflet junction of a mitral valve when the adjustable annuloplasty ring is implanted around the annulus of the mitral valve.

23. The annuloplasty ring assembly of claim 16, wherein the first end of the subcutaneous activation cable is coupled to the adjustable annuloplasty ring at a location corresponding to a P1/P2 leaflet junction of a mitral valve when the adjustable annuloplasty ring is implanted around the annulus of the mitral valve.

24. The annuloplasty ring assembly of claim 16, further comprising a thermocouple to measure a temperature within the adjustable annuloplasty ring, the subcutaneous activation cable further comprising one or more leads for communicating signals between the thermocouple and the subcutaneous port.

25. An annuloplasty ring assembly, comprising:

an adjustable annuloplasty ring including a body member comprising shape memory material to change a dimension of the adjustable annuloplasty ring in response to application of an activation energy;

a subcutaneous activation cable to provide the activation energy to the shape memory material of the adjustable annuloplasty ring, the subcutaneous activation cable comprising;

a coaxial cable comprising an inner coil and an outer coil separated from one another by an insulator;

a first end coupled to the adjustable annuloplasty ring; and

a second end comprising a subcutaneous connector including a first plurality of electrodes; and

a subcutaneous port implantable in subcutaneous tissue within a patient, the subcutaneous port comprising;

a first interface to receive the subcutaneous connector of the subcutaneous activation cable;

a second interface to receive a transcutaneous connector inserted through the patient'"'"'s skin, the transcutaneous connector providing the activation energy to the subcutaneous port through a second plurality of electrodes; and

a plurality of electrical interconnections to establish electrical communication between the first plurality of electrodes of the subcutaneous connector and respective ones of the second plurality of electrodes of the transcutaneous connector.

26. The annuloplasty ring assembly of claim 25, wherein the subcutaneous connector comprises an in-line connector such that the first plurality of electrodes comprise electrically conductive bands arranged along an axis of the subcutaneous activation cable to form a male connector.

27. The annuloplasty ring assembly of claim 26, wherein the first interface of the subcutaneous port comprises a first aperture providing access to a first channel within the subcutaneous port to form a female connector that receives the male in-line connector of the subcutaneous connector and establishes an electrical connection between the first plurality of electrodes and respective ones of the plurality of electrical interconnections of the subcutaneous port.

28. The annuloplasty ring assembly of claim 27, wherein the second interface of the subcutaneous port comprises a second aperture providing access to a second channel within the subcutaneous port to form a female connector that receives a male in-line connector of the transcutaneous connector and establishes an electrical connection between the second plurality of electrodes and respective ones of the plurality of electrical interconnections of the subcutaneous port.

29. The annuloplasty ring assembly of claim 25, wherein the subcutaneous port comprises a plurality of suture apertures that are each configured to receive a suture to attach the subcutaneous port to the subcutaneous tissue.

30. The annuloplasty ring assembly of claim 29, wherein the suture apertures are located on a flange of the port, and wherein the flange extends away from the port.

31. The annuloplasty ring assembly of claim 25, wherein the first end of the subcutaneous activation cable is coupled to the adjustable annuloplasty ring at a location corresponding to a P2/P3 leaflet junction of a mitral valve when the adjustable annuloplasty ring is implanted around the annulus of the mitral valve.

32. The annuloplasty ring assembly of claim 25, wherein the first end of the subcutaneous activation cable is coupled to the adjustable annuloplasty ring at a location corresponding to a P1/P2 leaflet junction of a mitral valve when the adjustable annuloplasty ring is implanted around the annulus of the mitral valve.

33. The annuloplasty ring assembly of claim 25, further comprising a thermocouple to measure a temperature within the adjustable annuloplasty ring, the subcutaneous activation cable further comprising one or more leads for communicating signals between the thermocouple and the subcutaneous port.

34. An annuloplasty ring assembly, comprising:

an adjustable annuloplasty ring including a body member comprising shape memory material to change a dimension of the adjustable annuloplasty ring in response to application of an activation energy;

a subcutaneous activation cable to provide the activation energy to the shape memory material of the adjustable annuloplasty ring, the subcutaneous activation cable comprising;

a first end coupled to the adjustable annuloplasty ring; and

a second end comprising a subcutaneous connector including a first plurality of electrodes;

a resistive element with a resistive value selected to uniquely identify at least one of the adjustable annuloplasty ring and the subcutaneous activation cable; and

a subcutaneous port implantable in subcutaneous tissue within a patient, the subcutaneous port comprising;

a first interface to receive the subcutaneous connector of the subcutaneous activation cable;

a second interface to receive a transcutaneous connector inserted through the patient'"'"'s skin, the transcutaneous connector providing the activation energy to the subcutaneous port through a second plurality of electrodes; and

a plurality of electrical interconnections to establish electrical communication between the first plurality of electrodes of the subcutaneous connector and respective ones of the second plurality of electrodes of the transcutaneous connector.

35. The annuloplasty ring assembly of claim 34, wherein the subcutaneous connector comprises an in-line connector such that the first plurality of electrodes comprise electrically conductive bands arranged along an axis of the subcutaneous activation cable to form a male connector.

36. The annuloplasty ring assembly of claim 35, wherein the first interface of the subcutaneous port comprises a first aperture providing access to a first channel within the subcutaneous port to form a female connector that receives the male in-line connector of the subcutaneous connector and establishes an electrical connection between the first plurality of electrodes and respective ones of the plurality of electrical interconnections of the subcutaneous port.

37. The annuloplasty ring assembly of claim 36, wherein the second interface of the subcutaneous port comprises a second aperture providing access to a second channel within the subcutaneous port to form a female connector that receives a male in-line connector of the transcutaneous connector and establishes an electrical connection between the second plurality of electrodes and respective ones of the plurality of electrical interconnections of the subcutaneous port.

38. The annuloplasty ring assembly of claim 34, wherein the subcutaneous port comprises a plurality of suture apertures that are each configured to receive a suture to attach the subcutaneous port to the subcutaneous tissue.

39. The annuloplasty ring assembly of claim 38, wherein the suture apertures are located on a flange of the port, and wherein the flange extends away from the port.

40. The annuloplasty ring assembly of claim 34, wherein the first end of the subcutaneous activation cable is coupled to the adjustable annuloplasty ring at a location corresponding to a P2/P3 leaflet junction of a mitral valve when the adjustable annuloplasty ring is implanted around the annulus of the mitral valve.

41. The annuloplasty ring assembly of claim 34, wherein the first end of the subcutaneous activation cable is coupled to the adjustable annuloplasty ring at a location corresponding to a P1/P2 leaflet junction of a mitral valve when the adjustable annuloplasty ring is implanted around the annulus of the mitral valve.

42. The annuloplasty ring assembly of claim 34, further comprising a thermocouple to measure a temperature within the adjustable annuloplasty ring, the subcutaneous activation cable further comprising one or more leads for communicating signals between the thermocouple and the subcutaneous port.