Prosthetic intervertebral spinal disc with integral microprocessor

• US 7,794,499 B2
• Filed: 06/08/2004
• Issued: 09/14/2010
• Est. Priority Date: 06/08/2004
• Status: Active Grant

• Current Assignee: Theken Spine LLC (Orthofix Medical Inc.)
• Original Assignee: Theken Disc, LLC (Integra LifeSciences Holdings Corporation)
• Inventors: Theken, Randall Raymond, Navarro, Richard Robert, Cole, Christopher Paul
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): HAMMOND, ELLEN CHRISTINA
• Application Number:
  US10/863,858
• Publication Number:
  US 20050273170A1
• Time in Patent Office: 2,289 Days
• Field of Search: 623 1711- 1716, 623/914, 600/594
• US Class Current: 623/17.11
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2002/30069 elastomeric
• CPC Class Codes: A61F 2002/30087 piezoelectric
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30462 retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30563 having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/3067 for data transfer
• CPC Class Codes: A61F 2002/4666 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0015 Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2250/0002 for data transfer
• CPC Class Codes: Y10S 623/914 Bone

Abstract

A device for storing data related to movement of a prosthetic implant includes at least one transducer for generating at least one real time movement signal responsive to movement within the prosthetic implant. A processor generates movement data parameters and associated time stamps in response to the real time movement signal. The generated data parameters and time stamps are stored within a memory associated with the processor. A communications link may be used to selectively access the movement data parameters and the time stamps in the memory from an external source.

Claims

1. A prosthetic implant for implanting in a body, the implant comprising:

a support member for interfacing with bone;

at least one sensor for measuring parameters associated with the prosthetic implant;

a memory for storing an output of the at least one sensor for later retrieval;

a power management device for controlling operation of said memory, said power management device operable to apply operating power to said memory when storing information therein and retrieving information therefrom, and said power management device operable to reduce power applied to said memory device at times when information is not being stored therein or retrieved therefrom; and

a telemetry device operable to transmit at least some contents of said memory in response to an external request.

2. The prosthetic implant of claim 1, wherein said support member is adapted to adhere to said bone.

3. The prosthetic implant of claim 1, wherein said support member includes a first interface surface for interfacing with bone on one side of an articulating joint and a second interface surface for interfacing with bone on another side of the articulating joint, and said sensor disposed proximate to one of said first or second interface surfaces.

4. The prosthetic implant of claim 3, wherein said memory is disposed between said first and second interface surfaces.

5. The prosthetic implant of claim 3, wherein said first and second interface surfaces are associated with first and second support structures formed of a first material, and further comprising a third support structure disposed between said first and second support structures and comprising a second material different from said first material.

6. The prosthetic implant of claim 5, wherein said second material is a resilient material and said first material is a non-resilient material.

7. The prosthetic implant of claim 6, wherein said sensor is disposed on a surface of one of said first and second support structures facing an interface therewith of said third support structure.

8. The prosthetic implant of claim 1, wherein the prosthetic implant is an implantable vertebral disk.

9. The prosthetic implant of claim 1, and further comprising a power source for powering said memory.

10. The prosthetic implant of claim 9, wherein said telemetry device is powered by said power source.

11. The prosthetic implant of claim 1, wherein said power management device includes:

an activity detector for detecting a change in an output of said sensor; and

a power switch for selectively applying power to said memory in response to said activity detector detecting a change in the output of said sensor that exceeds a predetermined threshold.

12. The method of claim 11, further comprising a processing unit, said processing unit controlling the placing of information in said memory and the retrieval of information therefrom, said processing unit having the power thereto controlled by said power management device, such that power thereto can be decreased when information is not being placed in said memory or being retrieved therefrom.

13. The prosthetic implant of claim 12, wherein said processing unit, when operating in a reduced power mode, is operable to control said power switch and is operable to process the output of said activity detector.

14. The prosthetic implant of claim 1, wherein the at least one sensor measures at least one force associated with said support member.

15. The prosthetic implant of claim 1, wherein the at least one sensor measures an inclination associated with said support member.

16. The prosthetic implant of claim 1, wherein the at least one sensor measures a temperature associated with said support member.

17. A prosthetic implant for implanting in a body, the implant comprising:

a support member for interfacing with bone;

at least one sensor for measuring parameters associated with the prosthetic implant and providing an output signal representative thereof;

a processing unit for receiving the output of said at least one sensor and processing said received output; and

a memory for storing information representative of the output of said at least one sensor under control of said processing unit;

an activity detector for detecting a change in the output of said sensor; and

a power switch for selectively applying power to said memory in response to said activity detector detecting a change in the output of said sensor that exceeds a predetermined threshold and for causing said processing unit to operate in a reduced power mode when the predetermined threshold output of said sensor is not exceeded for a predetermined period of time.

18. The prosthetic implant of claim 17, wherein said memory comprises a non-volatile memory which is controlled by said power management device to apply power to said memory at least during placing of information therein and to reduce power thereto during at least a portion of the time that said processing unit operates in reduced power mode.

19. The prosthetic implant of claim 17, and further comprising a telemetry device operable to transmit at least some contents of said memory in response to an external request.

20. The prosthetic implant of claim 19, wherein said power management device is operable to apply power to said telemetry device when information is transferred by said telemetry device.

21. The prosthetic implant of claim 19, wherein said telemetry device is operable to receive information from an external device for storage in said memory.

22. The prosthetic implant of claim 19, wherein said telemetry device is operable to receive information from an external device to define an end of a reduced power time period during which said processing unit operates in a reduced power mode.

23. The prosthetic implant of claim 17, wherein the predetermined threshold is selectively programmable.

24. The prosthetic implant of claim 17, wherein the predetermined threshold is automatically altered responsive to the sensor exceeding the predetermined threshold a predetermined number of times in a second predetermined time period.

25. The prosthetic implant of claim 17, wherein said processing unit, when operating in said reduced power mode, is operable to control said power switch and is operable to process the output of said activity detector.

26. The prosthetic implant of claim 17, wherein said activity detector is non power consuming at least prior to any detection of activity from said sensor.

27. The prosthetic implant of claim 17, wherein said support member is adhered to said bone.

28. The prosthetic implant of claim 17, wherein said support member includes a first interface surface for interfacing with bone on one side of an articulating joint and a second interface surface for interfacing with bone on another side of the articulating joint, and said sensor disposed proximate to one of said first or second interface surfaces.

29. The prosthetic implant of claim 28, wherein said processing unit is disposed between said first and second interface surfaces.

30. The prosthetic implant of claim 28, wherein said first and second interface surfaces are associated with first and second support structures formed of a first material, and further comprising a third support structure disposed between said first and second support structures and comprised of a second material different from said first material.

31. The prosthetic implant of claim 30, wherein said second material is a resilient material and said first material is a non-resilient material.

32. The prosthetic implant of claim 31, wherein said sensor is disposed on the surface of one of said first and second support structures facing the interface therewith of said third support structure.

33. The prosthetic implant of claim 17, wherein the prosthetic implant is an implantable vertebral disk.

34. The prosthetic implant of claim 17, wherein said sensor comprises a dynamic force sensor.

35. The prosthetic implant of claim 34, wherein said dynamic force sensor comprises a piezoelectric sensor.

36. The prosthetic implant of claim 17, wherein said power management device is operable to place said processing unit in a non-reduced power mode at times other than said predetermined time periods such that said processing unit can process the information output by said sensor in said non-reduced power mode.

37. The prosthetic implant of claim 17, wherein the at least one sensor measures at least one force associated with said support member.

38. The prosthetic implant of claim 17, wherein the at least one sensor is operable to measure an inclination associated with said support member.

39. The prosthetic implant of claim 17, wherein the at least one sensor measures a temperature associated with said support member.

40. An implant for use within a body proximate to a particular location, comprising:

at least one sensor for measuring parameters associated with the particular location;

a time base for providing temporal information;

a memory for retrievably storing the output of the at least one sensor in association with the temporal information wherein said memory is a non-volatile memory;

a power management device for controlling operation of said memory, said power management device operable to apply power to said memory when placing information therein and retrieving information therefrom, and said power management device operable to reduce power applied to said memory at times when information is not being stored therein or retrieved therefrom; and

a telemetry device operable to transmit the at least some contents of said memory in response to an external request.

41. The implant of claim 40, further comprising a power source for powering said memory.

42. The implant of claim 41, wherein said telemetry device is powered by said power source.

43. The implant of claim 40, wherein said power management device includes:

an activity detector for detecting a change in the output of said sensor; and

a power switch for selectively applying power to said memory in response to said activity detector detecting a change in the output of said sensor that exceeds a predetermined threshold.

44. The implant of claim 43, further comprising a processing unit powered by said power source, said processing unit controlling the placing of information into said memory and the retrieval of information therefrom, said processing unit having the power applied thereto controlled by said power management device, such that power thereto applied to the processing unit can be decreased when information is not being placed into said memory or being retrieved therefrom.

45. The implant of claim 44, wherein said processing unit, when operating in a reduced power mode is operable to control said power switch and is operable to process the output of said activity detector.

46. The implant of claim 40, wherein the at least one sensor measures temperature of the body proximate to the particular location.

47. A prosthetic implant system, the system comprising:

a prosthetic spinal disc having a sensor for measuring a parameter associated with the prosthetic spinal disc and a transmitter suitable to transmit data related to the measured parameter;

an alarm monitor for receiving the transmitted data and for generating an alarm upon meeting of a predetermined criterion;

an activity detector for detecting a change in the output of said sensor; and

a power switch for selectively applying power to said memory in response to said activity detector detecting a change in the output of said sensor that exceeds a predetermined threshold.