Prosthetic intervertebral spinal disc with integral microprocessor

• US 20050273170A1
• Filed: 06/08/2004
• Published: 12/08/2005
• Est. Priority Date: 06/08/2004
• Status: Active Grant

• Current Assignee: Theken Spine LLC (Orthofix Medical Inc.)
• Original Assignee: Theken Spine LLC (Orthofix Medical Inc.)
• Inventors: Theken, Randall Raymond, Navarro, Richard Robert, Cole, Christopher Paul
• Granted Patent: US 7,794,499 B2
• Time in Patent Office: Days
• US Class Current: 623/17.130
• 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. An prosthetic implant for implanting in a body, comprising:

a support member for interfacing with bone;

at least one sensor for measuring parameters associated with the support member;

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

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

2. The prosthetic implant of claim 1, wherein said support member is adhered 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 the other side of the articulating joint, and said sensor disposed in close proximity 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 4, 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 than 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 the surface of one of said first and second support structures facing the interface therewith of said third support structure.

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 9, and further comprising a power management device for controlling the operation of said memory wherein said memory is a non-volatile 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.

12. The prosthetic implant of claim 11, 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 activity level.

13. The method of claim 12, and further comprising a processing unit powered by said power source, said processing unit controlling the storage 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 stored in said memory or being retrieved therefrom.

14. The prosthetic implant of claim 13, 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 device.

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

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

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

8. The prosthetic implant 7, where the prosthetic implant is an implantable vertebral disk.

18. An prosthetic implant for implanting in a body, comprising:

a support member for interfacing with bone;

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

a power source;

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

a power management system for causing said processing unit to operate in a reduced power mode during predetermined time periods, such that less power is consumed from said power source.

19. The prosthetic implant of claim 18, and further comprising a memory for storing information representative of the output of said at least one sensor under control of said processing unit.

20. The prosthetic implant of claim 19, wherein said memory a non-volatile memory which is controlled by said power management device to apply power thereto at least during storing of information thereto and reduce power thereto during at least a portion of the time that power is reduced to said processing unit.

21. The prosthetic implant of claim 19, and further comprising a telemetry device operable to transmit the contents of said memory in response to an external request external to the body.

22. The prosthetic implant of claim 21, wherein said telemetry device is powered by said power source and said power management device is operable to apply power to said telemetry device when information is transferred by said telementry device.

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

24. The prosthetic implant of claim 21, wherein said telemetry device is operable to receive information from an external source to define the end of said predetermined time period such that said processing unit operates in a high power mode consuming more power than in said reduced power mode.

25. The prosthetic implant of claim 20, 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 activity level.

26. The prosthetic implant of claim 25, wherein the predetermined activity level is selectively programmable.

27. The prosthetic implant of claim 25, wherein the predetermined activity level is automatically altered responsive to the sensor exceeding the predetermined activity level a predetermined number of times in a predetermined time period.

28. The prosthetic implant of claim 25, 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.

29. The implantable device of claim 25, wherein said activity detector is non power consuming at least prior to any detection of activity from said sensor.

30. The prosthetic implant of claim 18, wherein said support member is adhered to said bone.

31. The prosthetic implant of claim 30, 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 the other side of the articulating joint, and said sensor disposed in close proximity to one of said first or second interface surfaces.

32. The prosthetic implant of claim 31, wherein said processing unit is disposed between said first and second interface surfaces.

33. The prosthetic implant of claim 32, 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 than said first material.

34. The prosthetic implant of claim 33, wherein said second material is a resilient material and said first material is a non-resilient material.

35. The prosthetic implant of claim 34, 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.

37. The prosthetic implant of claim 18, wherein said sensor comprises a dynamic force sensor.

38. The prosthetic implant of claim 37, wherein said dynamic force sensor comprises a piezoelectric sensor.

39. The method of claim 38, 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.

40. The prosthetic implant of claim 18, wherein the at least one sensor measures forces associated with said support member.

41. The prosthetic implant of claim 18, wherein the at least one sensor measures inclination associated with said support member.

42. The prosthetic implant of claim 18, wherein the at least one sensor measures temperature associated with said support member.

36. The prosthetic implant 35, where the prosthetic implant is an implantable vertebral disk.

43. An apparatus for storing data relating to movement of a prosthetic implant, comprising:

at least one transducer for generating at least one real time movement signal responsive to movement of the prosthetic implant;

a processor for generating movement data parameters from the at least one real time movement signal and for generating a time stamp associated with a time of generation of the at least one real time movement signal;

a memory for storing the movement data parameters and the associated time stamp;

a communications link for selectively accessing the movement data parameters and the associated time stamp from an external source.

44. The apparatus of claim 43, wherein the processor enters a low power mode of operation when the at least one real time movement signal has not been received for a predetermined period of time.

45. The apparatus of claim 44, wherein the processor enters a second mode of operation from the low power mode of operation when the at least one real time movement signal is received from the at least one transducer.

46. The apparatus of claim 43 further including:

circuitry, responsive to the selective accessing of the movement data parameters by the external source, for charging a battery powering the processor.

47. The apparatus of claim 43, wherein the processor uploads the real time movement data and the associated time stamp from the memory to the external source in response to a request from the external source.

48. The apparatus of claim 43, wherein the movement data parameters comprise at least a maximum value of the at least one real time movement signal and a slope of the at least one real time movement signal.

49. The apparatus of claim 43, wherein the at least one transducer comprises a piezoelectric transducer.

50. The apparatus of claim 43, wherein the at least one transducer comprises an accelerometer.

51. An apparatus located within a prosthetic spinal disc for storing data relating to movement of the prosthetic spinal disc, comprising:

a plurality of transducers for generating real time movement signals responsive to movement of the prosthetic spinal disc;

a memory for storing movement data parameters and an associated time stamp;

a processor for generating the movement data parameters from the real time movement signals, for generating the time stamp associated with a time of generation of the real time movement signals and for uploading the movement data parameters from the memory to an external source in response to a request from the external source;

wherein the processor enters a low power mode of operation when the real time movement signals have not been received from the plurality of transducers for a predetermined period of time, and enters a second mode of operation from the low power mode of operation when the real time movement signals are received from the plurality of transducers; and

a wireless interface for selectively uploading the real time movement data to the external source.

52. The apparatus of claim 51 further including:

circuitry, responsive to the selective accessing of the movement data parameters by the external source, for charging a battery powering the processor.

53. The apparatus of claim 51, wherein the processor uploads the real time movement data and the associated time stamp from the memory to the external source in response to a request from the external source.

54. The apparatus of claim 51, wherein the at least one transducer comprises a piezoelectric transducer.

55. The apparatus of claim 51, wherein the at least one transducer comprises an accelerometer.

56. An apparatus for storing data relating to movement of a prosthetic prosthetic implant, comprising:

an upper plate for connecting the insert to a first portion of a joint;

a lower plate for connecting the insert to a second portion of the joint;

an elastomeric layer connecting separating the upper plate from the lower plate, the elastomeric layer enabling independent movement of the upper plate and the lower plate with respect to each other;

a plurality of transducers located on at least one of the upper plate and the lower plate for generating real time movement signals responsive to movement of the upper plate and the lower plate;

a memory for storing movement data parameters;

a wireless interface for selectively uploading the movement data parameters to an external source;

a processor for generating the movement data parameters responsive to the real time movement signals, storing the movement data parameters in the memory and for providing the movement data parameters from the memory to an external source in response to a request from the external source, the processor having a sleep mode of operation entered when the real time movement signals have not been received from the plurality of transducers for a predetermined period of time and a wake mode of operation entered from the sleep mode of operation when the real time movement signals are received from the plurality of transducers or when the external source provides the request for the real time movement signals.

57. The apparatus for claim 56, wherein the processor further generates a time stamp indicating a time the real time movement signals associated with the movement data parameters were generated and stores the movement data parameters with the associated time stamp

58. The apparatus of claim 56 further including:

circuitry, responsive to the selective accessing of the movement data parameters by the external source, for charging a battery powering the processor.

59. The apparatus of claim 56, wherein the processor uploads the real time movement data and the associated time stamp from the memory to the external source in response to a request from the external source.

60. The apparatus of claim 56, wherein the at least one transducer comprises a piezoelectric transducer.

61. The apparatus of claim 56, wherein the at least one transducer comprises an accelerometer.

62. A method monitoring activity on a prosthetic implant in a body, comprising the steps of

detecting movement within the prosthetic implant;

generating a signal representative of parameters associated with said movement;

removing a processing unit from a low power mode of operation to a second mode of operation responsive to the signal representative of said parameters;

storing said parameters for later retrieval; and

transmitting said parameters in response to an external request to the body.

returning the processing unit to the sleep mode of operation if no movement within the prosthetic implant is detected for a predetermined period of time.

63. The method of claim 62, wherein the step of generating further includes the steps of processing a real time signal to generate a plurality of parameters representative of the real time signal.

64. The method of claim 63 wherein the step of storing further include the steps of:

generating a time stamp indicating a time the parameters were generated; and

storing the time stamp in association with the parameters.

65. The method of claim 63, wherein the step of processing further includes the step of processing the real time signal to generate a maximum value parameter representing a maximum value of the real time signal.

66. The method of claim 63, wherein the step of processing further includes the step of processing the real time signal to generate a slope parameter representing a maximum change of intensity value of the real time signal.

67. The method of claim 62, wherein the step of transmitting further includes the steps of:

receiving a request to upload the parameters from an external location;

selectively uploading the parameters in response to the request.

68. The method of claim 62, further including the step of returning the processing unit to the sleep mode of operation if no movement within the prosthetic implant is detected for a predetermined period of time.

69. The method of claim 68 further including the steps of removing a processing unit from a low power mode of operation to a second mode of operation responsive to the signal representative of said parameters.

70. A method monitoring activity on a prosthetic implant, comprising the steps of:

detecting movement within the prosthetic implant;

generating a real time signal representative of said movement;

processing the real time signal to generate a plurality of parameters representative of the real time signal;

generating a time stamp indicating a time the real time movement signals associated with the plurality of parameters were generated;

storing the plurality of parameters representative of said real time signal and the time stamp associated with the plurality of parameters;

receiving a request to upload the data representative of said real time signal from an external location;

selectively uploading the data representative of said real time signal in response to the request.

71. The method of claim 70, wherein the step of processing further includes the step of processing the real time signal to generate a maximum value parameter representing a maximum value of the real time signal.

72. The method of claim 70, wherein the step of processing further includes the step of processing the real time signal to generate a slope parameter representing a maximum change of intensity value of the real time signal.

73. The method of claim 70 further including removing a processing unit from a low power mode of operation to a second mode of operation responsive to the real time signal representative of said movement.

74. The method of claim 73 further including returning the processing unit to the sleep mode of operation if no movement within the prosthetic implant is detected for a predetermined period of time.

75. An implant 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 storing the output of the at least one sensor in association with temporal information for later retrieval; and

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

76. The implant of claim 75, and further comprising a power source for powering said memory.

77. The implant of claim 76, wherein said telemetry device is powered by said power source.

78. The implant of claim 76, and further comprising a power management device for controlling the operation of said memory wherein said memory is a non-volatile 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.

79. The implant of claim 78, 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 activity level.

80. The method of claim 79, and further comprising a processing unit powered by said power source, said processing unit controlling the storage 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 stored in said memory or being retrieved therefrom.

81. The implant of claim 80, 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 device.

82. The implant of claim 75, wherein the at least one sensor measures temperature of the body proximate to the particular location.