Smart joint implant sensors

• US 8,956,418 B2
• Filed: 08/03/2007
• Issued: 02/17/2015
• Est. Priority Date: 02/18/2005
• Status: Active Grant

• Current Assignee: Zimmer Incorporated (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Incorporated (Zimmer Biomet Holdings, Inc.)
• Inventors: Wasielewski, Ray C., Komistek, Richard D., Mahfouz, Mohamed R.
• Primary Examiner(s): Snow, Bruce E
• Assistant Examiner(s): HOBAN, MELISSA A
• Application Number:
  US11/890,307
• Publication Number:
  US 20080065225A1
• Time in Patent Office: 2,755 Days
• Field of Search: 623/914, 623/18.11
• US Class Current: 623/18.11
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61B 5/4851 Prosthesis assessment or monitoring
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2/488 Means for detecting or monitoring wear
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/3067 for data transfer
• CPC Class Codes: A61F 2002/30673 : Lubricating means, e.g. synovial pocket
• CPC Class Codes: A61F 2002/30878 : with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/4632 : using computer-controlled surgery, e.g. robotic surgery
• CPC Class Codes: A61F 2002/4666 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2250/0002 : for data transfer
• 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: G16H 40/20 : for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 40/67 : for remote operation

Abstract

A prosthesis for implantation into a mammalian body, the device comprising: (a) a prosthesis for implantation into a mammalian body that includes a sensor array comprising a plurality of sensors mounted to the prosthesis; and (b) an electronics structure for receiving signals from the sensor array and wirelessly transmitting representative signals to a remote receiver, where the plurality of sensors are operative to sense pressure, applied to the prosthesis by another object, in at least two axes generally perpendicular to one another.

Claims

1. A prosthetic device for implantation into a mammalian body having a bodily fluid, the prosthetic device prosthesis comprising:

a prosthesis having at least one articular surface adapted to form a joint with one of a bone and a second prosthetic implant, the one of the bone and the second prosthetic implant applying a load to the articular surface of the prosthesis after implantation of the prosthesis into the mammalian body, the prosthesis for being bathed by the bodily fluid when implanted in the mammalian body, the prosthesis including a microchannel and a micropump in fluid communication with the microchannel to pump the bodily fluid through the microchannel,

a sensor array comprising a plurality of sensors mounted to the prosthesis; and

an electronics structure for receiving signals from the sensor array and wirelessly transmitting representative signals to a remote receiver;

wherein at least one of the plurality of sensors is operative to sense pressure, applied to the at least one articular surface of the prosthesis at the joint, in at least two axes generally perpendicular to one another, and

wherein at least one sensor of the plurality of sensors is in fluid communication with the microchannel.

2. The prosthetic device of claim 1, wherein the electronics structure includes a timing circuit configured to automatically activate the sensor array and to automatically deactivate the sensor array.

3. The prosthetic device of claim 1, wherein the plurality of sensors include at least one of resistive microcantilevers, piezoelectric microcantilevers, and microcapacitor sensors.

4. The prosthetic device of claim 1, wherein the prosthesis includes at least one of a knee replacement femoral prosthesis, a knee replacement tibial prosthesis, a knee replacement tibial tray prosthesis, a hip replacement femoral prosthesis, a hip replacement acetabular cup prosthesis, a hip replacement acetabular cup insert prosthesis, a trial knee replacement femoral prosthesis, a trial knee replacement tibial prosthesis, a trial knee replacement tibial tray prosthesis, a trial hip replacement femoral prosthesis, a trial hip replacement acetabular cup prosthesis, and a trial hip replacement acetabular cup insert prosthesis.

5. The prosthetic device of claim 1, wherein the electronics structure includes a microcontroller, an amplifier, and a transmitter, the microcontroller being operatively coupled to the amplifier to amplify the signals from the sensor array and being operatively coupled to the transmitter to transmit amplified signals to the remote receiver, the remote receiver being located outside the mammalian body.

6. The prosthetic device of claim 1, wherein the electronics structure includes an application specific integrated circuit, which includes a filter for filtering out low frequency noise.

7. The prosthetic device of claim 1, wherein the electronics structure includes an application specific integrated circuit, which includes a multiplexer for multiplexing signals from the sensor array.

8. The prosthetic device of claim 1, wherein the electronics structure includes an application specific integrated circuit, which includes an analog-to-digital converter for converting analog signals from the sensor array to digital signals.

9. The prosthetic device of claim 1, wherein the electronics structure includes an application specific integrated circuit, which includes a processor for processing signals from the sensor array.

10. The prosthetic device of claim 1, wherein at least one of the plurality of sensors is operative to sense temperature.

11. The prosthetic device of claim 1, wherein the at least one of the plurality of sensors operative to sense pressure applied to the prosthesis comprise a first sensor of a first type selected from an interdigitated capacitor, a capacitor having parallel plates and sensing forces perpendicular to the plates, and a differential capacitor sensing shear forces.

12. The prosthetic device of claim 11, further comprising a second sensor of a second type selected from the interdigitated capacitor, the capacitor having parallel plates and sensing forces perpendicular to the plates, and the differential capacitor sensing shear forces, the second type being different than the first type.

13. The prosthetic device of claim 12, wherein the first sensor and the second sensor are in a plane.

14. The prosthetic device of claim 1, wherein the at least one sensor of the plurality of sensors operative to sense pressure in at least two axes include a first sensor sensing pressure in a first axis and a second sensor sensing pressure in a second axis which is angled relative to the first axis.

15. The prosthetic device of claim 1, wherein the at least one sensor of the plurality of sensors in fluid communication with the microchannel comprises a microcantilever sensor detecting at least one of a predetermined component of the bodily fluid in the microchannel, a predetermined contaminant of the bodily fluid in the microchannel, and a predetermined property of the bodily fluid in the microchannel.

16. A prosthetic device for implantation into a mammalian body having bodily fluid, the prosthetic device comprising:

a prosthesis having at least one articular surface adapted to form a joint with one of a bone and a second prosthetic implant, the one of the bone and the second prosthetic implant applying a load to the articular surface of the prosthesis after implantation of the prosthesis into the mammalian body, the prosthesis for being bathed by the bodily fluid when implanted in the mammalian body, the prosthesis including a microchannel and a micropump in communication with the microchannel to pump the bodily fluid through the microchannel;

a sensor array comprising a plurality of sensors mounted to the prosthesis; and

an electronics structure for receiving signals from the sensor array and wirelessly transmitting representative signals to a remote receiver;

wherein at least one of the plurality of sensors is operative to sense pressure, applied to the at least one articular surface of the prosthesis at the joint, in at least two axes generally perpendicular to one another.

17. The prosthetic device of claim 16, wherein the electronics structure includes a timing circuit configured to automatically activate the sensor array and to automatically deactivate the sensor array.

18. The prosthetic device of claim 16, wherein the plurality of sensors includes at least one of resistive microcantilevers, piezoelectric microcantilevers, and microcapacitor sensors.

19. The prosthetic device of claim 16, wherein the prosthesis includes at least one of a knee replacement femoral prosthesis, a knee replacement tibial prosthesis, a knee replacement tibial tray prosthesis, a hip replacement femoral prosthesis, a hip replacement acetabular cup prosthesis, a hip replacement acetabular cup insert prosthesis, a trial knee replacement femoral prosthesis, a trial knee replacement tibial prosthesis, a trial knee replacement tibial tray prosthesis, a trial hip replacement femoral prosthesis, a trial hip replacement acetabular cup prosthesis, and a trial hip replacement acetabular cup insert prosthesis.

20. The prosthetic device of claim 16, wherein at least one sensor of the plurality of sensors of the sensor array is operative to sense at least one of:

leukocyte concentration, neutrophil concentration, bacterial deoxyribonucleic acid concentration, antibody concentration, glucose concentration, excitatory amino acids concentration, lactate dehydrogenase concentration, hyaluronic acid concentration, uric acid concentration, calcium pyrophosphate concentration, beta-glucuronidase concentration, nerve growth factor concentration, insulin-like growth factor concentration, Caeruloplasmin concentration, and oxidase concentration.

21. The prosthetic device of claim 16, wherein the electronics structure includes a microcontroller and a transmitter.

22. The prosthetic device of claim 16, wherein the electronics structure includes an application specific integrated circuit, which includes a filter for filtering out low frequency noise.

23. The prosthetic device of claim 16, wherein the electronics structure includes an application specific integrated circuit, which includes an amplifier for amplifying signals from the sensor array.

24. The prosthetic device of claim 16, wherein the electronics structure includes an application specific integrated circuit, which includes a multiplexer for multiplexing signals from the sensor array.

25. The prosthetic device of claim 16, wherein the electronics structure includes an application specific integrated circuit, which includes an analog-to-digital converter for converting analog signals from the sensor array to digital signals.

26. The prosthetic device of claim 16, wherein the electronics structure includes an application specific integrated circuit, which includes a processor for processing signals from the sensor array.

27. The prosthetic device of claim 16, wherein at least one of the plurality of sensors comprises a microcantilever sensor detecting at least one of a predetermined component of the bodily fluid in the microchannel, a predetermined contaminant of the bodily fluid in the microchannel, and a predetermined property of the bodily fluid in the microchannel.

28. The prosthetic device of claim 27, wherein the microcantilever sensor comprises a first layer of a dual-layer structure and the electronics structure comprises a second layer of the dual-layer structure.

29. The prosthetic device of claim 27, wherein the microcantilever sensor comprises a reference cantilever exposed to a controlled environment devoid of biochemical agents and a sensing cantilever exposed to the bodily fluid and generating sensing signals, wherein vibration signals from the reference cantilever are operable to reduce interference in the sensing signals from the sensing cantilever caused by external vibrations.