CA2598391A1 - Smart joint implant sensors - Google Patents

Smart joint implant sensors Download PDF

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Publication number
CA2598391A1
CA2598391A1 CA002598391A CA2598391A CA2598391A1 CA 2598391 A1 CA2598391 A1 CA 2598391A1 CA 002598391 A CA002598391 A CA 002598391A CA 2598391 A CA2598391 A CA 2598391A CA 2598391 A1 CA2598391 A1 CA 2598391A1
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CA
Canada
Prior art keywords
prosthesis
synovial fluid
sensor array
concentration
foregoing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002598391A
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French (fr)
Other versions
CA2598391C (en
Inventor
Ray C. Wasielewski
Richard D. Komistek
Mohamed R. Mahfouz
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Zimmer Inc
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Individual
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Priority to CA2769658A priority Critical patent/CA2769658C/en
Publication of CA2598391A1 publication Critical patent/CA2598391A1/en
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Publication of CA2598391C publication Critical patent/CA2598391C/en
Expired - Fee Related legal-status Critical Current
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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.

Claims (50)

1. A prosthesis for implantation into a mammalian body, the device comprising:
a prosthesis for implantation into a mammalian body that includes 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.
2. The prosthesis of claim 1, wherein the sensor array includes sensors detecting at least one of a predetermined component, a predetermined contaminant, and a predetermined property.
3. The prosthesis of any one of the foregoing claims, wherein the plurality of sensors include at least one of an encapsulated sensor and a sensor in fluid communication with mammalian bodily fluids bathing the prosthesis.
4. The prosthesis of any one of the foregoing claims, wherein:
the electronics structure includes a timing circuit configured to automatically activate the sensor array and to automatically deactivate the sensor array.
5. The prosthesis of any one of the foregoing claims, wherein:
the plurality of sensors include at least one of resistive microcantilevers, piezoelectric microcantilevers, and microcapacitor sensors.
6. The prosthesis of any one of the foregoing claims, 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 trail hip replacement acetabular cup insert prosthesis.
7. The prosthesis of claim 6, wherein the prosthesis includes a knee replacement femoral prosthesis and the sensor array is embedded within the knee replacement femoral prosthesis.
8. The prosthesis of claim 6, wherein the prosthesis includes a knee replacement tibial prosthesis and the sensor array is embedded within the knee replacement tibial prosthesis.
9. The prosthesis of claim 6, wherein the prosthesis includes a knee replacement tibial tray prosthesis and the sensor array is embedded within the knee replacement tibial tray prosthesis.
10. The prosthesis of claim 6, wherein the prosthesis includes a hip replacement femoral prosthesis and the sensor array is embedded within the hip replacement femoral prosthesis.
11. The prosthesis of claim 6, wherein the prosthesis includes a hip replacement acetabular cup prosthesis and the sensor array is embedded within the hip replacement acetabular cup prosthesis.
12. The prosthesis of claim 6, wherein the prosthesis includes a hip replacement acetabular cup insert prosthesis and the sensor array is embedded within the hip replacement acetabular cup insert prosthesis.
13. The prosthesis of any one of the foregoing claims, wherein:
at least one 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.
14. The prosthesis of any one of the foregoing claims, wherein:
at least one of the sensor array and the electronics structure is powered using at least one of electromagnetic induction, radio frequency induction, and battery power.
15. The prosthesis of any one of the foregoing claims, wherein:
the electronics structure includes a microcontroller and a transmitter.
16. The prosthesis of any one of the foregoing claims, wherein:
the electronics structure includes an application specific integrated circuit, which includes a filter for filtering out low frequency noise.
17. The prosthesis of any one of the foregoing claims, wherein:
the electronics structure includes an application specific integrated circuit, which includes an amplifier for amplifying signals from the sensor array.
18. The prosthesis of any one of the foregoing claims, wherein:
the electronics structure includes an application specific integrated circuit, which includes a multiplexer for multiplexing signals from the sensor array.
19. The prosthesis of any one of the foregoing claims, 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.
20. The prosthesis of any one of the foregoing claims, wherein:
the electronics structure includes an application specific integrated circuit, which includes a processor for processing signals from the sensor array.
21. The prosthesis of any one of the foregoing claims, wherein:
the sensors of the sensor array are operative to sense at least one of pressure and temperature.
22. The prosthesis of any one of the foregoing claims, wherein:
the prosthesis includes a microchannel and a micropump in communication with the microchannel to pump mammalian bodily fluid bathing the joint through the microchannel, where an interior of the microchannel is in communication with at least one of the plurality of sensors.
23. The prosthesis of any one of the foregoing claims, wherein:
the wireless transmission of representative signals is accomplished using a radio frequency transmitter.
24. The prosthesis of any one of the foregoing claims, wherein:
the plurality of sensors are operative to sense pressure changes in three axes of movement.
25. A method of monitoring a prosthetic implant and its host mammalian body, the method comprising the steps of:
implanting a sensor array into the mammalian body, the sensor array accompanying a prosthesis also implanted into the mammalian body;
sensing a condition of at least one of a predetermined component, a predetermined contaminant, and a predetermined property using the sensor array;
generating signals responsive to the sensed condition;
wirelessly transmitting signals to a remote receiver outside of the mammalian body, the transmitted signals being representative of signals generated by the sensor array in response to sensing the condition; and processing the transmitted signals by the remote receiver to generate data representative of the sensed condition.
26. The method of claim 25, wherein:
the sensor array is mounted to the prosthesis; and 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 trail hip replacement acetabular cup insert prosthesis.
27. The method of any one of the foregoing claims, further comprising the step of:
filtering out low frequency noise from the generated signals prior to the wirelessly transmitting step.
28. The method of any one of the foregoing claims, further comprising the step of:
amplifying the generated signals prior to the wirelessly transmitting step.
29. The method of any one of the foregoing claims, further comprising the step of:
multiplexing the generated signals prior to the wirelessly transmitting step.
30. The method of any one of the foregoing claims, further comprising the step of:
converting the generated signals from analog to digital prior to the wirelessly transmitting step.
31. The method of any one of the foregoing claims, further comprising the step of:
processing the generated signals prior to the wirelessly transmitting step.
32. The method of any one of the foregoing claims, wherein:
the step of sensing the condition includes sensing at least one of pressure and temperature.
33. The method of any one of the foregoing claims, wherein:
the step of sensing the condition includes utilizing at least one of a microcantilever and a microcapacitor.
34. The method of any one of the foregoing claims, wherein:
the step of sensing the condition includes sensing for markers of infection.
35. The method of any one of the foregoing claims, wherein:
the step of sensing the condition includes encapsulated sensors responsive to pressure changes.
36. The method of any one of the foregoing claims, wherein:
the step of sensing the condition includes sensors in fluid communication with bodily fluids bathing the prosthesis.
37. The method of any one of the foregoing claims, further comprising:
displaying visual representations of the data generated by or during the processing step; and responding to the displayed visual representations to take appropriate corrective action where applicable.
38. The method of any one of the foregoing claims, wherein:
the step of sensing the condition includes the use of encapsulated sensors responsive to pressure changes.
39. The method of any one of the foregoing claims, wherein:
the step of sensing the condition includes sensing 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.
40. A method of detecting infection within mammalian body, the method comprising the steps of:
implanting a sensor array into the mammalian body, the sensor array accompanying a prosthesis also implanted into the mammalian body;
sensing for a marker representative of infection;

generating signals from the sensor array when the marker representative of infection is sensed;
wirelessly transmitting signals to a remote receiver outside of the mammalian body, the transmitted signals being representative of signals generated by the sensor array in response to sensing the marker; and processing the transmitted signals by the remote receiver to generate data representative of the sensed marker.
41. A method of detecting premature failure of a prosthetic implant in a host mammalian body, the method comprising the steps of:
implanting a sensor array into the mammalian body, the sensor array accompanying a prosthesis also implanted into the mammalian body;
sensing conditions comprising at least one of pressure and constituents of mammalian bodily fluid bathing the prosthesis;
generating signals responsive to the sensed conditions;
wirelessly transmitting signals to a remote receiver outside of the mammalian body, the transmitted signals being representative of signals generated by the sensor array in response to sensing the conditions; and processing the transmitted signals by the remote receiver to generate data representative of the sensed condition.
42. A method of fabricating a prosthesis, the method comprising:
associating a prosthetic component with a fluid conduit adapted to be in fluid communication with a mammalian bodily fluid bathing the prosthetic joint; and orienting a plurality of sensors into fluid communication with the interior of the fluid conduit, where the sensors are operative to detect at least one of a predetermined component, a predetermined contaminant, and a predetermined property.
43. A method of fabricating a sensor array, the method comprising:
mounting a plurality of microcantilevers sensors onto a substrate in a predetermined distribution; and encapsulating the microcantilever sensors.
44. A method of fabricating a sensor array, the method comprising:
fabricating a plurality of capacitive sensors a plurality of microcantilevers sensors onto a substrate in a predetermined distribution; and encapsulating the microcantilever sensors.
45. An external brace for supplementing the support structure of a mammalian body, the device comprising:
an external brace for mounting to the exterior of a mammalian body, the brace including a sensor array mounted thereto; and an electronics structure for receiving data from the sensor array and wirelessly transmitting representative data to a remote receiver.
46. A sensor array comprising:
a first capacitive sensor comprising conductive plates separated by a dielectric material, the capacitive plates of the first capacitive sensor lying along a first X-Y and operative to detect pressure along the X axis;
a second capacitive sensor comprising conductive plates separated from one another, the capacitive plates of the second capacitive sensor lying along the first X-Y
plane and operative to detect pressure along the Y axis; and a third capacitive sensor comprising conductive plates separated from one another, the capacitive plates of the third capacitive sensor lying along the first X-Y
plane and operative to detect pressure along a Z plane orthogonal to the first X-Y
plane.
47. A prosthetic trial implant having a microcantilevered sensor array integral to the prosthetic trial implant and operatively coupled to a transmitter to communicate sensed data to a remote transmitter, where the sensed data is indicative of current conditions of a fluid in communication with at least one sensor of the sensor array.
48. A prosthesis having a microcantilevered sensor array integral to the prosthetic permanent implant and operatively coupled to a transmitter to communicate sensed data to a remote transmitter, the sensor array and transmitter including inductively powered and operative to detect at least one of temperature, pressure, and pH
of a fluid in communication with at least one sensor of the sensor array.
49. A prosthetic implant including a microelectromechanical controller coupled to a microcantilevered sensor array integral to the prosthetic implant and operative to sense environmental conditions relative to the prosthetic implant to detect wear of the prosthetic implant more than three months subsequent to a prosthetic implant surgery and provide data to a remote data receiving device operative to allow a physician to determine whether adjustments and/or surgical repair is warranted.
50. A prosthetic implant comprising:
a prosthetic support structure operative to be mounted to a preexisting support structure of a mammalian body;
a sensor array having a plurality of sensors, where at least one of the sensors is operative to detect at least one of viscosity of the synovial fluid; pH of the synovial fluid; cell count within the synovial fluid; protein within the synovial fluid;
phospholipids within the synovial fluid; hyaluronic acid within the synovial fluid;
leukocytes within the synovial fluid; neutrophils within the synovial fluid;
bacterial deoxyribonucleic acid within the synovial fluid; antibodies within the synovial fluid;
glucose concentration within the synovial fluid; lactate dehydrogenase (LDH) within the synovial fluid; uric acid crystals within the synovial fluid; MMP-9 antigens (gelatinase-B) within the synovial fluid; nerve growth factor within the synovial fluid;
excitatory amino acids (EAA) glutamate and aspartate within the synovial fluid;
insulin-like growth factor I(IGF-I) and its binding proteins (IGFBP) 3 and 4 within the synovial fluid; oxidase activity within the synovial fluid; polyamine oxidases within the synovial fluid; caeruloplasmin (Cp) concentration within the synovial fluid;
beta-glucuronidase content within the synovial fluid; S100A8/A9 within the synovial fluid; C reactive protein within the synovial fluid; rheumatoid factor within the synovial fluid; C3 and C4 within the synovial fluid; metal particulate within the synovial fluid; polyethylene particulate within the synovial fluid; bone particulate within the synovial fluid; cement particulate within the synovial fluid;
osteolytic enzymes within the synovial fluid; genetic markers within the synovial fluid;
antibody markers within the synovial fluid; temperature of the synovial fluid; specific gravity of the synovial fluid; and white cells (and differential cell type) within the synovial fluid; and a transmitter in electrical communication with at least one sensor of the sensor array and operative to transmit data to a remote receive indicative of at least one of viscosity of the synovial fluid; pH of the synovial fluid; cell count within the synovial fluid; protein within the synovial fluid; phospholipids within the synovial fluid;
hyaluronic acid within the synovial fluid; leukocytes within the synovial fluid;
neutrophils within the synovial fluid; bacterial deoxyribonucleic acid within the synovial fluid; antibodies within the synovial fluid; glucose concentration within the synovial fluid; lactate dehydrogenase (LDH) within the synovial fluid; uric acid crystals within the synovial fluid; MMP-9 antigens (gelatinase-B) within the synovial fluid; nerve growth factor within the synovial fluid; excitatory amino acids (EAA) glutamate and aspartate within the synovial fluid; insulin-like growth factor I (IGF-I) and its binding proteins (IGFBP) 3 and 4 within the synovial fluid; oxidase activity within the synovial fluid; polyamine oxidases within the synovial fluid;
caeruloplasmin (Cp) concentration within the synovial fluid; beta-glucuronidase content within the synovial fluid; S100A8/A9 within the synovial fluid; C
reactive protein within the synovial fluid; rheumatoid factor within the synovial fluid; C3 and C4 within the synovial fluid; metal particulate within the synovial fluid;
polyethylene particulate within the synovial fluid; bone particulate within the synovial fluid;
cement particulate within the synovial fluid; osteolytic enzymes within the synovial fluid; genetic markers within the synovial fluid; antibody markers within the synovial fluid; temperature of the synovial fluid; specific gravity of the synovial fluid; and white cells (and differential cell type) within the synovial fluid.
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Effective date: 20200218