Smart joint implant sensors

• US 10,531,826 B2
• Filed: 11/03/2014
• Issued: 01/14/2020
• 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): Dukert, Brian A
• Application Number:
  US14/530,915
• Publication Number:
  US 20150051455A1
• Time in Patent Office: 1,898 Days
• 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 method of monitoring a prosthetic implant of a mammalian body, the method comprising:

sensing, at a sensor array mounted to a knee replacement tibial tray prosthesis implanted in the mammalian body and including a first sensor and a second sensor, at least a pressure applied to a first articular surface and a second articular surface of the knee replacement tibial tray prosthesis in two dimensions of a plane of the knee replacement tibial tray prosthesis and an axis projecting from the plane, the first articular surface corresponding to a first condyle, the second articular surface corresponding to a second condyle, wherein sensing the pressure comprises;

sensing, by at least the first sensor positioned with respect to the first articular surface, a first portion of the pressure applied to the first articular surface; and

sensing, by at least the second sensor positioned with respect to the second articular surface, a second portion of the pressure applied to the second articular surface;

generating first signals responsive to the sensed pressure applied to the knee replacement tibial tray prosthesis; and

wirelessly transmitting second signals, based on the first signal, to a remote receiver outside of the mammalian body, the wirelessly transmitted second signals conveying data representative of shear in the plane, strain in the plane, pressure along the axis of the plane, and a symmetry of loads on the first articular surface and the second articular surface.

2. The method of claim 1, wherein the prosthetic implant further includes a trial knee replacement femoral prosthesis with another sensor array in condyle portions of the trial knee replacement femoral prosthesis for sensing pressure applied to the condyle portions, wherein the data conveyed by the wirelessly transmitted second signals is further representative of loads on the condyle portions.

3. The method of claim 1, further comprising filtering out low frequency noise from the generated first signals prior to wirelessly transmitting the second signals.

4. The method of claim 1, further comprising amplifying the generated first signals prior to wirelessly transmitting the second signals.

5. The method of claim 1, further comprising multiplexing the generated first signals prior to wirelessly transmitting the second signals.

6. The method of claim 1, further comprising converting the generated first signals from analog to digital prior to wirelessly transmitting the second signals.

7. The method of claim 1, further comprising processing the generated first signals prior to wirelessly transmitting the second signals.

8. The method of claim 1, wherein sensing further includes sensing temperature.

9. The method of claim 1, wherein at least one of a microcantilever and a microcapacitor is used during sensing.

10. The method of claim 1, wherein sensing includes sensing for markers of infection.

11. The method of claim 1, wherein encapsulated sensors responsive to pressure changes are used during sensing.

12. The method of claim 1, wherein sensors in fluid communication with bodily fluids bathing the knee replacement tibial tray prosthesis are used during sensing.

13. The method of claim 1, further comprising:

implanting the sensor array into the mammalian body;

displaying visual representations of the data generated by or during a processing step; and

responding to the displayed visual representations to take corrective action.

14. The method of claim 1, wherein sensing further 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, oxidase concentration, or any combination thereof.

15. The method of claim 1, further comprising processing the data conveyed by the wirelessly transmitted second signals by the remote receiver to generate data representative of the sensed pressure.

16. The method of claim 1, wherein sensing further includes sensing for prosthesis debris, and wherein the data conveyed by the wirelessly transmitted second signals is further representative of wear of the knee replacement tibial tray prosthesis.

17. The method of claim 1, further comprising processing the wirelessly transmitted second signals by the remote receiver to generate a mapping of exerted pressures in the plane of the first articular surface and of the second articular surface.

18. The method of claim 1, where the sensor array comprises a plurality of distributed sensors.

19. The method of claim 1, wherein sensing the pressure applied to the first articular surface and the second articular surface of the knee replacement tibial tray prosthesis in two dimensions of a plane of the knee replacement tibial tray prosthesis and an axis projecting from the plane includes sensing pressure with at least two sensors of the sensor array positioned in a same plane in a tray of the knee replacement tibial tray prosthesis.

20. The method of claim 13, wherein implanting the sensor array into the mammalian body includes implanting the sensor array embedded in a tray of the knee replacement tibial tray prosthesis.