Methods for detecting osteolytic conditions in the body

• US 8,095,198 B2
• Filed: 01/31/2006
• Issued: 01/10/2012
• Est. Priority Date: 01/31/2006
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Nycz, Jeffrey H., Donofrio, William T., Drapeau, Susan J J.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): DANEGA, RENEE A
• Application Number:
  US11/344,459
• Publication Number:
  US 20070179568A1
• Time in Patent Office: 2,170 Days
• Field of Search: 607/60, 600/549, 600/587
• US Class Current: 600/348
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• 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 5/6882 Anchoring means
• CPC Class Codes: A61F 2/2803 for mandibular reconstruction temporo-mandibular joints A61F2/3099; bone plates for the jaw A61B17/8071
• CPC Class Codes: A61F 2/32 for the hip
• CPC Class Codes: A61F 2/34 Acetabular cups
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/3804 for elbows
• CPC Class Codes: A61F 2/40 for shoulders
• CPC Class Codes: A61F 2/4202 for ankles
• CPC Class Codes: A61F 2/4261 for wrists
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4609 of acetabular cups
• CPC Class Codes: A61F 2/48 Operating or control means, e.g. from outside the body, control of sphincters
• CPC Class Codes: A61F 2/488 : Means for detecting or monitoring wear
• CPC Class Codes: A61F 2002/30405 : made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30448 : using adhesives
• CPC Class Codes: A61F 2002/30449 : the adhesive being cement
• CPC Class Codes: A61F 2002/3067 : for data transfer
• CPC Class Codes: A61F 2002/3079 : Stepped or enlarged apertures, e.g. having discrete diameter changes
• CPC Class Codes: A61F 2002/3403 : Polar aperture
• CPC Class Codes: A61F 2002/3412 : with pins or protrusions, e.g. non-sharp pins or protrusions projecting from a shell surface
• CPC Class Codes: A61F 2002/3414 : Polar protrusion, e.g. for centering two concentric shells
• CPC Class Codes: A61F 2002/3429 : with an integral peripheral collar or flange, e.g. oriented away from the shell centre line
• CPC Class Codes: A61F 2002/3611 : Heads or epiphyseal parts of femur
• CPC Class Codes: A61F 2002/3625 : Necks
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2250/0002 : for data transfer

Abstract

Methods and systems for detecting a biological response indicative of osteolysis or osteolytic pre-conditions in bone.

Claims

1. A detection system for detecting a condition of a bone comprising:

a sensor capable of operating in vivo to detect a cytokine associated with a condition of a bone and to generate a signal representative of a level of the detected cytokine, the sensor configured to be positioned in direct contact with the bone and extending through and in engagement with an artificial implant, the artificial implant defining an opening such that the sensor extends through the opening and into the bone, the sensor having an outer surface configured to detect the cytokine, the outer surface including a bone engaging portion configured for disposal within the bone and for directly detecting the cytokine in the bone, the bone engaging portion extending from an outer surface of the artificial implant, and the sensor having an implant portion having an end surface being aligned with an inner surface of the artificial implant;

a transmitter operable to receive the signal from the sensor and transmit the signal;

a receiver operable to receive the signal from the transmitter and to enable a human intelligible display representative of the signal;

at least one control sensor capable of operating in vivo at an area remote from the sensor, and operable to detect a condition in a bone at the remote area and to generate a signal representative of the detected condition; and

a signal processor operable to receive and compare signals generated by the sensor and signals generated by the at least one control sensor, and operable to send a signal to the transmitter when a signal received from the sensor deviates from a signal received from the at least one control sensor.

2. The detection system of claim 1 wherein the cytokine detected is present in the bone.

3. The detection system of claim 1 wherein the cytokine detected is adjacent to the bone.

4. The detection system of claim 1 wherein the sensor is operable to detect a cytokine selected from the group consisting of TNF, IL-1, and IL-6.

5. The detection system of claim 1 wherein the signal processor is operable to receive signals from the sensor and to generate a baseline representative of the detected level of cytokine, and to send a signal to the transmitter when a signal received from the sensor deviates from the baseline.

6. The detection system of claim 1 further comprising:

a wireless telemetry circuit configured for transmitting the signal from the transmitter to the receiver.

7. The detection system of claim 1 further comprising:

a power source electrically connected to at least one of the sensor, the transmitter and the receiver.

8. The detection system of claim 1 wherein the receiver comprises:

a signal processor operable to convert the signal to a displayable format and to transmit the converted signal; and

an indicator operable to receive the converted signal and provide a human intelligible display representative of the converted signal.

9. The detection system of claim 1 wherein the receiver comprises:

analysis circuitry operable to compare a signal received from the transmitter to a control, and to generate a signal when the signal received from the transmitter exceeds the control; and

an indicator operable to receive the signal generated by the analysis circuitry and to provide a human intelligible display representative of the signal.

10. The detection system of claim 1 further comprising:

an indicator operable to provide a human intelligible display representative of the signal received by the receiver.

11. The detection system of claim 1 wherein the sensor, the signal processor, and the transmitter are combined into a unitary structure.

12. The detection system of claim 11, wherein the unitary structure is capable of operating entirely in vivo.

13. The detection system of claim 1, wherein at least a portion of the inner surface of the artificial implant has a spherical configuration and the spherical portion is aligned with the end surface of the implant portion.

14. The detection system of claim 1 wherein a second sensor is adjacent the bone.

15. The detection system of claim 1 wherein the artificial implant has a recessed flange portion adapted for engagement with the implant portion of the sensor.

16. The detection system of claim 15, wherein the implant is for use in at least one of an ankle, a knee, a hip, a spine, a shoulder, an elbow, a wrist, and a jaw.

17. The detection system of claim 1 wherein the receiver is capable of operating in vivo.

18. The detection system of claim 1 wherein the receiver is capable of operating ex vivo.

19. A detection system for detecting a condition of a bone comprising:

a sensor located in vivo in direct contact with the bone and operable to detect an analyte associated with the onset of an osteolytic condition in the bone and generate a signal representative of a level of the detected analyte, the sensor having an outer surface configured to detect the analyte, the outer surface including a bone engaging portion configured for disposal within the bone and for directly detecting the analvte in the bone, the bone engaging portion extending from an outer surface of an artificial implant, the artificial implant defining an opening such that the sensor extends through the opening and into the bone, and the sensor having an implant portion being aligned with a spherical inner surface of the artificial implant;

a first signal processor operable to receive a signal from the sensor and to transmit the signal;

a transmitter operable to receive the signal from the first signal processor and to transmit the signal;

a receiver operable to receive the signal from the transmitter and to transmit the signal;

a second signal processor operable to receive the signal from the receiver and to transmit the signal;

an indicator operable to receive the signal from the second signal processor and provide a human intelligible display representative of the signal;

at least one control sensor located in vivo at an area remote from the sensor, and operable to detect a condition in a bone at the remote area and to generate a signal representative of the detected condition; and

analysis circuitry operable to compare a signal received from the transmitter to a control, and to send a signal to the indicator that is either implanted close to the surface of skin or ex vivo so that a signal from the indicator can be observed either through the skin or external to a body of a patient when the signal received from the transmitter exceeds the control;

wherein the first signal processor is operable to receive and compare signals generated by the sensor and signals generated by the at least one control sensor, and to send a signal to the transmitter when a signal received from the sensor deviates from a signal received from the at least one control sensor.

20. The detection system of claim 19, wherein the first signal processor is located in vivo.

21. The detection system of claim 19 wherein the sensor is operable to detect an analyte selected from the group consisting of calcium ions, phosphate ions, and matrix metalloproteinases.

22. The detection system of claim 19 wherein the first signal processor uses the signals received from the sensor to generate a baseline representative of the detected level of analyte, and sends a signal to the transmitter when a signal received from the sensor deviates from the baseline.

23. The detection system of claim 19 wherein the sensor, the first signal processor and the transmitter are combined into a unitary structure.

24. The detection system of claim 19 wherein the receiver, the second signal processor and the indicator are combined into a unitary structure.

25. The detection system of claim 19 wherein the receiver is in vivo.

26. The detection system of claim 19 wherein the receiver is ex vivo.

27. A detection system for detecting a condition of a bone comprising:

an in vivo sensor adapted to detect a cytokine in the bone and generate a signal representative of the detected cytokine, the sensor having an outer surface configured to detect the cytokine, the outer surface including a bone engaging portion configured for disposal within the bone and for directly detecting the cytokine in the bone, the bone engaging portion extending from an outer surface of an artificial implant, the artificial implant defining an opening such that the sensor extends through the opening and into the bone, and the sensor having an implant portion having an end surface being aligned with an inner surface of the artificial implant;

a transmitter operable to receive the signal from the sensor and transmit the signal;

a receiver operable to receive the signal from the transmitter and to enable a human intelligible display representative of the signal;

at least one control sensor located in vivo at an area remote from the sensor, and operable to detect a condition of a bone at the remote area and to generate a signal representative of the detected condition; and

a signal processor operable to receive and compare signals generated by the sensor and signals generated by the at least one control sensor, and operable to send a signal to the transmitter when a signal received from the sensor deviates from a signal received from the at least one control sensor.

28. The detection system of claim 27, wherein the signal processor is located in vivo.

29. The detection system of claim 27, wherein the opening has a recessed flange portion configured to receive the implant portion in a mating engagement such that the end surface of the implant portion is aligned with the inner surface of the artificial implant.

30. The detection system of claim 27, wherein at least a portion of the inner surface of the artificial implant has a spherical configuration and the spherical portion is aligned with the end surface of the implant portion.