Orthopaedic implant with sensors

• US 8,083,741 B2
• Filed: 06/07/2005
• Issued: 12/27/2011
• Est. Priority Date: 06/07/2004
• Status: Active Grant

• Current Assignee: Synthes USA LLC (Johnson & Johnson)
• Original Assignee: Synthes USA LLC (Johnson & Johnson)
• Inventors: Morgan, Chad, Hall, Harry T. IV, Green, James M., Flexner, Geoffrey, Geltz, Charles E.
• Primary Examiner(s): Barrett, Thomas
• Assistant Examiner(s): ARAJ, MICHAEL J
• Application Number:
  US11/147,750
• Publication Number:
  US 20060052782A1
• Time in Patent Office: 2,394 Days
• Field of Search: 606/53, 606/60, 606 69- 72, 606/76, 606/280
• US Class Current: 606/60
• CPC Class Codes: A61B 17/60 for external osteosynthesis, e.g. distractors, contractors
• CPC Class Codes: A61B 17/64 Devices extending alongside the bones to be positioned
• CPC Class Codes: A61B 17/663 for jaw bones, e.g. subcutaneous distractors with external access periodontal bone regeneration A61C8/0006
• 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 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/7001 Screws or hooks combined with longitudinal elements which do not contact vertebrae A61B17/7058 takes precedence
• CPC Class Codes: A61B 17/7037 wherein pivoting is blocked when the rod is clamped
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/7225 for bone compression
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• 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 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/4504 Bones A61B5/4547 takes precedence
• CPC Class Codes: A61B 5/4839 : combined with drug delivery
• CPC Class Codes: A61B 90/06 : Measuring instruments not otherwise provided for
• 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 2002/2821 : Bone stimulation by electromagnetic fields or electric current for enhancing ossification
• CPC Class Codes: A61F 2002/3067 : for data transfer
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/4666 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2002/4672 : for measuring temperature
• CPC Class Codes: A61F 2250/0002 : for data transfer
• CPC Class Codes: A61F 2310/0097 : Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61N 1/205 : for promoting a biological process

Abstract

The present invention relates to an orthopaedic implant, such as a bone plate, for the fixation of bone where the implant also has at least one microchip and at least one sensor connected to the microchip. The sensor or sensors are configured to receive physical stimulus from a portion of the implant or the patient'"'"'s tissue such as temperature, pressure, and strain. The information received from the sensor or sensors is gathered by the microchip and transmitted to a receiver, such as a personal computer, outside the patient. This information enables doctors to diagnose the useful life of the implant, the load sharing of the bone plate, and possible complications typically associated with orthopaedic implants such as infection, fracture non-union, and fatigue. The implant may also have one or more electrodes located on its surface which emit an electric current to stimulate healing of the broken or fractured bone.

Claims

1. An implant comprising:

a body portion configured to contact patient tissue, the body portion defining a first fixation element receiving hole extending therethrough configured to receive a fixation element for coupling the body portion to a bone;

a microchip; and

a plurality of sensors mounted on the body portion, a first one of the sensors being in contact with a perimeter of the first fixation element receiving hole, the plurality of sensors being connected to said microchip, the first sensor being configured to receive physical stimulus from one of a portion of the implant and patient tissue.

2. The implant of claim 1, wherein the microchip further comprises a data logger.

3. The implant of claim 2, wherein the microchip further comprises a power source.

4. The implant of claim 3, wherein the power source comprises a battery.

5. The implant of claim 1, wherein the implant includes a spinal fixation bone plate.

6. The implant of claim 1, wherein the implant includes a coating.

7. The implant of claim 6, wherein the coating includes a polymer or a porous metal.

8. The implant of claim 7, wherein the coating includes a pharmaceutically active agent.

9. The implant of claim 1, wherein the implant is an intramedullary nail.

10. The implant of claim 1, wherein the implant is a spinal fixation element.

11. The implant of claim 10, wherein the spinal fixation element comprises at least one of a pedicle screw, a spinal fixation plate, a spinal fixation rod and a spinal fixation hook.

12. The implant of claim 1, wherein the first sensor is configured and adapted to receive a strain from at least a portion of the implant.

13. The implant of claim 1 wherein the first sensor is configured and adapted to receive a pressure applied to at least a portion of the implant.

14. The implant of claim 1 wherein the first sensor is configured and adapted to receive a temperature of at least a portion of the implant.

15. The implant of claim 1, wherein the first sensor is configured and adapted to record images.

16. The implant of claim 1, wherein first sensor is configured and adapted to emit an electric current for stimulating bone growth.

17. The implant of claim 1, the patient tissue comprising first and second bone portions of a fracture, the implant further comprising an element configured to apply a micro-motion to the first and second bone portions to facilitate fusion of the first and second fractured bone portions.

18. The implant of claim 1, wherein said implant further comprises a counter for counting a number of loading cycles applied to the implant.

19. The implant of claim 1, further comprising a compartment for storing a therapeutic agent.

20. The implant of claim 19, wherein the therapeutic agent comprises at least one of an antibiotic, a growth factor, a pain medication, a chemotherapeutic agent, and a growth inhibitor.

21. The implant of claim 19, wherein the compartment further comprises an electronically operable cover engageable via an electric signal.

22. The implant of claim 21, wherein the electric signal is one of an externally transmitted control signal and a signal automatically transmitted in response to detection of a predetermined stimulus.

23. The implant of claim 1, wherein the implant is an intervertebral implant.

24. The implant of claim 1, wherein the implant is a distractor.

25. The implant of claim 1, wherein the implant is an external fixation apparatus.

26. The implant of claim 1, wherein the first sensor is located within the first fixation hole.

27. The implant of claim 1, further comprising a second sensor on a bone facing surface of the implant in direct engagement with a bone surface.

28. The implant of claim 1, wherein the first sensor measures a deformation of the body portion.

29. An implant for the fixation of bone, comprising:

a body portion configured to contact bone;

a plurality of holes in the body portion for accepting fasteners;

an onboard microchip including a data logger, signal conditioner, multiplexer, and transmitter; and

a first sensor mounted on the body portion and connected to said microchip, the first sensor being in contact with a perimeter of a first one of the plurality of holes,

wherein the first sensor is configured to receive at least one physical stimulus from a portion of one of the implant and the bone.

30. The implant of claim 29, wherein the implant comprises a bone plate.

31. The implant of claim 29, wherein the implant comprises an intramedullary nail.

32. The implant of claim 29, wherein the implant is a spinal fixation element.

33. The implant of claim 32, wherein the spinal fixation element comprises at least one of a pedicle screw, a spinal fixation plate, a spinal fixation rod and a spinal fixation hook.

34. The implant of claim 29, further comprising a second sensor extending around a periphery of a second one of the holes.

35. The implant of claim 34, wherein one of the first and second sensors is selected from at least one of the group consisting of a pressure transducer, a thermocouple, a strain gauge, a digital imaging element, and a cycle counter.

36. The implant of claim 29, wherein the first sensor measures a deformation of the body portion.