Apparatus and method for bone fixation and fusion stimulation

• US 5,330,477 A
• Filed: 01/28/1992
• Issued: 07/19/1994
• Est. Priority Date: 01/28/1992
• Status: Expired due to Fees

• Current Assignee: AMER Technology Limited (AMER International Group Company Limited)
• Original Assignee: AMER Technology Limited (AMER International Group Company Limited)
• Inventors: Crook, David F.
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US07/826,991
• Time in Patent Office: 903 Days
• Field of Search: 606/2, 606/61, 606/77, 606/78, 606/64-71, 623/23, 623/24, 623/16, 623/17, 403/201.1, 600/13, 600/9
• US Class Current: 606/33
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• 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 17/8061 specially adapted for particular bones A61B17/70 and A61B17/74 take precedence
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

Apparatus and a method for promoting the healing of a bone having a fracture site or fusion site is provided. The apparatus includes a brace coupled to the site and adapted for stabilizing the site. Firmly coupled to the brace is an electronic circuit emitting an energy for stimulating the healing of the site, where the brace and the electronic circuit form substantially an integral unit.

Claims

1. Apparatus for stimulating healing of and immobilizing a fracture or a fusion site of a bone, the bone having a bone surface with a bone contour, the apparatus comprising

a substantially rigid plate having a surface for intimately mating with the bone surface;

said surface having a preformed contour that is the inverse image of the bone contour;

fastening means for securing said plate directly to the bone;

an electronic-module housing secured to said plate; and

an electronic module, removably disposed in said housing, having disposed therein an electronic circuit for generating and emitting an energy for stimulating the healing of the site.

2. The apparatus, as set forth in claim 1, wherein said housing defines a cavity adapted for receiving said electronic module.

3. The apparatus, as set forth in claim 2, further comprising a cover plate detachably mounted to said housing and over said cavity for enclosing said cavity.

4. The apparatus, as set forth in claim 1, further comprising a capsule for substantially enclosing and insulating said electronic module.

5. The apparatus, as set forth in claim 4, wherein said housing defines a cavity having a contour substantially matching that of said capsule, said cavity adapted for accommodating said capsule.

6. The apparatus, as set forth in claim 1, further comprising a battery affixed to said plate for supplying power to said electronic module.

7. The apparatus, as set forth in claim 6, wherein said defines a cavity adapted for accommodating said battery.

8. The apparatus, as set forth in claim 7, further comprising a cover plate for enclosing said cavity.

9. The apparatus, as set forth in claim 1, wherein said electronic circuit monitors a characteristic indicative of the progress of the healing of said site.

10. The apparatus, as set forth in claim 1, wherein said electronic circuit monitors a characteristic indicative of the status of the apparatus.

11. The apparatus, as set forth in claim 1, wherein said electronic module further comprises a transmitter for converting data into a radio frequency signal adapted for broadcasting.

12. The apparatus, as set forth in claim 1, wherein said emitted energy is an electric current.

13. The apparatus, as set froth in claim 1, wherein said emitted energy is ultrasound.

14. The apparatus, as set forth in claim 1, further comprising more than one electronic circuit said electronic circuits providing stimulating energy to promote the healing of the site, emitting diagnostic energy into the site, receiving said emitted diagnostic energy, and determining the state of health of the site.

15. The apparatus, as set forth in claim 1, wherein said fastening means comprises a fixation means.

16. The apparatus, as set forth in claim 15, further comprising screws for coupling said fixation means to the bone.

17. The apparatus, as set forth in claim 15, further comprising bolts for coupling said fixation means to the bone.

18. The apparatus, as set forth in claim 15, wherein said fastening means comprises a rod having a hook-like member on each end, said hook-like members adapted for hooking onto designated features of the site to secure said plate thereto.

19. A method for promoting the healing of a fracture or fusion site of a bone having a bone surface with a bone contour, the method comprising the steps of:

providing a substantially rigid plate having a surface with a preformed contour that is the inverse image of the bone contour;

affixing said plate directly to the bone for immobilizing the site such that said surface intimately mates with the bone surface;

removably disposing an electronic module, having an electrode circuit, in a housing attached to said plate; and

generating an energy signal with said electronic circuit to stimulate the healing of the site.

20. The method, as set forth in claim 19, further comprising the step of forming a cavity within said housing for receiving said electronic circuit.

21. The method, as set forth in claim 20, further comprising the step of substantially enclosing said cavity.

22. The method, as set forth in claim 19, further comprising the steps of encapsulating said electronic module and affixing said encapsulated electronic module within said housing.

23. The method, as set forth in claim 22, further comprising the step of providing a cavity having a contour substantially matching that of said capsule.

24. The method, as set forth in claim 19, further comprising the step of supplying power to said electronic circuit with a battery attached to said plate.

25. The method, as set forth in claim 19, further comprising the step of receiving said emitted energy with a receiver disposed within said housing.

26. The method, as set forth in claim 25, wherein said emitted energy receiving step comprises a step of receiving said energy having a characteristic indicative of the amount of healing in the site.

27. The method, as set forth in claim 26, further comprising the step of using a transmitter disposed within said housing for converting said received energy into a radio frequency signal adapted for broadcasting.

28. The method, as set forth in claim 19, wherein said energy emitting step comprises a step of emitting an electromagnetic energy.

29. The method, as set forth in claim 19, wherein said energy emitting step comprises a step of emitting an ultrasonic energy.

30. The method, as set forth in claim 19, further comprising the steps of emitting stimulating energy to promote the healing of the site, and emitting diagnostic energy into the site, receiving said emitted diagnostic energy, and determining the state of health of the site.

31. A method for healing a fracture or fusion site of a bone having a bone surface with a bone contour, the method comprising the steps of:

designing a plurality of electronic circuits adapted to perform a number of functions including emitting a stimulating energy, emitting a diagnostic energy, receiving said diagnostic energy, and broadcasting said received diagnostic energy;

designing a plurality of braces adapted for immobilizing an injured bone and accommodating said electronic circuits;

storing said braces and electronic circuit designs in a components library;

determining the need of a patient and the bone contour of the site;

selecting a brace and electronic circuits from said components library in response to said determination;

designing for said brace a surface having a contour the inverse image of the bone contour;

manufacturing a custom brace having said surface and said electronic circuits in response to said selection; and

installing said custom brace and electronic circuits in said patient such that said surface intimately mates with said bone surface.