Bone generating method and device

• US 4,026,304 A
• Filed: 11/06/1974
• Issued: 05/31/1977
• Est. Priority Date: 04/12/1972
• Status: Expired due to Term

• Current Assignee: Valera Pharmaceuticals, Inc. (Endo International PLC)
• Original Assignee: Valera Pharmaceuticals, Inc. (Endo International PLC)
• Inventors: Levy, Didya D.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US05/521,407
• Time in Patent Office: 937 Days
• Field of Search: 128/1 R, 128/82.1, 128/92 C, 128/92 CA, 128/419 F, 128/419 PG, 128/419 R, 128/421, 128/422, 3/1
• US Class Current: 607/51
• CPC Class Codes: A61F 2002/2821 Bone stimulation by electromagnetic fields or electric current for enhancing ossification
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: Y10S 623/919 Bone

Abstract

A method and apparatus for stimulating in vivo bone growth whereby a train of electrical pulses, rather than a direct current potential, is applied to the bone in vivo to produce faster and more satisfactory growth than a direct current voltage. In the embodiment described below, an astable multivibrator producing a pulse train with a duty cycle preferably between 1/10% and 10% is encapsulated in a corrosion resistant material which is, in turn, coated with a non-toxic, non-tissue reactive coating to produce a self-contained prosthetic which will stimulate bone growth.

A second component of this prosthetic system is comprised of a suitable substrate material that can be electrically driven to induce tissue infiltration into the substrate pore structure. This second component of the prosthetic system is not required for the proper functioning of the active component of said prosthetic system but may be used as an adjunct aid if the attending physician so elects. In the embodiment described below, several classes of such materials are discussed. These materials are non-toxic and non-tissue reactive and are of such design as to readily permit tissue infiltration.

Claims

1. A method of stimulating in vivo bone growth comprising the steps of generating a train of electrical pulses of a direct current and applying said train of electrical pulses to a bone within a living vertebrate, said train having a ratio between the time duration of a pulse and the time between adjacent pulses between 1 to 1000 and 1 to 10.

2. A method as in claim 1 wherein said step of generating includes the steps of applying electrical energy to an oscillator circuit having input terminals for receiving said energy and output terminals for said train of electrical pulses and including the further step of placing said oscillator circuit in vivo adjacent the bone to be stimulated.

3. A method as in claim 2 including the further step encapsulating said oscillator circuit with a corrosion resistant material and coating the corrosion resistant material with a non-toxic, non-tissue reactive coating.

4. A method as in claim 3 wherein said coating is chosen from the group consisting of hydrophilic water insoluble polymers of hydroxy lower alkyl acrylates, hydroxy lower alkyl methacrylates, hydroxy lower alkoxy lower alkyl acrylates, hydroxy lower alkoxy lower alkyl methacrylates, vinyl pyrrolidone, lower alkyl substituted acrylamides, lower alkyl substituted methacrylamides, N-hydroxy lower alkyl acrylamides, N-hydroxy lower alkyl methacrylamides, and polyvinyl alcohol.

5. A method, according to claim 4 wherein the polymer is a sparingly cross-linked 2-hydroxyethyl methacrylate polymer.

6. A method as in claim 1 wherein said step of generating includes the step of applying electrical energy to an oscillator circuit mounted exterior to the vertebrate body and including the further step of implanting means for connecting said oscillator circuit to said bone to be stimulated.

7. A method as in claim 1 wherein said pulse train has a firing rate between 0.0005 Hertz and 10K Hertz.

8. A method as in claim 1 wherein said pulse train has a frequency between 0.01 Hz and 1 KHz.

9. A method as in claim 1 wherein said step of generating includes the step of applying a direct current voltage to an astable multivibrator to cause said multivibrator to produce said pulse train.

10. A method as in claim 1 including the further step of implanting a non-toxic substrate adjacent to said bone so that viable bone will form on said substrate.

11. An apparatus for stimulating in vivo bone growth comprising:

means for generating a train of electrical pulses of a direct current, said train having a ratio between the time duration of a pulse and time between adjacent pulses between 1 to 1000 and 1 to 10 and

means for applying said train to a bone within a living vertebrate.

12. An apparatus as in claim 11 wherein said generating means includes an electrical oscillator circuit and said applying means includes a pair of electrodes connected to the output of said oscillator circuit.

13. An apparatus as in claim 12 wherein said oscillator circuit includes an astable multivibrator and means for supplying a direct current voltage to said multivibrator.

14. An apparatus as in claim 12 for stimulating in vivo bone growth further including a layer of corrosion resistant material encapsulating said circuit, and a coating of a non-toxic, non-tissue reactive material about said layer.

15. An apparatus as in claim 14 wherein said electrodes are substantially insulated along their length, exposing portions of the electrodes for applying said pulses to said bone and said electrodes and extend from said circuit through said layer and coating for applying said pulses to a bone.

16. An apparatus as in claim 15 further including a substantially rigid sleeve member about each said electrode.

17. An apparatus as in claim 14 wherein said coating is chosen from the group consisting of hydroxy lower alkyl acrylate, hydroxy lower alkyl methacrylate, hydroxy lower alkoxy lower alkyl acrylate, hydroxy lower alkoxy lower alkyl methacrylate, vinyl pyrrolidone, lower alkyl substituted acrylamides, lower alkyl substituted methacrylamides, N-hydroxy lower alkyl methacrylamides, N-substituted lower alkyl acrylamides, and polyvinyl alcohol.

18. An apparatus for stimulating in vivo bone growth comprising:

an electrical oscillator circuit including means for generating a train of electrical pulses of a direct current having a ratio between the time duration of a pulse and the time between adjacent pulses between 1 to 1000 and 1 to 10, a layer of corrosion resistant material encapsulating said circuit, a coating of a non-toxic, non-tissue reactive material about said layer and a pair of insulated electrodes extending from said circuit through said layer and coating for applying said pulses to a bone.

19. An apparatus as in claim 18 further including a substantially rigid sleeve member about each said electrode.

20. An apparatus as in claim 18 wherein said oscillator circuit includes an astable multivibrator and means for supplying a direct current voltage to said multivibrator.

21. An apparatus as in claim 18 wherein said coating is chosen from the group consisting of polymers of hydroxy lower alkyl acrylates, hydroxy lower alkyl methacrylates, hydroxy lower alkoxy lower alkyl acrylates, hydroxy lower alkoxy lower alkyl methacrylates, vinyl pyrrolidone, lower alkyl substituted acrylamides, lower alkyl substituted methacrylamides, N-hydroxy lower alkyl methacrylamides, N-hydroxy lower alkyl acrylamides, and polyvinyl alcohol.

22. A method of stimulating in vivo bone growth comprising the steps of implanting a non-toxic substrate in the body of a living vertebrate and applying an electrical signal consisting of a train of direct current pulses having a ratio between the time duration of a pulse and the time between adjacent pulses between 1 to 1000 and 1 and 10 to said implanted substrate to cause viable bone to form on said substrate.

23. A method as in claim 22 wherein said step of implanting includes the step of implanting a substrate of hydrophilic material.