Implanted bone stimulator and prosthesis system and method of enhancing bone growth

• US 6,143,035 A
• Filed: 01/28/1999
• Issued: 11/07/2000
• Est. Priority Date: 01/28/1999
• Status: Expired due to Fees

• Current Assignee: Johnson & Johnson Professional Company Incorporated (Johnson & Johnson)
• Original Assignee: DePuy Orthopaedics Incorporated (Johnson & Johnson)
• Inventors: McDowell, Christopher Scott
• Primary Examiner(s): Smith, Jeffrey A.
• Application Number:
  US09/239,497
• Time in Patent Office: 649 Days
• Field of Search: 623/16, 623/18, 623/22, 623/16.11, 623/18.11, 623/22.11, 607/50, 607/51, 607/72, 607/75
• US Class Current: 623/22.11
• 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 17/80 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: A61F 2/30721 Accessories
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2002/2821 Bone stimulation by electromagnetic fields or electric current for enhancing ossification
• CPC Class Codes: A61F 2002/30087 piezoelectric
• CPC Class Codes: A61F 2002/30387 Dovetail connection
• CPC Class Codes: A61F 2002/30738 Sleeves
• CPC Class Codes: A61F 2002/30919 Sleeves
• CPC Class Codes: A61F 2002/3625 Necks
• CPC Class Codes: A61F 2002/3627 with lateral apertures, holes or openings
• CPC Class Codes: A61F 2002/3631 with an integral complete or partial peripheral collar or bearing shoulder at its base
• CPC Class Codes: A61F 2002/365 Connections of heads to necks
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61N 1/205 for promoting a biological process
• 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: A61N 1/378 Electrical supply

Abstract

An implanted piezoelectric module generates charge which may be applied to tissue or used to power or recharge an implanted device such as a pump or pacemaker. In a system for enhanced bone healing or anchoring of an implanted bone prosthesis such as a plate, stem, articulation component or other structural component, the piezoelectric element is coupled to receive mechanical strain from body activity and generates a charge which is applied to enhance bone growth for anchoring the prosthesis. In one embodiment, the piezoelectric element is attached to a prosthetic hip stem on the medial side in a position on the shoulder or neck of the stem to preferentially undergo compressive strain. Preferably the element attaches near the surface and is poled such that its outer surface constitutes a negative electrode that operates to stimulate bone growth across an opposing receiving gap in the proximal femur. In another embodiment, an electrode lead extends distally from the piezoelectric element to apply the generated charge remotely thereto, such as at a prosthetic stem or fracture plate distal to the element itself. The piezo element may be located on a different bone. A metal mesh screen may apply the piezo-generated charge over a region of the bone surface to enhance growth of a thickening body at a desired region, for example at a region typically subject to stress shielding. The piezoelectric element may also be positioned in a region of tensile strain, with its cathodic pole extending to the desired growth gap or intended region of bone accretion. Oppositely poled elements may be positioned on opposing sides of a long bone or prosthesis so that the tensile and compressive stresses in opposed region produce charge of like polarity. Additional circuit elements may be attached to the implanted piezo elements to modulate or condition the charge electromechanically generated by the element and optimize its growth-stimulating effect.

Claims

1. A system for enhanced anchoring of an implanted bone prosthesis of the type wherein the prosthesis comprises a plate, stem, articulation component or other structural component for attaching to the bone at a first location, wherein the system comprises

a generator body including a strain response element formed of piezoelectric material and being configured for implantation at a second location to receive strain and generate charge in response thereto, and

at least one output electrode connected to said generator body, said output electrode extendingto said first location for applying the charge generated by the generator body to said first location as a signal of defined polarity to enhance bone growth in the vicinity of the prosthesis.

2. The system of claim 1, wherein said output electrode is configured to apply said charge at a prosthesis surface adjacent a fitting bone gap.

3. The system of claim 1, further comprising means for attaching the strain responsive element to the prosthesis.

4. The system of claim 3, wherein the output electrode includes an electrode surface in the immediate vicinity of said strain responsive element.

5. The system of claim 3, wherein said output electrode extends remotely from said strain responsive element to apply said signal of defined polarity to a region of bone subject to stress shielding by the prosthesis.

6. The system of claim 1, wherein said strain responsive element is sealed in a flexible body implantable proximate to the prosthesis for applying electricity in the vicinity thereof.

7. The system of claim 1, wherein said strain responsive element is configured to fit against a surface of a prosthesis to develop an electrical signal from strain in the prosthesis.

8. The system of claim 7, wherein said strain responsive element is configured to power an electrical device coupled to said prosthesis.

9. The system of claim 1, further comprising a prosthesis, and wherein said strain responsive element is mounted in a region of high strain of said prosthesis, and applies said generated electrical energy to a bone gap about said prosthesis.

10. The system of claim 9, wherein the prosthesis is a femoral stem and said strain responsive element is positioned on the medial side of the stem to operate under compressive strain.

11. The system of claim 9, wherein the prosthesis is a femoral stem and said strain responsive element is poled and positioned in a region of strain such that a first electrode of the element is predominantly cathodic, and said output electrode couples energy of the first electrode to a region of desired bone stimulation.

12. The system of claim 1, wherein the generator body is adapted to couple to a bone for generating charge responsive to strain in the bone.

13. The system of claim 1, wherein the generator body is a flexible body adapted to couple to soft tissue.

14. An electrical charge generation system for medical use, such system comprising a piezoelectric transducer configured for implantation and strain coupling to tissue within a human body so that the transducer generates charge in response to normal musculoskeletal movement of the body and said transducer applies said generated charge to output electrodes, and means for conditioning charge of said output electrodes for application to an implanted device, wherein said means for conditioning charge conditions the charge to form a signal effective for stimulating bone growth adjacent to the implanted device.

15. The system of claim 14, wherein said means for conditioning charge forms a signal effective for powering the implanted device.

16. The system of claim 15, wherein said means for conditioning charge forms a signal effective for recharging a power cell.

17. A method of enhancing bone growth, such method comprising the steps of

a) configuring a piezoelectric material for

i) implantation in a living body, and

ii) receiving strain form tissue when the body is active such that the material generates charge in response to received strain;

and

b) providing electrodes connected to said material and configured for applying the generated charge remotely to a region along a bone so as to form an electric field between the bone and a bone prosthesis and stimulate growth of bone in said region, and

c) implanting the piezoelectric material such that said electrodes apply said charge to said region whereby strain from body activity stimulates said bone growth.