Monitorable bone growth stimulator

• US 4,414,979 A
• Filed: 02/23/1981
• Issued: 11/15/1983
• Est. Priority Date: 02/23/1981
• Status: Expired due to Term

• Current Assignee: Electro-Biology Incorporated (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Telectronics Incorporated
• Inventors: Swift, Stephen J., Money, David K., Evans, Robert J., Hirshorn, Michael S.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/237,089
• Time in Patent Office: 995 Days
• Field of Search: 128/419 F, 128/419 PG, 128/419 PT, 128/419 R, 128/419 PS, 128/419 E, 128/903
• US Class Current: 607/51
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/205 for promoting a biological process

Abstract

There is disclosed an implantable bone growth stimulator whose direct-current output can be monitored. Rather than to interrogate the device, e.g., by using a control magnet as in the heart pacer art, the device continuously transmits pulses of electromagnetic energy at a rate proportional to the current being delivered. The continuous transmission expends no more than about five percent of the total power. Instead of using an electrode lead as an antenna for radiating the pulses, a separate coil inside the device is utilized so that the therapeutic current itself is in no way affected by the pulse transmission. Effective transmission is achieved despite the fact that the device is hermetically sealed in a titanium case. Also included is an electronic switch for drastically limiting power drawn from the battery until implantation takes place, in order to provide an extended shelf life.

Claims

1. A monitorable implantable bone growth stimulator comprising an hermetically-sealed metal container and at least one electrode lead exiting therefrom;

said container having therein a power source, circuit means powered by said power source for delivering a constant direct current over said electrode lead to a bone to be stimulated, a transmit-only coil, and means for generating current pulses through said coil at a rate dependent upon the magnitude of said constant direct current for radiating a monitorable signal externally of said container, said circuit means including a current reference and means for delivering a current which is proportional to and dependent upon said current reference, said current pulse generating means operating at a rate which is likewise proportional to and dependent upon said current reference.

2. A monitorable implantable bone growth stimulator in accordance with claim 1 wherein changes in said current reference are primarily dependent on changes in the magnitude of said power source.

3. A monitorable implantable bone growth stimulator in accordance with claim 1 wherein said current pulse generating means operates continuously after implantation.

4. A monitorable implantable bone growth stimulator in accordance with claim 3 wherein said current pulse generating means generates pulses at a rate in the range 1-20 pulses per second.

5. A monitorable implantable bone growth stimulator in accordance with claim 4 wherein the pulse rate is no higher than 3.5 pulses per second.

6. A monitorable implantable bone growth stimulator in accordance with claim 3 wherein said current pulse generating means generates pulses having a duration in the range 50-500 microseconds.

7. A monitorable implantable bone growth stimulator in accordance with claim 1 wherein said current pulse generating means generates pulses at a rate in the range 1-20 pulses per second.

8. A monitorable implantable bone growth stimulator in accordance with claim 2 wherein the pulse rate is no higher than 3.5 pulses per second.

9. A monitorable implantable bone growth stimulator in accordance with claim 1 wherein said current pulse generating means generates pulses having a duration in the range 50-500 microseconds.

10. A monitorable implantable bone growth stimulator in accordance with claim 1 further including means for selectively disabling operation of said current pulse generating means.

11. A monitorable implantable bone growth stimulator in accordance with claim 1 further including automatic means responsive to the absence of current in said electrode lead for causing said circuit means to idle whereby battery life is extended.

12. A monitorable implantable bone growth stimulator in accordance with claim 11 further including means for inhibiting operation of said current pulse generating means when said circuit means is idling.

13. A monitorable implantable bone growth stimulator in accordance with claim 1 wherein said current pulse generating means includes a charge/discharge circuit responsive to high and low threshold voltages, and said high threshold voltage is derived from a pair of P-channel and N-channel transistors having their gates connected together.

14. A monitorable implantable bone growth stimulator comprising a container and at least one electrode lead exiting therefrom;

said container having therein a non-rechargeable power source, circuit means powered by said power source for delivering a constant current over said electrode lead to a bone to be stimulated, and means for generating pulses at a variable rate dependent upon the magnitude of said delivered current to radiate a monitorable signal externally of said container, said circuit means including a current reference and means for delivering a current which is proportional to and dependent upon said current reference, said current pulse generating means operating at a rate which is likewise proportional to and dependent upon said current reference.

15. A monitorable implantable bone growth stimulator in accordance with claim 14 wherein changes in said current reference are primarily dependent on changes in the magnitude of said power source.

16. A monitorable implantable bone growth stimulator in accordance with claim 14 wherein said current pulse generating means operates continuously after implantation.

17. A monitorable implantable bone growth stimulator in accordance with claim 16 wherein said current pulse generating means generates pulses at a rate in the range 1-20 pulses per second.

18. A monitorable implantable bone growth stimulator in accordance with claim 17 wherein the pulse rate is no higher than 3.5 pulses per second.

19. A monitorable implantable bone growth stimulator in accordance with claim 16 wherein said current pulse generating means generates pulses having a duration in the range 50-500 microseconds.

20. A monitorable implantable bone growth stimulator in accordance with claim 14 further including means for selectively disabling operation of said current pulse generating means.

21. A monitorable implantable bone growth stimulator in accordance with claim 14 further including automatic means responsive to the absence of current in said electrode lead for causing said circuit means to idle whereby battery life is extended.

22. A monitorable implantable bone growth stimulator in accordance with claim 21 further including means for inhibiting operation of said current pulse generating means when said circuit means is idling.

23. A monitorable implantable bone growth stimulator in accordance with claim 14 wherein said current pulse generating means includes a charge/discharge circuit responsive to high and low threshold voltages, and said high threshold voltage is derived from a pair of P-channel and N-channel transistors having their gates connected together.