Structure and method of manufacture of an implantable microstimulator

• US 5,193,540 A
• Filed: 12/18/1991
• Issued: 03/16/1993
• Est. Priority Date: 12/18/1991
• Status: Expired due to Term

• Current Assignee: Alfred E. Mann Foundation For Scientific Research
• Original Assignee: Alfred E. Mann Foundation For Scientific Research
• Inventors: Strojnik, Primoz, Schulman, Joseph H., Loeb, Gerald E., Gord, John C.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US07/812,051
• Time in Patent Office: 454 Days
• Field of Search: 128/419 C, 128/419 E, 128/419 F, 128/419 R, 128/420 R, 128/421, 128/422, 128/423 R
• US Class Current: 607/61
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

An implantable microstimulator has a structure which is manufactured to be substantially encapsulated within a hermetically-sealed housing inert to body fluids, and of a size and shape capable of implantation in a living body, by expulsion through a hypodermic needle. The internal structure of the microstimulator comprises a coil adapted to function as the secondary winding of a transformer and receive power and control information. Circuit means, including control electronics, a capacitor and electrodes are provided. The electrodes, which may be made one of iridium and the other of tantalum and placed on opposite ends of the microstimulator, or alternatively, an iridium electrode at each end of the microstimulator, are at least partially exposed and provide electrical, stimulating pulses to the body.

Claims

1. An implantable microstimulator substantially encapsulated within a hermetically-sealed housing which is inert to body fluids, said microstimulator being of a size approximately 2 mm in diameter and 10 mm in length and of longitudinal shape capable of implantation in the immediate vicinity of selected areas of the body by expulsion through a hypodermic needle, a first inert, metallic electrode hermetically sealed to said housing at or near one end thereof and a second inert, metallic electrode hermetically sealed to said housing at or near another end thereof, and a substantial portion of said electrodes being exposed outside said microstimulator so as to provide stimulation pulses, a coil having a multiplicity of turns of a fine, electrically-conductive wire adapted to act as the secondary of a transformer and receive a modulated, alternating magnetic field, said alternating magnetic field providing power for said microstimulator and said modulation providing control information for said microstimulator, capacitor means for storing power received from said magnetic field, electronic circuitry, means for electrically connecting said electronic circuitry in circuit with said coil, said capacitor means and said electrodes.

2. The microstimulator recited in claim 1 wherein said electrodes are both iridium and said capacitor means is in electrical circuit between one of said electrodes and said electronic circuitry.

3. The microstimulator recited in claim 2 wherein said capacitor means comprises a plurality of capacitors at least one of which is between one of said electrodes and said electronic circuitry.

4. The microstimulator recited in claim 1 wherein said coil has approximately 200 or more turns.

5. The microstimulator recited in claim 1 wherein said coil is wound on a low-loss, high permeability core.

6. The microstimulator recited in claim 5 wherein said core has a channel through which one of said electrodes extends and is electrically connected to said electronic circuitry which is disposed at or near the end of the core nearest the other electrode.

7. The microstimulator recited in claim 6 wherein said electrical conductor extending through said core is at least partially embedded in a heat-conductive material disposed within said channel in said core, thereby using said core as a heat sink for said conductor.

8. The microstimulator recited in claim 5 wherein said core has a shelf thereon and a metal plate adhered to said shelf and extending beyond the end thereof, said electronic circuitry being disposed on said metal plate.

9. The microstimulator recited in claim 1, wherein said means connecting said electronic circuitry to one of said electrodes comprises a conductive, metallized pad adhered to said shelf and wherein one of said electrodes is electrically connected to said pad, and wherein said electronic circuitry is disposed in a conductive substrate and said substrate of said electronic circuitry is disposed on said metallized pad, thereby connecting said electrode to said electronic circuitry.

10. The microstimulator recited in claim 1 wherein one or more of said electrodes is an iridium ball having an electrically-conductive stem extending into said housing and hermetically sealed with respect to said housing by fusing at or near the end of said housing, with a substantial portion of said ball exposed to provide electrical stimulation.

11. The microstimulator recited in claim 10 wherein, at least a portion of the exposed portion of said iridium ball is electrochemically-activated, forming a stable oxide coating thereon, whereby the charge-carrying capacity of said ball is substantially increased.

12. The microstimulator recited in claim 1 wherein said electrodes have stems connected thereto and each of said stems is fused to a glass bead which glass beads are, in turn, fused to said housing of said microstimulator to provide a hermetic seal.

13. The microstimulator recited in claim 1 wherein said electrodes are both iridium.

14. The microstimulator recited in claim 1 wherein one or more of said electrodes is an inert, bio-compatible metallic film adhered to said microstimulator.

15. The microstimulator recited in claim 1 wherein is included means for anchoring said microstimulator in place within the body.

16. The microstimulator recited in claim 15 wherein said means for anchoring comprises a resilient skirt having one or more arms which are adapted to be resiliently compressed against the sides of said microstimulator while it is disposed within a hypodermic needle and are adapted to spring away from the body of said microstimulator upon release of said microstimulator within the body.

17. The microstimulator recited in claim 15 wherein said means for anchoring comprises spacing the enlarged end of an electrode on the order of 0.010" from the end of said housing, wherein body tissue fills in said space.

18. The microstimulator recited in claim 1 wherein at least one of said electrodes is disposed on said housing and adapted to be substantially transparent to said varying, electromagnetic field.

19. The combination recited in claim 1 wherein at least one of said electrodes is elongated and extends away from said housing.

20. The microstimulator recited in claim 19 wherein said elongated electrode comprises hook-like means for keeping one or more of said electrode and said microstimulator in place.

21. The microstimulator recited in claim 1 wherein a plurality of elongated electrodes extend from said housing.

22. An implantable microstimulator substantially encapsulated within a hermetically-sealed housing which is inert to body fluids, said microstimulator being of a size approximately 2 mm in diameter and 10 mm in length and of a shape capable of implantation through a hypodermic needle, said microstimulator having a first electrode comprising an iridium ball having an electrically-conductive stem extending into said housing and hermetically sealed to said housing at or near one end thereof and a substantial portion of said ball being exposed outside said microstimulator, and a second electrode comprising an inert, metallic conductor comprising an electrically-conductive stem extending into said housing and hermetically sealed to said housing at or near the other end thereof, said metallic conductor having a substantial portion thereof exposed outside said microstimulator, a ferrite core having approximately 200 or more turns of a fine, electrically-conductive wire wound therearound, forming a coil, electronic circuitry disposed at or near one end of said ferrite core, means connecting said electronic circuitry electrically to said coil and said electrodes, wherein information and power may be received by said coil, inside the body, from an alternating magnetic field, modulated in accordance with information, said field being generated from outside said body, and wherein said electrodes provide electrical stimulation to the body and are adapted to be controlled by said electronic circuitry in accordance with said power and said information.

23. The micostimulator recited in claim 22, wherein said coil has approximately 250 turns of approximately 0.001" D wire.

24. The microstimulator recited in claim 22, wherein said means connecting said coil to said electronic circuitry comprises one or more metallized pads disposed on said ferrite, said coil being electrically connected to said pads and said pads being further connected to said electronic circuitry by electrical conductors.

25. The microstimulator recited in claim 24 wherein said two pads of metal are comprised of metal selected from the group comprising palladium, silver, indium, solder and mixtures thereof, and each end of said coil being electrically connected to a respective pad and a gold wire being bonded to each of said metallized pads and to a respective conductive pad on said electronic circuitry.

26. The microstimulator recited in claim 22, wherein the electrically-conductive stem of said iridium ball extends through said ferrite to said electronics circuitry.

27. The microstimulator recited in claim 22 wherein at least one of said electrodes, said core, and said coil are radially smaller than, and can pass through the inner diameter of said housing, for assembling said microstimulator.

28. The microstimulator recited in claim 22 wherein an inert gas is disposed within said microstimulator.

29. The microstimulator recited in claim 22 wherein said microstimulator is filled with a solid which is an inert material impervious to water.

30. An implantable microstimulator of a size capable of expulsion through the lumen of a hypodermic needle, said microstimulator being substantially encapsulated within a hermetically-sealed housing which is inert to body fluids, inert, metallic electrode means hermetically sealed to said housing at or near each end thereof, electronic control circuitry, capacitor means disposed between a first of said electrode means and said electronic control circuitry, induction means comprising a coil for receiving an alternating magnetic field to provide power for said microstimulator, said electronic control circuitry connected to said coil, said capacitor means and the second of said electrode means.

31. The microstimulator recited in claim 30 in which said first electrode means comprises a plurality of electrodes hermetically sealed to said housing in the other end, electronic control circuitry, said capacitor means being disposed between said plurality of electrodes and said electronic control circuitry, induction means comprising a coil for receiving an alternating magnetic field to provide power for said microstimulator, said electronic control circuitry connected to said coil, said capacitor means and said first electrode.

32. The microstimulator recited in claim 30 wherein said capacitor means comprises an individual capacitor disposed between a respective electrode and said electronic control circuitry.

33. The microstimulator recited in claim 30 in which said electronic control circuitry comprises a single microcircuit chip.

34. The microstimulator recited in claim 30 wherein said housing is comprised of one of the group consisting of glass capillary tubing, a ceramic, epoxy and silicon rubber.

35. The process for manufacturing a microstimulator comprised of a housing of a size approximately 2 mm in outer diameter and 10 mm long, two electrodes and a microminiature electronic control circuit, comprising the steps of winding a coil of approximately 200 or more turns of a fine wire, said coil having a diameter smaller than the inner diameter of said housing, so as to fit inside thereof, electrically connecting said coil and said electrodes to said electronic control circuit, inserting said coil, said electrodes, and said electronic control circuit within said housing, disposing one of said electrodes in each end of said housing, with a substantial portion of each said electrode exposed outside said housing, and hermetically sealing said electrodes to said housing.

36. The process recited in claim 35 wherein the exposed portions of said electrodes are approximately 1 to 1.5 mm in length and width and said electrodes are hermetically sealed with respect to said housing by means of heat fusing.

37. The process recited in claim 36 wherein at least one of said electrodes is iridium and after said fusing, said iridium electrode is activated.

38. The process recited in claim 36 wherein one of said electrodes is tantalum and after said fusing, said tantalum electrode is anodized.

39. The process recited in claim 35 wherein at least one of said electrodes is hermetically sealed with respect to said housing by at least a portion of said electrode being fused to a glass bead and wherein said glass bead is fused to said housing.

40. The process recited in claim 35 wherein one or more of said electrodes is hermetically sealed with respect to said housing by being fused thereto, the fusing of one or more of said electrodes also providing the necessary heat to melt a connecting flux which makes an electrical connection to one or more electrical conductors within said housing.

41. The process recited in claim 35 wherein said coil is wound around a low-loss, high-permeability core formed to provide a shelf upon which said electronic control circuit is mounted.

42. The process recited in claim 41 wherein said core further provides the base upon which a plurality of metal pads are disposed for making electrical connections within said microstimulator.

43. The process for manufacturing a microstimulator comprised of a housing of a size approximately 2 mm in outer diameter and 10 mm long, two electrodes each having an electrically-conductive stem, the process comprising the steps of winding a coil of approximately 200 or more turns of a fine wire, connecting both ends of said coil to provide input to an electronic control circuit, said coil, said electronic control circuit and at least one of said electrodes all having a diameter less than the inner diameter of said housing, disposing an electrode at each end of said coil and electronic control circuit, electrically connecting said electrodes to receive the output of said electronic control circuitry and then inserting said coil, electronic control circuit and electrodes in said housing, and hermetically sealing said electrodes to said housing with a substantial portion of each said electrode exposed outside said housing.

44. The process recited in claim 43 in which said coil is wound around a low-loss, high permeability core having a shelf for carrying said electronic control circuitry and another shelf carrying metallized pads for making electrical connection to said coil, and wherein said core has a channel therethrough through which one of said electrically-conductive stems extends.

45. The process recited in claim 43, wherein is included a low-loss, high-permeability core constructed in two, half-cylindrical parts, one part being a lower part and forming a shelf on which said electronic circuitry is disposed, assembling said microstimulator electrodes and electronic circuitry on the lower part, subsequent placement of the other part on said lower part, winding of said coil on said two parts and completion of the connection of said coil to said electronic circuitry.