Implantable microstimulator

• US 5,324,316 A
• Filed: 03/03/1993
• Issued: 06/28/1994
• 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: Schulman, Joseph H., Loeb, Gerald E., Gord, John C., Strojnik, Primoz
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US08/025,889
• Time in Patent Office: 482 Days
• Field of Search: 128/419 R, 128/421, 128/423, 128/631
• US Class Current: 607/61
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: H01L 2224/45144 Gold (Au) as principal constituent
• CPC Class Codes: H01L 2224/48091 Arched
• CPC Class Codes: H01L 2224/49109 outside the semiconductor or solid-state body
• CPC Class Codes: H01L 2924/00014 the subject-matter covered by the group, the symbol of which is combined with the symbol of this group, being disclosed without further technical details

Abstract

An addressable, implantable microstimulator is 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. Power and information for operating the microstimulator is received through a modulated, alternating magnetic field in which a coil is adapted to function as the secondary winding of a transformer. Electrical energy is stored in capacitor means and is released into the living body by controlled, stimulating pulses which pass through body fluids and tissue between the exposed electrodes of the microstimulator. Detection and decoding means within the microstimulator are provided for controlling the stimulating pulses in accordance with the modulation of the received, alternating magnetic field. Means for controllably recharging the capacitor is provided.

Claims

1. An implantable microstimulator substantially encapsulated within a hermetically-sealed housing which is inert to body fluids, said microstimulator comprising:

a coil within said hermetically-sealed housing adapted to function as the secondary winding of a transformer, said coil adapted to e disposed in a modulated, alternating magnetic field,

at least two exposed electrodes for providing electrical stimulation,

electronic control means,

capacitor means for storing power for said electrical stimulation, and for storing power for said electronic control means,

means for controllably charging said capacitor means from said alternating magnetic field,

said electronic control means controlling discharge of said capacitor means to provide electrical stimulation through said exposed electrodes and an electric path provided by a body wherein said microstimulator is implanted, and

said electronic control means further providing control of at least one of the duration, the current and the shape of stimulus pulses that comprise said electrical stimulation in accordance with the modulation of said alternating magnetic field.

2. The microstimulator recited in claim 1 wherein is included means for controlling said microstimulator in the event of failure to receive sufficient power or invalid modulation, lack of sufficient modulation, and upon startup.

3. The microstimulator recited in claim 1 wherein said capacitor means is charged by a first electrical circuit using the body as part of the charging path and discharged, while said first electrical circuit is broken, by a second electrical circuit connecting said electrodes together inside said microstimulator.

4. The microstimulator recited in claim 1 wherein said means for controllably charging said capacitor means, comprises means for regulating the current flow in charging said capacitor means.

5. The microstimulator recited in claim 4 wherein said means for regulating the current flow, regulates said current flow below that which would stimulate said body area, have adverse effect on said body area and have adverse effect on said electrodes.

6. The microstimulator recited in claim 1 wherein said capacitor means is shunt-regulated at least in part to lower the Q of the power supply in aid of stabilization of said electronic control means.

7. The microstimulator recited in claim 1 wherein is included within said microstimulator, means for controlling the amount of electrical energy stored by said microstimulator.

8. The microstimulator recited in claim 7 wherein said amount of electrical energy stored by said microstimulator is several times the amount of electrical energy required by said microstimulator to stimulate.

9. The microstimulator recited in claim 7 wherein said means for controlling the amount of energy stored by said microstimulator comprises means for dissipating excess energy induced into said microstimulator.

10. The microstimulator recited in claim 9 wherein said means for dissipating excess energy comprises current-sinking means.

11. The microstimulator recited in claim 7 wherein said means for controlling the amount of energy stored by said microstimulator comprises a shunt regulator controlling the charging of said capacitor means.

12. The microstimulator recited in claim 7 wherein said means for controlling the amount of energy stored by said microstimulator comprises means for varying the resonant frequency of the electrical circuit comprising said coil.

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

14. The microstimulator recited in claim 1 wherein is also included means for preventing stimulation pulses upon failure of said microstimulator to receive sufficient induced power, for at least one of, proper stimulating pulses or control information.

15. The microstimulator recited in claim 1 wherein said electronic control means comprises detector means and decoding means receiving information from said modulated, alternating magnetic field, as to one or more of, stimulus pulse duration, stimulus pulse current, stimulus pulse shape and identifying the specific microstimulator, to which said modulated information is sent.

16. The microstimulator recited in claim 15 wherein said decoding means is synchronized with the frequency of said alternating magnetic field.

17. The microstimulator recited in claim 15 wherein said detector means comprises means for obtaining and comparing the short term signal and the long term average of such detected signal and providing the compared signal to said decoding means.

18. The microstimulator recited in claim 15 wherein is included means for providing control of one or more of the duration, the current and the shape of said stimulus pulses in accordance with the output of said detection and decoding means.

19. The microstimulator recited in claim 18 in which said microstimulator comprises means for providing stimulation and recharging in two substantially different ranges of current amplitude.

20. The microstimulator recited in claim 15 wherein is included means for storing the pulse control information received by said microstimulator, and where is included mode control means for controlling the storing of information in said means for storing in accordance with an evaluation of the address and validity of the received information.

21. The microstimulator recited in claim 1 wherein is included means to control said electrodes during the initial charge-up of said capacitor means for storing power and until valid control information is received.

22. The microstimulator recited in claim 1 wherein said microstimulator is of a size approximately 2 mm in diameter and 10 mm in length.

23. The microstimulator recited in claim 1 wherein is included means for controlling the amount of energy induced in said coil.

24. The microstimulator recited in claim 23 wherein said means for controlling energy induced in said coil comprises means for varying the capacitance in circuit with said coil, for detuning said tuned coil from said alternating magnetic field.

25. The microstimulator recited in claim 1 wherein said coil comprises 250 turns of 0.00102" D wire and said coil has a distributed capacitance which provides a resonant frequency of said coil at 2 mHz.

26. An implantable microstimulator substantially encapsulated within a hermetically-sealed housing inert to body fluids, said microstimulator being adapted to electrically stimulate living tissue of a body wherein said microstimulator is implanted, said microstimulator having means for receiving a modulated, alternating magnetic field providing power and information, stimulating circuit means comprising two electrodes and capacitor means for storing received electrical energy, said two electrodes adapted to be disposed in one or more of body tissue and connected in series circuit with said capacitor means for discharging said capacitor at least partially into said fluids and tissue, providing a stimulating pulse thereto, means responsive to modulations of said received energy to control the duration of said stimulating pulses to specific values within predetermined ranges and to control the current amplitude of said stimulating pulses to within specific values within predetermined ranges and means for providing a balancing current flow, between said two electrodes, between said stimulating pulses, in the opposite direction from said stimulating pulses.

27. The microstimulator recited in claim 26, wherein is included means for controlling the shape of said stimulating pulses.

28. The microstimulator recited in claim 27 in which said stimulation pulses are controlled to have either abrupt endings or endings with an exponential tail.

29. The microstimulator recited in claim 26 in which said means for providing a balancing, current flow comprises current-regulating means, preventing excess current flow in the direction opposite to said stimulating pulses.

30. The microstimulator recited in claim 26 in which said balancing, controlled current flow between said two electrodes maintains the voltage on the negative one of said electrodes at a voltage substantially below the potential causing cathodic depositions on said negative electrode.

31. The microstimulator recited in claim 26 in which said means for controlling pulse duration and said means for controlling pulse current each comprise further means for controlling said pulse duration and pulse current to low values as default upon one or more of startup of the system and lack of sufficient modulation information and lack of adequate received energy.

32. The microstimulator recited in claim 26 in which is included means for controlling said microstimulator upon one or more of lack of sufficient modulation of said alternating magnetic field and errors in said modulation.

33. An implantable microstimulator substantially encapsulated within a hermetically-sealed housing which is inert to body fluids, said microstimulator having a coil for receiving an alternating magnetic field, stimulating electrode means at one end and a counter electrode at the other end, capacitor means in circuit with said stimulating electrode means and means for controllably charging said capacitor means from voltage induced in said coil, means for at least partly discharging said capacitor means through said electrode means and said counter electrode into a body wherein said microstimulator is implanted and means for controllably recharging said capacitor means.

34. The microstimulator recited in claim 33 wherein said electrode means comprises a plurality of electrodes and said capacitor means comprises an plurality of capacitors, each disposed in circuit with a respective one of said plurality of electrodes and said means for controllably charging said capacitor means comprises means for individually charging said capacitors.

35. The microstimulator recited in claim 34 wherein said capacitors in circuit with said electrodes may be at least partly discharged, individually.

36. An implantable microstimulator having a housing, said microstimulator having inert, metallic electrode means comprising at least two electrodes electrically connected to the inside of said housing through a hermetic seal, one electrode being disposed at or near one end of said housing and the other electrode at or near the other end of said housing, electronic control circuitry and capacitor means disposed within said housing and connected between one of said electrodes and said electronic control circuitry, induction means comprising a coil for receiving a modulated, alternating magnetic field to provide power and control information for said microstimulator, said electronic control circuitry connected in circuit with said coil and said second electrode and providing control and electrical energy for the charge of said capacitor means and, at least partial discharge, of said capacitor means through said electrode means.

37. The microstimulator recited in claim 36 wherein said first electrode means comprises a plurality of electrodes.

38. The microstimulator recited in claim 37 wherein said capacitor means comprises a capacitor in series with each of said electrodes of said plurality of electrodes of said first electrode means.

39. The microstimulator recited in claim 38 wherein said electronic control circuitry comprises switches and regulator means for controlling the charge and at least partial discharge of electrical energy on said plurality of capacitors.

40. The microstimulator recited in claim 36 wherein said metallic electrode means comprises an iridium electrode disposed at each end of said microstimulator.