Implantable multichannel stimulator

• US 5,571,148 A
• Filed: 08/10/1994
• Issued: 11/05/1996
• Est. Priority Date: 08/10/1994
• 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.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US08/288,289
• Time in Patent Office: 818 Days
• Field of Search: 607/40-43, 607/46, 607/48, 607/49, 607/55-57, 607/62-65
• US Class Current: 607/57
• CPC Class Codes: A61N 1/36038 Cochlear stimulation
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

A multichannel stimulation system includes a plurality of implantable microminiature stimulators (microstimulators), each being connected to a respective implanted electrode or electrode array. Each microstimulator is selectively operable as controlled by an external (non-implanted) control unit. The electrode or electrode array is implanted so as to contact nerves and/or tissue that is to be stimulated. Operating power is inductively coupled from the control unit to the microstimulators. An information signal is also coupled to the microstimulators to control which of the microstimulators is to be activated to provide a stimulation pulse to its respective electrode. In one embodiment, the invention provides a cochlear prosthesis with an intracochlear electrode array being implanted within the human cochlea, and with selected electrodes of the array being connected to individual ones of the plurality of microstimulators. The control unit of such cochlear prosthesis includes a small external transmitter coil that is worn next to the skin where the microstimulators are implanted. The control unit generates a power signal and an information signal for powering and controlling the cochlear prosthesis.

Claims

1. A multichannel stimulation system comprising:

a plurality of implanted electrodes;

a plurality of implantable microstimulators, each being electrically connected to at least two of said plurality of implanted electrodes, each microstimulator including;

first coupling means for receiving a power signal and an informational signal;

stimulation circuitry powered by said power signal including;

power means for extracting power from said power signal,

demodulator means for recovering and demodulating said information signal,

output circuitry responsive to said information signal for applying a stimulation pulse, derived from the power extracted from said power signal, to said implanted electrodes whenever said information signal contains prescribed stimulator codes,

whereby the stimulation pulse may be selectively applied to the electrodes connected to a respective one of said plurality of microstimulators as controlled by said information signal;

a biocompatible, non-conductive plastic material adapted for binding said plurality of microstimulators together to form a stimulator array; and

an external control unit that includes;

first generating means for generating said power signal,

second generating means for selectively generating said information signal, and

second coupling means for transmitting said power and information signals.

2. The multichannel stimulation system as set forth in claim 1 wherein said external control unit includes modulation means for modulating said power signal with said information signal and wherein said demodulator means of each of said microstimulators includes means for demodulating said power signal to recover said information signal therefrom.

3. The multichannel stimulation system as set forth in claim 1 further including an electrode array comprising said plurality of electrodes spaced apart in a prescribed relationship, each of said plurality of electrodes being connected to at least one of said plurality of implantable microstimulators.

4. The multichannel stimulation system as set forth in claim 3 wherein said plastic material is further adapted for binding said electrode array to said stimulator array.

5. The multichannel stimulation system as set forth in claim 3 wherein said stimulator array includes at least four microstimulators.

6. The multichannel stimulation system as set forth in claim 5 wherein said plastic material that binds together said plurality of microstimulators to form said stimulator array comprises silicone rubber.

7. The multichannel stimulation system as set forth in claim 4 wherein said plastic material that binds together said plurality of microstimulators to form said stimulator array has a sufficient flexibility to allow said stimulator array to bend and flex, thereby allowing said stimulator array to be form fit against a curved surface.

8. The multichannel stimulation system as set forth in claim 4 wherein said first and second coupling means comprise first and second coils, respectively, and wherein said first and second coils are inductively coupled to each other.

9. The multichannel stimulation system as set forth in claim 8 further including:

a formed length of said plastic material which binds said stimulator array, said formed length extending out from and being an integral part of said stimulator array, said formed length further having a distal end; and

a plurality of conductive wires connecting said electrode array to said stimulator array, said conductive wires being sealed within said formed length of said plastic material,

said electrode array including said plurality of electrode contacts that are connected to said plurality of conductive wires proximate said distal end of said formed length.

10. The multichannel stimulation system as set forth in claim 9 wherein said formed length is dimensioned for insertion in the cochlea of a human ear, with said electrode contacts being positioned so as to stimulate an auditory nerve, and with said stimulator array being implanted adjacent to the ear so that the first coil means within each of said microstimulators is oriented to be inductively coupled to the second coil means of the external control unit when said second coil means is positioned so as to be proximate said ear.

11. The multichannel stimulation system as set forth in claim 8 further including an intermediate coil having a focusing coil and a plurality of respective individual coils, said focusing coil being formed within the plastic material of said stimulator array such that the turns of such focusing coil are located near a periphery of such stimulator array, each of said individual coils being wound around a respective one of said microstimulators, and each of said individual coils being connected in circuit relationship with said focusing coil, said first coil being inductively coupled with said focusing coil, and said individual coils being inductively coupled with a respective one of said second coils, whereby said first and second coils are inductively coupled to each other through said intermediate coil.

12. The multichannel stimulation system as set forth in claim 11 wherein said individual coils are connected in series with said focusing coil.

13. The multichannel stimulation system as set forth in claim 11 wherein said individual coils are connected in parallel with said focusing coil.

14. The multichannel stimulation system as set forth in claim 11 wherein a first group of said individual coils are connected in parallel with each other, and a second group of said individual coils are connected in parallel with each other, and wherein said first and second groups of individual coils are connected in series with said focusing coil.

15. The multichannel stimulation system as set forth in claim 4 wherein each of said microstimulators includes a capacitor coupled to the respective electrodes of the microstimulator, and wherein said power means includes means for charging said capacitor with an electrical charge derived from said power signal.

16. The multichannel stimulation system as set forth in claim 15 wherein said demodulator means includes:

memory means for storing prescribed stimulator codes,

comparison means for comparing the recovered information signal with said prescribed stimulator codes and for generating a trigger signal when said recovered information signal bears a prescribed relationship with said prescribed stimulator codes, and

current regulator means controlled by said trigger signal for discharging said capacitor,

whereby the electrical charge on said capacitor may be selectively applied to the respective electrode as controlled by said information signal.

17. The multichannel stimulation system as set forth in claim 1 wherein said external control unit includes a means for receiving a back telemetry signal and each of said microstimulators includes means for sensing a prescribed parameter and means for telemetering said back telemetry signal to said external control unit, said back telemetry signal being derived from said sensed prescribed parameter, whereby said external control unit is provided with information concerning said sensed prescribed parameter.

18. The multichannel stimulation system as set forth in claim 1 wherein each of said microstimulators includes means for sensing a prescribed parameter and said multichannel stimulation system further includes a microtelemeter that is bound to said plurality of microstimulators as part of said stimulator array, said microtelemeter including means for generating a back telemetry signal as a function of said sensed parameters and telemetering said back telemetry signal to said external control unit.

19. An implantable multichannel stimulator comprising:

an electrode array including;

a plurality of electrode contacts,

a plurality of wire connectors, each of said wire connectors electrically connected to one of said electrode contacts,

insulating material disposed within said electrode array such that each of said wire conductors associated with each electrode contact is electrically insulated from the other wire conductors associated with the other electrode contacts; and

a plurality of implantable microstimulators, each of which includes;

a first and second output terminal connected to prescribed selected ones of said wire conductors of said electrode array,

means for applying a stimulation pulse between said first and second output terminals in a controlled manner, and

a bonding material disposed proximate to said plurality of implantable microstimulators such that said plurality of implantable microstimulators are mechanically held together, said bonding material being compatible with and impervious to body fluids;

whereby selected ones of said electrode contacts of said electrode array have said stimulation pulse applied thereto in response to a controlled application of stimulation pluses from at least one of said microstimulators.

20. The implantable multichannel stimulator as set forth in claim 19 wherein each of said plurality of microstimulators further includes:

first coupling means for receiving a power signal and an informational signal;

means for applying a stimulation pulse between said first and second output terminals from power derived from said power signal whenever said informational signal contains a preassigned stimulator code;

whereby a stimulation pulse is selectively applied to the respective electrode as controlled by said informational signal.

21. The implantable multichannel stimulator as set forth in claim 20 wherein said bonding material comprises a plastic material that encapsulates said plurality of microstimulators so as to form a stimulator array, said plastic material imparting a degree of flexibility to said stimulator array that permits said stimulator array to bend and flex so as to allow said stimulator array to be form fit against a curved surface.

22. The implantable multichannel stimulator as set forth in claim 20 wherein said power signal is modulated with said informational signal, and wherein each of said microstimulators includes means for demodulating said power signal to recover said informational signal.

23. The implantable multichannel stimulator as set forth in claim 20 wherein each of said plurality of microstimulators further includes a capacitor coupled to said first and second output terminals, and power supply means for charging said capacitor with an electrical charge derived from said power signal.

24. The implantable multichannel stimulator as set forth in claim 23 wherein each of said microstimulators further includes current regulator means connected to said capacitor for selectively removing any electrical charge on said capacitor.

25. The implantable multichannel stimulator as set forth in claim 24 further including means for generating an initialization signal and wherein said current regulator means is controlled by said initialization signal, said initialization signal being generated whenever said power signal is first received by the microstimulator, whereby any initial charge on said capacitor when power is first applied to said microstimulator is removed, thereby rendering said electrical charge on said capacitor to a known value.

26. The implantable multichannel stimulator as set forth in claim 20 further including a common electrode wherein one of said first or second output terminals from each of said microstimulators is connected to said common electrode, and where the other of said first or second output terminals from each of said microstimulators is connected to one of said electrode contacts of said electrode array, whereby unipolar stimulation occurs between the electrode contacts of said electrode array and said common electrode.

27. The implantable multichannel stimulator as set forth in claim 20 wherein said first and second output terminals from each of said microstimulators are connected to respective ones of said electrode contacts of said electrode array, whereby bipolar stimulation occurs between the electrode contacts of said electrode array connected to the first and second output terminals of each of said microstimulators.

28. The implantable multichannel stimulator as set forth in claim 20 further comprising a common electrode and wherein at least one of said plurality of microstimulators includes means for switching to selectively connect one of said first or second output terminals to said common electrode, whereby unipolar stimulation may be selectively provided.

29. The implantable multichannel stimulator as set forth in claim 28 wherein at least one of the microstimulators is connected to the output terminals of at least another of the microstimulators and includes said switching means to selectively provide a sequence of unipolar stimulation followed by bipolar stimulation.

30. The implanatable multichannel stimulator as set forth in claim 20 wherein the number of microstimulators included within said plurality of microstimulators comprises at least four.

31. The implantable multichannel stimulator as set forth in claim 20 wherein said bonding material is silicon rubber and said at least four microstimulators are bound together by said silicone rubber.

32. The implantable multichannel stimulator as set forth in claim 31 further including:

a formed length of silicon rubber, said formed length extending out from and being an integral part of said silicon rubber bonding material, said formed length further having a distal end;

wherein at least a portion of said wire conductors that connect said electrode contacts of said electrode array to said microstimulators are formed in said length of silicone rubber, said electrode contacts being connected to said plurality of said wire conductors proximate said distal end of said formed length.

33. The implantable multichannel stimulator as set forth in claim 32 wherein said first coupling means comprises a coil included within each one of said microstimulators that is adapted for inductively receiving said power signal.

34. The implantable multichannel stimulator as set forth in claim 33 wherein said formed length is dimensioned for insertion in the cochlea of a human ear, with said electrode contacts being positioned so as to stimulate auditory nerves, and wherein said at least four microstimulators bound by the silicone rubber form an implantable body that may be implanted adjacent the ear so that the coil within each of said microstimulators is oriented to be inductively coupled to the external coil.

35. The implantable multichannel stimulator as set forth in claim 20 wherein said first coupling means comprises a coil included within each one of said microstimulators that is adapted for inductively receiving said power signal.

36. The implantable multichannel stimulator as set forth in claim 35 wherein said coil of each microstimulator is inductively coupled with an external coil through an intermediate coil formed within said electrode array.

37. The implantable multichannel stimulator as set forth in claim 36 wherein said intermediate coil includes a primary winding wrapped around a periphery of said mechanically-held-together microstimulators, and a plurality of secondary windings, each secondary winding wrapped around a periphery of one of said microstimulators.

38. The implantable multichannel stimulator as set forth in claim 37 wherein said secondary windings are connected in series.

39. The implantable multichannel stimulator as set forth in claim 37 wherein said secondary windings are connected in parallel.

40. The implantable multichannel stimulator as set forth in claim 37 wherein a first group of said secondary windings are connected in parallel, and a second group of said secondary windings are connected in parallel, and wherein said first group is connected in series with said second group.

41. The implantable multichannel stimulator as set forth in claim 19 further including;

means for sensing a prescribed parameter, and

a microtelemeter that is mechanically held to the plurality of microstimulators by said bonding material, said microtelemeter including means for generating a back telemetry signal as a function of said sensed parameter and telemetering the back telemetry signal to a location remote from said multichannel stimulator.

42. The implantable multichannel stimulator as set forth in claim 19 wherein each of said plurality of implantable microstimulators includes means for sensing a prescribed parameter and means for telemetering a back telemetry signal, said back telemetry signal being derived from the sensed prescribed parameter.

43. A method of stimulating multiple channels of an implantable electrode array, said electrode array including a plurality of electrode contacts, each being connected to a respective, insulated wire conductor, and an implanted coil in a sealed housing for each stimulation channel that is to be provided, said method comprising the steps of:

(a) inductively coupling said implanted coil with an external coil;

(b) applying an ac power signal to said external coil;

(c) rectifying the ac power signal that is inductively coupled to the implanted coil of each channel;

(d) charging a capacitor within the sealed housing of each channel with the rectified power signal; and

(e) selectively discharging the capacitor of each channel through which stimulation is to be provided through an electrical path that includes a selected one of said wire conductors and the electrode contact connected to said wire conductor.

44. The method as set forth in claim 43 wherein a unique address code is stored in a memory circuit within the sealed housing of each channel, and the method further includes:

modulating the ac power signal applied to the external coil in step (b) with an address word that identifies a particular channel through which stimulation is to be provided;

demodulating the ac power signal received at the implanted coil to recover the address word therefrom;

comparing the recovered address word with the address code stored in the memory circuit of each channel and discharging the capacitor only if the address word is the same as, or bears a prescribed relationship to, the stored address code;

whereby stimulation is selectively provided through multiple channels as a function of the modulation of the ac power signal that is applied to the external coil.

45. A method of stimulating multiple channels of an implantable electrode array, said electrode array including a plurality of microstimulators mechanically held together, each having electrode contacts, each being connected to a respective, insulated wire conductor, said method comprising the steps of:

(a) coupling power to each microstimulator from an external source;

(b) modulating the coupled power with a microstimulator code corresponding to a particular microstimulator of said plurality of microstimulators where a stimulation pulse is to be generated;

(c) demodulating the coupled power at each microstimulator to determine if it contains a preassigned microstimulator code corresponding to the particular microstimulator whereat the demodulation is made; and

(d) generating a stimulation pulse from power derived from said coupled power when the microstimulator code corresponds to the preassigned microstimulator code of the microstimulator whereat the demodulation takes place.

46. The method as set forth in claim 45 further including:

(e) monitoring a prescribed parameter of at least one of said plurality of microstimulators;

(f) generating a back telemetry signal indicative of the monitored prescribed parameter; and

(g) telemetering the back telemetry signal back to the external source.

47. The method as set forth in claim 46 wherein step (e) comprises monitoring the power coupled into each microstimulator from the external source.

48. The method as set forth in claim 46 wherein step (e) further includes monitoring said prescribed parameter, and wherein said prescribed parameter is selected from the group of:

body temperature, body movement, an electromyogram, an electroneurogram, respiration rate, heart rate, glucose level, blood pH, blood oxygen, charge voltage, and a control state of the microstimulator.