Implantable microdevice with self-attaching electrodes

• US 5,358,514 A
• Filed: 05/17/1993
• Issued: 10/25/1994
• 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: Meadows, Paul, Schulman, Joseph H., Strojnik, Primoz
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US08/062,283
• Time in Patent Office: 526 Days
• Field of Search: 607/60-61, 607/118
• 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: A61N 1/3787 from an external energy source

Abstract

An implantable microminiature stimulator and/or sensor (microdevice) is housed within a sealed housing that includes all the requisite electronic circuitry for inductively receiving power and control signals to sense of biopotential or other biomedical signals and/or to generate electrical stimulation pulse(s) between opposing electrodes. In a preferred embodiment, the housing of the microdevice is tubular, with opposing electrodes extending from each end. The electrodes are self-attaching electrodes that attach to a nerve or muscle without suturing. The electrodes are configured to helically curl around the desired nerve, thereby permitting the microdevice to stimulate the nerve or muscle, or sense signals associated with the nerve or muscle, using a minimal amount of energy. The electrodes and microdevice are sufficiently small to allow attachment to a single nerve, thereby preventing tethering of the nerve or muscle, and to allow their implantation within living tissue through small incisions or puncture holes. The muscle or nerve to which the microdevice is attached may be of any type, e.g., skeletal, smooth or cardiac.

Claims

1. An implantable microstimulator comprising:

an hermetically sealed case wherein electronic stimulation circuitry is housed, said electronic stimulation circuitry including means for inductively receiving power signals and control signals from an external source and means for generating electrical stimulation pulses as a function of said control signals; and

first and second opposing electrodes electrically connected to said electronic stimulation circuitry and extending from said sealed case, said electrical stimulation pulses being electrically applied to said first and second electrodes;

said first and second electrodes having means at distal ends thereof for self-attachment to a nerve;

said microstimulator being adapted for implantation within living tissue with the means for self-attachment of the first and second electrodes being connectable to the same nerve, with said microstimulator interposed therebetween, the microstimulator attached to the nerve thereby floating with the nerve;

whereby tugging or tethering of the nerve is avoided.

2. The implantable microstimulator as set forth in claim 1 wherein said hermetically sealed case is tubular in shape, with said first electrode extending from one end thereof, and with said second electrode extending from the other end thereof.

3. The implantable microstimulator as set forth in claim 1 wherein said hermetically sealed case has a length that is no greater than about 10 mm.

4. The implantable microstimulator as set forth in claim 1 wherein said hermetically sealed case is made from a glass tube having a diameter no greater than about 2 mm.

5. The implantable microstimulator as set forth in claim 1 wherein said means for self-attachment at the distal end of said first and second electrodes comprises a resilient flexible material formed in the shape of a helix adapted to wrap around said nerve.

6. The implantable microstimulator as set forth in claim 5 wherein said flexible material at the distal end of said first and second electrodes comprises an inert metal belonging to a group of biocompatible metals that consists of titanium, iridium and platinum.

7. An implantable microdevice including:

a hermetically-sealed housing having a length of no more than about 10 mm which is inert to body fluids and tissue;

an electronic circuit substantially encapsulated within said hermetically-sealed housing, said electronic circuit including means for generating a stimulation pulse and means for sensing bioelectrical signals;

helically shaped, inert, metallic electrodes hermetically sealed to said housing at or near opposing ends thereof;

a coil within said housing for receiving an alternating magnetic field that provides operating power and control signals for said microdevice;

a capacitor encapsulated within said hermetically-sealed housing for storing power received through said coil;

said electronic circuit including means responsive to said control signals for operating said microdevice as a microstimulator in response to a first control signal, a microsensor in response to a second control signal, and as both a microstimulator and microsensor in response to a third control signal.

8. The microdevice as set forth in claim 7 further including monitoring means within said housing for monitoring the operation of said microdevice and telemetry means within said housing for telemetering a signal representative of said monitored operation to a non-implanted location external to said microdevice.

9. The microdevice as set forth in claim 7 wherein said housing is made from a material belonging to a group consisting of:

glass capillary tubing, ceramic, epoxy and silicon rubber.

10. An implantable microdevice comprising:

a hermetically-sealed housing that is inert to body fluids and tissue, said housing being of a size no greater than 2 mm in diameter and 10 mm in length;

a first electrode comprising an electrically-conductive stem extending into said housing and hermetically sealed to said housing at or near one end thereof, said first electrode further including a first distal end configured for self attachment to a muscle or nerve fiber or a bundle of muscle or nerve fibers;

a second electrode comprising an electrically-conductive stem extending into said housing and hermetically sealed to said housing at or near the other end thereof, said second electrode including a second distal end configured for self attachment to a muscle or nerve fiber or a bundle of muscle or nerve fibers;

a ferrite core encapsulated within said housing having a plurality of turns of a fine, electrically-conductive wire wound therearound, forming a coil;

an electronic circuit encapsulated within said housing and disposed at or near one end of said ferrite core; and

means for electrically connecting said electronic circuit to said coil and said first and second electrodes;

said coil being positioned within said housing to receive an alternating magnetic field, modulated in accordance with information, and

said electronic circuit including means for controlling the microdevice to sense information through the electrodes, to stimulate muscles or nerves through the electrodes, or to both sense and stimulate through the electrodes, as controlled by the information that modulates the alternating magnetic field received by said coil.

11. The implantable microdevice as set forth in claim 10 wherein said first and second distal ends of said first and second electrodes each comprise a helical electrode that is wrapped around said nerve fiber or bundle of nerve fibers, whereby said microdevice attaches to said nerve fiber or bundle of nerve fibers without suturing.

12. The implantable microdevice as set forth in claim 11 wherein at least one of said first or second electrodes, said core, and said coil are radially smaller than, and can pass through, said housing to facilitate assembly of said microdevice.

13. The implantable microdevice as set forth in claim 10 wherein the first and second distal ends of at least one of said first and second electrodes includes a cuff electrode.

14. A method of stimulating a fiber within living tissue using a microdevice, said microdevice having electrical circuitry within a miniaturized hermetically sealed tubular housing, said electrical circuitry being adapted to receive power and control signals from a source external to said microdevice and generate electrical stimulation pulses controlled by said control signals, said electrical stimulation pulses, when generated, being applied between first and second electrodes, each of said first and second electrodes extending from opposite ends of said tubular housing and having attachment means at or near a distal end thereof for securing said electrodes to a fiber within living tissue, said method comprising:

(a) implanting said tubular housing with the electrodes extending from opposite ends thereof within said living tissue;

(b) attaching the distal ends of said electrodes to the fiber within the living tissue; and

(c) controlling said microdevice with said control signals so as to provide electrical stimulation pulses that are applied to the fiber through said electrodes.

15. The stimulation method of claim 14 wherein the attachment means of at least one of said first and second electrodes includes a distal end configured in a helical shape, and wherein the step of attaching the distal end of said at least one electrode to a fiber includes wrapping said helically shaped electrode around said fiber.

16. The stimulation method of claim 15 wherein the attachment means of both said first and second electrodes includes a distal end configured in a helical shape, and wherein the step of attaching the distal end of both of said first and second electrodes to a fiber includes wrapping the respective helically shaped electrode around said fiber.

17. The stimulation method of claim 14 wherein the step of attaching the distal end of at least one electrode to a fiber comprises attaching the distal end of both said first and second electrodes to the same fiber.

18. The stimulation method of claim 14 wherein the step of implanting said housing within said living tissue comprises implanting said tubular housing into the living tissue through the lumen of a needle.

19. The stimulation method of claim 14 further including implanting a plurality of said microdevices, each of said microdevices operating independent of the others, and controlling said plurality of microdevices so as to achieve a coordinated stimulation sequence therebetween.

20. An implantable microdevice of a size capable of insertion through the lumen of a hypodermic needle, said microdevice having a first coil and an electrical circuit, the first coil being positioned within the microdevice so that it may be inductively coupled With a non-implanted. Second coil through which power and control information nay be coupled to the electrical circuit through the first coil, the electrical circuit including means for generating an electrical stimulus, said microdevice having a wire electrode attached thereto through which said electrical stimulus may be delivered, said electrode being configured for attachment to a fiber within living tissue.

21. The implantable microdevice as set forth in claim 20 wherein said electrode comprises a helically formed wire adapted to anchor the microdevice in a given implant location.

22. The implantable microdevice as set forth in claim 21 wherein said electrical circuit further includes means for sensing biopotential signals and neural impulses and wherein said helically formed wire comprises a sensing electrode to sense biopotential signals or neural impulses associated with the fiber to which the electrode is attached.