Implantable microstimulator system for producing repeatable patterns of electrical stimulation

• US 6,175,764 B1
• Filed: 01/25/2000
• Issued: 01/16/2001
• Est. Priority Date: 02/20/1996
• Status: Expired due to Term

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Richmond, Frances J. R., Loeb, Gerald E.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/490,921
• Time in Patent Office: 357 Days
• Field of Search: 607/1-3, 607/46, 607/48-52, 607/59-61, 128/899, 600/559, 600/302, 600/377
• US Class Current: 607/3
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Improved implantable microstimulators are covered with a biocompatible polymeric coating in order to provide increased strength to the capsule and to capture fragments of the microstimulator should it become mechanically disrupted. Such coating also makes the microstimulator safer and easier to handle. The coating may include one or more diffusible chemical agents that are released in a controlled manner into the surrounding tissue. The chemical agents, such as trophic factors, antibiotics, hormones, neurotransmitters and other pharmaceutical substances, are selected to produce desired physiological effects, to aid, support or to supplement the effects of the electrical stimulation. Further, microstimulators in accordance with the invention provide systems that prevent and/or treat various disorders associated with prolonged inactivity, confinement or immobilization of one or more muscles. Such disorders include pressure ulcers, venous emboli, autonomic dysreflexia, sensorimotor spasticity and muscle atrophy. The microstimulator systems include external control for controlling the operation of the microstimulators. The control include memory for programming preferred stimulation patterns for later activation by the patient or caregiver.

Claims

1. A system for producing repeatable patterns of electrical stimulation in order to contract one or more muscles, said system comprising:

at least one implantable microstimulator comprising;

a hermetically-sealed housing;

a polymeric coating that covers a substantial portion of said heretically-sealed housing, wherein the polymeric coating includes a chemical agent therein that diffuses from the surface of the polymeric coating into surrounding tissue;

at least two exposed electrodes for providing electrical current, and

electronic means within said hermetically-sealed housing for generating electrical current;

said at least one implantable microstimulator being of a size and shape capable of implantation by expulsion through a hypodermic needle;

at least one control unit with memory means for retaining command information representative of at least one desired pattern of electrical stimulation, said control unit including means for coupling electrical signals to said at least one implantable microstimulator to provide operating power and commands thereto for effectuating said at least one desired pattern of electrical stimulation; and

actuator means within said at least one control unit for sending said operating power and commands to the at least one implantable microstimulator which causes the at least one implantable microstimulator to provide said at least one desired pattern of electrical stimulation.

2. The system of claim 1 wherein said chemical agent is selected to improve the nature of how the at least one implantable microstimulator is received within tissue after the at least one implantable microstimulator is implanted.

3. The system of claim 1 wherein said chemical agent is selected to enhance muscle development within tissue after the at least one implantable microstimulator is implanted.

4. A system for producing repeatable patterns of electrical stimulation in order to contract one or more muscles, said system comprising:

at least one implantable microstimulator comprising;

a hermetically-sealed housing;

a polymeric coating that covers a substantial portion of said heretically-sealed housing, wherein the polymeric coating includes a chemical agent therein that diffuses from the surface of the polymeric coating into surrounding tissue;

at least two exposed electrodes for providing electrical current, and

electronic means within said hermetically-sealed housing for generating electrical current;

said at least one implantable microstimulator being of a size and shape capable of implantation through a cannula;

at least one control unit with memory means for retaining command information representative of at least one desired pattern of electrical stimulation, said control unit including means for coupling electrical signals to said at least one implantable microstimulator to provide operating power and commands thereto for effectuating said at least one desired pattern of electrical stimulation; and

actuator means within said at least one control unit for sending said operating power and commands to the at least one implantable microstimulator which causes the at least one implantable microstimulator to provide said at least one desired pattern of electrical stimulation.

5. The system of claim 4 wherein said chemical agent is selected to improve the nature of how the at least one implantable microstimulator is received within tissue after the at least one implantable microstimulator is implanted.

6. The system of claim 4 wherein said chemical agent is selected to enhance muscle development within tissue after the at least one implantable microstimulator is implanted.