Method for conditioning pelvic musculature using an implanted microstimulator

• US 6,061,596 A
• Filed: 02/25/1998
• Issued: 05/09/2000
• Est. Priority Date: 11/24/1995
• Status: Expired due to Term

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Loeb, Gerald E., Richmond, Frances J. R.
• Primary Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US09/029,372
• Time in Patent Office: 804 Days
• Field of Search: 607/39-42, 607/48, 607/53-57, 607/59, 607/61, 607/118, 607/138
• US Class Current: 607/41
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• 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 1/3787 from an external energy source

Abstract

A system and method for conditioning pelvic muscle tissue for the purpose of treating urinary incontinence uses one or more tiny implantable stimulators (20)--termed "microstimulators"--implanted in or near certain pelvic structures so as to contact target muscle tissue. The microstimulators (20) are small enough to allow their implantation using a hypodermic needle (104). Once implanted, the microstimulators (20) are controlled using a controller (105, 106) and an appropriate coupling coil (102) that couples modulated radio frequency (RF) power into the microstimulators. A fitting station (110) facilitates adjusting the stimulus pattern and amplitude to best meet the needs of a given patient. Once fitted, electrical stimulation is thus provided to the target tissue in accordance with a specified externally-controlled exercise or other regime.

Claims

1. A method for conditioning pelvic muscle or nerve tissue for the treatment of urinary incontinence comprising:

implanting at least one leadless, tubular-shaped microstimulator (20) so as to be in contact with pelvic muscular or nerve tissue that needs to be stimulated for the treatment of urinary incontinence, said microstimulator including electrical circuitry responsive to an externally applied power and data signal for generating a prescribed pattern of stimulation pulses; and

externally generating the power and data signal and transmitting it to the at least one microstimulator.

2. The method of claim 1 wherein the prescribed pattern of stimulation pulses defined by the applied power and data signal comprises a pattern of stimulation pulses that provides conditioning stimulation of the tissue on a regular, ongoing schedule, thereby allowing continence to occur via a natural voluntary control of the conditioned tissue.

3. A method for conditioning and training pelvic muscle tissue with electrical stimuli in order to treat urinary incontinence comprising:

implanting at least one implantable microstimulator in the patient so that exposed electrodes of the microstimulator are in contact with pelvic muscle or nerve tissue, said at least one microstimulator comprising a tubular case having exposed electrodes, and electrical circuitry hermetically sealed within said case and responsive to an externally applied power and data signal for generating at the exposed electrodes a prescribed pattern of stimulation pulses;

generating the power and data signal using an external control unit, and

transmitting the power and data signal to the at least one implanted microstimulator so that the at least one implanted microstimulator generates the prescribed pattern of stimulation pulses as controlled by the external control unit, and conditions and trains pelvic muscle tissue in order to treat urinary incontinence.

4. The method of claim 3 further including:

coupling a fitting station to the implantable microstimulator through the external control unit, the fitting station having a user interface that allows a user to select different stimulus patterns and stimulus amplitudes;

selecting through the user interface a desired stimulus pattern and stimulus amplitude;

formulating the selected stimulus pattern and stimulus amplitude into appropriate command signals; and

merging the command signals into the power and data signal that is transmitted to the at least one implanted microstimulator.

5. The method of claim 4 further including testing the selected stimulus pattern and stimulus amplitude for a desired result before finally selecting such stimulus pattern and stimulus amplitude for long term use.

6. The method of claim 5 wherein the step of implanting at least one implantable microstimulator comprises implanting at least four implantable microstimulators so that exposed electrodes of each microstimulator are in contact with pelvic muscle or nerve tissue.

7. A method for conditioning muscle or nerve tissue of a patient with electrical stimuli for the purpose of treating urinary incontinence comprising:

implanting a plurality of implantable, tubular-shaped, leadless, microstimulators, into the patient so that each is in contact with target pelvic muscle or nerve tissue;

coupling an external transmitter with the plurality of implantable microstimulators;

selecting a desired pattern of stimulation pulses to be applied to the muscle or nerve tissue;

generating a data signal within the external transmitter that is designed to cause a selected pattern of stimulation pulses to be generated by each of the plurality of microstimulators;

transmitting the data signal to each of the plurality of microstimulators;

receiving the data signal at each of the plurality of microstimulators;

generating stimulation pulses at each of the plurality of implanted microstimulators in response to the received data signal, wherein the stimulation pulses generated by the plurality of microstimulators combine to provide an overall pattern of stimulation pulses as prescribed by the external transmitter.