Electrical stimulation adjunct (Add-ON) therapy for urinary incontinence and urological disorders using implanted lead stimulus-receiver and an external pulse generator

• US 7,062,330 B1
• Filed: 07/16/2002
• Issued: 06/13/2006
• Est. Priority Date: 10/26/1998
• Status: Expired due to Fees

• Current Assignee: Neuro and Cardiac Technologies, LLC
• Original Assignee: Angely Widhany, Birinder R. Boveja
• Inventors: Widhany, Angely, Boveja, Birinder R.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US10/195,961
• Time in Patent Office: 1,428 Days
• Field of Search: 607 39- 41, 607/118, 607/133, 607/138
• US Class Current: 607/41
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A method and system for neuromodulation therapy for urinary incontinence and urological disorders comprises an implantable lead stimulus-receiver, and an external stimulator-transmitter having a power source, controlling circuitry, and predetermined programs. The stimulator-transmitter further includes a primary coil which inductively transfers electrical signals to the lead-receiver, which is also in electric contact with the sacral nerves. The external stimulator-transmitter emits electrical pulses to stimulate the sacral plexus according to a predetermined program. In one mode of operation, the operator may program one of the predetermined programs, in another mode, the electrical parameters may be “custom” programmed for the patient, and stored in the memory.

Claims

1. A method of delivering electrical pulses to sacral nerves and/or its branches, comprising the steps of:

providing an external pulse generator means for generating and transmitting modulated high frequency pulses, wherein said external pulse generator means comprises a primary coil, power supply, memory, circuitry to emit electrical pulses, and at least two predetermined programs to control said electrical pulses wherein at least one of the programs may be locked out to the patient;

providing an implanted lead stimulus-receiver means for receiving, processing and delivering said pulses to said sacral nerves comprising electrical circuitry, replenishable or rechargeble power source, secondary coil, and at least one electrode adapted to be in contact with said sacral nerves and/or branches;

activating one of said at least two predetermined programs of said external stimulator to emit said electrical pulses to said primary coil; and

inductively transferring said electrical pulses from said primary coil of said external stimulator to said secondary coil of said lead stimulus receiver means;

whereby, said electrical pulses are delivered to said sacral nerves and/or its branches.

2. The method of claim 1 wherein, said pulses are delivered for providing therapy or alleviating the symptoms for at least one of urinary incontinence and urological disorders.

3. The method of claim 1, wherein said electrical pulses have a carrier frequency ranging from 100 Kilo-Hertz to 100 Mega-Hertz.

4. The method of claim 1, wherein electrical pulse frequency delivered to said sacral nerves and/or branches ranges from 5 pulses per second to 500 pulses per second.

5. The method of claim 1, wherein pulse amplitude delivered to said sacral nerves and/or its branches range from 0.1 volts to 10 volts.

6. The method of claim 1, wherein pulse width of said electrical pulses delivered to said sacral nerves and/or its branches range from 20 micro-seconds to 5 milli-seconds.

7. The method of claim 1, wherein said electrical pulses are repeatedly applied to said nerves and/or its branches for applying therapy.

8. The method of claim 1, wherein variable parameters of said electrical pulses are adapted to be capable of being individually adjusted for the required therapy.

9. The method of claim 1, wherein variable parameters of said electrical pulses which are optimized for the patient are adapted to be stored in memory of said external pulse generator.

10. The method of claim 1, wherein said implanted lead stimulus receiver contains an internal power source comprising of replenishable capacative means.

11. The method of claim 1, wherein said implanted lead stimulus receiver contains a battery power source and memory device.

12. The method of claim 1, wherein said sacral nerves and/or its branches are stimulated by bipolar mode of stimulation.

13. The method of claim 1, wherein said sacral nerves and/or its branches are stimulated by unipolar mode of stimulation.

14. The method of claim 1, wherein said external pulse generator-transmitter comprises a telecommunications module.

15. The method of claim 1, wherein said external pulse generator means is adapted to be remotely programmed.

16. The method of claim 1, wherein said external pulse generator means is adapted to be remotely interrogated.

17. A method to selectively stimulate a sacral nerve and/or its branches, comprising the steps of:

providing an external pulse generator-transmitter means comprising circuitry to emit electrical signals, memory, a power supply, at least two predetermined programs, a primary coil, and telecommunications module for remote communication;

providing an implantable stimulus-receiving means comprising a secondary coil, circuitry, replenishable or rechargeable power source, and at least one electrode adapted to be in contact with said sacral nerve and/or its branches;

activating one of said at least two predetermined programs of said external pulse generator-transmitter to emit said electrical signals to said primary coil; and

inductively transferring said electrical signals from said external coil of said external generator to said secondary coil of said stimulus-receiver,

whereby said electrical signals selectively stimulate said sacral nerve and/or its branches.

18. The method of claim 17, wherein said electrical signals emitted by said external pulse generator-transmitter range in frequency from 100 Kilo-Hertz to 100 Mega-Hertz.

19. The method of claim 17, wherein electrical stimulus pulse frequency delivered to said sacral nerve and/or its branches range from 5 pulses per second to 500 pulses per second.

20. The method of claim 17, wherein pulse amplitude delivered to said sacral nerve and/or its branches range from 0.1 volts to 10 volts.

21. The method of claim 17, wherein pulse width delivered to said sacral nerve and/or its branches range from 20 micro-seconds to 5 milli-seconds.

22. A system for providing therapy or alleviating the symptoms of urinary incontinence and urological disorders by providing electrical pulses to a sacral nerve(s) and/or its branches, comprising:

an external pulse generator transmitter for generating and delivering modulated high frequency signals comprising circuitry, power source, primary coil, at least two predetermined programs wherein at least one of the programs is controlled by a patient;

a lead stimulus-receiver adapted to be implanted for receiving, processing, and delivering said electrical pulses to said sacral nerves, comprising circuitry, secondary coil, replenishable or rechargeable power source, and at least one electrode adapted to be in contact with said sacral nerves and/or its branches; and

said primary coil of said external pulse generator and said secondary coil of said implantable lead stimulus-receiver being capable of forming an electrical connection by inductive coupling,

whereby, said electrical therapy is provided.

23. The system of claim 22, wherein said external pulse generator is adapted to provide signals rangeing in frequency from 100 Kilo-Hertz to 100 Mega-Hertz.

24. The system of claim 22, wherein electrical stimulus pulse frequency delivered to said sacral nerves and/or branches is adapted to range between 5 pulses per second to 500 pulses per second.

25. The system of claim 22, wherein pulse amplitude of the pulses delivered to the sacral nerves and/or branches is adapted to range between 0.1 volts to 10 volts.

26. The system of claim 22, wherein pulse width of electrical pulses of said external pulse generator transmitter is adapted to range between 20 micro-seconds to 5 milli-seconds.

27. The system of claim 22, wherein said signals from said external pulse generator transmitter are controlled by one of said at least two predetermined programs.

28. The system of claim 27, wherein at least one of said at least two predetermined programs is/are adapted to be locked out to the patient.

29. The system of claim 22, wherein variable parameters of said electrical pulses are adapted to be individually adjustable for the required therapy.

30. The system of claim 22, wherein said implanted lead stimulus receiver comprises an internal power source which consists of capacitor means.

31. The system of claim 22, wherein said implanted lead stimulus receiver comprises a battery power source and memory device.

32. The system of claim 22, wherein said external pulse generator transmitter further comprises a telecommunications module.

33. The system of claim 22, wherein said external pulse generator transmitter is adapted to be remotely programmable.

34. The system of claim 22, wherein said external pulse generator transmitter is adapted to be remotely interrogated.