Method and system for providing pulsed electrical stimulation to sacral plexus of a patient to provide therapy for urinary incontinence and urological disorders

• US 7,177,703 B2
• Filed: 05/11/2003
• Issued: 02/13/2007
• Est. Priority Date: 05/11/2003
• Status: Expired due to Fees

• Current Assignee: Neuro and Cardiac Technologies, LLC
• Original Assignee: Neuro and Cardiac Technologies, LLC
• Inventors: Widhany, Angely, Boveja, Birinder R.
• Primary Examiner(s): Pezzuto; Robert E.
• Assistant Examiner(s): Heller; Tammie K.
• Application Number:
  US10/436,006
• Publication Number:
  US 20050143783A1
• Time in Patent Office: 1,374 Days
• Field of Search: 607 39- 41, 607/118, 607/133
• US Class Current: 607/118
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

A method and system for providing electrical pulses for neuromodulating sacral nerves of a patient utilizing an implantable stimulator. The implantable stimulator comprising a pulse generator module and a stimulus receiver module for coupling with an external stimulator. Control circuitry ensures selective operation of one pulse generator module. The external stimulator comprises a telemetry module for remotely activating (or de-activating) programs over the internet, to arrive at the optimal program for each patient. Once the optimal “dose” is titrated using the external stimulator, the implanted pulse generator can then be programmed to such parameters. The external stimulator in conjunction with the implanted stimulus receiver can override the implanted pulse generator, to provide extra dose of therapy or to conserve the implanted battery. The external stimulator is also networked to other computers. The external programmer may also comprise a global positioning system (GPS) module for determining patient location.

Claims

1. A method to provide electrical pulses to a sacral plexus of a patient to provide therapy for at least one of urinary incontinence and urological disorders, comprising the steps of:

providing an implanted stimulator, wherein said implanted stimulator comprises a microprocessor based programmable pulse generator module and a stimulus receiver module that receives external stimulus signals and is capable of applying said electrical pulses independently of said pulse generator module;

providing an external programmer for programming said electrical pulses of said implanted stimulator;

providing an external stimulator for inductively coupling to said stimulus receiver module;

providing control circuitry that selectively operates one of said implanted pulse generator module and said stimulus receiver module; and

providing an implanted lead in electrical contact with said implanted stimulator, and at least one electrode adapted to be in contact with said sacral plexus;

whereby said electrical pulses are provided to said sacral plexus of a patient.

2. Method of claim 1, wherein said urinary incontinence and urological disorders further comprises treatment for at least one of urge incontinence, overflow incontinence, stress incontinence, functional incontinence, neuro-urological disorders, bladder control, bladder inflammation, and bladder pain such as may be caused by interstitial cystitis disease or the like.

3. Method of claim 1, wherein said stimulus receiver further comprises a coil and circuitry.

4. Method of claim 1, wherein said external stimulator further comprises telemetry circuitry.

5. Method of claim 1, wherein said external stimulator comprises means for networking with remote computers.

6. Method of claim 1, wherein said external programmer comprises a global positioning system (GPS) module for determining patient location.

7. Method of claim 1, wherein said Implanted pulse generator module further comprises rechargeable power source, and is adapted to be recharged using an external power source.

8. Method of claim 1, wherein said electric pulses provided by said external stimulator and said stimulus receiver overrides said electric pulses provided by said implanted pulse generation module.

29. Method of claim 1, wherein said sacral plexus comprises sacral nerve roots S2, S3, S4 or peripheral branches or parts thereof.

9. A method to stimulate a sacral plexus of a patient using pulsed electrical stimulation to provide therapy for at least one of urinary incontinence and urological disorders, comprising the steps of:

providing an implanted stimulator, wherein said implanted stimulator comprises a microprocessor based programmable pulse generator module and a stimulus receiver module that receives external stimulus signals and is capable of applying said electrical pulses independently of said pulse generator module;

providing an external stimulator with adjustable programs of stimulation for inductively coupling to said implanted stimulus receiver;

providing an external programmer for programming said implanted stimulator;

providing a lead connected with said implanted stimulator, and at least one electrode adapted to be in contact with said sacral plexus;

determining suitable stimulation program for said patient, using said external stimulator; and

programming said implanted stimulator with said suitable stimulation program using said external program,

whereby said pulsed electrical stimulation is delivered to said sacral plexus.

10. Method of claim 9, wherein said urinary incontinence and urological disorders further comprises treatment for at least one of urge incontinence, overflow incontinence, stress incontinence, functional incontinence, neuro-urological disorders, bladder control, bladder inflammation, and bladder pain such as may be caused by interstitial cystitis disease or the like.

11. A method of claim 9, wherein said implanted stimulator further comprises control circuitry that selectively operates one of said implanted pulse generator module and said stimulus receiver module.

12. Method of claim 9, wherein said external stimulator further comprises telemetry circuitry.

13. Method of claim 9, wherein said external stimulator comprises means for networking with remote computers.

14. Method of claim 9, wherein said external programmer means further comprises a global positioning system (GPS) receiver means for patient location.

15. A system to neuromodulate sacral plexus of a patient, comprising:

an implantable stimulator, wherein said implantable stimulator comprising a microprocessor based programmable pulse generator module and a stimulus receiver module that receives external stimulus signals and is capable of applying said electrical pulses independently of said pulse generator module;

an external stimulator to provide stimulation pulses by inductively coupling to said stimulus receiver;

an external programmer for programming said implantable stimulator;

control circuitry to selectively operate one of said implantable pulse generator module and said stimulus receiver module; and

an implantable lead with at least one electrode adapted to be in contact with said sacral plexus.

16. System of claim 15, wherein said external stimulator further comprises telemetry circuitry.

17. System of claim 15, wherein said external stimulator comprises means for networking with remote computers.

18. System of claim 15, wherein said external stimulator comprises a global positioning system (GPS) module for determining patient location.

19. System of claim 15, wherein said implanted pulse generator module further comprises rechargeable power source.

20. System of claim 15, wherein said external stimulator can be utilized to titrate said neuromodulation provided to said sacral plexus.

21. A system for providing pulsed electrical stimulation to sacral nerves of a patient to provide therapy for at least one of urinary incontinence and urological disorders, comprising:

an implantable stimulator, wherein said implantable stimulator comprising a pulse generator module and a stimulus receiver module that receives external stimulus signals and is capable of applying said electrical pulses independently of said pulse generator module, wherein said implantable stimulator is programmable with a magnet;

an external stimulator to provide stimulation pulses by inductively coupling to said stimulus receiver;

control circuitry that selectively operates one of said pulse generator module and said stimulus receiver module; and

an implantable lead with at least one electrode adapted to be in contact with said sacral nerves.

22. System of claim 21, wherein said urinary incontinence and urological disorders further comprises treatment for at least one of urge incontinence, overflow incontinence, stress incontinence, functional incontinence, neuro-urological disorders, bladder control, bladder inflammation, and bladder pain such as may be caused by interstitial cystitis disease or the like.

23. System of claim 21, wherein said external stimulator further comprises telemetry circuitry.

24. System of claim 23, wherein said telemetry circuit communicates over the internet.

25. System of claim 21, wherein said external stimulator is networked with remote computers.

26. System of claim 21, wherein said external stimulator comprises a global positioning system (GPS) module for determining patient location.

27. System of claim 21, wherein said implanted pulse generator further comprises rechargeable power source.

28. A system to provide therapy for at least one of urge incontinence, overflow incontinence, stress incontinence, functional incontinence, neuro-urological disorders, bladder inflammation, and bladder pain such as may be caused by interstitial cystitis disease or the like, comprising:

a programmable implantable stimulator, wherein said implantable stimulator comprises a microprocessor based programmable pulse generator module and a stimulus receiver module that receives external stimulus signals and is capable of applying said electrical pulses independently of said pulse generator module, wherein said implantable stimulator is adopted to be rechargeable with an external power supply;

control circuitry that selectively operates one of said pulse generator module and said stimulus receiver module;

an external power source to recharge said implanted stimulator;

an external programmer to program the electrical pulses of said implanted stimulator; and

an implantable lead connectable to said implantable stimulator with at least one electrode adapted to be in contact with a sacral plexus or branches or parts thereof.