Electrical stimulation adjunct (add-on) therapy for urinary incontinence and urological disorders using an external stimulator

• US 20010002441A1
• Filed: 12/29/2000
• Published: 05/31/2001
• Est. Priority Date: 10/26/1998
• Status: Active Grant

• Current Assignee: Neuro and Cardiac Technologies, LLC
• Original Assignee: Birinder R. Boveja
• Inventors: Boveja, Birinder R.
• Granted Patent: US 6,505,074 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0536 Preventing neurodegenerative response or inflammatory reaction
• 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 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

An apparatus and method for neuromodulation therapy for urinary incontinence and urological disorders comprises an implantable lead-receiver, and an external stimulator having a power source, controlling circuitry, and predetermined programs. The stimulator 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 emits electrical pulses to stimulate the sacral plexus according to a predetermined program. In a second mode of operation, an operator may manually override the predetermined sequence of stimulation.

Claims

1. An apparatus for neuromodulation of the sacral nerves comprising:

a) an implantable lead-receiver comprising a secondary coil and at least one electrode capable of stimulating a sacral nerve;

b) an external stimulator comprising a power source, circuitry to emit electrical signals, at least two predetermined programs to control said electrical signals, and a primary coil;

c) said primary coil of said external stimulator and said secondary coil of said implantable lead-receiver being capable of forming an electrical connection by inductive coupling,

whereby said external stimulator is capable of controlling the stimulation of said sacral nerve.

2. The apparatus of

claim 1

wherein said sacral nerves comprises sacral plexus and its branches.

3. The apparatus of

claim 1

, wherein said external stimulator comprises a patient override mechanism to manually activate said external stimulator.

4. The apparatus of

claim 1

, wherein said predetermined programs are capable of being modified to modify said electrical signals.

5. The apparatus of

claim 1

, further comprising a program selection mechanism wherein said at least two predetermined programs may be selectively operated.

6. The apparatus of

claim 1

, wherein said primary coil of said external stimulator is adapted to be in contact with the skin of the patient.

7. The apparatus of

claim 1

, wherein said lead-receiver comprises a lead body with at least one lumen, a lead body insulation, a conductor, at least one electrode and a coil.

8. The apparatus of

claim 7

, wherein said at least one lumen is selected from the group consisting of single, double, triple and coaxial lumens.

9. The apparatus of

claim 7

wherein said lead body insulation is selected from the group consisting of polyurethane, silicone and silicone with polytetrafluoroethylene.

10. The apparatus of

claim 7

wherein said lead body further comprises a coating selected from the group consisting of lubricious PVP, antimicrobial and anti-inflammatory coatings.

11. The apparatus of

claim 7

wherein said electrode comprises a material selected from the group consisting of platinum, platinum/iridium alloy, platinum/iridium alloy coated with titanium nitride and carbon.

12. The apparatus of

claim 7

wherein said electrode is selected from the group consisting of standard ball electrodes, hydrogel electrodes, and steroid eluting electrodes.

13. The apparatus of

claim 1

, wherein said electrical signals comprise at least one variable component selected from the group consisting of the current amplitude, pulse width, frequency and on-off timing sequence, and said at least two predetermined programs controls said variable component of said electrical signals.

14. The apparatus of

claim 1

, wherein said sacral nerve is stimulated by unipolar stimulation.

15. The apparatus of

claim 1

, wherein said sacral nerve is stimulated by bipolar stimulation.

16. The apparatus of

claim 1

, wherein, at least one of the programs may be locked out to the patient.

17. A method to provide therapy for at least one of urinary incontinence, neurourological disorders, bladder control, bladder inflammation, and bladder pain such as may be caused by Interstitial cystitis disease or the like, comprising the steps of:

a) providing an implantable lead-receiver comprising a secondary coil and at least one electrode to stimulate a sacral nerve;

b) providing an external stimulator comprising circuitry to emit electrical signals, at least two programs to control said electrical signals, an external coil and a power supply;

c) activating one of said at least two programs of said external stimulator to emit said electrical signals to said external coil;

d) inductively transferring said electrical signals from said external coil of said external stimulator to said secondary coil of said lead-receiver;

whereby said electrical signals stimulate said sacral nerve according to at least one of said at least two predetermined programs.

18. The method of

claim 17

, wherein said sacral nerve is the sacral plexus and its branches.

19. The method of

claim 17

, wherein said sacral nerve is stimulated by bipolar stimulation.

20. The method of

claim 17

, wherein said sacral nerve is stimulated by unipolar stimulation.

21. The method of

claim 17

, wherein the step of activating one of said at least two predetermined programs is manually performed.

22. The method of

claim 17

, further comprising manually controlling said electrical signals to stimulate said sacral nerve.

23. The method of

claim 17

, wherein

a) said electrical signals comprise at least one variable component selected from the group consisting of the current amplitude, pulse width, frequency, and on-off timing sequence;

and

b) said at least two predetermined programs controls said variable component of said electrical signals.

24. The method of

claim 17

, further comprising manually disengaging said at least two predetermined programs.

25. The method of

claim 17

, wherein, at least one of the programs may be locked out to the patient.

26. A method for neuromodulating the sacral nerves, comprising:

a) selecting a predetermined program to control the output of an external stimulator;

b) activating said external stimulator to emit electrical signals in accordance with said predetermined program; and

c) inductively coupling said external stimulator with an implantable lead-receiver to stimulate a sacral nerve.

27. The method of

claim 26

, further comprising implanting beneath the skin of a patient said lead-receiver in direct electrical contact with said sacral nerve.