Fully implantable neurostimulator for autonomic nerve fiber stimulation as a therapy for urinary and bowel dysfunction

• US 8,214,048 B1
• Filed: 03/10/2006
• Issued: 07/03/2012
• Est. Priority Date: 08/18/2000
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Whitehurst, Todd K., McGivern, James P., Mann, Carla M.
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US11/373,756
• Time in Patent Office: 2,307 Days
• Field of Search: 607/40, 607/41, 600/587
• US Class Current: 607/40
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

An implantable stimulator(s), small enough to be located near or adjacent to an autonomic nerve(s) innervating urinary and/or gastrointestinal structures, uses a power source/storage device, such as a rechargeable battery. Periodic recharging of such a power source/storage device is accomplished, for example, by inductive coupling with an external appliance. The small stimulator provides a means of stimulating a nerve(s) or other tissue when desired, without the need for external appliances during the stimulation session. When necessary, external appliances are used for the transmission of data to and/or from the stimulator(s) and for the transmission of power, if necessary. In a preferred embodiment, the system is capable of open- and closed-loop operation. In closed-loop operation, at least one implant includes at least one sensor, and the sensed condition is used to adjust stimulation parameters.

Claims

1. A method of operating an implantable stimulator to treat a bowel dysfunction characterized by at least one of fecal urgency, fecal frequency, fecal retention and fecal incontinence, the method comprising:

implanting, by injection via a needle or through an incision, at least one implantable stimulator with at least two electrodes adjacent to at least one target nerve comprising at least one of a rectal, inferior hypogastric, prostatic, vesical or uterovaginal nerve plexus;

a thoracic root;

a thoracic spinal nerve;

a lumbar root;

a lumbar spinal nerve;

a hypogastric nerve;

a superior hypogastric nerve plexus;

an inferior hypogastric nerve plexus;

a greater splanchnic nerve;

a lesser splanchnic nerve;

a least splanchnic nerve;

a lumbar splanchnic nerve;

or branches thereof;

providing stimulation parameters to the at least one implantable stimulator;

generating stimulation pulses in accordance with the stimulation parameters; and

delivering the stimulation pulses to the at least one target nerve in order to treat at least one of fecal urgency, fecal frequency, fecal retention and fecal incontinence;

wherein the implantable stimulator has a size and shape suitable for placement adjacent to the at least one target nerve via a needle or cannula.

2. The method of claim 1, wherein the target nerve comprises at least one parasympathetic nerve.

3. The method of claim 2, wherein the parasympathetic nerve comprises one or more of an inferior hypogastric, prostatic, or vesical nerve plexus.

4. The method of claim 1, wherein the target nerve comprises at least one sympathetic nerve.

5. The method of claim 4, wherein the at least one sympathetic nerve comprises one or more of a thoracic root, a thoracic spinal nerve, a lumbar root, a lumbar spinal nerve, the hypogastric nerves, the superior hypogastric plexus, the inferior hypogastric plexus, the greater splanchnic nerve, the lesser splanchnic nerve, the least splanchnic nerve, the lumbar splanchnic nerves, and their branches.

6. The method of claim 1, further comprising:

sensing at least one physical condition of a patient; and

determining the stimulation parameters based upon the at least one sensed physical condition.

7. The method of claim 1, wherein providing stimulation parameters comprises transmitting the stimulation parameters from at least one external appliance.

8. The method of claim 1, wherein the stimulation pulse is an inhibitory stimulation pulse that inhibits parasympathetic or sympathetic input.

9. The method of claim 1, further comprising providing and implanting more than one implantable stimulator, wherein the implantable stimulators operate in a coordinated manner.

10. The method of claim 8, further comprising

generating excitatory stimulation pulses with said at least one stimulator in accordance with the stimulation parameters;

and

delivering the excitatory stimulation pulses to nerves and tissue adjacent to the at least two electrodes in order to treat said bowel dysfunction.

11. The method of claim 8, wherein the inhibitory stimulation pulse inhibits parasympathetic input.

12. The method of claim 1, wherein the stimulation pulse is an excitatory stimulation pulse that increases parasympathetic or sympathetic input.

13. The method of claim 6, wherein sensing at least one physical condition of a patient comprises sensing at least one of colon muscle activity, anal sphincter muscle activity, colon nerve activity, anal sphincter nerve activity, colon pressure or anal sphincter pressure.

14. An implantable stimulator for treating a bowel dysfunction characterized by at least one of fecal urgency, fecal frequency, fecal retention and fecal incontinence, the implantable stimulator comprising:

a housing;

electrical circuitry disposed in the housing for generating stimulation pulses in accordance with programmed stimulation parameters, said stimulation parameters being configured to treat said bowel dysfunction;

at least two electrodes for placement adjacent to at least one target nerve that innervates at least one of a gastrointestinal and a pelvic structure, wherein the at least two electrodes are electrically coupled to the electrical circuitry; and

at least one sensor disposed on the housing and electrically coupled to the electrical circuitry for sensing a physical condition of a patient;

wherein the implantable stimulator has a size and shape suitable for placement adjacent to at least one target nerve via a needle or cannula.

15. The stimulator of claim 14, wherein said electronic circuitry is further configured to receive data on the physical condition of the patient as sensed by the sensor and to adjust said stimulation parameters according to said data on said sensed physical condition.

16. The stimulator of claim 14, wherein said electronic circuitry is further configured to receive said stimulation parameters from at least one external appliance.

17. The stimulator of claim 14, wherein said electronic circuitry is further configured to receive operating power from at least one external appliance.

18. The stimulator of claim 14, wherein said electronic circuitry is further configured to selectively generate excitatory stimulation pulses in accordance with the stimulation parameters and deliver the excitatory stimulation pulses to nerves and tissue adjacent to the at least two electrodes in order to treat said bowel dysfunction.

19. The implantable stimulator of claim 14, wherein the sensor senses at least one of colon muscle activity, anal sphincter muscle activity, colon nerve activity, anal sphincter nerve activity, colon pressure or anal sphincter pressure.

20. A method of operating an implantable stimulator to treat a bowel dysfunction characterized by at least one of fecal urgency, fecal frequency, fecal retention and fecal incontinence, the method comprising:

implanting, by injection via a needle or through an incision, at least one implantable stimulator with at least two electrodes adjacent to at least one target nerve comprising at least one of an inferior hypogastric, prostatic, or vesical nerve plexus;

a thoracic root;

a thoracic spinal nerve;

a lumbar root;

a lumbar spinal nerve;

a hypogastric nerve;

a superior hypogastric nerve plexus;

an inferior hypogastric nerve plexus;

a greater splanchnic nerve;

a lesser splanchnic nerve;

a least splanchnic nerve;

a lumbar splanchnic nerve;

or branches thereof;

providing stimulation parameters to the at least one implantable stimulator;

generating stimulation pulses in accordance with the stimulation parameters; and

delivering the stimulation pulses to the at least one target nerve in order to treat at least one of fecal urgency, fecal frequency, fecal retention and fecal incontinence;

wherein the implantable stimulator has a size and shape suitable for placement adjacent to the at least one target nerve via a needle or cannula.