SYSTEMS AND METHODS OF NEUROMODULATION STIMULATION FOR THE RESTORATION OF SEXUAL FUNCTION

• US 20110144468A1
• Filed: 02/21/2011
• Published: 06/16/2011
• Est. Priority Date: 06/10/2004
• Status: Active Grant

• Current Assignee: Medtronic Urinary Solutions, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Urinary Solutions, Inc. (Medtronic Plc)
• Inventors: Boggs, Joseph W., Strother, Robert B., Mrva, Joseph J., Thrope, Geoffrey B.
• Granted Patent: US 8,805,533 B2
• Time in Patent Office: Days
• US Class Current: 600/373
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2210/1067 Anus
• CPC Class Codes: A61M 2210/1089 Urethra
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0512 Anal electrodes
• CPC Class Codes: A61N 1/0524 Vaginal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007

Abstract

Systems and methods use an external and/or implantable pulse generator system for neuromodulation stimulation to treat sexual dysfunction by the unilateral or bilateral stimulation of a target nerve A and/or a target nerve B using one or more leads and electrodes implanted in tissue in the pelvic region. The electrical stimulation waveform may be conveyed to the target nerve A electrode for a first predetermined amount of time, and conveyed to the target nerve B electrode for a second predetermined amount of time.

Claims

1. A stimulating catheter adapted for use in diagnosing and/or treating a urologic function, the catheter comprising:

an elongated flexible body having a proximal end and a distal end and at least one lumen extending at least a portion of the body,

an inflatable balloon disposed at or near the distal end,

an electrode array disposed along the flexible body, and

an electrical lead coupled to each electrode in the electrode array and extending through the body, the electrical lead adapted for external connection to an electrical source.

2. A catheter according to claim 1:

wherein the electrode array is disposed proximal to the inflatable balloon.

3. A catheter according to claim 1:

wherein the flexible body is adapted to be positioned within the urethra of a male and/or female animal or human.

4. A catheter according to claim 1:

wherein the flexible body is adapted to be positioned within the rectum of a male and/or female animal or human.

5. A catheter according to claim 1:

wherein the flexible body is adapted to be positioned within the vagina of a female animal or human.

6. A catheter according to claim 1:

wherein at least one electrode is positioned on or near the distal tip of the flexible body.

7. A catheter according to claim 1:

wherein the electrode array is coupled to the outside of the flexible body.

8. A catheter according to claim 1:

wherein the flexible body is malleable.

9. A catheter according to claim 1:

wherein the flexible body is adapted to be bendable while positioned within a body cavity, and is adapted to be bendable during removal without causing damage to the body cavity or internal structures.

10. A catheter according to claim 1:

wherein the flexible body is pre-bent in a desired configuration so as to maintain its shape during insertion and stimulation.

11. A catheter according to claim 1:

wherein the electrode array comprises a proximal portion and a distal portion, the electrodes of the proximal portion are spaced apart a first distance, and the electrodes of the distal portion are spaced apart less than the first distance.

12. A catheter according to claim 1:

wherein the electrode array comprises a proximal portion and a distal portion, the electrodes of the proximal portion are spaced about 1 cm to about 5 cm apart, and the electrodes of the distal portion are spaced apart about 0.1 mm to about 2 cm apart.

13. A catheter according to claim 1:

wherein the electrode array comprises a proximal portion and a distal portion, the electrodes of the proximal portion are spaced about 1.5 cm to 2 cm apart, and the electrodes of the distal portion are spaced apart about 0.3 cm to about 0.7 cm apart.

14. A catheter according to claim 1:

wherein the flexible body includes a coude tip at the distal end.

15. A catheter according to claim 1:

wherein the flexible body comprises a multi-lumen body, including at least a first lumen and a second lumen, the first lumen and the second lumen extending at least a portion of the catheter body.

16. A catheter according to claim 15:

wherein the first lumen carries the electrical lead to each electrode in the electrode array.

17. A catheter according to claim 15:

wherein the first lumen is in fluid flow communication with the balloon and serves as a path for fluid flow to fill and drain the balloon.

18. A catheter according to claim 15:

wherein the first lumen carries the electrical lead to each electrode in the electrode array and may be in fluid flow communication with the balloon and may serve as a path for fluid flow to fill and drain the balloon.

19. A catheter according to claim 15:

wherein the second lumen exits the flexible body at or near the distal end and serves as a path for fluid flow to fill and drain the bladder.

20. A catheter according to claim 15:

wherein the flexible body includes a third lumen.

21. A catheter according to claim 20:

wherein the third lumen is in fluid flow communication with the balloon and serves as a path for fluid flow to fill and drain the balloon.

22. A catheter according to claim 1:

wherein the electrode army is adapted to function in a monopolar, bipolar, and/or multi-polar configuration.

23. A catheter according to claim 1:

wherein the electrical stimulation conveyed to the electrode array affect efferent and/or efferent stimulation of at least one of a target nerve A and a target nerve B, to produce an erection.

24. An assembly according to claim 23:

wherein the target nerve A is selected from the group consisting of the cavernous nerve and/or spinal, sacral, lumbar, and/or thoracic roots and/or branches;

the prostatic plexus and/or its spinal, sacral, lumbar, and/or thoracic roots and/or branches;

the pelvic nerve and/or its spinal, sacral, lumbar, and/or thoracic roots and/or branches;

the hypogastric nerve and/or its spinal, sacral, lumbar, and/or thoracic roots and/or branches; and

the splanchnic nerve and/or its spinal, sacral, lumbar, and/or thoracic roots and/or branches, and

wherein the target nerve B is selected from the group consisting of the pudendal nerve and/or its spinal, sacral, lumbar, and/or thoracic roots and/or branches;

the perineal nerve and/or its spinal, sacral, lumbar, and/or thoracic roots and/or branches;

the nerves that innervate the ischiocavernosus, bulbocavernosus, and/or bulbospongiosus muscles and/or their spinal, sacral, lumbar, and/or thoracic roots and/or branches; and

the nerves that innervate the transverse perineal muscles and/or their spinal, sacral, lumbar, and/or thoracic roots and/or branches.

25. A catheter according to claim 1:

wherein the electrical stimulation conveyed to the electrode array affect afferent stimulation of at least one of a target nerve A and a target nerve B, the afferent stimulation activating central nervous system circuitry that coordinates and/or produces efferent activity in at least one of the target nerve A and the target nerve B, to produce an erection.

26. A catheter according to claim 1:

wherein the electrical stimulation conveyed to the electrode array affect afferent stimulation of the dorsal genital nerves and/or its roots and/or its branches, the afferent stimulation activating central nervous system circuitry that coordinates and/or produces efferent activity in at least one of the target nerve A and the target nerve B, to produce an erection.

27. A method of using a stimulating catheter comprising:

providing a stimulating catheter comprising an elongated flexible body having a proximal end and a distal end and at least one lumen extending at least a portion of the flexible body, an inflatable balloon disposed at or near the distal end, an electrode array disposed along the flexible body, and an electrical lead coupled to each electrode in the electrode array and extending through the body, the electrical lead adapted for external connection to an electrical source, inserting the stimulating catheter within one of the urethra and rectum and vagina of an animal or human, inflating the balloon to secure the stimulating catheter in position, and operating the stimulating catheter to convey electrical stimulation waveforms to the electrode array to stimulate at least one of a target nerve and a target muscle.

28. The method according to claim 54:

wherein the target nerve comprises at least one of a target nerve A and a target nerve B.

29. The method according to claim 54:

wherein the electrode array is disposed along the flexible body proximal to the inflatable balloon.