Systems and methods of neuromodulation stimulation for the restoration of sexual function

• US 7,894,913 B2
• Filed: 08/09/2007
• Issued: 02/22/2011
• 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, Thrope, Geoffrey B, Mrva, Joseph J, Strother, Robert B
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Behringer; Luther G
• Application Number:
  US11/891,074
• Publication Number:
  US 20080065167A1
• Time in Patent Office: 1,293 Days
• Field of Search: 607116-119, 607/137
• US Class Current: 607/118
• 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 focused stimulation electrode assembly comprising:

an elongated lead sized and configured to be implanted in tissue,

an electrode array coupled to the lead, the electrode array including at least one conductive element and configured to be implanted in tissue and to apply electrical stimulation to a targeted tissue region, the electrode array including a distal end and a proximal end, and at least one fin, the at least one fin including a first end and a second end, the fin extending axially along the electrode array from the fin first end to the fin second end, the fin comprising a non conductive material to focus the electrical stimulation toward the targeted tissue region and away from a non-targeted tissue region.

2. An assembly according to claim 1, wherein the at least one fin is in a non-contact relationship with the at least one conductive element.

3. An assembly according to claim 1, wherein the at least one fin extends from the electrode array distal end to the electrode array proximal end.

4. An assembly according to claim 1, wherein the at least one fin extends from beyond the electrode array distal end to beyond the electrode array proximal end.

5. An assembly according to claim 1, wherein the at least one fin is flexible.

6. An assembly according to claim 1, wherein the at least one fin is rigid.

7. An assembly according to claim 1, wherein the at least one fin is flexible and a second fin is rigid.

8. An assembly according to claim 1, wherein the at least one fin is deployable between a collapsed condition along the electrode array and an expanded condition extending outward of the electrode array.

9. An assembly according to claim 1, wherein the at least one fin, when in the expanded condition, assumes an open, radially extending configuration that resists proximal passage of the lead through tissue in response to a pulling force that is less than or equal to a threshold axial force level.

10. An assembly according to claim 1, wherein the electrode array is sized and configured to be implanted in a pelvic region.

11. An assembly according to claim 1, wherein the electrode array is adapted to function in a monopolar, bipolar, and/or multi—

polar configuration.

12. An assembly according to claim 1, wherein the targeted tissue region comprises at least one of a target nerve A and a target nerve B.

13. An assembly according to claim 12, 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.

14. An assembly according to claim 12, wherein the electrode array is introduced to at least one of the target nerve A and the target nerve B via the perineum in males and/or females for the restoration of sexual function.

15. An assembly according to claim 12, wherein the electrode array is introduced to at least one of the target nerve A and the target nerve B via the anterior and/or posterior side of the pelvis in males and/or females for the restoration of sexual function.

16. An assembly according to claim 12, wherein the electrical stimulation conveyed to the electrode array affect efferent stimulation of at least one of the target nerve A and the target nerve B, to produce an erection.

17. An assembly according to claim 12, wherein the electrical stimulation conveyed to the electrode array affect afferent stimulation of at least one of the target nerve A and the target nerve B, the afferent stimulation activating central nervous system circuitry that coordinates and/or produces efferent activity in the at least one of the target nerve A and the target nerve B, to produce an erection.

18. An assembly according to claim 1, wherein the non-targeted tissue region is selected from the group consisting of nerves innervating the urethra, anus, colon, rectum, urethral sphincter, anal sphincter, the dorsal genital nerves and/or its roots and/or branches, and the pelvic nerves and/or its roots and/or branches.

19. An assembly according to claim 1, wherein the electrode array is adapted to be tuned to focus the electrical stimulation toward the targeted tissue region and away from the non-targeted tissue region

20. A method of using a focused stimulation electrode assembly comprising:

providing a focused stimulation electrode assembly, the electrode assembly comprising

an elongated lead sized and configured to be implanted in tissue,

an electrode array coupled to the lead, the electrode array including at least one conductive element and configured to be implanted in tissue and to apply electrical stimulation to a targeted tissue region, the electrode array including a distal end and a proximal end, and

at least one fin extending axially along the electrode array and in a non-contact relationship with the at least one conductive element, the fin comprising a non-conductive material to focus the electrical stimulation toward the targeted tissue region and away from a non-targeted tissue region,

implanting the focused stimulation electrode assembly at a targeted tissue region, and

operating the focused stimulation electrode assembly to focus the electrical stimulation toward the targeted tissue region and away from a non-targeted tissue region.

21. The method according to claim 20, wherein the operating step further comprises tuning the electrode array to focus the electrical stimulation toward the targeted tissue region and away from the non-targeted tissue region.