System and method for electrical stimulation of anorectal structures to treat urinary dysfunction

• US 9,782,583 B2
• Filed: 03/20/2016
• Issued: 10/10/2017
• Est. Priority Date: 02/21/2012
• Status: Active Grant

• Current Assignee: Virender K. Sharma
• Original Assignee: Virender K. Sharma
• Inventors: Sharma, Virender K.
• Primary Examiner(s): Muhmood, Nadia A
• Application Number:
  US15/075,164
• Publication Number:
  US 20160303370A1
• Time in Patent Office: 569 Days
• Field of Search: 607 39, 607 40, 607 41
• 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 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A system and method for treating anorectal and/or genitourinary dysfunction includes implanting, in a minimally invasive manner, an electro-medical device for stimulation of two or more anatomical or histological structures of the anorectal region and/or genitourinary region. Electrodes operably connected to the device are positioned proximate the target anatomical or histological structures. The device provides either the same or different stimulation algorithms to each anatomical or histological structure, which may be the same or different. The varied stimulation parameters, such as pulse width, pulse amplitude, and pulse frequency, are defined such that after an application of the electrical pulses, an abdominal leak pressure, an abdominal leak volume, or a urine volume increases or a number of incontinent episodes or a mean incontinence volume per episode decreases relative to said parameters prior to the application of the electrical pulses.

Claims

1. A device for improving a urinary sphincter function of a patient, comprising:

a first electrode configured to contact a first tissue region, wherein said first tissue region is not in physical contact with an internal urinary sphincter of the patient;

a second electrode configured to contact a second tissue region, wherein said second tissue region not in physical contact with said internal urinary sphincter of the patient, wherein said second tissue region is separate and distinct from the first tissue region;

a waveform generator coupled to the first electrode and second electrode, wherein the waveform generator is configured to generate electrical pulses to the first electrode and second electrode and wherein said electrical pulses comprise a pulse width having a range of 10 μ

sec to 500 msec;

a pulse amplitude of 1 μ

Amp to 100 mAmp; and

a pulse frequency of 1 cpm to 100 Hz; and

wherein said pulse width, pulse amplitude, pulse frequency and duty cycle for the electrical pulses transmitted to the first electrode and second electrode are defined such that, after an application of said electrical pulses, an abdominal leak pressure increases by at least five percent relative to an abdominal leak pressure prior to said application of said electrical pulses or such that, after an application of said electrical pulses, an abdominal leak volume increases by at least five percent relative to an abdominal leak volume prior to said application of said electrical pulses.

2. The device of claim 1 wherein the first tissue region comprises at least one of a longitudinal muscle of a rectum, a circular muscle of the rectum, a muscularis mucosa of the rectum, a submucosa of the rectum, a pudendal nerve or a branch of the pudendal nerve, a conjoined longitudinal muscle, a superficial or deep parts of an external anal sphincter, an internal anal sphincter, a muscularis mucosa of an anal canal, a subserosal plexus, a longitudinal intramuscular plexus, a circular intramuscular plexus, a periglandular plexus, a myenteric (Auerbach'"'"'s) plexus, a submucosal (Meissner'"'"'s) plexus of an anorectum, vaginal tissue, and perineal tissue.

3. The device of claim 2 wherein the second tissue region comprises at least one of a longitudinal muscle of a rectum, a circular muscle of the rectum, a muscularis mucosa of the rectum, a submucosa of the rectum, a pudendal nerve or a branch of the pudendal nerve, a conjoined longitudinal muscle, a superficial or deep parts of an external anal sphincter, an internal anal sphincter, a muscularis mucosa of an anal canal, a subserosal plexus, a longitudinal intramuscular plexus, a circular intramuscular plexus, a periglandular plexus, a myenteric (Auerbach'"'"'s) plexus, a submucosal (Meissner'"'"'s) plexus of an anorectum, vaginal tissue, and perineal tissue.

4. The device of claim 1, wherein the electrical pulses transmitted to the first electrode have a different pulse width, pulse amplitude, or pulse frequency than the electrical pulses transmitted to the second electrode.

5. The device of claim 1, wherein the electrical pulses transmitted to the first electrode have a pulse width, a pulse amplitude, and a pulse frequency that is equal to a pulse width, a pulse amplitude, and a pulse frequency of the electrical pulses transmitted to the second electrode.

6. The device of claim 1 further comprising at least one sensor configured to obtain data, wherein said waveform generator is configured to use said data to modify at least one of the electrical pulses transmitted to the first electrode and the electrical pulses transmitted to the second electrode.

7. The device of claim 6, wherein said at least one sensor comprises a pressure sensor, an electrical activity sensor, an impedance sensor, an accelerometer, or an inclinometer.

8. The device of claim 1 further comprising a controller adapted to modify at least one of the electrical pulses transmitted to the first electrode and the electrical pulses transmitted to the second electrode based upon an input from said patient.

9. The device of claim 1 further comprising a transceiver for receiving and transmitting data and/or power from outside the patient'"'"'s body through inductive, radiofrequency (RF), electrical, magnetic, optical or other electromagnetic coupling.

10. The device of claim 1 further comprising an integrated circuit (IC) chip for decoding and storing a plurality of stimulation parameters and generating said electrical pulses and a programmable memory for storing data and stimulation parameters.

11. The device of claim 1, wherein the first electrode is at least 1 cm away from the internal urinary sphincter of the patient.

12. The device of claim 11, wherein the second electrode is at least 1 cm away from the internal urinary sphincter of the patient.

13. A device for improving a urinary sphincter function of a patient, comprising:

a first electrode configured to contact a first tissue region, wherein said first tissue region is at least 1 cm away from an internal urinary sphincter;

a second electrode configured to contact a second tissue region, wherein said second tissue region is at least 1 cm away from the internal urinary sphincter, wherein said second tissue region is separate and distinct from the first tissue region;

a waveform generator coupled to the first electrode and second electrode, wherein the waveform generator is configured to generate electrical pulses to the first electrode and second electrode and wherein said electrical pulses comprise a pulse width having a range of 10 μ

sec to 500 msec;

a pulse amplitude of 1 μ

Amp to 100 mAmp; and

a pulse frequency of 1 cpm to 100 Hz; and

wherein said pulse width, pulse amplitude, pulse frequency and duty cycle for the electrical pulses transmitted to the first electrode and second electrode are defined such that, after an application of said electrical pulses, a urine volume, as measured by a weight change in an absorbent pad, decreases by at least five percent as compared to a urine volume absent said application of said electrical pulses.

14. The device of claim 13 wherein the first tissue region comprises at least one of a longitudinal muscle of a rectum, a circular muscle of the rectum, a muscularis mucosa of the rectum, a submucosa of the rectum, a pudendal nerve or a branch of the pudendal nerve, a conjoined longitudinal muscle, a superficial or deep parts of an external anal sphincter, an internal anal sphincter, a muscularis mucosa of an anal canal, a subserosal plexus, a longitudinal intramuscular plexus, a circular intramuscular plexus, a periglandular plexus, a myenteric (Auerbach'"'"'s) plexus, a submucosal (Meissner'"'"'s) plexus of an anorectum, vaginal tissue, and perineal tissue.

15. The device of claim 14 wherein the second tissue region comprises at least one of a longitudinal muscle of a rectum, a circular muscle of the rectum, a muscularis mucosa of the rectum, a submucosa of the rectum, a pudendal nerve or a branch of the pudendal nerve, a conjoined longitudinal muscle, a superficial or deep parts of an external anal sphincter, an internal anal sphincter, a muscularis mucosa of an anal canal, a subserosal plexus, a longitudinal intramuscular plexus, a circular intramuscular plexus, a periglandular plexus, a myenteric (Auerbach'"'"'s) plexus, a submucosal (Meissner'"'"'s) plexus of an anorectum, vaginal tissue, and perineal tissue.

16. The device of claim 13, wherein the electrical pulses transmitted to the first electrode have a different pulse width, pulse amplitude, or pulse frequency than the electrical pulses transmitted to the second electrode.

17. The device of claim 13, wherein the electrical pulses transmitted to the first electrode have a pulse width, a pulse amplitude, and a pulse frequency that is equal to a pulse width, a pulse amplitude, and a pulse frequency of the electrical pulses transmitted to the second electrode.

18. The device of claim 13 further comprising at least one sensor configured to obtain data, wherein said waveform generator is configured to use said data to modify at least one of the electrical pulses transmitted to the first electrode and the electrical pulses transmitted to the second electrode.

19. The device of claim 18, wherein said at least one sensor comprises a pressure sensor, an electrical activity sensor, an impedance sensor, an accelerometer, or an inclinometer.

20. A device for improving a urinary sphincter function of a patient, comprising:

a first electrode configured to contact a first tissue region, wherein said first tissue region is not in physical contact with the internal urinary sphincter;

a second electrode configured to contact a second tissue region, wherein said second tissue region is not in physical contact with the internal urinary sphincter, wherein said second tissue region is separate and distinct from the first tissue region;

a waveform generator coupled to the first electrode and second electrode, wherein the waveform generator is configured to generate electrical pulses to the first electrode and second electrode and wherein said electrical pulses comprise a pulse width having a range of 10 μ

sec to 500 msec;

a pulse amplitude of 1 μ

Amp to 100 mAmp; and

a pulse frequency of 1 cpm to 100 Hz; and

wherein said pulse width, pulse amplitude, pulse frequency and duty cycle for the electrical pulses transmitted to the first electrode and second electrode are defined such that a number of incontinent episodes or a mean incontinence volume per episode decreases by at least five percent.

21. A device for improving a urinary sphincter function of a patient, comprising:

a first electrode configured to contact a first tissue region, wherein said first tissue region is not in physical contact with an internal urinary sphincter of the patient;

a second electrode configured to contact a second tissue region, wherein said second tissue region not in physical contact with said internal urinary sphincter of the patient, wherein at least one of the first electrode and second electrode is at least 1 cm away from the internal urinary sphincter of the patient;

a waveform generator coupled to the first electrode and second electrode, wherein the waveform generator is configured to generate electrical pulses to the first electrode and second electrode and wherein said electrical pulses comprise a pulse width having a range of 10 μ

sec to 500 msec;

a pulse amplitude of 1 μ

Amp to 100 mAmp; and

a pulse frequency of 1 cpm to 100 Hz;

wherein said pulse width, pulse amplitude, pulse frequency and duty cycle for the electrical pulses transmitted to the first electrode and second electrode are defined such that, after an application of said electrical pulses, an abdominal leak pressure increases by at least five percent relative to an abdominal leak pressure prior to said application of said electrical pulses or such that, after an application of said electrical pulses, an abdominal leak volume increases by at least five percent relative to an abdominal leak volume prior to said application of said electrical pulses.

22. The device of claim 21 wherein the first tissue region comprises at least one of a longitudinal muscle of a rectum, a circular muscle of the rectum, a muscularis mucosa of the rectum, a submucosa of the rectum, a pudendal nerve or a branch of the pudendal nerve, a conjoined longitudinal muscle, a superficial or deep parts of an external anal sphincter, an internal anal sphincter, a muscularis mucosa of an anal canal, a subserosal plexus, a longitudinal intramuscular plexus, a circular intramuscular plexus, a periglandular plexus, a myenteric (Auerbach'"'"'s) plexus, a submucosal (Meissner'"'"'s) plexus of an anorectum, vaginal tissue, and perineal tissue.

23. The device of claim 22 wherein the second tissue region comprises at least one of a longitudinal muscle of a rectum, a circular muscle of the rectum, a muscularis mucosa of the rectum, a submucosa of the rectum, a pudendal nerve or a branch of the pudendal nerve, a conjoined longitudinal muscle, a superficial or deep parts of an external anal sphincter, an internal anal sphincter, a muscularis mucosa of an anal canal, a subserosal plexus, a longitudinal intramuscular plexus, a circular intramuscular plexus, a periglandular plexus, a myenteric (Auerbach'"'"'s) plexus, a submucosal (Meissner'"'"'s) plexus of an anorectum, vaginal tissue, and perineal tissue.

24. The device of claim 21, wherein said second tissue region is separate and distinct from the first tissue region.

25. The device of claim 21, wherein the electrical pulses transmitted to the first electrode have a different pulse width, pulse amplitude, or pulse frequency than the electrical pulses transmitted to the second electrode.

26. The device of claim 21, wherein the electrical pulses transmitted to the first electrode have a pulse width, a pulse amplitude, and a pulse frequency that is equal to a pulse width, a pulse amplitude, and a pulse frequency of the electrical pulses transmitted to the second electrode.

27. The device of claim 21 further comprising at least one sensor configured to obtain data, wherein said waveform generator is configured to use said data to modify at least one of the electrical pulses transmitted to the first electrode and the electrical pulses transmitted to the second electrode.

28. The device of claim 27, wherein said at least one sensor comprises a pressure sensor, an electrical activity sensor, an impedance sensor, an accelerometer, or an inclinometer.

29. The device of claim 21 further comprising a controller adapted to modify at least one of the electrical pulses transmitted to the first electrode and the electrical pulses transmitted to the second electrode based upon an input from said patient.

30. The device of claim 21 further comprising a transceiver for receiving and transmitting data and/or power from outside the patient'"'"'s body through inductive, radiofrequency (RF), electrical, magnetic, optical or other electromagnetic coupling.

31. The device of claim 21 further comprising an integrated circuit (IC) chip for decoding and storing a plurality of stimulation parameters and generating said electrical pulses and a programmable memory for storing data and stimulation parameters.