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

• US 9,950,160 B2
• Filed: 03/07/2014
• Issued: 04/24/2018
• 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): MAHMOOD, NADIA AHMAD
• Application Number:
  US14/201,659
• Publication Number:
  US 20140309708A1
• Time in Patent Office: 1,509 Days
• Field of Search: 607 39- 41
• CPC Class Codes: A61N 1/0512 Anal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• 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 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A system and method for treating anorectal dysfunction includes implanting, in a minimally invasive manner, an electro-medical device for stimulation of two or more separate and distinct anatomical or histological structures of the anorectal 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. Smooth muscle, such as the internal anal sphincter, is provided with a continuous stimulation algorithm, while skeletal muscle, such as the external anal sphincter, is provided with an on demand stimulation algorithm. Varying stimulation algorithms applied to multiple structures results in improved anorectal function without developing muscle fatigue and tolerance.

Claims

1. A system for improving a patient'"'"'s anorectal function, comprising:

at least one electrode configured to contact a region comprising an internal anal sphincter of the patient;

a microcontroller comprising a non-transitory programmable memory for storing stimulation parameters; and

a waveform generator coupled to the electrodes, wherein the waveform generator is configured to be directed by the microcontroller to generate electrical pulses and wherein said electrical pulses are defined by said stimulation parameters, including a pulse width, a pulse amplitude, a pulse frequency, and a duty cycle, wherein said pulse width, pulse amplitude, pulse frequency and duty cycle, as stored in the programmable memory, are defined such that the pulse width is in a range of 10 μ

sec to 500 msec, the pulse amplitude is in a range of 1 μ

Amp to 100 mAmp, the pulse frequency is in a range of 0.02 Hz to 100 Hz, and the duty cycle is in a range of 1 to 100% and a stimulation defined by said pulse width, pulse amplitude, pulse frequency, and duty cycle does not inhibit voluntary defecation by the patient when said stimulation is occurring, and wherein the electrical pulses are applied to the internal anal sphincter without sensing for defecation.

2. The system of claim 1 further comprising a second electrode configured to contact a region comprising an external anal sphincter.

3. The system of claim 2 wherein the waveform generator is coupled to the second electrode and is configured to generate electrical pulses to the external anal sphincter.

4. The system of claim 3 wherein the electrical pulses to the external anal sphincter have a different duration than the electrical pulses to the internal anal sphincter.

5. The system of claim 3 wherein the electrical pulses to the external anal sphincter have a different frequency than the electrical pulses to the internal anal sphincter.

6. The system of claim 3 wherein the electrical pulses to the external anal sphincter have a different duration and a different frequency than the electrical pulses to the internal anal sphincter.

7. The system of claim 3 wherein the electrical pulses to the external anal sphincter and the electrical pulses to the internal anal sphincter, in combination, modulate a composite anal sphincter pressure.

8. A system for improving a patient'"'"'s anorectal function, comprising:

electrodes configured to contact a region comprising an internal anal sphincter of the patient and a region comprising an external anal sphincter of the patient;

a microcontroller comprising a non-transitory programmable memory configured to store stimulation parameters; and

a waveform generator coupled to the electrodes, wherein the waveform generator is configured to be directed by the microcontroller to generate a first set of electrical pulses to the internal anal sphincter and a second set of electrical pulses to the external anal sphincter, wherein said first set of electrical pulses are defined by said stimulation parameters including a pulse width, a pulse amplitude, and a pulse frequency, wherein said pulse width, pulse amplitude, and pulse frequency, as stored in the programmable memory, are defined such that the pulse width is in a range of 10 μ

sec to 500 msec, the pulse amplitude is in a range of 1 μ

Amp to 100 mAmp, the pulse frequency is in a range of 0.02 Hz to 100 Hz, and the first set of electrical pulses, as defined by said pulse width, pulse amplitude, and pulse frequency, does not inhibit voluntary defecation by the patient when the first set of electrical pulses is occurring, wherein the second set of electrical pulses have at least one of a longer duration and/or a lower frequency than the first set of electrical pulses, and wherein the first set of electrical pulses are applied to the internal anal sphincter without sensing for defecation or the second set of electrical pulses are applied to the external anal sphincter without sensing for defecation.

9. The system of claim 8 wherein said pulse width, pulse amplitude, and pulse frequency of the first set of electrical pulses are defined such that the patient'"'"'s anal sphincter muscle tone is raised.

10. The system of claim 9 wherein said pulse width, pulse amplitude, and pulse frequency of the second set of electrical pulses are defined such that the patient'"'"'s urge to defecate is modulated.

11. The system of claim 10 wherein the electrical pulses to the external anal sphincter and the electrical pulses to the internal anal sphincter, in combination, modulate a composite anal sphincter pressure.

12. The system of claim 8 wherein said pulse width, pulse amplitude, and pulse frequency of the second set of electrical pulses are defined such that the patient'"'"'s urge to defecate is modulated.

13. The system of claim 8 wherein the electrical pulses to the external anal sphincter and the electrical pulses to the internal anal sphincter, in combination, modulate a composite anal sphincter pressure.

14. The system of claim 8, wherein the electrodes are at least one of a depolarizing electrode and/or a hyperpolarizing electrode.

15. The system of claim 8 further comprising a memory configured to store at least one of the patient'"'"'s clinical symptoms and/or rectal manometry data.