EP4688122A1 - Stimulation électrique pour améliorer le contrôle des intestins - Google Patents

Stimulation électrique pour améliorer le contrôle des intestins

Info

Publication number
EP4688122A1
EP4688122A1 EP24785845.9A EP24785845A EP4688122A1 EP 4688122 A1 EP4688122 A1 EP 4688122A1 EP 24785845 A EP24785845 A EP 24785845A EP 4688122 A1 EP4688122 A1 EP 4688122A1
Authority
EP
European Patent Office
Prior art keywords
stimulation
electrodes
patient
aspects
signal generator
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP24785845.9A
Other languages
German (de)
English (en)
Inventor
Dennis BOURBEAU
Kimberly Anderson
James Wilson
Robert HOEY
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Case Western Reserve University
MetroHealth System
US Department of Veterans Affairs
Original Assignee
Case Western Reserve University
MetroHealth System
US Department of Veterans Affairs
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Case Western Reserve University, MetroHealth System, US Department of Veterans Affairs filed Critical Case Western Reserve University
Publication of EP4688122A1 publication Critical patent/EP4688122A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36034—Control systems specified by the stimulation parameters

Definitions

  • This disclosure relates to systems and methods for providing electrical stimulation (e.g., genital nerve stimulation) to improve bowel control.
  • electrical stimulation e.g., genital nerve stimulation
  • a method for improving fecal continence of a patient comprises applying a stimulation routine to genitals of the patient.
  • the stimulation can be provided noninvasively.
  • the stimulation is provided by one or more electrodes positioned on skin of the patient, such as the labia majora or the dorsal surface of the penis.
  • the stimulation routine can stimulate a genital nerve branch of pudendal nerves of the patient.
  • a system can include a plurality of electrodes and a signal generator that is configured to generate a stimulation routine between at least two electrodes of the plurality of electrodes.
  • the stimulation routine can be configured for improving fecal incontinence.
  • FIG. 1 is a schematic diagram showing use of the systems and methods for providing electrical stimulation (e.g., genital nerve stimulation) to improve bowel control, as disclosed herein.
  • electrical stimulation e.g., genital nerve stimulation
  • FIG. 2A shows use of the systems and methods for providing electrical stimulation to improve bowel control when not evacuating the bowels of a subject
  • FIG. 2B shows use of the systems and methods for providing electrical stimulation to improve bowel control when evacuating the bowels of the subject.
  • FIG. 3 shows an exemplary stimulator as disclosed herein.
  • FIG. 4 shows exemplary positions for positioning electrodes on a female patient for stimulation as disclosed herein.
  • FIG. 5 shows exemplary positions for positioning electrodes on a male patient for stimulation as disclosed herein.
  • an electrode constitutes disclosure of embodiments in which only one electrode is provided, and also constitutes disclosure of embodiments in which two or more of such electrodes are provided, and so forth.
  • the term “at least one of’ is intended to be synonymous with “one or more of.” For example, “at least one of A, B and C” explicitly includes only A, only B, only C, and combinations of each.
  • Ranges can be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.
  • the method can comprise applying an electrical stimulation routine to a neural target.
  • the method can comprise non-invasive stimulation of the genital nerves (GNS).
  • the method can be performed on individuals with spinal cord injury (SCI) with anorectal reflex activity.
  • GNS can be applied using a surface stimulation device and surface electrodes.
  • the neural target can be the genital nerve branch of the pudendal nerves.
  • the neural target can be the dorsal penile nerve for men or the clitoral nerve in women. Both of these neural targets can be activated non-invasively using surface electrodes.
  • the stimulation routine can have a frequency from about 5 Hz to about 100 Hz or from about 10 Hz to about 50 Hz (optionally, about 20 Hz). In exemplary aspects, the stimulation routine can have a pulse width from 0.05 ms to 1 ms or from 0.1 ms to 0.5 ms (optionally, about 0.2 ms). In exemplary aspects, the stimulation routine can have a current from about 0 mA to about 200 mA or from 0 mA to about 100 mA (optionally, about 0 mA to about 60 mA) as applied via surface electrodes on the skin.
  • the stimulation routine can comprise parameters (e.g., current, pulse width, or frequency) outside of the foregoing ranges.
  • the stimulation routine can be constant.
  • the stimulation routine can vary.
  • the stimulation routine can be random.
  • one or more of the parameters (current, pulse width, and/or frequency) can be randomly generated. It is contemplated that changing the stimulation routine can inhibit reduced efficacy from the patient adapting to the stimulation routine.
  • the patient has been diagnosed with fecal incontinence. In some aspects, the patient has experienced fecal incontinence within a week. In further aspects, the patient has experienced fecal incontinence within a day (e.g., within a 24 hour period of stimulation).
  • FIG. 1 illustrates GNS administration with a transcutaneous electrical nerve stimulation (TENS) system 10.
  • TENS transcutaneous electrical nerve stimulation
  • Non-invasive surface stimulation can be used to reduce fecal incontinence with minimal inconvenience to the wearer.
  • commercially available, FDA-approved stimulation devices can be used without modification to provide the stimulation.
  • the stimulation can be provided by a stimulation system 10 particularly configured for providing genital stimulation for fecal incontinence.
  • the stimulation system 10 can comprise a signal generator 12.
  • the stimulation system 10 can further comprise at least one electrode (optionally, a plurality of electrodes).
  • the stimulation system 10 can comprise a first electrode 20a and a second electrode 20b.
  • the electrodes can be surface electrodes as are known in the art.
  • the electrodes can be bar electrodes, disc electrodes, ground electrodes, ring electrodes, or combinations thereof, and it is contemplated that the electrodes can be either disposable (for single-patient use) or re-usable.
  • the electrodes can comprise adhesive material (optionally, a hydrogel layer) that contacts the skin of the patient to securely position the electrodes on the body of the patient as further disclosed herein.
  • the signal generator 12 can be configured to generate a stimulation routine between at least two electrodes of the plurality of electrodes 20.
  • electrodes can be applied on the labia majora to target the genital nerve.
  • the first electrode 20a can be placed on the labia majora on a first side 24a
  • the second electrode 20b can be placed on the labia majora on an opposite, second side 24b along a frontal axis 2 of the patient.
  • the first and second electrodes can be placed so that the clitoris is between the first and second electrodes along the frontal axis 2.
  • one or more electrodes can be placed on or near the penis.
  • a first electrode 20a can be placed in a first location 22a along a longitudinal dimension of the penis
  • a second electrode 20b can be placed in a second location 22b along the longitudinal dimension of the penis.
  • the one or more electrodes 20 can be placed on the dorsal surface of the penis.
  • the electrodes can be placed in different circumferential positions about the penis.
  • one or both of the first and second electrodes 20a, b can be positioned on the ventral side of the penis.
  • the first electrode 20a can be positioned on the dorsal surface of the penis and the second electrode 20b can be positioned on the ventral surface of the penis.
  • the first and second electrodes 20a, b can be positioned on opposite sides of the penis along the frontal axis.
  • one, at least two, or all of the electrodes 20 can be placed on the shaft of the penis.
  • two electrodes can be positioned on the shaft of the penis.
  • the first electrode 20a can be positioned on the shaft of the penis, and a second electrode 20b can be positioned at the base of the penis.
  • the system 10 can be worn by the patient.
  • the system 10 can comprise at least one strap 30 that is coupled to the signal generator 12 and that secures the signal generator to the patient.
  • the strap can comprise a receptacle for receiving the signal generator.
  • the strap 30 can be configured to be worn around the waist of the patient.
  • the at least one strap 30 can extend over one or both shoulders of the patient.
  • the signal generator 12 can be worn externally by the patient during use and selectively removed from the patient.
  • the system 10 can comprise an input device 14 for receiving an input or instruction to control the signal generator 12.
  • the input device 14 can comprise a button, switch, touchscreen, or the like for receiving an input from a user to start or stop the stimulation routine.
  • the stimulation routine can be halted.
  • the input device 14 can permit modification of the stimulating routine (e.g., adjustment of one or more parameters, such as amplitude, frequency, or pulse width).
  • the input device 14 can further comprise one or more buttons, knobs, switches, and/or touchscreen areas that are configured to allow for adjustment of one or more stimulation parameters.
  • the input device 14 can comprise a display or other indicator that provides a visual indication of the operational status and/or parameter settings of the signal generator 12.
  • the input device 14 can be in communication through the signal generator through an electrical cable.
  • the input device 14 can be integrated into the structure of the signal generator 12.
  • the input device 14 can be coupled to the strap (optionally, by positioning the input device (and signal generator) in a receptacle that is coupled to the strap).
  • Fecal continence can be improved in some able-bodied individuals using electrical stimulation of sacral mixed nerves.
  • the method can activate sensory nerves and modulate spinal reflex pathways to inhibit unwanted hyperreflexic bowel function. Sacral neuromodulation has been evaluated in individuals with multiple sclerosis, but little research has been done in individuals with SCI.
  • the stimulation can be provided by an INTERSTEM stimulating system (MEDTRONIC, Minneapolis MN).
  • MEDTRONIC INTERSTEM stimulating system
  • the INTERSTEM stimulating system requires a temporary lead implant to assess eligibility over a 1 -month period, followed by permanent implantation of a pulse generator.
  • the stimulation system of the disclosed systems and methods can be non-invasive.
  • Aspect 1 A method for improving fecal continence of a patient who has experienced fecal incontinence, the method comprising: applying a stimulation routine to genitals of the patient.
  • Aspect 2 The method of aspect 1, wherein the stimulation is provided non-invasively.
  • Aspect 3 The method of aspect 1, wherein the stimulation is provided by one or more electrodes positioned on skin of the patient.
  • Aspect 4 The method of aspect 3, wherein the one or more electrodes are positioned on labia majora of the patient.
  • Aspect 5 The method of aspect 3, wherein the one or more electrodes are positioned on a dorsal surface of a penis of the patient.
  • Aspect 6 The method of aspect 1, wherein applying the stimulation routine to the genitals of the patient comprises stimulating a genital nerve branch of pudendal nerves of the patient.
  • Aspect 7 The method of aspect 6, wherein the genital nerve branch comprises a dorsal penile nerve.
  • Aspect 8 The method of aspect 6, wherein the genital nerve branch comprises a clitoral nerve.
  • Aspect 9 The method of aspect 1, further comprising placing one or more electrodes positioned on skin of the patient, wherein applying the stimulation routine to the genitals of the patient comprises applying the stimulation routine to the genitals of the patient using the one or more electrodes.
  • Aspect 10 The method of any one of the preceding aspects, wherein the stimulation routine has a frequency from 5 Hz to 100 Hz.
  • Aspect 11 The method of any one of the preceding aspects, wherein the stimulation routine has a frequency of about 20 Hz.
  • Aspect 12 The method of any one of the preceding aspects, wherein the stimulation routine has a pulse width of from 0.05 ms to 1 ms.
  • Aspect 13 The method of any one of the preceding aspects, wherein the stimulation routine has a pulse width of about 0.2 ms.
  • Aspect 14 The method of any one of the preceding aspects, wherein the stimulation routine has a current from 0-200 mA.
  • Aspect 15 The method of any one of the preceding aspects, wherein the stimulation routine has a current from 0-60 mA.
  • Aspect 16 The method of any one of the preceding aspects, wherein the patient has been diagnosed with fecal incontinence.
  • Aspect 17 The method of any one of the preceding aspects, wherein the patient has experienced fecal incontinence within a week.
  • Aspect 18 The method of any one of the preceding aspects, wherein the patient has experienced fecal incontinence within a day.
  • a system comprising: a plurality of electrodes configured to be positioned on genitals of a patient; and a signal generator configured to generate a stimulation routine between at least two electrodes of the plurality of electrodes, wherein the stimulation routine is configured to improve fecal incontinence of the patient.
  • Aspect 20 The system of aspect 19, wherein the plurality of electrodes are surface electrodes.
  • Aspect 21 The system of aspect 19 or aspect 20, wherein the signal generator is configured to be worn externally by a patient, and wherein the plurality of electrodes are configured to be non-invasively positioned on genitals of the patient.
  • Aspect 22 The system of aspect 21, further comprising a strap coupled to the signal generator.
  • Aspect 23 The system of any one of aspects 19-22, wherein the plurality of electrodes are configured to be positioned on skin of the patient.
  • Aspect 24 The system of any one of aspects 19-23, further comprising an input device that is in communication with the signal generator and configured to receive an input to control the signal generator.
  • Aspect 25 The system of aspect 24, wherein the input device comprises a button, switch, or touchscreen.
  • Aspect 26 The system of aspect 24 or aspect 25, wherein the input device is configured to receive inputs that selectively stop and start the stimulation routine.
  • Aspect 27 The system of aspect 26, wherein the input device is configured to receive inputs that selectively adjust one or more parameters associated with the stimulation routine.
  • Aspect 28 The system of aspect 27, wherein the one or more parameters comprise amplitude, frequency, or pulse width.
  • Aspect 29 The system of aspect 26 or aspect 27, wherein the input device further comprises one or more buttons, knobs, switches, or touchscreen areas that are configured to allow for adjustment of the one or more parameters.
  • Aspect 30 The system of any one of aspects 24-29, wherein the input device further comprises a display that displays an operational status or parameter settings of the signal generator.
  • Aspect 31 The system of any one of aspects 24-40, wherein the input device is integrated into the structure of the signal generator.
  • Aspect 32 The system of any one of aspects 19-31, wherein the stimulation routine has a frequency from 5 Hz to 100 Hz.
  • Aspect 33 The system of any one of aspects 19-32, wherein the stimulation routine has a frequency of about 20 Hz.
  • Aspect 34 The system of any one of aspects 19-33, wherein the stimulation routine has a pulse width of from 0.05 ms to 1 ms.
  • Aspect 35 The system of any one of aspects 19-34, wherein the stimulation routine has a pulse width of about 0.2 ms.
  • Aspect 36 The system of any one of aspects 19-35, wherein the stimulation routine has a current from 0 mA to 200 mA.
  • Aspect 37 The system of any one of aspects 19-36, wherein the stimulation routine has a current from 0 mA to 60 mA.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne des systèmes et des procédés pour améliorer la continence fécale d'un patient. Le procédé comprend l'application d'une routine de stimulation à des organes génitaux du patient. La stimulation peut être fournie de manière non invasive. La stimulation est fournie par une ou plusieurs électrodes positionnées sur la peau du patient, telles que les grandes lèvres ou la surface dorsale du pénis. La routine de stimulation peut stimuler une branche nerveuse génitale de nerfs pudendal du patient.
EP24785845.9A 2023-04-05 2024-04-05 Stimulation électrique pour améliorer le contrôle des intestins Pending EP4688122A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363494397P 2023-04-05 2023-04-05
PCT/US2024/023305 WO2024211734A1 (fr) 2023-04-05 2024-04-05 Stimulation électrique pour améliorer le contrôle des intestins

Publications (1)

Publication Number Publication Date
EP4688122A1 true EP4688122A1 (fr) 2026-02-11

Family

ID=92972904

Family Applications (1)

Application Number Title Priority Date Filing Date
EP24785845.9A Pending EP4688122A1 (fr) 2023-04-05 2024-04-05 Stimulation électrique pour améliorer le contrôle des intestins

Country Status (2)

Country Link
EP (1) EP4688122A1 (fr)
WO (1) WO2024211734A1 (fr)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2749828C (fr) * 2009-01-26 2016-02-23 University College Dublin, National University Of Ireland, Dublin Procede et appareil de stimulation des muscles du plancher pelvien
BR112013022151A2 (pt) * 2011-03-02 2020-10-20 Murdoch Childrens Reserch Institute processo e sistema de estimulação transcutânea
US10035016B2 (en) * 2014-04-14 2018-07-31 Elidah, Inc. Electrical stimulation device
US10322282B2 (en) * 2014-06-06 2019-06-18 Medtronic, Inc. External stimulation therapy for dorsal genital nerve stimulation
EP4326391A4 (fr) * 2021-04-24 2024-09-04 Indian Institute of Science Procédé, système et unité vestimentaire électronique pour commander une stimulation électrique sur la région pelvienne d'un sujet

Also Published As

Publication number Publication date
WO2024211734A1 (fr) 2024-10-10

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