EP4688122A1 - Electrical stimulation to improve bowel control - Google Patents

Abstract

Systems and methods for improving fecal continence of a patient are disclosed. The method 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.

Description

ELECTRICAL STIMULATION TO IMPROVE BOWEL CONTROL

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to and the benefit of the filing date of U.S. Provisional Application No. 63/494,397, filed April 5, 2024, the entirety of which is hereby incorporated by reference herein.

FIELD

[0002] This disclosure relates to systems and methods for providing electrical stimulation (e.g., genital nerve stimulation) to improve bowel control.

BACKGROUND

[0003] Individuals can struggle with bowel dysfunction and fecal incontinence from idiopathic or neurogenic etiology. Those individuals have few options for managing their bowel. Women and men with bowel dysfunction live with the constant worry that they could have a bowel accident and will plan their out-of-house time accordingly. This worry can significantly, adversely affect their well-being, and their participation in work and social activities.

[0004] Current standard of care relies on exercise and diet with an appropriate amount of fiber. Accordingly, a system for improving bowel control for such individuals is desirable.

SUMMARY

[0005] A method for improving fecal continence of a patient is disclosed. The method comprises applying a stimulation routine to genitals of the patient. The stimulation can be provided noninvasively.

[0006] In some aspects, 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. [0007] In one aspect, 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.

[0008] Additional advantages of the invention will be set forth in part in the description that follows, and in part will be obvious from the description, or may be learned by practice of the invention. The advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.

DESCRIPTION OF THE DRAWINGS

[0009] These and other features of the preferred embodiments of the invention will become more apparent in the detailed description in which reference is made to the appended drawings wherein:

[0010] 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.

[0011] 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.

[0012] FIG. 3 shows an exemplary stimulator as disclosed herein.

[0013] FIG. 4 shows exemplary positions for positioning electrodes on a female patient for stimulation as disclosed herein.

[0014] FIG. 5 shows exemplary positions for positioning electrodes on a male patient for stimulation as disclosed herein.

DETAILED DESCRIPTION

[0015] The present invention now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. Indeed, this invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout. It is to be understood that this invention is not limited to the particular methodology and protocols described, as such may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention.

[0016] Many modifications and other embodiments of the invention set forth herein will come to mind to one skilled in the art to which the invention pertains having the benefit of the teachings presented in the foregoing description and the associated drawings. Therefore, it is to be understood that the invention is not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

[0017] As used herein the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. For example, unless the context dictates otherwise, use of the term “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.

[0018] All technical and scientific terns used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this invention belongs unless clearly indicated otherwise.

[0019] As used herein, the terms “optional” or “optionally” mean that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.

[0020] As used herein, 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.

[0021] 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. Optionally, in some aspects, when values are approximated by use of the antecedent “about,” it is contemplated that values within up to 15%, up to 10%, up to 5%, or up to 1% (above or below) of the particularly stated value can be included within the scope of those aspects.

[0022] It is to be understood that unless otherwise expressly stated, it is in no way intended that any method set forth herein be construed as requiring that its steps be performed in a specific order. Accordingly, where a method claim does not actually recite an order to be followed by its steps or it is not otherwise specifically stated in the claims or descriptions that the steps are to be limited to a specific order, it is in no way intended that an order be inferred, in any respect. This holds for any possible non-express basis for interpretation, including: matters of logic with respect to arrangement of steps or operational flow; plain meaning derived from grammatical organization or punctuation; and the number or type of aspects described in the specification.

[0023] The following description supplies specific details in order to provide a thorough understanding. Nevertheless, the skilled artisan would understand that the apparatus, system, and associated methods of using the apparatus can be implemented and used without employing these specific details. Indeed, the apparatus, system, and associated methods can be placed into practice by modifying the illustrated apparatus, system, and associated methods and can be used in conjunction with any other apparatus and techniques conventionally used in the industry.

[0024] Disclosed herein, with reference to FIGS. 1-5, is a method for treating fecal incontinence. 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). In some aspects, 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. For example, 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. In exemplary aspects, 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. It is further contemplated that the stimulation routine can comprise parameters (e.g., current, pulse width, or frequency) outside of the foregoing ranges. In some aspects, the stimulation routine can be constant. In other aspects, the stimulation routine can vary. Optionally, the stimulation routine can be random. For example, 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.

[0025] In some aspects, 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).

[0026] FIG. 1 illustrates GNS administration with a transcutaneous electrical nerve stimulation (TENS) system 10. Non-invasive surface stimulation can be used to reduce fecal incontinence with minimal inconvenience to the wearer. Referring to FIG. 2, in some aspects, commercially available, FDA-approved stimulation devices can be used without modification to provide the stimulation. In other aspects, the stimulation can be provided by a stimulation system 10 particularly configured for providing genital stimulation for fecal incontinence.

[0027] In some aspects, 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). For example, 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. For example, 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. It is contemplated that 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.

[0028] Referring to FIG. 4, in some aspects, for female-bodied individuals, electrodes can be applied on the labia majora to target the genital nerve. For example, the first electrode 20a can be placed on the labia majora on a first side 24a, and 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. In some aspects, the first and second electrodes can be placed so that the clitoris is between the first and second electrodes along the frontal axis 2.

[0029] Referring to FIG. 5, in some aspects, for male-bodied individuals, one or more electrodes can be placed on or near the penis. For example, in some aspects, a first electrode 20a can be placed in a first location 22a along a longitudinal dimension of the penis, and a second electrode 20b can be placed in a second location 22b along the longitudinal dimension of the penis. Optionally, the one or more electrodes 20 can be placed on the dorsal surface of the penis. In further aspects, the electrodes can be placed in different circumferential positions about the penis. For example, one or both of the first and second electrodes 20a, b can be positioned on the ventral side of the penis. In still further aspects, 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. In additional aspects, the first and second electrodes 20a, b can be positioned on opposite sides of the penis along the frontal axis. In some aspects, one, at least two, or all of the electrodes 20 can be placed on the shaft of the penis. For example, as shown in FIG. 5, two electrodes can be positioned on the shaft of the penis. In other aspects, 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.

[0030] Referring to FIGS. 1-2B, the system 10 can be worn by the patient. For example, 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. Optionally, the strap can comprise a receptacle for receiving the signal generator. In some aspects, the strap 30 can be configured to be worn around the waist of the patient. In other aspects, the at least one strap 30 can extend over one or both shoulders of the patient. Thus, it is contemplated that the signal generator 12 can be worn externally by the patient during use and selectively removed from the patient. [0031] In some aspects, the system 10 can comprise an input device 14 for receiving an input or instruction to control the signal generator 12. For example, 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. In this way, when the patient desires to evacuate his/her bowels (FIG. 2B), the stimulation routine can be halted. When the patient desires to inhibit bowel evacuation (FIG. 2A), the stimulation routine can be started. In further aspects, 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). In these aspects, it is contemplated that 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. Optionally, 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. In some aspects, the input device 14 can be in communication through the signal generator through an electrical cable. In other aspects, as shown in FIG. 3, the input device 14 can be integrated into the structure of the signal generator 12. In exemplary aspects, when a strap 30 is provided, it is contemplated that 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).

[0032] 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.

[0033] In some aspects, the stimulation can be provided by an INTERSTEM stimulating system (MEDTRONIC, Minneapolis MN). However, 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. In various aspects, the stimulation system of the disclosed systems and methods can be non-invasive.

EXEMPLARY ASPECTS

[0034] In view of the described products, systems, and methods and variations thereof, herein below are described certain more particularly described aspects of the invention. These particularly recited aspects should not however be interpreted to have any limiting effect on any different claims containing different or more general teachings described herein, or that the “particular” aspects are somehow limited in some way other than the inherent meanings of the language literally used therein.

[0035] 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.

[0036] Aspect 2: The method of aspect 1, wherein the stimulation is provided non-invasively.

[0037] Aspect 3: The method of aspect 1, wherein the stimulation is provided by one or more electrodes positioned on skin of the patient.

[0038] Aspect 4: The method of aspect 3, wherein the one or more electrodes are positioned on labia majora of the patient.

[0039] 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.

[0040] 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.

[0041] Aspect 7: The method of aspect 6, wherein the genital nerve branch comprises a dorsal penile nerve.

[0042] Aspect 8: The method of aspect 6, wherein the genital nerve branch comprises a clitoral nerve.

[0043] 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.

[0044] Aspect 10: The method of any one of the preceding aspects, wherein the stimulation routine has a frequency from 5 Hz to 100 Hz. [0045] Aspect 11 : The method of any one of the preceding aspects, wherein the stimulation routine has a frequency of about 20 Hz.

[0046] 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.

[0047] Aspect 13 : The method of any one of the preceding aspects, wherein the stimulation routine has a pulse width of about 0.2 ms.

[0048] Aspect 14: The method of any one of the preceding aspects, wherein the stimulation routine has a current from 0-200 mA.

[0049] Aspect 15 : The method of any one of the preceding aspects, wherein the stimulation routine has a current from 0-60 mA.

[0050] Aspect 16: The method of any one of the preceding aspects, wherein the patient has been diagnosed with fecal incontinence.

[0051] Aspect 17: The method of any one of the preceding aspects, wherein the patient has experienced fecal incontinence within a week.

[0052] Aspect 18: The method of any one of the preceding aspects, wherein the patient has experienced fecal incontinence within a day.

[0053] Aspect 19: 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.

[0054] Aspect 20: The system of aspect 19, wherein the plurality of electrodes are surface electrodes. [0055] 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.

[0056] Aspect 22: The system of aspect 21, further comprising a strap coupled to the signal generator.

[0057] 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.

[0058] 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.

[0059] Aspect 25 : The system of aspect 24, wherein the input device comprises a button, switch, or touchscreen.

[0060] 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.

[0061] 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.

[0062] Aspect 28: The system of aspect 27, wherein the one or more parameters comprise amplitude, frequency, or pulse width.

[0063] 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.

[0064] 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.

[0065] Aspect 31 : The system of any one of aspects 24-40, wherein the input device is integrated into the structure of the signal generator. [0066] Aspect 32: The system of any one of aspects 19-31, wherein the stimulation routine has a frequency from 5 Hz to 100 Hz.

[0067] Aspect 33: The system of any one of aspects 19-32, wherein the stimulation routine has a frequency of about 20 Hz.

[0068] 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.

[0069] Aspect 35: The system of any one of aspects 19-34, wherein the stimulation routine has a pulse width of about 0.2 ms.

[0070] Aspect 36: The system of any one of aspects 19-35, wherein the stimulation routine has a current from 0 mA to 200 mA.

[0071] Aspect 37: The system of any one of aspects 19-36, wherein the stimulation routine has a current from 0 mA to 60 mA.

[0072] Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, certain changes and modifications may be practiced within the scope of the appended claims.

Claims

CLAIMS What is claimed is:

1. 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.

2. The system of claim 1, wherein the plurality of electrodes are surface electrodes.

3. The system of claim 2, 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 the genitals of the patient.

4. The system of claim 3, further comprising a strap coupled to the signal generator.

5. The system of claim 3, wherein the plurality of electrodes are configured to be positioned on skin of the patient.

6. The system of claim 5, further comprising an input device that is in communication with the signal generator and configured to receive an input to control the signal generator.

7. The system of claim 6, wherein the input device comprises a button, switch, or touchscreen.

8. The system of claim 6, wherein the input device is configured to receive inputs that selectively stop and start the stimulation routine.

9. The system of claim 8, wherein the input device is configured to receive inputs that selectively adjust one or more parameters associated with the stimulation routine.

10. The system of claim 9, wherein the one or more parameters comprise amplitude, frequency, or pulse width.

11. The system of claim 9, 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.

12. The system of claim 6, wherein the input device further comprises a display that displays an operational status or parameter settings of the signal generator.

13. The system of claim 6, wherein the input device is integrated into the structure of the signal generator.

14. The system of any one of claims 1-13, wherein the stimulation routine has a frequency from 5 Hz to 100 Hz.

15. The system of any one of claims 1-13, wherein the stimulation routine has a frequency of about 20 Hz.

16. The system of any one of claims 1-13, wherein the stimulation routine has a pulse width of from 0.05 ms to 1 ms.

17. The system of any one of claims 1-13, wherein the stimulation routine has a pulse width of about 0.2 ms.

18. The system of any one of claims 1-13, wherein the stimulation routine has a current from 0 mA to 200 mA.

19. The system of any one of claims 1-13, wherein the stimulation routine has a current from 0 mA to 60 mA.