Device for treatment of fecal incontinence, and method thereof

Abstract

The present disclosure is a multi-functional device and method for treating fecal incontinence and related pelvic floor disorders. The device provides mechanical closure with or without neuromuscular stimulation and / or neuromodulation for individuals suffering from incontinence. The device enhances the functionality of the perianal tissue or the tissue surrounding the anal cavity, aiding in voluntary and involuntary control over continence. It comprises a flexible, multi-layer substrate with a fecal blocking element and a buttocks support portion, which incorporates adhesive layers and a rigid or semi-rigid support structure to ensure secure placement during use. The multi-layer substrate may be with or without a perineum absorbent patch or pad. The device may also integrate electrodes for transcutaneous electrical stimulation, capable of targeting the anal sphincters or surrounding perianal tissue (including skin, fat, and muscle) or S2-S3 dermatomes, thereby raising the pressure in the anal canal, contracting the external anal sphincter, and triggering reflex contractions. A control module may be used to activate electrical stimulation in response to user-identified urges, reinforcing voluntary sphincter contractions. This disclosure provides a comprehensive, non-invasive solution for managing fecal incontinence and related pelvic floor disorders through a combination of mechanical, electrical, drug delivery, and irrigation therapies, offering both immediate and long- term therapeutic benefits.

Description

[0001] DEVICE FOR TREATMENT OF FECAL INCONTINENCE, AND METHOD

[0002] THEREOF

[0003] FIELD OF THE INVENTION

[0004] The present invention generally relates to the field of medical devices used to treat fecal incontinence in individuals. In particular, the present invention is directed to a device combining mechanical aids to achieve closure or damming of the anal opening to deal with an episode of fecal incontinence.

[0005] BACKGROUND OF THE INVENTION

[0006] Continence of stool in healthy individuals requires adequate reservoir capacity, the ability to sense stool in the rectum, and a functional sphincter mechanism that maintains secure closure against continuous urges. Fecal incontinence, also known as accidental bowel leakage (ABL), is the involuntary loss of feces. This condition may result from either muscular or neurological dysfunction, or both. Muscular dysfunction often arises from anal sphincter injury due to trauma, such as obstetric injury sustained during childbirth, conditions like colitis, or the gradual weakening of the anal sphincter muscle over time due to aging or other underlying pathologies. Alternatively, neurological dysfunction can cause fecal incontinence, often due to damage to the pudendal nerve or other nerves within the sacral plexus.

[0007] Fecal incontinence is classified into four main types:

[0008] 1. Stress incontinence - Occurs during physical exertion (e.g., sporting activities, laughing, sneezing, or coughing) due to weakened storage reflexes and sphincter function;

[0009] 2. Urge incontinence - Characterized by episodic colon contractions and / or sensations of urgency due to over-activity of voiding reflexes;

[0010] 3. Passive incontinence - Happens without the individual's awareness, resulting from the inability of the body to detect rectal fullness; and

[0011] 4. Mixed incontinence - A combination of passive and urge fecal incontinence. Fecal incontinence is a widespread, debilitating condition that affects millions worldwide. Its unpredictable nature significantly impacts the quality of life for those affected. People at risk include, but are not limited to, older adults with chronic bowel disturbances (e.g., diarrhea, IBS), individuals who have undergone cholecystectomy, lower spinal or rectal surgeries, or those with neurological disorders (e.g., diabetes, multiple sclerosis, spinal or rectal injuries). Men who have received prostate treatment and women who sustained obstetric injuries, such as anal sphincter tears or perineal trauma during childbirth, are also at increased risk.

[0012] Despite its prevalence, current devices and treatment options do not provide an adequate solution for fecal incontinence sufferers. Traditional incontinence pads and anal inserts are often conspicuous and uncomfortable, and they may not effectively prevent fecal matter from exiting the cluneal cleft. Neuromuscular stimulation, using targeted, usually invasive, electrical impulses sessions, has shown potential in training pelvic floor muscles to improve fecal incontinence symptoms. However, they require a training regime for significant amount of time, making many to give up throughout the process, not seeing any improvement. Additionally, neuromodulation therapy through implantable sacral nerve stimulation has demonstrated substantial clinical benefits. However, it is invasive and expensive procedure most patients are not eligible to. Physiotherapy, which focuses on pelvic floor muscle training, can also aid in symptom management; however, the lack of effective feedback tools and the need for frequent clinic visits can limit its success and accessibility for patients.

[0013] Existing devices do not offer a non-invasive solution that combines efficient, immediate, continuous, and comfortable for fecal incontinence. This lack of a comprehensive, user- friendly solution limits the daily activities of affected individuals.

[0014] Therefore, there is a critical need for a discreet, non-invasive, and user-friendly device that addresses the unique challenges of fecal incontinence. Such a device would ideally provide immediate, on-demand relief as well as long-term therapeutic benefits, making it easier for individuals to manage their condition while maintaining an active, unrestricted lifestyle. Additionally, the device would ideally support physiotherapy and muscle training, enabling users to strengthen their pelvic floor muscles independently or with guidance, potentially using real-time feedback from integrated sensors, such as electromyography (EMG), to maximize effectiveness. This invention introduces a novel device that fulfills this need, offering mechanical closure, dual-mode neuromodulation, and support for physiotherapy as an integrated solution. This approach provides a non-invasive, therapeutic option that improves both voluntary and involuntary control of the anal sphincter while enabling at-home pelvic floor training, enhancing the quality of life for those suffering from fecal incontinence.

[0015] SUMMARY OF THE INVENTION

[0016] The present invention is directed towards a device and method providing both mechanical closure with or without neuromuscular stimulation and / or neuromodulation for individuals suffering from incontinence. The device enhances the functionality of the perianal tissue or the tissue surrounding the anal cavity, aiding in voluntary and involuntary control over continence. In certain embodiments, the device is coupled to one or more electrodes configured to deliver transcutaneous electrical acute stimulation to the anal sphincters or surrounding perianal tissue (including skin, fat, and muscle) or S2-S3 dermatomes. This stimulation specifically targets the perianal region or both the perianal region and anal sphincters, thereby raising the pressure in the anal canal, contracting the external anal sphincter, and triggering reflex contractions. This enhances the responsiveness of the sphincter to neural signals, improving voluntary and involuntary control over continence and managing detrusor instability.

[0017] In additional embodiments, the device enables continuous transcutaneous neuromodulation of the anal sphincters or surrounding perianal tissue (including skin, fat, and muscle) or S2-S3 dermatomes or the pudendal nerve or other pelvic nerves, acting as a non-invasive alternative to sacral nerve stimulation. This approach provides therapeutic neuromodulation without surgical intervention, thereby expanding treatment options for individuals seeking a non-invasive solution.

[0018] In further embodiments, the device supports physiotherapy and pelvic floor training, either as a standalone therapy or in conjunction with guided physiotherapy sessions. The device can be used independently by individuals to build pelvic floor strength and responsiveness, or under professional supervision to enhance the effectiveness of physiotherapy exercises. In certain embodiments, the device may be coupled with sensors, such as electromyography (EMG) sensors, to provide real-time feedback on muscle activation and enable personalized training protocols. This integration facilitates tailored muscle training, improving muscle control and overall continence over time.

[0019] In other embodiments, the device may support a drug slow -release system by incorporating a therapeutic coating on the anal closure element. This system can deliver bioactive compounds, such as drugs, pain relievers, antibiotics, nanoparticles, or growth factors, directly to the targeted tissue, providing localized treatment for associated conditions.

[0020] In further embodiments, the device may incorporate an irrigation platform that directs fluid injection into the lower bowel via the rectum, stimulating bowel emptying for individuals requiring assistance with lower bowel clearance.

[0021] In other embodiments, the device may assist individuals suffering from constipation by facilitating bowel movements through enhanced stimulation of the anus. These embodiments allow the buttocks to move during physical activity, such as sports, generating stimulation that promotes a bowel movement response.

[0022] This invention provides a multi-functional therapeutic platform capable of addressing various pelvic floor and continence -related conditions through mechanical support, electrical stimulation, neuromodulation, drug delivery, irrigation, and physiotherapy training solutions. This comprehensive approach offers both immediate and long-term therapeutic benefits for managing incontinence and related pelvic floor disorders.

[0023] In one aspect of the invention, a device for treatment of fecal incontinence in an individual in need thereof, characterized by a multi-layer substrate with: a. a rectal portion, comprising a fecal blocking element; interconnected with b. a buttocks support portion, comprising flexible members with rigid ribs and at least one adhesive layer on the proximal side of the substrate configured to face a buttocks skin surface of the individual.

[0024] In another aspect of the invention, the device above is provided, wherein the rigid or semi-rigid portions comprising a rigid or semi-rigid support structure with higher rigidity than the rectal portion, the flexible portions of the buttocks support portion, and the at least one adhesive layer; the support structure formed from a high shore silicone or a plastic or a metal or another general- purpose hard material in a shape comprising: a. a center portion; b. a first side portion with at least one reinforcement rib arching outward and away from the center portion on one side; and c. a second side portion with at least one reinforcement rib arching outward and away from the center portion on an opposite side.

[0025] In another aspect of the invention, the device as defined in any of above is provided, wherein the at least one reinforcement rib embedded within the flexible portions and cushioned in an adhesive foam layer.

[0026] In another aspect of the invention, the device as defined in any of above is provided, wherein buckling effect of the rigid or semi-rigid support structure is prevented by the reinforcement of the at least one adhesive layer adhering to a skin surface; unintentional peeling effect of the at least one adhesive layer is prevented by the reinforcement of the rigid or semi-rigid support structure; the at least one adhesive layer and the rigid or semi-rigid support structure synergistically operate to prevent expulsion of feces from the device.

[0027] In another aspect of the invention, the device as defined in any of above is provided, wherein the at least one reinforcement rib of the support structure comprising at least two reinforcement ribs; the at least two reinforcement ribs comprising a plurality of reinforcement ribs; the plurality of reinforcement ribs arranged in a symmetrical fan-like manner emanating from the center portion of the support structure.

[0028] In another aspect of the invention, the device as defined in any of above is provided, wherein the at least two reinforcement ribs or the plurality of reinforcement ribs embedded within the flexible portions and cushioned in an adhesive foam layer.

[0029] In another aspect of the invention, the device as defined in any of above is provided, wherein the flexible portions of the buttocks support portion comprising: a. a center portion; b. a first side portion; and c. a second side portion on an opposite side with at least one adhesive layer on the proximal side of the substrate against a skin surface of an individual; the at least one adhesive layer comprising at least two adhesive layers; the at least two adhesive layers comprising two adhesive layer types; the two adhesive layer types comprising a light skin adhesive sheet and medium or strong skin adhesive sheet. In another aspect of the invention, the device as defined in any of above is provided, wherein the at least one adhesive layer having at least one removable liner; the at least one removable liner covering the center portion, first side portion and second side portion of the flexible portions of the buttocks support portion.

[0030] In another aspect of the invention, the device as defined in any of above is provided, wherein the rigid or semi-rigid support structure having column strength enabling easy placement and application of the device by the individual by hardening the at least two adhesive layers, making each side portion a rigid body during placement.

[0031] In another aspect of the invention, the device as defined in any of above is provided, wherein the rigid or semi-rigid support structure comprising reinforcement ribs conveying axial forces to the adhesive layers to: a. prevent undesirable peeling of the adhesive layers unintentionally when applied by the feces exiting the rectum; and b. allow peeling of entire area of the adhesive layers only when intentionally applying sufficient force for detachment.

[0032] In another aspect of the invention, the device as defined in any of above is provided, wherein the rigid or semi-rigid support structure folding in the shape of an arch when applying radial force during placement and application of the device near the anal opening; the arch’s keystone achieving mechanical closure or damming of the tissue surrounding the anal cavity by applying forces comprising: a. tangential longitudinal forces towards the anal opening of the individual; and b. lateral forces between the side of the arch and tissue of the individual.

[0033] In another aspect of the invention, the device as defined in any of above is provided, wherein the rigid or semi-rigid support structure folding on itself by the individual after a fecal incontinence episode to allow discrete and hygienic disposal.

[0034] In another aspect of the invention, the device as defined in any of above is provided, wherein the multi-layer substrate has a cross-sectional shape that is substantially in the form of an "eight, " such that the multi-layer substrate includes a central portion and two interconnected, opposing first and second loops, each loop being formed to conform to the anatomical contours of the individual’s intergluteal cleft, buttocks and perineum, providing a secure fit and enhanced sealing of the device during use.

[0035] In another aspect of the invention, the device as defined in any of above is provided, wherein the first loop comprises a fecal blocking element and the second loop comprises a urinary blocking element.

[0036] In another aspect of the invention, the device as defined in any of above is provided, wherein the fecal blocking element of the rectal portion comprising a three-dimensional component formed from an elastomer or a plastic; the component may have a shape selected from the group consisting of a circular shape, an oval shape, a dome shape, a rectangular shape, a lobed shape (e.g., a butterfly shape), a cone shape, a cylindrical shape, a spiral shape, a concave shape, a convex shape, a ball-headed shape, and the like.

[0037] In another aspect of the invention, the device as defined in any of above is provided, wherein the fecal blocking element is provided with a disposable cover layer configured to receive feces exiting the rectum during a fecal incontinence episode, after which the cover layer is removed and replaced with a clean cover layer.

[0038] In another aspect of the invention, the device as defined in any of above is provided, wherein the disposable cover layer is formed from a polyurethane, polyisoprene, or latex.

[0039] In another aspect of the invention, the device as defined in any of above is provided, wherein the disposable cover layer comprises an absorbent three-dimensional lining and occlusive protective cover.

[0040] In another aspect of the invention, the device as defined in any of above is provided, wherein the disposable cover layer further comprises a conductive hydrogel; the conductive hydrogel comprising a three-dimensional structure to enable coupling with at least one electrode configured for electrical stimulation of a pudendal nerve or surrounding perianal tissue or both. In another aspect of the invention, the device as defined in any of above is provided, wherein the fecal blocking element is coated with a disposable non-soluble film to receive feces exiting the rectum during a fecal incontinence episode.

[0041] In another aspect of the invention, the device as defined in any of above is provided, wherein the fecal blocking element comprising a small aperture for the passage of gases. In another aspect of the invention, the device as defined in any of above is provided, wherein the fecal blocking element further providing tactile feedback by palpation for accurate positioning and placement of the device by the individual over the anal opening.

[0042] In another aspect of the invention, the device as defined in any of above is provided, further comprising a perineum absorbent patch or pad.

[0043] In another aspect of the invention, the device as defined in any of above is provided, wherein the substrate is coupled to at least one electrode configured for electrical stimulation of the S2-S3 dermatomes or surrounding perianal tissue or both; the at least one electrode positioned unilaterally to the substrate.

[0044] In another aspect of the invention, the device as defined in any of above is provided, wherein the rigid or semi-rigid support structure providing maximum proximal interface between the at least one electrode and skin surface of the individual; the maximum proximal interface providing increased transmission of electrical stimulation with lower resistance for a prolonged period of time.

[0045] In another aspect of the invention, the device as defined in any of above is provided, wherein the at least one electrode comprising at least two electrodes; the at least two electrodes positioned symmetrically about a midline of the substrate.

[0046] In another aspect of the invention, the device as defined in any of above is provided, wherein the electrodes are screen printed electrodes (SPEs).

[0047] In another aspect of the invention, the device as defined in any of above is provided, wherein the at least one electrode is coupled to a control module; the control module comprising a microprocessor for controlling operational parameters of the electrical stimulation or electrical activity measurement.

[0048] In another aspect of the invention, the device as defined in any of above is provided, wherein the rectal portion comprising a non-absorbent hollow structure, and an absorbent three-dimensional fecal blocking element; the hollow structure is formed from a silicone or another general-purpose synthetic elastomer; the buttocks support portion comprising a perforated hydrophobic carrier with skin adhesive, an absorbent three-dimensional lining and occlusive protective lining. In another aspect of the invention, the device as defined in any of above is provided, wherein the rectal portion comprising an absorbent hollow structure, and an absorbent three-dimensional fecal blocking element; the buttocks support portion comprising a perforated hydrophobic carrier with skin adhesive, an absorbent lining and occlusive cover.

[0049] In another aspect of the invention, the device as defined in any of above is provided, wherein the rectal portion comprising a non-absorbent structure; the non-absorbent structure is formed from a silicone or another general-purpose synthetic elastomer; the buttocks support portion comprising a perforated hydrophobic carrier with skin adhesive, an absorbent lining and occlusive cover. In another aspect of the invention, the device as defined in any of above is provided, further comprising a conductive hydrogel; the conductive hydrogel comprising a three-dimensional structure to enable coupling with at least one electrode configured for electrical stimulation of a pudendal nerve or surrounding perianal tissue or both.

[0050] In another aspect of the invention, the device as defined in any of above is provided, wherein the rectal portion comprising a therapeutic coating to facilitate a drug slow -release system; the drug slow-release system delivering a bioactive compound to an individual; the bioactive compound is a drug, pain reliever, antibiotic, anti-inflammatory, nanoparticle, or growth factor.

[0051] In another aspect of the invention, the device as defined in any of above is provided, wherein the rectal portion comprising an irrigation platform; the irrigation platform comprising fluid injection through the hollow structure formed from a silicone or another general -purpose synthetic elastomer; the fluid injection is directed into the lower bowel by way of the rectum; the fluid injection stimulating the emptying of the lower bowel of an individual.

[0052] In another aspect of the invention, the device as defined in any of above is provided, wherein the rectal portion comprising accessible absorbent lining; the absorbent lining is removed after a fecal incontinence episode and replaced with new absorbent lining using an attachment / detachment aid; the attachment / detachment aid adapted to receive and detachably secure one finger or two fingers for application and removal of the absorbent lining from the intergluteal cleft of the individual.

[0053] In another aspect of the invention, the device as defined in any of above is provided, wherein the attachment / detachment aid adapted to receive and detachably secure one finger for accurate positioning, placement and removal of the device from the intergluteal cleft of the individual. In another aspect of the invention, the device as defined in any of above is provided, wherein the attachment / detachment aid adapted to receive and detachably secure two fingers for accurate positioning, placement and removal of the device from the intergluteal cleft of the individual.

[0054] In another aspect of the invention, the device as defined in any of above is provided, wherein the substrate comprising a plurality of Velcro bands attached to the substrate, whereby the Velcro and the substrate jointly serve to: a. link between the first side portion and second side portion of the buttocks support portion during usage of the device; and b. secure the folding of the rigid or semi-rigid support structure of the device during usage to: i. enhance the mechanical forces generated by the arch’s keystone blocking element; and ii. provide discrete and hygienic concealment of soiling in the used device prior to disposal of the removable component with the absorbent lining after a fecal incontinence episode of the individual.

[0055] In another aspect of the invention, the device as defined in any of above is provided, wherein the buttocks support portion comprising a rigid or semi-rigid support structure, at least one adhesive layer, and a larger portion of flexible and stretchable material against a skin surface of the individual.

[0056] In another aspect of the invention, the device as defined in any of above is provided, wherein the device is assembled in a way enhancing movement of the substrate against the skin during activity of the individual; the movement providing mechanical stimuli of the anus; the stimuli of the anus facilitating bowel movements.

[0057] In another aspect of the invention, the device as defined in any of above is provided, wherein the substrate has a saddle shape and the rectal portion is curved for placement in an anus of the individual.

[0058] In one aspect of the invention, a device for treatment of pelvic floor disorders (PFDs) in an individual in need thereof, characterized by a multi-layer substrate with: a. a rectal portion, comprising a fecal blocking element; interconnected with b. a buttocks support portion, comprising flexible members with rigid ribs and at least one adhesive layer on the proximal side of the substrate configured to face a buttocks skin surface of the individual; and c. a perineum absorbent patch or pad.

[0059] In one aspect of the invention, a device for treatment of an overactive bladder (OAB) in an individual in need thereof, characterized by a multi-layer substrate with: a. a rectal portion, comprising a fecal blocking element; interconnected with b. a buttocks support portion, comprising flexible members with rigid ribs and at least one adhesive layer on the proximal side of the substrate configured to face a buttocks skin surface of the individual; and c. a perineum absorbent patch or pad.

[0060] In one aspect of the invention, a device for treatment of stress urinary incontinence (SUI) in an individual in need thereof, characterized by a multi-layer substrate with: a. a rectal portion, comprising a fecal blocking element; interconnected with b. a buttocks support portion, comprising flexible members with rigid ribs and at least one adhesive layer on the proximal side of the substrate configured to face a buttocks skin surface of the individual; and c. a perineum absorbent patch or pad.

[0061] In one aspect of the invention, a device for treatment of urge urinary incontinence (UUI) in an individual in need thereof, characterized by a multi-layer substrate with: a. a rectal portion, comprising a fecal blocking element; interconnected with b. a buttocks support portion, comprising flexible members with rigid ribs and at least one adhesive layer on the proximal side of the substrate configured to face a buttocks skin surface of the individual; and c. a perineum absorbent patch or pad.

[0062] In another aspect of the invention, the device as defined in any of above is provided, wherein the multi-layer substrate has a cross-sectional shape that is substantially in the form of an "eight, " such that the multi-layer substrate includes a central portion and two interconnected, opposing first and second loops, each loop being formed to conform to the anatomical contours of the individual’s intergluteal cleft, buttocks and perineum, providing a secure fit and enhanced sealing of the device during use.

[0063] In one aspect of the invention, a device for treatment of incontinence in an individual in need thereof, comprising a substrate characterized by a garment designed as underwear or panties; the garment comprising a fecal blocking element and a perineum absorbent patch or pad; the perineum absorbent patch or pad treating vaginal secretion and urinary incontinence.

[0064] In another aspect of the invention, the device as defined in any of above is provided, wherein the electrodes are wireless electrodes; the wireless electrodes coupled to the control module via at least one of a Bluetooth connection, an infrared connection, and a wireless local area network connection.

[0065] In another aspect of the invention, the device as defined in any of above is provided, wherein the control module is external to the substrate and coupled to at least one electrode with an electric cord or printed lead or another general-purpose coupling mechanism.

[0066] In another aspect of the invention, the device as defined in any of above is provided, wherein the electric cord or printed lead is integrated into an elongated adhesive patch of the substrate and connected to the control module.

[0067] In another aspect of the invention, the device as defined in any of above is provided, wherein the electric cord or printed lead exits the substrate through the posterior center buttocks of the individual and connects to the control module.

[0068] In another aspect of the invention, the device as defined in any of above is provided, wherein the electric cord or printed lead exits the substrate through the anterior thigh of the individual and connects to the control module.

[0069] In another aspect of the invention, the device as defined in any of above is provided, wherein the control module is attached with a clip on the clothing of the individual.

[0070] In another aspect of the invention, the device as defined in any of above is provided, wherein the control module is attached with a snap component and disposable adhesive patch to the clothing of the individual.

[0071] In another aspect of the invention, the device as defined in any of above is provided, wherein the control module is attached to an integrated elastic belt of the individual. In another aspect of the invention, the device as defined in any of above is provided, wherein the electric cord or printed lead is connected to the control module near the control module; the electric cord or printed lead is part of the device.

[0072] In another aspect of the invention, the device as defined in any of above is provided, wherein the electric cord or printed lead is connected at some distance from the control module to an extension cord from the control module; the electric cord or printed lead is part of the device; the extension cord is part of the control module.

[0073] In another aspect of the invention, the device as defined in any of above is provided, wherein the electric cord or printed lead is part of the control module; the electric cord or printed lead is connected to the device near the device.

[0074] In another aspect of the invention, the device as defined in any of above is provided, wherein the electric cord or printed lead is connected at some distance from the control module to an extension cord from the control module; the electric cord or printed lead 168 is part of the device; the extension cord is detachable from the control module.

[0075] In another aspect of the invention, the device as defined in any of above is provided, wherein the control module further comprising a button configured to activate on-demand, short duration electrical stimulation upon urge; the electrical stimulation activation can be combined with voluntary contraction of sphincter muscles; the combination of electrical stimulation and voluntary contraction of sphincter muscles can be sustained for a predetermined time period and repeated sequentially until the urge sensation is dismissed.

[0076] In another aspect of the invention, the device as defined in any of above is provided, wherein the control module is further configured to deliver continuous, sub-threshold electrical stimulation; the electrical stimulation acts as a transcutaneous neuromodulation of the sacral nerves through the S2-S3 dermatomes.

[0077] In another aspect of the invention, the device as defined in any of above is provided, wherein the control module is attached to the substrate.

[0078] In another aspect of the invention, the device as defined in any of above is provided, wherein the control module is coupled to at least one sensor in a control feedback loop.

[0079] In another aspect of the invention, the device as defined in any of above is provided, wherein the at least one sensor obtaining measurements associated with muscle activity or neurological activity or both; the at least one sensor selected from the group consisting of an electromyography (EMG) sensor, an impedance sensor, a capacitance sensor, a wetness sensor, a pH sensor, a temperature sensor, and a position sensor.

[0080] In another aspect of the invention, the device as defined in any of above is provided, wherein the measurements are reported to the patient or physician and used to: a. predict fecal incontinence frequency and patterns; b. adjust diet, prescription drugs and day-to-day behaviors; and c. regulate electrical stimulation properties or any other medical treatment.

[0081] In another aspect of the invention, the device as defined in any of above is provided, wherein the measurements are used to predict defecation and to activate electrical stimulation autonomically. In another aspect of the invention, the device as defined in any of above is provided, wherein the measurements are used to determine the optimal electrical stimulation patterns to achieve continence using machine learning algorithms.

[0082] In one aspect of the invention, a method for treating fecal incontinence in an individual in need thereof, characterized by the steps of: a. affixing device externally against a skin surface of an individual; the device comprising a multi-layer substrate with a rectal portion and a buttocks support portion; the rectal portion comprising a high-absorbency fill component or fecal blocking element; the buttocks support portion comprising flexible portions with rigid or semi-rigid portions; the flexible portions comprising a center portion, a first side portion and a second side portion on an opposite side with at least one adhesive layer with removable liner on the proximal side of the substrate to be fixed against a skin surface of an individual; b. restricting feces from an episode of fecal incontinence with the high-absorbency fill component or blocking element preventing leakage of feces; c. retaining feces in the rectal portion with an impermeable cover layer until removal and disposal; d. disposing retained feces in the rectal portion with the removable absorbent lining; and e. optionally, replacing disposed absorbent lining with new absorbent lining in the device.

[0083] In another aspect of the invention, the method above is provided, wherein the removable liner of the at least one adhesive layer used for packaging and easy placement and application of the device comprising steps of: a. removing the removable liner covering the adhesive layer of the center portion for positioning and placement of the rectal portion; and b. removing the removable liners covering the adhesive layers of the first side portion and the second side portion enabling full contact of the adhesive layers when affixing the device against the skin surface of an individual.

[0084] In another aspect of the invention, the method as defined in any of above is provided, wherein the multi-layer substrate is coupled to at least one electrode configured for electrical stimulation of the S2-S3 dermatomes or surrounding perianal tissue or both; the at least one electrode positioned unilaterally to the substrate.

[0085] In another aspect of the invention, the method as defined in any of above is provided, wherein immediate improvement in contraction of anal sphincter and pelvic floor muscles is achieved through the delivery of on-demand, acute electrical stimulation accompanied by voluntary contraction, resulting in dismissal of urge sensation and incontinence.

[0086] In another aspect of the invention, the method as defined in any of above is provided, wherein the on demand, acute electrical stimulation is triggered by the individual upon an urge sensation or following a signal received from at least one sensor obtaining measurements associated with muscle activity or neurological activity or both, predicting oncoming urge; the at least one sensor selected from the group consisting of an electromyography (EMG) sensor, an impedance sensor, a capacitance sensor, a wetness sensor, a pH sensor, a temperature sensor, and a position sensor. In another aspect of the invention, the method as defined in any of above is provided, wherein improvement over time in contraction of anal sphincter and pelvic floor muscles is achieved through the repeated delivery of on-demand, acute stimulation accompanied by voluntary contraction, resulting in muscle reinforcement and strengthening In another aspect of the invention, the method as defined in any of above is provided, wherein improvement in fecal incontinence conditions is achieved through the delivery of continuous, sub-threshold stimulation, to: a. provide neuromodulation of the sacral reflex pathways that control both the anal and bladder sphincters; b. improve muscle resting tone and overtime; and c. increase size and number of muscle fibers.

[0087] In one aspect of the invention, a method for treating fecal incontinence using a multimodal therapy, wherein at least one of the following members of a group is held true: a. providing a multi-layer substrate for: i. easy positioning adjacent to the anal region as a barrier and mechanical support; ii. easy application and removal; and iii. prolonged use to reduce urge sensation and fecal incontinence episodes; b. delivering short-duration stimulation (upon urge) for on-demand immediate dismissal of urge sensation, optionally combined with voluntary contraction to improve squeezing pressures and activate anal reflex, which can be used repeatedly over time to strengthen anal sphincter muscles and enhance voluntary control over defecation and urination; c. providing continuous background stimulation below sensory threshold for: i. neuromodulation of the sacral reflex pathways that control both the anal and bladder sphincters; ii. improvement of muscle resting tone; and iii. increase in size and number of muscle fibers over time; and d. providing personalized and customized approach to continence management using EMG and other biofeedback modalities. BRIEF DESCRIPTION OF THE DRAWINGS

[0088] The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:

[0089] Figure 1 is an illustration of a device for treatment of fecal incontinence, according to a specific embodiment of the present invention.

[0090] Figure 2 is an illustration of a device for treatment of fecal incontinence, in accordance with a specific embodiment of the present invention.

[0091] Figure 3 is an illustration of a device for treatment of fecal incontinence, in accordance with yet another embodiment of the present invention.

[0092] Figure 4 is an illustration of a device for treatment of fecal incontinence, in accordance with a further embodiment of the present invention.

[0093] Figure 5 is an illustration of an attachment / detachment aid with tactile alignment enabling accurate positioning or removal of a device, in accordance with a specific embodiment of the present invention.

[0094] Figure 6 is an illustration of an attachment / detachment aid with two-finger alignment enabling accurate positioning or removal of a device, in accordance with yet another embodiment of the present invention, in accordance with a specific embodiment of the present invention.

[0095] Figure 7 illustrates different variations of attachment / detachment aids with both tactile and two- finger alignment, in accordance with different embodiments of the present invention.

[0096] Figure 8 is an illustration of the multi-layer assembly models of an attachment / detachment aid, in accordance with a non-limiting embodiment of the present invention.

[0097] Figures 9A-B are simplified illustrations of an aspect of the device, in accordance with nonlimiting embodiments of the present invention.

[0098] Figures 10A-B are simplified illustrations of another aspect of the device, in accordance with nonlimiting embodiments of the present invention.

[0099] Figures 11A-C are simplified illustrations of yet another aspect of the device, in accordance with non-limiting embodiments of the present invention.

[0100] Figures 12A-C is a simplified illustration of an aspect of the device according to a specific embodiment of the present invention. Figure 13 is a simplified illustration of an aspect of the device, in accordance with a non-limiting embodiment of the present invention.

[0101] Figures 14A-C are simplified illustrations of affixing a device by a user according to a specific embodiment of the present invention.

[0102] Figures 15A-C are simplified illustrations of affixing a device by a user according to another specific embodiment of the present invention.

[0103] Figures 16A-B are simplified illustrations of affixing a device by a user according to a further specific embodiment of the present invention.

[0104] Figure 17 is a simplified illustration of an aspect of the device according to a specific embodiment of the present invention.

[0105] Figure 18 is a simplified illustration of an aspect of the device, in accordance with non-limiting embodiments of the present invention.

[0106] Figure 19 is an illustration showing a cross-section side view of the device according to a specific embodiment of the present invention.

[0107] Figure 20 is another illustration showing a cross-section side view of the device, according to a specific embodiment of the present invention.

[0108] Figure 21 is a simplified illustration of another aspect of the device according to a specific embodiment of the present invention.

[0109] Figure 22 is an illustration showing a cross-section side view of the device according to another specific embodiment of the present invention.

[0110] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0111] For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the figures and specific language will be used to describe the same. While examples and features of disclosed principles are described herein, modifications, adaptations, and other implementations are possible without limitation of the scope of the disclosed embodiments. Any further applications of the principles as described herein are contemplated as would normally occur to one skilled in the art.

[0112] This disclosure employs open-ended permissive language, indicating for example, that some embodiments “may” employ, involve, or include specific features. The use of the term “may”, and other open-ended terminology is intended to indicate that although not every embodiment may employ the specific disclosed feature, at least one embodiment employs the specific disclosed feature.

[0113] Reference will now be made in detail to non -limiting embodiments of this disclosure, embodiments of which are illustrated in the accompanying images. The embodiments are described below by referring to the figures, wherein like reference numerals refer to like elements. When similar reference numerals are shown, corresponding description(s) are not repeated, and the interested reader is referred to the previously discussed figure(s) for a description of the like element(s). As used throughout this description, the word “proximal” means situated nearer to the skin of the body or the point of attachment of the device in the present disclosure. The word “distal” means situated away from the skin of the body or from the point of attachment of the device in the present disclosure. The words "time period" mean the length of time during which an activity occurs or a condition remains, being at least 2 seconds in length.

[0114] Various embodiments are described herein with reference to a device or method. It is intended that the disclosure of one is a disclosure of all. For example, it is to be understood that disclosure of a device described herein also constitutes a disclosure of methods implemented by the device, via, for example, at least one electrode. It is to be understood that this form of disclosure is for ease of discussion only, and one or more aspects of one embodiment herein may be combined with one or more aspects of other embodiments herein, within the intended scope of this disclosure.

[0115] Described here is a device and method to treat fecal incontinence. This device, and its variations, are generally sized and configured to be placed at least partially within the intergluteal cleft (i.e., between the buttocks) and near the anus. In some embodiments, the device may include one or more features or may otherwise be configured to help positioning and placement in the correct location, and to minimize the risk of displacement or dislodgement of the device (such as, for example, during movement of the user or during sport activities such as walking).

[0116] The device, and its described variations, are generally configured as a substantially flat substrate having a proximal body -facing surface and a distal rear surface opposite the body-facing surface. When placed and secured in the intergluteal cleft, the device may be folded in a manner providing sealing at all times, while matching the curvatures of the anatomy. Generally, the device 100 may be comprised of a multi-layer substrate with a rectal portion 10 and a buttocks support portion 12. The rectal portion 10 comprising a fecal blocking element 14, and the buttocks support portion 12 comprising flexible portions with rigid or semi-rigid portions 19 and at least one adhesive layer on its proximal side against a skin surface of a user. For example, the parts on the proximal side that fit tight to the anus may be soft and flexible, whereas the buttocks supporting portions may be more rigid. The substrate of the device may have a thickness, which may at least partially depend on the number of layers. For example, in some variations the substrate may comprise a plurality of layers, such as a skin adhesive 38, an absorbent lining 40 and occlusive protective lining 42.

[0117] In some embodiments, the flexible portions of the buttocks support portion 12 may comprise a center portion, a first side portion and a second side portion on an opposite side with one or more adhesive layers. The one or more adhesive layers may adhere to the skin of the user (e.g., skin of the buttocks) to help maintain the placement and anchoring of the device. The adhesive layers may consist two adhesive layer types, including a light skin adhesive sheet 16 and medium or strong skin adhesive sheet 17.

[0118] In some embodiments, the rigid or semi-rigid support structure 19 may have higher hardness than the rectal portion, flexible portions and the adhesive layers. The support structure 19 may be formed from a plastic or a metal or another general-purpose hard material. The shape of the support structure may include a center portion, a first side portion with ribs 45 arching outward and away from the center portion on one side, and a second side portion with ribs 45 arching outward and away from the center portion on an opposite side. The support structure 19 comprising reinforcement ribs 45 may be arranged in a symmetrical fan-like manner emanating from the center portion and cushioned in an adhesive foam layer 21 to prevent direct contact with the skin of a user. Additionally, the support structure 19 supports the elastomer fecal blocking element 14 at two critical points: the anterior 15 and posterior 37 points, so as to prevent any leakage of feces to the front or rear of the device. In any case of feces leakage, it is thus directed laterally towards the adhesive layers of the substrate. The elastomer fecal blocking element 14 may have a small aperture 18 to allow the passage of gases released by a user and prevent its accumulation between the fecal blocking element 14 and anal opening. The small aperture 18 may also provide good air permeability and water vapor permeability. Generally, the fecal blocking element may have any suitable size and shape. For example, the fecal blocking element may have a circular shape, an oval shape, a dome shape, a rectangular shape, a lobed shape (e.g., a butterfly shape), or the like. Elements of the fecal blocking element 14 can act as a thin membrane to further provide tactile feedback by palpation of the rectum through the elastomer or plastic element, thus enabling accurate positioning and placement of the device by the user over the anal opening.

[0119] The rigid or semi-rigid support structure 19 or element of the present disclosure, and its variations, are novel and inventive by enabling several significant features not provided by any reasonable understanding of the prior art or combination thereof. Firstly, it allows easy application and placement of the device near the anal opening of the user. The use of the rigid or semi-rigid characteristics of the support structure, particularly its column strength, enable it to serve as an applicator. Secondly, its structure applies a plurality of forces, such as will be described in more detail below, when positioned and placed correctly within the intergluteal cleft (i.e., between the buttocks). When using the device, the rigid or semi-rigid support system 19 may be folded in the shape of an arch. The arch’s “keystone” becomes a stable structure press against the anus and to create mechanical closure or damming of the tissue surrounding the anal cavity. Thirdly, the reinforcement ribs 45 of the rigid or semi-rigid support structure 19 may provide additional functionality by conveying axial forces to the adhesive layers, thus a) preventing undesirable peeling of the adhesive layers unintentionally when applied by the feces coming out of the rectum; the unintentional peeling mechanism is entirely avoided by transforming axial forces acting on the rigid or semi-rigid element to shear forces acting on the adhesive layers; the adhesive layers can better tolerate shear forces (axial) compared to peeling forces (perpendicular), and b) allowing peeling of the entire area of the adhesive layers when intentionally applying sufficient force for detachment. Lastly, the rigid or semi-rigid structure makes an easy handling of the device after use, by allowing easy folding of the two side portions of the device inwards, subsequently concealing the residues of the feces inside the device structure. In summary, buckling of the rigid or semi-rigid element is prevented by the reinforcement of the adhesive layers adhering to the skin. The adhesive layers, in turn, are reinforced by the rigid or semi-rigid rib elements 45, thus preventing an unintentional peeling effect. Both elements synergistically operate to prevent expulsion of feces from the device.

[0120] In certain embodiments of the present disclosure, when affixing the device within the intergluteal cleft and near the anus, compressive radial force may be applied to each side of the rigid or semirigid support structure in order to fold it in the shape of a symmetrically folded arch. Once folded and positioned correctly, longitudinal, tangent forces are directed towards the anal opening on the rectal side while the adhesive layers transmit the forces into a form of shear forces 27 applied between the adhesive layers to the skin. The device of the present disclosure provides that these types of forces are easily contained by these types of adhesive layers. An absence of the rigid or semi-rigid ribs 45 would transform the forces applied by expulsion of the feces 39 from the rectum into peeling forces that such adhesives would not be able to hold. Subsequently, the entire adhesive layer in contact with the skin surface works together against disassembly of the device and prevents undesirable detachment. All of the abovementioned axial forces vs. shear forces are substantial, such that they cause the substrate of the device to be fixed securely and efficiently sealed against the skin of a user. The abovementioned applied forces also enable angle tilting that occurs when a device shifts to be avoided. Generally, buckling mechanism is a mode of failure that is avoided by the combination of the rigid or semi-rigid ribs 45 and adhesive layers. Buckling effect is avoided latterly 25 by the strong cross-sectional moment of inertia in that direction. Additionally, buckling effect is avoided in the direction normal to skin 41 by the adhesive layer that secures the rigid or semi-rigid ribs 45 to the skin.

[0121] In another embodiment, for which electrodes are incorporated within the device, on the proximal side and facing the skin, the abovementioned secure contact with skin surface guarantees better transmission of electrical stimulation with lower resistance for a prolonged period of use time. During an episode of fecal incontinence of a user, the feces may be retained by the device comprising two barriers. In the first barrier, the feces may be restricted with a high-absorbency fill component or blocking element of the rectal portion of the device. In the second barrier, the feces may be restricted by the adhesion strength of the adhesive layers.

[0122] The device described here may be worn while presenting little or no visual indication of use by the user. It may be of a sufficiently small size such that replacements of the absorbent lining may be discreetly carried by a wearer (e.g., in a pocket or purse). Furthermore, the absorbent lining may be configured with an attachment / detachment aid adapted to receive and detachably secure one or more fingers for accurate positioning, placement and retrieval in a manner saving users from reaching into the intergluteal cleft or otherwise soil their fingers. Accordingly, the attachment / detachment aid described here may present tactile 54 or two-finger alignment 62. In certain embodiments, the substrate may include, without limitation, a means to link between the two sides such as with plurality of Velcro bands attached to it, whereby the Velcro and substrate jointly serve to secure the folding of the device for increased functionality. Firstly, the secure folding may enhance the mechanical forces generated by the arch’s keystone blocking element. Secondly, secured folding of the device may provide a clean and hygienic way to conceal soiling in the used device prior to disposal of the removable component with absorbent lining after a fecal incontinence episode of a user. Once removed and disposed, a user may replace the device with new absorbent lining.

[0123] In accordance with a non-limiting embodiment of the present invention, the substrate may include one or more electrodes configured for transcutaneous stimulation of the pudendal nerve or the surrounding perianal tissue (skin, fat and muscle) or both, thereby raising the pressure of the anal canal and contracting the external anal sphincter or creating neuromodulation. Nonlimiting operational parameters of the electrodes include current, pulse width, pulse frequency, pulse interval, and others. Without limitation, appropriate use of the electrodes include stimulation and / or sensing such as TENS (transcutaneous electrical nerve stimulation), EMS (electrical muscle stimulation), FES (functional electrical stimulation), ECG (electrocardiogram), Impedance measurements and EMG (electromyography). Electrodes can be skin electrode pads and / or in screen printed electrodes (SPEs) form.

[0124] In some embodiments, there are at least two electrodes, whilst each electrode may be mounted on substrate by any joining method, such as but not limited to, sewing, bonding, mechanical fasteners and many more. Additionally, the electrodes may be covered by a layer of conductive hydrogel. The electrodes may be symmetrically placed about a midline of a substrate, thus including a left electrode 11 and a right electrode 13, or positioned at any place around the rectum, sacrum area or gluteal muscles. In certain embodiments, the electrodes coupled to the substrate are shortened and act as one electrode against another electrode which may be located elsewhere (such as a skin electrode located above the sacrum area).

[0125] In certain embodiments, the rectal portion may comprise a conductive hydrogel 20, a nonabsorbent hollow structure 22, and an absorbent three-dimensional fecal blocking element 24. The hollow structure 22 may be formed from a silicone, providing tactile feedback for accurate positioning and placement of the device over the anal opening by the user. The buttocks support portion comprising a perforated hydrophobic carrier with skin adhesive 26, an absorbent three- dimensional lining 28 and occlusive protective lining 30.

[0126] In other embodiments, the rectal portion may comprise a conductive hydrogel 32, an absorbent hollow structure 34, and an absorbent three-dimensional fecal blocking element 36, which may be utilized for tactile feedback for accurate positioning and placement of the device over the anal opening. The buttocks support portion comprising a perforated hydrophobic carrier with skin adhesive 38, an absorbent lining 40 and occlusive cover 42.

[0127] In further embodiments, the rectal portion may comprise a conductive hydrogel 44 and a nonabsorbent structure 46. The non-absorbent structure may be formed from a silicone, used for tactile feedback for accurate positioning and placement of the device, while the buttocks support portion comprising a perforated hydrophobic carrier with skin adhesive 48, an absorbent lining 50 and occlusive cover 52.

[0128] In some embodiments, the rectal portion comprises a therapeutic coating to facilitate a slow- release drug release system, supported by the fact the anus is blocked by the blocking element. Hydrogels are a particularly appealing type of drug delivery system, and have been used in many branches of medicine, including cardiology, oncology, immunology, wound healing, and pain management. Due to the high-water content and cross-linked polymer network of hydrogels, they provide excellent biocompatibility and the capability to easily encapsulate hydrophilic drugs. Moreover, their cross-linked network can impede penetration of various inwardly diffusing enzymes, thus protecting bioactive therapeutics from premature degradation. Without limitation, suitable hydrogels include those fabricated from synthetic polymers such as poly(vinyl alcohol) and poly(hydroxyl alkyl methacrylate), and biopolymers such as alginate, collagen and chitosan. These hydrogels may be used for transdermal drug delivery of proteins, such as insulin and calcitonin. In general, the drug release system may deliver a bioactive compound to a user, such as a drug, pain reliever, antibiotic, anti-inflammatory, nanoparticle or growth factor. This controlled release of bioactive compounds leads to important advantages as a control of the biodisponibility, dose control, local delivery and less side effects.

[0129] In further embodiments, the rectal portion comprises an irrigation platform for enema therapy, which comprises fluid injection through the silicone hollow structure. The fluid injection is directed into the lower bowel by way of the rectum, thereby stimulating the emptying of the lower bowel of a user. In general, transanal irrigation encompasses the use of enema therapy to intermittently empty the rectum and distal colon with the aim of avoiding episodes of fecal incontinence. As such, this therapy has been shown to have the highest utility in patients suffering from fecal incontinence, secondary to primary constipation.

[0130] In some embodiments, the buttocks support portion of the device substrate comprises a larger portion of flexible and stretchable material with less adhesive layer against a skin surface of a user, as well as a rigid or semi-rigid supportive structure, without a rectal closure element. Walking and mild physical activity of an individual wearing the device in the present disclosure may potentially stimulate peristalsis and enhance stimulation of the anal area, thus facilitating bowel function and subsequently promoting defecation.

[0131] In other embodiments, the substrate of the device is comprised as a garment designed as underwear or panties. The garment may include a fecal blocking element or a perineum absorbent patch or pad for treating vaginal secretion or urinary incontinence, or both. Urinary incontinence is a loss of bladder control, often leading to uncontrollable urine leakage. There are four types of urinary incontinence: urgency, stress, functional and overflow incontinence. The device presented in the present disclosure provides a discreet and non-invasive device for people suffering from urinary incontinence.

[0132] In further embodiments, the control module of the device may have a button to activate electrical stimulation upon urge, which may be combined with voluntary contraction of the sphincter muscles. The combination of electrical stimulation and voluntary contraction of sphincter muscles may be sustained for a predetermined time period and repeated sequentially until said urge sensation is dismissed. The predetermined time period may be selected from, but not limited to, a group consisting of two seconds, five seconds, ten seconds, twenty seconds and thirty seconds.

[0133] Reference is now made to Fig. 1 , which shows a top view illustration of the proximal side of a device for treatment of fecal incontinence, in accordance with a non-limiting embodiment of the present invention. The fecal blocking element 14 of the rectal portion 10 comprises a three- dimensional oval-shaped structure from an elastomer or a plastic over the anal opening. The fecal blocking element 14 may have a small aperture 18 to allow the passage of gases released by a user and provide good air permeability and water vapor permeability. The buttocks support portion 12 comprising at least two adhesive layer types with a light skin adhesive sheet 16 and medium or strong adhesive sheet 17. A rigid or semi-rigid supportive structure 19 is cushioned in an adhesive foam layer 21 to prevent direct contact with the skin. The device may include a left electrode 11 and a right electrode 13 configured for transcutaneous stimulation and / or electrical activity measurements and positioned symmetrically about a midline of the substrate, coupled to an external control module. Transcutaneous stimulation of the pudendal nerve or the surrounding perianal tissue (skin, fat and muscle) (or both) may contract the sphincter muscles and raise the pressure of the anal canal to contract the external anal sphincter. Non-limiting operational parameters of the electrodes include current, pulse width, pulse frequency, pulse interval, and others. Electrical activity measurements may include EMG or Impedance measurements.

[0134] Fig. 2 is an illustration of another device for treatment of fecal incontinence, in accordance with a non-limiting embodiment of the present invention. The device comprising a three-dimensional non-absorbent hollow dome 22 and absorbent lining 28. The rectal portion may comprise a conductive hydrogel 20, a non-absorbent hollow dome structure 22, and an absorbent three- dimensional fecal blocking element 24. The hollow dome structure 22 is formed from a silicone, whilst the buttocks support portion is comprising a perforated hydrophobic carrier with skin adhesive 26, an absorbent three-dimensional lining 28 and occlusive protective lining 30.

[0135] Fig. 3 is an illustration of another device for treatment of fecal incontinence, in accordance with a non -limiting embodiment of the present invention. The device may comprise a three-dimensional absorbent dome 36 and absorbent lining 40. The rectal portion may comprise a conductive hydrogel 32, an absorbent hollow dome structure 34, and an absorbent three-dimensional fecal blocking element 36. The buttocks support portion may comprise a perforated hydrophobic carrier with skin adhesive 38, an absorbent lining 40 and occlusive cover 42.

[0136] Fig. 4 is an illustration of another device for treatment of fecal incontinence, in accordance with a non -limiting embodiment of the present invention. The device may comprise a three-dimensional non-absorbent dome 46 and absorbent lining 50. The rectal portion may comprise a conductive hydrogel 44 and a non-absorbent dome structure 46. The non-absorbent dome structure 46 may be formed from a silicone, whilst the buttocks support portion is comprising a perforated hydrophobic carrier with skin adhesive 48, an absorbent lining 50 and occlusive cover 52.

[0137] Referring now to Figs. 5-8, which show illustrations of different embodiments of attachment / detachment aids adapted to receive and detachably secure one or two fingers for accurate positioning, placement and removal of the device from the intergluteal cleft of the user. In accordance with a non-limiting embodiment of the present invention, Fig. 5 is an illustration of an attachment / detachment aid with tactile alignment 54 comprising an application aid 56, top part (foam layer) 58 and bottom part 60.

[0138] Fig. 6 is an illustration of an attachment / detachment aid with two-finger alignment 62 comprising an application aid 64, top part (foam layer) 66 and bottom part 68, in accordance with a nonlimiting embodiment of the present invention.

[0139] In accordance with a non-limiting embodiment of the present invention, Fig. 7 illustrates different variations of attachment / detachment aids, including tactile alignment with finger hole joined with an elongation bar 54 or separate from an elongation bar 70, and two-finger alignment with joined finger holes 62 or separate finger holes 72.

[0140] Fig. 8 is an illustration of the multi-layer assembly of an attachment / detachment aid comprising an application aid 74, top part (foam layer) 76, middle part 78, bottom part 80 and silicone adhesive 82, in accordance with a non -limiting embodiment of the present invention, in accordance with a non -limiting embodiment of the present invention.

[0141] Fig. 9A is a simplified illustration of a device with three-dimensional fecal blocking element as shown in Figs. 2-4, in accordance with a non-limiting embodiment of the present invention. The cord 88 connected to the control module 84 exits the main device 86. Fig. 9B is a simplified illustration of a device 94 with three-dimensional fecal blocking element and elongated adhesive patch 92, which allows additional electrode location around the sacrum area as shown in Figs. 2-4, in accordance with a non-limiting embodiment of the present invention. The cord 90 connected to the control module 96 exits the elongated adhesive patch 92.

[0142] Fig. 10A is a simplified illustration of a device 101 as shown in Figs. 2-4, in accordance with a non-limiting embodiment of the present invention, wherein the cord 98 exits the back of the user through the center of the buttocks to connect with the control module 102. Fig. 1 OB is a simplified illustration of a device 106 as shown in Figs. 2-4, in accordance with a non-limiting embodiment of the present invention, wherein the cord 104 exits the front side of the user adjacent to the thigh to connect with the control module 108.

[0143] Fig. 11A is a simplified illustration of a device 108 as shown in Figs. 2-4, in accordance with a non -limiting embodiment of the present invention, wherein the cord 112 connects with the control module 114 which is attached with a clip 116 to clothing for docking. Fig. 1 IB is a simplified illustration of a device 118 as shown in Figs. 2-4, in accordance with a non-limiting embodiment of the present invention, wherein the cord 122 connects with the control module 124 which is attached with a snap component to a disposable adhesive patch 126 for docking. Fig. 11C is a simplified illustration of a device 128 as shown in Figs. 2-4, in accordance with a non-limiting embodiment of the present invention, wherein the cord 132 connects with the control module 134 which is attached with an integrated docking solution, e.g., elastic belt 136, independent of clothing.

[0144] Fig. 12A is a simplified illustration of a device as shown in Figs. 2-4, in accordance with a nonlimiting embodiment of the present invention, wherein the connector location is near the control module 144 and the cord 142 is a part of the disposable device 138. Fig. 12B is a simplified illustration of a device as shown in Figs. 2-4, in accordance with a non-limiting embodiment of the present invention, wherein the connector location is at some distance from the control module 152 having a long cord 154, and a short cord 150 is on the disposable device 146. Fig. 12C is a simplified illustration of a device as shown in Figs. 2-4, in accordance with a non-limiting embodiment of the present invention, wherein the connector location is on the disposable device 156 and the cord 160 is part of the control module 162.

[0145] Fig. 13 is a simplified illustration of a device as shown in Figs. 2-4, in accordance with a nonlimiting embodiment of the present invention. In the embodiment, there is an extension cord 168 connected to the disposable device 164 and a short cord 170 connected to the control module 172, wherein the connector location is at a distance from both.

[0146] Fig. 14A is a simplified illustration of a device as shown in Figs. 2-4, in accordance with a nonlimiting embodiment of the present invention, wherein the cord exits the back of the user through the center of the buttocks. Fig. 14B is a simplified illustration of the device shown in Fig. 14A when mounted upon a large waist size user. Fig. 14C is a simplified illustration of the device shown in Fig. 14A when mounted upon a thin waist size user.

[0147] Fig. 15 A is a simplified illustration of a device as shown in Figs. 2-4, in accordance with a nonlimiting embodiment of the present invention, wherein the cord exits the back side of the user adjacent to the thigh. Fig. 15B is a simplified illustration of the device shown in Fig. 15A when mounted above the thigh of a large waist size user. Fig. 15C is a simplified illustration of the device shown in Fig. 15A when mounted above the thigh of a thin waist size user.

[0148] Fig. 16A is a simplified illustration of a device as shown in Figs. 2-4, in accordance with a nonlimiting embodiment of the present invention, wherein the cord exits the front side of the user adjacent to the thigh. Fig. 16B is a simplified illustration of the device shown in Fig. 16A with a short cord, when mounted on the thigh of a user.

[0149] Figs. 17 is a simplified top view illustration of the proximal side of a rigid or semi-rigid support structure 19, in accordance with a non-limiting embodiment of the present invention. The hard material support structure 19 is formed from a high shore elastomer, a thin layer of plastic or a thin layer of metal, thus allowing higher column strength together with flexibility for folding, positioning and placement by a user. The fecal blocking element 14 of the rectal portion comprises a three-dimensional oval-shaped structure from an elastomer or a plastic. The rigid or semi-rigid structure supports the elastomer at critical points at the anterior 15 and posterior 37 sides when applied with pressure during a fecal incontinence episode of a user.

[0150] Fig. 18 is a simplified illustration of a rigid or semi-rigid support structure 19, in accordance with a non-limiting embodiment of the present invention. The illustration shows a top view of the rigid or semi-rigid support structure at an angle. The elastomer design contributes to pressure over anterior 15 and posterior 37 points without adhesive, particularly during a fecal incontinence episode of a user, thus preventing any leakage of fecal matter from the device. Fig. 19 is an illustration showing a cross-section side view of the device, in accordance with a non-limiting embodiment of the present invention, when placed by a user. The expulsion of feces from the rectum applies forces outward and away from the anal opening 39. The rigid or semirigid support structure 19 is folded into the shape of an arch within the intergluteal cleft and embedded in the adhesive layers of the substrate comprising a light adhesive layer 16 and a medium or strong adhesive layer 17. Buckling effect 25 is avoided laterally by the strong cross- sectional moment of inertia in that direction. Shear stress 27 arising from the shear forces are applied over the adhesive layers. The fecal blocking element 10 from elastomer or plastic is positioned directly on the anal opening, allowing the passage of gases 23, and supported at the anterior and posterior by the rigid or semi-rigid support structure 19 cushioned in an adhesive foam layer 21.

[0151] Fig. 20 is an illustration showing a cross-section side view of the device, in accordance with a non-limiting embodiment of the present invention, when placed at least partially within the intergluteal cleft. Once the rigid or semi-rigid support structure is folded in a V-shape and positioned at least partially within the intergluteal cleft of a user (i.e., between the buttocks) and near the anus, longitudinal, tangent forces are directed towards the anal opening and lateral forces are produced between the sides of the arch and tissue of the user, thus triggering longitudinal forces 43. The expulsion of the feces from the rectum applies forces outward and away from the anal opening 39. Lateral buckling effect 25 is avoided by the strong cross- sectional moment of inertia in that direction. Buckling effect is also avoided in the direction normal to skin 41 by the adhesive layers. Shear forces act in opposite directions on the first and second side portions with adhesive layers of the buttocks support portion. Subsequently, shear stress 27 arising from the shear forces are applied over the adhesive layers of the substrate, thus making an elongation effect. The adhesive layers, together with reinforcement ribs 45, effectively adhere to a substantial area of the skin surface of a user. As a result, the entire adhesive layer in contact with the skin surface works together against disassembly of the device, causing the substrate to be sealed and fixed securely against the skin of a user. Fig. 21 is an illustration of a top view of the proximal side of a device for treatment of fecal incontinence, in accordance with a non-limiting embodiment of the present invention. The expulsion of feces from the rectum, retained by the fecal blocking element 14 (first barrier), applies lateral forces 29 towards the pocket of light skin adhesive 16, which serves as a second barrier with the medium or strong adhesive sheet 17. Fig. 22 is a simplified illustration of another device without rigid layer effect, in accordance with another non-limiting embodiment of the present invention. The device may comprise an absorbent three-dimensional fecal blocking element 31 formed from silicone, which may provide tactile feedback for positioning and accurate placement of the device. Increased pressure from expulsion of the feces through the rectum during a fecal incontinence episode leads to silicon axial movement 33. The adhesive layer allows for easy pullaway peeling 35 when disposing and replacing the fecal blocking element.

[0152] CLINICAL DATA

[0153] Clinical trial 1: Characteristics of the population:

[0154] Overall, fourteen patients were screened and initiated the study procedures. The patients comprised twelve females and two males. The median age was 63 years [28,77], All patients had a clinical history of fecal incontinence of any degree in the past.

[0155] Primary endpoint: Demonstrate effect of acute stimulation to improve anal squeezing pressures. Results: Results showed that acute stimulation combined with voluntary squeezing demonstrates an improved squeezing / contraction compared to basslines for at least 80% of the patients. In addition, a learning effect was observed amongst the patients, i.e., pressure increase during voluntary squeeze post stimulation was better than the initial voluntary baseline squeeze. Figure 23 shows the squeezing pressure increase (mmHg) in patients 1 -6, whilst comparing baseline, stimulation and post stimulation stages of the study. Overall, the mean squeeze pressure (mmHg) increased by 42 percent compared to the baseline value, whereas the duration of the squeeze-hold (seconds) increased by 25 percent compared to the baseline.

[0156] Clinical trial 2: Patient Reported Outcomes (PROs)

[0157] In a second 10- weeks long trial, thirty patients were screened and initiated the study procedures. Initial results of three out of thirty patients, who accumulated 14 days using the device, showed significant reduction in the number of urge and incontinence episodes over treatment periods (Fig. 24). Figure 24 shows the reduction in the number of urge and incontinence episodes over treatment periods in patients 1-3 whilst comparing baseline, treatment and follow up stages of the study. All patients demonstrated a willingness to continue using the device, a reduction in fecal incontinence urge and incontinence, and an overall improvement in quality of life (QoL). EXAMPLES

[0158] Example 1 : Managing Fecal Incontinence in Adults

[0159] A 65-year-old woman, diagnosed with severe fecal incontinence due to age-related muscle weakening, struggles with maintaining cleanliness and dignity. She uses the device described in the present disclosure to help manage her condition. The woman applies the device around her anal opening, ensuring it fits securely within the intergluteal cleft. The rectal portion 10 containing the fecal blocking element 14 effectively prevents any fecal leakage. The flexible adhesive layers 16, 17 on the buttocks support portion 12 provide comfort while ensuring a tight and secure fit. The rigid support structure 19, with its reinforcement ribs 45, ensures that the device remains in place even when the user is active, such as walking or bending. This structure also directs forces from fecal expulsion into shear forces, preventing the adhesive from peeling off. After using the device for several days, the woman finds it to be effective in preventing leakage and offering her more confidence in her daily activities. She can easily remove the device when necessary, due to the structured design, and dispose of it without discomfort. Example 2: Post-Surgical Use for Colorectal Surgery Recovery

[0160] A 50-year-old man recovering from a colorectal surgery is advised by his doctor to use a device to manage mild fecal leakage while his body heals. The surgeon suggests the device of the present disclosure, effective in post-surgical care due to its unique combination of rigid support 19 and flexible components 10, 12. The patient applies the device in the same manner, positioning the fecal blocking element 14 snugly around the anal opening. The small aperture 18 in the fecal blocking element allows gas to escape without causing discomfort, which is especially important given the patient’s recovery. The rigid ribs 45 in the support structure help stabilize the device, preventing it from shifting or slipping during normal movements. The adhesive layers 38, 40, 42 ensure that the device stays in place without causing irritation to the skin, and the symmetrical folding 19 of the structure makes it easy to remove and replace after use. The patient finds that the device provides significant relief during his recovery by managing leakage and reducing the risk of further irritation or complications.

[0161] Example 3 : Use in Patients with Spinal Cord Injury A28-year-old male who has suffered a spinal cord injury resulting in neurogenic bowel dysfunction uses the device of the present disclosure, characterized by a closed loop mechanism, to manage fecal incontinence. Due to his inability to feel or control bowel movements, he requires a device that may identify an urge sensation or an oncoming urge from a signal received from at least one sensor (e.g., electromyography (EMG) sensor, an impedance sensor, a capacitance sensor, a wetness sensor, a pH sensor, a temperature sensor, and a position sensor) obtaining measurements associated with muscle activity or neurological activity or both. Then the device triggers acute electrical stimulation, resulting in dismissal of urge sensation and incontinence. Moreover, the device may contain fecal matter and prevent leakage while providing comfort during periods of prolonged sitting in a wheelchair. The patient places the device around the anal opening, where the flexible portions of the buttocks support 12 conform to the contours of his body. The rigid support structure 19, with its reinforcement ribs 45, helps prevent the device from shifting or buckling, even when he is seated for long periods. The adhesive layers 16, 17 ensure that the device remains securely in place, providing the necessary seal and preventing discomfort or skin irritation. The small aperture 18 in the fecal blocking element 14 allows for gas release, preventing uncomfortable buildup. He reports that the device offers consistent protection and comfort, enabling him to maintain his daily activities without worrying about leakage. It also gives him greater confidence in social / professional interactions. The description and illustration of one or more examples provided in this invention are not intended to limit or restrict the scope as claimed in any way. The aspects, examples, and details provided in this invention are considered sufficient to convey possession and enable others to make and use the best mode. Implementations should not be construed as being limited to any aspect, example, or detail provided in this invention. Regardless of whether shown and described in combination or separately, the various embodiments (both structural and methodological) are intended to be selectively included or omitted to produce an example with a particular set of embodiments. Having been provided with the description and illustration of the present invention, one skilled in the art may envision variations, modifications, and alternate examples falling within the spirit of the broader aspects of the general inventive concept embodied in this invention that do not depart from the broader scope. as walking or bending. This structure also directs forces from fecal expulsion into shear forces, preventing the adhesive from peeling off.

[0162] After using the device for several days, the woman finds it to be effective in preventing leakage and offering her more confidence in her daily activities. She can easily remove the device when necessary, due to the structured design, and dispose of it without discomfort.

[0163] Example 2: Post-Surgical Use for Colorectal Surgery Recovery

[0164] A 50-year-old man recovering from a colorectal surgery is advised by his doctor to use a device to manage mild fecal leakage while his body heals. The surgeon suggests the device of the present disclosure, effective in post-surgical care due to its unique combination of rigid support 19 and flexible components 10, 12.

[0165] The patient applies the device in the same manner, positioning the fecal blocking element 14 snugly around the anal opening. The small aperture 18 in the fecal blocking element allows gas to escape without causing discomfort, which is especially important given the patient’s recovery. The rigid ribs 45 in the support structure help stabilize the device, preventing it from shifting or slipping during normal movements. The adhesive layers 38, 40, 42 ensure that the device stays in place without causing irritation to the skin, and the symmetrical folding 19 of the structure makes it easy to remove and replace after use. The patient finds that the device provides significant relief during his recovery by managing leakage and reducing the risk of further irritation or complications.

[0166] Example 3: Use in Patients with Spinal Cord Injury

[0167] A28-year-old male who has suffered a spinal cord injury resulting in neurogenic bowel dysfunction uses the device of the present disclosure, characterized by a closed loop mechanism, to manage fecal incontinence. Due to his inability to feel or control bowel movements, he requires a device that may identify an urge sensation or an oncoming urge from a signal received from at least one sensor (e.g., electromyography (EMG) sensor, an impedance sensor, a capacitance sensor, a wetness sensor, a pH sensor, a temperature sensor, and a position sensor) obtaining measurements associated with muscle activity or neurological activity or both. Then the device triggers acute electrical stimulation, resulting in dismissal of urge sensation and incontinence. Moreover, the device may contain fecal matter and prevent leakage while providing comfort during periods of prolonged sitting in a wheelchair.

[0168] The patient places the device around the anal opening, where the flexible portions of the buttocks support 12 conform to the contours of his body. The rigid support structure 19, with its reinforcement ribs 45, helps prevent the device from shifting or buckling, even when he is seated for long periods. The adhesive layers 16, 17 ensure that the device remains securely in place, providing the necessary seal and preventing discomfort or skin irritation. The small aperture 18 in the fecal blocking element 14 allows for gas release, preventing uncomfortable buildup.

[0169] He reports that the device offers consistent protection and comfort, enabling him to maintain his daily activities without worrying about leakage. It also gives him greater confidence during social interactions and professional engagements.

[0170] The description and illustration of one or more examples provided in this invention are not intended to limit or restrict the scope as claimed in any way. The aspects, examples, and details provided in this invention are considered sufficient to convey possession and enable others to make and use the best mode. Implementations should not be construed as being limited to any aspect, example, or detail provided in this invention. Regardless of whether shown and described in combination or separately, the various embodiments (both structural and methodological) are intended to be selectively included or omitted to produce an example with a particular set of embodiments. Having been provided with the description and illustration of the present invention, one skilled in the art may envision variations, modifications, and alternate examples falling within the spirit of the broader aspects of the general inventive concept embodied in this invention that do not depart from the broader scope.

Claims

CLAIMS1. A device 100 for treatment of fecal incontinence in an individual in need thereof, characterized by a multi-layer substrate with: a. a rectal portion 10, comprising a fecal blocking element 14; interconnected with b. a buttocks support portion 12, comprising flexible members with rigid ribs 19 and at least one adhesive layer 16 on the proximal side of said substrate configured to face a buttocks skin surface of said individual.

2. The device 100 according to claim 1, wherein said rigid or semi-rigid portions comprising a rigid or semi-rigid support structure 19 with higher rigidity than said rectal portion, said flexible portions of said buttocks support portion, and said at least one adhesive layer; said support structure 19 formed from a high shore silicone or a plastic or a metal or another general -purpose hard material in a shape comprising: a. a center portion; b. a first side portion with at least one reinforcement rib 45 arching outward and away from the center portion on one side; and c. a second side portion with at least one reinforcement rib 45 arching outward and away from the center portion on an opposite side.

3. The device 100 according to claim 2, wherein said at least one reinforcement rib 45 embedded within said flexible portions and cushioned in an adhesive foam layer 21.

4. The device 100 according to claim 2, wherein buckling effect of said rigid or semi-rigid support structure 19 is prevented by the reinforcement of said at least one adhesive layer adhering to a skin surface; unintentional peeling effect of said at least one adhesive layer is prevented by the reinforcement of said rigid or semi-rigid support structure 19; said at least one adhesive layer and said rigid or semi-rigid support structure 19 synergistically operate to prevent expulsion of feces from said device.

5. The device 100 according to claim 2, wherein said at least one reinforcement rib 45 of said support structure comprising at least two reinforcement ribs 45; said at least two reinforcement ribs 45 comprising a plurality of reinforcement ribs 45; said plurality of reinforcement ribs 45 arranged in a symmetrical fan-like manner emanating from said center portion of said support structure 19.

6. The device 100 according to claim 5, wherein said at least two reinforcement ribs 45 or said plurality of reinforcement ribs 45 embedded within said flexible portions and cushioned in an adhesive foam layer 21.

7. The device 100 according to claim 1, wherein said flexible portions of said buttocks support portion 12 comprising: a. a center portion; b. a first side portion; and c. a second side portion on an opposite side with at least one adhesive layer on the proximal side of said substrate against a skin surface of an individual; said at least one adhesive layer comprising at least two adhesive layers; said at least two adhesive layers comprising two adhesive layer types; said two adhesive layer types comprising a light skin adhesive sheet 16 and medium or strong skin adhesive sheet 17.

8. The device 100 according to claim 1, wherein said at least one adhesive layer having at least one removable liner; said at least one removable liner covering said center portion, first side portion and second side portion of said flexible portions of said buttocks support portion 12.

9. The device 100 according to claim 2, wherein said rigid or semi-rigid support structure 19 having column strength enabling easy placement and application of said device by said individual by hardening said at least two adhesive layers, making each side portion a rigid body during placement.

10. The device 100 according to claim 2, wherein said rigid or semi-rigid support structure 19 comprising reinforcement ribs 45 conveying axial forces to said adhesive layers to: a. prevent undesirable peeling of said adhesive layers unintentionally when applied by the feces exiting the rectum; and b. allow peeling of entire area of said adhesive layers only when intentionally applying sufficient force for detachment.

11. The device 100 according to claim 2, wherein said rigid or semi-rigid support structure 19 folding in the shape of an arch when applying radial force during placement and application of said device near the anal opening; said arch’ s keystone achieving mechanical closure or damming of the tissue surrounding the anal cavity by applying forces comprising: a. tangential longitudinal forces towards the anal opening of said individual; and b. lateral forces between the side of said arch and tissue of said individual.

12. The device 100 according to claim 2, wherein said rigid or semi-rigid support structure 19 folding on itself by said individual after a fecal incontinence episode to allow discrete and hygienic disposal.

13. The device 100 according to claim 1, wherein said multi-layer substrate has a cross-sectional shape that is substantially in the form of an "eight," such that said multi-layer substrate includes a central portion and two interconnected, opposing first and second loops, each loop being formed to conform to the anatomical contours of said individual’s intergluteal cleft, buttocks and perineum, providing a secure fit and enhanced sealing of the device during use.

14. The device according to claim 13, wherein said first loop comprises a fecal blocking element and said second loop comprises a urinary blocking element.

15. The device 100 according to claim 1, wherein said fecal blocking element 14 of said rectal portion 10 comprising a three-dimensional component formed from an elastomer or a plastic; said component may have a shape selected from the group consisting of a circular shape, an oval shape, a dome shape, a rectangular shape, a lobed shape (e.g., a butterfly shape), a cone shape, a cylindrical shape, a spiral shape, a concave shape, a convex shape, a ball-headed shape, and the like.

16. The device 100 according to claim 15, wherein said fecal blocking element 14 is provided with a disposable cover layer configured to receive feces exiting the rectum during a fecal incontinence episode, after which said cover layer is removed and replaced with a clean cover layer.

17. The device 100 according to claim 16, wherein said disposable cover layer is formed from a polyurethane, polyisoprene, or latex.

18. The device 100 according to claim 16, wherein said disposable cover layer comprises an absorbent three-dimensional lining and occlusive protective cover.

19. The device 100 according to claim 16, wherein said disposable cover layer further comprises a conductive hydrogel; said conductive hydrogel comprising a three-dimensional structure to enable coupling with at least one electrode configured for electrical stimulation of a pudendal nerve or surrounding perianal tissue or both.

20. The device 100 according to claim 15, wherein said fecal blocking element 14 is coated with a disposable non-soluble film to receive feces exiting the rectum during a fecal incontinence episode.

21. The device 100 according to claim 1, wherein said fecal blocking element 14 comprising a small aperture 18 for the passage of gases.

22. The device 100 according to claim 1, wherein said fecal blocking element 14 further providing tactile feedback by palpation for accurate positioning and placement of said device by said individual over said anal opening.

23. The device 100 according to claim 1, further comprising a perineum absorbent patch or pad.

24. The device 100 according to claim 1, wherein said substrate is coupled to at least one electrode 11 configured for electrical stimulation of the S2-S3 dermatomes or surrounding perianal tissue or both; said at least one electrode 11 positioned unilaterally to said substrate.

25. The device 100 according to claim 24, wherein said rigid or semi-rigid support structure 19 providing maximum proximal interface between said at least one electrode 11 and skin surface of said individual; said maximum proximal interface providing increased transmission of electrical stimulation with lower resistance for a prolonged period of time.

26. The device 100 according to claim 24, wherein said at least one electrode 11 comprising at least two electrodes; said at least two electrodes positioned symmetrically about a midline of said substrate.

27. The device 100 according to claim 24, wherein said electrodes are screen printed electrodes (SPEs).

28. The device 100 according to claim 24, wherein said at least one electrode 11 is coupled to a control module; said control module comprising a microprocessor for controlling operational parameters of said electrical stimulation or electrical activity measurement.

29. The device 100 according to claim 1, wherein said rectal portion comprising a nonabsorbent hollow structure 22, and an absorbent three-dimensional fecal blocking element 24; said hollow structure 22 is formed from a silicone or another general-purpose synthetic elastomer; said buttocks support portion comprising a perforated hydrophobic carrier with skin adhesive 26, an absorbent three-dimensional lining 28 and occlusive protective lining30. The device 100 according to claim 1, wherein said rectal portion comprising an absorbent hollow structure 34, and an absorbent three-dimensional fecal blocking element 36; said buttocks support portion comprising a perforated hydrophobic carrier with skin adhesive 38, an absorbent lining 40 and occlusive cover 42.

31. The device 100 according to claim 1, wherein said rectal portion comprising a nonabsorbent structure 46; said non-absorbent structure 46 is formed from a silicone or another general-purpose synthetic elastomer; said buttocks support portion comprising a perforated hydrophobic carrier with skin adhesive 48, an absorbent lining 50 and occlusive cover 52.

32. The device 100 according to any one of claims 29 to 31, further comprising a conductive hydrogel; said conductive hydrogel comprising a three-dimensional structure to enable coupling with at least one electrode configured for electrical stimulation of a pudendal nerve or surrounding perianal tissue or both.

33. The device 100 according any one of claims 29 to 31, wherein said rectal portion comprising a therapeutic coating to facilitate a drug slow -release system; said drug slow -release system delivering a bioactive compound to an individual; said bioactive compound is a drug, pain reliever, antibiotic, anti-inflammatory, nanoparticle, or growth factor.

34. The device 100 according to any one of claims 29 to 31, wherein said rectal portion comprising an irrigation platform; said irrigation platform comprising fluid injection through said hollow structure formed from a silicone or another general-purpose synthetic elastomer; said fluid injection is directed into the lower bowel by way of the rectum; said fluid injection stimulating the emptying of the lower bowel of an individual.

35. The device 100 according to claim 1, wherein said rectal portion comprising accessible absorbent lining; said absorbent lining is removed after a fecal incontinence episode and replaced with new absorbent lining using an attachment / detachment aid; said attachment / detachment aid adapted to receive and detachably secure one finger or two fingers for application and removal of said absorbent lining from the intergluteal cleft of said individual.

36. The device 100 according to claim 35, wherein said attachment / detachment aid adapted to receive and detachably secure one finger 54 for accurate positioning, placement and removal of said device from the intergluteal cleft of said individual.

37. The device 100 according to claim 35, wherein said attachment / detachment aid adapted to receive and detachably secure two fingers 62 for accurate positioning, placement and removal of said device from the intergluteal cleft of said individual.

38. The device 100 according to claim 1, wherein said substrate comprising a plurality of Velcro bands attached to said substrate, whereby said Velcro and said substrate jointly serve to: a. link between the first side portion and second side portion of said buttocks support portion during usage of said device; and b. secure the folding of said rigid or semi-rigid support structure of said device during usage to: i. enhance the mechanical forces generated by the arch’s keystone blocking element; and ii. provide discrete and hygienic concealment of soiling in the used device prior to disposal of the removable component with said absorbent lining after a fecal incontinence episode of said individual.

39. The device 100 according to claim 1, wherein said buttocks support portion comprising a rigid or semi-rigid support structure, at least one adhesive layer, and a larger portion of flexible and stretchable material against a skin surface of said individual.

40. The device 100 according to claim 39, wherein said device is assembled in a way enhancing movement of said substrate against the skin during activity of said individual; said movement providing mechanical stimuli of the anus; said stimuli of the anus facilitating bowel movements.

41. The device 100 according to claim 1, wherein said substrate has a saddle shape and said rectal portion is curved for placement in an anus of said individual.

42. A device for treatment of pelvic floor disorders (PFDs) in an individual in need thereof, characterized by a multi-layer substrate with: a. a rectal portion, comprising a fecal blocking element; interconnected with b. a buttocks support portion, comprising flexible members with rigid ribs 19 and at least one adhesive layer 16 on the proximal side of said substrate configured to face a buttocks skin surface of said individual; and c. a perineum absorbent patch or pad.

43. A device for treatment of an overactive bladder (OAB) in an individual in need thereof, characterized by a multi-layer substrate with: a. a rectal portion, comprising a fecal blocking element; interconnected with b. a buttocks support portion, comprising flexible members with rigid ribs 19 and at least one adhesive layer 16 on the proximal side of said substrate configured to face a buttocks skin surface of said individual; and c. a perineum absorbent patch or pad.

44. A device for treatment of stress urinary incontinence (SUI) in an individual in need thereof, characterized by a multi-layer substrate with: a. a rectal portion, comprising a fecal blocking element; interconnected with b. a buttocks support portion, comprising flexible members with rigid ribs 19 and at least one adhesive layer 16 on the proximal side of said substrate configured to face a buttocks skin surface of said individual; and c. a perineum absorbent patch or pad.

45. A device for treatment of urge urinary incontinence (UUI) in an individual in need thereof, characterized by a multi-layer substrate with: a. a rectal portion, comprising a fecal blocking element; interconnected with b. a buttocks support portion, comprising flexible members with rigid ribs 19 and at least one adhesive layer 16 on the proximal side of said substrate configured to face a buttocks skin surface of said individual; and c. a perineum absorbent patch or pad.

46. The device according to any one of claims 42 to 45, wherein said multi-layer substrate has a cross-sectional shape that is substantially in the form of an "eight," such that said multi-layer substrate includes a central portion and two interconnected, opposing first and second loops, each loop being formed to conform to the anatomical contours of said individual’s intergluteal cleft, buttocks and perineum, providing a secure fit and enhanced sealing of the device during use.

47. A device for treatment of incontinence in an individual in need thereof, comprising a substrate characterized by a garment designed as underwear or panties; said garment comprising a fecal blocking element and a perineum absorbent patch or pad; said perineum absorbent patch or pad treating vaginal secretion and urinary incontinence.

48. The device 100 according to claim 28, wherein said electrodes are wireless electrodes; said wireless electrodes coupled to said control module via at least one of a Bluetooth connection, an infrared connection, and a wireless local area network connection.

49. The device 100 according to claim 28, wherein said control module 84 is external to said substrate 86 and coupled to at least one electrode with an electric cord or printed lead 88 or another general-purpose coupling mechanism.

50. The device 100 according to claim 49, wherein said electric cord or printed lead 90 is integrated into an elongated adhesive patch 92 of said substrate 94 and connected to said control module 96.

51. The device 100 according to claim 49, wherein said electric cord or printed lead 98 exits said substrate 101 through the posterior center buttocks of said individual and connects to said control module 102.

52. The device 100 according to claim 49, wherein said electric cord or printed lead 104 exits said substrate 106 through the anterior thigh of said individual and connects to said control module 108.

53. The device 100 according to claim 49, wherein said control module 114 is attached with a clip 116 on the clothing of said individual.

54. The device 100 according to claim 49, wherein said control module 124 is attached with a snap component and disposable adhesive patch 126 to the clothing of said individual.

55. The device 100 according to claim 49, wherein said control module 134 is attached to an integrated elastic belt 136 of said individual.

56. The device 100 according to claim 49, wherein said electric cord or printed lead 142 is connected to said control module 144 near said control module 144; said electric cord or printed lead 142 is part of said device 138.

57. The device 100 according to claim 49, wherein said electric cord or printed lead 150 is connected at some distance from said control module 152 to an extension cord 154 from said control module 152; said electric cord or printed lead 150 is part of said device; said extension cord 154 is part of said control module 152.

58. The device 100 according to claim 49, wherein said electric cord or printed lead 160 is part of said control module 162; said electric cord or printed lead 160 is connected to said device 156 near said device 156.

59. The device 100 according to claim 49, wherein said electric cord or printed lead 168 is connected at some distance from said control module 172 to an extension cord 170 from said control module 172; said electric cord or printed lead 168 is part of said device 164; said extension cord 170 is detachable from said control module 172.

60. The device 100 according to claim 49, wherein said control module 124 further comprising a button configured to activate on-demand, short duration electrical stimulation upon urge; said electrical stimulation activation can be combined with voluntary contraction of sphincter muscles; said combination of electrical stimulation and voluntary contraction of sphincter muscles can be sustained for a predetermined time period and repeated sequentially until said urge sensation is dismissed.

61. The device 100 according to claim 49, wherein said control module 124 is further configured to deliver continuous, sub-threshold electrical stimulation; said electrical stimulation acts as a transcutaneous neuromodulation of the sacral nerves through the S2-S3 dermatomes.

62. The device 100 according to claim 28, wherein said control module is attached to said substrate.

63. The device 100 according to claim 28, wherein said control module is coupled to at least one sensor in a control feedback loop.

64. The device 100 according to claim 28, wherein said at least one sensor obtaining measurements associated with muscle activity or neurological activity or both; said at least one sensor selected from the group consisting of an electromyography (EMG) sensor, an impedance sensor, a capacitance sensor, a wetness sensor, a pH sensor, a temperature sensor, and a position sensor.

65. The device 100 according to claim 64, wherein said measurements are reported to the patient or physician and used to: a. predict fecal incontinence frequency and patterns; b. adjust diet, prescription drugs and day-to-day behaviors; and c. regulate electrical stimulation properties or any other medical treatment.

66. The device 100 according to claim 64, wherein said measurements are used to predict defecation and to activate electrical stimulation autonomically.

67. The device 100 according to claim 64, wherein said measurements are used to determine the optimal electrical stimulation patterns to achieve continence using machine learning algorithms.

68. A method for treating fecal incontinence in an individual in need thereof, characterized by the steps of: a. affixing device 100 externally against a skin surface of an individual; said device comprising a multi-layer substrate with a rectal portion 10 and a buttocks support portion 12; said rectal portion 10 comprising a high-absorbency fill component or fecal blocking element 14; said buttocks support portion 12 comprising flexible portions with rigid or semi-rigid portions 19; said flexible portions comprising a center portion, a first side portion and a second side portion on an opposite side with at least one adhesive layer with removable liner on the proximal side of said substrate to be fixed against a skin surface of an individual; b. restricting feces from an episode of fecal incontinence with said high-absorbency fill component or blocking element preventing leakage of feces; c. retaining feces in said rectal portion with an impermeable cover layer until removal and disposal; d. disposing retained feces in said rectal portion with said removable absorbent lining; and e. optionally, replacing disposed absorbent lining with new absorbent lining in said device.

69. The method of claim 68, wherein said removable liner of said at least one adhesive layer used for packaging and easy placement and application of said device comprising steps of: a. removing said removable liner covering said adhesive layer of said center portion for positioning and placement of said rectal portion; and b. removing said removable liners covering said adhesive layers of said first side portion and said second side portion enabling full contact of said adhesive layers when affixing said device against the skin surface of an individual.

70. The method of claim 68, wherein said multi-layer substrate is coupled to at least one electrode 11 configured for electrical stimulation of the S2-S3 dermatomes or surrounding perianal tissue or both; said at least one electrode 11 positioned unilaterally to said substrate.

71. The method of claim 70, wherein immediate improvement in contraction of anal sphincter and pelvic floor muscles is achieved through the delivery of on-demand, acute electrical stimulation accompanied by voluntary contraction, resulting in dismissal of urge sensation and incontinence.

72. The method of claim 71, wherein said on demand, acute electrical stimulation is triggered by said individual upon an urge sensation or following a signal received from at least one sensor obtaining measurements associated with muscle activity or neurological activity or both, predicting oncoming urge; said at least one sensor selected from the group consisting of an electromyography (EMG) sensor, an impedance sensor, a capacitance sensor, a wetness sensor, a pH sensor, a temperature sensor, and a position sensor.

73. The method of claim 71, wherein improvement over time in contraction of anal sphincter and pelvic floor muscles is achieved through the repeated delivery of on-demand, acute stimulation accompanied by voluntary contraction, resulting in muscle reinforcement and strengthening74. The method of claim 71, wherein improvement in fecal incontinence conditions is achieved through the delivery of continuous, sub-threshold stimulation, to: a. provide neuromodulation of the sacral reflex pathways that control both the anal and bladder sphincters; b. improve muscle resting tone and overtime; and c. increase size and number of muscle fibers.

75. A method for treating fecal incontinence using a multimodal therapy, wherein at least one of the following members of a group is held true: a. providing a multi-layer substrate for: i. easy positioning adjacent to the anal region as a barrier and mechanical support; ii. easy application and removal; and iii. prolonged use to reduce urge sensation and fecal incontinence episodes;b. delivering short-duration stimulation (upon urge) for on-demand immediate dismissal of urge sensation, optionally combined with voluntary contraction to improve squeezing pressures and activate anal reflex, which can be used repeatedly over time to strengthen anal sphincter muscles and enhance voluntary control over defecation and urination; c. providing continuous background stimulation below sensory threshold for: i. neuromodulation of the sacral reflex pathways that control both the anal and bladder sphincters; ii. improvement of muscle resting tone; and iii. increase in size and number of muscle fibers over time; and d. providing personalized and customized approach to continence management using EMG and other biofeedback modalities.

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