US-12616562-B2 - Systems and methods for continence training

US12616562B2US 12616562 B2US12616562 B2US 12616562B2US-12616562-B2

Abstract

A medical device for reducing incontinence can be dimensioned to be placed in an interior region of a subject surrounded by muscle tissue. The medical device can include a first balloon having an interior space containing a fluid. The proximal end of a first fluid conduit can be coupled to an outlet of the first balloon. The medical device can also include a pressure sensing detector coupled to a distal end of the first fluid conduit. The pressure sensing detector can include a second balloon. The second balloon can also be in fluid communication with the interior space of the first balloon. The first balloon can be compressed from the contraction of the muscle tissue, which can displace a portion of the fluid within the interior space of the first balloon. The portion of fluid moves towards the second balloon and causes the second balloon to increase in interior volume thereby indicating a contraction force of the muscle tissue.

Inventors

Reza Shaker
Anisa Shaker

Assignees

THE MEDICAL COLLEGE OF WISCONSIN, INC.
UNIVERSITY OF SOUTHERN CALIFORNIA

Dates

Publication Date: 20260505
Application Date: 20200123

Claims (8)

1 . A medical device for reducing incontinence, the medical device comprising: a first balloon having a first end and a second end, the first balloon defining an interior surface and an exterior surface, the interior surface defining an interior space, the interior space including a fluid, the first balloon having an outlet disposed on the first end of the balloon, the outlet being in fluid communication with the interior space of the first balloon, wherein the first balloon is dimensioned and configured to be placed in an interior region of a subject's body surrounded by muscle tissue; a first fluid conduit having a proximal end and a distal end, the proximal end being coupled to the outlet of the first balloon, the fluid conduit being in fluid communication with the outlet and the interior space of the first balloon; and a pressure sensing detector coupled to the distal end of the first fluid conduit, the pressure sensing detector including a second balloon, the second balloon being in fluid communication with the interior space of the first balloon, the second balloon having an exterior surface with a plurality of markings thereon, wherein the second balloon is configured to be positioned outside of the subject's body, and wherein compression of the first balloon by contraction of the muscle tissue displaces a portion of the fluid within the interior space of the first balloon, the portion of the fluid moving towards and into the second balloon and causing an increase in interior volume of the second balloon and expansion of the exterior surface of the second balloon, thereby indicating, via the plurality of markings, a contraction force of the muscle tissue and a magnitude of the compression of the first balloon.
2 . The medical device of claim 1 , wherein the interior region includes a transsphincteric region.
3 . The medical device of claim 1 , wherein the interior region includes a vaginal cavity.
4 . The medical device of claim 1 , further comprising: a second fluid conduit in fluid communication with the interior space of the first balloon, wherein the second fluid conduit defines a fluid path; and a valve, connectable to a fluid source for supplying the fluid, positioned in the fluid path, wherein the valve allows the fluid to flow into the interior space of the first balloon thereby expanding the first balloon.
5 . The medical device of claim 4 , wherein the valve allows the fluid within the interior space of the first balloon to flow out of the interior space of the first balloon and be released into the atmosphere.
6 . The medical device of claim 5 , wherein the fluid within the interior space of the first balloon defines a maximum amount of fluid, such that the first balloon prevents additional fluid from entering the interior space.
7 . The medical device of claim 6 , wherein the maximum amount of fluid within the interior space of the first balloon defines a first loading pressure.
8 . The medical device of claim 7 , wherein the first loading pressure compresses the muscle tissue.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application represents the national stage entry of PCT/US2020/014820 filed on Jan. 23, 2020 and claims priority to U.S. Patent Application No. 62/795,719 filed Jan. 23, 2019, which is hereby incorporated by reference herein in its entirety for all purposes. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH Not applicable. BACKGROUND Fecal incontinence is an overarching term or symptom defined by the decrease in ability to control (or contain) bowel movements. In some cases, the decreased control can cause feces to uncontrollably leak from the individual's rectum, which can cause significant social anxiety and decreased quality of life. Fecal incontinence tends to be especially prevalent among older individuals (the older adult population), however, the condition may be difficult to treat, as patients generally do not present incontinence symptoms to physicians (e.g., due to embarrassment over the symptoms). Correspondingly, physicians often fail to ask directly about incontinence symptoms, because of the stigma associated with this condition. Fecal incontinence not only affects individuals across the globe, but also a significant portion of people within the U.S. For example, a national survey of 7200 individuals showed one in seven individuals reporting any history of fecal incontinence and one in three reporting fecal incontinence within the preceding week. See, Stacy B. Meness et al., “Prevalence of and Factors Associated With Fecal Incontinence: Results From a Population-Based Survey”, Gastroenterology, vol. 154, issue 6, pages 1672-1681, May 2018. The incidence of fecal incontinence also increases with an increasing age of the population. For example, the highest prevalence of fecal incontinence is in individuals over age 65. Additionally, according to another survey of around 70,000 individuals, 14.4% of the respondents (10,033 individuals) reported a history of fecal incontinence, and 33.3% of the respondents (˜23,224 individuals) had experienced at least one episode of fecal incontinence in the week prior to the survey. Additionally, the third of individuals with fecal incontinence experienced a week prior to the survey, said it interfered with their daily activities. Id. “Increasing age and concomitant diarrhea and constipation were associated with increased odds [of] fecal incontinence”. Id. As indicated above, fecal incontinence generally increases with an individual's age. For example, compared to individuals aged 18-24 years, the odds of having ever experienced fecal incontinence rose by 29% among those aged 25-45 years, rose by 72% among those aged 45-64 years, and rose by 118% among persons aged 65 years and older. Id. Current therapy for fecal incontinence is very limited. Surgical approaches exist but have not been successful. Thus, it would be desirable to have improved systems and methods for reducing fecal incontinence. SUMMARY OF THE INVENTION Some embodiments of the disclosure provide a medical device for reducing incontinence. The medical device can be dimensioned in order to be placed in an interior region of a subject surrounded by muscle tissue. The medical device can include a first balloon having a first end, a second end, an interior surface, and an exterior surface. The interior surface can define an interior space, where the interior space includes a fluid. The first balloon can have an outlet disposed on the first end of the balloon, where the outlet can be in fluid communication with the interior space of the first balloon. The medical device can also include a first fluid conduit having a proximal end and a distal end. The proximal end can be coupled to the outlet of the first balloon, where the fluid conduit can be in fluid communication with the outlet and the interior space of the first balloon. The medical device can also include a pressure sensing detector coupled to the distal end of the first fluid conduit. The pressure sensing detector can include a second balloon. The second balloon can also be in fluid communication with the interior space of the first balloon. The first balloon can be compressed from the contraction of the muscle tissue, which can displace a portion of the fluid within the interior space of the first balloon. The portion of fluid moves towards the second balloon and causes the second balloon to increase in interior volume thereby indicating a contraction force of the muscle tissue. In some embodiments, the interior region includes a transsphincteric region. In some embodiments, the interior region includes a vaginal cavity. In some embodiments, the medical device further comprises: a second fluid conduit in fluid communication with the interior space of the first balloon and a source of fluid, wherein the second fluid conduit defines a fluid path, and wherein the source of fluid supplies the fluid; and a valve positioned in the fluid path, wherein the valve allows the fluid from the fluid source to flow