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WO2025129142A1 - Système et méthode de surveillance de mouvements périnéaux associés au plancher pelvien - Google Patents

Système et méthode de surveillance de mouvements périnéaux associés au plancher pelvien Download PDF

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Publication number
WO2025129142A1
WO2025129142A1 PCT/US2024/060238 US2024060238W WO2025129142A1 WO 2025129142 A1 WO2025129142 A1 WO 2025129142A1 US 2024060238 W US2024060238 W US 2024060238W WO 2025129142 A1 WO2025129142 A1 WO 2025129142A1
Authority
WO
WIPO (PCT)
Prior art keywords
perineal
movement detection
detection device
subject
pelvic floor
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/060238
Other languages
English (en)
Inventor
Jordynn LURIE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kero LLC
Original Assignee
Kero LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kero LLC filed Critical Kero LLC
Publication of WO2025129142A1 publication Critical patent/WO2025129142A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/1113—Local tracking of patients, e.g. in a hospital or private home
    • A61B5/1114—Tracking parts of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/1107—Measuring contraction of parts of the body, e.g. organ or muscle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/6804—Garments; Clothes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6823—Trunk, e.g., chest, back, abdomen, hip
    • A—HUMAN NECESSITIES
    • A63—SPORTS; GAMES; AMUSEMENTS
    • A63B—APPARATUS FOR PHYSICAL TRAINING, GYMNASTICS, SWIMMING, CLIMBING, OR FENCING; BALL GAMES; TRAINING EQUIPMENT
    • A63B23/00—Exercising apparatus specially adapted for particular parts of the body
    • A63B23/20—Exercising apparatus specially adapted for particular parts of the body for vaginal muscles or other sphincter-type muscles

Definitions

  • Pelvic floor dysfunction decreases quality of life and can lead to medical complications of increasing severity. For example, involuntary leakage of urine due to weakness of pelvic floor muscles (urinary incontinence) is such a complication that affects both men and women. Urinary incontinence (UI) is prevalent for women in the U.S. wherein approximately 23 million women ages 50-80 and approximately 1.2 million new mothers suffer with this condition.
  • UI Urinary incontinence
  • the invention provides this needed new approach.
  • the orientation of the perineum changes by lifting in the cranial/ventral direction, and during the release or strain of the pelvic floor, the orientation of the perineum changes by dropping in the caudal/dorsal direction.
  • the herein described system and method involve monitoring this change in orientation of the perineum and include recognizing pelvic floor contraction and release/strain of a subject throughout sessions of voluntary pelvic floor contractions (Kegel exercises or “Kegels’”), in which a perineal movement detecting device is externally situated against the subject’s perineum.
  • the systems and methods described provide a new paradigm for monitoring performance of Kegel exercises to improve their effectiveness at strengthening muscles of the pelvic floor.
  • the invention provides an engaging new way of performing Kegel exercises. In a general aspect, the invention provides a more effective way of performing Kegel exercises. In another general aspect, the invention provides devices and methods for external monitoring of pelvic floor movement.
  • the invention provides a system for externally monitoring orientation of a perineum of a subject during a contract! on/rel ease of pelvic floor muscles of the subject.
  • a subject is able to determine whether they are performing Kegel exercises correctly and thus, the subject is able to adjust their technique if necessary. In this way, a subject has a more beneficial exercise session.
  • a subject refers to any human or animal that can benefit from the systems and methods disclosed herein.
  • a “subject” may also be referred to as a “patient.”
  • the system includes, but is not limited thereto, a perineal movement detection device configured for external arrangement flush against the perineum of the subject; a computer device configured for communication with the perineal movement detection device; and a placement pad configured for enclosing the perineal movement detection device and fixing the perineal movement detection device to a location on an undergarment of the subject such that orientation of the perineal movement detection device relative to a sagittal axis of the perineum of the subject is maintained during use of the system.
  • the computer device can communicate with the perineal movement detection device wirelessly or via a wired communication interface.
  • the perineal movement detection device includes a set of elements, including but not limited thereto, a perineal accelerometer, a processor, a transceiver, and a control accelerometer. These elements can be included individually or in any combination.
  • the computer device includes a set of elements, including but not limited thereto, a transceiver, a memory, a processor, and a user display. These elements can be included individually or in any combination.
  • the elements of the perineal movement detection device can be enclosed or encased within a housing.
  • the housing can be divided into regions including, but not limited thereto, an electronics region at a first end; a perineal sensing region at an end opposite the first end; and a connection strip configured as a spacer and a connection between the electronics region and the perineal sensing region.
  • the perineal sensing region has a smaller width than a width of the electronics region.
  • the placement pad can be divided into regions corresponding to the regions of the housing; for example, but not limited thereto, an anterior region corresponding to the electronics region of the housing; a posterior region corresponding to the perineal sensing region of the housing; and a connection strip corresponding to the connection strip of the housing.
  • a placement pad is used in exemplary embodiments, the disclosure envisions the use of any suitable device for fixing the perineal movement detection device relative to a sagittal axis of the perineum of the subject.
  • the placement pad is constructed of connected layers having an opening at one end.
  • An embodiment of the layers includes an adhesive layer and a sanitary' layer.
  • the adhesive layer attaches the perineal movement detection device to the undergarment of the subject.
  • a non-limiting example of a placement pad includes an adhesive layer on one surface configured for fixing the perineal movement detection device to the location on the undergarment of the subject, a sanitary layer having a same shape as the adhesive layer and connected to the adhesive layer along a perimeter of the adhesive layer to form an interior space configured to enclose the perineal movement detection device between the adhesive layer and the sanitary layer, and an opening to the interior space at the anterior region configured for insertion of the perineal movement detection device.
  • the perineal movement detection device includes a perineal accelerometer arranged in the perineal sensing region of the housing.
  • the perineal accelerometer is configured for externally monitoring orientation of the perineal sensing region.
  • the perineal movement detection device includes a control accelerometer arranged in the electronics region of the housing.
  • the control accelerometer is configured for sensing non-perineal movements of the subject and for removing signals due to the non-perineal movements from the perineal accelerometer.
  • the control accelerometer functions to ensure that the perineal movement detection device measures only true movements of the perineum of the subject.
  • the perineal movement detection device includes a processor and a transceiver arranged in the electronics region of the housing.
  • the transceiver is configured to receive data from the computer device and to transmit data to the computer device.
  • the computer device includes a transceiver, a processor, and a user display.
  • the transceiver is configured to transmit data to and receive data from the perineal movement detection device and the user display is configured to convey output data from the processor to the subject using the system.
  • the computer device includes a memory and system configuration programs.
  • the memory includes data storage, such as but not limited to, a data bucket.
  • the computer device includes a gaming app; for example, but not limited to, a gaming app based on non-invasive Kegel biofeedback.
  • the gaming app allows the subject to make Kegel exercise a game and thus less monotonous. Subjects are more likely to exercise consistently if exercise is a fun and engaging game.
  • the elements used in the inventive system can be packaged in containers and assembled in kits together with instructions for use.
  • Non-limiting examples of these elements are a perineal movement detection device, a plurality of placement pads, and a computer device.
  • Kit elements are physically associated in or with one or more containers and considered as a unit for manufacture, distribution, sale, or use. All or some of the elements of the inventive system can be packaged as kits.
  • the invention provides a method for externally monitoring orientation of a perineum of a subject during contraction/release of pelvic floor muscles using the inventive system described herein and employing the system concurrently with their exercise routine.
  • the invention provides a method for externally monitoring orientation of a perineum of a subject during a contraction/release of pelvic floor muscles including inserting a perineal movement detection device into a placement pad such that the perineal movement detection is enclosed in an interior of the placement pad; attaching the placement pad to an undergarment such that a posterior region of the placement pad corresponds to a perineal sensing region of the perineal movement detection device; initiating a series of voluntary pelvic floor contractions beginning a measurement period; monitoring the orientation of the perineum during the series of voluntary pelvic floor contractions; and processing orientation data thereby generating an output signal indicating if there has been a contraction or release of the pelvic floor muscles during the measurement period.
  • the method can also include adjusting exercise technique if the output signal indicates that Kegels are being performed incorrectly.
  • the inventive method can be used for detecting Kegel exercises externally, re-gaining urinary' continence, strengthening muscles of the pelvic floor, regaining control of the muscles of the pelvic floor, and/or treating urinary' incontinence and other pelvic floor dysfunctions.
  • FIG. 1 is an illustration of the anatomy of the human female pelvic floor showing normal pelvic floor muscles and positioning of internal organs.
  • FIG. 2 is an illustration of the anatomy of the human female pelvic floor show ing loose/weakened/dysfunctional pelvic floor muscles and out-of-place internal organs.
  • FIG. 3 is an illustration of the application of the perineal movement detection device in an undergarment.
  • the device is inserted into a placement pad and the placement pad is attached to the undergarment.
  • the star indicates the location of the perineal accelerometer.
  • FIG. 4 is an illustration of the anatomy of the human female pelvic floor show ing orientation of the deep muscle layer and the superficial muscle layer.
  • the star indicates the location of the perineum.
  • the perineal accelerometer is externally arranged against the perineum.
  • the arrow shows direction of movement during contraction of the pelvic floor.
  • FIG. 5 is a graph illustrating an output signal as detected by the perineal movement detection device. The graph shows an output signal for one full Kegel.
  • the processor 132 is configured to monitor pelvic floor muscle activity of a subject/user who is using the perineal movement detection device 110, and to recognize pelvic floor contraction and release/strain of the subject/user throughout sessions of voluntary pelvic floor contractions.
  • the processor 132 implements the functionality necessary to processes/act on/maintain items of received or generated data.
  • the computer device 130 can process orientation data generated by the perineal accelerometer 114 and control accelerometer 113 to generate an output that indicates if there has been a contraction or release/strain of the pelvic floor muscles during a measurement period.
  • the calibrated orientation data and generated outputs from the processor can be displayed to the subject/user via the output device unit 134.
  • An example of output signal data is shown in FIG. 5. Specifically, the bracket 30 shows the signal for one full Kegel discernable from background.
  • a data bucket 131a stores orientation data received from the perineal movement detection device 110 and data generated by actions performed by the computer device 130.
  • An orientation determination module 131c is also provided that is configured to process the orientation data to determine a direction of rotation of the perineal movement detection device 110 during a measurement period and to generate an output indicating that there has been either a contraction or release of the pelvic floor muscles.
  • the orientation data provided by the perineal accelerometer 114 and control accelerometer 113 will typically comprise a time series sequence of data points, with each data point defining the measured orientation of the perineal movement detection device at a particular point in time.
  • the orientation/rotation determination module 131c could then be configured to determine a direction of rotation of the perineal movement detection device 110 when the change in the orientation of the perineal movement detection device during the measurement penod continues in the same direction for a predefined number of contiguous data points.
  • a calibration module 131 Z> can be implemented to generate parameters for calibrating the processing implemented by the system 100.
  • the perineal movement detection device 110 would be fixed in the proper location relative to the subject/user while the subject/user is instructed to remain still, and an anatomical calibration phase initiated.
  • the calibration module 1316 w ould process data generated by the perineal accelerometer 114 and control accelerometer 113 to calculate values that are indicative of noise present within the subject/user at rest. These values can then be used by the orientation determination module 131c to eliminate noise due to the subject’s/user’s anatomy at rest from the orientation data generated during the measurement period.
  • the orientation determination module 131c could be configured to apply upper and lower thresholds to the accelerometer data generated during the measurement period.
  • a calibration can also be performed on the system 100 to account for noise that is present within the perineal movement detection device 110 itself. For this, before the perineal movement detection device 110 is positioned for use by the subject/user, the device would be held stationary, and an external calibration phase initiated. Upon initiation of the external calibration phase, the calibration module 131b would process data generated by the accelerometer 114 and control accelerometer 113 to calculate values that are indicative of noise present within the device. These values can then be used by the calibration module 131/? when performing the anatomical calibration of the subject/user.
  • An initiation detection module 13 k/ can also be provided that is configured to detect the initiation of pelvic floor muscle movement and commence a measurement period.
  • This module can be configured to detect the initiation of a pelvic floor muscle movement upon receiving a subject/user input indicating the initiation of a pelvic floor muscle movement.
  • the initiation detection module 131rf can be configured to detect the initiation of a pelvic floor muscle movement by utilizing the orientation or acceleration data of the perineal accelerometer (on its own or in comparison to that of the control accelerometer 113 to detect significant movement of the perineal movement detection device 110 as an indication of pelvic floor muscle movement initiation.
  • Kegel Exercises A How-to Guide for Women; accessed from the website of the Mayo Clinic on August 18, 2023. Kegel exercises: A how-to guide for women - Mavo Clinic

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Dentistry (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Physiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne un système et une méthode de surveillance des mouvements périnéaux associés au plancher pelvien afin de suivre et/ou de ludifier l'exercice des muscles pelviens dans le but d'améliorer la fonction musculaire pelvienne dans le traitement de l'incontinence urinaire (UI) et d'autres dysfonctionnements du plancher pelvien. Un dispositif de détection de mouvement périnéal non invasif est conçu pour un agencement externe affleurant le périnée du sujet. Un dispositif informatique est configuré pour une communication avec le dispositif de détection de mouvement périnéal. Un élément de placement fixe le dispositif de détection de mouvement périnéal dans une position anatomiquement pertinente par rapport à l'utilisateur pendant l'utilisation du système.
PCT/US2024/060238 2023-12-14 2024-12-13 Système et méthode de surveillance de mouvements périnéaux associés au plancher pelvien Pending WO2025129142A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363610112P 2023-12-14 2023-12-14
US63/610,112 2023-12-14

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WO2025129142A1 true WO2025129142A1 (fr) 2025-06-19

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014176420A1 (fr) * 2013-04-24 2014-10-30 Tufts University Appareil, systèmes et procédés pour détecter ou stimuler une activité musculaire
US20150290450A1 (en) * 2014-04-14 2015-10-15 Elidah, LLC Device to Treat Incontinence
US20160199696A1 (en) * 2012-12-19 2016-07-14 Alert Core, Inc. System, apparatus, and method for promoting usage of core muscles and other applications
US9591983B2 (en) * 2013-06-01 2017-03-14 Healthwatch Ltd. Wearable fetal monitoring system having textile electrodes
US20170095207A1 (en) * 2015-10-05 2017-04-06 Minna Life, Inc. Pressure-Sensing Devices
US20170319103A1 (en) * 2014-10-28 2017-11-09 Chiaro Technology Limited Method and apparatus for monitoring the pelvic floor muscles
US20190246937A1 (en) * 2016-09-28 2019-08-15 Children`S Medical Center Corporation Pelvic Muscle Rehabilitation for Treating Urinary Incontinence

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160199696A1 (en) * 2012-12-19 2016-07-14 Alert Core, Inc. System, apparatus, and method for promoting usage of core muscles and other applications
WO2014176420A1 (fr) * 2013-04-24 2014-10-30 Tufts University Appareil, systèmes et procédés pour détecter ou stimuler une activité musculaire
US9591983B2 (en) * 2013-06-01 2017-03-14 Healthwatch Ltd. Wearable fetal monitoring system having textile electrodes
US20150290450A1 (en) * 2014-04-14 2015-10-15 Elidah, LLC Device to Treat Incontinence
US20170319103A1 (en) * 2014-10-28 2017-11-09 Chiaro Technology Limited Method and apparatus for monitoring the pelvic floor muscles
US20170095207A1 (en) * 2015-10-05 2017-04-06 Minna Life, Inc. Pressure-Sensing Devices
US20190246937A1 (en) * 2016-09-28 2019-08-15 Children`S Medical Center Corporation Pelvic Muscle Rehabilitation for Treating Urinary Incontinence

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