WO2022261521A1 - Dispositifs et systèmes de collecte d'urine et procédés d'utilisation de tels dispositifs - Google Patents

Dispositifs et systèmes de collecte d'urine et procédés d'utilisation de tels dispositifs Download PDF

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Publication number
WO2022261521A1
WO2022261521A1 PCT/US2022/033155 US2022033155W WO2022261521A1 WO 2022261521 A1 WO2022261521 A1 WO 2022261521A1 US 2022033155 W US2022033155 W US 2022033155W WO 2022261521 A1 WO2022261521 A1 WO 2022261521A1
Authority
WO
WIPO (PCT)
Prior art keywords
tubing
pouch
interior
opening
vacuum
Prior art date
Application number
PCT/US2022/033155
Other languages
English (en)
Inventor
Maria Clarissa MANEZ
Original Assignee
The Board Of Trustees Of The Leland
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 The Board Of Trustees Of The Leland filed Critical The Board Of Trustees Of The Leland
Publication of WO2022261521A1 publication Critical patent/WO2022261521A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/451—Genital or anal receptacles
    • A61F5/453—Genital or anal receptacles for collecting urine or other discharge from male member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/443—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices having adhesive seals for securing to the body, e.g. of hydrocolloid type, e.g. gels, starches, karaya gums

Definitions

  • the present application is related to devices and methods for collecting bodily fluids and, more particularly, to devices and systems for urine collection for male patients, e.g., with retractile (buried) or uncircumcised penises, and to methods for using such devices and systems.
  • the present application is directed to devices and methods for collecting bodily fluids and, more particularly, to devices and systems for urine collection for male patients, e.g., with retractile (buried) or uncircumcised penises, and to methods for using such devices and systems.
  • a standalone kit may be provided, e.g., for use with bed-bound incontinent male patients with retractile (buried) or uncircumcised penis.
  • the kit may be used in a variety of patient care environments, including hospital intensive care units (ICUs), hospital medical surgical units, skilled nursing facilities (SNFs), long-term care facilities, assisted living facilities, rehab/sub -acute care facilities, and/or home health (e.g., home-based skilled nursing care for bed-bound patients equipped with home suctioning equipment).
  • ICUs hospital intensive care units
  • SNFs skilled nursing facilities
  • long-term care facilities e.g., assisted living facilities, rehab/sub -acute care facilities
  • home health e.g., home-based skilled nursing care for bed-bound patients equipped with home suctioning equipment.
  • the design of the kit may be optimized to accommodate patient self-care in the home for male individuals (elders and other individuals who meet desired criteria).
  • a device for collecting urine from a male subject that includes a pouch defining an interior and comprising an opening for placement adjacent a penis, e.g., around a retractile or buried penis, or sized for receiving at least a portion of a penis, and an outlet communicating with the interior; tubing coupled to the outlet such that a first end of the tubing communicates with the interior and a second end of the tubing is disposed outside the pouch; and porous and/or absorbent material within the interior adjacent the first end of the tubing for drawing fluid within the interior through the tubing towards the second end.
  • the porous material may include a sponge that at least partially fills the interior, e.g., disposed adjacent both the opening in the pouch and the first end of the tubing.
  • the sponge may be resiliently expandable, e.g., such that the sponge may collapse when suction is applied to the interior of the pouch, e.g., to facilitate drawing fluid into the tubing, and resiliently expand when suction is removed to expand the pouch and/or otherwise redistribute fluid within the pouch.
  • a system for collecting urine from a male subject that includes a collection device comprising a pouch defining an interior and comprising an opening for placement adjacent a penis, e.g., around a retractile or buried penis, or sized for receiving a penis and an outlet communicating with the interior; tubing coupled to the outlet such that a first end of the tubing communicates with the interior and a second end of the tubing is disposed outside the pouch; and porous and/or absorbent material within the interior adjacent the first end of the tubing for drawing fluid within the interior into and/or through the tubing towards the second end; and a source of vacuum connectable to the second end of the tubing.
  • a method for collecting urine from a male subject includes providing a pouch defining an interior and comprising an opening, and an outlet spaced apart from the opening and communicating with the interior, tubing coupled to the outlet such that a first end of the tubing communicates with the interior and a second end of the tubing is disposed outside the pouch, porous and/or absorbent material within the interior adjacent the first end of the tubing for drawing fluid within the interior into and/or through the tubing towards the second end; securing the opening around the penis of the subject; connecting the second end of the tubing to a source of vacuum; and applying the vacuum to the tubing to suction urine from the interior of the pouch.
  • FIG. 1 A shows an exemplary urine collection device.
  • FIG. IB is a detail of the pouch that may be provided in a urine collection device, such as that shown in FIG. 1 A.
  • FIG. 2 is a schematic showing how the device of FIG. 1 A would be placed on a male patient to provide a system for urine collection using suction.
  • FIGS. 1 A and IB show examples of a urine collection device 10 that includes a pouch or bag 20 defining an interior 21 and including an opening 22 sized to align with the urinary opening in patients with buried or retractile penis (or for receiving a at least a portion of subject’s penis) 92 (not shown, see, e.g., FIG. 2).
  • the pouch 20 may be provided in a collapsed condition and may be expandable to accommodate fluid being received within the interior 21.
  • the pouch 20 may be provided in a variety of sizes and/or shapes, as desired.
  • the pouch 20 may have a generally rectangular or other elongated shape, e.g., including one or more side panels 20a, 20b attached together around the perimeter of the pouch 20, e.g., to define first and second opposite ends 26a, 26b (which may be rounded or tapered, as shown in FIG. IB, or substantially straight, as shown in FIG. 1 A) and side edges 26c, 26d extending between the ends 26a, 26b.
  • the pouch 20 may be formed from two flat sheets of plastic or other material that are attached together around their perimeter, e.g., by one or more heat sealing, bonding with adhesive, sonic welding, fusing, and the like, to enclose the interior 21.
  • a single sheet may be formed that may be folded in half or otherwise over itself to provide both side panels 20a, 20b, which may then be attached together, e.g., at least partially around the perimeter or otherwise as needed to enclose the interior 21.
  • the pouch 20 may be formed from inelastic material that is flexible or semi rigid such that the pouch 20 may expand as fluid enters the interior 21 or, alternatively, the material may be elastic to accommodate expansion and/or contraction.
  • the pouch material may be transparent to allow observation of the interior 21 or may be opaque and/or include color to at least partially conceal the interior 21.
  • Adhesive may be provided on an exterior surface of the pouch 20 adjacent the opening 22 to secure the pouch 20.
  • a layer of adhesive 23 may be applied or otherwise attached directly to the exterior surface of the side panel 20b around the opening 22, e.g., covered with a removable sheet (not shown), which may be formed from biocompatible adhesive material having sufficient tackiness to secure the pouch 20 to the subject’s skin yet be removable without causing injury to the skin.
  • an adhesive patch 24 may be attached to the exterior surface of one of the side panels 20b that at least partially surrounds the opening 22. In the example shown in FIG.
  • the patch 24 may be constructed similar to a DuoDerm patch that is permanently attached to the pouch 20 and includes an opening or hole therethrough that is aligned with the opening 22 in the pouch 20, e.g., such that the patch 24 surrounds the opening 22.
  • the patch 24 may include an adhesive surface opposite the pouch 20, e.g., covered by a sheet (not shown) that may be removed before applying the adhesive surface to the subject’s skin, as described elsewhere herein.
  • the patch 24 may allow the pouch 20 to be removably secured to the subject’s groin 94, e.g., around the penis (or in alignment with the urinary opening of patients with retractile or buried penis) 92 to provide a seal that minimizes leakage of urine and direct urine into the interior 21 of the pouch 20, e.g., as shown in FIG. 2 and described further elsewhere herein.
  • groin 94 e.g., around the penis (or in alignment with the urinary opening of patients with retractile or buried penis) 92 to provide a seal that minimizes leakage of urine and direct urine into the interior 21 of the pouch 20, e.g., as shown in FIG. 2 and described further elsewhere herein.
  • one or more features may be provided around the opening 22 to accommodate increasing the size and/or modifying the shape of the opening 22, e.g., to accommodate the particular anatomy of an individual subject.
  • an elastic band, drawstring, or other element may be provided that at least partially surrounds the opening 22, which may be adjusted to expand or constrict the opening 22, e.g., to facilitate aligning the opening 22 with the urinary opening in a retractile or buried penis or receiving a portion of a penis.
  • an elastic band may be attached to the side panel 20b around the opening 22, which may be pulled open to expand the opening 22 but may be released such the elastic band resiliently contracts to constrict the opening 22, e.g., around a subject’s penis (not shown).
  • a drawstring or other filament may be mounted around the opening 22 with one or more ends that may be pulled to constrict the opening 22 and, optionally, tied or otherwise secured to maintain a desired size.
  • a user may cut or otherwise remove material around the opening 22, if desired, to increase the size and/or modify the shape of the opening 22, e.g., to conform with an individual subject’s anatomy.
  • the side panels 20a, 20b may be continuous, i.e., without any openings, and a user may simply cut one of the side panels of the pouch (and/or a continuous adhesive layer or patch attached to the side panel), at a desired location and/or with a desired diameter or other size to provide the opening 22.
  • the opening 22 is provided immediately adjacent the first end 26a of the pouch 20 and an outlet 28 may be provided at the second end 26b or otherwise spaced away from the opening 22.
  • a nipple or short tube 30 may be coupled to the pouch 20, e.g., inserted into and/or through the outlet 28, such that a first end 32 of the tube 30 is located within or otherwise communicates with the interior 21 of the pouch 20 and a second end 34 of the tube 30 is disposed outside the pouch 20.
  • the tube 30 may be inserted through a neck 29 in the pouch 20 defining the opening 28 and then permanently attached to the neck 29, e.g., by one or more of bonding with adhesive, sonic welding, fusing, and the like, such that the first end 32 of the tube 30 is disposed within the interior 21, e.g., adjacent the opening 22.
  • the first end 32 of the tube 30 may be attached directly to the wall of the pouch 20 around the opening 28 such that an inlet in the first end 32 communicates with the interior 21.
  • the second end 34 of the tube 30 may be connectable to a length of suction tubing 50.
  • the suction tubing 50 may include a first end 52 including a connector 56 for removably connecting the suction tubing 50 to the tube 30 and a second opposite end 54, which may also include a connector 58.
  • the connectors 56, 58 may be a male or female threaded connector, a twist-on connector, such as Luer lock fitting, a snap-on connector, and the like (not shown), e.g., that corresponds to a mating connector on the second end 34 of the tube 30 or on a device coupled to the second end 54 of the suction tubing 50.
  • the suction tubing 50 may be conventional non-conductive suction tubing having sufficient length to connect the device 10 to a source of vacuum, e.g., a syringe, pump, a vacuum line, and the like (not shown) that may be coupled to the connector 58 on the second end 54 of the tubing 50.
  • the suction tubing 50 may be permanently coupled to the short tube 30 or the short tube may be omitted and the first end 52 of the suction tubing permanently attached to the pouch 20, e.g., using the methods described above for the first end 32 of the short tubing 30.
  • the tube 30 exiting the pouch 20 may have sufficient length and, optionally, a connector, for coupling the second end 34 to a source of vacuum.
  • the source of vacuum may be a port of a vacuum line mounted to a wall or other structure of a hospital or other care facility (not shown).
  • the port and/or the connector 58 of the suction tubing 50 may include a valve (not shown), e.g., to allow a user to selectively open and close the vacuum line to intermittently apply suction to the tubing 50, 30 and, consequently, to the interior 21 of the pouch 20 to suction urine away from the subject.
  • a valve (not shown) may be provided on the tube 30, e.g., on the second end 34 of the tube 30.
  • Absorbent material 40 may be provided within the interior 21 of the pouch 20, e.g., adjacent the outlet 28 and/or the opening 22, e.g., for drawing fluid within the interior 21 of the pouch 20 through the tube 30 towards the second end 34 and/or redistributing fluid within the pouch 20.
  • the absorbent material 40 may be formed from synthetic or natural sponge or other porous material, e.g., open-celled foam material that allows fluid to flow freely within and/or through the sponge.
  • the absorbent material may be a piece of sponge 40 attached to the first end 32 of the tube 30 such that the sponge 40 is located adjacent the opening 22.
  • the absorbent material may be a separate sponge 40 disposed within the interior 21.
  • the sponge 40 may be sized such that a first end 42 of the sponge 40 may be disposed adjacent the opening 28 and/or first end 32 of the tube 30, e.g., contacting the wall of the second end 26b, and an opposite second end 44 is disposed adjacent the opening 22.
  • the second end 44 of the sponge 40 may be spaced away from the first end 26a of the pouch 20, e.g., such that the opening 22 is located between the sponge 40 and the first end 26a of the pouch 20 to provide an open region within the interior 21 for receiving the subject’s penis.
  • the sponge 40 may have a width smaller than the width of the pouch 20 such that the sponge 40 is spaced from the side walls 26c, 26d or the sponge 40 may substantially fill the interior 21 to contact the side walls 26c, 26d.
  • the sponge 40 may include substantially flat upper and lower surfaces, e.g., that contact the side walls 20a, 20b of the pouch 20 and/or may have a desired thickness, e.g., between about five and ten millimeters (5.0-10.0 mm) to space the side walls 26c, 26d apart when the sponge is in a relaxed state.
  • the sponge 40 may be fixed to one or more walls of the pouch 20, e.g., bonded to the inside surfaces of the side walls 20a, 20b, or may be freely moveable within the interior 21.
  • the sponge 40 may have sufficient size and/or porosity to at least partially fill the interior 21.
  • the sponge 40 may be sufficiently porous and/or flexible such that vacuum applied to the interior 21 may at least partially collapse the sponge 40, e.g., to direct urine within the pouch 20 through the outlet 28 and/or otherwise enhance removal of fluid from the interior 21.
  • the sponge 40 may be resiliently expandable, e.g., biased to a relaxed state such that the sponge 40 may collapse when suction is applied to the interior 21 of the pouch 20, e.g., to facilitate drawing fluid into the tube 30, and resiliently expand when suction is removed to expand the pouch 20 and/or otherwise redistribute fluid within the pouch 20, e.g., away from the subject’s penis or skin (in patients with buried or retractile penis).
  • the opening 22 may be secured around the penis 92 of a subject 90, e.g., using the patch 24, surrounding the opening 22 to seal the pouch 20 to the subject’s groin 94 around the penis 92.
  • the opening 22 may be secured around the penis to minimize exposure of the surrounding skin to urine.
  • the connector 58 of the suction tubing 50 (or directly to the second end 34 of the tube 30 if long enough) may be connected to a source of vacuum (not shown), and then vacuum may be applied to the tubing 50 to suction urine from the interior 21 of the pouch 20.
  • the connector 58 may be connected to a port and the vacuum line opened as desired, e.g., to intermittently suction urine from the pouch 20 through the tube 30 and tubing 50.
  • a care provider can simply open and close a valve (not shown) of the vacuum line (or provided on the tube 50 or 30) to suction urine from the pouch 20 away from the subject’s skin, which may increase the subject’s comfort and/or minimize skin injury from urine that may otherwise, leak and/or contact the subject’s skin.
  • the vacuum When suction is applied, the vacuum may collapse the sponge 40 within the interior 21, thereby facilitating evacuating urine within the pouch.
  • the sponge 40 When the suction is discontinued, the sponge 40 may resiliently expand to its relaxed shape, which may be expand the interior 21 of the pouch 20 and/or redistribute urine within the pouch 20, e.g., away from the subject’s skin.
  • the pouch 20 may be removed from the subject and replaced with a new device 10, and the old pouch 20 discarded.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Reproductive Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

L'invention concerne un dispositif de collecte d'urine qui comprend une poche délimitant un espace intérieur et comprenant une ouverture dimensionnée pour être placée autour d'un élément rétractable ou enfoncée, et un orifice de sortie communiquant avec l'intérieur. Une première extrémité de tube communique avec l'orifice de sortie et une seconde extrémité de tube est disposée à l'extérieur de la poche. Un matériau poreux et/ou absorbant est disposé dans l'espace intérieur pour aspirer un fluide se trouvant dans l'espace intérieur à travers le tube et vers la seconde extrémité. La seconde extrémité du tube peut être raccordée à une source de vide pour permettre une aspiration intermittente de l'urine hors de l'espace intérieur de la poche. Le matériau absorbant peut être dilatable élastiquement, par exemple, de telle sorte que le matériau peut s'affaisser lorsqu'une aspiration est appliquée à l'intérieur de la poche, par exemple, pour faciliter l'aspiration de fluide dans le tube, et peut se dilater de manière élastique lorsque l'aspiration est interrompue.
PCT/US2022/033155 2021-06-12 2022-06-11 Dispositifs et systèmes de collecte d'urine et procédés d'utilisation de tels dispositifs WO2022261521A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163209999P 2021-06-12 2021-06-12
US63/209,999 2021-06-12

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WO2022261521A1 true WO2022261521A1 (fr) 2022-12-15

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110040272A1 (en) * 2006-09-30 2011-02-17 Funnelly Enough Limited Urine collection device
KR20130007535A (ko) * 2009-11-27 2013-01-18 가부시키가이샤 리브도 코포레이션 소변 흡수 물품
US20190247222A1 (en) * 2018-02-14 2019-08-15 Sage Products, Llc Devices and Systems for Urine Collection
US20190282391A1 (en) * 2017-01-31 2019-09-19 Purewick Corporation Apparatus and methods for receiving discharged urine
WO2021086868A1 (fr) * 2019-10-28 2021-05-06 Purewick Corporation Ensembles de collecte de fluide comprenant un orifice d'échantillon

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110040272A1 (en) * 2006-09-30 2011-02-17 Funnelly Enough Limited Urine collection device
KR20130007535A (ko) * 2009-11-27 2013-01-18 가부시키가이샤 리브도 코포레이션 소변 흡수 물품
US20190282391A1 (en) * 2017-01-31 2019-09-19 Purewick Corporation Apparatus and methods for receiving discharged urine
US20190247222A1 (en) * 2018-02-14 2019-08-15 Sage Products, Llc Devices and Systems for Urine Collection
WO2021086868A1 (fr) * 2019-10-28 2021-05-06 Purewick Corporation Ensembles de collecte de fluide comprenant un orifice d'échantillon

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