WO2026035497A1 - Dispositifs, systèmes et procédés de gestion d'urine - Google Patents

Dispositifs, systèmes et procédés de gestion d'urine

Info

Publication number
WO2026035497A1
WO2026035497A1 PCT/US2025/039906 US2025039906W WO2026035497A1 WO 2026035497 A1 WO2026035497 A1 WO 2026035497A1 US 2025039906 W US2025039906 W US 2025039906W WO 2026035497 A1 WO2026035497 A1 WO 2026035497A1
Authority
WO
WIPO (PCT)
Prior art keywords
base
management device
collection chamber
urine
user
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/US2025/039906
Other languages
English (en)
Inventor
Rose ANCONETANI
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.)
Sage Products LLC
Original Assignee
Sage Products 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 Sage Products LLC filed Critical Sage Products LLC
Publication of WO2026035497A1 publication Critical patent/WO2026035497A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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; 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; Colostomy devices
    • A61F5/4404—Details or parts
    • 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; Colostomy devices
    • A61F5/443—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices having adhesive seals for securing to the body, e.g. of hydrocolloid type seals, e.g. gels, starches, karaya gums

Definitions

  • the present disclosure generally relates to devices, systems, and methods for managing urine discharged from the body of a user and carrying the urine away from the body.
  • a user may have limited or impaired mobility such that ordinary urinary functions and processes are rendered difficult or impossible.
  • a person may have impaired mobility due to a disability or may be bedridden due to an injury or illness.
  • a person may be subject to restricted occupational conditions under which the person has limited mobility.
  • urine collection may be needed for monitoring purposes, such as tracking inputs and outputs in a clinical setting (e.g., in an intensive care unit or for other clinical and/or laboratory testing).
  • a urine management device includes a base that is configured to couple to a body of a user.
  • the base includes a proximal side and a distal side.
  • the proximal side of the base includes a first adhesive that is configured to adhere the base to the body of the user.
  • the base includes an aperture that extends through the proximal side and the distal side, and is configured to extend around an anatomy of the user when the anatomy of the user is positioned in the aperture of the base.
  • the urine management device also includes a collection chamber having a rim and a liquid-impermeable wall extending distally from the rim.
  • An inner surface of the liquid-impermeable wall has a concave shape such that the liquid-impermeable wall defines an internal cavity that is recessed from the rim.
  • the rim defines an opening that provides access to the internal cavity.
  • the management device also includes a second adhesive that is configured to couple the rim of the collection chamber to the distal side of the base.
  • the management device also includes a diverter coupled to the base at a lower portion of the aperture of the base. The diverter is configured to guide urine discharged from the anatomy of the user into the internal cavity of the collection chamber. Additionally, the urine management device includes an outlet for egressing urine from the internal cavity of the collection chamber.
  • Figure 1 illustrates simplified diagram of a device for managing urine, according to an example of the present disclosure.
  • Figure 2 illustrates a perspective view of a urine management device in an open position, according to an example of the present disclosure.
  • Figure 3 illustrates a perspective view of a urine management device in a closed position, according to an example of the present disclosure.
  • Figure 4 illustrates a distal side of a base of a urine management device that is in an open position, according to an example of the present disclosure.
  • Figure 5 illustrates a diverter of a urine management device that is in an open position, according to an example of the present disclosure.
  • Figure 6 illustrates a proximal side of a base of a urine management device, according to an example of the present disclosure.
  • Figure 7 illustrates a gasket ridge along a perimeter of a proximal end of a collection chamber of a urine management device, according to an example of the present disclosure.
  • Figure 8 illustrates simplified diagram of a system for collecting urine, according to an example.
  • Figure 9 illustrates a flowchart for a process for collecting urine, according to an example.
  • a condom catheter In general, a condom catheter is provided with an adhesive on an interior of the catheter. When the condom catheter is unrolled onto a user’s penis, the adhesive is between the penis and the inner surface of the condom. In this way, the adhesive can adhere the condom directly to the penis. This approach can be uncomfortable for the user given that the adhesive is in contact with a relatively sensitive area of the body.
  • a condom catheter may require a relatively snug fit with the penis. If the condom catheter is too tight, the user may experience discomfort. If the condom is too loose, it may not remain properly positioned on the penis of the user. This problem can be exacerbated by the fact that different users have differently sized penises. As such, it can be difficult to determine which size is appropriate for a given user. Moreover, the processes of attaching the condom catheter to the user and removing the condom catheter can be complicated and difficult for users and medical caregivers.
  • the devices and systems of the present disclosure provide for urine management devices that can address at least some of the drawbacks of existing male external catheters and urine collection devices.
  • FIG. 1 illustrates a simplified block diagram of a urine management device 100 according to an example.
  • the urine management device 100 includes a collection chamber 130 hingedly coupled to a base 110.
  • the base 110 includes a proximal side and a distal side.
  • the proximal side of the base 110 is configured to contact a pelvic area of a user and the distal side faces the collection chamber 130.
  • the collection chamber 130 can be folded out of the way, allowing a clinician full access to adhere the base 110 to the pelvic area. Once the base 110 is securely adhered to the user's body, the collection chamber 130 can be folded back and coupled to the base 110, creating a secure seal.
  • the proximal side of the base 110 includes a first adhesive 180 that is configured to adhere the base 110 to the body of the user.
  • first adhesive 180 can contact and adhere to a pelvic area of the user to assist in retaining the urine management device 100 in the desired position.
  • the first adhesive 180 can more comfortably adhere the base 110 of the urine management device 100 to a less sensitive part of the body than a condom catheter.
  • the base 110 includes an aperture 113 that extends through the proximal side and the distal side. Additionally, the base 110 is configured to extend around the penis of the user when the penis of the user is positioned in the aperture 113 of the base 110 (further described below with reference to Figure 6).
  • the size of the aperture 113 can be configured according to the size and location of the penis. This can help provide a proper fit, accommodating various anatomies and providing an effective seal to prevent leaks.
  • the urine management device 100 includes a collection chamber 130 that is coupled to the base 110 at a proximal end of the collection chamber 130.
  • the collection chamber 130 includes a rim 133 and a liquid-impermeable wall 134 extending distally from the rim 133.
  • An inner surface of the liquid-impermeable wall 134 has a concave shape such that the liquid-impermeable wall 134 defines an internal cavity 135 that is recessed from the rim 133.
  • the rim 133 defines an opening 136 that provides access to the internal cavity 135.
  • the collection chamber 130 also includes a second adhesive 182 that is configured to couple the rim 133 of the collection chamber 130 to the distal side of the base 110.
  • the collection chamber 130 can be coupled to the base 110 by the second adhesive 182.
  • the coupling between the base 110 and the collection chamber 130 can be configured to contain urine in the internal cavity 135 and inhibit (or prevent leakage) of urine out of the internal cavity 135.
  • the second adhesive 182 can extend along substantially all of a circumference of the rim 133. This can be beneficial in implementations in which the base 110 is configured to contact the entire circumference of the rim 133 as this can help to provide a seal along the entire interface between the base 110 and the collection chamber 130.
  • the second adhesive 182 can extend along only a portion of the circumference of the rim 133. For instance, if the user is in a sitting position, it may be desirable for an uppermost portion of the interface between the base 110 and the collection chamber 130 to be decoupled (e.g., for venting and/or patient comfort). Additionally or alternatively, in some implementations, the base 110 can include a gap at a superior end of the base 110, and the second adhesive 182 can be omitted from a portion of the rim 133 that extends across the gap in the base 110 to avoid the second adhesive 182 contacting the skin of the user.
  • a third adhesive 184 can be provided on a superior portion of the collection chamber 130 to couple the superior portion of the collection chamber 130 to the body of the user above a superior end of the base 110 and/or at a gap in the base 110.
  • the second adhesive 182 and the third adhesive 184 can provide a secure seal between the urine management device 100 and the user, inhibiting (or preventing) any urine inside of the internal cavity of the collection chamber 130 from leaking out.
  • the second adhesive 182 and the third adhesive 184 can be different types of adhesive. For instance, the second adhesive 182 can have a stronger adhesion strength than the third adhesive 184.
  • the collection chamber 130 can have a size and shape that is adapted to loosely envelope the penis of the user. This can provide for improved comfort relative to condom catheters, which require a more snug fit to be retained on the penis.
  • the collection chamber 130 can be arranged to loosely envelope the penis, at least in part, because of the features of the base 110 that assist in retaining the urine management device 100 on (or in a particular position with respect to) the penis.
  • the collection chamber 130 is formed from a suction resistant material. This ensures that the collection chamber 130 maintains its shape and functionality, even under varying pressure conditions, providing reliable urine collection and minimizing the risk of leaks or malfunctions.
  • the suction resistant material can include a thermoformed polymer material that is flexible and transparent.
  • the collection chamber 130 made from this suction-resistant material, can provide both comfort and support to the users, providing ease of use and effective urine collection.
  • the urine management device 100 can also include a hinge 140 that is configured to hingedly couple the collection chamber 130 to the base 110.
  • the collection chamber 130 can be configured to rotate about the hinge 140 between an open position and close position. When the collection chamber 130 is in the open position, the urine management device 100 is configured to provide greater access to the base 110. This can help facilitate coupling the base 110 to the user.
  • the collection chamber 130 can be moved from the open position to the closed position and coupled to the base 110. In this configuration, the collection chamber 130 can capture and direct urine towards an outlet 150 (which is described in further detail below).
  • Hingedly coupling the collection chamber 130 to the base 110 can beneficially help to improve alignment of the collection chamber 130 and the base 110 when coupling the collection chamber 130 and the base 110. It can additionally or alternatively provide for easier operation of the urine management device 100.
  • the base 110 and the collection chamber 130 can omit the hinge 140.
  • the base 110 and the collection chamber 130 can be coupled to each other by only the second adhesive 182 and/or the third adhesive 184. This can simplify a manufacturing process and/or reduce cost.
  • the urine management device 100 also includes a diverter 145 coupled to the base 110 at a lower portion of the aperture 113 of the base 110.
  • the diverter 145 is configured to be positioned below the penis of the user and guide urine discharged from the penis of the user into the internal cavity 135 of the collection chamber 130.
  • the diverter 145 can help inhibit the urine from negatively impacting the seal between the urine management device 100 and the user (e.g., due to the urine contacting the second adhesive 182 at a position at which the penis is located in the internal cavity).
  • the diverter 145 can be made from a silicone material.
  • the diverter 145 can define a recessed channel that extends between a proximal end of the diverter 145 and a distal end of the diverter 145. This can help to support and maintain a position of the penis on the diverter 145 and/or guide the urine along the diverter 145 and into the collection chamber 130.
  • the recessed channel of the diverter 145 can have a concave shape.
  • the diverter 145 can include a proximal portion that extends proximally from the proximal side of the base 110.
  • the proximal portion of the diverter 145 can extend toward the body of the user such that the diverter 145 can be positioned below the penis of the user. This can be beneficial for users with a retracted penis as at least a portion of the penis may be proximal of the portions of the skin at which the base 110 is coupled.
  • the diverter 145 can help to (i) support the penis by lifting it away from surrounding skin folds, (ii) assisting in directing the urine through the aperture 113 in the base 110, (iii) improving stability of the penis to help maintain the penis is a predetermined position relative to the base 110 and/or the collection chamber 130, (iv) reduce skin contact between the penis and surrounding skin folds (e.g., which can help inhibit maceration and other skin-related issues caused by prolonged exposure to moisture), and/or (v) assisting in maintaining the integrity of the second adhesive 182.
  • the diverter 145 can additionally or alternatively include a distal portion that extends distally from the distal side of the base 110. This can help to guide the urine over the base 110 and/or the second adhesive 182. Additionally, in some instances in which the penis is longer than the proximal portion of the diverter 145, the distal portion of the diverter 145 can help to support a portion of the penis that extends distally of the base 110, which can help to improve comfort.
  • the distal portion of the diverter 145 can be configured such that urine flowing off of the distal end of the diverter 145 is positioned closer to the outlet 150 than other examples in which the diverter 145 omits the distal portion of the diverter 145. This can help to more directly guide the urine toward the outlet 150.
  • the diverter 145 can extend a first distance from the distal side of the base 110 into the internal cavity 135 of the collection chamber 130, and a second distance from the proximal side of the base 110 toward the user's body.
  • the first and second distances can be different lengths. In other examples, the first and second distances can be the same. This configuration ensures that the diverter effectively channels urine into the collection chamber, even when the penis is retracted or the skin folds make it difficult to achieve a proper seal.
  • the urine management device 100 can include the outlet 150 for egressing urine from the internal cavity 135 of the collection chamber 130.
  • the outlet 150 can be coupled to a drain tube (described further below with reference to Figure 8) at an inferior-most point of the collection chamber 130.
  • the collection chamber 130 is configured to manage and divert urine discharged from the body of the user to the outlet 150.
  • the urine management devices 100 described herein are easy to securely attach and can keep the skin relatively dry (i.e., with minimal contact with urine). This helps reduce (or prevent) skin breakdown and infection.
  • the diverter 145 is configured to guide (e.g., divert) the urine discharged from the penis of the user into the internal cavity 135 of the collection chamber 130.
  • the collection chamber 130 can then direct the urine toward the outlet 150 that is suitable for egressing the urine from the internal cavity 135 of the collection chamber 130.
  • the urine management device 100 can reduce (or minimize) contact between the user’s penis and the urine in the urine management device 100, thereby improving sanitary conditions, reducing the risk of infection, and/or improving user comfort.
  • the arrangement of the base 110 and the collection chamber 130 can provide a more universal fit for a relatively broad range of the male population by securing the urine management device 100 to the user via a dynamically adjustable aperture 113 proximal of a relatively large opening 136 in the collection chamber 130.
  • Figures 2-6 an implementation of the urine management device 100 of Figure 1 is depicted, according to an example.
  • Figure 2 illustrates a perspective view of the implementation of the urine management device 100 shown in Figure 1 in an open position
  • Figure 3 illustrates a perspective view of the urine management device 100 in a closed position
  • Figure 4 illustrates a distal side of the base 110 of the urine management device 100 in an open position
  • Figure 5 illustrates the diverter 145 of the urine management device 100 shown in Figures 2-4 with the base 110 and the collection chamber 130 in the open position
  • Figure 6 depicts a proximal side 111 of the base 110 of the urine management device 100 shown in Figures 2-4, according to an example.
  • the urine management device 100 includes the base 110, the collection chamber 130, and the hinge 140.
  • the base 110 is configured to couple to a body of a user and includes the proximal side 111 (shown in Figure 6) and a distal side 112.
  • the proximal side 111 of the base 110 includes the first adhesive 180 that is configured to adhere the base 110 to the body of the user.
  • the base 110 includes the aperture 113 that extends through the proximal side 111 and the distal side 112.
  • the base 110 is also configured to extend around the penis of the user when the penis of the user is positioned in the aperture 113 of the base 110. Further detail regarding the base 110 is described below with reference to Figure 6.
  • the urine management device 100 includes the collection chamber 130.
  • the collection chamber 130 includes a proximal end 131 and a distal end 132.
  • the proximal end 131 of the collection chamber 130 is configured to contact the distal side 112 of the base 110.
  • the rim 133 is provided, and the liquid-impermeable wall 134 extends distally from the rim 133.
  • An inner surface of the liquid-impermeable wall 134 has a concave shape such that the liquid-impermeable wall 134 defines an internal cavity 135 that is recessed from the rim 133.
  • the rim 133 defines the opening 136 that provides access to the internal cavity 135.
  • the second adhesive 182 is configured to couple the rim 133 of the collection chamber 130 to the distal side 112 of the base 110.
  • the second adhesive 182 is provided along a perimeter of the proximal end 131 of the collection chamber 130 (e.g., along the rim 133) to provide a seal when the collection chamber 130 and the base 110 are adhered to each other.
  • the second adhesive follows the profile and or shape of the base 110 such as to align the second adhesive 182 with the base 110, providing a complete and secure seal.
  • the second adhesive 182 is on the rim 133 prior to coupling the collection chamber 130 to the base 110.
  • the urine management device 100 can also include a release liner covering the second adhesive 182 to help mitigate prematurely or inadvertently adhering the collection chamber 130 to an object prior to coupling the collection chamber 130 to the base 110.
  • the release liner can be removed from the second adhesive 182 and the collection chamber 130, and then the collection chamber 130 can be moved from the open position to the closed position to couple the collection chamber 130 to the base 110.
  • the second adhesive 182 can be provided on the base 110 instead of the collection chamber 130 prior to coupling the base 110 and the collection chamber 130 to each other. However, it may be more beneficial to provide the second adhesive 182 on the collection chamber 130 because the rim 133 has a smaller surface area than the base 110, which can help to provide greater flexibility in positioning the collection chamber 130 relative to the base 110 while maintaining the seal.
  • the second adhesive 182 is configured to couple the rim 133 of the collection chamber 130 to the distal side 112 of the base 110.
  • the second adhesive 182 can be a stronger adhesive than the first adhesive 180 since the second adhesive 182 is not in contact with the body of a user and is not configured to adhere to the body of the user.
  • the first adhesive 180 and the third adhesive 184 can be the same type of adhesive and/or have the same strength of adhesion.
  • the urine management device 100 can additionally or alternatively include a release liner covering the first adhesive 180 and/or a release liner covering the third adhesive 184.
  • the release liner(s) can be removable from the first adhesive 180 and/or the third adhesive 184 to expose the first adhesive 180 and/or the third adhesive 184. Accordingly, the release liner(s) can help to mitigate prematurely or inadvertently adhering the base 110 and/or the collection chamber 130 to an object prior to coupling the base 110 and/or the collection chamber 130 to the body of the user.
  • the collection chamber 130 of the urine management device 100 includes a superior portion 137 and an inferior portion 138.
  • the third adhesive 184 is provided on the superior portion 137 of the collection chamber 130 and is configured to couple the superior portion 137 of the collection chamber 130 to the body of the user above the superior end 114 of the base 110.
  • the proximal side 111 of the base 110 is first coupled to the body of the user by the first adhesive 180.
  • the collection chamber 130 is coupled to the distal side 112 of the base HO by the second adhesive 182, and the third adhesive 184 couples the superior portion 137 of the collection chamber 130 to the body of the user above the superior end 114 of the base 110.
  • the third adhesive 184 couples the superior portion 137 of the collection chamber 130 to the body of the user above the superior end 114 of the base 110.
  • the collection chamber 130 is formed from a suctionresistant material.
  • the suction-resistant material can comprise of a thermoformed polymer material.
  • the thermoformed polymer material can be flexible and transparent.
  • the collection chamber 130 includes a suction -resistant body that is configured to withstand the applied suction created by a vacuum (e.g., applied by a vacuum device at the outlet 150) when the urine management device 100 is in use without collapsing, while also allowing visibility into the collection chamber 130 to monitor the contents.
  • the urine management device 100 includes the hinge 140 that is configured to couple the collection chamber 130 to the base 110.
  • the collection chamber 130 is configured to rotate about the hinge 140 between the open position and the closed position.
  • the open position allows for easy application, cleaning, and maintenance of the urine management device 100, while the closed position ensures a secure and leak-proof connection during use.
  • the hinge 140 is positioned at the inferior portion 138 of the collection chamber 130. Specifically, the hinge 140 is section 142 of the rim 133 located at the inferior portion 138 of the collection chamber 130. A section 142 of the rim 133 is coupled to an inferior base portion 116 of the base 110. For example, when the collection chamber 130 is moved from the open position to the closed position, the section 142 of the rim 133 flexes to accommodate this movement. As a result, the collection chamber 130 pivots smoothly between the open and closed positions, ensuring ease of use and secure attachment during operation.
  • the urine management device 100 includes the diverter 145.
  • the diverter 145 is coupled to the base 110 at the lower portion of the aperture 113 of the base 110.
  • the diverter 145 is configured to guide urine discharged from the penis of the user into the internal cavity 135 of the collection chamber 130.
  • the urine can be disposed out of the collection chamber 130 via the outlet 150.
  • the diverter 145 is further described below with reference to Figure 5.
  • the urine management device 100 includes the outlet 150.
  • the outlet 150 is positioned at the inferior portion 138 of the collection chamber 130.
  • the outlet 150 can be positioned at an inferior-most point 152 of the collection chamber 130. For example, by positioning the outlet 150 near or at the inferior- most point 152 of the collection chamber 130, pooling of urine at the inferior portion 138 can be reduced (or minimized).
  • the outlet 150 is suitable to be coupled to the drain tube (described below with reference to Figure 8).
  • the outlet 150 can include a thread for threadably coupling with the drain tube.
  • the outlet 150 can include a hose barb and/or a Luer lock for coupling with the drain tube.
  • a vacuum device (described below with reference to Figure 8) can apply a vacuum pressure to the drain tube coupled to the outlet 150 to assist in directing the urine from the outlet 150 to a waste collection reservoir (described below with reference to Figure 8).
  • the urine management device 100 can also include a vent 160.
  • the vent 160 is positioned at a top portion 162 of the collection chamber 130 and configured to allow airflow into and out of the urine management device 100.
  • the vent 160 ensures proper ventilation, inhibiting pressure build-up inside the collection chamber 130 and allowing the urine management device 100 to function efficiently. This airflow helps to maintain a balanced pressure environment within the collection chamber 130, reducing the risk of leaks or malfunctions during use.
  • Figure 5 illustrates the diverter 145 of a urine management device 100 that is in an open position.
  • the diverter 145 is coupled to the base 110 at the lower portion of the aperture 113 of the base 110.
  • the diverter 145 can include the distal portion 146 that extends distally from the distal side 112 of the base 110. Additionally, the diverter 145 can include the proximal portion 147 that extends proximally from the proximal side 111 of the base 110.
  • the distal portion 146 of the diverter 145 protrudes a first distance DI from the distal side 112 of the base 110 into the internal cavity 135 of the collection chamber 130.
  • the distal portion 146 can help to guide the urine over the base 110 and/or the second adhesive 182 into the collection chamber 130.
  • the distal portion 146 of the diverter 145 can help to support a portion of the penis that extends distally of the base 110, which can help to improve comfort.
  • the proximal portion 147 of the diverter 145 protrudes a second distance D2 from the proximal side 111 of the base 110 toward the body of the user.
  • the proximal portion 147 of the diverter 145 can extend toward the body of the user such that the diverter 145 can be positioned below the penis of the user. This can be beneficial for users with a retracted penis as at least a portion of the penis may be proximal of the portions of the skin at which the base 110 is coupled.
  • the first distance DI of the distal portion 146 and the second distance D2 of the proximal portion 147 maybe 2 inches (i.e., 5.08 centimeters) or less.
  • the diverter 145 is positioned in a manner that optimizes its functionality while maintaining a compact and user-friendly design. This arrangement ensures efficient performance without intruding excessively into the internal cavity 135 or extending too far towards the user, thereby enhancing the overall effectiveness of the collection chamber 130 and providing comfort to the user by minimizing any intrusive effect or discomfort during use.
  • the first distance DI and the second distance D2 can be the same length. Additionally, in some examples, the first distance DI and the second distance D2 can be different in length. For example, the first distance DI can be greater than the second distance D2, ensuring that the diverter 145, protruding the first distance DI from the distal side 112 of the base 110 into the internal cavity 135, is sufficiently inside the internal cavity 135 of the collection chamber 130. Further, the second distance D2 can be less than the first distance DI, thus ensuring that the diverter 145, protruding the second distance D2 from the proximal side 111 of the base 110 toward the body of the user, does not cause any discomfort to the user.
  • the diverter 145 can also be made of silicone material.
  • silicone is selected for its flexibility and rigidity, which allow the diverter 145 to conform comfortably to various shapes while maintaining structural stability. This balance of flexibility and rigidity enhances user comfort and ensures durability. Additionally, silicone's non-reactive and hypoallergenic properties further contribute to the user’s safety and comfort.
  • the diverter 145 can help to: (i) support the penis by lifting it away from surrounding skin folds; (ii) assisting in directing the urine through the aperture 113 in the base 110; (iii) improving stability of the penis to help maintain the penis is a predetermined position relative to the base 110 and/or the collection chamber 130; (iv) reduce skin contact between the penis and surrounding skin folds (e.g., which can help prevent maceration and other skin-related issues caused by prolonged exposure to moisture); and/or (v) assisting in maintaining the integrity of the second adhesive 182.
  • Figure 6 illustrates a proximal side of a base of a urine management device, according to an example of the present disclosure.
  • Figure 6 depicts the shape (e.g., profile) of the base 110.
  • the base 110 includes the inferior base portion 116, with a first lateral base portion 117 extending in a superior direction from the inferior base portion 116 on a first lateral side 118 of the aperture 113.
  • a second lateral base portion 119 extends in the superior direction from the inferior base portion 116 on the second lateral side 120 of the aperture 113.
  • a gap 121 is defined between the first lateral base portion 117 and the second lateral base portion 119 at the superior end 114 of the base 110.
  • the gap 121 is configured to facilitate positioning of the base 110 relative to the penis of the user.
  • the base 110 can have a shape selected from a group consisting of a polygon, a circle, an oval, or any polygon with an open top, a circle with an open top, and an oval with an open top.
  • the base is configured to extend around the penis, providing flexibility and adaptability to different sizes and shapes for enhanced comfort and effectiveness.
  • the base 110 can be formed from a flexible foam material.
  • the flexible foam base 110 can help provide both comfort and adaptability, thus allowing for a snug fit against the body of the user.
  • This flexible nature of the base 110 can help the base 110 contour to various body shapes and movements.
  • the foam material can have varying degrees of firmness or softness. This adaptability can provide both comfort to the user and provide that the base 110 remains securely in place during use, inhibiting unnecessary shifting or movement.
  • Figure 7 depicts another implementation of the urine management device 100 described above with respect to Figure 1, according to another example.
  • the urine management device 100 shown in Figure 7 is substantially similar or identical to the implementation of the urine management device 100 shown in Figures 2-6, except the urine management device 100 shown in Figure 7 also includes a gasket ridge 170 on the distal side 112 of the base 110.
  • the gasket ridge 170 is configured to provide a barrier that can help to mitigate contact between urine in the internal cavity 135 of the collection chamber 130 and the second adhesive 182 at an interface between the rim 133 and the base 110.
  • the gasket ridge 170 can extend (i) around at least a portion of the aperture 113 of the base 110, and (ii) at an inner portion of the distal side 112 of the base 110 that is inwardly disposed (e.g., closer to the aperture 113 than an outer periphery of the base 110) relative to an outer portion of the distal side 112 of the base 110 at which the rim 133 is configured to couple to the base 110.
  • the system 250 includes the urine management device 100 described above. Additionally, the system 250 includes a drain tube 252, a waste collection reservoir 254, and a vacuum device 256. [0077] A first end 258 of the drain tube 252 is coupled to the outlet 150 of the collection chamber 130 of the urine management device 100.
  • the drain tube 252 can include a thread, a Luer lock, and/or other feature for coupling the drain tube 252 to the outlet 150.
  • the drain tube 252 can be a flexible material to facilitate directing the drain tube away from the user’s body. It can be beneficial to direct the drain tube 252 away from the user’s body (e.g., off the side of a bed) to reduce (or prevent) the drain tube 252 from accidental pulling and leakage resulting from such pulling.
  • the waste collection reservoir 254 is coupled to a second end 260 of the drain tube 252 to receive the urine from the drain tube 252.
  • the waste collection reservoir 254 can be a leg bag, a drainage bag, or other container.
  • the waste collection reservoir 254 can include a hanger and/or another structure for coupling the waste collection reservoir 254 to a patient support surface 262 (e.g., a bed and/or a wheelchair) used by the patient.
  • the waste collection reservoir 254 can be a sealed container. This can, for example, reduce (or minimize) a risk of spillage and/or contamination.
  • the waste collection reservoir 254 can be disposable. In other examples, the waste collection reservoir 254 can be reusable. For instance, the waste collection reservoir 254 can be configured to be sterilized after a use and reused.
  • the vacuum device 256 can apply a vacuum pressure to the drain tube 252 to assist in directing the urine from the outlet 150 to the waste collection reservoir 254.
  • the vacuum device 256 can include an air pump or other vacuum source, which is fluidly coupled to the waste collection reservoir 254 by an air tube 264.
  • the air tube 264 can also be made of a flexible material.
  • the vacuum device 256 can be a wall vacuum integrated into a room of a medical facility. In other examples, the vacuum device 256 can be integrated with the patient support surface 262. For instance, the vacuum device 256 can be integrated with a bed in a medical facility.
  • the system can also include an occlusion clip for selectively controlling the flow of urine in the drain tube.
  • the occlusion clip can provide for stopping the flow of urine in the drain tube to facilitate changing and/or emptying the waste collection reservoir.
  • the urine management device 100 can be attached to the user. First, the urine management device 100 can be positioned to align the aperture 113 with a head of a penis of the user. Next, the urine management device 100 can be moved proximally towards the user to insert the penis through the aperture 113.
  • the gap 121 defined between the first lateral base portion 117 and the second lateral base portion 119 at the superior end 114 of the base 110, can be expanded or contracted to accommodate different sizes and configurations.
  • the urine management device 100 can be moved further proximally until the first adhesive 180 of the base 110 contacts and attaches to a pelvic area of the user. Once the base 110 is adhered, via the first adhesive 180, to the pelvic area of the user, the collection chamber can closed to adhere, via the second adhesive 182, to the distal side 112 of the base 110.
  • the third adhesive 184 couples the superior portion 137 of the collection chamber 130 to the body of the user above the superior end 114 of the base 110.
  • the drain tube 252 can be coupled to the outlet 150 at the first end 258 and the waste collection reservoir 254 at the second end 260.
  • the vacuum device 256 can also be connected to the waste collection reservoir 254 by the air tube 264. The vacuum device 256 can then be operated to apply the vacuum pressure at the outlet 150 (e.g., via the air tube 264, the waste collection reservoir 254, and the drain tube 252).
  • the urine management device 100 can beneficially be attached to users having penises of various sizes and/or shapes.
  • a user may have a condition, which is known as a “retracted penis”.
  • a user’s penis may not extend through the aperture 113 and/or the user’s penis may extend only slightly through the aperture 113 such that urine discharged by the user may contact the base 110.
  • the urine management device 100 can include a diverter 145 that is adapted to divert discharged urine away from the user into the collection chamber 130.
  • FIG. 9 a flowchart for a process S300 for collecting urine is illustrated according to an example.
  • the process includes positioning the base 110 of the urine management device 100 around the penis of the user. During this process, the urine management device 100 is in an open position (i.e., the collection chamber 130 is not coupled to the base 110).
  • the aperture 113 of the base can be expanded.
  • the gap 121 defined between the first lateral base portion 117 and the second lateral base portion 119 at the superior end 114 of the base 110, can be expanded or contracted to accommodate different sizes and configurations.
  • the first lateral base portion 117 can be moved or positioned relative to the second lateral base portion 119 to expand a size of the aperture 113 in the base 110.
  • the process includes adhering the base 110 to the body of the user using the first adhesive 180. This secures the base 110, creating a tight seal between the base 110 and the user's body.
  • the process S300 includes positioning the collection chamber 130 onto the base 110, which is positioned around the user's penis, so that the penis is received into the internal cavity 135 of the collection chamber 130. Specifically, the collection chamber 130 is adhered to the base 110 via the second adhesive. As a result, the collection chamber 130 and the base 110 create a tight seal between each other.
  • the process S300 includes adhering the third adhesive 184 to the body of the user at block S307.
  • the third adhesive 184 couples the superior portion 137 of the collection chamber 130 to the body of the user above the superior end 114 of the base 110.
  • the process S300 can include receiving urine in the collection chamber 130 at block S309. Specifically, urine that is exiting the user’s penis is guided into the collection chamber 130, via the diverter 145, even when the urine stream is weak or reduced due to skin folds, the penis, or the user's body.
  • the process S300 can include egressing, via an outlet 150 of the collection chamber 130, the urine from the internal cavity 135 of the collection chamber 130.
  • the process S300 can also include coupling, via a tube, a vacuum device to the outlet 150 of the urine management device 100 at block S313.
  • the process S300 can include operating the vacuum device to apply, via the tube, a vacuum pressure to the urine management device.

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

Abstract

Un dispositif de gestion d'urine comprend une chambre de collecte accouplée de manière articulée à une base. La base comprend un côté proximal et un côté distal. Le côté proximal de la base est conçu pour entrer en contact avec une zone pelvienne d'un utilisateur et le côté distal fait face à la chambre de collecte. Pendant l'application, la chambre de collecte peut être repliée pour ne pas gêner, permettant à un clinicien un accès complet pour fixer la base à la zone pelvienne de l'utilisateur. Une fois que la base est solidement fixée à la zone pelvienne de l'utilisateur, la chambre de collecte peut être repliée et couplée au côté distal de la base, créant un joint d'étanchéité sécurisé. La chambre de collecte est conçue pour (i) collecter l'urine sortant d'une anatomie de l'utilisateur et (ii) diriger l'urine dans la chambre de collecte vers une sortie.
PCT/US2025/039906 2024-08-05 2025-07-30 Dispositifs, systèmes et procédés de gestion d'urine Pending WO2026035497A1 (fr)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5300052A (en) * 1991-11-01 1994-04-05 Alcare Co., Ltd. Urinary collector for men
CA3091062A1 (fr) * 2018-02-14 2019-08-22 Sage Products, Llc Dispositifs et systemes de collecte d'urine
WO2021231532A1 (fr) * 2020-05-14 2021-11-18 Cm Technologies, Inc. Dispositif d'élimination de fluide
US20220096263A1 (en) * 2020-09-30 2022-03-31 Sabry Gabriel External urine bags and methods of making and using the same
US20230270582A1 (en) * 2020-07-17 2023-08-31 Coloplast A/S A male urinary incontinence device
EP4240296B1 (fr) * 2022-01-28 2024-04-10 Purewick Corporation Ensembles et systèmes de collecte de fluide masculin

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5300052A (en) * 1991-11-01 1994-04-05 Alcare Co., Ltd. Urinary collector for men
CA3091062A1 (fr) * 2018-02-14 2019-08-22 Sage Products, Llc Dispositifs et systemes de collecte d'urine
WO2021231532A1 (fr) * 2020-05-14 2021-11-18 Cm Technologies, Inc. Dispositif d'élimination de fluide
US20230270582A1 (en) * 2020-07-17 2023-08-31 Coloplast A/S A male urinary incontinence device
US20220096263A1 (en) * 2020-09-30 2022-03-31 Sabry Gabriel External urine bags and methods of making and using the same
EP4240296B1 (fr) * 2022-01-28 2024-04-10 Purewick Corporation Ensembles et systèmes de collecte de fluide masculin

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