SUCH DEVICES

RELATED APPLICATION DATA

[0001] The present application is related to co-pending U.S. provisional application

Serial No. 63/209,999, filed June 11, 2021, the entire disclosure of which is expressly incorporated by reference herein.

TECHNICAL FIELD

[0002] 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.

BACKGROUND

[0003] Current male incontinence devices in the market are generally designed for male patients with intact or “normal” anatomy. These devices depend on gravity to move urine away from the patient's skin. Current male external urinary collection systems (e.g., condom catheters, ReliaFit Male Urinary Device), however, don’t generally work for bed- bound, incontinent male patients with retractile (buried) or uncircumcised penises.

[0004] It is desirable to minimize the use of indwelling Foley catheters to reduce rates of Catheter- Acquired Urinary Tract Infection (CAUTI) in incontinent hospitalized patients. It has been observed that some male anatomies (e.g., men with retractable and uncircumcised penises) are not conducive to using other devices, such as condom catheters or ReliaFit external urinary devices.

[0005] During a single shift with a patient that is not appropriate for a condom catheter, a bedside nurse may have to change the patient every hour due to failure of the condom catheter when the patient urinates, which consumes additional nurse time. Patients with retractile penis also tend to be obese, which increases risk of physical injuries to the nurse when the nurse tries to move the patient to change soiled linen. Nursing time to address condom catheter failures in this patient population takes away time for the nurse to complete critical nursing tasks across his/her patient assignment. [0006] Nurses have tried other workarounds, such as creating a diaper; however, this is a suboptimal solution since a diaper puts urine in direct contact with the patient's skin, which can increase risk of skin injuries.

[0007] Accordingly, devices and methods for collecting urine in male patients with retractile (buried) or uncircumcised penises would be useful.

SUMMARY

[0008] 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.

[0009] In accordance with one example, 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). Alternatively, 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).

[00010] In accordance with another example, a device is provided 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. In one example, 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. [00011] In accordance with still another example, a system is provided 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.

[00012] In accordance with still another example, a method is provided for collecting urine from a male subject that 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.

[00013] Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS [00014] It is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which: [00015] FIG. 1 A shows an exemplary urine collection device.

[00016] 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.

[00017] 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.

[00018] The drawings are not intended to be limiting in any way, and it is contemplated that various examples of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

[00019] The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive. [00020] Before the examples are described, it is to be understood that the invention is not limited to particular examples described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular examples only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[00021] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[00022] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and exemplary methods and materials are now described.

[00023] It must be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a compound” includes a plurality of such compounds and reference to “the polymer” includes reference to one or more polymers and equivalents thereof known to those skilled in the art, and so forth.

[00024] Certain ranges are presented herein with numerical values being preceded by the term “about.” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.

[00025] Turning to the drawings, 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.

[00026] For example, as shown in FIG. IB, 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. In one example, 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. Alternatively, 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. [00027] 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. In addition or alternatively, 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.

[00028] Adhesive may be provided on an exterior surface of the pouch 20 adjacent the opening 22 to secure the pouch 20. For example, as shown in FIG. 1 A, 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. [00029] Alternatively, as shown in FIG. IB, 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. IB, 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 (or other adhesive) 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. [00030] Optionally, 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. For example, an elastic band, drawstring, or other element (not shown) 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. For example, 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). Alternatively, 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.

[00031] In another alternative, 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. In still another alternative, 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.

[00032] In the examples shown in FIGS. 1 A and IB, 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. [00033] For example, as shown in FIG. 1A, 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. Alternatively, as shown in FIG. IB, 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.

[00034] In either case, the second end 34 of the tube 30 may be connectable to a length of suction tubing 50. Generally, 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. For example, one or both of 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.

[00035] In one example, 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. Alternatively, 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. In a further alternate, 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.

[00036] In one example, 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). In this example, 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. In addition or alternatively, a valve (not shown) may be provided on the tube 30, e.g., on the second end 34 of the tube 30.

[00037] 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. For example, 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. In the example shown in FIG. 1 A, 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.

[00038] Alternatively, as shown in FIG. IB, 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. For example, 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.

[00039] 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. In addition or alternatively, 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. Optionally, 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.

[00040] The sponge 40 may have sufficient size and/or porosity to at least partially fill the interior 21. For example, 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. In addition or alternatively, 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).

[00041] As shown in FIG. 2, during use, 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. Thus, in the case of retractile or buried penis, 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. For example, if the vacuum is provided by a port of a vacuum line, e.g., on a headwall of a facilitate treating the subject (not shown), 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. For example, 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. When suction is applied, the vacuum may collapse the sponge 40 within the interior 21, thereby facilitating evacuating urine within the pouch. 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. As desired, e.g., periodically, the pouch 20 may be removed from the subject and replaced with a new device 10, and the old pouch 20 discarded.

[00042] While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.