Devices, systems, and methods for urine diversion

Abstract

A urine diversion device includes a diversion member extending from a proximal end to a distal end. The diversion member includes an opening that is configured to provide access to an internal cavity of the diversion member. The urine diversion device also includes a spacer in the internal cavity. The spacer includes one or more preferential separation regions in at least one of a first major surface or a second major surface. The urine diversion device also includes one or more attachment members configured to couple the diversion member to a user, and an outlet for egressing urine from the internal cavity of the diversion member. The diversion member is suitable to direct urine toward the outlet.

Description

Devices, Systems, and Methods for Urine DiversionCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims the benefit of priority to U.S Provisional Application No. 63 / 531,586, filed August 9, 2023, the contents of which is hereby incorporated by reference in its entirety.FIELD

[0002] The present disclosure generally relates to devices and systems for diverting urine discharged from the body of a user.BACKGROUND

[0003] Under various circumstances, a user may have limited or impaired mobility such that ordinary urinary functions and processes are rendered difficult (or impossible). For example, a person may have impaired mobility due to a disability or may be bedridden due to an injury or illness. In another example, a person may be subject to restricted occupational conditions under which the person has limited mobility. Also, for example, urine collection may be needed for monitoring purposes, such as for monitoring inputs and outputs in a clinical setting (e.g., in an intensive care unit, or for other clinical and / or laboratory testing).

[0004] Various approaches have been developed to address some of the problems or circumstances related to impaired or restricted urinary processes. However, prior approaches suffer from problems or limitations of their own. Internal urinary catheters, for example, can address problems arising from urinary incontinence or limited mobility, but urinary catheters can often be uncomfortable and can contribute to complications (for example, infections). Bed pans, as another example, are containers occasionally used for collecting urinary output of a bedridden person (such as a patient at a health care facility), but bed pans can contribute to patient discomfort, spillage, and issues related to sanitation or hygiene.

[0005] Other more recent approaches to urinary collection have been developed, which include a urine diversion device configured to be placed external to, but in contact with the body for collecting and directing a fluid receptacle. However, the recent approaches also present challenges, such as in maintaining the placement of the device in appropriate contact with the body of a user, resulting in potential leakage and patient discomfort.SUMMARY

[0006] In an example, a urine diversion device includes a diversion member extending from a proximal end to a distal end. The diversion member includes an opening that is configured to provide access to an internal cavity of the diversion member. The urine diversion device also includes a spacer in the internal cavity. The spacer includes a proximal-spacer end, a distal-spacer end, a first lateral side, a second lateral side, a first major surface extending between the proximal-spacer end, the distal-spacer end, the first lateral side, and the second lateral side, a second major surface extending between the proximal-spacer end, the distal- spacer end, the first lateral side, and the second lateral side, and one or more preferential separation regions in at least one of the first major surface or the second major surface. The urine diversion device also includes one or more attachment members configured to couple the diversion member to a user, and an outlet for egressing urine from the internal cavity of the diversion member. The diversion member is suitable to direct urine toward the outlet.

[0007] In another example, a urine diversion device includes a diversion member defining an internal cavity. The diversion member includes a bottom wall extending between a proximal end and a distal end, a top wall extending between a proximal end and a distal end, and a proximal wall extending from the proximal end of the bottom wall to the top wall to define a proximal-most end of the internal cavity. The bottom wall defines an opening that is configured to receive a penis of a user into the internal cavity. The urine diversion device also includes an outlet for egressing urine from the internal cavity of the diversion member. The diversion member is suitable to direct urine received in the internal cavity distally toward the outlet. The bottom wall includes a first attachment member that is configured to couple the diversion member to the user. The top wall includes a second attachment member that is configured to couple the diversion member to the user.

[0008] In another example, a urine diversion device includes a diversion member extending from a proximal end to a distal end. A bottom wall of the diversion member includes an opening that provides access to an internal cavity of the diversion member. The urine diversion device also includes one or more attachment members configured to couple the diversion member to a user, an outlet for egressing urine from the internal cavity of thediversion member, and a hydrophobic layer in the internal cavity of the diversion member. The hydrophobic layer is configured to move urine distally toward the outlet

[0009] In another example, a urine diversion device includes a diversion member having a top wall and a bottom wall that extend between a proximal end and a distal end. The top wall is coupled to the bottom wall at a first lateral side and a second lateral side of the diversion member. The diversion member includes an opening extending through the bottom wall and providing access to an internal cavity of the diversion member. The urine diversion device also includes one or more attachment members configured to couple the diversion member to a user, and an outlet for egressing urine from the internal cavity of the diversion member. Along a direction from the proximal end toward the distal end, a width of the diversion member (i) increases outwardly away from a center axis of the diversion member along a proximal portion extending from the proximal end to a corner portion at the first lateral side and a corner portion at the second lateral side, and (ii) decreases inwardly toward the center axis from the comer portions to the distal end. The diversion member is configured to direct urine along one of the first lateral side or the second lateral side toward the corner portion at the one of the first lateral side or the second lateral side when the user is laying on their side with the diversion member coupled to the user.

[0010] In another example, a urine diversion device includes a diversion member extending from a proximal end to a distal end. A bottom wall of the diversion member includes an opening that provides access to an internal cavity of the diversion member. The urine diversion device also includes an outlet for egressing urine from the internal cavity of the diversion member. The diversion member is suitable to direct urine toward the outlet. The urine diversion device further includes a first attachment member rotatably coupled to the bottom wall of the diversion member.

[0011] The first attachment member includes a backing member having a first side, a second side, and an aperture extending through the first side and the second side. The first side includes an adhesive that is configured to couple to a skin of a user. The first attachment member also includes a protrusion on one of the second side of the backing member or the bottom wall of the diversion member, and a track structure on another one of the second side of the backing member or the bottom wall of the diversion member. The track structure is coupled to the protrusion such that (i) the track structure constrains movement of the protrusion in a direction extending from the first side toward the second side and (ii) permitscircumferential movement of the protrusion about the aperture of the backing member and the opening of the diversion member.

[0012] In another example, a urine diversion device includes a waistband configured to be worn around a waist of a user, and a diversion member coupled to the waistband. The diversion member defines an internal cavity. The diversion member includes an opening. The diversion member is configured to receive a penis of a user in the internal cavity through the opening. The diversion member includes an outlet that is configured for egressing urine from the diversion member.

[0013] The urine diversion device also includes a leg strap configured to be worm around a leg of the user, and a secondary fluid reservoir coupled to the leg strap. An inlet of the secondary fluid reservoir is coupled to the outlet of the diversion member such that the urine received in the internal cavity of the diversion member flows to the secondary fluid reservoir. The secondary fluid reservoir comprises a secondary outlet that is configured to drain the secondary fluid reservoir.

[0014] In another example, a urine diversion device includes a wearable garment and a diversion member. The wearable garment includes at least one bottom selected from a group consisting of: a pair of underwear, a pair of pants, and a pair of shorts. The diversion member defines an internal cavity. The diversion member includes an opening. The diversion member is configured to receive a penis of a user in the internal cavity through the opening. The diversion member includes an outlet that is configured for egressing urine from the diversion member.

[0015] The urine diversion device also includes an attachment member coupled to the diversion member. The attachment member is configured to couple the diversion member to the user. The diversion member and the attachment member are configured to be between the wearable garment and a skin of the user when the attachment member couples the diversion member to the user.

[0016] The urine diversion device further includes a secondary fluid reservoir coupled to the outlet of the diversion member such that the urine received in the internal cavity of the diversion member flows to the secondary fluid reservoir. The secondary fluid reservoir is coupled to wearable garment. The secondary fluid reservoir includes a secondary outlet that is configured to drain the secondary fluid reservoir.

[0017] In another example, a system includes a urine diversion device, a waste collection reservoir, and a hand-operated pump. The urine diversion device includes a diversion member defining an internal cavity. The diversion member includes an opening. The diversion member is configured to receive a penis of a user in the internal cavity through the opening. The diversion member includes an outlet that is configured for egressing urine from the diversion member. The urine diversion device also includes an attachment member coupled to the diversion member. The attachment member is configured to couple the diversion member to the user.

[0018] The waste collection reservoir is coupled to the outlet of the diversion member by a drain tube. The hand-operated pump is coupled to the waste collection reservoir. The handoperated pump is manually operable to apply suction to at least the drain tube to move fluid from the outlet of the diversion member along the drain tube to the waste collection reservoir.

[0019] The features, functions, and advantages that have been discussed can be achieved independently in various embodiments or may be combined in yet other embodiments further details of which can be seen with reference to the following description and drawings.BRIEF DESCRIPTION OF THE FIGURES

[0020] The novel features believed characteristic of the illustrative embodiments are set forth in the appended claims. The illustrative embodiments, however, as well as a preferred mode of use, further objectives and descriptions thereof, will best be understood by reference to the following detailed description of an illustrative embodiment of the present disclosure when read in conjunction with the accompanying drawings, wherein:

[0021] Figure 1 depicts a simplified block diagram of a urine diversion device, according to an example.

[0022] Figure 2 depicts a system for diverting urine including the urine diversion device of Figure 1, according to an example.

[0023] Figure 3A is an exploded view of the urine diversion device, according to an example.

[0024] Figure 3B is a perspective view of the urine diversion device shown in Figure 3 A, according to an example.

[0025] Figure 3C is a top view of the urine diversion device shown in Figure 3A, according to an example.

[0026] Figure 3D is a side view of the urine diversion device shown in Figure 3 with a bottom side and a top side of a diversion member in an open arrangement at a proximal end, according to an example

[0027] Figure 3E depicts a cross-sectional view of the urine diversion device taken through a line in Figure 3D, according to an example.

[0028] Figures 4A depicts a urine diversion device partially coupled to a user, according to an example.

[0029] Figure 4B depicts the urine diversion device of Figure 4A fully coupled to the user, according to the example.

[0030] Figure 5A depicts a top side of a spacer of a urine diversion device, according to an example.

[0031] Figure 5B depicts a bottom side of the spacer shown in Figure 5A, according to the example.

[0032] Figure 6A depicts a top side of a spacer of a urine diversion device, according to another example.

[0033] Figure 6B depicts a bottom side of the spacer shown in Figure 6A, according to the example.

[0034] Figure 7A depicts a top side of a spacer of a urine diversion device, according to another example.

[0035] Figure 7B depicts a bottom side of the spacer shown in Figure 7A, according to the example.

[0036] Figure 8A depicts a first view of a urine diversion device coupled to a user, according to another example.

[0037] Figure 8B depicts a second view of the urine diversion device shown in Figure 8A, according to the example.

[0038] Figure 9A depicts a first view of a urine diversion device, according to another example.

[0039] Figure 9B depicts a second view of the urine diversion device shown in Figure 9A, according to the example.

[0040] Figure 10A depicts a first view of a urine diversion device, according to another example.

[0041] Figure 10B depicts a second view of the urine diversion device shown in Figure 9A, according to the example.

[0042] Figure 11A depicts the urine diversion device coupled to a user in a first rotational position, according to another example.

[0043] Figure 11B depicts the urine diversion device of Figure 11A coupled to the user in a second rotational position, according to an example.

[0044] Figure 11C depicts a backing member for rotatably coupling a diversion member to a user, according to an example.

[0045] Figure 1 ID depicts a protrusion for rotatably coupling the diversion member to the user, according to an example.

[0046] Figure 1 IE depicts a track for rotatably coupling the diversion member to the user, according to an example.

[0047] Figure 1 IF depicts a first attachment member of the urine diversion device of Figure 11A coupled to a user and the diversion member decoupled from the first attachment member, according to an example.

[0048] Figure 11G depicts the diversion member decoupled from the first attachment member, according to an example.

[0049] Figure 12A depicts a top side of a urine diversion device, according to another example.

[0050] Figure 12B depicts a bottom side of the urine diversion device of Figure 12A, according to the example.

[0051] Figure 12C depicts an exploded view of the urine diversion device of Figure 12 A, according to the example.

[0052] Figure 13 depicts a stub tube according to an example.

[0053] Figure 14 depicts a stub tube according to another example.

[0054] Figure 15 depicts a stub tube according to another example.

[0055] Figure 16 depicts a stub tube according to another example.

[0056] Figure 17 depicts a stub tube according to another example.

[0057] Figure 18 depicts a stub tube according to another example.

[0058] Figure 19 depicts a stub tube according to another example.

[0059] Figure 20 depicts a stub tube according to another example.

[0060] Figure 21 depicts a stub tube according to another example.

[0061] Figure 22A is a perspective view of a port, according to an example.

[0062] Figure 22B is a side view of the port of Figure 22A, according to the example.

[0063] Figure 22C is an end view of the port of Figure 22A, according to the example.

[0064] Figure 22D is a cross-sectional view of the port taken through a line A in Figure 22B, according to an example.

[0065] Figure 22E is an enlarged view of a proximal end of the port shown in Figure 22D, according to the example.

[0066] Figure 23 A is a perspective view of the port, according to another example.

[0067] Figure 23B is a first end view of the port of Figure 23 A, according to the example.

[0068] Figure 23C is a second end view of the port of Figure 23 A, according to the example.

[0069] Figure 23D is a first side view of the port of Figure 23 A, according to the example.

[0070] Figure 23E is a second side view of the port of Figure 23 A, according to the example.

[0071] Figure 23F is a third side view of the port of Figure 23A, according to the example.

[0072] Figure 23G is a fourth side view of the port of Figure 23 A, according to the example.

[0073] Figure 24A depicts a feature for coupling a drain tube to a diversion member, according to an example.

[0074] Figure 24B depicts a feature for coupling a drain tube to a diversion member, according to another example.

[0075] Figure 24C depicts a feature for coupling a drain tube to a diversion member, according to another example.

[0076] Figure 24D depicts a feature for coupling a drain tube to a diversion member, according to another example.

[0077] Figure 25 depicts a urine diversion device including a urine sensor, according to an example.

[0078] Figure 26A depicts a urine diversion device including a diversion member having a plurality of baffles, according to an example.

[0079] Figure 26B depicts a diversion member and the baffles of the urine diversion device shown in Figure 26A along with urine within the diversion member, according to an example.

[0080] Figure 26C depicts a system including the urine diversion device of Figure 26A coupled to a waste collection reservoir by a drain tube, and a waste collection reservoir coupled to a hand-operated pump by an air tube, according to an example.

[0081] Figure 26D depicts a one-way valve of the system shown in Figure 26C with the one-way valve in an open state, according to an example.

[0082] Figure 26E depicts the one one-way valve of the system shown in Figure 26C with the one-way valve in a closed state, according to an example.

[0083] Figure 27A depicts a urine diversion device, according to another example.

[0084] Figure 27B depicts the urine diversion device of Figure 27A coupled to a user, according to an example.

[0085] Figure 28A depicts a urine diversion device in a partially open state, according to another example.

[0086] Figure 28B depicts the urine diversion device of Figure 28 A in a closed state, according to the example.

[0087] Figure 29 illustrates a flowchart for a process for diverting urine, according to an example embodiment.

[0088] Figure 30 illustrates a flowchart for a process for diverting urine that can be performed with the process shown in Figure 29, according to an example.

[0089] Figure 31 illustrates a flowchart for a process for diverting urine that can be performed with the process shown in Figure 29, according to an example.

[0090] Figure 32 illustrates a flowchart for a process for diverting urine that can be performed with the process shown in Figure 29, according to an example.

[0091] Figure 33 illustrates a flowchart for a process for diverting urine that can be performed with the process shown in Figure 29, according to an example.

[0092] Figure 34 illustrates a flowchart for a process for diverting urine that can be performed with the process shown in Figure 29, according to an example.DETAILED DESCRIPTION

[0093] Disclosed embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all of the disclosed embodiments are shown. Indeed, several different embodiments may be described and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are described so that this disclosure will be thorough and complete and will fully convey the scope of the disclosure to those skilled in the art.

[0094] As noted above, recent approaches to urinary diversion have been developed, which include a urine diversion device configured to be placed external to, but in contact with the body for diversion to a fluid receptacle. One such approach is 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.

[0095] Additionally, 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 canbe 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 diversion devices that can address at least some of the drawbacks of existing male external catheters.

[0096] Figure 1 depicts a simplified block diagram of a urine diversion device 100 according to an example. The urine diversion device 100 is configured to be coupled to an exterior of a body of a user (e.g., to a skin of the user). This can help to reduce a risk of urinary tract infections that is associated with indwelling urinary catheters. When the urine diversion device 100 is coupled to the user, the urine diversion device 100 can receive urine discharged from a penis of the user so that the urine can be received and directed along a drain tube to a waste collection device. In this way, the urine diversion device 100 can help to manage incontinence.

[0097] As shown in Figure 1, the urine diversion device 100 includes a diversion member 110. The diversion member 110 defines an internal cavity 112 for receiving the penis of the user and urine discharged from the penis. For example, the diversion member 110 can include one or more walls 114 formed from a fluid impermeable material. The wall(s) 114 can each have an exterior surface and an interior surface, and the interior surface(s) of the walls 114 of the diversion member 110 can at least partially define the internal cavity 112. The exterior surface of the wall(s) 114 can face outwardly from the internal cavity 112.

[0098] Within examples, the diversion member 110 can extend from a proximal end to a distal end. In some examples, the diversion member 110 can have an elongated shape such that a length extending between the proximal end and the distal end is greater than a width, which (i) extends between a first lateral side and a second lateral side of the diversion member 110, and (ii) extends in a direction that is perpendicular to the length. The elongated shape of the diversion member 110 can help to receive penises of various lengths in the internal cavity 112 of the diversion member 110, and direct urine distally away from the user.

[0099] In some examples, the width of the diversion member 110 can taper inwardly along a direction extending from the proximal end of the diversion member 110 toward the distal end of the diversion member 110. This can help to direct the urine received in the internal cavity inwardly toward the drain tube at the distal end and may help to mitigate pooling at thedistal end of the diversion member 110. In other examples, the width of the diversion member 110 can be non-tapered along the direction extending from the proximal end of the diversion member 110 toward the distal end of the diversion member 110.

[0100] Also, within examples, the diversion member 110 can include a top side, a bottom side, the first lateral side between the top side and the bottom side, and the second lateral side between the top side and the bottom side. The top side, the bottom side, the first lateral side, and the second lateral side extend between the proximal end and the distal end of the diversion member 110. When the diversion member 110 is coupled to a user, the bottom side faces in a posterior direction (e.g., towards an anus of the user) and the top side faces in an anterior direction (e.g., away from the anus of the user). In this arrangement, when the diversion member 110 is coupled to the user and the user is laying on a surface of a hospital bed, the bottom side faces the surface of the hospital bed and the top side faces upwardly way from the surface of the hospital bed.

[0101] As described above, the diversion member 110 can include one or more walls 114. In some implementations, the diversion member 110 can be formed from a single sheet of material such that a single wall 114 defines the top side, the bottom side, the first lateral side, and the second lateral side. In other implementations, the diversion member 110 can be formed from a plurality of sheets of material such that a plurality of walls 114 define the top side, the bottom side, first lateral side, and the second lateral side. For instance, in one example, a first sheet of material can form the top side, a second sheet of material can form the bottom side, a first coupling (e.g., a first lateral seam) between the first sheet of material and the second sheet of material can form the first lateral side, and a second coupling (e.g., a second lateral seam) between the first sheet of material and the second sheet of material can form the second lateral side.

[0102] As also shown in Figure 1, the diversion member 110 includes an opening 116 that is configured to provide access to the internal cavity 112 of the diversion member 110. For instance, the opening 116 can extend entirely through the exterior surface and the interior surface of one or more of the wall(s) 114 of the diversion member 110 such that a penis of a user can be inserted and extend through the opening 116 into the internal cavity 112 when the urine diversion device 100 is coupled to the user. When the penis of the user extends through the opening 116 and into the internal cavity 112, the wall(s) 114 of the diversion member 110 can circumscribe at least a head of the penis and receive the urine from the penis in the internal cavity 112 of the diversion member 110. As the wall(s) 114 are formed from a liquidimpervious material, the wall(s) 114 can help to contain the urine the urine diversion device 100.

[0103] In some examples, the opening 116 can be at a proximal-most end of the internal cavity 112. For instance, in one implementation, the opening 116 can extend between the top side, the bottom side, the first lateral side, and the second lateral side of the diversion member. In other examples, the opening 116 can be defined by only the bottom side of the diversion member. In such examples, the penis can extend through the opening 116 in the wall 114 defining the bottom side, and into the internal cavity 112 of the diversion member 110.

[0104] In one implementation in which the opening 116 is in the bottom side of the diversion member 110, the diversion member 110 can include a slit that extends proximally from the opening 116 towards the proximal-most end of the diversion member 110. As described in further detail below, the slit can help to independently move portions of the bottom side relative to each other to adjust a size of the opening 116 in the bottom side of the diversion member 110, which can help to better accommodate penises of various sizes.

[0105] In some examples in which the opening 116 is in the bottom side of the diversion member 110, the proximal end of the internal cavity 112 can be closed across the entire width of the diversion member 110. This can help to mitigate urine leaking out the proximal end of the internal cavity 112. In one example implementation, the top side can be directly coupled to the bottom side of the diversion member 110. In another example implementation described below with respect to Figures 11A-11G, the bottom side can be coupled to the top side by a proximal wall. The proximal wall can provide slack between the top side and the bottom side, which can help to facilitate coupling the diversion member 110 to the user as described in further detail below. Additionally, as described below, the proximal wall can be formed from a material that is breathable and hydrophobic to mitigate leakage while allowing for ventilation between the internal cavity 112 and an environment that is external to the internal cavity 112.

[0106] In other examples in which the opening 116 is in the bottom side, the diversion member 110 can include a secondary opening 117 at the proximal end of the internal cavity 112. As such, the secondary opening 117 can have a center axis that is transverse to a center axis of the opening 116. The secondary opening 117 can provide a passage for airflow between the internal cavity 112 and the environment external to the internal cavity 112. This can help to reduce a risk of vacuum lock between the wall(s) 114 of the diversion member 110 and / orhelp to ventilate the internal cavity 112 and reduce a moisture content within the internal cavity 112.

[0107] In some implementations, the secondary opening 117 can extend across an entire width of the diversion member 110 (e.g., a width between a first lateral side and a second lateral side of the diversion member 110). This can enhance air flow through the secondary opening 117 and / or reduce a cost of manufacture compared to other implementations in which the secondary opening 117 has a reduced size.

[0108] In other implementation, the secondary opening 117 can extend across only a first portion of the width of the diversion member 110, and a second portion of the width of the diversion member 110 can be sealed. For instance, in one example, the diversion member 110 can include a plurality of proximal seams (e.g., direct couplings between the top side and the bottom side) and / or a plurality of proximal walls (e.g., which each extend between the top side and the bottom side) on opposing sides of the secondary opening 117 at the proximal end of the internal cavity, which can help to mitigate leakage of urine out the secondary opening at the proximal end. Each of the proximal seams and / or each of the proximal walls can extend inwardly from a respective lateral side of the diversion member 110 towards the secondary opening 117 at a middle portion of the diversion member 110. In this arrangement, the proximal seams and / or the proximal walls can assist in arranging the proximal end with the secondary opening 117 extending across less than an entire width of the diversion member 110, thereby reducing a size of the secondary opening 117 relative to some implementations that omit the seams.

[0109] As shown in Figure 1, the urine diversion device 100 also includes an outlet 118 in fluid communication with the internal cavity 112 of the diversion member 110. More particularly, the outlet 118 is configured to egress urine from the internal cavity 112 of the diversion member 110 (e.g., to a waste collection reservoir as shown in Figure 2). In one example, the outlet 118 can include a port 120 that is coupled to one or more of the wall(s) 114 of the diversion member 110 at a distal aperture in the diversion member 110. The port 120 can provide an interface for coupling the diversion member 110 and a drain tube.

[0110] In some implementations, the port 120 can be directly coupled to the diversion member 110 (e.g., by radiofrequency (RF) heat sealing and / or RF welding). This can help to reduce a cost of manufacture and / or reduce a quantity of coupling points between components of the outlet 118 in some examples.

[0111] In other implementations, the port 120 can be coupled to the diversion member 110 by a port tube 122. The port tube 122 can assist in spacing a point of connection between the port 120 and a drain tube farther away from the patient. This can help to improve handling by medical practitioners as the port tube 122 can provide for greater flexibility and range of movement of the port 120 while coupling the port 120 to the drain tube and / or decoupling the port 120 from the drain tube. Additionally, the port tube 122 can help to reduce a risk that a medical practitioner will inadvertently decouple the urine diversion device from the user when the medical practitioner manipulates the location and / or orientation of the port 120 to couple the port 120 with the drain tube.

[0112] In some examples, the outlet 118 can be at a distalmost end of the diversion member 110. For example, the walls 114 of the diversion member 110 can be formed from a plurality of sheets of material, and the port 120 or the port tube 122 can be coupled to the distalmost end of the diversion member 110 at a seam between the sheets of material (e.g., the port 120 can be coupled to the diversion member 110 by RF welding and / or RF heat sealing of the sheets around the port 120 or the port tube 122). In this example, the distal aperture of the diversion member 110 can be defined by a discontinuity in the seam between the sheets of material. By locating the outlet 118 at the distalmost end of the diversion member 110, pooling of urine in the diversion member 110 can be reduced (or minimized) relative to locating the outlet at more proximal locations.

[0113] In other examples, the outlet 118 can be positioned proximal of the distalmost end of the diversion member 110. For instance, the distal aperture of the diversion member the port 120 or the port tube 122 can be coupled to the distal opening in one wall 114 of the diversion member 110. This may be beneficial in implementations in which the diversion member 110 is configured to retain a volume of urine at the distalmost end of the diversion member 110. In one implementation, the port 120 can be coupled to a bottom wall of the diversion member 110 at the distal aperture formed in the bottom wall. This can help to facilitate draining and suctioning liquid from the diversion member. In another implementation, the port 120 can be coupled to a top wall of the diversion member 110 at the distal aperture formed in the top wall. Positioning the distal aperture and the port 120 at the top wall can make the port 120 more easily accessible than positioning the port 120 at the bottom wall.

[0114] In some implementations, the port 120 of the outlet 118 have a generally linear shape that can egress urine in a direction that is generally parallel to a longitudinal axis of thediversion member 110 (e.g., when the diversion member 110 is supported by a flat surface). For instance, the port 120 can be in the form a substantially straight tube. This can help to enhance egress of urine through the port 120 relative to alternative implementations in which the port 120 includes a bend.

[0115] In other implementations, the port 120 of the outlet 118 can have a non-linear shape. For instance, the port 120 can include a bend that can provide for directing the urine through one wall 114 of the diversion member 110 (e.g., a top wall) to the direction that is generally parallel to the longitudinal axis (and away from the user). In one example, the port 120 can include a bend that orients an outtake of the port 120 in the distal direction. This can help to direct the drain tube in the distal direction away from the user. In another example, the port 120 can include a bend that orients the outtake of the port 120 in the proximal direction. In instances in which a vacuum device and / or a waste collection reservoir are at a location that is proximal to the port 120, this can help to mitigate bending a drain tube coupling the port 120 to the vacuum device and / or a waste collection reservoir. In other examples, the port 120 can be oriented in other directions (e.g., transverse to a longitudinal axis of the diversion member 110).

[0116] In some examples, the port 120 can be fixedly coupled to the diversion member 110 such that the port 120 is not rotatable relative to the diversion member 110. This can simplify a manufacturing process and / or reduce a cost of manufacture. In such examples, the port 120 can have a single configuration and orientation relative to the diversion member 110.

[0117] In other examples, the port 120 can be rotatably coupled to the diversion member 110 such that port 120 can rotate about an axis relative to the diversion member 110. For instance, the port 120 can include a joint that is configured to allow the port 120 to rotate about the axis. In this arrangement, rotation of the port 120 can help to inhibit twisting or kinking of the diversion member 110 and / or the drain tube when the drain tube and / or the diversion member 110 are moved relative to each other. As a result, the port 120, which is rotatable, can help to mitigate blockage of fluid flow from the diversion member 110 to the port 120 and the drain tube.

[0118] In some implementations, the port 120 is freely rotatable by more than 360 degrees relative to the diversion member 110. This can help mitigate twisting and kinking in all rotational positions of the port 120 relative to the diversion member 110. However, in other implementations, the port 120 can be rotatable by less than 360 degrees relative to the diversionmember 110. This may help to constrain the drain tube to a particular range of positions relative to the diversion member 110, which may beneficially help to maintain the drain tube at a position extending away from the user.

[0119] In one example, the port 120 can include a thread for threadably coupling with the drain tube. In another example, the port 120 can include a hose barb and / or a Luer lock for coupling with the drain tube. In another example, the port 120 can include a tapered end portion for coupling with the drain tube (e.g., a distal end of the port 120 can have an outer diameter that decreases along a distal direction). Given that drain tubes may have different sizes (e.g., depending on the make and / or model of the vacuum device), the tapered end portion of the port 120 can help to more universally couple the port 120 to a plurality of differently sized drain tubes.

[0120] As shown in Figure 1, the urine diversion device 100 also includes one or more attachment members 124. The attachment member(s) 124 are configured to couple the diversion member 110 to the user. As examples, the attachment member(s) 124 can include at least one coupling element selected from a group consisting of: an adhesive, a waist strap, a leg strap, a hook-and-loop material (e.g., VELCRO), and a clip. The attachment member(s) 124 can be coupled to the diversion member 110 at a proximal portion of the diversion member 110. This can help to couple the diversion member 110 to the user at a position that allows the penis of the user to extend through the opening 116.

[0121] In some examples, the attachment member(s) 124 can be fixedly coupled to the diversion member 110 such that the attachment member(s) 124 is not rotatable relative to the diversion member 110. This can simplify a manufacturing process and / or reduce a cost of manufacture. In other examples, as described in further detail below with respect to Figures 11A-11G, the attachment member(s) 124 can be rotatably coupled to the diversion member 110 such that the diversion member 110 can rotate relative to the attachment member(s) 124 and the body of the user.

[0122] In one implementation in which the attachment member(s) 124 include an adhesive, the adhesive can be disposed on the exterior surface of the wall 114 that defines the bottom side of the diversion member 110. For instance, in an example, the adhesive can be disposed around the opening 116 in the bottom side of the diversion member 110. This can help to increase a surface area of contact between the adhesive and the skin of the user around a base of the penis while the penis extends through the opening 116. In another example, theadhesive can extend around less than an entirety of a circumference of the opening 116 in the bottom side of the diversion member 110. This can provide for omitting the adhesive at locations that may contact relatively sensitive areas on the skin of the user.

[0123] In some implementations, the attachment member(s) 124 can include a first attachment member 124 for coupling the bottom side of the diversion member 110 to the user, and a second attachment member 124 for coupling the top side of the diversion member 110 to the user. Providing a plurality of attachment members 124 can help to improve coupling the diversion member 110 to the user relative to implementations that include a single attachment member 124.

[0124] In examples in which the attachment member(s) 124 include an adhesive 126, the attachment member(s) 124 can additionally include a release liner 128. The release liner 128 covers and the adhesive 126 prior to coupling the attachment member(s) 124 to the user, and then the release liner 128 can be removed to expose the adhesive 126 to expose the adhesive 126 and couple the attachment member(s) 124 to the skin of the user.

[0125] In some examples, the urine diversion device 100 can include a spacer 130 in the internal cavity 112. As an example, the spacer 130 can help to inhibit (or prevent) an occurrence of a vacuum lock condition due to a vacuum pressure applied by a vacuum device. The spacer 130 can additionally or alternatively be configured to maintain a penis in an elevated position above the bottom wall of the diversion member 110.

[0126] In one example, the spacer 130 can be formed of an open-cell foam material configured to allow the urine to flow through the spacer 130 in a direction from the proximal end to the distal end. In another example, the spacer 130 can be made from other materials such as, for instance, a closed foam material and / or a batting material. However, an open-cell foam material can be particularly beneficial in that an open-cell foam material can allow the urine to flow both through and around the spacer 130. Whereas, other materials may limit and / or prevent the urine from flowing through the spacer 130. In some implementations, the open-cell foam material of the spacer 130 can allow the urine in the internal cavity 112 to flow to the outlet 118 even when the spacer 130 is compressed.

[0127] In one implementation, for instance, the spacer 130 can include a thermally reticulated 45 ppi polyether polyurethane foam (PUR). Additionally, for instance, the spacer 130 can have (i) a pore size (visual) of approximately 40 pores per inch (ppi) to approximately 50 ppi, (ii) a density of approximately 1.3 pounds per cubic foot (lbs / ft3) to approximately 1.6lbs / ft3, (iii) a tensile strength of at least approximately 10.0 pounds per square inch (psi), (iv) an elongation of 100 percent, (v) a tear of at least approximately 2.5 pounds per inch (Ibs / in), (vi) a compression load deflection at 25% R (CLD 25%R(2”x2”xl”)) of at least approximately 0.35 psi, (vii) a CLD 65%R(2”x2”xl”) of at least approximately 0.43 psi, and / or (viii) a maximum compression set of approximately 15%.

[0128] In another example, for instance, the spacer 130 can include a plurality of gas filled pockets separated by gaps, which allow the urine to flow through and around the spacer 130. For example, the pockets can be similar to bubble wrap (e.g., made from (e.g., polyethylene pockets filled with air). A quantity, a size, and / or a density of the pockets can be arranged to allow for urine flow to the outlet 118 while inhibiting a vacuum lock condition when a vacuum pressure is applied to the urine diversion device 100. In a further example, the spacer 130 can be constructed with a plurality of channels to allow the urine to flow to the outlet 118 while also allowing for air to flow, alleviating a vacuum lock condition. In one implementation, the spacer 130 can be made from a polymer material and molded, for example, by an injection molding or thermoformed molding process. Other examples are also possible.

[0129] In some examples, the diversion member 110 can be made from a flexible material such as, for instance, silicone, rubber, latex, a polyurethane film, and / or a thermoplastic. In such examples, the spacer 130 can also beneficially assist in providing support to the urine diversion device 100 to, for instance, inhibit (or prevent) twisting of the diversion member 110 and / or improve handling of the urine diversion device 100. In some implementations, the spacer 130 can extend for least fifty percent of the length of the internal cavity 112 (e.g., between the proximal end and the distal end). This can allow the spacer 130 to help to support the diversion member 110 over a relatively large portion of the urine diversion device 100. However, in other examples, the spacer 130 can extend over a smaller portion of the internal cavity 112.

[0130] In some examples, the diversion member 110 can also include one or more layers of material that can help to improve comfort and / or assist in diverting urine away from the penis of the user. For instance, the diversion member 110 can additionally include a permeable layer and / or a wicking layer. In one example arrangement, the wicking layer can be positioned between the permeable layer and the bottom side of the diversion member 110.

[0131] In this arrangement, the permeable layer can help to maintain the penis on a relatively dry surface, which in turn improves sanitary conditions, reduces the risk of infection,and / or improves user comfort. As examples, the permeable layer can be made from a porous material, which may be hydrophilic or hydrophobic. As such, the permeable layer can direct urine away from the penis and towards the bottom side of the diversion member 110. In one implementation, due to the hydrophobicity of the permeable layer, the permeable layer can repel urine and / or moisture in a direction away from the penis toward the wicking layer.

[0132] As one example, the permeable layer can be made from a polymer spunbond material. Additionally, in an example, the permeable layer can be formed by treating a material (e.g., a natural fiber material and / or a synthetic fiber material) with a surfactant, which lowers a surface tension of fluids (e.g., the urine and / or sweat) and forms a moisture transfer channel through the permeable layer to facilitate transferring the fluids or moisture from a side of the permeable layer that engages the penis to a side of the permeable layer that faces the wicking layer (i.e., in a direction from the top side toward the bottom side).

[0133] The wicking layer can assist in pulling the urine, moisture, or sweat through the permeable layer toward the bottom side of the diversion member 110. For example, the wicking layer can be made from a material that is configured to provide for capillary action to move the urine, moisture, or sweat from a side of the wicking layer facing the permeable layer to a side of the wicking layer facing the bottom side of the diversion member 110 (i.e., in the direction from the top side toward the bottom side). In particular, for example, the wicking layer can be configured to provide for transverse wicking of the urine, moisture, and / or sweat from the permeable layer to the bottom. As one example, the wicking layer can be made from a mechanically absorbent polyester mesh material.

[0134] Referring now to Figure 2, a simplified diagram of a system 232 for diverting urine is depicted according to an example. As shown in Figure 2, the system 232 includes the urine diversion device 100 described above (and any of the urine diversion devices described herein). Additionally, as shown in Figure 2, the system 232 includes a drain tube 234, a waste collection reservoir 236, and a vacuum device 238.

[0135] A first end 234A of the drain tube 234 is coupled to the outlet 118 of the diversion member 110. For example, the drain tube 234 can include a thread, a Luer lock, and / or other feature for coupling the drain tube 234 to the outlet 118. Within examples, the drain tube 234 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 234 away from the user’s body (e.g.,off the side of a bed) to reduce (or prevent) the drain tube 234 from accidental pulling and leakage resulting from such pulling.

[0136] The waste collection reservoir 236 is coupled to a second end 234B of the drain tube 234 to receive the urine from the drain tube 234. In one example, the waste collection reservoir 236 can be a leg bag, a drainage bag, a rigid canister, or other container. In another example, the waste collection reservoir 236 can include a hanger and / or another structure for coupling the waste collection reservoir 236 to a patient support surface 240 (e.g., a bed and / or a wheelchair) used by the patient.

[0137] In some examples, the waste collection reservoir 236 can be a sealed container. This can, for example, reduce (or minimize) a risk of spillage and / or contamination. In some examples, the waste collection reservoir 236 can be disposable. In other examples, the waste collection reservoir 236 can be reusable. For instance, the waste collection reservoir 236 can be configured to be sterilized after a use and reused.

[0138] The vacuum device 238 can apply a vacuum pressure to the drain tube 234 to assist in directing the urine from the outlet 118 to the waste collection reservoir 236. For instance, the vacuum device 238 can include an air pump or other vacuum source, which is coupled to the waste collection reservoir 236 by an air tube 242. In one example, the air tube 242 can also be made of a flexible material.

[0139] In some examples, the vacuum device 238 can be a wall vacuum integrated into a room of a medical facility. In other examples, the vacuum device 238 can be integrated with the patient support surface 240. For instance, the vacuum device 238 can be integrated with a bed in a medical facility. The vacuum device 238 can then be operated to apply the vacuum pressure at the 118 130 (e.g., via the air tube 242, the waste collection reservoir 236, and the drain tube 234).

[0140] Within some examples, the system 232 can also include an occlusion clip for selectively controlling the flow of urine in the drain tube 234. For instance, the occlusion clip can provide for stopping the flow of urine in the drain tube 234 to facilitate changing and / or emptying the waste collection reservoir 236.

[0141] Referring now to Figures 3A-3D, a urine diversion device 300 according to an example implementation of the urine diversion device 100 described above. More specifically, Figure 3A is an exploded view of the urine diversion device 300, Figure 3B is a perspective view of the urine diversion device 300, Figure 3C is a top view of the urine diversion device300, Figure 3D is a side view of the urine diversion device 300 with a bottom side and a top side of the diversion member 110 in an open arrangement at the proximal end, and Figure 3E depicts a cross-sectional view of the urine diversion device 300 taken through a line 344 in Figure 3D, according to the example.

[0142] As shown in Figures 3A-3E, the urine diversion device 300 includes the diversion member 110 that is suitable to direct urine toward the outlet 118. The diversion member 110 extends from a proximal end 110A to a distal end HOB. As shown in Figures 3B- 3C, the diversion member 110 has a width that tapers inwardly along a longitudinal axis 346 from the proximal end 110A to the distal end HOB. This can help to direct the urine received in the internal cavity 112 inwardly toward the outlet 118 at the distal end 110B. As described above, the width of the diversion member 110 can be non-tapered between the proximal end 110A and the distal end 110B in other examples.

[0143] Additionally, as shown in Figures 3A-3E, the diversion member 110 includes a top wall 314A and a bottom wall 314B that extend between the proximal end 110A and the distal end 110B. In this example, the top wall 314A is at the top side of the diversion member 110 and the bottom wall 314B is at the bottom side of the diversion member 110. Additionally, the top wall 314A is coupled to the bottom wall 314B at a first lateral side 348A and a second lateral side 348B of the diversion member 110. In the example shown in Figures 3A-3E, the diversion member 110 includes a first lateral seam at the first lateral side 348A and a second lateral seam at the second lateral side 348B. However, in other examples, the diversion member 110 can include one or more of the walls 114 at the first lateral side 348A and / or the second lateral side 348B in other examples.

[0144] As shown in Figures 3A and 3C, the diversion member 110 can include the opening 116 extending through the bottom wall 314B at the bottom side of the diversion member 110. The opening 116 provides access to an internal cavity 112 of the diversion member 110. Also shown in Figures 3A and 3C, a slit 350 can extend proximally from the opening 116 towards the proximal end 110A of the diversion member 110. The slit 350 can help to independently move portions of the bottom side relative to each other to adjust a size of the opening 116 in the bottom side of the diversion member 110, which can help to better accommodate penises of various sizes.

[0145] As shown in Figure 3D, in this example, the diversion member 110 includes the secondary opening 117 at the proximal end of the internal cavity 112. The secondaryopening 117 can have a center axis that is transverse to a center axis of the opening 116. The secondary opening 117 can provide a passage for airflow between the internal cavity 112 and the environment external to the internal cavity 112. This can help to reduce a risk of vacuum lock between the wall(s) 114 of the diversion member 110 and / or help to ventilate the internal cavity 112 and reduce a moisture content within the internal cavity 112.

[0146] Although the opening 116 is in the bottom side and the diversion member 110 includes the secondary opening 117 at the proximal end 110A in Figures 3A-3E, the opening 116 can instead be at the proximal end 110A and / or the diversion member 110 can omit the secondary opening 117 in other examples.

[0147] As described above, in some examples, the diversion member 110 can also include one or more layers of material that can help to improve comfort and / or assist in diverting urine away from the penis of the user. In the example shown in Figures 3 A-3E, the diversion member 110 includes a permeable layer 352 A and a wi eking layer 352B. As shown in Figure 3E, the wi eking layer 352B can be positioned between the permeable layer 352A and the bottom side of the diversion member 110 (e.g., between the permeable layer 352A and the bottom wall 314B). In this arrangement, the permeable layer 352A can help to maintain the penis on a relatively dry surface, which in turn improves sanitary conditions, reduces the risk of infection, and / or improves user comfort.

[0148] Additionally, in this arrangement, the internal cavity 112 can include a first chamber 354 A and a second chamber 354B with the permeable layer 352 A and / or the wi eking layer 352B separating the first chamber 354 A from the second chamber 354B. The permeable layer 352A and / or the wi eking layer 352B can be coupled to the bottom side (e.g., the bottom wall 314B) such that permeable layer 352A and / or the wicking layer 352B inhibit access to the second chamber 354B from outside of the first chamber 354 A. Thus, when the user inserts a penis through the opening 116, the penis is received in the first chamber 354A of the internal cavity 112.

[0149] With the user’s penis extending through the opening 116, urine can be initially received in the first chamber 354A of the diversion member 110. The received urine can be directed from the first chamber 354 A to the second chamber 354B so as to reduce (or minimize) contact between the user and the urine. This can beneficially improve user comfort, and / or improve hygiene and sanitary conditions for the user.

[0150] To direct the urine from the first chamber 354A to the second chamber 354B, the first chamber 354A is in communication (i.e., fluid communication) with the second chamber 354B. For example, as described above, the permeable layer 352 A can be made from a porous material, which can direct urine received in the first chamber 354 A toward the second chamber 354B. Additionally, as described above, the wi eking layer 352B can assist in pulling the urine, moisture, or sweat through the permeable layer 352A toward the second chamber 354B.

[0151] As shown in Figure 3C, the permeable layer 352A and / or the wicking layer 352B can be coupled to the bottom side (e.g., the bottom wall 314B) at a location proximal to the opening 116 in the bottom side (e.g., the bottom wall 314B). For instance, the permeable layer 352A and / or the wicking layer 352B can be coupled to the bottom wall 314B at a seam 356 shown in Figure 3C.

[0152] Additionally, as shown in Figures 3A and 3C, the permeable layer 352A and / or the wicking layer 352B can extend between the proximal end 110A of the diversion member 110 and the distal end HOB of the diversion member 110 (e.g., a proximal end of the bottom wall 314B and a distal end of the bottom wall 314B). In this arrangement, the permeable layer 352A and / or the wicking layer 352B can extend around the opening 116 in the bottom wall 314B of the diversion member 110. As a result, the permeable layer 352A and / or the wicking layer 352B can extend around the penis extending through the opening 116, which can help to inhibit leakage of urine through the opening 116 and / or the secondary opening 117.

[0153] Additionally, to assist in directing the urine in the second chamber 354B to the outlet 118 at the distal end HOB, the urine diversion device 100 can include the spacer 130 in the second chamber 354B. The spacer 130 can, for example, help to separate the bottom wall 314B from the permeable layer 352A and / or the wicking layer 352B. This can help to inhibit (or prevent) an occlusion of the second chamber 354B, which may negatively impact egress of the urine from the urine diversion device 100. Additionally, for example, the spacer 130 can help to inhibit (or prevent) an occurrence of a vacuum lock condition due to the vacuum pressure applied by a vacuum device (such as, e.g., the vacuum device 238 depicted in Figure 2).

[0154] As noted above, the diversion member 110 can be made from a flexible material such as, for instance, silicone, rubber, latex, and / or a thermoplastic. The spacer 130 can also beneficially assist in providing support to the urine diversion device 100 to, forinstance, inhibit (or prevent) twisting of the diversion member 110 and / or improve handling of the urine diversion device 100.

[0155] In Figures 3A and 3D, the spacer 130 extends from the proximal end 110A to the distal end HOB. This can allow the spacer 130 to help to support the diversion member 110 over a relatively large portion of the urine diversion device 100. However, in other examples, the spacer 130 can extend over a smaller portion of the second chamber 354B.

[0156] As described above, the diversion member 110 is suitable to (i) direct urine from the first chamber 354 A to the second chamber 354B and (ii) direct the urine in the second chamber 354B distally toward the outlet 118 (e.g., through and / or around the spacer 130). The outlet 118 is configured to egress the urine from internal cavity 112 of the diversion member 110. In the example shown in Figures 3A-3E, the outlet 118 includes the port 120 and a port tube 122, which couples the port 120 to the diversion member 110. The port tube 122 can assist in spacing the port 120 away from the patient, which can help to improve handling by medical practitioners as the port tube 122 can provide for greater flexibility and range of movement of the port 120 while coupling the port 120 to the drain tube and / or decoupling the port 120 from the drain tube. Additionally, the port tube 122 can help to reduce a risk that a medical practitioner will inadvertently decouple the urine diversion device from the user when the medical practitioner manipulates the location and / or orientation of the port 120 to couple the port 120 with the drain tube.

[0157] In this example, the port 120 includes a tapered end portion, which can help to more universally couple the port 120 to a plurality of differently sized drain tubes 234. However, in other examples, the port 120 can include a thread for threadably coupling with the drain tube 234. In another example, the port 120 can include a hose barb and / or a Luer lock for coupling with the drain tube 234.

[0158] In Figures 3A-3E, the outlet 118 is at a distalmost point of the diversion member 110. As noted above, locating the outlet 118 near or at the distal end HOB, pooling of urine at the distal end 110B can be reduced (or minimized). However, in other examples, the outlet 118 can be at other locations on the diversion member 110.

[0159] As shown in Figures 3A-3E, the urine diversion device 300 further includes one or more attachment members 324A-324B that are suitable to secure the urine diversion device 100 to a user. In particular, in Figures 3A-3E, the urine diversion device 300 includes a first attachment member 324A and a second attachment member 324B. However, the urinediversion device 300 can include a single attachment member 324A-324B or more than two attachment members 324A-324B in other examples.

[0160] As shown in Figure 3C, the first attachment member 324A can be coupled to the bottom wall 990B of the diversion member 110. For instance, in this example, the first attachment member 324A can be an adhesive that extends along a proximal portion of the bottom wall 314B. As shown in Figure 3C, the adhesive of the first attachment member 324A can extend around the opening 116 of the diversion member 110. As such, when the urine diversion device 300 is secured to the user, the adhesive of the first attachment member 324A couples to the skin around the penis of the user. This can help to improve the coupling between the diversion member 110 and the user.

[0161] For instance, the adhesive of the first attachment member 324A can be on the outer side of the bottom wall 314B. As such, when the first attachment member 324A is secured to the user, the adhesive on the outer side of the bottom wall 314B can contact and adhere to the pelvic area of the user to assist in retaining the urine diversion device 300 in the desired position. By providing the adhesive on the outer side of the bottom wall 314B, which contacts the pelvic area of the user, the first adhesive 926A can more comfortably adhere the urine diversion device 300 to a less sensitive part of the body than a condom catheter.

[0162] In Figures 3A-3E, the opening 116 can have a generally oblong and / or a substantially elliptical shape of. Within examples, the generally oblong and / or a substantially elliptical shape of opening 116 can assist in improving securing the first attachment member 324A to the user in relatively close proximity to the penis of the user.

[0163] In Figures 3A-3E, the permeable layer 352A can be arranged in the urine diversion device 300 such that the permeable layer 352A and / or the wicking layer 352B overlap with a portion of the adhesive of the first attachment member 324A. For instance, as shown in Figure 3C, the permeable layer 352A and / or the wicking layer 352B can extend to a proximal end of the bottom wall 314B (e.g., the proximal end 110A) and around the opening 116. This can assist in inhibiting leakage of urine from the urine diversion device 300 when a user is turned (e.g., relative to a hospital bed).

[0164] As shown in Figures 3A-3D, the second attachment member 324B coupled to the top wall 314A of the diversion member 110 at the proximal end 110A. The second attachment member 324B includes an inner side for contacting a pelvic area of a user and an outer side facing away from the user when the urine diversion device 300 is secured to the user.Additionally, the second attachment member 324B includes a second adhesive to assist in securing the second attachment member 324B to the user. Specifically, the second adhesive is coupled to the inner side of the second attachment member 324B.

[0165] In some examples, the second attachment member 324B can extend proximally of a proximal-most end of the first attachment member 324A and / or the bottom wall 314B. This can assist in allowing the second attachment member 324B to be secured to the user at a location that is above a location at which the first attachment member 324A is secured to the user.

[0166] As shown in Figure 3B, the second attachment member 324B includes a first arm 360A and a second arm 360B laterally extending from a center portion 360C. Specifically, the first arm 360A and the second arm 360B laterally extend from the center portion 360C. In this arrangement, when the second attachment member 324B is secured to the user via the second adhesive, the center portion 360C can be located at a middle area of the user’s pelvic area and / or abdomen so that the first arm 360A and the second arm 360B extend to areas adjacent to the middle area of the user’s pelvic area and / or abdomen. As noted above, this can help to reduce (or minimize) contact between the second adhesive and the user’s hair, and / or improve stability of the urine diversion device 300 secured to the user.

[0167] In one implementation, a surface of the second adhesive which faces the user can have an active adhesive portion that is configured to adhere to the user. A portion of the second adhesive which faces the user can have an inactive adhesive portion that does not adhere to the user, such as the center portion 360C between the first arm 360 A and the second arm 360B. This can further assist in reducing (or minimizing) an extent to which the second adhesive adheres to the hair of the user at the middle area of the user’s pelvic area and / or abdomen. In another implementation, the active adhesive portion of the second adhesive can include at least a portion (or an entirety) of the first arm 360A, the second arm 360B, and / or the center portion 360C of the second adhesive, such that the second adhesive can adhere to the user at the first arm 360A, the second arm 360B, and / or the center portion 360C of the second adhesive.

[0168] Referring now to Figures 4A-4B, a process for using the urine diversion device 300 is depicted according to an example embodiment. To secure the urine diversion device 300 to a user, the portions of the first attachment member 324A and the bottom wall 314B on opposing sides of the opening 116 are moved away from each other to expand the size of theopening 116 in the diversion member 110. Next, the first attachment member 324A is positioned on a pelvic area 462 of the user such that the penis of the user extends through the opening 116. After the penis is received in the opening 116, the portions of the first attachment member 324A and / or the bottom wall 314B can be moved toward each other to reduce the size of the opening 116, and the first attachment member 324A can be coupled to the pelvic area 462 of the user by the first adhesive. In this way, the first attachment member 324A and / or the bottom wall 314B can provide for dynamically adjusting the size of the opening 116 to accommodate the specific size and / or shape of the penis, as described above.

[0169] Figure 4A depicts the first attachment member 324A secured to the pelvic area 462 of the user with the penis of the user extending through the opening 116 in the first attachment member 324A and the bottom wall 314B. In some examples, inserting the penis through the opening 116 can also result in the penis extending into the first chamber 354A of the diversion member 110. In other examples, the penis may be outside of the first chamber 354A at this stage in the process.

[0170] As shown in Figure 4B, after the penis is inserted into the first chamber 354A, the second attachment member 324B is secured to the pelvic area 462 of the user by the second adhesive of the second attachment member 324B. Additionally, as shown in Figure 4B, when the urine diversion device 300 secured to the user, a gap 464 can be formed between the first attachment member 324A and the second attachment member 324B on opposing sides of the urine diversion device 300. The gaps 464 can beneficially allow for air flow through the secondary opening 117 and into the first chamber 354A. This air flow can beneficially help to, for example, maintain sanitary conditions and / or improve user comfort. Additionally, for example, the airflow provided by the gaps can help to reduce (or minimize) a risk of a vacuum lock condition occurring.

[0171] With the urine diversion device 300 secured to the user as shown in Figure 4B, the user’s penis is received in the first chamber 354A and above the second chamber 354B. When the user urinates, the urine is initially received in the first chamber 354A of the internal cavity 112. The urine is then directed from the first chamber 354A to the second chamber 354B via the permeable layer 352A and / or the wicking layer 352B. For instance, the urine may initially contact the permeable layer 352A, which supports the penis in the first chamber 354A. The urine can pass through the permeable layer 352 A to the wicking layer 352B, which can provide capillary action to move the urine from the permeable layer 352 A to the second chamber 354B.

[0172] As the first chamber 354A is separated from the second chamber 354B by the permeable layer 352A and / or the wicking layer 352B, contact between the user’s penis and the urine is reduced or minimized. Additionally, the spacer 130 in the second chamber 354B can assist in maintaining the penis at an elevated position relative to the urine in the second chamber 354B and, thus, can help to further reduce or minimize contact between the user’s penis and the urine. By reducing or minimizing contact between the user’s penis and the urine, the urine diversion device 300 improves sanitary conditions, reduces the risk of infection, and / or improves user comfort.

[0173] The urine in the second chamber 354B can be directed distally toward the outlet 118. At the outlet 118, the urine can be egressed from the diversion member 110, for example, under a vacuum pressure applied by a vacuum device (e.g., the vacuum device 238) and a drain tube 234 coupled to the outlet 118 of the diversion member 110. As described above, this flow of the urine through the diversion member 110 can be assisted by the hydrophobicity of the permeable layer 352A, the capillary action of the wicking layer 352B, gravity, and / or a vacuum pressure applied by a vacuum device (e.g., the vacuum device 238) at the outlet 118 of the diversion member 110.

[0174] Referring now to Figures 5A-5B, the spacer 130 is shown according to one example. Figure 5A depicts a top side of the spacer 130 and Figure 5B depicts a bottom side of the spacer 130 according to the example.

[0175] In Figures 5A-5B, the spacer 130 has a proximal-spacer end 530A, a distal- spacer end 530B, a first lateral side 530C, and a second lateral side 530D. The spacer 130 also includes a first major surface 530E extending between the proximal-spacer end 530A, the distal-spacer end 530B, the first lateral side 530C, and the second lateral side 530D. Opposing the first major surface 530E, the spacer 130 includes a second major surface 53 OF extending between the proximal-spacer end 530A, the distal-spacer end 530B, the first lateral side 530C, and the second lateral side 530D.

[0176] The spacer 130 shown in Figures 5A-5B can be positioned in the second chamber 354B as described above and as shown, for instance, in Figure 3E. When the spacer 130 is in the second chamber 354B, the distal-spacer end 530B can be adjacent to the outlet 118 and / or the distal end HOB of the diversion member 110, the proximal-spacer end 530A can nearer the proximal end 110A of the diversion member 110 than the distal-spacer end 530B, the first lateral side 530C of the spacer 130 can be adjacent to the first lateral side 348Aof the diversion member 110, and the second lateral side 530D of the spacer 130 can be adjacent to the second lateral side 348B of the diversion member 110. In this arrangement, the first major surface 530E can face the permeable layer 352A, the wicking layer 352B, and / or the top wall 314A of the diversion member, and the second major surface 530F can face the bottom wall 314B of the diversion member 110.

[0177] In Figures 5A-5B, the spacer 130 has a width 566 that extends in a dimension between the first lateral side 530C and the second lateral side 530D. As shown in Figures 5A- 5B, the width 566 of the spacer 130 can taper inwardly along a direction extending from the proximal-spacer end 530A toward the distal-spacer end 530B. As a result, the width 566 at the proximal-spacer end 530A can be greater than the width 566 at the distal-spacer end 530B. This can be beneficial in implementations in which the first lateral side 348A and the second lateral side 348B of the diversion member 110 have a similar inwardly tapered shape. However, the spacer 130 can have other shapes in other examples.

[0178] In Figures 5A-5B, the first major surface 530E and the second major surface 530F extend continuously between the proximal-spacer end 530A, the distal-spacer end 530B, the first lateral side 530C, and the second lateral side 530D such that there are no discontinuities along the first major surface 530E and the second major surface 530F. However, in some implementations, the spacer 130 may inhibit the bendability of the diversion member 110. For example, in one implementation, the spacer 130 can be formed from an open-cell foam. The spacer 130 formed from the open-cell foam may be easier to handle and / or retain less urine than other implementations (e.g., in which the spacer 130 is formed from a batting material), but may be less flexible than the other implementations.

[0179] To help improve the flexibility of the spacer 130, the spacer 130 can include one or more preferential separation regions in at least one of the first major surface 530E or the second major surface 530F. As an example, Figures 6A-6B depict the spacer 130 shown in Figure 5 with one or more preferential separation regions 668 to help improve the flexibility of the spacer 130. In particular, Figure 6A depicts a top side of the spacer 130 and Figure 6B depicts a bottom side of the spacer 130 according to the example.

[0180] In Figures 6A-6B, the spacer 130 has the proximal-spacer end 530A, the distal- spacer end 530B, the first lateral side 530C, and the second lateral side 530D. The spacer 130 also includes the first major surface 530E extending between the proximal-spacer end 530A, the distal-spacer end 530B, the first lateral side 530C, and the second lateral side 530D.Opposing the first major surface 530E, the spacer 130 includes the second major surface 53 OF extending between the proximal-spacer end 530A, the distal-spacer end 530B, the first lateral side 530C, and the second lateral side 530D.

[0181] When the spacer 130 is positioned in the second chamber 354B, the distal- spacer end 53 OB can be adjacent to the outlet 118 and / or the distal end HOB of the diversion member 110, the proximal-spacer end 530A can nearer the proximal end 110A of the diversion member 110 than the distal-spacer end 530B, the first lateral side 530C of the spacer 130 can be adjacent to the first lateral side 348 A of the diversion member 110, and the second lateral side 530D of the spacer 130 can be adjacent to the second lateral side 348B of the diversion member 110. In this arrangement, the first major surface 530E can face the permeable layer 352A, the wicking layer 352B, and / or the top wall 314A of the diversion member, and the second major surface 530F can face the bottom wall 314B of the diversion member 110.

[0182] In Figures 6A-6B, the spacer 130 has the width 566 that extends in the dimension between the first lateral side 530C and the second lateral side 530D. As shown in Figures 6A-6B, the width 566 of the spacer 130 can taper inwardly along a direction extending from the proximal-spacer end 530A toward the distal-spacer end 530B. As a result, the width 566 at the proximal-spacer end 530A can be greater than the width 566 at the distal-spacer end 530B. This can be beneficial in implementations in which the first lateral side 348A and the second lateral side 348B of the diversion member 110 have a similar inwardly tapered shape. However, the spacer 130 can have other shapes in other examples.

[0183] As noted above, the spacer 130 shown in Figures 6A-6B includes the one or more preferential separation regions 668 in at least one of the first major surface 530E or the second major surface 530F. The preferential separation region(s) 668 can provide for separation between respective portions of the first major surface 530E and / or separate between respective portions of the second major surface 53 OF, which can help to enhance the flexibility of the spacer 130.

[0184] In an example, the preferential separation region(s) 668 can include one or more slits 670 that each extend entirely through a thickness of the spacer 130, where the thickness is defined as a dimension extending between the first major surface 530E and the second major surface 530F (e.g., perpendicular to the width 566). For instance, in the example shown in Figures 6A-6B, the one or more slits 670 include a plurality of slits 670 that are offset from each other along a length of the spacer 130, where the length is defined as a dimensionextending between the proximal-spacer end 530A and the distal-spacer end 530B. This can help to increase the flexibility of the spacer 130 over the length of the spacer 130.

[0185] As shown in Figures 6A-6B, the slits 670 can be parallel to each other. In this arrangement, the spacer 130 can have a greater strength than other implementations in which the slits 670 are oriented in a plurality of different directions. In Figures 6A-6B, the slits 670 of extend along a dimension that is parallel to the width 566 of the spacer 130. This can help to provide for preferential flexibility along the spacer 130. In other examples, the slits 670 can be oriented in a plurality of different directions and / or along dimensions that are not parallel to the width 566 of the spacer 130.

[0186] In Figures 6A-6B, the slits 670 extend entirely through the thickness of the spacer 130 (e.g., entirely through the spacer 130 from the first major surface 530E and the second major surface 530F). However, in other examples, one or more of the slits 670 can extend partially through the thickness of the spacer 130 instead.

[0187] Additionally, in Figures 6A-6B, the slits 670 are generally elongated cuts in the spacer 130. In still other examples, the one or more preferential separation regions 668 can additionally or alternatively include one or more apertures each having a shape selected from a group consisting of: a circle, an oval, a rectangle, a triangle, a square, a hexagon, an octagon, and a non-polygonal shape. As examples, Figures 7A-7B depict the spacer 130 including apertures 770 with various shapes. More generally, the spacer 130 can include one or more of the slits 670 and / or the apertures 770 according to still other examples.

[0188] In the example shown in Figures 3A-3E, the urine diversion device 300 includes the secondary opening 117 at the proximal end of the internal cavity 112. The secondary opening 117 can provide a passage for airflow between the internal cavity 112 and the environment external to the internal cavity 112. This can help to reduce a risk of vacuum lock between the wall(s) 114 of the diversion member 110 and / or help to ventilate the internal cavity 112 and reduce a moisture content within the internal cavity 112. In Figures 3 A-3E, the secondary opening 117 extends entirely between the first lateral side 348 A, the second lateral side 348B, the top wall 314A, and the bottom wall 314B at the proximal end 110A. One drawback to a relatively large secondary opening 117 is that urine may potentially leak out of the secondary opening 117 when the urine diversion device 300 is coupled to the user and the user lays on their side.

[0189] To mitigate leakage out the proximal end 110A, the diversion member 110 can include a proximal wall extending from the proximal end of the bottom wall 314B to the top wall 314A to define a proximal-most end of the internal cavity 112. Figures 8A-8B depict a urine diversion device 800 including a proximal wall 872 according to one example. The urine diversion device 800 is substantially similar or identical to the urine diversion devices 100, 300 described above, except the diversion member 110 of the urine diversion device 800 includes the proximal wall 872 extending from the proximal end 110A of the bottom wall 314B to the top wall 314A to define a proximal-most end of the internal cavity 112.

[0190] In this example, the proximal wall 872 is coupled to the top wall 314A and the bottom wall 314B. For instance, the proximal wall 872 can be welded to the top wall 314A and the bottom wall 314B. In some examples, the proximal wall 872 can extend entirely between the first lateral side 348A and the second lateral side 348B such that there is no gap between the proximal wall 872, the first lateral side 348 A, and the second lateral side 348B. This can help to inhibit leakage of urine at the proximal end 110A.

[0191] As described above, the bottom wall 314B can include the slit 350 that extends from the opening 116 to the proximal end of the bottom wall 314B. In such examples, the proximal wall 872 can include a slit 874 partially extending from the bottom wall 314B towards the top wall 314A. The slit 874 in the proximal wall 872 can help to allow movement of the portions of the bottom wall 314B on opposing sides of the opening 116 to facilitate inserting the penis through the opening 116 and / or adhering the first attachment member 324A to the user.

[0192] Additionally, in a dimension extending between the bottom wall 314B and the top wall 314A, the proximal wall 872 can have a length that is greater than a maximum separation distance between the bottom wall 314B and the top wall 314A at the location of the proximal wall 872. This can also help to avoid overly limiting movement of the top wall 314A and / or the second attachment member 324B relative to the bottom wall 314B and / or the first attachment member 324A. In other examples, the proximal wall 872 can have a length that is less than the maximum separation distance between the bottom wall 314B and the top wall 314A such that the length of t the proximal wall 872 defines the extent by which the bottom wall 314B can be separated from the top wall 314A to the proximal end 110A.

[0193] As shown in Figure 8B, a center portion of the proximal wall 872 can extend proximally from a location on the top wall 314A and / or the bottom wall 314B at which aperiphery of the proximal wall 872 is coupled. For instance, as shown in Figure 8B, the proximal wall 872 can have a proximally extending cup shape. As shown in Figure 8A, when the urine diversion device 800 is coupled to the user, the proximal wall 872 can be folded to reduce a size occupied by the proximal wall 872.

[0194] As shown in Figures 8A-8B, the second attachment member 324B can be positioned proximally of the proximal wall 872 of the diversion member 110. This can help to extend the second attachment member 324B proximally of the proximal wall 872 to couple to the skin of the user.

[0195] In some examples, the proximal wall 872 can be formed from a material that is breathable and hydrophobic. As described above, the bottom wall 314B and the top wall 314A are formed from a liquid impervious polymer material. The proximal wall 872 formed from the material that is breathable and hydrophobic can help to provide for venting of the internal cavity 112 through the proximal wall 872 to help improve patient comfort and / or facilitate egress of moisture from the internal cavity 112 to an external environment, while mitigating leakage of urine. In one example, the proximal wall 872 can include a spun bound material having a hydrophobic finish that is configured to inhibit leakage of urine out of the proximal-most end of the internal cavity 112.

[0196] In some examples, the proximal wall 872 can be directly coupled to the bottom wall 314B. In other examples, the proximal wall 872 can be coupled to the bottom wall 314B via the permeable layer 352 A and / or the wi eking layer 352B.

[0197] Referring now to Figures 9A-9B, a urine diversion device 900 is shown according to another example. Figure 9A depicts a top view of the urine diversion device 900 and Figure 9B depicts a bottom view of the urine diversion device 900 according to the example. The urine diversion device 900 can be substantially similar or identical to the urine diversion devices 100, 300, 800 described above, except for several differences described below. One or more of the features described for the urine diversion device 900 can be combined or modified with any other set of features described herein.

[0198] As shown in Figures 9A-9B, the urine diversion device 900 includes the diversion member 110, the outlet 118, a first attachment member 924 A, and a second attachment member 924B. In Figures 3A-3E, the outlet 118 is shown including the port 120 and the port tube 122. However, as described above, the outlet 118 can omit the port tube 122. Figures 9A-9B show an example in which the outlet 118 omits the port tube 122 and the port120 is directly coupled to the distal end HOB of the diversion member 110. Omitting the port tube 122 can help to reduce a cost of manufacture.

[0199] In Figures 9A-9B, the first attachment member 924A is substantially similar to the first attachment member 324A shown in Figure 3C, except the first attachment member 924A includes an adhesive that has a different pattern than the adhesive of the first attachment member 324A shown in Figure 3C. For instance, in Figure 3C, the adhesive on the first attachment member 324A that is defined by a single continuous outer border with a continuous pattern of adhesive (e.g., without any gaps or breaks) within the continuous outer border. By contrast, as shown in Figure 9B, the first attachment member 924A has a plurality of adhesive portions 976A that are separated from each other by a plurality of gaps 976B. The gaps can help to reduce a cost of manufacture and / or reduce an extent of contact between the skin of the user and the adhesive. In this example, the adhesive portions 976A and the gaps 976B extend outwardly and slightly distally from the opening 116. This adhesive pattern can help to provide good adhesion near the scrotum.

[0200] As shown in Figures 9A-9B, the second attachment member 924B differs from the second attachment member 324B shown in Figures 3 A-3E in that the adhesive of the second attachment member 924B has a different shape and size. In particular, the adhesive of the second attachment member 924B is smaller than the adhesive of the second attachment member 324B. For instance, the second attachment member 924B and the adhesive on the second attachment member 924B can have a crescent shape. The adhesive of the second attachment member 924B can be configured to couple to the user as described above. This can help to maintain a shape of the diversion member 110 and mitigate the diversion member 110 collapsing on itself while in use.

[0201] In the example shown in Figures 9A-9B, the urine diversion device 900 omits the permeable layer 352 A and the wi eking layer 352B. Instead, the urine diversion device 900 includes a hydrophobic layer 952 in the internal cavity 112 of the diversion member 110. The hydrophobic layer 952 can help to move urine distally toward the outlet 118 without retaining the urine within the hydrophobic layer 952. As an example, the hydrophobic layer 952 can be a nylon material (e.g., a woven nylon) having a hydrophobic coating.

[0202] In Figures 9A-9B, the hydrophobic layer 952 extends entirely from the proximal end 110A of the diversion member 110 to the distal end HOB of the diversion member 110. However, in other examples, the hydrophobic layer 952 can extend over lessthan an entirety of the length of the diversion member 110. For instance, in another example, a proximal end of the hydrophobic layer 952 can be proximal of the opening 116. This can help to reduce a cost of manufacture.

[0203] In Figures 9A-9B, the spacer 130 is enclosed by the hydrophobic layer 952 (e.g., the hydrophobic layer 952 can be in the form of a pocket and the spacer 130 can be positioned in the pocket of the hydrophobic layer 952. This can help to improve aesthetics of the urine diversion device 900. Additionally or alternatively, enclosing the spacer 130 in the hydrophobic layer 952 can help to reduce an extent of the urine contact with the spacer 130, which may help to more quickly move the urine to the outlet 118. In other examples, the spacer 130 can be positioned on only one side of the hydrophobic layer 952 in a manner similar to that shown and described above with respect to the position of the spacer 130 relative to the permeable layer 352 A and the wi eking layer 352B. In still other examples, the spacer 130 can be omitted. In any case, the hydrophobic layer 952 can help to define the first chamber 354 A and the second chamber 354B in a manner similar to that described above with respect to the permeable layer 352A and the wi eking layer 352.

[0204] Referring now to Figures 10A-10B, a urine diversion device 1000 is shown according to another example. Figure 10A depicts a top view of the urine diversion device 1000 and Figure 10B depicts a bottom view of the urine diversion device 1000 according to the example.

[0205] The urine diversion device 1000 can be substantially similar or identical to the urine diversion devices 100, 300, 800, 900 described above, except for several differences described below. As shown in Figures 10A-10B, the urine diversion device 1000 includes the diversion member 110 that is suitable to direct urine to the outlet 118. The diversion member 110 extends from the proximal end 110A to the distal end HOB.

[0206] Additionally, as shown in Figures 10A-10B, the diversion member 110 includes the top wall 314A and the bottom wall 314B that extend between the proximal end 110A and the distal end HOB. Additionally, the top wall 314A is coupled to the bottom wall 314B at the first lateral side 348A and the second lateral side 348B of the diversion member 110. The diversion member 110 can include the opening 116 extending through the bottom wall 314B at the bottom side of the diversion member 110. The opening 116 provides access to the internal cavity 112 of the diversion member 110. Also shown in Figure 10B, the bottom wall 314B can include the slit 350 to independently move portions of the bottom side relativeto each other to adjust a size of the opening 116 in the bottom side of the diversion member 110, which can help to better accommodate penises of various sizes.

[0207] As shown in Figures 10A-10B, along a direction from the proximal end 110A toward the distal end HOB, a width of the diversion member 1110 (i) increases outwardly away from a center axis 346 of the diversion member 110 along a proximal portion extending from the proximal end 110A to a comer portion 1078 at the first lateral side 348 A and a corner portion 1078 at the second lateral side 348B, and (ii) decreases inwardly toward the center axis 346 from the corner portions 1078 to the distal end HOB. For instance, the width of the diversion member 110 can taper outwardly from the proximal end 110A to a corner portions 1078, and taper inwardly from the comer portions 1078 to the distal end 110B (e.g., the diversion member 110 can have a tear drop shape). In this arrangement, the diversion member 110 can be configured to direct urine along one of the first lateral side 348 A and the second lateral side 348B toward the corner portion 1078 at the one of the first lateral side 348 A or the second lateral side 348B when the user is laying on their side with the diversion member 110 coupled to the user. This can help to mitigate urine leaking out of the proximal end 110A of the diversion member 110.

[0208] In some examples, the comer portions 1078 can be located closer to the distal end 110B of the diversion member 110 than the proximal end 110A of the diversion member 110. This can help to direct urine distally even when the urine diversion device 1000 is oriented horizontally.

[0209] As shown in Figures 10A-10B, the urine diversion device 1000 can also include a suction tube 1080 in the internal cavity 112 of the diversion member 110, and in fluid communication with the port 120. The suction tube 1080 can be configured to direct urine from the corner portions 1078 to the port 120 of the outlet 118 (e.g., under vacuum pressure from the vacuum device 238). For instance, the suction tube 1080 can have a first section 1080 A and a second section 1080B that extend on opposing sides of the port 120 toward the corner portions 1078. The first section 1080A can include a first aperture 1082A at the comer portion 1078 on the first lateral side 348 A, and the second section 1080B can include a second aperture 1082B at the corner portion 1079 on the second lateral side 348B. In this arrangement, the suction tube 1080 can apply suction to the corner portions 1078 through the first aperture 1082A and the second aperture 1082B to divert urine from the comer portions 1078 to the port 120. The suction tube 1080 extending laterally from the port 120 toward the first lateral side348A and toward the second lateral side 348B can also help to mitigate kinking at the distal end HOB of the diversion member 110.

[0210] Additionally, the suction tube 1080 can include a third aperture 1082C between the first section 1080 A and the second section 1080B. The third aperture 1082C can be configured to receive urine that is distal of the first aperture 1082A and the second aperture 1082B into the suction tube 1080 and / or the port 120. As such, when the diversion member 110 is oriented vertically, at least a portion of urine may flow distally past the first aperture 1082 A and the second aperture 1082B, and pass through the third aperture 1082C into the port 120. Accordingly, in the arrangement shown in Figures 10A-10B, the urine diversion device 1000 can better divert urine to the outlet 118 regardless of the orientation of the diversion member 110 relative to a force of gravity.

[0211] In some examples, the suction tube 1080 can have an inner diameter that is greater than an inner diameter of the port 120. This can help to avoid limiting a flow of the urine from the suction tube 1080 to the port 120. Additionally, the inner diameter of the suction tube 1080 and the port 120 can be greater than an inner diameter of the drain tube 234 (shown in Figure 2) as this can help to overcome flow rate losses due to suction pressure loses that are divided over the first aperture 1082A, the second aperture 1082B, and the third aperture 1082C.

[0212] As shown in Figures 10A-10B, the urine diversion device 1000 can include a first spacer 1030A and a second spacer 1030B in the internal cavity 112 of the diversion member 110. The first spacer 1030A can extend along the first lateral side 348A and the second spacer 1030B can extend along the second lateral side 348B such that a gap is defined between the first spacer 1030A and the second spacer 1030B. Additionally, in this example, the first spacer 1030 A and the second spacer 1030B can extend from the opening 116 to the first aperture 1082A and the second aperture 1082B of the suction tube 1080. The first spacer 1030 A and the second spacer 1030B can help to maintain the diversion member 110 open and mitigate a vacuum lock event.

[0213] In Figures 10A-10B, the first spacer 1030 A and the second spacer 1030B are formed from a foam material. However, in other examples, the first spacer 1030A and / or the second spacer 1030B can be additionally or alternatively formed from any of the other materials described above with respect to the spacer 130.

[0214] The urine diversion device 1000 can also include a fabric 1052 in the internal cavity 112 at or around the opening 116 to help mitigate leakage. For instance, the fabric 1052can include the permeable layer 352A and / or the wi eking layer 352B described above. In one example, the fabric 1052 can be coupled to an interior surface of the bottom wall 314B.

[0215] In this example, the urine diversion device 1000 includes a first attachment member 1024A, which is substantially similar or identical to the first attachment member 324A described above. The urine diversion device 1000 can also include a second attachment member 1024B for coupling the top wall 314A to the user. The second attachment member 1024B is substantially similar or identical to the second attachment member 324B, except the second attachment member 1024B is smaller and closer to the proximal end 110A of the diversion member 110 in this example. The first attachment member 1024A and / or the second attachment member 1024B can be configured differently as described above.

[0216] In the examples shown in Figures 3A-10B, the first attachment member 324A, 924A, 1024A is fixedly coupled to the diversion member 110 such that the first attachment member 324A, 924A, 1024A is not rotatable relative to the diversion member 110. This can simplify a manufacturing process and / or reduce a cost of manufacture. However, as described above, the attachment member(s) 124 can be rotatably coupled to the diversion member 110 such that the diversion member 110 can rotate relative to the attachment member(s) 124 and the body of the user.

[0217] Figures 11A-11E depict a urine diversion device 1100 in which the first attachment member is rotatably coupled to the diversion member 110. Figure 11 A depicts the urine diversion device 1100 coupled to a user in a first rotational position, Figure 1 IB depicts the urine diversion device 1100 coupled to the user in a second rotational position, Figure 11C depicts a backing member for rotatably coupling the diversion member 110 to a user, Figure 1 ID depicts a protrusion for rotatably coupling the diversion member 110 to the user, Figure HE depicts a track for rotatably coupling the diversion member 110 to the user, Figure 1 IF depicts a first attachment member 1124 A of the urine diversion device 1000 coupled to a user and the diversion member 110 decoupled from the first attachment member 1124A, and Figure 11G depicts the diversion member 110 decoupled from the first attachment member 1124A, according to an example.

[0218] As shown in Figures 11A-11B, the urine diversion device 1100 includes the diversion member 110 extending from the proximal end 110A to a distal end HOB. In this example, the bottom wall 314B of the diversion member 110 includes the opening 116 that provides access to the internal cavity 112 of the diversion member 110. The urine diversiondevice 1100 also includes the outlet 118 for egressing urine from the internal cavity 112 of the diversion member 110. The urine diversion device 1100 can include any one or more of the other features described above with respect to Figures 1-10B.

[0219] The urine diversion device 1100 also includes a first attachment member 1124A rotatably coupled to the bottom wall 314B of the diversion member 110. As shown in Figures 11C-11G, the first attachment member 1124A includes a backing member 1184, a protrusion 1186, and a track structure 1188. The backing member 1184 has a first side 1184A, a second side 1184B, and an aperture 1184C extending through the first side 1184A and the second side 1184B. The first side 1184A includes an adhesive that is configured to couple to a skin of a user.

[0220] The backing member 1184 can provide a support structure for coupling either the protrusion 1186 or the protrusion 1186 to the skin of the user via the adhesive on the first side 1184A. As shown in Figures 11C and 1 IF, the backing member 1184 can include a slit 1184D that extends from the aperture 1184C. The slit 1184D can help to facilitate inserting the penis through the aperture 1184C and / or adjusting a size of the aperture 1184C to better fit the anatomy of the user, as described above. In one example, the backing member 1184 can comprise a foam pad.

[0221] The protrusion 1186 is on one of the second side 1184B of the backing member 1184 or the bottom wall 314B of the diversion member 110, and the track structure 1188 is on another one of the second side 1184B of the backing member 1184 or the bottom wall 314B of the diversion member 110. In Figures 1 IF- 11G, the protrusion 1186 is coupled to an exterior surface of the bottom wall 314B, and the track structure 1188 is coupled to the backing member 1184. However, in other examples, the protrusion 1186 can be coupled to the backing member 1184, and the track structure 188 can be coupled to the bottom wall 314B instead.

[0222] In Figures 11 A-l IB, the track structure 1188 is coupled to the protrusion 1186 such that (i) the track structure 1188 constrains movement of the protrusion 1186 in a direction extending from the first side 1184A toward the second side 1184B and (ii) permits circumferential movement of the protrusion 1186 about the aperture 1184C of the backing member 1184 and the opening 116 of the diversion member 110. For instance, the track structure 1188 can include a channel 1188 A defined by a plurality of guide walls 1188B, and the protrusion 1186 can have a size and a shape that permits the protrusion 1186 to move withinthe channel 1188 A while the guide walls 1188B inhibit the protrusion 1186 from moving out of the channel 1188 A.

[0223] To provide for rotational movement of the diversion member 110 relative to the first attachment member 1124A, the channel 1188A of the track structure 1188 can be curved. For instance, the channel 1188A can define a partial circle that extends around the opening 116 of the diversion member 110. In one example, the track structure 1188 can extend around at least half of a circumference of the opening 116. This can provide for the diversion member 110 rotating at least 180 degrees relative to the first attachment member 1124 A (and the user), which can allow for the diversion member 110 to be oriented parallel to a direction of gravity 1189 while the user is lying on either side, while the user is sitting up, and while the user is lying on their back.

[0224] As shown in Figures HE and 11G, the protrusion 1186 can have a curved shape. Within examples, a radius of curvature of the protrusion 1186 can generally correspond to a radius of curvature of the channel 1188 A to provide for movement of the protrusion 11886 in and along the channel 1188A of the track structure 1188. The protrusion 11886 can also have a size that is greater than a size of a gap between respective ones of the guide walls 1188B to prevent the protrusion 1186 from moving out of the channel 1188 A of the track structure 1188. Additionally, the guide walls 1188B can include a stop 1188D at opposing ends of the channel 1188 A to limit an extent of movement of the protrusion 1186 along the track structure 1188 and prevent the protrusion 1186 from moving out of the ends of the channel 1188 A.

[0225] Referring now to Figures 12A-12C, a urine diversion device 1200 is shown according to another example. Figure 12A depicts a top side of the urine diversion device 1200, Figure 12B depicts a bottom side of the urine diversion device 1200, and Figure 12C depicts an exploded view of the urine diversion device 1200. The urine diversion device 1200 is substantially similar or identical to the urine diversion device 300 described above with respect to Figures 3A-3E, except the urine diversion device 1200 includes the secondary opening 117, the wi eking layer 352B, and the outlet 118 have a different configuration according to another example.

[0226] As shown in Figures 12A-12C, the urine diversion device 1200 includes the diversion member 110 extending between the proximal end 110A and the distal end HOB, the opening 116 in the diversion member 110, the outlet 118, the first attachment member 324A, and the second attachment member 324B as described above. The diversion member 110 alsoincludes the secondary opening 117 at the proximal end 110A. In this example, the secondary opening 117 extends across only a first portion of the width of the diversion member 110, and a second portion of the width of the diversion member 110 is sealed. For instance, the diversion member 110 includes a plurality of proximal seams 1290 (e.g., direct couplings between the top wall 314A and the bottom wall 314B) on opposing sides of the secondary opening 117 at the proximal end 110A. The proximal seams 1290 can help to mitigate leakage of urine out the secondary opening 117 at the proximal end 110A. One of the proximal seams 1290 extend inwardly from the first lateral side 348 A towards the secondary opening 117 and the other of the proximal seams 1290 extends inwardly from the second lateral side 348B towards the secondary opening 117. In this arrangement, the proximal seams 1290 can assist in arranging the proximal end 110A with the secondary opening 117 extending across less than an entire width of the diversion member 110, thereby reducing a size of the secondary opening 117 relative to the implementation shown in Figures 3 A-3E, which omit the proximal seams 1290.

[0227] As shown in Figure 12C, the urine diversion device 1200 can include the permeable layer 352A, the wicking layer 352B, and the spacer 130 as described above. In this example, the opening 116 in the bottom wall 314B has a first size and a first shape, and the permeable layer 352A includes a first aperture 1252A that also has the first size and the first shape. The wicking layer 352B has a proximal opening 1252B, and the first attachment member 324A includes an adhesive opening 1224. As shown in Figure 12C, the proximal opening 1252B of the wicking layer 352B and the adhesive opening 1224 of the first attachment member 324A can have a greater size and a different shape than the opening 116 of the bottom wall 314B and the first aperture 1252 A of the permeable layer 352 A.

[0228] In this example, the wicking layer 352B may not be directly coupled to the permeable layer 352A and the bottom wall 314B, but rather the wicking layer 352B can float between the permeable layer 352A and the bottom wall 314B. In this arrangement, a position of the wicking layer 352B between the permeable layer 352A and the bottom wall 314B can be maintained by a direct coupling between the permeable layer 352 A and the bottom wall 314B, where the direct coupling extends entirely around a periphery of the wicking layer 352B. This coupling of the permeable layer 352 A and the bottom wall 314B can be achieved at least in part due to the proximal opening 1252B of the wicking layer 352B having a greater size and / or a different shape than the opening 116 of the bottom wall 314B and / or the first aperture 1252 A of the permeable layer 352 A.

[0229] Additionally, the wi eking layer 352B can include a window aperture 1292 in a middle portion of the wi eking layer 352B. The window aperture 1292 can allow the permeable layer 352A to be coupled to the bottom wall 314B through the window aperture 1292. This can further assist in maintaining a position of the wi eking layer 352B relative to the bottom wall 314B and / or the permeable layer 352A, and / or mitigate the wicking layer 352B rolling or folding up on itself in a space between the permeable layer 352 A and the bottom wall 314B.

[0230] In the example shown in Figures 12A-12C, the outlet 118 includes a stub tube 1294, the port tube 122, and the port 120. The stub tube 1294 can be directly coupled to the diversion member 110. For instance, the stub tube 1294 can be welded (e.g., impulse welded) to the top wall 31 A and the bottom wall 314B of the diversion member 110. A first end of the port tube 122 can be coupled to stub tube 1294, and a second end of the port tube 122 can be coupled to the port 120.

[0231] In one example, the stub tube 1294 can have a length of approximately 0.75 inches (i.e., approximately 19.05 mm), an inner diameter of approximately 0.25 inches (i.e., approximately 6.35 mm), an outer diameter of approximately 0.375 inches (i.e., approximately 9.525 mm), and / or a thickness of approximately 0.125 inches (i.e., approximately 3.175 mm). One or more of these dimensions can help to mitigate occlusion of the outlet 118 (e.g., in an event that the outlet 118 full flips over on itself while routing the port tube 122 and the port 120 towards the proximal end 110A).

[0232] In Figures 12A-12C, the stub tube 1294 has a shape of a cylindrical tube and / or the stub tube 1294 can non-rotationally coupled the port tube 122 and the port 120 to the diversion member 110. However, in other examples, the stub tube 1294 can have other shapes and / or sizes, and / or the stub tube 1294 can be configured to rotationally couple the port tube 122 and the port 120 to the diversion member 110.

[0233] Figure 13 depicts a stub tube 1394 according to another example. The stub tube 1394 can couple the port tube 122 and the port 120 to the diversion member 110 as described above. As shown in Figure 13, the stub tube 1394 can includes an outer tube 1394A that fixedly couples to the diversion member 110, and an inner tube 1394B that is rotationally coupled to the outer tube 1394A. The inner tube 1394B can be disposed in a lumen of outer tube 1394 A.

[0234] Additionally, the stub tube 1394 can include an axial retention structure that can axially retain the inner tube 1394B in the lumen of the outer tube 1394A. In this example,the inner tube 1394B includes a protrusion that extends around a circumference of an exterior surface of the inner tube 1394B, and the outer tube 1394 A includes a groove that extends around a circumference of an inner surface of the outer tube 1394 A. The groove of the outer tube 1394A is configured to receive the protrusion of the inner tube 1394B such that the engagement of the protrusion and the groove axially retain the inner tube 1394B in the lumen of the outer tube 1394 A. Additionally, the engagement between the protrusion and the groove can help to provide water-tight coupling between the outer tube 1394 A and the outer tube 1394 A.

[0235] In this arrangement, the outer tube 1394A is fixed relative to the diversion member 110, and the inner tube 1394B is rotatable relative to the diversion member 110. The inner tube 1394B can be configured to couple to the port tube 122 and / or the port 120. As a result, the stub tube 1394 can allow the port tube 122 and / or the port 120 to rotate relative to the diversion member 110.

[0236] In Figure 13, the outer tube 1394A includes two grooves and the inner tube 1394B includes two protrusions. However, in other examples, the outer tube 1394 A and the inner tube 1394B can include a different quantity of grooves. Additionally, in other examples, the inner tube 1394B can include one or more protrusions and the outer tube 1394 A can include one or more grooves instead. In still other examples, the outer tube 1394 A can include a first subset of the protrusions and a first subset of the recesses, and the inner tube 1394B can include a second subset of the protrusions for engaging the first subset of recesses a second subset of recesses for engaging the first subset of protrusions.

[0237] In some examples, the protrusion(s) and / or the recess(es) can extend entirely around a circumference of the outer tube 1394A and / or the inner tube 1394B. In other examples, the recess(es) can extend entirely around the circumference of the outer tube 1394 A and / or the inner tube 1394B, and the protrusion(s) can extend around less than an entirety of the outer tube 1394A and / or the inner tube 1394B.

[0238] In the example shown in Figure 13, the inner tube 1394B can freely rotate by greater than 360 degrees relative to the outer tube 1394 A. However, in other examples, the outer tube 1394A and / or the inner tube 1394B can include a stop in the recess(es) that can limit the extent of rotation to less than 360 degrees.

[0239] In one example, the recess can have a length (along a dimension extending along an axis of the lumen of the stub tube 1394) of approximately 0.125 inches and the outer tube 1394A can have a wall thickness of approximately 0.03 to approximately 0.0626 inches.

[0240] In Figure 13, the inner tube 1394B is a straight tube that does not have any bends (e.g., the inner tube 1394B extends entirely along a longitudinal axis). In other examples, the inner tube 1394B can have one or bends to help direct the port tube 122 away from the diversion member 110 in a direction that is transverse to the longitudinal axis of the diversion member 110. As one example, Figure 14 depicts a stub tube 1494 including an outer tube 1494A and an inner tube 1494B, which are identical to the stub tube 1394 of Figure 13, except the inner tube 1494B includes a bend at a portion of the inner tube 1494B that is outside of the outer tube 1494A.

[0241] Figure 15 depicts a stub tube 1594 according to another example. In Figure 15, the stub tube 1594 includes a shape retaining element 1594A and an inner tube 1594B coupled to the shape retaining element 1594A in an inner lumen of the shape retaining element 1594A. The shape retaining element 1594A is manually adjustable to a curved shape and retains the curved shape until a shape of the shape retaining element is manually adjusted again. In this arrangement, adjusting the shape of the shape retaining element 1594A also adjusts and maintains a shape of the inner tube 1594B within the lumen of the shape retaining element 1594A. This can provide for manually adjusting and readjusting a direction of the stub tube 1594 relative to the diversion member 110.

[0242] In this example, the shape retaining element includes a number of linking segments 1596. The linking segments 1596 include a first portion 1596A with a spherically shaped body, a second portion 1596B with a cylindrical shape, and a third portion 1596C having a semi -spherical shape forming a hollow cup. As such, the linking segments 1596 are configured to fit together by the first portion 1596A of a first linking segment 1596 fitting into a third portion 1596C of a second linking segment 1596 such that the linking segments 1596 are movable relative to each other. Additionally, the linking segments 1596 are hollow such that, when the linking segments 1596 are connected together to form the shape retaining element of the stub tube 1594, the linking segments 1596 define a lumen for receiving a portion of the inner tube 1594B. As shown in Figure 15, a portion of the inner tube 1594B can extend outwardly from the shape retaining element 1594A.

[0243] Referring now to Figures 16-21, a plurality of stub tubes are shown according to additional examples. The stub tubes shown in Figures 16-21 are each configured to couple to the distal end 11 OB of the diversion member 110 as described above. Additionally, the stub tubes are configured to couple to the port tube 122 and / or the port 120 as described above.

[0244] Figure 16 depicts a stub tube 1694 according to an example. The stub tube 1694 includes a proximal portion 1694A and a distal portion 1694B extending distally from the proximal portion 1694 A. The proximal portion 1694 A of the stub tube 1694 includes a first side 1698 A, a second side 1698B, a first lateral side 1698C, and a second lateral side 1696D. The first side 1698 A and the second side 1698 extend between the first lateral side 1698C and the second lateral side 1698D. The proximal portion 1694A defines a lumen between the first side 1698 A, the second side 1698B, the first lateral side 1698C, and the second lateral side 1698D, which is in fluid communication with a lumen of the distal portion 1694B of the stub tube 1694. The proximal portion 1694A can be sealed between the wall(s) 114 of the diversion member 110, and the distal portion 1694B can extend distally of the diversion member 110 to provide for coupling with the port tube 122 and / or the port 120. In other examples, the port 120 can be integrally formed with the distal portion 1694B.

[0245] In a dimension extending between of the first side 1698 A and the second side 1698B, a thickness of the proximal portion 1694A is greatest at a midpoint between the first lateral side 1698C and the second lateral side 1698D. In a direction from the midpoint toward the first lateral side 1698C, the thickness of the proximal portion 1694 A decreases such that the first side 1698 A and the second side 1698B taper towards each other. Similarly, in a direction from the midpoint toward the second lateral side 1698D, the thickness of the proximal portion 1694 A decreases such that the first side 1698 A and the second side 1698B taper towards each other. As shown in Figure 16, the first side 1698 A and the second side 1698B can taper to a thin edge at the first lateral side 1698C and a thin edge that the second lateral side 1698D. This can help to reduce or minimize a space between the top wall 314A and the bottom wall 314B of the diversion member 110 during a process for coupling the top wall 314A and the bottom wall 314B to each other around the proximal portion 1694 A of the stub tube 1694 during manufacture. As a result, the stub tube 1694 can be more efficiently coupled to the diversion member 110. For instance, a process coupling a circular shaped stub tube to the diversion member 110 may involve multiple RF welding steps, but a process for coupling the stub tube 1694 to the diversion member 110 may be completed in a single RF welding step.

[0246] Additionally, in some examples, the stub tube 1694 can be formed from an elastic material. This may further improve a process for coupling the stub tube 1694 to the diversion member 110 as it may allow the stub tube 1694 to be compressed down nearly as flat as a RF welding head(s) press down, which may help to obtain a good seal of the diversion member 110 around the stub tube 1694.

[0247] Figure 17 depicts a stub tube 1794 according to another example. The stub tube 1794 is identical to the stub tube 1694, except the second side 1698B extends proximally of a proximal end of the first side 1698 A. This can help to mitigate the diversion member 110 collapsing around the lumen of the proximal portion 1694A and occluding the stub tube 1794.

[0248] Figure 18 depicts a stub tube 1894 according to another example. The stub tube 1794 is identical to the stub tube 1694, except the proximal portion 1694A includes a plurality of protrusions 1898 that extend proximally from a proximal end of the second side 16948B. The protrusions 1898 also extend proximally of a proximal end of the first side 1698 A. The protrusions 1898 can help to mitigate the diversion member 110 collapsing around the lumen of the proximal portion 1694A and occluding the stub tube 1894.

[0249] Figure 19 depicts a stub tube 1994 according to another example. The stub tube 1794 is identical to the stub tube 1694, except the proximal portion 1694A includes a plurality of protrusions 1998 that extend proximally from a proximal end of the first side and the second side 16948B. The protrusions 1998 extending from the first side 1698 A are coupled to respective ones of the protrusions 1998 extending from the second side 1698 by transverse segments. As shown in Figure 18, the lumen of the stub tube 1994 and portions of the proximal ends of the first side 1698 A and the second side 1698B are disposed between the protrusions 1198. This can help to mitigate the diversion member 110 collapsing around the lumen of the proximal portion 1694A and occluding the stub tube 1994.

[0250] Figure 20 depicts a stub tube 2094 according to another example. The stub tube 2094 is identical to the stub tube 1994, except the transverse segments extending between respective ones of the protrusions 1998 are curved instead of perpendicular to the protrusions 1998. The protrusions 1998 and the transverse segments can help to mitigate the diversion member 110 collapsing around the lumen of the proximal portion 1694 A and occluding the stub tube 2094.

[0251] Figure 21 depicts a stub tube 2194 according to another example. The stub tube 2194 is identical to the stub tube 1664, except the proximal portion 1694 A includes aplurality of protrusions 2198 that extend proximally from (i) a first interface between the first side 1698 A, the second side 1698B, and the first lateral side 1698C, and (ii) a second interface between the first side 1698 A, the second side 1698B, and the second lateral side 1698D. The protrusions 2198 are on opposing lateral sides of the lumen of the proximal portion 1694 A of the stub tube 2194. The protrusions 2198 extending proximally from the proximal ends of the first side 1698 A and the second side 1698B around the lumen of the stub tube 2194 can help to mitigate the diversion member 110 collapsing around the lumen of the proximal portion 1694A and occluding the stub tube 2094.

[0252] Referring now to Figures 22A-22E, the port 120 shown in Figures 12A-12C is depicted according to an example. Figure A is a perspective view of the port 120, Figure 22B is a side view of the port 120, Figure 22C is an end view of the port 120, Figure 22D is a cross- sectional view of the port 120 taken through a line A in Figure 22B, and Figure 22E is an enlarged view of a proximal end of the port 120 shown in Figure 22D, according to the example.

[0253] As shown in Figures 22A-22E, the port 120 extends between a proximal end 120A and a distal end 120B. The proximal end 120A of the port 120 can couple to the port tube 122 and / or the stub tube 1394, 1494, 1594, 1694, 1794, 1894, 1994, 2094, 2194. For instance, in this example, the proximal end 120A can include barb fitting for coupling to the port tube 122. The distal end 120B of the port 120 can couple to the drain tube 234. For instance, as described above, the distal end 120B includes a plurality of sections having different diameters to provide for coupling the port 120 with drain tubes 234 having different inner diameters.

[0254] Figures 23A-23G depict a port 2320 according to another example. Figure 23A is a perspective view of the port 2320, Figure 23B is a first end view of the port 2320, Figure 23C is a second end view of the port 2320, Figure 23D is a first side view of the port 2320, Figure 23E is a second side view of the port 2320, Figure 23F is a third side view of the port 2320, and Figure 23G is a fourth side view of the port 2320 according to the example.

[0255] As shown in Figures 23A-23B, the port 2320 extends between a proximal end 2320A and a distal end 2320B. The proximal end 2320A of the port 2320 can couple to the port tube 122 and / or the stub tube 1394, 1494, 1594, 1694, 1794, 1894, 1994, 2094, 2194. For instance, in this example, the proximal end 2320A can include barb fitting for coupling to the port tube 2322. The distal end 2320B of the port 2320 can couple to the drain tube 234. Forinstance, as described above, the distal end 2320B includes a plurality of sections having different diameters to provide for coupling the port 2320 with drain tubes 234 having different inner diameters.

[0256] Additionally, as shown in Figures 23A-23G, the port 2320 includes a grip portion 2320C between the proximal end 2320A and the distal end 2320B. The grip portion 2320C can be configured to allow a hand to hold the port 2320 more securely while coupling the port 2320 to the port tube 122 and / or while coupling the port 2320 to the drain tube 234. For instance, in Figures 23A-23G, the grip portion 2320C includes a concave surface that extends around a circumference of the port 2320. This can assist in gripping the port 2320 while providing a distally directed force and / or a proximally directed force during coupling of the port 2320 to the port tube 122 and / or the drain tube 234.

[0257] Referring to Figures 24A-24D, features for removably coupling a drain tube 234 to the diversion member 110 are shown according to examples. In Figure 24A, the diversion member 110 comprises a clip 2499A on an exterior surface of the diversion member 110. The clip 2499A is configured to couple the drain tube 234 to the diversion member 110. In Figure 24B, the diversion member 110 includes a strap 2499B with a first end coupled to the diversion member 110 and a second end having an adhesive. The strap 2499B is configured to extend around the drain tube 234 and couple to the diversion member 110 at the second end via the adhesive. In Figure 24C, the diversion member 110 includes a strap 2499C that has a button snap feature for coupling to a corresponding button snap feature on the diversion member 110. The strap 2499C is configured to extend over the drain tube 234 such that the drain tube 234 is between the strap 2499C and the diversion member 110. In Figure 24D, the diversion member 110 includes a tie strap 2499D that can wrap around a protrusion 2499E. The tie strap 2499D is configured to extend over the drain tube 234 and couple to the protrusion 2499E such that the drain tube 234 is between the tie strap 2499D and the diversion member 110.

[0258] Referring now to Figure 25, a urine diversion device 2500 is shown according to another example. The urine diversion device 2500 can be substantially similar or identical to the urine diversion devices 100, 300, 800, 900, 1000, 1100, 1200 described above, except the urine diversion device 2500 also includes a urine sensor 2511 that is configured to determine information relating to urine in the diversion member 110.

[0259] As examples, the urine sensor 2511 can include one or more sensors selected from a group consisting of: a pH sensor, a turbidity sensor, a colorimetric sensor, a spectrometer, an immunoassay, an enzyme-linked immunosorbent assay (ELISA). Additionally, as examples, the urine sensor 2511 can be configured to determine at least one type of information selected from a group consisting of: a concentration of calcium in the urine, a concentration of glucose in the urine, a concentration of protein in the urine, an amount of protein in the urine, a pH of the urine, a concentration of leukocytes in the urine, an amount of nitrogen, a concentration of nitrogen, an amount of ketones, a concentration of ketones, a concentration of bilirubin, an amount of creatinine, and a concentration of creatinine.

[0260] In some examples, the urine sensor 2511 can perform an analysis of the urine to determine the information and, based on the analysis, directly provide an indication of the information to a user. For instance, the urine sensor 2511 can be configured to provide a visual indication of the information to the user (e.g., by changing color to indicate the information).

[0261] In other examples, the urine sensor 2511 can (i) perform an analysis of the urine to determine the information, (ii) provide an indication of the information to an external computing device, (iii) the external computing device can further analyze the indication of the information, and (iv) the external computing device can communicate the information to the user. For instance, the external computing device can include a camera that can image the urine sensor 2511, and a processor that can determine, based on a color of the urine sensor 2511 in the image, the information. The external computing device can include one or more processors and a non-transitory computer readable medium (e.g., volatile and / or non-volatile memory) that stores machine language instructions or other executable instructions. The instructions, when executed by the one or more processors, cause the external computing device to carry out the various operations described herein. The external computing device, thus, can receive data and store the data in the memory as well. As examples, the external computing device can be a mobile phone, a tablet computer, and / or a personal computer (PC).

[0262] As shown in Figure 25, the urine sensor 2511 can be coupled to one of the walls 114 of the diversion member 110. In some examples, the urine sensor 2511 can be coupled on an interior surface of the wall 114. This can allow the urine sensor 2511 to directly contact the urine without embedding the urine sensor 2511 in the wall 114. However, in other examples, the urine sensor 2511 can be embedded in the wall 114. In still other examples, the urine sensor 2511 can be coupled to an exterior surface of the wall 114. This may be useful in implementations in which the wall 114 is formed from a transparent material and the urinesensor 2511 can analyze the urine without directly contacting the urine (e.g., by determining a color of the urine).

[0263] In some examples, the urine sensor 2511 can be positioned at a distal portion of the diversion member 110 (e.g., closer to the distal end HOB than the proximal end 110A). As urine flows distally in the urine the diversion member 110, the urine can flow towards the urine sensor 2511, which is located at or near the distal end HOB.

[0264] Referring now to Figure 26A, a urine diversion device 2600 is shown according to another example. The urine diversion device 2600 is substantially similar or identical to any of the urine diversion devices 100, 300, 800, 900, 1000, 1100, 1200, 2500 described above, except the urine diversion device 2600 includes a plurality of baffles 2613 in the diversion member 110. The baffles 2613 can help to inhibit (or prevent) a backflow of the urine in a direction towards the proximal end 110A of the diversion member 110. For instance, the baffles 2613 can help to mitigate urine flowing in a proximal direction towards the proximal end 110A while the user is laying on their side instead of sitting upright or laying on their back.

[0265] Figure 26B depicts the diversion member 110 and the baffles 2613 of the urine diversion device 2600 shown in Figure 26A along with urine within the diversion member 110. In the example shown in Figures 26A-26B, the baffles 2613 extend from the first lateral side 348 A and the second lateral side 348B toward a center axis 2617 of the diversion member 110. By extending from both the first lateral side 348A and the second lateral side 348B can help to mitigate backflow of urine towards the proximal end 110A when the user lays on their left side or the right side of their body. The baffles 2613 can also alternate between extending from the first lateral side 348A and the second lateral side 348B. This can help to define a tortious pathway, which can help to further mitigate backflow of the urine. The baffles 2613 can additionally be sloped in a proximal direction as the baffles 2613 extend from the first lateral side 348A and the second lateral side 348B. This can help to better trap urine and mitigate urine from flowing in a proximal direction when the user lays on their side.

[0266] As shown in Figures 26A-26B, the baffles 2613 can be positioned in the second chamber 354B of the diversion member 110.

[0267] As described above with respect to Figure 2, the system 232 includes the vacuum device 238. As described above, the vacuum device 238 can include an air pump or other vacuum source, which is coupled to the waste collection reservoir 236 by an air tube 242. However, in another example, the vacuum device 238 can be a hand-operated pump coupledto the waste collection reservoir 236 by the air tube 242. This may be beneficial when other types of the vacuum device 238 are not available such as, for instance, when the urine diversion device 2600 is used outside of a healthcare facility. The hand-operated pump 2638 can help to enhance a mobility of a user when using the urine diversion device 2600 (or the other implementations of the urine diversion device 100, 300, 800, 900, 1000, 1100, 1200, 2500 described above).

[0268] As an example, Figures 26C-26E depict the urine diversion device 2600 coupled to the waste collection reservoir 236 by the drain tube 234, and the waste collection reservoir 236 coupled to a hand-operated pump 2638 by the air tube 242. In one example, the hand-operated pump 2638 can include a suction bulb. Compressing the suction bulb can decrease a volume of air inside the suction bulb, which can cause the air pressure in the suction bulb to increase. When the suction bulb is released, the air pressure inside the suction bulb decreases, which creates a pressure difference between the air inside the suction bulb and the air outside the suction bulb and results in a suction force. Therefore, in this example, when the hand-operated pump 2638 is compressed and released, the hand-operated pump 2638 can produce suction in the air tube 242, the waste collection reservoir 236, the drain tube 234, the outlet 118, and the internal cavity 112 of the diversion member 110.

[0269] Additionally, as shown in Figures 26C-26E, the system 232 includes a oneway valve 2615 coupling the drain tube 234 to the outlet 118 of the diversion member 110. The one-way valve 2615 is actuatable between an open state shown in Figure 26D and a closed state shown in Figure 26E. When the one-way valve 2615 is in the closed state shown in Figure 26E, the one-way valve 2615 prevents urine from flowing from the outlet 118 to the drain tube 234 and prevented from flowing from the drain tube 234 to the outlet 118. When the one-way valve 2615 is in the open state, the urine is permitted to flow from the outlet to the drain tube 234 and prevented from flowing from the drain tube 234 to the outlet 118. In this arrangement, the user can actuate the one-way valve 2615 to the closed state, the user can decouple the outlet 118 from the waste collection reservoir 236 (e.g., by decoupling the outlet 118 from the drain tube 234 and / or decoupling the drain tube 234 from the waste collection reservoir 236) and move about without urine leaking out. When the user is ready to void into the urine diversion device 2600 and / or when the user is ready to drain urine already voided into the urine diversion device 2600, the user can couple the outlet 118 to the waste collection reservoir 236 and actuate the one-way valve 2615 to the open position.

[0270] As shown in Figures 26D-26E, the one-way valve 2615 can include a knob that is rotatable to actuate the one-way valve 2615 between the closed state and the open state. In the example shown in Figures 26D-26E, the knob extends parallel to a coupling with the drain tube 234 when the one-way valve 2615 is in the open position, and the knob extends transverse or perpendicular to the coupling with the drain tube 234 when the one-way valve 2615 is in the closed position.

[0271] Referring now to Figures 27A-27B, a urine diversion device 2700 is shown according to another example. The urine diversion device 2700 is substantially similar or identical to any of the urine diversion devices 100, 300, 800, 900, 1000, 1100, 1200, 2500, 2700 described above, except the urine diversion device 2700 includes a third attachment member 2724 and a secondary fluid reservoir 2719.

[0272] The third attachment member 2724 can be in addition or in alternative to the first attachment member 324A, 924A, 1024A, 1124A and / or the second attachment member 324B, 924B, 1024B, 1124B described above. In this example, the third attachment member 2724 can include a waistband 2724A that is configured to be worn around a waist of the user, and the diversion member 110 is coupled to the waistband 2724A. The third attachment member 2724 can beneficially help to better secure the urine diversion device 2700 to the user when the user is mobile (e.g., when the user is not sitting in a chair or laying on a bed).

[0273] In Figures 27A-27B, the waistband 2724A is coupled to the top wall 314A of the diversion member 110. For example, the waistband 2724A can be coupled to a portion of the top wall 314A that is proximal of the opening 116 in the bottom wall 314B and / or a proximal-most end of the bottom wall 314B. In implementation that include the second attachment member 324B, the waistband 2724A can also be distal of the adhesive of the second attachment member 324B. This can allow the third attachment member 2724 to couple to the waist of the user with the second attachment member 324B above the waistband 2724A and the first attachment member 324A coupled to the user below the waistband 2724A. As noted above, the urine diversion device 2700 can omit the first attachment member 324A and / or the second attachment member 324B in other examples.

[0274] The third attachment member 2724 can additionally include one or more fasteners 2724B for coupling the waistband 2724A to the user. As examples, the fastener(s) 2724B can include at least one fastener selected from a group consisting of: (i) a hook-and- loop fastener, (ii) a buckle, (iii) a loop and clip coupling, and (iv) a button and a button holecoupling. In some examples, the fastener(s) 2724B can be configured to adjust a size of a circumference of the waistband 2724A. This can help to accommodate a range of waist sizes.

[0275] In some examples, the waistband 2724A can be formed from an elastic material. This can additionally or alternatively assist in accommodating a range of waist sizes and / or enhancing user comfort. In other examples, the waistband 2724A can be formed from an inelastic material. This may be beneficial in some implementations in which the fastener(s) 2724B can provide for adjusting the circumference of the waistband 2724A so that the waistband 2724A more is more securely coupled to the user.

[0276] The secondary fluid reservoir 2719 is coupled to the outlet 118 by a tube 2721. As shown in Figure 27B, the urine diversion device 2700 includes a leg strap 2723 that is configured to couple the secondary fluid reservoir 2719 to a leg of the user. The tube 2721 can thus have a length that suitable to allow the diversion member 110 to be coupled around the penis of the user and the secondary fluid reservoir 2719 to be coupled by the leg strap 2723 to the leg of the user.

[0277] In this arrangement, an inlet of the secondary fluid reservoir 2719 is coupled to the outlet 118 of the diversion member 110 such that urine received in the internal cavity 112 of the diversion member 110 flows along the tube 2721 from the diversion member 110 to the secondary fluid reservoir 2719. In particular, when the user is mobile (e.g., standing, walking, or running), the urine can flow from the diversion member 110 to the secondary fluid reservoir 2719 under a force of gravity. By egressing the urine from the diversion member 110 to the secondary fluid reservoir 2719, contact between the skin of the user (e.g., the penis of the user) with the urine can be reduced while the user is mobile and presently unable to fully evacuate the urine from the urine diversion device 2700. In one example, the secondary fluid reservoir 2719 can have a volume of approximately 400 milliliters (ml).

[0278] As shown in Figures 27A-27b, the leg strap 2723 is configured to be worm around the leg of the user. In some examples, the leg strap 2723 can include one or more fasteners 2725 for coupling the waistband 2724A to the user. As examples, the fastener(s) 2725 can include at least one fastener selected from a group consisting of (i) a hook-and-loop fastener, (ii) a buckle, (iii) a loop and clip coupling, and (iv) a button and a button hole coupling. In some examples, the fastener(s) 27254 can be configured to adjust a size of a circumference of the leg strap 2723. This can help to accommodate a range of leg sizes.

[0279] In some examples, the leg strap 2723 can be formed from an elastic material. This can additionally or alternatively assist in accommodating a range of leg sizes, and / or enhancing user comfort. In other examples, the leg strap 2723 can be formed from an inelastic material. This may be beneficial in some implementations in which the fastener(s) 2725 can provide for adjusting the circumference of the leg strap 2723 so that the leg strap 2723 more is more securely coupled to the user.

[0280] As shown in Figures 27A-27B, the leg strap 2723 can have a height that is equal to or greater than a height of the secondary fluid reservoir 2719. This can help to reduce bulging under clothes, enhance user comfort, and / or enhance a coupling of the secondary fluid reservoir 2719 to the leg of the user.

[0281] In some examples, the secondary fluid reservoir 2719 can be coupled to the leg strap 2723. This can help to prevent the secondary fluid reservoir 2719 slipping out from under the leg strap 2723 when coupled to the leg of the user. As examples, the secondary fluid reservoir 2719 can be coupled to the leg strap 2723 by at least one coupling selected from among a group consisting of: an adhesive, stitching, a heat melt, a bonding, a hook-and-loop coupling, a button and button hole coupling, a snap coupling, and a RF welding. In other examples, the secondary fluid reservoir 2719 can be decoupled from the leg strap 2723 when the leg strap 2723 is not coupled to the user.

[0282] As shown in Figure 27A, the secondary fluid reservoir 2719 includes a secondary outlet 2727 that is configured to drain the secondary fluid reservoir 2719. In the illustrated example, the secondary outlet 2727 can include the one-way valve 2615 described above with respect to Figures 26C-26E. The one-way valve 2615 is actuatable between the open state and the closed state, as described above. In some examples, the secondary outlet 2727 can be configured to couple to the drain tube 34 of the system 232 (shown in Figure 2 and / or Figure 26C), and the one-way valve 2615 can be actuated to the open state to drain the secondary fluid reservoir 2719. In other examples, given that the user using the urine diversion device 2700 of Figures 27A-27B may be mobile, the user may actuate the one-way valve 2615 to drain urine from the secondary fluid reservoir 2719 without coupling the secondary outlet 2727 to the drain tube 234. For instance, the tube 2721 and the secondary fluid reservoir 2719 can allow for the secondary outlet 2727 to be positioned above a toilet such that actuating the one-way valve 2615 to the open state drains the urine from the secondary fluid reservoir 2719 into the toilet.

[0283] Referring now to Figures 28A-28B, a urine diversion device 2800 is shown according to another example. Figure 28A depicts the urine diversion device 2800 in a partially opened state on a user, and Figure 28B depicts the urine diversion device 2800 in a closed state on the user, according to the example. The urine diversion device 2800 is substantially similar or identical to any of the urine diversion device 2700 described above, except the urine diversion device 2700 includes the third attachment member 2724 in the form of a wearable garment 2824.

[0284] As shown in Figures 28A-28B, the urine diversion member includes the wearable garment 2824. The wearable garment 2824 can include at least one bottom selected from a group consisting of a pair of underwear, a pair of pants, and a pair of shorts. As such, the wearable garment 2824 can include a crotch portion 2824A, a first leg portion 2824B extending from the crotch portion 2824A, and a second leg portion 2824C extending from the crotch portion 2824A.

[0285] The wearable garment 2824 can be in addition or in alternative to the first attachment member 324A, 924A, 1024A, 1124A and / or the second attachment member 324B, 924B, 1024B, 1124B described above. In the example illustrated in Figures 28A-28B, the urine diversion device 2800 includes the first attachment member 324A and omits the second attachment member 324B, 924B, 1024B, 1124B. In other examples, the urine diversion device 2800 can also omit the first attachment member 324A such that the urine diversion device 2800 is coupled to the user by only the wearable garment 2824. In other examples, the urine diversion device 2800 can also include the second attachment member 324B, 924B, 1024B, 1124B in addition or in alternative to the first attachment member 324A, 924A, 1024A, 1124A.

[0286] The diversion member 110 is configured to be between the wearable garment 2824 and a skin of the user when the urine diversion device 2800 is in the closed state shown in Figure 28B. For instance, the diversion member 110 can be disposed on an inner surface of the crotch portion 2824A of the wearable garment 2824 (which faces the skin of the user), or the diversion member 110 can be coupled to the inner surface of the crotch portion 2824 A of the wearable garment 2824. In examples in which the diversion member 110 includes another attachment member (e.g., the first attachment member 324A, 924A, 1024A, 1124A and / or the second attachment member 324B, 924B, 1024B, 1124B), the diversion member 110 and the attachment member are configured to be between the wearable garment 2824 and the skin of the user when the attachment member couples the diversion member 110 to the user.

[0287] In some examples, the wearable garment 2824 can include one or more couplings between a front side of the wearable garment 2824 and a back side of the wearable garment 2824, which can help to provide easier access to the diversion member 110. For instance, as shown in Figures 28A-28B, the wearable garment 2824 can include a first coupling 2829A between the front side and the back side of the wearable garment 2824, and a second coupling 2829B between the front side and the back side of the wearable garment 2824. The first coupling 2829A and / or the second coupling 2829B can decouple at least a portion of the front side of the wearable garment 2824 from at least a portion of the back side of the wearable garment 2824 when the urine diversion device 2800 is in an open state or the partially open state shown in Figure 28A. The first coupling 2829A and / or the second coupling 2829B can couple the front side of the wearable garment 2824 to the back side of the wearable garment 2824 when the urine diversion device 2800 is in the closed state shown in Figure 28B.

[0288] As shown in Figures 28A-28B, the first coupling 2829A can be on a first lateral side of the wearable garment 2824 and the second coupling 2829B can be on a second lateral side of the wearable garment 2824. This can help to provide access to an entirety of the interior surface of the front side of the wearable garment 2824 while the back side of the wearable garment 2824 is positioned on or underneath the user as shown in Figure 28A, which can help to facilitate coupling the diversion member 110 to the user and / or decoupling the diversion member 110 from the user.

[0289] In the illustrated example, the first coupling 2829A includes a first outseam formed from a hook-and-loop material and the second coupling 2829B includes a second outseam formed from the hook-and-loop material. In other examples, the first coupling 2829 A and / or the second coupling 2829B can include at least one fastener selected from a group consisting of: a hook-and-loop coupling, a button and button hole coupling, a snap coupling, and a zipper.

[0290] The secondary fluid reservoir 2719 is coupled to the outlet 118 by the tube 2721 in a manner similar to that shown in Figures 27A-27B. As shown in Figure 28B, the secondary fluid reservoir 2719 is coupled to wearable garment 2824 such as, for example, the second leg portion 2824C of the wearable garment 2824. The tube 2721 can thus have a length that suitable to allow the diversion member 110 to be coupled around the penis of the user and the secondary fluid reservoir 2719 to be coupled by the second leg portion 2824C of the wearable garment 2824 while the wearable garment 2824 is word by the user.

[0291] In this arrangement, an inlet of the secondary fluid reservoir 2719 is coupled to the outlet 118 of the diversion member 110 such that urine received in the internal cavity 112 of the diversion member 110 flows along the tube 2721 from the diversion member 110 to the secondary fluid reservoir 2719. In particular, when the user is mobile (e.g., standing, walking, or running), the urine can flow from the diversion member 110 to the secondary fluid reservoir 2719 under a force of gravity. By egressing the urine from the diversion member 110 to the secondary fluid reservoir 2719, contact between the skin of the user (e.g., the penis of the user) with the urine can be reduced while the user is mobile and presently unable to fully evacuate the urine from the urine diversion device 2800.

[0292] In some examples, the secondary fluid reservoir 2719 can be coupled to the second leg portion 2824C of the wearable garment 2824. This can help to prevent the secondary fluid reservoir 2719 slipping out from under the wearable garment 2824 when the wearable garment is worn by the user. As examples, the secondary fluid reservoir 2719 can be coupled to the second leg portion 2824C by at least one coupling selected from among a group consisting of: an adhesive, stitching, a heat melt, a bonding, a hook-and-loop coupling, a button and button hole coupling, a snap coupling, and a RF welding.

[0293] In another example, the secondary fluid reservoir 2719 can be disposed in a pocket 2831 of the wearable garment 2824. This can allow the secondary fluid reservoir 2719 to be removably coupled to the wearable garment 2824, which can help to facilitate draining the secondary fluid reservoir 2719 and / or replacing the secondary fluid reservoir 2719.

[0294] In some examples, the secondary fluid reservoir 2719 can include a secondary outlet 2827 that is configured to drain the secondary fluid reservoir 2719. For instance, in Figure 28B, the secondary fluid reservoir 2719 includes a port tube 2822 and a port 2820, which can be substantially similar or identical to the port tube 122 and the port 120 described above. Accordingly, in this example, the secondary outlet 2827 can be configured to couple to a vacuum source (e.g., the vacuum device 238 and / or the hand-operated pump 2638). In other examples, the secondary outlet 2827 can additionally or alternatively include the one-way valve 2615 described above.

[0295] In some examples, the wearable garment 2824 can be formed from an elastic material. For instance, in the illustrated example of Figures 28A-28B, the wearable garment 2824 is in the form of a pair of compression shorts. This can help to reduce bulging underclothes, enhance user comfort, and / or enhance a coupling of the diversion member 110 to the user and / or coupling of the secondary fluid reservoir 2719 to the leg of the user.

[0296] Referring now to Figure 29, a flowchart for a process 2900 for diverting urine is illustrated according to an example embodiment. As shown in Figure 29, at block 2910, the process 2900 includes receiving a penis of a user in an internal cavity of a diversion member through an opening of the diversion member. At block 2912, the process 2900 includes coupling the diversion member to the user by an attachment member. After coupling the diversion member to the user at block 2912, the process 2900 can include receiving, from the penis, urine in the internal cavity of the diversion member at block 2914. At block 2916, the process 2900 can include egressing the urine from the diversion member via an outlet of the diversion member.

[0297] Figure 30-34 depicts additional aspects of the process 2000 according to further examples. As shown in Figure 30, the process 2900 can also include bending the diversion member at a position at which a spacer is disposed in the internal cavity at block 2918. The spacer can include one or more preferential separation regions.

[0298] As shown in Figure 31, the process 2900 can include blocking, using a proximal wall extending between a top wall and a bottom wall of the diversion member, the urine from leaking out a proximal end of the diversion member at block 2920.

[0299] As shown in Figure 32, the process 2900 can include directing, by a hydrophobic layer in the internal cavity, urine distally towards the outlet at block 2922.

[0300] As shown in Figure 33, the process 2900 can include directing urine along a first lateral side of the diversion member to a comer portion of the diversion member and using a suction tube to egress the urine from the comer portion through the outlet.

[0301] As shown in Figure 34, the process 2900 can include, after coupling the diversion member to the user at block 2912, rotating the diversion member relative to the attachment member at block 2926.

[0302] The description of the different advantageous arrangements has been presented for purposes of illustration and description, and is not intended to be exhaustive or limited to the embodiments in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art. Further, different advantageous embodiments may describe different advantages as compared to other advantageous embodiments. The embodiment or embodiments selected are chosen and described in order to explain the principles of theembodiments, the practical application, and to enable others of ordinary skill in the art to understand the disclosure for various embodiments with various modifications as are suited to the particular use contemplated.

Claims

CLAIMSWhat is claimed is:

1. A urine diversion device, comprising: a diversion member extending from a proximal end to a distal end, wherein the diversion member comprises an opening that is configured to provide access to an internal cavity of the diversion member; a spacer in the internal cavity, wherein the spacer comprises:(i) a proximal-spacer end,(ii) a distal-spacer end,(iii) a first lateral side,(iv) a second lateral side,(v) a first major surface extending between the proximal-spacer end, the distal-spacer end, the first lateral side, and the second lateral side,(vi) a second major surface extending between the proximal-spacer end, the distal-spacer end, the first lateral side, and the second lateral side, and(vii) one or more preferential separation regions in at least one of the first major surface or the second major surface; one or more attachment members configured to couple the diversion member to a user; and an outlet for egressing urine from the internal cavity of the diversion member, wherein the diversion member is suitable to direct urine toward the outlet.

2. The urine diversion device of claim 1, wherein the spacer is formed from an open-cell foam.

3. The urine diversion device of any one of claims 1-2, wherein the one or more preferential separation regions comprises one or more slits that each extend entirely through a thickness of the spacer, wherein the thickness is defined as a dimension extending between the first major surface and the second major surface.

4. The urine diversion device of claim 3, wherein the one or more slits comprises a plurality of slits that are offset from each other along a length of the spacer,wherein the length is defined as a dimension extending between the proximal-spacer end and the distal-spacer end5. The urine diversion device of claim 4, wherein the plurality of slits are parallel to each other.

6. The urine diversion device of any one of claims 3-5, wherein each of the plurality of slits extends along a dimension parallel to a width of the spacer, wherein the width of the spacer defined as a dimension that (i) extends between the first lateral side and the second lateral side and (ii) is perpendicular to the length and the thickness of the spacer.

7. The urine diversion device according to any one of claims 1-6, wherein the one or more preferential separation regions comprise one or more apertures each having a shape selected from a group consisting of: a circle, an oval, a rectangle, a triangle, a square, a hexagon, an octagon, and a non-polygonal shape.

8. The urine diversion device of claim 1, wherein the one or more preferential separation regions comprises one or more slits that each extend partially through a thickness of the spacer, wherein the thickness is defined as a dimension extending between the first major surface and the second major surface.

9. A urine diversion device, comprising: a diversion member defining an internal cavity, wherein the diversion member comprises: a bottom wall extending between a proximal end and a distal end, wherein the bottom wall defines an opening that is configured to receive a penis of a user into the internal cavity, a top wall extending between a proximal end and a distal end, a proximal wall extending from the proximal end of the bottom wall to the top wall to define a proximal-most end of the internal cavity; an outlet for egressing urine from the internal cavity of the diversion member, wherein the diversion member is suitable to direct urine received in the internal cavity distally toward the outlet; andwherein the bottom wall comprises a first attachment member that is configured to couple the diversion member to the user, and wherein the top wall comprises a second attachment member that is configured to couple the diversion member to the user.

10. The urine diversion device of claim 9, wherein the proximal wall is formed from a material that is breathable and hydrophobic.

11. The urine diversion device of claim 10, wherein proximal wall comprises a spun bound material having a hydrophobic finish that is configured to inhibit leakage of urine out of the proximal-most end of the internal cavity.

12. The urine diversion device of any one of claims 9-11, wherein the bottom wall and the top wall are formed from a liquid impervious polymer material.

13. The urine diversion device of claim 9, wherein the diversion member further comprises a first lateral side and a second lateral side opposite the first lateral side, wherein the top wall and the bottom wall extend between the first lateral side and the second lateral side, and wherein the proximal wall extends entirely between the first lateral side and the second lateral side.

14. The urine diversion device of claim 9, wherein the proximal wall is welded to the top wall.

15. The urine diversion device of claim 9, wherein the bottom wall further comprises a slit that extends from the opening to the proximal end of the bottom wall.

16. The urine diversion device of claim 15, wherein the proximal wall comprises a slit partially extending from the bottom wall towards the top wall.

17. The urine diversion device of claim 9, wherein the second attachment member is positioned proximally of the proximal wall of the diversion member.

18. The urine diversion device of claim 9, wherein, in a dimension extending between the bottom wall and the top wall, the proximal wall has a length that is greater than a maximum separation distance between the bottom wall and the top wall at a position of the proximal wall.

19. The urine diversion device of claim 9, further comprising at least one of a permeable layer or a wicking layer extending along the bottom wall, wherein the proximal wall is coupled to the bottom wall by the at least one of the permeable layer or the wicking layer.

20. The urine diversion device of claim 9, wherein the first attachment member comprises an adhesive extending around the opening defined by the bottom wall.

21. A urine diversion device, comprising: a diversion member extending from a proximal end to a distal end, wherein a bottom wall of the diversion member comprises an opening that provides access to an internal cavity of the diversion member, one or more attachment members configured to couple the diversion member to a user; an outlet for egressing urine from the internal cavity of the diversion member; and a hydrophobic layer in the internal cavity of the diversion member, wherein the hydrophobic layer is configured to move urine distally toward the outlet.

22. The urine diversion device of claim 21, wherein the hydrophobic layer comprises a nylon material having a hydrophobic coating.

23. The urine diversion device of any one of claims 21-22, wherein the hydrophobic layer extends entirely from the proximal end of the diversion member to the distal end of the diversion member.

24. The urine diversion device of any one of claims 21-23, further comprising a spacer enclosed by the hydrophobic layer in the internal cavity, wherein the spacer is configured to maintain a penis in an elevated position above a bottom wall of the diversion member.

25. The urine diversion device of any one of claims 21-24, wherein the one or more attachment members comprises a first attachment member coupled to the bottom wall, wherein the first attachment member comprises an adhesive that extends along a proximal portion of the bottom wall.

26. The urine diversion device of claim 25, wherein the adhesive of the first attachment member comprises a plurality of adhesive portions that are separated from each other by a plurality of gaps.

27. The urine diversion device of any one claims 25-26, wherein the one or more attachment members further comprises a second attachment member coupled to a top wall of the diversion member, wherein the second attachment member comprises an adhesive having a crescent shape.

28. A urine diversion device, comprising: a diversion member comprising a top wall and a bottom wall that extend between a proximal end and a distal end, wherein the top wall is coupled to the bottom wall at a first lateral side and a second lateral side of the diversion member, wherein the diversion member comprises an opening extending through the bottom wall and providing access to an internal cavity of the diversion member, one or more attachment members configured to couple the diversion member to a user; and an outlet for egressing urine from the internal cavity of the diversion member, wherein, along a direction from the proximal end toward the distal end, a width of the diversion member (i) increases outwardly away from a center axis of the diversion member along a proximal portion extending from the proximal end to a corner portion at the first lateral side and a corner portion at the second lateral side, and (ii) decreases inwardly toward the center axis from the corner portions to the distal end, and wherein the diversion member is configured to direct urine along one of the first lateral side or the second lateral side toward the corner portion at the one of the first lateral side or the second lateral side when the user is laying on their side with the diversion member coupled to the user.

29. The urine diversion device of claim 28, wherein the corner portion at the first lateral side and the corner portion at the second lateral side are located closer to the distal end of the diversion member than the proximal end of the diversion member.

30. The urine diversion device of any one claims 28-29, further comprising a suction tube (i) in the internal cavity of the diversion member, and (ii) in fluid communication with a port of the outlet, wherein he suction tube is configured to direct urine from the comer portion at the first lateral side and the corner portion at the second lateral side to the port of the outlet.

31. The urine diversion device of claim 30, wherein the suction tube comprises a first section and a second section that extend on opposing sides of the port toward the corner portion at the first lateral side and the corner portion at the second lateral side, wherein the first section comprises a first aperture at the comer portion on the first lateral side, and the second section comprises a second aperture at the corner portion on the second lateral side.

32. The urine diversion device of claim 31, wherein the suction tube further comprises a third aperture between the first section and the second section, wherein he third aperture is configured to receive urine that is distal of the first aperture and the second aperture into the port.

33. The urine diversion device of any one of claims 30-32, wherein the suction tube has an inner diameter that is greater than an inner diameter of the port.

34. The urine diversion device of any one of claims 28-33, further comprising a first spacer and a second spacer in the internal cavity of the diversion member, wherein the first spacer extends along the first lateral side and the second spacer extends along the second lateral side such that a gap is defined between the first spacer and the second spacer.

35. A urine diversion device, comprising: a diversion member extending from a proximal end to a distal end, wherein a bottom wall of the diversion member comprises an opening that provides access to an internal cavityof the diversion member, an outlet for egressing urine from the internal cavity of the diversion member, wherein the diversion member is suitable to direct urine toward the outlet; and a first attachment member rotatably coupled to the bottom wall of the diversion member, wherein the first attachment member comprises: a backing member having a first side, a second side, and an aperture extending through the first side and the second side, wherein the first side comprises an adhesive that is configured to couple to a skin of a user, a protrusion on one of the second side of the backing member or the bottom wall of the diversion member; and a track structure on another one of the second side of the backing member or the bottom wall of the diversion member, wherein the track structure is coupled to the protrusion such that (i) the track structure constrains movement of the protrusion in a direction extending from the first side toward the second side and (ii) permits circumferential movement of the protrusion about the aperture of the backing member and the opening of the diversion member.

36. The urine diversion device of claim 35, wherein the protrusion is coupled to the bottom wall, and the track structure is coupled to the second side of the backing member.

37. The urine diversion device of any one of claims 35-36, wherein the track structure comprises a channel defined by a plurality of guide walls.

38. The urine diversion device of claim 37, wherein the protrusion has a size and a shape that permits the protrusion to move within the channel while the plurality of guide walls inhibit the protrusion from moving out of the channel.

39. The urine diversion device of any one of claims 37-38, wherein the channel of the track structure is curved, wherein the protrusion has a curved shape, and wherein a radius of curvature of the protrusion generally corresponds to a radius of curvature of the channel to provide for movement of the protrusion in and along the channel of the track structure.

40. The urine diversion device of any one of claims 37-39, wherein the plurality of guide walls comprise a stop at opposing ends of the channel to limit an extent of movement of the protrusion along the track structure and prevent the protrusion from moving out of the ends of the channel.

41. The urine diversion device of any one of claims 35-40, wherein the track structure extends around at least half of a circumference of the opening.

42. A urine diversion device, comprising: a waistband configured to be worn around a waist of a user; a diversion member coupled to the waistband, wherein the diversion member defines an internal cavity, wherein the diversion member comprises an opening, wherein the diversion member is configured to receive a penis of a user in the internal cavity through the opening, wherein the diversion member comprises an outlet that is configured for egressing urine from the diversion member; a leg strap configured to be worm around a leg of the user; a secondary fluid reservoir coupled to the leg strap, wherein an inlet of the secondary fluid reservoir is coupled to the outlet of the diversion member such that the urine received in the internal cavity of the diversion member flows to the secondary fluid reservoir, wherein the secondary fluid reservoir comprises a secondary outlet that is configured to drain the secondary fluid reservoir.

43. The urine diversion device of claim 42, further comprising a tube coupling the outlet of the diversion member to the inlet of the secondary fluid reservoir.

44. The urine diversion device of any one of claims 42-43, wherein the leg strap has a height that is equal to or greater than a height of the secondary fluid reservoir.

45. The urine diversion device of any one of claims 42-44, wherein the waistband comprises one or more fasteners that are configured to adjust a size of a circumference of the waistband.

46. The urine diversion device of any one of claims 42-45, wherein the leg strap comprises one or more fasteners that are configured to adjust a size of a circumference of the leg strap.

47. The urine diversion device of any one of claims 42-46, wherein at least one of the waistband and the leg strap are formed from an elastic material.

48. A urine diversion device, comprising: a wearable garment comprising at least one bottom selected from a group consisting of: a pair of underwear, a pair of pants, and a pair of shorts; a diversion member defining an internal cavity, wherein the diversion member comprises an opening, wherein the diversion member is configured to receive a penis of a user in the internal cavity through the opening, wherein the diversion member comprises an outlet that is configured for egressing urine from the diversion member; an attachment member coupled to the diversion member, wherein the attachment member is configured to couple the diversion member to the user, wherein the diversion member and the attachment member are configured to be between the wearable garment and a skin of the user when the attachment member couples the diversion member to the user; and a secondary fluid reservoir coupled to the outlet of the diversion member such that the urine received in the internal cavity of the diversion member flows to the secondary fluid reservoir, wherein the secondary fluid reservoir is coupled to wearable garment, wherein the secondary fluid reservoir comprises a secondary outlet that is configured to drain the secondary fluid reservoir.

49. The urine diversion device of claim 48, wherein the wearable garment comprises: a first coupling between a front side and a back side of the wearable garment; and a second coupling between the front side and the back side of the wearable garment.

50. The urine diversion device of claim 49, wherein the first coupling is on a first lateral side of the wearable garment and the second coupling is on a second lateral side of the wearable garment.

51. The urine diversion device of claim 50, wherein the first coupling comprises a first outseam formed from a hook-and-loop material and the second coupling comprises a second outseam formed from the hook-and-loop material.

52. The urine diversion device of any one of claims 48-51, wherein the secondary fluid reservoir is coupled to a leg portion of the wearable garment.

53. The urine diversion device of any one of claims 48-52, wherein the secondary fluid reservoir is disposed in a pocket of the wearable garment.

54. The urine diversion device of any one of claims 48-53, wherein the diversion member is coupled to a crotch portion of the wearable garment.

55. The urine diversion device of any one of claims 48-54, wherein the secondary outlet comprises a port that is configured to couple to a vacuum source.

56. The urine diversion device of any of claims 1-55, further comprising a urine sensor that is configured to determine information relating to urine in the diversion member.

57. The urine diversion device of claim 56, wherein the urine sensor is coupled to a wall of the diversion member.

58. The urine diversion device of any one of claims 56-57, wherein the urine sensor comprises one or more sensors selected from a group consisting of a pH sensor, a turbidity sensor, a colorimetric sensor, a spectrometer, an immunoassay, and an enzyme- linked immunosorbent assay (ELISA).

59. A system, comprising: a urine diversion device comprising: a diversion member defining an internal cavity, wherein the diversion member comprises an opening, wherein the diversion member is configured to receive a penis of a user in the internal cavity through the opening, wherein the diversion member comprises an outlet that is configured foregressing urine from the diversion member, and an attachment member coupled to the diversion member, wherein the attachment member is configured to couple the diversion member to the user, a waste collection reservoir coupled to the outlet of the diversion member by a drain tube; and a hand-operated pump coupled to the waste collection reservoir, wherein the handoperated pump is manually operable to apply suction to at least the drain tube to move fluid from the outlet of the diversion member along the drain tube to the waste collection reservoir.

60. The system of claim 59, further comprising a one-way valve coupling the drain tube to the outlet of the diversion member.

61. The system of claim 60, wherein the one-way valve is actuatable between an open state and a closed state, wherein, when the one-way valve is in the closed state, the fluid is prevented from flowing from the outlet to the drain tube and prevented from flowing from the drain tube to the outlet, and wherein, when the one-way valve is in the open state, the fluid is permitted to flow from the outlet to the drain tube and prevented from flowing from the drain tube to the outlet.

62. The system of any one of claims 60-61, wherein the one-way valve comprises a knob that is movable to actuate the one-way valve between the open state and the closed state.

63. The system of any one of claims 59-62, wherein the hand-operated pump includes a suction bulb.

64. The system of any one of claims 59-63, wherein the diversion member comprises a plurality of baffles.

65. The system of claim 64, wherein the plurality of baffles define a tortious pathway between a proximal end and a distal end of the diversion member.

66. The system of any one of claims 59-65, wherein the waste collection reservoir comprises a rigid canister.

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