Devices, systems, and methods for urine diversion

Abstract

In an example, a urine diversion device includes a liquid-impermeable backing, a user interface coupled to the liquid-impermeable backing, a fluid manifold between the liquid-impermeable backing and the user interface, an internal cavity between (i) the fluid manifold and (ii) the user interface or the liquid-impermeable backing, and a fluid inlet that is configured to receive a fluid through at least the user interface into the internal cavity. The fluid manifold includes a first aperture in fluid communication with the internal cavity, a second aperture that is coupled to a fluid outlet, and one or more conduits that extend from the first aperture to the second aperture. Responsive to a vacuum pressure applied to the fluid outlet, the fluid manifold is configured to evacuate the fluid from the internal cavity, through the first aperture, along the one or more conduits, and through second aperture to the fluid outlet.

Description

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

[0001] The present application claims the benefit of priority of U.S. Provisional Application No. 63 / 700,511, filed September 27, 2024, U.S. Provisional Application No. 63 / 672,435 filed July 17, 2024, U.S. Provisional Application No. 63 / 566,364 filed March 17, 2024, U.S. Provisional Application No. 63 / 557,016, filed February 23, 2024, the contents of which are hereby incorporated by reference in their entirety.FIELD

[0002] The present disclosure generally relates to devices, systems, and methods for urine management and, in particular, to devices, systems, and methods for diverting urine discharged from the body of a user to a waste receptacle.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 diversion 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 diversion have been developed, which include a urine collection device configured to be placed external to, but in contact with the body for diverting the urine to a fluid receptacle. However, some of 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, patient discomfort, and / or incomplete urine diversion.SUMMARY

[0006] In an example, a urine diversion device includes a backing having a proximal surface and a distal surface. The backing comprises a plurality of inner walls extending from the proximal surface of the backing. The urine diversion device also includes a user interface coupled to the backing. The user interface is proximal of the backing. The urine diversion device further includes an internal cavity between the backing and the user interface. The user interface includes a fluid inlet that is configured to receive a fluid into the internal cavity. The plurality of inner walls define a plurality of channels in the internal cavity. The urine diversion device also includes a fluid outlet configured to egress the fluid out of the internal cavity responsive to a vacuum pressure applied to the fluid outlet. The fluid outlet is fluidly coupled to the plurality of channels such that the vacuum pressure applied to the fluid outlet propagates into the plurality of channels.

[0007] In another example, a urine diversion device includes a backing having a proximal side and a distal side, a vacuum port coupled to the distal side of the backing, a wicking material coupled to the proximal side of the backing, and a rim coupled to the backing and extending around the wicking material. The wicking material is configured to wick a fluid in a distal direction towards the backing. The backing includes a plurality of vacuum apertures on the proximal side that are configured to evacuate the fluid from the wicking material out of the vacuum port.

[0008] In another example, a urine diversion device includes a vacuum port comprising a proximal flange, a distal flange, a shaft portion extending between the proximal flange and the distal flange, and a connector extending distally from the distal flange. The urine diversion device also includes a wicking material including a proximal side, a distal side, and an aperture extending through the proximal side and the distal side. The urine diversion device further includes an adhesive sheet having a proximal side, a distal side, and an aperture extending through the proximal side and the distal side. The adhesive sheet includes anadhesive on the proximal side of the adhesive sheet. The shaft portion of the vacuum port extends through the aperture of the wicking material and the aperture of the adhesive sheet. The adhesive sheet and the wicking material are sandwiched between the proximal flange and the distal flange of the vacuum port.

[0009] In another example, a urine diversion device includes a vacuum port comprising a proximal flange, a distal flange, a shaft portion extending between the proximal flange and the distal flange, and a connector extending distally from the distal flange. The urine diversion device also includes a wicking material including a proximal side and a distal side, wherein the wicking material extends over the proximal flange of the vacuum port. The urine diversion device also includes an adhesive sheet having a proximal side, a distal side, and an aperture extending through the proximal side and the distal side. The adhesive sheet includes an adhesive on the proximal side of the adhesive sheet. The wicking material is coupled to the adhesive sheet by the adhesive on the proximal side of the adhesive sheet. The adhesive sheet is coupled to the vacuum port by the shaft portion of the vacuum port extending through the aperture of the adhesive sheet and the adhesive sheet sandwiched between the proximal flange and the distal flange of the vacuum port.

[0010] In another example, a urine diversion device includes a liquid-impermeable backing, a user interface coupled to the liquid-impermeable backing, a fluid manifold between the liquid-impermeable backing and the user interface, an internal cavity between (i) the fluid manifold and (ii) the user interface or the liquid-impermeable backing, and a fluid inlet that is configured to receive a fluid through at least the user interface into the internal cavity. The fluid manifold includes a first aperture in fluid communication with the internal cavity, a second aperture that is coupled to a fluid outlet, and one or more conduits that extend from the first aperture to the second aperture. Responsive to a vacuum pressure applied to the fluid outlet, the fluid manifold is configured to evacuate the fluid from the internal cavity, through the first aperture, along the one or more conduits, and through second aperture to the fluid outlet.

[0011] In another example, a urine diversion device includes a liquid-impermeable backing and a user interface coupled to the liquid-impermeable backing. The user interface is proximal of the liquid-impermeable backing. The urine diversion device also includes a fluid manifold between the liquid-impermeable backing and the user interface, an internal cavity between the fluid manifold and the liquid-impermeable backing, and a fluid inlet that is configured to receive a fluid through at least the user interface into the internal cavity. The fluidmanifold includes a first aperture in fluid communication with the internal cavity, a second aperture that is coupled to a fluid outlet, and one or more conduits that extend from the first aperture to the second aperture. Responsive to a vacuum pressure applied to the fluid outlet, the fluid manifold is configured to evacuate the fluid from the internal cavity, through the first aperture, along the one or more conduits, and through second aperture to the fluid outlet.

[0012] In another example, a urine diversion device includes a liquid-impermeable backing and a user interface coupled to the liquid-impermeable backing. The user interface is proximal of the liquid-impermeable backing. The urine diversion device also includes a fluid manifold between the liquid-impermeable backing and the user interface, an internal cavity between the fluid manifold and the user interface, and a fluid inlet that is configured to receive a fluid through at least the user interface into the internal cavity. The fluid manifold includes a first aperture in fluid communication with the internal cavity, a second aperture that is coupled to a fluid outlet, and one or more conduits that extend from the first aperture to the second aperture. Responsive to a vacuum pressure applied to the fluid outlet, the fluid manifold is configured to evacuate the fluid from the internal cavity, through the first aperture, along the one or more conduits, and through second aperture to the fluid outlet.

[0013] 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

[0014] 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:

[0015] Figure 1 depicts a simplified diagram of a system 100 for diverting urine is depicted according to an example, according to an example.

[0016] Figure 2 depicts a simplified block diagram of a urine diversion device, according to an example.

[0017] Figure 3 A depicts a proximal side of the urine diversion device, according to an example.

[0018] Figure 3B depicts a distal side of the urine diversion device shown in Figure 3 A, according to an example.

[0019] Figure 3C depicts an exploded view of the urine diversion device shown in Figure 3 A, according to an example.

[0020] Figure 3D depicts a proximal surface of a backing for the urine diversion device shown in Figures 3A-3C, according to an example.

[0021] Figure 3E depicts a distal surface of a backing for the urine diversion device shown in Figures 3A-3C, according to an example.

[0022] Figure 3F depicts a cross-sectional view of the backing shown in Figures 3D- 3E, according to an example.

[0023] Figure 4A depicts a proximal side of the urine diversion device, according to an example.

[0024] Figure 4B depicts a distal side of the urine diversion device shown in Figure 4A, according to an example.

[0025] Figure 4C depicts a proximal surface of a backing for the urine diversion device shown in Figures 4A-4B, according to an example.

[0026] Figure 4D depicts a cross-sectional view of the backing shown in Figure 4C, according to an example.

[0027] Figure 4E depicts another cross-sectional view of the backing shown in Figure 4C, according to an example.

[0028] Figure 5A depicts a proximal side of the urine diversion device, according to an example.

[0029] Figure 5B depicts a distal side of the urine diversion device shown in Figure 5A, according to an example.

[0030] Figure 6A depicts a proximal side of the urine diversion device, according to an example.

[0031] Figure 6B depicts a distal side of the urine diversion device shown in Figure 6A, according to an example.

[0032] Figure 6C depicts a backing of the urine diversion device shown in Figure 6A,according to an example.

[0033] Figure 7 depicts a simplified block diagram of a urine diversion device, according to another example.

[0034] Figure 8A depicts a proximal side of the urine diversion device, according to an example.

[0035] Figure 8B depicts a distal side of the urine diversion device shown in Figure 8A, according to an example.

[0036] Figure 8C depicts a partially exploded view of the urine diversion device shown in Figures 8A-8B, according to an example.

[0037] Figure 9A depicts a proximal side of the urine diversion device, according to an example.

[0038] Figure 9B depicts a distal side of the urine diversion device shown in Figure 9A, according to an example

[0039] Figure 10A depicts a distal side of the urine diversion device, according to an example.

[0040] Figure 10B depicts a cross-sectional view of the urine diversion device shown in Figure 10 A, according to an example

[0041] Figure 11A depicts a proximal side of the urine diversion device, according to an example.

[0042] Figure 1 IB depicts a distal side of the urine diversion device shown in Figure 11 A, according to an example.

[0043] Figure 12A depicts an attachment member of a urine diversion device at a first position on a drain tube, according to an example.

[0044] Figure 12B depicts the attachment member of Figure 12A at a second position on the drain tube, according to the example.

[0045] Figure 12C depicts the attachment member of Figure 12A decoupled from the drain tube, according to the example.

[0046] Figure 12D depicts a side view of the attachment member of Figure 12A coupled to the drain tube, according to the example.

[0047] Figure 13 A depicts a distal side of a urine diversion device including the attachment member of Figure 12A, according to an example.

[0048] Figure 13B depicts a proximal side of a urine diversion device including the attachment member of Figure 12A, according to an example.

[0049] Figure 14 depicts a simplified diagram of a urine diversion device, according to another example.

[0050] Figure 15A depicts a perspective view of an implementation of the urine diversion device shown in Figure 14, according to an example.

[0051] Figure 15B depicts a proximal side view of the urine diversion device shown in Figure 15 A, according to an example.

[0052] Figure 15C depicts an exploded view of the urine diversion device shown in Figure 15 A, according to an example.

[0053] Figure 15D depicts a cross-sectional view of the urine diversion device through a longitudinal axis 1560 shown in Figure 15B, according to an example.

[0054] Figure 15E depicts an exploded view of a fluid manifold and a fluid outlet for the urine diversion device shown in Figures 15A-15D, according to an example.

[0055] Figure 15F depicts a perspective view of the fluid manifold and a fluid outlet shown in Figure 15E, according to an example.

[0056] Figure 16 depicts a simplified diagram of a urine diversion device, according to another example.

[0057] Figure 17A depicts a proximal side view of an implementation of the urine diversion device shown in Figure 16, according to an example.

[0058] Figure 17B depicts a distal side view of the urine diversion device shown in Figure 17A, according to an example.

[0059] Figure 17C depicts an exploded view of the urine diversion device shown in Figure 17A, according to an example.

[0060] Figure 17D depicts an exploded view of a fluid manifold and a fluid outlet for the urine diversion device shown in Figures 17A-17C, according to an example.

[0061] Figure 17E depicts an assembly view of the fluid manifold and the fluid outletfor the urine diversion device shown in Figures 17A-17C, according to an example.

[0062] Figure 18A depicts an exploded view of a fluid manifold and a fluid outlet for the urine diversion device shown in Figures 17A-17C, according to another example.

[0063] Figure 18B depicts a fluid manifold and a shape retaining element for the urine diversion device shown in Figures 17A-17C, according to another example.

[0064] Figure 19 depicts an exploded view of a fluid manifold and a fluid outlet for the urine diversion device shown in Figures 17A-17C, according to another example.

[0065] Figure 20A shows a proximal side view of an implementation of the urine diversion device shown in Figure 16, according to another example.

[0066] Figure 20B shows a lateral side view of an inferior portion of the urine diversion device shown in Figure 20, according to an example.

[0067] Figure 20C depicts a cross-sectional view of the urine diversion device shown in Figure 20, according to an example.

[0068] Figure 21A shows a first perspective view of the urine diversion device, according to an example.

[0069] Figure 2 IB shows a second perspective view of the urine diversion device, according to an example.

[0070] Figure 21C shows a proximal side view of the urine diversion device, according to an example.

[0071] Figure 21D shows a distal side view of the urine diversion device, according to an example.

[0072] Figure 2 IE shows an exploded view of the urine diversion device, according to an example.

[0073] Figure 2 IF shows a cross-sectional view of the urine diversion device through a longitudinal axis 2160 shown in Figure 21C, according to an example.

[0074] Figure 21G shows an enlarged view of a portion of the urine diversion device shown in Figure 2 IF, according to an example.

[0075] Figure 21H depicts a partial assembly view of the urine diversion device, according to an example.

[0076] Figure 211 depicts a first perspective view of a suction port of the urine diversion device shown in Figure 21 A, according to an example.

[0077] Figure 21 J depicts a second perspective view of the suction port shown in Figure 211, according to an example.

[0078] Figure 2 IK depicts a cross-sectional view of the suction port shown in Figure 211 taken through a longitudinal axis, according to an example.

[0079] Figure 22A depicts the urine diversion device of Figure 21A with a visual indicator on a liquid-impermeable backing, according to an example.

[0080] Figure 22B depicts the urine diversion device of Figure 21A with a visual indicator on a liquid-impermeable backing, according to another example.

[0081] Figure 22C depicts the urine diversion device of Figure 21A with a visual indicator on a liquid-impermeable backing, according to another example.

[0082] Figure 22D depicts the urine diversion device of Figure 21A with a visual indicator on a liquid-impermeable backing, according to another example.

[0083] Figure 22E depicts the urine diversion device of Figure 21A with a visual indicator on a user interface, according to another example.

[0084] Figure 23A depicts the urine diversion device of Figure 21A with perforations on a user interface, according to an example.

[0085] Figure 23B depicts the urine diversion device of Figure 21A with a visual indicator and perforations on a user interface, according to another example.

[0086] Figure 23C depicts the urine diversion device of Figure 21A with a visual indicator and perforations on a user interface, according to another example.

[0087] Figure 23D depicts the urine diversion device of Figure 21A with a visual indicator and perforations on a user interface, according to another example.

[0088] Figure 23E depicts the urine diversion device of Figure 21A with a visual indicator and perforations on a user interface, according to another example.

[0089] Figure 24A depicts the urine diversion device of Figure 21 A with an orientation indicator on a suction port, according to an example.

[0090] Figure 24B depicts the urine diversion device of Figure 21 A with an orientationindicator on a suction port, according to another example.

[0091] Figure 24C depicts the urine diversion device of Figure 21 A with an orientation indicator on a suction port, according to another example.

[0092] Figure 25 A depicts a distal side of the fluid manifold of a urine diversion device, according to another example.

[0093] Figure 25B depicts the proximal side of the fluid manifold shown in Figure 25 A, according to the example.

[0094] Figure 26 depicts a partial view of a proximal manifold portion of a urine diversion device, according to an example.

[0095] Figure 27A depicts a first perspective view of a suction port of a urine diversion device, according to an example.

[0096] Figure 27B depicts a second perspective view of the suction port shown in Figure 27A, according to an example.

[0097] Figure 27C depicts a cross-sectional view of the suction port shown in Figure 27A taken through a longitudinal axis, according to an example.

[0098] Figure 28A depicts a perspective view of a urine diversion device, according to another example.

[0099] Figure 28B depicts a perspective view of a urine diversion device, according to another example.

[0100] Figure 29A depicts a perspective view of a urine diversion device, according to another example.

[0101] Figure 29B depicts a perspective view of a urine diversion device, according to another example.

[0102] Figure 30 depicts a liquid-impermeable backing a urine diversion device, according to another example.

[0103] Figure 31 A depicts a proximal side view of a urine diversion device, according to an example

[0104] Figure 3 IB depicts a proximal side view of the urine diversion device shown in Figure 31 A with a user interface and a spacer omitted, according to an example.

[0105] Figure 31C depicts a cross-sectional view of the urine diversion device shown in Figure 31 A, according to an example.

[0106] Figure 3 ID depicts a perspective view of a reinforcing member of the urine diversion device shown in Figure 31 A, according to an example.

[0107] Figure 32A depicts a proximal side view of a fluid manifold of a urine diversion device, according to another example.

[0108] Figure 32B depicts a cross-sectional view at a channel of the urine diversion device shown in Figure 32A, according to an example.

[0109] Figure 33A depicts a proximal side view of a distal manifold portion, including stress-relief sections, of a urine diversion device, according to an example.

[0110] Figure 33B depicts a side view of a distal manifold portion of the urine diversion device shown in Figure 33A, according to an example.

[0111] Figure 33C depicts a proximal side view of the proximal manifold portion for the urine diversion device shown in Figure 33A, according to an example.

[0112] Figure 34A depicts a distal side of a fluid manifold for a urine diversion device, according to another example.

[0113] Figure 34B depicts a proximal side of a fluid manifold for the urine diversion device of Figure 34A, according to another example.

[0114] Figure 35 depicts a fluid manifold for a urine diversion device, according to another example.

[0115] Figure 36A depicts a proximal side of a urine diversion device, according to another example.

[0116] Figure 36B depicts the distal side of the urine diversion device shown in Figure 36 A, according to the example.

[0117] Figure 37A depicts an outer cover for a urine diversion device, according to an example.

[0118] Figure 37B depicts a first step for coupling the outer cover shown in Figure 37A to the urine diversion device 2110 shown in Figure 37 A, according to an example.

[0119] Figure 37C depicts a second step for coupling the outer cover shown in Figure37A to the urine diversion device 2110 shown in Figure 37A, according to an example.

[0120] Figure 37D depicts a third step for coupling the outer cover shown in Figure 37A to the urine diversion device 2110 shown in Figure 37A, according to an example.

[0121] Figure 38A depicts a first view of an attachment member in a first state, according to another example.

[0122] Figure 38B depicts a second view of the attachment member shown in Figure 38A in the first state, according to the example.

[0123] Figure 38C depicts the attachment member shown in Figure 38A in the first state on a whip tube, according to an example.

[0124] Figure 38D depicts the attachment member shown in Figure 38A in a second state on the whip tube shown in Figure 38C, according to an example.

[0125] Figure 39A depicts a first step for operating an attachment member of a urine diversion device, according to an example.

[0126] Figure 39B depicts a second step for operating the attachment member of Figure 39 A, according to an example.

[0127] Figure 39C depicts a third step for operating or operating the attachment member of Figure 39A, according to an example.

[0128] Figure 40A depicts a clip coupled to an attachment member, according to another example.

[0129] Figure 40B depicts a clip coupled to an attachment member, according to another example.

[0130] Figure 40C depicts a clip coupled to an attachment member, according to another example.

[0131] Figure 40D depicts a clip coupled to an attachment member, according to another example.

[0132] Figure 40E depicts a clip coupled to an attachment member, according to another example.

[0133] Figure 41A shows a proximal side view of a urine diversion device, according to another example.

[0134] Figure 41B shows a distal side view of the urine diversion device of Figure 41 A, according to an example.

[0135] Figure 41C shows an exploded view of the urine diversion device of Figure 41 A, according to an example.

[0136] Figure 42A depicts a superior end view of a spacer that can be used with a urine diversion device, according to an example.

[0137] Figure 42B depicts a proximal side view of the spacer shown in Figure 42A, according to an example.

[0138] Figure 42C depicts a lateral side view of the spacer shown in Figure 42A, according to an example.

[0139] Figure 43 A depicts a superior end view of a spacer that can be used with a urine diversion device, according to an example.

[0140] Figure 43B depicts a proximal side view of the spacer shown in Figure 42A, according to an example.

[0141] Figure 43C depicts a lateral side view of the spacer shown in Figure 42A, according to an example.

[0142] Figure 44A depicts a first perspective view of a urine diversion device, according to an example.

[0143] Figure 44B depicts a second perspective view of the urine diversion device shown in Figure 44A, according to an example.

[0144] Figure 44C depicts a partially exploded view of the urine diversion device shown in Figure 44A, according to an example.

[0145] Figure 44D depicts a perspective view of the urine diversion device shown in Figure 44A with a proximal interface layer 2126A omitted, according to an example.

[0146] Figure 44E depicts a view of a proximal side of the urine diversion device shown in Figure 44A with the proximal interface layer omitted, according to an example.

[0147] Figure 44F depicts a fluid manifold of the urine diversion device shown in Figure 44A, according to the example.

[0148] Figure 45 depicts an implementation of a fluid manifold including a plurality ofconduits, according to an example.

[0149] Figure 46 depicts an implementation of a fluid manifold including a plurality of conduits, according to another example.

[0150] Figure 47 depicts an implementation of a fluid manifold including a plurality of conduits, according to another example.

[0151] Figure 48 depicts an implementation of a fluid manifold including a plurality of conduits, according to another example.

[0152] Figure 49 depicts an implementation of the fluid manifold including a conduit, according to another example.

[0153] Figure 50 depicts an implementation of the fluid manifold including a conduit, according to another example.

[0154] Figure 51 depicts an implementation of a fluid manifold including a plurality of conduits, according to another example.

[0155] Figure 52 depicts a fluid manifold and a spacer of a urine diversion device, according to another example.

[0156] Figure 53 depicts a flowchart for a process for diverting urine, according to an example.

[0157] Figure 54 depicts a flowchart for a process for making a urine diversion device, according to an example.DETAILED DESCRIPTION

[0158] 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.

[0159] By the term “approximately” or “substantially” with reference to amounts or measurement values described herein, it is meant that the recited characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including for example,tolerances, measurement error, measurement accuracy limitations and other factors known to those of skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide.

[0160] Referring now to Figure 1, a simplified diagram of a system 100 for diverting urine is depicted according to an example. As shown in Figure 1, the system 100 can includes a urine diversion device 110, a drain tube 112, a waste collection receptacle 114, and a vacuum device 116.

[0161] The urine diversion device 110 can be configured to be receive a fluid (e.g., urine) discharged from a body of a user when positioned on the body of the user. To assist in receiving the urine from the body of the user, the urine diversion device 110 can include at least one component selected from a group of components consisting of: a liquid impermeable material and an absorbent material. Additionally, the urine diversion device 110 can include a fluid outlet 118 that is configured to egress the fluid from the urine diversion device 110 towards the waste collection receptacle 114. Example implementations of the urine diversion device 110 are described in further detail below with respect to Figures 2-1 IB.

[0162] As shown in Figure 1, a first end 112A of the drain tube 112 can be coupled to the fluid outlet 118 of the urine diversion device 110. For example, the drain tube 112 can include a thread, a Luer coupling, a bayonet coupling, and / or other feature for coupling the drain tube 112 to the fluid outlet 118. Within examples, the drain tube 112 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 112 away from the user’s body (e.g., off the side of a bed) to reduce (or prevent) the drain tube 112 from accidental pulling the urine diversion device 110 away from the user and leakage resulting from such pulling.

[0163] As described in further detail below, in some implementations, the urine diversion device 110 and the first end 112A of the drain tube 112 can be rotatably coupled to each other. This can additionally or alternatively assist in improving user comfort and / or reducing (or preventing) accidental pulling on the urine diversion device 110. However, in other implementations, the urine diversion device 110 and the drain tube 112 can be non- rotationally coupled to each other. This can help to simplify manufacturing and / or reduce a cost of manufacture.

[0164] The waste collection receptacle 114 is coupled to a second end 112B of the drain tube 112 to receive the urine from the drain tube 112. In one example, the wastecollection receptacle 114 can be a leg bag, a drainage bag, a rigid canister, or other container. In another example, the waste collection receptacle 114 can include a hanger and / or another structure for coupling the waste collection receptacle 114 to a patient support surface 120 (e.g., a bed, a wheelchair, and / or a chair) used by the user.

[0165] In some examples, the waste collection receptacle 114 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 receptacle 114 can be disposable. In other examples, the waste collection receptacle 114 can be reusable. For instance, the waste collection receptacle 114 can be configured to be sterilized after a use and reused.

[0166] The vacuum device 116 can apply a vacuum pressure to the drain tube 112 to assist in directing the urine from the fluid outlet 118 to the waste collection receptacle 114. For instance, the vacuum device 116 can include an air pump or other vacuum source, which is coupled to the waste collection receptacle 114 by an air tube 122. In this arrangement, the vacuum device 116 can be operated to apply the vacuum pressure at the urine diversion device 110 via the air tube 122, the waste collection receptacle 114, and the drain tube 112. The vacuum pressure applied at the urine diversion device 110 can assist in directing the fluid received in the urine diversion device 110 towards the waste collection receptacle 114 and away from the user.

[0167] In some examples, the vacuum device 116 can be a wall vacuum integrated into a room of a medical facility. In other examples, the vacuum device 116 can be integrated with the patient support surface 120. For instance, the vacuum device 116 can be integrated with a bed in a medical facility. In still other examples, the vacuum device 116 and the waste collection receptacle 114 can be integrated with each other. In such an example, the air tube 122 can be omitted.

[0168] Within some examples, the system 100 can also include an occlusion clip for selectively controlling the flow of urine in the drain tube 112. For instance, the occlusion clip can provide for stopping the flow of urine in the drain tube 112 to facilitate changing and / or emptying the waste collection receptacle 114.

[0169] Referring now to Figure 2, a simplified block diagram of a urine diversion device 210 is shown for an implementation of the urine diversion device 110 described above, according to some examples. As shown in Figure 2, the urine diversion device 210 includes a backing 224 and a user interface 226 coupled to the backing 224. In use, when the urinediversion device 210 is positioned on a user, the user interface 226 is configured to face towards a user and the backing 224 is configured to face away from the user. As such, the user interface 226 can be proximal of the backing 224 (e.g., on a proximal side of the backing 224). A distal surface of the backing 224 can be opposite the proximal surface of the backing 224 and face away from the user when the urine diversion device 210 is positioned on the user.

[0170] Additionally, as shown in Figure 2, the urine diversion device 210 can include an internal cavity 228 between the backing 224 and the user interface 226. The user interface 226 includes a fluid inlet 230 that is configured to receive a fluid into the internal cavity 228. In one example, the user interface 226 can include a layer of material having an aperture that defines the fluid inlet 230. In another example, the user interface 226 can include a first material that has a first permeability and a second material that has a second permeability, which is less than the first permeability. In this example, a portion of the user interface 226 including the first material can define the fluid inlet 230, and the portion of the user interface 226 including the second material can help to provide one or more additional or alternative functionalities (e.g., enhancing user comfort, assisting with securing the urine diversion device 210 to the user, and / or promoting dryness of the urine diversion device 210). In other examples, an entire proximal surface the user interface 226 can define the fluid inlet 230. For instance, an entirety of the user interface 226 can be formed from a common, permeable material that can allow the fluid to pass from the body of the user into the internal cavity 228.

[0171] In some examples, at least the portion of the user interface 226 that defines the fluid inlet 230 can be configured to draw the fluid into the internal cavity 228 (e.g., in a distal direction toward the backing 224). For instance, the user interface 226 can be formed of a material having a relatively high absorptive rate, a relatively high adsorption rate, and / or a relatively high permeation rate such that fluids such as urine can be rapidly wicked and drawn into the internal cavity 228. As one example, the user interface 226 can be made from an absorbent polyester mesh material (e.g., a jersey mesh material). As another example, the user interface 226 can be made of a blend of polyester and spandex (e.g., a. blend including approximately 90 percent polyester and approximately 10 percent spandex). In yet another example, the user interface 226 can include a fibrous material that is configured to draw the urine toward the internal cavity 228 under capillary action. In another example, the user interface 226 can be formed from a material having a total weight of approximately 4.0 ounces per square yard (plus or minus approximately 5%), a fiber that is a mechanically wicking yarn, a knit configured as a circular knit, a dimpled face, a wicking finish, and a width ofapproximately 60 inches to approximately 61 inches.

[0172] Within examples, the fluid inlet 230 can be disposed on a portion of the user interface 226 such that the fluid inlet 230 is configured to be positioned adjacent to a urethral opening of the user when the urine diversion device 210 is positioned on the user. In some examples, the user interface 226 can include the fluid inlet 230 at a central portion of the user interface 226. In some examples, the user interface 226 can include a peripheral portion that surrounds the user interface 226.

[0173] In some examples, the fluid inlet 230 can have a tear drop shape such that a superior portion of the fluid inlet 230 is smaller than an inferior portion of the fluid inlet 230. A tear drop shape can help to reduce a size of the urine diversion device 210 and / or assist in positioning the urine diversion device 210 relative to the user.

[0174] In other examples, the fluid inlet 230 can have an hour glass shape (e.g., along a center axis extending between a superior end and an inferior end of the user interface 226, the fluid inlet 230 tapers inwardly toward the center axis from the superior portion towards an intermediate portion, and tapers outwardly away from the center axis). In still other examples, the fluid inlet 230 can have any other polygonal shape (e.g., a rectangle, a square, a rhombus, and / or a triangle) or non-polygonal shape (e.g., an oval or a circle).

[0175] In some examples, the backing 224 can be liquid impermeable. This can help to inhibit or mitigate fluid leaking out of a distal side of the urine diversion device 210 when the fluid is received in the internal cavity 228 through the fluid inlet 230. In other examples, the backing 224 can include a fluid permeable material. For instance, the distal side of the backing 224 can be include the fluid permeable material to assist in mitigating water logging of the drain tube 112.

[0176] In some examples, the backing 224 can additionally or alternatively be flexible. This can allow the backing 224 to conform to a shape of an anatomy of the user when the urine diversion device 210 is positioned on the user. In other examples, the backing 224 can be formed from a substantially rigid material.

[0177] In an example, the backing 224 can be formed from an elastomer (e.g., a thermoplastic elastomer). Additionally, as examples, the backing 224 can be formed from at least one material selected from a group of materials consisting of: silicone, polyurethane, polyisoprene, polypropylene, polyvinyl chloride, and polyethylene.

[0178] In some examples, the backing 224 can be a malleable material that isconfigured to be manually shaped (e.g., under forces typically applicable by human fingers without the assistance of a machine) prior to, during, or after positioning the urine diversion device 210 on the user. For instance, the backing 224 can include one or more shape retaining elements coupled to and / or embedded in a base material of the backing 224. As examples, the one or more shape retaining elements can include at least one structure selected from a group consisting of a metal wire and a plastic material. In some examples, the one or more shape retaining elements can be configured to be made malleable responsive to an external stimulus (e.g., heat, electrical signal, pressure, and light). Forming the backing 224 of a malleable material can beneficially help to adjust a shape of the urine diversion device 210 according to a particular anatomy of a user on which the urine diversion device 210 is to be positioned.

[0179] Additionally or alternatively, in implementations in which the backing 224 is malleable and / or flexible, the urine diversion device 210 can be manufactured, shipped, and stored in a shape that is more compact (e.g., a straight shape) while allowing the urine diversion device 210 to be subsequently bent to form a curve that can help to better conform the urine diversion device 210 to the anatomy of the user.

[0180] In other examples, the backing 224 can be non-malleable. For instance, in some implementations in which the backing 224 is flexible, the backing 224 can be non- malleable to reduce costs, simplify manufacturing, and / or avoid the use of certain malleable materials (e.g., avoid metal materials). In some examples, the backing 224 can be non- malleable and substantially rigid. In such examples, the backing 224 can have a shape and / or a size that is suitable to fit most anatomies of users (e.g., a one-size fits most), and / or the backing 224 can be manufactured with a plurality of different shapes and / or a plurality of different sizes such that a user can select a shape and a size that best fits the user.

[0181] As shown in Figure 2, the urine diversion device 210 also includes a plurality of inner walls 232 that extend from the proximal surface of the backing 224 towards the user interface 226. The inner walls 232 define one or more channels 234 in the internal cavity 228. For instance, each channel 234 can be defined by a space between a respective pair of adjacent ones of the inner walls 232. Within examples, each channel 234 can be an open channel (e.g., each channel 234 can have a distal wall defined by the proximal surface of the backing 224, two opposing side walls defined by a respective pair of the inner walls 232, and no proximal wall). As described in further detail below, this can allow the one or more channels 234 to receive the fluid from the fluid inlet 230, direct air flow through the internal cavity 228, and / or apply a portion of a vacuum pressure to the user interface 226.

[0182] In some examples, the one or more channels 234 can be elongated along a longitudinal axis of the backing 224 (e.g., an axis extending between an interior end of the backing 224 and a superior end of the backing 224). For instance, each inner wall 232 can have a length that extends along the longitudinal axis, a width that extends between opposing lateral sides of the inner wall 232, and a height that extends in a proximal direction (e.g., in a direction from the proximal surface of the backing 224 towards the user interface 226). Similarly, each channel 234 can have a length that is defined by the lengths of the respective inner walls 232 that define the channel 234, a width that is defined by a distance between the respective inner walls 232 that define the channel 234, and a height that is defined by the heights of the respective inner walls 232 that define the channel 234. In examples in which the channel(s) 234 are elongated along the longitudinal axis, the lengths of the inner walls 232 and the channel(s) 234 can be greater than the heights and the widths.

[0183] In some examples, the one or more inner walls 232 and the backing 224 can be formed as a single, monolithic structure. This can help to simply a manufacturing process by obviating the need to couple the one or more inner walls 232 to the backing 224 (e.g., the proximal surface of the backing 224). Additionally or alternatively, forming the one or more inner walls and the backing 224 as a single, monolithic structure can help to mitigate gaps between the inner wall(s) 232 and the proximal surface of the backing 224. However, in other examples, the one or more inner walls 232 can be formed separately from the backing 224, and then the one or more inner walls 232 can be coupled to the proximal surface of the backing 224. As examples, the one or more inner walls 232 can be coupled to the proximal surface of the backing 224 by at least one coupling selected from a group consisting of: an adhesive coupling, an ultrasonic weld coupling, a radiofrequency weld, a hot-plate weld, a solvent weld, overmolding, insert molding, hot bar or heat sealing, impulse welding, dielectric welding, induction welding.

[0184] Within examples, at least one of the one or more channels 234 is configured to receive the fluid that pass through the fluid inlet 230 into the internal cavity 228. For instance, the one or more or more channels 234 can include a main channel positioned below (e.g., distal of) the fluid inlet 230 so that the main channel can receive the fluid from the fluid inlet 230. In some examples, the main channel can have a size and / or a shape that is substantially similar or identical to a size and / or a shape of the fluid inlet 230. This can help to direct substantially all of the fluid received at the fluid inlet 230 into the main channel. In other examples, the main channel can have a size that is greater than a size of the fluid inlet 230. This can further enhancedirecting the fluid from the fluid inlet 230 to the main channel.

[0185] In some examples, the one or more channels 234 can also include one or more additional channels that extend on opposing lateral sides of the main channel. As described in further detail below, the one or more additional channels can enhance air flow in the internal cavity 228 to, for example, help dry out the urine diversion device 210 and / or improve user comfort in some implementations. Within examples, the urine diversion device 210 can include one channel 234, two channels 234, three channels 234, four channels 234, five channels 234, or more than 5 channels 234.

[0186] In some examples, at least one of the channel(s) 234 can have different dimensions than another one of the channel(s) 234. For instance, in some implementations, the main channel can have a volume that is greater than a volume of the one or more additional channels. This can help to provide a greater portion of the internal cavity 228 for receiving and diverting the fluid as compared to a portion of the internal cavity 228 that is used for secondary functions (e.g., drying and / or comfort).

[0187] As shown in Figure 2, the urine diversion device 210 also includes a fluid outlet 236 configured to egress the fluid out of the internal cavity 228 responsive to a vacuum pressure applied to the fluid outlet 236 (e.g., by the vacuum device 116 as described above with respect to Figure 1). The fluid outlet 236 is fluidly coupled to the one or more channels 234 such that the vacuum pressure applied to the fluid outlet 236 propagates into the one or more channels 234. In this way, the fluid can be evacuated out of the one or more channels 234 through the fluid outlet 236 by the vacuum pressure that propagates from the fluid outlet 236 into the one or more channels 234, and / or air flow can be directed through the internal cavity 228 to assist with drying and / or user comfort.

[0188] In some examples, the fluid outlet 236 can be integrally formed with the backing 224 as a single, monolithic structure. For instance, the fluid outlet 236 can include an aperture at the superior end of the backing 224, an inferior end of the backing 224, and / or an intermediate point between the superior end and the inferior end of the backing 224. In other examples, the fluid outlet 236 can be an aperture between the backing 224 and the user interface 226 at a superior end of the internal cavity 228 and / or an inferior end of the internal cavity 228.

[0189] In some examples, the fluid outlet 236 can also include a suction port 238 that is configured to couple to the drain tube 112. For instance, the suction port 238 can be formed of a substantially rigid material that can help to couple the fluid outlet 236 to the drain tube112. As examples, the suction port 238 can include at least one fitting selected from a group consisting of a luer coupling, a push-on connector, a threaded connector, and a bayonet connector. In another example, the suction port 238 can include a tapered end portion for coupling with the drain tube 112 (e.g., a distal end of the suction port 238 can have an outer diameter that decreases along a distal direction). Given that drain tubes 112 may have different sizes (e.g., depending on the make and / or model of the vacuum device 116), the tapered end portion of the suction port 238 can help to more universally couple the suction port 238 to a plurality of differently sized drain tubes 112.

[0190] In some examples, the suction port 238 can be fixedly coupled to the fluid outlet 236 such that the suction port 238 is not rotatable relative to the backing 224. This can simplify a manufacturing process and / or reduce a cost of manufacture. In such examples, the suction port 283 can have a single configuration and orientation relative to the backing 224.

[0191] In other examples, the suction port 238 can be rotatably coupled to the backing 224 such that the suction port 238 can rotate about an axis relative to the backing 224. For instance, the suction port 238 can include a joint that is configured to allow the suction port 238 to rotate about the axis. In this arrangement, rotation of the suction port 238 can help to inhibit twisting or kinking of the drain tube 112 and / or improve user comfort.

[0192] In some implementations, the suction port 238 is freely rotatable by more than 360 degrees relative to the backing 224. This can help mitigate twisting and kinking in all rotational positions of the drain tube 112 relative to the backing 224. However, in other implementations, the suction port 238 can be rotatable by less than 360 degrees relative to the backing 224. This may help to constrain the drain tube 112 to a particular range of positions relative to the backing 224, which may beneficially help to maintain the drain tube 112 at a position extending away from the user.

[0193] In some examples, the fluid outlet 236 can also include a whip tube 240 that extends between (i) the aperture in backing 224 and / or the aperture between the backing 224 and the user interface 226, and (ii) the suction port 238. The whip tube 240 can help to extend the suction port 238 farther away from the backing 224 and the user interface 226 than other implementations in which the suction port 238 is directly coupled to the backing 224 and / or the user interface 226. In other examples, the fluid outlet 236 can omit the whip tube 240 and the drain tube 112 can be coupled to the suction port 238 instead of the whip tube 240.

[0194] As described above, the fluid outlet 236 is fluidly coupled to the one or morechannels 234 such that the vacuum pressure applied to the fluid outlet 236 propagates into the one or more channels 234. In examples in which the one or more channels 234 includes a plurality of channels 234, the urine diversion device 210 can also include a manifold 242 to distribute the vacuum pressure among the plurality of channels 234. The manifold 242 can include a manifold inlet coupled to the fluid outlet 236 and a plurality of manifold outlets coupled to the plurality channels 234. In this arrangement, the manifold 242 can propagate the vacuum pressure from the manifold inlet to the manifold outlets.

[0195] In some examples, the manifold 242 can be configured to equally distribute the vacuum pressure among the plurality of channels 234. In other examples, the manifold can be configured to distribute a first portion of the vacuum pressure to one channel of the channels 234, distribute a second portion of the vacuum pressure to another channel of the channels 234, and the first portion can be greater than the second portion. For instance, the manifold 242 can be configured to distribute a greater portion of the vacuum pressure to the main channel as compared to the additional channel(s). This can help to use a greater portion of the vacuum pressure for evacuating the fluid and a lesser portion of the vacuum pressure for secondary functions.

[0196] In some examples, the manifold 242 and the backing 224 can be integrally formed as a single, monolithic structure. This can help to simplify a manufacturing process and / or reduce a cost of manufacture. In other examples, the manifold 242 can be formed separately from the backing 224 and then coupled to the backing 224 (e.g., by an adhesive, an ultrasonic weld, a radiofrequency weld, a hot-plate weld, a solvent weld, overmolding, insert molding, hot bar or heat sealing, impulse welding, dielectric welding, and / or induction welding).

[0197] In some examples, the urine diversion device 210 can additionally include a fill member 244 between the backing 224 and the user interface 226. The fill member 244 can help to maintain a separation between at least a portion of the backing 224 and at least a portion of the user interface 226. For example, the fill member 244 can be disposed between the backing 224 and the user interface 226 at the fluid inlet 230. As such, the fill member 244 can be formed from a fluid permeable material such as, for instance, a foam material (e.g., an opencell foam material and / or a closed-cell foam material), and / or a batting material. In some examples, the fill member 244 can be an absorbent material that can help to wick the fluid away from the fluid inlet 230 and towards the backing 224.

[0198] As shown in Figure 2, in some examples, the backing 224 can also include a recess 246. The recess 246 can define a depression in the proximal surface of the backing 224 that can be fluidly coupled to the manifold 242 and / or the fluid outlet 236. In some implementations, the recess 246 can include an axial portion extending in an axial direction between an inferior end of the backing 224 and a superior end of the backing 224. In some implementations, the recess 246 can further include a plurality of branch portions extending from the axial portion in one or more directions that are transverse to the axial direction. This can help to distribute the vacuum pressure within the one or more channels 234. For instance, the recess 246 can be positioned in the main channel to help distribute the vacuum pressure over a greater surface area of the main channel.

[0199] In some implementations that include the recess 246 and the fill member 244, the fill member 244 can extend across the recess 246 such that a gap is formed between the fill member 244 and the backing at the recess 246. This can help to address resistance to airflow that may be introduced by the fill member 244 in the one or more channels 234.

[0200] As shown in Figure 2, the urine diversion device 210 can additionally include an attachment member 248 in some examples. The attachment member 248 can be configured to couple the backing 224 and / or the user interface 226 to the user. The attachment member 248 can thus help to maintain a position of the urine diversion device 210 relative to the user. This can help to receive the urine into the fluid inlet 230 and / or mitigate leakage of urine out of the internal cavity 228. As examples, the attachment member 248 can include one or more components selected from a group consisting of an adhesive, a tape, an elastic band, a drawstring, a cinch strap, and a strap that extends around a waist, a torso, or a leg of the user.

[0201] Figures 3 A-3C depict a urine diversion device 310 as an implementation of the urine diversion device 210 shown and described with respect to Figure 2, according to an example. In particular, Figure 3 A depicts a proximal side of the urine diversion device 310, Figure 3B depicts a distal side of the urine diversion device 310, and Figure 3C depicts an exploded view of the urine diversion device 310, according to the example. Figure 3D depicts a proximal surface 324A of the backing 224 shown in Figures 3A-3C, and Figure 3E depicts a distal surface 324B of the backing 224 shown in Figures 3A-3C, according to the example.

[0202] As shown in Figures 3D-3E, the backing 224 includes an inferior end 324C, a superior end 324D, a first lateral side 324E extending between the inferior end 324C and the superior end 324D, a second lateral side 324F extending between the inferior end 324C and thesuperior end 324D. The second lateral side 324F is opposite the first lateral side 324E. The proximal surface 324A extends between the inferior end 324C, the superior end 324D, the first lateral side 324E, and the second lateral side 324F. The distal surface 324B extends between the inferior end 324C, the superior end 324D, the first lateral side 324E, and the second lateral side 324F. As shown in Figures 3C-3D, the inferior end 324C, the superior end 324D, the first lateral side 324E, and / or the second lateral side 324F can include an outer wall of the backing 224, which extends in the proximal direction from the proximal surface 324A. This can help to define one or more of the channel(s) 234, mitigate leakage, and / or assist in coupling the user interface 226 and the backing 224 to each other.

[0203] As shown in Figures 3A-3C, the urine diversion device 310 includes the backing 224 and the user interface 226 coupled to the backing 224, and the user interface 226 is proximal of the backing 224. The urine diversion device 310 also includes the internal cavity 228 between the backing 224 and the user interface 226.

[0204] The user interface 226 includes the fluid inlet 230 that is configured to receive the fluid into the internal cavity 228. As shown in Figure 3C, in this example implementation, the user interface 226 can include a permeable layer 326A at the fluid inlet 230 and a peripheral layer 326B that extends around the permeable layer 326A. The permeable layer 326A can be configured to pass fluid from the body of the user into the internal cavity 228. The peripheral layer 326B can be configured to enhance user comfort. For instance, in one example, the peripheral layer 326B can be formed from a microfiber material.

[0205] As shown in Figures 3C-3D, the backing 224 includes the inner walls 232 extending from the proximal surface 324A of the backing 224, and the inner walls 232 define a plurality of channels 334A-334E in the internal cavity 228. Additionally, as shown in Figure 3A-3C, the urine diversion device 310 includes the fluid outlet 236 configured to egress the fluid out of the internal cavity 228 responsive to a vacuum pressure applied to the fluid outlet 236. The fluid outlet 236 is fluidly coupled to the plurality of channels 334A-334E such that the vacuum pressure applied to the fluid outlet 236 propagates into the plurality of channels 334A-334E.

[0206] In this example, the plurality of channels 334A-334E include a main channel 334A positioned below the fluid inlet 230 (e.g., distal of the fluid inlet 230). As shown in Figure 3C, the main channel 334A is aligned with and distal to the fluid inlet 230 such that the main channel 334A can receive the fluid from the fluid inlet 230. Also, as shown in Figure 3C, theurine diversion device 310 can include the fill member 244 disposed in the main channel 334A. The inner walls 232 that define the main channel can help to maintain the fill member 244 in a fixed position relative to the fluid inlet 230 (e.g., the inner walls 232 can resist movement or migration of the fill member 244 out of the main channel 334A). In this arrangement, the fluid discharged from the user can pass through the permeable layer 326A of the user interface 226 at the fluid inlet 230 to the fill member 244, then through the fill member 244 and along the main channel 334A to the fluid outlet 236, and out the fluid outlet 236 (e.g., along the drain tube 112 towards the waste collection receptacle 114). Within examples, the vacuum pressure applied to the main channel 334A can direct the fluid along this this flow pathway and against the force of gravity.

[0207] Additionally, in the example shown in Figures 3 A-3E, the plurality of channels 334A-334E include a first side channel 334B extending along a first lateral side of the main channel 334A and a second side channel 334C extending along a second lateral side of the main channel 334A. The first side channel 334B can also extend along a first lateral side of the fluid inlet 230 and the second side channel 334C can also extend along a second lateral side of the fluid inlet 230. In some implementations, the first side channel 334B and / or the second side channel 334C can help to direct air flow through the internal cavity 228 to assist in drying out the urine diversion device 310 and / or improve user comfort.

[0208] In the example shown in Figures 3A-3E, the plurality of channels 334A-334E further include a third side channel 334D extending between the first side channel 334B and the first lateral side 324E of the backing 224, and a fourth side channel 334E extending between the second side channel 334C and the second lateral side 324F. In some implementations, the third side channel 334D and / or the fourth side channel 334E can additionally or alternatively help to direct air flow through the internal cavity 228 to assist in drying out the urine diversion device 310 and / or improve user comfort.

[0209] In this example, the air flow within the first side channel 334B and the second side channel 334C can differ from the air flow through the third side channel 334D and the fourth side channel 334E due, at least in part, to one or more features of the user interface 226 and / or the backing 224. For instance, as shown in Figures 3A and 3C, the user interface 226 can include a plurality of interface apertures 350 extending along the first lateral side and the second lateral side of the fluid inlet 230, and the interface apertures 350 can be in communication with the first side channel 334B and the second side channel 334C. When the urine diversion device 310 is positioned on the user, the interface apertures 350 can contact askin of the user. In this arrangement, the vacuum pressure applied to the first side channel 334B and the second side channel 334C can generate air flow through the interface apertures 350 that can assist in drying the skin of the user and / or cooling the skin of the user. Additionally or alternatively, in some implementations, the vacuum pressure applied to the first side channel 334B and the second side channel 334C can assist in gently securing the user interface 226 to the skin of the user.

[0210] Additionally or alternatively, as shown in Figure 3B, the backing 224 can include a first channel inlet 352 A in communication with the first side channel 334B and a second channel inlet 352B in communication with the second side channel 334C. In Figure 3B, the backing 224 includes the first channel inlet 352 A at an inferior portion of the first side channel 334B and the second channel inlet 352B at an inferior portion of the second side channel 334C. However, the first channel inlet 352A and / or the second channel inlet 352B can be at different locations along the first side channel 334B and / or the second side channel 334C, respectively, in other examples. Unlike the interface apertures 350, the first channel inlet 352A and the second channel inlet 352B are not configured to contact the skin of the user when the urine diversion device 310 is positioned on the user. As such, the first channel inlet 352A and the second channel inlet 352B can be free of obstruction and enhance air flow into the first side channel 334B and the second side channel 334C responsive to the vacuum pressure applied to the first side channel 334B and the second side channel 334C.

[0211] As shown in Figure 3C, in some examples, the urine diversion device 310 can include a hydrophobic barrier 354 at the first channel inlet 352 A and the second channel inlet 352B. The hydrophobic barrier 354 can be configured to inhibit ingress of contaminants into the first side channel 334B and the second side channel 334C. The hydrophobic barrier 354 can be further configured to allow air to enter into the first side channel 334B and the second side channel 334C.

[0212] In contrast the first side channel 334B and the second side channel 334C, the user interface 226 and the backing 224 do not include apertures or inlets in communication with the third side channel 334D and the fourth side channel 334E. As a result, the air flow through the third side channel 334D and the fourth side channel 334E can differ from the air flow through the first side channel 334B and the second side channel 334C responsive to the vacuum pressure.

[0213] As shown in Figure 3D, the urine diversion device 310 includes the manifold242, which is configured to (i) propagate a first portion of the vacuum pressure to the main channel 334A, and (ii) propagate a second portion of the vacuum pressure to the first side channel 334B and the second side channel 334C. Additionally, in this example, the manifold 242 can be configured to propagate a third portion of the vacuum pressure to the third side channel 334D and the fourth side channel 334E.

[0214] Figure 3F depicts a cross-sectional view of the backing 224 at the manifold 242 though a plane that extends through the inferior end 324C, the superior end 324D, the first lateral side 324E, and the second lateral side 324F of the backing 224. As shown in Figure 3F, the manifold 242 can include a manifold inlet 342A coupled to the fluid outlet 236 and a plurality of manifold outlets 342B-342F coupled to the plurality channels 334A-334E. For instance, in Figure 3F, the manifold 242 includes a first manifold outlet 342B fluidly coupled to the main channel 334A, a second manifold outlet 342C fluidly coupled to the first side channel 334B, a third manifold outlet 342D fluidly coupled to the second side channel 334C, a fourth manifold outlet 342E fluidly coupled to the third side channel 334D, and a fifth manifold outlet 342F fluidly coupled to the fourth side channel 334E. In this arrangement, the manifold 242 can propagate the vacuum pressure received at the manifold inlet 342A from the fluid outlet 236 to the channels 334A-334E via the manifold outlets 342B-342F.

[0215] In Figures 3 A-3F, the manifold 242, the backing 224, and the inner walls 232 are integrally formed as a single, monolithic structure. However, in other examples, the manifold 242, the backing 224, and / or the inner walls 232 can be separate structures that are coupled to each other.

[0216] As shown in Figures 3A-3C, the urine diversion device 310 also includes the suction port 238 for coupling to the drain tube 112. As shown in Figure 3C, the backing 224 can include a receptacle 356 that is configured to receive and couple to the suction port 238. The suction port 238 can include an inferior portion that is configured to be inserted in the receptacle 356, and a superior portion that extends in a superior direction from the receptacle 356 for coupling to the drain tube 112. As shown in Figure 3C, the inferior portion of the suction port 238 can have a length that is less than a length of the receptacle 356 such that the suction port 238 does not extend into the internal cavity 228. Additionally, as shown in Figure 3F, the receptacle 356 can extend terminate at the superior end 324D of the backing 224 such that the receptacle 356 does not extend into the internal cavity 228. In other examples, a portion of the suction port 238 and / or the receptacle 356 can extend at least partially into the internal cavity 228.

[0217] As shown in Figure 3A and Figure 3D, the backing 224 can also include a shield portion 358 at the inferior end 324C of the backing 224. The shield portion 358 can be configured to inhibit ingress of fecal matter into the internal cavity 228. For instance, the shield portion 358 can be formed from a liquid impermeable material. Additionally or alternatively, the shield portion 358 can include a hydrophobic membrane, which is air permeable but liquid impermeable. Within examples, the shield portion 358 can be flexible or rigid.

[0218] Figures 4A-4B depict a urine diversion device 410 as another implementation of the urine diversion device 210 and the urine diversion device 310, according to another example. In particular, Figure 4A depicts a proximal side of the urine diversion device 410, and Figure 4B depicts a distal side of the urine diversion device 410, according to the example. Figure 4C depicts a proximal surface 324A of the backing 224 shown in Figures 4A-4B.

[0219] The urine diversion device 410 shown in Figures 4A-4C is substantially similar or identical to the urine diversion device 310 shown in Figures 3 A-3F, except the backing 224 of the implementation shown in Figures 4A-4C is configured differently than the backing 224 of the implementation shown in Figures 3 A-3F in several respects.

[0220] Accordingly, as shown in Figures 4A-4C, the urine diversion device 410 includes the backing 224 and the user interface 226 coupled to the backing 224, and the user interface 226 is proximal of the backing 224. The urine diversion device 210 also includes the internal cavity 228 between the backing 224 and the user interface 226. The user interface 226 includes the fluid inlet 230 that is configured to receive the fluid into the internal cavity 228. As shown in Figures 4C, the backing 224 includes the inner walls 232 extending from the proximal surface 324A of the backing 224, and the inner walls 232 define a plurality of channels 434A-434Cin the internal cavity 228. Additionally, as shown in Figure 4A-4B, the urine diversion device 310 includes the fluid outlet 236 configured to egress the fluid out of the internal cavity 228 responsive to a vacuum pressure applied to the fluid outlet 236. The fluid outlet 236 is fluidly coupled to the plurality of channels 434A-434C such that the vacuum pressure applied to the fluid outlet 236 propagates into the plurality of channels 434A-434C.

[0221] One difference between the backing 224 of the urine diversion device 410 relative to the backing of the urine diversion device 310 is that the backing 224 of this example implementation omits the third side channel 334D and the fourth side channel 334E of the backing 224 of the urine diversion device 310 shown in Figure 3D. As shown in Figure 4C, the plurality of channels 434A-434C include a main channel 434A positioned below the fluidinlet 230 (e.g., distal of the fluid inlet 230). Additionally, the channels 434A-434C include a first side channel 434B extending along a first lateral side of the main channel 434A and a second side channel 434C extending along a second lateral side of the main channel 434A. The first side channel 434B can also extend along a first lateral side of the fluid inlet 230 and the second side channel 434C can also extend along a second lateral side of the fluid inlet 230. As described above, in some implementations, the first side channel 434B and / or the second side channel 434C can help to direct air flow through the internal cavity 228 to assist in drying out the urine diversion device 310 and / or improve user comfort.

[0222] As shown in Figure 4C, the urine diversion device 310 includes the manifold 242, which is configured to (i) propagate a first portion of the vacuum pressure to the main channel 434A, and (ii) propagate a second portion of the vacuum pressure to the first side channel 434B and the second side channel 434C. Figure 4D depicts a cross-sectional view of the backing 224 at the manifold 242 though a plane that extends through the inferior end 324C, the superior end 324D, the first lateral side 324E, and the second lateral side 324F of the backing 224. Figure 4E depicts a cross-sectional view through a longitudinal axis 460 of the backing 224, which also shows the manifold 242, according to the example.

[0223] As shown in Figure 4D, the manifold 242 can include a manifold inlet 342A at the fluid outlet 236 and a plurality of manifold outlets 342B-342C coupled to the plurality channels 434A-434C. For instance, in Figure 4D, the manifold 242 includes a first manifold outlet 342B fluidly coupled to the main channel 434A, a second manifold outlet 342C fluidly coupled to the first side channel 434B and the second side channel 434C. In this arrangement, the manifold 242 can propagate the vacuum pressure received at the manifold inlet 342A from the fluid outlet 236 to the channels 434A-434C via the manifold outlets 342B-342C.

[0224] As shown in Figure 4E, the manifold 242 can include a first manifold surface 462A extending from the fluid outlet 236 towards an inferior end 324C of the backing 224, and a second manifold surface 462B that extends in a proximal direction towards the user interface 226 from the first manifold surface 462A. A superior end of the first manifold surface 462A extends between two points on a circumference of an inferior end of the fluid outlet 236 such that the first portion of the vacuum pressure propagates proximal to the first manifold surface 462A into the main channel 434A, and second portion of the vacuum pressure propagates distal to the first manifold surface 462A into the first side channel 434B and the second side channel 434C.

[0225] As shown in Figure 4C, the backing 224 of the urine diversion device 410 also includes the recess 246. The recess 246 can define a depression in the proximal surface 324A of the backing 224 that is fluidly coupled to the manifold 242 at the first manifold outlet 342B. In this implementation, the recess 246 includes an axial portion extending in an axial direction (e.g., along the longitudinal axis 460 between the inferior end 324C of the backing 224 and the superior end 324D of the backing 224). This can help to distribute the vacuum pressure within the main channel 434A (e.g., through a gap between the fill member 244 and the backing 224 at the recess 246).

[0226] Figures 5A-5B depict a urine diversion device 510 as another implementation of the urine diversion devices 210, 310, 410, according to another example. In particular, Figure 5A depicts a proximal side of the urine diversion device 510, and Figure 5B depicts a distal side of the urine diversion device 510, according to the example. The urine diversion device 510 shown in Figures 5A-5B is substantially similar or identical to the urine diversion device 410 shown in Figures 4A-4E, except the user interface 226 includes a single material that extends across an entirety of the proximal surface 324A of the backing 224, and the recess 246 includes an axial portion 564A and a plurality of branch portions 564B extending from the axial portion 564A in one or more directions that are transverse to the axial direction defined by the longitudinal axis 460.

[0227] Figures 6A-6B depict a urine diversion device 610 as another implementation of the urine diversion devices 210, 310, 410, 510, according to another example. In particular, Figure 6A depicts a proximal side of the urine diversion device 610, and Figure 6B depicts a distal side of the urine diversion device 610, according to the example. Figure 6C depicts the backing 224 of the urine diversion device 610, according to the example.

[0228] The urine diversion device 610 shown in Figures 6A-6B is substantially similar or identical to the urine diversion device 410 shown in Figures 4A-4E, except the urine diversion device 610 also includes a plurality of integrated attachment members 648. The integrated attachment members 648 can be portions of the user interface 226 that include an adhesive for coupling to the skin of the user. As shown in Figure 6C, the backing 224 can also include a plurality of wing portions 662 that can support the integrated attachment members 648 on the user interface 226. As shown in Figures 6A-6C, the wing portions 662 and the integrated attachment members 648 can be locate on opposing lateral sides of the fluid inlet 230. This can position the adhesive of the integrated attachment members 648 at locations on the user that are less likely to be sensitive to the adhesive.

[0229] Referring now to Figure 7, a simplified block diagram of a urine diversion device 710 is shown for an implementation of the urine diversion device 110 described above, according to some examples. As shown in Figure 7, the urine diversion device 210 includes a backing 766 having a proximal side and a distal side, a vacuum port 768 coupled to the distal side of the backing 766, a wicking material 770 coupled to the proximal side of the backing 766, and a rim 772 coupled to the backing 766 and extending around the wicking material 770. As described in further detail below, the wicking material 770 is configured to wick a fluid in a distal direction towards the backing 766. The backing 766 includes a plurality of vacuum apertures 774 on the proximal side that are configured to evacuate the fluid from the wicking material 770 out of the vacuum port 768.

[0230] In use, the urine diversion device 110 can be positioned on the user with wicking material 770 facing toward the user and the distal side of the backing 766 facing away from the user. For instance, the urine diversion device 110 can be positioned with the wicking material 770 adjacent to a urethral opening of the user. In this position, a fluid discharged from the body of the user can be received in the wicking material 770. The wicking material 770 can wick the fluid in the distal direction towards the backing 766. When a vacuum pressure is applied to the vacuum port 768 (e.g., by the vacuum device 116 via the air tube 122 and the drain tube 112), the vacuum pressure can propagate through the vacuum apertures 774 to the fluid and the wicking material 770. With the assistance of the vacuum pressure, the fluid can be egressed through the vacuum apertures 774 and the vacuum port 768 to the drain tube 112 and the waste collection receptacle 114.

[0231] In some examples, the backing 766 can be a liquid impermeable material. This can help to mitigate leakage of the fluid through the backing 755. The backing 766 can additionally or alternatively be a flexible material. This can allow the backing 224 to conform to a shape of an anatomy of the user when the urine diversion device 710 is positioned on the user. In other examples, the backing 766 can be formed from a substantially rigid material.

[0232] In some examples, the backing 766 can be curved along a longitudinal axis extending between an inferior end of the backing 766 and a superior end of the backing 766. This can additionally or alternatively assist in positioning the urine diversion device 710 on the user.

[0233] In some examples, the backing 766 can be malleable such that the backing 766 is configured to be manually shaped (e.g., under forces typically applicable by human fingerswithout the assistance of a machine) prior to, during, or after positioning the urine diversion device 710 on the user. For instance, the backing 766 can include one or more shape retaining elements coupled to and / or embedded in a base material of the backing 766. As examples, the one or more shape retaining elements can include at least one structure selected from a group consisting of: a metal wire and a plastic material. In some examples, the one or more shape retaining elements can be configured to be made malleable responsive to an external stimulus (e.g., heat, electrical signal, pressure, and light). Forming the backing 766 of a malleable material can beneficially help to adjust a shape of the urine diversion device 710 according to a particular anatomy of a user on which the urine diversion device 710 is to be positioned.

[0234] Additionally or alternatively, in implementations in which the backing 766 is malleable and / or flexible, the urine diversion device 710 can be manufactured, shipped, and stored in a shape that is more compact (e.g., a straight shape) while allowing the urine diversion device 710 to be subsequently bent to form a curve that can help to better conform the urine diversion device 710 to the anatomy of the user.

[0235] In other examples, the backing 766 can be non-malleable. For instance, in some implementations in which the backing 766 is flexible, the backing 766 can be non- malleable to reduce costs, simplify manufacturing, and / or avoid the use of certain malleable materials (e.g., avoid metal materials). In some examples, the backing 766 can be non- malleable and substantially rigid. In such examples, the backing 766 can have a shape and / or a size that is suitable to fit most anatomies of users (e.g., a one-size fits most), and / or the backing 766 can be manufactured with a plurality of different shapes and / or a plurality of different sizes such that a user can select a shape and a size that best fits the user.

[0236] As an example, the backing 766 can include at least one thermoplastic material selected from a group consisting of: polyethylene, polypropylene, acrylonitrile butadiene styrene (ABS), polyvinyl chloride, and polycarbonate.

[0237] As noted above, the wicking material 770 can be configured to wick the fluid in a distal direction towards the backing 766. For instance, wicking material 770 can include a fibrous material that is configured to draw the urine toward the backing 766 under capillary action. As examples, the wicking material 770 can include at least one material selected from a group consisting of: a woven material and a non-woven material. Additionally or alternative, wicking material 770 can include at least one material selected from a group consisting of: polyester and polypropylene.

[0238] In some examples, the wicking material 770 can be in the form of a pad. This can help to make the wicking material 770 easy to handle during manufacture and / or assembly of the urine diversion device 710. Within examples, the wicking material 770 can cover an entirety of the proximal side of the backing 766 in a space defined by the rim 772. This can help to utilize enhance capturing the fluid over a relatively larger portion of the urine diversion device 710 as compared to other examples in which a gap exists between the wicking material 770 and the rim 772. In other examples, the wicking material 770 can extend around and enclose the backing 755 and the rim 772 (e.g., as shown in Figures 13A-13B).

[0239] In some examples, the wicking material 770 can be recessed distally relative to the rim 772. This can help to improve capture of the fluid discharged from the body of the user and / or mitigate (or prevent) leakage of the fluid from the wicking material 770. Additionally or alternatively, in implementations in which the wicking material 770 is recessed distally relative to the rim 772, a gap can be provided between at least a portion of the wicking material 770 and the user when the urine diversion device 710 is positioned on the user. This can reduce an extent of contact between the user and the urine diversion device 710, which can help to improve user comfort and / or remove assist in removing moisture from contact with the skin of the user. In other examples, the wicking material 770 can protrude distally from the rim 772 and / or a distal side of the wicking material 770 and a distal side of the rim 772 can be substantially coplanar.

[0240] In some examples, the rim 772 can be a liquid impermeable material. This can additionally or alternatively help to improve capture of the fluid discharged from the body of the user and / or mitigate (or prevent) leakage of the fluid from the wicking material 770. In some examples, the rim 772 can additionally or alternatively include a fabric material. This can help to provide a softer material in contact with the user and thereby improve user comfort. In some examples, the rim 772 can include a tacky material (e.g., a high-tack, low-durometer, skin-friendly material) that is configured to resist movement of the urine diversion device relative to a skin of a user. As examples, the rim 772 can be formed from at least one material selected from a group consisting of: silicone and polyvinyl alcohol.

[0241] In general, the vacuum port 768 is configured to couple to the drain tube 112 and the vacuum device 116 such that the vacuum port 768 can receive the vacuum pressure from the vacuum device 116 and propagate the vacuum pressure to the backing 766. In some examples, the vacuum port 768 can be formed of a substantially rigid material that can help to couple to the drain tube 112. As examples, the vacuum port 768 can include at least one fittingselected from a group consisting of: a luer coupling, a push-on connector, a threaded connector, and a bayonet connector. In another example, the vacuum port 768 can include a tapered end portion for coupling with the drain tube 112 (e.g., a distal end of the vacuum port 768 can have an outer diameter that decreases along a distal direction). Given that drain tubes 112 may have different sizes (e.g., depending on the make and / or model of the vacuum device 116), the tapered end portion of the vacuum port 768 can help to more universally couple the vacuum port 768 to a plurality of differently sized drain tubes 112.

[0242] In some examples, the vacuum port 768 can be fixedly coupled to the backing 766 such that the vacuum port 768 is not rotatable relative to the backing 766. This can simplify a manufacturing process and / or reduce a cost of manufacture. In such examples, the vacuum port 768 can have a single configuration and orientation relative to the backing 766. For instance, the vacuum port 768 can face a superior end of the backing 766. This can beneficially allow for the drain tube 112 to be routed over the user as opposed to under the user and / or reduce bending of the drain tube 112. In other examples, the vacuum port 768 can face an inferior end of the back 766, or another direction.

[0243] In other examples, the vacuum port 768 can be rotatably coupled to the backing 766 such that the vacuum port 768 can rotate about an axis relative to the backing 766. For instance, the vacuum port 768 can include a joint that is configured to allow the vacuum port 768 to rotate about the axis. In this arrangement, rotation of the vacuum port 768 can help to inhibit twisting or kinking of the drain tube 112 and / or improve user comfort.

[0244] In some implementations, the vacuum port 768 is freely rotatable by more than 360 degrees relative to the backing 766. This can help mitigate twisting and kinking in all rotational positions of the drain tube 112 relative to the backing 766. However, in other implementations, the vacuum port 768 can be rotatable by less than 360 degrees relative to the backing 766. This may help to constrain the drain tube 112 to a particular range of positions relative to the backing 766, which may beneficially help to maintain the drain tube 112 at a position extending away from the user.

[0245] In some examples, the vacuum port 768 can also include a whip tube that extends between the aperture in the backing 766 and the vacuum port 768. The whip tube can help to extend the vacuum port 768 farther away from the backing 766 than other implementations in which the vacuum port 768 is directly coupled to the backing 766. In other examples, the vacuum port 768 can omit the whip tube and the drain tube 112 can be coupledto the vacuum port 768 instead of the whip tube.

[0246] In some examples, wherein the vacuum port 768 can be located adjacent to an inferior end of the backing 766 (e.g., within a distance from the inferior end that is less than approximately 10% of a total length of the backing 766 between the inferior end and the superior end of the backing 766). This may be beneficial in that gravity can assist the fluid flowing towards the vacuum port 768. In some such examples,

[0247] In other examples, the vacuum port 768 can be located adjacent to a superior end of the backing 766 (e.g., within a distance from the superior end that is less than approximately 10% of a total length of the backing 766 between the inferior end and the superior end of the backing 766). This can beneficially position the drain tube 112 away from the user and / or improve routing of the drain tube 112 (e.g., by reducing bending and / or kinking of the drain tube 112).

[0248] In other examples, the vacuum port 768 can be located at an intermediate portion of the backing 766 (e.g., within a middle 80% of a total length of the backing 766 between the inferior end and the superior end of the backing 766). This can provide a balance between suction considerations and drain tube routing considerations.

[0249] As noted above, the backing 766 includes the vacuum apertures 744 on the proximal side of the backing 766, and the vacuum apertures 744 are configured to evacuate the fluid from the wicking material 770 out of the vacuum port 768. In some examples, the vacuum apertures 744 can be located directly opposite the vacuum port 768. In other examples, the backing 766 can include one or more vacuum conduits extending from the vacuum port 768 to the plurality of vacuum apertures 774. In such examples, the vacuum conduits can allow the vacuum apertures 774 to be positioned in different positions relative to the vacuum port 768. This can help to better distribute the vacuum pressure over the backing 766 and the wicking material 770, and improve urine diversion.

[0250] In some examples, the backing 766 includes a proximal layer coupled to a distal layer, the wicking material 770 is coupled to the proximal layer, the vacuum apertures 774 are in the proximal layer, and the vacuum port 768 is coupled to the distal layer. In this arrangement, the backing 766 can include one or more vacuum conduits extending (i) between the proximal layer and the distal layer and (ii) from the vacuum port 768 to the plurality of vacuum apertures 774.

[0251] As shown in Figure 7, the urine diversion device 710 can additionally includean attachment member 776 in some examples. The attachment member 776 can be configured to couple the backing 766 to the user. The attachment member 776 can thus help to maintain a position of the urine diversion device 710 relative to the user. This can help to receive the urine into the wicking material 770 and / or mitigate leakage of the fluid. As examples, the attachment member 776 can include one or more components selected from a group consisting of an adhesive, a tape, an elastic band, a drawstring, a cinch strap, and a strap that extends around a waist, a torso, or a leg of the user.

[0252] Figures 8 A-8C depict a urine diversion device 810 as an implementation of the urine diversion device 710 shown and described with respect to Figure 7, according to an example. In particular, Figure 8 A depicts a proximal side of the urine diversion device 810, Figure 8B depicts a distal side of the urine diversion device 810, and Figure 8C depicts a partially exploded view of the urine diversion device 810, according to the example.

[0253] As shown in Figures 8A-8C, the urine diversion device 810 includes the backing 766 having a proximal side 866A (shown in Figure 8C) and a distal side 866B (shown in Figure 8B), the vacuum port 768 coupled to the distal side 866B of the backing 766, the wicking material 770 coupled to the proximal side 866A of the backing 766, and the rim 772 coupled to the backing 766 and extending around the wicking material 770. Additionally, as shown in Figure 8C, the backing 766 includes the plurality of vacuum apertures 774 on the proximal side 866A that are configured to evacuate the fluid from the wicking material 770 out of the vacuum port 768.

[0254] As shown in Figure 8C, the backing 766 includes an inferior end 866C, a superior end 866D, a first lateral side 866E extending between the inferior end 866C and the superior end 866D, a second lateral side 866F extending between the inferior end 866C and the superior end 866D. The second lateral side 866F is opposite the first lateral side 866E. The proximal side 866A extends between the inferior end 866C, the superior end 866D, the first lateral side 866E, and the second lateral side 866F. The distal side 866B extends between the inferior end 866C, the superior end 866D, the first lateral side 866E, and the second lateral side 866F.

[0255] As shown in Figures 8A-8C, the backing 766 can have an hour glass shape. For instance, along a direction from the superior end 866D to the inferior end 866C of the backing 766, the backing 766 tapers inwardly toward a center axis 878 from the superior end 866D towards an intermediate portion, and tapers outwardly away from the center axis 878from the intermediate portion towards the inferior end 866C. Within examples, the hour glass shape of the backing 766 can assist in coupling the urine diversion device 810 to the user.

[0256] As shown in Figure 8C, the wicking material 770 can be recessed distally relative to the rim 772. This can help to improve capture of the fluid discharged from the body of the user and / or mitigate (or prevent) leakage of the fluid from the wicking material 770. Additionally or alternatively, in implementations in which the wicking material 770 is recessed distally relative to the rim 772, a gap can be provided between at least a portion of the wicking material 770 and the user when the urine diversion device 710 is positioned on the user. This can reduce an extent of contact between the user and the urine diversion device 710, which can help to improve user comfort.

[0257] As shown in Figure 8B, the vacuum port 768 can be located adjacent to an inferior end of the backing 766 (e.g., within a distance from the inferior end 866C that is less than approximately 10% of a total length of the backing 766 between the inferior end 866C and the superior end 866D of the backing 766). This may be beneficial in that gravity can assist the fluid flowing towards the vacuum port 768. Additionally, in Figure 8B, the vacuum port 768 faces the superior end 866D of the backing 766. This can beneficially allow for the drain tube 112 to be routed over the user as opposed to under the user and / or reduce bending of the drain tube 112. In other examples, the vacuum port 768 can face an inferior end of the back 766, or another direction.

[0258] As noted above, the backing 766 includes the vacuum apertures 744 on the proximal side of the backing 766, and the vacuum apertures 744 are configured to evacuate the fluid from the wicking material 770 out of the vacuum port 768. In the example shown in Figures 8B-8C, the backing 766 includes one or more vacuum conduits extending from the vacuum port 768 to the plurality of vacuum apertures 774. In Figures 8A-8C, the vacuum conduit(s) are internal to the backing 766. The vacuum conduits can allow the vacuum apertures 774 to be positioned in different positions relative to the vacuum port 768. This can help to better distribute the vacuum pressure over the backing 766 and the wicking material 770, and improve urine diversion.

[0259] Figures 9A-9B depict a urine diversion device 910 as another implementation of the urine diversion devices 710, 810, according to another example. In particular, Figure 9A depicts a proximal side of the urine diversion device 910, and Figure 9B depicts a distal side of the urine diversion device 910, according to the example.

[0260] In this example, the backing 766 includes the vacuum apertures 744 on the proximal side of the backing 766, and the vacuum apertures 744 are configured to evacuate the fluid from the wicking material 770 out of the vacuum port 768. Additionally, the backing 766 includes one or more vacuum conduits 980A-980C extending from the vacuum port 768 to the plurality of vacuum apertures 774. Additionally, in this example, the backing 766 includes a proximal layer 976A coupled to a distal layer 976B, the wicking material 770 is coupled to the proximal layer 976A, the vacuum apertures 774 are in the proximal layer 976A, and the vacuum port 768 is coupled to the distal layer 976B. In this arrangement, the backing 766 can include the one or more vacuum conduits 980A-980C extending (i) between the proximal layer and the distal layer and (ii) from the vacuum port 768 to the plurality of vacuum apertures 774.

[0261] As shown in Figure 9B, the one or more vacuum conduits 980A-980C can include a first conduit 980A that extends along a longitudinal axis 978 of the backing 766. Additionally, the one or more vacuum conduits 980A-980C can a second conduit 980B and a third conduit 980C that extend in respective directions that are transverse to the longitudinal axis 978. As shown in Figure 9B, the vacuum conduits 980A-980C can allow the vacuum apertures 774 to be positioned in different positions relative to the vacuum port 768. This can help to better distribute the vacuum pressure over the backing 766 and the wicking material 770, and improve urine diversion.

[0262] Referring now to Figures 10A-10B, a urine diversion device 1010 is shown for an implementation of the urine diversion device 110 described above, according to an additional example. In particular, Figure 10A shows a distal side of the urine diversion device 1010 and Figure 10B shows a cross-sectional view through a line 1011 in Figure 10 A, according to the example. As shown in Figures 10A-10B, the urine diversion device 1010 incudes a vacuum port 1082, a wicking material 1084, and an adhesive sheet 1086.

[0263] The vacuum port 1082 incudes a proximal flange 1082A, a distal flange 1082B, a shaft portion 1082C extending between the proximal flange 1082A and the distal flange 1082B, and a connector 1082D extending distally from the distal flange 1082B. In general, the connector 1082D is configured to couple to the drain tube 112 and the vacuum device 116 such that the vacuum port 1082 can receive the vacuum pressure from the vacuum device 116. In some examples, the connector 1082D can be formed of a substantially rigid material that can help to couple to the drain tube 112. As examples, the connector 1082D can include at least one fitting selected from a group consisting of: a luer coupling, a push-on connector, a threaded connector, and a bayonet connector. In another example, the connector 1082D can include atapered end portion for coupling with the drain tube 112 (e.g., a distal end of the connector 1082D can have an outer diameter that decreases along a distal direction). Given that drain tubes 112 may have different sizes (e.g., depending on the make and / or model of the vacuum device 116), the tapered end portion of the connector 1082D can help to more universally couple the vacuum port 768 to a plurality of differently sized drain tubes 112.

[0264] In some examples, the connector 1082D can be fixedly coupled to the distal flange 1082B such that the connector 1082D is not rotatable relative to the distal flange 1082B. This can simplify a manufacturing process and / or reduce a cost of manufacture. In such examples, the connector 1082D can have a single configuration and orientation relative to the distal flange 1082B.

[0265] In other examples, the connector 1082D can be rotatably coupled to the distal flange 1082B such that the connector 1082D can rotate about an axis relative to the distal flange 1082B. For instance, the connector 1082D can include a joint that is configured to allow the connector 1082D to rotate about the axis. In this arrangement, rotation of the connector 1082D can help to inhibit twisting or kinking of the drain tube 112 and / or improve user comfort.

[0266] In some implementations, the connector 1082D is freely rotatable by more than 360 degrees relative to the distal flange 1082B. This can help mitigate twisting and kinking in all rotational positions of the drain tube 112 relative to the vacuum port 1082. However, in other implementations, the connector 1082D can be rotatable by less than 360 degrees relative to the distal flange 1082B. This may help to constrain the drain tube 112 to a particular range of positions relative to the distal flange 1082B, which may beneficially help to maintain the drain tube 112 at a position extending away from the user.

[0267] The wicking material 1084 can have a proximal side 1084A, a distal side 1084B, and an aperture 1084C extending through the proximal side 1084A and the distal side 1084B. As examples, the wicking material 1084 can include at least one material selected from a group consisting of: polyester and polypropylene.

[0268] The adhesive sheet 1086 can have a proximal side 1086A, a distal side 1086B, and an aperture 1086C extending through the proximal side 1086A and the distal side 1086B. Within examples, the adhesive sheet 1086 can include a flexible material (e.g., polyurethane). In some examples, the adhesive sheet 1086 can additionally or alternatively include a breathable material, a translucent material, a transparent material, and / or a liquid impermeable material. The adhesive sheet 1086 includes an adhesive on the proximal side 1086 A of theadhesive sheet 1086. As an example, the adhesive can be an acrylic adhesive.

[0269] As shown in Figure 10B, the shaft portion 1082C of the vacuum port 1082 extends through the aperture 1084C of the wicking material 1084 and the aperture 1086C of the adhesive sheet 1086. As also shown in Figure 10B, the vacuum port 1082 can have a lumen with a longitudinal axis 1088. The proximal flange 1082A can have a size, in a first plane that is orthogonal to the longitudinal axis 1088 of the vacuum port 1082, which is greater than a size of the shaft portion 1082C in a plane that is parallel to the first plane. Similarly, the distal flange 1082B can have a size, in a second plane that is orthogonal to the longitudinal axis 1088, which is greater than a size of the shaft portion 1082C in a plane parallel to the second plane.

[0270] The size of the proximal flange 1082 A in the first plane can be greater than a size of the aperture 1086C of the adhesive sheet 1086 and the size of the aperture 1084C of the wicking material 1084 in respective planes that are parallel to the first plane. Similarly, the size of the distal flange 1082B in the second plane can be greater than a size of the aperture 1086C of the adhesive sheet 1086 and the size of the aperture 1084C of the wicking material 1084 in respective planes that are parallel to the second plane. In this arrangement, the adhesive sheet 1086 and the wicking material 1084 are sandwiched between the proximal flange 1082 A and the distal flange 1082B of the vacuum port 1082.

[0271] Additionally, as shown in Figure 10B, the proximal side 1086A of the adhesive sheet 1086 can extend over the distal side 1084B of the wicking material 1084. As such, the wicking material 1084 can be coupled to the adhesive sheet 1086 by the adhesive on the proximal side 1086A of the adhesive sheet 1086. This can help to secure the wicking material 1084 and the adhesive sheet 1086 to each other, which can assist in handling and coupling the urine diversion device 1010 to the skin of the user.

[0272] The adhesive sheet 1086 can also have a size that is greater than a size of the wicking material 1084 such that a peripheral portion of the adhesive sheet 1086 extends beyond a peripheral edge of the wicking material 1084. In this arrangement, the adhesive of the adhesive sheet 1086 can be exposed at the peripheral portion of the adhesive sheet 1086 so that the adhesive sheet 1086 can couple to the skin of the user.

[0273] In some examples, the peripheral portion of the adhesive sheet 1086 can extend entirely around the wicking material 1084. This can help to provide a fluid-tight seal between the adhesive sheet 1086 and the skin of the user around an entire circumference of the adhesive sheet 1086 (and an entire circumference of the wicking material 1084). This in turn can helpto mitigate (or prevent) leakage of fluid from a space between the user and the proximal side of the urine diversion device 1010 when the urine diversion device 1010 is coupled to the user.

[0274] In some examples, the urine diversion device 1010 can also include a release liner 1090 that can cover the adhesive on the proximal side 1086A of the adhesive sheet 1086. The release liner 1090 can be removed to expose the adhesive prior to coupling the urine diversion device 1010 to the user.

[0275] In use, the release liner 1090 can be removed from the adhesive sheet 1086 to expose the adhesive on the proximal side 1086A of the adhesive sheet 1086. The urine diversion device 1010 can be positioned with the wi eking material 1084 (and / or the proximal flange 1082 A of the vacuum port 1082) aligned with the urethral opening of the user. The adhesive sheet 1086 can be coupled to the skin of the user surrounding the urethra of the user by the adhesive on the adhesive sheet 1086. For instance, the adhesive sheet 1086 can form a seal with the skin around the vacuum port 1082 and the wi eking material 1084. An enclosed space can thus be formed between the proximal side of the urine diversion device 1010 and the skin of the user.

[0276] The connector 1082D of the vacuum port 1082 can be coupled to the vacuum device 116 by the drain tube 112, and the vacuum device 116 can apply the vacuum pressure to the vacuum port 1082. The vacuum port 1082 can propagate the vacuum pressure to the enclosed space. When fluid is discharged from the body of the user, the fluid can be suctioned into the vacuum port 1082 and along the drain tube 112 toward the waste collection receptacle 114. The wicking material 1084 can help to initially wick the fluid away from the user until the vacuum pressure applied in the enclosed space draws the fluid from the wicking material 1084 and into the vacuum port 1082.

[0277] Referring now to Figures 11A-11B, a urine diversion device 1110 is shown according to another example. In particular, Figure 11 A depicts a proximal side of the urine diversion device 1110 and Figure 1 IB depicts a distal side of the urine diversion device 1110, according to the example.

[0278] The urine diversion device 1110 shown in Figures 11A-11B is substantially similar or identical to the urine diversion device 1010 shown in Figures 10A-10B, except the wicking material 1014 covers a proximal end of the vacuum port 1082 and the connector 1082D of the vacuum port 1082 is configured such that the lumen of the vacuum port 1088 has a 90 degree turn instead of being straight. In this example, the adhesive sheet 1086 is coupled tothe vacuum port 1082 as described above. The wicking material 1084 is coupled to the vacuum port 1082 by the adhesive coupling between the wicking material 1084 and the adhesive sheet 1086. With the wicking sheet covering the vacuum port 1082, the vacuum port 1082 can more directly apply the vacuum pressure to the wicking material 1084.

[0279] As described above, the drain tube 112 can couple the urine diversion device 110 (e.g., the urine diversion devices 210, 310, 410, 510, 610, 710, 810, 910, 1010, 1110) to the waste collection receptacle 114. In some examples, the urine diversion device 110 can include an attachment member 1248 that can help to couple the urine diversion device 110 to the user and / or help to maintain a portion of the drain tube 112 in a fixed position relative to the user.

[0280] Figures 12A-12D depict the attachment member 1248 and the drain tube 112, according to an example. Figure 12A depicts the attachment member 1248 at a first position on the drain tube 112, Figure 12B depicts the attachment member 1248 at a second position on the drain tube 112, Figure 12C depicts the attachment member 1248 decoupled from the drain tube 112, and Figure 12D depicts a side view of the attachment member 1248 coupled to the drain tube, according to an example.

[0281] As shown in Figures 12A-12D, the attachment member 1248 includes a first lateral portion 1248 A, a second lateral portion 1248B, an intermediate portion 1248C between the first lateral portion 1248A and the second lateral portion 1248B, and a bridge portion 1248D that extends from the first lateral portion 1248 A to the second lateral portion 1248B and over the intermediate portion 1248C. The first lateral portion 1248A and the second lateral portion 1248B include an adhesive that is configured to couple the attachment member 1248 to the user. In some examples, the intermediate portion 1248C and / or the bridge portion 1248D can also include the adhesive. In other examples, the intermediate portion 1248C and / or the bridge portion 1248D can omit the adhesive.

[0282] The intermediate portion 1248C and the bridge portion 1248D define a channel 1248E that is configured to receive the drain tube 112. As shown in Figures 12A-12B, the drain tube 112 and the attachment member 1248 can be movable relative to each other while the drain tube 112 extends through the channel 1248E. This can help to provide for adjustable positioning of the attachment member 1248 relative to other components of the urine diversion device 110 so that the fit and coupling can be tailored to the particular conditions of a given user.

[0283] In some examples, the channel 1248E and the drain tube 112 can have relative sizes such that a friction force between the channel 1248E and the drain tube 112 can help to inhibit inadvertent movement of the attachment member 1248 relative to the drain tube 112.

[0284] Although the drain tube 112 is removably coupled to the attachment member 1248 in Figures 12A-12D, the drain tube 112 can be non-removably coupled to the attachment member 1248 in other examples. For instance, a stop element can be configured to permit movement of the attachment member 1248 and the drain tube 112 over a defined range of positions, but inhibit (or prevent) decoupling of the attachment member 1248 and the drain tube 112 from each other.

[0285] Figures 13A-13B depict a urine diversion device 1310 including the attachment member 1248 according to one example. Although Figures 13A-13B depict the urine diversion device 1310 as being substantially similar to the urine diversion device 810 shown in Figures 8A-8C, the attachment member 1248 can be included in any other urine diversion device described herein.

[0286] Referring now to Figure 14, a simplified diagram of a urine diversion device 1410 is shown according to another example. As shown in Figure 14, the urine diversion device 1410 includes a liquid-impermeable backing 1424, a user interface 1426 coupled to the liquid- impermeable backing 1424, and a fluid manifold 1442 between the liquid-impermeable backing 1424 and the user interface 1426. In use, when the urine diversion device 1410 is positioned on a user, the user interface 1426 is configured to face towards a user and the liquid- impermeable backing 1424 is configured to face away from the user. As such, the user interface 1426 can be proximal of the liquid-impermeable backing 1424 (e.g., on a proximal side of the liquid-impermeable backing 1424). A distal surface of the liquid-impermeable backing 1424 can be opposite the proximal surface of the liquid-impermeable backing 1424 and face away from the user when the urine diversion device 1410 is positioned on the user.

[0287] As shown in Figure 14, the urine diversion device 1410 also includes an internal cavity 1428 between the fluid manifold 1442 and the liquid-impermeable backing 1424. The urine diversion device 1410 further includes a fluid inlet 1430 that is configured to receive a fluid through at least the user interface 1426 into the internal cavity 1428. The fluid manifold 1442 can include a first aperture 1492A in fluid communication with the internal cavity 1428, a second aperture 1492B that is coupled to a fluid outlet 1436, and one or more conduits 1494 that extend from the first aperture 1492 A to the second aperture 1492B. In thisarrangement, responsive to a vacuum pressure applied to the fluid outlet 1436, the fluid manifold 1442 is configured to evacuate the fluid from the internal cavity 1428, through the first aperture 1492 A, along the one or more conduits 1494, and through second aperture 1492B to the fluid outlet 1436. The fluid can then be diverted from the fluid outlet 1436 along a drain tube to a waste collection receptacle, as described above (e.g., along the drain tube 112 to the waste collection receptacle 114 shown in Figure 1).

[0288] In some examples, the liquid-impermeable backing 1424 can be formed from a material that is waterproof and breathable. This can help to mitigate leakage of fluid through the liquid-impermeable backing 1424 while reducing moisture accumulation in the internal cavity 1428. The backing 766 can additionally or alternatively be a flexible material. This can allow the liquid-impermeable backing 1424 to conform to a shape of an anatomy of the user when the urine diversion device 1410 is positioned on the user. In other examples, the liquid- impermeable backing 1424 can be formed from a substantially rigid material.

[0289] In some examples, the liquid-impermeable backing 1424 can be curved along a longitudinal axis extending between an inferior end of the liquid-impermeable backing 1424 and a superior end of the liquid-impermeable backing 1424. This can additionally or alternatively assist in positioning the urine diversion device 1410 on the user.

[0290] In some examples, the liquid-impermeable backing 1424 can be malleable such that the liquid-impermeable backing 1424 is configured to be manually shaped (e.g., under forces typically applicable by human fingers without the assistance of a machine) prior to, during, or after positioning the urine diversion device 1410 on the user. For instance, the liquid- impermeable backing 1424 can include one or more shape retaining elements coupled to and / or embedded in a base material of the liquid-impermeable backing 1424. As examples, the one or more shape retaining elements can include at least one structure selected from a group consisting of: a metal wire and a plastic material. In some examples, the one or more shape retaining elements can be configured to be made malleable responsive to an external stimulus (e.g., heat, electrical signal, pressure, and light). Forming the liquid-impermeable backing 1424 of a malleable material can beneficially help to adjust a shape of the urine diversion device 1410 according to a particular anatomy of a user on which the urine diversion device 1410 is to be positioned.

[0291] Additionally or alternatively, in implementations in which the liquid- impermeable backing 1424 is malleable and / or flexible, the urine diversion device 1410 can bemanufactured, shipped, and stored in a shape that is more compact (e.g., a straight shape) while allowing the urine diversion device 1410 to be subsequently bent to form a curve that can help to better conform the urine diversion device 1410 to the anatomy of the user.

[0292] In other examples, the liquid-impermeable backing 1424 can be non-malleable. For instance, in some implementations in which the liquid-impermeable backing 1424 is flexible, the liquid-impermeable backing 1424 can be non-malleable to reduce costs, simplify manufacturing, and / or avoid the use of certain malleable materials (e.g., avoid metal materials). In some examples, the shape retaining elements can be coupled to the liquid-impermeable backing 1424 to provide malleability to the urine diversion device 1410.

[0293] In some examples, the liquid-impermeable backing 1424 can be non-malleable and substantially rigid. In such examples, the liquid-impermeable backing 1424 can have a shape and / or a size that is suitable to fit most anatomies of users (e.g., a one-size fits most), and / or the liquid-impermeable backing 1424 can be manufactured with a plurality of different shapes and / or a plurality of different sizes such that a user can select a shape and a size that best fits the user.

[0294] Within examples, the user interface 1426 can be formed from a material that enhances user comfort when positioned against the skin of the user. In some examples, the user interface 1426 can be formed from a material that is soft to touch, breathable, hydrophobic, and / or flexible. As an example, the user interface 1426 can be formed of a foam material and / or a non-woven material (e.g., a jersey material).

[0295] As described above, the fluid inlet 1430 is configured to receive a fluid through at least the user interface 1426 into the internal cavity 1428. In some examples, the fluid inlet 1430 can include an aperture that extends through the user interface 1426. The user interface 1426 can be configured such that the aperture of the user interface 1426 is adjacent to a urethral opening of the user when the urine diversion device 1410 is positioned on the user.

[0296] As shown in Figure 14, the internal cavity 1428 is between the fluid manifold 1442 and the liquid-impermeable backing 1424. For instance, the liquid-impermeable backing 1424 can include a proximal backing surface and a distal backing surface, the fluid manifold 1442 can include a proximal manifold portion and a distal manifold portion, and the internal cavity 1428 can be between the proximal backing surface and the distal manifold portion. In some examples, at least the distal manifold portion can be a liquid impermeable material (e.g., the distal manifold portion can include a film formed from a liquid impermeable material). Inthis way, the distal manifold portion of the fluid manifold 1442 and the proximal backing surface of the liquid-impermeable backing 1424 can define boundaries of the internal cavity 1428, which can help to mitigate leakage of the fluid from the internal cavity 1428.

[0297] Additionally, the first aperture 1492 A of the fluid manifold 1442 can be in the distal manifold portion and the one or more conduits 1494 can be between the distal manifold portion and the proximal manifold portion. In this arrangement, the one or more conduits 1494 can be fluidly separated from the internal cavity 1428 except through the first aperture 1492A. Accordingly, in this arrangement, the fluid manifold 1442 and the one or more conduits 1494 do not extend into the internal cavity 1428.

[0298] In some examples, the fluid manifold 1442 can be formed as a single, monolithic structure. In other examples, the fluid manifold 1442 can be formed from a plurality of sub-components that are coupled to each other. For instance, in one implementation, the fluid manifold 1442 can include a first manifold portion that includes one or more channels that extend between the first aperture 1492 A and the second aperture 1492B, and a second manifold portion can cover the one or more channels to define the one or more conduits 1494. In one example, the first manifold portion can define the proximal manifold portion and the second manifold portion can define the distal manifold portion. In another example, the first manifold portion can define the distal manifold portion and the second manifold portion can define the proximal manifold portion.

[0299] In some examples, the fluid inlet 1430 is configured to receive a fluid through at least the user interface 1426 and the fluid manifold 1442 into the internal cavity 1428. For instance, the fluid manifold 1442 can include an inlet aperture that is aligned the aperture of the user interface at the fluid inlet 1430. As such, when the urine diversion device 1410 is positioned on the user, the inlet aperture of the fluid manifold 1442 and the aperture of the user interface 1426 can be adjacent to a urethral opening of the user to receive the fluid through the user interface 1426 and the fluid manifold 1442 into the internal cavity 1428.

[0300] Figures 15A-15D show an implementation of the urine diversion device 1410 described above for Figure 14, according to one example. In particular, Figure 15A depicts a perspective view of the urine diversion device 1410, Figure 15B depicts a proximal side view of the urine diversion device 1410, Figure 15C depicts an exploded view of the urine diversion device 1410, and Figure 15D depicts a cross-sectional view of the urine diversion device 1410 through a longitudinal axis 1560 shown in Figure 15B, according to the example. Figure 15Dalso includes an enlarged, detailed view of an inferior portion of the cross-section of the urine diversion device 1410 shown in Figure 15D, according to the example.

[0301] As shown in Figures 15A-15D, the urine diversion device 1410 includes the liquid-impermeable backing 1424, the user interface 1426 coupled to the liquid-impermeable backing 1424, the fluid manifold 1442 between the liquid-impermeable backing 1424 and the user interface 1426, the internal cavity 1428 (shown in Figure 15D) between the fluid manifold 1442 and the liquid-impermeable backing 1424, and the fluid inlet 1430 that is configured to receive the fluid through at least the user interface 1426 into the internal cavity 1428. As shown in Figure 15D, the urine diversion device 1410 also includes the internal cavity 1428 between the fluid manifold 1442 and the liquid-impermeable backing 1424. The urine diversion device 1410 further includes the fluid inlet 1430 that is configured to receive the fluid through at least the user interface 1426 into the internal cavity 1428.

[0302] In this arrangement, when the urine diversion device 1410 is positioned on a user, the user interface 1426 is configured to face towards the user and the liquid-impermeable backing 1424 is configured to face away from the user. In particular, the urine diversion device 1410 can be positioned on the user with the fluid inlet 1430 positioned adjacent to the urethral opening of the user. In this position, urine discharged by the user can be received into the internal cavity 1428 through the fluid inlet 1430.

[0303] In the example shown in Figures 15A-15D, the fluid inlet 1430 includes an aperture 1526A in the user interface 1426 and an inlet aperture 1542A in the fluid manifold 1442. The inlet aperture 1542A can be aligned with the aperture 1526A of the user interface 1426 such the fluid inlet 1430 extends entirely through the user interface 1426 and the fluid manifold 1442.

[0304] To assist in directing the fluid into the internal cavity 1428, the user interface 1426 and / or the fluid manifold 1442 can include a gasket 1596 that extends around at least a portion of the fluid inlet 1430. For instance, in Figures 15A-15D, the gasket 1596 has a U- shape that includes a first lateral portion on a first lateral side of the fluid inlet 1430, a second lateral portion on a second lateral side of the fluid inlet 1430, and a curved portion that extends between the first lateral portion and the second lateral portion. The U-shape can help to extend around and / or across a periphery of a vagina and / or a perineum to assist in directing urine through the fluid inlet 1430 and help to reduce or mitigate leakage. As shown in Figures 15A- 15D, the gasket 1596 can extend proximally from the user interface 1426 and / or the fluidmanifold 1442. In one example, the gasket 1596 can have a thickness between approximately 0.125 inches to approximately 0.25 inches.

[0305] Figures 15E-15F depict the fluid manifold 1442 and the fluid outlet 1436 for the urine diversion device 1410 shown in Figures 15A-15D, according to an example. As shown in Figures 15C-15F, the fluid manifold 1442 can include the first aperture 1492A in fluid communication with the internal cavity 1428, the second aperture 1492B that is coupled to a fluid outlet 1436, and one or more conduits 1494 that extend from the first aperture 1492 A to the second aperture 1492B. The first aperture 1492A can be located nearer to an inferior end of the urine diversion device 1410 than the second aperture 1492B, and the second aperture 1492B can be located nearer to a superior end of the urine diversion device 1410 than the first aperture 1492A. In this arrangement, responsive to a vacuum pressure applied to the fluid outlet 1436, the fluid manifold 1442 is configured to evacuate the fluid from the internal cavity 1428, through the first aperture 1492 A, along the one or more conduits 1494, and through second aperture 1492B to the fluid outlet 1436. The fluid can then be diverted from the fluid outlet 1436 along a drain tube to a waste collection receptacle, as described above (e.g., along the drain tube 112 to the waste collection receptacle 114 shown in Figure 1).

[0306] As shown in Figure 15D, the internal cavity 1428 is between the fluid manifold 1442 and the liquid-impermeable backing 1424. For instance, the liquid-impermeable backing 1424 can include a proximal backing surface 1524A and a distal backing surface 1524B, the fluid manifold 1442 can include a proximal manifold portion 1542C and a distal manifold portion 1542B, and the internal cavity 1428 can be between the proximal backing surface 1524A and the distal manifold portion 1542B.

[0307] In this example, the distal manifold portion 1542B and the liquid-impermeable backing 1424 can be a liquid impermeable material. In this way, the distal manifold portion 1542B of the fluid manifold 1442 and the proximal backing surface 1524A of the liquid- impermeable backing 1424 can define boundaries of the internal cavity 1428, which can help to mitigate leakage of the fluid from the internal cavity 1428.

[0308] Additionally, as shown in Figures 15D-15F, the first aperture 1492A of the fluid manifold 1442 can be in the distal manifold portion 1542B and the one or more conduits 1494 can be between the distal manifold portion 1542B and the proximal manifold portion 1542C. In this arrangement, the one or more conduits 1494 can be fluidly separated from the internal cavity 1428 except through the first aperture 1492A. Accordingly, in this arrangement,the fluid manifold 1442 and the one or more conduits 1494 do not extend into the internal cavity 1428.

[0309] In some examples, the distal manifold portion 1542B and the proximal manifold portion 1542C can be integrally formed a single, monolithic structure. In other examples, such as the example shown in Figures 15A-15F, the distal manifold portion 1542B and the proximal manifold portion 1542C can be separate components that are coupled to each other. In this example, the proximal manifold portion 1542C can include one or more channels 1542D that extend between the first aperture 1492A and the second aperture 1492B, and the distal manifold portion 1542B can cover the one or more channels 1542D to define the one or more conduits 1494 (shown in Figure 15F).

[0310] In one example, the proximal manifold portion 1542C, including the one or more channels 1542D, can be formed from a foam material (e.g., a closed-cell foam such as, for instance, polyethylene (PE) foam and / or a cross-linked polyethylene (XLPE) foam). The foam material can help to balance comfort, conformability, and structural support resisting collapse. Also, in an example, the distal manifold portion 1542B can be a membrane formed from a non-permeable material. The membrane of the distal manifold portion 1542B can be bonded to the foam material of the proximal manifold portion 1542C to couple the distal manifold portion 1542B and the proximal manifold portion 1542C to each other in one example.

[0311] As shown in Figure 15F, the one or more conduits 1494 can include a first conduit on a first lateral side of the fluid inlet 1430 and a second conduit on a second lateral side of the fluid inlet 1430. This can provide improved suction performance as compared to alternative examples in which the fluid manifold 1442 includes a single conduit 1494. As shown in Figure 15E, the channel(s) 1542D can include a single continuous channel 1542D that extends in a loop around the fluid inlet 1430 (e.g., at the inlet aperture 1542A). The channel(s) 1542D can also include a chamber 1542E at the second aperture 1492B in the distal manifold portion 1542B. The chamber 1542E can have a larger diameter than the conduits 1494. This can help to provide space for the fluid being simultaneously received at the fluid outlet 1436 from the conduits 1494 on opposing sides of the second aperture 1492B.

[0312] As shown in Figures 15C-15F, the second aperture 1492B can be in the distal manifold portion 1542B. As such, a center axis of the second aperture 1492B can be transverse (e.g., orthogonal) to the longitudinal axis 1560 (shown in Figure 15B) of the urine diversiondevice 1410. In this example, the fluid outlet 1436 can include a suction port 1538 to couple the second aperture 1492B of the fluid manifold 1442 to a whip tube 1540 (or the drain tube 112). In some examples, the whip tube 1540 can have a longitudinal axis that is parallel and / or collinear with the longitudinal axis 1560. In this example, the suction port 1538 can include a 90 degree bend to couple the second aperture 1492B and the whip tube 1540. In other examples, the suction port 1538 can be configured to couple the whip tube 1540 to the second aperture 1492B at an acute angle with respect to the superior end of the urine diversion device 1510 (e.g., an angle that is less than 90 degrees). This can allow the whip tube 1540 to be transverse to the longitudinal axis 1560 and extend in a superior direction, and / or improve fluid flow relative to implementations in which the suction port 1538 includes a 90 degree bend. In other examples, the fluid outlet 1436 can omit the whip tube 1540 and the drain tube 112 can be coupled to the suction port 1538 instead of the whip tube 1540.

[0313] As described above and as shown in Figure 15D, the internal cavity 1428 can be between the proximal backing surface 1524A and the distal manifold portion 1542B. As shown in Figures 15C-15D, in some examples, the urine diversion device 1410 can include one or more layers of a wicking material 1570A-1570B in the internal cavity 1428. As examples, the one or more layers of wicking material 1570A-1570B can be formed from a low-density non-woven material such as, for instance, polyester and / or nylon.

[0314] In Figures 15C-15D, the one or more layers of wicking material 1570A-1570B can include a distal layer of wicking material 1570A and a proximal layer of wicking material 1570B. The proximal layer of wicking material 1570B can include an aperture 1570C that is aligned with the fluid inlet 1430 (e.g., aligned with the aperture 1526A and the inlet aperture 1542A). As shown in Figures 15C-15D, the aperture 1570C of the proximal layer of wicking material 1570B can extend to a point that is inferior of the first aperture 1492A. This can provide for an unobstructed path in the internal cavity 1428 from the fluid inlet 1430 to the first aperture 1492 A, which can help to more rapidly evacuate the fluid from the internal cavity 1428.

[0315] The distal layer of wicking material 1570A can be spaced distally of the fluid inlet 1430 (e.g., via the proximal layer of the wicking material 1570B) and extend across the fluid inlet 1430. In this arrangement, the distal layer of wicking material 1570A can help to reduce (or eliminate) splash-back and help to retain loose fluid before immediate evacuation. In some examples, the urine diversion device 1410 can also include a spacer 1598 between the fluid manifold 1442 and the liquid-impermeable backing 1424 to help provide a greaterunobstructed path in the internal cavity 1428 from the fluid inlet 1430. For instance, the spacer 1598 can include an aperture 1598A that extends from the fluid inlet 1430 to a point that is inferior of the first aperture 1492A to assist in providing space for the fluid to flow down from the fluid inlet 1430 to the first aperture 1492A of the fluid manifold 1442. Additionally, as shown in Figure 15C, the spacer 1598 can help to position the distal layer of wi eking material 1570A at a greater distance distally from the fluid inlet 1430 and / or the spacer 1598 can help to temporarily absorb excess fluid in the internal cavity 1428. In one example, the spacer 1598 can be formed from a foam material (e.g., an open-cell foam such as, for instance, reticulated polyurethane foam) and / or the spacer 1598 can have a thickness of approximately 0.125 inches. In other examples, the spacer 1598 can be omitted.

[0316] As shown in Figure 15C, the urine diversion device 1410 can also include a hydrophobic top sheet 1599 that is between the distal layer of wi eking material 1570A and the proximal layer of wicking material 1570B. The hydrophobic top sheet 1599 can help to separate a skin of the user from wetness in the internal cavity 1428. As examples, the hydrophobic top sheet 1599 can be formed from a hydrophobic, non-woven material such as, for instance, polypropylene and / or polyester.

[0317] Additionally, as shown in Figure 15C, the urine diversion device 1410 includes a shape retaining element 1501 in the internal cavity 1428. In some examples, the shape retaining element 1501 can include a wire 1501A embedded in the liquid-impermeable backing 1524. In the example shown in Figure 15C, the shape retaining element 1501 includes a wire 1501A that is coupled to the liquid-impermeable backing 1424 by at least one membrane 1501B. For instance, the wire 1501A can be a U-shaped wire including a first longitudinal portion, a second longitudinal portion, and a curved portion between the first longitudinal portion and the second longitudinal portion. The wire 1501 A can be a non-ferrous such as, for instance, aluminum and / or copper. The membrane(s) 150 IB can be formed from an abrasion and / or puncture-resistant material to mitigate the wire 1501A puncturing through the membrane(s) 150 IB.

[0318] In one example, the urine diversion device 1410 can have one more of the following dimensions: (i) the urine diversion device 1410 can have a thickness (e.g., in a dimension between the liquid-impermeable backing 1424 and the user interface 1426) of approximately 15.5 millimeters, (ii) the urine diversion device 1410 can have a length (e.g., in a dimension between a superior end and an inferior end) of approximately 200 millimeters, (iii) the fluid inlet 1430 can have a height of approximately 80.6 millimeters, and / or (iii) the fluidinlet 1430 can have a width (e.g., in a dimension between a first lateral side and a second lateral side) of approximately 44.5 millimeters. As shown in Figures 15A-15D, the urine diversion device 1410 can have a substantially hourglass shape in which a width of the urine diversion device tapers inwardly from a superior end toward the fluid inlet 1430, and tapers outwardly from the fluid inlet 1430 toward an inferior end. In an example, the urine diversion device 1410 can have a width of approximately 70 millimeters at a narrowest point along the length of the urine diversion device 1410. In another example, the urine diversion device 1410 can have a width of approximately 60 millimeters at a narrowest point along the length of the urine diversion device 1410, and the fluid inlet 1430 can have a width of approximately 40 millimeters. The urine diversion device 1410 can have other shapes and / or sizes in other examples.

[0319] Figures 15A-15F depict one example implementation of the urine diversion device 1410 shown in Figure 14. In other examples, one or more components of the urine diversion device 1410 shown in Figures 15A-15F can be omitted and / or two or more of the components of the urine diversion device 1410 shown in Figures 15A-15F can be combined. For instance, in another implementation, the user interface 1426 and the proximal manifold portion 1542C of the fluid manifold 1442 can be combined. As another example, in another implementation, one or more of the proximal layer of wicking material 1570B, the spacer 1598, the hydrophobic top sheet 1599, or the distal layer of wicking material 1570A can be omitted. Other example implementations that combine or omit features shown in Figures 15A-15F are also possible. Also, in other examples, the urine diversion device 1410 can further include an attachment member (e.g., the attachment member 1248 shown in Figures 12A-13B).

[0320] In use, the urine diversion device 1410 is positioned on the user with the fluid inlet 1430 adjacent to a urethral opening of the user. After the urine diversion device 1410 is positioned on the user, the urine diversion device 1410 can receive the fluid (e.g., urine) from the user through the fluid inlet 1430 and into the internal cavity 1428. The fluid can move in an inferior direction from the fluid inlet 1430 toward the first aperture 1492 A of the fluid manifold 1442.

[0321] When a vacuum pressure is applied to the fluid outlet 1436 (e.g., by the vacuum device 116 via the air tube 122 and the drain tube 112), the vacuum pressure can propagate through the conduits 1494 of the fluid manifold 1442 to the first aperture 1492 A. With the assistance of the vacuum pressure, the fluid can be egressed from the internal cavity 1428 through the first aperture 1492 A, along the conduits 1494, through the second aperture 1492B,and out the fluid outlet 1436 to the drain tube 112 and the waste collection receptacle 114. Within examples, the vacuum pressure applied to the fluid manifold 1442 can direct the fluid along this this flow pathway and against the force of gravity.

[0322] In the examples shown in Figures 14-15F, the urine diversion device 1410 includes the internal cavity 1428 between the fluid manifold 1442 and the liquid-impermeable backing 1424. However, in other examples, the urine diversion device 1410 can include the internal cavity 1428 between the fluid manifold 1442 and the user interface 1426. Figure 16 depicts a simplified diagram of a urine diversion device 1610 according to another example. The urine diversion device 1610 is substantially similar or identical to the urine diversion device 1410 described above with respect to Figures 14-15F, except the urine diversion device 1610 includes the internal cavity 1428 between the fluid manifold 1442 and the user interface 1426.

[0323] As shown in Figure 16, the urine diversion device 1610 includes the liquid- impermeable backing 1424, the user interface 1426 coupled to the liquid-impermeable backing 1424, and the fluid manifold 1442 between the liquid-impermeable backing 1424 and the user interface 1426. Additionally, as shown in Figure 16, the urine diversion device 1610 also includes the internal cavity 1428 between the fluid manifold 1442 and the user interface 1426. The urine diversion device 1610 further includes the fluid inlet 1430 that is configured to receive the fluid through the user interface 1426 into the internal cavity 1428. The fluid manifold 1442 can include the first aperture 1492 A in fluid communication with the internal cavity 1428, the second aperture 1492B that is coupled to the fluid outlet 1436, and the one or more conduits 1494 that extend from the first aperture 1492 A to the second aperture 1492B. The first aperture 1492 A can be located nearer to an inferior end of the urine diversion device 1610 than the second aperture 1492B, and the second aperture 1492B can be located nearer to a superior end of the urine diversion device 1610 than the first aperture 1492A. In this arrangement, responsive to a vacuum pressure applied to the fluid outlet 1436, the fluid manifold 1442 is configured to evacuate the fluid from the internal cavity 1428, through the first aperture 1492 A, along the one or more conduits 1494, and through second aperture 1492B to the fluid outlet 1436. The fluid can then be diverted from the fluid outlet 1436 along a drain tube to a waste collection receptacle, as described above (e.g., along the drain tube 112 to the waste collection receptacle 114 shown in Figure 1).

[0324] As shown in Figure 16, the internal cavity 1428 is between the fluid manifold 1442 and the user interface 1426. For instance, the user interface 1426 can include a distalsurface, the fluid manifold 1442 can include a proximal manifold portion and a distal manifold portion, and the internal cavity 1428 can between the distal surface of the user interface 1426 and the distal manifold portion. In some examples, at least the proximal manifold portion can be a liquid impermeable material. In this way, the proximal manifold portion of the fluid manifold 1442 and the distal surface of the user interface 1426 can define boundaries of the internal cavity 1428, which can help to mitigate leakage of the fluid from the internal cavity 1428.

[0325] Additionally, the first aperture 1492 A of the fluid manifold 1442 can be in the proximal manifold portion and the one or more conduits 1494 can be between the distal manifold portion and the proximal manifold portion. In this arrangement, the one or more conduits 1494 can be fluidly separated from the internal cavity 1428 except through the first aperture 1492A. Accordingly, in this arrangement, the fluid manifold 1442 and the one or more conduits 1494 do not extend into the internal cavity 1428.

[0326] As described above, in some examples, the fluid manifold 1442 can be formed as a single, monolithic structure. In other examples, the fluid manifold 1442 can be formed from a plurality of sub-components that are coupled to each other. For instance, in one implementation, the fluid manifold 1442 can include a first manifold portion that includes one or more channels that extend between the first aperture 1492A and the second aperture 1492B, and a second manifold portion can cover the one or more channels to define the one or more conduits 1494. In one example, the first manifold portion can define the proximal manifold portion and the second manifold portion can define the distal manifold portion. In another example, the first manifold portion can define the distal manifold portion and the second manifold portion can define the proximal manifold portion.

[0327] Figures 17A-17E show an implementation of the urine diversion device 1610, according to an example. In particular, Figure 17A depicts a proximal side view of the urine diversion device 1610, Figure 17B depicts a distal side view of the urine diversion device 1610, and Figure 17C depicts an exploded view of the urine diversion device 1610, according to the example.

[0328] As shown in Figures 17A-17C, the urine diversion device 1610 includes the liquid-impermeable backing 1424, the user interface 1426 coupled to the liquid-impermeable backing 1424, the fluid manifold 1442 between the liquid-impermeable backing 1424 and the user interface 1426, the internal cavity 1428 between the fluid manifold 1442 and the userinterface 1426, and the fluid inlet 1430 that is configured to receive the fluid through the user interface 1426 into the internal cavity 1428. In this arrangement, when the urine diversion device 1610 is positioned on a user, the user interface 1426 is configured to face towards the user and the liquid-impermeable backing 1424 is configured to face away from the user. In particular, the urine diversion device 1610 can be positioned on the user with the fluid inlet 1430 positioned adjacent to the urethral opening of the user. In this position, urine discharged by the user can be received into the internal cavity 1428 through the fluid inlet 1430.

[0329] To assist in directing the fluid into the internal cavity 1428, the user interface 1426 can include the gasket 1596 that extends around at least a portion of the fluid inlet 1430. For instance, in Figures 17A and 17C, the gasket 1596 has a U-shape that includes a first lateral portion on a first lateral side of the fluid inlet 1430, a second lateral portion on a second lateral side of the fluid inlet 1430, and a curved portion that extends between the first lateral portion and the second lateral portion. The U-shape can help to extend around and / or across a periphery of a vagina and / or a perineum to assist in directing urine through the fluid inlet 1430 and help to reduce or mitigate leakage. As shown in Figures 17A and 17C, the gasket 1596 can extend proximally from the user interface 1426. In one example, the gasket 1596 can have a thickness between approximately 0.125 inches to approximately 0.25 inches.

[0330] Figures 17D-17E depict the fluid manifold 1442 and the fluid outlet 1436 for the urine diversion device 1610 shown in Figures 17A-17C, according to an example. As shown in Figures 17C-17E, the fluid manifold 1442 can include the first aperture 1492A in fluid communication with the internal cavity 1428, the second aperture 1492B that is coupled to a fluid outlet 1436, and one or more conduits 1494 that extend from the first aperture 1492 A to the second aperture 1492B. In this arrangement, responsive to a vacuum pressure applied to the fluid outlet 1436, the fluid manifold 1442 is configured to evacuate the fluid from the internal cavity 1428, through the first aperture 1492 A, along the one or more conduits 1494, and through second aperture 1492B to the fluid outlet 1436. The fluid can then be diverted from the fluid outlet 1436 along a drain tube to a waste collection receptacle, as described above (e.g., along the drain tube 112 to the waste collection receptacle 114 shown in Figure 1).

[0331] In the example shown in Figures 17D-17E, the first aperture 1492A of the fluid manifold 1442 can be in a proximal manifold portion 1742 A and the one or more conduits 1494 can be between a distal manifold portion 1742B and the proximal manifold portion 1742A. In this arrangement, the one or more conduits 1494 can be fluidly separated from the internal cavity 1428 except through the first aperture 1492A. Accordingly, in this arrangement, thefluid manifold 1442 and the one or more conduits 1494 do not extend into the internal cavity 1428.

[0332] In some examples, the distal manifold portion 1742B and the proximal manifold portion 1742A can be integrally formed a single, monolithic structure. In other examples, such as the example shown in Figures 17D-17E, the distal manifold portion 1742B and the proximal manifold portion 1742 A can be separate components that are coupled to each other. In this example, the distal manifold portion 1742B can include one or more channels 1742C that extend between the first aperture 1492 A and the second aperture 1492B, and the proximal manifold portion 1742A can cover the one or more channels 1742C to define the one or more conduits 1494 (shown in Figure 17E). In other examples, the proximal manifold portion 1742A can include the one or more channels 1742C and the distal manifold portion 1742B can cover the one or more channels 1742C to define the one or more conduits 1494.

[0333] In one example, the distal manifold portion 1742B, including the one or more channels 1742C, can be formed from a foam material (e.g., a closed-cell foam such as, for instance, polyethylene (PE) foam and / or a cross-linked polyethylene (XLPE) foam). The foam material can help to balance comfort, conformability, and structural support resisting collapse. Also, in an example, the proximal manifold portion 1742A can be a membrane formed from a non-permeable material. The membrane of the proximal manifold portion 1742 A can be bonded to the foam material of the distal manifold portion 1742B to couple the proximal manifold portion 1742A and the distal manifold portion 1742B to each other in one example.

[0334] As shown in Figure 17D, the one or more conduits 1494 can include a first conduit on a first lateral side of the fluid inlet 1430 and a second conduit on a second lateral side of the fluid inlet 1430. This can provide improved suction performance as compared to alternative examples in which the fluid manifold 1442 includes a single conduit 1494. As shown in Figure 15E, the channel(s) 1542D can include a single continuous channel 1542D that extends in a loop around the fluid inlet 1430 (e.g., at the inlet aperture 1542A).

[0335] As shown in Figures 17D-17E, the second aperture 1492B can be in the distal manifold portion 1742B. As such, a center axis of the second aperture 1492B can be transverse (e.g., orthogonal) to the longitudinal axis 1560 (shown in Figure 17A) of the urine diversion device 1610. In this example, the fluid outlet 1436 can include the suction port 1538 to couple the second aperture 1492B of the fluid manifold 1442 to the whip tube 1540 (or the drain tube 112). In some examples, the whip tube 1540 can have a longitudinal axis that is parallel and / orcollinear with the longitudinal axis 1560. In this example, the suction port 1538 can include a 90 degree bend to couple the second aperture 1492B and the whip tube 1540. In other examples, the suction port 1538 can be configured to couple the whip tube 1540 to the second aperture 1492B at an acute angle with respect to the superior end of the urine diversion device 1710. This can allow the whip tube 1540 to be transverse to the longitudinal axis 1560 and extend in a superior direction, and / or improve fluid flow relative to implementations in which the suction port 1538 includes a 90 degree bend. In other examples, the fluid outlet 1436 can omit the whip tube 1540 and the drain tube 112 can be coupled to the suction port 1538 instead of the whip tube 1540.

[0336] As shown in Figures 17C-17E, the suction port 1538 can be coupled to a distal side of the liquid-impermeable backing 1424. The liquid-impermeable backing 1424 can include an aperture 1724A to fluidly couple the fluid outlet 1436 (e.g., the suction port 1538) to the second aperture 1492B of the fluid manifold 1442. Accordingly, the suction port 1538, the aperture 1724 A in the liquid-impermeable backing 1424, and the second aperture 1492B of the fluid manifold 1442 can be aligned with each other to fluidly couple the fluid manifold 1442 and the fluid outlet 1436.

[0337] Additionally, as shown in Figures 17C-17D, the urine diversion device 1610 can also the shape retaining element 1501. In some examples, the shape retaining element 1501 can include a wire and / or a plate of a malleable material such as, for instance, a nonferrous metal (e.g., aluminum and / or copper). In the example shown in Figure 17C-17D, the shape retaining element 1501 is a wire in a shape of a loop. In this shape, the wire has no ends, which reduces a possibility that the wire may pierce through the urine diversion device 1610 and become exposed. Additionally, as shown in Figure 17C-17D, the shape retaining element 1501 can be coupled to the fluid manifold 1442. For instance, the fluid manifold 1442 can include one or more recesses 1742D that can receive the shape retaining element 1501. In Figure 17D, the distal manifold portion 1742B includes the recess(s) 1742D on a proximal surface, and the proximal manifold portion 1742 A covers and encloses the shape retaining element 1501 in the recess(es) 1742D when the proximal manifold portion 1742A is coupled to the distal manifold portion 1742B.

[0338] As shown in Figure 17C, in some examples, the urine diversion device 1610 can include a wicking material 1570 in the internal cavity 1428 between the fluid manifold 1442 and the user interface 1426. As examples, the wicking material 1570 can be formed from a low-density non-woven material such as, for instance, polyester and / or nylon.

[0339] In some examples, the wi eking material 1570 can include an aperture 1770A that is aligned with the first aperture 1492A of the fluid manifold 1442. This can provide for an unobstructed path in the internal cavity 1428 from the fluid inlet 1430 to the first aperture 1492A, which can help to more rapidly evacuate the fluid from the internal cavity 1428. Additionally, a portion of the wi eking material 1570 can be spaced distally of the fluid inlet 1430 (e.g., via the spacer 1598) and extend across the fluid inlet 1430. In this arrangement, the wi eking material 1570 can help to reduce (or eliminate) splash-back and help to retain loose fluid before immediate evacuation.

[0340] As described above, the spacer 1598 can include the aperture 1598 A that extends from the fluid inlet 1430 to a point that is inferior of the first aperture 1492A to assist in providing space for the fluid to flow down from the fluid inlet 1430 to the first aperture 1492A of the fluid manifold 1442. Additionally, as shown in Figure 17C, the spacer 1598 can help to position the wi eking material 1570 at a greater distance distally from the fluid inlet 1430 and / or the spacer 1598 can help to temporarily absorb excess fluid in the internal cavity 1428. In one example, the spacer 1598 can be formed from a foam material and / or the spacer1598 can have a thickness of approximately 0.125 inches. In other examples, the spacer 1598 can be omitted.

[0341] As shown in Figure 17C, the urine diversion device 1610 can also include the hydrophobic top sheet 1599 that is between the wi eking material 1570 and the spacer 1598 and / or the user interface 1426. The hydrophobic top sheet 1599 can help to separate a skin of the user from wetness in the internal cavity 1428. As examples, the hydrophobic top sheet1599 can be formed from a hydrophobic, non-woven material such as, for instance, polypropylene and / or polyester.

[0342] Additionally, in Figure 17C, the user interface 1426 includes a proximal interface layer 1726A, a gasket layer 1726B, and / or a distal interface layer 1726C. The proximal interface layer 1726A can include one or more materials that can enhance user comfort. The gasket layer 1726B can include a foam material that can help to provide a structural support to the user interface 1426 and / or the gasket 1596. The proximal interface layer 1726A can be formed of a liquid impermeable material to assist in providing a fluid barrier that defines, at least in part, a proximal boundary of the internal cavity 1428. For instance, the proximal interface layer 1726A can include a film that is formed from a liquid impermeable material. As shown in Figures 17A-17C, the fluid inlet 1430 can be defined by respective apertures of the proximal interface layer 1726A, the gasket layer 1726B, and / or thedistal interface layer 1726C.

[0343] In one example, the urine diversion device 1610 can have one more of the following dimensions: (i) the urine diversion device 1610 can have a thickness (e.g., in a dimension between the liquid-impermeable backing 1424 and the user interface 1426) of approximately 15.5 millimeters, (ii) the urine diversion device 1610 can have a length (e.g., in a dimension between a superior end and an inferior end) of approximately 200 millimeters, (iii) the fluid inlet 1430 can have a height of approximately 80.6 millimeters, (iv) the fluid inlet 1430 can have a width (e.g., in a dimension between a first lateral side and a second lateral side) of approximately 44.5 millimeters. As shown in Figures 17A-17C, the urine diversion device 1610 can have a substantially hourglass shape in which a width of the urine diversion device tapers inwardly from a superior end toward the fluid inlet 1430, and tapers outwardly from the fluid inlet 1430 toward an inferior end. In an example, the urine diversion device 1610 can have a width of approximately 70 millimeters at a narrowest point along the length of the urine diversion device 1610. In another example, the urine diversion device 1610 can have a width of approximately 60 millimeters at a narrowest point along the length of the urine diversion device 1610, and the fluid inlet 1430 can have a width of approximately 40 millimeters. The urine diversion device 1610 can have other shapes and / or sizes in other examples.

[0344] Figures 17A-17E depict one example implementation of the urine diversion device 1610 shown in Figure 16. In other examples, one or more components of the urine diversion device 1610 shown in Figures 17A-17E can be omitted and / or two or more of the components of the urine diversion device 1610 shown in Figures 17A-17E can be combined. For instance, in another implementation, the liquid-impermeable backing 1424 and the distal manifold portion 1742B of the fluid manifold 1442 can be combined. As another example, in another implementation, one or more of the wicking material 1570, the spacer 1598, and / or the hydrophobic top sheet 1599 can be omitted. In another example, one or more of the proximal interface layer 1726A, the gasket layer 1726B, and / or the distal interface layer 1726C can be omitted or combined with each other. Other example implementations that combine or omit features shown in Figures 17A-17E are also possible. Also, in other examples, the urine diversion device 1610 can further include an attachment member (e.g., the attachment member 1248 shown in Figures 12A-13B).

[0345] In use, the urine diversion device 1610 is positioned on the user with the fluid inlet 1430 adjacent to a urethral opening of the user. After the urine diversion device 1610 ispositioned on the user, the urine diversion device 1610 can receive the fluid (e.g., urine) from the user through the fluid inlet 1430 and into the internal cavity 1428. The fluid can move in an inferior direction from the fluid inlet 1430 toward the first aperture 1492 A of the fluid manifold 1442.

[0346] When a vacuum pressure is applied to the fluid outlet 1436 (e.g., by the vacuum device 116 via the air tube 122 and the drain tube 112), the vacuum pressure can propagate through the conduits 1494 of the fluid manifold 1442 to the first aperture 1492 A. With the assistance of the vacuum pressure, the fluid can be egressed from the internal cavity 1428 through the first aperture 1492 A, along the conduits 1494, through the second aperture 1492B, and out the fluid outlet 1436 to the drain tube 112 and the waste collection receptacle 114. Within examples, the vacuum pressure applied to the fluid manifold 1442 can direct the fluid along this this flow pathway and against the force of gravity.

[0347] Figures 18A-18B depict the fluid manifold 1442 and the shape retaining element 1501 for the urine diversion device 1610 shown in Figures 17A-17C, according to other examples. In Figure 18 A, the recess(es) 1742D are on a distal side of the distal manifold portion 1742B instead of on a proximal side of the distal manifold portion 1742B as shown in Figure 17D-17E. In this example, the liquid-impermeable backing 1424 covers and encloses the shape retaining element 1501. In Figure 18B, the shape retaining element 1501 is entirely embedded within the distal manifold portion 1742B. For instance, the shape retaining element 1501 can be positioned between two layers of foam prior to coupling the two layers of foam to each other (e.g., via pressure forming).

[0348] Figure 19 depicts the fluid manifold 1442 and the liquid-impermeable backing 1424 for the urine diversion device 1610 shown in Figures 17A-17C, according to another example. In Figure 19, the fluid manifold 1442 includes the channel(s) 1742C on a distal side of the fluid manifold 1442, and the first aperture 1492 A extends through the fluid manifold 1442 from the distal side to a proximal side of the fluid manifold 1442. The liquid- impermeable backing 1424 covers the channel(s) 1742C to define the conduit(s) 1494 (shown in Figure 17E), and the aperture 1724A of the liquid-impermeable backing 1424 defines the second aperture of the fluid manifold 1442. In this arrangement, the fluid in the internal cavity 1428 can pass through the fluid manifold 1442 from the proximal side to the distal side, into the conduit(s) 1494 defined by the channel(s) 1742C and the liquid-impermeable backing 1424, through the aperture 1724 A of the liquid-impermeable backing 1424, and into the fluid outlet 1436.

[0349] In Figures 17C-19, the liquid-impermeable backing 1424 is depicted as a generally planar structure that can be coupled to the user interface 1426. However, in other examples, the liquid-impermeable backing 1424 can have three dimensional shape that can help to (i) facilitate assembly of the components of the urine diversion device 1610, (ii) increase a volume of the internal cavity 1428, and / or (iii) provide more rounded lateral edges that can improve user comfort.

[0350] As an example, Figures 20A-20C depict a urine diversion device 2010 as another implementation of the urine diversion device 1610 shown and described above with respect to Figures 16-17E, according to another example. Figure 20A shows a proximal side view of the urine diversion device 2010, Figure 20B shows a lateral side view of an inferior portion of the urine diversion device 2010, and Figure 20C depicts a cross-sectional view of the urine diversion device 2010, according to the example.

[0351] As shown in Figures 20A-20C, the urine diversion device 2010 include a proximal side 2010A, a distal side 2010B, and one or more lateral walls 2010C that extend between the proximal side 2010A and the distal side 2010B. In this example, the user interface 1426 defines the proximal side 2010 A, and the liquid-impermeable backing 1424 defines the distal side 2010B and the one or more lateral walls 2010C. The liquid-impermeable backing 1424 can define a receptacle that is enclosed on all sides, except the proximal side 2010A. For instance, in one implementation, the liquid-impermeable backing 1424 can be vacuumed formed to provide the liquid-impermeable backing 1424 in the receptacle shape prior to assembly.

[0352] As shown in Figures 20B-20C, the liquid-impermeable backing 1424 can further include an upper peripheral edge 2025 that can define a flange that can extend outwardly in a plane away from lateral wall(s) 2010C. The flange can help to increase a surface area for coupling the liquid-impermeable backing 1424 to the user interface 1426. Additionally, as shown in Figure 20A, the flange can allow the urine diversion device 2010 to have no weld or seam along the user interface 1426 (which contacts the user). This can enhance user comfort.

[0353] In some examples, the user interface 1426 can be coupled to the liquid- impermeable backing 1424 by at least one coupling process selected from a group consisting of: lamination, radiofrequency (RF) seal, and impulse seal. When a foam of the user interface 1426 is coupled to the liquid-impermeable backing 1424 by a RF seal, a weld can go through the foam of the user interface 1426. This may leave a small impression, which can then be cutoff. By contrast, when a foam of the user interface 1426 is coupled to the liquid-impermeable backing 1424 by an impulse seal, the weld may not go through the foam of the user interface 1426. It may be beneficial to use an impulse welding fixture for such implementations.

[0354] In the example shown in Figures 20A-20C, a proximal-most layer of the user interface 1426 (e.g., the proximal interface layer 1726A shown in Figure 17C) can extend continuously over an entirety of the proximal side 2010A of the urine diversion device 2010. In this implementation, the fluid inlet 1430 is defined by one or more layers of the user interface 1426 that are distal of the proximal-most layer of the user interface 1426 (e.g., the gasket layer 1726B and / or the distal interface layer 1726C shown in Figure 17C). This configuration of the user interface 1426 can help to improve user comfort and / or assist in retaining one or more components of the urine diversion device 1610 within an enclosed space between the user interface 1426 and the liquid-impermeable backing 1424. However, in other implementations, the fluid inlet 1430 can extend entirely through the user interface 1426, and the spacer 1598 can define a recess extending from the fluid inlet 1430 into the internal cavity 1428. This may be beneficial in implementations in which the urine diversion device 2010 is used by a user with a micro-penis or a retracted penis.

[0355] As shown in Figure 20C, the urine diversion device 2010 includes the spacer 1598 between the fluid manifold 1442 and the user interface 1426. The fluid manifold 1442 includes the conduit(s) 1494 and the recess(es) 1724D for the shape retaining element 1501. In this example, the spacer 1598 is a liquid distribution layer or spacer fabric such as, for example, a three-dimensional mesh material sold by Muller Textil GMBH of Wiehl- Dravenderhoehe, Germany and / or a material described in International Publication No. W02014102072 filed on December 13, 2013, the contents of which is hereby incorporated by reference in its entirety.

[0356] In some implementations, the spacer 1598 can include the aperture 1570C shown in Figures 15C and 17C. In other implementations (e.g., such as the implementation shown in Figures 20A-20), the spacer 1598 can omit the aperture 1570C. This can be beneficial in such implementations in which the spacer 1598 can beneficially help to reduce splash back when urine contacts the spacer 1598.

[0357] In Figure 20C, the lateral wall(s) 2010C are approximately orthogonal to the distal side 2010B of the urine diversion device 2010. In other examples, the lateral wall(s) 2010C can be curved or rounded between the distal side 2010B and the upper peripheral edge2025. This may help to improve user comfort.

[0358] Figures 21A-21H depict a urine diversion device 2110 as another implementation of the urine diversion device 1410, 1610, 2010 shown and described above with respect to Figures 14-20C, according to another example. Figure 21A shows a first perspective view of the urine diversion device 2110, Figure 21B shows a second perspective view of the urine diversion device 2110, Figure 21C shows a proximal side view of the urine diversion device 2110, Figure 2 ID shows a distal side view of the urine diversion device 2110, Figure 21E shows an exploded view of the urine diversion device 2110, Figure 21F shows a cross-sectional view of the urine diversion device 2110 through a longitudinal axis 2160 shown in Figure 21C, Figure 21G shows an enlarged view of a portion of the urine diversion device 2110 shown in Figure 21F, and Figure 21H depicts a partial assembly view of the urine diversion device 2110, according to the example.

[0359] As shown in Figures 21A-21G, the urine diversion device 2110 includes the liquid-impermeable backing 1424, the user interface 1426 coupled to the liquid-impermeable backing 1424, the fluid manifold 1442 between the liquid-impermeable backing 1424 and the user interface 1426, the internal cavity 1428 between the fluid manifold 1442 and the user interface 1426, and the fluid inlet 1430 that is configured to receive the fluid through the user interface 1426 into the internal cavity 1428. In this arrangement, when the urine diversion device 2110 is positioned on a user, the user interface 1426 is configured to face towards the user and the liquid-impermeable backing 1424 is configured to face away from the user. In particular, the urine diversion device 2110 can be positioned on the user with the fluid inlet 1430 positioned adjacent to the urethral opening of the user. In this position, urine discharged by the user can be received into the internal cavity 1428 through the fluid inlet 1430.

[0360] In the example shown in Figures 21A-21G, the user interface 1426 includes a proximal interface layer 2126A and a support layer 2126B distal of the proximal interface layer 2126A. The proximal interface layer 2126A can include one or more materials that can enhance user comfort. The support layer 2126B can be configured to provide a structural support to the user interface 1426. For example, the support layer 2126B can be formed from a foam material (e.g., a cross-linked polyethylene foam (XLPE) with an ethylene vinyl acetate (EVA) copolymer, which is also known as 4EO foam). Within examples, the support layer 2126B can be formed of a liquid impermeable material to assist in providing a fluid barrier that defines, at least in part, a proximal boundary of the internal cavity 1428.

[0361] As shown in Figure 21E, the proximal interface layer 2126A can extend continuously over an entirety of a proximal side 2110A of the urine diversion device 2010 (shown in Figure 21F). In this implementation, the support layer 2126B includes an aperture that defines the fluid inlet 1430 of the urine diversion device 2110 as shown in Figure 21E. This configuration of the user interface 1426 can help to improve user comfort and / or assist in retaining one or more components of the urine diversion device 2110 within an enclosed space between the user interface 1426 and the liquid-impermeable backing 1424. However, in other implementations, the proximal interface layer 2126A can also include an aperture that forms at least a part of the fluid inlet 1430, and a spacer 2198 can define a recess (e.g., a concavity) extending from the fluid inlet 1430 into the internal cavity 1428 and / or an aperture (e.g., the aperture 1598 A described above). This may be beneficial in implementations in which the urine diversion device 2110 is used by a user with a micro-penis or a retracted penis.

[0362] As shown in Figure 21E, the proximal interface layer 2126A and / or the support layer 2126B of the user interface 1426 can have rounded edges at a superior end and / or rounded edges at an inferior end of the user interface 1426. This can help to improve user comfort when positioned on the user (e.g., between the thighs of the user).

[0363] As shown in Figures 21E-21G, the urine diversion device 2110 can also include a spacer 2198 between the user interface 1426 and the fluid manifold 1442 to help receive and divert urine received into the internal cavity 1428 from the fluid inlet 1430. In one example, the spacer 1598 can be formed from a foam material and / or the spacer 1598 can have a thickness of approximately 0.125 inches. In the example shown in Figures 21E-21G, the spacer 2198 omits the aperture 1598 A of the spacer 1598 shown in Figure 17C. However, as described above, the spacer 2198 can include the aperture 1598 A and / or a concavity in other examples (e.g., to accommodate male anatomy in some implementations).

[0364] As shown in Figures 21E-21G, the fluid manifold 1442 is between the spacer 2198 and the liquid-impermeable backing 1424. The fluid manifold 1442 can be configured as described above with respect to Figures 17D-20C. For instance, as shown in Figure 21H, the fluid manifold 1442 can include the first aperture 1492 A in fluid communication with the internal cavity 1428, the second aperture 1492B that is coupled to a fluid outlet 1436, and one or more conduits 1494 that extend from the first aperture 1492 A to the second aperture 1492B. In this arrangement, responsive to a vacuum pressure applied to the fluid outlet 1436, the fluid manifold 1442 is configured to evacuate the fluid from the internal cavity 1428, through the first aperture 1492 A, along the one or more conduits 1494, and through second aperture 1492Bto the fluid outlet 1436. The fluid can then be diverted from the fluid outlet 1436 along a drain tube to a waste collection receptacle, as described above (e.g., along the drain tube 112 to the waste collection receptacle 114 shown in Figure 1).

[0365] In the example shown in Figures 21 A-21H, the first aperture 1492A of the fluid manifold 1442 can be in a proximal manifold portion 2142 A and the one or more conduits 1494 can be between a distal manifold portion 2142B and the proximal manifold portion 2142A (e.g., as described above and shown with respect to Figures 17A-17E). In this arrangement, the one or more conduits 1494 can be fluidly separated from the internal cavity 1428 except through the first aperture 1492A. Accordingly, in this arrangement, the fluid manifold 1442 and the one or more conduits 1494 do not extend into the internal cavity 1428.

[0366] In some examples, the distal manifold portion 2142B and the proximal manifold portion 2142A can be integrally formed a single, monolithic structure. In other examples, such as the example shown in Figures 21E-21H (and Figures 17D-17E described above), the distal manifold portion 2142B and the proximal manifold portion 2142A can be separate components that are coupled to each other. In this example, the distal manifold portion 2142B can include one or more channels 1742C (shown in Figure 17E) that extend between the first aperture 1492A and the second aperture 1492B, and the proximal manifold portion 2142 A can cover the one or more channels to define the one or more conduits 1494 (shown in Figure 21H). In other examples, the proximal manifold portion 2142A can include the one or more channels 1742C and the distal manifold portion 2142B can cover the one or more channels 1742C to define the one or more conduits 1494 (e.g., as shown in Figure 19).

[0367] As described above, in an example, the distal manifold portion 2142B, including the one or more channels 1742C, can be formed from a foam material (e.g., a closedcell foam such as, for instance, polyethylene (PE) foam and / or a cross-linked polyethylene (XLPE) foam). The foam material can help to balance comfort, conformability, and structural support resisting collapse. Also, in an example, the proximal manifold portion 2142A can be a membrane formed from a non-permeable material. The membrane of the proximal manifold portion 2142A can be bonded to the foam material of the distal manifold portion 2142B to couple the proximal manifold portion 2142A and the distal manifold portion 2142B to each other in one example.

[0368] As shown in Figure 21H and as described above and shown in Figures 17D-19 and 20C, the one or more conduits 1494 can include a first conduit on a first lateral side of thefluid inlet 1430 and a second conduit on a second lateral side of the fluid inlet 1430. This can provide improved suction performance as compared to alternative examples in which the fluid manifold 1442 includes a single conduit 1494. As shown in Figures 17D-19 and 20C, the channel(s) 1742C can include a single continuous channel that extends in a loop around the fluid inlet 1430.

[0369] As shown in Figure 21E, the second aperture 1492B can be in the distal manifold portion 2142B. As such, a center axis of the second aperture 1492B can be transverse (e.g., orthogonal) to the longitudinal axis 2160 (shown in Figure 21C) of the urine diversion device 2110. In this example, the fluid outlet 1436 can include the suction port 2138 to couple the second aperture 1492B of the fluid manifold 1442 to the whip tube 1540 (or the drain tube 112). As shown in Figures 21 A and 21E, the suction port 2138 can be configured to couple the whip tube 1540 to the second aperture 1492B at an acute angle with respect to the superior end of the urine diversion device 2110. This can allow the whip tube 1540 to be transverse to the longitudinal axis 2160 and extend in a superior direction, and / or improve fluid flow relative to implementations in which the suction port 2138 includes a 90 degree bend. In other examples, the whip tube 1540 can have a longitudinal axis that is parallel and / or collinear with the longitudinal axis 2160, and / or the suction port 2138 can include a 90 degree bend to couple the second aperture 1492B and the whip tube 1540. In other examples, the fluid outlet 1436 can omit the whip tube 1540 and the drain tube 112 can be coupled to the suction port 2138 instead of the whip tube 1540.

[0370] As shown in Figures 2 IE and 21G, the suction port 2138 can be coupled to a distal side of the liquid-impermeable backing 1424. The liquid-impermeable backing 1424 can include the aperture 1724 A to fluidly couple the fluid outlet 1436 (e.g., the suction port 2138) to the second aperture 1492B of the fluid manifold 1442. Accordingly, the suction port 2138, the aperture 1724 A in the liquid-impermeable backing 1424, and the second aperture 1492B of the fluid manifold 1442 can be aligned with each other to fluidly couple the fluid manifold 1442 and the fluid outlet 1436.

[0371] In some examples, the liquid-impermeable backing 1424 can be coupled to the fluid manifold 1442 only around the aperture 1724A and the second aperture 1492B (e.g., by a weld surrounding the aperture 1724A and the second aperture 1492B). This can allow for play between the fluid manifold 1442 and the liquid-impermeable backing 1424, which can help to improve conformability of the urine diversion device 2110 relative to alternative implementations (e.g., an implementation in which the fluid manifold 1442 is coupled to theliquid-impermeable backing 1424 over an entire length of the fluid manifold 1442). In other examples, the liquid-impermeable backing 1424 can be coupled to the fluid manifold 1442 around the aperture 1724 A and the second aperture 1492B, and at least another location. Coupling the liquid-impermeable backing 1424 to the fluid manifold 1442 around the aperture 1724 A and the second aperture 1492B can help to provide a liquid-tight seal, which can help to prevent leakage.

[0372] Figure 211 depicts a first perspective view of the suction port 2138, Figure 21 J depicts a second perspective view of the suction port 2138, and Figure 2 IK depicts a cross- sectional view of the suction port 2138 taken through the longitudinal axis 2160, according to an example. As shown in Figures 21I-21K, the suction port 2138 can include a fitting portion 2138A and a skirt portion 2138B that extends around a periphery of the fitting portion 2138A. The fitting portion 2138A can have a tube shape that is configured to couple to the whip tube 1540 or the drain tube 112. For instance, in Figures 21I-21K, the fitting portion 2138A can have an inner diameter that corresponds to an outer diameter of the whip tube 1540 or the drain tube 112. This can be beneficial in implementations in which the fitting portion 2138A is coupled to the whip tube 1540 (or the drain tube 112) by a press-fit coupling. In other examples, the fitting portion 2138A can be additionally or alternatively coupled to the whip tube 1540 or the drain tube 112 by a weld and / or an adhesive. In still other examples, instead of the fitting portion 2138A receiving the whip tube 1540 or the drain tube 112, the whip tube 1540 or the drain tube 112 can receive the fitting portion 2138A. For instance, the fitting portion 2138A can include a barbed feature and the whip tube 1540 or the drain tube 112 can be disposed over the barbed feature to couple the fitting portion 2138A and the whip tube 1540 or the drain tube 112.

[0373] As shown in Figure 2 IK, the fitting portion 2138A can include a first section 2138D having a first diameter, a second section 2138E having a second diameter, and a shoulder 2138F between the first section 2138D and the second section 2138E. The first diameter of the first section 2138D can be (i) greater than the second diameter of the second section 2138E, and (ii) greater than or equal to a diameter of the whip tube 1540 or the drain tube 112. The second diameter of the second section 2138E can be smaller than the diameter of the whip tube 1540 or the drain tube 112. In this arrangement, the first section 2138D can receive the whip tube 1540 or the drain tube 112, and the shoulder 2138F and the second section 2138E can provide s stop to limit an insertion depth of the whip tube 1540 or the drain tube 112 in the fitting portion 2138A. In some examples, the first section 2138D can have a lengththat is suitable to provide for a welded coupling between the fitting portion 2138A and the whip tube 1540 or the drain tube 112. Although a portion of the shoulder 2138F is proximal of the skirt portion 2138B in Figure 2 IK, the shoulder 2138F can be distal of the skirt portion 2138B such that the whip tube 1540 or the drain tube 112 do not extend proximally of the liquid- impermeable backing 1424 in other examples.

[0374] In Figures 21I-21K, the fitting portion 2138A extends through the skirt portion 2138B such that a section of the fitting portion 2138A extends through the aperture 1724 A of the liquid-impermeable backing 1424 to abut against the second aperture 1492B. However, in other examples, the fitting portion 2138A can be entirely distal of the liquid-impermeable backing 1424 (e.g., as shown in Figures 27A-27C).

[0375] The skirt portion 2138B is configured to be coupled to the liquid-impermeable backing 1424 and / or the fluid manifold 1442. For instance, as shown in Figures 211-21 J, the skirt portion 2138B, the liquid-impermeable backing 1424, the fluid manifold 1442 can be coupled to each other (e.g., via a weld) along a seam 2138C on the skirt portion 2138B. As shown in Figure 21J, the seam 2138C can extend around the fitting portion 2138A and, thus, around the aperture 1724A and the second aperture 1492B as well. This can help to provide a leak proof seal.

[0376] As shown in Figures 21I-21K, the fitting portion 2138A can have a center axis that is transverse to a plane of the skirt portion 2138B. As described above, this can allow the suction port 2138 to couple the whip tube 1540 (or the drain tube 112) to the second aperture 1492B at an acute angle with respect to the superior end of the urine diversion device 2110, which can allow the whip tube 1540 (or the drain tube 112) to be transverse to the longitudinal axis 2160 and extend in a superior direction, and / or improve fluid flow relative to implementations in which the suction port 2138 includes a 90 degree bend.

[0377] Additionally, as shown in Figure 2 IE and Figure 21H, the urine diversion device 2110 can also a shape retaining element 2101. In some examples, the shape retaining element 2101 can include a wire and / or a plate of a malleable material such as, for instance, a non-ferrous metal (e.g., aluminum and / or copper). In the example shown in Figure 21E and Figure 21H, the shape retaining element 2101 is an elongated plate of a malleable material. Additionally, as shown in Figure 2 IE, the shape retaining element 2101 can be coupled to the fluid manifold 1442 by an adhesive 2101A. Additionally, as shown in Figure 21H, the fluid manifold 1442 can include a recess 1742D that can receive the shape retaining element 2101.In Figure 21H, the distal manifold portion 2142B includes the recess 1742D on a proximal surface, and the proximal manifold portion 2142 A covers and encloses the shape retaining element 2101 in the recess 1742D when the proximal manifold portion 2142A is coupled to the distal manifold portion 2142B. In other implementations, the recess 1742D can on a distal side of the distal manifold portion 2142B instead of on a proximal side of the distal manifold portion 2142B (e.g., as shown in Figure 18A), or the shape retaining element 2101 can be entirely embedded within the distal manifold portion 2142B (e.g., as shown in Figure 18B).

[0378] Also, in Figure 21H, the recess 1742D and the shape retaining element 2101 can be surrounded by the channel(s) 1742C. However, the recess 1742D can be positioned differently relative to the channel(s) 1742C in other examples.

[0379] Figure 21G depicts an arrangement for coupling the liquid-impermeable backing 1424 to the user interface 1426. As shown in Figure 21G, the support layer 2126B of the user interface 1426 can include a recessed surface 2113 on a distal side of the support layer 2126B. For instance, the recessed surface 2113 can be defined by a lip 2215 that extends around a periphery of the distal side of the support layer 2126B, and extends distally from the recessed surface 2113. As shown in Figure 21G, the liquid-impermeable backing 1424 can be coupled to the recessed surface 2113 of the support layer 2126B. In this arrangement, the lip 2215 can help to shield from contact with the user both (i) an edge of the liquid-impermeable backing 1424 and (ii) the coupling between the support layer 2126B and the liquid- impermeable backing 1424. This can help to enhance user comfort.

[0380] As shown in Figure 21F, the urine diversion device 2110 can include a proximal side 2110A, a distal side 2110B, and one or more side walls 2110C that extend between the proximal side 2110A and the distal side 2110B. In this example, the user interface 1426 defines the proximal side 2110A, and the liquid-impermeable backing 1424 defines the distal side 2110B and the one or more side walls 2110C. The liquid-impermeable backing 1424 can define a receptacle that is enclosed on all sides, except the proximal side 2110A. Additionally, as shown in Figures 21F-21G, the liquid-impermeable backing 1424 can further include an upper peripheral edge 2125 that can define a flange that can extend outwardly in a plane away from the side wall(s) 2110C. The flange can help to increase a surface area for coupling the liquid-impermeable backing 1424 to the recessed surface 2113 of the support layer 2126B. Additionally, as shown in Figure 21G, the lip 2115 can extend distally of the flange at the upper peripheral edge 2125 such that the urine diversion device 2110 has no weld or seam along the proximal side 2110A of the user interface 1426 (which contacts the user). Asdescribed above, this can enhance user comfort.

[0381] In some examples, the user interface 1426 can be coupled to the liquid- impermeable backing 1424 by at least one coupling process selected from a group consisting of: lamination, radiofrequency (RF) seal, and impulse seal. When a foam of the user interface 1426 is coupled to the liquid-impermeable backing 1424 by a RF seal, a weld can go through the foam of the user interface 1426. This may leave a small impression, which can then be cut off. By contrast, when a foam of the user interface 1426 is coupled to the liquid-impermeable backing 1424 by an impulse seal, the weld may not go through the foam of the user interface 1426. It may be beneficial to use an impulse welding fixture for such implementations.

[0382] As shown in Figures 21E and 21G, the urine diversion device 2110 can also include a distal covering 2117 that extends over at least a portion of a distal side of the liquid- impermeable backing 1424. The distal covering 2117 can include one or more materials that can enhance user comfort. For instance, the distal covering 2117 can be formed from a soft fabric material such as, for instance, a Tricot knit open weave structure material.

[0383] As shown in Figure 21E, the distal covering 2117 can include an aperture 2117A that is aligned with the aperture 1724A in the liquid-impermeable backing 1424. This can allow the suction port 2138 to couple to the liquid-impermeable backing 1424 and extend through the distal covering 2117. In this example, the aperture 2117A of the distal covering 2217 can have a size that is greater than a size of the skirt portion 2138B of the suction port 2138 to facilitate coupling the suction port 2138 to the liquid-impermeable backing 1424 during assembly.

[0384] Also, in this example, the distal covering 2117 extends over substantially all of the liquid-impermeable backing 1424, except at the portion within the aperture 2117A of the distal covering 2117. This can help to reduce contact between the liquid-impermeable backing 1424 and the user. In other examples, the distal covering 2117 can extend over a different extent and / or a different portion of the liquid-impermeable backing 1424 such that one or more other portions of the liquid-impermeable backing 1424 are exposed and not covered by the distal covering 2117.

[0385] As shown in Figure 21G, the distal covering 2117 can be coupled to the upper peripheral edge 2125 of the liquid-impermeable backing 1424 such that the lip 2115 of the support layer 2126B extends distally of the coupling between the distal covering 2117 and the upper peripheral edge 2125 of the liquid-impermeable backing 1424. This can further help toenhance user comfort by recessing the coupling in manner that mitigates contact between the coupling and the user.

[0386] As shown in Figure 21G, the spacer 2198 can extend into the aperture of the support layer 2126B. For instance, during assembly, the spacer 2198 can be compressed and then allowed to expand up through the aperture of the support layer 2126B to abut against the proximal interface layer 2126A (not shown in Figure 21G). This can help to give the urine diversion device 2110 a plush feel when handled by the user. In one example, the spacer 2198 can have a thickness (e.g., in a dimension extending between the proximal side 2110A and the distal side 2110B, and perpendicular to the longitudinal axis 2160) of approximately 0.5 inches. This thickness has been found to provide sufficient volume to the internal cavity 2128 to receive and divert urine. However, the spacer 2198 can have a different thickness in other examples.

[0387] In an example, the proximal interface layer 2126 A can be a fabric material (e.g., a Tricot knit material such as, for instance, an approximately 1.0 ounce to approximately 1.2 ounce open weave Tricot knit), the support layer 2126B can be a closed-cell foam (e.g., a volara foam), the spacer 2198 can be an open-cell foam (e.g., a reticulated polyurethane foam including, for instance, approximately 15 to approximately 25 pores per inch), the fluid manifold 1442 can be a closed-cell foam (e.g., LD24 foam and / or a combination of a low- density polyethylene (LDPE) and ethylene vinyl acetate (EVA) copolymer), the liquid- impermeable backing 1424 can be an EVA film, the distal covering 2117 can be a fabric material (e.g., Tricot knit and / or non-woven fabric), the shape retaining element 2101 can be a metal (e.g., aluminum), and / or the whip tube 1540 can be a polyurethane tube. In some examples, the fluid manifold 1442 can be formed by compression molding to form the channels 1742C, and / or the liquid-impermeable backing 1424 can be formed by a vacuum forming process.

[0388] In some examples, as shown in Figures 21A and 21E, the urine diversion device 2100 can include a visual indicator 2119 that can be positioned on the distal side 2110B to provide a guide for placement of the urine diversion device 2110 on the user. For example, in Figure 2 IE, the visual indicator 2119 can include a line that corresponds to a shape of the fluid inlet 1430 to help visualize the location of the fluid inlet 1430 when positioning the proximal side 2110A of the urine diversion device 2110 on the user.

[0389] Figures 22A-22E depict the urine diversion device 2110 with a visual indicator2219A-2219E on the liquid-impermeable backing 1424 according to additional examples. In each of these examples, the visual indicator 2219A-2219E can provide visual indications that can help to position the urine diversion device 2110 such that the fluid inlet 1430 is adjacent to a urethral opening of the user when the urine diversion device 2110 is positioned on the user. In Figure 22A, the visual indicator 2219A includes (i) a superior arc and an inferior arc that indicate a central region of the fluid inlet 1430 and (ii) a vertical line between the pair of curved arcs that indicates the longitudinal axis 2160 at a center of the urine diversion device 2110. In Figure 22B, the visual indicator 2219B includes a vertical line that indicates the longitudinal axis 2160 at the center of the urine diversion device 2210. In Figure 22C, the visual indicator 2219C includes a crosshair symbol to indicate a target position for alignment with the user. In Figure 22D, the visual indicator 2219D includes (i) the vertical line of Figure 22B and (ii) additional vertical lines laterally disposed from the center and of decreasing lengths along a direction from the center towards the side walls (e.g., the side walls 2110C in Figure 2 IF). In Figure 22E, the visual indicator 2219E includes an elongated loop that indicates a target position for alignment with the user.

[0390] Figure 23A depicts the urine diversion device 2110 with a visual indicator 2321A on the user interface 1426, according to an example. In this example, the visual indicator 2321 can include a printed graphic that indicates a position of the fluid inlet 1430 under the proximal interface layer 2126A (e.g., an area that has a color that is different from a color of a remainder of the proximal interface layer 2126A). This can be beneficial in implementations in which the fluid inlet 1430 is not clearly visible under the proximal interface layer 2126A. The visual indicator 2321 on the proximal interface layer 2126A can additionally or alternatively provide a visual indication that can help to position the urine diversion device 2110 such that the fluid inlet 1430 is adjacent to a urethral opening of the user when the urine diversion device 2110 is positioned on the user

[0391] Figure 23B depicts an implementation of the urine diversion device 2110 in which the proximal interface layer 2126 A includes a plurality of perforations, according to an example. The perforations can assist in transferring urine through the proximal interface layer 2126A to the fluid inlet 1430. Figure 23C-23D depict an implementation of the urine diversion device 2110 in which the proximal interface layer 2126A includes a plurality of perforations and the visual indicator 2321, according to some examples.

[0392] In some examples, the suction port 2138 can include an orientation indicator 2123 that is configured to provide an indication as to the superior end and the inferior end ofthe urine diversion device 2110. As one example, Figure 24A depicts an implementation of the urine diversion device 2110 that includes a caret pointing towards the superior end as the orientation indicator 2123. As another example, Figure 24B depicts an implementation of the urine diversion device 2110 that includes a picture of a person with a head nearer the superior end and legs nearer the inferior end as the orientation indicator 2123. As still another example, Figure 24C depicts an implementation of the urine diversion device 2110 that includes an arrow pointing towards the superior end as the orientation indicator 2123.

[0393] In use, the urine diversion device 2110 is positioned on the user with the fluid inlet 1430 adjacent to a urethral opening of the user. After the urine diversion device 2110 is positioned on the user, the urine diversion device 2110 can receive the fluid (e.g., urine) from the user through the fluid inlet 1430 and into the internal cavity 1428. The fluid can move in an inferior direction from the fluid inlet 1430 toward the first aperture 1492 A of the fluid manifold 1442. When a vacuum pressure is applied to the fluid outlet 1436 (e.g., by the vacuum device 116 via the air tube 122 and the drain tube 112), the vacuum pressure can propagate through the conduits 1494 of the fluid manifold 1442 to the first aperture 1492 A. With the assistance of the vacuum pressure, the fluid can be egressed from the internal cavity 1428 through the first aperture 1492 A, along the conduits 1494, through the second aperture 1492B, and out the fluid outlet 1436 to the drain tube 112 and the waste collection receptacle 114. Within examples, the vacuum pressure applied to the fluid manifold 1442 can direct the fluid along this this flow pathway and against the force of gravity.

[0394] Figures 21 A-24C depict some additional example implementations of the urine diversion device 1610 shown in Figure 16. In other examples, one or more components of the urine diversion device 2110 shown in Figures 21A-24C can be omitted, two or more of the components of the urine diversion device 2110 shown in Figures 21A-24C can be combined, and / or the urine diversion device 2110 can have one or more of the features described above with respect to any other urine diversion device disclosed herein. For instance, in another implementation, one or more of the wi eking material 1570, the hydrophobic top sheet 1599, and / or the gasket 1596 can be included. Also, in other examples, the urine diversion device 2110 can further include an attachment member (e.g., the attachment member 1248 shown in Figures 12A-13B).

[0395] In the example shown in Figures 21A-21H, the channel(s) 1742C are on the proximal side of the distal manifold portion 2142B. However, as described above, in some examples, the fluid manifold 1442 can include the channel(s) 1742C on a distal side of the fluidmanifold 1442, and the first aperture 1492 A can extend through the fluid manifold 1442 from the distal side to a proximal side of the fluid manifold 1442. Figures 25A-25B depict an implementation of the urine diversion device 2110, according to one implementation of such examples. Figure 25A depicts the distal side of the fluid manifold 1442 and Figure 25B depicts the proximal side of the fluid manifold 1442, according to the example.

[0396] As shown in Figure 25A, the fluid manifold 1442 includes the channel(s) 1742C on a distal side of the fluid manifold 1442, and the first aperture 1492A extends through the fluid manifold 1442 from the distal side to a proximal side of the fluid manifold 1442 at an interior end of the channel(s) 1742C. When assembled, the liquid-impermeable backing 1424 covers the channel(s) 1742C to define the conduit(s) 1494 (not shown in Figure 25A).

[0397] As shown in Figures 25A-25B, the fluid manifold 1442 also includes one or more third apertures 2592 located at a superior end of the channel(s) 1742C and extending through the distal manifold portion 2142B. As shown in Figure 25B, the distal manifold portion 2142B can include a recessed chamber 2527 that can communicate with the third aperture(s) 2592 and the second aperture 1492B. In this arrangement, fluid (e.g., urine) received in the internal cavity 1428 can pass through the first aperture 1492 A from the proximal side of the fluid manifold 1442 to the distal side of the fluid manifold 1442 and into the channel(s) 1742C. With the assistance of a vacuum pressure, the fluid can be egressed from the internal cavity 1428 through the first aperture 1492 A, along the channel(s) 1742C (and conduit(s) 1494 defined by the channel(s) 1742C and the liquid-impermeable backing 1424), through the third apertures 2592 into the recessed chamber 2527, from the recessed chamber 2527 through the second aperture 1492B, and out the fluid outlet 1436 to the drain tube 112 and the waste collection receptacle 114.

[0398] In the example shown in Figures 21A-21H, the proximal manifold portion 2142A extends over the recess 1742D on the proximal surface of the distal manifold portion 2142B. However, in another example shown in Figure 26, the proximal manifold portion 2142A can include a cutout 2627 at the recess 1742D of the distal manifold portion 2142B and the shape retaining element 2101 (e.g., the shape retaining element 2101 is not enclosed by the proximal manifold portion 2142A). This can help to mitigate the shape retaining element 2101 pulling the proximal manifold portion 2142A away from the distal manifold portion 2142B at the channel(s) 1742C.

[0399] Referring now to Figures 27A-27C, another implementation of the suction port2138 for the urine diversion device 2110 is shown according to another example. In particular, Figure 27A shows a first perspective view of a suction port 2738, Figure 27B depicts a second perspective view of the suction port 2738, and Figure 27C depicts a cross-sectional view of the suction port 2738 taken through the longitudinal axis 2160, according to an example. The suction port 2738 is substantially similar to the suction port 2138, except the fitting portion 2138A does not extend distally of the skirt portion 2138B. As such, the fitting portion 2138A and the whip tube 1540 and / or the drain tube 112 (shown in Figure 2 IE) can be entirely distal of the liquid-impermeable backing 1424.

[0400] In Figures 21F-21G, the coupling between the liquid-impermeable backing 1424 and the user interface 1426 is recessed within the lip 2115 and the recessed surface 2113 of the support layer 2126B. As described above, this can result in no weld or seam along the proximal side 2110A of the user interface 1426 (which contacts the user), and enhance user comfort. In another example, the user interface 1426 can be coupled to the liquid-impermeable backing on the distal side 2110B of the urine diversion device 2110. As examples, Figure 28 A depicts an implementation in which the user interface 1426 is coupled to the liquid- impermeable backing 1424 by a weld 2829A along the distal side 2110B of the urine diversion device 2110, and Figure 2B depicts an implementation in which the user interface 1426 is coupled to the liquid-impermeable backing 1424 by a stitch joint 2829B on the distal side 2110B of the urine diversion device 2110.

[0401] In the example shown in Figures 21F-21G, the spacer 2198 can be substantially flush with proximal interface layer 2126A at the proximal side 2110A. However, in other examples, the user interface 1426 and / or the spacer 2198 can be configured to provide a concavity at the proximal side 2110A of the urine diversion device 2110. This may be beneficial in implementations in which the urine diversion device 2110 is used by a user with a micro-penis or a retracted penis. Figures 29A-29B depict examples in which the user interface 2426 includes a concavity at the proximal side 2110A of the urine diversion device 2100, according to some examples. In Figure 29A, the spacer 2198 is offset distally from the user interface 1426 such that a gap is defined between the spacer 2198 and the proximal side 2110A of the urine diversion device 2110. The gap can help to assist with receiving fluid into the internal cavity 1428 and / or providing space to accommodate a penis when the urine diversion device 2110 is positioned against the body of a user. In Figure 29B, the spacer 2198 has a concavity 2931 to accommodate a penis when the urine diversion device 2110 is positioned against the body of a user. Additionally, in Figure 29B, the user interface 1426includes a gasket 1526 to assist in directing urine through the fluid inlet 1430 and help to reduce or mitigate leakage.

[0402] Figure 30 depicts another implementation of the liquid-impermeable backing 1424 for the urine diversion device 2110, according to another example. In Figure 30, the liquid-impermeable backing 1424 includes a plurality of ribs 3033 that extend laterally between the lateral wall(s) 2010C of the urine diversion device 2110. The ribs 3033 can help to enhance a rigidity of the urine diversion device 2110 laterally and / or longitudinally (e.g., along the longitudinal axis 2060 shown in Figure 21C). The ribs 3033 can additionally or alternatively help to inhibit flaring during flexion of the urine diversion device 2010.

[0403] Within examples, it can be beneficial to reduce a risk of the channel(s) 1542D, 1742C deforming when stress is applied to the urine diversion device 1410, 1510, 1610, 1710, 2010, 2110 by the body of the user (e.g., the thighs of the user). In some examples, the urine diversion device 1410, 1510, 1610, 1710, 2010, 2110 can include one or more features that are configured to enhance an integrity of the channel(s) 1542D, 1724C. For instance, in some implementations, a component that covers the channel(s) 1542D, 1742C (e.g., the proximal manifold portion 2142A) can have a suitable thickness to resist buckling of the channel(s) 1542D, 1742C. In one implementation, the proximal manifold portion 2142A of the urine diversion device 2110 can have a thickness that is greater than or equal to approximately 30 millimeters to resist buckling of the channel(s) 1742C.

[0404] Figures 31A-37D depict additional or alternative features for resisting (or preventing) buckling of the channel(s) 1542D, 1742C. Although these features are described below with respect to the urine diversion device 2100 shown in Figures 21A-21H described above, the features can be implemented in any of the urine diversion devices described herein. Indeed, any feature described with respect to any example urine diversion device described herein can be implemented in any of the other example urine diversion device described herein unless explicitly stated otherwise.

[0405] As another example, Figures 31A-31C depict an implementation of the urine diversion device 2110 that includes one or more reinforcing members 3133 positioned in the channel(s) 1742C of the fluid manifold 1442 to resisting buckling of the channel(s) 1742C when stress is applied to the urine diversion device 2110. Figure 31 A depicts a proximal side view of the urine diversion device 2110, Figure 3 IB depicts a proximal side view of the urine diversion device 2110 of Figure 31 A with the user interface 1426 and the spacer 2198 omitted,Figure 31C depicts a cross-sectional view of the urine diversion device 2110 shown in Figure 31 A, and Figure 3 ID depicts a perspective view of the reinforcing member 3133, according to an example.

[0406] As shown in Figures 31C-31D, each reinforcing member 3133 can be an elongated structure having two parallel walls and a transverse wall extending between the two parallel walls (e.g., having a U-shaped cross-section). In one example, the reinforcing member(s) 3133 can be formed from a material that is suitably rigid to mitigate (or prevent) deflection responsive to lateral stress, but has sufficient flexibility to allow for the shape retaining element 2101 to provide malleability to the urine diversion device 2110. As an example, the reinforcing member(s) 3133 can be formed from a polymer material.

[0407] As shown in Figure 3 IB, each reinforcing member 3133 can extend along a first portion of the channel(s) 1742C, and not along a second portion of the channel(s) 1742C. For instance, the reinforcing member(s) 3133 can extend along portions of the urine diversion device 2110 that are expected to undergo the greatest stress when the urine diversion device 2110 is positioned on the user (e.g., between the thighs of the user). As shown in Figure 3 IB, the reinforcing member(s) 3133 can be at an intermediate portion between a superior end and an inferior end of the channel(s) 1742C, and not at a distal portion and a proximal portion of the channel(s) 1742C. In other examples, the reinforcing member(s) 3133 can additionally or alternatively extend along an entirety of the channel(s) 1742C, the distal portion of the channel(s) 1742C, and / or the proximal portion of the channel(s) 1742C.

[0408] Figures 32A-32 depict another implementation of the urine diversion device 2110 that includes one or more reinforcing members positioned over the channel(s) 1742C of the fluid manifold 1442 to resisting buckling of the channel(s) 1742C when stress is applied to the urine diversion device 2110. Figure 32A depicts a proximal side view of the fluid manifold 1442, and Figure 32B depicts a cross-sectional view of the urine diversion device 2110 at the channel 1742C shown in Figure 32A, according to an example. In this example, the shape retaining element 2101 provides a reinforcing member over the channel 1742C. As shown in Figure 32B, the shape retaining element 2101 can also extend over the proximal manifold portion 2142A in this example. In Figure 32B, the shape retaining element 2101 is also coupled to the proximal manifold portion 2142 by a film 3235.

[0409] Although the shape retaining element 2101 provides the reinforcing member in Figures 32A-32B, the shape retaining element 2101 can instead be in a different positionand a non-malleable reinforcing member can be positioned over the channel(s) 1742C in Figures 32A-32B in other examples.

[0410] As another example, the urine diversion device 2110 can additionally or alternatively be configured to resist buckling at the channel(s) 1742C by one or more stressrelief sections. For instance, the fluid manifold 1442 can have lateral sides 3342A that are thinner (in a dimension extending between the proximal manifold portion 2142A and the distal manifold portion 2142B) than a center portion 3342B of the fluid manifold 1442. Figure 33A depicts a proximal side view of the distal manifold portion 2142B including stress-relief sections at the lateral sides 3342A, Figure 33B depicts a side view of the distal manifold portion 2142B shown in Figure 33A, and Figure 33C depicts a proximal side view of the proximal manifold portion 2142A, according to an example. As shown in Figures 33A-33B, the distal manifold portion 2142B includes less material and, therefore, is thinner at the lateral sides 3342A. In some implementations, the thinner lateral sides 3342A of the distal manifold portion 2142B can be formed by a process of removing material from the distal manifold portion 2142B. In other implementations, the thinner lateral sides 3342A can be formed without removing material. Additionally or alternatively, as shown in Figure 33C, the proximal manifold portion 2142A has a width that is smaller than a maximum width of the distal manifold portion 2142B. For instance, the proximal manifold portion 2142A can have a shape that corresponds to a shape of the center portion 3342B. Providing the stress-relief sections at the lateral sides 3342A can help to inhibit (or prevent) transferring stress and / or strain from the lateral sides 3342A to the channels 1742C.

[0411] In another implementation, the fluid manifold 1442 can include a stress-relief section at the center portion 3342B. For instance, in Figures 34A-34B, the shape retaining element 2101 is located on the distal side of the distal manifold portion 2142B (shown in Figure 34A) and the proximal side of the distal manifold portion 2142B includes a recess 3437 (shown in Figure 34B) that provides the stress-relief section. In this arrangement, when stress or strain is applied to the lateral sides of the fluid manifold 1442, the fluid manifold 1442 can preferentially deflect at the recess 3437 instead of the channels 1724C.

[0412] As another example, the urine diversion device 2110 can additionally or alternatively be configured to resist buckling at the channel(s) 1742C by providing a single channel 1742C at the center portion 3342B of the fluid manifold as shown in Figure 35.

[0413] Referring to Figures 36A-36B, another implementation of the urine diversiondevice 2110 is shown according to another example. Figure 36A depicts the proximal side 2110A of the implementation of the urine diversion device 2110 and Figure 36B depicts the distal side 2110B of the implementation of the urine diversion device 2110, according to the example. The urine diversion device 2110 shown in Figures 36A-36B substantially similar to the urine diversion device 2110 shown in Figures 21 A-21H, except the proximal interface layer 2126A and the distal covering 2117 extend outwardly from the other components of the urine diversion device 2110 to form a flap portion 3639. The flap portion 3639 can help to improve user comfort.

[0414] In additional or alternative implementations, the urine diversion device 2110 can include an outer cover 3741 that can extend around the urine diversion device 2110. As an example, Figure 37A depicts the outer cover 3741, Figure 37B depicts a first step for coupling the outer cover 3741 to the urine diversion device 2110 shown in Figures 21 A-21H, Figure 37C depicts a second step for coupling the outer cover 3741 to the urine diversion device 2110 shown in Figures 21A-21H, and Figure 37D depicts a third step for coupling the outer cover 3741 to the urine diversion device 2110 shown in Figures 21A-21H, according to an example. Within examples, the outer cover 3741 can be formed from a fabric material (e.g., a Tricot knit material). This can help to improve user comfort.

[0415] As shown in Figure 37 A, the outer cover 3741 includes a superior portion 3741A and an inferior portion 3741B. The superior portion 3741A is movable relative to the inferior portion 3741B to provide access to an interior compartment 3743 of the outer cover 3741. As shown in Figure 37B, the superior portion 3741 A can be folded away from the inferior portion 3741B to expose the interior compartment 3743. As shown in Figure 37C, the urine diversion device 2110 can then be inserted into the inferior portion 3741B. As shown in Figure 37D, the superior portion 3741 A can then be folded back over the urine diversion device 2110 to enclose the urine diversion device 2110 in the interior compartment 3743 of the outer cover 3741. As shown in Figure 37A, the outer cover 3741 can include a slot 3741C to receive the suction port 2138 in some examples.

[0416] As described above, the drain tube 112 can couple the urine diversion device 110 (e.g., the urine diversion devices 210, 310, 410, 510, 610, 710, 810, 910, 1010, 1110, 1310, 1410, 1510, 1610, 1710, 2010, 2110) to the waste collection receptacle 114. Additionally, as described above, in some examples, the urine diversion device 110 can include the attachment member 1248 that can help to couple the urine diversion device 110 to the user and / or help to maintain a portion of the drain tube 112 in a fixed position relative to the user.

[0417] Figures 38A-40 depict additional or alternative implementations of the attachment member 1248 shown and described above with respect to Figures 12A-13B.

[0418] Figure 38A depicts a first view of an attachment member 3848 in a first state, Figure 38B depicts a second view of the attachment member 3848 in the first state on the whip tube 1540, Figure 38C depicts the attachment member 3848 in the first state on the whip tube 1540, and Figure 38D depicts the attachment member 3848 in a second state on the whip tube 1540, according to an example. Although Figures 38B-38D depict the attachment member 3848 in the first state and the second state on the whip tube 1540, the attachment member 3848 can alternatively be coupled to the drain tube 112 in a similar manner according to further examples.

[0419] The attachment member 3848 is substantially similar or identical to the attachment member 1248 described above with respect to Figures 12A-13B, except the attachment member 3848 includes an axial retention mechanism 3845 that is configured to: (i) allow the attachment member 3848 to move relative to the whip tube 1540 when the attachment member 3848 is in the first state, and (ii) axial retain the whip tube 1540 in a fixed position relative to the attachment member 3848 when the attachment member 3848 is in the second state.

[0420] Accordingly, as shown in Figure 38 A, the attachment member 3848 includes a first lateral portion 1248 A, a second lateral portion 1248B, an intermediate portion 1248C between the first lateral portion 1248A and the second lateral portion 1248B, and a bridge portion 1248D that extends from the first lateral portion 1248 A to the second lateral portion 1248B and over the intermediate portion 1248C. In this arrangement, the intermediate portion 1248C and the bridge portion 1248D define a channel 1248E that is configured to receive the whip tube 1540. In this example, the attachment member 3848 includes an adhesive on an inner surface of the channel 1248E. The axial retention mechanism 3845 includes a release liner 3845 A that extends through a lateral opening 3845B in the channel 1248E. As shown in Figure 38B, a portion of the release liner 3845A is between the adhesive in the channel 1248E and the whip tube 1540, and prevents the adhesive from engaging the whip tube 1540 in the first state. While the adhesive in the channel 1248E does not engage the whip tube 1540 (in the first state), the attachment member 3848 can move relative to the whip tube 1540.

[0421] To actuate the attachment member 3848 from the first state shown in Figure 38C to the second state shown in Figure 38D, the release liner 3845 A can be removed from theadhesive in the channel 1248E and the channel 1248E can be pressed against the whip tube 1540 to fixedly couple the attachment member 3848 to the whip tube 1540. In this example, the release liner 3845 A can be removed from the adhesive by pulling on a portion of the release liner 3845A that is external to the channel 1248E (e.g., due to the release liner 3845A extending through the lateral opening 3845B) in a lateral direction that is transverse to a center axis of the channel 1248E. As shown in Figures 38A and 38C, the release liner 3845A can include a visual indicator 3845C that provides a visual indication of the lateral direction for pulling the portion of the release liner 3845 A. This can help an operator to more readily understand the operations for coupling the attachment member 3848 to the whip tube 1540.

[0422] Figures 39A-39C depict an attachment member 3948 that includes another implementation of the axial retention mechanism 3845, according to another example. The attachment member 3948 is substantially similar to the attachment member 1248, 3948 describe above, except the axial retention mechanism 3845 includes an adhesive strip 3947 (e.g., tape) that is coupled to the whip tube 1540 adjacent to the channel 1248E. In Figure 39A, the adhesive strip 3947 includes a release liner 3947A that prevents the adhesive strip 3947 from coupling to the whip tube 1540. This allows the attachment member 3948 to move relative to the whip tube 1540. In Figure 39B, the release liner is removed from the adhesive strip 3947. In Figure 39C, the adhesive strip is couples the attachment member 3948 to the whip tube 1540.

[0423] In Figures 39A-39C, the attachment member 3948 includes two channels 1248E separated by a gap, and the adhesive strip 3947 extends along the gap. However, in other examples, the attachment member 3948 can include one channel 1248E.

[0424] As yet another example, Figures 40A-40E depicts a plurality of clips 4051 that can be coupled to the attachment member 1248 in addition or alternative to the channel 1248E and / or the axial retention mechanisms described herein. The clips 4051 can be configured to removably couple the attachment member 1248 to the whip tube 1540. Within examples, the attachment member 1248 can thus include one or more of the clips 4051 shown in Figures 40A- 40E.

[0425] Figures 41A-41C depict a urine diversion device 4110 as another implementation of the urine diversion device 1410, 1610, 2010, 2110 shown and described above with respect to Figures 14-40, according to another example. Figure 41A shows a proximal side view of the urine diversion device 4110, Figure 4 IB shows a distal side view ofthe urine diversion device 4110, and Figure 41C shows an exploded view of the urine diversion device 4110, according to an example.

[0426] The urine diversion device 4110 can be substantially similar or identical to the urine diversion device 2110 described above, except the proximal interface layer 2126A is distal of the support layer 2126B in Figures 41 A-41C. In this arrangement, the user discharges the urine, the urine is first received through the fluid inlet 1430 before contacting the proximal interface layer 2126A. By contrast, in Figures 21A-21K, the urine first contacts the proximal interface layer 2126A before passing through the fluid inlet 1430. In some instances, a small portion of the urine that contacts the proximal interface layer 2126 A may not be received through the fluid inlet 1430 because the small portion of urine may spread along the proximal interface layer 2126 A away from the fluid inlet 1430 due to capillary action, surface tension, and / or wetting dynamics. By positioning the proximal interface layer 2126A distal of the support layer 2126B, a greater extent of the urine can be received in the internal cavity 1428 and the support layer 2126B can provide a physical barrier to help inhibit the spread of the urine.

[0427] Additionally, as shown in Figures 41B-41C, the urine diversion device 4110 can include one or more vent apertures 4149 in the liquid-impermeable backing 1424. The vent apertures 4149 can help to limit a pressure applied within the internal cavity 1428 by the vacuum device. In some implementations, the vent aperture(s) 4149 can be positioned nearer to a superior end of the urine diversion device 4110 than an inferior end of the urine diversion device 4110 (e.g., at or above a superior end of the fluid inlet 1430). This can help to reduce a risk of leakage of urine out the vent aperture(s) 4149 as the urine is unlikely to migrate to the vent aperture(s) 4149 when the urine diversion device 4110 is coupled to the user (e.g., with the superior end above the inferior end).

[0428] Figures 42A-42C depict a spacer 4298 as an implementation of the spacer 1598, 2198 that can be used with the urine diversion devices 1410, 1610, 2010, 2110, 4110 described above, according to another example. The spacer 4298 includes a proximal spacer portion 4253A and a distal spacer portion 4253B. When assembled in the urine diversion device 1410, 1610, 2010, 2110, 4110, the proximal spacer portion 4253A can face a proximal direction (e.g., toward the user when the user interface 1426 is positioned on the user) and the distal spacer portion 4253B can face a distal direction (e.g., away from the user when the user interface 1426 is positioned on the user).

[0429] Within examples, the proximal spacer portion 4253A is a first foam having a first pore size, the distal spacer portion 4253B is a second foam having a second pore size, and the first pore size is smaller than the second pore size. In this arrangement, the relatively smaller pore size of the proximal spacer portion 4253 A can provide enhanced patient comfort, whereas the relatively larger pore size of the distal spacer portion 4253B can provide enhanced fluid transport.

[0430] In some examples, the proximal spacer portion 4253A and the distal spacer portion 4253B can be coupled to each other at an interface 4353C between the proximal spacer portion 4253A and the distal spacer portion 4253B. For instance, the proximal spacer portion 4253 A can be coupled to the distal spacer portion 4253B by at least one coupling selected from a group consisting of (i) an adhesive, (ii) a mechanical coupling (e.g., stitches and / or a frame), and (iii) interlocking features (e.g., dovetail structures and / or tongue-and-groove joints).

[0431] Figures 42A-42C show dimensions for a height H, a width W, and a thickness T of the spacer 4298. In the example shown in Figures 42A-42C, the height H and the width W of proximal spacer portion 4253A are approximately equal to the height H and the width W of the distal spacer portion 4253B. As shown in Figures 42A and 42C, the thickness T of the proximal spacer portion 4253A can be less than the thickness T of the distal spacer portion 4253B. Liquid moves through the proximal spacer portion 4253 A slower than the distal spacer portion 4253B due to the relatively smaller pore sizes of the proximal spacer portion 4253A. As such, it can be beneficial for the proximal spacer portion 4253A to be provided as a relatively thin layer, whereas the distal spacer portion 4253B provides a majority of the volume of the spacer 4298 to provide superior liquid transport and / or resistance to compression.

[0432] In other examples, the height H and / or the width W of the proximal spacer portion 4253 A and the distal spacer portion 4253B can also be different. As one other example, Figures 43A-43C depict a spacer 4398 as another implementation of the spacer 1598, 2198, 4298 that can be used with the urine diversion devices 1410, 1610, 2010, 2110, 4110 described above. The spacer 4398 can be substantially similar or identical to the spacer 4298 described above, except the height H and the width W of the proximal spacer portion 4253 A are smaller than the height H and the width W of the distal spacer portion 4253B. In this arrangement, the proximal spacer portion 4253A can positioned in the fluid inlet 1430 while the distal spacer portion 4253B abuts against the user interface 1426 to assist in retaining the spacer 4353 in the internal cavity 1428.

[0433] Although an outer profile (e.g., defined by the height H and the width W) of the proximal spacer portion 4253 A and the distal spacer portion 4253B is a rectangular shape in Figures 42A-42C, the height H, the outer profile of the proximal spacer portion 4253 A and / or the distal spacer portion 4253B can have any of the shapes shown for the spacers 1598, 2198 and / or the fluid inlets 1430 in Figures 15A-37D.

[0434] In some of the examples described above, the fluid manifold 1442 includes the proximal manifold portion 1542C, 1742A, 2142A coupled to the distal manifold portion 1542B, 1742B, 2142B. As described above, one of the proximal manifold portion 1542C, 1742A, 2142A and the distal manifold portion 1542B, 1742B, 2142B includes one or more channels 1542D, 1742C, and the other of the proximal manifold portion 1542C, 1742A, 2142A and the distal manifold portion 1542B, 1742B, 2142B can cover the channel(s) 1542D, 1742C to define the one or more conduits 1494. This two-part construction can allow for flexible manufacturing by various production processes (including, e.g., a thermoforming process for forming the one or more channels 1542D, 1742C).

[0435] In other examples, the fluid manifold can be integrally formed as a single, monolithic structure. As one example, Figures 44A-44F depict a urine diversion device 4410 including a fluid manifold that is formed as a single, monolithic structure. Figure 44A depicts a first perspective view of the urine diversion device 4410, Figure 44B depicts a second perspective view of the urine diversion device 4410, Figure 44C depicts a partially exploded view of the urine diversion device 4410, Figure 44D depicts a perspective view of the urine diversion device 4410 with the proximal interface layer 2126 A omitted, Figure 44E depicts a view of a proximal side of the urine diversion device 4410 with the proximal interface layer 2126 A omitted, and Figure 44F depicts a fluid manifold 4442 of the urine diversion device 4410, according to the example.

[0436] As shown in Figures 44A-44C, the urine diversion device 4410 can include the user interface 1426 coupled to the liquid-impermeable backing 1424, and the user interface 1426 can include the proximal interface layer 2126A. As shown in Figure 44C, the fluid manifold 442 is distal of the user interface 1426 and configured to receive urine that passes through the user interface 1426. As shown in Figures 44A-44F, the fluid manifold 442 includes the first aperture 1492 A in fluid communication with the internal cavity 1428, the second aperture 1492B that is coupled to the fluid outlet 1436, and the one or more conduits 1494 that extend from the first aperture 1492A to the second aperture 1492B. In this example, the first aperture 1492 A, the second aperture 1492B, and the one or more conduits 1494 are formed bya single piece of material as a single, monolithic structure. For instance, the fluid manifold 1442 can be formed by injection molding. In this arrangement, responsive to a vacuum pressure applied to the fluid outlet 1436, the fluid manifold 1442 is configured to evacuate the fluid from the internal cavity 1428, through the first aperture 1492 A, along the one or more conduits 1494, and through second aperture 1492B to the fluid outlet 1436. The fluid can then be diverted from the fluid outlet 1436 along a drain tube to a waste collection receptacle, as described above (e.g., along the drain tube 112 to the waste collection receptacle 114 shown in Figure 1.

[0437] As described above, the fluid manifold 1442 can include one or more conduits 1494. In some of the examples described above, the fluid manifold 1442 is shown with the one or conduits 1494 in an arrangement in which the one or more conduits 1494 include a first conduit on a first lateral side of the fluid inlet 1430 and a second conduit on a second lateral side of the fluid inlet 1430. In other examples, the one or more conduits 1494 can have other arrangements.

[0438] Figures 45-51 depict alternative arrangements for the one or more conduits 1494 according to further examples. In Figures 45A-51, the fluid manifold 1442 includes a superior end 4563, an inferior end 4565 opposite the superior end 4563, a first lateral side 4567, and a second lateral side 4569 opposite the first lateral side 4567.

[0439] Figure 45 depicts an implementation of the fluid manifold 1442 including a plurality of conduits 4594A-4594C arranged in an arrow shape pointing toward the superior end 4563, according to an example. In this example, the fluid manifold 1442 includes a proximal manifold portion 4542A and a distal manifold portion 4542B that are configured to be coupled to each other to define the conduits 4594A-4594C. In other examples, the proximal manifold portion 4542A and the distal manifold portion 4542B can be integrally formed as a single, monolithic structure.

[0440] As shown in Figure 45, the conduits 4594A-4594C include a superior point 4594D, a first conduit 4594A extending in an inferior direction from the superior point 4594D toward the inferior end 4565, a second conduit 4594B extending from the superior point 4594D in a first transverse direction toward the inferior end 1465 and the first lateral side 4567, and a third conduit 4594C extending from the superior point 4594D in a second transverse direction toward the inferior end 4565 and the second lateral side 4569. The proximal manifold portion 4542A includes the first aperture 1492A at respective inferior ends of the first conduit 4594A,the second conduit 4594B, and the third conduit 4594C. The distal manifold portion 4542B includes the second aperture 1492B at the superior point 4594D.

[0441] In some examples, the first aperture 1492 A at the inferior end of the first conduit 4594A can be larger than the first aperture 1492A at the inferior end of the second conduit 4594B and / or the first aperture 1492A at the end of the third conduit 4594C. This can help to provide greater suction at the first aperture 1492A at the end of the first conduit 4594A where gravity may move urine that is not captured at the first aperture 1492A of the inferior ends of the second conduit 4594B and / or the third conduit 4594C.

[0442] Figure 46 depicts an implementation of the fluid manifold 1442 including a plurality of conduits 4694A-4694C arranged in an arrow shape pointing toward the inferior end 4565, according to an example. In this example, the fluid manifold 1442 includes a proximal manifold portion 4642A and a distal manifold portion 4642B that are configured to be coupled to each other to define the conduits 4694A-4694C. In other examples, the proximal manifold portion 4642A and the distal manifold portion 4642B can be integrally formed as a single, monolithic structure.

[0443] As shown in Figure 46, the conduits 4694A-4694C include an inferior point 4694D, a first conduit 4694A extending in a superior direction from the inferior point 4694D toward the superior end 4563, a second conduit 4694B extending from the inferior point 4694D in a first transverse direction toward the superior end 4563 and the first lateral side 4567, and a third conduit 4694C extending from the inferior point 4694D in a second transverse direction toward the superior end 4563 and the second lateral side 4569. The proximal manifold portion 4642 A includes the first aperture 1492 A at the inferior end of the first conduit 4694 A and at respective superior ends of the second conduit 4694B and the third conduit 4694C. The distal manifold portion 4642B includes the second aperture 1492B at a superior end of the first conduit 4694A.

[0444] In some examples, the first aperture 1492 A at the inferior end of the first conduit 4694 A can be larger than the first aperture 1492 A at the superior end of the second conduit 4694B and / or the first aperture 1492A at the superior end of the third conduit 4694C. This can help to provide greater suction at the first aperture 1492A at the end of the first conduit 4694 A where gravity may move urine that is not captured at the first aperture 1492 A of the superior ends of the second conduit 4694B and / or the third conduit 4694C.

[0445] Figure 47 depicts an implementation of the fluid manifold 1442 including aplurality of conduits 4794A-4794E in another arrangement, according to another example. In this example, the fluid manifold 1442 includes a proximal manifold portion 4742A and a distal manifold portion 4742B that are configured to be coupled to each other to define the conduits 4794A-4794E. In other examples, the proximal manifold portion 4742A and the distal manifold portion 4742B can be integrally formed as a single, monolithic structure.

[0446] As shown in Figure 47, the conduits 4794A-4794E include a superior vertex 4794F, an inferior vertex 4794G, a first conduit 4694A extending between the superior vertex 4794F and the inferior vertex 4794G, a second conduit 4794B extending from the superior vertex 4694F in a first transverse direction toward the superior end 4563 and the first lateral side 4567, a third conduit 4794C extending from the superior vertex 4794F in a second transverse direction toward the superior end 4563 and the second lateral side 4569, a fourth conduit 4794D extending from the inferior vertex 4794G in a third transverse direction toward the inferior end 4565 and the first lateral side 4567, and a fifth conduit 4794E extending from the inferior vertex 4794G in a fourth transverse direction toward the inferior end 4565 and the second lateral side 4569. The proximal manifold portion 4742A includes the first aperture 1492A at (i) a superior end of the second conduit 4794B, (ii) a superior end of the third conduit 4794C, (iii) an inferior end of the fourth conduit 4794D, (iv) an inferior end of the fifth conduit 4794E, and (v) an intermediate portion of the first conduit 4794A between the superior vertex 4794F and the inferior vertex 4794G. The distal manifold portion 4742B includes the second aperture 1492B at a superior end of the first conduit 4794A (e.g., at or superior to the superior vertex 4794F).

[0447] Figure 48 depicts an implementation of the fluid manifold 1442 including a plurality of conduits 4894A-4894E in another arrangement, according to another example. In this example, the fluid manifold 1442 includes a proximal manifold portion 4842A and a distal manifold portion 4842B that are configured to be coupled to each other to define the conduits 4894A-4894E. In other examples, the proximal manifold portion 4842A and the distal manifold portion 4842B can be integrally formed as a single, monolithic structure.

[0448] As shown in Figure 48, the conduits 4894A-4894E include a superior vertex 4894F, an inferior vertex 4894G, a first conduit 4894A extending between the superior vertex 4894F and the inferior vertex 4894G, a second conduit 4894B extending from the superior vertex 4894F in a first transverse direction toward the inferior end 4565 and the first lateral side 4567, a third conduit 4894C extending from the superior vertex 4894F in a second transverse direction toward the inferior end 4565 and the second lateral side 4569, a fourthconduit 4894D extending from the inferior vertex 4894G in a third transverse direction toward the superior end 4563 and the first lateral side 4567, and a fifth conduit 4894E extending from the inferior vertex 4894G in a fourth transverse direction toward the superior end 4563 and the second lateral side 4569. The proximal manifold portion 4842A includes the first aperture 1492 A at (i) an inferior end of the second conduit 4894B, (ii) an inferior end of the third conduit 4894C, (iii) a superior end of the fourth conduit 4894D, (iv) a superior end of the fifth conduit 4894E, and (v) an inferior end of the first conduit 4894A. The distal manifold portion 4842B includes the second aperture 1492B at a superior end of the first conduit 4894A (e.g., at or superior to the superior vertex 4894F).

[0449] Figure 49 depicts an implementation of the fluid manifold 1442 including a conduit 4994 in another arrangement, according to another example. In this example, the fluid manifold 1442 includes a proximal manifold portion 4942A and a distal manifold portion 4942B that are configured to be coupled to each other to define the conduit 4994. In other examples, the proximal manifold portion 4942A and the distal manifold portion 4942B can be integrally formed as a single, monolithic structure.

[0450] As shown in Figure 49, the conduit 4994 has a triangle shape including a first superior vertex 4994 A, a second superior vertex 4994B, and an inferior vertex 4994C. Additionally, in Figure 49, the proximal manifold portion 4942A can include the first aperture 1492 A at (i) the first superior vertex 4994 A, (ii) the second superior vertex 4994B, (iii) the inferior vertex 4994C, and / or (iv) a central portion between the first superior vertex 4994A, the second superior vertex 4994B, and the inferior vertex 4994C. The distal manifold portion 4942B can include the second aperture 1492B at a location that is (i) between the first superior vertex 4994A and the second superior vertex 4994B, and (ii) superior to the first aperture 1494 A at the central portion.

[0451] Figure 50 depicts an implementation of the fluid manifold 1442 including a conduit 5094 in another arrangement, according to another example. In this example, the fluid manifold 1442 includes a proximal manifold portion 5042A and a distal manifold portion 5042B that are configured to be coupled to each other to define the conduit 5094. In other examples, the proximal manifold portion 5042A and the distal manifold portion 5042B can be integrally formed as a single, monolithic structure.

[0452] As shown in Figure 50, the conduit 5094 has a triangle shape including a superior vertex 5094A, a first inferior vertex 5094B, and a second inferior vertex 5094C.Additionally, in Figure 50, the proximal manifold portion 5042A can include the first aperture 1492A at (i) the first inferior vertex 5094B, (ii) the second inferior vertex 5094C, and / or (iii) a central portion between the superior vertex 5094A, the first inferior vertex 5094B, and the second inferior vertex 5094C. The distal manifold portion 5042B can include the second aperture 1492B at a location that is located at the superior vertex 5094A.

[0453] Figure 51 depicts an implementation of the fluid manifold 1442 including a a plurality of conduits 5194A-5194C in another arrangement, according to another example. In this example, the fluid manifold 1442 includes a proximal manifold portion 5142A and a distal manifold portion 5142B that are configured to be coupled to each other to define the conduits 5194A-5194C. In other examples, the proximal manifold portion 5142A and the distal manifold portion 5142B can be integrally formed as a single, monolithic structure.

[0454] As shown in Figure 51, the conduits 5194A-5194C include a first conduit 5194A on a first lateral side (e.g., the first lateral side of the fluid inlet 1430 as described above) and a second conduit 5194B on a second lateral side (e.g., the first lateral side of the fluid inlet 1430 as described above). In Figure 51, the conduits 5194A-5194C also include a third conduit 5194C that extends from an inferior recess 5194D in the distal manifold portion 5142B to a superior recess 5194E in the distal manifold portion 5142B. The proximal manifold portion 5142 A includes the first aperture 1492 A at (i) a location that overlies the superior recess 5194E, and (ii) a location that overlies the inferior recess 5194D when the proximal manifold portion 5142A is coupled to the distal manifold portion 5142B. The distal manifold portion 5142B includes the second aperture 1492B at a superior end of the first conduit 5194 A and the second conduit 5194B. This arrangement can help to enhance receiving urine into the conduits 5194A- 5194C at a center portion that is more superior to the inferior end 4565 than, for instance, examples that omit the superior recess 5194E and the third conduit 5194C.

[0455] In some examples described above, the spacer 1598, 2198, 4298 can be on a proximal side or a distal side of the fluid manifold 1442. In other examples, the fluid manifold 1442 can be disposed in or embedded in the spacer 1598, 2198, 4298. As one example, Figure 52 shows the fluid manifold 1442 disposed within a spacer 5298. The fluid manifold 1442 can be implemented according to any of the examples described above. Similarly, the spacer 5298 can be formed from any of the materials described above. In this example, the spacer 5298 can be entirely encases the fluid manifold 1442. In one implementation, the spacer 5298 can include a pocket 5271 and the fluid manifold 1442 can be received in the pocket 5271 through an opening 5273 in a side wall of the spacer 5298. Encasing the fluid manifold 1442 in thespacer 5298 can help to provide resistance to compression and / or reduce (or eliminate) gaps within the internal cavity of the urine diversion device. In other examples, a portion of the fluid manifold 1442 can extend through opening 5273 and out of the pocket 5271. This can reduce a cost of manufacture and / or facilitate ease of manufacture.

[0456] Figure 53 depicts a flowchart for a process 5300 of diverting urine, according to an example. At block 5310, the process 5300 includes positioning a urine diversion device on a user. The urine diversion device includes: (i) a liquid-impermeable backing, (ii) a user interface coupled to the liquid-impermeable backing, wherein the user interface is proximal of the liquid-impermeable backing, (iii) a fluid manifold between the liquid-impermeable backing and the user interface, (iv) an internal cavity between the fluid manifold and the user interface, and (v) a fluid inlet that is configured to receive a fluid through at least the user interface into the internal cavity. The fluid manifold includes a first aperture in fluid communication with the internal cavity, a second aperture that is coupled to a fluid outlet, and one or more conduits that extend from the first aperture to the second aperture.

[0457] At block 5312, the process 5300 includes coupling the fluid outlet of the urine diversion device to a vacuum device. At block 5314, the process 5300 includes applying, by the vacuum device, a vacuum pressure to the fluid outlet to cause the fluid manifold to evacuate the fluid from the internal cavity, through the first aperture, along the one or more conduits, and through second aperture to the fluid outlet.

[0458] Figure 54 depicts a flowchart for a process 5400 of making a urine diversion device, according to an example. At block 5410, the process 5400 includes forming a liquid- impermeable backing. At block 5412, the process 5400 includes coupling a user interface to the liquid-impermeable backing. The user interface is proximal of the liquid-impermeable backing. At block 5414, the process 5400 includes positioning a fluid manifold between the liquid-impermeable backing and the user interface such that an internal cavity is defined between the fluid manifold and the user interface. At block 5416, the process 5400 includes forming a fluid inlet that is configured to receive a fluid through at least the user interface into the internal cavity.

[0459] The fluid manifold includes a first aperture in fluid communication with the internal cavity, a second aperture that is coupled to a fluid outlet, and one or more conduits that extend from the first aperture to the second aperture. The fluid manifold is configured such that, responsive to a vacuum pressure applied to the fluid outlet, the fluid manifold evacuatesthe fluid from the internal cavity, through the first aperture, along the one or more conduits, and through second aperture to the fluid outlet.

[0460] 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 the embodiments, 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 liquid-impermeable backing; a user interface coupled to the liquid-impermeable backing, wherein the user interface is proximal of the liquid-impermeable backing; a fluid manifold between the liquid-impermeable backing and the user interface; an internal cavity between the fluid manifold and the user interface; and a fluid inlet that is configured to receive a fluid through at least the user interface into the internal cavity, wherein the fluid manifold comprises a first aperture in fluid communication with the internal cavity, a second aperture that is coupled to a fluid outlet, and one or more conduits that extend from the first aperture to the second aperture, and wherein, responsive to a vacuum pressure applied to the fluid outlet, the fluid manifold is configured to evacuate the fluid from the internal cavity, through the first aperture, along the one or more conduits, and through second aperture to the fluid outlet.

2. The urine diversion device of claim 1, wherein the fluid manifold comprises a proximal manifold portion and a distal manifold portion, and wherein the first aperture is in the proximal manifold portion.

3. The urine diversion device of claim 2, wherein the distal manifold portion comprises one or more channels that extend between the first aperture and the second aperture, wherein the proximal manifold portion covers the one or more channels to define the one or more conduits.

4. The urine diversion device of claim 3, further comprising one or more reinforcing members positioned in the one or more channels of the fluid manifold to resisting buckling of the one or more channels when stress is applied to the urine diversion device.

5. The urine diversion device of any one of claims 2-4, wherein the second aperture is in the distal manifold portion.

6. The urine diversion device of any one of claims 2-5, wherein the one or more conduits comprise a first conduit on a first lateral side of the fluid inlet and a second conduit on a second lateral side of the fluid inlet.

7. The urine diversion device of any one of claims 2-6, wherein the fluid manifold has lateral sides that are thinner in a dimension extending between the proximal manifold portion and the distal manifold portion than a center portion of the fluid manifold.

8. The urine diversion device of any one of claims 1-7, wherein the fluid outlet comprises a suction port coupling the second aperture of the fluid manifold to a whip tube.

9. The urine diversion device of claim 8, wherein the suction port comprises a 90 degree bend.

10. The urine diversion device of claim 8, wherein the suction port is configured to couple the whip tube to the second aperture at an acute angle with respect to a superior end of the urine diversion device.

11. The urine diversion device of any one of claims 1-10, further comprising a shape retaining element in the internal cavity.

12. The urine diversion device of claim 11, wherein the shape retaining element comprises a wire embedded in the fluid manifold or a plate of malleable material.

13. The urine diversion device of any one of claims 1-12, further comprising a gasket that extends around at least a portion of the fluid inlet.

14. The urine diversion device of any one of claims 1-13, wherein the user interface comprises the gasket, and wherein the gasket is U-shaped.

15. The urine diversion device of any one of claims 1-14, further comprising one or more layers of a wicking material in the internal cavity.

16. The urine diversion device of claim 15, further comprising a hydrophobic top sheet that is between the one or more layers of the wicking material and the fluid inlet.

17. The urine diversion device of any one of claims 1-16, further comprising a spacer between the user interface and the liquid-impermeable backing.

18. The urine diversion device of claim 17, wherein the spacer comprises an aperture that is aligned with the fluid inlet.

19. The urine diversion device of claim 17, wherein the spacer comprises a proximal spacer portion and a distal spacer portion, wherein the proximal spacer portion and the distal spacer portion are coupled to each other at an interface between the proximal spacer portion and the distal spacer portion, and wherein the proximal spacer portion is a first foam having a first pore size, the distal spacer portion is a second foam having a second pore size, and the first pore size is smaller than the second pore size.

20. The urine diversion device of any one of claims 1-19, wherein the liquid- impermeable backing includes a plurality of ribs that extend laterally between a plurality of lateral walls of the urine diversion device.

21. The urine diversion device of any one of claims 1-20, further comprising an attachment member, wherein the attachment member comprises a first lateral portion, a second lateral portion, an intermediate portion between the first lateral portion and the second lateral portion, and a bridge portion that extends from the first lateral portion to the second lateral portion and over the intermediate portion, wherein the intermediate portion and the bridge portion define a channel that is configured to receive a tube, and wherein the first lateral portion and the second lateral portion comprise an adhesive. In this arrangement.

22. The urine diversion device of claim 21, wherein the attachment member comprises an axial retention mechanism that is configured to: (i) allow the attachment member to move relative to the tube when the attachment member is in the a state, and (ii) axial retain the tube in a fixed position relative to the attachment member when the attachment member is in a second state.

23. The urine diversion device of claim 22, wherein the attachment member comprises the adhesive on an inner surface of the channel, wherein the axial retention mechanism includes a release liner that extends through a lateral opening in the channel, wherein a portion of the release liner is between the adhesive in the channel and the tube, and prevents the adhesive from engaging the tube in the first state, wherein the release liner is configured to be removed from the adhesive in the channel and the channel is configured to be pressed against the tube to couple the attachment member to the tube.

24. The urine diversion device of claim 1, wherein the user interface comprises a proximal interface layer and a support layer, wherein the support layer is formed of a liquid impermeable material to provide a fluid barrier that defines, at least in part, a proximal boundary of the internal cavity.

25. The urine diversion device of claim 24, wherein the support layer is distal of the proximal interface layer.

26. The urine diversion device of claim 24, wherein the proximal interface layer is distal of the support layer.

27. A method of diverting urine comprising: positioning a urine diversion device on a user, wherein the urine diversion device comprises:(i) a liquid-impermeable backing,(ii) a user interface coupled to the liquid-impermeable backing, wherein the user interface is proximal of the liquid-impermeable backing,(iii) a fluid manifold between the liquid-impermeable backing and the user interface;(iv) an internal cavity between the fluid manifold and the user interface, and(v) a fluid inlet that is configured to receive a fluid through at least the user interface into the internal cavity, and(vi) wherein the fluid manifold comprises a first aperture in fluid communication with the internal cavity, a second aperture that is coupled to a fluid outlet, and one or more conduits that extend from the first aperture to the second aperture; coupling the fluid outlet of the urine diversion device to a vacuum device; and applying, by the vacuum device, a vacuum pressure to the fluid outlet to cause the fluid manifold to evacuate the fluid from the internal cavity, through the first aperture, along the one or more conduits, and through second aperture to the fluid outlet.

28. A method of making a urine diversion device comprising: forming a liquid-impermeable backing; coupling a user interface to the liquid-impermeable backing, wherein the user interface is proximal of the liquid-impermeable backing; positioning a fluid manifold between the liquid-impermeable backing and the user interface such that an internal cavity is defined between the fluid manifold and the user interface; and forming a fluid inlet that is configured to receive a fluid through at least the user interface into the internal cavity, wherein the fluid manifold comprises a first aperture in fluid communication with the internal cavity, a second aperture that is coupled to a fluid outlet, and one or more conduits that extend from the first aperture to the second aperture, and wherein the fluid manifold is configured such that, responsive to a vacuum pressure applied to the fluid outlet, the fluid manifold evacuates the fluid from the internal cavity, through the first aperture, along the one or more conduits, and through second aperture to the fluid outlet.

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