Patent ID: 12233003

DETAILED DESCRIPTION

Embodiments are directed towards fluid collection assemblies that include at least one length adjusting feature (“LAF”), fluid collection systems including the same, and methods of using the same. An example fluid collection assembly includes a fluid impermeable barrier. The fluid impermeable barrier includes a distal region, at least one proximal end region spaced from the distal region, and at least one intermediate portion extending from the distal region to the proximal end region. The fluid impermeable barrier also defines at least one LAF extending from the proximal end region towards the distal region. The LAF forms one or more lateral edges of the at least one intermediate portion. The LAF allows the length of the fluid collection assembly to change. The ability of the fluid collection assembly to change the length thereof allows a penis of a patient (i.e., an individual using the fluid collection assembly) to be disposed in preferential locations within the fluid collection assembly.

Condom male external catheters (“CMECs”) are devices that are configured to have a penis disposed therein and remove bodily fluids (e.g., urine) that are discharged from the penis. CMECs are generally configured to be used with any penis, regardless of size, to at least one of minimize inventory, allow the penis to become erect without compressing the erect penis, or to prevent the need to use different CMECs depending on whether the penis is flaccid or erect. As such, the CMECs may be configured to be used with penises that, when erect, exhibit an above average size (e.g., an erect penis exhibiting a length greater than 20 cm, measured from a tip of the penis, such as the urethral opening of the penis, to the location where the shaft meets the mons pubis) and, thus, the CMEC may exhibit a length that is greater than 8 inches. However, the CMECs may be used with buried penises, flaccid penises, and penises exhibiting average to below average sizes when erect. Due to the large length of the CMECs, CMECs may exhibit a large distance between the fluid outlet of the CMEC (which is typically at a distal end region of the CMEC) and the penis when the penis is buried, flaccid, or exhibits an average or below average size when erect. The large distance between the penis and the fluid outlet may allow the bodily fluids discharged from the penis to flow in the wrong direction (e.g., away from the fluid outlet) and allow for greater loss of vacuum when a vacuum is used to remove the bodily fluids from the CMECs. Bodily fluids flowing in the wrong direction and/or the loss of vacuum may prevent or inhibit the removal of the bodily fluids from the CMECs which may cause patient discomfort (i.e., the patient remains in contact with the bodily fluids), create unsanitary conditions, and increase the likelihood that the bodily fluids leak from the CMECs.

The fluid collection assemblies disclosed herein may resolve at least some of the above discussed issues of the CMECs. For example, the fluid collection assemblies may exhibit a maximum length that is sufficiently large that the fluid collection assemblies may be used with above average sized erect penises. The fluid collection assemblies may be positioned on a penis such that the urethral opening of the penis is adjacent or at least proximate to the fluid outlet and/or distal region of the fluid collection assemblies. The LAF allows the length of the fluid collection assembly to be effectively changed (e.g., reduced) such that the urethral opening of buried penises, flaccid penises, and erect penis exhibiting average or below average lengths may be positioned adjacent or at least proximate to the fluid outlet and/or the distal region. The LAF allows the portions of the fluid collection assembly to flare outwardly (e.g., increase a width thereof) or be folded to reduce the effective length of the fluid collection assembly. Thus, the LAF may reduce the distance from the urethral opening of the penis and the fluid outlet and/or distal region thereby inhibiting the bodily fluids flowing in the wrong direction and/or inhibiting loss of vacuum.

FIG.1Ais an isometric view of a fluid collection assembly100, according to an embodiment.FIGS.1B and1Care cross-sectional schematics of the fluid collection assembly100taken along planes1B-1B and1C-1C illustrated inFIG.1A, respectively, according to an embodiment. The fluid collection assembly100includes a distal region104, a proximal end region106, and an intermediate portion108extending from the distal region104to the proximal end region106. The fluid collection assembly100includes a fluid impermeable barrier102that forms at least a portion of the distal region104, the proximal end region106, and the intermediate portion108. The fluid impermeable barrier102also defines a chamber110, an opening112at the proximal end region106that allows a penis124(partially shown inFIG.1D) to be disposed in the chamber110, a fluid outlet114at or near the distal region104that allows bodily fluids to be removed from the chamber110, and at least one LAF extending from the proximal end region106to the distal region104. In the illustrated embodiment, the LAF is a slit116that extends from the proximal end region106to the distal region104. The LAF forms the lateral edges118of the intermediate portion108. The fluid collection assembly100also includes at least one porous material120disposed in the chamber110.

The distal region104is a portion of the fluid collection assembly100that is configured to have a urethral opening of the penis124disposed adjacent or at least proximate thereof. As such, the distal region104(e.g., the porous material120of the distal region104) may receive bodily fluids that are discharged from the urethral opening preferentially and/or before the other portions of the fluid collection assembly100. For example, a stream of bodily fluids that are omitted from the urethral opening may first contact the distal region104of the fluid collection assembly100though, it is noted, that the stream may contact other regions of the fluid collection assembly since the penis124may be flimsy when flaccid which may allow the bodily fluids to be omitted at a variety of angles even when the urethral opening is adjacent or proximate to the distal region104.

The distal region104includes a portion of the fluid collection assembly100that is spaced from proximal end region106and the lateral edges118of the intermediate portion108(e.g., the LAF is not present in the distal region104). For example, the proximal end region106and the lateral edges118represent locations through which the bodily fluids may leak from the chamber110. As such, spacing the distal region104from the proximal end region106and the lateral edges118may minimize the likelihood that the bodily fluids leak from the fluid collection assembly100.

In an embodiment, as illustrated, the distal region104is spaced substantially equidistantly from the all portions of the proximal end region106which decreases the likelihood that the bodily fluids may preferentially leak from one portion of the proximal end region106. In other words, the distal region104is located substantially in the middle of the fluid collection assembly100. In an embodiment, as shown inFIGS.7A and7B, the distal region104may not be substantially equidistantly spaced from all the portions of the proximal end region106. In other words, the distal region104is located off-center. However, in such an embodiment, the distal region104is still spaced from the proximal end region106and the lateral edges118to minimize leakage of the bodily fluids from the fluid collection assembly100.

In an embodiment, as shown, the distal region104may form a sump. The distal region104forms a sump when the intermediate portion108is fully flared (e.g., the length and maximum width of the fluid collection assembly100cannot be smaller and bigger, respectively) and pressed against a flat surface, the portions of the distal region104in addition to the fluid outlet114may protrude upwardly from the intermediate portion108. The sump provides a location for at least a portion of the glans (head) of the penis124to be disposed in. The sump may optionally provide a location for at least a portion of the shaft of the penis124to be disposed in. Providing a location for the glans of the penis to be positioned in may prevent inadvertently compressing the glans of the penis when the fluid collection assembly100is secured to the patient, as discussed in more detail below. Further, the sump may increase a distance from the urethral opening of the penis and the proximal end region106and the lateral edges118thereby decreasing the likelihood that the bodily fluids leak from the chamber110. In an embodiment, as shown, the sump may exhibit a hollow generally cylindrical shape which generally corresponds to the shape of the penis. In an embodiment, the sump may exhibit a non-cylindrical shape, such as a generally spherical or conical shape. In an embodiment, illustrated inFIG.8, the distal region104does not form a sump. In such an embodiment, the fluid outlet114may optionally protrude from the surface when the intermediate portion108is fully flared and pressed against the surface.

The fluid outlet114may be located on the distal region104since the urethral opening of the penis is positioned adjacent to or at least proximate to the distal region104thereby reducing the distance between the urethral opening and the fluid outlet114. However, it is noted that the fluid outlet114may be spaced from the distal region104. In an example, the fluid outlet114may be positioned on the intermediate portion108at a location that is proximate to (e.g., within about 8 cm, within about 6 cm, within about 5 cm, within about 4 cm, within about 3 cm, within about 2 cm, within about 1 cm, within about 0.5 cm, within 0.25 cm of) the distal region104. In an example, the fluid outlet114may be positioned at or near an expected gravimetric low point of the chamber110since at least some of the bodily fluids, once received by the porous material120, may generally flow in the direction of gravity and the distal region104may not be located at the gravimetric low point of the chamber110.

As previously discussed, the fluid collection assembly100includes an LAF. In the illustrated embodiment, the LAF includes a slit116that extends from the proximal end region106towards (e.g., to) the distal region104. The slit116is configured to control the length of the fluid collection assembly100. In particular, the slit116allows at least a portion of the intermediate portion108to be flared (e.g., a width thereof increased) and/or folded back onto the rest of the fluid collection assembly100. Flaring the intermediate portion108or folding the intermediate portion108back onto the rest of the fluid collection assembly100decreases the effective length of the fluid collection assembly100. As used herein, the effective length refers to the maximum distance the fluid collection assembly100may extend from a base of a penis124when at least a portion of the fluid collection assembly100is adjacent to the base of the penis124.

FIG.1Dis an isometric view of the fluid collection assembly100during use, according to an embodiment.FIG.1Dillustrates how the LAF (e.g., slit116) allows the length of the fluid collection assembly100to change.FIG.1Dillustrates a patient122having a penis124(partially obscured) that exhibits a length that is smaller than a maximum length of the fluid collection assembly100(e.g., a length of the fluid collection assembly100when no portion of the intermediate portion108is flared or folded). It is desirable for the urethral opening of the penis124to be disposed in, adjacent, or proximate to the distal region104for reasons previously discussed. The LAF allows the length of the fluid collection assembly100to be decreased such that the urethral opening of the penis124is in, adjacent, or proximate to the distal region104.

In an embodiment, as shown, the length of the fluid collection assembly100may be changed (e.g., decreased) by flaring at least a portion of the intermediate portion108. Flaring at least a portion of the intermediate portion108refers to increasing the width of at least a portion of the intermediate portion108. The portions of the intermediate portion108that flare are referred to as the flared portions126. For example, the width of the intermediate portion108may be increased until flared portion126is generally flat or exhibits a shape that generally corresponds to the shape of the region about the penis124(e.g., the mons pubis128, the thighs130, the testicles (not shown), or other anatomical feature about the penis124). The flared portion126may be formed by moving corresponding portions of the lateral edges118(i.e., portions of the lateral edges118that are adjacent to each other when the slit116is closed) of the intermediate portion108away from each other. That is, the flared portion126may be formed by increasing a distance between corresponding portions of the lateral edges118. Increasing the width of the flared portion126decreases the length of the fluid collection assembly100.

In an embodiment, the length of the fluid collection assembly100may be changed by folding at least a portion of the intermediate portion108back onto itself and/or onto the distal region104. In such an embodiment, folding the intermediate portion108may be formed, at least initially, by flaring at least a portion of the intermediate portion108to form a flared portion126. After forming the flared portion126, corresponding portions of the lateral edges118are brought back together (e.g., a distance between corresponding portions of the lateral edges118are decreased) such that an interior of at least a portion of the intermediate portion108faces outwardly. For example, folding the intermediate portion108may cause a portion of the porous material120to be exposed. In other words, the fluid impermeable barrier102of the portions of the intermediate portion108that were initially flared are positioned proximate to the fluid impermeable barrier102of the portions of the fluid collection assembly100that were not flared.

The change in the length of the fluid collection assembly100is controlled by either flaring or folding all, some, or none of the intermediate portion108. In particular, increasing the percentage of the intermediate portion108that is flared or folded decreases the length of the fluid collection assembly100. For example, flaring or folding none of the intermediate portion108maintains the maximum length of the fluid collection assembly100, flaring or folding all of the intermediate portion108minimizes the length of the collection assembly100, and flaring or folding only a portion of the intermediate portion108causes the fluid collection assembly100to exhibit a length that is between the maximum and minimum length. When only a portion of the intermediate portion108is flared or folded, greater than 0% to about 20%, about 10% to about 30%, about 20% to about 40%, about 30% to about 50%, about 40% to about 60%, about 50% to about 70%, about 60% to about 80%, about 70% to about 90%, or about 80% to about 99% of a length of the intermediate portion108may be flared or folded. Whether all, none, or only some of the intermediate portion108is flared or folded may be selected based on the size of the penis124that the fluid collection assembly100is used with so that the length of the fluid collection assembly100allows the urethral opening of the penis124to be positioned within, adjacent, or proximate to the distal region104.

In an embodiment, the fluid collection assembly100may exhibit a maximum length that is greater than about 14 cm, such as about 14 cm to about 16 cm when configured to be used with average or below average sized penises only or greater than 16 cm (e.g., about 16 cm to about 20 cm or about 18 cm to about 22 cm) when configured to be used with substantially all penises. The maximum length is the maximum distance from the distal region104to the proximal end region106. The fluid collection assembly100may exhibit a final length after at least a portion of the intermediate portion108is flared or folded. The final length is less than the maximum length. For example, the final length may be 0 (the distal region104does not include a sump) to about 2 cm, about 1 cm to about 3 cm, about 2 cm to about 4 cm, about 3 cm to about 5 cm, about 4 cm to about 6 cm, about 5 cm to about 7 cm, about 6 cm to about 8 cm, about 7 cm to about 9 cm, about 10 cm to about 12.5 cm, about 12 cm to about 15 cm, or about 14 cm to about 20 cm. The final length may be the minimum length of the fluid collection assembly100or a length between the maximum length and the minimum length.

In an embodiment, as previously discussed, none or only a portion of the intermediate portion108may be flared or folded. In such an embodiment, the fluid collection assembly100may include at least one retainer132. The retainer132may be configured to prevent unflared or folded portions of the intermediate portion108from flaring or folded (e.g., prevent a distance between corresponding portions of the lateral edges118that do not form part of the flared portion126from increasing). For example, the retainer132may maintain the lateral edges118adjacent (e.g., abutting) to each other or overlap portions of the intermediate portion108, either of which may minimize leakage through the slit116. The retainer132may be positioned on (e.g., attached to, disposed on, fitted around) an exterior surface134of the fluid impermeable barrier102thereby preventing or at least inhibiting the distance between the corresponding portions lateral edges118adjacent to retainer132or between the retainer132and the distal region104from increasing. As such, the retainer132may inhibit a length of the fluid collection assembly100from changing after positioning the retainer132on the exterior surface134. In an example, the retainer132may maintain the lateral edges118adjacent (e.g., abutting) to each other.

In an example, the retainer132may cause the unflared or unfolded portions of the intermediate portions108to overlap. Overlapping the unflared or unfolded portions of the intermediate portions108may cause the fluid collection assembly100to clasp a shaft of the penis124thereby facilitating attachment of the fluid collection assembly100to the patient122. Overlapping the unflared or unfolded portions of the intermediate portions108may also decrease the volume of the chamber110, thereby increasing the likelihood that the bodily fluids discharged into the chamber110are received into the porous material110instead of leaking. Other structures that may be used to clasp against the shaft of the penis134, thereby facilitating attachment of the fluid collection assembly100to the patient122are disclosed in U.S. Provisional Patent Application No. 63/133,892 filed on Jan. 5, 2021, the disclosure of which is incorporated herein, in its entirety, by this reference.

The retainer132may include any device that may prevent the distance between corresponding portions of the lateral edges118adjacent to the retainer132and/or between the retainer132and the distal region104from increasing. In an example, the retainer132may include tape that is disposed across the slit116. In an example, the retainer132may include a sleeve (e.g., ring) that fits around the exterior surface134. The sleeve may not be adhesively attached to the exterior surface134of the fluid impermeable barrier102and, instead, may rely on friction to maintain the sleeve on the exterior surface134. In an example, the retainer132may include a Velcro strap that is attached to and/or extends around the exterior surface134. In an example, the retainer132may include an elastic band, rope or other string, or any other suitable device.

The intermediate portion108is defined by at least the distal region104, the proximal end region106, and the lateral edges118of the intermediate portion108. The shape of the intermediate portion108may depend whether the intermediate portion108is unflared or flared. For example, the intermediate portion108may exhibit a generally cylindrical shape when the intermediate portion108is unflared, a generally truncated cylindrical shape when the intermediate portion108is flared, and a generally flat shape when the intermediate portion108is completely flared. The intermediate portion108may exhibit other shapes, such as a generally rectangular shape, a generally semi-cylindrical shape, at least a portion of a generally parallelepiped shape, or any other suitable shape.

In an embodiment, the intermediate portion108is configured to attach the fluid collection assembly100to the patient122. In such an embodiment, at least a portion of the intermediate portion108includes an adhesive (e.g., hydrogel) on an interior surface137of the fluid impermeable barrier104or the interior surface136of the porous material120. The adhesive may be configured to attach the intermediate portion108to the shaft of the penis and/or the region about the penis124thereby securing the fluid collection assembly100to the patient. In an example, the portions of the fluid impermeable barrier102that form a portion of the interior surface137(e.g., the inwardly extending portion146and/or the chamber portion148) may include the adhesive. In an example, at least a portion of the porous material120that forms the interior surface136includes the adhesive. In an example, only portions of the interior surface136adjacent or proximate to the proximal end region106and the lateral edges118include the adhesive. In such an example, the adhesive may be configured to form a seal that prevents the bodily fluids from flow out of the chamber110.

Referring back toFIGS.1A-1C, as previously discussed, the fluid collection assembly100includes a fluid impermeable barrier102. The fluid impermeable barrier102temporarily stores the bodily fluids discharged from a penis in the chamber110. The fluid impermeable barrier102stores the bodily fluids in the chamber110. The fluid impermeable barrier102may be formed of any suitable fluid impermeable material(s), such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, a polycarbonate, etc.), a metal film, natural rubber, another suitable material, or combinations thereof. As such, the fluid impermeable barrier102substantially prevents the bodily fluids from passing through the fluid impermeable barrier102. In an example, the fluid impermeable barrier102may be air permeable and fluid impermeable. In such an example, the fluid impermeable barrier102may be formed of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least an exterior surface134of the fluid impermeable barrier102may be formed from a soft and/or smooth material, thereby reducing chaffing.

The fluid impermeable barrier102at least partially defines the chamber110. For example, the interior surface137of the fluid impermeable barrier102at least partially defines the perimeter of the chamber110. The chamber110may at least temporarily retain fluids therein. In an example, portions of the chamber110may be substantially empty due to the varying sizes and rigidity of the male penis. However, in some examples, the outermost regions of the chamber110may include porous material120(e.g., one or more of the fluid permeable membrane138and fluid permeable support140). For example, the porous material120may be bonded to at least a portion of the interior surface137of the fluid impermeable barrier102. The porous material120may be positioned (e.g., at the distal end of the chamber110) to blunt a stream of urine from the male urethra thereby limiting splashing and/or to direct the bodily fluids to a selected region of the chamber110. Since the chamber110is substantially empty, the fluids are likely to pool at a gravimetrically low point of the chamber110. The gravimetrically low point of the chamber110may be at an intersection of the skin of a patient and the fluid collection assembly100, the distal region104, or another suitable location depending on the orientation of the patient. It is noted that the varying length of the fluid collection assembly100may allow the penis to substantially completely occupy any portions of the chamber110that are not occupied by the porous material120or that forms the reservoir152. Substantially completely occupying such portions of the chamber110may position the porous material120adjacent to the urethral opening, thereby causing the porous material120to receive substantially all of the bodily fluids discharged from the urethral opening and prevent the bodily fluids remaining in the unoccupied portions of the chamber110.

The fluid impermeable barrier102may also define an opening112extending through the fluid impermeable barrier102that is configured to have the penis124positioned therethrough. The opening112may be defined by the portions of the fluid impermeable barrier102that form the proximal end region106. For example, the opening112is formed in an extends through the fluid impermeable barrier102, from the exterior surface134to the interior surface137, thereby enabling the penis124and bodily fluids (e.g., when the penis124is buried) to enter the chamber110. The opening112may also be formed in and extend through the porous material120.

In some examples, the fluid impermeable barrier102may define the fluid outlet114that is sized to receive the conduit142. The at least one conduit142may be disposed in the chamber110via the fluid outlet114. The fluid outlet114may be sized and shaped to form an at least substantially fluid tight seal against the conduit142or the at least one tube thereby substantially preventing the bodily fluids from escaping the chamber110.

The porous material120may include one or more of the fluid permeable membrane138or the fluid permeable support140. One or more of the fluid permeable membrane138or the fluid permeable support140may be disposed between the fluid impermeable barrier102and a penis inserted into the chamber110. The fluid permeable membrane138may be positioned between the fluid impermeable barrier102and a penis inserted into the chamber110, such as between the fluid permeable support140and penis of a patient as shown. The fluid permeable support140may be positioned between the fluid permeable membrane138and the fluid impermeable barrier102. The interior surface137, optionally including the end of the chamber110substantially opposite the opening112, may be covered with one or both the fluid permeable membrane138or the fluid permeable support140. The fluid permeable support140or the fluid permeable membrane138may be affixed (e.g., adhered) to the fluid impermeable barrier102. The fluid permeable support140or the fluid permeable membrane138may be affixed to each other.

The fluid collection assembly100includes assembly porous material120disposed in the chamber110. The assembly porous material120may cover at least a portion (e.g., all) of the opening112. The assembly porous material120may include a fluid permeable membrane138and a fluid permeable support140. The assembly porous material120is exposed to the environment outside of the chamber110through the opening112. In an embodiment, the assembly porous material120may be configured to wick any bodily fluids away from the opening112, thereby preventing the bodily fluids from escaping the chamber110. The permeable properties referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as “permeable” and/or “wicking.” Such “wicking” and/or “permeable” properties may not include absorption of the bodily fluids into at least a portion of the wicking material, such as not include adsorption of the bodily fluids into the fluid permeable support140. Put another way, substantially no absorption or solubility of the bodily fluids into the material may take place after the material is exposed to the bodily fluids and removed from the bodily fluids for a time. While no absorption or solubility is desired, the term “substantially no absorption” may allow for nominal amounts of absorption and/or solubility of the bodily fluids into the wicking material (e.g., absorbency), such as less than about 30 wt % of the dry weight of the wicking material, less than about 20 wt %, less than about 10 wt %, less than about 7 wt %, less than about 5 wt %, less than about 3 wt %, less than about 2 wt %, less than about 1 wt %, or less than about 0.5 wt % of the dry weight of the wicking material. The porous material may also wick the bodily fluids generally towards an interior of the chamber110, as discussed in more detail below. In an embodiment, the assembly porous material120may include at least one absorbent or adsorbent material.

The fluid permeable membrane138may be composed to wick the bodily fluids away from the opening112, thereby preventing the bodily fluids from escaping the chamber110. The fluid permeable membrane138may include any material that may wick the bodily fluids. For example, the fluid permeable membrane138may include fabric, such as a gauze (e.g., a silk, linen, or cotton gauze), another soft fabric, or another smooth fabric. Forming the fluid permeable membrane138from gauze, paper, soft fabric, and/or smooth fabric may reduce chaffing caused by the fluid collection assembly100. In an embodiment, the fluid permeable membrane138may become quickly saturated with the bodily fluids after the porous material120received the bodily fluids from the penis. The fluid permeable membrane138may become substantially impermeable to gases when the fluid permeable membrane138becomes saturated with the bodily fluids thereby preventing or at least minimizing loss of a vacuum through the fluid permeable membrane138. Preventing or minimizing the loss of the vacuum through the fluid permeable membrane138may increase the quantity of and rate at which the bodily fluids are removed from the chamber110.

The fluid collection assembly100may include the fluid permeable support140disposed in the chamber110. The fluid permeable support140is configured to support the fluid permeable membrane138since the fluid permeable membrane138may be formed from a relatively foldable, flimsy, or otherwise easily deformable material. For example, the fluid permeable support140may be positioned such that the fluid permeable membrane138is disposed between the fluid permeable support140and the fluid impermeable barrier102. As such, the fluid permeable support140may support and maintain the position of the fluid permeable membrane138. The fluid permeable support140may include any material that may wick or be permeable to the bodily fluids, such as any of the fluid permeable membrane materials disclosed herein above. For example, the fluid permeable membrane material(s) may be utilized in a more dense or rigid form than in the fluid permeable membrane138when used as the fluid permeable support140. The fluid permeable support140may be formed from any fluid permeable material that is less deformable than the fluid permeable membrane138. For example, the fluid permeable support140may include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open cell foam, such as spun nylon fiber. In some examples, the fluid permeable support140may be formed from a natural material, such as cotton, wool, silk, or combinations thereof. In an example, the fluid permeable support140may include a nonwoven material or a woven material (e.g., spun nylon fibers). In some examples, the fluid permeable support140may be formed from fabric, felt, gauze, or combinations thereof.

In an embodiment, the fluid permeable support140may be hydrophobic. The fluid permeable support140may be hydrophobic when the fluid permeable support140exhibits a contact angle with water (a major constituent of bodily fluids) that is greater than about 90°, such as in ranges of about 90° to about 120°, about 105° to about 135°, about 120° to about 150°, about 135° to about 175°, or about 150° to about 180°. The hydrophobicity of the fluid permeable support140may limit absorption, adsorption, and solubility of the bodily fluids in the fluid permeable support140thereby decreasing the amount of bodily fluids held in the assembly porous material120. In an embodiment, the fluid permeable membrane138is hydrophobic or hydrophilic. In an embodiment, the fluid permeable support140is more hydrophobic (e.g., exhibits a larger contact angle with water) than the fluid permeable membrane138. The lower hydrophobicity of the fluid permeable membrane138may help the assembly porous material120receive the bodily fluids from the urethral opening while the hydrophobicity of the fluid permeable support140limits the bodily fluids that are retained in the assembly porous material120.

In some examples, the fluid permeable membrane138may be optional. For example, the porous material120may include only the fluid permeable support140. In some examples, the fluid permeable support140may be optionally omitted from the fluid collection assembly100. For example, the porous material120may only include the fluid permeable membrane138. In some examples, the porous material120may include one or more additional layers in addition to or instead of at least one of the fluid permeable membrane138or the fluid permeable support140.

In an embodiment, at least a portion of the porous material120at or near the proximal end region106may exhibit a tube-like structure (not shown) extending circumferentially about the proximal end region between the LAF. The tube-like structure of the porous material may include the fluid permeable membrane138rolled up into a generally curved cylindrical shape that may or may not define a channel. The fluid permeable support140may surround the fluid permeable membrane138. Examples of a porous material120that exhibits a tube-like structure is disclosed in U.S. Pat. No. 10,376,406 filed on Jul. 27, 2016, the disclosure of which is disclosed herein, in its entirety, by this reference.

In an embodiment, the porous material120may be adjacent to substantially all of the interior surface137of the fluid impermeable barrier102such that there are substantially no gaps between the porous material120and the fluid impermeable barrier102ignoring the inherent porosity of the porous material120. In an embodiment, the porous material120may not be adjacent to one or more portions of the interior surface137of the fluid impermeable barrier102. In such an embodiment, the chamber110includes at least one reservoir152that is a substantially unoccupied portion of the chamber110that is between the fluid impermeable barrier102and the porous material120. The bodily fluids that are in the chamber110may flow through the porous material120to the reservoir152. The reservoir152may retain the bodily fluids therein until the bodily fluids are removed from the chamber110. The reservoir152is depicted in the distal region104since the fluid outlet114is at or near the distal region104. However, the reservoir152may be located in any portion of the chamber110between the fluid impermeable barrier102and the porous material120, such as the proximal end region106. The reservoir152may be located adjacent or proximate to the fluid outlet114or a gravimetrically low point of the fluid collection assembly100when the fluid collection assembly100is worn.

The fluid impermeable barrier102and the porous material120may be configured to prevent leaks from the chamber110. In an example, the fluid impermeable barrier102may be configured such that the fluid impermeable barrier102that defines at least a portion of the lateral edges118contact each other when the when the slit116is closed (e.g., the lateral edges118contact each other or a portion of the intermediate portion108overlaps another portion of the intermediate portion108). The fluid impermeable barrier102contacting itself prevents the formation of gaps through which the bodily fluids may leak and vacuum may be lost. In an example, as previously discussed, the fluid permeable membrane138may be configured to be substantially impermeable to gas when the fluid permeable membrane138becomes saturated with the bodily fluids. The saturated fluid permeable membrane138decreases vacuum loss which pulls the bodily fluids towards the fluid outlet114, inhibits movement of the bodily fluids towards the slit116and the opening112, and increases the quantity and rate at which the bodily fluids are removed from the chamber110.

In an example, the fluid impermeable barrier102at least partially covers (e.g., extends around at least a portion of) one or more edges144of the porous material120. In such an example, the fluid impermeable barrier102may include at least one inwardly extending portion146extending inwardly from a portion of the fluid impermeable barrier102that extends generally parallel to the porous material120. The fluid impermeable barrier102may optionally include includes at least one chamber portion148extending from the inwardly extending portion146into the chamber110. The inwardly extending portion146and/or the chamber portion148of the fluid impermeable barrier102form at least one of at least a portion of the proximal end region106(e.g., define a portion of the opening112) or at least a portion of the lateral edges118. The inwardly extending portion may prevent or at least inhibit bodily fluids from flowing out of the porous material120through the edges144thereof. The inwardly extending portion may also prevent or at least inhibit the vacuum being lost through the edges144of the porous material120. The inwardly extending portion146and the chamber portion148of the fluid impermeable barrier102may also form a channel150that may store bodily fluids that reach the proximal end region106or the lateral edges118. The bodily fluids stored in the channel150may be pulled from the channel150as bodily fluids are removed from the chamber110due to hydrogen bonding. The inwardly extending portion146and/or the chamber portion148may also increase contact between the fluid impermeable barrier102when the slit116is closed and/or a portion of the intermediate portion108overlaps another portion of the intermediate portion108. The increased contact between the fluid impermeable barrier102reduces the likelihood that the bodily fluids leak through the slit116.

The conduit142may be used to remove the bodily fluids from the chamber110. The conduit142(e.g., a tube) includes an inlet154and an outlet (not shown) positioned downstream from the inlet154. The outlet may be operably coupled to a vacuum source, such as a vacuum pump for withdrawing fluid from the chamber110through the conduit142. For example, the conduit142may extend into the fluid impermeable barrier102from to the fluid outlet114to a point proximate to the reservoir152therein such that the inlet154is in fluid communication with the reservoir152. The conduit142fluidly couples the chamber110with the fluid storage container (not shown) or the vacuum source (not shown).

The conduit142may include a flexible material such as plastic tubing (e.g., medical tubing). Such plastic tubing may include a thermoplastic elastomer, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc., tubing. In some examples, the conduit142may include silicon or latex. In some examples, the conduit142may include one or more portions that are resilient, such as to by having one or more of a diameter or wall thickness that allows the conduit to be flexible.

As described in more detail below, the conduit142is configured to be coupled to, and at least partially extend between, one or more of the fluid storage container (not shown) and the vacuum source (not shown). In an example, the conduit142is configured to be directly connected to the vacuum source (not shown). In such an example, the conduit142may extend from the fluid impermeable barrier102by at least one foot, at least two feet, at least three feet, at least six feet, or at least eight feet. In another example, the conduit142is configured to be indirectly connected to at least one of the fluid storage container (not shown) and the vacuum source (not shown). In some examples, the conduit is secured to a patient's skin with a catheter securement device, such as a STATLOCK® catheter securement device available from C. R. Bard, Inc., including but not limited to those disclosed in U.S. Pat. Nos. 6,117,163; 6,123,398; and 8,211,063, the disclosures of which are all incorporated herein by reference in their entirety.

The inlet154and the outlet are configured to fluidly couple (e.g., directly or indirectly) the vacuum source (not shown) to the chamber110(e.g., the reservoir152). As the vacuum source (FIG.9) applies a vacuum/suction in the conduit142, the bodily fluids in the chamber110(e.g., at the distal region104, such as in the reservoir152) may be drawn into the inlet154and out of the fluid collection assembly100via the conduit142. In some examples, the conduit may be frosted or opaque (e.g., black) to obscure visibility of the bodily fluids therein.

The slit116illustrated inFIGS.1A-1Dis merely one example of the LAF that may be included in any of the fluid collection assemblies disclosed herein.FIG.2Ais a side elevational view of a fluid collection assembly200that includes a LAF other than at least one slit, according to an embodiment.FIG.2Bis a cross-sectional schematic of the fluid collection assembly200taken along plane2B-2B illustrated inFIG.2A, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly200is the same of substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly200includes a distal region204, a proximal end region206, at least one intermediate portion208extending from the distal region204to the proximal end region206, and at least one LAF. The fluid collection assembly also includes a fluid impermeable barrier202defining a chamber210and at least one porous material220disposed in the chamber210.

The LAF of the fluid collection assembly200includes a plurality of perforations216that extend through at least a portion of the fluid impermeable barrier202. The perforations216may be arranged in a path, such as a substantially straight path. The plurality of perforations216may extend from the proximal end region206to the distal region204. The perforations216weaken the fluid impermeable barrier202such that the fluid impermeable barrier202is configured to tear along the path. Tearing the fluid impermeable barrier202along the path formed by the perforations216forms a slit that functions substantially similar to the slit116illustrated inFIGS.1A-1D.

The slit formed using the perforations216does not need to extend the whole length of the path formed by the perforations216. Instead, the slit formed using the perforations216may only extend a portion of the length of the path depending on the size of the penis that the fluid collection assembly200is used with. For example, the slit formed using the perforations216may only extend about greater than 0% to about 20%, about 10% to about 30%, about 20% to about 40%, about 30% to about 50%, about 40% to about 60%, about 50% to about 70%, about 60% to about 80%, about 70% to about 90%, or about 80% to about 100% the length of the path formed by the perforations216. The percentage of the length of the path that the slit extends may be selected based on the length of the path, the maximum length of the fluid collection assembly100, the final length of the fluid collection assembly200, and the length of the penis. Only tearing the a portion of the path formed by the protrusion216allows the slit to exhibit a length that was specifically selected for a specific sized penis. In other words, the length of the slit formed from the perforations may be selected to only be as large as necessary. The selected length of the slit formed from the perforations216may exhibit a length that is less than the slit116illustrated inFIGS.1A-1Dthereby decreasing the likelihood that the bodily fluids leak from the chamber210.

Referring toFIG.2B, the perforations216may only extend a portion of a distance through the fluid impermeable barrier202. Only extending the perforations216through a portion of the fluid impermeable barrier202may prevent bodily fluids leaking through perforations216that were not torn. When the fluid impermeable barrier202includes two inwardly extending portions246, the perforations216may be positioned between the two inwardly extending portions246.

The LAF may include features other than a slit or a plurality of perforations. In an example, the LAF may include a portion of the fluid collection assembly that is weakened, such as by selectively thinning a portion of one or more components of the fluid collection assembly or forming a portion of one or more components of the fluid collection assembly from a weaker, more easily tear-able material. The weakened portions may facilitate tearing of a portion of the fluid collection assembly similar to the plurality of perforations. In an example, the LAF may include a flexible material that extends across a recess that extends through the fluid impermeable barrier and porous material. The flexible material and the recess allows the intermediate portion of the fluid collection assembly to flare but the flexible material may prevent or at least inhibit flow of bodily fluids through the recess. In an example, the LAF may include a combination of any of the LAFs disclosed herein, such as a slit and a plurality of protrusions extending from the slit towards the distal region.

Referring back toFIG.1B, the inlet154of the conduit142is positioned to be within the fluid inlet114, within the fluid reservoir152, or adjacent to the porous material120that is in or adjacent to the distal region104. The inlet154of the conduit142may facilitate removal of the bodily fluids from the chamber110when the distal region104is or near the gravimetric low point of the chamber110. For example, the bodily fluids received by the porous material120may predominately flow in the direction of gravity towards the distal region104which allows the conduit142to remove the bodily fluids. The conduit142may still remove bodily fluids when the distal region104is not at or near the gravimetric low point of the chamber110. For example, the conduit142may still receive some of the bodily fluids and the bodily fluids received by the conduit142may pull additional quantities of the bodily fluids into the conduit142due to hydrogen bonding. However, the conduit142may be unable to remove bodily fluids from portions of the chamber110spaced from the distal region104when the porous material120is not saturated with bodily fluids and when the distal region104is not at or near the gravimetric low point of the chamber110.

As such, the fluid collection assemblies disclosed herein may include positioning the inlet of the conduit at or near the expected gravimetric low point of the chamber even when the expected gravimetric low point of the chamber is not at or near the distal region. In an embodiment, the fluid outlet of the fluid collection assembly may be at or near the gravimetric low point of the chamber and spaced from the distal region. In an embodiment, as illustrated inFIGS.3A and3B, the conduit may extend from the fluid outlet that is spaced from the expected gravimetric low point to a location in the chamber that is at or near the expected gravimetric low point.

FIG.3Ais a cross-sectional schematic of a fluid collection assembly300, according to an embodiment.FIG.3Bis a cross-sectional schematic of the fluid collection assembly300taken along plane3B-3B shown inFIG.3A, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly300may be the same or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly300may include distal region304, a proximal end region306, at least one intermediate portion308extending from the distal region304to the proximal end region306, and at least one LAF316. The fluid collection assembly300may also include a fluid impermeable barrier302defining at least a chamber310and a fluid outlet314. The fluid collection assembly300may further includes at least one porous material320disposed in the chamber310.

In an embodiment, the gravimetric low point of the chamber310is expected to be at a location that is spaced from the fluid outlet314. For example, the fluid outlet314may be located at or near the distal region304of the fluid collection assembly300while the gravimetric low point of the chamber310is expected to be at or near the proximal end region306. It is noted that the fluid outlet314may be located at a location other than the distal region304(e.g., the intermediate portion308and/or near the proximal end region306). It is also noted that the gravimetric low point of the chamber310may be at a location other than near the proximal end region306depending on at least one of the position of the patient (e.g., standing, sitting, or lying down) and/or the direction that the penis extends when the penis is erect or flaccid.

The conduit342may extend from the fluid outlet314to the expected gravimetric low point of the chamber310such that the inlet354of the conduit342is at or near the expected gravimetric low point. For example, in the illustrated embodiment, the conduit342may extend from the fluid outlet314, at least one of between the fluid impermeable barrier302and the porous material320, through the porous material320(e.g., through a bore formed in the porous material320), or in an unoccupied spaced defined partially by the porous material320that also receives the penis (not shown). Positioning the inlet354of the conduit342at or near the expected gravimetric low point of the chamber310may facilitate removal of the bodily fluids from the chamber310since at least some of the bodily fluids may flow towards the gravimetric low point of the chamber310.

In an embodiment, the chamber310may include a substantially unoccupied space at or near the proximal end region306or any other location that may be expected to be the gravimetric low point of the chamber310. The substantially unoccupied space may be a reservoir352that is configured to temporarily store the bodily fluids therein.

In an embodiment, the conduit of any of the fluid collection assemblies disclosed herein may define a plurality of inlets thereby allowing the conduit to receive bodily fluids from a variety of locations in the chamber. In an embodiment, the conduit of any of the fluid collection assemblies disclosed herein may include a plurality of conduits and an inlet of at least one of the plurality of conduits is positioned in a location that is different than an inlet of at least one other one of the plurality of conduits thereby allowing the conduits to receive bodily fluids from a variety of locations in the chamber.

The fluid collection assemblies illustrated inFIGS.1A-3Bare illustrated as including only a single intermediate portion. However, it is noted that the fluid collection assemblies disclosed herein may include any suitable number of intermediate portions, such as 2 intermediate portions, 3 intermediate portions, 4 intermediate portions, 5 intermediate portions, or 6 or more intermediate portions. Each of the plurality of intermediate portions may be separated by an LAF (e.g., slit, perforations, etc.).

FIG.4Ais an isometric view of a fluid collection assembly400that includes a two intermediate portions408, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly400is the same or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly400may include a distal region404and proximal end regions406spaced from the distal region404. The fluid collection assembly400also includes a fluid impermeable barrier402defining at least a chamber410and at least one porous material420disposed in the chamber410.

The fluid collection assembly400includes two intermediate portions408each extending from the distal region404to the proximal end regions406. The two intermediate portions408are separated from each other by two LAFs416. In the illustrated embodiment, the two intermediate portions408may be generally aligned linearly and/or may extend generally parallel to each other as the two intermediate portions408extend from the distal region404. However, the two intermediate portions408may also extend from the distal region404while not being at least one of generally aligned linearly with each other or generally parallel to each other.

The intermediate portions408may be the same or substantially similar to any of the intermediate portions disclosed herein. For example, the intermediate portions408may include a fluid impermeable barrier402and at least one porous material420disposed adjacent to at least a portion of the fluid impermeable barrier402of each of the intermediate portions408. The intermediate portions408may also exhibit any shape disclosed herein. For example, the intermediate portions408may exhibit a generally rectangular shape, a generally semi-cylindrical shape, a generally parallelepiped shape, or any other suitable shape.

In an embodiment, the two intermediate portions408are substantially the same. For example, the two intermediate portions408may exhibit the same size, the same shape, etc. In an embodiment, the two intermediate portions408may be different from each other in one or more aspects. For example, the intermediate portions408may exhibit different sizes, different shapes, one of the intermediate portions408may include a porous material420that is different than a porous material420of the other intermediate portion408, one intermediate portion408may include a reservoir and/or a conduit extending therethrough while the other intermediate portion408does not, one intermediate portion408may include the fluid outlet414, etc.

FIG.4Bis an isometric view of the fluid collection assembly400during use, according to an embodiment. The penis (patient not shown for clarity) may be disposed in the chamber410such that the penis is adjacent or at least proximate to the distal region404. At least a portion of intermediate portions408may be flared (as shown) or folded to reduce the length of the fluid collection assembly400such that the penis is within, adjacent or at least proximate to the distal region404. The fluid collection assembly400may include a retainer432to prevent or at least inhibit the unflared portions of the intermediate portions408from flaring.

In an embodiment, the flared portions426of the intermediate portions408may be flared outwardly until each of the flared portions426exhibits a shape that generally corresponds to the shape of the region about the penis that the flared portions426contact. The portions of the body that the flared portions426correspond to may depend on the orientation (e.g., rotation) of the fluid collection assembly400exhibit relative to the patient. In an example, the flared portions426may be flared until at least a portion of the flared portions426exhibit a shape that generally corresponds to the shape of the thighs of the patient. In an example, the flared portions426may be flared until at least a portion of the flared portion426of one of the intermediate portions408exhibit a shape that generally corresponds to the shape of at least a portion of the testicles of the patient while the flared portion426of the other intermediate portions408exhibits a shape that generally corresponds to the shape of the mons pubis. In an embodiment, the flared portions426may be flared such that the flared portions426do not exhibit a shape that corresponds to the shape of the region about the penis. For example, the flared portions426may be folded upwardly such that at least a portion of the fluid impermeable barrier402of the flared portions426is adjacent to the fluid impermeable barrier402of at least a portion of the rest of the fluid collection assembly400.

As previously discussed, the fluid collection assembly400includes two intermediate portions. However, any of the fluid collection assemblies disclosed herein may include more than two intermediate portions, such as three intermediate portions as illustrated inFIGS.5A-5C.FIG.5Ais an isometric view of a fluid collection assembly500, according to an embodiment.FIG.5Bis a top plan view of the fluid collection assembly500, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly500may be the same or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly500may include a distal region504, proximal end regions506spaced from the distal region504, three intermediate portions508, and at least one LAF516disposed between each of the three intermediate portions508. For illustrative purposes, the intermediate portions508are illustrated as being flared though, it is noted, the intermediate portions508may not be flared. The fluid collection assembly500also includes a fluid impermeable barrier502and at least one porous material (not shown).

As previously discussed, the fluid collection assembly500includes three intermediate portions508. The three intermediate portions508allows the fluid collection assembly500to be attached to more regions of the body of the patient that is using the fluid collection assembly500than if the fluid collection assembly500only included one or two intermediate portions. In an example, the three intermediate portions308allows the fluid collection assembly500to be attached to the two thighs and the mons pubis of the patient. Allowing the fluid collection assembly500to be attached to more portions of the bodily causes the fluid collection assembly500to pull less on each portion of the patient thereby increasing patient comfort In an example, the three intermediate portions508allows two of the intermediate portions508to be attached above the penis (i.e., in a region generally between the penis and head of the patient) or to the side of the penis while the remaining intermediate portion508may be attached below the penis (i.e., in a region generally between the penis and the feet of the patient). In an example, the three intermediate portions508allows two of the intermediate portions508to be attached below or to the sides of the penis while the remaining intermediate portion508may be attached above the penis. In an embodiment, the three intermediate portions508may minimize pivoting and increase the likelihood that the fluid collection assembly500stays attached to the patient than if the fluid collection assembly500included fewer intermediate portions.

The three intermediate portions508may allow the fluid collection assembly500to be attached to the patient without attaching one or more of the intermediate portions508to sensitive portions of the patient (e.g., testicles) compared to a fluid collection assembly that includes two or fewer intermediate portions. In an example, the intermediate portions508may be attached to the mons pubis without also attaching the intermediate portions508to the testicles whereas attaching one of the intermediate portions408of the fluid collection assembly400illustrated inFIG.4Ato the mons pubis may also cause the other intermediate portion to be attached to the testicles. In an example, the fluid collection assembly500may be positioned on the patient such that one of the intermediate portions508may be attached to the testicles.

It is noted that generally, increasing the number of intermediate portions increases the comfort of using the fluid collection assembly by increasing the number of locations to which the intermediate portions may be attached while also avoiding more sensitive portions of the patient.

Referring toFIG.5B, the intermediate portions508may be “equidistantly spaced” when each angle θ between two adjacent lateral edges518of different intermediate portions508are the same or substantially the same. In the illustrated embodiment, the angle θ is about 120° when the three intermediate portions508are equidistantly spaced. Equidistantly spacing intermediate portions508may allow each of the intermediate portions508to more equally carry the weight of the fluid collection assembly500when the intermediate portions508are attached to the patient as the patient moves. It is noted that the other fluid collection assemblies disclosed herein may have their intermediate portions equidistantly spaced. In an example, the fluid collection assembly400illustrated inFIGS.4A and4Bmay have equidistantly spaced intermediate portions408when the angle between the two intermediate portions is about 180° (i.e., aligned linearly). In an example, a fluid collection assembly with four equidistantly spaced intermediate portions has an angle between adjacent set of intermediate portions that is about 90°, a fluid collection assembly with five equidistantly spaced intermediate portions has an angle between adjacent set of intermediate portions that is about 72°, and so forth.

The intermediate portions of any of the fluid collection assemblies disclosed herein may have non-equidistantly spaced intermediate portions (e.g., an angle between two adjacent lateral edges of a first set of two different intermediate portions is different than an angle between two other adjacent lateral edges of a second set of two different intermediate portions). For example,FIG.5Cis a top plan view of a fluid collection assembly500′ that includes a plurality of intermediate portions508′ that are not equidistantly spaced, according to an embodiment. The fluid collection assembly500′ is similar to any of the fluid collection assemblies disclosed herein (e.g., the fluid collection assembly500illustrated inFIGS.5Aand5B) in one or more aspects. For example, the fluid collection assembly500′ includes a plurality (e.g., three) intermediate portions508′. However, unlike the other fluid collection assemblies disclosed herein, the intermediate portions508′ are not equidistantly spaced. For example, an angle θ is measure between adjacent lateral edges518′ of two different intermediate portions508′ and an angle α is measured between other adjacent lateral edges518′ of two different intermediate portions508′, where the angle θ and the angle α are different. The angles between the other adjacent set of intermediate portion(s) may be the same or different than at least one of the angle θ and the angle α.

The angle θ and the angle α may be selected such that the intermediate portions508′ are attached to selected portions of the body and/or avoid certain portions of the body. For example, the angle θ may be selected such that the intermediate portions508′ that the angle θ is measured between avoids the testicles. For instance, the angle θ may be selected to be about 120° to about 200° (e.g., about 180°) thereby allowing the corresponding set of adjacent intermediate portions508′ are attached to the thighs instead of the testicles. The angle α may be selected such that one of the intermediate portions508′ that the angle α is measured between contacts the mons pubis or another location other than the testicles. As such, the angle θ and the angle α are selected to avoid attaching or contacting one of the intermediate portions508′ against the testicles.

In some embodiments, the intermediate portions of any of the fluid collection assemblies disclosed herein may overlap. For example,FIG.6is an isometric view of a fluid collection assembly600that includes overlapping intermediate portions608, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly600is the same of substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly600includes a distal region604, proximal end regions606spaced from the distal region604, and a plurality of intermediate portions608extending from the distal region604to the proximal end regions606.

As previously discussed, the fluid collection assembly600includes a plurality of intermediate portions608and at least a portion of at least some of the plurality of intermediate portions608overlap with each other. The intermediate portions608overlap when one intermediate portion608covers a portion of another intermediate portion608(e.g., an adjacent intermediate portion608) when the intermediate portions608are completely flared. The overlapping intermediate portion608generally covers a portion of the adjacent intermediate portion608that is adjacent to the distal region604.

The overlapping of the intermediate portions608prevents or at least inhibits bodily fluids from leaking from the chamber (not shown) of the fluid collection assembly600. For example, one of the more likely locations of the fluid collection assembly600that the bodily fluids may leak from is through the LAF adjacent to the distal region604. In fluid collection assemblies that do not include overlapping intermediate portions, any bodily fluids that flow around the lateral edge of an intermediate portion adjacent to the distal region may be able to leak from the such a fluid collection assembly. However, in the fluid collection assembly600illustrated inFIG.6, the bodily fluids that flow around a lateral edge618of a first intermediate portion608that is adjacent to the distal region604must flow between the first intermediate portion608and the intermediate portion608that overlaps the first intermediate portion608without being received by the porous material before the bodily fluids may leak from the fluid collection assembly600. As such, the overlapping intermediate portions608decrease the likelihood that the bodily fluids leak from the fluid collection assembly600than if the intermediate portions608did not overlap.

In an embodiment, all of the intermediate portions608are partially overlapped by another intermediate portion608and, by extension, all of the intermediate portions608partially overlap another intermediate portion608. In an embodiment, at least one of the intermediate portions608is overlapped by two intermediate portions adjacent intermediate portion608. In an embodiment, at least one of the intermediate portion608is not overlapped and/or does not overlap another intermediate portion608.

The fluid collection assemblies illustrated inFIGS.1A-6are illustrated as having 1, 2, 3, or 5 intermediate portions. However, the fluid collection assemblies disclosed herein may include any number of intermediate portions. For example, the fluid collection assemblies disclosed herein may include 4 or 6 or more intermediate portions. It is noted that it is generally believed that increasing the number of intermediate portions beyond 6 may adversely affect the operation of the fluid collection assembly. For instance, increasing the number of intermediate portions of a fluid collection assembly beyond 6 may make attaching the fluid collection assembly patient without attaching the intermediate portions to themselves or to the wrong portion of the patient difficult. Further, increasing the number of intermediate portions of the fluid collection assembly beyond 6 may increase the chances of bodily fluids leaking from the fluid collection assembly due to the number of LAFs through which the bodily fluids may leak.

The fluid collection assemblies illustrated inFIGS.4A-6include intermediate portions that extend a substantially equal distance from the distal regions thereof. However, the fluid collection assemblies disclosed herein may include intermediate portions that do not extend a substantially equal distance from the distal regions thereof, as shown inFIGS.7A-7B. The fluid collection assembly that includes intermediate portions that do not extend a substantially equal distance from the distal regions thereof may allow such a fluid collection assembly to be positioned against the penis that would be difficult to do if the intermediate portions extended a substantially equal distance from the distal region.FIG.7Ais an isometric view of a fluid collection assembly700, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly700is the same or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly700includes a distal region704, proximal end regions706spaced from the distal region704, and a plurality of intermediate portions extending from the distal region704to the proximal end region706.

The fluid collection assembly700includes a first intermediate portion708aand a second intermediate portion708b. The first intermediate portion708aextends a first distance from the distal region704and the second intermediate portion708bextends a second distance from the distal region704, wherein the second distance is greater than the first distance. In other words, the first intermediate portion708aexhibits a length that is less than a length of the second intermediate portion708b. As will be discussed in more detail with regards toFIG.7B, the different lengths of the first and second intermediate portion708a,708bmay facilitate attachment of the fluid collection assembly700to a penis724(shown inFIG.7B).

The proximal end region706formed by the first intermediate portion708aor a portion of the first intermediate portion708aadjacent to the proximal end region706is configured to abut or at least partially surround the penis724(shown inFIG.7B). For example, some of the bodily fluids discharged from the penis724into the chamber710(shown inFIG.7B) may flow down the shaft757of the penis724or the penis may lay on either side rather than straight up. The portion(s) of the first intermediate portion708athat abut or at least partially surround the penis724may receive or at least maintain in the chamber710at least some of the bodily fluids that flow down the shaft757of the penis724or receive bodily fluids that otherwise remain on the shaft. Thus, the portion(s) of the first intermediate portion708athat abut or at least partially surround the penis724may minimize leakage of bodily fluids from the chamber710.

In an embodiment, the first intermediate portion708amay define a cutout756. The cutout756may extend inwardly from (as shown) from the proximal end region706or may be a hole proximate the proximal end region706that is completely surrounded by the first intermediate portion708. The cutout756is configured to receive the penis724such that the first intermediate portion708apartially surrounds (when the cutout756extends inwardly from the proximal end region706) or completely surrounds (when the cutout756is a hole) the penis724. The cutout756allows the first intermediate portion708ato be adjacent to or abut more of the penis724than if the first intermediate portion708adid not include the cutout756. As such, the cutout756allows the first intermediate portion708ato receive or at least maintain in the chamber710more of the bodily fluids that if the first intermediate portion708adid not include the cutout756.

FIG.7Bis a cross-sectional schematic of the fluid collection assembly700being used with a penis724, according to an embodiment. As shown, the first intermediate portion708ais positioned adjacent to or abuts the penis724, such as the shaft757or the base758of the penis724. When the first intermediate portion708aincludes a cutout756, the penis724may be at least partially positioned in the cutout756. The urethral opening (e.g., glans760) of the penis724is positioned within or adjacent to the distal region704such that bodily fluids discharged from the urethral opening may be preferentially received by the distal region704and removed from the chamber710using the fluid outlet714. A portion of the second intermediate portion708bmay then be positioned adjacent to an opposing side of the shaft757of the penis724than the first intermediate portion708a. The portion of the second intermediate portion708bthat is not adjacent to the shaft757of the penis724may be positioned against the mons pubis728of the patient. As illustrated inFIG.7B, the second intermediate portion708bmay travel a longer distance from the distal region704than the first intermediate portion708aand, for this reason, the second intermediate portion708bmay exhibit a length that is greater than the first intermediate portion708a. A portion of the first intermediate portion708a(e.g., edges of the first intermediate portion708a) and a portion of the second intermediate portion708b(e.g., edges of the second intermediate portion708b) may be attached together or at least positioned adjacent to each other to minimize bodily fluids leaking between the first and second intermediate portions708a,708b.

The fluid collection assemblies illustrated inFIGS.1A-7Bare illustrated as including a distal region that is a sump. However, in some embodiments, the fluid collection assemblies disclosed herein may include a distal region that is not a sump. For example,FIG.8is an isometric view of a fluid collection assembly800that includes a distal region804that is not a sump, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly800is the same or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly800may include the distal region804, at least one proximal end region806, and at least one intermediate portion808extending from the distal region804to the proximal end region806.

As previously discussed, the distal region804of the fluid collection assembly800is not a sump. Such a distal region804may allow the fluid collection assembly800to lie flat on a surface or otherwise conform to the shape of a surface. The ability of the fluid collection assembly800to lie flat on a surface or otherwise conform to the shape of the surface may allow the fluid collection assembly800to be more effectively used with a buried penis. For example, the distal region804of the fluid collection assembly800may lie flat across the buried penis thereby allowing the urethral opening to be positioned closer to the fluid outlet814than if the distal region804included a sump. It is noted that a fluid collection assembly may still be used with a buried penis if the distal region thereof is a sump but that the sump may increase the distance between the urethral opening of the buried penis and the fluid outlet.

The at least one intermediate portion808of the fluid collection assembly800allows the fluid collection assembly800to be used with non-buried penises. For example, at least a portion of the lateral edges818may be positioned together thereby allowing the intermediate portion808in conjunction with the distal region804to form a sump-like shape. The non-buried penis may be disposed in the sump-like shape.

It is noted that the fluid outlet814may extend outwardly from the rest of the fluid collection assembly800when the fluid collection assembly800lies flat. Extending the fluid outlet814outwardly from the rest of the fluid collection assembly800may facilitate attaching the conduit842thereto. However, the fluid outlet814is too small to form a sump in which the glans of the penis may be positioned therein. Thus, the fluid collection assembly800may include a distal region804that is not a sump but also include a fluid outlet814extending outwardly from the rest of the fluid collection assembly800.

FIG.9is a block diagram of a fluid collection system901for fluid collection, according to an embodiment. The fluid collection system901includes a fluid collection assembly900that is similar or identical to any of the fluid collection assemblies disclosed herein in one or more aspects. The fluid collection system901also includes a fluid storage container907, and a vacuum source909. The fluid collection assembly900, the fluid storage container907, and the vacuum source909may be fluidly coupled to each other via one or more conduits942. For example, fluid collection assembly900may be operably coupled to one or more of the fluid storage container907or the vacuum source909via the conduit942. Bodily fluids (e.g., urine or other bodily fluids) collected in the fluid collection assembly900may be removed from the fluid collection assembly900via the conduit942which protrudes into the fluid collection assembly900. For example, an inlet of the conduit942may extend into the fluid collection assembly900, such as to a reservoir therein. The outlet of the conduit942may extend into the fluid storage container907or the vacuum source909. Suction force may be introduced into the chamber of the fluid collection assembly900via the inlet of the conduit942responsive to suction (e.g., vacuum) force applied at the outlet of the conduit942.

The suction force may be applied to the outlet of the conduit942by the vacuum source909either directly or indirectly. The suction force may be applied indirectly via the fluid storage container907. For example, the outlet of the conduit942may be disposed within the fluid storage container907and an additional conduit942may extend from the fluid storage container907to the vacuum source909. Accordingly, the vacuum source909may apply suction to the fluid collection assembly900via the fluid storage container907. The suction force may be applied directly via the vacuum source909. For example, the outlet of the conduit942may be disposed within the vacuum source909. An additional conduit942may extend from the vacuum source909to a point outside of the fluid collection assembly900, such as to the fluid storage container907. In such examples, the vacuum source909may be disposed between the fluid collection assembly900and the fluid storage container907.

The fluid storage container907is sized and shaped to retain the bodily fluids therein. The fluid storage container907may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing bodily fluids such as urine. In some examples, the conduit942may extend from the fluid collection assembly900and attach to the fluid storage container907at a first point therein. An additional conduit942may attach to the fluid storage container907at a second point thereon and may extend and attach to the vacuum source909. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection assembly900via the fluid storage container907. Fluid, such as urine, may be drained from the fluid collection assembly900using the vacuum source909.

The vacuum source909may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum. The vacuum source909may provide a vacuum or suction to remove fluid from the fluid collection assembly900. In some examples, the vacuum source909may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even manual power (e.g., a hand operated vacuum pump). In some examples, the vacuum source909may be sized and shaped to fit outside of, on, or within the fluid collection assembly900. For example, the vacuum source909may include one or more miniaturized pumps or one or more micro pumps. The vacuum sources909disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the vacuum source909.

The fluid collection assemblies disclosed herein are discussed as being used with a penis. For example, the fluid collection assemblies are disclosed as being positioned on, around, or above a penis. However, it is noted that the fluid collection assemblies disclosed herein may collect bodily fluids from anatomy other than a penis. In an embodiment, the fluid collection assemblies disclosed herein may be positioned on, around, or above a female urethral opening (e.g., vaginal) thereby allowing the fluid collection assemblies to remove urine, blood, vagina discharge, or other relevant bodily fluids from the vagina. In an embodiment, the fluid collection assemblies disclosed herein may be positioned on, around, or above a wound thereby allowing the fluid collection assemblies to receive and remove blood, puss, serous fluid, or other relevant bodily fluids from the wound. In an embodiment, the fluid collection assemblies may be disposed on any other anatomical feature of a patient to remove moisture, oil, or other bodily fluids from the anatomical feature, such as a finger of a surgeon.

While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting.

Terms of degree (e.g., “about,” “substantially,” “generally,” etc.) indicate structurally or functionally insignificant variations. In an example, when the term of degree is included with a term indicating quantity, the term of degree is interpreted to mean±10%, ±5%, or ±2% of the term indicating quantity. In an example, when the term of degree is used to modify a shape, the term of degree indicates that the shape being modified by the term of degree has the appearance of the disclosed shape. For instance, the term of degree may be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more perforations extending therefrom, is oblong, is the same as the disclosed shape, etc.