Male fluid collection assembly and method of manufacture

Abstract

An example fluid collection assembly includes a sheath and a base. The sheath includes a fluid impermeable barrier including a proximal region and a distal region extending from the proximal region, the proximal region defining an opening and the distal region defining a fluid outlet. The fluid impermeable barrier defines at least the outlet. The fluid impermeable barrier includes a first panel and a second panel sealed to the first panel along a perimeter of the first and second panels. A portion of the perimeter includes a seal configured to releasably seal the perimeter of the first and second panels. The sheath further includes at least one porous material disposed in a chamber. The base is configured to be secured to the proximal region of the sheath. The base is configured to be attached to skin surrounding a penis, the base defining an aperture corresponding to the opening of the sheath.

Description

Background Technology

[0001] In various circumstances, a person may have limited or impaired mobility, making the typical urination process challenging or impossible. For example, a person may experience or have a disability that impairs mobility. A person may have limited mobility conditions, such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, urine collection is sometimes necessary for monitoring purposes or clinical testing.

[0002] Urinary catheters, such as Foley catheters, can be used to manage some of these conditions, such as incontinence. Unfortunately, catheters can be uncomfortable, painful, and can lead to complications such as infections. Additionally, bedpans are sometimes used as containers for bedridden patients (such as those in healthcare facilities) to use the toilet. However, bedpans can easily lead to discomfort, spills, and other hygiene problems.

[0003] Men suffering the most severe consequences of urinary incontinence (such as discomfort, rashes, and sores) are typically older and often bedridden. They require ongoing assistance to maintain hygiene. Common characteristics found in these patients include: they are usually supine; penile size often decreases with age; skin folds containing adipose tissue cause penile retraction; and the penis often points upwards when lying down, making it difficult for the patient to access the penis and manipulate the device. Urine collection devices should be designed with these characteristics in mind.

[0004] Therefore, there is a need for an improved device capable of collecting urine from men. Summary of the Invention

[0005] The embodiments disclosed herein relate to male fluid collection assemblies, systems including the same, and methods of using the same. In one embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a sheath. The sheath includes at least one fluid-impermeable barrier, the at least one fluid-impermeable barrier including a proximal region and a distal region extending from the proximal region, the proximal region defining a first opening and the distal region defining a fluid outlet, the fluid-impermeable barrier at least defining a chamber. The fluid-impermeable barrier includes a first panel and a second panel, the second panel being sealed to the first panel along the periphery of the first and second panels. A portion of the periphery may include a seal configured to releasably seal the periphery of the first and second panels. The sheath also includes at least one porous material disposed within the chamber. The fluid collection assembly also includes a base configured to be secured to the proximal region of the sheath, the base being configured to be attached to the skin surrounding the penis, the base defining an orifice corresponding to the opening of the sheath.

[0006] In some embodiments, the fluid collection assembly may include a sheath. The sheath may include a fluid-impermeable barrier having a proximal region and a distal region extending from the proximal region, the proximal region defining an opening and the distal region defining a fluid outlet, the fluid-impermeable barrier at least defining a chamber. In some examples, at least one porous material may be disposed in the chamber, the porous material comprising a flexible sheet having a proximal edge and a distal edge, the proximal edge being fixed to the proximal region of the fluid-impermeable barrier, and the distal edge being movable between an extended position and a retracted position. The fluid collection assembly also includes an actuator connected to the distal edge of the flexible sheet, the actuator being configured to move the porous material between the extended and retracted positions. The fluid collection assembly also includes a base fixed to or configured to be fixed to the proximal region of the sheath, the base being configured to be attached to skin surrounding the penis, the base defining an orifice corresponding to the opening of the sheath.

[0007] In some embodiments, a method of collecting bodily fluids from an individual using a system may include attaching a base of a fluid collection device to the skin surrounding the penis, the base being fixed to or configured to be fixed to a sheath defining an orifice corresponding to an opening of the sheath. The sheath may include a fluid-impermeable barrier having a proximal region and a distal region extending from the proximal region, the proximal region defining an opening and the distal region defining a fluid outlet, the fluid-impermeable barrier at least defining a chamber. At least one porous material may be disposed in the chamber, the porous material comprising a flexible sheet having a proximal edge and a distal edge, the proximal edge being fixed to the proximal region of the fluid-impermeable barrier, and the distal edge being movable between an extended position and a retracted position. The method may further include receiving fluid discharged by the user into the fluid collection device, and receiving fluid discharged from the fluid collection device into a fluid collection container. Attached Figure Description

[0008] The accompanying drawings illustrate several embodiments of the present disclosure, wherein the same reference numerals refer to the same or similar elements or features in different views or embodiments shown in the drawings.

[0009] Figure 1 and 2 These are, respectively, top isometric views and bottom isometric views of a fluid collection assembly according to one embodiment.

[0010] Figures 3A to 3C This is a schematic cross-sectional view of a fluid collection assembly according to one embodiment.

[0011] Figure 4 This is an isometric view of a fluid collection assembly having a seal that opens along the periphery of the first and second panels, according to one embodiment.

[0012] Figure 5A and5B This is an isometric view of a fluid collection assembly according to one embodiment, the fluid collection assembly having a porous material comprising a flexible sheet movable between an extended position and a retracted position.

[0013] Figure 6 This is a block diagram of a fluid collection system according to one embodiment.

[0014] Figure 7 This is a flowchart of a method for collecting fluid according to one embodiment. Detailed Implementation

[0015] The embodiments disclosed herein relate to male fluid collection components, systems including the same, methods of manufacturing the same, and methods of using the same. One example fluid collection component includes a sheath and a base. The sheath includes a fluid-impermeable barrier formed by at least a first panel and a second panel joined together. The fluid-impermeable barrier includes a proximal region and a distal region extending from the proximal region. The proximal region defines an opening, and the distal region defines a fluid outlet. The first and second panels define a chamber therebetween. The first and second panels are sealed along the peripheries of the first and second panels. A portion of the periphery includes a clamping seal. The sheath also includes at least one porous material disposed within the chamber. The base can be configured to be secured to the proximal region of the sheath. The base defines an orifice corresponding to the opening of the sheath. The base is configured to be attached to the skin surrounding the penis of an individual, wherein the penis extends through the opening and into the chamber. Thus, the chamber of the sheath can be configured to receive bodily fluids (e.g., urine, semen, sweat, etc.) from the penis.

[0016] An example method of using a fluid collection assembly includes attaching a base to the skin surrounding the penis of an individual. The base is positioned on the individual such that the penis extends through an orifice defined by the base. The base can be secured to or configured to be secured to a sheath. In some examples, the sheath can also be permanently attached to the base. For example, the sheath can be permanently attached to the base before, during, or after securing the base to the area surrounding the penis. After the base is secured to the area surrounding the penis and the sheath is attached to the base, the individual can expel bodily fluids from the penis. In some examples, the fluid collection assembly includes at least one porous material disposed in a chamber. The porous material can include a flexible sheet having a proximal edge and a distal edge, the proximal edge being secured to a proximal region of a fluid-impermeable barrier, and the distal edge being movable between an extended position and a retracted position. Bodily fluids enter the chamber of the sheath, and the method includes receiving fluids expelled from the user into the fluid collection device. Skin examination can be performed on the individual or user by separating the base from the sheath or by withdrawing an actuator coupled to the distal edge of the porous material. The actuator may include a lever. When the lever is withdrawn, the individual's genitals are exposed through a fluid-impermeable barrier. The lever is then able to return, and the porous material returns to its extended position. The porous material can receive at least some of the bodily fluid entering the chamber and guide the bodily fluid toward the outlet. This method can receive fluid discharged from the user into a fluid collection device and fluid discharged from the fluid collection device into a fluid collection container, for example, by applying suction force to the outlet via a vacuum source by drawing a vacuum through a conduit in fluid communication with the fluid outlet of the fluid collection device using a pump, thereby effectively drawing fluid from the fluid collection device and into the fluid collection container.

[0017] Figure 1 and Figure 2These are isometric top and bottom views, respectively, of a fluid collection assembly 100 according to one embodiment. The fluid collection assembly 100 includes a sheath 102 and a base 104. The sheath 102 includes a fluid-impermeable barrier 106, which is at least partially formed by a first panel 108 attached to a second panel 110. The fluid-impermeable barrier 106 further defines a chamber 112 between the first panel 108 and the second panel, an opening 114 at a proximal region 116 of the sheath 102, and an outlet 118 at a distal region 120 of the sheath 102. In other words, the fluid-impermeable barrier 106 includes a proximal region 116 and a distal region 120 extending from the proximal region 116, the proximal region 116 defining the opening 114, and the distal region 120 defining the fluid outlet 118. The sheath 102 also includes at least one porous material 122 disposed in the chamber 112. The base 104 includes an orifice 124. The base 104 is configured to be attached and / or secured to the proximal region 116 of the sheath 102 such that the orifice 124 of the base 104 is aligned with the opening 114 of the sheath 102. In some examples, the sheath 102 can be detached from the base 104 without damaging at least one of the sheath 102 or the base 104, thereby enabling skin examination. The sheath may include a port attached to a fluid outlet 118, the port including a first portion defining an inlet and a second portion defining an outlet, the second portion being configured to attach to a catheter 146, as described in more detail below.

[0018] Figure 2 The second panel 110 defines the entire opening 114. For example, the opening 114 is a cut defined by the second panel 110, which is spaced apart from the periphery of the second panel 110. In such an example, the second panel 110 may have a shape that substantially corresponds to the shape of the first panel 108, which can facilitate attaching the first panel 108 to the second panel 110 along the outer edges of the first panel 108 and the second panel 110. This also allows the first panel 108 and the second panel 110 to be substantially flat when the penis is not in the chamber 112, which can make the wearable fluid collection assembly 100 more discreet and prevent the accumulation of bodily fluids against the body volume.

[0019] Reference Figures 3A to 3CThe inner surface 126 of the fluid-impermeable barrier 106 (e.g., the inner surfaces of the first and second panels 108, 110) at least partially defines a chamber 112 within the fluid collection assembly 100. The fluid-impermeable barrier 106 temporarily stores bodily fluids within the chamber 112. The fluid-impermeable barrier 106 can be formed of any suitable fluid-impermeable material, such as fluid-impermeable polymers (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polycarbonate, etc.), another suitable material, or a combination thereof. Thus, the fluid-impermeable barrier 106 substantially prevents bodily fluids from passing through it. In one example, the fluid-impermeable barrier 106 can be air-permeable and fluid-impermeable, thereby preventing leakage when suction is applied while allowing airflow through the chamber 112 (i.e., the chamber 112 is maintained at approximately atmospheric pressure, thereby preventing suction injury to the skin or kinking of the catheter). In such an example, the fluid-impermeable barrier 106 can be formed of a hydrophobic material defining a plurality of pores. Alternatively or additionally, the fluid-impermeable barrier 106 may include at least one perforation (e.g., a vacuum release orifice) that allows the chamber 112 to be maintained substantially at atmospheric pressure. At least one or more portions of at least the outer surface 130 of the fluid-impermeable barrier 106 may be formed of a soft and / or smooth material to reduce abrasion.

[0020] In one embodiment, at least one of the first panel 108 or the second panel 110 is formed of a fluid-impermeable material that is at least partially transparent, such as polyethylene, polypropylene, or polycarbonate. In some examples, the fluid-impermeable barrier 106 may be formed of any suitable impermeable material. For example, the fluid-impermeable barrier 106 may be formed of polyurethane, polyethylene, polypropylene, other polymers, any other suitable impermeable material, or combinations thereof. Forming at least one of the first panel 108 or the second panel 110 of a fluid-impermeable material that is at least partially transparent allows a person (e.g., a medical practitioner) to examine the penis and / or perform a skin examination. In some embodiments, both the first panel 108 and the second panel 110 are formed of a fluid-impermeable material that is at least partially transparent. For example, some conventional fluid collection assemblies that include a sheath and a base may allow the sheath to be reversibly removed from the base after the base has been secured to the area around the penis. Removing the sheath from the base allows a person to examine the penis. In some examples, the sheath 102 may be permanently attached to the base 104, which essentially prevents leakage between the sheath 102 and the base 104 when the base 104 is properly attached to the sheath 102 (e.g., wrinkles are not allowed to form between the sheath 102 and the base 104). However, in order to enable skin examination, in some examples, the base 104 may be detached from the sheath 102.

[0021] Figure 3B The illustration shows a base 104 disconnected from the sheath 102. In some examples, the base may be releasably attached to a proximal region 116 of the sheath 102. For example, the interface between the base 104 and the sheath 102 may include an interference fit. In other words, as a press fit or a friction fit. An interference fit may be defined herein as a form of fastening between two closely fitting and / or mating parts that creates an engagement that is held together by friction after the parts are pushed together. In some examples, the sheath 102 and the base 104 may be twisted in a first direction (e.g., clockwise) to lock these parts together and twisted in a second direction (e.g., counterclockwise) to unlock these parts for use in skin examinations or for replacement of the sheath 102 or the base 104 due to dirt or deterioration. Refer back Figure 2 In some examples, the base 104 and the sheath 102 may include a fastener 128 configured to attach the base 104 and the sheath 102 and also align the orifice 124 with the opening 114.

[0022] The porous material 122 can be positioned to help maintain the dignity of the individual using the fluid collection assembly 100. For example, during use, the second panel 110 is typically adjacent to the individual, such as adjacent to the thigh and / or perineum. Therefore, the second panel 110 is typically obscured during use, and the penis cannot be seen without first lifting the sheath 102 from the individual. Meanwhile, the first panel 108 can be positioned away from the individual and is more easily seen than the second panel 110. However, a person (e.g., a passerby, visitor, etc.) cannot see the penis through the first panel 108 because the porous material 122 is not transparent. Therefore, in such an embodiment, the porous material 122 prevents one or more people from seeing the penis unless such examination is necessary, thereby maintaining the dignity of the individual using the fluid collection assembly 100. The porous material 122 is positioned between the penis and at least a portion of the first panel 108. In such an embodiment, a caregiver needs to move the porous material 122 to observe the chamber 112.

[0023] In one embodiment, the porous material 122 is a wicking material configured to wick any bodily fluid away from the opening 114, thereby preventing the bodily fluid from escaping from the chamber 112. This "wicking" may not include fluid absorption into the wicking material. In other words, after a period of time following the material's exposure to and removal from the fluid, the fluid is substantially not absorbed into the material. While absorption is not desired, the term "substantially not absorbed" may allow a nominal amount (e.g., absorbency) of fluid to be absorbed into the wicking material, such as 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 wicking material may also wick fluid generally toward the interior of the chamber 112, as discussed in more detail below. In one embodiment, the porous material 122 is configured to adsorb or absorb bodily fluid. Similar to the wicking material, this adsorbing or absorbing material can cause bodily fluid to move away from the opening 114, thereby preventing the bodily fluid from escaping from the chamber 112.

[0024] The porous material 122 can be formed from any suitable porous material. For example, the porous material 122 can be formed from nylon (e.g., spun nylon fibers), polyester, polyurethane, polyethylene, polypropylene, other porous polymers, hydrophobic foams, open-cell foams, wool, silk, linen, cotton (e.g., cotton yarn), felt, other fabrics, coated porous materials (e.g., waterproof-coated porous materials), any other suitable porous materials, or combinations thereof. For example, the porous material 122 may comprise a combination of a spun nylon inner layer and a fabric gauze outer layer that contacts the skin of an object.

[0025] In one embodiment, the porous material 122 may be a sheet. Forming the porous material 122 as a sheet can facilitate the manufacture of the fluid collection assembly 100. For example, forming the porous material 122 as a sheet allows the first panel 108, the second panel 110, and the porous material 122 to each be a sheet. During the manufacture of the fluid collection assembly 100, the first panel 108, the second panel 110, and the porous material 122 may be stacked and then attached to each other in the same manufacturing step. For example, the porous material 122 may have a shape that is the same as, or more preferably slightly smaller than, the first panel 108 and the second panel 110. Thus, attaching the first panel 108 and the second panel 110 together along the outer edges 134 of the first panel 108 and the second panel 110 can also attach the porous material 122 to the first panel 108 and the second panel 110.

[0026] Figure 4This is an isometric view of a fluid collection assembly 100 according to one embodiment, wherein a seal 132 is opened along the periphery of a first panel 108 and a second panel 110. As described above, the chamber 112 may include at least one porous material 122 disposed between the first panel 108 and the second panel 110. The at least one porous material 122 may be generally opaque and therefore needs to be moved to allow for skin examination of a patient. As previously described, the first panel 108 and the second panel 110 are attached together. In one embodiment, as shown, the first and second panels 108, 110 are attached together along at least a portion of their outer edges 134. In such embodiments, the first and second panels 108, 110 are attached using any suitable technique, such as using adhesives, sutures, heat sealing, radio frequency (“RF”) welding, ultrasonic (“US”) welding, or any other technique.

[0027] In some examples, opening 114 is a first opening, and seal 132 includes a two-part strip defining a second opening 133 that is sealed with an interference fit when the first panel 108 and the second panel 110 are pressed together and opens when the first panel 108 and the second panel 110 are pulled apart. In other words, a portion of the outer edge 134 of the first panel 108 and the second panel 110 is also attached by seal 132. Seal 132 includes a sealing strip at the outer periphery of the first panel 108 and the second panel 110. When opened, the user and / or caregiver can use both hands to pinch both the first panel 108 and the second panel 110 and pull outward to open the sealing strip of seal 132. In other words, the seal is configured to operate in the same or similar manner as a ZIPLOCK® seal. This opening method is relatively simple and convenient. In some examples, seal 132 may comprise a two-part strip defining an opening that is press-fitted together to seal the first panel 108 and the second panel 110 when pressed together, and opens when the first panel 108 and the second panel 110 are pulled apart. In other words, the first panel 108 includes strips, and the second panel 110 includes strips capable of sealing each other with an interference fit. These two strips are attached or molded into the inner surfaces 126 of the first panel 108 and the second panel 110, respectively. Concave strips and convex ribs that seal against each other are provided on opposite sides of the first panel 108 and the second panel 110p, and the concave strips and convex ribs are arranged in pairs to provide a fluid-impermeable seal 132. In other words, the seal may comprise grooves and ribs that engage with each other when pressed together. Thus, any fluid must pass through the mechanically interlocking structure for any leakage to occur. The seal has tight tolerances, and therefore, when the grooves and ribs are pressed together, leakage through the seal is not expected to occur under ambient pressure.

[0028] The formation of a fluid-impermeable barrier 106 by the first panel 108 and the second panel 110 can increase the speed of manufacturing the fluid collection assembly 100, especially when the first panel 108 and the second panel 110 are attached together using a seal 132. In some examples, the periphery of the first panel 108 and the second panel 110 may include a rectangular shape. The portion of this periphery that includes the seal 132 may include at least two sides of the rectangular shape.

[0029] In some examples, seal 132 may include an adhesive. First panel 108 and second panel 110 may include a resealable adhesive. This resealable adhesive can be more firmly attached to the second panel 110 than to the first panel 108, such that when the second panel 110 is separated from the first panel 108, the resealable adhesive is carried by the second panel 110. Resealable adhesives include those that allow two surfaces to adhere to each other and also allow these surfaces to be non-destructively separated from each other and re-adhere to each other. Examples of resealable adhesives are pressure-sensitive adhesives (PSAs), such as peelable PSAs, where adhesive bonding is achieved by applying pressure to the adhesive. The term "resealable" means that two surfaces can be re-secured to each other. When two surfaces are re-secured to each other, a degree of sealing can be achieved between them. In other words, under ambient pressure, the two surfaces can be held together by the adhesive, preventing or substantially eliminating fluid leakage.

[0030] Figure 5A and 5B This is an isometric view of the fluid collection assembly 100, wherein, according to one embodiment, the porous material 122 comprises a flexible sheet movable between an extended position and a retracted position. At least one of the first panel 108 or the second panel 110 is formed of an impermeable material that is at least partially transparent, allowing examination of the penis without removing the entire fluid collection assembly 100 from the area surrounding the penis or opening a portion of the fluid-impermeable barrier 106. For example, the chamber 112 may include at least one portion of the porous material 122 and at least a portion of the at least partially transparent material of the first panel 108 and / or the second panel 110. In other words, the porous material 122 is positioned within the chamber 112 and is generally opaque, thus forming a window through which a person can observe and examine the penis when the porous material 122 is moved. At least one porous material 122 exhibits a shape that generally corresponds to the shape of the first panel 108 and the second panel 110. As shown, the first panel 108 and the second panel 110 are rectangular, and the porous material 122 is also rectangular.

[0031] In some examples, the porous material 122 may comprise a flexible sheet having a proximal edge 136 and a distal edge 138. The proximal edge 136 may be fixed to a proximal region 116 of a fluid-impermeable barrier, and the distal edge 138 may be in an extended position (e.g., Figure 5A (as shown) and retraction position (as shown) Figure 5B The porous material 122 can move between the two (as shown). Furthermore, attaching the porous material 122 to the proximal region 116 prevents significant movement of the porous material 122 within the chamber 112, for example, preventing the porous material 122 from clumping together near the outlet 118. In one example, the porous material 122 may be attached to either the first panel 108 or the second panel 110 at the proximal region 116 (e.g., via adhesive) before or after attaching the first panel 108 to the second panel 110.

[0032] In some examples, the fluid collection assembly 100 may also include an actuator 140 attached to a distal edge 138 or at least a distal region of the porous material 122. The actuator 140 may comprise a material having sufficient stiffness to withdraw the porous material 122 and return it to an extended position. The actuator 140 may be configured to move the porous material 122 between an extended position and a retracted position. In some examples, the actuator may comprise a rod. The actuator 140 may extend through a hole 142 in the fluid-impermeable barrier 106. In some examples, the hole 142 may be located at least proximal to the proximal region 116 of the sheath 102. When the actuator 140, acting as a rod, is withdrawn, the distal edge 138 of the porous material 122 is pulled toward the proximal edge 136. Generally, the hole 142 may be located at least proximal to the proximal region 116 of the sheath 102 to minimize any fluid leakage through the hole 142. Due to the design of the fluid collection assembly 100, the fluid is configured to move toward the distal end of the assembly.

[0033] In some examples, actuator 140 may include a grip 144 that can be held by a user and / or caregiver to move actuator 140. The grip 144 may also prevent actuator 140 from passing completely through orifice 142. Orifice 142 may also include a diameter only slightly larger than the diameter of actuator 140 to minimize the possibility of leakage. When actuator 140 is withdrawn, porous material 122 may bend and / or wrinkle to expose the genitals for skin examination. Porous material 122 may include a flexible material that is resilient to damage from wrinkling.

[0034] In some examples, the fluid collection assembly 100, having a porous material 122 comprising a flexible sheet movable between an extended and retracted position, further includes a seal 132 that can be opened along the periphery of a first panel 108 and a second panel 110. The first panel 108 includes strips, and the second panel 110 includes strips capable of sealing each other with an interference fit. Thus, the user's genitals can be accessed in more than one manner. For example, an actuator 140 can be used to move the flexible sheet porous material 122 between an extended and retracted position, allowing a fluid-impermeable barrier 106 to be opened through the seal to access the area, and / or a sheath 102 to detach from the base 104 to access the area.

[0035] As discussed above, the fluid-impermeable barrier 106 defines an outlet 118, which is sized to receive the conduit 146. (Refer to previous text) Figures 3A to 3C The conduit 146 may be at least partially disposed within the chamber 112, or otherwise in fluid communication with the chamber 112 via the outlet 118. The outlet 118 may be sized and shaped to form at least substantially fluid-tight seal against the conduit 146, thereby substantially preventing bodily fluids from escaping the chamber 112 by means other than through the conduit 146. In one embodiment, the outlet 118 may be formed by the unattached portions of the first panel 108 and the second panel 110. In such an embodiment, the fluid-impermeable barrier 106 may not include a cap that exhibits greater rigidity than its surrounding portion, which may facilitate the manufacture of the fluid collection assembly 100, reduce the number of parts required to form the fluid collection assembly 100, and reduce the time required to manufacture the fluid collection assembly 100. The absence of a cap may make it difficult to secure the conduit 146 to the outlet 118 using an interference fit; however, it should be noted that attaching the conduit 146 to the outlet 118 may still be possible. Thus, conduit 146 can be attached to outlet 118 using adhesive, welding (e.g., to first and second panels 108, 110), or otherwise bonded to outlet 118. Attaching conduit 146 to outlet 118 prevents leakage and prevents conduit 146 from accidentally detaching from outlet 118. In one example, conduit 146 can be attached to outlet 118 in the same manufacturing step as attaching first and second panels 108, 110 together.

[0036] The catheter 146 may include a flexible material, such as a plastic tube (e.g., a medical tube). This plastic tube may include thermoplastic elastomers, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc. In some examples, the catheter 146 may comprise silicone or latex. In some examples, the catheter 146 may include one or more resilient portions, for example, by having one or more diameters or wall thicknesses that allow the catheter to be flexible.

[0037] The inlet 148 of the catheter 146 may be located at or near the distal region 120 of the sheath 102, which is expected to be the gravitational low point of the chamber 112 when worn by a user. Positioning the inlet 148 at or near the distal region 120 of the sheath 102 allows the catheter 146 to receive more bodily fluids compared to where the inlet 148 is located elsewhere, and reduces the likelihood of accumulation (e.g., accumulation of bodily fluids can lead to microbial growth and foul odors). For example, bodily fluids may be present in the porous material 122 due to capillary forces. However, bodily fluids may exhibit a preference for flowing in the direction of gravity, particularly when at least a portion of the porous material 122 is saturated with bodily fluids. Therefore, the inlet 148 may be positioned within the fluid collection assembly 100 at a location expected to be the gravitational low point within the fluid collection assembly 100 when worn by a user.

[0038] As discussed previously, the first panel 108, the second panel 110, and the porous material 122 can be selected to be relatively flexible. They are relatively flexible when the first panel 108, the second panel 110, and the porous material 122 cannot maintain their shape without support. The flexibility of the first panel 108, the second panel 110, and the porous material 122 allows the sheath 102 to be substantially flat. The flexibility of the first panel 108, the second panel 110, and the porous material 122 also allows the sheath 102 to conform to the shape of the penis, even when the size and shape of the penis changes (e.g., becomes erect), and minimizes any unoccupied space in the chamber 112 where bodily fluids might accumulate.

[0039] As discussed previously, the fluid collection assembly 100 includes a base 104 configured to be attached to a sheath 102. The base is configured to be attached to the sheath 102 when, for example, the fluid collection assembly 100 is configured such that the base 104 is permanently attached to the sheath 102, or the base 104 is configured not to be permanently attached to the sheath 102 but to be removably attached, so as to enable skin examination and / or replacement of the sheath 102.

[0040] As discussed previously, the base 104 is sized, shaped, and made of a material to couple to the skin surrounding the penis (e.g., mons pubis, thigh, testicle, and / or perineum) and to allow the penis to pass through it. For example, the base 104 may define an orifice 124 configured to allow the penis to pass through and be positioned therethrough. In one example, the base 104 may take on a general shape or contour of the skin surface to which it is configured to couple. The base 104 may be flexible, allowing it to conform to any shape of the skin surface and reducing tension on the skin surface. The base 104 may extend laterally beyond the sheath 102, thereby increasing the surface area of ​​the individual's skin available for attachment of the fluid collection assembly 100 compared to a substantially similar fluid collection assembly 100 without the base.

[0041] In one embodiment, the base 104 is at least partially transparent. In such an embodiment, a person (e.g., a medical practitioner) can examine the skin surrounding the penis, for example, to determine the health condition of the skin in that area surrounding the penis. Furthermore, a person can detect any gaps between the base 104 and the individual's skin through which bodily fluids may leak. Upon detecting these gaps, a person can eliminate them or replace the fluid collection assembly 100 to prevent leakage and skin deterioration due to contact with bodily fluids.

[0042] As described in more detail below, conduit 146 is configured to couple to one or more fluid storage containers (not shown) and a vacuum source (not shown), and extends at least partially between them. In one example, conduit 146 is configured to be directly connected to a vacuum source (not shown). The inlet 148 and outlet of conduit 146 are configured to fluidly couple (e.g., directly or indirectly) the vacuum source (not shown) to chamber 112. When the vacuum source ( Figure 6 When a vacuum / suction is applied in conduit 146, body fluid in chamber 112 can be drawn into inlet 148 and extracted from fluid collection assembly 100 via conduit 146. In some examples, the vacuum source may be located remotely from fluid collection assembly 100. In such examples, conduit 146 may be fluidly connected to a fluid storage container, which may be positioned between the vacuum source and fluid collection assembly 100.

[0043] During operation, a male using the fluid collection assembly 100 may drain bodily fluids (e.g., urine) into chamber 112. The bodily fluids may accumulate or be otherwise collected in chamber 112 (e.g., received into porous material 122). At least some of the bodily fluids may be drawn through the interior of conduit 146 via inlet 148. The bodily fluids may be extracted from the fluid collection assembly 100 via a vacuum / suction provided by a vacuum source.

[0044] Figure 6 This is a block diagram of a system 600 for fluid collection according to one embodiment. System 600 includes a fluid collection assembly 602, a fluid storage container 604, and a vacuum source 606. The fluid collection assembly 602, the fluid storage container 604, and the vacuum source 606 can be fluidly coupled to each other via one or more conduits 608. For example, the fluid collection assembly 602 can be operatively coupled to one or more of the fluid storage container 604 or the vacuum source 606 via conduit 608. Bodily fluids (e.g., urine or other bodily fluids) collected in the fluid collection assembly 602 can be removed from the fluid collection assembly 602 via the conduit 608, which extends into the fluid collection assembly 602. In response to a suction (e.g., vacuum) force applied at the outlet of the conduit 608, the suction force can be introduced into the chamber of the fluid collection assembly 602 via the inlet of the conduit 608.

[0045] A suction force can be applied directly or indirectly to the outlet of the conduit 608 by a vacuum source 606. The suction force can also be applied indirectly via a fluid storage container 604. For example, the outlet of the conduit 608 can be located within the fluid storage container 604, and an additional conduit 608 can extend from the fluid storage container 604 to the vacuum source 606. Therefore, the vacuum source 606 can apply suction to the fluid collection assembly 602 via the fluid storage container 604. Alternatively, the suction force can be applied directly via the vacuum source 606. For example, the outlet of the conduit 608 can be located within the vacuum source 606. An additional conduit 608 can extend from the vacuum source 606 to a point outside the fluid collection assembly 602, such as extending to the fluid storage container 604. In such an example, the vacuum source 606 can be located between the fluid collection assembly 602 and the fluid storage container 604.

[0046] The fluid collection assembly 602 may be similar to or identical to any fluid collection assembly disclosed herein in one or more aspects. For example, the fluid collection assembly 602 may include a fluid-impermeable barrier that at least partially defines a chamber of the fluid collection assembly 602. The fluid-impermeable barrier also defines an opening extending therethrough. The opening may be positioned adjacent to the penis or positioned such that the penis passes through it. The fluid collection assembly 602 may include at least one porous material disposed within the fluid-impermeable barrier. The conduit 608 includes an inlet and an outlet, the outlet being fluidly coupled to a fluid storage container, and the inlet being positioned at or near a portion of the chamber's lowest point of gravity when worn.

[0047] Fluid storage container 604 is sized and shaped to hold fluid therein. Fluid storage container 604 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection can), or any other closed container for storing bodily fluids. In some examples, a catheter 608 may extend from fluid collection assembly 602 and be attached to fluid storage container 604 at a first point therein. An additional catheter 608 may be attached to fluid storage container 604 at a second point thereon and may extend and be attached to vacuum source 606. Thus, a vacuum (e.g., aspiration) can be drawn through fluid collection assembly 602 via fluid storage container 604. Fluids such as urine can be drained from fluid collection assembly 602 using vacuum source 606.

[0048] Vacuum source 606 may include one or more of a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to generate a vacuum. Vacuum source 606 can provide a vacuum or suction to remove fluid from fluid collection assembly 602. In some examples, vacuum source 606 may be powered by one or more of a power cord (e.g., connected to a power outlet), one or more batteries, or even manual power (e.g., a manually operated vacuum pump). In some examples, vacuum source 606 may be sized and shaped to fit externally, on top of, or internally to fluid collection assembly 602. For example, vacuum source 606 may include one or more miniaturized pumps or one or more micropumps. Vacuum source 606 disclosed herein may include one or more of a switch, button, plug, remote control, or any other device suitable for activating vacuum source 606.

[0049] Figure 7 This is a flowchart of a method 700 for collecting bodily fluids from an individual using a system according to one embodiment. The method 700 for collecting fluids can utilize any fluid collection component and / or fluid collection system disclosed herein. Method 700 may include action 702, which describes “attaching a base of a fluid collection device to the skin surrounding the penis, the base being secured to or configured to be secured to a sheath, the base defining an orifice corresponding to an opening of the sheath.” Action 702 may be followed by action 704, which describes “receiving fluid discharged from the user into the fluid collection device.”

[0050] Actions 702 and 704 of method 700 are for illustrative purposes. For example, actions 702 and 704 of method 700 may be performed in a different order, divided into multiple actions, modified, supplemented, or combined. In one example, one or more of actions 702 or 704 of method 700 may be omitted from method 700. Any action 702 or 704 may include the use of any fluid collection component or system disclosed herein.

[0051] Action 702 describes “attaching the base of a fluid collection device to the skin surrounding the penis, the base being secured to or configured to be secured to a sheath.” Action 702, attaching the base of the fluid collection device to the skin surrounding the penis, may include utilizing any fluid collection assembly or system disclosed herein. In some examples, action 702 may include positioning an opening of the fluid collection assembly such that it aligns with an orifice of the base, allowing the penis to extend into a chamber of the fluid collection assembly. In some examples, action 702 may include positioning and attaching a sheath of the male fluid collection assembly to the base, such that at least a portion of the penis is positioned through an opening in the sheath and within a chamber of the fluid collection assembly.

[0052] The sheath may include a fluid-impermeable barrier comprising a proximal region and a distal region extending from the proximal region, the proximal region defining an opening and the distal region defining a fluid outlet, the fluid-impermeable barrier at least defining a chamber. The sheath may also include at least one porous material disposed within the chamber, the porous material comprising a flexible sheet having a proximal edge and a distal edge, the proximal edge being fixed to the proximal region of the fluid-impermeable barrier, and the distal edge being movable between an extended position and a retracted position.

[0053] Action 704 describes "receiving fluid discharged from the user into a fluid collection device". In some examples, receiving fluid discharged from the user includes receiving bodily fluid through an opening in the fluid collection assembly. Receiving fluid from the penis into a chamber of the fluid collection assembly may include using a porous material to wick, absorb, or adsorb the bodily fluid away from the opening. In some examples, receiving fluid discharged from the user may include receiving bodily fluid into a chamber of a sheath of the fluid collection assembly. Receiving fluid discharged from the user may include a portion of the bodily fluid flowing fluid toward an inlet of a conduit in fluid communication with a vacuum source. For example, receiving fluid discharged from the user may include allowing bodily fluid to flow, for example, via gravity, wicking, or suction, to a low point of gravity within the chamber.

[0054] Method 700 may include action 706, which states "to perform a skin examination on an individual by separating the base from the sheath." Action 706 may include temporarily separating the base of the fluid collection assembly from the sheath to examine the user's skin, and then reattaching the sheath to the base. In some examples, the sheath and the base are joined with an adhesive. In some examples, the adhesive is a resealable adhesive. In other examples, the base and the sheath are joined with an interference fit. The interference fit may include a "torsion-locking" connection.

[0055] In some examples, method 700 may include action 708, which states "to perform a skin examination on an individual by withdrawing an actuator coupled to a distal edge of a porous material." The porous material may include a distal edge and a proximal edge coupled to a proximal region of a fluid collection assembly. The porous material may include a flexible sheet, wherein the distal edge is movable between an extended position and a retracted position. The actuator may include a rod. The actuator may include a material having sufficient stiffness to withdraw the porous material and return it to the extended position. In some examples, the actuator may extend through a pore in a fluid-impermeable barrier. In some examples, the pore may be located at least proximal to the proximal region of the sheath. When the actuator is withdrawn, the distal edge of the porous material is pulled toward the proximal edge to perform a skin examination on the patient.

[0056] Method 700 may include action 710, which states "receives fluid discharged from the fluid collection device into the fluid collection container." The fluid may be configured to be discharged into the fluid collection container via a conduit connected to the fluid collection assembly. In some examples, fluid is extracted by applying suction with a vacuum source, which effectively extracts bodily fluid from a chamber via a conduit disposed therein and fluidly coupled to the vacuum source; this may include using any vacuum source disclosed herein. Applying suction with a vacuum source may include activating a vacuum source (e.g., a suction device) in fluid communication with the inlet of a conduit in the fluid collection assembly.

[0057] Method 700 may also include action 712, which states that “a vacuum is drawn using a pump via a conduit in fluid communication with the fluid outlet of the fluid collection device, effectively drawing fluid from the fluid collection device and into a fluid collection container.” In other words, in some examples, the pump applies suction that effectively draws body fluid from a chamber via a conduit disposed therein and fluidly coupled to a vacuum source, effectively removing at least some body fluid from the chamber of the fluid collection assembly. In some examples, the pump applies suction that effectively draws body fluid from the fluid collection device and transfers at least some body fluid from the device to a fluid storage container (e.g., a bottle or bag).

[0058] In some examples, a pump (e.g., a suction device) may be disposed on or inside the fluid collection assembly, and applying suction with a vacuum source may include activating the vacuum source. In some examples, the pump and / or vacuum source may be spaced apart from the fluid collection assembly, and applying suction with a vacuum source may include activating the vacuum source.

[0059] In one example, method 700 may include collecting bodily fluids removed from the fluid collection assembly, for example, by collecting them into a fluid storage container spaced apart from the fluid collection assembly and fluidly coupled to a conduit. The fluid storage container may include any fluid storage container disclosed herein.

[0060] It should be noted that the embodiments disclosed above relate to a fluid collection assembly configured to collect bodily fluids from a male. However, it should be noted that such a fluid collection assembly can also be used to collect bodily fluids from a female, since the female urethral opening is functionally similar to an implanted penis.

[0061] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are for illustrative purposes and are not intended to be limiting.

[0062] Degree terms (e.g., "about," "basically," "generally," etc.) indicate structurally or functionally insignificant changes. In one example, when a degree term is included together with a term indicating quantity, the degree term is interpreted as meaning ±10%, ±5%, or ±2% of the term indicating quantity. In one example, when a degree term is used to modify a shape, the degree term indicates that the shape modified by the degree term has the appearance of the disclosed shape. For example, the degree term can be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending from it, be elliptical, be the same as the disclosed shape, etc.

Claims

1. A fluid collection assembly, comprising: Sheath, the sheath comprising: A fluid-impermeable barrier includes a proximal region and a distal region extending from the proximal region, the proximal region defining an opening and the distal region defining a fluid outlet. The fluid-impermeable barrier at least defines a chamber. The fluid-impermeable barrier includes a first panel and a second panel, the second panel being sealed to the first panel along a periphery of the first and second panels, wherein a portion of the periphery includes a seal configured to releasably seal the periphery of the first and second panels. At least one porous material disposed in the chamber; and A base, configured to be secured to the proximal region of the sheath, configured to be attached to the skin surrounding the penis, the base defining an orifice corresponding to the opening of the sheath.

2. The fluid collection assembly according to claim 1, wherein, The opening is a first opening, and the seal includes a two-part strip defining a second opening that is sealed with an interference fit when the first panel and the second panel are pressed together, and opens when the first panel and the second panel are pulled apart.

3. The fluid collection assembly according to claim 1, wherein, The seal includes an adhesive.

4. The fluid collection assembly according to any one of claims 1 to 3, wherein, The fluid-impermeable barrier includes polyurethane or polyethylene.

5. The fluid collection assembly according to any one of claims 1 to 4, wherein, The at least one porous material exhibits a shape that generally corresponds to the shape of the first and second portions of the fluid-impermeable barrier.

6. The fluid collection assembly according to any one of claims 1 to 5, wherein, The sheath also includes a port attached to the fluid outlet, the port including a first portion defining an inlet and a second portion defining an outlet, the second portion being configured to be attached to a conduit.

7. The fluid collection assembly according to any one of claims 1 to 6, wherein, The base is releasably attached to the proximal region of the sheath.

8. The fluid collection assembly according to claim 7, wherein, The base includes a resealable adhesive between the base and the proximal region of the sheath.

9. The fluid collection assembly according to any one of claims 1 to 8, wherein, The at least one porous material includes a non-transparent fabric.

10. The fluid collection assembly according to any one of claims 1 to 9, wherein, A portion of the periphery of the first and second panels includes a partially rectangular shape, and the portion of the periphery including the seal includes at least two sides of the rectangular shape.

11. A fluid collection assembly, comprising: Sheath, the sheath comprising: A fluid-impermeable barrier comprising a proximal region and a distal region extending from the proximal region, the proximal region defining an opening and the distal region defining a fluid outlet, the fluid-impermeable barrier at least defining a chamber; and At least one porous material disposed in the chamber, the porous material comprising a flexible sheet having a proximal edge and a distal edge, the proximal edge being fixed to the proximal region of the fluid impermeable barrier, and the distal edge being movable between an extended position and a retracted position; An actuator, connected to the distal edge of the flexible sheet, configured to move the porous material between the extended position and the retracted position; and A base, which is fixed to or configured to be fixed to the proximal region of the sheath, is configured to be attached to the skin surrounding the penis, and defines an orifice corresponding to the opening of the sheath.

12. The fluid collection assembly of claim 11, wherein, The actuator includes a rod coupled to the distal edge of the flexible sheet, wherein the rod extends through a pore in the fluid-impermeable barrier, and wherein when the rod is withdrawn, the distal edge of the porous material is pulled toward the proximal edge.

13. The fluid collection assembly according to claim 11 or 12, wherein, The at least one porous material includes a non-transparent fabric.

14. The fluid collection assembly according to any one of claims 11 to 13, wherein, The at least one porous material exhibits a shape that generally corresponds to the shape of the chamber.

15. The fluid collection assembly of claim 11, wherein, The base is releasably attached to the proximal region of the sheath.

16. The fluid collection assembly of claim 11, wherein, The sheath also includes a port attached to the fluid outlet, the port including a first portion defining an inlet and a second portion defining an outlet, the second portion being configured to be attached to a conduit.

17. A method for collecting bodily fluids from an individual using a system, the method comprising: The base of a fluid collection device is attached to the skin surrounding the penis, the base being fixed to or configured to be fixed to a sheath, the base defining an orifice corresponding to an opening defined by the sheath, the sheath comprising: A fluid-impermeable barrier comprising a proximal region and a distal region extending from the proximal region, the proximal region defining the opening and the distal region defining a fluid outlet, the fluid-impermeable barrier at least defining a chamber; At least one porous material disposed in the chamber, the porous material comprising a flexible sheet having a proximal edge and a distal edge, the proximal edge being fixed to the proximal region of the fluid impermeable barrier, and the distal edge being movable between an extended position and a retracted position; The fluid discharged from the individual is received into the fluid collection device; and The fluid discharged from the fluid collection device is received into the fluid collection container.

18. The method of claim 17, further comprising performing a skin examination on the individual by separating the base from the sheath.

19. The method of claim 17, further comprising performing a skin examination on the individual by withdrawing an actuator coupled to the distal edge of the porous material, the actuator extending through a pore in the fluid-impermeable barrier, the pore being at least located proximally to the proximal region of the sheath, wherein, When the actuator is withdrawn, the distal edge of the porous material is pulled toward the proximal edge, exposing the penis of the individual.

20. The method of claim 17, further comprising using a pump to create a vacuum through a conduit in fluid communication with the fluid outlet of the fluid collection device, effectively drawing fluid from the fluid collection device and into the fluid collection container.

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