Fecal collection systems and methods

Abstract

In an example, a fecal collection system includes a user interface, an applicator, and a drainage conduit. The user interface has a proximal side and a distal side. The proximal side is configured to couple to a user. The user interface includes an aperture extending through the proximal side of the user interface and the distal side of the user interface. The applicator is coupled to the distal side of the user interface. The applicator includes an aperture extending through a proximal side of the applicator and a distal side of the applicator. The aperture of the applicator overlaps with the aperture of the user interface. The drainage conduit extends between a proximal end and a distal end. The proximal end is coupled to the distal side of the user interface. The drainage conduit defines a lumen configured to guide feces from the proximal end to the distal end.

Description

Fecal Collection Systems and MethodsCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of U.S. Provisional Application No. 63 / 718,739, filed on November 10, 2024, and U.S. Provisional Application No. 63 / 679,184, filed on August 5, 2024, the contents of which are hereby incorporated by reference in their entirety.FIELD

[0002] The present disclosure generally relates to fecal collection devices and systems for collecting feces discharged from the body of a user and carrying the feces away from the body.BACKGROUND

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

[0004] Various approaches have been developed to address some of the problems or circumstances related to impaired or restricted bowel movement processes. However, prior approaches suffer from problems or limitations of their own.SUMMARY

[0005] In an example, a fecal collection system includes a user interface, an applicator, and a drainage conduit. The user interface has a proximal side and a distal side. The proximal side is configured to couple to a user. The user interface includes an aperture extending through the proximal side of the user interface and the distal side of the user interface. The applicator is coupled to the distal side of the user interface. The applicator includes an aperture extending through a proximal side of the applicator and a distal side of the applicator. The aperture of the applicator overlaps with the aperture of the user interface. The drainage conduit extends between a proximal end and a distal end. The proximal end is coupledto the distal side of the user interface. The drainage conduit defines a lumen configured to guide feces from the proximal end to the distal end.

[0006] In another example, a fecal collection system includes a user interface and a drainage conduit. The user interface has a proximal side and a distal side. The proximal side includes a hydrogel adhesive that is configured to couple to a user. The user interface includes an aperture extending through the proximal side of the user interface and the distal side of the user interface. The drainage conduit extends between a proximal end and a distal end. The proximal end is coupled to the distal side of the user interface. The drainage conduit defines a lumen configured to guide feces from the proximal end to the distal end.

[0007] In another example, a method of using a fecal collection system includes positioning a user interface of a fecal collection system at an anus of a user. The fecal collection system includes the user interface having a proximal side and a distal side. The proximal side includes an adhesive that is configured to couple to skin of a user. The user interface includes an aperture extending through the proximal side of the user interface and the distal side of the user interface.

[0008] The fecal collection system also includes an applicator coupled to the distal side of the user interface. The applicator includes an aperture extending through a proximal side of the applicator and a distal side of the applicator. The aperture of the applicator overlaps with the aperture of the user interface. Additionally, the fecal collection system includes a drainage conduit extending between a proximal end and a distal end. The proximal end is coupled to the distal side of the user interface, and the drainage conduit defines a lumen configured to guide feces from the proximal end to the distal end.

[0009] The method can also include coupling the user interface to skin of the user by using the applicator to press the adhesive of the user interface against the skin of the user. After coupling the user interface to the skin of the user, the method can include removing the applicator from the user interface.

[0010] In another example, a method of forming a fecal collection system includes forming a user interface having a proximal side and a distal side. The proximal side includes an adhesive that is configured to couple to skin of a user. The user interface includes an aperture extending through the proximal side of the user interface and the distal side of the user interface. The method also includes coupling an applicator to the distal side of the user interface. The applicator includes an aperture extending through a proximal side of theapplicator and a distal side of the applicator. The aperture of the applicator overlaps with the aperture of the user interface. Additionally, the method includes coupling a drainage conduit to the distal side of the user interface. The drainage conduit extends between a proximal end and a distal end. The drainage conduit defines a lumen configured to guide feces from the proximal end to the distal end.

[0011] The features, functions, and advantages that have been discussed can be achieved independently in various embodiments or may be combined in yet other embodiments further details of which can be seen with reference to the following description and drawings.BRIEF DESCRIPTION OF THE FIGURES

[0012] The novel features believed characteristic of the illustrative embodiments are set forth in the appended claims. The illustrative embodiments, however, as well as a preferred mode of use, further objectives and descriptions thereof, will best be understood by reference to the following detailed description of an illustrative embodiment of the present disclosure when read in conjunction with the accompanying drawings, wherein:

[0013] Figure 1 illustrates a simplified block diagram of a fecal collection system, according to an example.

[0014] Figure 2A illustrates an exploded view of a fecal collection system, according to an example.

[0015] Figure 2B illustrates a partially assembled view of the fecal collection system shown in Figure 2A, according to the example.

[0016] Figure 3 A illustrates a proximal side of a user interface of the fecal collection system shown in Figure 2A, according to an example.

[0017] Figure 3B illustrates a distal side of the user interface shown in Figure 3 A, according to an example.

[0018] Figure 3C illustrates a perspective view of the user interface shown in Figure 3 A, according to an example.

[0019] Figure 3D illustrates an exploded view of the user interface shown in Figure 3 A, according to an example.

[0020] Figure 4A illustrates an extended state of an applicator of the fecal collection system shown in Figure 2A, according to an example.

[0021] Figure 4B illustrates a folded state of the applicator 118 shown in Figure 4A according to the example.

[0022] Figure 5A illustrates a step in a process for coupling a fecal collection system to a user, according to an example.

[0023] Figure 5B illustrates another first step in a process for coupling a fecal collection system to a user, according to an example.

[0024] Figure 5C illustrates another first step in a process for coupling a fecal collection system to a user, according to an example.

[0025] Figure 5D illustrates another first step in a process for coupling a fecal collection system to a user, according to an example.

[0026] Figure 5E illustrates another first step in a process for coupling a fecal collection system to a user, according to an example.

[0027] Figure 5F illustrates another first step in a process for coupling a fecal collection system to a user, according to an example.

[0028] Figure 5G illustrates another first step in a process for coupling a fecal collection system to a user, according to an example.

[0029] Figure 5H illustrates another first step in a process for coupling a fecal collection system to a user, according to an example.

[0030] Figure 51 illustrates another first step in a process for coupling a fecal collection system to a user, according to an example.

[0031] Figure 6A illustrates a distal side of a user interface prior to coupling the user interface to a user, according to another example.

[0032] Figure 6B illustrates the user interface of Figure 6A after coupling the user interface to the user, according to another example.

[0033] Figure 7 illustrates an implementation of a user interface, according to another example.

[0034] Figure 8 illustrates an implementation of a user interface, according to another example.

[0035] Figure 9 illustrates an implementation of a user interface, according to another example.

[0036] Figure 10A illustrates a backing formed from a polyurethane film material, according to an example.

[0037] Figure 10B illustrates a backing formed from a non-woven material, according to an example.

[0038] Figure 11 illustrates an implementation of a user interface, according to another example.

[0039] Figure 12 illustrates an implementation of a user interface, according to another example.

[0040] Figure 13 depicts an applicator 1418 as an implementation of the applicator 118 for the fecal collection system 200 shown in Figures 2A-2B and Figure 13, according to another example

[0041] Figure 14 depicts an applicator 1418 as an implementation of the applicator 118 for the fecal collection system 200 shown in Figures 2A-2B and Figure 13, according to another example.

[0042] Figure 15 depicts an implementation of a drainage conduit 112 including a funnel shape at a proximal portion, according to an example.

[0043] Figure 16 depicts a flowchart for a process of using a fecal collection system, according to an example.

[0044] Figure 17 depicts a flowchart for a process of using a fecal collection system that can be used with the process shown in at least Figure 16, according to an example.

[0045] Figure 18 depicts a flowchart for a process of using a fecal collection system that can be used with the process shown in at least Figure 16, according to an example.

[0046] Figure 19 depicts a flowchart for a process of using a fecal collection system that can be used with the process shown in at least Figure 16, according to an example.

[0047] Figure 20 depicts a flowchart for a process of using a fecal collection system that can be used with the process shown in at least Figure 19, according to an example.

[0048] Figure 21 depicts a flowchart for a process of forming a fecal collection system, according to an example.

[0049] Figure 22 depicts a flowchart for a process of forming a fecal collection system that can be used with the process shown in at least Figure 21, according to an example.

[0050] Figure 23 depicts a flowchart for a process of forming a fecal collection system that can be used with the process shown in at least Figure 22, according to an example.

[0051] Figure 24 depicts a flowchart for a process of forming a fecal collection system that can be used with the process shown in at least Figure 21, according to an example.

[0052] Figure 25 depicts a flowchart for a process of forming a fecal collection system that can be used with the process shown in at least Figure 24, according to an example.

[0053] Figure 26 depicts a flowchart for a process of forming a fecal collection system that can be used with the process shown in at least Figure 25, according to an example.

[0054] Figure 27 depicts a flowchart for a process of forming a fecal collection system that can be used with the process shown in at least Figure 25, according to an example.DETAILED DESCRIPTION

[0055] Disclosed embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all of the disclosed embodiments are shown. Indeed, several different embodiments may be described and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are described so that this disclosure will be thorough and complete and will fully convey the scope of the disclosure to those skilled in the art.

[0056] Referring to Figure 1, a simplified block diagram of a fecal collection system 100 is shown according to an example. As shown in Figure 1, the fecal collection system 100 includes a user interface 110, a drainage conduit 112, and a collection reservoir 114. The fecal collection system 100 can be coupled to the skin of the user such that the fecal collection system 100 is external to the body of the user.

[0057] The user interface 110 includes a user interface 116 and an applicator 118. The user interface 116 has a proximal side and a distal side. The proximal side is configured to couple to the skin of a user. For instance, the user interface 116 can include anadhesive 120 on the proximal side. The adhesive 120 can include a biocompatible adhesive (e.g., a silicon adhesive or a hydrogel adhesive) that can provide for coupling the user interface 116 to the skin of the user.

[0058] In some examples, the user interface 116 can include the adhesive 120 on a backing 121. For instance, the adhesive 120 can be a hydrogel adhesive on the backing 121. The hydrogel adhesive may be more advantageous than other types of adhesives (e.g., silicone adhesives) as the hydrogel adhesive can provide better adhesive performance when the skin of the user is moist while helping to maintain a microclimate that is suitable for the skin of the user. For instance, the hydrogel adhesive can (i) be hydrophilic, which can allow the hydrogel adhesive to bond well to moist skin, and / or (ii) swell when in contact with moisture, which can help the hydrogel adhesive conform to irregular contours of the skin and form a stronger and more uniform adhesive interface. The hydrogel adhesive can additionally or alternatively provide a gentle but effective adhesion, which can reduce a risk of skin irritation and damage upon removal, and / or the hydrogel adhesive can be breathable, which can allow moisture and air to pass through it and improve comfort.

[0059] In an example, the hydrogel adhesive can have a water content between approximately 20 percent and approximately 40 percent. This can provide a good balance between a rate of saturation of the hydrogel adhesive, an amount of adhesion, and user comfort. In another example, the hydrogel adhesive can have a water content of approximately 30 percent. This can provide a particularly beneficial balance of these factors.

[0060] In some examples, the hydrogel adhesive can have a thickness of approximately 0.8 millimeters to approximately 1.2 millimeters. If the hydrogel adhesive is too think, then there may not be sufficient amount of the hydrogel adhesive to take in moisture. Yet, there can be diminishing returns when the thickness of the hydrogel adhesive is increased beyond certain thicknesses. A thickness in the range of approximately 0.8 millimeters to approximately 1.2 millimeters has been found to provide suitable moisture saturation without unnecessarily increasing material use or bulk.

[0061] In some examples, the backing 121 can be a non-woven material. The combination of the backing 121 formed from the non-woven material and the adhesive 120 being a hydrogel adhesive provided an unexpected synergistic effect. In particular, it was found that the backing 121 formed from the non-woven material can help to extend a time for which the user interface 116 can be worn by the user. The reason for this is that the non-wovenmaterial is breathable, which allows for moisture to evaporate through the hydrogel adhesive and out through the non-woven material of the backing 121.

[0062] In an example, the backing 121 can have dimensions that are larger than dimensions of the hydrogel adhesive such that hydrogel adhesive is offset inwardly from a periphery of the backing 121 (e.g., around an entire circumference of the backing 121). This can help to inhibit the hydrogel adhesive from oozing beyond the outer edges of the backing 121 when applied to the user. In one example, the hydrogel adhesive can be coupled to the backing 121 by an acrylic using a cold lamination process to help achieve the offset between a periphery of the hydrogel adhesive and the periphery of the backing 121.

[0063] Although it can be particularly advantageous for the user interface 116 to have the adhesive 120 as a hydrogel adhesive that is on a non-woven material of the backing 121, the adhesive 120 and / or the backing 121 can include other types of adhesives and / or materials, respectively, in other examples. For instance, in another example, the backing 121 can be a polyurethane film material. The polyurethane film material can also have a relatively high breathability, which can allow for moisture to evaporate through the hydrogel adhesive and out of the polyurethane film material. Another benefit to polyurethane film material is that it can be transparent or translucent to improve visibility when coupling the user interface 116 to the user. Example implementations of the user interface 116 is described in further detail below with respect to Figures 3 A-3D and Figures 6A-6B.

[0064] The applicator 118 is coupled to the distal side of the user interface 116. The applicator 118 is removable from the user interface 116 while the user interface 116 is coupled to the user. In this arrangement, the applicator 118 can assist in coupling the user interface 116 to the skin of the user, and then be removed to provide for coupling the drainage conduit 112 to the user interface 116 and / or reduce an amount of material of the fecal collection system 100 between the user and a support structure (e.g., a hospital bed and / or wheel chair). Removing the applicator 118 can thus help to mitigate a risk of pressure sores. Although the applicator 118 can beneficially help to couple the user interface 116 to the skin of the user, the fecal collection system 100 can omit the applicator 118 in some implementations.

[0065] In some implementations, the applicator 118 can be directly coupled to the distal side of the user interface 116. In other implementations, the applicator 118 can be additionally or alternatively indirectly coupled to the distal side of the user interface 116. For instance, as described in further detail below, the applicator 118 can be directly coupled to thedrainage conduit 112 such that the applicator 118 engages the distal side of the user interface 116.

[0066] As examples, the applicator 118 can be formed from at least one material selected from a group consisting of: a foam, cardstock, cardboard, and chipboard (e.g., a material made from wood pulp and omitting corrugated channels of cardboard). In examples in which the applicator 118 is formed from a foam, the foam material can provide for improved conformation of the applicator 118 and the user interface 116 to the skin of the user. Cardstock can be biodegradable, which may be a benefit in examples in which the applicator 118 is formed from cardstock.

[0067] The drainage conduit 112 extends between a proximal end and a distal end. In one example, the proximal end of the drainage conduit 112 can be fixedly and permanently coupled to the distal side of the user interface 116 before the applicator 118 is removed from the user interface 116. In this example, the drainage conduit 112 is coupled to the user interface 116 while the user interface 116 is being coupled to the skin of the user. In another example, the proximal end of the drainage conduit 112 is configured to removably couple to the distal side of the user interface 116 after the applicator 118 is removed from the user interface 116. For instance, the drainage conduit 112 can be configured to couple to a port on the distal side of the user interface 116 (e.g., by a threaded connection, a hook and loop connection, a friction-fit connection, and / or an adhesive connection).

[0068] More generally, the drainage conduit 112 defines a lumen configured to guide feces from the proximal end to the distal end of the drainage conduit 112. The collection reservoir 114 can be coupled to the distal end of the drainage conduit 112. The collection reservoir 114 is configured to contain the feces. For instance, the collection reservoir 114 can be made from a liquid impermeable material. As examples, the collection reservoir 114 can be made from silicone, rubber, latex, and / or a thermoplastic.

[0069] The drainage conduit 112 and the lumen can have an elongated shape. In an example, the drainage conduit 112 can have a length of approximately 4 feet to approximately 6 feet. This length can help to position the collection reservoir 114 at a location that is remote from the user (e.g., at a side of a patient support structure such as a hospital bed). However, the drainage conduit 112 can have a different length in other examples.

[0070] In some examples, the drainage conduit 112 can have a constant diameter between the proximal end and the distal end of the drainage conduit 112. In other examples,the drainage conduit 112 can have a funnel shape at the proximal end of the drainage conduit 112. For instance, a proximal portion of the drainage conduit 112 (e.g., a portion extending proximally from the proximal end of the drainage conduit 112) can have a diameter that tapers inwardly along a distal direction. This funnel shape of the proximal portion can help to improve receiving feces into the drainage conduit 112. Figure 15 depicts an implementation of the drainage conduit 112 including a funnel shape at the proximal portion, according to one example.

[0071] Within examples, the user interface 116 can define an aperture in communication with the lumen of drainage conduit 112 (e.g., the aperture can extend through the adhesive 120 and the backing 121 and, thus, entirely through from the proximal side and the distal side of the user interface 116). In this arrangement, feces can pass from an anus of the user into the drainage conduit 112 through the aperture of the user interface 116. The drainage conduit 112 can then guide the feces to the collection reservoir 114.

[0072] Additionally, in some examples, the drainage conduit 112 can be configured to guide the feces from the proximal end to the distal end responsive to milking the drainage conduit 112 toward the collection reservoir 114 (e.g., by applying compression to the drainage conduit 112 along a length of drainage conduit 112 in a direction from the proximal end to the distal end). For instance, the drainage conduit 112 can have a hardness and / or a pliability that facilitates manually milking the feces toward the collection reservoir 114. Also, as examples, the drainage conduit 112 can be formed from a polyurethane (PU) and / or a polyvinyl chloride (PVC). For instance, the drainage conduit 112 can be a film tube having a thickness between approximately 2 mil and approximately 4 mil.

[0073] In some implementations, the drainage conduit 112 can be at least partially transparent or translucent. This can help to determine whether feces is present in the drainage conduit 112 such that a determination can be made to milk the drainage conduit 112 and force the feces to the collection reservoir 114.

[0074] In an alternative example, the fecal collection system 100 can omit the drainage conduit 112 such that the collection reservoir 114 is directly coupled to the user interface 116. Although this may reduce a cost of manufacture and reduce a need to milk the drainage conduit 112, the collection reservoir 114 is positioned nearer to the user, which increases a bulk of the device that may contact the user and makes replacing the collection reservoir 114 more challenging.

[0075] In an example, the fecal collection system 100 can also include a first one-way valve 124 in the lumen defined by the drainage conduit 112. The first one-way valve 124 is configured to allow feces to flow in a direction from the proximal end to the distal end of the drainage conduit 112 and inhibit the feces from flowing in a direction from the distal end to the proximal end of the drainage conduit 112. This can help inhibit feces from migrating back toward and into contact with the skin of the user.

[0076] In one example, the first one-way valve 124 can be configured to transition from a closed state to an open state responsive to feces passing through the first oneway valve 124 in a distal direction (e.g., from the user toward the drainage conduit 112). In the closed state, the first one-way valve 124 can inhibit backflow of feces in a proximal direction toward the user (e.g., toward the user interface 110). In the open state, the first one-way valve 124 can expand to define an enlarged passageway that allows the feces to pass through the first one-way valve 124 in a distal direction. In one implementation, the first one-way valve 124 can be configured to expand to have a diameter that is approximately equal to a diameter of the drainage conduit 112. For instance, in an implementation in which the drainage conduit 112 has a diameter of approximately 1.5 inches, the first one-way valve 124 can expand from a diameter of approximately zero inches in the closed state to a diameter of approximately 1.5 inches in the open state.

[0077] In one example implementation, the first one-way valve 124 can include a plurality of flaps that extend distally from a proximal end of the drainage conduit 112 (e.g., at the aperture of the adhesive 120). In this arrangement, the flaps can taper towards each other along a length of the flaps in a direction from the proximal end of the drainage conduit 112 toward a distal end of the drainage conduit 112. In one example, a material of the flaps can be the same as a material of the drainage conduit 112. The flaps can a monolithic structure (e.g., integral) with the drainage conduit 112 or the flaps can be distinct structures coupled to the drainage conduit 112 (e.g., via a weld).

[0078] The collection reservoir 114 can additionally or alternatively include a second one-way valve 126 that is configured to allow feces to flow from the drainage conduit 112 to the collection reservoir 114 and inhibit the feces from flowing from the collection reservoir 114 to the drainage conduit 112. This can also help inhibit feces from migrating back toward and into contact with the skin of the user. In one example, the drainage conduit 112 can have a diameter of approximately 1 inch to approximately 3 inches at the distal end.

[0079] Figures 2A-2B depict a fecal collection system 200 as an implementation of the fecal collection system 100 shown in Figure 1, according to an example. Figure 2A depicts an exploded view of the fecal collection system 200 and Figure 2B depicts a partially assembled view of the fecal collection system 200, according to the example.

[0080] As shown in Figures 2A-2B, the fecal collection system 200 includes the user interface 110, the drainage conduit 112, and the collection reservoir 114 as described above. As described above, the user interface 110 includes the user interface 116 having a proximal side 316A and a distal side 316B (shown in Figures 3A-3B). Additionally, in Figure 2A, the drainage conduit 112 extends between a proximal end 212A and a distal end 212B.

[0081] In this implementation, the drainage conduit 112 can be configured to be coupled, decoupled, and re-coupled to the collection reservoir 114. This can provide for decoupling a first collection reservoir 114 containing feces, and coupling a second collection reservoir 114 that is empty to continue collecting feces without having to decouple the user interface 116 and / or the drainage conduit 112 from the skin of the user. In some examples, the drainage conduit 112 and the collection reservoir 114 can be coupled, decoupled, and recoupled to the user interface 116 while the user interface 116 remains coupled to the skin of the user. This can provide for changing the drainage conduit 112 and / or the collection reservoir 114 without removing the user interface from 116 from the user. In other examples, the drainage conduit 112 can be permanently fixed to the collection reservoir 114. This can help to mitigate a risk of leakage at an interface between the user interface 116 and the drainage conduit 112.

[0082] In Figures 2A-2B, the distal end 212B of the drainage conduit 112 includes a male quick-connect coupler 228A that can couple to a female quick-connect coupler 228B of the collection reservoir 114. The female quick-connect coupler 228B of the collection reservoir 114 further includes an actuator 228C (e.g., a button) that is operable to couple and / or decouple the male quick-connect coupler 228A and the female quick-connect coupler 228B to each other. In this arrangement, the drainage conduit 112 can remain securely coupled to the collection reservoir 114 until the actuator 228C is operated to decouple the male quick-connect coupler 228 A of the drainage conduit 112 from the female quick-connect coupler 228B of the collection reservoir 114. This can help to inhibit (or prevent) inadvertent decoupling of the drainage conduit 112 and the collection reservoir 114. Although the drainage conduit 112 includes the male quick-connect coupler 228A and the collection reservoir 114 includes the female quick-connect coupler 228B in Figures 2A-2B, the drainage conduit 112 can includethe female quick-connect coupler 228B and the collection reservoir 114 can include the male quick-connect coupler 228A in an alternative example.

[0083] Although the distal end 212B of the drainage conduit 112 is configured to couple to the collection reservoir 114 by a quick connect coupling in Figures 2A-2B, the distal end 212B of the drainage conduit 112 can be configured to couple to the collection reservoir in a different manner in other examples (e.g., via a bayonet coupling).

[0084] In Figures 2A-2B, the proximal end 212A of the drainage conduit 112 is coupled to the distal side of the user interface 116. In this example, the drainage conduit 112 can be non-removably coupled (e.g., fixedly and permanently coupled) to the user interface 116. For instance, the proximal end 212A of the drainage conduit 112 can be welded to the distal side of the user interface 116. Additionally, the applicator 118 can include an aperture 230 that overlaps with an aperture 232 in the user interface 116 such that the drainage conduit 112 can extend through an aperture 230 in the applicator 118 to couple to the user interface 116 with the lumen of the drainage conduit 112 aligned with the aperture 232 in the user interface 116.

[0085] Figures 3 A-3D depict an implementation of the user interface 116 for the fecal collection system 200 shown in Figures 2A-2B, according to an example. In particular, Figure 3 A depicts the proximal side 316A of the user interface 116, Figure 3B depicts the distal side 316B of the user interface 116, Figure 3C depicts a perspective view of the user interface 116, and Figure 3D depicts an exploded view of the user interface 116, according to the example.

[0086] As described above, the user interface 116 has the proximal side 316A shown in Figures 3 A, 3C, and 3D, and the user interface 116 has the distal side 316B shown in Figure 3B. As shown in Figures 3A-3B, the user interface 116 can also include a first lateral side 316C, a second lateral side 316D opposite the first lateral side 316C, a sacral end 316E between the first lateral side 316C and the second lateral side 316D, and a perineal end 316F opposite the sacral end 316E. In this arrangement, the distal side 316B and the proximal side 316A of the user interface 116 extend between the first lateral side 316C, the second lateral side 316D, the sacral end 316E, and the perineal end 316F.

[0087] As shown in Figures 3A and 3C, the user interface 116 includes the adhesive 120 on the proximal side 316A of the user interface 116. In this example, the adhesive 120 includes the hydrogel adhesive. Additionally, as shown in Figure 3B, the user interfaceincludes the backing 121 on the distal side 316B of the user interface 116. For instance, the adhesive 120 can be disposed on a distal surface of the backing 121. In this example, the backing 121 includes the non-woven material and / or a polyurethane film material. As described above, this arrangement of the hydrogel adhesive and the non-woven backing and / or the polyurethane film material can help to extend a time for which the user interface 116 can be worn by the user as compared to other configurations of the user interface 116. However, the user interface 116 can be provided with a different, bio-compatible adhesive and / or a different backing in other examples.

[0088] As described above, the user interface 116 includes the aperture 232 extending through the proximal side 316A of the user interface 116 and the distal side 316B of the user interface 116. As shown in Figures 3A-3B, the aperture 232 of the user interface 116 can be in a shape of an oval. As described in further detail below, the user interface 116 can be configured to be folded about a center axis 334, which extends between the sacral end 316E and the perineal end 316F and through a center of the aperture 232, to facilitate coupling the user interface 116 to the user. The oval shape of the aperture 232 can help to obtain better coupling around an anal opening of the user, and better matches a shape of the anal opening when the buttocks of the user are pressed together as compared to a circular shape. However, the aperture 232 can have a different shape (e.g., a circle shape) in other examples.

[0089] As shown in Figures 3A-3B, a major axis 336 of the aperture 232 can be along a dimension that extends between the first lateral side 316C and the second lateral side 316D, a minor axis of the aperture 232 can be along a dimension that extends between sacral end 316E and the perineal end 316F (e.g., along the dimension that is collinear with the center axis 334 shown in Figure 3A). A size of the aperture 232 can be greater along the major axis 336 than a size of the aperture 232 along the minor axis. This can also help to obtain better coupling around an anal opening of the user, and better matches a shape of the anal opening when the buttocks of the user are pressed together.

[0090] In some examples, such as the example shown in Figures 3 A-3B, the user interface 116 can be symmetric about the center axis 334 that extends in the dimension between the sacral end 316E and the perineal end 316F, and through the center of the aperture 232. This can allow the adhesive 120 to be applied on both sides of the anal opening of the user in a more intuitive manner.

[0091] As shown in Figures 3A-3B, in some examples, the sacral end 316E of the user interface 116 can include a sacral notch 338A that extends towards the aperture 232 of the user interface 116, and / or the perineal end 316F can include a perineal notch 338B that extends towards the aperture 232 of the user interface 116. The sacral notch 338A and the perineal notch 338B can provide slack and decrease tension above and below the aperture 232 to help couple the user interface 116 to the user. For instance, omitting the adhesive 120 at the sacral notch 338 A and / or the perineal notch 338B can create a new degree of freedom and allow for greater flexibility.

[0092] In the example shown in Figures 3A-3B, the center axis 334 extends through a center of the perineal notch 338B and a center of the sacral notch 338 A. This can help to provide symmetry to the sacral notch 338A and the perineal notch 338B, which can be beneficial given the general symmetry of the anatomy of the user above and below the anal opening.

[0093] As shown in Figures 3C-3D, the user interface 116 can also include a plurality of release liners 340, 342, 344, 346, 348 that cover the adhesive 120 on the proximal side 316A of the user interface 116. The release liners 340, 342, 344, 346, 348 can be removed to expose the adhesive 120 prior to coupling the user interface 116 to the skin of the user.

[0094] In this example, the release liners 340, 342, 344, 346, 348 include a center release liner 340, a first lateral release liner 342, a second lateral release liner 344, a third lateral release liner 346, and a fourth lateral release liner 348. The center release liner 340A can be removably coupled to a center portion of the adhesive 120 extending between the sacral end 316E and the perineal end 316F. As shown in Figures 3C-3D, the center portion of the adhesive 130 can include a portion surrounding the aperture 232, a portion extending between the aperture 232 and the sacral end 316E, and a portion extending between the aperture 232 and the perineal end 316F.

[0095] In some examples, the center release liner 340A can have a length that is greater than a length of the user interface 116 between the sacral end 316E and the perineal end 316F. This can allow for a portion of the center release liner 340A to extend past the sacral end 316E and / or the perineal end 316F to allow a user to more easily grip the center release liner 340A while the center release liner 340A is coupled to the adhesive 120 of the user interface 116. Also, as shown in Figures 3C-3D, the center release liner 340A can include an aperture 341 that is aligned with the aperture 232 of the user interface 116 when the centerrelease liner 340A is removably coupled to the adhesive 120. The aperture 341 can help with aligning the aperture 232 and an anus of the user. However, as shown in Figure 12, the center release liner 340A can omit the aperture 341. This can make it more intuitive for a practioner to remove the center release liner 340A.

[0096] The first lateral release liner 342, the second lateral release liner 344, the third lateral release liner 346, and the fourth lateral release liner 348 are each removably coupled to a respective quadrant of the portion of the adhesive 120 that is not removably coupled to the center release liner 340A. In this arrangement, the release liners 340A-348 can be independently removed from the adhesive 120 to provide for coupling the user interface 116 to the user’s skin in stages, as described in further detail below. This arrangement can help to provide for a more uniform and improved coupling between the adhesive 120 and the skin of the user as compared to other arrangements (which may be implemented in other examples). This arrangement can additionally or alternatively allow the user greater flexibility in choosing which portions of the user interface 116 to couple to the user in which order based, for instance, on user preference and / or case-by-case conditions relating to a particular anatomy of a particular user.

[0097] In the example shown in Figures 3C-3D, the release liners 342-348 are arranged such that (i) the first lateral release liner 342 can be removably coupled to a first portion of the adhesive 120 that is between the center axis 334, a transverse axis 350 (which is perpendicular to the center axis 334 and extends through the center of the aperture 232), the first lateral side 316C, and the sacral end 316E, (ii) the second lateral release liner 344 can be removably coupled to a second portion of the adhesive 120 that is between the center axis 334, the transverse axis 350, the second lateral side 316D, and the sacral end 316E, (iii) the third lateral release liner 346 can be removably coupled to a third portion that is between the center axis 334, the transverse axis 350, the first lateral side 316C, and the perineal end 316F, and (iv) the fourth lateral release liner 348 can be removably coupled to a fourth portion that is between the center axis 334, the transverse axis 350, the second lateral side 316D, and the perineal end 316F.

[0098] The first lateral release liner 342 can include a first portion 342A and a second portion 342B. The first portion 342A of the first lateral release liner 342 can cover the first portion of the adhesive 120 to inhibit the adhesive 120 prematurely or inadvertently adhering to an object prior to application of the user interface 116 to the user. The second portion 342B of the first lateral release liner 342 can have a first end that is coupled to the firstportion 342A at an inner portion of the user interface 116 (e.g., at or near the transverse axis 350), and a second end that is separate from the first portion 342A at an outer portion of the user interface 116 (e.g., at the peripheral edge of the user interface 116). In this arrangement, a practitioner can grasp the second end at the periphery of the user interface 116 and pull outwardly away from the user to separate the first portion 342A of the first lateral release liner 342 from the adhesive 120. In this way, the first lateral release liner 342 can be progressively expose the first portion of the adhesive 120 in a direction from the aperture 232 towards the peripheral edge of the user interface 116. This can help to improve coupling the adhesive 120 to the buttocks of the user with the aperture 232 aligned with the anus of the user.

[0099] The second lateral release liner 344 can include a first portion 344A and a second portion 344B. The first portion 344A of the second lateral release liner 344 can cover the second portion of the adhesive 120 to inhibit the adhesive 120 prematurely or inadvertently adhering to an object prior to application of the user interface 116 to the user. The second portion 344B of the second lateral release liner 344 can have a first end that is coupled to the first portion 344A at an inner portion of the user interface 116 (e.g., at or near the transverse axis 350), and a second end that is separate from the first portion 344A at an outer portion of the user interface 116 (e.g., at the peripheral edge of the user interface 116). In this arrangement, a practitioner can grasp the second end at the periphery of the user interface 116 and pull outwardly away from the user to separate the first portion 344A of the second lateral release liner 344 from the adhesive 120. In this way, the second lateral release liner 344 can be progressively expose the second portion of the adhesive 120 in a direction from the aperture 232 towards the peripheral edge of the user interface 116. This can help to improve coupling the adhesive 120 to the buttocks of the user with the aperture 232 aligned with the anus of the user.

[0100] The third lateral release liner 346 can include a first portion 346A and a second portion 346B. The first portion 346A of the third lateral release liner 346 can cover the third portion of the adhesive 120 to inhibit the adhesive 120 prematurely or inadvertently adhering to an object prior to application of the user interface 116 to the user. The second portion 346B of the third lateral release liner 346 can have a first end that is coupled to the first portion 346A at an inner portion of the user interface 116 (e.g., at or near the transverse axis 350), and a second end that is separate from the first portion 346A at an outer portion of the user interface 116 (e.g., at the peripheral edge of the user interface 116). In this arrangement, a practitioner can grasp the second end at the periphery of the user interface 116 and pulloutwardly away from the user to separate the first portion 346A of the third lateral release liner 346 from the adhesive 120. In this way, the third lateral release liner 346 can be progressively expose the third portion of the adhesive 120 in a direction from the aperture 232 towards the peripheral edge of the user interface 116. This can help to improve coupling the adhesive 120 to the buttocks of the user with the aperture 232 aligned with the anus of the user.

[0101] The fourth lateral release liner 348 can include a first portion 348 A and a second portion 348B. The first portion 348A of the fourth lateral release liner 348 can cover the fourth portion of the adhesive 120 to inhibit the adhesive 120 prematurely or inadvertently adhering to an object prior to application of the user interface 116 to the user. The second portion 348B of the fourth lateral release liner 348 can have a first end that is coupled to the first portion 348 A at an inner portion of the user interface 116 (e.g., at or near the transverse axis 350), and a second end that is separate from the first portion 348 A at an outer portion of the user interface 116 (e.g., at the peripheral edge of the user interface 116). In this arrangement, a practitioner can grasp the second end at the periphery of the user interface 116 and pull outwardly away from the user to separate the first portion 348A of the fourth lateral release liner 348 from the adhesive 120. In this way, the fourth lateral release liner 348 can be progressively expose the third portion of the adhesive 120 in a direction from the aperture 232 towards the peripheral edge of the user interface 116. This can help to improve coupling the adhesive 120 to the buttocks of the user with the aperture 232 aligned with the anus of the user.

[0102] In use, the center release liner 340 can be removed from the adhesive 120 first. This can expose a central portion of the adhesive 120 around the aperture 232, which can allow a seal to be first formed around the anal opening. After the central portion of the adhesive 120 is coupled to the skin of the user between the buttocks, then the first lateral release liner 342, the second lateral release liner 344, the third lateral release liner 346, and the fourth lateral release liner 348 can be independently removed from the adhesive 120 and the respective first portion, second portion, third portion, and fourth portion of the adhesive 120 can be coupled to the user. Removing the center release liner 340 and coupling the central portion of the adhesive 120 to the skin of the user first can help to apply the adhesive 120 to the skin of the user with fewer wrinkles than other approaches.

[0103] Figures 4A-4B depict an implementation of the applicator 118 for the fecal collection system 200 shown in Figures 2A-2B, according to an example. In particular, Figure 4A depicts the applicator 118 in an extended state and Figure 4B depicts the applicator 118 in a folded state, according to the example.

[0104] As described above, the applicator 118 is configured to be coupled to the distal side 316B of the user interface 116 and / or the drainage conduit 112, and is removable from the user interface 116 and / or the drainage conduit 112 while the user interface 116 is coupled to the user. In this arrangement, the applicator 118 can assist in coupling the user interface 116 to the skin of the user, and then be removed to provide for coupling the drainage conduit 112 to the user interface 116 and / or reduce an amount of material of the fecal collection system 100 between the user and a support structure (e.g., a hospital bed and / or wheel chair). Removing the applicator 118 can thus help to mitigate a risk of pressure sores.

[0105] As shown in Figure 4A, the applicator 118 includes an aperture 456 that extends through a proximal side of the applicator 118 and a distal side of the applicator 118. When fecal collection system 100 is assembled, the aperture 456 of the applicator 118 overlaps with the aperture 232 of the user interface 116, and the drainage conduit 112 extends through the aperture 456 of the applicator 118.

[0106] As shown in Figure 4A, the aperture 452 of the applicator 118 can be in a shape of an oval. The oval shape of the aperture 452 can help to obtain better coupling around an anal opening of the user, and better matches a shape of the anal opening when the buttocks of the user are pressed together as compared to a circular shape. However, the aperture 452 can have a different shape (e.g., a circle shape) in other examples.

[0107] Within examples, when the applicator 118 is in the extended state shown in Figure 4A, the applicator 118 can be more easily removed the applicator 118 from the user interface 116. For instance, in some examples, the applicator 118 can be configured to be tom through the aperture 456 to facilitate removing the applicator 118 from the drainage conduit 112 and / or the user interface 116.

[0108] When the applicator 118 is in the folded state shown in Figure 4B, the applicator 118 can help to insert the applicator 118 and the user interface 116 between buttocks to access an anus of a user. As shown in Figures 4A-4B, the applicator 118 can include a plurality of fold lines 454A-454D that are configured to form a contact surface of the applicator 118, which has a geometry that can help to improve coupling the user interface 116 to the user.

[0109] As shown in Figure 4A, the applicator 118 includes a superior side 456A, an inferior side 456B, a first lateral side 456C extending between the superior side 456A and the inferior side 456B, and a second lateral side 456D extending between the superior side 456A and the inferior side 456B. In general, the superior side 456A is configured to bepositioned superior to the anus of the user when the applicator 118 is used to couple the user interface 116 to the user, the inferior side 456B is configured to be positioned inferior to the anus of the user when the applicator is used to couple the user interface 116 to the user. The proximal side of the applicator 118 and the distal side of the applicator 118 each extend on opposing sides between the superior side 456A, the inferior side 456B, the first lateral side 456C, and the second lateral side 456D.

[0110] The applicator 118 includes a central portion 458A extending between the superior side 456A of the applicator 118 and an inferior side 456B of the applicator 118, a first lateral portion 458B on a first lateral side of the central portion 458 A, and a second lateral portion 458C on a second lateral side of the central portion 458 A. The central portion 458 A includes the aperture 452 of the applicator 118. As shown in Figures 4A-4B, the applicator 118 also includes the fold lines 454A-454D about which the first lateral portion 458B and the second lateral portion 458C are configured to fold relative to the central portion 458 A.

[0111] At least some of the fold lines 454A-454D can thus define boundaries between the central portion 458 A and the first lateral portion 458B, and the central portion 458A and the second lateral portion 458C. For example, a first fold line 454A is between the central portion 458A and the first lateral portion 458B, and a second fold line 454B is between the central portion 458A and the second lateral portion 458C.

[0112] In this arrangement, the first lateral portion 458B and the second lateral portion 458C are configured to move about the first subset of the first fold line 454A and the second fold line 454B, respectively, to actuate the applicator 118 between the extended state and the folded state. When the applicator 118 is in the folded state, the distal side of the applicator 118 at the first lateral portion 458B faces the distal side of the applicator 118 at the second lateral portion 458C, and the proximal side of the applicator 118 at the central portion 458 A defines one or more outwardly facing surfaces extending between the first fold line 454 A, the second fold line 454B, the superior side 456A, and the inferior side 456B.

[0113] As shown in Figure 4A, along a width extending between the first lateral side 456C of the of the applicator 118 and a second lateral side 456D of the applicator 118, the first fold line 454A and the second fold line 454B are separated by a non-zero distance from each other. As a result, the central portion 458A has a width that is greater than a width of the applicator 118 if the applicator 118 was instead folded about a center axis 460 of the applicator 118.. In this arrangement, the central portion 458A can provide a greater surface area and / orimproved geometry (e.g., three-dimensional surface contours) to more accurately press the adhesive 120 of the user interface 116 against the skin around the anus of the user as compared to the alternative implementations in which the applicator 118 includes a single fold line for folding the applicator 118 in half. This can help to ultimately form a better seal between the user interface 116 and the drainage conduit 112 around the anus of the user, which can help to mitigate leakage.

[0114] In the example shown in Figures 4A-4B, the first fold line 454A and the second fold line 454B can be spaced laterally from the aperture 452. This can help to position the aperture 452 in the central portion 458A when the applicator 118 is in the folded state. As a result, the central portion 458 A can provide surfaces above and below the aperture 452, whereas the first lateral portion 458B and the second lateral portion 458C can provide surfaces that can extend away from the buttocks for gripping and handling the applicator 118.

[0115] In the example shown in Figure 4A, the first fold line 454A includes a first axial segment 462A, a first bump-out segment 462B, and a second axial segment 462C. The first bump-out segment 462B can be between the first axial segment 462A and the second axial segment 462C. The first bump-out segment 462B can extend from the first axial segment 462A and the second axial segment 462C toward the first lateral side 456C of the applicator 118. Similarly, the second fold line 454B includes a first axial segment 464A, a second bumpout segment 464B, and a second axial segment 464C. The second bump-out segment 464B can be between the first axial segment 464A and the second axial segment 464C. The second bump-out segment 464B can extend from the first axial segment 464A and the second axial segment 464C toward the second lateral side 456D of the applicator 118.

[0116] As shown in Figure 4B, in this arrangement, the first fold line 454A and the second fold line 454B can provide the central portion 458 A with a first lateral protrusion 466A and a second lateral protrusion 466B when the applicator 118 is in the folded state. The first lateral protrusion 466A and the second lateral protrusion 466B can help press the adhesive 120 surrounding the drainage conduit 112 to the skin of the user surrounding the anus and, in particular, press the adhesive 120 against a “crack” area of the user to help form the seal around the anus. For instance, the first lateral protrusion 466A and the second lateral protrusion 466B can be on opposing sides of the aperture 452 (e.g., the center portion 458A can have a cross shape with the aperture 452 disposed at an intersection between the center axis 460 and an axis extending through the first lateral protrusion 466A and the second lateral protrusion 466B).

[0117] As shown in Figure 4A, the fold lines 454A-454D can also include a third fold line 454C and a fourth fold line 454D. The third fold line 454C can be above the aperture 452 and along the center axis 460, and the fourth fold line 454D can be below the aperture 452 and along the center axis 460. The third fold line 454C and the fourth fold line 454D can allow the applicator 118 to fold along the center axis 460. This can allow for closer application of the user interface 116 to the anatomy of the user than other implementations that omit the third fold line 454C and the fourth fold line 454D. Nevertheless, the applicator 118 can omit the third fold line 454C and the fourth fold line 454D in other examples.

[0118] Additionally, in the example shown in Figure 4A, the center axis 460 of the applicator 118 (i) extends in a dimension between the superior side 456A and the inferior side 456B and (ii) through the aperture 754 of the applicator 118. In Figures 4A-4B, the central portion 458A of the applicator 118 can be symmetric about the center axis 460.

[0119] In the example shown in Figures 4A-4B, the fold lines 454A-454D can be complete cuts through the thickness of the applicator 118. In other examples, one or more of the fold lines 454A-454D can be score lines formed by a scoring machine having an edge that runs alone the applicator to create a groove or crease along the fold lines 454A-454D. In other examples, the fold lines 454A-454D additionally or alternatively can be formed by respective partial cuts that extend partially through a thickness of the applicator 118, where the thickness of the applicator 118 extends in a dimension between the proximal side and the distal side of the applicator 118. For instance, in one implementation, the respective partial cuts can each extend through approximately 75 percent of the thickness of the applicator 118. This can provide a good a balance between foldability and durability of the applicator 118.

[0120] Additionally, the fold lines 454A-454D can be configured to facilitate removing the applicator 118 from the user interface 116 (e.g., by making it easier to tear the applicator 118 between the aperture 452 and the superior side 456A and / or the inferior side 456B).

[0121] In some examples, the first lateral portion 458B and the second lateral portion 458C can be configured to couple to each other to maintain the applicator 118 in the folded state. For instance, as shown in Figure 4A, the applicator 118 can additionally or alternatively include a first slot 468 A at the first lateral portion 458B, and a second slot 468B at the second lateral portion 458C. The first slot 468A and the second slot 468B are configured to couple to each other to maintain the applicator 118 in the folded state (e.g., without anexternal force being applied to the first lateral portion 458B and the second lateral portion 458C). In this example, the first slot 468A extends from a periphery of the applicator 118 in a direction towards the inferior side 456B, and the second slot 468B extends from the periphery of the applicator 118 in a direction towards the superior side 456A.

[0122] When the first lateral portion 458B is coupled to the second lateral portion 458C by the first slot 468 A mated with the second slot 468B, the first lateral portion 458B and the second lateral portion 458C can provide a handle that is easier to grip and use than when the user must manually apply a force to maintain the first lateral portion 458B and the second lateral portion 458C in the folded state.

[0123] Referring nowto Figures 5A-5E, process for coupling the fecal collection system 100 of Figures 2A-4B to a user is depicted according to one example implementation of the user interface 110. In Figure 5A, the user interface 110 includes the applicator 118 coupled to the user interface 116 and the drainage conduit 112. The drainage conduit 112 extends through the aperture 452 of the applicator 118. Also, in Figure 5 A, the applicator 118 is in the folded state with the first lateral portion 458B coupled to the second lateral portion 458C as shown in Figure 4B. Additionally, in Figure 5A, the center release liner 340 has been removed from the adhesive 120 to expose the portion of the adhesive 120 underlying the center release liner 340 (e.g., a portion of the adhesive 120 that overlaps with the central portion 458A of the applicator 118).

[0124] In Figure 5B, the user interface 110 is inserted between the buttocks of the user. For instance, with the applicator 118 in the folded state, a medical practitioner can hold the first lateral portion 458B and the second lateral portion 458C of the applicator 118 and press the exposed portion of the adhesive 120 surrounding the aperture 232 to the area of the skin of the user surrounding the anus. As shown in Figure 5B, this allows the medical practitioner to hold the user interface 110 at a location remote from the buttocks while positioning the aperture 232 in the user interface 116 and the drainage conduit 112 at the anus.

[0125] In Figure 5B, the first lateral release liner 342 is removed from the first portion of the adhesive 120. For example, the medical practioner can grasp the second portion 342B of the first lateral release liner 342 at the periphery of the user interface 116 and pull outwardly away from the user to separate the first portion 342A of the first lateral release liner 342 from the adhesive 120. In this way, the first lateral release liner 342 can be progressively expose the first portion the adhesive 120 in a direction from the aperture 232 (and the transverseaxis 350 shown in Figure 3C) towards the peripheral edge of the user interface 116. Figure 5C depicts the first portion of the adhesive 120 coupled to the skin of the user after the first lateral release liner 342 has been completely removed from the adhesive 120.

[0126] In Figure 5D, the second lateral release liner 344 is removed from the second portion of the adhesive 120. For example, the medical practioner can grasp the second portion 344B of the second lateral release liner 344 at the periphery of the user interface 116 and pull outwardly away from the user to separate the first portion 344A of the second lateral release liner 344 from the adhesive 120. In this way, the second lateral release liner 344 can be progressively expose the second portion the adhesive 120 in a direction from the aperture 232 (and the transverse axis 350 shown in Figure 3C) towards the peripheral edge of the user interface 116.

[0127] In Figure 5E, the third lateral release liner 346 is removed from the third portion of the adhesive 120. For example, the medical practioner can grasp the second portion 346B of the third lateral release liner 346 at the periphery of the user interface 116 and pull outwardly away from the user to separate the first portion 346A of the third lateral release liner 346 from the adhesive 120. In this way, the third lateral release liner 346 can be progressively expose the third portion the adhesive 120 in a direction from the aperture 232 (and the transverse axis 350 shown in Figure 3C) towards the peripheral edge of the user interface 116.

[0128] In Figure 5F, the fourth lateral release liner 348 is removed from the fourth portion of the adhesive 120. For example, the medical practioner can grasp the second portion 348B of the fourth lateral release liner 348 at the periphery of the user interface 116 and pull outwardly away from the user to separate the first portion 348A of the fourth lateral release liner 348 from the adhesive 120. In this way, the fourth lateral release liner 348 can be progressively expose the fourth portion the adhesive 120 in a direction from the aperture 232 (and the transverse axis 350 shown in Figure 3C) towards the peripheral edge of the user interface 116.

[0129] Figure 5G depicts the user interface 116 coupled to the user after the applicator 118 is removed from the user interface 116 and the drainage conduit 112. Figures 5H-5I depicts the distal end 212B of the drainage conduit 112 being coupled to the collection reservoir 114. As shown in Figures 5H-5I, the collection reservoir 114 can be coupled to the side of a patient support structure (e.g., a hospital bed).

[0130] In other examples, the first lateral release liner 342, the second lateral release liner 344, the third lateral release liner 346, and / or the fourth lateral release liner 348 can be removed from the adhesive 120, and the respective portions of the adhesive 120 can be coupled to the skin of the user in a different order than the order depicted in Figures 5B-5F.

[0131] Referring now to Figures 6A-6B, a user interface 616 as another implementation of the user interface 116 described above is shown, according to another example. Figure 6A depicts the distal side 316B of the user interface 616 prior to coupling the user interface 616 to a user, and Figure 6B depicts the user interface 616 after coupling the user interface 616 to the user.

[0132] The user interface 616 is substantially similar or identical to the user interface 116 described above with respect to Figures 1-51, except the user interface 616 shown in Figures 6A-6B also includes a perineal wedge 670 on the distal side 316B of the user interface 616. The perineal wedge 670 can be a V-shaped piece of flexible material that is disposed between the aperture 232 and the perineal end 316F. Accordingly, the perineal wedge 670 can include a first wedge leg 670A, a second wedge leg 670B, and a vertex 670C between the first wedge leg 670A and the second wedge leg 670B. The vertex 670C can be at the center axis 334 of the user interface 116. The first wedge leg 670A can extend (i) distally from the vertex 670C and (ii) from the vertex 670C towards the first lateral side 316C of the user interface 116. The second wedge leg 670B can extend (i) distally from the vertex 670C and (ii) from the vertex 670C towards the second lateral side 316D of the user interface 116.

[0133] In some instances, a moist environment of the perineum of the user can make it difficult for the adhesive 120 to adhere to the skin of the user at the perineum. That in turn can inhibit forming a sufficient seal around the entire anal opening. The perineal wedge 670 can reinforce the user interface 116 at the perineum and help to improve the seal around the anal opening. The first wedge leg 670A and the second wedge leg 670B can be compressed together by a force of the buttocks and create a pressure at the vertex 670C (e.g., at the perineum).

[0134] As one example, the perineal wedge 670 can be formed from a silicone material. However, the perineal wedge 670 can be formed from other materials in other examples.

[0135] In some implementations, the perineal wedge 670 can be coupled to the backing 121 of the user interface 116 prior to coupling the user interface 116 to the user (e.g.,at a time of manufacture). In other implementations, the perineal wedge 670 an be coupled to the backing 121 of the user interface after coupling the user interface 116 to the user.

[0136] Referring now to Figures 7-9, a user interface 716, 816, 916 as further implementations of the user interface 116 described above is shown, according to additional examples. In Figures 7-9, the backing 121 is formed from the polyurethane film material. In Figure 7, the user interface 716 is substantially similar or identical to the user interface shown in Figures 3A-3D. As such, the aperture 232 of the user interface 116 is an oval with the major axis 336 extending along a dimension between the first lateral side 316C and the second lateral side 316D, and the minor axis extending along a dimension between sacral end 316E and the perineal end 316F. In Figure 8, the user interface 816 is substantially similar or identical to the user interface shown in Figure 7, except the aperture 232 is an oval with the minor axis extending along a dimension between the first lateral side 316C and the second lateral side 316D, and the major axis 336 extending along a dimension between sacral end 316E and the perineal end 316F. In Figure 9, the user interface 816 is substantially similar or identical to the user interface shown in Figure 7, except the aperture 232 is a circle.

[0137] Figure 10A depicts the backing 121 formed from a polyurethane film material, and Figure 10B depicts the backing 121 formed from a non-woven material.

[0138] Figure 11 depicts a user interface 1116 as another implementation of the user interface 116 described above. The user interface 116 is substantially similar or identical to the user interfaces 116, 616, 716, 816, 916 described above, except the user interface 1116 also includes a weld ring 1172 around the aperture 232. The weld ring 1172 can be formed by applying pressure to the adhesive 120 (and the backing 121) to compress the adhesive 120 at the weld ring 1172. As a result, the adhesive 120 can have a thinner profile at the weld ring 1172, which can act as a barrier to help reduce saturation of an outer portion 1120A of the adhesive 120 when liquids flow through the aperture 232 and contacts an inner portion 1120B of the adhesive 120. As shown in Figure 11, the weld ring 1172 can separate the outer portion 1120 A of the adhesive 120 from the inner portion 1120B of the adhesive 120, functioning as a dam and / or a trench that helps to inhibit excessive saturation of the outer portion 1120A which may otherwise compromise the adhesive performance of the outer portion 1120A.

[0139] In some examples, the weld ring 1172 can be formed by applying pressure to the adhesive 120 to compress the adhesive 120 at the weld ring 1172 while coupling the proximal end of the drainage conduit 112 to the distal side of the user interface 116. Forinstance, in one example, the proximal end of the drainage conduit 112 can be coupled to the distal side of the user interface 116 by an impulse weld. While applying the impulse weld, between the drainage conduit 112 and the user interface 116, the impulse welding can apply a pressure through the drainage conduit 112 and the backing 121 of the user interface 116 to compress the adhesive 120 at the weld ring 1172. In some implementations, the drainage conduit 112 can be folded over on itself at a fold line, which defines the proximal end (e.g., by approximately 0.75 inches), and the impulse weld can be applied at the fold line. This can help to facilitate simultaneously forming the proximal end of the drainage conduit 112 and the weld ring 1172.

[0140] Figure 13 depicts an applicator 1318 as an implementation of the applicator 118 for the fecal collection system 200 shown in Figures 2A-2B, according to another example. The applicator 1318 shown in Figure 13 is substantially similar to the applicator 118 shown in Figure 4A, except (i)the applicator 1318 omits the first slot 468 A and the second slot 468B, (ii) the aperture 452 is an oval having a major axis along the center axis 460, and (99) the applicator 1318 includes a notch 1374 at the superior side 4456A and the inferior side 456B. The notch 1374 is configured to make it easier to start tearing the applicator 1318 along the center axis 460.

[0141] Figure 14 depicts an applicator 1418 as an implementation of the applicator 118 for the fecal collection system 200 shown in Figures 2A-2B and Figure 13, according to another example. The applicator 118 shown in Figure 14 is substantially similar to the applicator 118 shown in Figure 13, except (i) the fold lines 454A-454D can be perforation lines and (ii) the notch 1374 can have elongated tabs. The elongated tabs of the notch 1374 can provide a more intuitive visual cue to an operator to help start tearing the applicator 1318 along the center axis 460.

[0142] Referring now to Figure 16, a process 1600 for using a fecal collection system is shown, according to an example. At block 1610, the process 1600 includes positioning a user interface of a fecal collection system at an anus of a user. The fecal collection system includes the user interface having a proximal side and a distal side. The proximal side includes an adhesive that is configured to couple to skin of a user. The user interface includes an aperture extending through the proximal side of the user interface and the distal side of the user interface.

[0143] The fecal collection system also includes an applicator coupled to the distal side of the user interface. The applicator includes an aperture extending through a proximal side of the applicator and a distal side of the applicator. The aperture of the applicator overlaps with the aperture of the user interface. Additionally, the fecal collection system includes a drainage conduit extending between a proximal end and a distal end. The proximal end is coupled to the distal side of the user interface, and the drainage conduit defines a lumen configured to guide feces from the proximal end to the distal end.

[0144] At block 1612, the process 1600 includes coupling the user interface to skin of the user by using the applicator to press the adhesive of the user interface against the skin of the user. At block 1614, the process 1600 includes, after coupling the user interface to the skin of the user at block 1612, removing the applicator from the user interface.

[0145] Figures 17-20 depict additional aspects of the process 1600 according to further examples. As shown in Figure 17, coupling the user interface to skin of the user at block 1612 can include adhering the user interface to the skin of the user by the adhesive at block 1616, and the adhesive can be a hydrogel adhesive.

[0146] In Figure 18, the user interface comprises a weld ring around the aperture of the user interface, and the weld ring can separate an outer portion of the adhesive from an inner portion of the adhesive. As shown in Figure 18, the process 1600 can include providing by the weld ring a barrier that inhibits saturation of the outer portion of the adhesive at block 1618.

[0147] As shown in Figure 19, the process 1600 can also include removing a plurality of release liners that cover the adhesive on the proximal side of the user interface to expose the adhesive at block 1620.

[0148] In Figure 20, the plurality of release liners can include a center release liner, a first lateral release liner, a second lateral release liner, a third lateral release liner, and a fourth lateral release liner. The center release liner is removably coupled to a center portion of the adhesive extending between a sacral end and a perineal end. The center portion of the adhesive includes a portion surrounding the aperture of the user interface, a portion extending between the aperture and the sacral end, and a portion extending between the aperture and the perineal end. The first lateral release liner, the second lateral release liner, the third lateral release liner, and the fourth lateral release liner are each removably coupled to a respective quadrant of a portion of the adhesive that is not removably coupled to the center release liner.

[0149] As shown in Figure 20, removing the plurality of release liners at block 1620 and coupling the user interface to the skin of the user at block 1612 can include: (A) removing the center release liner to expose a central portion of the adhesive around the aperture of the user interface at block 1622, (B) after removing the center release liner at block 1622, coupling the central portion of the adhesive to the skin of the user at block 1624, and (C) after coupling the central portion of the adhesive to the skin of the user at block 1624, performing the following at block 1626: (i) removing the first lateral release liner from a first portion of the adhesive and coupling the first portion of the adhesive to the skin of the user, (ii) removing the second lateral release liner from a second portion of the adhesive and coupling the second portion of the adhesive to the skin of the user, (iii) removing the third lateral release liner from a third portion of the adhesive and coupling the third portion of the adhesive to the skin of the user, and (iv) removing the fourth lateral release liner from a fourth portion of the adhesive and coupling the fourth portion of the adhesive to the skin of the user.

[0150] Referring now to Figure 21, a process 2100 for using a fecal collection system is shown, according to an example. As shown in Figure 21, at block 2110, the process 2100 can include forming a user interface having a proximal side and a distal side. The proximal side includes an adhesive that is configured to couple to skin of a user. The user interface includes an aperture extending through the proximal side of the user interface and the distal side of the user interface.

[0151] At block 2112, the process 2100 includes coupling an applicator to the distal side of the user interface. The applicator includes an aperture extending through a proximal side of the applicator and a distal side of the applicator, and the aperture of the applicator overlaps with the aperture of the user interface. At block 2114, the process 2100 includes coupling a drainage conduit to the distal side of the user interface. The drainage conduit extends between a proximal end and a distal end, and the drainage conduit defines a lumen configured to guide feces from the proximal end to the distal end.

[0152] Figures 22-27 depict additional aspects of the process 2100 according to further examples. As shown in Figure 22, the process 2100 can also include forming the user interface by coupling the adhesive to a backing at block 2116.

[0153] As shown in Figure 23, coupling the adhesive to the backing at block 2116 can include coupling the adhesive to the backing by an acrylic using a cold lamination process to achieve an offset between a periphery of the hydrogel adhesive and a periphery ofthe backing at block 2118. The backing has dimensions that are larger than dimensions of the adhesive such that adhesive is offset inwardly from the periphery of the backing.

[0154] As shown in Figure 24, the process 2100 can also include forming a weld ring on the adhesive such that the weld ring provides a barrier separating an outer portion of the adhesive from an inner portion of the adhesive at block 2120.

[0155] As shown in Figure 25, forming the weld ring at block 2120 can include applying pressure to the adhesive to compress the adhesive at the weld ring while coupling the proximal end of the drainage conduit to the distal side of the user interface at block 2122.

[0156] As shown in Figure 26, coupling the proximal end of the drainage conduit to the distal side of the user interface at block 2122 can include applying an impulse weld to the drainage conduit and the user interface at the weld ring at block 2124.

[0157] As shown in Figure 27, coupling the proximal end of the drainage conduit to the distal side of the user interface at block 2122 can include folding a portion of the drainage conduit over on itself at a fold line and applying the impulse weld at the fold line at block 2126.

[0158] The description of the different advantageous arrangements has been presented for purposes of illustration and description, and is not intended to be exhaustive or limited to the embodiments in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art. Further, different advantageous embodiments may describe different advantages as compared to other advantageous embodiments. The embodiment or embodiments selected are chosen and described in order to explain the principles of the embodiments, the practical application, and to enable others of ordinary skill in the art to understand the disclosure for various embodiments with various modifications as are suited to the particular use contemplated.

Claims

CLAIMSWhat is claimed is:

1. A fecal collection system, comprising: a user interface having a proximal side and a distal side, wherein the proximal side comprises an adhesive that is configured to couple to skin of a user, wherein the adhesive is a hydrogel adhesive, wherein the user interface comprises an aperture extending through the proximal side of the user interface and the distal side of the user interface; and a drainage conduit extending between a proximal end and a distal end, wherein the proximal end is coupled to the distal side of the user interface, wherein the drainage conduit defines a lumen configured to guide feces from the proximal end to the distal end.

2. A fecal collection system, comprising: a user interface having a proximal side and a distal side, wherein the proximal side comprises an adhesive that is configured to couple to skin of a user, wherein the user interface comprises an aperture extending through the proximal side of the user interface and the distal side of the user interface; an applicator coupled to the distal side of the user interface, wherein the applicator comprises an aperture extending through a proximal side of the applicator and a distal side of the applicator, wherein the aperture of the applicator overlaps with the aperture of the user interface; and a drainage conduit extending between a proximal end and a distal end, wherein the proximal end is coupled to the distal side of the user interface, wherein the drainage conduit defines a lumen configured to guide feces from the proximal end to the distal end.

3. The fecal collection system of claim 2, wherein the applicator comprises: a central portion extending between a superior side of the applicator and an inferior side of the applicator, wherein the central portion includes the aperture of the applicator; a first lateral portion on a first lateral side of the central portion; a second lateral portion on a second lateral side of the central portion; a first fold line between the central portion and the first lateral portion, wherein the first lateral portion is configured to fold relative to the central portion about the first fold line; anda second fold line between the central portion and the second lateral portion, wherein the second lateral portion is configured to fold relative to the central portion about the second fold line, wherein, along a width extending between a first lateral side of the of the applicator and a second lateral side of the applicator, the first fold line and the second fold line are separated by a non-zero distance from each other.

4. The fecal collection system of claim 3, wherein the first fold line comprises a first axial segment, a first bump-out segment, and a second axial segment, wherein the first bump-out segment is between the first axial segment and the second axial segment, and wherein the first bump-out segment extends from the first axial segment and the second axial segment toward the first lateral side of the applicator. wherein the second fold line comprises a first axial segment, a second bump-out segment, and a second axial segment, wherein the second bump-out segment is between the first axial segment and the second axial segment, and wherein the second bump-out segment extends from the first axial segment and the second axial segment toward the second lateral side of the applicator.

5. The fecal collection system of claim 4, wherein the first fold line and the second fold line provide the central portion with a first lateral protrusion and a second lateral protrusion when the applicator is in a folded state, and wherein the first lateral protrusion and the second lateral protrusion are on opposing sides of the aperture of the applicator.

6. The fecal collection system of any one of claims 3-5, wherein the applicator comprises: a third fold line above the aperture and along a center axis of the applicator; and a fourth fold line below the aperture and along the center axis of the applicator.

7. The fecal collection system of any one of claims 2-6, wherein the adhesive comprises a hydrogel adhesive.

8. The fecal collection system of any one of claims 1 or 7, wherein the hydrogel adhesive has a water content between approximately 20 percent and approximately 40 percent.

9. The fecal collection system of any one of claims 1 or 7-8, wherein the hydrogel adhesive had a thickness of approximately 0.8 millimeters to approximately 1.2 millimeters.

10. The fecal collection system of any one of claims 1 or 7-9, wherein the user interface further comprises a backing, wherein the adhesive is coupled to the backing, and wherein the backing comprises a non-woven material.

11. The fecal collection system of claim 10, wherein the backing has dimensions that are larger than dimensions of the hydrogel adhesive such that hydrogel adhesive is offset inwardly from a periphery of the backing.

12. The fecal collection system of any one of claims 1-11, wherein the user interface comprises a weld ring around the aperture of the user interface, wherein the weld ring separates an outer portion of the adhesive from an inner portion of the adhesive.

13. The fecal collection system of claim 12, wherein the weld ring is formed by applying pressure to the adhesive to compress the adhesive at the weld ring while coupling the proximal end of the drainage conduit to the distal side of the user interface.

14. The fecal collection system of any one of claims 1-13, wherein the user interface comprises a first lateral side, a second lateral side opposite the first lateral side, a sacral end between the first lateral side and the second lateral side, and a perineal end opposite the sacral end, and wherein the distal side and the proximal side of the user interface extends between the first lateral side, the second lateral side, the sacral end, and the perineal end.

15. The fecal collection system of any of claim 14, wherein the aperture of the user interface is in a shape of an oval.

16. The fecal collection system of claim 15, wherein a major axis of the aperture is along a dimension that extends between the first lateral side and the second lateral side, and a minor axis of the aperture is along a dimension that extends between sacral end and the perineal end.

17. The fecal collection system of any one of claims 14-16, wherein the user interface is symmetric about a center axis that extends in the dimension between the sacral end and the perineal end, and through a center of the aperture.

18. The fecal collection system of any one of claims 14-17, wherein the sacral end comprises a sacral notch that extends towards the aperture of the user interface, and the perineal end comprises a perineal notch that extends towards the aperture of the user interface.

19. The fecal collection system of claim 18, wherein a center axis of the user interface extends through a center of the perineal notch and a center of the sacral notch.

20. The fecal collection system of any one of claims 14-19, further comprising a plurality of release liners that cover the adhesive on the proximal side of the user interface, wherein the plurality of release liners are configured to be removed to expose the adhesive.

21. The fecal collection system of claim 20, wherein the plurality of release liners comprise a center release liner, a first lateral release liner, a second lateral release liner, a third lateral release liner, and a fourth lateral release liner, wherein the center release liner is removably coupled to a center portion of the adhesive extending between the sacral end and the perineal end, wherein the center portion of the adhesive includes a portion surrounding the aperture of the user interface, a portion extending between the aperture and the sacral end, and a portion extending between the aperture and the perineal end, and wherein the first lateral release liner, the second lateral release liner, the third lateral release liner, and the fourth lateral release liner are each removably coupled to a respective quadrant of a portion of the adhesive that is not removably coupled to the center release liner.

22. The fecal collection system of claim 21, wherein the center release liner includes an aperture that is aligned with the aperture of the user interface when the center release lineris removably coupled to the adhesive.

23. The fecal collection system of any one of claims 1 -22, wherein the user interface further comprises a perineal wedge on the distal side of the user interface, and wherein the perineal wedge comprises a first wedge leg, a second wedge leg, and a vertex between the first wedge leg and the second wedge leg.

24. The fecal collection system of claim 23, wherein the vertex is at a center axis of the user interface.

25. The fecal collection system of any one of claims 23-24, wherein the first wedge leg extend (i) distally from the vertex and (ii) from the vertex towards a first lateral side of the user interface, and wherein the second wedge leg can extend (i) distally from the vertex and (ii) from the vertex towards a second lateral side of the user interface.

26. The fecal collection system of any one of claims 1-25, further comprising a collection reservoir coupled to the distal end of the drainage conduit.

27. A method of using a fecal collection system, comprising: positioning a user interface of a fecal collection system at an anus of a user, wherein the fecal collection system comprises:(i) the user interface having a proximal side and a distal side, wherein the proximal side comprises an adhesive that is configured to couple to skin of a user, wherein the user interface comprises an aperture extending through the proximal side of the user interface and the distal side of the user interface,(ii) an applicator coupled to the distal side of the user interface, wherein the applicator comprises an aperture extending through a proximal side of the applicator and a distal side of the applicator, wherein the aperture of the applicator overlaps with the aperture of the user interface; and(iii) a drainage conduit extending between a proximal end and a distal end, wherein the proximal end is coupled to the distal side of the user interface, wherein the drainage conduit defines a lumen configured to guide feces from the proximal end to the distal end;coupling the user interface to skin of the user by using the applicator to press the adhesive of the user interface against the skin of the user; and after coupling the user interface to the skin of the user, removing the applicator from the user interface.

28. The method of claim 27, wherein coupling the user interface to skin of the user comprises adhering the user interface to the skin of the user by the adhesive, and wherein the adhesive is a hydrogel adhesive.

29. The method of any one of claims 27-28, wherein the user interface comprises a weld ring around the aperture of the user interface, wherein the weld ring separates an outer portion of the adhesive from an inner portion of the adhesive, and wherein the method further comprises providing by the weld ring a barrier that inhibits saturation of the outer portion of the adhesive.

30. The method of any one of claims 27-29, further comprising removing a plurality of release liners that cover the adhesive on the proximal side of the user interface to expose the adhesive.

31. The method of claim 30, wherein the plurality of release liners comprise a center release liner, a first lateral release liner, a second lateral release liner, a third lateral release liner, and a fourth lateral release liner, wherein the center release liner is removably coupled to a center portion of the adhesive extending between a sacral end and a perineal end, wherein the center portion of the adhesive includes a portion surrounding the aperture of the user interface, a portion extending between the aperture and the sacral end, and a portion extending between the aperture and the perineal end, and wherein the first lateral release liner, the second lateral release liner, the third lateral release liner, and the fourth lateral release liner are each removably coupled to a respective quadrant of a portion of the adhesive that is not removably coupled to the center release liner.

32. The method of claim 31, wherein removing the plurality of release liners and coupling the user interface to the skin of the user comprises:removing the center release liner to expose a central portion of the adhesive around the aperture of the user interface; after removing the center release liner, coupling the central portion of the adhesive to the skin of the user; and after coupling the central portion of the adhesive to the skin of the user:(i) removing the first lateral release liner from a first portion of the adhesive and coupling the first portion of the adhesive to the skin of the user,(ii) removing the second lateral release liner from a second portion of the adhesive and coupling the second portion of the adhesive to the skin of the user,(iii) removing the third lateral release liner from a third portion of the adhesive and coupling the third portion of the adhesive to the skin of the user, and(iv) removing the fourth lateral release liner from a fourth portion of the adhesive and coupling the fourth portion of the adhesive to the skin of the user.

33. The method of any one of claims 27-32, further comprising coupling a collection reservoir to the distal end of the drainage conduit.

34. A method of forming a fecal collection system, comprising: forming a user interface having a proximal side and a distal side, wherein the proximal side comprises an adhesive that is configured to couple to skin of a user, wherein the user interface comprises an aperture extending through the proximal side of the user interface and the distal side of the user interface; coupling an applicator to the distal side of the user interface, wherein the applicator comprises an aperture extending through a proximal side of the applicator and a distal side of the applicator, wherein the aperture of the applicator overlaps with the aperture of the user interface; and coupling a drainage conduit to the distal side of the user interface, wherein the drainage conduit extends between a proximal end and a distal end, wherein the drainage conduit defines a lumen configured to guide feces from the proximal end to the distal end.

35. The method of claim 34, wherein the adhesive is a hydrogel adhesive.

36. The method of claim 35, further comprising forming the user interface by coupling the adhesive to a backing.

37. The method of claim 36, wherein coupling the adhesive to the backing comprises coupling the adhesive to the backing by an acrylic using a cold lamination process to achieve an offset between a periphery of the hydrogel adhesive and a periphery of the backing, wherein the backing has dimensions that are larger than dimensions of the adhesive such that adhesive is offset inwardly from the periphery of the backing.

38. The method of any one of claims 34-37, further comprising forming a weld ring on the adhesive such that the weld ring provides a barrier separating an outer portion of the adhesive from an inner portion of the adhesive.

39. The method of claim 38, wherein forming the weld ring comprises applying pressure to the adhesive to compress the adhesive at the weld ring while coupling the proximal end of the drainage conduit to the distal side of the user interface.

40. The method of claim 39, wherein coupling the proximal end of the drainage conduit to the distal side of the user interface comprises applying an impulse weld to the drainage conduit and the user interface at the weld ring.

41. The method of claim 40, wherein coupling the proximal end of the drainage conduit to the distal side of the user interface comprises folding a portion of the drainage conduit over on itself at a fold line and applying the impulse weld at the fold line.

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