Fecal collection system and method

Abstract

In one example, a feces collection system includes a user interface assembly, a drainage conduit, and a collection reservoir. The user interface assembly includes a user interface and an applicator. The user interface has a proximal surface and a distal surface. The proximal surface is configured to interface with the skin of a user. The applicator is interfaced with the distal surface of the user interface. The applicator is removable from the user interface while the user interface remains interfaced with the user. The drainage conduit extends between a proximal end and a distal end. The proximal end is configured to interface with the distal surface of the user interface. The drainage conduit defines a lumen configured to direct feces from the proximal end to the distal end. The collection reservoir is coupled to the distal end of the drainage conduit.

Description

[Technical field]

[0001] The present disclosure relates generally to fecal collection devices and systems that collect feces expelled from a user's body and transport the feces away from the body.

[0002] [CROSS REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 319,790, filed March 15, 2022, and U.S. Provisional Patent Application No. 63 / 355,853, filed June 27, 2022, the contents of which are incorporated by reference in their entireties. [Background technology]

[0003] In various circumstances, a user may have limited or impaired mobility such that normal bowel function and processes become difficult (or impossible). For example, a person may have impaired mobility due to an injury or may be bedridden due to injury or illness. Also, fecal collection may be required for monitoring purposes, such as for monitoring input and output in a clinical environment (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 conditions associated with obstruction or restriction of the bowel process. However, conventional approaches have inherent problems or limitations. Summary of the Invention

[0005] In one example, a feces collection system is described. The feces collection system includes a user interface assembly, a drainage conduit, and a collection reservoir. The user interface assembly includes a user interface and an applicator. The user interface has a proximal surface and a distal surface. The proximal surface is configured to interface with the skin of a user. The applicator is coupled to the distal surface of the user interface. The applicator is removable from the user interface while the user interface remains coupled to the user. The drainage conduit extends between a proximal end and a distal end. The proximal end is configured to interface with the distal surface of the user interface. The drainage conduit defines a lumen configured to direct feces from the proximal end to the distal end. The collection reservoir is coupled to the distal end of the drainage conduit.

[0006] In another example, a method of using a fecal collection system is described. The method includes positioning a user interface assembly at a user's anus. The user interface assembly includes a user interface and an applicator. The method also includes coupling the user interface to the skin of the user by pressing the user interface against the skin of the user using the applicator. The method further includes removing the applicator from the user interface after coupling the user interface to the skin of the user.

[0007] The above-described features, functions, and advantages may be achieved independently in various embodiments or may be combined in yet other embodiments, further details of which can be seen in the following description and by reference to the drawings.

[0008] The novel features believed distinctive to the illustrative embodiments are set forth in the appended claims, however, the illustrative embodiments will be best understood by reference to the following detailed description of the illustrative embodiments of the present disclosure, together with the preferred mode of use, further objects and description thereof, when read in conjunction with the accompanying drawings. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 is a simplified block diagram of a feces collection system according to an example. [Diagram 2] FIG. 2 illustrates an implementation of the feces collection system shown in FIG. 1, according to an example. [Figure 3A] 2A-2C illustrate a process of bonding a user interface assembly to a user's skin according to one exemplary embodiment of the user interface assembly shown in FIG. 1. [Figure 3B] 2A-2C illustrate a process of bonding a user interface assembly to a user's skin according to one exemplary embodiment of the user interface assembly shown in FIG. 1. [Figure 3C] 2A-2C illustrate a process of bonding a user interface assembly to a user's skin according to one exemplary embodiment of the user interface assembly shown in FIG. 1. [Figure 3D] 2A-2C illustrate a process of bonding a user interface assembly to a user's skin according to one exemplary embodiment of the user interface assembly shown in FIG. 1. [Figure 4] FIG. 1 illustrates a proximal side of a user interface according to an example. [Diagram 5] FIG. 1 illustrates an example of a drain conduit and collection reservoir. [Figure 6] FIG. 2 illustrates an implementation of the feces collection system shown in FIG. 1 according to another example. [Figure 7] FIG. 7 illustrates a distal face of the applicator of the feces collection system shown in FIG. 6 according to one example. [Figure 8A] FIG. 7 illustrates a user interface of the feces collection system shown in FIG. 6 in a folded state, according to an example. [Figure 8B] FIG. 7 illustrates a user interface of the feces collection system shown in FIG. 6 according to an example. [Figure 9A]7A-7D illustrate a process for connecting the feces collection system of FIG. 6 to a user, according to one example. [Figure 9B] 7A-7D illustrate a process for connecting the feces collection system of FIG. 6 to a user, according to one example. [Figure 9C] 7A-7D illustrate a process for connecting the feces collection system of FIG. 6 to a user, according to one example. [Figure 9D] 7A-7D illustrate a process for connecting the feces collection system of FIG. 6 to a user, according to one example. [Figure 9E] 7A-7D illustrate a process for connecting the feces collection system of FIG. 6 to a user, according to one example. [Figure 9F] 7A-7D illustrate a process for connecting the feces collection system of FIG. 6 to a user, according to one example. [Figure 9G] 7A-7D illustrate a process for connecting the feces collection system of FIG. 6 to a user, according to one example. [Figure 9H] 7A-7D illustrate a process for connecting the feces collection system of FIG. 6 to a user, according to one example. [Figure 9I] 7A-7D illustrate a process for connecting the feces collection system of FIG. 6 to a user, according to one example. [Figure 9J] 7A-7D illustrate a process for connecting the feces collection system of FIG. 6 to a user, according to one example. [Figure 10A] FIG. 1 illustrates a distal surface of a user interface according to an example. [Figure 10B] FIG. 10B illustrates a proximal view of the user interface shown in FIG. 10A according to an example. [Figure 11A] FIG. 13 is a diagram illustrating a user interface according to another example. [Figure 11B] FIG. 11B illustrates the user interface of FIG. 11A interfaced to a user, according to an example. [Figure 12A] FIG. 13 illustrates a user interface assembly in a first configuration according to another example. [Figure 12B] FIG. 12B illustrates the user interface assembly of FIG. 12A in a second configuration, according to an example. [Figure 12C] FIG. 12B illustrates the user interface assembly of FIG. 12A in a first configuration during application of the user interface assembly to a user, according to one example. [Figure 13A] FIG. 13 illustrates a user interface assembly in a first configuration according to another example. [Figure 13B] FIG. 13B illustrates the user interface assembly of FIG. 13A in a first configuration during application of the user interface assembly to a user, according to one example. [Figure 14] FIG. 1 is a perspective view of an applicator according to an example. [Figure 15] FIG. 15 is a first side view of the applicator shown in FIG. 14 according to the example. [Figure 16] FIG. 15 is a second side view of the applicator shown in FIG. 14 according to the example. [Figure 17] FIG. 15 is a first side view of the applicator shown in FIG. 14 according to the example. [Figure 18] FIG. 15 is a second side view of the applicator shown in FIG. 14 according to the example. [Figure 19] FIG. 15 is a first side view of the applicator shown in FIG. 14 according to the example. [Figure 20] FIG. 15 is a second side view of the applicator shown in FIG. 14 according to the example. [Figure 21] FIG. 13 is a diagram illustrating a user interface according to another example. [Figure 22A] FIG. 1 illustrates a collection reservoir with the cap in a closed position, according to one example. [Figure 22B] FIG. 22B illustrates the collection reservoir of FIG. 22A with the cap in an open position, according to one example. [Diagram 23] 1 is a flow chart of a process for using a feces collection system according to an example. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The disclosed embodiments are described more fully below with reference to the accompanying drawings. The drawings show some, but not all, of the disclosed embodiments. Indeed, several different embodiments may be described, but should not be construed as being limited to the embodiments described 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.

[0011] 1, a simplified block diagram of a fecal collection system 100 according to one example is shown. As shown in FIG 1, fecal collection system 100 includes a user interface assembly 110, a drainage conduit 112, and a collection reservoir 114. Fecal collection system 100 may be bonded or coupled to a user's skin such that fecal collection system 100 is external to the user's body.

[0012] The user interface assembly 110 includes a user interface 116 and an applicator 118. The user interface 116 has a proximal surface and a distal surface. The proximal surface is configured to bond to the skin of a user. For example, the user interface 116 can include an adhesive sheet 120 on the proximal surface. As one example, the adhesive sheet 120 can include a biocompatible adhesive, such as, for example, a silicone adhesive, that can be adapted to bond the user interface 116 to the skin of a user. In one example, the adhesive sheet 120 can be configured to bond the user interface 116 to the skin of a user for at least 8 hours before removal and / or replacement. In another example, the adhesive sheet 120 can be configured to bond the user interface 116 to the skin of a user for about 12 hours to about 72 hours before removal and / or replacement.

[0013] The applicator 118 is attached to a distal surface of the user interface 116. The applicator 118 is removable from the user interface 116 while the user interface 116 remains attached to the user. In this configuration, the applicator 118 can aid in attaching the user interface 116 to the skin of the user and can be removed in preparation for attaching the drainage conduit 112 to the user interface 116 and / or can reduce the amount of material of the feces collection system 100 between the user and a support structure (e.g., a hospital bed and / or wheelchair). In this manner, removing the applicator 118 can help reduce the risk of pressure sores.

[0014] The discharge conduit 112 extends between a proximal end and a distal end. In one example, the proximal end of the discharge conduit 112 can be fixedly joined to a distal surface of the user interface 116 before the applicator 118 is removed from the user interface 116. In this example, the discharge conduit 112 can be joined to the user interface 116 while the user interface 116 is joined to the skin of the user. In another example, the proximal end is configured to be joined to a distal surface of the user interface 116 after the applicator 118 is removed from the user interface 116. More generally, the discharge conduit 112 defines a lumen configured to direct feces from the proximal end to the distal end. The collection reservoir 114 is joined to the distal end of the discharge conduit 112. The collection reservoir 114 is configured to contain feces.

[0015] The exhaust conduit 112 and lumen can have an elongated shape. In one example, the exhaust conduit 112 can have a length of about 4 feet to about 6 feet. This length can be useful for positioning the collection reservoir 114 away from a user (e.g., to the side of a patient support structure such as a hospital bed). However, the exhaust conduit 112 can have a different length in other examples.

[0016] Additionally, in some examples, the discharge conduit 112 can be configured to direct feces from the proximal end to the distal end in response to squeezing the discharge conduit 112 toward the collection reservoir 114 (e.g., by applying a compressive force to the discharge conduit 112 along the length of the discharge conduit 112 in a direction from the proximal end to the distal end). For example, the discharge conduit 112 can have a hardness and / or flexibility that facilitates manually squeezing the feces toward the collection reservoir 114. Also by way of example, the discharge conduit 112 can be formed from polyurethane (PU) and / or polyvinyl chloride (PVC). For example, the discharge conduit 112 can be a film tube having a thickness of about 2 mils to about 4 mils.

[0017] In some embodiments, the discharge conduit 112 can be at least partially transparent or translucent. This can be useful in determining whether feces is present in the discharge conduit 112 so that a decision can be made to squeeze the discharge conduit 112 and pump the feces into the collection reservoir 114.

[0018] In an alternative example, fecal collection system 100 can omit drain conduit 112 such that collection reservoir 114 is directly connected to user interface 116. This can reduce manufacturing costs and reduce the need to squeeze drain conduit 112, but it positions collection reservoir 114 closer to the user, increasing the bulk of the device that may come into contact with the user, and making replacement of collection reservoir 114 more difficult.

[0019] As mentioned above, the user interface 116 can include an adhesive sheet 120. The adhesive sheet 120 can define holes that communicate with the lumen of the drainage conduit 112. In this configuration, feces can pass from the user's anus through the holes in the adhesive sheet 120 and into the drainage conduit 112. The drainage conduit 112 can then direct the feces to the collection reservoir 114.

[0020] In one example, the holes in the adhesive sheet 120 can have a diameter of about 1.5 inches. This can help provide a large enough opening in the drainage conduit 112 to receive the feces while allowing a surface area of ​​the adhesive sheet 120 to secure the feces collection system 100 to the user's skin. In another example, the holes in the adhesive sheet 120 can have a diameter of about 1 inch to about 2 inches.

[0021] In some embodiments, the user interface 116 may also include a collar 122 extending distally from the adhesive sheet 120. As discussed above, the adhesive sheet 120 may include an adhesive, such as, for example, a silicone adhesive, which may be intended to bond the user interface 116 to the skin of a user. The proximal end of the exhaust conduit 112 may be bonded to the collar 122 of the user interface 116. For example, the collar 122 may be a foam wedge that may be received on the proximal end of the exhaust conduit 112. Thus, in this example, the collar 122 may be bonded to the exhaust conduit 112 by a friction-fit connection. However, in other examples, the collar 122 may additionally or alternatively be bonded to the exhaust conduit 112 by a threaded connection, a hook and loop connection, and / or an adhesive connection.

[0022] More generally, the collar 122 can be configured to facilitate coupling, uncoupling, and / or recoupling one or more of the exhaust conduits 112 to the user interface 116. Thus, the collar 122 can facilitate replacing the exhaust conduits 112 and / or the collection reservoir 114 without removing the user interface 116 from the user. For example, a method of using the fecal collection system 100 can include removing a first exhaust conduit 112 from the user interface 116 after an initial period of use (e.g., about 8 hours) and coupling a second exhaust conduit 112 to the user interface 116.

[0023] In one example, the collar 122 can define a first hole that communicates with the lumen of the discharge conduit 112, and the adhesive sheet 120 can define a second hole that is axially aligned with the first hole of the collar 122. In this configuration, feces can pass from the user's anus through the first hole of the collar 122 and the second hole of the adhesive sheet 120 and into the discharge conduit 112. The discharge conduit 112 can then direct the feces to the collection reservoir 114.

[0024] In one example, the first hole and the second hole can have a diameter of about 1.5 inches. This can help provide a large enough opening to receive the feces into the drainage conduit 112 while allowing a surface area of ​​the adhesive sheet 120 to secure the feces collection system 100 to the skin of a user. In another example, the first hole and / or the second hole can have a diameter of about 1 inch to about 2 inches.

[0025] In one example, fecal collection system 100 can also include a first one-way valve 124 within the lumen defined by discharge conduit 112. First one-way valve 124 is configured to allow feces to flow in a direction from the proximal end to the distal end of discharge conduit 112, but to prevent feces from flowing in a direction from the distal end to the proximal end of discharge conduit 112. This can help prevent feces from backing up and contacting the user's skin.

[0026] In one example, the first one-way valve 124 can be configured to transition from a closed state to an open state in response to feces passing distally through the first one-way valve 124 (e.g., from the user toward the drain conduit 112). In the closed state, the first one-way valve 124 can prevent feces from flowing back proximally toward the user (e.g., toward the user interface assembly 110). In the open state, the first one-way valve 124 can expand to define an enlarged passage that allows feces to pass distally through the first one-way valve 124. In one embodiment, the first one-way valve 124 can be configured to expand to have a diameter approximately equal to a diameter of the drain conduit 112. For example, in one embodiment in which the exhaust conduit 112 has a diameter of approximately 38.1 millimeters (approximately 1.5 inches), the first one-way valve 124 can expand from a diameter of approximately zero millimeters (approximately zero inches) in a closed state to a diameter of approximately 38.1 millimeters (approximately 1.5 inches) in an open state.

[0027] In one exemplary embodiment, the first one-way valve 124 can include multiple flaps extending distally from a proximal end of the exhaust conduit 112 (e.g., holes in the adhesive sheet 120). In this configuration, the flaps can taper toward each other along the length of the flaps in a direction from the proximal end of the exhaust conduit 112 to the distal end of the exhaust conduit 112. In one example, the material of the flaps can be the same as the material of the exhaust conduit 112. The flaps can be monolithic (e.g., integral) with the exhaust conduit 112, or the flaps can be separate structures that are joined (e.g., by welding) to the exhaust conduit 112.

[0028] The collection reservoir 114 may additionally or alternatively include a second one-way valve 126 configured to allow feces to flow from the discharge conduit 112 to the collection reservoir 114, but prevent feces from flowing from the collection reservoir 114 back into the discharge conduit 112. This may also help prevent feces from backing up and contacting the user's skin. In one example, the discharge conduit 112 may have a diameter of about 25.4 millimeters to about 76.2 millimeters (about 1 inch to about 3 inches) at the distal end 212B.

[0029] FIG 2 illustrates one embodiment of a feces collection system 100, according to one example. As shown in FIG 2, feces collection system 100 includes a user interface assembly 110, a discharge conduit 112, and a collection reservoir 114, as described above. As described above, user interface assembly 110 includes a user interface 116 having a proximal surface 216A and a distal surface 216B. Additionally, in FIG 2, discharge conduit 112 extends between a proximal end 212A and a distal end 212B.

[0030] As shown in FIG. 2, the discharge conduit 112 can be configured to be attached, detached, and reattached to the collection reservoir 114. This can facilitate the detachment of a first collection reservoir 114 containing feces and the attachment of an empty second collection reservoir 114 to continue collecting feces without the need to detach the user interface 116 and / or the discharge conduit 112 from the skin of the user. In some examples, the discharge conduit 112 and the collection reservoir 114 can be attached, detached, and reattached to the user interface 116 while the user interface 116 remains attached to the skin of the user. This can facilitate the replacement of the discharge conduit 112 and / or the collection reservoir 114 without removing the user interface 116 from the user. In other examples, the discharge conduit 112 can be permanently fixed to the collection reservoir 114. This can help reduce the risk of leakage at the interface between the user interface 116 and the discharge conduit 112.

[0031] 2, the collection reservoir 114 can include a measurement window 230 that includes a number of volume indicia 232. The measurement window 230 can be at least one of transparent and translucent to allow for visualization of the amount of feces in the collection reservoir 114. This can provide an indication of when the collection reservoir 114 should be replaced and / or when a sufficient volume of feces has been collected to provide a sample for diagnostic evaluation.

[0032] 2, the first one-way valve 124 is positioned at the proximal end 212 A. In other examples, the first one-way valve 124 can be positioned between the proximal end 212 A and the distal end 212 B of the exhaust conduit 112.

[0033] 3A-3D illustrate a process of bonding user interface assembly 110 to a user's skin, according to one exemplary embodiment of user interface assembly 110. As shown in FIGS. 3A-3D, user interface assembly 110 includes user interface 116 and applicator 118. In FIG. 3A, user interface assembly 110 is positioned at user's anus 340. User interface assembly 110 is folded such that proximal surface 216A of user interface 116 faces outward and distal surface 216B of user interface 116 faces inward.

[0034] In FIG. 3B, the applicator 118 is used to press the proximal surface 216A of the user interface 116 against the skin 342 of the user. In this example, the applicator 118 includes a first side portion 318A and a second side portion 318B that are hingedly movable relative to one another. For example, the applicator 118 can include a hinge portion 318C between the first side portion 318A and the second side portion 318B. In this example, the hinge portion 318C is perforated to aid in removing the applicator 118 from the user interface 116. As shown in FIG. 3B, the first side portion 318A of the applicator 118 and the second side portion 318B of the applicator 118 can be moved relative to one another to press the user interface 116 against the skin 342 of the user.

[0035] In FIG. 3C, the applicator 118 is removed from the user interface 116. For example, the applicator 118 can be removed from the user interface 116 by decoupling the first side portion 318A and the second side portion 318B from the user interface 116 along the perforations of the hinge portion 318C. As shown in FIG. 3C and FIG. 3D, removing the applicator 118 can expose the collar 122 of the user interface 116. In FIG. 3D, the user interface 116 is bonded to the skin 342 of a user. As shown in FIG. 3D, the adhesive sheet 120 is bonded to the skin 342, with the collar 122 extending distally from the adhesive sheet 120. Also in FIG. 3D, collar 122 defines a first hole 344 and adhesive sheet 120 defines a second hole 346, with first hole 344 and second hole 346 aligned with the user's anus 340.

[0036] Figure 4 illustrates the proximal surface 216A of the user interface 116 according to one example. In Figure 4, the user interface 116 includes a release liner 448 that covers and adheres to the proximal surface 216A of the user interface 116. The release liner 448 can be removed to expose the adhesive prior to bonding the user interface 116 to a user's skin.

[0037] FIG. 5 shows the exhaust conduit 112 and collection reservoir 114 according to one exemplary embodiment.

[0038] 6, fecal collection system 600 is shown as one embodiment of fecal collection system 100 according to another example. As shown in FIG. 6, fecal collection system 600 includes user interface assembly 110, discharge conduit 112, and collection reservoir 114, as described above. As described above, user interface assembly 110 includes user interface 116 having proximal and distal faces. Additionally, in FIG. 6, discharge conduit 112 extends between proximal end 612A and distal end 612B.

[0039] 6, the discharge conduit 112 can be configured to be attached, detached, and reattached to the collection reservoir 114. This allows for the attachment of a first collection reservoir 114 containing feces and the attachment of an empty second collection reservoir 114 to continue collecting feces without the need to detach the user interface 116 from the user's skin. In other examples, the discharge conduit 112 can be permanently secured to the collection reservoir 114. In such examples, the discharge conduit 112 and collection reservoir 114 can be attached, detached, and reattached to the user interface 116 while the user interface 116 remains attached to the user's skin (e.g., in other examples, the user interface assembly 110 can further include a collar 122 as described above).

[0040] 6, the distal end 612B of the exhaust conduit 112 comprises a male quick connect coupler 650A that can be mated to a female quick connect coupler 650B of the collection reservoir 114. The female quick connect coupler 650B of the collection reservoir 114 further comprises an actuator 650C (e.g., a button) that is operable to couple and / or decouple the male quick connect coupler 650A and the female quick connect coupler 650B relative to one another. In this configuration, the exhaust conduit 112 can remain securely coupled to the collection reservoir 114 until the actuator 650C is operated to decouple the male quick connect coupler 650A of the exhaust conduit 112 from the female quick connect coupler 650B of the collection reservoir 114. This can help to inhibit (or prevent) accidental decoupling of the exhaust conduit 112 and the collection reservoir 114. In FIG. 6, the discharge conduit 112 is provided with a male quick connect coupler 650A and the collection reservoir 114 is provided with a female quick connect coupler 650B, however in alternative examples, the discharge conduit 112 may be provided with a female quick connect coupler 650B and the collection reservoir 114 may be provided with a male quick connect coupler 650A.

[0041] Additionally, as discussed above, the collection reservoir 114 can include a measurement window with multiple volume indicia (e.g., similar to the collection reservoir 114 shown in Figures 2 and 5). The measurement window can be transparent and / or translucent to allow visualization of the amount of feces in the collection reservoir. This can provide an indication of when the collection reservoir should be replaced and / or when a sufficient volume of feces has been collected to provide a sample for diagnostic evaluation.

[0042] 6, the proximal end 612A of the exhaust conduit 112 is joined to a distal surface of the user interface 116. In this example, the exhaust conduit 112 can be non-removably joined (e.g., fixedly and permanently joined) to the user interface 116. For example, the proximal end 612A of the exhaust conduit 112 can be welded to the adhesive sheet 120 at a hole 646 in the adhesive sheet 120.

[0043] FIG. 7 illustrates an applicator 118 according to the example shown in FIG. 6. As shown in FIG. 7, the applicator 118 includes a first side portion 718A, a second side portion 718B, and a hinge portion 718C between the first side portion 718A and the second side portion 718B. In this configuration, the first side portion 718A and the second side portion 718B are configured to move about the hinge portion 718C between an unfolded state (shown in FIG. 7) and a folded state (shown in FIGS. 8A and 8B). As described below, the folded state can be useful for inserting the applicator 118 and the user interface 116 between the buttocks to access the user's anus. The unfolded state can be useful for removing the applicator 118 from the user interface 116, as described above.

[0044] The hinge portion 718C is further configured to facilitate removal of the applicator 118 from the user interface 116. For example, in FIG. 7, the hinge portion 718C comprises a first bridge portion 752A and a second bridge portion 752B that connect a first side portion 718A of the applicator 118 to a second side portion 718B of the applicator 118 (e.g., the first side portion 718A and the second side portion 718B may be joined to one another only at the first bridge portion 752A and the second bridge portion 752B). The first bridge portion 752A and the second bridge portion 752B may have a relatively small size relative to the overall size of the applicator 118 in a dimension extending along an intersection line between the first side portion 718A and the second side portion 718B. For example, the combined length of the first bridge portion 752A and the second bridge portion 752B in this dimension may be less than about 50% of the overall length of the applicator 118. This relative size may be intended to (i) prevent inadvertent separation of the first side portion 718A and the second side portion 718B while joining the user interface 116 to a user, and (ii) allow the first side portion 718A and the second side portion 718B to be easily torn away from one another after joining the user interface 116 to a user.

[0045] In some embodiments, the first bridge portion 752A and / or the second bridge portion 752B can include perforations to assist in decoupling the first and second side portions 718A, 718B from one another. The perforations can allow the combined length of the first and second bridge portions 752A, 752B to be greater than about 50 percent of the overall length of the applicator 118 in a dimension extending along the intersection line between the first and second side portions 718A, 718B (e.g., along the hinge portion 718C).

[0046] 7, the exhaust conduit 112 passes through a hole 754 in the applicator 118. The first bridge portion 752A is defined between the hole 754 and a slit 756 that extends along a hinge portion 718C between the first and second side portions 718A, 718B of the applicator 118. The slit 756 may serve to reduce the size of the first bridge portion 752A relative to the overall size of the applicator 118 along the boundary between the first and second side portions 718A, 718B. The slit 756 may additionally or alternatively serve to improve the mobility of the first and second side portions 718A, 718B about the hinge portion 718C.

[0047] In one example, the slit 756 can have a length in a dimension extending along the hinge portion 718C (e.g., through the first bridge portion 752A, the hole 754, and the second bridge portion 752B) that is greater than about 40 percent of the overall length of the applicator 118. This can help achieve the functions of the slit 756 described above.

[0048] The second bridge portion 752B can be defined between an aperture 754 (e.g., a point opposite the first bridge portion 752A) and a periphery of the applicator 118 at the hinge portion 718C. As shown in FIG. 7, the aperture 754 can be offset from the center of the applicator 118. More specifically, the aperture 754 can be closer to a lower edge of the applicator 118 than to an upper edge of the applicator 118. Thus, the proximal end of the discharge conduit 112 can be joined to the user interface 116 at a location offset below the center of the user interface 116. This can be useful for applying the user interface 116 to a user's anus, which is generally located below the center of the user's buttocks.

[0049] 7, applicator 118 may further include a first tab 758A at a periphery of first side portion 718A and a second tab 758B at a periphery of second side portion 718B. The first tab 758A and the second tab 758B may extend laterally beyond the periphery of user interface 116 such that applicator 118 may be easily grasped and handled when user interface assembly 110 is positioned between a user's buttocks.

[0050] 8A and 8B show the user interface 116 and the applicator 118 in a folded state, with the first side portion 718A and the second side portion 718B folded about the hinge portion 718C such that the user interface 116 is positioned outwardly relative to the applicator 118. As shown in FIG. 8A, the applicator 118 can have a size larger than the user interface 116 (e.g., the first tab 758A and the second tab 758B can extend beyond the periphery of the user interface 116). This can help provide access to the applicator 118. In another example, the applicator can have a size approximately equal to the size of the user interface 116. More generally, the user interface 116 and the applicator 118 can be configured to contemplate holding the user interface 116 and the applicator 118 in one hand while the user interface 116 and the applicator 118 are in the folded state.

[0051] In Figures 8A and 8B, the user interface 116 comprises an adhesive sheet 120 (shown in Figure 8B), a first release liner 860, and a second release liner (not shown in Figures 8A and 8B). The first release liner 860 is removably attached to a first half of the adhesive sheet 120 (e.g., on a first side of the hinge portion 718C and holes 754 in Figures 8A and 8B), and the second release liner is removably attached to a second half of the adhesive sheet 120 (e.g., on a second side of the hinge portion 718C and holes 754 in Figures 8A and 8B). In this configuration, the first release liner 860 and the second release liner can be removed independently from the adhesive sheet 120 with the intention of attaching the user interface 116 to a user's skin one side at a time.

[0052] The first release liner 860 can include a first portion 860A and a second portion 860B. The first portion 860A can cover a first half of the adhesive sheet 120 to prevent premature or inadvertent adhesion of the adhesive sheet 120 to an object prior to application of the user interface 116 to a user. The second portion 860B can have a first end joined to the first portion 860A at an inner portion of the user interface 116 (e.g., at the hole 754) and a second end separated from the first portion 860A at an outer portion of the user interface 116 (e.g., at the periphery of the user interface 116). In this configuration, a practitioner can grasp the second end at the periphery of the user interface 116 and pull it outwardly away from the user to separate the first portion 860A of the first release liner 860 from the adhesive sheet 120. In this manner, the first release liner 860 can gradually expose the first half of the adhesive sheet 120 in a direction from the hole 754 toward the periphery of the user interface 116. This can help improve attachment of the adhesive sheet 120 to the user's buttocks, with the hole 754 aligned with the user's anus.

[0053] Although not shown in FIGS. 8A and 8B, a second release liner can be similarly positioned relative to the second half of the adhesive sheet 120. The second release liner can thus include a first portion and a second portion. The first portion of the second release liner can cover the second half of the adhesive sheet 120 to prevent premature or inadvertent adhesion of the adhesive sheet 120 to an object prior to application of the user interface 116 to a user. The second portion can have a first end joined to the first portion at an inner portion of the user interface 116 (e.g., at the hole 754) and a second end separated from the first portion at an outer portion of the user interface 116 (e.g., at the periphery of the user interface 116). In this configuration, a practitioner can grasp the second end at the periphery of the user interface 116 and pull it outwardly away from the user to separate the first portion of the second release liner from the adhesive sheet 120. In this manner, the second release liner can gradually expose the second half of the adhesive sheet 120 in a direction from the hole 754 toward the periphery of the user interface 116. This can help improve attachment of the adhesive sheet 120 to the user's buttocks, with the hole 754 aligned with the user's anus.

[0054] 8B, the first and second halves of the adhesive sheet 120 can each include a gripping area 864. The gripping area 864 can be located on an outer edge of the adhesive sheet 120 and can be devoid of adhesive, which can allow a practitioner to hold the gripping area 864 in order to manipulate and handle the adhesive sheet 120 while applying the adhesive sheet 120 to the user's buttocks. The gripping area 864 can also aid in easier removal of the adhesive sheet 120 from the user, as compared to alternative embodiments in which the adhesive extends across the entire surface area of ​​the adhesive sheet 120.

[0055] Additionally, as shown in FIG. 8B, the user interface 116 and / or the applicator 118 may include alignment indicators 866 that may aid in aligning the holes 754 and the drainage conduit 112 with respect to the user's anus. For example, in FIG. 8B, the alignment indicator 866 includes a first line that extends from the top of the holes 754 in the applicator 118 to the periphery of the adhesive sheet 120 and a second line that extends from the bottom of the holes 754 in the applicator 118 to the periphery of the adhesive sheet 120. In this configuration, the alignment indicator 866 may provide a visual indication of the location of the drainage conduit 112 positioned between the holes 754 in the applicator 118, the holes 646 (shown in FIG. 6) in the user interface 116, and the buttocks, even when the holes 754 and 646 cannot be directly visualized.

[0056] 9A-9J, the process of joining the fecal collection system 600 to a user is shown in accordance with one exemplary embodiment of the user interface assembly 110. In FIG. 9A, the user interface assembly 110 is inserted between the buttocks of the user. For example, when the applicator 118 is in a folded state, the healthcare professional can hold the first tab 758A and the second tab 758B of the applicator 118 with the gripping area 864 of the adhesive sheet 120. As shown in FIG. 9A, this allows the healthcare professional to hold the user interface assembly 110 away from the buttocks while positioning the hole in the user interface 116 and the drainage conduit 112 with the anus.

[0057] 9B, first release liner 860 is removed from the first half of adhesive sheet 120. For example, a medical professional can grasp the second end at the periphery of user interface 116 and pull it outwardly away from the user to separate first portion 860A of first release liner 860 from adhesive sheet 120. In this manner, first release liner 860 can gradually expose the first half of adhesive sheet 120 in a direction from hole 754 toward the periphery of user interface 116.

[0058] 9C, after removing the first release liner 860 from the adhesive sheet 120, the medical practitioner can use the alignment indicator 866 to determine the location of the stoma relative to the user's anus. In some examples, the medical practitioner can use the applicator 118 to adjust the position of the user interface 116 relative to the user based on the location of the alignment indicator relative to the user's anus.

[0059] In Fig. 9D, the first half 920A of the adhesive sheet 120 can be joined to the skin of the user at the first buttocks. In addition, as shown in Fig. 9D, the healthcare professional can use one hand to hold the applicator 118 in place at the anus while using the other hand to place the first half 920A of the adhesive sheet 120 on the first buttocks (e.g., by holding the gripping region 864 of the adhesive sheet 120).

[0060] 9E, the second release liner 960 is removed from the second half of the adhesive sheet 120. For example, a medical professional can grasp the second end at the periphery of the user interface 116 and pull it outwardly away from the user to separate the first portion 960A of the second release liner 960 from the adhesive sheet 120. In this manner, the second release liner 960 can gradually expose the second half of the adhesive sheet 120 in a direction from the hole 754 toward the periphery of the user interface 116.

[0061] In Fig. 9F, the second half 920B of the adhesive sheet 120 can be joined to the skin of the user at the second buttocks. In addition, as shown in Fig. 9F, the healthcare professional can use one hand to hold the applicator 118 in place at the anus while using the other hand to place the second half 920B of the adhesive sheet 120 on the second buttocks (e.g., by holding the gripping region 864 of the adhesive sheet 120).

[0062] FIG. 9G illustrates the applicator 118 being removed from the user interface 116, and FIG. 9H illustrates the user interface 116 and the exhaust conduit 112 after the applicator 118 has been removed from the user interface 116. For example, as shown in FIG. 9G, the first and second side portions 718A and 718B can be torn away from one another (e.g., at the first and / or second bridge portions 752A and 752B). This can facilitate complete removal of the applicator 118, which can help improve comfort for the user and reduce pressure on the user's buttocks. However, in another example, the applicator 118 can be disengaged from the remaining portions of the user interface 116 (e.g., the adhesive sheet 120 and collar 122) and moved distally along the exhaust conduit 112 away from the user (e.g., with the first and second bridge portions 752A and 752B intact). Figures 9I and 9J show that the distal end 612B of the exhaust conduit 112 is coupled to the collection reservoir 114. As shown in Figures 9I and 9J, the collection reservoir 114 can be coupled to the side of a patient support structure (e.g., a hospital bed).

[0063] 3A-9J, applicator 118 includes first side portion 318A, 718A and second side portion 318B, 718B, although applicator 118 can have different configurations in other examples. Figures 10A-13B show aspects of user interface 116 and / or applicator 118 according to some other examples.

[0064] 10A and 10B illustrate a user interface 1016 as one embodiment of the user interface 116 according to another example. As shown in FIG. 10A and 10B, the user interface 1016 can include an adhesive sheet 1020, a release liner 1060, and holes 1046 in the adhesive sheet 1020. The adhesive sheet 1020 can be substantially similar or identical to the adhesive sheet 120 described above, except that the adhesive sheet 1020 in FIG. 10A and 10B can have a different shape. For example, in FIG. 10A and 10B, the adhesive sheet 1020 can include a number of arms extending outwardly from a central portion. The central portion of the adhesive sheet 1020 can define the holes 1046.

[0065] In addition, the user interface 1016 includes a sacral pressure pad 1068. The sacral pressure pad 1068 can extend from a top edge of the adhesive sheet 1020 such that when the adhesive sheet 1020 is bonded to a user's skin with the holes 1046 aligned with the user's anus, the sacral pressure pad 1068 is configured to lie adjacent to the user's sacrum. The sacral pressure pad 1068 can have a thickness and flexibility that helps reduce pressure on the sacrum when the sacral pressure pad 1068 is positioned between the user's sacrum and a support surface (e.g., a hospital bed and / or wheelchair).

[0066] In some examples, the sacral pressure pad 1068 can include an adhesive configured to bond the sacral pressure pad 1068 to the sacrum of a user. In such examples, the release liner 1060 can also include a sacral portion that covers the adhesive on the sacral pressure pad 1068 prior to adhering the sacral pressure pad 1068 to a user.

[0067] Similar to the first and second release liners described above, the sacral portion of the release liner 1060 can include a first portion 1060A and a second portion 1060B. The first portion 1060A can cover the adhesive on the sacral pressure pad 1068 to prevent the adhesive from prematurely or inadvertently attaching to an object prior to application of the user interface 116 to a user. The second portion 1060B can have a first end joined to the first portion 1060A at an inner portion of the sacral pressure pad 1068 (e.g., the end closest to the adhesive sheet 1020) and a second end separated from the first portion 1060A at an outer portion of the sacral pressure pad 1068 (e.g., the end furthest from the adhesive sheet 1020). In this configuration, a practitioner can grasp the second end of the second portion 1060B and pull it outwardly away from the user and the adhesive sheet 1020 to separate the first portion 1060A of the release liner 1060 from the adhesive on the sacral pressure pad 1068. In this manner, the release liner 1060 can gradually expose the adhesive on the sacral pressure pad 1068 in a direction from the adhesive sheet 1020 toward the periphery of the user interface 116. This can help improve bonding of the adhesive to the sacrum.

[0068] 11A and 11B show a user interface 1116 as one embodiment of a user interface 116 according to another example. As shown in FIG. 11A and 11B, the user interface 1116 can include an adhesive sheet 1120, a release liner 1160, holes 1146 in the adhesive sheet 1120, and a sacral pressure pad 1168. However, in this example, the sacral pressure pad 1168 includes a number of slits 1169. The slits 1169 in the sacral pressure pad 1168 can help spread the sacral pressure pad 1168 over the user's sacrum and can aid in removing the sacral pressure pad 1168 from the user. This function can be further enhanced by arranging the slits 1169 at an angle to the longitudinal axis of the sacral pressure pad 1168.

[0069] 12A-12C show another example user interface assembly 1210 including a user interface 1216 and an applicator 1218 as one embodiment of the user interface 116 and the applicator 118. In FIGURES 12A-12C, the user interface 1216 is disposed within a hole 1219 in the applicator 1218 during attachment of the user interface 1216 to a user, and the applicator 1218 and the user interface 1216 are configured to be unattached from one another after attachment of the user interface 1216 to the user.

[0070] In this example, the user interface 1216 defines an aperture 1246 configured to communicate with the lumen of the exhaust conduit 112 described above. As shown in Figure 12B, the user interface 1216 can also include an adhesive sheet 1220 and a release liner 1260 as described above.

[0071] 12A and 12C show the user interface assembly 1210 in a first configuration in which the user interface 1216 fits within the hole 1219 of the applicator 1218. As shown in FIG. 12C, the user interface assembly 1210 is configured to bend and / or fold along an axis extending through the user interface 1216 without uncoupling the user interface 1216 from the applicator 1218. In this first configuration, an operator can couple the user interface 1216 to a user while holding the applicator 1218, similar to that described above.

[0072] 12B shows the user interface assembly 1210 in a second configuration in which the user interface 1216 has been decoupled from the applicator 1218. In one example, the adhesive sheet 1220 can have a first peel force that defines the amount of force required to remove the user interface 1216 from the skin of a user, and the user interface assembly 1210 can have a second peel force that defines the amount of force required to decouple the applicator 1218 from the user interface 1216 along the interface between the applicator 1218 and the user interface 1216 (e.g., around the perimeter of the hole 1219). The first peel force can be greater than the second peel force. In this configuration, once the user interface 1216 is attached to a user's skin, an operator can decouple and remove the applicator 1218 by pulling the applicator 1218 away from the user interface 1216 with a force that is (i) greater than the second peel force and (ii) less than the first peel force.

[0073] 13A and 13B show another example user interface assembly 1310 including a user interface 1316 and an applicator 1318 as one embodiment of the user interface 116 and applicator 118. The user interface assembly 1310 is substantially similar to the user interface assembly 1210 of FIGS. 12A-12C except that the user interface assembly 1310 includes a user interface 1316 having multiple arms extending from a central ring that defines an aperture 1346 that communicates with the lumen of the exhaust conduit 112.

[0074] Similar to the user interface assembly 1210 of FIGS. 12A-12C, the user interface 1316 is disposed within holes 1319 in the applicator 1318 during attachment of the user interface 1316 to a user, and the applicator 1318 and the user interface 1316 are configured to decouple from one another after attachment of the user interface 1316 to a user. However, the user interface assembly 1310 of FIGS. 13A and 13B differs from the user interface assembly 1210 in that, when in the first configuration, the arms of the user interface 1316 extend beyond the holes 1346 and are attached to a distal surface of the applicator 1318. After the adhesive sheet 1320 on the central ring of the user interface 1316 is attached to the skin of the user, the applicator 1318 can be pulled away from the user interface 1316 between the first and second peel forces described above to decouple the applicator 1318 from the user interface 1316. In this example, during decoupling of the applicator 1318 from the user interface 1316 , the arm can pass through a hole 1319 in the applicator 1318 .

[0075] 14-20 show additional views of the applicator 118 shown in FIGS. 6-9G, according to one example.

[0076] 21 illustrates another example of a user interface 2116. The user interface 2116 illustrated in FIG. 21 is substantially similar or identical to the user interface 116 described above, except that the user interface 2116 includes a plurality of adhesive sheets 2120A, 2121B. In particular, the adhesive sheets may include a first adhesive sheet 2120A and a second adhesive sheet 2120B. The first adhesive sheet 2120A is bonded to a proximal surface of the user interface 2116, and the second adhesive sheet 2120B is bonded to a proximal surface of the first adhesive sheet 2120A. As illustrated in FIG. 21, the second adhesive sheet 2120B includes a plurality of holes 2162. In this configuration, the first adhesive sheet 2120A is positioned between the second adhesive sheet 2120B and the user interface 2116, with a portion of the first adhesive sheet 2120A exposed through a hole 2162 in the second adhesive sheet 2120B.

[0077] As shown in FIG. 21, the holes can be distributed throughout the second adhesive sheet 2120B. However, in other examples, holes can be omitted from portions of the second adhesive sheet 2120B. In some examples, the holes can be uniformly distributed throughout one or more portions (or the entirety) of the second adhesive sheet 2120B. Although the holes 2162 are circular in FIG. 21, the holes 2162 can have different shapes (e.g., hexagonal, other polygonal, and / or non-polygonal shapes) in other examples.

[0078] The first adhesive sheet 2120A has a first adhesive strength and the second adhesive sheet 2120B has a second adhesive strength different from the first adhesive strength. This can help control the overall adhesive strength applied to the skin. In one example, the first adhesive strength is greater than the second adhesive strength. In another example, the first adhesive strength is less than the second adhesive strength.

[0079] 22A and 22B, another example embodiment of the collection reservoir 114 is shown. As described above, the collection reservoir 114 can be coupled to a distal end of the discharge conduit 112 (e.g., as shown in FIGS. 2, 5, and 6), and the collection reservoir 114 is configured to contain feces.

[0080] In this example, the collection reservoir 114 comprises a port 2270 and a cap 2272. The port 2270 defines an opening 2274 in the collection reservoir 114 that can receive feces from the drainage conduit 112. The cap 2272 is configured to removably attach to the port 2270 at the opening 2274. In particular, the cap 2272 is operable between (i) an open state in which the cap 2272 is unattached from the port 2270 at the opening 2274 (shown in FIG. 22B ) such that the opening 2274 is not covered by the cap 2272, and (ii) a closed state in which the cap 2272 is attached to the port 2270 at the opening 2274 (shown in FIG. 22A ) such that the opening 2274 is covered by the cap 2272. In this configuration, when the cap 2272 is in an open state, the drain conduit 112 can join the port 2270 and allow feces to pass into the collection reservoir 114, and when the cap 2272 is in a closed state, the cap 2272 can help block or prevent feces from leaking through the opening 2274 of the port 2270.

[0081] 22A and 22B, the cap 2272 is joined to an exterior surface of the port 2270 such that (i) the cap 2272 is movable between an open state and a closed state, and (ii) when the cap 2272 is in the open state, the cap 2272 remains joined to the port 2270. For example, in FIG. 22A and 22B, the cap 2272 is joined to the port 2270 by a connector portion 2276. In one example, the connector portion 2276 can be a living hinge. In another example, the connector portion 2276 can be a leash that extends between the cap 2272 and the port 2270. In some examples, the port 2270, the cap 2272, and the connector portion 2276 can be a monolithic structure. In other examples, one or more of the port 2270, the cap 2272, and the connector portion 2276 can be formed as separate pieces that are later joined together.

[0082] 22A and 22B, the cap 2272 includes a hook 2278. The hook 2278 can be configured to connect the collection reservoir 114 to a support structure (e.g., a hospital bed and / or a wheelchair) while the cap 2272 is in an open state. This can help to hook and support the collection reservoir 114 while the drain tube 112 is connected to the port 2270.

[0083] 23, a flow chart of a process 2300 for using a fecal collection system is shown, according to an example. At block 2310, the process 2300 includes positioning a user interface assembly at a user's anus. The user interface assembly comprises a user interface and an applicator. At block 2312, the process 2300 includes mating the user interface to the skin of the user by pressing the user interface against the skin of the user using the applicator. At block 2314, the process 2300 includes removing the applicator from the user interface after mating the user interface to the skin of the user at block 2312.

[0084] The description of the various advantageous configurations has been presented for purposes of illustration and explanation, and is not intended to be exhaustive or to be limited to the embodiments in the disclosed form. Many modifications and variations will be apparent to those skilled in the art. Moreover, various advantageous embodiments may describe different advantages over other advantageous embodiments. One or more embodiments have been selected and described to explain the principles and practical uses of the embodiments, and to enable those skilled in the art to understand the present disclosure as various embodiments with various modifications as appropriate for the particular use envisioned.

Claims

1. A user interface having a proximal surface and a distal surface, wherein the proximal surface is configured to adhere to the skin of a user, the user interface comprising a first adhesive sheet and a second adhesive sheet, wherein the first adhesive sheet is adhered to the proximal surface of the user interface, the second adhesive sheet is adhered to the proximal surface of the first adhesive sheet, and the second adhesive sheet has a plurality of holes, so that a portion of the first adhesive sheet is exposed through the plurality of holes in the second adhesive sheet; and a user interface assembly comprising an applicator adhered to the distal surface of the user interface and removable from the user interface while the user interface remains adhered to the user, An excretory conduit extending between a proximal end and a distal end, wherein the proximal end is configured to connect to the distal surface of the user interface, and the excretory conduit defines a lumen configured to guide feces from the proximal end to the distal end, A collection reservoir connected to the distal end of the discharge conduit and A fecal collection system equipped with [a specific feature].

2. The fecal collection system according to claim 1, wherein the plurality of adhesive sheets define holes that are aligned axially with the lumen of the discharge conduit.

3. The applicator comprises a first lateral portion, a second lateral portion, and a hinge portion between the first lateral portion and the second lateral portion. The fecal collection system according to claim 1, wherein the first lateral portion and the second lateral portion are configured to move around the hinge portion between an unfolded state and a folded state.

4. The fecal collection system according to claim 3, wherein the applicator further comprises a slit extending along the hinge portion between the first lateral portion and the second lateral portion of the applicator.

5. The fecal collection system according to any one of claims 1 to 4, wherein the plurality of holes are uniformly distributed throughout the second adhesive sheet.

6. The fecal collection system according to any one of claims 1 to 5, wherein the first adhesive sheet has a first adhesive strength, and the second adhesive sheet has a second adhesive strength different from the first adhesive strength.

7. The fecal collection system according to claim 6, wherein the first adhesive strength is greater than the second adhesive strength.

8. The fecal collection system according to claim 6, wherein the first adhesive strength is less than the second adhesive strength.

9. The collection reservoir is A port defining an opening in the collection reservoir, the port through which feces can be received from the discharge conduit, A cap that is removably joined to the port in the opening, wherein the cap is operable between (i) an open state in which the cap is separated from the opening of the port and the opening is not covered by the cap, and (ii) a closed state in which the cap is joined to the port in the opening and the opening is covered by the cap, and the cap is provided with a hook for joining the collection reservoir to a support structure. A fecal collection system according to any one of claims 1 to 8, comprising:

10. The fecal collection system according to claim 9, wherein the cap is joined to the port by a living hinge.

Images