Systems and methods for securing stoma-related devices

Abstract

The systems and the methods disclosed herein provide a device for engaging a tube disposed within a stoma of a subject, the device comprising: a lower assembly configured to abut a surface of a skin adjacent to the stoma; and an upper assembly comprising an internal structure configured to engage at least a portion of the tube disposed within the stoma, wherein the upper assembly is coupled to the lower assembly via a coupling mechanism that permits a movement of the upper assembly relative to the lower assembly along a plane substantially parallel to the surface of the skin.

Description

WSGR Docket No. 70112-701601SYSTEMS AND METHODS FOR SECURING STOMA-RELATED DEVICESCROSS REFERENCE

[0001] This application claims the benefit of U.S. Provisional Application No.63 / 791,291, filed April 18, 2025, and U.S. Provisional Application No. 63 / 755,149, filed February 6, 2025, each of which is incorporated by reference in its entirety for all purposes.BACKGROUND

[0002] A stoma is an opening in the body. For example, a mouth, a nose, and an anus are natural stomata. Hollow organs can be manipulated into artificial stomata. For example, this may include the esophagus, stomach, duodenum, ileum, colon, pleural cavity, ureters, urinary bladder, and renal pelvis. Such a stoma may be permanent or temporary. Some surgical procedures may include the creation of an artificial stoma, which may be referred to as “ostomy” procedures or “ostomies.”SUMMARY

[0003] The present disclosure provides methods and systems for coupling to a stoma-related device that is placed on or adjacent to a stoma of a subject. Advantageously, the methods and the systems disclosed herein may help secure a stoma-related device from the outside environment or tampering (intentional or unintentional), while still maintaining easy access for maintenance and cleaning to improve patient outcome.

[0004] In some aspects, the present disclosure provides a device for engaging a tube disposed within a stoma of a subject, the device comprising: a lower assembly configured to abut a surface of a skin adjacent to the stoma; and an upper assembly comprising an internal structure configured to engage at least a portion of the tube disposed within the stoma, wherein the upper assembly is coupled to the lower assembly via a coupling mechanism that permits a movement of the upper assembly relative to the lower assembly along a plane substantially parallel to the surface of the skin.

[0005] In some aspects, the present disclosure provides a method for engaging a tube disposed within a stoma of a subject, the method comprising: (a) placing a device over a surface of a skin adjacent to the stoma, wherein the device comprises (i) a lower assembly for abutting the surface of the skin and (ii) an upper assembly for engaging at least a portion ofWSGR Docket No. 70112-701601the tube disposed within the stoma; and (b) subsequent to (a), moving the upper assembly relative to the lower assembly along a plane substantially parallel to the surface of the skin.

[0006] In some aspects, the present disclosure provides a kit for engaging a tube disposed within a stoma of a subject, comprising: the device of the preceding aspects; and a cutting tool configured to cut at least a portion of the tube.

[0007] Additional aspects and advantages of the present disclosure will become readily apparent to those skilled in this art from the following detailed description, wherein only illustrative embodiments of the present disclosure are shown and described. As will be realized, the present disclosure is capable of other and different embodiments, and its several details are capable of modifications in various obvious respects, all without departing from the disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.INCORPORATION BY REFERENCE

[0008] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. To the extent publications and patents or patent applications incorporated by reference contradict the disclosure contained in the specification, the specification is intended to supersede and / or take precedence over any such contradictory material.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. In some embodiments, the novel features of the present disclosure are set forth with particularity in the appended claims. In some embodiments, a better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:

[0010] FIG. 1 illustrates an example of a stoma-related tube, specifically a g-tube;

[0011] FIG. 2 illustrates an example of a tic-tac-toe dressing;

[0012] FIGs. 3 A and 3B illustrate examples of a stoma-related securement device;

[0013] FIGs. 4A and 4B illustrate examples of applying a stoma-related securement device over a stomaWSGR Docket No. 70112-701601

[0014] FIGs. 5A and 5B illustrate examples of a stoma-related securement device applied to skin;

[0015] FIGs. 6A and 6B illustrate examples of sliding gauze pad under a stoma-related tube bolster of a stoma-related securement device;

[0016] FIGs. 7A and 7B illustrate examples of a gauze pad fully inserted under a stoma-related tube bolster of a stoma-related securement device;

[0017] FIGs. 8A and 8B illustrate examples of stoma-related securement device with a closed lid;

[0018] FIGs. 9A and 9B illustrate examples of exploded views of a stoma-related securement device;

[0019] FIGs. 10A and 10B illustrate examples of exploded views of a lower assembly of a stoma-related securement device;

[0020] FIGs. 11 A and 1 IB illustrate examples of an upper assembly of a stoma-related securement device;

[0021] FIGs. 12A and 12B illustrate examples of a stoma-related securement device with an open and closed lid;

[0022] FIG. 13 illustrates an example of coupling rings of a stoma-related securement device;

[0023] FIGs. 14A and 14B illustrate examples of rotating the upper assembly of a stoma-related securement device;

[0024] FIGs. 15A and 15B illustrate examples of exploded views of rings of a stoma-related securement device;

[0025] FIG. 16 illustrates an example of connected rings of a stoma-related securement device;

[0026] FIG. 17 illustrates an example of an exploded view of another configuration of rings of a stoma-related securement device;

[0027] FIGs. 18A and 18B illustrate examples of exploded views of locking tab and recess features of a stoma-related securement device;

[0028] FIGs. 19A and 19B illustrate examples of sectional views of locking tab and recess features of a stoma-related securement device;

[0029] FIGs. 20A and 20B illustrate examples of a locking tab deflected while engaging with a recess of a stoma-related securement device;

[0030] FIGs. 21A and 21B illustrate examples of a locking tab engaged with a recess of aWSGR Docket No. 70112-701601stoma-related securement device;

[0031] FIGs. 22A and 22B illustrate examples of a locking tab sliding along an inclined surface of a stoma-related securement device;

[0032] FIGs. 23 A and 23B illustrate examples of locking tabs deflecting until fracture without locking tab stops of a stoma-related securement device;

[0033] FIGs. 24A and 24B illustrate examples of locking tab stops of a stoma-related securement device;

[0034] FIG. 25 illustrates an example of alignment of recess and notches on a lower assembly of a stoma-related securement device;

[0035] FIG. 26 illustrates an example of a locking tab springing down of a stoma-related securement device;

[0036] FIGs. 27A and 27B illustrate examples of inserting a syringe into a balloon port with an open lid of a stoma-related securement device;

[0037] FIGs. 28A and 28B illustrate examples of inserting a syringe into a balloon port with a closed lid of a stoma-related securement device;

[0038] FIGs. 29A and 29B illustrate examples of ventilation holes distributed across a lid of a stoma-related securement device;

[0039] FIGs. 30A and 30B illustrate examples of a lid of a stoma-related securement device without a cap of a stoma-related tube;

[0040] FIG. 31 illustrates an example of a cutting tool to remove the feeding port cap of a stoma-related tube;

[0041] FIG. 32 illustrates an example of a stoma-related tube cutting tool with a face matching a stoma-related tube bolster profile;

[0042] FIG. 33 illustrates an example of a stoma-related tube cutting tool performing a precise cut of a stoma-related tube cap;

[0043] FIG. 34 illustrates an example of a modified stoma-related tube cutting tool;

[0044] FIG. 35 illustrates an example of a curved blade of a modified stoma-related tube cutting tool;

[0045] FIG. 36 illustrates an example of an improved view of a stoma via using a modified stoma-related tube cutting tool to cut a cap and portion of a stoma-related tube;

[0046] FIG. 37 illustrates an example of a comparison showing improved access sliding gauze using a modified stoma-related tube cutting tool;

[0047] FIG. 38 illustrates an example of a comparison showing reduced pressure on aWSGR Docket No. 70112-701601stoma using a modified stoma-related tube cutting tool;

[0048] FIG. 39 illustrates an example of sliding gauze pad under a stoma-related tube bolster of a stoma-related securement device;

[0049] FIG. 40 illustrates an example of a stoma-related tube, specifically a j -tube;

[0050] FIG. 41 illustrates an example of a comparison between a stoma-related securement device for a g-tube in an open configuration and a stoma-related securement device for a j -tube in an open configuration;

[0051] FIG. 42 illustrates an example of a comparison between a stoma-related securement device for a g-tube in a locking configuration and a stoma-related securement device for a j -tube in a locking configuration;

[0052] FIG. 43 illustrates an example of a comparison between an exploded view of a stoma-related securement device for a g-tube and an exploded view of a stoma-related securement device for a j -tube;

[0053] FIG. 44 illustrates an example of a first view of a locking mechanism for a stoma-related securement device for a j -tube;

[0054] FIG. 45 illustrates an example of a second view of a locking mechanism for a stoma-related securement device for a j -tube;

[0055] FIG. 46 illustrates an example of a first view of a child locking mechanism for a stoma-related securement device for a j -tube;

[0056] FIG. 47 illustrates an example of a second view of a child locking mechanism for a stoma-related securement device for a j -tube; and

[0057] FIG. 48 illustrates an example of a flowchart implementing one or more of the systems or the methods disclosed herein.DETAILED DESCRIPTION

[0058] A gastrostomy is a surgical procedure that creates an artificial opening through the stomach and abdominal walls. This allows for the insertion of a gastrostomy tube (g-tube), which helps provide nutrition, fluids, medication, etc. to patients facing challenging in receiving them orally. Over 300 underlying conditions can lead to a patient needing a g-tube, including cancer, neurological disorders, diabetes, gastrointestinal diseases, etc. among the most prominent. These conditions as well as the growing geriatric population are contributing to significant growth in the g-tube market, with projections reaching 5.3 billion by 2031. This makes g-tubes the fastest growing enteral feeding device segment in the US and globally.

[0059] Various aspects of the present disclosure provide systems and methods forWSGR Docket No. 70112-701601securing stoma-related devices. The stoma-related devices disclosed herein may comprise a medical device that is placed on or adjacent to a stoma, e.g., an artificial opening through a skin of a subject and into a hollow portion of an organ. The stoma-related devices may provide, for example, enteral, vesical, or parenteral access to the organ. Non-limiting examples of a stoma-related device can include a gastrostomy tube (g-tube), a gastrojejunostomy tube, a jejunostomy tube (j -tube), a vesicostomy button, a colostomy bag, an ileostomy bag, a urostomy bag, a tracheostomy tube, a suprapubic catheter, an enteral access device (EAD), or similar (e.g., related) devices. Non-limiting examples of applications of ostomy procedures the systems and the methods disclosed herein may be applied to include one or more of appendicostomy, cecostomy, cholecystostomy, choledochotomy, colostomy, dacryocystorhinostomy, duodenostomy, esophagostomy, gastrostomy, ileostomy, jejunostomy, nephrostomy, proctostomy, sclerotomy, tracheostomy, ureterostomy, urostomy, vesicostomy, or similar (e.g., related) procedures.

[0060] The present disclosure provides systems (e.g., a dressing) comprising one or more components that can be at least partially coupled to such stoma-related device that is placed on or adjacent to a stoma of a subject, as well as methods of use thereof.

[0061] The present disclosure provides various embodiments with references to the systems and the methods for securing a gastrostomy tube (or gastrostomy button) and enhancing use thereof. Such embodiments are provided by way of example only and thus can be applied more generally to be compatible with other stoma-related devices as provided herein.Examples of Stoma-Related Tubes

[0062] In some cases, a gastrostomy tube (g-tube) is a low-profile feeding tube that allows for direct delivery of nutrition, hydration, and medication to a patient’s stomach. Unfortunately, there is no device currently on the market that adequately secures and manages stoma-related tubes, while simultaneously allowing complete access to the exit site (without removing the device). This lack of accessibility makes it difficult for caregivers and patients to effectively clean the area, monitor for complications, change gauze, etc. FIG. 1 illustrates an example of a stoma-related tube 100. As illustrated, the stoma-related tube 100 may comprise one or more of a feeding port cap 101, a feeding port 102, an external bolster 103, tubing 104, a balloon port 105, or a balloon 106. While the systems and the methods disclosed herein may be discussed herein with respect to g-tubes, the systems and the methods disclosed herein may be applied, in some cases, to one or more of aWSGR Docket No. 70112-701601gastrojejunostomy tube, a jejunostomy tube (j -tube), a vesicostomy button, a colostomy bag, an ileostomy bag, a urostomy bag, a tracheostomy tube, a suprapubic catheter, an enteral access device (EAD), or similar (e.g., related) devices.

[0063] In some cases, patients and caregivers are taught to dress these stoma-related tubes (e.g., g-tubes) with tape and gauze with what is known as the tic-tac-toe dressing. FIG.2 illustrates an example 200 of a tic-tac-toe dressing 201 of a stoma-related tube 100 (e.g., g-tube) that may be the same as or similar to the stoma-related tube 100 of FIG. 1.

[0064] Unfortunately, the dressing 200 does not adequately stabilize the stoma-related tube, which allows the stoma-related tube to move up and down and side to side in the tract. This constant movement widens the stoma, delays wound healing and leads to a variety of tract-related complications that may last for months to years. These problems include granulation tissue formation, stomal enlargement with leakage, skin breakdown, skin infection, and accidental dislodgement. Accidental dislodgement is particularly problematic — especially in the first six weeks following initial placement of a tube — because a radiologic study is required to confirm proper replacement of the tube into the stomach or bowel. Furthermore, the dressing 200 may need to be replaced several times per day to control leakage from the tract. This process can be very cumbersome and time-consuming for patients and their caregivers and lead to medical adhesive related skin injury from repetitive removal and reapplication of the tape.Examples of Applying Stoma-Related Securement Devices

[0065] The systems and the methods disclosed herein provide a new device to secure and manage stoma-related tubes (g-tubes). FIGs. 3 A and 3B illustrate examples of a stoma-related securement devices 300A and 300B (e.g., g-tube securement device).

[0066] In some cases, the stoma-related securement device 300A / 300B may comprise one or more of: (1) an adhesive faceplate 305 for peristomal attachment, (2) male and female coupling rings 310 to allow rotation of at least a portion of the stoma-related securement device 300A / 300B and the stoma-related tube, (3) an internal structure 315 that engages the stoma-related tube (e.g., at a top portion of the stoma-related tube, such as, the external bolster, near the feeding port cap, etc.), and (4) a protective lid 320 that is coupled to a portion of the stoma-related securement device 300A / 300B via a bi-stable living hinge 325, and (5) a custom gauze pad 330 (or another suitable absorbent member) that fits under the stoma-related tube bolster.

[0067] The stoma-related securement devices 300A / 300B may comprise a cantilever armWSGR Docket No. 70112-701601fixing the internal structure 315 to the coupling rings 310 along the outer border of the stoma-related securement device 300A / 300B. As illustrated, the cantilever of the stoma-related securement device 300A is aligned with the rear of the stoma-related securement device 300A such that the cantilever is substantially aligned with the hinges 325 of the lid. The cantilever of the stoma-related securement device 300B is aligned with the side of the rear of the stoma-related securement device 300B such that the cantilever is about 90° rotated off the rear of the stoma-related securement device 300B. However, in other cases, the cantilever may be rotated off the rear of the stoma-related securement device by a different amount, such as about: 0°, 15°, 30°, 45°, 60°, 75°, 90°, 105°, 120°, 135°, 150°, 165°, 180°, 195°, 210°, 225°, 240°, 255°, 270°, 285°, 300°, 315°, 330°, 345°, 360°, etc. Note that in other figures with an “A” and a “B” (e.g., FIGs. 4A and 4B, FIGs. 5A and 5B, FIGs. 6A and 6B, FIGs. 7A and 7B, etc.), the “A” figure will continue to refer to a stoma-related securement device with a cantilever substantially aligned with the hinges of the lid and the “B” figure will continue to refer to a stoma-related securement device with the cantilever on the side of the stoma-related securement device, as in, rotated about 90° off the rear of the stoma-related securement device. Conversely, figures without an “A” and a “B” (e.g., FIGs. 13, 16, 17, 25, etc.) provide illustrations that may, depending on context, be applicable to stoma-related securement devices having the cantilever in any position (e.g., rear, side, front, etc.).

[0068] In some cases, one or more components of the stoma-related securement devices 300A / 300B may comprise a non-flexible material (e.g., non-resiliently-flexible material). For example, such material may include plastic. In another example, such material may include one or more of glass, metal, ceramic, plant-based, etc. materials. In some cases, substantially all of the stoma-related securement devices 300A / 300B may comprise a non-flexible material (e.g., non-resiliently-flexible material). In some cases, the hinge 325 and the gauze pad 330 may be some of the few (if not the only) flexible materials of the stoma-related securement devices 300A / 300B. In some cases, in addition or alternative to the hinge 325 and the gauze pad 330, one or more other components of the stoma-related securement devices 300A / 300B may comprise a flexible material, such as, rubber, polymer, etc.

[0069] FIGs. 4A-8A and 4B-8B provide a process to apply the stoma-related securement device (e.g., the stoma-related securement device 300A / 300B) to skin 150 a subject to secure a stoma-related tube 100 (which may be the same as or similar to the stoma-related tube 100 ofFIG. 1).

[0070] FIGs. 4A and 4B illustrate examples of applying a stoma-related securementWSGR Docket No. 70112-701601device over a stoma-related tube. Specifically, FIGs. 4A / 4B illustrate an operation 400A / 400B of using the lid (which may be the same as or similar to the lid 320) as a handle, lowering the lid down over the stoma-related tube. The operation 400A / 400B demonstrates positioning the stoma-related securement device over the stoma-related tube, lining up the black line on the stoma-related securement device with the black line of the stoma-related tube (see operation 400B, specifically), then lowering the stoma-related securement device over the stoma-related tube.

[0071] While FIGs. 4A and 4B illustrate the lid as being removable or openable via a hinged motion, in some cases, a stoma-related securement device of the methods and the systems disclosed herein may be removable or openable via a different mechanism. For example, the lid may be removable via a rotational mechanism, such as a continuous thread (screw-on, similar to a water-bottle lid), a lug (twist-off) with short interrupted ridges (enabling a partial turn, e.g., a 90° turn or less, similar to a pickle jar), a bayonet mount with a pin-and-slot mechanism (lid pushed down to compress a spring or gasket and then twisted to lock a pin into an “L” shaped slot, similar to a child-safety medicine bottle or camera lens cap), etc. In another example, the lid may be removeable via a linear friction (push-pull) mechanism, such as a snap-fit (bead-and-undercut) mechanism having a small ridge and lid to snap into the corresponding groove (similar to Tupperware), a plug (stopper) mechanism in which the lid is inserted into an opening and is secured using friction or compression (similar to wine corks or flask stoppers), a telescoping (slip lid) mechanism in which the lid locks in place via a tight tolerance using air pressure and friction (similar to a tea tin), etc. In another example, the lid may be removable via a sliding (shear) mechanism, such as a track and groove in which the lid slides along rails (similar to a wooden domino box), a slide-lock mechanism having a mechanical slide that disengages a lock (similar to a travel mug or mint tin), etc. In another example, the lid may be removed using a leverage or prying mechanism, such as a crimped (crown cap) in which a flexible skirt is crimped to secure the lid (similar to a pie tin or a bottle cap), a lever-ring in which the lid is held by friction (similar to a paint can), etc. In another example, the lid may be removed in a destructive (e.g., single use) mechanism, such as a ring-pull (stay-on-tab) in which the lid is pushed in or pulled back using a riveted ring (similar to a soda can), a peel seal in which the lid is induction-sealed (similar to a yogurt cup), etc.

[0072] FIGs. 5A and 5B illustrate examples of a stoma-related securement device applied to skin. Specifically, FIGs. 5A / 5B illustrate an operation 500A / 500B of how, once fullyWSGR Docket No. 70112-701601applied, the adhesive faceplate 505 (which may be the same as or similar to the adhesive faceplate 305) will keep the stoma-related securement device adhered to the peristomal skin.

[0073] FIGs. 6A and 6B illustrate examples of sliding a gauze pad (which may be the same as or similar to the gauze pad 330) under a stoma-related tube bolster of a stoma-related securement device. Specifically, FIGs. 6A / 6B / illustrate an operation 600A / 600B of sliding the gauze under the stoma-related tube to control leakage.

[0074] FIGs. 7A and 7B illustrate examples of a gauze pad (which may be the same as or similar to the gauze pad 330) fully inserted under a stoma-related tube bolster of a stoma-related securement device. Specifically, FIGs. 7A / 7B illustrate an operation 700A / 700B of making sure gauze is pushed-in substantially all the way.

[0075] FIGs. 8A and 8B illustrate examples of stoma-related securement device with a closed lid (which may be the same as or similar to the lid 320). Specifically, FIGs. 8A / 8B illustrate an operation 800A / 800B of closing the lid to fully secure the stoma-related tube. As illustrated, with the lid closed, the gauze pad (or another suitable absorbent member) may not be visible or accessible to the outside of the stoma-related securement device. However, in other cases, the gauze pad may at least partially extend beyond the dimensions of the stoma-related securement device or lid.Examples of Structures of Stoma-Related Securement Devices

[0076] FIGs. 9A and 9B illustrate examples of exploded views of a stoma-related securement device 900A and 900B (which may be the same as or similar to the stoma-related securement device 300A / 300B). As illustrated, the stoma-related securement device 900 A and 900B comprises a lower assembly 940, an upper assembly 935, and a gauze pad 930. The gauze pad may be the same as or similar to the gauze pad 330. While illustrated as detachable, in some cases, the upper assembly 935 and the lower assembly 940 may not be detachable from each other, e.g., instead using a single assembly (rotating or not rotating).

[0077] In some cases, the upper assembly 935 and the lower assembly 940 may be coupled via a coupling mechanism. For example, the coupling mechanism may include a guide and rail assembly. For example, the guide may be integrated into the upper assembly 935 or the lower assembly 940 and the rail integrated into the other one of the upper assembly 935 and the lower assembly 940. Furthermore, as illustrated, the guide and rail assembly is a curvilinear guide and rail assembly (e.g., given the curved profile of the stoma-related securement device). Specifically, as illustrated, the curvilinear guide and rail assembly is substantially circular (e.g., given the substantially circular profile of the stoma-relatedWSGR Docket No. 70112-701601securement device).

[0078] In some cases, the gauze pad 930 comprises a slit configured to engage at least partially around the stoma-related tube. For example, the slit may engage with the stoma-related tube around at least about: 45°, 90°, 135°, 180°, 225°, 270°, 315°, 360°, etc. In some cases, the slit may be positioned along a center-axis of the gauze 930, as illustrated in FIG. 9A. While in other cases, the slit may be positioned off the center-axis of the gauze 930, as illustrated in FIG. 9B.

[0079] FIGs. 10A and 10B illustrate examples of exploded views of a lower assembly 1000A and 1000B, which may be the same as or similar to the lower assembly 940, of a stoma-related securement device. The lower assembly 1000A / 1000B comprises a semiflexible plastic coupling ring 1012 (which may be the same as or similar to the male coupling ring of the female and male coupling rings 310) bonded to an adhesive faceplate 1005 (which may be the same as or similar to adhesive faceplate 305). The underside of the adhesive faceplate 1005 comprises a long-wearing adhesive to secure the entire device to the peristomal skin surface. For example, the adhesive may be configured to adhere to skin for about 1 day, about 3 days, about 5 days, about 1 week, about 10 days, about 2 weeks, about 3 weeks, about one months, about 6 weeks, about 2 months, about 3 months, etc. In some cases, in addition or in alternative to using an adhesive, the stoma-related securement device may be secured to the skin of a patient by some other means (e.g., a strap, Velcro, magnets, hooks, stitches, etc.). The backside of the adhesive faceplate 1005 may comprise a breathable, nonwoven fabric that is bonded to the plastic coupling ring 1012 using medical grade pressure sensitive adhesive (PSA) or medical grade cyanoacrylate.

[0080] FIGs. 11 A and 1 IB illustrate examples of an upper assembly 1100A and 1100B (which may be the same as or similar to the upper assembly 935) of a stoma-related securement device. The upper assembly 1100A / 1100B comprises a lid 1120 (which may be the same as or similar to the lid 320), a bi-stable living hinge 1125 (which may be the same as or similar to the bi-stable living hinge 325), an internal structure 1115 (which may be the same as or similar to the internal structure 315), a female coupling ring 1114 (which may be the same as or similar to the female coupling ring of the female and male coupling rings 310), and a silicone stoma-related tube cap 1150 (e.g., a g-tube cap).

[0081] FIGs. 12A and 12B illustrate examples of a stoma-related securement device 1200 A and 1200B (which may be the same as or similar to the stoma-related securement device 300A / 300B) in an open position (lid open) and a closed position (lid closed). In someWSGR Docket No. 70112-701601cases, as illustrated, the lid of the stoma-related securement device 1200A / 1200B can be coupled to the female coupling ring or the internal structure via one or more living hinges. A living hinge can operate by bending of the hinge structure itself, rather than by using an additional mechanical hinge mechanism such as a ball and joint hinge. The living hinge can be a continuous portion, such that at least a portion of the lid and at least a portion of the female coupling ring or the internal structure can be a single continuous piece (e.g., not two separate pieces held together via a mechanical hinge mechanism). The living hinge can comprise one or more degrees of freedom (e.g., 1, 2, 3, 4, 5, or 6 degrees of freedom). For example, the living hinge can comprise a bispecific living hinge having one degree of freedom (e.g., roll, pitch, or yaw) to permit (e.g., only permit) opening and closing of the lid 1200A / 1200B relative to the female coupling ring. However, in other cases, the stoma-related securement device 1200A / 1200B may use a non-living hinge, such as a hinge with an additional hinge mechanism, such as one or more of: an adjustable hinge, a ball and joint hinge, a butt hinge, a concealed hinge, a continuous hinge, a comer hinge, a double-acting hinge, a drop hinge, a fixed hinge, a piano hinge, a pivot hinge, a quick release hinge, a selfclosing hinge, a spring hinge, a strap hinge, a T-hinge, a torque hinge, a variable geometry hinge, etc.

[0082] In some cases, the internal structure may be as shown in the figures provided herein. In some cases, the internal structure may comprise additional components (e.g., additional extensions along one or more axes) that are configured to hold (e.g., grab, pinch, etc.) at least a portion of the stoma-related tube (e.g., at least a portion of the upper top portion of the stoma-related tube). In some cases, in production, the upper assembly1100A / 1100B and lower assembly 1000A / 1000B are mated together via the male and female coupling rings.Examples of Rotating Stoma-Related Securement Devices

[0083] FIG. 13 illustrates an example 1300 of coupling rings of a stoma-related securement device (which may be the same as or similar to the female and male coupling rings 310) during assembly. As illustrated, assembly may be achieved via a coupling mechanism, such as a guide and rail assembly. For example, the guide and rail assembly illustrated provides that the coupling rings are mated together via an annular snap-fit joint, a specific type of mechanical connection where a ring-shaped component (the female coupling ring) expands when pushed onto a complementary ring-shaped component (the male coupling ring) and then returns to normal shape once the coupling rings are coupled. This creates aWSGR Docket No. 70112-701601secure fit relying on hoop stress to keep the parts together. Specifically, the example 1300 (lower portion) shows a sectional view illustrating the parts in a coupled condition. Also shown in the example 1300 (upper portion) is an enlarged exploded view illustrating the female ring expanding during the coupling process. In other cases, the coupling rings may be mated together via other means, e.g., a screw-on configuration, a snapping together, magnetic means, adhesive means, a locking mechanism, or the like. In some cases, another rotation mechanism may be implemented, e.g., ball bearings, rod-axel, etc.

[0084] In some cases, the annular snap-fit illustrated in FIG. 13 is designed to have a clearance fit — or slip fit — a type of fit between two parts that allows for some space between them so that the parts can move freely. In this case, this may allow transverse, rotational movement of the two rings. That is, the two rings can revolve around a vertical axis independently of each other, while still remaining coupled (in the same plane).

[0085] When the stoma-related securement device is applied to the skin, the lower male ring may become fixed. This allows the entire upper assembly (which may be the same as or similar to the upper assembly 1100A / 1100B) to swivel like a revolving turntable.Importantly, since the inner structure of the upper assembly engages the external bolster of the stoma-related tube and ensures that the entire device is positioned concentrically around the stoma-related tube, the act of spinning the upper assembly also spins the stoma-related tube. FIGs. 14A and 14B illustrate examples 1400 A and 1400B of rotating the upper assembly of a stoma-related securement device.

[0086] As illustrated, the upper assembly rotates substantially parallel (or parallel) to a surface of the skin of the patient. Because the surface of the skin of the user may be rounded (or otherwise non-planar), substantially parallel rotation with respect to the surface of the skin of the patient may include substantially parallel to an axis that is substantially tangent to a point on the surface of the skin of the user. For example, this point may be on or near the stoma corresponding to the stoma-related tube. In some cases, the upper assembly may rotate substantially parallel to a coupling plane that lies along the coupling of the upper assembly and the lower assembly. Furthermore, substantially parallel to a surface of the skin (or the axis tangent to the point, or the coupling plane, etc.) may include parallel to within about: 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 15°, 20°, 25°, 30°, etc. in one or more dimensions.Furthermore, as illustrated, a rotational axis of the rotational movement may be substantially perpendicular to the surface of the skin (or the axis tangent to the point, or the coupling plane, etc.). Substantially perpendicular may include perpendicular to within about: 1°, 2°, 3°, 4°,WSGR Docket No. 70112-7016015°, 6°, 7°, 8°, 9°, 10°, 15°, 20°, 25°, 30°, etc. in one or more dimensions.

[0087] In some cases, the upper assembly (e.g., including the lid) may not rotate. In some cases, the upper assembly (e.g., including the lid) may rotate independently of the stoma-related tube (e.g., the g-tube 100). Alternatively, in some cases, rotation of the upper assembly (e.g., including the lid) may induce rotation of the stoma-related tube (e.g., the g-tube 100). For example, the induced rotation may be about one-to-one (as in one degree of rotation of the upper assembly may induce about one degree of rotation of the stoma-related tube). In another example, the induced rotation may not be about one-to-one (as in one degree of rotation of the upper assembly may induce more than or less than about one degree of rotation of the stoma-related tube).

[0088] In some cases, the systems and the methods disclosed herein provides for rotating the upper assembly (which may be the same as or similar to the upper assembly1100A / 1100B) in controlled 90° increments. This function is achieved by the inner wall of the female ring having a downward protruding tab located at every 90° while the lower male ring has a corresponding notch at every 90° to receive the tab. FIGs. 15A and 15B illustrate examples 1500A and 1500B of exploded views of rings of a stoma-related securement device, showing how notches may be positioned at about every 90° (although, in some cases, the notches may be positioned at other increments, e.g., at about every 1°, 5°, 10°, 15°, 45°, 60°, 120°, 180°, etc.).

[0089] In some cases, when notches 1560 and tabs 1562 of FIGs. 15A and 15B are in alignment, both coupling rings may be in an unstressed state, and the upper assembly (which may be the same as or similar to the upper assembly 1100A / 1100B) may resist rotation. However, when the user begins to rotate the upper assembly, the inner wall of the female ring may be forced to deform upward slightly and may remain deformed until the user spins the upper assembly a full 90°, at which point the notch 1560 and tab 1562 will line up again, allowing the two rings to “snap” back into their unstressed state. This snapping action refers to the rings quickly returning to their unstressed state, creating a snapping — or clicking — sound, which provides audible and tactile feedback to the user that they successfully turned the device 90°. FIG. 16 illustrates an example 1600 of connected rings of a stoma-related securement device. Specifically, the example 1600 provides a sectional view of the two coupling rings, illustrating the deformation that occurs when tabs 1662 and notches 1660 are out-of-alignment versus when in-alignment.

[0090] While, in some cases, favorable performance is achieved when the notches 1660WSGR Docket No. 70112-701601and tabs 1662 are located on the inner wall of the rings and with the tabs on the female ring and the notches on the male ring, various other embodiments can achieve the same or similar function. As an example, FIG. 17 illustrates an example of an exploded view of another configuration of rings of a stoma-related securement device, where tabs 1762 and notches 1760 are on the outside wall, with the tabs 1762 on the male ring and the notches 1760 on the female ring. While FIG. 17 illustrates the notches 1760 above the tabs 1762, in some cases, the relative positioning may be flipped, with the notches 1760 positioned below the tabs 1762.

[0091] In some cases, the upper assembly (which may be the same as or similar to the upper assembly 1100A / 1100B) and the lower assembly (which may be the same as or similar to the lower assembly 1000A / 1000B) may be configured to rotate relative to one another by at least about: 1 degree, 5 degrees, 10 degrees, 15 degrees, 18 degrees, 20 degrees, 30 degrees, 36 degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, 105 degrees, 120 degrees, 150 degrees, 180 degrees, 210 degrees, 240 degrees, 270 degrees, 300 degrees, 330 degrees, or 360 degrees, or at most about 360 degrees, 330 degrees, 300 degrees, 270 degrees, 240 degrees, 210 degrees, 180 degrees, 150 degrees, 120 degrees, 105 degrees, 90 degrees, 75 degrees, 60 degrees, 45 degrees, 36 degrees, 30 degrees, 20 degrees, 18 degrees, 15 degrees, 10 degrees, 5 degrees, 1 degree, etc. Such relative rotation between the upper assembly and the lower assembly can be uni-directional (e.g., clockwise or counterclockwise) or bi-directional (e.g., clockwise and counter-clockwise). The stoma-related device (e.g., stoma-related tube) that is coupled to the upper assembly may move (e.g., within the stoma) along with the upper assembly during the relative movement between the upper assembly and the lower assembly.

[0092] In some cases, the upper assembly and the lower assembly can comprise one or more coupling mechanisms (e.g., tab and notch) to control a degree of the relative rotation between the two pieces. The upper assembly and the lower assembly can comprise a plurality of coupling mechanisms (e.g., a plurality of identical coupling mechanisms) that are crosscompatible. For example, one of the upper assembly and the lower assembly can comprise multiple female coupling units (e.g., notches) and the other of the upper assembly and the lower assembly can comprise multiple male coupling units (e.g., tabs), and each of the multiple female coupling units can be compatible with each of the multiple male coupling units, e.g., to permit a continuous relative rotation between the two assemblies. The upper assembly and the lower assembly can comprise one or more (e.g., at least 1, 2, 3, 4, 5, 6, 7, 8,WSGR Docket No. 70112-7016019, 10, 11, 12, or more, or at most 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1) pairs of such femalemale coupling units. The upper assembly and the lower assembly can comprise a plurality of pairs of the female-male coupling units that are located at about every: 1 degree, 5 degrees, 10 degrees, 15 degrees, 18 degrees, 20 degrees, 30 degrees, 36 degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, 105 degrees, 120 degrees, 150 degrees, 180 degrees, 270 degrees, 360 degrees, etc.Examples of Tamper-Resistant Lids of Stoma-Related Securement Devices

[0093] In some cases, the systems and the methods disclosed herein provide a tamperresistant or child-resistant lid. Essentially, this is a lid (which may be the same as or similar to the lid 320) that requires a certain level of knowledge to open, thereby reducing the risk of an infant, child, or medically-complex patient inadvertently opening the lid and getting access to the stoma-related tube. A built-in mechanism allows the user to lock the lid by simply rotating the lid (e.g., counterclockwise) until the lid clicks into place, signaling to the user that the lid is locked. In some cases, this mechanism is only engaged when the lid is turned in a certain direction (e.g., counterclockwise), preserving full 360° rotation (e.g., in 90° increments) when spinning the lid in the other direction (e.g., clockwise).

[0094] Several elements of the design may work together to achieve this locking function. First, there may be two (or another suitable number, e.g., one, three, four, five, six, etc.) locking tabs located on the underside of the lid that are spaced 90° apart (or another suitable separation, e.g., about 45°, about 135°, about 180°, etc.) which correspond to complimentary recesses located on the lower assembly also spaced 90° apart (or another suitable separation). FIGs. 18A and 18B illustrate examples 1800A andl800B of exploded views of locking tab and recess features of a stoma-related securement device (which may be the same as or similar to the stoma-related securement device 300A / 300B). Specifically, the examples 1800A / 1800B show locking tabs 1866 and recesses 1864 in an exploded view with the upper assembly (which may be the same as or similar to the upper assembly1100A / 1100B) and the lower assembly (which may be the same as or similar to the lower assembly 1000A / 1000B) uncoupled. FIGs. 19A and 19B illustrate examples 1900A and 1900B of sectional views of a locking tab 1966 (which may be the same as or similar to the locking tab 1866) and recess features of a stoma-related securement device (which may be the same as or similar to the stoma-related securement device 300A / 300B). Specifically, the examples 1900A and 1900B show a sectional view of the stoma-related securement device assembled with the upper assembly and the lower assembly coupled.WSGR Docket No. 70112-701601

[0095] In some cases, as a lid 1920 (which may be the same as or similar to the lid 320) is turned counterclockwise (or clockwise), the locking tab 1966 will catch the recess overhang (the ceiling of the recess compartment). Due to an inclined face (e.g., at about 45°), the locking tab 1966 will be forced to deflect slightly downward as it engages the recess. FIGs.20A and 20B illustrate examples 2000A and 2000B of a locking tab deflected while engaging with a recess of a stoma-related securement device (which may be the same as or similar to the stoma-related securement device 300A / 300B) due to rotation of a lid 2020 (which may be the same as or similar to the lid 320). In some cases, once fully engaged, the locking tab will snap back to its nondeformed state, successfully interlocking the upper assembly (which may be the same as or similar to the upper assembly 1100A / 1100B) and the lower assembly (which may be the same as or similar to the lower assembly 1000A / 1000B) together.

[0096] FIGs. 21A and 21B illustrate examples of a locking tab 2166 (which may be the same as or similar to the locking tab 1866) engaged with a recess (which may be the same as or similar to recess 1864) of a stoma-related securement device (which may be the same as or similar to stoma-related securement device 300A / 300B). In some cases, with the locking tab 2166 and recess structures interlocked, a lid 2120 (which may be the same as or similar to the lid 320) can be opened by rotating it in the reverse direction (e.g., clockwise) until the user hears another clicking sound, which is created by the tab clearing the recess overhang and snapping back into its normal shape. While FIGs. 21 A and 21B illustrate the locking process on one side of the lid, the same process may be occurring simultaneously on the other side with a symmetrical tab and recess to provide additional holding power.

[0097] In some cases, it may be important that the locking mechanism does not impede the ability to rotate the lid 360° in the certain direction (while also clicking into position at 90° increments). To preserve this functionality, the bottom of the locking tab may be configured to slide along an inclined surface of the lower assembly. This inclined surface serves two purposes. First, it raises the locking tab so that it can clear the top of the next recess structure. Second, it does so gradually enough that the user does not feel the sensation of the locking tab being raised. For the stoma-related securement device to be intuitive, the lid may provide one clicking sensation at every 90°. If the tab were to be suddenly raised to overcome the recess geometry and spring back, this may result in the user sensing two clicks — one right before 90° and another at exactly 90°, which may make it more difficult to determine when the lid has turned a full 90°. FIGs. 22A and 22B illustrate examples 2200A and of a locking tab 2266 (which may be the same as or similar to the locking tab 1866)WSGR Docket No. 70112-701601sliding along an inclined surface of a stoma-related securement device (which may be the same as or similar to the stoma-related securement device 300A / 300B) via rotation of a lid 2220 (which may be the same as or similar to the lid 320).

[0098] In some cases, the ability of the locking tabs (e.g., the locking tabs 1866) to flex upward also plays an important role. If the locking tabs were not able to flex, the inclined surface of the lower assembly (which may be the same as or similar to the lower assembly 1000A / 1000B) may raise the entire lid at every 90° interval instead of just the locking tabs. This force may be strong enough to overcome the snap-fit closure resulting in the lid and upper ring becoming decoupled every time the user spins the device clockwise (or counterclockwise). Moreover, the locking tabs may tend to return to their unflexed position, which is lower than the inclined surface (see FIGs. 19A and 19B). This may help ensure the tip of the locking tab catches the edge of the recess overhang when rotating the lid counterclockwise (or clockwise). Furthermore, while it may be important that the locking tabs are able to deflect upward, it may also be important that the locking tabs do not deflect downward as this may lead to failure of the locking mechanism. FIGs. 23 A and 23B illustrate examples of a locking tab 2366 (which may be the same as or similar to the locking ab 1866) deflecting until fracture without locking tab stops of a stoma-related securement device (which may be the same as or similar to the stoma-related securement device 300A / 300B), thereby demonstrating what could happen if the locking tab 2366 was not prevented from deflecting downward. For example, the locking tab 2366 may eventually deflect to the point of fracture, resulting in failure of the locking mechanism.

[0099] This design presents unique challenges — such as creating a tab that may be free to deflect upward, but resist deflecting downward. To accomplish this, a tab stop 2468 platform may be included to prevent the locking tab from deflecting downward. For example, see FIGs. 24A and 24B, which illustrate examples 2400A and 2400B of locking tab stops 2468 of a stoma-related securement device (which may be the same as or similar to the stoma-related securement device 300A / 300B).

[0100] It is also important to note how the recesses and notches in the lower assembly are aligned at a certain interval (e.g., every 90°, as illustrated) such as, in FIG. 25, which illustrates an example 2500 of alignment of recess and notches on a lower assembly of a stoma-related securement device (which may be the same as or similar to the stoma-related securement device 300A / 300B). In some cases, because the lid and female coupling ring are part of the same assembly (e.g., upper assembly), rotating the lid rotates the entire assembly,WSGR Docket No. 70112-701601female coupling ring included. Therefore, the moment the locking tab passes the top edge of the inclined surface, the locking tab may spring back to its unstressed shape — creating a snapping sound — which may coincide with the notch and tab features snapping into place as well (e.g., as discussed with respect to controlled rotation above). Having these two processes take place simultaneously helps to ensure the user feels and hears only one “click”.

[0101] FIG. 26 illustrates an example of a locking tab springing down of a stoma-related securement device (which may be the same as or similar to the stoma-related securement device 300A / 300B). This design may seem redundant, but not when considering that the lid may not always be closed when rotating the upper assembly. For example, when the lid is open, the notch and tab mechanism still ensures the upper assembly can click into place at every 90° turn. For example, this may be useful when cleaning around the stoma, in which case ,the lid may be in the open position. To clean under the stoma-related tube, the user can rotate the upper assembly to access underneath the stoma-related tube. The stoma-related tube having the ability to click into position at every 90° turn prevents the lid from spinning freely, which may be irritating (e.g., to the patient or care provider) when trying to clean the stoma.Examples of Balloon Port Access for Stoma-Related Securement Devices

[0102] In some cases, the systems and the methods disclosed herein provide convenient access to the balloon port valve whether a lid of a stoma-related securement device (which may be the same as or similar to the stoma-related securement device 300A / 300B) is open or closed. This is accomplished via several design advantages. First, the height and diameter of the coupling rings of the stoma-related securement device may be large enough to allow gauze (or another suitable absorbent member) to slip in between the inner structure and upper ring, but small enough to not obstruct a syringe from horizontally accessing the balloon port, as shown in FIGs. 27A and 27B, which illustrate examples 2700A and 2700B of inserting a syringe into a balloon port with an open lid of a stoma-related securement device (which may be the same as or similar to the stoma-related securement device 300A / 300B). Accordingly, the stoma-related securement device may provide accessibility for a syringe to couple for inflating a balloon.

[0103] In some cases, the design of the systems and the methods disclosed herein also has an aperture on the front of the lid that allows a syringe to be inserted while the lid is closed. This provides the benefit of full securement while checking the balloon volume, as shown in FIGs. 28A and 28B, which illustrate examples 2800A and 2800B of inserting a syringe into aWSGR Docket No. 70112-701601balloon port access 2870 with a closed lid of a stoma-related securement device (which may be the same as or similar to the stoma-related securement device 300A / 300B).Examples of Ventilation for Stoma-Related Securement Devices

[0104] It may be advantageous to keep the stoma-related region (e.g., a gastrostomy region) as dry as possible. The systems and the methods disclosed herein provide ventilation, such as enhanced or optimal ventilation. This is achieved by distributing small openings across the lid, which will help with breathability, without compromising structural integrity. In some cases, the openings may be distributed substantially uniformly (e.g., with radial uniformity, with linear uniformity, etc.). In some cases, the openings may be distributed non-uniformly (e.g., according to some other approach or technique). FIGs. 29A and 29B illustrate examples of openings 2975 distributed across a lid of a stoma-related securement device (which may be the same as or similar to the stoma-related securement device 300A / 300B).

[0105] In some cases, the lid of the stoma-related securement device illustrated in FIGs.29A / 29B can comprise the one or more openings 2975. The one or more openings 2975 can comprise one or more holes, aperture(s), grille(s), louver(s), slot(s), slit(s), aperture(s), or combinations thereof. The one or more openings 2975 can permit ventilation of air through a space within the lid, e.g., a space in fluid communication with the skin adjacent to the stoma, the stoma-related device such as the gastrostomy device, the female coupling ring, the internal structure, the gauze pad, or combinations thereof. The one or more openings 2975 can be disposed within a sub-region (e.g., not distributed throughout) of a surface of the lid. Alternatively, the one or more openings 2975 can be disposed throughout the surface of the lid, e.g., uniformly or non-uniformly. The one or more openings 2975 can comprise a first opening and a second opening that are disposed on substantially opposite sides relative to a central dimension (e.g., point, axis, line, plane, etc.) of the lid. For example, a lid having a dome shape can comprise (i) one or more first openings 2975 disposed on one side of a central arc of the dome (e.g., left side or front side) and (ii) one or more second openings 2975 disposed on the opposite side of the central arch of the dome (e.g., right side or back side, respectively). The one or more openings 2975 can comprise a single opening. The one or openings 2975 can comprise a plurality of openings, such as at least about 2, 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 100, or more openings, and / or at most about 100, 90, 80, 70, 60, 50, 40, 30, 20, 15, 10, 5, or 2 openings. In some cases, the profile of the lid may have a surface area that has about 1% removed for openings, about 5% removed for openings, aboutWSGR Docket No. 70112-70160110% removed for openings, about 20% removed for openings, about 30% removed for openings, etc.

[0106] In some cases, the stoma-related securement device may not have openings for ventilation. In some cases, the openings for ventilation may be located, in addition or in alternative to on the lid, in another location on the stoma-related securement device.

[0107] In some cases, the one or more openings 2975 of the stoma-related securement device illustrated in FIGs. 29A / 29B may be configured to allow forced air to enter the stoma-related securement device. For example, the air may be forced in via a fan, a pressure differential, a pump, etc. that may be compatible with the stoma-related securement device, openings 2975Examples of Modifying Stoma-Related Tube Caps for Stoma-Related Securement Devices

[0108] In some cases, the systems and the methods disclosed herein provide compatibility for the stoma-related securement device securing a stoma-related tube with a cap or without a cap. For example, some stoma-related tubes are capless, such as, the Avanos new MIC -KEY stoma-related tube, called the Evolve. Other than being a bit smaller, the biggest difference is that the Evolve may include a feeding port mechanism that does not need a feeding port cap.

[0109] Advantageously, the systems and the methods disclosed herein provide a stoma-related securement device that it is compatible with both the current MIC -KEY stoma-related tube and other capped stoma-related tubes and can also be easily adapted to fit the new Evolve and other capless stoma-related tubes. To accomplish this, the systems and the methods disclosed herein may provide for snipping the stoma-related tube cap and then retrofitting the lid of the stoma-related securement device to include a feeding port cap. This way, once the new capless stoma-related tubes (e.g., Evolve) becomes available, the stoma-related securement device (which may be the same as or similar to the stoma-related securement device 300A / 300B) will maintain compatibility (e.g., with scaling the stoma-related securement device down to fit the new size and removing the feeding port cap). FIGs.30A and 30B illustrate examples of a lid of a stoma-related securement device 3000 A and 3000B (which may be the same as or similar to the stoma-related securement device 300A / 300B) without a cap of a stoma-related tube.

[0110] In some cases, to facilitate snipping the feeding port cap, a safe and user-friendly tool may be used that allows for cutting the cap without the use of scissors. FIG. 31 illustrates an example 3100 of a cutting tool 3180 to cut the feeding port cap of a stoma-related tube.WSGR Docket No. 70112-701601

[0111] In some cases, the cutting tool 3180 also helps provide a precise cut every time, reducing likelihood of fitment issues when applying the device over the stoma-related tube. The face of the cutting tool 3180 is shaped to mirror (or be similar to) the external profile of the stoma-related tube bolster, as shown in FIG. 32, which illustrates an example 3200 of a stoma-related tube cutting tool with a face matching a stoma-related tube bolster profile. This allows the user to slide the cutting tool up from the rear until flush with the stoma-related tube. Once flush, the protected blade of the cutting tool may be lined up and the user can safely snip the feeding port cap, as shown in FIG. 33, which illustrates an example 3300 of a stoma-related tube cutting tool performing a precise cut of a stoma-related tube cap.

[0112] Another option, in some cases, is to snip the stoma-related tube further up, removing not only the feeding port cap, but also a portion of the rear bolster, as shown in FIG. 34, which illustrates an example 3400 of a modified cutting tool. As illustrated, example 3400 shows a modified version with a curved blade positioned closer to the feeding port. The curved blade provides a cleaner cut so that the resulting edge follows the same curvature of the central portion of the stoma-related tube, as shown in FIG. 35, which illustrates an example of a curved blade of a modified cutting tool.

[0113] The design of the modified cutting tool has several potential benefits. First, it provides more visibility to the stoma, which makes it easier to monitor the site for infection or granulation tissue, as shown in FIG. 36, which illustrates an example of an improved view of a stoma via using the modified stoma-related tube cutting tool to cut a cap and portion of a stoma-related tube. Further, the design simplifies the process of applying the gauze (or another suitable absorbent member) under the stoma-related tube, as there is less stoma-related tube to slide under, and therefore, fewer opportunities for the gauze to catch on the rear bolster when sliding in, as show in FIG. 37, which illustrates an example of a comparison 3700 showing improved access sliding gauze using a modified stoma-related tube cutting tool. Still further, this design has the potential to redistribute some of the pressure applied directly on top of the stoma, to instead, the surrounding skin. After some time, the patient can begin to develop a pressure wound from the external bolster resting directly on top of the skin, as shown in FIG. 38, which illustrates an example of a comparison 3800 showing reduced pressure on a stoma using a modified stoma-related tube cutting tool. By removing a portion of the external bolster, there is less mass applying pressure to the stoma.

[0114] Another modification that has benefits is relocating the hinge for the lid to theWSGR Docket No. 70112-701601same side as the cantilevered internal structure. This may improve ergonomics, especially when sliding in the gauze. Because this process may include grasping the gauze on either side, having the lid on the opposing end helps keep the lid out of the way of both hands as shown in FIG. 39, which illustrates an example 3900 of sliding gauze pad under a stoma-related tube bolster of a stoma-related securement device, which is a variation upon the examples 600 A and 600B of FIGs. 6 A and 6B.Additional Examples of Stoma-Related Securement Devices

[0115] As disclosed herein, in some cases, the methods and the systems disclosed herein may be applied to one or more of: a gastrostomy tube (g-tube), a gastrojejunostomy tube, a jejunostomy tube (j -tube), a vesicostomy button, a colostomy bag, an ileostomy bag, a urostomy bag, a tracheostomy tube, a suprapubic catheter, an enteral access device (EAD), or similar (e.g., related) devices. Non-limiting examples of applications of ostomy procedures the systems and the methods disclosed herein may be applied to include one or more of appendicostomy, cecostomy, cholecystostomy, choledochotomy, colostomy, dacryocystorhinostomy, duodenostomy, esophagostomy, gastrostomy, ileostomy, jejunostomy, nephrostomy, proctostomy, sclerotomy, tracheostomy, ureterostomy, urostomy, vesicostomy, or similar (e.g., related) procedures.

[0116] FIG. 40 illustrates an example of a stoma-related tube 4000, specifically a j -tube, for which the methods and the systems disclosed herein may be applicable to. As illustrated, the stoma-related tube 4000 may include one or more of: a feeding port cover 4001, a feeding port 4002, a feed head or bolster 4003, a balloon port 4004, a balloon 4005, or tubing 4006. For example, a stoma-related securement device that may be the same as or similar to the stoma-related securement device 300A / 300B may be applied to the j-tube 4000. In some cases, both the g-tube 100 and the j-tube 4000 may serve similar functions, but may be placed in different regions of the digestive track. For example, the g-tube 100 may be placed in the stomach, while the j-tube 4000 may be place in the jejunum.

[0117] In some cases, the stoma-related securement device 300A / 300B may be modified in one or more respects to be used with a j-tube (e.g., instead of a g-tube or other stoma-related securement devices). For example, FIG. 41 illustrates an example of a comparison 4100 between a stoma-related securement device for a g-tube in an open configuration and a stoma-related securement device for a j-tube in an open configuration. As illustrated, in an open configuration, the stoma-related securement devices of the comparison 4100 both have their respective lids open.WSGR Docket No. 70112-701601

[0118] In some cases, a stoma-related securement device configured for a j -tube may have certain differences from a stoma-related securement device for a g-tube. In one example, a stoma-related securement device configured for a j -tube may not rotate (or rotate less), while a stoma-related securement device for a g-tube may rotate (such as freely, e.g., for 360°). In another example, a stoma-related securement device configured for a j-tube may not rotate when the lid is open, while a stoma-related securement device for a g-tube may rotate whether the lid is open or closed. In another example, a stoma-related securement device configured for a j-tube may include a child-locking feature such that when the lid is closed the lid can only rotate a small amount (e.g., about 7°) in a first direction (e.g., counterclockwise), while a stoma-related securement device for a g-tube may include a childlocking feature such that the lid locks when the lid is rotated in a first direction (e.g., counterclockwise) and the lid can be opened after rotating in a second direction (e.g., clockwise) until a “click” occurs (e.g., after about 90°). Such differences may be illustrated in FIG. 42, which illustrates an example of a comparison 4200 between a stoma-related securement device for a g-tube in a locking configuration and a stoma-related securement device for a j-tube in a locking configuration.

[0119] FIG. 43 also illustrates examples of differences between a stoma-related securement device for a g-tube and a stoma-related securement device for a j-tube.Specifically, FIG. 43 illustrates an example of a comparison 4300 between an exploded view of a stoma-related securement device for a g-tube and an exploded view of a stoma-related securement device for a j-tube. As illustrated, both the stoma-related securement device for the g-tube and for the j-tube comprise locking recesses 4364 (which may be the same as or similar to the locking recesses 1864), and tabs 4366 (which may be the same as or similar to the tabs 1866). Specifically, while the stoma-related securement device for the g-tube may comprise four (or another suitable number, e.g., one, two, three, five, six, etc.) locking recesses 4364, the stoma-related securement device for the j-tube may comprise two (or another suitable number, e.g., one, three, four, five, six, etc.) locking recesses 4364.Furthermore, the locking of the locking recesses 4364 and the tabs 4366 of the stoma-related securement device for the j-tube may be released by closing of a lid of the stoma-related securement device, through, for example, a lid depressor 4367.

[0120] As disclosed herein, in some cases, a lid of a stoma-related securement device for a j-tube may not rotate when the lid is in the open position. FIG. 44 illustrates an example of a first view 4400 of a locking mechanism for a stoma-related securement device for a j-tube.WSGR Docket No. 70112-701601As illustrated, the locking mechanism includes tabs 4466 (which may be the same as or similar to the tabs 4366) proximate to the hinge of the lid. The tabs may prevent rotation of the lid when the lid is open. Furthermore, FIG. 45 illustrates an example of a second view 4500 of a locking mechanism for a stoma-related securement device for a j -tube. As illustrated, as the lid is closed, the lid depresses the tabs of FIG. 44 via a lid depressor 4567 (which may be the same as or similar to the lid depressor 4367) to enable rotation. In some cases, the enabled rotation may be in one direction (e.g., clockwise or counterclockwise). In some cases, the enabled rotation may be in both directions. In some cases, the enabled rotation may be limited, such as, to a relatively small amount. For example, this relatively small rotation may be about: 1°, 3°, 5°, 7°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 60°, etc. In other cases, the enabled rotation may be in a larger amount (e.g., about 75°, about 90°, about 120°, about 150°, about 180°, about 270°, about 360°, etc.). In some cases, the enabled rotation may be a free rotation (as in unlimited rotation). In some cases, the enabled rotation may be limited, such as, no more than about: 90°, 180°, 270°, 360°, 450°, 540°, 630°, 720°, 1080°, 1440°, 1800°, 2160°, 2520°, 2880°, 3240°, 3600°, etc.

[0121] In some cases, the methods and the systems disclosed herein may provide a childlocking mechanism for a stoma-related securement device. For example, the child-locking mechanism may be applicable to a stoma-related securement device for a j -tube. FIG. 46 illustrates an example of a first view 4600 of a child locking mechanism for a stoma-related securement device for a j -tube. As illustrated, the child-locking mechanism may engage via rotation in one direction (e.g., counterclockwise). Further, to engage the child-locking mechanism the rotation may be a relatively small amount. For example, this relatively small rotation may be about: 1°, 3°, 5°, 7°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 60°, etc.Alternatively, the enabled rotation may be in a larger amount (e.g., about 75°, about 90°, about 120°, about 150°, about 180°, about 270°, about 360°, etc.). FIG. 47 illustrates an example of a second view 4700 of a child locking mechanism for a stoma-related securement device for a j -tube. As illustrated, the stoma-related securement device of the second view 4700 may include a tab 4766 (which may be the same as or similar to the tab 4366) to control rotation of the lid. For example, the tab 4766 may ensure the lid can only rotate in one direction (e.g., counterclockwise).Examples of Methods for Stoma-Related Tube Securement

[0122] FIG. 48 illustrates an example of a flowchart 4800 implementing one or more of the systems or the methods disclosed herein. At a high level, the flowchart 4800 includes:WSGR Docket No. 70112-701601placing a device over a surface of a skin adjacent to a stoma of a subject, wherein the device comprises (i) a lower assembly for abutting the surface of the skin and (ii) an upper assembly for engaging at least a portion of the tube disposed within the stoma (block 4805); and moving the upper assembly relative to the lower assembly along a plane substantially parallel to the surface of the skin (block 4810).

[0123] In some cases, the flowchart 4800 may further include covering at least a portion of the surface of the skin via closing a lid of the device (block 4815; not illustrated). In some cases, the flowchart 4800 may further include placing an absorbent member (i) above at least a portion of the lower module assembly and (ii) at least partially around the tube (block 4820; not illustrated).

[0124] In some cases, one or more operations of the flowcharts 4800 may be performed in any order. Further, at least one of the one or more operations disclosed above with respect to the flowchart 4800 may be repeated, e.g., iteratively.Certain Definitions and Additional Considerations

[0125] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0126] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0127] Whenever the term “at least,” “greater than,” or “greater than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “at least,” “greater than” or “greater than or equal to” applies to each of the numerical values in that series of numerical values. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0128] Whenever the term “no more than,” “less than,” or “less than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “no more than,” “less than,” or “less than or equal to” applies to each of the numerical values in that series of numerical values. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0129] Certain inventive embodiments herein contemplate numerical ranges. When ranges are present, the ranges include the range endpoints. Additionally, every sub range and value within the range is present as if explicitly written out.

[0130] The term “about” or “approximately” may mean within an acceptable error range for the particular value, which will depend in part on how the value is measured orWSGR Docket No. 70112-701601determined, e.g., the limitations of the measurement system. For example, “about” may mean within 1 or more than 1 standard deviation, per the practice in the art. Alternatively, “about” may mean a range of up to 20%, up to 10%, up to 5%, or up to 1% of a given value. Where particular values are described in the application and claims, unless otherwise stated the term “about” meaning within an acceptable error range for the particular value may be assumed.

[0131] As used herein, “or” is intended to mean an “inclusive or” or what is also known as a “logical OR,” wherein when used as a logic statement, the expression “A or B” is true if either A or B is true, or if both A and B are true, and when used as a list of elements, the expression “A, B or C” is intended to include all combinations of the elements recited in the expression, for example, any of the elements selected from the group consisting of A, B, C, (A, B), (A, C), (B, C), and (A, B, C); and so on if additional elements are listed. As such, any reference to “or” herein is intended to encompass “and / or” unless otherwise stated.

[0132] It will be understood that when an element such as a layer, region, or substrate is referred to as being “on” or extending “onto” another element, it may be directly on or extend directly onto the other element or intervening elements may also be present. In contrast, when an element is referred to as being “directly on” or extending “directly onto” another element, there are no intervening elements present. Likewise, it will be understood that when an element such as a layer, region, or substrate is referred to as being “over” or extending “over” another element, it may be directly over or extend directly over the other element or intervening elements may also be present. In contrast, when an element is referred to as being “directly over” or extending “directly over” another element, there are no intervening elements present. It will also be understood that when an element is referred to as being “connected” or “coupled” to another element, it may be directly connected or coupled to the other element or intervening elements may be present. In contrast, when an element is referred to as being “directly connected” or “directly coupled” to another element, there are no intervening elements present.

[0133] Relative terms such as “below” or “above” or “upper” or “lower” or “horizontal” or “vertical” may be used herein to describe a relationship of one element, layer, or region to another element, layer, or region as illustrated in the Figures. It will be understood that these terms and those discussed above are intended to encompass different orientations of the device in addition to the orientation depicted in the Figures.

[0134] It will be understood that, although the terms “first,” “second,” “third,” etc. may be used herein to describe various elements, these elements should not be limited by theseWSGR Docket No. 70112-701601terms. These terms are only used to distinguish one element from another. For example, a first element may be termed a second element, and, similarly, a second element may be termed a first element, without departing from the scope of the present disclosure.

[0135] Where values are described as ranges, it will be understood that such disclosure includes the disclosure of all possible sub-ranges within such ranges, as well as specific numerical values that fall within such ranges irrespective of whether a specific numerical value or specific sub-range is expressly stated.

[0136] As used herein, like characters refer to like elements.

[0137] While preferred embodiments of the present invention have been shown and disclosed herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention disclosed herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

[0138] It should be noted that various illustrative or suggested ranges set forth herein are specific to their example embodiments and are not intended to limit the scope or range of disclosed technologies, but, again, merely provide example ranges for frequency, amplitudes, etc. associated with their respective embodiments or use cases. Where values are described as ranges, it will be understood that such disclosure includes the disclosure of all possible subranges within such ranges, as well as specific numerical values that fall within such ranges irrespective of whether a specific numerical value or specific sub-range is expressly stated.

[0139] It should be understood that, unless a term is expressly defined in this patent, there is no intent to limit the meaning of that term, either expressly or by implication, beyond its plain or ordinary meaning, and such term should not be interpreted to be limited in scope based at least in part on any statement made in any section of this patent (other than the language of the claims). To the extent that any term recited in the claims at the end of this patent is referred to in this patent in a manner consistent with a single meaning, that is done for sake of clarity only so as to not confuse the reader, and it is not intended that such claim term be limited, by implication or otherwise, to that single meaning.

[0140] Throughout this specification, plural instances may implement components, operations, or structures described as a single instance. Although individual operations of oneWSGR Docket No. 70112-701601or more methods are illustrated and described as separate operations, one or more of the individual operations may be performed concurrently, and nothing requires that the operations be performed in the order illustrated. Structures and functionality presented as separate components in example configurations may be implemented as a combined structure or component. Similarly, structures and functionality presented as a single component may be implemented as separate components. These and other variations, modifications, additions, and improvements fall within the scope of the subject matter herein.EMBODIMENTS

[0141] The following non-limiting embodiments provide illustrative examples of the present disclosure, but do not limit the scope of the present disclosure.

[0142] Embodiment 1. A device for engaging a tube disposed within a stoma of a subject, the device comprising: a lower assembly configured to abut a surface of a skin adjacent to the stoma; and an upper assembly comprising an internal structure configured to engage at least a portion of the tube disposed within the stoma, wherein the upper assembly is coupled to the lower assembly via a coupling mechanism that permits a movement of the upper assembly relative to the lower assembly along a plane substantially parallel to the surface of the skin, optionally wherein:(1) the upper assembly is rotatably coupled to the lower assembly, wherein the movement comprises a rotational movement; and / or(2) a rotational axis of the rotational movement is substantially perpendicular to the plane; and / or(3) the movement of the upper assembly is independent from a movement of the tube; and / or(4) the movement of the upper assembly induces a movement of at least a portion of the tube along the plane; and / or(5) the coupling mechanism is part of the lower assembly, the upper assembly, or both; and / or(6) the coupling mechanism comprises a guide and rail assembly; and / or(7) the coupling mechanism comprises a curvilinear guide and rail assembly; and / or (8) the curvilinear guide is substantially circular; and / or(9) further comprising: a lid for covering at least a portion of the surface of the skin;and / or(10) the lid is coupled to the upper assembly via a hinge configured to permit pivotal movement of the lid relative to the upper assembly; and / orWSGR Docket No. 70112-701601(11) the hinge comprises a living hinge; and / or(12) the device further comprises a locking mechanism configured to lock the lid in a closed position relative to the lower assembly; and / or(13) the locking mechanism comprises a tab and a recess; and / or(14) the lid comprises one or more openings for ventilation; and / or(15) the device further comprises an absorbent member configured to be placed (i) above at least a portion of the lower module assembly and (ii) at least partially around the tube; and / or(16) the absorbent member comprises a slit configured to engage at least partially around the tube; and / or(17) the slit is positioned off a center-axis of the absorbent member(18) one or both of the lower assembly or the upper assembly are substantially circular in profile; and / or(19) the upper assembly comprises an outer border, and wherein the internal structure is disposed interior to the outer border; and / or(20) the internal structure is fixed to the outer border; and / or(21) the internal structure is configured to engage a top portion of the tube; and / or (22) the internal structure is configured to reversibly engage the at least the portion of the tube; and / or(23) the tube is an enteral feeding tube; and / or(24) the enteral feeding tube comprises a gastrostomy tube; and / or(25) the enteral feeding tube comprises a jejunostomy tube; and / or(26) the lower assembly comprises an adhesive for engaging the surface of the skin;and / or(27) the lower assembly comprises a shape that surrounds an outer perimeter of the stoma; and / or(28) the internal structure is not resiliently flexible; and / or(29) the at least the portion of the tube comprises an orifice.

[0143] Embodiment 2. A method for engaging a tube disposed within a stoma of a subject, the method comprising: (a) placing a device over a surface of a skin adjacent to the stoma, wherein the device comprises (i) a lower assembly for abutting the surface of the skin and (ii) an upper assembly for engaging at least a portion of the tube disposed within the stoma; and (b) subsequent to (a), moving the upper assembly relative to the lower assembly along a plane substantially parallel to the surface of the skin,WSGR Docket No. 70112-701601optionally wherein:(1) the moving in (b) comprises a rotational movement; and / or(2) a rotational axis of the rotational movement is substantially perpendicular to the plane; and / or(3) the moving in (b) of the upper assembly is independent from a movement of the tube; and / or(4) the moving in (b) of the upper assembly induces a movement of the tube; and / or (5) the upper assembly is coupled to the lower assembly via a coupling mechanism that permits movement, wherein the coupling mechanism is part of the lower assembly, the upper assembly, or both; and / or(6) the coupling mechanism comprises a guide and rail assembly; and / or(7) the coupling mechanism comprises a curvilinear guide and rail assembly; and / or (8) the curvilinear guide is substantially circular; and / or(9) the method further comprises (c) covering at least a portion of the surface of the skin via closing a lid of the device; and / or(10) the lid is coupled to the upper assembly via a hinge configured to permit pivotal movement of the lid relative to the upper assembly; and / or(11) the hinge comprises a living hinge; and / or(12) the moving in (b) locks the lid in a closed position relative to the lower assembly; and / or(13) the lid is locked via a locking mechanism comprising a tab and a recess; and / or (14) the lid comprises one or more openings for ventilation; and / or(15) the method further comprises (d) placing an absorbent member (i) above at least a portion of the lower module assembly and (ii) at least partially around the tube; and / or(16) the absorbent member comprises a slit configured to engage at least partially around the tube; and / or(17) the slit is positioned off a center-axis of the absorbent member(18) one or both of the lower assembly or the upper assembly are substantially circular in profile; and / or(19) the upper assembly comprises an outer border, and wherein an internal structure that engages at least a portion of the tube disposed within the stoma is disposed interior to the outer border; and / or(20) the internal structure is fixed to the outer border; and / orWSGR Docket No. 70112-701601(21) the internal structure engages a top portion of the tube; and / or(22) the internal structure reversibly engages the at least the portion of the tube; and / or(23) the internal structure is not resiliently flexible; and / or(24) the tube is an enteral feeding tube; and / or(25) the enteral feeding tube comprises a gastrostomy tube; and / or(26) the enteral feeding tube comprises a jejunostomy tube; and / or(27) the lower assembly comprises an adhesive for engaging the surface of the skin;and / or(28) the lower assembly comprises a shape that surrounds an outer perimeter of the stoma; and / or(29) the at least the portion of the tube comprises an orifice; and / or(30) the method further comprises (e) cutting a cap of the tube on a distal end of the tube outside the subject.

[0144] Embodiment 3. A kit for engaging a tube disposed within a stoma of a subject, comprising: the device of Embodiment 1; and a cutting tool configured to cut at least a portion of the tube,optionally wherein: a(1) the at least the portion of the tube is a cap on a distal end of the tube outside the subject; and / or(2) the kit further comprises instructions that instruct a user to cut the at least the portion of the tube; and / or(3) the kit further comprises instructions that instruct the user to engage the absorbent member at least partially around the tube while the lid is in an open position relative to the lower assembly.

Claims

WSGR Docket No. 70112-701601CLAIMS WHAT IS CLAIMED IS:

1. A device for engaging a tube disposed within a stoma of a subject, the device comprising:a lower assembly configured to abut a surface of a skin adjacent to the stoma; and an upper assembly comprising an internal structure configured to engage at least a portion of the tube disposed within the stoma,wherein the upper assembly is coupled to the lower assembly via a coupling mechanism that permits a movement of the upper assembly relative to the lower assembly along a plane substantially parallel to the surface of the skin.

2. The device of claim 1, wherein the upper assembly is rotatably coupled to the lower assembly, wherein the movement comprises a rotational movement.

3. The device of claim 2, wherein a rotational axis of the rotational movement is substantially perpendicular to the plane.

4. The device of any one of the claims 1-3, wherein the movement of the upper assembly is independent from a movement of the tube.

5. The device of any one of claims 1-3, wherein the movement of the upper assembly induces a movement of at least a portion of the tube along the plane.

6. The device of any one of the preceding claims, wherein the coupling mechanism is part of the lower assembly, the upper assembly, or both.

7. The device of any one of the preceding claims, wherein the coupling mechanism comprises a guide and rail assembly.

8. The device of claim 7, wherein the coupling mechanism comprises a curvilinear guide and rail assembly.

9. The device of claim 8, wherein the curvilinear guide is substantially circular.WSGR Docket No. 70112-70160110. The device of any one of the preceding claims, further comprising: a lid for covering at least a portion of the surface of the skin.

11. The device of claim 10, wherein the lid is coupled to the upper assembly via a hinge configured to permit pivotal movement of the lid relative to the upper assembly.

12. The device of claim 11, wherein the hinge comprises a living hinge.

13. The device of any one of claims 10-12, further comprising a locking mechanism configured to lock the lid in a closed position relative to the lower assembly.

14. The device of claim 13, wherein the locking mechanism comprises a tab and a recess.

15. The device of any one of claims 10-14, wherein the lid comprises one or more openings for ventilation.

16. The device of any one of the preceding claims, further comprising: an absorbent member configured to be placed (i) above at least a portion of the lower module assembly and (ii) at least partially around the tube.

17. The device of claim 16, wherein the absorbent member comprises a slit configured to engage at least partially around the tube.

18. The device of claim 17, wherein the slit is positioned off a center-axis of the absorbent member.

19. The device of any one of the preceding claims, wherein one or both of the lower assembly or the upper assembly are substantially circular in profile.

20. The device of any one of the preceding claims, wherein the upper assembly comprises an outer border, and wherein the internal structure is disposed interior to the outer border.WSGR Docket No. 70112-70160121. The device of claim 20, wherein the internal structure is fixed to the outer border.

22. The device of any one of the preceding claims, wherein the internal structure is configured to engage a top portion of the tube.

23. The device of any one of the preceding claims, wherein the internal structure is configured to reversibly engage the at least the portion of the tube.

24. The device of any one of the preceding claims, wherein the tube is an enteral feeding tube.

25. The device of claim 24, wherein the enteral feeding tube comprises a gastrostomy tube.

26. The device of claim 24, wherein the enteral feeding tube comprises a jejunostomy tube.

27. The device of any one of the preceding claims, wherein the lower assembly comprises an adhesive for engaging the surface of the skin.

28. The device of any one of the preceding claims, wherein the lower assembly comprises a shape that surrounds an outer perimeter of the stoma.

29. The device of any one of the preceding claims, wherein the internal structure is not resiliently flexible.

30. The device of any one of the preceding claims, wherein the at least the portion of the tube comprises an orifice.

31. A method for engaging a tube disposed within a stoma of a subject, the method comprising:WSGR Docket No. 70112-701601(a) placing a device over a surface of a skin adjacent to the stoma, wherein the device comprises (i) a lower assembly for abutting the surface of the skin and (ii) an upper assembly for engaging at least a portion of the tube disposed within the stoma; and(b) subsequent to (a), moving the upper assembly relative to the lower assembly along a plane substantially parallel to the surface of the skin.

32. The method of claim 31, wherein the moving in (b) comprises a rotational movement.

33. The method of claim 32, wherein a rotational axis of the rotational movement is substantially perpendicular to the plane.

34. The method of any one of claims 31-33, wherein the moving in (b) of the upper assembly is independent from a movement of the tube.

35. The method of any one of claims 31-33, wherein the moving in (b) of the upper assembly induces a movement of the tube.

36. The method of any one of claims 31-35, wherein the upper assembly is coupled to the lower assembly via a coupling mechanism that permits movement, wherein the coupling mechanism is part of the lower assembly, the upper assembly, or both.

37. The method of claim 36, wherein the coupling mechanism comprises a guide and rail assembly.

38. The method of claim 37, wherein the coupling mechanism comprises a curvilinear guide and rail assembly.

39. The method of claim 38, wherein the curvilinear guide is substantially circular.

40. The method of any one of claims 31-39, further comprising:(c) covering at least a portion of the surface of the skin via closing a lid of the device.WSGR Docket No. 70112-70160141. The method of claim 40, wherein the lid is coupled to the upper assembly via a hinge configured to permit pivotal movement of the lid relative to the upper assembly.

42. The method of claim 41, wherein the hinge comprises a living hinge.

43. The method of any one of claims 40-42, wherein the moving in (b) locks the lid in a closed position relative to the lower assembly.

44. The method of claim 43, wherein the lid is locked via a locking mechanism comprising a tab and a recess.

45. The method of any one of claims 40-44, wherein the lid comprises one or more openings for ventilation.

46. The method of any one of claims 31-45, further comprising:(d) placing an absorbent member (i) above at least a portion of the lower module assembly and (ii) at least partially around the tube.

47. The method of claim 46, wherein the absorbent member comprises a slit configured to engage at least partially around the tube.

48. The method of claim 47, wherein the slit is positioned off a center-axis of the absorbent member.

49. The method of any one of claims 31-48, wherein one or both of the lower assembly or the upper assembly are substantially circular in profile.

50. The method of any one of claims 31-49, wherein the upper assembly comprises an outer border, and wherein an internal structure that engages at least a portion of the tube disposed within the stoma is disposed interior to the outer border.

51. The method of claim 50, wherein the internal structure is fixed to the outer border.WSGR Docket No. 70112-70160152. The method of any one of claims 50 or 51, wherein the internal structure engages a top portion of the tube.

53. The method of any one of claims 50-52, wherein the internal structure reversibly engages the at least the portion of the tube.

54. The method of any one of claims 50-53, wherein the internal structure is not resiliently flexible.

55. The method of any one of claims 31-53, wherein the tube is an enteral feeding tube.

56. The method of claim 55, wherein the enteral feeding tube comprises a gastrostomy tube.

57. The method of claim 54, wherein the enteral feeding tube comprises a jejunostomy tube.

58. The method of any one of claims 31-57, wherein the lower assembly comprises an adhesive for engaging the surface of the skin.

59. The method of any one of claims 31-58, wherein the lower assembly comprises a shape that surrounds an outer perimeter of the stoma.

60. The method of any one of claims 31-59, wherein the at least the portion of the tube comprises an orifice.

61. The method of any one of claims 31-60, further comprising:(e) cutting a cap of the tube on a distal end of the tube outside the subject.

62. A kit for engaging a tube disposed within a stoma of a subject, comprising:the device of any one of claims 1-30; anda cutting tool configured to cut at least a portion of the tube.WSGR Docket No. 70112-70160163. The kit of claim 62, wherein the at least the portion of the tube is a cap on a distal end of the tube outside the subject.

64. The kit of claim 62 or 63, further comprising:instructions that instruct a user to cut the at least the portion of the tube.

65. The kit of any one of claims 62-64, further comprising:instructions that instruct the user to engage the absorbent member at least partially around the tube while the lid is in an open position relative to the lower assembly.

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