Ostomy port systems and methods of use
Customizable ostomy port systems address the limitations of traditional ostomy bags by offering a secure, reusable, and discreet solution for managing waste, enhancing comfort and hygiene while allowing for flexible use without continuous bag reliance.
Patent Information
- Application Number
- PCT/US2024/034382
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-06-16
- Filing Date
- 2024-06-17
- Publication Date
- 2024-12-19
AI Technical Summary
Existing ostomy management systems, such as bags, face issues like leakage, skin irritation, discomfort, and limited lifestyle flexibility due to their cumbersome nature, leading to a need for improved solutions that enhance comfort, hygiene, and discretion.
Customizable, reusable ostomy port systems comprising a flexible wafer and a detachable base with a lid, designed for secure sealing around the stoma, allowing for temporary adhesion to the skin and optional connection to external waste collection members, with features like pressure sensors for evacuation notification.
The ostomy port system reduces leakage and skin irritation, provides enhanced comfort and hygiene, and allows for more discreet and flexible management of waste, enabling users to bypass the need for continuous bag use during certain activities.
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Figure US2024034382_19122024_PF_FP_ABST
Abstract
Description
OSTOMY PORT SYSTEMS AND METHODS OF USECROSS-REFERENCE TO RELATED APPLICATION(S)[0001| The present application claims the benefit of priority to U.S. Provisional Application No. 63 / 521,505, filed June 16, 2023, which is incorporated by reference herein in its entirety.TECHNICAL FIELD
[0002] The present technology relates to ostomy ports.BACKGROUND
[0003] Ostomies are surgical procedures that create an artificial opening in the abdomen, known as a stoma, to allow the diversion of waste (urine or feces) from a damaged or diseased portion of the urinary or digestive system. The waste exits the body through the stoma and is collected in an external pouch, commonly referred to as an ostomy bag. Ostomy surgery may be necessitated by a variety of medical conditions and circumstances that impair the normal function of the digestive or urinary systems. Common reasons for ostomy surgery include colorectal cancer, which can require removal of portions of the colon or rectum, and inflammatory bowel diseases such as Crohn's disease and ulcerative colitis, which can cause severe damage to the intestines. Other causes include diverticulitis, traumatic injuries or complications from previous surgeries, and congenital defects. These conditions may result in the inability to pass waste normally, necessitating the creation of an alternative pathway through an ostomy.
[0004] Existing solutions for managing ostomies primarily involve the use of ostomy bags, which adhere to the skin around the stoma and securely contain the waste. Despite their widespread use and effectiveness in providing a non-invasive means for waste collection, these bags present several challenges and limitations. One significant drawback is the potential for leakage, which can lead to skin irritation and infection around the stoma site. Additionally, the bags can be cumbersome and noticeable under clothing, affecting the user's confidence and quality of life. They also require frequent changing and emptying, which can be inconvenient and lead to unpleasant odors. Furthermore, ostomy bags may restrict certain physical activities and limit the user'slifestyle choices. These issues highlight the need for improved solutions that enhance the comfort, hygiene, and discretion of ostomy management systems.SUMMARY
[0005] The present technology relates to ostomy port systems and associated systems and methods. Some embodiments of the present technology, for example, are directed to customizable, reusable ostomy ports that obviate the need for users to wear an ostomy bag for hours at a time. The subject technology is illustrated, for example, according to various aspects described below, including with reference to FIGS. 1A-8E. Various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology.1. An ostomy port, comprising: a flexible wafer configured to be positioned on a user’s skin around and in sealing engagement with a stoma, the wafer defining a first opening configured to receive the stoma; a base configured to be detachably coupled to the wafer, the base defining a second opening and configured to be positioned on the wafer such that the first and second openings are aligned; and a lid coupled to the base, wherein the lid is configured to move between a closed position in which the lid covers the second opening and prevents waste from flowing therethrough, and an open position in which the lid remains coupled to the base but is moved away from the second opening such that waste can flow from the stoma through the port.2. The ostomy port of Example 1, wherein the wafer is custom fit to the user’s stoma.3. The ostomy port of Example 1 or Example 2, wherein the cross-sectional shape of the first opening, a cross-sectional dimension of the first opening, a size of the wafer, and / or a shape of the wafer are customized to the user’s stoma.4. The ostomy port of any one of Examples 1 to 3, wherein the wafer is configured to be adhered to the user’s skin via an adhesive.5. The ostomy port of any one of Examples 1 to 4, wherein the portion of the wafer defining the first opening is configured to form a seal around the circumference of the stoma.6. The ostomy port of any one of Examples 1 to 5, wherein the wafer is reusable.7. The ostomy port of any one of Examples 1 to 6, wherein the wafer includes a connector configured to be detachably coupled to an external waste collection member and / or waste guidance member.8. The ostomy port of any one of Examples 1 to 7, wherein the base is custom fit to the user’ s stoma.9. The ostomy port of any one of Examples 1 to 8, wherein a cross-sectional shape of the second opening, a cross-sectional dimension of the second opening, a cross-sectional dimension of the base, a height of the base, and / or a shape of the base are customized to the user’s stoma.10. The ostomy port of any one of Examples 1 to 9, wherein the base includes a connector configured to be detachably coupled to an external waste collection member and / or waste guidance member.11. The ostomy port of any one of Examples 1 to 10, wherein a back side of the base includes a groove and a front side of the wafer includes a complementary projection configured to fit within the groove, thereby securing and forming a seal between the wafer and the base.12. The ostomy port of any one of Examples 1 to 11, wherein the lid is coupled to the base at a hinge and is configured to rotate about the hinge between the open and closed positions.13. The ostomy port of Example 12, wherein the lid is configured to rotate up to 180 degrees between the closed and fully open positions.14. The ostomy port of any one of Examples 1 to 13, wherein the lid is slidably coupled to the base.15. The ostomy port of any one of Examples 1 to 14, wherein no portion of the ostomy port extends into the stoma and / or below the user’s skin.16. The ostomy port of any one of Examples 1 to 15, wherein no portion of the ostomy port is surgically adhered or otherwise implanted into the user.17. The ostomy port of any one of Examples 1 to 16, further comprising a membrane having a first end coupled to the base and a second end coupled to the lid, wherein the membrane is in a collapsed state when the lid is in the closed position and an extended state when the lid is in the open position.18. The ostomy port of Example 17, wherein the membrane borders and extends away from less than a full diameter of the base such that the membrane provides bottom and lateral sidewalls to guide waste exiting the stoma while a top side of the base remains open, thereby providing the user access to an inner surface of the membrane.19. The ostomy port of any one of Examples 1 to 18, further comprising a pressure sensor for sensing pressure within a space enclosed by the stoma, wafer, base, and lid.20. The ostomy port of Example 19, wherein the ostomy port is further configured to notify a user when evacuation of the ostomy port is recommended based on pressure data obtained by the pressure sensor.21. An ostomy port system comprising:a flexible wafer configured to be positioned on a user’s skin around and in sealing engagement with a stoma, the wafer defining a first opening configured to receive the stoma; and a port configured to be detachably coupled to the wafer, the port comprising: a base defining a second opening; and a lid coupled to the base, wherein the lid is configured to move between a closed position in which the lid covers the second opening and prevents waste from flowing therethrough, and an open position in which the lid remains coupled to the base but is moved away from the second opening such that waste can flow from the stoma through the port, wherein no portion of the port extends into the stoma and / or below the user’s skin.22. The ostomy port system of Example 21, further comprising an adhesive element provided separate from the wafer and having a top side configured to be adhered to a front surface of the wafer and a back side configured to be adhered to the user’s skin.23. The ostomy port system of Example 21 or Example 22, wherein the adhesive element is custom fit to the user’s stoma.24. The ostomy port system of any one of Examples 21 to 23, wherein a cross-sectional shape of the adhesive element, a cross-sectional dimension of an opening in the adhesive element, and / or a cross-sectional dimension of the adhesive element are customized to the user’s stoma.25. The ostomy port system of any one of Examples 21 to 24, further comprising a waste collection bag configured to be coupled to the port and configured to receive waste evacuated from the stoma through the port.26. The ostomy port system of any one of Examples 1 to 25, further comprising a waste chute configured to be coupled to the port and configured to receive waste evacuated from the stoma through the port.27. A method of using an ostomy port, comprising: securing a wafer to a user’ s skin around a stoma; securing a port to the wafer, the port comprising: a base defining an opening; and a lid coupled to the base, wherein the lid is configured to move between a closed position in which the lid covers the opening and prevents waste from flowing therethrough, and an open position in which the lid remains coupled to the base but is moved away from the opening such that waste can flow from the stoma through the port.28. The method of Example 27, further comprising moving the lid from a closed position to an open position and evacuating waste from the stoma through the port.29. The method of Example 28, further comprising placing an opening of a waste collection bag or waste guide at or over the opening in the base such that waste flowing from the stoma enters an interior of the waste collection bag or waste guide.30. The method of Example 29, further comprising detaching the port from the wafer and removing the port from the body prior to evacuating waste.31. The method of any one of Examples 27 to 30, further comprising, prior to securing the wafer to the patient’s skin, removing a backing from a first side of an adhesive element and securing the first side of the adhesive element to the user’s skin around the stoma or to a back surface of the wafer.32. The method of Example 31, further comprising removing a backing from a second side of the adhesive element and securing the second side of the adhesive element to other of the user’ s skin around the stoma or the back surface of the wafer.33. The method of Example 32, further comprising removing the wafer from the user’s body, removing the adhesive element from the wafer, and adhering a new adhesive element to the wafer.BRIEF DESCRIPTION OF THE DRAWINGS
[0006] Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure.
[0007] FIG. 1 A is a perspective view of an ostomy port system in accordance with several embodiments of the present technology.
[0008] FIG. IB is a side view of the ostomy port system shown in FIG. 1A in accordance with several embodiments of the present technology.
[0009] FIG. 1C is a top view of the ostomy port system shown in FIGS. 1A and IB in accordance with several embodiments of the present technology.
[0010] FIG. 2 is an isolated view of the lid shown in FIGS. 1A-1C.
[0011] FIG. 3 is an isolated view of the base shown in FIGS. 1A-1C.
[0012] FIGS. 4A, 4B, and 4C are isolated perspective, top, and side views, respectively, of the wafer shown in FIGS. 1A-1C.
[0013] FIG. 5 is a perspective view of an ostomy port in accordance with several embodiments of the present technology, shown in an open position.
[0014] FIG. 6 is an enlarged view of a coupling region of a lid of an ostomy port in accordance with several embodiments of the present technology.
[0015] FIGS. 7A and 7B are side and perspective views, respectively, of an ostomy port system in accordance with several embodiments of the present technology, shown in an open position.
[0016] FIGS. 8A-8E depict a method of using an ostomy port system of the present technology.DETAILED DESCRIPTION
[0017] FIG. 1A is a perspective view of an ostomy port system 10 (or “system 10”) in accordance with several embodiments of the present technology, shown in a closed position. The system 10 can include a wafer 400 configured to be adhered to a user’s skin around a stoma and an ostomy port 100 (or “port 100”) configured to be secured to the wafer 400. The ostomy system 10 has a bottom side 102a, a top side 102b opposite the bottom side 102a along a length of the system 10, a front side 104a, a back side 104b opposite the front side 104a along a height of the system 10, and two lateral sides 106a, 106b opposite one another along a width of the system 10. The terms “top,” “bottom,” “front,” “back,” and “lateral” are made with reference to the system 10 in a closed position when properly worn by a user. Thus, when the ostomy port system 10 is positioned, in a closed state, on a user’s body during normal use, the back side 104b is closest to the user’s body, the front side 104a faces away from the user’s body, and the top side 102b is closer to the user’s head than the bottom side 102a. It will be appreciated, however, that the system 10 can be used in any orientation (e.g., upside-down / with the bottom side 102a closer to the user’s head, turned on its side / with the lateral sides facing the user’s head and feet, etc.) and the foregoing directional terms are not intended to be limiting.
[0018] FIG. IB and 1C show lateral and top views, respectively, of the system 10 shown in FIG. 1A. Referring to FIGS. 1A-1C together as well as the isolated views of the wafer 400 in FIGS. 4A-4C, the wafer 400 is configured to be positioned on the user's skin around and in sealing engagement with the stoma. The wafer 400 is flexible and reusable, providing a durable interface between the body and the port 100. The wafer 400 defines an opening 402 within which the stoma is received. In some embodiments, the wafer 400 comprises a synthetic elastomer, such as silicone rubber or other suitable materials. The wafer 400 is configured to be temporarily adhered to the user’s body via an adhesive. In some embodiments, the wafer 400 is provided with an adhesive pre-applied to its back surface. In other embodiments, the system 10 includes one or more doublesided adhesive elements (not shown) separate from the wafer 400. In use, a user may peel the backing off one side of the adhesive element and adhere the exposed side to the skin around the stoma or a back surface of the wafer 400. The user may then peel the backing off the other side of the adhesive element and adhere the newly exposed side to the other of the skin around the stoma or the back surface of the wafer 400, thereby securing the wafer 400 to the body. In use, the user may remove the wafer 400 from the body, remove the used adhesive element from the wafer 400and / or body, rinse or wash the wafer 400, then utilize a new adhesive element to re-adhere the cleaned wafer 400 to the stoma. In some cases, the adhesive element may comprise a hydrocolloid adhesive, which may be especially beneficial in ostomy applications because hydrocolloid adhesives are gentle on the skin (which can be crucial for ostomy patients who need to wear the port continuously), absorbent (which helps manage moisture around the stoma and maintain skin integrity and seal), flexible and conformable (which is advantageous given the variety of stoma shapes and sizes), amongst other advantages. In other embodiments, the adhesive element can include a hydrogel adhesive, a rubber-based adhesive, a polyurethane adhesive, soft-silicone adhesive, and / or others.
[0019] The wafer 400 can include one or more base coupling elements configured to engage one or more wafer coupling elements of the base 300 to provide a secure and leak-proof connection between the wafer 400 and the base 300. For example, as shown in FIGS. 4A-4C, in some embodiments a front side of the wafer 400 can include a protrusion 404 extending away from the wafer body 401 and configured to be received by a complementary groove (not visible in FIG. 3) on the back side of the base 300 in a snap-fit or other arrangement. The protrusion 404 can be an annular protrusion (e.g., extends 360 degrees around the opening 402) or may have other configurations.
[0020] According to some examples, the wafer 400 and base 300 are not provided separately and instead are fixed to one another during manufacturing and / or are integral with one another (e.g., formed of the same continuous material). In the former embodiments, the wafer 400 and base 300 may be formed of different materials or the same materials.
[0021] In some embodiments, the wafer 400 may include a connector configured to be detachably coupled to an external waste collection member (such as an ostomy bag) or waste guidance member (such as a funnel, as described herein). This way, the user has the option of draining waste directly through the port into a separate waste container (such as a toilet), or attaching an ostomy bag if desired.
[0022] The wafer 400, adhesive element, and / or any component or portion of the system 10 may be custom fit to the user’s stoma. For example, a digital or physical model of the stoma can be obtained using 3D-scanning, impression kits, measurement kits, LiDAR imaging, etc. The custom-shaped wafer 400 (or any custom portion of the system 10) beneficially provides animproved seal, improved anchoring to the body, and less irritation to the user’s skin. While the shape and size of a stoma can vary significantly from person to person, current ostomy care products (e.g., ostomy bags and bag connection plates) are typically one-size-fits-all. Many ostomates spend a great deal of time cutting each bag or plate to the correct shape, as well as using additional securing devices and accessories to achieve the correct fit. When the bags fit poorly, users encounter leakages and severe skin irritation, among other issues. The customized ostomy port system 10 of the present technology is tailored to each user’s unique anatomy, thus eliminating the extra time and money previously spent on modification or supplementing the port.[0023| For example, a cross-sectional shape of the opening 402 in the wafer 400, a cross- sectional dimension of the opening 402, a size of the wafer body 401, and / or a shape of the wafer body 401 can be designed to meet a particular user’s anatomy. Additionally or alternatively, a size and / or shape of the adhesive element can be designed to meet a particular user’s anatomy. In some embodiments, one or both of the wafer 400 and adhesive element is not custom fit. In those embodiments in which the adhesive element is provided as an annular member with a central opening, a cross-sectional shape and / or dimension of the opening in the adhesive element can be customized. It will be appreciated that the adhesive element can have other forms, including multipiece or single but discontinuous forms.
[0024] Referring now to FIGS. 1A-1C and 3, the base 300 can comprise a base body 301 defining an opening 302 configured to receive a stoma. The base body 301 can be formed of a single piece of material (e.g., molded, cast, 3D-printed, etc.) or multiple pieces fixed together. The base body 301 can be formed of a thermoplastic polymer, such as high-density polyethylene (“HDPE”) and other suitable materials. An inner surface 303 of the base body 301 can surround the opening 302 and thus is configured to be positioned adjacent or in contact with the perimeter of the stoma. In some embodiments, the base 300 can include a buffer (not shown) disposed around all or a portion of the inner surface 303 and configured to provide a softer, more conformable surface for engaging the irregularly shaped stoma and / or to provide a tight seal around the circumference of the stoma. The buffer may be fixed to the inner surface 303 or may be provided as an optional insert. In any case, the buffer may comprise a synthetic elastomer, such as silicone rubber or other suitable materials.
[0025] As previously discussed, a back side of the base 300 is configured to be detachably coupled to the wafer 400 in sealing engagement. Likewise, a top side of the base (visible in FIG. 3) can be configured to engage the lid 200 in sealing engagement. For example, the system 10 can optionally include an O-ring or other sealing member positioned between and / or in engagement with both the front side of the base 300 and the back side of the lid 200. In some embodiments, a front side of the base 300 can include a groove 306 configured to receive a sealing member, such as an O-ring, that gets compressed when the lid 200 is secured over the base 300. The base 300 may further include a groove 308 configured to receive a complementary protrusion on the back side of the lid 200. The groove 308 and protrusion may engage one another to provide an additional seal between the base 300 and the lid 200, as well as further secure the lid 200 to the base 300 in the closed position. The base 300 further includes a first coupling region 304 at its bottom side and a second coupling region 310 at its top side, each configured to be coupled to a portion of the lid 200, as detailed below.
[0026] As discussed below, the base 300 (and ostomy port system 10 in general) is configured to be temporarily adhered to the user and removable at any time. No portion of the system 10 is configured to be implanted.
[0027] The base 300 may be custom fit to the user’s stoma. For example, a cross-sectional shape of the opening 302 in the base 300, a cross-sectional dimension of the opening 302, a shape and / or topography of the inner surface 303, a shape and / or topography of the buffer, a size of the base body 301 (e.g., length, width, and / or height), and / or a shape of the base body 301 can be designed to meet a particular user’s anatomy. In some embodiments, the base 300 is not custom fit.
[0028] Referring now to FIGS. 1A-1C, 2, and 5, the lid 200 is coupled to the base 300 and configured to move between a first or closed position (FIGS. 1A-1C) in which the lid 200 covers the opening 302 in the base 300 and is in sealing engagement with the base 300, thereby preventing leakage of waste material, and a second or open position (FIG. 5) in which the lid 200 remains coupled to the base 300 but is moved away from the opening 302 to allow waste to flow from the stoma through the port 100. As such, waste may be evacuated from the stoma while the lid 200 is still attached to the base 300 which simplifies the waste-emptying process reduces mess. Once thestoma has been evacuated, the lid 200 may then be closed again, e.g., to prevent any leaks until the user is ready to next empty the stoma.
[0029] When in the closed position, the coupling region 210 of the lid 200 detachably engages the second coupling region 310 of the base 300 at the securing region 110 (FIG. 1A) to secure the lid 200 and prevent it from reopening. In some embodiments, the securing region 110 is disposed at a top side of the port 100. Additionally or alternatively, the securing region 110 may be disposed at one or both lateral sides 106a, 106b of the port 100. In some examples, the lid 200 detachably couples to the base 300 only at one or both lateral sides 106a, 106b. Such an arrangement can be beneficial as it simplifies the structure required at the top side of the lid 200. When the lid 200 is open during an emptying procedure, the top side of the lid 200 is in the path of waste material flow. As such, locating the securing region(s) laterally or otherwise away from the top side allows the portion of the lid 200 in the flow path to have a smooth and / or flat shape, or whatever contour is conducive to unobstructed waste flow.
[0030] As best shown in FIG. 5, an inner surface 202 of the lid 200 can be concave to accommodate the top of the stoma and / or the folded up / collapsed membrane 700 (see FIGS. 7A and 7B) (if the port 100 includes a membrane 700, which is optional). In some embodiments, all or a portion of the lid 200, including the portion 204 covering the opening 302 in the base 300, can be formed of a flexible material that can be deformed between a concave position (as shown in FIG. 5) and a convex position (not shown), similar to a “pop it” toy. In the convex position, the inner surface 202 is more flush with the perimeter of the lid 200 and thus advantageously presents a smoother path along which waste can flow during an emptying procedure. In some embodiments, the inner and / or outer surface of the lid 200 is substantially flat. In these and other embodiments, the lid 200 may be configured to include a protrusion on its inner surface 202 that is configured to press against the stoma when the port 100 is closed to resist / counteract any pressure from the stoma's waste.
[0031] In some embodiments, the lid 200 is rotatably coupled to the first coupling region 304 (FIG. 3) of the base 300 at a joint 108 (FIG. 1C) and is configured to rotate about the joint 108 between the open and closed positions. The joint 108 can be an embedded hinge that presents a smooth outer surface to the user. Other rotatable joints are possible. The lid 200 may be configured to rotate up to 180 degrees between the closed and fully open positions to allow theuser more flexibility when emptying the stoma. In FIG. 5, the lid 200 is shown at about a 90-degree position.
[0032] The lid 200 may be movably coupled to the base 300 via other means. For example, the lid 200 may be slidably coupled to the base 300 such that the lid 200 slides over the opening 302 (as opposed to rotating away from the opening 302, as shown in FIG. 5B). In other embodiments, the lid 200 may comprise a rotatable cap that is tethered to the base 300.
[0033] The lid 200 can be formed of a thermoplastic polymer, such as HDPE and other suitable materials. As depicted in the drawings, the lid 200 may optionally have a rounded shape as well as grip lines to facilitate easy opening and closing by the user.
[0034] The lid 200 may be custom fit to the user’s stoma. For example, a size of the lid 200 (e.g., length, width, and / or height), a shape of the lid 200, and / or a curvature of the lid 200 can be designed to meet a particular user’s anatomy. In some embodiments, the lid 200 is not custom fit.
[0035] As shown in FIG. 6, in some embodiments the lid 200 can optionally include a cover 600 that extends away from an inner surface of the lid 200. One end of the cover 600 is fixed to the inner surface of the lid 200 and the other end remains free. The cover 600 may be flexible and sit within the port 100 when the port 100 is closed. When the port 100 is in an open position, the cover 600 may be positioned over the top edge of the lid 200 (e.g., where the coupling region 210 is), thereby providing a smooth path over the gaps and protrusions presented by the coupling region 210 and / or top edge of the lid 200. The user may transition the cover 600 between its stored and open positions and / or the cover 600 may be formed of a resilient material that is biased to assume the open / extended position when the port 100 is open. In some embodiments, the port 100 does not include the cover 600.
[0036] FIGS. 7A and 7B are side and perspective views, respectively, of an ostomy port system 10 including a membrane 700 for guiding or channeling waste material during emptying of the stoma. The features of the ostomy port system 10 of FIGS. 7A and 7B are generally similar to the features of the ostomy port system 10 of FIGS. 1A-6. Accordingly, like numbers are used to identify similar or identical components in FIGS. 7A and 7B, and the discussion of the ostomy port system 10 of FIGS. 7A and 7B will be limited to those features that differ from the ostomy port system 10 of FIGS. 1A-6 (e.g., the membrane 700). Moreover, although the membrane 700 is described with respect to a port 100 that includes a cover 600, it will be appreciated that thecover 600 is optional and the membrane 700 can be used with ports 100 that do not includes a cover 600.
[0037] The membrane can comprise a variety of hydrophobic, flexible, durable materials, such as a polymer fabric (e.g., nylon, ripstop nylon, etc.) and / or other suitable materials. The membrane 700 can have a first end fixed to the base 300 and a second end fixed to the lid 200 such that the membrane 700 extends between the base 300 and the lid 200. The membrane 700 can be configured to move between a collapsed and / or compacted state when the lid 200 is in the first position / the port 100 is closed, and an extended state when the lid 200 is in the second position / the port 100 is open. When the port 100 is closed, the membrane 700 fits compactly within the port 100, for example within a space bound by the stoma, base 300, and lid 200. In this collapsed configuration, the membrane 700 may beneficially provide a secondary seal against the stoma.
[0038] In some embodiments, the membrane 700 has one or more predefined folds (e.g., one, two, three, four, five, six, seven, eight, nine, 10 or more) along its length such that the membrane 700 expands and collapses along these folds (for example, like an accordion). In these and other embodiments, the membrane 700 may comprise an elastic material that stretches and compresses during opening and closing of the port 100, respectively. According to some examples, the membrane 700 has no predefined folds.
[0039] As best shown in FIG. 7B, the membrane 700 can comprise an open chute extending between the base 300 and lid 200. Said another way, in some examples the membrane 700 extends around less than a full diameter of the base opening 302 such that an interior cavity 606 of the membrane 700 is open to the user. The membrane 700 comprises a bottom sidewall 704 and lateral sidewalls 702 extending upwardly and laterally away from the bottom sidewall 704. When the port 100 is open, the membrane 700 ensures waste material does not pour through the gaps between the opened lid 200 and the base 300.
[0040] In any of the foregoing examples, the system 10 may optionally include a sensor for sensing one or more parameters within a space enclosed by the stoma, wafer, base, and lid. The sensor may be incorporated into the lid or base. In some embodiments, the system 10 may be configured to notify a user when evacuation of the ostomy port is recommended based on data obtained by the sensor. The notification can be, for example, haptic feedback, a sound, and / or a light on the port 100. The sensor may be a pressure sensor, a chemical sensor, and / or others.
[0041] FIGS. 8A-8E show an example method for assembling and attaching the ostomy port system 10 to the user. While the port 100 shown in FIGS. 8A-8E includes a membrane 700, it will be appreciated that the same methods apply to a port 100 without a membrane 700, as disclosed herein. As shown in FIG. 8 A, the user can apply the adhesive element to the back of the wafer 400 and position a first portion of the wafer 400 snugly around the stoma, in contact with the peristomal skin. The user can then roll the remainder of the wafer 400 (and adhesive backing) onto the skin, pressing the wafer 400 gently onto the body and holding for a few seconds to activate the adhesive.
[0042] As shown in FIG. 8B, once the wafer 400 has firmly attached to the skin and created a sufficient seal around the stoma, the user then attaches the port 100 to the wafer 400, for example by pressing the back side of the port 100 against the front side of the wafer 400 until the respective coupling regions engage. Other means for coupling the port 100 to the wafer 400 are possible, such as via sliding engagement (sliding the port 100 into tracks on the wafer 400) or rotational engagement (screwing or otherwise rotating the port 100 onto the front of the wafer 400). In any case, engagement of the port 100 and the wafer 400 can provide an audible sound (e.g., an audible snap or similar sound) to indicate to and reassure the user that the port 100 and wafer 400 are securely attached.
[0043] The user can then go about their day, opening the lid 200 as needed, for example to check on their stoma or empty waste in the restroom. FIG. 8C shows the user opening the port 100 by releasing the secure connection (such as securing region 110) at the top of the port 100 and rotating the lid 200 downwardly. In these and other embodiments, the port 100 may be opened by releasing a securing region at one or both lateral sides of the port 100. In other embodiments, the port 100 may be opened by releasing a securing region at the bottom or either lateral side of the port 100 and rotating the lid 200 upwardly or laterally, respectively, away from the body.
[0044] When emptying the port 100, the user may angle the port 100 such that the waste flows into a separate waste receptable (such as a toilet), or the user may attach a separate waste collection element to the port. For example, in some cases a user may couple an ostomy bag to the port via mating connectors on the bag and port. In some examples, the system 10 can include a funnel and / or chute 800 (shown in FIG. 8D) which can be positioned over the open port 100 and helps guide waste to its final receptacle (e.g., the toilet or another container). The funnel can comepackaged in a compacted form, making it easy for the user to carry multiple on their person discreetly. The funnel also provides extra length (e.g., 6 inches or more, 12 inches or more) reduces the distance from the port to the toiler (or other container) and reduces any splash-back. The funnel can be made of polyvinyl alcohol or materials similarly compactable, lightweight, and flushable and water-soluble at room temperature. Once finished, the user can either flush the funnel or throw it away in the garbage bin. If there is any output residue remaining on the port 100 or membrane 700, the user can wipe or rinse either part clean. The system 10 thus allows the user to bypass the need for a bag altogether in the emptying process.[0045| As shown in FIG. 8E, the user can lock the lid 200 back into place on the base 300 once the emptying and cleaning process is complete.
[0046] The ostomy port systems of the present technology are removable from the patient, in their entireties, by the patient at any time. Some existing ostomy port solutions require a base that gets implanted around the stoma. However, many users are hesitant to permanently implant a foreign structure within their abdomen. The port systems disclosed herein offer a less permanent solution with greater flexibility.Conclusion
[0047] Other embodiments in addition to those described herein are within the scope of the technology. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described above with reference to FIGS. 1A-8E.
[0048] The descriptions of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Where the context permits, singular or plural terms may also include the plural or singular term, respectively. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.
[0049] As used herein, the terms “generally,” “substantially,” “about,” and similar terms are used as terms of approximation and not as terms of degree, and are intended to account for the inherent variations in measured or calculated values that would be recognized by those of ordinary skill in the art.
[0050] Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term "comprising" is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and / or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.
Claims
CLAIMSI / We claim:
1. An ostomy port, comprising: a flexible wafer configured to be positioned on a user’s skin around and in sealing engagement with a stoma, the wafer defining a first opening configured to receive the stoma; a base configured to be detachably coupled to the wafer, the base defining a second opening and configured to be positioned on the wafer such that the first and second openings are aligned; and a lid coupled to the base, wherein the lid is configured to move between a closed position in which the lid covers the second opening and prevents waste from flowing therethrough, and an open position in which the lid remains coupled to the base but is moved away from the second opening such that waste can flow from the stoma through the port.
2. The ostomy port of Claim 1, wherein the wafer is custom fit to the user’s stoma.
3. The ostomy port of Claim 2, wherein the cross-sectional shape of the first opening, a cross-sectional dimension of the first opening, a size of the wafer, and / or a shape of the wafer are customized to the user’s stoma.
4. The ostomy port of Claim 1, wherein the wafer is configured to be adhered to the user’s skin via an adhesive.
5. The ostomy port of Claim 1, wherein the portion of the wafer defining the first opening is configured to form a seal around the circumference of the stoma.
6. The ostomy port of Claim 1, wherein the wafer is reusable.
7. The ostomy port of Claim 1 , wherein the wafer includes a connector configured to be detachably coupled to an external waste collection member and / or waste guidance member.
8. The ostomy port of Claim 1, wherein the base is custom fit to the user’s stoma.
9. The ostomy port of Claim 1, wherein a cross-sectional shape of the second opening, a cross-sectional dimension of the second opening, a cross-sectional dimension of the base, a height of the base, and / or a shape of the base are customized to the user’s stoma.
10. The ostomy port of Claim 1, wherein the base includes a connector configured to be detachably coupled to an external waste collection member and / or waste guidance member.
11. The ostomy port of Claim 1, wherein a back side of the base includes a groove and a front side of the wafer includes a complementary projection configured to fit within the groove, thereby securing and forming a seal between the wafer and the base.
12. The ostomy port of Claim 1, wherein the lid is coupled to the base at a hinge and is configured to rotate about the hinge between the open and closed positions.
13. The ostomy port of Claim 12, wherein the lid is configured to rotate up to 180 degrees between the closed and fully open positions.
14. The ostomy port of Claim 1, wherein the lid is slidably coupled to the base.
15. The ostomy port of Claim 1, wherein no portion of the ostomy port extends into the stoma and / or below the user’s skin.
16. The ostomy port of Claim 1, wherein no portion of the ostomy port is surgically adhered or otherwise implanted into the user.
17. The ostomy port of Claim 1 , further comprising a membrane having a first end coupled to the base and a second end coupled to the lid, wherein the membrane is in a collapsed state when the lid is in the closed position and an extended state when the lid is in the open position.
18. The ostomy port of Claim 17, wherein the membrane borders and extends away from less than a full diameter of the base such that the membrane provides bottom and lateral sidewalls to guide waste exiting the stoma while a top side of the base remains open, thereby providing the user access to an inner surface of the membrane.
19. The ostomy port of Claim 1, further comprising a pressure sensor for sensing pressure within a space enclosed by the stoma, wafer, base, and lid.
20. The ostomy port of Claim 19, wherein the ostomy port is further configured to notify a user when evacuation of the ostomy port is recommended based on pressure data obtained by the pressure sensor.
21. An ostomy port system comprising: a flexible wafer configured to be positioned on a user’s skin around and in sealing engagement with a stoma, the wafer defining a first opening configured to receive the stoma; and a port configured to be detachably coupled to the wafer, the port comprising: a base defining a second opening; and a lid coupled to the base, wherein the lid is configured to move between a closed position in which the lid covers the second opening and prevents waste from flowing therethrough, and an open position in which the lid remains coupled to the base but is moved away from the second opening such that waste can flow from the stoma through the port, wherein no portion of the port extends into the stoma and / or below the user’s skin.
22. The ostomy port system of Claim 21, further comprising an adhesive element provided separate from the wafer and having a top side configured to be adhered to a front surface of the wafer and a back side configured to be adhered to the user’s skin.
23. The ostomy port system of Claim 21, wherein the adhesive element is custom fit to the user’s stoma.
24. The ostomy port system of Claim 21, wherein a cross-sectional shape of the adhesive element, a cross-sectional dimension of an opening in the adhesive element, and / or a cross-sectional dimension of the adhesive element are customized to the user’s stoma.
25. The ostomy port system of Claim 21, further comprising a waste collection bag configured to be coupled to the port and configured to receive waste evacuated from the stoma through the port.
26. The ostomy port system of Claim 21, further comprising a waste chute configured to be coupled to the port and configured to receive waste evacuated from the stoma through the port.
27. A method of using an ostomy port, comprising: securing a wafer to a user’ s skin around a stoma; securing a port to the wafer, the port comprising: a base defining an opening; and a lid coupled to the base, wherein the lid is configured to move between a closed position in which the lid covers the opening and prevents waste from flowing therethrough, and an open position in which the lid remains coupled to the base but is moved away from the opening such that waste can flow from the stoma through the port.
28. The method of Claim 27, further comprising moving the lid from a closed position to an open position and evacuating waste from the stoma through the port.
29. The method of Claim 28, further comprising placing an opening of a waste collection bag or waste guide at or over the opening in the base such that waste flowing from the stoma enters an interior of the waste collection bag or waste guide.
30. The method of Claim 28, further comprising detaching the port from the wafer and removing the port from the body prior to evacuating waste.
31. The method of Claim 27, further comprising, prior to securing the wafer to the patient’s skin, removing a backing from a first side of an adhesive element and securing the first side of the adhesive element to the user’s skin around the stoma or to a back surface of the wafer.
32. The method of Claim 31, further comprising removing a backing from a second side of the adhesive element and securing the second side of the adhesive element to other of the user’s skin around the stoma or the back surface of the wafer.
33. The method of Claim 32, further comprising removing the wafer from the user’ s body, removing the adhesive element from the wafer, and adhering a new adhesive element to the wafer.
Citation Information
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