Coupling system for ostomy appliance

Abstract

The present disclosure is a coupler assembly for an ostomy appliance. The coupler assembly has a body-side coupler defining a female receiving portion and configured to be selectively couplable to a user, and a bag-side coupler defining a male portion sized to be selectively couplable to the female receiving portion of the body-side coupler, the bag-side coupler is configured to be coupled to an ostomy bag. When the male portion is coupled to the female receiving portion, providing a pulling force on the ostomy bag increases a separating force required for separating the male portion from the female receiving portion relative to a case where the male portion is coupled to the female receiving portion in a neutral state.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This disclosure claims the benefit of U.S. Provisional Application No. 63 / 357,851, filed on July 1, 2023, the contents of which are hereby incorporated herein in their entirety. Technical Field

[0003] The present invention relates to an ostomy coupler for removably attaching an ostomy appliance to a body attachment worn on the body of an ostomate, and more particularly to providing a body attachment with a coupling component that provides an enhanced coupling. Background Art

[0004] The present invention relates to a device that is attached to a patient's body after they undergo an ostomy surgical procedure to address their gastrointestinal problems. The various problems they experience interfere with their body's normal process for handling and collecting waste products from the digestive process. These patients are called ostomates, and they are typically required to wear and maintain these waste collection devices for the rest of their lives. In essence, the device typically consists of an adhesive "ring" that surrounds the outlet of the stoma that comes out of their abdomen. The adhesive adheres to the patient on one side and to a collection bag on the other side. The purpose of this system is to provide a liquid seal and a reasonably airtight seal during surgery, allowing ostomates to enjoy an active and socially engaged life.

[0005] U.S. Pat. No. 4,419,100, U.S. Pat. No. 4,610,676, U.S. Pat. No. 4,610,677, U.S. Pat. No. 5,730,735, U.S. Pat. No. 5,312,382, U.S. Pat. No. 8,366,695 (hereinafter "the '695 patent"), and U.S. Pat. No. 8,382,732 (hereinafter "the '732 patent") teach an ostomy coupler designed to reduce the discomfort experienced by some ostomates due to the attachment forces applied to the skin by the body attachment when the two attachment components are pressed together. The problem of discomfort is particularly important during postoperative care when the ostomy surgery is recent and the abdominal skin is very tender. These documents teach a flexible loop-type suspension device permanently secured between an adhesive sheet and the attachment components of the body attachment. The flexible collar allows the coupling component to be displaced from or "float" relative to the adhesive sheet, at least by a sufficient amount for a user to insert one or more fingers behind the coupling component to manually support the coupling component against the attachment force when the device is pressed against the body attachment. Such coupling components are generally referred to in the art as floating coupling components.

[0006] Typically, these ostomy devices are designed so that the collecting bag is detachable from the adhesive by a coupling flange. This allows a new bag to be reattached without damaging the underlying ring. This extends the life of the adhesive, reduces costs, and minimizes irritation to the patient's skin from too frequent adhesive changes. Typically, products with this construction are referred to as "two-piece" ostomy devices.

[0007] Another disadvantage of typical designs is that the forces required to separate / disconnect / uncouple and reconnect the flanges act directly against the patient's abdomen. The '695 patent and the '732 patent teach a two-piece ostomy device designed to reduce the discomfort experienced by many ostomates due to the attachment and detachment forces exerted by the coupler.

[0008] The '695 design focuses on the period after initial surgical care when the wound is particularly swollen and sensitive. During this time, the physician and postoperative staff will care for the patient. The coupler is fixed at an extended distance away from the patient. This provides space for the caregiver to easily support the coupler during removal and reattachment, thereby isolating the forces from the patient's abdomen.

[0009] The '732 patent addresses the situation that occurs in more common, normal, daily life when a patient wears a collection device after the recovery period from surgery. The connector can be temporarily extended / elongated (or "floated") by a flexible membrane. This improves accessibility / accessibility for maintenance by allowing the wearer to insert space for one or more fingers behind the connector. The wearer can support and isolate the reaction forces caused by flange separation and reconnection. The connector can then be collapsed back to a flat position for wearing, thereby improving comfort and appearance under clothing. The '732 patent describes a preferred embodiment in which the connector is actually "bistable" (i.e., remains stable in the collapsed state to resist movement or sagging for an active wearer, and remains stable in the extended state when the wearer manipulates the bag connector).

[0010] In a typical two-piece ostomy device, the body-side and bag-side coupling flanges are manufactured separately from the flexible film. The flexible film is then coupled to the body-side flange and the bag-side flange. In a typical two-piece device, the attachment of the flexible film to the body-side flange has proven to be problematic. More particularly, stretchable films are typically produced by first extruding a thin, flat, flexible film made of a polyethylene copolymer or the like. The film is rolled up and then fed into a vacuum thermoforming operation to obtain a folded "accordion" shape. The accordion shape is then die-cut into individual components having the desired inner and outer diameter dimensions. The copolymer used for extrusion is selected to optimize flexibility while still providing a sufficiently rigid structure to achieve bi-stability.

[0011] Thin film extrusions are prone to potentially contain small bubbles and foreign particles, resulting in small holes through the film. This requires careful process control. Thermoforming processes inherently cannot control wall thickness, resulting in particularly thin walls where the film needs to stretch the most. These two factors combine to produce intermittent small holes through the film that are not detected until the subassembly is produced and leak tested.

[0012] The body side flange and accordion / foldable film are brought together and joined together by a heat welding operation to form a subassembly for further processing into a finished product. Handling the film with automated assembly equipment and placing the film precisely concentrically with the flange prior to welding has proven to be challenging. The subsequent welding operation and in-process leak and dimensional testing are both sources of significant non-recyclable scrap.

[0013] The present invention solves, among other things, those problems which are problems in the prior art. Summary of the invention

[0014] The present disclosure is a coupler assembly for an ostomy appliance. The coupler assembly has a body-side coupler and a bag-side coupler, the body-side coupler defining a concave receiving portion and configured to be selectively coupled to a user, the bag-side coupler defining a convex portion sized to be selectively coupled to the concave receiving portion of the body-side coupler, the bag-side coupler configured to be coupled to an ostomy bag. When the convex portion is coupled to the concave receiving portion, providing a pulling force on the ostomy bag increases the separation force required to separate the convex portion from the concave receiving portion relative to the case where the convex portion is coupled to the concave receiving portion in a neutral state.

[0015] In one example of this embodiment, the concave receiving portion defines a locking edge for selectively coupling the convex portion to the concave receiving portion. As part of this example, the convex portion defines a locking shelf that is positioned to correspond to the locking edge of the concave receiving portion in the coupled configuration. In another aspect of this configuration, the ostomy bag is coupled to the bag-side coupler at a position radially outward of the locking shelf with reference to the coupler through-holes. In another aspect of this embodiment, the body-side coupler is coupled to the bridging ring at a position radially inward of the locking edge with reference to the coupler through-holes, such that when a pulling force is applied to the ostomy bag, the locking edge and the locking shelf are at least partially forced toward each other relative to a neutral state.

[0016] Another example of this embodiment is an accordion-shaped membrane / foldable membrane defined in the body-side coupler between the concave receiving portion and the bridging ring weld. In this example, the concave receiving portion and the foldable membrane are formed by the same material in the same manufacturing process.

[0017] Another example of this embodiment has a deflectable seal defined around the male portion at a position radially inward relative to the locking shelf with reference to the coupler through hole. A portion of this example has a sealing wall defined in the female receiving portion, wherein when the male portion is coupled to the female receiving portion, the deflectable seal contacts the sealing wall to substantially seal the interior of the ostomy bag from the surrounding environment.

[0018] Another example of this embodiment has a bridging ring coupled to the body-side coupler on a first side and having an adhesive on a second side configured to selectively couple to the abdominal wall of a user around a stoma.

[0019] In another example of this embodiment, the body side coupler is made of polyethylene. In a part of this example, the bag side coupler is formed of EVA.

[0020] In another example of this embodiment, the concave receiving portion of the body-side coupler is directly welded to the sheet. Another example of this embodiment has a flange defined by the bag-side coupler extending radially outward relative to the coupler through hole, and the ostomy bag is welded to the bag-side coupler along the surface of the flange. In yet another example of this embodiment, the concave receiving portion of the body-side coupler has a convex flange offset from the flat surface of the concave receiving portion.

[0021] Another embodiment of the present disclosure is a method of manufacturing a coupler assembly for an ostomy appliance. The method includes: forming a body-side coupler defining a concave receiving portion; forming a bag-side coupler defining a male portion sized to selectively couple to the concave receiving portion; coupling the body-side coupler to a bridging ring; and coupling the bag-side coupler to an ostomy bag. In this embodiment, the male portion is coupleable to the concave receiving portion in a coupled configuration, wherein providing a pulling force on the ostomy bag increases the separation force required to separate the male portion from the concave receiving portion relative to when the male portion is coupled to the concave receiving portion in a neutral state.

[0022] A portion of this embodiment includes forming a foldable membrane in the body-side coupler between the concave receiving portion and the bridging ring. One aspect of this example includes forming the concave receiving portion and the foldable membrane in the same manufacturing step. In another aspect of this example, the step of coupling the body-side coupler to the bridging ring includes fusing a portion of the foldable membrane to the bridging ring along the bridging ring weld.

[0023] Another example of this embodiment includes coupling an adhesive to the bridging ring to selectively couple the body-side coupler to the abdominal wall of the user. Yet another example includes welding the ostomy bag to a flange formed in the bag-side coupler along the bag weld.

[0024] Another example of this embodiment includes forming a locking edge in the concave receiving portion and forming a locking shelf in the convex portion, wherein the locking edge and the locking shelf correspond to each other to substantially maintain the body-side coupler and the bag-side coupler in a coupled configuration. A portion of this example includes forming a deflectable seal in the convex portion and forming a sealing wall in the concave receiving portion, wherein when in the coupled configuration, the deflectable seal provides a fluid seal between the bag-side coupler and the body-side coupler. In one aspect of this portion, the deflectable seal is positioned to provide a biasing force of the locking shelf toward the locking edge to maintain the coupled configuration.

[0025] In another example of this embodiment, the body-side coupler and the bag-side coupler are formed by an injection molding process. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The above aspects of the present disclosure and the manner of obtaining the same will become more apparent, and the present disclosure itself will also be better understood, by referring to the following description of the embodiments of the present disclosure in conjunction with the accompanying drawings, in which:

[0027] Figure 1 is a front perspective view of the coupling assembly;

[0028] Figure 2 for Figure 1 a front perspective view of a body side coupler of the illustrated coupler assembly;

[0029] Figure 3 for Figure 1 a front perspective view of a bag side coupler of the illustrated coupler assembly;

[0030] Figure 4 for Figure 3 Side view of the middle bag side connector;

[0031] Figure 5 Connected to the abdominal wall around the stoma Figure 1 a front perspective cutaway view of the illustrated coupling assembly;

[0032] Figure 6 for Figure 5 A side cross-sectional view of

[0033] Figure 7 for Figure 5 Detailed side cross-sectional view of

[0034] Figure 8 for Figure 3 a detailed side cutaway view of the bag side coupler shown;

[0035] Fig. 9 for Figure 2 a detailed side cutaway view of the mid-body side coupler;

[0036] Fig.10 is a detailed side cross-sectional view of another embodiment of a body-side coupler;

[0037] Fig.11 is a detailed side cross-sectional view of another embodiment of a body-side coupler assembly; and

[0038] Fig.12 is an exemplary manufacturing flow chart for a coupling assembly.

[0039] Corresponding reference characters are used to indicate corresponding parts throughout the several views. DETAILED DESCRIPTION

[0040] The embodiments of the present disclosure described below are not intended to be exhaustive or limit the present disclosure to the precise forms described in the following detailed description. Instead, these embodiments are selected and described to enable others skilled in the art to understand and appreciate the principles and practices of the present disclosure.

[0041] The present disclosure relates to a Figure 1 A coupler assembly 100 for an ostomy device is shown. The coupler assembly 100 is configured to define a coupler through hole 102, which is defined around an axis 110 and is sized to be positioned around the stoma of a user or "ostomate". The coupler assembly 100 has a bag side coupler 104 of a body side coupler 106, which is selectively coupled to the body side coupler 106. The bag side coupler 104 is typically coupled to a bag or the like, and the body side coupler 106 is typically coupled to the ostomate around the stoma. When the bag side coupler 104 is coupled to the body side coupler 106 and positioned around the stoma of the ostomate, material from the ostomate can pass through the coupler through hole 102 and enter and remain in the bag for further processing. When the bag is filled with material, the bag side coupler 104 can be removed from the body side coupler 106, so that the bag and the material therein can be discarded, cleaned, etc. Subsequently, a clean bag having a bag-side coupler 104 may be coupled to the body-side coupler 106 to capture material produced through the stoma.

[0042] The coupler assembly 100 may have a foldable membrane 108 defined in the body-side coupler 106. The foldable membrane 108 may allow the body-side coupler 106 to be partially separated from the stoma of the ostomate without the body-side coupler 106 being separated / disconnected from the ostomate. More particularly, the foldable membrane 108 may have one or more folds defined therein that allow the body-side membrane 106 to be positioned around the stoma near the skin of the ostomate in a first orientation and become separated from the skin of the ostomate in a second, stretched orientation. The foldable membrane allows the coupler assembly 100 to be separated from the skin of the ostomate while remaining coupled to the ostomate to further allow easy coupling and separation of the bag-side coupler 104 from the body-side coupler 106.

[0043] Reference Figure 2 , the body-side coupler 106 is shown separated from the bag-side coupler 104. The body-side coupler 106 has a locking rim 202 extending radially inward from the outer wall 204 toward the axis 110. The body-side coupler 106 generally defines a concave receiving portion 206 around the axis 110. The concave receiving portion 206 is an annular cavity in which a portion of the bag-side coupler 104 can be positioned. In addition, the locking rim 202 of the body-side coupler 106 can interact with the locking shelf of the bag-side coupler 104 to substantially prevent the bag-side coupler 104 from accidentally separating / decoupling from the body-side coupler 106, which will be described in more detail herein.

[0044] A sealing wall 208 may also be defined in the body-side coupler 106 to be partially formed as a radially inner portion of the concave receiving portion 206 relative to the outer wall 204. The sealing wall 208 may provide a sealing surface for a corresponding deflectable sealing portion of the bag-side coupler 104, thereby substantially / sufficiently sealing the perimeter of the concave receiving portion 206 to a corresponding convex portion of the bag-side coupler 104. In the coupled configuration, the bag-side coupler 104 is coupled to the body-side coupler 106 such that fluid is substantially unable to pass between the bag-side coupler 104 and the body-side coupler 106 at the concave receiving portion 206. In other words, when the bag-side coupler 104 is properly coupled to the body-side coupler 106, the ostomate's stoma and the interior cavity of the bag are substantially isolated from the surrounding environmental fluids.

[0045] Reference Figure 3 and Figure 4, the bag side coupling 104 shown is separated from the body side coupling 106 and the corresponding bag. The bag side coupling 104 defines a radially extending flange 302, which is configured to provide a coupling surface for the bag. The flange 302 can be coupled to the bag by any known coupling method, such as adhesive, ultrasonic welding or any other known coupling technology. The flange 302 can extend radially away from the convex portion 304 of the bag side coupling 104. The size of the convex portion 304 is determined to be selectively positioned in the concave receiving portion 206 of the body side coupling 106. The convex portion 304 has a locking shelf 306 defined in the convex portion 304 around the axis 110. The locking shelf 304 is a radial extension extending away from the axis 110 of the convex portion 304, to define a locking interface between the locking shelf 306 and the locking edge 202 when the bag side coupling 104 is coupled to the body side coupling 106.

[0046] The male portion 304 of the bag-side coupler 104 may further define a deflectable seal 308 that is configured to be partially positioned within the female receiving portion 206. The deflectable seal 308 may be sized to elastically deform radially away from the axis 110 by contact with the sealing wall 208 when the bag-side coupler 104 is coupled to the body-side coupler 106. Once the male portion 304 of the bag-side coupler 104 is fully positioned within the female receiving portion 206 of the body-side coupler 106, the deflectable seal 308 forms a fluid seal against the sealing wall 208, thereby preventing fluid from flowing from the interior of the bag to the surrounding environment via the coupler assembly 100 when the coupler assembly 100 is properly positioned around the stoma of an ostomate.

[0047] Reference now Figure 5 and Figure 6 , a cross-sectional view of a coupling assembly 100 coupled to an ostomate is shown. More particularly, a body-side coupling 106 is coupled to an abdominal wall 502 of an ostomate. The body-side coupling 106 is coupled to the abdominal wall 502 by an adhesive 504. As described herein, the accordion-shaped member / foldable member 108 can separate the adhesive-bearing portion of the body-side coupling 106 from the concave receiving portion 206, so that when the foldable member 108 is unfolded, the concave receiving portion 206 can become spaced apart from the abdominal wall 502 for easy access to the coupling assembly 100 without affecting the adhesive 504. The coupling assembly 100 can be coupled to the abdominal wall 502 around the stoma 506 of the ostomate using the adhesive 504.

[0048] Adhesive 504 may be coupled to the body-side surface of bridge ring 508. Bridge ring 508 may in turn be coupled to a portion of the foldable film on the opposite side of bridge ring 508 relative to the body-side surface. Bridge ring 508 may be coupled to foldable film 108 using any known coupling method. For example, bridge ring weld 510 may utilize ultrasonic welding technology to couple bridge ring 508 to foldable film 108. Alternatively, adhesive may be used to couple adjacent surfaces of bridge ring 508 and foldable film 108 to each other.

[0049] Although the bridge ring 508 is illustrated as a separate component from the foldable membrane 108, in one embodiment contemplated herein, the bridge ring 508 and the foldable membrane 108 can be formed as the same component. That is, the bridge ring 508 is formed in the same manufacturing process as the remaining components of the body side coupler 106.

[0050] Figure 5 and Figure 6 Also more clearly shown is the deflectable seal portion 308 positioned against the seal wall 208 in the coupled configuration 500. As described herein, when the bag-side coupler 104 is coupled to the body-side coupler 106, the deflectable seal portion 308 can be radially deflected away from the axis 110 by contact with the seal wall 208. More specifically, when the bag-side coupler 104 is oriented as shown in FIG. Figure 5 When the coupling configuration 500 is shown, the locking shelf 306 of the bag-side coupler 104 moves around the locking rim 202 of the body-side of the coupling to allow the male portion 304 of the bag-side coupler 104 to be positioned within the female receiving portion 206 of the body-side coupler 106. In the coupling configuration 500, the deflectable sealing portion 308 is positioned to at least partially press against the sealing wall 208 around the entire perimeter of the sealing wall 208. In this configuration, a substantially fluid-tight seal is formed between the bag-side coupler 104 and the body-side coupler 106 around the sealing wall 208.

[0051] As described herein, the bag-side coupler 104 can provide a flange 512 that extends radially outward from the convex portion 304 relative to the axis 110. The flange 512 provides a surface to which the bag 514 can be coupled. The bag 514 can provide a substantially contained interior region, wherein when the bag 514 is coupled to the flange 512 and the bag-side coupler 104 is coupled to the body-side coupler 106 and the assembly 100 is coupled to the ostomate around the stoma 506, fluids such as effluents passing through the stoma 506 are captured within the interior region of the bag 514. The bag 514 can be coupled to the flange 512 using any known technique. In one example, the bag 514 is coupled to the flange 512 by an ultrasonic welding technique that produces a bag weld 516. Alternatively, an adhesive can be used to couple the bag 514 to the flange 512.

[0052] In the coupled configuration 500, the male portion 304 is positioned within the female receiving portion 206 such that the locking shelf 306 of the male portion 304 is positioned within the female receiving portion 206 axially inward of the locking edge 202. The outer diameter of the locking shelf 306 may be slightly larger than the inner diameter of the locking edge 202 such that transitioning the male portion 304 into the female receiving portion 206 requires some deflection of one or both of the locking shelf 306 and the locking edge 202. Once in the coupled configuration 500, the locking shelf 306 and the locking edge 202 may return to their undeflected positions. Once the male portion 304 is properly positioned in the female receiving portion 206, the positioning of the locking shelf 306 within the female receiving portion 206 near the locking edge 202 may substantially prevent the bag-side coupler 104 from accidentally separating from the body-side coupler 106. More specifically, if the bag-side coupler 104 is pulled axially along the axis 110 in a direction away from the body-side coupler 106 , the locking shelf 306 will contact the locking rim 202 to substantially prevent accidental disengagement / detachment of the bag-side coupler 104 from the body-side coupler 106 .

[0053] The corresponding sizes of the locking edge 202 and the locking shelf 306 can be selected so that the user can easily connect the bag side coupler 104 to the body side coupler 106. However, once in the coupling configuration 500, the locking edge 202 and the locking shelf 306 can basically prevent the assembly 100 from being accidentally disengaged under normal use conditions. That is, the contact between the locking edge and the locking shelf 306 can prevent the assembly 100 from being disengaged under the normal weight and movement of the bag 514 and any contents therein. However, when the ostomy person specifically operates to pull the convex portion 304 out of the concave receiving portion 206, the bag side coupler 104 and the body side coupler 106 can be separated from each other. Therefore, the present disclosure contemplates the use of locking edges 202 and locking shelves 306 of different sizes to provide different coupling forces and separation force requirements. For example, if the radial overlap of the locking shelf 306 and the locking rim 202 increases, the coupling force and the separation force required to convert the bag-side coupler 104 and the body-side coupler 106 between the coupled configuration 500 and the separated configuration may be greater than when the radial overlap is relatively small. Therefore, the present disclosure contemplates selecting the dimensions of the locking rim 202 and the locking shelf 306 to allow a user to easily couple and separate the assembly 100 by manually manipulating the bag-side coupler 104 and the body-side coupler 106. However, the dimensions of the assembly 100 are also configured to prevent the bag-side coupler 104 from separating from the body-side coupler 106 under normal use conditions (e.g., when the bag 514 is being filled with effluent).

[0054] Reference Figure 7, a detailed cross-sectional view of the convex portion of the bag-side coupler 104 coupled to the body-side coupler 106 is shown, as well as the forces F1-F4 expected during use. More specifically, when the bag 514 is pulled in a direction away from the user, a pulling force F1 can be applied to the bag-side coupler 104 by the bag 514. The pulling force F1 can be applied to the bag-side coupler by the bag 514 at the bag weld 516. As an example, the pulling force F1 can be the expected force applied to the bag-side coupler 104 when the bag 514 is full of effluent. Alternatively, the pulling force F1 can be caused by the user or the like accidentally pulling the bag 514. In any case, by unfolding the foldable membrane 108, the bag-side coupler 104 and the body-side coupler 106 can be allowed to extend slightly away from the ostomate in response to the force F1.

[0055] However, once the foldable film 108 is fully extended, if the tension F1 persists, a response force F2 is generated where the foldable film 108 is attached to the concave receiving portion 206. When the foldable film 108 cannot be further extended, the response force F2 can substantially oppose the tension F1. In this configuration, the tension F1 is transmitted from the bag 514, through the male portion 304 and the concave receiving portion 206, through the foldable film 108, through the bridge ring weld 510 to the bridge ring 508, and via the adhesive 504 to the abdominal wall 502. If the tension F1 sufficiently exceeds the separation force 702 (i.e., the force required to separate the bag-side coupler 104 from the body-side coupler 106), the bag-side coupler 104 can be separated from the body-side coupler 106 when the male portion 304 exits the concave receiving portion 206.

[0056] The pulling force F1 and the response force F2 may also generate a shelf force F3 and an edge force F4 at the location where the locking shelf 306 and the locking edge 202 are adjacent to each other. Due to the radially offset position at which the bag 514 is coupled to the flange 512, the shelf force F3 may be at least partially directed toward the locking edge 202. In other words, because the pulling force F1 is applied to a location radially away from the locking shelf 306, the shelf force F3 applied to resist the pulling force F1 may drive the locking shelf 306 toward the locking edge 202. Similarly, the edge force F4 may be directed radially inward toward the locking shelf 306. This may be because the locking edge 202 is radially away from the location of the response force F2 acting on the concave receiving portion 206. In this way, the response force F2 may cause the edge force F4 to be directed toward the locking shelf 306.

[0057] By coupling the bag 514 to the bag-side coupler 104 at a location radially away from the locking shelf 306, when the pulling force F1 is applied, the convex portion 304 will be biased toward the locking rim 202 because the locking shelf 306 will slightly pivot toward the locking rim 202 due to the radially outward pulling force. Similarly, by coupling the body-side coupler 106 to the ostomate at a radially inner portion of the body-side coupler 106 relative to the locking rim 202, when the response force F2 opposes the pulling force F1, the concave receiving portion 206 will be biased to pivot the locking rim 202 toward the locking shelf 306. This configuration creates an increased required separation force 702 when the bag 514 pulls the bag-side coupler 104 from the body-side coupler 106 compared to when the user separates the bag-side coupler 104 from the body-side coupler 106 as described herein.

[0058] When a pulling force is applied to the bag-side coupler 104, the above-mentioned force allows the bag-side coupler 104 and the body-side coupler 106 to be substantially not separated from each other. This prevents the coupler assembly from being inadvertently separated due to the weight acting on the bag or other movement. Instead, in order to separate the bag-side coupler 104 from the body-side coupler 106, the user can directly manipulate the bag-side coupler 104 and the body-side coupler 106 by hand. In addition, the foldable membrane 108 allows the user to move the body-side coupler 106 slightly away from the abdominal wall 502 to allow access to the body-side coupler 106. In one aspect of the present disclosure, the body-side coupler 106 may have a protrusion (similar to a protrusion) extending radially from the concave receiving portion 206. Fig.10 In use, the user can manipulate the tab and the flange 512 of the bag-side coupler 104 with one hand to separate the bag-side coupler 104 from the body-side coupler 106.

[0059] In other words, when the bag 514 is pulled or otherwise exerts a tensile force F1, the separation force 702 is increased as the locking shelf 306 is biased toward the locking edge 202, as described herein, compared to the separation force 702 required when the ostomate separates the bag-side coupler 104 from the body-side coupler 106. This increased separation force 702 allows the coupler assembly 100 to substantially prevent unintentional separation while still providing an ostomate or other user with an interface that is easy to transition from a coupled configuration to a decoupled configuration.

[0060] In another aspect of the present invention, providing the convex portion 304 on the bag side coupler 104 can couple the bag side coupler 104 to the body side coupler 106 without the need to bring the bag side coupler together (binding) when the bag side coupler 104 is pressed into the body side coupler 106. More particularly, the user often couples the bag side coupler to the body side coupler of the ostomy appliance by first engaging a portion of the bag side coupler to the body side coupler. Then, as the user's fingers work around the periphery, the user often applies pressure around the periphery of the bag side coupler to press the bag side coupler into the body side coupler. In the design of the prior art, this coupling process causes the bag side coupler to gather and converge when the user's fingers complete the periphery of the bag side coupler. This makes coupling difficult and can cause the ostomy appliance to be incompletely coupled by the user.

[0061] The present design places the convex portion 304 on the bag side coupler 104, as described herein. In addition to all the advantages discussed herein, this configuration allows the user to couple the bag side coupler 104 to the body side coupler 106 without the bag side coupler 104 converging when the user presses around the perimeter to couple the bag side coupler 104 to the body side coupler 106. More particularly, when the user presses around the perimeter of the bag side coupler 104, the convex portion 304 slides into the concave receiving portion 206. When the user presses the bag side coupler 104 around its perimeter into the body side coupler 106, this positions the convex portion 304 of the bag side coupler 104 to align with the concave receiving portion 206. This alignment of the convex portion 304 with the concave receiving portion 206 prevents the bag side coupler 104 from bunching up or converging during coupling. Therefore, the teachings of the present disclosure particularly avoid the problems of the prior art of convergence and bunching up.

[0062] refer to Fig.10 , an alternative embodiment of a body-side coupler 1000 is shown. The body-side coupler 1000 can have substantially the same female receiver 206 as discussed herein, with a locking rim 202 and a sealing wall 208. However, instead of having a foldable membrane, the body-side coupler 1000 can have a male flange 1002 molded with / molded with the female receiver 206. The male flange 1002 can be offset from a flat surface 1004 of the body-side coupler 1000.

[0063] Reference Fig.11, another embodiment of a body-side coupler assembly 1100 is shown. In this embodiment, the body-side coupler 1102 may have a substantially identical concave receiving portion 206 as discussed herein, with a locking rim 202 and a sealing wall 208 similar to the other embodiments considered herein. However, rather than having a foldable membrane or convex flange, the coupler assembly 1100 may have a coupler flange 1104 extending from one or both sides of the concave receiving portion 206. The coupler flange 1104 may provide a location for the body-side coupler 1102 to couple to an underlying sheet 1106, which in turn may have an adhesive that couples to an ostomate.

[0064] The coupling flange 1104 can extend sufficiently away from the body side coupling 1102 to allow a weld assembly 1108 to be positioned along the outer surface of the coupling flange 1104 to selectively weld the outer flange 1104 to the underlying sheet 1106. The weld assembly 1108 can be an ultrasonic weld assembly that can be positioned along the coupling flange 1104 to provide a weld thereto to sufficiently couple the concave receiving portion 206 to the sheet 1106.

[0065] Although the welding assembly 1108 is discussed herein, the body side coupling 1102 may be coupled to the sheet 1106 by adhesive or other known coupling methods. In addition, although the coupling flange 1104 is shown on either side / both sides of the concave receiving portion 206, other embodiments contemplated herein may have only one of the two shown coupling flanges 1104. In addition, other embodiments contemplated herein may not use coupling flanges at all. In this embodiment, an adhesive may be placed directly below the concave receiving portion 206 to couple the body side coupling assembly 1100 to the ostomate.

[0066] Reference Fig.12 , a method of manufacturing a coupler assembly 1200 for an ostomy appliance is shown. The method includes forming a body-side coupler defining a concave receiving portion, as shown in block 1202. The body-side coupler can be formed of polyethylene or any other known material. In addition, the body-side coupler can be formed in an injection molding process or a similar process.

[0067] In block 1204, a bag side coupler is formed that defines a convex portion that is sized to selectively couple to a concave receiving portion. The bag side coupler may be formed of EVA or the like. Additionally, the bag side coupler may be formed in an injection molding process or other similar methods.

[0068] In block 1206, the body-side coupler is coupled to the bridge ring. As discussed herein, the body-side coupler may be coupled to the bridge ring by ultrasonic welding, adhesives, or any other known coupling method.

[0069] Similarly, the bag side coupler is coupled to the ostomy bag in block 1208. The bag side coupler may be coupled to the ostomy bag by ultrasonic welding, adhesives, or any other known coupling method.

[0070] In one embodiment of block 1202, a foldable membrane can be formed in the body-side coupler between the concave receiving portion and the bridging ring. Further, in one contemplated embodiment of block 1202, the concave receiving portion and the foldable membrane are formed together in the same manufacturing step. In one aspect of this embodiment, coupling the body-side coupler to the bridging ring from block 1206 includes welding a portion of the foldable membrane to the bridging ring along the bridging ring weld.

[0071] Another aspect of the manufacturing method 1200 includes coupling an adhesive to the bridging ring to selectively couple the body-side coupler to the abdominal wall of the user. Yet another aspect of the manufacturing method 1200 includes welding the ostomy bag to a flange formed in the bag-side coupler along a bag weld. The welding method may be performed using ultrasonic welding or any other known welding technique.

[0072] The part of this manufacturing method 1200 can include forming locking edge in concave receiving portion, and forming locking shelf in convex part.Locking edge and locking shelf can be formed in molding process, or form separately afterwards.In any case, locking edge and locking shelf are formed in positions corresponding to each other, so that body side coupler and bag side coupler are basically maintained in coupling configuration.Similarly, during molding process 1204, deflectable sealing portion can be formed in convex part, and during molding process 1202, sealing wall can be formed in concave receiving portion.Deflectable sealing portion is formed in the position that can provide fluid-tight between bag side coupler and body side coupler when being in coupling configuration.In addition, deflectable sealing portion is formed in the position that allows deflectable sealing portion to provide the biasing force towards locking edge of locking shelf.

[0073] Although the present disclosure has been described with respect to at least one embodiment, the present disclosure may be further modified within the spirit and scope of the present disclosure. Therefore, the present application is intended to cover any variation, use or adaptation of the present disclosure using its general principles. In addition, the present application is intended to cover deviations from the present disclosure that fall within the known or customary practices of the field to which the present disclosure belongs and fall within the limitations of the appended claims.

Claims

1. A coupler assembly for an ostomy appliance, the coupler assembly comprising: a body-side coupler defining a concave receiving portion having a locking rim, the body-side coupler being configured to be selectively coupled to a user; as well as a bag-side coupler defining a male portion having a locking shelf, the male portion being sized to be selectively coupleable to the female receiving portion, the bag-side coupler being configured to couple to an ostomy bag; Wherein, providing a pulling force on the ostomy bag when the male portion is coupled to the female receiving portion increases the separation force required to separate the male portion from the female receiving portion by biasing the locking rim and the locking shelf toward each other.

2. The coupling assembly according to claim 1, wherein: The ostomy bag is coupled to the bag-side coupler at a position radially outward of the locking shelf with reference to the coupler through-hole.

3. The coupling assembly according to claim 2, wherein: The body-side coupler is coupled to the bridging ring at a position radially inward of the locking rim with reference to the coupler through-hole.

4. The coupler assembly of claim 1 including a foldable membrane defined in the body-side coupler between the concave receiving portion and the bridging ring weld.

5. The coupling assembly according to claim 4, wherein: The concave receiving portion and the foldable membrane are formed from the same material in the same manufacturing process.

6. The coupling assembly of claim 1 further comprising a deflectable seal defined about the male portion at a location radially inward relative to the locking shelf with reference to the coupling through hole.

7. The coupling assembly of claim 6, further comprising a sealing wall defined in the concave receiving portion, wherein when the male portion is coupled to the concave receiving portion, the deflectable sealing portion contacts the sealing wall to substantially seal the interior of the ostomy bag from the surrounding environment.

8. The coupler assembly of claim 1, further comprising a bridging ring coupled to the body-side coupler on a first side and having an adhesive on a second side configured to selectively couple to an abdominal wall of a user around a stoma.

9. The coupling assembly according to claim 1, wherein: The body-side coupler is formed from polyethylene.

10. The coupling assembly according to claim 9, wherein: The bag-side coupler is formed of EVA.

11. The coupling assembly of claim 1, wherein: The female receiving portion of the body side coupler is welded directly to the sheet.

12. The coupler assembly of claim 1, comprising a flange defined by the bag-side coupler extending radially outwardly relative to the coupler through-hole, the ostomy bag being welded to the bag-side coupler along a surface of the flange.

13. The coupling assembly of claim 1, wherein: The female receiving portion of the body-side coupler has a male flange offset from a planar surface of the female receiving portion.

14. A method of manufacturing a coupler assembly for an ostomy appliance, the method comprising: forming a body side coupler defining a concave receiving portion having a locking rim; forming a bag side coupler defining a male portion having a locking shelf, the male portion being sized to selectively couple to the female receiving portion; coupling the body-side coupler to the bridging ring; as well as coupling the bag-side coupler to an ostomy bag; wherein the male portion is coupleable to the female receiving portion in a coupled configuration, wherein providing a pulling force on the ostomy bag increases the separation force required to separate the male portion from the female receiving portion by biasing the locking rim toward the locking shelf.

15. The method of claim 14, further comprising forming a foldable membrane in the body-side coupler between the concave receiving portion and the bridging loop.

16. The method of claim 15, further comprising forming the concave receiving portion and the foldable membrane in the same manufacturing step.

17. The method according to claim 15, wherein: The step of coupling the body side coupler to the bridge loop includes welding a portion of the foldable membrane to the bridge loop along a bridge loop weld.

18. The method of claim 14, further comprising coupling an adhesive to the bridging ring to selectively couple the body-side coupler to an abdominal wall of a user.

19. The method of claim 14, further comprising welding the ostomy bag to a flange formed in the bag-side coupler along a bag weld.

20. The method according to claim 14, wherein: The locking rim and the locking shelf correspond to each other to substantially retain the body-side coupler and the bag-side coupler in a coupled configuration.

21. The method of claim 20, further comprising forming a deflectable seal in the convex portion and a sealing wall in the concave receiving portion, wherein the deflectable seal provides a fluid seal between the bag-side coupler and the body-side coupler when in a coupled configuration.

22. The method according to claim 21, wherein: The deflectable seal is positioned to provide a biasing force of the locking shelf toward the locking rim to maintain the coupled configuration.

23. The method according to claim 14, wherein: The body-side coupler and the bag-side coupler are formed by an injection molding process.

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