Coupling system for an ostomy appliance

Abstract

The invention relates to a coupling assembly for an ostomy appliance having a pouch side flange having a pouch and an integrated member having a concertina diaphragm and a body side flange, the integrated member being configured to be selectively coupled to the pouch side flange. The integrated member is formed in a single manufacturing process.

Description

[0001] Cross-references to related applications

[0002] This disclosure claims the benefit of U.S. Patent Application No. 63 / 132,806, filed December 31, 2020, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] This invention relates to an ostomy connector / link for removably attaching / linking an ostomy appliance to a body fitting worn on the body of an ostomy patient, and more particularly to providing a body fitting with a floating connector. Background Technology

[0004] This invention relates to a device attached to a patient's body after undergoing a surgical stoma procedure to address their gastrointestinal problems. The various issues they experience disrupt their body's normal processes for handling and collecting waste products from digestion. These patients, known as stoma patients, typically require wearing and maintaining these waste collection devices for the rest of their lives. Essentially, the device generally comprises an adhesive "ring" surrounding the abdominal stoma outlet. The adhesive component adheres to the patient on one side and to a collection bag on the other. The purpose of this system is to provide a fluid and reasonably airtight seal during the procedure, allowing stoma patients to enjoy an active and social life.

[0005] U.S. Patent Nos. 4,419,100, 4,610,676, 4,610,677, 5,730,735, 5,312,382, 8,366,695 (hereinafter referred to as the “695 Patent”), and 8,382,732 (hereinafter referred to as the “732 Patent”) teach an ostomy connector designed to reduce discomfort experienced by ostomy patients due to adhesion forces exerted on the skin by the body fitting component when the two connecting parts are pressed together. Discomfort during postoperative care is particularly important when the ostomy is recent and the abdominal skin is very soft. These documents teach a flexible collar suspension device permanently fixed between the connecting parts of the adhesive base / disc and the body fitting component. The flexible collar allows the connecting portion to be removed from or "float" relative to the adhesive base, at least by a sufficient amount of movement, so that the user can insert one or more fingers behind the connecting portion to manually support it against adhesion forces when the appliance presses against the body mating parts. Such a connecting portion is commonly referred to in the art as a floating connecting portion.

[0006] Typically, these ostomy devices are designed so that the collection bag can be separated from the adhesive component via a connecting flange. This allows a new bag to be reattached without damaging the underlying adhesive ring. This extends the lifespan of the adhesive component, reduces costs, and minimizes skin irritation from frequent adhesive component replacements. Products with this construction are often referred to as "two-piece" ostomy devices.

[0007] Another drawback of the typical design is that the force required to separate and reconnect the flanges acts directly on the patient's abdomen. '695 and '732 patents taught a two-piece ostomy device designed to reduce discomfort for many ostomy patients caused by the attachment and separation forces applied through the connector.

[0008] The '695 patent design focuses on the period of particular swelling and sensitivity of the wound after initial surgical care. During this time, doctors and postoperative staff will care for the patient. The connector is fixed at an extended distance away from the patient. This provides caregivers with space to easily support the connector during disassembly and reattachment, thereby isolating forces from the patient's abdomen.

[0009] The '732 patent addresses a situation that arises in more common, normal daily life when patients wear collection devices after the surgical recovery period. The connector can be temporarily extended (or "floated") by a flexible membrane. This improves accessibility for maintenance by allowing the wearer space to insert one or more fingers behind the connector. The wearer can support and insulate against reaction forces that allow the flange to disengage and reconnect. The connector can then be folded 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 effectively "bistable" (i.e., stable in the folded state to resist movement or sagging by an active wearer, and 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 connecting flanges are manufactured separately from the flexible membrane. The flexible membrane is then attached to both the body-side and bag-side flanges. The attachment of the flexible membrane to the body-side flange in a typical two-piece device has proven problematic. More specifically, stretchable membranes are typically produced by first extruding a thin, flat, flexible membrane made of a polyethylene copolymer, etc. The membrane is rolled up and then fed into a vacuum thermoforming operation to obtain a folded “accordion pleat” shape. The accordion pleat shape is then punched into individual pieces with the desired inner and outer diameter dimensions. The copolymer chosen for extrusion optimizes flexibility while still providing a structure with sufficient rigidity for bi-stability.

[0011] Membrane extrusions are prone to potentially incorporating small air bubbles and foreign particles, leading to pinholes that penetrate the membrane. This requires careful process control. Thermoforming processes inherently lack control over wall thickness, resulting in particularly thin walls where the membrane needs to be stretched the most. These two factors combine to create intermittent pinholes that can only be detected after sub-assemblies have been produced and leak tests have been performed.

[0012] The body-side flanges and pleated diaphragms are assembled and joined together via thermal fusion / welding to form subassemblies for further processing into finished products. Handling the diaphragms with automated assembly equipment and precisely concentrically positioning them with the flanges prior to fusion has proven challenging. Subsequent fusion operations and in-process leaks and dimensional testing are significant sources of non-recyclable waste.

[0013] This disclosure addresses these problems and other issues present in the prior art. Summary of the Invention

[0014] This disclosure allows for the integration of body side flanges and accordion-pleated diaphragms into a single component via injection molding. This eliminates the cost and complexity of producing separate thin-walled films from extruded films, followed by thermoforming and punching to produce the accordion-pleated diaphragm components. This disclosure also provides a more efficient manufacturing process that improves upon the prior art process of joining and connecting diaphragms together using separate flanges.

[0015] Using injection molding to produce flexible components allows for a wider design range. Unlike film extrusion processes, where wall thickness must be consistent, wall thickness can be optimized for different product sizes and can be further optimized within a given product size. For example, a thicker cross-sectional area can be provided where rigidity is required, while a thinner cross-sectional area can be provided where flexibility is required.

[0016] One embodiment of this disclosure is a coupling assembly for an ostomy device, the coupling assembly including a pouch side flange having a pouch and an integrated element having an accordion-pleated membrane and a body side flange, the integrated element being configured to selectively engage with the pouch side flange. This integrated element is formed in a single manufacturing process / step.

[0017] In one example of this embodiment, the single manufacturing step is an injection step / injection molding process.

[0018] In another example, the integrated element defines a deflectable / turnable seal configured to seal the integrated elements relative to the bag-side flange when they are coupled together. In a portion of this example, the deflectable seal connects an accordion-pleated diaphragm to the body-side flange. In one aspect of this portion, the deflectable seal has a first thickness at the base portion and a second thickness at the sealing portion, the second thickness being less than the first thickness. The deflectable seal transitions to the accordion-pleated diaphragm through the sealing portion. Furthermore, the accordion-pleated diaphragm has a third thickness, the third thickness being less than the first and second thicknesses. In an alternative configuration, the accordion-pleated diaphragm has a third thickness that is substantially the same as the second thickness.

[0019] In another example, the integrated element includes a bridging ring segment that is coupled to a bridging ring configured to attach to the patient's abdominal wall around the stoma using adhesive components. In a portion of this example, the integrated element is coupled to the bridging ring via a weld, and the weld between the bridging ring and the integrated element is the only weld on the integrated element.

[0020] Another embodiment is a process for manufacturing a connecting component for an ostomy appliance. The process includes: providing a mold for forming an integrated element having a bridging ring segment, an accordion-pleated diaphragm, and a body side flange; injecting material into the mold to form the integrated element in a single injection step; and removing the integrated element from the mold. The integrated element is configured such that the accordion-pleated diaphragm is deformable to allow the body side flange to transition between a retracted position and an extended position relative to the bridging ring segment.

[0021] One example of this embodiment includes fusing the integrated component to the bridging ring. A portion of this example includes attaching an adhesive component to the bridging ring, the adhesive component being configured to allow a user to selectively attach the bridging ring and the corresponding integrated component to the user's abdominal wall.

[0022] Another example of this embodiment includes forming a deflectable seal in an integrated element as part of a single injection molding process. The deflectable seal includes a base portion having a first thickness and a sealing portion having a second thickness less than the first thickness. Furthermore, the pleated diaphragm has a third thickness different from the first and second thicknesses.

[0023] Another example of this embodiment includes forming a locking protrusion in the integrated element in a single injection process.

[0024] Another embodiment of this disclosure is a method for manufacturing a coupling assembly for an ostomy device. The method includes providing a pouch-side flange configured to selectively engage with a deflectable seal around the ostomy opening, and forming an integrated element from a single material having a bridging ring segment, an accordion-pleated diaphragm, a body-side flange, and defining the deflectable seal. In this embodiment, the integrated element is configured to selectively engage the pouch-side flange with the deflectable seal of the integrated element such that the accordion-pleated diaphragm is deformable to allow the body-side flange to transition between a retracted position and an extended position relative to the bridging ring segment.

[0025] One example of this embodiment includes attaching an integrated element to a bridging ring, the bridging ring being configured to selectively attach to a user. This example may include attaching an adhesive component to the bridging ring, the adhesive component being configured to allow the user to selectively attach the bridging ring and the corresponding integrated element to the user's abdominal wall. Another example of this embodiment includes forming a locking protrusion in the integrated element in a single injection step. Attached Figure Description

[0026] The foregoing aspects of this disclosure and the ways in which they are obtained will become more apparent and the disclosure itself will be better understood from the following description, taken in conjunction with the accompanying drawings and reference to embodiments thereof, wherein:

[0027] Figure 1a This is a top view of an embodiment of the connecting assembly of a two-piece ostomy device in the retracted position;

[0028] Figure 1b yes Figure 1a A cross-sectional view of the connecting components shown;

[0029] Figure 1c yes Figure 1b Detailed view of the sectional view shown;

[0030] Figure 2a It is in an extended position. Figure 1a Top view of the connecting components shown;

[0031] Figure 2b yes Figure 2a A cross-sectional view of the connecting components shown;

[0032] Figure 2c yes Figure 2b Detailed view of the sectional view shown;

[0033] Figure 3a This is a top view of an embodiment of an improved connecting assembly of a two-piece ostomy device in the retracted position;

[0034] Figure 3b yes Figure 3aA cross-sectional view of the connecting components shown;

[0035] Figure 3c yes Figure 3b Detailed view of the sectional view shown;

[0036] Figure 4a It is in an extended position. Figure 3a Top view of the connecting components shown;

[0037] Figure 4b yes Figure 4a A cross-sectional view of the connecting components shown;

[0038] Figure 4c yes Figure 4b Detailed views of the sectional view shown; and

[0039] Figure 5 yes Figures 3a-4c A cross-sectional view of the integrated body side flange and accordion pleated diaphragm of the connecting assembly shown. Detailed Implementation

[0040] The embodiments described below are not intended to be exhaustive, nor are they intended to limit the disclosure to the exact forms described in the detailed description below. Rather, the embodiments were chosen and described so that those skilled in the art can understand and appreciate the principles and practice of the disclosure.

[0041] Figures 1a-1c A connecting assembly 100 for a two-piece stoma device is shown. The connecting assembly 100 can be selectively connected to the patient's abdominal wall 102 via an adhesive member 104, etc. More specifically, a bridging ring 106 can be connected to the adhesive member 104 on one side and fused or otherwise connected to an accordion flap 108 on the other side. The bridging ring 106 can be connected to the accordion flap 108 along a fusion region 110 that connects the accordion flap 108 to the bridging ring, which substantially completely surrounds an opening 120 configured to be positioned around a stoma 112. The accordion flap 106 can be connected to the bridging ring 106 along the fusion region 110 to substantially prevent fluid from flowing from the stoma 112 through the fusion region 110 to the surrounding environment 114 when connected to the abdominal wall 102.

[0042] exist Figures 1a-1c and Figures 2a-2c In some embodiments, the body side flange 116 may also be attached to a portion of the pleated diaphragm 108. The body side flange 116 may be attached to the pleated diaphragm 108 along a weld area 118 radially away from the weld area 110 relative to the opening 120. The weld area 118 may also extend entirely around the opening 120 to substantially prevent fluid from flowing from the stoma 112 into the surrounding environment when the bag is attached thereto.

[0043] In one aspect of this embodiment, the accordion-pleated diaphragm 108 has at least one fold between the bridging ring 106 and the body-side flange 116, allowing the body-side flange 116 to... Figures 1a-1c The retraction position and Figures 2a-2c It extends between the stretching positions. Figures 1a-1c The retracted position allows ostomy instruments to be placed as close as possible to the abdominal wall 102 during normal use. Figures 2a-2c The extended position can be used to provide the user with an inlet for connecting the component 100 so that the corresponding ostomy bag can be easily connected and disconnected.

[0044] The body side flange 116 may also have a locking protrusion 124 and a deflectable / rotatable seal 122 circumferentially defined around the body side flange 116. The locking protrusion 124 and the deflectable seal 122 may correspond to the bag side flange 126 to selectively engage the bag side flange 126 to the body side flange 116. More specifically, the locking protrusion 124 may be positioned radially outward relative to the seal 122 along the body side flange 116 and may have an inclined leading surface and a following locking surface. The bag side flange 126 may generally have a corresponding bag engaged around the opening 120 to substantially contain outflow from the stoma 112 when engaged to the body side flange 116.

[0045] When the bag-side flange 126 is engaged with the body-side flange 116, the inclined leading surface aligns with a corresponding recess in the bag-side flange 126, and the flanges 116 and 126 may transition toward each other. When the flanges 116 and 126 are aligned as shown in FIG. 1, the inclined leading surface deflects radially inward until the locking surface following it is fully located in the recess of the bag-side flange 126. Once the flanges 116 and 126 are engaged... Figures 1a-1c and Figures 2a-2c As shown, the recess of the bag side flange 126 can define a surface corresponding to the locking protrusion 124 of the body side flange 116, so as to substantially lock the flanges 116, 126 together.

[0046] The basic locking mechanism of flanges 116 and 126 means that flanges 116 and 126 are connected to each other to fundamentally prevent accidental separation of flanges 116 and 126. That is, flanges 116 and 126 are connected to prevent separation under the action of expected forces (such as when the user moves around while the corresponding bag contains fluid). However, the user may be able to overcome the basic locking mechanism using normal human force to separate flanges 116 and 126 from each other, thereby changing the corresponding bag.

[0047] The deflectable seal 122 of the body-side flange 116 can correspond to an adjacent surface in the recess of the bag-side flange 126, so that the bag-side flange 126 and the corresponding portion are substantially sealed relative to the body-side flange 116 positioned around the stoma 112. When the flanges 116, 126 are in the substantially locked configuration, the deflectable seal 122 is positioned against the corresponding surface of the bag-side flange 126, thereby sealing the flanges 116, 126 to each other around the opening 120.

[0048] In one aspect of this disclosure, when in the retracted configuration shown in FIG. 1, the pleats of the accordion-pleated diaphragm 108 may extend at least partially toward the bag-side flange 126 to be positioned radially inward of the bag-side flange 126. In this configuration, the pleats of the accordion-pleated diaphragm 108 may help maintain proper alignment of the bag-side flange 126 and the corresponding bag with the opening 120 when coupled to the body-side flange 116.

[0049] refer to Figures 2a-2c The body-side flange 116, as shown, extends from the bridging ring 106. In this configuration, the pleats in the accordion-pleated diaphragm 108 are at least partially unfolded to allow the flanges 116, 126 to be at least partially spaced from the abdomen 102. Figures 2a-2c In the extended position, flanges 116 and 126 can remain in a sealed configuration, with the locking protrusion 124 engaging in the recess of the bag-side flange 126. However, the extended position of FIG. 2 allows the user to manipulate flanges 116 and 126 with sufficient force to separate them from each other and to separate the bag-side flange 126 and the corresponding bag from the body-side flange 116. This allows the bag-side flange 126 and the bag to be replaced without the need for new adhesive parts 104, as described herein.

[0050] Now for reference Figures 3a-3c , Figures 4a-4c and Figure 5 This illustrates another embodiment of a connection component 300. This embodiment may have a connection with... Figures 1a-1c and Figures 2a-2c The embodiments have essentially the same advantages, and relative to Figures 1a-1c and Figures 2a-2c There are some improvements. More specifically, this embodiment can utilize a substantially integrated pleated diaphragm 302 and body-side flange 304 to form a single integrated element 306. This integrated element 306 can define a locking protrusion 310 and a deflectable seal 312, which is configured to lock and seal the integrated element 306 to the bag-side flange 314, similar to the reference. Figures 1a-1c and Figures 2a-2c The embodiments discussed.

[0051] In one aspect of the connecting assembly 300, the body-side flange 304 and the accordion-pleated diaphragm 302 of the integrated element 306 are formed from substantially the same material in a single manufacturing process. In this configuration, Figures 1a-1c and Figures 2a-2c The welded region 118 described herein, where the accordion diaphragm 108 is attached to the body side flange 116, is unnecessary because the body side flange 304 is formed by the accordion diaphragm 302. By manufacturing a single integrated element 306, the entire manufacturing step of welding the body side flange 116 to the accordion diaphragm 108 is eliminated. This reduces manufacturing costs and improves quality control by eliminating the complex manufacturing steps required to align the accordion diaphragm 108 with the body side flange 116 and weld the separate components together, which are necessary for connecting the assembly 100.

[0052] Other functions of the connecting assembly 300 are substantially the same as those of the connecting assembly 100. For example, the integrated component 306 can be connected to the bridging ring 316 by means of welding 318, etc. The bridging ring 316 can be connected to the adhesive component 320, which is configured to connect to the patient's abdominal wall 322. Furthermore, the accordion-pleated membrane 302 portion of the integrated element 306 allows the body-side flange 304 portion of the integrated element 306 to be positioned relative to the bridging ring 316 from... Figures 3a-3c The retraction position in the middle extends to Figures 4a-4c The extension position within the structure. Furthermore, the locking protrusion 310 and the deflectable seal 312 can correspond to the annular recess of the bag-side flange 314 to selectively engage and seal the bag-side flange 314 and the corresponding bag to the integrated element 316, thereby engaging to and sealing relative to the stoma 112 when the bridging ring 316 is engaged to the abdominal wall 322. In other words, the coupling assembly 300 can function in substantially the same manner as the coupling assembly 100, while being easier to manufacture and providing better quality control.

[0053] Now for reference Figure 5 The diagram shows an isolated cross-sectional view of the integrated element 306. As described herein, the integrated element 306 can be formed from a seamless material. That is, there is no weld between the pleated diaphragm 302 and the body-side flange 304. Instead, the pleated diaphragm 302 transitions from the bridging ring section 502 to the deflectable seal 312. The pleated diaphragm 302 can be formed from a folded material that allows the integrated element 306 to transition relative to the bridging ring 316 from... Figure 5 The retracted position extends to the extended position (e.g.) Figures 4a-4c (As shown).

[0054] The deflectable seal 312 can bridge the pleated diaphragm 302 and the body-side flange 304 to connect the parts to each other. Furthermore, the deflectable seal 312 can have a base portion 504 and a sealing portion 506. The cross-section of the deflectable seal 312 can be tapered / tapered, such that a first thickness 508 of the base portion 504 is greater than a second thickness 510 at the sealing portion 506. In this configuration, the deflectable seal 312 can have sufficient rigidity to ensure a tight seal against the corresponding bag-side flange 314 when coupled, and sufficient flexibility to ensure a substantially fluid-impermeable seal along the bag-side flange 314.

[0055] The sealing portion 506 can transition directly to the pleated diaphragm 302 without a seam. In one aspect of this disclosure, the pleated diaphragm 302 may have a third thickness 512 that is substantially the same as the second thickness 510. However, in other embodiments, the third thickness 512 of the pleated diaphragm 302 may be less than the second thickness of the sealing portion 506. Furthermore, in some embodiments contemplated herein, the third thickness 512 may be greater than the second thickness 510.

[0056] The base portion 504 may be adjacent to the locking protrusion 310 and the remainder of the body side flange 304 and made of the same material. In this way, the entire integrated element 306 can be formed in a single injection molding process. That is, the body side flange 304 and the accordion pleated diaphragm 302 can be formed in a single injection molding process without the need for the welding process required for the connecting assembly 100.

[0057] In one aspect of this disclosure, the thicknesses 508, 510, and 512 can be varied to suit different usage characteristics. For example, the thickness 512 can be increased to make the connecting assembly 300 more rigid relative to a thinner thickness 512. This can allow the connecting assembly 300 to suppress significant movement of the stoma device during user movement or when the bag is full. Alternatively, in some embodiments, the thickness 512 can be reduced to provide the connecting assembly 300 to be more easily manipulated to the extended position relative to an increased thickness at 512. Similarly, the thicknesses 508 and 510 of the base portion 504 and sealing portion 506 of the deflectable seal 310 can be varied to affect sealing performance and the ease of engagement / disengagement of the bag-side flange 314 with the body-side flange 304.

[0058] Once the thicknesses 508, 510, and 512 are determined, the mold can be designed with corresponding cavities to produce the entire integrated element 306 in a single injection molding process. That is, material can be injected into the mold to form the integrated part 306 without any additional welding or other methods. Once the integrated part 306 is formed in a single injection molding process, the bridging ring segment 502 can be attached to the bridging ring 316 along the weld area 318. While the weld area 318 is discussed here for the bridging ring segment 502 to attach the bridging ring 316 to the integrated element 306, other attachment techniques are also considered. For example, adhesive components can be used instead of a welding process. The bridging ring 316 can have an adhesive component 320 attached to it beforehand or subsequently. At this point, the integrated element 306 and the bridging ring 316 can be attached to the user, and the body-side flange 304 and the corresponding pouch can be selectively attached thereto.

[0059] In one aspect of this disclosure, the material used for injection molding to form the integrated element 306 can be low-density polyethylene. This injection molding process for the integrated element 306 eliminates the cost and complexity of producing individual thin-walled diaphragms from extruded diaphragms, followed by thermoforming and punching the diaphragms to produce the accordion-pleated diaphragm components required for the coupling assembly 100. It also eliminates the subsequent manufacturing work of joining the diaphragms with individual flanges and connecting them together.

[0060] The use of injection molding to produce flexible components allows for a wider design range. Unlike film extrusion processes, where wall thickness must be consistent, wall thickness can be optimized for different product sizes and can be further optimized within a given product size. For example, as discussed here, thicker cross-sectional areas can be provided where rigidity is required, while thinner cross-sectional areas can be provided where flexibility is required. Injection molding allows designers to manufacture integrated elements 306 with different thicknesses 508, 510, 512, etc., to suit the needs of different appliances or users. Similarly, this disclosure provides advantages over the prior art in terms of manufacturability of the connecting assembly, allowing the integrated element 306 to be adapted to specific user needs while also being practically manufactureable in other respects.

[0061] Although this disclosure has been described with respect to at least one embodiment, further modifications may be made to this disclosure within its spirit and scope. Therefore, this application is intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Furthermore, this application is intended to cover deviations from this disclosure that fall within known or customary practice in the art to which this disclosure pertains and fall within the limitations of the appended claims.

Claims

1. A coupling assembly for an ostomy appliance, comprising: a pouch side flange having a pouch; an integrated element having an accordion-style membrane and a body side flange, the integrated element configured to be selectively coupled to the pouch side flange; wherein the integrated element being formed in a single manufacturing process, wherein the integrated element defines a deflectable seal configured to seal the integrated element relative to the pouch side flange when the integrated element and the pouch side flange are coupled to one another, and wherein the deflectable seal seamlessly connects the accordion-style membrane to the body side flange.

2. The coupling assembly of claim 1, wherein, The deflectable seal has a first thickness at a base portion, a second thickness at a sealing portion, the second thickness being less than the first thickness.

3. The coupling assembly of claim 2, wherein, The deflectable seal transitions to the accordion-style membrane through the sealing portion.

4. The coupling assembly of claim 2, wherein, The accordion-style membrane has a third thickness, the third thickness being less than the first thickness and the second thickness.

5. The coupling assembly of claim 2, wherein, The accordion-style membrane has a third thickness, the third thickness being substantially the same as the second thickness.

6. The coupling assembly of claim 1, wherein, The integrated element includes a bridge ring segment coupled to a bridge ring, the bridge ring configured to be coupled with an adhesive member to an abdominal wall of a patient around a stoma.

7. The coupling assembly of claim 6, wherein, The integrated element is coupled to the bridge ring by a weld, the weld between the bridge ring and the integrated element being the only weld on the integrated element.

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