Ostomy barrier appliance forming station and method

Abstract

An ostomy barrier assembly device for forming a convex or concave ostomy barrier appliance is disclosed. The convex or concave ostomy barrier appliance comprises a barrier comprising a skin barrier and a backing layer formed from a thermoplastic film, and a convex insert or a concave insert attached to the backing layer. The ostomy barrier assembly device is configured to form a convexity in the barrier and attach the convex insert or a concave insert to the barrier in a single step.

Description

OSTOMY BARRIER APPLIANCE FORMING STATION AND METHODBACKGROUND

[0001] This disclosure is related to devices and methods for forming ostomy barrier appliances for attaching an ostomy pouch to a user for collecting bodily waste. Ostomy pouches can be used by patients who have had surgery such as a colostomy, ileostomy, or urostomy. Ostomy pouches typically include flat, opposing side walls secured to one another along their peripheral edges to define a collection cavity. An opening for receiving a stoma is formed in one of the side walls, and includes a securing means or system, such as an ostomy barrier appliance, to secure the pouch to the user so that body waste discharged through the stoma is received within the cavity. Ostomy barrier appliances are generally formed through a multiple stage process and simplifying the processing steps can improve the ostomy barrier appliances while reducing manufacturing cost.BRIEF SUMMARY

[0002] An ostomy barrier forming and insert assembly station is provided according to example embodiments.

[0003] In one aspect, an ostomy barrier assembly device for forming an ostomy barrier appliance is disclosed. The ostomy barrier appliance may include a barrier including a skin barrier and a backing layer formed from a thermoplastic film, and an insert, such as a convex insert or a concave insert, attached to the backing layer. The ostomy barrier assembly device may be configured to form a convexity in the barrier and attach the convex insert or the concave insert to the barrier in a single step.

[0004] In an embodiment, the ostomy barrier assembly device may include a top clamp platedefining a recess, wherein the recess defines a concave surface. The ostomy barrier assembly device may further include a bottom clamp plate positioned opposite the top clamp plate, the bottom clamp plate defining a first hole extending through the bottom clamp plate and aligned with the recess. The top clamp plate and bottom clamp plate are moveable from an open position to a fully closed position. The ostomy barrier assembly device may further include a center plug positioned to align with the recess and first hole, wherein in the fully closed position the center plug extends through the first hole in the bottom clamp plate and into the recess of the top clamp plate. The ostomy barrier assembly device may further include a control circuit configured to position the top clamp plate and the bottom clamp plate in the fully closed position. In the fully closed position, the convex insert may be supported and pressed by the center plug into the barrier to form the convexity in the barrier and attach the convex insert in the single step.

[0005] In an embodiment, the pressing of the convex insert into the barrier forms a gapless fit between the barrier and the convex insert.

[0006] In an embodiment, in the fully closed position, the center plug and convex insert may press the barrier into and against the recess in the top clamp plate.

[0007] In an embodiment, the ostomy barrier assembly device may further include a floating bottom plate positioned between the top clamp plate and the bottom clamp plate. The floating bottom plate may define a second hole extending through the floating bottom plate and aligned with the recess and first hole. The floating bottom plate may include a first top surface toward the top clamp plate. The top clamp plate and bottom clamp plate may be moveable from the open position to a partially closed position before reaching the fully closed position. In the partially closed position, the top clamp plate may rest against the floating bottom plate. The ostomy barrier assembly device may further include a spring positioned between the floating bottom plate and thebottom clamp plate. The spring may apply a biasing force against the floating bottom plate and the bottom clamp plate. In the open position and the partially closed position, the biasing force may maintain a first distance between the floating bottom plate and the bottom clamp plate. In the fully closed position, the top clamp plate may rest against the floating bottom plate overcoming the biasing force with a second distance between the floating bottom plate and the bottom clamp plate. The second distance may be less than the first distance. In the open position and partially closed position, the center plug may extend through the bottom clamp plate and into the floating bottom plate where a second top surface of the center plug does not extend past the first top surface of the floating bottom plate. In the fully closed position, the center plug may extend through the floating bottom plate and into the recess of the top clamp plate. The control circuit may be configured to position the top clamp plate and the bottom clamp plate in the partially closed position.

[0008] In an embodiment, the ostomy barrier assembly device may further include a guide member extending from the bottom clamp plate into the floating bottom plate. The guide member may maintain a predetermined maximum distance in the open position. The biasing force may move the floating bottom plate away from the bottom clamp plate and the guide member may stop the floating bottom plate at the predetermined maximum distance. Transitioning to the fully closed position the guide member may translate relative to the floating bottom plate and / or the bottom clamp plate to allow the floating bottom plate to move toward the bottom clamp plate.

[0009] In an embodiment, in the open position, the first distance is set to keep the center plug below the first top surface of the floating bottom plate.

[0010] In an embodiment, the guide member may be one of a plurality of guide members, and the plurality of guide members may align the floating bottom plate and the bottom clamp plate.

[0011] In an embodiment, the floating bottom plate may define a first spring hole, and thebottom clamp plate may define a second spring hole. The spring may be positioned within the first spring hole and the second spring hole, wherein the first spring hole and the second spring hole may hold the spring in position.

[0012] In an embodiment, the ostomy barrier assembly device may further include an elastic washer positioned on the second top surface of the center plug, wherein, in the fully closed position, the elastic washer may rest against the barrier.

[0013] In an embodiment, the convex insert may be positioned within the elastic washer and an inner circumference of the elastic washer may rest against an outer circumference of the convex insert.

[0014] In an embodiment, the ostomy barrier assembly device may further include an O-ring positioned within an annular channel of the top clamp plate. The annular channel may be positioned on a surface toward the bottom clamp plate, and wherein, in the fully closed position, the O-ring may rest against the barrier.

[0015] In an embodiment, the convex insert may be attached to the barrier by adhesive applied to the convex insert.

[0016] In one aspect, a method of forming an ostomy barrier appliance with an ostomy barrier assembly device is disclosed. The method may further include heating an ostomy barrier to above a threshold temperature, wherein the ostomy barrier includes a skin barrier adhesive and a backing layer formed from a thermoplastic film. The method may further include positioning the ostomy barrier within the ostomy barrier assembly device. The method may further include positioning a convex insert or a concave insert within the ostomy barrier assembly device, wherein the convex insert or the concave insert is in alignment with the ostomy barrier, and wherein the convex insert or the concave insert is supported by the ostomy barrier assembly device. The method may furtherinclude pressing, by the ostomy barrier assembly device, the convex insert or the concave insert against the ostomy barrier to form a convexity in the ostomy barrier and attach the convex insert to the ostomy barrier in a single step.

[0017] In an embodiment, the method may further include placing adhesive on the convex insert or the concave insert before pressing the convex insert or the concave insert against the barrier.

[0018] In an embodiment, the ostomy barrier is heated prior to positioning the ostomy barrier within the ostomy barrier assembly device.

[0019] In an embodiment, the ostomy barrier is heated after positioning the ostomy barrier within the ostomy barrier assembly device.

[0020] In an embodiment, the ostomy barrier assembly device includes a top clamp plate defining a recess, wherein the recess defines a concave surface. The ostomy barrier assembly device may further include a bottom clamp plate positioned opposite the top clamp plate. The bottom clamp plate may define a first hole extending through the bottom clamp plate and aligned with the recess. The top clamp plate and bottom clamp plate are moveable from an open position to a fully closed position. The ostomy barrier assembly device may further include a center plug positioned to align with the recess and first hole, wherein in the fully closed position the center plug may extend through the first hole in the bottom clamp plate and into the recess of the top clamp plate. Pressing, by the ostomy barrier assembly device, the convex insert against the heated ostomy barrier may include moving the ostomy barrier assembly device from the open position to the fully closed position. In the fully closed position, the convex insert may be supported and pressed by the center plug into the barrier to form the convexity in the barrier and attach the convex insert in the single step.

[0021] In an embodiment, in the fully closed position, the center plug and convex insert may press the barrier into and against the recess in the top clamp plate.

[0022] In an embodiment, the ostomy barrier assembly device may further include a floating bottom plate positioned between the top clamp plate and bottom clamp plate. The floating bottom plate may define a second hole extending through the floating bottom plate and aligned with the recess and first hole. The floating bottom plate may include a first top surface toward the top clamp plate. The top clamp plate and bottom clamp plate may be moveable from the open position to a partially closed position before reaching the fully closed position. In the partially closed position, the top clamp plate may rest against the floating bottom plate. The ostomy barrier assembly device may further include a spring positioned between the floating bottom plate and the bottom clamp plate. The spring may apply a biasing force against the floating bottom plate and the bottom clamp plate. In the open position and the partially closed position the biasing force may maintain a first distance between the floating bottom plate and the bottom clamp plate. In the fully closed position, the top clamp plate may rest against the floating bottom plate overcoming the biasing force with a second distance between the floating bottom plate and the bottom clamp plate. The second distance may be less than the first distance. Pressing, by the ostomy barrier assembly device, the convex insert against the ostomy barrier may include moving the ostomy barrier assembly device from the open position to the partially closed position and then moving from the partially closed position to the fully closed position. In the open position and partially closed position the center plug may extend through the bottom clamp plate and into the floating bottom plate where a second top surface of the center plug may not extend past the first top surface of the floating bottom plate. In the fully closed position, the center plug may extend through the floating bottom plate and into the recess of the top clamp plate.

[0023] In an embodiment, the pressing of the convex insert against the ostomy barrier may form a gapless fit between the barrier and the convex insert.

[0024] The foregoing general description and the following detailed description are examples only and are not restrictive of the present disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The benefits and advantages of the present embodiments will become more readily apparent to those of ordinary skill in the relevant art after reviewing the following detailed description and accompanying drawings, wherein:

[0026] FIG. 1 is an illustration of a two-piece ostomy pouch system, according to an embodiment of the present disclosure;

[0027] FIG. 2Ais a perspective view of an ostomy barrier assembly device in an open position, according to an embodiment of the present disclosure;

[0028] FIG. 2B is a side view of the ostomy barrier assembly device of FIG. 2A in an open position;

[0029] FIG. 3 is a perspective view of a convex insert, according to an embodiment of the present disclosure;

[0030] FIG. 4 is a perspective view of a barrier element, according to an embodiment of the present disclosure;

[0031] FIG. 5 is a method diagram to be performed by a control circuit to attach a convex insert to a barrier element, according to an embodiment of the present disclosure;

[0032] FIG. 6A is a perspective view of the ostomy barrier assembly device of FIG. 2A in an open position with the barrier and convex insert positioned in the ostomy barrier assembly device,according to an embodiment of the present disclosure;

[0033] FIG. 6B is a side view of the ostomy barrier assembly device of FIG. 2A in an open position with the barrier and convex insert positioned in the ostomy barrier assembly device;

[0034] FIG. 7A is a perspective view of the ostomy barrier assembly device of FIG. 2A in a partially closed position with the barrier and convex insert positioned in the ostomy barrier assembly device;

[0035] FIG. 7B is a side view of the ostomy barrier assembly device of FIG. 2A in a partially closed position with the barrier and convex insert positioned in the ostomy barrier assembly device;

[0036] FIG. 8A is a perspective view of the ostomy barrier assembly device of FIG. 2A in a fully closed position with the barrier and convex insert positioned in the ostomy barrier assembly device;

[0037] FIG. 8B is a side view of the ostomy barrier assembly device of FIG. 2A in a fully closed position with the barrier and convex insert positioned in the ostomy barrier assembly device;

[0038] FIG. 9A is a perspective view of the ostomy barrier assembly device of FIG. 2A in the open position with the convex insert attached to the barrier forming an ostomy barrier;

[0039] FIG. 9B is a side view of the ostomy barrier assembly device of FIG. 2Ain the open position with the convex insert attached to the barrier forming an ostomy barrier;

[0040] FIG. 10A is a perspective view of an ostomy barrier created by the ostomy barrier assembly device of FIG. 2A, according to an embodiment of the present disclosure;

[0041] FIG. 10B is a perspective view of an ostomy barrier created by the ostomy barrier assembly device of FIG. 2A, according to an embodiment of the present disclosure;

[0042] FIG. 11 is a cross-sectional view taken along cross-section line 11 of FIG. 10A; and

[0043] FIG. 12 is an illustration of a system for making ostomy barriers, according to anembodiment of the present disclosure.DETAILED DESCRIPTION

[0044] While the present disclosure is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described presently preferred embodiments with the understanding that the present disclosure is to be considered an exemplification and is not intended to limit the disclosure to the specific embodiments illustrated. The words “a” or “an” are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular. The words “first,” “second,” “third,” and the like may be used in the present disclosure to describe various information, such information should not be limited to these words. These words are only used to distinguish one category of information from another. The directional words “top,” “bottom,” up,” “down,” front,” “back,” and the like are used for purposes of illustration and as such are not limiting. Depending on the context, the word “if’ as used herein may be interpreted as “when” or “upon” or “in response to determining.”

[0045] Ostomy pouches for collecting body waste are used by patients who have had surgery such as a colostomy, ileostomy, or urostomy. Ostomy pouches typically include flat, opposing side walls secured to one another along their peripheral edges to define a collection cavity for collecting body waste. An opening for receiving a stoma may be formed in one of the side walls. A securing means, such as an ostomy barrier (also referred to herein as “ostomy barrier appliance”), may be provided to secure the pouch to the user. The ostomy barrier attaches the ostomy pouch to the user and prevents bodily waste from leaking out between the stoma and the ostomy pouch.

[0046] The manufacturing process of ostomy barriers, such as convex or convex barrier appliances, typically involves multiple process steps. For example, a conventional manufacturingprocess of a convex barrier appliance can include a heating station to heat a barrier comprising a thermoformable film, a hydrocolloid, and a release liner, a forming station to form a convex shape in the barrier, and an assembly station to attach a convex insert to the preformed barrier using, for example, adhesive. The forming station can use vacuum or air pressure to form the convex shape in the barrier. Simplifying the manufacturing process to form convex or concave barrier appliances can improve the quality of the convex or concave barrier appliances, while reducing the cost of manufacturing. For example, reducing the number of stations required in the manufacturing process can reduce the risk of potential mistakes and improve manufacturing efficiency by increasing the speed at which a convex or concave barrier appliance can be formed.

[0047] The present disclosure provides an ostomy barrier assembly device and method configured to simplify the manufacturing process of a convex or concave barrier appliance. In an embodiment, the ostomy barrier assembly device (also referred to herein as “barrier forming station”, “barrier assembly station” and the like) may be configured to consolidate the multiple manufacturing steps (e.g. heating a barrier comprising a thermoformable film, a hydrocolloid, and a release liner, forming a convexity in the barrier, and attaching a convex insert or a concave insert to the barrier) into a single process step. For example, the ostomy barrier assembly device may heat a section of ostomy barrier material to a thermally formable temperature then press a convex insert or a concave insert into the barrier material to form a convex shape or a concave shape in the barrier material and attach the convex insert or the concave insert to the barrier material in a single station. This process may provide benefits compared to conventional approaches that use multiple stations / processes to form the convex or concave shape and attach the convex insert or the concave insert. For example, the single processing station may alleviate the need of a secondary processing station for assembling a convex insert or a concave insert into the barrier material aftera convex shape or a concave shape is formed in the barrier material. Additionally, this process may use a convex insert or a concave insert to form the convex shape or the concave shape in the barrier material. This may allow for an improved matching shape between the convex insert or the concave insert and barrier material providing an improved line-to-line fit without any gaps.

[0048] FIG. 1 illustrates a two-piece ostomy pouch system 100. According to example embodiments shown in FIG. 1, the ostomy pouch system 100 includes an ostomy barrier appliance 110 and an ostomy bag 120 (also refer to herein as “ostomy pouch”). The ostomy pouch 120 may include a body-side wall and a distal-side wall joined by a heat-sealed peripheral edge to form a cavity to collect bodily waste. The body-side wall may define an inlet opening 122 configure to receive a user’s stoma through which bodily waste can enter the cavity within the ostomy bag 120. In two-piece ostomy pouch systems, the body-side wall may include a pouch coupling member 124 to attach the ostomy bag 120 to an ostomy barrier appliance 110. The ostomy barrier appliance 110 may include a barrier coupling member 112 configured to engage with the pouch coupling member 124. In one-piece ostomy pouch systems, an ostomy barrier appliance may be permanently attached to the ostomy pouch around the inlet opening 122. In either two-piece ostomy pouch systems or one-piece ostomy pouch systems, the ostomy barrier appliance may include an adhesive skin barrier layer for attaching the ostomy barrier appliance 110 to a user, wherein the user’s stoma may be received through an inlet opening of the ostomy barrier appliance 110.

[0049] FIGS. 2A-9B illustrate an ostomy barrier assembly device 300 and a method 400 for assembling a convex ostomy barrier appliance 500 according to an embodiment of the present disclosure. Referring to FIGS. 2A and 2B, the ostomy barrier assembly device 300 may include a top die plate 302, a top clamp plate 306, a floating bottom plate 328, a plurality of springs 340, aplurality of guide members 342, a bottom clamp plate 344, a center plug 354, and a bottom die plate 364. The ostomy barrier assembly device 300 may be configured to perform a closing motion to move from an open position to a fully closed position by having the bottom die plate 364 move toward the top die plate 302 along axis 366. In an alternative embodiment, the top die plate 302 may move toward the bottom die plate 364 to fully close the ostomy barrier assembly device 300. For example, the bottom die plate 364 and the top die plate 302 may be part of an anvil press where one die plate 302, 364 is part of the press and the other die plate 302, 364 is part of the anvil.

[0050] The top clamp plate 306 may be attached to the top die plate 302. For example, the top die plate 302 may include bolt holes 304 that align with threaded holes 305 in the top clamp plate 306. Bolts may be used to extend through the bolt holes 304 and into threaded holes 305 in the top clamp plate 306 to bolt the top clamp plate 306 to the top die plate 302. The top clamp plate 306 may define an annular channel 312 and a recess 310, each centered on the axis 366. The axis 366 may extend through the center of the top clamp plate 306. An O-ring 314 may be positioned within an annular channel 312, where the opening of the annular channel 312 may be positioned to face toward the floating bottom plate 328. The recess 310 may define a concave surface 308 centered on the axis 366. The concave surface 308 may be shaped to match the convex shape (i.e., convexity topography) of a convex insert.

[0051] The bottom clamp plate 344 may be attached to the bottom die plate 364. For example, the bottom die plate 364 may include threaded holes that align with bolt holes 352 in the bottom clamp plate 344. Bolts may be used to extend through the bolt holes 352 and into threaded holes in the bottom die plate 364 to bolt the bottom clamp plate 344 to the bottom die plate 364. The bottom clamp plate 344 may define a through-hole 346 along the axis 366. The axis 366 may extend through the center of the bottom clamp plate 344. The bottom clamp plate 344 may bepositioned opposite the top clamp plate 306 such that closing the ostomy barrier assembly device 300 reduces the distance between the top clamp plate 306 and the bottom clamp plate 344. The through-hole 346 may align with the recess 310 in the top clamp plate 306. An annular cutout 358 may be positioned at the bottom of the through-hole 346 and may extend radially away from the axis 366. The annular cutout 358 may extend greater radially than the through-hole 346 and may extend from a bottom surface of the bottom clamp plate 344 to create a cutout at the bottom of the bottom clamp plate 344.

[0052] The center plug 354 may be positioned to rest against the bottom die plate 364 and may extend through the through-hole 346 in the bottom clamp plate 344. The center plug 354 extending through the through-hole 346 may keep the center plug 354 from moving laterally relative to the bottom clamp plate 344. The center plug 354 may include a radial protrusion 360 positioned on the bottom of the center plug 354 and resting against the bottom die plate 364. The radial protrusion 360 may be positioned within the annular cutout 358 of the bottom clamp plate 344. When the bottom clamp plate 344 is attached to the bottom die plate 364, the center plug 354 may be held in position by the radial protrusion 360 residing within the cutout 358. For example, the radial protrusion 360 may be positioned between a surface of the cutout 358 and the bottom die plate 364. As such, the surface of the cutout 358 may prevent the center plug 354 from moving away from the bottom die plate. The center plug 354 may extend along the axis 366 through and out of the bottom clamp plate 344.

[0053] The top end of the center plug 354 may include a top surface 330, a first protrusion 361, and a second protrusion 362. As shown in FIGS. 6A-9B, an elastic washer 332 may be positioned on the top surface 330. The elastic washer 332 may reside on the top surface 330 around the first protrusion 361 and second protrusion 362. The first protrusion 361 may extend from the top surface330 along the axis 366 and may be centered on the axis 366. The first protrusion 361 may be cylindrical and have an annular rounded section 356 that spans from the top of the first cylindrical protrusion 361 to the top surface 330. The annular rounded section 356 may have a topography to match the inner topography of a convex insert 322. The second protrusion 362 may extend from the top of the first protrusion 361 along the axis 366 and may be radially smaller than the first protrusion 361.

[0054] The floating bottom plate 328 may be positioned between the bottom clamp plate 344 and the top clamp plate 306. The floating bottom plate 328 may be suspended above the bottom clamp plate 344 by a plurality of springs 340. The floating bottom plate 328 may include a plurality of spring holes 334 and the bottom clamp plate 344 may include a plurality of spring holes 348. The floating bottom plate 328 may be positioned such that spring holes 334 in the floating bottom plate 328 align with the spring holes 348 in the bottom clamp plate 344. A spring 340 may be positioned such that one end of the spring 340 is within a spring hole 334 and the other end of the spring 340 is within the spring hole 348. The spring holes 334, 348 may keep the springs 340 in position as the springs 340 are compressed and expanded due to closing and opening the ostomy barrier assembly device 300. A spring biasing force generated by the plurality of springs 340 applies a force to separate the floating bottom plate 328 and the bottom clamp plate 344. As such, the spring biasing force may suspend the floating bottom plate 328 away from the bottom clamp plate 344, when the ostomy barrier assembly device 300 is not in a fully closed position.

[0055] The ostomy barrier assembly device 300 may perform a closing motion to move from the open position to the fully closed position. The bottom die plate 364 may move toward the top clamp plate 306 to position the ostomy barrier assembly device 300 in the fully closed position. In an alternative embodiment, the top die plate 302 may move toward the bottom die plate 364 toclose the ostomy barrier assembly device 300 or both die plates 364, 302 may move toward each other. In any case, as the distance between the bottom die plate 364 and the top die plate 302 decreases, the ostomy barrier assembly device 300 may reach a partially close position. In the partially closed position, the floating bottom plate 328 may be pressed against or rests against the top clamp plate 306 without pressing the floating bottom plate 328 toward the bottom clamp plate 344. The ostomy barrier assembly device 300 may then continue closing and overcome the biasing force produced by the springs 340 to cause the floating bottom plate 328 to move toward the bottom clamp plate 344. In the fully closed position, the distance or gap between the floating bottom plate 328 and the bottom clamp plate 344 is less than the distance or gap between them in the open or partially closed positions. In some aspects, the ostomy barrier assembly device 300 may reach the fully closed position when the floating bottom plate 328 rests against the bottom clamp plate 344.

[0056] The floating bottom plate 328 may define a through-hole 338 extending along the axis 366. The through-hole 338 may align with recess 310. The axis 366 may be positioned to extend through the center of the floating bottom plate 328. The center plug 354 may extend into the through-hole 338. The floating bottom plate may include a top surface 329 that may define a recess 331 for receiving an ostomy barrier 316. In any position from the open position to the partially closed position, the top of the center plug 354 (e.g., top surface 363 of second protrusion 362) may be positioned below the top surface 329 of the floating bottom plate 328. For example, in the partially closed position or any position of the ostomy barrier assembly device 300 where the floating bottom plate 328 is not being pressed towards the bottom clamp plate 344, the top of the center plug 354 may be positioned below the top surface 329 of the floating bottom plate 328. As the ostomy barrier assembly device 300 closes past the partially closed position, the center plug354 may extend through the floating bottom plate 328 and into the recess 310 of the top clamp plate 306.

[0057] The floating bottom plate 328 may include a plurality of guide holes 336 and the bottom clamp plate 344 may include a plurality of guide holes 350. The guide holes 350 may extend from the bottom of the bottom clamp plate 344 and into the bottom clamp plate 344. The guide holes 350 may be formed from two holes with different diameters. A larger radial diameter hole may extend from the bottom of the bottom clamp plate 344 and into the bottom clamp plate 344. The larger radial diameter hole may not extend entirely through the bottom clamp plate 344. A smaller radial diameter hole may extend from the bottom of the larger radial diameter hole and entirely through the bottom clamp plate 344. The plurality of guide holes 350 align with the plurality of guide holes 336.

[0058] A guide member 342 may be positioned within each guide hole 350 and may extend out of the guide hole 350 and into a guide hole 336. The plurality of guide members 342 keep the floating bottom plate 328 aligned with the bottom clamp plate 344 as the ostomy barrier assembly device 300 moves from the open position to the fully closed position and vice versa. The guide members 342 may align and attach the floating bottom plate 328 to the bottom clamp plate 344.

[0059] The guide members may include a first portion with a larger radial diameter than a second portion. The second portion may extend from the first portion. The first portion 341 may be positioned within the larger radial diameter hole and may not pass through the smaller radial diameter hole of the guide hole 336. The second portion may pass through the smaller radial diameter hole and extend into the guide hole 336 of the floating bottom plate 328. The second portion of the guide member 342 may be attached to the floating bottom plate 328. For example, the second portion may include a threaded section and the guide hole 336 may be threaded suchthat the guide member 342 may be threaded into the guide hole 336 attaching the guide member 342 to the floating bottom plate 328. In one embodiment, the guide member 342 may be a bolt with the first portion being the head of the bolt and the second portion being the shaft of the bolt.

[0060] The guide member 342 may translate within the guide hole 350. For example, the first portion of the guide member 342 may translate within the larger diameter hole. The guide members 342 may be attached to the floating bottom plate 328, and as such, the guide members 342 translate with the floating bottom plate 328. The biasing force of the springs 340 may cause the floating bottom plate 328 to move away from the bottom clamp plate 344 causing the guide members 342 to translate in the guide holes 350 until the first portion of each guide member 342 rests against the bottom of the larger diameter hole of each guide hole 350. As such, the guide members 342 may be designed to set a predetermined maximum distance dl or gap that the floating bottom plate 328 may translate away from the bottom clamp plate 344. For example, the second portion of the guide members 342 may be a predetermined distance with a threaded section of the second portion being screwed into the floating bottom plate 328 a predetermined distance. Screwing the guide members 342 a predetermined distance into the floating bottom plate 328 may set the predetermined maximum distance dl between the bottom clamp plate 344 and the floating bottom plate 328. The maximum distance dl may be adjusted to be larger or smaller based on the guide members 342. For example, the guide members 342 may be designed to have a longer or shorter second portion. As another example, a threaded section of the second portion of the guide members 342 may be designed to be unscrewed some to increase the distance dl or screwed more to decrease the distance dl (i.e., adjusting the distance from the first portion of the guide member 342 to the bottom of the floating bottom plate 328).

[0061] FIG. 6B and 7B provide side views of the ostomy barrier assembly device 300 in theopen position and partially closed position, respectively. In both of these positions, the top clamp plate 306 may not be pushing the floating bottom plate 328 toward the bottom clamp plate 344 and as such the distance between the floating bottom plate 328 and the bottom clamp plate 344 may be the maximum distance dl. At the maximum distance dl, the top surface 363 of the second protrusion 362 of the center plug 354 may be below the top surface 329 of the floating bottom plate 328.

[0062] At the maximum distance dl, the first portion of the guide member 342 may rest against the bottom of the larger diameter hole of the guide hole 350. FIG. 8B provides a side view of the ostomy barrier assembly device 300 in the fully closed position. In the fully closed position, the floating bottom plate 328 may be pressed toward the bottom clamp plate 344 and the first portion of the guide member 342 may translate through the larger diameter hole of the guide hole 350. In some aspects, the floating bottom plate 328 may rest against the bottom clamp plate 344 in the fully closed position. This translating process may allow the floating bottom plate 328 to move toward the bottom clamp plate 344. FIG. 9B provides a side view of the ostomy barrier assembly device 300 in the open position after closing, where the first portion of the guide member 342 may translate through the larger diameter hole of the guide hole 350 to rest against the bottom of the larger diameter hole.

[0063] In an alternative embodiment, the guide holes 336 and 350 may be switched and mirrored such that the guide member 342 may extend through and out of the floating bottom plate 328 and attach to the bottom clamp plate 344. In this alternative embodiment, the guide members 342 may move relative to the floating bottom plate 328 instead of relative to the bottom clamp plate 344 to allow the floating bottom plate 328 to move toward the bottom clamp plate 344. In this way, the guide members 342 may remain anchored to the bottom clamp plate 344 and thefloating bottom plate 328 may move relative to the guide members 342.

[0064] The ostomy barrier assembly device 300 may be used to press a convex insert 322 (FIG.3) into an ostomy barrier 316 (FIG. 4) to create a convex shape 502 (FIG. 10A) in the ostomy barrier 316 and form a convex ostomy barrier appliance 500 (FIG. 10A). The convex insert 322 may include a top surface 323 that is pressed against the ostomy barrier 316. The convex insert 322 may define a hole 324 through the top surface 323 and the convex insert 322 may include a dome area 325, a middle section 326, and a base 327. The base 327, middle section 326, and dome area 325 may be integrally formed together to form a convex shape. The convex insert 322 is configured to define a convexity of a convex barrier appliance (e.g., convex barrier appliance 500, FIG. 10A) when attached to an ostomy barrier 316.

[0065] A convex insert 322 may be positioned on top of the center plug 354. The center plug 354 may be designed to support the convex insert 322 as the convex insert 322 is pressed against the ostomy barrier 316. The bottom of the convex insert 322 may rest on the top surface 330 of the center plug 354. If an elastic washer 332 is used, then the convex insert 322 may be positioned within the elastic washer 332. The convex insert 322 may rest and be supported against the rounded section 356 of the first protrusion 361. The second protrusion 362 may extend within the hole 324 of the convex insert 322 to have the top surface 363 of the second protrusion 362 be level with the top of the dome area of the convex insert 322. The predetermined maximum distance dl may be set or adjusted to have the top surface 363 of the center plug be below the top surface 329 of the floating bottom plate 328. During a closing motion of the ostomy barrier assembly device 300, the top surface 363 of the second protrusion 362 and the convex insert 322 may be pressed against the ostomy barrier 316. The first protrusion 361 may support the convex insert 322 against the ostomy barrier 316.

[0066] A barrier 316 may be positioned on top of the top surface 329 of the floating bottom plate 328. In some aspects, the barrier 316 may be positioned within a recess 331 defined by the top surface 329. In some alternative aspects, there may be no recess 331 defined by the top surface 329. The barrier 316 may define a hole 318 through the barrier 316. Once the convex insert 322 and the barrier 316 are in position, the ostomy barrier assembly device 300 may be closed to press the convex insert 322 into the barrier 316. Prior to pressing the convex insert 322 into the barrier 316, an adhesive 370 (FIG. 3) may be applied to the convex insert 322 and the barrier 316 may be heated to a thermally formable temperature.

[0067] The adhesive 370 may be applied to the middle section 326 but may be applied to anywhere on the top surface 323 of the convex insert 322. The adhesive 370 may be added to the convex insert 322 at any time prior to pressing the convex insert 322 into the barrier 316. For example, the adhesive 370 may be added before placing the convex insert 322 onto the center plug 354 or the adhesive 370 may be added after placing the convex insert 322 onto the center plug 354 with the ostomy barrier assembly device 300 in the open position or in the partially closed position. The adhesive 370 may also be added after placing the convex insert 322 on the center plug and after positioning the ostomy barrier 316 on the top surface 329 of the floating bottom plate 328.

[0068] The ostomy barrier 316 may include a backing layer, a hydrocolloid, and a release liner. The backing layer may be formed form a thermoformable film. The barrier 316 may be heated to a thermally formable temperature at any time prior to pressing the convex insert 322 into the backing layer of the barrier 316. In one embodiment, the barrier 316 may be heated before positioning the barrier 316 on the top surface 329. In an alternative embodiment, the barrier 316 may be heated after placing barrier 316 on the top surface 329 with the ostomy barrier assembly device 300 in the open position or in the partially closed position. For example, the ostomy barrierassembly device 300 may include a heating element to heat the barrier 316 before pressing the convex insert 322 into the backing layer of the barrier 316. After the adhesive 370 is added and the ostomy barrier 316 is heated, the ostomy barrier assembly device 300 may press the convex insert 322 into the backing layer of the ostomy barrier 316 to form an ostomy barrier appliance 500.

[0069] The ostomy barrier assembly device 300 may include a control circuit or may be coupled to be controlled by a control circuit (e.g., control circuit 202, see FIG. 12). For example, the control circuit may control the ostomy barrier assembly device 300 to move the ostomy barrier assembly device 300 from the open position to the fully closed position and vice versa. The ostomy barrier assembly device 300 may also include sensors coupled to the control circuit. The sensors may provide data to the control circuit indicative of the position of the top clamp plate 306 and bottom clamp plate 344, temperature of the barrier 316, position of the barrier 316, position of the convex insert 322, or combinations thereof.

[0070] FIG. 5 illustrates a method 400 that may be performed by a control circuit (e.g., control circuit 202, FIG. 12) to have the ostomy barrier assembly device 300 form a convex ostomy barrier appliance (e.g., ostomy barrier appliance 500) by pressing a convex insert (e.g., convex insert 322) into an ostomy barrier (e.g., ostomy barrier 316). The method 400 may include the step of positioning 402 a convex insert 322 on the center plug 354. For example, the control circuit may be configured to instruct a device to take a convex insert 322 from an insert distributor and position the convex insert 322 on the top surface 330. The convex insert 322 may be positioned around and supported by the first protrusion 361 and the second protrusion 362 of the center plug 354. The convex insert 322 may be positioned within the elastic washer 332 on the top surface 330 of the center plug 354. In at least one aspect, an inner circumference of the elastic washer may rest againstan outer circumference of the base 327 of the convex insert 322. The elastic washer 332 may be the same thickness d2 (FIG. 2B) as the base 327 of the convex insert 322. This may provide a smooth surface to press against the bottom of the backing layer of the heated ostomy barrier 316 and may prevent the base 327 from being pressed into the heated barrier 316. In some alternative aspects, the elastic washer 332 may be removed and not used.

[0071] The method 400 may further include the step of positioning 404 a barrier 316 on the floating bottom plate 328. In one embodiment, the barrier material may be in the form of a web and the control circuit may control the web to position a section of barrier material on the floating bottom plate 328. In at least one aspect, the ostomy barrier 316 may be positioned in a recess 331 on the top surface 329 of the floating bottom plate 328.

[0072] The method 400, which may be performed via the control circuit, may include the step of heating 406 the barrier 316 to above a threshold temperature. For example, the control circuit may control a heating element to heat the barrier 316. The barrier 316 may be heated after the barrier 316 is positioned on the top surface 329 or before the barrier 316 is positioned on the top surface 329. The ostomy barrier 316 is heated to above a threshold temperature for them to be thermally formable. In at least one aspect, the threshold temperature may be 60°C, 80°C, 100°C, or etc. In any case, the temperature threshold is based on the material of the ostomy barrier 316. In one embodiment, the control circuit may control the heating element to heat the ostomy barrier 316 for a threshold amount of time. For example, the threshold amount of time may cause the barrier 316 to be heated above the threshold temperature. In an alternative embodiment, the control circuit may receive temperature data from a temperature sensor and control the heating element to heat the barrier 316 based on the temperature data. For example, the temperature data may be indicative of the temperature of the barrier elements and the heating elements may heat the barrier316 to above the threshold temperature.

[0073] While the method 400 illustrates the convex insert 322 being positioned before the ostomy barrier 316, the convex insert 322 may be positioned after the ostomy barrier 316. In at least one alternative embodiment, the convex insert 322 may be positioned to slide under the heated barrier 316 to reach the center plug 354. In another alternative embodiment, the heated barrier 316 may be raised or the bottom die plate 364 lowered to allow room for the convex insert 322 to be positioned on the center plug 354.

[0074] The method 400 may further include the step of placing 408 adhesive on the convex insert 322. As shown in FIG. 3, adhesive 370 is positioned on the convex insert 322 prior to the convex insert 322 being pressed against the heated ostomy barrier 316. The control circuit may be configured to control an adhesive dispenser to apply adhesive 370 to a desired area (e.g., middle section 326) on the convex insert 322. The adhesive 370 may be applied after the convex insert 322 is positioned on the center plug 354 or before the convex insert 322 is positioned on the center plug 354.

[0075] The method 400 may further include the step of moving 410 the top clamp plate 306 and bottom clamp plate 344 to position the ostomy barrier assembly device 300 from the open position to the partially closed position. For example, the control circuit may be configured to control the ostomy barrier assembly device 300 to move the bottom die plate 364 toward the top die plate 302, move the top die plate 302 toward the bottom die plate 364, or move both the top die plate 302 and bottom die plate 364 toward each other. The movement of the bottom die plate 364 and / or the top die plate 302 may position the ostomy barrier assembly device 300 in the partially closed position. FIGS. 6Aand 6B illustrate the ostomy barrier assembly device 300 in the open position with the heated ostomy barrier 316 and the convex insert 322 positioned therein.FIGS. 7A and 7B illustrate the ostomy barrier assembly device 300 in the partially closed position. In the partially closed position, the top clamp plate 306 may rest against the floating bottom plate 328 and the O-ring 314 may rest against the top surface of the heated barrier 316. In the partially closed position, the top clamp plate 306 may not be pressing the floating bottom plate 328 toward the bottom clamp plate 344. In at least one aspect, the adhesive 370 may be applied to the convex insert 322 with the ostomy barrier assembly device 300 in the partially closed position.

[0076] In the open position and the partially closed position, the top of the convex insert 322 may be positioned below the heated barrier 316 and not be pressed into the heated barrier 316. As discussed previously, the guide members 342 may be set or adjusted to get a maximum distance dl between the bottom clamp plate 344 and the floating bottom plate 328. The maximum distance dl may be set to allow the convex insert 322 to be positioned below the heated ostomy barrier 316 without touching the heated barrier 316. For example, the guide members 342 may extend from the bottom clamp plate 344 and be threaded into the floating bottom plate 328, where the length of the guide member 342 may set the maximum distance dl between the bottom clamp plate 344 and the floating bottom plate 328.

[0077] The method 400 may further include the step of moving 412 the top clamp plate 306 and bottom clamp plate 344 to position the ostomy barrier assembly device 300 from the partially closed position to the fully closed position. For example, the control circuit may be configured to control the ostomy barrier assembly device 300 to position the ostomy barrier assembly device 300 in the closed position. As the ostomy barrier assembly device 300 moves from the partially closed position to the fully closed position, the biasing force of the spring 340 may be overcome and the floating bottom plate 328 may be moved toward the bottom clamp plate 344. As such, in the partially closed position and the fully closed position, the top clamp plate 306 may be pressedagainst the floating bottom plate 328. The movement of the floating bottom plate 328 toward the bottom clamp plate 344 may cause the center plug 354 to press the convex insert 322 and the second protrusion 362 of the center plug 354 into the backing layer of the heated barrier 316. During this pressing, the O-ring 314 may rest against the top surface of the heated barrier 316 maintaining the heated barrier 316 in position. In the fully closed position, the distance between the floating bottom plate 328 and the bottom clamp plate 344 may be less than the maximum distance dl. In some aspects in the fully closed position, the floating bottom plate 328 may rest against the bottom clamp plate 344.

[0078] FIG. 8 A and 8B illustrate the ostomy barrier assembly device 300 in the fully closed position. In the fully closed position, the convex insert 322 and the second protrusion 362 may press the heated barrier 316 into the recess 310 of the top clamp plate 306. The convex insert 322 and the second protrusion 362 may be pressed into the backing layer of the heated ostomy barrier 316 to form the convex shape 502. In the fully closed position, the elastic washer 332 and the base 327 of the convex insert 322 may press against the bottom of the heated ostomy barrier 316. Additionally, in the fully closed position, the dome area 325 and middle section 326 of the convex insert 322 and the second protrusion 362 may press the heated barrier 316 against the concave surface 308 of the recess 310 in the top clamp plate 306. The heated barrier 316 may be at a high enough temperature during the pressing to allow the shape of the heated barrier 316 to change forming the convex shape 502 in the heated barrier 316.

[0079] The convex insert 322 may be attached to the heated ostomy barrier 316 during the pressing. For example, the adhesive 370 may attach the convex insert 322 to the heated ostomy barrier 316 through the contact of pressing the top surface 323 of the convex insert 322 against the heated barrier 316. The heated barrier 316 with the attached convex insert 322 may form an ostomybarrier appliance 500.

[0080] The method 400 may further include the step of moving 414 the top clamp plate 306 and bottom clamp plate 344 to position the ostomy barrier assembly device 300 from the fully closed position to the open position. The movement of the bottom die plate 364 and / or the top die plate 302 may position the ostomy barrier assembly device 300 in the open position. The method 400 may further include step of moving 416 the formed ostomy barrier appliance 500 away from the floating bottom plate 328. In one embodiment, the barrier material may be in the form of a web and the control circuit may control the web to move the formed ostomy barrier appliance on the web out of the ostomy barrier assembly device 300. The formed ostomy barrier appliance on the web may then be moved to other systems, for example, a system to print on the formed ostomy barrier appliance and / or a system to cut the formed ostomy barrier appliance out of the web.

[0081] FIGS. 10A-11 illustrate a convex ostomy barrier appliance 500 formed using the ostomy barrier assembly device 300 and the method 400 according to an embodiment. The convex ostomy barrier appliance 500 may include a convex shape 502 defined in the barrier 316 with the convex insert 322 attached thereto. Referring to Fig. 11, the convex ostomy barrier appliance 500 may have an improved line to line fit (i.e., gapless fit) between the convex insert 322 and the barrier 316 due to the convex insert 322 being used to form the convex shape 502 in the barrier 316 and attach to the barrier 316 in the same pressing motion (i.e., a single step). The convex insert 322 may be positioned within the ostomy barrier appliance 500 such that hole 318 of the barrier 316 is aligned with the hole 324 of the convex insert 322. In use, the stoma of a user may be positioned through the holes 324 and 318 in the convex ostomy barrier appliance 500. The convex ostomy barrier appliance 500 may be used with a two-piece (e.g., by adding a pouch coupling member) or a one-piece ostomy pouch.

[0082] In other embodiments, the ostomy barrier assembly device and method may be configured for assembling a concave barrier appliance, which is similar to the convex barrier appliance except the convex insert is replaced with a concave insert.

[0083] FIG. 12 illustrates an example ostomy barrier production system 200 for manufacturing convex ostomy barrier appliances 500, according to an embodiment. The ostomy barrier production system 200 may include a heating system 212, an assembly and forming system 218, a printing system 224, a cutting system 230, and a control circuit 202. The ostomy barrier production system 200 may feed a web 244 of barrier material including a thermoformable film, a hydrocolloid, and a release liner through the heating system 212, the assembly and forming system 218, the printing system 224, and the cutting system 230 to form a convex ostomy barrier appliance 500.

[0084] The control circuit 202 may include a processor 204 and a memory 206, the memory including instructions that are executed by the processor 204 to perform various functions. In some embodiments, the control circuit 202 may include a plurality of processors and a plurality of memory. In an alternative embodiment, the control circuit 202 may be a plurality of control circuits communicable coupled together. The control circuit 202 may be communicably coupled to the heating system 212, the assembly and forming system 218, the printing system 224, and the cutting system 230.

[0085] The control circuit 202 may additionally be coupled with motors to control the overall tension and movement of the web 244. For example, the control circuit 202 may control the motors to move the web 244. The control circuit 202 may move the web 244 into the heating system 212 to heat the web 244 to a formable temperature. For example, the heating element 214 may heat a section of the web 244 to be above a threshold temperature to be formable. In at least one aspect,the threshold temperature may be 60°C, 80°C, 100°C, or any other temperature based on the material of the web 244. As discussed previously regarding FIG. 5, the control circuit 202 controls the heating elements 214 to heat the section of the web 244. In an alternative embodiment, the heating system 212 may be part of the assembly and forming system 218. For example, the assembly and forming system 218 may include a heating element 214 to heat the web 244.

[0086] Once the section of web is heated to above the threshold temperature, the control circuit 202 may move the section of web 244 into position within the assembly and forming system 218. The ostomy barrier assembly device 300 is one example of an assembly and forming system 218. The control circuit 202 may be configured to control positioning of a convex insert 322 in the assembly and forming system 218. The assembly and forming system 218 may include sensors that provide sensor data indicative of the position of the convex insert 322 and the heated section of web 244. The control circuit 202 may receive this sensor data and control the assembly and forming system 218 based on the sensor data. The control circuit 202 may be configured to control application of an adhesive 370 on the convex insert 322. In one aspect, the adhesive 370 may be applied on the convex insert 322 after the convex insert 322 is positioned within the assembly and forming system 218. In an alternative aspect, the adhesive 370 may be applied on the convex insert 322 prior to positioning the convex insert 322 within the assembly and forming system 218. The convex insert 322 may be positioned on a press of the assembly and forming system 218. The heated section of web 244 may be positioned between the convex insert 322 and an anvil 220 of the assembly and forming system 218. The control circuit 202 may be configured to control the assembly and forming system 218 to perform a closing motion to move from an open position to a fully closed position. Moving toward the fully closed position may cause the press 222 to move the convex insert 322 toward the heated section of web 244 and anvil 220. In the fully closedposition, the press 222 may have pressed the convex insert 322 against the heated section of web 244 and the heated section of web 244 against anvil 220. This process causes the convex insert 322 to form a convex shape in the heated section of web 244 and attach the convex insert 322 to the heated section of web 244 using the adhesive 370 in a single step with a single device. The heated section of web 244 joined together with the convex insert 322 may form an ostomy barrier appliance 500 on the web 244. The control circuit 202 may control the assembly and forming system 218 to move from the fully closed position to the open position. Then the control circuit 202 may control the movement of the web 244 to move the ostomy barrier appliance 500 out of the assembly and forming system 218.

[0087] The control circuit 202 may control the movement of the web 244 to move the ostomy barrier appliance 500 into position within the printing system 224. The printing system 224 may include a print head 226. The control circuit 202 may control the printing system 224 to print instructional illustrations or graphics on the ostomy barrier appliance 500. For example, the ostomy barrier appliance 500 may rest on a platen or anvil and the print head 226 may print onto a surface of the ostomy barrier appliance 500 (e.g. on the release liner of the ostomy barrier appliance 500). The instructional illustrations or graphics may be instructions or designs to help a user use the ostomy barrier appliance 500.

[0088] Once the ostomy barrier appliance 500 has been printed on, the control circuit 202 may control the movement of the web 244 to move the ostomy barrier appliance 500 into position within the cutting system 230. The cutting system 230 may include a cutting element 232. The cutting system 230 may include sensors for positioning the ostomy barrier appliance 500 within the cutting system 230. For example, the control circuit 202 may receive positioning data from a sensor to allow the control circuit 202 to position the ostomy barrier appliance 500 to the properposition for cutting. The control circuit 202 may then control the cutting system 230 to cause the cutting element 232 to cut the ostomy barrier appliance 500 out of the web 244. The control circuit 202 may then control the cutting system 230 to move the ostomy barrier appliance 500 away from the web 244 and out of the cutting system 230. After the ostomy barrier appliance 500 is cut away, the control circuit 202 may control the movement of the web 244 to move the remaining web 244 out of the cutting system 230.

[0089] From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present disclosure. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should be inferred. The disclosure is intended to cover by the appended claims all such modifications as fall within the scope of the claims.

[0090] Instructions used to program logic to perform various disclosed aspects can be stored within a memory in the system such as dynamic random access memory (DRAM), cash, flash memory, or other storage. Furthermore, the instructions can be distributed via network or by way of other computer readable media. Thus a machine- readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but is not limited to, floppy diskettes, optical disks, compact disc, read-only memory (CD-ROMS), and magneto-optical disks, read-only memory (ROMS), random access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic or optical cards, flash memory, or a tangible, machine-readable storage used in the transmission of information over the internet via electrical, optical, acoustical, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Accordingly, the non-transitory computer-readable medium includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).

[0091] As used in any aspect herein, the term “control circuit” may refer to, for example, hardwired circuitry, programmable circuitry (e g., a computer processor including one or more individual instruction processing cores, processing unit, processor, microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic device (PLD), programmable logic array (PLA), or field programmable gate array (FPGA)), state machine circuitry, firmware that stores instructions executed by programmable circuitry, and any combination thereof. The control circuit may, collectively or individually, be embodied as circuitry that forms part of a larger system, for example, an integrated circuit (IC), an application-specific integrated circuit (ASIC), a system on-chip (SoC), desktop computers, laptop computers, tablet computers, servers, smart phones, etc. Accordingly, as used herein “control circuit” includes, but is not limited to, electrical circuitry having at least one discrete electrical circuit, electrical circuitry having at least one integrated circuit, electrical circuitry having at least one application specific integrated circuit, electrical circuitry having forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program which at least partially carries out processes and / or devices described herein, or a microprocessor configured by a computer program which at least partially carries out processes and / or devices described herein), electrical circuitry forming a memory device (e.g., forms of random access memory), and / or electrical circuitry forming a communications device (e.g., a modem, communications switch, or optical-electrical equipment). Those having skill in the art will recognize that the subject matter described herein may be implemented in an analog or digital fashion or some combination thereof.

Claims

CLAIMSWhat is claimed is:

1. An ostomy barrier assembly device for forming an ostomy barrier appliance, wherein the ostomy barrier appliance comprises:a barrier comprising a skin barrier and a backing layer formed from a thermoplastic film; anda convex insert or a concave insert attached to the backing layer;wherein the ostomy barrier assembly device is configured to form a convexity in the barrier and attach the convex insert or the concave insert to the barrier in a single step.

2. The ostomy barrier assembly device of claim 1, comprising:a top clamp plate defining a recess, wherein the recess defines a concave surface;a bottom clamp plate positioned opposite the top clamp plate, the bottom clamp plate defining a first hole extending through the bottom clamp plate and aligned with the recess, and wherein the top clamp plate and bottom clamp plate are moveable from an open position to a fully closed position;a center plug positioned to align with the recess and first hole, wherein in the fully closed position the center plug extends through the first hole in the bottom clamp plate and into the recess of the top clamp plate; anda control circuit configured to position the top clamp plate and the bottom clamp plate in the fully closed position, wherein in the fully closed position the convex insert is supported and pressed by the center plug into the barrier to form the convexity in the barrier and attach the convexinsert in the single step.

3. The ostomy barrier assembly device of claim 2, wherein the pressing of the convex insert into the barrier forms a gapless fit between the barrier and the convex insert.

4. The ostomy barrier assembly device of claim 2 or 3, wherein in the fully closed position, the center plug and convex insert press the barrier into and against the recess in the top clamp plate.

5. The ostomy barrier assembly device of any one of claims 2-4, comprising:a floating bottom plate positioned between the top clamp plate and the bottom clamp plate, the floating bottom plate defining a second hole extending through the floating bottom plate and aligned with the recess and first hole, the floating bottom plate including a first top surface toward the top clamp plate, wherein the top clamp plate and bottom clamp plate are moveable from the open position to a partially closed position before reaching the fully closed position, and wherein in the partially closed position the top clamp plate rests against the floating bottom plate;a spring positioned between the floating bottom plate and the bottom clamp plate, wherein the spring applies a biasing force against the floating bottom plate and the bottom clamp plate, wherein in the open position and the partially closed position, the biasing force maintains a first distance between the floating bottom plate and the bottom clamp plate, wherein in the fully closed position, the top clamp plate rests against the floating bottom plate overcoming the biasing force with a second distance between the floating bottom plate and the bottom clamp plate, and wherein the second distance is less than the first distance;wherein in the open position and partially closed position, the center plug extends throughthe bottom clamp plate and into the floating bottom plate where a second top surface of the center plug does not extend past the first top surface of the floating bottom plate, and wherein in the fully closed position, the center plug extends through the floating bottom plate and into the recess of the top clamp plate; andwherein the control circuit is configured to position the top clamp plate and the bottom clamp plate in the partially closed position.

6. The ostomy barrier assembly device of claim 5, further comprising a guide member extending from the bottom clamp plate into the floating bottom plate, the guide member maintaining a predetermined maximum distance in the open position, wherein the biasing force moves the floating bottom plate away from the bottom clamp plate and the guide member stops the floating bottom plate at the predetermined maximum distance, and wherein transitioning to the fully closed position the guide member translates relative to the floating bottom plate and / or the bottom clamp plate to allow the floating bottom plate to move toward the bottom clamp plate.

7. The ostomy barrier assembly device of claim 6, wherein, in the open position, the first distance is set to keep the center plug below the first top surface of the floating bottom plate.

8. The ostomy barrier assembly device of any one of claims 6-7, wherein the guide member is one of a plurality of guide members, and wherein the plurality of guide members align the floating bottom plate and the bottom clamp plate.

9. The ostomy barrier assembly device of any one of claims 5-8, wherein the floatingbottom plate defines a first spring hole, wherein the bottom clamp plate defines a second spring hole, and wherein the spring is positioned within the first spring hole and the second spring hole, wherein the first spring hole and the second spring hole hold the spring in position.

10. The ostomy barrier assembly device of any one of claims 5-9, further comprising an elastic washer positioned on the second top surface of the center plug, wherein, in the fully closed position, the elastic washer rests against the barrier.

11. The ostomy barrier assembly device of claim 10, wherein the convex insert is positioned within the elastic washer and an inner circumference of the elastic washer rests against an outer circumference of the convex insert.

12. The ostomy barrier assembly device of any one of claims 2-11, further comprising an O-ring positioned within an annular channel of the top clamp plate, wherein the annular channel is position on a surface toward the bottom clamp plate, and wherein, in the fully closed position, the O-ring rests against the barrier.

13. The ostomy barrier assembly device of any one of claims 1-12, wherein the convex insert is attached to the barrier by adhesive applied to the convex insert.

14. A method of forming an ostomy barrier appliance with an ostomy barrier assembly device, the method comprising:heating an ostomy barrier to above a threshold temperature, where the ostomy barrierincludes a skin barrier adhesive and a backing layer formed from a thermoplastic film; positioning the ostomy barrier within the ostomy barrier assembly device; positioning a convex insert or a concave insert within the ostomy barrier assembly device, wherein the convex insert or the concave insert is in alignment with the ostomy barrier and wherein the convex insert or the concave insert is supported by the ostomy barrier assembly device; and pressing, by the ostomy barrier assembly device, the convex insert or the concave insert against the ostomy barrier to form a convexity in the ostomy barrier and attach the convex insert or the concave insert to the ostomy barrier in a single step.

15. The method of claim 14, further comprising placing adhesive on the convex insert or the concave insert before pressing the convex insert or the concave insert against the ostomy barrier.

16. The method of any one of claims 14-15, wherein the ostomy barrier is heated prior to positioning the ostomy barrier within the ostomy barrier assembly device.

17. The method of any one of claims 14-15, wherein the ostomy barrier is heated after positioning the ostomy barrier within the ostomy barrier assembly device.

18. The method of any one of claims 14-17, wherein the ostomy barrier assembly device comprises:a top clamp plate defining a recess, wherein the recess defines a concave surface;a bottom clamp plate positioned opposite the top clamp plate, the bottom clamp platedefining a first hole extending through the bottom clamp plate and aligned with the recess, and wherein the top clamp plate and bottom clamp plate are moveable from an open position to a fully closed position;a center plug positioned to align with the recess and first hole, wherein in the fully closed position the center plug extends through the first hole in the bottom clamp plate and into the recess of the top clamp plate; andwherein pressing, by the ostomy barrier assembly device, the convex insert against the heated ostomy barrier comprises moving the ostomy barrier assembly device from the open position to the fully closed position, and wherein, in the fully closed position, the convex insert is supported and pressed by the center plug into the barrier to form the convexity in the barrier and attach the convex insert in the single step.

19. The method of claim 18, wherein in the fully closed position, the center plug and convex insert press the barrier into and against the recess in the top clamp plate.

20. The method of claim 18 or 19, wherein the ostomy barrier assembly device comprises:a floating bottom plate positioned between the top clamp plate and bottom clamp plate, the floating bottom plate defining a second hole extending through the floating bottom plate and aligned with the recess and first hole, the floating bottom plate including a first top surface toward the top clamp plate, wherein the top clamp plate and bottom clamp plate are moveable from the open position to a partially closed position before reaching the fully closed position, and wherein in the partially closed position the top clamp plate rests against the floating bottom plate;a spring positioned between the floating bottom plate and the bottom clamp plate, wherein the spring applies a biasing force against the floating bottom plate and the bottom clamp plate, wherein in the open position and the partially closed position the biasing force maintains a first distance between the floating bottom plate and the bottom clamp plate, wherein in the fully closed position, the top clamp plate rests against the floating bottom plate overcoming the biasing force with a second distance between the floating bottom plate and the bottom clamp plate, and wherein the second distance is less than the first distance;wherein pressing, by the ostomy barrier assembly device, the convex insert against the ostomy barrier comprises moving the ostomy barrier assembly device from the open position to the partially closed position and then moving from the partially closed position to the fully closed position, wherein in the open position and partially closed position the center plug extends through the bottom clamp plate and into the floating bottom plate where a second top surface of the center plug does not extend past the first top surface of the floating bottom plate, and wherein in the fully closed position the center plug extends through the floating bottom plate and into the recess of the top clamp plate.

21. The ostomy barrier assembly device of any one of claims 14-21, wherein the pressing of the convex insert or the concave insert against the ostomy barrier forms a gapless fit between the barrier and the convex insert or the concave insert.

Images