Ostomy pouch including multi-stage filter protection section

Abstract

The ostomy appliance includes a filter assembly and a multi-stage filter guard, which may include a pre-filter formed from foam and a micro-perforated guard panel covering the pre-filter.

Description

[Technical Field]

[0001] The following description relates to ostomy appliances, and more particularly to ostomy pouches that include odor filters and multi-stage filter protection. [Background technology]

[0002] Ostomy bags or pouches include an inlet configured to receive liquid, semi-solid, or solid waste discharged from the stoma for collection within the pouch. Known pouches also include a filter assembly that facilitates odor filtration and gas egress from the pouch. However, in some cases, liquid, semi-solid, or solid contents (i.e., waste) can flow into and close the filter assembly, thereby restricting gas egress through the filter assembly. This can lead to pouch ballooning caused by increased gas pressure and unwanted expansion of the pouch. Summary of the Invention [Problem to be solved by the invention]

[0003] The degradation of quality of life from pouch ballooning can be significant for ostomates, including anxiety, lack of caution, fear of leakage, nighttime attention, and inconvenient user intervention to relieve gas pressure. Common methods for releasing accumulated gas include opening the pouch connection system, often referred to as "burping," draining the pouch, and peeling the skin barrier. Many ostomates report spending time dealing with pouch ballooning issues and feeling resigned to their current ostomy pouch systems.

[0004] Therefore, it would be desirable to provide an improved ostomy pouch system that minimizes ballooning while still providing equal or better odor filtration. [Means for solving the problem]

[0005] In one embodiment, an ostomy pouch is provided that includes a filter assembly and a multi-stage filter guard. The ostomy pouch can include a body-side wall and a distal-side wall joined at an outer periphery and defining an interior volume including a collection area. The ostomy pouch can further include an inlet for receiving ostomy waste and an outlet for gas collected in the collection area to exit. The filter assembly can be positioned to cover the outlet. The multi-stage filter guard can be configured to protect the filter assembly and can include a pre-filter and a protective panel that covers the pre-filter.

[0006] In one embodiment, the filter assembly can be attached to the exterior surface of one of the body-facing wall and the distal wall, and the multi-stage protection portion can be located inside the pouch. For example, the filter assembly can be attached to the exterior surface of the distal wall, and the pre-filter and protection panel can be attached to the interior surface of the distal wall. In other embodiments, the filter assembly and multi-stage protection portion can be located inside the pouch.

[0007] The protective panel can be formed from a microperforated film, an embossed film, or a microperforated embossed film. In one embodiment, the protective panel can be formed from a microperforated film containing a plurality of openings having a diameter of about 100 μm to about 500 μm, and the plurality of openings can be arranged to provide a pore density of about 25 ppi to about 300 ppi. The protective panel can be sealed to the distal sidewall and / or the body-facing sidewall along an outer peripheral seal. The plurality of openings can be provided in a portion of the protective panel or throughout the entire surface of the protective panel. For example, the plurality of openings can be provided in the lower or upper portion of the protective panel.

[0008] In one embodiment, the protective panel can be formed from a microperforated film including a first set of microperforations including a plurality of openings having a diameter of about 300 μm to about 500 μm and a second set of microperforations including a plurality of openings having a diameter of about 50 μm to about 200 μm, where the first set of microperforations can be positioned adjacent to the lower periphery of the protective panel and the second set of microperforations can be positioned above the first set of microperforations. In such an embodiment, the first set of microperforations can be configured to allow ostomy output accumulated between the protective panel and the pouch wall to flow down to a collection area. The second set of microperforations can be provided across at least about 30% of the protective panel area with a pore density of about 100 ppi to about 200 ppi to allow gas to flow through the protective panel even after some of the microperforations are closed by ostomy output.

[0009] The protective panel can be sealed to the distal sidewall along its lower periphery to provide a horizontal seal. A portion of the protective panel adjacent the filter assembly can be free of microperforations. The horizontal seal can be a discontinuous heat seal, or the protective panel can include at least one slit or opening adjacent the lower periphery configured to allow liquid that accumulates between the protective panel and the distal sidewall to drain into the collection area.

[0010] In one embodiment, the prefilter can include a first layer formed from a reticulated or open-cell foam. For example, the first layer can be formed from a reticulated polyurethane (PU) foam. In some embodiments, the prefilter can also include a second layer. In such embodiments, the first layer can be laminated to the second layer, and the prefilter can be attached to the distal wall by heat-sealing the second layer to the inner surface of the distal wall. The second layer can be formed from a polyester nonwoven or a spunbond-meltblown-spunbond polypropylene (SMS PP) nonwoven.

[0011] In one embodiment, the filter assembly can include a membrane layer, a backing layer, and a filter media disposed between the membrane layer and the backing layer. The filter assembly can be attached to the exterior surface of one of the body-side wall and the distal-side wall, or to the interior surface of one of the body-side wall and the distal-side wall, with the membrane layer covering the outlet. The backing layer can be formed from a low-density polyethylene film. The filter media can be formed from an activated carbon-impregnated foam, which can be hydrophobic. In one embodiment, the filter media can be formed from an activated carbon reticulated PU foam. The membrane layer can be formed from an SMS PP nonwoven fabric. In one embodiment, the SMS PP nonwoven fabric can have a basis weight of about 40 gsm to about 80 gsm.

[0012] In one embodiment, the filter assembly can be configured to provide a radial gas flow path through the filter media. In such an embodiment, the filter assembly can be configured to direct gas exiting through the pouch outlet to flow through the membrane layer, flow radially through the filter media, and exit the filter assembly through at least one gas outlet located proximate the outer periphery of the filter assembly.

[0013] In one embodiment, the filter assembly and multi-stage guard can be constructed and arranged to allow gas collected in the collection area to flow through the microperforations in the guard panel, through the pre-filter, exit the ostomy bag through the outlet, flow through the membrane layer, be filtered through the filter media, and then exit the filter assembly.

[0014] In another embodiment, the filter assembly and multi-stage guard can be constructed and arranged to allow gas collected in the collection area to flow through the microperforations in the guard panel, through the pre-filter, radially through the filter media, and through the membrane layer before exiting the ostomy pouch through the outlet.

[0015] Other objects, features, and advantages of the present disclosure will become apparent from the following description taken in conjunction with the accompanying drawing sheets, in which like numerals refer to like parts, elements, components, steps, and processes. [Brief explanation of the drawings]

[0016] [Figure 1] FIG. 1 is a perspective view of an ostomy appliance with a filter assembly and a multi-stage filter protector, according to one embodiment. [Figure 2] 1 is a schematic cross-sectional view of a foam pre-filter positioned adjacent to a filter assembly according to one embodiment. [Figure 3] 1 is a diagram of a micro-perforated protective panel, according to one embodiment. [Figure 4] FIG. 1 is a diagram of an embossed protective panel including a diamond pattern, according to one embodiment. [Figure 5] FIG. 1 is a perspective view of an ostomy pouch with a filter assembly and a multi-stage filter protector, according to one embodiment. [Figure 6] 10 is a schematic diagram of a filter assembly and multi-stage filter protector according to another embodiment. [Figure 7] 10 is a schematic diagram of a filter assembly with multi-stage filter protection according to yet another embodiment. [Figure 8] FIG. 1 is a partially exploded view of an ostomy pouch with a filter assembly and a multi-stage filter protector, according to one embodiment. [Figure 9] 1 is a microscope image of a reticulated foam, according to one embodiment. [Figure 10] 1 is a microscope image of reticulated foam loaded with activated carbon, according to one embodiment. [Figure 11] FIG. 1 illustrates an ostomy pouch attached to a test fixture for air flow testing, according to one embodiment. [Figure 12] FIG. 1 is a diagram of a liquid retention test setup, according to one embodiment. [Figure 13]FIG. 13 is a diagram of an ostomy filter clamped to a test fixture in the liquid retention test setup of FIG. 12. [Figure 14] FIG. 1 is a schematic perspective view of an ostomy pouch including a protective panel formed from a perforated film, according to one embodiment. [Figure 15A] FIG. 1 is a schematic diagram of drilling according to one embodiment. [Figure 15B] FIG. 1 is a schematic diagram of drilling according to one embodiment. [Figure 15C] FIG. 1 is a schematic diagram of drilling according to one embodiment. [Figure 15D] FIG. 1 is a schematic diagram of drilling according to one embodiment. [Figure 16] 1 is a graph of volatility analysis test results using an H2S challenge gas. [Figure 17] 1 is a graph of volatility analysis test results using methyl mercaptan challenge gas. [Figure 18] FIG. 10 is a partially exploded view of an ostomy pouch with a filter assembly and a multi-stage filter protector according to another embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0017] One or more embodiments are shown in the drawings and will be described below, with the understanding that while the present disclosure may be embodied in various forms, the disclosure is to be considered merely as illustrative and is not intended to be limited to any specific embodiment described or shown.

[0018] FIG. 1 illustrates an ostomy appliance 10 according to one embodiment. The ostomy appliance 10 may be an ostomy pouch. The ostomy appliance 10 may include outer walls 12 including a body-side wall and a distal-side wall joined together at an outer periphery 14. The outer walls 12 may define an interior volume that may include a collection area according to one embodiment. The ostomy appliance 10 may also include a filter assembly 16 attached to one of the outer walls 12 over a gas outlet provided in the outer wall 12. The filter assembly 16 may be fluidly connected to the collection area such that gases can flow through the filter assembly 16 and exit through the gas outlet. The filter assembly 16 may include a filter media 18 with charcoal, carbon, or other suitable deodorizing material to deodorize gases passing therethrough.

[0019] The ostomy appliance 10 can include a multi-tiered protection section that reduces the risk of ostomy waste clogging the filter assembly 16 and causing ballooning of the ostomy pouch. In one embodiment, the ostomy appliance 10 can include a two-tiered protection section including a protective panel 20 and a pre-filter 24. The first tiered protection section can be the protective panel 20 positioned between two opposing outer walls 12. In the embodiment of FIG. 1, the filter assembly 16 can be attached to the upper portion of the distal side wall. In this embodiment, the protective panel 20 can be positioned in the upper portion of the ostomy appliance 10 and sealed to the opposing outer wall 12 along a peripheral seal 14. The protective panel 20 can also be sealed to the distal side wall along a lower peripheral edge that provides a horizontal seal 22.

[0020] The protective panel 20 can be formed from a perforated film configured to block ostomy output while allowing gas to flow therethrough. In one embodiment, the protective panel 20 can include a plurality of microperforations having micro-sized perforations, as shown in FIG. 3 . In some embodiments, the protective panel 20 can include perforations of various sizes and / or various patterns. For example, the protective panel 20 can include microperforations in a lower portion and no perforations in an upper portion adjacent the filter assembly 16.

[0021] In another embodiment, the protective panel 20 may be formed from a textured film and positioned to protect the filter assembly 16. For example, the protective panel 20 may be formed from an embossed film configured to block ostomy waste while allowing gas to flow therethrough. The embossed film may also be configured to minimize flattening of the ostomy bag, with the protective panel 20 positioned to prevent the outer walls 12 from sticking together and encourage ostomy waste to fall to the bottom of the ostomy pouch. The protective panel 20 may be embossed in various patterns, to various depths, and / or in various locations. In one embodiment, the protective panel 20 may be embossed with a diamond pattern, as shown in FIG. 4. The diamond pattern may be configured to define diagonal channels that provide a gas pathway to the filter assembly 16. The diagonal channels may be configured to reduce the risk of the gas pathway being blocked by ostomy waste. Such diagonal channels are less likely to become blocked than straight vertical and horizontal channels, such as channels defined in a checkerboard pattern. In one embodiment, the protective panel 20 may be formed from a textured film, where at least a portion of the textured film adjacent the prefilter 24 is free of texture. The protective panel 20 may include gas inlet openings or may be discontinuously attached to the exterior wall 12 to provide a gas flow path.

[0022] 5 is a partial perspective view of an ostomy pouch 100 according to one embodiment. The ostomy pouch 100 may be generally similar to the ostomy pouch 10, including a filter assembly 116 and a two-tiered protective section including a protective panel 120 and a pre-filter 124. In this embodiment, the protective panel 120 may be formed from an embossed film including a diamond pattern, which may be sealed to the pouch wall 112 via discontinuous heat seals 122 to provide a gas flow path.

[0023] In one embodiment, the protective panel 20 can be formed from an embossed, perforated film. For example, the protective panel 20 can be formed from an embossed film containing a plurality of micro-perforations. In such an embodiment, the protective panel 20 can be free of texture and perforations adjacent to the prefilter 24.

[0024] In some embodiments, the protective panel 20 may include at least one slit or cut in a lower portion that allows any ostomy waste that accumulates between the protective panel 20 and the outer wall 12 to flow down to a collection area. In one embodiment, the protective panel 20 may include a first set of microperforations located proximate the lower periphery of the protective panel 20 and a second set of microperforations located above the first set of microperforations, the first set of microperforations having a diameter larger than the diameter of the second set of microperforations. In such an embodiment, the first set of microperforations may be configured to allow ostomy waste that accumulates between the protective panel 20 and the outer wall 12 to flow down to the collection area.

[0025] The prefilter 24 can provide a second level of filter protection. Figure 2 is a schematic cross-sectional view of the prefilter 24 adjacent to the filter assembly 16 (the thickness of the prefilter 24 is exaggerated). The prefilter can be formed from any suitable material configured to restrict ostomy waste, including thinner (less viscous) waste, while allowing gas to flow therethrough. Suitable prefilter materials include, but are not limited to, foams such as reticulated open-cell foams, textiles, microfleece, nonwovens, and the like. Some suitable prefilter materials, such as polyurethane foam, textiles, and microfleece, can be hydrophobic materials capable of repelling liquid ostomy waste away from the prefilter 24.

[0026] In one embodiment, the prefilter 24 may be formed from a reticulated polyurethane foam. The foam may have a pore size of about 10 pores per inch (ppi) to about 250 ppi, preferably about 30 ppi to about 200 ppi. For example, the foam may have a pore size of about 40 ppi to about 60 ppi. In the embodiment of FIGS. 1 and 2, the prefilter 24 may be sized and positioned to approximately cover the filter assembly 16. In another embodiment, the prefilter 24 may be sized substantially larger than the filter assembly 16. In yet another embodiment, the prefilter 24 may be positioned to substantially fill the compartment defined between the protective panel 20 and the distal sidewall. The prefilter 24 may be relatively thin to minimize bulkiness of the ostomy appliance 10. In one embodiment, the prefilter 24 may be formed from an open-cell foam having a thickness of about 1 / 32 inch to about 1 / 2 inch, preferably about 1 / 16 inch to about 1 / 4 inch, and more preferably about 1 / 8 inch. The pre-filter 24 may be configured to allow a user to squeeze out liquid absorbed in the pre-filter 24 by applying pressure through the outer wall of the pouch.

[0027] In some embodiments, the ostomy appliance 10 may include more than two levels of filter protection. For example, the ostomy appliance 10 may include at least one heat seal that may be constructed and arranged to protect the filter assembly 16. In one embodiment, the ostomy appliance 10 may include at least one heat seal that seals the protective panel 20 to one of the outer walls 12 adjacent to or surrounding a lower portion of the filter assembly 16 to inhibit ostomy waste from reaching the filter assembly 16 and / or the pre-filter 24.

[0028] 6 is a schematic diagram of a filter assembly 216 and a multi-stage filter guard 217 according to one embodiment. In this embodiment, the filter assembly 216 can include a backing layer 202 and an activated carbon foam filter media 218. The multi-stage filter guard 217 can include a membrane layer 204, a pre-filter 224 formed from a foam material, and a guard panel 220 formed from a micro-perforated film. The membrane layer 204, which can be formed from a suitable gas-permeable material, can be disposed between the filter media 218 and the pre-filter 224. Suitable gas-permeable materials for the membrane layer 204 can include, but are not limited to, membrane materials, gas-permeable polymer films, nonwoven fabrics, etc.

[0029] 7 is a schematic diagram of a filter assembly 316 and a multi-stage filter guard 317 according to another embodiment. In this embodiment, the filter assembly 316 can include a membrane layer 304 and an activated carbon polyester (PET) filter media 318 enclosed in a packet film 302 formed from a gas-impermeable material, the packet film 302 having a gas inlet opening 306 and a gas outlet opening 308. The multi-stage filter guard 317 can include a foam pre-filter 324 and a micro-perforated film guard panel 320.

[0030] 8 is a partially exploded view of an ostomy pouch 400 according to one embodiment. The ostomy pouch 400 may be generally configured similarly to the ostomy pouch 10, including a filter assembly 416 and a multi-stage guard 417 including a protective panel 420 and a pre-filter 424. In this embodiment, the filter assembly 416 may be attached to the exterior of the pouch wall 412, while the multi-stage guard 417 may be located on the interior of the pouch. In another embodiment, the filter assembly 416 and the multi-stage guard 417 may be located on the interior of the pouch, as shown in FIG.

[0031] The filter assembly 416 may include a backing layer 402, a filter media 418, and a membrane layer 404. The filter assembly 416 may be positioned over a gas exit opening 406 defined in the pouch wall 412 and attached to the pouch wall 412 via, for example, heat sealing. The membrane layer 404 may be formed from a suitable gas-permeable material configured to allow gas to flow therethrough while providing protection against ostomy waste. The filter media 418 may be formed from a suitable filter material configured to deodorize ostomy gas. The backing layer 402 may be formed from a suitable material that has relatively low gas permeability or is gas-impermeable and configured to direct gas to flow radially through the filter assembly 416. In this embodiment, gas collected in ostomy pouch 400 can exit through outlet opening 406, flow through membrane layer 404 into filter assembly 416, flow radially through filter media 418, and then exit filter assembly 416, as shown by the arrows in Figure 8. Filter assembly 416 can include at least one gas outlet proximate a periphery of filter assembly 416. For example, filter assembly 416 can include a gas outlet defined by an unsealed periphery.

[0032] The radial gas flow length through the filter media 418 can be affected by the size of the exit opening 406 and the size of the filter media (the larger the exit opening 406, the shorter the gas path through the filter media 418). Additionally, the rate at which gas flows through the filter assembly 116 and exits the ostomy pouch 100 can be adjusted by configuring the size of the exit opening 406 and the gas flow characteristics of the membrane layer 104, such as the porosity of the membrane layer 104. In one embodiment, the size of the exit opening 406 and the membrane layer 404 can be configured to allow enough gas to exit to minimize ballooning of the pouch, while still providing a gas flow length through the filter media 418 for excellent odor removal.

[0033] In one embodiment, the exit opening 406 can have an area of ​​about 0.02 square inches to about 0.15 square inches, preferably about 0.05 square inches to about 0.08 square inches, and more preferably 0.06 square inches to 0.07 square inches. The exit opening 406 can be provided in a variety of shapes, such as, for example, a circular opening, an oval opening, a rectangular opening, a square opening, etc. In one embodiment, the exit opening 406 can be defined by a square-shaped opening having an area of ​​about 0.0625 square inches (0.25 inches by 0.25 inches).

[0034] Suitable materials for backing layer 402 include, but are not limited to, polymeric films having substantially lower gas permeability than filter media 418. For example, backing layer 402 can be formed from a polymeric film such as a low-density polyethylene (LDPE) film. Backing layer 402 can have a thickness of about 2 mils to about 10 mils, preferably about 3 mils to about 7 mils, and more preferably about 5 mils.

[0035] The filter media 418 can be formed from any suitable filter material, including charcoal, carbon, or other suitable deodorizing materials that deodorize gases. Suitable filter materials for the filter media 418 include, but are not limited to, activated carbon foam materials, such as filter materials including reticulated foam and activated carbon, activated carbon nonwoven fabrics, and activated carbon fabrics. Figure 9 is a microscopic image of a reticulated foam according to one embodiment, and Figure 10 is a microscopic image of a reticulated foam filled with activated carbon according to one embodiment. The filter media 418 can have a thickness of about 0.03 inches to about 0.15 inches, preferably about 0.06 inches to about 0.12 inches, and more preferably about 0.07 inches to about 0.1 inches.

[0036] In one embodiment, the filter media 418 may be formed from a reticulated polyurethane (PU) foam, such as the PU foam filter material available from Freudenberg, containing activated carbon and having a thickness of approximately 0.089 inches. Such PU foam filter material may be hydrophobic, which may provide additional benefits to the filter assembly 416 disposed on the exterior surface of the pouch. For example, the hydrophobic filter media 418 may resist water, eliminating the need for a filter sticker when the filter assembly 416 is exposed to water, such as during showering or swimming.

[0037] The membrane layer 404 can be formed from any suitable gas-permeable material. Suitable gas-permeable materials for the membrane layer 404 include, but are not limited to, ePTFE (expanded polytetrafluoroethylene) membrane, UHMW PE (ultra-high molecular weight polyethylene) membrane, pulp / polyester membrane, spunmelt PP (polypropylene) membrane, SMS PP (spunbond meltblown spunbond polypropylene) nonwoven, and the like. The membrane layer 404 can have a thickness of about 0.5 mil to about 15 mil, preferably about 0.8 mil to about 12 mil. In one embodiment, the membrane layer 404 can be formed from a three-layer SMS PP nonwoven including a spunbond PP top layer, a meltblown PP middle layer, and a spunbond PP bottom layer, having a basis weight of about 10 gsm to about 500 gsm, preferably about 30 gsm to about 120 gsm, and more preferably about 40 gsm to about 80 gsm. For example, the membrane layer 404 may be formed from an SMS PP nonwoven fabric having a basis weight of about 44 gsm, available from Precision Fabrics Group Inc. under Style T063-73960. In another embodiment, the membrane layer 104 may be formed from a microporous UHMW PE membrane having a basis weight of about 1 gsm to about 20 gsm, preferably about 2 gsm to about 5 gsm, a thickness of about 10 μm to about 50 μm, preferably about 15 μm to about 40 μm, and a porosity of about 60% to about 90%, preferably about 70% to about 85%. For example, the membrane layer 104 may be formed from a microporous UHMW PE membrane having a basis weight of about 3 gsm, a thickness of about 20 μm, and a porosity of about 83%, available from Lydall Performance Materials BV under the trade name Solupor® membranes 3P07A.

[0038] In one embodiment, the filter assembly 416 can be configured to minimize ballooning while still providing excellent odor filtration and preventing leakage of ostomy waste. These characteristics of the filter assembly can be evaluated by analyzing airflow through the filter assembly, liquid hold-out, which measures the pressure at which liquid is forced through the membrane layers of the filter assembly, and odor removal data.

[0039] 8, the air flow rate and liquid retention of filter assembly 416 may be primarily determined by the properties of membrane layer 404. For many prior art filter assemblies, such as those including a membrane layer formed from ePTFE membrane or UHMW PE membrane, the cost of the membrane layer is often the largest portion of the total material cost of the filter assembly. For example, the cost of a membrane layer formed from ePTFE membrane may constitute more than 50% of the total material cost of the filter assembly.

[0040] The inventors of the present application have researched and analyzed numerous different membrane materials, nonwoven materials, fabric materials, and other gas-permeable materials to identify suitable materials for the filter membrane layer that can provide comparable or better filter properties at a substantial cost reduction. After substantial time and investment in research and development, it has been discovered that a filter assembly including a membrane layer formed from an SMS PP nonwoven material commonly used in hospital gowns can provide surprisingly superior filter membrane properties, such as air flow and liquid retention, at a substantially lower cost. For example, the cost of an SMS PP nonwoven material can be as low as about 1% of the cost of an ePTFE membrane material. Table 1 shows air flow and liquid retention data for various membrane materials.

[0041] [Table 1]

[0042] Air flow was tested using an Isaac HD Multi-Function Leak Tester (Isaac Tester) equipped with a mass flow meter (MFM), which measures the mass flow rate of air through the pouch to maintain a specified pressure. A square, Teflon-coated test plate with alignment holes near each corner and a central opening for air to enter the pouch was used to mount the pouch. A test fixture containing two air cylinders was used to clamp the test plate and the attached pouch. The test fixture had a defined hole that allowed air to flow from the pressure transducer into the pouch.

[0043] The airflow data in Table 1 were collected by measuring the airflow rate to maintain 0.18 psi pressure within a sample pouch fitted with a filter assembly or membrane (as shown in Table 1) to cover the gas exit opening. The barrier backing was removed, and the sample pouch was attached to the test plate by centering the pouch's starter hole over the center hole of the test plate to prevent an airflow path between the barrier and the test plate. The test plate with the attached pouch was then mounted in a test fixture using locating pins to guide alignment and clamped down with air pressure, as shown in Figure 11. The airflow rate to maintain a pressure of 0.18 ± 0.018 psi was measured and recorded using an Isaac tester.

[0044] A test equipment system (FIG. 12) including a liquid pressure tank, air source, and liquid pressure gauge was used to test liquid retention by measuring the pressure at which a liquid (water was used for the data provided in Table 1) was forced through the membrane layer of a membrane or filter assembly. A sample membrane or sample filter assembly (as shown in Table 1) was placed on the fixture, and a filter clamp was positioned on the fixture so that it was aligned over the membrane or filter assembly as shown in FIG. 13. After closing the filter clamp via the air pressure valve, the system pressure was increased until water penetrated the membrane layer of the sample membrane or sample filter assembly.

[0045] After detailed consideration and careful study of the phenomenon of ostomy pouch ballooning, leakage of waste through ostomy filters, and filtration of ostomy gases, as well as analysis of air flow rate and liquid retention data for numerous membrane materials and filter assemblies, it was discovered that an ostomy pouch with a filter assembly configured to have an air flow rate at 0.18 psi greater than about 10 cc / s and less than about 40 cc / s, and a liquid (water) retention rate greater than about 0.9 psi, can minimize pouch ballooning while still preventing leakage of ostomy waste.

[0046] In one embodiment, the filter assembly 416 includes a backing layer 402 formed from an LDPE film having a thickness of about 5 mils and a resistance of about 26 kg / m (tested according to ISO 845). 3 ~about 30kg / m 3 The filter assembly 416 may include a filter media 418 formed from activated carbon reticulated PU foam having a net density of about 1.0 g / s and a membrane layer 404 formed from SMS PP nonwoven fabric having a basis weight of about 44 gsm. The filter assembly 416 may be configured to cover an outlet opening 406 having an area of ​​about 0.06 to about 0.07 square inches, have an air flow rate at 0.18 psi greater than about 10 cc / s and less than about 40 cc / s, and a liquid (water) retention force greater than about 0.9 psi and less than about 3.0 psi. In one embodiment, the filter assembly 416 may be configured to cover an outlet opening 406 having an area of ​​about 0.0625 square inches, have an air flow rate at 0.18 psi greater than about 15 cc / s and less than about 35 cc / s, and a liquid (water) retention force greater than about 1.0 psi and less than about 2.0 psi. The filter assembly 416 may be provided in a variety of shapes, such as circular, oval, rectangular, or square.

[0047] A backing layer 402 formed from an LDPE film having a square body with side lengths of 1.165 inches and a thickness of about 5 mils and a strength of about 26 kg / m (tested according to ISO 845). 3 ~about 30kg / m 3A sample filter assembly 416 including a filter media 418 formed from activated carbon reticulated PU foam having a net density of 100 psi and a membrane layer 404 formed from an SMS PP nonwoven fabric having a basis weight of approximately 44 gsm was prepared and tested for odor removal performance along with a prior art filter assembly. Volatility analysis was performed using a challenge gas containing 5 ppm H2S in dry nitrogen and a challenge gas containing 5 ppm methyl mercaptan (MM) in dry nitrogen. Test parameters included a challenge gas humidified to 25% RH (relative humidity), a challenge gas flow rate to the filter of 15 cc / s, and a back pressure of 0.8 psi. Figure 16 is a graph of the volatility analysis test results using the H2S challenge gas, and Figure 17 is a graph of the volatility analysis test results using the MM challenge gas. As shown in Figures 16 and 17, the filter assembly 416 samples (referred to as "Sample 1" and "Sample 2") exhibited superior odor removal properties compared to the Coloplast SenSura® Mio filter assembly sample including an e-PTFE membrane and the Salt Healthcare Confidence BE® filter assembly sample including an e-PTFE membrane, and similar odor removal properties compared to the Dansac NovaLife filter assembly sample including a UHMW PE membrane.

[0048] 8, the multi-stage filter protection 417 may include a pre-filter 424 positioned over the gas exit opening 406 and sealed to the inner surface of the pouch wall 412, and a protective panel 420 covering the pre-filter 424 and sealed to the inner surface of the pouch wall 412. In such an embodiment, the protective panel 420 may function as a coarse pre-filter and a first line of protection, and the pre-filter 424 may function as a fine pre-filter and a second line of protection, so as to provide multiple protection for the filter assembly 416 from ostomy waste collected in the pouch.

[0049] In one embodiment, the prefilter 424 can include a first layer 425 and an optional second layer 423. The first layer 425 can be formed from any suitable material configured to block particulates and containing sufficient gas flow passages / channels to provide substantially lower gas flow resistance compared to the optional second layer 423 or the membrane layer 404. Suitable materials for the first layer 425 include, but are not limited to, open-cell foams and reticulated foams containing from about 10 ppi to about 250 ppi, preferably from about 30 ppi to about 200 ppi. For example, the first layer 425 can be formed from reticulated foam containing about 200 ppi. Suitable materials for the first layer 425 are not limited to foam materials and can include other similar materials configured for fine particulate blocking and relatively low gas flow resistance. The first layer 425 can have a thickness of from about 1 / 32 inch to about 1 / 2 inch, preferably from about 1 / 16 inch to about 1 / 4 inch, and more preferably about 1 / 8 inch. In one embodiment, the first layer 425 may be formed from a reticulated PU foam having about 45 ppi and a thickness of about 1 / 8 inch. In some embodiments, the first layer 425 may be laminated to the second layer 423.

[0050] The second layer 423 can be formed from a suitable material configured to provide some support to the first layer 425 during handling and processing, as well as heat-sealability to the pouch wall 412. Suitable materials for the second layer 423 include, but are not limited to, nonwoven materials, membrane materials, gas-permeable polymeric materials, and the like. For example, the second layer 423 can be formed from a polyester (PET) nonwoven or SMS PP nonwoven having a basis weight of about 10 gsm to about 500 gsm, preferably about 20 gsm to about 100 gsm, and more preferably about 30 gsm to about 50 gsm. The prefilter 424 can be configured to allow a user to apply pressure through the pouch wall to squeeze out any liquid absorbed by the first layer 425. The second layer 423 is optional. In embodiments in which the prefilter 424 does not include the second layer 423, the first layer 425 may be sealed directly to the pouch wall 412.

[0051] The protective panel 420 can be formed from a suitable micro-perforated film and sealed to the pouch wall 412 via a perimeter seal. In one embodiment, the protective panel 420 can be configured and sized slightly larger than the pre-filter 423 so as to cover and seal the perimeter of the pre-filter 423. In other embodiments, the protective panel can be configured to cover about ⅕ to about ⅔ of the upper portion of the ostomy pouch, preferably about ¼ to about ½ of the upper portion of the ostomy pouch. The micro-perforated film can be formed from a suitable polymeric material configured to heat seal to the pouch wall 412. In one embodiment, the protective panel 420 can be formed from a copolymer including about 8% ethylene-vinyl acetate (EVA). The protective panel 420 can have a thickness of about 0.5 mils to about 10 mils, preferably about 1 mil to about 5 mils.

[0052] The protective panel 420 can include microperforations in a portion, multiple portions, or throughout the entire area of ​​the protective panel 420. In the embodiment of Figure 8, the protective panel 420 can include microperforations 430 only in the lower portion of the protective panel 420. In such an embodiment, gas collected in the ostomy pouch 400 can flow through the microperforations 430 in the lower portion of the protective panel 420, flow upward through the prefilter 424, exit the pouch through the gas exit opening 406, flow through the membrane layer 404, and exit the filter assembly 416 after being filtered through the filter media 418, as shown by the arrows in Figure 8.

[0053] The protective panel 420 can include microperforations defined by a plurality of generally circular cylindrical openings having diameters of about 50 μm to about 500 μm, preferably about 100 μm to about 450 μm, and more preferably about 150 μm to about 400 μm. In one embodiment, the protective panel 420 can include microperforations in a lower portion of the protective panel 420, the microperforations having a pore density of about 10 ppi to about 500 ppi, preferably about 100 ppi to about 300 ppi. In some embodiments, the protective panel 420 can include microperforations of various sizes, various patterns, various shapes, and / or in selected portions of the protective panel 420.

[0054] 14 shows an ostomy pouch with a protective panel 520 according to one embodiment, the protective panel 520 including a first set of microperforations 530 in a lower portion of the protective panel 520 and a second set of microperforations 532 disposed above the first set of microperforations 530. The first set of microperforations 530 can be defined by a plurality of openings having a diameter larger than the diameter of the second set of microperforations 532. For example, the first set of microperforations 530 can be defined by a plurality of generally circular cylindrical openings having a diameter of about 250 μm to about 500 μm, preferably about 300 μm to about 400 μm, and more preferably about 350 μm to about 380 μm. The second set of microperforations 532 may be defined by generally circular cylindrical openings having diameters of about 50 μm to about 300 μm, preferably about 100 μm to about 250 μm, and more preferably about 125 μm to about 175 μm.

[0055] In one embodiment, the protective panel 520 can be formed from a copolymer film containing approximately 8% EVA and having a thickness of approximately 2.1 mils, and can include microperforations, including a first set of microperforations 530 defined by a plurality of openings having a diameter of approximately 380 μm arranged in two rows and a second set of microperforations 532 defined by a plurality of openings having a diameter of approximately 150 μm arranged in 24 rows, with the microperforations having a pore density of approximately 100 ppi. The protective panel 520 can be configured to block coarse particles and to be heat-sealed to the pouch wall along its periphery. In some embodiments, the protective panel 520 can be provided with slits or openings adjacent its lower periphery to allow any liquid accumulated between the protective panel and the pouch wall to drain.

[0056] The protective panel can include micro-perforations formed by openings having various 3D shapes through the thickness of the protective panel, such as the 3D shapes shown in Figures 15A-15D.

[0057] It is understood that the relative directions described above, e.g., "upper," "lower," "upper," "lower," "above," and "below," are used for illustrative purposes only and may vary depending on the orientation of the ostomy pouch and / or the patient. Thus, this terminology is non-limiting in nature. Additionally, it is understood that various features of one or more of the above-described embodiments may be used with, combined with, or substituted for other features of different embodiments described herein.

[0058] All patents referenced herein are incorporated by reference in their entirety, whether or not specifically indicated in the body of this disclosure.

[0059] In this disclosure, the words "a" and "an" are to be construed to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular.

[0060] From the foregoing, it will be appreciated that numerous modifications and variations may be effected without departing from the true spirit and scope of the novel concepts of the present invention. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should be inferred. The present disclosure is intended by the appended claims to cover all modifications that fall within the scope of the claims.

Claims

1. a proximal wall and a distal wall joined at an outer periphery and defining an interior volume including a collection region; an inlet for receiving ostomy output; an outlet through which gas collected in the collection region exits; a filter assembly covering the outlet; a multi-stage filter protector configured to protect the filter assembly; Equipped with the multi-stage filter protection unit includes a pre-filter and a protection panel that covers the pre-filter, the protective panel is formed from a microperforated film including a first set of microperforations including a plurality of openings having a diameter of about 300 μm to about 500 μm and a second set of microperforations including a plurality of openings having a diameter of about 50 μm to about 200 μm; the first set of microperforations is disposed proximate a lower periphery of the protective panel; The ostomy pouch wherein the second set of microperforations is positioned above the first set of microperforations closer to the prefilter.

2. a proximal wall and a distal wall joined at an outer periphery and defining an interior volume including a collection region; an inlet for receiving ostomy output; an outlet through which gas collected in the collection region exits; a filter assembly covering the outlet, the filter assembly including a membrane layer, a backing layer, and a filter media disposed between the membrane layer and the backing layer, the filter assembly being attached to an exterior or interior surface of one of the body-side wall and the distal-side wall such that the membrane layer covers the outlet, the membrane layer being formed from an SMS PP nonwoven fabric; An ostomy pouch comprising: a multi-stage filter protector configured to protect the filter assembly, the multi-stage filter protector including a pre-filter and a protective panel covering the pre-filter.

3. the filter assembly is attached to an exterior surface of one of the body wall and the distal wall; 3. The ostomy pouch of claim 1, wherein the multi-stage filter protector is disposed inside the ostomy pouch.

4. the filter assembly is attached to an outer surface of the distal sidewall; 3. The ostomy pouch of claim 1, wherein the pre-filter and the protective panel are attached to the inner surface of the distal sidewall.

5. 3. The ostomy pouch of claim 1, wherein the filter assembly, the pre-filter, and the protective panel are attached to an inner surface of the distal sidewall.

6. 3. The ostomy pouch of claim 2, wherein the protective panel is formed from a microperforated film, an embossed film, or a microperforated embossed film.

7. the protective panel is formed from a microperforated film containing a plurality of openings having diameters of about 100 μm to 500 μm; the plurality of openings are arranged to provide a pore density of from about 25 ppi to about 300 ppi; 7. The ostomy pouch of claim 6, wherein the protective panel is sealed to the distal sidewall and / or the body sidewall along an outer peripheral seal.

8. the protective panel is formed from a microperforated film comprising a first set of microperforations comprising a plurality of openings having a diameter of about 300 μm to about 500 μm and a second set of microperforations comprising a plurality of openings having a diameter of about 50 μm to about 200 μm; the first set of microperforations is disposed proximate a lower periphery of the protective panel; 8. The ostomy pouch of claim 6 or 7, wherein the second set of microperforations is located above the first set of microperforations closer to the prefilter.

9. the protective panel is sealed to the distal sidewall along a lower periphery to provide a horizontal seal; 10. The ostomy pouch of claim 1 or 7, wherein at least a portion of the protective panel adjacent the filter assembly is free of openings.

10. the horizontal seal is a discontinuous heat seal; or 10. The ostomy pouch of claim 9, wherein the protective panel includes at least one slit or opening adjacent the lower periphery configured to allow liquid that accumulates between the protective panel and the distal sidewall to drain into the collection area.

11. The ostomy pouch of any one of claims 1 to 10, wherein the prefilter comprises a first layer formed from reticulated foam or open-cell foam.

12. 12. The ostomy pouch of claim 11, wherein the first layer is formed from reticulated polyurethane (PU) foam.

13. the prefilter further comprises a second layer; the first layer is laminated to the second layer; 13. The ostomy pouch of claim 11 or 12, wherein the prefilter is attached to the distal wall by heat sealing the second layer to the inner surface of the distal wall.

14. 14. The ostomy pouch of claim 13, wherein the second layer is formed from a polyester nonwoven fabric or a spunbond-meltblown-spunbond polypropylene (SMS PP) nonwoven fabric.

15. the filter assembly includes a membrane layer, a backing layer, and a filter medium disposed between the membrane layer and the backing layer; 10. The ostomy pouch of claim 1, wherein the filter assembly is attached to an exterior or interior surface of one of the body side wall and the distal side wall such that the membrane layer covers the outlet.

16. 16. The ostomy pouch of claim 2 or 15, wherein the backing layer is formed from a low density polyethylene film.

17. the filter medium is formed from activated carbon impregnated foam; 16. The ostomy pouch of claim 2 or 15, wherein the activated carbon impregnated foam is hydrophobic.

18. 18. The ostomy pouch of claim 17, wherein the filter media is formed from activated carbon reticulated PU foam.

19. 16. The ostomy pouch of claim 15, wherein the membrane layer is formed from an SMS PP nonwoven fabric.

20. 20. The ostomy pouch of claim 2 or 19, wherein the SMS PP nonwoven has a basis weight of about 40 gsm to about 80 gsm.

21. the filter assembly is configured to provide a radial gas flow path through the filter media; 16. The ostomy pouch of claim 2 or 15, wherein the filter assembly is configured to direct the gas exiting through the outlet to flow through the membrane layer, flow radially through the filter media, and exit the filter assembly through at least one gas outlet located adjacent an outer periphery of the filter assembly.

22. 16. The ostomy pouch of claim 2 or 15, wherein the filter assembly and the multi-stage filter guard are constructed and arranged to allow gas collected in the collection area to flow through microperforations in the guard panel, through the pre-filter, exit the ostomy pouch through the outlet, through the membrane layer, and radially through the filter media before exiting the filter assembly.

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