Ostomy Filter

Abstract

The ostomy pouch includes a body sidewall and a distal sidewall joined at an outer periphery and defining an interior volume including a collection area. The ostomy pouch also includes an inlet for receiving ostomy waste, an outlet for gases collected in the collection area to exit, and a filter assembly covering the outlet. The ostomy pouch is configured to have an air flow rate at 0.18 psi greater than about 10 cc / s and less than about 40 cc / ss, and a liquid (water) retention capacity greater than about 0.9 psi and less than about 6.0 psi.

Description

[Technical Field]

[0001] The following description relates to ostomy appliances, and more particularly to odor-removing filters for ostomy appliances. [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 the escape of gases from the pouch as well as filtering odors. However, in some cases, liquid, semi-solid, or solid contents (i.e., waste) can flow into and close the filter assembly, thereby restricting the escape of gases through the filter assembly. This can lead to ballooning of the pouch, caused by increased gas pressure and undesired expansion of the pouch. Summary of the Invention [Problem to be solved by the invention]

[0003] The quality of life impacts from pouch ballooning can be significant for ostomates, including anxiety, lack of caution, fear of leakage, nighttime attention, and inconvenient user intervention to release 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 a lot of time dealing with pouch ballooning issues and feeling resigned to their current ostomy pouch systems.

[0004] Furthermore, the cost of the filter assembly is relatively high and represents a significant portion of the total cost of the ostomy appliance.

[0005] Therefore, it is desirable to provide a cost-effective filter assembly for an ostomy appliance that can minimize ballooning. [Means for solving the problem]

[0006] In one embodiment, the ostomy pouch can be 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) holding capacity greater than about 0.9 psi and less than about 6.0 psi. The ostomy pouch can include a bodyside wall and a distal sidewall 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, an outlet for gas collected in the collection area to exit, and a filter assembly positioned to cover the outlet. The filter assembly can include a backing layer, a filter medium, and a membrane layer, the backing layer having a lower gas permeability than the filter medium.

[0007] In one embodiment, the membrane layer may be formed from a spunbond-meltblown-spunbond polypropylene (SMS PP) nonwoven fabric. The filter media may be formed from an activated carbon-impregnated foam, which may be hydrophobic. For example, the filter media may be formed from an activated carbon-impregnated reticulated polyurethane (PU) foam. The pouch gas outlet may be defined by an opening having an area of ​​about 0.06 to about 0.07 square inches.

[0008] In one embodiment, the backing layer may be formed from a low density polyethylene film and the filter media has a weight of about 26 kg / m (tested according to ISO 845). 3 ~about 30kg / m 3 The membrane layer may be formed from activated carbon reticulated PU foam having a net density of about 1.5 gsm, and the membrane layer may be formed from SMS PP nonwoven fabric having a basis weight of about 44 gsm. The pouch gas outlet may be defined by an opening having an area of ​​about 0.06 to about 0.07 square inches. The ostomy pouch may be 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 capacity greater than about 0.9 psi and less than about 3.0 psi.

[0009] In another embodiment, the backing layer may be formed from a low density polyethylene film and the filter media has a density of about 26 kg / m (tested according to ISO 845). 3 ~about 30kg / m 3 The membrane layer may be formed from activated carbon reticulated PU foam having a net density of about 1.5 gsm, and the membrane layer may be formed from SMS PP nonwoven fabric having a basis weight of about 44 gsm. The pouch gas outlet may be defined by an opening having an area of ​​about 0.0625 square inches. The ostomy pouch may be configured to 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 capacity greater than about 1.0 psi and less than about 2.0 psi.

[0010] In one embodiment, the filter assembly may be attached to an exterior surface of one of the bodyside and distal sidewalls and configured to provide a radial gas flow path through the filter media. In such an embodiment, the filter assembly may be configured to allow gas exiting through an 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 an outer periphery of the filter assembly.

[0011] In some embodiments, the ostomy pouch may further include a pre-filter and a protective panel that may be configured to protect the filter assembly from ostomy waste. The filter assembly may be attached to an outer surface of the distal sidewall, and the pre-filter and protective panel may be attached to an inner surface of the distal sidewall. In such embodiments, the ostomy pouch may be configured to provide a flow path for gas collected in the collection area to flow through microperforations in the protective panel, through the pre-filter, exit the ostomy pouch through an outlet, through the membrane layer, and radially through the filter media before exiting the filter assembly.

[0012] In one embodiment, the filter assembly can be attached to the interior surface of one of the bodyside wall and the distal side wall and 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 allow gas collected in the collection region to flow into the filter assembly through at least one gas outlet located proximate the outer periphery of the filter assembly, flow radially through the filter media, flow through the membrane layer, and then exit the ostomy pouch through the outlet.

[0013] In some embodiments, the ostomy pouch may further include a pre-filter and a protective panel, and the filter assembly, pre-filter, and protective panel may be attached to the inner surface of the distal sidewall. In such embodiments, the ostomy pouch may be configured to provide a flow path for gas collected in the collection area to flow through microperforations in the protective panel, through the pre-filter, enter the filter assembly through at least one gas inlet located proximate the outer periphery of the filter assembly, flow radially through the filter media, flow through the membrane layer, and then exit the ostomy pouch through an outlet.

[0014] 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]

[0015] [Figure 1] FIG. 1 is a partially exploded view of an ostomy pouch with a filter assembly, according to one embodiment. [Figure 2] 1 is a microscope image of a reticulated foam, according to one embodiment. [Figure 3] 1 is a microscope image of reticulated foam loaded with activated carbon, according to one embodiment. [Figure 4] FIG. 1 illustrates an ostomy pouch attached to a test fixture for air flow testing, according to one embodiment. [Figure 5] FIG. 1 is a diagram of a liquid retention test setup, according to one embodiment. [Figure 6] FIG. 6 is a diagram of an ostomy filter clamped to a test fixture in the liquid retention test setup of FIG. 5. [Figure 7] 1 is a graph of volatility analysis test results using an H2S challenge gas. [Figure 8] 1 is a graph of volatility analysis test results using methyl mercaptan challenge gas. [Figure 9] 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 10] FIG. 10 is a partially exploded view of an ostomy pouch with a filter assembly according to another embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0016] One or more embodiments are shown in the drawings and 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 that any specific embodiments described or shown are not intended to limit the disclosure.

[0017] 1 is a partially exploded view of an ostomy pouch 100 according to one embodiment. The ostomy pouch 100 may include a filter assembly 116. In some embodiments, the ostomy pouch 100 may also include a multi-tiered guard 117 including a protective panel 120 and a pre-filter 124. In the embodiment of FIG. 1, the filter assembly 116 may be attached to the exterior of the pouch wall 112, while the multi-tiered guard 117 may be disposed on the interior of the pouch.

[0018] The filter assembly 116 may include a backing layer 102, a filter media 118, and a membrane layer 104. The filter assembly 116 may be positioned to cover the gas exit opening 106 defined in the pouch wall 112 and may be attached to the pouch wall 112 via, for example, heat sealing. The membrane layer 104 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 118 may be formed from a suitable filter material configured to deodorize ostomy gas. The backing layer 102 may be formed from a suitable material that has relatively low gas permeability or is gas-impermeable and may be configured to direct gas to flow radially through the filter assembly 116. In this embodiment, gas collected in ostomy pouch 100 may exit through outlet opening 106, flow through membrane layer 104 into filter assembly 116, flow radially through filter media 118, and then exit filter assembly 116, as shown by the arrows in Figure 1. Filter assembly 116 may include at least one gas outlet proximate a periphery of filter assembly 116. For example, filter assembly 116 may include a gas outlet defined by an unsealed periphery.

[0019] The radial gas flow length through the filter media 118 may be determined by the size of the exit opening 106 and the size of the filter media 118 (the larger the exit opening 106, the shorter the gas path through the filter media 118). Additionally, the rate of gas flow exiting the ostomy pouch 100 through the filter assembly 116 may be adjusted by configuring the size of the exit opening 106 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 106 and the membrane layer 104 may 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 118 for excellent odor removal.

[0020] In one embodiment, the exit opening 106 may 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 106 may 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 106 may be defined by a square-shaped opening having an area of ​​about 0.0625 square inches (0.25 inches by 0.25 inches).

[0021] Suitable materials for the backing layer 102 may include, but are not limited to, polymeric films having substantially lower gas permeability than the filter media 118. For example, the backing layer 102 may be formed from a polymeric film such as a low-density polyethylene (LDPE) film. The backing layer 102 may 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.

[0022] The filter media 118 may 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 118 may 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 2 is a microscopic image of a reticulated foam according to one embodiment, and Figure 3 is a microscopic image of a reticulated foam filled with activated carbon according to one embodiment. The filter media 118 may 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.

[0023] In one embodiment, the filter media 118 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, providing additional benefits to the filter assembly 116 disposed on the exterior surface of the pouch. For example, the hydrophobic filter media 118 may repel water, thereby eliminating the need for a filter sticker when the filter assembly 116 is exposed to water, such as during showering or swimming.

[0024] The membrane layer 104 may be formed from a suitable gas-permeable material. Suitable gas-permeable materials for the membrane layer 104 may 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 104 may 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 104 has a thickness of about 10 g / m 2The membrane layer 104 may be formed from a three-layer SMS PP nonwoven fabric including a spunbond PP top layer, a meltblown PP middle layer, and a spunbond PP bottom layer, having a basis weight of from about 500 gsm (gsm), preferably from about 30 gsm to about 120 gsm, and more preferably from about 40 gsm to about 80 gsm. For example, the membrane layer 104 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 from about 1 gsm to about 20 gsm, preferably from about 2 gsm to about 5 gsm, a thickness of from about 10 μm to about 50 μm, preferably from about 15 μm to about 40 μm, and a porosity of from about 60% to about 90%, preferably from 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%, which is available from Lydall Performance Materials BV under the trade name Solupor® membranes 3P07A.

[0025] In one embodiment, filter assembly 116 can be configured to minimize ballooning while still providing excellent odor filtration and preventing leakage of ostomy waste. These characteristics of a filter assembly can be evaluated by analyzing airflow through the filter assembly, liquid retention, which measures the pressure at which liquid is forced through the membrane layers of the filter assembly, and odor removal data.

[0026] 1, the air flow rate and liquid retention capacity of the filter assembly 116 may be determined primarily by the properties of the membrane layer 104. 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 the membrane layer formed from ePTFE membrane may constitute more than 50% of the total material cost of the filter assembly.

[0027] The present inventors 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 considerable 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 significantly 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 or a UHMW PE membrane material. Table 1 shows air flow and liquid retention data for various membrane materials.

[0028] [Table 1]

[0029] 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.

[0030] 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 aligning the starter hole of the pouch over the center hole of the test plate, ensuring no airflow path was formed between the barrier and the test plate. The test plate with the attached pouch was then mounted in the test fixture using locating pins to guide alignment and clamped down with air pressure, as shown in Figure 4. The airflow rate to maintain a pressure of 0.18 ± 0.018 psi was measured and recorded using an Isaac tester.

[0031] A test equipment system (Figure 5) including a liquid pressure tank, air source, and liquid pressure gauge was used to test the liquid retention capacity 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 top of the fixture so that it was aligned over the membrane or filter assembly as shown in Figure 6. 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.

[0032] After detailed consideration and careful study of the phenomenon of ballooning of ostomy pouches, 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 has been 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, preferably greater than about 0.9 psi and less than about 6.0 psi, can minimize pouch ballooning while still preventing leakage of ostomy waste.

[0033] In one embodiment, the filter assembly 116 includes a backing layer 102 formed from an LDPE film having a thickness of about 5 mils and a resistance to moisture of about 26 kg / m (tested according to ISO 845). 3 ~about 30kg / m 3 The filter assembly 116 may include a filter media 118 formed from activated carbon reticulated PU foam having a net density of about 0.06 to about 0.07 square inches, and a membrane layer 104 formed from SMS PP nonwoven fabric having a basis weight of about 44 gsm. The filter assembly 116 may be configured to cover an outlet opening 106 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 116 may be configured to cover an outlet opening 106 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 116 may be provided in a variety of shapes, such as circular, oval, rectangular, or square.

[0034] A backing layer 102 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 resistance of about 26 kg / m (tested according to ISO 845). 3 ~about 30kg / m 3A sample filter assembly 116 including a filter media 118 formed from activated carbon reticulated PU foam having a net density of 100 psi and a membrane layer 104 formed from an SMS PP nonwoven fabric having a basis weight of approximately 44 gsm was prepared and tested for odor removal properties 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 7 is a graph of the volatility analysis test results using the H2S challenge gas, and Figure 8 is a graph of the volatility analysis test results using the MM challenge gas. As shown in Figures 7 and 8, filter assemblies 116 (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 exhibited similar odor removal properties compared to the Dansac NovaLife filter assembly sample including a UHMW PE membrane.

[0035] 1, multi-stage filter protection 117 may include a pre-filter 124 positioned over gas exit opening 106 and sealed to the inner surface of pouch wall 112, and a protective panel 120 covering pre-filter 124 and sealed to the inner surface of pouch wall 112. In such an embodiment, protective panel 120 may function as a coarse pre-filter and a first line of protection, and pre-filter 124 may function as a fine pre-filter and a second line of protection, to provide multiple protection for filter assembly 116 from ostomy waste collected in the pouch.

[0036] In one embodiment, the prefilter 124 may include a first layer 125 and an optional second layer 123. The first layer 125 may be configured to block particulates and may be formed from any suitable material containing sufficient gas flow passages / channels to provide substantially lower gas flow resistance compared to the optional second layer 123 or the membrane layer 104. Suitable materials for the first layer 125 may include, but are not limited to, open-cell foam and reticulated foam containing about 10 pores per inch (ppi) to about 250 ppi, preferably about 30 ppi to about 200 ppi. For example, the first layer 125 may be formed from a reticulated foam containing about 200 ppi. Suitable materials for the first layer 125 are not limited to foam materials and may include other similar materials configured for fine particulate blocking and relatively low gas flow resistance. The first layer 125 may have 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. In one embodiment, first layer 125 may be formed from reticulated PU foam having about 45 ppi and a thickness of about 1 / 8 inch. In some embodiments, first layer 125 may be laminated to second layer 123.

[0037] The second layer 123 may be formed from a suitable material configured to provide some support to the first layer 125 during handling and processing, as well as heat-sealability to the pouch wall 112. Suitable materials for the second layer 123 include, but are not limited to, nonwoven materials, membrane materials, gas-permeable polymeric materials, and the like. For example, the second layer 123 may 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 124 may be configured to allow a user to apply pressure through the pouch wall to squeeze out any liquid absorbed by the first layer 125. The second layer 123 is optional. In embodiments in which the prefilter 124 does not include the second layer 123, the first layer 125 may be sealed directly to the pouch wall 112.

[0038] The protective panel 120 may be formed from a suitable micro-perforated film and sealed to the pouch wall 112 via a perimeter seal. In one embodiment, the protective panel 120 may be configured and sized slightly larger than the pre-filter 123 so as to cover and seal the perimeter of the pre-filter 123. In other embodiments, the protective panel may 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 may be formed from a suitable polymeric material configured to heat seal to the pouch wall 112. In one embodiment, the protective panel 120 may be formed from a copolymer comprising about 8% ethylene-vinyl acetate (EVA). The protective panel 120 may have a thickness of about 0.5 mils to about 10 mils, preferably about 1 mil to about 5 mils.

[0039] The protective panel 120 may include microperforations in a portion, two or more portions, or throughout the entire area of ​​the protective panel 120. In the embodiment of FIG. 1, the protective panel 120 may include microperforations 130 only in a lower portion of the protective panel 120. In such an embodiment, gas collected in the ostomy pouch 100 may flow through the microperforations 130 in the lower portion of the protective panel 120, flow upward through the prefilter 124, exit the pouch through the gas exit opening 106, flow through the membrane layer 104, and be filtered through the filter media 118 before exiting the filter assembly 116, as shown by the arrows in FIG.

[0040] The protective panel 120 may 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 120 may include microperforations in a lower portion of the protective panel 120, the microperforations having a pore density of about 10 holes per inch (ppi) to about 500 ppi, preferably about 100 ppi to about 300 ppi. In some embodiments, the protective panel 120 may include microperforations of various sizes, patterns, shapes, and / or in selected portions of the protective panel 120.

[0041] 9 shows an ostomy pouch with a protective panel 220 according to one embodiment, the protective panel 220 including a first set of microperforations 230 in a lower portion of the protective panel 220 and a second set of microperforations 232 disposed above the first set of microperforations 230. The first set of microperforations 230 may be defined by a plurality of openings having a diameter larger than the diameter of the second set of microperforations 232. For example, the first set of microperforations 230 may 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 232 may be defined by generally circular cylindrical openings having a diameter 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.

[0042] In one embodiment, the protective panel 220 may be formed from a copolymer film containing approximately 8% EVA and having a thickness of approximately 2.1 mils, and may include microperforations, including a first set of microperforations 230 defined by a plurality of openings having a diameter of approximately 380 μm arranged in two rows and a second set of microperforations 232 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 220 may be configured to block coarse particles and to heat seal to the pouch wall along its periphery. In some embodiments, the protective panel 220 may have slits or openings adjacent its lower periphery to allow any liquid accumulated between the protective panel and the pouch wall to drain.

[0043] Figure 10 is a partially exploded view of an ostomy pouch 400 according to one embodiment. The ostomy pouch 400 may be configured similarly to the ostomy pouch 100 and includes a filter assembly 416 and an optional multi-stage guard 417, which may include a protective panel 420 and a pre-filter 424. In the embodiment of Figure 10, the filter assembly 416 may be attached to the interior surface of the distal pouch wall 412. 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 to cover a gas exit opening 406 defined in the pouch wall 412 and may be attached to the pouch wall 412 in a manner that allows the membrane layer 404 to be positioned adjacent to the gas exit opening 406. In this embodiment, the filter assembly 416 and multi-stage guard 417 can be configured and arranged so that gas collected in the collection area flows through the micro-perforations 430 in the guard panel 420, through the pre-filter 424, then around the backing layer 402, radially through the filter media 418, and through the membrane layer 404 before exiting the ostomy pouch 400 through the outlet opening 406.

[0044] It should be understood that the relative directions discussed 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 should be 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.

[0045] All patents referenced herein are incorporated by reference in their entirety, whether or not specifically indicated in the body of this disclosure.

[0046] In this disclosure, the words "a" or "an" should be construed to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular.

[0047] From the foregoing, it will be appreciated that numerous modifications and variations can be effected without departing from the true spirit and scope of the novel concepts of the present invention. It is 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, the filter assembly including a backing layer, a filter media, and a membrane layer, the backing layer having a lower gas permeability than the filter media, and the membrane layer formed from a spunbond-meltblown-spunbond polypropylene (SMS PP) nonwoven fabric; An ostomy pouch comprising: The ostomy pouch, wherein the filter assembly is configured to have an air flow rate at 0.18 psi greater than 10 cc / s and less than 40 cc / s, and a water retention capacity greater than 0.9 psi and less than 6.0 psi.

2. 10. The ostomy pouch of claim 1, wherein the filter media is formed from activated carbon impregnated foam, the activated carbon impregnated foam being hydrophobic.

3. 3. The ostomy pouch of claim 2, wherein the filter medium is formed from activated carbon impregnated reticulated polyurethane (PU) foam.

4. The ostomy pouch of any one of claims 1 to 3, wherein the outlet is defined by an opening having an area of ​​between 0.06 square inches and 0.07 square inches.

5. 2. The ostomy pouch of claim 1, the backing layer is formed from a low density polyethylene film; The filter media has a saturation of 26 kg / m (tested according to ISO 845) ３ ~30 kg / m ３ and formed from activated carbon reticulated PU foam having a net density of the membrane layer is formed from an SMS PP nonwoven fabric having a basis weight of 44 gsm; the outlet is defined by an opening having an area of ​​between 0.06 square inches and 0.07 square inches; The ostomy pouch is configured to have an air flow rate at 0.18 psi greater than 10 cc / s and less than 40 cc / s, and a water retention capacity greater than 0.9 psi and less than 3.0 psi.

6. 2. The ostomy pouch of claim 1, the backing layer is formed from a low density polyethylene film; The filter media has a filtration capacity of 26 kg / m3 to 30 kg / m3 as tested according to ISO 845. ３ and formed from activated carbon reticulated PU foam having a net density of the membrane layer is formed from an SMS PP nonwoven fabric having a basis weight of 44 gsm; the outlet is defined by an opening having an area of ​​0.0625 square inches; The ostomy pouch is configured to have an air flow rate at 0.18 psi greater than 15 cc / s and less than 35 cc / s, and a water retention capacity greater than 1.0 psi and less than 2.0 psi.

7. 7. The ostomy pouch of claim 6, wherein the filter assembly is attached to an exterior surface of one of the body side wall and the distal side wall.

8. 8. The ostomy pouch of claim 7, wherein the filter assembly is configured to provide a radial gas flow path through the filter media, and 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 proximate an outer periphery of the filter assembly.

9. Further comprising a pre-filter and a protective panel; the pre-filter and the protective panel are configured to protect the filter assembly from ostomy waste; the filter assembly is attached to an outer surface of the distal sidewall; 9. The ostomy pouch of claim 7 or 8, wherein the pre-filter and the protective panel are attached to the inner surface of the distal sidewall.

10. 10. The ostomy pouch of claim 9, The ostomy pouch is configured to provide a flow path for the gas collected in the collection area to flow through microperforations in the protective panel, through the pre-filter, exit the ostomy pouch through the outlet, through the membrane layer, flow radially through the filter medium, and then exit the filter assembly.

11. The ostomy pouch of any one of claims 1 to 6, wherein the filter assembly is attached to an inner surface of one of the body side wall and the distal side wall.

12. 12. The ostomy pouch of claim 11, wherein the filter assembly is configured to provide a radial gas flow path through the filter media, the filter assembly being configured to allow the gas collected in the collection area to flow into the filter assembly through at least one gas inlet located proximate an outer periphery of the filter assembly, flow radially through the filter media, flow through the membrane layer, and then exit the ostomy pouch through the outlet.

13. Further comprising a pre-filter and a protective panel; the pre-filter and the protective panel are configured to protect the filter assembly from ostomy waste; 13. The ostomy pouch of claim 11 or 12, wherein the filter assembly, the pre-filter, and the protective panel are attached to an inner surface of the distal sidewall.

14. 14. The ostomy pouch of claim 13, The ostomy pouch is configured to provide a flow path for the gas collected in the collection area to flow through microperforations in the protective panel, through the pre-filter, enter the filter assembly through at least one gas inlet located near an outer periphery of the filter assembly, flow radially through the filter media, flow through the membrane layer, and then exit the ostomy pouch through the outlet.

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