METHODS AND APPARATUSES FOR OSTOMY GAS MANAGEMENT
A gas management system for use with an ostomy pouch includes an insert port defining an insert-receiving passage in communication with an inner chamber of an ostomy pouch and an exterior of the ostomy pouch. The insert port may be integrated into one or more walls of the ostomy pouch. An insert is selectively received in the insert-receiving passage of the insert port, the insert including at least one vent therein. An odor absorbent element is disposed in the insert. The insert-receiving passage and the vent of the insert defining a pathway for gases passing from the inner chamber of the ostomy pouch and through the absorbent material to pass out of the gas management apparatus. A guard may be supplied to carry a used insert upon removal from the insert port, as well as a replacement insert. The guard may have a wall to seal the used insert and the replacement insert. In certain embodiments, an applicator may be used to facilitate insertion of replacement inserts.
This application is a divisional application which claims priority to U.S. National Phase application Ser. No. 15/321,429, filed Dec. 22, 2016, which claims priority to International Application No. PCT/US15/37078, filed Jun. 23, 2015, which claims priority under 35 USC § 119(e) to U.S. provisional Application No. 62/016,069, filed Jun. 23, 2014, all of which are incorporated herein by reference in their entireties.
BACKGROUNDThis patent is directed to methods and apparatuses for gas management, and in particular to methods and apparatuses for use with ostomy products for gas management.
During a patient's normal use of an ostomy pouch, significant volumes of gas can accumulate within the pouch. In turn, this can cause a ballooning effect of the pouch, which can cause ostomates distress for a number of reasons.
The ballooning effect causes a discretion issue, as it is difficult to conceal the pouch under clothing. This is concerning in social environments, where individuals may want to keep their ostomy private.
The expanded pouch is uncomfortable both during the day and at night. For example, at night, one may roll over onto the pouch, potentially causing the pouch to detach from the abdomen, causing fecal output to spill everywhere. If pressure is sufficiently high, stool can sometimes escape through pores of the filter as well.
The collected gas is also significantly odorous, and this leads to further restrictions and embarrassment for ostomates. For example, ostomates will avoid traveling to visit family or friends because they do not want to release the odorous gas in foreign bathrooms. Furthermore, a common method for addressing ballooning is to uncouple the pouch and vent the collected gas, but this must be done in absolute seclusion due to the embarrassing gas odor that is released.
In order to avoid accidents such as these, ostomates will often wake up in the middle of the night to relieve the pressure, which causes a disruption of normal sleep patterns. The normal daily routine also suffers numerous disruptions as the ostomate must frequently visit the restroom or find secluded environments to empty the gas from their pouch. Lastly, ostomates will significantly alter their diet in order to reduce their gas production on a daily basis.
There are no current solutions that prevent gas ballooning or address gas odor for the entire wear period of each pouch in a hygienic, affordable and easy-to-use way. The most prevalent current product is a charcoal filter that is integrated into the pouch. Integrated filters have a tendency to foul during the first day. Because of this fouling problem, the filter does not function for the full wear period of the pouch, which is often four to seven days. Valve solutions also exist, which must be installed by the user and require active manual intervention by the user in order to work. These valves effectively function as emergency release valves after ballooning has already occurred, and they do not address odor.
As set forth in more detail below, the present disclosure describes apparatuses and methods for gas management useful with ostomy products, but may be useful elsewhere, embodying advantageous alternatives to the existing methods.
The disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the figures may have been simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omissions of elements in some figures are not necessarily indicative of the presence or absence of particular elements in any of the exemplary embodiments, except as may be explicitly delineated in the corresponding written description. None of the drawings are necessarily to scale.
The embodiments of the gas management apparatuses and methods described herein use material to absorb odorous gases, while optionally allowing the passage of other gases through. The odorous gases may include those produced by the intestine, such as hydrogen sulfide (H2S) and methyl mercaptan (MeSH). As a consequence, the gas management apparatus may prevent ballooning from occurring while minimizing user exposure to unpleasant odorous gases.
The embodiments of gas management apparatus include an insert (or unit, or filter (depending on the use of the insert)) and an insert port (or port). The insert port is attached (e.g., joined by adhesive or heat-seal or weld) to an ostomy product, such as an ostomy pouch. The insert port has a passage in which the insert is disposed. The passage is in communication with an inner chamber of the ostomy product, such that gases (and potentially other materials) contained in the ostomy product may pass from the inner chamber and into the insert port passage. The insert is disposed within the passage in such a way that most (e.g., at least 50%) if not all of the gases that pass into the passage also come in contact with the insert, and in particular with a portion of the insert formed of an odor absorbent. The insert port may include a latch that attaches or secures the insert in place in the passage.
It should be recognized that while in many of the embodiments of the gas management apparatus described below the insert port is open, such that gases flow into and through the passage and out of the ostomy product via the insert port, this may not be the case according to all embodiments of the present disclosure. For example, the insert port may be closed or capped, such that gases may enter the port, but are unable to exit the ostomy product. In such a circumstance, the odorous gases may still be exposed to the odor absorbent, thereby removing at least a portion of the odorous gases from the inner chamber of the ostomy product.
The insert is intended to be disposable, when the insert becomes fouled, such as when the individual using the ostomy product lies down, for example. In addition, more than one insert may be used with a single ostomy product over the life of the ostomy product. To this end, the insert may be used in conjunction or combined with an applicator that facilitates the removal and/or disposal of the existing insert and the placement of a new insert in the insert port. The applicator would enable these actions to be performed in a hygienic manner. For example, the applicator may cause the existing insert to be pushed through the passage in the insert port and into the inner chamber of the ostomy product (so that the insert may be disposed of with the intestinal wastes collected in the ostomy product), while a new insert is moved into place in the passage of the insert port. According to other embodiments, the insert may be detached from the port and disposed of in a refuse container.
The insert may include a liquid-impermeable, gas-permeable layer or membrane that encapsulates the odor absorbent. For example, as illustrated in
The odor absorbent used in the inserts describe herein may include, by way of explanation and not by way of limitation, activated charcoal, zeolites and metal-organic frameworks (MOFs).
Activated charcoal, zeolites and MOFs can be used to selectively sequester and store gas particles. Human gas is mainly comprised of nitrogen, carbon dioxide, methane, and hydrogen. The odorous portion of the gas is mainly comprised of hydrogen sulfide, methanthiol, and skatole, though they represent <5% of the output. It has been shown in the literature that these gases can be sequestered using activated charcoal, zeolites or MOFs.
Zeolites and MOFs have gas storage capacities that may be particularly favorable. It is documented that the storage capacities of up to 4 mmol/kg (mmol gas per kg of media) can be achieved with zeolites and/or MOFs.
While zeolites and MOFs have a well-documented ability to adsorb gases, their overall shape, weight, and potential for hydrophobicity permits their advantageous use in, for example, ostomy products as described herein. Hydrophobicity may be particular important as commercially-available gas management technology for ostomy pouches are believed to cease function post-contact with liquid.
The embodiments described herein may use a particular type of activated charcoal, zeolite or MOF, or may use a combination of activated charcoal, zeolites and/or MOFs together to capture the heterogeneous gas mixture that frequently comprises ostomy output.
The membrane that surrounds the gas adsorbent is microporous membrane (such as ePTFE Gore-Tex) that may be hydrophobic and oleophobic, but is gas permeable. This membrane serves to protect the gas adsorbent from intestinal output on the interior of the pouch. This membrane also serves to protect the gas adsorbent on the exterior portion of the pouch from things such as water or sweat from daily activities. Due to the porous nature of the material, passage of gases through the filter can still occur. The filter can be comprised of membrane/adsorbent/membrane as shown in
As mentioned above, the gas management apparatus may also be capped. According to such an embodiment, a MOF that specifically adsorbs both odorous and volumous gases produced by the intestine (primarily hydrogen (H2), nitrogen (N2), methane (CH4) and carbon dioxide (CO2) may be used because there will be minimal or no outflow of any gases. An embodiment of an insert for such a capped apparatus may follow similar geometry as above with a protecting microporous membrane over the internal aspect of the unit, protecting the MOF from intestinal output. The external aspect of the unit would be solid material (i.e. plastic) that does not permit the passage of gases or liquids (e.g. acts as a “cap”). The cap would protect the contained MOF from external elements, and it would also protect the user and environment from possible exposure to pouch contents by preventing leakage of intestinal output and odor.
In fact, the port may be capped using an insert that does not permit through-passage of gas during those times when ostomates may wish to not vent, for example, when they are sleeping or showering.
As also best seen in
As seen in
Alternatively, the inserts 40 can be applied to the port 30 using an applicator 60 such as what is shown in
The applicator 60 could also be composed of dissolvable or rapidly-degrading material, such that it is safe to flush into the septic system, to improve user discretion in public settings.
In the diagram, the applicator 60 is held in place via the hub 68 (see
In this embodiment, old inserts (and their housing) are thrown away after replacement.
The insert 80 may be used with a guard (or carrier) 90 to facilitate disposal of the user insert while providing a new replacement. As seen in
According to this embodiment, the insert housing also snaps onto the port integrated to the pouch. The insert housing geometry keeps fecal matter stuck on used units far from the hands of the user, as the innermost edge of the hub 112 (where feces would collect) is shorter in length that the outwardmost edge of the skirt 114 that is handled by the user's fingers. An optional additional barrier for unit protection may be disposed at 118. The optional barrier may be a gas-permeable, liquid-permeable membrane such as the membrane used to encapsulate the odor absorbent, to prevent water collection in the cavity 119 that could occlude airflow. Alternatively, the insert can fill the entire space of the cavity, allowing for multiple layers that can aid in leak prevention.
The “eye-shaped” geometry of the port allows for easy sealing of the port between the two pouch walls at the top portion of the pouch (see
This port is placed at the top portion of ostomy pouch, between the two layers of plastic that comprise the pouch walls, as gas rises to the top of the pouch when a person is upright during the day. This position is also easiest for ostomates to see while the pouch is on their body, in order to handle the product during filter replacement.
As shown in
A middle wall 122 (see
Alternatively, the new guard itself can serve as that means for handling, as shown in
The components for the embodiment of
Using an oblong shape for the port 130 may permit for a more slim profile while maintaining enough surface area to allow for significant gas flow. In this embodiment, the outer walls of the port 130 are adhered or heat sealed to the pouch walls, such that the only portion that sticks out of the pouch is the rim on the unit housing. In order to facilitate handling of the unit housing, ridges that create texture or a tacky coating (such as silicone) on the outer rim (not shown) can be added.
Unlike, the port 100 and insert 110, the wall of the port 130 is not received between a hub and a skirt of the insert 110. Instead, the wall of the hub 142 of the insert 140 is received between inner and outer walls 132, 134 of the port 130, with a latch 136 (which may be in the form of a pair of facing ridges formed on facing surfaces of the inner and outer port walls 132, 134) provided to capture a ridge 144 formed at the innermost edge of the hub 142 to limit the ability of the insert 140 from being removed from the port 130. The cooperation between the latch 136 and the ridge 144 aids the user when installing/removing by creating a gradual sliding mechanism that ultimately pops into or out of place. One or more additional ridges 138 may be provided on the inner and/or outer walls 132, 134 below (i.e., further inwardly of) the first set of ridges that defines the latch 136, the ridges 138 assisting in maintaining a seal and from the user attempting to push too far. This configuration creates a tangible sensation and/or an auditory sensation (e.g. a “click”) to assure the user that the unit has been properly installed. Ridges on the port 130 and the insert 140 may be created using the same material as the port 130 and the insert 140, or using o-rings.
An o-ring 160 below the ridges 138 between the walls 132, 134 also aids in sealing the insert 140 to the port 130. The o-ring 160 is dimensioned such that it is flush against the insert housing and port. Pressure from the insert causes expansion of the o-ring radially, creating a seal. Of course, other or additional mechanisms for sealing may be provided to make to ensure that fecal matter does not leak (a concern for ostomates). For example, an outer edge 146 of the insert 140 may be flush against an outermost edge of the port to create a seal.
The insert outer edge 146 of the insert 140 may be in the form of an outwardly-directed lip region. The insert 140 may further be defined by an inwardly-directed lip region. At least a portion of the outer wall 134 is taller than the inner wall 132. The outwardly-directed lip region engages a top of the outer wall 134 and an odor absorbent element 116 is secured intermediate the inner wall 132 of the insert port 130 and the inwardly-directed lip region of the insert 140.
The outer, curved lip of the port will be used to provide a means to attach the port to the pouch. A seal can be achieved through adhesive or heat-sealing methods around the entire rim of the port. The curved edges facilitate in creating that seal, as any corners would provide a risk for leakage of odor or output.
It will be recognized that according to the specific nature of a particular embodiment, one of more of the following issues may need to be addressed:
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- Minimize contact of adsorbent to gas prior to intended use
- Allow the user to implement it in a sanitary way
- Maximize direct contact of adsorbent with gas in pouch
- Minimize contact of adsorbent with liquid/feces in pouch
- Function after exposure to fluids between pH 5.8 and 6.8
- Be non-toxic to skin or the stoma
According to any one or more of the embodiments described herein, one or more of the following advantages may be realized:
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- Works in the presence of liquid
- Decreases gas odor AND volume
- Extends time between ostomy pouch evacuation
- Improves performance (of volume reduction) at typical operating conditions
Further, it will be recognized that one or more of the embodiments described herein may be used in the following alternate environments:
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- Diapers, diaper pails—for odorous gas adsorption
- Bathroom deodorizers—for odorous gas adsorption
- Waste management systems—for odorous gas adsorption
- Chux—for odorous gas adsorption
- Bedside commodes and bedpans—for odorous gas adsorption
- Pet training pads & waste management—for odorous gas adsorption
- Industrial gas purification systems—for gas separation or storage
In conclusion, the detailed description is to be construed as exemplary only and does not describe every possible embodiment of the invention since describing every possible embodiment would be impractical, if not impossible. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent, which would still fall within the scope of the claims defining the invention.
It should also be understood that, unless a term is expressly defined in this patent using the sentence “As used herein, the term ‘______’ is hereby defined to mean . . . ” or a similar sentence, there is no intent to limit the meaning of that term, either expressly or by implication, beyond its plain or ordinary meaning, and such term should not be interpreted to be limited in scope based on any statement made in any section of this patent (other than the language of the claims). To the extent that any term recited in the claims is referred to in this patent in a manner consistent with a single meaning, that is done for sake of clarity only so as to not confuse the reader, and it is not intended that such claim term be limited, by implication or otherwise, to that single meaning. Finally, unless a claim element is defined by reciting the word “means” and a function without the recital of any structure, it is not intended that the scope of any claim element be interpreted based on the application of 35 U.S.C. § 112, sixth paragraph.
Claims
1. A gas management apparatus for use with an ostomy pouch, comprising:
- an insert port defining an insert-receiving passage in communication with an inner chamber of an ostomy pouch and an exterior of the ostomy pouch, the insert port being integrated into one or more walls of the ostomy pouch;
- an insert selectively received in the insert-receiving passage of the insert port, the insert including at least one vent therein; and an odor adsorbent element disposed in the insert, the insert-receiving passage and the vent of the insert defining a pathway for gases passing from the inner chamber of the ostomy pouch and through the adsorbent material to pass out of the gas management apparatus; and
- a gas impermeable barrier received in each of the at least one vent of the insert.
2. A gas management apparatus for use with an ostomy pouch, comprising:
- an insert port defining an insert-receiving passage in communication with an inner chamber of an ostomy pouch and an exterior of the ostomy pouch, the insert port being integrated into one or more walls of the ostomy pouch;
- an insert selectively received in the insert-receiving passage of the insert port, the insert including at least one vent therein; and an odor adsorbent element disposed in the insert, the insert-receiving passage and the vent of the insert defining a pathway for gases passing from the inner chamber of the ostomy pouch and through the adsorbent material to pass out of the gas management apparatus, the insert port including a latch at least partially defining an insert-receiving slot, the slot having a curvature complementary to a curvature of the insert, preventing leakage between the insert and the insert port.
3. The gas management system of claim 2, the latch including one or more ramps to facilitate insertion of a replacement insert.
4. The gas management system of claim 2, wherein upon insertion of a replacement insert, a replaced insert falls into the ostomy pouch.
5. A gas management apparatus for use with an ostomy pouch, comprising:
- an insert port defining an insert-receiving passage in communication with an inner chamber of an ostomy pouch and an exterior of the ostomy pouch, the insert port being integrated into one or more walls of the ostomy pouch;
- an insert selectively received in the insert-receiving passage of the insert port, the insert including at least one vent therein; and an odor adsorbent element disposed in the insert, the insert-receiving passage and the vent of the insert defining a pathway for gases passing from the inner chamber of the ostomy pouch and through the adsorbent material to pass out of the gas management apparatus; and
- an applicator that carries one or more replacement inserts, the applicator having an opening permitting insertion of one of the one or more replacement inserts into the insert port.
6. The gas management system of claim 5, further comprising a pusher disposed in the applicator, the pusher received in a pusher-receiving bay of the applicator, the pusher facilitating insertion of one of the one or more replacement inserts into the insert port.
Type: Application
Filed: Apr 15, 2020
Publication Date: Jul 30, 2020
Inventors: Joan C. Apolinario (Evanston, IL), Rachel J. Blumberg (San Francisco, CA), Whitney R. Halgrimson (Chicago, IL)
Application Number: 16/849,917