KR20160033658A - Gas filter and release for ostomy appliance - Google Patents

Abstract

The open mouth mechanism components provide filtered drainage of gas from the surgical pores. The filter configuration, positioning, positioning structure is related to the potential benefits of operation and manufacturing of the components.

Description

TECHNICAL FIELD [0001] The present invention relates to a gas filter and an exhaust device,

Related application

This application is related to U.S. Provisional Patent Application No. 61 / 903,523, filed November 13, 2013, U.S. Provisional Patent Application No. 61 / 884,256, filed September 30, 2013, filed on May 9, 2013, U.S. Patent Application No. 13 / 890,433, and International Patent Application No. IL2013 / 050401 filed on May 9, 2013, the entire contents of which are incorporated herein by reference in their entirety.

This application is related to U.S. Provisional Patent Application No. 61 / 645,118, filed May 10, 2012, the entire contents of which are incorporated herein by reference in their entirety.

The present invention, in some embodiments of the present invention, relates to the field of medical treatment for surgically created openings (stomas) in living patients, and more particularly to the fields of colostomy, The present invention relates to an apparatus and a method for coating a stoma such as can be used in the case of ileostomy or urostomy.

In ostomy surgery, it is surgically adhered to the pores in the abdominal wall of the healthy part of the intestine. Adhesion may be on the internal surface, or the surgeon may pass the intestine through the pore and attach it to the outside of the abdominal wall. Colon or small intestine is attached, which depends on the type of ostomy that makes artificial perforation.

When the intestinal contents can no longer be defecated by the anus, the pores can remain permanently in the patient, which may be due to, for example, colon cancer, diverticulitis, trauma, inflammatory bowel disease. The pores may be transient, depending on the operation, for example, for the incision of the intestines requiring a period of healing.

The use of an open mouth device is indicated to the patient with a pore, to help manage the pore excreta. Depending on the nature of the pore, the pore excrement includes, for example, excrement, urine, and / or mucus. The device may be fully external, or at least partially embedded. A typical element of a pore device includes a pouch for collecting pore excreta and means for sealing the pouch over the pore. In some cases, a plug or cover is additionally or alternatively used in the pouch.

The described open mouth mechanism design includes:

U.S. Patent Application Publication 2007/0191794 relates to a controlled excretion enhancer that includes a membrane that is compressed to create a seal with the pores by the generation of a radial tension of the membrane. The tensioning device applies tension to the pores at one or more locations that are (1) outside of the perimeter of the protrusion of the pores and / or (ii) at a level between the level of the dermal skin and the level of the extruded portion of the pore. Tension limiting means is disclosed. The membrane is permeable to gas so that it can pass through it.

U.S. Patent Application Publication No. 2004/0181197 relates to a flexible membrane located within a rigid or semi-rigid cap. The edge of the cap wall is adhered and fixed to the tissue surrounding the pore. The interior of the cap is pressed against the excrement of rigid and semi-solid waste to press the membrane to seal the pores. The gas exits through the vent with the filter element. The cap may be pressurized by an integral pump member located at the top of the external pump or cap. The relief valve prevents excessive pressure. The import pouch may be provided as part of the device. The device can be removably mounted on a standard two-piece face plate.

U.S. Patent No. 6,689,111 relates to a balloon-shaped member that is accommodated in the interior and is inflated to seal a stoma. The member includes a thin flexible wall defining an opening. A rigid or semi-rigid cap holds the member and blocks the opening of the member wall. A skin-friendly adhesive attaches the edge of the cap to the tissue around the pore. A flexible extension tube facilitates insertion of the expansion member and cooperates with the pump to expand the member. Preferably, the stopper is removably attached to a standard two-part open-mouth front face plate and has a filter element for discharging the fart.

According to an aspect of some embodiments of the present invention there is provided an open mouth mechanism having a gas discharge valve comprising: an orifice sidewall sidewall defining a portion of a fence for stoma, the sidewall having a through- , Spinal instrument side wall; A stopper positioned across the majority of the passage through the aperture in the side wall and positioned to block gas flow through the aperture and a control member actuable from the outside of the aperture mechanism for unblocking the aperture, Wherein the valve member comprises a valve member, wherein the valve member comprises a valve member.

According to some embodiments of the present invention, the valve member includes a connecting member connecting the stopper to the control member across the aperture.

According to some embodiments of the present invention, the stopper, the control member, and the connecting member are integrally formed.

According to some embodiments of the present invention, the connecting member is resilient and urges the stopper to the closed position under tension.

According to some embodiments of the present invention, the lumen side wall is compressively deformed with respect to the stopper at the closed position.

According to some embodiments of the present invention, an opening mechanism having a gas discharge valve includes a spring for urging the stopper to the closed position upon compression.

According to some embodiments of the present invention, an opening mechanism having a gas discharge valve includes a spring that urges the stopper to the closed position upon tension.

According to some embodiments of the present invention, the stopper, the control member, and the spring are integrally formed.

According to some embodiments of the present invention, the stopper includes a filter body that provides a portion of the passage for crossing gaseous outflow of the lumen side wall, and the occlusion position includes a gas outlet passing around the filter body prevent.

According to some embodiments of the present invention, the gas outflow is only blocked below a predetermined threshold of safety internal pressure.

According to some embodiments of the present invention, the internal pressure of the open mouth mechanism urges the stopper to move the stopper from the occlusion position above a predetermined threshold of pressure.

According to some embodiments of the present invention, the predetermined threshold of the safety internal pressure is between 50 mmHg and 100 mmHg.

According to some embodiments of the present invention, the occlusion position includes the stopper being pressed against the inner surface of the lumen sidewall.

According to some embodiments of the present invention, the occlusion position includes the stopper pressed against the outer surface of the lumen sidewall.

According to some embodiments of the present invention, the stopper includes a member that extends substantially through the aperture, and the operation of moving the stopper out of the closed position includes rotation.

According to some embodiments of the present invention, the control member includes an outer lever attached to the extension member, and the lever is operable to rotate the extension member of the stopper such that the gas is dischargeable.

According to some embodiments of the present invention, the stopper includes a region extending toward one end of the valve member, and the occlusion position is at least partially inserted into the through hole to form a seal together, End.

According to some embodiments of the present invention, the pores are separated from the stopper by a gas-permeable sealing element.

According to some embodiments of the present invention, said detachment includes blocking from reaching said stopper of solid and liquid excrement from said pores.

According to some embodiments of the present invention, the lumen sidewall comprises a thickness of at least 3 mm, through which the connecting member extends.

According to an aspect of some embodiments of the present invention, an open instrument having a filter element comprises: a sidewall defining a first lumen surrounding a pore; And a first filter element held in at least a second lumen, the second lumen being a passage in the side wall connecting the first lumen outside the open mouth mechanism do.

According to some embodiments of the present invention, the wall of the second lumen includes portions of the base element and the cover element; The filter element contacting both the base element and the cover element; And the base element and the cover element are directly attached to each other on either side of the filter element.

According to some embodiments of the present invention, the second lumen includes a pocket region padded by portions of the base element and the cover element; And the base element and the cover element enclose the filter element within a circumferentially extending pocket closed on at least two outer peripheral sides.

According to some embodiments of the invention, the end of the first lumen is closed, and the aperture in the side wall is coplanar with the inner surface of the closed end.

According to some embodiments of the present invention, the cover element is inserted into the recess of the base element to form the second lumen.

According to some embodiments of the present invention, the filter element is replaceable within the second lumen during operation of the open mouth mechanism.

According to some embodiments of the invention, an input channel in fluid communication with the input surface of the filter element separates the input surface from the first lumen.

According to some embodiments of the present invention, the input channel includes a membrane material attached over the base element.

According to some embodiments of the invention, the input channel includes a recessed surface that is covered by a closure element to form a lumen.

According to some embodiments of the invention, the input channel comprises hydrophobic surfaces.

According to some embodiments of the present invention, the hydrophobic surfaces comprise apertures that are small enough to block the water under its own weight of pressure to a depth of the radius of the first lumen.

According to some embodiments of the invention, the input channel includes at least one valve between the input surface and the first lumen, wherein the input channel is closed when the pressure outside the input channel rises relative to the pressure inside the input channel do.

According to some embodiments of the present invention, the input channel includes at least one valve between the input surface and the first lumen, which is opened when the pressure outside the input channel rises relative to the pressure inside the input channel do.

According to some embodiments of the invention, the valve is a flutter valve.

According to some embodiments of the invention, the filter element projects into the first lumen.

According to some embodiments of the present invention, the filter element includes an open area through which the sidewall base element and the cover element are directly connected.

According to some embodiments of the present invention, the entire input surface by which gas enters the filter element from the first lumen is radially outward from the closest portion of the exit surface from which the gas exits the filter element externally It is shifted.

According to some embodiments of the present invention, the second lumen includes portions of the sidewall molded around the filter element.

According to some embodiments of the present invention, positioning of the filter element does not interfere with the flow of excreta through the first lumen.

According to some embodiments of the present invention, an open mouth mechanism having a filter element includes a fecal collection bag, wherein the first lumen is configured to carry excreta to enter the excreta collection bag, Provide a channel to avoid the pocket.

According to some embodiments of the invention, the input surface of the filter element on the side of the first lumen extends at least five times the range of the surface in one direction and in the other direction.

According to some embodiments of the invention, at least one surface of the filter element is laminated.

According to an aspect of some embodiments of the present invention there is provided a method for manufacturing an opening mechanism for retaining a filter element, the method comprising: positioning a filter element against an end portion of a sidewall defining a lumen of a first retaining portion Placing; Disposing a second retaining portion for the filter element and the first retaining portion; And attaching the first retaining portion and the second retaining portion together such that the filter element is retained between the first retaining portion and the second retaining portion, / RTI >

According to some embodiments of the present invention, the attaching step is by squeezing the first holding part and the second holding part with a welding tool.

According to some embodiments of the present invention, the welding tool does not squeeze on at least one of the first holding portion and the second holding portion over the area of the filter element.

According to some embodiments of the present invention, the welding tool squeezes at a reduced pressure on the first holding portion and the second holding portion above the area of the filter element.

According to some embodiments of the present invention, the welding tool does not seal the first holding portion and the second holding portion together on an area extending from the lumen of the first holding portion to the filter element.

According to an aspect of some embodiments of the present invention, there is provided a method for manufacturing an opening mechanism for retaining a filter element, the method comprising: disposing a second retaining portion relative to a side wall defining the lumen of the first retaining portion included in the opening mechanism ; Attaching the first retaining portion and the second retaining portion together such that a through hole sized to hold the filter element therebetween is left; And inserting the filter element into the aperture, so that the body of the filter element includes a main path of gas conduction through the aperture.

According to some embodiments of the present invention, the attaching step is performed by squeezing the first holding portion and the second holding portion with a welding tool.

According to some embodiments of the present invention, the welding tool does not squeeze on at least one of the first holding portion and the second holding portion over the area of the filter element.

According to some embodiments of the present invention, the welding tool is squeezed with a reduced pressure on the first retaining portion and the second retaining portion over the area of the aperture.

For example, according to an aspect of some embodiments of the present invention, including any of the embodiments described herein, an open cap for sealing a surgical stoma, A surgical excrement collection pouch folded into a package containing parallel layers by corrugated folding and having a slurry inlet into the first sub-panel; And a second sub-panel of the pouch detached from the first sub-panel by corrugated folding, configured to receive a flatus in the body reaching from the excrement entrance of the pouch and to exhaust gas in the stomach out of the pouch An opening cap for sealing a surgical pore is provided, which includes a filter element that is sealed across a break in the material.

For example, according to some embodiments of the present invention, including any of the embodiments described herein, the first sub-panel and the second sub- And by a crease which is located above and above the filter element.

For example, according to some embodiments of the present invention, including any of the embodiments described herein, the side of the second sub-panel to which the filter element is attached has a substantially parallel surface So as to overlap on the outer side of the pouch.

For example, according to some embodiments of the present invention, including any of the embodiments described herein, corrugated folds include areas that resist flow of fluid into the second sub-panel.

For example, according to some embodiments of the present invention, including any of the embodiments described herein, the predetermined pressure level is between 1 mmHg and 10 mmHg.

Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in practice or in testing of embodiments of the present invention, the illustrated methods and / or materials are described below. In the event of a conflict, a patent specification containing definitions will be adjusted. In addition, the materials, methods, and examples are illustrative only and are not necessarily intended to be limiting.

Some embodiments of the invention are described herein by way of example only with reference to the accompanying drawings. Referring now in particular detail to the drawings, it is emphasized that the particular features shown are by way of example and for the purposes of illustration of the embodiments of the invention. In this regard, the description through the drawings will be apparent to those skilled in the art how an embodiment of the invention may be carried out. In the drawing:
Figure la schematically illustrates an exploded perspective view of an open mouth mechanism including an integrated gas filter and a filter support area, in accordance with some exemplary embodiments of the present invention.
Figure 1b schematically illustrates a cross-sectional view of the open mouth mechanism of Figure Ia, in accordance with some exemplary embodiments of the present invention.
Fig. 1c shows, in an enlarged scale, the gas filter and cap housing of Fig. 1a according to some exemplary embodiments of the present invention.
Figure 2 schematically illustrates an exploded perspective view of an open mouth mechanism with an integrated gas filter, in accordance with some exemplary embodiments of the present invention.
3A schematically shows a perspective view of an open-top cap housing with a filter element, including a structure for filtering the inlet of the filter, according to some exemplary embodiments of the present invention.
Figure 3b schematically illustrates a perspective view of a portion of the cap of Figure 3a attached to a membrane material that closes the openings of the excrement filtration channel and the inlet element, in accordance with some exemplary embodiments of the present invention.
Figure 3c schematically illustrates a perspective view of a portion of the cap of Figure 3a pressed against a face-closing structure that closes the opening of the excretory filtration channel and inlet element, according to some exemplary embodiments of the present invention.
Figure 4A schematically illustrates an exploded perspective view of an open subassembly including a pouch and a cap housing together with a welding tool portion used in the manufacture of the cap subassembly, in accordance with some illustrative embodiments of the present invention.
Figures 4B-4D schematically illustrate operation of a welding tool portion with a recess for assembling a filter in an open housing, in accordance with some illustrative embodiments of the present invention.
Figure 4e schematically illustrates a perspective view of gas exiting an open cap subassembly including a cap housing and a pouch bonded to the filter, in accordance with some exemplary embodiments of the present invention.
Figures 4f-4g schematically illustrate cross-sectional views of an open cap subassembly in accordance with some exemplary embodiments of the present invention, showing details of the operation of the flutter valve.
Figures 5A-5C schematically illustrate a front view of a filter element having a shape adapted to different filtration and / or positioning requirements, according to some exemplary embodiments of the present invention.
Figure 6 schematically illustrates an exploded perspective view of a cap subassembly of an open mouth mechanism including a housing configured to filter gas entering a filter element, in accordance with some exemplary embodiments of the present invention.
Figure 7 schematically illustrates an exploded perspective view of a cap subassembly of an open mouth mechanism including a housing configured to form a minimal length path of a gas flow filtered across a relatively narrow flange, according to some exemplary embodiments of the present invention. Respectively.
Figure 8 schematically illustrates a perspective view of a filter cap and an opening cap housing having a shape adapted to a plurality of filtering and / or positioning requirements, in accordance with some exemplary embodiments of the present invention.
Figures 9A and 9B schematically illustrate a pre-formed recessed filter element retention structure and a pre-formed recess free filter element retention structure, in accordance with some exemplary embodiments of the present invention.
10A schematically illustrates an exploded perspective view of a cap subassembly including a planar folded pouch and a planar filter element attached side by side to the surface of the cap housing, according to some exemplary embodiments of the present invention.
Figure 10b schematically illustrates a perspective view of the subassembly of Figure 10a with a cap cover formed into a shape to receive the pouch and filter element, according to some exemplary embodiments of the present invention.
Figure 11 schematically illustrates a perspective view of a cap housing having a planar filter element configured to removably retain within a recess of the cap housing, in accordance with some illustrative embodiments of the present invention.
Figure 12a schematically illustrates a perspective view of a cap housing with a planar filter element configured to be inserted into a recess of a cap housing and fixed to at least one side by an insertion element, according to some exemplary embodiments of the present invention. .
Figure 12b schematically illustrates a perspective view of a cap housing with a planar filter element configured to be retained in the aperture of the cap housing, according to some exemplary embodiments of the present invention.
Figure 12C schematically illustrates a cross-sectional view of a wafer and an open mouth instrument housing comprising a planar filter element embedded in the housing by overmolding, in accordance with some exemplary embodiments of the present invention.
13A schematically illustrates an exploded perspective view of an open dental appliance dummy including a gas filter and a hand gas discharge valve stem, in accordance with some illustrative embodiments of the present invention.
Figure 13b schematically illustrates a cross-sectional view of an open dummy instrument stack of Figure 13a, in accordance with some exemplary embodiments of the present invention.
Figure 13c schematically illustrates an enlarged perspective view of the manual gas discharge valve stem of Figure 13a, in accordance with some exemplary embodiments of the present invention.
Figure 14a schematically illustrates a perspective view of a gas discharge valve stem portion, in accordance with some exemplary embodiments of the present invention.
Figure 14b schematically illustrates a perspective view of a gas discharge valve stem portion, in accordance with some exemplary embodiments of the present invention.
Figures 15A-15C schematically illustrate configurations of a gas discharge valve, according to some exemplary embodiments of the present invention.
16A and 16B schematically illustrate a manual gas discharge valve, in accordance with some exemplary embodiments of the present invention.
16C and 16D schematically illustrate a manual gas discharge valve, in accordance with some exemplary embodiments of the present invention.
Figure 17a schematically depicts a filter element positioned to discharge through the material of an open pouch, according to some exemplary embodiments of the present invention.
Figure 17b schematically illustrates a detailed structure of a filter element according to some exemplary embodiments of the present invention.
Figures 17C-17E schematically illustrate the position of the filter in relation to the folding structure of an open pouch in accordance with some exemplary embodiments of the present invention.
18A-18B illustrate other configurations of filters attached to pouch embodiments in accordance with some exemplary embodiments of the present invention.
Figures 18c and 18d illustrate a filter element having at least one side that is protected from fecal contamination by a sealing element, according to some exemplary embodiments of the present invention.
Figures 19a and 19b illustrate cross-sectional views of an open mouth mechanism including a flap valve, in accordance with some exemplary embodiments of the present invention.
Figures 20a-20c illustrate views of an open mouth mechanism including a valve protected from a pore effluent by a secondary sealing member, in accordance with some exemplary embodiments of the present invention.

The present invention relates, in some embodiments thereof, to the field of medical care for surgically created openings (stomas) in a living subject, and more particularly to the field of colostomy, to an apparatus and method for covering a pore, such as can be used in the case of ileostomy or urostomy.

summary

Embodiments of some embodiments of the invention relate to the evacuation of stomal gasses through the luminal side wall of an open mouth mechanism.

In some embodiments, the lumen sidewall is part of an open mouth mechanism, including a fenestration enclosure for controlling the passage of waste therefrom. The fence, in some embodiments, includes a covering for the outer portions of the pores. In some embodiments of the invention, the luminal side wall includes a passageway for evacuating pressurized gas from a digestive tract. Allowing the discharge of gas exiting the covered surgical pores reduces the internal pressure maintained by the open mouth mechanism. In some embodiments, the gas is filtered in the exhaust passageway to reduce fecal odors that the gas may have. Additionally or alternatively, slowing the gas discharge through the filter would reduce the odorant concentration.

In some embodiments, the liquid and / or solid waste may be retained within the pore and / or pore fences during the continent phase of opening the mouth mechanism. In some embodiments, the liquid and / or solid waste is discharged into an open ostomy pouch during the evacuation phase of the open mouth operation. Optionally, the pouch is folded and held closed during the inhibition period. Optionally, the pouch is deployed to receive waste. Optionally, the pouch filled with waste continues to be mounted until the pouch can be emptied. Optionally, the pouch is not deployed until the ostomate is in a condition that allows the pouch to be immediately emptied or replaced.

In some embodiments, the filter element is retained within the aperture of the lumen side wall of the at least one open instrument component. The apertures are formed, for example, from an open mouth cap, adapter, wafer and / or waste collection pouch. In some embodiments, the aperture walls also guide the gas to and / or through the filter element. The potential benefit of the filtered exhaust of the vented gas through the luminal side wall of the open mouth mechanism is the reduced cost and / or reduced manufacturing complexity for the filter held by the components of the open instrument wall.

One aspect of some embodiments of the present invention relates to the manufacture of an open mouth mechanism that releases gas through the luminal side wall.

In some embodiments of the invention, the filter element extends over only a portion of the thickness and / or circumference of the opening instrument wall. If possible, this reduces the manufacturing cost and / or allows the walls to be reinforced to enhance the opening mechanism.

One aspect of some embodiments of the present invention relates to providing a filter that is held between a plurality of support layers.

In some embodiments of the present invention, the aperture for holding the filter includes two open spoken parts. In some embodiments, the two parts form a pocket that surrounds the filter element on at least two sides. In some embodiments, the two parts are directly bonded to each other. In some embodiments, the opening comprises a surface of a membrane structure, such as a feces collection pouch film. Optionally, the filter is attached at a predetermined location, for example welded or glued to form a hermetic seal around its side. Additionally or alternatively, the hermetic seal is formed by compression. Optionally, the filter element may be removed and / or replaced while the open mouth parts are in use.

One aspect of some embodiments of the present invention is directed to providing a planar filter element retained in a luminal side wall.

In some embodiments, the cross-section of the filter element through the lumen sidewall has an aspect ratio of 5 to 1 or greater (maximum to minimum intersecting length). In some embodiments, the planar filter element has a sufficiently flat surface and is extended to receive a laminated membrane that limits the passage of gas.

One aspect of some embodiments of the present invention relates to maintaining adequate gas release and / or filtration capabilities in potentially contaminated environments.

In some embodiments, a strainer separates liquid and / or solids from the excrement before gaseous pore effluent reaches the filter element. If possible, filtering out the inlet portion reduces or prevents clogging of the gas receiving surface of the filter with liquid and / or solid, thereby prolonging the life of the filter element.

In some embodiments, the filter includes a patterning attachment for the other surface of one surface. The surfaces are, for example, excrement collection pouch films attached to open mouth parts housings. In some embodiments, one solid element is formed in a shape to hold and / or protect the filter, for example, by boring, excavating, or molding. Optionally, the shaping of the solid element comprises a structure for inlet filtration.

In some embodiments, the filter includes a gas inlet aperture sized to exclude the ingress of solids and / or liquid excreta. In some embodiments, a plurality of inlet apertures are provided. In some embodiments, the opening is spaced from the filter inlet surface by a channel. In some embodiments, the spacing includes disposing a filter element at the outer edge of the pocket surrounding the filter element. In some embodiments, the channel is completely or partially circumferential. Optionally, the channel provides a plurality of paths from one or more filter inlet holes to a filter inlet surface. Optionally, the arrangement of inlet openings and / or channels is configured to provide perforations distributed around the perimeter.

Alternatively, the inlet aperture is narrow enough to exclude solid excrement in size and / or narrow in surface tension to inhibit fluid excrement intrusion. In some embodiments, the filter surface comprises a hydrophobic material. Possibly, the hydrophobicity resists penetration of liquid excrement. In some embodiments, the flexible structure causes the external pressure to constrict the gas inlet aperture, thereby preventing the gas inlet aperture from leaking. In some embodiments, the external pressure on the gas inlet aperture opens a through hole that is normally closed. In some embodiments, the arrangement of the inlet apertures and / or channels is configured in relation to gravity, for example when the apertures are located at a higher position on the open mouth mechanism and / Additional protection is provided.

In some embodiments of the present invention, the gas receiving surface area of the filter element is increased by molding of the filter element edge. For example, the filter element is shaped to have edge ridges and / or protruding features. If possible, the additional gas receiving area maintains the filter function even when surface contamination occurs.

One aspect of some embodiments of the present invention relates to valve-controlled gas release.

In some embodiments, the gas discharge valve includes a closable aperture in the housing sidewall or end cap wall of the open instrument housing. In some embodiments, the valve includes a member attached to a control such as, for example, a lever, a handle, or a button; The member is configured to enter the gas discharge aperture. In some embodiments, the member places a sealing element that occludes gas emissions from the opening, and the occlusion is removable by manipulating the control. In some embodiments, the penetrating member itself seals the through-hole, but it can move to allow the gas to escape by deforming the through-hole. In some embodiments, the valve limits gas release, but allows leakage under at least some pressure conditions, such as, for example, a safety gas release mechanism.

One aspect of some embodiments of the present invention relates to the construction of a filtering element with an open pouch that allows the filter to perform an act of releasing gas while the open pouch is folded.

In some embodiments of the invention, the filter is disposed within a designated area of the open pouch. Optionally, the open pouch may be folded, e.g., folded, more specifically folded into a corrugated panel, or, more specifically, substantially the same size as the largest panel (e.g., An area which is made to function when folded into a corrugated panel including a plurality of panels is selected.

In some embodiments of the present invention, the folding pouch has a plurality of panels (regions divided by pouch boundaries and / or folded boundaries) that are substantially parallel within the pouch, and the number of panels may be, for example, , 4, 9, 12, 16, 18, 20, or 40, or more, fewer, or intermediate. In some embodiments of the present invention, the folding pouch has a plurality of pleated regions, wherein the direction of the pouch material is folded about 180 degrees through the pleated region and the number of pleats is, for example, 1, 2, 3 , 4, 5, or 6, or more. In some embodiments of the present invention, the one or more pleated regions include a change over about ninety degrees in the direction of the pouch material, including, for example, a box shape, an accordion shape, Are placed vertically on the other set of panels or in another form. In some embodiments, the folds include wrinkles such that the material of the pouch can be pressed together from both ply to form a seal area. In some embodiments, the pleats include pleats in the pouch material that have sufficient depth and / or durability to remain clean when the pouch is unfolded. In some embodiments, the corrugated fold line includes a natural line where the pouch is folded back and / or folded back from the empty deployment position. In some embodiments, the corrugated folds may be formed within a short distance of the wrinkle, for example, within 0.5 mm to 1 mm, 1 mm to 2 mm, 2 mm to 4 mm, 3 mm to 6 mm, Or within a further range of distances with shorter boundaries, overlying the ply of pouch material.

In some embodiments, the predefined package is compact and may be smaller, for example 75%, 50%, 25%, or smaller than the volume of pouch material packaged, smaller, . In some embodiments, the compactness can be reduced to less than 95% of the loosened volume, or less than 80% of the loosened volume, while being compactly folded in comparison to the loosened volume, , Or an intermediate compact rate. The pouch package is compact in some embodiments if it is placed within a greater thickness than the required envelope thickness of less than 50%, or 25%, less than 75%, or other larger, smaller or intermediate package thickness. In a preferred embodiment, a double layer of 60 micron pouch film is used to make the pouch, and the pouch itself is folded into a 3x6 pattern of the longitudinal panels. The total thickness of the fold is thus about 2169 microns (2.16 mm), and 150% of this thickness is about 3.24 mm. Considering compactness from another point of view, the preferred package is fully compressed to a thickness of 2 mm, but if released again, it is springed twice this thickness (e.g., the natural spring nature of the material, Or for other reasons). In some embodiments, when the package is reduced to a thickness of 3 mm, a compressibility of 75% is achieved.

In some embodiments, the relatively largest single lateral area of the packaged pouch may have a relative surface that is <5%, <10%, <25%, <50%, <75%, <100% (Unfolded or unfolded) single side area of the pouch and / or a portion of the unfolded surface area of an intermediate, smaller, or larger pouch.

In some embodiments of the present invention, one or more pleats between the panels serve to limit the passage of liquid and / or solid waste. In some embodiments, the passage is limited by squeezing the fold across the pleats. In some embodiments, the resistance to passage through the fold is maintained by the restriction of the inflation space by the pouch safety device.

Limiting the access of solids and / or liquid waste to the filter, that is, reducing the occurrence and / or the rate of clogging of the filter has a potential advantage. In some embodiments, the filter is coated with a membrane that is gas permeable but liquid and solid impermeable, potentially reducing production complexity and cost. In some embodiments of the invention, the fart passes over one or more pleats to reach the filter. In some embodiments, the filter is positioned within the designated panel of the folded open pouch. In some embodiments, the designated panel is located in a panel separated by a single pleat from the entrance aperture of the pore fence. In some embodiments, the design panel is folded over the inlet aperture portion such that the waste is directed upwards for at least a portion of its journey to reach the filter, for example upwards to reach the wrinkle, then downwards, and / It must flow downward to reach the wrinkle and then upwards. In some embodiments of the invention, by separating the filter from the inlet of the pouch excreta by one, two, or more pleats, the rate at which the liquid and / or solid excreta reaches the filter is slowed compared to the rate at which the gas travels.

In some embodiments, the relative resistance to liquid contrary to the flow of gas across the corrugations includes stress strain based on the relative viscosity and / or surface tension of the two material types. In some embodiments, the impact gravity reduces the flow of liquid through the fold portion while the flow of gas is relatively unaffected. In some embodiments of the present invention, greater mobility of the gas under pressure enables the gas to reach and fill the void space before the liquid. Potentially, this reduces the pressure differential driving the movement of the material. In some embodiments, the wrinkle portion includes a narrow path that resists the flow of liquid along its length more than the flow of gas, due to, for example, the surface properties of the pouch (such as hydrophobic) interacting with liquid and gas differently do.

In some embodiments, the designation panel is selected to reach the desired approach passage of farts from within the folded pouch to the filter element, for example across one pleat, two pleats, three pleats or more. Optionally, the choice of passage length is based on the desired relative resistance to the fart passages and / or the solid / liquid waste passages. In some embodiments, the designation panel is selected based on the location of the discharge apertures of the internal filter of the collapsed pore excrement pouch package. For example, the vent opening may have a direct approach to the open side of the fold and then externally, and / or a method of approaching the exterior after passing around at least one fold portion of the pouch package, Respectively. Even if the pouch partially expands, it is advantageous to arrange the filter and remain unobstructed during wear of the draw-through aperture. In some embodiments, the portion containing the pore excrement collection pouch includes one or more outlets that prevent closure of the filter by accumulation of back pressure in the outside air. For example, a pouch safety element (such as a cover for an open mouth cap) includes an incomplete attachment to one or more apertures and / or one or more open apertures and / or permits passage of gas. In some embodiments, the approach path of the fart to the filter element is set so that the gas flow through the filter can be, for example, 1-10 ml / min, 2-5 ml / min, 3-8 ml / min, Low, medium, large, and / or smaller boundaries. The low gas removal rate provides a potential benefit by enabling more effective filtering. More effective filtering potentially reduces the fecal odor and / or makes it possible to use less filter material to achieve a given filtering condition.

In some embodiments of the invention, the filter is located at a designated position and / or orientation within the panel. For example, when the pouch is in a folded configuration, it is positioned in the area of the panel that occupies a high position. Placing in a high position provides a potential advantage of reducing the chance of contact with solids and / or liquid dirt. In some embodiments of the invention, the filter is sufficiently far away from the wrinkle to be substantially free of interference with the fold, e.g., 1 mm to 2 mm apart, 2 mm to 4 mm apart, 3 mm to 8 mm apart, 5 mm to 10 mm, And are disposed at other distant distances. In some embodiments of the invention, the filter is sized to avoid wrinkles, for example, 1 mm to 2 mm apart, 2 mm to 4 mm apart, 3 mm to 8 mm apart, 5 mm to 10 mm Away, or other distance away. In some embodiments, the filter element is disposed to cross the corrugated area. In some embodiments, the volume of the filter element of the corrugation area is reduced, for example, by removing a large amount of material from the corrugation and / or by notching and / or cutting.

This has the potential advantage of preventing pinching of the filter so that the exit aperture is sealed and gas from the stoma is prevented from escaping from the exit aperture. In some embodiments of the present invention, the filter seals the sides that can make the most contact with the dirt, for example, the side facing the direction in which the dirt reaches the filter and / or the vicinity of the opposite side. This is a potential advantage of avoiding filter contamination by dirt. Another potential advantage of side-sealing is that the exit hole of the filter is closer to one (sealed) edge of the filter without shortening the minimum path from the filter inlet surface to the filter outlet. Potentially, this allows a longer path, which increases the filtering efficiency. Additionally or alternatively, this allows a potentially low filter material to be used. The use of less filter material potentially reduces material cost, and / or reduces the bulk of the folded pouch package.

In some embodiments of the present invention, the overall configuration of the filter, pouch, pouch suppression portion, and / or other open mechanism components is dependent on the filter flow rate, and / or the pressure initiated by the flow through the filter (effective crack pressure) Respectively. In some embodiments, the minimum outlet pressure is set to, for example, 1 to 10 mmHg. In some embodiments, the minimum outflow pressure may be, for example, 1 to 5 mmHg, 3 to 7 mmHg, 5 to 10 mmHg, 8 to 15 mmHg, 12 to 20 mmHg, 10 to 50 mmHg, 45 to 120 mmHg, or Are different ranges of pressure having the same, medium, higher, and / or lower bound. In some embodiments of the present invention, the outlet pressure can be controlled, for example, by one or more of the characteristics of the filter itself, i.e. the phase position of the sub-panel of the pouch to which the filter is attached (e.g., (E.g., near the edge or embedded part of the fold), and / or a position on the sub-panel occupied by the filter element (e. G. By the leakage sensitivity of the compartment accommodating the pouch.

The low efficiency cracking pressures and / or high flow rates can be used, for example, to reduce physiological blotting and / or to improve the durability of sealing of an open oral contamination system (e.g., sealing of the wafer to the skin) . The higher effective cracking pressure and / or lower flow rate provides a potential advantage by allowing gas to partially press the pouch panel segments past the inlet panel, thereby resisting pressurized filling of the fluid or solid. Potentially, the effective filter life increases through it. In some embodiments, a low flow rate still provides sufficiently efficient odor control while allowing the use of a less efficient filter (potentially less costly) for odor collection. In some embodiments of the invention, the flow rate through the filter can be controlled by a component other than the filter itself, such as the corrugated fold of the pouch, the size and / or shape of the outlet (vent) aperture of the filter, and / (E.g., by the pouch restraining portion) of the pawl.

The effective cracking pressure and / or flow rate may, in some embodiments, be dependent on the pattern of folding of the pouch (e.g.), the forced contaminants placed on the pouch by the pouch restraining portion, and / or the design of the filter element itself and / It is adjusted by position designation.

BRIEF DESCRIPTION OF THE DRAWINGS Before describing at least one embodiment of the present invention in detail, it is to be understood that the invention is not limited to the details of the arrangements and arrangements of the components and / or methods described in the following description and / But need not be limited. The present invention may be practiced or carried out in various ways.

Planar  An exemplary opening mechanism with a filter

Reference is now made to FIGS. 1A through 1C and FIG. Figure 2 illustrates a gas filter 160 in the side wall of an open mouth mechanism 200 in accordance with some exemplary embodiments of the present invention. The support region 190 is part of the open housing 123. Support region 170 is optionally a portion of collapsed pore excrement collection pouch 150.

In some embodiments, the filter 160 and the support regions 170, 190 are held together to form a filtrate discharge for gas exiting the pores. Optionally, the gas is filtered during passage through the filter 160. In some embodiments, the filter body 160 also includes a barrier to the outlet of the solid and / or liquid pore excrement.

The sidewall hermetic filter may be provided with a potential for opening the mouthpiece by allowing the filter body to be enclosed and / or protected by mechanical components involved in the functions of mechanical support, damping suppression, and / . The purpose of this combination is to potentially reduce manufacturing costs associated with having filtering capabilities. The sidewall location also provides potential advantages by separating the gas release from the solid / liquid fecal release. In some embodiments, the passageway for emptying solid / liquid or gaseous effluent is separately operable. In some embodiments, the physical separation of these functions makes it possible to further characterize the structure to meet different requirements for release timing and control.

1A-1C illustrate an open mouth mechanism 100 with separate gas and solid / liquid body exudate channels, in accordance with some embodiments of the present invention. The open mouth mechanism 100 includes a filter element 160 that is retained on the side wall of the adapter housing 135 that can be detached from the open mouth housing 120. FIG. 1C shows an enlarged view of the exemplary gas filter 160, the filter support region 180, and the cap housing 135 of FIG. 1A. Figs. 1A and 1B show an overview (an exploded perspective view and a cross-sectional view, respectively) of an open mouth mechanism 100. Fig.

In overview, in some embodiments of the present invention, the open mouth mechanism 100 comprises a pile of open mouth parts. The most distal part worn on the skin of the user (not shown) is an open mouth housing 120. An exemplary opening cuff 130 is attached to the open dome housing 120, for example, via a flange 125. In some embodiments, the sealing element 115 is squeezed between the opening cap 130 and the opening housing 120. In some embodiments, the cap 130 includes at least one of a housing 135, a lid 140, a folded pore excrement collection pouch 150, and / or a gas filter 160. The wafer 120, the sealing element 115, and the cap housing 135 have through-holes, and the pore exudate reaches the folded pouch 150 through the through-hole. The pouch 150 may be inflated to release waste for disposal. Other configurations of dummy parts of the pore are found, for example, in Applicant's U.S. Patent Application No. 61 / 645,118.

In some embodiments, the gas flow through the filter 160 slows or prevents internal pressure from becoming inconvenient and / or augmented to a dangerous level. For example, pressure buildup over 50 mmHg, 80 mmHg, 100 mmHg, 120 mmHg, 150 mmHg, or 200 mmHg is prevented. If possible, the lowered internal pressure increases the sealing life of the mouthpiece, e.g., the sealing life between the mouthpiece and the skin.

Some potential advantages of sidewall-mounted filters are related to restoring excretion-suppression function to the peri-implant patient.

Some of the benefits of excretion suppression recovery occur potentially in combination with the configuration of the folded pouch 150. The folded, optionally collapsed, pouch 150 potentially interferes with gas emissions through the filter located in the cover 140 or incorporated into the pouch 150 itself. The sidewall position can potentially avoid interference and the filter will continue to operate to release the gas while the deployment of the pouch can be delayed until it is necessary to evacuate the excreta. In some embodiments of the present invention, the separation between the gas and the solid / liquid feces occurs within the region defined by the circumference 136. Thus, separation may occur before the excrement reaches the slurry waste pouch, where the gas escapes laterally through the through-holes formed in the sidewalls. Optionally, the liquid and feces continue to pass through the lumen 138 at the proximal end and eventually into the pouch for disposal.

In one potential advantage for excretion restoration recovery, the continuously evacuating filter can prolong the period of wear without the need for pouch deployment to accommodate gas buildup. In some embodiments, an embodiment of fecal incontinence restraint is restored to a patient with a superficial installation by restraining the folded pouch 150 in an excretion suppression mode during normal wear. In the excretion suppression mode, the solid and liquid excreta are refrained until the pouch deployment for excretion release. The scent provided by the excretion suppression mode is potentially complete or nearly complete, and therefore the feces can not be noticed (secreted) by others in the social environment.

The secrecy of bowel movements potentially increases the freedom of activity for patients with superficial instillation by reducing the need to conceal and / or protect the external excrement storage pouches. The secrecy of the bowel movement is also potentially beneficial also by the filtered gas release which reduces the emitted odor. Also contributing to the secrecy of the bowels is to avoid pouches that potentially accumulate the amount of gas in the stomach. The gas filled pouch may be potentially visible to others and / or uncomfortable to wear and not completely contract when the gas in the stomach is stopped, because the filter ceases to act as soon as the pressure equilibrium is established. If the bag is depressed during discharge or wear, the resulting reservoir potentially increases stool odor. In contrast, the filters used with folding bags act potentially more efficiently to prevent undesirable gas storage.

Timely release as needed is another aspect of restraining excretion. In particular, it is a potential advantage to avoid venting if the pressure causing the discomfort and / or feeling of fullness in the intestines is mainly due to gas. Potentially, by sensing the difference used to determine the time of discharge, more time is provided to allow the liquid in the feces to be reabsorbed by the body prior to feces discharge. Potentially, early and / or unnecessary emissions are reduced, thereby reducing the cost of replacing expendable supplies. Other potential benefits include increased convenience due to potentially increased duration between emissions and / or discharge control for excretory drainage patients.

Another aspect of restored fecal excretion is to provide pressure safety. In some embodiments of the present invention, the pouch 150 is deployed to automatically fill liquid and / or solid excreta upon critical pressure generation. Optionally, this threshold is set to provide safe release. In some embodiments, for example, the lid 140 is automatically released when the critical pressure is reached, allowing deployment of the pouch 150. Alternatively, the deployment may be accomplished manually by, for example, removing the lid 140 when the patient is perceived to be under pressure to potentially indicate that draining is required. Perception of pressure by a patient with a superficial installation may be a feeling of fullness. Optionally, sensing includes pressure indications by the opening stack itself, for example, buckling, stiffness of the pressurized surface, and / or warning.

Regarding safety release pressures, reducing or preventing pressure build-up due to intestinal gas is again a potential benefit. Potentially, the path for the continuous discharge of gas prevents the critical pressure for automatic deployment from being exceeded by the pressure caused by the gas. Potentially, the continuous release of gas increases the certainty that the sensed pressure is (or does not result from) the excretion that requires pouch discharge. Potentially, certainty is increased by keeping the gas pressure normally low and / or by providing an indication that the gas pressure is releasably controllable.

In some embodiments, the body 169 of the filter 160 is of a known construction, for example, of felt, cloth, foam, grid, or cake. In some embodiments, the body 169 of the gas filter 160 includes an odor absorbing material that filters odorant in the outgoing gas. Potentially, the filtered odorant is a hazardous odorant, for example a stool odor. According to this embodiment, odor absorption is by using, for example, activated carbon, silica gel, zeolite and / or carbide-derived carbon. In some embodiments, the filter is preloaded with a flavor and / or odor neutralizing material that absorbs gases that are less harmful to the gas passing through the filter. Potentially, the filtration slows the gas release, so that the external concentration of the odorant is less noticeable to the superficial installation patient and / or others.

In some embodiments, the elements of the mouthpiece retain the filter element and / or protect against contamination and provide another functional role. Filter maintenance / protection includes, for example, maintaining the filter element in place, sealing against the filter element, and / or filtering the inlet of the filter element. Suitable mouthpieces for the filter element housing include pouches, caps, wafers, and / or an open mouth appliance adapter.

In some embodiments of the present invention, the filter retention aperture includes at least a base element and a cover element directly connected to each other. For example, a gas filter 160 is received between filter support areas 170 and 180. In some embodiments, the filter element includes a communication path that allows gas to pass between the lumen of the housing and the exterior of the housing. The housing of the filter essentially constrains the existing internal gas so that it can escape through the body 169. The flow is resisted outside the sides 163, 166 along the surfaces of the surrounding surfaces 180, 170, 181, 182 and / or the surrounding filter body 169. FIG. 3A also shows a pair of housings and filter body surfaces 381, 363 and 382, 364 with the gas flow being resisted therebetween. The flow resistance is increased, for example, by sealing the pressure and / or by a sealing coating on the surface of the filter body 360.

In some embodiments, the base element is a housing 135 of a part of an open mouth mechanism, e.g., a cap, adapter, wafer, sealing element, or disk. In some embodiments, the housing comprises a rigid or semi-rigid material, such as polyethylene or polypropylene. In some embodiments, the housing comprises a flexible material, such as polyurethane rubber, silicone rubber, or thermoplastic elastomer (TPE).

In some embodiments, the base and / or lid elements are part of the pore excretion collection pouch 150. The pouch portion is, for example, a flange comprising a pouch mounting element, or a film comprising a receiving portion of the pouch. In some embodiments, the lid component is a housing of a component of an open mouth mechanism, such as a lid, cap, adapter, sealing element, or disc. In some embodiments, the lid element has a lumen, a common exterior to the lumen, and an exterior of the base element. In some embodiments, the lid element is free of lumen and / or there is no lumen common to the filter support base element. [0322] Optionally the lid component comprises a membrane.

In some embodiments, the slots for the filter 160 are sized to be sealable by press fit on at least one side of the filter 160. In some embodiments, bonding and / or bonding causes flow resistance between the filter element surfaces 163, 166, 169 and the filter support surfaces 170, 180, 181, 182. In some embodiments, an adhesive is applied between the filter element 160 and the support areas 170, 180 of the aperture. Optionally, the adhesive is applied as a liquid, paste, slurry, or polymer clay to fill the gap between the filter and the through-hole. According to the present embodiment, the adhesive is applied before or after inserting the filter element 160 into the through-hole.

In some embodiments of the present invention, the material of the filter body 169 is in direct contact with the filter support areas 170,180. In some embodiments, the filter body 169 is layered on one or more surfaces (e.g., surfaces 163, 166, 363, and 364) by a filter sealing layer 168.

In some embodiments, the filter sealing layer 168 covers the entire surface of the filter body 169. In some embodiments, the filter sealing layer 168 covers a portion of the surface of the filter body 169.

According to this embodiment, the unconstrained thickness of the filter element 160 is, for example, between 0.25 mm and 0.4 mm, between 0.3 mm and 0.5 mm, between 0.7 mm and 1 mm, between 1.4 mm and 3 mm, between 2 mm and 4 mm Any thickness, or another thickness that is greater than or less than. In some embodiments, the filter element 160 is compressed to a thickness of, for example, 30% to 40%, 40% to 60%, 50% to 80%, 95% to 100%, or less of the unconstrained thickness. The smallest (non-thick) dimension of the filter element 160 spans, for example, 3 mm to 4 mm, or 5 mm to 8 mm, 8 mm to 12 mm, 15 mm to 20 mm, greater than or less than this. The largest broad dimension of the filter element 160 extends for example from 3 mm to 4 mm or from 5 mm to 8 mm, from 8 mm to 12 mm, from 15 mm to 20 mm, from 20 mm to 30 mm, greater than or less than this. In some embodiments of the present invention, the filter element 160 may, for example, (but not necessarily) include a filter element that is substantially It is flat. In some embodiments, the ratio of the filter thickness to the other two dimensions of the filter element is, for example, at least 5: 1, at least 10: 1, at least 20: 1, or greater. In some embodiments, at least the widest surface of the filter is sufficiently flat to accommodate a laminate such as the filter sealing layer 168.

The gas throughput of the filter element 160 can be, for example, from 1 to 2 ml / min, from 2 to 5 ml / min, from 7 to 13 ml / min, from 20 to 30 ml / min, from 40 to 80 ml / min, 150 to 200 ml / min, higher or lower. For reference, the given throughput value is the value when the differential pressure between the inlet surface and the outlet surface is 100 mmHg.

Filter injection Strainer  And valve Example

3A-3C. These figures show an example of a strainer that prevents clogging of the filter 360 according to some exemplary embodiments of the present invention. In some embodiments, the strainer also inhibits blocking of its own channel, which may hinder the gas leak function.

In some embodiments of the present invention, the strainer separates the barrier wastes from the filter injection structures. There is a potential advantage of reducing the contact of the injection surface 361 of the filter element 360 with the non-gaseous material which may damage the filter element. Damage may include, for example, increased resistance, reduced odor adsorption, and / or reduced permeability of the filter.

FIG. 3B shows a sensing structure, including the housing 335 of FIG. 3A, with a membrane material 348 attached thereto, in accordance with some exemplary embodiments of the present invention. In some embodiments, conduit channel 341, inlet 346, and inlet aperture 347 include gas-conducting connections separating injection surface 361 and lumen 323.

In some embodiments, the inlet 346 and / or the conduit channel 341 include recesses in the housing 335. In some embodiments, the one or more islands 343 serve to form channels 341 and / or one or more inlets 346. In some embodiments, the channel 341 is extended by placing the filter 360 toward the outer rim of the open mouth device while leaving the channel space further inward. Optionally, the membrane material 348 is the material of the open mouth drain pouch, e.g., the pouch 150.

Figure 3C schematically depicts a rigid open spiral stack element secured together to form a sliding structure, in accordance with some exemplary embodiments of the present invention. The housing 335 is closed against the closure structure 349 to form a channel 341 and an inlet 346. Optionally, the closure structure 349 is a rigid body that attaches and / or elastically seals the housing 335. Optionally, the housing 349 is a housing of an open dental appliance, such as an adapter, a wafer, or a sealing element.

In some embodiments, the exhaust of the pore gas is guided from the inlet aperture 347 through the inlet 346 to the channel 341 and then to the injection surface 361. From the injection surface 361, they are filtered through the body of the filter 360 and then discharged from the filter discharge surface 362.

The long, narrow gas passageway in front of the injection surface 361 provides a potential advantage of preventing damage by leakage through the inlet apertures 347 by increasing the travel path. Potentially, the infiltrating material is self-limiting due to the small channel size to form a plug that prevents deeper contamination of the channel.

In some embodiments, a plurality of inlets 346 are provided. This potentially increases the resistance to loss of the gas leakage function, for example when one or more inlets become dirty during use. In some embodiments of the present invention, the conduit channel 341 extends circumferentially around the housing lumen 323. In some embodiments, the channel 341 extends around the entire circumference. In some embodiments, the channel 341 extends around a portion of the circumference. In some embodiments of the present invention, there are a plurality of inlets 346 arranged at intervals (regular or irregular) around the perforated circumference. Depending on the embodiment, there are, for example, 16, 12, 10, 8, 6, 4, or 2 inlets 346. In some embodiments, there is one inlet 346. Optionally, the inlet extends so as to potentially blockage at a limited extent of the inlet without blocking the inlet as a whole.

In some embodiments, the inlet apertures are configured to inhibit self-blocking. The swinging includes directing the gas to the filter element 360 while simultaneously separating the gas from the solid and / or liquid waste within the lumen 323. In some embodiments, the separation includes excluding the size such that the dimensions of the apertures 347 are sufficiently small to exclude solid waste particles larger than a predetermined size. In some embodiments, the apertures 347 are small enough to prevent internal fluid pressure (e.g., due to surface tension) from passing the fluid through the apertures.

In some embodiments, the length of the inlet apertures 347 is, for example, 0.08 to 0.12 mm, 0.2 to 0.5 mm, 0.8 to 1.5 mm, 1.4 to 3 mm, 2.5 to 7.5 mm, 7 to 13 mm, May be larger or smaller and may be between them. In some embodiments, the depth of the recesses forming part of the apertures 347 may be, for example, from 5 to 10 mils, from 10 to 50 mils, from 0.05 to 0.1 mm, from 0.2 to 0.3 mm, from 0.4 to 0.7 mm, from 1 to 2 mm, 2 to 3 mm, larger or smaller, and may be a depth between them.

In some embodiments of the present invention, the surface of the material forming the inlet apertures 347 is hydrophobic. Potentially, this ensures that the filter element injection surface is not wetted. In some embodiments, the surface is treated to increase hydrophobicity. For example, the surface may be coated with wax or other hydrophobic material or treated to roughen the surface structure. The inlet aperture 347 hydrophobicity corresponds to a contact angle in excess of or greater than the contact angle of, for example, 91-100 °, 95-100 °, 100-120 °, 110-140 °.

It would be advantageous to have a replacement passageway for the gas flow when the through-hole 347 blocked in use is greater than one. Illustrating use during the day, the ostomate wears the housing 335 in a vertical position and directs the filter element 360 upward. The waste reaching the lumen 323 is potentially pulled down by gravity. In this position, the lower apertures 347 are potentially blocked, while the upper apertures (adjacent to the filter element) remain open in the passage of gas. In the case of using at night, the patient with a superficial installation is placed on one side so that the injection hole is placed on one side of the filter block in front of the holes on the other side.

When the infusion apertures are sufficiently elastic to be closed under pressure, they can be closed back against the inflow of blocking wastes. For example, pressure due to solids and / or liquid waste urged on the inlet apertures 347 can potentially close the apertures before leaking into the apertures. Unobstructed openings are potentially open to gas exchange. When the waste moves away from the pressure-relief channel, for example, when the superficial installation patient position is changed, the channel returns to its original position and functions. The increase in gas pressure is more easily balanced on both sides of the through-hole so that the channel is potentially closed thereby.

The advantage of having multiple injection holes is that the injection surface area increases accordingly. In a plurality of through holes, each channel can be made small and at the same time, the total surface area of all holes is increased depending on the number of channels. Also, to illustrate what is used at night, the superficial installation patient is placed behind the patient at an angle such that the housing is practically horizontal. In some embodiments of the present invention, the injection apertures are provided in a number sufficient to overcome a predetermined average level of blockage. For example, ten apertures are provided, where a 90% average block of all apertures is sufficient to provide sufficient gas leakage.

In some exemplary embodiments of the invention, the membrane material 348 is attached to the surface of the housing 335 by welding and / or gluing. Attachment is effected, for example, by adhesive, chemical treatment and / or heat treatment. In some embodiments, the membrane material 348 is attached to at least one inlet- and conduit-channel wall structure 343. In some embodiments, the membrane material is attached to the flange 367. In some embodiments, the membrane material prevents the introduction of lumens 323 into the lumen of the injection strainer, except for the injection apertures 347. [ An infusion opening 347 is formed between the floor of the loop of the membrane 348 and the groove of the inlet 346 and the wall.

In some embodiments, the membrane material 348 is a film known in the art of making an open pouch. Optionally, the film is made of a single material, for example polyethylene, ethylene, ethylene vinyl acetate, polyamide or cellulose. Optionally, the film is made of a number of materials by a co-extrusion process, such as mixing more than one of the film materials. In some embodiments, the membrane material is a foil, such as aluminum. In some embodiments, the membrane material 348 is a porous structure, such as, for example, a fabric or felt sealed with a plastic coating. In some embodiments, the membrane material 348 is a layer of a flexible material, such as silicon, polyester, or polyethylene terephthalate. Optionally, the material is used in wet form by techniques including spraying, brushing, and then dried. In some embodiments, the thickness of the membrane material 348 is, for example, between 0.01 and 0.025 mm, between 0.045 and 0.055 mm, between 0.09 and 0.11 mm, between 0.18 and 0.22 mm, between 0.25 and 0.35 mm, Or thin.

Depending on the embodiment, the diameter of the lumens 323 of the housing 335 may be 12 to 17 mm, 15 to 25 mm, 25 to 35 mm, 32 to 45 mm, 40 to 55 mm, or larger or smaller. The distance between the inner and outer diameters of the flange 367 may be, for example, 1 to 3 mm, 3 to 7 mm, 6 to 15 mm, 14 to 28 mm, or longer or shorter. Depending on the embodiment, the total length of the lumens 323 may be from 0.8 to 1 mm, from 1 to 2 mm, from 2 to 7 mm, from 5 to 15 mm, from 15 to 25 mm, or longer or shorter.

FIG. 4A illustrates a procedure for fabricating pockets 480 for filter 460 in accordance with some exemplary embodiments of the present invention. The cap sub-assembly 400 includes a pouch film 450 and a cap housing 435. These represent a portion of the weld mechanism 410 used to fabricate the cap sub-assembly 400.

In some embodiments of the present invention, the support structure for the filter 460 is constructed by selective bonding of the surface. In some embodiments, the at least one lumen is formed, for example, by selectively bonding adjacent surfaces at two or more sides of the non-adhesive region.

FIG. 4A shows a pouch film 450 located above open mouth part housing 435. FIG. In some embodiments, the film 450 and the housing 435 are bonded together to form a pocket 480 for holding the filter element 460. In some embodiments, bonding is performed using the weld mechanism portion 410. The weld mechanism portion 410 fixes a press (not shown) and utilizes heat, pressure, RF (radio frequency) irradiation, and / or mechanical vibration to fuse the open components.

In some embodiments of the present invention, the welding tool 410 includes a ring having a gap 415. The bonding during manufacture includes compressing the device 410 against the pouch film 450 and the housing 435. [ However, the bonding does not take place in the region 480 below the gap 415 where no crimping takes place. In some embodiments of the invention, this forms a pocket region 480 between the pouch film 450 and the open configuration housing 435. In some embodiments, the pocket region maintains the filter element 460 in place. In some embodiments, a portion of the pocket region acts as an injection tracing structure.

Figures 4B-4D illustrate the use of an alternate device portion 410 having a groove 416 in place of the gap 415. The device portion 410 is reversed in Fig. 4B relative to Fig. 4A.

In some embodiments, the groove 416 reduces or removes the pressure device portion 410 that affects below the groove. 4C, the device portion 410 is positioned over the film 450, the filter element 460, and the housing 435 for welding. In Figure 4D, the machine parts are compressed above these elements for welding assembly.

In some embodiments of the present invention, the grooves 416 are sized to substantially match the filter element 460 while compressing the distance 462. The distance 462 is, for example, 5% to 20%, or 15% to 30% of the uncompressed filter size. In some embodiments, partial compression also applies sufficient pressure to the filter element 460 to seal the film 450. In some embodiments, compression of the filter body 460 during manufacture facilitates sealing along the sides of the filter elements due to the resilient force.

Depending on the embodiment, the filter 460 is installed before or after bonding. In some embodiments, the filter 460 is located in the region 480 before the junction holds the filter. Alternatively, the filter 460 is inserted into the pocket area after the pocket area is formed. For example, the filter is compressed by the insertion device, then inserted, and then the insertion device is removed. In some embodiments, the filter 460 is retained within the pocket region 480 by contact compression with the pouch film 450 and / or the open mouthpiece 435. In some embodiments, the pocket region 480 maintains the filter element 460, thus being placed in a path having a minimum resistance for discharging the gas. In some embodiments, the volume of the pocket 480 includes a pressure relief in the component housing 435, such as in the support region 180 of FIG. 1C.

A possible advantage of keeping the filter 460 in place by compression and / or friction rather than direct bonding is that the filter 460 can be removed and / or replaced without disabling the mouthpiece to retain the filter It is. A possible advantage of a removable filter element is that the filter can be replaced. Optionally, the outer perforations of the pocket region 480 are wider than the filter (facilitating filter entry) and internally narrowed to seal against the filter body. Potentially, the filter replacement makes it possible to use the dental appliance for a longer period of time after contamination of the first filter element which interferes with effective gas release and / or filtering. Additionally or alternatively, the user may decide to permanently or temporarily remove or release the seal around the blocked filter to restore passive gas release.

Another possible advantage of compressing and holding the filter 460 is that it eliminates the need for some joining operations required to manufacture the pouches, filters, and housing sub-assemblies. Optionally, the body material of the filter element 460 is not bonded to the backing layer, but is otherwise used to contain the gas passing through the filter body. Possibly, simplifying the filter element 460 saves manufacturing costs.

The shape of the lumen constituted by selective surface bonding is not limited to monolithic, straight or unbranched lumens. For example, the channel structure of Figures 3A-3C can be configured without a groove in the housing 335 by selectively bonding the membrane material 348 selectively to form a gas passage. In some embodiments, this selective bonding is controlled by properly arranging the gaps in the grooves and / or bonding mechanism portion 410.

FIG. 4E shows gases 401, 402, 403 exiting through the pressure-actuated valve, in accordance with some exemplary embodiments of the present invention. The cap sub-assembly 400 includes a pouch film 450 and a filter 460 bonded to a cap housing 435 in an area 451. The sub-assembly 400 is fabricated, for example, as described in connection with FIG. 4A. For clarity, the folded pouch film 450 is partially or completely transparent away from the dashed boundary.

In some exemplary embodiments, region 474 includes a pressure-actuated valve formed by an array of pouch films 450 selectively bonded to housing 435. The pressure from the mouthpiece (indicated by arrow 401) preferably pushes upwards against the surface of the waste collection pouch film 450. Under sufficient pressure, the pouch material in the region 474 near the injection surface of the filter 460 is raised away from the housing 435. By the lifting, the pore discharge gas 402 is formed with a through hole that can pass through the outer side 403 of the through-hole mechanism. In some embodiments, the pouch film 450 is tightly pulled across the region 474, so that the through-bore is closed without open pressure. In region 474, pressure-dependent opening and closing causes it to act as a flutter valve.

Figures 4F-4G detail the operation of the flutter valve of Figure 4B in accordance with some embodiments of the present invention. The flutter valve includes a pouch 450 and a cap housing 435 in a region 474 near the injection surface of the filter 460. Possibly, the flutter valve helps prevent or mitigate contamination of the injection surface of the filter element 460.

In some embodiments, the filter element 460 does not extend completely across the rim of the housing 435 in the region 480. In some embodiments, In some embodiments, an infusion strainer is formed in region 474, wherein the material of pouch 450 and housing 435 is not bonded.

In some embodiments (Figs. 4E-4F), sufficient pressure within the pores pushes away a portion of the pouch 450 from the surface of the housing 435. This forms a through hole 478 through which the gas can reach the filter element 460. When the gas is released, the pressure is reduced. In some embodiments, the material of the pouch 450 including the flutter valve is returned to a position opposite the surface of the housing 435 (Fig. 4G). Optionally, the material of the pouch 450 is sufficiently taut and resilient to completely close the through-hole 478. [ Alternatively, the through-holes 478 are loosely closed, but sufficiently reduce the through-hole size to inhibit the passage of fluid and solid waste.

A possible advantage of such a flutter valve mechanism is to separate the filter element 460 from possible contamination by the waste, except during periods when the released pore gas is present immediately. Optionally, when the solid and / or liquid waste reaches a predetermined pressure required to open the through-hole 478, the vacuum that can not be discharged in any case indicates the presence of a significant amount of waste There is a need. In some embodiments, the filter is discarded after the vacuum has taken place, so that short-term outgassing can be tolerated.

In some exemplary embodiments, the flutter valve is positioned to differentiate between pressure from the gas or pressure from the liquid / solid waste, for example, as follows. In some embodiments, a flutter valve that opens and closes in response to ambient pressure is installed into the injection strainer as shown in Figures 3A-C. Optionally, the flutter valve is normally open and closed under external pressure. Due to the elevated gas pressure in the pore device, the valve remains open as the pressure rapidly equilibrates at both sides of the flutter valve. However, in the presence of elevated pressure due to liquids or solids, injection scanning slows down or prevents pressure equilibrium. If the pressure differential over the flutter valve is large enough (due to waste pushed from the outside), the through-hole of the flutter valve is closed. Possibly, this prevents contamination of the injection hole from itself. If the pressure is subsequently released (for example, if the intestinal tract patient is relocated), the uncontaminated infusion can again pass the gas.

The shape of the design of the filter element

5A to 5C, and show filters 561, 562, 563 of the type for different filtering requirements according to some exemplary embodiments of the present invention.

In some embodiments of the invention, the shape of the filter element is selected to increase the adsorption area of the filter element. Additionally or alternatively, the shape is selected to create room for additional surface attachment so that the strength of the lumen wall is not compromised.

FIG. 5A shows an exemplary filter element 561 located on or within a recess or pocket region of the exemplary opening component housing 536. FIG. The filtering length extends between the inlet surface 561A and the outlet surface 561B in contact with the lumen 523 of the housing 536. [ In some embodiments of the present invention, the filter element 561 is limited to contain only a portion of the open mouth part circumference. The circumferential portion may be, for example, 90 °, 60 °, 45 °, 20 °, 10 °, any portion between them, or a larger or smaller portion of the circumference of the wall.

A possible advantage of embracing a limited part of the circumference of the wall is that the rest of the wall can be connected to the surface of another opening part, for example a waste collection pouch. More surface area can be connected, and the strength of the overall opening device can be increased. Another possible advantage is that it uses a reduced filter material, thus only containing a limited portion of the circumference of the wall. The non-annular filter geometry also makes it possible to use a more effective filter geometry when cut from a sheet of filter material, reducing losses.

FIG. 5B shows an exemplary filter element 562 located on or within the recess or pocket region of the exemplary open mouth part housing 537. FIG. In some embodiments, the filter material is cut from the area 531 in the arc enclosed by the filter element 562 in the housing wall. In some embodiments, the area 531 may be attached to, for example, an oral waste collection pouch. The region 531 may be located on, for example, an outer wall or an inner wall of the housing 537, or may be included within the contour of the aperture of the filter 562. The region 531 can be of any shape, for example, round, square, rectangular or triangular. In some embodiments, the housing 537 includes a groove that is shaped to compensate for the filter element 562, and a filter element 562 is coupled within the housing. In some embodiments, the housing 537 is flat, and attachment to the pouch, for example, includes compressing the membrane past the filter, so that it contacts the area 531.

A possible advantage of the area without the filter material in the body of the filter is that there is another point of attachment between the housing 537 and the open mouthpiece such as the pouch to which it is attached. Preferably, the additional attachment point increases the circumferential extent of the filter element 662 without compromising strength.

FIG. 5C illustrates a filter element 563 located on or within the recess or pocket region of the exemplary opening component housing 538. FIG. In some embodiments of the present invention, the filter element 563 has a portion 533 that extends into the lumen of the housing 538. In some embodiments of the invention, the elongated portion 533 is shaped to increase the available edge surface area. In some embodiments, the surface area exposed by the elongated portion is increased by lengthening the shape thereof, for example, by making the shape thereof into a waveform or jagged shape. In some embodiments, the surface area is increased by creating a slit in the body of the filter. Preferably, the narrow slits serve as a tracing function to inhibit the ingress of solid or liquid waste. In some embodiments, the elongated portion 533 remains uncoated on its surface, so that the body of the filter is exposed.

A possible advantage as the exposed surface area of the filter 563 increases is that it alleviates the contamination of the filter injection surface. For example, a tenfold increase in surface area would result in a 10-fold reduction in gas adsorption due to contamination.

The filter element 563 may extend into the lumen of the housing 538, for example, between 1 and 3 mm, between 2 and 5 mm, between 3 and 8 mm, between 7 and 13 mm, do. In some embodiments, the exposed implant surface area of the filter element 563 is wider than the surface area exposed in the absence of extension. The relative difference is 20 to 50%, 50 to 150%, 100 to 300%, 300 to 1000%, or more or less.

It should be noted that the structural features and relative advantages described in connection with Figures 5A-5C can be combined and have a synergistic effect, depending on the embodiment. Thus, for example, the requirement to reduce the amount of filter material used is satisfied by the low waste-generating shape in some embodiments. In some embodiments, the shape with the "bite " taken from one side can be attached to keep the surface in the middle along the filter length. In some embodiments, the protrusion complement for this "byte " is not removed, but extends from the other side into the lumen of the mouthpiece to increase the filter injection surface area.

Figure 6 illustrates a combined mechanism for filter pass throughput protection, in accordance with some exemplary embodiments of the present invention. Housing 635 is fitted to filter element 660 to strain gas injection. The injection surface 661 of the filter element 660 can be shaped to increase the area so that the gas is adsorbed into the interior of the filter body.

In some embodiments of the invention, the filter geometry (illustrated in Figures 5A-5C) is considered in combination with an injection strainer (illustrated in Figures 3A-3C). In Fig. 6, an exemplary infusion strainer is shown (shown without an overlying membrane or other channel closure for clarity). The strainer includes a gas injection portion 646, an injection channel 641 and a channel wall 643 surrounding the lumen 623 of the open component housing 635. The filter element 660 is represented in at least two forms of the filter injection surface area. The surface area 663 is a "clean" injection area and is protected by an injection strainer. Conversely, the surface area 661 extends into the lumen 623 without being protected. Although it is exposed to contamination by waste, an increase in surface area may allow sufficient gas to pass through to prevent pressure buildup.

A possible advantage of combining two filter protection forms in one device is that they each act as a backup to each other. Possibly, each protection form is relatively strong in different environments due to, for example, direction or waste concentration.

Figure 7 shows a housing 735 having a shape to lengthen the discharge passage through the filter element 760 according to some exemplary embodiments of the present invention,

In some embodiments of the invention, the minimum filtering path through the filter element 760 is longer than the shortest distance across the filter. The elongated exhaust path can greatly reduce odor by filtering, and / or make way always across the filter element to reduce leakage opportunities. In some embodiments, the inlet surface 761 of the filter element 760 is circumferentially offset from the outlet surface 762. Deflection formed by the enclosed wall causes the exhaust gas lumen 723 to exit radially as well as circumferentially.

In some embodiments of the present invention, the housing 735 includes a groove 780 that conforms to the shape of the filter element 760. In some embodiments, the recess 780 has an opening 781 near the lumen 723 forming the injection surface 761 of the filter element 760 when inserted. In some embodiments, the recess 780 has an outer opening 782 that defines a discharge surface 762 of the filter element 760.

In some embodiments, additional or alternative fences form a filter injection surface 761 and / or an exit surface 762. For example, since the embodiment as shown in Figure 9B described below is applied, the attachment pattern of the pouch film forms a biased injection and ejection surface.

A possible advantage of using a circumferential offset to form a minimal gas filtering path length is that the width of flange 725 can be made narrower than the desired filtering path length. Additionally or alternatively, the filter element 760 can be made narrower than the flange 725, so there is room for a deeper injection protection region 746 to be formed. In some embodiments, the injection region 746 includes an injection sensing aperture and / or a flutter valve.

Figure 8 illustrates a filter element 860 having a shape to combine the design elements described above, in accordance with some exemplary embodiments of the present invention.

In some embodiments of the present invention, the filter element 860 includes a plurality of injection surfaces 861. In some embodiments, the filter element 860 includes a plurality of discharge surfaces 862. In some embodiments, the injection and / or ejection surfaces 861, 862 are formed by openings 881, 882 in the recess 880 in the housing 835.

In some embodiments, the filter element 861 includes a notch region 865 having a shape that replenishes the shape of the attachment region 885 of the housing 835.

In some embodiments, the filter element 860 is joined in a substantially rectangular shape that has been modified to conform to the shape of the recess 880 in the housing 835. The advantage of a rectangle to the filter element is that the filter element can be made from a sheet of filter material that is less consuming in the space between the individual elements cut from the material.

The design of the exemplary filter element 860 is achieved by combining several filter designs already described. Circumferential deflections between the inlet and outlet surfaces increase the filter passageway length. The open central region attaches two retaining surfaces. In addition, useful shapes reduce the consumption of filter material.

It should be noted that the groove 880 represents only one example of a method for suppressing the flow of the filter element 860. By adhesive and / or welding, for example, selectively bonding to the membrane of the waste collection pouch is another method for housing the filter element 860.

pouch- housing  Filter element holder

9A-9B illustrate alternative examples of pockets for holding filter element 960, in accordance with some exemplary embodiments of the present invention. The pockets include the membrane material of the waste collection pouch 950 and open mouth parts housings 935A and 935B. Generally, the rigid body housing can fully or partially conform the filter to the groove. Additionally or alternatively, the membrane may be bulged over some or all of the filter to receive the filter.

In some embodiments of the present invention, the open component housing 935A has a groove 980A that fits the size of the filter element 960. [ In some embodiments, the open pouch 950A is attached to the housing 935A by, for example, gluing or welding. In some embodiments, the holding area of the filter element 960 is formed between the groove 980A and the area 970A of the pouch 950A.

In certain embodiments of the present invention, the open configuration housing 935B is flat. In one example of this embodiment, the pouch 950B portion 970B is inflated over the filter element 960 to press the filter element against the housing 935B.

In this embodiment, the filter element 960 is thicker than the recess 980A and the portion 970B of the open pouch 950B presses the recess.

In some embodiments, the filter element 960 is placed between two support surface portions before or during the encounter. Alternatively, the filter element 960 is positioned between the portion 970A or 970B and the portion 980A or 980B after being attached to the pouches 950A and 950B and the housings 935A and 935B.

10A-10B, a filter element 1060 and a folded pouch 1050 are attached side-by-side to the housing 1035 in accordance with a particular embodiment of the present invention. Potentially, this arrangement prevents the filter entry surface 1061 from being contaminated in the form of a low bond pouch / filter.

The inlet surface 1061 of the filter element 1060 is located above the lumen 1023 of the housing 1035. In this particular embodiment, At the position shown, an internal pore gas is emitted. In some embodiments, the exit surface 1062 is open to the outside of the open mouth mechanism.

In some embodiments, a portion of the folded open pouch 1050 is placed over the filter element 1060 on the housing 1035 surface. Potentially, this configuration prevents the entry surface 1061 from sticking. In certain embodiments, one or more surfaces 1065 of the filter element are sealed such that gas is not drained by, for example, a portion of the pouch 1050.

The potential benefit of assembling the filter element 1060 and the pouch 1050 side by side on the surface of the housing 1035 is to reduce the overall height of the open mouth element.

In a particular embodiment of the present invention, the cover 1040 covers the housing 1035, the pouch 1050 and the filter element 1060 during normal wear. In certain embodiments, the recessed portion 1042 of the cover 1040 seals the pouch 1050 and the filter 1060 in a tight fit. In certain embodiments, the cover 1040 is sealed to the recess 1042 to provide a flat outer surface configuration. In some embodiments, the cover 1040 is removed for disassembly of the pouch 1050. In a particular embodiment, the cover 1040 is completely separated from the open mouth mechanism.

In this embodiment, the cover 1040 has an exhaust hole 1044 so that gas is filtered through the filter element 1060 and then exits the device. In some embodiments, the cover 1040 is pushed outward when an internal pressure is applied through the lumen 1023. It is possible to distinguish between the pressing force due to the gas which can be ventilated by the gas evacuation and the pressing force for discarding by the waste discharge demand.

In another embodiment, a flat fold-back is used with filters in other configurations. For example, it is folded proximally at the front of the filter as in the embodiment of Figs. 1A-1B, 2 and / or 13A-13B.

Insertable / removable filter element and filter holder

Referring to FIG. 11, a removable filter element 1160 of an open subassembly 1100 according to a particular embodiment of the present invention is shown.

In certain embodiments, the openings of housing 1135 and / or recess 1180 are heated by other elements (not shown). For example, the added element may be part of another dog housing or an open pouch.

In certain embodiments of the present invention, the filter element 1160 can be inserted or removed by open reduction during operation (wear) of the open mouth mechanism. In some embodiments, the grip 1167 allows the filter element 1160 to be adjusted to be inserted into or removed from the support 1180. In this embodiment, the grip 1167 is a relatively flexible tab, e.g., a hard plastic, so that the filter can be inserted without distortion. In some embodiments, a hard medium covers the larger surface portion of the filter element 1160 or covers the entire surface. In a particular embodiment, the filter element 1160 is pressure-inserting into an open-ended confinement without protruding tabs. Optionally, the filter element 1160 is withdrawn by pulling a protruding element other than a tab, such as a cord.

The support portion 1180 has one or more snaps 1183 that fit within the recesses 1165 on the filter element 1160. In one particular embodiment of the present invention, In some embodiments, the flexible and resilient snaps 1183 are slightly bent when the filter 1160 is inserted into the support 1180. Snap 1183 fits into recess 1165 when insertion of the filter element is complete. In certain embodiments, a portion of the filter 1160 is bent or pushed during insertion and returns to its position after passing through the snap 1180. [

A potential advantage of the removable filter element 1160 is that the used filter element can be removed and replaced with a new filter element at that location. Optionally, the removable filter element 1160 returns to its original position after it has temporarily fallen or loosened, for example, to overcome over-pressure caused by a sudden mass of gas. The selectively removable filter element 1160 is reused in the new cap subassembly 1100 after the used cap subassembly 1100 is discarded.

12A, a flat filter element 1260 is removably supported within a recess 1280 in accordance with some embodiments of the present invention. The filter element 1260 is secured to at least one side by an insertion element 1270.

In this embodiment, the filter element 1260 of the subassembly 1200A is supported in the recess 1280 of the cap housing 1235A by the support insertion element 1270. [ In some embodiments, the insert element 1270 is sequentially supported by a groove 1271, which is gripped by, for example, a support flange 1284. [ In this embodiment, a portion of the cap housing 1235A separates the surface of the cap housing 1235A bonded to the recess 1280 and the collection pouch. In this embodiment, the separation distance is, for example, 0.3 to 0.6 mm, 0.4 to 0.7 mm, 1 to 2 mm, 2 to 4 mm, 3 to 7 mm, different distances therebetween, Lt; / RTI &gt;

The fixed side of the final opening for supporting the filter element is suitable for use with a potentially replaceable filter. An advantage of the fixed side filter support is that it more reliably supports the filter element in place. There is a potential advantage that a complete annular adhesive can be used to attach the pouch portion to the cap housing if the filter element is not positioned between the cap housing and a portion of the collection pouch. The advantage of separating the lumbar from the surface to be bonded is that it reduces the risk of damaging the filter element due to heat generated during bonding.

12B. In this figure, a cap subassembly 1200B of an opening mechanism according to the present invention is shown. Cap subassembly 1200B has a flat filter element 1260 removably supported within opening 1275 of cap housing 1235B.

In a particular embodiment of the present invention, a filter element 1260 is supported within the opening 1275 of the cap housing 1235B. The fixed side of the support of the filter element is suitable for use with a potentially replaceable filter. The single component construction of the filter support part has a special rigidity. The filter support of this single component construction makes the production cost lower because fewer components are made and fewer assemblies are assembled.

Referring to Fig. 12C, there is shown a filter recessed in housing 1235C by overmolding according to certain embodiments of the present invention.

In this embodiment of the invention, the filter element 1260C is recessed into the cap or adapter housing 1235C by an overmolding technique. In some embodiments, the filter element 1260C is located in a mold used for manufacturing the housing 1235C and the housing material is molded around it.

Potentially this configuration provides the advantage of producing by reducing the manufacturing assembly process. In particular, forming and securing between the filter and the housing ensures a reliable stop against gas exhaust around the filter body edges. For example, in this embodiment, the inner ring 1237 (or other second sealing element) presses the floor 1212 of the wafer 1210 when the housing 1235C is assembled to the wafer 1210. Potentially, this contact inhibits the passage of liquid and / or solid waste but is sufficiently loose to permit gas passage. It also provides an opening in the gas passage. Thus, the gas reaching the second lumen 1238 can be vented through the protective entry surface of the filter 1260C.

In some embodiments, mold assembly does not require a shape with a width that the filter body shape is pushed through the closing aperture. Optionally, the filter 1260C is bent during the fabrication process (e.g., thermoforming) that transforms the filter shape during or prior to overmolding. Potentially, non-planar configuration increases the filtration length of the filter. Also, in a non-planar configuration, the filter can be shaped to avoid other structures of the open mouth mechanism, such as attachment fixture 1239. [

Manual gas release

13A to 13C. Figure 13A shows an open laminar stack 1300 with a transmural gas release valve stem 1395 according to a particular embodiment of the present invention. Figure 13B shows a cross-sectional view of an open laminar stack 1300 of Figure 13A in accordance with an embodiment of the present invention. FIG. 13C shows an enlarged perspective view of the manual gas discharge valve stem 1395 of FIG. 13A in accordance with an embodiment of the present invention.

The pneumatic valves are manually or alternatively operated manually for potentially filtered gas discharge. For example, in the case of sudden gas evolution, the valve can reduce the gas pressure more quickly than with the filter element alone. A pneumatic valve provides a means to test whether the sensed pressure is simply due to the solid / liquid waste or gas opening to vent the gas. In certain embodiments, the pneumatic valve has a safe venting mechanism for gas overpressure. Alternatively, if the filter is clogged and the gas evacuation function is compromised, the operation of the valve can be lane.

In an embodiment of the present invention, the open mouth mechanism 1300 has an actuation valve for manual gas discharge. In certain embodiments, the passive actuated valve has a cell 1345, a stem portion 1395 and / or a second sealing element 1315. In this embodiment, a filter element 1360 for negative pressure gas discharge is provided having a manually actuated valve.

In certain embodiments of the invention, the cell 1345 includes a stem receiving groove 1396 and a stem portion support 1397. In this embodiment, the sealing element 1315 has a stem receiving groove 1398 and a stem portion support 1399.

In certain embodiments, the stem portion 1395 is assembled in an open mouth mechanism and the stem 1394 of the rigid stem portion 1395 is inserted into the opening 1396. [ In this embodiment, the stem 1394 is inserted into the opening 1398. [ In an embodiment, the stem end 1393 has an extension that presses and seals the inner opening of the receiving groove 1398. In certain embodiments of the invention, the extension of the stem end 1393 is partially or fully inserted into the receiving groove 1398. In an embodiment, the stem end 1393 is inclined (e.g., conical) and the narrow end is directed into the receiving groove 1398. In some embodiments, the receiving groove 1398 is inclined to receive part or all of the stem end 1393. [ Optionally, the main body of the stem 1394 is a tether, for example a string. The sling potentially provides a link sized to exert tension between the inner seal 1393 and an external control such as the push button 1392. In Fig. 15E, for example, the stem member 1591A is a string.

In certain embodiments, the stem portion 1395 includes a spring 1391, which is, for example, a leaf spring or a coil spring. In an embodiment, the spring 1391 is formed integrally with the stem portion 1395. The integral formation provides a simpler and less costly advantage than the manufacture of the embodiment in which the spring and stem portions are separate. In an embodiment, spring 1391 presses a portion of stem portion support 1397 of cell 1345. This push pulls the stem end 1393 into the openings of the receiving groove 1398 to maintain the seal.

In some embodiments, the button 1392 cooperates with a spring 1391 (or other tensioner or compressor) to push the stem end 1393 away from the receiving groove 1398. This push off releases the gas seal.

In some embodiments, the stem 1394 is closely inserted into the receiving recesses 1397, 1399 to prevent solid / liquid waste leaks when the gas seal is released. For example, the clearance may be from 0.01 to 0.03 mm, from 0.02 to 0.08 mm, from 0.07 to 0.11 mm, from 0.1 to 0.15 mm, and may be a gap between them or a gap larger or smaller.

The second sealing element 1315 is provided in some embodiments, for example, such that waste is not accumulated on the outside of the pores or in contact with the skin. In an embodiment, this action is for example done by sealing the inner surface of one or more of the open mouth mechanisms. In an embodiment, this action is accomplished by occupying space around the pores and the waste material from the pores is not accumulated outside the pores. In certain embodiments, the second sealing element 1315 performs its function without depressing the pore. In an embodiment, the second sealing element 1315 is made of a flexible material such as, for example, a thermoplastic elastomer (TPE) or a silicone rubber. The hardness meter of the material is in the range of, for example, 30 to 80 Shore A. In certain embodiments, the second sealing element 1315 is a highly elastic material. For example, this material is a silicone rubber having a hardness range of 1 to 30 Shore A, 2 to 20 Shore A, 2 to 15 Shore A, 3 to 10 Shore A, or 3 to 8 Shore A.

Potentially, the ductility of the sealing element 1315 helps form the sealing of the stem portion 1395. In some embodiments, the sealing element 1315 additionally or alternatively limits pore evacuation to the portion of the open wafer 1320 and / or the cell 1345. This restriction reduces leakage through, for example, an external seal, such as the seal 1325 between the open mouth wafer 1320 and the open mouth mechanism cell 1345. Potentially, this restriction reduces emissions to the bottom of the wafer 1320 causing tissue contamination and / or loosening of the pore wafer attachment. In some embodiments, the sealing element 1315 occupies the internal volume of the open mouth mechanism to reduce accumulation of waste within the open mouth mechanism.

In certain embodiments of the present invention, the cell 1345 is made of a flexible material such as TPE or silicone rubber. The flexible material has, for example, a durometer in the range of 30 to 80 Shore A. In this embodiment, the cell 1345 is made of a rigid or medium rigid material, such as polyethylene or polypropylene. In an embodiment of the present invention, the cell 1345 and / or the second sealing element 1315 have sufficient flexibility to simplify valve manufacture. With this construction, the stem 1394 with the extension is pressed from the outside through the openings 1396 and / or 1398 and assembled to the valve.

Referring to Figures 15A-15J, there are shown various piercing valve configurations in accordance with certain embodiments of the present invention. FIG. 15A shows an embodiment valve having similarly positioned components for an open instrument wall 1595 such as the embodiment valve shown in FIGS. 13A-13C. The wall 1595 has a sealing element of a cell and an opening mechanism according to the present embodiment. The button 1592 and the spring 1594 are located on the outer wall 1595. The stem 1591 penetrates the wall 1595 through the opening 1596 and the stopper 1593 and the seal 1599A are inside the wall 1595. 15A to 15H, the large arrow indicates the manual operating force. A small double-headed arrow indicates the direction of force applied to the part of the valve at the indicated height.

In certain embodiments (Figs. 15B and 15D), the stopper 1593 is external to the open mouth mechanism wall 1595. Fig. When actuated, the springs 1594, 1598 or other force pushes the stopper 1593 against the seal 1599B around the opening 1596. Alternatively, the springs 1594 and 1598 (Figs. 15B and 15C) are located inside the opening mechanism wall 1595 and pull the stopper 1593 toward the seals 1599B and 1599A. Optionally, closing the seals 1599A, 1599B is overcome by pulling the seals. In some embodiments, a handle 1597 is provided at the position of the button 1592 to be depressurized.

In some embodiments (Figs. 15C, 15D), spring 1598 and stopper 1593 are present both inside and outside of device wall 1595. In some embodiments, spring 1598 is secured to wall 1595 and valve stem assembly. If no further force is applied, a spring is secured to be placed to pull the stopper 1593 into the sealing areas 1599A, 1599B.

In some embodiments of the present invention (Fig. 15H), sufficient pressure in the device causes stopper 1593 to be released from its sealing position to release gas. Optionally, sufficient pressure is selected as safe and / or comfortable discharge threshold. Depending on the embodiment, sufficient pressure may be, for example, 45 to 55 mmHg, 55 to 65 mmHg, 63 to 78 mmHg, 75 to 90 mmHg, 80 to 105 mmHg, or higher or lower. In some embodiments, such manual release of the pressure relief valve is possible, such as by pulling the handle 1597. [ Optionally, other embodiments of the invention (e. G., Shown in Figures 15B and 15D) are configured to allow gas emission to occur above a predetermined pressure threshold.

In some embodiments of the present invention (Figs. 15F-15G), the shape and / or size of the stem assembly 1591B causes compression of the resilient portion of the appliance wall 1595A for sealing. For example, the stem assembly 1591B is optionally formed with a shaft that is too short to reach the end of the through-hole 1596 through which it is inserted. To reach the end, a force is applied to compress the device wall 1595A and / or to elastically extend the shaft. At the time of insertion, a seal is formed, for example, at 1599C due to the compressive force between the end of the stem assembly 1591B and the wall 1595A. Pressing the button 1592 collapses the seal.

In some embodiments of the present invention (Figs. 15I through 15J), a sealing force is provided by the annular resilient sealing element 1520. Fig. The sealing element 1520 is pushed against a portion of the stem assembly 1505 to press the opening device wall 1525. Optionally, the wall is a close (front) wall of the mouthpiece, e.g. a part of a cover or cap. In some embodiments, the stem 1507 of the stem assembly 1505 passes through the wall 1525 in the aperture 1528. The stem 1507 is secured to the outer surface of the wall 1525 by a control member 1510 with sufficient width to inhibit passage of the through- In some embodiments, when the indwelling force 1530 is applied to the control member 1510, the orientation of the wall 1525 is reversed. The change in direction disrupts the seal between the sealing element 1520 and the wall 1525 so that the gas can drain the device through the through-hole 1528.

In some embodiments, the lower surface 1515 of the control member 1510 is shaped to avoid sealing formation against the wall 1525 when the control member 1510 is actuated. Optionally, the sealing element 1520 includes a filter element body that allows the gas to be released continuously, even when the valve mechanism is in the closed position. Optionally, in other embodiments of the present invention (e.g., Figures 15A-15H), the stopper is permeable to gas (including, for example, filter material) To be changed from fast to fast.

Referring again to Figures 13A-13C, an optional feature of the open dental appliance is that it includes a filter element 1360, a filter element 1360 supported between the disc 1335 and an open mouth waste collection pouch 1350. In some embodiments, the disc 1335 partially accommodates the filter element as in some embodiments (e.g., housings 135, 335, 435). In some embodiments, area 1370 of open mouth pouch 1350 partially accommodates filter element 1360. In some embodiments, In some embodiments of the invention, the filter element housing area 1380 of the disc 1335 includes a recess. In some embodiments, the filter element housing area 1380 is flat. In some embodiments, the material of the filter element 1360 includes at least a portion of the aperture that is sealed within the valve portion. Optionally, the valve member may be actuated to deform a portion of the filter element to permit gas emission by passing the filter.

The housing of the filter element, alone or in combination, comprises different aspects. One aspect is to keep the filter element in place, and another aspect is to seal with a pressure opposite the filter element and / or adhere the gas so that it does not bypass the filter element body. Another is to trace the waste injection to the filter element. Another aspect is sealing to prevent ingress of solids and / or liquids into the filter element.

In some embodiments of the invention, the opening device 1300 includes a cover 1340 to prevent dislodgement while leasing and / or wearing the waste collection pouch 1350. In some embodiments, the apertured wafer 1320 includes a flange to which the attachment mechanism 1325, e.g., shell 1345, is adapted to be attached.

Figures 16A-16B schematically illustrate a manual gas discharge valve, in accordance with some exemplary embodiments of the present invention. Figures 16C-16D also schematically illustrate another gas discharge valve, in accordance with some exemplary embodiments of the present invention.

In some embodiments of the present invention, valve stem end 1629 includes a flared or reversely tapered end. Optionally, the taper extends into the lumen 1627 such that the degree of sealing is controlled to the extent that the region presses against the lumen wall. A possible advantage of the opened valve stem end 1629 is that the discharge velocity of the gas can be controlled by the size of the open gap as the valve member 1632 is released downwardly. Possibly, it is also possible to control the outflow from the valve, as the size of the gap is adjusted to allow, for example, the escape of gas without leaving solid or liquid material.

In some embodiments, a blunt-ended valve stem end 1609 is provided. A valve including a blunt stem end 1609 is relatively insensitive to the amount of exhaust it receives and preferably provides a "all or nothing" reaction to the operation. When exchanging due to loss of controllability, when the pressure is sufficient to effect valve action, the possible advantage of this design is a clear indication (e.g. due to emission noise and / or odor).

In some embodiments, the gas discharge valve members 1603 and 1623 can be inserted into the lumens 1607 and 1627 of the body 1601 and 1621 of the open device component. In some embodiments, the valve members 1603 and 1623 include one or more stationary elements 1605 and 1625 that can be inserted into the receiving apertures 1608 and 1621 in the bodies 1601 and 1628. The receiving apertures 1608 and 1621 are formed or cut into the inside of the bodies 1601 and 1621, for example. In some embodiments of the present invention, valve members 1603 and 1623 include control pressure-receiving regions 1613 and 1633. Control pressure- In some embodiments, the control pressure-receiving regions 1613 and 1633 act as an external spring to allow the stem ends 1609 and 1629 to move in a generally normal position relative to the through-holes of the lumens 1607 and 1627 And an elastic region to be pressed. Optionally, the pressure-receiving regions 1613, 1623 may be depressed (e.g., with fingers) to allow the stems 1611, 1621 to move away from being pulled against the internal apertures of the lumens 1607, 1627 The stem ends 1609 and 1629 are released.

In some embodiments of the present invention, the valve members 1603 and 1623 have a fixed (1605,1625) pressure-receiving area 1613,1623 (including its regressive-spring nature), a stem 1611,1621, Lt; RTI ID = 0.0 &gt; 1609 &lt; / RTI &gt; The molded piece may be made of, for example, polypropylene, polyethylene or other polymer resin. In some embodiments of the present invention, the material surrounding the body lumens 1607,1627 may have sufficient stretch to stretch, even though the stem ends 1609,1629 are larger than the relaxed size of the lumens 1607,1627 , And a material for allowing the valve stem ends 1609 and 1629 to be inserted therethrough.

It is an advantage that valve functions of fixation, tensioning, sealing, and / or control can be incorporated into components that can be manufactured as a single unit for example to reduce costs and / or reduce complexity of manufacturing equipment.

14A to 14B. Figure 14A shows a gas discharge valve stem portion 1495A with a soft sealing tip, in accordance with some exemplary embodiments of the present invention. Figure 14B shows a rotatable gas discharge valve stem portion 1495B to seal or open the gas discharge aperture, in accordance with some exemplary embodiments of the present invention.

In some embodiments, the valve stem portion 1495A is inserted into and seals the interior of the hole in the part of the opening device (e.g., device 1300). In some embodiments, the valve stem portion 1495A includes a stem 1394A having a stem end 1493 adapted for securing with a stem end cup 1496. In some embodiments, In some embodiments, the stem end cup 1496 includes a flexible material such as a thermoplastic elastomer or silicone rubber. In some embodiments, the stem end cup 1496 is used to seal off the evacuation of gas through the hole through which the valve stem 1494A is fixed. A possible advantage of the flexible stem end cup 1496 is that it can be made closer to fix it against the aperture of the hole 1398. [ The flexible stem cup 1496 can be sealed against a rigid surface, e.g., the inner surface of the shell 1345 in embodiments where the second sealing element is not used.

In some embodiments of the present invention, the button 1492A is pressed to deform the resilient spring element 1491 to release the seal made by the stem end cup 1496. In some embodiments of the present invention, the spring element 1492 has a doubly overlaid shape. In some embodiments, at least one safety pin 1497 extending from the spring is received by a compensating hole in, for example, shell 1345. A possible advantage of the safety pin 1497 is to help position the stationary valve stem portion 1495.

In some embodiments of the present invention, the stem end cup 1496 is configured to collapse under sufficient outward pressure from the pores. In some embodiments, the collapse destroys the seals in which the cups 1496 are formed with another portion of the bimetallic device, causing the gas to escape to the outside. A possible advantage of this feature is that it automatically operates at a pressure threshold sufficient to pass and provides a safety valve for manual release of the gas as described above. The pressure causing the collapse is, for example, 47 to 52 mmHg, 55 to 65 mmHg, 60 to 75 mmHg, 70 to 85 mmHg, 80 to 105 mmHg, or higher or lower. An exemplary range of minimum to maximum pressure for causing a collapse may be 5 mmHg, 10 mmHg, 25 mmHg, a range between them, or higher or lower. In some embodiments, a stem valve for automatic pressure release is provided separately from manual pressure release. In some embodiments, another pressure-sensitive means for automatically collapsing the sealing of the stem valve is provided. For example, the stem end 1393 may be sized to pass through the sealing portion of the sealing element 1315 under sufficient outward pressure.

In some embodiments of the present invention, the stem 1494A of the valve stem portion 1495B has a non-circular cross-section, e.g., a lenticular shape. In some embodiments, at least one hole (e.g., hole 1398) to which the stem 1494B is secured has a compensating and securing cross-section. In some embodiments, the release of gas may be activated by rotating the stem 1494B in place. As a result, when the opening 1398 is deformed, a gap is formed so as to discharge the gas. In some embodiments, the lever 1492B is attached to the top of the valve stem portion 1495B projecting horizontally from the shaft of the stem 1494B. When the lever is pressed, the stem shaft 1494B can be rotated and opened for gas discharge.

Pouch-attached filter element

Figure 17A schematically illustrates a filter element 2103 positioned to vent through the material of an open pouch 2100, in accordance with some exemplary embodiments of the present invention.

In some embodiments, the filter element 2013 is attached to the open pouch 2100 at a selected location to enable venting therethrough even when the pouch is folded into a folded configuration. In some embodiments, the vents 2105 include one or more apertures in the pouch material upon which the filter element 2013 is sealed. In some embodiments, the location is defined by one or more of the following: (1) the side of the pouch facing away from the intestinal tract patient or toward the intestine placement patient, (2) the selection of a particular subpanel 2108, and / RTI ID = 0.0 &gt; and / or &lt; / RTI &gt; (3) a particular position and / or orientation in the selected subpanel.

In some embodiments of the present invention, the open pouch 2100 is permanently attached to an inlet 2101 that leads to a housing of another open mouth piece for attachment to the pore. The open mouth parts for attaching the open mouth pouch 2100 include apertures of an open mouth, which can be inserted into an open mouth cap, a wafer, an open mouth adapter and / or a pore. In some embodiments of the present invention, the pouch includes an integral adapter for attachment to another open mouthpiece. It should be understood that the open pouch 2100 represents a general open pouch, and in some embodiments, is composed of different aspect ratios, rounded shapes contrasting with sharp edges and / or sides, different overall contours, and / or different folding patterns . The mouthwash pouch may, in some embodiments, maintain up to about 750 ml of excretion volume or maintain a excretion volume of, for example, up to about 250 ml, 400 ml, 500 ml, 600 ml, or more, less, .

Reference is now made to Fig. 17B which schematically illustrates the detailed structure of a filter element 2103 according to some embodiments of the present invention.

In some embodiments, the filter element 2103 includes a fixed attachment to a portion of the open pouch, e. G., The subpanel 2108. In some embodiments, In some embodiments, the attachment is attachment to the interior of the pouch. Alternatively, the attachment may be an outboard attachment, in which case the "evacuation " and" inlet "parts of the filter are inverted relative to the body of the filter element (i.e. the filter inlet is in the through- Edge region). In some embodiments, portions of the filter element are bonded to both the inside and the outside of the pouch membrane material across the aperture of the pouch membrane material. In some embodiments, at least one surface of the filter body 2102 is sealed against ingress of gas by a sealing element 2104. In some embodiments, the gas enters only through one or more defined inlet portions 2107. In some embodiments, the gas exits through one or more outlets 2105. In some embodiments, the shortest distance between a given inlet 2107 and a given outlet 2105 is configured to ensure a desirable level of odor clearance by the material of the filter body 2102.

In some embodiments, the body 2102 of the filter 2103 is of a structure such as, for example, a felt, cloth, foam, grid, or cake. In some embodiments, the body 2102 of the gas filter 2103 includes an odor absorbing material that filters odorant in the outgoing gas. Additionally or alternatively, the filters may adsorb the odorant, catalyze the collapse and / or conversion of the odorants, or otherwise deodorize the odorants and / or neutralize the odorant . Potentially, the filtered odorant is a hazardous odorant, for example a stool odor. According to this embodiment, odor absorption is by using, for example, activated carbon, silica gel, zeolite and / or carbide-derived carbon. In some embodiments, the filter is preloaded with a flavor and / or odor neutralizing material that absorbs gases that are less harmful to the gas passing through the filter. Potentially, the filtration slows the gas release, so that the external concentration of the odorant is less noticeable to the superficial installation patient and / or others.

Reference is now made to Figs. 17C-17E which schematically illustrate the position of the filter 2103 relative to the folding structure of the open pouch 2150, in accordance with some exemplary embodiments of the present invention.

In some embodiments, the open pouch 2150 is folded into the package while in wear until it is manually or automatically deployed to fill the slurry. During folded wear, the mouthwash pouch 2150, in some embodiments, does not fill the excreta, but retains the retained cover of the pores. Nevertheless, in some embodiments, manual (automatic) gas discharge is performed, for example, by filter means 2103. In some embodiments, the filter element 2103 is contained within the open pouch 2150 in a manner that functions to drain the gas while the open pouch 2150 is folded. In some embodiments, the structure of the pouch helps in the evacuation function of the filter, for example, by protecting the filter from contamination by feces and / or by controlling the rate of gas flow to the filter.

In some embodiments, the substantially folded open pouch 2105 includes a remaining first lid 2110 and a second lid 2110, which can be folded over a central panel portion attached to the mounting element 2109 to complete the folding of the package 2112) (e.g., top and bottom covers). 17C includes folding the pouch of Fig. 17A, for example, and then folding the "wing" comprising three panels on both sides. The 3 × 6 panel has several advantages for use with pores, particularly for use with folded open mouth bags. One potential benefit is that it is well suited for feces in an enclosed compartment with a relatively long aspect ratio, which helps in eliminating pouches without undue risk that the feces are poured back from the inlet aperture. One panel overhang allows expansion while the pouch is being filled, so as to reduce the risk of blocking the inlet when the slurry enters the bag. From the packaging point of view, the two full panel sized blades are sufficient to allow the configuration to take place when the pouch is filled, and also provide sufficient material to neatly fold into a position that provides a clean packaging contour. Likewise, once folded in half, the six panels are neatly folded in two additional steps to complete the package shape. Nonetheless, many pouch shapes and folded shapes include embodiments of the present invention; It should be appreciated that the 3x6 panel embodiment shown in this figure is illustrative and not limiting. In some embodiments, not all panels are shown in full size. The shape of the pouch does not strictly follow the contour and / or orientation of the shape of the panel in some embodiments, it may be rounded or rounded, and the intermediate panel may be cut or otherwise altered.

In some embodiments of the present invention, the filter element 2103 is attached to one of the walls of the material contained in the pouch. As shown, the filter element has a pouch-developed configuration in a wall closest to the patient with a superficial installation, in a panel immediately above the panel with the mounting element attached, near the bottom of the panel, With a distance difference in the range of, for example, 2 to 4 mm, 3 to 6 mm, 5 to 10 mm, or other such medium, larger, and / or smaller range.

In some embodiments of the present invention, folding the lid 2110 up (Fig. 17d) causes the filter to come in front of the package and be located near its top. Optionally, this is done after the cover 2112 is folded up. As shown, the lid 2112 is folded up (optionally) above the lid 2110. The resultant package (FIG. 17E) positions the filter close to the surface of the cover 2112, potentially blocking the vent hole 2105. In some embodiments, the risk of closure is reduced by positioning the filter 2103 (and thus the vent hole 2105) near the non-fixed end of the lid 2112. In some embodiments, the crimping site 2120 is formed by the upper folding of the area 2110. [ In some embodiments, the compression includes at least a partial barrier to the penetration of solid and / or liquid waste into the pouch compartment contained within the panel comprising the filter 2103. For example, the barrier properties of some embodiments of the crimped portion 2120 include that it includes constraints and is located on top of the pouch package, so that the waste must be pushed up before it can potentially contaminate the filter do. In contrast, the pore gas is potentially free to spread to the region of the filter 2103, without being affected by the direction of gravity and / or movement due to the partial constraints contained within the compression region 2120.

18A-18B, which illustrate other configurations of the filters 2201, 2203, 2207, 2205, and 2215 attached to the pouches 2202, 2204 embodiments in accordance with some exemplary embodiments of the present invention, .

The open pouch may, in some embodiments, be folded into a package form that includes, for example, a square, rectangular, pentagonal, hexagonal, or other polygonal shape. Figures 18A and 18B show a folded state in which the open pouch is in an open state (shown), for example, similar to the pentagonal shape of the pouch 2202, or in a shape similar to that of the square panel of the pouch 2204 , And a folding line that can be folded. In some embodiments, the package is placed on one side of the inlet aperture sub-panels 2222, 2224 when folded.

In some embodiments, the filter element may have any shape suitable for limiting the panel in which the filter element is disposed, for example, round filter element 2201, square filter element 2203, rectangular filter element 2205, 2207, 2215). Limitations include, for example, sizing and shaping to avoid crease margins. In some embodiments, the arrangement in the panel is such that the filter draw-out aperture is away from the area likely to be clogged, or the filter draw-through aperture is lifted relative to the potential accumulation of fluid or solid within the folded structure of the pouch.

In some embodiments of the present invention, the pouch panel in which the filters 2203, 2205, 2207 are disposed is selected such that one crease is away from the mouth and into the pouch. This has the potential advantage of separating the gas from other soil materials by the resistance of the wrinkles, without increasing the resistance until the gas clogs. Nevertheless, in some embodiments, the filter element is disposed in two or more pleats beyond the pouch inlet (e.g., filter element 2201, 2215). This potentially increases the separation function to help protect the filter entry area. This potentially slows down the escape of gas from the filter elements 2215, 2201. Although it can also increase reliance on pressure and / or manual venting of the pores, it results in improved odor control for subsequent release. In some embodiments of the invention, the filter flow rate is set to 1 to 10 ml / min, 2 to 5 ml / min, 3 to 8 ml / min or less, or the same, medium, larger, and / Is set to a different flow rate range.

In some embodiments, the panel is above the inlet aperture (filter 2205), below (filter 2215), and / or laterally (filter 2207). In some embodiments, a plurality of filter elements are provided. For example, all of the displayed side filter elements 2207 are provided.

Reference is now made to Figures 18c and 18d illustrating filter elements 2205 and 2215 having at least one side protected from fecal contamination by a sealing element 2212, according to some exemplary embodiments of the present invention. do.

In some embodiments, the filter elements 2205, 2215 may be sealed to one or more sides (e.g., because the pouch excreta inlet is in a direction lying across) that is considered to be the most likely to reach the excreta leakage And has a preferred orientation given by Thus, for example, the filter element 2205 is positioned opposite the long side sealed pouch inlet. In some embodiments, short sides are of course also sealed.

In some embodiments, the seal enables the draw-out aperture 2210 to be positioned closer to the sealed side without reducing the shortest useful path from filter suction to filter discharge. In some embodiments, this allows for a more thorough (if potentially slower) filtration to a given size of filter element. In some embodiments, it is possible to reduce the amount of filter material used. The potential benefit of this is cost savings, another potential benefit is a shrinking effect on the pouch package size, and another potential benefit is that it is closer to the edge of the panel (without increasing the interference to the panel creasing For example, in a less clogged position).

Reference is now made to Figs. 19A and 19B which show a cross-sectional view of an open mouth mechanism 2300 including a flap valve, in accordance with some exemplary embodiments of the present invention.

In some embodiments of the invention, the valve member 2301 is inserted into the lumen 2308 of the open mouth mechanism 2300. In some embodiments, the control surface 2303 is located external to the open mouth mechanism. The valve stem 2309 passes through the lumen 2308 and terminates at the pressure end 2307. [ In some embodiments, the pressurized end 2307 forms a seal against the wall of the lumen 2308. In some embodiments of the present invention, the seal includes a pressurized end 2307 with a reverse taper 2306 (e.g., a conical taper that widens toward the press end) so that back pressure from the pore and / A force from a spring or other tensile member tends to push the tapered region more closely against the wall of the lumen 2308. To open the seal, the valve stem 2309 is advanced into the lumen to open the gap 2320 between the lumen 2309 and the taper 2306 and / or other surfaces in contact with the lumen 2309.

In some embodiments of the present invention, the pressurized end 2307 is configured to contact the valve flap 2305 as it advances within the lumen 2308. In some embodiments, pressing down on the control surface 2303 pushes the pressure end 2307 against the valve flap 2305. In Fig. 19B, valve flap 2305 is shown deflected due to pressure from pressure end 2307. Fig.

In some embodiments of the present invention, the valve flap 2305 serves to prevent flow into the valve body during wear. In some embodiments, the valve flap 2305 is a major or unique seal of the valve assembly. In some embodiments, the valve flap 2305 operates in conjunction with the seal by the valve stem / press end 2307, 2309 against the lumen 2308.

In some embodiments, the valve flap 2305 may be made of a flexible elastomer (e.g., having a Shore A hardness of about 40-60, 50-70, 70-90, or similar, medium, / Or other range of Shore A hardness having a smaller range). In some embodiments, the valve flap 2305 is configured to be generally pushed up against the sealing surface 2310. The gap between the flap 2305 and the sealing surface 2310 is opened when the pressing member 2307 is pushed down on the gap. In some embodiments, flap 2305 is resilient enough to return to its sealing position when released.

The potential benefit of the flap 2305 is to protect the main valve device from contamination by feces, except when the valve is in the open operation. Another potential advantage is to provide the valve with high sealing resistance and / or sealing redundancy.

It will now be appreciated that there is a need in the art for an opening mechanism for an opening device comprising a valve member 1623 protected by secondary sealing members 2020 and 2022 from a pore effluent entering into a pore fenced area 2001. According to some exemplary embodiments of the present invention, Reference is now made to Figs. 20A-20C which illustrate the drawings.

In some embodiments of the present invention, the valve member 1623 intersects between the exterior of the housing 1621, which is an open part, and the pore fence. In some embodiments of the present invention, the sealing elements 2022 and 2020 occupy a space between the pore itself and the valve member 1623. In some embodiments, the sealing elements 2020 and 2022 are gas permeable. Potential advantages include the ability to absorb and / or block liquid and / or solid excrement prior to reaching the vicinity of the valve members 2022 and 2020, to prevent contamination of the valve, and / Thereby preventing leakage in the valve hole which is extended while being extended.

In some embodiments of the invention, the sealing element 2020 extends all the way around the pore fence. In some embodiments, the sealing element 2022 includes a clearance region 2022 in which the valve member 1623 and / or the valve flap 2305 are positioned to receive the intrusion end (e.g., (E.g., during operation), and / or to create a space in which gas can diffuse around valve member 1623. [ Optionally, the foam has sufficient ductility such that no special discharge clearance is required or used.

In some embodiments of the present invention, the sealing elements 2020 and 2022 are foam elements (e.g., composed of a foam polymer such as a flexible polyether-based polyurethane or the like). The foam, in some embodiments, is permeable to allow gas to pass through the foam and reach the discharge valve member 1623. In some embodiments, the cells of the foamed rubber make the fecal particles entering the foam sufficiently small to block the foam and prevent passage of additional fecal material. In some embodiments, the cell diameter may be, for example, an average diameter of less than 50 占 퐉, 100 占 퐉, 200 占 퐉, or less than 300 占 퐉; Or an average diameter that is greater than, less than, or less than another size of the middle. An exemplary density of the foam is 0.25 kg / m ^3, for example. In some embodiments, the density may be greater than or equal to about 0.10 kg / m ³ , 0.20 kg / m ³ , 0.15 kg / m ³ , 0.30 kg / m ³ , Value.

In some embodiments of the present invention, the sealing elements 2020 and 2022 are sized to extend across the opening chamber (from the distal bottom to the proximal end of the chamber), so that they include a complete sealing in this direction do. In some embodiments, the non-compression foam elements 2020,2022 are sized to be larger than the dimensions of the distal-proximal chamber so that they can be compressed during installation to secure the seal. In some embodiments, the sealing elements 2020 and 2022 are attached to at least one side (e. G., The proximal wall 2011) by adhesive or welding. In some embodiments, attachment and / or positioning is accomplished by providing a proximal part with a flange sized to center the sealing elements 2020, 2022 in place. Attaching the sealing elements 2020 and 2022 to the pores may allow the sealing elements 2020 and 2022 to be removed from the pore area along with the proximal part rather than requiring a separate potentially cumbersome repair. And provides a potential advantage of being able to remove it.

In some embodiments of the present invention, the sealing element 2022 is a partial seal that extends to an extent sufficient to prevent the excreta from approaching the valve member 1623, but does not extend completely around the pore itself. In some embodiments of the present invention, the sealing elements 2020 and 2022 act as a feces sink that absorbs excretion exiting the pores and thus is not free to move within the pore fences. In some embodiments, the excreta is rejected (due to hydrophobicity and / or relatively small cell size) by a sealing element. Alternatively, the sealing elements 2020 and 2022 are sized to be placed in close proximity to the pore tissue itself without exerting pressure. Optionally, the sealing elements 2020 and 2022 are spaced from the pores so as not to contact the pores. In some embodiments, the sealing element is provided with a plurality of internal and / or external diameters that allow the pericallious patient to select the size most suitable for his or her pore. In some embodiments, the sealing element includes a series of partially attached foam rings that can be torn to allow a periosteal patient to make a size suitable for his or her pore.

In some embodiments, the sealing elements 2020 and 2022 are produced by cutting the foam sheet, for example, by die cutting. Alternatively, the foam is cast into the desired shape.

As used herein, the term " about "refers to within +/- 10%.

The terms " comprise, ", " comprising, ", "having ", and uses thereof mean" including but not limited to.

The term " consist of "means" including and limited to. &Quot;

The term "consisting essentially of" means that a composition, method, or structure, unless the other element or step and / or part is substantially basic and does not alter the characteristics of the claimed composition method or structure, Steps and / or parts.

The indefinite articles ("a", "an", and "the") used herein include plural references unless the content clearly dictates otherwise. For example, the term " a comound "or" at least one compound "will include a plurality of complexes comprising a mixture.

The terms " exemplary " and "exemplary " mean hereby" provided as an example, instance, or illustration. &Quot; All embodiments described in the "exemplary" and "exemplary" embodiments are not necessarily to be construed as preferred or advantageous over other embodiments, except for the inclusion of features of other embodiments .

The term "optionally " is used herein to mean" provided in certain embodiments and not provided in other embodiments. &Quot; Certain embodiments of the present invention will include a plurality of "optional" features as long as the features do not conflict.

The term "method ", as used herein, is intended to encompass any method, means, technique, or procedure that is known or readily developed to one skilled in the art of chemistry, pharmacology, biology, biochemistry, Means, techniques, and procedures.

Throughout this application, various embodiments of the invention may be presented in a scoped manner throughout this application. It should be understood that the description of the scope approach is merely for convenience and brevity, and should not be construed as a strict limitation on the scope of the invention. Accordingly, the description of ranges should be understood to include all possible subranges, as well as individual values within that range, as specifically disclosed. For example, references in the range of 1 to 6 inclusive include subranges, such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, For example, 1, 2, 3, 4, 5 and 6 should be considered specifically disclosed. This applies irrespective of the size of the range.

Whenever a range of numbers is provided herein, it is considered to include any recited number (fraction or integer) within the stated range. Ranges / ranges "and " ranges / ranges from the first number shown" to "second indicated number ", between the first number and the second number indicated are used interchangeably herein, Th &lt; / RTI &gt; number and all fractions and integers therebetween.

Although the present invention has been described in conjunction with specific embodiments thereof, it is evident to those skilled in the art that various modifications, variations, and alterations will occur. Accordingly, it is intended that such various modifications, alterations, and modifications be included within the spirit and broad scope of the appended claims.

All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference herein . In addition, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. It should not be construed as necessarily inevitable, as the section title is used.

It will be appreciated that certain features of the invention for clarity, which are set forth in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination, or as appropriate to any other described embodiment of the invention. Certain features described in the context of various embodiments are not considered to be an essential feature of the embodiments unless the embodiment is not practicable without the elements.

Claims (50)

An open mouth mechanism having a gas discharge valve,
An oral cavity lumen sidewall defining a portion of a fence for stoma, said lumen sidewall having an aperture through said sidewall;
Across most of the passage through the through-holes of the side wall,
A stopper positioned to block gas outflow through the aperture, and
A control member operable from the outside of said opening mechanism for unblocking said aperture;
Wherein the valve member
Wherein the gas discharge valve comprises a gas discharge valve. The method according to claim 1,
Wherein the valve member includes a connecting member for connecting the stopper to the control member across the aperture. 3. The method of claim 2,
Wherein the stopper, the control member, and the connecting member are integrally formed. The method according to claim 2 or 3,
Wherein the connecting member is resilient and urges the stopper to the closed position under tension. 5. The method according to any one of claims 1 to 4,
And the lumen side wall is compressively deformed with respect to the stopper at the closed position. The method according to claim 1,
And a spring for urging the stopper to the closed position upon compression. The method according to claim 1,
And a spring for urging the stopper to the closed position upon tensioning. 8. The method according to claim 6 or 7,
Wherein the stopper, the control member, and the spring are integrally formed. 9. The method according to any one of claims 1 to 8,
Wherein the stopper includes a filter body that provides a portion of the passage for crossing gas flow out of the lumen side wall and wherein the occlusion position prevents gas leakage through the periphery of the filter body. Having an oral opening. 10. The method according to any one of claims 1 to 9,
Wherein the gas outlet is only shut off below a predetermined threshold of safety internal pressure. 11. The method of claim 10,
Wherein the internal pressure of the open mouth mechanism urges the stopper to move the stopper from the occlusion position above a predetermined threshold of pressure. The method according to claim 10 or 11,
Wherein the predetermined threshold value of the safety internal pressure is between 50 mmHg and 100 mmHg. 13. The method according to any one of claims 1 to 12,
Wherein the occlusion position includes the stopper being pressed against an inner surface of the lumen sidewall. The method according to claim 1,
Wherein the occlusion position comprises the stopper being pressed against an outer surface of the lumen sidewall. The method according to claim 1,
Wherein the stopper includes a member that extends largely through the aperture and wherein movement to move the stopper out of the closed position includes rotation. 16. The method of claim 15,
Wherein the control member includes an outer lever attached to the elongate member and the lever is operable to rotate the elongate member of the stopper such that the gas is evacuable, Instrument. 15. The method according to any one of claims 1 to 14,
Wherein the stopper includes an area flaring toward one end of the valve member and the occlusion position includes a narrow end of the flared area that is at least partially inserted into the through hole to form a seal therewith, Open mouth mechanism with valve. 18. The method according to any one of claims 1 to 17,
Wherein the pores are separated from the stopper by a gas permeable sealing element. 19. The method of claim 18,
Wherein said detachment comprises blocking from reaching said stopper of solid and liquid excrement from said pores. 20. The method according to any one of claims 1 to 19,
Wherein the lumen sidewall comprises a thickness of at least 3 mm, wherein the connecting member extends therethrough. An open mouth mechanism having a filter element,
A sidewall defining a first lumen surrounding the pore; And
A first filter element held in at least the second lumen;
/ RTI &gt;
Wherein the second lumen is a passage in the side wall connecting the first lumen outside the open mouth mechanism. 22. The method of claim 21,
The wall of the second lumen including portions of a base element and a cover element;
The filter element contacting both the base element and the cover element; And
Wherein the base element and the cover element are attached directly to one another on either side of the filter element. 22. The method of claim 21,
The second lumen including a pocket region padded by portions of the base element and the cover element; And
Wherein the base element and the cover element surround the filter element within a circumferentially extending pocket closed on at least two outer peripheral sides. 24. The method according to any one of claims 21 to 23,
The end of the first lumen is closed and the aperture in the side wall lies coplanar with the inner surface of the closed end. 23. The method of claim 22,
Wherein the cover element is inserted into the recess of the base element to form the second lumen. 26. The method according to any one of claims 21 to 25,
Wherein the filter element is replaceable within the second lumen during operation of the open mouth mechanism. 27. The method according to any one of claims 21 to 26,
Wherein an input channel in fluid communication with the input surface of the filter element separates the input surface from the first lumen. 28. The method of claim 27,
Wherein the input channel comprises a membrane material attached over the base element. 28. The method of claim 27,
Wherein the input channel comprises a recessed surface that is covered by a closure element to form a lumen. 28. The method of claim 27,
Wherein the input channel comprises hydrophobic surfaces. &Lt; Desc / Clms Page number 17 &gt; 31. The method of claim 30,
Wherein the hydrophobic surfaces comprise apertures that are small enough to block the water under its own weight of pressure to a depth of the radius of the first lumen. 28. The method of claim 27,
Wherein the input channel comprises at least one valve between the input surface and the first lumen, wherein the input channel is closed when the pressure outside the input channel rises relative to the pressure inside the input channel. Oral apparatus. 28. The method of claim 27,
Wherein the input channel comprises at least one valve between the input surface and the first lumen, wherein the input channel is open when the pressure outside the input channel rises relative to the pressure inside the input channel. Oral apparatus. 34. The method according to claim 32 or 33,
Wherein the valve is a flutter valve. 35. The method according to any one of claims 32 to 34,
Wherein the filter element protrudes into the first lumen. 36. The method according to any one of claims 22 to 35,
Wherein the filter element comprises an open area through which the side wall base element and the cover element are directly connected. 37. The method according to any one of claims 22 to 36,
Wherein the entire input surface by which the gas enters the filter element from the first lumen is biased radially from the closest portion of the exit surface from which the gas exits the filter element externally Oral Organs. 22. The method of claim 21,
Wherein the second lumen comprises portions of the sidewall molded around the filter element. 22. The method of claim 21,
Wherein the positioning of the filter element does not prevent the flow of excreta through the first lumen. 22. The method of claim 21,
Wherein the first lumen is configured to carry feces to enter the feces collection bag and the second lumen provides a channel to avoid the pouch. Instrument. 22. The method of claim 21,
Wherein an input surface of the filter element on the side of the first lumen extends at least five times the range of the surface in one direction and in the other direction. 22. The method of claim 21,
Wherein at least one surface of the filter element is laminated. A method for manufacturing an open mouth mechanism for retaining a filter element,
Disposing a filter element with respect to an end portion of a sidewall defining a lumen of a first retaining portion included in the open mouth mechanism;
Disposing a second retaining portion for the filter element and the first retaining portion; And
Attaching the first retaining portion and the second retaining portion together such that the filter element is retained between the first retaining portion and the second retaining portion;
&Lt; / RTI &gt; The method of claim &lt; RTI ID = 0.0 &gt; 1, &lt; / RTI &gt; 44. The method of claim 43,
Wherein the attaching step is by squeezing the first retaining portion and the second retaining portion with a welding tool. 45. The method of claim 44,
Wherein the welding tool does not squeeze on at least one of the first and second retaining portions over an area of the filter element. 45. The method of claim 44,
Wherein the welding tool is squeezed with reduced pressure on the first retaining portion and the second retaining portion over the area of the filter element. 45. The method of claim 44 or 45,
Wherein the welding tool does not seal the first holding portion and the second holding portion together on an area extending from the lumen of the first holding portion to the filter element. A method for manufacturing an open mouth mechanism for retaining a filter element,
Disposing a second retaining portion with respect to a side wall defining the lumen of the first retaining portion included in the open mouth mechanism;
Attaching the first retaining portion and the second retaining portion together such that a through hole sized to hold the filter element therebetween is left; And
Inserting the filter element into the aperture
Including,
Wherein the body of the filter element comprises a main path of gas conduction through the aperture. 49. The method of claim 48,
Wherein the attaching step is by squeezing the first retaining portion and the second retaining portion with a welding tool. 50. The method of claim 49,
Wherein the welding tool is squeezed with a reduced pressure on the first holding portion and the second holding portion over the area of the aperture.

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