Patent Publication Number: US-2004059306-A1

Title: Pouch for medical use

Description:
[0001] This application claims the benefit of U.S. Provisional Application No. 60/452,585, filed Mar. 6, 2003 and Provisional Application No. 60/412,951, filed Sep. 23, 2002 and is hereby incorporated by reference in their entirety. 
    
    
     
       FIELD OF THE INVENTION  
       [0002] The present invention relates to a pouch for medical use. The term “medical” may include personal hygiene. In one form, the pouch may be a collection pouch (such as an ostomy pouch) for collecting body fluids. One aspect of the invention may relate to a medical pouch including separable inner and outer pouches. Another aspect of the invention may relate to a reclosable medical pouch.  
       BACKGROUND TO THE INVENTION  
       [0003] Two pouch systems (including an inner and an outer pouch) have been suggested as an alternative to a single pouch ostomy system. However, there remains a need for a pouch design that can combine any of convenience of use, ease of disposal, ergonomic design and security and assurance against leaks, for good customer acceptance. There also remains a need for a reclosable pouch system for medical use, that can combine any of convenience of use, ease of use, ergonomic design, security and assurance against leaks.  
       SUMMARY OF THE INVENTION  
       [0004] In a broad aspect, the invention may provide a pouch for medical use.  
       [0005] The pouch may include separable inner and outer pouches.  
       [0006] The invention may additionally include one or more of the following non-limiting features, although additional or alternative features will be apparent to the skilled man on reading the description of preferred embodiments:  
       [0007] (a) (i) The inner pouch may be fastenable to the outer pouch or to a body fitment. Such a body fitment may support the outer pouch.  
       [0008] (a)(ii) The inner pouch may be fastenable by means of an adhesive coupling. The adhesive coupling may include an adhesive member and a non-adhesive member. The or an adhesive member may be mounted on the inner pouch and/or on the outer pouch/body fitment. The adhesive may be a peelable resealable adhesive.  
       [0009] a(iii) The inner and outer pouches may have apertures which are generally aligned when the inner pouch is in an operative position within the outer pouch, at least to permit communication between the interior of the inner pouch, and the aperture of the outer pouch.  
       [0010] (b) (i) The inner pouch may be made of a material that is disintegratable or dispersible, for example, to facilitate disposal of the inner pouch in a flushable toilet.  
       [0011] (b)(ii) The material may be activatable to disintegrate or disperse by addition of an activating agent. The activating agent may be applied directly to the surface of the inner pouch or it may be added to the toilet water. The activating agent may be a pH-modifier and/or a solvent.  
       [0012] (b)(iii) The pouch material may include an interior facing water resistant layer and an exterior facing water disintegratable/dispersible layer.  
       [0013] (c) (i) The pouch (or at least one of the pouches if more than one pouch is present) may have a reclosable opening.  
       [0014] (c) (ii) The pouch (or at least one of the pouches if more than one pouch is present) may include an opening and a sliding zipper for closing the opening. The opening may be at the seam of the pouch. The sliding zipper may comprise a slider having a characteristic to match, or accommodate, a curvature of the pouch (or a path along which the slider moves). The characteristic may be a degree of curvature of one or more guide surfaces or track-engaging surfaces of the slider. Such a characteristic may enable the slider to move smoothly around a non-linear path.  
       [0015] (c) (iii) In the case of a pouch comprising separable inner and outer pouches, the outer pouch may be openable to provide access for removing and/or fitting the inner pouch.  
       [0016] (c)(iv) A wall of the pouch (or at least one of the pouches if more than one pouch is present) may entirely or partly openable. An openable window portion may be defined in the wall, or an aperture may be openable in the wall, or the wall may be openable at its seam.  
       [0017] (d) (i) The medical pouch may be a collection pouch for collecting body waste. The collection pouch may be an ostomy pouch. The term “ostomy” may include any or all of colostomy, ileostomy and urostomy.  
       [0018] Other non-limiting features and advantages of the invention may include providing a pouch design that may meet one or more of the following, generally conflicting requirements: ease of use, ease of disposal of a waste-containing inner pouch; security and assurance against pouch leakage; and/or ease of manufacture.  
       [0019] Further non-limiting features of the invention will be apparent from the following description of preferred embodiments. 
     
    
    
     DESCRIPTION OF THE DRAWINGS  
     [0020] Non-limiting preferred embodiments of the invention are now described, by way of example, only, with reference to the accompanying drawings, in which:  
     [0021]FIG. 1 is a schematic section through a first pouch embodiment;  
     [0022]FIG. 2 is a schematic section similar to FIG. 1, but showing the outer pouch in an opened condition;  
     [0023]FIG. 3 is a schematic section through a second pouch embodiment;  
     [0024]FIG. 4 is a schematic section through a third pouch embodiment;  
     [0025]FIG. 5 is a schematic section through a zipper of the third embodiment;  
     [0026]FIG. 6 is a schematic section along the line VI-VI of FIG. 5;  
     [0027]FIG. 7 is a schematic section along the line VII-VII of FIG. 5;  
     [0028]FIG. 8 is a schematic view showing the outer pouch opened, and the inner pouch just prior to insertion in the outer pouch/just following removal from the outer pouch;  
     [0029]FIG. 9 is a schematic view similar to FIG. 8, with the outer pouch open, but showing the inner pouch fastened to the outer pouch; and  
     [0030]FIG. 10 is a schematic view similar to FIG. 9, but showing the outer pouch closed. 
    
    
     DESCRIPTION OF PREFERRED EMBODIMENTS  
     [0031] The preferred embodiments present various examples of a pouch for medical use. In one form, the pouch is a collection pouch in the form of an ostomy pouch. The preferred embodiments illustrate a multi-pouch system. However, it will be appreciated that principles of the invention may be equally applied to a single pouch for medical use. Corresponding reference numerals may denote corresponding features, where appropriate.  
     [0032] Referring to FIG. 1, an ostomy pouch  10  generally comprises an inner pouch  12  and an outer pouch  14 . The inner pouch  12  may include a front wall  16  and a rear wall  18  secured together around their mutual periphery. The outer pouch  14  may include a front wall  20  and a rear wall  22  secured together around their mutual periphery. For each pouch  12  and  14 , the front and rear walls may be formed of separate sheets secured together, or they may be formed from a common sheet folded at a periphery of the respective pouch  12  or  14 .  
     [0033] The outer pouch  14  may include, in its rear wall  22 , a first waste inlet aperture  24 . An adhesive body fitment  26  may be coupled, fixedly or removably, to the outer pouch  14  around the stoma aperture  24 . The body fitment  26  may include a wafer or pad of a skin-friendly adhesive for securing the ostomy pouch  10  to the peristomal region of a wearer. For example, the adhesive may be a hydrocolloid adhesive. In this embodiment, the body fitment  26  is fixedly secured to the rear wall  22  of the outer pouch  14 , for example, by welding, heat sealing or adhesive, to be integral with the outer pouch  14 .  
     [0034] The inner pouch  12  may include, in its rear wall  18 , a second waste inlet aperture  28 . The second waste inlet aperture  28  may be slightly bigger than the first waste inlet aperture  24 . A first fastener  30 ,  32  may be provided for fastening the inner pouch  12  to the outer pouch  14  or to the body fitment  26 . In the fastened position (not shown), the first and second inlet apertures  24  and  26  may be at least partly, or substantially, aligned to provide communication between an interior of the inner pouch  12 , and the first inlet aperture. Body waste entering the pouch  10  passes directly into the inner pouch  12 . The first fastener  30 ,  32  preferably provides a substantially liquid-tight and/or gas-tight seal, to prevent waste matter from escaping into the outer pouch  14 .  
     [0035] The first fastener  30 ,  32  may be a releasable or separable fastener, to enable the inner pouch  12  to be separated from the outer pouch  14 /body fitment  26 . The first fastener  30 ,  32  may be a mechanical fastener, or an adhesive fastener. Generally, the first fastener may include a first coupling member  30  surrounding or bordering the second waste inlet aperture, for cooperating (mechanically or adhesively) with a second coupling member  32  carried by the outer pouch  14  or the body fitment  26 . The coupling members  30  and  32  may be flat or plate-like, or they may have mechanical engagement profiles.  
     [0036] In this embodiment, an adhesive fastener may be preferred. For example, the first coupling member  30  may be an adhesive faceplate member  30  bordering or surrounding the second waste inlet aperture  28 . The second coupling member  32  may be a non-adhesive receiving surface (or “landing” surface)  32  to which the adhesive member  30  may be attached. The adhesive may of a tacky or non-tacky type. A suitable material for the adhesive member  30  may be a resealable foam tape, such as the type manufactured by 3M company of Minneapolis, Minn., and designated 9776 Foam Medical Tape on Liner. The resealable foam tape  30  may include a closed cell polyethylene foam backing approximately 0.8 mm thick with a hypoallergenic pressure sensitive acrylate adhesive that faces towards the landing surface  32 . Another suitable material is a sheet substrate with pressure sensitive adhesive instead of a foam. In either case, the adhesive may initially be protected by a silicone release paper (not shown) prior to first use of the pouch. The landing surface  32  may be provide by a flexible film of plastics, for example, thermoplastics.  
     [0037] Referring to both FIGS. 1 and 2, a wall, for example, the front wall  20 , of the outer pouch  14  may be partly, or substantially entirely, openable to provide access for fitting or removing the inner pouch  12 . In this embodiment, an openable portion  34  of the front wall  20  may be provided, in the form of a door, flap or hatch portion, to define an access window  35  in the front wall  20 . The access window  35  may be of approximately the same size as the inner pouch  12 , or it may be larger or smaller than the inner pouch. Generally, a larger size may aid easier insertion and removal of the inner pouch  12 . However, the inner pouch  12  is flexible, and may be quite easily inserted or removed through a smaller-size access window  35 . The access window  35  may be larger than the outer periphery of the first coupling member  30  of the inner pouch  12 .  
     [0038] A second fastener  36  may be provided for fastening closed the openable portion  34 . The second fastener  36  preferably provides a liquid-tight and/or gas-tight seal. The second fastener  34  may extend around, or border, a periphery of the openable portion  34  and/or the corresponding confronting edge of the access window  35  in the front wall  20 . The second fastener  34  may, for example, be a zip fastener, a sliding zip fastener, a hook-loop fastener (e.g., Velcro™), a hook-hook (e.g., male-male interlocking) fastener, or a repositionable adhesive fastener (similar to that described for the first fastener  30 ,  32 ), or a magnet fastener.  
     [0039] A deodorising filter  38  may be fitted to one or both of the inner pouch  12  and the outer pouch  14  for deodorising vented flatus. The deodorising filter  38  may be fitted to an interior facing surface of the respective pouch (as in the drawings), or to an exterior facing surface of the respective pouch  12 ,  14 . The deodorising filter  38  may be fitted to communicate with a gas vent aperture (not shown) in the respective pouch wall.  
     [0040] Referring to FIG. 2, in use, in order to insert the inner pouch  12  into the outer pouch  14 , the second fastener  36  is unfastened to release the openable portion  34  of the front wall  20 . The inner pouch  12  may then be inserted through the open access window  35  in the front wall  20 , and pressed into fastening engagement with, for example, the body fitment  26 . In the case of the adhesive member  30  described above, the adhesive member  30  is pressed into adhesive engagement with the landing surface  32  of the body-fitment  26 . Thereafter, the openable portion  34  is closed and the second fastener  36  is refastened (FIG. 1).  
     [0041] Referring again to FIG. 2, in order to remove the inner pouch  12 , for example when the inner pouch  12  has become full, the second fastener  36  is unfastened to release the openable portion  34  of the front wall  20 . The ostomate may then fold back a portion of the inner pouch  12  (not shown), to gain access to the first fastener  30 ,  32 . For example, by folding down the upper portion of the inner pouch, the ostomate may gain access to the upper edge of the first fastener  30 ,  32 . The inner pouch  12  may then be separated from the body fitment  26 , for example, by peeling the first coupling member  30  free of the second coupling member  32 . As can be seen in both FIGS. 1 and 2, the second coupling member  32  may be larger than the first coupling member  30  (or may include one or more extension tabs) to provide a gripping surface or portion  40  that the ostomate can grip to counterbalance the peeling forces, and to at least partly isolate the peeling forces from the body fitment  26 . Once the inner pouch  12  has been separated, the inner pouch  12  can be withdrawn from the outer pouch  14  through the access window  35 .  
     [0042] The inner pouch  12  may be inserted and/or removed while the outer pouch  14  is being worn on the body. Alternatively, the inner pouch  12  may be inserted and/or removed while the outer pouch  14  is not being worn.  
     [0043] The inner pouch  12  may be intended to be disposed of in a flushable toilet. The inner pouch may be of material that is able to withstand body waste and/or other wet contents during normal usage, but is able to disintegrate or at least soften to facilitate disposal in a flushable toilet. The material may be “activateable” by addition of an activating agent to the toilet water, or to the interior or exterior of the inner pouch  12 . For example, the additive may be in the form of a tablet, or powder, or liquid that may be added to the toilet water. Alternatively, the additive may be in the form of a liquid, an aerosol, or cream that can be sprayed or distributed onto the surface of the inner pouch  12  using a spray or other applicator.  
     [0044] In one example, the inner pouch  12  may be made partly, or entirely, of a pH-sensitive polymer that becomes soluble or dispersible in either or both of acid or alkaline conditions (for example, pH below about 4 and/or pH greater than about 10). The activating agent may be an acid or alkaline additive. Example alkaline compounds may include common base chemicals, such as sodium carbonate, sodium metasilicate, sodium hydroxide, trisodium phosphate, metal mixture compounds, etc.  
     [0045] Another means to soften a polymer material of the inner pouch  12  is to use an organic solvent as the activating agent. For example, the polymer material may be a pH-sensitive polymer. At least some pH-sensitive polymers may be based on acrylic acid or acrylate, and may be dissolved in certain solvents relatively quickly, such as acetone, isopropyl alcohol, amino propanol, ethanol amine, etc.  
     [0046] Another possibility may be for the inner pouch  12  to be made partly, or entirely, of a biodegradable polymer that is water resistant (to withstand the waste contents). The pouch material may be “activated”, for example, by spraying a chemical onto the inner pouch  12 , to activate the disintegration for the pouch to become flushable or dispersible in a toilet.  
     [0047] Another possibility may be for the inner pouch  12  to be made partly, or entirely, of a laminate including a water-soluble or water-dispersible polymer as a bulk layer, and a thin layer of a water-resistant coating applied to a surface. For example, the water-resistant coating may be applied to the interior facing surface of the inner pouch  12 , in order to prevent, or at least obstruct, moisture from the collected waste from damaging the integrity of the material. The exterior surface of the inner pouch  12  may, in normal use of the inner pouch, be protected by the outer pouch  14 . However, when the inner pouch  12  is removed from the outer pouch  14  and placed in a toilet, the bulk layer of the laminate may be exposed to the toilet water, and may disintegrate or disperse relatively quickly. The remaining water-resistant coating of the inner pouch  12  may break down physically, as the layer may be too thin to support the weight of the body waste content, or to withstand water agitation during flushing. This technique may not involve any activation agent to activate the material.  
     [0048] Another possibility is a V-shape pouch, with or without the use of a carrier sleeve, such that the pouch can flow in streamlined fashion through the passages of a toilet and any sewer or septic line connected to the toilets.  
     [0049] The inner pouch  12  may be made of, or include, a barrier material to prevent odours from transpiring through the material of the pouch wall  12 . If a deodorising filter  38  is provided on the inner pouch  12 , then the deodorising filter may be sufficiently small that it can be flushed easily in a toilet system without causing blockage. A deodorising filter  38  may be used on the inner pouch  12  even when the inner pouch  12  is not made of, or does not include, a barrier material. A deodorising agent may also or alternatively be coated onto the material of the inner pouch  12  to deodorise any flatus transpiring through the wall material of the inner pouch  12 .  
     [0050] The first coupling member  30  may be removable from the inner pouch  12  prior to disposal, or may itself be made of a material that disintegrates or disperses in the toilet, or may be configured (e.g. sufficiently small) that it does not significantly obstruct flushing and/or can itself be flushed away easily.  
     [0051] The outer pouch  14  may be intended to be used multiple times with replacement inner pouches  12 . For each replacement of the inner pouch  12 , the outer pouch  14  may remain worn on the body or may be removed and then refitted to the body. The outer pouch  14  may be configured to provide protection for the inner pouch  12 . The inner pouch  12  may be more fragile than the outer pouch  14  to facilitate at least partial disintegration of the inner pouch  12  in a toilet. The outer pouch  14  may also provide additional security to collect any waste matter that may accidentally escape or leak from the inner pouch  12 .  
     [0052] The outer pouch  14  may made of one or more conventional pouch materials not optimised for disposal in a flushable toilet. The outer pouch  14  may be made of a coextruded film containing heat sealable material as outer skins, and an odour barrier material in between. For example, the heat sealable material may be Polyethylene (PE), or polypropylene (PP), polybutene (PB), or ethylene vinyl acetate (EVA), or ethylene methyl acrylate acetate (EMA), or ethylene acrylic acid (EAA), etc. The odour barrier material may, for example, be polyvinylidene chloride (PVDC), or ethylene vinyl alcohol (EVOH), or nylons, etc. An example film for the outer pouch  14  may be MF Film™ made by Sealed Air Cryovac, or Saranex Film™ made by Dow Chemicals.  
     [0053] The front wall  20  and/or rear wall  22  of the outer pouch  14  may also include a comfort layer on the exterior surface, to provide a soft, comfortable cloth-like surface. The comfort layer may, for example, be of a non-woven material.  
     [0054]FIG. 3 illustrates a second embodiment very similar to the first embodiment. The main difference in the second embodiment is that positions of the first and second coupling members  30  and  32  are swapped. The first coupling member (e.g., adhesive member)  30  is mounted on the body fitment  26 , and the second coupling member (e.g., landing surface)  32  is mounted on the inner pouch  12 . Arranging the first and second coupling members  30  and  32  in this way may avoid disposal of the adhesive member  30  in the toilet. Instead, the landing surface  32  may be intended for disposal in the toilet as part of the inner pouch  12 . The landing surface may be made of the same activatable and/or disintegratable and/or dispersible material as the inner pouch  12 . The example resealable adhesive referred to in the first embodiment may permit repeated adhesion of the same adhesive member  30 , thereby allowing multiple replacement inner pouches  12  to be adhered, in turn, to the same outer pouch  14  and body fitment  26 .  
     [0055] FIGS.  4 - 10  illustrate a third embodiment very similar to the first embodiment. The main difference in the third embodiment is that the second fastener  36  is integrated in the seam joining the front wall  20  and rear wall  22  of the outer pouch  14 . The openable portion  34  of the front wall  20  may therefore be the entire width of the outer pouch  14 , providing a wide access window  35 . A fixed seam of the outer pouch  14  therefore may not extend around the entire periphery of the outer pouch  14 . Instead the second fastener  36  may extend partly or entirely around the periphery. The second fastener  36  may be any of the fastener types referred to in the first embodiment, but a sliding zipper is preferred and is now described further.  
     [0056] Referring to FIGS.  5 - 7 , a first zipper track  50  may be attached to one of the front and rear walls  20 ,  22  of the outer pouch  14  in FIG. 4 (alternatively, the attachment may be to  20 ,  34  in the embodiments of FIGS.  1 - 3  as the flap opening is on the face instead of the seam), and a second zipper track  52  may be attached to the other of the front and rear walls  20 ,  22  of the outer pouch  14  in FIG. 4. The first and second zipper tracks  50 ,  52  may be male and female tracks, respectively. The zipper tracks  50   52  may be generally curved to match the curved peripheral shape of the outer pouch  14  (for example, as seen in FIGS.  8 - 10 ). A zipper slider  54  may be captive on the tracks  50  and  52  for fastening and unfastening the zip tracks  50 ,  52 . The slider  54  may be generally channel shaped, and include a bridge  56  and two depending side walls  58  defining a channel region  60 . The side walls  58  of the slider  54  may carry guides  62  that engage behind the tracks  50 ,  52  to hold the slider  54  captive on the tracks. The channel region  60  may be narrower at one end  54   a  (e.g. the right as seen in FIG. 5) of the slider  54  than the other end  54   b . Moving the slider  54 , for example, leftwards fastens the zip by pressing the male and female tracks  50 ,  52  into mutual engagement with each other. A pressing projection  64  located near the end  54   a  of the slider  54  may aid application of pressure to urge the tracks  50 ,  52  together. Moving the slider  54 , for example, rightwards unfastens the zip by separating the male and female tracks  50 ,  52 . Separation may be aided by a separation projection (blade)  66  depending from the bridge  56  and/or by a difference in the height of the guides  62  at the end  54   b  of the slider to promote lifting of one track relative to the other.  
     [0057] As best seen in FIG. 5, the slider  54  may have a curved characteristic that matches and/or accommodates the curved shape of the zipper tracks  50 ,  52 . The curved characteristic may define a curvature that is not significantly smaller (e.g., radius of curvature is not significantly greater) than the maximum curvature (e.g., minimum radius of curvature) of the periphery of the outer pouch  14  over which the zip extends. For example, the curved characteristic may be an interior surface  56   a  of the bridge  56 , which has a curvature that is not significantly smaller than the maximum curvature of upper periphery of the pouch. (The bridge surface  56   a  may be shaped to have a radius of curvature that is not significantly greater than the minimum radius of curvature of the upper periphery of the pouch). The bride  56  may act as a guide for guiding movement of the slider  54  relative to the tracks  50 ,  52 . Additionally or alternatively, the curved characteristic may be defined by surfaces  62   a  of the guides  62  that confront the zipper tracks  50 ,  52 . The guide surfaces  62   a  may be inclined or curved along an arc  68  having a curvature that is not significantly smaller than the maximum curvature of the upper periphery of the pouch. (The arc  68  may have a radius of curvature that is not significantly greater than the minimum radius of curvature of the upper periphery of the pouch).  
     [0058] Such a curved characteristic may enable the slider  54  to slide smoothly around the curved shape of the outer pouch  14 . This may be especially advantageous for the elderly or less dextrous, or for ostomates with sensitive stomas who wish to avoid discomfort as the slider  54  is operated.  
     [0059] Referring to FIGS.  8 - 10 , the second fastener (zipper)  36  may extend for a half, or more, of the periphery of the outer pouch  14 . In the form illustrated, the length of the zipper  36  may be about two-thirds, or more, of the periphery. Such a length of zipper  36  allows the inner pouch  12  easily to be inserted in, or removed from, the outer pouch  14 , and it may also provide substantially unhindered access to the first fastener ( 30 ,  32 ) for removably securing the inner pouch  12  in position.  
     [0060] The zipper  36  may be arranged to open an upper portion of the outer pouch  14 . Opening an upper portion may be advantageous in providing access to the stoma aperture. A lower portion of the outer pouch  14  may have a permanently sealed seam  70 . The permanently sealed seam  70  may act as a failsafe to ensure that the inner pouch  12  cannot accidentally drop downwardly out of the outer pouch  14 .  
     [0061] The zipper may be made of any suitable material, such as metal or plastics or fabrics.  
     [0062] The invention, particularly as described in the preferred embodiments, can provide a pouch design that may meet multiple, generally conflicting requirements, in terms of ease of use, ease of disposal of a waste-containing inner pouch, security and assurance of the wearer against pouch leakage, and ease of manufacture.  
     [0063] The foregoing description is merely illustrative of preferred forms of the invention, and does not limit the invention. The skilled man will appreciate that many alternatives may be used within the principles and/or scope of the invention.