WO2011142928A1

WO2011142928A1 - Indwelling fecal drainage catheter and fecal collection or ostomy pouch

Info

Publication number: WO2011142928A1
Application number: PCT/US2011/032282
Authority: WO
Inventors: Mingliang Lawrence Tsai
Original assignee: Convatec Technologies Inc.
Priority date: 2010-05-13
Filing date: 2011-04-13
Publication date: 2011-11-17

Abstract

A chlorine dioxide releasing compound is used with a fecal management catheter and/or a fecal collection pouch (e.g. an ostomy pouch). The chlorine dioxide releasing compound releases, when activated in use, chlorine dioxide gas that permeates within the catheter and/or pouch. The chlorine dioxide gas is a strong oxidizing agent. The chlorine dioxide gas is highly effective in (i) controlling odor; and (ii) eliminating problematic bacteria such as C-diff and MRSA.

Description

INDWELLING FECAL DRAINAGE CATHETER AND

FECAL COLLECTION OR OSTOMY POUCH

Field of the Invention

One aspect of the present invention relates to an indwelling fecal drainage catheter, having a distal portion for insertion into rectum for drainage of feces. Another aspect relates to a collection receptacle for fecal waste, for example, in the form of a pouch. The collection receptacle may collect the fecal waste drained through the catheter, or it may collect waste from a stoma.

Background to the Invention

Indwelling fecal management or drainage catheters are utilized to capture and contain liquid or semi-liquid fecal matter of non-ambulatory hospital patients. This has multi-fold benefits including: the prevention of contamination of a patient's skin from corrosive effluent; reduction of risk of contamination caused by potentially infectious material; and minimization of soiling of the bedding.

Conventional fecal drainage catheters are typically made of silicone rubber, which has excellent biocompatibility with body tissue, and is soft and compliant. An example is described in US-A-2005/0054996.

A potential disadvantage with silicone rubber is that it has a relatively high gas permeation rate. Malodors emanating from the fecal waste transported within the catheter may permeate through the catheter wall, and create unpleasant smells. This is embarrassing for the patient, and unpleasant for caregivers attending to the patient. Depending on the design of the catheter, additional odor barrier material may be used to improve the odor barrier properties of the catheter. However, adding odor barrier material adds to the cost and complexity of production. Also, if the odor barrier is a film coating on the catheter, it is technically difficult to attach a coating to silicone rubber material. The integrity of the coating may be damaged by flexing of the catheter in use, allowing small odor leaks. The human nose is extremely sensitive to such odors, and can detect even small leaks.

A further issue that is becoming increasingly important in hospitals and other health-care settings is the problem of bacterial infection from feces. Bacteria from fecal matter, if not properly contained, can lead to nosocomial infections. For example, E. coli and Clostridium difficile ("C-diff") are known to cause spread of infections in health care settings, where germs spread easily, antibiotic use is common, and people are especially vulnerable to infection. Instances of C-diff and methicillin resistant Staphylococcus aureus ("MRSA") have been increasing in recent years, and both C-diff spores and MRSA are resistant to some antibiotics. C-diff is found in the colon, and is spread mostly in the form of spores from feces through cross contamination via fecal shedding, toilets and commodes, and hands of caregivers. The spores are difficult to kill with most conventional household cleaners, both alcohol-based or non-alcohol based hand sanitizers, so some usual disinfection measures (e.g. as used against MRSA) are not effective against C-diff spores. People become infected by touching items or surfaces contaminated with feces or spores from feces, and then touching their mouth or nose. Caregivers are also prone to spread C-diff if proper hand sanitization or hand wash is not followed. In devising the present invention, the inventors have appreciated that although the use of a catheter can reduce risk of infection by containing the fecal waste, there is also a further hidden issue not hitherto appreciated. The internal surfaces of the catheter may be contaminated, and the spores may be released in some concentration when the catheter is removed and handled, or when the collection receptacle is removed for emptying or disposal.

C-diff spores are extremely difficult to eliminate. In recent years, one of the key claims of indwelling fecal catheters or fecal pouches is the containment of C-diff spores. However, the spread risk of C-diff spores remains due to the leakage in indwelling fecal catheters or fecal pouches, and the skin contact by caregivers during patient care, change over, and disposal. Bleach is the only disinfectant registered as a C-diff sporicide with FDA. However, the use of bleach has many limitations, including strong chlorine smell, corrosion (i.e., strong base) to skins and hard surfaces, broad reactivity to other contact surfaces besides microbes (i.e., clothes), harmful by-products after oxidation, etc. On the other hand, alcohol based (i.e., ethyl alcohol, isopropyl alcohol) or non-alcohol based (i.e., Benzalkonium chloride, Triclosan) hand sanitizers are gaining popularity. Although these commercial hand sanitizers are the first line defense against bacteria, they are ineffective against C- diff spores which have become a key source of nosocomial infections due to feces.

Waste collection pouches are also vulnerable to leakage of odor, especially at a time of removal of the pouch for emptying, change over, or disposal. Even if the pouch itself is made of material having good odor barrier properties, odor is prone to leakage through the entrance aperture at the time of removal. Handling the pouch may also risk contamination by C-diff spores and other bacteria/viruses in the same manner as discussed above.

It would be desirable in this difficult field to enhance odor control and/or reduce risk of bacterial infection.

Summary of the Invention

The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the invention. It is intended to neither identify key or critical elements of the invention nor delineate the scope of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the more detailed description that is presented later.

Broadly speaking, one aspect of the invention is the provision of a chlorine dioxide (CIO₂) releasing compound for releasing, when activated in use, chlorine dioxide gas. The chlorine dioxide gas is a strong oxidizing agent. The chlorine dioxide gas has the following properties:

(i) the gas is highly effective in controlling odor; and

(ii) the gas is highly effective in eliminating bacteria such as C-diff, both vegetative form and spore form, and MRSA.

Chlorine dioxide is a strong oxidizing agent in a way similar to bleach (sodium hypochlorite), but without many side effects commonly associated with bleach which were mentioned earlier. Besides bleach (i.e., sodium hypochlorite) and chlorine dioxide, there are other oxidizing agents that known to be antimicrobial agents, including hydrogen peroxide, chlorine, iodine, peracetic acid, etc. Except chlorine, most oxidizing agents are liquids . The drawbacks of chlorine are similar to bleach, such that its use in the indwelling fecal catheters or pouches is limited. Hydrogen peroxide at a concentration safe for human use is very slow to kill bacteria. Recently, the drawback of hydrogen peroxide was improved based on a prior art described in US Patent 6,346,279, where a phosphoric acid and an anionic surfactant were added to accelerate the activity of hydrogen peroxide. Even with this improved formulation, the acidic nature of hydrogen peroxide at a pH = 3 or less is still a concern for likely skin irritation. Being a liquid, hydrogen peroxide is less effective in odor control than chlorine dioxide gas. In contrast, the inventor has found that use of chlorine dioxide is significantly more beneficial than other oxidizing agents mentioned above for the fields of fecal collection/management. In more detail:

The invention is highly advantageous for fecal drainage or management catheters, where odor control has hitherto been difficult to achieve. The invention can also render the fecal drainage catheters safe to handle for caregivers, and reduce the risk of infection and spread of bacteria in vulnerable care-giving settings. The use of chlorine dioxide surprisingly provides excellent, fast-acting odor and bacteria protection that distributes over the entire length of the catheter, which is difficult to achieve using barrier- only properties. The use of chlorine dioxide also has the advantage that it follows the same airborne characteristics as odor and spore distribution from the catheter when handled, which enhances efficacy of the chlorine dioxide.

The invention is also highly advantageous for fecal waste collection receptacles (e.g. fecal pouches or ostomy pouches). The invention can provide fast-acting odor control at the time when the pouch is most vulnerable to odor leakage, namely at the time of removal for empting or disposal. The invention can also render the pouch safe to handle for caregivers, and reduce risk of infection in vulnerable care-giving settings. The use of chlorine dioxide also has the advantage that it follows the same airborne characteristics as odor and spore distribution from the receptacle when handled, which enhances efficacy of the chlorine dioxide.

The invention has been devised despite use of chlorine dioxide in fecal drainage catheters and/or in fecal collection receptacles being counter-intuitive. Chlorine dioxide is a gas and is most effective when freshly generated. It is not self- evident how gas may be effectively generated or used for a catheter or waste collection receptacle. In addition, the release of chlorine dioxide is short lived. Without the sustained release of chlorine dioxide, there is limited benefit of the released chlorine dioxide in the prior art. The sustained release herein is defined as an extended time period of at least 10 minutes, or preferably at least 1 hour, or more preferably at least 1 day. Prior art from other fields is not easily transposable for a catheter or waste collection receptacle. For example, US Patent No. 4084747 teaches that chlorine dioxide can be released using a two-component mixing from solutions containing sodium chlorite and an acid. However, it is not self-evident how such solutions could be applied for fecally incontinent patients. US Patent No. 5360609 discloses a polymeric coating on a film, which releases chlorine dioxide upon the coated film being contacted by moisture. However, such a coating would be extremely difficult to apply to a catheter made of silicone rubber. US patent No. 7273567 describes use of energy, particularly UV light, to activate the release of chlorine dioxide using a catalyst and reaction with an anion. However, such a technique has little practical application to a fecal management catheter or fecal waste collection pouch worn by a patient in normal settings.

Although features believed to be of importance are highlighted herein and in the appended claims, protection may be sought for any novel feature or idea described herein and/or illustrated in the drawings whether or not emphasis has been placed thereon.

Brief Description of the Drawing:

Fig. 1 is a schematic section illustrating a fecal drainage appliance in a first embodiment of the invention.

Fig. 2 is a schematic section illustrating a fecal drainage appliance in a second embodiment of the invention

Fig. 3 is a schematic section illustrating a fecal drainage appliance in a third embodiment of the invention.

Fig. 4 is a schematic section illustrating a fecal collection pouch in a fifth embodiment of the invention;

Fig. 5 is a schematic section illustrating a chlorine dioxide releasing material pack in fifth to seventh embodiments of the invention;

Fig. 6 is a schematic section illustrating a chlorine dioxide releasing material envelope for a towlette in an eight embodiment of the invention; and

Fig. 7 is a schematic section illustrating a chlorine dioxide releasing material envelope for a towlette in a ninth embodiment of the invention. Detailed Description of the Invention:

Fig. 1 illustrates generally a fecal drainage appliance 10 having a distal portion 12 insertable into the rectum 8 of a wearer to collect fecal waste. The appliance is used to manage fecal waste. The appliance 10 is illustrated in the form a catheter tube 14, although the appliance 10 may have any suitable form. A proximal portion 16 of the appliance 10 is coupled, or coupleable via a separable coupling 18, to a fecal collection receptacle 20, here illustrated as a pouch. A drainage passage 22 extends in the tube 14 from the distal portion 12 to the proximal portion 16 for transporting body waste from the body to the effluent collection device 20. In the illustrated embodiments, the drainage passage 22 has a permanently open mouth 24 at the distal portion, so that fecal waste can enter the drainage passage 22 unvalved. This is believed to contribute to avoiding concentration of pressure on body tissue in the region of the distal portion 12. However, in other embodiments (not shown), a valve (e.g., an inflatable balloon) may be provided for selectively closing the mouth 24 to entry of fecal waste until evacuation is desired. The tube 14 is made of silicone rubber, or some other soft, flexible and biocompatible material such as polyurethane, latex, synthetic rubbers, or thermoplastic elastomers. A characteristic of such materials is that they are substantially liquid impermeable, but have relatively poor gas barrier properties, for example, an air transmission rate of about at least 10,000 cc/m²/day at 23°C for silicone rubber based on ASTM D3985.

The distal portion 12 comprises a distensible cuff 26, for engaging internal body tissue when the distal portion 12 is in situ in the body. The cuff 26 extends peripherally (e.g., circumferentially) around an outer surface of the catheter tube 14 at the distal portion 12, and is such that the cuff 26, when distended, defines an outward projection or shoulder with respect to the surface of the tube 14. The cuff 26 serves to retain the distal portion in situ once inserted into the rectum, and/or the cuff 26 serves to effect a seal to divert the body waste into the appliance 10 as the only exit for the body waste. A fluid conduit 28 optionally extends to the cuff 26 for permitting introduction of a fluid to distend the cuff 26. The fluid may a gas or liquid. The cuff 26 is made of silicone rubber, or some other soft, flexible and biocompatible material such as polyurethane, synthetic rubbers, or thermoplastic elastomers as discussed above. The cuff 26 may be made of the same material as the tube 14. The cuff wall material may be thin, for example, having a thickness in the range of about 0.4 mm or thinner, and having a higher gas transmission rate than the tube 14 of greater wall thickness if made of the same material.

The collection receptacle 20 is illustrated as a pouch, although it will be appreciated that other forms of receptacle, such as bottles, may also be used as desired. In the first embodiment, a liquid solution made from (or comprising) a two- component chlorine dioxide releasing compound is used to inflate the cuff 26. The solution is introduced into the cuff via the conduit 28. Upon mixing the two components, a chemical reaction begins to release chlorine dioxide. Due to the relatively high gas transmission rate of the wall material, chlorine dioxide release from the solution within the cuff permeates through the cuff wall and into the rectal cavity. From the rectal cavity, the gas also permeates into, and along the length of the tube 14. Since the interior of the cuff 26 represents a closed system (i.e. not open to atmosphere), the liquid solution will not dry out, resulting in a sustained release of chlorine dioxide over an extended period of days. At the same time, the arrangement avoids direct contact between the liquid solution and the rectal cavity. If a two-component chlorine dioxide releasing solution is applied instead directly into the rectal cavity, there could be an issue of liquid containment inside the rectum by a fecal catheter over time. Furthermore, the direct application would not achieve the sustained release of chlorine dioxide since the fecal output would continue to wash away the injected chlorine dioxide releasing solution; thus limiting the effectiveness of chlorine dioxide to minutes in most cases.

The two-component formulation used in this and other embodiments described below preferably comprises a first component of a metal chlorite (for example, sodium chlorite), and a second component of an acid (for example, acetic acid, oxalic acid, citric acid, lactic acid, hydrochloric acid, etc.). Such a system is based on the acidification of chlorite. In addition, at least one component may optionally further comprise a catalyst (for example, metal oxide, potassium persulfate or potassium perborate) to accelerate the reaction to release chlorine dioxide. Other possible components include color pigments, skin protectants (such as petrolatum, soft paraffin, aloe, etc.), refreshing odorants (i.e., peppermint, mint oil, etc.), thickeners (such as sodium cellulose), etc. The additional of a thickener may increase the ability to sustain release of chlorine dioxide over time. Other examples of chlorine dioxide releasing reactions include oxidation of a metal chlorite by chlorine, oxidation of a metal chlorite by hypochlorite, reduction and acidification of a metal chlorate by oxalic acid, reduction of a metal chlorate with sulfur dioxide, etc.

In one test, two rectal catheters of a type substantially as described in the aforementioned US-A-2005/0054996 were provided. The cuff of one catheter (the test catheter) was inflated using approximately 45cc of a two-component chlorine dioxide releasing compound. The cuff of the other (the control catheter) was inflated with water. Each catheter was subject to two tests. The test involved placing the distal portion of the catheter into a first bag containing chopped onions, an especially pungent odor source. The first bag, and the catheter were then placed into a second bag to enclose the whole assembly, and prevent odor decay. In the first test for each catheter the quantity of chopped onions was 6.5 grams, and in the second the quantity was 13 grams. The onion odor was checked every two hours.

In the control catheter where water was used to inflate the cuff, the onion odor was noticeable in about 5 minutes, and the onion smell was very strong after 30 minutes. In the test catheter, onion odor was not noticeable within 5 minutes of cuff inflation, and onion odor remained unnoticeable for both test catheters for 5 days. It was noted that in the control device, the onion odor became rancid after 2 days. But no rancid smell was observed in the test catheter. It is believed that not only did the chlorine dioxide control the onion odor, but the chlorine dioxide also eliminated the bacteria as a part of onion spoilage.

The volume of fluid within the cuff 26 is important to maintain correct distension of the cuff 26 to achieve a reliable seal and/or to anchor the distal portion 12 in position in the rectum. In the above test, even after 2 weeks, the volume of the chlorine dioxide solution had only reduced to 42cc, i.e. a reduction of less than about 7%. Therefore, the test confirmed that the release of chlorine dioxide does not have a significant adverse effect on the inflation volume of the cuff 26.

Referring to Fig. 2, the catheter 10 of the second embodiment is similar to that already described, except that an additional lumen 40 is provided extending at least partly in the catheter 10 to the distal portion 12. The lumen 40 may be used for injecting irrigation fluid for irrigating the catheter tube 14.

Whereas water or saline is conventionally used to irrigate a fecal catheter, in the second embodiment, a solution made from two-component chlorine dioxide releasing compound is used instead of water or saline. Upon mixing of the two components, a chemical reaction begins to release chlorine dioxide. The two- component solution is injected into the rectum via the irrigation lumen 40. The chlorine dioxide releasing solution contacts the rectum and then flows inside the tube 14 into the collection receptacle 20. Since the chlorine dioxide solution flows inside the fecal catheter, and since the fecal catheter is a substantially closed system, the chlorine dioxide gas will continue to be released. The time period of sustained release of chlorine dioxide depends on the amount of fecal output.

In one test, two rectal catheters of a type substantially as described in the aforementioned US-A-2005/0054996 were provided. About 6.5 grams of chopped onions was distributed roughly evenly along the length of the drainage passage 22 of each catheter. About 25cc of a two-component chlorine dioxide releasing solution was used to irrigate one of the catheters (the test catheter), and water was used to irrigate the other (the control catheter). A fecal collection pouch was connected to the end of the catheter, and the onion odor was checked every two hours. For the control catheter, the onion odor was noticeable after about 5 minutes. For the test catheter, onion odor was unnoticeable from 5 minutes up to 5 days, similar to the test result of the first embodiment.

Referring to Fig. 3, the catheter 10 of the third embodiment is similar to that already described for the first and/or second embodiment, but includes a lumen 42 that is closed at the distal end 12. The lumen 42 may be permanently closed at the distal end. The lumen 42 may also not be open to the drainage passage 22. The lumen 42 may extend substantially the entire length of the tube 14 (which may be different from the inflation conduit 28 and the irrigation conduit 40 which may be truncated at the point where the lumen passes through the wall of the tube 14). Although not illustrated in Fig. 3, the catheter may also include an irrigation lumen as in Fig. 2. The chlorine dioxide releasing solution (e.g. two-component) is introduced into the lumen 42. Owing to the relatively high transmission rate of the material forming the wall of the lumen, the chlorine dioxide gas permeates through the wall of the lumen 42 into the drainage passage 22. The chlorine dioxide gas may permeate along substantially the entire length of the catheter. The chlorine dioxide solution can remain substantially closed within the lumen 42. This can alleviate any concern over contact of the liquid solution with the body tissue, for example, in the rectum.

In a fourth embodiment, a chlorine dioxide releasing coating is applied to an inner wall surface of the tube 14 (e.g. as indicated in Fig. 1 at 44). The coating may be substantially continuous, or discontinuous. For example, a discontinuous coating may comprise a spot pattern. The coating is responsive to contact with fecal matter to start the chemical reaction to release chlorine dioxide.

In one example, the coating is responsive to moisture in fecal output. The aforementioned US 5360609 (the content of which is hereby incorporated by reference) describes a coating formulation incorporating sodium chlorite and an anhydride, that can be used to release chlorine dioxide when the coating is in contact with moisture. However, the coating described in US 5360609 cannot be coated onto silicone material. In this example, two options are possible to use the coating of US 5360609. One option is to employ a different material for the tube 14. Example materials on to which the chlorine dioxide generating material of US 5360609 may be coated include polyurethane and/or a thermoplastic elastomer. Another option is to use a primer on the silicone material before the coating is then applied.

In another example of the fourth embodiment, the coating is responsive to acidity in fecal output. Acute diarrhea is common in those who are fecally incontinent in intensive care units or hospitals. The fecal output in the case of acute diarrhea is acidic with a pH, for example, of at least about 5.5 (e.g. in a range of 5.5 to 7.0). For example, a metal chlorite containing coating can be utilized, such as that described in US 3967039. An advantage of using metal chlorite is that no anhydride moiety need be included in the formulation. Upon contact with acidic diarrhea, the metal chlorite coating will release chlorine dioxide. Such a metal chlorite containing formulation can be applied onto the wall of a silicone, a polyurethane or a thermoplastic elastomer. Optionally, a catalyst (for example, metal oxide, potassium persulfate or potassium perborate) can be added to speed up the reaction. In addition, one or more thickeners can be added, such as sodium cellulose. The additional of a thickener may increase the ability to sustain release of chlorine dioxide over time.

Referring to Fig. 4, a fifth embodiment illustrates a chlorine dioxide releasing compound used in a fecal collection pouch 20. The pouch 20 may be a collection receptacle for use with a fecal drainage catheter tube 14, or the pouch 20 may be an ostomy pouch. The pouch is made of flexible plastics film. Optionally, the film is of, or includes a laminate containing, material that has good gas barrier properties. For example, the film may include at least one layer of ethylene vinyl acetate (EVA), and at least on layer of a gas barrier layer, for example, polyvinylidene chloride (PVDC). The pouch may be formed by joining together front 50 and rear 52 walls of plastics film around a peripheral weld seam 54. An entrance connector 56 may be provided in one face of the pouch, or in the peripheral weld seam. The entrance connector 56 may be configured to releasably attach the pouch 20 to the tube 14, or to a bodyside ostomy mounting wafer (not shown). The entrance connector 56 may be of a mechanical interference type coupling or it may be a peelable adhesive coupling. Alternatively, the entrance connector 56 may comprise a wafer of skin- friendly adhesive for attaching the pouch 20 directly to peristomal skin.

The pouch 20 may optionally include a flatus vent 58 for permitting flatus to escape from the pouch 20 and avoid the pouch ballooning. The vent 58 may be provided with a deodorizing filter 60 to supplement the odor control techniques of the present invention, or the vent 58 may omit a deodorizing filter.

In the fifth embodiment, the chlorine-dioxide releasing compound is disposed within the pouch 20. The chlorine-dioxide releasing compound may be of a two- component mix that begins releasing chlorine dioxide when the components are mixed together, or it may be of a compound that is activated by contact with fecal output (for example, responsive to moisture or acidity in the fecal output).

In the case of an ostomy pouch 20, the chlorine dioxide can permeate throughout the pouch volume to provide effective odor and bacteria control. Even when the pouch 20 is removed for disposal or emptying, the chlorine dioxide within the pouch can be effective in preventing malodors from escaping from the aperture at the entrance connector 56. The chlorine dioxide is also effective in killing bacterial spores and viruses, thereby reducing the risk of contamination when the pouch is removed.

In the case of a fecal collection pouch 20 for use with the catheter tube 14, the chlorine dioxide can permeate retrograde along the tube, from the proximal portion 16 to the distal portion 12, to provide effective odor and bacteria control within the pouch 20 and along the length of the tube 14.

In one test, two rectal catheters of a type substantially as described in the aforementioned US-A-2005/0054996 were provided, each with a fecal collection pouch for coupling to the proximal portion 16. About 6.5 grams of chopped onions was distributed roughly evenly along the length of the drainage passage 22 of each catheter. About 25cc of a two-component chlorine dioxide releasing solution (at 80 in Fig. 4) was applied into the pouch of one catheter (the test catheter assembly), and water was applied into the pouch of the other (the control catheter assembly). The onion odor was checked every two hours through the silicone wall material of the catheter. For the control catheter assembly, the onion odor was noticeable after about 5 minutes. For the test catheter assembly, onion odor was unnoticeable from 5 minutes up to for 5 days, similar to the test result of the earlier embodiments, and illustrating the surprisingly beneficial effect that chlorine dioxide gas may have in permeating throughout the catheter and pouch assembly.

In another example of the fifth embodiment, a sachet (48 in Fig. 4) containing metal chlorite powders is used in the pouch 20. The metal chlorite powders are responsive to acidity in acute diarrhea to release chlorine dioxide gas. The activation is quick owing to the acidic nature of acute diarrhea. No additional reaction components are needed, in contrast to, for example, US 6077495 describing a metakaolin microsphere structure containing sodium chlorite to sustain release of chlorine dioxide based on the metakaolin structure.

Optionally, a catalyst (for example, metal oxide, potassium persulfate or potassium perborate) can be added to speed up the reaction. In addition, one or more thickeners can be added to the metal chlorite powders, such as sodium cellulose. The additional of a thickener can increase the ability to sustain release of chlorine dioxide over time.

Referring to Fig. 5, a sixth embodiment is illustrated in the form of a pack 60 containing two stable, mixable components for generating chlorine dioxide gas. The pack 60 may be in the form of a sachet or blister. The pack 60 is divided into a first compartment 62 containing one component, and a second compartment 64 containing the other. It is preferred that the contents of at least one, and preferably each, compartment are in the form of a gel, although liquids and/or solids (e.g. powder) are also envisaged. A gel may provide for better stability, and sustained release of chlorine dioxide after mixing. For example, the compartment 62 may contain material comprising or based on sodium chlorite. The compartment 64 may contain material comprising or based on lactic acid and an optional catalyst. The pack 60 can be torn open to dispense the two components. In one form, the pack 60 is configured with independent tear regions (not shown) to permit the two components to be dispensed individually for manual mixing. In another form, the pack 60 is configured with a combined tear region (not shown) to permit the components to be dispensed together. Upon mixing the compound begins to release chlorine dioxide gas. The mixed compound is applied manually into a pouch 20 (e.g. on to a wall of a pouch 20 such as at 46 in Fig. 4), or to the wall of the catheter tube 14 (e.g. at 44 in Fig. 1 ). A seventh embodiment is similar to the sixth embodiment, referring to Fig. 5. In the seventh embodiment, the pack 60 is modified such that a compartmental wall between the compartments 62 and 64 is configured as a flange seal 66. The flange seal is configured to be easily frangible or penetrable by manual manipulation or squeezing of the pack 60. In use, just prior to dispensing the compound, the pack 60 is squeezed, or pressure is applied to one of the compartments. This causes the flange seal 66 to rupture, allowing the components to mix together. Alternately pushing on one compartment, followed by the other, for a few times (e.g. 6 or 7) will mix the components thoroughly. The pack 60 is then torn open to dispense the premixed compound. The compound may be applied into a pouch 20, or applied to the wall of the catheter 14. An advantage of the seventh embodiment is that the two components can easily be mixed together without contact with the user's hands.

An eighth embodiment is similar to the seventh embodiment, referring again to Fig. 5. A principal difference is that at least one wall 68 (or wall portion) of the pack 60 is made of gas permeable material or film. A suitable permeable material may be selected from: polyethylene film, polypropylene film, a film made from synthetic rubber, silicone, polyurethane, synthetic rubbers, thermoplastic elastomers, "BreathWay" membrane made by Landec Inc., a microporous film or breathable film made by RKW or Print Pak. Preferably, the material has a gas (e.g. oxygen) transmission rate of at least 1 ,000 cc/m²/day, or more preferably at least 10,000 cc/m²/day at 23°C based on ASTM D3985.

In use, upon applying pressure to rupture the flange seal 66, followed by alternating pressure to the first and second compartments to mix the components within the pack, the compound will begin to release chlorine dioxide gas. The pack 60 can remain unopened. The chlorine dioxide gas permeates through the permeable wall (portion) 68. The pack 60 can be placed inside a fecal collection pouch 20 without tearing the pouch open. An advantage is that this provides for efficient release of chlorine dioxide gas while minimizing the contact of the chemicals onto the hands, or skin, of the users during use.

Referring to Fig. 6, a ninth embodiment is illustrated in the form of an envelope 70 for a towlette 72. The envelope 70 comprises first and second compartments 74 and 76, each containing a respective component of a two- component chlorine dioxide releasing compound in liquid form. For example, one compartment may contain sodium chlorite in liquid or gel form, and the other may contain lactic acid and an optional catalyst. The towlette 72 is initially arranged within one of the compartments so as to be soaked with the respective component in that compartment.

In use, the towlette 72 is removed from its compartment and inserted into the other compartment so as to mix the components on the towlette 72. The towlette 72 carrying the mixed components is then placed inside a fecal collection pouch 20, in a similar manner to that described above.

Referring to Fig. 7, a tenth embodiment is illustrated that is similar to the ninth embodiment. The principal difference is that the envelope 70 comprises an additional stowage compartment 78, in which the towlette is initially stored in a dry state. In use, the towlette 72 is removed from the stowage compartment 78, and then inserted sequentially into the first and second compartments 74 and 76 in order to pick up, and mix, the components of the chlorine dioxide releasing compound. The towlette 72 carrying the mixed components is then placed inside a fecal collection pouch 20, in a similar manner to that described above.

It will be appreciated that the foregoing description is illustrative of preferred forms of the invention. Many modifications, improvements and equivalents may be within the scope of the invention.

Claims

1 . A combination of:

a fecal drainage catheter having a distal portion for insertion into the rectum, and a drainage tube for draining fecal output from the rectum; and

one or more materials for releasing chlorine dioxide gas when activated, the chlorine dioxide gas permeating along the drainage tube for odor and bacteria control. 2. The combination of claim 1 , wherein the drainage tube comprises at least one material selected from: silicone rubber, latex, synthetic rubber, thermoplastic rubber, thermoplastic elastomer, styrenic elastomers, polyurethane.

3. The combination of claim 1 , wherein the drainage tube comprises material having a gas transmission rate of at least 1000 cc/m²/day at 23°C based on ASTM

D3985.

4. The combination of claim 1 , wherein said one or more materials comprise first and second components of a two-component chlorine dioxide releasing compound formed by mixing the first and second components together, the mixing together activating the release of chlorine dioxide.

5. The combination of claim 4, wherein the first component comprises a metal chlorite, and the second component comprises an acid.

6. The combination of claim 5, wherein the metal chlorite is sodium chlorite.

7. The combination of claim 5, wherein the acid is selected from the group consisting of acetic acid, oxalic acid, citric acid, lactic acid, hydrochloric acid.

8. The combination of claim 1 , wherein said one or more materials comprise a metal chlorite.

9. The combination of claim 1 , wherein said one or more materials comprise a catalyst. 10. The combination of claim 9, wherein said catalyst is a metal oxide.

1 1 . The combination of claim 1 , wherein said one or more materials comprise color pigments, skin protectants, refreshing odorants, or thickeners. 12. The combination of claim 1 , wherein at least one of the materials is in a form selected from: a liquid; a gel; a powder.

13. The combination of claim 1 , wherein the one or more materials are activated to release chlorine dioxide in response to contact with at least one selected from: moisture; an acidic environment.

14. The combination of claim 1 , wherein the fecal drainage catheter comprises a distensible cuff at the distal end, the distensible cuff for insertion into the rectum, and wherein in use said one or more materials are introduced into the cuff in liquid form to release chlorine dioxide gas which permeates through the cuff.

15. The combination of claim 1 , wherein the fecal drainage catheter comprises an irrigation lumen for delivering irrigation fluid to the distal portion of the catheter, and wherein in use said one or more materials are introduced in liquid form through the irrigation lumen to the distal portion, to release chlorine dioxide gas.

16. The combination of claim 1 , wherein the fecal drainage catheter comprises a lumen that is closed at the distal portion such that an interior space of said lumen does not communicate directly with an interior space of the drainage catheter, the lumen being made of material permeable to gas, and wherein in use said one or more materials are introduced in liquid form through said lumen, to release chlorine dioxide gas which permeates through the wall of the lumen into the interior space of the drainage catheter.

17. The combination of claim 1 , further comprising a fecal collection receptacle for collecting fecal output from the drainage tube, and wherein in use said one or more materials are disposed within the fecal collection receptacle to generate chlorine dioxide gas therewithin, the gas permeating along the drainage tube towards the distal portion.

18. The combination of claim 1 , wherein the release of chlorine dioxide is sustained for at least 10 minutes. 19. The combination of claim 1 , wherein the release of chlorine dioxide is sustained for at least 1 hour.

20. A combination of:

a pouch for collecting fecal waste; and

one or more materials for releasing chlorine dioxide gas when activated, in use the chlorine dioxide gas permeating within the pouch for odor and bacteria control.

21 . The combination of claim 20, wherein the pouch is an ostomy pouch.

22. The combination of claim 20, wherein the pouch is a fecal collection receptacle for collecting fecal output from a rectal drainage catheter.

23. The combination of claim 20, wherein said one or more materials comprise first and second components of a two-component chlorine dioxide releasing compound formed by mixing the first and second components together, the mixing together activating the release of chlorine dioxide.

24. The combination of claim 23, wherein the first component comprises a metal chlorite, and the second component comprises an acid.

25. The combination of claim 24, wherein the metal chlorite is sodium chlorite.

26. The combination of claim 24, wherein the acid is selected from the group consisting of acetic acid, oxalic acid, citric acid, lactic acid, and hydrochloric acid

27. The combination of claim 20, wherein said one or more materials comprise a metal chlorite.

28. The combination of claim 20, wherein the release of chlorine dioxide is sustained for at least 10 minutes. 29. A pack comprising first and second compartments containing, respectively, first and second components of a two-component chlorine dioxide releasing compound formed by mixing the first and second components together, the mixing together activating the release of chlorine dioxide. 30. The pack of claim 29, wherein the pack comprises material having a gas transmission rate of at least 1000 cc/m²/day at 23°C based on ASTM D3985.

31 . The pack of claim 29, wherein the pack comprises a frangible wall separating the first and second components, whereby in use, the wall is rupturable by manual manipulation of the pack, to permit mixing of the first ad second components within the pack.

32. The pack of claim 29, wherein the pack comprises at least one wall portion of gas permeable material, to permit chlorine dioxide gas generated within the pack to permeate through the wall portion.

33. The pack of claim 29, wherein at least one of the components has a form selected from: liquid; gel; powder. 34. The combination of claim 29, wherein the first component comprises a metal chlorite, and the second component comprises an acid.

The combination of claim 34, wherein the metal chlorite is sodium chlorite.

36. The combination of claim 34, wherein the acid is selected from the group consisting of acetic acid, oxalic acid, citric acid, lactic acid, and hydrochloric acid

37. The combination of claim 34, wherein said one or more materials comprise a catalyst.

38. A combination of:

an envelope comprising first and second compartments containing, respectively, first and second components of a two-component chlorine dioxide releasing compound formed by mixing the first and second components together, the mixing together activating the release of chlorine dioxide; and

a towlette movable from one compartment to the other, to mix the two components together on the towlette, the towlette being configured and dimensioned to be insertable into a fecal collection pouch for effecting odor and bacteria control for fecal waste.