Ostomy tools, and systems and processes for their use Number:7,090,664 from the United States Patent and Trademark Office (PTO) owispatent

Title: Ostomy tools, and systems and processes for their use

Abstract: Waste management for people with an ostomy (ostomists), and who therefore find it necessary to wear an ostomy bag, is accomplished simply through processes, systems and ostomy tools involving versatile latent tubes. Such tools include ostomy bags, filters, connectors and conveyance vessels. The tools are particularly helpful, for example, in controlling the location and disposition of ostomy wastes (and their odors) when the ostomist performs challenging routine to unusual tasks associated with ostomy care and maintenance. The tools also help to instill confidence in the users' ability to carry on normal daily business and social activities without creating embarrassment or discomfort for themselves or others.

Patent Number: 7,090,664 Issued on 08/15/2006 to Holter

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Inventors:	Holter; Dwight Jerome (Naples, FL)
Appl. No.:	10/677,816
Filed:	October 2, 2003

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Current U.S. Class:	604/332
Current International Class:	A61F 5/44 (20060101)
Field of Search:	604/277,327,332-345,355 55/361-382

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References Cited [Referenced By]

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U.S. Patent Documents

	2054535		September 1936		Diack
	2667167		January 1954		Raiche
	3055368		September 1962		Baxter
	3690320		September 1972		Riely
	3759260		September 1973		Nolan et al.
	3908656		September 1975		Binard
	3972727		August 1976		Cohn
	4084590		April 1978		Caraway
	4211224		July 1980		Kubach et al.
	4274848		June 1981		LaGro
	4296749		October 1981		Pontifex
	4367742		January 1983		Ornstein
	4411649		October 1983		Jensen et al.
	4451258		May 1984		Jensen
	4457758		July 1984		Norton
	4479818		October 1984		Briggs et al.
	4490145		December 1984		Campbell
	4512771		April 1985		Norton
	4579658		April 1986		Moller
	4654037		March 1987		Fenton
	4810250		March 1989		Ellenberg et al.
	4863447		September 1989		Smith
	4911699		March 1990		Fenton
	4986824		January 1991		Steer
	5250042		October 1993		Torgalker et al.
	5401264		March 1995		Leise
	5470325		November 1995		Fundock
	5643234		July 1997		Losko et al.
	5658266		August 1997		Colacello et al.
	5658267		August 1997		Colacello et al.
	5683372		November 1997		Colacello et al.
	5728080		March 1998		Suyama
	5840073		November 1998		Olsen
	6007525		December 1999		Martell
	6050983		April 2000		Moore et al.
	6135986		October 2000		Leisner et al.
	6165159		December 2000		Blauton
	6241712		June 2001		Steer
	6328719		December 2001		Holtermann et al.
	6918898		July 2005		King

Foreign Patent Documents

	36 08 933		Oct., 1987		DE

Primary Examiner: Zalukaeva; Tatyana
Assistant Examiner: Bogart; M. G.

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Claims

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What is claimed is:

1. An ostomy bag comprising: (a) a main chamber with an upper extremity having at least one upper extremity seal; and (b) at least one multiple-use latent tube co-formed with said main chamber, said multiple-use latent tube having a proximal end firmly attached to, opening to and capable of fluid communication with said main chamber upper extremity, said latent tube further: (b1) having a defined length to a distal end capable of providing axial gas flow out of said tube; and (b2) as co-formed with said main chamber, having two seals which, except for said attachment, are separated from said upper extremity seal, one latent tube seal proximate to said upper extremity seal of said main chamber and one latent tube seal distal to said main chamber upper extremity seal.

2. An ostomy bag in accordance with claim 1, wherein said main chamber and said latent tube have front-side and body-side walls, and the front-side wall of said main chamber is made of the same kind of material as the front-side wall of said latent tube, and the body-side wall of said main chamber is made of the same kind of material as the body side-wall of said latent tube, and wherein, said proximate latent tube seal as formed is generally equidistant from said upper extremity seal along a substantial part of said length of said proximate latent tube seal.

3. An ostomy bag in accordance with claim 1, in combination with at least one filter in fluid connection with said distal end of said tube, for filtering the gaseous outflow from said ostomy bag.

4. An ostomy bag in accordance with claim 3, wherein a connector is attached in fluid connection by axial insertion into said tube distal end and said filter is connected to said connector.

5. A combination in accordance with claim 3, wherein said filter is also a connector.

6. An ostomy bag in accordance with claim 1, wherein said bag includes a plurality of multiple use latent tubes co-formed with said main chamber, at least two said multiple-use tubes each having a proximal end opening to and capable of fluid communication with said upper main chamber extremity, at least one of said tubes having a distal end capable of providing axial fluid flow out of said tube.

7. An ostomy bag in accordance with claim 6, wherein said bag includes two multiple use tubes co-formed with said main chamber, each of said two tubes having a distal end capable of providing axial fluid flow out of it.

8. An ostomy bag in accordance with claim 6, wherein each of said multiple use tubes is separately closeable near its respective proximal end.

9. An ostomy bag in accordance with claim 1, wherein said main chamber upper extremity has a perimeter edge, and at least said distal end of said latent tube has a perimeter edge that is proximate to and in separable connection with a portion of said main chamber upper extremity edge.

10. An ostomy bag comprising: (A) a main bag chamber having an upper extremity; (B) a multipurpose latent tube co-formed with and external to said main bag chamber, said latent tube having a proximal end attached to and opening to said main bag chamber upper extremity and providing the capability for fluid communication with said upper extremity, said tube also having: (1) a distal end; and (2) significant latent tube length between said proximal end and said distal end, at least a substantial part of said length as co-formed being parallel to and separably attached to said main bag chamber.

11. An ostomy bag in accordance with claim 10, wherein said distal end and said significant latent tube length between said proximal end and said distal end are unattached to said main bag chamber.

12. An ostomy bag in accordance with claim 10, wherein said distal end is capable of providing axial gas flow out of said tube.

13. An ostomy bag in accordance with claim 11, wherein said distal end is capable of providing axial gas flow out of said tube.

14. An ostomy bag in accordance with claim 10, further including a closure means for closing said tube said closure means coformed with said bag.

15. An ostomy bag comprising: (A) a closure means: (B) a main bag chamber having an upper extremity; and (C) a multipurpose latent tube co-formed with said main bag chamber, said latent tube having a proximal end attached to and opening to said main bag chamber upper extremity and providing the capability for fluid communication with said upper extremity, said tube also having: (1) a distal end; and (2) significant latent tube length between said proximal end and said distal end, at least a substantial part of said length as co-formed being parallel to and less than firmly attached to said main bag chamber, wherein said closure means comprises a blank area firmly attached to said main bag chamber proximate said tube proximal end, said blank area having at least one slit therein through which said latent tube can be inserted, wherein said slit is in fluid communication with neither said main bag chamber nor said tube.

16. A stomal waste management system comprising multiple use latent tubing having: (a) front and back walls comprising thin, flexible, water impermeable plastic, said latent tubing further having at least one channel having a flat width dimension no greater than one inch and at least two end openings, at least one of said openings being a proximal end through which gas can enter said tube, which latent tubing takes tubular form as necessary for gas flow therethrough, and wherein said latent tubing has at least one pair of spaced apertures in one of its walls to accommodate attachment of a filter with appropriately mating apertures, said latent tubing further having at least one interval seal between said spaced apertures to route gas out of said tubing and into said filter.

17. A stomal waste management system in accordance with claim 16 wherein said latent tubing has a plurality of: (a) pairs of apertures, and (b) interval seals, to accommodate a plurality of filters.

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Description

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BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to systems, processes and tools for management of human body solid, liquid and gaseous wastes, including collection bags and other tools used for minimizing personal negatives for people who must use collection bags of the kind having an inlet aperture for connection of the bag directly or indirectly to a person's skin surrounding a surgically established waste outlet commonly referred to as a stoma.

2. Background Art

A stoma, an outlet through the abdominal wall, is created, for example, during surgery for an intestinal disorder, such as colon cancer, in which it had been necessary to remove or otherwise incapacitate the patient's rectum, leaving the patient without the natural means for controlling waste discharge. Collection bags for attachment to the human body for collecting body wastes are often referred to as ostomy bags (or as ostomy pouches). People who have had an ileostomy or colostomy find it necessary to use the bags to help manage their uncontrolled discharge of flatus gas, liquid and fecal solid material.

Several different designs of ostomy bags are commercially available. Many are pictured in miniaturized outline form and described in detail in commercial catalogs, for example, from Edgepark Surgical, of Twinsburg, Ohio, a company that sells ostomy products from several different manufacturers. Commercially available ostomy bags come in various sizes and shapes generally ranging from about 10 to 15 cm (4 and one half to 6 in.) wide, and about 10 to 25 cm (6 to 10 inches) long, or even longer if the bag has a discharge channel. Such bags usually comprise a body-side wall (i.e. intended to face, be nearer to, the user's body, sometimes referred to herein as the proximal wall or rear wall) and an opposing frontal-side wall (sometimes referred to herein as the distal wall or frontal wall). Each of these walls normally has a base that is a gas- and liquid-impermeable, heat sealable thermoplastic material. The internal surfaces of the frontal-side and body-side wall materials are sealed to each other at or near their perimeters, thus defining an interior chamber of the bag between the walls. The proximal walls of commonly used bags have near the top of each bag (as it is worn by the user) a circular stomal aperture. In a bag referred to as a two piece bag, that aperture is circumscribed by a relatively firm plastic ring, for attachment to a mating ring of an ostomy wafer that is adhesively attached to the skin surrounding the stoma. The attachment of the two rings is intended to provide a liquid and gas impermeable junction. One of the most common attachments uses a protruding, male circular ring member on the ostomy wafer and a female circular recess on the ostomy bag. As the rings are mated with pressure applied the rings snap into mating connection with the plastic protruding ring surrounding the proximal wall stomal aperture. In a corresponding "one piece bag" the means for attachment of the bag directly to the body is an integral part of the bag. But for the thickness of the ring member or other attachment means, most currently available ostomy bags as viewed from an edge are approximately the thickness of a fine line drawn by a fine line pen. Accordingly, even though such bags are described in recent art as having "chambers," until something enters the bag the chambers really are two face-to-face flat pieces of plastic sealed around their perimeter. From a word precision standpoint such bags could be said to be a "latent chamber" or have a "chamber precursor." That is, (except where and to the extent the walls are sealed together and where appropriate port closure is provided) such bags have opposing walls that are readily separated from each other, for example, when gas, liquid and/or solids enter the bag. The result of the material entering the bag is to develop the three-dimensional character of the "chamber", i.e. convert the chamber precursor into a chamber. This distinction has importance that will be discussed further below. For purposes of clarity, when the term "chamber" is used herein (unless otherwise indicated) the term is intended to include both "chamber precursor" and "chamber".

The art generally refers to ostomy bags as one piece or two piece, and drainable or closed. Drainable ostomy bags usually have a narrowed, elongated portion ending in a discharge opening at the bottom of the bag. The narrowed, elongated portion accommodates closure members such as those described in U.S. Pat. No. 6,336,918. Such bags are normally closed by folding the narrowed portion over a blade of a removable closure device and forcing the blade and folded portion into a mating crevice in the device to form a gas and liquid impermeable closure. Closed bags have no opening at the end of the bag and are normally used in situations where the bag is either discarded after use or removed temporarily for washing.

Prior art devices have attempted to make the use of ostomy bags more comfortable to users, referred to herein as ostomists. One improvement that has been made, for example, is to include a comfort layer, a thin external layer of flexible, "breathable" fabric or thermoplastic covering the external surface of the proximal wall that would routinely come into contact with the body of the ostomist. Such a comfort layer reduces the discomfort of the plastic against skin feeling.

Many ostomists try to live a normal lifestyle and can, indeed, be very active. Nonetheless, even for those who are justifiably optimistic because they have beaten a deadly disease like colon cancer, problems persist. For example, for ostomists there is a whole new definition for the term "waste management!" Some of the most significant challenges ostomists face are associated with handling their personal day-to-day waste management chores and situations. Shortly after becoming one, an ostomist is quickly slapped in the face with first hand knowledge that some "natural products" are not pleasant, and that the smog index is not their most important air quality problem. The ostomist in public life has to be aware of his or her ostomy bag and the extent to which it is leaking its vile odors to the surrounds. Odor control or avoidance is still a major air quality challenge facing the ostomist, whether the ostomist is in a car pool, an office, an all day business meeting, a dinner party, or at home with the family! Controlling the problems associated with flatus gasses can be a particularly difficult challenge for those who still have a major portion of their small intestine but have had a significant portion of their large intestine removed. Evidently, because of the increased probability of flatulence and because the smell of the gas is extraordinarily foul, a number of attempts have been made to provide the ostomist confidence and comfort in controlling emission into and out of the ostomy bags. U.S. Pat. No. 6,135,986 ('986), for example, describes a number of prior art attempts to include filters and venting systems to deal with these problems. The patent (986) also outlines shortcomings of those prior art attempts. Those prior art attempts offer some improvements for both drainable and closed ostomy bags. The proposed solutions come in a wide variety of alternatives, for example, of filtering devices. However, problems still exist. Convenience, comfort, confidence and reasonable cost are extremely important for the ostomist. Filter mechanisms get clogged, resulting in bags becoming precariously expanded or, the filters get bi-passed. Even filters placed in the upper extremity of bags tend to get clogged. When ostomists are lying down or even in a sitting position, fecal emission collects around the stoma and can plug tiny holes used in a number of prior art filter systems. Those using gas permeable membranes are particularly susceptible to this type of clogging. If the filters do not operate effectively to allow the gasses to pass through them and deodorize that gas, the filters either emit their horrible odors or inhibit gas flow causing the bag to inflate. The latter can cause leakage of gas through the otherwise reasonably secure ring "seal" connecting the bag to the wafer, or can even cause the ring seals to disconnect, and the bag to pop off the wafer. The result is the release of foul smelling flatus gas, or worse! In addition, the solutions offered in the prior art (including in the '986 patent) tend to be relatively expensive. This is a critical factor to most ostomists and their insurers.

Even though a major ongoing concern for the ostomist is associated with flatus gasses, using an ostomy bag with no filter is still the option of choice of many less than content ostomists. As indicated above, the no filter or plugged filter alternatives leave the ostomist with an uncomfortable and sometimes embarrassing need, that of manually venting (deflating) the bag. Manual venting systems described in the prior art, for example, those described in U.S. Pat. Nos. 5,693,035, and 2,054,535 tend to be somewhat cumbersome and costly, thus limiting their acceptance. Accordingly, manual venting is routinely accomplished by many ostomists through the sequential steps including: (a) seeking and finding a private location; (b) opening or raising a garment (thereby exposing the top of the wafer/bag ring connection); (c) opening the connection partially (thereby breaking the original seal between the bag ring and the wafer ring; (d) applying slight pressure on the bag to release the gas into the atmosphere; (e) snapping the connection into complete closure; and, then (f) flapping the garment to fan the odor away. However, the odor is not one to release in a friend's bathroom! Even very strong bathroom ventilators are inadequate to deal with the penetrating and lasting odor. "Experts" have suggested lighting matches or candles. They help, but not adequately, and not at all in "no smoking" public toilet areas. Then there is the problem with the odor being retained in or on an undergarment, or the flapped garment. Also, periodically breaking the seal between the wafer and bag rings can result in a weakened seal or fecal material finding its way into the seal junction thereby increasing the risk of odor leak through the seal. Odor control agents (odor counteractants) applied in the bags tend to be messy and insufficiently effective and, therefore, do not solve the problems. Thus, many ostomists choose the no filter option with no built in vent system simply because there is not an attractive cost- or functionally-effective alternative. Some ostomists even choose fasting before a social event and/or avoidance of socialization to avoid creating uncomfortable situations for others and personal embarrassment. That, too, is not practical in the real, everyday work world.

One of the more distasteful, regular routines that many ostomists are confronted with is that of emptying the ostomy bag. This procedure puts the ostomist's nose in much closer proximity to his or her waste than any would like, and closer than most any non-ostomist would tolerate. There is a need to pay close attention to what one is doing in the emptying process, or such waste can find its way to many more places than anyone would like. There have been apparatus and techniques for facilitating bag cleaning disclosed in the prior art, which would help increase the nose/waste distance. (See, for example, U.S. Pat. No. 5,470,325 and references cited therein.) However, these have tended to add significant additional cost, and prior art cleaning devices (such as are described in U.S. Pat. Nos. 6,532,971, 5,083,580 and 5,037,408) generally would be cumbersome to make available outside the ostomist's home bathroom and/or add distasteful steps to the ostomist's routine. Some of the smell is associated with the emptying of drainable bags and especially the cleaning of the drainage channel after emptying.

The ostomist in need of deflation is pushed by the above challenges in the direction of interrupting normal activities and finding seclusion to go through the steps indicated above to minimize, and hopefully avoid, discomfort and embarrassment from escaping odors, fluids, and/or solids. Ostomists are left wanting for an ideal system for handling their ostomic environment (that is, the odors, the discharges, the discomfort, the appearance, the inconvenience, and the health issues) to minimize the negatives for their friends, family and associates, while being thankful that the surgery that created their ostomy likely saved their life.

BRIEF SUMMARY OF THE INVENTION

In accordance with the present invention the ostomist is offered processes and systems, including tools, for managing ostomic waste which accommodate a wide range of physical dexterity limits and social situations, while helping to minimize the personal risks to the comfort of others as well as themselves (e.g. to the ostomist's employment security and to social acceptability). The present invention offers significant, added flexibility to ostomists as to how to deal with their very personal, often troubling issues. The ostomy waste management tools processes and systems, including ostomy bags and versatile latent tubes, of this invention provide this flexibility cost effectively and conveniently with little adjustment to the ostomist's routine. In addition, this invention could simplify the manufacturing process for manufacturing ostomy bags that suit a number of differing purposes, while offering the ostomist unprecedented choices. Making flushing cleaner and easier to accomplish accordance with the present invention can result in less high smell time adding further comfort to the ostomist. Bags or pouches in accordance with this invention having latent multiple use tubes (versatile tubes) having ports that accommodate those multiple uses also allow the ostomist to benefit more efficiently and reliably from existing products and previously suggested concepts from others, for example, for de-odorizing flatus gasses.

A BRIEF DESCRIPTION OF THE DRAWINGS

The figures described below depict various preferred aspects in accordance with the subject invention. The figures are for illustration and are not drawn to scale. For example, where walls are sealed together, wide or hatched lines represent the seals. The width of those seals is exaggerated to assist in displaying certain characteristics. Similarly, proportions do not necessarily conform to any commercial ostomy bags. Dimensions have been selected to represent specific features for illustration, while sized and proportioned to fit drawings that will illustrate the inventions discussed. The many different sizes and shapes of commercially available ostomy bags testify to the differences of opinions of skilled artisans in this area. FIGS. 1, 2, 3, 4, 6 and 7 are depicted in the orientation in which they would appear if they were viewed from the front of an ostomy bag wearer (ostomist). Accordingly, even when in partial or cutaway, unless otherwise indicated, their orientation would appear the same way. Viewed in that way, some commercially available bags have arched tops and arched bottoms, while others have arched tops and relatively straight, horizontal bottoms. Still others have narrowed bottoms with discharge openings. Some ostomy bags have relatively straight-line, horizontal tops and arched bottoms. Some appear as ovals, others as rounded corner rectangles or trapezoids. The list goes on. The drawings and descriptions below are intended to illustrate that these same types of bag configuration alternatives are accommodated and benefited by the present invention. Thus, for example, where an upper extremity of a bag is depicted and described below in accordance with the present invention, unless otherwise specifically stated, the upper extremity would provide benefit when used with bottoms of any practical shape. Also, the term "multiple use tube" as used herein includes versatile tubes, that is, tubes have the potential for being used for a number of separate purposes, but not necessarily actually used for multiple purposes. Accordingly, a specific user may use a particular multiple use tube as described hereinbelow for the same purpose continually, while another user may use an identical tube for a different purpose. Yet another user may choose to use an identical tube for two or more purposes. Such tubes all fall within the definition of "multiple use tube" or "versatile tube" as used herein.

FIG. 1 depicts in cutaway outline the internal surface, with sealed perimeter and internal surfaces and unsealed perimeter edges, of the body side-wall of a drainable ostomy bag. The full perimeter of FIG. 1 depicts the frontal outline view of the bag.

FIG. 2 depicts in cutaway outline the internal surface, with sealed perimeter surfaces and unsealed perimeter edge of the body-side wall, of a closed ostomy bag. The full perimeter of FIG. 2 depicts the frontal outline view of the bag.

FIG. 3 depicts in cutaway the internal surface, with sealed surfaces and unsealed edges, of the body-side wall of an upper extremity of an ostomy bag having two latent, multiple use tubes.

FIG. 4 depicts, in cutaway outline the internal surface, with sealed surfaces and unsealed edge of the body-side wall, of the upper extremity of an ostomy bag having a generally straight line top.

FIG. 5A depicts, with sealed perimeter surfaces and unsealed perimeter edges, the upper extremity of the external side of the frontal wall of an arched top ostomy bag having a versatile latent tube and an internal closure mechanism for closing the tube.

FIG. 5B and FIG. 5C depict in top view cutaway the ostomy bag of FIG. 5A illustrating the formed closure mechanism, each with the versatile latent tube in different closed positions.

FIG. 6A depicts in perspective a connecting tube for connecting selected apparatus to an ostomy bag. FIG. 6B depicts in perspective a partial view the upper extremity of an ostomy bag with a straight-line, horizontal top, which has a connecting tube, inserted into its multiple use tube.

FIG. 7 depicts an ostomist's midsection with the ostomist wearing an ostomy bag (the upper extremity of which has a straight line horizontal top) having two versatile tubes, one of which is connected to some tools used by the ostomist to manage waste.

FIGS. 8 (A, B, C, D, E and F) depict some tools for use by the ostomist consistent with the depiction in FIG. 7.

FIG. 8A depicts a cylindrical filter.

FIG. 8B depicts in fragmentary perspective filter material before it is rolled as an interior component of a filter.

FIG. 8C depicts an enlarged view of a latent tube connector.

FIG. 8D depicts a connector having a relatively flat, slender, elliptical-profile.

FIG. 8E depicts an end view of a circular filter rolled from filter cloth.

FIG. 8F depicts in cutaway enlargement the roll layers depicted in FIG. 8E.

FIG. 9 depicts in partial view cutaway enlargement the upper extremity left side (as depicted) of ostomy bag 71 of FIG. 7.

FIG. 10 depicts in frontal perspective partial view a connector linking an ostomy bag versatile tube with a connector to a filter.

FIG. 11A depicts an enlarged view in partial cutaway of a long thin filter connected as a preferred tool depicted in FIG. 10.

FIG. 11B depicts in cutaway an edge view of the filter depicted in FIG. 11A.

FIG. 12A depicts an enlarged adhesive side view in partial cutaway of another long thin filter as a preferred alternative to the filter depicted in FIG. 6A.

FIG. 12B depicts an enlarged view of a series filter connector latent tube.

FIG. 12C depicts a substantially enlarged cutaway edge view of filters depicted in FIG. 12A placed adhesive down on the connector latent tube depicted in FIG. 12B.

FIG. 13A depicts an exaggerated edge view of a long, folded latent fluid conveyance tube.

FIG. 13B depicts a flat frontal view of a latent fluid conveyance tube like that of FIG. 12A.

FIG. 14 depicts a formed fluid conveyance tube that is attachable to latent fluid conveyance tubes depicted in FIG. 13A and FIG. 13B.

FIG. 15 depicts in cutaway an internal view of a bifurcated latent tube.

FIG. 16 depicts a portion of an ostomy bag upper extremity with a versatile tube similar to that illustrated in FIG. 7 but having a firm water delivery tube inserted in the versatile tube. The water delivery tube is connected to a water delivery system.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

FIG. 1 depicts, in cutaway drainable ostomy bag 11 revealing interior surface of the body-side wall 10 of ostomy bag 11 having an arched top. As indicated above, the body-side (or "rear") wall is the wall of the bag that is normally closest to the skin of the ostomist wearing the bag. The exterior of rear wall 10, therefore, is desirably (and typically) covered with a soft textured more skin friendly plastic. Ostomy bag 11 rear wall 10 has a perimeter that is sealed to a mating frontal-side wall and to a partially mating comfort layer on its exterior. The seal is indicated by hatched lines: seal 12, seal 12b, and seal 12c. The entire perimeter of ostomy bag 11 is sealed except for two ports: (1) waste discharge port 14 and (2) versatile tube multipurpose port 16. Port 14 is the opening at the end of waste discharge channel 13. During waste collection in main chamber 17 of ostomy bag 11, (the chamber receiving gaseous, solid and liquid waste from the stoma) channel 13 is closed, for example, using clamps readily available in the market. (See, for example, U.S. Pat. No. 5,125,133.) Channel 13 is opened at times of discharge of waste through port 14 and during cycles of cleaning bag 11 when the bag is drained through channel 13, the fluid exiting out port 14. Port 16 is a transverse or crosscut opening at the end of versatile tube 15. The terms "transverse" and "crosscut" as used herein with respect to tube openings mean openings completely across the tube (or that would result in open end shape profiles, rather than longitudinal openings in the tube walls), but not limited to openings across at right angles to the tube walls. The fact that versatile tube ports which open to the outside of ostomy bag 11 are transverse (or crosscut) openings is important to the tubes' capability to accommodate the insertion of connectors, filters or other ostomy tools described herein. The principle is that the versatile tube can accommodate insertion and support secure connection of tools and thus it can be said that the distal opening of the versatile tube "will support axial flow," more than radial flow, of gas out of the opening, (that is, flow more in the direction of the longitudinal axis of the versatile tube than in the direction of the radius of the tube). Without versatile tube 15 and its chamber 15c, and the baffles associated with it, ostomy bag 11 looks very much like bags that are commercially available. The inclusion of a versatile tube like tube 15 in a new bag designed to include it would, except for initial retooling costs, involve minimal additional manufacturing cost. Yet, that small addition to the structure of the bag, adding a versatile tube, provides substantial benefits to ostomists. This will be discussed more fully below. Stomal aperture 9 represents a commonly used opening in an ostomy bag rear wall through which a normal stoma can protrude, and through which stomal waste is deposited in main chamber 17 of bag 11. Upper extremity 11u of ostomy bag 11 for purposes herein is defined in the context of the bag as worn. Thus, the area above the actual stoma (the "upper extremity of the bag") would usually begin at a level at least about 1 cm (3/8 inch) above the level of the midpoint of an actual rear wall aperture. Similarly, "upper extremity of main chamber 17" would be that portion of the main chamber above a level at least about 1 cm above the level of the midpoint of the rear wall aperture.

Fluid communication between the upper extremity of main chamber 17 and latent chamber 15c of versatile tube 15 is supported through port 7. Versatile tube 15 is sealed on its upper perimeter by a portion of seal 12 and on its lower perimeter by seal 12c. That upper portion of seal 12, together with baffle 19, port 7, seal 12c and distal port 16 define the boundaries of versatile tube 15 chamber 15c. Arched space 12a is an exaggerated depiction to show that seal 12c is not connected to seal 12b except at the ends of seals 12b and 12c proximal port 7. There the two ends meet and form one sidewall of port 7. The port end of baffle 19 forms the other sidewall of port 7. Optional, but desirable, baffles 18, 19 and 191 (sealed to both rear wall 10 and the frontal wall of ostomy bag 11) guide gas through channels leading to and through port 7 and channel 8 to versatile tube 15, while assisting in the prevention of fecal material getting into chamber 15c. Chamber 15c can be closed temporarily anywhere along its length with a simple clip, for example, a small bag clip, a toy hair clip, or even a paper clip (such as a small vinyl coated paper clip or a round plastic paper clip). Closing port 7 (and/or channel 8) temporarily would keep fecal matter from finding its way into chamber 15c of tube 15. Prior to using tube 15, for example, as a vent tube, space in the upper extremity of chamber 17 near port 7 would be cleared of any fecal matter. In the unlikely event solid or liquid fecal material does get into chamber 15c, the ostomist can readily remove it. After first assuring the closure of port 16 and fixing the distal end of tube 15, the ostomist uses his or her left thumb and forefinger to squeeze tube 15 while moving the thumb and finger in the direction away from port 16 and toward port 7. When the material gets to the channel 8 side of baffle 18 the squeezing moves in a downward direction and then toward, and past port 7 so the material passes into the upper extremity of chamber 17, down and away from port 7. Baffles 18 and 19 are shaped to provide both resistance to fecal solids getting into chamber 15c and to facilitate the squeezing out of any fecal matter that does get past port 7 and toward or into chamber 15c.

In a preferred embodiment versatile tube 15 is included in the manufacture of bag 11 (substantially simultaneous) in much the same way as conventional manufacturing handles the manufacture of the narrowed area waste discharge channels analogous to channel 13. That is, tube fifteen is manufactured from the same set of blank plastic sheets (or rolls) as is used for forming main chamber 17 and discharge channel 13. Thus, the front and rear walls of main chamber 17, discharge channel 13, and versatile tube 15 are of the same thickness, texture and flexibility. However, as is the case with some well known commercially available bags the comfort layer that covers the exterior of the rear wall of their main chamber, covers only a small portion of the rear wall of the narrowed discharge channel. In one commercially available bag, for example, the narrowed waste discharge channel area has parallel sealed edges extending in length about 5.5 cm (about 2.2 in.) with about 4.5 cm (about 1.8 in) of that length nearest the exit port having no comfort backing. For reasons discussed below it is helpful to have no comfort covering on at least about 1.2 cm (about 0.5 in.) of the end length of versatile tube 15 nearest exit port 16. Versatile tube 15 can be used for such purposes as: (a) connecting to firm tubing used as connectors or filters; (b) connecting directly to filters; (c) venting of flatus gasses; (d) partly or wholly housing a filter; (e) providing expansion potential to capture gas once the ostomy bag is otherwise at capacity; (f) serving as a conduit to conduct fluid from one location to another; (g) connecting to water sources for flushing waste from an ostomy bag; and (h) inserting odor counteractants or modifiers into the bag. These subjects will be discussed in greater detail in the context of subsequent drawings.

FIG. 2 depicts in cutaway outline the internal surface of body-side wall 20 of ostomy bag 21 which has a rounded-corner rectangular-like perimeter and upper extremity 21u, with sealed perimeter edges (seals 22, 22b and versatile tube 25 lower perimeter seal 22c all represented by hatched lines) and unsealed perimeter edge (port 26). The full perimeter of FIG. 2 depicts the frontal outline view of ostomy bag 21. Ostomy bag 21 depicts a closed ostomy bag, thus having stomal aperture 29 but having neither a waste discharge outlet (corresponding to port 14 of FIG. 1 nor a narrow channel (corresponding to waste discharge channel 13 of FIG. 1). As previously indicated both closed and drainable ostomy bags have been made available in a number of different shapes. For example, both drainable and closed types of bags can be made available with arched profile upper extremities (similar to the upper extremity of main chamber 17 of ostomy bag 11 of FIG. 1) or generally straight profile upper extremities as depicted in the upper extremity of main chamber 27 of FIG. 2 (both as viewed from the front). Versatile tube 25 of ostomy bag 21 comprises latent chamber 25c, which is formed by a portion of seal 22 (on its upper edge and its end proximal channel 23), seal 22c and multipurpose port 26. Space 22a is an exaggerated depiction to show that seal 22c is not connected to seat 22b except at the ends of seals 22b and 22c proximate channel 23. Channel 23 is formed between a portion of seal 22 and the joined ends of seals 22b and 22c distal from port 26. Channel 23 serves as a fluid communication connection of chamber 25c of tube 25 with the upper extremity of chamber 27. The length of versatile tube 25 as compared, for example, to versatile tube 15 of FIG. 1 provides advantages for the ostomist who for example wants to use the tube for housing elongated filter material. Further consideration of such alternatives is discussed below. Ostomy bag 21 could be used for example, in many of the ways indicated: (a) for versatile tube 15 of bag 11 of FIG. 1; and (b) in the discussion of the combinations depicted in FIG. 6B below. The flat top profile upper extremity could be used to advantage with a format that would use other lower bag designs, e.g., drainable bags. The inclusion of the versatile tube in a flat top bag offers significant added options for the ostomist.

FIG. 3 depicts in cutaway the internal surface of rear wall 30 (the body-side wall) of upper extremity 31u of an ostomy bag having main chamber 37 (partially depicted) and two latent multipurpose tubes, tube 33 on the right side (as depicted) and tube 35 on the left side (as depicted). Multipurpose tube 35 is formed by: the bag's frontal (not depicted) and rear walls, seal 38 which separates tube 33 from tube 35; a part of the upper portion of seal 32 at its top edge; multipurpose port 361; and seal 32c (which extends from its distal end at multipurpose port 361 to its proximal end at port 371). Port 371 provides fluid communication between tube chamber 35c and the ostomy bag main chamber 37 (partially depicted). The perimeter of multipurpose tube 33 is formed by: seal 38 which separates tube 33 from tube 35; a part of the upper portion of seal 32 at its top edge; distal port 362; and seal 323 which extends from its distal end at multipurpose port 362 to its proximal end at port 372 which provides fluid communication between tube chamber 33c and the ostomy bag main chamber 37. The proximal end of seal 323 connects at port 372 with the proximal end of seal 322. Along their lengths seal 322 and 323 are separated by space 321 (exaggerated to illustrate the separation). For the ostomist a bag having an upper extremity with two such multipurpose tubes provides benefit when used as a part of an ostomy bag having for the remainder of its perimeter any practical shape, for example, like those currently available commercially. For example, if tube 35 is in use, e.g., housing or connecting to a filter, or connected to another tube (e.g. for venting), tube 35 could be closed near port 371 by attaching a clip across the gap between perimeter seal 32 and perimeter seal 32c while the tube 33 is used as an entry point for a water source to flush the bag. A flushing tool is shown engaged with a similar tube in FIG. 16 and is discussed further below. Another alternative use for a second tube is for the insertion of an odor counteractant. One or more baffles, for example, similar in shape and placement (relative to fluid flow channels) to baffle 191 of ostomy bag 11 of FIG. 1, could be added to the configuration to help minimize solid fecal matter entry into chambers 35c and 33c.

Some ostomists would benefit significantly from the stability advantage provided by separable linkage 32a between seal 32c and seal 32b. The separable linkage allows the ostomist (for example who is using the versatile tube in an application that benefits from stability) to benefit from the linkage, but also allows separation by the ostomist who benefits more from a tube separated for some length back toward channel 371. This provides ostomists additional non-confusing flexibility with how they meet their needs. With the separable seal the ostomist could leave it in place, release it part way, or separate it all the way to the junction of 32b and 32c. Among other justifications for the differing choices as to the length of the separation of the versatile tube from the main chamber perimeter would be: the use the tube is to serve (e.g. venting, filtering etc.); the specific tools intended for use (e.g. filter, conveyance tube, etc.); and the direction the outlet needs to face. For example, if an ostomy belt is worn, the ostomist might like to use a series of filters connected to the ostomy belt (see FIG. 7 and discussion thereof). In that case distal end 361 of tube 35 should point toward the belt. Belts may be positioned differently, relative to the bag upper extremity, for various bags of different manufacture. If relatively short multipurpose tube 35, for example, were to be used in connecting to a tool attached to an ostomy belt that connected high on a wafer, a full release might be required. A release of 20 percent might be appropriate for a connection to a separate filter. That 20 percent is considered to be at least a substantial part of the tube length, especially if the release provided significant benefit to the user. Accordingly, tube 35 may point straight at the belt (in which case the tube end would remain at least partially attached); or tube 35 may need to be angled either up or down (in which case the tube 35 could be separated all the way to the junction of 32b and 32c). So separated tube 35 would have capability substantially identical to tube 33 which, along its perimeter edge 323, is already separated from seal 322 by arched separation 321 except (a) at the juncture of seal 323 with seal 322 proximal port 372, and (b) at the distal end of seal 323 where extremely small line seal 324 helps hold tube 33 in place, e.g. during shipping. The ostomy bag thus depicted (partially) in FIG. 3 includes main bag chamber 37 with upper extremity 31u with two main bag chamber upper perimeter segments 32b and 322 of defined length with an upper perimeter seal along each. This upper extremity also has two multiple use tubes of defined length (35 and 33) and having proximal end openings (371 and 372 respectively) into main bag chamber 37. Openings 371 and 372 provide capability for fluid communication between the tubes and the main bag chamber. Each of the multiple use tubes (versatile tubes) also has a distal end (361 and 362 respectively) and a lower perimeter seal (32c and 323 respectively) proximate an upper perimeter seal (32b and 322 respectively) of main bag chamber 37. The respective upper and lower perimeter seals are proximate reaching from their distal ends to respective openings 371 and 372. The bag upper perimeter seal 32b is firmly connected to tube lower perimeter seal 32c only at their ends proximate port 371 where they form the border of port (opening 371). Similarly, bag upper perimeter seal 322 is firmly connected to tube lower perimeter seal 323 only at their ends proximate port 372, thus forming the border of port (opening) 372. Other than at their juncture at the port borders each of the upper and lower border pairs are less than firmly connected along a significant length (in fact along their entire length) of the upper and lower seals' proximity in the direction of the respective tube's tube distal end. That is, along its entire length (except for the juncture at their ends proximal port 371) perimeter seal 32b is releasably (or separably) attached to seal 32c, whereas seal 322 is unconnected to seal 323 along its length except (a) at their joined ends which form one border of port 372, and (b) at the weak, line seal. For purposes herein releasably or separably connected seals and seals less than firmly connected shall mean a connection that has a clearly defined path of separating as would be necessary to avoid accidental rupture or weakening of vapor tight seals. For example, a clearly defined thinning in a wider than normal seal, a clearly indicated perforating of a sealed area (or between sealed areas), or even a widened seal area (or two closely adjacent seals) with a clearly defined path for separation would fit the definition of "less than firm connection", of "separably connected", and of "releaseably connected". For many applications, arched tubes (e.g. tube 15 of FIG. 1, and tubes 35 and 33 of FIG. 3) can be used in place of straight line tubes (such as tube 25 of FIG. 2) and vice versa. Manufacturing efficiencies can drive choices to one shape or another. Thus, a two tube ostomy bag can have straight-line tubes, for example, as illustrated if FIG. 7 below. It is also important, however, in accordance with one aspect of the present invention that at least one distal port (that is, the distal tube end) be transverse to the tube axial flow (capable of axial gas flow out of the tube opening) to accommodate secure tool insertion.

FIG. 4 depicts in cutaway the internal surface of the rear wall 40 (the body-side wall) of upper extremity 41u of an ostomy bag having a long, substantially horizontal straight-line (as depicted) multipurpose tube 45, which is formed by: frontal wall (not depicted) and body side wall 40; the upper portion of seal 42; distal port 46; and seal 42c which ends at channel 48. Channel 48 provides fluid communication between tube chamber 45c and the ostomy bag main chamber 47 (partially depicted). A bag having a long multipurpose tube would provide benefit to an ostomist, for example, when the tube is used to house a series of removable cylindrical filters, for example as illustrated in FIG. 8A below. Advantageously, baffles 491 and 492 would deflect most fecal solid or liquid that otherwise could enter channel 48. The long versatile tube would also permit facile removal (See discussion on FIG. 3.) should any such matter get into chamber 45c. The length of versatile tube also permits the inclusion of baffles 441 and 442 upstream of normal gaseous flow to further impede the flow of fecal solids that otherwise could touch or even clog the filters. These optional, but advantageous baffles 441 and 442 are ideally anchored at opposing perimeter seals 42 and 42c and leaning somewhat in the upstream direction (back toward channel 48). The separable linkage 42a linking seal 42c with seal 42b provides the flexibility referred to above with respect to separable linkage 32a of FIG. 3. Separable linkage 42a is depicted as extending to the end of seals 42c and 42b. However, in some circumstances it may be appropriate to have the separablilty extend only a substantial distance (e.g. 30 percent of the distance) from the distal end of tube 45. That option exists for other separable linkages in accordance with the present invention. The distance of separation desired would depend, for example, on the total length of the versatile tube and the particular use chosen for the versatile tube. Again, an ostomy bag having for the remainder of its perimeter any practical shape, for example, like those currently commercially available, could benefit from having the upper extremity depicted in FIG. 4.

FIG. 5A depicts upper extremity 51u of the external side of the frontal wall 53 of ostomy bag upper extremity 51u, with sealed perimeter surfaces 52, 52b, 52c and a portion of internal boundary seal 54, together with unsealed perimeter edge, multipurpose port 56 forming the perimeter boundaries of versatile tube 55 which fluidly communicates with main bag chamber 57. A portion of perimeter seal 52 together with internal boundary seal 54 provide boundary of the internal closure mechanism, which further includes slits 59a and 59b. Boundary seals along slits 59a and 59b provide strength for the closure mechanism. Depending on the application (for example, frequency of opening and closing) it could be advantageous to include internal seals on both sides of each slit, extending the full length of the distance between perimeter seal 52 and internal boundary seal 54 to provide additional strength for slit integrity. FIG. 5B depicts the integrally formed closure mechanism of ostomy bag 11 in exaggerated/magnified cutaway showing the path of tube 55, first through slit 59a and then through slit 59b as one way to close tube 55 using the internal closure mechanism. FIG. 5C depicts in exaggerated/magnified cutaway the path of tube 55, first folded (doubled) over and then (the fold is) advanced through slit 59a as another way to close tube 55 using the internal closure mechanism. If desired, the FIG. 5 C alternative is made more secure by inserting; for example, one leg of a soft-ended paper clip 552 (e.g. a vinyl coated paper clip) in the fold after the fold is advanced through slit 59a.

FIG. 6A depicts in perspective generally cylindrical firm connecting tube 62 for connecting selected apparatus to an ostomy bag in accordance with the present invention. Attached to main cylinder 63 of connecting tube 62 near each of its ends (e.g. see proximity of hump 67 to end 69) are circumscribing rounded humps 66 and 67 having a maximum diameter (at the largest diameter of the hump at least about 2.5 mm, about 0.1 inch) greater than the exterior diameter of main cylinder 63 adjacent each hump in the direction of the cylinder toward the other hump. As depicted in perspective in FIG. 6B, connector 62 of FIG. 6A has been inserted in an axial direction (i.e. axially inserted) in versatile tube 65 of ostomy bag 61 of which only upper extremity 61u is depicted (similar to upper extremity 41u of FIG. 4B, except that versatile tube 65 is separated from the main chamber of bag 61 along a major portion of its edge proximal said main bag chamber). End 69 of connecting tube 62 is secured inside versatile tube 65 by elastic band 68 which is placed on the exterior of versatile tube 65, said band 68 circumscribing tube 65 and securing connector 62 end 69 within versatile tube 65. Desirably, the placement of elastic band 68 (around cylinder 63) would be proximal to, but to toward the end-to-end center point of connecting tube 62 from, hump 67. Versatile tube 65 as depicted is closed at its proximal end by placement of clip 64. Closure of versatile tube 65 would be standard procedure when connectio