Pad for use with continent ostomy port

A pad for use with a continent ostomy port includes a body portion having an internal wall defining an aperture appropriately sized to place around a stoma. The body portion is sized and shaped for placement against a user's skin beneath a face plate of an ostomy port and is formed of a material to cushion and protect the skin from contact with the face plate. The body portion has a stepped configuration of at least two distinct levels on a distal surface thereof, including a first level and a second level, the first level having a perimeter sized and shaped to fit within a perimeter of a face plate lip, and the second level extending parallel to the first level and having a perimeter extending beyond the perimeter of the first level, beneath the lip of the plate, to thereby protect the use's skin from friction irritation.

BACKGROUND AND SUMMARY OF THE INVENTION

1. Field of the Invention

The present invention relates to the field of ostomy devices, and, more particularly, to a self-retaining ostomy port which can be inserted into a stoma and secured for long-term placement without the use of adhesives, belts, bandages or revisionary surgical measures, and thus allows the user to be effectively “continent”. The new ostomy port features a low profile and can be repeatedly selectively opened and closed without removal from the stoma, as may be necessary or desired by the individual user, and does not require the constant attachment of an ostomy bag or pouch.

2. Background of the Invention

Surgically formed stomas may be of a variety of types, including, but not limited to, ileostomies, colostomies and urostomies. Although the discussion below will usually describe the invention with reference to the stoma resulting from a colostomy procedure, it is to be understood that the new continent ostomy port can be applied to other types of stomas as well including those interfacing with internal reservoirs. Ostomates, individuals provided with a stoma, have historically been faced with a variety of problems not ordinarily experienced by the general (non-stoma bearing) public. These problems have included seepage of intestinal gas and waste, such as mucous and liquid and solid fecal material from around the site of the stoma. Such seepage not only causes unpleasant and embarrassing odors, but also leads to health problems, such as necrosis of the tissue surrounding the stoma site, creating the additional problems of increased expense and health risks related to further surgery to relocate or modify the existing stoma.

Traditional ostomies generally require the patient to have a bag or container of some sort attached to the ostomy for constant collection of body waste. Necessarily, the bag will become heavy and cumbersome as it automatically fills with body waste over time, and the user is faced with the risk of spillage from the bag, while in place, as well as during the process of emptying the bag's contents. Further, the material of the bag (as well as some adhesives) can cause allergic reactions in some users, and the bag material also makes bothersome noises during movement as the bag rubs against the user's clothing. For many ostomates, the bulk of the bag beneath clothing is also a problem. All these aspects of having an ostomy can deter social activities of all types, and especially any which are relatively more physical in nature. Frequently isolation and depression result.

The known art has made a variety of attempts to address these problems, without complete success. Although the majority of ostomates use bags to manage the ostomy excretions, a number of barrier devices have been developed which essentially plug or seal the stoma until the user is ready to purge, with resultant problems further discussed hereafter, which were not clinically viable, and in many cases, have necessitated revisionary surgery. By contrast, the new continent ostomy port is just that, a port, not a sealed closure or plug. Rather, constant but gradual, filtered, controlled venting of intestinal gas is provided with the new port, relieving the user from discomfort of internal pressure build-up, and also permitting quick and facile access for irrigation and purging the ostomy without removing the port from the stoma.

One such previous device included strong magnets in the external portion of the closure and magnets surgically sealed within the user's skin for transdermal connection of the ostomy plug-type closure. Leakage and skin irritation can result from use of such a device. Alternatively, if the plug is too tight, an extremely uncomfortable, even painful, build-up of intestinal gasses can occur. Known stoma closure or plugging systems also suffer, inter alia, from the problem of not being adjustable in response to daily variations in the user's body, as well as variations between user's tissues; i.e., they are not “bioresponsive”, so that in order to implant the device in a manner sufficient to maintain a fluid-tight seal, the tissue around the stoma is severely pinched, obstructing blood flow. The loss of blood eventually causes tissue death and results in further surgery being required to remove the damaged tissue and to repair the stoma. Some other devices are difficult to clean and therefore permit waste to accumulate in tissue crevices, resulting in unpleasant odors and tissue irritation. All of these shortcomings of the art are addressed by the various embodiments of the new continent ostomy port.

When a stoma is tightly sealed for an extended period, such as a matter of hours, there can be a painful build-up of intestinal gasses, which are explosively released as a bolus when the stoma seal is breached. Previous attempts to filter such gasses have met with limited success, as the filter device could permit leakage to occur. Known devices also do not take into account adjustment or adaptability to account for pouch disturbances, which occur due to internal or external pressure changes. The new continent ostomy port has a number of structural features that permit it to overcome these and other disadvantages of the known art.

SUMMARY OF THE INVENTION

The new continent ostomy port described herein can be non-surgically inserted into a new stoma or non-surgically retrofit into a patient who has an existing ostomy, and provides the ostomate with greater freedom of movement without the untoward results often associated with use of conventional devices. The new ostomy port permits long-term (at least 30 days) port access and eliminates the need to continuously wear an ostomy bag and/or the need for lengthy daily irrigation procedures. This long-term access port prevents the leakage sometimes associated with the use of irrigation devices and colostomy bags because the connection between such ostomy accessories and the patient is via the new locking, sealing port. Conventionally such accessories are connected directly to the stoma site by gluing or belts, thus permitting leakage because a complete seal at the site of connection is not always possible.

In view of the various short-comings of the known art, it is among the several goals and advantages of the present invention to provide a continent ostomy port (“COP”) i.e. a port which permits the ostomate to be effectively continent, which virtually eliminates leakage of liquid and solid waste from the stoma, and which continuously controls gaseous odors by permitting gradual filtered release of intestinal gasses. The new device, having the features mentioned, is adapted to be selectively connected to a pouch or tubes, as may be necessary from time to time to dispose of waste and to irrigate the intestine for cleanliness and health, while also being capable of being tightly capped for substantial periods of time, even hours, for example, to permit the user to engage in normal physical activities and to function in a wide variety of social settings without fear of accident or embarrassment.

Because an external pouch is not required to be worn, and there are no belts, adhesives or other additional devices required to hold the new COP securely in place, the user has the freedom to wear tighter or more revealing clothing than would otherwise be possible, and there is no concern of noises, such as “crinkling” sounds, inherent with the usual plastic ostomy bags. The user thus is provided with a generally improved quality of life, including enhanced body image, increased confidence and potential sexuality, and has available a wider potential range of movement, enhancing possible athletic activities as well, without the psychological stress of concerns with leakage and odor. The new device is, however, adapted for selective use with new, specially designed, drain tubes, irrigation sets and optionally biodegradable, disposable waste bags, as well as with known styles of drainage tubes. In addition, the device works with known internal surgically created reservoirs, such as those generally known as Kock and Indiana-type pouches. It is also suitable for use with surgically formed urinary and bowel ostomies, as well as with cecostomies, and gastrostomies, and for decompression and irrigation purposes.

It is further among the advantages of the new invention, having the features indicated, that because of the presence of the catheter portion of the new device in the stoma, there is reduced likelihood of stoma prolapse to the outside of the abdomen, as well as reduced incidence of stoma retraction into the abdomen, and reduced likelihood of strictures in the stoma. There is the further advantage that there is no peristomal skin trauma from heavy colostomy bags and irritating adhesives, and the expense and bother inherent with use of pastes, glues, tapes and belts ordinarily required to keep a conventional stoma and pouch in proper placement is virtually eliminated. The skin to port seal developed in use of the continent ostomy port described herein is not impacted by cutaneous mucous discharge or topographical changes of the user's body due to weight gain, weight loss or aging, for example. An improved seal and compatibility with irregularly shaped or contoured stomas is readily accomplished with the new COP as compared with the art. Such improved sealing is seen even with use of the new device in ostomate patients who are elderly or obese, with soft or flaccid abdomens.

The indwelling nature of the new COP also has advantages for use in neonates or small children, because the neonate's skin is especially sensitive to the adhesives conventionally used for attaching a bag or sealing a stoma. The neonate is also well served by the lack of necessity for the constant presence of a colostomy pouch, because of the sheer bulk of the pouch that may overwhelm the tiny infant, literally inhibiting movement. The indwelling nature of the new COP is also ideal for ostomates who are undergoing skin-grafting, providing reduction in the otherwise high incidences of peristomal hernation and/or necrotizing enterocolitis (“NEC”) seen in such individuals when fitted with conventional stoma pouch devices, because of the difficulties caused by the stoma environment, a surgical wound formed in the patient's abdominal muscle and the stapled skin over such an opening.

Thus, in furtherance of the above-mentioned goals and advantages, the present invention is, briefly, a continent ostomy port device having a generally planar face plate defining a selectively sealable aperture which is formed through and is alignable with the opening of a stoma formed in the body of a user of the device when the generally planar face plate of the device is disposed substantially parallel to the body wall of the user, over the site of the stoma, to thereby provide access to the inside of the stoma. A closure portion is connected to the generally planar face plate adjacent to the aperture and is adapted to permit selective and repeatable covering and uncovering of the aperture in the generally planar face plate. A catheter portion of the device has a first end and a second end, the first end being connected to and extending from one side of the face plate. The catheter portion extends proximally and the second end of the catheter portion is disposed interior of the user's body, within the ostomy site when the port device is in normal use position. The catheter portion has a continuous and generally cylindrical exterior side wall, and a continuous, generally cylindrical interior side wall defining a major lumen, which extends continuously from the aperture in the generally planar face plate to the second end of the catheter portion. The catheter portion is sized and shaped appropriately for non-surgical insertion through a stoma to a sufficient distance that the presence of the catheter portion within the stoma provides a physical barrier which reduces the incidence of stoma prolapse, without the use of extraneous, externally applied materials or additional surgery.

The invention further includes, briefly, a removable cartridge that is sized and shaped to fit snugly and slideably within the major lumen of the catheter portion of the device so as to be liquid-tight and to thereby prevent inadvertent escape of body waste material from the stoma through the device when the cartridge is in place, so that the user is not required to wear an ostomy bag. and to further thereby clean the interior side wall of the catheter portion as the cartridge is pressed into the major lumen of the catheter.

The invention also includes, briefly, a selectively operable anti-reflux valve that is attached to the second end of the catheter portion, to thereby permit blockage of the major lumen of the catheter portion by activation of the anti-reflux valve when it is desired to prevent escape of body waste through the port device, and to permit passage of fluid or solid material through the port device when the anti-reflux valve is deactivated.

The invention also includes, briefly, retaining structure that is connected to the catheter, and which is non-surgically, snugly fittable into the stoma, and thereby causes the port device to be self-retaining in a normal use position within a stoma of the user, without the need for special surgery and extraneous, external fixation materials such as tape, belts, and adhesives.

The invention is further, briefly, a pad for use with a continent ostomy port includes a body portion defining an aperture appropriately sized to place around the catheter of a continent ostomy port. The body portion of the pad is sized and shaped for placement against a user's skin beneath a face plate of the ostomy port. The pad is formed of a soft, flexible material to thereby cushion and protect a user's skin from contact with the ostomy port face plate, wherein the pad body portion has a distal surface which is domed and provided with a central indented region to thereby accommodate the distal portions of the continent ostomy port.

These and other advantageous features of the present invention will be in part apparent and in part pointed out herein below.

Throughout the drawings like parts are indicated by like element numbers.

DESCRIPTION OF PRACTICAL EMBODIMENTS

With reference to the drawings, and particularly,FIGS. 1,2,5,6,17and22, element number10generally designates a self-retaining continent ostomy port device (“COP”) constructed in accordance with and embodying the present invention. The new ostomy device10is composed of a stomal disk or face plate12from one substantially planar surface of which there extends a catheter portion, generally designated14, for indwelling penetration of the stoma of the user, the “ostomate”, and non-surgical insertion into the intestine, or other body organ which has been subjected to an ostomy procedure.

A closure portion, generally designated18, permits selective, openable covering of the distally disposed opening of the catheter through the stoma plate12, and an internally disposed bolster or retention device, generally designated16, maintains COP10in the necessary, implanted, operative position without the use of revisionary surgery or extraneous, externally applied materials such as belts, or adhesives. Bolster16may take a variety of forms, several embodiments of which will be described hereafter with reference to the drawings. All portions of COP10are formed of pliable, biocompatable materials, such as a sterilizable thermoplastic of known variety, such as polyurethane, for example.

Throughout this discussion the terms “proximal” and “distal” are used in the conventional medical manner; i.e., “distal” meaning farthest from the center of the body, and “proximal” being in the opposite direction, and are used in relation to the position of the claimed structure when new ostomy port10or various embodiments thereof are in operative position implanted in a stoma, as illustrated (as examples only) inFIGS. 11,19,21–21E, and,27. Thus, “proximal” and “proximally disposed” are used in reference to the tip of catheter14, which is inserted into the stoma, and the terms “distal” and “distally disposed” are used to indicate the opposite end of the catheter, at which opposite end there is connected, transversely to the axis of the catheter, the stoma face plate12. As will be clear to one skilled in the art, after review of the following description, the new device10can be initially sized for an individual user and placed or “implanted” very easily in a clinic or office by a trained medical professional. Subsequent replacement ports10, or parts thereof, can be inserted at home by the user (after minimal instruction), or by other trained individuals in alternate care settings.

The stomal disk or face plate12has a smooth perimeter13, and is preferably elliptical, or oval, as shown, so as to fit more comfortably between horizontal skin folds. However, the face plate may take other shapes which may facilitate this fit or otherwise conform comfortably to the user's body, as long as there are no sharp corners or other irregularities that could be irritating to the wearer's skin, or catch on clothing. The generally planar extent of body22of disk12is sufficiently large to clear the stoma site circumferentially. Perimeter13terminates in a smooth lip20, which preferably extends contiguously and proximally from perimeter13of disk12, when COP10is in operative position, so as to entirely circumvent the exposed outer edge of the stoma.

FIGS. 1 and 2, for example, illustrate closure member18in an open position, andFIG. 3shows the same structure in a closed position. Closure member18is preferably formed integrally with plate12, but could be formed and applied separately to close the open distal end of catheter14. As seen inFIG. 1, for example, the body of plate22defines an aperture24, which is in open communication with a waste management lumen26of the catheter portion14. Aperture24is preferably at the approximate center of the upper surface of the generally planar body22of plate12. However, if necessary, or more comfortable for certain ostomates, aperture24could be offset from the center of plate12.

Closure member18includes a cap portion28which is preferably flat, with an annular side wall, as shown, but may have a different shape, as long as the shape is appropriate for selectively openable sealing of aperture24. A small vent hole30is formed entirely through the thickness of cap28to permit gradual release of intestinal gasses through port10; even when cap28is closed. An elongated flexible retaining member32is connected at one of its ends to cap28, and at an opposite end to a collar portion34of face plate12, which collar portion34, as shown, completely surrounds aperture24. Paired detent bars36are formed on the inside of collar portion34, preferably parallel to each other. An annular neck portion38extends from one surface of cap portion28circumferentially in relation to vent hole30. Neck portion38is sized to be slideably, snugly received within collar portion34, so as to be retained liquid tight therein.

In the embodiment shown inFIG. 1paired detent grooves40are formed on opposite sides of neck portion38to engage detent bars36and thereby retain closure member18in the port sealing position illustrated inFIG. 3. Other possible structural configurations can certainly be conceived which will suffice for facile retention of a closure member over the opening of lumen26. Such other configurations for a closure member are considered to be in keeping with the invention if other aspects of the invention are met.

It is also desirable to provide an integral finger grip42on cap portion28, and particularly preferred that the grip42have ridges or other structure and be of sufficient size to enhance gripping, to enable an ostomate to readily and securely grip and pull it to remove cap portion28from the seated or closed position shown inFIG. 3to the open position shown inFIGS. 1 and 2. This feature of course is a convenience and port10will function even lacking grip42altogether, or if such grip is modified in any of a number of ways which will be readily apparent to the skilled artisan.

Although the described closure structure is preferred, other useful closure means can certainly be conceived which will suffice. For example, the detent mechanism can extend entirely around the neck and corresponding bolster members, as illustrated schematically in the variations of an alternative embodiment, generally designated100, shown inFIGS. 11–16, for example. In this embodiment an annular groove140is formed around the inside wall at the distal end of catheter114. An annular ridge136on neck138of cap portion128is correspondingly sized to snap-fit into ring140in secure, leak-free, detenting fashion. Alternatively, the mechanism shown inFIG. 1can be modified to use only one, or more than two sets of interacting, detenting bars and grooves. Similarly, the shape and structure of closure member18can be satisfactorily altered, as long as there is a mechanism provided to prevent inadvertent detachment and/or loss of the cap portion of the closure, so that the new continent ostomy port can always be selectively “closed”.

Catheter member14is preferably generally tube-shaped and usually extends substantially perpendicularly to the plane of plate12. However, catheter14is shaped and sized in diameter and length appropriately for the particular type of stoma for which the new COP is intended, it being understood that the new port is suitable and readily adapted for various types of ostomies and to any size of ostomate, as discussed in the

Background portion above. Ordinarily the outside diameter of catheter member14will not be so large that the port device10cannot be gently manually turned or “twirled” within its seat in the stoma. The cylindrical, inner side wall44of catheter14defines a “major” lumen26and is most commonly straight and smooth to facilitate insertion and removal of a deodorizing cartridge or tampon70,70′ (described further below) and to deter accumulation of particles of waste.

The exterior side wall of catheter14is also preferably cylindrical, smooth and straight. However, there certainly may be uses of port10conceived for which an altered shape of the catheter portion may be beneficial, without such altered shapes being outside of the scope of the invention.

In the embodiment ofFIG. 2, COP10, there are formed longitudinally within the material of catheter14, between walls44,46one or more elongated air ducts or minor lumen, such as those indicated at48,50, for example. How many such lumen are provided the exact structure of which will vary depending upon the type of bolster provided on a particular COP, as well as with the type of anti-reflux valve (“ARV”) used, if any.

Lumen48exits proximally through the exterior side wall46of catheter14, and is in fluid communication with bolster portion16. Whereas lumen50exits proximally through the interior side wall of catheter14, to open into the larger, major lumen26, and/or is operatively connected to an anti-reflux valve56. The distal ends of lumens48,50both exit through plate12, as illustrated, or in equivalent manner. The exterior access to lumen48is via a “breather” port52, which provides a pressure relief mechanism for retention bolster16. Port52is preferably provided with a filter or screening membrane (not shown) in such manner as to be open to the flow of gasses, but not to liquid. Exterior access to duct50is via inflation/deflation valve54, which provides a means of operating anti-reflux valve56, as discussed further hereafter.

By contrast, in COP100, the embodiment illustrated inFIGS. 11–14and18–20, there is seen only one such air lumen50, connected from access valve54to the anti-reflux valve56′, discussed further hereafter.

FIG. 4illustrates a moisture seal or pad58(enlarged), which is preferably disposed in use between the back side of plate body22, and the ostomate's body, covering the skin immediately around the stoma and serving to keep the stoma moist, as is necessary to protect the sensitive peristomal skin and stoma area. Pad58also provides some cushioning between the skin and lip20of plate12and is preferably formed of an open-celled foam into an oval shape with two substantially flat, stepped levels, although a single thick layer would suffice. A central aperture60is defined by a generally annular inside wall61and is accessible via slit62, which permits the user to gently open the pad for facile placement to and removal from an operative position, entirely around the perimeter of the stoma T′, as indicated in the sectional view ofFIG. 11. It is expected that various sizes of pad58will be provided, depending, among other things, upon the user's size. For example, pad58can be made with the aperture60increasing in ¼ inch increments, from approximately 1 inch to about 2¾ inches.

A first level64of pad58is formed with a perimeter slightly smaller than, but having the same general shape as the perimeter13of stoma face plate12, so as to be readily fitted within the perimeter outlined by face plate lip20, and to lie substantially flat and parallel to and between plate12and the user's skin.FIG. 5illustrates the hollowed-out, proximally disposed side of stoma plate12(reduced), within which the first level64of pad58fits. With pad58so positioned, a second level66extends parallel to first (distal) level64, and the perimeter of second level66extends somewhat beyond the first level, beneath lip20of plate12, as indicated by broken lines inFIG. 6, to protect the user's skin from friction irritation.

The shape of the perimeter of second (proximal) level66of pad58may be generally oval, round, or otherwise, as however is economical and convenient to manufacture and comfortable to use, and which is functional as described with regard to the shape of the particular form of port10. Likewise, if plate12is not substantially flat, but instead takes some other form, such as being arched, domed, or whatever suits the particular clinical circumstances, then pad58can be modified accordingly to fit beneath such modified plate shape. Thus, pad58provides a moisture barrier, which prevents the natural stomal secretions from drying, yet, as explained below, simultaneously serves to keep the skin around the stoma site dry. If desired, pad58also provides a handy means of medicating the stoma and the skin directly adjacent to the stoma, by simply applying medicated ointment, lotion, or the like to the proximally directed flat surface and annular wall61of pad58, just prior to positioning the pad between the stoma and stoma plate12.

Pad58is intended to be disposable, for maximum sanitary usage, and is designed to be inexpensive and simple to use, to encourage the user to change the pad on at least a daily basis. However, it is conceivable that pad58could be formed of material which is suitable for repeated washing and drying prior to reuse. It is further conceived that pad58will be formed of material that wicks moisture away from the skin surface, toward the face plate of device10, to reduce fungal growth or other skin irritants. The outer, or distally disposed surface of pad58, however, may be coated with a thin, liquid impermeable skin or membrane which will trap such wicked moisture within the pad, so as to prevent the user's clothes from becoming wet at the site of the stoma. If desired, or necessary the liquid impermeable skin may be of a type that is permeable to air, to permit the pad area to “breathe”. To further enhance the flow of air to the skin around the stoma, the generally flat surface of face plate12can be provided with formed vent holes, not shown.

The inside wall61of pad58may also be provided with such a skin to prevent the stomal secretions from being absorbed into the pad. Depending upon the individual ostomate's personal conditions, it may be desired to have the pad coated on the distal surface, allowing skin moisture to be absorbed into the pad, and permitting such pad absorbed liquid to flow out of wall61, but not out of the distal surface of the pad. In this manner absorbed body moisture is retained in pad58to keep the stoma from becoming overly dry. If desired, a layer of removable adhesive may be applied to the distally disposed side of pad58, to maintain the pad in its desired position in relation to face plate12.

Returning toFIG. 2there is illustrated in longitudinal section, and partially broken away, inflated, one practical embodiment of anti-reflux valve56, previously mentioned.

FIG. 2Aillustrates in transverse section the semi-circular notch68, in the proximal end of catheter14, into which balloon valve56collapses when not activated. This embodiment is merely a repeatedly inflatable and deflatable cylindrical balloon structure that collapses upon deflation into a seat or depressed area68of lumen26of catheter14, preferably but not necessarily at the extreme proximal end thereof, as shown. Anti-reflux valve56is in fluid communication with and is connected by lumen50to an inflation/deflation valve54(indicated schematically inFIG. 2), located on the outside or distal surface22of stoma plate12. When activated, or fully inflated, ARV56blocks the proximal opening of lumen26to prevent inadvertent passage of intestinal contents from port10. Typically, with the new COP, because of the presence of a deodorizing, filtration cartridge (to be described) in lumen26, ARV56is in the non-activated, deflated, position, inflation (activation) only being necessary during certain hygiene procedures, as explained below. Thus, contrary to ARVs currently used in long-term medical devices, the new COP is capable of much longer wear without material fatigue or other break-down.

A variety of suitable structures are conceivable for purposes of providing an anti-reflux mechanism and the structure for permitting selective activation of the anti-reflux mechanism. In the embodiment shown inFIG. 2, inflation/deflation valve54is a schematic representation of a known Halkey-Roberts valve. By a such mechanism, or equivalents thereto, the user is able to selectively introduce air or other fluid into valve54via lumen50, thereby inflating the valve balloon portion and blocking the proximal end of catheter14so that body waste does not inadvertently escape during certain necessary hygienic procedures, as further explained below. Likewise, the user can selectively withdraw fluid from valve56, causing the previously inflated valve to collapse and let gasses or body waste pass into the lumen of catheter14.

An alternative, spherical shape for the balloon/anti-reflux valve structure56′ is shown schematically in the second embodiment, port100, as shown inFIGS. 12 and 15. In each case, inflation via introduction of air or other fluid through a small lumen is a suitable method for activating the valve to close off the proximal end of lumen26. The above anti-reflux valve structures are offered by way of illustration only and are not intended to be limiting, as a variety of medical valve devices, both known and yet to be conceived, are expected to be suitable for use in the new continent ostomy port device, of either embodiment shown, or other reasonable variations thereof. Of course, the two anti-reflux valves illustrated and described herein in relation to port devices10,100can be interchanged with respect to the port devices.

FIGS. 9,10and11illustrate two of a number of practical constructions of an important aspect of the new COP10,100. Cartridge70, shown inFIG. 9, consists of an elongated tampon portion72and a cap-like end piece74. Tampon portion72may be formed of a biodegradable fibrous material, such as cotton fibers, for example, but alternatively, and preferably, is formed of a synthetic material, such as polyurethane, or a semi-rigid, breathable, closed-cell, moisture impervious foam. Cartridge70is preferably disposable, on at least a daily basis, and thus is formed at least in part of an economical substance, to encourage the necessary changes. However, cartridge70can also be made satisfactorily of materials which are suitable for washing and reuse, if desired, as long as the material is breathable, to permit passage of intestinal gasses therethrough, and not so readily biodegradable that it will not withstand operative placement in the new COP for an extended period, on the order of at least a day, or other normal wearing period.

Cartridge70is necessarily sized in diameter and length to fit slidingly and snugly coaxially within the inside cylindrical wall44of catheter14, effectively blocking lumen26from the passage of solid and liquid wastes. Such snug sizing also provides cartridge70with a key function as part of the COP device, in that it permits cartridge70to act as a “squeegee”, scraping clean the cylindrical inside wall of the catheter each time a new or fresh cartridge is placed into the catheter. This cleansing action of the cartridge is a feature not found in the known art. Further, the substantially constant presence of the cartridge within the catheter lumen prevents build up and encrusting of fecal material on the inside wall of the catheter. Thus, with known ostomy closures of the plug variety more effort is required to maintain the stoma area in a hygienic state.

Tampon portion72of cartridge70is especially preferably provided with an odor-absorbing or odor-neutralizing substance, such as activated charcoal, zinc, sodium bicarbonate, or other such known substances, so that cartridge70also provides a deodorizing function, as well as gas flow control and hygiene functions. In addition to the substances mentioned above, other odor absorbing compounds, including new ones, yet to be developed likely will also be useful, as long as they are safe for such intended use in humans. The deodorizing chemical used in cartridge70may be mixed throughout or impregnated into the material of the cartridge. Alternatively, as illustrated inFIG. 9A, the deodorizing chemical may be provided in the form of a pellet, or tablet73, or other solid shape, disposed between the distal end of tampon72and end piece74, or at some other convenient and useful point between the anti-reflux valve and closure portion18.

The end piece74of cartridge70is formed of plastic, or other sufficiently durable, biocompatible material. A collapsible finger grip, such as that indicated at76, for example, enhances gripping and removal of cartridge70when it is necessary to irrigate or drain the ostomy. Vent openings, such as that indicated at 78, or the like, are provided in cap74, particularly if the material of which end piece74is formed is impervious to fluids. This permits the previously discussed gradual release of intestinal gasses when ARV56is deactivated (open) and cartridge70is in place in catheter14(as indicated inFIG. 2, in phantom, for example), even when COP closure member18is in the normal-use (closed) position. The diameter of end piece74(if any) is desirably greater than that of tampon72, and thus is stopped from sliding too far into lumen26by the cap portion encountering and resting against a narrow, internal, annular shoulder35at the distal end of catheter14.

FIGS. 10,11,16, and19, as well as21A and21B show an alternate structure for the cartridge, indicated at70′, shown inFIG. 11inserted into operative position in the second described embodiment of the new COP100. Cartridge70′, and particularly the tampon portion72′ is shown somewhat reduced in diameter in the figures, for clarity. However, it is to be understood that to function optimally tampon portion72′, like tampon72has a diameter sized to fit snugly but slideably within the lumen of the corresponding COP catheter portion. The described snug, slideable fit is necessary to prevent leakage around the tampon, as well as to permit the tampon to serve the additional function of scraping or “squeegying” the internal cylindrical side wall of the catheter as the tampon is removed and replaced, preventing build-up of fecal material within the catheter.

As in the first embodiment, cartridge70′ also has an elongated cylindrical body or tampon72′, but includes a central longitudinal core71of deodorizing material, instead of the deodorizing substance being mixed throughout or impregnating the tampon material.

In this second cartridge example, end piece74′ is effectively merely a continuation of the tampon per se with an elongated, flexible filamentous member76′ connected for improved handling, and an annular ridge79extending outwardly, preferably entirely around the cartridge end74′, to act as a detenting mechanism, engaging an annular groove81within the distally directed end of alternative COP device100, as illustrated inFIG. 11. This construction provides the user with a palpable “stop” point to help prevent accidental over-insertion.

Clearly, as with other aspects of the new continent ostomy port, various features of the two cartridge examples70,70′ could be interchanged as desired, depending upon the embodiment of the COP chosen, or as required, depending upon factors particular to the individual user's situation. For example, cartridge70′ could be provided with a modification (not shown) of end piece or cap member74, wherein an annular detenting ridge is provided on the cap member, rather than on distal end of the tampon per se. Other useful alterations in the deodorizing filtration tampon of the new COP will likely be apparent to the skilled artisan.

FIG. 1illustrates one of a variety of potential forms for an internal retention mechanism or “bolster”, generally designated16, as conceived in the present invention. Among the varieties of bioresponsive retention mechanisms conceived for maintaining COP device10,100in a comfortable, safe operative position are a number of configurations of foam “sleeves” or “cuffs”, illustrated inFIGS. 1, and11–16, and discussed hereafter, a thermo-sensitive wire-form variety illustrated inFIG. 17, and an obturatable variety illustrated schematically inFIGS. 18–20and discussed hereafter. All of such bolsters are in keeping with the goals of the present invention and provide the advantage that the new continent ostomy port can be held in place comfortably and reliably, without leakage and skin abrasion or other tissue irritation, or necrosis, all without the use of belts, glues, adhesives, and without any other body external mechanisms or surgery. Thus, the new COP relieves the previous problematic causes of skin abrasion in ostomates, the chronic compression of tissue and related vasculature.

In each case, the bolster holds the COP in operative position by pressure placed by the bolster, radially from the longitudinal axis of catheter portion14,114against the tissue generally designated T (of which the stoma is formed); e.g. the instestinal wall proximal to the stoma site. Thus, the internal tissue is gently pressed outwardly the bolster in what is effectively an entirely internal “press-fit” or “friction fit” of the bolster against the tissue. This operative structural fit of one style of bolster316is illustrated for example, inFIG. 11, and discussed further hereafter. Another example is shown inFIG. 19, with reference to bolster embodiment616.

It is to be understood that the retention bolster styles of the new COP are referred to as “bioresponsive” because they perform the above-described reliable and secure site retention function without exerting damaging, excessive pressure against the surrounding tissue. It is necessary that the internal bolster does not dilate the bowel wall to such an extent that the vasculature is crimped or pinched. Excessive radial pressure to the lining of the bowel or other organ over any substantial period of time causes ischema and/or bowel necrosis.

It is considered normal in non-ostomates for the bowel wall and any other hollow organ to become routinely squeezed at times, due to a spike in the pressure exerted by nearby, overlying or adjacent organs and musculature. In the case of an ostomate with an indwelling COP device, this may happen during exercise, heavy lifting, sexual activity or even by merely coughing. When the stoma is pulled through a surgically created defect in the rectus abdominus muscles, any flexing of these muscles can also cause change in the internal pressure on the bowel wall. Accordingly, an internal retention bolster on a continent ostomy port, which is to be implanted for an extensive period of time, must be bioresponsive in order to accommodate such pressure changes by correspondingly changing and to thereby avoid tissue damage. The bolster must be dynamic in nature, in order to routinely adjust by automatically collapsing and re-expanding, depending upon the needs and position of the body at a given time. The various embodiments of the bolster portion of the new COP10,100readily meet this challenge in a manner never before accomplished by the known art.

For clarity of the invention and simplicity of this discussion, the new COP device will be referred to by element number10, the embodiment with closure portion18style, and100, the embodiments with closure portion118style. However, it is to be understood that the retention bolster portion will vary among the different views and may conceivably be interchanged among the various practical embodiments of COP10,100, without altering the scope of the invention.

Further, the new COP generally; i.e. the plate and catheter portions may vary; i.e., in some views being schematically simplified, and not all elements will be shown in all views, which views are provided for illustrating the various forms of bolsters or other optional features and/or interchangeable features of the new COP. The various bolsters, described hereafter, are indicated as16,116,216,316and so on. It is to be further understood that the bolster portion is a preferred aspect of the new COP; and is preferably, but not absolutely necessarily, bioresponsive. Rather, the combination of the described face plate and catheter portions, alone (and especially in combination with the described odor and waste control cartridge), is considered to be new, useful and non-obvious.

FIGS. 1–3, illustrate retention bolster16which is formed as a spongy, foam-filled cuff or sleeve which entirely surrounds and is fixed to the cylindrical outer side wall of catheter14, toward the proximal end thereof, spacedly from the position of face plate12, so that there is comfortable room remaining, a matter of about three cm to about 12 cm along the length of catheter14, for receiving the surrounding stoma tissue. This preferred free catheter length also applies to the second embodiment, COP100, for example as indicated inFIG. 19, wherein the stoma tissue beneath the face place112is indicated at T′.

InFIGS. 1 and 2bolster16is shown in a pre-distended or expanded, operative shape. It is conceivable that bolster16may be implanted with this shape inherent. Alternatively and most commonly, bolster16, as implanted, will have the shape shown inFIG. 3, a thin, flat sleeve, which is obtained from the normal bell-shape shown inFIG. 2by pulling (e.g. by syringe) or squeezing (e.g. manually) air from the bolster.

Once implanted, ordinarily using a tool such as the cone-tipped obturating tool80shown inFIG. 3, the bolster swells, simply due to atmospheric pressure, returning to the original operative bell-shape shown inFIGS. 1 and 2. This selectively changeable expandable feature applies to all of the foam style bolsters described herein, and is due, in part to a thin casing preferably provided entirely over the outer surface of the foam bolster. Such casing, if any, may be formed, for example, of polyurethane which is not permeable to air, and thus will permit the user to selectively collapse the bolster by applying negative pressure via valve52. Alternatively, but less likely, the casing or skin17of the foam type bolsters may be formed of cellulose, for example, of other material which is designed to break down on extended exposure to moisture, as within the stoma site, so that the expanded bolster shape will be maintained. Further, new “foams” are available and in further development, which will expand to a pre-designated shape, or to fill the shape, whatever it may be, of the cavity or area in which the foam is placed. Thus, it is conceived that the foam bolster portion COP10,100will be pre-formed to expand to a specific shape that accommodates the blood vessel and/or muscle locations within the intestine in which the COP is implanted, for example.

A variation of the bell-shaped bolster is indicated inFIGS. 5 and 6at element number116.FIG. 13shows a variation of the foam style internal retention bolster, indicated at216and referred to as the shark-fin style, due to the appearance in section of the multiple arcuate foam “rings” which are fixed co-axially to the outer side wall of catheter14. Although it is preferred to have at least two and preferably three such foam rings, only one bolster ring of this style will suffice for some situations, depending upon the type of ostomy and the patient's particulars. This bolster style is merely one example of such a bolster which can be pre-shaped and then implanted in such manner that expanded bolster portions fit snugly between the transverse, circular muscular rings within the intestine, to thereby secure the COP in a manner which is reliable, comfortable and bioresponsive.

FIGS. 13 and 14illustrate foam bolster style316, which is essentially a truncated cone-shape of the same material previously described, with the wide portion of the cone being disposed proximally. This style begins, pre-insertion, with a shape more or less like the foam layer shown inFIG. 12, coating the proximal portion of the exterior cylindrical side wall of catheter114. Of course the foam layer316may be rougher or smoother, thicker or thinner, and of uniform thickness along the length thereof, or non-uniform, depending upon the specific material used and the final, operative bolster shape desired.

FIGS. 15 and 16illustrate foam bolster style416, which is formed as one or more doughnut shapes, or semicircles when viewed in cross section, surrounding catheter14. As with the bolster version216ofFIG. 13, while one such doughnut shaped bolster portion may suffice, it is ordinarily preferred to use more than one, to ensure a secure fit. Which of the above-described foam bolster shapes, or of the following further bolster designs, is selected will vary depending upon the patient and the type of ostomy. It is to be understood that the above constructions, and those which follow are intended merely as useful examples and the invention is not to be considered to be limited thereto, as other equally useful shapes may be conceived by the skilled artisan.

FIGS. 17 through 20illustrate two varieties of a different type of internal retention bolster, also in keeping with the purposes and function of new COP10. Bolster516, shown inFIG. 17consists of a series of twisted filaments or “wires”82fixed at both ends of each filament to the outer side wall of catheter14, longitudinally in relation to the catheter and spaced apart from one another, preferably around the entire perimeter of the catheter. The number and size of filaments82will vary, depending upon the size of COP10, the implantation site and the patient. As shown in phantom inFIG. 17, filaments82of bolster516may be (but are not necessarily) entirely encapsulated within a membrane or capsule84of soft, flexible sheet-like material, such as a type of polyurethane, for example, which is sealed at two ends thereof to the outer cylindrical side wall catheter14, beyond the ends of filaments82.

Filaments82may be formed of any suitable flexible material with sufficient material “memory” that the original bent shape of the filament will be sought after some deformation resulting from shifting in internal body pressures, so that the bolster is effective in keeping COP10in a secure leakage proof seat in the stoma. At the same time, the material of filaments82must be sufficiently pliable that the bolster will “give” as necessary to avoid tissue damage.

Thus, filaments82may be formed of certain plastics, either existing or yet to be conceived, and may also be formed of certain metals. In the case of metals, a number of known metals and alloys thereof are deemed suitable. However, the most preferred and commercially available metal of which filaments82are formed is a nickel-titanium alloy referred to as nitinol, a metal that is particularly suitable for this purpose due to characteristics such as pliability, kink-resistance, biocompatibility , shape memory, and fatigue resistance. Thus, in the case of the COP10shown inFIG. 17, wherein the bolster includes a plurality of filaments, (e.g. encapsulated wires82of nitinol), the filaments or “wings” can be pre-shaped and spaced according to the patient's particulars, including size and position of the intestinal vasculature proximal of the stoma. This embodiment of COP10may require an external orientation system, such as arrow A or other indicator applied to face plate12to ensure appropriate placement within the stoma. Once implanted, as part of the COP, when the patient experiences an internal pressure change, for example, from bending and lifting, filaments82of nitinol will bend out of the shape shown, in order to accommodate any bending and compressing of surrounding tissues, without creating increasing deflection force from the nitinol wires82as the wires become compressed within the body. Then immediately resume the illustrated shape when the user stands upright or otherwise shifts from the bending position, which initially caused the deformation.

FIGS. 18–20illustrate bolster variety616in relation to continent ostomy port100(the anti-reflux valve not shown, for simplicity of the figures). Bolster616is shown in this instance connected to or formed as an integral extension at the proximal end of catheter114. Bolster616is preferably formed at least in part of plastic, but may also be at least partly formed of metal or other biocompatable, resilient material. The cross-sectional view inFIG. 20illustrates three support “spokes”90extending radially outwardly from catheter114, and the flexible, sheath-like wall of bolster capsule92(not shown inFIG. 19, for simplicity). Two of such spokes90can be seen inFIGS. 18 and 19, longitudinal sectional schematic views. InFIG. 18bolster616is shown as being forced into a spokes-extended disposition by a known obturating device94. In this position COP100with the illustrated bolster616style is inserted into a stoma. The distal ends of extended spokes90are connected to one another by an annular connection piece96. Once inserted deeply enough, with face plate112in substantially parallel and adjacent proximity to the stoma tissue T′ obturator94is removed and spokes90resume the folded operative position illustrated schematically inFIG. 19. Note that in this embodiment, no “breather” valve is necessary. The valve and duct arrangement illustrated is for purposes of inflation/deflation of an anti-reflux valve (not shown) of a type previously discussed.

The new internal retention bolsters described above for COP10,100are all bioresponsive in nature. Even though the expandable foam style cuffs are encased in a membrane, the system is not actually closed. On the contrary, air contained in and around the bolster can freely escape via the breather duct48and port52, thus allowing the internal bolster to temporarily slenderize whenever the intestine demands that it should, due to a spike in surrounding abdominal pressures. (Further, the “wire” styles are also all designed to give as necessary. If desired, the wire styles can also be provided with a breather valve52, as illustrated in the embodiment shown inFIG. 17for example.) The described foam and wire/metal cuffs also abruptly re-expand to respective predetermined shapes and sizes as soon as the spike of intra-abdominal pressure subsides.

Among the various optional accessories that are conceived for convenient hands-free use with the new continent ostomy port device10is a flat bag or pouch86, ordinarily intended for only occasional use, such as when intermittent drainage in remote locations is desired. A preferred embodiment for pouch86is illustrated inFIG. 8.FIG. 7illustrates an example of an optional connector88for temporarily attaching pouch86to the distal end of catheter14as it opens through plate12. For example, the small end88A of connector88is inserted into the center of collar34of the new COP, and the opposed, larger end88B of connector88is sized and shaped to fit, liquid-tight (although allowing passage of gasses), into a correspondingly shaped receiving member98which is attached by a flange98A to one side of bag86, as illustrated inFIG. 8. If desired, port connection end88A can also have, for example, formed detenting ridges or grooves, indicated in phantom at88C,88D, respectively, as however corresponds to the structure internally of the collar of whatever style of collar, e.g.34,134is in use in the particular device10,100selected. Alternatively, receiving member98on bag86may be modified to connect directly to collar34,134of the new ostomy port.

Collection bag86has a relatively flat or “low” profile when empty, consisting of two sheets99(only one of which is visible in the figure) of sheet-like material joined together in overlying relationship and sealed in a liquid tight manner, for example by heat sealing or adhesive along seal line99A, preferably around the perimeter of bag86. In keeping with the intention for pouch86to be used as the exception, rather than as the rule, it is relatively small as compared to conventional colostomy bags, having a volume of only up to about 200 cc. Further, preferably being formed of a natural fiber or other biodegradable material, bag86is suitable for flushing down a conventional toilet without undue risk of blockage of the sewage system.

Of course the precise shape, construction, materials and attachment of bag86may vary and remain within the scope of the invention for use in combination with the new COP. It is necessary, however, that the new ostomy pouch86be of small enough size that when fill it does not place undue strain caused by excess weight, on port10,100. Further, pouch86must be adapted or have an appropriate connector such as88, for liquid-tight connection to new port device10,100. When so constructed, it is very easy for the ostomate to connect bag86and to then go about the tasks of daily life as the bag fills.

By way of comparison, standard ileostomies have a very high output of fluid, generally producing and average of about 1,000 cc of highly corrosive matter daily. Previously, individuals with this type of ostomy, and who sometimes were not candidates for surgical construction of internal reservoirs, had no other choice but to wear pouches at all times. Due to the size and filled weight of these bags, it is often necessary for the user of such known pouches to also use some sort of belt arrangement to help to support the filling and filled pouch. No such extra support devices are required with the small, “low-profile” pouch of the present invention.

Since the stools produced by ileostomies are very loose and watery, they tend to be very difficult to contain. Leakage and skin trauma inherent with these leaks are consistently rated as the number one hardship facing ileostomates. The new COP10in combination with the new, liquid-tight, intermittent use, mini-drainage bags provides such normally young ileostomates with a long-awaited solution to permit a much more active life-style, and help to ensure that the new COP can accommodate most normal and emergency situations that an ostomate will encounter. No adhesives or belts and the like are necessary for the ostomate to take advantage of this hands-free convenience.

FIGS. 21A through 21Eillustrate an example of use of ostomy device100. Identical steps can be taken with use of device10. Generally,FIG. 21Ashows device100with the closure member in closed, operative position at the distal end of device100. A deodorizing cartridge70′ is in position within the lumen of the catheter portion of the ostomy device and an anti-reflux valve is deflated to permit gasses to seep through the cartridge and out through the vent hole(s) in the closure member.

FIG. 21Bshows device100with the closure member open, the cartridge partially backed out of the lumen until the anti-reflux valve is inflated by introduction of air with a conventional syringe via a schematically indicated one-way valve, such as a Halkey Roberts valve, into the minor lumen previously described. This step is reversed when it is time to reinsert a new cartridge.

In the step illustrated atFIG. 21Can ostomy bag is connected to the open, distal end of device100. Thereafter, the anti-reflux valve can be completely deflated to permit body waste to exit into the bag, or, more commonly, a drainage tube, such as that shown inFIG. 22, for example. Once the intestinal (or other stoma site organ) contents are voided the anti-reflux valve is again completely inflated and the entire bag and contents thereof are flushed away into a commode, as indicated inFIG. 21D.

Finally, as shown inFIG. 21E, a fresh deodorizing cartridge is partially inserted and the anti-reflux valve is deflated. When the anti-reflux valve is completely deflated, the new cartridge is fully seated in the device100and the cap of the closure member is then closed (not shown in this view), permitting gasses to freely seep through the cartridge while maintaining liquid and solid body waste securely within the ostomy.

FIGS. 22 and 23illustrate a few types of accessories, which optionally may be used with the new ostomy port10,100and useful variations of the embodiments thereof. It is to be understood that these devices are shown only as examples and do not limit the potential devices with which the new COP may be conveniently used.

FIG. 22illustrates schematically, in longitudinal section, a connector77attached to one end of an ostomy drainage tube83. Connector77is sized and shaped to provide a liquid-tight fit within collar24and to engage and lock onto detent bars36, as by corresponding detenting grooves, similar to those described with regard to cap28and thus is designed particularly for the ostomate's selective and convenient use in combination with COP10.

FIG. 23shows two irrigation set connectors87,89for attaching suitable tubing91,93(preferably medical grade), respectively to irrigation and/or drainage sets to COP10. Connectors87,89are adapted for liquid-tight, interlocking connection within collar34, and preferably include detent grooves85which function the same as those on closure portion18(element number40), by engaging and retaining detent bars36. With a connector87,89so securely engaged within port10the user can proceed with the necessary hygienic processes “hands-free”; i.e., without the necessity of holding the drainage/irrigation tube connector in place at the port. Rather, the user's hands are available to do other things, such as shaving, for example, while the irrigation process takes place. Alternatively, for use with ostomy port device100, the accessory connectors can be provided with a detenting annular ridge. This alternative structure and the hands-free use feature are also common to the just described drainage tube connector illustrated inFIG. 22.

FIGS. 24 through 26schematically illustrate a further optional feature of COP10, which can conceivably, although less conveniently, be adapted to COP100, as well.FIG. 24shows the distal portion of COP10, without the cap, in longitudinal section. An annular ridge or pawl45protrudes slightly into lumen26, just proximally of shoulder35. Ridge45is palpably contacted by corresponding ridges on a variety of ostomy accessories. For example, ridges47,51on an irrigation set connector49or a cone-tipped obturating device53, respectively, such as those illustrated inFIGS. 25 and 26will bump over ridge45as such devices are pushed into or pulled out of port10. The purpose of this feature is to provide the user with sufficient additional resistance to tactilely detect that the accessory being removed is sufficiently far out of lumen26that the anti-reflux valve should be activated to prevent accidental release of body wastes.

Once the ARV is fully inflated the accessory in use can be completely removed from port10and cleaned or discarded. Useful alternatives to the above-described structure include replacement of pawl45with one or more slightly raised bumps or arcuate but non-annular ridges, so that less irregular surface area is present which can trap fecal material within lumen26.

FIG. 27schematically illustrates another practical use for ostomates having the new COP10,100in operative position. For those ostomates who have a surgically created internal reservoir95, such as the types commonly known as “Kock” and “Indiana” pouches, for waste collection. These patient's have historically been provided with a nipple valve formed of the patient's own tissue. Unfortunately these tissue valves are notorious for a high failure rate. Now, such nipple valves may not be necessary, and, as an alternative device10can be implanted through the skin, indicated in section at S, and the patient's abdominal wall such that catheter24provides external fluid communication from the reservoir95to exterior of the body.

In the case illustrated inFIG. 27, device10(or100and the corresponding structure thereof) can be kept with the cap closed and with the anti-reflux valve not activated until it is necessary to void the contents of the reservoir. Cap38is then opened and, with the cartridge partially retracted the ARV valve is fully activated, and then the filter cartridge (previously described, not shown in this view) is completely removed and a drainage tube97of known variety, such as that commonly known as the “Median-type tube”, or any new or equivalent such tube, which will fit snugly into lumen26, or sealingly into collar34, is inserted. Then the anti-reflux valve is fully opened and the reservoir contents are voided into a toilet or other appropriate container (not shown).

Use of the new continent ostomy port and accessories thereto is very simple and can be managed by the ostomate or a caregiver with very little training. The user ostomate has the benefit of new port10as a barrier to withhold all bowel contents intestinally until drainage is desired. Although serving as a barrier to the internal bowel, new device10is primarily a continent port which allows passage of bowel gasses through the odor controlling filter cartridge and the vented cap to prevent painful buildup of bowel gas and bloating which would necessarily occur if no venting were provided. Then, when drainage of fecal (or other body waste) matter is desired, the ostomate engages the anti-reflux valve to temporarily seal the proximally disposed (internal) end of the lumen of the port.

The closed ARV valve thereby prevents any inadvertent escape of fecal material into the port while the odor control cartridge is being removed and a drainage or irrigation device is being attached (during ostomy drainage and/or colostomy irrigation). Then the ostomate removes, cleans and reinserts, or replaces the cartridge. Alternatively, a conventional, non-flushable bag can be temporarily connected to the port, if necessary. After the inflation/drainage process is complete, the ostomate cleans and reinserts or replaces the cartridge, depending upon the user's preference at the time.

Upon connection of the desired accessory, for example, as illustrated inFIG. 22, the user will simply deactivate the anti-reflux valve and purge the bowel of its contents. The purging process, as well as irrigation of the bowel can be done in the conventional manner, with the advantageous exception that once the irrigation or purging tube is connected the user's hands are free to attend to other tasks, such as shaving, make-up application, or otherwise, all while either the purging or irrigation process is carried on. Once drainage of the intestine is complete, and prior to removal of accessory from the COP aperture24, the ARV is again activated while a new odor control cartridge is inserted. Then the anti-reflux valve is fully deactivated (opened) and the vented cap is returned to the closed position, permitting the ostomate to go on about the business of daily life. The ostomate is thus free of the burdens of cumbersome and uncomfortable bag attachments, constant concerns regarding unpleasant odors, noises, leakage and tissue irritations, and continual discomfort and expense associated with dependence on external bonding substrates such as glues, gums, and pastes or belts and straps.

With reference toFIGS. 28 through 35, there is disclosed another embodiment of the moisture barrier previously discussed herein with reference toFIG. 4.FIGS. 28–30illustrate a “shim”, generally designated157, which is optionally used with a moisture barrier/pad158described hereafter. Shim157is substantially flat and in the preferred embodiment shown has a generally oval-shaped perimeter157a, as illustrated inFIG. 28. Perimeter157ais shaped to match the perimeter of pad158. Thus, if the shape of the pad is something other than oval, if desired, the exterior perimeter of shim157can be altered accordingly. The overall size of shim157can vary, as desired, to either match the size of moisture barrier/pad158, so as to act as a riser for the COP face plate, or the shim may be sufficiently smaller in exterior dimension to permit it to be seated within the underside (proximally) of COP 200 for enhanced absorption of stomal fluids.

The sectional views shown inFIGS. 29 and 30illustrate an example of useful dimensions (in inches) for shim157, but it is foreseen that other dimensions will suffice, depending upon the particular circumstances of use, including stoma size and COP dimensions.

Shim157has a preferably circular interior side wall, which defines a through-hole157bto surround the stoma. The size and shape of the throughhole can be varied as may be necessary to accommodate any variations in size and shape stomas of various individual users. The arrow indicated by “X” inFIG. 29illustrates one useful surface site on shim157for optional application of an adhesive, such as a pressure sensitive adhesive and/or web adhesive, for example.

FIGS. 31–35illustrate an alternative embodiment, generally designated158, of the new moisture barrier/pad. Inconsistencies in size between the figures may exist due to copying anomalies. In the preferred version shown, pad158is formed of molded foam material and has a low profile, as seen ifFIG. 33, with a generally oval perimeter158a(FIG. 35), although other perimeter designs can be useful. The pad body159has an outer (distal) surface159athat is slightly domed, but formed in the central portion thereof with an indented region that accommodates the distal portions of a COP, such as that generally designated as 200 inFIG. 32. In this embodiment, upper surface159ais formed with a central depressed area that is generally cross-shaped, extends down into the body159and has a substantially flat floor163. Floor163defines a central aperture160with a side wall161, which is shown circular, but can be other shapes, if desired, to accommodate the shape of a catheter, such as that indicated at214inFIG. 32.

Floor163of pad158extends away from aperture160in two opposed channels165, each having opposed, angled side walls167, as seen most clearly inFIGS. 31,32and33. Channels165offer easy finger access to an optional grip242on a cap228of a COP.

Floor163extends at approximate right angles to channels165from aperture160in two opposed cut-out areas169bounded by arcuate walls171disposed radially outwardly from the center of pad158. Floor163between cut-out areas169may be in the same plane as floor163between channels165, if desired, or slightly stepped down, as is preferred and as is shown inFIG. 31. Cut-out areas169provide spaces in pad158to accommodate the COP 200 features, such as a bolster inflation port, as indicated at252, or an access port for an ARV, as indicated at254inFIG. 32.

FIG. 34shows that the lower (proximal) surface of pad158is preferably, although not necessarily, provided with a depending ring158b. Ring158bis disposed coaxially with opening160, but spaced radially outward from opening160by a sufficient distance that ring158bcan be positioned outwardly of the stoma when pad158is in normal use position. Ring158bpreferably extends transverse to pad body159, and slightly past the proximal extent of body159, as illustrated inFIG. 33. Alternatively, ring158bcan be omitted altogether, or can be shorter than the depth of the perimeter of pad158. When ring158bis present, a preferably continuous channel158cis formed between ring158band perimeter158aof pad158. Channel158cis optionally sized and shaped to correspond to and to receive shim157, so that shim157is disposed in normal use between the bottom of pad158and the user's skin. Shim157can also be nested in the underside of pad158without the presence of ring158b. This arrangement is especially useful if the shim is to provide wicking properties. Alternatively, as previously discussed, the shim can have exterior dimensions which correspond to the exterior perimeter dimensions of pad158, or which even extend slightly beyond the perimeter of the pad.

In view of the foregoing, it will be seen that the several objects of the invention are achieved and other advantages are attained.

Although the foregoing includes a description of the best mode contemplated for carrying out the invention, various modifications are conceivable.

As various modifications could be made in the constructions herein described and illustrated without departing from the scope of the invention it is intended that all matter contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative rather than limiting. For example, the overall shape and size of both the face plate and the catheter portions of port10can be varied.