Patent Description:
Surgical procedures such as a colostomy, urostomy and ileostomy involve rerouting of the colon or ureter so that effluent can be discharged through an artificial opening formed in the ostomy patient's (also referred to herein as ostomate) body. This artificial opening, called a stoma, is typically located in the abdomen and may be about <NUM> to <NUM> (<NUM> to <NUM> inches) or more in diameter.

The new artificial opening, or stoma, made on the abdominal wall, has no voluntary sphincter control by the ostomate. Collection of involuntary waste seepage is by a pouching system, typically comprising a pouch and baseplate, or other receptacle attached to the ostomate's body, where the pouching system is disposed of after use, and replaced with a fresh pouching system. Typically, such pouching systems are attached to the body over the stoma by means of a baseplate with adhesive backing which must be positioned over the stoma with precision to achieve a reliable attachment and seal. It is essential that this baseplate be mounted directly and concentrically over the stoma and further, that it be tightly secured to the body, otherwise leakage of waste onto the surrounding skin area can occur.

The pouching system is typically replaced every <NUM> to <NUM> days, with the replacement process typically taking <NUM> to <NUM> minutes. During the pouching system replacement process, while the pouching system is removed and the peristomal skin is exposed, the common practice has been to first clean and dry the peristomal skin, then treat and medicate any skin irregularities, followed by thorough drying of the skin and application of the new pouching system. Continued seepage of effluent and other uncontrollable factors, often cause the ostomate to hasten the process and apply the new pouching system prematurely, leading to further exacerbation of any emerging or existing skin conditions. Patients often experience acute or chronic peristomal skin conditions caused by medical adhesive related skin injury, moisture associated skin damage, allergic reactions to ostomy supply materials, and extended wear times with limited time to adequately treat skin before applying the new pouching system.

Attempts have been made to improve the procedures mentioned above for replacing pouches and cleaninga stoma or fistula and surrounding areas. The following references represent some of these past attempts.

A device (<NUM>) for evacuating waste product through an orifice in a mammalian body, the device (<NUM>) including a chamber (<NUM>) having an irrigating means (<NUM>) for introducing an irrigating fluid into the orifice and a suction means (<NUM>) for removing the irrigating fluid and waste products from the orifice.

Devices for insertion into a stoma formed in a patient's body are provided, comprising a tube having distal and proximal ends and defining a path for movement of waste. To retain the device in the stoma and seal the stoma, the tube includes a retention mechanism located on the distal end and/or a sealing mechanism extending along a length of the tube between the proximal and distal ends. Collection apparatus for collecting waste from a patient's body also are provided, comprising a waste pouch and a connector for connecting the collection apparatus to a device inserted into a stoma. Additionally, waste collection systems for collecting waste from a patient's body are provided, comprising a tube for insertion into a stoma and a waste pouch. Each system may comprise a separate tube and waste pouch or the tube and waste pouch may be formed as an integral inseparable component.

The invention provides a stoma drainage bag support frame. The support frame comprises a first annular bracket, a second annular bracket and connecting rods, the outer diameter of the second annular bracket is smaller than the inner diameter of an opening of a drainage bag, the number of the connecting rods is three, the connecting rods are evenly arranged on the first annular bracket and the second annular bracket and connect the first annular bracket with the second annular bracket, the vertical distance between die first annular bracket and the second annular bracket is <NUM>-<NUM>, and the second annular bracket is provided with three convex portions, wherein the three convex portions are arranged at the joints of the connecting rods and the second annular bracket, externally protrude in a same plane with the second annular bracket and are used for fixing the bracket in a base plate ring of the stoma drainage bag. The stoma drainage bag support frame is placed between a drainage base plate and the drainage bag, by means of the support frame, damage to or necroses of a gut or an external segment of a ureter under pressure caused by negative pressure generated by drainage is avoided, and meanwhile, the phenomenon of liquid backflow caused by negative pressure effect and infection of a patient are avoided, so that health of the patient is guaranteed.

Each of the devices and methods set forth above are useful, but these advancements also have disadvantages. It would be desirable, therefore, to provide an ostomy output diversion device that is simple to use, inexpensive to manufacture, and which provides a useful and efficient way to maintain the health and cleanliness of a patient's stoma and surrounding skin and tissue.

<CIT> provides a a device for coveying fluids into and out of a colostomy opening, inlcuding conduit means, a radial flange integral with the conduit means, pressure means for maintaining the flange in direct contact with a stoma and base means for preventing fluid communication between a cavity and an abdominal wall is prevented.

<CIT> discloses a valve assembly used in conjunction with a colostomy bag assembly. The colostomy bag assembly includes a bag, a proximal ring and a distal ring.

<CIT> discloses an ostomy belt system includes an ostomy belt having a strip of material and a belt coupling element, and an ostomy pouch having and outer wall defining an inner volume, and a pouch coupling section configured for releasable engagement with the belt coupling element. One or both of the belt coupling element and the pouch coupling section is configured to bend or flex at a predetermined location.

<CIT> discloses devices for insertion into a stoma formed in a patient's body are provided, comprising a tube having distal and proximal ends and defining a path for movement of waste. To retain the device in the stoma and seal the stoma, the tube includes a retention mechanism located on the distal end and/or a sealing mechanism extending along a length of the tube between the proximal and distal ends. Collection apparatus for collecting waste from a patient's body also are provided, comprising a waste pouch and a connector for connecting the collection apparatus to a device inserted into a stoma. Additionally, waste collection systems for collecting waste from a patient's body are provided, comprising a tube for insertion into a stoma and a waste pouch. Each system may comprise a separate tube and waste pouch or the tube and waste pouch may be formed as an integral, inseparable component.

The present invention relates to a medical device designed to capture ostomy effluent output without the need of an ostomy pouching system, allowing extended periods of time without skin being covered by an adhesive baseplate, and designed to improve chronic and acute peristomal skin conditions.

In a first embodiment, the ostomy output diversion device includes a main body member, the outer frame of the main body member is shaped in a manner to extend away from the body, with space between the frame supports to allow open access to the peristomal skin, allowing patients to treat and medicate the peristomal skin, and to leave the skin uncovered for an extended period of time an inner tube guide for aligning and supporting an inner tube, an inner tube member positioned through the center of the main body member and inner tube guide and adjustable to allow movement within the main body member and inner tube guide, a stoma-sized adapter attached to the bottom end of the inner tube member and sized to fit over the stoma, a sealing ring attached to the bottom of the stoma-sized adapter to prevent effluent from seeping between the adapter and adjacent skin, a pressure adjustment lock to apply adequate pressure between the stoma-sized adapter and the adjacent skin during application, an effluent draining tube attached to the drain tube connector on the distal end of the inner tube, the opposite end of the effluent draining tube leading to a reservoir container to contain effluent output, with an adjustable body support strap used to secure the device to the body during application.

These and other features, aspects, and advantages of the present invention will become better understood with regard to the following description and accompanying drawings where:.

<FIG> illustrates an embodiment of the present invention whereby the ostomy output diversion device includes a main body member <NUM> having a base ring <NUM>, support members <NUM> attached to the base ring <NUM> on a first end thereof, and an outer frame <NUM> attached to the support members <NUM> on a second end thereof. In a preferred embodiment, the outer frame <NUM> extends away from the patient's body, with space provided between support members <NUM> to allow open access to the peristomal skin. The base ring <NUM> may be constructed of any suitable material, but preferably of soft material for skin contact comfort. In one embodiment, the base ring <NUM> may be malleable, so that a patient may form the base ring <NUM> into any desired shape or configuration to conform to the contour of his or her abdominal shape, as desired, for ease of use. In this embodiment, the base ring <NUM> may be made from flexible materials, such as rubber, foam, or other suitable formable materials, and may also include a structural wire to allow the base ring to maintain the desired configuration formed by the patient. In some embodiments, the base ring <NUM> may be removable and replaceable with base rings of other sizes, shapes, or configurations.

In a preferred embodiment, the ostomy diversion device further includes a centrally located inner tube member <NUM>, positioned through the center of the main body member <NUM> and an inner tube guide <NUM> that is held in place by support spokes <NUM> that are attached to the inner portion of the support members <NUM>. A stoma-sized adapter <NUM> is attached to the proximal end of the inner tube member <NUM> and sized to fit over the stoma or fistula, and the adapter <NUM> includes a sealing ring <NUM> that is used to prevent effluent from seeping between the stoma-sized adapter <NUM> and adjacent skin. The inner tube member <NUM> is preferably telescopic in nature, and is incrementally or infinitely adjustable inwardly and outwardly in linear fashion, in order to allow movement within the main body member <NUM>. A pressure adjustment lock <NUM> is used to apply and maintain adequate pressure between the stoma-sized adapter <NUM> and the adjacent skin during application. In use, when the base ring is placed in the proper position against a patient's skin, the inner tube member <NUM> may be extended toward the stoma or fistula to ensure a tight fit, and the pressure adjustment lock <NUM> is used to maintain the extended position thereof. The pressure adjustment lock <NUM> may be disengaged and repositioned during use, or after use, as desired.

In a preferred embodiment, the ostomy output diversion device includes a removable body support strap <NUM> and strap mounting ring <NUM>, used to secure the ostomy output diversion device to the body during application. The removable body support strap <NUM> may be affixed to the strap mounting ring <NUM>, which fits over or onto the distal portion of the outer frame member <NUM>, as shown in <FIG>, or the strap <NUM> may be affixed to other portions of the device, such as the base ring <NUM> as shown in <FIG>. Any suitable strap means may be used to attach the device to a patient's body, so long as the device, and specifically the sealing ring <NUM> of the stoma-sized adapter <NUM> are held firmly in place against the patient's skin, in order to prevent any effluent from leaking therefrom.

In a preferred embodiment, the ostomy output diversion device includes a drain tube connector <NUM>, used to connect a drain tube <NUM> to the distal end of the inner tube <NUM>, and to a reservoir <NUM> to collect ostomy output. Essentially, a clear drainage passage is formed from the adapter <NUM> through the inner tube <NUM>, the tube connector <NUM>, and into the drain tube <NUM>, so that effluent may pass unobstructed from the stoma or fistula to the reservoir <NUM> without leakage from any point along the way. In a preferred embodiment, a hollow elbow joint <NUM> may be affixed to the tube connector <NUM> on a first side thereof, and the second side of the elbow member <NUM> may be attached to the drainage tube <NUM> leading to the reservoir <NUM>, as shown in <FIG>. The elbow joint <NUM> may be formed into any desired angle, and preferably is formed into an angle in the range of <NUM> to <NUM> degrees. This arrangement allows the drainage tube <NUM> to extend in any desired direction toward the reservoir <NUM> in a low profile manner, rather than having the drainage tube <NUM> extend in linear fashion from the tube connector <NUM>, which may be awkward or cumbersome in some situations or tight spaces.

<FIG> illustrates an embodiment of the present invention whereby the ostomy output diversion device is strapped on a person in a typical manner, covering and sealing over the person's stoma or fistula, allowing effluent to exit the stoma or fistula, pass through the ostomy output diversion device, into a drain tube <NUM> attached to the drain tube connector <NUM> of the ostomy output device, and into a reservoir <NUM> for collecting ostomy output.

<FIG> illustrates an embodiment of the present invention whereby the ostomy output diversion device has a body support strap <NUM> and strap mounting ring <NUM> that fits over the distal end of the outer frame <NUM>, so that the strap is used to secure the ostomy output diversion device to the body during application. <FIG> illustrates an embodiment of the present invention whereby the body support strap <NUM> and strap mounting ring <NUM> are removable from the ostomy diversion device.

<FIG> illustrates an embodiment of the present invention whereby the body support strap <NUM> is integrally formed with the base ring <NUM> for securing the ostomy output diversion device to the body during application.

In use, after an ostomy patient has removed a used bag and attachment apparatus and cleaned the skin around the stoma or fistula, the patient places the base ring <NUM> firmly against his skin so that the adapter <NUM> is positioned over the stoma or fistula. The patient then extends the adapter <NUM> inwardly toward the stoma or fistula until the sealing ring <NUM> is firmly in place around the stoma or fistula and secured in place by the pressure adjustment lock <NUM>, and then affixes the strap ring <NUM> around the distal portion of the outer frame <NUM> and secures the strap <NUM> around his body. The next step includes affixing the drainage tube <NUM> to the tube connector <NUM> (or affixing the drainage tube <NUM> to the elbow joint <NUM>, and the other side of the elbow joint <NUM> to the tube connector <NUM>), and connects the other end of the drainage tube <NUM> to a reservoir <NUM>. It should be understood that some of these steps may be combined or performed out of the recited order.

This device allows the peristomal skin around the stoma to remain uncovered for extended periods of time, so that it can breathe and potentially be treated with an ointment, salve or other topical medical treatment, for as long as the patient desires. Once the ostomy output diversion device is properly secured to the patient's body, the patient's hands can remain free of the device, and may be used for other tasks or activities (or may simply rest) while the device is held in place by the straps <NUM>.

<FIG> show another embodiment of the present invention, wherein the strap ring <NUM> includes a pouch mounting ring <NUM> on an outer portion thereof. An ostomy pouch <NUM> may be removably attached to the pouch ring <NUM> in order to receive effluent from the patient's stoma or fistula while the ostomy output diversion device is properly secured to a patient's body.

<FIG> illustrate another embodiment of the present invention, wherein an output adapter <NUM> may be removably secured to the strap ring <NUM> (or, alternatively, to a pouch mounting ring <NUM>). The output adapter <NUM> is attached to a drainage tube, which in turn is operatively attached to a reservoir for receiving effluent from the patient's stoma or fistula.

In another alternate embodiment, the inner tube member may be removable and interchangeable with a disposable cartridge or receptacle, such as a receptacle as described in <CIT>. In this embodiment, the disposable receptacle may be inserted into the outer frame member and used to receive the effluent from the stoma or fistula while the ostomy output diversion device is in place on a patient's body. Then, the disposable receptacle containing the effluent may be removed, sealed, and properly disposed of.

In another embodiment, as shown in <FIG>, an ostomy output diversion device includes a main body member <NUM> having a base ring <NUM>, support members <NUM> attached to the base ring <NUM> on a first end thereof, and an outer frame <NUM> attached to the support members <NUM> on a second end thereof. An inner tube <NUM> is positioned on an inner portion of the outer frame member, and includes a first opening that fits over a stoma or fistula, where the first opening is located generally in a central position with respect to the base ring. A second opening is positioned on a lower portion of the inner tube, and is attached to a drainage adapter for receiving a drainage channel. As in other embodiments described herein, the other end of the drainage channel may be attached to a pouch or reservoir for collecting effluent that flows outwardly from the stoma or fistula, through the first opening in the adapter, and downwardly through the second opening and into the drainage channel. The outer frame <NUM> defines a centrally located opening on a distal end thereof, which is on an outer portion of the device on an opposite end from the base ring. The centrally located opening in the outer frame member allows a user or health care provider to look therethrough for purposes of aligning the first opening on the adapter with the stoma or fistula on a patient's body. A removable concealing cap <NUM> may be affixed to the inner tube member <NUM>, as shown in <FIG> and <FIG>, to cover the centrally located opening. Additionally, adjustable tension straps <NUM> may be affixed to the removable concealing cap <NUM>, and the adjustable tension straps may be used to <NUM>) maintain the removable concealing cap <NUM> in place on the inner tube member <NUM>, and <NUM>) to provide additional tension to the inner tube member for a snug fit of the inner tube against the skin next to a patient's stoma.

In an embodiment shown in <FIG>, the concealing cap also includes an odor filter <NUM> that essentially serves two primary purposes: <NUM>) it releases gases trapped in a user's body as part of the natural digestive processes, and <NUM>) reduces or eliminates the odors that are associated with such gases. In embodiments that do not include an odor filter, an air valve or gas bleed valve may be incorporated into the system for releasing gases. Odor filters are widely available commercially. For example, bamboo air purifier deodorizing carbon charcoal filters are sold commercially for use with diaper pails by Ninja Mama on Amazon. Bush Systems sells carbon odorless cloth diaper pail filters on Amazon. com, and Arm and Hammer sells nursery fresheners that include baking soda and assorted scents. Any of these types of odor air filters may be used in conjunction with the present invention, as well as any other suitable air filters.

It should be understood that other structural arrangements may be used.

For instance, it is conceived that one, two or more support members may be used, rather than the four support members shown in the Figures, in order to provide easier access to the peristomal skin while the ostomy output diversion device is strapped onto a patient's body.

Although the present invention has been described in considerable detail with reference to certain preferred versions thereof, other versions are possible.

Claim 1:
An ostomy output diversion device (<NUM>) comprising;
a base ring (<NUM>);
an outer frame member (<NUM>) attached to said base ring (<NUM>);
a hollow inner tube (<NUM>) positioned inside said outer frame member (<NUM>);
wherein said inner tube (<NUM>) includes a first opening (<NUM>) for receiving effluent from a stoma and includes a second opening for drainage of effluent characterized by said inner tube (<NUM>) being slidable in a longitudinal direction with respect to said outer frame, so that said inner tube (<NUM>) is linearly adjustable toward and away from said stoma; and
said second opening further including an inner tube adapter for receiving a drainage channel.