|Publication number||US7879016 B2|
|Application number||US 11/096,446|
|Publication date||Feb 1, 2011|
|Priority date||Feb 8, 2002|
|Also published as||DE60231656D1, EP1471856A1, EP1471856B1, EP2050419A2, EP2050419A3, EP2050419B1, US6887222, US20030153882, US20060015079, WO2003065944A1|
|Publication number||096446, 11096446, US 7879016 B2, US 7879016B2, US-B2-7879016, US7879016 B2, US7879016B2|
|Inventors||Taras Mandzij, Michael A. Metz, Tim Friske, Michael S. Cherry|
|Original Assignee||Hollister Incorporated|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (78), Non-Patent Citations (1), Referenced by (14), Classifications (12), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a Continuation of U.S. patent application Ser. No. 10/283,801, filed Oct. 30, 2002, which issued as U.S. Pat. No. 6,887,222, and this application claims priority to, and the benefit of the filing date of, U.S. Provisional Application No. 60/355,489, filed Feb. 8, 2002, for all subject matter commonly disclosed therein.
Drainable ostomy pouches are well known as shown, for example, in Nolan U.S. Pat. No. 3,523,534 and Jensen et al. U.S. Pat. No. 4,441,659. Such a pouch typically has flat opposing sidewalls secured together along their edges and defining a chamber for receiving body waste material. One of the walls is provided with a stoma-receiving opening, and means are provided for securing the pouch to a patient's abdomen so that waste discharge from the stoma is received in the cavity. At its lower end, the drainable pouch has a discharge opening for draining waste material, usually provided at the end of a narrowed neck portion. Closure means is provided for maintaining the discharge opening in sealed condition until such time as waste material is to be drained from the pouch. The closure means may take the form of a clamp, as in the aforementioned Nolan patent, or some device for securing the neck portion in upwardly-rolled condition. As will be appreciated, conventional wire ties or wraps have also been used for that purpose.
A drainable pouch is reusable following periodic emptying of waste material, but cleaning is necessary prior to reuse so that effective sealing can be assured and odors emanating from the resealed pouch can be avoided. Users often encounter difficulty and discomfort in unsealing, emptying, cleaning and resealing drainable pouches because of the direct exposure to waste material and because the manipulations may require greater dexterity than a patient, particularly an elderly patient, can provide. Adding to the problem is the fact that residual amounts of solid and/or liquid waste matter at the lower end of a drainage pouch tends to block or hold the walls of the pouch together, making cleaning of the inside surfaces adjacent the drain opening even more difficult.
The drainable ostomy pouch of the invention has conventional sidewalls of flexible sheet material joined along their edges to define a downwardly extending neck portion terminating in a discharge opening. The discharge opening is closed by folding the neck portion upwardly and opened by folding the neck portion downwardly for draining the contents from the cavity. Each of the sidewalls of the neck portion is provided with a transversely-extending bias member in the form of a closure strip of flexible but stiff or springlike polymeric material. The strips located along opposite sidewalls adjacent to or near the discharge opening are normally flat and disposed in straight parallel closed relation but are openable under inwardly directed finger pressure applied to opposite ends thereof. By applying inwardly directed finger pressure, the bias members or closure strips are caused to be bowed away from each other to hold the discharge opening in an open condition for draining the contents from the cavity.
In one form of the drainable ostomy pouch, the bias members are laterally offset from one another whereas in another form of the pouch, the bias members substantially conform in size and shape and they extend continuously or uninterruptedly from one joined edge to the other. In yet another form of the drainable ostomy pouch, the bias members substantially conform in size and shape but extend less than the entire distance from one joined edge to the other, such members being centered relative to the discharge opening.
In another respect, the drainable ostomy pouch has a discharge opening that is placed in closed condition by folding the pouch in a first direction (away from the wearer's body) and is placed in an open condition by unfolding the pouch in a second, opposite direction. A two-part fastener is provided for selectively holding the discharge opening in the closed condition, and it includes a first part associated with the pouch generally adjacent to or near the discharge opening and a second part associated with the pouch spaced further from the discharge opening than the first part. More specifically, the second fastener part is spaced from the discharge opening to require folding the pouch until the first fastener part comes into confronting relation with the second fastener part for engagement therewith.
In yet another respect, the drainable ostomy pouch has a two-part fastener associated with a neck portion leading to the pouch's discharge opening. The fastener comprises a first fastener strip with locking means along its outer surface disposed in a first position relative to the discharge opening and a second fastener strip with interengagable locking means disposed in a second position relative to the discharge opening. Most advantageously, the fastener strips each may have an array of identical mushroom-shaped locking elements along its outer surface, and the neck portion is foldable at least twice for causing the elements of the first and second fastener strips, located along opposite sides of the neck, to be brought into interlocking engagement to hold the neck portion in folded condition.
Other advantages and features of the invention will become apparent from the following specification when considered in view of the accompanying drawings.
As will be appreciated by referring to
Referring once again to
In the illustrated embodiment, the first fastener part 26 is associated with an outwardly facing surface of the closure strip 24 whereas the second fastener part 28 is associated with an outwardly facing surface of the opposite wall of the neck portion 18 and substantially conforms in size and shape with closure strip 24. More specifically, the first and second fastener parts 26 and 28 are advantageously complementary materials, one being carried by closure strip 24 across one wall of the neck portion and the other by the outer surface of the other wall of the neck portion which, when interlocked together, have a retention force for maintaining the neck in folded condition absent a disengagement force sufficient to overcome the retention force.
With the arrangement illustrated in
Referring now to
As will be appreciated,
The closure strips 22, 24; 122, 124; and 222, 224 are formed of any stiff but flexible polymeric material that is springlike and shape-recoverable to serve as bias members that return to straight, parallel and closed conditions in the absence of inwardly-directed finger pressure such as, for example, a polyolefin such as polypropylene. Since the springiness and shape-recoverability of the strips causes them to straighten when inwardly-directed finger pressure is reduced, a user, by varying such finger pressure, may easily and selectively control the rate of discharge of waste material through the discharge opening. Each strip is non-porous and non-absorbent, may be secured to the sidewalls 12 and 14 (preferably to the outer surfaces of those sidewalls) or may be imbedded in such sidewalls. Because such strips are stiff and non-absorbent, they are readily manipulated in use and are generally incapable of absorbing liquid and solid waste material.
In a preferred embodiment, the first and second fastener parts 26 and 28 each comprises a polypropylene fastener of the type sold under the trademark DUOTEC by G. Binder GmbH & Co. Holzgerlingen, Germany which is stated in product literature to work on the principle of interlocking mushroom elements. By using strips of this synthetic material for the first and second fastener parts 26 and 28, the discharge opening can be maintained in closed position (
Also, while the material utilized in the fastener sold under the DUOTEC trademark is polypropylene, it will be understood that other polymeric materials having similar properties may be employed.
The embodiment of
Since extension 29 does not engage fastener part 26 when the pouch neck is fully folded, the surface of the extension 29 may, if desired, be smooth and free of projections or interlockable elements.
As an alternative or addition to the embodiment of
Like strips 22 and 24, closure strips 322 and 324 may be formed of nylon, polypropylene or any other suitable polymeric material that renders the strips stiff but flexible, non-absorbent, and generally springlike in character. It is to be understood that closure strips 322 and 324 may be configured and function in the same manner as described in connection with the embodiments of
Immediately above closure strip 324, and similarly secured to the outer surface of sidewall 314, is the first fastener part 326 of a two-part fastener system. First part 326 takes the form of a fastener strip having outwardly-projecting locking elements which are preferably the mushroom-shaped elements described in connection with previous embodiments. In the illustration given, strips 326 and 234 are joined by an integral transversely-extending hinge 336. Perforations may be provided along the hinge line to facilitate folding of the neck portion, with the hinge 336 constituting the first fold line. It is to be understood, however, that while fastener strip 326 and closure strip 324 are shown to be connected to each other, they may instead be separate unconnected elements with the hinge line being formed solely by the line of material of sidewall 314 extending between the strips.
The second fastener part 328 of the two-part fastener system takes the form of a transverse strip with outwardly projecting interlocking elements secured to the outer surface of sidewall 312 well above the discharge opening 320 of the pouch. In the illustration given, fastener strip 328 is spaced above the discharge opening 320 a distance approximating the combined width of strips 322, 324 and 326, all three of which are of similar width. Whereas the embodiment of
In the description of the foregoing embodiments, it has been indicated generally each of the pouches are formed of flexible plastic film such that the sidewalls are joined or sealed together along their edges in a conventional manner. However, it will be understood that each of these embodiments could be formed in another manner while enjoying the benefits of the present invention, e.g., by using a continuous tubular plastic film rather than two or more films joined together.
In all embodiments of the invention, the drainable ostomy pouches are provided with flexible shape-recoverable and non-absorbent closure or stiffening strips extending transversely across each sidewall at or adjacent to the discharge opening at the end of the neck portions. Two or more folds are required to bring the first and second fastener parts into interlocking engagement. In all embodiments, such fastener parts are located along opposite sidewalls of the neck portion and have outwardly-projecting interlocking elements, ideally in the form of mushroom-shaped projections. The closure strips at the end of the neck portion facilitate opening of the discharge openings, to hold such openings in open condition. The closure strips also facilitate throttling and thereby controlling the rate of flow of waste material through the openings. The closure strips further define the folds as they occur and, when folding is substantially completed, help provide bulk and stiffness to the folded neck portion to assist a user in bringing the two fastener parts into interlocking engagement. The interlocking step is therefore the final step in a sequential folding operation with the interlocking occurring at the same time that the final fold is completed.
While in the foregoing there have been set forth preferred embodiments of the invention, it will be appreciated that the details herein given may be varied by those skilled in the art without departing from the true scope and spirit of the appended claims.
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|U.S. Classification||604/335, 4/144.3, 604/322, 4/144.2, 4/144.1, 604/327|
|International Classification||A61M1/00, A61F5/44, A47K11/00, A61F5/445|