Ostomy appliance with integral closure

Details Ostomy appliance with integral closure Ostomy appliance with integral closure

2001-06-29

2003-04-08

Bennett, Henry (Department: 3743)

Surgery

Means and methods for collecting body fluids or waste material

Receptacle attached to or inserted within body to receive...

C604S317000

Reexamination Certificate

active

06544241

ABSTRACT:

BACKGROUND OF THE INVENTION
An ostomy is a surgical operation in which the flow of either the colon or small intestine, hereinafter the intestine, of the patient, hereinafter referred to as the ostomate, is redirected from the normal passageway and replaced with a portion of the intestine protruding from an orifice surgically formed in the abdomen. The portion of the intestine protruding from the surgically formed orifice is commonly referred to as a stoma in the medical community. The contents, i.e., fecal matter, of the intestine are then involuntarily discharged through the surgically formed orifice and collected by an ostomy appliance positioned over the stoma and attached to the abdomen of the ostomate.
An ostomy appliance conventionally includes a wafer and an ostomy pouch. The ostomy appliance may either be a one piece device or a two piece device, each of which includes a separate closure device to seal the bottom of the ostomy pouch. In the two piece device, the wafer is separate from the ostomy pouch and attached to the body of the ostomate. With the one piece device, the wafer is integral with the ostomy pouch. Regardless of whether the wafer is separate from or integral with the ostomy pouch, the wafer is positioned to be proximate the orifice surgically formed in the abdomen.
The wafer includes a flexible piece of synthetic material that adheres to the abdomen on a body side of the wafer and has an opening formed near the center thereof for the stoma to pass therethrough. The other side of the wafer includes a locking ring designed to engage the ostomy pouch, the locking ring encompassing the opening formed near the center of the wafer.
The ostomy pouch is used to collect the fecal matter discharged from the stoma through the opening in the wafer. The pouch is known to be formed from a synthetic material, such as rubber or plastic, and comprises two wall panels joined together along the top and both sides. One of the wall panels, that is, the wall panel closest to the abdomen of the ostomate, has an opening formed therein that also includes a locking ring configured to correspond to and lockingly mate with the locking ring of the wafer.
The opening and locking ring of the wall panel of the ostomy pouch closest to the abdomen of the ostomate is placed around the stoma and either attached directly to the body of the ostomate or to the wafer. The above-described arrangement results in the stoma being completely enclosed and sealed by the ostomy pouch and wafer. When the ostomy appliance is applied correctly to the ostomate, the ostomy pouch and wafer, in conjunction with a closure, permit the stoma to be completely enclosed, providing an air-tight, leak-proof, odor-proof seal. The closure is described in further detail below. In use, the ostomy pouch collects the fecal matter discharged from the stoma. When necessary, the ostomy pouch is then emptied of the collected contents.
Currently, there are two methods used by ostomates to empty the contents of the ostomy pouch. The first method used by ostomates includes a disposable ostomy pouch, which requires the ostomate to simply remove, discard and replace the entire ostomy pouch with a clean and empty disposable ostomy pouch. This type of ostomy pouch is commonly referred to as a non-drainable or single use device. Obviously, this method can become quite costly to the ostomate as well as the insurance provider, if there is one.
The second method, which is the more preferable and commonly used method as it is more cost effective and convenient, is to discharge the contents from the bottom of the open ended ostomy pouch. The opening is then dosed via the separate closure and the ostomy pouch reused. This type of ostomy pouch is commonly referred to as a drainable or multi use device.
There are several well known manners for sealing the opening formed in the bottom of the ostomy pouch. For example, U.S. Pat. Nos. 4,755,177 and 5,125,133 disclose the use of a folding bar and clamp, respectively, to seal the bottom opening of the ostomy pouch after the contents have been emptied. Because the ostomy appliance is worn by the ostomates at all times of the day, whatever manner is used to seal the bottom opening of the ostomy pouch closed, it is imperative for health, safety, and quality of life reasons that the closure be secure and tight, so as to permit the normal twisting, turning, and other such active motions performed by individuals during typical daily life. As such, there must be zero, or very little, risk in the closure becoming separated or broken, which would result in the unintentional release of the contents in the ostomy pouch.
There have been several attempts to solve the above-described problem of the bottom opening of the ostomy pouch from unintentionally opening and provide a secure, fluid and air-tight seal when normally dosed. However, each of the currently used closure techniques have particular disadvantages. Such disadvantages include techniques that are complicated to perform, folding bars and clamps that are difficult and costly to manufacture, the inability to properly seal the bottom opening of the ostomy pouch, the inability to of the ostomate to empty the full ostomy pouch without contacting the fecal matter contained therein, the inability of the ostomate to be comfortable enough to allow for normal daily activities, the inability to properly use the ostomy pouch due to the limited dexterity of the ostomates because of, for example, their advanced age, and danger of losing or dropping the clamp.
There are several drawbacks associated with the disposable ostomy pouches. For example, it is fairly well established in the medical community that disposable ostomy pouches are feasible only with colostomy ostomates because of the frequency of emptying the contents. In particular, while colostomy ostomates generally discard the pouch approximately once a day, illeostomy ostomates empty the contents of the pouches on average 5 times, or more, per day. As such, illeostomy ostomates have to replace the disposable pouches at least five times a day. Since ostomy pouches are costly, the use and disposal of several pouches per day is economically impractical. Although the frequency of colostomy ostomates having to dispose such pouches is less than illeostomy ostomates, even having to replace the pouches once a day can become costly. Additionally, unlike reusable ostomy pouches where only the contents are discarded, disposable pouches must be discarded in its entirety, thus not permitting disposal in a toilet. Rather, the disposable pouches, with the contents therein, must be disposed in a sealed receptacle bin in order to avoid the offensive odors associated with such and maintain cleanliness. Moreover, ostomates that use the disposable pouch encounter the problem of the replacement pouches not being compatible with the type of wafer already being used by the ostomate, in addition to the inconvenience of having to carry several replacement pouches with them at all times.
As mentioned above, currently, the more popular manner of sealing the bottom opening of the ostomy pouch is the damp similar to that disclosed in U.S. Pat. No. 5,125,133. As briefly explained above, there are several drawbacks to using the clamp as well as the aforementioned folding bar. For example, the United Ostomy Association has published reports indicating the average age of ostomates is 73 with 64% of all ostomates being in the 65-90 age group. Put simply, a majority, but nowhere near all, of ostomates are elderly.
Therefore, the typical ostomate is very likely to have limited dexterity. Typically, the use of a clamp requires the ostomate, to first sit on the toilet, place the ostomy pouch between his or her legs, lift the ostomy pouch with one hand so the contents are not placing pressure on the bottom opening that is sealed by the clamp, release the camp with the other hand by pinching a small release mechanism on the clamp, separate the clamp closure, place the clamp on a separate surface while still holding the ostomy pouch with one h

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