Pad for use with a continent ostomy port

Details Pad for use with a continent ostomy port Pad for use with a continent ostomy port

1999-10-19

2002-02-26

Lewis, Kim M. (Department: 3761)

Surgery

Means and methods for collecting body fluids or waste material

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

C604S336000, C604S332000

Reexamination Certificate

active

06350255

ABSTRACT:

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 r

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