Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
2000-01-04
2002-11-26
Lewis, Aaron J. (Department: 3761)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
C600S029000
Reexamination Certificate
active
06485476
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 installed 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. It will further be appreciated in view of the disclosure herein that many of the various embodiments of the bolster portion of the new continent ostomy port can also be usefully applied to other known types of medical catheters, such as urinary catheters, endotracheal tubes, and the like, for example. For simplicity of discussion, however, the following usually discusses the new device in terms of use with or as an ostomy port device. The structure and use of the new device and portions thereof, are not to be considered limited by such discussion, as will be made clear throughout.
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. The new device also permits quick and facile access for irrigation and purging the ostomy without removing the port from the stoma, by use of specially designed adaptors in combination with the new COP, for example, to connect a gravity bag by tubing to the COP.
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 install 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 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 such as the new bolster concepts 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 installed 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 29 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. Thus, for example, when irrigating by the. conventional method the ostomate must carefully manually retain the irrigation tube connected to a cone in the stoma while introducing. fluids from a gravity bag in order to prevent spillage. Now the user of the new COP can connect a gravity bag via tubing adapted with connectors disclosed herein which are designed specifically for liquid-tight attachment to the COP and can then introduce irrigation fluid while having both hands free for other activities such as applying make-up or shaving.
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
Minasi John S.
Schneider James G.
von Dyck Peter M.
Blackwell Sanders Peper Martin LLP
Bogart Michael G.
Lewis Aaron J.
Zassi Medical Evolutions, Inc.
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