Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
1999-07-28
2003-07-22
Casler, Brian L. (Department: 3763)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
Reexamination Certificate
active
06595971
ABSTRACT:
BACKGROUND AND SUMMARY OF THE INVENTION
Field of the Invention
The present invention relates to the field of ostomy-related devices, and, more particularly, to a system for use by individuals having a stoma or internal reservoir, including those people having a self-retaining ostomy port of the type described briefly below, and in further detail in our pending related U.S. patent application Ser. No. 09/030,685, which self-retaining continent ostomy port can be inserted into a stoma and secured for long-term placement. The new ostomy irrigation system, having a pulsating pump and specialized adapters, permits hands-free drainage and irrigation of the ostomy, as well as portability and connectability to various types of ports and direct delivery of medicaments or other substances through the stoma site, as well as permitting the user to ambulate between the infusion and evacuation steps of the irrigation process.
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 surgically created internal reservoirs. For simplicity of discussion throughout this document, the term “stoma” will be understood to include stomas emanating from internal reservoir structures as well as normal, intact bowel. Ostomates, individuals who have a stoma, have historically been faced with a variety of problems not ordinarily experienced by the general (non-ostomate) public. Many of these problems are associated with the appliances (i.e. pouches/bags) these individuals are required to wear to manage their surgically created incontinence. These bags surround the outlet to the surgically created stoma and are attached to the individual's abdomen via adhesives, belts or tapes. They provide a container into which fecal matter can continuously drain. Problems associated with these bags include seepage of intestinal gas and waste, such as mucous and liquid and solid fecal material from around the pouch seal. Such seepage not only causes unpleasant and embarrassing odors, but also leads to health and hygiene problems, such as fecal soiling, skin irritation or worse, necrosis of the tissue surrounding the stoma site. This tissue necrosis creates the additional problems of increased expense and increased health risks as a result of the treatment or surgical intervention required to repair the damaged tissue. The bag material can also make bothersome noises during movement as the bag rubs against the user's clothing. For many ostomates, the bulk of the bag beneath clothing also presents a problem. All these negative consequences of having an ostomy can deter social activities of all types, and especially any which are more physical in nature. Frequently, isolation and depression result.
Despite the problems associated with conventional ostomy bags, it is to be understood that the new ostomy ports described herein are capable of accepting an ostomy bag or other accessories adapted to connect to the opening of the new ostomy ports, preferably in detenting and at least substantially leak-proof fashion. Purposes for using a bag with the new ostomy ports include but are not limited to: providing a new user a method of gradually weaning themselves from the use of an ostomy bag and providing a method of temporary collection for a user with a high output ostomy, in instances when they will not be able to get to a toilet facility for an extended period of time.
Additional problems with conventional ostomy systems include allergic reactions to the bag material and/or adhesives used to affix the bag to the abdomen. Both problems can be eliminated by the proposed system which eliminates the long-term need to wear an ostomy bag. It is conceivable, however, that the ostomy ports described herein which are intended primarily to be used without adhesives, could in fact be used with an adhesive, particularly if the new ports are made and used without the preferred internal retention bolster or other structure for maintaining the port in normal operative position.
The known commercial art has made a variety of attempts to address these problems, without clinical success. Although the majority of ostomates use bags to manage body wastes, a number of barrier devices have been developed which essentially completely plug or occlude the stoma until the user is ready to evacuate. Total occlusion of the colon results in a number of problems including the build-up of gases resulting in abdominal cramping, leakage around the device, extrusion of the device from the ostomy and pressure necrosis of the intrastomal intestinal tissue. These occlusive devices, for the most part, have not been clinically viable and many have required revisionary surgery in order to function properly. By contrast, the new continent ostomy port which can be placed in existing stomas without surgical intervention addresses all of these problems. The new continent ostomy port continually filters and vents intestinal gas, while preventing the escape of fecal matter. It has a “bioresponsive” internal retention bolster that adjusts to changes in intracolonic pressure to simultaneously prevent leakage, tissue necrosis and device extrusion.
Many of these previously attempted and presently marketed barrier devices required the device to be completely removed from the stoma in order for the individual to purge (evacuate) and/or irrigate the bowel. The new continent ostomy port permits quick and facile access for irrigating and/or purging the ostomy without removing the port from the stoma or internal reservoir. These necessary procedures, irrigation and purging, as will be made clear hereafter, are made easier and more convenient by use of the system of the present invention.
Because of limitations of the presently marketed ostomy irrigation sets (i.e. a gravity bag with an attached tubing set that terminates in a conical adapter that interfaces with the stoma), some of the shortcomings of the conventional ostomy irrigation process are the time consuming nature of the process (60-90 min.), the confinement of the user to one place (i.e. the user cannot ambulate) during the process and the requirement that the user hold the cone in place during the infusion portion of the process. Water temperature problems also exist with known systems, as discussed further hereafter.
SUMMARY OF THE INVENTION
The new ostomy irrigation system, particularly when used with the described ostomy port, facilitates long-term port access and helps to eliminate the need to continuously wear an ostomy bag and/or the need for cumbersome and lengthy daily irrigation procedures. The long-term access port, described briefly herein (and more completely described and shown in our copending U.S. patent application entitled, Continent Ostomy Port, the specification of which is incorporated herein by reference, in its entirety), prevents leakage sometimes associated with the use of known colostomy management methods because the connection between the new ostomy management system and the user is via this new locking, sealing port which mates internally with the stoma. By contrast, known ostomy management systems conventionally are affixed directly to the stoma site by adhesives or belts, thus permitting leakage because a complete seal at the site of device user interface is not always possible.
The ostomy irrigation system of the present invention is adapted for convenient and facile use in both of the above situations, whether the ostomate is using a conventional ostomy appliance or the new continent ostomy port. The new port device is adapted to be selectively connected to a pouch or tube, 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 bei
Schneider James G.
von Dyck Peter M.
Blackwell Sanders Peper Martin LLP
Casler Brian L.
Lam Ann Y
Zassi Medical Evolutions, Inc.
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