Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2002-02-20
2004-01-27
Hayes, Michael J. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06682507
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to continuous ambulatory peritoneal dialysis (CAPD) methods and systems and, more particularly, to a user wearable device such as a pouch or bag which provides a sterile environment for connecting a catheter to a fill-drain tube for feeding and draining dialysis fluid.
2. Background Art
Continuous ambulatory peritoneal dialysis (CAPD) is a method for performing dialysis for users with kidney failure. CAPD occurs in the user's peritoneal cavity using dialysis fluid. CAPD functions the same way kidneys do by constantly cleansing the blood as long as there is dialysis fluid in the peritoneal cavity. The dialysis fluid is left in the peritoneal cavity for several hours to collect waste from the blood. The used dialysis fluid is then drained from the peritoneal cavity into a drain bag. Fresh dialysis fluid from a fill bag is then supplied into the peritoneal cavity for the process to start over.
In order to exchange used and fresh dialysis fluid in the peritoneal cavity, a catheter tube (catheter) is permanently attached to the user. An interior end of the catheter is surgically inserted through the user's abdomen into the user's peritoneal cavity. An exterior end of the catheter extends out about four inches from the user's abdomen. The user connects the exterior end of the catheter to the fill bag via a fill-drain tube for receiving fresh dialysis fluid into the user's peritoneal cavity. Similarly, the user connects the exterior end of the catheter tube to the drain bag via the fill-drain tube for draining used dialysis fluid from the user's peritoneal cavity. Once the draining and filling operations are completed, the user disconnects the catheter from the fill-drain tube and seals the catheter.
The user must repeatedly exchange used and fresh dialysis fluid about four times a day for CAPD. Each exchange encompasses connecting the exterior end of the catheter tube to the fill-drain tube. A problem with each exchange is that the user must make the connections such that no germs or bacteria are introduced into the catheter tube. Germs or bacteria introduced into the catheter can enter the peritoneal cavity and cause infection. Repeated infections scar the peritoneal cavity and cause pain to the user.
In order to ensure that no germs or bacteria are introduced into the catheter, the user must perform what is known as the “aseptic technique” for making the connection between the catheter and the fill-drain tube. The aseptic connection technique includes making the connection between the catheter and the fill-drain tube in a closed environment such as a room. All doors, windows, and vents in the room must be closed and all fans in the room turned off in order to keep the air movement in the room at a minimum. The room should also be void of family activity and pets and occur in a spare bedroom or the like. In general, the aseptic connection technique requires appropriate environmental conditions which limit the mobility and flexibility of the user and require limitations on space resources.
What is needed is a portable device which effectively consolidates the size of a typical closed environment such as a spare bedroom into a much smaller size. Such a portable device would provide a sterile environment for connecting the catheter to the fill-drain tube for an exchange of used and fresh dialysis fluid even when the user is located in an environment unsuitable for the aseptic connection technique. As a result, a user wearing such a portable device while situated within a hostile environment, such as room where the windows are open or on a boat in a lake, could connect the dialysis tubes in order to perform an exchange in a sterile environment thereby satisfying the aseptic connection technique.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to provide a user wearable portable device such as a pouch or bag which provides a sterile environment for connecting the user's catheter to a fill-drain tube for performing an exchange of used and fresh dialysis fluid.
It is another object of the present invention to provide a user wearable pouch which provides a sterile environment for connecting the user's catheter to a fill-drain tube for performing an exchange of used and fresh dialysis fluid.
It is a further object of the present invention to provide a user wearable pouch having openings for inserting the user's catheter and a fill-drain tube into the interior of the pouch such that the user can connect the catheter to the fill-drain tube within the interior of the pouch for draining and feeding dialysis fluid in a sterile environment.
It is still another object of the present invention to provide a user wearable pouch having covered openings for inserting the user's catheter and a fill-drain tube into the interior of the pouch and having internally disposed hand covering elements in communication with the exterior of the pouch such that the user can insert his hands into the hand covering elements and connect the catheter to the fill-drain tube within the interior of the pouch for performing an exchange of used and fresh dialysis fluid in a sterile environment.
It is still a further object of the present invention to provide a user wearable pouch having covered openings for inserting a user's catheter and a fill-drain tube into respective sleeves extending into the interior of the pouch such that the user can expose the catheter and the fill-drain tube from the respective sleeves within the interior of the pouch and connect the catheter to the fill-drain tube within the interior of the pouch for performing an exchange of used and fresh dialysis fluid in a sterile environment.
It is still yet another object of the present invention to provide a user wearable pouch having a sterile interior operable for receiving a catheter and a fill-drain tube from sources exterior to the pouch such that the user can connect the catheter and the fill-drain tube in a sterile environment.
It is still yet a further object of the present invention to provide a user wearable pouch having internally disposed hand covering elements for enabling the user to insert his hands into the hand covering elements and connect the user's catheter to a fill-drain tube in the sterile interior of the pouch while manipulating the catheter and the fill-drain tube from a non-sterile environment external to the pouch.
Yet, it is still another object of the present invention to provide a peritoneal dialysis system having a user wearable pouch which provides a sterile environment for connecting the user's catheter to a fill-drain tube connected to a fill bag and a drain bag for performing an exchange of used and fresh dialysis fluid.
Yet, it is a further object of the present invention for providing a method for performing an exchange of used and fresh dialysis fluid by connecting a user's catheter to a fill-drain tube within the interior of a user wearable portable device.
In carrying out the above objects and other objects, the present invention provides a user wearable device for connecting a catheter of the user to a fill-drain tube for performing an exchange of dialysis fluid. The device includes a pouch having an interior formed by connected front and back sides. The front side of the pouch has an exposeable opening for inserting a fill-drain tube into the interior of the pouch. The back side of the pouch has an exposeable opening for inserting a catheter into the interior of the pouch.
The device may include at least one internally disposed hand covering element in communication with the exterior of the pouch for receiving at least one of the user's hands in order to enable the user to connect the catheter to the fill-drain tube within the interior of the pouch for performing an exchange of dialysis fluid. The at least one internally disposed hand covering element may include a pair of mittens.
A fill-drain tube sleeve extending
Brooks & Kushman P.C.
Doug's Kangaroo Pouch, LLC
Hayes Michael J.
Kontos Lina R
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