Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...
Reexamination Certificate
1998-07-31
2001-03-06
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Material introduced into and removed from body through...
C604S027000, C604S403000, C604S408000
Reexamination Certificate
active
06196991
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention generally relates to a dual-filled twin bag system, a package and a method for forming a package. More specifically, the present invention relates to a dual-fulled twin bag including dialysis solution in each bag wherein the twin bag is used for administering dialysis solution to a patient undergoing peritoneal dialysis.
It is, of course, generally known to store a dialysis solution in a flexible plastic bag for use in continuous ambulatory peritoneal dialysis (CAPD). The dialysis solution is transferred from the bag to a patient during a dialysis procedure. A second empty bag is provided for draining liquid from a peritoneal cavity of an individual undergoing peritoneal dialysis. In conventional twin bag systems, the empty bag and bag containing solution are interconnected by a set of tubing that attaches to a tubing set that ultimately connects to the patient catheter.
A solution bag, the bag containing the dialysis solution, is generally completely filled and ready for use after a sterilization procedure is performed. The sterilization procedure requires that the bag is oriented on a sterilizing tray or other device to sterilize the solution contained in the bag. Due to the volume of solution in the bag, sterilization is a time-consuming process. That is, due to the volume of solution creating a wide profile of the solution in the bag, heat penetration to effect complete sterilization of the solution, the bag and the tubing set is time-consuming.
To transport a solution bag, a drain bag, and a tubing set to a patient, the combination is placed in an overpouch. The overpouch is designed in order to accommodate the three components. However, it is often difficult and cumbersome to place the three components in an overpouch, particularly when the method is performed automatically. Namely, the tubing set often is tangled with the overpouch or the drain bag during placement into the overpouch. Furthermore, due to the profile obtained by filling a single solution bag, the overall profile of a conventional twin bag product within an overpouch tends to be bulky. This overall bulkiness of a conventional twin bag product itself further requires a correspondingly large shipping carton. Additionally, substantial storage space is required in the home or place at which an individual undergoes peritoneal dialysis. The amount of packaging also generates substantial trash to completely dispose of the product, including the packaging of the product, following use.
At the start of a typical cycle of CAPD, solution is drained from the peritoneal cavity into the drain bag through one line of the tubing set. After draining, a frangible in another line of the tubing set from the solution bag is broken to allow fluid communication between solution in the solution bag to be fed to the peritoneal cavity. Often, for physically or visually impaired patients, the frangibles are difficult to break. In addition, particulate matter from the breaking of the frangible may obstruct the fluid path. Moreover, use of a frangible in a tubing set may cause fibrin clots at the ends of the broken frangible parts.
A need, therefore, exists for an improved solution container and associated tubing set, particularly for use during a peritoneal dialysis procedure, which overcomes the deficiencies known in other systems that use a solution bag and a drain bag for administering a solution to a patient and subsequently drain the solution to a container.
SUMMARY OF THE INVENTION
The present invention relates to a dual-filled twin bag, a package including the bag and a method for forming a package for administering a solution. More specifically, the present invention relates to a twin-bag package, particularly useful for administering a solution used in a peritoneal dialysis procedure. The package is formed in such a manner to substantially reduce packaging size requirements and to simplify the packaging procedure.
To this end, the present invention provides a system having a solution bag with an interior holding a dialysis solution and a drain bag having an interior holding a dialysis solution. A tubing set including a length of tubing connects the solution bag and the drain bag.
In an embodiment, the dialysis solution in the solution bag is identical to the dialysis solution in the drain bag.
In an embodiment, the tubing set includes a coiled length of tubing.
In an embodiment, the solution bag and the drain bag are constructed of flexible plastic material.
In an embodiment, the tubing set includes a dialysis solution within the tubing set.
In an embodiment, the system has a first length of coiled tubing and a second length of coiled tubing wherein the first length and the second length are attached to form a multiple ring coil.
In an embodiment, a connector is attached to an end of the tubing set.
In an embodiment, a cap encloses an end of the connector attached to the end of the tubing set.
In an embodiment, the aforementioned cap is steam permeable.
In an embodiment, the solution bag and the drain bag are partially filled with the dialysis solution.
In an embodiment, the volumes of the dialysis solution in the solution bag and the drain bag are substantially equal.
In another embodiment of the present invention, a packaged system is provided. The packaged system has a first container having exterior walls defining an interior wherein the interior includes a solution. A second container having exterior walls defines an interior wherein the interior includes a solution. A tubing set is sandwiched between one of the exterior walls of the first container and one of the exterior walls of the second container wherein the tubing set connects the first container to the second container.
In an embodiment, the exterior walls of the first container and the second container sandwiching the tubing set are arranged such that the exterior walls are substantially flush with respect to each other.
In an embodiment, a third container has an interior constructed and arranged to completely encompass the first container, the second container and the tubing set.
In an embodiment, the tubing set includes a solution therein.
In an embodiment, the tubing set includes a coiled length of tubing.
In an embodiment, the first container and the second container are constructed from flexible materials.
In an embodiment, the solution of the first container is identical to the solution of the second container.
In an embodiment, the solution of the first container is a dialysis solution.
In an embodiment, the solutions are added to the first container and the second container during manufacture of the first container and the second container.
In an embodiment, the first container is a solution bag used during a dialysis procedure.
In an embodiment, the second container is a drain bag for use during a dialysis procedure.
In another embodiment of the present invention, a method is provided for forming a package for use during a peritoneal dialysis procedure. The method comprises the steps of: providing a first container defining an interior; providing a second container defining an interior; connecting the first container and the second container; and filling simultaneously and at least partially the interiors of the first container and the second container with a dialysis solution.
In an embodiment, a tubing set is provided including a length of tubing to connect the first container and the second container.
In an embodiment, a third container defining an interior is provided. The first container and the second container are placed in the interior of the third container.
In an embodiment, the tubing set is sandwiched between an exterior wall of the first container and an exterior wall of the second container.
In an embodiment, the first container and the second container include substantially equal amounts of the dialysis solution.
In an embodiment, a coiled length of tubing is provided to connect the first container and the second container.
In another embodiment, the first container and the second conta
Barrett Robert M.
Baxter International Inc.
Kelly Paula J. F.
Mattenson Charles R.
Rodriguez Cris L.
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