Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-12-28
2003-07-15
Solis, Erick (Department: 3747)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S029000, C128S912000
Reexamination Certificate
active
06592558
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention generally relates to medical procedures and treatments. More specifically, the present invention relates to 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 solution bag is generally completely filled and ready for use after a sterilization procedure is performed. The dialysis solution is transferred from the solution bag to a patient during a peritoneal dialysis exchange procedure. A second empty bag is provided for draining liquid from the peritoneal cavity of the individual undergoing the procedure.
In conventional twin bag systems, the empty bag and the solution bag are interconnected by at least one set of tubing that ultimately connects to a patient catheter or dialysis bag/pouch. The tubing set provides fluid communication between an interior of the solution container and allows transfer of that solution from the interior of the container to a remote location, such as the patient or dialysis bag/pouch.
At the start of a typical cycle of CAPD, expended peritoneal dialysis solution is drained from the peritoneal cavity of the patient into the drain bag through the drain line of the tubing set. At that time, the fill line of the tubing set is closed using a conventional closure device such as a Borla clamp. After draining, the fill line is re-opened via the same Borla clamp to allow for the fill line to be “flushed.”
The intent of the “flush” procedure is to prevent infusion of air into the peritoneal cavity by priming that fill line with a new replacement peritoneal dialysis solution; and to serve as a microbial wash of each component of the set prior to administration of the new solution into the patient.
Following the “flush” procedure, the solution bag is filled with the new peritoneal dialysis solution via the same fill line. Once the filling procedure has been completed, the fill line is closed using another conventional closure device such as another Borla clamp. Because of the equipment involved and the multiple steps required to change the expended and new peritoneal dialysis solutions, the exchange procedure is often a complicated process for the patient to perform alone. Often, the patient requires the frequent assistance of professionally trained medical personnel. The procedure becomes even more difficult for those patients that are visually impaired.
Yet, for such patients to become ambulatory while receiving peritoneal dialysis, they must learn to operate the necessary solution exchange equipment properly by themselves. An extensive period of training for each patient by medical personnel to learn the exchange procedure is frequently required. In addition, such extensive training usually occurs while the individual is an in-patient at a hospital. Training in this manner greatly increases the healthcare cost for each CAPD patient.
A need, therefore, exists for an inexpensive and improved solution exchange device, method and system which simplifies the solution exchange procedure performed by a patient receiving continuous ambulatory peritoneal dialysis; and which reduces the training time required for each patient to learn that procedure.
SUMMARY OF THE INVENTION
The present invention provides improved devices, methods and systems for exchanging a solution. More specifically, the present invention provides improved devices, methods and systems which simplify the peritoneal dialysis solution exchange procedure performed by a CAPD patient.
To this end, the present invention includes an external integrated clamp device for temporarily closing a section of a fluid flow path comprising a series of integrated clamp portions operably communicating with one another in sequence and so arranged and constructed to temporarily close a fluid flow path defined by a fill tubing line and a drain tubing line each received within a channel of the clamp device, wherein the series of clamp portions comprises a first clamp portion for closing the fill tubing line when activated; a second clamp portion for re-opening the fill tubing line when activated; a third clamp portion for closing the drain tubing line when activated; and a fourth clamp portion for re-closing the fill line when activated.
In an embodiment, the clamp device is disposable.
In an embodiment, the first clamp portion is capable of locking into a fixed position by operably communicating with an integral first locking mechanism.
In an embodiment, the first locking mechanism comprises a lip capable of engaging a tab.
In an embodiment, the second clamp portion is capable of locking into a fixed position by operably communicating with an integral second locking mechanism.
In an embodiment, the second locking mechanism comprises a lip capable of engaging a tab.
In an embodiment, the third clamp portion is capable of locking into a fixed position by operably communicating with an integral third locking mechanism.
In an embodiment, the third locking mechanism comprises a lip capable of engaging a tab.
In an embodiment, the fourth clamp portion is capable of locking into a fixed position by operably communicating with an integral fourth locking mechanism.
In an embodiment, the fourth locking mechanism comprises a lip capable of engaging a tab.
In another embodiment of the present invention, a method of exchanging a first solution within a container having a fill tubing line and a drain tubing line with a second solution is provided. The method comprises providing an external integrated clamp device capable of receiving and operably communicating with a portion of each of the fill and drain tubing lines; draining the first solution from the container using a first clamp portion of the clamp device; flushing the fill tubing line with the second solution using a second clamp portion of the clamp device; filling the container with the second solution using a third clamp portion of the clamp device; and finishing the exchange of solutions using a fourth clamp portion of the clamp device.
In an embodiment of the method, the draining step further comprises closing the fill line while leaving open the drain line using the first clamp portion.
In an embodiment of the method, the flushing step further comprises re-opening the fill line using the second clamp portion.
In an embodiment of the method, the filling step further comprises closing the drain line while leaving open the fill line using the third clamp portion.
In an embodiment of the method, the finishing step further comprises re-closing the fill line using the fourth clamp portion.
In an embodiment of the method, the first and second solutions are each a peritoneal dialysis solution.
In an embodiment of the method, the method is self-administered by an individual.
In an embodiment of the method, the steps of the method are completed in sequence beginning with the draining step and ending with the finishing step.
In a further embodiment of the present invention, a solution exchange system is provided. The system comprises providing to an individual a first container having a first solution; a second container having a second solution; a third container; and at least one external integrated clamp device having a series of clamp portions capable of receiving a portion of each of a fill tubing line and a drain tubing line that are connected to the first, second and third containers; and activating the series of clamp portions in a sequence by the individual to exchange the first solution and second solutions.
In an embodiment of the system, the sequence comprises activating a first clamp portion of the clamp device by the individual to drain the first solution from the first container into the third container; activating a second clamp portion of the clamp device by the individual to flush at least one of the tubing lines with the second solution; activating a third clamp portion of the clamp device by the individual to fill the first container with the second solution from the second container; and ac
Barrett Robert M.
Baxter International Inc.
Choi Jane J.
Reagen Joseph P.
Solis Erick
LandOfFree
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