Title of Invention	CAPD (CONTINUOS AMBULATORY PERITONEAL DIALYSIS) BAG
Abstract	The present invention relates to a CAPD bag system for continuous ambulatory peritoneal dialysis system comprising a primary bag made out of a pair from SPVC medical grade sheet, RF sealed along all its four sides four provided with a medication port, tube clips, special tubing connecting the primary bag to the drainage bag via the Y connector and a connector.

Full Text

:2: FIELD OF THE INVENTION The present invention relates to a CAPD (Continuous Ambulatory Peritoneal Dialysis) Bag. More particularly the present invention relates to a novel CAPD bag system in which the primary bag is made out of from a pair of Soft PVC Sheet, RF sealed from all four sides and is having a novel medication port, a reinforced Y tubing, a special connector with hood ribs support, a drainage bag provided with a novel sampling port free of tackiness. The system has novel breakaway valve and is so designed that there are no chances of contamination of fluid and convenient for the patient to remain infection free. BACKGROUND OF THE INVENTION Continuous ambulatory peritoneal dialysis is performed for removal of toxic substances and metabolites normally received by the kidney. It is one of the most widely used method of treating the patients those possess kidney disorder. It is preferred method of treating the kidney patients over hemodialysis or intermittent peritoneal dialysis. The continuous ambulatory peritoneal dialysis (CAPD) procedure is intended to be a patients self case technique and is directed towards more freedom of movement to the patient during dialysis. CAPD generally aids in maintaining the fluid and electrolyte balance in the human body. The process of CAPD is accomplished by percutaneous or surgical implementation of a catheter in patients abdomen. In CAPD system, a dialysis :3: solution is introduced in the peritoneal cavity of the patient, allowed to remain there for few hours and then drained from the peritoneal cavity of e patient The basic principle of the dialysis is creating osmotic gradient across the peritoneal membrane. The dextrose in the CAPD solution makes it hypermolar which assists in the transfer of the toxic substances and metabolites present in high concentration in the blood plasma across the peritoneal membrane into the dialysite. The solution normally in CAPD bag does not contain potassium but the same can be added through medication port in case it is required. To achieve the above the several steps involved are connecting a dialysis solution to catheter connected to the patients peritoneal cavity in clamping the tubing between dialysis solution container and the patients peritoneal cavity to allow the dialysis solution to flow from he container to peritoneal cavity thereafter reclamping the tubing, allowing the dialysis solution to remain within the patients. Peritoneal cavity for desired hours, in clamping the tubing and draining the solutions from the patients peritoneal cavity back to dialysis solution container, disconnecting the dialysis solution container from the catheter tube and connecting to the catheter tube a fresh dialysis solution container and repeating the above steps again. US Patent No. 187008 describes equipment for continuous ambulatory peritoneal dialysis. The equipment includes a flexible foldable plastic dialysis solution container having a transfer port A flexible tube having a line connector at its distal end extending from the transfer port for connecting to a liner connector carried by the :4: patients tube. The flexible tube carries a frangible member which normally blocks fluid flow but permits fluid flow after the frangible member is broken. A particulate filter and normally operable clamp are in series with the flexible tube. Peritoneal dialysis is carried out by connecting the liner connector from a fresh dialysis solution bag to the patient's tube liner connector breaking the frangible member and opening the clamp on the flexible tubing. After the dialysis solution is introduced into patients peritoneal cavity and remains there for a predetermined time the solution is drained back into the flexible bag, the liner connector are disconnected, US Patent no. 5037385 describes a wholly transplantable continuous ambulatory peritoneal dialysis system comprising a first port including tubing and second port including a pump and a further tubing serially interconnected for location as a shunt for a flow path for solution. US Patent no. 5642201 describes a peritoneal dialysis system of the continuous flow type which includes reverse osmosis unit which prepares sterilized and filtered water, dialysis concentrate and dextrose to provide dialysis fluid in dialysis production unit. US Patent no. 6245038 describes method, apparatus and kits for performing peritoneal dialysis. In this patent subcutaneous and transcutaneous systems are described. US Patent no. 629066 describes periotoneal dialysis apparatus including holder device for holding a container for dialysis fluid to be introduced into peritoneal chamber of :5: subject, a catheter device insertable through abdominal wall and a conduit device fluidly connecting the container to the catheter device. The apparatus has an agitator to enhance the rate of solute removal. US Patent no. 6497676 describes an automated peritoneal dialysis system and method for monitoring and controlling automated peritoneal dialysis therapy based on intra peritoneal process measured at a peritoneal near the end of patients catheter during fill, dwell and drain phase of automated peritoneal dialysis therapy. The existing peritoneal dialysis systems, the dialysis bags provided in the systems are not leakage proof. The existing dialysis bag assemblies are such that the shape of the dialysate bag does not allow total drainage of the diaiysate thus resulting in wastage of the solution. Further no protective container assembly is provided in the system. The breakaway valves used and designed for use in continuous ambulatory peritoneal dialysis system are not easily breakable. Also there is no surety that the flow of the fluid will be smooth and continuous after breaking the breakaway valve. Very often the breakaway valves blocks the flow of fluid due to the broken parts coming in the way. The medication ports used in the system and apparatus so far for continuous ambulatory peritoneal dialysis are liable to get contaminated due to the latex being touched by hand. The needle also puncture the surface of the port. Also in some conditions if not used with due care there could be outflow or leakage of the fluid from the medication port. During the connections and disconnection of the transfer set from :6: the dralysate assembly, the touch of the human hands can cause contamination and infection in the patient. Therefore there always existed a need to improve upon the existing continuous ambulatory peritoneal dialysis system and apparatus which does not have the above mentioned drawbacks. Accordingly it is the object of the present invention to provide a CAPD bag system Which has a protective container assembly. It is another object of the present invention to provide a CAPD bag system which is easy to handle and safe for the patient. It is yet another object of the present invention to provide a CAPD bag system which is disposable after single use. It is still another object of the present invention to proivde a CAPD bag system in which there are no chances of contamination of fluid system,. It is the other object of the present invention to provide an improved CAPD bag system which is designed to permit significant freedom of movement to the patient during dialysis. It is another object of the present invention to provide a novel dialysate for use in continuous ambulatory peritoneal dialysis having specially designed breakaway :7: valves and medication port, novel connecting means a simple and good tubing set carried by the solution container and solution container are made of special grade filter. It is an object of the present invention to provide a CAPD bag system in which the connector maintains the integrity of the connections and alleviates contamination. It is yet other object of the present invention to provide a CAPD bag system with Y connector which gives reinforcement to the tubing. The other embodiment of the invention is to provide a CAPD bag system which has a novel medication port and having a breakaway valve which are easy to break, without blocking the passage. A CAPD bag system having a drainage bag. The drainage bag is free of tackiness, with easy opening for fluid flowing and filling. According to the other embodment, the CAPD bag system, drainage bag has one side mirror sheet and other side embossed sheet. A CAPD bag system thus comprises a Primary bag which is made of plastic sheet, RF sealed, having a novel medication port. The dialysate bag is coupled with a flexible special tubing. The tubing of the dilaysate bag and the drainage bag is provided with tube clips. The dialysate bag is connected to the connector through a breakaway valve :8: using tubing and is attached to a drainage bag required for draining the used fluid after the dialysis has been completed. The breakaway valve is followed by a Y connector or tubing which is connected is a specially designed connector to cover the entire threading of the transfer set. The connector is supported with hood ribs support and has a cap with a handle. The hole of the central tube of the connector is smaller in diameter to provide free flow of the liquid. The drainage bag is RF sealed all the four sides and has mirror sheet on one side and embossed sheet on the other. According to the present invention a Continuous Ambulatory Peritoneal Dialysis bag (CAPD) comprises a primary bag made out from a pair of soft PVC sheets radio frequency around all its edges, characterized in that a medication/sampling port for infusion of the solution is provided at the central portion of the primary bag, a flexible tubing connected to the primary bag through a connector comprising hood ribs support fitted with a cap and a handle, through a breakaway valve wherein a drain tube is connected to the said connector through a tube clip and a drainage bag snuggly fitted to the tail edge of the drain tube. The above invention will become more apparent when considered in the light of he following accompanying drawings. BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS Fig. 1 shows the schematic diagram of the CAPD bag of the present invention. :9: DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS The present invention relates to a CAPD bag system for continuous ambulatory peritoneal dialysis and consists of an integrated closed system. As shown in Fig. 1, the CAPD bag consists of a primary bag (1) which is made out of SPVC medical grade film. The primary bag (1) is RF sealed on all four sides. The primary bag is provided with a medication port (2). Through the medication port (2) additional fluids or medication may be introduced in the primary bag (1). The primary bag (1) is connected to our flexible tubing (3) in additions a manually operable tube clip (7) is connected in series with the flexible tube (3). The primary bag (1) is connected to a Y connector (4) with a breakaway valve (5). The Y connector (4) is provided with extra thickness of the material on all the three arms. The Y connector (4) is asymmetric and has a connector (6) on the distal end. The connector (6) consists of a cylindrical hood (8) and is supported by the hood support. The connector (6) is provided with a cap (9) with a handle (1) and is so designed that by holding the end of the handle (10) and by following the same out of the connector (6) the head of the connector (6) is uncapped. The cap (9) is made of medical grade latex. The cylindrical hood (8) of the connector (6) covers the entire threading of the transfer set during dialysis. The transfer set connects the CAPD bag system to the catheter of the patient. The connector has central tubular portion which is tapered to give free flow to the fluid. One arm of the Y connector (4) is connected to the drain tube. A tube clip (11) which is manually operable is put in series with the flexible drain tube (12). The drain tube (12) opens with the drainage bag (13). The drainage bag (13) is the collection of the used fluid : 10: after the dialysis has been completed. The drainage bag (13) is also made of SPVC medical grade film and RF sealed on four sides. It has a novel sampling port (14) comprising of two ports male and female. Both these ports have matching threading the female component is cup shaped in the top half and cylindrical at the bottom half. A gasket is fitted inside the female cup and then the male component is fitted into it. The sampling port when penetrated by needle through latex gasket does not drainage the vial and fluid is withdrawn from the bag (13) without any chances of contamination. In operation the CARD bag system is connected to the catheter through transfer set, the peritoneal cavity of the patient is initiafly emptied by removal of the peritoneal fluid into the drainage bag (13) by gravity. After it is completely drained out the CARD solution is infused in peritoneal cavity. After infusion the CAPD bag system is disconnected from the transfer set. The transfer set is closed using a transfer set cap containing a foam soaked with disinfectant. The dialysate stays for 4-5 hours in peritoneal cavity and during this time transfer of toxic substances and metabolites later flows to the dialysate. The entire process constitute an exchange procedure. The connector of the present invention covers the entire threading of the transfer set so that no contamination takes place during connection or disconnection of the transfer set during exchange procedure. The CAPD bag system is for single use and is so designed that an infection free dialysis can be carried out. 11 I CLAIM 1. A Continuous Ambulatory Peritoneal Dialysis bag (CAPD) comprising a primary bag made out from a pair of soft PVC sheets radio frequency around all its edges, characterized in that a medication/sampling port for infusion of the solution is provided at the central portion of the primary bag, a flexible tubing connected to the primary bag through a connector comprising hood ribs support fitted with a cap and a handle, through a break-away valve wherein a drain tube is connected to the said connector through a tube clip and a drainage bag snuggly fitted to the tail edge of the drain tube. 2. A CAPD bag as claimed in claim 1, wherein the said primary bag is made out of a pair of novel soft SPVC medical grade film, radio frequency sealed around its all edges, provided with a hanger hole at its top end. 3. A CAPD bag as claimed in claim 1, wherein the said medication/sampling port comprises a threaded male and female component having a hex cavity, a latex gasket fitted in the female component. 4. A CAPD bag as claimed in claim 1, wherein the flexible tubing comprises a manually operable tube clip. 5. A CAPD bag as claimed in claim 1, wherein the medication/sampling port is adopted to be free of tackiness. 6. A CAPD bag as claimed in claim 1, wherein the drainage bag comprises a mirror sheet and embossed sheet RF sealed together. 7. A CAPD bag as herein described with reference to the accompanying drawing. The present invention relates to a CAPD bag system for continuous ambulatory peritoneal dialysis system comprising a primary bag made out of a pair from SPVC medical grade sheet, RF sealed along all its four sides four provided with a medication port, tube clips, special tubing connecting the primary bag to the drainage bag via the Y connector and a connector.

Documents:

00335-kol-2004-abstract.pdf

00335-kol-2004-claims.pdf

00335-kol-2004-correspondence.pdf

00335-kol-2004-description(complete).pdf

00335-kol-2004-drawings.pdf

00335-kol-2004-form-1.pdf

00335-kol-2004-form-13.pdf

00335-kol-2004-form-18.pdf

00335-kol-2004-form-2.pdf

00335-kol-2004-form-26.pdf

00335-kol-2004-form-3.pdf

00335-kol-2004-letters patent.pdf

335-KOL-2004-CORRESPONDENCE 1.1.pdf

335-KOL-2004-FORM 13.pdf

335-KOL-2004-FORM-27.pdf

335-kol-2004-granted-abstract.pdf

335-kol-2004-granted-claims.pdf

335-kol-2004-granted-description (complete).pdf

335-kol-2004-granted-drawings.pdf

335-kol-2004-granted-form 2.pdf

335-kol-2004-granted-specification.pdf

335-KOL-2004-PA.pdf