Title of Invention

MULTI CHAMBERED CAPD (CONTINUOUS AMBULATORY PERITONEAL DIALYSIS) BAG.

Abstract The invention relates to a multi chambered bag to be used in Continuous Ambulatory Peritoneal Dialysis system made out of two embossed sheets, radio frequency sealed, having three chambers, wherein the chambers are designed in such a way that no liquid is left over once the easy break-away valve is broken.
Full Text FIELD OF THE INVENTION :
The present invention relates to a multiple chambered bag to be used in Continuous Ambulatory Peritoneal Dialysis system, more specifically to a TRI CHOICE chambered bag having chambers A & B are provided with easily breakaway valves having the significant slope from both sides facilitating drainage of the solution from this respective chambers. Atleast three chambers of different volume capacity are provided to store the solution of different strength.
BACKGROUND OF THE INVENTION :
The patients afflicted with the loss functions have been treated by various methods since long time. Earlier, the patient had to be tied to the apparatus during the dialysis. With the advent of Continuous Ambulatory Peritoneal Dialysis the patient has more freedom of movement and is independent to handle the dialysis needs at home. Generally, the system of continuous ambulatory peritoneal "dialysis relies upon the delivery of dialysate from a flexible bag or the dialysate bag which the patient rolls up and wears during the time the dialysate is dwelling in the peritoneal cavity. Duringjhe dwell time the patient has complete freedom of movement even though the bag remains connected to the tubing inserted in the patient. After the dwell time is completed the patient allows the peritoneal cavity to drain with the used dialysate once again being collected into the flexible bag which the patient has unrolled. Once the collection is completed the patient disconnects the used bag and the contents. Then a new filled dialysate bag is connected once again and the cycle is repeated. Normally, in one day 4 to 5 such exchanges are required during dialysis process.

:3:
The aim of CAPD system is to provide a simple, easy, non-complicated and convenient system which can be used by the patient at home rather than going to the hospital or a doctor. It is also intended that the system allows the patient to make his daily needs at one filling from the delivery system rather than filling each bag separately to be used during the daily period.
The patient may need different formulation depending upon his condition. The
Tri Choice dialysis bag gives the liberty to the patient to have the desired formulation.
PRIOR ART :
U.S. Patent no. 3±8ZZ5D_descrJbesJa.muJtiple,bag.blood storage unit which allows the filling of a plurality of plastic containers with blood from main unit, the blood bag system disclosed has a hermatic seal between the main storage unit and the conduct means which feeds the smaller container. Such a hermatially sealed environment is not necessary in the home type delivery system, although an a aspetic connection and filling technique is requisite for peritoneal dialysis.
U.S. Patent no. 4326526 discloses a dialysate bag assembly having a plurality of compartments, each bag is removably positioned in one of those compartments. A filling feedline is detachably connected to each bag for providing dialystae from a source to each bag. The bags and the container are adapted to expand when the bags arefilled. Each bag includes an opening for emptying dialysate which has been delivered to the same from source.
- 3 -

: 4 :
The disadvantages of the dialysate bags which have been used for CAPD that no protective container assembly is provided. Also, the drainage of the dialysate is not complete thereby the solution is wasted. Lack of protecture sheet may result into leakage if the pressure increases inside the bag. The existing bags are made out of lay flat films. Due to this there is a lot of tackiness with the transfer bag and separation has to be achieved either by free or by use of chemicals. The conventional Tri Choice bag due to the flat bottom walls lacks in emptying the complete formulation, as such the desired formulation is not achieved.
The break-away valve provided is easy to be broken by simple twisting as is having the cone diameter greater than the cone inner diameter of the outlet part which avoids the break-away valve not to obstruct the flow of the formulation. Therefore, there always existed a need to provide a multichambered dialysate bag which has better strength enabling the compete drainage of the solution. It was required that the bag should be easy and convenient in use.
Accordingly the object of the present invention is to provide a Tri-choice bag for use in continuous ambulatory peritoneal dialysis which is simple and convenient.
Another object of the invention is to provide a dialysate bag with plurality of compartments which has uniform thickness so as to prevent leakage.
-k -

:5:
Yet another object of the invention is to provide a dialysate bag with plurality of compartments to facilitate complete drainage of the soution or the dialysate filled therein.
Still another object of the invention is to provide a dialysate bag with plurality of compartments in which each compartment can be filled with a different solution and required formulation can be achieved.
It is another object of this invention to provide a dialysate bag with plurality of compartments which is made of two soft PVC sheet radio frequency sealed so that there is no tackiness with the transfer bag.
It is another object of the present invention to provide unique breakaway valves to the compartments which can be easily operated by the patient keeping in mind that the patient does not have good manual strength or dextrity.
All the above and the other objects can be achieved by the present invention by a novel dialysate bag with plurality of compartments having breakaway valves to facilitate easy flow of solution in the main compartment. The Tri-choice dialysate bag comprises of three compartments A, B and C. Filling means are provided in each of the compartments. The dialysate bag is made of two solf PVC sheet radio frequency sealed giving complete RF sealing on the sides. Each compartment of the bag has means for emptying dialysate having been delivered to the same from the source. The tapering conical shape of the side compartments unables the complete solution to be mixed in the main compartment to give the desired formulation.

:6:
According to the present invention multichamber dialysate bag for continuous ambulatory peritoneal dialysis comprises atleast three chambers made out of two each of embossed sheet, radio frequency sealed, comprising comprising a main chamber for storing the dialsate provided with a medication port at the centre of the top rib, a chamaber provided at left hand corner of the main chamber radio frequency sealed, having a medication port at the top and a break-away valve diamaterically opposite to the medication port, a second chamber provided at the right hand corner RF sealed bag , having a medication port at the top and a break-away valve diamaterically opposite end of the chamber wherein a outlet port is provided at the bottom end of the main bag having inner diameter less than the diameter of the lower end of the break-away wall the bottom wall of the side chambers is conical in structure terminating at the outlet port.
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS :
Fig. 1 shows the conventional dialysate bag with plurality of chambers. Fig. 2 shows the Tri-choice dialysate bag as developed with plurality of compartments.
DETAILED DESCRIPTION OF THE INVENTION :
The present invention relates to a Tri-Choice dialysate bag which conveniently serves a CAPD patients needs. The invention is novel, simple and convenient to operate and can be easily handled by the patient without the help of doctor. Fig. 1 shows the unfilled dialysate bag of the prior art. The bag has plurality of compartments each separated by the other by plurality of internal walls.
- 6 -

:7:
The bag is made up of flat film. The compartments are having the horizontal bottom so that thesolution is not completely drained out when they are emptied out. With the result the correct formulation may not be achieved in the main chamber. The valves provided there to connect the chambers to the main chambers are not easily breakable and if they break sometimes the flow of the solution is not smooth. The dialysate bag is not provided with any protecture covering and there is nothing to support at the bottom of the bag. The valve often blocks the passage of the outlet port
Fig. 2 shows the bag of the present invention. The Tri-choice bag as the name suggests give the patient choice to fill three solutions at one time in this bag. The bag has three compartments A, B and C. Each of these compartments is provided with an inlet opening (1A, 1B and 1C) respectively so that the dialysate or any solution can be delivered into each of compartments during filling operation.
A medication port (3) is also provided for sampling / medication to the main compartment, upper compartment (A and B) are provided with outlet openings where two breakaway valves (4A, 4B) are fixed. These valves (4A, 4B) are novel, easy to handle and for unidirectional flow of the solution from the compartments A and B. Both the compartments (A,B) have a novel shape and bottom well is slightly curved providing significant slope to sides so that no solution remains into the compartments A and B once the valves (4A, 4B) are broken and the solution contained therein is completely drained out to compartment C so that a solution of appropriate formulation can be achieved in this compartment (C).


:8:

The solution from chamber C finally goes into peritoneal cavity of the patient throught out opening (5) for peritoneal dialysis and hence it will give appropriate dialysis results.
In this embodiment being described the preferred material for the dialysate bag is soft PVC sheet giving complete RF sealing on the sides. The bag is made out of two embosssed sheets of soft PVC in order to minimise tackiness or leaching of plastisizer into the dialysate. The strength of this bag is better than the existing dialysate bags as the thickness of the bag does not vary like in the case of lay flet films where the thickness variation is quite high resulting into leakage.
_ *
During use by a CAPD patient filled bag is customarily mounted so that outlet opening 5 faces downwardly for reliance on gravity feed of the dialysate in the bag. CAPD patient break the breakaway valves 4A, 4B one by one and this will make the solution of these compartments (A,B) flow into compartment C. An outlet tubing section is provided at the outlet opening (5) of the bag.


I CLAIM:
1. A multichamber dialysate bag for continuous peritoneal dialysis comprising atleast three chambers made out of two embossed sheets, radio frequency sealed, comprising a main chamber for storing the dialysate provided with a medication port at the center of the top rib, a first chamber provided at left hand corner of the main chamber radio frequency sealed having a medication port at the top and a break-away valve provided diametrically opposite to the medication port, a second chamber provided at the right hand corner of the main chamber, having a medication part at the top and a break-away valve diametrically opposite end of the chamber wherein a outlet port is provided at the bottom end of the main bag having inner diameter less than the diameter of the lower end of the break-away valve, the bottom wall of the side chambers is conical in structure terminating at the outlet port.
2. A multichamber bag for continuous ambulatory peritoneal dialysis as claimed in claim 1 wherein the break-away valve is fragile in nature and breakable easily from outside.
3. A dialysate bag for continuous ambulatory peritoneal dialysis as claimed in claim 2 wherein the break-away valve is snuggly fitted to the outlet of the each side chamber.
4. A dialysate bag for continuous ambulatory peritoneal dialysis as claimed in claim 1 wherein the said compartment are conical in shape having a outwards tapering side in the break-away valve.
9

5. As claimed in claim 5 wherein the said slope is between 120° - 160° at the outlet.

6. A multichamber dialysate bag as claimed in claim 1 wherein a concave
cavity is provided at the outer wall of the radio frequency wall well
circular groove to engage the tapering engaging the break-away valve.
7. A multichamber dialysate bag as claimed in claim 1, wherein the
double layer radio frequency sealed walls, render resistance i.e. the
outside pressure.
8. A multichamber dialysate bag as herein described well referred in the
accompanying drawings.
The invention relates to a multi chambered bag to be used in Continuous Ambulatory Peritoneal Dialysis system made out of two embossed sheets, radio frequency sealed, having three chambers, wherein the chambers are designed in such a way that no liquid is left over once the easy break-away valve is broken.

Documents:

00274-kol-2004 abstract.pdf

00274-kol-2004 claims.pdf

00274-kol-2004 correspondence.pdf

00274-kol-2004 description (complete).pdf

00274-kol-2004 drawings.pdf

00274-kol-2004 form-1.pdf

00274-kol-2004 form-18.pdf

00274-kol-2004 form-2.pdf

00274-kol-2004 letters patent.pdf

274-KOL-2004-CORRESPONDENCE 1.1.pdf

274-KOL-2004-FORM 13.pdf

274-KOL-2004-FORM-27.pdf

274-kol-2004-granted-abstract.pdf

274-kol-2004-granted-claims.pdf

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

274-kol-2004-granted-drawings.pdf

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

274-kol-2004-granted-specification.pdf

274-KOL-2004-PA.pdf


Patent Number 204057
Indian Patent Application Number 274/KOL/2004
PG Journal Number 09/2007
Publication Date 02-Mar-2007
Grant Date 02-Mar-2007
Date of Filing 28-May-2004
Name of Patentee LALIT MAHAJAN
Applicant Address 1-D,MANHAR MAHAL,4 BAKUL BAGAN ROW BEHIND LANSDOWNE MKT,KOLKATA 700025
Inventors:
# Inventor's Name Inventor's Address
1 LALIT MAHAJAN 1-D,MANHAR MAHAL,4 BAKUL BAGAN ROW BEHIND LANSDOWNE MKT,KOLKATA 700025
PCT International Classification Number N/A
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA