WO1996039207A1

WO1996039207A1 - Device for continuous peritoneal dialysis

Info

Publication number: WO1996039207A1
Application number: PCT/EP1996/002406
Authority: WO
Inventors: Diego Furlan
Original assignee: Haemopharm Industry Ag
Priority date: 1995-06-06
Filing date: 1996-05-31
Publication date: 1996-12-12
Also published as: IT1275311B; ITMI951172A1; EP0831944A1; KR19990022210A; CA2223255A1; ITMI951172A0; JPH11506370A

Abstract

A device for continuous ambulatory peritoneal dialysis comprises a bag (1) for containing a dialysis liquid which can be coupled to a catheter (5) permanently attached to a patient (6). A first tube (2) and a second tube (3) extend from the bag and can be connected to the catheter (5) and to a drain container (8), respectively. The first and the second tube (2, 3) are connected to a portion (10) of the bag (1) which can be separated hydraulically from the remainder of the bag (1).

Description

"Device for continuous peritoneal dialysis". * * * * * The present invention relates to a device for continuous peritoneal dialysis. Among the peritoneal dialysis techniques for the treatment of uraemic patients, continuous ambulatory peritoneal dialysis (CAPD) is of great importance. .

This technique, devised in 1975, consists in connecting a plastic container with approximately two litres of a dialysis liquid (a solution with added glucose normally isosmotic with plasma) to a peritoneal catheter, permanently attached to the patient, by means of a short plastic tube with appropriate connectors at its two ends. After connection, the dialysis liquid fills the peritoneal cavity, where the blood which surrounds the peritoneal membrane exchanges the substances present in the aqueous phase and transfers the uraemic toxins to the dialysis Liquid. After an appropriate Lapse of time, the peritoneal cavity is emptied.

For effective depuration of the patient, the aforementioned procedure has to be repeated daily at least four times during the day. This exposes the patient to the risk that, during the manoeuvres for permanent catheter connection to the bag, pathogenic agents may be introduced into the peritoneal cavity, causing the onset of bacterial peritonitis. In order to reduce the frequency of infections a connection system, known as a "Y-set", has been introduced which provides for the connection between the patient and the bag containing the dialysis Liquid to be made by means of a Y-connector, the three arms whereof are connected to the patient's catheter, the bag of dialysis liquid and a drainage collector respectively. Normally the Y-connector is filled with disinfectant, typically "Amuchina". In order to exchange the dialysis liquid, the patient has to make an impromptu connection between the Y-connector and the bag of dialysis liquid, or between the Y-connector and the permanent catheter, or both. The first operation which the patient performs is in any case that of emptying the abdomen of the liquid present therein which has to be replaced (a technique known as "flush before fill"). During emptying of the abdomen, performed with the connection open between abdomen and drain and the connection between abdomen and bag closed, the Y-connector is also emptied of the disinfectant present therein. The efficacy of this system in preventing bacterial peritonitis has for example been stated in the article "Peritonitis Prevention in Continuous Ambulatory Peritoneal Dialysis: Long-Term Efficacy of a Y-connector and

Disinfectant", Cantaluppi et al., Peritonitis Dialysis Bulletin 1986, 6:58.

A preferred variant of the above system is the so-called "double bag" one which, in addition to the bag containing the dialysis liquid, comprises a second bag used for draining the liquid present in the peritoneal cavity. In this variant of the system of connection with a Y-connector the patient has to make a single connection, that of the Y-connector to the catheter. The tube which stretches from the dialysis liquid bag to the Y-connector is kept closed, for example by means of a clip.

After having made the connection, the patient drains the liquid contained in the peritoneal cavity which, passing through the connection point, washes the Latter. The patient then opens the dialysis liquid feed tube. The probability of contamination of the dialysis Liquid is considerably reduced both thanks to the fact that the number of connections is reduced, and thanks to the washing of the connection point performed by the drained liquid. In this variant, the disinfectant may not be provided, or it may only be provided in the point of connection to the catheter.

The above system of connection with a Y-connector, also in its preferred variant with a double bag, nevertheless has the disadvantage of consisting of at least three separate parts, namely the bag for the dialysis liquid, the drain bag and the Y-connector, which have to be manufactured separately and must then be assembled by hand. This Leads to an increase in the production costs and the probability of contamination of the dialysis liquid, which contamination is due both to the use of toxic bonding agents and to the assembly environment. In view of the state of the art described, the object of the present invention is that of providing a device for continuous ambulatory peritoneal dialysis, which solves the abovementioned problems.

In accordance with the present invention, this object is achieved thanks to a device for continuous ambulatorial peritoneal dialysis comprising a bag for containing a dialysis Liquid which can be coupled to a catheter permanently attached to a patient, characterised in that a first tube and a second tube extend from said bag and which can be coupled respectively to said catheter and to a drain container, said first and second tubes being connected to a portion of the bag which can be separated hydraulically from the remaining of the bag.

In the present invention the Y-connector of the devices according to the known art is no Longer necessary, being replaced by a small portion of the bag itself which, during A -

emptying of the liquid present in the peritoneal cavity, is isolated hydrauL cally, for example by means of a clip, from the remaining of the same bag. The Liquid present in the peritoneal cavity passes into the first tube, into the bag portion, into the second tube and then is drained.

Subsequently, again by a clip, the second tube is closed while the hydraulic connection of the bag to the two tubes and the remaining of the bag is opened, so that the dialysis Liquid contained in the bag can be transferred into the abdomen of the patient in order to perform the clinical action for which it is intended.

The connection device according to the invention has low production costs, in that it does not require the manufacture of separate parts which then have to be assembled by hand, and also reduces the possibility of contamination caused by the actual assembly of the various parts which make up the devices according to the known art.

The features of the present invention will be made clearer from the following detailed description of some of its embodiments, illustrated by way of non-limiting examples in the accompanying drawings, in which:

Figure 1 is a schematic non-scale representation of a device for ambulatory peritoneal dialysis according to a first embodiment of the invention, in a first operative phase; Figure 2 is similar to Figure 1, but refers to a second operative phase;

Figure 3 shows a bag containing the dialysis Liquid according to a second embodiment of the invention;

Figure 4 shows a bag according to a third embodiment of the invention; Figure 5 shows a bag according to a fourth embodiment of the invention, in a first non-operative condition;

Figure 6 shows the bag of Figure 5 in a second operative condition. With reference to Figure 1, the device according to the present invention comprises a bag 1 containing a dialysis liquid. The bag 1 is a normal bag formed by two sheets of transparent and flexible plastic material sealed one to the other at the edges. The bag 1 is provided with two flexible tubes 2 and 3, for feed and drainage respectively. The feed tube 2 is fitted with a connector A for the connection to a peritoneal catheter 5 permanently attached to a patient 6. The catheter 5 is provided with a device for cutting off the Liquid 7, typically a so-called "roller". The drain tube 3 is connected to a drain container, for example a chamber-pot 8. The drain device could also be formed by a second bag (not shown) connected to the drain tube 3.

The feed tube 2 and the drain tube 3 are connected to the interior of the bag 1 in two respective adjacent positions, for example near a corner of the bag 1. In this way, by means of a clip schematically denoted by 9, it is possible to isolate hydraulically from the remaining of the bag 1 a small corner portion 10 of the bag itself, thus forming a drain route which, in addition to the catheter 5, comprises the feed tube 2, the portion 10 of the bag and the drain tube 3.

Normally, before use, the bag 1 is in a container (not shown) which preserves the sterility thereof. When the bag has to be used, it is removed from the abovementioned container and its intact state and the clearness of the dialysis Liquid contained therein are checked. The bag is then rested on a work surface, positioned in front of the patient. The clip 9 present on the bag is then closed to isolate hydraulically the bag portion 10 from the remaining of the bag 1. The two tubes 2 and 3 are then unrolled, and the feed tube 2 is connected, by means of the connector 4, to the catheter 5 attached to the patient. A plug, not shown, required for.closing said tube 3, is removed from the drain tube 2 and is then inserted in the drain container 8, normally placed on the floor. In the case wherein the drain bag is already connected to the drain tube 3, the bag is placed on the floor.

The cut-off device 7 on the catheter is then opened, and thus the phase of draining of the liquid contained in the peritoneal cavity begins. The liquid passes through the connector 4, washing it and if necessary supplying a disinfectant, enters the bag portion 10, flows into the drain tube 3 and then drains into the container 8.

Once drainage has been completed, the drain tube 3 is closed by a clip 11, as near to the engagement with the bag 1 as possible. The clip 9 is then opened so as to connect the tube 2 to the remaining of the bag 1 containing the dialysis Liquid, the bag 1 is hung from a special stand, and thus the phase of feeding said liquid into the peritoneal cavity of the patient begins. At the end of the feeding phase, the cut-off device 7 on the catheter 5 of the patient is closed, and the feed tube 2 is disconnected from the catheter 5.

An additional advantage of the device according to the invention consists of the fact that it allows complete washing of the dialysis liquid feed route during the phase of draining of the Liquid present in the peritoneal cavity, thus eliminating the risk of any particle or microbe contaminations present in the feed route.

In known systems of connection with a Y-connector, during the drainage phase the Liquid present in the peritoneal cavity flows from the patient to the Y-connector, and then to the drain bag. This route (drainage route) is therefore washed by the liquid being drained, which removes possible particles or contaminants present in the route concerned. Nevertheless the section of feed route which stretches from the bag containing the dialysis Liquid to the Y-connector is not washed, and therefore any contaminants cannot be removed. For this reason manufacturers of these devices suggest, once the connection between the patient and the bag containing the dialysis liquid has been made, making 50-100 cc of fresh solution flow along the section which runs from the bag to the Y-connector and to the drain bag, in order to wash this route too.

In the device according to the present invention, the feed circuit is however washed automatically during the drainage phase with approximately 1.5 - 2 Litres of solution, and not with only 50 - 100 cc as in known systems. This type of washing offers a much greater guarantee than that of traditional devices of a feed route which is totally free of contaminants. Figures 3-6 show other embodiments for the bag 1 of Figures 1 and 2.

In Figure 3, the bag 1 is made so as to have an eyelet 12 suitable for holding the tips of the clip 9, to facilitate the operation of separating the bag portion 10 from the remaining of the bag 1. In Figure 4 the bag 1 is provided, at one of its sides, with a tubular appendage 13 with which the two tubes 2 and 3 are engaged. Said tubular appendage 13 also forms the bag portion 10 which is isolated from the remaining of the bag 1 by means of the clip 9. Figure 5 shows a further embodiment of the bag 1. The bag 1 is provided with a weakened line 14, for example punching. At the time of use, the weakened Line 14 is broken so as to obtain, by partial twisting, a tubular appendage 15, wherein the two tubes 3 and 4 are engaged. Said tubular appendage 15 is separated, by means of the clip 9, from the remaining of the bag 1. This embodiment, in addition to ensuring greater safety, allows a saving in material.

The foregoing description shows four embodiments of the present invention. Other embodiments are obviously possible, all of them however coming within the sphere of the present invention.

Claims

C L A I M S

1. Device for continuous ambulatory peritoneal dialysis comprising a bag (1), containing a dialysis liquid, which can be coupled to a catheter (5) permanently attached to a patient ⁽6⁾, characterised in that a first tube (2) and a second tube ⁽3⁾ extend from said bag ⁽1⁾ and can be connected to said catheter (5) and a drain container (8) respectively, said first and second tubes (2,3) being connected to a portion (10) of the bag (1) which can be separated hydraulically from the remaining of the bag (1).

2. Device according to claim 1, characterised in that hydraulic separation of said bag portion (10) may be performed by means of a clip (9).

3. Device according to claim 1, characterised in that said first tube (2) comprises a connector (4) for connection of said first tube (2) to said catheter (5).

4. Device according to claim 1, characterised in that said bag portion is a corner portion of said bag (1).

5. Device according to claim 4, characterised in that said bag (1) is provided, near said bag portion (10), with an eyelet

(12) for holding the tip of a clip (9).

6. Device according to claim 1, characterised in that said bag portion (10) is formed by a tubular appendage (13) of said bag (1).

7. Device according to claim 1, characterised in that said bag (1) comprises a weakened line for the partial separation of said bag portion (10) from said bag (1).

8. Device according to any one of the previous claims, characterised in that said drain container consists of a second bag connected to said second tube (3⁾.