WO1996039207A1 - Dispositif de dialyse peritoneale continue - Google Patents

Dispositif de dialyse peritoneale continue Download PDF

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Publication number
WO1996039207A1
WO1996039207A1 PCT/EP1996/002406 EP9602406W WO9639207A1 WO 1996039207 A1 WO1996039207 A1 WO 1996039207A1 EP 9602406 W EP9602406 W EP 9602406W WO 9639207 A1 WO9639207 A1 WO 9639207A1
Authority
WO
WIPO (PCT)
Prior art keywords
bag
tube
catheter
patient
dialysis
Prior art date
Application number
PCT/EP1996/002406
Other languages
English (en)
Inventor
Diego Furlan
Original Assignee
Haemopharm Industry Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Haemopharm Industry Ag filed Critical Haemopharm Industry Ag
Priority to JP8536833A priority Critical patent/JPH11506370A/ja
Priority to EP96920781A priority patent/EP0831944A1/fr
Publication of WO1996039207A1 publication Critical patent/WO1996039207A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A61M1/1668—Details of containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/08—Tubes; Storage means specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/28—Clamping means for squeezing flexible tubes, e.g. roller clamps

Definitions

  • the present invention relates to a device for continuous peritoneal dialysis.
  • peritoneal dialysis techniques for the treatment of uraemic patients
  • continuous ambulatory peritoneal dialysis 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.
  • a dialysis liquid a solution with added glucose normally isosmotic with plasma
  • 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.
  • the peritoneal cavity is emptied.
  • a connection system known as a "Y-set” 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.
  • Y-connector is filled with disinfectant, typically "Amuchina”.
  • the patient 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").
  • 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
  • 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.
  • 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.
  • the patient 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.
  • the disinfectant may not be provided, or it may only be provided in the point of connection to the catheter.
  • the object of the present invention is that of providing a device for continuous ambulatory peritoneal dialysis, which solves the abovementioned problems.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • FIG. 6 shows the bag of Figure 5 in a second operative condition.
  • 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.
  • 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.
  • the bag 1 is in a container (not shown) which preserves the sterility thereof.
  • a container not shown
  • the bag 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Pulmonology (AREA)
  • External Artificial Organs (AREA)

Abstract

Dispositif de dialyse péritonéale ambulatoire continue constitué d'une poche (1) destinée à contenir un liquide de dialyse pouvant être associée à un cathéter (5) fixé de façon permanente à un patient (6). Un premier tube (2) et un deuxième tube (3) s'étendent depuis la poche et peuvent être raccordés au cathéter (5) ainsi qu'à un récipient de vidange (8) respectivement. Le premier et le deuxième tubes (2, 3) sont reliés à une partie (10) de la poche (1) pouvant être séparée hydrauliquement du reste de la poche (1).
PCT/EP1996/002406 1995-06-06 1996-05-31 Dispositif de dialyse peritoneale continue WO1996039207A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP8536833A JPH11506370A (ja) 1995-06-06 1996-05-31 連続的な外来用腹膜透析用装置
EP96920781A EP0831944A1 (fr) 1995-06-06 1996-05-31 Dispositif de dialyse peritoneale continue

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMI951172A IT1275311B (it) 1995-06-06 1995-06-06 Dispositivo per la dialisi peritoneale continua
ITMI95A001172 1995-06-06

Publications (1)

Publication Number Publication Date
WO1996039207A1 true WO1996039207A1 (fr) 1996-12-12

Family

ID=11371747

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1996/002406 WO1996039207A1 (fr) 1995-06-06 1996-05-31 Dispositif de dialyse peritoneale continue

Country Status (6)

Country Link
EP (1) EP0831944A1 (fr)
JP (1) JPH11506370A (fr)
KR (1) KR19990022210A (fr)
CA (1) CA2223255A1 (fr)
IT (1) IT1275311B (fr)
WO (1) WO1996039207A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998013079A1 (fr) * 1996-09-27 1998-04-02 Baxter International Inc. Systeme, procede et recipient permettant de contenir et de distribuer une solution

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2305991A1 (fr) * 1975-03-31 1976-10-29 Baxter Laboratories Inc Reservoir a double chambre
EP0092528A1 (fr) * 1982-04-16 1983-10-26 SIS-TER S.p.A. Appareillage de dialyse péritonéale
WO1985001270A1 (fr) * 1983-09-16 1985-03-28 Baxter Travenol Laboratories, Inc. Protecteur de port
DE4016144A1 (de) * 1990-05-18 1991-11-21 Fresenius Ag Behaelter zur enteralen ernaehrung

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2305991A1 (fr) * 1975-03-31 1976-10-29 Baxter Laboratories Inc Reservoir a double chambre
EP0092528A1 (fr) * 1982-04-16 1983-10-26 SIS-TER S.p.A. Appareillage de dialyse péritonéale
WO1985001270A1 (fr) * 1983-09-16 1985-03-28 Baxter Travenol Laboratories, Inc. Protecteur de port
DE4016144A1 (de) * 1990-05-18 1991-11-21 Fresenius Ag Behaelter zur enteralen ernaehrung

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998013079A1 (fr) * 1996-09-27 1998-04-02 Baxter International Inc. Systeme, procede et recipient permettant de contenir et de distribuer une solution
US5865793A (en) * 1996-09-27 1999-02-02 Baxter International Inc. System, method and container for holding and delivering a solution
US5876396A (en) * 1996-09-27 1999-03-02 Baxter International Inc. System method and container for holding and delivering a solution

Also Published As

Publication number Publication date
JPH11506370A (ja) 1999-06-08
CA2223255A1 (fr) 1996-12-12
ITMI951172A1 (it) 1996-12-06
ITMI951172A0 (it) 1995-06-06
KR19990022210A (ko) 1999-03-25
EP0831944A1 (fr) 1998-04-01
IT1275311B (it) 1997-08-05

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