WO2018098806A1 - Connecteur en y et ensemble pour dialyse péritonéale ambulatoire continue - Google Patents

Connecteur en y et ensemble pour dialyse péritonéale ambulatoire continue Download PDF

Info

Publication number
WO2018098806A1
WO2018098806A1 PCT/CN2016/108376 CN2016108376W WO2018098806A1 WO 2018098806 A1 WO2018098806 A1 WO 2018098806A1 CN 2016108376 W CN2016108376 W CN 2016108376W WO 2018098806 A1 WO2018098806 A1 WO 2018098806A1
Authority
WO
WIPO (PCT)
Prior art keywords
connector
drainage
patient
bag
luer interface
Prior art date
Application number
PCT/CN2016/108376
Other languages
English (en)
Inventor
Haijun Cao
Richard Allen Lasher
Mingtao GONG
Zhengxin MA
Original Assignee
Fresenius Medical Care Deutschland Gmbh
Fresenius Medical Care Holdings, Inc.
Fresenius Medical Care R&D (Shanghai) Co., Ltd.
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 Fresenius Medical Care Deutschland Gmbh, Fresenius Medical Care Holdings, Inc., Fresenius Medical Care R&D (Shanghai) Co., Ltd. filed Critical Fresenius Medical Care Deutschland Gmbh
Priority to PCT/CN2016/108376 priority Critical patent/WO2018098806A1/fr
Priority to DE212016000294.5U priority patent/DE212016000294U1/de
Priority to CN201690001822.4U priority patent/CN211536207U/zh
Publication of WO2018098806A1 publication Critical patent/WO2018098806A1/fr

Links

Images

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
    • 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
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1066—Tube connectors; Tube couplings having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath
    • 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
    • A61M2039/1088—Tube connectors; Tube couplings having a plurality of male connectors, e.g. Luer connectors

Definitions

  • the invention relates to a Y-connector for a continuous ambulatory peritoneal dialysis (CAPD) and a set for the CAPD, which set comprises such a Y-connector.
  • CAPD continuous ambulatory peritoneal dialysis
  • a peritoneal dialysis is a procedure for removing toxic substances and metabolites normally removed by the kidneys, and for aiding in regulation of fluid and electrolyte balance.
  • the procedure is accomplished by infusing PD solution through a conduit into the peritoneal cavity. Osmosis and diffusion occur across the peritoneal membrane between plasma of the patient and the solution.
  • PD products are developed with sterilized PD solutions and packaging.
  • a continuous ambulatory peritoneal dialysis is one form of PD that allows the patient to exchange the PD solutions 3-4 times per day.
  • CAPD usually uses a double-bag system (one bag for the solution and a separate empty bag for the patient’s effluent) .
  • the double-bag system provides a new solution bag and a new drainage bag for each treatment or exchange.
  • CAPD can also use a single-bag system, wherein only a solution bag is provided.
  • the patient usually uses a used empty solution bag from a previous treatment or exchange as the drainage bag of a subsequent treatment or exchange.
  • a Y-connector is needed to connect the solution bag and the drainage bag with a patient connector which is to be connected with a catheter or catheter extension, from the patient.
  • a drainage connector is further needed to connect the drainage bag with the Y-connector.
  • the Y-connector, the patient connector and the drainage connector each are manufactured as individual components, which lead to a high cost and additional assembly steps. Moreover, the additional processes, such as a welding or manual assembly are needed to assemble these components, which possibly lead to some potential quality issue, like leakage.
  • an object of the invention is to provide an improved Y-connector for a continuous ambulatory peritoneal dialysis and a set for a continuous ambulatory peritoneal dialysis comprising such a Y-connector.
  • a Y-connector for a continuous ambulatory peritoneal dialysis, wherein the Y-connector as a single molded part comprises an integrated patient port which is configured as a patient connector for connecting with a catheter or a catheter extension.
  • the Y-connector further comprises an integrated drainage port as a drainage connector for connecting with a drainage bag via a drainage transfer tubing.
  • the patient port comprises a patient luer interface; and/or the drainage port comprises a drainage luer interface.
  • the patient luer interface is configured as a first male luer interface; and the patient port comprises a first internal thread disposed concentrically outside of the first male luer interface.
  • the drainage luer interface is configured as a second male luer interface; and the drainage port comprises a second internal thread disposed concentrically outside of the second male luer interface.
  • the drainage port is configured to be capable of being connected with a broken frangible connector which is disposed on a solution transfer tubing connected with a solution bag.
  • the molded part is manufactured by an injection molding process.
  • the Y-connector comprises a collar for preventing touch contamination from a patient.
  • a set for a continuous ambulatory peritoneal dialysis comprising the above Y-connector.
  • the set is for a single-bag CAPD system or a double-bag CAPD system.
  • the number of components can be reduced, the manufacturing process can be simplified and the cost can be reduced.
  • the inventive Y-connector has high reliability and durability.
  • Fig. 1 shows an exemplary double-bag CAPD set comprising a Y-connector according to an exemplary embodiment of the present invention.
  • Fig. 2 shows the Y-connector as a single molded part according to an exemplary embodiment of the present invention in a front view.
  • Fig. 3 shows the Y-connector shown in Fig. 2 in a cross-sectional view.
  • Fig. 4 shows an exemplary single-bag CAPD set comprising a Y-connector according to another exemplary embodiment of the present invention.
  • Fig. 5 shows a state where a used solution bag together with a solution transfer tubing is separated from a used single-bag CAPD set by breaking a frangible connector.
  • Fig. 6 shows the Y-connector as a single molded part according to an exemplary embodiment of the present invention in a front view.
  • Fig. 7 shows the Y-connector shown in Fig. 6 in a cross-sectional view.
  • Fig. 8 shows a connected state of the Y-connector with other parts in a front view.
  • Fig. 1 which set comprises a Y-connector according to an exemplary embodiment of the present invention.
  • the double-bag CAPD set mainly comprises a Y-connector 1, a drainage transfer tubing 2, a solution transfer tubing 3, a drainage bag 4, a solution bag 5 and a frangible plug 6.
  • the Y-connector 1 comprises an integrated patient port 11, a drainage port 12 and a solution port 13.
  • the integrated patient port 11 is configured as a patient connector for connecting with a catheter or catheter extension (not shown) . Before use, the patient port 11 can be covered by a cover 14 to avoid contamination.
  • the drainage port 12 is connected with the drainage bag 4 via the drainage transfer tubing 2.
  • the solution port 13 is connected with the solution bag 5 via the solution transfer tubing 3 and the frangible plug 6.
  • the frangible plug 6 can prevent solution within the solution bag 5 from flowing to the Y-connector 1 in an initial state and can be broken manually in use to allow the solution to flow to the Y-connector 1.
  • Fig. 2 shows the Y-connector 1 as a separate part according to an exemplary embodiment of the present invention in a front view.
  • the Y-connector 1 preferably further comprises a collar 15 for preventing touch contamination from a patient and a handle 16 facilitating handling the Y-connector by the patient.
  • Fig. 3 shows the Y-connector 1 shown in Fig. 2 in a sectional view.
  • the integrated patient port 11 as the patient connector may comprise a patient luer interface, preferably a male luer interface 17, which is to be connected and forming a seal with a corresponding luer interface, preferably a female luer interface of the catheter or catheter extension.
  • the integrated patient port 11 further may comprise an internal thread 18 disposed concentrically outside of the male luer interface 17, as shown in Fig. 3. Also a channel 19 as a flow path can be seen in Fig. 3.
  • Fig. 4 which set comprises a Y-connector according to another exemplary embodiment of the present invention.
  • the single-bag CAPD set mainly comprises a Y-connector 21, a solution transfer tubing 22, a solution bag 23, a frangible plug 24, a frangible connector 25 and a connection tubing 26.
  • the Y-connector 21 comprises an integrated patient port 31, an integrated drainage port 32 and a solution port 33.
  • the integrated patient port 31 is configured as a patient connector for connecting with a catheter or catheter extension (not shown) . Before use, the patient port 31 can be covered by a cover 34 to avoid contamination.
  • the integrated drainage port 32 is configured as a drainage connector for connecting with a drainage bag via a drainage transfer tubing.
  • a single-bag CAPD system using the single-bag CAPD set usually uses a used empty solution bag from a previous exchange or treatment as the drainage bag for a subsequent exchange or treatment. Therefore, the frangible connector 25 is provided between the connection tubing 26 and the solution transfer tubing 22.
  • the solution port 33 is connected with the solution bag 23 via the connection tubing 26, the frangible connector 25, the solution transfer tubing 22 and the frangible plug 24.
  • the frangible plug 24 can prevent solution within the solution bag 23 from flowing to the Y-connector 21 in an initial state and can be broken manually in use to allow the solution to flow to the Y-connector 21.
  • a used solution bag 23’ together with the solution transfer tubing 22 is separated from a used single-bag CAPD set by breaking the frangible connector 25.
  • the broken frangible connector 25’ can be connected with the integrated drainage port 32 such that the used solution bag 23’ can be used as the drainage bag and the solution transfer tubing 22 can be used as the drainage transfer tubing.
  • Fig. 6 shows the Y-connector 21 as a separate part according to an exemplary embodiment of the present invention in a front view.
  • the Y-connector 21 preferably further comprises a collar 27 for preventing touch contamination from a patient and a handle 28 facilitating handling the Y-connector by the patient.
  • Fig. 7 shows the Y-connector 21 shown in Fig. 6 in a sectional view.
  • the integrated patient port 31 as the patient connector may comprise a patient luer interface, preferably a male luer interface 35, which is to be connected and forming a seal with a corresponding luer interface, preferably a female luer interface of the catheter or catheter extension.
  • the integrated patient port 31 further may comprise an internal thread 36 disposed concentrically outside of the male luer interface 35, as shown in Fig. 7. Also a channel 37 as a flow path can be seen in Fig. 7.
  • the integrated drainage port 32 as the drainage connector may comprise a drainage luer interface, preferably a male luer interface 38, which can be connected sealingly with a corresponding luer interface, preferably a female luer interface of the broken frangible connector 25’ .
  • the integrated drainage port 32 further may comprise an internal thread 39 disposed concentrically outside of the male luer interface 38, as shown in Fig. 7.
  • Fig. 8 shows a connected state of the Y-connector 21 with the catheter or catheter extension 41, the connection tubing 26 and the broken frangible connector 25’ disposed on the solution transfer tubing 22 in a front view.
  • the Y-connector 1 and/or the Y-connector 21 may be manufactured as a single molded part by an injection molding process.
  • the basic concept of the present invention is to integrate the patient connector and/or the drainage connector into the conventional Y-connector to form the inventive Y-connector as a single part. In this manner, the number of components can be reduced, the manufacturing process can be simplified and the cost can be reduced. Moreover, the inventive Y-connector has high reliability and durability.

Landscapes

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

Abstract

Un connecteur en Y (1) pour une dialyse péritonéale ambulatoire continue (CAPD) décrit dans la description en tant que pièce moulée unique comprend un orifice de patient (11, 21) intégré, qui est conçu sous la forme d'un connecteur pour patient destiné à être relié à un cathéter ou à une extension de cathéter. L'invention concerne également un ensemble pour une dialyse péritonéale ambulatoire continue qui comprend le connecteur en Y (1) ci-dessus. Conformément au présent connecteur en Y, le nombre d'élément peut être réduit, le processus de fabrication peut être simplifié et les coûts peuvent être réduits. De plus, le présent connecteur en Y présente une fiabilité et une durabilité élevées.
PCT/CN2016/108376 2016-12-02 2016-12-02 Connecteur en y et ensemble pour dialyse péritonéale ambulatoire continue WO2018098806A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
PCT/CN2016/108376 WO2018098806A1 (fr) 2016-12-02 2016-12-02 Connecteur en y et ensemble pour dialyse péritonéale ambulatoire continue
DE212016000294.5U DE212016000294U1 (de) 2016-12-02 2016-12-02 Y-Konnektor und Set für kontinuierliche ambulante Peritonealdialyse
CN201690001822.4U CN211536207U (zh) 2016-12-02 2016-12-02 用于连续非卧床腹膜透析的y型连接器和套件

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2016/108376 WO2018098806A1 (fr) 2016-12-02 2016-12-02 Connecteur en y et ensemble pour dialyse péritonéale ambulatoire continue

Publications (1)

Publication Number Publication Date
WO2018098806A1 true WO2018098806A1 (fr) 2018-06-07

Family

ID=62241095

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2016/108376 WO2018098806A1 (fr) 2016-12-02 2016-12-02 Connecteur en y et ensemble pour dialyse péritonéale ambulatoire continue

Country Status (3)

Country Link
CN (1) CN211536207U (fr)
DE (1) DE212016000294U1 (fr)
WO (1) WO2018098806A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11400015B2 (en) 2016-06-29 2022-08-02 Fresenius Medical Care Deutschland Gmbh Kit comprising at least two bags
CN117815471A (zh) * 2024-03-05 2024-04-05 苏州德中孚医疗器械有限公司 一次性使用非pvc腹膜透析引流袋

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5221267A (en) * 1990-11-30 1993-06-22 Fresenius Usa, Inc. Breakable tubing coupling
US5250041A (en) * 1992-01-16 1993-10-05 Fresenius Usa, Inc. Tubing administration set for use in peritoneal dialysis
US20080214981A1 (en) * 2005-10-27 2008-09-04 Gambro Lundia Ab Extracorporeal Blood Set
US20090143723A1 (en) * 2007-11-29 2009-06-04 Baxter International Inc. Flow control device for peritoneal dialysis
CN201370812Y (zh) * 2008-11-25 2009-12-30 北京双鹤药业股份有限公司 用于腹膜透析输/排液系统的联接接头以及腹膜透析输/排液系统
US20100217179A1 (en) * 2009-02-20 2010-08-26 Baxter International Inc. Bulk delivery peritoneal dialysis system and method

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5221267A (en) * 1990-11-30 1993-06-22 Fresenius Usa, Inc. Breakable tubing coupling
US5250041A (en) * 1992-01-16 1993-10-05 Fresenius Usa, Inc. Tubing administration set for use in peritoneal dialysis
US20080214981A1 (en) * 2005-10-27 2008-09-04 Gambro Lundia Ab Extracorporeal Blood Set
US20090143723A1 (en) * 2007-11-29 2009-06-04 Baxter International Inc. Flow control device for peritoneal dialysis
CN201370812Y (zh) * 2008-11-25 2009-12-30 北京双鹤药业股份有限公司 用于腹膜透析输/排液系统的联接接头以及腹膜透析输/排液系统
US20100217179A1 (en) * 2009-02-20 2010-08-26 Baxter International Inc. Bulk delivery peritoneal dialysis system and method

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11400015B2 (en) 2016-06-29 2022-08-02 Fresenius Medical Care Deutschland Gmbh Kit comprising at least two bags
CN117815471A (zh) * 2024-03-05 2024-04-05 苏州德中孚医疗器械有限公司 一次性使用非pvc腹膜透析引流袋
CN117815471B (zh) * 2024-03-05 2024-06-11 苏州德中孚医疗器械有限公司 一次性使用非pvc腹膜透析引流袋

Also Published As

Publication number Publication date
DE212016000294U1 (de) 2019-06-21
CN211536207U (zh) 2020-09-22

Similar Documents

Publication Publication Date Title
US20240131257A1 (en) Port-flushing control valve
CN106573095B (zh) 用于体外血液透析机的压力输出装置
CN1942216B (zh) 用于体外线路中的流体管线的连接器
EP2883566B1 (fr) Système de traitement sanguin extracorporel et unité de soupape pour pré/post-infusion
US10960135B2 (en) Valve and a method for administering a plurality of drug fluids
EP2068995A2 (fr) Dispositif de distribution de fluide
US20220241480A1 (en) Source container connector
US11931315B2 (en) Locking enteral feeding system
US20130270819A1 (en) Filling fitting
US11504517B2 (en) Fluid line connector devices methods and systems
CN205411784U (zh) 包括内部射流装置的透析机
WO2018098806A1 (fr) Connecteur en y et ensemble pour dialyse péritonéale ambulatoire continue
CN107708789A (zh) 凸式流体连接器、凹式流体连接器以及包括两者的流体连接系统
US11642444B2 (en) Interface device between an external equipment and lines intended to be connected to a patient system
US20220249826A1 (en) Improved three-way connector
US11471659B2 (en) Connector system with a female connector and a male connector, and a system including a plurality of the connector systems
US20230149612A1 (en) Self-Sealing Fluid Connectors
CN109803716A (zh) 医疗流体管线连接器
US20240207496A1 (en) Dual chamber medical fluid container with vented supply line cap and method therefor
US20240207597A1 (en) Vented medical fluid supply line cap, assembly and method therefor
WO2020164038A1 (fr) Adaptateur anti-contamination, raccord, ensemble pour dialyse péritonéale et utilisation de celui-ci dans une dialyse péritonéale
WO2024145177A1 (fr) Récipient de fluide médical à chambre double avec capuchon de voie d'alimentation aéré et procédé associé
TW202102276A (zh) 回輸管系統、套組和方法
WO2024145179A1 (fr) Capuchon ventilé de ligne d'alimentation en fluide médical, ensemble et procédé de stérilisation associé
JP2024516924A (ja) 自動遮断雄型ルアー・フィッティング

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 16923026

Country of ref document: EP

Kind code of ref document: A1

122 Ep: pct application non-entry in european phase

Ref document number: 16923026

Country of ref document: EP

Kind code of ref document: A1