WO1988000476A1 - A device for release of a substance - Google Patents

A device for release of a substance Download PDF

Info

Publication number
WO1988000476A1
WO1988000476A1 PCT/SE1987/000319 SE8700319W WO8800476A1 WO 1988000476 A1 WO1988000476 A1 WO 1988000476A1 SE 8700319 W SE8700319 W SE 8700319W WO 8800476 A1 WO8800476 A1 WO 8800476A1
Authority
WO
WIPO (PCT)
Prior art keywords
outlet
liquid
inlet
valve core
connector
Prior art date
Application number
PCT/SE1987/000319
Other languages
French (fr)
Inventor
Bengt Göran BERGLUND
Nils Billy Nilson
Åke Sigvard NILSSON
Original Assignee
Aktiebolaget Hässle
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 Aktiebolaget Hässle filed Critical Aktiebolaget Hässle
Priority to BR8707742A priority Critical patent/BR8707742A/en
Priority to HU873882A priority patent/HU207803B/en
Priority to UA4613257A priority patent/UA15928A/en
Priority to JP62504210A priority patent/JPH084625B2/en
Priority to KR1019880700258A priority patent/KR950003495B1/en
Publication of WO1988000476A1 publication Critical patent/WO1988000476A1/en
Priority to NO880792A priority patent/NO166837C/en
Priority to DK116688A priority patent/DK165484C/en
Priority to FI890108A priority patent/FI93311C/en
Priority to LV931010A priority patent/LV5579A3/en

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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1407—Infusion of two or more substances
    • A61M5/1409—Infusion of two or more substances in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00—Fluid handling
    • Y10T137/4891—With holder for solid, flaky or pulverized material to be dissolved or entrained

Definitions

  • the present invention is related to a device intended to be used in parenteral liquid administration to a patient, whereby one durin such administration desires to release a substance, such as a drug, to the liquid.
  • EP-B-0059694 A device by which drugs can be supplied to a parenteral liquid flow is shown by EP-B-0059694. Modified such devices are shown by EP-A-0077604, EP 85850141.4, EP-A-0100296 and WO 86/03416.
  • An object of the present invention is to achieve a device where a container for a dry drug preparation exchangeably can be connected to a liquid administration system, whereupon the liquid can be de ⁇ viated and brought into contact with the drug thus that the drug is added to the liquid during administration of the liquid.
  • a fur ⁇ ther object is to achieve a device where inadvertent deviation of the liquid is avoided when no drug container is connected.
  • the device of the invention is a device for release of a sub ⁇ stance from a solid preparation thereof to a flowing liquid during simultaneous parenteral administration of the liquid to a patient, which device comprises a connector connectabie into a system for parenteral administration of the liquid, and having an inlet and outlet with a valve device which comprises a mobile valve core having a bypass position providing for direct liquid flow from the inlet to the outlet of the connector and a working position pro-
  • valve core has an outlet means and a separate inlet means simultaneously connectabie to an inlet means and a separate outlet means respectively on the releasable container, the releasable container further having therein means for conducting the liquid from the inlet thereof to a space where it will contact the solid preparation, and further to the outlet of the releasable container, and via the valve core in a flow path to the outlet of the connector.
  • the releasable container is a manoeuvre device for the valve core and the valve core has no other manoeuvre devices.
  • the releasable container may function as a handle gripping the end of the valve core by means of its inlet and outlet means. Inadvertent deviation of the liquid when no con ⁇ tainer is connected will be avoided by the invention in particular by this embodiment. Thus, risks of liquid spillage and air suction into the administration system are reduced.
  • the outlet and inlet of the valve core are connectabie to the inlet and outlet of the releasable container by socket means, and preferably the socket means are tapered sockets fitting in tapered holes, and preferably the tapered sockets are the outlet means and inlet means of the releasable container and that the tapered holes are the inlet means and outlet means on the valve core.
  • a filter is arranged within the connector in the flow path from the valve in the working position to the outlet of the connector.
  • the flow of liquid in the bypass position of the valve has dual flow paths to the outlet either through the filter or via the valve core.
  • Fig. 1 shows a device according to the invention in a bypass posi ⁇ tion
  • Fig. 2 shows the device in fig. 1 in a working position
  • Fig. 3 shows a connector in a bypass position
  • Fig. 4 shows a connector in a bypass position in section along the line IV-IV in fig. 3,
  • Fig. 5 shows a section through a connector in a working position, with a container for a drug
  • Fig. 6 shows an alternative rear portion of the connector in figs. 1-5.
  • a connector having an inlet via a transfer cannula 2 in one end thereof, that will usually be the upper end in use, and an outlet via a piercable membrane 3 in the opposite en ⁇ there ⁇ of.
  • a valve device consisting of a cylind ⁇ rical valve housing 4 and a cylindrical valve core 5 turnable there ⁇ in.
  • an inlet channel 6 runs, which in the bypass position of the valve shown in fig. 4 opens into a first bypass channel 7 through the valve core, said bypass channel opening into a first inner space 8 in the connector.
  • the liquid may, when the valve is in the bypass position, follow either of dual flow paths via a second bypass channel 9 through the valve core or via a bacteria filter 10, sealingly attached along its periphery to walls defining a second inner space 11 in the connector, to said second inner space which can be put in liquid connection with the outlet 12 of the connector via the membrane 3.
  • a second bypass channel 9 through the valve core or via a bacteria filter 10
  • sealingly attached along its periphery to walls defining a second inner space 11 in the connector to said second inner space which can be put in liquid connection with the outlet 12 of the connector via the membrane 3.
  • the inlet channel 6 opens into a channel 13 through the valve core, which channel via an outlet means of the valve core being a tapered opening 13A is in communication therein with tapered inlet socket 14 on a releas ⁇ able drug container 15 being shaped substantially like an elongated box having its inlet socket 14 and a separate tapered outlet socket 18 adjacent to each other extending from one of the elongated faces thereof adjacent to one end thereof.
  • the liquid may circulate to the outlet socket 18 of the container, which socket via a tapered opening 19A in the valve core, being inlet means thereof, is in communication with a channel 19 through the valve core.
  • Said channel opens into the first inner space 8, while the channel 19 has no opening direct ⁇ ly into the second inner space 11, whereby the liquid at the working position of the valve can only pass via filter 10 to space 11.
  • the cylindrical surface of the valve core 5 seals against the cylindri ⁇ cal surface of the valve housing 4.
  • the valve core is secured against axial movement by a flange 5A thereon resting against an edge 4A in the valve housing and by an axial extension 5B to the valve core resting against a rear wall 21 of the connector 1.
  • An airing channel 20 is in a manner known per se arranged through the transfer cannula 2.
  • the first inner space 8 is l mited by the rear portion 21 of the chamber and by side and end walls of the connector 1 and by the filter 10.
  • a second transfer cannula for connection of a drip chamber via the membrane 3 to the connector is hinted with 22.
  • a drip chamber function may be built into the connector 1 or located at a different position in the system.
  • An alternative rear portion 23 has a hydrophobic filter 24 through which air from the downstream parts of the administration system can be let out.
  • While the device of the invention has a bypass position of the valve thereof and a working position in which the substance is released and administered it does not have a position in which the substance is merely reconstituted or dissolved while remaining in the releas ⁇ able container.
  • the parenteral administration system may further comprise known details such as a liquid container (bottle or bag), conduits, injec ⁇ tion ports, branchings, clasps, pumps, a cannula etc.
  • the device may be made as molded plastic parts, preferably in dis- posable design.

Abstract

Device for release of a substance from a solid preparation thereof to a flowing liquid during simultaneous parenteral administration of the liquid to a patient, which device comprises a connector (1) connectable into a system for parenteral administration of the liquid, and having an inlet (6) and an outlet (12) for the liquid and means for liquid communication of said inlet and outlet with a valve device (4, 5) which comprises a mobile valve core (5) having a bypass position providing for direct liquid flow from the inlet to the outlet of the connector and a working position providing for liquid flow from the inlet (6) of the connector into a releasable container (15) for the solid preparation. The device is characterized in that the valve core (5) has an outlet means (13A) and a separate inlet means (19A) simultaneously connectable to an inlet means (14) and a separate outlet means (18) respectively on the releasable container, the releasable container further having therein means (16) for conducting the liquid from the inlet thereof to a space where it will contact the solid preparation (17), and further to the outlet of the releasable container (18), and via the valve core in a flow path to the outlet (12) of the connector.

Description

A device for release of a substance
The present invention is related to a device intended to be used in parenteral liquid administration to a patient, whereby one durin such administration desires to release a substance, such as a drug, to the liquid.
A device by which drugs can be supplied to a parenteral liquid flow is shown by EP-B-0059694. Modified such devices are shown by EP-A-0077604, EP 85850141.4, EP-A-0100296 and WO 86/03416. A device for connection into a flow of infusion liquid, where the liquid by means of a valve can be led either via a vial for a drug to the patient or bypassing said vial, is shown by EP-A-0163387. A similar device having three operative valve positions, one for bypass of the liquid, one for dilution of a drug and one for emptying of a drug solution in an administration system, is shown by US 4534758. The two lastmentioned systems require that a liquid preparation ready for administration is formed in the vial before the valve is put in an administration position.
An object of the present invention is to achieve a device where a container for a dry drug preparation exchangeably can be connected to a liquid administration system, whereupon the liquid can be de¬ viated and brought into contact with the drug thus that the drug is added to the liquid during administration of the liquid. A fur¬ ther object is to achieve a device where inadvertent deviation of the liquid is avoided when no drug container is connected.
Thus the device of the invention is a device for release of a sub¬ stance from a solid preparation thereof to a flowing liquid during simultaneous parenteral administration of the liquid to a patient, which device comprises a connector connectabie into a system for parenteral administration of the liquid, and having an inlet and outlet with a valve device which comprises a mobile valve core having a bypass position providing for direct liquid flow from the inlet to the outlet of the connector and a working position pro-
SUBSTITUTESHEET viding for liquid flow from the inlet of the connector into a releas¬ able container for the solid preparation. The device of an invention is characterized in that the valve core has an outlet means and a separate inlet means simultaneously connectabie to an inlet means and a separate outlet means respectively on the releasable container, the releasable container further having therein means for conducting the liquid from the inlet thereof to a space where it will contact the solid preparation, and further to the outlet of the releasable container, and via the valve core in a flow path to the outlet of the connector.
In a preferred embodiment of the invention the releasable container is a manoeuvre device for the valve core and the valve core has no other manoeuvre devices. Thus, when the valve core is rotatable in the valve device the releasable container may function as a handle gripping the end of the valve core by means of its inlet and outlet means. Inadvertent deviation of the liquid when no con¬ tainer is connected will be avoided by the invention in particular by this embodiment. Thus, risks of liquid spillage and air suction into the administration system are reduced.
Preferably the outlet and inlet of the valve core are connectabie to the inlet and outlet of the releasable container by socket means, and preferably the socket means are tapered sockets fitting in tapered holes, and preferably the tapered sockets are the outlet means and inlet means of the releasable container and that the tapered holes are the inlet means and outlet means on the valve core.
In a spec ally preferred embodiment of the device a filter is arranged within the connector in the flow path from the valve in the working position to the outlet of the connector. Suitably the flow of liquid in the bypass position of the valve has dual flow paths to the outlet either through the filter or via the valve core.
Use of a device as described for release of a substance from a solid preparation thereof to a liquid during simultaneous parenteral ad- ministration of the liquid to a patient is a further embodiment of the invention.
The invention is further described with the reference to the enclosed drawings where
Fig. 1 shows a device according to the invention in a bypass posi¬ tion,
Fig. 2 shows the device in fig. 1 in a working position,
Fig. 3 shows a connector in a bypass position,
Fig. 4 shows a connector in a bypass position in section along the line IV-IV in fig. 3,
Fig. 5 shows a section through a connector in a working position, with a container for a drug,
Fig. 6 shows an alternative rear portion of the connector in figs. 1-5.
With 1 is denoted a connector having an inlet via a transfer cannula 2 in one end thereof, that will usually be the upper end in use, and an outlet via a piercable membrane 3 in the opposite enα there¬ of. In the connector there is a valve device consisting of a cylind¬ rical valve housing 4 and a cylindrical valve core 5 turnable there¬ in. Through the transfer cannula 2 an inlet channel 6 runs, which in the bypass position of the valve shown in fig. 4 opens into a first bypass channel 7 through the valve core, said bypass channel opening into a first inner space 8 in the connector. From the first inner space the liquid may, when the valve is in the bypass position, follow either of dual flow paths via a second bypass channel 9 through the valve core or via a bacteria filter 10, sealingly attached along its periphery to walls defining a second inner space 11 in the connector, to said second inner space which can be put in liquid connection with the outlet 12 of the connector via the membrane 3. In the working position of the valve as shown in fig. 5, which posi¬ tion is at a 90° angle with the bypass position, the inlet channel 6 opens into a channel 13 through the valve core, which channel via an outlet means of the valve core being a tapered opening 13A is in communication therein with tapered inlet socket 14 on a releas¬ able drug container 15 being shaped substantially like an elongated box having its inlet socket 14 and a separate tapered outlet socket 18 adjacent to each other extending from one of the elongated faces thereof adjacent to one end thereof. Via an inlet channel T6 and a bed of granules 17 of the pharmaceutical preparation of the drug being released to the liquid, the liquid may circulate to the outlet socket 18 of the container, which socket via a tapered opening 19A in the valve core, being inlet means thereof, is in communication with a channel 19 through the valve core. Said channel opens into the first inner space 8, while the channel 19 has no opening direct¬ ly into the second inner space 11, whereby the liquid at the working position of the valve can only pass via filter 10 to space 11. The cylindrical surface of the valve core 5 seals against the cylindri¬ cal surface of the valve housing 4. The valve core is secured against axial movement by a flange 5A thereon resting against an edge 4A in the valve housing and by an axial extension 5B to the valve core resting against a rear wall 21 of the connector 1. An airing channel 20 is in a manner known per se arranged through the transfer cannula 2. The first inner space 8 is l mited by the rear portion 21 of the chamber and by side and end walls of the connector 1 and by the filter 10. A second transfer cannula for connection of a drip chamber via the membrane 3 to the connector is hinted with 22. Alternatively a drip chamber function may be built into the connector 1 or located at a different position in the system.
An alternative rear portion 23 has a hydrophobic filter 24 through which air from the downstream parts of the administration system can be let out.
While the device of the invention has a bypass position of the valve thereof and a working position in which the substance is released and administered it does not have a position in which the substance is merely reconstituted or dissolved while remaining in the releas¬ able container.
The parenteral administration system may further comprise known details such as a liquid container (bottle or bag), conduits, injec¬ tion ports, branchings, clasps, pumps, a cannula etc.
The device may be made as molded plastic parts, preferably in dis- posable design.

Claims

Claims
1. A device for release of a substance from a solid preparation thereof to a flowing liquid during simultaneous parenteral administ- ration of the liquid to a patient, which device comprises a connec¬ tor (1) connectabie into a system for parenteral administration., of the liquid, and having an inlet (6) and an outlet (12) for the liquid and means for liquid communication of said inlet and outlet with a valve device (4, 5) which comprises a mobile valve core (5) having a bypass position providing for direct liquid flow from the inlet to the outlet of the connector and a working position pro¬ viding for liquid flow from the inlet (6) of the connector into a releasable container (15) for the solid preparation, characterized in that the valve core (5) has an outlet means (13A) and a separate inlet means (19A) simultaneously connectabie to an inlet means (14) and a separate outlet means (18) respectively on the releasable container, the releasable container further having therein means (16) for conducting the liquid from the inlet thereof to a space where it will contact the sol d preparation (17), and further to the outlet of the releasable container (18), and via the valve core in a flow path to the outlet (12) of the connector.
2. A device according to claim 1 characterized in that the releas¬ able container (15) is a manoeuvre device for the valve core (5) and that the valve core has no other manoeuvre devices.
3. A device according to claim 1 or 2 characterized in that the outlet and inlet of the valve core are connectabie to the inlet and outlet of the releasable container by socket means (14, 18).
4. A device according to claim 3 characterized in that the socket means are tapered sockets (14, 18) fitting in tapered holes (13A, 19A).
5. A device according to claim 4 characterized in that the tapered sockets (14, 18) are the outlet means and inlet means of the releas¬ able container and that the tapered holes (13A, 19A) are the inlet means and outlet means on the valve core.
6. A device according to one or more of the preceding claims charac¬ terized in that a filter (10) is arranged within the connector in the flow path from the valve (4, 5), when in the working position, to the outlet (12) of the connector.
7. A device according to claim 6 characterized in that the flow of liquid in the bypass position of the valve has dual flow paths to the outlet either through the filter (10) or via the valve core (5).
8. Use of a device as claimed in any of claims 1 to 7 for release of a substance from a solid preparation thereof to a liquid during simultaneous parenteral administration of the liquid to a patient.
PCT/SE1987/000319 1986-07-10 1987-07-06 A device for release of a substance WO1988000476A1 (en)

Priority Applications (9)

Application Number Priority Date Filing Date Title
BR8707742A BR8707742A (en) 1986-07-10 1987-07-06 DEVICE TO RELEASE A SUBSTANCE
HU873882A HU207803B (en) 1986-07-10 1987-07-06 Device for solving material
UA4613257A UA15928A (en) 1986-07-10 1987-07-06 CONNECTOR OF THE DEVICE FOR PARARTERIAL INTRODUCTION OF LIQUID INTO THE ORGANISM OF THE BIOBJECT
JP62504210A JPH084625B2 (en) 1986-07-10 1987-07-06 Device for releasing substances
KR1019880700258A KR950003495B1 (en) 1986-07-10 1987-07-06 Device for release of substance
NO880792A NO166837C (en) 1986-07-10 1988-02-23 DEVICE FOR RELEASE OF A SUBSTANCE.
DK116688A DK165484C (en) 1986-07-10 1988-03-04 DEVICE FOR RELEASE OF A SUBSTANCE FROM A SOLID PREPARATION AND USE OF THE DEVICE
FI890108A FI93311C (en) 1986-07-10 1989-01-09 Device for release of a substance
LV931010A LV5579A3 (en) 1986-07-10 1993-07-30 Liquid Parenteral Injection Device Connected Biological Objects In The Body

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE8603072A SE461765B (en) 1986-07-10 1986-07-10 DEVICE FOR RELEASE OF SUBSTANCE
SE8603072-3 1986-07-10

Publications (1)

Publication Number Publication Date
WO1988000476A1 true WO1988000476A1 (en) 1988-01-28

Family

ID=20365087

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SE1987/000319 WO1988000476A1 (en) 1986-07-10 1987-07-06 A device for release of a substance

Country Status (22)

Country Link
US (1) US5201705A (en)
EP (1) EP0252892B1 (en)
JP (1) JPH084625B2 (en)
KR (1) KR950003495B1 (en)
AT (1) ATE88360T1 (en)
AU (1) AU611857B2 (en)
BR (1) BR8707742A (en)
CA (1) CA1295198C (en)
DE (1) DE3785501T2 (en)
DK (1) DK165484C (en)
ES (1) ES2039479T3 (en)
FI (1) FI93311C (en)
HU (1) HU207803B (en)
IE (1) IE61786B1 (en)
LT (1) LT3700B (en)
LV (1) LV5579A3 (en)
NO (1) NO166837C (en)
NZ (1) NZ220952A (en)
RU (1) RU1799273C (en)
SE (1) SE461765B (en)
UA (1) UA15928A (en)
WO (1) WO1988000476A1 (en)

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NO880792L (en) 1988-02-23
US5201705A (en) 1993-04-13
ATE88360T1 (en) 1993-05-15
SE8603072L (en) 1988-01-11
HU207803B (en) 1993-06-28
DK165484B (en) 1992-12-07
AU7693187A (en) 1988-02-10
IE871818L (en) 1988-01-10
LT3700B (en) 1996-02-26
BR8707742A (en) 1989-08-15
LTIP1684A (en) 1995-07-25
NO166837B (en) 1991-06-03
CA1295198C (en) 1992-02-04
SE461765B (en) 1990-03-26
HUT48469A (en) 1989-06-28
KR880701570A (en) 1988-11-03
DE3785501T2 (en) 1993-07-29
DK165484C (en) 1993-04-19
IE61786B1 (en) 1994-11-30
KR950003495B1 (en) 1995-04-13
SE8603072D0 (en) 1986-07-10
FI890108A0 (en) 1989-01-09
UA15928A (en) 1997-06-30
FI93311C (en) 1995-03-27
FI890108A (en) 1989-01-09
AU611857B2 (en) 1991-06-27
EP0252892B1 (en) 1993-04-21
ES2039479T3 (en) 1993-10-01
LV5579A3 (en) 1994-05-10
JPH01503121A (en) 1989-10-26
RU1799273C (en) 1993-02-28
NZ220952A (en) 1990-01-29
EP0252892A1 (en) 1988-01-13
DK116688D0 (en) 1988-03-04
JPH084625B2 (en) 1996-01-24
DK116688A (en) 1988-03-04
NO166837C (en) 1991-09-11
DE3785501D1 (en) 1993-05-27
NO880792D0 (en) 1988-02-23

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