WO2000029051A1 - Disposable syringe for the automatic mixing of a first and a second component - Google Patents

Disposable syringe for the automatic mixing of a first and a second component Download PDF

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Publication number
WO2000029051A1
WO2000029051A1 PCT/IT1999/000362 IT9900362W WO0029051A1 WO 2000029051 A1 WO2000029051 A1 WO 2000029051A1 IT 9900362 W IT9900362 W IT 9900362W WO 0029051 A1 WO0029051 A1 WO 0029051A1
Authority
WO
WIPO (PCT)
Prior art keywords
syringe
fact
piston
chamber
component
Prior art date
Application number
PCT/IT1999/000362
Other languages
French (fr)
Inventor
Giancarlo Riminucci
Original Assignee
B.F. Elettromeccanica S.R.L.
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 B.F. Elettromeccanica S.R.L. filed Critical B.F. Elettromeccanica S.R.L.
Priority to AU12950/00A priority Critical patent/AU1295000A/en
Publication of WO2000029051A1 publication Critical patent/WO2000029051A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31596Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31596Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing
    • A61M2005/31598Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing having multiple telescopically sliding coaxial pistons encompassing volumes for components to be mixed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5013Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe
    • A61M5/502Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe for blocking the piston

Definitions

  • Disposable syringe for the automatic mixing of a first and a second component.
  • the present invention refers to the technical sector of medical instruments, and in particular to a disposable syringe for the automatic mixing of a first and a second component, such as an active principle and a diluent, whose mixture is designed to be injected.
  • Syringes of known type, and in particular those used in the medical field are basically made up of a cylinder inside which a piston slides, with the possibility of assembling a metal needle at one end of the cylinder. According to the usual procedure, once the sterilized needle has been inserted in the appropriate housing at the end of the syringe cylinder, the user cuts the neck of the phial containing a diluent liquid with a small file, in order to insert the needle and aspirate the said liquid inside the cylinder.
  • the user inserts the liquid in a bottle containing the powdered active principle, after perforating the rubber cap of the bottle with the needle. Once the two components have been mixed, the mixture is aspirated inside the syringe in order to complete the syringe preparation for the injection.
  • Another disadvantage is represented by the presence of at least four disposable elements for each injection (the syringe, the phial with the diluent liquid, the small file, and the bottle containing the active principle).
  • the use of several "disposable" elements increases the risk of contamination for the needle and the mixture to be injected before the injection.
  • the operating modes for the preparation of a simple injection become very complicated and must be always carried out by specialized personnel.
  • the main purpose of the invention is to provide a disposable syringe that enables the user to automatically mix the active principle with the diluent liquid, thus considerably reducing the risk of contamination for the needle before the injection.
  • Another purpose of the invention is to provide an easy-to-use and safe syringe, with simple construction principle and reduced cost.
  • Figure 1 is a longitudinal view of the syringe according to the present invention in the load condition ;
  • Figure 2 shows the syringe of fig. 1 in the mixing condition ;
  • Figure 3 shows the syringe of fig. 1 in the discharge condition.
  • number (1) indicates the disposable syringe for the automatic mixing of a first component (2), such as a powdered active principle, and a second component (3), such as a liquid diluent, basically comprising a cylinder (4), a plunger (5) and a needle (14).
  • the cylinder (4) is made up of a tubular element, with circular shape in the preferred embodiment, with one open end and one closed end that terminates with an external dispenser (13), designed to support the needle (14), whose opening is sealed by means of a tab (12), for example of plastic laminar material, aluminum, or polythene paper.
  • the plunger (5) is inserted from the open end of the cylinder (4), so that the plunger head, on which a membrane (11) is sealed, defines a first chamber (6), together with the closed end of the cylinder (4), the dispenser (13), the tab (12) and the lateral walls of the cylinder.
  • a pair of wings (4a) facing the outside of the syringe (1) is located at the free end of the cylinder (4), while the inside of the cylinder features a series of internal projections (16) on the perimeter, constituting teeth facing the inside of the cylinder (4) and the dispenser (13).
  • the plunger (5) is made up of an external hollow piston (8), inside which an internal piston (9) slides in a coaxial way.
  • the head (8a) of the external piston (8) is provided on the perimeter with a ring seal (17) capable of ensuring hydraulic seal between the external piston (8) and the cylinder (4).
  • the free end (8b) of the external piston (8) is provided with a pair of projections (19) facing the outside of the piston. Near the free end (8b) the same piston (8) is provided on the perimeter with external projections (15), constituting teeth facing the outside of the piston (8) and the dispenser (13).
  • the free end (8b) of the external piston (8) is provided with a housing (18) whose dimensions allow for containing a border (9b) fixed to the free end of the internal piston (9).
  • a second chamber (10) is defined between the side walls of the external piston (8), the head (9a) of the internal piston (9) and the membrane (11).
  • the membrane (11) and the tab (12) are made of a laminar plastic material, aluminum or polythene paper.
  • the operating modes of the syringe (1) are very simple. The operator starts from the load condition (C) of the syringe, as shown in Fig. 1 , in which the first chamber (6) contains, for example, the diluting liquid (3) and the second chamber (10) contains the active principle (2), mainly a powdered one.
  • the operator exerts some pressure on the border (9b) of the internal piston (9) until the internal piston (9) is completely inserted in the housing (18).
  • the head (9a) of the internal piston (9) exerts some pressure on the active principle (2) so that the active principle (2) forces the membrane (11) and completely exits the second chamber (10), entering the first chamber (6) with the diluent liquid (3) and causing a mixing condition M for the syringe (1), as shown in Fig. 2.
  • the operator shakes the syringe (1), thus favoring the mixing of the active principle (2) with the diluent liquid (3) inside the first chamber (6).
  • the main advantage of the invention is to provide a disposable syringe that enables the user to automatically mix the active principle with the diluent liquid, thus considerably reducing the risk of contamination for the needle before the injection.
  • a further advantage is to provide an easy-to-use and safe syringe, with simple construction principle and reduced cost.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A disposable syringe for the automatic mixing of an active principle (2) and a diluent (3) comprising a cylinder (4), inside which a plunger (5) slides, defining a first chamber (6) that contains the diluent (3), made up of an external piston (8) inside which an internal piston (9) co-axially slides, defining a second chamber (10) that contains the active principle (29) in the presence of a load condition (C) of the syringe (1). The relative movement of the internal piston (9) with respect to the external piston (8) towards the first chamber (6) determines the passage from the load condition (C) to the mixing condition (M) of the syringe (1), thus determining the fracture of a membrane (11) used to seal the head of the plunger (5) and the complete pouring of the active principle (2) into the diluent (3). The additional movement of the internal (9) and external (8) pistons, ejects the mixture (7) of diluent and active principle.

Description

Description
Disposable syringe for the automatic mixing of a first and a second component.
The present invention refers to the technical sector of medical instruments, and in particular to a disposable syringe for the automatic mixing of a first and a second component, such as an active principle and a diluent, whose mixture is designed to be injected. Syringes of known type, and in particular those used in the medical field, are basically made up of a cylinder inside which a piston slides, with the possibility of assembling a metal needle at one end of the cylinder. According to the usual procedure, once the sterilized needle has been inserted in the appropriate housing at the end of the syringe cylinder, the user cuts the neck of the phial containing a diluent liquid with a small file, in order to insert the needle and aspirate the said liquid inside the cylinder. Then, the user inserts the liquid in a bottle containing the powdered active principle, after perforating the rubber cap of the bottle with the needle. Once the two components have been mixed, the mixture is aspirated inside the syringe in order to complete the syringe preparation for the injection.
This procedure is extremely disadvantageous, since the needle must perforate the relatively hard rubber cap of the bottle before being used for the injection. The point of the needle gets often damaged during this operation and therefore the needle looses its typical characteristic of being as "painless" as possible during the injection to the patient.
Another disadvantage is represented by the presence of at least four disposable elements for each injection (the syringe, the phial with the diluent liquid, the small file, and the bottle containing the active principle). As a matter of fact, the use of several "disposable" elements increases the risk of contamination for the needle and the mixture to be injected before the injection. At the same time, the operating modes for the preparation of a simple injection become very complicated and must be always carried out by specialized personnel.
The main purpose of the invention, therefore, is to provide a disposable syringe that enables the user to automatically mix the active principle with the diluent liquid, thus considerably reducing the risk of contamination for the needle before the injection.
Another purpose of the invention is to provide an easy-to-use and safe syringe, with simple construction principle and reduced cost. The above purposes are obtained according to the contents of the claims. The characteristics of the invention are explained below with particular reference to the enclosed drawings, whereby:
• Figure 1 is a longitudinal view of the syringe according to the present invention in the load condition ;
• Figure 2 shows the syringe of fig. 1 in the mixing condition ;
• Figure 3 shows the syringe of fig. 1 in the discharge condition. With reference to Figures from 1 to 3, number (1) indicates the disposable syringe for the automatic mixing of a first component (2), such as a powdered active principle, and a second component (3), such as a liquid diluent, basically comprising a cylinder (4), a plunger (5) and a needle (14). The cylinder (4) is made up of a tubular element, with circular shape in the preferred embodiment, with one open end and one closed end that terminates with an external dispenser (13), designed to support the needle (14), whose opening is sealed by means of a tab (12), for example of plastic laminar material, aluminum, or polythene paper. The plunger (5) is inserted from the open end of the cylinder (4), so that the plunger head, on which a membrane (11) is sealed, defines a first chamber (6), together with the closed end of the cylinder (4), the dispenser (13), the tab (12) and the lateral walls of the cylinder.
A pair of wings (4a) facing the outside of the syringe (1) is located at the free end of the cylinder (4), while the inside of the cylinder features a series of internal projections (16) on the perimeter, constituting teeth facing the inside of the cylinder (4) and the dispenser (13). The plunger (5) is made up of an external hollow piston (8), inside which an internal piston (9) slides in a coaxial way.
The head (8a) of the external piston (8) is provided on the perimeter with a ring seal (17) capable of ensuring hydraulic seal between the external piston (8) and the cylinder (4). The free end (8b) of the external piston (8) is provided with a pair of projections (19) facing the outside of the piston. Near the free end (8b) the same piston (8) is provided on the perimeter with external projections (15), constituting teeth facing the outside of the piston (8) and the dispenser (13). Moreover, the free end (8b) of the external piston (8) is provided with a housing (18) whose dimensions allow for containing a border (9b) fixed to the free end of the internal piston (9).
When the internal piston (9) is partially inserted in the external piston (8), a second chamber (10) is defined between the side walls of the external piston (8), the head (9a) of the internal piston (9) and the membrane (11). It must be advantageously noted that the membrane (11) and the tab (12) are made of a laminar plastic material, aluminum or polythene paper. The operating modes of the syringe (1) are very simple. The operator starts from the load condition (C) of the syringe, as shown in Fig. 1 , in which the first chamber (6) contains, for example, the diluting liquid (3) and the second chamber (10) contains the active principle (2), mainly a powdered one.
Then, holding the syringe (1) from the external piston (8) and levering on the projections (19), the operator exerts some pressure on the border (9b) of the internal piston (9) until the internal piston (9) is completely inserted in the housing (18). At this stage, the head (9a) of the internal piston (9) exerts some pressure on the active principle (2) so that the active principle (2) forces the membrane (11) and completely exits the second chamber (10), entering the first chamber (6) with the diluent liquid (3) and causing a mixing condition M for the syringe (1), as shown in Fig. 2. Now, the operator shakes the syringe (1), thus favoring the mixing of the active principle (2) with the diluent liquid (3) inside the first chamber (6). Then, he couples the support (14a) of the needle (14) with the dispenser (13), allowing for the perforation of the tab (12) by the end of the needle inside the support (14a).
The operator holds the syringe (1) from the cylinder (4) and by levering on the wings (16) exerts some pressure on the coplanar heads (8b and 9b) of the external (8) and internal (9) pistons, respectively, so that the mixture (7) of diluent (3) and active principle (2) is ejected out of the chamber (6) through the dispenser (13) and the needle (14), allowing for the injection and for the discharge condition (S) of the syringe (1), as shown in Fig. 3.
The main advantage of the invention is to provide a disposable syringe that enables the user to automatically mix the active principle with the diluent liquid, thus considerably reducing the risk of contamination for the needle before the injection.
A further advantage is to provide an easy-to-use and safe syringe, with simple construction principle and reduced cost.

Claims

Claims
1. A disposable syringe for the automatic mixing of a first (2) and a second (3) component, comprising a cylinder (4) with dispenser (13), inside which a plunger (5) slides between the mixing condition (M) of the syringe (1), in which the mixture (7) to be injected, made up of the first and second component, is contained inside a first chamber (6), including the dispenser (13) and defined by the cylinder (4) and the head of the plunger (5), and the discharge condition (S) of the syringe (1), in which the mixture (7) is ejected from the chamber (6), it being characterized by the fact that the plunger (5) is made up of an external piston (8) inside which an internal piston (9) slides in a coaxial way, which, during the load condition
(C), defines a second chamber (10) between the head (9a) of the internal piston (9), the side walls of the external piston (8) and membrane (11) used to seal the head (8a) of the external piston (8), with the internal piston (9) that longitudinally translates towards the head (8a) during the passage from the load condition (C) to the mixing condition (M), thus determining the fracture of the membrane ( 1) and the complete pouring of the active principle (2) into the diluent (3); the first chamber (6) featuring a dispenser (13) sealed with a tab (12) that can be perforated by an hollow needle (14) through which the mixture (7) is ejected from the first chamber (6) during the passage from the mixing condition (M) to the discharge condition (S) due to the simultaneous longitudinal movement of both the external (8) and internal (9) pistons towards the dispenser (13).
2. Syringe according to claim 1 , characterized by the fact that on its free end (8b) the external piston (8) features a series of internal projections (15) on the perimeter, capable of complementarily engaging with a series of internal projections (16) of the cylinder (4) during the discharge condition (S) in order to prevent the reuse of the syringe (1).
3. Syringe according to claim 1 , characterized by the fact that the head (8a) of the external piston (8) is provided on the perimeter with a seal (17) at least, capable of ensuring hydraulic seal between the external piston (8) and the cylinder (4).
4. Syringe according to claim 1 , characterized by the fact that the free end (8b) of the external piston (8) is provided with a housing (18) suitable for containing a border (9b) fixed to the free end of the internal piston (9) during the mixing (M) and discharge (S) conditions.
5. Syringe according to claim 1 , characterized by the fact that the membrane (11) and the tab (12) are made of a laminar plastic material, aluminum or polythene paper, by the fact
6. Syringe according to claim 1 , characterized by the fact that the membrane (11) is pre-fractured so that it does not detach from the head (8a) of the external piston (8) during the mixing (M) and discharge (S) conditions.
7. Syringe according to claim 1 , characterized by the fact that a pair of wings (4a) facing the outside of the syringe (1) is located at the free end of the cylinder (4).
8. Syringe according to claim 1 , characterized by the fact that the free end (8b) of the external piston (8) features at least a projection (19) facing the outside of the external piston (8).
9. Syringe according to claim 1 , characterized bv the fact that the first component (2) is represented by a powdered active principle and the second component (3) is represented by a liquid diluent.
10. Syringe according to claim 1 , characterized by the fact that the first component (2) is represented by a liquid diluent and the second component (3) is represented by a powdered active principle.
PCT/IT1999/000362 1998-11-13 1999-11-10 Disposable syringe for the automatic mixing of a first and a second component WO2000029051A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU12950/00A AU1295000A (en) 1998-11-13 1999-11-10 Disposable syringe for the automatic mixing of a first and second component

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITBO98A000633 1998-11-13
IT1998BO000633A IT1304416B1 (en) 1998-11-13 1998-11-13 DISPOSABLE SYRINGE FOR THE AUTOMATIC MIXING OF A FIRST AND A SECOND COMPONENT.

Publications (1)

Publication Number Publication Date
WO2000029051A1 true WO2000029051A1 (en) 2000-05-25

Family

ID=11343503

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IT1999/000362 WO2000029051A1 (en) 1998-11-13 1999-11-10 Disposable syringe for the automatic mixing of a first and a second component

Country Status (3)

Country Link
AU (1) AU1295000A (en)
IT (1) IT1304416B1 (en)
WO (1) WO2000029051A1 (en)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002076542A1 (en) * 2001-02-28 2002-10-03 Mikael Hetting A disposable syringe
JP2014028041A (en) * 2012-07-31 2014-02-13 Yoshino Kogyosho Co Ltd Mixing and spouting device
WO2014093926A1 (en) * 2012-12-14 2014-06-19 Larson Bryan Dual medicament carpule for dental syringes
WO2014179143A1 (en) * 2013-04-29 2014-11-06 3M Innovative Properties Company A syringe for dispensing a medicament
USD755957S1 (en) 2013-12-13 2016-05-10 Bryan Larson Dental carpule

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4693706A (en) * 1986-08-11 1987-09-15 Mark L. Anderson Two compartment mixing syringe
GB2229374A (en) * 1989-02-17 1990-09-26 Bespak Plc Two-compartment mixing and dispensing apparatus
WO1992018187A1 (en) * 1991-04-11 1992-10-29 Safe-T-Limited Syringe with retractable needle
US5489267A (en) * 1994-01-03 1996-02-06 Moreno; Saul Double chamber disposable syringe
EP0740942A1 (en) * 1995-05-04 1996-11-06 Sanofi Process of manufacturing a prefilled injection device and injection device produced thereby

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4693706A (en) * 1986-08-11 1987-09-15 Mark L. Anderson Two compartment mixing syringe
GB2229374A (en) * 1989-02-17 1990-09-26 Bespak Plc Two-compartment mixing and dispensing apparatus
WO1992018187A1 (en) * 1991-04-11 1992-10-29 Safe-T-Limited Syringe with retractable needle
US5489267A (en) * 1994-01-03 1996-02-06 Moreno; Saul Double chamber disposable syringe
EP0740942A1 (en) * 1995-05-04 1996-11-06 Sanofi Process of manufacturing a prefilled injection device and injection device produced thereby

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002076542A1 (en) * 2001-02-28 2002-10-03 Mikael Hetting A disposable syringe
JP2014028041A (en) * 2012-07-31 2014-02-13 Yoshino Kogyosho Co Ltd Mixing and spouting device
WO2014093926A1 (en) * 2012-12-14 2014-06-19 Larson Bryan Dual medicament carpule for dental syringes
US9055992B2 (en) 2012-12-14 2015-06-16 Bryan Larson Dual medicament carpule for dental syringes
WO2014179143A1 (en) * 2013-04-29 2014-11-06 3M Innovative Properties Company A syringe for dispensing a medicament
USD755957S1 (en) 2013-12-13 2016-05-10 Bryan Larson Dental carpule

Also Published As

Publication number Publication date
ITBO980633A0 (en) 1998-11-13
ITBO980633A1 (en) 2000-05-13
AU1295000A (en) 2000-06-05
IT1304416B1 (en) 2001-03-19

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