CN117677415A - Feeding system for adjusting the feeding volume of a flowable medium and syringe adapter as a component of such a feeding system - Google Patents

Feeding system for adjusting the feeding volume of a flowable medium and syringe adapter as a component of such a feeding system Download PDF

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Publication number
CN117677415A
CN117677415A CN202280031742.3A CN202280031742A CN117677415A CN 117677415 A CN117677415 A CN 117677415A CN 202280031742 A CN202280031742 A CN 202280031742A CN 117677415 A CN117677415 A CN 117677415A
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CN
China
Prior art keywords
syringe
feed
dosing
adapter
silicone
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Pending
Application number
CN202280031742.3A
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Chinese (zh)
Inventor
格罗·艾歇尔克劳特
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Raumedic AG
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Raumedic AG
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Publication date
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Publication of CN117677415A publication Critical patent/CN117677415A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202Separating means
    • A61J1/2027Separating means having frangible parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068Venting means
    • A61J1/2075Venting means for external venting
    • 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
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31535Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31536Blocking means to immobilize a selected dose, e.g. to administer equal doses
    • 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
    • A61M5/31501Means for blocking or restricting the movement of the rod or piston
    • A61M2005/31508Means for blocking or restricting the movement of the rod or piston provided on the piston-rod
    • 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
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31535Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31536Blocking means to immobilize a selected dose, e.g. to administer equal doses
    • A61M2005/3154Blocking means to immobilize a selected dose, e.g. to administer equal doses limiting maximum permissible dose
    • 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1094Tube connectors; Tube couplings at least partly incompatible with standard connectors, e.g. to prevent fatal mistakes in connection

Landscapes

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

Abstract

A feed system is intended for adjusting the feed volume of a flowable medium. The dosing system comprises a dosing syringe (1) with a syringe body (3) and a dosing plunger (4). A stopper is intended to adjustably limit the travel of a dosing plunger (4) in a syringe body (3) along a central longitudinal axis of a dosing syringe (1). The injector body (3) has an end injector cone (17) with a dispensing opening (18) for the medium to be dosed. The outer side wall of the syringe cone (17) comprises at least one rib (20) which increases the radial rib height above the main cone surface of the outer side wall. A syringe adapter as a component of a feeding system comprising a feeding syringe (1) for adjusting the feeding volume of a flowable medium, intended to connect the feeding syringe (1) to a container for supplying or removing the medium. The syringe adapter has a fluid channel for creating a flow connection between the interior of the container and the interior of the syringe body (3), wherein the fluid channel is defined by a silicone sleeve portion. The inner diameter of the fluid passage is defined by a silicone circumferential lip of the sleeve portion. The feed system results in a reduced risk of incorrect operation. The syringe adapter ensures a secure seal of the fluid channel with respect to the outer sidewall of a dosing syringe of the dosing system.

Description

Feeding system for adjusting the feeding volume of a flowable medium and syringe adapter as a component of such a feeding system
This patent application claims priority from german patent application DE 10 2021 204 338.0, the contents of which are incorporated herein by reference.
The present invention relates to a feed system for adjusting the feed volume of a flowable medium. The invention also relates to a syringe adapter as an integral part of such a feeding system.
A feed system of the type mentioned at the outset is known from EP 2 801 B1. A syringe adapter of the type mentioned at the outset is known from EP 2 985 015b 1. EP 1,324,794 B1 discloses an adjustable feed injector. US1,638,532 discloses various syringe head designs. US 4,275,729 discloses an adjustable feed injector. US2014/0 014 547a1 discloses a medicament container.
It is an object of the invention to further develop a feed system of the type mentioned at the outset, so that the risk of incorrect operation is reduced.
According to the invention, this object is achieved by a feed system having the features indicated in claim 1.
By providing at least one rib on the housing or side wall of the syringe cone, it is achieved that the syringe cone is no longer suitable for female luer connection. Thus, the use of a dosing syringe of the dosing system with a female luer fitting component that is not intended for this purpose is not possible. The ribs may be integrally molded to the syringe cone.
The outer side wall of the syringe cone may have more than one such rib, for example two ribs, three ribs, four ribs or more. Typically, the outer sidewall of the syringe cone has fewer than 10 such ribs.
The maximum adjustable dosing volume of the dosing syringe may be less than 50ml, may be less than 25ml, and may be less than 20ml. The maximum adjustable feed volume may be in the range of 10ml, in the range of 5ml, in the range of 2.5ml, or in the range of 1.0ml. The feed volume may be adjustable with an accuracy of 0.1 ml.
The feed system may be integrally made of plastic.
The axial rib of claim 2 has proven to prevent undesired connection with a female luer connector. The feed injector may be provided with a plurality of axial ribs on the injector cone, for example two, three, four, five or more axial ribs distributed circumferentially around the central longitudinal axis, and in particular evenly distributed. The number of such axial ribs is typically less than 10.
A rib height according to claim 3 has been demonstrated to avoid undesired connection with a female luer connector. The rib height may be in the range between 0.3mm and 0.6mm and in the range between 0.4mm and 0.5 mm.
The syringe adapter of claim 4 ensures a firm seal of the fluid channel with respect to the syringe body of the feed syringe in the region of the syringe cone despite the presence of the ribs. For this purpose, the silicone sleeve portion has sufficient flexibility to compensate for the radial step formed by the at least one rib.
The diametrical relationship according to claim 5 results in a firm seal of the main cone surface of the syringe cone of the feed syringe against the fluid channel at the level of the at least one rib. The difference between the smallest outer diameter of the main cone surface at the level of the at least one rib and the inner diameter of the fluid channel may be greater than 0.1mm, may be greater than 0.2mm, and may be in the range of 0.3 mm. The difference is typically less than 0.5mm or less than 1.0mm.
The silicone circumferential lip of claim 6 results in a particularly secure seal of the fluid channel relative to the syringe cone in the region of the at least one rib. The inner diameter of the fluid channel may be at least 5% smaller in the region of the silicone circumferential lip than in the axially adjacent region of the fluid channel. This ensures that the silicone circumferential lip actually forms a seal.
The design of the syringe adapter according to claim 7 is stable despite the use of a soft silicone inlay.
This applies in particular to the syringe adapter with locking body according to claim 8.
The venting channel according to claim 9 allows for safe reception of a flowing cover medium (cover medium) to be dosed from and/or safe dispensing of the medium into the container.
It is a further object of the present invention to provide a syringe adapter for a dosing system for adjusting the dosing volume of a flowable medium, wherein a firm seal of the fluid channel with respect to the outer side wall of the dosing syringe of the dosing system is provided.
According to the invention, this object is achieved by a syringe adapter having the features indicated in claim 10.
The advantages of the syringe adapter according to claims 10 and 11 correspond to those already explained above in particular in connection with claims 4 to 9.
The syringe adapter may have any additional features or combination of features of these claims. For example, the inner diameter of the fluid channel may be at least 5% smaller in the region of the silicone circumferential lip than in the axially adjacent region of the fluid channel.
Embodiments of the invention are described in more detail below with reference to the attached drawing figures, wherein:
fig. 1 shows a perspective view of a feed injector of a feed system for adjusting the feed volume of a flowable medium, for example an adjustable maximum feed volume of 10 ml.
FIG. 2 shows another perspective view of the feed injector from a direction opposite to FIG. 1;
fig. 3 shows an end view of the feed injector from the view direction III in fig. 1;
fig. 4 shows an axial longitudinal section along the line IV-IV in fig. 3;
FIG. 5 shows a perspective view of the injector body of the feed injector according to FIG. 1;
fig. 6 shows an end view of the syringe body from the viewing direction VI in fig. 5;
fig. 7 shows a side view of the syringe body, partly exploded in an axial section, as seen from the viewing direction VII of fig. 5;
FIG. 8 shows a cross-sectional view according to line VIII-VIII in FIG. 7;
fig. 9 shows an enlarged view of detail IX in fig. 7;
FIG. 10 shows in a view similar to FIG. 1 a feed syringe during application of an adhesive label prepared in the form of a tape-like label;
FIG. 11 shows a perspective view of a dosing plunger of the dosing syringe according to FIG. 1;
fig. 12 shows a side view of the feed plunger seen from the viewing direction XII of fig. 11;
fig. 13 shows a perspective view of a stop element of a stop device of a dosing syringe in a fully assembled state for adjustably defining the stroke of a dosing plunger in a syringe body;
fig. 14 shows the stop element according to fig. 13 in the unfolded state;
fig. 15 shows a perspective view of the latch element of the stopper of the feeding syringe;
FIG. 16 shows a perspective view of a syringe adapter of a dosing system for sealingly connecting a dosing syringe to a container for receiving or dispensing a medium;
fig. 17 shows an axial section according to line XVII-XVII in fig. 16;
fig. 18 shows a view of the adapter housing of the syringe adapter according to fig. 16, seen from the viewing direction XVIII in fig. 16;
FIG. 19 shows a cross-sectional view of the adapter housing according to line XIX-XIX in FIG. 18;
fig. 20 is a perspective view showing an installation state of the locking body of the syringe adapter seen from the same viewing direction as in fig. 16;
FIG. 21 shows a cross-sectional view according to line XXI-XXI in FIG. 20;
FIG. 22 shows a perspective view of a silicone inlay of the syringe adapter according to FIG. 16, also in an installed orientation as in FIG. 16;
FIG. 23 shows a perspective view of the silicone inlay from a viewing direction opposite to FIG. 22;
FIG. 24 shows an axial cross-sectional view of a silicone inlay according to line XXIV-XXIV in FIG. 22;
FIG. 25 shows a detail XXV in FIG. 24;
FIG. 26 shows, in a diagram similar to FIG. 1, other embodiments of a feed injector designed for a maximum feed volume of 5 ml;
FIG. 27 shows, in a view similar to FIG. 2, a feed injector according to FIG. 26;
FIG. 28 shows the feed injector according to FIG. 26 in a similar illustration to FIG. 3;
fig. 29 shows a cross-sectional view according to line XXIX-XXIX in fig. 28;
FIG. 30 shows, in a diagram similar to FIG. 1, a further embodiment of a feed injector designed for a maximum feed volume of 2.5 ml;
FIG. 31 shows a feed injector according to FIG. 30 in a similar illustration to FIG. 2;
FIG. 32 shows a feed injector according to FIG. 30 in a similar illustration to FIG. 3;
fig. 33 shows a cross-sectional view according to line XXXIII-XXXIII in fig. 32;
FIG. 34 shows, in a diagram similar to FIG. 1, a further embodiment of a feed injector designed for a maximum feed volume of 1.0 ml;
FIG. 35 shows a feed injector according to FIG. 34 in a similar illustration to FIG. 2;
FIG. 36 shows a feed injector according to FIG. 34 in a similar illustration to FIG. 3;
FIG. 37 shows a cross-sectional view according to line XXXVII-XXXVII in FIG. 36;
FIG. 38 shows a perspective view of the injector body of the feed injector according to FIG. 35 in a view similar to FIG. 5;
fig. 39 shows an end view of the syringe body from the viewing direction XXXIX in fig. 38;
fig. 40 shows a side view of the syringe body partially exploded in axial section, as seen from the viewing direction XL of fig. 38;
FIG. 41 shows a cross-sectional view according to line XLI-XLI in FIG. 38;
FIG. 42 shows the detail XLII in FIG. 38 in an enlarged form;
FIG. 43 shows a perspective view of a dosing plunger of the dosing syringe according to FIG. 34;
FIG. 44 shows a side view of the feed plunger from the view direction XLIV-XLIV in FIG. 43;
embodiments of a feeding system for setting or adjusting the feeding volume of a flowable medium will be described below with reference to fig. 1 to 25.
The main components of the feeding system are a feeding syringe 1 (see e.g. fig. 1) and a syringe adapter 2 (see fig. 16 and 17). The feed injector 1 and the injector adapter 2 are integrally made of plastic.
The feed injector 1 has an injector body 3, which is shown as a single component in fig. 5 to 8, and a feed plunger 4, which is shown as a single component in fig. 11 and 12. The syringe body 3 is made of polypropylene. The feed plunger 4 is made of polyethylene.
In the embodiment shown, the feed injector 1 is used to preset a maximum feed volume of 10 ml.
In order to adjustably limit the travel of the feed plunger 4 in the syringe body 3 along the central longitudinal axis 5 of the feed syringe 1 (see fig. 4), a stop means 6 is used. The latter comprises a pull limiting element 7 (see e.g. fig. 15) for limiting the maximum pull path of the feed plunger 4 in the direction of the central longitudinal axis 5 and a stop 8 (see in particular fig. 13 and 14), against which the pull limiting element 7 abuts in a pull position adjacent the feed plunger 4. The pull limiting element 7 is also referred to as a latch element. The basic operating mode of an embodiment of the locking device 6 is known from DE 2 801 B1.
The stop 8 has a sleeve-like basic shape and has two circumferential halves 8a, 8b which are connected to one another by an engagement lug 8c, so that the two circumferential halves 8a, 8b are joined in engagement about an engagement axis 8 d. When the stopper 8 is mounted, the engagement axis 8d extends at a distance parallel to the central longitudinal axis 5 of the feed injector 1. This engagement design of the stop 8 allows the two circumferential halves 8a, 8b of the stop 8 to be manufactured in one manufacturing process and in particular to be molded in one injection molding step. When assembling the stopper 8, the latter is placed around the plunger rod of the dosing plunger 4 in the initial open position according to fig. 14 and then the stopper is switched to the closed position according to fig. 13, wherein the two circumferential halves 8a, 8b are latchingly connected to each other and stably connected to the syringe body 3 via snap hooks protruding radially on the outside.
For example, in the illustration according to fig. 4, the pull-out limiting element is in its radially outer position just before the feed volume is preset by the engagement of the form-fit means 9 of the pull-out limiting element 7 with one of the form-fit receptacles or recesses of the plurality of form-fit recesses 10 in the outer side wall or shell wall of the feed plunger 4. In this radially outer position of the pull limiting element 7, the form-fitting means are disengaged from the form-fitting recess 10.
In order to clearly illustrate the amount of feed, a feed scale 11 (see fig. 1) is printed on the syringe body 3. Such printing is made by pad printing.
In order to avoid operating errors, the pull-out limiting element 7 is covered by the band-shaped tag 12 in a radially outer initial position according to fig. 4. The band-shaped label 12 has a release sheet 13 (see fig. 1) in the application position. The latter with information printing, which is visible as shown in fig. 2.
Fig. 10 shows a snapshot when applying the tape-like label 12 during final assembly of the feed injector 1. The circumferential orientation of the band-shaped tag 12 with respect to the circumferential position of the drawing limiting element 7 is such that the adhesive surface 14 of the band-shaped tag 12 is not located on the drawing limiting element 7.
The syringe body 3 has an integrally moulded circumferential collar 15 which forms two operating wings. The dosing plunger 4 in turn has a circular circumferential collar 16 at the end side, which protrudes beyond the syringe body 3. The two circumferential collars 15, 16 allow for simple operation of the feed syringe 1 to pull the feed plunger 4 and push the feed plunger 4 into the syringe body 3. In order to simplify the operation of the feed injector 1 when the feed plunger 4 is pulled, the end surface of the circumferential collar 15 of the injector body 3 is also provided with corrugations, which are visible, for example, in the viewing direction of fig. 2 and 5.
The syringe body 3 has a syringe cone 17 on the dispensing side or end side. The syringe cone 17 (see in particular fig. 1 and 9) defines a dispensing opening 18 of the syringe body 3 for the medium to be dosed. The outer side wall 19 of the syringe cone 17 has at least one rib 20 designed as an axial rib, which rises above the main cone surface 21 of the outer side wall 19 by a radial rib height RH (see fig. 9).
The feed injector 1 according to the embodiment of fig. 1 to 15 has a total of three such ribs 20a, 20b, 20c (see e.g. fig. 6) which rise radially in the same way above the main cone surface 21 of the injector cone 17. These three axial ribs 20a to 20c (=20i) are evenly distributed in the circumferential direction around the central longitudinal axis 5 of the syringe body 3. Depending on the design of the syringe body, a different number of ribs 20i may also be provided, for example two to ten such ribs 20i (two ribs, four ribs, five ribs, six ribs, seven ribs, eight ribs, nine ribs, ten ribs). The rib height RH in the illustrated embodiment is about 0.5mm and may be in the range between 0.2mm and 0.8mm, in the range between 0.3mm and 0.6mm, in the range between 0.4mm and 0.5mm, and also in the range around 0.4 mm.
The outer diameter of the syringe cone 17 in the region of the ribs 20 can be in the range between 5.7mm and 6.0mm at maximum. In the region between the ribs 20, the outer diameter of the syringe cone at the axial height of the ribs 20 may be in the range between 5.4mm and 5.7 mm.
The syringe adapter 2 will be explained in more detail below with reference to fig. 16 to 25.
The syringe adapter 2 has a fluid channel 24 for forming a flow connection between the interior of the container 25 shown in section in fig. 17 and the interior of the syringe body 3, in particular the dispensing opening 18 of the syringe cone 17. The inner diameter of the fluid passage 24 is defined by a sleeve portion 26 made of silicone. Via this sleeve portion 26, the syringe cone 17 sealingly adjoins the fluid channel 24 in the connection-fitting position, the sleeve portion 26 also providing a seal against the syringe cone 17 in the region of the rib 20i, in particular in the region of the radial step formed by the rib 20i.
The sleeve portion 26 is part of a silicone inlay 27, which is shown in its entirety in, for example, fig. 22 and 23. The silicone inlay 27 is inserted into the adapter housing 28 of the syringe adapter 2. The locking body 29 serves to hold the silicone inlay 27 in the adapter housing 28. The adapter housing 28 is shown as a single component in fig. 18 and 19. The locking body 29 is shown as a single component in fig. 20 and 21.
The silicone material of silicone inlay 27 has a shore a hardness of 40. Alternatively, different shore a hardness in the range between 30 and 50, and in particular in the range between 35 and 45, may be provided. The silicone material of the silicone inlay 27 includes polydimethylsiloxane having vinyl groups and at least one auxiliary agent as component a, and polydimethylsiloxane having functional groups and at least one auxiliary agent as component B.
The adapter housing 28 is made of polyethylene, in particular LDPE (low density polyethylene). The locking body 29 is made of polypropylene.
In the assembled position, the locking body 29 latchingly engages a circumferential latching receptacle or recess 29a in the inner housing wall of the adapter housing 28.
In addition to the fluid channel 24, the syringe adapter 2 also has a vent channel 30 for providing air communication between the interior of the container 25 and the container environment 31 (see fig. 17).
The basic structure of such a syringe adapter with a fluid channel and at least one ventilation channel is known from EP 2 985 015 B1.
The vent passage 30 includes a check valve 32 configured as a beak valve that provides a direction of venting from the container environment 31 through the vent passage 30 into the interior of the container 25. The check valve 32 is an integral part of the silicone inlay 27.
The fluid channel 24 and the vent channel 30 each have three channel portions 24a, 24b, 24c, 30a, 30b, 30c extending from the container environment 31 to the interior of the container 25, which are formed in this order in the adapter housing 28, the silicone inlay 27, and the locking body 29.
In the sleeve portion 26, the inner diameter ID of the fluid channel 24 is defined by a silicone circumferential lip 33 of the sleeve portion 26 of the silicone inlay 27. The inner diameter ID of the fluid channel 24 is at least 5% smaller in the region of the silicone circumferential lip 33 than in the axially adjacent region of the fluid channel 24, and in particular at least 5% smaller than in the axially adjacent region of the sleeve portion 26.
The inner diameter ID of the silicone inlay 27 is in the range between 5.0mm to 5.2mm and may be, for example, 5.1mm.
To prevent circumferentially oriented rotation of the silicone inlay 27 in the adapter housing 28, the silicone inlay has an external axial groove 34 that mates with a complementary axial rib 35 (see fig. 18) of the adapter housing 28 when the silicone inlay 27 is installed. The axial grooves 34 and the axial ribs 35 are distributed in the circumferential direction so that the silicone inlay 27 in the adapter housing can have only exactly one circumferential orientation.
A circumferential lug 36 is integrally formed on the outside of the locking body 29 and cooperates with a corresponding circumferential recess 36a in the inner housing wall of the adapter housing 28 for corresponding circumferential positioning and anti-rotation locking of the locking body 29 against the adapter housing 28 and the silicone inlay 27.
Initially, the fluid channel 24 is closed by a predetermined burst skin 37 through the silicone inlay 27, which is pierced when the syringe cone 17 enters the fluid channel 24. The predetermined fracture skin 37 is supported by four quadrant shaped support tabs 38 of the silicone inlay 27 which flip out towards the container 25 when the syringe cone 17 is pierced, releasing the fluid channel 24.
The feed system was prepared and used as follows:
first, the feed syringe 1 and the syringe adapter 2 are assembled, forming an initial configuration shown in particular in fig. 4 (feed syringe 1) and 17 (syringe adapter 2). When assembling the syringe adapter 2, the silicone inlay 27 is inserted into the adapter housing 28 and positioned via the mating axial groove 34 and axial rib 35. Thereafter, the locking body 29 is inserted into the adapter housing 28 and positioned via the mating circumferential lugs 36 and circumferential recesses 36a, and latchingly engaged in the latching recesses 29a.
Check valve 32 is operable by piercing once. To adjust the dosing volume, the tape-shaped label 12 is first removed from the syringe body 3 by means of the pull tab 13, and then the dosing plunger 4 is pulled up to the required distance for the desired dosing volume. In this position, the pull-out limiting element 7 is then displaced radially inwards so that the form-fitting device 9 engages with and engages in the form-fitting recess 10 to be adjusted. The dosing plunger can now again be pushed completely into the syringe body 7 and the dosing syringe together with the syringe cone 17 inserted into the fluid channel 24 of the syringe adapter 2.
The assembled syringe adapter 2 is then placed on the container with the medium to be dosed.
When the syringe cone 17 is inserted into the fluid channel 24, the predetermined fracture surface layer 37 is pierced, and the syringe cone 17 axially abuts in the fluid channel 24 in such a way that: so that the axial rib 20i starts to lie on the level of the silicone circumferential lip 33 of the sleeve portion 26 of the silicone inlay 27. The soft silicone circumferential lip 33 provides sufficient radial circumferential compensation such that the silicone circumferential lip 33 seals against the outer sidewall 19 of the syringe cone 17 over the entire circumference despite the presence of the axial rib 20i. In this sealing position, the dosing plunger 4 in the syringe body 3 can now be pulled to a predetermined dosing stop, whereby the dosing syringe 1 is filled with a preset dosing volume of flowable medium. Here, the vent channel 30 provides venting of the interior of the container 25 to compensate for the withdrawn feed volume.
The inner diameter ID of the fluid channel 24 is smaller than the minimum outer diameter AD of the main cone surface 21 at the level of the at least one rib min (see FIG. 9). This diameter difference AD min -ID is greater than 0.1mm. According to syringe cone 17 and injectionThe diameter difference may be greater than 0.2mm, may be greater than 0.3mm, and may also be greater than the design of the sleeve portion 26 of the injector adapter 2. The diameter difference is typically less than 1.0mm.
With reference to fig. 26 to 29, further embodiments of the feed injector 40 will be described below, which replace the feed injector 1 for adjusting the feed volume to a maximum of 5ml. Those corresponding to the components and functions described above with reference to fig. 1 to 25 have the same reference numerals and will not be discussed in detail.
The barrel volume of the syringe body 3 of the feed syringe 40 is smaller than the barrel volume of the feed syringe 1 due to the smaller maximum feed volume. The outer diameter of the feed plunger 4 is adapted to the correspondingly reduced inner diameter of the syringe body 3 of the feed syringe 40.
With reference to fig. 30 to 33, further embodiments of the feed injector 41 for adjusting the feed volume to a maximum of 2.5ml will be described below, instead of the feed injector 1. Those corresponding to the components and functions described above with reference to fig. 1 to 25 have the same reference numerals and will not be discussed in detail.
The cylinder volume of the syringe body 3 of the feed syringe 41 is smaller than the cylinder volume of the feed syringe 1, since the maximum feed volume is smaller. The outer diameter of the feed plunger 4 is adapted to the correspondingly reduced inner diameter of the syringe body 3 of the feed syringe 41.
In addition, in the case of the feed syringe 41, the drawing stroke of the feed plunger 4 within the syringe body 3 is limited. Followed by a corresponding arrangement of the form-fitting recess 10 on the feed plunger 4.
With reference to fig. 34 to 44, further embodiments of the feed injector 42 will be described below, which replace the feed injector 1 for adjusting or setting the feed volume to a maximum of 1.0ml. Those corresponding to the components and functions described above with reference to fig. 1 to 25 have the same reference numerals and will not be discussed in detail.
In the feed syringe 42, the syringe body 3 and the feed plunger 4 are each axially divided into a volume portion 3a/4a and a feed portion 3b/4b formed thereon. The volumetric portions 3a and 4a of the syringe body and dosing plunger 4 serve to limit the dosing volume of the flowable medium. The syringe body 3 and the dosing sections 3b and 4b of the dosing plunger 4 are used to adjust the dosing volume.
Between the volume portion 3a and the dosing portion 3b, the syringe body 3 has a circumferential step 43 and tapers via its syringe body towards the volume portion 3 a. The diameter of the feed portion 3b corresponds to the diameter of the syringe body 3, for example of the feed syringes 40 and 41, so that the stop device 6 can be accommodated therein in particular. In contrast, the inner diameter of the syringe body 3 tapers in the volume portion 3a in order to achieve a corresponding dosing accuracy with a smaller maximum dosing volume of 1.0mm.
For the dosing syringe 42, the stop device 6 has exactly nine positive-locking recesses 10, by means of which an adjustment accuracy of a dosing volume of 0.1ml is achieved.
In the dosing plunger 4 of the dosing syringe 42, the volume portion 4a merges into the dosing portion 4b via a circumferential step 44. The volume portion 4a has a top end portion 45 which is located in the interior volume of the syringe cone 17 of the volume portion 3a of the syringe body 3 when the dosing plunger 4 is fully pushed out. Between the main part 46 and the top end part 45 of the volume part 4a, the dosing plunger 4 of the dosing syringe 42 has a sealing part 47 designed as a circumferential collar for sealing against the inner wall of the volume part 3a of the syringe body 3.
The main portion 46 of the volumetric portion 4a of the dosing plunger 4 of the dosing syringe 42 has a cross-shaped cross-section. The radial extension of the intersecting ribs 48 of the main portion 46 tapers adjacent the sealing portion 47 by means of corresponding rib steps 49. The rib step 49 serves to protect the sealing portion 47 from static influences of the intersecting ribs 48.
In the region of the circumferential step 44, the dosing plunger 4 has a further circumferential collar 50 for guiding the stroke of the dosing plunger 4 by cooperation with the inner wall of the dosing portion 3b of the syringe body 3.
The syringe adapter 2 is designed to mate with any of the embodiments of the feed syringe 1, 40, 41, 42 previously described.

Claims (11)

1. A dosing system for adjusting a dosing volume of a flowable medium, comprising a dosing injector (1;
40;41;42)
having a syringe body (3) and a feed plunger (4),
having a stop means (6) for adjustably limiting the travel of the dosing plunger (4) in the syringe body (3) along the central longitudinal axis (5) of the dosing syringe (1; 40;41; 42),
wherein the injector body (3) has an end injector cone (17) with a dispensing opening (18) for the medium to be metered,
-wherein the outer side wall (19) of the syringe cone (17) comprises at least one rib (20) which increases the radial Rib Height (RH) above the main cone surface (21) of the outer side wall (19).
2. A feeding system according to claim 1,
characterized in that the at least one rib (20) is designed as an axial rib.
3. The feeding system according to claim 1 or 2,
characterized in that the Rib Height (RH) is in the range of 0.2mm to 0.8 mm.
4. A feeding system according to any one of claim 1 to 3,
characterized by a syringe adapter (2) for connecting the feed syringe (1; 40;41;
42 Is sealingly connected to a container (25) for receiving or dispensing said medium,
wherein the syringe adapter (2) comprises a fluid channel (24) for providing a flow connection between the interior of the container (25) and the interior of the syringe body (3),
-wherein the fluid channel (24) is defined by a sleeve portion (26) of silicone.
5. A feeding system according to claim 4,
characterized in that the Inner Diameter (ID) of the fluid channel (24) is smaller than the minimum outer diameter (AD) of the main conical surface (21) at the level of the at least one rib (20) min )。
6. The feeding system according to claim 4 or 5,
characterized in that the Inner Diameter (ID) of the fluid channel (24) is delimited by a silicone circumferential lip (33) of the sleeve portion (26).
7. A feeding system according to any one of claims 4 to 6,
characterized in that the syringe adapter (2) comprises an adapter housing (28) for insertion into a recess of the container (25), wherein the silicone sleeve portion (26) is part of a silicone inlay (27) which is inserted into the adapter housing (28).
8. A feeding system according to claim 7,
characterized in that the syringe adapter (2) comprises a locking body (29) for holding the silicone inlay (27) in the adapter housing (28).
9. The feeding system according to any one of claims 4 to 8,
wherein the syringe adapter (2) comprises at least one venting channel (30) for providing an air connection between the interior of the container (25) and a container environment (31).
10. A syringe adapter (2) as an integral part of a feed system comprising a feed syringe (1; 40;41; 42) for adjusting the feed volume of a flowable medium, wherein the syringe adapter (2) is designed for connecting the feed syringe (1; 40;41; 42) to a container (25) for receiving or dispensing the medium,
comprising a fluid channel (24) for providing a flow connection between the interior of the container (25) and the interior of the syringe body (3),
wherein the fluid channel (24) is delimited by a sleeve portion (26) of silicone,
-wherein the Inner Diameter (ID) of the fluid channel (24) is defined by a silicone circumferential lip (33) of the sleeve portion (26).
11. The syringe adapter of claim 10,
characterized in that a silicone circumferential lip (33) for sealing the fluid channel (24) with respect to the syringe body (3) of the feed syringe (1; 40;41; 42) is formed in the region of the syringe cone (17) of the feed syringe (1; 40;41; 42).
CN202280031742.3A 2021-04-30 2022-04-07 Feeding system for adjusting the feeding volume of a flowable medium and syringe adapter as a component of such a feeding system Pending CN117677415A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102021204338.0 2021-04-30
DE102021204338.0A DE102021204338A1 (en) 2021-04-30 2021-04-30 Dosing system for setting a dosing volume of a free-flowing medium and syringe adapter as part of such a dosing system
PCT/EP2022/059183 WO2022228848A1 (en) 2021-04-30 2022-04-07 Dosing system for adjusting a dosing volume of a flowable medium, and syringe adapter as a component of such a dosing system

Publications (1)

Publication Number Publication Date
CN117677415A true CN117677415A (en) 2024-03-08

Family

ID=81581189

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202280031742.3A Pending CN117677415A (en) 2021-04-30 2022-04-07 Feeding system for adjusting the feeding volume of a flowable medium and syringe adapter as a component of such a feeding system

Country Status (5)

Country Link
EP (1) EP4329845A1 (en)
CN (1) CN117677415A (en)
DE (1) DE102021204338A1 (en)
IL (1) IL308028A (en)
WO (1) WO2022228848A1 (en)

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1638532A (en) 1924-02-02 1927-08-09 Kallmeyer Ernst Syringe head
DE2801382A1 (en) 1978-01-13 1979-07-19 Rudolf Zur Bonsen Fa Pumping channel for liquid metal pumps - has junction element between connecting pipe and middle piece, divided by partition into two chambers
US4275729A (en) 1979-10-29 1981-06-30 Jules Silver Adjustable dosage syringe
US6562007B1 (en) 2000-09-28 2003-05-13 Bayer Healthcare Llc Adjustable dosage syringe
CN103458852B (en) 2011-03-28 2015-05-20 泰尔茂株式会社 Drug storage container
ITMI20111013A1 (en) * 2011-06-06 2012-12-07 Lorenzo Mattioli CONNECTOR FOR A PERIDURAL INFUSION LINE
DE102013208390A1 (en) 2013-05-07 2014-11-13 Raumedic Ag dosing
DE102014215901A1 (en) 2014-08-11 2016-02-11 Raumedic Ag syringe adapter
US10945926B2 (en) * 2017-04-25 2021-03-16 Claborn Kennard Locking enteral feeding system
US11266573B2 (en) * 2017-05-01 2022-03-08 Sympfiny Llc System for dosing and dispensing medication

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WO2022228848A1 (en) 2022-11-03
IL308028A (en) 2023-12-01
EP4329845A1 (en) 2024-03-06
DE102021204338A1 (en) 2022-11-03

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