WO2019149328A1 - Valve pour dispositif d'injection, et dispositif d'injection avec une telle valve - Google Patents

Valve pour dispositif d'injection, et dispositif d'injection avec une telle valve Download PDF

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Publication number
WO2019149328A1
WO2019149328A1 PCT/DK2019/050034 DK2019050034W WO2019149328A1 WO 2019149328 A1 WO2019149328 A1 WO 2019149328A1 DK 2019050034 W DK2019050034 W DK 2019050034W WO 2019149328 A1 WO2019149328 A1 WO 2019149328A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
connecting part
container
injection
drug
Prior art date
Application number
PCT/DK2019/050034
Other languages
English (en)
Inventor
Claus Schmidt MØLLER
Original Assignee
Subcuject Aps
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
Priority claimed from DKPA201870111A external-priority patent/DK179818B1/en
Application filed by Subcuject Aps filed Critical Subcuject Aps
Priority to EP19703006.7A priority Critical patent/EP3746174A1/fr
Priority to US16/964,306 priority patent/US20200360235A1/en
Publication of WO2019149328A1 publication Critical patent/WO2019149328A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting ports
    • A61J1/2062—Connecting means having multiple connecting ports with directional valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
    • A61M2005/312—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
    • 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
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/288—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened by piercing without internal pressure increase
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula

Definitions

  • the invention relates to a valve for an injection device for subcutaneous injection of a therapeutic drug, wherein the valve provides a fluid pathway between a drug-filled 5 container and a drug distribution system for distributing the drug to the injection site during use of the device. Furthermore, the invention relates to an injection device comprising such a valve.
  • WO 2017/129191 discloses a wearable injection device using the movement of the plunger to retract the needle after the injection.
  • a hol- low needle is pushed through a septum on a cartridge by a movable part and, at the5 same time, a hypodermic needle is inserted in the patient and locked in position by the movable part.
  • the hollow needle is pushed a distance out of the cartridge and, as this movement is transferred to the movable part, the hypo- dermic needle is set free to be retracted by a spring.
  • a disadvantage of this configura- tion is that only cartridges with a septum can be used in the device, while part of the0 industry prefers a solution that allows syringes without a needle to be used in the de- vice.
  • Another disadvantage is that particles from the septum may be introduced to the drug when the needle penetrates the septum.
  • the present invention relates to a valve for an injection device, which valve is ar
  • valve is substantially cylindrically shaped and is arranged to be at least partly positioned within an outlet portion of the container so that, in an initial configu- 5 ration, the valve tightly closes the outlet portion, wherein the valve is arranged to be moved through a first distance in a first direction partly into the container, whereby fluid communication is established through the outlet portion of the container, and wherein the valve is further arranged to be moved through a second distance in a sec- ond direction opposite of the first direction.
  • the fluid communication through the outlet por tion is established at least partly by means of internal fluid channels through the valve.
  • the fluid communication through the outlet por-5 tion is established at least partly along an outer surface of the valve.
  • the fluid communication through the outlet por tion is established at least partly by means of external and open fluid channels ar ranged on the outside of the valve.
  • valve enables for obtaining an injection device, which does not comprise a needle for penetrating a septum of the drug-filled container, whereby is provided a bigger surface that is more suited for being pushed by a rubber plunger than a needle tip.
  • an injection device for subcutaneous injec- tion of a therapeutic drug comprising a drug-filled container defining a centre axis and comprising an outlet portion and a movable plunger, a distribution system for distrib- uting the drug to an injection site comprising a connecting part movable along the 0 centre axis, and a valve as described above, which is at least partly positioned in the outlet portion of the container, wherein, in an initial configuration, the valve tightly closes the outlet portion of the container, wherein, during activation of the device, the connecting part causes the valve to move through a first distance in a first direction partly into the container, whereby fluid communication is established through the out- 5 let portion of the container between the container and the distribution system, and wherein, at the completion of the injection, the plunger in the container pushes the valve through a second distance in a second direction opposite of the first direction, thereby moving the connecting part through the same second distance.
  • the second distance is shorter than the first dis tance.
  • the distribution system further comprises a deliv- ery part with a hypodermic needle for insertion at an injection site at activation of the device, and a spring means compressed during the insertion, wherein the connecting part is arranged to maintain the delivery part in an exposed position in relation to the 5 injection device during the injection, and wherein the connecting part is arranged to release the delivery part to be moved back into a retracted position within the injec- tion device by the compressed spring means, when the connecting part is moved by the valve at the completion of the injection.
  • a very simple retraction mechanism for a wearable injection device is provid- ed.
  • the movement of the connecting part at the com pletion of the injection is electronically detected.
  • data regarding the injection can be stored and/or transmitted, e.g., to health care personnel.
  • the valve in the initial configuration, is sealed by0 means of a breakable or removable seal.
  • the connecting part and the outlet portion of the container are sealed to each other.
  • the valve does not have to seal to the drug-filled container during injection.
  • a sealing may also be arranged directly between the connecting part and the valve.
  • Fig. 1 is a perspective view of a wearable injection device according to an0 embodiment of the invention
  • Fig. 2 is an exploded view of a distribution system of a wearable injection device according to an embodiment of the invention
  • 5 Fig. 3 is a perspective view of a drug-filled container and a distribution system of an injection device in communication with each other through a valve according to an embodiment of the invention in a first state
  • 0 Fig. 4 is a perspective view of the same drug-filled container and distribu- tion system in a second state
  • Fig. 5 shows a perspective view of the same drug-filled container and dis- tribution system in a third state
  • Fig. 6 is a schematic cross-sectional view of a drug-filled container, a valve according to a first embodiment of the invention and a con necting part in a first state
  • Fig. 7 is a schematic cross-sectional view of the same container, valve and connecting part in a second state
  • Fig. 8 is a schematic cross-sectional view of the same container, valve and connecting part in a third state
  • Fig. 9 is a schematic cross-sectional view of the same container, valve and connecting part in a fourth state
  • 0 Fig. 10 is a schematic cross-sectional view of a drug-filled syringe, a valve according to a second embodiment of the invention and a connect- ing part in a first state
  • Fig. 11 is a schematic cross-sectional view of the same syringe, valve and5 connecting part in a second state
  • Fig. 12 is a schematic cross-sectional view of the same syringe, valve and connecting part in a third state
  • Fig. 13 is a schematic cross-sectional view of the same syringe, valve and connecting part in a fourth state
  • Fig. 14 is a schematic cross-sectional view of a drug-filled syringe, a valve according to a third embodiment of the invention and a connecting5 part in a first state,
  • Fig. 15 is a perspective view of the valve from Fig. 14
  • Fig. 16 is a schematic cross-sectional view of the syringe, valve and con0 necting part from Fig. 14 in a second state
  • Fig. 17 is a schematic cross-sectional view of the same syringe, valve and connecting part in a third state
  • Fig. 18 is a schematic cross-sectional view of the same syringe, valve and connecting part in a fourth state.
  • Functional units which are described and shown to comprise a number of parts fixed together and acting as one part, may be configured as one single part or comprise a 5 more or less separate parts divided in a different way than described and shown with out falling outside the scope of the invention.
  • drug-filled container 102 or just“container” covers all kinds of vessels and containers, from which a drug can be pressed out by means of a movable plunger0 124, including all kinds of cartridges and syringes 202 made from glass or polymer.
  • actuator is meant a drive mechanism that can deliver the necessary force to drive the drug out of the container 102, 202.
  • This drive mechanism can be configured as a mechanical, hydraulic, chemical or electronic mechanism.
  • the term“distribution system” 101 covers all mechanisms, which by actuation of the device 100 can direct the drug from the drug-filled container 102, 202 to the injection site. This also includes multiple needle- or catheter-based embodiments.
  • the term“drug” is to be understood as biologically or small molecule medicaments to be inserted in an individual to cure a disease, for which the medicament is intended.
  • Fig. 1 is a perspective view of a wearable injection device 100 according to an embod- iment of the invention.
  • a drug-filled container 102 can be seen through an opening0 126 in the outer housing parts.
  • the push button 127 which forms part of a distribu- tion system 101, is preferably made of a soft and flexible material and acts upon one or more of the inner parts (not shown in this drawing) of the distribution system 101, when it is pushed.
  • the illustrated device 100 is a preferred device 100 to be used with the valve 116 of the invention, but the valve 116 can also be configured for being used5 in other types of injection devices, such as auto injections.
  • FIG. 2 an exploded view of a distribution system 101 of a wearable injection device
  • the distribution system 101 can be used as reference in the following explanation of the relationship between0 the distribution system 101 and the drug-filled container 102.
  • the distribution system 101 comprises at least a connecting part 103 with an opening 108, which is connecting to the drug-filled container 102 during activation, a delivery part 104 holding a needle 112 for insertion in the user at the injection site, an O-ring 106 for making a tight connection between the connecting part 103 and the delivery part5 104, and a transmitting part 105 transmitting an activating force from the user to the delivery part 104 to insert the needle 112.
  • Fig. 3 The function of the distribution system 101 and the relation to the drug-filled contain er 102 with the valve 116 can be seen in Fig. 3.
  • the valve 116 In an initial position, the valve 116 is0 protruding partly into the opening 108 of the connecting part 103, but the connecting part 103 and the drug-filled container 102 are not yet in fluid communication.
  • a sur face 115 of the transmitting part 105 abuts onto a surface 114 of the connecting part 103, and an angled surface 128 (visible in Fig. 4) of a protrusion 113 on the transmit ting part 105 abuts onto a corresponding angled surface 110 (visible in Fig. 2) of the 5 delivery part 104.
  • Fig. 3 The function of the distribution system 101 and the relation to the drug-filled contain er 102 with the valve 116 can be seen in Fig. 3.
  • the valve 116 In an initial position, the valve 116 is0 protruding partly into the opening 108 of the connecting part 103
  • valve 116 can be discerned between the drug-filled container 102 and the connecting part 103 along with an O-ring 117 for securing a tight connection between the drug-filled container 102 and the distribution system 101 during injection.
  • the delivery part 104 is in a retracted position and there is no fluid communication between the connecting part 103 and the delivery part 104 yet.
  • the device 100 has been activated.
  • the user has pushed the flexible push button 127 (see Fig. 1), which in turn has pushed and moved the connecting part 103 and pushed and opened the valve 116 (as will be explained below).
  • the distribution system 101 and the drug-filled container 102 are now in fluid communication.
  • the 5 delivery part 104 is only capable of moving up and down relative to the device 100, and consequently it has been pushed downward by the transmitting part 105, which has been moved by the connecting part 103 because of the abutting surfaces 114, 115.
  • the transmitting part 105 has thereby passed the delivery part 104 and has been locked in this position, and the needle 112 has been inserted at the injection site.
  • A0 spring (not shown) between the delivery part 104 and the housing of the device 100 has been compressed during the activation, and the delivery part 104 is maintained in this position by a blocking surface 107 of the connecting part 103 resting on a surface 111 on the delivery part 104 (visible in Fig. 2).
  • An inlet hole (not shown) in the deliv ery part 104 is now aligned with the outlet hole 109 (visible in Fig. 2) in the moving5 part 103 and, due to the O-ring 106, a tight fluid connection between the connecting part 103 and the delivery part 104 has now been established. This means that, in turn, a tight fluid communication between the drug-filled container 102 and the injection site has been established.
  • the injection has been completed and the valve 116 has caused the connect- ing part 103 of the distribution system 101 to move a short distance back and away from the drug-filled-container 102 (as will be explained in details below).
  • This has moved the blocking surface 107 of the connecting part 103 away from the surface 111 5 of the delivery part 104.
  • the transmitting part 105 has not moved back along with the connecting part 103, the spring (not shown) compressed during the activa- tion of the device 100 has caused the delivery part 104 to be moved up and the needle 112 to be retracted from the injection site.
  • the fluid commu- nication between the connecting part 103 and the delivery part 104 has been discon- 0 nected.
  • Fig. 6 is a cross-sectional view of the initial position of the parts before the device 100 is actuated.
  • the valve 116 is initially positioned in an outlet section 123 of 5 the drug-filled container 102.
  • the cylindrical outlet section 123 encloses the openings of a transverse channel 120 connected with an axial channel 119 with an opening pointing away from the container 120, and there is no fluid communication between the drug-filled container 102 and the distribution system 101 in this initial position.
  • An O-ring 118 on the valve 116 ensures a tight separation between the openings of the0 transverse channel 120 and the drug in the container 102.
  • the connecting part 103 has not yet been moved and the O-ring 117 outside the outlet section 123 has not yet made a tight connection between the opening 108 on the connecting part 103 and the drug-filled container 102.
  • the connecting part 103 has been moved during an actuation sequence carried out by the user of the device 100.
  • the O-ring 117 is now securing a tight connection between the connecting part 103 (and thereby the distribution system 101) and the drug-filled container 102, and the inlet of a fluid channel 130 in the con necting part 103 is connected to the outlet of the axial fluid channel 119.
  • the connecting part 103 may seal to the valve 116 direct- iy.
  • FIG. 8 A fully established connection between the connecting part 103 and the drug-filled 5 container 102 can be seen in Fig. 8, wherein a continued movement of the connecting part 103 as part of the activation sequence has moved the valve 116 relative to the drug-filled container 102. This has exposed the openings of the transverse channel 120 to the drug inside the drug-filled container 102, and a tight fluid communication to the distribution system 101 has been established.
  • a flange 121 on the valve 116 0 stops and controls the longitudinal movement of the valve.
  • Fig. 9 shows the scenario wherein the injection has been completed.
  • the plunger 124 has moved to the end of the container 102 causing the content to be ex- pelled, and the plunger surface 125 has abutted onto the valve surface 122 and pushed 5 the valve 116 through a short distance.
  • this has caused the valve 116 to move the connection part 103 as well and to set the delivery part 104 free to be moved up, whereby the needle 112 has been retracted to a non-exposed position inside the device 100 and the fluid communication between the connecting part 103 and the delivery part 104 has been disconnected.
  • the plunger 1240 movement can either be stopped by the valve 116 or by the continued movement of the plunger against the narrow outlet section 123, or the movement of the connecting part 103 can be adapted to stop the actuator from applying pressure to the plunger 124.
  • the displacement of the connecting part 103 or an associated part can be used as a tactile signal to inform the user that the injection has been completed or it may initiate a mechanical or electronically generated visual or audible signal.
  • the movement of the connecting part 103 or an associated part in the end of the in jection may also be detected electronically and stored and/or transmitted to a server to0 help health care personnel in assuring that the patient is in compliance.
  • a server to0 help health care personnel in assuring that the patient is in compliance.
  • internal channels 119, 120 in the valve 116 external and open channels on the outside or simply smaller diameters on the valve to allow passage of the drug could be envisioned.
  • valve 116 can be configured to be used with a hand-held auto injection, e.g. driven by a spring, and the connecting part 103 may initiate the retraction of the needle 112 or, alternatively, give an acoustic and/or tactile signal to inform the user that the injection has been completed.
  • a signal may also be gen- 0 erated by the valve 116 itself or by an intermediate part.
  • FIG. 10 Another embodiment of the invention, which is usable with a standard syringe 202, and which, thereby, is more suitable for existing filling lines is illustrated in Figs. 10- 13.
  • a syringe 202 with an outlet section 223 and a luer lock connection 2315 or another suitable type of connection is connected with a valve housing 232 via the luer lock.
  • a sealing part 233 of, e.g., silicone is provided between the luer lock surfaces of the syringe 202 and the valve housing 232.
  • the valve housing 232 has a cylindrical opening throughout its length with the same centre axis as the syringe inlet hole 238,0 which cylindrical opening is divided into an outlet portion 234 with a first diameter near the opening pointing away from the syringe 202 and an inlet portion 235 with a second and larger diameter closer to the syringe 202.
  • a valve 216 has a first portion 236 that protrudes through the syringe inlet hole 238 and partly into the outlet section 223 and has an axial fluid channel 219 extending through the first portion 2365 throughout the entire length thereof.
  • a second portion 237 of the valve 216 has a transverse fluid channel 220 perpendicular to and connected with the axial fluid chan nel 219, and an O-ring 218 is arranged next to the openings of the transverse fluid channel 220.
  • the device 100 and, thereby, the valve 216 is in its initial posi tion and the O-ring 218 tightens the outlet portion 234 of the valve housing 232 tight-0 ly.
  • the first portion 236 of the valve 216 is enclosed by the syringe inlet hole 238 and the second portion 237 protrudes out of the valve housing 232.
  • Fig. 12 further movement of the connecting part 203 has moved the valve 216 a 5 first distance and the O-ring 218 on the valve 216 has been moved into the inlet por tion 235 with the larger diameter of the valve housing 232.
  • Drug from the syringe 202 can now flow through the axial fluid channel 219 in the first portion of the valve 216, further through the transverse fluid channel 220 and around the O-ring 218 and the flange on the valve 216 (partly open for passage), through a fluid channel 239 in the0 valve 216, which is now in connection with the fluid channel 230 in the connecting part 203, and into the distribution system 101.
  • the first portion 236 of the valve 216 is now partly inside the drug-filled volume of the syringe 202, and as the plunger 224 approaches the completion of is movement through the syringe 202 at the completion of the injection, the plunger surface 225 abuts onto the valve surface 222.5 Further movement of the plunger 224 pushes the valve 216 and the connecting part
  • FIG. 14 A further embodiment usable with a standard cartridge 302 with a plunger 324, which is normally used in multiple dose injection devices, is illustrated in Figs. 14 through 17.
  • a valve housing 332 which is preferably made of an elastomer, is tight- 5 ly mounted onto a collar 323 of the cartridge 302 so that a sterile barrier is provided between the two parts.
  • the valve housing 332 has a cylindrical opening throughout its length and in serial connection with inlet hole of the cartridge 302.
  • a valve 316 com prising a valve body 340 and a valve head 345 fixed to each other (as illustrated in Fig. 15) is arranged within the cylindrical opening of the valve housing 332 and fixed0 in an initial position via a small flange 321 on the valve body 340 arranged in a corre- sponding groove in the valve housing 332.
  • the valve head 345 protrudes into the opening of the cartridge 302 and the mainly cylindrical surface 318 on the valve head 345 tightly closes the inlet hole of the cartridge 302.
  • a sterile barrier 344 is attached to the end surface of the valve housing 332 to maintain sterility within the connected 5 cylindrical channel 319 and slotted channels 320 of the valve 316 (see Fig. 15) before the device is activated.
  • a connecting part 303 comprises a tube with a first end 330 for connecting with the valve 316 and a second end 343 for connecting with a hypo- dermic needle (not shown). 0 In Fig. 16, the sterile barrier 344 has been removed by the user as preparation for the injection, and the connecting part 303 has been moved a first distance as part of the triggering of the device, which has abutted the surface 341 (see Fig. 14) of the con necting part 303 against the surface 342 (see Fig.
  • valve body 340 of the valve body 340.
  • the first end 330 of the tube in the connecting part 303 has been moved into the valve5 body 340 and a tightening recess 334 (see Fig. 14) ensures that fluid from the car tridge 302 can only leave the valve 316 through the opening into the first end 330 of the tube.
  • the connecting part 303 has been further moved a second distance due to0 the continued device activation procedure.
  • This has moved the valve 316 within the valve housing 332 and the valve head 345 has been pushed into the cylindrical cavity inside the cartridge 302.
  • the valve 316 is now open so that the fluid from the car tridge 302 can pass through the slotted channels 320 and the cylindrical channel 319 into the opening of the first end 330 of the tube in the connecting part 303.
  • the small flange 321 on the valve body 340 ensures a tight connection to the cylindrical opening of the valve housing 332 so that fluid cannot leave the cartridge 302 on the outside of the valve body 340.
  • Fig. 18 the injection has been fulfilled and the surface 325 of the plunger 324 in the 0 cartridge 302 has abutted the surface 322 of the valve head 345 and pushed the valve 316 and the connecting part 303 a third distance in the opposite direction, the third distance preferably being shorter than the second distance to distinguish the two stag- es of operation.
  • the slotted channels 320 stay open for the content of the cartridge 302 during and after the movement of the third distance.
  • the valve head 345 can be made of the same material as the plunger 324 so that the medicament in the cartridge 302 will only be exposed to well-known and proven ma- terials such as glass and rubber, whereby stability of the medicament/device combina- tion is ensured.

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

Abstract

L'invention concerne une valve (116, 216) pour un dispositif d'injection (100), laquelle valve étant disposée pour fournir une communication fluidique entre un récipient rempli de médicament (102, 202) et un système de distribution de médicament (101) pour distribuer un médicament à un site d'injection pendant l'utilisation du dispositif, la valve ayant une forme sensiblement cylindrique et étant disposée de façon à être au moins partiellement positionnée dans une partie de sortie (123, 223) du récipient de telle sorte que, dans une configuration initiale, la valve ferme la partie de sortie de manière étanche, la valve étant disposée de façon à être déplacée à travers une première distance dans une première direction partiellement dans le récipient, une communication fluidique étant établie à travers la partie de sortie du récipient, et la valve étant en outre disposée de façon à être déplacée à travers une seconde distance dans une seconde direction opposée à la première direction. L'invention concerne en outre un dispositif d'injection (100) comprenant une telle valve (116, 126).
PCT/DK2019/050034 2018-01-30 2019-01-28 Valve pour dispositif d'injection, et dispositif d'injection avec une telle valve WO2019149328A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP19703006.7A EP3746174A1 (fr) 2018-01-30 2019-01-28 Valve pour dispositif d'injection, et dispositif d'injection avec une telle valve
US16/964,306 US20200360235A1 (en) 2018-01-30 2019-01-28 A valve for an injection device and an injection device with such a valve

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DKPA201800049 2018-01-30
DKPA201800049 2018-01-30
DKPA201870111A DK179818B1 (en) 2018-01-30 2018-02-21 VALVE FOR AN INJECTION AND INJECTION WITH SUCH VALVE
DKPA201870111 2018-02-21

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Cited By (1)

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WO2021071740A1 (fr) * 2019-10-08 2021-04-15 Amgen Inc. Mécanisme d'insertion d'aiguille pour dispositif d'administration de médicament

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WO2010022870A1 (fr) * 2008-08-30 2010-03-04 Sanofi-Aventis Deutschland Gmbh Cartouche et système d'aiguille associé
US20120211946A1 (en) * 2011-02-22 2012-08-23 Medtronic Minimed, Inc. Sealing element for a hollow needle of a fluid infusion device
WO2014076282A1 (fr) * 2012-11-16 2014-05-22 New Injection Systems Ltd Ensemble seringue préremplie portable
WO2014080020A1 (fr) * 2012-11-23 2014-05-30 New Injection Systems Ltd Système d'auto-injecteur
WO2017129191A1 (fr) 2016-01-28 2017-08-03 Subcuject Aps Dispositif d'injection portable

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WO2010022870A1 (fr) * 2008-08-30 2010-03-04 Sanofi-Aventis Deutschland Gmbh Cartouche et système d'aiguille associé
US20120211946A1 (en) * 2011-02-22 2012-08-23 Medtronic Minimed, Inc. Sealing element for a hollow needle of a fluid infusion device
WO2014076282A1 (fr) * 2012-11-16 2014-05-22 New Injection Systems Ltd Ensemble seringue préremplie portable
WO2014080020A1 (fr) * 2012-11-23 2014-05-30 New Injection Systems Ltd Système d'auto-injecteur
WO2017129191A1 (fr) 2016-01-28 2017-08-03 Subcuject Aps Dispositif d'injection portable

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021071740A1 (fr) * 2019-10-08 2021-04-15 Amgen Inc. Mécanisme d'insertion d'aiguille pour dispositif d'administration de médicament

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