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WO2022175249A1 - Ensemble aiguille doté d'un élément d'étanchéité - Google Patents

Ensemble aiguille doté d'un élément d'étanchéité Download PDF

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Publication number
WO2022175249A1
WO2022175249A1 PCT/EP2022/053643 EP2022053643W WO2022175249A1 WO 2022175249 A1 WO2022175249 A1 WO 2022175249A1 EP 2022053643 W EP2022053643 W EP 2022053643W WO 2022175249 A1 WO2022175249 A1 WO 2022175249A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
hub
distal
outlet end
seal
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2022/053643
Other languages
English (en)
Inventor
Thibaud HOFSTÄTTER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novo Nordisk AS
Original Assignee
Novo Nordisk AS
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 Novo Nordisk AS filed Critical Novo Nordisk AS
Publication of WO2022175249A1 publication Critical patent/WO2022175249A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • 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
    • A61M5/001—Apparatus specially adapted for cleaning or sterilising syringes or needles
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3293—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle hub
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M2005/3206—Needle or needle hub disconnecting devices forming part of or being attached to the hub or syringe body
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3254—Shielding of proximal needles, e.g. for pen needles

Definitions

  • the present invention generally relates to drug delivery devices intended for subcutaneous injection of a fluid drug formulation.
  • the invention relates to a needle as sembly adapted for mounting on a subcutaneous drug delivery device comprising or being adapted to receive a drug-filled cartridge.
  • Injection drug delivery devices have greatly improved the lives of patients who must self-ad- minister drugs and biological agents. Such devices may take many forms, including simple disposable devices that are little more than an ampoule with an injection means or they may be highly sophisticated instruments with numerous functions. Regardless of their form, they have proven to be great aids in assisting patients to self-administer injectable drugs and bio logical agents. They also greatly assist care givers in administering injectable medicines to those who are incapable of performing self-injections.
  • pen-style injection devices have proven to be an accurate, convenient, and often discrete, way to administer drugs and biological agents, such as insulins.
  • Modern devices have become more sophisticated and may include additional functionalities such as memories for remembering time and amount of last dose.
  • injection devices use a pre-filled cartridge containing the medication of interest.
  • the injection device as such may be of the disposable type in which the cartridge is formed inte grally with the device and is thus not intended for replacement.
  • the injection de vice is of the durable type adapted to receive a cartridge which then can be replaced by the user when desired.
  • a cartridge could be provided with an integrated needle, e.g. as disclosed in US 4,474,734, DE 8906101 U1 or EP 2 548 597, in most cases the cartridge comprises a needle penetratable septum member adapted to be pierced by a hollow needle when a replaceable single-use needle assembly is mounted on the injection device.
  • the injection device and the needle assembly comprise corresponding coupling means allowing the needle assembly to be mounted and replaced after use.
  • the injection device coupling means may be formed integrally with the injection device per se, e.g. as part of the cartridge holder in which the cartridge is arranged, or as part of a cartridge unit as known from e.g. US 6,126,646 and typically used in combination with a durable type injection device.
  • the coupling means may be in the form of a traditional threaded connection in which the needle assembly is screwed onto the injection device or alternatively a bayonet type coupling allowing for faster and easier mounting.
  • a needle assembly basically comprises a hub member having a proximally extending skirt portion with the coupling means, and a hollow needle mounted in the hub member and com prising a distal outlet end adapted to be inserted subcutaneously in a subject and a proximal inlet end adapted to penetrate the septum member when the needle assembly is mounted.
  • the needle assembly further comprises an inner cap member, as disclosed in US 2012/0029440, having a closed distal end and a proximally extending skirt portion allowing the inner cap member to be releasably mounted on the hub member to thereby cover the needle distal outlet end during handling of the needle assembly, an outer cap member having a closed distal end and a proximally extending skirt portion with a circumferential edge, the skirt portion comprising coupling means allowing the outer cap member to be releasably mounted on the hub member, as well as an outer gas-penetratable barrier member attached to the outer cap circumferential edge to create a sealed interior space, the latter allowing sterilization of the entire content of the interior space including the interior lumen of the hollow needle.
  • the needle distal end may be covered by a sealing membrane as disclosed in US 2017/0326305.
  • the recommended way of use of a needle assembly of the above-described type is to mount it on the injection device just prior to the injection event and to subsequently remove and dis card it just after use.
  • a user may decide to leave a used needle assembly on the injection device after use for subsequent removal at a more appropriate time and/or more appropriate place. In the latter case there may also be the risk at that a user un-intentionally (or intentionally) uses the needle again for a subsequent injection.
  • a needle assem bly of the single-use type adapted to be mounted on a subcutaneous injection device which mitigates the undesired consequences of mounting early or leaving on a subcutaneous needle assembly on an injection device.
  • the needle assembly should be easy to use and cost-effec tive to manufacture.
  • a needle assembly comprising a hub mem ber having a central portion and a proximally extending skirt portion, the skirt portion comprising first coupling means allowing the needle assembly to be releasably mounted relative to a drug reservoir having a needle-penetratable septum member, and a hollow needle fixedly mounted in the hub member central portion and comprising a distal outlet end adapted to be inserted subcutaneously in a subject and a proximal inlet end adapted to penetrate the septum member when the needle assembly is mounted relative to the drug reservoir, the hollow needle defining an axis of reference upon which distal and proximal directions can be defined.
  • the needle assembly further comprises an inner cap member having a closed distal end and a proximally extending skirt portion, the skirt portion comprising second coupling means allowing the inner cap member to be releasably mounted on the hub member to thereby cover the needle distal outlet end, and an inner seal member arranged in the distal end of the inner cap member and adapted to receive the needle distal end in sealing engagement to thereby seal the needle distal outlet end.
  • the needle assembly further comprises an outer cap member having a closed distal end and a proximally extending skirt portion with a circumferential edge, as well as an outer gas-penetratable seal member attached to the outer cap circumferential edge to create a sealed interior space.
  • the outer cap skirt portion may comprise coupling means allowing the outer cap member to be releasably mounted relative to the hub member.
  • the needle assembly is actuatable between (i) a first configuration in which the needle distal outlet end is arranged with a distance to the seal member, this allowing gas to flow through the interior of the hollow needle during gas sterilization, and (ii) a second configuration in which the needle distal outlet end is received in sealing engagement in the seal member to thereby seal the needle distal outlet end.
  • the gas may be in the form of e.g. steam.
  • the seal member may be formed from an elastomeric material, e.g. in solid or foam form, allowing the penetrating distal needle outlet end to cut into the material with the remaining portion of the needle distal end entering the seal member in sealing engagement, i.e. contact, between the needle body and the elastomeric material.
  • the hub central portion can be moved axially relative to the hub skirt portion between an initial proximal position and an actuated distal position.
  • the initial proximal position corresponds to the first configuration
  • the actuated distal position corresponds to the second configuration.
  • the hub central portion may be adapted to be moved axially between the initial proximal position and the actuated distal position when the hub member is mounted on a drug reservoir.
  • the hub central portion is connected to the hub skirt portion by integrally formed flexible portions, this allowing the needle to be moved between the initial proximal position and the actuated distal position.
  • the hub central portion is formed by a hub central member in which the hollow needle is fixedly mounted, the skirt portion is formed by a hub skirt member, and the hub central member is moveable relative to the hub skirt member from a proximal position corresponding to the first configuration, to a distal position corresponding to the sec ond configuration.
  • the inner cap member within the sealed interior space, is ar ranged in an initial distal position relative to the hub member corresponding to the first config uration.
  • the inner cap member and/or the hub member are arranged to be moved axially rel ative to each other to an actuated state in which the inner cap member is mounted on the hub member corresponding to the second configuration.
  • the inner cap member and/or the hub member may be moved to the actuated state either when arranged inside the sealed interior of the outer cap member, or subsequently to the sealing barrier having been removed, e.g. during mounting of the needle assembly on the drug reservoir.
  • the inner cap member in the initial position may be releasably coupled to the outer cap mem ber.
  • the inner cap member in the initial position may be coupled to the hub mem ber.
  • a needle assembly comprising a hub member having a central portion and a proximally extending skirt portion, and a hollow needle mounted in the hub member central portion and comprising a distal outlet end adapted to be inserted subcutaneously into a subject and a proximal inlet end adapted to penetrate an elas tomeric septum member.
  • the needle assembly further comprises an inner cap member having a proximally extending skirt portion adapted to be releasably mounted on the hub member to thereby cover the needle distal outlet end.
  • a seal member is arranged in the inner cap member and adapted to receive the needle distal end in sealing engagement to thereby seal the needle distal outlet end.
  • the needle assembly is actuatable between a first configuration in which the needle distal outlet end is arranged with a distance to the seal member, and a second configuration in which the needle distal outlet end is received in the seal member in sealing engagement to thereby seal the needle distal outlet end.
  • the hub central portion is connected to the hub skirt portion by integrally formed flexible portions, this allowing the needle to be moved between the initial proximal position and the actuated distal position.
  • the needle may be arranged to move axially relative to the central portion.
  • the needle assembly may further comprise an outer cap member having a closed distal end and a proximally extending skirt portion with a circumferential edge, as well as an outer gas- penetratable seal member attached to the outer cap circumferential edge to create a sealed interior space.
  • the outer cap skirt portion may comprise coupling means allowing the outer cap member to be releasably mounted on the hub member or the inner cap member.
  • a method of providing a needle assembly with a sealed hollow needle distal outlet end comprising the steps of (i) providing a drug delivery device comprising a drug reservoir having a needle penetratable septum member, (ii) providing a needle assembly comprising: a hub member comprising first coupling means allowing the needle assembly to be releasably mounted relative to the drug reservoir, a hollow needle fix edly mounted in the hub member central portion and comprising a distal outlet end adapted to be inserted subcutaneously in a subject and a proximal inlet end adapted to penetrate the septum member when the needle assembly is mounted on the drug reservoir, a cap member having a closed distal end and a proximally extending skirt portion comprising second coupling means allowing the cap member to be releasably mounted on the hub member to thereby cover the needle distal outlet end, and a seal member arranged in the distal end of the cap member and adapted to receive the needle distal end in
  • the hollow needle with the cap member mounted on the hub member can be moved between an initial proximal position in which the needle distal outlet end is arranged with a distance to the seal member, and an actuated distal position in which the needle distal outlet end is received in sealing engagement in the seal member to thereby seal the needle distal outlet end.
  • the method comprises the further step of (iii) mounting the needle assembly relative to the drug reservoir, thereby penetrating the septum member with the needle inlet end, and moving the hollow needle from the initial proximal position to the actuated distal position to thereby seal the needle distal outlet end.
  • the hub member may comprise a proximally extending skirt portion provided with the first coupling means and a central portion being axially moveable relative to the skirt portion, the hollow needle being fixedly mounted in the central portion.
  • the needle assembly provided in the method may correspond to the above-described needle assemblies.
  • a method of providing a needle assembly with a sealed hollow needle distal outlet end comprising the steps of (i) providing a needle assembly comprising a hub member comprising first coupling means allowing the needle as sembly to be releasably mounted relative to a drug reservoir, a hollow needle fixedly mounted in the hub member and comprising a distal outlet end adapted to be inserted subcutaneously in a subject, and a proximal inlet end adapted to penetrate the septum member when the needle assembly is mounted on the drug reservoir, an inner cap member having a closed distal end and a proximally extending skirt portion comprising second coupling means allowing the cap member to be releasably mounted on the hub member to thereby cover the needle distal outlet end, and a seal member arranged in the distal end of the inner cap member and adapted to receive the needle distal outlet end in sealing engagement to thereby seal the needle distal outlet end.
  • the needle assembly further comprises an outer cap member having a closed distal end and a proximally extending skirt portion with a circumferential edge, and an outer gas- penetratable seal member attached to the outer cap circumferential edge to create a sealed interior space, wherein the inner cap member is arranged in an initial proximal position relative to the hub member in which the seal member is arranged with a distance to the needle distal outlet end.
  • the method comprises the further steps of (ii) providing a flow of a sterilizing gas through the outer seal member and through the hollow needle, and (iii) moving the inner cap member to an actuated distal position in which the needle distal outlet end is received in the seal member in sealing engagement to thereby seal the needle distal outlet end.
  • the inner cap member may be moved to the actuated distal position inside the sealed interior space as part of the manufacturing process, e.g. by impact or by the outer cab member having a design allowing it to be axially compressed.
  • the inner cap member may be moved to the actuated distal position during operation of use after the outer gas-penetratable seal member has been removed from the outer cap member.
  • the inner cap mem ber may be moved to the actuated distal position by moving the outer cap member distally relative to the hub member, e.g. after the hub as been mounted on the reservoir.
  • assembly does not imply that the described components necessarily can be as Snapd to provide a unitary or functional assembly during a given assembly procedure but is merely used to describe components grouped together as being functionally more closely re lated.
  • member does not imply that a given member necessarily is of unitary construction but merely that it functionally and in use can be considered a single component, e.g. a given member may comprise two members.
  • needle assembly covers a core assembly comprising a hub member and a hollow needle as well as such an assembly in combination with additional components.
  • additional components may be arranged between the needle assembly and the reservoir perse, e.g. a coupling member adapted to engage the hub member may be attached to the reservoir.
  • the reservoir coupling means is formed by a cartridge holder in which the cartridge reservoir is permanently or removably mounted.
  • drug is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a cannula or hollow needle in a controlled manner, such as a liquid, solution, gel or fine suspension.
  • the drug may have a blood glucose controlling effect, e.g. human insulin and analogues thereof as well as non insulins such as GLP-1 and analogues thereof.
  • fig. 1A shows a pen-formed drug delivery device
  • fig. 1B shows the pen device of fig. 1A with the pen cap removed
  • fig. 2A shows a prior art needle assembly
  • fig. 2B shows a prior art needle assembly with an inner seal member added
  • fig. 3A show a needle assembly in a first configuration
  • fig. 3B shows the needle assembly of fig. 3A in a second mounted configuration
  • fig. 4 shows a hub member comprising flexible arms
  • fig. 5A shows a needle assembly comprising the hub member of fig. 4
  • fig. 5B shows in cross-sectional view a needle assembly mounted on a cartridge
  • figs. 6A and 6B shows a two-component hub member in first and second configurations
  • figs. 7A-7C show a further embodiment of a needle assembly in different states of use.
  • a prefilled drug delivery such a device providing the basis for the exemplary embodiments of the present invention.
  • the pen-formed drug delivery device 10 shown in figs. 1A and 1B may represent a “generic” drug delivery device, the actually shown device is a Flex- Touch® prefilled drug delivery pen as manufactured and sold by Novo Nordisk A/S, Bagsvasrd, Denmark.
  • the pen device 10 comprises a cap part 7 and a main part having a proximal body or drive assembly portion with a housing 1 in which a drug expelling mechanism is arranged or inte grated, and a distal cartridge holder portion in which a drug reservoir in the form of a drug-filled transparent cartridge 13 with a distal needle-penetrable septum 14 is arranged and retained in place by a non-removable cartridge holder attached to the proximal portion, the cartridge holder having openings allowing a portion of the cartridge to be inspected as well as distal coupling means 15 (also termed needle mount) allowing a needle assembly to be releasably mounted.
  • distal coupling means 15 also termed needle mount
  • the coupling means is in the form of a combined thread and bayonet coupling 15 allowing a needle assembly with either a corresponding thread or bayonet coupling to be mounted.
  • the coupling means 15 could comprise only a thread or a bayonet coupling.
  • the cartridge is provided with a piston driven by a piston rod forming part of the expelling mechanism and may for example contain an insulin, GLP-1 or growth hormone formulation.
  • a proximal-most rotatable dose setting member 80 serves to manually set a desired dose of drug shown in display window 2 and which can then be expelled when the button 90 is actuated.
  • the dose setting member 80 has a generally cylindrical outer surface 81 (i.e.
  • the dose setting member may be slightly tapered) which in the shown embod iment is textured by comprising a plurality of axially oriented fine grooves to improve finger grip during dose setting.
  • the window is in the form of an opening in the housing surrounded by a chamfered edge portion 8 and a dose pointer 9, the window allowing a portion of a helically rotatable indicator member 70 (scale drum) to be observed.
  • the expelling mechanism may comprise a spring as in the shown embodiment which is strained during dose setting and then released to drive the piston rod when the release button is actuated.
  • the expelling mechanism may be fully manual in which case the dose member and the actuation button move proximally during dose setting corresponding to the set dose size, and then is moved distally by the user to expel the set dose, e.g. as in a FlexPen® manufactured and sold by Novo Nordisk A/S.
  • fig. 1A shows a drug delivery device of the prefilled type, i.e. it is supplied with a pre mounted cartridge and is to be discarded when the cartridge has been emptied
  • the drug delivery device may be designed to allow a loaded cartridge to be re placed, e.g. in the form of a “rear-loaded” drug delivery device in which the cartridge holder is adapted to be removed from the device main portion, or alternatively in the form of a “front- loaded” device in which a cartridge is inserted through a distal opening in the cartridge holder which is non-removable attached to the main part of the device.
  • needle assembly shown in fig. 2A may represent a “generic” needle assembly
  • the actually shown assembly is a NovoTwist® needle assembly as manufactured and sold by Novo Nordisk A/S, Bagsvasrd, Denmark.
  • a needle assembly 100 comprising a hub member 110, a hollow needle 110, an inner cap member 130, an outer cap member 140 and an outer seal member 150.
  • the hub member 100 comprises a central portion 115 with an axially arranged through-going bore forming a central-most needle tower, and a proximally extending skirt portion 111.
  • the skirt portion comprises inner coupling means allowing the needle assembly to be releasably mounted on a drug reservoir provided with corresponding coupling means.
  • the hub coupling means is in the form of four protrusions 112 adapted to engage corresponding grooves, e.g. on a cartridge holder distal end as shown in fig. 1 B.
  • the skirt portion comprises first outer coupling means allowing the inner cap member 130 to be releas ably mounted on the hub member, e.g. in the form of circumferential ridge portions 213 (see fig.
  • the skirt portion further comprises second outer coupling means allowing the outer cap member 140 to be releasably mounted on the hub member, e.g. in the form of circumferential groove portions 214 (see fig. 4) adapted to cooperate with a corresponding ridge or lip structure on the outer cap member.
  • the hollow needle 110 is fixedly mounted in the bore of the hub member central portion 115 and held in place by an amount of glue 125.
  • the hollow needle comprises a bevelled distal outlet end 121 adapted to be inserted subcutaneously in a subject and a bevelled proximal inlet end 122 adapted to penetrate a cartridge septum member (e.g. as shown in fig. 1 B) when the needle assembly is mounted on the drug reservoir.
  • both ends of the hollow needle are open and in flow communication with the surrounding space, this allowing gas to flow through the interior of the hollow needle during gas sterilization.
  • the inner cap member 120 comprises a closed distal end 121 and a proximally extending skirt portion 122 with a circumferential edge, the skirt portion comprising coupling means allowing the inner cap member to be releasably mounted on the hub member to thereby cover the needle distal outlet end, e.g. in the form of a circumferential inner lip adapted to engage the ridge portions on the hub member.
  • the outer cap member 140 comprises a closed distal end 141 and a proximally extending skirt portion 142 with a circumferential edge 143, the skirt portion comprising inner coupling means allowing the outer cap member to be releasably mounted on the hub member, e.g. in the form of a circumferential ridge or lip structure adapted to cooperate with the groove portions on the hub member.
  • the outer seal member 150 is in the form of a gas-penetratable sheet member attached to the outer cap circumferential edge 143 to create a sealed interior space.
  • the sheet member is manufactured from a material allowing gas to pass yet prevents germs to enter the sealed interior and comprises a protruding tab portion 151 allowing it to be pulled off by a user prior to mounting the needle assembly.
  • fig. 2B shows a modified version 101 of the needle assembly of fig. 2A in which an inner seal member 135 formed from an elastomeric material has been arranged in the distal portion of the inner cap member 130, the inner seal member being adapted to receive the needle distal end in sealing engagement when the inner cap member is mounted on the hub member 110 to thereby seal the needle distal outlet end.
  • an inner seal member 135 formed from an elastomeric material has been arranged in the distal portion of the inner cap member 130, the inner seal member being adapted to receive the needle distal end in sealing engagement when the inner cap member is mounted on the hub member 110 to thereby seal the needle distal outlet end.
  • fig. 3A shows an exemplary embodiment corresponding to an aspect of the present invention. More specifically, fig. 3A shows a needle assembly 200 similar in design to the needle assembly shown in fig. 2A, thus comprising a hub member 210, a hollow needle 220, an inner cap member 230, an outer cap member 240 and an outer seal member 250.
  • an inner seal member 235 formed from an elastomeric material has been arranged in the distal portion of the inner cap member 230, that the hub central portion 215, and thus the needle, is axially moveable relative to the hub skirt portion from a retraced initial proximal position to a distal position, and that the length of the outer cap member has been extended to accommodate the retracted needle proximal end. Otherwise the two needle assemblies are essentially identical.
  • the needle distal end 221 is open thereby allowing gas sterilization of the needle lumen as in the fig. 2 A embodiment.
  • the retracted central hub portion 215 engages the cartridge distal end and is relative to the hub skirt portion moved distally approximately 2 mm together with the needle 220 which is then received in the inner seal member 235 as shown in fig. 3B.
  • the needle assembly is thus actuatable between (i) a first configuration in which the needle distal outlet end is arranged with a distance to the seal member, this al lowing gas to flow through the interior of the hollow needle during e.g. steam autoclaving, and (ii) a second configuration in which the needle distal outlet end is received in the seal member to thereby seal the needle distal outlet end.
  • Fig. 4 shows in perspective view the hub member 210 of the fig. 3A embodiment, the hub member comprising a central portion 215 with a central-most needle tower as well as four integrally formed flexible arms 217, the latter supporting the central portion relative to the skirt portion 211.
  • the hub member 215 comprises first and second outer coupling means 213, 214 adapted to engage the inner respectively the outer cap member.
  • the flexible arms 217 allow the central needle tower with the needle to move distally relative to the skirt portion when it engages the cartridge distal end.
  • the needle tower 216 is supported by a number of circumferentially spaced axially ar ranged rib members 218 each comprising a proximal free edge adapted to engage the car tridge metal cap 16 that surrounds the uncovered part of the cartridge septum 14, the metal cap being better suited to provide a distally directed force to the needle tower than the more flexible septum member, this as shown in fig. 5B and in contrast to fig. 3B in which the needle tower engages the cartridge septum. It is to be noted that in fig. 5B the flexible arms 217 are not shown.
  • Figs. 6A and 6B illustrate an alternative embodiment of the hub member.
  • the hub member 310 is in the form of a hub assem bly comprising a separate central member 315 with needle tower 316 respectively a separate skirt member 311.
  • the hub assembly is transformable from an initial first configuration (see fig. 6A) in which the central member 315 is arranged in a proximal retracted position relative to the skirt member 311 in which the needle distal outlet end (not shown) is arranged with a distance to the seal member (not shown), to a second actuated configuration (see fig.
  • the skirt member 311 comprises stop structures, e.g. inwardly protruding lip portions 318, engaging corresponding stop structures, e.g. an out wardly protruding circumferential lip 319, on the central member corresponding to its intended distal-most position.
  • Guide structures (not shown) between the two members prevent tilting of the central member 315 during its axial movement.
  • Fig. 7A shows a needle assembly 400 similar in design to the needle assembly shown in fig. 2A, thus comprising a hub member 410, a hollow needle 420, an inner cap member 430 with an inner seal member 435, an outer cap member 440 and an outer seal member 450.
  • the inner cap member 430 with the inner seal member 435 can be arranged in an initial distal position relative to the hub member 410 and thus the needle distal end 421 , this corresponding to the first configuration in which the needle distal outlet end is arranged with a distance to the seal member, this allowing gas to flow through the interior of the hollow needle during steam autoclaving.
  • the inner cap mem ber 430 may be held in its distal position inside the outer cap member 440 either by coupling means arranged between the inner and outer cap members or coupling means arranged be tween the inner cab member and the hub member 410. To accommodate the hub member and the inner cab member in their extended first configuration the length of the outer cab member has been extended.
  • the user mounts the needle assembly on the cartridge needle mount 15 as shown in fig. 7B. Thereafter the user moves the outer cap member 440 and thereby also the inner cab member 430 proximally, the latter thereby engaging the hub member 410 in its proximal-most position, this corresponding to the second configuration in which the needle distal outlet end 421 is received in the inner seal member 435 to thereby seal the needle distal outlet end as shown in fig. 7C.
  • the inner cap member is held in position by coupling means arranged between the two cap members, these coupling means disen gages when the user removes the outer cap member.
  • the coupling means should be designed to safely allow the shift in engagement to prevent the inner cab member from being stuck in the outer cab member.
  • the embodiment of figs. 7A-7C requires an additional mounting step to be per formed by the user in addition to the step of mounting the needle assembly on the cartridge needle mount.
  • the inner cab member may be shifted from its first to its second configuration inside the outer cab just after sterilization and thus provided to the user fully assembled with the needle sealed by the inner seal member. This could be achieved by e.g. impact or by the outer cab member having a design allowing it to be axially compressed.

Landscapes

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

Abstract

Ensemble aiguille comprenant un élément moyeu, et une aiguille creuse montée dans l'élément moyeu comprenant une extrémité distale conçue pour être insérée par voie sous-cutanée et une extrémité proximale conçue pour pénétrer dans un septum élastomère de réservoir. L'ensemble aiguille comprend en outre un élément capuchon conçu pour être monté de manière amovible sur l'élément moyeu pour ainsi recouvrir l'extrémité de sortie distale de l'aiguille. Un élément d'étanchéité est disposé dans l'élément capuchon et est conçu pour recevoir de manière étanche l'extrémité distale de l'aiguille pour ainsi sceller l'extrémité distale de l'aiguille. L'ensemble aiguille peut être actionné entre une première configuration dans laquelle l'extrémité distale de l'aiguille est agencée avec un écartement par rapport à l'élément d'étanchéité, ce qui permet au gaz de s'écouler à travers l'intérieur de l'aiguille creuse pendant la stérilisation au gaz, et une seconde configuration dans laquelle l'extrémité distale de l'aiguille est reçue de manière étanche dans l'élément d'étanchéité pour ainsi sceller l'extrémité distale de l'aiguille.
PCT/EP2022/053643 2021-02-16 2022-02-15 Ensemble aiguille doté d'un élément d'étanchéité Ceased WO2022175249A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP21157330.8 2021-02-16
EP21157330 2021-02-16

Publications (1)

Publication Number Publication Date
WO2022175249A1 true WO2022175249A1 (fr) 2022-08-25

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Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4474734A (en) 1983-07-05 1984-10-02 Microbiological Applications, Inc. Syringe shield and closure sterilization method
DE8906101U1 (de) 1989-05-17 1989-06-29 Arzneimittel Gmbh Apotheker Vetter & Co Ravensburg, 7980 Ravensburg Spritze für medizinische Zwecke
US5858008A (en) * 1997-04-22 1999-01-12 Becton, Dickinson And Company Cannula sealing shield assembly
US6126646A (en) 1990-09-21 2000-10-03 Novo Nordisk A/S Adaptor top
US20120029440A1 (en) 2008-12-23 2012-02-02 Sanofi-Aventis Deutschland Gmbh Apparatus for holding a cover of a needle unit and method
EP2548597A1 (fr) 2010-03-18 2013-01-23 Daikyo Seiko, LTD. Capuchon d'aiguille de seringue
US20130105345A1 (en) * 2010-03-05 2013-05-02 Novo Nordisk A/S Two-Part Hinged Needle Magazine
EP2911724A1 (fr) * 2012-10-25 2015-09-02 Novo Nordisk A/S Dispositif d'injection prérempli à usage unique
US20160008555A1 (en) * 2014-07-11 2016-01-14 Stat Medical Devices, Inc. Pen needle tip and method of making and using the same
US20170326305A1 (en) 2014-12-01 2017-11-16 Novo Nordisk A/S Needle Assembly with Needle Hub Shielding a Needle Cannula
US20180110932A1 (en) * 2015-04-29 2018-04-26 Novo Nordisk A/S Cap Needle Assembly for an Injection Device with Predetermined Breaking Point
US20180117240A1 (en) * 2015-04-28 2018-05-03 Novo Nordisk A/S A Medical Injection Device with Telescopically Movable Needle Shield having a Cleaning Chamber for the Needle
WO2019157176A1 (fr) * 2018-02-12 2019-08-15 Becton, Dickinson And Company Système d'aiguille de stylo
US20200405977A1 (en) * 2019-06-28 2020-12-31 Becton, Dickinson And Company Retractable sleeve for pen needle assembly

Patent Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4474734A (en) 1983-07-05 1984-10-02 Microbiological Applications, Inc. Syringe shield and closure sterilization method
DE8906101U1 (de) 1989-05-17 1989-06-29 Arzneimittel Gmbh Apotheker Vetter & Co Ravensburg, 7980 Ravensburg Spritze für medizinische Zwecke
US6126646A (en) 1990-09-21 2000-10-03 Novo Nordisk A/S Adaptor top
US5858008A (en) * 1997-04-22 1999-01-12 Becton, Dickinson And Company Cannula sealing shield assembly
US20120029440A1 (en) 2008-12-23 2012-02-02 Sanofi-Aventis Deutschland Gmbh Apparatus for holding a cover of a needle unit and method
US20130105345A1 (en) * 2010-03-05 2013-05-02 Novo Nordisk A/S Two-Part Hinged Needle Magazine
EP2548597A1 (fr) 2010-03-18 2013-01-23 Daikyo Seiko, LTD. Capuchon d'aiguille de seringue
EP2911724A1 (fr) * 2012-10-25 2015-09-02 Novo Nordisk A/S Dispositif d'injection prérempli à usage unique
US20160008555A1 (en) * 2014-07-11 2016-01-14 Stat Medical Devices, Inc. Pen needle tip and method of making and using the same
US20170326305A1 (en) 2014-12-01 2017-11-16 Novo Nordisk A/S Needle Assembly with Needle Hub Shielding a Needle Cannula
US20180117240A1 (en) * 2015-04-28 2018-05-03 Novo Nordisk A/S A Medical Injection Device with Telescopically Movable Needle Shield having a Cleaning Chamber for the Needle
US20180110932A1 (en) * 2015-04-29 2018-04-26 Novo Nordisk A/S Cap Needle Assembly for an Injection Device with Predetermined Breaking Point
WO2019157176A1 (fr) * 2018-02-12 2019-08-15 Becton, Dickinson And Company Système d'aiguille de stylo
US20200405977A1 (en) * 2019-06-28 2020-12-31 Becton, Dickinson And Company Retractable sleeve for pen needle assembly

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