WO2018215605A1 - System for safe handling of medical needle unit - Google Patents

System for safe handling of medical needle unit Download PDF

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Publication number
WO2018215605A1
WO2018215605A1 PCT/EP2018/063676 EP2018063676W WO2018215605A1 WO 2018215605 A1 WO2018215605 A1 WO 2018215605A1 EP 2018063676 W EP2018063676 W EP 2018063676W WO 2018215605 A1 WO2018215605 A1 WO 2018215605A1
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WO
WIPO (PCT)
Prior art keywords
needle
shield
housing
pack
relative
Prior art date
Application number
PCT/EP2018/063676
Other languages
French (fr)
Inventor
Søren IVERSEN
Ronan Carroll
Original Assignee
Novo Nordisk A/S
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 to EP17172790 priority Critical
Priority to EP17172790.2 priority
Application filed by Novo Nordisk A/S filed Critical Novo Nordisk A/S
Publication of WO2018215605A1 publication Critical patent/WO2018215605A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • 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
    • A61M5/32Needles; 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
    • A61M5/3202Devices for protection of the needle before use, e.g. caps
    • 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
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245Constructional features thereof, e.g. to improve manipulation or functioning
    • 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
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • 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
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3271Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
    • 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
    • A61M5/32Needles; 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
    • A61M5/34Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • 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
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • 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
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3254Shielding of proximal needles, e.g. for pen needles
    • 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
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/27General characteristics of the apparatus preventing use
    • A61M2205/273General characteristics of the apparatus preventing use preventing reuse, e.g. of disposables

Abstract

The invention provides a needle system (1, 101) comprising a needle unit (10) and a needle pack (60, 160), where the needle pack (60, 160) is used to attach and detach the needle unit (10) to/from a drug delivery device.

Description

SYSTEM FOR SAFE HANDLING OF MEDICAL NEEDLE UNIT

FIELD OF THE INVENTION

The present invention relates to needle units for use with drug delivery devices.

BACKGROUND OF THE INVENTION Drug delivery devices providing for dose setting and administration of a drug substance from a prefilled cartridge are becoming increasingly popular due to an easier-to-handle interface compared to traditional needle-and-syringe solutions which often require manual filling of the syringe prior to a dose administration by transfer of the substance from a separate container.

Such cartridge based drug delivery devices are widely used in the diabetes care segment along with dedicated needle units which are easily attachable thereto and which comprise a front needle part configured for relatively painless entry through a skin barrier and a back needle part configured for penetration of a self-sealing cartridge septum.

A needle unit is typically supplied in a protective storage pack which may be used to safely attach the needle unit to the drug delivery device and which is afterwards discarded. Follow- ing a drug administration the user discards the needle unit itself in a dedicated sharps container. This involves removing the needle unit from the drug delivery device and bringing it to the sharps container.

Even though the needle parts are both short and thin they still pose a risk to the person handling the needle unit, as well as to other people in potential close contact therewith, such as e.g. waste collectors, who may accidentally prick themselves on one of the needle tips.

WO 01/91837 (Novo Nordisk A/S) discloses a needle unit with a safety shield which at retraction of the front needle from the skin following a completed injection is shifted automatically to a position where it covers the front needle, in which position it is irreversibly locked. This provides a shielding of the front needle after its use which prevents subsequent contact with the front needle tip. However, when the needle unit is removed from the injection device the back needle becomes exposed to the surroundings and care should be taken to avoid hazardous encounters with the back needle tip. WO 02/09797 (Becton Dickinson and Company) discloses a pen needle and safety shield system of principally the same type where a safety shield is shifted to cover the front needle at retraction of the front needle from the skin to prevent subsequent contact with the front needle tip. The system comprises a protective cap which houses the pen needle and the safety shield before use and which is adapted to receive the used pen needle after removal from the injection device in a manner whereby the exposed back needle becomes safely enclosed. This provides a disposable unit where both the front needle and the back needle are shielded. However, during the removal of the pen needle from the injection device and until the pen needle is correctly positioned in the protective cap the exposed back needle poses a risk to the user.

In view of the above it is desirable to provide a needle system which poses no or only minimal risk of accidental needle stick injuries.

SUMMARY OF THE INVENTION

It is an object of the invention to eliminate or reduce at least one drawback of the prior art, or to provide a useful alternative to prior art solutions.

In particular, it is an object of the invention to provide a needle system for use with a drug delivery device, where the needle tips are covered and not readily accessible to a person at any time during storage, use and disposal of the needle system.

It is another object of the invention to provide a compact such needle system which takes up little space in a waste container.

It is a further object of the invention to provide a needle system which allows fast and easy attachment to and detachment from a drug delivery device.

It is an even further object of the invention to provide a needle system which is prevented from being used more than once. In the disclosure of the present invention, aspects and embodiments will be described which will address one or more of the above objects and/or which will address objects apparent from the following text.

In one aspect the invention provides a needle system according to claim 1 . Such a system allows the potentially dangerous needle unit to be both mounted on and dismounted from the drug delivery device using the needle pack in a very simple operation. The needle pack houses the needle unit in a pre-use orientation during pre-use storage and in a post-use orientation during post-use storage, where the post-use orientation is the same as the pre-use orientation. This is possible due to the needle shield moving during use of the needle unit from the start position to the end position distally of the start position.

In the start position the needle shield may cover the front needle and the transversal needle shield end wall may be positioned at a first axial distance from a tip portion of the front needle, and in the end position the needle shield may cover the front needle and the transversal needle shield end wall may be positioned at a second axial distance from the tip portion of the front needle, which second axial distance is greater than the first axial distance.

The distal repositioning of the needle shield results in a distal displacement of the needle shield engagement portion which enables engagement with the needle pack engagement portion when the needle pack is slid over the needle unit after use. So, when the needle unit is fully immersed in the needle pack, i.e. when the needle housing is at the specific axial position within the cavity, during pre-use storage the axial distance between the needle shield engagement portion and the needle pack engagement portion allows for separation of the needle unit and the needle pack once the needle unit is mounted on the drug delivery device, and when the needle unit is fully immersed in the needle pack during post-use stor- age the engagement between the needle shield engagement portion and the needle pack engagement portion prevents separation of the needle unit from the needle pack.

This solution provides for a compact needle system in the sense that the size of the needle pack need only be a little larger than the size of the needle unit, and the size of the entire assembled needle system, both pre-use and post-use, thus corresponds to the size of the needle pack. It further provides for a completely safe handling of the needle unit before and during attachment to the drug delivery device as well as during use and during and after detachment from the drug delivery device. The fact that the needle pack also functions as a detachment tool eliminates the risk of needle stick injuries from accidental encounters with the back needle(s), e.g. during placement of a used needle unit in a protective container as described in the prior art.

The operation of the needle system is very simple because the needle pack allows for attachment of the needle unit onto the drug delivery device in a purely axial relative motion between the needle pack and the drug delivery device and for detachment of the needle unit from the drug delivery device in an identical purely axial relative motion. In the former part of the operation the needle unit attaches to a receiving portion of the drug delivery device when the needle pack is slid over said receiving portion and slides out of the cavity when the nee- die pack is subsequently retracted from the receiving portion, and in the latter part of the operation the needle unit attaches to the needle pack when the needle pack is slid over the receiving portion and detaches from the receiving portion when the needle pack is subsequently retracted therefrom. The attachment and detachment of the needle unit on/from the drug delivery device can thus be accomplished both swiftly and easily. In an exemplary embodiment of the invention the needle pack engagement portion comprises a transversally deflectable catch structure extending axially from the transversal needle pack end wall into the cavity, and the needle shield engagement portion comprises a rim portion at the opening of the transversal needle shield end wall. The transversally deflectable catch structure, which is configured for unidirectional travel past the rim portion, may e.g. comprise a pair of prongs forming a harpoon-like structure.

In another exemplary embodiment of the invention the needle pack engagement portion comprises a radially inwardly directed protrusion on the needle pack side wall, and the needle shield engagement portion comprises a radially outwardly directed protrusion on the needle shield. The radially inwardly directed protrusion and the radially outwardly directed protrusion are configured for unidirectional travel of the one past the other.

The needle shield may be axially movable relative to the needle housing from the start position to the end position via an intermediate position proximally of the start position. The intermediate position may be an in-use position in which the front needle protrudes through the opening. The needle unit may further comprise a rotatable part carrying an exterior guide track structure, and the needle shield may further comprise two axially and angularly spaced guide track followers arranged on an interior surface of the needle shield side wall and adapted to interact with the exterior guide track structure. The exterior guide track structure and the two axially and angularly spaced guide track followers may be configured to rotate the rotatable part in a predetermined direction from a first angular position relative to the needle housing to a second angular position relative to the needle housing in response to a proximal movement of the needle shield relative to the needle housing from the start position to the inter- mediate position and to rotate the rotatable part further in the predetermined direction from the second angular position relative to the needle housing to a third angular position relative to the needle housing in response to a subsequent distal movement of the needle shield relative to the needle housing from the intermediate position to the end position. This represents one way of enabling the end position of the needle shield to be a position distally of the start position, based on a non-rotating needle shield. The person skilled in the art will realise that this is merely one exemplary way of enabling the distal movement of the needle shield and that other ways are devisable, e.g. involving a rotatable needle shield.

During rotation of the rotatable part from the second angular position relative to the needle housing to the third angular position relative to the needle housing a portion of the exterior guide track structure may become trapped between the two axially and angularly spaced guide track followers. Subsequent axial displacement of the needle shield relative to the needle housing will thereby be limited, or even prevented, rendering a reuse of the needle unit impossible. The needle unit may further comprise a unidirectional ratchet mechanism providing for unidirectional rotation of the rotatable part relative to the needle housing. This will guarantee that the portion of the exterior guide track structure remains trapped between the two axially and angularly spaced guide track followers even if an attempt to reverse the rotation of the rotatable part is made. In another aspect the invention provides a medical needle unit comprising (a) a needle housing extending along an axis, (b) a needle member fixedly connected with the needle housing, the needle member comprising a front needle pointing in a distal direction and a back needle pointing in a proximal direction, and (c) a needle shield comprising a needle shield side wall, a transversal needle shield end wall having an opening therein for passage of at least a portion of the front needle, and a needle shield engagement portion, the needle shield being irreversibly movable relative to the needle housing from a start position in which the transversal needle shield end wall is positioned distally of a distal tip of the front needle via an intermediate position in which the transversal needle shield end wall is positioned proximally of the distal tip of the front needle to an end position distally of the start position.

This provides a needle unit which may be safely and easily attached to and detached from drug delivery device using an appropriate needle pack, e.g. as described in the above. As used herein, the terms "distal" and "proximal" denote positions at or directions along a drug delivery device, or a needle unit, where "distal" refers to the drug outlet end and "proximal" refers to the end opposite the drug outlet end.

In the present specification, reference to a certain aspect or a certain embodiment (e.g. "an aspect", "a first aspect", "one embodiment", "an exemplary embodiment", or the like) signifies that a particular feature, structure, or characteristic described in connection with the respective aspect or embodiment is included in, or inherent of, at least that one aspect or embodiment of the invention, but not necessarily in/of all aspects or embodiments of the invention. It is emphasized, however, that any combination of the various features, structures and/or characteristics described in relation to the invention is encompassed by the invention unless expressly stated herein or clearly contradicted by context.

The use of any and all examples, or exemplary language (e.g., such as, etc.), in the text is intended to merely illuminate the invention and does not pose a limitation on the scope of the same, unless otherwise claimed. Further, no language or wording in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following the invention will be further described with references to the drawings, wherein Fig. 1 is an exploded view a needle unit used in a needle system according to a first exemplary embodiment of the invention,

Fig. 2 is a perspective view of selected elements of the needle unit in an assembled state,

Fig. 3 shows the needle system according to the first exemplary embodiment of the invention before attachment to a drug delivery device, Fig. 4 shows the needle system after attachment to a drug delivery device,

Figs. 5a and 5b show the needle unit in respective pre-use and post-use states, Fig. 6 shows the needle system before removal of the needle unit from the drug delivery device,

Fig. 7 shows the needle system ready for safe discarding,

Figs. 8-1 1 show the movement of selected components of the needle unit during use, Fig. 12 is a perspective view of a needle system according to a second exemplary embodiment of the invention before use, and

Fig. 13 shows the needle system of Fig. 12 after use.

In the figures like structures are mainly identified by like reference numerals.

DESCRIPTION OF EXEMPLARY EMBODIMENTS When in the following relative expressions, such as "upper" and "lower", are used, these refer to the appended figures and not necessarily to an actual situation of use. The shown figures are schematic representations for which reason the configuration of the different structures as well as their relative dimensions are intended to serve illustrative purposes only. Fig. 1 is an exploded view of a needle unit 10 as used in a needle system according to a first embodiment of the invention, showing some components in cross-section. The needle unit 10 according to this particular embodiment comprises four main sub-assemblies and components; a needle housing 20, a needle manifold 30, a rotator 40, and a needle shield 50.

The needle manifold 30 fluidly connects two back needles 31 a, 31 b with a front needle 31 c and comprises a back needle support 32 having two back needle bores 33a, 33b, each providing for passage of one of the back needles 31 a, 31 b, an intermediate piece 34 having two holes 35a, 35b, through each of which one of the back needles 31 a, 31 b extends, and a channel piece 36 with a front needle carrier 37. The front needle carrier 37 extends from a distal surface of the channel piece 36 and has a pair of centrally located diametrically oppo- site protrusions 38 and a distal toothed rim 39. The two back needles 31 a, 31 b are held by the channel piece 36 and extend in a proximal direction therefrom, whereas the front needle 31 c is held by the needle carrier 37 and extends in a distal direction therefrom. Each of the back needles 31 a, 31 b is configured to establish fluid connection to an interior of a sub- stance carrying cartridge (not shown) by penetration of a sealing cartridge closure. The front needle 31 c is configured to penetrate human skin and establish fluid connection to a drug delivery site.

The rotator 40 comprises a tubular body 41 , on an exterior surface of which is formed a number of guide structures 45. At its distal end the rotator 40 is provided with a pawl 43 configured for interaction with the toothed rim 39 in a unidirectional ratchet mechanism. The rotator 40 fits around the front needle carrier 37, whereby the front needle 31 c extends completely through a lumen 42 of the tubular body 41 .

The needle shield 50 comprises an upper part 51 having a proximally extending activator leg 52 for interaction with a triggering mechanism in a drug delivery device with which the needle unit 10 is intended to be used, and a lower part 53 attached to the upper part 51 and having a transversal end wall 54 with a skin interfacing surface 56 adapted for abutment with a skin section around the drug delivery site, an interior surface 57, and a central opening 55 for the front needle 31 c. A pair of opposite short protuberances 58 and a pair of opposite elongated protuberances 59 are respectively arranged on interior surface portions of the upper part 51. These protuberances 58, 59 are configured for interaction with the respective guide structures 45 on the rotator 40 in a manner which provides for a single use needle unit 10, as will be explained in more detail below.

The needle housing 20 has a hollow oval body 21 which surrounds the needle manifold 30, the rotator 40 and a portion of the needle shield 50 and to which the channel piece 36 is affixed. In pre-use and in-use states of the needle unit 10 the needle shield 50 is capable of sliding motion relative to the needle housing 20 along an axis defined by the front needle 31 c between positions defined by the rotator 40, as explained in more detail below. The needle shield 50 is biased distally by a compression spring (not shown) acting between a distally oriented portion of the channel piece 36 and the interior surface 57. Alternatively, a spring may be arranged in the drug delivery device and act, directly or indirectly, on the activator leg 52.

Fig. 2 is a perspective view of the needle housing 20, the needle manifold 30, and the rotator 40 in an assembled state, the needle housing 20 being shown longitudinally sectioned in order to enable inspection of the interaction between the pawl 43 and the toothed rim 39.

Fig. 3 is a longitudinally sectioned perspective view of a needle system 1 according to a first embodiment of the invention, showing the needle unit 10 arranged in a pre-use storage posi- tion within a needle pack 60. The needle system 1 is shown together with a distal end portion of a drug delivery device housing 90 having an oval main wall 91 and a pair of opposite distal protrusions 92. For the sake of clarity the two parallel drug cartridges accommodated by the drug delivery device housing 90 have been omitted from the various views thereof. The needle pack 60 comprises an axially extending oval side wall 61 and a transversal end wall 62, together defining a cavity 67. The transversal end wall 62 has an interior surface 63 from which two transversally deflectable prongs 64 extend. Each prong 64 has a proximal head 65 which provides a catch member. The end opposite the transversal end wall 62 is open and provides an entrance 69 through which the needle unit 10 has been inserted. A collar 66 extends around the entrance 69 and constitutes an interface for adhesive attachment of a barrier foil (not shown). The barrier foil is adhered to the collar during manufacturing of the needle system 1 in order to preserve a sterile internal environment within the needle pack 60. The barrier foil is provided with a tab allowing it to be easily removed from the collar 66 before use of the needle system 1 . The needle housing 20 is provided with a pair of opposite interior recesses 22, which are adapted to receive the distal protrusions 92 on the drug delivery device housing 90, as well as a number of exterior axial ribs 23. The axial ribs 23 have respective distal end faces (not visible) which are adapted to abut an interior ledge 68 in the oval side wall 61 , thereby defining a maximum point of insertion of the needle unit 10 into the cavity 67 which is spaced apart from the transversal end wall 62. As can be seen from Fig. 3 when the needle unit 10 is at the maximum point of insertion the respective heads 35 are axially spaced from the opening 55 allowing for removal of the needle unit 10 from the cavity 67, the front needle 31 c being positioned completely within a needle chamber 80 formed by the needle shield 50.

Fig. 3 also shows the channels 75 fluidly connecting the respective back needles 31 a, 31 b and the front needle 31 c and further indicates how the respective protrusions 38 interact with an interior rim 48 of the tubular body 41 to thereby axially lock the needle manifold 30 and the rotator 40 to one another in a manner which allows the rotator 40 to rotate about the front needle carrier 37.

The needle unit 10 is adapted to be attached to the drug delivery device housing 90 by movement of the needle system 1 in the direction A. In practice, the user will, after removing the barrier foil from the collar 66, grasp the oval side wall 61 and simply perform a converging relative motion between the needle pack 60 and the drug delivery device housing 90. The needle pack 60 thereby serves as a safe attachment tool and the user can notably attach the needle unit 10 to the drug delivery device housing 90 without risking a needle stick injury.

Fig. 4 shows the needle system 1 after attachment of the needle unit 10 to the drug delivery device housing 90, before removal of the needle pack 60. In this state the distal protrusions 92 reside in the respective recesses 22 of the oval body 21 , providing a snap fit between the drug delivery device housing 90 and the needle unit 10 which is capable of maintaining their relative axial position when the needle pack 60 is subsequently slid off by axial movement away from the drug delivery device housing 90. The obtained relative axial position of the drug delivery device housing 90 and the needle unit 10 is one where a portion of each back needle 31 a, 31 b resides in an interior of a substance containing cartridge (not shown) after having penetrated a sealing septum.

In Fig. 5a the needle pack 60 has been removed and the drug delivery device is ready for use. The skin interfacing surface 56 is brought in abutment with the skin at a desired injec- tion site and the oval main wall 91 is subsequently depressed towards the skin surface, whereby the needle shield 50 will slide axially towards the drug delivery device housing 90, allowing the front needle 31 c to protrude through the opening 55 and penetrate the skin.

Fig. 5b shows the needle unit 10 following a drug administration and after removal of the front needle 31 c from the skin. It is noted that the front needle 31 c is once again completely contained within the needle chamber 80. However, the needle shield 50 is now in a projecting position relative to the needle housing 20 in which a greater axial distance between the transversal end wall 54 and the tip of the front needle 31 c exists than in the pre-use state of the needle unit 10, resulting in an expanded needle chamber 81. In this position the needle shield 50 is axially locked with respect to the needle housing 20. The mechanism which governs the change of state of the needle unit experienced from Fig. 5a to Fig. 5b is explained below in connection with the description of Figs. 8-1 1.

Following the drug administration the needle unit 10 is removed safely from the drug delivery device housing 90 using the needle pack 60 in a reverse manner. Fig. 6 illustrates what results from the needle pack 60 being slid onto the needle unit 10 after use thereof. Due to the projecting position of the needle shield 50 each head 65 will be activated by a rim portion of the opening 55 in the transversal end wall 54 before the axial ribs 23 reach the ledge 68. Thereby, the two prongs 64 will be forced to deflect inwardly towards one another as the heads 65 pass through the opening 55 and into the expanded needle chamber 81 . Following passage of the heads 65 through the opening 55 the prongs 64 will return to their original undeflected state. This ensures that when the needle pack 60 is subsequently slid in the opposite direction the heads 65 will engage the interior surface 57 harpoon-style and force the needle unit 10 to move along, ending the snap-fit engagement in the interface between the protrusions 92 and the recesses 22 and separating the needle housing 20 from the drug delivery device housing 90. The needle pack 60 thereby also serves as a safe detachment tool for a used needle unit 10, which the user can employ without risking a needle stick injury- Fig. 7 depicts the needle system 1 after use where the needle unit 10 is accommodated completely in the needle pack 60. Notably, both the front needle 31 c and the back needles 31 a, 31 b are completely shielded by the needle pack 60, and the needle system 1 can thus be safely discarded.

Figs. 8-1 1 illustrate the movement pattern of the rotator 40 and the needle shield 50 during use of the needle unit 10. Each figure provides a perspective, partly longitudinally sectioned view and a corresponding bottom view of the components.

Fig. 8a shows the rotator 40 and the needle shield 50 in a pre-use relative position corresponding to the state of the needle unit 10 shown in Fig. 4. The needle shield 50 is partly sectioned to provide a better view of the interfacing structures. In the shown state of the needle unit 10 the short protuberance 58 rests on a top face stop 46' of the guide structure 45, which thereby provides a limitation for distal motion of the needle shield 50 relative to the needle housing 20. The elongated protuberance 59 has a sloped surface 59', which is positioned just distally of an upward slide 47', and a vertical surface 59" which is adapted to move into sliding abutment with a vertical stop surface 46" bordering the top face stop 46'. Fig. 8b shows the pawl 43 engaging a tooth on the toothed rim 39, preventing clockwise rotation (as seen from the bottom) of the rotator 40 relative to the needle manifold 30.

Fig. 9a shows the rotator 40 and the needle shield 50 in an in-use relative position corresponding to a situation where the user has placed the skin interfacing surface 56 against a skin portion and depressed the drug delivery device housing 90 (not visible) towards the skin portion. Such an action will, due to the engagement between the distal protrusions 92 and the recesses 22, force the needle housing 20 and the needle manifold 30 distally relative to the needle shield 50 against the force of the compression spring. Since the needle manifold 30 and the rotator 40 are axially locked to one another the distal movement of the needle manifold 30 is duplicated by the rotator 40. This means that the top face stop 46' moves away from the short protuberance while the sloped surface 59' starts to slide along the underside of the upward slide 47', forcing the rotator 40 to undergo an angular displacement in addition to the axial displacement.

At some point during the angular displacement of the rotator 40 the vertical surface 59" meets the vertical stop surface 46" and the rotational movement stops. The respective distal ends of the rotator 40 and the front needle carrier 37 are now in abutment with the interior surface 57, and the front needle 31 c extends fully through the opening 55 and into the skin. Hence, a drug administration can subsequently be performed by suitable operation of the drug delivery device. From Fig. 9b it can be seen how the described angular displacement of the rotator 40 has caused the pawl 43 to move counter-clockwise along the periphery of the toothed rim 39 from one tooth to another.

Following the drug administration the user retracts the front needle 31 c from the skin by pull- ing back the drug delivery device housing 90. The compression spring will consequently force the needle shield 50 distally relative to the needle housing 20 and the rotator 40. Figs. 10a and 1 1 a illustrate what happens when the needle shield 50 and the needle manifold 30 undergo relative axial motion during the retraction of the front needle 31 c.

As the compression spring urges the needle shield 50 forward, initially the vertical surface 59" slides along the vertical stop surface 46", while the short protuberance 58 approaches a downward slide 47" of the guide structure 45. Fig. 10a is a view of the needle shield 50 and the rotator 40 just before the short protuberance 58 reaches the downward slide 47", and where the elongated protuberance 59 has passed the vertical stop surface 46". Fig. 10b reveals that during the relative movement between the needle shield 50 and the needle manifold 30 from Fig. 9a to Fig. 10a the rotator 40 does not rotate.

However, during the subsequent part of the axial movement of the needle shield 50 the short protuberance 58 abuts and travels the downward slide 47", which causes the rotator 40 to rotate again. The rotation continues until the short protuberance 58 meets a horizontal stop surface 47"' at the end of the downward slide 47", at which point a horizontal surface 59"' of the elongated protuberance 59 is positioned just distally of an undersurface stop 46"' of the guide structure 45, as seen in Fig. 1 1 a. This represents a post-use relative position of the rotator 40 and the needle shield 50 which corresponds to the state of the needle unit 10 shown in Fig. 5b. Notably, in this post-use relative position the horizontal stop surface 47"' prevents distal movement of the short protuberance 58 while the undersurface stop 46"' prevents proximal movement of the elongated protuberance 59, and the needle shield 50 is consequently axially locked to the rotator 40. Hence, a reuse of the needle unit 10 is thereby not possible.

Fig. 1 1 b shows the position of the pawl 43 along the toothed rim 39 in the post-use relative position of the rotator 40 and the needle shield 50.

Fig. 12 is a longitudinally sectioned perspective view of a needle system 101 according to a second embodiment of the invention. The needle system 101 comprises a needle unit 10 which is identical to the needle unit described in connection with the first embodiment of the invention, and a needle pack 160 which has the same function as the needle pack 60 according to the first embodiment of the invention but which is configured slightly differently.

The needle unit 10 is in the pre-use state where the front needle 31 c is covered by the needle shield 50 and where the tip of the front needle 31 c is close to the opening 55. The nee- die pack 160 comprises an oval side wall 161 and a transversal end wall 162, together defining a cavity 167. The oval side wall 161 has a pair of opposite distal indentations 164, providing respective interior ridges 165 that in the pre-use state of the needle unit 10 are positioned distally of a peripheral rigid lip 53' at the distal end of the lower part 53. Thereby, the needle pack 160 can be axially slid off following attachment of the needle unit 10 to a drug delivery device housing, similarly to what is described above with respect to the first embodiment of the invention.

Fig. 13 shows the needle unit 10 in a post-use state after re-attachment of the needle pack 160 and removal from the drug delivery device. Due to the needle shield 50 being in the projecting position when the oval side wall 161 slides along the oval body 21 the rigid lip 53' will reach the interior ridges 165 before the axial ribs 23 reach the ledge 68, and on continued proximal motion of the needle pack 160 the rigid lip 53' will deflect the interior ridges 165 transversally and move to a position distally thereof, effectively preventing reverse motion of the needle shield 50 beyond that point. The needle unit 10 is thereby non-releasably anchored within the needle pack 160, and the needle system 101 can be safely discarded as a unified entity.

Claims

1. A needle system (1 , 101 ) for use with a drug delivery device, the needle system (1 , 101 ) comprising:
- a needle unit (10) comprising
o a needle housing (20) extending along an axis,
o a needle member (30) arranged in the needle housing (20), the needle member (30) carrying a front needle (31 c) pointing in a distal direction and at least one back needle (31 a, 31 b) pointing in a proximal direction, and o a needle shield (50) comprising a needle shield side wall, a transversal needle shield end wall (54) having an opening (55) therein for passage of at least a portion of the front needle (31 c), and a needle shield engagement portion (57, 53'), the needle shield (50) being axially and irreversibly movable relative to the needle housing (20) from a start position to an end position distally of the start position, and
- a needle pack (60, 160) comprising a needle pack side wall (61 , 161 ), a transversal needle pack end wall (62, 162), together defining a cavity (67, 167) configured to accommodate the needle unit (10), and a needle pack engagement portion (64, 65; 164, 165),
wherein
- the needle housing (20) is arranged in, or movable relative to the needle pack side wall (61 , 161 ) to, a specific axial position within the cavity (67, 167),
- when the needle housing (20) is at the specific axial position within the cavity (67, 167) and the needle shield (50) is in the start position the needle shield engagement portion (57, 53') and the needle pack engagement portion (64, 65; 164, 165) are axially spaced apart, enabling proximal movement of the needle unit (10) relative to the needle pack side wall (61 , 161 ), and
- when the needle housing (20) is at the specific axial position within the cavity (67, 167) and the needle shield (50) is in the end position the needle shield engagement portion (57, 53') and the needle pack engagement portion (64, 65; 164, 165) are engaged to prevent proximal movement of the needle unit (10) relative to the needle pack side wall (61 , 161 ).
2. A needle system according to claim 1 , wherein the needle pack engagement portion (64, 65) comprises a transversally deflectable catch structure extending axially from the transversal needle pack end wall (62) into the cavity (67), and the needle shield engagement portion (57) comprises a rim portion at the opening (55) of the transversal needle shield end wall (54), and
wherein the transversally deflectable catch structure is configured for unidirectional travel past the rim portion.
3. A needle system according to claim 2, wherein the transversally deflectable catch structure comprises a pair of prongs forming a harpoon like structure.
4. A needle system according to claim 1 , wherein the needle pack engagement portion (164, 165) comprises a radially inwardly directed protrusion on the needle pack side wall (61 ), and the needle shield engagement portion (53') comprises a radially outwardly directed protrusion on the needle shield (50), and
wherein the radially inwardly directed protrusion and the radially outwardly directed protru- sion are configured for unidirectional travel of the one past the other.
5. A needle system according to any of the preceding claims, wherein the needle shield (50) is axially movable relative to the needle housing (20) from the start position to the end position via an intermediate position proximally of the start position,
wherein the front needle (31 c) is covered by the needle shield (50) when the needle shield (50) is in the start position and in the end position, and
wherein the front needle (31 c) protrudes through the opening (55) when the needle shield (50) is in the intermediate position.
6. A needle system according to claim 5, wherein the needle unit (10) further comprises a rotatable part (40) carrying an exterior guide track structure (45), and
wherein the needle shield (50) further comprises two axially and angularly spaced guide track followers (58, 59) arranged on an interior surface of the needle shield side wall and adapted to interact with the exterior guide track structure (45), the exterior guide track structure (45) and the two axially and angularly spaced guide track followers (58, 59) being configured to rotate the rotatable part (40) in a predetermined direction from a first angular posi- tion relative to the needle housing (20) to a second angular position relative to the needle housing (20) in response to a proximal movement of the needle shield (50) relative to the needle housing (20) from the start position to the intermediate position and to rotate the rotatable part (40) further in the predetermined direction from the second angular position relative to the needle housing (20) to a third angular position relative to the needle housing (20) in response to a subsequent distal movement of the needle shield (50) relative to the needle housing (20) from the intermediate position to the end position.
7. A needle system according to claim 6, wherein during rotation of the rotatable part (40) from the second angular position relative to the needle housing (20) to the third angular position relative to the needle housing (20) a portion of the exterior guide track structure (45) becomes trapped between the two axially and angularly spaced guide track followers (58, 59), thereby limiting axial displacement of the needle shield (50) relative to the needle housing (20).
8. A needle system according to claim 7, wherein the needle unit (10) further comprises a unidirectional ratchet mechanism (39, 43) providing for unidirectional rotation of the rotatable part (40) relative to the needle housing (20).
PCT/EP2018/063676 2017-05-24 2018-05-24 System for safe handling of medical needle unit WO2018215605A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP17172790 2017-05-24
EP17172790.2 2017-05-24

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001091837A1 (en) 2000-05-31 2001-12-06 Novo Nordisk A/S A disposable double pointed injection needle, and an insulin injection system comprising a disposable double pointed injection needle
WO2002009797A1 (en) 2000-08-02 2002-02-07 Becton Dickinson And Company Pen needle and safety shield system
US20080177237A1 (en) * 2007-01-23 2008-07-24 Becton Dickinson And Company Safety pen needle with passive safety shield system
US20110257603A1 (en) * 2008-03-13 2011-10-20 Becton, Dickinson And Company Safety pen needle assembly having shielding for patient and non-patient ends
US20140236095A1 (en) * 2011-10-06 2014-08-21 Sanofi-Aventis Deutschland Gmbh Needle Safety Device
US20140288504A1 (en) * 2009-06-18 2014-09-25 Shl Group Ab Safety Pen Needle Device
US20150157807A1 (en) * 2013-12-10 2015-06-11 Becton, Dickinson And Company Active safety pen needle assembly

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001091837A1 (en) 2000-05-31 2001-12-06 Novo Nordisk A/S A disposable double pointed injection needle, and an insulin injection system comprising a disposable double pointed injection needle
WO2002009797A1 (en) 2000-08-02 2002-02-07 Becton Dickinson And Company Pen needle and safety shield system
US20080177237A1 (en) * 2007-01-23 2008-07-24 Becton Dickinson And Company Safety pen needle with passive safety shield system
US20110257603A1 (en) * 2008-03-13 2011-10-20 Becton, Dickinson And Company Safety pen needle assembly having shielding for patient and non-patient ends
US20140288504A1 (en) * 2009-06-18 2014-09-25 Shl Group Ab Safety Pen Needle Device
US20140236095A1 (en) * 2011-10-06 2014-08-21 Sanofi-Aventis Deutschland Gmbh Needle Safety Device
US20150157807A1 (en) * 2013-12-10 2015-06-11 Becton, Dickinson And Company Active safety pen needle assembly

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