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WO2014072499A1 - Dispositif de distribution de médicaments présentant une protection intégrée - Google Patents

Dispositif de distribution de médicaments présentant une protection intégrée Download PDF

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Publication number
WO2014072499A1
WO2014072499A1 PCT/EP2013/073466 EP2013073466W WO2014072499A1 WO 2014072499 A1 WO2014072499 A1 WO 2014072499A1 EP 2013073466 W EP2013073466 W EP 2013073466W WO 2014072499 A1 WO2014072499 A1 WO 2014072499A1
Authority
WO
WIPO (PCT)
Prior art keywords
shield
reservoir
drug
shielding
needle
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/EP2013/073466
Other languages
English (en)
Inventor
Michael MONRAD
Jesper HØHOLT
Bennie Peder Smiszek Pedersen
Carsten Schau ANDERSEN
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 WO2014072499A1 publication Critical patent/WO2014072499A1/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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M2005/314—Flat shaped barrel forms, e.g. credit card shaped
    • 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
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • A61M2005/325—Means obstructing the needle passage at distal end of a needle protection sleeve

Definitions

  • the present invention generally relates to medical delivery devices adapted for transcutaneous delivery of an amount of drug.
  • Drug Injection devices have greatly improved the lives of patients who must self-administer drugs and biological agents.
  • Drug Injection 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 electronically controlled instruments with numerous functions. Regardless of their form, they have proven to be great aids in assisting patients to self- administer injectable drugs and biological agents. They also greatly assist care givers in ad- ministering injectable medicines to those incapable of performing self-injections.
  • pen-style injection devices have proven to provide an accurate, convenient, and often discrete, way to administer drugs and biological agents, such as insulin. Modern devices have become more sophisticated and often include diverse and robust functions, such as memories for remembering time and amount of last dose, as well as, in the case of insulin devices, blood glucose monitors. While pen-style injection devices are typically cylindrically shaped with a needle protruding from the most distal portion of one end of the device, some devices have other shapes with the needle no longer protruding from the most distal part of an end of the device, e.g. Innovo® and InnoLet® from Novo Nordisk A/S, Bagsvaerd, Den- mark.
  • injection devices use a pre-filled cartridge containing the medication of interest, e.g. 1.5 or 3.0 ml of insulin or growth hormone.
  • the cartridge is typically in the form of a generally cylindrical transparent ampoule with a needle pierceable septum at one end and an opposed piston designed to be moved by the dosing mechanism of the injection device.
  • the injection devices generally are of two types: “Durable” devices and “disposable” devices.
  • a durable device is designed to allow a user to replace one cartridge with another cartridge, typically a new cartridge in place of an empty cartridge.
  • a disposable device is provided with an integrated cartridge which cannot be replaced by the user; when the car- tridge is empty the entire device is discarded.
  • injection devices are provided with a re- leasable pen cap covering and protecting the cartridge, the needle mount portion with the pierceable septum, and, as may be the case, a mounted needle. To protect the needle it is normally provided with an inner needle cap.
  • injection devices are provided as a system or family of devices containing different types of drugs, e.g. as known from WO 2004/069314.
  • This application discloses a system of substantially identical injection devices, each individual injection device comprising a housing accommodating an ampoule containing drug sufficient for a number of injections and a dose setting mechanism by which a predetermined dose size can be set, and wherein each of the plurality of injection devices has a different predetermined dose size.
  • the difference in the predetermined dose sizes can in one embodiment be based on the drug in the devices having different strength.
  • People suffering from diabetes are often treated with multiple daily injections in a regimen comprising one or two daily injections of long acting insulin to cover the basal requirement supplemented by bolus injections of short or rapid acting insulin to cover requirements related to meals.
  • a user will therefore often require two different injection devices, one containing the long act- ing insulin and another containing the short or rapid acting insulin. Often these injection devices have different colour indications to inform the user of the kind of insulin contained in the injection device.
  • the FlexPen® system offered by Novo Nordisk comprises pens for long and short acting insulins as well as for mixed insulin, the bodies and caps being identical with colour markings on the main body to differentiate the two types of insulin.
  • the SoloStar® system offered by Sanofi-Aventis the pens for long and short acting insulins have differently coloured bodies as well as caps.
  • these injection devices can be provided with tactile means such as a mechanical coding informing the user of the kind of insulin contained in the injection device.
  • a drug delivery system comprising a drug delivery device with a main part and a shield, the main part comprising a drug reservoir or means for receiving and holding a drug reservoir, the drug reservoir having a distal outlet, and drug expelling means for expelling drug from the reservoir.
  • the shield is moveably mounted to the main part and is displaceable by a user between a shielding and a non- shielding position, the shield comprising an opening, and closure means for closing the opening, the closure means being reversible actuatable between a closed state and an open state.
  • the shield in the shielding position covers the distal outlet of a mounted reservoir or the distal end of the means for receiving and holding a drug reservoir
  • the shield in the non-shielding position with the closure means in the open state, allows the distal outlet of a mounted drug reservoir or the distal end of the means for receiving and holding a drug reservoir to protrude through the opening.
  • the means for receiving and holding a drug reservoir may be in the form of a car- tridge holder.
  • the shield can be used to safely identify the drug content of a given drug delivery device without the risk of a user mounting a given cap on a non-corresponding device main part with the possible risk of taking the wrong medication, e.g. mounting a cap indicating short acting insulin on a main device portion containing long acting insulin.
  • a drug delivery device which is simple and convenient in use is provided, e.g. having no loose parts which can be displaced or lost.
  • the reversible operatable closure means allows that a mounted needle assembly or the reservoir outlet can be well protected against dust and dirt, thereby providing the same functionality as a traditional removable cap.
  • US 5,360,408 and WO 201 1/007178 disclose safety shields which will cover a needle tip after having been actuated, however, in accordance with the purpose of the shields they are adapted to permanently close an opening.
  • the closure means is actuated automatically from the closed to the open state when the shield is moved from the shielding to the non-shielding position, and from the open to the closed state when the shield is moved from the non-shielding to the shielding position.
  • the closure means may be operated manually by a user.
  • the drug delivery device may be provided with a needle mount associated with the distal out- let of a mounted reservoir or the distal end of the means for receiving and holding a drug reservoir, the needle mount being adapted to allow a needle assembly to be mounted in fluid communication with the reservoir, wherein the shield in the shielding position, with the closure means in the closed state, covers the needle mount.
  • the drug delivery system may further comprise a needle assembly comprising a needle hub adapted to be mounted on the main portion needle mount, and a hollow needle mounted in the needle hub and comprising a distal pointed end and a proximal end, the proximal end being adapted to be arranged in fluid communication with the reservoir when the hub is mounted on the main portion needle mount, wherein the shield in the shielding position, with the closure means in the closed state, covers the distal pointed end of a mounted needle assembly.
  • the needle assembly may be provided with a needle cap adapted to be mounted on the needle hub to cover the distal pointed end, wherein the shield in the shielding position, with the closure means in the closed state, covers the needle cap of a mounted needle assembly.
  • the main part may define a general longitudinal axis, the shield being axially slideable relative to the main part between the shielding and non-shielding positions. Further, the shield may be moved between the shielding and non-shielding positions by at least in part a helical movement relative to the main part.
  • the shield may in the shielding position circumferentially fully cover the distal outlet of a mounted reservoir or the distal end of the means for receiving and holding a drug reservoir.
  • the shield may be partially open circumferentially, e.g. for technical design rea- sons, however, such a partially open shield should be designed to prevent user access to the shielded structure to a high degree.
  • the closure means may in the closed position axially fully cover the distal outlet of a mounted reservoir or the distal end of the means for receiving and holding a drug reservoir.
  • the closure means may be partially open axially, e.g. for technical design reasons, however, such a partially open closure means should be designed to prevent user access to the shielded structure to a high degree.
  • the shield may be provided with one or more inspection openings or windows allowing a user to inspect at least a portion of a mounted reservoir or needle assembly. In this way a user does not have to remove the cap to check if a needle assembly is mounted or to check the reservoir.
  • the main portion may be provided with a user-inspectable portion adapted to be covered by the shield, the shield being provided with one or more inspection openings or windows allowing a user to inspect at least a portion of the user-inspectable portion.
  • the user-inspectable portion may comprise a transparent reservoir portion allowing a user to inspect drug contained in the reservoir or the position of a piston located in the reservoir.
  • the shield may be provided with a second set of inspection openings or windows arranged generally opposite the first set, this allowing light to travel through the reservoir.
  • the shield may be generally non-transparent and be provided with one or more transparent windows, the transparent windows comprising means for reducing transmission of light detrimental to drug contained in the reservoir, e.g. a UV filter.
  • the main part of the drug delivery device comprises a reservoir
  • the different embodiments may be adapted to re- ceive a replaceable reservoir, e.g. a cartridge to be used in combination with a durable type injection device.
  • drug is meant to encompass any drug-containing flowable medi- cine 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.
  • Representative drugs include pharmaceuticals such as peptides (e.g. insulins, insulin containing drugs, GLP- 1 containing drugs as well as derivates thereof), proteins, and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substanc- es in both solid (dispensed) or liquid form.
  • peptides e.g. insulins, insulin containing drugs, GLP- 1 containing drugs as well as derivates thereof
  • proteins e.g. insulins, insulin containing drugs, GLP- 1 containing drugs as well as derivates thereof
  • hormones e.g. insulins, insulin containing drugs, GLP- 1 containing drugs as well as derivates thereof
  • hormones e.g. insulins, insulin containing drugs, GLP-
  • fig. 1 shows an embodiment of a drug delivery device with a shield in a shielding position
  • fig. 2 shows the device of fig. 1 with the shield in a non-shielding position
  • fig. 3 shows an exploded view of the device of fig. 1 ,
  • fig. 4 shows a cross-sectional view of the device of fig. 1 ,
  • fig. 5 shows a cross-sectional view of the device of fig. 2 and
  • fig. 6 shows a side view of the device of fig. 1 .
  • the device comprises a main (or body) part 10 on which a retractable but non-removable shield 20 is mounted.
  • the main part defines a general longitudinal axis.
  • the main part comprises (see fig. 3) a drug-filled reservoir (or cartridge) 30 with an axially displaceable piston 31 and a distal outlet 32 with an associated needle mount 35 adapted to allow a needle assembly to be mounted in fluid communication with the reservoir.
  • the needle mount may be part of either the cartridge or the structure for holding the cartridge.
  • the main part further comprises a drug expelling means (not shown) for moving the piston distally to thereby expel a user-settable dose of drug from the reservoir.
  • the mounted needle assembly 40 comprises a needle hub 41 adapted to be mounted on the needle mount, a hollow needle 42 mounted in the needle hub and comprising a distal pointed end and a proximal end, the proximal end being adapted to be arranged in fluid communication with the reservoir when the hub is mounted on the main part needle mount.
  • An inner cap (not shown) may be mounted on the needle hub to cover the distal portion of the needle.
  • the shield is moveably mounted to the main part and is displaceable by a user between a shielding and a non-shielding position, the shield comprising a shield main part 21 with a distal opening 22 sized to allow a mounted needle assembly to move there through, and a closure member 25 for closing the opening.
  • the closure member is reversible actuatable between a closed state and an open state and is associated with an actuation member 26 serving to both actuate the closure member and move the shield main part back and forth between a distal shielding position (see fig. 1 ) and a retracted proximal non-shielding position (see fig. 2).
  • the shield when the shield is in the shielding position it covers the distal pointed end of a mounted needle assembly with the closure member in its closed stat, and when the shield is in the non-shielding position with the closure means in its open state it allows the distal pointed end of a mounted needle assembly to protrude from the opening and thus to be inserted subcu- taneously. In this position it is also possible to remove and mount a needle assembly.
  • the closure means is actuated from the closed to the open state when the shield is moved from the shielding to the non-shielding position, and actuated from the open to the closed state when the shield is moved from the non-shielding to the shielding position.
  • Fig. 3 shows in an exploded view the parts making up the shield 20, i.e. the shield main part 21 with the distal opening 22, the closure member 25 formed as the distal portion of a flexible strip member 24, and the actuation member 26.
  • the drug delivery device main part 10 is shown with a cartridge holder 16 without a mounted cartridge. In the shown embodiment the cartridge holder and a therein mounted cartridge are arranged corresponding to general longitudinal axis of the main part.
  • Figs. 4 and 5 show the drug delivery device 1 of figs. 1 and 2 in cross-sectional views with mainly the features relevant for the present invention shown in detail.
  • the device body portion is shown with a cartridge 30 mounted in a cartridge holder 15 having an opening 16 allowing a portion of the cartridge to be inspected, the piston rod for moving the cartridge piston 31 and the drug expelling means for driving the piston rod not being shown.
  • These parts of the device may be of any suitable design, either manual or motorized.
  • An example of a manual expelling mechanism which would be suitable for use in a drug delivery device having the shown boxy "doser" configuration is disclosed in US 6,796,970 hereby incorporated by reference.
  • a motorized electronically controlled device may be provided with a display 19 providing a user with relevant information, e.g. showing size and time values for a log of expelled amounts of drug.
  • the actuation member 26 is mounted non-releasably in a cut-out in the shield main part and moveable in a guided relationship with the shield main part via the slider portion 27 between a distal and a proximal position.
  • the flexible strip member is mounted non-releasably to the actuation member and moveable in a guided relationship with the shield main part between a distal position in which the distal portion 25 serves as the actual closure member to close the opening 22.
  • the shield is provided with means, e.g. detents, serving to ensure that when the actuation member is moved proximally with the shield in its shielding position and the opening closed, the flexible member is retraced proximally to open the opening be- fore the shield main part is retracted.
  • detents serving to ensure that when the actuation member is moved proximally with the shield in its shielding position and the opening closed, the flexible member is retraced proximally to open the opening be- fore the shield main part is retracted.
  • the shield main portion is moved to the shielding position before the flexible member is moved distally to close the opening.
  • the device main part and the shield main part are provided with corresponding detents 18, 28 serving as locking means to lock and hold the shield in its shielding respectively non-shielding position.
  • the shield may be adapted to be removed from the device main part to allow for (easy) insertion of a new cartridge in the cartridge holder, e.g. by pulling the detent 18 out of engagement with the device main part.
  • the cartridge holder may be adapted to be removed from the main part during cartridge exchange, or it may be actuatable, e.g. by sliding or pivoting movement, between an open cartridge receiving state and a closed state.
  • the shield may be generally non-transparent and be provided with one or more transparent windows 29, the transparent windows comprising means for reducing transmission of light detrimental to drug contained in the reservoir, e.g. a UV filter.
  • a transparent window may also allow a user to easily check whether or not a needle assembly is mounted, see fig. 6.
  • the shield is arranged axially slideable relative to the main part between the shielding and non-shielding positions, such a movement being the most relevant for a drug delivery device having a box-shaped configuration.
  • the shield could be actuated by rotation and moved between the shielding and non-shielding positions by a fully or partly helical movement relative to the main part.
  • the shield may have a generally cylindrical configuration with a distal opening.
  • the closure means arranged to close the opening could be actuated between a closed and open state by an initial pure rotation of the shield relative to the main part, e.g. 15 degrees, after which further rotation of the shield, e.g. 90 degrees, results in the shield being retracted to its non-shielding position by a helical movement.
  • the axial movement could also be a pure axial movement.
  • the closure means could e.g. be of the aperture type or comprise one or more hinged doors being moved outwards when actuated. The latter type of closure means may be actuated by axial movement of the shield.

Landscapes

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

Abstract

L'invention concerne un système de distribution de médicaments comprenant une partie principale (10) équipée d'un réservoir à médicaments (30) doté d'une extrémité distale et une protection (20) montée de manière mobile sur la partie principale, la protection pouvant être déplacée par un utilisateur entre une position de protection et une position de non-protection. La protection présente un moyen d'ouverture (22) et de fermeture (25) pour fermer l'ouverture, le moyen de fermeture étant actionnable de manière réversible entre un état fermé et un état ouvert. Lorsque la protection est en position de protection, le moyen de fermeture étant dans l'état fermé, la protection couvre la sortie distale d'un réservoir monté et lorsque la protection est dans la position de non-protection, le moyen de fermeture étant dans l'état ouvert, alors la sortie distale d'un réservoir à médicaments monté peut faire saillie au travers de l'ouverture.
PCT/EP2013/073466 2012-11-09 2013-11-11 Dispositif de distribution de médicaments présentant une protection intégrée Ceased WO2014072499A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP12192029.2 2012-11-09
EP12192029 2012-11-09
US201261727141P 2012-11-16 2012-11-16
US61/727,141 2012-11-16

Publications (1)

Publication Number Publication Date
WO2014072499A1 true WO2014072499A1 (fr) 2014-05-15

Family

ID=47172515

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2013/073466 Ceased WO2014072499A1 (fr) 2012-11-09 2013-11-11 Dispositif de distribution de médicaments présentant une protection intégrée

Country Status (1)

Country Link
WO (1) WO2014072499A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5360408A (en) 1992-11-16 1994-11-01 Vaillancourt Vincent L Shielded hypodermic needle assembly and a shield assembly for a hypodermic needle
US5651774A (en) * 1996-09-11 1997-07-29 William J. Taranto Hypodermic syringe with safety shield and method of using same
US6004297A (en) 1998-01-30 1999-12-21 Novo Nordisk A/S Injection syringe
WO2004069314A1 (fr) 2003-02-04 2004-08-19 Novo Nordisk A/S Dispositif d'injection comportant un mecanisme de dosage rotatif
US6796970B1 (en) 1997-06-17 2004-09-28 Novo Nordisk A/S Dose setting device
US20050171483A1 (en) * 2004-02-03 2005-08-04 Dennis Williams Needle cover extractor
WO2011007178A2 (fr) 2009-07-16 2011-01-20 Hoelling, Ronald Adaptateur universel

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5360408A (en) 1992-11-16 1994-11-01 Vaillancourt Vincent L Shielded hypodermic needle assembly and a shield assembly for a hypodermic needle
US5651774A (en) * 1996-09-11 1997-07-29 William J. Taranto Hypodermic syringe with safety shield and method of using same
US6796970B1 (en) 1997-06-17 2004-09-28 Novo Nordisk A/S Dose setting device
US6004297A (en) 1998-01-30 1999-12-21 Novo Nordisk A/S Injection syringe
WO2004069314A1 (fr) 2003-02-04 2004-08-19 Novo Nordisk A/S Dispositif d'injection comportant un mecanisme de dosage rotatif
US20050171483A1 (en) * 2004-02-03 2005-08-04 Dennis Williams Needle cover extractor
WO2011007178A2 (fr) 2009-07-16 2011-01-20 Hoelling, Ronald Adaptateur universel

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