WO2009030056A1 - Protective cap for a needle - Google Patents

Protective cap for a needle

Info

Publication number
WO2009030056A1
WO2009030056A1 PCT/CH2008/000362 CH2008000362W WO2009030056A1 WO 2009030056 A1 WO2009030056 A1 WO 2009030056A1 CH 2008000362 W CH2008000362 W CH 2008000362W WO 2009030056 A1 WO2009030056 A1 WO 2009030056A1
Authority
WO
Grant status
Application
Patent type
Prior art keywords
needle
cap
injection
material
reactive
Prior art date
Application number
PCT/CH2008/000362
Other languages
German (de)
French (fr)
Inventor
Benedikt Scheller
Original Assignee
Tecpharma Licensing Ag
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

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
    • A61M5/3202Devices 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
    • A61M5/3146Priming, e.g. purging, reducing backlash or clearance
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M2005/1401Functional features
    • A61M2005/1402Priming
    • 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
    • A61M2005/3125Details specific display means, e.g. to indicate dose setting
    • 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
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583Means for facilitating use, e.g. by people with impaired vision by visual feedback

Abstract

The invention relates to a protective cap for an injection needle, comprising a reactive substance displaying a change in the chemical, physical or physico-chemical state thereof.

Description

Needle cap

The invention relates to a needle protection cap. More particularly, the invention relates to a needle shield for an injection needle with a disposed therein priming indicator, said priming indicator indicates a vented or a non-vented, or ready for use, or a non-application-ready operating state of an injection device. Furthermore, the invention relates to an injection device with such a needle protection cap.

The injection device may be a simple syringe with a reservoir containing a fluid product, or a pen injector with a carpule, which is pre-filled with a fluid product.

The injection apparatus may be detachably connected to a needle support having a fixed welded or bonded injection needle. Alternatively, the injection device may be fixedly connected to a needle carrier, said needle carrier has a fixedly attached hypodermic needle.

From EP 903 157 A2 a packaged needle assembly for an injection device is known which consists of three separate elements, namely an outer needle packaging sleeve, a needle shield and a needle support having therein fixed injection needle. In the initial state, these three members are arranged inside each other, so that the injection needle from the needle cap encloses the needle and cap is surrounded by the needle packaging sleeve. In the use of the needle unit, the needle carrier is applied to an injection device and needle packaging sleeve and the needle shield can be deducted.

WO 2005102419 A1, an injection device for administering a fluid product from a prefilled carpule with priming function is known, preferably in medical, including veterinary, therapeutic, diagnostic, pharmaceutical and / or cosmetic applications. For these applications it is important that a certain fluid product dose is administered. Since the carpule of the injection device is not entirely filled with the fluid product, but contains air or another gas, the air or gas would be administered in conjunction with the fluid product without venting. Consequently, no correct product dosage would be administered and could health complications. To ensure proper dosing, so must the air or gas, which is located in the carpule or accumulated during use, be removed.

May be further impaired by the different level of the carpule the function of the injection device. For this purpose, in the carpule a Karpulenstopfen may be provided, wherein the Karpulenstopfen in the axial feed direction is movable on an outlet of the carpule to displace the fluid product from the carpule. To move the Karpulenstopfen in the advancing direction acts a flange, which is fixedly connected to one end of a piston rod, on the Karpulenstopfen. Between the Karpulenstopfen and the flange of the piston rod some play may be present. is without ensuring that the Karpulenstopfen adjacent to the flange at a product administration, the administered product dosage may be reduced this game accordingly. Consequently also not correct product dosage would be injected. For a correct dosage is guaranteed, a functional check must be carried out, which ensures that the Karpulenstopfen adjacent to the flange of the piston rod before the product administration.

To ensure a correct dosage, especially for venting and for function control of the injection apparatus, therefore, the user is prompted after each Karpulenwechsel and preferably also before each injection for so-called priming. For this purpose, a priming dose, which is preferably smaller than the dose of active ingredient of the product to be injected is set by means of a metering device and distributed by means of a dispenser of the injection device.

To prime the injection device, the user needs some experience and practice. The user pushes his discretion fluid product by the injection needle of the respective injection device until it determines, by visual inspection of the outlet from the fluid product at the needle tip. It is possible that an unnecessary amount of fluid product for the purpose of priming will be distributed, as in priming at its discretion often more than necessary is secreted by the fluid product. Moreover, a visual inspection for users with impaired eyesight is often difficult and causes an increased risk that the priming is not performed correctly. The invention has set itself the object to provide a device which increases the safety due to the ease of use, and that the priming can be performed properly before a targeted drug delivery.

This object is achieved by a needle cap, as defined in the independent patent claim. Advantageous embodiments emerge from the dependent patent claims.

A needle protective cap, such as the invention relates may include a sleeve-shaped base body, which denotes a closed end, hereinafter referred to as a distal end and an open end, referred to as the proximal end, can have. The needle cover may be attached to a needle carrier with a firmly connected hypodermic needle so that the distal end of the needle protection cap surrounding the tip of the injection needle, the inner surface area of ​​the needle protective cap surrounds the shaft of the injection needle and abutting the proximal end of the needle cap to the needle carrier. The needle carrier may be a firmly connected component of a disposable needle assembly, a disposable syringe or a disposable injection apparatus. In addition, in order to be arranged with the injection needle fixedly attached an outer needle package sleeve, the needle cover and the needle carrier. This needle packaging sleeve may also have a sleeve-shaped base body, which denotes a closed end, hereinafter referred to as the distal end, and referred to an open end, referred to as proximal end can have. The distal end of the needle packaging sleeve may surround the distal end of the needle protection cap, the inner surface area of ​​the needle packing sleeve may surround the cladding outer surface of the needle shield and the needle carrier with the fixedly attached hypodermic needle and optionally the syringe or the injection device and the proximal end of the needle packing sleeve by means of a film, closure or a cap-like cover to be sealed sterile.

The inventive needle guard cap has on the inner surface, in particular on the inner surface of the distal end, on the circumferential inner surface of the sleeve-shaped base body and / or on the inner surface of the proximal end of the needle protection cap, a reactive material, which the change of a chemical, physical or physico-chemical state of the substance indicating, for example by a visually detectable change in the reactive aggregate material, by a visually detectable ion exchange reaction between the reactive material and the fluid product or by a visually detectable catalytic reaction, wherein the reactive material may be a catalyst. The reactive material may be directly or indirectly, for example by an adhesive, be connected with the needle protective cap. Alternatively, the reactive substance may be an integral part of the needle protective cap. Advantageously, at least a portion of the interior of the needle cover includes the reactive substance.

In Primingzustand the inventive needle shield can with the needle support having an injection needle firmly connected, enter into a detachable force-locking, form-fitting or other connection. To carry out the priming, a priming dose can be adjusted and be distributed by means of a dispenser of this priming dose injection device by means of a metering device of an injection device. Alternatively, without setting a metering press product according to feeling by the injection needle of the machine, the user, in particular in the use of a syringe. The priming is carried out correctly, if at least one droplet of the fluid product is present at the injection needle tip. This drop can wet the inventive needle cap. Due to the change of state of the reactive material from one state to another state, for example, from a dry to a wet state, the fabric changed so that the user can recognize this change visually. Alternatively, the reactive material may be a change in entropy or enthalpy of the reactive substance visually. Furthermore, the reactive material through an ion exchange reaction between the fluid product and the reactive material may be varied so that this change can be visually recognized, thereby, the reactive material prior to wetting with the fluid product, other anions or cations other than after wetting with the fluid product. In particular, the reactive substance may be an acid-base indicator. a reactive material for the needle cap is preferably used, the color at the respective pH of the distributed product, for example, the pH indicator turns litmus pH <4.5 and red at pH> 8.3 blue. The visual display can be verified that the priming has been carried out correctly.

Advantageously, the needle cap can have a liquid absorbing material so that the priming is sucked while the distributed drops. Absorbing ensures that the consumer or the environment can not come into contact with the distributed fluid product since the distributed drops is absorbed by the absorbent material and can no longer flow out of the needle protective cap.

According to an embodiment of the present invention, the reactive material between the inner surface of the needle protection cap, in particular the inner surface of the distal end, the inner surface area of ​​the sleeve-shaped base body and / or the inner surface of the proximal end of the needle protection cap, and the liquid absorbent material can be arranged, this arrangement is formed so that, for example, first, a threshold value must, before the reactive substance can react with the product distributed by delivery of a recognizable character to be absorbed on the Plasma product by the absorbent material. By this arrangement it can be ensured that the priming is carried out with a minimum dose of fluid product.

According to a further embodiment of the present invention may be a granulate or powder, the liquid absorbing material which is coated with the reactive substance, or the reactive material may be formed from a liquid absorbing material. The substrate coated with the reactive material granules or powder or the reactive substance which is formed of a liquid absorbing material may be attached to the inner surface of the needle protection cap, in particular on the inner surface of the distal end, on the circumferential inner surface of the sleeve-shaped base body and / or on the inner surface the proximal end of the needle shield be provided, or be an integral part of the needle protective cap. Advantageously, at least a part of the interior of the needle cover with the reactive substance coated granules or powder or the reactive substance which is formed of a liquid absorbent material to be filled. The substrate coated with the reactive material granules or powder or the reactive substance which is formed of a liquid absorbing material, may be directly or indirectly, for example by an adhesive, be connected with the needle protective cap. It is advantageous that a chemical, physical or physico-chemical reaction of the reactive substance having a smallest undistributed product dosage can take place under delivery of a recognizable character.

The liquid absorbing material may be a natural or synthetic polymer, in particular cellulose or elastomer, for example polyurethane foam. This liquid absorbing material may enter into a chemical combination with the reactive substance or form a mixture. Furthermore absorbent between the reactive substance or the liquid material and the injection needle can be arranged a water permeable material so that no contamination of the injection needle with the reactive substance or the liquid takes place absorbent material. The water permeable material may be a nonwoven fabric, which is made for example on the basis of a polypropylene-polyethylene blend, or a perforated film, such as a perforated polypropylene, polyester or polyethylene film, to be. The water-permeable material can also be made from cellulosic material.

A preferred embodiment of the invention is explained below with reference to figures.

Show it:

Figure 1: A cross-sectional view of a needle assembly with a needle cap and a packaging sleeve prior to priming.

Figure 2: A cross sectional view of the needle assembly with the needle shield after priming.

1 shows a cross-sectional view of a needle assembly with a needle protective cap 2 and a needle packaging sleeve 1 before the priming. The needle unit comprises a needle support 7, which carries a firmly welded or bonded injection needle. 6 The injection needle 6 is surrounded by the plugged onto the needle carrier 7 needle cap 2 and thus secured, so that the risk of accidental injury is reduced. The needle cover 2 can be slid, snapped or screwed onto the needle carrier. 7 The needle protective cap 2 enters into a releasable connection with the needle carrier. 7 For this purpose, the needle carrier has a circumferential 7 on an outer circumferential surface of the needle carrier 7 ring 7a, projecting in the distal direction and is arranged approximately parallel to the transverse axis of the needle carrier. 7 At the distal end of the ring 7 a bead 7b is provided which protrudes radially inwardly and extends in the circumferential direction of the ring 7a. The bead 7b of needle support 7 holds the needle protective cap 2 by the bead 7b of needle support 7 with a respective corresponding annular groove is locked 2c of the needle cap. 2 The annular groove 2c located on the outer circumferential surface of the needle protection cap 2 and runs approximately parallel to the transverse axis of the needle protective cap 2. In a basic body of the needle protective cap 2 is further at least one circular opening provided 2d, wherein two circular openings 2d are present in this embodiment. The needle packaging sleeve 1 is fitted onto the needle cap 2 or screwed to package the needle assembly with the needle protective cap 2 sterile and to protect from outside forces acting from bumps or before. The proximal end of the packaging sleeve 1 is closed with a foil. 8

The inventive needle guard cap has an inner space which is partly filled with cellulose granules. 3 The filled with cellulose granules interior is limited by the distal end of the needle protection cap and at least through a part of the sleeve-shaped base body and by a part of a nonwoven, in particular of a polypropylene-polyethylene nonwoven fabric. The cellulose granules are aggregated, that an intermediate space is located between the cellulose aggregate and the polypropylene-polyethylene non-woven. 9 The polypropylene-polyethylene nonwoven 5 is disposed to the transverse axis of the needle protective cap 2 and encloses the tip of the injection needle 3 and at least a portion of the shaft of the injection needle 6. The polypropylene-polyethylene nonwoven 5 is shaped so that it is not in contact with the tip and comes to the shaft of the injection needle. 6 For this purpose, the polypropylene-polyethylene nonwoven is displaced 5 with a fixing agent to increase the dimensional stability. Furthermore, the cellulose granules 3 is adapted to absorb liquid. The cellulose granules 3 are coated with a pH-sensitive material 4, in particular with a pH indicator, such as litmus.

2 shows a cross-sectional view of the needle unit is shown with the needle protective cap 2 after priming. To the foil 8 withdrawn from the needle packaging sleeve 1 prior to administering a fluid product, such as insulin having a pH of 4 to prime the injection device is, and the needle carrier 7 having the fixed networks injection needle 6 with the needle protective cap 2 and the needle packaging sleeve 1 mounted on the injection device attached, clipped, snapped or screwed on. On the outer circumferential surface of the needle packaging sleeve 1 are protrusions or grooves which extend radially outwards, are provided which facilitate the mounting of the needle support 7 to the injection device. After securing the needle carrier to the injection device the needle packaging sleeve 1 is pulled away from the needle assembly. As described above, the priming is performed by a priming dose is set by means of a metering device of the injection device and distributed by means of a dispenser of the injection device. The priming dose of insulin is then injected into the needle cap. 2 The insulin passes through the polypropylene-polyethylene nonwoven 5 and is absorbed by the litmus Zelluloseganulaten located in the needle protective cap 2, so that the insulin no longer flows from the needle cap. 2 The air or the gas which is located in the interior of the needle protective cap 2 can escape through the openings 2b, 2d of the base body of the needle protective cap. The acidic insulin goes a Protolysegleichgewichtein with the litmus cellulose granules. The initially colorless insulin takes the color red on the Lackmussäure. The red color indicates that the priming was carried out properly. Thereafter, the red-colored needle protective cap 2 can be withdrawn from the needle support 7 or removed and the product dose can be administered,

Reference numerals:

1 needle packaging sleeve

2 needle cap

2a distal end of the Nadeischutzkappe

2b base body of the needle protection cap

2c groove

2d opening

3 cellulose pellets

4 pH-sensitive material

5 fleece

6 injection needle

7 needle carrier

7a ring

7b bead

8 needle package sleeve foil

9 clearance

Claims

claims
1. needle protective cap (2) for an injection needle (6), characterized in that the needle protection cap (2) a reactive material (4) indicating the change of a chemical, physical or physico-chemical state of the substance (4).
2. needle cover according to claim 1, characterized in that the needle protection cap (2) comprising absorbent material (3) is a liquid.
3. needle protective cap (2) according to claims 1 and 2, characterized in that the reactive material (4) between the inner surface of the needle protective cap (2) and the liquid-absorbent material (3) is arranged.
4. needle protective cap (2) according to claims 1 and 2, characterized in that the liquid absorbing material (3) is a granulate or a powder, and with the reactive substance (4) is coated.
5. needle shield according to claims 1 and 2, characterized in that the reactive material (4) of absorbent from a liquid material (3) is formed.
6. needle protective cap (2) according to claim 1, characterized in that the reactive material (4) indicates a dry-wet change visually.
7. needle protective cap (2) according to claim 6, characterized in that the reactive substance (4) indicating a pH change visually.
8. needle protective cap (2) according to claim 2, characterized in that the liquid absorbing material (3) is a polymer.
9. needle protective cap (2) according to claim 8, characterized in that the liquid absorbing material (3) is cellulose.
10. An injection device with a needle protective cap (2) according to any one of claims 1-9, characterized in that a first condition is indicated, wherein the injection device is in a carpule or an injection needle (6) air and a second state is displayed, wherein in the carpule or the injection needle (6) of the injection device the air is removed.
PCT/CH2008/000362 2007-09-04 2008-09-02 Protective cap for a needle WO2009030056A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CH13732007 2007-09-04
CH1373/07 2007-09-04

Publications (1)

Publication Number Publication Date
WO2009030056A1 true true WO2009030056A1 (en) 2009-03-12

Family

ID=40085485

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CH2008/000362 WO2009030056A1 (en) 2007-09-04 2008-09-02 Protective cap for a needle

Country Status (1)

Country Link
WO (1) WO2009030056A1 (en)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010030602A1 (en) * 2008-09-09 2010-03-18 Baxter International Inc. Device to indicate priming of an infusion line
US8632503B2 (en) 2008-03-13 2014-01-21 Becton, Dickinson And Company Safety pen needle assembly having shielding for patient and non-patient ends
US8801673B2 (en) 2008-03-13 2014-08-12 Becton Dickinson & Company Safety pen needle assembly having shield for non-patient end
US9623194B2 (en) 2013-12-10 2017-04-18 Becton, Dickinson And Company Passive safety pen needle assembly
US9642971B2 (en) 2008-03-13 2017-05-09 Becton, Dickinson And Company Safety needle assembly
US9649452B2 (en) 2013-12-10 2017-05-16 Becton, Dickinson And Company Active safety pen needle assembly

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030187403A1 (en) * 2002-03-30 2003-10-02 Ernest Balestracci Tamper evident overap for a container
US20050283116A1 (en) * 2001-01-12 2005-12-22 Bracco Diagnostics Inc. Tamper evident syringe barrel
US20070287989A1 (en) * 2006-05-08 2007-12-13 Becton, Dickinson & Company Vascular access device pathogenic status indication
US20080021392A1 (en) * 2006-07-20 2008-01-24 Lurvey Kent L Medical fluid access site with antiseptic indicator
EP1547630B1 (en) * 2003-12-23 2008-04-23 JMS North America Corp. Double membrane transducer protector

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050283116A1 (en) * 2001-01-12 2005-12-22 Bracco Diagnostics Inc. Tamper evident syringe barrel
US20030187403A1 (en) * 2002-03-30 2003-10-02 Ernest Balestracci Tamper evident overap for a container
EP1547630B1 (en) * 2003-12-23 2008-04-23 JMS North America Corp. Double membrane transducer protector
US20070287989A1 (en) * 2006-05-08 2007-12-13 Becton, Dickinson & Company Vascular access device pathogenic status indication
US20080021392A1 (en) * 2006-07-20 2008-01-24 Lurvey Kent L Medical fluid access site with antiseptic indicator

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9642971B2 (en) 2008-03-13 2017-05-09 Becton, Dickinson And Company Safety needle assembly
US8632503B2 (en) 2008-03-13 2014-01-21 Becton, Dickinson And Company Safety pen needle assembly having shielding for patient and non-patient ends
US8801673B2 (en) 2008-03-13 2014-08-12 Becton Dickinson & Company Safety pen needle assembly having shield for non-patient end
US9162030B2 (en) 2008-03-13 2015-10-20 Becton, Dickinson And Company Safety pen needle assembly having shielding for patient and non-patient ends
WO2010030602A1 (en) * 2008-09-09 2010-03-18 Baxter International Inc. Device to indicate priming of an infusion line
US8663160B2 (en) 2008-09-09 2014-03-04 Baxter International Inc. Device to indicate priming of an infusion line
US8398590B2 (en) 2008-09-09 2013-03-19 Baxter International Inc. Device to indicate priming of an infusion line
US9623194B2 (en) 2013-12-10 2017-04-18 Becton, Dickinson And Company Passive safety pen needle assembly
US9649452B2 (en) 2013-12-10 2017-05-16 Becton, Dickinson And Company Active safety pen needle assembly

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