WO2008098860A1 - Contenant pour dispositif médical - Google Patents

Contenant pour dispositif médical Download PDF

Info

Publication number
WO2008098860A1
WO2008098860A1 PCT/EP2008/051415 EP2008051415W WO2008098860A1 WO 2008098860 A1 WO2008098860 A1 WO 2008098860A1 EP 2008051415 W EP2008051415 W EP 2008051415W WO 2008098860 A1 WO2008098860 A1 WO 2008098860A1
Authority
WO
WIPO (PCT)
Prior art keywords
plug
container
passage
container according
housing
Prior art date
Application number
PCT/EP2008/051415
Other languages
English (en)
Inventor
Victor Kronestedt
Istvan Bartha
Original Assignee
Shl Medical Ab
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 Shl Medical Ab filed Critical Shl Medical Ab
Publication of WO2008098860A1 publication Critical patent/WO2008098860A1/fr

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
    • A61M5/3129—Syringe barrels
    • A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/062—Carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3106—Plugs for syringes without needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3123—Details having air entrapping or venting means, e.g. purging channels in pistons
    • 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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic

Definitions

  • the present invention relates to an arrangement for a medical device and in particular pressurized compartments containing medicament to be expelled to deliver a dose to a patient.
  • the nebulizers have a function such that medicament in liquid form is pressurized in a container and forced through a nozzle having a plurality of very small passages, in the region of ⁇ m. This causes the liquid to form a "mist" of very small droplets, which are inhaled by a patient.
  • containers for injecting devices which containers usually have a tubular body of glass, a stopper slidable in the body for expelling medicament and a needle attached to one end of the body.
  • the needle attachment is often a metal cap pressed onto a neck of one end of the body.
  • the centre of the metal cap is arranged with a passage covered with rubber, through which the needle projects.
  • Another drawback with the above mentioned container is that the needle projects through the rubber and a certain distance into the container. There is almost always a certain amount of air entrapped in the container because it is very difficult to completely fill the container and then close it. This entrapped air uses to be positioned around the projection of the needle into the rubber. Further, this amount of air is a problem within the application of injectors and especially within the application of nebulizers because the air bubble and the high pressures cause a resiliency that negatively affect the forming of the mist of droplets. Because the needle projects into the container the air bubbles will not be expelled through the needle, but will rather be entrapped around the needle during the whole process of emptying the container. The air bubbles may even disturb the forming of droplets to such an extent that the amount of medicament entering the lungs are much smaller than the expelled dose, where the rest instead causes a drooling from the device.
  • Document US 5,803,284 discloses a closure for a medicament containing container or vial.
  • the closure is arranged with an elastomeric closure for sealing an opening of a medicament container, including a plug which is pushed into the opening and a flange that rests on the upper surface of the container.
  • the plug is held in place by a washer and a crimp cap which surrounds a vial rim.
  • the vial is not intended to be under pressure and there is no information regarding the holding strength of the crimp cap. Further the plug is arranged with a conical surface where air could be entrapped.
  • document US 2,666,434 discloses a disposable manual syringe having a medicament compartment where the front end is arranged tapered towards a central opening, in which a hollow needle is attached. The tapering prevents any air inside the compartment from being trapped.
  • the syringe of US 2,666,434 has a container made in one piece by moulding in plastic, preferably polystyrene in order to reduce the cost. This makes it unsuitable for use in nebulizers where the interior of the containers are subjected to very high pressures.
  • the aim of the present invention is to provide a container which is capable of ensuring that any air enclosed in the container is expelled during the dose deliveries and also is capable of withstanding high pressures.
  • a container intended to be used in a medical delivery device, which medical delivery device is capable of exerting pressure inside said container, the container comprising a housing of generally tubular shape , a stopper arranged movably in said housing, a plug fixedly attached to one end of said housing and a passage opening arranged in said plug, through which passage a liquid medicament can be expelled from said housing, wherein the interior surface of said plug is shaped so as to direct air entrapped in the container through said passage when pressure is applied to the medicament via said medical delivery device.
  • said means for directing air entrapped in the container comprises a portion of said passage opening widening towards the inner surface of the housing.
  • Said portion of said passage opening could be shaped as a funnel.
  • said passage is arranged in a plug inserted in the housing and attached to the same.
  • the exterior surface of said plug is arranged with a sealing membrane.
  • said passage is arranged in a body of a passage creating member which is insertable in said plug.
  • said body is arranged with a central passage divide in two openings and with a pointed end capable of piercing said sealing membrane.
  • the pointed end when said body is inserted in said plug, is arranged in said air directing means, and wherein said central passage openings are arranged in the surface of said pointed end.
  • the inner part of the passage widens towards the inner walls of the container housing, thereby reducing the surfaces that could block the air from entering the passage.
  • a preferred form of the widening is a funnel-shape.
  • the front part of the container with the passage could be formed as a separate plug that is attached fixedly to the container housing, capable of withstanding the high pressures inside the container when delivering a dose of medicament.
  • the plug is arranged with a protective sealing membrane for ensuring the quality and sterility of the medicament before the container is used.
  • Said protective sealing membrane being an adhesive membrane that can be removed or a membrane of material such as rubber that must be broken or pierced.
  • a passage creating member is used for breaking or piercing the protective sealing membrane by a pointed end.
  • the medicament could be stored for long periods and the container be opened and a passage created just before the first use of the container.
  • the plug is preferably made of a rather stiff and non-elastic material, for reducing the resiliency inside the container when high pressures are applied to the medicament.
  • the plug is preferably arranged with sealing means for preventing medicament under high pressure from leaking out.
  • Fig. 1a is a side view of a medical delivery device comprising the present invention
  • Fig. 1 b is an end view of the device of Fig. 1 .
  • Fig. 2 is a longitudinal cross-section of the device of Fig. 1a
  • FIG. 3 shows a longitudinal cross-section of one embodiment of a container according to the present invention
  • FIG. 4a shows a longitudinal cross-section of another embodiment of a container according to the present invention
  • Fig. 4b shows a longitudinal cross-section taken 90 ° in relation to Fig. 4a
  • FIG. 5 shows a longitudinal cross-section of yet an embodiment of a container according to the present invention.
  • Fig. 6 shows a variant of a plug used with the present invention.
  • nebulizers a medical delivery device of the type capable of dispensing the medicament as very small droplets, normally called nebulizers.
  • FIG. 1 Such a device is shown in figures 1 and 2 where the outer housing has been removed for clarity.
  • the device comprises a front part 10, to the left in the figures, where the medicament delivery takes place and a rear part 30.
  • the front part comprises a medicament container holder 12 arranged with an elongated tubular space. This space can receive a medicament container or cartridge14, which will be explained in detail below.
  • the front part of the container holder is arranged with a neck part 16 arranged with external threads.
  • a cap 18 arranged with internal corresponding threads is threaded onto the neck.
  • the cap is arranged with a central opening, into which an end plug 20 of the container is placed.
  • the end plug is arranged with a circumferential ledge 22, which rests against the inner surface of the cap around the central opening.
  • the cap is also arranged with a central opening, in which a nozzle 24 is placed.
  • the nozzle is arranged with a plurality of very small passages, which are capable of creating very small droplets when a liquid is pushed through the passages.
  • the nozzle is held in place by a washer 26 attached to the cap by screws 28.
  • the rear part 30 of the device comprises dose setting and drive means.
  • the rear part of the container holder is arranged with internal threads which mate with external threads of a front tubular part 32 of a holder. The holder then widens to a larger diameter tubular part 34.
  • On the inside of the wider tubular part a nut 36 is attached with screws.
  • the nut is arranged with a central threaded passage.
  • a plunger rod 38 is threaded into the nut, where the front end of the plunger rod is in contact with a stopper 40 arranged in the container.
  • Adjacent the nut a locking member 42 is arranged, having a central opening through which the plunger rod extends.
  • the plunger rod is arranged with longitudinally extending cut-outs and the central opening has a corresponding shape, whereby the plunger rod is rotationally locked in relation to the locking member, but movable in the longitudinal direction.
  • the locking member is arranged with externally arranged grooves 44 directed in the longitudinal direction of the device.
  • the grooves mate with corresponding grooves arranged on the inner surface of a release member 46.
  • the release member is arranged with outwardly extending arms 48, which are placed in grooves of the holder.
  • a ring 50 is attached to the arm. The function of the release member will be described below.
  • the release member is held in a meshing position with the locking member by a compression spring 52.
  • a dose setting member 54 having a generally tubular shape is arranged around the plunger rod, having a front part in contact with the locking member.
  • the mating surfaces of the front part of the dose setting member and the locking member are arranged with saw-tooth shaped protrusions (not shown), whereby the dose setting member can be rotated in relation to the locking member in only one direction, as will be described below.
  • the dose setting member is rotatably attached to a dose setting knob 56, protruding to the rear of the device.
  • the dose setting member is however axially movable to the dose setting knob.
  • a flat spiral spring 58 is arranged in a spring housing 57, which in turn is attached to the base structure of the device.
  • the outer end of the spiral spring is attached to the spring housing, and the inner end of the spiral spring is attached to the dose setting member 54.
  • the device is intended to function as follows.
  • a container 14 is inserted in the container holder 12, which in turn is threaded onto the rear part 32 of the device.
  • the dose setting knob 56 is turned. This causes the dose setting member 54 to turn and because the spiral spring 58 is attached to the dose setting member, the spring is tensioned.
  • the dose setting member is turned in relation to the locking member 42 because this is held rotationally fixed by the cooperating grooves 44 of the dose release member 46.
  • the saw-toothed protrusions of the dose setting member and the locking member act to allow rotation in one direction and to prevent the dose setting member from rotating back when a certain dose has been set.
  • the release member 46 When a dose is to be delivered the release member 46 is moved towards the back of the device whereby the cooperating grooves 44 of the locking member and the release member are moved out of contact with each other.
  • the locking member 42 connected to the dose setting member, is now free to rotate, and due to the force of the spiral spring 58 acting on the dose setting member 54, the locking member is rotated. Because of the rotational lock between the locking member 42 and the plunger rod 38, the latter will also rotate and because of the threads of the plunger rod co-acting with the threads of the nut 36, the plunger rod is moved forward. This forward movement causes the stopper 40 to be moved forward, building up a pressure inside the container. This pressure causes the medicament to be pressed through the very small passages of the nozzle 24, thereby creating a "mist" of very fine droplets. The delivery of medicament is terminated when the dose setting member has rotated back to its original position.
  • the above described device utilizes a container according to the present invention, where one embodiment is shown in figures 2-3. It comprises a generally tubular body 60 with a stopper 40 in the rear end, as mentioned above.
  • the stopper could be made of a rather stiff, non-elastic material for reducing the resiliency of the container when pressure is built up inside.
  • the stopper is arranged with a number of sealing means 62 arranged around the circumference of the stopper, such as rubber O-rings for ensuring a tight seal between the stopper and the housing.
  • the stopper can alternatively be covered with a sealing rubber cap (not shown).
  • the interior of the rigid stopper can be shaped to receive the rotating plunger rod of the device in order to decrease the friction between said plunger rod and said stopper.
  • the front end of the container is arranged with a specially designed plug 64.
  • This plug may also be made of a rather stiff, non-elastic, material, for the same reason as for the stopper.
  • This plug is also arranged with a number of sealing means 66 arranged around the circumference of the plug.
  • the plug is arranged with a central passage 68 extending through the plug from the interior of the container to the front surface of the plug.
  • the passage is designed with a funnel-like shape 70, i.e. the passage diameter at the inner surface of the plug is larger, and is reduced as the passage extends towards the front end.
  • the exterior surface of said plug 64 is arranged with an adhesive sealing membrane 67. This is the state that the medicament container is stored and delivered to a patient, where the adhesive sealing membrane ensures the quality of the medicament.
  • the patient removes said adhesive sealing membrane. The plug is held in place on the container by the cap 18, Fig. 2, threaded onto the container holder of the device, thereby ensuring that the plug is held in place even during very high pressures in the container.
  • FIGS 4a and 4b show another embodiment of the present invention.
  • the plug 80 is preferably made of a rather stiff, non-elastic material.
  • the plug is further arranged with an outer cap 82, where the lower part of the inner surface of the cap is arranged with an inwardly directed circumferential ledge 84, which has a bevelled surface.
  • the container housing is arranged with a circumferential groove 86 into which the ledge fits when the plug with the cap is pressed onto the front end of the container holder of the device.
  • a seal ring 88 is arranged between the front surface of the housing and the plug 80.
  • This seal ring is compressed to allow a proper sealing when the circumferential ledge enters the groove of the housing.
  • the bevelled surface of the ledge facilitates the mounting of the plug 80 on the housing.
  • the plug 80 is arranged with a passage 90 having a certain shape, as will be described below.
  • a sealing cap 92 is attached, by for example threads or adhesive or any other suitable means.
  • the sealing cap has a central opening 94 and on the inner surface facing the plug 80, an annular spacer 96. Inside the spacer 96 and covering the central opening of the sealing cap, a sealing membrane 98 is arranged. This could comprise a resilient, medicament safe, material such as rubber. This is the state that the medicament container is stored and delivered to a patient, where the sealing cap with the membrane ensures the quality of the medicament.
  • a passage creating member 100 When a patient is to use the container for dose delivery, the membrane is broken by a passage creating member 100.
  • Said member 100 is arranged with a pointed tip end 102 capable of piercing or rupturing the membrane 98, when pushed through the central opening 94 of the sealing cap 92.
  • Said passage creating member 100 comprises also a body 104 having a conical shape, wherein said shape corresponds to the conical shape of the passage 90 of the plug 80, such that when the member 100 is pushed further into the plug 80, a wedge-like sealing action is obtained between the body 104 and the passage 90.
  • the tip 102 is now placed in the inner part of the passage 90 of the plug 80, which inner passage has a funnel-like shape 91 as the previous embodiment, thus ensuring that no air can be entrapped inside the container.
  • the passage creating member 100 is arranged with a central passage 108. At the tip the central passage is divided in two obliquely arranged openings 110, which communicate with the funnel-shaped space. Thus a passage is created between the interior of the container and the front end of the passage creating member 100. When inserted in the medicament delivery device, the front end of the passage creating member is abutting fixed surfaces of the device (not shown), thereby ensuring that the pressure inside the container cannot push the passage creating member out of the plug 80.
  • the central passage 108 of the passage creating member is in communication with the nebulizing nozzle for creating the mist of very small droplets. Further, it is also to be understood that the central passage 108 of the passage creating member can also be an injection needle.
  • the front end of the container can be modified in many ways in order to ascertain the desired function of expelling entrapped air.
  • Normally glass is used as material for medicament containers of this type, which material cannot react with or affect the medicament contained therein.
  • plastic materials that have been developed that display the same properties as glass regarding not affecting the medicament.
  • a container, Fig. 5 having a front end integrated with the housing where the passage is arranged with a funnel-shaped inner part, for ensuring that air is expelled from the container during initial dispensing of medicament.
  • the integrated front end will also have the necessary strength for handling the pressures that build up for these applications.
  • the outer surface of front end of said container can be arranged with threads or grooves that cooperate with threads or ledges of a cap (not shown) of the passage creating member 100.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

La présente invention porte sur un contenant destiné à être utilisé dans un dispositif d'administration médical pouvant exercer une pression à l'intérieur dudit contenant. Le contenant est muni d'un boîtier de forme généralement tubulaire ; d'une butée disposée de façon mobile dans ledit boîtier ; d'un bouchon solidement fixé à une extrémité dudit boîtier et dans lequel est pratiquée une ouverture de passage disposée à travers lequel un médicament liquide peut être expulsé dudit boîtier. La surface intérieure du bouchon est configurée pour diriger l'air piégé dans le contenant à travers le passage lorsqu'une pression est appliquée au médicament par le dispositif d'administration médical.
PCT/EP2008/051415 2007-02-14 2008-02-05 Contenant pour dispositif médical WO2008098860A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US88979507P 2007-02-14 2007-02-14
SE0700411-2 2007-02-14
SE0700411 2007-02-14
US60/889,795 2007-02-14

Publications (1)

Publication Number Publication Date
WO2008098860A1 true WO2008098860A1 (fr) 2008-08-21

Family

ID=39399238

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2008/051415 WO2008098860A1 (fr) 2007-02-14 2008-02-05 Contenant pour dispositif médical

Country Status (1)

Country Link
WO (1) WO2008098860A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011133089A1 (fr) * 2010-04-19 2011-10-27 Shl Group Ab Dispositif de distribution de médicaments pour auto-administration
TWI507224B (zh) * 2008-12-19 2015-11-11 Sanofi Aventis Deutschland 藥物輸送裝置及用於該藥物輸送裝置之互鎖機構

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB482714A (en) * 1936-08-12 1938-04-01 Novocol Chemical Mfg Company O Improvements in or relating to medicament containers for hypodermic syringes and to methods for preparing said containers
GB743789A (en) * 1953-02-22 1956-01-25 Hubert Percival Schofield Improvements in or relating to cartridges and the like tubular containers for use in dispensing liquids
GB1372549A (en) * 1971-07-01 1974-10-30 Ims Ltd Injector device
US3916893A (en) * 1973-03-28 1975-11-04 Hoechst Ag Single-injection device
US4720285A (en) * 1984-11-21 1988-01-19 Ewald Pickhard Injection syringe
WO2001074424A2 (fr) * 2000-04-03 2001-10-11 Astrazeneca Uk Limited Seringue pre-remplie
WO2003015853A1 (fr) * 2001-08-07 2003-02-27 Riemser Arzneimittel Ag Ampoule pour dispositif d'injection
US20040138611A1 (en) * 2000-10-10 2004-07-15 Meridian Medical Technologies, Inc. Wet/dry automatic injector assembly
EP1683537A1 (fr) * 2005-01-25 2006-07-26 Pfizer Health AB Dispositif d'injection pour administrer un liquide médical

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB482714A (en) * 1936-08-12 1938-04-01 Novocol Chemical Mfg Company O Improvements in or relating to medicament containers for hypodermic syringes and to methods for preparing said containers
GB743789A (en) * 1953-02-22 1956-01-25 Hubert Percival Schofield Improvements in or relating to cartridges and the like tubular containers for use in dispensing liquids
GB1372549A (en) * 1971-07-01 1974-10-30 Ims Ltd Injector device
US3916893A (en) * 1973-03-28 1975-11-04 Hoechst Ag Single-injection device
US4720285A (en) * 1984-11-21 1988-01-19 Ewald Pickhard Injection syringe
WO2001074424A2 (fr) * 2000-04-03 2001-10-11 Astrazeneca Uk Limited Seringue pre-remplie
US20040138611A1 (en) * 2000-10-10 2004-07-15 Meridian Medical Technologies, Inc. Wet/dry automatic injector assembly
WO2003015853A1 (fr) * 2001-08-07 2003-02-27 Riemser Arzneimittel Ag Ampoule pour dispositif d'injection
EP1683537A1 (fr) * 2005-01-25 2006-07-26 Pfizer Health AB Dispositif d'injection pour administrer un liquide médical

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI507224B (zh) * 2008-12-19 2015-11-11 Sanofi Aventis Deutschland 藥物輸送裝置及用於該藥物輸送裝置之互鎖機構
WO2011133089A1 (fr) * 2010-04-19 2011-10-27 Shl Group Ab Dispositif de distribution de médicaments pour auto-administration
TWI421109B (zh) * 2010-04-19 2014-01-01 Shl Group Ab 藥物輸送裝置
US9095657B2 (en) 2010-04-19 2015-08-04 Shl Group Ab Self-administration medicament delivery device

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