EP1851135A1 - Vorrichtung zur ausgabe von fluiden, besonders arzneifluiden unter druck - Google Patents

Vorrichtung zur ausgabe von fluiden, besonders arzneifluiden unter druck

Info

Publication number
EP1851135A1
EP1851135A1 EP06709317A EP06709317A EP1851135A1 EP 1851135 A1 EP1851135 A1 EP 1851135A1 EP 06709317 A EP06709317 A EP 06709317A EP 06709317 A EP06709317 A EP 06709317A EP 1851135 A1 EP1851135 A1 EP 1851135A1
Authority
EP
European Patent Office
Prior art keywords
container
edge
opening
bag
sleeve
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.)
Granted
Application number
EP06709317A
Other languages
English (en)
French (fr)
Other versions
EP1851135B8 (de
EP1851135B1 (de
EP1851135B2 (de
Inventor
Chris Nimmo
Olivier Bertaud
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.)
Power Container Corp
Original Assignee
Laboratoires Goemar SA
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36337617&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP1851135(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from FR0501511A external-priority patent/FR2882037B1/fr
Application filed by Laboratoires Goemar SA filed Critical Laboratoires Goemar SA
Priority to PL06709317T priority Critical patent/PL1851135T5/pl
Publication of EP1851135A1 publication Critical patent/EP1851135A1/de
Publication of EP1851135B1 publication Critical patent/EP1851135B1/de
Publication of EP1851135B8 publication Critical patent/EP1851135B8/de
Application granted granted Critical
Publication of EP1851135B2 publication Critical patent/EP1851135B2/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D83/00Containers or packages with special means for dispensing contents
    • B65D83/14Containers or packages with special means for dispensing contents for delivery of liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant for a product delivered by a propellant
    • B65D83/60Contents and propellant separated
    • B65D83/62Contents and propellant separated by membrane, bag, or the like

Definitions

  • the subject of the invention is a device of the type that is capable of delivering fluids, in particular medicinal fluids, under pressure.
  • fluids, and mainly liquids containing medicinal or cosmetic substances, or constituted by natural products that may be modified or adapted must be delivered under pressure for the needs of their use.
  • the fluid is delivered not under the action of a propellant but under the action of a mechanical stress which is exerted on a container in the form of a pocket or bag of variable volume and of cylindrical general shape with longitudinal folds, filled with the fluid to be delivered.
  • the sleeve in question is then put in place and the fluid to be delivered is introduced under pressure into the container which expands against the opposite action.
  • elastic sleeve whose compression force exerted on the container increases with the expansion thereof as a result of the filling by the fluid to be delivered.
  • a container of variable volume intended to be filled with the fluid to be delivered and also equipped with a control adapted to actuate a valve to allow the delivery of the fluid under pressure
  • a container of variable volume intended to be filled with the fluid to be delivered and also equipped with a control adapted to actuate a valve to allow the delivery of the fluid under pressure
  • this outer container is filled with a pressurized neutral gas, the empty variable volume container being in place, then the latter is filled with the fluid to be delivered by the introduction of the latter under a pressure sufficient to overcome the pressure exerted on the container by the neutral gas filling the outer container, which has the effect of further increasing the pressure of the neutral gas.
  • the stress exerted on the inner container of variable volume and by virtue of which the pressurized fluid can be delivered is therefore pneumatic in nature.
  • the object of the invention is, above all, to overcome the disadvantages of the prior art and to make available to the user a device of the kind in question free from the drawbacks of those which already exist.
  • the device according to the invention capable of delivering
  • Fluids, in particular medicaments, under pressure is characterized in that it comprises a container of variable volume in the form of a bag or bag of cylindrical general shape with longitudinal folds containing the pressurized fluid to be delivered and provided with a control for opening a valve for delivering said liquid, the assembly being disposed inside a container
  • the aforesaid valve allowing this delivery is actuated by the aforesaid command.
  • the outer container of the device of the invention is intended to contain a gas under pressure, it must therefore be capable of withstanding a pressure greater than 5 bar, preferably greater than 8 bar, more preferably
  • variable volume container containing the fluid to be delivered and the external pressure-resistant container are made of transparent materials, so that the user sees the fluid and can know at any time the filling state of the device. Similarly, any alteration of the fluid that would lead to a change in the appearance thereof (coloring, phase shift, etc.) can be detected by the user.
  • Figure 1 is an external schematic elevational view of a device according to to the invention
  • Figure 2 is a sectional view on a larger scale according to 2-2 figure
  • FIG. 3 is a partial view in section on a larger scale of the device according to FIG. 1.
  • the device according to the invention comprises a container 1 generally designated by 1, in the form of bag or bag of variable volume, of generally cylindrical shape with longitudinal folds or ribs 2, closed at one of its ends Ei and having at its other end an edge opening 3 carried by a cylindrical extension E 2 , an outer container 4 also cylindrical having an opening on the edge 5 and inside which is disposed the container 1, a fixing sleeve generally designated by M connecting the containers 1 and 2 which has a periphery or edge Mi and an axial circular opening a edge 12, a push button command generally designated by C, disposed on the opening of the container 1, the fixing sleeve M being set by its periphery Mi on the edge 5 of the container 4 and its central portion having the axial opening with edge 12 on the extension E 2 near the edge 3.
  • the fixing sleeve M preferably made of aluminum or tin-plated steel or tinplate (steel having a layer of tin on each side).
  • the outer container 4 can be used also commercially available aerosol containers, especially those whose opening delimited by the edge 5 has a diameter of 25.4 mm, said sleeve being crimped on the edge 5.
  • the containers 1 and 4 can each be made using laminates, at least one of the constituent layers gives the laminate sufficient mechanical strength, another layer can confer gas barrier properties, including oxygen, nitrogen and / or carbon dioxide, and / or another layer that can confer chemical resistance properties vis-à-vis the fluid to be delivered.
  • a layer capable of imparting good mechanical strength properties may for example be made of polyethylene terephthalate or PET.
  • a layer capable of imparting good gas barrier properties may, for example, be made of nylon, especially nylon MXD6, of ethylene-vinylalcohol resin (or EVOH) or of silicon oxide.
  • the container 1 can be made of a laminate of PET / Nylon / PET type, that is to say having an outer layer of polyethylene terephthalate, an intermediate layer of nylon and an inner layer, that is to say a layer intended to be in contact with the fluid to be delivered also, polyethylene terephthalate; it can also be made of a PET / EVOH / PET type laminate.
  • E ⁇ ⁇ recipienf ⁇ 4 can be made of the same material. However, in view of the fact that this constituent material of this container is not in contact with the fluid to be delivered, it is quite possible to use a two-layer laminate, for example polyethylene terephthalate and nylon.
  • Such a material lacking an internal layer conferring a chemical resistance may also be used for producing the container 1 insofar as the fluid to be delivered is chemically compatible with the other layers.
  • Such laminates can be made by using coextrusion or co-injection techniques using technologies such as those developed by KORTEC Inc. Ipswich, MAO 1938, USA.
  • a layer for example of silicon oxide
  • the layer thus deposited can be extremely thin, only a few microns thick.
  • the technology to be implemented is, for example, that developed by SIG CORPOPLAST Inc. under the name PLASMAX.
  • Such a layer may be deposited on a conventional monolayer material or on a laminate obtained by coextrusion or co-injection.
  • the inner container 1 and outer 4 of the sprayer according to the invention are made of a transparent synthetic material.
  • the invention proposes to overcome this disadvantage by proceeding as described below; it provides two solutions to the problem in question, these two solutions each involved at a different stage of the manufacture of the inner container 1.
  • This container of variable volume and which is in the form of a bag or bag of generally cylindrical shape with longitudinal folds, is prepared in two stages, respectively step A and step B.
  • the container of variable volume in the shape of a bag or bag of generally cylindrical shape is established, its wall being flat and in the second step or step B, this wall is given the longitudinal folds 2 which appear in particular in Figures 1 and 2.
  • K blank made by injection into a first mold
  • axial section in Figure 4 which is established in the synthetic material of the container to be prepared and which is in the form a cylindrical tube closed at its end K1 and open at its other end, K2, said cylindrical tube being slightly conical (with an apex angle of 1 ° to 5 °), the top of the cone at K1 having a protuberance K3; the protuberance K3 is designated by the term "door” and corresponds to the point of introduction of the pressurized fluid synthetic material into the mold.
  • the second mold it is subjected to a mechanical elongation carried out using a stylet element S introduced through the opening of the blank and whose end Sl exerts an axial mechanical effect on the bottom of the blank at its end K1; it is important that the protuberance K3 moves along the axis under the action of the stylet towards the center of the bottom of the blow mold; the aforesaid mechanical elongation is combined with a blow molding inside the second mold according to the process designated in the art by the term "stretch blow"; this second mold has the shape and the dimensions which make it possible to obtain directly the bag or bag of generally cylindrical shape constituting the container 1 which at this stage does not yet comprise the longitudinal folds 2.
  • the blank Under the effect of the pressure exerted by the compressed air, the blank extends in all directions.
  • the extension of its constituent material which is advantageously polyethylene terephthalate or PET, is accompanied by an increase in its resistance to fracture; this extension makes the thickness of the walls of the container thinner. It is this technique which is designated by the term “biaxial expansion extension” or by “biaxial stretch elongation” or " nxrore ⁇ ar ⁇ StreixdfiFBixTV ⁇ ⁇ :
  • this first step or step A namely the element used for mechanical elongation and the second mold for performing blow molding or injection molding, are marketed in particular by the company NISSEI ASB Company, 125 Westlake. Parkway, Suite 120, ATLANTA, Georgia 30336 USA.
  • the pouch is printed with a bag of generally cylindrical shape and whose wall is still flat, the longitudinal folds and ribs 2 appearing in FIGS. 1 and 2 using recourse for example to a device of the type described in US Pat. No. 4,701,120, more particularly from line 50, column 1 to line 30, column 2.
  • This device comprises the elements which in the art are designated by "pallets” and thanks to which the folds and / or longitudinal ribs can be printed on the wall of the bag to the bag of generally cylindrical shape.
  • the container resume the shape that was hers before the introduction of the fluid to be delivered, according to the invention, one proceeds as follows or in a similar manner.
  • the folds or ribs 2 of the container In a first embodiment, the folds or ribs 2 of the container
  • the 16 blanks 21 comprising the bag or bag of variable volume obtained at the end of the first step or step A coincide with the parts of the device used in the second step or step B during which the 16 pallets of this device print the bag or pocket of variable volume the final ribs 2.
  • p is "ut ⁇ ry ⁇ Orr ⁇ orter to the a end E2 of the bag or pocket volume variable a split ring 23 shown in Figure 7 which provides the desired positioning as described below.
  • This split ring 23 makes it possible to carry the bag or bag of variable volume inside the mechanism which conveys it to the folding head at which the ribs 2 are made from the blanks 21, previously formed by means of the conformation of the inner wall of the blow mold.
  • a mechanism may be envisaged comprising a pawl or stop actuated under the influence of a spring which ensures that when the pawl or abutment is at the level of the cut of the split ring, it enters this cut to block the rotation bag or pouch of variable volume thus ensuring the desired positioning.
  • the support which maintains the bag or bag of variable volume inside the plug head is so designed that it allows this rotation by means of a pneumatic rotary motor which, under the effect of a command, rotates said bag or pocket inside the gripper head to the position in which the pawl or stop engages the cutout provided in the split ring to stop the bag or pouch in the desired position.
  • the folding of the container 1 is carried out so that it resumes its initial shape after all the fluid to be delivered has been used.
  • said bag or bag returns to its original shape which is the one it has at the end of the second step or step B, it is put in place on the container 1 with longitudinal folds 2 a cylindrical sleeve R shown in section perpendicular to its axis ZZ in FIG. 8; this sleeve R is made of transparent elastic synthetic material and has at its inner surface longitudinal ribs primer 25 parallel to the axis ZZ in the same number as the longitudinal folds or ribs 2 formed by the container 1 of variable shape so that the rib primers comprised by the cylindrical sleeve are respectively positioned respectively between two ribs 2 of the bag or pouch of variable volume 1.
  • the sleeve R remains permanently in position on the container 1. To ensure the positioning, during assembly, of the sleeve R relative to the bag or bag of variable volume 1, it is possible to use a split ring of the same type as the ring 23 of the first embodiment and which is positioned at the open end of the bag or pouch of variable volume 1, as shown in Figure 7.
  • the container 1 Due to the presence of the sleeve R, the container 1 is folded in a regular manner, returning the container to its original shape once all the fluid to be delivered has been used.
  • FIG. 3 shows in detail the constituent parts of the device according to the invention according to the present advantageous embodiment.
  • the seal on the one hand, at the crimping of the fixing sleeve M on the extension E2 near the 3 edge of the opening of the container 1, is provided by a seal 8 of elastomeric material, including rubber and, secondly, at the crimping of the same sleeve on the edge 5 of the opening of the container 4 by a gasket 9 made of the same material as gasket 8.
  • the seal 9 in the case where the container 4 is made of a material having sufficient elasticity characteristics, for example polyethylene terephthalate or any similar synthetic material.
  • the tightness of the packaging will then be ensured directly during crimping between the edge 5 of the container and the sleeve M because of the elastic properties of the material.
  • the absence of seal allows a reduction of the cost.
  • the crimping of the sleeve M on the end of the extension E 2 of the container 1 is made possible by an outer rim 10 provided at its end.
  • the container 1 may be surrounded by an elastic cylindrical sleeve 11 which is advantageously made of synthetic material, in particular polyvinylethylene, the function of which is to protect the container 1.
  • the sleeve M has a central circular opening whose edge is shown at 12.
  • the control C which is in the form of a push button, has a general shape of hat-shaped case, as shown in Figure 3, preferably made of rigid synthetic material, especially high density polyethylene; it comprises an axial tube 13 with an internal axial duct 13a which, on the one hand, communicates at its upper end 13b with a duct 14 formed in the upper part C 1 of the control and connected to the tube 13 and, on the other hand , opening through its lower end 13c, when in place as shown in Figure 3 on the device according to the invention, in the part E 2 of the container 1 through the opening 12 of the attachment sleeve M , the gasket 8 being arranged in such a way that it also seals with the tube 13 as visible.
  • the command ⁇ ⁇ C ⁇ is ⁇ doric dis3J0 ⁇ eV ⁇ t ⁇ a ⁇ n1 ⁇ mrare ⁇ n ⁇ plHce " ⁇ uri'extrémotti
  • the end 13c of the tube 13 is supported on a valve constituted by a cup-shaped element having a bottom 15a and a wall 15b; at the end 13c, the tube 13 has an opening or notch 13d.
  • the element 17 has an axial opening 17c for communicating the interior of the container 1 with the interior of the space delimited by the element 17. To deliver the fluid under pressure contained in the container 1, it is sufficient to exert on the control C towards the container 1 a pressure greater than that with which the spring 16 applies the bottom 15a of the cup against the end 13c of the tube 13 which has the effect of moving the free edge of the wall 13b away from the gasket 8.
  • the fluid under pressure contained in the container 1 can then pass between the free edge of the wall 15b and the gasket 8 towards the inside of the cup and by the notch 13d provided at the end 13c of the tube 13 in the axial duct 13a and then through the conduit 14 to the outside in the desired form.
  • the container 1, on which the fixing sleeve M has been attached after placing the gasket 8, is preferably emptied of most of the air contained therein.
  • the assembly is then fixed, after placing the gasket 9, by crimping on the outer container 4 in which the container 1 is housed, and the outer surface of the container 1 of the air or the pressurized neutral gas in an amount such that the pressure reaches a value preferably of between about 1.5 and about 3.5 bar, the precise value chosen being a function of the nature of the fluid to be issue.
  • a suitable tool for example a degassing and crimping head of the type marketed by Pamasol Willi Maeder AG, Driesbuelstrasse 2, CH-8808 Pfaffikon , SZ Switzerland under the name "UTC Head”.
  • This tool makes it possible to seal the upper surface of the container 4 and slightly raises the sleeve M, using a vacuum connection to suck the sleeve into a seat, and to allow the introduction under pressure of a neutral gas or compressed air.
  • the sleeve M is pressed on the edge 5 of the container 4 and the head and crimping is performed between the sleeve M and the container 4.
  • sufficient pressure is maintained by the head to compress the seal 9 and thus ensure a good sealing between the sleeve M and the container 4.
  • the container 1 is then filled with the fluid intended to be delivered under pressure.
  • This dosing unit generally comprises a volumetric dosing device under high pressure, and a filling nozzle. After crimping the sleeve M on the container 4, the assembly is positioned under a filling nozzle which is part of the conditioning unit and the nozzle is actuated to descend and seal on the sleeve. An adapter seals on the upper part 12 of the sleeve and the fluid is introduced under pressure through the valve 15 to fill the container 1.
  • the pressure of the air or neutral gas between the wall of the container 4 and the container 1 increases to generally reach a value between about 4 and about 10 bar, the precise value chosen being a function of the nature of the fluid to be delivered.
  • Control C is then put in place and the device according to the invention is ready for use. Following which, and regardless of the embodiment adopted, there is thus a device of the kind in question whose characteristics are sufficiently resulting from the foregoing so that it is useless to insist on this subject, this device presenting, in comparison with those already existing, many advantages including that of a high reliability, that of great strength and that of a competitive cost price.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
  • Filling Or Discharging Of Gas Storage Vessels (AREA)
  • Jellies, Jams, And Syrups (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
EP06709317.9A 2005-02-15 2006-02-14 Vorrichtung zur ausgabe von fluiden, besonders arzneifluiden unter druck Active EP1851135B2 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PL06709317T PL1851135T5 (pl) 2005-02-15 2006-02-14 Urządzenie do uwalniania płynów, w szczególności leczniczych, pod ciśnieniem

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR0501511A FR2882037B1 (fr) 2005-02-15 2005-02-15 Dispositif apte a delivrer des fluides, notamment medicamenteux sous pression
FR0511571 2005-11-15
PCT/FR2006/000338 WO2006087462A1 (fr) 2005-02-15 2006-02-14 Dispositif apte a delivrer des fluides, notamment medicamenteux sous pression

Publications (4)

Publication Number Publication Date
EP1851135A1 true EP1851135A1 (de) 2007-11-07
EP1851135B1 EP1851135B1 (de) 2008-07-16
EP1851135B8 EP1851135B8 (de) 2008-10-01
EP1851135B2 EP1851135B2 (de) 2015-08-12

Family

ID=36337617

Family Applications (1)

Application Number Title Priority Date Filing Date
EP06709317.9A Active EP1851135B2 (de) 2005-02-15 2006-02-14 Vorrichtung zur ausgabe von fluiden, besonders arzneifluiden unter druck

Country Status (9)

Country Link
US (1) US20080272145A1 (de)
EP (1) EP1851135B2 (de)
AT (1) ATE401259T1 (de)
CA (1) CA2597693C (de)
DE (1) DE602006001851D1 (de)
ES (1) ES2310909T5 (de)
PL (1) PL1851135T5 (de)
PT (1) PT1851135E (de)
WO (1) WO2006087462A1 (de)

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US9409698B2 (en) 2011-03-02 2016-08-09 Greenspense Ltd. Propellant-free pressurized material dispenser
US9758641B2 (en) 2011-07-11 2017-09-12 T.G.L. S.P. Industries Ltd. Nanoclay hybrids and elastomeric composites containing same
US10913836B2 (en) 2013-01-16 2021-02-09 Greenspense Ltd. Elastomeric composites exhibiting high and long-lasting mechanical strength and elasticity and devices containing same
US10934076B2 (en) 2013-01-16 2021-03-02 Greenspense Ltd. Propellant-free pressurized material dispenser

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Publication number Priority date Publication date Assignee Title
US9409698B2 (en) 2011-03-02 2016-08-09 Greenspense Ltd. Propellant-free pressurized material dispenser
US10683159B2 (en) 2011-03-02 2020-06-16 Greenspense Ltd. Propellant-free pressurized material dispenser
US9758641B2 (en) 2011-07-11 2017-09-12 T.G.L. S.P. Industries Ltd. Nanoclay hybrids and elastomeric composites containing same
US10519297B2 (en) 2011-07-11 2019-12-31 T.G.L. S.P. Industries Ltd. Nanoclay hybrids and elastomeric composites containing same
US10913836B2 (en) 2013-01-16 2021-02-09 Greenspense Ltd. Elastomeric composites exhibiting high and long-lasting mechanical strength and elasticity and devices containing same
US10934076B2 (en) 2013-01-16 2021-03-02 Greenspense Ltd. Propellant-free pressurized material dispenser

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PL1851135T3 (pl) 2009-02-27
PT1851135E (pt) 2008-10-28
ATE401259T1 (de) 2008-08-15
EP1851135B8 (de) 2008-10-01
WO2006087462A1 (fr) 2006-08-24
US20080272145A1 (en) 2008-11-06
DE602006001851D1 (de) 2008-08-28
CA2597693A1 (fr) 2006-08-24
PL1851135T5 (pl) 2015-12-31
ES2310909T5 (es) 2015-11-26
EP1851135B1 (de) 2008-07-16
ES2310909T3 (es) 2009-01-16
CA2597693C (fr) 2014-10-07
EP1851135B2 (de) 2015-08-12

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