EP1572336B1 - Device for producing medical foam - Google Patents

Device for producing medical foam Download PDF

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Publication number
EP1572336B1
EP1572336B1 EP03795826A EP03795826A EP1572336B1 EP 1572336 B1 EP1572336 B1 EP 1572336B1 EP 03795826 A EP03795826 A EP 03795826A EP 03795826 A EP03795826 A EP 03795826A EP 1572336 B1 EP1572336 B1 EP 1572336B1
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EP
European Patent Office
Prior art keywords
foam
chamber
gas
connecting element
pistons
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EP03795826A
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German (de)
French (fr)
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EP1572336A1 (en
EP1572336B2 (en
Inventor
Jan-Christoph Wollmann
Dorothee Schliephake
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Chemische Fabrik Kreussler and Co GmbH
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Chemische Fabrik Kreussler and Co GmbH
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00Flow mixers; Mixers for falling materials, e.g. solid particles
    • B01F25/30Injector mixers
    • B01F25/31Injector mixers in conduits or tubes through which the main component flows
    • B01F25/311Injector mixers in conduits or tubes through which the main component flows for mixing more than two components; Devices specially adapted for generating foam
    • B01F25/3111Devices specially adapted for generating foam, e.g. air foam
    • B01F25/31112Devices specially adapted for generating foam, e.g. air foam with additional mixing means other than injector mixers, e.g. screen or baffles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00Other mixers; Mixing plants; Combinations of mixers
    • B01F33/50Movable or transportable mixing devices or plants
    • B01F33/501Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
    • B01F33/5011Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use portable during use, e.g. hand-held
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00Flow mixers; Mixers for falling materials, e.g. solid particles
    • B01F25/40Static mixers
    • B01F25/45Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads
    • B01F25/451Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by means for moving the materials to be mixed or the mixture
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00Flow mixers; Mixers for falling materials, e.g. solid particles
    • B01F25/40Static mixers
    • B01F25/45Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads
    • B01F25/452Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by elements provided with orifices or interstitial spaces
    • B01F25/4522Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by elements provided with orifices or interstitial spaces the components being pressed through porous bodies, e.g. flat plates, blocks or cylinders, which obstruct the whole diameter of the tube
    • B01F25/45221Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by elements provided with orifices or interstitial spaces the components being pressed through porous bodies, e.g. flat plates, blocks or cylinders, which obstruct the whole diameter of the tube the porous bodies being cylinders or cones which obstruct the whole diameter of the tube, the flow changing from axial in radial and again in axial

Definitions

  • the invention relates to a device for producing in particular reproducible medical foam or bubble suspension from a gaseous and a liquid medium.
  • the invention relates to a mixing device for the reproducible preparation and administration of injectables - such as e.g. Sclerosing agents, diagnostics, therapeutics, homeopathic remedies and autologous blood.
  • Sclerotherapy is the planed elimination of intra-, subcutaneous and / or transfascial varices and the sclerotherapy of subfascial vessels in venous malformations by injecting a sclerosing agent.
  • the various sclerosing agents cause damage to the endothelium of the vessels. This is followed by a secondary vascular occlusion and, in the longer term, the transformation of the veins into a connective tissue strand, to sclerosis.
  • the aim of the sclerotherapy is the definitive transformation into a fibrous strand. This can not recanalize and corresponds in its functional result to the surgical procedure for the removal of a varix.
  • the sclerotherapy with foamed sclerosants is becoming increasingly important.
  • the foam stays longer in the vein.
  • surface-active sclerosing agents such as polidocanol
  • polidocanol are usually brought into a foam-like state by reciprocating between two syringes or by shaking and then conventionally injected.
  • a mixing device for producing medical foam or for producing bubbles is known from EP 0 564 505.
  • a mixer with a helical mixing element is an additional element that can be permanently connected to a syringe.
  • the medium passes into the mixer, which contains the gas in a defined volume and type,
  • gas phase and liquid phase along the helical mixing element are mixed. This can produce a therapeutic and / or diagnostic foam.
  • the mixing device described in EP 0 564 505 has the disadvantage that the mixer, which is firmly connected to the syringe, in particular when the solution is moved back and forth, can easily be broken off or tilted due to the long lever. Furthermore, the mixer is a component which, due to the spiral-shaped mixing elements arranged in the mixer, can only be produced as an injection-molded part using elaborate injection molds.
  • a dual chamber syringe connected to a static mixer capable of producing foam is disclosed in US-A-3767085.
  • the object of the invention is to provide a device with which medical foam can be generated from a gaseous and a liquid medium in a simple manner.
  • the device according to the invention has an active substance chamber and a gas chamber. Both chambers are closed with one piston each. Furthermore, the device has a foam generator, which in particular has one or more screens. Both the drug chamber and the gas chamber are connected directly or indirectly to the foam generator. According to the invention, the two pistons are arranged displaceably in the respective chamber. In particular, the two pistons are connected together or connectable during actuation of the device, so that the two pistons are displaced together in each case in one of the two chambers. This results in an increase in the pressure in the chambers and thus conveying or transporting the active substance and the gas in the direction of the foam generator or through the foam generator therethrough.
  • the device according to the invention is thus very easy to handle, as moved by a movement both pistons and thus both media are pressed or transported in the direction of the foam generator.
  • the emerging from the foam generator medical foam then only needs to be collected, but can also be applied directly.
  • a reciprocation of a gas and a liquid or a gas and a detergent between two syringes is not required.
  • the production of a standardized sterile foam is thus considerably easier.
  • the provision of a compressed gas container in the device according to the invention is not required.
  • the two pistons are connected to one another via a connecting element.
  • the connecting element is in this case preferably configured such that one of the two chambers is opened during displacement of the connecting element.
  • the connection of the two pistons takes place only by the actuation of the device.
  • the connecting element is particularly preferred in this case to form the connecting element as a conveying channel, for example as a hollow needle.
  • a driving element which may be formed in particular as a bead or plate. This makes it possible, when moving the connecting element in the direction of one of the two chambers closing the piston after the example piercing or opening of the piston to push it into the corresponding chamber and thus to increase the pressure in the chamber, so that the located in the chamber Preferably, medium flows into the hollow needle and through it to the foam generator.
  • one of the two pistons is in particular firmly connected to the foam generator. Furthermore, one of the two pistons may also be loosely connected to the foam generator.
  • the medium flows through the piston into the foam generator. Furthermore, it is preferred that the medium from the second chamber through this piston flowing.
  • the two media mix in this preferred embodiment, preferably in the foam generator and / or immediately before the foam generator. It is particularly preferred to push the medium from the chamber further away from the generation of foam through a delivery channel provided in the connecting element and at least partially supply it directly to the foam generator. In this embodiment, a mixing of the two media takes place directly in the foam generator. Possibly.
  • This mixing element may be provided in or in front of the foam generator, a mixing element in which a premixing of the two media takes place before they are pressed by the foam generator.
  • This mixing element may, for example, be a type of sponge or a sintered material which simultaneously serves to decelerate the active substance. As a result, the foam generation is improved.
  • foam generator within the syringe, for example in the batch, e.g. also forms the luer lock to provide.
  • a foam outlet opening of the foam generator can be connected to a foam collecting container.
  • the foam collecting container may be a conventional syringe, which may then be connected to the foam outlet opening, for example via a Luer lock.
  • the device according to the invention is suitable because of its simple and inexpensive construction of preferably individually manufacturable simple parts, especially for disposable use. In particular, due to the disposable use, the required sterility can be ensured. Another advantage of the device according to the invention is that the drug and the gas come into contact with each other only immediately before the application.
  • the device according to the invention for the production of medical foam has an active substance chamber 10 and a gas chamber 12.
  • the active substance chamber 10 is designed as a carpule 14 (FIG. 4) and is sealed with a first piston 16, which may be a rubber stopper or the like.
  • the carpule 14 is held in a holder 18, in which the carpule 14 in the direction of an arrow 20 in the holder 18 in the in Figs. 1 - 3 shown position is inserted.
  • the carpule 14 is in this case fixed by latching elements 22 and with respect to the latching elements 22 arranged stops 24 (FIG. 4) in the position.
  • the holder 18, which receives in the cylindrical opening 26, which preferably also circular cylindrical trained carpule 14 is connected to a cylindrical projection 28. Within the cylindrical projection 28, the gas chamber 12 is formed.
  • the gas chamber 12 is also sealed by a second piston 30.
  • the gas chamber can optionally also be designed as a carpule.
  • the likewise cylindrical gas chamber 12 has a larger diameter than the active substance chamber 10.
  • the provision of active ingredient or gas in the two chambers can also be reversed. This is particularly useful for drugs in which only a small amount of gas is required for foaming, ie in the case of active substances which are already readily foamable themselves.
  • the height of the gas chamber 12 and the active substance chamber 10 is substantially the same, wherein preferably the gas chamber 12 is slightly higher in order to be able to completely empty both chambers 10, 12 if the pistons 16, 30 are fully depressed.
  • the piston 30 is designed as a hollow needle connecting element 32 is connected.
  • the piston 30 has a suitable, for example, cylindrical projection 34 (FIG. 4) into which the hollow needle 32 can be inserted and held, for example, by adhesive bonding.
  • a foam generator 38 fixed or loose and possibly releasably connected.
  • the foam generator 38 has, in particular, two screens 40, which cause a swirling and mixing of the two media and thus the generation of foam.
  • the foam generator 38 is connected via a holder 42 with the piston 30.
  • the foam generator 38 may for example also each have one or more sinter filters, propellers, helices and / or spirals.
  • a loose or detachable connection of the foam generator 38 with the piston 30 has the advantage that the foam generator 38 can be pulled out together with the syringe 46 from the cylindrical projection 38 of the device according to the invention. Upon squeezing the foam out of the syringe 46, it is again forced through the foam generator 38, so that the quality of the foam produced can be further improved. Further, it is possible that on the inside of the cylindrical projection 28 locking elements are provided, is prevented by the fact that the piston 30 can be pulled out of the cylindrical projection 28.
  • the piston 30 may comprise locking elements, for example, in recesses engage, which are provided on the projection 28 when the piston 30 is pulled too far out of the projection 28.
  • the holder 42 has a foam outlet opening 44 (FIG. 4) through which the foam produced in the foam generator 38 emerges.
  • the foam exit port is a luer to which a conventional syringe 46 can be connected.
  • the syringe 46 serves as a foam collecting container, as shown in FIGS. 2 and 3 can be seen.
  • the holder 18 is placed on a base, so that the device, as shown in FIGS. 1-3, is aligned vertically. Subsequently, the syringe body is e.g. by means of the lugs 48 in FIGS. pressed down in the direction of arrow 50. The syringe plunger or syringe plunger 52 is not changed in its position.
  • the foam generator 38 and the second piston 30 is moved downward. Together with the piston 30, the hollow needle 32 firmly connected to the piston 30 is pushed downwards. In this case pierces a tip 54 of the hollow needle 32, the first piston 16 and thus opens the drug chamber 10th
  • a driving element 56 such as a plate is firmly connected, the plate 56 pushes the first piston 16 in the drug chamber 10.
  • the plate 56 pushes the first piston 16 in the drug chamber 10.
  • drug is pressed through the hollow needle 32 into the foam generator 38.
  • gas from the gas chamber 12 is forced into the foam generator 38 through openings 58 located in the piston 30 and / or through transverse bores in the hollow needle 32.
  • the resulting foam passes through the foam outlet opening 44 of the Foam generator 38 in the free by the movement of the syringe body space 60 within the syringe body.
  • a significant advantage of the device according to the invention is that it can be achieved by a single piston stroke, i. that in the Fign. 1 - 3 down-pressing the two pistons 16, 30, a foam in the syringe 46 is generated. After the foam has been produced, the syringe 46 can be released again from the luer adapter, so that subsequently the foam can be applied directly.

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  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

A device for producing medical foam, for example, a sclerosing agent, a diagnostic agent, a therapeutic agent, etc. The device comprises an active ingredient chamber and a gas chamber. Both chambers are respectively closed by a piston and connected to a foam generator. Both pistons are interconnected, especially by a connecting element, and can be displaced together, in order to supply the active ingredient and the gas to the foam producer.

Description

Die Erfindung betrifft eine Vorrichtung zur Erzeugung von insbesondere reproduzierbarem medizinischem Schaum bzw. Bläschensuspension aus einem gasförmigen und einem flüssigen Medium. Insbesondere betrifft die Erfindung eine Mischvorrichtung für die reproduzierbare Zubereitung und Verabreichung von Injektabilia - wie z.B. Verödungsmittel, Diagnostika, Therapeutika, Homöopathika und Eigenblut.The invention relates to a device for producing in particular reproducible medical foam or bubble suspension from a gaseous and a liquid medium. In particular, the invention relates to a mixing device for the reproducible preparation and administration of injectables - such as e.g. Sclerosing agents, diagnostics, therapeutics, homeopathic remedies and autologous blood.

Unter der Verödungstherapie versteht man die planvolle Ausschaltung von intra-, subkutanen und/ oder transfascialen Varizen sowie die Verödung subfascialer Gefäße bei venösen Fehlbildungen durch das Einspritzen eines Verödungsmittels. Die verschiedenen Verödungsmittel führen zu einer Schädigung des Endothels der Gefäße. Im Anschluss kommt es zu einem sekundären Gefäßverschluss und längerfristig zur Umwandlung der Venen in einen bindegewebigen Strang, zur Sklerose. Ziel der Verödungsbehandlung ist die, definitive Umwandlung in einen fibrösen Strang. Dieser kann nicht rekanalisieren und entspricht in seinem funktionellen Ergebnis dem operativen Vorgehen zur Entfernung einer Varize. Neben der Verödung mit flüssigen Sklerosierungsmitteln gewinnt zunehmend die Verödung mit geschäumten Sklerosierungsmitteln an Bedeutung. Der Schaum verbleibt länger in der Vene. Hierbei werden oberflächenaktive Verödungsmittel, wie z.B. Polidocanol, meistens durch Hin- und Herpumpen zwischen zwei Spritzen oder durch Aufschütteln in einen schaumartigen Zustand gebracht und dann konventionell injiziert. Zur Zeit gibt es noch kein zugelassenes Verfahren, das die reproduzierbare Zubereitung eines standardisierten Schaums ermöglicht.Sclerotherapy is the planed elimination of intra-, subcutaneous and / or transfascial varices and the sclerotherapy of subfascial vessels in venous malformations by injecting a sclerosing agent. The various sclerosing agents cause damage to the endothelium of the vessels. This is followed by a secondary vascular occlusion and, in the longer term, the transformation of the veins into a connective tissue strand, to sclerosis. The aim of the sclerotherapy is the definitive transformation into a fibrous strand. This can not recanalize and corresponds in its functional result to the surgical procedure for the removal of a varix. In addition to the sclerotherapy with liquid sclerosizing agents, the sclerotherapy with foamed sclerosants is becoming increasingly important. The foam stays longer in the vein. In this case, surface-active sclerosing agents, such as polidocanol, are usually brought into a foam-like state by reciprocating between two syringes or by shaking and then conventionally injected. At present, there is still no approved process that allows the reproducible preparation of a standardized foam.

Ferner sind zahlreiche als Echokontrastmittel geeignete Zubereitungen bekannt, die z.T. oberflächenaktive Stoffe enthalten, die die Bildung von Mikrobläschen unterstützen und diese stabilisieren. Die Ultraschall reflektierenden Mikrobläschen bzw. ein Schaum sind das eigentliche Kontrastmittel und werden erst unmittelbar vor Verabreichung erzeugt.In addition, numerous preparations suitable as echo contrast agents are known, which are currently available. contain surface-active substances that support the formation of microbubbles and stabilize them. The ultrasound-reflecting microbubbles or a foam are the actual contrast agent and are only generated immediately before administration.

Eine Mischeinrichtung zur Herstellung von medizinischem Schaum bzw. zur Herstellung von Bläschen ist aus EP 0 564 505 bekannt. Hierin ist ein Mischer mit einem wendelförmigen Mischelement beschrieben. Bei dem Mischer handelt es sich um ein Zusatzelement, das mit einer Spritze unlösbar verbunden werden kann. Beim Herausdrücken von flüssigem und/oder gasförmigem Medium aus einer zweiten Spritze gelangt das Medium in den Mischer, welcher das Gas in definiertem Volumen und Art enthält, Hierbei werden Gasphase und Flüssigphase entlang des wendelfömigen Mischelements durchmischt. Hierdurch kann ein therapeutischer und/oder diagnostischer Schaum erzeugt werden.A mixing device for producing medical foam or for producing bubbles is known from EP 0 564 505. Herein is described a mixer with a helical mixing element. The mixer is an additional element that can be permanently connected to a syringe. When expressing liquid and / or gaseous medium from a second syringe, the medium passes into the mixer, which contains the gas in a defined volume and type, Here, gas phase and liquid phase along the helical mixing element are mixed. This can produce a therapeutic and / or diagnostic foam.

Die in EP 0 564 505 beschriebene Mischeinrichtung weist den Nachteil auf, dass der mit der Spritze fest verbundene Mischer, insbesondere beim Hin- und Herbewegen der Lösung, auf Grund des langen Hebels leicht abbrechen oder verkantet werden kann. Ferner handelt es sich bei dem Mischer um ein Bauteil, das auf Grund der in dem Mischer angeordneten spiralförmigen Mischelemente nur mit aufwändigen Spritzgussformen als Spritzgussteil hergestellt werden kann.The mixing device described in EP 0 564 505 has the disadvantage that the mixer, which is firmly connected to the syringe, in particular when the solution is moved back and forth, can easily be broken off or tilted due to the long lever. Furthermore, the mixer is a component which, due to the spiral-shaped mixing elements arranged in the mixer, can only be produced as an injection-molded part using elaborate injection molds.

Eine Doppelkammer Spritze verbunden mit einem Statikmischer die zum Schaum erzeugen geeignet ist, ist in der US-A-3767085 offenbart.A dual chamber syringe connected to a static mixer capable of producing foam is disclosed in US-A-3767085.

Aufgabe der Erfindung ist es, eine Vorrichtung zu schaffen, mit der auf einfache Weise medizinischer Schaum aus einem gasförmigen und einem flüssigen Medium erzeugt werden kann.The object of the invention is to provide a device with which medical foam can be generated from a gaseous and a liquid medium in a simple manner.

Die Lösung der Aufgabe erfolgt erfindungsgemäß durch die Merkmale des Anspruchs 1.The object is achieved according to the invention by the features of claim 1.

Die erfindungsgemäße Vorrichtung weist eine Wirkstoffkammer und eine Gaskammer auf. Beide Kammern sind mit jeweils einem Kolben verschlossen. Ferner weist die Vorrichtung einen Schaumerzeuger, der insbesondere ein oder mehrere Siebe aufweist, auf. Sowohl die Wirkstoffkammer als auch die Gaskammer sind mittelbar oder unmittelbar mit dem Schaumerzeuger verbunden. Erfindungsgemäß sind die beiden Kolben in der jeweiligen Kammer verschiebbar angeordnet. Insbesondere sind die beiden Kolben miteinander verbunden bzw. während des Betätigens der Vorrichtung verbindbar, so dass die beiden Kolben gemeinsam jeweils in einer der beiden Kammern verschoben werden. Hierdurch erfolgt eine Erhöhung des Drucks in den Kammern und somit ein Fördern bzw. Transportieren des Wirkstoffes und des Gases in Richtung des Schaumerzeugers bzw. durch den Schaumerzeuger hindurch. Die erfindungsgemäße Vorrichtung ist somit sehr einfach handhabbar, da durch eine Bewegung beide Kolben bewegt und somit beide Medien in Richtung des Schaumerzeugers gedrückt bzw. transportiert werden. Der aus dem Schaumerzeuger austretende medizinische Schaum muss sodann nur noch aufgefangen werden, kann jedoch auch unmittelbar appliziert werden.The device according to the invention has an active substance chamber and a gas chamber. Both chambers are closed with one piston each. Furthermore, the device has a foam generator, which in particular has one or more screens. Both the drug chamber and the gas chamber are connected directly or indirectly to the foam generator. According to the invention, the two pistons are arranged displaceably in the respective chamber. In particular, the two pistons are connected together or connectable during actuation of the device, so that the two pistons are displaced together in each case in one of the two chambers. This results in an increase in the pressure in the chambers and thus conveying or transporting the active substance and the gas in the direction of the foam generator or through the foam generator therethrough. The device according to the invention is thus very easy to handle, as moved by a movement both pistons and thus both media are pressed or transported in the direction of the foam generator. The emerging from the foam generator medical foam then only needs to be collected, but can also be applied directly.

Bei der erfindungsgemäßen Vorrichtung ist ein Hin- und Herbewegen eines Gases und einer Flüssigkeit bzw. eines Gases und eines Detergens zwischen zwei Spritzen nicht erforderlich. Die Herstellung eines standardisierten sterilen Schaums ist somit erheblich einfacher. Ferner ist das Vorsehen eines Druckgasbehälters bei der erfindungsgemäßen Vorrichtung nicht erforderlich.In the device according to the invention a reciprocation of a gas and a liquid or a gas and a detergent between two syringes is not required. The production of a standardized sterile foam is thus considerably easier. Furthermore, the provision of a compressed gas container in the device according to the invention is not required.

Vorzugsweise sind die beiden Kolben über ein Verbindungselement miteinander verbunden. Das Verbindungselement ist hierbei vorzugsweise derart ausgestaltet, dass beim Verschieben des Verbindungselementes eine der beiden Kammern geöffnet wird. Ferner kann durch das Verschieben des Verbindungselementes ein Verbinden der beiden Kolben erfolgen. Vorzugsweise erfolgt das Verbinden der beiden Kolben erst durch das Betätigen der Vorrichtung. Dies hat den Vorteil, dass die beiden Kammern vollständig voneinander getrennt sind und dicht abgeschlossen werden können. Besonders bevorzugt ist es hierbei, das Verbindungselement als Förderkanal, beispielsweise als Hohlnadel, auszubilden. Durch das Bewegen des Verbindungselements zusammen mit einem der beiden Kolben erfolgt ein Einführen des Verbindungskanals in eine der beiden Kammern. Sofern das Verbindungselement als Hohlnadel ausgebildet ist, erfolgt ein Aufstechen einer der beiden Kammern, indem die Hohlnadel beispielsweise durch den zweiten Kolben hindurch sticht.Preferably, the two pistons are connected to one another via a connecting element. The connecting element is in this case preferably configured such that one of the two chambers is opened during displacement of the connecting element. Furthermore, by moving the Connecting element connecting the two pistons done. Preferably, the connection of the two pistons takes place only by the actuation of the device. This has the advantage that the two chambers are completely separated from each other and can be sealed tightly. It is particularly preferred in this case to form the connecting element as a conveying channel, for example as a hollow needle. By moving the connecting element together with one of the two pistons, the connecting channel is inserted into one of the two chambers. If the connecting element is designed as a hollow needle, piercing one of the two chambers takes place in that the hollow needle pierces, for example, through the second piston.

Besonders bevorzugt ist es, an dem Verbindungselement ein Mitnahmeelement, das insbesondere als Wulst oder Teller ausgebildet sein kann, vorzusehen. Hierdurch ist es möglich, beim Bewegen des Verbindungselements in Richtung eines der beiden die Kammern verschließenden Kolben nach dem beispielsweise Durchstechen bzw. Öffnen des Kolbens diesen in die entsprechende Kammer einzudrücken und somit den Druck in der Kammer zu erhöhen, so dass das in der Kammer befindliche Medium vorzugsweise in die Hohlnadel und durch diese zu dem Schaumerzeuger strömt.It is particularly preferred to provide on the connecting element a driving element, which may be formed in particular as a bead or plate. This makes it possible, when moving the connecting element in the direction of one of the two chambers closing the piston after the example piercing or opening of the piston to push it into the corresponding chamber and thus to increase the pressure in the chamber, so that the located in the chamber Preferably, medium flows into the hollow needle and through it to the foam generator.

Anstelle eines gemeinsamen Verschiebens der beiden Kolben, die vorzugsweise über das Verbindungselement miteinander verbunden sind, ist auch ein Verschieben der beiden Kammern möglich. Relevant ist lediglich die Relativbewegung zwischen den Kammern und den Kolben.Instead of a common displacement of the two pistons, which are preferably connected to one another via the connecting element, a displacement of the two chambers is possible. Only the relative movement between the chambers and the pistons is relevant.

Vorzugsweise ist einer der beiden Kolben mit dem Schaumerzeuger insbesondere fest verbunden. Ferner kann einer der beiden Kolben auch lose mit dem Schaumerzeuger verbunden sein. Vorzugsweise strömt das Medium durch den Kolben hindurch in den Schaumerzeuger. Ferner ist es bevorzugt, dass auch das Medium aus der zweiten Kammer durch diesen Kolben hindurchströmt. Die beiden Medien mischen sich bei dieser bevorzugten Ausführungsform vorzugsweise im Schaumerzeuger und/ oder unmittelbar vor dem Schaumerzeuger. Besonders bevorzugt ist es, das Medium aus der von dem Schaumerzeugung weiter entfernten Kammer durch einen im Verbindungselement vorgesehenen Förderkanal hindurchzudrücken und zumindest teilweise unmittelbar dem Schaumerzeuger zuzuführen. Bei dieser Ausführungsform erfolgt ein Mischen der beiden Medien unmittelbar im Schaumerzeuger. Ggf. kann in oder vor dem Schaumerzeuger ein Mischelement vorgesehen sein, in dem ein Vormischen der beiden Medien erfolgt bevor diese durch den Schaumerzeuger gedrückt werden. Bei diesem Mischelement kann es sich beispielsweise um eine Art Schwämmchen oder ein Sintermaterial handeln, das gleichzeitig zum Abbremsen des Wirkstoffes dient. Hierdurch ist die Schaumerzeugung verbessert.Preferably, one of the two pistons is in particular firmly connected to the foam generator. Furthermore, one of the two pistons may also be loosely connected to the foam generator. Preferably, the medium flows through the piston into the foam generator. Furthermore, it is preferred that the medium from the second chamber through this piston flowing. The two media mix in this preferred embodiment, preferably in the foam generator and / or immediately before the foam generator. It is particularly preferred to push the medium from the chamber further away from the generation of foam through a delivery channel provided in the connecting element and at least partially supply it directly to the foam generator. In this embodiment, a mixing of the two media takes place directly in the foam generator. Possibly. may be provided in or in front of the foam generator, a mixing element in which a premixing of the two media takes place before they are pressed by the foam generator. This mixing element may, for example, be a type of sponge or a sintered material which simultaneously serves to decelerate the active substance. As a result, the foam generation is improved.

Ferner ist es möglich, den Schaumerzeuger innerhalb der Spritze, beispielsweise in dem Ansatz, der z.B. auch den Luer-Lock ausbildet, vorzusehen.Further, it is possible to use the foam generator within the syringe, for example in the batch, e.g. also forms the luer lock to provide.

Vorzugsweise ist eine Schaumaustrittsöffnung des Schaumerzeugers mit einem Schaumauffangbehälter verbindbar. Bei dem Schaumauffangbehälter kann es sich beispielsweise um eine herkömmliche Spritze handeln, die sodann beispielsweise über einen Luer-Lock mit der Schaumaustrittsöffnung verbunden werden kann.Preferably, a foam outlet opening of the foam generator can be connected to a foam collecting container. By way of example, the foam collecting container may be a conventional syringe, which may then be connected to the foam outlet opening, for example via a Luer lock.

Die erfindungsgemäße Vorrichtung ist auf Grund ihres einfachen und kostengünstigen Aufbaus aus vorzugsweise einzeln herstellbaren einfachen Teilen insbesondere für den Einweg-Gebrauch geeignet. Insbesondere auf Grund des Einweg-Gebrauchs kann die erforderliche Sterilität gewährleistet werden. Ein weiterer Vorteil der erfindungsgemäßen Vorrichtung besteht darin, dass das Arzneimittel und das Gas erst unmittelbar vor der Applikation miteinander in Kontakt kommen.The device according to the invention is suitable because of its simple and inexpensive construction of preferably individually manufacturable simple parts, especially for disposable use. In particular, due to the disposable use, the required sterility can be ensured. Another advantage of the device according to the invention is that the drug and the gas come into contact with each other only immediately before the application.

Nachfolgend wird die Erfindung anhand einer bevorzugten Ausführungsform unter Bezugnahme auf die anliegenden Zeichnungen näher erläutert.The invention will be explained in more detail with reference to a preferred embodiment with reference to the accompanying drawings.

Es zeigen:

Fig. 1 - 3
eine schematische, teilweise geschnittene Seitenansicht der Vorrichtung in drei unterschiedlichen Mischzuständen und
Fig.4
eine schematische Explosionszeichnung der erfindungsgemäßen Vorrichtung.
Show it:
Fig. 1-3
a schematic, partially sectioned side view of the device in three different mixed states and
Figure 4
a schematic exploded view of the device according to the invention.

Die erfindungsgemäße Vorrichtung zur Erzeugung von medizinischem Schaum weist eine Wirkstoffkammer 10 und eine Gaskammer 12 auf. Die Wirkstoffkammer 10 ist als Carpule 14 (Fig. 4) ausgebildet und mit einem ersten Kolben 16, bei dem es sich um einen Gummistopfen oder dgl. handeln kann, dicht verschlossen. Die Carpule 14 wird in einer Halterung 18 gehalten, in dem die Carpule 14 in Richtung eines Pfeils 20 in die Halterung 18 in die in den Fign. 1 - 3 dargestellte Lage eingeschoben wird. Die Carpule 14 wird hierbei durch Rastelemente 22 und gegenüber den Rastelementen 22 angeordneten Anschlägen 24 (Fig. 4) in der Lage fixiert. Die Halterung 18, die in der zylindrischen Öffnung 26, die vorzugsweise ebenfalls kreiszylindrisch ausgebildete Carpule 14 aufnimmt, ist mit einem zylindrischen Ansatz 28 verbunden. Innerhalb des zylindrischen Ansatzes 28 ist die Gaskammer 12 ausgebildet.The device according to the invention for the production of medical foam has an active substance chamber 10 and a gas chamber 12. The active substance chamber 10 is designed as a carpule 14 (FIG. 4) and is sealed with a first piston 16, which may be a rubber stopper or the like. The carpule 14 is held in a holder 18, in which the carpule 14 in the direction of an arrow 20 in the holder 18 in the in Figs. 1 - 3 shown position is inserted. The carpule 14 is in this case fixed by latching elements 22 and with respect to the latching elements 22 arranged stops 24 (FIG. 4) in the position. The holder 18, which receives in the cylindrical opening 26, which preferably also circular cylindrical trained carpule 14 is connected to a cylindrical projection 28. Within the cylindrical projection 28, the gas chamber 12 is formed.

Die Gaskammer 12 ist durch einen zweiten Kolben 30 ebenfalls dicht verschlossen. Die Gaskammer kann wahlweise auch als Carpule ausgebildet sein. Die ebenfalls zylindrisch ausgebildete Gaskammer 12 weist einen größeren Durchmesser als die Wirkstoffkammer 10 auf. Selbstverständlich kann das Vorsehen von Wirkstoff bzw. Gas in den beiden Kammern auch vertauscht werden. Dies ist insbesondere bei Wirkstoffen zweckmäßig, bei denen nur eine geringe Menge an Gas zum Aufschäumen erforderlich ist, d.h. bei Wirkstoffen, die bereits selbst leicht schäumbar sind. Die Höhe der Gaskammer 12 sowie der Wirkstoffkammer 10 ist im Wesentlichen gleich, wobei vorzugsweise die Gaskammer 12 geringfügig höher ist, um bei vollständig eingedrückten Kolben 16, 30 beide Kammern 10, 12 ggf. vollständig entleeren zu können.The gas chamber 12 is also sealed by a second piston 30. The gas chamber can optionally also be designed as a carpule. The likewise cylindrical gas chamber 12 has a larger diameter than the active substance chamber 10. Of course, the provision of active ingredient or gas in the two chambers can also be reversed. This is particularly useful for drugs in which only a small amount of gas is required for foaming, ie in the case of active substances which are already readily foamable themselves. The height of the gas chamber 12 and the active substance chamber 10 is substantially the same, wherein preferably the gas chamber 12 is slightly higher in order to be able to completely empty both chambers 10, 12 if the pistons 16, 30 are fully depressed.

Mit dem zweiten Kolben 30 ist ein als Hohlnadel ausgebildetes Verbindungselement 32 verbunden. Hierzu weist der Kolben 30 einen geeigneten, beispielsweise zylindrischen Ansatz 34 (Fig. 4) auf, in den die Hohlnadel 32 einsteckbar und beispielsweise durch Verkleben gehalten ist.With the second piston 30 is designed as a hollow needle connecting element 32 is connected. For this purpose, the piston 30 has a suitable, for example, cylindrical projection 34 (FIG. 4) into which the hollow needle 32 can be inserted and held, for example, by adhesive bonding.

Ferner ist mit dem Kolben 30, der an der Innenwandung 36 der Gaskammer 12 abdichtend anliegt, ein Schaumerzeuger 38 fest oder lose und ggf. lösbar verbunden. Der Schaumerzeuger 38 weist insbesondere zwei Siebe 40 auf, die ein Verwirbeln und Vermischen der beiden Medien und somit das Erzeugen von Schaum hervorrufen. Der Schaumerzeuger 38 ist über eine Halterung 42 mit dem Kolben 30 verbunden.Further, with the piston 30, which bears sealingly against the inner wall 36 of the gas chamber 12, a foam generator 38 fixed or loose and possibly releasably connected. The foam generator 38 has, in particular, two screens 40, which cause a swirling and mixing of the two media and thus the generation of foam. The foam generator 38 is connected via a holder 42 with the piston 30.

Zusätzlich oder anstatt eines oder mehrerer Siebe kann der Schaumerzeuger 38 beispielsweise auch jeweils einen oder mehrere Sinteifilter, Propeller, Wendeln und/ oder Spiralen aufweisen.In addition to or instead of one or more screens, the foam generator 38 may for example also each have one or more sinter filters, propellers, helices and / or spirals.

Ein loses bzw. lösbares Verbinden des Schaumerzeugers 38 mit dem Kolben 30 hat den Vorteil, dass der Schaumerzeuger 38 zusammen mit der Spritze 46 aus dem zylindrischen Ansatz 38 der erfindungsgemäßen Vorrichtung herausgezogen werden kann. Beim Herausdrücken des Schaums aus der Spritze 46 wird diese erneut durch den Schaumerzeuger 38 gedrückt, so dass die Qualität des hergestellten Schaums weiter verbessert werden kann. Ferner ist es möglich, dass an der Innenseite des zylindrischen Ansatzes 28 Rastelemente vorgesehen sind, durch die verhindert ist, dass der Kolben 30 aus dem zylindrischen Ansatz 28 herausgezogen werden kann. Ebenso kann der Kolben 30 Rastelemente aufweisen, die beispielsweise in Ausnehmungen einrasten, die an dem Ansatz 28 vorgesehen sind, wenn der Kolben 30 zu weit aus dem Ansatz 28 herausgezogen wird.A loose or detachable connection of the foam generator 38 with the piston 30 has the advantage that the foam generator 38 can be pulled out together with the syringe 46 from the cylindrical projection 38 of the device according to the invention. Upon squeezing the foam out of the syringe 46, it is again forced through the foam generator 38, so that the quality of the foam produced can be further improved. Further, it is possible that on the inside of the cylindrical projection 28 locking elements are provided, is prevented by the fact that the piston 30 can be pulled out of the cylindrical projection 28. Likewise, the piston 30 may comprise locking elements, for example, in recesses engage, which are provided on the projection 28 when the piston 30 is pulled too far out of the projection 28.

Die Halterung 42 weist eine Schaumaustrittsöffnung 44 (Fig. 4) auf, durch die der in dem Schaumerzeuger 38 erzeugte Schaum austritt. In dem dargestellten besonders bevorzugten Ausführungsbeispiel der Erfindung handelt es sich bei der Schaumaustrittsöffnung um einen Luer, mit dem eine herkömmliche Spritze 46 verbunden werden kann. Die Spritze 46 dient hierbei als Schaumauffangbehälter, wie anhand der Fign. 2 und 3 ersichtlich.The holder 42 has a foam outlet opening 44 (FIG. 4) through which the foam produced in the foam generator 38 emerges. In the illustrated particularly preferred embodiment of the invention, the foam exit port is a luer to which a conventional syringe 46 can be connected. The syringe 46 serves as a foam collecting container, as shown in FIGS. 2 and 3 can be seen.

Zur Herstellung von Schaum wird die Halterung 18 auf eine Unterlage gestellt, so dass die Vorrichtung, wie in den Fign. 1 - 3 dargestellt, vertikal ausgerichtet ist. Anschließend wird der Spritzenkörper z.B. mit Hilfe der Ansätze 48 in den Fign. nach unten in Richtung eines Pfeils 50 gedrückt. Der Spritzenkolben oder Spritzenstempel 52 wird hierbei in seiner Lage nicht verändert. Durch die Verschiebung des Spritzenkörpers nach unten in die Halterung 28 hinein wird insbesondere der Schaumerzeuger 38 sowie der zweite Kolben 30 nach unten verschoben. Zusammen mit dem Kolben 30 wird die mit dem Kolben 30 fest verbundene Hohlnadel 32 nach unten geschoben. Hierbei durchstößt eine Spitze 54 der Hohlnadel 32 den ersten Kolben 16 und öffnet somit die Wirkstoffkammer 10.For the production of foam, the holder 18 is placed on a base, so that the device, as shown in FIGS. 1-3, is aligned vertically. Subsequently, the syringe body is e.g. by means of the lugs 48 in FIGS. pressed down in the direction of arrow 50. The syringe plunger or syringe plunger 52 is not changed in its position. By the displacement of the syringe body down into the holder 28 in particular, the foam generator 38 and the second piston 30 is moved downward. Together with the piston 30, the hollow needle 32 firmly connected to the piston 30 is pushed downwards. In this case pierces a tip 54 of the hollow needle 32, the first piston 16 and thus opens the drug chamber 10th

Da mit dem Verbindungselement bzw. der Hohlnadel 32 ein Mitnahmeelement 56, wie ein Teller, fest verbunden ist, drückt der Teller 56 den ersten Kolben 16 in die Wirkstoffkammer 10. Durch die Verschiebung der beiden Kolben 30, 16 erfolgt sowohl eine Druckerhöhung in der Wirkstoffkammer 10 als auch in der Gaskammer 12. Hierdurch wird Wirkstoff durch die Hohlnadel 32 in den Schaumerzeuger 38 gedrückt. Ferner wird Gas aus der Gaskammer 12 durch Öffnungen 58, die sich in dem Kolben 30 befinden und/oder durch Querbohrungen in der Hohlnadel 32, in den Schaumerzeuger 38 gedrückt. Der hierbei entstehende Schaum gelangt durch die Schaumaustrittsöffnung 44 des Schaumerzeugers 38 in den durch die Bewegung des Spritzenkörpers frei werden Raum 60 innerhalb des Spritzenkörpers.Since with the connecting element or the hollow needle 32, a driving element 56, such as a plate is firmly connected, the plate 56 pushes the first piston 16 in the drug chamber 10. By the displacement of the two pistons 30, 16, both an increase in pressure in the drug chamber 10 as well as in the gas chamber 12. As a result, drug is pressed through the hollow needle 32 into the foam generator 38. Further, gas from the gas chamber 12 is forced into the foam generator 38 through openings 58 located in the piston 30 and / or through transverse bores in the hollow needle 32. The resulting foam passes through the foam outlet opening 44 of the Foam generator 38 in the free by the movement of the syringe body space 60 within the syringe body.

Ein wesentlicher Vorteil der erfindungsgemäßen Vorrichtung besteht darin, dass durch einen einmaligen Kolbenhub, d.h. das in den Fign. 1 - 3 nachunten-Drücken der beiden Kolben 16, 30 ein Schaum in der Spritze 46 erzeugt wird. Die Spritze 46 kann nach Erzeugen des Schaums wieder von dem Luer-Adapter gelöst werden, so dass anschließend der Schaum unmittelbar appliziert werden kann.A significant advantage of the device according to the invention is that it can be achieved by a single piston stroke, i. that in the Fign. 1 - 3 down-pressing the two pistons 16, 30, a foam in the syringe 46 is generated. After the foam has been produced, the syringe 46 can be released again from the luer adapter, so that subsequently the foam can be applied directly.

Claims (10)

  1. Device for producing medicinal foam, comprising:
    an active agent chamber (10) closed with a first piston (16),
    a gas chamber (12) closed with a second piston (30), and
    a foam producing means (38) connected with the active agent chamber (10) and the gas chamber (12),

    wherein both pistons (16, 30) may be interconnected and displaced in common to feed the active agent and the gas to the foam producing means (38)
    characterized in that
    the two pistons (16, 30) are interconnected through a connecting element (32) which opens one of the chambers (10) when it is displaced.
  2. Device of claim 1, wherein the connecting element (32) comprises a feed channel through which the active agent and/or the gas can flow towards the foam producing means (38).
  3. Device of claim 1 or 2, wherein the connecting element (32) comprises an entrainment element (56) for entraining one of the two pistons (16).
  4. Device of one of claims 1 - 3, wherein the feed channel connects the chamber (10) opened by the connecting element (32) immediately with the foam producing means (38) and/or the other chamber (12).
  5. Device of one of claims 1 - 4, wherein the chambers (10, 12) adjoin each other.
  6. Device of one of claims 1 - 5, wherein one of the two pistons (16, 30) is in particular rigidly connected to the foam producing means (38).
  7. Device of one of claims 1 - 6, wherein the foam producing means (38) has a foam exit opening (44) connectable to a foam collecting vessel (46) or an application aid.
  8. Device of one of claims 1-7, wherein the foam producing means (38) includes at least one, preferably at least two sieves (40) for producing foam.
  9. Device of one of claims 1 - 8, wherein a slow-down element is provided that is arranged upstream of the foam producing means (38) to cause, in particular, a slowing of the active agent and thus a pre-mixing of the active agent and the gas.
  10. Device of one of claims 1 - 9, wherein the connecting element (32) has openings for the active agent and/or the gas to exit from the feed channel of the connecting element (32) into a chamber (12).
EP03795826.1A 2002-11-28 2003-11-13 Device for producing medical foam Expired - Lifetime EP1572336B2 (en)

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DE20218493U DE20218493U1 (en) 2002-11-28 2002-11-28 Device for producing medical foam
DE20218493U 2002-11-28
PCT/EP2003/012894 WO2004047969A1 (en) 2002-11-28 2003-11-13 Device for producing medical foam

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EP1572336B1 true EP1572336B1 (en) 2006-03-15
EP1572336B2 EP1572336B2 (en) 2018-01-24

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EP (1) EP1572336B2 (en)
AT (1) ATE320304T1 (en)
AU (1) AU2003298123A1 (en)
DE (2) DE20218493U1 (en)
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WO (1) WO2004047969A1 (en)

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US7963938B2 (en) 2011-06-21
DE20218493U1 (en) 2004-04-08
WO2004047969A1 (en) 2004-06-10
AU2003298123A1 (en) 2004-06-18
US20060178620A1 (en) 2006-08-10
DE50302685D1 (en) 2006-05-11
ES2260686T3 (en) 2006-11-01
ATE320304T1 (en) 2006-04-15
EP1572336A1 (en) 2005-09-14
EP1572336B2 (en) 2018-01-24

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