EP1572336B2 - Device for producing medical foam - Google Patents
Device for producing medical foam Download PDFInfo
- Publication number
- EP1572336B2 EP1572336B2 EP03795826.1A EP03795826A EP1572336B2 EP 1572336 B2 EP1572336 B2 EP 1572336B2 EP 03795826 A EP03795826 A EP 03795826A EP 1572336 B2 EP1572336 B2 EP 1572336B2
- Authority
- EP
- European Patent Office
- Prior art keywords
- foam
- chamber
- connecting element
- pistons
- gas
- 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.)
- Expired - Lifetime
Links
- 239000006260 foam Substances 0.000 title claims abstract description 76
- 239000013543 active substance Substances 0.000 claims description 15
- 238000011144 upstream manufacturing Methods 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 9
- 239000003229 sclerosing agent Substances 0.000 abstract description 6
- 239000004480 active ingredient Substances 0.000 abstract description 4
- 239000000032 diagnostic agent Substances 0.000 abstract 1
- 229940039227 diagnostic agent Drugs 0.000 abstract 1
- 229940124597 therapeutic agent Drugs 0.000 abstract 1
- 229940079593 drug Drugs 0.000 description 7
- 239000007788 liquid Substances 0.000 description 5
- 238000007632 sclerotherapy Methods 0.000 description 5
- 238000006073 displacement reaction Methods 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
- 238000002360 preparation method Methods 0.000 description 3
- 206010046996 Varicose vein Diseases 0.000 description 2
- 230000009466 transformation Effects 0.000 description 2
- 208000027185 varicose disease Diseases 0.000 description 2
- 210000003462 vein Anatomy 0.000 description 2
- 229920001363 Polidocanol Polymers 0.000 description 1
- 208000034189 Sclerosis Diseases 0.000 description 1
- 206010053648 Vascular occlusion Diseases 0.000 description 1
- 238000004026 adhesive bonding Methods 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 239000011324 bead Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 210000002808 connective tissue Anatomy 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 239000002872 contrast media Substances 0.000 description 1
- 230000000881 depressing effect Effects 0.000 description 1
- 230000000994 depressogenic effect Effects 0.000 description 1
- 239000003599 detergent Substances 0.000 description 1
- -1 diagnostics Substances 0.000 description 1
- 239000002961 echo contrast media Substances 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 210000003038 endothelium Anatomy 0.000 description 1
- 238000005187 foaming Methods 0.000 description 1
- 230000001632 homeopathic effect Effects 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 239000007791 liquid phase Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000012071 phase Substances 0.000 description 1
- ONJQDTZCDSESIW-UHFFFAOYSA-N polidocanol Chemical compound CCCCCCCCCCCCOCCOCCOCCOCCOCCOCCOCCOCCOCCO ONJQDTZCDSESIW-UHFFFAOYSA-N 0.000 description 1
- 229960002226 polidocanol Drugs 0.000 description 1
- 238000005086 pumping Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 208000021331 vascular occlusion disease Diseases 0.000 description 1
- 201000009371 venous hemangioma Diseases 0.000 description 1
Images
Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F33/00—Other mixers; Mixing plants; Combinations of mixers
- B01F33/50—Movable or transportable mixing devices or plants
- B01F33/501—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
- B01F33/5011—Movable 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F25/00—Flow mixers; Mixers for falling materials, e.g. solid particles
- B01F25/30—Injector mixers
- B01F25/31—Injector mixers in conduits or tubes through which the main component flows
- B01F25/311—Injector mixers in conduits or tubes through which the main component flows for mixing more than two components; Devices specially adapted for generating foam
- B01F25/3111—Devices specially adapted for generating foam, e.g. air foam
- B01F25/31112—Devices specially adapted for generating foam, e.g. air foam with additional mixing means other than injector mixers, e.g. screen or baffles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F25/00—Flow mixers; Mixers for falling materials, e.g. solid particles
- B01F25/40—Static mixers
- B01F25/45—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads
- B01F25/451—Mixers 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F25/00—Flow mixers; Mixers for falling materials, e.g. solid particles
- B01F25/40—Static mixers
- B01F25/45—Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads
- B01F25/452—Mixers 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
- B01F25/4522—Mixers 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
- B01F25/45221—Mixers 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.
- surfactant sclerosing agents e.g. Polidocanol
- surfactant sclerosing agents usually by pumping back and forth between two syringes or by shaking in a foam-like state and then injected conventionally.
- a mixing device for the production of medical foam or for the production of bubbles is out EP 0 564 505 known.
- the mixer 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 mixer In the EP 0 564 505 described mixing device has the disadvantage that the mixer firmly connected to the syringe, especially when reciprocating the solution, due to the long lever can easily break off or be tilted. 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 expensive injection molds.
- a double chamber syringe connected to a static mixer which is suitable for generating foam is disclosed in US Pat US-A-3767085 disclosed.
- 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. According to the invention, the two pistons are connected to each other 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 designed such that when moving the connecting element one of the two chambers is opened. Further, by moving the connecting element, a connection of the two pistons take place. 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 inventively provided to form the connecting element as a hollow needle. By moving the connecting element together with one of the two pistons, the hollow needle is inserted into one of the two chambers. There is a piercing one of the two chambers by the hollow needle pierces, for example, through the second piston.
- a driving element which may be formed in particular as a bead or plate provided.
- 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 also flows through this piston.
- 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 ingredient chamber 10 is called carpule 14 (FIG. Fig. 4 ) and 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 the FIGS. 1 - 3 shown position is inserted.
- the carpule 14 is in this case by latching elements 22 and opposite the latching elements 22 arranged stops 24 (FIG. Fig. 4 fixed in 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 with drugs where only a small amount of gas is required for foaming, i. 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 ), in which the hollow needle 32 can be inserted and held, for example by gluing.
- 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. Likewise, the piston 30 may have locking elements which engage, for example, in recesses provided on the lug 28 when the piston 30 is pulled too far out of the lug 28.
- the holder 42 has a foam outlet opening 44 (FIG. 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 based on the FIGS. 2 and 3 seen.
- the holder 18 is placed on a base, so that the device, as in the FIGS. 1 - 3 shown, is vertically aligned. Subsequently, the syringe body, for example, by means of the approaches 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 by a single piston stroke, ie in the FIGS. 1 - 3 depressing the two pistons 16, 30, a foam is generated in the syringe 46. 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.
Landscapes
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dispersion Chemistry (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Materials For Medical Uses (AREA)
Abstract
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. Here, surfactant sclerosing agents, e.g. Polidocanol, usually by pumping back and forth between two syringes or by shaking in a foam-like state and then injected conventionally. 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
Die in
Eine Doppelkammer Spritze verbunden mit einem Statikmischer die zum Schaum erzeugen geeignet ist, ist in der
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. Erfindungsgemäß 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. According to the invention, the two pistons are connected to each other 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.
Erfindungsgemäß sind die beiden Kolben über ein Verbindungselement miteinander verbunden. Das Verbindungselement ist hierbei 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. Es ist erfindungsgemäß vorgesehen, das Verbindungselement als Hohlnadel auszubilden. Durch das Bewegen des Verbindungselements zusammen mit einem der beiden Kolben erfolgt ein Einführen der Hohlnadel in eine der beiden Kammern. Es erfolgt ein Aufstechen einer der beiden Kammern, indem die Hohlnadel beispielsweise durch den zweiten Kolben hindurch sticht.According to the invention, the two pistons are connected to one another via a connecting element. The connecting element is in this case designed such that when moving the connecting element one of the two chambers is opened. Further, by moving the connecting element, a connection of the two pistons take place. 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 inventively provided to form the connecting element as a hollow needle. By moving the connecting element together with one of the two pistons, the hollow needle is inserted into one of the two chambers. There is a piercing one of the two chambers by the hollow needle pierces, for example, through the second piston.
Weiterhin erfindungsgemäß vorgesehen 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.Furthermore, it is provided according to the invention, on the connecting element, a driving element, which may be formed in particular as a bead or plate provided. This makes it possible, upon movement of the connecting element in the direction of one of the two chambers closing the piston after the example piercing or opening the piston to push this into the appropriate chamber and thus to increase the pressure in the chamber, so that the in-chamber Preferably, medium flows into the hollow needle and through it to the foam generator.
Anstelle eines gemeinsamen Verschiebens der beiden Kolben, die 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 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 also flows through this piston. 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.
- 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 (
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
Mit dem zweiten Kolben 30 ist ein als Hohlnadel ausgebildetes Verbindungselement 32 verbunden. Hierzu weist der Kolben 30 einen geeigneten, beispielsweise zylindrischen Ansatz 34 (
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
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
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
Die Halterung 42 weist eine Schaumaustrittsöffnung 44 (
Zur Herstellung von Schaum wird die Halterung 18 auf eine Unterlage gestellt, so dass die Vorrichtung, wie in den
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
Ein wesentlicher Vorteil der erfindungsgemäßen Vorrichtung besteht darin, dass durch einen einmaligen Kolbenhub, d.h. das in den
Claims (10)
- 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), anda 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 thatthe two pistons (16, 30) are interconnected through a connecting element (32) which opens one of the chambers (10) when it is displaced,the connecting element (32) comprises an entrainment element (56) for entraining one of the two pistons (16), andwherein the connecting element (32) is configured as a hollow needle, so that a puncturing of one of the two chambers (10, 12) is performed by the hollow needle (32) piercing through one of the pistons (16).
- 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).
- Device of claim 1 or 2, wherein the connecting element (32) comprises an entrainment element (56) for entraining one of the two pistons (16).
- 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).
- Device of one of claims 1 - 4, wherein the chambers (10, 12) adjoin each other.
- 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).
- 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.
- 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.
- 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.
- 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).
Applications Claiming Priority (3)
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DE20218493U | 2002-11-28 | ||
DE20218493U DE20218493U1 (en) | 2002-11-28 | 2002-11-28 | Device for producing medical foam |
PCT/EP2003/012894 WO2004047969A1 (en) | 2002-11-28 | 2003-11-13 | Device for producing medical foam |
Publications (3)
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EP1572336A1 EP1572336A1 (en) | 2005-09-14 |
EP1572336B1 EP1572336B1 (en) | 2006-03-15 |
EP1572336B2 true EP1572336B2 (en) | 2018-01-24 |
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EP03795826.1A Expired - Lifetime EP1572336B2 (en) | 2002-11-28 | 2003-11-13 | Device for producing medical foam |
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US (1) | US7963938B2 (en) |
EP (1) | EP1572336B2 (en) |
AT (1) | ATE320304T1 (en) |
AU (1) | AU2003298123A1 (en) |
DE (2) | DE20218493U1 (en) |
ES (1) | ES2260686T3 (en) |
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DE50302685D1 (en) | 2006-05-11 |
WO2004047969A1 (en) | 2004-06-10 |
AU2003298123A1 (en) | 2004-06-18 |
US7963938B2 (en) | 2011-06-21 |
US20060178620A1 (en) | 2006-08-10 |
EP1572336B1 (en) | 2006-03-15 |
ES2260686T3 (en) | 2006-11-01 |
DE20218493U1 (en) | 2004-04-08 |
ATE320304T1 (en) | 2006-04-15 |
EP1572336A1 (en) | 2005-09-14 |
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