EP1572336B2 - Dispositif permettant de produire une mousse medicale - Google Patents

Dispositif permettant de produire une mousse medicale Download PDF

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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
Application number
EP03795826.1A
Other languages
German (de)
English (en)
Other versions
EP1572336B1 (fr
EP1572336A1 (fr
Inventor
Jan-Christoph Wollmann
Dorothee Schliephake
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Chemische Fabrik Kreussler and Co GmbH
Original Assignee
Chemische Fabrik Kreussler and Co GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
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Application filed by Chemische Fabrik Kreussler and Co GmbH filed Critical Chemische Fabrik Kreussler and Co GmbH
Publication of EP1572336A1 publication Critical patent/EP1572336A1/fr
Publication of EP1572336B1 publication Critical patent/EP1572336B1/fr
Application granted granted Critical
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Classifications

    • 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
    • B01F25/30Injector 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
    • 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.
  • 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.

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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)

Claims (10)

  1. Dispositif de production d'une mousse médicale, avec
    une chambre à principe actif (10) fermée par un premier piston (16),
    une chambre à gaz (12) fermée par un deuxième piston (30) et
    un générateur de mousse (38) raccordé sur la chambre à principe actif (10) et sur la chambre à gaz (12),
    les deux pistons (16, 30) étant reliés entre eux et mobiles ensemble, pour transporter du principe actif et du gaz vers le générateur de mousse (38),
    caractérisé en ce que
    les deux pistons (16, 30) sont reliés entre eux par l'intermédiaire d'un élément de liaison (32) qui, lorsqu'il se déplace, ouvre l'une des deux chambres (10),
    l'élément de liaison (32) comporte un élément d'entraînement (56) pour entraîner l'un des deux pistons (16), et
    l'élément de liaison (32) est en forme d'une aiguille creuse de sorte qu'une des deux chambres (10, 12) est percée par l'aiguille creuse (32) perçant un des pistons (16).
  2. Dispositif selon la revendication 1, caractérisé en ce que l'élément de liaison (32) comporte une canalisation de transport à travers laquelle le principe actif et/ou le gaz peut s'écouler en direction du générateur de mousse (38).
  3. Dispositif selon la revendication 1 ou 2, caractérisé en ce que l'élément de liaison (32) comporte un élément d'entraînement (56) pour entraîner l'un des deux pistons (16).
  4. Dispositif selon l'une quelconque des revendications 1 à 3, caractérisé en ce que la canalisation de transport relie directement la chambre (10) ouverte par l'élément de liaison (32) avec le générateur de mousse (38) et/ou avec l'autre chambre (12).
  5. Dispositif selon l'une quelconque des revendications 1 à 4, caractérisé en ce que les chambres (10, 12) sont adjacentes.
  6. Dispositif selon l'une quelconque des revendications 1 à 5, caractérisé en ce que l'un des deux pistons (16, 30) est relié au générateur de mousse (38) de façon particulièrement fixe.
  7. Dispositif selon l'une quelconque des revendications 1 à 6, caractérisé en ce que le générateur de mousse (38) comporte un orifice de sortie de mousse (44) pouvant être relié avec un récipient collecteur de mousse (46) ou avec un applicateur.
  8. Dispositif selon l'une quelconque des revendications 1 à 7, caractérisé en ce que le générateur de mousse (38) comporte au moins un, de préférence au moins deux cribles (40) pour la génération de mousse.
  9. Dispositif selon l'une quelconque des revendications 1 à 8, caractérisé par un élément de freinage, qui est monté en amont du générateur de mousse (38), pour assurer notamment un freinage du principe actif et donc un mélange préalable du principe actif et du gaz.
  10. Dispositif selon l'une quelconque des revendications 1 à 9, caractérisé en ce que l'élément de liaison (32) comporte des orifices pour la sortie du principe actif et/ou du gaz hors de la canalisation de transport de l'élément de liaison (32) vers une chambre (12).
EP03795826.1A 2002-11-28 2003-11-13 Dispositif permettant de produire une mousse medicale Expired - Lifetime EP1572336B2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE20218493U 2002-11-28
DE20218493U DE20218493U1 (de) 2002-11-28 2002-11-28 Vorrichtung zur Erzeugung von medizinischem Schaum
PCT/EP2003/012894 WO2004047969A1 (fr) 2002-11-28 2003-11-13 Dispositif permettant de produire une mousse medicale

Publications (3)

Publication Number Publication Date
EP1572336A1 EP1572336A1 (fr) 2005-09-14
EP1572336B1 EP1572336B1 (fr) 2006-03-15
EP1572336B2 true EP1572336B2 (fr) 2018-01-24

Family

ID=32103522

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03795826.1A Expired - Lifetime EP1572336B2 (fr) 2002-11-28 2003-11-13 Dispositif permettant de produire une mousse medicale

Country Status (7)

Country Link
US (1) US7963938B2 (fr)
EP (1) EP1572336B2 (fr)
AT (1) ATE320304T1 (fr)
AU (1) AU2003298123A1 (fr)
DE (2) DE20218493U1 (fr)
ES (1) ES2260686T3 (fr)
WO (1) WO2004047969A1 (fr)

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US9662435B2 (en) 2006-01-31 2017-05-30 Frank Levy System and method for the effective, reliable and foolproof delivery of controlled amounts of a medical fluid
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US8876749B2 (en) 2006-11-27 2014-11-04 Frank Levy Apparatus and process for producing CO2 enriched medical foam
US11833320B2 (en) 2006-11-27 2023-12-05 Frank Levy Apparatus and process for producing CO2 enriched medical foam
US11185671B2 (en) 2006-11-27 2021-11-30 Frank Levy Apparatus and process for producing CO2 enriched medical foam
US11712510B2 (en) 2006-11-27 2023-08-01 Frank Levy Delivery system and method for the effective, reliable and foolproof delivery of controlled amounts of a medical fluid
US10322271B2 (en) 2006-11-27 2019-06-18 Frank Levy Delivery system and method for the effective and reliable delivery of controlled amounts of a medical fluid
US10149935B2 (en) 2006-11-27 2018-12-11 Frank Levy Delivery system and method for the effective and reliable delivery of controlled amounts of a medical fluid
US10350399B2 (en) 2006-11-27 2019-07-16 Frank Levy Apparatus and method for producing an enriched medical suspension of carbon dioxide
US10155093B2 (en) 2006-11-27 2018-12-18 Frank Levy Apparatus and method for producing CO2 enriched medical foam
US9427522B2 (en) 2006-11-27 2016-08-30 Frank Levy Delivery system for the effective and reliable delivery of controlled amounts of a medical fluid
US10070888B2 (en) * 2008-10-03 2018-09-11 Femasys, Inc. Methods and devices for sonographic imaging
US9554826B2 (en) 2008-10-03 2017-01-31 Femasys, Inc. Contrast agent injection system for sonographic imaging
CA2678198A1 (fr) * 2009-09-08 2011-03-08 Duoject Medical Systems Inc. Dispositif de liaison facile pour transfer de fluide
US8449494B2 (en) * 2009-12-16 2013-05-28 Cook Medical Technologies Llc Apparatus and method for preparing foam
EP2508219B1 (fr) * 2011-04-05 2018-06-06 Kpr U.S., Llc Mise en mémoire tampon de système d'administration d'un agent pour seringue anesthésique
GB201612948D0 (en) * 2016-07-26 2016-09-07 Provensis Ltd syringe for administering foam
RU2659632C1 (ru) * 2017-04-04 2018-07-03 Федеральное государственное бюджетное образовательное учреждение высшего образования "Рязанский государственный медицинский университет имени академика И.П. Павлова" Министерства здравоохранения Российской Федерации Устройство для вспенивания и введения лекарственного препарата
CN107096406B (zh) * 2017-05-11 2023-09-15 金宝医学科技(深圳)有限公司 一种微泡沫生成装置及方法
WO2019233546A1 (fr) * 2018-06-04 2019-12-12 Gemü Gmbh Applicateur
CN111013423B (zh) * 2020-01-06 2024-06-14 中国人民解放军陆军军医大学第一附属医院 发泡装置

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EP1572336B1 (fr) 2006-03-15
DE20218493U1 (de) 2004-04-08
ES2260686T3 (es) 2006-11-01
US20060178620A1 (en) 2006-08-10
ATE320304T1 (de) 2006-04-15
EP1572336A1 (fr) 2005-09-14
US7963938B2 (en) 2011-06-21
WO2004047969A1 (fr) 2004-06-10
AU2003298123A1 (en) 2004-06-18
DE50302685D1 (de) 2006-05-11

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