WO2014033287A1 - Dispositif de test permettant l'apport d'une substance dans un milieu - Google Patents

Dispositif de test permettant l'apport d'une substance dans un milieu Download PDF

Info

Publication number
WO2014033287A1
WO2014033287A1 PCT/EP2013/068040 EP2013068040W WO2014033287A1 WO 2014033287 A1 WO2014033287 A1 WO 2014033287A1 EP 2013068040 W EP2013068040 W EP 2013068040W WO 2014033287 A1 WO2014033287 A1 WO 2014033287A1
Authority
WO
WIPO (PCT)
Prior art keywords
substance
medium
test device
chamber
test
Prior art date
Application number
PCT/EP2013/068040
Other languages
German (de)
English (en)
Inventor
Stefan Henke
Karsten Heuser
Heiko Spilgies
Original Assignee
Lts Lohmann Therapie-Systeme Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lts Lohmann Therapie-Systeme Ag filed Critical Lts Lohmann Therapie-Systeme Ag
Priority to BR112015004078A priority Critical patent/BR112015004078B1/pt
Priority to JP2015529036A priority patent/JP6437436B2/ja
Priority to EP13771402.8A priority patent/EP2890967A1/fr
Priority to CA2883034A priority patent/CA2883034A1/fr
Priority to CN201380054269.1A priority patent/CN104736992A/zh
Publication of WO2014033287A1 publication Critical patent/WO2014033287A1/fr
Priority to HK15107638.6A priority patent/HK1207153A1/xx

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N11/00—Investigating flow properties of materials, e.g. viscosity, plasticity; Analysing materials by determining flow properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M2005/3142—Modular constructions, e.g. supplied in separate pieces to be assembled by end-user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • A61M5/3007—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules with specially designed jet passages at the injector's distal end

Definitions

  • Test device for dispensing a substance into a medium
  • the invention relates to a test device for delivering a substance into a medium, comprising
  • a chamber for receiving a substance having a closed end and a nozzle arranged therein
  • the invention relates to an associated test method including use of the test device for carrying out a test method.
  • test devices relate to devices described in the prior art.
  • the Applicant has e.g. DE 10 2008 063 519 A1, DE 10 2007 004 21 1 A1, DE 10 2007 018 868 A1 or DE 10 2007 032 464 A1 describes suitable devices for dispensing a substance into a medium.
  • the device is variable in its components, so that an optimization of the delivery of a substance can be done in a medium.
  • the invention is therefore based on the object to provide a test device, which is handy and easily accessible to replace individual components quickly and safely. This object is achieved in that a test device according to claim 1 is provided.
  • Subsequent components can be variably exchanged and combined with one another, wherein optionally at least one component can be varied:
  • the front closed end of the chamber has at least one nozzle, multi-hole systems, i. a larger number of nozzles are known, described e.g. in DE 20 2008 017 814 U1, paragraph 0050.
  • cannula sections can also be inserted into the nozzle bores or, instead of the nozzle bores, directly molded cannulas, mini needles or the like can be provided.
  • the front closed end of the chamber can also have a curved or other spatial shape instead of a flat surface described in the applications (see above on "spring drive"), as described, for example, in WO 2009/097966 A1 or DE 10 2004 007 257 A1.
  • the chamber volume can be varied from 0.1 ml to about 2.0 ml, taking into account different internal diameters of the chamber and consequently the size of the bearing surface of the front closed end of the chamber.
  • the material of the chamber can be changed.
  • the chamber can be made of plastic, glass, metal, ceramic, etc.
  • the surface in the chamber can be subjected to a treatment, for example, to influence the adhesion of the substance.
  • the nozzle diameter varies between 0.1 and 1.5 mm, described e.g. in DE10 2005 054 600 A1 paragraph 0030, DE 10 2006 045 959 B3 paragraph 0030 or DE 10 2007 031 630 B3 paragraph 0054.
  • the arrangement and orientation of the nozzles may vary such that the beam direction is both longitudinal and off-axis, e.g. in DE 20 2008 017 814 U1 (paragraph 0043 ff).
  • the plunger to accommodate in the chamber may vary in size and material. Also, the piston distance from the stamp is selectable. The piston diameter can be adapted to the chamber volume, both in shape as well as in length and in width. In particular, the density and the friction of the piston on the chamber wall are freely selectable.
  • the punch can be varied in length and in the centering and adapted to the piston surface.
  • variable components or “one or more components may be varied”
  • variable components may be interconnected by conventional fasteners (e.g., screws, etc.). Fixed components can be seen in FIG.
  • the materials used can be made from a transparent material (eg glass, plastics).
  • a transparent material eg glass, plastics
  • the sleeve for receiving the spring drive of a transparent material exist (see Fig. 3, 2).
  • the chamber can be made transparent, so that piston processes can be observed and visually evaluated.
  • the test device advantageously permits the determination of a pressure / time diagram as a function of the selected substance / medium combination, which is e.g. Characteristic is shown in Fig. 4. Furthermore interested are sizes such as chamber pressure, piston / punch speed, heating, stability, exit velocity, piston deformation, chamber tightness, etc., so that the qualitative suitability of a selected test device depending on the varied components can be closed or optimized.
  • “substance” means one or more different or the same chemical compounds
  • the substance may also contain a plurality of substances
  • the substance may be a functionally defined substance, such as a biosimiliar, artificial or native substance, inorganic or organic compound, pure substance,
  • the substance may be solid, liquid, semisolid, semi-liquid and, if appropriate, present in a solution.Also, the substance may comprise any additives and auxiliaries or solvents, such as those used in galenics.
  • test procedure e.g. be provided that the substance is used in a dilution series.
  • medium means a receptive medium having any elasticity or mass, in particular those such as native or artificial tissue, gels (ultrasound gel, silicone gel), pig skin.
  • the medium can also be, for example, a sensor for determining the exit velocity of the substance from the nozzle (s) and / or the exit force Suitable measuring instruments, such as pressure cans, etc., are known to the person skilled in the art.
  • the medium is transparent, so that the penetration depth and distribution of a substance in the medium can be visualized.
  • the medium can be mechanically stabilized, for example by means of a container, preferably of transparent material (plastic, glass or the like).
  • the medium may contain an attachment which establishes a mechanical connection to the test device so that a standardization of the test procedure is possible.
  • the person skilled in the art is able to provide corresponding attachments or holders.
  • variable components may be provided in a kit or kit with or without a test device including media and / or attachment.
  • Another object of the invention relates to a test method for delivering the substance into a medium using a test device according to the invention.
  • the invention therefore relates to a test method in which a test device is equipped with a (test) substance and the release of the substance into the medium is checked on the basis of the medium, depending on the variable components.
  • the test allows a result with statements in particular to the penetration depth of the substance into a medium as well as distribution of the substance in the medium.
  • the invention relates to a test method, wherein a test device according to the invention is equipped with a substance and is dispensed into a medium and the result is read out.
  • the reading may be visual or photographic, and the data captured (e.g., computer, database, etc.).
  • the data e.g., computer, database, etc.
  • the creation of a database allows comparative investigations.
  • conventional measuring instruments can be installed on the test device.
  • the invention relates to an iterative test method wherein, with replacement of the variable components or modification of the substance (eg Replacement, additives) a certain result is optimized / improved and the test procedure is repeated if necessary.
  • replacement of the variable components or modification of the substance eg Replacement, additives
  • the result e.g., a certain depth of penetration in a medium
  • the result may be optimized or adjusted (e.g., distribution of a substance in a medium).
  • the invention also relates to a test method wherein the depth of penetration into the medium depends on substance properties (eg density, viscosity, etc.), and chamber properties (eg volume, nozzle shape or nozzle shapes, diameter of nozzles, Chamber material such as plastic, glass, metal, ceramic and the surface) is tested.
  • substance properties eg density, viscosity, etc.
  • chamber properties eg volume, nozzle shape or nozzle shapes, diameter of nozzles, Chamber material such as plastic, glass, metal, ceramic and the surface
  • Another object of the invention relates to the use of a test device according to the invention for screening a substance for delivery in a medium.
  • the invention relates to the use of a test device according to the invention for simulating the delivery of a substance into a medium.
  • the screening or the simulation can preferably be achieved by carrying out the test method according to the invention.
  • the invention thus provides that, in a preferred embodiment, for further influencing the distance of the lower end of the actuating device to the back of the piston is formed changeable.
  • the actuating device is both held in a holder and guided. Since, in a drive with a tensioned spring, the spring acts on the actuator, e.g. releasable hook provided in the holder, wherein the hook release by means of a triggering device release the tensioned spring, which then accelerates the actuator and transported to the piston.
  • Fig. 1 and Fig. 2 show a front view of a test device with the individual variable components.
  • Fig. 1 the test device 1 according to the invention can be seen. From a rear wall 2 protrudes at right angles from a first holding element 3 for receiving a chamber 4.
  • the chamber 4 receives a substance 5, which can escape through a nozzle 6 at the closed end 7 of the chamber 4.
  • the nozzle 6 is located on the longitudinal axis 8 of the chamber 4.
  • a piston 10 is placed on the medium 5 at the opposite open end 9 of the chamber 4, through which the chamber 4 is closed with the medium therein.
  • the piston 10 has to be moved along the longitudinal axis 8 from the open end 9 of the chamber 4 to the closed end 7.
  • the piston 10 is acted upon by an actuating device 1 1 and accelerated in the direction of the closed end 7 with the nozzle 6.
  • the medium 5 located in the chamber 4 is pushed out of the chamber 4 through the nozzle 6.
  • the force required for the expression is provided by a drive 12, which is directly in contact with the upper end 13 of the actuator 1 1 while the lower end 14 of the actuator 14 is spaced from the back 15 of the piston 10.
  • a spring 16 is taken into account in a first embodiment.
  • a spring 16 comprehensive tube can be provided or an inner guide pin.
  • an explosion drive (not shown) or a gas drive (not shown) can likewise be introduced into a drive holder 17.
  • an explosion drive or a gas drive the complete unit of the drive 12 must be replaced.
  • the spring 16 When using a spring 16, it is possible to adjust the spring force of a selected spring 16 such that the spring 16 by means of a propulsion 17 in the form of a spindle or a stroke adjustment to a specific Dimension is compressed before triggering occurs. Therefore, the spring 16 can be used multiple times while the spring force can be adjusted.
  • the spring rate can be adjusted. This happens because the upper end of the spring 16 is accelerated after release by a further drive in the direction of the nozzle 6.
  • the propulsion system 17 is accelerated downwards in the direction of the chamber 4 by a further drive device, so that the spring 16 can not completely relax but continues to be subjected to a force.
  • FIG. 2 shows a further embodiment of the test device, the features 9, 10, 11 and 12 being structurally fixed (fixed components), and the features 1, 2, 3, 4, 5 and 6 being able to be varied.
  • the variation of the features allows an optimization of the test device with regard to the substance to be considered as a function of the medium.
  • FIG. 3 shows an exemplary fixed test device comprising at least one measuring instrument 1, a transparent sleeve 2 for receiving a spring drive, a medium 3 together with an infeeding chamber 4 containing a nozzle.
  • time / pressure diagram for carrying out the test experiments on the basis of the test device.
  • the time / pressure diagram may vary using the variable components.

Landscapes

  • General Health & Medical Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Investigating Strength Of Materials By Application Of Mechanical Stress (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Abstract

L'invention concerne un dispositif de test permettant l'apport d'une substance dans un milieu et comprenant : - une chambre destinée à recevoir une substance et présentant une extrémité fermée dans laquelle est agencée une buse ; - un piston servant à fermer une extrémité ouverte de la chambre ; - un dispositif d'actionnement ; - et un entraînement. Un ou plusieurs de ces éléments peuvent être modifiés : a) l'extrémité fermée (7) de la chambre (4) est configurée pour pouvoir être munie de différentes buses (6) interchangeables ; b) l'écart entre l'extrémité inférieure (14) du dispositif d'actionnement (11) et la face arrière (15) du piston (10) peut être modifié ; c)on utilise divers entraînements (12) ; la chambre (4) est produite à partir de différents matériaux et/ou dans différentes dimensions. L'invention concerne par ailleurs un procédé de test associé et l'utilisation du dispositif de test pour la mise en œuvre d'un procédé de test.
PCT/EP2013/068040 2012-08-30 2013-08-30 Dispositif de test permettant l'apport d'une substance dans un milieu WO2014033287A1 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
BR112015004078A BR112015004078B1 (pt) 2012-08-30 2013-08-30 dispositivo de teste para dispensar uma substância em um meio
JP2015529036A JP6437436B2 (ja) 2012-08-30 2013-08-30 物質を媒体の中に投入するための試験デバイス
EP13771402.8A EP2890967A1 (fr) 2012-08-30 2013-08-30 Dispositif de test permettant l'apport d'une substance dans un milieu
CA2883034A CA2883034A1 (fr) 2012-08-30 2013-08-30 Dispositif de test permettant l'apport d'une substance dans un milieu
CN201380054269.1A CN104736992A (zh) 2012-08-30 2013-08-30 用于将物质配送到介质中的测试装置
HK15107638.6A HK1207153A1 (en) 2012-08-30 2015-08-07 Test device for dispensing a substance into a medium

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP12182358 2012-08-30
EP12182358.7 2012-08-30

Publications (1)

Publication Number Publication Date
WO2014033287A1 true WO2014033287A1 (fr) 2014-03-06

Family

ID=46801334

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2013/068040 WO2014033287A1 (fr) 2012-08-30 2013-08-30 Dispositif de test permettant l'apport d'une substance dans un milieu

Country Status (7)

Country Link
EP (1) EP2890967A1 (fr)
JP (2) JP6437436B2 (fr)
CN (1) CN104736992A (fr)
BR (1) BR112015004078B1 (fr)
CA (1) CA2883034A1 (fr)
HK (1) HK1207153A1 (fr)
WO (1) WO2014033287A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014033287A1 (fr) * 2012-08-30 2014-03-06 Lts Lohmann Therapie-Systeme Ag Dispositif de test permettant l'apport d'une substance dans un milieu

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5697917A (en) * 1996-02-29 1997-12-16 Medi-Ject Corporation Nozzle assembly with adjustable plunger travel gap
WO2007140610A1 (fr) * 2006-06-07 2007-12-13 Acushot Inc. Mécanisme de chargement pour injecteur sans aiguille
US20090030367A1 (en) * 2007-07-27 2009-01-29 Allergan, Inc. Soft tissue augmentation by needle-free injection
WO2011051365A2 (fr) * 2009-10-30 2011-05-05 Sanofi-Aventis Deutschland Gmbh Dispositifs d'administration de médicament et leur procédé d'assemblage
WO2013169946A1 (fr) * 2012-05-09 2013-11-14 Bioject Inc. Performances d'injection sans aiguille conformément à des relations connues

Family Cites Families (14)

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Publication number Priority date Publication date Assignee Title
JPS4910152Y1 (fr) * 1968-06-18 1974-03-11
US4335760A (en) * 1980-10-06 1982-06-22 E. R. Squibb & Sons, Inc. Apparatus for holding a syringe and filling an ampule
US5062830A (en) * 1990-04-04 1991-11-05 Derata Corporation Dry disposable nozzle assembly for medical jet injector
CN1164195A (zh) * 1994-11-19 1997-11-05 韦斯顿医疗有限公司 适用于无针注射器内的医用玻璃容器
GB9425642D0 (en) * 1994-12-20 1995-02-22 Weston Medical Ltd Filling device
GB9607549D0 (en) * 1996-04-11 1996-06-12 Weston Medical Ltd Spring-powered dispensing device
GB9818110D0 (en) * 1998-08-19 1998-10-14 Weston Medical Ltd Needleless injectors and other devices
JP2002177389A (ja) * 2000-12-08 2002-06-25 Eisuke Fujimoto 無針注射器
CN200998469Y (zh) * 2007-02-02 2008-01-02 曾沂水 输液自动呼叫器
DE102007031630B3 (de) * 2007-07-06 2008-12-24 Lts Lohmann Therapie-Systeme Ag Einweginjektor mit mindestens einem Stützstab
DE102007032463A1 (de) * 2007-07-10 2009-01-15 Lts Lohmann Therapie-Systeme Ag Einweginjektor mit mindestens einem zwangsentkoppelbaren Zughaken
CN201131986Y (zh) * 2007-10-29 2008-10-15 冯少为 电动无针注射器
CN102125712B (zh) * 2010-01-14 2013-09-18 北京快舒尔医疗技术有限公司 预装药品的无针注射器
WO2014033287A1 (fr) * 2012-08-30 2014-03-06 Lts Lohmann Therapie-Systeme Ag Dispositif de test permettant l'apport d'une substance dans un milieu

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5697917A (en) * 1996-02-29 1997-12-16 Medi-Ject Corporation Nozzle assembly with adjustable plunger travel gap
WO2007140610A1 (fr) * 2006-06-07 2007-12-13 Acushot Inc. Mécanisme de chargement pour injecteur sans aiguille
US20090030367A1 (en) * 2007-07-27 2009-01-29 Allergan, Inc. Soft tissue augmentation by needle-free injection
WO2011051365A2 (fr) * 2009-10-30 2011-05-05 Sanofi-Aventis Deutschland Gmbh Dispositifs d'administration de médicament et leur procédé d'assemblage
WO2013169946A1 (fr) * 2012-05-09 2013-11-14 Bioject Inc. Performances d'injection sans aiguille conformément à des relations connues

Also Published As

Publication number Publication date
CN104736992A (zh) 2015-06-24
CA2883034A1 (fr) 2014-03-06
EP2890967A1 (fr) 2015-07-08
BR112015004078B1 (pt) 2020-05-05
JP6633141B2 (ja) 2020-01-22
JP2015528570A (ja) 2015-09-28
JP6437436B2 (ja) 2018-12-12
JP2018185318A (ja) 2018-11-22
BR112015004078A2 (pt) 2017-07-04
HK1207153A1 (en) 2016-01-22

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