JP2015528570A - Test device for loading a substance into a medium - Google Patents

Abstract

The present invention includes a chamber for receiving a substance having a closed end and a nozzle disposed therein, a piston for closing the open end of the chamber, an actuating device, and a drive device. Is a test device for introducing one or more components into a medium, wherein one or more components can be modified: a) the closed end (7) of the chamber (4) 6) provided to be interchangeable; b) the distance of the lower end (14) of the actuating device (11) from the back (15) of the piston (10) can be changed C) various drive units (12) are used; d) the chamber (4) relates to a test device made of various materials and / or various dimensions. The invention further relates to a related test method and the use of a test device for performing the test method.

Description

The present invention
A chamber for receiving a substance having a closed end and a nozzle arranged therein;
-A piston for closing the open end of the chamber;
-An actuating device;
A test device for introducing a substance into the medium, including a drive; The invention further relates to a related test method and the use of a test device for performing the test method.

  The test device relates to the device described in the prior art. The applicant describes, for example, in Patent Document 1, Patent Document 2, Patent Document 3 or Patent Document 4, an appropriate device for introducing a substance into a medium.

  For example, in the service relationship, testing of such a device is strongly required in terms of introducing a substance into the medium. The test makes it possible to optimize the input of the substance into the medium. It is important that the device be changeable with respect to its components so that the input of the substance into the medium can be optimized.

  In the prior art, no conclusion can be reached using the physical and chemical properties of a substance with regard to the suitability of said substance for loading the substance from the device into the medium. Therefore, a systematic test for changes in materials and components within the test device is required.

DE102008063519A1 DE102007004211A1 DE102007018868A1 DE102007032464A1

  It is an object of the present invention to enable use of a test device that is easy to handle and use so that individual components can be replaced quickly and safely.

  According to the invention, this object is achieved by enabling the test device according to claim 1.

  Embodiments of the invention are described in the dependent claims and are described below.

  The following components can be interchanged and combined in various ways, and in some cases at least one component can be changed:

Drive device:
A spring drive as described, for example, in the applicant's patent applications DE102008063519A1, DE102007004211A1, DE102007018868A1, or DE102007032464A1.
A gas-type driving device as described, for example, in EP1125593B1 or EP12432281B1.
A pyrotechnic drive as described, for example, in EP 1292344B1.

Chamber:
The closed end in front of the chamber has at least one nozzle, and a very large number of nozzles are known, ie described in paragraph 0050 of eg DE 202008017814U1. Alternatively, the cannula portion can be fitted into the nozzle hole, or a directly formed cannula, small needle, etc. can be provided instead of the nozzle hole.
-Instead of the flat surface described in each application (see the above-mentioned "spring-driven drive" section), the closed end in front of the chamber, for example as described in WO2009 / 097966A1 or DE102004007257A1 The part can also have a curved shape or other three-dimensional shape.
The chamber volume can be varied from 0.1 ml to about 2.0 ml, taking into account the various inner diameters of the chamber and hence the size of the support surface at the front end of the chamber.
-Furthermore, the material of the chamber can be changed. For example, the chamber can be made of plastic, glass, metal, ceramic, and the like. The surface of the chamber can also be treated, for example, to affect material deposition.

nozzle:
The diameter of the nozzle varies between 0.1 and 1.5 mm and is described, for example, in paragraph 0030 of DE1020050454600A1, paragraph 0030 of DE102006045959B3, or paragraph 0054 of DE102007031630B3.
The arrangement and orientation of the nozzles is changed so that the spray liquid is directed along the longitudinal axis and deviates from the longitudinal axis, for example as described in DE 202008017814U1 (paragraph 0043ff) can do.

piston:
-The pistons received in the chamber may vary in size and material. Similarly, the distance of the piston from the ram can be selected. The diameter of the piston can be adapted to the volume of the chamber, both in shape and in length and width. In particular, the tightness and friction against the chamber wall of the piston can be chosen freely.

Ram or actuating device:
-The length and centering of the ram can be changed and adapted to the surface of the piston.
(In the following, “changeable components” or “one or more components can be changed”.)

  The changeable components can be connected to each other by conventional fastening elements (eg screws). The fixed structural element can be seen in FIG.

  In order to better observe the test process, the materials used can be made from transparent materials (eg glass, plastic). For example, the sleeve for receiving the spring-type drive can be made of a transparent material (see 2 in FIG. 3). In addition, the chamber can be transparent so that the piston process can be observed and visually evaluated.

  The test device according to the invention advantageously makes it possible to determine, for example, the pressure / time graph characteristic of FIG. 4 depending on the selected substance / medium combination. Other important parameters that can determine and optimize the qualitative suitability of the selected test device according to various components are: chamber pressure, piston / ram speed, heating, stability Performance, output speed, piston deformation, chamber tightness, etc.

  In the context of the present invention, “substance” means one or more different or identical chemical compounds. A substance can also include multiple substances. The substance can be a functionally defined substance, such as a biosimilar, an artificial or natural substance, an inorganic or organic compound, a pure substance, a natural substance, a pharmaceutical, an active substance, a generic substance, etc. . Further, the substance can be a solid, liquid, semi-solid, semi-liquid, and can be present as a solution if appropriate. In addition, the materials can include any desired additives and auxiliaries or solvents, such as used in, for example, galenical formulations.

  To carry out the test method, for example, the substance can be used as a dilution series.

  In addition, color enhancers or dyes can be added to the material for better visualization.

  In the context of the present invention, “medium” means an absorption having any desired elasticity or bulk, in particular natural or artificial tissue, gels (ultrasonic gel, silicone gel), pig skin, etc. Means sex medium.

  In addition, color enhancers or dyes can be added to the media for better visualization. However, the “medium” can also be a sensor, for example, to determine the rate at which the substance exits the nozzle (s) and / or the exiting force. The person skilled in the art knows suitable measuring instruments such as pressure transducers.

  The medium is preferably transparent so that the penetration depth and distribution of the substance in the medium can be presented visually. In particular, the medium can be mechanically stabilized, for example by a container preferably made of a transparent material (plastic, glass, etc.).

  The medium can include a fixture that establishes a mechanical connection to the test device to allow standardization of the test method. One skilled in the art can provide a suitable fixture or holder.

  The changeable components can be made available in the form of a modular system or kit with or without test devices and media and / or fixtures.

  The invention further relates to a test method for introducing a 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 filled with a (test) substance and the medium is used to examine the input of the substance into the medium depending on the changeable components.

  By examining it, it is possible to obtain a result that also concludes in particular about the penetration depth of the substance into the medium and the distribution of the substance in the medium.

  In a preferred embodiment, the present invention relates to a test method in which a test device according to the present invention is filled with a substance, the substance is put into a medium and the result is read.

  In other embodiments, reading can be done visually or by photography and data can be recorded (eg, computer, database, etc.). By providing a database, it is possible to check by comparison. In addition, normal measuring equipment can be attached to the test device.

  In particular, the present invention optimizes / improves the determined results by changeable component exchange or substance change (eg, exchange, additive), and repeats the test method if appropriate. Relating to a typical test method.

  Alternatively, an (electronic) calibration curve can optimize or adapt the results (eg, penetration depth determined in the media) (eg, distribution of substances in the media) ).

  Thus, the present invention also applies to material properties (eg, density, viscosity, etc.) and chamber properties (eg, volume, nozzle shape (s), nozzle diameter, chamber material (plastic, It relates to a test method for determining the penetration depth into a medium according to glass, metal, ceramic, etc.) and surface).

  The invention further relates to the use of a test device according to the invention for screening substances to be introduced into a medium. In particular, the invention relates to the use of a test device according to the invention for simulating the loading of a substance into a medium. Screening or simulation can preferably be performed by carrying out the test method according to the invention.

  Therefore, in a preferred embodiment of the invention, the distance from the back of the piston at the lower end of the actuating device is provided such that it can be changed. For this purpose, for example, the actuating device is held and guided in a holder. In the case of a drive using a spring under pressure, since the spring acts on the actuating device, for example a releasable hook is provided on the holder, in which case the hook is triggered by a trigger device. To allow the spring under pressure to be released, thereby accelerating the actuating device and moving the actuating device over the piston.

  Other features and details of the invention are set forth in the following description of the exemplary embodiments of the invention shown in the claims and in schematic form.

1 is a front view of a test device having individual changeable components. FIG. 1 is a front view of a test device having individual changeable components. FIG. FIG. 2 shows an example of a fixed test device comprising at least one measuring instrument 1, a transparent sleeve 2 for receiving a spring-loaded drive, a medium 3 and a supply chamber 4 including a nozzle. Figure 2 is a characteristic time / pressure graph for performing a test using a test device;

  A test device 1 according to the invention can be seen in FIG. A first holding element 3 for receiving the chamber 4 protrudes from the back wall 2 at a right angle. The chamber 4 receives a substance 5 which can exit through a nozzle 6 at the closed end 7 of the chamber 4. The nozzle 6 is on the longitudinal axis 8 of the chamber 4. In the extension of the longitudinal axis 8, at the open end 9 opposite the chamber 4, a piston 10 is applied to the substance 5 and closes the chamber 4 with the substance inside.

  In order to carry the substance 5 out of the chamber 4, the piston 10 must be moved along the longitudinal axis 8 from the open end 9 of the chamber 4 to the closed end 7. For this purpose, the actuating device 11 acts on the piston 10 and accelerates the piston 10 in the direction of the closed end 7 with the nozzle 6. The substance 5 in the chamber 4 is pushed out of the chamber 4 through the nozzle 6. The force necessary to do this is supplied by the drive 12 in direct contact with the upper end 13 of the actuation device 11, while the lower end 14 of the actuation device 11 is a distance from the back surface 15 of the piston 10. Located at.

  In the first embodiment, a spring 16 is provided as the driving device 12. In order to prevent the spring 16 from buckling, it is possible to provide a tube surrounding the spring 16 or a guide pin arranged inside.

  As the drive device 12, a pyrotechnic drive device (not shown) or a gas drive device (not shown) can be introduced into the drive holder 17 instead of the spring 16. When using a pyrotechnic drive or gas drive, the entire unit of drive 12 must be replaced.

  When the spring 16 is used, the spring force of the selected spring 16 is compressed by a thrust mechanism 17 in the form of a spindle or stroke adjusting means to a predetermined range before triggering takes place. It is possible to adjust. Thus, the spring 16 can be used multiple times and the spring force is adjusted in the process.

  In other embodiments, the spring rate can be further adjusted. This is done by the upper end of the spring 16 which is accelerated in the direction of the nozzle 6 by another drive after triggering has taken place. For this purpose, for example, the thrust mechanism 17 is accelerated downwards in the direction of the chamber 4 by another drive device so that the spring 16 cannot be relaxed completely and is still subjected to forces.

  FIG. 2 shows a test device in which the features 9, 10, 11 and 12 are structurally fixed (fixed structural elements) and the mechanisms 1, 2, 3, 4, 5 and 6 can be modified. Other embodiments are shown. By changing the mechanism, it is possible to optimize the test device for the relevant substances depending on the medium.

  FIG. 3 shows an example of a fixed test device consisting of at least one measuring instrument 1, a transparent sleeve 2 for receiving a spring drive, a medium 3 and a supply chamber 4 containing a nozzle.

  FIG. 4 shows a characteristic time / pressure graph for performing a test using a test device. Depending on the media and material, the time / pressure graph may change with components that can be changed.

FIG.
DESCRIPTION OF SYMBOLS 1 Test device 2 Back wall 3 1st holding element 4 Chamber 5 Substance 6 Nozzle 7 Closed end of chamber 4 Longitudinal axis 9 Open end of chamber 4 10 Piston 11 Actuating device 12 Driving device 13 Actuation Upper end of device 11 14 Lower end of actuation device 11 15 Back of piston 10 16 Spring 17 Thrust mechanism FIG. 2
DESCRIPTION OF SYMBOLS 1 Drive device 2 Fixing means / trigger 3 Piston distance 4 Piston 5 Chamber 6 Nozzle (shape)
7 Chamber diameter 8 Chamber volume 9 Chamber fastening 10 Holder / connector / drive chamber 11 Ram 12 Sleeve FIG.
1 Measuring instrument 2 Sleeve (transparent)
3 Medium 4 Chamber

Claims (14)

A chamber (4) for receiving a substance (5), having a closed end (7) and a nozzle (6) disposed therein;
A piston (10) for closing the open end (9) of the chamber (4);
A test device (1) for introducing a substance into a medium, comprising an actuating device (11) and a drive (12), one or more components can be modified:
a) The closed end (7) of the chamber (4) is provided so that it can be replaced with various nozzles (6); and / or b) the lower end (14) of the actuation device (11) ) Of the piston (10) from the back surface (15) is provided to be variable; and / or c) various drive devices (12) are used; and / or d) the chamber (4 ) Made of different materials and / or different dimensions.   2. Test device according to claim 1, characterized in that the drive device (12) comprises a) a spring (16), b) a gas cartridge, or c) a pyrotechnic drive device.   The test device according to claim 2, wherein the spring force is adjustable.   The test device according to claim 2, wherein the spring constant is adjustable.   Test device according to claim 1, characterized in that the distance between the lower end (14) of the actuating device (11) and the back surface (15) of the piston (10) is measured optically. .   One or more different or identical chemical compounds, in particular biosimilars, man-made or natural substances, inorganic or organic compounds, pure substances, natural substances, pharmaceuticals, active substances, generics, especially if appropriate 2. The test device according to claim 1, comprising a substance selected from the group comprising solid, liquid, semi-solid, semi-liquid substances in the form of solutions or solvents, additives and auxiliaries.   A kit or modular system comprising the test device and media of claim 1, as appropriate, with a fixture.   Kit or modular system, characterized in that the medium is preferably selected from the group comprising transparent, natural or artificial tissue, gel (ultrasonic gel, silicone gel), pig skin .   A test characterized in that the test device according to any one of claims 1 to 8 is filled with a substance, and the medium is used to examine the input of the substance into the medium according to the changeable components. Method.   10. The test method according to claim 9, wherein results are read, in particular results relating to the penetration depth of the substance into the medium and the distribution of the substance in the medium.   10. A test method according to claim 9, wherein the reading is performed visually or by photography, and where appropriate, the data is recorded in particular by a database.   The test method according to claim 9, wherein the test method is repeatedly performed.   Use of a test device according to any one of claims 1 to 12 for screening substances to be introduced into a medium.   Use of a test device according to any one of the preceding claims for simulating the loading of a substance into a medium.

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