JP6633141B2 - Test device for injecting substances into media - Google Patents

Description

The present invention
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 actuation device;
A test device for introducing a substance into a medium, including a drive. The invention further relates to related test methods and to the use of test devices for performing the test methods.

  Test devices relate to the devices described in the prior art. Applicants have described suitable devices for injecting a substance into a medium, for example, in US Pat.

  For example, in the context of services, there is a strong demand for testing such devices in injecting substances into media. Testing allows to optimize the introduction of the substance into the medium. It is important that the device can be modified with respect to its components so that the introduction 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 regarding the suitability of said substance for injecting it from a device into a medium. Therefore, there is a need for a systematic test for changes in materials and components within the test device.

DE 102008063519A1 DE102007004211A1 DE 102007018868A1 DE 102007032464A1

  It is an object of the present invention to make available 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 a test device according to claim 1.

  Embodiments of the invention are set out 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 modified:

Drive:
-For example, patent applications DE102008063519A1, DE102007 by the applicant
A spring drive as described in 004211 A1, DE 10207018868 A1 or DE 102007032464 A1.
A gas drive as described, for example, in EP 1 125 593 B1 or EP 1 243 281 B1.
A pyrotechnic drive as described, for example, in EP 1 292 344 B1.

Chamber:
The front closed end of the chamber has at least one nozzle, and a multiplicity of nozzles is known, i.e. a large number of nozzles, for example as described in paragraph 0050 of DE202008017814U1. Alternatively, the cannula portion can be fitted into the nozzle hole or, instead of the nozzle hole, a directly formed cannula, small needle or the like can be provided.
-Instead of the flat surface described in each application (see the section "Spring driven device" above), the front closed end of the chamber, for example as described in WO 2009/099766 A1, or DE 102004007257A1 The sections can also have a curved or other three-dimensional shape.
The volume of the chamber can be varied from 0.1 ml to about 2.0 ml, taking into account the different inner diameters of the chamber and thus the size of the support surface at the front closed end of the chamber.
Further, the material of the chamber can be changed. For example, the chamber can be made of plastic, glass, metal, ceramic, and the like. For example, the surface of the chamber can be treated to affect the deposition of material.

nozzle:
The nozzle diameter varies between 0.1 and 1.5 mm and is described, for example, in DE 10 2005 054 600 A1, paragraph 0030, DE 102006045959 B3, paragraph 0030 or DE 102007031630B3, paragraph 0054.
The arrangement and orientation of the nozzles is changed such that the spray liquid is directed along the longitudinal axis and also deviates from the longitudinal axis, as described, for example, in DE202008017814U1 (paragraph 0043ff) can do.

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

Ram or actuation device:
-The length and centering of the ram can be changed and adapted to the surface of the piston.
(Hereinafter, "modifiable components" or "one or more components can be modified.")

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

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 drive can be made of a transparent material (see FIG. 3B). In addition, the chamber can be transparent so that the process of the piston can be observed and evaluated visually.

  The test device according to the invention advantageously makes it possible, for example, to determine the pressure / time graph characteristic of FIG. 4 as a function of the selected substance / medium combination. Other important parameters that allow the qualitative suitability of the selected test device to be determined and optimized for various components include chamber pressure, piston / ram speed, heating, and 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 a plurality of substances. The substance can be a functionally defined substance, such as biosimilar, man-made or intact substance, inorganic or organic compound, pure substance, natural substance, medicine, active substance, generic, etc. . Further, the substance can be solid, liquid, semi-solid, semi-liquid and, where appropriate, present as a solution. In addition, the substance can include any desired additives, such as those used in galenical formulations, and auxiliaries or solvents.

  To carry out the test method, for example, the substances 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, "vehicle" refers to any desired elastic or bulky absorbent, such as intact or artificial tissue, gel (ultrasonic gel, silicone gel), pig skin, etc. Means sexual media.

  In addition, color enhancers or dyes can be added to the media for better visualization. However, the "medium" can be a sensor, for example, to determine the rate at which a substance exits the nozzle (s) and / or the force at which it exits. Suitable measuring instruments such as pressure transducers are known to a person skilled in the art.

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

  The media may include a fixture that establishes a mechanical connection to the test device so that test methods can be standardized. One skilled in the art can provide a suitable fixture or holder.

  The modifiable components may be enabled in a modular system or kit, with or without test devices and media and / or fixtures.

  The present invention further relates to a test method for injecting a substance into a medium using a test device according to the present invention.

  The invention therefore relates to a test method in which the test device is filled with a (test) substance and the medium is used to determine the introduction of the substance into the medium according to the modifiable components.

  The examination gives in particular results on the depth of penetration of the substance into the medium and also on the distribution of the substance in the medium.

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

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

  In particular, the present invention optimizes / improves the determined results by changing components that can be changed, or by changing materials (eg, replacement, additives) and, if appropriate, repeating the test method. Test method.

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

  Thus, the present invention also provides material properties (eg, density, viscosity, etc.) and chamber properties (eg, volume, nozzle shape (s), nozzle diameter, chamber material (plastic, Glass, metal, ceramic, etc.) and surface).

  The invention furthermore 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 introduction of a substance into a medium. Screening or simulation can preferably be performed by performing the test method according to the invention.

  Thus, in a preferred embodiment of the invention, the distance of the lower end of the actuation device from the back of the piston is provided so as to be variable. For this purpose, for example, the actuating device is held in a holder and guided. In the case of a drive using a pressurized spring, the spring acts on the actuating device so that, for example, a holder is provided with a releasable hook, in which case the hook is triggered by a trigger device. To allow the pressured spring to free, thereby accelerating the actuation device and moving the actuation device over the piston.

  Other features and details of the invention are set forth in the claims and the following description of exemplary embodiments of the invention, shown as schematics.

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

  The test device 1 according to the invention can be seen in FIG. A first holding element 3 for receiving a chamber 4 projects at right angles from the rear wall 2. The chamber 4 receives the substance 5, which can exit through a nozzle 6 at the closed end 7 of the chamber 4. The nozzle 6 is on a 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, closing 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. To this end, the actuation 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 required to do this is supplied by a 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 at a distance from the back 15 of the piston 10 It is located at.

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

  Instead of the spring 16, a pyrotechnic drive (not shown) or a gas drive (not shown) may be introduced into the drive holder 17 as the drive 12. If a pyrotechnic or gas drive is used, the entire unit of drive 12 must be replaced.

  When using the spring 16, before the triggering takes place, the spring force of the selected spring 16 is reduced by a thrust mechanism 17 in the form of a spindle or a stroke adjusting means so that the spring 16 is compressed to a defined range. 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. To this end, for example, the thrust mechanism 17 is accelerated downward in the direction of the chamber 4 by another driving device, such that the spring 16 cannot fully relax and still be subjected to force.

  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 changed. 2 shows another embodiment of the present invention. By changing the mechanism, it is possible to optimize the test device for the relevant substance 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-loaded 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 medium and the material, the time / pressure graph may change with the changeable components.

FIG.
DESCRIPTION OF SYMBOLS 1 Test device 2 Behind wall 3 First holding element 4 Chamber 5 Substance 6 Nozzle 7 Closed end of chamber 4 8 Longitudinal axis 9 Open end of chamber 4 10 Piston 11 Operating device 12 Drive 13 Operating Upper end of device 11 14 Lower end of actuation device 11 15 Back of piston 10 16 Spring 17 Thrust mechanism FIG.
DESCRIPTION OF SYMBOLS 1 Drive 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 Figure 3
1 Measuring equipment 2 Sleeve (transparent)
3 medium 4 chamber

Claims (17)

It has a first retaining element (3) for receiving the chamber (4) projecting from the wall behind (2) and comprises the following components:
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 simulating the introduction of a substance into a medium, comprising a working device (11) and a drive (12), wherein one or more components are changed. Can:
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). The distance of the piston (10) from the back (15) is provided so as to be variable; and / or c) various drives (12) are used, wherein the drives (12) are (I) selected from a spring (16) or (ii) a gas drive or (iii) a pyrotechnic drive; and / or d) the chamber (4) is made of different materials and / or different dimensions The test device, characterized in that:   Test device according to claim 1, characterized in that the chamber (4) is transparent.   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 actuation device (11) and the back surface (15) of the piston (10) is measured optically. . One or more different or identical chemical compounds, biosimilars, artificial or intact substances, inorganic or organic compounds, pure substances, natural substances, medicines, active substances, generics, solutions or solvents, additives 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 auxiliaries.   The test device according to claim 1, comprising a measurement instrument.   A kit for simulating the introduction of a substance into a medium, comprising a test device (1) according to claim 1 and a medium together with a fixture.   9. Simulating the introduction of a substance according to claim 8, characterized in that the medium is selected from the group comprising transparent, intact or artificial tissue, gel, pig skin. Kit for running.   8. The chamber of a test device according to any one of claims 1 to 7, wherein the chamber is filled with a substance and the introduction of the substance into the medium according to the modifiable components is investigated with the medium. Test method.   Claims for determining pressure / time graph and chamber pressure, piston / ram speed, heating, stability, output speed, piston deformation, chamber tightness as a function of selected substance / medium combination. 10. The test method according to 10.   The test method according to claim 10, wherein the result is read as to a result, a penetration depth of the substance into the medium, and a distribution of the substance in the medium.   The test method according to claim 10, wherein the reading is performed visually or by photograph and the data is recorded by a database.   The test method according to claim 10, which is performed repeatedly.   Use of the test device according to any one of claims 1 to 7 for screening a substance to be introduced into a medium.   Use of a test device according to any one of claims 1 to 7 for simulating the introduction of a substance into a medium. It has a first holding element (3) for receiving the chamber (4) projecting from the wall behind (2) and comprises the following components:
A chamber (4) for receiving a substance (5) having a closed end (7) and a nozzle (6) with a needle disposed therein;
A piston (10) for closing the open end (9) of the chamber (4);
A test device (1) for simulating the introduction of a substance into a medium, comprising a working device (11) and a drive (12), wherein one or more components are changed. Can:
a) the closed end (7) of the chamber (4) is provided so that it can be replaced with a nozzle (6) with various needles; and / or b) the lower end of the actuation device (11) The distance of the part (14) from the back (15) of the piston (10) is provided to be variable; and / or c) various drives (12) are used, where the drives ( 12) is selected from (i) a spring (16) or (ii) a gas drive or (iii) a pyrotechnic drive; and / or d) the chamber (4) is made of different materials and / or different dimensions The test device characterized in that it is made of:

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