CA2883034A1 - Test device for dispensing a substance into a medium - Google Patents
Test device for dispensing a substance into a medium Download PDFInfo
- Publication number
- CA2883034A1 CA2883034A1 CA2883034A CA2883034A CA2883034A1 CA 2883034 A1 CA2883034 A1 CA 2883034A1 CA 2883034 A CA2883034 A CA 2883034A CA 2883034 A CA2883034 A CA 2883034A CA 2883034 A1 CA2883034 A1 CA 2883034A1
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- CA
- Canada
- Prior art keywords
- substance
- medium
- test device
- chamber
- dispensing
- 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.)
- Abandoned
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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
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- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (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
The invention relates to a test device for dispensing a substance into a medium, comprising a chamber for receiving a substance, with a closed end and a nozzle arranged therein, a piston for closing an open end of the chamber, an actuation device and a drive, wherein one or more components can be varied: a) wherein the closed end (7) of the chamber (4) is designed to be exchangeable with different nozzles (6); b) the distance of the lower end (14) of the actuation device (11) from the rear face (15) of the piston (10) is designed to be modifiable; c) different drives (12) are used, d) the chamber (4) is made of different materials and/or different dimensions. The invention further relates to an associated test method and to the use of the test device for carrying out the test method.
Description
Test device for dispensing a substance into a medium Description The invention relates to a test device for dispensing a substance into a medium, comprising - a chamber for receiving a substance, with a closed end and a nozzle arranged therein, - a piston for closing an open end of the chamber, -"an actuation device and - a drive.
The invention further relates to an associated test method and the use of the test device for carrying out a test method.
The test devices concern devices that are described in the prior art. The applicant has described suitable devices for dispensing a substance into a medium, for example in the patent applications DE 10 2008 063 519 Al, DE 10 2007 004 211 Al, DE 10 2007 018 868 Al or DE
10 2007 032 464 Al.
There is a considerable need, e.g. in the context of a service, to test such devices in terms of the dispensing of a substance into a medium. The testing permits optimization of the dispensing of a substance into a medium. It is important that the device is variable in terms of its components, so as to permit an optimization of the dispensing of a substance into a medium.
In the prior art, the physical and chemical properties of a substance cannot be used to reach conclusions regarding the suitability of said substance for dispensing it into a medium from a device. There is therefore a need for systematic testing of a substance and variation of the components in a test device.
The invention further relates to an associated test method and the use of the test device for carrying out a test method.
The test devices concern devices that are described in the prior art. The applicant has described suitable devices for dispensing a substance into a medium, for example in the patent applications DE 10 2008 063 519 Al, DE 10 2007 004 211 Al, DE 10 2007 018 868 Al or DE
10 2007 032 464 Al.
There is a considerable need, e.g. in the context of a service, to test such devices in terms of the dispensing of a substance into a medium. The testing permits optimization of the dispensing of a substance into a medium. It is important that the device is variable in terms of its components, so as to permit an optimization of the dispensing of a substance into a medium.
In the prior art, the physical and chemical properties of a substance cannot be used to reach conclusions regarding the suitability of said substance for dispensing it into a medium from a device. There is therefore a need for systematic testing of a substance and variation of the components in a test device.
The object of the invention is therefore to make available a test device which is easy to handle and easily accessible, so that individual components can be exchanged quickly and safely.
According to the invention, this object is achieved by making available a test device as claimed in claim 1.
Embodiments of the invention are set forth in the dependent claims and are described below.
The following components can be exchanged for, and combined with, one another in a variable manner, wherein optionally at least one component can be varied:
Drive:
= Spring drive, described e.g. in patent applications DE 10 2008 063 519 Al, DE 10 2007 004 211 Al, DE 10 2007 018 868 Al or DE 10 2007 032 464 Al from the applicant.
= Gas drive, described e.g. in EP 1 125 593 El or EP
1 243 281 Bl.
= Pyrotechnic drive, described e.g. in EP 1 292 344 Bl.
Chamber:
= The front closed end of the chamber has at least one nozzle, multi-hole systems, i.e. quite a large number of nozzles are known, described e.g. in DE
20 2008 017 814 Ul, paragraph 0050. Alternatively, cannula portions can also be fitted in the nozzle bores or, instead of the nozzle bores, directly formed cannulas, mini-needles or the like can be provided.
= Instead of a flat surface, described in the applications (see above under "Spring drive"), the front closed end of the chamber can also have a curved or other three-dimentional shape, as described e.g. in WO 2009/097966 Al or DE 10 2004 007 257 Al.
= The chamber volume can be modified from 0.1 ml to ca. 2.0 ml, taking account of different internal diameters of the chamber and, consequently, the size of the support surface of the front closed end of the chamber.
= In addition, the material of the chamber can be modified. For example, the chamber can be made of plastic, glass, metal, ceramic, etc. The surface in the chamber can also be treated, in order to influence e.g. the adhesion of the substance.
Nozzle:
= The nozzle diameter varies between 0.1 and 1.5 mm, described e.g. in DE 10 2005 054 600 Al 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 can be varied in such a way that the spray is directed along the longitudinal axis and also deviating therefrom, as described e.g. in DE 20 2008 017 814 Ul (paragraph 0043 ff).
Piston:
= The piston to be received in the chamber can vary in terms of size and material. It is likewise possible to choose the distance of the piston from the ram. The piston diameter can be adapted to the chamber volume, both in shape and also in length and width. In particular, the tightness and the friction of the piston on the chamber wall can be freely chosen.
Ram or actuation device:
= The ram can be varied in length and in centering and can be adapted to the piston surface.
According to the invention, this object is achieved by making available a test device as claimed in claim 1.
Embodiments of the invention are set forth in the dependent claims and are described below.
The following components can be exchanged for, and combined with, one another in a variable manner, wherein optionally at least one component can be varied:
Drive:
= Spring drive, described e.g. in patent applications DE 10 2008 063 519 Al, DE 10 2007 004 211 Al, DE 10 2007 018 868 Al or DE 10 2007 032 464 Al from the applicant.
= Gas drive, described e.g. in EP 1 125 593 El or EP
1 243 281 Bl.
= Pyrotechnic drive, described e.g. in EP 1 292 344 Bl.
Chamber:
= The front closed end of the chamber has at least one nozzle, multi-hole systems, i.e. quite a large number of nozzles are known, described e.g. in DE
20 2008 017 814 Ul, paragraph 0050. Alternatively, cannula portions can also be fitted in the nozzle bores or, instead of the nozzle bores, directly formed cannulas, mini-needles or the like can be provided.
= Instead of a flat surface, described in the applications (see above under "Spring drive"), the front closed end of the chamber can also have a curved or other three-dimentional shape, as described e.g. in WO 2009/097966 Al or DE 10 2004 007 257 Al.
= The chamber volume can be modified from 0.1 ml to ca. 2.0 ml, taking account of different internal diameters of the chamber and, consequently, the size of the support surface of the front closed end of the chamber.
= In addition, the material of the chamber can be modified. For example, the chamber can be made of plastic, glass, metal, ceramic, etc. The surface in the chamber can also be treated, in order to influence e.g. the adhesion of the substance.
Nozzle:
= The nozzle diameter varies between 0.1 and 1.5 mm, described e.g. in DE 10 2005 054 600 Al 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 can be varied in such a way that the spray is directed along the longitudinal axis and also deviating therefrom, as described e.g. in DE 20 2008 017 814 Ul (paragraph 0043 ff).
Piston:
= The piston to be received in the chamber can vary in terms of size and material. It is likewise possible to choose the distance of the piston from the ram. The piston diameter can be adapted to the chamber volume, both in shape and also in length and width. In particular, the tightness and the friction of the piston on the chamber wall can be freely chosen.
Ram or actuation device:
= The ram can be varied in length and in centering and can be adapted to the piston surface.
(hereinbelow "variable components" or "one or more components can be varied").
The variable components can be connected to one another by means of customary fastening elements (e.g. screws, etc.). Fixed structural elements can be seen in Figure 2.
For better observation of the test processes, the materials used can be produced from a transparent material (e.g. glass, plastics). For example, the sleeve for receiving the spring drive can be made of a transparent material (see 2 in Fig. 3). Moreover, the chamber can be made transparent, such that piston processes can be observed and visually evaluated.
The test device according to the invention advantageously permits the determination of a pressure/time diagram as a function of the chosen substance/medium combination, which is shown e.g.
characteristically in Fig. 4. Further parameters of interest are chamber pressure, piston/ram speed, heating, stability, output speed, piston deformation, chamber tightness, etc., such that the qualitative suitability of a chosen test device can be decided as a function of the varied components and can be optimized.
In the context of this invention, "substance" signifies one or more different or identical chemical compounds.
The substance can likewise contain several substances.
The substance can be a functionally defined substance, such as a biosimilar, artificial or native substance, inorganic or organic compound, pure substance, natural substance, pharmaceutical, active substance, generic.
Moreover, the substance can be solid, liquid, semi-solid, semi-liquid and, if appropriate, can be present in a solution. Moreover, the substance can comprise any desired additives and auxiliaries or solvents, such as are used e.g. in galenical formulation.
To carry out a test method, provision can be made, for example, for the substance to be used in a dilution series.
Moreover, for better visualization, a color enhancer or dye can be added to the substance.
In the context of this invention, "medium" signifies an absorbable medium with any desired elasticity or mass, in particular such as native or artificial tissue, gels (ultrasonic gel, silicone gel), pig skin.
Moreover, for better visualization, a color enhancer or dye can be added to the medium. However, the "medium"
can also be, for example, a sensor, in order to determine the exit speed of the substance from the nozzle(s) and/or the exit force. Suitable measurement instruments such as pressure transducers, etc., are known to a person skilled in the art.
The medium is preferably transparent, such that the depth of penetration and distribution of a substance in the medium can be presented visually. In particular, the medium can be mechanically stabilized, e.g. by means of a container, preferably made of transparent material (plastic, glass or the like).
The medium can contain an attachment which establishes a mechanical connection to the test device, such that standardization of the test method is possible. A
person skilled in the art is able to provide suitable attachments or holders.
The variable components can be made available in a modular system or kit with or without a test device and medium and/or attachment.
The variable components can be connected to one another by means of customary fastening elements (e.g. screws, etc.). Fixed structural elements can be seen in Figure 2.
For better observation of the test processes, the materials used can be produced from a transparent material (e.g. glass, plastics). For example, the sleeve for receiving the spring drive can be made of a transparent material (see 2 in Fig. 3). Moreover, the chamber can be made transparent, such that piston processes can be observed and visually evaluated.
The test device according to the invention advantageously permits the determination of a pressure/time diagram as a function of the chosen substance/medium combination, which is shown e.g.
characteristically in Fig. 4. Further parameters of interest are chamber pressure, piston/ram speed, heating, stability, output speed, piston deformation, chamber tightness, etc., such that the qualitative suitability of a chosen test device can be decided as a function of the varied components and can be optimized.
In the context of this invention, "substance" signifies one or more different or identical chemical compounds.
The substance can likewise contain several substances.
The substance can be a functionally defined substance, such as a biosimilar, artificial or native substance, inorganic or organic compound, pure substance, natural substance, pharmaceutical, active substance, generic.
Moreover, the substance can be solid, liquid, semi-solid, semi-liquid and, if appropriate, can be present in a solution. Moreover, the substance can comprise any desired additives and auxiliaries or solvents, such as are used e.g. in galenical formulation.
To carry out a test method, provision can be made, for example, for the substance to be used in a dilution series.
Moreover, for better visualization, a color enhancer or dye can be added to the substance.
In the context of this invention, "medium" signifies an absorbable medium with any desired elasticity or mass, in particular such as native or artificial tissue, gels (ultrasonic gel, silicone gel), pig skin.
Moreover, for better visualization, a color enhancer or dye can be added to the medium. However, the "medium"
can also be, for example, a sensor, in order to determine the exit speed of the substance from the nozzle(s) and/or the exit force. Suitable measurement instruments such as pressure transducers, etc., are known to a person skilled in the art.
The medium is preferably transparent, such that the depth of penetration and distribution of a substance in the medium can be presented visually. In particular, the medium can be mechanically stabilized, e.g. by means of a container, preferably made of transparent material (plastic, glass or the like).
The medium can contain an attachment which establishes a mechanical connection to the test device, such that standardization of the test method is possible. A
person skilled in the art is able to provide suitable attachments or holders.
The variable components can be made available in a modular system or kit with or without a test device and medium and/or attachment.
The invention further relates to a test method for dispensing the substance into a medium using a test device according to the invention.
The invention thus relates to a test method in which a test device is charged with a (test) substance and, using the medium, the dispensing of the substance into the medium is examined as a function of the variable components.
The examination permits a result that allows conclusion in particular regarding the depth of penetration of the substance into a medium and also 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 charged with a substance and is dispensed into a medium and the result is read out.
In a further embodiment, the reading out can take place visually or photographically and the data can be recorded (e.g. computer, database, etc.). The setting up of a database permits comparative examinations.
Moreover, customary measurement instruments can be installed on the test device.
In particular, the invention relates to an iterative test method in which a defined result is optimized/
improved by exchange of the variable components or modification of the substance (e.g. exchange, additives), and, if appropriate, the test method is repeated.
Alternatively, the result (e.g. a defined depth of penetration in a medium) can be optimized or adapted (e.g. distribution of a substance in a medium) by means of an (electronic) calibration curve.
The invention thus relates to a test method in which a test device is charged with a (test) substance and, using the medium, the dispensing of the substance into the medium is examined as a function of the variable components.
The examination permits a result that allows conclusion in particular regarding the depth of penetration of the substance into a medium and also 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 charged with a substance and is dispensed into a medium and the result is read out.
In a further embodiment, the reading out can take place visually or photographically and the data can be recorded (e.g. computer, database, etc.). The setting up of a database permits comparative examinations.
Moreover, customary measurement instruments can be installed on the test device.
In particular, the invention relates to an iterative test method in which a defined result is optimized/
improved by exchange of the variable components or modification of the substance (e.g. exchange, additives), and, if appropriate, the test method is repeated.
Alternatively, the result (e.g. a defined depth of penetration in a medium) can be optimized or adapted (e.g. distribution of a substance in a medium) by means of an (electronic) calibration curve.
Therefore, the invention likewise relates to a test method in which the depth of penetration into the medium is examined in accordance with substance properties (e.g. the density, the viscosity, etc.) and the chamber properties (e.g. the volume, the nozzle shape or the nozzle shapes, the diameter of the nozzles, the chamber material, such as plastic, glass, metal, ceramic, and the surface).
The invention further relates to the use of a test device according to the invention for screening a substance for dispensing into a medium. In particular, the invention relates to the use of a test device according to the invention for simulating the dispensing of a substance into a medium. The screening or the simulation can be achieved preferably by carrying out the test method according to the invention.
Thus, in a preferred embodiment of the invention, provision is made for the distance of the lower end of the actuation device from the rear face of the piston to be designed to be modifiable. For this purpose provision is made, for example, for the actuation device to be both held and also guided in a holder.
Since, in the case of a drive with a stressed spring, the spring acts on the actuation device, for example releasable hooks are provided in the holder, in which case the hooks free the stressed spring in order to permit triggering by means of a trigger device, which then accelerates the actuation device and drives the latter onto the piston.
Further features and details of the invention are set forth in the claims and in the following description of an illustrative embodiment of the invention depicted in the schematic drawing, in which:
The invention further relates to the use of a test device according to the invention for screening a substance for dispensing into a medium. In particular, the invention relates to the use of a test device according to the invention for simulating the dispensing of a substance into a medium. The screening or the simulation can be achieved preferably by carrying out the test method according to the invention.
Thus, in a preferred embodiment of the invention, provision is made for the distance of the lower end of the actuation device from the rear face of the piston to be designed to be modifiable. For this purpose provision is made, for example, for the actuation device to be both held and also guided in a holder.
Since, in the case of a drive with a stressed spring, the spring acts on the actuation device, for example releasable hooks are provided in the holder, in which case the hooks free the stressed spring in order to permit triggering by means of a trigger device, which then accelerates the actuation device and drives the latter onto the piston.
Further features and details of the invention are set forth in the claims and in the following description of an illustrative embodiment of the invention depicted in the schematic drawing, in which:
Fig. 1 and Fig. 2 show a test device with the individual variable components in a front view.
The test device 1 according to the invention can be seen in Fig. 1. A first holding element 3 for receiving a chamber 4 protrudes at right angles from a rear wall 2. The chamber 4 receives a substance 5, which can emerge through a nozzle 6 at the closed end 7 of the chamber 4. The nozzle 6 lies on the longitudinal axis 8 of the chamber 4. In a continuation of the longitudinal axis 8, at the opposite, open end 9 of the chamber 4, a piston 10 is applied to the medium 5 and closes the chamber 4 with the medium located therein.
To convey the substance 5 out of the chamber 4, 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. For this purpose, the piston 10 is acted upon by an actuation device 11 and accelerated in the direction of the closed end 7 with the nozzle 6. The medium 5 located in the chamber 4 is pressed out of the chamber 4 through the nozzle 6. The force required to do this is supplied by a drive 12, which is in direct contact with the upper end 13 of the actuation device 11, while the lower end 14 of the actuation device 14 is at a distance from the rear face 15 of the piston 10.
In a first embodiment, a spring 16 is provided as drive 12. In order to prevent buckling of the spring 16, it is possible to provide either a tube surrounding the spring 16 or a guide pin arranged on the inside.
Instead of the spring 16 as drive 12, a pyrotechnic drive (not shown) or a gas drive (not shown) can also be introduced into a drive holder 17. If a pyrotechnic drive or a gas drive is used, the entire unit of the drive 12 has to be replaced.
The test device 1 according to the invention can be seen in Fig. 1. A first holding element 3 for receiving a chamber 4 protrudes at right angles from a rear wall 2. The chamber 4 receives a substance 5, which can emerge through a nozzle 6 at the closed end 7 of the chamber 4. The nozzle 6 lies on the longitudinal axis 8 of the chamber 4. In a continuation of the longitudinal axis 8, at the opposite, open end 9 of the chamber 4, a piston 10 is applied to the medium 5 and closes the chamber 4 with the medium located therein.
To convey the substance 5 out of the chamber 4, 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. For this purpose, the piston 10 is acted upon by an actuation device 11 and accelerated in the direction of the closed end 7 with the nozzle 6. The medium 5 located in the chamber 4 is pressed out of the chamber 4 through the nozzle 6. The force required to do this is supplied by a drive 12, which is in direct contact with the upper end 13 of the actuation device 11, while the lower end 14 of the actuation device 14 is at a distance from the rear face 15 of the piston 10.
In a first embodiment, a spring 16 is provided as drive 12. In order to prevent buckling of the spring 16, it is possible to provide either a tube surrounding the spring 16 or a guide pin arranged on the inside.
Instead of the spring 16 as drive 12, a pyrotechnic drive (not shown) or a gas drive (not shown) can also be introduced into a drive holder 17. If a pyrotechnic drive or a gas drive is used, the entire unit of the drive 12 has to be replaced.
When using a spring 16, it is possible for the spring force of a chosen spring 16 to be adjusted in such a way that the spring 16 is compressed to a defined extent by means of a thrust mechanism 17 in the form of a spindle or of a stroke adjustment means before triggering takes place. Therefore, the spring 16 can be used several times and the spring force adjusted in the process.
In a further embodiment, the spring rate can additionally be adjusted. This is done by means of the upper end of the spring 16 being accelerated in the direction of nozzle 6 by a further drive after the triggering has taken place. For this purpose, for example, the thrust mechansim 17 is accelerated downward in the direction of the chamber 4 by a further drive device, in such a way that the spring 16 cannot fully relax and instead is still exposed to a force.
Fig. 2 shows a further embodiment of the test device, in which the features 9, 10, 11 and 12 are structurally fixed (fixed structural elements), and the features 1, 2, 3, 4, 5 and 6 can be varied. The variation of the features permits an optimization of the test device for the relevant substance in accordance with the medium.
Fig. 3 shows an example of a fixed test device composed of at least one measurement instrument 1, a transparent sleeve 2 for receiving a spring drive, a medium 3, and a feed chamber 4 containing a nozzle.
Fig. 4 shows a characteristic time/pressure diagram for carrying out the tests using the test device. Depending on the medium and substance, the time/pressure diagram can vary using the variable components.
In a further embodiment, the spring rate can additionally be adjusted. This is done by means of the upper end of the spring 16 being accelerated in the direction of nozzle 6 by a further drive after the triggering has taken place. For this purpose, for example, the thrust mechansim 17 is accelerated downward in the direction of the chamber 4 by a further drive device, in such a way that the spring 16 cannot fully relax and instead is still exposed to a force.
Fig. 2 shows a further embodiment of the test device, in which the features 9, 10, 11 and 12 are structurally fixed (fixed structural elements), and the features 1, 2, 3, 4, 5 and 6 can be varied. The variation of the features permits an optimization of the test device for the relevant substance in accordance with the medium.
Fig. 3 shows an example of a fixed test device composed of at least one measurement instrument 1, a transparent sleeve 2 for receiving a spring drive, a medium 3, and a feed chamber 4 containing a nozzle.
Fig. 4 shows a characteristic time/pressure diagram for carrying out the tests using the test device. Depending on the medium and substance, the time/pressure diagram can vary using the variable components.
List of reference signs:
Fig. 1 1 test device 2 rear wall 3 first holding element 4 chamber substance 6 nozzle 7 closed end of the chamber 4 8 longitudinal axis 9 open end of the chamber 4 piston 11 actuation device 12 drive 13 upper end of the actuation device 11 14 lower end of the actuation device 11 rear face of the piston 10 16 spring 17 thrust mechanism Fig. 2 1 drive 2 securing means/trigger 3 piston distance 4 piston 5 chamber 6 nozzle (geometry) 7 chamber diameter 8 chamber volume 9 chamber fastening 10 holder/connection/drive chamber 11 ram 12 sleeve Fig. 3 1 measurement instrument 2 sleeve (transparent) 3 medium 4 chamber
Fig. 1 1 test device 2 rear wall 3 first holding element 4 chamber substance 6 nozzle 7 closed end of the chamber 4 8 longitudinal axis 9 open end of the chamber 4 piston 11 actuation device 12 drive 13 upper end of the actuation device 11 14 lower end of the actuation device 11 rear face of the piston 10 16 spring 17 thrust mechanism Fig. 2 1 drive 2 securing means/trigger 3 piston distance 4 piston 5 chamber 6 nozzle (geometry) 7 chamber diameter 8 chamber volume 9 chamber fastening 10 holder/connection/drive chamber 11 ram 12 sleeve Fig. 3 1 measurement instrument 2 sleeve (transparent) 3 medium 4 chamber
Claims (14)
1. A test device (1) for dispensing a substance into a medium, comprising - a chamber (4) for receiving a substance (5), with a closed end (7) and a nozzle (6) arranged therein, - a piston (10) for closing an open end (9) of the chamber (4), - an actuation device (11) and - a drive (12), characterized in that one or more components can be varied:
a) wherein the closed end (7) of the chamber (4) is designed to be exchangeable with different nozzles (6); and/or b) the distance of the lower end (14) of the actuation device (11) from the rear face (15) of the piston (10) is designed to be modifiable;
and/or c) different drives (12) are used, and/or d) the chamber (4) is made of different materials and/or with different dimensions.
a) wherein the closed end (7) of the chamber (4) is designed to be exchangeable with different nozzles (6); and/or b) the distance of the lower end (14) of the actuation device (11) from the rear face (15) of the piston (10) is designed to be modifiable;
and/or c) different drives (12) are used, and/or d) the chamber (4) is made of different materials and/or with different dimensions.
2. The test device as claimed in claim 1, characterized in that the drive (12) is composed of a) a spring (16) or b) a gas cartridge or c) a pyrotechnic drive.
3. The test device as claimed in claim 2 a), characterized in that the spring force is adjustable.
4. The test device as claimed in claim 2 a), characterized in that the spring rate is adjustable.
5. The test device as claimed in claim 1, characterized in that the distance between the lower end (14) of the actuation device (11) and the rear face (15) of the piston (10) is measured optically.
6. The test device as claimed in claim 1, containing a substance chosen from the group comprising one or more different or identical chemical compounds, in particular biosimilar, artificial or native substance, inorganic or organic compound, pure substance, natural substance, pharmaceutical, active substance, generic, in particular a solid, liquid, semi-solid, semi-liquid substance, if appropriate in a solution or solvent, additives and auxiliaries.
7. A kit or modular system containing a test device as claimed in claim 1 and a medium, if appropriate together with attachment.
8. A kit or modular system, characterized in that the medium is chosen from the group comprising native or synthetic tissue, gels (ultrasonic gel, silicone gel), pig skin, preferably transparent.
9. A test method, characterized in that a test device as claimed in one of the preceding claims is charged with a substance and, using the medium, the dispensing of the substance into the medium is examined as a function of the variable components.
10. The test method as claimed in claim 9, in which the results are read out, in particular results concerning the depth of penetration of the substance into a medium and also the distribution of the substance in the medium.
11. The test method as claimed in claim 9, in which the reading out takes place visually or photographically and, if appropriate, the data are recorded, in particular by means of a database.
12. The test method as claimed in claim 9, in which the test method is carried out iteratively.
13. Use of the test device as claimed in one of the preceding claims for screening a substance for dispensing into a medium.
14. Use of the test device as claimed in one of the preceding claims for simulating the dispensing of a substance into a medium.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12182358.7 | 2012-08-30 | ||
| EP12182358 | 2012-08-30 | ||
| PCT/EP2013/068040 WO2014033287A1 (en) | 2012-08-30 | 2013-08-30 | Test device for dispensing a substance into a medium |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2883034A1 true CA2883034A1 (en) | 2014-03-06 |
Family
ID=46801334
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2883034A Abandoned CA2883034A1 (en) | 2012-08-30 | 2013-08-30 | Test device for dispensing a substance into a medium |
Country Status (7)
| Country | Link |
|---|---|
| EP (1) | EP2890967A1 (en) |
| JP (2) | JP6437436B2 (en) |
| CN (1) | CN104736992A (en) |
| BR (1) | BR112015004078B1 (en) |
| CA (1) | CA2883034A1 (en) |
| HK (1) | HK1207153A1 (en) |
| WO (1) | WO2014033287A1 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014033287A1 (en) * | 2012-08-30 | 2014-03-06 | Lts Lohmann Therapie-Systeme Ag | Test device for dispensing a substance into a medium |
Family Cites Families (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS4910152Y1 (en) * | 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 (en) * | 1994-11-19 | 1997-11-05 | 韦斯顿医疗有限公司 | Medical glass container suitable for use in needleless injectors |
| GB9425642D0 (en) * | 1994-12-20 | 1995-02-22 | Weston Medical Ltd | Filling device |
| US5697917A (en) * | 1996-02-29 | 1997-12-16 | Medi-Ject Corporation | Nozzle assembly with adjustable plunger travel gap |
| 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 (en) * | 2000-12-08 | 2002-06-25 | Eisuke Fujimoto | Needle-less syringe |
| JP5180195B2 (en) * | 2006-06-07 | 2013-04-10 | アキュショット インク | Filling mechanism for needleless syringes |
| CN200998469Y (en) * | 2007-02-02 | 2008-01-02 | 曾沂水 | Calling device-accessory for transfusion |
| DE102007031630B3 (en) * | 2007-07-06 | 2008-12-24 | Lts Lohmann Therapie-Systeme Ag | Disposable injector with at least one support rod |
| DE102007032463A1 (en) * | 2007-07-10 | 2009-01-15 | Lts Lohmann Therapie-Systeme Ag | Disposable injector with at least one positively decoupling towing hook |
| US8021323B2 (en) * | 2007-07-27 | 2011-09-20 | Allergan, Inc. | Soft tissue augmentation by needle-free injection |
| CN201131986Y (en) * | 2007-10-29 | 2008-10-15 | 冯少为 | Electric needleless injectors |
| US8992485B2 (en) * | 2009-10-30 | 2015-03-31 | Sanofi-Aventis Deutschland Gmbh | Drug delivery devices and method of assembly |
| CN102125712B (en) * | 2010-01-14 | 2013-09-18 | 北京快舒尔医疗技术有限公司 | Needleless syringe preloaded with medicament |
| US20130304017A1 (en) * | 2012-05-09 | 2013-11-14 | Bioject, Inc. | Peformance of needle-free injection according to known relationships |
| WO2014033287A1 (en) * | 2012-08-30 | 2014-03-06 | Lts Lohmann Therapie-Systeme Ag | Test device for dispensing a substance into a medium |
-
2013
- 2013-08-30 WO PCT/EP2013/068040 patent/WO2014033287A1/en active Search and Examination
- 2013-08-30 JP JP2015529036A patent/JP6437436B2/en not_active Expired - Fee Related
- 2013-08-30 CN CN201380054269.1A patent/CN104736992A/en active Pending
- 2013-08-30 BR BR112015004078A patent/BR112015004078B1/en not_active IP Right Cessation
- 2013-08-30 EP EP13771402.8A patent/EP2890967A1/en not_active Ceased
- 2013-08-30 CA CA2883034A patent/CA2883034A1/en not_active Abandoned
-
2015
- 2015-08-07 HK HK15107638.6A patent/HK1207153A1/en unknown
-
2018
- 2018-06-27 JP JP2018121443A patent/JP6633141B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| HK1207153A1 (en) | 2016-01-22 |
| WO2014033287A1 (en) | 2014-03-06 |
| JP6633141B2 (en) | 2020-01-22 |
| JP2018185318A (en) | 2018-11-22 |
| BR112015004078A2 (en) | 2017-07-04 |
| EP2890967A1 (en) | 2015-07-08 |
| JP6437436B2 (en) | 2018-12-12 |
| JP2015528570A (en) | 2015-09-28 |
| CN104736992A (en) | 2015-06-24 |
| BR112015004078B1 (en) | 2020-05-05 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20180228 |
|
| FZDE | Discontinued |
Effective date: 20220511 |
|
| FZDE | Discontinued |
Effective date: 20220511 |