DE4432993C1 - Mixing device for agents to be administered by means of a syringe - Google Patents

Description

The invention relates to a mixing device for the Preparation of syringes to be administered Agents such as diagnostics, therapeutics, or homeopathics the autologous blood treatment, containing a first injection Connection supports and a second syringe with connection piece and one the two syringes over the connecting piece interconnectable adapter with a continuous over its length having different sized cross sections Flow channel, so that the inside of the first and second syringe communicate with each other via the adapter.

In the medical field, it is often necessary for Administration of diagnostics, such as X-ray contrast media, MR Contrast agents, echo contrast agents, therapeutics, in the Autologous blood treatment or when administering Homeopathic drugs to achieve a homogenization of the remedies to produce homogeneous suspensions or emulsions or at Agents, such as echo contrast agents, the surfactants contain to promote the formation of microbubbles.  

A mixing device for is already known from EP 0148 116 A1 Syringes known in which an adapter for connecting the two Syringes is used, which is constructed symmetrically, and its flow channel in the middle of the transition from one Syringe end to the other syringe connection a constriction has to, when pumping back and forth to be homogenized From one syringe over the adapter into the other Syringe and back to achieve a good mix.

EP 0266 058 A2 also shows a mixing device with two Syringes and one the two syringes together connecting adapter, the flow channel of the adapter a has a constant cross-section. This arrangement is used for uniform mixing of a powdery material with a liquid material for making a collagen mineral Bone repair compound.

DE 38 38 530 A1 describes a packaging and mixing device described for a two-component mass (adhesive) that consists of there are two flexible containers for the two components, the two containers using a tubular adapter be connected to each other, the flow channel through to the Deflection walls arranged offset for better Mixing the components as they are pressed through from one to the other another container there and back.

WO 92/11928 A1 describes a mixing device for Microbubble echo contrast media known to use a syringe is inextricably linked to a mixing chamber attached to their Inside walls also mixing elements to redirect the medium flowing through and with a syringe, containing the medium in which the microbubbles are generated are supposed to be connected by pumping the back and forth Medium through the mixing chamber, the microbubbles produce. The defined volume of the mixing chamber enables to generate a defined number of microbubbles,  if an equal agitation performance, d. H. pumping back and forth, is present.

In the known mixing devices according to EP 0148 116 A1 and EP 0266 058 A2 are uniform mixtures, Homogenizations or homogeneous suspensions or emulsions either only after prolonged agitation, i.e. H. multiple back and forth Pump it up or use suitable media, for example two liquid media or a liquid and a solid Medium to reach. The above Mixing devices with two syringes and an adapter for two media to be mixed are only for designed a single use case. The above Mixing devices are not for different Applications, for example mixing two components or Generation of microbubbles in a component or Shake homeopathic, suitable.

The mixing device known from WO 92/11928 A1 is for the use of an agent suitable with microbubbles to be provided, filling the second syringe is not practical with another component.

The invention has for its object a Mixing device using two syringes and one Adapters for the homogeneous mixing and introduction of To create energy in different media. The Mixing device is intended for use in the medical field as Ballast for the administration of diagnostics, Therapeutics and in autologous blood treatment as well as in the administration of homeopathic drugs can be used.

The activation of the media (substances) takes place in the Mixing device by vigorous pumping back and forth Substance (s) between the syringes through which this connecting flow channel of the adapter. The Cross-sectional changes in the flow channel cause one  Turbulence and thus the activation or mixing and Homogenization.

According to the invention, an embodiment of a mixing device according to claim 1 to solve the problem proposed in which the flow channel of the adapter a central with the two lateral connection areas of the Flow channel connected via narrowing of the flow channel Has mixing chamber and in the mixing chamber at least one Carrier element is arranged secured in position. Here is that Ratio of the diameter of the flow channel in the range of Mixing chamber and the two-sided adjoining Constrictions preferably according to the characterizing part of claim 25 to train. The cross section of the narrowing should not be too become small so that the flow resistance does not become too high. The constrictions are preferably on the inlet side of the mixing chamber and the same size on the output side.

The mixing device according to the invention is based on a Mixing chamber of defined volume with defined bilateral Entrances and exits each in the form of a constriction that when using two syringes for multiple pumping back and forth from media in both pump directions to an effective one Leads to turbulence. Furthermore, the flow path in the Mixing chamber changed by the use of a carrier element, d. H. deflected from the axial flow direction, whereby a further activation or mixing of the media flowing through it. That in the mixing chamber Carrier element used according to the invention is in the Mixing chamber arranged securely, it both statically arranged and rotatable, d. H. as Rotor can be arranged.

The adapter proposed according to the invention for the Mixing device enables homogeneous mixing and that Introducing energy into different media Use of two syringes connected by means of the adapter. To The mixing can take place from the syringe in which  the mixed agent is ready, the other syringe or the other syringe and adapter are removed and one Patient cannula to be drawn onto the filled syringe then inject the agent so prepared.

Advantageous developments of the invention are the characteristic features of the subclaims.

The arrangement of the carrier element according to the invention, optionally two or more support elements and their possible equipment with substances containing active ingredients or a suitable selection of materials from which the carrier elements are made, such as gold, silver, Copper or suitable plastics can have side effects can be achieved, the range of use of the Mixing device according to the invention for various significantly increase medical treatments. So it will possible to use the mixing device according to the invention with adapter Carrier element for both the administration of diagnostics, such as for example echo contrast agents to form Microbubbles, therapeutics, homeopathics and also for Improvement of different methods of autologous Use treatment.

To the universal applicability of the invention To enable adapters and thus the mixing device proposed to design the adapter so that the respective Interfaces as Luer-Lock female-female or Luer-Lock are male-female trained. Furthermore is preferred to design the adapter in the connection area so that he on standard syringes with a Luer-Lock cone according to DIN 13090, parts 1 to 3 of sizes 5 to 50 ml can. It is also possible to attach the adapter to a syringe to be permanently attached.

With the same design of an adapter, it is also possible differently trained for different applications Insert carrier elements into the mixing chamber of the adapter, see above  that an optimization to the respective tasks or means to be mixed is possible.

An advantage of the invention that cannot be overlooked is therein see that with the carrier element an active ingredient in the mixing agents can be introduced subsequently.

Depending on the indication area, the carrier element can consist of one suitable material. In the carrier material an active ingredient can be incorporated, for example antithrombic properties for autologous blood treatment with Ozone. It is also possible to use this active ingredient only in a coating applied to the carrier element to incorporate. It is also possible to manufacture or Coating the carrier element from or with biocides equipped materials. The range of applications of the adapter according to the invention can be increased significantly if the carrier element is made of silver, gold or Copper is made or at least coated with it. Here, a can be used as the base material for the carrier element medically suitable plastic, for example one for the processing in echo contrast media is used more appropriately will.

The adapter or the mixing chamber of the adapter and that The dimensions of the support element must be coordinated so that the Carrier element can be used either as a stator or rotor can. The position of the support element is secured in each case via a defined bearing on the respective end faces the mixing chamber, in particular the pinhole, which the Effectiveness of the adapter is supported. This is preferred Carrier element used as a rotor in therapeutics and as Stator for diagnostics with the invention Mixing device should be mixed and homogenized.

The invention enables an adapter for mixing devices of the generic type which allows the Mixing devices regardless of the to be mixed or with  Use energy to be charged medium. The quality which is due to mixing or energizing easy to reproduce and display. This helps the defined mixing chamber with narrowed, especially as Pinhole trained entrance and exit, which Ratio of the narrowing preferably between 1: 3 to 1: 5 is.

The carrier element is preferably designed so that it both in the axial direction of the flow channel in which it is used can be flowed through in the mixing chamber as well as transversely to it is, at least in some areas. For this purpose, the carrier element be open-pore or porous or perforated.

To secure the position of the support element in the Mixing chamber to allow in a simple way, at the same time use as a stator or rotor, it is suggested Carrier element, viewed in the axial direction, at one end with possibly rounded tip (bow) and on the other Form the end with a blunt straight end face (rear).

According to a preferred embodiment, the carrier element has the Shape of a twisted leaflet. This leaflet is rigid and self-supporting and, for example, from one Plastic for medical purposes or from a metal such as Silver, gold, copper or chrome-nickel, manufactured and optionally provided with a coating. This twisted leaflets also points transverse to the axial Towards holes in the leaflet that are defined in a Arrangement and size are designed for additional To generate turbulence in the medium flowing through.

Another embodiment of the Carrier element sees the use of a braid, in particular a braid made of chrome-nickel wire or a braid made of plastic coated wire, optionally also a braid, for example made of copper  or silver wire in front. This braid can also be used be coated.

For example, the carrier element can be rolled Braid with a defined mesh size and diameter of Be made wire, which also bow and tail-shaped to the End faces is formed and preferably still in the middle has an additional constriction. Others depending on suitable media to flow through Carrier element designs are possible.

Is an open-pore carrier material for the carrier element provided, an active ingredient can be incorporated into this or be superficially applied.

For easy manufacture and handling and assembly of the Adapters with inserted carrier element are proposed to form the adapter in several parts, for example in two parts, such that before assembling the adapter from the Individual parts can be used in the mixing chamber, the carrier element is. The parts of the adapter can then, for example cannot be removed by welding or gluing or mechanically with each other by locking, jamming or the like get connected. The adapter is also preferably made of one suitable plastic approved in medical technology manufactured.

Depending on whether the mixing device according to the invention only for the treatment and activation of one medium or two Media are made to a desired medical product is only one of the two syringes or both syringes to fill a medium.

The invention is illustrated in the drawing Exemplary embodiments explained. Show it

FIG. 1 schematically the interconnection of two syringes via an adapter,

Fig. 2 is a longitudinal section through an adapter in an exploded view, in enlargement,

Fig. 3 shows a longitudinal section through the adapter of FIG. 2 with introduced carrier element,

Fig. 4, the carrier element according to FIG. 3 in two views,

Fig. 5 shows a further adapter in longitudinal section with supporting member in magnification,

Fig. 6, 7, two support elements in the form of flakes in the untwisted state,

Fig. 8 shows the syringe of FIG. 1 with a medium,

Fig. 9, the second syringe of FIG. 1 without medium,

Fig. 10, 11, the syringes with medium after mixing with patient cannula for injection.

In Fig. 1, the mixing device with syringe 1 , syringe 2 and the two syringes connecting adapter 3 for a 5 ml syringe can be seen in an enlarged view and partial section. The syringe 1 contains the agent 6 to be treated, for example an echo contrast agent, in which microbubbles are to be generated by activation, by this agent 6 in the direction of the arrows P1 and P2 in each case from the syringe 1 through the flow channel of the adapter 3 into the syringe 2 and back again is pumped several times (agitation). The invention is concerned with the design of the adapter 3 , which has a special mixing chamber 30 with a carrier element 4 inserted therein. Each syringe 1 , 2 has the piston rod 12 or 22 with piston 11 or 21 . The syringes 1 , 2 and the adapter 3 are detachably connected axially one behind the other on the longitudinal axis X by plugging them together. The syringes 1 , 2 have connection pieces 13 , 23 with which they engage in corresponding connection areas of the adapter 3 .

In FIG. 2, the formation of the adapter 3 in an enlarged view is shown in principle. For manufacturing reasons and in order to be able to insert a carrier element into the central mixing chamber 30 of the adapter 3 , the adapter 3 is preferably of multiple parts, at least two parts, in the example according to FIG. 2 the dividing line at an end face of the mixing chamber into the parts 3 a and 3 b is made with the angled end faces 301 and 302 . The flow channel passing through the adapter 3 in the longitudinal axis X is formed by the configuration with the central mixing chamber 30 , the insert cones 36 , 37 provided on the two connection areas 38 and 39 for the connecting pieces of the syringes, and those in the end faces 32 , 31 of the mixing chamber 30 Pinholes 35 and 33 , 34 designed with narrower and wider cross sections. In particular, it is essential that the central mixing chamber 30 with a relatively large cross section has a substantial narrowing of the flow channel at both outlets or entrances due to the formation of perforated shutters. The lateral connection areas 38 , 39 of the adapter 3 for the syringes are designed as Luer lock connections, ie either the free ends are both female connections, as in the example shown with the inner cone 36 or 37, or one end as a male connection with a corresponding outer cone and the other end designed as a female connection. In order to use adapter 3 as a universal adapter, the connections are designed for standard syringes with a Luer-Lock cone in accordance with DIN 13090, in particular for syringes of sizes 5 to 50 ml.

Before the adapter parts 3 a, 3 b are joined together to form the uniform adapter 3, a carrier element 4 , for example the carrier element shown in FIG. 4 in two views, made of a tubular mesh is inserted into the mixing chamber 30 , see FIG. 3 Pipe weave, for example a chrome-nickel steel, which is then covered with a layer of precious metal, has a cone-shaped shape with a tip 41 - bow area and a blunt end 43 - rear area - and a constriction 42 in the middle area. As can be seen from FIG. 4, in particular the top view A, the carrier element 4 is created from a wire mesh 40 rolled around the longitudinal axis X and the shape of the tip and the constriction is carried out by pressing together. This support member may be incorporated into the also a drug which has, for example, anti-thrombic properties, the adapter 3 is inserted into the mixing chamber 30 is still divided state and then the two adapter parts 3 are a, 3 b at their interface 8 glued together or welded, see Fig. 3. the adapter shown in FIG. 3, 3 with support member 4 in the mixing chamber is now ready to each syringe 1, 2, see Fig. 1, which are inserted into the terminal regions 37, 38, to form a mixing device. The adapter with mixing chamber 30 and carrier element 4 is designed so that the medium to be acted upon can flow through in both directions, with thorough mixing and swirling being made possible in a very short time.

In FIG. 5, a further possibility of designing an adapter 3 having a central mixing chamber 30 and inserted herein carrier element 4 is shown. Here, too, the adapter 3 is composed of two parts 3 a, 3 b in such a way that the mixing chamber 30 is formed in a part 3 a and the part 3 b serves, as it were, as an end cover for the mixing chamber with passage in the form of the perforated diaphragm 32 . At the other end of the mixing chamber, a web 31 is again provided on the end face as a delimitation to the connection area and connection cone 36 , which has a passage in the form of an aperture 33 a as on the opposite side. The two adapter parts 3 a, 3 b can either be firmly connected by welding or gluing or, as in the example shown, by means of an external clamping slide 9 , so that the adapter can be used as a rotor or stator, or also by means of a clamping ring 9 , which can optionally also be glued on. The subdivision of the adapter 3 into two parts 3 a, 3 b for the assembly, in particular for the insertion of the carrier element 4 into the mixing chamber 3 can also be carried out at another point in the chamber area.

The connections of the adapter 3 according to FIG. 5 are in turn also designed as Luer lock connections in the example shown as female connections. As the support element 4 also the carrier element according to FIG. 4 are inserted from a rolled mesh in pin shape. However, other shapes of the carrier element 4 are also possible, for example a twisted leaflet as the carrier element 4 , as shown in FIG. 5. Such a twisted leaflet 4 is produced, for example, from an as yet untwisted sheet as shown in FIG. 6, which has a tip 41 at the front in the axial direction and a blunt side - rear side - 43 at the other end. The leaflet is perforated transversely to the longitudinal axis X, specifically with a plurality of holes 48 of different sizes, which are provided in a predetermined arrangement, in order then to bring about additional cross flows in the mixing chamber. The leaflet shown in FIG. 6 is then twisted, for example as can be seen in the arrangement according to FIG. 5. The tip of the leaflet 4 , which is then twisted, can also be rounded, as shown in FIG. 7. The tip 41 of the support element 4, both according to the embodiments according to FIGS. 6 and 7 or Fig. 4, the guide and securing the position used of the support element 4 within the mixing chamber by this tip 4 at the pinhole 35 at the one end-side outlet of the mixing chamber 30 is guided, while the carrier element 43 is guided with its rear side 43 in the region of the other end output on the web 31 of the mixing chamber. If the carrier element 4 is clamped between the two end faces of the mixing chamber, it can be used as a stator, but if it is not clamped, it can also act as a rotor.

In FIGS. 8 and 9 are once again the two syringes 1 and 2, which together with the adapter 3 with inserted support element 4, the mixing device shown in detail. Two identical syringes 1 , 2 , as are commercially available, are preferred with a desired size, for example 5 ml holding volume here. The syringes are equipped here with a standardized connection piece 13 , 23 , to which the respective connection areas 36 , 39 and 37 , 38 of the adapter are assigned. Depending on whether only one component 6 is subjected to agitation, mixing and the application of energy or two media, only one of the two syringes, in the example shown syringe 1 , is filled with the agent 6 or else both syringes. The syringes 1 , 2 , adapter 3 with carrier element 4 and at least one means 6, which are joined to form the mixing device according to FIG. 1, are pumped back and forth by means of the pistons 11 , 21 , as shown in FIG. 1 and explained above of the piston rods 22 , 12 in the direction of the arrows P1 or P2 is moved back and forth through the mixing chamber 30 with the carrier element 4 until there is sufficient mixing. At the end of this agitation process, the desired finished prepared agent 6 a is obtained in one of the syringes, for example syringe 1 , see FIG. 10, which is now to be injected. Here, the mixing device of the prepared means 6 a filled syringe 1, both the syringe 2 may be withdrawn and the adapter 3 after separation, so that then directly carried out by placing a patient cannula 5 to the connecting piece 13 of the syringe 1, the injection to the patient can be. However, it is possible, as shown in FIG. 11, to leave the adapter 3 on the syringe 1 filled with the prepared agent 6 a and only withdraw the syringe 2 . Then a patient cannula 5 is inserted into the adapter 3 in place of the syringe 2 , so that when the prepared mixture 6 a is injected, it again flows through the mixing chamber 30 with the carrier element 4 of the adapter 3 and is mixed immediately before the injection. The connections must be adapted to suit female / male or vice versa.

The mixing device according to the invention enables one reproducible and therefore necessarily correct feasible mixing of appropriate diagnostics and Therapeutics, so that a higher security in the Application takes place. By using a mixing chamber with a predetermined volume, d. H. also predetermined air volume it is also possible to in accordance with defined amounts of air to incorporate appropriate means as needed and desired. The Mixing device according to the invention is not only one special therapeutic or diagnostic agent or Filler suitable for processing, but in a universal Assign for the most diverse by means of an injection administering agents suitable, consisting of liquid, pasty or liquid and powdery or liquid, pasty and gaseous media are assembled and homogenized have to.

Claims (25)

1. Mixing device for the preparation of agents to be administered by means of a syringe, such as diagnostics, therapeutic agents, homeopathics or in the case of autologous blood treatment, comprising a first syringe with connecting piece and a second syringe with connecting piece and one connecting the two syringes to one another via the connecting piece Adapter with a continuous flow channel having cross sections of different sizes over its length, so that the interior of the first and second syringes communicate with one another via the adapter, characterized in that the flow channel of the adapter ( 3 ) has a central connection area with the two lateral connection areas ( 37 , 36 ) of the flow channel via constrictions ( 33 , 34 , 35 ) of the flow channel connected mixing chamber ( 30 ), and arranged in the mixing chamber ( 30 ) at least one support element ( 4 ) secured. 2. Mixing device according to claim 1, characterized in that the carrier element as a stator or rotor is formed. 3. Mixing device according to claim 1 or 2, characterized in that the carrier element both in axial direction (X) of the flow channel as well as transverse to it is flowable. 4. Mixing device according to one of claims 1 to 3, characterized in that the carrier element from a inert plastic permitted for medical use is made.   5. Mixing device according to one of claims 1 to 3, characterized in that the carrier element from a Metal, such as copper, silver, gold, chrome-nickel alloy, is made. 6. Mixing device according to one of claims 1 to 5, characterized in that the carrier element with gold, Silver or copper is coated. 7. Mixing device according to one of claims 1 to 6, characterized in that the carrier element from a a material containing or containing a biocide a coating containing a biocide is provided. 8. Mixing device according to one of claims 1 to 6, characterized in that the carrier element from a Active substance with antithrombic properties containing material or with an antithrombic Containing properties containing active ingredient Coating is provided. 9. Mixing device according to one of claims 1 to 8, characterized in that the carrier element is open-pore or is porous or perforated. 10. Mixing device according to one of claims 1 to 9, characterized in that the carrier element in axial Considered longitudinal extension at one end optionally rounded tip-like shape and on other end with a blunt (straight) face is trained. 11. Mixing device according to one of claims 1 to 10, characterized in that the constrictions that limit the mixing chamber ( 30 ) on the end face are designed as perforated shutters ( 33 , 34 , 35 ). 12. Mixing device according to one of claims 1 to 11, characterized in that the positional securing of the carrier element within the mixing chamber ( 30 ) takes place at the narrowings delimiting the end of the mixing chambers ( 30 ). 13. Mixing device according to one of claims 1 to 12, characterized in that the support member has the shape of a twisted leaflet. 14. Mixing device according to claim 13, characterized in that the leaflet in a defined Way is perforated. 15. Mixing device according to one of claims 1 to 12, characterized in that the carrier element from a Braid is made. 16. Mixing device according to claim 15, characterized in that the braid around the longitudinal axis is rolled up. 17. Mixing device according to one of claims 15 or 16, characterized in that the carrier element made of braid is compressed on one end face ( 41 ) and is additionally provided with a constriction ( 42 ) in the central region. 18. Mixing device according to one of claims 1 to 17, characterized in that one of the two syringes contains fluid. 19. Mixing device according to one of claims 1 to 17, characterized in that both syringes ( 1 , 2 ) contain a medium for the preparation of an agent. 20. Mixing device according to one of claims 1 to 19, characterized in that the connection areas of the Adapters as female Luer lock connections or male and female Luer lock connection are. 21. Mixing device according to claim 20, characterized in that the connection areas of the Adapters on syringes with Luer-Lock cone according to DIN 13090, Parts 1 to 3 of sizes 5 to 50 ml can be attached. 22. Mixing device according to one of claims 1 to 21, characterized in that the adapter ( 3 ) is constructed in several parts, the carrier element ( 4 ) being insertable into the mixing chamber ( 30 ) before the adapter is assembled. 23. Mixing device according to claim 22, characterized in that the parts forming the adapter ( 3 a, 3 b) are inextricably linked, for example by welding or gluing. 24. Mixing device according to one of claims 1 to 23, characterized in that the adapter consists of an inert Plastic is made. 25. Mixing device according to one of claims 1 to 24, characterized in that the ratio of the diameter (D) of the mixing chamber ( 30 ) to the diameters (d1) of the subsequent constrictions ( 33 , 34 , 35 ) of the flow channel on each side 3 : 1 to 5: 1, whereby the smallest diameter of the flow channel in the area of a constriction should be at least 1 mm.