Improvement of injection cartridges

 

(57) Abstract:

The invention is intended for use in injection. Injection cartridge (1) single-chamber or dual-chamber type, in which the front piston (3) is used for draining injectable drug (2) through the outlet (4) for treatment. Secondary camera is located behind the front piston (3) and sealed at its rear end by the rear piston (10). Additional Luggage contains leaching fluid (9), and through the bypass connection (11) located on the front end of the cartridge (1), rinsing liquid (9) can flow around the front of the piston (3) and pushed through the exhaust pipe (4). The discharge port in the result, washed and remains injectable drug (2) in the above-mentioned exhaust pipe will be pushed for the introduction of the patient. The technical result - the opportunity to use the injectable drug. 4 C. and 24 C.p. f-crystals, 15 ill.

The invention relates to improvements in injection cartridges for the purpose of parenteral injection or infusion. In particular, the invention relates to the improvement of such injection cartridges, which enables better ispolzovaniem injection cartridge of the invention. In addition, the invention also relates to the use of injectable cartridge for intravenous injection.

It is established that the injection cartridge has wide application in the treatment of injectable pharmaceutical drugs by parenteral injection or infusion. These cartridges have many significant advantages, such as ease of manipulation, and a reduced risk of microbial contamination. Injection cartridge typically includes a tubular cylinder containing liquid injectable drug. At its front end the cylinder is sealed with a stopper or septum, through which can pass the output tube, as, for example, injection needle or cannula, or tube for infusion. At its rear end of the cartridge is closed by a piston which can move forward to displace injectable drug from the cartridge via the outlet tube. This type of injection cartridges is known as a single-chamber injection cartridge.

A well-known two-chamber injection cartridges. These cartridges are designed for use injectable drugs, which are unstable in their ready-to-use condition, and the space between the front shutter and rear nacirema drug and the rear chamber contains a liquid component of this medication. In a predetermined position in the cartridge has a liquid bypass connection, located in the inner wall of the cartridge so that the liquid component could bypass the movable separation wall and to flow into the front chamber for mixing with the solid component. When the rear piston is applied directed forward pressure, this pressure is transmitted through the liquid and causes the movable wall to move forward, and when this wall is the position of the bypass connection, the fluid begins to flow over the wall to blend in with the component in the anterior chamber. Thus, both components can be mixed with each other just before the injections, and for the degradation of already mixed drug no time. When all the liquid is transferred to the front camera, the rear piston abuts against the movable wall, and upon further forward movement they will act as a single piston to displace the drug from the cartridge.

In U.S. patent N 4.439.184 described dvuhzonovy syringe with dual camera, designed for sequential introduction of two different liquids. In the preferred embodiment for the preparation of the urethra to the Catete the anesthetic allow the catheter easier to slip into the urethra.

Design and principle of operation of single-chamber and dual-chamber cartridges for injection are well-known to experts, and there is no need to describe them here in more detail.

When the introduction of liquid drug from the injection cartridge is finished and the rear piston is in its most forward position ahead of the piston in the front end part of the output of the cartridge is still some dead space. This dead space can be significant, especially when between the output and the needle or cannula is a tube of some length. This is a disadvantage, because it means that a number of pharmaceutical drug is not used by the patient. This disadvantage is exacerbated by the use of very expensive pharmaceutical drugs, such as growth hormones and some peptides.

To eliminate this drawback was tried many ways. One of these ways was the absorption of a certain amount of blood in the cartridge after the injection, and injecting it back to the patient so that the output tube was filtered in this way. This practice, however, is not recommended, as there is a risk that the components of the century. Another way is to remove syringe containing a pharmaceutical product, and its replacement by a syringe containing wash liquid, such as physiological salt solution, in order to complete the injection. It is difficult and time consuming, but also increases the risk of leakage and contamination.

The above-mentioned disadvantages are eliminated by the improvements of the present invention. According to the invention the improvement lies in the fact that the liquid drug is expelled from the cartridge through the outlet tube located at the front end of the said cartridge, by displacement of the piston located in said cartridge. The difference of the present invention is that behind the front piston to eject the drug cartridge is an additional chamber containing wash liquid, said additional or auxiliary chamber sealed at its rear end by rolling the rear of the piston, while the liquid bypass connection is located in the front end of the cartridge, so that when the front piston is in the forward position, the wash liquid can be forced to flow said front piston and then on the nom embodiment of the invention, the injection cartridge is a two-chamber cartridge, in which the front chamber contains a solid component of the drug, the rear chamber contains a liquid component of the drug, and the said chamber is divided superseded by a dividing wall or partition, the rear liquid bypass connection is located in the inner wall of the cartridge, so that the liquid component can be forced to work around mentioned the separation wall and to flow into the front chamber for mixing with the solid component, referred back camera is closed at its rear end through the front of the piston, and the secondary or auxiliary chamber for washing liquid is located behind the said front piston in said cartridge and closed at its rear end by the rear of the rolling piston.

In another preferred embodiment, the volume of wash liquid is equal to at least twice the combined amount of any space in the cartridge ahead of the front piston is in its most forward position and space in the exhaust pipe.

Hereinafter the invention will be described in more detail with reference to the accompanying drawings, in which:

Fig. 1 depicts an injection cartridge, known from the prior art, before injection.

Fig. 4 depicts the injection cartridge according to the invention after injection, but before you start cleaning.

Fig. 5 depicts the injection cartridge according to the invention in the process of washing.

Fig. 6 depicts the injection cartridge according to the invention after flushing is complete.

Fig. 7 depicts a dual-chamber injection cartridge according to the invention before it is prepared for injection.

Fig. 8 depicts a dual-chamber injection cartridge according to the invention.

Fig. 9 depicts a dual-chamber injection cartridge according to the invention after injectable drug re-obtained in the anterior chamber.

Fig. 10 depicts a dual-chamber injection cartridge according to the invention during an intermediate stage after re-obtaining or preparing an injectable drug.

Fig. 11 depicts a dual-chamber injection cartridge according to the invention, when prominy solution flows into the chamber formed behind the moving wall.

Fig. 12 depicts a two-chamber cartridge according to the invention, prepared for injection.

Fig. 13 depicts a dual-chamber injection cartridge according to the N. according to the invention after the injection, but before washing.

Fig. 15 depicts a dual-chamber injection cartridge according to the invention after flushing is complete.

In the drawings, the injection cartridge is depicted only schematically, since the design of these cartridges in detail. Similar parts in the drawings are marked with the same number of positions. It should also be noted that the drawings serve only to illustrate the invention and in no way limit its scope.

In Fig. 1 schematically shows a known single-chamber injection cartridge when the introduction of injectable drug has only just begun. Injection cartridge contains cylinder 1 filled with liquid injectable preparation 2. The chamber filled with this drug 2, sealed at its rear end by the piston 3. At its anterior end of the cartridge has an outlet 4, while in the depicted embodiment, this pipe is connected with a tube 5, which is ultimately connected to the injection needle or cannula 6. Near the injection needle 6 is device 7, such as surgical adhesive tape (plaster) to fasten the needle 6 on the patient's skin. The introduction of injectable drug 2 start, ka>In Fig. 2 depicts a known cartridge after taking the medicine. The piston 3 is in the most forward position in the cylinder 1, and essentially all injectable drug is expelled from the cartridge. However, some amount of the drug left in the dead space formed by the outlet pipe 4 and pipe 5. This amount of the drug cannot be used by the patient and is usually lost. These losses can be very significant from an economic point of view, when assigned very expensive drugs for injection, such as growth hormones and some peptides. As stated above, up to the present time no suitable way to correct or compensate for this deficiency.

In Fig. 3 depicts a single chamber cartridge for injection according to the present invention before injection. As described above, the injection cartridge contains the cylinder L, in which is enclosed liquid injectable drug 2, and the chamber containing the drug, sealed at its rear end of the front piston 3. On the front end of the cartridge also includes an exhaust pipe 4 connected to the injection needle or cannula 6 through the tube 5.

However, the cylinder 1 stretches Ilona rear piston 10. In addition, near the front end of the cartridge is a liquid bypass connection 11. This bypass connection can be done in several different ways, well known to specialists. For example, it may include a channel made in the inner wall of the cylinder 1, or any other modification of the inner wall of the cylinder. Liquid bypass connection may also be a so-called negative type, in which the internal cavity of the cylinder is narrowed, so that the piston being in it, will deform. The main task you must perform the liquid bypass connection is that the piston 3, while in the position referred to by-pass connection, and does not completely seal or sealing mentioned inner wall.

In Fig. 4 shows the single-chamber injection cartridge according to the invention after essentially all injectable drug is expelled from the cartridge. The front piston 3 is in the most forward position in the cylinder 1, but in a dead space formed by the exhaust pipe 4, the pipe 5 and the liquid bypass connection 11, is still a small amount of an injectable preparation 2 the way the trajectory of the fluid flow passes from the chamber behind the front piston 3 mentioned around the front of the piston in the dead space in front of him.

In Fig. 5 depicts a single-chamber injection cartridge according to the invention after the start of washing. The rear piston 10 now moves forward, so that the rinsing liquid 9 should flow through the liquid bypass connection 11 to the piston 3 to the outside in a dead space formed by the exhaust pipe 4 and the pipe 5, thus displacing injectable drug in this dead space, through the injection needle or cannula 6, the patient.

In Fig. 6 depicts a single-chamber injection cartridge according to the invention after the rinsing liquid extruded from the cartridge. The rear piston is now abuts and is adjacent to the front piston 3, and the exhaust pipe 4 and the tube 5 is, in essence, only rinsing liquid 9. Essentially all injectable drug is now injected through the injection needle or cannula 6 with the main part of the washing liquid, as shown by the drop of 12.

In Fig. 7 depicts a dual-chamber injection cartridge according to the invention. This cartridge comprises a tubular, cilindri the UNT 24 injectable drug and the rear chamber 23 contains a liquid component 25 of the above mentioned injectable drug. Front camera 22 and the rear chamber 23 separated by sealing a movable wall or partition 26, and the rear chamber 23 is sealed at its rear end of the front piston 27. In the inner wall of the cylindrical body of the cartridge is made liquid bypass connection 28. On the front end of the cartridge is the discharge port 29, through which displaced instituty the drug. The outlet 29 is connected to the injection needle or cannula directly or through a tube, as shown in Fig. 1-6. For clarity, these details are not shown in Fig. 7-15.

The above signs two-chamber cartridge for injection according to the invention are well known as described in the prior art injection cartridges dual-chamber type.

Cylindrical body 21 of the injection cartridge of the present invention is held at the front piston 27, thus forming an additional or auxiliary chamber 30. This chamber 30 filled with the rinsing liquid 31 and sealed at its rear end by the rear piston 32. In addition, the front end of the cartridge is liquid bypass connection 33.

In Fig. 8 shows a two-chamber Vigna wall 26 is located at the position of the liquid bypass connection 28, and the part or portion of the liquid component is able to flow from the rear chamber 23 in front of the camera 22. Thus the liquid component 25 is mixed with the solid component, dissolving or suspending it and forming a ready-to-use injectable drug. Rinsing liquid 31 still lies in the additional chamber 30 between the front piston 27 and the rear piston 32.

In Fig. 9 depicts a dual-chamber injection cartridge according to the invention, after all of the liquid component is pushed in front of the camera 22 for the formation of injectable drug 34 together with the solid component. The front piston 27 is adjacent to the movable wall 26, and the rear camera is now temporarily not exist. By moving the rear of the piston 32 and the front piston 27 secondary camera 30 with a wash liquid 31 is moved forward, but does not feel the impact otherwise.

In Fig. 10 depicts a dual-chamber injection cartridge according to the invention after the rear piston 32 and, consequently, also the front piston 27 and the movable wall 26 is pushed forward so that the said front piston 27 and the movable wall 26 serves liquid bypass connection 28. In that the cartridge according to the invention after as the rear piston is pushed forward so that the front piston 27 is at the position of the liquid bypass connection 28. When moving forward of the rear piston 32 rinsing liquid 31 begins to flow around the front of the piston 27 in the space between the movable wall 26 and the front piston 27, thus creating again rear camera 23 and filling her wash liquid 31. Injectable drug 34 in the anterior chamber 22 also moves forward, but otherwise has no effect.

In Fig. 12 depicts a dual-chamber injection cartridge according to the invention after the rinsing liquid 31 is pushed into the rear chamber 23. The rear piston 32 is now adjacent to the front piston 27, and the two piston now operate as a single piston, while still secondary camera 30 now disappears.

In Fig. 13 depicts a dual-chamber injection cartridge according to the invention, after the front and rear pistons 27 and 32 and, consequently, also the movable wall 26 is pushed forward so that the front camera 22 is now fully filled injectable drug 34. This drug can now be extruded from the cartridge through the outlet 29 to start inye the dual-chamber injection cartridge according to the invention after as essentially all injectable drug 34 extruded from the cartridge and put the patient. Now in the dead space of the cartridge in front of the movable wall 26 and the exhaust pipe 29, and possibly in the tube (not shown) to the injection needle or cannula has left some part of the above mentioned drug. When the movable wall 34 is in its most forward position, it is located at the position of the front liquid bypass connection 33, which this begins to act and allows wash liquid 31 to bypass this movable wall 34 and flow outward in a dead space in front of her. In moving forward, the United front and the rear of the pistons 27 and 32 of the rinsing liquid 31 will be pushed through the liquid bypass connection 33 and pushed out of the cartridge through the outlet 29 to move the remaining injectable drug and its extrusion through the injection needle or cannula into the patient. Thus you can see that all injectable drug to be administered to the patient and will not be lost.

In Fig. 15 depicts a dual-chamber injection cartridge according to the invention after the rinsing liquid is expelled through the exhaust patruleasa connection 33 is not valid. Injection of the cartridge is now complete.

Receiving an injectable drug and subsequent washing of the single-chamber injection cartridge, and the preparation, introduction and flushing of the dual-chamber injection cartridge according to the invention is carried out by vtalkivaniya piston (Fig. 3-6) or the rear of the piston 32 (Fig. 7-15) through piston rod. The piston rod can be moved forward by means of a simple directed axially forward pressure by a screw mechanism, or a combination of both. Specialists are well known devices and devices for performing such a move, therefore no need to describe them in detail.

Features dual-chamber injection cartridge according to the invention are the following:

Injection cartridge usually give the patient in the position shown in Fig. 7. When the cartridge is prepared for use, the user is directed forward pressure, i.e., presses on the piston rod (not shown) of the rear piston. This pressure is transmitted through the essentially incompressible fluid 25 and 31 in the rear chamber 23 and the rear end of the chamber 30, respectively, so that the movable wall 26 and the front piston 27 also takeouts ranovitsa current and allows the liquid component 25 to flow around the mentioned movable wall 26 for mixing with the solid component in the anterior chamber 22. This solid component 24 is soluble or forms a dispersed phase in the liquid component 25, forming injectable drug 34.

When you move the front piston 27 forward so that the entire liquid component is pushed in front of the camera 22, the front piston 26 abuts and is adjacent to the movable wall 26. Upon further forward movement of the rear piston 32 will move forward the front piston 27 and the movable wall 26 until such time as mentioned the front piston 27 reaches the position of the liquid bypass connection 28. In this case, the bypass connection 28 becomes valid again, and the rinsing liquid can flow around the front of the piston 27. Upon further forward movement of the rear piston 32 of the front piston 27 will remain stationary while the movable wall 26 will be pushing forward, while the rinsing liquid 31 will bypass the front piston 27 and to fill the space formed between the said movable wall 26 and said front piston 27. When all the wash fluid will be pushed into the said space, the rear piston 32 will rest against the front piston 27, adhering to it, and upon further forward movement of both the piston will act as a single mixed injectable drug 34 through the exhaust pipe 29, connected to the injection needle or cannula, not necessarily through the tube. Injection needle or cannula is now connected to the patient, and it is possible to carry out the enforcement of these injectable drug.

After completion of the injection movable wall 26 is in the most forward position in the Chuck body 21, while essentially all injectable drug is expelled from the cartridge. However, in dead space, including the space in front of the movable wall 26, an outlet 29, attached to the tube and injecting the needle, there is still some part of the drug, which cannot be used by the patient, unless special arrangements according to the invention.

In this extended position of the movable wall 26 is located at the front of the liquid bypass connection 33 so that the trajectory of the stream of wash liquid passes around the mentioned movable wall. Additional pressure forward on the United pistons 27 and 32 will now provide the possibility of wash liquid 31 to flow around the movable wall 26 and out the discharge port 29 and attached to the tube, the needle or cannula. While rinsing liquid 31 will be Eubac 29 and the tube was filtered. This loss injectable drug. Treatment is complete when the displacement of the cartridge of the entire washing liquid.

The injection cartridge is usually placed on the holder so as to facilitate its use in the process of injection. These holders are also conventional and well known in the art. Injection cartridge according to the invention does not require any significant structural changes in the known holders; small changes may be necessary to negotiate a greater length of the cartridge front and the bypass connection, but it is within the competence of specialists. For the manufacture of injection cartridges according to the invention uses the same materials as for the known injection cartridges, for example, glass and various plastics and rubber or rubbers. So, the cartridges having a front chamber containing liquid product, and an additional chamber containing wash liquid, the front piston may be made of any elastic material, preferably rubber. However, when using the cartridge according to the invention for lyophilization to obtain a solid component, a movable wall IU what nicemedia for water vapor. Suitable material is butyl rubber, it is preferably halobutilic, as, for example, CHLOROTHALONIL or bromatology rubber. When using a cartridge according to the invention for lyophilization cylinder cartridge must be made of resistant material in order better to withstand low pressure and temperature used in the process of lyophilization. Suitable material is glass.

It is important that the volume of the wash liquid was sufficient for washing the dead space and displace the remaining injectable drug and injection on the patient. It is established that the amount of wash liquid should be at least two, preferably three times more than the combined volume of space of the cartridge in front of the front piston or movable wall is in its most forward position and space in the exhaust pipe up to the injection needle or cannula. This provides the effect of washing.

It is established that the injection cartridge according to the invention can be used with any medication that can be used in conventional injection cartridges. As an example we can mention therapeutic proteinases drugs in particular those produced via recombination of DNA. Typical examples are growth hormones, some peptides, anticancer drugs, vaccines, interleukins, monoclonal antibodies, tissue plasma activator (tPA), erythropoietin (EPO), urokinase, streptokinase, heparin or low molecular weight proteins person. In particular, proteins person include factor VIII, factor IX, or antithrombin III, obtained by recombination technology DNA. For these drugs the exception of the loss of great economic importance.

Suitable liquid preparations include solutions containing proteins person, as, for example, factor VIII, factor IX and antithrombin III, with at least one stabilizing agent such as a surfactant. Suitable solid components injectable drug include lyophilized proteins person. Preferably the factor VIII obtained by recombination technology DNA.

Injection cartridge of the present invention are useful for parenteral treatment, as, for example, subcutaneous, intramuscular or intravenous injection, preferably intravenous injection. More prefer the Oh and the injection needle or cannula, essentially, all injectable drug. Injection cartridge of the present invention is useful for the purpose of any proteins person, preferably lyophilised proteins.

The method of introduction of the liquid drug from the injection syringe of the present invention is convenient to use in parenteral treatment, as, for example, subcutaneous, intramuscular or intravenous injection, preferably intravenous injection. More preferably, the method of introduction of the liquid product is used for washing the exhaust pipe connected to the tube and the injection needle or cannula, essentially, with all injectable drug. The method of introducing the liquid preparation of the injection cartridge of the present invention suitable for use with the introduction of any human protein, preferably lyophilized protein.

The wash liquid may be any liquid which is compatible with an injectable drug and does not cause any harmful effects in the treatment of the patient. Experts know a lot of such liquids, for example the already mentioned physiological saline.

In the above description sobretudo examples only and are not intended to limit the scope of the invention, no way. Other variations and modifications of the present invention are possible within the stated claims.

1. Injection cartridge to displace the liquid drug through the outlet located on the front end of the cartridge, by moving the piston located in the cartridge, characterized in that the rear of the front piston to eject the drug is a secondary camera in the cartridge containing wash liquid, the chamber sealed at its rear end by the rear of the rolling piston and the front end of the cartridge is a liquid bypass connection is made with the possibility of the expiration of the washing liquid around the front of the piston and out through the exhaust pipe connected to the tube and the injection needle or cannula, for washing the exhaust pipe in the front position of the piston in the forward position.

2. Injection cartridge under item 1, characterized in that the volume of wash liquid is equal to at least twice the combined amount of any space in the cartridge in front of the front piston and the space in the exhaust pipe.

3. Injection cartridge under item 1 or 2, characterized in that the liquid Bai is decomposing the, that the liquid bypass connection is made in the form of a channel in the inner wall of the cartridge or in other modifications of the inner wall.

5. Injection cartridge according to any one of paragraphs.1 to 4, characterized in that the movable wall between the front and rear cameras are made of butyl rubber.

6. Injection cartridge according to any one of paragraphs.1 to 5, characterized in that the cylindrical body is made of glass.

7. Injection cartridge according to any one of paragraphs.1 - 6, characterized in that the liquid product contains protein man.

8. Injection cartridge to displace the liquid drug through the outlet located on the front end of the cartridge, by moving the piston located in the cartridge, characterized in that the rear of the front piston to eject the drug is a secondary camera in the cartridge containing wash liquid, the chamber sealed at its rear end by the rear of the rolling piston and the front end of the cartridge is a liquid bypass connection is made with the possibility of the expiration of the washing liquid around the front of the piston and out through the exhaust pipe, at the same time rinsing the said pipe at the position of the front is of dnaa chamber contains a solid component of injectable drug while the rear camera is a liquid component of the drug, cameras separated by a movable wall, and in which the rear fluid connection is made in the inner wall of the cartridge with the possibility of the expiration of the liquid component around the movable wall to be mixed with the solid component, the rear camera is sealed at its rear end through the front of the piston, secondary camera for wash liquid is located in the holder behind the front of the piston and is sealed at its rear end by the rear of the rolling piston.

9. Injection cartridge under item 8, characterized in that the volume of wash liquid is equal to at least twice the combined amount of any space in the cartridge in front of the front piston and the space in the exhaust pipe.

10. Injection cartridge under item 8 or 9, characterized in that the liquid bypass connection at the front end of the cartridge is made in the outer wall.

11. Injection cartridge under item 8 or 9, characterized in that the liquid bypass connection is made in the form of a channel in the inner wall of the cartridge, or any other modification of the inner wall.

12. Injection cartridge according to any one of paragraphs.8 to 11, characterized in that final paragraph is p. 8 - 12, characterized in that the solid component is liofilizirovannam protein man.

14. Injection cartridge according to any one of paragraphs.8 to 13, characterized in that the movable wall between the front and rear cameras are made of butyl rubber.

15. Injection cartridge according to any one of paragraphs.8 to 14, characterized in that the cylindrical body is made of glass.

16. The method of introducing liquid drug to a patient of the injection cartridge by displacement of the drug through the outlet located on the front end of the cartridge, wherein the drug displace through the front of the piston, pushing back the piston, which together with the front piston seals additional chamber containing wash liquid to create a liquid bypass connection, when the front piston is in the forward position so that the rinsing liquid can flow around the front of the piston and out through the exhaust pipe for rinsing the pipe from the remnants of the drug.

17. The method according to p. 16, wherein the injectable drug displace through the tube and the injection needle or cannula.

18. The method according to p. 16, characterized in that the volume of washing the eating and space in the exhaust pipe.

19. The method according to p. 16, characterized in that the solid component is liofilizirovannam protein man.

20. The method according to p. 16, characterized in that the movable wall between the front and rear cameras are made of butyl rubber.

21. The method according to p. 16, characterized in that the cylindrical body is made of glass.

22. The method according to any of paragraphs.16 to 21, characterized in that the rinsing liquid is a physiological saline solution.

23. The use of injection cartridge according to any one of paragraphs.1 - 7 for intravenous injection.

24. The use of injection cartridge according to p. 23 for intravenous injection through the exhaust pipe connected to the tube and the injection needle or cannula.

25. Application under item 23 or 24 for internal injection of protein man.

26. The use of injection cartridge according to any one of paragraphs.8 - 15 for intravenous injection.

27. The use of injection cartridge according to p. 26 for intravenous injection through the exhaust pipe connected to the tube and the injection needle or cannula.

28. Application under item 26 or 27 for intravenous injection of the protein man.

 

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