Fill medicine syringe device

 

(57) Abstract:

Use: medicine and medical equipment, filling medication syringe and maintain its sterility at all stages before use, protect from intentional unauthorized use. The inventive device includes a cylinder 1, designed to be attached needle plot 2 put on his cap 3, the piston rod 9 of the piston and the sealing device 16 in the form of a tube 17 of the shrinkable film, which is pulled down over the area extending from the cap 3 along the cylinder 1 to the base of the head 12 of the rod 9 of the piston. The sealing device is subjected to shrink under heat so that it will tightly adhere to specified elements, ensuring that the cylinder 1 filled with the medicinal product 8, the piston 7 and the piston rod 9 of the piston is isolated from the ambient air. The cylinder 1 has a label 11, which is positioned in the area between the front and rear ends of the piston 7 to specify a limit, beyond which he should not be nominated. 1 C.p. f-crystals, 4 Il.

The invention relates to filled drug device syringe, which has a cylinder filled with a specified number leaderswho use, which contains a specified amount of drug contained in the cylinder, is widely used not only because of the saving of the time required to transfer medication from an ampoule into the cylinder before injection, but also because of the exclusion of the potential danger of infection by pathogenic bacteria and viruses due to repeated use of the device.

Such a syringe device has the following basic design: the cap is put on intended for attaching the needle area on the front end of the cylinder, and a piston inserted into the cylinder from the rear end so that the front of the piston is formed a closed space, in which is placed a set number of medical drug. As for injection, it is only necessary to remove the cap and attach the needle, the device has the advantage of simplicity in use.

However, the device raises the problem of its simple construction: it consists in the fact that no bridging means, in addition to the cap worn with the possibility of withdrawal designed to be attached needle plot, is not provided, so if you do not have the right man welive the state drug then check that it was done or not, is impossible until and unless cleared cap.

The second problem with this product occurs because it cannot be sterilized or disinfected immediately before use, which creates a sharp contrast with another type of conventional devices, syringes, where medicines in ampoules. Under such circumstances, it is necessary to ensure that the unit in question, it was possible to sell and store in a sterilized atmosphere, starting from the moment of filling the drug in sterile conditions to a physical use; to meet this need, the devices must be packing in airtight packaging, and strictly control the handling and shipping operations, and it requires cumbersome procedures.

To solve the first of the above-mentioned problem, the present applicant previously proposed to cover the front end part of the cylinder and the hollow cap, solid sealing device made of shrinkable film, which undergoes shrinkage when exposed to heat, coming into direct contact with on the go belt part (see official Bulletin describing not the examined published Japanese utility model applications Hei-3-101960).

According to this proposal, the sealing device prevents unauthorized removal of the cap and move the piston cannot because the filled drug the closed space (in vacuum). This gives the consumer the advantage of getting rid of anxiety, because it can make sure that the device of the syringe is properly sealed before applying.

On the other hand, and the inside of the cylinder at the base end, and a piston rod remain open and create zones where possible the deposition of bacteria, viruses, and particles of dirt or dust. To resolve this problem, you need a device for a syringe to wrap airtight packaging tool. Therefore, we have to develop a means of solving the above-mentioned second problem.

The sealing device proposed is not the examined published Japanese patent application for utility model Hei 3-101960 mentioned above, is associated with another problem, namely, that the cap should undergo sufficient shrinkage to ubezpieczeniowe removing the sealing device with the cap of the cylinder, and then again install it. To meet this need, you can either put heat at high temperatures for a short period of time or at relatively low temperatures for a long period, but then may provide an undesirable impact on the prisoner in the cylinder medication or appearance caused by thermoresistive mismatch of the sizes of the cylinder of the piston and the cap, which will cause the formation of gaps between these parts, which can become a potential source of leakage of the drug.

If located in the cylinder the drug is a liquid of high viscosity, it is necessary to use a rather thick needle, so that it is possible to smoothly inject the drug, which is needed. To meet this need, in practice, often carried out by suction usual means in the cylinder through a needle and inject it to the patient, thereby softening the pain can test the patient during the subsequent injection of the drug at the site of its introduction.

In some cases there is also a need in the entered drug in liquid form immediately before injection contained in the cylinder of a drug in liquid form, or adding a solubilizer immediately before injection contained in the cylinder of the drug in powder form, due to which the drug becomes liquid.

In those cases, when another drug or a similar tool in liquid form (which here will appear under the collective name of the "more liquid") should be added to the previously placed in the cylinder to the medicine, you should move the piston in a direction corresponding to pulling it from the cylinder. However, when there is provided the specified invention of the syringe device of this type, which is filled with the specified quantity of the medicinal product, on the cylinder there is no calibration for reading volume of the drug, because of the need for such calibration no. Instead, the amount of extension of the piston is determined visually to estimate the number of additional liquid that you want to suck.

Under such circumstances, even if the piston is designed so that is longer than a specified distance, at which it should move to absorb additional fluid, the front end of the piston, which is specified in the drug product, if the piston moves at a distance whose magnitude is larger than the required value.

The region inside the cylinder, which are in contact with the piston and the drug can be maintained sterile during the entire period of time from the stages of delivery storage until the beginning of use. The area inside the cylinder behind the piston can also be maintained sterile during shipping and storage, since the cylinder is supported in the conditions of the sterile packaging with sealing devices; however, if the seal is opened for use of the syringe, it may be chance for penetration of pathogenic bacteria and viruses on the inner surface in this region. If the piston is shifted to the point where its front end reaches the area of contaminated sediments pathogenic bacteria and viruses, the drug may enter into contact with them, so will have the potential contamination of the patient during the injection of contaminated drug.

Thus, the first problem to be solved by using the present invention, is that normal syringe, which has colp Unger, inserted into the cylinder from the rear end, in the sealing means, which could easily be applied when determining that the above-mentioned disadvantages and thereby solving two problems preventing unauthorized use of a syringe and stored sterile at all stages before it is used.

The second problem is solved by means of the present invention, is that normal syringe, even when using a piston of considerable length, does not exclude the potential risk that when the suction for the injection of another drug in liquid form, other than that contained in the cylinder previously, pathogenic bacteria or viruses can contaminate the drug, which can subsequently be administered to the patient.

Therefore, the first technical object of the invention is to ensure that the filled drug device syringe can be maintained sterile at all stages up to the use that it is protected from unauthorized use, its easy to pack and what you can protect the drug to save it in a sustainable prominent fluid, such as an anaesthetic agent, another drug in the form of liquid or a solubilizer, can be sucked before injection of appropriate aseptic technique, use a filled drug device syringe.

The first technical problem of the invention can be solved with the help of filled drug device syringe, which has a cap, put on intended for attaching the needle area on the front end of the cylinder, and which has a piston with a given dose of a drug contained in the cylinder, characterized in that the cap, cylinder, and piston rod, protruding back of the cylinder and the base cylinder closed hollow sealing device made of shrink film and has undergone shrinkage when exposed to heat, so that it firmly adheres to said elements, and the basic cylinder and piston rod has a flange on the front end and acting out the plot, the diameter of which increases from the flange back, and the rear end of the sealing device combined with acting out the plot.

With this design the proposed device of the syringe is sealed hermetically in all what redstem sealing device, which was designed to tightly adhere to these zones as a result of shrinking, due to which the device for a syringe can be supplied and stored at effectively isolated from the ambient atmosphere to the interior of the cylinder and the base end and the piston rod. To use the device for a syringe, the sealing device tear in right and left directions, so that it can be removed from the cylinder.

To solve the second technical task of the present invention, the device of the syringe preferably provide the mark on the cylinder, which is located in the area between the front and rear ends of the piston, when it is set to a predetermined position in the cylinder, and which specifies the limits for which one should not raise the piston. This arrangement ensures that when the cylinder suck medication through the needle, which is attached to the cylinder after removing the sealing device and the cap, the piston can slide forward to the point in which its front end does not go beyond the mark. In the result, it is possible to introduce the drug to the patient, essentially, filled, without contact with any part inside the cylinder behind the rear is akrita sealing device, corresponding to one of the embodiments of the invention, a front view, section view, and Fig. 2 the sealing device, front view, section view, and Fig. 3, the syringe device corresponding to another variant embodiment of the invention, side view, section view, and Fig.4 is the same, version, front view, partial cross section of a sealing device, not shown), in which the cylinder is provided by a label indicating the limits which should not push the piston, and an auxiliary mark.

In the drawings denote: 1 cylinder of the syringe; 2-designed to be attached needle section; 11-label; 24 auxiliary label; 8 - drug; 3 cap; 7 piston; 9 the piston rod; 12 - basic cylinder and piston rod; flange 13; 14 acting out the plot; 10 annular rib; 16 sealing device; 17 tube; 20 - torn tape.

Embodiments of the present invention is described below with reference to the accompanying drawings. In Fig.1 shows the cylinder of the syringe, indicated as a whole by the number 1. Designed to be attached needle plot 2 projects from the front end of the cylinder 1. The cap 3 is put on intended for insertion needle section 2. Cap 3, which is usually violenoe hole 6, which opens in a surface on the base end. The base 4 has essentially the same diameter as the outer diameter of the cylinder 1. The cap 3 is put in such a way that is designed to attach needle section 2 is pressed into the installation hole 6 and the surface on the base end of the base 4 is in actual contact with the surface on the front end of the cylinder 1.

The piston 7, is usually made from butyl rubber, is inserted into the cylinder 1 from the rear end of the specified position with the provision of liquid-proof, with a specified number of drug 8 is contained in the closed space formed by the cap 3 and the piston 7 in the area closer to the front end of the cylinder 1.

The piston 7 is attached to the front end of the rod 9 of the piston through, for example, a threaded fitting. To ensure improved sealing of the medicinal product 8, the annular rib 10, which are in direct contact with the inner surface of the cylinder 1, is provided on the front end, back end and in the middle of the piston 7, and at the same time, the piston is designed so that is of considerable length. However, it should be noted that this is on the drug 8. It should also be noted that the piston is designed to be longer than the distance it needs to move to additional suction fluid. Mark 11 in the form of a colored thin lines extending in the circumferential direction, are provided on the surface of the cylinder 1 in the area between the front and rear ends of the piston and indicates the limit beyond which one should not raise the piston with the purpose of additional suction fluid.

The rod 9 of the piston extends back from the cylinder 1 and has a base head 12 on the rear end. The base head 12 has such a structure that contains the flange 13, a bit larger in diameter than the piston rod 9 of the piston, the speaker output section 14, having essentially the same diameter as the rod 9 of the piston on the front end and increasing in diameter towards the rear end, and glanceability pressure section 15.

Next with reference to Fig.2 will be described sealing device 16, which is the most salient feature of the invention. The sealing device comprises a tube 17 and torn tape 18. The tube 17 is made of transparent shrink film, which in turn is made of synthetic resin, such as poly(vinyl the inu, as the total length of the device in question syringe, and is slightly larger in diameter than the rear flange 19 provided around the cylinder 1.

Torn tape 18 is attached by bonding to the inner surface of the tube 17 from one end to the other in the longitudinal direction. Tube 17 is subjected to a preliminary drawing, so that she could undergo shrinkage to a predetermined size in the longitudinal and circumferential directions after application of heat.

To create a sealing device 16, an elongated heat shrinkable film attached tear strip 18, is cut into segments of desired length and is wrapped around itself to form a tube 17. One end of the tear tape 18 stands for the end surface of the tube 17 forming designed to start opening the seal eyelet 20, while the other end of the tape 18 is made in the form of a concavity 21, ensuring complete rupture of the tube.

Designed for the beginning of the opening of the eyelet tape, which is attached to the sealing device 16 need not be a projection from one end of the tube 17, as shown by the position 20 in Fig.2. Instead, on both sides of the tape can be cut con is I easy clip designed to start opening the compacted ear, it ensures complete rupture of the tube.

If necessary, it is possible to accurately specify the position intended for the beginning of the opening of the sealing loops and the direction of opening. To do this, unfold the strip can include one or more labels (e.g., arrows), indicating the position of the loops and the direction of opening of the seals located in the region of the tube to which is attached a torn tape.

To install the sealing device 16 on top of the cylinder 1, it is first positioned so that intended to start opening the seal eyelet 20 coincides with the position of the cap 3, and then the device is worn by sliding over the top of the cylinder so that it extends from the cap 3 through the rod 9 of the piston for the rear flange 19 to the base of the head 12. When the sealing device is heated by a suitable heating means such as high frequency radiation, infrared heater, pulsed thermal welding or hot air flow, the device undergoes shrinkage, and the front end is bent toward the center of the cylinder along the belt 23 of the cap 3, while the remainder passes along the base 4 of the cap 3, the cylinder 1, the rear flange 19 and the rear is section 14 of the base head 12. Having undergone any such shrinkage sealing device 16 tightly adheres to these elements and details of the device in question syringe.

In the above embodiment, the cap 3 worn over intended for insertion needle section 2 so that the latter is pressed into the installation hole 6 in the cap, and at the same time, the front end surface of the cylinder 1 is held in direct contact with the surface of the base end of the base 4 of the cap, having essentially the same diameter as that of the front end surface. These two design features of the cap 3 closes designed to be attached needle section 2 with a high degree of air leakage. Another distinctive feature is that the sealing device 16 has a front end, which are in direct contact with the belt 23 of the cap, and this further increases the tightness (leakproofness) intended for insertion needle section 2. In addition, the rear end of the sealing device 16 is in direct contact with the speakers out area 14 of the base head 12, thereby not only what is in airtight atmosphere, preventing the deposition of contaminants such as pathogenic bacteria, viruses and particles of dirt and dust.

Therefore, if the filling of the cylinder 1 drug 8 in a sterile atmosphere is accompanied by sliding of the sealing device 16 over the cylinder in the same sterile atmosphere and thermal shrinkage of the device so that it comes into direct contact with the cylinder, then any portion of the syringe, which may come in contact with the medicinal product 8 can always be kept sterile by a sealing device 16. The result can either be simplified or completely eliminate the entire packing operation of the syringe for delivery and storage.

As already mentioned, the rear end section of the sealing device 16 is supported in direct contact with the speakers out area 14 of the base head 12. Since the speaker output section 14 increases in diameter towards the rear end of the head, the sealing device 16 will be after the shrinking reliably stick to the cylinder as it approaches its rear edge, ensuring thereby further increased tightness (leakproofness).Udet to break the tightness (leakproofness) in this field.

It should also be noted that, since the sealing device 16 has the ability to stick to the cap 3 and the base cylinder 12, there is no need for direct contact of the device with the region located between these elements. This staging area is necessary to apply heat only at relatively low temperatures within a short period of time, and this is done not only in order to avoid any harmful thermal effects on the drug 8, but in order to eliminate any concerns about possible leakage of the medicinal product due to thermal expansion mismatch in size between the different parts of the syringe.

It should also be noted that the sealing device 16 closes the entire portion of the cylinder 1, and the entire portion of the rod 9 of the piston, except for the portion of the base head 12; therefore, the sealing device 16 also has damping and reinforcing abilities, because it reduces the possibility of damage after a stroke, which may be caused, for example, random drop, and at the same time, the glass cylinder 1 is resistant to damage the movement of the rod 9 of the piston is almost impossible, and it is protected from any unauthorized attempts to push or pull, due to which the medicinal product 8 may be located in a confined space in a stable state.

To use the syringe that is designed to start opening the seal, the eye 20 of tearing tape 18 grab with your fingers or tweezers and pull them back, due to which the tube 17 is torn along the tape 18; after this, remove the cap 3, is put on the needle cylinder 1 and, if necessary, push the piston 7 at the point where the front end does not go beyond the markings 11, sucking in the cylinder additional fluid, such as an anaesthetic agent for injection.

In the variant shown in Fig.1, the base head 12 of the rod 9 of the piston has a speaker output section 14. Instead, the base head 12 may be made in the form of a thick disk, as shown in Fig.3; the advantage of this variant lies in the fact that when the sealing device 16 undergoes shrinkage, it is possible to carry out the fit over the base of the head 12, ensuring good air tightness (leakproofness), and the concavity 21 is located on the outer circumference of the head.

Sealing condition is to the other so the device can be broken along the line of these holes perforation. Still, from the point of view of air permeance (tightness), torn tape 18 is preferable holes perforation.

In Fig.4 shows a filled drug, the syringe device corresponding to another variant implementation of the present invention. Below the second variant of implementation will be described in detail and with reference to Fig.4.

The piston 7 is designed so that it is longer than the distance it must move to additional suction fluid, such as an anaesthetic agent, drug or solubilizer that is different from the drug, already contained in the cylinder 1. The piston 7 has an annular rib 22, performed not only at the front and back ends, but in the intermediate zone so that all these edges are in close contact with the inner surface of the cylinder 1, thereby the role of sealants.

In the presence of the piston 7 that is installed in the specified position, the cylinder 1 has also mark 11 provided in the area between the front and rear ends of the piston 7; mark 11 is a color line, p is t, which can suck, namely, to specify a limit, beyond which one should not raise the front end of the piston 7. In other words, marking 11 warns the user that there may be two possibilities, if you remove the cap 3 and the attached needle for sucking extra fluid, the piston 7 are putting forward a point lying outside the specified mark 11: firstly, it is possible the absorption of excessive amounts of extra fluid, which can reduce the effectiveness of the contained drug 8 or cause harmful effects on the patient; secondly, the drug 8 may be contaminated with pathogenic bacteria, viruses or particles of dirt or dust that may adhere to the inner surface of the cylinder 1 in those areas, are located behind the position separated by a given distance from the rear end of the piston 7.

Therefore, the label 11 has an additional advantage is that the drug, such as an anaesthetic agent, the dose of which you need to enter the patient in accordance with his status, you can enter when the correct dosage, because the amount of absorption can be determined by the distance from the tag 11 to the n additional tag 24, function of which is to specify the standard or the minimum amount of additional liquid that can be sucked; therefore, pushing the piston 7 relative to the auxiliary label 24 in accordance with the condition of the patient, can be sucked and to enter the patient an appropriate amount of additional liquid. Additional label 24 is not necessarily the only, it is possible to provide two or more labels.

It should be noted that the label 11 and the auxiliary label 24 in any case can not be reduced to thin lines, and can consist of any other symbols, such as arrows or dots. Needless to say, these labels can be accompanied by indications of their meaning, such as indicating that they represent a limit that should not exceed the piston 21, or may be accompanied by a symbol indicating the volume or other parameters.

Therefore, if the device is a syringe, in which the hollow sealing device, pulled down over the area extending from the cap to the base end of which have been shrinking for sticking to these parts, not only the inside of the cylinder at the site near the base end, and a piston rod secured to and support the and the time from the moment of filling the medicinal product prior to use, through which the syringe can be hygienic even after its delivery and storage in a simplified packaging or no packaging. In addition, the consumer will not have to worry about the fact that people do not have the right to remove the sealing device, to falsify (replace) the drug in the cylinder and re-use sealing device. In addition, the sealing device can enter into direct contact with the required parts of the syringe, exposing the device is etched without harmful effects on the drug or without any leakage past, and this ensures high reliability of the quality of the device. Another advantage of the invention is that the sealing device is able to protect from impacts, not only provides enhanced security, but also fixes the piston rod in such a way that you can support contained in the cylinder of the drug at steady state.

If necessary, the surface of the cylinder in the region between the front and rear ends of the piston can include the tag to specify the limit that must not the substance of this composition is when the suction for the injection of additional fluid, such as a drug, other than those already existing in the cylinder, an anaesthetic agent or solubilizer, the probability of moving the piston to a point in which its front end is at the initial position of the rear end (i.e., when the piston is in a predetermined position), is excluded, ensuring increased safety due to the fact that no pathogenic bacteria, viruses or particles of dirt or dust on the inner surface of the cylinder will not contaminate the injected secondary fluid. The label gives another advantage in that additional fluid can be sucked in the proper amount, which contributes to the manifestation of its value, or that it can be injected to a patient without the risk of inflicting harm.

1. Filled drug device syringe containing the cap, put on intended for attaching the needle area on the front end of the cylinder, a piston inserted into the cylinder from the rear end at a desired position in the presence of a given dose of a drug contained in the cylinder, characterized in that the cap, Qili what device, made of shrink film and have undergone shrinkage when exposed to heat, so that it firmly adheres to the surface of these elements, and the base of the cylinder and piston rod has a flange on the front end and acting out the plot, the diameter of which increases from the flange back, and the rear end of the sealing device combined with acting out the plot.

2. The device under item 1, characterized in that the cylinder has a label, which is located in the area between the front and rear ends of the piston, when it is set to a predetermined position in the cylinder, and indicating the limit beyond which you should not move the piston.

 

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