WO2008020780A1

WO2008020780A1 - Disposable syringe 'variants'

Info

Publication number: WO2008020780A1
Application number: PCT/RU2006/000407
Authority: WO
Inventors: Ilya Nikolaevich Pavlov; Vladislav Anatolievich Kropatchev; Vladimir Mikhailovich Makarov
Original assignee: Ilya Nikolaevich Pavlov; Kropatchev Vladislav Anatoliev; Vladimir Mikhailovich Makarov
Priority date: 2006-08-01
Filing date: 2006-08-02
Publication date: 2008-02-21
Also published as: RU2006127590A

Abstract

The invention relates to medicine. The inventive disposable syringe comprises a body provided with a piston having a cavity, a locking unit and an arrester which are arranged therein. The internal side surface of the body is provided with a groove in which the locking unit comprising a catch with a clamp is disposed. A double-bit needle is fixed inside the body coaxially to a hole, which is formed in the lower part of the piston, and to the output hole of a nipple positioned in the centre of the body base. A support with an arrester is rigidly fixed to the top part of the needle. A spring element is located between the body base and the piston. A drug-containing capsule, above which a return pusher is mounted, is placed in the piston cavity. The external surface of the body is covered with an elastic protective envelope, whilst the base thereof is coated with a protective film. In the second embodiment of a syringe, the cup-shaped cavity of a piston is filled with a drug and is closed with a contractible membrane. A return pusher in the form of an elastic element containing a compressed gas is mounted on the membrane. Delimiters for perforating the pusher are fixed to the top part of the piston and a gas removing hole is embodied in the protective envelop and/or in the body base. In the third embodiment of a syringe, a drug-containing capsule is embodied in the form of a deformable container. A pusher,which is made of elastic material and the top part of which is fixed to a protective envelop, embraces the sides and the top of the capsule.

Description

Disposable syringe "options >> Field of invention

The invention relates to devices for subcutaneous and intramuscular administration of drugs intended for single use, both in medical institutions and at home without the involvement of medical personnel, including on their own. State of the art

In most cases, an injection requires special medical qualifications. However, in emergency situations, mass vaccination of the population, in the absence of a sufficient number of medical personnel, as well as with the systematic use of injections, it is necessary to have a cheap, simple and easy-to-use syringe design that allows self-injection of a drug without the need for special training. Also an important aspect is the presence of an automatically retractable and safely held needle after injection in the body of the syringe. This significantly reduces the risk of accidentally pricking a needle after an injection, which can be the cause of infection with dangerous diseases such as AIDS and hepatitis. It is also not unimportant to ensure that the patient does not see the injection needle either before, during or after the injection. This reduces the fear and tension of the patient, which can be expressed in increased pain during the injection procedure. This aspect can be especially important when using a syringe in pediatrics.

SUBSTITUTE SHEET (RULE 26) A disposable syringe is known, the device of which contains a housing in the form of a bellows, from one end of which a hollow pipe is made to secure the injection needle, and from the other, an internal protrusion, and a safety device made in the form of bushings and rings mounted on the pipe with a gap relative to each other. In this case, the sleeve is made with an axial hole, the diameter of which is larger than the outer diameter of the ring and is installed with the possibility of movement in the direction of the ring. In addition, the sleeve has grooves in which protrusions made on the ring are placed. (RU ÷ N ° 2033192, Cl. A 61 M 5/28, A 61 M 5/50, 2000)

However, the design of this syringe is complicated both in manufacture and in application and does not allow the use of a syringe without special training of medical staff.

A disposable syringe is also known (RU, JVs 2122440, class A61M5 / 50, 1998), comprising a tubular body made of a polymer material, inside of which there is a piston with a rod also made of polymer material, the base of which on the stem side contains a cavity in which an elastic sealing element made, for example, of rubber or a coil spring, and having the shape of a ring, and its outer diameter is larger than the diameter of the cavity.

The disadvantage of this design of the syringe is that it cannot be completely disabled after injection, as a result of which the syringe can be reused. The prototype of the claimed invention is a disposable syringe (RU, 2080881, CL. A61M5 / 50, 1997), containing a housing with a needle holder, a piston with a cavity is placed inside the housing, the rod of which is made in the form of a sleeve with

SUBSTITUTE SHEET (RULE 26) elastic petals, including internal recesses and external protrusions placed in the piston cavity with the possibility of contacting with the shoulder, and the stopper is located between the petals of the sleeve with the possibility of its movement into the internal recesses of the petals.

The use of this disposable syringe is difficult in situations where emergency injection is necessary in conditions that do not allow the withdrawal of the drug, as well as the necessary treatment of the skin. In addition, when working with a syringe, actions are required to collect the drug into the cavity of the syringe, release air from the syringe and needle and direct injection. For the inability to reuse the syringe, additional actions are required to violate the locking pin. The use of this syringe is difficult for the patients themselves and requires special training of medical personnel.

All of the above disposable syringes are not effective enough when used in situations where emergency injections are necessary under conditions that do not allow aseptic drug intake, as well as the necessary treatment of the skin. One of the main disadvantages of the aforementioned syringes is the difficulty of their use by the patients themselves and requires special medical training and sufficient manual dexterity, which, for example, is absent in patients with arthritis.

SUMMARY OF THE INVENTION

The objective of the invention is to develop a simple and cheap design of a disposable syringe, providing the opportunity

SUBSTITUTE SHEET (RULE 26) intramuscular and subcutaneous injections, not only in medical institutions, but also under any conditions requiring the use of injections, including at home, is easy and safe without the involvement of specially trained medical staff, with the exception of the risk of accidental needle pricking after an injection, as well as the possibility of repeated use a syringe.

The technical result of the invention is the arrangement of the structural elements of the syringe, its simplicity and safety of the injection, as well as the destruction of the locking and locking elements of the syringe after the injection, and the possibility of locking the piston and the needle inside the housing, eliminating the possibility of reuse of the syringe.

The task and the specified technical result is achieved by the fact that in a disposable syringe containing a housing inside of which a piston with a cavity is placed, a locking unit and a stopper, according to the invention, the inner side surface of the housing at the base is made with a groove in which the locking unit is mounted, including a latch with a latch, inside the housing is fixed coaxially to the hole formed in the lower part of the piston and the outlet of the fitting located in the center of the base of the body of a double-edged hollow needle, on which, in its upper part, a support is rigidly fixed, with a stator mounted on it, a spring element is installed between the base of the housing and the piston, while a capsule with medicine is placed in the piston cavity, over which a return pusher is installed, the housing is covered with an elastic protective shell on top, and its base with a protective film. In this case, the capsule with the medicine is made in the form of a deformable container. The stopper is made in the form of an elastic,

SUBSTITUTE SHEET (RULE 26) a hollow ring filled with gas and connected on one side to the lower part of the piston and on the other hand with a support, and the fitting along the perimeter is equipped with microneedles, and through holes are formed on the support, which are coaxially oriented to microneedles. The stopper can also be made in the form of processes attached at one end to the bottom of the piston, and the other to the needle support. The return pusher is made in the form of an elastic element formed by an elastic shell filled with compressed gas, while the bottom shell is made with a thickening. Between the base of the case and the protective film, a layer of an antiseptic drug is applied.

Another variant of a disposable syringe is a syringe containing a housing inside which a piston with a cavity, a locking assembly and a stopper are arranged, according to the invention, the inner side surface of the housing at the base is made with a groove in which the locking assembly is mounted, including a latch with a latch, coaxially fixed to the hole formed inside the housing in the lower part of the piston, covered with a protective film and the outlet of the fitting, located in the center of the base of the housing a double-edged hollow needle, on which, in a part of it, a support is rigidly fixed, with a stopper mounted on it, while the piston cavity is bowl-shaped, filled with medicine and closed by a compressible membrane fixed along the perimeter of the piston cavity on which the return pusher is mounted, in the form of an elastic element formed by an elastic shell, filled with compressed gas, and attached on top to the elastic protective shell covering the housing, pointed stoppers are fixed in the upper part of the piston to pierce the return pusher, and containment and / or

SUBSTITUTE SHEET (RULE 26) the base of the housing has an outlet for discharging gas, while the base of the housing is covered with a protective film. The stopper can be made in the form of an air-bubble film, with an orderly arrangement of air bubbles, while the film is connected to the bottom of the piston by one side and the support by the other. In this case, the nozzle along the perimeter is equipped with microneedles oriented relative to the air bubbles of the film. The stopper can also be made, as in the first embodiment, in the form of an elastic, hollow ring filled with gas and connected on the one hand to the lower part of the piston, and on the other hand with a support, in this case the nozzle is equipped with microneedles around the perimeter, and on the support through holes are formed that are coaxially oriented to the microneedles. The stopper can be made in the form of processes attached at one end to the bottom of the piston, and the other to the needle support. To prevent spontaneous piercing from below, the elastic shell of the return pusher is made with a thickening. Pointed limiters are made monolithic or hollow. The elastic protective shell covering the syringe body is made transparent and / or opaque or opaque with transparent areas. The base of the body is made with broadening and with the possibility of bending the base, which provides the ability to stretch or collect the skin above the injection site, and is closed with a protective film with a tear-off tab. Between the base of the body and the protective film there is a layer of antiseptic preparation to ensure the necessary treatment of the skin, as well as a layer of substance that facilitates the slip of the base of the syringe relative to the skin during injection and its easy separation after

SUBSTITUTE SHEET (RULE 26) injections. The areas on the base of the body on which these substances are located may be different, or may overlap, for example, an antiseptic preparation may be located in the area of the center of the base, and a substance that facilitates the sliding of the syringe relative to the skin closer to the edge of the base.

An outlet that serves to discharge the gas released by the restrictors from the return pusher into the syringe body to the outside, can be located both in the elastic protective shell and in the base of the housing. When the outlet is located in the elastic protective sheath, this hole is sealed with a protective film, which can be removed manually before the injection and in this case is a part of the tear-off tab of the protective film covering the base of the syringe body and, accordingly, seals the outlet outside the elastic protective sheath, and can also be removed automatically when expanding the return pusher to which it, in this case, is attached and, accordingly, seals the outlet e elastic inside containment. When the outlet is located in the base of the housing, there may be several such openings and they are preferably located closer to the periphery of the base of the housing. Also, the return pusher located above the piston cavity and, respectively, above the drug capsule can be made in the form of an elastic membrane fixed under the convex outward upper part of the protective shell, so that the membrane and the outward convex upper part of the protective shell create a closed volume filled with compressed gas. In this case, the membrane is profiled and is made with a thickening to its center, while due to the adhesive properties of the material

SUBSTITUTE SHEET (RULE 26) membrane, it in contact with the capsule with the medicine and the piston sticks to them. The return pusher can be made in the form of a tape located in the aforementioned closed volume, one end fixed on the surface of the membrane, and the other on the protective shell, while part of the tape fixed on the protective shell seals the outlet, available in this case, on the protective shell. As in the previous version, the base of the body is made with broadening and with the possibility of bending the base, and the protective film is equipped with a tear-off tab, and between the base of the body and the protective film a layer is applied, an antiseptic preparation and a layer of a substance that facilitates the slip of the base of the syringe relative to the skin during injection and its easy separation after injection. The upper part of the support and the hole made in the lower part of the piston are congruent to each other to ensure a tight and backlash-free arrangement of the upper part of the support in the piston when the upper pointed end of the needle passes through the lower piston hole.

According to the invention, the inner side surface of the housing at the base is made with a groove in which the locking assembly is mounted, including a latch with a latch, inside the housing is fixed coaxially to the hole formed in the lower part of the piston and closed by a protective film and the outlet of the fitting located in the center of the base of the body is a double-edged hollow needle on which, in its upper part, a support is rigidly fixed, with a stopper mounted on it,

SUBSTITUTE SHEET (RULE 26) at the same time, a capsule with medicine is fixed in the piston cavity, made in the form of a deformable container, which from the sides and from above covers a return pusher made of spring from an elastic material, the upper part of which is attached to the protective sheath that covers the syringe body.

The implementation of the stopper and fitting is similar to the above options.

The elastic material of the return pusher is made of plastic. The elastic protective shell covering the syringe body is made transparent and / or opaque, and the base of the body is made with broadening and with the possibility of bending the base, and the protective film is equipped with a tear tab. Between the base of the body and the protective film, as well as in other embodiments, a layer of an antiseptic preparation and a layer of substance are applied that facilitate the slip of the base of the syringe relative to the skin during the injection and its easy separation after injection.

Also, the capsule with the medicine can be formed by the piston cavity with a compressible membrane fixed along its perimeter, while the hole made in the lower part of the piston is covered with a protective film. Thus, the drug is in a closed volume limited by the piston cavity, with the lower hole closed by a protective film, and a compressible membrane * fixed around the perimeter of the piston cavity. The stopper is made in the form of an elastic, hollow ring filled with gas and connected on one side to the lower part of the piston, and on the other hand with a support. The perimeter fitting is equipped with microneedles, and through holes are formed on the support

SUBSTITUTE SHEET (RULE 26) holes that are coaxially oriented with microneedles. The stopper can also be made in the form of an air-bubble film, with an ordered arrangement of air bubbles, with the film connected to the bottom of the piston by one side and a support with the other side, while the nozzle is provided with microneedles around the perimeter, and through holes are formed on the support, the number by the number of bubbles of the air-bubble film, which are oriented coaxially to the microneedles, oriented relative to the air bubbles of the film. The stopper can also be made in the form of destructible processes attached at one end to the bottom of the piston, and the other to the needle support. The return pusher located in the piston cavity above the drug capsule is made in the form of an elastic element. The elastic element is made in the form of an elastic shell filled with compressed gas, while the bottom of the shell is made with a thickening to prevent spontaneous piercing. Also, the elastic element can be made in the form of a spring element, which provides the ability to squeeze the capsule with the medicine both from above and, alternatively, from the side surfaces of the capsule with the medicine. The casing is covered with an elastic protective shell,

Another embodiment of a disposable syringe is a syringe containing a housing inside of which a piston with a cavity is placed, a locking assembly and a stopper, according to the invention, the inner side surface of the housing at the base is made with a groove in which the locking assembly is mounted, including a latch with a latch, coaxially mounted inside the housing formed at the bottom of the piston and the nozzle outlet located in the center of the base of the double-edged body

SUBSTITUTE SHEET (RULE 26) a hollow needle, on which, in its upper part, a support is rigidly fixed, with a stopper mounted on it, the variants of which were described above, In the piston cavity there is a capsule with a medicine made in the form of a deformable container, the wall thickness of the container at the place where the needle enters it, preferably should be greater than the height of the bevel of the pointed edge of the needle facing the capsule. Also, the capsule with the medicine can be formed by the piston cavity with a compressible membrane fixed along its perimeter, while the hole made in the lower part of the piston is covered with a protective film. Thus, the drug is in a closed volume limited by the piston cavity, with a protective film closed by the lower hole, and a compressible membrane fixed along the perimeter of the piston cavity. In the upper part of the piston, pointed limiters are fixed, which, depending on the material of which the elastic part of the return pusher is made, can be either hollow or non-hollow; a return pusher made in the form of an elastic shell filled with compressed gas is installed above the medicine capsule attached on top of an elastic protective sheath, which may be either transparent or non-transparent, or opaque with transparent sections covering the syringe body, while the bottom sheath is made and thickening to prevent inadvertent puncturing it.

According to the invention, the inner side surface of the housing at the base is made with a groove in which the locking assembly is mounted, including a latch with

SUBSTITUTE SHEET (RULE 26) with a latch, inside the housing, it is fixed coaxially with the hole formed in the lower part of the piston and the outlet of the fitting located in the center of the base of the body of a double-edged hollow needle on which, in its upper part, a support is rigidly fixed, with a stopper mounted on it, the options for which were described above, it is advisable to perform the upper part of the support and the lower piston hole congruent to each other to ensure a tight and backlash-free location of the upper part of the support in the piston when passing the upper pointed about the end of the needle through the lower bore of the piston. In this case, the capsule with the medicine, made in the form of a deformable container, is fixed on the piston with a cavity, while the hole made in the lower part of the piston is covered with a protective film. The capsule with the medicine from both sides and from above is covered by a return pusher made of an elastic material and in a stressed state, such that its walls press on the capsule with the medicine. In this case, the return pusher is attached from above to the elastic protective sheath, which can be either transparent or not transparent, or opaque with transparent sections covering the syringe body. The elastic material of the return pusher is mainly made of plastic. The base of the body is made with broadening and with the possibility of bending the base, which provides the ability to stretch or collect the skin above the injection site, and is closed with a protective film with a tear-off tab. Between the base of the body and the protective film there is a layer of antiseptic preparation to ensure the necessary treatment of the skin, as well as a layer of substance that facilitates the slip of the base of the syringe relative to the skin during the injection and

SUBSTITUTE SHEET (RULE 26) its lung separation after injection. The areas on the base on which these substances are located may be different, or may overlap, for example, an antiseptic drug may be located in the area of the center of the base, and a substance that facilitates the sliding of the syringe relative to the skin closer to the edge of the base.

A disposable syringe with options for the execution ensures the elimination of the possibility of reuse of the syringe due to destruction or becoming completely unusable during the injection process of the locking and locking elements, as well as the return pusher. The presence of a lock with the piston and needle retainer inside the housing also excludes the possibility of reuse of the syringe, which practically negates the risk of accidental injection with a used needle. The execution of a double-edged needle allows the upper tip to pierce the capsule with the medicine, and the lower pointed end to inject into the patient.

An elastic protective shell, which can be either transparent or not transparent, or opaque with transparent sections, covering the syringe body from above, provides tightness conditions inside the case, and also, if necessary, due to its shape and elastic properties, allows to attach to her return pusher. Also, if necessary, through the transparent sections of the protective shell, you can visually control the visible characteristics of the drug in the capsule with the medicine, such as: color, turbidity, the presence of sediment, it may also be possible to visually control

SUBSTITUTE SHEET (RULE 26) various stages of the injection procedure, while the needle remains hidden from view.

The location of the needle and capsule with the medicine inside the syringe body ensures its sterility. In addition, this design is always ready for use. In this case, the patient can use the syringe independently without the involvement of specially trained medical personnel. The presence of a capsule with a metered amount of the drug simplifies the injection and virtually eliminates the wrong dosage of the drug. Brief Description of the Drawings

The disposable syringe and its variants are illustrated by drawings, where in FIG. L- presents the first embodiment of a disposable syringe in section, prior to the injection; in FIG. 2 - a syringe with a needle inserted to the required depth, at the moment of the beginning of entry of the upper end of the needle into the capsule with the medicine; in FIG. 3 - the second embodiment of the syringe, before the injection; in FIG. 4 - phase of drug administration; in FIG. 5 - the final phase of drug administration, shortly before the interaction of the elastic membrane with the limiters; in FIG. 6 - removing the needle through the spring element; in FIG. 7 - removing the needle by means of a return pusher; in FIG. 8 is a third embodiment of a disposable syringe prior to injection; in FIG. 9 is a part of a syringe showing a drug capsule formed by a piston cavity with a compressible membrane fixed to its perimeter and an opening with a closed protective film; in FIG. 10 - presents the upper part of the syringe in which the return pusher is made in the form of an elastic membrane fixed under the convex outward upper part of the protective shell;

SUBSTITUTE SHEET (RULE 26) Detailed Description of Drawings

The disposable syringe contains a housing 1 inside of which a piston 2 with a cavity 3, a locking assembly 4 and a stopper 5 are placed. The inner side surface of the housing 1 at the base is made with a groove in which the locking assembly 4 is mounted, including a latch 6 with a latch 7. Coaxially fixed inside the housing 1 hole 8, formed in the lower part 9 of the piston 2 and the outlet of the fitting 10, located in the center of the base 11 of the housing 1, a double-edged hollow needle 12. On the needle 12, in its upper part, a support 13 is rigidly fixed, with a a support 14. Between the base 11 of the housing 1 and the piston 2 a spring element 15 is installed 15. In the cavity 3 of the piston 2 there is a capsule 16 with medicine, over which a return pusher 17 is located. The stop 5 is made in the form of an elastic, hollow ring 18 filled with gas and connected to on the one hand, with the lower part 9 of the piston 2, and on the other, with the support 13. The fitting 10 is provided with microneedles 19 around the perimeter, and through holes 20 are formed on the support 13, which are coaxially oriented to the microneedles 19. The stopper can also be made in the form of an air bubble films (in Fig. not shown), with an ordered arrangement of air bubbles. In this case, the film is connected on one side to the lower part 9 of the piston 2 and on the other to the support 13, while the nozzle along the perimeter is equipped with microneedles 19, and through holes 20 are formed on the support, equal in number to the number of bubbles of the air bubble film. The stop 5 can also be made in the form of destructible processes 21 attached at one end to the lower part 9 of the piston 2, and the other to the support of the needle 13. The base 11 of the housing 1 is made with broadening and with the possibility of bending, for

SUBSTITUTE SHEET (RULE 26) allowing stretching or collecting skin above the injection site. The base 11 is covered with a protective film 22 with a tear tab 23. Between the base 11 of the housing 1 and the protective film 22 there is a layer of antiseptic drug 24, as well as a layer of substance 25, which facilitates the non-slip of the base 11 of the syringe relative to the skin during the injection and its easy separation after the injection . The housing 1 is covered on top with an elastic protective sheath 26, which can be either transparent or non-transparent, or opaque with transparent sections. In FIG. 9 shows the part of the syringe in which the capsule 16 with the medicine is formed by a bowl-shaped cavity 3 of the piston 2 with a compressible membrane 27 fixed along its perimeter, while the hole 8 is closed by a protective film 28.

The next embodiment of the disposable syringe (Fig. 3) is a syringe containing a housing 1 inside which a piston 2 with a cavity 3, a locking assembly 4 and a stopper 5 are placed. The inner side surface of the housing 1 at the base is made with a groove in which the locking assembly 4 is mounted, including a latch 6 with a latch 7, inside the housing 1 is fixed coaxially to the hole 8 formed in the lower part 9 of the piston 2 and the outlet of the fitting 10 located in the center of the base 11 of the housing 1, a double-edged hollow needle 12, on which, in its upper parts, the support 13 is rigidly fixed, with the stopper 14 mounted on it, the variants of which were described above. In the cavity 3 of the piston 2, a capsule with medicine 16 is fixed. In the upper part 29 of the piston 2, pointed stoppers 30 are fixed, a return pusher 17 is installed above the capsule 16, made in the form of an elastic shell 31 filled with compressed gas,

SUBSTITUTE SHEET (RULE 26) attached on top of the elastic protective sheath 26, which can be either transparent or non-transparent, or opaque with transparent sections covering the syringe body 1, while the elastic sheath 31 is made from the bottom with a thickening 43 to prevent spontaneous piercing. An exhaust port 32 for discharging the gas discharged by the restrictors 30 from the return pusher 17 from the syringe body 1 to the outside. The outlet 32 can be located both in the elastic protective sheath 26 and in the base 11 of the housing 1. When the outlet 32 is located in the base 11 of the housing 1, there may be several such openings and they are preferably located closer to the periphery of the base 11 of the housing 1 and sealed with a protective film 22. When the outlet 32 is located in the elastic protective sheath 26, this hole is sealed with a protective film 33. The base 11 of the housing 1 is made as described above. In FIG. 10 shows the upper part of the syringe, in which the return pusher 17 is located above the cavity 3 of the piston 2 and, respectively, above the drug capsule 16 is made in the form of an elastic membrane 34 fixed under the convex outward upper part 35 of the protective sheath 26, while the membrane 34 is profiled and made with a thickening to its center. In this embodiment, the return pusher 17, along with the above-described stoppers 30, another variant of the stopper can be used, namely the tape 36, one end fixed to the surface of the membrane 34, and the other end to the protective sheath 26, while part of the tape fixed to the protective sheath 26 seals the outlet 32, located in this case, on the protective sheath 26.

SUBSTITUTE SHEET (RULE 26) The next embodiment of the disposable syringe (Fig. 8) is a syringe in which the capsule 16 with the medicine is fixed in the cavity 3 of the piston 2, while the hole 8 is closed with a protective film 28. The capsule 16 with the medicine covers the pusher 17 on the sides and top, made from an elastic material, mainly plastic, and is in a stressed state, while its walls 37 are pressed against the capsule 16 with the medicine. The return pusher 17 with its upper part is attached to the outwardly convex upper part 35 of the protective sheath 26 covering the syringe body, which may be either transparent or non-transparent, or opaque with transparent sections. The base 11 of the housing 1 is made as described above.

Disposable syringe and its options works as follows. From the base 11 of the housing 1, the protective film 22 is removed by pulling on the tear tab 23. Apply the syringe with the base 11 to the place where the injection should be made, stretching or collecting skin over the injection site if necessary. From above, the fingers press the upper part 35 of the elastic protective sheath 26. In this case, the pressure of the finger is transmitted to the return pusher 17 and then to the capsule 16 with the medicine and piston 2. At the same time, the piston 2 begins to move downward, compressing the spring element 15. Piston 2 moving down, breaks the latch 7, which is fixed on the latch 6, which is accompanied by an audio-tactile signal and moves further down. The lower end of the cannula 12 passes through the outlet of the fitting 10 and penetrates under the skin or muscles of the patient. With further advancement of the piston 2, microneedles 19 penetrate through holes 20 in the support

SUBSTITUTE SHEET (RULE 26) 13. Microneedles 19 piercing ring 18 or bubbles of an air bubble film release air that is within the ring 18 or bubbles of an air bubble film. Accordingly, the ring 18 or the air-bubble film lose their elasticity and do not retain the needle 12 from penetrating inside the piston 2. Under further pressure on the upper part 35 of the elastic protective sheath 26, the fitting 10 presses on the support 13 of the needle 12, the upper end of the hollow needle 12, in turn, passes through the bore 8 of the piston 2 and pierces the capsule 16 with the medicine. After the capsule 16 is pierced, the return pusher 17 begins to expand, pressing against the walls of the capsule 16 with the medicine, and pushes the medicine through the needle 12 into the patient. After all the medicine has been released through the hollow needle 12, the pressure of the finger is removed from the upper part 35 of the elastic protective sheath 26. The needle 12 due to the fact that the spring element 15 pushes the piston 2 upward, respectively, also rises upwards, into the housing 1. The latches 6 come out of the groove and abut against the lower part 9 of the piston 2, preventing it from dropping down again, thus reliably locking the piston 2 and the needle 12 inside the housing 1, providing only a one-time use of the syringe and, practically eliminating the risk of accidentally pricking the needle after the injection. When the stopper 5 is made in the form of destructible processes 21 attached at one end to the lower part 9 of the piston 2 and the other to the needle support 13, they, when the nozzle 10 is pressed against the support 13, are destroyed and allow the upper pointed end of the hollow needle 12 to pass through the piston hole 8 2, piercing capsule 16 with the medicine.

SUBSTITUTE SHEET (RULE 26) The next embodiment of the operation of the syringe is also carried out by removing the protective film 22, pulling the tear tab 23. Next, apply the syringe base 11 to the place where the injection should be made, if necessary stretching or collecting skin over the injection site. From above, the fingers press on the upper part 35 of the elastic protective sheath 26. In this case, the pressure of the finger is transmitted to the return pusher 17 and then to the capsule 16 with the medicine and the piston 2, which, moving down, breaks the latch 7, mounted on the latch 6, which is accompanied by tactile audio signal. After that, the pressure of the finger on the upper part 35 of the elastic protective sheath 26 is removed. Next, the piston 2 moves further down under the action of a swelling return pusher 17. The lower end of the hollow needle 12 passes through the opening of the nozzle 10 and penetrates the patient. With further advancement of the piston 2, microneedles 19 penetrate through holes 20 in the support 13, which pierce the ring 18 or bubbles of the air bubble film. The air inside the ring 18 or bubbles of the air bubble film provides the elasticity of the ring 18 or air bubble film, allowing them to keep the hollow needle 12 from penetrating into the piston 2 inoperative. After the puncture, the ring 18 or the air bubble film 18a lose their elasticity and do not retain the needle 12 from penetrating the piston 2. Under the continuing action of the inflated return pusher 17, the fitting 10 presses the support 13 of the needle 12, the upper end of the hollow needle 12, into in turn, passes through the hole 8 of the piston 2 and punctures the capsule 16 with the medicine. After will

SUBSTITUTE SHEET (RULE 26) punctured the capsule with the drug 16, the return pusher 17, while continuing to swell, presses on the walls of the capsule and pushes the drug through the needle 12 into the patient. The thickening 44 prevents the needle 10 from piercing the return pusher 17 with the needle 12. After all the medicine has been released through the hollow needle 12, the return pusher 17 continues to inflate against the stops 30, puncture and get stuck in it, causing it to compress and take its original shape due to its elasticity. The compressed gas, which was previously inside the return pusher 17 and caused it to swell, exits. out through the outlet 32.

When using the return pusher 17 in the form of an elastic membrane 34, after all the medicine has been released through the hollow needle 12, the elastic membrane 34 continues to inflate and tears off the end of the tape 36 secured to the protective sheath 26 and seals the outlet 32, thereby releasing compressed gas out. In this case, the return pusher 17 is compressed and assumes its original shape due to its elasticity and due to the adhesive properties of the membrane material, it adheres to them upon contact with the capsule 16 and the piston 2. The needle 12 due to the fact that the return pusher 17 pulls the piston 2 upward, respectively, also rises upward into the housing 1. The latches 6 come out of the groove and abut against the lower part 9 of the piston 2, preventing it from lowering down again, thus reliably locking the piston 2 and the needle 12 inside the housing 1, providing only a single use of the syringe and virtually eliminating the risk of accidental injection by the needle after the injection.

SUBSTITUTE SHEET (RULE 26) When the disposable syringe of the other option is operated, after the capsule 16 has been punctured, the return pusher 17 begins, trying to come into a relaxed state, closes, pressing on the walls of the capsule 16 with the drug, thereby pushing the medicine through the needle 12 into the patient. After all the medicine is released through the hollow needle 12, which can be visually checked through the transparent portions of the protective sheath, finger pressure is removed from the upper part 35 of the elastic protective sheath 26. In this case, the elastic protective sheath 26 under the action of elastic forces takes its original shape . In this case, the needle 12 rises upward inside the housing 1, due to the fact that the return pusher 17, being fixed on the elastic sheath 26, follows its upward movement, entraining the capsule 16, which remains compressed by the walls 37 of the return pusher 17. The latches 6 exit from the groove and abut against the lower part 9 of the piston 2, preventing it from repeatedly lowering down, thus reliably locking the piston 2 and the needle 12 inside the housing 1, providing only a single use of the syringe and practically eliminating the risk of accidentally pricking the needle after holding injections. A disposable syringe may be made of materials known to those skilled in the art. For example, a capsule with a medicine can be made in the form of a deformable container, can be made of single or multi-layer low density polyethylene with low permeability to water vapor, and can be made, for example, by heat sealing by vacuum or pneumoforming. If necessary, contain the medicine in a glass container, the capsule with the medicine can be formed by the piston cavity, for example, can be made of medical glass, with

SUBSTITUTE SHEET (RULE 26) a compressible membrane fixed around its perimeter, while the hole made in the lower part of the piston must be covered with a protective film. Similarly, the return pusher, made in the form of an elastic shell, can be made from a sterilized elastomer, such as, for example, silicone rubber. Similarly, the outer protective shell can be made of polyethylene terephthalate (PET), for example, by thermo-, vacuum-, and pneumoforming methods. The above examples do not limit the possibility of its use in other embodiments within the scope of the claims.

SUBSTITUTE SHEET (RULE 26)

Claims

Claim

1. A disposable syringe containing a housing inside of which a piston with a cavity, a locking assembly and a stopper are arranged, characterized in that the inner side surface of the housing at the base is made with a groove in which the locking assembly is mounted, including a latch with a latch, coaxially fixed to the hole formed inside the housing in the lower part of the piston and the outlet of the fitting located in the center of the base of the body is a double-edged hollow needle on which, in its upper part, a support is rigidly fixed, with it mounted on with a stopper, a spring element is installed between the base of the housing and the piston, while in the piston cavity there is a capsule with medicine, over which a return pusher is installed, the housing is covered with an elastic protective shell on top, and its base with a protective film.

2. The disposable syringe according to claim 1, characterized in that the capsule with the medicine is made in the form of a deformable container.

3. The disposable syringe according to claim 1, characterized in that the stopper is made in the form of an elastic, hollow ring filled with gas and connected to the lower part of the piston on one side and to the support on the other.

4. The disposable syringe according to claim 1, characterized in that the nozzle along the perimeter is equipped with microneedles, and through holes are formed on the support, which are aligned with the microneedles.

5. The disposable syringe according to claim 1, characterized in that the stopper is made in the form of processes attached to one end to the bottom of the piston and the other to the needle support.

SUBSTITUTE SHEET (RULE 26)

6. The disposable syringe according to claim 1, characterized in that the return pusher is made in the form of an elastic element formed by an elastic shell filled with compressed gas, while the bottom of the shell is made with a thickening.

7. The disposable syringe according to claim 1, characterized in that a layer of an antiseptic preparation is applied between the base of the body and the protective film.

8. A disposable syringe containing a housing inside of which a piston with a cavity, a locking assembly and a stopper are arranged, characterized in that the inner side surface of the housing at the base is made with a groove in which the locking assembly is mounted, including a latch with a latch, coaxially fixed to the hole formed inside the housing in the lower part of the piston, covered with a protective film and the outlet of the fitting located in the center of the base of the body, a double-edged hollow needle, on which, in its upper part, is rigidly fixed a support with a stopper mounted on it, while the piston cavity is bowl-shaped, filled with medicine and covered by a compressible membrane fixed along the perimeter of the piston cavity onto which the return pusher is mounted, in the form of an elastic element formed by an elastic shell filled with compressed gas and attached peaked limiters are fixed in the upper part of the piston to pierce the return pusher, and in the protective shell and / or to the base In the case of the casing, a gas outlet was made, while the base of the casing was covered with a protective film.

SUBSTITUTE SHEET (RULE 26)

9. The disposable syringe according to claim 8, characterized in that the stopper is made in the form of an air-bubble film, with an orderly arrangement of air bubbles, while the film is connected to the bottom of the piston by one side and the support with the other.

10. The disposable syringe according to claim 8 and 9, characterized in that the nozzle along the perimeter is equipped with microneedles oriented relative to the air bubbles of the film.

11. The disposable syringe according to claim 8, characterized in that the stopper is made in the form of an elastic, hollow ring filled with gas and connected on one side to the lower part of the piston and on the other hand with a support.

12. The disposable syringe according to claim 8, characterized in that the nozzle along the perimeter is provided with microneedles, and through holes are formed on the support, which are coaxially oriented to the microneedles.

13. The disposable syringe according to claim 8, characterized in that the stopper is made in the form of processes attached at one end to the lower part of the piston and the other to the needle support.

14. The disposable syringe according to claim 8, characterized in that the bottom of the elastic shell of the return pusher is made with a thickening.

15. The disposable syringe according to claim 8, characterized in that the pointed stoppers are made monolithic or hollow.

16. The disposable syringe according to claim 8, characterized in that the elastic protective sheath covering the syringe body is made transparent and / or opaque.

17. The disposable syringe according to claim 8, characterized in that when the gas outlet is located in an elastic protective sheath, this hole is sealed with a protective film.

SUBSTITUTE SHEET (RULE 26)

18. The disposable syringe according to claim 8, characterized in that the gas outlets are located on the periphery of the base of the housing.

19. The disposable syringe according to claim 8, characterized in that the return pusher is made in the form of an elastic membrane fixed under the convex upper part of the protective shell, creating a closed volume filled with compressed gas, while the membrane is shaped and thickened to a center with adhesive properties in contact with the capsule with the medicine and the piston - sticks to them.

20. The disposable syringe according to p. 8 and 19, characterized in that the stopper is made in the form of a tape fixed in a closed volume, one end on the surface of the membrane, and the other on the protective shell of the syringe body, while part of the tape fixed on the protective shell seals the outlet hole.

21. The disposable syringe according to claim 8, characterized in that the base of the body is made with broadening and with the possibility of bending the base, and the protective film is equipped with a tear-off tab.

22. The disposable syringe according to claim 8, characterized in that a layer of an antiseptic preparation and a layer of substance are applied between the base of the body and the protective film, which facilitates the slip of the base of the syringe relative to the skin during the injection and its easy separation after injection.

23. The disposable syringe according to claim 8, characterized in that the upper part of the support and the hole made in the lower part of the piston are congruent.

SUBSTITUTE SHEET (RULE 26)

24. A disposable syringe containing a housing inside of which a piston with a cavity, a locking assembly and a stopper are arranged, characterized in that the inner side surface of the housing at the base is made with a groove in which the locking assembly is mounted, including a latch with a latch, coaxially fixed to the hole formed inside the housing in the lower part of the piston and closed by a protective film and the outlet of the fitting located in the center of the base of the housing a double-edged hollow needle, on which, in its upper part, is rigidly fixed and the support, with a stopper mounted on it, while in the piston cavity there is a capsule with medicine made in the form of a deformable container, which from the sides and from above covers a return pusher made of spring from an elastic material, the upper part of which is attached to the protective shell covering the syringe body .

25. The disposable syringe according to claim 24, characterized in that the stopper is made in the form of an elastic, hollow ring filled with gas and connected on one side to the lower part of the piston and on the other hand with a support.

26. The disposable syringe according to claim 24, characterized in that the nozzle along the perimeter is equipped with microneedles, and through holes are formed on the support, which are coaxially oriented to the microneedles.

27. The disposable syringe according to claim 24, characterized in that the stopper is made in the form of processes attached to one end to the bottom of the piston and the other to the needle support.

28. The disposable syringe according to claim 24, characterized in that the upper part of the support and the hole made in the lower part of the piston are congruent.

SUBSTITUTE SHEET (RULE 26)

29. The disposable syringe according to claim 24, characterized in that the elastic material of the return pusher is made of plastic.

30. The disposable syringe according to claim 24, characterized in that the elastic protective shell covering the syringe body is made transparent and / or opaque.

31. The disposable syringe according to claim 24, characterized in that the base of the body is made with broadening and with the possibility of bending the base, and the protective film is equipped with a tear-off tab.

32. Disposable syringe according to l. 24, characterized in that between the base of the housing and the protective film a layer of antiseptic preparation and a layer of substance are applied that facilitate non-slip of the base of the syringe relative to the skin during the injection and its easy separation after injection.

SUBSTITUTE SHEET (RULE 26)