Normal;heading 1;heading 2;heading 3;AUTO-INJECTOR AND METHOD OF PRIMING THE DEVICE

Ukraine ₍₁₉₎ Id (her) 100745 (s) C2

(51) IPC

A61M 5/178 (2006.01)

A61M 5/20 (2006.01)

STATE SERVICE INTELLECTUAL OPPORTUNITY OF UKRAINE

(12) DESCRIPTION TO A patent for an invention

(21) Application number: a 2011 00574

(22) Date of application: 10.06.2009

(24) Date from which the law of 25.01.2013 is in force:

(31) The number of the previous 0811345.8 application in accordance with the Paris Convention:

(32) Date of submission 19.06.2008

previous application

in accordance with the Paris Convention:

(33) Code of the State Party to the CBC,

to which a previous application has been filed:

(41) Publication of information 10.05.2011, Bulletin No. 9 on application:

(46) Publication of information dated 25.01.2013, Bulletin No. 2 on the issuance of a patent:

(86) Number and date of PCT / CB2009 / 001453,

international representation _{June 10, 2009}application filed

in accordance with the PCT Agreement

(72) The inventor (s):

Jennings Douglas Ivan (OV),

Burnell Rozmerie Louise (OV)

(73) Owner (s):

CILAG GMBH INTERNATIONAL,

IAPSII5 + SugZIGasee 1, CH-6300 2nd, ZadinEgyIpsi (CH)

(74) Representative:

Moshynska Nina Nikolaevna, registry number 115

(56) List of documents taken into account by examination:

IZ 2003/036725, 02.02.2003OTO 00/06227, 10.02.2000 and 6162199, 19.12.2000 of 2003/105430, 05.06.2003of 2003/088216, 08.05.2003RR 2654938, 31.05.1991

(54) AUTOMATIC INJECTOR AND METHOD OF ACCEPTING IT IN READINESS

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(57) Summary:

The first claimed object of the invention is an automatic injection device having a first sub-node (110), wherein the first sub-node (110) comprises: a housing (111); the camera (112), which is located inside the body (111) and has a proximal and distal ends, an inner surface and an outlet (114); and a cork (113) which is movably located inside the chamber (112) and has an outer surface substantially in contact with said inner surface on its perimeter; socket (118) ruhomevidnosno body (111) and connected to the chamber (112) so that movement of the seat (118) vyklykayevidpovidne displacement chamber (112) and outlet (114) relative to the housing (111), with This nest is made of the ability to receive a container (119), which contains the flow of the medium. When the jack (118) and the camera (112) are moved relative to the housing (111), the stopper (113) remains stationary relative to the housing, so that the displacement of the jack (118) causes the displacement of the outlet (114) relative to the stopper (113). The second claimed object of the invention is a method for preparing an automatic injector having a first subwoofer (110) comprising a housing (111). The method includes the steps of: inserting the container (119) into the socket (118) on the injector, with the socket (118) being movable relative to the housing (111), and the first subwoofer

(112) has a chamber (112) having an outlet (114) and a cork (113) movably located inside the chamber (112), where the chamber (112) is connected to the nest (118) so that the movement of the nest (118) causing the corresponding movement of the chamber (112) and the outlet (114) relative to the housing

(111), while the jack (118) and the camera (112) are moved relative to the body (111), the stopper (113) remains stationary relative to the housing (111) so that the movement of the jack (118)

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causes movement of the outlet (114) relative to the stopper (113); moving the jaw (118) into the body (111); and moving the nest (118) from the housing (111) in such a way that fluid flows into the chamber (112) from the container (119).

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The present invention relates to an injection device, in particular an auto-injector for multiple use, in which the patient can be transferred from the vial to pre-injectable injection. The use of automatic injection devices (commonly referred to as automatic injectors) for delivering medicines to the patient provides many advantages with printed syringes. In particular, automatic injectors help to reduce the burden on the staff of the hospital to deliver the drug to the patient as a result of the fact that the patients independently able to safely and safely use devices at home.

Known auto-injectors are described in ıδ 2003/0105430, SHO 95/35126 and EP-A-0 516 473. Similarly, danit-like automatic injectors usually provide ready-made devices (i.e., with a pre-tensioned spring) and ready for use to perform other ' For these reasons, it is difficult to administer the drug into an auto-injector, and as a result, manufacturers of such automatic injectables usually use a pre-filled syringe that is pre-used in an auto-injector or a complete unit with an automatic injector. apovnyuyut specific drug.

This requires a more complex and costly production process than could otherwise be necessary for an automatic injector, as a result of the fact that manufacturers must also receive and provide medicinal products and maintain equipment for their storage and processing. In addition, manufacturers should enter in There are separate production lines for each drug that is needed.

Medicines for medical use are often produced and distributed in standardflavons. Thus, medicines can be supplied in large batches conveniently and relatively cheaply, regardless of the way in which the drug is, as a result, used.

Considerable cost savings can be obtained by providing an automatic injection device that can pull a drug from a standard bottle, instead of counting on a pre-filled syringe. Such a device should be beneficial not only to manufacturers who no longer have to make custom-made devices with full medical devices, but also to hospitals who should like the simplified injection system of the invention and who can use standard steel vials that are used on a regular basis and patients who can Be provided with supply of fluocones for self-administration.

In addition, the use of bottles provides the opportunity to reuse a larger part of the automatic injection device. As a rule, automatic injectors are provided in the form of two bases. The first sub-module contains working devices and all other elements that are reused, and the second sub-assembly contains components for spraying, which should be replaced each time when using the device.

The main factor in the cost of the second sub-node is the provision of a camera that is pre-filled with a medicinal product to be injected. As explained above, providing a series of syringes is an expensive and time-consuming aspect of the process of manufacturing an autoinjector. The use of standard vials should allow reducing costs.

Standard vials can be used for reconditioning and injection devices, as disclosed in ıδ 2003/0036725. In one embodiment, disclosed in a given document, the vial is inserted into a slot-shaped slot on the body of the device where it is attached to the needle. The syringe may also be engageable with the housing for connection to the flowing medium through the rotating stem. The fluid can thus be drawn from the vial into the syringe when the syringe is in the first position.

The loading mechanism for a non-medicated medical injector is disclosed in SCHO00 / 06227. The injector of this document contains a nozzle knot, which can be hooked with a standard bottle. A movable plunger in the fluid chamber can be manipulated through a spring, a driving sleeve for the dose to drag the fluid in the chamber from the vial before the device is actuated.

ıδ 6162199 uncovers a manual device for loading a standard syringe for subcutaneous injections from a standard vial. The device contains in-depth areas for the insertion of each component and bringing them into interaction with each other, and the tongue, which is used to pull the piston of the syringe to extract the contents of the vial.

The object of the present invention is to solve the above-mentioned problems. Accordingly, the automatic injector has a node, where the first sub-module contains a body; The camera is located inside the body, with the camera has a proximal and distal ends, the inner surface and outlet; a cork, which is movably located inside the chamber and has an outer surface in hand in contact with the inner surface on its perimeter; and a slider movable relative to the housing and connected to the camera so that the movement of the slot causes the camera to move properly and

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the outlet, relative to the housing, with the slot executed with the ability to take a container containing the fluid; In this case, when the slot and camera are moved relative to the housing, the stopper remains stationary relative to the housing, so that the displacement of the slot causes the outlet to move relative to the stopper.

Providing an automatic injector having a camera in which the fluid may be transferred from a single container provides at least two advantages over the previous level of technology. First, manufacturers of an automatic injection device no longer need to produce a series of pre-filled syringes for introduction into the sub-unit, which is used repeatedly. Instead, the manufacturer may provide a single type subunit according to the present invention, in which any kind of medicinal product may be transferred immediately before injection. The sub-node of a single type can be produced in large batches, with a decrease through this production cost.

This advantage leads to a second advantage, according to which the invention can be used in conjunction with any type of container from which the drug can be transferred to the chamber. In particular, the invention can be used with standard vials.

In addition, the invention provides a great opportunity to reuse the needle assembly. While known automatic injection systems require pre-filled syringes, the possibility of transferring fluid to the camera inside the device with a needle has a large frame for reuse.

The volume of the chamber in which the fluid is transferred is determined by the space between the stopper and the outlet. Consequently, the volume decreases as the cork moves in the direction of the outlet and increases as the cork moves from the outlet. Increasing the volume causes the initial pressure drop in the chamber, which, by doing so, draws the environment into the chamber.

The slot may be configured to allow the container to engage with an outlet with a fluid transfer capability, when the outlet is arranged next to the plug. In this situation, the volume of the camera is the smallest or essentially the smallest. Perhaps, the engagement between the container and the outlet forms a channel for the fluid environment in order to transfer the fluid from the container to the camera. According to this embodiment, as the volume of the camera increases (for example, due to the displacement of the outlet from the plug), the fluid is transferred from the container to the camera.

In some embodiments, the displacement element is connected to the socket and is performed with the displacement of the socket in such a way that the outlet is pushed away from the plug. Starting from the position mentioned above (i.e. when the outlet is located adjacent to the nozzle and the container is in contact with the outlet from the possibility of transferring the fluid), the effect of the displacement element will cause the transfercurrent to the chamber without the need for external influence. Optionally, the shifter element is a spring, but also provides other elements that perform a similar function.

In other embodiments, the injection device comprises an outlet nozzle in conjunction with a fluid outlet outlet. Of course, containers that are suitable for use with the device include a lid made, for example, from rubber or foil. In such cases, the output nozzle can be executed with the ability to pierce the lid to form a channel for the fluid to move the fluid from the container to the camera.

Further, the invention will be described by way of example with reference to the attached drawings in which:

FIG. 1 is a side view of the first substrate of the injection device;

FIG. 2 is a side view of the first substrate in which the lid was removed;

FIG. C is a side view of a container that binds to the first substrate;

FIG. 4 is a view from the side of the first substrate in a fully retracted position;

FIG. 5 is a view from the side of the first subassembly in the fully extended position;

FIG. 6 is a view from the side of a container taken from the first subassembly;

FIG. 7 is a side view of a first subassembly coupled to a second subassembly; and

FIG. 8 is a view from the side of an injection device, consisting of the first and second subdivisions.

FIG. 1-4 illustrate a first software sub-module suitable for use in an auto-injector according to the present invention.

The first sub-assembly 110 includes a housing 111 and a chamber 112 located inside the housing. The housing 111 has a proximal 111a and a distal 111b end. Camera 112 has a proximal and

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distal ends corresponding to the proximal and distal ends of the body, and internal surface. A stopper 113. A protuberance 112 is movably located inside the chamber 112 and has an outer surface, along with a proximal end of the chamber. The outer surface of the plunger 113 is substantially in contact with the interior surface of the chamber 112 along its perimeter.

An outlet 114 is provided at the distal end of the chamber 112. An injection needle 115 is provided in conjunction with a fluid medium with an outlet 114. An injection needle 115 is designed to pierce the patient's skin and deliver the drug subcutaneously. The pulp 115 is also intended for piercing a foil or rubber cap , which can be provided on the bottle.

The first subwoofer 110 includes a removable cover 116 including a protective cap 117 disposed above the needle 115. The protective cap 116 protects the needle and provides essentially a leaky seal for the fluid above the tip of the needle to prevent unwanted penetration or fluid overflow.

FIG. 2 illustrates a first subwoofer according to FIG. 1, while the lid 116 was removed from the first sub-assembly 110. When the lid 116 was removed from the needle 115, a protective cap 116 was removed. As you can see in this figure, the first subwove contains a socket 118 (or sleeve). In this configuration, the nest 118 surrounds the needle to prevent damage to the needle or accidental contact between the needle and the user.

The slot 118 is movable relative to the housing 111 but is connected to the camera 112 in such a way that the movement of the slot 118 causes the camera 112 and the outlet 114 to move accordingly to the housing 111. In FIG. 2 socket 118 and, consequently, the camera 112 are in a fully raised position.

The sub-node 110 comprises a displacement member 121 that acts on the nest 118, pushing it off the housing 111. Thus, the displacement member 121 displaces the outlet 114 of the chamber 112, which is mobile in relation to the housing 111, from the plug 113 which, at this moment of operation of the automatic injector ( that is, before the operation of an automatic injector, specifically before pushing a node with a needle from the body), is fixed relative to the body. As shown in FIG. 2, the plug 113 is connected to the support rod 124 through the support unit 126. The support rod is attached to the housing 111. The stopper 113 hinges in the support unit 126 and remains stationary relative to the supporting rod 124 when the socket 118 and the camera 112 are propagated in the direction of the proximal end 111a of the housing (described in detail lower). The chamber is made with the ability to slip from the top support rod 124 and the support unit 126.

At its distal end 111b, the housing 111 comprises a first latch 122a. The second latch122b provided on the nest 118 is docked with the first strap 122a, when the nest 118 and chamber112 are in a fully raised position. The latches 122 prevent the slot 118 from being moved beyond the position under the action of the displacement element 121.

As shown in FIG. C, socket 118 is made with the ability to receive a container 119 containing a fluid medium, for example, a pharmaceutical product. FIG. Since depicts a bottle, but other containers may be used. The container 119 at one end includes a cover 120 completely. As illustrated, the end of the container having the lid 120 is inserted into the inlet 118 while the jack is in the raised position. The size and shape of the slot 118 are selected so as to receive the container 119 and to hold it inside the slot 118 without the need for any additional fixing device. Of course, the fixative may be provided to provide a better mount.

The useful volume of the camera 112 in which the fluid may be transferred depends on the distance between the stopper 113 and the outlet 114. In FIG. 1-3 useful volume of the camera 112 is the highest in the world. However, in this state, before inserting the container 119, the camera 112 is empty. The process for transferring the fluid from container 119 to the camera 112 will be described with reference to FIGS. 4 and 5

When the user inserts the container 119 into the socket 118, the container is held inward by a flange (not shown) provided around the inner surface of the jaw 118. The flange occupies a hole in the container 119, thereby fixing with this container inside the socket 118.

As the container 119 moves forward, pushing the jaw 118 and the camera112 in the direction of the proximal end 111a of the body 111 is pushed forward. As the camera 112 moves in the direction of the proximal end 111a of the housing, the outlet 114 moves to the direction of the stopper 113. The useful volume of the camera 112 accordingly decreases.

FIG. 4 shows the first subwoofer 110 when the socket 118 and the camera 112 are in a fully retracted position. As illustrated, the plug 113 is completely retracted

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is located directly next to the outlet 114. In this configuration, the usefulness of the camera 112 is essentially the smallest.

As the user engages the container 119 with the socket 118, the injection head 115 pierces the lid 120 and provides a fluid channel between the container 119 and the camera 112. The fluid channel starts in the container 119, passes through the injection needle 115, and outlet 114 and ends in chamber 112.

In FIG. 4, the fluid is enclosed within the container 119. As the user releases the container 119, the displacement member 121 pushes the socket 118 out of the body 111 and, accordingly, pushes the outlet 114 from the plug 113. The container 119 remains fixed in the jaw 118 and engaging with the needle 115, which moves together with the outlet 114. Thus, the fluid channel is stored.

As the exhaust port 114 moves away from the plug 113, the useful volume of the camera 112 increases. Increasing the volume of the camera 112 causes a decrease in the pressure in the chamber, and the difference between the vial and the camera causes the fluid to draw from the container 119 through the fluid channel to the chamber 112. The further the outlet 114 moves away from the plug 113, the more fluid the medium is drawn into the chamber 112

FIG. 5 illustrates the sub-assembly 110 after the displacement member 121 pushed the socket 118 and the chamber 112 into a completely raised position. As before, the latches 122a, b on the housing 111 and the nests 118 prevent excessive pushing 118. As shown, the fluid was completely transferred from container 119 to the camera 112. The useful volume of the camera 112 between the plug 113 and the outlet 114 is now filled with a fluid medium.

After waste, the empty container 119 may be removed from the first subassembly 110 and discarded. FIG. 6 illustrates the first sub-node 110, which was ready (that is, filled with fluid) and ready for use.

To enter the fluid, the first subwoofer 110 is introduced into the engagement with the second housing 210. As illustrated in FIG. 7, the second sub-module comprises a housing 211 and an actuating mechanism 212. The housing has a proximal end 211a and a distal 211b and a cover 213 located at the proximal end 211b. The cover includes painted 215, which may be engraved with the housing 111 of the first sub-assembly 110. In the second sub-node 210, a slit-hole 214 is provided.

After the first subwoofer 110 is ready, the distal end 211b of the housing 211 of the second subassembly 210 is inserted into the proximal end 111a of the body 111 of the first subzone 110. The chamber 112 is inserted inside the slit opening 214 and connected to the driving mechanism 212. The second subwoofer 210 is fastened to the first the substrate 110 by means of the rotation of the lid 213, which engages the engagement, painted 215 with the body 111 of the first subwoel110.

FIG. 8 illustrates an injection device 300 that was ready and ready for use. The actuation of the impact mechanism of the injection device 300 results in a drive mechanism 212 that outputs the needle 115 beyond the injection device 300 by shaving the patient's skin and carries a stopper 113 through the chamber 112 injecting the fluid to the patient. The drive mechanism 212 then drives the needle 115 so that it is fully inside the injection device 300.

After the fluids have been injected, the second sub-assembly 210 may be dismounted from the first sub-assembly 110 and reused. The first sub-node 110 may be thrown out with the provision of a new first sub-node for subsequent injections, or may be sterilized for reuse.

It is important to take into account that in the described embodiment, changes may be made without exceeding the scope of the claims.

FORMULA INSTRUCTIONS

An automatic injector having a first subwoofer (110), wherein the first subwove (110) comprises: a housing (111);

a camera (112) that is located inside the body (111) and has a proximal and distal ends, an inner surface and an outlet (114); and

a cork (113) which is movably located inside the chamber (112) and has an outer surface substantially in contact with said inner surface along its perimeter;

the jack (118) movable relative to the housing (111) and is connected to the camera (112) so that the displacement of the nozzle (118) causes the corresponding movement of the camera (112) and the outlet (114) relative to

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the case (111), with the slot made with the ability to receive a container (119), which containscontent of fluid;

while the socket (118) and the chamber (112) are moved relative to the housing (111), the stopper (113) remains stationary relative to the housing, so that the movement of the socket (118) causes movement of the outlet (114) relative to the stopper (113).

2. An automatic injector according to claim 1, wherein the socket (118) is configured to bring the container (119) into engagement with the outlet (114), with the possibility of transferring the fluid, when the outlet is located adjacent to the stopper (113).

3. An automatic injector as claimed in claim 1 or claim 2 further comprising: a mixing member (121) coupled to the socket (118) and is designed to be displaced by the socket (118) in such a way that the exhaust port (114) is displaced from the traffic jam (113).

4. An automatic injector according to claim 2 or claim 3, wherein the engagement between the container (119) and the release roller (114) forms a fluid channel for moving the fluid from the container (119) to the camera (112).

5. An automatic injection device according to any one of the preceding claims, further comprising an injection head (115) in conjunction with a fluid medium with an outlet (114).

6. An automatic injector as claimed in claim 5, wherein the container (119) comprises a lid (120), and wherein the injection needle (115) is made to pierce the lid (120) to form a channel for fluid to move the fluid from the container (119) into the camera (112).

7. An automatic injection device according to any of the preceding claims, further comprising a second subunit (210) comprising:

a disengaging drive mechanism (212) adapted to move in relation to the stopper (113) when actuating the drive mechanism (212).

8. The automatic injector of claim 7, wherein the disruptive actuator (212), when actuated, is designed to:

(a) moving the chamber (112) and the injection needle (115) from the retracted position in which the needle (115) is completely inside the body (111) in a position in which the needle (115) is at least partially out of the body ( 111); and

(b) then moving the plunger (111) inside the chamber (112) towards the outlet (114) with the propagation of the fluid from the injection needle (115).

9. An automatic injector according to claim 8, further comprising a retraction mechanism, made with the ability to pull the injection needle (115) into the housing (111) after the fluid has been pushed out.

10. An automatic injection device according to any one of the preceding claims. 7-9, in which: the first subwoofer (110) is disconnected from the second sub-node (210); and the second subwoofer (210) is reusable.

A method for preparing an automatic injector having a first sub-assembly (110) containing a housing (111), the method comprising the steps of:

inserting the container (119) into the socket (118) on the injector, wherein the socket (118) is movable relative to the housing (111) and the first subwoofer (110) comprises a chamber (112) having an outlet (114) , movably located inside the camera (112), where the camera (112) is connected to the socket (118) so that the movement of the socket (118) causes the corresponding movement of the chamber (112) and outlet (114) relative to the housing (111) when the socket (118) and the camera (112) move relative to the housing (111), the stopper (113) remains stationary relative to the housing (111), so that the movement of the socket (118) causes a change forgiveness outlet (114) vidnosnoprobky (113);

moving the jaw (118) into the body (111); and

moving the jack (118) from the housing (111) in such a way that the fluid is drawn into the camera (112) from the container (119).

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Computer layout by G.Payalnikov

State Service of Intellectual Property of Ukraine, st. Uritskogo, 45, Kyiv, SME, 03680, Ukraine

State Enterprise "Ukrainian Institute of Industrial Property", st. Glazunova, 1, Kyiv - 42, 01601

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