RU2531650C2 - Dual-chamber disposable syringe - Google Patents

Dual-chamber disposable syringe Download PDF

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Publication number
RU2531650C2
RU2531650C2 RU2013128738/14A RU2013128738A RU2531650C2 RU 2531650 C2 RU2531650 C2 RU 2531650C2 RU 2013128738/14 A RU2013128738/14 A RU 2013128738/14A RU 2013128738 A RU2013128738 A RU 2013128738A RU 2531650 C2 RU2531650 C2 RU 2531650C2
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RU
Russia
Prior art keywords
syringe
air
vial
chamber
needle
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RU2013128738/14A
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Russian (ru)
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RU2013128738A (en
Inventor
Владимир Алексеевич Небольсин
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Владимир Алексеевич Небольсин
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Priority to RU2013128738/14A priority Critical patent/RU2531650C2/en
Publication of RU2013128738A publication Critical patent/RU2013128738A/en
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Abstract

FIELD: medicine.
SUBSTANCE: dual chamber disposable syringe comprises a hollow cylindrical body wherein there are coupled piston and stopped rod; the piston hermetically divides an internal volume of its cylindrical cavity into a fluid chamber and an air chamber by the fact that its proximal end is hermetically closed by a finger stop flange and a seal; a distal end of the syringe comprises two axial cones for two hollow injection needles in parallel to each other, or one dual needle with two passages; the air chamber is connected through the axial cones to an air chamber by an external air passage formed by a plastic pipe; a needle used for the air passage is longer than a withdrawal needle; the sealing flange on a dead end of the syringe is configured to align the rod; the syringe is made from the same material that is used for making a common disposable syringe.
EFFECT: using the invention enables providing the fluid flow with pressure balancing and maintaining the system integrity and performing an injection without additional training of the medical staff.
2 cl, 3 dwg

Description

The present invention relates to the field of medical equipment, and in particular to devices for moving fluids with pressure equalization, and can be used in their manufacture.

In medical practice, the parenteral method of administering drugs is widely used, which is indispensable for emergency care, as well as for conservative treatment due to the speed and lack of influence of digestive enzymes on drugs.

Many pharmaceutical preparations for injection come in the form of a dry powder, mainly in glass bottles. The neck of such a bottle is hermetically sealed with a punctured rubber stopper held by an aluminum closing element, the edges of which are bent over the stopper and the edges of the bottle. In order to extract a dry medicine for injection from such a bottle, it is necessary to add a solvent from another bottle immediately before use, into which a volume of air equal to the volume of liquid to be extracted must be introduced. To do this, pierce the stopper of the vial with the solvent attached to the syringe with a hollow injection needle, introduce air, which leads to an increase in pressure in it and the syringe, and, turning the vial with the stopper down, collect the required volume of liquid into the syringe. If air is not supplied to the vial prior to fluid withdrawal, then when the syringe piston moves toward itself, a vacuum will be created inside which will prevent the extraction of fluid from the vial.

Then, the syringe needle removed from the stopper of the solvent vial is injected into the dry matter vial in the same way and the liquid is pumped, while the pressure in the vial will also increase. The increased pressure tends to push the liquid out of the vial through the hole formed by piercing the cork with a syringe needle. After stirring with pumping movements to completely dissolve the dry substance, a homogeneous liquid solution is obtained, it is not recommended to shake the bottle, because this may cause air bubbles. The vial is lifted upside down and, having collected the necessary amount of solution into the syringe, the air that has got along with part of the drug is expelled from it into the vial, the needle is removed from the cork, and then an injection is made. When removing air from a syringe, it is not recommended to spray the solution into the environment, as daily inhalation of medicinal aerosols can lead to allergic reactions in exposed medical personnel.

The disadvantage of this method is that manufacturers leave a small part of the air inside the pharmaceutical liquid bottle, the solvent bottle is usually 80-85 percent filled with liquid, and the liquid is known to be incompressible, and to introduce an equal volume of air into the bottle the extracted fluid, you need to make a significant effort. The junior medical staff is mainly staffed by women, so difficulties may arise here. In addition, excess pressure in the vial tends to push part of a potentially hazardous fluid into the environment. It is necessary to exclude pollution of the ambient air, which can occur if the smallest particles of powder or liquid escape from the bottle.

In the patents RU 2236834 C2 dated 09/27/2004, A61J 1/20, B65D 51/00; RU 2355377 C2 dated 05.20.2009, A61J 1/20, A61M 39/10; RU 2469696 C2 dated 12/20/2012, A61J 1/20 proposed to eliminate this drawback using various designs of transition devices, to which two bottles are connected - with a powdered drug and a solvent, and a syringe for injection. Such devices are equipped with an air channel that equalizes the pressure in the vessels when mixing the preparations and moving the fluid, eliminating rarefaction or overpressure inside the bottle. However, such devices are quite complex and expensive and require special training of medical staff. When using the device, errors due to incorrect connection of containers are possible. Medical preparations of various manufacturers are supplied in containers of various volumes, the capacity of syringes also varies, and the device provides connecting modules designed for certain parameters. In addition, the device is not disposable and requires sterilization, but due to the spread of especially dangerous diseases transmitted by blood, only disposable injection devices are used all over the world. These shortcomings force medical staff to use regular disposable syringes for daily injections.

The aim of the invention is to develop an inexpensive, easy to manufacture and use universal device for moving fluids with pressure equalization while maintaining the integrity of the system and injection, which does not require additional training of medical personnel.

The solution of the technical problem is provided by the fact that the claimed invention proposes to use a disposable two-chamber syringe as a sterile sealed system used when moving fluids with pressure equalization and injection. Two-chamber syringes were offered, for example, in US Pat. Nos. 4,655,747 (A) of 04/07/1987, A61M 5/19, A61M 5/28; US20081515012 (A1) dated 09/04/2008, A61M 5/19; WO 2012012784 (A1) dated 01/26/2012, A61M 5/19, however, here they are used as a device for long-term storage of solution components in separate chambers and for injection in case of emergency in the field or in combat conditions, which significantly increases their cost. In addition, when a dry substance of a medicinal product is placed in a piston cylinder, part of the air space is always stored in it, and air is not provided for in the descriptions of these patents.

The closest in technical essence to the claimed invention are a conventional disposable syringe, for example, TU 9398-001-28994901-2009, and presented in patent JP 2002238979 (A) from 08/27/2002, A61J 1/20, A61J 3/00 symmetrical two-pointed needle providing simple and quick preparation of a medicine from a powder preparation. One end of such a needle is inserted into a vial with a solvent, the other into a container with a dry preparation. The symmetric needle has a fluid channel passing through one and the other parts of the needle, as well as an air channel equipped with an opening to which delivery and suction devices can be connected.

The essence of the claimed technical solution is illustrated by a description of an example of its preferred implementation with reference to the accompanying drawings. The same item numbers are used throughout the description and in all drawings to refer to the same components and parts. Numbering is made in the order of mention in the description.

Figure 1 presents a longitudinal section of the specified syringe, side view; figure 2 shows a bottle of liquid into which two syringe needles are inserted; figure 3 shows a longitudinal section of a variant of the syringe with a rigid external air channel, side view. The specified syringe differs from the usual disposable in that the piston 1, made with the possibility of reciprocating movement, divides the internal volume of the cylindrical cavity 2 into the liquid 3 and air 4 chambers due to the fact that its proximal end open at the usual syringe is hermetically closed by a flange 5 with finger rest 6 and seal 7. At the distal end of the syringe there are two conical tips 8 and 9 for securing two hollow injection needles 10 and 11 with relatively sharp ends parallel to each other and the air chamber 4 through the conical tips 12 and 13 is connected to the conical tip 9 by an external air channel 14 formed by a flexible plastic tube similar to that used in droppers. The piston 1 by the rod 15 is connected to the rod stop 16.

The terms "proximal" and "distal" representing the parts of the syringe are used in this description with respect to the medical worker making the injection.

According to the invention, a two-chamber syringe works as follows: two parallel needles 10 and 11 are put on the conical tips 8 and 9 of the syringe, with which the rubber stopper 17 of the bottle 18 with liquid 19 is pierced to establish a message with the contents of the bottle. In this case, the two chambers of the syringe 3 and 4 and the capacity of the bottle 18 are combined into a sealed system. The total volume of these three cavities is unchanged for any position of the piston 1, the movement of which simultaneously regulates the volumes of the liquid 3 and air 4 chambers, so there will be no excess pressure or vacuum in the bottle. There is no need to inject atmospheric air into the syringe in the volume equal to the volume of the extracted liquid before puncturing the stopper of the vial of liquid; you can immediately draw the drug into the syringe. All manipulations with the liquid in the bottle are performed in its upside down position, as shown in FIG. 2, the needle of the air channel should be longer than the needle of the liquid channel so that the air leaving it does not create air bubbles in the liquid. When collecting the dissolved drug, the piston 1 of the syringe is pulled out by the rod 15, increasing the volume of the liquid chamber 3 and creating a vacuum in it, under which the drug from the vial 18 passes through the needle 10 and tip 8 into the chamber 3. In this case, the air chamber 4 decreases by exactly this the same volume, adding air to the bottle 18 through the tip 12, the external air channel 14, the tips 13 and 9, and the needle 11, equalizing the pressure drop and thereby preserving the atmospheric pressure in the bottle at any position of the piston. Excess pressure or vacuum is created only in the liquid chamber 3 of the syringe, therefore, no particles or aerosols of the drug can escape from the vial into the environment. Thus, this device provides a closed sealed system for moving fluids with pressure equalization. In this case, the increase in pressure in the bottle as a result of the introduction of the liquid is compensated due to the selection of air due to the increase in the volume of the sealed air chamber, and the decrease in pressure in the bottle as a result of the selection of the recovered liquid from the bottle is compensated by its decrease.

The syringe needles removed from the stopper of the vial with the solvent are introduced into the vial with the dry substance and the liquid is pumped, while the pressure in the vial does not increase. After stirring with swaying movements, a homogeneous liquid solution is obtained, having collected the necessary amount of the preparation into the liquid chamber of the syringe, the air that has gotten along with part of the solution is displaced into the vial, and the needles are removed from the cork. To administer the drug to the patient, the claimed design is used as a regular syringe, in which case the needle of the air channel is removed.

The syringe comes from the manufacturer in a sterile packaging in the position of the fully inserted piston, while the volume of the liquid chamber is close to zero, and the air chamber occupies the maximum possible volume filled with sterile air. After the introduction of two sterile syringe needles into the vial, a sterile sealed system is formed through a sterilized plug. During the injection, with the needle of the air channel removed, the volume of the air chamber expands, so the exit of contaminated air from it is impossible. Due to the lack of pressure relief, the device prevents the aerosol of the drug contained in the vial from entering the surrounding air, and due to the tightness and sterility of the system, bacteria from the environment enter the contents of the vial when removing the drug from the vial, therefore, when moving fluids with it, it is not required sterile box or cabinet.

A two-chamber syringe of the claimed design containing a volume control device located inside the cylinder is made of the same materials as a regular disposable syringe with slight changes in design and can be used by medical personnel without retraining. They will be able to mix drugs, move them and make injections with the usual movements, but now without undue effort. The transparent cylinder of the device allows you to control the introduction of medicines, serves as a visible indicator of the remaining amount of fluid. The device is applicable to vials and syringes of any shape and size in various combinations. There is no need for two jumpers crossing at right angles on the rod, because The centering function of the stem is the sealing flange at the proximal end of the syringe. To tightly close the proximal end of the cylinder, the piston can be collapsible: the rod stop 16 can be screwed onto the rod 15 or fixed in another way. Alternatively, instead of two needles 10 and 11, one twin needle with two channels can be used, in which case it is replaced by a separate injection needle fixed to the tip of the fluid channel for injection. If necessary, a filter inserted into the cut of the external air channel can be used. To increase the compactness of the device, a variant is possible with a rigid external air channel 20 located on the outer surface of the syringe body, as shown in Fig. 3.

The present invention provides a device that is easy to manufacture and use, used to transfer medical fluids between the vials and the syringe and to administer an injection, which ensures, by creating a sealed system, pressure equalization and aerosol retention when accessing the vial with a punctured seal. Due to the external air channel, the specified device controls the volume by automatically adding the necessary amount of air to the bottle or removing it. Thus, the device according to the invention provides a closed airtight system designed to dilute the contents of the vial and select the resulting preparation for use by injection for patients, which delays the aerosols of the drug when accessing the vial. When solvent is added to the vial, the air inside the vial is forced out by the added solvent into the air chamber, not allowing the particles of the drug to pollute the environment. When a medicine is removed or aspirated from a vial, air from the air chamber is drawn into the inner space of the vial, equalizing the air pressure in the vial with the surrounding atmosphere, preventing bacteria and particulate matter contained in the air from contaminating the inner space of the vial.

The essence of the claimed invention lies in the fact that a low-cost, simple to manufacture and use universal device for moving fluids with pressure equalization while maintaining the integrity of the sterile system and injection is developed, which uses a disposable two-chamber two-needle syringe, the proximal end of which is hermetically closed by a flange with seal. At the distal end of the syringe, two hollow injection needles are arranged parallel to each other, and the air chamber is connected to the air needle by an external air channel.

The technical result of the claimed invention is the use for moving fluids and injecting a sterile sealed system that does not require additional training of medical personnel.

The specified technical result is achieved due to the fact that a low-cost, simple to manufacture and use universal device for moving fluids with pressure equalization while maintaining the integrity of the sterile system and injection is developed, which uses a disposable two-chamber two-needle syringe, the proximal end of which is hermetically closed by a flange with seal. At the distal end of the syringe, two hollow injection needles are arranged parallel to each other, and the air chamber is connected to the air needle by an external air channel.

New significant features of the claimed invention are:

- use for moving fluids and injecting a sterile sealed system that does not require additional training of medical personnel;

- use as a device for moving fluids with pressure equalization while maintaining the integrity of the sterile system and injecting a disposable two-chamber two-needle syringe;

- the piston hermetically separates the internal volume of the cylindrical cavity into the liquid and air chambers due to the fact that its proximal end is hermetically sealed by a sealing flange;

- at the distal end of the indicated syringe, two hollow injection needles are arranged parallel to each other, and the air chamber is connected to the air needle by an external air channel.

This description and drawings do not limit the scope of the invention and are intended to sufficiently disclose information, are an example embodiment of the invention, and although the preferred options for its implementation have been presented above, it should be understood that the present invention is not limited to the variations and modifications described herein, the present description is rather illustrative than restrictive. A person skilled in the art can envision numerous changes and additions to the form and details in accordance with the information disclosed herein, as well as other embodiments of the present invention without departing from the spirit and scope of the invention as defined by its claims. Any of the above structural elements can be used in combination or separately to achieve all or some of the advantages of the invention. Therefore, any changes regarding the shape, type, size, materials and elements of the claimed device should be considered as equivalent embodiments of the present invention, if they do not constitute the subject of a new invention and do not make significant changes to the prior art.

Comparison of the claimed technical solution with the prior art in scientific, technical and patent documentation as of the priority date in the main and related sections shows that the set of essential features of the claimed solution was not known - therefore, it meets the patentability condition of “novelty”.

Analysis of the known technical solutions in the art showed that the proposed device has features that are not in the known technical solutions, and using them in the claimed combination of features makes it possible to obtain a new technical effect, therefore, the proposed technical solution has an inventive step compared to the existing level technicians.

The proposed technical solution is industrially applicable, because can be manufactured industrially, efficiently, feasibly, reproducibly, therefore, meets the patentability condition "industrial applicability".

Claims (2)

1. A disposable two-chamber syringe containing a hollow cylindrical body in which are connected a piston and a rod with a stop, characterized in that the piston hermetically separates the internal volume of its cylindrical cavity into a liquid and air chamber due to the fact that its proximal end is hermetically closed a flange with an emphasis for fingers and a seal, at the distal end of the syringe there are two conical tips for two hollow injection needles located parallel to each other, or one twin needle with two channels lamas, and the air chamber through the conical tips is connected to the air needle by an external air channel formed by a plastic tube; the needle used for the air channel is longer than the needle for collecting fluid, the sealing flange on the blind end of the syringe is made with the possibility of centering the rod, while the syringe is made of the same materials as a regular disposable syringe.
2. The method of using the disposable two-chamber syringe according to claim 1, comprising piercing the rubber stopper of the bottle with liquid with two parallel needles fixed on the conical tips of the syringe, while the two chambers of the syringe and the capacity of the bottle are combined into a sealed system, the movement of the piston simultaneously controls the volumes of liquid and air chambers, thereby preserving the atmospheric pressure in the vial at any position of the piston, overpressure or vacuum are created only in the liquid chamber of the syringe, therefore, no particles or aerosols of the drug cannot escape from the vial into the environment, the increase in pressure in the vial as a result of fluid injection is compensated by the increase in the volume of the sealed air chamber, and the decrease in pressure in the vial as a result of fluid withdrawal from the vial is compensated by its reduction; when liquid is added to the vial, the air from the vial is forced into the air chamber, not allowing the particles of the medication to pollute the environment, when the medication is removed or sucked out of the vial, the air from the air chamber is drawn into the inner space of the vial, aligning the air pressure in the vial with the pressure of the atmosphere, allowing bacteria and substance in the form of particles contained in the air to contaminate the inner space of the vial, for the introduction of the drug to the patient, the claimed design is used It is used as a regular syringe, in this case the needle of the air channel is removed.
RU2013128738/14A 2013-06-24 2013-06-24 Dual-chamber disposable syringe RU2531650C2 (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3957051A (en) * 1974-09-13 1976-05-18 Medical Development Corporation Pump-type syringe having double-acting piston construction
WO1996029113A1 (en) * 1995-03-20 1996-09-26 Medimop Medical Projects Ltd. Fluid control device
RU2150879C1 (en) * 1998-05-26 2000-06-20 Савушкин Александр Васильевич Disposable capillary syringe-viscosimeter for investigation of biological liquids
EP1520597A1 (en) * 2003-09-30 2005-04-06 3M Espe Ag Syringe assembly
EP2133059A2 (en) * 2004-04-29 2009-12-16 Medimop Medical Projects Ltd. Liquid drug medical device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3957051A (en) * 1974-09-13 1976-05-18 Medical Development Corporation Pump-type syringe having double-acting piston construction
WO1996029113A1 (en) * 1995-03-20 1996-09-26 Medimop Medical Projects Ltd. Fluid control device
RU2150879C1 (en) * 1998-05-26 2000-06-20 Савушкин Александр Васильевич Disposable capillary syringe-viscosimeter for investigation of biological liquids
EP1520597A1 (en) * 2003-09-30 2005-04-06 3M Espe Ag Syringe assembly
EP2133059A2 (en) * 2004-04-29 2009-12-16 Medimop Medical Projects Ltd. Liquid drug medical device

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