RU2709511C1 - Device for storage, transportation, decontamination of preserving agent and use of biological fluid - Google Patents

Abstract

FIELD: biotechnology.

SUBSTANCE: invention relates to biotechnology, medical equipment, and can be used for storage, transportation of liquid biopreparations in solutions of preserving agents, which are toxic liquids of various hazard classes, and their deactivation before direct application of biopreparations. Device comprises cover with central hole on its upper platform and screw thread of PET type, made of ductile resilient plastic material, in which a cylindrical-shaped bushing is inserted from below upwards and made of plastic elastic plastic material, having in its middle part a sealing disc and an annular gasket made of resilient elastic material, which adjoins the bottom surface of the sealing disc along its entire length. In lower part of bushing dosing plug is installed bottom-down, having on outer side surface annular elastic ribs, dosing plug from above is covered with protective plate of round shape, made of resilient elastic material. In the upper part of the bushing there is a piston on the rod, made of ductile elastic plastic material, in the middle, external part of the stock there are at least two symmetrically arranged limiting lobes, preventing drop of the rod into the container when pressing from top to bottom, and the stock itself along the entire length has an internal channel for liquid withdrawal from the container, which ends in the upper end with a nozzle connection of the LUER slip type, intended for the plug attachment with the LUER lock type connection made of elastic plastic material. From the outside, the outer part of the rod with the plug is closed with a protective detachable cap made of a dense resilient plastic material.

EFFECT: preserving sterility within container and at outlet of nozzle inner channel, safety when working with poisonous preserving liquids, guaranteed neutralization of preserving agent with preservation of initial properties of biopreparation.

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Description

The invention relates to biotechnology, medical equipment, and can be used for storage, transportation of liquid biological products in preservative solutions, which are toxic liquids of various hazard classes, for example: alkali, acids, or other chemicals and their deactivation before the direct use of biological products.

It is known that biological products obtained from biological fluids of the human body and mammals have a limited shelf life at temperatures ranging from 20 ° C-22 ° C and can be used for no more than 4-6 hours after their preparation. The main reason for this is the progressively increasing process of degradation of protein and biopolymer structures of biological fluid outside the body, up to their complete denaturation. The addition of preservatives in order to protect against microbial cantamination does not prevent this process, since it is associated with the natural, biologically determined breakdown of biopolymers both inside and outside the body, which is temporarily limited. So, for whole blood this time period is no more than 6-8 hours, for individual native preparations obtained on its basis, in particular, such as cryoprecipitate, blood plasma, up to 8-10 hours. For individual native biological products, this time threshold is somewhat larger, but practically does not exceed 24 hours. (Appendix to the order of the Ministry of Health of the Russian Federation No. 193 of 05/07/2003, "On the implementation of the method of quarantining freshly frozen plasma in the practice of the blood service in the Russian Federation") (1). In addition, the transportation of biological products adversely affects their quality, as it contributes to precipitation and a decrease in the initial biological properties.

This situation significantly limits the possibility of long-term storage and use of biological products for direct use, their transportation, which is not only important medical and social value, but also entails significant economic losses associated with the need for urgent disposal of unused biological products.

One of the common ways to prolong the storage and use of biological products is their lyophilization, which can significantly increase the time of their biological preservation, up to 1-2 years (2). At the same time, it should be noted that the main disadvantage of freeze drying of biological products is a significant decrease in their biological properties and, of course, their effectiveness. One of the side effects of the use of lyophilized biological products is pyrogenic and a variety of immune reactions associated with a high content of denatured highly labile proteins or biopolymers denaturing during cold low-temperature drying, usually at - (45 + 5) ° С and below (3.4 )

It is known that many biological products can retain their biological properties for a long time only when stored in special solutions of preservatives, which in most cases are toxic liquids. By a toxic liquid is meant strong acids, alkalis, other chemically active substances with a high hazard class. Their use poses a threat to both the user and the personnel who come in contact with them. In addition, there may be a risk of unauthorized or accidental use of a biological product without prior deactivation of the preservative, which also poses a direct threat to the health of persons associated with the use of these biological products.

The aim of the invention is a device for the safe storage and transportation of biologically active substances in solutions of preservatives that are toxic substances, which before direct use allows you to neutralize the toxic preservative, eliminate the threat of contact with the user, while maintaining the biological properties of the biological product.

A device for storing and transporting water (5), equipped with a housing with a removable cover for water inlet, an outlet hose for water, size 48 × 18 cm and weighing 500 g.

A similar device for storing and transporting water (5) is known, equipped with a housing with a removable cover for water inlet, an outlet hose for water, with a built-in cylinder for pumping air to create excess pressure in the device and water outlet under pressure.

Common disadvantages of the described devices (5) and (6) are:

1. The lack of safety of sterility in preparation for the use of the device itself and the output fluid.

2. The inability to implement the preservation of sterility in this device design.

3. The difficulty of refueling it, the inability to use this design to introduce fluid to the patient.

4. The lack of a dispenser for a reagent that allows you to neutralize the preservative of biological fluid.

5. The difficulty of introducing fluid into the container.

Known dispenser of medicinal solutions (7), containing a hollow body with a device for fixing needles, a piston with a drive for interaction with the reservoir and the control system. To eliminate the risk of air embolism, it is equipped with a cylinder covering the reservoir. The disadvantages of this device are improper design complexity and multi-stage preparation for work, as well as the inability to use the existing dispenser for powdered reagents.

A separate group for comparison as analogs is made up of dispenser caps for PET containers. These elements are widely used in everyday life. The main material for their production is polypropylene, which has high characteristics for wear resistance and deformation. The main types of dispenser caps are as follows:

1. Trigger guns (triggers). These devices are designed for fine spraying of washing and cleaning substances. By their design they are a piston type pump, which is fixed on the bottle as a cap (cap). A single dosage is 1-2 ml.

2. Pump dispensers. They are used for dosing viscous substances of various types (detergents, liquid soaps, food products). Depending on the design, they can be membrane, plunger or peristaltic. Moreover, any model should be made of a material with high chemical resistance.

3. Push-button atomizers (microsprays). These covers (caps) are a simplified analogue of a trigger and perform only the function of fine atomization. Available in two types: screw-shaped and stamped.

4. Mini triggers. In terms of their functionality, they perform the same tasks as large atomizers. The main difference is the compact size and the ability to pump materials of high viscosity (cosmetic oils, aerosols, disinfectants).

5. Vertical dispensers. These devices operate on the basis of the principle of equality of fluid pressure and communicating vessels. The main area of their application is cosmetology, as they are able to pass through viscous and viscous materials.

The scope of all of the above types of dispenser caps is included in the package of industrial devices and household chemicals, applies to bottles for drinking water equipped with a cap dispenser, bottles with liquid soap in the department of hygiene products, mini-triggers as a means of caring for domestic plants. As specific examples, reference may be made to the following:

Known cap-dispenser for liquid (8), having a PET-type cap with a central hole through which a stationary rod passes with an internal channel providing a through passage of fluid from the tank. The top is equipped with a protective cap.

Known cap dispenser SPORT-KAP 1881 (9), having a PET-type cap with a central hole through which a movable rod passes with an internal channel providing a through passage of fluid from the tank. The top is equipped with a protective cap.

All of the above types of dispenser caps and their analogues are not intended for use in medicine, have the following disadvantages or design features that preclude their use for the realization of the goals set by us in the device, namely:

1. The lack of a piston rod.

2. The lack of dispenser-containers for bulk powdery substances.

3. Designed for liquid substances.

4. Not intended for use with liquid toxic substances.

5. There are no fitting connections that could provide the subsequent connection of the line or syringe.

6. The inability to preserve sterility in preparation for the use of the device itself and the output fluid.

7. The inability to implement the preservation of sterility in this device design.

Closest to the claimed features is a dispenser for liquid soap (10), selected for the prototype, consisting of a cover with an internal thread of the PET type, a central hole through which a rod with a piston at the lower end, sliding along the inner surface of the sleeve, a spring for a return stroke a piston and a plastic line falling to the bottom of the tank. Outside, a protective cap is put on the dispenser cover. When pressing on the outer upper part of the rod, the piston squeezes the air inside the container, from where liquid soap flows through the plastic line into the inner channel of the rod and further up. The design features of this device (Fig. 1) exclude the possibility of its use according to the following features we declare, namely:

1. Not intended for use with liquid toxic substances.

2. The absence of a metering plug for placement of a reagent in it to neutralize a biological fluid preservative.

3. The lack of tightness for the metering tube, eliminating premature and spontaneous contact of the reagent with the liquid in the tank.

4. The lack of design conditions for creating and maintaining sterility of the reagent and liquid inside the tank.

5. Lack of structural parts (choke connection) allowing connection to the choke connection device of the LUER lock type for subsequent connection of the line or syringe.

6. The absence of structural parts that exclude the possibility of using a plug, which could ensure the preservation of sterility in the outer part of the internal channel of the fitting.

7. The lack of constructive use of this device for bulk, powdery reagents.

8. The presence of a tight connection between the piston and the sleeve on top and bottom of the piston, creating a closed chamber, eliminating the possibility of installing a cork-dispenser.

The present invention has features that are different from analogues and prototype, which eliminates the above disadvantages as follows:

1. The device provides safe storage, transportation and use of biologically active substances in solutions of preservatives that are toxic substances.

2. The design of the device allows you to neutralize the toxic preservative before direct use, while maintaining the biological properties of the biological product.

3. The design of the device eliminates leakage of toxic liquid from the tank without prior neutralization.

4. The rod of the device is equipped with petals that prevent the piston from falling into the tank when pressing externally on the rod during operation.

5. The device ensures the complete safety of the user and personnel during the application and work with toxic substances inside the tank.

6. There is no need for additional decontamination of the container and device after use during disposal.

7. Simplicity of design and availability of components.

8. The simplicity of the assembly process and operation of the device.

9. The possibility of mass industrial production.

10. Allows you to ensure long-term operation for at least 2 years.

11. Allows reuse.

12. Full import substitution.

The main technical characteristics of the proposed device are disclosed below.

The composition of the device.

The proposed device consists of a cover 1 with a central hole of a circular shape on its upper platform and a screw thread of the PET type made of flexible plastic elastic material, for example polypropylene, polyethylene, etc., into which a sleeve 2 of a cylindrical shape made of plastic elastic plastic material, for example polypropylene, polyethylene, etc., having in the middle part a sealing disk 3 and an annular gasket 4 made of an elastic elastic material, adjacent to the entire m to the lower surface of the sealing disk 3. In the lower part of the sleeve 2 there is a metering plug 5 bottom-down, having annular elastic ribs 6 on the outer side surface, which ensure tightness and at the same time mobility inside the sleeve 2. At the same time, the metering plug 5 is covered with a protective top a rounded plate 7 made of an elastic elastic material that provides tightness for the safety of reagent 8 in the metering plug 5 used to neutralize the liquid. In addition, in the lower part of the sleeve 2 there is a piston 9 of the rod 10 made of flexible plastic elastic material, such as polypropylene, polyethylene, etc., designed to push the metering tube 5 with reagent 8 and a protective plate 7 into the container 11 when pressing from top to bottom on the upper outer part of the rod 10 located above the sleeve 2. Moreover, in the middle part of the rod 10 there are at least 2 symmetrically located limiting petals 12, preventing the rod 10 from falling into the container 11 when pressed and from top to bottom, and the rod 10 along its entire length has an internal channel 13 for withdrawing fluid from the tank 11, which ends at the upper end with a LUER slip type fitting 14 intended for fastening the plug 15 with a LUER lock type connection made of elastic plastic material , which ensures the tightness of the closing of the channel 13 of the rod 10. On top of the outer part of the rod 10 with the plug 15 is closed with a protective removable cap 16 made of a dense elastic plastic material.

The proposed device operates as follows

Preliminary, the device is getting ready for work, which is as follows:

The required pre-calculated amount of reagent 8 is poured into the metering plug 5, after which it is closed by a protective plate 7 and inserted into the lower part of the sleeve 2, where the rod 10 was previously inserted so that its piston 9 is in the upper part of the sleeve 2. Then the sleeve 2 assembly with an annular gasket 4, a metering plug 5, a protective plate 7, a reagent 8, and a rod 10 is inserted from the bottom up into the central hole on the cover 1 and tightly screwed with a PET screw connection to the neck of the tank 11, where previously Biological fluid with preservative has been poured for the proposed use. In this case, tightness is achieved by squeezing an elastic ring gasket on the lower surface of the sealing disk 3 of the sleeve 2. After that, a plug 15 having a fitting connection of the LUER lock type is screwed onto the upper end of the stem 10 having a fitting 14 of the LUER slim type. The preparation of the device for work is completed by putting on the protective cap 16 on the outer part of the sleeve 2, with the stem 10 protruding outward and the plug 15. In this state, the device is used to store or transport biological fluid with a preservative.

If it is necessary to use the device directly, the operator removes the protective cap 16, presses on the plug 15 on the rod 10, which goes down along the guide channel of the sleeve 2. At the same time, the restriction tabs 12 on the rod 10 abut against the upper outer part of the sleeve 2, protect the rod 10 from falling into the container, and the piston 9 of the rod 10 provides tightness with the wall of the sleeve 2 and at the same time pushes the metering tube 5 with reagent 8, covered by a protective plate 7, into the container 11 with liquid. After the chemical reaction of neutralizing reagent 8 with a liquid preservative in the container 11, the rod 10 returns to the initial position by the operator, removes the plug 15, instead of which an external syringe or line with the same Luer lock type connection is connected, and then they begin to use the device for its intended purpose.

After removing all the liquid from the container, the device is disposed of without the use of additional means of decontamination, which are not required for this in connection with the earlier neutralization of the preservative with reagent 8.

Illustrations to the description are provided in the Appendix and are shown in FIG. 1 and FIG. 2.

In FIG. 1 shows an image of a prototype dispenser for liquid soap.

In FIG. 2 shows the design of the claimed device, where the numbers indicate the positions:

1. Cover

2. Bushing

3. Sealing disc

4. Ring gasket

5. Cork dispenser

6. Elastic ribs

7. Protective plate

8. Reagent

9. Piston

10. Stock

11. Capacity

12. Boundary stem petals

13. The internal channel of the rod

14. LUER slim fitting

15. Stub

16. Protective cap.

Examples of the implementation of the device

Example 1

Assembly and use of the device for storage and transportation.

In PET container 11, with a volume of 50 ml, the operator pours the biological product with a preservative in the form of 0.1N NaOH (hazard class 8). Reagent 8 containing citric acid powder in an amount of 1.2 g is poured into the metering tube 5 of the device. based on the calculation of the neutralization reaction between NaOH and citric acid (followed by the formation of sodium citrate, a safe and non-toxic compound). Similarly, the entire batch of a biological product in an alkaline solution of a preservative is supplied with a stopper of a dispenser 5 filled with citric acid powder in the same volume. After that, the operator passes the sleeve 2 through the central hole of the cover 1, passes the rod 10 with the piston 9 through the sleeve 2, closes and inserts the metering plug 5 with reagent 8 with the plate 7 inwards, into the lower end of the sleeve 2. From above to the outer end of the rod 9, on the LUER slim 14 fitting connection inserts the plug 15, tightens the cover assembly on the PET neck of the container 11, after which the protective cap 16 is put on the cover 1 with the stem 10 and the plug 15 on top. In this state, the device and the entire similarly assembled batch of biological product are sent to the warehouse for x injuries and further transportation.

Example 2

Direct use of the device.

After receiving a task for the use of the device, the operator transports one of the devices to the destination, where he removes the protective cover 16, presses the plug 15 on the rod 10 with his finger, which goes down along the guide channel of the sleeve 2. At the same time, the restriction tabs 12 on the rod 10 abut against the upper the outer part of the sleeve 2, protect the piston 9 from falling into the container, and at the same time pushes the metering tube 5 with reagent 8, covered with a protective plate 7, into the container 11 with liquid. After the chemical reaction of neutralizing reagent 8 with a liquid preservative in the container 11, the operator returns the stem 10 to its original position, removes the plug 15, instead of which attaches an external syringe with a similar connection of the Luer lock type, and then proceeds to use the device for its intended purpose.

Example 3

Direct use of the device.

All stages of preparation for the intended use of the device are similar to those described previously in Example 2., except for the final operation, when instead of an external syringe, the operator connects an external line with a Luer lock type choke connection to the LUER slim type 10 device connection, and then proceeds to use devices for their intended purpose.

The present invention was explained in the above description in accordance with the above examples, not limiting the scope of the present invention. It should be considered that all options, including the following claims, are within the scope of the present invention.

Sources taken into account

1. Appendix to the order of the Ministry of Health of the Russian Federation No. 193 dated 05/07/2003, “On the introduction of the quarantine method of freshly frozen plasma” in the practice of the blood service in the Russian Federation.

2. A method of obtaining a lyophilized preparation hemolyzed blood. Patent RU 2455014. Authors: N.V. Sinitsyna, Yu.V. Ivanov, G.G. Krasichkov, A.K. Nikiforov N.I., Kostyleva, T.V. Alenkina.

3. Henderson L. O., Hazlehurst J.S., Taylor L., Harmon W.H. Preparation of lyophillzed human serum based reference materials with graded levels of apolipoproteins A-I and B. - Clin. Biochem. - 1988. - v. 21. - p. 219-223.

4. Matsuda Y. Factors affecting the biological activity of lyophilized myofibrils -protective substances and collapse temperatures, in: Fundamentals and applications of freeze-drying to biological materials, drugs and foodstuffs. -Proceeding of meeting of Commiss. Ci, Tokyo, May 20-22, 1985, Intern. Inst. Refrigeration, 1985, p. 103.

5. Drinking system PANTAC, company Milspeckiwi, USA.

6. Drinking system GeigerRig 2L, China.

7. Copyright certificate of the USSR No. 845756. Dispenser of medicinal solutions.

8. Cover-dispenser vertical, "Ukrtara", Ukraine.

Claims (1)

A device for storing, transporting, decontaminating a preservative and using biological fluid, including a lid with a hole, a rod with an internal channel, a protective cap, characterized in that it contains a lid with a central hole on its upper platform and a PET-type screw thread made of plastic elastic plastic a material into which a sleeve of a cylindrical shape is introduced, from the bottom up, also made of plastic elastic plastic material having a sealing disk and a ring in the middle part a gasket made of elastic material that is adjacent all the way to the lower surface of the sealing disk, and a metering plug is installed bottom-down on the outer side of the sleeve, having annular elastic ribs on the outer lateral surface, ensuring tightness and at the same time mobility inside the sleeve, the dosing tube is covered from above with a rounded protective plate made of elastic material that provides tightness for the safety of the reagent in the dosing tube used to deactivate the preservative of biological fluid, and in addition to this, a piston is mounted on the stem in the upper part of the sleeve, made of plastic elastic plastic material, designed for a tight movable connection between the sleeve and the outer surface of the piston, as well as for pushing the metering tube with the reagent and a protective plate in the container when pressing from top to bottom on the upper outer part of the rod located above and outside the sleeve, while in the middle, outer, part of the rod have there are at least two symmetrically positioned restriction petals that prevent the rod from falling into the container when pressing from top to bottom, and the rod throughout has an internal channel for taking fluid from the container, which ends at the upper end with a LUER slip type fitting intended for fastening the plug with LUER lock type connection made of elastic plastic material, which ensures tightness of the stem channel closure, and on top the outer part of the stem with a plug is closed with a protective mnym cap made of elastic dense plastics material.

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