RU137197U1 - CONTAINER FOR INFUSION SOLUTIONS AND / OR BLOOD - Google Patents

Abstract

1. A container for infusion solutions and / or blood, which is a container consisting of a body with an internal cavity, characterized in that the container body is made of polypropylene material and a channel is introduced into it for evacuating and filling with an infusion solution, a tube, the outer side of which there is a tongue for cork sterility, a rubber sealant is located on its inside, a neck is inserted, moreover, it is made integral with the internal cavity of the container and is located in the center of the lower part of the housing, and a thin partition has a rubber seal with the possibility of contact with it, while the plug is seated on the neck and is rigidly connected to it. 2. The container for infusion solutions and / or blood according to claim 1, characterized in that in the upper part of the casing there is a loop for hanging the container when using it in conjunction with a channel for evacuating and filling with infusion solution.

Description

The utility model relates to the field of medical technology, namely to devices for the infusion of blood and other medical solutions, in particular to containers for storing, transporting in a wide temperature range of blood, its substitutes and infusion solutions, and can be used for infusion of blood, its components and other infusion solutions.

The famous "Container for blood and its components" (Copyright certificate No. 854399 of the USSR, IPC A61M 5/14), which is a reservoir of elastic film with sealing seams, equipped with tubes and fittings, each of which is enclosed in a protective shell with a tear-off petal, wherein the protective sheath is made of a "sleeve" film.

The disadvantages of this design of the known blood container and its components include the difficulty in use, and its manufacturing technology requires a sufficiently large amount of elastic material, and when sterilizing this container various toxic substances are released into the solution, which is unsafe and harmful to the patient, and then a container of this design is ineffective from all points of view.

The closest in technical essence to the claimed utility model and taken as a prototype is a "container for blood and or blood components" (RF Patent No. 2284807, IPC A61J 1/05, publ. 10.10.2006), containing a container consisting of a housing, containing the front and back sides, and the internal cavity; the front and / or back side of the container body contains at least two regions with different tensile strengths, the front side of the container body is connected to the back side of the container body through at least one connecting seam; and at least one tube connected to the container’s internal cavity is connected to the container body.

The disadvantages of this container design include the difficulty in use, as well as the complexity of manufacturing. A sufficiently large amount of elastic material is required, which is due to the manufacture of a container, which is a container consisting of several layers of elastic material. The manufacture of the container design is laborious in connection with the manufacture of layers with different strength values. Opening the container is difficult when placing it inside another elastic sealed container, moreover, various types of microorganisms can enter the opened hole, which reduces hygiene and poses a danger to the patient. When manufacturing a container from a plastic film during thermal sterilization of solutions and / or blood for no more than 5 minutes only vegetative forms of microorganisms die, and the spores themselves do not die, at the same time, when solutions and / or blood are sterilized from a plastic film, various toxic substances, which is unsafe for the patient when using such a container. All this makes the design of this container complex and inefficient.

The technical result is the creation of a container structure made of polypropylene, providing a high degree of sealing and sterility.

The technical result is achieved by the fact that in the container for infusion solutions and / or blood, which is a container consisting of a body with an internal cavity, the container body is made of polypropylene material and a channel is introduced into it for evacuation and filling with an infusion solution, a plug, from the outside which has a tongue for cork sterility, a rubber seal is located on its inside, a neck is inserted, moreover, it is made integral with the internal cavity of the container and is located in the center of It body portion and a thin seal rubber septum mounted with the possibility of coming into contact with it, the plug is seated on the neck and is rigidly connected thereto.

In the upper part of the housing, at the same time with the channel for evacuation and filling with infusion solution, a loop is made for hanging the container during its use.

New is:

- thanks to the inventive design of the container made of polypropylene, high efficiency is achieved by providing sealing and sterility (the ability to sterilize infusion solutions with steam under pressure at 121 ° C for 20 minutes) during transportation, storage and use (infusion or transfusion), as well as technical characteristics as when releasing containers (production), and when simplifying the procedure for filling with an infusion solution (when folded under vacuum), without requiring an additional pumping system.

The essence of the utility model is illustrated by drawings:

Figure 1 - shows a General view of the container, figure 2 is a side view in the folded state, where:

1 - container body

2 - channel for filling the container with infusion solution

3 - neck with a thin partition

4 - cork

5 - rubber seal

6 - tongue

7 - loop

8 - scale

The container for infusion solutions and / or blood is a container consisting of a container body 1, a neck with a thin partition 3, a channel 2 for evacuation and filling with an infusion solution, the container body is made of polypropylene material, and the neck with a thin partition 3 is made integral with the inner cavity and is located in the center of it, and behind the partition there is a rubber seal 5 of the plug 4, on the outside of which there is a tongue 6 for sterilization, and on the other side of the plug is a rubber pack 5th extender, which is in contact with the thin partition 3, for stiffness, plug 4 is welded to the neck.

Container Operation:

In the container 1 through the channel for filling 2 pour the infusion solution to the desired level, then this channel is sealed. Due to the fact that the container 1 is made of polypropylene and is a soft construction, it can be used for storage in the folded state of the prepared containers in warehouses under vacuum. When using containers with an infusion solution for infusion, remove the tongue 6 on the plug 4 firmly sealed (soldered) on the neck of the body, providing access to the rubber seal 5. The needle of the system is inserted into the container 1 through the rubber seal 5 and the thin partition 3 of the container neck, without violating tightness and sterility physical. solutions. The container is suspended on a loop 7. The system is ready for operation.

Example: The inventive design was made of polypropylene, filled with water for infusion and autoclaved with steam at a pressure of 1.1 atm at a temperature of 121 ° C for 20 minutes. Toxicological tests of the infusion solution were carried out for irritation, acute toxicity, sterility, pyrogen-free and harmful impurities in accordance with GOST R 5 1148-98 “Medical devices”, GN 2.33.972-00 “MPC of chemicals released from materials”.

Test results No. Name of indicator Valid Values Test results findings one Reducing impurities Not more than 1.0 m (0.02 N sodium thiosulfate solution) 0 Acc. 2 PH measurement No more than (±) 1,0 0.37 Acc. 3 Ultraviolet absorption Not more than 0.3 (diap. 230-360 nm.) 0.005 Acc. Toxicology Test Results Irritant effect on the skin and mucous membranes of animals in points Leather 0 0 Acc. Rabbit mucous eyes 0 0 Acc. Acute toxicity in white mice with iv. Administered Mortality 1 no no No Acc. Clinical symptoms of intoxication no No Acc. Macroscopic changes in organs and tissues no No Acc. Weight coefficients of internal organs (presence of significant changes) no No Acc. Determination of hemolytic activity No more than 2% 0 Acc. Toxicity index 70 to 120% 113.2% Acc. The concentration of heavy metals in the extract from products: Copper Up to 1.0 mg / l 0.01 Acc. Lead Up to 0.03 mg / l 0.01 Acc. Chromium Up to 0.1 mg / l 0.01 Acc. Cadmium Up to 0.001 mg / l 0.0001 Acc. Barium Up to 0.01 mg / l 0.01 Acc. Tin Up to 0.01 mg / l 0.01 Acc. Formaldehyde Up to 0.01 mg / l 0 Acc. one Sample sterility and pyrogen-free data Sterility Sterile Sterile Acc. Pyrogen-free pyrogen-free pyrogen-free Acc.

Conclusion

Polypropylene container with intravenous solution port

Non-toxic, compliant with regulatory requirements

The test results showed that the infusion solution in the inventive container is non-toxic, sterile and pyrogen-free.

According to its technical and economic advantages, in comparison with the known analogues, the claimed utility model has several advantages,

firstly: in comparison with plastic and polyvinyl chloride containers during sterilization, in the inventive polypropylene container there will be a decrease in the diffusion of toxic substances into the infusion solution, which will increase safety in general;

secondly: in comparison with containers made of elastic film, the inventive container made of polypropylene can be used in the form of preforms of semi-soft containers for the production and storage of them in a folded state under vacuum in sterile bags. At the same time, the possibility of storage in the folded state ensures the economical use of storage space volumes, and in case of stopping the machine by blowing containers for any technical reasons, the flow line for filling solutions will not be stopped, because The claimed utility model makes it possible to produce a stock of containers when folded under vacuum, which leads to large production savings;

thirdly: the design of the inventive container, consisting of a body of polypropylene material, a neck with a thin partition, a channel for evacuation and filling, plugs with a tongue and rubber sealant - all this allows without additional adapters to increase tightness and sterility both at the storage stage and at the stage of application of the system as a whole, which increases patient safety;

fourthly: the presence of a tongue located in the cork, which is removed during use, thereby guaranteeing the sterility of the cork when pierced with a medical needle and also increase the efficiency of use, because no antiseptic agents are needed to treat the cork;

fifthly: simplification of the procedure for filling the container body with an infusion solution under the action of a vacuum, which is in the container in the folded state, which does not require an additional pumping system.

All of the above makes the claimed design of the container effective.

Claims (2)

1. A container for infusion solutions and / or blood, which is a container consisting of a body with an internal cavity, characterized in that the container body is made of polypropylene material and a channel is introduced into it for evacuating and filling with an infusion solution, a tube, the outer side of which there is a tongue for cork sterility, a rubber sealant is located on its inside, a neck is inserted, moreover, it is made integral with the internal cavity of the container and is located in the center of the lower part of the housing, and a thin partition is installed with a rubber sealant with the possibility of contact with it, while the cork is seated on the neck and rigidly connected to it. 2. The container for infusion solutions and / or blood according to claim 1, characterized in that in the upper part of the casing there is a loop for hanging the container when using it in conjunction with a channel for evacuating and filling the infusion solution.

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