RU236965U1 - Clamp for rubber tube - Google Patents

Abstract

The utility model relates to the field of biotechnology, pharmacy, medicine, in particular, to transfusiology, and can be used to control the flow of liquids into a container or soft-walled tube. A clamp for a rubber tube includes a housing and a channel for passing the rubber tube. On the side, on the end parts of the housing, there are two zigzag locks made with the possibility of opening with the formation of a slit for passing the tube into the opening for its placement, and in the center on the end sides of the housing - openings for placing the tube. The outer contour of the housing protrudes along one of the sides of the plane to such a height that after closing the locks, the upper plane will be parallel to the lower one. The inner contour of the housing has an oval shape, smoothly turning into a surface made for clamping the rubber tube and having the shape of a triangle. The use of the utility model provides an increase in its functionality. 2 fig.

Description

The utility model relates to the field of biotechnology, pharmacy, medicine, in particular, to transfusiology, and can be used to control the flow of liquids into a container and (or) plastic or rubber tubes, container lines (hereinafter referred to as the Tube).

When performing procedures in transfusion, biotechnology and other areas without the use of automation or in cases where the manufacturer did not provide for the closure of the Tubes when designing equipment or consumables, additional clamps are required. Such clamps provide the ability to regulate or completely block the flow of fluid in the Tube, which is especially important when performing transfusions, infusion therapy or dialysis, harvesting blood and (or) its components.

To date, various designs of clamps are known, including fixing elements that ensure clamping of a soft-walled tube. Such devices include devices for squeezing soft-walled tubes, disclosed in Russian patent 2617267, published 24.04.2017; in US patent 8474784, published 02.07.2013; in US patent 7758552, 20.07.2010.

However, known devices have a number of disadvantages, including the following:

- Damage to Tubes: Clamping mechanisms with sharp edges or rigid locking elements can damage soft-walled Tubes, which increases the risk of fluid leakage or compromises the tightness of the system;

- spontaneous slippage;

- difficulty in adjusting the liquid flow: known designs do not allow the clamp to be installed in any (required) place on the Tube, which limits the ability to fine-tune the liquid flow;

- design complexity: devices with a large number of small parts are difficult to manufacture and require additional production costs.

The development of a new clamp for soft-walled tubes (hereinafter referred to as the Clamp) is relevant due to the need to improve the reliability and ease of operation of medical products used in transfusiology and other areas of medicine.

The developed Clamp is detachable, has a simple design, accessible for industrial production, does not have structural elements that can damage the Tube, which allows eliminating the above-mentioned disadvantages of known devices for squeezing soft-walled tubes, combining ease of use, minimization of the risk of damage to the Tubes and flexibility of adjustment, which as a result improves its functionality.

The technical result, consisting in increasing the functionality of the clamping device, is due to the possibility of fixing the Clamp for closing the lumen of the Tube in the required place (outside the conditions of the Tube manufacturer), without damaging it and without using special equipment for sterile disconnection and connection of tubes, ensuring the closure of the lumen of the Tube without damaging it, including at any time during the procedure where this Tube is used, including without the need to interrupt the procedure, as well as the possibility of disconnecting, moving or repeatedly using the Clamp without damaging the Tube on which it is fixed.

The proposed Clamp can be used for:

1. Dosing of mononuclear cells.

Extracorporeal photopheresis, in particular the method of cryopreservation of mononuclear cells (RU Patent No. 2743816, published on 02/26/2021), is increasingly used to treat autoimmune diseases, cutaneous T-cell lymphomas, in solid organ transplants (to prevent transplant rejection, including lungs, heart, kidneys), and to treat acute and chronic forms of graft-versus-host disease.

In the method of cryopreservation of mononuclear cells, the mononuclear cell concentrate after photopheresis before programmed freezing is divided into parts (doses), each of which is poured into containers for cryopreservation in an amount sufficient to carry out the full or part of the course of prevention or treatment. It should be noted that the therapeutic effect does not depend on the number of mononuclear cells introduced in one procedure, which allows them to be used in the minimum permissible and (or) convenient doses for clinical use (for example, from 1 ml).

Features of this procedure:

– sterile conditions of the external environment are required, which are ensured by carrying out work in “clean zones” (rooms) or by using equipment that creates “clean zone” conditions (laminar box);

– dividing the mononuclear cell concentrate into doses requires the use of syringes and additional containers, which is accompanied by an increased likelihood of bacterial contamination of the mononuclear cell concentrate, an increased likelihood of erroneous distribution of the mononuclear cell concentrate between containers, the need to use additional consumables, and also requires significant time expenditure by medical personnel.

2. Dosing of blood components for use in children.

The procurement of donor blood components is carried out from each donor in the volumes required for transfusion to adults (the container volume is about 300 ml). However, the transfusion volume for children is calculated taking into account their body weight and averages 10-15 ml/kg (https://www.vair-journal.com/jour/article/view/233). For example, for the transfusion of red blood cell-containing components to a child weighing 2 kg, only 20-30 ml must be used. According to paragraph 99 of the Decree of the Government of the Russian Federation of 22.06.2019 No. 797 "On approval of the Rules for the procurement, storage, transportation and clinical use of donor blood and its components and on the recognition of certain acts of the Government of the Russian Federation as invalid": "In order to ensure safety, transfusions from one container to several recipients are prohibited." Thus, in addition to the required 20-30 ml transfused, the remaining volume of erythrocyte-containing components contained in the container is disposed of.

The collected blood and/or its components are used inefficiently – the remaining contents of the 300 ml container are disposed of – which significantly increases the cost of treatment, while there is no possibility of precise and reproducible dosing, leading, among other things, to post-transfusion reactions or complications, such as overload of the cardiovascular system, or the use of a smaller/larger than necessary amount of the donor blood component.

However, it is worth noting that according to GOST R 52938-2008 (Donor blood and its components. Containers with preserved blood or its components. Marking), it is permissible to assign “a unique number to this unit of production from among all units of production received as a result of this donation.”

Thus, when using the claimed utility model, the contents of one container obtained as a result of donation can be divided into several containers, each of which will have its own unique number, which cannot be regarded as “transfusion from one container to several recipients”.

The above-mentioned features of the procedures for dosing the obtained products (liquids, cell suspensions), which are not automated, determine the relevance of optimizing these procedures. The solution may be the developed model of the Clamp with the ability to attach to any part of the Tube, as well as its multiple use without the use of additional expensive equipment due to the detachable design, which allows for the dosing of liquids, including cell suspensions, for the purpose of their further storage and use (in particular, for therapeutic purposes), which increases the convenience and safety of their storage and use.

3. TCRab depletion procedure on the CliniMACS Plus separator.

This procedure is used for depletion of donor lymphocyte fractions in the preparation of hematopoietic stem cells obtained from a partially compatible donor for transplantation. Such a procedure is used in the absence of a fully compatible (HLA-identical) donor and the need to perform transplantation in a limited (short) time.

The Depletion Tubing Set (art. 261-01) used for the TCRab depletion procedure on the CliniMACS Plus separator is missing a clamp on the line leading to the container for non-target cells. The device itself also does not have a corresponding valve, which makes it impossible to carry out the procedure normally.

Taking into account the above-described feature of the TCRab-depletion procedure on the CliniMACS Plus separator, a possible solution may be the developed model of the Clamp with the ability to attach to any part of the Tube, as well as its multiple use without the use of additional expensive equipment due to the detachable design, which allows for the normal procedure.

The design of known non-detachable Clamps, which have holes and internal elements that allow for the closure of the lumen of the Tube, does not imply its disconnection, movement or repeated use without damaging the Tube on which it is attached. Such clamps are attached either at the factory (during the production of tubes), which limits the functionality of this type of product in terms of the choice of attachment location and multiple uses, or after disconnection and reconnection of tubes, which increases the risk of damage to the Tube, including irreversible damage, and requires stopping the procedure where this Tube is used.

Thus, the following technical problems exist:

1. The lack of a reliable and convenient mechanism for temporary clamping of the tube leads to inaccuracies in the dosing of liquids.

2. Current clamping devices can damage the tubes by deforming them or compromising their integrity, which reduces service life and increases the risk of leakage.

3. Most existing solutions require the use of additional devices or complex manipulations, which increases operating costs and complicates the work of personnel.

4. The clamps are often limited to certain areas on the tube, which reduces their versatility and ease of use.

5. High probability of errors on the part of personnel when dosing liquids due to the difficulty of controlling the degree of tube compression.

These challenges require the development of an improved clamp with increased functionality, providing reliable, adjustable and safe tube closure, with the possibility of repeated use without compromising their integrity.

The developed Clamp of increased functionality is intended to ensure the closure of the lumen of the Tube to control the flow of liquids into the container or Tube, and the design of the Clamp is distinguished by the presence of slots on one side, which allows it to be fixed in the required place of the Tube (outside the conditions of the Tube manufacturer), without damaging it and without the use of special equipment for sterile separation and connection of tubes.

The claimed product can be disconnected, moved or reused without damaging the Tube on which it is secured, including during use of the Tube without stopping the process in which this Tube is used. The two locks provided by the design on the side of the device allow for uniform compression of the tubes, eliminating their damage and reducing the efficiency of the Clamp used.

The Clamp shape is a clamp model, the outer contour of which protrudes along one side of the Clamp plane to such a height that after closing the locks, the upper plane of the Clamp will be parallel to the lower one. The inner contour of the product is oval, smoothly turning into a surface intended for clamping the Tube and having the shape of a triangle. In the end parts of the device, along the side, there are two zigzag locks with hooks (zigzag locks). The zigzag shape of the locks, in turn, improves the functionality of the device by ensuring careful opening/closing without interrupting the procedure and violating the integrity of the tube, while eliminating excessive compression or damage to the tube. On both ends (in the center of the end) there are holes for placing the Tube. In the inner contour of the product, surfaces are formed for clamping the Tube. The device includes channels for passing the Tube.

The structural elements allow for increased functionality of the Clamp by ensuring that the lumen of the Tube is closed without damaging it and at any time during the procedure where this Tube is used, including without the need to interrupt the procedure.

The essence of the proposed utility model is explained using graphic materials (implementation options).

Fig. 1 and Fig. 2 – Clamp with zigzag locks, where:

A - side,

B - side,

1 - protruding side,

2 – parallel side,

3 - zigzag lock,

4 – hole for placing the tube,

5 – surface for clamping the tube,

6 – channel for passing the tube,

7 – lock catch.

The essence of the utility model is a new approach to ensure the closure of the lumen of the Tube and is distinguished by the presence of zigzag locks on one side from the front and rear ends, which allow it to be fixed in the required place of the Tube without damaging it outside the conditions of the Tube manufacturer and without the use of special equipment for sterile disconnection and connection of Tubes. The claimed device can be disconnected, moved or repeatedly used without damaging the Tube on which it is fixed, including during the use of the Tube without stopping the process in which this Tube is used. Two locks on the side of the product provided by the design allow for uniform compression of the Tubes in the required place, excluding their damage.

The essence of the utility model is explained by examples of use, which do not limit the scope of legal protection.

Example 1. Stages and sequence of actions when using the Clamp.

The method of using the developed Clamp includes the following steps:

1. Select the section of the Tube whose lumen needs to be blocked.

2. Split the zigzag locks located on the front and back end parts of side A or B to form a gap for passing the Tube through the hole for its placement.

3. Place the Tube in the Tube placement holes so that a section of the Tube passes through the channel for its passage.

4. Close the locks.

5. At the right moment, close the lumen of the Tube by closing the Clamp by pressing on the upper part of the Clamp from the front end, at the upper part of which there is a tongue.

6. At the right moment, open the Clamp.

7. To reuse the Clamp, open the zigzag locks and remove the Clamp from the Tube and attach it to another Tube/another section of the Tube.

This ensures increased functionality by closing the lumen of the Tube in the required place of the Tube without damaging it using a Clamp attached to it outside the conditions of the Tube manufacturer and without the use of special equipment for sterile separation and connection of tubes.

Example 2. Application to the method of cryopreservation of mononuclear cells.

When using a multi-chamber container for dosing a cell suspension of mononuclear cells obtained as a result of extracorporeal photopheresis, a single-chamber container with mononuclear cells in it, in which they were irradiated, is used as a source container. A clamp is required to close the lumen of the Tube. In the standard version of the containers, a clamp between them is not provided.

The use is carried out as described in the above Method of using the developed Clamp.

This ensures uniform, reproducible dosing of the cell suspension for the purpose of its further storage (including cryopreservation) and dosed use, including after defrosting. This method increases the availability of using the mononuclear cell suspension (initial division into doses allows the use of cells throughout the entire course of treatment; the use of cell cryopreservation allows the cells to be transported to a medical facility at the patient's place of residence). The ability to transport cells with the possibility of their further clinical use in any medical organization is extremely important due to the limited number of medical organizations (in accordance with the order of the Ministry of Health of Russia No. 738n, RAS No. 3 dated November 10, 2022 "On approval of the list of medical organizations that collect, procure and transplant human organs and (or) tissues", the number of organizations that collect and procure human tissues is limited and the designated institutions are distributed unevenly across the territory of the Russian Federation, and are not represented in a number of constituent entities of the Russian Federation).

Claims (1)

A clamp for a rubber tube, including a housing and a channel for passing a rubber tube, wherein on the side on the end parts of the housing there are two zigzag locks, made with the possibility of opening with the formation of a slit for passing the tube into the opening for its placement, and in the center on the end sides of the housing - openings for placing the tube, wherein the outer contour of the housing protrudes along one of the sides of the plane to such a height that after closing the locks the upper plane will be parallel to the lower one, and the inner contour of the housing has an oval shape, smoothly turning into a surface made for clamping the rubber tube and having the shape of a triangle.