RU2850607C1 - Device for ultrasonic sealing of medical pipes - Google Patents

Abstract

FIELD: sealing.

SUBSTANCE: invention relates to devices for ultrasonic sealing of medical lines of plastic blood containers and can be used to create the material and technical base of blood transfusion stations and departments. The support plate of the device is made in the form of a hollow cylinder of a pressure cap-fixer of the line with an internal blind hole and a diameter exceeding the size of the working end of the ultrasonic source. On the inner end surface of the cylinder there is a rectangular platform with a protrusion in the form of a pointed cone, the height of which does not exceed the thickness of the wall of the sealed medical line. The hollow cylinder of the pressure cap-fastener has a groove with a width equal to the diameter of the sealed medical line, with a depth from the centre to the end of the internal opening, diverging at an angle of 120 degrees to the surface of the outer diameter of the support plate. A line fastener is located on the surface of the support plate, made in the form of a blind hollow cylinder with an inner diameter exceeding the outer diameter of the support plate. The main line fastener has a groove whose depth corresponds to the depth of the groove in the support plate. The width of the groove at its end corresponds to two diameters of the sealed medical main line. The main line fastener is designed to be movable along the support plate. The movement of the fastener is limited on one side by its attachment to the device connection unit and on the other side by a compressed spring located between the outer end surface of the support plate and the inner end surface of the main line fastener. The grooves in the support plate and the line fastener are designed so that they coincide when the spring is fully compressed and fix the line with tension during the return movement of the fastener.

EFFECT: increased reliability and sealing quality.

1 cl, 3 dwg

Description

The invention relates to the field of medical technology related to the processing of donor blood, namely, to devices for ultrasonic sealing of medical lines of plastic blood containers used for collecting, storing and processing blood and its components, and can be used to create a modern material and technical base for blood transfusion stations and departments.

One of the main problems in the logistical support of the technology for collecting, processing and storing blood products is the problem of reliably sealing plastic containers during the processing of blood and its components, with the subsequent separation of the unused system of supply polymer lines and used polymer containers.

To solve this problem, plastic blood container sealing devices are used. These devices utilize mechanical clamping, heat sealing, and mechanical separation of the polymer supply lines in close proximity (no more than 10 mm) to their entry into the container. Practical blood processing technologies require repeated and lengthy sealing of blood containers and subsequent separation of unused lines and containers (some or all) directly during the process cycle in dedicated units, i.e., without transporting them to the location of permanent sealing devices.

In this regard, there arose a need to use devices for repeated and long-term sealing of plastic containers as part of special installations during the processing of blood and its components, with subsequent separation of the unused system of supply polymer lines and used polymer containers, i.e., in the creation and use of devices capable of ensuring sealing during the technological cycle of blood collection and processing.

Similar units have been developed and are widely used in transfusiology. An example of a specialized unit manufactured in the Russian Federation (OOO PROFIT PHARM) is the Automatic Blood Component Extractor model MM8 0501, RDGS.02.177.00.00.00.00.00, according to TU 32.50.50-011-18833344-2021 [1], manufactured under Russian Patent No. 2 791387 [2], designed for the automated extraction of various blood components in a polymer container system after primary and secondary centrifugation for their subsequent storage.

Structurally, the automatic extractor consists of a base unit on which the following are installed:

- touch screen that provides process control and displays the current status:

- a pressing device (press) that creates pressure on containers with centrifuged blood components;

- optical pairs (diode-optical sensor) that allow measuring the optical density of the solution flowing through the tubes;

- devices for ultrasonic sealing of medical lines of plastic blood containers, ensuring the shut-off of the flow of liquid in the lines and the subsequent separation of the lines from the containers;

The automated extractor handles disposable blood containers for collecting and storing blood components. The extractor separates the blood components. Under optical control, the blood components are collected into separate containers. The primary blood container retains the red blood cell mass with the preservative solution.

The automatic extractor operates as follows. Before the extraction procedure, the main container containing blood is centrifuged. The main container, containing the three components of blood (plasma, leukocytes with platelets, and erythrocytes), is placed on the main container pins. The container with the preservative solution is placed on the solution pins. The common line is installed in a red blood cell detection sensor and a common line sealing device, as well as a coagulant detection sensor. The plasma line is installed in a plasma line sensor and another plasma line sealing device. The leukocyte line is installed in a leukocyte line sensor and a leukocyte line sealing device on the top panel of the device. The preservative solution line is installed in a preservative solution line sealing device.

The extraction process occurs through the application of pressure from the press on the main container. The press stops when the plasma and leukocytes are separated into separate containers. After the blood components are separated, the process of adding the preservative solution to the main container begins, using the press to apply pressure to the container containing the preservative solution.

Thus, the distribution of blood fractions occurs through the action of the press and the alternating operation of the sealing devices on the medical lines of the plastic blood containers. After the procedure is complete, a sealing seam is formed 10 cm from the container on all lines, and the lines and containers containing blood products (finished product containers) are separated.

To seal the medical lines of plastic blood containers during the blood processing (separation), and to subsequently form a sealing seam at a distance of 10 cm from the container and to separate the lines and containers with blood products (containers of the finished product), ultrasonic sealing devices for medical lines of plastic blood containers are used [3, 4], the most famous of which is the device according to patent No. 2776 569, adopted as a prototype.

A device for ultrasonic sealing of medical lines includes a source of ultrasonic action on a polymer line of a blood container with a flat working end of a rectangular shape, placed in a housing, a welding support bar and a mechanism for compressing the polymer line between the working end of the ultrasonic source and the support bar.

In a known device for ultrasonic sealing of medical lines, the ultrasonic source is a half-wave piezoelectric system with a working end having a rectangular emitting surface. It is housed in a cylindrical housing and is movable within the main body. To ensure movement, the housing containing the ultrasonic source is mechanically connected to an electromechanical device (electromagnet), which drives the ultrasonic source toward a support bar. The support bar is mechanically connected to the main body and has a rectangular clamping surface larger than the emitting surface of the oscillating system. A projection is provided on the clamping surface to improve the sealing quality of the lines during blood processing and subsequent ultrasonic welding, separating the lines and containers.

A dedicated power source is used to power the magnets, and an ultrasonic generator of electrical oscillations is used to power the ultrasonic oscillator system. This generator converts electrical energy into mechanical vibration energy at an ultrasonic frequency (44 kHz). During blood processing, the blood lines are compressed using an electromechanical device. The ultrasonic generator is activated after blood processing is complete, without interrupting the compression of the polymer line between the working end and the support bar (welding support). The generator then automatically detects the completion of the weld formation, ceasing the ultrasonic action, and after the weld has cooled, it returns the ultrasonic source to its original position.

The ultrasonic sealing device for medical lines operates as follows.

During sealing, the blood container line is placed between the pressure surface of the welding support bar, which contains a protrusion, and the welding end of the oscillating system. The protrusion reduces the compression force, which ensures the line is sealed and improves the sealing quality during blood processing. Using the prototype device, sealing is ensured and ultrasonic welding is implemented, enabling high-quality sealing by forming a wide sealing seam, followed by a seam formation to separate the sealing seam and, consequently, the polymer line into two sealed sections.

Thus, the device adopted as a prototype allows for the line to be kept in a compressed state for a long time (several minutes), ensuring the sealing of the line of the required blood container and, within a few seconds (from 1 to 3, depending on the material and diameter of the line), forming a sealing seam up to 4 mm wide in the immediate vicinity of the tube insertion into the blood container (10 mm), with an electrical power consumption of less than 50 W and the elimination of high-frequency interference.

Separation of the unused line system from the blood containers is accomplished by creating a sealing seam through a cut. The cut is made with a special plate secured to the surface of the pressure bar. Thus, after separation, both the blood container and the removed systems remain hermetically sealed.

However, the prototype has the following disadvantages:

1. The lines are placed in the device manually. The lines are not secured between the working end and the support (pressure) bar during placement. During blood processing, sealing, and periods of absence of the force required to ensure a seal, mechanical movement of the lines is possible, i.e., changes in their position relative to the working end and the support (pressure) bar.

The lack of fixation and the potential for line movement can lead to disruption of the blood processing process, i.e., spoilage of the final product due to a leaky seal on a particular line during processing, or spoilage of the final product due to a poor seal on the separated container. A breach in the seal of containers or lines separated by ultrasonic welding poses a risk of product loss and exposure to the operator and extractor.

2. Compressing the welded tube between the working end and the support (pressure) bar allows for ultrasonic action and the formation of a seal only if the lines are optimally positioned relative to the working end and the support bar, i.e., if the lines are positioned without any distortion or displacement relative to the radiating surface of the working end. Only then will the lines be fully compressed to the required level. Otherwise, the quality of the weld formed using a prototype will be insufficient to ensure the required quality of the final product.

3. Compression is applied from the side of the line in contact with the ultrasonic source (as it moves relative to the fixed bar). In this case, the compression occurs in the absence (or insufficient) of contact between the support pad and the tube. If such contact occurs through the cutting flat projection on the bar, the wall of the line will burn through after an indefinite period of time due to the absorption of vibrations. The prototype does not provide for simultaneous and uniform compression on both sides of the line, since the pressure bar is mechanically connected to the housing. A projection in the form of a special plate fixed to the surface of the pressure bar is made on the bar's surface, which does not allow for uniform compression of the line to the required value. Furthermore, making a cut with a special plate fixed to the surface of the pressure bar results in a preliminary uneven mechanical impact (before welding) on the line, which may lead to mechanical damage to the line during blood processing and a loss of the line's seal even before ultrasonic welding or with the onset of ultrasonic exposure.

4. The creation of a projection on the surface of the bar in the form of a special plate with a flat surface, fixed to the surface of the pressure bar, ensures that in the initial period only the flat contact surface of this plate is pressed, and then with the formation of a rectangular depression, which does not allow for uniform compression of the line to the required value.

Thus, the device for ultrasonic sealing of medical lines of plastic blood containers, adopted as a prototype, is not suitable for use in automatic blood component extractors (Devices for extracting blood components from centrifuged whole blood), because does not provide long-term, reliable sealing during blood processing and does not ensure the fixation of the line relative to the emitter, i.e. the required quality of sealing when separating used lines and containers.

The proposed device addresses the shortcomings of the existing device, designed for ultrasonic sealing of medical lines of plastic blood containers, and creates a compact device for completing blood processing units and obtaining new blood products, ensuring reliable sealing both during blood processing and ultrasonic welding for separating containers and preserving the final product.

The technical result of the invention is expressed in increasing the reliability and quality of sealing due to fixation, during the blood processing, of the lines between the working end and the support (pressure) bar, eliminating possible mechanical movements of the lines, i.e. changes in its position relative to the working end and the support (pressure) bar, in implementing an ultrasonic effect and forming a sealing seam with an optimal placement of the lines relative to the working end and the support bar, with the implementation of compression during the sealing process simultaneously and evenly on both sides of the line for uniform compression of the line to the required size, and also due to the formation of a protrusion of a special shape and height on the surface of the bar.

The essence of the proposed technical solution is that in the known device for ultrasonic sealing of medical lines, including a source of ultrasonic action on the polymer line of the blood container, located in the housing, having a flat working end of a rectangular shape, a welding support bar and a mechanism for compressing the polymer line between the working end of the source of ultrasonic action and the support bar, the support bar is made in the form of a hollow cylinder of a push-on cap-fixator of the line, with an internal blind hole, the diameter of which exceeds the size of the working end of the source of ultrasonic action, is mechanically connected to the housing, on the inner end surface of the cylinder there is a platform of a rectangular shape, on the surface of which a protrusion is made in the form of a pointed cone, the height of which is not more than the thickness of the wall of the medical line being sealed, the hollow cylinder of the push-on cap-fixator has a groove, the width of which is equal to the diameter of the medical line being sealed, the depth, in the center to the end of the internal hole and diverging at an angle of 120 degrees to the surface of the outer diameter of the support a line retainer is placed on the surface of the support bar, made in the form of a blind hollow cylinder with an internal diameter exceeding the external diameter of the cap - retainer, a groove is made in the line retainer, the depth of which corresponds to the depth of the groove in the support bar, the width of the groove at the place of its end corresponds to two diameters of the sealed medical line, the line retainer is designed with the possibility of movement along the support bar, limited, on the one hand, by its fastening in the connection unit of the device, and on the other hand, by a compressed spring placed between the outer end surface and the inner end surface of the line retainer, wherein the grooves in the support bar and the line retainer are made in such a way that they coincide when the spring is fully compressed and fix the line with tension during the return movement of the retainer.

The essence of the proposed technical solution is explained in Fig. 1, which schematically shows the design diagram of the device for ultrasonic sealing of medical lines.

In Fig. 1 the following designations are adopted: 1 - ultrasonic exposure source - ultrasonic oscillating system; 2 - ultrasonic exposure source housing; 3 - rectangular welding support platform; 4 - flange; 5 - electromagnet; 6 - device housing; 7 - stop screw; 8 - guide rod; 9 - hollow cylinder of the push-button cap-line retainer; 10 - line retainer nut; 11 - electromagnet washer; 12 - tube retainer spring; 13 - ultrasonic oscillating system housing spring; 14 - optical sensor board; 15 - spring of the optical sensor rod; 16 - optical sensor rod; 17 - medical line

Ultrasonic source 1, as in the prototype, is implemented as a half-wave piezoelectric oscillator system. The source has a flat, rectangular radiating surface and is housed in a separate, movable cylindrical housing 2, allowing it to move within an outer housing 6.

The support bar is made in the form of a hollow cylinder of the push-button locking cap 9, on the inner end surface of which a rectangular welding support pad 3 is located. The support bar, made in the form of a hollow cylinder of the push-button locking cap 9, has an internal blind hole with a diameter exceeding the size of the working end of the ultrasonic exposure source and is mechanically connected to the housing 6. A projection in the form of a pointed cone is made on the rectangular welding support pad 3. This shape of the projection ensures a reduction in the compression force when sealing the lines 17 (a decrease in the contact area during compression) during blood processing, and the implementation of this cone with a height no greater than the wall thickness of the sealed medical line 17 ensures not only high-quality sealing, but also the implementation of ultrasonic welding with separation of the sealed lines 17 and containers without the application of mechanical force or special devices (scissors).

The possibility of moving the hollow cylinder of the pressure cap-clamp 9, relative to the welding support platform of rectangular shape 3, with a projection formed on it in the form of a pointed cone, i.e. relative to the main line 17 and the nut of the main line clamp 10, ensures the simultaneous compression of the main line 17 both by the ultrasonic radiation source 1 moved under the action of the electromagnet 5, and by the pressure cap-clamp 9, which is spring-loaded relative to the welding support platform of rectangular shape 3.

The possibility of moving the hollow cylinder of the pressure cap-lock 9 relative to the line 17 and the line lock nut 10 ensures the fixation of the line 17 relative to the ultrasonic radiation source 1, as well as relative to the rectangular welding support platform 3 and the projection made on it in the form of a pointed cone.

In the hollow cylinder of the push-button cap-retainer 5 there is a groove, the width of which is equal to the diameter of the medical line being sealed (5 mm), the depth, in the center up to the end of the internal hole and diverging at an angle of 120 degrees to the surface of the outer diameter of the support bar 4, i.e. in the line retainer there is a groove, the depth of which corresponds to the depth of the groove in the support bar, the width of the groove at the place of its end corresponds to two diameters of the medical line being sealed, the line retainer is designed with the possibility of movement along the support bar, limited, on the one hand, by its fastening in the device connection unit, and on the other hand, by the compressed spring 12, placed between the outer end surface of the support bar and the inner end surface of the line retainer, wherein the grooves in the support bar and the line retainer are made in such a way that they coincide when the spring is fully compressed and fix the line with tension during the return movement of the cap-retainer.

The movable body 2 with the ultrasonic source 1 is mechanically connected to the electromechanical device 5 by the return spring 13, which provides the required pressing force to the welding support bar 3.

The ultrasonic sealing device for medical lines operates as follows.

The retainer is moved (manually, providing mechanical action and movement of the retainer), in which a groove is made, the width of which is equal to the diameter of the medical line being sealed (5 mm), the depth of which is centered to the end of the internal opening, and diverging at an angle of 120 degrees to the surface of the outer diameter of the support bar 4, i.e., free access for placing the line in the groove is ensured. The line is placed in the retainer so that it is at the depth of the groove in the support bar. Since the width of the groove at its end corresponds to two diameters of the medical line being sealed, placement of the line occurs without difficulty. Since the line retainer is designed to move along the support bar, mechanical action is eliminated and return movement of the retainer is ensured by a compressed spring located between the outer end surface of the support bar and the inner end surface of the line retainer. Since the grooves in the support bar and the line retainer are designed in such a way that they coincide when the spring is fully compressed, during the return movement of the cap-retainer, the line is mechanically fixed under tension.

Since the blood container line is firmly fixed in the optimal position for compression and welding, voltage is applied to an electromagnet between the pressure surface of the welding support bar, which houses the segmenting protrusion, and the welding end of the oscillating system. This electromagnet causes the oscillating system to move within the housing and compress the line to the required level. The protrusion ensures a sealed line, and after the process of extracting the necessary blood products is completed, a weld is formed and the line is separated into two sealed units.

The use of the proposed device for ultrasonic sealing of medical lines ensures the sealing of medical lines of blood containers during blood processing and subsequent ultrasonic welding, which allows for high-quality sealing by forming a wide sealing seam, with the simultaneous formation of a cut to separate the sealing seam and, accordingly, the polymer line into two sealed sections.

An example of the placement and fixation of the line in the device for ultrasonic sealing of medical lines is shown in the photographs Fig. 2.

The proposed technical solution for ultrasonic sealing of medical lines, consisting of a set of 5 devices, a control board, and ultrasonic generators intended for practical use in industrial extractors such as the MM8 0501 model, is shown in Fig. 3. The device weighs no more than 460 grams. The oscillatory system utilizes a half-wave design. The selected design allowed for the creation of an oscillatory system with an operating frequency of 44 kHz, providing, under specified operating conditions, an oscillation amplitude of at least 25 µm at the working end of the ultrasonic generator. The power consumption of each device does not exceed 30 watts.

The conducted studies of the functional capabilities of the created device made it possible to establish that the created device for ultrasonic sealing of medical lines is suitable for use in industrial extractors of the MM8 0501 model according to RDGS.02.177.00.00.00.00.00, manufactured according to TU 32.50.50-011-18833344-2021 [1, 2], manufactured by PROFIT PHARM LLC), intended for the automated production of various blood components in a system of polymer containers after primary and secondary centrifugation for their further storage by ensuring the required reliability and quality of sealing during blood processing, achieved by forming a sealing seam with optimal placement of the lines relative to the working end and the support bar, while implementing compression during the sealing process simultaneously and evenly on both sides of the line for uniform pinching of the line to the required value.

The created device ensures line sealing in less than 1 second and welding with separation in less than 2 seconds, which allows to meet the needs of the modern blood service.

Currently, PROFIT FARM LLC is preparing for serial production of the created device.

List of references

1. Technical specifications 32.50.50-011-18833344-2021 "Automatic blood component extractor" model MM8 0501 according to RDGS.02.177.00.00.00.00.00 (manufacturer PROFIT PHARM LLC) Internet resource: https://mmcs.ru/catalog/mmcs-0501/?lang=ru

2. Device for extracting blood components from centrifuged whole blood [Text] patent for IZ RU 2 791 38; IPC A61M 1/34 (2006.01), A61M 1/38 (2006.01) / Grigoriev Lev Viktorovich (RU), Tskhe Aleksey Viktorovich (RU), Karakulov Aleksandr Sergeevich (RU): applicant and patent holder: PROFIT PHARM Limited Liability Company (RU) (RU); application 2022115005, dated 02.06.2022, published: 10.01.2006.

3. Device for ultrasonic sealing and segmentation of transfusion systems [Text] patent for IZ RU 2 267 316 C1; IPC A61J 1/05 (2006.01) / Khmelev V.N., Barsukov R.V., Tsyganok S.N., Slivin A.N., Khmelev M.V. applicant and patent holder: State Educational Institution of Higher Professional Education "Altai State Technical University named after I.I. Polzunov" (AltSTU) (RU); application No. 2004116746/14, dated 01.06.2004, published: 10.01.2006.

4. Device for ultrasonic sealing and segmentation of transfusion systems [Text] patent for IZ RU 2776 569 C1; IPC A61J 1/05 (2006.01), B65B 51/22 (2006.01) / Genne Dmitry Vladimirovich (RU), Nesterov Viktor Aleksandrovich (RU), Tertishnikov Pavel Pavlovich (RU), Khmelev Vladimir Nikolaevich (RU), applicant and patent holder: Limited Liability Company "Center for Ultrasound Technologies" (RU); application No. 2022104236, dated 17.02.2022, published: 22.07.2022. - prototype.

Claims (1)

A device for ultrasonic sealing of medical lines, including a source of ultrasonic action on the polymer line of a blood container, located in a housing, having a flat working end of a rectangular shape, a welding support bar and a mechanism for compressing the polymer line between the working end of the ultrasonic effect source and the support bar, characterized in that the support bar is made in the form of a hollow cylinder of a push-on cap-lock of the line with an internal blind hole with a diameter exceeding the size of the working end of the ultrasonic effect source, mechanically connected to the housing, on the inner end surface of the cylinder there is a rectangular platform, on the surface of which there is a protrusion in the form of a pointed cone with a height not exceeding the thickness of the wall of the medical line being sealed, the hollow cylinder of the push-on cap-lock has a groove with a width equal to the diameter of the medical line being sealed, with a depth in the center to the end of the internal hole, diverging at an angle of 120 degrees to the surface of the outer diameter of the support bar, on the surface of the support bar there is a lock The line retainer is made in the form of a blind hollow cylinder with an internal diameter exceeding the external diameter of the support bar, a groove is made in the line retainer, the depth of which corresponds to the depth of the groove in the support bar, the width of the groove at the place of its end corresponds to two diameters of the sealed medical line, the line retainer is made with the possibility of movement along the support bar, limited on one side by its fastening in the device connection unit, and on the other side by a compressed spring placed between the outer end surface of the support bar and the inner end surface of the line retainer, wherein the grooves in the support bar and the line retainer are made in such a way that they coincide when the spring is fully compressed and fix the line with tension during the return movement of the retainer.