RU211369U1 - DEVICE FOR INSTALLING MEMBRANE-APPLICATOR ON LIQUID CONTAINER OF ACOUSTIC UNIT OF COMPREHENSIVE DIAGNOSIS AND HIFU-THERAPY - Google Patents

Abstract

The utility model relates to the field of medical technology designed for non-invasive energy impact on anatomical structures, in the broadest sense of this definition, by using HIFU technology. The essence of the utility model lies in the fact that the device for installing the applicator membrane on the liquid container of the acoustic unit for complex diagnostics and HIFU therapy contains a rod consisting of two parts - a conical part designed to accommodate an elastic shell with a hemisphere-shaped end , and a cylindrical part, having a diameter equal to the diameter of the container opening, and bearing two coaxially mounted bushings, the first of which is mounted for movement relative to the rod, and the second - relative to the first bushing, while the diameter of the first bushing is equal to the outer diameter of the container shoulder. The cylindrical part of the rod and the first bushing are connected to each other by means of a threaded connection, and the connection between both bushings is made in a sliding fit. The technical result of the utility model is that the device makes it possible to mount an elastic shell on an autonomous container of the acoustic unit, ensuring that the latter excludes air bubbles from entering the contact liquid in the container and significantly reduces the effect of the gel on the intensity of acoustic radiation, generally increasing the positioning accuracy of the focal area. 3 ill.

Description

The utility model relates to the field of medical technology designed for non-invasive energy impact on anatomical structures, in the broadest sense of this definition, by using HIFU technology.

The desire to use non-invasive methods of treatment has led to the discovery of the wide possibilities of high-intensity focused ultrasound in clinical and experimental medicine. Among these possibilities are neurosurgery when exposed through an unopened skull, oncology, including when exposed to tissues through the chest, tumor hypothermia, sensitization and sonodynamic therapy of tumors, treatment of prostate tumors, stopping bleeding, affecting blood vessels and blood clots, increasing the efficiency of drug transport. substances under the action of ultrasound, reversible changes in the nervous structures under the action of ultrasound, irritation of the nerve structures. This also includes the use of focused ultrasound in areas such as ophthalmology, cardiology, uterine fibroid surgery, liposuction, effects on bones, vertebral discs, etc.

All of these applications are associated with the possibility of creating local destruction in the given deep structures of the body, not accompanied by damage to surrounding tissues. The mechanism of these destructions is most often associated with the thermal action of ultrasound. If the ultrasound energy in the focal region is high enough, then the temperature at the focus can quickly increase by 20 degrees or more. If such an increase in temperature is maintained for several seconds, then the thermal dose may be sufficient to lead to the destruction of cells and tissues. It is also possible destruction created using the cavitation mechanism of action accompanying ultrasonic exposure [Gavrilov L.R. Focused high intensity ultrasound in medicine. Moscow. PHASIS. 2013. p. 309].

Known design of the device for providing acoustic contact of the HIFU emitter with the object of ablation (RU 2086178). It includes a container made in the form of a cone-shaped container intended for degassed liquid, the larger base of which is covered with a spherical emitter of a HIFU acoustic unit that combines diagnostic and therapeutic functions, and the smaller base is covered with a flexible applicator membrane.

Pointing the focal area to the ablation (coagulation) zone is carried out by moving the container, and hence the HIFU emitter associated with it. Considering that the ablation zone is a certain volume, and the focal region is a volume at least an order of magnitude less than the zone, then the focal region must move in space along three coordinates, tracked on the monitor of the diagnostic tool. Thus, the guidance process occurs by manipulating the container, which constantly rests on the surface of the object by means of a conditional "floating hinge" formed by the combination and joint deformation of the flexible applicator membrane and the contact liquid filling the cup cavity, as well as the presence at the point of contact between the applicator membrane and surface of the ablation object of a lubricating gel, which is applied to reduce friction and facilitate the movement of the acoustic unit over the ablation object. The gel facilitates the passage of ultrasound through the applicator membrane to the object, but has the ability to form a “wave” in the direction of movement in the process of moving along the surface of the latter, thus changing the thickness of the gel lubricant, which affects the accuracy of positioning the focus of ultrasonic waves generated by the HIFU emitter in direction of its decline.

In addition, as the practice of pilot operation of the acoustic unit has shown, the process of preparing the latter for operation is problematic, in particular, pouring degassed water into a container and then installing the applicator membrane on the smaller base of this cone-shaped container. The bottom line is that the end of the base of the tank must be set in a strictly horizontal position, and the surface of the poured water must coincide with the horizontal plane of the end surface. Failure to comply with this condition, i.e. the slightest misalignment leads to the fact that under the installed membrane-applicator there may be tiny air bubbles, which are resistance to ultrasonic radiation, affecting the positioning accuracy of the focal area. In general, the foregoing gives grounds to consider the flexible membrane applicator as a factor influencing the accuracy of positioning the focal area in the direction of its reduction.

A technical solution that eliminates the disadvantages of the analogue (RU 178474) and is taken as a prototype. According to the utility model, a device for non-invasive energy impact on anatomical structures contains a container made in the form of an elastic shell (bubble) filled with a contact liquid, in addition, an acoustic unit is placed in the shell. The latter includes a coaxially mounted echosonde and a spherical emitter fixed at the end of the body carrying a disc-shaped flange, to the cylindrical surface of the end of which the neck of the elastic shell of the container adjoins. The fastening of the shell and sealing of its cavity is achieved by using a band clamp. The part of the housing located outside the cavity of the shell is provided with a handle for manual manipulation of the acoustic unit in diagnostic or therapeutic processes. The shell, which acts as an applicator membrane, can be replaceable and have a different volume depending on the shape and size of the anatomical object.

Use the device as follows.

A shell filled with a contact liquid and with an acoustic block placed in it is applied to a biological object subjected to ultrasound diagnostics and therapy, having previously applied a contact liquid in the form of a thin gel layer to it (object). Since biological objects are different in shape and size, and the procedure for ultrasound exposure is the same for all of them, an explanation of the use of the device is given on a biological object, which is a female breast affected, for example, by breast cancer. When placed on the chest of the shell, it covers it from all sides. The movement of the acoustic unit during the treatment and diagnostic procedure is carried out manually or with the help of a robot, while the shell remains motionless. When the acoustic unit moves, the upper part of the shell associated with the flange moves. Depending on the capacity of the shell, its position on the chest will remain unchanged, and only its peripheral parts will move, while not sliding, but rolling. It should be especially noted that the applied thin layer applied to the ablated object under the elastic sheath retains its thickness unchanged.

The fact that with any movement of the acoustic unit, the position of the shell on the ablation object remains unchanged, the disadvantages of the analogue are eliminated, namely: the “wave” from the movement of the gel under the membrane application, which is the elastic shell, is eliminated, and the influence of the rather complicated installation of the flexible membrane-application is also eliminated. on the container for the possibility of air bubbles in the couplant. In other words, the advantages of using an elastic shell over a flexible membrane application in an acoustic unit are obvious.

The disadvantage of the prototype is that its design is designed for the use of ultrasound diagnostic technology and HIFU technology on biological objects of significant size, requiring the use of elastic shells that are also significant in size and volume, allowing to place entire acoustic blocks in the latter.

Thus, the objective of the utility model is to create a device that allows the use of an elastic shell as a membrane applicator on an acoustic unit with an autonomous container for contact fluid and mount it on it, using its advantages over a flexible membrane applicator.

The problem is solved due to the fact that the device for installing the applicator membrane on the liquid container of the acoustic unit for complex diagnostics and HIFU therapy contains a rod consisting of two parts - a conical part designed to accommodate an elastic shell with an end in the form of a hemisphere , and a cylindrical part, having a diameter equal to the diameter of the container opening, and bearing two coaxially mounted bushings, the first of which is mounted for movement relative to the rod, and the second - relative to the first bushing, while the diameter of the first bushing is equal to the outer diameter of the container shoulder.

The technical result of the utility model is that the device makes it possible to mount an elastic shell on an autonomous container of an acoustic unit, ensuring that the latter excludes air bubbles from entering the contact liquid in the container and significantly reduces the effect of the gel on the intensity of acoustic radiation, in general, increasing the positioning accuracy of the focal area .

In the drawings attached to the description of the utility model, given

in fig. 1 - section of the general view of the device along the vertical axis;

in fig. 2 and 3 are schematic representations of the device to explain its operation.

The device for installing the membrane-applicator contains a rod 1, which consists of two parts. The lower part is made in the form of a cone 2 with a rounded end, which is designed to accommodate the elastic shell 3, equipped with a mounting rubber ring "A". The cylindrical part 4 adjoining the cone 2 bears the handle 5 at its end and has a diameter equal to the inner diameter of the opening of the container 6 with a minus deviation of not more than 0.5 mm. Two coaxially arranged bushings 7 and 8 are installed on the cylindrical part 4 of the rod. The bushing 7 is mounted on the cylindrical part 4 of the rod 1 with the possibility of moving along the latter and is connected to it by means of a threaded connection 9. The bushing 8 mounted on the bushing 7 is mounted on it along a sliding landing. Container 6 (like any acoustic unit) has collar 10 intended for mounting the applicator membrane, regardless of its design, in the form of a disk, the diameter of which is equal to the outer diameter of sleeve 7. To facilitate the movement of sleeve 8, corrugation 11 is made on its surface. explanations of how to use the device in the drawings (Fig. 2 and 3) introduced, in particular, the object of ablation 17, the acoustic unit 12, the spherical emitter 13, the echo probe 14, the liquid nipple 15, the focal region 16 and the elastic shell 3a and 3b, fixed in various positions.

Device usage

Acoustic block 12 is installed and fixed in any device that allows such an opportunity, and in such a way that the opening of the container 6 faces the operator. After that, the rod 1 is adjusted for further work, for which the sleeve 7 along the thread 9 is shifted all the way into the cone 2. Next, the sleeve 8 is moved along the sleeve 7, while at such a distance between the ends of these sleeves that a step is formed, the platform of which is on the sleeve 8 approximately equal to the diameter of the elastic band "A" of the fastening of the elastic shell 3. Then, with a slight interference, the latter is put on the cone 2 of the rod 1, and the bundle "A" is placed on the previously formed area of the sleeve 7. After completing the above manipulations, the operator fills in the contact liquid, or rather degassed water into container 6, filling it up to the end surface of collar 10, and introduces cone 2 into it until the surfaces of the ends of collar 10 and sleeve 7 come into contact. In the process of immersing cone 2, water is partially displaced and poured out of container 6, taking bubbles with it air that could accumulate at the surface of the water due to the case of a slight underfilling of water in the container, which is acceptable. After installing the sleeve 7 on the shoulder 10, the operator moves the sleeve 8 along the sleeve 7 in the direction of the container 6, thus shifting the harness "A". The movement of the sleeve 8 continues until the harness "A" is under the shoulder 10 of the container 6. At this point, the process of installing the elastic membrane 3 is completed, and the rod 1 is removed by the handle 5. The elastic shell 3 is held in the container 6 in a crumpled (shrunken) state due to the surface forces of water. The operator through the nipple 15 introduces an additional portion of water into the container 6, which inflates the elastic shell to form 3a (Fig. 2). After that, the acoustic block is turned over and installed with the end of the shoulder 10 on the ablation object 17, so that the elastic shell, when interacting with the object 17, acquires the shape of a torus 3b with the optional requirement of the correctness of its shape in the form of a donut. As experience has shown, such manipulation is not difficult. When the spherical emitter 13 and the echo probe 14 are turned on, the operator can move the focal area 16 along the ablation target, for example, tumors of various etiologies by sliding the surface of the shoulder 10 along the inner surface of the elastic shell 3.

Preliminarily, without fail, the installation site of the acoustic unit is covered with a thin and uniform layer of gel, and with the inclusion of a spherical emitter, the focal area has the ability to move with three degrees of freedom and rotation, and sliding along the inner side of the shell 3 (Fig. 3) of the end of the shoulder 10 will take place under conditions where the lubricant is water, which is accompanied by a friction force much lower compared to the friction force connecting the outer surface of the shell 3 with the surface of the ablation object 17, between which a thin layer of gel plays the role of glue that does not deform during the movement of the end and is not collected in a "wave", which improves the positioning accuracy of the focal area in the ablation object.

Claims (2)

1. A device for installing the applicator membrane on the liquid container of the acoustic block of complex diagnostics and HIFU therapy, containing a rod consisting of two parts - a conical part having a rounded end and designed to accommodate an elastic shell, and a cylindrical part having a diameter equal to diameter of the container opening, and bearing two coaxially mounted bushings, the first of which is mounted for movement relative to the rod, and the second - relative to the first bushing, while the diameter of the first bushing is equal to the outer diameter of the container collar. 2. The device according to claim 1, characterized in that the cylindrical part of the rod and the first sleeve are connected to each other by means of a threaded connection, and the connection between both sleeves is made in a sliding fit.

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