RU2790758C1 - Device for fixing the mammary glands during examinations aimed at detecting neoplasms - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to the field of medicine and can be used in the detection of non-palpable masses using combined ultrasound and magnetic resonance navigation (Fusion), followed by a core biopsy. A device for fixing the mammary gland in the supine position when detecting non-palpable masses using combined ultrasound and magnetic resonance navigation with subsequent core-biopsy is a flat 20-25 mm thick patch made of elastic washable material, made in the form of a straight prism with rectangular bases and central cylindrical hole. The height of the hole is parallel to the height of the prism, and the diameter corresponds to that of the fixed mammary gland. Herewith, the patch has four symmetrical holes with a diameter of 10 to 12 mm to mark of the patch location on the skin and facilitate combining its location during ultrasound and magnetic resonance imaging. These holes are located on a circle with a radius of 80 mm drawn from the center of the central hole and passing through the centers of the said four holes.

EFFECT: reliable and accurate fixation of the mammary glands is achieved.

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Description

The invention relates to the field of medicine and can be used in the detection of non-palpable formations under combined ultrasound and magnetic resonance navigation (Fusion), followed by a core biopsy.

The urgency of the problem of non-palpable formations in the mammary gland accelerated the development of the technique and the disclosure of the main advantages of the combined breast biopsy under MRI and ultrasound guidance, consideration of the technical aspects of the combined ultrasound and magnetic resonance navigation.

Verification (obtaining material for performing histological and immunohistochemical studies) is an integral step in the diagnosis of malignant neoplasms of the mammary glands. The core biopsy method makes it possible to obtain a sufficient amount of material at the pre-treatment stage to determine the nature of neoplasms, determine tissue prognostic factors, hormone receptors, and other indicators in order to select the optimal treatment. In addition, it is a low-traumatic procedure, which makes it possible to avoid unnecessary surgical interventions (sectoral resection of the mammary gland with urgent histological examination) in a number of categories of patients: with somatic diseases, with severe concomitant pathology, with a multicentric form of the tumor.

There are various methods of visual control when performing a breast biopsy. In routine practice, in most cases, a biopsy of non-palpable breast lesions is performed under ultrasound guidance (Liberman L. Clinicalmanagementissues inpercutaneouscorebreastbiopsy. RadiolClinNorthAm. 2000; 38: 791-807). Ultrasound navigation provides a good visualization of the movement of the needle in the "real time" mode, and the procedure can be performed in any room (ultrasound diagnostic room, operating room, treatment room) and does not take much time.

The fusion biopsy method is a hybrid method: it allows you to combine previously obtained MRI images, which clearly show the pathological focus, and the image obtained using an ultrasound machine directly during the biopsy. The ultrasound doctor clearly sees the area of interest and accurately takes the material. This significantly increases the likelihood of the biopsy needle entering the pathological focus, and, therefore, makes it possible to establish an accurate diagnosis (NakanoS., YoshidaM., FujiiK., YorozuyaK., MouriY., KousakaJ., FukutomiT., KimuraJ., IshiguchiT., OhnoK., Mizumoto T., Harao M. FusionofMRIandsonographyimageforbreastcancerevaluationusingreal-timevirtualsonographywithmagneticnavigation:Firstexperience.JpnJClinOncol.2009;39:552-559).

A feature of image fusion (Fusion) when performing core biopsies, in contrast to the above interventional procedures, is that the mammary gland is a mobile organ, changes its shape depending on the position of the body, and is easily deformed by external influences. As a rule, MRI of the mammary glands is performed with the patient lying on her stomach, and the mammary glands themselves hang freely, are not fixed, and are not deformed. Whereas ultrasound is performed with the patient in the supine position, with her arms raised behind her head, the mammary glands are deformed, changing their shape, and can also shift to the sides. In this connection, in order to obtain accurate diagnostic data, it is necessary to ensure the fixation of the mammary glands during the examination.

A known system for immobilizing a patient in the treatment of chest tissues (US 2005085722 A1, 04/21/2005), containing a U-shaped support for the wrist with a flattened bottom and rounded tops, a second support with a U-shaped cross section, mounted on a support frame, which with rotatably attached to an inclined chest board near its edge. In the method of hybrid imaging by combining ultrasound and MRI data (US 2015305700 A1, 10/29/2015), devices such as mechanical supports, vacuum cushions, individual hard masks, materials that are fixed in electric, magnetic or electromagnetic fields, but in their absence are deformable, materials that are in a certain range of temperatures or pressures, but are not deformable. These solutions allow patients to be placed in an accurate and repeatable manner to improve diagnosis and treatment, but they do not provide fixation of the mammary glands.

There are known disposable pads for breast biopsy (https://www.newmaticmedical.com/barrier-protection/p/DisposableBreastBiopsyCovers/), which provide hygiene during the procedure, however, due to the softness and flexibility of the material from which they are made, they do not have sufficient hardness and stable shape and, accordingly, cannot perform a supporting function and provide support and fixation of breast tissues.

Known positioning of the breast for biopsy during mammography, for example, using two plates - support and compression plate (US 7974378 B2, 07/05/2011).

It is also known to perform stabilization of breast tissues using an exoskeleton in the form of a thermoplastic mesh, which softens when heated (US 5682890 A, 04.11.1997). The heat-softened material stretches and adapts to the patient's soft tissue area, such as the chest. The material is allowed or forced to solidify and is attached to the patient support such that the soft tissue is tightly constrained.

A device for breast immobilization in the form of a cup with a vacuum system (US 2008230074 A1, 09/25/2008) is known, which consists of two layers connected together with an air space between them. The inner layer has tightly perforated holes, while the outer layer is sealed. When a negative vacuum is applied to the intermediate air space, the breast tissue is sucked into the mesh wall of the inner layer to prevent slipping. In addition, the cup assembly is fixed in a predetermined position relative to the patient's torso by means of a body fixture, as well as relative to the patient's support structure.

The closest analogue of the claimed invention is a device for fixing the mammary gland with a non-invasive method for its study and / or treatment (RU 201721 U1, 12/29/2020).

However, due to the design features of the execution, the above solutions cannot provide reliable fixation of the mammary glands without excessive compression and deformation.

The technical problem solved by the present invention is to ensure an accurate initial comparison of MRI and ultrasound images due to fixation (without excessive compression and deformation) of the mammary glands in the same position, both during tomographic and sonographic examination, which allows, at the final stage, to carry out a precise localization of the tumor node in the area of the biopsy (Fusion-biopsy).

The technical result of the claimed invention is a reliable and accurate fixation of the mammary glands in the supine position when detecting non-palpable formations under combined ultrasound and magnetic resonance navigation (Fusion) followed by a core biopsy.

The technical result of the claimed invention is achieved by the fact that the device for fixing the mammary glands in one position when detecting non-palpable formations under combined ultrasound and magnetic resonance navigation with subsequent core-biopsy, according to the invention, is a flat patch made of elastic washable material, 20-25 mm thick , made in the form of a straight prism with rectangular bases and containing a central hole of a cylindrical shape, the height of which is parallel to the height of the prism, and the diameter is made in a size corresponding to the size of the fixed mammary gland, and the patch contains four symmetrical holes for skin marking the location of the patch with the possibility of combining its location when carrying out ultrasonic and magnetic resonance research, which are located on a circle with radius R drawn from the center of the central hole and passing through the centers of the four holes mentioned. In this case, the radius R is 80 mm.

In addition, polyurethane foam is used as an elastic, washable lining material.

In addition, the diameter of the central hole of the cylindrical patch is at least 100 mm.

In addition, the diameter of the central hole of the cylindrical lining is from 100 to 150 mm.

In addition, the diameter of the four symmetrical holes for skin marking the location of the lining is from 10 to 12 mm.

Thus, the use of the developed device for fixing the mammary glands in one position provides reliable fixation and control over the performance of biopsies in real time in patients with insufficient or no echographic visualization of the tumor node (for example, with its small size, "shielding" by ribs or intraparenchymal location ).

The invention is illustrated by the following drawings:

Fig. 1 - a device for fixing the mammary glands in one position when detecting non-palpable formations under combined ultrasound and magnetic resonance navigation with subsequent core-biopsy, top view.

Fig. 2 - a device for fixing the mammary glands in one position when detecting non-palpable formations under combined ultrasound and magnetic resonance navigation with subsequent core-biopsy, side view.

Fig. 3 - a device for fixing the mammary glands in one position when detecting non-palpable formations under combined ultrasound and magnetic resonance navigation, followed by a core-biopsy, an angled view.

Fig. 4 - a device for fixing the mammary glands in one position when detecting non-palpable formations under combined ultrasound and magnetic resonance navigation with subsequent core-biopsy, installed on the chest.

Fig. 5–9 – stages of combined studies.

Fig. 10-12 - clinical examples of visualization of tumor formations in the mammary gland using combined images (on the left of the screen - ultrasound images, on the right - MR tomography.

A device for fixing the mammary glands in one position when detecting non-palpable formations under combined ultrasound and magnetic resonance navigation, followed by core biopsy, is a flat patch made of elastic washable material (figure 1-figure 4). Soft polyurethane foam or other gas-filled polymeric materials (for example, foamed polypropylene) can be used as the lining material. The main requirements for the material from which the overlay can be made are as follows: environmental safety, the possibility of washing and disinfection, and elasticity. The overlay is made in the form of a straight prism with rectangular bases and contains a central hole 1 of a cylindrical shape, the height of which is parallel to the height of the prism, and the diameter (D) is made in a size corresponding to the size of the fixed mammary gland. The sizes of the central openings 1 for the mammary gland should naturally be different for different sizes of the mammary glands. In this case, the diameter (D) of the central hole 1 of the cylindrical lining is at least 100 mm, preferably from 100 to 150 mm. These sizes were selected empirically and allow placing mammary glands of various sizes in the pads without causing discomfort to the patient.

In addition, the overlay contains four symmetrical holes 2 for marking the location of the overlay on the skin with the possibility of combining its location during ultrasonic and magnetic resonance examinations, which are located on a circle with a radius R drawn from the center of the central hole and passing through the centers of the said four holes. In this case, the diameter of four symmetrical holes 2 for skin marking of the patch location is from 10 to 12 mm, and the radius R is 80 mm. This hole diameter 2 allows skin marking with most commercially available skin markers. A diameter of less than 10 mm will make such marking difficult, and an increase in diameter over 12 mm may lead to inaccurate positioning of the applied skin “marks”. The radius R = 80 mm is also selected empirically, taking into account the distance from the edge of the hole 1, and is sufficient for optimal skin marking of the position of the lining relative to the mammary gland.

The dimensions of the lining are selected empirically: in order to hold large mammary glands, but at the same time not to cause inconvenience to the patient, not to put pressure on the second gland, and, for example, they can be width a - 280 mm, length b - 360 mm, thickness h - 20 -25 mm. In MRI, the pressure of the outer coil of the MR scanner is sufficient to hold the patch. With ultrasound, the overlay is "held" by the gland itself and can be additionally fixed with an adhesive plaster.

The overlay is used as follows:

At the first stage, an MRI of the mammary glands is performed in a certain position and with a certain set of sequences (Fig. 5).

The second stage, the patient is turned over on her back, placed in the position that will be most preferable for core-biopsy under ultrasound control (Fig.6). Next, the mammary gland must be fixed in a stable but not deformed position (Fig.7). For skin marking the location of the patch on the patient's body, four small symmetrical holes 2 are used (see figure 1). After that, scanning is performed using a standard surface MR coil and obtaining a T1-weighted post-contrast sequence.

At the third stage, the patient moves to the sonography room, where she is placed in the same position in which she was on her back during the MRI (Fig. 8), and the mammary glands should again be gently fixed in the same position (Fig. 9). MR images are loaded into the ultrasound scanner, and the ultrasound doctor combines the performed MR images with the ultrasound picture in real time. Once the target is found, a core biopsy of the suspicious area is performed.

Fixation of the mammary gland at all 3 stages is carried out using the claimed device - an overlay made, for example, of polyurethane foam, with round slots of various diameters for the mammary gland itself. Depending on the size of the breast, one or more of these overlays can be used, stacked one on top of the other.

Thus, the use of the developed device for fixing the mammary glands during the examination, made in the form of a flat overlay of a given shape in combination with the material from which the device is made, makes it possible to avoid excessive squeezing and deformation of the breast tissues due to the sufficient softness of the material, for example, polyurethane foam and in at the same time, it provides accurate fixed positioning of the examined organ, performing the functions of a supporting element due to such characteristic properties of this material as elasticity and elasticity. As a result, it is possible to achieve an accurate initial comparison of MRI and ultrasound images by fixing the mammary glands in the same position, both in tomographic and ultrasound examinations, and at the final stage to conduct precise localization of the tumor node in the biopsy area.

Below are examples confirming the achievement of a technical result in the implementation of the invention.

Clinical example #1:

Patient K., 69 years old. In 2017, she complained about the presence of education in the right mammary gland. Primary ultrasound of the mammary glands revealed a tumor in the right mammary gland about 4.0 cm in diameter. Next, the patient underwent MRI of the mammary glands, first in the prone position: MRI picture of cancer of the right breast, multicentric form of growth. After that, the patient was placed in the position most suitable for further possible core biopsy under combined ultrasound and magnetic resonance navigation (Fusion): turned over on her back, turning to the left god, her right hand was raised behind her head. The right mammary gland was fixed with flat "pillows" of polyurethane foam. An MRI was again performed, after which the patient was transferred to the ultrasound room and laid in the same position in which she was during the last MRI examination: lying on her back, with a turn to the left god, her right hand was raised behind her head. The right mammary gland was fixed with flat "pillows" of polyurethane foam.

With repeated ultrasound according to the method we developed, on the basis of the previously performed MR study, Fusion-combination of MRI and ultrasound images was performed and a targeted trephine biopsy of the second described formation was performed (Fig. 10-11). Histological and IHC study of the obtained material showed the presence of invasive unspecified cancer of the right breast, grade 2; surrogate molecular type of tumor: luminal type B, Her2-negative, which fundamentally influenced the tactics of further management of the patient (carrying out chemotherapy).

Clinical example #2:

Patient Zh., 43 years old. during examination according to ultrasound, mammography in April 2021 - the picture is suspicious for cancer of the right breast. An ultrasound-guided biopsy was performed. According to the histological examination: the morphological picture is suspicious for invasive breast cancer.

Next, the patient underwent an MRI of the mammary glands, first in the prone position: the MR picture corresponds to a tumor in the upper inner quadrant of the right breast (BIRADS 6). Hypervascular formation in the lower inner square of the right breast (multifocal tumor growth?).

After that, the patient was placed in the position most suitable for further possible core biopsy under combined ultrasound and magnetic resonance navigation (Fusion): turned over on her back, her right arm raised behind her head. The right mammary gland was fixed with flat "pillows" of polyurethane foam. An MRI was again performed, after which the patient was transferred to the ultrasound room and laid in the same position in which she was during the last MRI examination: lying on her back, her right hand was raised behind her head. The right mammary gland was fixed with flat pads of polyurethane foam.

During repeated ultrasound, according to the method we developed, on the basis of the previously performed MR study, Fusion-combination of MRI and ultrasound images was performed and a second mass was detected (Fig. 12).

Claims (4)

1. A device for fixing the mammary gland in the supine position when detecting non-palpable formations under combined ultrasound and magnetic resonance navigation, followed by a core biopsy, characterized in that it is a flat pad of elastic washable material, 20-25 mm thick, made in in the form of a straight prism with rectangular bases and containing a central hole of a cylindrical shape, the height of which is parallel to the height of the prism, and the diameter is made in a size corresponding to the size of the fixed mammary gland, and the patch contains four symmetrical holes with a diameter of 10 to 12 mm for skin marking the location of the patch with the possibility of alignment its location during ultrasound and magnetic resonance imaging, which are located on a circle with a radius of 80 mm, drawn from the center of the central hole and passing through the centers of the four holes mentioned. 2. The device according to claim 1, characterized in that polyurethane foam or expanded polypropylene is used as an elastic washable lining material. 3. The device according to claim 1, characterized in that the diameter of the central hole of the cylindrical shape of the lining is at least 100 mm. 4. The device according to claim 1, characterized in that the diameter of the central hole of the cylindrical shape of the lining is from 100 mm to 150 mm.

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