RU2807378C1 - Method for mr-controlled breast biopsy - Google Patents

Abstract

FIELD: radiation diagnostics.

SUBSTANCE: used for MR-controlled breast biopsy. At least one stage of determining the location of the skin incision is first performed, which includes installing a stencil from the biopsy kit on the skin in the area of the mammary gland, inserting a guide with an MR-contrast rod into the selected hole of this stencil, bringing the rod directly to the skin pre-treated with an antiseptic, performing control abbreviated series of T1-weighted images (T1-WI). The obtained T1-WI are analyzed by drawing a virtually straight line from the end of the rod, which is a continuation of this rod. Moreover, if the drawn virtual line does not cross the expected pathological area and does not come into contact with it, the stage of determining the location of the skin incision is repeated. If the drawn virtual line crosses the suspected pathological area or comes into contact with it, then the skin is re-treated with an antiseptic, then anesthesia is administered, an incision is made in the skin treated with the antiseptic, a guide and trocar are inserted into the tissue, and then removed, and an MR contrast rod is inserted into the guide. A scan is performed and material is taken for histological examination from the suspected pathological area.

EFFECT: eliminating erroneous skin incisions by pre-determining the location of the incision.

6 cl, 7 dwg, 1 tbl, 3 ex

Description

The invention relates to the field of medicine, namely to radiation diagnostics and can be used for biopsy of breast tumors and suspicious clinically significant findings of the breast.

From RU 165261 U1, 06/10/2016 there is known a method for localizing non-palpable formations of the mammary glands and a device for its implementation, containing a guide, which is made in the form of a plate with ports, and the central port is made straight for the free passage of a fixing interstitial localizer through it, and the side ports are made with an inclination towards the center for free passage of the auxiliary search needle, which allows you to clarify the location of the pathological focus.

However, the use of an additional needle is a disadvantage of the known method, as it creates additional trauma to the tissue during the intervention.

There is a known biopsy method, including obtaining diffusion-weighted images and performing a preliminary virtual biopsy (YI YIN et al. Diffusion-weighted MRT-guided needle biopsies permit quantitative tumor heterogeneity assessment and cell load estimation. Cornell University, 03/01/2021, pp. 1- 37).

However, the situation displayed during a preliminary virtual biopsy does not always correspond with 100% accuracy to the clinical situation on the operating table; in addition, not all clinics have the appropriate equipment that allows performing a preliminary virtual biopsy.

There are also known methods for performing biopsies using stencils of various shapes, guides, needles, which allow increasing the accuracy of the manipulations (US 10357326 B1, 07/23/2019, US 8568333 B2, 10/29/2013).

As the closest to the proposed technical solution, we can take the known method of breast biopsy, carried out using the kit described in the source of information (Breast Biopsy Kit, NORAS MRI products, March 2020, pp. 1-4), including lattice stencils, localization cubes for inserting a biopsy needle into them, intended for installation in the hole of the stencil grid, a guide, an MR contrast rod, a trocar, a biopsy needle.

The presence of stencils increases the accuracy of the manipulation, however, in some cases situations nevertheless arise when, after puncture with a biopsy needle and its insertion into the breast tissue, it is not possible to reach the pathological focus, and therefore it is necessary to carry out a new, repeated puncture and repeated insertion biopsy needle in a new direction.

The technical problem to which the proposed invention is aimed is to eliminate the risk of making erroneous incisions that do not allow access to the intended pathological area.

Making an erroneous incision leads to the need for repeated incisions, which, firstly, creates additional trauma, and, secondly, in the case of malignant tumors, creates an additional risk of dissemination of tumor cells.

The technical result of the claimed invention is to ensure the elimination of erroneous incisions, since the selected direction of insertion of the biopsy needle is verified directly on the operating table, and immediately before performing the manipulation.

The claimed technical result is ensured by the fact that according to the proposed method of MP-controlled breast biopsy, at least one stage of determining the location of the skin incision is first performed, which includes installing a stencil on the skin in the area of the mammary gland, inserting a guide with an MP-contrast rod into the selected hole of the stencil , bringing the rod directly to the skin pre-treated with an antiseptic, performing a control abbreviated series of T1-weighted images (T1-WI), analyzing the resulting T1-WI with drawing a virtually straight line from the end of the rod, which is a continuation of this rod, and if the drawn virtual line is not crosses the supposed pathological area and does not come into contact with it, repeat the step of determining the location of the skin incision, and if the drawn virtual line crosses the supposed pathological area or comes into contact with it, then re-treat the skin with an antiseptic, then anesthesia is performed, an incision is made in the skin treated with an antiseptic, and injected into a tissue guide and a trocar, which is then removed, and an MP-contrast rod is inserted into the guide and a scan is performed and material for a biopsy is taken from the suspected pathological area.

In a particular case, the stencil is a lattice with a localization cube for inserting a biopsy needle through it, and the cube can be installed in any of the lattice holes.

In particular cases, the NORAS Breast Biopsy Kit is used.

In a particular case, a biopsy is performed with a 9G needle connected to a vacuum system.

In particular cases, the biopsy is performed using an automatic biopsy gun with a 14G 16 cm or 12G 16 cm needle.

In a particular case, during a biopsy, 4-6 tissue samples are taken. The invention is illustrated by illustrations.

In fig. 1-3 shows a set for a biopsy: a stencil navigation grid, a localization cube installed in the hole of the navigation grid, a biopsy needle installed in the localization cube.

In fig. 4, 5 show equipment for biopsy: automatic vacuum-cutting needle SurosSurgicalATEC™ 9G connected to a vacuum system.

In fig. 6, 7 show the stages of implementation of the proposed method.

The method is carried out as follows.

MP-controlled biopsy is performed on a high-field MP tomograph with a magnetic field inductance of 1.5-3 Tesla using a special open-type radiofrequency coil with the patient in the prone position with moderate fixation of one breast with a special BREAST BIOPSY KIT lattice (for example, manufactured by NORAS) , fig. 1-3.

Next, in the breastbiopsy mode, hardware localizer of the study boundaries is performed. Then, one series of dynamic T1 sequences and a bolus injection of paramagnetic contrast agent are performed, followed by the introduction of saline. After 5-20 seconds from the end of the injection, they are scanned to obtain post-contrast dynamic T1 images. At the end of the third post-contrast T1-VI, the location of the pathological formation or pathological area is determined in a three-coordinate system relative to the indicator cube installed in the lattice from the BREAST BIOPSY KIT.

Table 1 shows the MR biopsy pulse sequences.

Field of view 36 cm. Matrix 384×384.

Next, a localization cube from the localization kit is installed in the navigation grid and the hole closest to the projection of the pathological focus is selected.

After this, the stage of determining the location of the skin incision is performed.

A guide with an MR contrast rod is installed into the selected hole of the localization cube, bringing it directly to the skin pre-treated with an antiseptic. Next, a control abbreviated series of T1-weighted images (one series) is performed to clarify or correct the location of the incision. If in the computer program the virtual line extended from the end of the rod does not intersect or come into contact with the pathological area, then the stage of determining the location of the skin incision is repeated. Having ensured the correct position of the MP contrast rod relative to the pathological zone, the skin is re-treated with an antiseptic, anesthesia is administered (for example, 6 ml of a 2% lidocaine solution from the skin surface to the pathological zone) and an incision is made. After this, the MP-guided biopsy procedure continues as standard.

It is possible (not necessary) to conduct 1 series of T1-VI to re-clarify the location of the pathological zone.

After this, a plastic guide with an amagnetic trocar is inserted to the desired depth. The depth calculated in the computer program corresponds to the divisions on the guide. Next, the trocar is removed and an MP contrast rod is placed in the guide. A T1 control series is performed to determine the accuracy of the location of the guide with the rod relative to the pathological area.

After removing the rod, an automatic 9G vacuum-cutting needle, previously connected to the vacuum system, is inserted into the guide (Fig. 4, 5).

When the vacuum system is turned on, the needle aperture automatically retracts and cuts off sections of pathological tissue that fall into the compartment for the removed material.

If a biopsy is performed using an automatic BARDMagnum gun, 14G 16 cm and 12G 16 cm needles are used. In this case, a needle pre-tucked into the gun is inserted into the localizer guide until it stops. Fire from 4 to 6 shots.

After collecting 4-6 tissue samples, the needle is removed from the localizer guide and then the biopsy site is monitored in an MP tomograph using a T1 sequence.

If the evidential result of a correctly identified biopsy (absence of formation, its deformation), an MP-compatible tag is introduced through a localizer guide.

The biopsy is completed by applying a sterile sticker and issuing recommendations. The material in a 10% formalin solution is sent for histological examination.

Clinical example 1

The biopsy was performed on a high-field MP tomograph with the patient in the prone position with moderate fixation of one breast using a grid from the BREAST BIOPSY KIT.

Hardware localization of the study boundaries was carried out. One series of dynamic T1 sequences and a bolus injection of paramagnetic contrast agent in an amount of 10 ml were performed, followed by the introduction of 25 ml of saline. 10 seconds after the end of the injection, a scan was performed to obtain post-contrast dynamic T1 images. At the end of the third post-contrast T1-VI, the location of the pathological formation was determined in a three-coordinate system relative to the indicator cube installed in the lattice from the BREAST BIOPSY KIT.

The stage of determining the location of the skin incision was carried out.

A guide with an MR contrast rod is installed in the selected hole of the localization cube. The MP contrast rod is applied directly to the skin that has been pre-treated with an antiseptic. Next, a control abbreviated series of T1-VI was performed (one series). Using a computer program, it was revealed that a virtual line extended from the end of the rod crosses the pathological area. There is no need to repeat the step of determining the location of the skin incision. The skin is re-treated with an antiseptic. Anesthesia was performed with 6 ml of 2% lidocaine solution from the surface of the skin to the pathological area. A skin incision was made.

Next, a plastic guide with a magnetic trocar is inserted. The trocar is removed. An MP contrast rod is installed in the guide.

After removing the rod, an automatic 9G vacuum-cutting needle, previously connected to the vacuum system, is inserted into the guide.

6 tissue samples were collected. The needle is removed from the localizer guide. The biopsy site was monitored in an MP tomograph using a T1 sequence.

The biopsy is completed by applying a sterile sticker. The material in a 10% formaldehyde solution was sent for histological examination.

According to histological examination, the result was: atypical ductal hyperplasia on the right, which is not breast cancer, but requires surgical intervention.

Clinical example 2

The biopsy was performed on a high-field MP tomograph with the patient in the prone position with moderate fixation of one breast using a grid from the BREAST BIOPSY KIT.

Hardware localization of the study boundaries was carried out. One series of dynamic T1 sequences and a bolus injection of paramagnetic contrast agent in an amount of 15 ml were performed, followed by the introduction of 30 ml of saline. 15 seconds after the end of the injection, a scan was performed to obtain post-contrast dynamic T1 images. At the end of the third post-contrast T1-VI, the location of the pathological formation was determined in a three-coordinate system relative to the indicator cube installed in the lattice from the BREAST BIOPSY KIT. The stage of determining the location of the skin incision was carried out.

A guide with an MR contrast rod is installed in the selected hole of the localization cube. The MP contrast rod is applied directly to the skin that has been pre-treated with an antiseptic. Next, a control abbreviated series of T1-VI was performed (one series). Using a computer program, it was revealed that a virtual line extended from the end of the rod comes into contact with the pathological area. There is no need to repeat the step of determining the location of the skin incision. The skin is re-treated with an antiseptic. Anesthesia was performed with 6 ml of 2% lidocaine solution from the surface of the skin to the pathological area. A skin incision was made.

Next, a plastic guide with a magnetic trocar is inserted. The trocar is removed. An MP contrast rod is installed in the guide.

A biopsy was performed using a BARDMagnum automatic gun with a 14G 16 cm needle.

5 tissue samples were collected. The biopsy site was monitored in an MP tomograph using a T1 sequence.

The biopsy is completed by applying a sterile sticker. The material in a 10% formaldehyde solution was sent for histological examination.

According to the histological examination, the result was: on the right, ductal papilloma without signs of atypia.

Clinical Case 3

The biopsy was performed on a high-field MP tomograph with the patient in the prone position with moderate fixation of one breast using a grid from the BREAST BIOPSY KIT.

Hardware localization of the study boundaries was carried out. One series of dynamic T1 sequences and a bolus injection of paramagnetic contrast agent in an amount of 5 ml were performed, followed by the introduction of 20 ml of saline. 20 seconds after the end of the injection, a scan was performed to obtain post-contrast dynamic T1 images. At the end of the third post-contrast T1-VI, the location of the pathological formation was determined in a three-coordinate system relative to the indicator cube installed in the lattice from the BREAST BIOPSY KIT.

The stage of determining the location of the skin incision was carried out.

A guide with an MR contrast rod is installed in the selected hole of the localization cube. The MP contrast rod is applied directly to the skin that has been pre-treated with an antiseptic. Next, a control abbreviated series of T1-VI was performed (one series). Using a computer program, it was revealed that the virtual line extended from the end of the rod does not intersect or come into contact with the suspected pathological area. In this regard, the stage of determining the location of the skin incision was repeated; based on the results of repeating the stage using a computer program, it was revealed that the virtual line extended from the end of the rod intersects the supposed pathological area. The skin is re-treated with an antiseptic. Anesthesia was performed with 6 ml of 2% lidocaine solution from the surface of the skin to the pathological area. A skin incision was made.

Next, a plastic guide with a magnetic trocar is inserted. The trocar is removed. An MP contrast rod is installed in the guide.

A biopsy was performed using a BARDMagnum automatic gun with a 12G 16 cm needle.

4 tissue samples were collected. The biopsy site was monitored in an MP tomograph using a T1 sequence.

The biopsy is completed by applying a sterile sticker. The material in a 10% formaldehyde solution was sent for histological examination.

According to histological examination, the result was: atypical ductal hyperplasia on the left.

The proposed method makes it possible to almost completely eliminate erroneous incisions, which reduces trauma and reduces the risk (in the case of biopsy of malignant tumors) of iatrogenic dissemination of tumor cells.

Claims (6)

1. A method of MP-controlled breast biopsy, characterized in that at least one stage of determining the location of the skin incision is first performed, which includes installing a stencil from a biopsy kit on the skin in the area of the mammary gland, inserting a guide with MP into the selected hole of this stencil - a contrast rod, bringing the rod directly to the skin pre-treated with an antiseptic, performing a control abbreviated series of T1-weighted images (T1-weighted images), analyzing the resulting T1-weighted images with drawing a virtually straight line from the end of the rod, which is a continuation of this rod, and, if carried out the virtual line does not cross the supposed pathological area and does not come into contact with it, the stage of determining the location of the skin incision is repeated, and if the drawn virtual line crosses the supposed pathological area or comes into contact with it, then the skin is re-treated with an antiseptic, then anesthesia is performed, an incision is made in the skin treated with the antiseptic, a guide and a trocar are inserted into the tissue, which is then removed, and an MP-contrast rod is inserted into the guide, scanning is performed and material is taken for histological examination from the suspected pathological area. 2. The method according to claim 1, characterized in that the biopsy is performed using an automatic biopsy gun with a 14G 16 cm or 12G 16 cm needle. 3. The method according to claim 1, characterized in that the stencil is a grid with a localization cube from a biopsy kit, the localization cube is intended for inserting a biopsy needle through it, and the cube is designed to be installed in any of the grid holes. 4. The method according to claim 1, characterized in that the NORAS Breast Biopsy Kit is used. 5. The method according to claim 1, characterized in that the biopsy is performed with a 9G needle connected to a vacuum system. 6. The method according to claim 1, characterized in that during the biopsy, 4-6 tissue samples are taken.