RU2648004C1 - Method of marking a tumor lesion to visualize the necessary zone of breast resection (variants) - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions refers to surgery and can be used to mark a tumor lesion. Advance the needle-localizer to the first position of the introduction, at which point the advance of the needle-localizer is stopped and the first marker is squeezed out. Installation of the second and third markers is carried out without external resetting of the needle-localizer, for which the needle-localizer is pulled over itself through the wound course, at the same time, the angle of introduction of the needle-localizer is changed and the needle-localizer is advanced inward to the next insertion position, at which point the movement of the needle-localizer is stopped and squeeze the marker into the second and third injection positions respectively, after the introduction of the three markers, the needle-localizer is removed from the wound.

EFFECT: group of inventions allows to reduce traumatization, reduce the risk of contamination of surrounding tissues with tumor cells.

6 cl, 8 dwg

Description

The group of inventions relates to surgery, is intended to determine the location, size, shape of the tumor nodes for subsequent visualization of the necessary resection zone.

A device is known for interstitial labeling of a tumor, containing a puncture needle, mandrin, interstitial marker (RU 33855 U1, 11/20/2003).

A known method of introducing a marker into the tumor using a device that includes a needle, body, front and rear release buttons (Biological breast marker UltraClip ^® Dual Trigger. Instructions for use. BARD BIOPSY SYSTEMS. 07.2012).

It is known to introduce a marker into a tumor tissue using a device including a cannula, an adapter, an applicator, a plunger, and insert a marker by pressing the plunger (SenoMark UltraCor ™ MRI 14 Cauge Tissue Marker And Introducer Kit. Instructions for Use. BARD Biopsy, 05.2015).

A known method of marking a tumor for its visualization before neoadjuvant chemotherapy, including the introduction of a puncture needle into the tumor formation, the installation of a marker in the lumen of the puncture needle, pushing the marker through the mandrel into the tumor formation (RU 2242166 C2, 20.12.2004).

The disadvantages of the known methods and devices for inputting markers include the fact that if it is necessary to install multiple markers, several punctures are made. This contributes to additional trauma, increases the risk of contamination of surrounding tissues with cells from tumor nodes.

A technical problem when marking a tumor lesion is the additional trauma to the tumor and surrounding tissues, produced by marking devices, which contributes to the seeding of surrounding tissues with tumor cells.

The technical result of the proposed method is the possibility of multi-target marking of a single tumor node (intratumoral - with three markers inside the tumor; peritumoral - along the contour of the tumor, at the border with unchanged tissues), and separate marking of multifocal cancer (up to 3 tumor nodes within one quadrant of milk glands) through a single puncture of the skin and soft tissues under instrumental control (during ultrasound, mammography or MRI of the mammary glands). Such marking provides a reduction in damage to the tumor node during labeling, provides a significant reduction in the length of wound channels in the area of tumor damage, which helps to reduce tissue trauma and improve ablasticity (prevention of colonization of the mammary gland by tumor cells).

The specified technical result is provided by the method of marking the site of tumor lesion of the mammary gland without external reinstallation of the localization needle, in which, after a puncture of the skin and soft tissues, the localization needle with three markers is brought to the nearest edge of the tumor node, the localization needle is advanced to the first injection position, upon reaching where the advancement of the localization needle is stopped and the first marker is extruded, and the second and third marker are installed without external reinstallation of the localization needle, for which the localization needle is pulled over itself through the wound passage until the inner section of the needle is again in front of the nearest edge of the tumor node, while the angle of introduction of the localization needle into the tumor node is changed and the localization needle is moved deeper into the tumor node to the next injection position, upon reaching which the advancement of the localization needle is stopped and the marker is extruded into the second and third injection positions, respectively, after the introduction of three markers, the localization needle is removed from the wound passage.

In the particular case of the implementation of the method of intratumoral labeling, the first position of the introduction is in the Central part of the tumor node.

In the particular case of the method of peritumoral marking along the contour of the tumor, the first injection position is located on the border of the distal edge of the tumor node and unchanged tissues, the second injection position is on the border of the upper edge of the tumor node and unchanged tissues, and the third injection position is on the border of the lower edge of the tumor node and unchanged tissues.

The above technical result is also provided by the method of multi-target marking of up to three tumor foci within one quadrant of the mammary gland without external reinstallation of the localization needle, in which, after a puncture of the skin and soft tissues, the localization needle with three markers included in it is advanced to the center of the first tumor node, when the center of the first tumor node is reached, the advancement of the localizer needle is stopped and the first marker is extruded, the second marker is installed without external reinstallation the localization needle, for which the localization needle is pulled over itself through the cutaneous passage until the needle comes out completely from the tumor node, but without going out of the wound canal, the entrance angle of the localization needle is changed, the localization needle is advanced to the second tumor the node and injected into its center, upon reaching the center of the second tumor node, the localization needle advance is stopped, the second marker is pressed into the center of the second tumor node, the third marker is also installed without external reinstallation of the localization needle RA, for which the localization needle is again pulled over itself through the cutaneous passage until the localization needle comes out completely from the second tumor node, but without going out of the wound canal, the angle of introduction of the localization needle is changed, the localization needle is moved into the third tumor node, upon reaching the center of which the advancement of the localization needle is stopped and the third marker is extruded, and after the introduction of the markers, the localization needle is removed from the wound passage.

Promotion of the localization needle is carried out under instrumental control.

To perform the method, a device is used (Fig. 1-5).

FIG. 1: device assembly.

FIG. 2: needle handle.

FIG. 3: stock handle.

FIG. 4: needle with a handle.

FIG. 5: stock with handle.

A method for marking a tumor lesion is shown in FIG. 6-8.

FIG. 6: multi-intratumoral tumor labeling.

FIG. 7: multi-target peritumoral tumor labeling.

FIG. 8: multi-target labeling of a tumor consisting of three tumor nodes.

A device for introducing implants into the biological tissue of a patient contains a needle 1 in the form of a tube 50-250 mm long and an external diameter of 0.5-2.5 mm, in which three implants are placed in series, one stem 5 with a handle 2 and a removable protective lock 4 to prevent stem loss. At one end of the needle 1, the handle of the needle 3 is fixed, and its other end is made in the form of a pointed tip. Protective latch 4 is mounted on the handles of the needle and stem. The handle of the needle 3 is made in the form of a sleeve with four grooves, each groove has the shape of a parallelepiped, of various lengths, the grooves are located around the circumference at an angle of 90 ° to each other. The rod handle 5 at the end has a radial protrusion made in the form of a parallelepiped with the possibility of entering into the mentioned grooves of the sleeve. The rod 5 is made with the possibility of reciprocating motion inside the needle. The end of the rod, opposite the end of the rod handle, is made with the possibility of extruding the implants placed in the needle into the biological tissue. One of the four grooves of the sleeve - the zero groove - is designed to fix the rod, for example, during its transportation. The location of the protrusion of the rod handle in the zero groove prevents accidental operation of the device and prevents premature implant insertion. The other three - the first, second and third - are made of different lengths, which is calculated from the condition that the rod extrudes the corresponding implant placed in the needle. The zero groove is opposite the second groove and at an angle of 90 ° clockwise to the first groove and at an angle of 90 ° counterclockwise to the third groove. Thus, when the protrusion of the rod handle enters the first groove of the needle handle, the first implant located relative to the tip of the needle is squeezed out through the rod, when it enters the second groove, the second implant, and the third implant, in the third groove.

For the implementation of the method, markers (tags) are used, located at the tip of the tube sequentially one after another and intended for introduction into the human body and a long stay in it.

Markers (tags) are made of radiopaque material (example: titanium, gold), have a cylindrical or spherical shape, length from 0.3 to 10 mm, diameter from 0.3 to 2.0 mm. A variant of another shape of the marks is allowed having a circular cross section with a predetermined radius of curvature of the longitudinal axis to improve the fixation of the mark in the target area of the biological tissue.

The method is as follows.

Marking of the primary tumor is carried out before the start of preoperative drug therapy; under aseptic conditions after the introduction of a local anesthetic under instrumental control (ultrasound, MMG or MRI of the mammary glands) in the immediate vicinity of the tumor site (or tumor sites), the skin and soft tissues are punctured using a localization needle with three radiopaque markers included in it.

Further labeling of the solitary (single) tumor node can be carried out intratumoral (Fig. 6) or peritumoral (Fig. 7). The marking of the multicentric zone (up to three tumor nodes located in one quadrant of the mammary gland is done in a separate way (Fig. 8); each of the methods is performed without external reinstallation of the localization needle (after 1 puncture).

Clinical examples illustrating the implementation of the proposed method.

Patient A., 38 years old, was referred for cancer of the right breast, T2N0M0.

Before conducting preoperative chemotherapy, multi-target intratumoral tumor labeling was performed (Fig. 6). A localization needle 1 with three titanium markers included in it through a single puncture 4 is brought to the nearest edge of the tumor node 3 under instrumental control of an ultrasound transducer 2 and is advanced through the penetration into the central part of the tumor (6a). Upon reaching the required zone of installation of the first marker (determined by ultrasound data), the penetration of the localization needle is stopped and the first marker is extruded into the pathological zone by advancing the stem (6b). The second marker was installed without external rearrangement of the stylet of the needle: the localizer needle was pulled over itself through the skin passage until the inner section of the needle was again in front of the nearest edge of the tumor node (6c). The angle of entry into the tumor was changed, the localization needle was moved deeper into the tumor to another zone of the necessary marking, determined by ultrasound data, when this zone was reached, the penetration of the localization needle was stopped, and a second titanium marker was pressed into the pathological zone with the help of the rod (6 g). Installation of the third marker was carried out similarly: the localizer needle was again pulled over itself through the cutaneous passage until the internal section of the needle was in front of the nearest edge of the tumor node (6e). By changing the angle of entry into the tumor, the localization needle is advanced into the tumor node to the third zone of the necessary marking, determined by ultrasound, when the third zone of the necessary marking is reached, the penetration of the localization needle is stopped and the third marker is extruded into the pathological zone (6e). After the introduction of the markers, the localization needle along with the stem was removed from the wound passage (6g).

The patient underwent 6 cycles of the planned preoperative polychemotherapy, with a complete clinical and radiological response, the patient underwent subsequent radical organ-preserving treatment.

Patient Y., 44 years old, was referred for cancer of the right breast, T2N1M0.

Before conducting preoperative chemotherapy, multi-target peritumoral tumor labeling was performed (Fig. 7). From the nearest edge of the tumor node, the localization needle 1 through a single puncture 4 is introduced through penetration to the distal edge of the tumor node 3 (i.e., to the edge of the tumor node farthest from the operating surgeon), determined according to the ultrasound probe 2, when the distal the edges of the tumor node, the needle is stopped (7a). Using the rod, the first marker was squeezed into the tumor edge at the border with unchanged tissues from the localization needle (7b). The second and third markers were installed without external reinstallation of the localization needle. The localization needle is pulled over itself through the cutaneous passage until the inner section of the needle is again in front of the nearest edge of the tumor node (7c). With a change in the angle of entry into the tumor, the localization needle is advanced to the upper edge of the tumor under ultrasound control, when the upper edge of the tumor is reached, penetration is stopped and a second marker is extruded from the localization needle onto the border with unchanged breast tissue (7g). The localization needle is pulled up on itself until the tip of the needle is in front of the nearest edge of the tumor (7e). By changing the angle of administration, the localization needle is brought to the lower edge of the tumor. The third marker was squeezed with the help of the rod to the border with the unchanged breast tissue (7e), after which the localization needle and the rod were removed from the wound passage (7g).

The patient underwent 8 cycles of preoperative chemotherapy with a pronounced partial response (reduction in tumor size by 80%), the patient underwent subsequent organ-preserving treatment.

Patient N., 32 years old, referred for multifocal cancer of the left breast, T2N1M0 (3 nodes within the same quadrant of the breast).

Before conducting preoperative chemotherapy, multi-target tumor marking was performed (Fig. 8). After a single puncture of 4 skin and soft tissues under the instrumental control of an ultrasound transducer 2, the localization needle 1 is advanced to the center of the first tumor node 3 (8a). When the center of the node (determined by ultrasound) is reached, the needle is stopped and the first marker is extruded into the center of the first tumor node using the rod (86). The needle is pulled over so that it completely leaves the first tumor node (8c), but without an external exit from the wound channel. With a change in the angle of entry, the localizer needle is advanced to the second tumor node and penetrated into its center (8 g), when the center of the second tumor node is reached, the needle advance is stopped and a second marker (8e) is extruded into the pathological zone using the rod. Next, the localization needle is pulled over so that it completely leaves the second tumor node, but without an external exit from the wound channel (8e). With a change in the angle of entry, the localizer needle is brought to the third tumor node and inserted into its center under the control of ultrasound (8g). After reaching the center of the third tumor node, the advancement of the localization needle was stopped and the third marker was squeezed into the tumor node (8h). After installing the third marker, the localization needle along with the rod was removed from the wound channel (8i).

The patient underwent 6 cycles of preoperative chemotherapy with a complete clinical and radiological response. The patient performed the planned organ-preserving operation.

Claims (6)

1. A method for marking the site of a tumor lesion of the mammary gland without external reinstallation of the localization needle, characterized in that after a puncture of the skin and soft tissues, the localization needle with three markers is brought to the nearest edge of the tumor node, the localization needle is advanced to the first injection position, upon reaching where the advancement of the localization needle is stopped and the first marker is extruded, and the second and third marker are installed without external reinstallation of the localization needle, for which the localization needle is pulled and yourself through the wound passage until the inner section of the needle is again in front of the nearest edge of the tumor node, while changing the angle of insertion of the localization needle into the tumor node and move the localization needle deep into the tumor node to the next injection position, at which achievement the localization needles are stopped and the marker is extruded into the second and third injection positions, respectively, after the introduction of three markers, the localization needle is removed from the wound passage. 2. The method according to p. 1, in which the promotion of the needle-localizer is carried out under instrumental control. 3. The method according to p. 1, in which the first position of the introduction is in the Central part of the tumor node. 4. The method according to claim 1, in which the first position of the introduction is on the border of the distal edge of the tumor node and unchanged tissues, the second position of the introduction is on the border of the upper edge of the tumor node and unchanged tissues, and the third position of the introduction is on the border of the lower edge of the tumor node and unchanged tissues. 5. A method for multi-target marking of three tumor nodes within one quadrant without external reinstallation of the localization needle, characterized in that after a puncture of the skin and soft tissues, the localization needle with three markers included in it is advanced to the center of the first tumor node, upon reaching the center of the first tumor of the site, the advancement of the localization needle is stopped and the first marker is extruded, the second marker is installed without external reinstallation of the localization needle, for which the localization needle is pulled to through the skin passage until the needle comes out completely from the tumor node, but without leaving the wound canal, the entrance angle of the localization needle is changed, the localization needle is advanced to the second tumor node and inserted into its center, when the center of the second the tumor node stop the progression of the localization needle, squeeze the second marker into the center of the second tumor node, the installation of the third marker is also carried out without external reinstallation of the localization needle, for which the localization needle is again pulled onto itself through to the correct course until the localization needle comes out completely from the second tumor node, but without going outside the wound canal, the angle of introduction of the localization needle is changed, the localization needle is moved into the third tumor node, when the center of the needle is stopped, localizer and squeeze the third marker, and after the introduction of the markers, the needle-localizer is removed from the wound passage. 6. The method according to p. 5, in which the promotion of the needle-localizer is carried out under instrumental control.

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