CN111772815A - Noninvasive lesion positioning method and application - Google Patents
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- A—HUMAN NECESSITIES
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Abstract
The invention belongs to the technical field of focus positioning, and particularly relates to a noninvasive focus positioning method and application. Combining the image detection data and the physical examination positioning data of the focus, firstly using an oily pen to draw the focus range on the skin of a detected person, and then cutting a coating film by using a transparent film, wherein the coating film can cover the body surface characteristic structure of the diseased organ; the covering film is tightly attached to the skin of a subject, the edge of a focus is traced on the covering film by an oil pen, and at least the body surface characteristic structure of a diseased organ is marked; marking the basic information and the checking time of the examined person to obtain a focus condition membrane, and filing for later use. The steps are repeated in the subsequent diagnosis and treatment process, so that the change conditions of the focus before and after treatment are visually compared. The invention has the advantages of simple and easily obtained materials, low cost, simple and convenient operation and high safety, and is suitable for the positioning marking of the focus which is close to the body surface and can be touched by hands.
Description
Technical Field
The invention belongs to the technical field of focus positioning, and particularly relates to a noninvasive focus positioning method and application.
Background
With the development of breast cancer treatment technology, prognosis is continuously improved. Due to the continuous deepening of understanding of breast cancer disease rules, the selection of a reasonable treatment scheme enables the mortality rate to be only 9.90/10 ten thousand under the condition that the breast cancer prevalence rate in China reaches 41.82/10 ten thousand in recent years. For social and psychological reasons, more and more patients are expected to receive breast protection treatment with reduced recent and long-term physical and psychological trauma associated with breast cancer surgery. Meanwhile, for the related breast cancer patients who cannot accept the first-stage operation and have the requirement of breast preservation or need to obtain in-vivo drug sensitivity information, the new adjuvant therapy becomes a conventional treatment mode widely developed by various breast cancer treatment centers.
Neoadjuvant chemotherapy refers to chemotherapy performed before surgery. Neoadjuvant chemotherapy for breast cancer patients is mainly seen in several cases: the first, some patients have large tumor, and have certain difficulty in direct operation, and the tumor is reduced by the new auxiliary chemotherapy, thereby creating conditions for the operation; secondly, part of patients do not want to receive full-cutting operation of breasts and want to reserve part of breasts, and the breast conservation operation rate can be improved through new auxiliary chemotherapy; thirdly, in the process of the new adjuvant therapy, the sensitive reaction of the focus to the medicine can be used as the basis for further adjusting the medicine. In addition, it has been shown from clinical studies that patients who develop pCR (complete remission of the pathology) after receiving neoadjuvant therapy can achieve lower relapse rates. According to 2019 of the CBCS chinese anticancer association breast cancer diagnosis and treatment guidelines and specifications, the following patients recommend new adjuvant chemotherapy: 1) the clinical stages are stage IIIA (without T3, N1 and M0), IIIB and IIIC. 2) The clinical stages are IIA, IIB and IIIA (T3N 1M 0 only), and the patient who wants to reduce the tumor mass and reduce the period and preserve the milk can be considered as new adjuvant chemotherapy.
Fisher et al have shown the equivalence of neoadjuvant chemotherapy for breast cancer, and research and clinical practice for neoadjuvant therapy is increasing. When a patient is operated after a new adjuvant therapy in breast surgery, the positioning problem of partial or complete alleviation of the breast lesion of the patient after the therapy is firstly faced. To achieve good efficacy, it is generally recommended that the patient be marked with a primary lesion area prior to initial treatment, usually with ultrasound-guided implantation of a metal marker or skin epidermal localization.
In clinical application, the commonly used lesion marking methods can be roughly classified into a body surface tattoo method, a metal marker method, a coordinate marking method and a body membrane marking method. The above 4 methods have respective advantages and disadvantages: (1) body surface tattooing method: reliable marking, which is suitable for swelling, but requires the purchase of a specialized tattoo machine, the injection of a dye into the epidermis layer of the skin, invasive procedures, which require local anesthesia. Patients have pain and discomfort, if the patients receive new auxiliary treatment for a long time, the dyes may fade, and the patients need to be tattooed again, so that the patients are subjected to repeated physical trauma, and the medical cost is increased; (2) metal marker method: the positioning is carried out under the support of ultrasound, which is more accurate, but needs professional personnel and equipment to operate, and only metal markers can be placed at the center and the boundary of the lesion to carry out point marking, but continuous marking cannot be realized. If the tumor is a lesion with irregular shape, the marking effect is not good. After the marker is placed, the patient can be subjected to strong external force such as breast molybdenum target examination and the like to compress the breast, and the marker can be displaced. In the course of treatment, the lesion changes, and the change of the lesion cannot be recorded continuously. When a patient is subjected to an operation, the operator may not easily determine the operation range by only positioning the marker clip, and an auxiliary guide wire and the like are needed. (3) A coordinate method: the nipple is used as the origin, the focus is digitally recorded by adopting a mathematical coordinate method, the marking point is more accurate and easy to record, but the focus edge cannot be completely marked, and the marking effect is poor for the crab-foot-shaped edge of the breast cancer focus. (4) Body membrane marking method: the method can continuously mark the focus, can accurately describe the focus with irregular edge, can repeatedly mark and has good patient compliance. However, the area of the ulnar membrane (CN 201642096U), a breast tumor surface locating membrane, is large, and the marking requires complete coverage of all or most of the mammary glands, which is complicated to operate in cases of large and prolapsed breasts and the like. In addition, the shape of the lesion is cut out for each marking, and the marking comparison cannot be repeated on the same membrane.
Disclosure of Invention
In view of the above technical problems in the background art, there is a need to provide a non-invasive lesion localization method and its application, which is simple and convenient in procedure, easy to operate, non-invasive and painless and highly safe for the patient to whom the method is applied.
To this end, in a first aspect of the present invention, the inventors provide a method of non-invasive lesion localization, comprising the steps of:
s1: acquiring image detection data of a focus;
s2: acquiring physical examination positioning data of a focus, wherein the physical examination positioning data is acquired by touching the focus by a hand of an examiner;
s3: combining the image detection data and the physical examination positioning data to draw a focus range on the skin of the examined person;
s4: cutting a covering film by using a transparent film, wherein the covering film can cover the body surface characteristic structure and all focuses of the diseased organ;
s5 includes the following: a step of tightly attaching the covering film to the skin of a subject, a step of tracing the focus edge on the covering film by an oil pen, and a step of marking the body surface characteristic structure of the diseased organ on the covering film;
s6: marking the basic information and the checking time of the examined person to obtain a focus condition membrane, and filing for later use.
In a specific operation, the sequence of the step S1 and the step S2 of obtaining the image detection data and the physical examination location data of the lesion may be adjusted. The image detection data is body surface projection data obtained by ultrasonic or other image detection methods. And in the step S5, an oil pen is adopted, such as a daily oil marker pen, so that the mark can be made, the line marked by the oil pen is firm, the mark cannot fade when meeting heat in water, and the waterproof performance is good. And when the focus needs to be positioned in the subsequent diagnosis and treatment process, repeating the steps S1-S6.
In some preferred embodiments, the cover film is a PET self-adhesive transparent film. The PET transparent adhesive sticker film has a transparent surface, does not have a grid printed in advance, is easy to obtain materials, can be cut and marked at will according to the size of a focus, and can be directly regarded as a single plane for a small focus without considering the three-dimensional shape. In the using process, the edges of the PET non-setting adhesive transparent films can be continuously drawn, the same PET non-setting adhesive transparent film can be repeatedly marked, the size and the filing are easy to measure, and the change conditions of the focus before and after treatment can be visually compared to evaluate the treatment effect.
More preferably, the thickness of the PET non-setting adhesive transparent film is equal to or less than 20 μm. A pressure-sensitive adhesive transparent film having a larger thickness may of course be used, but a pressure-sensitive adhesive transparent film having a thickness of 20 μm or less is more effective in terms of the degree of adhesion to the skin of the body and the drawing accuracy.
In some exemplary embodiments, the steps of acquiring the image detection data of the focus and acquiring the physical examination positioning data of the focus take the position of the subject required for treatment and abduct the affected side.
Preferably, the lesion situation membrane is reusable.
In particular, the inventors also provide the use of the lesion localization method according to the first aspect of the invention in a method for neoadjuvant treatment of breast cancer, preferably, the use comprises the steps of:
s01: the examinee takes a horizontal position to obtain the image detection data of the focus;
s02: acquiring physical examination positioning data of a focus, wherein the physical examination positioning data is acquired by touching the focus by a hand of an examiner;
s03: combining the image detection data and the physical examination positioning data to draw a focus range on the skin of the examined person;
s04: cutting a covering film by using a transparent film, wherein the covering film can cover the body surface characteristic structures of diseased organs such as nipples, areola areas, lumps and the like;
s05: tightly attaching the covering film to the breast skin, tracing the focus edge on the covering film by using an oil pen, and marking the body surface characteristic structures, biopsy pinholes, upper and lower quadrant dividing lines of diseased organs such as the central clavicle, the nipple and the areola area;
s06: marking the basic information and the checking time of the examined person to obtain a focus condition membrane, and filing for later use.
In some exemplary operations, the sequence of steps S01 and S02 for acquiring the image detection data of the lesion as ultrasound projection data, particularly B-ultrasound projection data, and physical examination positioning data may be adjusted. And in the step S05, an oil pen, such as an oil marking pen used in daily life, is adopted for marking, and the drawn lines are firm, do not fade when meeting water and are good in waterproof performance. When the focus needs to be positioned in the subsequent diagnosis and treatment process of the examinee, the steps S01-S06 are repeated, and the focus condition membrane can be reused as a covering membrane.
Different from the prior art, the technical scheme at least has the following beneficial effects:
in clinical practice, focus data results obtained by B ultrasonic image detection data and physical examination positioning are combined to a simple film label, so that the method is noninvasive for a detected person/patient, the raw material source is convenient, the cost is low, the operation is time-saving and simple, the patient is easy to accept, the positioning effect is good, the technology is easy to learn for an implementer, and the implementation can be mastered through simple training. The noninvasive lesion positioning method can dynamically observe the change condition of the primary lesion of the mammary gland in new auxiliary treatment so as to visually track the treatment effect. Before the mammary gland operation is prepared, the non-invasive lesion positioning method provided by the invention can accurately reproduce the original range and position of the lesion, and avoid the situation that the original lesion is reduced or disappeared to cause difficult positioning after new auxiliary treatment.
Drawings
FIG. 1 is a schematic projection of a body surface tracing lesion according to an embodiment;
FIG. 2 is a schematic view of the embodiment relating to marking of lesion margins, mid-clavicular line, nipple, areola area, biopsy needle hole and upper and lower quadrant demarcation lines on the cover film;
FIG. 3 is a schematic diagram of a patch according to an embodiment of the present invention;
FIG. 4 is a graph of the distribution frequency of the difference between the longest diameter difference for initial diagnosis, the maximum margin difference for initial diagnosis, and the longest diameter difference before and after operation in accordance with an exemplary embodiment;
FIG. 5 is a frequency distribution diagram of the non-overlapping area of the pasting method and the secondary ultrasound drawing in the embodiment;
FIG. 6 is a diagram illustrating a percentage distribution of an area where the decal method and the secondary ultrasound drawing do not overlap to a total area of the ultrasound drawing in the embodiment;
FIG. 7 shows the following. In the specific embodiment, the maximum diameter difference of initial diagnosis, the maximum margin difference of initial diagnosis, the non-overlapped area of initial diagnosis and the maximum diameter difference of preoperative and postoperative are shown in a box-shaped graph.
Detailed Description
To explain technical contents, structural features, and objects and effects of the technical solutions in detail, the following detailed description is given with reference to the accompanying drawings in conjunction with the embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present application.
The word "preferably" is used herein to refer to embodiments of the invention that provide certain benefits under certain circumstances. However, other embodiments may be preferred, under the same or other circumstances. Furthermore, recitation of one or more preferred embodiments does not imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the invention.
In one embodiment of the present invention, 50 breast cancer patients who were treated by breast surgery are used as samples, diagnosis of invasive breast cancer is confirmed by histopathological biopsy before treatment, and the selected patients meet the recommended content of new adjuvant therapy related to the breast cancer diagnosis and treatment standard and guideline (2019 edition) of the Chinese anticancer society, and are patients who are in clinical stage II and stage III and are intentionally willing to carry out new adjuvant therapy. The selected patients were subjected to surgery related to breast cancer after the completion of neoadjuvant therapy, and then routine pathological examination was performed. 50 patients are female, the age is 37-69 years, the average age is 51.2 years, the clinical stages are II stage and III stage, the longest diameter of the focus is 3-9cm in the initial diagnosis by ultrasonic measurement, the average size is 4.42cm, and no obvious skin invasion exists. 15 cases of lesions located in the upper outer quadrant, 10 cases of lesions located in the upper inner quadrant, 8 cases in the lower outer quadrant, 8 cases in the lower inner quadrant, and 9 cases in the nipple areola region.
When the noninvasive lesion positioning method provided by the invention is adopted, a patient takes a horizontal position required in a mammary gland treatment operation, a thin pillow or other cushions with certain elasticity are padded under the shoulder of an affected side, and the upper limb is abducted to be similar to the body position in the operation as much as possible. After the body surface projection of the breast lesion is determined by a method of combining the results of the B-ultrasonic examination and the physical examination localization (the sequence of the B-ultrasonic examination and the physical examination localization is not particularly required, the B-ultrasonic examination localization can be performed first and then the physical examination localization is performed, or the B-ultrasonic examination data can be other image projection data in other embodiments), an oily mark pen is used to trace the lesion range on the skin (see fig. 1). Cutting a PET non-setting adhesive transparent film with the thickness of 20 mu m into a film with a proper size according to the size of a focus, specifically, the size of the film can cover all body surface characteristic structures and lumps such as a nipple, an areola area and the like, tightly attaching the film to the breast skin as much as possible, tracing the focus edge on the film by a mark pen, and marking a clavicle midline, a nipple areola area, a biopsy pinhole and upper and lower quadrant dividing lines for reference (see fig. 2). After the marked overlay film is taken down, the basic information and the examination time of the patient are marked to obtain a focus condition film, and the film is filed/filed for later use (see fig. 3).
In the subsequent diagnosis and treatment process, if a focus range needs to be marked on the mammary gland of a patient, the boundary lines of the inner, the outer, the upper and the lower quadrants of the mammary gland and corresponding body surface marks are marked in the mammary gland area of the affected side of the patient as an auxiliary, the previously made adhesive film is adhered on the skin of the mammary gland according to the marking lines and the positions of the nipple and the areola, and the corresponding focus range can be marked according to the lump boundary drawn on the adhesive film. The above method is repeatedly used, and the focus condition membrane is repeatedly used, so that the primary focus change of the mammary gland can be dynamically observed in the new auxiliary treatment, and the treatment effect can be intuitively tracked. Before the preparation of mammary gland operation, the method can accurately reproduce the original range and position of the focus, and avoid the situation that the original focus is reduced or disappeared to cause difficult positioning after new auxiliary treatment.
The following method is adopted for verifying the accuracy of the method:
for a patient with initial diagnosis and initial treatment, the position of a focus is traced by a film pasting positioning method according to the method, ultrasonic secondary positioning is carried out, the difference value of the longest path and the difference value of the maximum edge distance of two different methods are measured, the area of the part which is not overlapped in the film pasting method compared with the ultrasonic secondary positioning is calculated by ImageJ software, and the percentage of the part area to the total area traced by the ultrasonic is calculated. For the patient ready for operation, if the preoperative assessment indicates that the disease is stable or partially relieved and the focus is larger than 1cm, the film pasting positioning is performed before the operation to determine the maximum diameter value of the focus, and the difference value between the maximum diameter value of the focus and the maximum diameter value of the focus obtained by the operation pathology is calculated. The distribution of the frequency of each difference value is analyzed by using a histogram, and the distribution characteristics of area data are analyzed by a Shapiro-Wilk test of a non-parametric test performed by a scatter diagram and SPSS10.0 software so as to evaluate the accuracy of the method disclosed by the invention.
The non-invasive focus positioning method provided by the invention is adopted by the initial patient to compare the focus graph drawn by the secondary independent ultrasound and the longest path of the postoperative pathology, and the frequency distribution of the difference values of the longest path of the initial diagnosis, the maximum margin distance of the initial diagnosis and the longest menstrual difference before and after the operation is shown in figure 4. As can be seen from FIG. 4, the longest diameter difference of the initial diagnosis is (0.08 + -0.1) cm, the largest margin difference of the initial diagnosis is (0.1+0.16) cm, the longest diameter difference before and after the operation is (0.03+0.18) cm, the frequency of the above three length difference values is mainly distributed in (0.1-0.2) cm, and the precision can meet the clinical routine requirement for the positioning of the breast lesion. The non-invasive focus positioning method provided by the invention has the non-coincident area of (2.5+3.12) cm with ultrasonic drawing2Compared with the area difference of the non-coincident parts of the focus scanned by secondary ultrasound, the non-invasive focus positioning method has the advantages that the percentage is in normal distribution, the P is 0.296(Shapiro-Wilk test), the absolute value is less than 14 percent, and the method is concentrated on 60cm2Hereinafter (see fig. 6). The result of the box diagram analysis of the data is shown in fig. 7, and the analysis of fig. 7 shows that the variance of each group of difference values is 0-2 and is close to the box body, so that the requirements of clinical diagnosis and treatment are met.
Compared with a body surface tattooing method and a metal marking method, the noninvasive lesion positioning method and the application provided by the invention are noninvasive operations, the patient acceptance is high, the lesion condition membrane can be filed, stored and reused, and the problems of displacement of a metal marker and the like are avoided. Moreover, the comparison with postoperative pathological data shows that the technology provided by the invention has high data accuracy for positioning and marking the focus. In addition, because the materials required by the technology are easy to obtain, the cost is low, the technical principle and the operation are simple and easy to learn, the safety is high, the management is convenient, and the method is very suitable for popularization and application in the aspect of positioning and marking the tumor focus (such as soft tissue tumor of limbs or trunk, suspicious mole on the body surface and the like needing follow-up observation) which is close to the body surface and can be touched.
It should be noted that, although the above embodiments have been described herein, the invention is not limited thereto. Therefore, based on the innovative concepts of the present invention, the technical solutions of the present invention can be directly or indirectly applied to other related technical fields by making changes and modifications to the embodiments described herein, or by using equivalent structures or equivalent processes performed in the content of the present specification and the attached drawings, which are included in the scope of the present invention.
Claims (9)
1. A noninvasive lesion positioning method is characterized by comprising the following steps:
s1: acquiring image detection data of a focus;
s2: acquiring physical examination positioning data of a focus, wherein the physical examination positioning data is acquired by touching the focus by a hand of an examiner;
s3: combining the image detection data and the physical examination positioning data to draw a focus range on the skin of the examined person;
s4: cutting a covering film by using a transparent film, wherein the covering film can cover the body surface characteristic structure and all focuses of the diseased organ;
s5 includes the following: a step of tightly attaching the covering film to the skin of a subject, a step of tracing the focus edge on the covering film by an oil pen, and a step of marking the body surface characteristic structure of the diseased organ on the covering film;
s6: marking the basic information and the checking time of the examined person to obtain a focus condition membrane, and filing for later use.
2. The lesion localization method of claim 1, wherein the coating film is a PET sticker transparent film.
3. The lesion localization method according to claim 2, wherein the thickness of the PET sticker transparent film is equal to or less than 20 μm.
4. The lesion localization method according to claim 1, wherein the steps of acquiring the image detection data of the lesion and acquiring the physical examination localization data of the lesion are performed by taking a posture of the subject required for treatment.
5. The lesion localization method of claim 1, wherein the lesion status membrane is reusable.
6. Use of a lesion localization method according to any one of claims 1 to 5 in a method of neoadjuvant treatment of breast cancer.
7. Use according to claim 6, characterized in that it comprises the following steps:
s01: the examinee takes a horizontal position to obtain the image detection data of the focus;
s02: acquiring physical examination positioning data of a focus, wherein the physical examination positioning data is acquired by touching the focus by a hand of an examiner;
s03: combining the image detection data and the physical examination positioning data to draw a focus range on the skin of the examined person;
s04: cutting a covering film by using a transparent film, wherein the covering film can cover nipples, areola areas and lumps;
s05: tightly attaching the covering film to the breast skin, tracing the focus edge on the covering film by using an oil pen, and marking a clavicle midline, a nipple, an areola area, a biopsy needle hole and upper and lower quadrant dividing lines;
s06: marking the basic information and the checking time of the examined person to obtain a focus condition membrane, and filing for later use.
8. The use of claim 7, wherein the image detection data is ultrasound projection data.
9. The use of claim 8, wherein the ultrasound projection data is B-mode ultrasound projection data.
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CN116407168A (en) * | 2023-05-16 | 2023-07-11 | 杭州丽康医学科技有限公司 | Biopsy device with focus marker imbedding function and application method |
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