Positioning device for sentinel lymph nodes of breast cancer

Abstract

The invention discloses a breast cancer sentinel lymph node positioning device. The positioning device comprises a laser transmitter and a probe device arranged on the laser transmitter in a covering mode, the probe device comprises a flexible circuit substrate and a plurality of sets of piezoelectric type miniature ultrasonic transducers arranged on the flexible circuit substrate in an array mode, every two adjacent sets of piezoelectric type miniature ultrasonic transducers are mutually spliced, and the piezoelectric type miniature ultrasonic transducers are arranged on the flexible circuit substrate in an array mode. Each piezoelectric miniature ultrasonic transducer comprises a plurality of ultrasonic units, each ultrasonic unit defines an accommodating space, and a lead zirconate titanate block bonded with the ultrasonic units is arranged in the accommodating space. The lead zirconate titanate block material and the piezoelectric type miniature ultrasonic transducer are integrated on the flexible circuit substrate, so that the probe device can completely cover a mammary gland lymph drainage area, the walking track of a lymph node tracer agent in a lymphatic vessel is dynamically tracked, the whole-process dynamic tracking is realized, and the position of a sentinel lymph node is accurately identified and positioned.

Description

Technical Field

[0001] The invention belongs to the field of medical technology, and in particular relates to a positioning device for sentinel lymph nodes of breast cancer. Background Art

[0002] The incidence of breast cancer has increased year by year, and its incidence has ranked first among female malignant tumors. It is one of the major diseases that seriously threaten women's health. Regional lymph node metastasis is the main way of breast cancer metastasis, of which about 70% metastasize through the axillary lymph nodes (ALN). The traditional way to treat breast cancer is modified radical mastectomy, that is, ipsilateral mastectomy and axillary lymph node dissection (ALND). The axillary lymph nodes are removed first, and then pathological examination is performed to determine whether metastasis has occurred, which serves as a reference for prognosis and whether further chemotherapy is needed. However, ALND is not only unnecessary for breast cancer patients without axillary lymph node metastasis, but also easily leads to complications such as upper limb lymphedema, pain, movement and sensory disorders. Therefore, before using the ALND method, determining whether breast cancer has metastasized to the axillary lymph nodes is an important factor in determining the stage of breast cancer, choosing the surgical method and evaluating the patient's prognosis.

[0003] At present, the clinical method of determining whether breast cancer has metastasized to the axillary lymph nodes is usually the sentinel lymph node biopsy (SLNB), which means first finding the sentinel lymph node (SLN), and then determining the surgical plan after the biopsy. If there is no metastasis, ALND is not required. Before performing SLNB, the location of SLN must be determined first. The current SLN localization methods mainly include dye method, radionuclide method, and dye-nuclide combined method.

[0004] However, existing SLN localization and detection technologies cannot accurately locate SLN in real time and dynamically. The location and number of SLNs in different patients vary greatly, which is affected by the experience of the surgeon and can easily lead to surgical failure or omission, affecting the reliability of SLN biopsy. Summary of the invention

[0005] In view of this, the purpose of the present invention is to provide a positioning device for sentinel lymph nodes of breast cancer, aiming to solve the technical problem of how to perform real-time dynamic and accurate positioning of sentinel lymph nodes.

[0006] To achieve the above-mentioned purpose, the present invention provides the following technical solutions: a device for locating sentinel lymph nodes of breast cancer, comprising a laser transmitter, and a probe device which is covered on the laser transmitter and used to track a tracer injected into the subcutaneous part of the human areola to generate a photoacoustic signal, and simultaneously receives the photoacoustic signal to achieve accurate positioning of the sentinel lymph nodes, the probe device comprising a flexible circuit substrate, and a plurality of groups of piezoelectric micro-ultrasonic transducers arranged in an array on the flexible circuit substrate, two adjacent groups of piezoelectric micro-ultrasonic transducers are spliced ​​with each other, each of the piezoelectric micro-ultrasonic transducers comprises a plurality of ultrasonic units, each of the ultrasonic units encloses an accommodation space, and a lead zirconate titanate block bonded to the ultrasonic unit is built in the accommodation space.

[0007] Furthermore, the ultrasonic units are arranged in a hexagonal shape.

[0008] Furthermore, it also includes a main control unit for controlling the laser transmitter to emit laser, an amplification and filtering unit for amplifying and filtering the photoacoustic signal received by the probe device and transmitting the filtered photoacoustic signal to the main control unit, and a display unit for connecting to the main control unit to display the movement trajectory of the tracer.

[0009] Furthermore, the piezoelectric micro ultrasonic transducer is manufactured by processing silicon-based materials using a micro-electromechanical system.

[0010] Furthermore, each of the plurality of groups of piezoelectric micro-ultrasonic transducers tracking the tracer satisfies the following relationship:

[0011] R n -R 1 =C(t n -t 1 )

[0012] In the formula, R n is the position of the nth piezoelectric micro-ultrasonic transducer; R 1 is the position of the first piezoelectric micro-ultrasonic transducer, C is the air propagation velocity; t n is the absolute transmission time of the sound source signal to the nth piezoelectric micro-ultrasonic transducer; t 1 is the absolute transmission time from the sound source signal to the first piezoelectric micro-ultrasonic transducer.

[0013] Furthermore, the preparation method of the probe device comprises the following steps:

[0014] S01: dividing the flexible circuit substrate into a plurality of array elements, and mounting the piezoelectric micro ultrasonic transducer at each array element position of the flexible circuit substrate at 280-350° C.;

[0015] S02: opening a hole in the flexible circuit substrate, and placing the lead zirconate titanate block in the hole;

[0016] S03: Bonding the lead titanate block to the piezoelectric micro ultrasonic transducer through an adhesive.

[0017] Furthermore, the step S03 further includes:

[0018] The lead titanate block and the piezoelectric micro ultrasonic transducer bonded by an adhesive are placed in a baking oven with a baking temperature of 50-70° C. and a baking time of 30 minutes.

[0019] The beneficial effects of the present invention are as follows: compared with the prior art, a breast cancer sentinel lymph node positioning device in the present invention emits a pulsed laser of a specific frequency through a laser transmitter, thereby interacting with a subcutaneous tracer injected into the human areola, and stimulating the tracer to emit a photoacoustic signal according to the photoacoustic effect; by selecting a probe formed by a composite of a lead zirconate titanate block and a piezoelectric micro-ultrasonic transducer, a larger emission sound pressure can be provided by the lead zirconate titanate block, thereby enhancing the strength and penetration of the ultrasonic signal; by selecting a piezoelectric micro-ultrasonic transducer and integrating it on a flexible circuit substrate, the formed probe device has the characteristics of small size and low power consumption, and is easier to be integrated into a portable or minimally invasive medical device; by integrating both the lead zirconate titanate block and the piezoelectric micro-ultrasonic transducer on a flexible circuit substrate, the probe device can fully cover the breast lymphatic drainage area, implement dynamic tracking of the trajectory of the lymph node tracer in the lymphatic vessels, realize full-process dynamic tracking, and accurately identify and locate the sentinel lymph node position.

[0020] Other advantages, objectives and features of the present invention will be described in the following description and will be apparent to those skilled in the art to some extent, or those skilled in the art may be taught from the practice of the present invention. The objectives and other advantages of the present invention may be realized and obtained through the following description. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to make the purpose, technical solution and beneficial effects of the present invention clearer, the present invention provides the following drawings for illustration:

[0022] Figure 1 A schematic diagram of the structure of a method and device for locating sentinel lymph nodes of breast cancer proposed in one embodiment of the present invention;

[0023] Figure 2 A schematic diagram of the structure of a probe device according to an embodiment of the present invention;

[0024] Figure 3 The present invention provides a flow chart of a manufacturing process of a probe device according to an embodiment of the present invention.

[0025] Figure Number:

[0026] 1-Laser transmitter;

[0027] 2-probe device; 21-flexible circuit substrate; 22-piezoelectric micro ultrasonic transducer; 221-ultrasonic unit; 222-accommodating space; 23-lead zirconate titanate block;

[0028] 3- Main control unit;

[0029] 4- Amplification and filtering unit;

[0030] 5- Imaging unit. DETAILED DESCRIPTION

[0031] like Figure 1 to Figure 2 As shown, this embodiment proposes a positioning device for sentinel lymph nodes of breast cancer, including a laser transmitter 1 and a probe device 2, the probe device 2 is covered on the laser transmitter 1, and the probe device 2 can be used to track the tracer injected into the subcutaneous part of the human areola to generate a photoacoustic signal, and simultaneously receive the photoacoustic signal to achieve accurate positioning of the sentinel lymph node. Specifically, the probe device 2 includes a flexible circuit substrate 21 and a plurality of groups of piezoelectric micro-ultrasonic transducers 22, each group of piezoelectric micro-ultrasonic transducers 22 is arranged in an array on the flexible circuit substrate 21, two adjacent groups of piezoelectric micro-ultrasonic transducers 22 are spliced ​​with each other, each piezoelectric micro-ultrasonic transducer 22 includes a plurality of ultrasonic units 221, each ultrasonic unit 221 encloses a housing space 222, a lead zirconate titanate block 23 is built in the housing space 222, and the lead zirconate titanate block 23 is bonded to the ultrasonic unit 221. A pulsed laser of a specific frequency is emitted by the laser transmitter 1, so that it can interact with the subcutaneous tracer injected into the human areola, and stimulate the tracer to emit a photoacoustic signal according to the photoacoustic effect; by selecting a probe formed by a composite of a lead zirconate titanate block 23 and a piezoelectric micro-ultrasonic transducer 22, a larger emission sound pressure can be provided by the lead zirconate titanate block 23, thereby enhancing the strength and penetration of the ultrasonic signal; by selecting the piezoelectric micro-ultrasonic transducer 22 and integrating it on the flexible circuit substrate 21, the formed probe device has the characteristics of small size and low power consumption, and is easier to be integrated into portable or minimally invasive medical equipment; by integrating the lead zirconate titanate block 23 and the piezoelectric micro-ultrasonic transducer 22 on the flexible circuit substrate 21, the probe device can fully cover the breast lymphatic drainage area, implement dynamic tracking of the trajectory of the lymph node tracer in the lymphatic vessels, realize dynamic tracking of the whole process, and accurately identify and locate the sentinel lymph node position.

[0032] In the present application, by setting up multiple groups of miniature ultrasonic transducers 22, multiple photoacoustic signals can be received synchronously to achieve multiple positioning, thereby greatly improving the positioning accuracy.

[0033] In the present application, during radical breast cancer surgery, a tracer is injected intradermally into the areola in advance. Since the tracer has good lymphotropism, it can quickly reach the lymphatic tissue. The composite flexible probe formed by the lead zirconate titanate block 23 and the piezoelectric micro ultrasonic transducer 22 in the present application can dynamically monitor the trajectory of the tracer in the lymphatic vessels in real time. The first stop lymph node reached by the tracer is the sentinel lymph node, and dynamic tracking is achieved to accurately identify and locate the position of the sentinel lymph node.

[0034] In the present application, the probe device 2 is capable of operating within a wider frequency band, can adapt to the detection requirements of different depths and tissues, and supports multiple working modes (such as pulse echo, Doppler, etc.), thereby providing richer diagnostic information, realizing ultrasound / photoacoustic dual-modality positioning of sentinel lymph nodes, and improving the positioning accuracy.

[0035] In the present application, the laser emitter 1 uses a nanosecond pulse laser, and the laser emitter 1 includes a tunable parameter oscillator module, so that the wavelength can be precisely modulated in the near-infrared band through the module, and the pulse light with a pulse width of 5ns and a frequency of 10Hz can be emitted. Preferably, in the present application, the laser wavelength selected by the laser emitter 1 is 780nm, and after coupling of a one-to-two optical fiber bundle, it is irradiated onto the surface of the biological tissue or phantom.

[0036] Preferably, the tracer is nanocarbon.

[0037] Preferably, the ultrasonic unit 221 is hexagonal. By setting the ultrasonic unit 221 to be hexagonal, it can be easily spliced. Of course, in this embodiment, according to actual conditions and specific needs, the shape of the ultrasonic unit 221 can also be set to other shapes, which is not limited here.

[0038] For further information, see Figure 1 As shown, the positioning device also includes a main control unit 3, an amplifying and filtering unit 4, and an imaging unit 5. The main control unit 3 can be used to control the laser transmitter 1 to emit laser light, the amplifying and filtering unit 4 can be used to amplify and filter the photoacoustic signal received by the probe device 2, and transmit the filtered photoacoustic signal to the main control unit 3, and the imaging unit 5 can be connected to the main control unit 3, so that the movement track of the tracer can be displayed. In this way, since the multiple groups of piezoelectric micro-ultrasonic transducers 22 synchronously receive multiple photoacoustic signals, the intensity of the received photoacoustic signal may be weak, and the amplifying and filtering unit 4 can amplify and filter the photoacoustic signal of the probe, so that the quality of the photoacoustic signal is clear and easy to distinguish; then, the filtered photoacoustic signal is transmitted to the main control unit 3, and the main control unit 3 transmits the photoacoustic signal to the imaging unit 5, so that the corresponding tracer track can be displayed.

[0039] Furthermore, the piezoelectric micro ultrasonic transducer 22 is made of silicon-based materials processed by micro-electromechanical systems. In the present application, the micro-electromechanical system is a high-tech device that integrates micro-mechanical and electronic devices, and belongs to the conventional micro-electromechanical system in the prior art, which will not be described here. The piezoelectric micro ultrasonic transducer formed by the micro-electromechanical system is small in size, low in power consumption, and easy to be integrated into portable or minimally invasive medical devices.

[0040] Furthermore, each plurality of groups of piezoelectric micro-ultrasonic transducers 22 track the tracer and satisfy the following relationship:

[0041] R n -R 1 =C(t n -t 1 )

[0042] In the formula, R n is the position of the nth piezoelectric micro-ultrasonic transducer; R 1 is the position of the first piezoelectric micro-ultrasonic transducer, C is the air propagation velocity; t n is the absolute transmission time of the sound source signal to the nth piezoelectric micro-ultrasonic transducer; t 1 is the absolute transmission time from the sound source signal to the first piezoelectric micro-ultrasonic transducer.

[0043] Specifically, in order to better explain the positioning principle of the piezoelectric micro-ultrasonic transducer, in this application, three piezoelectric micro-ultrasonic transducers are used for positioning explanation:

[0044] See also Figure 1 As shown, the position coordinates of the tracer are assumed to be (X, Y); the position coordinates of a single piezoelectric micro-ultrasonic transducer are (X 1 ,0)、(X 2 ,0)、(X 3 ,0), then:

[0045] R 2 -R 1 =C(t 2 -t 1 )=[(X 2 -X) 2 +Y 2 ] 1 / 2 -[(X 1 -X) 2 +Y 2 ] 1 / 2

[0046] R 3 -R 1 =C(t 3 -t1 )=[(X 3 -X) 2 +Y 2 ] 1 / 2 -[(X 1 -X) 2 +Y 2 ] 1 / 2

[0047] By calculating with the above formula, multiple positioning of multiple piezoelectric micro-ultrasonic transducers can be achieved, thereby greatly improving the positioning accuracy.

[0048] For further information, see Figure 2 As shown, the preparation method of the probe device 2 includes the following steps:

[0049] S01: dividing the flexible circuit substrate 21 into a plurality of array elements, and mounting the piezoelectric micro ultrasonic transducer 22 at each array element position of the flexible circuit substrate 21 at 280-350° C.;

[0050] S02: Drilling a hole in the flexible circuit substrate 21, and placing the lead zirconate titanate block 23 in the hole;

[0051] S03: Bond the lead titanate block 23 to the piezoelectric micro ultrasonic transducer 22 through an adhesive.

[0052] In the present application, by selecting a flexible circuit substrate 21, the flexible circuit substrate 21 has a high flexibility, so that it can better adapt to the patient's organs such as breasts and other structures. Specifically, the piezoelectric micro-ultrasonic transducer 22 is electrically connected to the flexible circuit substrate 21 through a metal guide wire; a hole is opened on the flexible circuit substrate 21 to form an accommodating space 222, which is convenient for placing the lead zirconate titanate block 23 in the accommodating space 222, and the lead titanate block 23 is bonded to the piezoelectric micro-ultrasonic transducer 22 by using an adhesive. The ultrasonic transducer 22 is bonded to achieve physical connection to form a composite sensor strip as a whole. By integrating the lead zirconate titanate block 23 and the piezoelectric micro ultrasonic transducer 22 on the flexible circuit substrate 21, the lead zirconate titanate block 23 can provide a larger emission sound pressure to enhance the strength and penetration of the ultrasonic signal, so that the piezoelectric micro ultrasonic transducer 22 can dynamically track the trajectory of the lymph node tracer in the lymphatic vessels, realize dynamic tracking of the entire process, and accurately identify and locate the sentinel lymph node position.

[0053] Furthermore, the step S03 further includes:

[0054] The lead titanate block 23 and the piezoelectric micro ultrasonic transducer 22 bonded by an adhesive are placed in a baking oven at a baking temperature of 50-70° C. for 30 minutes.

[0055] In the present application, the excess water in the adhesive can be dried by baking, thereby preventing the water vapor from adversely affecting the operation of the piezoelectric micro-ultrasonic transducer.

[0056] Finally, it should be noted that the above preferred embodiments are only used to illustrate the technical solutions of the present invention rather than to limit it. Although the present invention has been described in detail through the above preferred embodiments, those skilled in the art should understand that various changes can be made in form and details without departing from the scope defined by the claims of the present invention.

Claims

1. A breast cancer sentinel lymph node positioning device, characterized in that: The invention comprises a laser transmitter, and a probe device which is covered on the laser transmitter and used for tracking a tracer injected into the subcutaneous part of the human areola to generate a photoacoustic signal, and simultaneously receives the photoacoustic signal to realize accurate positioning of the sentinel lymph node. The probe device comprises a flexible circuit substrate, and a plurality of groups of piezoelectric micro-ultrasonic transducers arranged in an array on the flexible circuit substrate. Two adjacent groups of piezoelectric micro-ultrasonic transducers are spliced ​​with each other. Each of the piezoelectric micro-ultrasonic transducers comprises a plurality of ultrasonic units, and each of the ultrasonic units encloses an accommodation space. A lead zirconate titanate block bonded to the ultrasonic unit is built in the accommodation space.

2. A breast cancer sentinel lymph node positioning device according to claim 1, characterized in that: The ultrasonic units are arranged in a hexagonal shape.

3. The breast cancer sentinel lymph node positioning device according to claim 1, characterized in that: It also includes a main control unit for controlling the laser transmitter to emit laser, an amplification and filtering unit for amplifying and filtering the photoacoustic signal received by the probe device and transmitting the filtered photoacoustic signal to the main control unit, and an imaging unit for connecting to the main control unit to display the movement trajectory of the tracer.

4. A breast cancer sentinel lymph node positioning device according to claim 3, characterized in that: The piezoelectric micro ultrasonic transducer is manufactured by processing silicon-based materials using a micro-electromechanical system.

5. The breast cancer sentinel lymph node positioning device according to claim 1, characterized in that: Each of the plurality of groups of piezoelectric micro-ultrasonic transducers tracking tracers satisfies the following relationship: R n -R1=C(t n -t1) In the formula, R n is the position of the nth piezoelectric micro-ultrasonic transducer; R1 is the position of the first piezoelectric micro-ultrasonic transducer, C is the air propagation velocity; t n is the absolute transmission time from the sound source signal to the nth piezoelectric micro-ultrasonic transducer; t1 is the absolute transmission time from the sound source signal to the first piezoelectric micro-ultrasonic transducer.

6. The breast cancer sentinel lymph node positioning device according to claim 1, characterized in that: The preparation method of the probe device comprises the following steps: S01: dividing the flexible circuit substrate into a plurality of array elements, and mounting the piezoelectric micro ultrasonic transducer at each array element position of the flexible circuit substrate at 280-350° C.; S02: opening a hole in the flexible circuit substrate, and placing the lead zirconate titanate block in the hole; S03: Bonding the lead titanate block to the piezoelectric micro ultrasonic transducer through an adhesive.

7. The breast cancer sentinel lymph node positioning device according to claim 6, characterized in that: The step S03 further includes: The lead titanate block and the piezoelectric micro ultrasonic transducer bonded by an adhesive are placed in a baking oven with a baking temperature of 50-70° C. and a baking time of 30 minutes.

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