Integrated ablation device

Abstract

The invention relates to the technical field of medical instruments, and discloses an integrated ablation device which comprises a handheld part and an instrument part. The handheld portion includes an integratable ultrasound probe and an integratable ablation probe. The instrument part comprises an ultrasonic front-end module, an ablation control module and a main control module. The ultrasound front-end module is configured to achieve B-mode imaging and multi-directional blood flow Doppler mode signal generation. The ablation control module is configured to control ablation energy. The main control module transmits and receives multi-angle plane waves or weak focusing wave beams through the ultrasonic front-end module, calculates multi-direction blood flow information of a target tissue according to the received wave beams, and calculates blood supply indexes representing the blood supply active degree according to the multi-direction blood flow information. And controlling the ablation needle to output ablation energy to the target tissue through the ablation control module according to the blood supply index. The ablation parameters can be automatically adjusted according to the blood supply state of the target tissue, excessive ablation or insufficient ablation is effectively avoided, and the safety and effectiveness of treatment are improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an integrated ablation device that combines ultrasound imaging monitoring and energy therapy functions. Background Technology

[0002] The descriptions in this section are intended only to provide background information for the implementation of this application and should not be construed as an admission or implication that they constitute prior art.

[0003] In current clinical practice, minimally invasive treatment has become an important approach for treating nodular lesions within the body. Nodules typically refer to localized pathological masses that form within or on the surface of tissue, differing in texture or density from surrounding normal tissue, and may be palpable or imperceptible. Commonly used minimally invasive treatment methods include radiofrequency ablation, microwave ablation, or chemical ablation. These methods usually utilize ultrasound imaging equipment for pre-treatment localization and for observation and identification of the treatment target during or after treatment.

[0004] While the aforementioned ablation protocols have solved many clinical problems, several challenges remain. During treatment, although the approximate location of the needle can be observed through ultrasound or other imaging, the actual treatment area (i.e., coagulation area) resulting from energy propagation is difficult to predict precisely. This is primarily because energy propagation within tissue largely depends on tissue structure and vascular distribution. Blood flow in blood vessels carries away heat, creating a "heat sink effect," which significantly impacts ablation efficacy. Studies have shown that tumors near large blood vessels (typically larger than 3 mm in diameter) have a higher local recurrence rate, and approximately one-third of ablation treatments exhibit distorted vascular margins. Due to individual differences in vascular distribution, the ablation coagulation area varies significantly between different tumors.

[0005] Currently, clinical judgments regarding the coagulation range and safety boundaries, or the estimated ablation intensity (power) and time, typically rely on physicians' empirical criteria and static size predictions. This reliance on subjective judgment and speculation lacks quantitative, objective evaluation criteria, which may affect treatment outcomes and even lead to safety issues. For example, incomplete ablation due to the heat sink effect may cause recurrence; excessive ablation to ensure boundaries may damage surrounding sensitive tissues.

[0006] Ultrasound is the primary imaging tool for assessing the treatment status of nodules during surgery, often combined with color and pulsed Doppler techniques. Doppler ultrasound utilizes the Doppler effect to detect hemodynamic information, which can be used to assess the blood supply status and blood flow patterns of nodules. For example, typical malignant nodules generally have significant peripheral blood flow. However, existing Doppler imaging methods for observing the ablation process have significant limitations: traditional color Doppler ultrasound beams generally use a fixed transmit and receive angle, and doctors can only observe the projection of blood velocity relative to a fixed direction (i.e., the component usually distinguished by red and blue on the color Doppler screen). This method cannot monitor blood flow perpendicular or nearly perpendicular to this fixed direction and ignores the amplitude of blood flow velocity deviating from this fixed direction, resulting in the actual monitoring of blood flow velocity in a single direction, which cannot comprehensively reflect the complex vascular network blood supply situation. Current ultrasound imaging systems lack specific quantitative monitoring indicators for treatment status (such as changes in blood supply activity) and also lack effective means to automatically control treatment parameters based on real-time monitoring results. Summary of the Invention

[0007] This application provides an integrated ablation device that solves the following problems: In existing ablation treatments, due to the lack of objective and quantitative real-time monitoring indicators and the blind spots in traditional blood flow imaging, the determination of the treatment endpoint relies on the doctor's subjective experience, making it difficult to accurately balance the thoroughness and safety of the treatment.

[0008] This application discloses an integrated ablation device, including a handheld part and an instrument part. The handheld component includes an integrable ultrasound probe and an integrable ablation probe, which are combined into one unit during use via a detachable snap-fit ​​mechanism. The integrable ultrasound probe includes an ultrasound rod and an ultrasound transducer. The integrable ablation probe includes an ablation needle guide tube, a push-needle mechanism, and an ablation needle. After the snap-fit ​​mechanism is engaged, the ultrasound rod and the ablation needle guide tube maintain the same direction, are on the same plane, and are in a fixed relative position. The push-needle mechanism is used to push out or retract the ablation needle. The instrument comprises: an ultrasound front-end module, an ablation control module, and a main control module; the ultrasound front-end module is configured to realize B-mode imaging and multi-directional blood flow Doppler signal generation; the ablation control module is configured to control the ablation energy supplied to the ablation needle; the main control module includes a beam control unit, a signal processing unit, and a control unit; the beam control unit is configured to transmit and receive multi-angle plane waves or weakly focused beams through the ultrasound front-end module; the signal processing unit is configured to calculate multi-directional blood flow information of the target tissue based on the received beams, and calculate blood supply indicators characterizing the degree of blood supply activity based on the multi-directional blood flow information; the control unit is configured to compare the blood supply indicators with a preset threshold, and control the ablation energy output by the ablation needle to the target tissue through the ablation control module based on the comparison result.

[0009] In a preferred embodiment, the signal processing unit is configured as follows: Obtain multi-directional blood flow velocity components at various locations within the target tissue; The blood flow velocity components at each location are weighted and calculated to obtain the blood supply index.

[0010] In a preferred embodiment, the signal processing unit is configured to calculate the blood supply index in the following manner: Blood supply index = ; in, and These represent the components of blood flow velocity at each location in two directions. The weighting factor is the weighting factor for the nth position, where m is the total number of positions. The weighting factor is a function related to the distance of the position relative to the center of the target tissue, and the weighting factor decreases as the distance increases.

[0011] In a preferred embodiment, the integrable ablation probe further includes an adjustable limiter for limiting the upper limit of the ablation needle extension; the limiting position of the adjustable limiter on the ablation needle is calculated by the main control module based on the relative positions of the target ablation point, the ablation needle guide tube, and the ultrasonic transducer.

[0012] In a preferred embodiment, the integrable ultrasonic probe further includes an ultrasonic pitch angle control mechanism for adjusting the pitch angle of the ultrasonic transducer relative to the ablation needle guide tube, and sending the pitch angle information to the main control module for calculating the limiting position of the adjustable limiter on the ablation needle; the relative position of the ablation needle guide tube and the ultrasonic transducer includes the pitch angle information. In a preferred embodiment, the signal processing unit is configured to calculate the blood supply index in the following manner: Identify blood vessels perpendicular to the imaging plane based on the grayscale features of ultrasound images; The cross-sectional area of ​​the blood vessel is continuously monitored during one cardiac cycle; Calculate the difference ΔS between the maximum and minimum values ​​of the cross-sectional area during the cardiac cycle; Calculate blood supply indicators = ; in, and These are the maximum values ​​of the blood flow velocity components at each location during the cardiac cycle in the mutually perpendicular x and y directions. The weighting factor is a function of the distance of the location relative to the center of the target tissue, and the weighting factor decreases as the distance increases.

[0013] In a preferred embodiment, the signal processing unit is configured to calculate the ΔS in the following manner: Periodically count the pixels in the target image region whose gray values ​​are less than a preset gray threshold to form a time series of pixel counts; The time series is subjected to bandpass filtering, and the passing frequency range of the bandpass filter corresponds to the range of normal heart rate. For the time series after the bandpass filter, the root mean square value within a sliding window of a predetermined length is calculated as ΔS.

[0014] In a preferred embodiment, the ultrasonic transducer is configured to emit plane waves or weakly focused beams at multiple angles between 25° and 45° between the angle between the transducer and the needle body and receive echo signals. The signal processing unit is configured to perform software beamforming on the echo signal and enhance the needle imaging according to the Frangi filter needle imaging index S.

[0015] In a preferred embodiment, the signal processing unit is further configured to: The target area of ​​the target organization and the surrounding area outside the target area are determined respectively; Calculate the first blood supply index of the target area and the second blood supply index of the surrounding area, respectively. The control unit is configured to compare the first blood supply index with the first threshold, compare the second blood supply index with the second threshold, and control the ablation energy output by the ablation needle to the target tissue through the ablation control module according to the comparison results.

[0016] In a preferred embodiment, the first threshold is 10% to 20% of the initial blood supply index of the target area, and the second threshold is 80% to 90% of the initial blood supply index of the surrounding area.

[0017] In the embodiments of this application, by adopting a co-directional integrated design including a detachable snap-fit ​​mechanism and a closed-loop control strategy based on software beamforming, the ultrasound imaging unit and the ablation treatment unit are mechanically constrained to be coplanar and have fixed relative positions. Multi-angle plane wave or weak focused beam imaging technology is used to acquire multi-directional blood flow information of the target area in real time to construct a quantitative blood supply activity index. This index is used as a feedback signal and compared with a preset threshold to automatically adjust the ablation energy output. This can effectively solve the problem of positioning difficulties caused by the non-fixed spatial relationship between the imaging and treatment devices in the prior art. At the same time, it overcomes the shortcomings of traditional Doppler imaging, which can only monitor blood flow in a single direction and completely rely on the doctor's subjective experience to judge the ablation endpoint. It realizes real-time, objective, and quantitative monitoring of the ablation process, and significantly improves the accuracy, effectiveness, and safety of nodule ablation treatment.

[0018] Furthermore, by acquiring and weighting the multi-directional blood flow velocity components at various locations within the target tissue, the high frame rate characteristics of plane wave imaging can be used to capture instantaneous multi-directional Doppler signals. Vector synthesis can then be used to accurately calculate the true blood flow velocity in the two-dimensional plane, thereby eliminating the velocity estimation error caused by the different angles between the blood flow direction and the sound beam in traditional color Doppler imaging, and providing more accurate blood supply status assessment data.

[0019] Furthermore, by introducing a weighted factor related to the distance from the center of the target tissue to calculate blood supply indicators, the monitoring focus can be placed on the core area of ​​the nodule. This can effectively avoid the impact of irregular nodule edges or blood flow interference from surrounding normal tissue on the assessment of the degree of ablation of the lesion core, ensuring that treatment decisions are mainly based on the blood supply blockage of the lesion body, thereby improving the clinical relevance and accuracy of judging the ablation endpoint.

[0020] Furthermore, by setting a push-needle mechanism to control the extension or retraction of the ablation needle, and specifying the needle application limit based on the application point set by image feedback, and by adjusting the adjustable limiter to limit the extension position, the ablation needle can be stored in the guide tube during the instrument intervention and positioning stages to protect the needle tip and avoid damage to the tissue along the way. After precise ultrasound positioning, the ablation needle can be smoothly delivered to the target point, enhancing the convenience and safety of the surgical operation.

[0021] Furthermore, by setting an ultrasound pitch control mechanism on the integrable ultrasound probe, the imaging angle of the ultrasound transducer can be finely adjusted while keeping the handle position relatively stable. This allows for flexible search of the optimal section to cover the target nodule and the pre-placed needle path, ensuring that the puncture trajectory is always within the ultrasound imaging plane, greatly simplifying the doctor's positioning operation in complex anatomical environments.

[0022] Furthermore, by combining the grayscale features of ultrasound images to identify changes in the cross-sectional area of ​​blood vessels perpendicular to the imaging plane, the area difference during the cardiac cycle is calculated. By incorporating this into the calculation of blood supply indicators, the radial motion characteristics of blood vessels can be used to characterize the blood flow component perpendicular to the two-dimensional imaging plane, thereby making up for the blind spot of two-dimensional Doppler imaging in detecting vertical blood flow and realizing a more comprehensive and rigorous assessment of the overall blood supply status of the target tissue in three-dimensional space.

[0023] Furthermore, a time series is formed by counting low-grayscale pixels, and the determination is made by combining bandpass filtering and root mean square value calculation within the heart rate frequency range. It can transform the detection of complex changes in blood vessel cross sections into a signal processing problem based on gray-scale statistics. It can effectively filter out low-frequency interference and high-frequency noise caused by respiratory movements or hand tremors, extract blood vessel pulsation signals that specifically reflect the heartbeat cycle, and improve the robustness and computational efficiency of vertical blood flow monitoring.

[0024] Furthermore, by emitting a beam at a specific angle (25°–45°) to the needle body and processing the echo signal using the Frangi filtering algorithm, the physical characteristics of the needle body generating strong reflection (high echo band) within this angle range and the geometric features of the linear structure can be utilized to significantly enhance the imaging contrast and clarity of the needle body in complex tissue backgrounds. This helps doctors clearly identify the needle tip position and insertion depth, thereby reducing puncture risks.

[0025] Furthermore, by separately delineating the target area and the surrounding area and setting independent blood supply indicator thresholds for dual monitoring, it is possible to ensure that the blood supply indicators inside the target lesion are reduced to extremely low levels (ensuring thorough ablation) while monitoring the blood supply indicators in the surrounding area to maintain a high level (preventing over-ablation). This allows for the establishment of a quantified safety boundary between completely destroying tumor tissue and protecting surrounding vital organs or blood vessels, minimizing complications.

[0026] The various technical features disclosed in the above-described invention, the various technical features disclosed in the following embodiments and examples, and the various technical features disclosed in the accompanying drawings can be freely combined to form various new technical solutions (all of which should be considered as having been recorded in this specification), unless such a combination of technical features is technically infeasible. For example, in one example, feature A+B+C is disclosed, and in another example, feature A+B+D+E is disclosed. Features C and D are equivalent technical means that serve the same function, and technically only one needs to be used; it is impossible to use both simultaneously. Feature E can be technically combined with feature C. Therefore, the solution A+B+C+D should not be considered as having been recorded because it is technically infeasible, while the solution A+B+C+E should be considered as having been recorded. Attached Figure Description

[0027] Figure 1 is a schematic diagram of the structure of an integrated ablation device handle according to an embodiment of this application. Figure 1A A 3D view of an integrated ultrasonic probe. Figure 1B This is a side view of the handle before integration and assembly. The markings in the figure are: 2-lower housing, 3-adjustable limiter, 4-ablation needle guide tube, 5-ultrasonic rod, 6-ultrasonic pitch angle adjustment lever, 7-upper housing, 8-pusher rod.

[0028] Figure 2 is a schematic diagram of the end of an integrated ablation device according to an embodiment of this application. Figure 2A This is a top view of the end of the ultrasonic probe that can be integrated before assembly, where 11 is a pitch and rotation joint with a soft waterproof seal, 12 is an ultrasonic transducer (linear array probe), 13 is a bayonet for fixing the guide tube, and 14 is a positioning groove for placing the fixed guide tube. Figure 2B This is a top view of the assembled rear end, where 16 is the ablation needle guide tube and 17 is the ablation needle.

[0029] Figure 3 This is a schematic diagram of the end of an integrated ablation device employing an arc array ultrasonic probe according to an embodiment of this application.

[0030] Figure 4 This is a schematic diagram of ultrasound imaging-guided needle insertion into a nodule according to one embodiment of this application. The figure shows an ultrasound beam emitted by an ultrasound transducer covering the target nodule area, and an ablation needle 17 extending from a guide tube 16 and inserting into the center of the nodule along a predetermined trajectory.

[0031] Figure 5 is a schematic diagram of multi-directional blood flow imaging and vascular monitoring according to an embodiment of this application. Figure 5A This is a map showing the blood flow vector distribution as displayed by multi-directional Doppler imaging. Figure 5B This is a schematic diagram of a blood vessel cross-section perpendicular to the imaging plane, where 29 represents a vertical blood vessel. Figure 5C The original curve showing how the pixel count changes over time. Figure 5D The curve is the ΔS time series curve after bandpass filtering.

[0032] Figure 6 is a schematic diagram illustrating the plane wave imaging principle according to an embodiment of this application. Figure 6A This is a schematic diagram of a plane wave emission at an angle of 0°, where the excitation pulse arrives at all cells in the array simultaneously. Figure 6B This is a schematic diagram of a plane wave emission with a certain tilt angle. The tilted wavefront is generated by controlling the excitation delay of each unit.

[0033] Figure 7This is a schematic diagram of the time sequence of excitation pulses according to an embodiment of this application. In the figure, 21 represents a group of pulses, composed of plane wave excitation pulses at different angles. 22 represents an excitation pulse with an angle of +10°, and 23 represents an excitation pulse with an angle of -10°. 24 represents the pulse repetition time between adjacent pulse groups.

[0034] Figure 8 This is an overall connection block diagram of an integrated ablation device according to an embodiment of this application. The figure shows the connection relationship between the handheld part 100 and the instrument part 200. The instrument part 200 includes an ultrasound front-end module 30, an ablation control module 31, a main control module 32, and a display 33. The ultrasound probe is connected to the ultrasound front-end module 30, and the main control module 32 is connected to the ultrasound front-end module 30, the ablation control module 31, and the display 33.

[0035] Figure 9 The diagram shows the Tukey window function when α=0.5.

[0036] Figure 10 The curve is an S-Curve function. Detailed Implementation

[0037] In the following description, many technical details are presented to help the reader better understand this application. However, those skilled in the art will understand that the technical solutions claimed in this application can be implemented even without these technical details and various variations and modifications based on the following embodiments.

[0038] Explanation of some concepts: Ablation: A method of achieving therapeutic effects by denaturing tissue proteins through physical or chemical means.

[0039] Nodules: refers to localized, solid, round or oval pathological masses that form inside or on the surface of tissues and differ in texture or density from the surrounding normal tissues. They may be palpable or intangible.

[0040] Blood supply indicators: factors that assess the activity of blood supply to tissues; the higher the blood supply indicator, the more active the blood supply.

[0041] Example 1 This embodiment provides an integrated ablation device with a handheld component 100 and an instrument component, which work together to achieve ablation treatment and real-time monitoring of target tissue. Figure 8 As shown, the handheld part 100 is connected to the instrument part 200 via a cable. The instrument part 200 includes an ultrasound front-end module 30, an ablation control module 31, a main control module 32, and a display 33.

[0042] As shown in Figure 1, the handheld part 100 consists of two components: an integrable ultrasound probe and an integrable ablation probe. Figure 1A A three-dimensional structure that can integrate an ultrasonic probe is shown. Figure 1B A side view of the integrated, assembled handle is shown. The integrateable ultrasonic probe includes an ultrasonic rod 5 and an ultrasonic transducer 12 disposed at the distal end of the ultrasonic rod. In this embodiment, the ultrasonic transducer is in the form of a linear array probe, such as... Figure 2A As indicated by mark 12, this linear array probe consists of 96-128 piezoelectric crystal units arranged in a straight line, with a unit spacing of 0.2 mm and a center frequency of 7.5 MHz. The integrated ablation probe includes an ablation needle guide tube 4 and an ablation needle that can slide within the guide tube. The ablation needle can be a radiofrequency ablation needle or a microwave ablation needle, with the radiofrequency ablation needle operating at a frequency of 460 kHz and the microwave ablation needle operating at a frequency of 2450 MHz.

[0043] As shown in Figure 2, an integrated ultrasound probe and an integrated ablation probe are combined into one unit via a detachable snap-fit ​​mechanism. Specifically, as... Figure 2A As shown, the locking mechanism includes a locking groove 13 and a positioning groove 14 disposed on the distal side of the ultrasonic probe, and a protruding structure disposed on the ablation needle guide tube that mates with the locking groove and the positioning groove. The locking groove 13 has a depth of 2 mm to 4 mm and a width of 3 mm to 5 mm, and the positioning groove 14 extends along the axial direction of the ultrasonic probe with a length of 15 mm to 25 mm. When the protruding structure that can integrate the ablation probe is inserted into the locking groove 13 and slides into place along the positioning groove 14, the two components achieve a rigid connection, and the assembled end structure is as follows. Figure 2B As shown, 16 is the ablation needle guide tube, and 17 is the ablation needle. Furthermore, as... Figure 1B As shown, an upper housing 7 and a lower housing 2 are also provided at the proximal end of the handheld part. A bayonet structure is also provided between the upper housing 7 and the lower housing 2 for fixing the two components at the proximal end. Through the double fixing of the distal end slot and the proximal housing bayonet, after the locking mechanism is engaged, the ultrasonic rod 5 and the ablation needle guide tube 4 maintain a coplanar and fixed relative position, thereby ensuring that the ablation needle's application trajectory is always within the ultrasonic imaging plane.

[0044] In addition to linear array probes, the ultrasonic transducer in this application embodiment can also be in the form of an arc array probe, such as... Figure 3 As shown, the only difference lies in the shape of the imaging plane and the imaging quality of a specific area.

[0045] like Figure 8As shown, the instrument section 200 includes an ultrasound front-end module 30, an ablation control module 31, and a main control module 32. The ultrasound front-end module 30 includes a transmitting circuit, a receiving circuit, and corresponding control logic circuits. The transmitting circuit generates electrical pulse signals to excite the ultrasound transducer, and the receiving circuit amplifies and performs analog-to-digital conversion on the echo signals received by the ultrasound transducer. The ablation control module 31 controls the ablation energy (or ablation power) of the ablation needle 17. The main control module 32 includes a beam control unit, a signal processing unit, and a control unit. The beam control unit can be implemented using an FPGA, the signal processing unit can be implemented using a GPU or a high-performance CPU, and the control unit can be implemented using an embedded processor. In another embodiment, any two or all of the beam control unit, signal processing unit, and control unit can be integrated into a single processor. The main control module 32 is configured to generate B-mode imaging and multi-directional blood flow Doppler signals. B-mode imaging is used to display the anatomical structure of the target tissue, and multi-directional blood flow Doppler signals are used to acquire blood flow information within the target tissue. The main control module 32 is then connected to the display 33 to present ultrasound images and treatment parameters to the doctor.

[0046] As shown in Figure 6, the beam control unit is configured to transmit and receive multi-angle plane waves or weakly focused beams through the ultrasonic front-end module 30. Figure 6A The diagram shows the plane wave emission at an angle of 0°, where the excitation pulse arrives at all units in the array simultaneously, and the emitted sound wave forms a wavefront parallel to the probe surface. Figure 6B The diagram illustrates the transmission of plane waves at a certain tilt angle. By controlling the time delay of the excitation pulses arriving at each element in the linear array probe, plane waves with different tilt angles can be generated. In one specific implementation, the beam control unit controls the transmitting circuit to generate a family of pulses containing multiple plane wave excitation pulses at different angles, such as eight plane waves with angles of +10°, -10°, +20°, -20°, +30°, -30°, +40°, and -40°. The delay of the i-th element is... / c, where pitch is the unit spacing, θ is the plane wave tilt angle, and c is the speed of sound (approximately 1540 m / s).

[0047] In another specific implementation, it can also be derived from an arc array (such as...) Figure 3 It emits plane waves with variable angles. The arc array is generally designed to be arranged around an arc formed by a certain center and radius R, forming a sector. Mathematically, to generate arc waves with variable emission angles, it can be considered that the initial sector rotates around the outermost element. The angle, the new position obtained, is used to calculate the additional delay. Assume the original probe's arc radius is R, and the center is C = (0, 0). After rotation, the center coordinates are C = (Rtanθ, RSecθ). Calculations show that to generate an angle of... The additional delay on each element of the arc wave can be expressed by the following formula: Among the angles This is the relative angle between this unit and the first unit in the sector; for each unit in a fixed ultrasonic probe, this is a constant. Only simple logic needs to be stored in the logic circuitry near the transmitting circuit. A range of coS values ​​can be easily used to generate any... An angular curved wave.

[0048] The signal processing unit is configured to calculate multi-directional blood flow information of the target tissue based on the received beam, and to calculate blood supply indicators characterizing the degree of blood supply activity based on the multi-directional blood flow information. For example... Figure 5A As shown, the signal processing unit performs software beamforming on the echo signals of plane waves at various angles. Through Hilbert transform and fundamental wave demodulation, it obtains the IQ signal at each point within the imaging plane. Then, it calculates the blood flow velocity component at each point based on the relative phase shift reflected by the IQ signals within a fixed time interval. By vector combining the blood flow velocity components obtained from each angle, the signal is obtained as shown in the diagram. Figure 5A The diagram shows the multi-directional blood flow velocity vector distribution at various locations within a two-dimensional plane. The signal processing unit further performs weighted calculations on the blood flow velocity components at each location to obtain blood supply indicators characterizing the degree of blood supply activity.

[0049] like Figure 8 As shown, the control unit is configured to compare the blood supply index with a preset threshold, and control the ablation energy output by the ablation needle 17 to the target tissue through the ablation control module 31 based on the comparison result. When the blood supply index is higher than the preset threshold, the ablation control module 31 maintains or increases the ablation energy output; when the blood supply index is lower than the preset threshold, the ablation control module 31 reduces the ablation energy output or stops ablation. Through the above closed-loop control mechanism, the integrated ablation device of this embodiment can automatically adjust the ablation parameters according to the real-time blood supply status of the target tissue, avoiding over-ablation or under-ablation.

[0050] like Figure 4 As shown, during use, the doctor first assembles the integrated ultrasound probe and the integrated ablation probe into one unit using a snap-fit ​​mechanism. Then, the distal end of the handheld part is inserted through a natural body cavity or surgical opening to approach the target organ. The instrument reads B-mode images from the ultrasound probe to locate the target nodule. The doctor outlines the nodule based on the ultrasound image on the user interface and adjusts the position of the handheld part so that the center of the needle insertion coincides with the center of the nodule. Figure 4The diagram illustrates the process where an ultrasound beam emitted by an ultrasound transducer covers the target nodule area, and an ablation needle 17 extends from the guide tube 16 and pierces the center of the nodule along a predetermined trajectory. The instrument then enters plane wave imaging mode to image the blood flow within and around the nodule, calculating the initial blood supply parameters within the delineated contour. After the physician sets the threshold for the blood supply parameters, ablation treatment begins according to the calculated treatment parameters. The instrument continuously monitors the blood supply parameters during treatment and controls the ablation energy accordingly.

[0051] Example 2 Based on Example 1, this embodiment elaborates in detail the principle of multi-directional blood flow imaging and the specific calculation method of blood supply indicators.

[0052] This embodiment employs a software beamforming-based ultra-high-speed plane wave imaging method to achieve multi-directional blood flow monitoring. As shown in Figure 6, unlike traditional color Doppler which uses fixed transmission and reception angles, the plane wave imaging method transmits plane waves at multiple angles and performs software beamforming on the echo signals, enabling it to capture Doppler signals from multiple directions instantaneously. Since plane wave imaging does not depend on the scanning process of the focusing beam, its imaging frame rate is limited only by the round-trip speed of the sound waves, theoretically reaching thousands of frames per second. In this embodiment, the imaging frame rate is set to 3000 frames per second.

[0053] like Figure 7 As shown, the beam control unit controls the transmitting circuit of the ultrasound front-end module to generate an excitation pulse time sequence. This time sequence consists of multiple pulse families. Mark 21 in the figure represents one pulse family, composed of plane wave excitation pulses at different angles. Each pulse family contains eight plane wave excitation pulses at different angles: +10°, -10°, +20°, -20°, +30°, -30°, +40°, and -40°. Mark 22 represents the excitation pulse at +10°, and Mark 23 represents the excitation pulse at -10°. The interval between adjacent pulses within the same pulse family is very short, approximately 10 μS to 50 μS; the pulse repetition time 24 between adjacent pulse families is relatively long, approximately 200 μS to 500 μS.

[0054] The signal processing unit acquires multi-directional blood flow velocity components at various locations within the target tissue. Specifically, for each plane wave at a given angle, the echo signal received by the linear array probe is amplified and converted from analog to digital. The signal processing unit first performs software beamforming, using either a time-domain delay addition method or a frequency-domain calculation method to convert the raw radio frequency data into IQ signals for each point within the imaging plane. Then, the IQ signals of plane waves at the same angle between adjacent pulse groups are compared, and the results are processed according to... Figure 7 The relative phase shift reflected by the IQ signal during the fixed time interval of 24, as shown, is used to calculate the blood flow velocity component in that angular direction. Let the blood flow velocity component at a certain position in the θ angular direction be v. θThen the blood flow velocity at that location in the two-dimensional plane can be decomposed into a horizontal component. and vertical component The two are obtained by vector synthesis of velocity components in various angular directions, forming a structure like... Figure 5A The diagram shows the blood flow vector distribution.

[0055] The signal processing unit performs weighted calculations on the blood flow velocity components at each location to obtain the blood supply index. The formula for calculating the blood supply index is: Blood Supply Index = ,in, and denoted as the horizontal and vertical components of the blood flow velocity at the nth position, respectively, where m is the total number of positions involved in the calculation. The weighting factor is the weighting factor for the nth position. This weighting factor is a function of the distance of that position relative to the center of the target tissue, and it decreases as the distance increases.

[0056] In one specific implementation, the weighting factor Using the reciprocal distance function: Where (x, y) are the coordinates of the location relative to the center of the target tissue, and k is a constant coefficient that can be adjusted according to the size of the target tissue, for example, k can take values ​​from 0.1 to 1.0. A weighting factor based on the inverse distance function is used, giving higher weight to locations closer to the center of the target tissue, which aligns with the clinical need to pay more attention to the blood supply to the central part of the nodule.

[0057] In another specific implementation, the weighting factor The Tukey window function is used to achieve a flat weight distribution in the central region and a smooth weight transition in the edge region. The Tukey window function is defined as a piecewise function: Where r is the normalized distance (the ratio of the distance from this location to the center to the radius of the target tissue), and α is a parameter controlling the edge width, ranging from 0.3 to 0.7, preferably 0.5. The Tukey window function with α=0.5 is as follows: Figure 9 As shown, the horizontal axis of the graph represents the sample index, and the vertical axis represents the amplitude.

[0058] In yet another specific implementation, the weighting factor The S-Curve function can be used to obtain smoother transition characteristics and ensure first-order and second-order continuity. The basic S-Curve function is defined as follows: Its curve is as follows Figure 10 As shown. Figure 10 The horizontal axis is t, and the vertical axis is S(t).

[0059] The S-Curve function also includes variations such as S(t) = 6t. 5 -15t 4 +10t 3 By substituting the normalized distance r into the S-Curve function and taking the complement, we can obtain the weighting factor that smoothly decays from the center to the edge.

[0060] In yet another specific implementation, the weighting factor Alternatively, the following function can be used to achieve a higher weight in the central region and a smooth transition with a lower weight from the edges to the far reaches. Using the weighted calculation method described above, the blood supply index can comprehensively reflect the blood flow activity at various locations within the target tissue, and is more sensitive to changes in blood supply in the central region. During ablation therapy, as the target tissue is ablated, its blood supply gradually decreases, and the blood supply index also declines accordingly. The control unit monitors the changing trends of the blood supply index to achieve real-time assessment and control of the ablation process.

[0061] Example 3 Based on Embodiment 1, this embodiment elaborates on the mechanical control mechanism of the handheld part, including the needle pushing mechanism and the ultrasonic pitch angle control mechanism.

[0062] like Figure 1B As shown, the integrated ablation probe also includes a needle-pushing mechanism for pushing or retracting the ablation needle. Specifically, the needle-pushing mechanism includes a needle-pushing rod 8 disposed within the handle, a needle-pushing slider connected to the needle-pushing rod 8, and a needle-pushing operating part disposed on the outer surface of the handle. The needle-pushing rod 8 extends axially along the ablation needle guide tube 4, with its distal end abutting against the proximal end of the ablation needle, and its proximal end being fixedly connected to the needle-pushing slider. The needle-pushing slider is disposed in a guide rail inside the handle and can slide back and forth along the guide rail. The needle-pushing operating part is a lever or button disposed on the side of the handle and is connected to the needle-pushing slider via a linkage or gear mechanism. When the doctor operates the needle-pushing operating part, the needle-pushing slider moves along the guide rail, causing the needle-pushing rod 8 to push or retract the ablation needle.

[0063] To precisely control the needle insertion depth during surgery, the needle pushing mechanism also includes a needle insertion endpoint limiting mechanism. This limiting mechanism includes a graduated scale on a guide rail and an adjustable stop block. The graduated scale indicates the length of the ablation needle extending from the guide tube outlet, with graduations of 1 mm. The stop block slides on the guide rail and is fixed in the desired position by screws or clips. It stops moving when the needle pushing slider contacts the stop block, thus limiting the maximum extension length of the ablation needle. Figure 4 As shown, before the operation, the doctor sets the limiting block in the corresponding position according to the depth of the nodule measured by the ultrasound image, which can ensure the precise control of the needle depth and make the ablation needle 17 accurately reach the center of the target nodule.

[0064] As shown in Figures 1 and 2, the integrable ultrasonic probe also includes an ultrasonic pitch angle control mechanism for adjusting the pitch angle of the ultrasonic transducer. The ultrasonic pitch angle control mechanism includes a pitch rotation joint 11 located at the distal end of the ultrasonic boom 5 and an adjusting lever 6 located on the handle. Figure 2A As shown, the pitch rotation joint 11 adopts a hinge structure with a soft, waterproof seal, and its rotation axis is perpendicular to the axis of the ultrasonic rod 5 and the imaging plane. The ultrasonic transducer 12 is mounted on one side of the pitch rotation joint 11 and can rotate around the rotation axis within a certain angle range, which is -30° to +30°.

[0065] like Figure 1B As shown, the adjusting lever 6 is located on the outer surface of the upper housing 7 of the handle and is connected to the pitch rotation joint 11 via a steel wire rope or push-pull rod. When the doctor pushes the adjusting lever 6 back and forth, the steel wire rope or push-pull rod drives the pitch rotation joint 11 to rotate, thereby adjusting the pitch angle of the ultrasound transducer 12. The amount of movement of the adjusting lever 6 is proportional to the change in pitch angle; a 10mm movement of the adjusting lever 6 corresponds to a pitch angle change of approximately 10°. The adjusting lever 6 may also be provided with positioning grooves, allowing the doctor to fix the adjusting lever 6 in several preset positions, such as 0°, ±15°, ±30°, etc.

[0066] The design of the ultrasound pitch control mechanism allows surgeons to easily adjust the direction of the ultrasound imaging field of view during surgery. For example... Figure 4 As shown, when locating the target nodule, the doctor can adjust the pitch angle to position the target nodule in the central region of the ultrasound image, thereby obtaining better imaging quality. Before needle insertion, the doctor adjusts the pitch angle to expose the outlet of the ablation needle guide tube 16 and aligns the target needle insertion center with the center of the target nodule. Because the locking mechanism ensures the coplanar relationship between the ultrasound rod 5 and the ablation needle guide tube 4, the insertion trajectory of the ablation needle 17 remains within the ultrasound imaging plane after adjusting the pitch angle, allowing the doctor to observe the advancement path of the ablation needle 17 in real time on the ultrasound image.

[0067] A specific surgical procedure example is as follows: 1. The handheld part of the device is assembled and integrated together by the bayonet 13 at the distal end and the bayonet in the upper and lower housings 2 and 7 at the proximal end.

[0068] 2. Insert the distal end of the handheld part of the instrument into the human body through a natural cavity or surgical opening. The instrument part reads the conventional B-mode image from the ultrasound probe to locate the target nodule. If necessary, adjust the pitch angle of the probe end with the adjusting lever 6.

[0069] 3. On the user interface of the instrument section of this device, the outline of the nodule is drawn based on the ultrasound image.

[0070] 4. Adjust the position of the adjusting lever 6 and observe it on the user interface of the instrument to make the target acupuncture center and the nodule center overlap.

[0071] 5. The instrument performs preliminary calculations of treatment power and time based on the outline drawn in step 3 and the center determined in step 4.

[0072] 6. The instrument enters plane wave imaging mode, which generates a plane vector distribution map of blood flow in and around the nodule, and calculates the blood supply index A inside the outline.

[0073] 7. The doctor continues to outline key blood flow areas outside the nodule contour on the user interface, and the instrument calculates blood supply index B for these areas.

[0074] 8. Set a relative value for the blood supply index A within the contour, such as 10% or 20%, or set an absolute value for it, as a treatment threshold. If the blood supply falls below this threshold, treatment will be stopped.

[0075] 9. Set a relative value for the extracorporeal blood supply index B, such as 80% or 90%, or set an absolute value for it, as a treatment threshold. If the value is lower than this threshold, treatment should be stopped.

[0076] 10. Begin ablation treatment based on the treatment parameters set in step 5, while also being constrained by the settings in steps 8 and 9.

[0077] Example 4 This embodiment, based on Embodiment 1 and Embodiment 2, further expands the calculation method of blood supply indicators by introducing the monitoring of blood vessels perpendicular to the imaging plane.

[0078] like Figure 5A As shown, the multi-directional blood flow imaging method described in Embodiment 2 can acquire blood flow velocity components in each direction within the imaging plane, but blood flow perpendicular to the imaging plane cannot be directly measured. Figure 5B As shown, label 29 represents a blood vessel perpendicular to the imaging plane, which appears as a circular or elliptical cross-section on the imaging plane. To more comprehensively assess the blood supply to the target tissue, this embodiment proposes a method for monitoring radial motion of blood vessels based on the cardiac cycle. This method indirectly reflects the blood flow by monitoring the changes in the cross-sectional area of ​​the blood vessel 29 perpendicular to the imaging plane during the cardiac cycle.

[0079] The signal processing unit is configured to calculate blood supply parameters as follows: First, it identifies blood vessels 29 perpendicular to the imaging plane based on the grayscale features of the ultrasound image. In B-mode ultrasound images, the lumen of a blood vessel is a hypoechoic region, exhibiting a lower grayscale value, while the vessel wall and surrounding tissue are of medium or high echogenicity, exhibiting a higher grayscale value. The signal processing unit identifies the cross-sectional contours of blood vessels 29 perpendicular to the imaging plane in the image using an automatic image segmentation algorithm or by accepting manual annotations from a physician. The automatic image segmentation algorithm may employ a region growing method based on grayscale thresholding or a semantic segmentation network based on deep learning.

[0080] The signal processing unit then continuously monitors the cross-sectional area of ​​the blood vessel 29 within one cardiac cycle. The length of the cardiac cycle is approximately 0.6 to 1.2 seconds, corresponding to a heart rate of 50 to 100 bpm. At an ultrasound imaging frame rate of 30 fps, 18 to 36 frames can be acquired within one cardiac cycle. For each frame, the signal processing unit calculates the area of ​​the identified blood vessel cross-section, forming a sequence of cross-sectional area changes over time. Due to the periodic pulsation of the heart, the cross-sectional area of ​​the artery differs between systole and diastole; monitoring this difference reflects the level of blood flow activity within the vessel.

[0081] The signal processing unit calculates the difference ΔS between the maximum and minimum values ​​of the cross-sectional area during the cardiac cycle. To improve the accuracy and reliability of the measurement, this embodiment employs the following processing method. First, pixels with gray values ​​less than a preset gray threshold within the target image region are periodically counted, forming a time series of pixel counts. The preset gray threshold ranges from 20 to 60 (based on 256 gray levels) and can be adjusted according to the actual image quality. The pixel count approximately reflects the relative size of the blood vessel cross-sectional area, and the resulting time series is as follows: Figure 5C As shown, this includes periodic fluctuations caused by the cardiac cycle, as well as low-frequency drift and noise caused by respiratory movements.

[0082] To extract effective signals related to the cardiac cycle, the time series is bandpass filtered. The pass frequency range of this bandpass filter corresponds to the normal heart rate range, for example, 0.8Hz to 2Hz (corresponding to 48bpm to 120bpm). This embodiment uses an IIR bandpass filter. For example, but not limited to, with a sampling period (ultrasound imaging frame rate) of 30 fps and N=2, this simple IIR could be: Where b = [0.0017, 0, -0.0033, 0, 0.0017]; a = [1.000, -3.6442, 5.2045, -3.4344, 0.8883].

[0083] The ΔS curve after this IIR is as follows: Figure 5D This transforms into an approximately sinusoidal wave with zero DC component. To further improve the accuracy and reliability of the amplitude of change extracted from the cardiac cycle, the following RMS value is designed to characterize this change: This defines a new type of blood vessel that takes into account the direction perpendicular to the imaging plane. The instrument calculates and updates this blood supply parameter for each cardiac cycle.

[0084] This formula comprehensively considers multi-directional blood flow within the imaging plane and vascular blood flow perpendicular to the imaging plane, thus providing a more complete reflection of the blood supply activity of the target tissue. For example... Figure 8 As shown, the instrument section 200 calculates and updates the blood supply indicators after each cardiac cycle, and the ablation control module 31 adjusts the ablation parameters in real time accordingly.

[0085] Example 5 This embodiment further describes needle-body enhancement imaging technology and zone monitoring strategy based on the above embodiments.

[0086] like Figure 4 As shown, the integrated ablation device in this embodiment also has a needle-enhanced imaging function, used to more clearly display the position of the ablation needle 17 in the ultrasound image. Due to the mechanical constraint of the locking mechanism, the ablation needle 17 and the imaging plane of the ultrasound transducer 12 remain coplanar, and the angle between them is constrained within a certain range. When the angle between the ultrasound beam and the needle is between 25° and 45°, a high-echo band will form on the surface of the needle, which is most clearly displayed in the image. This embodiment utilizes this characteristic to enhance the display effect of the needle in the image by directionally emitting an ultrasound beam within the 25° to 45° angle range.

[0087] As shown in Figure 6, the ultrasonic transducer (e.g., an ultrasonic probe array) is configured to emit plane waves or weakly focused beams at multiple angles between 25° and 45° from the needle body and receive echo signals. In needle-enhanced mode, such as Figure 8 As shown, the beam control unit of the main control module 32 controls the transmitting circuit of the ultrasound front-end module 30 to generate plane waves at multiple angles such as 25°, 30°, 35°, 40°, and 45° for continuous scanning. These plane waves form incident angles with the needle surface that are conducive to strong reflection, so that the needle has a high amplitude in the echo signal.

[0088] The signal processing unit is configured to perform software beamforming on the echo signal and enhance the needle imaging according to the Frangi filter needle imaging index S. Frangi filtering is a blood vessel / linear structure enhancement algorithm based on the Hessian matrix; this embodiment applies it to needle imaging enhancement. For each pixel in the B-mode image, its HeSSian matrix is ​​calculated. Its elements are the second-order partial derivatives I of the image gray level I. xx I xy I yx I yy The HeSSian matrix is ​​decomposed into eigenvalues, yielding two eigenvalues ​​λ1 and λ2 (|λ1| ≤ |λ2|). The index is then calculated. This index reflects the circularity of the structure; for linear structures, R... B The value is close to 0, while the R value for point-like or block-like structures is close to 0. B The value is close to 1.

[0089] Frangi filter needle imaging index S is defined as... ,in, The term |λ2| is used to reward linear structures, and the term |λ2| is used to reward lines with high brightness and curvature. β is an adjustment parameter, ranging from 0.5 to 1.0, preferably 0.7. After calculating the S-value for the entire image, a threshold is set (e.g., S-values ​​greater than 30% of the maximum value), and pixels exceeding the threshold are enhanced to highlight the edges of the needle. Figure 4 As shown, the enhanced needle image is superimposed on the regular B-mode image, which enhances the display effect of the needle 17 while maintaining the overall image quality.

[0090] Because the needle enhancement mode only uses a beam within a 25° to 45° angle range, the image quality is somewhat lower compared to full-angle scanning. Depending on the actual needs, the needle enhancement mode can be operated independently or alternately at high speed with conventional large-angle plane wave B-mode and Doppler modes. In alternating operation mode, the instrument alternately transmits the needle enhancement angle beam and the conventional angle beam at a high frame rate (e.g., 1000 fps), extracting enhanced images of the area near the needle and conventional images of the entire field of view, respectively. The needle enhancement image is then superimposed on the conventional image for display. The aforementioned continuous scanning beam of 25° to 45° needle enhancement can also be embedded in... Figure 7 In the conventional multi-angle scan frame shown, beam echoes at specific angles are extracted to enhance the needle body.

[0091] This embodiment also provides a zoned monitoring strategy for more accurately assessing the efficacy and safety of ablation therapy. For example... Figure 4As shown, the signal processing unit is further configured to determine the target region of the target tissue and the surrounding region outside the target region, respectively. The target region refers to the area enclosed by the nodule outline drawn by the doctor on the user interface, i.e., the lesion tissue area that needs to be completely ablated. The surrounding region refers to the area within a certain range outside the boundary of the target region, such as a ring-shaped area within 3mm to 10mm outside the boundary of the target region, which contains normal tissue and important blood vessels that need to be protected.

[0092] The signal processing unit calculates a first blood supply index for the target region and a second blood supply index for the surrounding region. The calculation methods for the first and second blood supply indices are the same as in the aforementioned embodiments, both including a weighted sum of multi-directional blood flow velocity components within the imaging plane and a change in the vertical vessel cross-sectional area. Figure 8 As shown, the control unit is configured to compare the first blood supply index with the first threshold, compare the second blood supply index with the second threshold, and control the ablation control module 31 according to the comparison results.

[0093] The first threshold is 10% to 20% of the initial blood supply index of the target area, preferably 15%. When the first blood supply index of the target area drops below 15% of the initial value, it indicates that the blood supply to the target tissue has essentially stopped, and the ablation effect has achieved the expected goal. The second threshold is 80% to 90% of the initial blood supply index of the surrounding area, preferably 85%. When the second blood supply index of the surrounding area drops below 85% of the initial value, it indicates that the ablation range has affected the surrounding normal tissue, and there is a risk of over-ablation.

[0094] The control unit adopts a corresponding control strategy based on the comparison results of the two thresholds. When the first blood supply index is higher than the first threshold and the second blood supply index is higher than the second threshold, the control unit maintains the current ablation parameters and continues treatment. When the first blood supply index is lower than the first threshold, regardless of the status of the second blood supply index, the control unit stops ablation and sends a notification to the doctor that the treatment is complete. When the first blood supply index is higher than the first threshold but the second blood supply index is lower than the second threshold, the control unit reduces the ablation power or stops ablation and sends a warning to the doctor, indicating that the ablation area may be too large. Through the above-mentioned zone monitoring and dual-threshold control strategy, this embodiment can ensure that the target tissue is fully ablated while maximizing the protection of surrounding normal tissue, thereby improving the safety and effectiveness of treatment.

[0095] Example 6 Based on Embodiment 3, this embodiment elaborates in detail the structural design of the adjustable limit switch and its intelligent limit control method in conjunction with the main control module.

[0096] like Figure 1A and 1BAs shown, the integrated ablation probe also includes an adjustable limiter 3, used to limit the upper limit of the ablation needle 17. The adjustable limiter is located on the guide rail inside the handle, on the movement path of the needle pusher slider. Unlike the fixed limiter block described in Embodiment 3, the adjustable limiter in this embodiment has a visual scale marking and precise adjustment function. Its limit position is calculated by the main control module based on the relative positions of the target ablation point, the ablation needle guide tube, and the ultrasonic transducer.

[0097] Specifically, the adjustable limiter includes a limit slider, a dial, and a locking knob. The limit slider can slide along the guide rail and has indicator marks on its side. The dial is fixed to the outer surface of the handle and is parallel to the guide rail. The locking knob is threadedly connected to the limit slider. When the locking knob is tightened, the limit slider is pressed and fixed on the guide rail; when the locking knob is loosened, the limit slider can slide freely. The doctor adjusts the limit slider according to the limit position value calculated and displayed by the main control module, aligning the indicator marks with the corresponding scale on the dial, and then tightens the locking knob to complete the limit setting.

[0098] As in the aforementioned embodiments, the integrated ultrasonic probe includes an ultrasonic pitch angle control mechanism for adjusting the pitch angle of the ultrasonic transducer relative to the ablation needle guide tube. In this embodiment, the ultrasonic pitch angle control mechanism further includes an angle sensor for detecting the real-time angle of the pitch rotation joint and sending the pitch angle information to the main control module. The angle sensor can be a potentiometer-type angle sensor or a Hall effect angle sensor, with a detection accuracy of ±0.5° and a detection range of -30° to +30°. The output signal of the angle sensor is transmitted to the main control module of the instrument via a signal line inside the handle.

[0099] The main control module is configured to calculate the limiting position of the adjustable limiter on the ablation needle based on the relative positions of the target ablation needle guide tube and the ultrasonic transducer. The relative positions of the ablation needle guide tube and the ultrasonic transducer include pitch angle information.

[0100] After the main control module calculates the limiting distance L, it displays the value on the screen in both numerical and graphical formats, instructing the doctor to adjust the adjustable limiter to the corresponding scale position.

[0101] Here is an example of a specific operation sequence: 1. The handheld part of the device is assembled into two parts by the bayonet at the distal end and the bayonet in the upper and lower housings of the handle at the proximal end. The distal end of the handheld part is inserted into the human body through a natural cavity or surgical opening.

[0102] 2. Adjust the ultrasound transducer angle to ensure the nodule is clearly visible. Specifically, the doctor operates the adjustment lever back and forth to adjust the elevation angle of the ultrasound transducer, observing the ultrasound image on the monitor to ensure the target nodule is centered and clearly displayed. After adjustment, the angle sensor sends the current elevation angle information to the main control module.

[0103] 3. Determine the target acupuncture point on the image. On the user interface of the instrument, the doctor outlines the nodule based on the ultrasound image and marks the target acupuncture point at the center of the nodule or at a location deemed appropriate by the doctor.

[0104] 4. The computer calculates the needle pushing distance based on the relative angle between the target acupuncture point and the transducer, and indicates the position of the adjustable limiter. The main control module calculates the required pushing distance L of the ablation needle based on the above calculation formula, combined with the pitch angle θ measured by the angle sensor and the coordinates of the target acupuncture point calibrated by the doctor, and displays this value on the display, for example, "Limiter setting: 27mm".

[0105] 5. The doctor adjusts the adjustable limiter to the specified scale. The doctor loosens the locking knob of the adjustable limiter, slides the limit slider until the indicator mark is aligned with the scale position indicated by the main control module on the dial (e.g., 27mm), and then tightens the locking knob to complete the limit setting.

[0106] 6. The doctor then pushes the needle-pushing mechanism to the adjustable limiter, ensuring the needle tip reaches the target acupuncture point. The doctor operates the needle-pushing control unit, moving the needle-pushing slider along the guide rail. When the needle-pushing slider contacts the limiter slider of the adjustable limiter, it stops moving. At this point, the length of the ablation needle extending from the guide tube outlet is precisely equal to the calculated limit distance L, and the needle tip accurately reaches the target acupuncture point.

[0107] The adjustable limiter is used to prevent doctors from pushing the needle too deep due to misoperation, thus avoiding harm to the body. Because the limit position of the adjustable limiter is precisely calculated by the main control module based on ultrasound images and geometric relationships, and the doctor is physically constrained by the mechanical limit during the needle pushing process, even if the doctor uses too much force or is distracted, the ablation needle will not exceed the preset safe depth, thereby effectively protecting the important tissue structures behind the target nodule.

[0108] In another specific implementation, the adjustable limiter can also be electrically adjusted. The electrically adjustable limiter includes a stepper motor, a lead screw, and a limit block. The stepper motor is electrically connected to the main control module, which directly controls the stepper motor to drive the lead screw to rotate based on calculations, thus moving the limit block to the target position. Using an electrically adjustable method can further reduce the surgeon's operational steps and improve surgical efficiency, but it requires adding a motor and transmission mechanism inside the handle, increasing the handle's size and weight.

[0109] In another embodiment, the adjustable limiter may be omitted, and the doctor may push the needle according to the calculated limit distance L.

[0110] It should be noted that in this application, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one" does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element. In this application, if it refers to performing an action according to an element, it means performing the action at least according to that element, including two cases: performing the action only according to that element, and performing the action according to that element and other elements. Expressions such as "multiple," "repeatedly," and "various" include two, two times, two kinds, and more than two, more than two times, and more than two kinds.

[0111] This specification includes combinations of various embodiments described herein. Individual references to embodiments (e.g., “one embodiment”, “some embodiments”, or “preferred embodiments”) do not necessarily refer to the same embodiment; however, these embodiments are not mutually exclusive unless indicated to be mutually exclusive or are readily apparent to those skilled in the art. It should be noted that the word “or” is used in a non-exclusive sense throughout this specification unless the context explicitly indicates or requires it.

[0112] All references to this application are considered to be incorporated in their entirety into the disclosure of this application so that they can serve as a basis for modifications if necessary. Furthermore, it should be understood that after reading the contents of this application, those skilled in the art can make various alterations or modifications to this application, and these equivalent forms also fall within the scope of protection claimed in this application.

Claims

1. An integrated ablation device, comprising a handheld portion and an instrument portion, characterized in that, the handheld portion comprises an integrated ultrasonic probe and an integrated ablation probe, which are combined into one when in use through a detachable clamping mechanism; the integrated ultrasonic probe comprises an ultrasonic rod and an ultrasonic transducer; the integrated ablation probe comprises an ablation needle guide tube, a needle pushing mechanism and an ablation needle; after the clamping mechanism is clamped, the ultrasonic rod and the ablation needle guide tube maintain the same direction, the same plane and the fixed relative position; the needle pushing mechanism is used to push out or retract the ablation needle; the instrument portion comprises an ultrasonic front-end module, an ablation control module and a main control module; the ultrasonic front-end module is configured to realize B-mode imaging and multi-directional blood flow Doppler mode signal generation; the ablation control module is configured to control the ablation energy provided to the ablation needle; the main control module comprises a beam control unit, a signal processing unit and a control unit; the beam control unit is configured to transmit and receive multi-angle plane waves or weakly focused beams through the ultrasonic front-end module; the signal processing unit is configured to calculate multi-directional blood flow information of a target tissue according to the received beams, and calculate a blood supply index representing the blood supply activity degree according to the multi-directional blood flow information; the control unit is configured to compare the blood supply index with a preset threshold, and control the ablation energy output by the ablation needle to the target tissue through the ablation control module according to the comparison result.

2. The integrated ablation device of claim 1, wherein, the signal processing unit is configured to: obtain the multi-directional blood flow velocity components of each position in the target tissue; perform weighted calculation on the blood flow velocity components of each position to obtain the blood supply index.

3. The integrated ablation device of claim 2, wherein, the signal processing unit is configured to calculate the blood supply index in the following manner: Blood supply index = ; wherein, and are the components of the blood flow velocity at each location in the two directions, respectively, is a weighting factor for the n-th location, m is the total number of locations, said weighting factor is a function of the distance of this location relative to the center of the target tissue, said weighting factor decreasing with increasing distance.

4. The integrated ablation device of claim 1, wherein, the integrated ablation probe further comprises an adjustable limiter for limiting the upper limit of the ablation needle; the limiting position of the ablation needle by the adjustable limiter is calculated by the main control module according to the target needle insertion point, the relative position of the ablation needle guide tube and the ultrasonic transducer.

5. The integrated ablation device of claim 4, wherein, the integrated ultrasonic probe further comprises an ultrasonic pitch angle control mechanism for adjusting the pitch angle of the ultrasonic transducer relative to the ablation needle guide tube, and sending the information of the pitch angle to the main control module for calculating the limiting position of the ablation needle by the adjustable limiter; the relative position of the ablation needle guide tube and the ultrasonic transducer includes the information of the pitch angle.

6. The integrated ablation device of claim 1, wherein, the signal processing unit is configured to calculate the blood supply index in the following manner: identify the blood vessels perpendicular to the imaging plane according to the gray scale features of the ultrasonic image; continuously monitor the cross-sectional area of the blood vessels in a cardiac cycle; calculate the difference ΔS between the maximum value and the minimum value of the cross-sectional area in the cardiac cycle; calculating a blood supply indicator = ; wherein and are the maximum values of the blood flow velocity component at the respective positions within the cardiac cycle, is a weighting factor for the corresponding position, the weighting factor being a function of the distance of this position relative to the center of the target tissue, the weighting factor decreasing with increasing distance.

7. The integrated ablation device of claim 6, wherein the ablation device is configured to be inserted into the patient's body through the working channel of the endoscope. the signal processing unit is configured to calculate the ΔS in the following manner: periodically count the pixel points with a gray scale value less than a preset gray scale threshold in a target image region to form a time sequence of pixel point counts; band-pass filter the time sequence, and the pass frequency range of the band-pass filter corresponds to the range of normal heart rate; For the band-pass filtered time series, a root mean square value within a predetermined length of sliding window is calculated as the ΔS.

8. The integrated ablation device of claim 1, wherein, The ultrasonic transducer is configured to emit and receive echo signals at multiple angles of plane wave or weakly focused beams between 25° and 45° to the needle. The signal processing unit is configured to perform a software beamforming process on the echo signals and perform an enhancement process on the needle imaging according to a Frangi filter needle imaging index S.

9. The integrated ablation device of claim 1, wherein, The signal processing unit is further configured to: determine a target region of the target tissue and a peripheral region outside the target region, respectively; calculate a first blood supply index of the target region and a second blood supply index of the peripheral region, respectively; The control unit is configured to compare the first blood supply index with a first threshold value and compare the second blood supply index with a second threshold value, respectively, and control the ablation energy output by the ablation needle to the target tissue through the ablation control module according to the comparison results.

10. The integrated ablation device of claim 9, wherein, The first threshold value is 10% to 20% of the initial blood supply index of the target region, and the second threshold value is 80% to 90% of the initial blood supply index of the peripheral region.

Images