Ultrasonic and electrical stimulation dual-positioning regional anesthesia puncture guiding method and device

Abstract

The invention discloses an ultrasonic and electrical stimulation dual-positioning regional anesthesia puncture guiding method and device. The method comprises the following steps: constructing a multi-modal space-time synchronous coordinate system, acquiring sound wave echoes of an ultrasonic transducer array and electrophysiological impedance signals of a conductive tip of a puncture needle, mapping the sound wave echoes and the electrophysiological impedance signals into a data matrix and a response vector, and executing pixel-level space-time registration; inversely calculating a functional effective distance by using a neural excitability model, and generating a virtual space constraint envelope containing a safety retardation and risk early warning area; projecting the envelope to an ultrasonic imaging plane, and overlapping and displaying the visual boundary and the dynamic warning map to generate a fused guide image; the relative position of the needle point track and the envelope is monitored in real time, and when an early warning area is intruded or the distance is out of tolerance, electrical stimulation waveform parameters are automatically adjusted, and the warning state is synchronously updated. The regional anesthesia puncture guiding method solves the technical problems that according to a regional anesthesia puncture guiding method in the prior art, multi-modal data space-time registration is lacked, and functional safety boundary visualization is poor.

Description

Technical Field

[0001] This invention relates to the field of regional anesthesia technology, and more specifically, to a method and device for guiding regional anesthesia puncture using both ultrasound and electrical stimulation. Background Technology

[0002] Precise implementation of regional anesthesia depends on accurate localization of the target nerve. Currently, ultrasound imaging and electrical nerve stimulation are the two mainstream localization methods in clinical practice: the former provides real-time anatomical morphological information, while the latter provides functional feedback based on nerve excitability. However, in existing technologies, ultrasound equipment and electrical stimulators are mostly independent hardware, and their output anatomical morphological data and functional electrical stimulation data are located in the acoustic imaging coordinate system and the electrical coordinate system, respectively, exhibiting inherent heterogeneity.

[0003] Due to the lack of a unified spatiotemporal reference and registration algorithm, existing technologies cannot accurately map the functional location of electrical stimulation feedback to specific pixels in ultrasound images in real time, leading to spatial mismatch and temporal asynchrony between anatomical imaging and functional verification. Operators can only rely on experience to subjectively reconstruct space between two independent display terminals, which not only increases cognitive load but also easily causes positioning errors in complex anatomical environments. In addition, existing systems cannot invert electrophysiological parameters into quantified "functional effective distances" based on neural excitability models, and therefore cannot dynamically generate virtual safety constraint envelopes (such as safety blocking zones and risk warning zones) that change with needle tip displacement on ultrasound images. At the same time, existing electrical stimulation outputs are mostly static fixed parameters, lacking the closed-loop adaptive control capability to automatically adjust waveform parameters (such as microcurrent detection or protective cutoff) according to the relative positional relationship between the needle tip and the nerve, and thus cannot achieve active safety protection and path correction. In summary, existing regional anesthesia puncture guidance methods suffer from technical problems such as lack of spatiotemporal registration of multimodal data and poor visualization of functional safety boundaries.

[0004] There is currently no effective solution to the above problems. Summary of the Invention

[0005] This invention provides a method and apparatus for guiding regional anesthesia puncture using both ultrasound and electrical stimulation, which at least solves the technical problems of lack of spatiotemporal registration of multimodal data and poor visualization of functional safety boundaries in existing regional anesthesia puncture guidance methods.

[0006] According to one aspect of the present invention, a method for guiding regional anesthesia puncture using dual-localization of ultrasound and electrical stimulation is provided. The method includes: constructing a multimodal spatiotemporal synchronous coordinate system; acquiring acoustic echo signals from an ultrasound transducer array and electrophysiological impedance signals from the conductive tip of a puncture needle via a main control unit; mapping the acoustic echo signals into an anatomical morphology data matrix; mapping the electrophysiological impedance signals into a functional electrical stimulation response vector; and performing pixel-level spatiotemporal registration of the anatomical morphology data matrix and the functional electrical stimulation response vector under a three-dimensional spatial reference; calculating the functional effective distance between the puncture needle tip and the target nerve using a neural excitability model based on the current intensity change rate and evoked latency characteristics in the functional electrical stimulation response vector; and calculating the functional effective distance based on the functional effective distance. The effective distance generates a virtual spatial constraint envelope containing a safety blocking region and a risk warning region; the virtual spatial constraint envelope is projected onto a two-dimensional ultrasound imaging plane corresponding to the anatomical morphology data matrix, and a visual boundary marker representing the safety blocking region and a dynamic warning atlas representing the risk warning region are superimposed on the pixel layer of the real-time ultrasound image using an image synthesis algorithm to generate a fused guidance image; the relative positional relationship between the movement trajectory of the puncture needle tip and the virtual spatial constraint envelope in the fused guidance image is monitored, and when the puncture needle tip is detected to have invaded the risk warning region or the functional effective distance exceeds the safety tolerance range, the waveform parameters of the electrical stimulation output pulse are adjusted, and the state of the dynamic warning atlas in the fused guidance image is updated synchronously.

[0007] Furthermore, the above method also includes: extracting the beamforming center axis of the ultrasound transducer array as a spatial reference benchmark, acquiring the phase delay characteristics of the conductive tip of the puncture needle in the electrophysiological impedance signal to determine the spatial coordinates; using a coordinate transformation matrix to map the functional electrical stimulation response vector from the electrical coordinate system to the acoustic imaging coordinate system; performing a timestamp synchronization operation to bind each frame of the above anatomical morphology data matrix to the functional electrical stimulation response vector acquired at the same time.

[0008] Furthermore, the above method also includes: calculating the equipotential distribution field centered on the tip of the puncture needle based on the above functional effective distance; defining the equipotential surface corresponding to the minimum current threshold that induces effective nerve block as the outer boundary of the above safe blockage region; defining the equipotential surface corresponding to the maximum current density threshold that causes nerve damage as the inner boundary of the above risk warning region; and constructing a gradient transition region between the outer boundary of the above safe blockage region and the inner boundary of the above risk warning region; and continuously updating the geometry and spatial position of the above virtual space constraint envelope as the tip of the puncture needle moves.

[0009] Furthermore, the waveform parameters of the above-mentioned adjustment of the electrical stimulation output pulse include: when the tip of the puncture needle is detected to be in the above-mentioned transition region, switching to the microcurrent high-frequency detection mode, reducing the pulse width of the output pulse and increasing the sampling frequency; when the tip of the puncture needle is detected to enter the above-mentioned risk warning region, performing a protective current cutoff operation, pausing the high-voltage pulse output and switching to the low-impedance monitoring mode.

[0010] Furthermore, the aforementioned synchronous update of the dynamic warning map status in the aforementioned fused guidance image includes: recalculating the aforementioned functional effective distance based on the adjusted waveform parameters, and refreshing the boundary position of the aforementioned virtual space constraint envelope in real time; if the aforementioned functional effective distance does not converge to a safe range within multiple consecutive sampling periods, then a path correction guidance arrow is generated on the aforementioned fused guidance image.

[0011] According to another aspect of the present invention, a regional anesthesia puncture guidance device with dual ultrasound and electrical stimulation localization is also provided. The device includes: a construction unit for constructing a multimodal spatiotemporal synchronous coordinate system, acquiring acoustic echo signals from an ultrasound transducer array and electrophysiological impedance signals from the conductive tip of the puncture needle via a main control unit, mapping the acoustic echo signals into an anatomical morphology data matrix, mapping the electrophysiological impedance signals into a functional electrical stimulation response vector, and performing pixel-level spatiotemporal registration of the anatomical morphology data matrix and the functional electrical stimulation response vector under a three-dimensional spatial reference; and a first generation unit for calculating the functional effective distance between the puncture needle tip and the target nerve based on the current intensity change rate and evoked latency characteristics in the functional electrical stimulation response vector, using a neural excitability model inversion, and calculating the functional effective distance based on the functional effective distance. The system generates a virtual spatial constraint envelope containing a safety blocking region and a risk warning region. A second generation unit projects this virtual spatial constraint envelope onto a two-dimensional ultrasound imaging plane corresponding to the anatomical morphology data matrix. Using an image synthesis algorithm, it overlays and displays visual boundary markers representing the safety blocking region and dynamic warning maps representing the risk warning region onto the pixel layer of the real-time ultrasound image, generating a fused guidance image. A monitoring unit monitors the relative positional relationship between the movement trajectory of the puncture needle tip and the virtual spatial constraint envelope in the fused guidance image. When the puncture needle tip is detected to have intruded into the risk warning region or the functional effective distance exceeds the safety tolerance range, the waveform parameters of the electrical stimulation output pulse are adjusted, and the dynamic warning map status in the fused guidance image is updated synchronously.

[0012] Furthermore, the aforementioned device further includes: an extraction unit, used to extract the beamforming central axis of the ultrasound transducer array as a spatial reference benchmark, and to acquire the phase delay characteristics of the conductive tip of the puncture needle in the electrophysiological impedance signal to determine the spatial coordinates; a mapping unit, used to map the functional electrical stimulation response vector from the electrical coordinate system to the acoustic imaging coordinate system using a coordinate transformation matrix; and an execution unit, used to perform a timestamp synchronization operation, binding each frame of the anatomical morphology data matrix to the functional electrical stimulation response vector acquired at the same time.

[0013] Furthermore, the aforementioned device further includes: a first processing unit, configured to calculate an equipotential distribution field centered on the tip of the puncture needle based on the aforementioned functional effective distance, and define the equipotential surface corresponding to the minimum current threshold for inducing effective nerve block as the outer boundary of the aforementioned safe blocking region; a second processing unit, configured to define the equipotential surface corresponding to the maximum current density threshold causing nerve damage as the inner boundary of the aforementioned risk warning region, and construct a gradient transition region between the outer boundary of the aforementioned safe blocking region and the inner boundary of the aforementioned risk warning region; and an updating unit, configured to continuously update the geometry and spatial position of the aforementioned virtual spatial constraint envelope as the tip of the puncture needle moves.

[0014] Furthermore, the aforementioned monitoring unit includes: a first execution subunit, used to switch to a micro-current high-frequency detection mode, reduce the pulse width of the output pulse, and increase the sampling frequency when the tip of the puncture needle is detected to be in the aforementioned transition region; and a second execution subunit, used to perform a protective current cutoff operation, suspend the high-voltage pulse output, and switch to a low-impedance monitoring mode when the tip of the puncture needle is detected to enter the aforementioned risk warning region.

[0015] Furthermore, the monitoring unit also includes: a refresh subunit, used to recalculate the functional effective distance based on the adjusted waveform parameters and refresh the boundary position of the virtual space constraint envelope in real time; and a correction subunit, used to generate a path correction guide arrow on the fused guidance image if the functional effective distance does not converge to a safe range within multiple consecutive sampling periods.

[0016] In this embodiment of the invention, a multimodal heterogeneous data pixel-level spatiotemporal fusion and adaptive closed-loop control approach is adopted. By constructing a unified three-dimensional spatial benchmark and timestamp synchronization mechanism, the ultrasound anatomical morphology data matrix and the functional response vector of electrical stimulation are precisely registered. The functional effective distance is calculated using a neural excitability model, and a virtual spatial constraint envelope containing a safety blocking zone and a risk warning zone is dynamically generated. Then, the virtual envelope is superimposed on the ultrasound image pixel layer in real time in augmented reality form using an image synthesis algorithm to form a fused guidance image with quantified safety boundaries. Simultaneously, the system monitors the relative position of the needle tip trajectory and the virtual envelope in real time, automatically switches waveform parameters such as microcurrent detection or protective truncation according to the invasive state, and generates path correction guidance. This embodiment of the invention achieves the goal of strict synchronization and deep visualization fusion of anatomical structure imaging and neural function feedback in the spatiotemporal dimension, thereby realizing the technical effect of transitioning from qualitative experience judgment to quantitative intelligent navigation and active safety protection during the puncture process. It also solves the technical problems of lack of multimodal data spatiotemporal registration and poor visualization of functional safety boundaries in existing regional anesthesia puncture guidance methods. Attached Figure Description

[0017] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this application, illustrate exemplary embodiments of the invention and, together with their description, serve to explain the invention and do not constitute an undue limitation thereof. In the drawings:

[0018] Figure 1 This is a schematic flowchart of an optional ultrasound and electrical stimulation dual-localization regional anesthesia puncture guidance method according to an embodiment of the present invention.

[0019] Figure 2 This is a flowchart illustrating another optional regional anesthesia puncture guidance method using both ultrasound and electrical stimulation according to an embodiment of the present invention.

[0020] Figure 3 This is a schematic flowchart of another optional ultrasound and electrical stimulation dual-positioning regional anesthesia puncture guidance method according to an embodiment of the present invention.

[0021] Figure 4 This is a schematic flowchart of another optional ultrasound and electrical stimulation dual-positioning regional anesthesia puncture guidance method according to an embodiment of the present invention.

[0022] Figure 5 This is a schematic flowchart of another optional ultrasound and electrical stimulation dual-positioning regional anesthesia puncture guidance method according to an embodiment of the present invention.

[0023] Figure 6 This is a schematic diagram of an optional ultrasound and electrical stimulation dual-positioning regional anesthesia puncture guidance device according to an embodiment of the present invention. Detailed Implementation

[0024] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0025] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this invention are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover a non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0026] Example 1

[0027] According to an embodiment of the present invention, an embodiment of a regional anesthesia puncture guidance method with dual ultrasound and electrical stimulation is provided. It should be noted that the steps shown in the flowchart in the accompanying drawings can be executed in a computer system such as a set of computer-executable instructions. Furthermore, although a logical order is shown in the flowchart, in some cases, the steps shown or described may be executed in a different order than that shown here.

[0028] Figure 1 This is a schematic flowchart of an optional ultrasound and electrical stimulation dual-localization regional anesthesia puncture guidance method according to an embodiment of the present invention, as shown below. Figure 1 As shown, the method includes the following steps:

[0029] Step S102: Construct a multimodal spatiotemporal synchronous coordinate system. Acquire the acoustic echo signal of the ultrasound transducer array and the electrophysiological impedance signal of the conductive tip of the puncture needle through the main control unit. Map the acoustic echo signal into an anatomical morphology data matrix and the electrophysiological impedance signal into a functional electrical stimulation response vector. Perform pixel-level spatiotemporal registration of the anatomical morphology data matrix and the functional electrical stimulation response vector under the three-dimensional spatial reference.

[0030] Step S104: Based on the rate of change of current intensity and the characteristics of evoked latency in the functional electrical stimulation response vector, the functional effective distance between the tip of the puncture needle and the target nerve is calculated by inverting the neural excitability model, and a virtual spatial constraint envelope containing a safe blocking region and a risk warning region is generated according to the functional effective distance.

[0031] Step S106: Project the virtual space constraint envelope onto the two-dimensional ultrasound imaging plane corresponding to the anatomical morphology data matrix. Use an image synthesis algorithm to overlay and display the visualized boundary markers representing the safety blockage area and the dynamic warning map representing the risk warning area on the pixel layer of the real-time ultrasound image to generate a fused guidance image.

[0032] Step S108: Monitor the relative positional relationship between the motion trajectory of the puncture needle tip and the virtual space constraint envelope in the fusion guidance image. When it is detected that the puncture needle tip has invaded the risk warning area or the functional effective distance exceeds the safety tolerance range, adjust the waveform parameters of the electrical stimulation output pulse and update the dynamic warning spectrum status in the fusion guidance image simultaneously.

[0033] In this embodiment of the invention, a multimodal heterogeneous data pixel-level spatiotemporal fusion and adaptive closed-loop control approach is adopted. By constructing a unified three-dimensional spatial benchmark and timestamp synchronization mechanism, the ultrasound anatomical morphology data matrix and the functional response vector of electrical stimulation are precisely registered. The functional effective distance is calculated using a neural excitability model, and a virtual spatial constraint envelope containing a safety blocking zone and a risk warning zone is dynamically generated. Then, the virtual envelope is superimposed on the ultrasound image pixel layer in real time in augmented reality form using an image synthesis algorithm to form a fused guidance image with quantified safety boundaries. Simultaneously, the system monitors the relative position of the needle tip trajectory and the virtual envelope in real time, automatically switches waveform parameters such as microcurrent detection or protective truncation according to the invasive state, and generates path correction guidance. This embodiment of the invention achieves the goal of strict synchronization and deep visualization fusion of anatomical structure imaging and neural function feedback in the spatiotemporal dimension, thereby realizing the technical effect of transitioning from qualitative experience judgment to quantitative intelligent navigation and active safety protection during the puncture process. It also solves the technical problems of lack of multimodal data spatiotemporal registration and poor visualization of functional safety boundaries in existing regional anesthesia puncture guidance methods.

[0034] Optionally, in step S102, the system first constructs a multimodal spatiotemporal synchronous coordinate system. The main control unit acquires the acoustic echo signal from the ultrasound transducer array and the electrophysiological impedance signal from the conductive tip of the puncture needle in real time. The system maps the acoustic echo signal into a high-resolution anatomical morphology data matrix, and simultaneously maps the electrophysiological impedance signal into a functional electrical stimulation response vector. Subsequently, the central axis of the ultrasound beam is extracted as a spatial reference, and the response vector in the electrical coordinate system is mapped to the acoustic imaging coordinate system using a coordinate transformation matrix. A timestamp synchronization operation is then performed to ensure that each frame of anatomical data and the functional data at the same time are registered at the pixel level in a three-dimensional spatial reference, eliminating spatial mismatch errors between heterogeneous data.

[0035] Optionally, in step S104, the system extracts the current intensity change rate and evoked latency characteristics based on the registered functional electrical stimulation response vector, substitutes them into a preset neural excitability model (such as an intensity-time curve model), and inversely calculates the functional effective distance between the puncture needle tip and the target nerve. Based on this distance, the system calculates the isopotential distribution field centered on the needle tip, defines the minimum current threshold equipotential surface for effective blockade as the outer boundary of the safe blockade region, and defines the maximum damaging current density equipotential surface as the inner boundary of the risk warning region, thereby dynamically generating a virtual spatial constraint envelope containing a gradient transition zone. The neural excitability model is a nonlinear mapping function constructed based on the intensity-time curve principle, and its input variables include the stimulation current amplitude, pulse width, and muscle contraction response threshold.

[0036] Optionally, in step S106, the system projects the virtual spatial constraint envelope onto the two-dimensional ultrasound imaging plane, and uses a multi-channel Alpha hybrid image synthesis algorithm to overlay and render a semi-transparent boundary marker representing the safe area and a bright flashing warning map representing the risk area on the pixel layer of the real-time ultrasound image to generate an intuitive fused guidance image.

[0037] Optionally, in step S108, the system monitors the relative position of the needle tip trajectory and the virtual envelope in real time. Once the system detects that the needle tip has entered the risk warning area or that the functional effective distance has exceeded the safety tolerance, the system immediately triggers closed-loop control: if the needle tip is in the transition zone, it automatically switches to the micro-current high-frequency detection mode; if it enters the risk zone, it performs protective current cutoff and switches to the low impedance monitoring mode, while refreshing the warning spectrum status and generating path correction guidance until the operation returns to the safe range.

[0038] This embodiment achieves deep fusion and intelligent closed-loop guidance of multimodal data through steps S102 to S108. Technically, a multimodal spatiotemporal synchronous coordinate system is first constructed, mapping ultrasound echoes and electrophysiological impedance signals to anatomical matrices and functional vectors, respectively. Pixel-level spatiotemporal registration is then performed using coordinate transformation and timestamp binding to eliminate spatiotemporal deviations between heterogeneous data. Subsequently, the functional effective distance is calculated based on a neural excitability model, dynamically generating a virtual spatial constraint envelope containing a safety blocking zone and a risk warning zone. Next, a multi-channel Alpha mixing algorithm is used to semi-transparently overlay this envelope onto the real-time ultrasound image, generating a fused guidance image that combines anatomical details and functional boundaries. Finally, the relative position of the needle tip trajectory and the envelope is monitored in real time. Once the risk zone is invaded or the distance exceeds the tolerance, the electrical stimulation waveform parameters are automatically adjusted (e.g., switching microcurrent mode or cutting off output) and the warning status is refreshed. This technology achieves precise spatiotemporal alignment and visualized quantitative display of anatomical morphology and functional feedback, realizes the transformation of puncture navigation from "experience-based judgment" to "data-driven", and provides proactive safety protection during the operation process. It effectively solves the technical problems of fragmented multimodal information and invisible functional safety boundaries.

[0039] Optionally, Figure 2 This is a flowchart illustrating another optional ultrasound and electrical stimulation dual-localization regional anesthesia puncture guidance method according to an embodiment of the present invention, as shown below. Figure 2 As shown, the method includes the following steps:

[0040] Step S202: Extract the beamforming center axis of the ultrasound transducer array as a spatial reference benchmark, and collect the phase delay characteristics of the conductive tip of the puncture needle in the electrophysiological impedance signal to determine the spatial coordinates.

[0041] Step S204: The functional electrical stimulation response vector is mapped from the electrical coordinate system to the acoustic imaging coordinate system using a coordinate transformation matrix;

[0042] Step S206: Perform a timestamp synchronization operation to bind each frame of anatomical morphology data matrix to the functional electrical stimulation response vector acquired at the same time.

[0043] Optionally, in step S202, the system first establishes a unified spatial reference benchmark. Specifically, the beamforming center axis of the ultrasound transducer array is extracted as the zero-position reference of the acoustic coordinate system, which defines the normal and depth directions of the ultrasound imaging plane. Simultaneously, the main control unit acquires the electrophysiological impedance signal of the conductive tip of the puncture needle in biological tissue in real time, and extracts the phase delay characteristics of the signal relative to the excitation source through a high-precision phase detection circuit. Since the phase delay is linearly related to the signal propagation path length, the system uses this characteristic to calculate the precise physical coordinates of the puncture needle tip in three-dimensional space, thereby transforming the abstract electrical signal into a position vector with spatial attributes.

[0044] Optionally, in step S204, a cross-domain coordinate mapping operation is performed. Given the inherent differences between the electrical coordinate system of the electrostimulator and the acoustic imaging coordinate system of the ultrasound equipment in terms of origin definition, axial direction, and scale, the system invokes a preset rigid body transformation matrix (including rotation and translation vectors) to losslessly map the functional electrostimulation response vector determined in step S202 from the electrical coordinate system to the acoustic imaging coordinate system. This process eliminates spatial mismatch errors caused by changes in the probe's handheld angle or the needle's insertion angle, ensuring that the functional location point of the electrostimulation feedback accurately falls on the corresponding pixel position in the ultrasound image.

[0045] Optionally, in step S206, a strict timestamp synchronization operation is implemented. The system assigns a unique high-precision timestamp to each frame of high-speed refreshed anatomical morphology data matrix and forcibly binds it to the functional electrical stimulation response vector acquired at the same time. Through this frame-level data association mechanism, strict alignment of anatomical image updates and functional signal feedback in the time dimension is ensured during dynamic puncture, avoiding the "image-signal" lag phenomenon caused by processing delays.

[0046] Optionally, through the above steps S202 to S206, this embodiment achieves accurate registration of heterogeneous sensor data in the spatiotemporal dimension, laying a solid data foundation for the subsequent generation of high-confidence fusion guidance images, and effectively solving the positioning deviation problem caused by spatiotemporal asynchrony in traditional dual-modal positioning.

[0047] Optionally, Figure 3 This is a schematic flowchart of another optional ultrasound and electrical stimulation dual-localization regional anesthesia puncture guidance method according to an embodiment of the present invention, as shown below. Figure 3 As shown, the method includes the following steps:

[0048] Step S302: Calculate the equipotential distribution field with the tip of the puncture needle as the center based on the functional effective distance, and define the equipotential surface corresponding to the minimum current threshold for inducing effective nerve block as the outer boundary of the safe blockage area.

[0049] Step S304: Define the equipotential surface corresponding to the maximum current density threshold that causes nerve damage as the inner boundary of the risk warning region, and construct a gradient transition region between the outer boundary of the safety blocking region and the inner boundary of the risk warning region.

[0050] In step S306, as the tip of the puncture needle moves, the geometry and spatial position of the virtual space constraint envelope are continuously updated.

[0051] Optionally, in step S302, the system initiates a bioelectric field modeling procedure based on the "functional effective distance" calculated in the previous step. Specifically, using the conductive tip of the real-time positioned puncture needle as the geometric center, and combining it with the equivalent conductivity of the current biological tissue, the system calculates the equipotential distribution field around the needle tip. The system precisely defines the three-dimensional equipotential surface corresponding to the minimum current threshold (e.g., 0.3mA) that can induce effective nerve block, pre-calibrated through clinical trials, as the outer boundary of the "safe blockage region." This boundary physically represents the ideal range of action for producing the expected anesthetic effect after local anesthetic injection, providing the operator with a clear "target arrival surface."

[0052] Optionally, in step S304, the system further defines the risk boundary and constructs a buffer mechanism. The equipotential surface corresponding to the maximum current density threshold (or the strong electric field effect at extremely close range) that causes irreversible damage to neural structures is strictly defined as the inner boundary of the "risk warning area". Between this inner boundary and the outer boundary of the safe blocking area, the system uses linear or nonlinear interpolation algorithms to construct a "transition region" with a gradient change in current density. This region reflects the probabilistic transition from "effective blocking" to "potential damage" at the data level, avoiding the binary judgment defects of traditional technologies and providing the operator with fault tolerance.

[0053] Optionally, in step S306, a dynamic geometry update mechanism is implemented. As the puncture operation proceeds, the main control unit tracks the displacement vector of the puncture needle tip in real time, recalculates the equipotential distribution field at millisecond frequencies, and continuously updates the geometry (such as deformation due to tissue impedance inhomogeneity) and spatial position of the virtual spatial constraint envelope. This ensures that the envelope always closely follows the needle tip movement like a "dynamic shield," accurately reflecting the current instantaneous safety status.

[0054] Optionally, through the above steps S302 to S306, this embodiment realizes the quantitative modeling and real-time visualization of functional safety boundaries, transforming the invisible electric field distribution into visible spatial constraints, enabling operators to intuitively predict the blocking effect and damage risk, and significantly improving the safety and accuracy of puncture operations.

[0055] Optionally, Figure 4 This is a schematic flowchart of another optional ultrasound and electrical stimulation dual-localization regional anesthesia puncture guidance method according to an embodiment of the present invention, as shown below. Figure 4 As shown, adjusting the waveform parameters of the electrical stimulation output pulse includes the following steps:

[0056] Step S402: When the tip of the puncture needle is detected to be in the transition region, switch to the microcurrent high-frequency detection mode, reduce the pulse width of the output pulse and increase the sampling frequency.

[0057] Step S404: When the tip of the puncture needle is detected to have entered the risk warning area, a protective current cutoff operation is performed to pause the high-voltage pulse output and switch to the low-impedance monitoring mode.

[0058] Optionally, in step S402, when the system detects that the tip of the puncture needle has entered the aforementioned "transition region," it determines that the operation has entered the fine positioning stage. At this time, the main control unit automatically switches the electrical stimulation output to "micro-current high-frequency detection mode." This significantly reduces the pulse width of the output pulse (e.g., from the conventional 0.1ms to 0.05ms) to reduce the energy injection of a single stimulation and avoid prematurely inducing strong muscle contractions that interfere with the operation; at the same time, it greatly increases the signal sampling frequency to capture weak changes in nerve excitability electrical signals. This mode can improve the resolution of nerve location discrimination without causing significant discomfort to the patient, achieving precise approximation with "high sensitivity and low interference."

[0059] Optionally, in step S404, when the system detects that the puncture needle tip has exceeded the safety threshold and entered the "risk warning area," it immediately triggers the highest-priority "protective current cutoff operation." The main control unit pauses all high-voltage pulse outputs within milliseconds, completely cutting off the current source that could cause nerve electrical damage, and seamlessly switches to "low-impedance monitoring mode." In this mode, the system only emits microampere-level detection signals to monitor changes in tissue impedance, without providing excitatory stimulation. This ensures that even in cases of operational errors or hand tremors causing the needle tip to be too close, nerve thermal or electrochemical damage can be prevented from the physical source.

[0060] Optionally, through the above steps S402 to S404, a technological leap from "passive stimulation" to "active protection" is achieved, constructing an adaptive safety barrier based on real-time position feedback, which greatly reduces the risk of neurological complications during regional anesthesia puncture.

[0061] Optionally, Figure 5 This is a schematic flowchart of another optional ultrasound and electrical stimulation dual-localization regional anesthesia puncture guidance method according to an embodiment of the present invention, as shown below. Figure 5 As shown, the synchronous update of the dynamic warning map status in the fused guidance image includes the following steps:

[0062] Step S502: Recalculate the functional effective distance based on the adjusted waveform parameters, and refresh the boundary position of the virtual space constraint envelope in real time;

[0063] Step S504: If the functional effective distance does not converge to a safe range within multiple consecutive sampling periods, a path correction guide arrow is generated on the fused guide image.

[0064] Optionally, in step S502, the system establishes a two-way feedback closed loop for control and display. When step S402 or S404 is completed, causing a change in the electrical stimulation waveform parameters (such as pulse width, frequency, or amplitude), the main control unit immediately recalculates the current "functional effective distance" using the adjusted new parameters and the neural excitability model. Since the change in stimulation energy directly alters the radius of the electric field, the original virtual spatial constraint envelope boundary is no longer accurate. Therefore, based on the newly calculated distance value, the system refreshes the geometric boundary positions of the safety blocking area and the risk warning area in the fused guidance image in real time. This process ensures that the colored warning range seen by the doctor on the screen strictly matches the actual physical stimulation field output by the device, eliminating visual lag or misleading effects caused by parameter adjustments.

[0065] Optionally, in step S504, the system introduces a convergence judgment mechanism in the time dimension to provide active navigation assistance. If the system detects that the calculated functional effective distance fails to converge to the preset safety tolerance range within multiple consecutive preset sampling periods (e.g., within 1 second), it indicates that the current needle insertion path has a persistent deviation or has encountered an anatomical barrier. At this time, the algorithm automatically generates a dynamic "path correction guide arrow" on a specific layer of the fused guide image. The direction of this arrow is calculated based on the vector difference between the current needle tip coordinates and the center of the target safety area, intuitively indicating the specific direction in which the operator should adjust the needle insertion angle or depth.

[0066] Optionally, through the above steps S502 to S504, this embodiment realizes dynamic self-consistency and intelligent error correction of guidance information, upgrades traditional static observation to dynamic interactive guidance, effectively reduces the puncture failure rate caused by operation path deviation, and improves the one-time success rate of regional anesthesia operation.

[0067] In this embodiment of the invention, a multimodal heterogeneous data pixel-level spatiotemporal fusion and adaptive closed-loop control approach is adopted. By constructing a unified three-dimensional spatial benchmark and timestamp synchronization mechanism, the ultrasound anatomical morphology data matrix and the functional response vector of electrical stimulation are precisely registered. The functional effective distance is calculated using a neural excitability model, and a virtual spatial constraint envelope containing a safety blocking zone and a risk warning zone is dynamically generated. Then, the virtual envelope is superimposed on the ultrasound image pixel layer in real time in augmented reality form using an image synthesis algorithm to form a fused guidance image with quantified safety boundaries. Simultaneously, the system monitors the relative position of the needle tip trajectory and the virtual envelope in real time, automatically switches waveform parameters such as microcurrent detection or protective truncation according to the invasive state, and generates path correction guidance. This embodiment of the invention achieves the goal of strict synchronization and deep visualization fusion of anatomical structure imaging and neural function feedback in the spatiotemporal dimension, thereby realizing the technical effect of transitioning from qualitative experience judgment to quantitative intelligent navigation and active safety protection during the puncture process. It also solves the technical problems of lack of multimodal data spatiotemporal registration and poor visualization of functional safety boundaries in existing regional anesthesia puncture guidance methods.

[0068] Example 2

[0069] According to another aspect of the present invention, a regional anesthesia puncture guidance device with dual ultrasound and electrical stimulation localization is also provided. Figure 6 This is a schematic diagram of an optional ultrasound and electrical stimulation dual-positioning regional anesthesia puncture guidance device according to an embodiment of the present invention, as shown below. Figure 6 As shown, the device includes:

[0070] The construction unit 601 is used to construct a multimodal spatiotemporal synchronous coordinate system. The main control unit collects the acoustic echo signal of the ultrasound transducer array and the electrophysiological impedance signal of the conductive tip of the puncture needle. The acoustic echo signal is mapped into an anatomical morphology data matrix, and the electrophysiological impedance signal is mapped into a functional electrical stimulation response vector. Pixel-level spatiotemporal registration is performed on the anatomical morphology data matrix and the functional electrical stimulation response vector under a three-dimensional spatial reference.

[0071] The first generation unit 603 is used to calculate the functional effective distance between the tip of the puncture needle and the target nerve based on the rate of change of current intensity and the characteristics of the evoked latency in the functional electrical stimulation response vector, using a neural excitability model, and to generate a virtual spatial constraint envelope containing a safe blocking region and a risk warning region based on the functional effective distance.

[0072] The second generation unit 605 is used to project the virtual space constraint envelope onto the two-dimensional ultrasound imaging plane corresponding to the anatomical morphology data matrix, and to overlay and display the visual boundary markers representing the safety blockage area and the dynamic warning map representing the risk warning area on the pixel layer of the real-time ultrasound image through the image synthesis algorithm, thereby generating a fused guidance image.

[0073] The monitoring unit 607 is used to monitor the relative positional relationship between the movement trajectory of the puncture needle tip and the virtual space constraint envelope in the fusion guidance image. When it is detected that the puncture needle tip has invaded the risk warning area or the functional effective distance exceeds the safety tolerance range, the waveform parameters of the electrical stimulation output pulse are adjusted, and the dynamic warning spectrum status in the fusion guidance image is updated synchronously.

[0074] Optionally, the device may further include: an extraction unit for extracting the beamforming central axis of the ultrasound transducer array as a spatial reference, and acquiring the phase delay characteristics of the conductive tip of the puncture needle in the electrophysiological impedance signal to determine the spatial coordinates; a mapping unit for mapping the functional electrical stimulation response vector from the electrical coordinate system to the acoustic imaging coordinate system using a coordinate transformation matrix; and an execution unit for performing a timestamp synchronization operation to bind each frame of anatomical morphology data matrix to the functional electrical stimulation response vector acquired at the same time.

[0075] Optionally, the device may further include: a first processing unit, configured to calculate an equipotential distribution field centered on the tip of the puncture needle based on the functional effective distance, and define the equipotential surface corresponding to the minimum current threshold for inducing effective nerve block as the outer boundary of the safe block region; a second processing unit, configured to define the equipotential surface corresponding to the maximum current density threshold causing nerve damage as the inner boundary of the risk warning region, and construct a gradient transition region between the outer boundary of the safe block region and the inner boundary of the risk warning region; and an updating unit, configured to continuously update the geometry and spatial position of the virtual spatial constraint envelope as the tip of the puncture needle moves.

[0076] Optionally, the monitoring unit may include: a first execution subunit, used to switch to a microcurrent high-frequency detection mode, reduce the pulse width of the output pulse and increase the sampling frequency when the puncture needle tip is detected to be in the transition region; and a second execution subunit, used to perform a protective current cutoff operation, pause the high-voltage pulse output and switch to a low-impedance monitoring mode when the puncture needle tip is detected to enter the risk warning region.

[0077] Optionally, the monitoring unit may further include: a refresh subunit, used to recalculate the functional effective distance according to the adjusted waveform parameters and refresh the boundary position of the virtual space constraint envelope in real time; and a correction subunit, used to generate a path correction guide arrow on the fused guide image if the functional effective distance does not converge to a safe range within multiple consecutive sampling periods.

[0078] In this embodiment of the invention, a multimodal heterogeneous data pixel-level spatiotemporal fusion and adaptive closed-loop control approach is adopted. By constructing a unified three-dimensional spatial benchmark and timestamp synchronization mechanism, the ultrasound anatomical morphology data matrix and the functional response vector of electrical stimulation are precisely registered. The functional effective distance is calculated using a neural excitability model, and a virtual spatial constraint envelope containing a safety blocking zone and a risk warning zone is dynamically generated. Then, the virtual envelope is superimposed on the ultrasound image pixel layer in real time in augmented reality form using an image synthesis algorithm to form a fused guidance image with quantified safety boundaries. Simultaneously, the system monitors the relative position of the needle tip trajectory and the virtual envelope in real time, automatically switches waveform parameters such as microcurrent detection or protective truncation according to the invasive state, and generates path correction guidance. This embodiment of the invention achieves the goal of strict synchronization and deep visualization fusion of anatomical structure imaging and neural function feedback in the spatiotemporal dimension, thereby realizing the technical effect of transitioning from qualitative experience judgment to quantitative intelligent navigation and active safety protection during the puncture process. It also solves the technical problems of lack of multimodal data spatiotemporal registration and poor visualization of functional safety boundaries in existing regional anesthesia puncture guidance methods.

[0079] The sequence numbers of the above embodiments of the present invention are for descriptive purposes only and do not represent the superiority or inferiority of the embodiments.

[0080] In the above embodiments of the present invention, the descriptions of each embodiment have different focuses. For parts not described in detail in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0081] In the several embodiments provided in this application, it should be understood that the disclosed technical content can be implemented in other ways. The device embodiments described above are merely illustrative; for example, the division of units can be a logical functional division, and in actual implementation, there may be other division methods. For instance, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Furthermore, the displayed or discussed mutual coupling, direct coupling, or communication connection may be through some interfaces; the indirect coupling or communication connection between units or modules may be electrical or other forms.

[0082] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0083] Furthermore, the functional units in the various embodiments of the present invention can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit. The integrated unit can be implemented in hardware or as a software functional unit.

[0084] If the integrated unit is implemented as a software functional unit and sold or used as an independent product, it can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of the present invention, in essence, or the part that contributes to the prior art, or all or part of the technical solution, can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) to execute all or part of the steps of the methods described in the various embodiments of the present invention. The aforementioned storage medium includes various media capable of storing program code, such as USB flash drives, read-only memory (ROM), random access memory (RAM), portable hard drives, magnetic disks, or optical disks.

[0085] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A method for guiding regional anesthesia puncture using both ultrasound and electrical stimulation, characterized in that, include: A multimodal spatiotemporal synchronous coordinate system is constructed. The acoustic echo signal of the ultrasound transducer array and the electrophysiological impedance signal of the conductive tip of the puncture needle are acquired by the main control unit. The acoustic echo signal is mapped into an anatomical morphology data matrix, and the electrophysiological impedance signal is mapped into a functional electrical stimulation response vector. Pixel-level spatiotemporal registration is performed on the anatomical morphology data matrix and the functional electrical stimulation response vector under a three-dimensional spatial reference. Based on the current intensity change rate and evoked latency characteristics in the functional electrical stimulation response vector, the functional effective distance between the puncture needle tip and the target nerve is calculated by inverting the neural excitability model, and a virtual spatial constraint envelope containing a safe blocking region and a risk warning region is generated according to the functional effective distance. The virtual spatial constraint envelope is projected onto a two-dimensional ultrasound imaging plane corresponding to the anatomical morphology data matrix. A visual boundary marker representing the safety blockage area and a dynamic warning map representing the risk warning area are superimposed on the pixel layer of the real-time ultrasound image using an image synthesis algorithm to generate a fused guidance image. The relative positional relationship between the movement trajectory of the puncture needle tip and the virtual space constraint envelope in the fusion guidance image is monitored. When the puncture needle tip is detected to have invaded the risk warning area or the functional effective distance exceeds the safety tolerance range, the waveform parameters of the electrical stimulation output pulse are adjusted, and the dynamic warning spectrum status in the fusion guidance image is updated synchronously.

2. The regional anesthesia puncture guidance method using dual ultrasound and electrical stimulation as described in claim 1, characterized in that, The method further includes: The beamforming center axis of the ultrasound transducer array is extracted as a spatial reference, and the phase delay characteristics of the conductive tip of the puncture needle in the electrophysiological impedance signal are collected to determine the spatial coordinates. The functional electrical stimulation response vector is mapped from the electrical coordinate system to the acoustic imaging coordinate system using a coordinate transformation matrix; Perform a timestamp synchronization operation to bind each frame of the anatomical morphology data matrix to the functional electrical stimulation response vector acquired at the same time.

3. The regional anesthesia puncture guidance method using dual ultrasound and electrical stimulation as described in claim 1, characterized in that, The method further includes: Based on the functional effective distance, the equipotential distribution field with the tip of the puncture needle as the center is calculated, and the equipotential surface corresponding to the minimum current threshold for inducing effective nerve block is defined as the outer boundary of the safe blockage region. The equipotential surface corresponding to the maximum current density threshold that causes nerve damage is defined as the inner boundary of the risk warning region, and a gradient transition region is constructed between the outer boundary of the safety blocking region and the inner boundary of the risk warning region. As the tip of the puncture needle moves, the geometry and spatial position of the virtual space constraint envelope are continuously updated.

4. The regional anesthesia puncture guidance method using dual ultrasound and electrical stimulation as described in claim 3, characterized in that, The waveform parameters of the adjusted electrical stimulation output pulse include: When the tip of the puncture needle is detected to be in the transition region, the system switches to the microcurrent high-frequency detection mode to reduce the pulse width of the output pulse and increase the sampling frequency. When the tip of the puncture needle is detected to have entered the risk warning area, a protective current cutoff operation is performed, the high-voltage pulse output is paused, and the system switches to low-impedance monitoring mode.

5. The regional anesthesia puncture guidance method using dual ultrasound and electrical stimulation as described in claim 1, characterized in that, The synchronous update of the dynamic warning map status in the fused guidance image includes: The functional effective distance is recalculated based on the adjusted waveform parameters, and the boundary position of the virtual space constraint envelope is refreshed in real time. If the functional effective distance fails to converge to a safe range within multiple consecutive sampling periods, a path correction guide arrow is generated on the fused guidance image.

6. A regional anesthesia puncture guidance device with dual positioning of ultrasound and electrical stimulation, characterized in that, include: The construction unit is used to construct a multimodal spatiotemporal synchronous coordinate system. The main control unit acquires the acoustic echo signal of the ultrasound transducer array and the electrophysiological impedance signal of the conductive tip of the puncture needle. The acoustic echo signal is mapped into an anatomical morphology data matrix, and the electrophysiological impedance signal is mapped into a functional electrical stimulation response vector. Pixel-level spatiotemporal registration is performed on the anatomical morphology data matrix and the functional electrical stimulation response vector under a three-dimensional spatial reference. The first generation unit is used to calculate the functional effective distance between the tip of the puncture needle and the target nerve based on the rate of change of current intensity and the characteristics of the evoked latency in the functional electrical stimulation response vector, using a neural excitability model, and to generate a virtual spatial constraint envelope containing a safe blocking region and a risk warning region based on the functional effective distance. The second generation unit is used to project the virtual space constraint envelope onto a two-dimensional ultrasound imaging plane corresponding to the anatomical morphology data matrix, and to overlay and display a visual boundary marker representing the safety blockage area and a dynamic warning map representing the risk warning area on the pixel layer of the real-time ultrasound image through an image synthesis algorithm, thereby generating a fused guidance image. The monitoring unit is used to monitor the relative positional relationship between the movement trajectory of the puncture needle tip and the virtual space constraint envelope in the fusion guidance image. When the puncture needle tip is detected to have invaded the risk warning area or the functional effective distance exceeds the safety tolerance range, the waveform parameters of the electrical stimulation output pulse are adjusted, and the dynamic warning spectrum status in the fusion guidance image is updated synchronously.

7. The ultrasound and electrical stimulation dual-positioning regional anesthesia puncture guidance device according to claim 6, characterized in that, The device further includes: The extraction unit is used to extract the beamforming center axis of the ultrasound transducer array as a spatial reference, and to collect the phase delay characteristics of the conductive tip of the puncture needle in the electrophysiological impedance signal to determine the spatial coordinates. A mapping unit is used to map the functional electrical stimulation response vector from the electrical coordinate system to the acoustic imaging coordinate system using a coordinate transformation matrix; An execution unit is used to perform a timestamp synchronization operation, binding each frame of the anatomical morphology data matrix to the functional electrical stimulation response vector acquired at the same time.

8. The ultrasound and electrical stimulation dual-positioning regional anesthesia puncture guidance device according to claim 6, characterized in that, The device further includes: The first processing unit is used to calculate the equipotential distribution field with the tip of the puncture needle as the center based on the functional effective distance, and to define the equipotential surface corresponding to the minimum current threshold for inducing effective nerve block as the outer boundary of the safe blockage area. The second processing unit is used to define the equipotential surface corresponding to the maximum current density threshold that causes nerve damage as the inner boundary of the risk warning region, and to construct a gradient transition region between the outer boundary of the safety blocking region and the inner boundary of the risk warning region. The update unit is used to continuously update the geometry and spatial position of the virtual space constraint envelope as the tip of the puncture needle moves.

9. The ultrasound and electrical stimulation dual-positioning regional anesthesia puncture guidance device according to claim 8, characterized in that, The monitoring unit includes: The first execution subunit is used to switch to the microcurrent high-frequency detection mode when the tip of the puncture needle is detected to be in the transition region, thereby reducing the pulse width of the output pulse and increasing the sampling frequency. The second execution subunit is used to perform a protective current cutoff operation, suspend the high-voltage pulse output and switch to low-impedance monitoring mode when the tip of the puncture needle is detected to enter the risk warning area.

10. The ultrasound and electrical stimulation dual-positioning regional anesthesia puncture guidance device according to claim 6, characterized in that, The monitoring unit also includes: The refresh subunit is used to recalculate the functional effective distance based on the adjusted waveform parameters and refresh the boundary position of the virtual space constraint envelope in real time. The correction subunit is used to generate a path correction guide arrow on the fused guidance image if the functional effective distance does not converge to a safe range within multiple consecutive sampling periods.

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