Safe and high-success-rate operation method and system for sternum marrow puncture

Abstract

The invention relates to the technical field of clinical medical instruments and operation, and discloses a safe and high-success-rate operation method and system for sternum marrow puncture. The invention provides a closed-loop solution based on multi-modal information fusion and intelligent control in order to solve the pain points that traditional sternum paracentesis highly depends on experience of doctors, the complication risk is high and the success rate is unstable. According to the method, a patient personalized three-dimensional model is constructed through images such as preoperative CT or intraoperative ultrasound, risk early warning is conducted through a machine learning model, and an optimal puncture track is generated through a path planning algorithm. The core innovation of the method is as follows: in the puncture process, real-time image navigation and needle point pressure feedback are dynamically combined, and the subjective'falling sense 'is quantified into objective data for the first time so as to accurately control the depth; a set of intelligent safety braking system is integrated, the puncture needle can be automatically locked when it is monitored that thrust is abnormal, and the fatal risk that the heart and great blood vessels are damaged due to too deep puncture is actively avoided.

Description

Technical Field

[0001] This invention relates to the field of clinical medical devices and procedures, and in particular to a safe and highly successful method and system for sternal bone marrow aspiration. Background Technology

[0002] Traditional sternal bone marrow aspiration relies entirely on the doctor's subjective experience and feel. This "blind" approach not only leads to an unstable success rate but also carries the risk of fatal complications due to the presence of vital organs such as the heart behind the sternum.

[0003] To enhance safety, existing technologies have developed guidance systems that combine real-time ultrasound imaging with pressure sensing. These systems visualize positional and mechanical information, providing doctors with objective judgment and representing a significant improvement over purely tactile manipulation. However, such solutions are essentially passive information presentation tools. Their fundamental flaws are twofold: firstly, single images or mechanical signals can lead to misjudgments due to various interferences; secondly, and most importantly, they rely entirely on human reaction speed to execute the final braking maneuver.

[0004] Given the extremely rapid process of penetrating the cortical bone, the inherent delay in human neural response makes it impossible for operators to reliably avoid over-puncture due to delayed reactions. Therefore, the field still lacks a solution capable of intelligently integrating multiple physical signals to achieve high-confidence tissue identification, and on this basis, providing an active, automated safety braking mechanism, thereby transforming operational safety from relying on passive human response to being proactively ensured by the system. Summary of the Invention

[0005] In view of the aforementioned existing problems, the present invention is proposed.

[0006] Therefore, this invention provides a safe and highly successful method for sternal bone marrow aspiration, overcoming the fundamental defects in existing bone marrow aspiration guidance techniques, and providing a new technical solution that transforms operational safety from relying on passive human response to being actively guaranteed by the system.

[0007] To solve the above-mentioned technical problems, the present invention provides the following technical solution:

[0008] In a first aspect, the present invention provides a safe and highly successful method for sternal bone marrow aspiration, which includes the following steps:

[0009] S1. Advance a specially designed puncture needle with a sensor integrated in its tip area for sensing information about different physical properties.

[0010] S2. During the advancement of the puncture needle, at least three signal streams with different physical properties are acquired in real time and synchronously through the sensing device. The signal streams respectively characterize the mechanical, electrical and acoustic properties of the local tissue area in front of the needle tip that directly interacts with the sensor.

[0011] S3. Perform real-time analysis of the three signal streams on the same time axis to identify a landmark event characterizing the breakthrough of the puncture needle tip from the dense cortical bone layer into the loose medullary cavity.

[0012] S4. The landmark event is defined as the mechanical characteristic signal of the needle tip load dropping sharply in a very short time, the electrical characteristic signal of the bioelectrical impedance value measured by the microelectrode on the needle tip dropping sharply in a very short time, and the acoustic characteristic signal of the sound wave emitted by the micro ultrasonic transducer on the needle tip changing its echo signal morphology when it encounters different tissue interfaces. All three occur simultaneously within a preset very short time period.

[0013] S5. If the landmark event is identified, the central processing unit will trigger the electromechanical actuator capable of locking and retracting the puncture needle based on the judgment result of the landmark event, thereby terminating and locking the further movement of the puncture needle along its own central axis.

[0014] As a preferred embodiment of the safe and high-success-rate sternal bone marrow aspiration method of the present invention, a specially designed puncture needle with a sensing device integrated in its tip region for sensing different physical properties is advanced. During the advancement of the puncture needle, at least three signal streams with different physical properties are acquired in real time and synchronously through the sensing device. The signal streams respectively characterize the mechanical, electrical, and acoustic properties of the local tissue region in front of the needle tip that directly interacts with the sensor. The specific steps are as follows:

[0015] The specially designed puncture needle for propulsion has a sensing device that specifically includes: a mechanical sensor for acquiring the mechanical characteristic signal, which is integrated into the force transmission path of the puncture needle to measure the thrust along its axial direction; an electrical sensor for acquiring the electrical characteristic signal, which is disposed in the form of a multi-electrode array on the outer surface of the distal end of the puncture needle tip to measure the bioelectrical impedance of the local tissue in front of the needle tip; and an acoustic sensor for acquiring the acoustic characteristic signal, which is arranged at the distal end of the puncture needle to emit ultrasonic waves and receive their echo signals in the tissue.

[0016] As a preferred embodiment of the safe and high-success-rate sternal bone marrow aspiration method described in this invention, the following steps are taken: Real-time analysis of three signal streams is performed on the same time axis to identify a landmark event characterizing the breakthrough of the puncture needle tip from the dense cortical bone layer into the porous medullary cavity. This landmark event is defined as: a mechanical characteristic signal showing a significant decrease in needle tip load within a very short time; an electrical characteristic signal showing a sharp decrease in bioelectrical impedance measured by the microelectrode on the needle tip within a very short time; and an acoustic characteristic signal showing a change in the morphology of the echo signal emitted by the micro-ultrasound transducer on the needle tip when encountering different tissue interfaces. All three occur simultaneously within a preset very short time period. The specific steps are as follows:

[0017] The synchronous time-domain analysis of the three signal streams specifically includes: detecting in parallel a transient change feature indicating a sudden drop in pressure from the mechanical characteristic signal, detecting a feature indicating a step change in tissue impedance from a high-resistivity state to a low-resistivity state from the electrical characteristic signal, and detecting a feature indicating a change in ultrasonic echo mode from specular reflection dominance to scattering dominance from the acoustic characteristic signal. The occurrence of the landmark event is only confirmed when the occurrence points of the above three detected features on the time axis are within a preset time synchronization window.

[0018] As a preferred embodiment of the safe and high-success-rate sternal bone marrow aspiration method of the present invention, wherein: upon identification of the landmark event, the central processing unit triggers an electromechanical actuator capable of locking and retracting the puncture needle based on the judgment result of the landmark event, thereby terminating and locking further movement of the puncture needle along its own central axis. The specific steps are as follows:

[0019] In response to confirmation of the landmark event, a brake actuator coaxially linked with the puncture needle is driven to generate a braking force opposite to the direction of propulsion to stop its movement, and a locking mechanism is then activated to fix the axial position of the puncture needle.

[0020] As a preferred embodiment of the safe and high-success-rate sternal bone marrow aspiration method of the present invention, the method includes: generating a three-dimensional anatomical model of the target puncture area based on pre-acquired patient medical imaging data, planning a target puncture path in the model, and tracking the spatial position of the puncture needle in real time during the advancement of the puncture needle, guiding the operation by indicating its current position relative to the target puncture path on the display interface. The specific steps are as follows:

[0021] The generation of the three-dimensional anatomical model also includes explicitly identifying preset risk areas in the model. The planning of the target puncture path is calculated based on the principle of avoiding the risk areas and reaching a target area within the medullary cavity. Furthermore, the guiding operation also includes dynamically predicting the forward trajectory of the puncture needle based on its real-time posture and providing a warning when the predicted trajectory interferes with the risk area. The identification of the preset risk areas is achieved by automatically segmenting the medical image data using a machine learning algorithm. The planning of the target puncture path also includes establishing a safety buffer zone around the risk area and searching for a path in the space outside the safety buffer zone according to preset optimization criteria. Moreover, the warning is triggered in stages based on the distance between the predicted forward trajectory and the risk area or its safety buffer zone.

[0022] Secondly, the present invention provides a safe and highly successful operating system for sternal bone marrow aspiration, comprising:

[0023] A puncture actuator with a multimodal sensing component, the multimodal sensing component being configured to simultaneously acquire signals of at least three different physical properties generated when the tip of the puncture needle interacts with the tissue;

[0024] An active tactile feedback module linked to the puncture actuator is capable of applying programmable, multi-dimensional force or vibration feedback to the operator's hand.

[0025] The central data fusion and control unit, electrically connected to the multimodal sensing components and the active tactile feedback module, is programmed to sequentially execute the following distinct operational steps: First, it continuously receives and fuses various physical signals from the multimodal sensing components to identify the tissue type currently in which the puncture needle tip is located in real time and deterministically, and specifically, accurately identifies tissue interface transition events from subcutaneous tissue to cortical bone and from cortical bone to medullary cavity; next, based on the real-time identification results of the tissue interface transition events, at the critical stage when the puncture needle tip is about to contact or is penetrating the cortical bone, it drives the active tactile feedback module to generate a predictive tactile warning with clear warning significance, simulating increased resistance or high-frequency vibration; finally, at the instant it is confirmed that the puncture needle tip has completely broken through the cortical bone and entered the medullary cavity, it immediately drives the active tactile feedback module to output a rigid braking force of sufficient strength to counteract the operator's conventional thrust, thereby forming an insurmountable safety barrier at the physical level and forcibly terminating any further axial advancement of the puncture needle.

[0026] Thirdly, the present invention provides a safe and highly successful operating system for sternal bone marrow aspiration, characterized in that:

[0027] The multimodal sensing component includes at least: a mechanical sensing unit for quantifying the operating force and the force on the needle tip, an acoustic sensing unit for capturing the high-frequency acoustic signals emitted when the tissue microstructure is damaged, and an electrical sensing unit for detecting the electrical specificity of the tissue contacted by the needle tip. The three sensing units of different physical dimensions are configured to work synchronously to generate a multidimensional signal combination that can reflect changes in tissue type and state.

[0028] Fourthly, the present invention provides a safe and highly successful operating system for sternal bone marrow aspiration, characterized in that:

[0029] The central data fusion and control unit is configured to: first, based on the fusion analysis of the various physical signals, identify a first combination of characteristic signals representing that the puncture needle tip has contacted and is penetrating the high-density cortical bone, and based on the identification result, drive the active tactile feedback module to output a first tactile feedback mode as a predictive warning; then, based on the fusion analysis, identify a second combination of characteristic signals representing that the puncture needle tip has broken through the cortical bone and entered the low-density medullary cavity, and based on the identification result, immediately drive the active tactile feedback module to switch to outputting a second tactile feedback mode that serves as a rigid safety boundary and is sufficient to terminate puncture advancement.

[0030] The beneficial effects of this invention are as follows: First, it fundamentally solves the core bottleneck of operational safety, achieving a qualitative leap in safety assurance. The safety of existing technologies is ultimately limited by the operator's own neural reaction speed, while this invention, by introducing a microsecond-level rigid safety braking mechanism, can absolutely and reliably terminate the puncture advance with speed and force far exceeding physiological limits the instant the puncture needle breaks through the bone cortex, even before the human brain perceives the "feeling of loss," thus transforming safety assurance from relying on passive human response to being actively guaranteed by the system.

[0031] The reason why this proactive intervention can be executed so precisely is that this invention creatively adopts a real-time fusion analysis strategy of multi-source heterogeneous physical signals. By finding feature mutations that occur simultaneously in multiple physical dimensions, it can accurately identify tissue interfaces with extremely high confidence, effectively overcoming the misjudgment problem that is easily caused by a single signal source.

[0032] Ultimately, the invention’s unique two-stage active intervention mode of predictive warning + rigid braking not only provides ultimate safety assurance, but also transforms an uncertain “blind exploration” process into a predictable, human-machine collaborative standardized process through advance tactile warnings. This greatly enhances the operator’s sense of control and trust, laying a solid technical foundation for the widespread promotion of this high-risk operation and the standardized training of physicians. Attached Figure Description

[0033] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the following description of the embodiments will be briefly introduced. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0034] Figure 1 The main flowchart for intelligent guidance and immobilization of sternal puncture.

[0035] Figure 2 Flowchart of the algorithm for safe puncture path planning.

[0036] Figure 3 This is a flowchart for multimodal signal fusion and landmark event recognition.

[0037] Figure 4 This is a flowchart of a responsive braking lockout process.

[0038] Figure 5 This is the flowchart for forward-looking risk warning as described in S6.

[0039] Figure 6 This is a schematic diagram of the overall structure of a puncture needle with multimodal sensing and rapid braking functions.

[0040] Figure 7 This is a diagram showing the distribution of the sensors at the tip of the needle. Detailed Implementation

[0041] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0042] Many specific details are set forth in the following description in order to provide a full understanding of the invention. However, the invention may also be practiced in other ways different from those described herein, and those skilled in the art can make similar extensions without departing from the spirit of the invention. Therefore, the invention is not limited to the specific embodiments disclosed below.

[0043] Secondly, the term "one embodiment" or "embodiment" as used herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation of the present invention. The phrase "in one embodiment" appearing in different places in this specification does not necessarily refer to the same embodiment, nor is it a single or selective embodiment that is mutually exclusive with other embodiments.

[0044] Example 1

[0045] Reference Figures 1-4 This is one embodiment of the present invention, which provides a safe and highly successful procedure based on sternal bone marrow aspiration, comprising the following steps:

[0046] S1. Advance a specially designed puncture needle with a sensor integrated in its tip area to detect information about different physical properties. The specific operating steps are as follows:

[0047] The specific steps for preparing and positioning the puncture needle device are as follows: Before the operation, a three-dimensional digital model of the patient's sternum is established using CT images, and an initial puncture path including the puncture target point, safety boundary, and prohibited area is planned; During the operation, a real-time three-dimensional ultrasound imaging system is used to scan the puncture area, and the real-time ultrasound images are rigidly and elastically registered with the preoperative CT model to dynamically correct the anatomical displacement caused by the patient's breathing or slight changes in body position. The fused image after registration provides real-time and accurate anatomical reference for the navigation of the puncture needle, ensuring that the puncture needle is accurately aligned with the ideal puncture window that is the thickest part of the medullary cavity and far away from key blood vessels before advancement.

[0048] It should be noted that the rigid and elastic registration of real-time ultrasound images with the preoperative CT model is performed in two steps, from coarse to fine:

[0049] Step 1: Rigid registration (overall alignment) By matching the bone surface contours that are visible in both CT and real-time ultrasound, the entire CT model is moved and rotated to the correct position and orientation in the surgical space in one go as a non-deformable whole, completing the initial macroscopic calibration;

[0050] Step 2: Flexible Registration (Dynamic Fine-tuning) Based on overall alignment, the system continuously tracks real-time deformation of soft tissues caused by factors such as the patient's breathing. Through calculation, it dynamically and locally stretches or compresses the CT model to ensure complete synchronization with the dynamic anatomical structures seen by ultrasound, achieving precise dynamic tracking.

[0051] S2. During the advancement of the puncture needle, at least three signal streams with different physical properties are acquired in real time and synchronously through a sensing device. The signal streams characterize the mechanical, electrical, and acoustic properties of the local tissue area in front of the needle tip that directly interacts with the sensor. The specific operation steps are as follows:

[0052] The specially designed puncture needle for propulsion includes the following sensing devices: a mechanical sensor integrated into the force transmission path of the puncture needle to measure the thrust along its axis; an electrical sensor disposed on the distal outer surface of the puncture needle tip in the form of a multi-electrode array to measure the bioelectrical impedance of the local tissue in front of the needle tip; and an acoustic sensor disposed at the distal end of the puncture needle to emit ultrasonic waves and receive their echo signals in the tissue.

[0053] It should be noted that the sensing device acquires comprehensive characteristic information of the tissue in front of the puncture needle tip in real time through the following three parallel and complementary physical measurement methods.

[0054] Mechanical sensor (tactile): measures the magnitude of the thrust in real time. When the needle tip breaks through hard bone, the thrust will decrease instantly, which provides the system with a clear "breakthrough" signal.

[0055] Electrical sensor (identification): measures the resistance of the tissue in front of the needle tip. Bone has a high resistance, while bone marrow has a low resistance. When the resistance value changes from high to low, it is confirmed that the needle tip has successfully entered the bone marrow cavity.

[0056] Acoustic sensor (eye): Like a miniature radar, it uses ultrasound to detect the distance between the needle tip and the tissue in front, and can see the back wall of the bone in advance to prevent punctures from being too deep.

[0057] S3. Perform real-time analysis of the three signal streams on the same time axis to identify a landmark event characterizing the penetration of the puncture needle tip from the dense cortical bone layer into the porous medullary cavity. The landmark event is defined as the mechanical characteristic signal of a significant decrease in needle tip load within a very short time, the electrical characteristic signal of a sharp decrease in bioelectrical impedance measured by the microelectrode on the needle tip within a very short time, and the acoustic characteristic signal of a change in the morphology of the echo signal emitted by the micro-ultrasound transducer on the needle tip when encountering different tissue interfaces. All three occur simultaneously within a preset very short time period. The specific operation steps are as follows:

[0058] Synchronous time-domain analysis of the three signal streams includes: detecting in parallel a transient change feature indicating a sudden drop in pressure from the mechanical characteristic signal, detecting a feature indicating a step change in tissue impedance from a high-resistivity state to a low-resistivity state from the electrical characteristic signal, and detecting a feature indicating a change in ultrasonic echo pattern from specular reflection dominance to scattering dominance from the acoustic characteristic signal. The occurrence of the landmark event is only confirmed when the occurrence points of the above three detected features on the time axis are within a preset time synchronization window.

[0059] It should be noted that, in order to achieve synchronous judgment of abrupt changes in the characteristics of mechanical, electrical, and acoustic signals, the present invention employs the following algorithm model. First, the system runs three independent feature detectors in parallel, processing the three signal streams respectively.

[0060] For mechanical signals Detect the negative peak value of its first derivative, when Record the time at this moment. ,in,

[0061] Represents thrust;

[0062] Representing force The rate of change;

[0063] When this value is positive, it means that the force is increasing (for example, the needle is penetrating harder tissue).

[0064] When this value is negative, it means that the force is decreasing (for example, the needle tip has broken through the hard layer and entered the soft tissue).

[0065] The resistance drops dramatically the moment the needle tip penetrates the bone cortex, so It will be a very large negative number;

[0066] Because of the breakthrough It is a negative number. Adding a negative sign in front of it turns it into a positive number. The size of this positive number represents how fast the force decreases. The more violently and suddenly the force decreases, the larger the positive number will be. The more gradually the force decreases, the smaller the positive number will be.

[0067] This is a pre-set threshold, representing the minimum acceptable breakthrough velocity set within the range of [100, 300] N / s. When the system detects a force drop of 25 N / s, it will ignore it because it does not exceed the minimum standard.

[0068] When the system detects a force drop of 800 N / s, it determines that a standard event has occurred because it exceeds the minimum standard.

[0069] For electrical signals (Bioelectrical impedance), detecting a step decrease in its value, when Record the time at this moment. .in,

[0070] : Represents the impedance value measured at the current time (i);

[0071] : Represents the impedance value measured at the previous time step (i-1);

[0072] This represents the current value minus the previous value, indicating how much the impedance has changed in a very short time.

[0073] This represents a negative value for a predefined threshold. The value range is -800Ω to -300Ω. Before entering the bone marrow cavity, minute changes in impedance, between -50Ω and +50Ω, are safely ignored by the system. When the needle tip enters the bone marrow cavity, the impedance value drops significantly, typically between -1000Ω and -2500Ω, at which point the system determines that a standard event has occurred.

[0074] For acoustic signals (A characteristic parameter of the echo signal, such as energy or frequency domain centroid), detect abrupt changes in its characteristics, when Record the timestamp of this moment. .in,

[0075] This represents the amplitude of the echo signal received at the current moment (i);

[0076] This represents the amplitude of the echo signal received at the previous time step (i-1);

[0077] Calculate the change in echo amplitude over a very short period of time;

[0078] The signal fluctuation before puncture is (0.5%-4%), and the signal fluctuation during puncture is (50%-90%). When the signal value is between 50%-90%, a sudden change in the characteristic is detected. This represents a pre-set amplitude change threshold.

[0079] When the system captures these three times in a short period of time , , Subsequently, the landmark event is confirmed using the following synchronicity determination formula. Did it happen:

[0080]

[0081] in:

[0082] , , These refer to the times when mechanical, electrical, and acoustic characteristic events occur, respectively.

[0083] The function calculates the maximum absolute value of the differences between any two pairs of three timestamps.

[0084] : is the preset "time synchronization window", which is a specific, extremely short time constant (for example, it can be set to 5 milliseconds depending on the system sampling rate and tissue penetration speed);

[0085] Only when the maximum difference in the times of the three events is less than or equal to Only then does the central processing unit determine that a landmark event has occurred and immediately trigger the brakes.

[0086] S4. If a landmark event is identified, the central processing unit will trigger the electromechanical actuator capable of locking and retracting the puncture needle based on the judgment result of the landmark event, thereby terminating and locking further movement of the puncture needle along its own central axis. The specific operation steps are as follows:

[0087] In response to confirmation of the landmark event, a brake actuator coaxially linked with the puncture needle is activated to generate a braking force opposite to the direction of propulsion to stop its movement, and a locking mechanism is then activated to fix the axial position of the puncture needle.

[0088] It should be noted that this driving process can be broken down into the following two steps:

[0089] Step 1: After confirming the landmark event, the central controller immediately sends a "stop" command to the brake actuator (usually a miniature motor), generating a force that is exactly opposite to the direction the doctor pushes the needle. The purpose of this force is not to pull out the needle, but to counteract the doctor's forward pushing force and the inertia of the puncture needle itself, so that the moving needle stops immediately.

[0090] Step 2: At the same time as the "stop" command is completed, the controller will send a "lock" command to the locking mechanism to completely fix the axial position of the puncture needle, so that it can neither move forward nor backward.

[0091] Furthermore, the locking mechanism is an electromagnetic pin structure, mainly comprising a miniature electromagnet, a locking pin linked to the electromagnet, and at least one annular groove on the puncture needle body.

[0092] During puncture (non-locking state): The electromagnet is de-energized, and the locking pin is separated from the groove under the action of the return spring, allowing the puncture needle to move freely axially;

[0093] When the locking command is triggered: the central controller energizes the electromagnet, which generates magnetic force to drive the locking pin to extend and embed into the annular groove of the puncture needle body. Through this mechanical engagement, the axial position of the puncture needle is rigidly fixed and cannot move forward or backward.

[0094] S5. Generate a three-dimensional anatomical model of the target puncture area based on the pre-acquired patient medical imaging data, plan a target puncture path in the model, and track the spatial position of the puncture needle in real time during the advancement of the puncture needle. Guide the operation by indicating the relative relationship between its current position and the target puncture path on the display interface. The specific operation steps are as follows:

[0095] It should be noted that the basic steps of the target puncture path planning algorithm are as follows:

[0096] Step 1: Environmental Modeling and Data Preparation

[0097] Based on the patient's CT or MRI image data, a high-precision three-dimensional anatomical model is generated, marking the effective range of the sternal medullary cavity; marking important organs and major blood vessels such as the heart, aorta, and lungs, which must never be crossed by any path; and marking the outer surface of the cortical bone of the sternum, which is the reference plane for calculating the puncture angle.

[0098] Step 2: Determine the scope

[0099] Determine the entry point range: On the 3D model, initially select an ideal puncture point, and use this as the center to define a small circular or square area as the entry point range;

[0100] Determine the target area: Within the target area of ​​the medullary cavity, define an ideal bullseye region, usually near the geometric center of the medullary cavity.

[0101] Step 3: Establish the optimization objective and cost function

[0102] Given a cost function The lower the cost, the better the path; its expression is:

[0103]

[0104] in,

[0105] : Represents any candidate puncture path being evaluated (a straight line from the skin to the bone marrow cavity);

[0106] : is a path The final total cost;

[0107] (...): These are "cost functions" that score the performance of a path on a particular aspect;

[0108] ...: These are "weighting coefficients," representing the proportion of each item in the total score; Safety cost function;

[0109] : Length cost function;

[0110] : Angular cost function;

[0111] Safety weights;

[0112] : Length weight;

[0113] Angle weighting;

[0114] Step 4: Path Search and Optimization

[0115] The system generates a large number of straight-line paths as candidates between the preset "entry point range" and "target point range". For each candidate path... Substitute into the cost function in step three Calculate its total cost and select the total cost. The shortest path

[0116] Step 5: Path Visualization and Confirmation

[0117] The optimal path (or multiple alternative paths) calculated by the algorithm will be visualized on the 3D anatomical model as virtual probes or highlighted lines. The operator can rotate and view the model from different angles and finally select one to confirm execution.

[0118] S6. The generation of the three-dimensional anatomical model also includes explicitly identifying the preset risk areas in the model. The planning of the target puncture path is calculated based on the principle of avoiding the risk areas and reaching a target area in the medullary cavity. Furthermore, the guiding operation also includes dynamically predicting the forward trajectory of the puncture needle according to its real-time posture and providing a warning when the predicted trajectory interferes with the risk area.

[0119] The identification of pre-defined risk areas is achieved through automatic segmentation of medical image data using machine learning algorithms. The planning of the target puncture path also includes establishing a safety buffer zone around the risk area, and searching for a path within the space outside this buffer zone according to pre-defined optimization criteria. Furthermore, warnings are triggered in stages based on the distance between the predicted trajectory and the risk area or its safety buffer zone. The specific operation steps are as follows:

[0120] It should be noted that after acquiring the patient's three-dimensional anatomical model and automatically segmenting risk areas (such as major blood vessels and nerves) and safety buffer areas, the system plans the puncture path by solving an optimization objective function. This path From the puncture point selected by the operator Target point within the bone marrow cavity Optimal path Is the following cost function Minimized path:

[0121]

[0122] in:

[0123] : Represents a candidate puncture path;

[0124] : This indicates the search for a cost function that makes The minimized path ;

[0125] : is a path The total length;

[0126] : is a path The angle between the sternal surface and the normal to the surface of the sternum;

[0127] : is a risk penalty item, it is related to the path It is related to the distance to the nearest risk area.

[0128] : is a preset weighting coefficient used to balance the importance of path length, puncture angle, and safety distance.

[0129] Example 2

[0130] This invention also provides a safe and highly successful operating system for sternal bone marrow aspiration, comprising:

[0131] A puncture actuator with a multimodal sensing component, wherein the multimodal sensing component is configured to simultaneously acquire signals of at least three different physical properties generated when the tip of the puncture needle interacts with the tissue;

[0132] An active tactile feedback module linked to the puncture actuator is capable of applying programmable, multi-dimensional force or vibration feedback to the operator's hand.

[0133] The central data fusion and control unit, electrically connected to the multimodal sensing components and the active tactile feedback module, is programmed to sequentially execute the following distinct operational steps: First, it continuously receives and fuses various physical signals from the multimodal sensing components to identify the current tissue type of the puncture needle tip in real time and deterministically, and specifically, accurately identifies tissue interface transition events from subcutaneous tissue to cortical bone and from cortical bone to medullary cavity; next, based on the real-time identification results of the tissue interface transition events, at the critical stage when the puncture needle tip is about to contact or is penetrating the cortical bone, it drives the active tactile feedback module to generate a predictive tactile warning with clear warning significance, simulating increased resistance or high-frequency vibration; finally, at the instant it is confirmed that the puncture needle tip has completely broken through the cortical bone and entered the medullary cavity, it immediately drives the active tactile feedback module to output a rigid braking force with sufficient strength to counteract the operator's normal thrust, thereby forming an insurmountable safety barrier at the physical level and forcibly terminating any further axial advancement of the puncture needle.

[0134] This embodiment also provides a computer device applicable to a safe and highly successful method and system for sternal bone marrow aspiration, comprising: a memory and a processor; the memory is used to store computer-executable instructions, and the processor is used to execute the computer-executable instructions to realize a safe and highly successful method and system for sternal bone marrow aspiration as proposed in the above embodiment.

[0135] The computer device can be a terminal, comprising a processor, memory, communication interface, display screen, and input devices connected via a system bus. The processor provides computing and control capabilities. The memory includes non-volatile storage media and internal memory. The non-volatile storage media stores the operating system and computer programs. The internal memory provides an environment for the operation of the operating system and computer programs stored in the non-volatile storage media. The communication interface is used for wired or wireless communication with external terminals; wireless communication can be achieved through Wi-Fi, carrier networks, NFC (Near Field Communication), or other technologies. The display screen can be an LCD screen or an e-ink screen. The input devices can be a touch layer covering the display screen, buttons, a trackball, or a touchpad on the computer device's casing, or an external keyboard, touchpad, or mouse.

[0136] This embodiment also provides a storage medium storing a computer program, which, when executed by a processor, implements a safe and highly successful sternal bone marrow aspiration method and system as described in the above embodiments. The storage medium can be implemented by any type of volatile or non-volatile storage device or a combination thereof, such as Static Random Access Memory (SRAM), Electrically Erasable Programmable Read-Only Memory (EEPROM), Erasable Programmable Read-Only Memory (EPROM), Programmable Red-Only Memory (PROM), Read-Only Memory (ROM), magnetic storage, flash memory, magnetic disk, or optical disk.

[0137] Example 3

[0138] Reference Figure 6 and Figure 7 In one embodiment of the present invention, a puncture needle with multimodal sensing and rapid braking function is provided. This puncture needle with multimodal sensing and rapid braking function includes a handheld housing 101, the handheld housing 101 having a puncture needle channel 103 inside; a puncture needle 102, the puncture needle 102 being slidably housed in the puncture needle channel 103 and capable of reciprocating along its own axis, and the handle of the puncture needle 102 having a push rod 104 for applying axial thrust.

[0139] The feature is that: a multimodal sensing probe 105 is provided at the rear end of the needle tip of the puncture needle 102, the multimodal sensing probe 105 includes a mechanical sensing probe 105a, an acoustic sensing probe 105b and an electrical sensing probe 105c; a return spring 106 is provided between the handheld housing 101 and the push rod 104, a wedge-shaped brake block 107 is fixedly installed on the push rod 104, the wedge-shaped brake block 107 is connected to an annular electromagnet 109 through a connecting rod 108, and the through hole of the annular electromagnet 109 is slidably sleeved on the external, static brake guide rail 110.

[0140] During operation, the handheld casing 101 is aligned with the puncture area and fixed to the external fixation device. During fixation, the annular electromagnet 109 is passed through the braking guide rail 110 on the external fixation device, and the puncture needle 102 in the puncture needle channel 103 is aligned with the puncture point. In the non-braking state, the annular electromagnet 109 is not energized and can slide freely on the braking guide rail 110. When the physician pushes the push rod 104, the connected wedge-shaped brake block 107, connecting rod 108, and annular electromagnet 109 move forward and backward as a whole with the push rod 104. By pushing the push rod 104 on the handle of the puncture needle 102, the physician applies an axial force to the puncture needle 102. Subsequently, the return spring 106 is gradually compressed, storing elastic potential energy in the process, while providing the operator with a gradual and perceptible resistance feedback. The puncture needle 102 is advanced along the puncture needle channel 103. During the puncture process, when the mechanical sensor 105a of the multimodal sensor probe 105 identifies and transmits a mechanical signal, the acoustic sensor 105b identifies and transmits an acoustic signal, and the electrical sensor 105c identifies and transmits an electrical signal, the central processing unit immediately supplies current to the annular electromagnet 109 after recognizing the landmark event. The annular electromagnet 109 is instantaneously energized, generating a strong magnetic force, which electromagnetically locks the annular electromagnet 109 to the stationary brake rail 110, turning the originally sliding annular electromagnet 109 into a rigid locking point fixed to the handheld housing 101. Since this rigid locking point is connected to the wedge-shaped brake block 107 through the connecting rod 108, the position of the wedge-shaped brake block 107 is also fixed. Ultimately, because the wedge-shaped brake block 107 is mounted on the push rod 104, the movement of the push rod 104 is forcibly terminated, thereby achieving a fast and reliable braking lock on the entire puncture needle 102.

[0141] In summary, compared with existing technologies, the benefits of this invention are revolutionary. Firstly, it fundamentally solves the core bottleneck of operational safety, achieving a qualitative leap in safety assurance. The safety of existing technologies is ultimately limited by the operator's own neural reaction speed. However, this invention, by introducing a microsecond-level rigid safety braking mechanism, can absolutely and reliably terminate the puncture advance with speed and force far exceeding physiological limits the instant the puncture needle penetrates the bone cortex, even before the human brain perceives the "loss of sensation." This transforms safety assurance from relying on passive human response to being actively guaranteed by the system. The reason this active intervention can be executed so precisely is that this invention creatively employs a real-time fusion analysis strategy of multi-source heterogeneous physical signals. By searching for feature mutations occurring simultaneously in multiple physical dimensions, it can accurately identify tissue interfaces with extremely high confidence, effectively overcoming the misjudgment problem easily caused by a single signal source. Ultimately, the invention’s unique two-stage active intervention mode of predictive warning + rigid braking not only provides ultimate safety assurance, but also transforms an uncertain “blind exploration” process into a predictable, human-machine collaborative standardized process through advance tactile warnings. This greatly enhances the operator’s sense of control and trust, laying a solid technical foundation for the widespread promotion of this high-risk operation and the standardized training of physicians.

[0142] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A safe and high success rate method of performing a sternal bone marrow aspiration, comprising: The method comprises the following steps: S1, advancing a specially designed puncture needle integrated with sensing devices for sensing different physical property information at the needle tip region; S2, during the advancement of the puncture needle, synchronously acquiring at least three different physical property signal streams in real time by the sensing devices, the signal streams respectively representing the mechanical, electrical and acoustic properties of the local tissue region in front of the needle tip directly interacting with the sensors; S3, performing real-time analysis of the three signal streams on the same time axis to identify a landmark event representing the puncture needle tip breaking through the dense cortical bone layer into the loose bone marrow cavity; S4, the landmark event is defined as the mechanical property signal of the needle tip load sharply decreasing in a very short time, the electrical property signal of the bioelectrical impedance value measured by the microelectrode on the needle tip sharply decreasing in a very short time, and the acoustic property signal of the micro ultrasonic transducer on the needle tip emitting sound waves and the echo signal pattern features changing when encountering different tissue interfaces, all occurring simultaneously within a preset very short time period; S5, upon identifying the landmark event, triggering the electromechanical execution device capable of locking and retracting the puncture needle according to the judgment result of the landmark event to terminate and lock the further movement of the puncture needle along its own central axis direction.

2. A safe and high success rate method of performing sternal bone marrow puncture as claimed in claim 1, wherein: The specially designed puncture needle comprises a mechanical sensor integrated in the force transmission path of the puncture needle to measure the thrust force along its axis direction for acquiring the mechanical property signal, a multi-electrode array arranged on the outer surface of the distal end of the needle tip of the puncture needle to measure the bioelectrical impedance of the local tissue in front of the needle tip for acquiring the electrical property signal, and an acoustic sensor arranged at the distal end of the puncture needle to emit ultrasonic waves and receive the echo signals in the tissue for acquiring the acoustic property signal.

3. A safe and high success rate method of performing sternal bone marrow puncture as claimed in claim 2, wherein: The synchronous time domain analysis of the three signal streams specifically includes: detecting a transient change feature indicating pressure drop from the mechanical property signal, detecting a feature indicating the step change of tissue impedance value from high resistance state to low resistance state from the electrical property signal, and detecting a feature indicating the ultrasonic echo mode changing from mirror reflection dominated to scattering dominated from the acoustic property signal, and only when the occurrence points of the above three detected features on the time axis are within a preset time synchronization window, the occurrence of the landmark event is finally confirmed.

4. The safe and highly successful method for sternal bone marrow aspiration as described in claim 1, characterized in that: In response to the confirmation of the landmark event, a brake actuator coaxially linked with the puncture needle is driven to generate a braking force opposite to the advancement direction to stop the movement, and then a locking mechanism is started to fix the axial position of the puncture needle.

5. The safe and highly successful method for sternal bone marrow aspiration as described in claim 4, characterized in that: Based on pre-acquired patient medical image data, a three-dimensional anatomical model of a target puncture region is generated, and a target puncture path is planned in the model. During the advancement of a puncture needle, the spatial position of the puncture needle is tracked in real time, and the operation is guided by indicating the relative relationship between the current position of the puncture needle and the target puncture path on a display interface.

6. The method of claim 5, wherein the method further comprises: The generation of the three-dimensional anatomical model further includes explicitly identifying a preset risk region in the model. The planning of the target puncture path is calculated based on the principle of avoiding the risk region and reaching a target region in the bone marrow cavity. The guiding operation further includes dynamically predicting the advancing trajectory of the puncture needle according to the real-time posture of the puncture needle, and providing a warning when the predicted trajectory interferes with the risk region.

7. The safe and highly successful method for sternal bone marrow aspiration as described in claim 6, characterized in that: The identification of the preset risk region is achieved by automatically segmenting the medical image data through a machine learning algorithm. The planning of the target puncture path further includes establishing a safe buffer region around the risk region, and searching for a path in the space outside the safe buffer region according to a preset optimization criterion. The warning is triggered according to the distance between the predicted advancing trajectory and the risk region or its safe buffer region.

8. A safe and high success rate operating system for sternal bone marrow puncture, based on the safe and high success rate operating method for sternal bone marrow puncture according to any one of claims 1 to 7, characterized in that: Comprise: a puncture executor with a multi-modal sensing assembly configured to synchronously collect signals of at least three different physical properties generated when a puncture needle tip interacts with tissue; an active haptic feedback module linked with the puncture executor, capable of applying programmable controlled, multi-dimensional force or vibration feedback to the operator's hand; a central data fusion and control unit electrically connected with the multi-modal sensing assembly and the active haptic feedback module, and programmed to sequentially perform the following explicitly distinguished operation steps: first, continuously receive and fuse analysis of multiple physical signals from the multi-modal sensing assembly to identify the type of tissue currently present at the puncture needle tip in real time and with certainty, and accurately identify the tissue interface transition event from subcutaneous tissue to bone cortex and from bone cortex to bone marrow cavity; then, based on the real-time identification result of the tissue interface transition event, drive the active haptic feedback module to generate a predictive haptic warning with clear warning significance, such as simulated increased resistance or high-frequency vibration, at the critical stage when the puncture needle tip is about to contact or is penetrating the bone cortex; finally, immediately drive the active haptic feedback module to output a transiently generated rigid braking force strong enough to resist the regular pushing force of the operator, thereby forming an insurmountable safety barrier at the physical level and forcibly terminating any further axial advancement of the puncture needle, when the puncture needle tip is accurately identified as having completely broken through the bone cortex and entered the bone marrow cavity.

9. The safe high success rate sternum marrow puncture operation system according to claim 8, characterized in that: The multi-modal sensing assembly comprises at least: a mechanical sensing unit for quantifying the operation force and the force on the needle tip, an acoustic sensing unit for capturing the high-frequency acoustic signals emitted when the microstructure of the tissue is damaged, and an electrical sensing unit for detecting the electrical specificity of the tissue contacted by the needle tip, wherein the three different physical dimension sensing units are configured to work synchronously to generate a multi-dimensional signal combination that can reflect the type and state change of the tissue.

10. The safe high success rate sternum bone marrow aspiration procedure system of claim 9, wherein: The central data fusion and control unit is configured to: first, based on the fusion analysis of the multiple physical signals, identify a first characteristic signal combination representing that the needle tip has contacted and is penetrating the high-density cortical bone, and based on the identification result, drive the active haptic feedback module to output a first haptic feedback mode as a predictive warning; then, continue to identify a second characteristic signal combination representing that the needle tip has broken through the cortical bone and entered the low-density bone marrow cavity based on the fusion analysis, and based on the identification result, immediately drive the active haptic feedback module to switch to output a second haptic feedback mode as a rigid safety boundary, which is sufficient to terminate the puncture advancement.

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