Cerebral hemorrhage residual hematoma spatial perception and safe aspiration catheter system

Abstract

The embodiment of the specification relates to the technical field of medical instruments, in particular to a brain hemorrhage residual hematoma space perception and safe suction catheter system. The system comprises: a catheter body, the distal end of which is used for being placed in an intracranial hematoma cavity; an ultrasonic detection unit arranged in a distal end working area of the catheter body, used for acquiring ultrasonic detection information of the tissue around the distal end working area of the catheter body; a pose perception unit arranged in a tail end working area of the catheter body, used for acquiring pose change information of the catheter; a data coupling processing unit, used for constructing a residual hematoma local boundary model and determining the relative position of the catheter body in the model based on the ultrasonic detection information and the corresponding pose change information at each sampling time; and an output unit, used for outputting suction decision information according to the residual hematoma local boundary model and the relative position. The application can effectively improve the suction safety and hematoma removal efficiency.

Description

Technical Field

[0001] The embodiments in this specification relate to the field of medical device technology, and in particular to a spatial sensing and safe aspiration catheter system for residual hematoma in cerebral hemorrhage. Background Technology

[0002] Intracerebral hemorrhage is one of the most common acute and critical conditions in neurosurgery. For patients suitable for surgical intervention, clinical treatment often employs methods such as stereotactic puncture, minimally invasive catheter drainage, hematoma aspiration and evacuation, and neuroendoscopic-assisted evacuation. Minimally invasive catheterization has become a crucial technique in the treatment of intracerebral hemorrhage due to its advantages of less trauma, shorter path, and rapid access to the hematoma cavity. During the aspiration and evacuation phase after catheter placement, accurately determining the boundary morphology of the residual hematoma and the relative position of the catheter is a core prerequisite for balancing hematoma evacuation efficiency and avoiding the risks of aspiration and rebleeding of brain tissue.

[0003] Existing technologies include ultrasound catheters, position / angle acquisition, and even image reconstruction. However, their functions are mostly focused on forward detection and improving puncture accuracy during the puncture phase. They cannot continuously and dynamically perceive the spatial morphology of the residual hematoma after the catheter has entered the hematoma cavity. Furthermore, existing technologies cannot clearly define the relative position of the catheter within the hematoma cavity; the operator (or surgeon) still needs to rely on preoperative imaging, puncture depth, and operational experience to determine the aspiration range and the timing of cessation.

[0004] In summary, existing technologies lack real-time awareness of the boundaries of residual hematoma during the aspiration process, cannot determine the relative position of the catheter within the hematoma cavity, and cannot accurately output aspiration decision information, resulting in insufficient aspiration safety and limited hematoma clearance efficiency.

[0005] There is currently no effective solution to the above problems. Summary of the Invention

[0006] The purpose of the embodiments in this specification is to provide a spatial perception and safe aspiration catheter system for residual hematoma in cerebral hemorrhage, in order to solve the technical problems of existing technologies that lack real-time awareness of the boundary of residual hematoma during the aspiration process, cannot determine the relative position of the catheter in the hematoma cavity, and cannot accurately output aspiration decision information, thereby resulting in insufficient aspiration safety and limited hematoma clearance efficiency.

[0007] In a first aspect, embodiments of this specification provide a spatial sensing and safe aspiration catheter system for residual hematoma in cerebral hemorrhage, comprising: The catheter body, the distal working area of ​​which is used for placement in the hematoma cavity; An ultrasound detection unit is located in the distal working area of ​​the catheter body to acquire ultrasound detection information of the tissue surrounding the distal working area of ​​the catheter body. The pose sensing unit is located in the working area at the tail end of the catheter body and is used to acquire pose change information of the catheter. A data coupling processing unit, connected to the ultrasound detection unit and the pose sensing unit, is used to construct a local boundary model of the residual hematoma based on the ultrasound detection information and the corresponding pose change information at each sampling time, and to determine the relative position of the catheter body in the local boundary model of the residual hematoma. The output unit, connected to the data coupling processing unit, is used to output aspiration decision information based on the local boundary model of the residual hematoma and the relative position.

[0008] In one embodiment, the ultrasound detection information includes at least one of the following: echo amplitude information, echo envelope characteristics, echo delay, boundary abrupt change characteristics, and detection direction; the pose change information includes at least one of the following: the rotation angle information of the catheter around its own axis and the forward and backward displacement information along its own axis; and the aspiration decision information includes at least one of the following: recommended aspiration direction, danger direction warning, and aspiration control signal.

[0009] In one embodiment, the catheter body is provided with a suction channel, and the distal working area of ​​the catheter body is provided with at least one suction port. The suction port is used to draw the contents of the hematoma cavity into the suction channel and discharge them out of the body under the action of suction negative pressure. The relative positional relationship between the suction port and the ultrasonic detection unit includes one of the following: A suction port is arranged parallel to and in the same direction as an ultrasonic detection unit; or A suction port is combined with multiple ultrasonic detection units, which are arranged in a circular pattern with equal angles.

[0010] In one embodiment, constructing a local boundary model of the residual hematoma based on the ultrasound detection information and corresponding pose change information at each sampling time includes: Based on the ultrasound detection information, the distance of the hematoma boundary at each sampling time is determined; Spatial registration is performed between the hematoma boundary distance at each sampling time and the corresponding pose change information to obtain boundary sampling points with spatial coordinates; Boundary sampling points with spatial coordinates obtained at multiple different sampling times are spatially accumulated to form a boundary point cloud. The boundary point cloud is then fitted with a surface to construct a local boundary model of the residual hematoma.

[0011] In one embodiment, determining the hematoma boundary distance at each sampling time based on the ultrasound detection information includes: The ultrasonic detection information is subjected to bandpass filtering and envelope detection to obtain the echo envelope signal; A sliding time window analysis is performed on the echo envelope signal. When at least one of the following features is detected: a decrease in echo envelope amplitude, an increase in the spacing between adjacent reflection peaks, or an interruption in echo continuity, it is determined that a characteristic echo gap appears at the target sampling time. The characteristic echo gap represents the ultrasound signal propagation path reaching the hematoma boundary. The distance to the hematoma boundary at the target sampling time is determined based on the flight time and the average sound velocity of brain tissue corresponding to the characteristic echo gap at the target sampling time.

[0012] In one embodiment, the step of spatially registering the hematoma boundary distance at each sampling time with the corresponding pose change information to obtain boundary sampling points with spatial coordinates includes: A rotation matrix is ​​constructed based on the rotation angle information in the pose change information corresponding to the target sampling time, and a translation vector is constructed based on the forward and backward displacement information in the pose change information corresponding to the target sampling time. The transformation matrix of the target sampling time is composed of the rotation matrix and the translation vector. Obtain the fixed position of the ultrasound detection unit in the catheter coordinate system at the target sampling time, and the unit vector of the detection direction in the catheter coordinate system at the target sampling time; Based on the hematoma boundary distance at the target sampling time, the fixed position of the ultrasound detection unit in the catheter coordinate system, and the unit vector, calculate the position of the boundary sampling point in the catheter coordinate system at the target sampling time. By using the transformation matrix of the target sampling time, the position of the boundary sampling point at the target sampling time in the catheter coordinate system is mapped to the global reference system, forming the boundary sampling point with spatial coordinates at the target sampling time. The global reference system is the coordinate system corresponding to the initial pose of the catheter body.

[0013] In one embodiment, the step of performing surface fitting on the boundary point cloud to construct a local boundary model of the residual hematoma includes: The boundary point cloud is filtered to remove boundary point clouds with confidence scores lower than a preset confidence threshold. The filtered boundary point clouds are classified into hematoma boundary point clouds, brain tissue boundary point clouds, and junctional area point clouds according to the tissue type label. The point cloud of the hematoma boundary is fitted with a surface to obtain the local boundary surface of the residual hematoma, which serves as the local boundary model of the residual hematoma.

[0014] In one embodiment, determining the relative position of the catheter body within the local boundary model of the residual hematoma includes: Obtain the transformation matrix corresponding to the current pose of the catheter body; Obtain the fixed position of the distal working area of ​​the catheter body in the catheter coordinate system. Through the transformation matrix corresponding to the current pose, map the fixed position of the distal working area of ​​the catheter body in the catheter coordinate system to the global reference system to obtain the position of the distal working area of ​​the catheter body in the global reference system. Calculate the distance from the position of the distal working area of ​​the catheter body in the global reference frame to the target distance of the local boundary model of the residual hematoma; Based on the comparison between the target distance and the preset distance threshold, the region where the catheter body is located in the local boundary model of the residual hematoma is determined as the relative position.

[0015] In one embodiment, the preset distance threshold includes a first preset distance threshold and a second preset distance threshold; correspondingly, determining the region where the catheter body is located in the local boundary model of the residual hematoma based on the comparison result of the target distance and the preset distance threshold includes: When the target distance is greater than a first preset distance threshold, it is determined that the catheter body is located in the hematoma center area; When the second preset distance threshold is less than the target distance and the target distance is less than or equal to the first preset distance threshold, it is determined that the catheter body is in the hematoma edge area; When the target distance is less than or equal to the second preset distance threshold, the catheter body is determined to be in a high-risk contact zone; wherein the first preset distance threshold is greater than the second preset distance threshold.

[0016] In one embodiment, the output unit is configured to output aspiration decision information based on the local boundary model of the residual hematoma and the relative position, including: The safety aspiration level is determined based on the region where the catheter body is located in the local boundary model of the residual hematoma. Centered on the position of the distal working area of ​​the catheter body in the global reference frame, multiple directions are traversed in the vertical plane of the catheter body axis. For each direction angle, the boundary distance from the position of the distal working area of ​​the catheter body in the global reference frame along the target direction to the local boundary model of the residual hematoma is calculated. Based on the safety suction level and the boundary distance, suction decision information is output.

[0017] In one embodiment, outputting suction decision information based on the safety suction level and the boundary distance includes: When the safety suction level is high, the target direction with a boundary distance greater than or equal to a preset safety distance threshold is determined as the recommended suction direction, and the target direction with a boundary distance less than the preset safety distance threshold is determined as the dangerous direction, and a first-level dangerous direction warning is output. When the safety aspiration level is medium, an alert is output for approaching the hematoma boundary, and the target direction where the boundary distance is less than the preset safety distance threshold is determined as the danger direction, and a level two danger direction alert is output. When the safety aspiration level is low, an emergency warning is issued for approaching brain tissue, and a control signal to stop aspiration is also issued.

[0018] In one embodiment, the system further includes a suction control unit and a negative pressure source. The suction control unit is connected to the output unit and the negative pressure source respectively, and is used to receive the suction control signal output by the output unit and control the negative pressure source according to the suction control signal to adjust the suction negative pressure at the suction port.

[0019] In one embodiment, the suction control unit is configured to perform one or more of the following control actions according to the suction control signal: When the catheter body is in the center of the hematoma and the current aspiration direction is consistent with the recommended aspiration direction, the negative pressure source is controlled to maintain or increase the aspiration negative pressure. When the catheter body is in the hematoma edge area or the current aspiration direction is judged to be a dangerous direction, the negative pressure source is controlled to gradually reduce the aspiration negative pressure to a preset safe negative pressure threshold. When the output approaches the brain tissue emergency warning, the negative pressure source is controlled to suspend suction. When the signal indicating that the hematoma has been cleared is output, the negative pressure source is controlled to stop suction.

[0020] In one embodiment, the system further includes an auxiliary sensing unit, and the data coupling processing unit is further configured to fuse the auxiliary information collected by the auxiliary sensing unit with the ultrasonic detection information and pose change information to correct the spatial coordinates of the boundary sampling points.

[0021] This specification provides a spatial perception and safe aspiration catheter system for residual hematoma in cerebral hemorrhage. By placing the distal end of the catheter body within the hematoma cavity and installing an ultrasound detection unit in its distal working area, continuous, real-time, and in-situ detection of the catheter within the hematoma cavity is achieved, reflecting the dynamic boundary changes during hematoma aspiration. A data coupling processing unit constructs a local boundary model of the residual hematoma based on the ultrasound detection results and corresponding pose changes at each sampling moment, achieving a leap from "single-point distance measurement" to "spatial model construction," enabling continuous and dynamic perception of the spatial morphology of the residual hematoma. Further determination of the catheter's relative position within the boundary model clarifies its position within the hematoma cavity, providing the operator with objective spatial location judgment information. The output unit outputs aspiration decision information based on the local boundary model and relative position of the residual hematoma, transforming the abstract local boundary model into concrete aspiration decision information, providing the operator with accurate aspiration decision-making information. The above solution solves the technical problems of existing technologies, such as lack of real-time awareness of residual hematoma boundaries, inability to determine the relative position of the catheter in the hematoma cavity, and inability to accurately output aspiration decision information, which leads to insufficient aspiration safety and limited hematoma clearance efficiency. It achieves a leap from single-point detection to spatial awareness, transforming hematoma aspiration from blind operation relying on experience to precise guidance under spatial perception, thereby improving aspiration safety and hematoma clearance efficiency. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments or prior art of this specification, the drawings used in the description of the embodiments or prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this specification. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This is a schematic diagram of the structural composition of a spatial sensing and safe aspiration catheter system for residual hematoma in cerebral hemorrhage provided in the embodiments of this specification; Figure 2 This is a functional structural diagram of a spatial sensing and safe aspiration catheter system for residual hematoma in cerebral hemorrhage provided in the embodiments of this specification; Figure 3 This is a schematic diagram illustrating the relative positional relationship between the suction port and the ultrasonic detection unit provided in the embodiments of this specification; Figure 4 This is another schematic diagram showing the relative positional relationship between the suction port and the ultrasonic detection unit provided in the embodiments of this specification; Figure 5This is a schematic diagram of the overall structure of a spatial perception and safe aspiration catheter system for residual hematoma in cerebral hemorrhage, provided in the embodiments of this specification.

[0024] Explanation of reference numerals in the attached figures: 1. Catheter body; 2. Ultrasonic detection unit; 3. Position sensing unit; 4. Connecting wire; 5. Aspiration port. Detailed Implementation

[0025] The technical solutions in the embodiments of this specification will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this specification, and not all embodiments. Based on the embodiments in this specification, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of this specification.

[0026] As mentioned earlier, intracerebral hemorrhage is one of the common acute and critical illnesses in neurosurgery. For patients suitable for surgical intervention, clinical treatment often employs methods such as stereotactic puncture, minimally invasive catheter drainage, hematoma aspiration and evacuation, and neuroendoscopic-assisted evacuation. Minimally invasive catheterization has advantages such as less trauma, shorter path, and easy and rapid access to the hematoma cavity, and has become one of the important technical approaches in the treatment of intracerebral hemorrhage.

[0027] However, after the catheter actually enters the hematoma cavity, the following problems still exist in the hematoma removal stage: 1. Lack of real-time awareness of the boundaries of residual hematoma during the aspiration process. Operators typically rely on experience such as preoperative imaging, puncture depth, aspiration feel, and the condition of the aspirate to determine the current location of the catheter and the extent of the remaining hematoma, lacking continuous and real-time boundary feedback on the catheter's position.

[0028] 2. The boundaries of aspiration depend on experience, and there is a risk of aspirating brain tissue and rebleeding.

[0029] When aspiration reaches the area where the hematoma meets the brain tissue, blindly continuing aspiration based on experience may result in the accidental aspiration of normal brain tissue, causing damage to neurological function, or even irritating the fragile blood vessels around the hematoma cavity, leading to intraoperative or postoperative rebleeding.

[0030] 3. Excessive conservative suction will reduce the removal efficiency.

[0031] To avoid aspiration of brain tissue, operators often adopt a more conservative aspiration strategy, resulting in more residual hematoma. This requires further drainage using thrombolytic drugs such as urokinase and rt-PA, which in turn prolongs the treatment cycle, increases the need for repeated injections, and raises the risk of infection.

[0032] 4. Existing visualization and general forward probing schemes are still insufficient to solve the intracavitary aspiration decision problem.

[0033] Miniature cameras or endoscopes have limited field of vision in turbid blood environments; existing intracranial drainage catheters with built-in ultrasound solutions are more geared towards forward detection or enhanced puncture precision during the puncture stage, and cannot provide continuous spatial awareness of the residual hematoma morphology and the relative position of the catheter when the catheter is already in the hematoma cavity, and directly serve to control the aspiration boundary.

[0034] 5. The existing overarching concept of "ultrasound catheter + position / angle information" cannot directly solve the problem of intraoperative aspiration decision-making if it is only used for routine sonographic reconstruction or puncture localization.

[0035] Among the existing advanced technologies, there are ideas for ultrasound catheters, position / angle acquisition, and even image reconstruction. However, if the technical goals remain at "pre-puncture localization," "general imaging," or "forward navigation," the problem of "how to know where in the hematoma after the catheter has entered the hematoma cavity, where else can it be aspirated, and when should it be stopped" cannot be solved.

[0036] In summary, the main shortcomings of existing technologies can be summarized as follows: 1. Lack of dynamic understanding of the boundary of residual hematoma after catheter placement; 2. Inability to clearly define the relative position of the catheter in the hematoma cavity; 3. The direction of aspiration and the timing of cessation mainly rely on experience and lack objective basis; 4. Ordinary imaging, forward probing, or single-point boundary recognition schemes have not yet formed a closed loop of "intracavitary sampling - spatial reconstruction - aspiration decision"; 5. Difficulty in achieving a balance between miniaturization, low cost, and intraoperative operability.

[0037] To address the aforementioned issues, a novel catheter-level spatial sensing solution is needed clinically. This solution would enable the catheter to not only detect local boundaries within the hematoma cavity but also, by incorporating catheter pose changes, recognize the relative position of the residual hematoma boundary and the catheter, thereby guiding safe aspiration. Specifically, this specification provides a spatial sensing and safe aspiration catheter system for residual hematoma in cerebral hemorrhage. An ultrasound detection unit performs continuous, real-time in-situ detection within the hematoma cavity. Combined with the catheter pose change information acquired by the pose sensing unit, a data coupling processing unit constructs a local boundary model of the residual hematoma and determines the relative position of the catheter within this model. This achieves dynamic modeling of the residual hematoma boundary and recognition of the catheter's position relative to the hematoma during aspiration. An output unit outputs aspiration decision information based on the local boundary model of the residual hematoma and the relative position of the catheter within it. This enables safe aspiration control, transforming hematoma aspiration from experience-based blind operation to precise guidance under spatial sensing, thus improving aspiration safety and hematoma clearance efficiency. The above solution forms a complete closed loop of "dynamic modeling of residual hematoma boundary during aspiration + catheter relative hematoma position recognition + safe aspiration control". It solves the technical problems in the existing technology that lack real-time recognition of residual hematoma boundary during aspiration, cannot determine the relative position of the catheter in the hematoma cavity, and cannot accurately output aspiration decision information, thus resulting in insufficient aspiration safety and limited hematoma clearance efficiency.

[0038] It should be noted that the information and data related to users involved in the embodiments of this specification are all information and data authorized by the user or fully authorized by the relevant parties. Furthermore, the collection, storage, use, processing, transmission, provision, disclosure, and application of the relevant data all comply with relevant laws, regulations, and standards, and necessary confidentiality measures have been taken. They do not violate public order and good morals, and corresponding operation entry points are provided for users or relevant parties to choose to authorize or refuse.

[0039] It should also be noted that in the embodiments of this specification, certain software, components, models and other existing solutions in the industry may be mentioned. These should be regarded as exemplary and are only intended to illustrate the feasibility of implementing the technical solution of this application. However, it does not mean that the applicant has used or necessarily used the solution.

[0040] See Figure 1 As shown in the embodiments of this specification, a spatial sensing and safe aspiration catheter system for residual hematoma in cerebral hemorrhage is provided, which may include the following: The catheter body, the distal working area of ​​which is used for placement in the hematoma cavity; An ultrasound detection unit is located in the distal working area of ​​the catheter body to acquire ultrasound detection information of the tissue surrounding the distal working area of ​​the catheter body. The pose sensing unit is located in the working area at the tail end of the catheter body and is used to acquire pose change information of the catheter. A data coupling processing unit, connected to the ultrasound detection unit and the pose sensing unit, is used to construct a local boundary model of the residual hematoma based on the ultrasound detection information and the corresponding pose change information at each sampling time, and to determine the relative position of the catheter body in the local boundary model of the residual hematoma. The output unit, connected to the data coupling processing unit, is used to output aspiration decision information based on the local boundary model of the residual hematoma and the relative position.

[0041] In some embodiments, the ultrasound detection information may include at least one of the following: echo amplitude information, echo envelope characteristics, echo delay, boundary abrupt change characteristics, and detection direction; the pose change information may include at least one of the following: the rotation angle information of the catheter around its own axis and the forward and backward displacement information along its own axis; and the aspiration decision information may include at least one of the following: recommended aspiration direction, danger direction warning, and aspiration control signal.

[0042] Specifically, the aforementioned system may include at least a catheter body, an ultrasonic detection unit, a pose sensing unit, a data coupling processing unit, and an output unit.

[0043] The catheter body can be a flexible, semi-flexible, or slender tubular structure with a certain degree of supporting rigidity, and can be used to enter the intracranial hematoma cavity through a predetermined minimally invasive channel to perform aspiration operations. The catheter body may include a distal working area (or distal working segment), a middle connecting segment, and a proximal interface segment or a tail working area (or tail operating segment). The distal working area can be used to enter the hematoma cavity and complete aspiration and boundary detection. The tail working area can be used by the operator (such as a doctor) to perform axial rotation, advancement, retraction, and other operations, and can accommodate a pose sensing unit.

[0044] The aforementioned ultrasonic detection unit can be used to transmit ultrasonic signals to the tissue surrounding the distal working area of ​​the catheter body and receive echo signals to obtain ultrasonic detection information of the tissue surrounding the distal working area of ​​the catheter body. The ultrasonic detection information may include, but is not limited to: echo amplitude information (which can reflect the reflection intensity of the surrounding tissue interface), echo envelope characteristics (which can reflect the trend of echo energy change over time), echo delay (which can reflect the depth position of the surrounding tissue interface), boundary abrupt change characteristics (which can reflect the location of acoustic impedance changes at the surrounding tissue boundary), and detection direction (which can be determined by the fixed installation orientation of the ultrasonic detection unit). It may also include other acoustic characteristics used for interface identification.

[0045] The primary function of the ultrasound detection unit is not to generate conventional large-area imaging, but rather to detect hematoma boundaries, the proximity of brain tissue, and the contours of local residual cavities. Its forms may include, but are not limited to: piezoelectric ultrasonic transducers, PMUTs (piezoelectric micromechanical ultrasonic transducers), CMUTs (capacitive micromechanical ultrasonic transducers), miniature PZT transducers, unit-type line-scan probes, and other miniature ultrasonic transmitting / receiving components suitable for catheter miniaturization and integration. The ultrasound detection unit can be located in the distal working area of ​​the catheter body, and its specific location may include, but is not limited to: the distal end face of the catheter body, the area adjacent to the aspiration port, inside the catheter wall, or distributed circumferentially along the distal end of the catheter.

[0046] The aforementioned pose sensing unit can be located in the tail working area or proximal interface section of the catheter body and can be used to acquire pose change information of the catheter. Pose change information may include, but is not limited to, the rotation angle information of the catheter around its own axis and the forward and backward displacement information along its own axis. It may also include: the retraction displacement of the catheter along its own axis, the current operating posture of the catheter, and the relative pose change between different sampling times.

[0047] The pose sensing unit may include, but is not limited to: a miniature gyroscope, an IMU (inertial measurement unit), an angle sensor, a position sensor, a displacement sensing component, and a forward / reverse distance acquisition structure that works in conjunction with an insertion depth scale, a slider, a limit mechanism, or an external displacement detection mechanism. By acquiring the rotation angle of the guide tube around its own axis and the forward / reverse displacement along its own axis, the pose sensing unit can provide pose data for spatial registration of the subsequent data coupling processing unit.

[0048] The aforementioned data coupling processing unit can be connected to the ultrasound detection unit and the pose sensing unit. It can be used to construct a local boundary model of the residual hematoma based on the ultrasound detection information and corresponding pose change information at each sampling time, and to determine the relative position of the catheter body within the local boundary model of the residual hematoma. The processing steps include: acquiring the ultrasound detection information at the target sampling time; acquiring the pose change information corresponding to the target sampling time; mapping the ultrasound detection information at the target sampling time to boundary sampling points with spatial coordinates; accumulating the boundary sampling points obtained from multiple different sampling times to form a boundary point cloud; performing surface fitting on the boundary point cloud to construct a local boundary model of the residual hematoma; and determining the relative position of the catheter body within the local boundary model of the residual hematoma based on the current pose of the catheter body. The target sampling time can be any current sampling time. In actual implementation, each sampling time is processed sequentially as the target sampling time. The data coupling processing unit can spatially register its ultrasound detection information with the corresponding pose change information to obtain the boundary sampling points with spatial coordinates corresponding to that sampling time.

[0049] The aforementioned residual hematoma local boundary model can output the following information: the direction of the hematoma surrounding the catheter, the direction of the approach to brain tissue, the approximate morphology of the residual hematoma area, and the determination of whether the catheter is located in the central, peripheral, or high-risk contact area of ​​the hematoma. Through this residual hematoma local boundary model, the operator can intuitively understand the spatial distribution of the residual hematoma and the relative position of the catheter body within it.

[0050] The aforementioned output unit can be connected to the data coupling processing unit and can be used to output aspiration decision information based on the relative positions of the residual hematoma local boundary model and the catheter body within the residual hematoma local boundary model. The aspiration decision information may include, but is not limited to: recommended aspiration direction (suggesting the operator aspirate in this direction), danger direction warning (informing the operator that brain tissue or blood vessels exist in this direction and aspiration should be avoided), and aspiration control signals (which can be used to automatically control the negative pressure source). It may also include graded warning signals, hematoma clearance completion signals, etc.

[0051] In practice, the operator inserts the catheter body into the intracranial hematoma cavity along a predetermined minimally invasive path. After catheter insertion, the ultrasound detection unit and pose sensing unit are activated. The operator manipulates the catheter through axial rotation and axial advance / retreat, and the system collects ultrasound detection information and pose change information at different sampling times. Based on the ultrasound detection information and corresponding pose change information at each sampling time, the data coupling processing unit constructs a local boundary model of the residual hematoma and determines the relative position of the catheter body within the local boundary model. The output unit outputs aspiration decision information based on the local boundary model and relative position of the residual hematoma. The operator then performs safe aspiration operations based on the aspiration decision information.

[0052] Throughout the aspiration process, the system continuously performs the aforementioned sampling, modeling, and decision output, achieving a real-time closed loop of "perception-cognition-decision." As aspiration progresses, the hematoma volume gradually decreases, the local boundary model of the residual hematoma is dynamically updated, and the relative position of the catheter also changes accordingly. The output unit can output the updated aspiration decision information in real time until the hematoma is completely removed.

[0053] Based on the above embodiments, by integrating an ultrasound detection unit in the distal working area of ​​the catheter body and a pose sensing unit in the distal working area of ​​the catheter body, a local boundary model of the residual hematoma is constructed using pose-ultrasound coupling to determine the relative position of the catheter, and finally outputs directional aspiration decision information. This achieves a leap from single-point detection to spatial cognition, which can transform hematoma aspiration from blind operation relying on experience to precise guidance under spatial perception, thereby improving aspiration safety and hematoma clearance efficiency.

[0054] See Figure 2As shown, the distal working area of ​​the catheter body 1 can be equipped with an ultrasound detection unit 2 and a suction port 5. The suction port 5 can be arranged parallel to and in the same direction as the ultrasound detection unit 2. The distal working area or proximal interface section (proximal operating part) of the catheter body 1 can be equipped with a pose sensing unit 3. The pose sensing unit 3 can also be connected to a data coupling processing unit via a connecting line 4. The data coupling processing unit can also be connected to an output unit. The operator can rotate the distal working area of ​​the catheter body 1, causing the catheter body 1 to rotate around its own axis, thereby allowing the ultrasound detection unit 2 to perform boundary detection of the circumferential tissue of the hematoma cavity at different rotation angles.

[0055] In some embodiments, the catheter body is provided with a suction channel, and the distal working area of ​​the catheter body is provided with at least one suction port. The suction port is used to draw the contents of the hematoma cavity into the suction channel and discharge them out of the body under the action of suction negative pressure. The relative positional relationship between the suction port and the ultrasonic detection unit includes one of the following: A suction port is arranged parallel to and in the same direction as an ultrasonic detection unit; or A suction port is combined with multiple ultrasonic detection units, which are arranged in a circular pattern with equal angles.

[0056] Specifically, at least one aspiration channel can be provided within the catheter body, extending axially along the catheter body. At least one aspiration port can be provided at the distal end of the aspiration channel or the distal working area of ​​the catheter body. This aspiration port can be used to draw the contents of the hematoma cavity into the aspiration channel and drain it from the body under negative pressure. The proximal end of the aspiration channel can be connected to a negative pressure source, allowing for the aspiration and removal of the hematoma through the negative pressure provided by the source.

[0057] The number of aspiration ports can be one or more. When multiple aspiration ports are provided, they can be distributed circumferentially or axially along the catheter body. The specific form of the aspiration port can be a port located on the distal end face of the catheter body, a side hole located on the distal sidewall of the catheter body, or a combination of a port and a side hole. When a side hole is provided, it is preferably an elliptical or circular opening located on the distal sidewall of the catheter body. The ultrasonic detection unit is arranged in the distal working area of ​​the catheter body, especially in the area most relevant to the aspiration action, such as the distal end of the catheter and / or near the aspiration side hole, so that the detection area coincides with or is adjacent to the actual aspiration area.

[0058] The relative positional relationship between the suction port and the ultrasonic detection unit can specifically include one of the following: Layout Method 1: A suction port is arranged parallel to and in the same direction as an ultrasonic detection unit.

[0059] See Figure 3 As shown, in this layout, the distal working area of ​​the catheter body is equipped with a suction port 5 and an ultrasonic detection unit 2. The ultrasonic detection unit 2 can be fixed near the suction port 5, and the detection direction of the ultrasonic detection unit 2 is parallel to and faces the same direction as the suction direction of the suction port 5. Specifically, the ultrasonic detection unit 2 can be fixed on the proximal side of the suction port 5, and its sound beam emission direction points towards the suction direction of the suction port 5. In this layout, the detection area of ​​the ultrasonic detection unit 2 and the suction area of ​​the suction port 5 are spatially adjacent or overlapped, so that the ultrasonic detection information can directly reflect the tissue type about to enter the suction port 5, thereby achieving accurate "in-situ" sensing. This layout is simple in structure and low in manufacturing cost, but it can only detect one direction at a time, and requires rotating the catheter by a large angle (such as rotating 360°) to obtain complete circumferential boundary detection information.

[0060] Layout Method 2: A suction port is combined with multiple ultrasonic detection units, which are arranged in a circular pattern with equal angles.

[0061] See Figure 4 As shown, in this layout, the distal working area of ​​the catheter body is provided with a suction port 5 and multiple ultrasonic detection units 2 (preferably 2-6). The multiple ultrasonic detection units 2 are distributed at equal angular intervals around the circumference of the catheter body; for example, when four ultrasonic detection units 2 are provided, adjacent ultrasonic detection units 2 are spaced 90° apart. Each ultrasonic detection unit 2 is fixed near the suction port 5, and its detection direction points in different directions. Furthermore, the detection area of ​​each ultrasonic detection unit 2 is spatially adjacent to or overlaps with the suction area of ​​the suction port 5. With this layout, the system can simultaneously obtain boundary detection information in multiple directions, and a complete circumferential boundary detection result can be obtained by coordinating with small-angle rotation. For example, when four ultrasonic detection units 2 are arranged, only a 90° rotation of the catheter is needed to achieve 360° full-circumference detection, significantly improving detection efficiency.

[0062] Based on the above embodiments, by arranging the aspiration port and the ultrasound detection unit parallel and in the same direction, "in-situ" sensing before aspiration is achieved, allowing the ultrasound detection results to directly reflect the state of the tissue to be aspirated, thus reducing the risk of mis-aspiration. By arranging multiple ultrasound detection units in a circular pattern with equally spaced angles, multi-directional synchronous detection is achieved, improving boundary detection efficiency. This layout provides a structural basis for the accurate construction of local boundary models of residual hematoma.

[0063] In some embodiments, the construction of a local boundary model of the residual hematoma based on the ultrasound detection information and corresponding pose change information at each sampling time can, in specific implementation, include: Based on the ultrasound detection information, the distance of the hematoma boundary at each sampling time is determined; Spatial registration is performed between the hematoma boundary distance at each sampling time and the corresponding pose change information to obtain boundary sampling points with spatial coordinates; Boundary sampling points with spatial coordinates obtained at multiple different sampling times are spatially accumulated to form a boundary point cloud. The boundary point cloud is then fitted with a surface to construct a local boundary model of the residual hematoma.

[0064] In practice, the operator first inserts the catheter body into the intracranial hematoma cavity along a predetermined minimally invasive path, and then manipulates the catheter through axial rotation and axial advance and retreat. The system acquires ultrasound detection information and pose change information at each sampling moment. The data coupling processing unit receives the ultrasound detection information output by the ultrasound detection unit, and simultaneously receives the pose change information output by the pose sensing unit.

[0065] Secondly, the data coupling processing unit determines the hematoma boundary distance at the current sampling time based on the ultrasound detection information. Specifically, this can be achieved by performing bandpass filtering, envelope detection, and sliding time window analysis on the echo signal to detect characteristic echo gaps and calculate the hematoma boundary distance (detailed implementation is described in subsequent embodiments).

[0066] Then, the data coupling processing unit performs spatial registration of the hematoma boundary distance at the sampling moment with the corresponding pose change information. Specifically, the coordinate system corresponding to the initial pose of the catheter body can be used as the global reference system. A transformation matrix is ​​constructed based on the rotation angle information and the advance and retreat displacement information to map the boundary sampling points from the catheter coordinate system to the global reference system, thereby obtaining boundary sampling points with spatial coordinates (see the description of the following embodiments for detailed implementation details).

[0067] Next, the data coupling processing unit accumulates boundary sampling points with spatial coordinates obtained at multiple different sampling times to form a boundary point cloud. Each point in this boundary point cloud carries spatial coordinates and a tissue type label. The boundary point cloud is filtered to remove boundary sampling points with a confidence level lower than a preset confidence threshold, and the filtered point cloud is classified into hematoma boundary point cloud, brain tissue boundary point cloud, and junctional region point cloud according to the tissue type label. Finally, the data coupling processing unit performs surface fitting (such as moving least squares) on the hematoma boundary point cloud to obtain the local boundary surface of the residual hematoma, which serves as the local boundary model of the residual hematoma (detailed implementation details are described in subsequent embodiments).

[0068] Throughout the aspiration process, the data coupling processing unit continuously performs the above processing. As data from new sampling moments are continuously added, the boundary point cloud is continuously expanded, and the local boundary model of the residual hematoma can be dynamically updated.

[0069] Based on the above embodiments, by spatially registering and cumulatively fitting ultrasound detection information with pose change information, a local boundary model of residual hematoma is constructed, realizing the leap from single-point distance measurement to spatial model construction, which can provide spatial basis for determining the relative position of the catheter and output directional aspiration decision information.

[0070] In some embodiments, determining the hematoma boundary distance at each sampling moment based on the ultrasound detection information may, in specific implementation, include: The ultrasonic detection information is subjected to bandpass filtering and envelope detection to obtain the echo envelope signal; A sliding time window analysis is performed on the echo envelope signal. When at least one of the following features is detected: a decrease in echo envelope amplitude, an increase in the spacing between adjacent reflection peaks, or an interruption in echo continuity, it is determined that a characteristic echo gap appears at the target sampling time. The characteristic echo gap represents the ultrasound signal propagation path reaching the hematoma boundary. The distance to the hematoma boundary at the target sampling time is determined based on the flight time and the average sound velocity of brain tissue corresponding to the characteristic echo gap at the target sampling time.

[0071] Specifically, the implementation details for determining the hematoma boundary distance at each sampling time can be as follows: The ultrasound detection unit is fixed to the distal working area of ​​the catheter body and can periodically emit pulsed ultrasound waves. During the propagation of ultrasound waves within the hematoma, when the propagation path reaches the boundary of the hematoma region, due to the acoustic impedance difference between the hematoma and the surrounding brain tissue, some ultrasound energy is reflected, forming a characteristic echo gap in the echo signal. This characteristic echo gap can be characterized by: a decrease in echo envelope amplitude, an increase in the distance between adjacent reflection peaks, and an interruption in echo continuity.

[0072] The data coupling processing unit first performs bandpass filtering on the raw echo signal output by the ultrasonic detection unit. Bandpass filtering can be used to retain signal components within the effective frequency band that matches the ultrasonic transmission frequency, while filtering out noise interference outside the effective frequency band, thereby improving the signal-to-noise ratio.

[0073] Subsequently, the data coupling processing unit performs envelope detection on the filtered echo signal, extracting the echo signal's envelope, i.e., the curve showing the echo amplitude changing over time, thus obtaining the echo envelope signal. Envelope detection can be achieved through Hilbert transform or rectified filtering, among other methods. The echo envelope signal reflects the changing trend of the echo energy, providing a basis for subsequent boundary detection.

[0074] The data coupling processing unit can set a time window and gradually slide this time window along the time axis to analyze the energy changes of the echo envelope signal. When the detected echo energy is lower than a preset echo energy threshold and the duration exceeds the preset time window, the corresponding location is determined to be the hematoma boundary.

[0075] Simultaneously, at the location where the echo energy is detected to be below a set threshold and the duration exceeds a preset time window, the data coupling processing unit further detects the waveform characteristics of the echo envelope signal. If the echo envelope signal simultaneously exhibits at least one of the following characteristics: amplitude decrease (reduced transmitted energy), increased spacing between adjacent reflection peaks (extended reflection path), or interruption of echo continuity (new reflected waves generated at the boundary superimposed on the original echo), then a characteristic echo gap is determined to have occurred at the target sampling time. This characteristic echo gap can characterize that the ultrasound signal propagation path has reached the hematoma boundary.

[0076] Subsequently, the data coupling processing unit records the flight time t corresponding to the characteristic echo gap. b Flight time t b It can be defined as the round-trip time from the moment the ultrasound detection unit emits ultrasound waves to the moment it receives the characteristic echo generated by the reflection from the hematoma-brain tissue interface.

[0077] According to flight time t b Given the average speed of sound c in brain tissue, calculate the distance d from the hematoma boundary using the following formula: d=(c×t b ) / 2 Where c is the average speed of sound in brain tissue; t b The time of flight corresponds to the characteristic echo gap. The hematoma boundary distance d represents the radial distance from the ultrasound detection unit to the hematoma boundary.

[0078] It should be noted that each sampling time is sequentially used as the target sampling time to perform the above processing. The data coupling processing unit determines the hematoma boundary distance at each sampling time based on the ultrasound detection information at each sampling time.

[0079] Based on the above embodiments, the echo envelope signal is obtained by bandpass filtering and envelope detection of the echo signal, and the energy change of the echo envelope signal is analyzed by sliding time window. When a characteristic echo gap is detected, the distance of the hematoma boundary is calculated based on the flight time and the average sound speed of brain tissue. This realizes the automatic identification of the hematoma boundary and the automatic quantization of the distance, and improves the objectivity and real-time performance of the boundary identification.

[0080] In some embodiments, the above-mentioned spatial registration of the hematoma boundary distance at each sampling time with the corresponding pose change information to obtain boundary sampling points with spatial coordinates may include: A rotation matrix is ​​constructed based on the rotation angle information in the pose change information corresponding to the target sampling time, and a translation vector is constructed based on the forward and backward displacement information in the pose change information corresponding to the target sampling time. The transformation matrix of the target sampling time is composed of the rotation matrix and the translation vector. Obtain the fixed position of the ultrasound detection unit in the catheter coordinate system at the target sampling time, and the unit vector of the detection direction in the catheter coordinate system at the target sampling time; Based on the hematoma boundary distance at the target sampling time, the fixed position of the ultrasound detection unit in the catheter coordinate system, and the unit vector, calculate the position of the boundary sampling point in the catheter coordinate system at the target sampling time. By using the transformation matrix of the target sampling time, the position of the boundary sampling point at the target sampling time in the catheter coordinate system is mapped to the global reference system, forming the boundary sampling point with spatial coordinates at the target sampling time. The global reference system is the coordinate system corresponding to the initial pose of the catheter body.

[0081] Specifically, the above-mentioned spatial registration of the hematoma boundary distance with the corresponding pose change information at each sampling time to obtain the boundary sampling points with spatial coordinates can be implemented in the following details: The data coupling processing unit first obtains the hematoma boundary distance d at the target sampling time. i And the rotation angle information θ in the pose change information corresponding to the target sampling time. i and forward / backward displacement information p i .

[0082] Then, the data coupling processing unit uses the rotation angle information θ i Construct rotation matrix R i Wherein, the rotation matrix R i This describes the directional change of the catheter body from its initial posture to the target sampling time. Simultaneously, the data coupling processing unit processes the forward and backward displacement information p... i Construct translation vector t i By rotation matrix R i Translation vector t i Combined into transformation matrix T i This transformation matrix fully describes the spatial transformation relationship of the catheter body from its initial pose to its pose at the target sampling time.

[0083] It should be noted that the transformation matrix T here... i A dedicated transformation matrix can be registered for boundary points at a single sampling time. Its application is to a single hematoma boundary sampling point. The core purpose is to map the boundary point measured at that time from the local coordinate system of the catheter to the global reference coordinate system, which serves the accumulation of boundary point cloud and surface modeling.

[0084] Next, the data coupling processing unit obtains the fixed position P of the ultrasonic detection unit in the catheter coordinate system. probe This fixed position can be determined by the fixed installation position of the ultrasonic detection unit on the catheter, and is a known fixed parameter. Simultaneously, the data coupling processing unit obtains the unit vector v of the detection direction in the catheter coordinate system. local ( i The unit vector is determined by the fixed installation orientation of the ultrasonic detection unit, which is also a known fixed parameter. i This indicates the azimuth angle of the detection direction relative to the catheter coordinate system. The catheter coordinate system can be a local coordinate system with the catheter body as a reference. Its origin is set at the center of the distal end face of the catheter body, the X-axis points to the proximal end along the axis of the catheter body, and the Y and Z axes are located within the cross-section of the catheter body. When the catheter body rotates or moves forward or backward, the catheter coordinate system moves accordingly, but the fixed position of the ultrasound detection unit in the catheter coordinate system remains unchanged.

[0085] Next, the data coupling processing unit calculates the distance d from the hematoma boundary. i The fixed position P of the ultrasonic detection unit in the catheter coordinate system probe and unit vector v local ( i ), calculate the position P of the boundary sampling point in the duct coordinate system at the target sampling time. local_i The calculation formula can be: P local_i =P probe +d i ×v local ( i ).

[0086] Finally, the data coupling processing unit transforms the matrix T. i The position P of the boundary sampling point in the duct coordinate system local_i Mapping to the global reference frame, we obtain the position (i.e., three-dimensional spatial coordinates) P of the boundary point at the target sampling time in the global reference frame. global_i Then, based on the position P of the boundary point in the global reference frame at the target sampling time... global_i Tissue type label L corresponding to the target sampling time i and confidence level c i By performing correlation, boundary sampling points with spatial coordinates at the target sampling time are formed. i Among them, the organization type label L i It can be used to identify the tissue category to which the boundary sampling point belongs, with a confidence level of c. iThis can be used to measure the reliability of the boundary sampling point in subsequent filtering processes. The calculation formula for the mapping process can be: P global_i =T i ×P local_i The global reference frame is the coordinate system corresponding to the initial pose of the catheter body.

[0087] It should be noted that each sampling moment is used as the target sampling moment to perform the above processing. The data coupling processing unit performs spatial registration of the hematoma boundary distance at each sampling moment with the corresponding pose change information to obtain the boundary sampling point with spatial coordinates corresponding to each sampling moment.

[0088] Based on the above embodiments, by constructing a transformation matrix according to the pose change information, the hematoma boundary distance at each sampling time is spatially registered with the corresponding pose change information, and the one-dimensional distance information is transformed into boundary sampling points with spatial coordinates. This achieves spatial alignment of data at different sampling times and provides a spatial data foundation for the subsequent construction of a local boundary model of the residual hematoma.

[0089] In some embodiments, the above-described surface fitting of the boundary point cloud to construct a local boundary model of the residual hematoma may, in specific implementation, include: The boundary point cloud is filtered to remove boundary point clouds with confidence scores lower than a preset confidence threshold. The filtered boundary point clouds are classified into hematoma boundary point clouds, brain tissue boundary point clouds, and junctional area point clouds according to the tissue type label. The point cloud of the hematoma boundary is fitted with a surface to obtain the local boundary surface of the residual hematoma, which serves as the local boundary model of the residual hematoma.

[0090] Specifically, the implementation details of the above-mentioned surface fitting of the boundary point cloud to construct the local boundary model of the residual hematoma can be as follows: The data coupling processing unit first filters the accumulated boundary point cloud. This cloud may contain some boundary sampling points with low reliability, which can affect the accuracy of subsequent surface fitting. The unit filters each boundary sampling point based on its confidence level, removing those with a confidence level below a preset threshold (e.g., 0.7). Confidence level is a reliability index calculated based on factors such as signal quality and echo feature matching, and can be used to measure the reliability of each boundary sampling point. Filtering removes unreliable sampling points, improving the accuracy of subsequent residual hematoma local boundary model construction.

[0091] Then, the data coupling processing unit classifies the filtered boundary point clouds into hematoma boundary point clouds, brain tissue boundary point clouds, and junctional area point clouds according to tissue type labels. Specifically, each boundary sampling point has been identified and labeled with a tissue type label (which may include hematoma, brain tissue, junctional area, etc.) by the ultrasound detection unit in the above steps. The data coupling processing unit divides the point cloud into three categories according to the tissue type label: hematoma boundary point cloud (boundary points labeled "hematoma", which can be used to construct hematoma boundary surfaces), brain tissue boundary point cloud (boundary points labeled "brain tissue", which can be used to determine the direction of danger later), and junctional area point cloud (boundary points labeled "junctional area", which can be used as an auxiliary reference).

[0092] Finally, the data coupling processing unit performs surface fitting on the hematoma boundary point cloud to obtain the local boundary surface of the residual hematoma, which serves as the local boundary model of the residual hematoma. Surface fitting can be performed using one of the following methods: least squares, radial basis function interpolation, moving least squares, or Delaunay triangulation.

[0093] Preferably, the moving least squares method can be used for surface fitting, and its specific steps may include: First, determining the fitting region. The bounding box of the hematoma boundary point cloud is used as the range of surface fitting. This bounding box defines the spatial boundary of the fitted surface, ensuring that subsequent fitting operations are performed within the effective spatial region. Second, establishing a local fitting function. Multiple local neighborhoods are divided within the fitting region, and a quadratic polynomial is used as the local fitting function in each local neighborhood. The purpose of using a quadratic polynomial is that it can better balance fitting accuracy and computational complexity, accurately representing the local morphological changes of the hematoma boundary without introducing excessive computational overhead. Third, determining the weighting function. A Gaussian kernel function is used as the weighting function, with the weight decreasing exponentially with distance. The purpose is to ensure that sampling points closer to the current fitting point have a higher contribution weight to the fitting result, while sampling points farther away have a smaller contribution, thus ensuring that the fitting of each local region is mainly determined by the sampling points near that region, avoiding interference from distant points on the local fitting. Fourth, solving for the fitting coefficients. Within each local neighborhood, the fitting coefficients that minimize the sum of squared weighted errors are obtained using the weighted least squares method. The sum of squared weighted errors is calculated by multiplying the fitting error at each sampling point by its corresponding weight, squared, and then summed. The obtained fitting coefficients determine the specific shape of the fitted surface within that local neighborhood. The fifth step is to fuse the output surface. The fitting results from all local neighborhoods are fused, and the surfaces between adjacent neighborhoods are smoothed using a weighted average, ultimately resulting in a continuous local boundary surface of the residual hematoma.

[0094] Based on the above embodiments, by performing surface fitting on the hematoma boundary point cloud to construct the local boundary surface of the residual hematoma, the transformation from discrete point cloud to continuous spatial model is realized, providing a spatial model basis for determining the relative position of the catheter and output directional aspiration decision information.

[0095] In some embodiments, determining the relative position of the catheter body within the local boundary model of the residual hematoma may, in specific implementation, include: Obtain the transformation matrix corresponding to the current pose of the catheter body; Obtain the fixed position of the distal working area of ​​the catheter body in the catheter coordinate system. Through the transformation matrix corresponding to the current pose, map the fixed position of the distal working area of ​​the catheter body in the catheter coordinate system to the global reference system to obtain the position of the distal working area of ​​the catheter body in the global reference system. Calculate the distance from the position of the distal working area of ​​the catheter body in the global reference frame to the target distance of the local boundary model of the residual hematoma; Based on the comparison between the target distance and the preset distance threshold, the region where the catheter body is located in the local boundary model of the residual hematoma is determined.

[0096] Specifically, the implementation details for determining the relative position of the catheter body within the local boundary model of the residual hematoma are as follows: The data coupling processing unit first obtains the transformation matrix T corresponding to the current pose of the catheter body. current Specifically, the current rotation angle information θ is read from the pose sensing unit. current and current forward / backward displacement information p current Construct the transformation matrix T for the current sampling time using the same method as described above. current The transformation matrix describes the spatial transformation relationship of the duct body from its initial pose to its current pose.

[0097] It should be noted that the transformation matrix T here... current A dedicated current transformation matrix can be used to solve the catheter body pose. Its target is the distal working area of ​​the catheter body. The core purpose is to solve the real-time position of the catheter itself in the global reference coordinate system, which serves to determine the risk area of ​​the catheter relative to the hematoma boundary.

[0098] Then, the data coupling processing unit obtains the fixed position P of the distal working area of ​​the catheter body in the catheter coordinate system. workzone The distal working area is the region at the distal end of the catheter body used for aspiration and boundary detection. workzoneThis refers to the fixed position of this region in the catheter coordinate system (e.g., the center point of the distal working area or the center point of the distal end face). This fixed position is a known fixed parameter determined by the geometry of the catheter body and the location of the distal working area.

[0099] The data coupling processing unit uses the transformation matrix T corresponding to the current pose. current The fixed position P of the distal working area of ​​the catheter body in the catheter coordinate system. workzone Mapping to the global reference frame, we obtain the position P of the distal working area of ​​the catheter body in the global reference frame. workzone_global The calculation formula can be: P workzone_global =T current ×P workzone .

[0100] It should be noted that the distal working area, which is the area where the ultrasound detection unit and aspiration port are located, directly determines the spatial position of the ultrasound detection and aspiration action. Therefore, the position of this area can be used as the representative position of the catheter body in the global reference system, and can be used to determine the relative position of the catheter and the hematoma boundary in the subsequent process.

[0101] Next, the data coupling processing unit calculates the position P of the distal working area of ​​the catheter body in the global reference frame. workzone_global The target distance to the local boundary model of the residual hematoma. This target distance (shortest distance) d min For P workzone_global The minimum distance among all points on the local boundary surface of the residual hematoma. The calculation method can be: traverse all triangular faces on the local boundary surface of the residual hematoma and calculate P. workzone_global The minimum value among the target distances to each triangular facet is taken as the target distance d. min . d min This reflects how far the distal working area of ​​the catheter body is from the hematoma boundary: d min The larger the diameter, the deeper the catheter's working area extends into the hematoma; d min The smaller the value, the closer the catheter working area is to the hematoma boundary; d min A value of ≈0 indicates that the catheter working area has reached the hematoma boundary. It should be noted that the target distance here can be the shortest spatial distance without directional limitations, and is a global scalar indicator characterizing the degree of proximity between the entire catheter and the hematoma boundary.

[0102] Finally, the data coupling processing unit determines the target distance d based on the target distance d. min The comparison result with the preset distance threshold determines the region where the catheter body is located in the local boundary model of the residual hematoma, which is used as the relative position.

[0103] Based on the above embodiments, by mapping the fixed position of the distal working area of ​​the catheter body in the catheter coordinate system to the global reference system, the position of the distal working area in the global reference system is obtained, and the target distance from this position to the local boundary model of the residual hematoma is calculated. This realizes the quantitative judgment of the relative position of the catheter in the hematoma boundary model, providing an objective basis for subsequent graded early warning and aspiration control.

[0104] In some embodiments, the aforementioned preset distance threshold may include a first preset distance threshold and a second preset distance threshold; correspondingly, determining the region where the catheter body is located in the local boundary model of the residual hematoma based on the comparison result between the target distance and the preset distance threshold may, in specific implementation, include: When the target distance is greater than a first preset distance threshold, it is determined that the catheter body is located in the hematoma center area; When the second preset distance threshold is less than the target distance and the target distance is less than or equal to the first preset distance threshold, it is determined that the catheter body is in the hematoma edge area; When the target distance is less than or equal to the second preset distance threshold, the catheter body is determined to be in a high-risk contact zone; wherein the first preset distance threshold is greater than the second preset distance threshold.

[0105] Specifically, the implementation details for determining the region where the catheter body is located based on the comparison result between the target distance and the preset distance threshold are as follows: The data coupling processing unit has a preset first preset distance threshold D. center Second preset distance threshold D edge D center >D edge D center It can be used to determine whether the catheter is located in the center of the hematoma, D edge It can be used to determine whether the catheter has approached or reached the safe limit of the hematoma boundary.

[0106] The data coupling processing unit can calculate the target distance d min The comparison with the two preset distance thresholds mentioned above can be performed using the following logic: When d min >D center At this point, the catheter body is positioned in the central area of ​​the hematoma. The distal end of the catheter body is relatively far from the hematoma boundary, and there is sufficient surrounding hematoma tissue, allowing for safe aspiration.

[0107] When D edge <d min ≤D centerAt this point, the catheter body is determined to be in the hematoma periphery. The distal end of the catheter body is now close to the hematoma boundary, requiring careful handling, reducing the suction negative pressure, and preventing aspiration of brain tissue.

[0108] When d min ≤D edge If the catheter body is found to be in a high-risk contact area, and the distal end of the catheter body is very close to or has already contacted the hematoma boundary, aspiration should be stopped immediately to avoid damaging brain tissue.

[0109] Based on the above embodiments, by comparing the target distance with the first preset distance threshold and the second preset distance threshold, the area where the catheter is located is quantified into the hematoma center area, the hematoma edge area and the high-risk contact area, thus realizing the objective judgment of the relative position of the catheter and providing a quantitative basis for subsequent graded early warning and aspiration control.

[0110] In some embodiments, the output unit is used to output aspiration decision information based on the residual hematoma local boundary model and the relative position. In specific implementations, this may include: The safety aspiration level is determined based on the region where the catheter body is located in the local boundary model of the residual hematoma. Centered on the position of the distal working area of ​​the catheter body in the global reference frame, multiple directions are traversed in the vertical plane of the catheter body axis. For each direction angle, the boundary distance from the position of the distal working area of ​​the catheter body in the global reference frame along the target direction to the local boundary model of the residual hematoma is calculated. Based on the safety suction level and the boundary distance, suction decision information is output.

[0111] Specifically, the implementation details of the above-mentioned output unit outputting aspiration decision information based on the local boundary model and relative position of the residual hematoma can be as follows: The output unit first acquires the region (hematoma center, hematoma edge, or high-risk contact area) where the catheter body is located in the residual hematoma local boundary model, as determined by the data coupling processing unit, and then determines the safety aspiration level based on this region. Specifically, when the catheter body is located in the hematoma center, the safety aspiration level is determined to be high; when the catheter body is located in the hematoma edge, the safety aspiration level is determined to be medium; and when the catheter body is located in the high-risk contact area, the safety aspiration level is determined to be low.

[0112] Simultaneously, the output unit acquires the local boundary surface of the residual hematoma constructed by the data coupling processing unit, as well as the position P of the distal working area of ​​the catheter body in the global reference frame. workzone_global The position P of the distal working area of ​​the catheter body in the global reference frame. workzone_global Centered on point P, within the plane perpendicular to the axial direction of the catheter body (i.e., passing through P) workzone_globalAnd in a plane perpendicular to the axis of the catheter body, traverse all directions from 0° to 360° with a preset step size. For each direction angle θ, from P workzone_global A ray is emitted along the direction vector v(θ) (in the global reference frame). The intersection point of this ray with the local boundary surface of the residual hematoma is calculated, and the position P of the distal working area of ​​the catheter body in the global reference frame is calculated. workzone_global The boundary distance r(θ). If the ray does not intersect the boundary surface, then r(θ) takes a larger default value, indicating that no boundary was detected in this direction, that is, there is no hematoma boundary constraint in this direction.

[0113] The physical meaning of the boundary distance r(θ) can be: the radial distance from the distal working area of ​​the catheter to the hematoma boundary along this direction. The larger r(θ) is along this direction, the thicker the hematoma is, the more hematoma can be aspirated, and the farther the boundary is from the brain tissue boundary, the higher the safety of aspiration; the smaller r(θ) is along this direction, the closer it is to the hematoma boundary, and the higher the risk.

[0114] The output unit can comprehensively output suction decision information based on the safety suction level and the boundary distance r(θ) in each direction.

[0115] Based on the above embodiments, by determining the safety aspiration level according to the area where the catheter is located, and calculating the boundary distance from each direction to the hematoma boundary surface with the distal working area of ​​the catheter as the center, the aspiration decision information is comprehensively output by combining the safety aspiration level and boundary distance information, thus realizing the organic combination of graded early warning and directional decision-making, which can provide operators with more accurate and targeted operation guidance.

[0116] In some embodiments, the above-mentioned output of suction decision information based on the safety suction level and the boundary distance may, in specific implementation, include: When the safety suction level is high, the target direction with a boundary distance greater than or equal to a preset safety distance threshold is determined as the recommended suction direction, and the target direction with a boundary distance less than the preset safety distance threshold is determined as the dangerous direction, and a first-level dangerous direction warning is output. When the safety aspiration level is medium, an alert is output for approaching the hematoma boundary, and the target direction where the boundary distance is less than the preset safety distance threshold is determined as the danger direction, and a level two danger direction alert is output. When the safety aspiration level is low, an emergency warning is issued for approaching brain tissue, and a control signal to stop aspiration is also issued.

[0117] Specifically, when the safety aspiration level is high, the catheter body is located in the central area of ​​the hematoma. At this time, the distal working area of ​​the catheter body is far from the hematoma boundary, and there is sufficient hematoma tissue around it, allowing for safe aspiration. The output unit identifies all target directions with a boundary distance r(θ) greater than or equal to a preset safety distance threshold as recommended aspiration directions. If multiple recommended directions exist, the direction with the largest r(θ) is selected as the optimal recommended direction, marked with a green arrow on the display screen, accompanied by a voice prompt "It is recommended to aspirate in the direction of XX degrees." Simultaneously, the output unit identifies all target directions with r(θ) less than the preset safety distance threshold as dangerous directions, marked with a yellow area, and outputs a Level 1 dangerous direction warning. The Level 1 dangerous direction warning can be used to inform the operator that the hematoma in that direction is thinner and less safe than other directions, suggesting prioritizing aspiration in the recommended direction. The warning method can be a yellow indicator light and / or a voice prompt "The hematoma in the XX direction is thinner; it is recommended to adjust the direction."

[0118] When the safety aspiration level is medium, the catheter body is located in the hematoma edge area. At this time, the distal working area of ​​the catheter body is close to the hematoma boundary, requiring careful operation and reduction of aspiration negative pressure. The output unit first outputs a warning of approaching the hematoma boundary, which can be indicated by a yellow indicator light and / or a voice prompt, "Approaching the hematoma boundary, please operate with caution." Simultaneously, the output unit identifies all target directions where r(θ) is less than the preset safe distance threshold as dangerous directions, marking them with orange areas and outputting a secondary dangerous direction warning. The secondary dangerous direction warning can be used to remind the operator that the direction is approaching or has reached the hematoma boundary, and forcibly aspirating in this direction may result in the aspiration of brain tissue; aspiration in this direction should be avoided. The warning method can be an orange indicator light and / or a voice prompt, "Direction XX is approaching the boundary, do not aspirate in this direction." At this time, the output unit does not output a recommended aspiration direction (i.e., it does not provide a "suggest aspiration in direction XX" prompt), because the entire catheter is in the edge area, and the safe operating space is limited; warnings and careful operation should be the primary focus.

[0119] When the safety aspiration level is low, the catheter body is in a high-risk contact area. At this time, the distal working area of ​​the catheter body is very close to or has already contacted the brain tissue boundary, and aspiration should be stopped immediately. The output unit outputs an emergency warning indicating proximity to brain tissue, which may be indicated by a red indicator light and / or an emergency voice prompt: "Approaching brain tissue, stop aspiration immediately." Simultaneously, the output unit does not output any recommended aspiration direction and outputs a stop aspiration control signal to the aspiration control unit, which then controls the negative pressure source to stop aspiration.

[0120] Based on the above embodiments, by performing graded decisions according to the safety aspiration level, a recommended aspiration direction and a first-level danger direction warning are output at high levels; a warning of approaching the hematoma boundary and a second-level danger direction warning are output at medium levels; and an emergency warning of approaching brain tissue and a stop aspiration signal are output at low levels. The warning methods and urgency levels of the first-level danger direction warning and the second-level danger direction warning are different, realizing the organic combination of graded warning and directional decision-making, which can provide operators with more accurate and targeted operation guidance.

[0121] In some embodiments, see Figure 5 As shown, the above system may further include a suction control unit and a negative pressure source. The suction control unit is connected to the output unit and the negative pressure source respectively, and is used to receive the suction control signal output by the output unit, and control the negative pressure source according to the suction control signal to adjust the suction negative pressure at the suction port.

[0122] Specifically, the suction control unit can be connected to both the output unit and the negative pressure source. The suction decision information output by the output unit may include a suction control signal. The suction control unit receives this suction control signal and controls the operating state of the negative pressure source according to the suction control signal to adjust the suction negative pressure at the suction port.

[0123] The negative pressure source can be a negative pressure suction device, a suction pump, or other device capable of providing negative pressure. The negative pressure source is connected to the suction channel near the proximal end of the catheter body via tubing, providing suction negative pressure to the suction port. Control signals can be transmitted between the suction control unit and the negative pressure source via electrical or communication connections.

[0124] The suction control signal can include negative pressure adjustment commands (such as increasing negative pressure, decreasing negative pressure, or maintaining the current negative pressure) and suction start / stop commands (such as starting suction, pausing suction, or stopping suction). Based on the received suction control signal, the suction control unit sends corresponding control commands to the negative pressure source, which then adjusts the output negative pressure or its start / stop status according to the commands. For example, the suction control unit can control the valve opening of the negative pressure source or the pump speed, thereby achieving precise adjustment of the suction negative pressure.

[0125] Based on the above embodiments, by setting up a suction control unit and a negative pressure source, the system can automatically execute the corresponding negative pressure adjustment action after outputting suction decision information, forming a complete closed-loop control link from "perception → cognition → decision → execution".

[0126] In some embodiments, the suction control unit described above is configured to perform one or more of the following control actions according to the suction control signal: When the catheter body is in the center of the hematoma and the current aspiration direction is consistent with the recommended aspiration direction, the negative pressure source is controlled to maintain or increase the aspiration negative pressure. When the catheter body is in the hematoma edge area or the current aspiration direction is judged to be a dangerous direction, the negative pressure source is controlled to gradually reduce the aspiration negative pressure to a preset safe negative pressure threshold. When the output approaches the brain tissue emergency warning, the negative pressure source is controlled to suspend suction. When the signal indicating that the hematoma has been cleared is output, the negative pressure source is controlled to stop suction.

[0127] Specifically, the suction control unit can execute corresponding control actions based on the received suction control signal and the current area and suction direction of the catheter body.

[0128] When the catheter body is in the center of the hematoma and the current aspiration direction is consistent with the recommended aspiration direction, the aspiration control unit controls the negative pressure source to maintain or increase the aspiration negative pressure in order to maintain a high efficiency in hematoma clearance.

[0129] When the catheter body is located at the edge of a hematoma or the current aspiration direction is deemed dangerous, the aspiration control unit gradually reduces the aspiration negative pressure to a preset safe negative pressure threshold to avoid sudden pressure changes that could impact the tissue. By reducing the negative pressure, low-pressure drainage can be maintained in areas near the boundary instead of active aspiration, thereby reducing the risk of aspirating brain tissue.

[0130] When the output approaches the brain tissue emergency warning level, the suction control unit immediately controls the negative pressure source to pause suction. Specifically, the suction control unit closes the valve of the negative pressure source or stops the operation of the negative pressure pump, while keeping the suction channel unobstructed (drainage is allowed but no active suction), and resumes suction after operator confirmation.

[0131] When the output signal indicates that hematoma removal is complete, the suction control unit stops the suction by controlling the negative pressure source. Specifically, the suction control unit completely shuts off the negative pressure source and closes the suction channel valve, ending the suction operation.

[0132] Based on the above embodiments, the aspiration control unit automatically performs graded negative pressure control according to the area where the catheter is located and the direction of aspiration. It maintains efficient aspiration in the safe area, reduces negative pressure in the edge area, and pauses or stops aspiration in the danger area. This realizes intelligent automatic adjustment of aspiration negative pressure, further reducing the risk of aspiration of brain tissue and improving aspiration safety.

[0133] In some embodiments, the suction control unit may also perform the following control actions: Limiting the continuous aspiration time in a certain direction: When the boundary distance of the catheter body in a certain direction is less than a preset safe distance threshold but still within the safe range, the aspiration control unit allows aspiration in that direction, but sets a maximum continuous aspiration time. Aspiration will automatically pause after the time is exceeded, prompting the operator to adjust the catheter direction to prevent excessive aspiration in the same direction from causing accidental injury.

[0134] Adjusting the intermittent aspiration rhythm: When a coagulated hematoma is identified based on echo characteristics, the aspiration control unit switches from continuous aspiration mode to pulsed aspiration mode. Specifically, the aspiration control unit controls the negative pressure source to alternately turn on and off at a preset pulse frequency and duty cycle. The pulse frequency can be dynamically adjusted according to the hematoma stiffness; when the hematoma stiffness is high, the pulse frequency is increased to enhance the fragmentation effect, and when the hematoma stiffness is low, the pulse frequency is decreased to reduce tissue disturbance.

[0135] Suction is only permitted when the area is deemed safe: The suction control unit monitors the boundary distance corresponding to the current suction direction in real time. If the boundary distance in this direction is greater than the preset safe distance threshold, suction is permitted; if the boundary distance in this direction is less than the preset safe distance threshold, suction in this direction is automatically paused, and the operator is prompted that "the current direction is not safe, please rotate the conduit to a safe direction".

[0136] Through the above control actions, the system forms a closed-loop safe aspiration system of "pose sampling - boundary reconstruction - risk assessment - aspiration control", realizing intelligent automatic adjustment of aspiration negative pressure, further reducing the risk of accidental aspiration of brain tissue and improving aspiration safety.

[0137] In some embodiments, see Figure 5 As shown, the above system may also include an auxiliary sensing unit, and the data coupling processing unit may also be used to fuse the auxiliary information collected by the auxiliary sensing unit with the ultrasonic detection information and pose change information to correct the spatial coordinates of the boundary sampling points.

[0138] Specifically, the system may further include one or more auxiliary sensing units, which may be selected from pressure sensors, impedance sensors, flow sensors, or vibration sensors. The auxiliary sensing units may be located in the distal working area or aspiration channel of the catheter body to collect auxiliary information. This auxiliary information may include pressure information (such as the pressure value at the aspiration port), impedance information (such as the electrical impedance characteristics of tissue), flow information (such as the fluid flow rate within the aspiration channel), and / or vibration information (such as the vibration characteristics of the catheter).

[0139] The data coupling processing unit can receive auxiliary information collected by the auxiliary sensing unit and fuse the auxiliary information with ultrasonic detection information and pose change information to correct the spatial coordinates of the boundary sampling points.

[0140] For example, if the data coupling processing unit identifies "brain tissue" based on ultrasound detection information, but the pressure value displayed by the pressure sensor does not exceed the tissue contact pressure threshold, it indicates that the catheter body may not actually be in contact with the brain tissue, and the ultrasound signal may be misjudged due to blood clots within the hematoma or signal noise. In this case, the data coupling processing unit corrects the tissue type label to "boundary zone" or "hematoma," thereby improving the accuracy of boundary identification.

[0141] For example, when the flow sensor detects a sudden increase in flow rate in the suction channel, combined with the boundary distance r( of the current suction direction) and ultrasound detection information, it can be determined whether the blood vessel area has been suctioned or the hematoma has been basically cleared, thereby helping to verify the accuracy of the hematoma clearance signal.

[0142] For example, when the pressure signal exhibits periodic fluctuations synchronized with the cardiac cycle, it is identified as a nearby vascular region, automatically triggering the vascular protection mode and correcting the label of the boundary sampling point in that direction to "vascular".

[0143] The specific fusion methods for auxiliary information with ultrasonic detection information and pose change information can be data-level fusion, feature-level fusion, or decision-level fusion. Preferably, decision-level fusion is adopted, that is, after processing each type of sensor information independently, the processing results are comprehensively judged to improve the robustness and accuracy of the system.

[0144] Based on the above embodiments, by introducing an auxiliary sensing unit to collect auxiliary information such as pressure, impedance, flow rate, and vibration, and fusing the auxiliary information with ultrasonic detection information and pose change information, the spatial coordinates and tissue type labels of the boundary sampling points are corrected, thereby improving the accuracy and robustness of the boundary model construction and reducing the risk of misjudgment by a single sensor.

[0145] In some embodiments, see Figure 5 As shown, the system may further include a display / prompt unit, which is connected to the output unit and can be used to output spatial perception results and suction decision suggestions to the operator.

[0146] Specifically, the display / prompt unit can be connected to the output unit, receive the suction decision information generated by the output unit, and present it to the operator in one or more prompt formats. Prompt formats may include, but are not limited to: On-screen graphical display: A 3D schematic diagram of the local boundary model of the residual hematoma is drawn on the display screen, marking the current position of the catheter body, the recommended aspiration direction (e.g., green arrow), the danger direction (e.g., red area), and the approximate shape of the residual hematoma area. The operator can intuitively understand the spatial distribution of the residual hematoma and the positional relationship of the catheter within it through the screen.

[0147] Audio prompts: Suction decision information is announced via voice, such as "Suctioning at a 45° angle is recommended," "Approaching the hematoma boundary, please proceed with caution," and "Approaching brain tissue, stop suction immediately." Audio prompts allow the operator to receive crucial information while focusing on the surgical procedure, without needing to shift their gaze.

[0148] Indicator lights indicate different risk levels. For example, a green indicator light indicates safety (normal suction is possible), a yellow indicator light indicates warning (approaching the boundary, caution is required), an orange indicator light indicates danger (approaching the boundary, adjustments should be made immediately), and a red indicator light indicates emergency (stop suction immediately).

[0149] Vibration alerts: These alerts convey warning information to the operator through vibrations of different frequencies or intensities. For example, slight vibrations indicate caution, while strong vibrations indicate an emergency warning.

[0150] Tiered risk warnings: Different levels of risk warnings are output based on the safety of the area and direction of the catheter. Level 1 warning (e.g., yellow indicator light) indicates that the hematoma is thin and it is recommended to adjust the direction; Level 2 warning (e.g., orange indicator light) indicates that the catheter is close to the hematoma boundary and caution should be exercised; Level 3 warning (e.g., red indicator light + audible alarm) indicates that the catheter is close to brain tissue and aspiration should be stopped immediately.

[0151] The prompts output by the display / prompt unit may include at least one of the following: the current position of the catheter relative to the hematoma (e.g., "Catheter is in the center of the hematoma", "Catheter is in the edge of the hematoma", "Catheter is in a high-risk contact area"); the recommended direction to continue aspiration (e.g., "It is recommended to aspirate at 45°"); the direction not recommended to continue aspiration (e.g., "The 180° direction is close to the brain tissue, do not aspirate in this direction"); warning prompts indicating proximity to the brain tissue (e.g., "Approaching the boundary of the hematoma, please reduce the negative pressure" "Approaching the brain tissue, stop aspiration immediately"); prompts suggesting retraction, rotation, or stopping aspiration (e.g., "It is recommended to retract 2mm" or "It is recommended to rotate the catheter to the left").

[0152] Based on the above embodiments, through various prompts and rich prompt content, operators can intuitively and quickly obtain aspiration decision information, reducing the difficulty of surgical operation and cognitive burden, enabling operators to take appropriate operational measures in a timely manner, and further improving the safety of aspiration.

[0153] The complete working principle of the spatial sensing and safe aspiration catheter system for residual hematoma in cerebral hemorrhage provided in the embodiments of this manual can be summarized as follows: After the operator places the catheter body into the intracranial hematoma cavity, they manipulate the catheter through axial rotation and axial advance / retreat. The ultrasound detection unit emits ultrasound waves to the surrounding tissue and receives echo signals at each sampling moment, outputting ultrasound detection information. Simultaneously, the pose sensing unit acquires corresponding pose change information. The data coupling processing unit first calculates the hematoma boundary distance based on the characteristic echo gaps in the echo signals, then spatially registers the hematoma boundary distance at each sampling moment with the corresponding pose change information to obtain boundary sampling points with spatial coordinates. Next, the boundary sampling points from multiple sampling moments are accumulated to form a boundary point cloud, and a local boundary model of the residual hematoma is constructed through surface fitting. Based on this, the data coupling processing unit calculates the target distance from the distal working area of ​​the catheter to the boundary model according to the current catheter pose, compares it with a preset distance threshold to determine the region where the catheter is located (hematoma center / edge / high-risk contact area). The output unit determines the safety aspiration level based on the region where the catheter is located, and calculates the boundary distances along the target direction to the local boundary model of the residual hematoma in each direction, centered on the distal working area of ​​the catheter, and comprehensively outputs recommended aspiration directions, graded danger direction warnings, and / or aspiration control signals. The suction control unit automatically adjusts the negative pressure based on control signals to achieve closed-loop safe suction. The display / prompt unit can present suction decision information to the operator in various forms to guide safe suction.

[0154] In some embodiments, the system described above can be simplified to include only a catheter body, an ultrasound detection unit, a data coupling processing unit, and an output unit. In this simplified embodiment, the distal working area of ​​the catheter body is placed within the hematoma cavity. The ultrasound detection unit is located in the distal working area of ​​the catheter body and is used to emit ultrasound signals to the tissue surrounding the distal working area of ​​the catheter body and receive echo signals to acquire ultrasound detection information. The data coupling processing unit is connected to the ultrasound detection unit and is used to determine the hematoma boundary distance based on the ultrasound detection information. It compares the hematoma boundary distance with a preset safe distance threshold. When the hematoma boundary distance is greater than or equal to the preset safe distance threshold, it outputs a signal allowing aspiration. When the hematoma boundary distance is less than the preset safe distance threshold, it outputs a stop aspiration signal and / or a danger direction warning signal. The output unit is connected to the data coupling processing unit and is used to output the aforementioned aspiration decision information. In this simplified embodiment, the determination of the aspiration direction is made by the operator based on clinical experience, which eliminates the need for a pose sensing unit and related spatial registration and model building steps, making the system structure simpler and less costly, and suitable for clinical scenarios where high spatial positioning accuracy is not required.

[0155] In some embodiments, the above system can be applied not only to the aspiration and removal of hematoma cavities in cerebral hemorrhage, but also to other clinical scenarios requiring real-time boundary detection and safe aspiration, such as, but not limited to: hematoma aspiration in other intracranial locations, tumor ablation and aspiration resection (e.g., breast nodule ablation and resection), and ultrasonic fragmentation and aspiration resection. In these application scenarios, the distal working area of ​​the catheter body is placed within the corresponding target tissue cavity, and accordingly, the tissue boundary distance (e.g., hematoma boundary distance) can be determined based on the ultrasonic detection information.

[0156] In some embodiments, the axial rotation and axial retraction of the catheter body can be performed by a robotic arm or an automatic feeding device instead of manual operation. A pose sensing unit can be located at the joint of the robotic arm and / or the working area at the tail end of the catheter body to acquire information on changes in the catheter's pose. After constructing a local boundary model of the residual hematoma and determining the relative position of the catheter body within the model, the data coupling processing unit can further generate robotic arm control commands. These robotic arm control commands may include, but are not limited to: commands to control the robotic arm to rotate the catheter body axially, commands to retract axially, commands to stop movement, and commands to control the increase, decrease, pause, or stop of the suction negative pressure. After receiving the control commands, the robotic arm drives the catheter body to perform the corresponding rotation, retraction, and suction actions, thereby achieving fully automated control of the catheter operation.

[0157] In another embodiment, the aforementioned spatial sensing technology can be applied to confirm the puncture location of solid lesions. The catheter body can be replaced with a puncture needle core, which is disposed inside a traditional puncture needle. An ultrasonic detection unit is disposed at its distal end, and a pose sensing unit for acquiring the rotation angle and / or axial advance and retreat displacement of the puncture needle core is disposed at its proximal end.

[0158] After the puncture needle reaches the predetermined depth, the operator can rotate and / or advance and retreat the needle core according to the standard operating procedure. The ultrasound detection unit acquires ultrasound detection information of the tissue surrounding the distal end of the needle core at multiple sampling times, and the pose sensing unit acquires pose change information corresponding to each sampling time.

[0159] The data coupling processing unit spatially registers the ultrasound detection information with the corresponding pose change information to form a local boundary relationship model of the tissue surrounding the distal end of the needle core, and determines the positional relationship of the distal end of the needle core relative to the target lesion based on the local boundary relationship model.

[0160] The output unit outputs position confirmation information, adjustment prompt information, or unconfirmation prompt information based on the positional relationship to assist the operator in determining whether to continue the subsequent puncture operation or adjust the position of the puncture needle core.

[0161] Based on the above embodiments, the present invention has at least the following beneficial effects: 1. Upgrade from single-point boundary recognition to intracavity local spatial perception Traditional methods can usually only determine whether the current point is close to the boundary. However, this invention uses a data coupling processing unit to spatially register the ultrasound detection information at each sampling moment with the corresponding pose change information. It accumulates the boundary sampling points obtained at multiple different sampling moments and fits them to a surface to construct a local boundary model of the residual hematoma. This achieves a leap from "single-point distance measurement" to "spatial model construction" and enables continuous and dynamic cognition of the local morphology of the residual hematoma.

[0162] 2. Able to determine the location of the catheter relative to the hematoma

[0163] This invention not only knows "whether this is the boundary", but also calculates the target distance from the position of the distal working area of ​​the catheter body in the global reference system to the local boundary model of the residual hematoma through the data coupling processing unit, and compares it with the preset distance threshold to quantify the position of the catheter body as the hematoma center area, hematoma edge area or high-risk contact area, thus realizing the objective judgment of the relative position of the catheter in the local boundary model of the residual hematoma.

[0164] 3. Able to provide decisions on the direction of suction.

[0165] This invention determines the safety aspiration level based on the area where the catheter body is located through the output unit, and calculates the boundary distances from each direction to the local boundary model of the residual hematoma with the position of the distal working area of ​​the catheter body in the global reference frame as the center. Combining the safety aspiration level and boundary distance, it outputs recommended aspiration directions, warnings for first-level danger directions, warnings for second-level danger directions, emergency warnings for approaching brain tissue, control signals to stop aspiration, and suggestions for withdrawal / rotation, rather than just single-point alarms, providing clear directional operation guidance for the operator.

[0166] 4. It facilitates the realization of local three-dimensional cognition under miniaturized conditions.

[0167] This invention achieves spatial sampling through the natural operation of the catheter body within the hematoma cavity (axial rotation and axial advance and retreat), and performs spatial registration by combining the pose change information obtained by the pose sensing unit. It can complete the local reconstruction of the residual hematoma boundary without relying on complex large-size array probes, which is beneficial for instrument miniaturization and engineering implementation.

[0168] 5. It helps to form a closed loop for safe suction control.

[0169] This invention is suitable not only for prompting systems but also for further development into automatic decompression, aspiration cessation, and aspiration rhythm control systems, facilitating the formation of platform-based products. Based on this, it can be combined with robotic arms or automatic feeding devices to achieve fully automated control of catheter rotation, advance / retreat, and aspiration parameters, providing a technological foundation for the development of robotic surgical systems for cerebral hemorrhage.

[0170] The various embodiments in this specification are described in a progressive manner. Similar or identical parts between embodiments can be referred to mutually. Each embodiment focuses on describing the differences from other embodiments. In particular, system embodiments are basically similar to method embodiments, so the description is relatively simple; relevant parts can be referred to the descriptions in the method embodiments. In the description of this specification, the terms "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the embodiments in this specification. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described can be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification and the features of different embodiments or examples.

[0171] Although the process described above includes multiple operations that occur in a specific order, it should be clearly understood that these processes may include more or fewer operations that can be executed sequentially or in parallel (e.g., using parallel processors or a multithreaded environment).

[0172] The above description is merely an embodiment of this application and is not intended to limit the scope of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of the claims of this application.

[0173] All articles and references disclosed herein, including patent applications and publications, are incorporated herein by reference for various purposes. The term “consistent essentially of” used to describe a combination should include the identified elements, components, parts, or steps, as well as other elements, components, parts, or steps that do not substantially affect the essential novelty of the combination. The use of the terms “comprising” or “including” to describe combinations of elements, components, parts, or steps herein also contemplates embodiments that are substantially composed of such elements, components, parts, or steps. The use of the term “may” herein is intended to indicate that any described attribute included by “may” is optional.

[0174] Multiple elements, components, parts, or steps can be provided by a single integrated element, component, part, or step. Alternatively, a single integrated element, component, part, or step can be divided into multiple separate elements, components, parts, or steps. The use of "a" or "an" to describe an element, component, part, or step does not imply the exclusion of other elements, components, parts, or steps.

[0175] It should be understood that the above description is for illustrative purposes and not for limitation. Many embodiments and applications beyond the provided examples will be apparent to those skilled in the art upon reading the above description. For purposes of completeness, all articles and references, including patent applications and publications, are incorporated herein by reference.

Claims

1. A spatial sensing and safe aspiration catheter system for residual hematoma after cerebral hemorrhage, characterized in that, include: The catheter body, the distal working area of ​​which is used for placement in the hematoma cavity; An ultrasound detection unit is located in the distal working area of ​​the catheter body to acquire ultrasound detection information of the tissue surrounding the distal working area of ​​the catheter body. The pose sensing unit is located in the working area at the tail end of the catheter body and is used to acquire pose change information of the catheter. A data coupling processing unit, connected to the ultrasound detection unit and the pose sensing unit, is used to determine the hematoma boundary distance at each sampling time based on the ultrasound detection information; construct a local boundary model of the residual hematoma based on the hematoma boundary distance at each sampling time and the corresponding pose change information, and determine the relative position of the catheter body in the local boundary model of the residual hematoma; determining the hematoma boundary distance at each sampling time based on the ultrasound detection information includes: performing bandpass filtering and envelope detection processing on the ultrasound detection information to obtain an echo envelope signal; performing sliding time window analysis on the echo envelope signal, and determining that a characteristic echo gap appears at the target sampling time when at least one of the following features is detected: a decrease in echo envelope amplitude, an increase in the spacing between adjacent reflection peaks, or an interruption in echo continuity is detected. The characteristic echo gap represents the ultrasound signal propagation path reaching the hematoma boundary; determining the hematoma boundary distance at the target sampling time based on the flight time corresponding to the characteristic echo gap at the target sampling time and the average sound velocity of brain tissue. An output unit, connected to the data coupling processing unit, is used to output aspiration decision information based on the local boundary model of the residual hematoma and the relative position; the aspiration decision information includes at least one of the following: recommended aspiration direction, danger direction warning, and aspiration control signal; Determining the relative position of the catheter body within the local boundary model of the residual hematoma includes: Obtain the transformation matrix corresponding to the current pose of the catheter body; Obtain the fixed position of the distal working area of ​​the catheter body in the catheter coordinate system. Through the transformation matrix corresponding to the current pose, map the fixed position of the distal working area of ​​the catheter body in the catheter coordinate system to the global reference system to obtain the position of the distal working area of ​​the catheter body in the global reference system. Calculate the distance from the position of the distal working area of ​​the catheter body in the global reference frame to the target distance of the local boundary model of the residual hematoma; Based on the comparison result between the target distance and the preset distance threshold, the region where the catheter body is located in the local boundary model of the residual hematoma is determined as the relative position; The output unit is used to output aspiration decision information based on the local boundary model of the residual hematoma and the relative position, including: The safety aspiration level is determined based on the region where the catheter body is located in the local boundary model of the residual hematoma. Centered on the position of the distal working area of ​​the catheter body in the global reference frame, multiple directions are traversed in the vertical plane of the catheter body axis. For each direction angle, the boundary distance from the position of the distal working area of ​​the catheter body in the global reference frame along the target direction to the local boundary model of the residual hematoma is calculated. Based on the safety suction level and the boundary distance, suction decision information is output.

2. The system according to claim 1, characterized in that, The ultrasonic detection information includes at least one of the following: echo amplitude information, echo envelope characteristics, echo delay, boundary abrupt change characteristics, and detection direction; the pose change information includes at least one of the following: the rotation angle information of the catheter around its own axis and the forward and backward displacement information along its own axis.

3. The system according to claim 1, characterized in that, The catheter body is provided with a suction channel, and the distal working area of ​​the catheter body is provided with at least one suction port. The suction port is used to draw the contents of the hematoma cavity into the suction channel and discharge them out of the body under the action of suction negative pressure. The relative positional relationship between the suction port and the ultrasonic detection unit includes one of the following: A suction port is arranged parallel to and in the same direction as an ultrasonic detection unit; or A suction port is combined with multiple ultrasonic detection units, which are arranged in a circular pattern with equal angles.

4. The system according to claim 1, characterized in that, The process of constructing a local boundary model of the residual hematoma based on the hematoma boundary distance and corresponding pose change information at each sampling time includes: Spatial registration is performed between the hematoma boundary distance at each sampling time and the corresponding pose change information to obtain boundary sampling points with spatial coordinates; Boundary sampling points with spatial coordinates obtained at multiple different sampling times are spatially accumulated to form a boundary point cloud. The boundary point cloud is then fitted with a surface to construct a local boundary model of the residual hematoma.

5. The system according to claim 4, characterized in that, The step of spatially registering the hematoma boundary distance at each sampling time with the corresponding pose change information to obtain boundary sampling points with spatial coordinates includes: A rotation matrix is ​​constructed based on the rotation angle information in the pose change information corresponding to the target sampling time, and a translation vector is constructed based on the forward and backward displacement information in the pose change information corresponding to the target sampling time. The transformation matrix of the target sampling time is composed of the rotation matrix and the translation vector. Obtain the fixed position of the ultrasound detection unit in the catheter coordinate system at the target sampling time, and the unit vector of the detection direction in the catheter coordinate system at the target sampling time; Based on the hematoma boundary distance at the target sampling time, the fixed position of the ultrasound detection unit in the catheter coordinate system, and the unit vector, calculate the position of the boundary sampling point in the catheter coordinate system at the target sampling time. By using the transformation matrix of the target sampling time, the position of the boundary sampling point at the target sampling time in the catheter coordinate system is mapped to the global reference system, forming the boundary sampling point with spatial coordinates at the target sampling time. The global reference system is the coordinate system corresponding to the initial pose of the catheter body.

6. The system according to claim 4, characterized in that, The step of performing surface fitting on the boundary point cloud to construct a local boundary model of the residual hematoma includes: The boundary point cloud is filtered to remove boundary point clouds with confidence scores lower than a preset confidence threshold. The filtered boundary point clouds are classified into hematoma boundary point clouds, brain tissue boundary point clouds, and junctional area point clouds according to the tissue type label. The point cloud of the hematoma boundary is fitted with a surface to obtain the local boundary surface of the residual hematoma, which serves as the local boundary model of the residual hematoma.

7. The system according to claim 1, characterized in that, The preset distance threshold includes a first preset distance threshold and a second preset distance threshold; correspondingly, determining the region where the catheter body is located in the local boundary model of the residual hematoma based on the comparison result between the target distance and the preset distance threshold includes: When the target distance is greater than a first preset distance threshold, it is determined that the catheter body is located in the hematoma center area; When the second preset distance threshold is less than the target distance and the target distance is less than or equal to the first preset distance threshold, it is determined that the catheter body is in the hematoma edge area; When the target distance is less than or equal to the second preset distance threshold, the catheter body is determined to be in a high-risk contact zone; wherein the first preset distance threshold is greater than the second preset distance threshold.

8. The system according to claim 1, characterized in that, The step of outputting suction decision information based on the safety suction level and the boundary distance includes: When the safety suction level is high, the target direction with a boundary distance greater than or equal to a preset safety distance threshold is determined as the recommended suction direction, and the target direction with a boundary distance less than the preset safety distance threshold is determined as the dangerous direction, and a first-level dangerous direction warning is output. When the safety aspiration level is medium, an alert is output for approaching the hematoma boundary, and the target direction where the boundary distance is less than the preset safety distance threshold is determined as the danger direction, and a level two danger direction alert is output. When the safety aspiration level is low, an emergency warning is issued for approaching brain tissue, and a control signal to stop aspiration is also issued.

9. The system according to claim 1, characterized in that, The system also includes a suction control unit and a negative pressure source. The suction control unit is connected to the output unit and the negative pressure source respectively, and is used to receive the suction control signal output by the output unit, and control the negative pressure source according to the suction control signal to adjust the suction negative pressure at the suction port.

10. The system according to claim 9, characterized in that, The suction control unit is configured to perform one or more of the following control actions according to the suction control signal: When the catheter body is in the center of the hematoma and the current aspiration direction is consistent with the recommended aspiration direction, the negative pressure source is controlled to maintain or increase the aspiration negative pressure. When the catheter body is in the hematoma edge area or the current aspiration direction is judged to be a dangerous direction, the negative pressure source is controlled to gradually reduce the aspiration negative pressure to a preset safe negative pressure threshold. When the output approaches the brain tissue emergency warning, the negative pressure source is controlled to suspend suction. When the signal indicating that the hematoma has been cleared is output, the negative pressure source is controlled to stop suction.

11. The system according to claim 1, characterized in that, The system also includes an auxiliary sensing unit, and the data coupling processing unit is further used to fuse the auxiliary information collected by the auxiliary sensing unit with the ultrasonic detection information and pose change information to correct the spatial coordinates of the boundary sampling points.

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