A device and method for locating the spatial position of deep brain lesions

Abstract

The application discloses a brain deep lesion space position positioning device and method in the technical field of neurosurgical instruments, and relates to the technical field of medical devices. The device comprises an ultrasonic probe, a sliding rail fixedly connected with the ultrasonic probe, and a coaxial biopsy needle in sliding connection with the sliding rail. The coaxial biopsy needle comprises a fixed sleeve fixedly connected with the sliding rail, a needle sheath penetrating through the fixed sleeve, a needle sheath limiter connected with the needle sheath, a needle core penetrating through the needle sheath, and a needle core limiter fixedly connected with the needle core. The needle core limiter is in sliding connection with the sliding rail. The application can solve the technical problem that, when facing brain deep lesions, the existing technology has the problems of brain drift in traditional navigation and insufficient path visibility caused by simple ultrasonic guidance, and cannot accurately guide the puncture path.

Description

Technical Field

[0001] This invention relates to the field of neurosurgical instruments, and in particular to a device and method for spatially locating deep brain lesions. Background Technology

[0002] Deep-brain lesions (DBLs) are typically located in the basal ganglia, thalamus, deep white matter, or adjacent important functional areas. They have complex anatomy and are surrounded by vital nerve fiber bundles and vascular structures. Surgical treatment of these lesions requires ensuring complete resection of the lesion while minimizing damage to normal brain tissue and functional areas. Therefore, precise establishment and stable guidance of the puncture path and surgical channel during surgery are key factors in improving surgical safety and efficacy.

[0003] Currently, most clinically used neuronavigation systems rely on preoperative magnetic resonance imaging (MRI) or computed tomography (CT) data for spatial localization. However, during actual surgery, factors such as cerebrospinal fluid release, brain tissue resection, and cerebral edema often lead to varying degrees of brain tissue displacement (i.e., "brain drift"), causing deviations between preoperative images and the actual intraoperative anatomical location. This reduces navigation accuracy and may even result in the risk of mistakenly entering non-lesioned brain tissue.

[0004] Intraoperative ultrasound (IOUS) offers advantages such as real-time imaging, no radiation, low cost, and reusability, showing promising application prospects in the localization and guidance of deep brain lesions. However, due to factors such as the small size of the craniotomy bone window, limited operating space, and unstable needle movement, relying solely on ultrasound imaging is still insufficient to continuously and accurately guide the puncture path, especially when a stable surgical channel needs to be established, where its reliability remains inadequate. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of the prior art and provide a method for spatial location of deep brain lesions. This method can solve the technical problems of brain drift caused by traditional navigation and insufficient path visibility caused by simple ultrasound guidance when dealing with deep brain lesions, which makes it impossible to accurately guide the puncture path.

[0006] To achieve the above objectives, the present invention is implemented using the following technical solution:

[0007] In a first aspect, the present invention provides a spatial location device for deep brain lesions, comprising:

[0008] An ultrasound probe, a slide rail fixedly connected to the ultrasound probe, and a coaxial biopsy needle slidably connected to the slide rail;

[0009] The coaxial biopsy needle includes a fixed sleeve fixedly connected to the slide rail, a needle sheath penetrating the fixed sleeve, a needle sheath limiter connected to the needle sheath, a needle core penetrating the needle sheath, and a needle core limiter fixedly connected to the needle core.

[0010] The needle core limiter is slidably connected to the slide rail.

[0011] Furthermore, the fixing sleeve is connected to the slide rail by a fixing post, and the fixing sleeve is parallel to the slide rail.

[0012] Furthermore, the diameter of the needle sheath limiter is smaller than the diameter of the needle core limiter, and a gap is maintained between the needle sheath limiter and the slide rail.

[0013] Furthermore, it also includes a fixing mechanism for axially fixing the needle core after it has been advanced to a predetermined depth, so that the needle core remains stable during subsequent operations.

[0014] Furthermore, the tip of the needle core has a blunt tip structure with a chamfer angle of 0, which is used to reduce the risk of damage to the brain parenchyma and vascular structures during puncture.

[0015] Secondly, the present invention provides a method for spatial localization of deep brain lesions, comprising:

[0016] Obtain the location of brain lesions based on preoperative imaging, and plan the puncture path and craniotomy location;

[0017] After opening the craniotomy site, the coaxial biopsy needle loaded with navigation and positioning markers is guided to puncture the surface of the brain lesion along the planned puncture path;

[0018] The needle core of the coaxial biopsy needle is fixed and the needle sheath is retracted, leaving the navigation and positioning marker in the puncture path, forming a continuous and clear trajectory on the ultrasound image.

[0019] Furthermore, the configuration process of the navigation and positioning markers includes:

[0020] Mix gelatin sponge particles with a particle size of 710-1000 μm with 1 mL of dye solution until a homogeneous gel consistency is achieved.

[0021] Furthermore, the dye solution comprises methylene blue solution and physiological saline, wherein the ratio of methylene blue solution to physiological saline is 10:2.

[0022] Compared with the prior art, the beneficial effects achieved by the present invention are as follows:

[0023] This invention first proposes a spatial positioning device for deep brain lesions, including an ultrasound probe for real-time ultrasound imaging of brain tissue and puncture path, a slide rail fixedly connected to the ultrasound probe, and a coaxial biopsy needle slidably connected to the slide rail. The coaxial biopsy needle includes a needle sheath and a needle core penetrating the needle sheath. Under the limitation of the needle sheath limiter and the needle core limiter, the relative movement can be guided while maintaining the stability of the puncture path. It can present a clear trajectory with continuous high echo under intraoperative ultrasound, providing a real-time and visualized guidance path for the precise puncture and resection of deep brain lesions, effectively solving the brain drift problem of traditional navigation and the insufficient path visibility problem of simple ultrasound guidance. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of a spatial location device for deep brain lesions provided in an embodiment of the present invention;

[0025] Figure 2 This is a schematic diagram of a coaxial biopsy needle structure in a spatial location device for deep brain lesions provided in an embodiment of the present invention;

[0026] Figure 3 This is a schematic diagram of a coaxial biopsy needle and a slide rail fixation device in a spatial positioning device for deep brain lesions provided in an embodiment of the present invention;

[0027] Figure 4 This is a schematic diagram of the needle core limiter and needle sheath limiter in a spatial positioning device for deep brain lesions provided in an embodiment of the present invention;

[0028] Figure 5 A flowchart illustrating a method for spatially locating deep brain lesions, provided as an embodiment of the present invention;

[0029] Figure 6 The overall flowchart of the ultrasound-based surgical visualization navigation method for deep brain lesions provided by this invention;

[0030] Figure 7 A comparison diagram showing the results of applying the method of this invention with conventional navigation methods;

[0031] Figure 8 A schematic diagram of a case in which the method of the present invention was used to remove a brain tumor;

[0032] Figure 9 This is a schematic diagram of a case in which the method of the present invention was used to remove a metallic foreign body in the brain.

[0033] In the diagram: 1. Ultrasonic probe; 2. Needle core limiter; 3. Needle core; 4. Needle sheath limiter; 5. Needle sheath; 6. Fixing sleeve; 7. First slide rail fixing mechanism; 8. Slide rail; 9. Second slide rail fixing mechanism; 10. Fixing column. Detailed Implementation

[0034] The technical solution of the present invention will be described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the embodiments and specific features in the embodiments are detailed descriptions of the technical solution of the present application, rather than limitations thereof. In the absence of conflict, the embodiments and technical features in the embodiments can be combined with each other.

[0035] In this invention, the term "and / or" is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent three cases: A alone, A and B together, or B alone. Additionally, in this invention, the character " / " generally indicates that the preceding and following related objects have an "or" relationship. Example 1:

[0036] Figure 1 This is a structural diagram of the spatial location device for deep brain lesions in Embodiment 1 of the present invention, specifically including:

[0037] An ultrasound probe 1, a slide rail 8 fixedly connected to the ultrasound probe 1, and a coaxial biopsy needle slidably connected to the slide rail 8.

[0038] The ultrasound probe 1 is preferably a convex array or linear array ultrasound probe used during the operation. It is used to display the position of the puncture needle and its spatial relationship with the deep brain lesion in real time, and to perform real-time ultrasound imaging of the brain tissue and puncture path. Specifically, two types can be used: an L10-3s linear array probe (3-10MHz) for preoperative assessment and a V11-3Ws convex array probe (3-11 MHz) for intraoperative puncture guidance. The L10-3s probe is chosen because of its high resolution and wide near-field field of view, which facilitates accurate preoperative lesion localization and assessment of its spatial relationship. The V11-3Ws probe is chosen for real-time puncture needle guidance because of its wider aperture and deeper penetration capability, which provides superior needle tip visibility and spatial orientation in the transverse and sagittal planes during puncture.

[0039] like Figure 2 , Figure 3 and Figure 4 As shown, the coaxial biopsy needle includes a fixed sleeve 6 fixedly connected to the slide rail 8, a needle sheath 5 passing through the fixed sleeve 6, a needle sheath limiter 4 connected to the needle sheath 5, a needle core 3 passing through the needle sheath 5, and a needle core limiter 2 fixedly connected to the needle core 3.

[0040] The needle core limiter 2 is slidably connected to the slide rail 8. The needle core limiter 2 restricts the axial movement of the needle core 3, and the needle sheath limiter 4 guides or restricts the relative axial movement of the needle sheath 5. The slide rail 8 guides the needle core 3 and needle sheath 5 to move along the puncture path. While keeping the needle core 3 in a fixed position, the relative movement of the needle sheath 5 establishes a stable puncture guide. Both the needle core limiter 2 and the needle sheath limiter 4 have a locking function.

[0041] In this embodiment, the coaxial biopsy needle is preferably 17G×10.0cm in size.

[0042] The fixing sleeve 6 is connected to the slide rail 8 by a fixing post 10, and the fixing sleeve 6 is parallel to the slide rail 8.

[0043] The diameter of the needle sheath limiter 4 is smaller than the diameter of the needle core limiter 2, and a gap is maintained between the needle sheath limiter 4 and the slide rail 8.

[0044] It also includes a first slide rail fixing mechanism 7 and a second slide rail fixing mechanism 9 for fixed connection with the ultrasonic probe 1. The slide rail fixing mechanism is a conventional prior art and only plays a fixing role in this application, so it will not be described in detail here.

[0045] The spatial positioning device for deep brain lesions disclosed in this embodiment also includes a fixing mechanism for axially fixing the needle core 3 by means of a knob locking, a buckle or other equivalent means after the needle core 3 is advanced to a predetermined depth, so that the needle core 3 remains stable during subsequent operations.

[0046] The tip of the needle core 3 is blunt, which is used to reduce the risk of damage to the brain parenchyma and vascular structures during puncture. Example 2:

[0047] Embodiment 2 of the present invention provides a method for spatial location of deep brain lesions. This method can be executed based on the spatial location device for deep brain lesions provided in Embodiment 1, and has the corresponding beneficial effects of the location device. For example... Figure 5 and Figure 6 As shown, it specifically includes:

[0048] Step 1: Obtain the location of the brain lesion based on preoperative imaging, and plan the puncture path and craniotomy location.

[0049] The specific methods for obtaining preoperative images and for determining the location of brain lesions based on preoperative images, as well as for planning the puncture path and craniotomy location, are all existing technologies.

[0050] Step 2: After opening the craniotomy site, guide the coaxial biopsy needle loaded with navigation and positioning markers to puncture the surface of the brain lesion along the planned puncture path;

[0051] Step 3: Fix the core 3 of the coaxial biopsy needle and slowly retract the needle sheath 5 to leave the navigation and positioning marker in the puncture path, forming a clear trajectory with continuous high echo on the ultrasound image.

[0052] It should be noted that during the process of the coaxial biopsy needle puncturing the surface of the brain lesion along the planned puncture path, the coaxial biopsy needle slides along the slide rail 8 as a whole. However, after the needle core 3 is fixed, the movement direction of the needle sheath 5 is opposite to the puncture direction, thereby leaving the navigation and positioning marker in the puncture path.

[0053] The configuration process of the navigation and positioning markers includes:

[0054] Mix gelatin sponge particles with a particle size of 710-1000 μm with 1 mL of dye solution until a homogeneous gel consistency is achieved.

[0055] Regarding the selection of gelatin sponge particle size, we compared two particle size ranges (540–710 μm and 710–1000 μm) with different volumes of staining solution (1.0 mL and 1.5 mL). Excessive staining solution volume (1.5 mL) diluted the gelatin sponge particles, resulting in discontinuous staining along the puncture path. Smaller particles (540–710 μm) also produced unclear trajectories, while 710–1000 μm particles mixed with an appropriate volume of staining solution (such as 1 mL as described in the preparation method) formed a uniform gel consistency and ensured clear visualization of the entire puncture trajectory. Therefore, this invention uses 710–1000 μm gelatin sponge particles. Specifically, this invention involves transferring one vial of gelatin sponge particle embolization agent into a 10 mL syringe. Then, the dye solution (1 mL) is injected into the same syringe and repeatedly mixed with the gelatin sponge particles until a homogeneous gel consistency is achieved.

[0056] The dye solution comprises methylene blue solution and physiological saline in a 10:2 ratio. To determine the optimal ratio, we evaluated three volume ratios of physiological saline to methylene blue (10:1, 10:2, and 10:4). The results showed that a 10:1 ratio resulted in insufficient staining depth, potentially affecting the clear visualization of the puncture trajectory under ultrasound. A 10:4 ratio resulted in excessively deep staining, which could easily spread and contaminate the surgical area, potentially interfering with lesion localization. In contrast, a 10:2 ratio achieved a balanced staining depth, ensuring sufficient visibility while avoiding adverse effects on lesion identification, and was therefore selected as the optimal ratio. Specifically, 0.2 mL of methionine chloride injection (20 mg / 2 mL, commonly known as methylene blue) was mixed with 1 mL of physiological saline to prepare a staining solution, with a total volume of 1.2 mL. It should be noted that the prepared mixture (methylene blue and physiological saline) is 1.2 mL, but only 1 mL is used when mixing with gelatin sponge particles.

[0057] To further evaluate the clinical utility of dye-guided intraoperative ultrasound in neurosurgery, we analyzed key surgical parameters, including operation duration, lesion volume, resection volume, loss rate, and trajectory length.

[0058] (1) Duration of surgery: defined as the time interval from the start of ultrasound guidance to the completion of brain lesion resection.

[0059] (2) Lesion volume: refers to the volume of the pathological brain tissue before surgery, which was measured by two senior radiologists with more than ten years of clinical experience by manually segmenting the region of interest in the preoperative MRI or CT scan. The volume was quantified using 3D Slicer software and the average of the two measurements was recorded.

[0060] (3) Resected volume: refers to the total volume of brain tissue removed during surgery. Postoperative CT scans were analyzed by the same two radiologists using 3D-Slicer with ROI segmentation and the average value was used for analysis.

[0061] (4) Loss rate: the percentage of non-lesion tissue removed to the total removed volume.

[0062] (5) Trajectory length: defined as the straight-line distance from the surface of the skin to the needle insertion path of the lesion.

[0063] All measurements were independently validated by two researchers to ensure reproducibility, and inter-observer variability in volume assessments was kept below 5%.

[0064] To verify the superiority of the method of this invention, we performed brain lesion resection surgeries from January 2024 to October 2025. Patients were randomly stratified into two groups: the Visual neuro-navigation (VN) group and the Conventional neuro-navigation (CN) group. The selection criteria for patients with deep brain lesions were as follows: (a) the lesion was located in a deep brain structure; (b) the ultrasound imaging was clear; and (c) the craniotomy bone window was sufficient to accommodate the ultrasound probe. Exclusion criteria included: (a) poor or unclear ultrasound image quality; (b) the surgical puncture path could not avoid functional areas; (c) there were unavoidable blood vessels in the puncture path, or the lesion was located in the ventricle; and (d) incomplete preoperative or postoperative medical imaging data. MRI or CT scans were obtained before and after surgery, with postoperative CT scans performed within 6 hours after surgery to assess the extent of resection and potential complications. All participants signed written informed consent forms, and all research procedures were approved by the Institutional Ethics Committee of the First Affiliated Hospital of Soochow University (Approval No.: 2024352). Ultimately, thirteen patients with deep brain lesions (5 women, aged 52.38 ± 20.67 years) underwent brain lesion resection surgery using our visualization-based neuronavigation technology. As a control, twelve patients with deep brain lesions received conventional neuronavigation.

[0065] See Figure 7 With the support of this invention, the operation time and brain tissue loss rate of resection surgery for patients with deep brain lesions are significantly reduced. These findings indicate that this invention can well meet the needs of clinical treatment and has great practical value.

[0066] See Figure 8 The patient underwent a left frontal craniotomy under general anesthesia. Dye-guided IOUS is a key navigational tool for precise tumor localization. Specifically, we used a blunt-tipped coaxial biopsy needle pre-loaded with a mixture of methylene blue-stained gelatin sponge to establish the optimal surgical trajectory. Guided by this predefined staining pathway observed under a microscope, we made a 4 cm cortical approach. Atypical tumor tissue was visible at the deepest part of the resection cavity. Methylene blue-enhanced IOUS provided a clear visual pathway, facilitating precise anatomical localization, enabling accurate dissection, and ensuring complete tumor resection.

[0067] Ten days post-surgery, the patient's neurological function recovered well with no residual functional impairment. Post-operative MRI confirmed complete tumor resection, and the patient met all discharge criteria. This case convincingly underscores the crucial role of dye-guided IOUS in neurosurgical tumors. It overcomes the challenges posed by brain displacement, provides visualized and highly precise tumor localization, significantly improves surgical accuracy and safety, and ultimately contributes to better patient outcomes.

[0068] See Figure 9 The patient underwent a left frontal craniotomy under general anesthesia. Intraoperative electrocorticography (EEG) revealed for the first time an epileptogenic focus located in the left medial frontal cortex, characterized by frequent epileptiform discharges. Subsequently, ultrasound guidance allowed real-time, artifact-free visualization of a 5 mm cystic cavity 2 cm deep within the left frontal lobe, containing a metallic foreign body surrounded by glial tissue. The metallic foreign body, along with the EEG-confirmed epileptogenic cortical tissue and adjacent glial scar, was carefully removed while preserving the anterior cerebral artery and its branches.

[0069] The surgical incision healed well postoperatively, and the patient's symptoms improved significantly within a few days. Postoperative recovery was smooth, with no new neurological deficits. The patient was discharged smoothly after confirmation of no seizures and stable neurological function. This case highlights an important clinical understanding: when metallic foreign bodies cause magnetic susceptibility artifacts that contraindicate MRI, ultrasound-guided surgery can be the optimal intraoperative method for precise localization and safe resection.

[0070] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the technical principles of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A device for spatial location positioning of deep brain lesions, characterized in that, include: An ultrasonic probe (1), a slide rail (8) fixedly connected to the ultrasonic probe (1), and a coaxial biopsy needle slidably connected to the slide rail (8); The coaxial biopsy needle includes a fixed sleeve (6) fixedly connected to the slide rail (8), a needle sheath (5) penetrating the fixed sleeve, a needle sheath limiter (4) connected to the needle sheath (5), a needle core (3) penetrating the needle sheath (5), and a needle core limiter (2) fixedly connected to the needle core (3). The coaxial biopsy needle is loaded with navigation and positioning markers. The needle core limiter (2) is slidably connected to the slide rail (8); It also includes a fixing mechanism for axially fixing the needle core (3) after the needle core (3) is advanced to a predetermined depth, so that the needle core (3) remains stable during subsequent operations; The needle core (3) of the coaxial biopsy needle is fixed, and the needle sheath (5) is retracted, leaving the navigation and positioning marker in the puncture path to form a continuous and clear trajectory on the ultrasound image.

2. The spatial location device for deep brain lesions according to claim 1, characterized in that, The fixed sleeve (6) is connected to the slide rail (8) by a fixed post (10), and the fixed sleeve (6) is parallel to the slide rail (8).

3. The spatial location device for deep brain lesions according to claim 1, characterized in that, The diameter of the needle sheath limiter (4) is smaller than the diameter of the needle core limiter (2), and there is a gap between the needle sheath limiter (4) and the slide rail (8).

4. The spatial location device for deep brain lesions according to claim 1, characterized in that, The front end of the needle core (3) is a blunt-tipped structure with a chamfer angle of 0, which is used to reduce the risk of damage to the brain parenchyma and vascular structures during puncture.

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