Deep brain lesion spatial position positioning device and method

Abstract

The invention discloses a deep brain lesion spatial position positioning device and method in the technical field of neurosurgical operating instruments. The device comprises an ultrasonic probe, a sliding rail fixedly connected with the ultrasonic probe and a coaxial biopsy needle slidably connected with the sliding rail. The coaxial biopsy needle comprises a fixing sleeve fixedly connected with the sliding rail, a needle sheath penetrating through the fixing 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. And the needle core limiter is connected with the slide rail in a sliding manner. According to the method, the technical problems that in the prior art, when deep brain lesion occurs, path visibility is insufficient due to brain drifting of traditional navigation and pure ultrasonic guidance, and a puncture path cannot be accurately guided can be solved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of neurosurgical instruments, in particular to a brain deep lesion spatial position positioning device and method. BACKGROUND

[0002] Deep-brain-lesions (DBL) are usually located in the basal ganglia region, thalamic region, deep white matter or adjacent important functional areas, and the anatomical structure is complex, surrounded by important neural fiber bundles and vascular structures. The surgical treatment of such lesions needs to minimize the damage to normal brain tissue and functional areas while ensuring complete resection of the lesions. Therefore, the accurate establishment and stable guidance of the puncture path and surgical channel during the operation are one of the key factors to improve the safety and efficacy of the operation.

[0003] The commonly used clinical navigation system is based on preoperative magnetic resonance imaging (MRI) or computed tomography (CT) data for spatial positioning. However, during the actual operation, due to factors such as cerebrospinal fluid release, brain tissue resection, and brain edema, different degrees of brain tissue displacement (i.e., the "brain shift" phenomenon) often occur, resulting in a deviation between the preoperative image and the actual anatomical position during the operation, thereby reducing the navigation accuracy and even causing the risk of entering non-lesion brain tissue.

[0004] Intraoperative-ultrasound (IOUS) has the advantages of real-time imaging, no radiation, low cost, and reusability, and shows good application prospects in the positioning and guidance of brain deep lesions. However, due to the small skull window, limited operation space, and unstable movement of the puncture needle, it is still difficult to continuously and accurately guide the puncture path solely relying on ultrasound imaging, especially when a stable surgical channel needs to be established, its reliability is still insufficient. SUMMARY

[0005] The purpose of the present application is to overcome the deficiencies in the prior art, and to provide a brain deep lesion spatial position positioning method, which can solve the technical problems of traditional navigation brain shift and insufficient path visibility caused by pure ultrasound guidance, and cannot accurately guide the puncture path when facing brain deep lesions.

[0006] To achieve the above purpose, the present application adopts the following technical scheme: In a first aspect, the present application provides a brain deep lesion spatial position positioning device, comprising: an ultrasonic probe, a slide rail fixedly connected with the ultrasonic probe, and a coaxial biopsy needle in sliding connection with the slide 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.

[0007] Further, the fixed sleeve and the sliding rail are connected through a fixed column, and the fixed sleeve is parallel to the sliding rail.

[0008] Further, the diameter of the needle sheath limiter is smaller than that of the needle core limiter, and a gap is kept between the needle sheath limiter and the sliding rail.

[0009] Further, the coaxial biopsy needle further comprises a fixing mechanism for axially fixing the needle core after the needle core is advanced to a predetermined depth, so that the needle core remains stable and immovable during subsequent operations.

[0010] Further, the front end of the needle core is a blunt structure with a chamfer angle of 0, which is used to reduce the risk of damage to the brain parenchyma and vascular structure during puncture.

[0011] In a second aspect, the present application provides a method for positioning the spatial position of brain deep lesions, comprising: acquiring the position of brain lesions determined based on preoperative images, planning a puncture path and a craniotomy position; After craniotomy at the craniotomy position, control the coaxial biopsy needle loaded with a navigation positioning marker to puncture along the planned puncture path to the surface of the brain lesion position; Control the needle core fixation of the coaxial biopsy needle, retract the needle sheath, and leave the navigation positioning marker in the puncture path to form a clear and continuous track on the ultrasound image.

[0012] Further, the configuration process of the navigation positioning marker comprises: Mix the gelatin sponge particles with a particle size of 710-1000 μm and 1 mL of dye solution until a homogeneous gel-like consistency is achieved.

[0013] Further, the dye solution comprises methylene blue solution and physiological saline, and the ratio of the methylene blue solution and the physiological saline is 10:2.

[0014] Compared with the prior art, the present application has the following beneficial effects: The application firstly provides a brain deep lesion spatial position positioning device, which comprises an ultrasonic probe for real-time ultrasonic imaging of brain tissue and a puncture path, a sliding rail fixedly connected with the ultrasonic probe and a coaxial biopsy needle in sliding connection with the sliding rail, and the coaxial biopsy needle comprises a needle sheath and a needle core penetrating through the needle sheath. The relative motion of the needle sheath and the needle core can be guided under the premise of keeping the puncture path stable under the limiting of the needle sheath limiter and the needle core limiter, and a clear track with continuous high echo can be presented under the intraoperative ultrasound, which provides a real-time and visual guiding path for the accurate puncture and resection of deep brain lesions, effectively solves the brain drift problem of traditional navigation and the path visibility problem of simple ultrasonic guidance. BRIEF DESCRIPTION OF DRAWINGS

[0015] Figure 1 A structural schematic diagram of a brain deep lesion spatial position positioning device provided by the embodiment of the application is provided. Figure 2 A coaxial biopsy needle structural schematic diagram in the brain deep lesion spatial position positioning device provided by the embodiment of the application is provided. Figure 3 A coaxial biopsy needle and sliding rail fixing device schematic diagram in the brain deep lesion spatial position positioning device provided by the embodiment of the application is provided. Figure 4 A needle core limiter and needle sheath limiter schematic diagram in the brain deep lesion spatial position positioning device provided by the embodiment of the application is provided. Figure 5 A flowchart of a brain deep lesion spatial position positioning method provided by the embodiment of the application is provided. Figure 6 A whole flowchart block diagram of the brain deep lesion surgery visual navigation method based on ultrasound provided by the application is provided. Figure 7 A comparison result diagram of the application method and the conventional navigation method is provided. Figure 8 A case schematic diagram of resecting brain tumor by the application method is provided. Figure 9 A case schematic diagram of resecting intracerebral metal foreign body by the application method is provided.

[0016] In the figure: 1, ultrasonic probe; 2, needle core limiter; 3, needle core; 4, needle sheath limiter; 5, needle sheath; 6, fixing sleeve; 7, first sliding rail fixing mechanism; 8, sliding rail; 9, second sliding rail fixing mechanism; 10, fixing column. DETAILED DESCRIPTION

[0017] The technical solutions of the present application will be described in detail below with reference to the drawings and specific embodiments. It should be understood that the embodiments and specific features in the embodiments are detailed descriptions of the technical solutions of the present application, and are not limitations of the technical solutions of the present application. In the case of no conflict, the technical features in the embodiments and the embodiments can be combined with each other.

[0018] In the present application, the term "and / or" is only used to describe the association relationship of the associated objects, which means that there can be three relationships, for example, A and / or B, which can represent three cases of A alone, A and B, and B alone. In addition, the character " / " in the present application generally represents that the associated objects before and after are in an "or" relationship. Embodiment one:

[0019] Figure 1 is a structural diagram of the brain deep lesion spatial position positioning device in the first embodiment of the present application, which specifically comprises: An ultrasonic probe 1, a sliding rail 8 fixedly connected with the ultrasonic probe 1, and a coaxial biopsy needle in sliding connection with the sliding rail 8.

[0020] Preferably, the ultrasonic probe 1 is a convex array or linear array ultrasonic probe used in surgery, which is used to display the position of the puncture needle and its spatial relationship with the brain deep lesion in real time, and to perform real-time ultrasonic imaging on the brain tissue and the puncture path. Specifically, two types can be used: L10-3s linear array probe (3-10 MHz) for preoperative evaluation, and V11-3Ws convex array probe (3-11 MHz) for intraoperative puncture guidance. The L10-3s probe is selected because of its high resolution and wide near-field view, which facilitates accurate preoperative positioning of the lesion and evaluation of its spatial relationship. The V11-3Ws probe is selected for real-time puncture needle guidance because of its wider aperture and deeper penetration capability, which can provide superior needle tip visibility and spatial orientation in the transverse and sagittal planes during puncture.

[0021] As shown in Figure 2 , Figure 3 and Figure 4 , the coaxial biopsy needle comprises a fixed sleeve 6 fixedly connected with the sliding rail 8, a needle sheath 5 penetrating through the fixed sleeve 6, a needle sheath limiter 4 connected with the needle sheath 5, a needle core 3 penetrating through the needle sheath 5, and a needle core limiter 2 fixedly connected with the needle core 3.

[0022] The needle core limiter 2 is in sliding connection with the slide rail 8, the needle core limiter 2 is used for limiting the axial movement of the needle core 3, the needle sheath limiter 4 is used for guiding or limiting the axial relative movement of the needle sheath 5, and the slide rail 8 is used for guiding the movement of the needle core 3 and the needle sheath 5 along the puncture path direction. In the case of keeping the position of the needle core 3 fixed, the relative movement of the needle sheath 5 is guided to establish stable puncture guidance. The needle core limiter 2 and the needle sheath limiter 4 both have the function of locking position.

[0023] In the embodiment, the specification of the coaxial biopsy needle is preferably 17G*10.0cm.

[0024] The fixed sleeve 6 is connected between the slide rail 8 through the fixed column 10, and the fixed sleeve 6 is parallel to the slide rail 8.

[0025] The diameter of the needle sheath limiter 4 is smaller than the diameter of the needle core limiter 2, and a gap is kept between the needle sheath limiter 4 and the slide rail 8.

[0026] The first slide rail fixing mechanism 7 and the second slide rail fixing mechanism 9 for fixed connection with the ultrasonic probe 1 are also included, the slide rail fixing mechanism belongs to the conventional prior art, and only plays a fixing role in the application and will not be described here.

[0027] The brain deep lesion spatial position positioning device disclosed in the embodiment further includes a fixing mechanism for fixing the needle core 3 in the axial direction after the needle core 3 is pushed to a predetermined depth, so that the needle core 3 remains stable and immovable in the subsequent operation process.

[0028] The front end of the needle core 3 is a blunt structure, which is used to reduce the risk of damage to the brain parenchyma and vascular structure during puncture. Embodiment two

[0029] The brain deep lesion spatial position positioning method provided in the embodiment two can be executed based on the brain deep lesion spatial position positioning device provided in the embodiment one, and has the beneficial effects of the positioning device. As shown in Figure 5 and Figure 6 Specifically, the method comprises the following steps: Step one: obtaining the brain lesion position determined based on preoperative images, planning the puncture path and craniotomy position.

[0030] Wherein, how to obtain the preoperative images and how to determine the brain lesion position based on the preoperative images, plan the puncture path and craniotomy position all belong to the prior art; Step two: after craniotomy at the craniotomy position, control the coaxial biopsy needle loaded with navigation positioning markers to puncture along the planned puncture path to the surface of the brain lesion position. 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.

[0031] 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.

[0032] The configuration process of the navigation and positioning markers includes: 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] (1) Duration of surgery: defined as the time interval from the start of ultrasound guidance to the completion of brain lesion resection.

[0037] (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.

[0038] (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.

[0039] (4) Loss rate: the percentage of non-lesion tissue removed to the total removed volume.

[0040] (5) Trajectory length: defined as the straight-line distance from the surface of the skin to the needle insertion path of the lesion.

[0041] All measurements were independently validated by two researchers to ensure reproducibility, and inter-observer variability in volume assessments was kept below 5%.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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 needle core limiter (2) is slidably connected to the slide rail (8).

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, 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.

5. 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.

6. A positioning method for a spatial positioning device for deep brain lesions according to any one of claims 1-5, characterized in that, include: Obtain the location of brain lesions based on preoperative imaging, and plan the puncture path and craniotomy location; 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; 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.

7. The method for spatial localization of deep brain lesions according to claim 6, characterized in that, The configuration process of the navigation and positioning markers includes: 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.

8. The method for spatial localization of deep brain lesions according to claim 7, characterized in that, The dye solution comprises methylene blue solution and physiological saline, wherein the ratio of methylene blue solution to physiological saline is 10:2.

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