A tool set for brain surgery navigation and a method of use

Abstract

The application relates to the technical field of brain surgery equipment, in particular to a tool kit special for brain surgery navigation and a use method. In the tool kit, a first magnetic positioning sensor assembly is arranged on a guide needle body, and the guide needle body is fixedly connected with a surgical instrument through a clamping part, so that accurate coordinates and attitude information of a tail end of the surgical instrument in a three-dimensional space can be accurately captured; a second magnetic positioning sensor assembly is arranged on a registration assembly, and the registration assembly is fixed on a patient's head, so that the position and attitude of the patient's head can be accurately captured; the first magnetic positioning sensor assembly is connected with a host computer through a first sensor joint, the second magnetic positioning sensor assembly is connected with the host computer through a second sensor joint, and the guide needle assembly and the registration assembly are synchronously solved in the same magnetic field and the same host computer, so that the relative position of the surgical instrument and the patient's head can be accurately determined, and the smooth and efficient operation of the surgery is facilitated.

Description

Technical Field

[0001] This application relates to the field of neurosurgical equipment technology, and in particular to a special tool kit for neurosurgical navigation and its usage. Background Technology

[0002] In neurosurgical magnetic navigation, the commonly used approach is to track pre-marked magnetic positioning signals, eliminating the need for intraoperative radiation, and its clinical application is becoming increasingly widespread. However, existing magnetic navigation surgical tools can only be adapted to fixed surgical instruments of the corresponding model: when different sizes or types of instruments need to be changed during surgery, either the entire navigation kit must be replaced, or navigation positioning must be abandoned; there are also some adjustable navigation structures, but the adjustment operation is complex and the stability is insufficient, which cannot meet the clinical needs for rapid and accurate use.

[0003] The most recent existing solution: Option A: Optical navigation (reflective ball + stereotactic headframe) – tracks the head but obstructs the surgical field. Requires a headframe to stabilize the patient's head, limiting surgical options. Not compatible with standard surgical instruments.

[0004] Option B: Electromagnetic navigation (coil sensor) – sensitive to metal instruments, requires custom-made instruments. Incompatible with general surgical instruments.

[0005] Option C: Most systems use a "head frame fixation + repeated manual registration" process for the head, which cannot achieve real-time automatic tracking.

[0006] The existing solution has the following problems: it cannot be adapted to different types of surgical instruments that require navigation; changing instruments requires changing the entire set of adaptation parts; it cannot track changes in the patient's head position in real time, and must rely on head frames or repeated manual re-registration; a single tracking system (instrument only OR head only) cannot be used in a closed-loop manner.

[0007] Therefore, there is a need to provide an improved technical solution that addresses the shortcomings of the existing technology. Summary of the Invention

[0008] The purpose of this application is to provide a special tool kit for neurosurgical navigation and a method of using it, so as to solve or alleviate the problems existing in the prior art.

[0009] To achieve the above objectives, this application provides the following technical solution: A special tool kit for navigation in neurosurgery includes a guide pin assembly and a registration assembly. The guide pin assembly is used to be mounted on a surgical instrument to track the position of the instrument's end in real time. The registration assembly is used to be mounted on the patient's head to track the position and posture of the patient's head in real time. The guide needle assembly includes a clamping part and a guide needle body part, which are detachably connected to each other. The clamping part is used to fix the guide needle to the end of the surgical instrument. A first magnetic positioning sensor assembly is provided inside the guide needle body part, and the first magnetic positioning sensor assembly is connected to a first sensor connector through a connecting wire. The registration assembly includes a registration body for fixing to the patient's head. A second magnetic positioning sensor assembly is disposed within the registration body, and the second magnetic positioning sensor assembly is connected to a second sensor connector via a connecting wire.

[0010] In the neurosurgical navigation tool kit described above, preferably, the registration main body is provided with a buckle, and multiple markers are fixed to the patient's head, with the registration main body fixed to one of the markers by the buckle.

[0011] In the neurosurgical navigation tool kit described above, preferably, the registration body is provided with at least one positioning groove.

[0012] In the neurosurgical navigation tool kit described above, preferably, one end of the guide needle body is a circular structure with external threads on the periphery of the circular structure.

[0013] In the neurosurgical navigation tool kit described above, preferably, the other end of the guide needle body is a registration calibration tip.

[0014] In the neurosurgical navigation tool kit described above, preferably, the clamping part includes a first clamping body, a second clamping body, and a torsion spring, wherein the torsion spring is installed between the first clamping body and the second clamping body.

[0015] In the neurosurgical navigation tool kit described above, preferably, one of the first clamp and the second clamp is provided with a thickened portion.

[0016] In the neurosurgical navigation tool kit described above, preferably, the thickened portion is provided with an internal threaded hole, and the external thread of the annular structure on the main body is used for threaded assembly in the internal threaded hole of the thickened portion.

[0017] This application also provides a method for using a neurosurgical navigation tool kit. The method of use is the same as described above, and includes a registration and calibration process for the surgical instruments. This registration and calibration process includes the following steps: Step 1: Place the target surgical instrument into the clamping channel between the first clamp and the second clamp, and connect the first sensor connector to the navigation processing terminal host. Step 2: Use the registration calibration tip to click the positioning groove on the registration body, and the navigation processing terminal host records the pose data P1 of the first magnetic positioning sensor component at this time; Step 3: Keeping the position of the positioning groove in Step 2 unchanged, use the tip of the target surgical instrument to click on the position of the positioning groove in Step 2. The navigation processing terminal host records the pose data P2 of the first magnetic positioning sensor component at this time. Step 4: The navigation processing terminal host calculates the offset of the target surgical instrument end relative to the first magnetic positioning sensor assembly based on the difference between P1 and P2 and the offset of the registration calibration tip relative to the first magnetic positioning sensor 200 stored at the factory, and completes the calculation of the registration conversion matrix.

[0018] The method of using the neurosurgical navigation tool kit described above, preferably, further includes a registration component operation method, which includes the following steps: Step 1: First, fix multiple markers to the patient's head; Step 2: Fix the registration main body to the marker with a snap fastener, and connect it to the navigation processing terminal host through the second sensor connector; Step 3: The navigation processing terminal host continuously receives magnetic field data from the second magnetic positioning sensor component to know the position and posture of the patient's head in real time.

[0019] Compared with the closest prior art, the technical solution of this application has the following beneficial effects: In this tool kit, the guide needle body is equipped with a first magnetic positioning sensor assembly, which is fixedly connected to the surgical instrument via a clamping part, thereby accurately capturing the precise coordinates and posture information of the surgical instrument tip in three-dimensional space. The registration assembly is equipped with a second magnetic positioning sensor assembly, which is fixed to the patient's head, thereby accurately capturing the position and posture of the patient's head. The first magnetic positioning sensor assembly is connected to the host via a first sensor connector, and the second magnetic positioning sensor assembly is connected to the host via a second sensor connector. The guide needle assembly and the registration assembly are synchronously calculated within the same magnetic field and the same host, thereby accurately determining the relative position of the surgical instrument and the patient's head, which helps to ensure the smooth and efficient performance of the surgery.

[0020] The arbitrary pose data collected in real time by the first magnetic positioning sensor component can be quickly converted into the actual spatial position and orientation of the end effector of the target surgical instrument through the transformation matrix. In this embodiment, the entire registration process does not require any additional registration templates or calibration tools. The operator only needs to complete two "clicks" to complete the registration, which is simple to operate and takes very little time, making it especially suitable for emergency surgical scenarios.

[0021] Once the surgical instruments are registered, the navigation tool can move synchronously with the target surgical instrument. An external magnetic field generator continuously constructs a controllable magnetic field space, and the first magnetic positioning sensor component senses the magnetic field parameters at its location in real time, transmitting the collected six-degree-of-freedom pose data to the navigation processing terminal host in real time via the first sensor connector. After receiving the sensor data, the navigation processing terminal host, combined with the completed registration transformation matrix, quickly calculates the real-time spatial position information of the end effector of the target surgical instrument. Subsequently, the navigation processing terminal host performs spatial registration and fusion of the instrument end effector position with preoperative or intraoperative medical images (such as CT, MRI, or ultrasound), and finally presents the navigation positioning results in real time on the display screen in the form of a three-dimensional visual graphical interface for the surgeon's reference.

[0022] Throughout the entire surgical procedure, due to the uniform radial preload provided by the clamping unit, no relative displacement occurs between the navigation tool and the target surgical instrument, ensuring the effectiveness of the registration conversion matrix throughout the entire surgical procedure without the need for repeated re-registration. Attached Figure Description

[0023] The accompanying drawings, which form part of this application, are used to provide a further understanding of this application. The illustrative embodiments and descriptions of this application are used to explain this application and do not constitute an undue limitation of this application. Wherein: Figure 1 This is a schematic diagram of a guide pin assembly provided according to some embodiments of this application; Figure 2 This is a schematic diagram of a registration component provided according to some embodiments of this application.

[0024] Explanation of reference numerals in the attached figures: 100. Clamping part; 110. Clamping channel; 120. Second clamping body; 130. First clamping body; 200. First magnetic positioning sensor assembly; 300. Registration calibration tip; 400. First sensor connector; 500. Guide needle body; 600. Buckle; 700. Second magnetic positioning sensor assembly; 800. Registration body; 900. Second sensor connector; 1000. Positioning groove. Detailed Implementation

[0025] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention are within the scope of protection of the present invention.

[0026] In the description of this invention, the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," and "bottom," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and do not require the invention to be constructed and operated in a specific orientation; therefore, they should not be construed as limitations on the invention. The terms "connected" and "linked" used in this invention should be interpreted broadly. For example, they can refer to a fixed connection or a detachable connection; they can refer to a direct connection or an indirect connection through intermediate components. Those skilled in the art can understand the specific meaning of the above terms according to the specific circumstances.

[0027] The present application will now be described in detail with reference to the accompanying drawings and embodiments. It should be noted that, unless otherwise specified, the embodiments and features described in the embodiments of the present application can be combined with each other.

[0028] According to specific embodiments of this application, such as Figure 1-2 As shown, this application provides a dedicated tool kit for neurosurgical navigation. The tool kit includes a guide pin assembly and a registration assembly. The guide pin assembly is used to be mounted on the surgical instrument to track the position of the surgical instrument tip in real time. The registration assembly is used to be mounted on the patient's head to track the position and posture of the patient's head in real time.

[0029] The guide needle assembly includes a clamping part 100 and a guide needle body part 500. The clamping part 100 and the guide needle body part 500 are detachably connected to each other. The clamping part 100 is used to fix the end of the surgical instrument. A first magnetic positioning sensor assembly 200 is provided inside the guide needle body part 500. The first magnetic positioning sensor assembly 200 is connected to a first sensor connector 400 through a connecting wire.

[0030] The registration assembly includes a registration body 800, which is used to fix the patient's head. A second magnetic positioning sensor assembly 700 is disposed inside the registration body 800, and the second magnetic positioning sensor assembly 700 is connected to a second sensor connector 900 via a connecting wire.

[0031] In this tool kit, a first magnetic positioning sensor assembly 200 is provided on the main body 500 of the guide needle, which is fixedly connected to the surgical instrument via the clamping part 100, thereby accurately capturing the precise coordinates and posture information of the end of the surgical instrument in three-dimensional space; a second magnetic positioning sensor assembly 700 is provided on the registration assembly, which is used to fix it to the patient's head, thereby accurately capturing the position and posture of the patient's head; the first magnetic positioning sensor assembly 200 is connected to the host via the first sensor connector 400, and the second magnetic positioning sensor assembly 700 is connected to the host via the second sensor connector 900. The guide needle assembly and the registration assembly are synchronously calculated in the same magnetic field and the same host, thereby accurately determining the relative position of the surgical instrument and the patient's head, which helps to ensure the smooth and efficient performance of the surgery.

[0032] This tool kit is used in conjunction with a magnetic field generator to construct a magnetic field space. Each magnetic positioning sensor component has a 6-degree-of-freedom sensing function in the magnetic field, which can obtain 3 position information and 3 spatial angle information to achieve real-time positioning. The first magnetic positioning sensor component 200 and the second magnetic positioning sensor component 700 are used to accurately capture and analyze the specific magnetic field parameters of different locations in the space, thereby realizing non-contact high-precision capture of the position of the target to be measured.

[0033] Both the first magnetic positioning sensor assembly 200 and the second magnetic positioning sensor assembly 700 include a magnetic positioning sensor and an internal storage chip. The initial position calibration information of the magnetic positioning sensor is recorded in the internal storage chip. When changing surgical instruments, only the registration and calibration of the new surgical instruments is required to convert the sensor position and attitude information into the position and attitude of the end of the associated surgical instrument. The operation is simple and convenient.

[0034] The registration main body 800 is equipped with a buckle 600, and multiple markers are fixed to the patient's head. The registration main body 800 is fixed to one of the markers via the buckle 600. In this embodiment, the markers contain small steel balls that can be visualized in medical images, and at least one marker is provided with a mounting base, which facilitates the fixing of the registration main body 800 to the mounting base of the marker via the buckle 600. The side of the registration main body 800 facing the patient is curved, so that the curved surface of the registration main body 800 can fit snugly against the patient's head, allowing real-time tracking of the patient's head without the need for a head frame.

[0035] The registration body 800 is provided with at least one positioning groove 1000. In this embodiment, the positioning groove 1000 is used for registration and calibration of surgical instruments before use.

[0036] One end of the guide needle body 500 is a ring structure, and an external thread is provided on the outer periphery of the ring structure. In this embodiment, an external thread is provided on one end of the guide needle body 500 to facilitate a detachable connection between the guide needle body 500 and the clamping part 100.

[0037] The other end of the guide needle body 500 is a registration and calibration tip 300. In this embodiment, the registration and calibration tip 300 has been spatially calibrated using a high-precision coordinate measuring machine when the tool leaves the factory. Its offset relative to the coordinate system of the first magnetic positioning sensor assembly 200 is accurately measured and recorded in the first magnetic positioning sensor assembly 200 built into the guide needle body 500. By performing the registration and calibration operation of the surgical instrument before use through the registration and calibration tip 300, the sensor position and attitude information is converted into the position and attitude of the distal end of the associated surgical instrument.

[0038] The clamping part 100 includes a first clamping body 130, a second clamping body 120, and a torsion spring, with the torsion spring installed between the first clamping body 130 and the second clamping body 120. In this embodiment, a clamping channel 110 is formed between the first clamping body 130 and the second clamping body 120, clamping the first clamping body 130 and the second clamping body 120 onto the surgical instrument, with the surgical instrument located within the clamping channel 110, so that the guide needle assembly and the surgical instrument are assembled together. This clamping part 100 is compatible with various slender tubular surgical instruments of various sizes from 0.5 to 15 mm, covering drainage tubes / puncture needles / biopsy needles / DBS cannulas / SEEG cannulas / endoscopes / balloons / aspirators, etc. Registration and calibration can be completed with just "two clicks" during use, and the combined operation is simple and quick. It can quickly register the position and orientation of the distal end of the combined surgical instrument, converting sensor position and orientation information into the position and orientation of the distal end of the combined surgical instrument for navigation and positioning of the surgical instrument.

[0039] One of the first clamping body 130 and the second clamping body 120 is provided with a thickened part.

[0040] The thickened portion has an internal threaded hole, and the external thread of the annular structure on the main body is used for threaded assembly into the internal threaded hole of the thickened portion. In this embodiment, the external thread on the main body is assembled into the internal thread structure of the thickened portion, realizing a reliable connection between the main body and the clamping portion 100. When it is necessary to disassemble the main body and the clamping portion 100, simply twist the main body in the opposite direction to separate the main body and the thickened portion; wherein, the thickened portion is provided on the first clamping body 130.

[0041] This application also provides a method for using a special tool kit for neurosurgical navigation. The method of use is the same as described above, and includes a registration and calibration procedure for the surgical instruments. The registration and calibration procedure includes the following steps: Step 1: Place the target surgical instrument (such as a puncture needle, drainage tube, or electrocoagulation forceps) into the clamping channel 110 between the first clamp 130 and the second clamp 120, and connect the first sensor connector 400 to the navigation processing terminal host. Step 2, (keeping the relative fixed relationship between the target surgical instrument and the navigation tool unchanged), use the registration calibration tip 300 to click the positioning groove 1000 on the registration body 800, and the navigation processing terminal host records the pose data P1 of the first magnetic positioning sensor assembly 200 at this time; Step 3: Keeping the position of the positioning groove 1000 in Step 2 unchanged, use the tip of the target surgical instrument to click the position of the positioning groove 1000 in Step 2. The navigation processing terminal host records the pose data P2 of the first magnetic positioning sensor component 200 at this time. Step 4: The navigation processing terminal host calculates the offset of the target surgical instrument end relative to the first magnetic positioning sensor assembly 200 (translation vector T1 and rotation matrix R1) based on the difference between P1 and P2 and the offset of the registration calibration tip 300 relative to the first magnetic positioning sensor 200 (translation vector T0 and rotation matrix R0) stored at the factory, and completes the calculation of the registration conversion matrix.

[0042] Subsequently, any pose data collected in real time by the first magnetic positioning sensor component 200 can be quickly converted into the actual spatial position and orientation of the target surgical instrument end effector through the transformation matrix. In this embodiment, the entire registration process does not require any additional registration templates or calibration tools. The operator only needs to complete two "clicks" to complete the registration, which is simple to operate and takes very little time, making it especially suitable for emergency surgical scenarios.

[0043] Once the surgical instruments are registered, the navigation tool can move synchronously with the target surgical instrument. An external magnetic field generator continuously constructs a controllable magnetic field space. The first magnetic positioning sensor component 200 senses the magnetic field parameters at its location in real time and transmits the collected six-degree-of-freedom pose data to the navigation processing terminal host in real time through the first sensor connector 400. After receiving the sensor data, the navigation processing terminal host combines it with the completed registration transformation matrix to quickly calculate the real-time spatial position information of the end effector of the target surgical instrument. Subsequently, the navigation processing terminal host performs spatial registration and fusion of the instrument end effector position with preoperative or intraoperative medical images (such as CT, MRI, or ultrasound), and finally presents the navigation positioning results in a three-dimensional visual graphical interface on the display screen in real time for the surgeon's reference.

[0044] Throughout the entire surgical procedure, due to the uniform radial preload provided by the clamping part 100, no relative displacement occurs between the navigation tool and the target surgical instrument, ensuring the effectiveness of the registration conversion matrix throughout the entire surgical procedure without the need for repeated re-registration.

[0045] The usage method also includes a registration component operation method, which includes the following steps: Step 1: First, fix multiple markers to the patient's head; Step 2: Fix the registration main body 800 to the marker using the buckle 600, and connect it to the navigation processing terminal host via the second sensor connector 900; Step 3: The navigation processing terminal host continuously receives magnetic field data from the second magnetic positioning sensor component 700 to obtain the real-time position and posture of the patient's head. In this embodiment, at any time during the operation, the navigation processing terminal host uses the head posture calculated from the data of the second magnetic positioning sensor component 700 to compensate for the deviation between the preoperative image coordinate system and the current actual head posture, so that the instrument position on the display is always aligned with the actual head of the patient. This ensures that any slight displacement of the patient's head will be automatically tracked, and no re-registration is required during the operation.

[0046] The above description is merely a preferred embodiment of this application and is not intended to limit 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 protection scope of this application.

Claims

1. A specialized tool kit for navigation in neurosurgery, characterized in that, The tool kit includes a guide pin assembly and a registration assembly. The guide pin assembly is used to be mounted on the surgical instrument to track the position of the instrument tip in real time. The registration assembly is used to be mounted on the patient's head to track the position and posture of the patient's head in real time. The guide needle assembly includes a clamping part and a guide needle body part, which are detachably connected to each other. The clamping part is used to fix the guide needle to the end of the surgical instrument. A first magnetic positioning sensor assembly is provided inside the guide needle body part, and the first magnetic positioning sensor assembly is connected to a first sensor connector through a connecting wire. The registration assembly includes a registration body for fixing to the patient's head. A second magnetic positioning sensor assembly is disposed within the registration body, and the second magnetic positioning sensor assembly is connected to a second sensor connector via a connecting wire.

2. The neurosurgical navigation tool kit according to claim 1, characterized in that, The registration body is equipped with a buckle, and multiple markers are fixed to the patient's head. The registration body is fixed to one of the markers by the buckle.

3. The neurosurgical navigation tool kit according to claim 2, characterized in that, The registration body is provided with at least one positioning groove.

4. The neurosurgical navigation tool kit according to claim 3, characterized in that, One end of the main body of the guide needle is a ring structure, and an external thread is provided on the outer periphery of the ring structure.

5. The neurosurgical navigation tool kit according to claim 4, characterized in that, The other end of the guide needle body is the registration calibration tip.

6. The neurosurgical navigation tool kit according to claim 5, characterized in that, The clamping part includes a first clamping body, a second clamping body, and a torsion spring, with the torsion spring installed between the first clamping body and the second clamping body.

7. The neurosurgical navigation tool kit according to claim 6, characterized in that, One of the first clamping body and the second clamping body is provided with a thickened part.

8. The neurosurgical navigation tool kit according to claim 7, characterized in that, The thickened portion is provided with an internal threaded hole, and the external thread of the annular structure on the main body is used for threaded assembly in the internal threaded hole of the thickened portion.

9. A method of using a special tool kit for navigation in neurosurgery, characterized in that, The method of use is the method of using the neurosurgical navigation tool kit according to claim 8, the method of use includes the registration and calibration of surgical instruments, the registration and calibration of which includes the following steps: Step 1: Place the target surgical instrument into the clamping channel between the first clamp and the second clamp, and connect the first sensor connector to the navigation processing terminal host. Step 2: Use the registration calibration tip to click the positioning groove on the registration body, and the navigation processing terminal host records the pose data P1 of the first magnetic positioning sensor component at this time; Step 3: Keeping the position of the positioning groove in Step 2 unchanged, use the tip of the target surgical instrument to click on the position of the positioning groove in Step 2. The navigation processing terminal host records the pose data P2 of the first magnetic positioning sensor component at this time. Step 4: The navigation processing terminal host calculates the offset of the target surgical instrument end relative to the first magnetic positioning sensor assembly based on the difference between P1 and P2 and the offset of the registration calibration tip relative to the first magnetic positioning sensor 200 stored at the factory, and completes the calculation of the registration conversion matrix.

10. The method of using the neurosurgical navigation tool kit according to claim 9, characterized in that, The method of use also includes a registration component operation method, which includes the following steps: Step 1: First, fix multiple markers to the patient's head; Step 2: Fix the registration main body to the marker with a snap fastener, and connect it to the navigation processing terminal host through the second sensor connector; Step 3: The navigation processing terminal host continuously receives magnetic field data from the second magnetic positioning sensor component to know the position and posture of the patient's head in real time.

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