AU2019412420B2

AU2019412420B2 - Surgical navigation system

Info

Publication number: AU2019412420B2
Application number: AU2019412420A
Authority: AU
Inventors: Chenlong CHU; Meng HAN; Zan LI; Wenbo Liu; Li Wen
Original assignee: Sinovation Beijing Medical Tech Co Ltd
Current assignee: Sinovation Beijing Medical Technology Co Ltd
Priority date: 2018-12-29
Filing date: 2019-12-27
Publication date: 2023-06-22
Anticipated expiration: 2039-12-27
Also published as: WO2020135785A1; CN110946653A; CN113397706A; CN110946653B; CN216021360U; AU2019412420A1

Abstract

A surgical navigation system, comprising: a spatial positioning module that is used for guiding the movement path of medical instruments; a workstation that contains pre-loaded software used for generating a three-dimensional image on the basis of a medical image, receiving information, generating a surgical plan, sending instructions to the spatial positioning module, and virtually fusing surgical tools matching the spatial positioning module into the formed three-dimensional image; the workstation comprises a communication interface, a processor, a display device (900) and an input device (800), the display device (900) being used to display a software interface, and the input device (800) being used to input user commands. The described surgical navigation system may also comprise positioning markers, or also comprise a tracking module (B) and an ultrasound module. The surgical navigation system responds quickly, is simple to operate, has a wide application range, and may be used for a plurality of surgical operations.

Description

SURGICAL NAVIGATION SYSTEM CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority of the Chinese Patent Application No. 201811644912.7, filed on December 29, 2018, and entitled "SURGICAL NAVIGATION SYSTEM", the content of which is incorporated herein by reference in its entirety for all purposes.

TECHNICAL FIELD

[0002] The present invention relates to the technical field of medical apparatuses, in particular to a surgical navigation system.

BACKGROUND

[0003] Any discussion of the prior art throughout the specification should in no way be considered as an admission that such prior art is widely known or forms part of common general knowledge in the field.

[0004] Puncture surgery is one of the common procedures in clinical surgery, and specific examples thereof include but are not limited to hematoma aspiration, cyst aspiration, edema aspiration, tissue biopsy, continuous administration, etc.

[0005] In traditional puncture surgery, a puncture needle is generally positioned by determining a position of a lesion based on a patient's CT image, and then a doctor roughly determines a puncture path based on the position of the lesion to perform puncture. For safety reasons, a CT scan is usually performed every lcm-2cm of needle insertion to correct a moving direction of the puncture needle. Therefore, throughout the surgical procedure, the patient needs to receive multiple CT scans, suffering from a relative great amount of radiation. With respect to this manner, the design of the puncture path relies heavily on the doctor's experience and judgment, and there is a risk of puncturing blood vessel and causing hemorrhage. For a small and deep lesion, there is a risk of a large error and failing to reach the lesion.

[0006] The surgical navigation system has brought great convenience to medical procedures since its advent, but there are still problems such as relying on an operator and poor accuracy.

SUMMARY

[0007] It is an object of the present invention to overcome or substantially ameliorate one or more of the disadvantages of prior art, or at least to provide a useful alternative.

[0008] In view of this, in order to solve the problems in the prior art, the present invention proposes a surgical navigation system, which has advantages of rapid response, accurate navigation and positioning, simple operation, and a low price.

[0009] The present invention provides a surgical navigation system, including: a workstation, wherein the workstation includes a communication interface, a processor, a display device, and an input device, and wherein the communication interface is configured for communication connection, the processor contains pre-loaded software, the display device is configured to display an interface of the software, and the input device is configured to input a command from a user; and a spatial positioning module, wherein the spatial positioning module includes: a connection fixing device configured to fix a structure connected to a distal end of the connection fixing device; a position adjusting device including a base, a power structure, and at least two sets of moving assemblies, wherein each set of moving assemblies contains two components capable of moving relatively, and the power structure can prompt the two components to move relative to each other; a controlling device configured to regulate the power structure and carry out the communication connection; a guiding device containing a through hole, configured to guide a surgical instrument; and a position feedback device configured to calibrate a distance change caused by the power structure; and wherein, the position adjusting device is connected to the distal end of the connection fixing device, and the guiding device is hinged to the two sets of moving assemblies of the position adjusting device via a first connector and a second connector, respectively, the two sets of moving assemblies driving the first connector and the second connector to move in two dimensions relative to the base, and the position feedback device calibrating the distance change caused by the power structure, so that the guiding device connected with the first connector and the second connector reaches a desired position based on movements of the two sets of moving assemblies, and a position of a part of the spatial positioning module is detectable in medical imaging, thereby positioning the through hole of the guiding device in a three-dimensional space.

[0010] In the surgical navigation system of the present invention, the pre-loaded software in the processor may generate a 3D image based on existing medical image (such as CT and MRI) data, or receive and display a generated 3D image, and virtually display the guiding device and a movement path of the surgical instrument guided within the guiding device in a three-dimensional image. Blood vessels may be displayed in the three-dimensional image for reference by the user.

[0011] In the surgical navigation system of the present invention, the connection fixing device is any structure capable of fixing the position adjusting device relative to a patient, such as a universal arm, a bracket, and a multi-degree-of-freedom mechanical connection structure. In an embodiment, the connection fixing device is a universal arm including at least one joint, preferably a universal arm including three or more joints. In a preferred embodiment, the universal arm includes a fastening structure, a supporting arm, a firstjoint, a first adjusting arm, a secondjoint, a second adjusting arm, a third joint, and a connecting arm. The fastening structure is connected to a wall, a stage, a hospital bed, etc., to support for and approximately position the spatial positioning module. The connecting arm is connected to the position adjusting device.

[0012] In a first aspect of the present invention, a position of a part of the spatial positioning module may be monitored in medical imaging. For example, a position and contour of the base, the guiding device or a part of the foregoing may be monitored in magnetic resonance imaging (MRI), X-ray computed tomography (CT), or X-ray imaging. In an embodiment, the guiding device is a cylinder with a known size, when the guiding device together with the patient are medically imaged in a relatively fixed position, a contour and position of the guiding device may be displayed in the medical imaging, so as to calculate coordinates of the guiding device in the coordinate system of the three-dimensional image; and the position of the guiding device is adjusted based on the coordinates. In another embodiment, a part of the guiding device is made of a material whose position and contour may be clearly viewed in the medical imaging, such as two arc segments that are arranged in parallel and have different lengths. Based on this, the coordinates and spatial position of the guiding device can be calculated. It should be understood by those skilled in the art that, such a structure may have various designs, as long as the position of the guiding device relative to a target site can be determined by the structure. The guiding device contains a through hole, and the through hole may have different inner diameters as required to cooperate with different surgical instruments.

[0013] In a second aspect, the surgical navigation system of the present invention further includes a positioning marker. There may be multiple options for the positioning marker, for example, a marker whose position may be monitored in the medical imaging, a marker whose position may be monitored by the tracking module, etc. Medical imaging methods include various existing suitable methods, such as magnetic resonance imaging (MRI), X-ray computed tomography (CT), or X-ray imaging. The marker whose position can be monitored in the medical imaging may have a variety of different geometric shapes and materials, and may have a variety of mounting configurations, including being fixedly mounted or being detachably mounted. The number of the markers is not limited as long as the spatial position of the guiding device can be determined, and usually the number of the markers is three or more. For example, the marker may be mounted on the base, the guiding device, or a connector connected to the guiding device. In the case that the positioning marker is mounted on the base, since the spatial position of the guiding device needs to be calculated by the power structure, in order to ensure the accuracy of a distance change, a position feedback device is mounted to calibrate the change in the position caused by the power structure. In the case that the positioning marker is mounted on the guiding device, the positioning is the most direct. In the case that the positioning marker is mounted on the connector, since there are two connectors, it is necessary to determine each connector separately, and then to determine the spatial position of the guiding device by the positions of the connectors.

[0014] In the case that the surgical navigation system of the present invention includes a marker whose position can be monitored via a tracking module, the surgical navigation system further includes the tracking module. The tracking module may be an optical tracking module, an electromagnetic tracking module, and the like. In the case that the positioning marker of the surgical navigation system of the present invention is an optical positioning marker whose position can be detected by the optical tracking module, the surgical navigation system includes the optical positioning marker/a positioning fitting, an optical tracking module, and a reference mark. The optical positioning marker may be various markers that are optically recognized, such as commonly used infrared-reflecting spherical markers, patterns with corner points, as long as these markers can cooperate with the corresponding tracking module. The optical positioning marker may also be mounted on a rigid structure to form a positioning fitting, in which the optical positioning marker is arranged in a unique spatial distribution, and thus a unique coordinate system can be determined. In an embodiment, the positioning fitting is of a rigid structure equipped with four spherical optical positioning markers, and includes a taper portion and a body portion. The optical positioning marker may actively emit light or passively reflect light. During use, the taper portion of the positioning fitting is inserted into a through hole of a guiding catheter. The light emitted or reflected by the optical positioning marker is captured by a camera, and then a position of the positioning fitting can be determined by calculation; and thus, a spatial position of the guiding catheter and a spatial position of the through hole of the guiding catheter can be determined. The reference mark cooperates with the positioning fitting for coordinate system transformation. The reference mark is connected to a site to be operated, and a fixed positional relationship therebetween is maintained during a surgical procedure. For example, the reference mark may be connected to a patient's head by a head frame, a bone nail, etc., which has been mounted on a patient's skull. After a host of the present invention generates a three-dimensional image, calibration is performed taking the reference mark as a basic coordinate system, so that the positioning fitting and the guiding device can be virtually displayed in the three-dimensional image. If the position of the target site and the position of the reference mark change together during the surgical procedure, the relative position of the positioning fitting in the three-dimensional image may be re-determined based on the change of the reference mark, and is adjusted to a desired position as required. The tracking module has different structures dependent on the positioning marker used. For example, in the case that an electromagnetic positioning marker is used, the tracking module is an electromagnetic positioning device; in the case that a spherical light-reflecting marker is used, the tracking module contains a light-emitting and image-capturing unit; and in the case that a pattern with corner points is used as an optical positioning marker, the tracking module contains an image-capturing unit, preferably a binocular image-capturing unit.

[0015] In an example according to the second aspect, the tracking module includes: a movable baseplate, a bracket, and a light-emitting and image-capturing unit. The movable baseplate is equipped with wheels to be moved freely, and preferably, in one embodiment, the movable baseplate is equipped with four wheels and contains a stop structure. After the movable baseplate is moved to a desired position, the position of the movable baseplate may be prevented by the stop structure from being changed during the surgical procedure. The bracket consists of a pillar, a first bracket joint, a connecting rod, a second bracket joint, a first adjusting rod, a third bracket joint, and a second adjusting rod. The position (namely, the height and the angle) of the light-emitting and image-capturing unit can be adjusted by the bracket, so that a target area is within an optimum operating range of the light-emitting and image-capturing unit. The workstation includes: a workstation movable baseplate, a host, an input device, and a display. The workstation movable baseplate is equipped with wheels and a corresponding stop structure, and thus can move. When the workstation movable baseplate reaches a desired position, the workstation movable baseplate is fixed by the stop structure to prevent the position of the workstation movable baseplate from being changed during the surgical procedure. The host contains a processor and a communication interface. The processor may complete a three-dimensional reconstruction based on a medical image, receive information collected by the tracking module by the communication interface, generate a surgical plan, send an instruction to the spatial positioning module, virtually fuse a surgical tool matched with the spatial positioning module into the formed three-dimensional image, and display it to a user via the display. The input device is a keyboard, a mouse, or a voice input device.

[0016] In a third aspect, the surgical navigation system of the present invention also includes a tracking module and an ultrasound module. The tracking module at least includes an image acquiring device, such as a camera, preferably a binocular camera, a positioning marker (or a positioning fitting) and a reference marker, and further may include a light-emitting unit. The ultrasound module includes an ultrasound probe and an ultrasound diagnostic apparatus. The ultrasound probe is mounted with a positioning marker. The positioning marker or a positioning fitting containing the positioning marker may be fixedly mounted or detachably connected to the ultrasound probe. The ultrasound diagnostic apparatus may exist independently, or be integrated into the host of the surgical navigation system.

[0017] In an embodiment according to the third aspect, the surgical navigation system of the present invention includes a workstation, a spatial positioning module, a tracking module, and an ultrasound module. The workstation and the spatial positioning module are basically as described above. The tracking module includes a light-emitting unit, an image-capturing unit, a positioning fitting, and a reference mark. Each of the positioning fitting and the reference mark has several light-reflecting spherical positioning markers, and these markers have a unique structure design, so that the spatial positions of the positioning fitting and the reference mark can be uniquely determined. The positioning fitting may be independent, for example, the positioning fitting may include a taper portion and a body portion. The taper portion is configured to be detachably inserted into the through hole of the guiding device. The body portion contains several optical positioning markers, and the spatial position of the positioning fitting may be determined by reflecting light by these optical positioning markers. The positioning fitting may also be a part of the guiding device, and be integrated with the guiding device. The reference mark adopts the same optical positioning markers as those of the positioning fitting, and these markers also have a unique shape, so that the spatial position of the reference mark can be uniquely determined. During use, the reference mark has a definite relative position relationship with the site to be operated. For example, the reference mark is connected to the site to be operated by, for example, a bone nail, a head frame, etc., which has been fixed on the patient. A coordinate system of the tracking module is established based on the reference mark. The tracking module simultaneously tracks the positioning fitting, the reference mark and the ultrasound probe. The ultrasound probe uses a positioning fitting similar to the positioning fitting of the guiding device. The positioning fitting of the ultrasound probe may be integrated within the ultrasound probe, and also may be detachable, as long as the positioning fitting has a definite imaging position relationship with the ultrasound probe. The ultrasound diagnostic apparatus transmits data scanned by the ultrasound probe to the workstation. The workstation subjects the ultrasound image to coordinate transformation by taking the reference mark as a reference and displays by the display device a virtual graphic of the guiding catheter in the ultrasound image. The workstation plans the position of the guiding catheter according to requirements, and sends an instruction to the spatial positioning module to enable the guiding catheter to move to a desired position and direction.

[0018] In another embodiment according to the third aspect, the surgical navigation system of the present invention includes a workstation, a spatial positioning module, a tracking module, and an ultrasound module. The workstation and the spatial positioning module are basically as described above. The tracking module only includes an image-capturing unit. The positioning fitting has several corner points, so that the spatial position of the positioning fitting can be uniquely determined by the image-capturing unit and the software loaded by the workstation. The ultrasound probe has the same positioning markers as those of the positioning fitting, namely corner points. The ultrasound diagnostic apparatus transmits data scanned by the ultrasound probe to the workstation. The workstation, by taking the ultrasound probe as a reference, calibrates by the tracking module the position of the positioning fitting in the coordinate system of the positioning markers of the ultrasound probe, and then transforms a coordinate system of the positioning fitting and a coordinate system of the ultrasound image based on a fixed position relationship between the ultrasound probe and the positioning markers thereof. The workstation may virtually fuse the guiding catheter or the medical instrument with the ultrasound image, and display it on the display device.

[0019] In yet another embodiment according to the third aspect, the surgical navigation system of the present invention includes a workstation, a spatial positioning module, a tracking module, and an ultrasonic module. The tracking module is an electromagnetic tracking module. The ultrasonic module contains a magnetic positioning marker. The spatial positioning module contains a magnetic positioning marker. The electromagnetic tracking module contains a magnetic field generating device and a reference mark, and may simultaneously track positions of the spatial positioning module, the ultrasonic module, and the reference mark. The reference mark, when in use, is closely connected to skin near a site to be detected, and the electromagnetic tracking module tracks a change in the position of the reference mark for calibration to eliminate a tracking error caused by tissue displacement. The electromagnetic tracking module generates an electromagnetic field (a first signal), which is sensed by the magnetic positioning marker. The magnetic positioning marker generates a second signal in response to the first signal. The host then determines the positions of the spatial positioning module, the ultrasound module, and the reference mark based on the second signal.

[0020] The ultrasound image is subjected to coordinate transformation, and the virtual graphic of the guiding catheter is fused with the ultrasound image by the display device. The workstation plans the position of the guiding catheter according to requirements, and sends an instruction to the spatial positioning module to enable the guiding catheter to move to a desired position and direction.

[0021] In the surgical navigation system of the present invention, the power structure is a motor. Preferably, the motor is a non-magnetic motor, and may be used in a magnetic resonance environment. That is, the surgical navigation system of the present invention may cooperate with a magnetic resonance imager (MRI).

[0022] Other features and advantages of the present invention will be described below, and partly become obvious from the description, or be understood by implementing the present invention. The objectives and other advantages of the present invention will be implemented and achieved through the structures specifically indicated in the description, claims and drawings.

[0023] In order to make the above-mentioned objectives, features and advantages of the present invention more obvious, preferred embodiments are described in detail below in conjunction with the accompanying drawings.

[0024] Unless the context clearly requires otherwise, throughout the description and the claims, the words "comprise", "comprising", and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of "including, but not limited to".

BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the technical solutions of the specific embodiments of the present invention or the prior art, a brief introduction may be given hereinafter to the accompanying drawings that may be used in the description of the specific embodiments or the prior art. Obviously, the accompanying drawings in the description below are used for illustrating some embodiments of the present invention, and those of ordinary skill in the art may still derive other drawings from these accompanying drawings without creative efforts. The structures in the drawings are schematic and may not be true to scale.

[0026] FIG. 1 is a schematic diagram of the surgical navigation system according to a first aspect of the present invention;

[0027] FIG. 2 is a schematic diagram of a connection fixing device 100 in FIG. 1 according to an embodiment;

[0028] FIG. 3 shows an appearance of a position adjusting device 200 and a guiding device 400 in FIG. 1 according to an embodiment;

[0029] FIG. 4 is a diagram of an internal structure of the position adjusting device 200 and the guiding device 400 in FIG. 3;

[0030] FIG. 5 is a schematic diagram of the guiding device 400 contains a partial special structure according to an embodiment of the present invention;

[0031] FIG. 6 is a schematic diagram of the guiding device 400 contains a positioning marker according to an embodiment;

[0032] FIG. 7 is a schematic diagram of an example in which the base contains a positioning marker;

[0033] FIG. 8 is a schematic diagram of connectors each contains a positioning marker according to an embodiment;

[0034] FIG. 9 is a schematic diagram of an example according to a second aspect of the present invention;

[0035] FIG. 10 is a detailed schematic structural diagram of a tracking module B in FIG. 9;

[0036] FIG. 11 shows a schematic diagram of a positioning fitting 500-1 and a reference mark 500-2 according to an example;

[0037] FIG. 12 shows a schematic diagram of the positioning fitting 500-1 in a use state;

[0038] FIG. 13 shows a schematic diagram of a partial structure of the surgical navigation system in a use state according to an embodiment of the second aspect of the present invention;

[0039] FIG. 14 shows a schematic diagram of a positioning fitting 500-3 and a reference mark 500-4 according to an example;

[0040] FIG. 15 shows a schematic diagram of the positioning fitting 500-3 in a use state;

[0041] FIG. 16 shows a schematic diagram of a partial structure of the surgical navigation system in a use state according to yet another embodiment of the second aspect of the present invention; and

[0042] FIG. 17 shows a schematic diagram of a partial structure of the surgical navigation system in a use state according to a third aspect of the present invention.

[0043] Reference numerals

[0044] 000-fixture; 100-connection fixing device; 200-position adjusting device; 300-controlling module; 400-guiding device; 101-fastening structure, 102-supporting arm, 103-first joint, 104 first adjusting arm, 105-second joint, 106-second adjusting arm, 107-third joint, 108-connecting arm; 211-first plane, 212-second plane, 213-first motor, 214-second motor, 221-third plane, 222-fourth plane, 223-third motor, 224-fourth motor; 215-first connector, 225-second connector, 401-guiding catheter; B10-movable baseplate, B20-bracket, B30-light-emitting and image-capturing unit, B201-pillar, B202-first bracket joint, B203-connecting rod, B204-second bracket joint, B205-first adjusting rod, B206-third bracket joint, B207-second adjusting rod; C10-movable baseplate, C20-host, C30-input device, C40-display; 700-host, 800-input device, 900-display device; 500-1-positioning fitting, 500-3-positioning fitting, 500-5-positioning fitting, 500-2-reference mark, 500-4-reference mark, 601-positioning marker, 602-positioning marker,

603-positioning marker, 604-positioning marker, 605-positioning marker, and 606-positioning marker. DETAILED DESCRIPTION

[0045] In order to make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, but not all of them. Based on the embodiments of the present invention, all other embodiments derived by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0046] In order to facilitate an understanding of the embodiments, the surgical navigation system disclosed in an embodiment of the present invention is first introduced in detail.

[0047] Referring to FIG. 1, the surgical navigation system according to a first aspect of the present invention includes: a spatial positioning module, and a workstation. The spatial positioning module includes: a connection fixing device 100; a position adjusting device 200; a controlling module 300; and a guiding device 400. The workstation includes a host 700, an input device 800, a display device 900, and a communication interface.

[0048] FIG. 2 is a schematic diagram of the connection fixing device 100 of the spatial positioning module according to an embodiment. The connection fixing device 100 is configured to connect a fixture with the position adjusting device 200. The fixture 000 may be a wall, a stage, a ceiling, a hospital bed, or a head frame, etc., preferably a hospital bed, so as to keep the position adjusting device 200 relatively close and stable relative to a patient. A fastening structure 101 connects the fixture 000 with a supporting arm 102; and a first joint 103 connects the supporting arm 102 with a first adjusting arm 104, and preferably, the first joint 103 may be adjusted in various directions. A second joint 105 connects the first adjusting arm 104 with a second adjusting arm 106. A third joint 107 connects the second adjusting arm 106 with a connecting arm 108. The fastening structure 101 may be various clamping structures, such as spring clips. The supporting arm 102, the first adjusting arm 104, the second adjusting arm 106, and the connecting arm 108 are of long rigid structures, such as cylinders, cuboids, and the like.

[0049] Referring to FIGS. 3 and 4, which show schematic diagrams of the position adjusting device 200 and the guiding device 400 according to an embodiment. FIG. 3 shows a housing design 2001 of the position adjusting device 200, and FIG. 4 shows an internal structure of the position adjusting device 200. The position adjusting device 200 includes a base 201, a power structure, a first moving assembly, and a second moving assembly. The first moving assembly includes a first plane 211 and a second plane 212, and the power structures corresponding thereto are a first motor 213 and a second motor 214. The second moving assembly includes a third plane 221 and a fourth plane 222 (not shown here), and the power structures corresponding thereto are a third motor 223 and a fourth motor 224. The first motor 213 controls a movement of the first plane 211 via a kinematic pair, and the second motor 214 controls a movement of the second plane 212 via a kinematic pair; a direction of movement of the second plane 212 and a direction of movement of the first plane 211 are perpendicular to each other, thereby driving a first connector 215 connected to the first plane 211 to move in two dimensions. The third motor 223 controls a movement of the third plane 221 via a kinematic pair, and the four motor 224 controls a movement of the fourth plane 222 via a kinematic pair; a direction of movement of the fourth plane 222 and a direction of movement of the third plane 221 are perpendicular to each other, thereby driving a second connector 225 connected to the third plane 221 to move in two dimensions. Through the movement of the first connector 215 and the movement of the second connector 225, a controlled positioning of a guiding catheter 401 in a three-dimensional space is realized. The first, the second, the third, and the fourth here are not sequential, and are only for convenience of description, and may be used interchangeably in certain ranges without affecting the function of the position adjusting device 200.

[0050] The position adjusting device 200 and the guiding device 400 are preferably made of materials of suitable strength (for example, engineering plastics). In an embodiment, the motors (i.e., the first motor 213, the second motor 214, the third motor 223, and the fourth motor 224) are non-magnetic motors. The connection fixing device 100, other parts of the position adjusting device 200, and the guiding device 400 are made of materials compatible with magnetic resonance, such as engineering plastic and rubber, so that the spatial positioning module may be used under magnetic resonance conditions.

[0051] The controlling module 300 controls a movement of the position adjusting device 200, may be a separate module or integrated within other parts, controls a stepper motor via a wired or wireless connection, and in a specific example, controls the first motor 213, the second motor 214, the third motor 223, and the fourth motor 224. The controlling module 300 may exist independently, and controls the position adjusting device 200 via an effective communication connection, or may be integrated onto the position adjusting device 200. In another case, the controlling module may be integrated into the workstation.

[0052] Referring again to FIG. 4, in a specific example, the guiding catheter 401 of the guiding device 400 is made of a material that may be easily recognized and positioned in medical imaging (CT, MRI, or both CT and MRI), such as a non-magnetic alloy, a non-magnetic metal, and a carbon fiber, so that the guiding device can be medically imaged together with the patient, and thus a relative position of the guiding device relative to the patient medical is acquired. A movement path is designed by taking the relative position as a reference, so that the guiding catheter is adjusted to a desired position and direction.

[0053] Referring to FIG. 5, in another specific embodiment, parts 402 and 403 of the guiding catheter 401 are made of materials that may clearly show their contours and positions in the medical imaging. 402 and 403 are parts of the wall of the guiding catheter 401, and are two parallel arc-shaped structures with different lengths, so that a center position and direction of the through hole of the guiding catheter 401 can be calculated. Obviously, the structural design of this embodiment is only exemplary, and any structure, such as a cross structure, capable of determining the center position and direction of the through hole by calculation is included in the scope of the present invention.

[0054] In another embodiment, a medical assistant robot of the present invention contains a marker capable of displaying a position in medical imaging, and thus can position the guiding device 400 in the medical imaging. The positioning marker may be different dependent on the imaging method, and for example, may be a positioning marker made of a high-density material suitable for CT technology, a positioning marker suitable for MRI technology, or a titanium alloy marker that meet requirements of both CT and MRI.

[0055] In a specific embodiment, referring to FIG. 6, with respect to the medical assistant robot of the present invention, three positioning markers 601, 602 and 603 are embedded on the guiding catheter 401. The size and embedded positions of these markers are known, and the size of the guiding catheter 401 is known, and thus, in the medical imaging, an orientation and position of the guiding catheter 401 can be calculated based on the positions of the three positioning markers. The number of markers may be more than three. In another specific embodiment, the positioning markers 601, 602, and 603 are detachable and mounted before use via a connecting structure on the guiding catheter.

[0056] In another specific embodiment, with respect to the medical assistant robot of the present invention, positioning markers are mounted on the base 201 or on a fixed position relative to the base 201. Referring to FIG. 7, three positioning markers 601, 602, and 603 are shown. Since the mounting positions are known, a position of the base 201 can be determined by the positioning markers 601, 602, and 603 in the medical imaging, and an orientation and position of the guiding catheter 401 can be calculated based on a movement of the motor and the base 201 by the controlling module 300 or the host 700. In order to ensure that a movement distance calculated based on rotation of the motor is correct, a position feedback device is additionally provided in this embodiment to confirm that the movement distance recorded based on the rotation of the motor is completely correct. Obviously, the number of positioning markers may be more than three, the shape of the positioning markers may be other shapes whose geometric center can be calculated, and the positioning markers 601, 602, and 603 may also be detachable.

[0057] In yet another specific embodiment, with respect to the medical assistant robot of the present invention, positioning markers are mounted on a connector or on a plane having a fixed positional relationship with the connector. Referring to FIG. 8, two sets of positioning markers are included according to an embodiment. A spatial position of a first connector 215 may be determined based on the first set of positioning markers 601, 602, and 603, and a spatial position of a second connector 225 may be determined based on the second set of positioning markers 604, 605, and 606, so that an orientation and position of the guiding catheter 401 can be calculated. The number of positioning markers in each set of positioning markers may be more than three, the shape of the positioning markers may be other shapes whose geometric center can be calculated, and the positioning markers 601, 602, and 603 may also be detachable.

[0058] The surgical navigation system according to a second aspect of the present invention includes: a spatial positioning module, a tracking module, and a workstation, wherein the tracking module or a part thereof may be integrated within the workstation.

[0059] In an embodiment, the spatial positioning module includes: a connection fixing device, a position adjusting device, a controlling module, and a guiding device. The tracking module includes: an image-capturing device, a positioning fitting, and a reference mark. The workstation includes: a host, an input device, a display device, and a communication interface.

[0060] In another embodiment, the spatial positioning module includes: a connection fixing device, a position adjusting device, a controlling module, and a guiding device. The tracking module includes: a light-emitting component, an image-capturing device, a positioning fitting, and a reference mark. The workstation includes: a host, an input device, a display device, and a communication interface.

[0061] FIG. 9 shows an example according to the second aspect. The spatial positioning module includes a connection fixing device 100, a position adjusting device 200, and a guiding device 400. A structure of the connection fixing device 100 is shown. The supporting arm 102 is conical; the first joint 103 may realize the rotation of the first adjusting arm 104 relative to the supporting arm 102. The second joint 105 may realize the rotation of the second adjusting arm 106 relative to the first adjusting arm 104, and may realize angle locking. The third joint 107 may realize the rotation of the second adjusting arm 106 relative to the connecting arm 108. The fastening structure 101 is not shown. The tracking module B includes: a movable baseplate B1, a bracket B20, a light-emitting unit and image-capturing unit B30, a positioning fitting 500-1 and a reference mark 500-2 (see FIG. 11, not shown in FIG. 9). The movable baseplate B10 is equipped with at least three wheels to be moved freely. In a preferred embodiment, the movable baseplate B10 is equipped with four wheels and contains a stop structure. After the movable baseplate B10 is moved to a desired position, the position of the movable baseplate B10 may be prevented by the stop structure from being changed during the surgical procedure. See FIG. 10, the bracket B20 consists of a pillar B201, a first bracket joint B202, a connecting rod B203, a second bracket joint B204, a first adjusting rod B205, a third bracket joint B206, and a second adjusting rod B207. The position of the light-emitting and image-capturing unit B30 may be adjusted by the bracket B20, so that a target area is within an optimum operating range of the light-emitting and image-capturing unit B30. The workstation C includes: a workstation movable baseplate C1O, a host C20, an input device C30, and a display C40. The workstation movable baseplate C10 is equipped with four wheels and a stop structure, and thus may be moved. After reaching a desired position, the workstation movable baseplate C10 is fixed by the stop structure to prevent its position from being changed during the surgical procedure. The host C20 contains a processor and a communication interface. The processor contains pre-loaded software, and thus may process data, plan a path, receive data via the communication interface, send an instruction to the spatial positioning module, virtually fuse a surgical tool matched with the spatial positioning module into a three-dimensional image imaged by the software, and display it to a user through the display C40. The input device C30 is a keyboard, a mouse, or a voice input device. The display C40 is a touch screen. That is, in the case that the display C40 has both input and output functions, the input device C30 may be omitted.

[0062] The controlling module 300 is integrated within the host C20 and is not shown. In another example, the controlling module 300 only exists as an independent module.

[0063] The positioning fitting is of a rigid structure equipped with several optically traceable markers, wherein the optical positioning markers are arranged in a unique spatial distribution. Thus, a unique coordinate system can be determined. The optically traceable markers include but are not limited to active luminescent markers and light-reflecting markers, patterns containing corner points, etc.

[0064] FIG. 11 shows a specific example of the positioning fitting and the reference mark. The positioning fitting 500-1 cooperates with the reference mark 500-2. The positioning fitting 500-1 is equipped with four spherical optical positioning markers (a first spherical optical positioning marker 511, a second spherical optical positioning marker 512, a third spherical optical positioning marker 513, and a fourth spherical optical positioning marker 514). The reference mark 500-2 is equipped with four spherical optical positioning markers (a first spherical optical positioning marker 521, a second spherical optical positioning marker 522, a third spherical optical positioning marker 523, and a fourth spherical optical positioning marker 524). After being reflected by the spherical optical positioning markers, the light emitted by the light-emitting component is received by the image-capturing unit; and then a spatial position of the guiding catheter 401 and a spatial position of the through hole of the guiding catheter 401 are determined by calculation.

[0065] Referring to FIG. 12 for a use state, a taper portion 502 of the positioning fitting 500-1 is inserted into the through hole of the guiding catheter 401, a position of the guiding catheter 401 is calibrated by the positioning fitting 500-1, and the position of the guiding catheter is displayed on the display. Based on the preoperative planning, the guiding catheter 401 is adjusted to a desired position, and then a surgical instrument such as an electric drill, a guide wire, an electrode, may be guided to pass through the through hole of the guiding catheter 401 to perform a surgical procedure.

[0066] Referring to FIG. 13, which describes a use plan according to an embodiment of the second aspect. Based on the patient's preoperative CT and MRI data, the workstation generates or receives a three-dimensional image, and the reference mark 500-2 is fixedly connected to the patient's site to be operated, for example, is connected to the head by a rigid structure, so that the relative position of the reference mark 500-2 with respect to the patient's site to be operated remains unchanged during the surgical procedure. By taking the reference mark 500-2 as a reference criterion, the positioning fitting 500-1 is used for calibration by anatomical characteristic points or by characteristic structural points that are visible in the image and in the anatomy, a corresponding relationship between the established three-dimensional image and the site to be operated is acquired. Then, the positioning fitting 500-1 is inserted into the guiding device 400, and the movement of the spatial positioning module is controlled by the optical tracking module and the software, so that the guiding device 400 reaches a desired position.

[0067] FIG. 14 shows the positioning fitting and the reference mark according to another specific example. The positioning fitting 500-3 cooperates with the reference mark 500-4. The positioning fitting 500-3 is equipped with four optical positioning markers (a first corner point optical positioning marker 531, a second corner point optical positioning marker 532, a third corner point optical positioning marker 533, and a fourth corner point optical positioning marker 534). The reference mark 500-4 is equipped with four optical positioning markers (a first corner point optical positioning marker 541, a second corner point optical positioning marker 542, a third corner point optical positioning marker 543, and a fourth corner point optical positioning marker 544). The image-capturing unit directly acquires image information of the positioning fitting and the reference mark, and then a spatial position of the guiding catheter 401 and a spatial position of the through hole of the guiding catheter 401 are determined by calculation.

[0068] Referring to FIG. 15 for a use state, a taper portion 502 of the positioning fitting 500-3 is inserted into the through hole of the guiding catheter 401. By taking the reference mark 500-4 as a reference, a position of the guiding catheter 401 is calibrated by the positioning fitting 500-3, and the position of the guiding catheter 401 is displayed on a matched display. Based on the preoperative planning, the guiding catheter 401 is adjusted to a desired position, and then a surgical instrument such as an electric drill, a guide wire, an electrode, may be guided to pass through the through hole of the guiding catheter 401 to perform a surgical procedure.

[0069] Referring to FIG. 16, which describes a use plan of an embodiment according to the second aspect. Based on the patient's preoperative CT and MRI data, the workstation generates or receives a three-dimensional image, and the reference mark 500-4 is fixedly connected to the patient's site to be operated, for example, is connected to the head by a rigid structure, so that the relative position of the reference mark 500-4 with respect to the patient's site to be operated remains unchanged during the surgical procedure. By taking the reference mark 500-4 as a reference, the positioning fitting 500-3 is used for calibration by anatomical characteristic points or by characteristic structural points that are visible in the image and in the anatomy, a corresponding relationship between the established three-dimensional image and the site to be operated is acquired. Then, the positioning fitting 500-3 is inserted into the guiding device 400, and the movement of the spatial positioning module is controlled by the optical tracking module and the software, so that the guiding device 400 reaches a desired position.

[0070] Referring to FIG. 17, an embodiment of the surgical navigation system according to a third aspect of the present invention includes: a spatial positioning module, a tracking module, a workstation, and an ultrasound module. The spatial positioning module and the workstation are as described according to the first aspect. The tracking module includes an image-capturing device, positioning fittings 500-3 and 500-5, and a reference mark 500-4. The ultrasound module includes a conventional ultrasound apparatus. The positioning fitting 500-5 is connected to an ultrasound probe of the ultrasound apparatus, and the position of the ultrasound probe in the coordinate system of the optical tracking module by taking the reference mark 500-4 as a reference may be determined by the positioning fitting 500-5. By a relative position relationship between the positioning fitting 500-5 and the ultrasound probe, the ultrasound image is subjected to a coordinate system transformation into a coordinate system taking the reference mark 500-4 as a reference. At the same time, the position of the positioning fitting 500-3 of the spatial positioning module is acquired. The positioning fitting 500-3 is displayed in the coordinate system of the image by virtue of the relative position relationship with respect to the reference mark 500-4, so as to obtain the positional relationship of the guiding device 400 in the ultrasound image. The ultrasound module may be an existing ultrasound apparatus, that is, an adapted positioning fitting 500-5 may be mounted onto the ultrasound probe. The positioning fitting 500-5 may be fixedly mounted or detachable.

[0071] Another embodiment of the surgical navigation system according to the third aspect of the present invention includes a spatial positioning module, a tracking module, a workstation, and an ultrasound module. The spatial positioning module and the workstation are as described according to the first aspect. The tracking module is an electromagnetic tracking module, and includes a magnetic field generating device and a reference mark. The reference mark contains a magnetic positioning marker. The spatial positioning module is connected to the magnetic positioning marker. The ultrasonic module is connected to the magnetic positioning marker. When in use, the magnetic field generating device is close to a site to be detected and generates an electromagnetic field (a first signal), and the magnetic positioning marker generates a second signal in response to the first signal, so that by taking the reference marker as a reference, a relative position relationship of the spatial positioning module and the ultrasonic module with respect to the reference marker can be established in the same coordinate system. Then, based on a spatial position relationship of the magnetic positioning marker with respect to the ultrasound probe, a coordinate system of the ultrasound image and a coordinate system of the electromagnetic tracking module are unified to realize the positioning of the guiding device 400 in the ultrasound image. The reference mark may preferably be attached to the skin of the site to be operated. When the site to be operated changes with breathing, the imaging may be adjusted based on the reference mark to avoid the influence on the positioning.

[0072] In the description of the embodiments of the present invention, unless otherwise explicitly defined or limited, the terms "mounted", "connected with", and "connected to" should be interpreted broadly. For example, they may refer to a fixed connection, detachable connection or integrated connection, or may be a mechanical connection or electrical connection, or may refer to a direct connection or an indirect connection via an intermediary, or may be an internal communication of two elements. For those of ordinary skill in the art, the specific meanings of the above-mentioned terms in the present invention may be understood according to specific situations.

[0073] Finally, it should be noted that the above-mentioned embodiments are only specific implementations of the present invention, which are used to illustrate the technical solutions of the present invention and shall not be construed as limitation. The protection scope of the present invention is not limited thereto. Although referring to the foregoing embodiments to make a detailed description for the present invention, those of ordinary skill in the art should understand that: for any person skilled in the art, modifications may still be made to the technical solutions described in the foregoing embodiments within the technical scope disclosed in the present invention, or changes may be easily conceived, or equivalent substitutions may be made for some of the technical features; these modifications, changes or substitutions do not deviate the nature of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention, and should fall within the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims

CLAIMS What is claimed is: 1. A surgical navigation system, comprising: a workstation, wherein the workstation comprises a communication interface, a processor, a display device, and an input device, and wherein the communication interface is configured for communication connection, the processor contains pre-loaded software, the display device is configured to display an interface of the software, and the input device is configured to input a command from a user; and a spatial positioning module, comprising: a connection fixing device configured to fix a structure connected to a distal end of the connection fixing device; a position adjusting device comprising a base, a power structure, and at least two sets of moving assemblies, wherein each set of moving assemblies contains two components capable of moving relatively, and the power structure is capable of prompting the two components to move relative to each other; a controlling device configured to regulate the power structure and perform communication connection; a guiding device containing a through hole, configured to guide a surgical instrument; and a position feedback device configured to calibrate a distance change caused by the power structure; and wherein, the position adjusting device is connected to the distal end of the connection fixing device, and the guiding device is hinged to the two sets of moving assemblies of the position adjusting device via a first connector and a second connector, respectively, the two sets of moving assemblies driving the first connector and the second connector to move in two dimensions relative to the base, and the position feedback device calibrating the distance change caused by the power structure, so that the guiding device connected with the first connector and the second connector reaches a desired position based on movements of the two sets of moving assemblies, and a position of a part of the spatial positioning module is detectable in medical imaging, thereby positioning the through hole of the guiding device in a three-dimensional space.
2. The surgical navigation system according to claim 1, wherein the part of the spatial positioning module is the guiding device or a part of the guiding device.
3. The surgical navigation system according to claim 1, wherein the spatial positioning module further comprises a positioning marker, and the positioning marker is a marker whose position is detectable in medical imaging; and/or, the positioning marker is a marker whose position is detectable by a tracking module.
4. The surgical navigation system according to claim 3, wherein the medical imaging is magnetic resonance imaging (MRI), X-ray computed tomography (CT), or X-ray imaging.
5. The surgical navigation system according to claim 3, wherein the surgical navigation system further comprises the tracking module configured to track and determine a spatial position of the spatial positioning module.
6. The surgical navigation system according to claim 5, wherein the tracking module comprises an image-capturing unit; and/or, the tracking module comprises an image-capturing and light-emitting unit; and/or, the tracking module comprises an electromagnetic tracking unit.
7. The surgical navigation system according to claim 5 or 6, wherein the tracking module further comprises a reference mark capable of being fixedly connected to a target site.
8. The surgical navigation system according to claim 1, further comprising a tracking module and an ultrasound module.
9. The surgical navigation system according to claim 8, wherein the tracking module is an optical tracking module, the ultrasound module contains an optical positioning marker, the spatial positioning module contains an optical positioning marker, and the optical tracking module comprises a reference mark and is capable of simultaneously tracking the ultrasound module and the spatial positioning module.
10. The surgical navigation system according to claim 9, wherein the tracking module is an electromagnetic tracking module, the ultrasonic module contains a magnetic positioning marker, the spatial positioning module contains a magnetic positioning marker, the electromagnetic tracking module contains a magnetic field generating device and a reference mark, and the electromagnetic tracking module is capable of simultaneously tracking positions of the spatial positioning module and the ultrasound module.
11. The surgical navigation system according to claim 10, wherein the reference mark is closely connected to skin near a site to be detected when in use, and the electromagnetic tracking module tracks a change in the position of the reference mark for calibration to eliminate a tracking error caused by tissue displacement.