CN120241219B

CN120241219B - System for spinal fixation

Info

Publication number: CN120241219B
Application number: CN202510748333.0A
Authority: CN
Inventors: 常涛; 辛晨; 刘俊; 袁方; 吴文娟
Original assignee: I Join Medical Technology Co ltd
Current assignee: I Join Medical Technology Co ltd
Priority date: 2025-06-06
Filing date: 2025-06-06
Publication date: 2025-09-02
Anticipated expiration: 2045-06-06
Also published as: CN120241219A

Abstract

The present invention relates to a system for spinal fixation. The system includes a processing module and a measurement assembly including a tissue detection device and an angle measurement device. The tissue detection device includes a probe for insertion along a tract of a target vertebra of a patient to be stapled and for obtaining tissue information in the tract. The processing module is configured to receive, in real-time, tissue information measured by the probe during insertion into a target vertebra of a patient along a current lane, and to determine, based on the received tissue information, a tissue type in the current lane in real-time to determine whether the current lane is a safe lane. The angle measurement device is configured to measure an angle of each of the plurality of safety lanes for determining a spatial relationship between the plurality of safety lanes. The invention can allow a plurality of safety nail paths to be reasonably distributed so as to reduce the damage to the structure of the target vertebrae, reduce the installation difficulty of the connecting rod and optimize the correction force of the connecting rod installed between the target vertebrae.

Description

System for spinal fixation

Technical Field

The present invention relates to the field of medical devices, and more particularly to an auxiliary system for use in spinal fixation surgery.

Background

Key points for spinal endoprosthesis procedures include accurately locating the pedicle screw insertion point and the pedicle screw implantation angle (e.g., sagittal and horizontal angles of the tract), determining a safe pedicle screw tract, determining a suitable screw insertion depth, etc. In the prior art of internal fixation of the spine, doctors often judge the screw feeding point and the implantation angle of the pedicle screw through experience. However, in the case of patient anatomy variations, lack of anatomical landmarks or local structural complications, etc., empirically implanting pedicle screws will result in increased fixation errors. It is reported in the literature that about 20% of pedicle screws in conventional implantation methods are used to puncture the pedicle wall, resulting in nerve root, spinal cord, vascular injury. In addition, a decrease in mechanical stability due to structural destruction of the pedicle may occur, eventually leading to loosening of the pedicle screw.

At present, a computer navigation system is proposed to be applied to spinal surgery to assist in the implantation of pedicle screws. In the operation process, the computer technology is utilized to unify the image data of the patient before or during the operation, the body position of the patient in the actual operation process and the coordinates of the operation tool, and the corresponding display is made to the tissues around the operation tool according to the actual operation requirement, so as to navigate the operation in real time. However, although navigation techniques may improve the accuracy and safety of pedicle screw implantation, navigation techniques have disadvantages in that (1) the patient's position during the pre-operative CT scan of the patient may be different from the patient's position during the operation, which may cause a change in the positional relationship of adjacent vertebrae of the spine, which is more apparent in patients with unstable spines, (2) in order to track the patient's shift or bone structure change caused by any reason during the navigation, a tracer is often required to be implanted, for example, to be fixed near the operative bone structure of the patient, such as the spinous process or the iliac spine, however, the fixation of the tracer is an invasive manner, which increases the risk of damaging the bone mass, damaging the vital vascular nerves or causing infection, (3) the registration process of the navigation system is cumbersome and the registration point of the "idealized" is judged to have difficulty, which may result in a significant extension of the implantation time of the pedicle screw, (4) the equipment used in navigation techniques is huge, expensive and complex to operate, which presents a considerable challenge to the popularization of navigation techniques.

In addition, also proposed a nail way setting up device with real-time supervision function, it utilizes the characteristics that different biological tissues have different resistance, detects inter-electrode resistance through resistance measurement part, and medical personnel adjusts nail way direction according to resistance size to can guarantee the accurate establishment of nail way, avoid pedicle of vertebral arch nail misplacement, reduce and produce extra damage to the patient, improve operation security, and save operation time. However, the nail path establishment apparatus can only perform safety precaution on the nail path when determining the nail path, so that problems possibly occurring when connecting rods are installed between pedicle nails in the follow-up process, for example, the connecting rods are difficult to install, and the direction and the size of correction force of the installed connecting rods are changed, thereby affecting the correction effect of the spine, etc., and the nail path establishment apparatus cannot solve the problems.

In view of the foregoing, there is a need for improvements in existing auxiliary devices or systems for intraspinal fixation to simplify the intraoperative manipulation of intraspinal fixation and/or to enhance the postoperative effect.

Disclosure of Invention

The present invention is directed to solving one or more of the above-mentioned problems with existing auxiliary devices or systems for intraspinal fixation.

In one aspect of the invention, a system for spinal fixation is provided, the system comprising a measurement assembly including a tissue detection device including a measurement probe for insertion along a tract of a target vertebra of a patient to be stapled and obtaining tissue information in the tract, and an angle measurement device configured to be detachably connected to the tissue detection device, a processing module communicatively coupled to the measurement assembly and configured for receiving in real time tissue information obtained by the probe during insertion along a current tract of the target vertebra of the patient, and determining in real time a tissue type in the current tract based on the received tissue information to determine whether the current tract is a safety tract, wherein the angle measurement device is configured for measuring an angle of each of a plurality of safety tunnels for determining a spatial relationship between the plurality of safety tunnels.

In at least one embodiment of an aspect of the invention, the spatial relationship between the plurality of safety lanes includes parallelism between the plurality of safety lanes located on different target vertebrae and symmetry between the plurality of safety lanes located on the same target vertebrae, the plurality of safety lanes being determined as available lanes when at least one of parallelism between the plurality of safety lanes located on different target vertebrae meets the parallelism requirement and symmetry between the plurality of safety lanes located on the same target vertebrae meets the symmetry requirement.

In at least one embodiment of one aspect of the invention, the measurement assembly further includes a first handle having a first connection for connecting the probe to the first handle and a second connection for connecting the angle measurement device to the first handle and a third connection for mating with the second connection of the first handle to rotatably connect the second handle and the first handle together.

In at least one embodiment of one aspect of the invention, the measurement assembly further comprises a connector having a first end for electrical connection with the probe and a second end for electrical connection with an external circuit, wherein the connector has a spring structure at the first end configured such that the first end of the connector remains in electrical connection with the probe at all times when the probe is operated to rotate.

In at least one embodiment of one aspect of the invention, the system further comprises an open-circuit drill having one end for connection to a power source and the other end having a drill bit for drilling a pit in a target vertebra of the patient, the pit being used as a staple feeding point for a staple channel.

In at least one embodiment of one aspect of the invention, the system further comprises a spike point positioning device comprising a sleeve having a channel therein for receiving the open-path drill, a transverse bar having graduations thereon, a longitudinal bar having graduations thereon and having one end fixedly connected to the sleeve, and a slider having a first channel for receiving the transverse bar and allowing the slider to move along the transverse bar and a second channel for receiving the longitudinal bar and allowing the slider to move along the longitudinal bar.

In at least one embodiment of one aspect of the invention, the transverse rod has a locating portion at the 0 scale for securing to the inferior surface of the spinous process of the targeted vertebra, and one end of the longitudinal rod near the 0 scale is fixedly connected to the sleeve.

In at least one embodiment of one aspect of the invention, the system further includes a display module for communicatively coupling with the measurement assembly and the processing module and configured to receive in real time the tissue type in the respective lane determined by the processing module, display in real time the received tissue type in the current lane, receive in real time the angle of each of the plurality of safety lanes measured by the angle measurement device, and display in real time the plurality of safety lanes for viewing by an operator based on the received angle of each of the plurality of safety lanes to determine the spatial relationship between the plurality of safety lanes.

In at least one embodiment of one aspect of the invention, the angle includes a horizontal plane angle and a sagittal plane angle, and the display module is further configured to display the plurality of safety lanes on a cross-sectional image of the patient's spine based on the horizontal plane angle of each of the plurality of safety lanes and to display the plurality of safety lanes on a lateral slice image of the patient's spine based on the sagittal plane angle of each of the plurality of safety lanes.

In at least one embodiment of one aspect of the invention, the system further comprises a visualization module comprising one or more calibration surfaces, each calibration surface having therein a pattern of known geometry, the pattern being filled with a visualization material, the visualization module being for mounting in proximity to a target vertebra of the patient for facilitating acquisition of a medical image comprising the visualization module and the target vertebra using a medical imaging device.

In at least one embodiment of one aspect of the invention, the system further comprises a camera for capturing the medical image including the visualization module and the target vertebra to obtain a camera image, the processing module is further configured to receive the camera image from the camera, determine whether the camera image is distorted based on a pattern in a calibration surface of the visualization module in the camera image, and adjust the camera image to eliminate the distortion when the camera image is determined to be distorted, the display module is further configured to receive the adjusted camera image from the processing module, and display the adjusted camera image.

In at least one embodiment of one aspect of the invention, the visualization module includes a first calibration surface and a second calibration surface, the first calibration surface being perpendicular to the second calibration surface, the medical imaging device is configured to acquire a side-lobe medical image including the first calibration surface of the visualization module and the target vertebra, and the medical imaging device is configured to acquire a side-lobe medical image including the second calibration surface of the visualization module and the target vertebra, the camera is configured to capture the side-lobe medical image to obtain a side-lobe camera image, and the camera is configured to capture the side-lobe medical image to obtain a side-lobe camera image, the processing module is further configured to receive the side-lobe camera image and the side-lobe camera image from the camera, determine whether the side-lobe camera image is distorted based on a pattern in the first calibration surface of the visualization module in the side-lobe camera image, determine whether the side-lobe camera image is distorted based on a pattern in the second calibration surface of the visualization module in the side-lobe camera image, and determine whether the side-lobe camera image is distorted and/or the respective camera image is distorted.

In at least one embodiment of one aspect of the invention, the system further comprises a user input device for receiving a pedicle screw model of a user input, the display module is for communicatingly coupling with the user input device and is further configured for displaying a cross-sectional image including the target vertebra, the cross-sectional image including a cross-sectional medical image or a cross-sectional camera image, the cross-sectional camera image being obtained with the medical imaging device, the cross-sectional camera image being a undistorted camera image or an adjusted camera image, displaying a side-piece image including the target vertebra, the side-piece image including a side-piece medical image or a side-piece camera image, the side-piece camera image being a undistorted camera image or an adjusted camera image, receiving the pedicle screw model from the user input device, displaying the pedicle screw model superimposed on the side-piece image including the target vertebra and displaying the pedicle screw model superimposed on the cross-sectional image including the target vertebra.

In at least one embodiment of one aspect of the present invention, the user input device is configured to further receive a user input of a horizontal plane angle and a sagittal plane angle of a planned tract, the display module is further configured to receive the horizontal plane angle and the sagittal plane angle of the planned tract from the user input device, to superimpose the planned tract on a cross-sectional image including the target vertebra based on the horizontal plane angle of the planned tract, and to superimpose the planned tract on a lateral plate image including the target vertebra based on the sagittal plane angle of the planned tract.

In at least one embodiment of one aspect of the invention, the system further comprises a guide comprising a cannula having a channel therein for receiving a channel-expanding member for insertion into the target vertebra to form a tack in the target vertebra, and a mounting portion connected to the cannula and for mounting the angle measuring device thereto, the angle measuring device mounted to the mounting portion for measuring a level angle and a sagittal plane angle of a tack to be formed during insertion of the channel-expanding member into the target vertebra to form a tack, the display module being further configured for receiving the level angle and the sagittal plane angle of the tack to be formed from the angle measuring device, further superimposing the tack to be formed on a cross-sectional image including the target vertebra superimposed with the tack based on the received level angle of the tack to be formed, and further superimposing the planned image including the planned image of the tack to be formed on the planned side superimposed with the planned image based on the received sagittal plane angle of the tack to be formed.

In at least one embodiment of one aspect of the invention, the current tract includes the planned tract, the probe is configured to measure tissue information in the planned tract during insertion of the target vertebra along the planned tract, and the angle measurement device is configured to measure an angle during insertion of the probe into the target vertebra to determine whether the probe is to be inserted into the target vertebra along the planned tract.

In at least one embodiment of one aspect of the invention, the system further comprises a vertebra positioning device comprising a vertebra fixation portion for securing the vertebra positioning device to a vertebra adjacent to a target vertebra of the patient, and a placement portion connected to the vertebra fixation portion and for mounting the visualization module thereto.

In at least one embodiment of one aspect of the present invention, the system further comprises a bedside positioning device comprising a bed frame fixing portion for fixing the bedside positioning device to a bed frame, a vertical positioning arm connected to the bed frame fixing portion, a horizontal positioning arm connected to the vertical positioning arm, and a fitting portion connected to the horizontal positioning arm and for mounting the developing module thereon.

The technical proposal provided by the invention can have at least one of the following advantages:

(1) By utilizing the measuring assembly integrating the tissue detection function and the angle measurement function, the angle of the nail channel can be measured while identifying the tissue type to ensure the safety of the nail channel, so that the spatial relationship among a plurality of safety nail channels can be determined, the distribution of the safety nail channels is improved, the reasonable distribution of the safety nail channels can reduce the damage to the structure of the target vertebrae, reduce the installation difficulty of the connecting rod and optimize the correction force of the connecting rod installed between the target vertebrae;

(2) Through the cooperation of the display module and the angle measuring device, an operator can be allowed to accurately implant pedicle screws along a planned nail path or a safe nail path in an operation, so that the implantation accuracy of the pedicle screws is effectively improved;

(3) By utilizing the visualization module, the degree of distortion of the camera image including the targeted vertebra can be significantly reduced to allow the camera image to be used in place of the medical image in spinal surgery, thereby accomplishing the surgery at low cost and with high convenience without reducing the precision of the surgery.

Drawings

To further clarify the above and other advantages and features of embodiments of the present invention, a more particular description of embodiments of the invention will be rendered by reference to the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope.

Fig. 1 shows a schematic view of a system for spinal fixation according to an embodiment of the invention.

Fig. 2 shows a schematic structural diagram of a measuring assembly according to an embodiment of the invention.

Fig. 3 shows a schematic view of a part of the construction of a measuring assembly according to an embodiment of the invention.

Fig. 4 shows a schematic structural view of an open-circuit drill according to an embodiment of the present invention.

Fig. 5 shows a schematic structural view of the nail feeding point positioning device according to the embodiment of the present invention.

Fig. 6 shows a schematic representation of an orthographic view of a spine of a patient according to an embodiment of the present invention.

FIG. 7 illustrates a lane planning process according to an embodiment of the present invention.

Fig. 8 shows a schematic structural view of a vertebral positioning device according to an embodiment of the present invention.

Fig. 9 shows a schematic structural view of a bedside positioning device according to an embodiment of the invention.

Fig. 10 illustrates a first display interface of a display module according to an embodiment of the present invention.

Fig. 11 illustrates a second display interface of a display module according to an embodiment of the present invention.

Fig. 12 illustrates a third display interface of a display module according to an embodiment of the present invention.

Fig. 13 shows a schematic structural view of a guide device according to an embodiment of the present invention.

Fig. 14 shows a fourth display interface of a display module according to an embodiment of the invention.

Fig. 15 illustrates a fifth display interface of a display module according to an embodiment of the present invention.

Detailed Description

The present invention will be further described in conjunction with the following specific embodiments and the accompanying drawings, in which further details are set forth in order to provide a thorough understanding of the present invention, but it will be apparent that the present invention can be practiced in many other ways than those described herein, and that those skilled in the art may make a similar promotion or deduction depending upon practical circumstances without departing from the spirit of the present invention, and therefore, the scope of the present invention should not be limited in its context to such specific embodiments.

The application uses specific words to describe embodiments of the application. Reference to "one embodiment," "other embodiments," and/or "some embodiments" means that a particular feature, structure, or characteristic is associated with at least one embodiment of the application. Thus, it should be emphasized and should be appreciated that two or more references to "one embodiment" or "other embodiments" or "some embodiments" in various positions in this specification are not necessarily referring to the same embodiment. Furthermore, certain features, structures, or characteristics of one or more embodiments of the application may be combined as suitable.

It should be noted that in order to simplify the presentation of the present disclosure and thereby aid in understanding one or more embodiments, the present disclosure may sometimes incorporate features from the description of embodiments of the present application into one embodiment, the drawings, or the description thereof. This method of disclosure does not imply that the subject application requires more features than are set forth in the claims.

In the description of the present disclosure, it should be noted that the terms "clockwise", "counterclockwise", "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like indicate an azimuth or a positional relationship based on that shown in the drawings, only for convenience of description and simplification of the description, and do not indicate or imply that the apparatus or element to be referred to must have a specific azimuth, be configured and operated in a specific azimuth, and thus should not be construed as limiting the present disclosure. In this disclosure, the end proximal to the operator (e.g., clinician) is defined as the posterior end, and the end proximal to the surgical patient is defined as the anterior end, the anterior end.

Referring to fig. 1, fig. 1 shows a schematic view of a system 1 for spinal fixation according to an embodiment of the invention.

As shown in fig. 1, a system 1 for spinal fixation may include a measurement assembly 10 and a processing module 20. The measurement assembly 10 may include a tissue detection device 11 and an angle measurement device 13. The tissue detection device 11 may include a probe 111 (see fig. 2), and the probe 111 may be used to insert a target vertebra of a patient along a tract to be stapled and to obtain tissue information in the tract. In some embodiments, the tissue information acquired by probe 111 may include one or more of tissue impedance, light information associated with the tissue (e.g., light reflectivity of the tissue), force information associated with the tissue (e.g., resistance to entry into the tissue), and the like.

The angle measuring device 13 may be used to measure the angle of the nail path, e.g. the horizontal plane angle and the sagittal plane angle. The horizontal plane angle may include an angle that is observable when the tract is projected onto a cross-sectional image of the patient's spine, and the sagittal plane angle may include an angle that is observable when the tract is projected onto a lateral slice image of the patient's spine. In some embodiments, the angle measurement device 13 may include an inertial sensor.

The processing module 20 may be communicatively coupled with the measurement assembly 10 to receive tissue information acquired from the tissue detection device 11 in real-time, e.g., tissue information acquired by the probe 111 during insertion into a target vertebra of a patient along a tract, such as tissue impedance, light information associated with tissue (e.g., light reflectivity of tissue), force information associated with tissue (e.g., resistance to access to tissue), and the like. The processing module 20 may determine the type of tissue in the lane in real time based on the received tissue information to determine whether the lane is a safe lane. For example, when the tissue type in the tract includes cortical bone, the processing module 20 may determine that the tract is unsafe. When the tissue type of the entire lane is cancellous bone, the processing module 20 may determine that the lane is safe. The processing module 20 may also receive the angle from each of the plurality of lanes measured by the angle measurement device 13 and determine a spatial relationship between the plurality of lanes based on the received angle of each of the plurality of lanes. The spatial relationship between the plurality of lanes may include parallelism between the plurality of lanes respectively located on different vertebrae, symmetry between the plurality of lanes located on the same vertebrae, and the like. In some embodiments, when parallelism between a plurality of safety lanes respectively located on different vertebrae meets the parallelism requirement, those safety lanes meeting the parallelism requirement may be determined as available lanes. In other embodiments, when symmetry between multiple lanes located on the same vertebra meets the symmetry requirement, those safe lanes that meet the symmetry requirement may be determined as available lanes. In still other embodiments, a safe lane that meets both the parallelism requirement and the symmetry requirement may be determined to be a usable lane when the parallelism between multiple safe lanes respectively located on different vertebrae meets the parallelism requirement and the symmetry between multiple lanes located on the same vertebrae meets the symmetry requirement.

In general, each of one or more targeted vertebrae to be stapled may have one usable lane or two usable lanes (which may be located on the left and right sides of the targeted vertebrae, respectively). In spinal fixation surgery, an operator (e.g., a clinician) may implant pedicle screws along available screw channels into a target vertebra of a patient, and then install connecting rods between the pedicle screws implanted into the target vertebra. The implantation of the connecting rods can help stabilize the patient's spinal structure, correct spinal deformities, protect nerves and spinal cord within the spine, and the like.

By utilizing the measurement assembly 10 integrating the tissue detection function and the angle measurement function, the present application can measure the angle of the safety lanes while identifying the tissue type to ensure lane safety, so that the spatial relationship between the plurality of safety lanes can be determined to improve the distribution of the plurality of safety lanes. The reasonable distribution of the safety nail channels can reduce the installation difficulty of the connecting rod and optimize the correction force of the connecting rod installed between the target vertebrae. In addition, when two pedicle screws are to be implanted into one target vertebra, the reasonable distribution of the screw paths of the two pedicle screws in space (for example, the screw paths of the two pedicle screws meet the symmetry requirement) can reduce the damage of the implanted pedicle screws to the target vertebra structure, and further can improve the stability of the pedicle screw implantation.

Referring to fig. 1, the system 1 may further include a display module 30. The display module 30 may be communicatively coupled to the measurement assembly 10 to receive the measured angle of the staple line from the angle measurement device 13 in real time. The display module 30 may display the lane in real time based on the angle of the received lane. As previously mentioned, the angle of the tack tract may include a horizontal plane angle and a sagittal plane angle. The display module 30 may display the tract on a cross-sectional image of the patient's spine based on the horizontal plane angle of the tract. The display module 30 may display the tract on a lateral slice image of the patient's spine based on the sagittal plane angle of the tract. The display module 30 may display a plurality of lanes simultaneously. For example, the display module 30 may display a plurality of lanes on a cross-sectional image of the patient's spine based on the horizontal plane angle of each of the plurality of lanes. The display module 30 may display the plurality of lanes on a lateral slice image of the patient's spine based on the sagittal plane angle of each of the plurality of lanes. The plurality of lanes are displayed for viewing by an operator to facilitate the operator in determining the spatial relationship between the plurality of lanes. The spatial relationship between the plurality of lanes may include parallelism between the plurality of lanes respectively located on different vertebrae, symmetry between the plurality of lanes located on the same vertebrae, and the like. The display module 30 may also be communicatively coupled to the processing module 20 to receive and display in real-time the tissue type in the staple line determined by the processing module 20. The type of tissue in the displayed lane may be viewable by the operator to facilitate the operator in determining whether the lane is a safe lane.

Referring to fig. 1, the system 1 may further include a storage module 40, and the storage module 40 may be used to store data or information. The data or information may include image information (e.g., a cross-sectional image of the patient's spine, an orthographic image of the patient's spine, a lateral image of the patient's spine, etc.), data or information related to the lanes (e.g., identification information for each lane, and angle, tissue information and tissue type, safety, etc. of the corresponding lane), or other data or information related to the spinal fixation procedure. The memory module 40 may be communicatively coupled to the measurement assembly 10, and data (e.g., angle of the staple, tissue information, etc.) measured by the measurement assembly 10 may be transmitted and stored in the memory module 40. The memory module 40 may also be communicatively coupled with the processing module 20 and/or the display module 30 to allow the processing module 20 and/or the display module 30 to obtain data or information stored in the memory module 40.

Although in the embodiment shown in fig. 1, the processing module 20, the display module 30, and the storage module 40 are shown as separate components. In other embodiments, however, the processing module 20, the display module 30, the storage module 40 may be integrated together, such as in a notebook computer, a tablet computer, a personal computer with a display screen, or the like.

Referring to fig. 2, fig. 2 shows a schematic structural view of a measurement assembly 10 according to an embodiment of the present invention. As shown in fig. 2, the measurement assembly 10 may have a tissue detection device 11, a first handle 12, a second handle 14, and an angle measurement device 13. The tissue detection device 11 may have a probe 111, and the probe 111 may be used to insert a target vertebra of a patient along a tract and obtain tissue information in the tract. Tissue information may include one or more of tissue impedance, light information associated with tissue (e.g., light reflectivity of tissue), force information associated with tissue (e.g., resistance to entry into tissue), and the like. In some embodiments, probe 111 may include electrodes for measuring tissue impedance, which may be used to determine different tissue types. Additionally or alternatively, the probe 111 may include a light sensor for sensing light information associated with tissue, e.g., light reflectivity of tissue, which sensed light information associated with tissue may be used to determine different tissue types. Additionally or alternatively, probe 111 may include force sensors for sensing force information associated with tissue, such as resistance to entry into tissue, which sensed force information associated with tissue may be used to determine different tissue types.

First handle 12 may have a first connection 121 and a second connection 123. The first connection portion 121 may be used to connect with the probe 111 to connect the probe 111 to the first handle 12. The second handle 14 may have a third connection portion 141 and a fourth connection portion 143. The third connection 141 may be used to connect with the angle measuring device 13 to connect the angle measuring device 13 to the second handle 14. In some embodiments, the connection between the angle measurement device 13 and the second handle 14 may be a detachable connection. In other embodiments, the angle measurement device 13 may be integrated within the second handle 14. Fourth coupling portion 143 is operable to mate with second coupling portion 123 of first handle 12 to rotatably couple second handle 14 and first handle 12 together. In other words, when matingly mounted together, the first handle 12 and the second handle 14 may rotate relative to one another.

Referring to fig. 3, fig. 3 shows a schematic view of a portion of the construction of a measurement assembly 10 according to an embodiment of the present invention. As shown in FIG. 3, the measurement assembly 10 may further include a connector 16, and the connector 16 may be at least partially positioned within the second handle 14. The first end 161 of the connector 16 may be adapted to electrically connect with the probe 111 and the second end 163 may be electrically connected with external circuitry. For example, when the second handle 14 is coupled to the first handle 12, the first end 161 of the connector 16, which is at least partially within the second handle 14, may be electrically coupled to the probe 111 coupled to the first handle 12. In some embodiments, the connector 16 may have a spring structure at the first end 161 that may allow the first end 161 of the connector 16 to remain electrically connected to the probe 111 at all times. For example, when the first handle 12 is rotated relative to the second handle 14 and thereby rotates the probe 111 coupled to the first handle 12 relative to the second handle 14, the first end 161 of the connector 16 having a spring structure may remain electrically coupled to the probe 111 at all times to transmit signals (e.g., tissue impedance signals, optical signals, force signals, etc.) acquired by the probe 111 to an external circuit. The external circuitry may be used to convert signals acquired by probe 111 (e.g., tissue impedance signals, optical signals, force signals, etc.) into electrical signals to determine the tissue type from the electrical signals. In some embodiments, the external circuit may be located within the angle measurement device 13, and the external circuit may be electrically connected with the second end 163 of the connector 16 when the angle measurement device 13 is connected to the second handle 14 via the third connection 141 of the second handle 14. In other embodiments, the external circuit may be located within the second handle 14 and electrically connected to the second end 163 of the connector 16.

Referring back to fig. 2, in operating the measurement assembly 10, the operator may place the head 113 of the probe 111 on or within the target vertebra and rotate the first handle 12 to rotate the probe 111 so that the head 113 of the probe 111 can break the target vertebra, while the operator applies force to the measurement assembly 10 along the longitudinal axis L of the probe 111 so that the probe 111 is inserted into and advanced within the target vertebra. The path along which the probe 111 advances within the targeted vertebra is referred to as the tract. The probe 111 advanced along the staple can measure tissue information in the staple to determine if the staple is safe. During the rotation of the first handle 12 by the operator, the second handle 14 and the angle measuring device 13 connected to the second handle can be kept stationary because the connection between the first handle 12 and the second handle 14 is a rotatable connection, so that the measuring accuracy of the angle measuring device 13 can be prevented from being affected by the rotation.

By using the measuring assembly 10 of the present application, the angle of the safety tract can be measured by the angle measuring device 13 while exploring the safety tract in the target vertebra by the probe 111 without degrading the measurement accuracy of the angle measuring device 13. When a plurality of pedicle screws are to be implanted in the spine of a patient and connecting rods are arranged among the pedicle screws, the tissue types in the screw channels and the angles of the screw channels are identified simultaneously, so that the operation time can be effectively reduced, the space distribution of the safety screw channels can be improved while the safety of the screw channels is ensured, the damage of the pedicle screws to the target vertebral structure is reduced, the installation difficulty of the connecting rods is reduced, and the correction force of the connecting rods arranged among vertebrae is optimized.

In addition to the components shown in fig. 1 (e.g., the measurement assembly 10, the processing module 20, the display module 30, the storage module 40), the system 1 may also include an open drill 51 for locating the start point of the staple channel, i.e., the feed point.

Referring to fig. 4, fig. 4 shows a schematic structural view of an open-circuit drill 51 according to an embodiment of the present invention. As shown in fig. 4. The first end 511 of the open-circuit drill 51 may be adapted to be connected to a power source (e.g., a motor) and the second end 513 may have a drill bit 514. In operation, the drill bit 514 of the open-circuit drill 51 may be driven by a power source to drill into a targeted vertebra. In some embodiments, the open drill 51 drilled into the target vertebra may be temporarily left on the target vertebra, and a medical imaging device (e.g., an X-ray imaging apparatus (X-RAY IMAGING, XR), such as a C-arm machine, etc.) may acquire a positive displacement medical image including the target vertebra and the open drill 51, which positive displacement medical image or a positive displacement camera image obtained by photographing the positive displacement medical image may be displayed on the display module 30 for viewing by an operator to confirm by the operator whether the open drill 51 has drilled into the target vertebra from the point of approach. If the open drill 51 is not drilling into the target vertebra from the point of approach, the position of the open drill 51 drilling into the target vertebra may be adjusted until it is confirmed that the open drill 51 is drilling into the target vertebra from the point of approach. The drill bit 514 of the open-circuit drill 51, which drills into the target vertebra from the point of approach, may drill a pit into the target vertebra, which may be used as the point of approach for the nail path to facilitate the operator's quick finding of the point of approach in a subsequent procedure. In addition, since the open drill 51 breaks the cortical bone, which is relatively hard in surface texture, of the target vertebra at the point of approach, other components (such as probe 111, k-wire, pedicle screw, etc.) may be subsequently used to access the target vertebra from the point of approach without the need for excessive force applied by the operator.

In addition, to facilitate rapid positioning of the feeding point with the open-circuit drill 51, the system 1 may further comprise a feeding point positioning device 52. Fig. 5 shows a schematic structural view of the feeding point positioning device 52 according to an embodiment of the present invention. As shown in fig. 5, the staple feeding spot positioning device 52 may comprise a sleeve 521, a slider 522, a transverse rod 523 and a longitudinal rod 524. The sleeve 521 may have a passage 525 therein, the passage 525 being operable to receive the open-path drill 51. The slider 522 may have a first channel and a second channel. A first channel of the slider 522 may be used to receive the transverse rod 523 and allow the slider 522 to move along the transverse rod 523, and a second channel may be used to receive the longitudinal rod 524 and allow the slider 522 to move along the longitudinal rod 524. As shown in fig. 5, the transverse rod 523 may have graduations thereon, and the transverse rod 523 may have an anchor 529 at its 0 graduation value, the anchor 529 being operable to be secured to a target vertebra of a patient, such as the inferior surface of the spinous process of the target vertebra. The longitudinal rod 524 may also have graduations thereon, and the sleeve 521 may be fixedly coupled to the longitudinal rod 524 at an end thereof adjacent to the 0 graduation of the longitudinal rod 524.

In operation, an operator may secure anchor 529 to a target vertebra of a patient (e.g., at the inferior surface of the spinous process of the target vertebra). Next, the operator may move the slider 522 along the lateral rod 523 inserted into the first passage of the slider 522 such that the slider 522 moves to the target lateral scale of the lateral rod 523, and move the longitudinal rod 524 in the second passage of the slider 522 such that the slider 522 is located at the target longitudinal scale of the longitudinal rod 524. Still next, the operator may insert the open-circuit drill 51 into the channel 525 from the rear end 526 of the sleeve 521 and extend the open-circuit drill 51 out of the channel 525 from the front end 528 of the sleeve 521, and the open-circuit drill 51 extending out of the channel 525 may contact and drill into the targeted vertebra. As previously described, the depressions drilled in the targeted vertebrae may be used as staple feeding points for the staple channels. The target lateral graduations may indicate a lateral distance of the access point relative to the inferior surface of the spinous process of the target vertebra (i.e., a distance of the access point from a midline of the target vertebra), and the longitudinal target graduations may indicate a longitudinal distance of the access point relative to the inferior surface of the spinous process of the target vertebra. In some embodiments, the lateral and longitudinal distances of the access point relative to the inferior surface of the spinous process of the targeted vertebra may be measured by the operator in advance in an orthographic image of the patient's spine. Fig. 6 shows a schematic representation of an orthographic view of a spine of a patient according to an embodiment of the present application. As shown in fig. 6, the insertion point a may have a lateral distance D1 with respect to the spinous process lower surface B of the target vertebra and the insertion point a may have a longitudinal distance D2 with respect to the spinous process lower surface B of the target vertebra. In some embodiments, the orthographic slice image shown in fig. 6 may include an orthographic slice medical image or an orthographic slice camera image. In the present application, the nail feeding point can be determined or confirmed by acquiring the normal patch image.

Referring back to fig. 5, there is shown in fig. 5a staple feeding point positioning device 52 having two sleeves 521, two sliders 522, one transverse rod 523 and two longitudinal rods 524, which can be used to simultaneously position two staple feeding points on both the left and right sides of a target vertebra. In other embodiments, the spot-advancing positioning device 52 may have only one sleeve 521, one slider 522, one transverse rod 523, and one longitudinal rod 524 for positioning a single spot on either side of the targeted vertebra.

In spinal surgery, it is often necessary to use medical images of the patient's spine. The medical image may be acquired by using a medical imaging apparatus (X-RAY IMAGING, XR), such as a C-arm machine, etc., e.g., an X-ray computed tomography (Computed Tomography, CT), a magnetic resonance imaging (Magnetic Resonance Imaging, MRI), etc. Medical images acquired using medical imaging devices typically have specialized medical image formats, such as MINC (Medical Imaging NetCDF) format, DICOM (DIGITAL IMAGING AND Communications IN MEDICINE) format, and the like. Such specialized medical image formats have placed limitations on the compatibility of medical images, processing speed, tool support, and application flexibility. In order to solve this problem, the present application proposes that a medical image can be taken with a camera when the medical image is acquired and displayed with a medical imaging device. The image captured by the camera is a camera image having a common image format (such as JPG/JPEG format, PNG format, etc.). Compared to medical images, camera images may have the advantages of 1. File volumes are typically smaller, suitable for fast storage and transmission and faster speeds in loading, editing and displaying, suitable for scenes that require fast processing and real-time display, 2. Higher compatibility, almost all operating systems, image processing software and web browsers support camera images, etc. By using the camera image instead of the medical image in spinal surgery, not only can display and process the camera image be allowed to be accomplished with the portable device, but also the time and cost of intra-operative image processing can be reduced. However, when a medical image is photographed with a camera, distortion of the camera image (e.g., distortion of the proportion of vertebral structures, shape, etc. within the camera image) may occur due to a problem of photographing angle, thereby affecting the rationality and accuracy of operations performed by an operator based on the camera image (e.g., selection of pedicle screw models, planning of screw paths, etc., which will be described in detail below). To this end, the application further proposes to further include a visualization module (not shown in the figures) in the system 1 for spinal fixation. The developing module may be configured as a polyhedron, such as a cube. The development module may include one or more calibration surfaces, each of which may have a pattern of known geometry therein, e.g., circular, rectangular, triangular, etc. The pattern in each calibration surface may be filled with a developing material (e.g., lead, zirconia, stainless steel, titanium alloy, tungsten-containing polymer, etc.). The visualization module may be mounted adjacent to a vertebra adjacent to a target vertebra of the patient such that the visualization module is also included in a medical image acquired using the medical imaging device including the target vertebra. When a medical image including a target vertebra and an visualization module is photographed using a camera, the obtained camera image may also include the target vertebra and the visualization module. Since the calibration face of the developing module has a pattern of known geometry, when the camera image is distorted, the pattern in the calibration face of the developing module in the camera image will also be distorted. The processing module 20 may be configured to receive a camera image from a camera and determine whether the camera image is distorted based on a pattern in a calibration surface of a development module in the camera image. When it is determined that there is distortion in the camera image, the processing module 20 may adjust the camera image to eliminate the distortion in the camera image. The above determination and adjustment of the distorted camera image may be accomplished using Zhang Zhengyou camera calibration methods. The Zhang Zhengyou camera calibration method is a known algorithm and is not described in detail herein.

In some embodiments, the development module may include a first calibration surface and a second calibration surface, which may be substantially 90 degrees from each other. After the visualization module is installed adjacent to (e.g., on or near) a target vertebra of the patient and the lateral and normal medical images of the patient's spine are acquired, respectively, using the medical imaging device, the acquired lateral medical images may include the target vertebra and the first calibration surface and the acquired normal medical images may include the target vertebra and the second calibration surface. The camera may obtain a side lobe camera image including the target vertebra and the first calibration surface by photographing a side lobe medical image including the target vertebra and the first calibration surface, and obtain an orthographic camera image including the target vertebra and the second calibration surface by photographing an orthographic medical image including the target vertebra and the second calibration surface. The processing module 20 may be further configured to receive a side-lobe camera image and a normal-lobe camera image from the camera, determine whether the side-lobe camera image is distorted based on the pattern in the first calibration surface in the side-lobe camera image, and determine whether the normal-lobe camera image is distorted based on the pattern in the second calibration surface in the normal-lobe camera image. When it is determined that there is distortion in the side-slice camera image and/or the front-slice camera image, the processing module 20 may adjust the corresponding camera image (i.e., the side-slice camera image and/or the front-slice camera image that is distorted) so as to cancel the distortion of the corresponding camera image. The display module 30 may be configured to receive the adjusted camera image (e.g., adjusted side-lobe camera image, adjusted normal-lobe camera image) from the processing module 20 and display the adjusted camera image.

Additionally, the developing module may further include a third calibration surface, which may be substantially 90 degrees from the first and second calibration surfaces. After the visualization module is installed adjacent to the target vertebra of the patient and a cross-sectional medical image of the patient's spine is acquired using the medical imaging device, the acquired cross-sectional medical image may include the target vertebra and the third calibration surface. The processing module 20 may be further configured to receive a cross-sectional camera image from the camera and determine whether the cross-sectional camera image is distorted based on the pattern in the third calibration surface in the cross-sectional camera image. When it is determined that the cross-sectional camera image is distorted, the processing module 20 may adjust the cross-sectional camera image to eliminate the distortion of the cross-sectional camera image. The display module 30 may be configured to receive the adjusted cross-sectional camera image from the processing module 20 and display the adjusted cross-sectional camera image.

In other embodiments, the development module may include only one calibration surface. When a respective medical image (e.g., a lateral slice medical image, an orthographic slice medical image, a cross-sectional medical image) is to be acquired, the respective medical image may be made to include the calibration surface and the target vertebra by adjusting the position of the calibration surface of the visualization module. For example, when a lateral patch medical image is to be acquired, the acquired lateral patch medical image may be made to include the calibration surface and the target vertebra by placing the visualization module with its calibration surface substantially parallel to the sagittal plane of the patient. When an orthographic medical image is to be acquired, the acquired orthographic medical image may be made to include the calibration surface and the target vertebrae by positioning the visualization module such that its calibration surface is substantially parallel to the patient's coronal plane. When a cross-sectional medical image is to be acquired, the acquired cross-sectional medical image may be made to include the calibration surface and the targeted vertebra by positioning the visualization module such that its calibration surface is substantially parallel to the cross-section of the patient.

In the present application, in addition to allowing the operator to explore the safe lane with the probe 111, the operator may be allowed to plan the lane on the image displayed by the display module 30 instead of or in addition to exploring the safe lane with the probe 111. In addition, the operator may also determine the point of approach on the image displayed by the display module 30, select an appropriate pedicle screw model, and the like. In some embodiments, the images displayed by display module 30 for determining the approach point, planning the approach, and/or selecting the appropriate pedicle screw model may include a lateral slice image (e.g., a lateral slice medical image, a lateral slice camera image), a normal slice image (e.g., a normal slice medical image, a normal slice camera image), a cross-sectional image (e.g., a cross-sectional medical image, a cross-sectional camera image), etc. of the patient's spine. When utilizing the camera image to determine the approach point, plan the approach path, and/or select an appropriate pedicle screw model, the camera image may be a distortion-free camera image or an adjusted camera image to ensure the rationality and accuracy of the approach point determination, approach path planning, and/or pedicle screw model selection.

The system 1 for spinal fixation may also include a user input device (not shown) that may receive an operator-entered pedicle screw model and an operator-entered horizontal and sagittal plane angle of the planned trajectory. The user input device may include a keyboard, mouse, touch screen, etc. In embodiments where the user input device comprises a touch screen, the touch screen may also serve as the display module 30.

The following describes a lane planning procedure in a spinal fixation procedure with reference to fig. 7. Fig. 7 shows a lane planning process 700 (hereinafter referred to as process 700) according to an embodiment of the present invention.

At step 701, a developing module is installed. In one embodiment, the visualization module may be mounted within the patient. In particular, the vertebral positioning device 61 can be mounted on a vertebra adjacent to the target vertebra. Fig. 8 shows a schematic structural view of a vertebral positioning device 61 according to an embodiment of the present invention. As shown in fig. 8, the vertebral positioning device 61 can include a vertebral fixation portion 611 and a placement portion 613. The vertebra fixation portion 611 may be coupled to the seating portion 613 and include screws that may be used to secure the vertebra positioning device 61 to a vertebra adjacent to a target vertebra of a patient, such as to a spinous process of a vertebra adjacent to the target vertebra. The seating portion 613 may be used for a developing module to be mounted thereon. When the vertebra positioning device 61 is fixed to a vertebra adjacent to the target vertebra, the visualization module may be installed near the target vertebra by installing the visualization module in the placement portion 613 of the vertebra positioning device 61. In other embodiments, the visualization module may be mounted outside the patient. In particular, the bedside positioning device 63 may be mounted outside the patient. Fig. 9 shows a schematic structural view of a bedside positioning device 63 according to an embodiment of the invention. As shown in fig. 9, the bedside positioning device 63 may include a bed frame fixing portion 631, a vertical positioning arm 633, a horizontal positioning arm 635, and a fitting portion 637. The bedframe fixing portion 631 can be used to fix the bedside positioning device 63 to the patient's bedframe. The vertical positioning arm 633 may be coupled to the frame fixing portion 631. The horizontal positioning arm may be connected to the vertical positioning arm 633. The fitting portion 637 may be connected to the horizontal positioning arm 635 and used for mounting a developing module thereon. The bedside positioning device 63 may also include a vertical adjustment knob 632 and a horizontal adjustment knob 634. The vertical adjustment knob 632 may be used to adjust the vertical distance of the fitting portion 637 with respect to the frame fixing portion 631, and the horizontal adjustment knob 634 may be used to adjust the horizontal distance of the fitting portion 637 with respect to the frame fixing portion 631. When the bedside positioning device 63 is secured to the patient's bedframe, the visualization module may be mounted adjacent to the targeted vertebra by mounting the visualization module to the mounting portion 637 of the bedside positioning device 63 and optionally adjusting the vertical adjustment knob 632 and/or the horizontal adjustment knob 634.

At step 703, a cross-sectional image of the patient's spine is acquired. In some embodiments, the cross-sectional image may include a cross-sectional medical image or a cross-sectional camera image. The cross-sectional medical image may be acquired directly by utilizing a second medical imaging apparatus (e.g., a computed tomography device (Computed Tomography, CT), a magnetic resonance imaging device (Magnetic Resonance Imaging, MRI), etc.). The cross-sectional camera image may be obtained by taking a cross-sectional medical image.

At step 705, a lateral slice image of the patient's spine is acquired. In some embodiments, the side-slice images may include side-slice image medical images or side-slice camera images. The side-slice medical image may be acquired directly by using a first medical imaging device (e.g., an X-ray imaging apparatus (X-RAY IMAGING, XR), such as a C-arm machine, etc.). The side-lobe camera image may be obtained by taking a side-lobe medical image.

At step 707, a pedicle screw model is selected. In some embodiments, the operator may select the image to be displayed as desired. For example, the operator may select to display a side lobe image and a cross-sectional image and select an appropriate pedicle screw model based on the displayed side lobe image and cross-sectional image. Fig. 10 shows a first display interface of the display module 30 according to an embodiment of the invention. The left side of fig. 10 shows a side panel image, and the right side shows a cross-sectional image. The displayed side piece image may be a side piece medical image or a side piece camera image. The displayed cross-sectional image may be a cross-sectional medical image or a cross-sectional camera image. To ensure that the operator is able to correctly enter or select the appropriate pedicle screw model, the displayed side-lobe camera image is an undistorted side-lobe camera image or an adjusted side-lobe camera image, and the displayed cross-sectional camera image is an undistorted cross-sectional camera image or an adjusted cross-sectional camera image. The operator may input or select an appropriate pedicle screw model using a user input device (e.g., within the upper right box of fig. 10) based on the image displayed by display module 30. After the pedicle screw model is entered or selected, the display module 30 may superimpose the pedicle screw model on the displayed image. Fig. 11 illustrates a second display interface of the display module 30 according to an embodiment of the present invention. The left side of fig. 11 shows a lateral slice image superimposed with a pedicle screw model, the right side shows a cross-sectional image superimposed with a pedicle screw model, and the upper right box shows specific information of the entered or selected pedicle screw model, e.g., diameter, length, etc.

At step 709, a tack is planned. In some embodiments, the operator may determine the staple entry point and input the sagittal and horizontal angles of the planned staple channel using a user input device. Fig. 12 shows a third display interface of the display module 30 according to an embodiment of the invention. The operator may directly enter values for the sagittal and horizontal angles of the planned trajectory within the upper right box of fig. 12 after determining the approach point. After inputting the value of the sagittal plane angle of the planned trajectory, the pedicle screw model shown on the left side of fig. 12 superimposed on the lateral plate image may be rotated about the screw insertion point to adjust the position of the pedicle screw model on the lateral plate image so as to correspond to the inputted sagittal plane angle. After inputting the value of the horizontal plane angle of the planned trajectory, the pedicle screw model superimposed on the cross-sectional image shown on the right side of fig. 12 may be rotated about the screw-in point to adjust the position of the pedicle screw model on the cross-sectional image so as to correspond to the inputted horizontal plane angle. An operator may determine whether his planned trajectory is appropriate based on the location of the pedicle screw model on the lateral and/or cross-sectional images. For example, when at least a portion of the shaft of the pedicle screw model is shown traversing cortical bone of the target vertebra at a location other than the point of approach, it may be determined that the planned trajectory is unsuitable. When the entire shaft of the pedicle screw model is shown not passing through cortical bone of the targeted vertebra at a location other than the point of approach, the planned trajectory may be determined to be appropriate. In addition, the operator may enter the sagittal plane angle of the planned trajectory by first selecting the pedicle screw model superimposed on the lateral plate image, dragging or rotating the pedicle screw model to adjust its position on the lateral plate image until the adjusted position of the pedicle screw model on the lateral plate image meets expectations, e.g., the entire shaft of the pedicle screw model is shown not passing through the cortical bone of the target vertebra at other locations than the approach point. Likewise, the operator may enter the planned trajectory's horizontal plane angle by first selecting the pedicle screw model superimposed on the cross-sectional image, dragging or rotating the pedicle screw model to adjust its position on the cross-sectional image until the adjusted position of the pedicle screw model on the cross-sectional image meets expectations, e.g., the entire shaft of the pedicle screw model is shown not passing through the cortical bone of the target vertebra at a location other than the point of approach. The corresponding sagittal and horizontal angles may be displayed in real time within the upper right square box of fig. 12 as the pedicle screw model is dragged or rotated.

At step 711, the lane planning process 700 ends.

It should be understood that the above steps of the lane planning process are exemplary and are not intended to be limiting. One skilled in the art may add one or more steps, or delete one or more of the above steps, or merge or replace one or more of the above steps, or adjust the order of one or more of the above steps as desired.

In some embodiments, after the lane planning is completed, the operator may form a lane within the target vertebra of the patient based on the planned lane. The operator can complete the formation of the staple channel using the guide 70. Fig. 13 shows a schematic structural view of a guide 70 according to an embodiment of the present invention. As shown in fig. 13, the guide 70 may include a sleeve 71 and a mounting portion 73. The sleeve 71 may have a passageway therein that may be used to receive a track-extending member (e.g., a k-wire). The track extender may be used to be inserted into a target vertebra of a patient to form a staple track within the target vertebra. The mounting portion 73 may be connected to the cannula 71 and used for mounting the angle measuring device 13 thereon, and the angle measuring device 13 mounted to the mounting portion 73 may be used to measure the horizontal and sagittal angles of the tract to be formed during insertion of the tract extender into the targeted vertebra to form the tract.

In operation, an operator may place a track extender (e.g., a k-wire) within the cannula 71 of the guide 70 and mount the angle measurement device 13 on the mount 73 of the guide 70. The operator may then align the stent extending from the end 711 of the cannula 71 with the approach point on the patient's target vertebra and rotate the guide 70 about the approach point until the horizontal and sagittal angles measured by the angle measurement device 13 mounted on the mounting portion 73 of the guide 70 coincide with the horizontal and sagittal angles of the planned tract, respectively. The horizontal plane angle and the sagittal plane angle measured by the angle measuring device 13 may be used to indicate the tack way to be formed during rotation of the guide device 70, and the display module 30 may be configured to receive and display the horizontal plane angle and the sagittal plane angle measured by the angle measuring device 13 in real time, further superimpose and display the tack way to be formed on the cross-sectional medical image or the cross-sectional camera image superimposed with the planned tack way based on the received horizontal plane angle, and further superimpose and display the tack way to be formed on the side piece camera image superimposed with the planned tack way based on the received sagittal plane angle. Fig. 14 shows a fourth display interface of the display module 30 according to an embodiment of the invention. The left side of fig. 14 shows a side-slice image with the planned and to-be-formed tacks superimposed, the right side shows a cross-sectional image with the planned and to-be-formed tacks superimposed, the upper right corner shows the sagittal and horizontal angles of the planned and to-be-formed tacks, and the lower right corner shows the sagittal and horizontal angles of the to-be-formed tacks. In the embodiment of fig. 14, an icon showing a tack (e.g., planned tack, tack to be formed) is shown as a pedicle screw model including a head and a tack, with the tack of the pedicle screw model being used to show the position of the tack in a target vertebra. In other embodiments, the lanes may be presented by other types of icons (e.g., icons having only similar spikes as described above). When the sagittal and horizontal angles of the tract to be formed, as measured by the angle measuring device 13, coincide with the sagittal and horizontal angles of the planned tract, respectively, in the side piece image and the cross-sectional image shown in fig. 14, the tract to be formed overlaps with the planned tract, at which point the operator may insert the tract extender into the targeted vertebra of the patient to form the tract. The operator may then withdraw the distraction member and implant pedicle screws along the screw path formed by the distraction member.

In other embodiments, after the lane planning is completed, the operator may confirm whether the planned lane is safe using the measurement assembly 10. Specifically, the operator may align the probe 111 with the feed point and rotate the measurement assembly 10 about the feed point until the angle measured by the angle measurement device 13 coincides with the angle of the planned lane. At this point, the operator may advance the probe 111 along the planned trajectory. During rotation of the measurement assembly 10, the display module 30 may show a display interface similar to that of fig. 14 to facilitate an operator in determining whether the probe 111 is to be inserted into a target vertebra along a planned trajectory. During advancement of the probe 111 along the planned tract, the probe 111 may obtain tissue information in the planned tract. Based on the obtained tissue information in the planned nail path, it can be confirmed whether the planned nail path is safe or not. For example, if tissue information measured during the advancement of probe 111 to a target depth (e.g., the target depth may be consistent with the length of the pedicle screw portion) is indicative of safety, then planned lane safety may be confirmed. When confirming the planned trajectory safety, the operator may form a trajectory within the target vertebra of the patient based on the planned trajectory. When tissue information measured during advancement of the probe 111 indicates an unsafe condition, the operator may adjust the advancement of the probe 111 in real time to determine a safe trajectory and obtain the sagittal and horizontal angles of the safe trajectory using the angle measurement device 13.

Additionally, in embodiments where multiple pedicle screws are to be implanted within a patient's spine, the spatial relationship between multiple planned or multiple safety lanes may be determined prior to formation of the respective lanes with a lane extender (e.g., k-wire). Fig. 15 shows a fifth display interface of the display module 30 according to an embodiment of the present invention. The left side of fig. 15 shows a side panel image with a plurality (3 shown in fig. 15) of planned tacks or a plurality of safety tacks superimposed, and the right side shows a cross-sectional image with a plurality (2 shown in fig. 15) of planned tacks or a plurality of safety tacks superimposed. Based on the side piece image superimposed with the plurality of planned lanes or the plurality of safety lanes shown in fig. 15, parallelism between the plurality of planned lanes or the plurality of safety lanes can be determined. Based on the cross-sectional image of the superimposed planned nail paths or safety nail paths shown in fig. 15, symmetry between the planned nail paths or safety nail paths can be determined. When the spatial relationship between the plurality of planned lanes or the plurality of safety lanes meets the respective requirements (e.g., parallelism requirement, symmetry requirement), the lane-expanding members may be utilized to form the respective lanes. The formed lanes can be used to guide the implantation of pedicle screws.

One or more of the modules (e.g., processing module 20, display module 30) in the various embodiments of the disclosure may be implemented in hardware. For example, it may be implemented using at least one of Application Specific Integrated Circuits (ASICs), digital signal processors (DSPs, DIGITAL SIGNAL processors), digital signal processing devices (DSPDs, DIGITAL SIGNAL processing devices), programmable logic devices (PLDs, programmable logic devices), field programmable gate arrays (FPGAs, field programmable GATE ARRAYS), processors (processors), controllers (controllers), micro-controllers (micro-controllers), micro-processors (micro-processors), and electrical units for performing other functions.

Portions of embodiments of the present disclosure may be provided as a computer program product that may include a computer-readable medium having stored thereon computer program instructions that may be used to program a computer (or other electronic devices) to be executed by one or more processors to perform a process according to some embodiments. Computer-readable media may include, but is not limited to, magnetic disks, optical disks, read-only memory (ROM), random Access Memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic or optical cards, flash memory, or other types of computer-readable media suitable for storing electronic instructions. Furthermore, embodiments may also be downloaded as a computer program product, wherein the program may be transferred from a remote computer to a requesting computer. In some embodiments, the non-transitory computer-readable storage medium has stored thereon data representing sequences of instructions that, when executed by a processor, cause the processor to perform certain operations, such as one or more steps in process 700 described above in connection with fig. 7.

The following is an additional non-limiting example list that may be in accordance with one or more techniques of this disclosure.

Example A1. A system for spinal fixation, the system comprising:

A visualization module comprising one or more calibration surfaces, each calibration surface having therein a pattern of known geometry, the pattern being filled with a visualization material, the visualization module for mounting adjacent to a target vertebra of a patient to facilitate acquisition of a medical image comprising the visualization module and the target vertebra using a medical imaging device;

a camera for capturing the medical image including the visualization module and the target vertebra to obtain a camera image;

a processing module configured to:

Receiving the camera image from the camera;

Determining whether the camera image is distorted based on a pattern in a calibration surface of a development module in the camera image, and

When it is determined that the camera image has distortion, adjusting the camera image to eliminate the distortion;

a display module configured to:

receiving an adjusted camera image from the processing module, and

The adjusted camera image is displayed.

Example A2. The system of example A1, the developing module including a first calibration surface and a second calibration surface, the first calibration surface being perpendicular to the second calibration surface,

The medical imaging device is for acquiring a lateral plate medical image including a first calibration surface of the visualization module and the target vertebra, and the medical imaging device is for acquiring an anterior plate medical image including a second calibration surface of the visualization module and the target vertebra,

The camera is used for shooting the side piece medical image to obtain a side piece camera image, and the camera is used for shooting the normal piece medical image to obtain a normal piece camera image,

The processing module is further configured to:

receiving the side-lobe camera image and the normal-lobe camera image from the camera;

determining whether the side-piece camera image is distorted based on a pattern in a first calibration surface of a developing module in the side-piece camera image;

Determining whether the positive-displacement camera image is distorted based on the pattern in the second calibration surface of the developing module in the positive-displacement camera image, and

When the side-position sheet camera image and/or the positive-position sheet camera image are/is determined to have distortion, the corresponding camera image is adjusted so as to eliminate the distortion.

Example A3. The system of example A2, further comprising a user input device to receive a user input of a pedicle screw model,

The display module is for communicative coupling with the user input device and is further configured for:

displaying a cross-sectional image including the target vertebra, the cross-sectional image including a cross-sectional medical image or a cross-sectional camera image, the cross-sectional medical image being acquired with the medical imaging device, the cross-sectional camera image being acquired with the camera capturing the cross-sectional medical image, the cross-sectional camera image being a distortion-free camera image or an adjusted camera image;

displaying a side lobe image comprising the target vertebra, the side lobe image comprising a side lobe medical image or a side lobe camera image, the side lobe camera image being a distortion-free camera image or an adjusted camera image;

Receiving the pedicle screw model from the user input device;

the pedicle screw model is displayed superimposed on a side lobe image including the target vertebra and superimposed on a cross-sectional image including the target vertebra.

Example A4. The system of example A3, the user input device to further receive user input of a horizontal plane angle and a sagittal plane angle of the planned trajectory,

The display module is further configured to:

receiving a horizontal plane angle and a sagittal plane angle of the planned trajectory from the user input device;

Displaying the planned nail path superimposed on a cross-sectional image including the target vertebra based on the horizontal plane angle of the planned nail path, and

And superposing and displaying the planned nail path on a lateral slice image comprising the target vertebra based on the sagittal plane angle of the planned nail path.

Example A5 the system of example A4, further comprising a guide device comprising:

a cannula having a passage therein for receiving a channel-expanding member for insertion into the target vertebra to form a staple channel therein, and

A mounting portion connected to the cannula and for mounting thereon an angle measuring device, the angle measuring device mounted to the mounting portion for measuring a horizontal plane angle and a sagittal plane angle of a tract to be formed during insertion of the tract extender into the target vertebra to form the tract,

The display module is further configured to:

Receiving from the angle measurement device a horizontal plane angle and a sagittal plane angle of the tract to be formed;

further superimposedly displaying the planned nail path on a cross-sectional image including the target vertebra superimposed with the planned nail path based on the received horizontal plane angle of the nail path to be formed, and

Based on the received sagittal plane angle of the tract to be formed, the tract to be formed is further displayed superimposed on the lateral slice camera image including the target vertebra superimposed with the planned tract.

Example A6 the system of example A1, further comprising a vertebra positioning device comprising:

A vertebra fixation portion for securing the vertebra positioning device to a vertebra adjacent to a target vertebra of the patient;

A mounting portion connected to the vertebra fixing portion and for mounting the developing module thereon.

Example A7 the system of example A1, further comprising a bedside positioning device comprising:

A bed frame fixing part for fixing the bedside positioning device to a bed frame;

A vertical positioning arm connected to the bed frame fixing part;

A horizontal positioning arm connected to the vertical positioning arm, and

And a fitting portion connected to the horizontal positioning arm and for mounting the developing module thereon.

Example A8 the system of example A1, further comprising an open-circuit drill having one end for connection to a power source and the other end having a drill bit for drilling a pit in a target vertebra of the patient, the pit being used as a staple feeding point for a staple channel.

Example A9 the system of example A8, the system further comprising a staple feeding point positioning device comprising:

a sleeve having a passage therein for receiving the open drill;

A transverse bar having graduations thereon;

A longitudinal rod having graduations thereon and having one end fixedly connected to the sleeve, and

A slider having a first channel for receiving the transverse rod and allowing the slider to move along the transverse rod and a second channel for receiving a longitudinal rod and allowing the slider to move along the longitudinal rod.

Example a10 the system of example A6, the transverse rod having a detent at the 0 scale for securing to the inferior surface of the spinous process of the target vertebra,

One end of the longitudinal rod near the 0 scale is fixedly connected to the sleeve.

Example B1. A system for spinal fixation, the system comprising:

A measurement assembly, the measurement assembly comprising:

a tissue detection device comprising a probe for insertion into a target vertebra of a patient along a tract and obtaining tissue information in the tract, and

An angle measurement device configured to be detachably connected to the tissue detection device;

a processing module for communicative coupling with the measurement assembly and configured for:

Receiving in real time tissue information acquired by the probe during insertion into a target vertebra of the patient along a current tract, and

Determining in real time, based on the received tissue information, a tissue type in the current lane to determine whether the current lane is a safe lane, and

Wherein the angle measurement device is configured to measure an angle of each of a plurality of safety lanes for determining a spatial relationship between the plurality of safety lanes.

Example B2 the system of example B1, the spatial relationship between the plurality of safety lanes comprising parallelism between the plurality of safety lanes located on different target vertebrae and symmetry between the plurality of safety lanes located on the same target vertebrae,

Determining the plurality of safety lanes as available lanes when at least one of the following is satisfied:

Parallelism between multiple safety lanes located on different target vertebrae meets parallelism requirements;

symmetry between safety lanes located on the same target vertebra meets the symmetry requirement.

Example B3 the system of example B1, the measurement assembly further comprising:

A first handle having a first connection portion for connecting the probe to the first handle and a second connection portion, and

A second handle having a third connection for connecting the angle measurement device to the first handle and a fourth connection for mating with the second connection of the first handle to rotatably connect the second handle and the first handle together.

Example B4 the system of example B3, the measurement assembly further comprising a connector having a first end for electrical connection with the probe and a second end for electrical connection with an external circuit,

Wherein the connector has a spring structure at the first end configured for maintaining the first end of the connector in electrical connection with the probe at all times when the probe is operated to rotate.

Example B5 the system of example B1, further comprising an open-circuit drill having one end for connection to a power source and the other end having a drill bit for drilling a pit in a target vertebra of the patient, the pit being used as a staple feeding point for a staple channel.

Example B6 the system of example B5, further comprising a staple feeding point positioning device comprising:

a sleeve having a passage therein for receiving the open drill;

A transverse bar having graduations thereon;

Example B7 the system of example B6, the transverse rod having a detent at the 0 scale for securing to the inferior surface of the spinous process of the target vertebra,

The system of any of examples B8-B7, further comprising a display module for communicatively coupling with the measurement assembly and the processing module and configured for:

receiving the tissue type in the corresponding nail path determined by the processing module in real time;

displaying the received tissue type in the current nail path in real time;

Receiving in real time the angle of each of the plurality of safety lanes measured by the angle measuring device, and

Based on the received angle of each of the plurality of safety lanes, the plurality of safety lanes are displayed in real-time for viewing by an operator to determine a spatial relationship between the plurality of safety lanes.

Example B9 the system of example B8, the angles including a horizontal plane angle and a sagittal plane angle, the display module further configured to:

displaying the plurality of safety lanes on a cross-sectional image of the patient's spine based on a horizontal plane angle of each of the plurality of safety lanes, and

The plurality of safety lanes are displayed on a lateral slice image of the patient's spine based on a sagittal plane angle of each of the plurality of safety lanes.

Example B10 the system of example B8, further comprising a development module comprising one or more calibration surfaces, each calibration surface having a pattern therein of known geometry, the pattern being filled with a development material,

The visualization module is configured to be mounted adjacent to a target vertebra of the patient to facilitate acquisition of a medical image including the visualization module and the target vertebra using a medical imaging device.

Example B11 the system of example B10, further comprising a camera to capture the medical image comprising the visualization module and the target vertebra to obtain a camera image,

The processing module is further configured to:

Receiving the camera image from the camera;

When it is determined that the camera image has distortion, the camera image is adjusted to eliminate the distortion,

The display module is further configured to:

receiving an adjusted camera image from the processing module, and

The adjusted camera image is displayed.

Example B12 the system of example B11, the developing module including a first calibration surface and a second calibration surface, the first calibration surface being perpendicular to the second calibration surface,

The processing module is further configured to:

Example B13 the system of example B12, further comprising a user input device to receive a user-entered pedicle screw model,

Receiving the pedicle screw model from the user input device;

Example B14 the system of example B13, the user input device to further receive user input of a horizontal plane angle and a sagittal plane angle of the planned trajectory,

The display module is further configured to:

Example B15 the system of example B14, further comprising a guide comprising:

A mounting portion connected to the cannula and for mounting the angle measuring device thereon, the angle measuring device mounted to the mounting portion for measuring a horizontal plane angle and a sagittal plane angle of a nail tract to be formed during insertion of the tract extender into the target vertebra to form the nail tract,

The display module is further configured to:

Example B16 the system of example B14, the current lane comprising the planned lane,

The probe is configured to obtain tissue information in the planned nail path during insertion of the target vertebra along the planned nail path,

The angle measurement device is configured to measure an angle during insertion of the probe into the target vertebra to determine whether the probe is to be inserted into the target vertebra along the planned trajectory.

Example B17 the system of example B10, further comprising a vertebra positioning device comprising:

Example B18 the system of example B10, further comprising a bedside positioning device comprising:

A vertical positioning arm connected to the bed frame fixing part;

A horizontal positioning arm connected to the vertical positioning arm, and

While the invention has been described in terms of the preferred embodiments of the present disclosure, it is not intended to be limited thereto but only by the scope set forth in the following claims. It will be appreciated by those skilled in the art that changes and modifications may be made to the embodiments described herein without departing from the invention in its broader spirit and scope as set forth in the appended claims.

Claims

1. A system for spinal fixation, the system comprising:

A measurement assembly, the measurement assembly comprising:

Determining, in real time, a tissue type in the current lane based on the received tissue information, so as to determine whether the current lane is a safe lane;

Wherein the angle measurement device is configured to measure an angle of each of a plurality of safety lanes for determining a spatial relationship between the plurality of safety lanes, wherein the spatial relationship between the plurality of safety lanes includes parallelism between the plurality of safety lanes on different target vertebrae and symmetry between the plurality of safety lanes on the same target vertebrae,

Wherein the plurality of safety lanes are determined to be available lanes when at least one of the following is satisfied:

2. The system of claim 1, wherein the measurement assembly further comprises:

A second handle having a third connection for connecting the angle measurement device to the second handle and a fourth connection for mating with the second connection of the first handle to rotatably connect the second handle and the first handle together.

3. The system of claim 2, wherein the measurement assembly further comprises a connector having a first end for electrical connection with the probe and a second end for electrical connection with an external circuit,

4. The system of claim 1, further comprising an open-circuit drill having one end for connection to a power source and the other end having a drill bit for drilling a pit in a target vertebra of the patient, the pit being used as a staple feeding point for a staple channel.

5. The system of claim 4, further comprising a staple feeding point positioning device, the staple feeding point positioning device comprising:

a sleeve having a passage therein for receiving the open drill;

A transverse bar having graduations thereon;

6. The system of claim 5, wherein,

The transverse rod has a locating portion at the 0 scale for securing to the inferior surface of the spinous process of the target vertebra,

7. The system of any of claims 1-6, further comprising a display module for communicatively coupling with the measurement assembly and the processing module and configured for:

displaying the received tissue type in the current nail path in real time;

8. The system of claim 7, wherein the angles comprise a horizontal plane angle and a sagittal plane angle, the display module further configured to:

9. The system of claim 7, further comprising a development module comprising one or more calibration surfaces, each calibration surface having a pattern of known geometry therein, the pattern being filled with a development material,

10. The system of claim 9, further comprising a camera for capturing the medical image including the visualization module and the target vertebra to obtain a camera image,

The processing module is further configured to:

Receiving the camera image from the camera;

The display module is further configured to:

receiving an adjusted camera image from the processing module, and

The adjusted camera image is displayed.

11. The system of claim 10, wherein the developing module comprises a first calibration surface and a second calibration surface, the first calibration surface being perpendicular to the second calibration surface,

The processing module is further configured to:

12. The system of claim 11, further comprising a user input device for receiving a user-entered pedicle screw model,

Receiving the pedicle screw model from the user input device;

13. The system of claim 12, wherein the user input device is configured to further receive user input of a horizontal plane angle and a sagittal plane angle of the planned trajectory,

The display module is further configured to:

14. The system of claim 13, further comprising a guide device, the guide device comprising:

The display module is further configured to:

15. The system of claim 13, wherein the current lane comprises the planned lane,

The probe is configured to measure tissue information in the planned nail path during insertion of the target vertebra along the planned nail path,

16. The system of claim 9, wherein the system comprises a plurality of sensors, the system further includes a vertebral positioning device comprising:

17. The system of claim 9, further comprising a bedside positioning device, the bedside positioning device comprising:

A vertical positioning arm connected to the bed frame fixing part;

A horizontal positioning arm connected to the vertical positioning arm, and