Non-invasive auxiliary positioning device

Abstract

The application relates to the technical field of medical devices, and provides a noninvasive auxiliary positioning device, which comprises a positioning navigation system and a tracer. The tracer is used for being attached to the skin of a patient, comprises a tracer frame used for being arranged around the periphery of a surgical incision of the patient, and is provided with a plurality of optical markers. The plurality of optical markers are suitable for being tracked and recognized by the positioning navigation system to position the surgical incision and the tissue under the surgical incision. According to the technical scheme, when the patient is operated, an incision for mounting a positioning auxiliary device does not need to be additionally formed outside the originally planned area of the surgical incision of the patient, the additional surgical trauma to the patient is avoided, the safety of the operation of the patient is improved, and the accuracy of the operation of the patient is improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a non-invasive assisted positioning device. Background Technology

[0002] With the increasing application of navigation systems in orthopedic surgery, the problems encountered in using these systems are also growing. For example, when locating the patient's spine during surgery, an additional incision for the patient tracker needs to be made around the surgical incision before clamping the tracker to the bony prominence of the spine. This incision process can easily lead to bleeding and trauma. Alternatively, using Kirschner wires to directly insert into the bony prominence of the spine for location leaves Kirschner wire scars and can easily cause instability in the fixation of the patient tracker. Precise positioning of the spinal bony structures during surgery is crucial for surgical success. However, this method of positioning with a patient tracker not only adds extra surgical wounds, causing pain during and after surgery, increasing the dosage of anesthetic, and prolonging the operation time, but also has disadvantages such as poor positioning stability and insufficient reliability, making it difficult to meet the high standards of surgical precision required. Summary of the Invention

[0003] The purpose of this application is to provide a non-invasive auxiliary positioning device that eliminates the need for additional incisions outside the original surgical incision area for installing positioning aids during patient surgery. This avoids additional surgical trauma to the patient, improves the safety of the surgery, and helps to improve the accuracy of the surgery.

[0004] This application provides a non-invasive assisted positioning device, including: a positioning and navigation system; a tracer, the tracer being used to fit against the patient's skin, including a tracer frame for surrounding the patient's surgical incision, the tracer frame having multiple optical markers, the multiple optical markers being adapted to be tracked and identified by the positioning and navigation system to locate the surgical incision and the tissue below the surgical incision.

[0005] In the above-described process, during surgery, a tracer is attached to the patient's skin. The tracer includes a tracer frame that surrounds the surgical incision on the patient's skin. Multiple optical markers on the tracer frame are matched with a positioning and navigation system. The positioning and navigation system tracks and identifies these optical markers to locate the surgical incision and the tissue beneath it. This eliminates the need for an additional surgical incision near the surgical incision to fix the tracer; the tracer is directly attached to the patient's skin and matched with the positioning and navigation system, thus reducing patient pain. Furthermore, with the tracer attached to the patient's skin, it can effectively monitor and provide feedback on dynamic changes during physiological movements such as breathing or bowel movements, thereby improving surgical precision.

[0006] In some embodiments, the tracer frame includes a first frame for conforming to the patient's skin, and the first frame is provided with a plurality of optical markers spaced apart.

[0007] In the above implementation process, the tracking frame includes a first frame that adheres to the patient's skin surface. The surgical incision is located within the first frame. Multiple optical markers are provided on the first frame, spaced apart from each other. At least four optical markers are selected to match the positioning and navigation system. The positioning and navigation system tracks and identifies these markers, thereby locating the surgical incision and the tissue beneath it.

[0008] For example, at least four selected optical marks are anisotropically distributed on the first frame, wherein the anisotropic distribution means that the positional distribution of the four or more optical marks on one side of the first frame is not symmetrical, and the lengths of the lines connecting each pair of optical marks are not the same.

[0009] In some embodiments, the tracer frame further includes a second frame for conforming to the patient's skin, the second frame being located inside the first frame and detachably connected to the first frame, and the second frame having a plurality of optical markers spaced apart.

[0010] In the above implementation process, the area of ​​the second frame is smaller than that of the first frame. In addition, the first frame and the second frame are detachably connected. Through the above settings, doctors can select the appropriate frame according to the size of the patient's surgical incision. By matching the optical marker with the positioning and navigation system, the surgical incision and the tissue under the surgical incision can be located, thereby improving the accuracy of the surgery and providing more operable solutions for the surgery.

[0011] For example, if the length of the surgical incision is greater than the length of the diagonal of the second frame, it means that the second frame cannot enclose the surgical incision within the second frame. In this case, the doctor needs to attach the first frame to the patient's skin surface so that the surgical incision is located within the first frame. At least four optical markers are selected on the first frame to match the positioning and navigation system, thereby locating the surgical incision and the tissue under the surgical incision and improving the positioning accuracy.

[0012] If the length of the surgical incision is less than the diagonal length of the second frame, the doctor can attach the second frame to the patient's skin surface, placing the surgical incision within the second frame. At least four optical markers on the second frame are then matched with the positioning and navigation system to locate the surgical incision and the tissue beneath it. Alternatively, the first frame can be attached to the patient's skin, and the optical markers on the first frame can be matched with the positioning and navigation system. Understandably, when using either the first or second frame, the positioning accuracy of the second frame is better than that of the first frame because the area of ​​the second frame is smaller.

[0013] Of course, since the second frame is detachably connected to the first frame, the surgeon can also connect the first and second frames together and attach them to the patient's skin surface, placing the surgical incision within the second frame. Optical markers are selected on both the first and second frames, with at least four anisotropic markers chosen to match the positioning and navigation system, thereby locating the surgical incision and the tissue beneath it. For example, two markers can be selected on the first frame and two on the second frame, or one on the first frame and three on the second. Using two frames makes it easier for the selected optical markers to match with the positioning and navigation system, improving matching efficiency and reducing surgical time. Furthermore, using two frames provides more operational options for the surgery, ensuring its smooth execution.

[0014] In some embodiments, the tracer frame further includes a third frame for conforming to the patient's skin, the third frame being located inside the second frame and detachably connected to the second frame, the third frame having a plurality of optical markers spaced apart thereon.

[0015] In the above implementation process, the area of ​​the third frame is smaller than that of the second frame. In addition, the third frame is detachably connected to the second frame. Through the above settings, doctors can select the appropriate frame according to the size of the patient's surgical incision. By matching the optical marker with the positioning and navigation system, the surgical incision and the tissue under the surgical incision can be located, thereby improving the accuracy of the surgery.

[0016] For example, if the length of the surgical incision is less than the length of the diagonal of the third frame, the doctor can choose to use one frame based on the length of the patient's surgical incision. For instance, the doctor can attach the third frame to the patient's skin surface so that the surgical incision is located within the third frame. At least four optical markers on the third frame can be matched with the positioning and navigation system to locate the surgical incision and the tissue beneath it. Alternatively, the second or first frame can be attached to the patient's skin surface, providing the doctor with more options. When using one of the frames, the positioning accuracy of the third frame is better than that of the second and first frames.

[0017] Of course, when the length of the surgical incision is less than the length of the diagonal of the third frame, the doctor can also choose to connect two frames or three frames to each other, all of which are attached to the patient's skin surface. For example, the second frame can be connected to the first frame, and at least four optical markers can be selected on the first and second frames to match the positioning and navigation system to locate the surgical incision and the tissue under the surgical incision; or the second frame can be connected to the third frame, and at least four optical markers can be selected on the third and second frames to match the positioning and navigation system to locate the surgical incision and the tissue under the surgical incision.

[0018] The third, second, and first frames can be interconnected and all fitted to the patient's skin surface. At least four optical markers can be selected on the third, second, and first frames. This setup provides doctors with more options. Furthermore, selecting multiple frames makes it easier to ensure that the selected optical markers are anisotropic, facilitating matching with the positioning and navigation system and improving navigation accuracy.

[0019] In some embodiments, the first frame, the second frame, and the third frame each include at least four frame edges, each enclosing a surgical area of ​​different sizes. The four frame edges are connected end-to-end, and the lengths of the four frame edges are all different.

[0020] In the above implementation process, the first frame, the second frame, and the third frame each include at least four frame sides, which are connected end to end, making the first frame, the second frame, and the third frame quadrilateral structures of different sizes, suitable for different surgical areas, providing doctors with more surgical options. Doctors can select the appropriate frame or combine multiple frames according to the size of the patient's surgical incision, thereby improving the positioning accuracy of the surgical incision and the tissue under the surgical incision, and ensuring the success rate of the surgery.

[0021] For example, the first frame, the second frame, and the third frame can also be pentagons, hexagons, etc., and the length of each side of the other polygons is different.

[0022] For example, the second frame is provided with a plurality of snap-fit ​​components facing the first frame. The snap-fit ​​components are respectively provided on the frame edge of the second frame. The snap-fit ​​components have a slot that is adapted to the frame edge of the first frame. The frame edge of the first frame is inserted into the slot, thereby making the first frame and the second frame detachably connected, which facilitates the connection and separation of the first frame and the second frame. Of course, the snap-fit ​​components can also be provided on the first frame.

[0023] In addition, by setting up a snap-fit ​​connector, the first frame and the second frame are connected. When both the first frame and the second frame are attached to the patient's skin, they can provide real-time feedback of dynamic changes to the positioning and navigation system in response to the patient's physiological movements, thereby improving the positioning accuracy of the surgical incision and the tissue under the surgical incision.

[0024] For example, the connection method between the second frame and the third frame is the same as the connection method between the second frame and the first frame. Of course, the snap-fit ​​component can also be set on the third frame or on the second frame, which will not be elaborated here.

[0025] For example, the outer periphery of the second frame has multiple protrusions, and the corresponding position of the first frame has a groove. The protrusions are inserted into the grooves to connect the first frame and the second frame. Alternatively, the second frame has a groove, and the first frame has protrusions. The connection method is the same as described above. The connection method between the third frame and the second frame is also the same as described above, and will not be repeated here.

[0026] For example, each edge of the first frame is provided with a groove. When the second frame is connected to the first frame, the four vertices of the second frame are inserted into the grooves to achieve the connection between the second frame and the first frame, which is convenient for operation. The connection method between the third frame and the second frame is the same as described above.

[0027] In some embodiments, the lengths of at least four of the frame sides of the first frame, the second frame, and the third frame are all different.

[0028] In the above implementation process, the length of each side of the first frame, the second frame and the third frame are different. In this way, an optical mark is arbitrarily selected on each frame side, making it easier for the selected optical mark to meet anisotropy. When matched with the positioning and navigation system, the positioning accuracy of the surgical incision and the tissue under the surgical incision is more accurate.

[0029] In some embodiments, the optical marker is used to be electrically connected to an external power source and is adapted to emit light for tracking and identification by the positioning and navigation system; or, the optical marker is adapted to reflect light for tracking and identification by the positioning and navigation system.

[0030] In the above implementation process, the optical marker can be an infrared light emitting device or a light-emitting diode. The optical marker is electrically connected to an external power source, which provides power to the optical marker. The optical marker is used to actively emit infrared light to the positioning and navigation system, making it suitable for being tracked and identified by the positioning and navigation system to locate the surgical incision. Alternatively, the optical marker can be a passive reflective sphere coated with phosphor, which is suitable for reflecting light to the positioning and navigation system.

[0031] For example, when using optical markers to actively emit light, the tracer can be connected to an external power source, which provides power to the device. The doctor selects at least four optical markers to emit light to the positioning and navigation system, thereby locating the surgical incision and the tissue beneath it. When using optical markers to reflect light, the doctor directly places reflective spheres at at least four selected locations, causing the four reflective spheres to emit light to the positioning and navigation system, thereby locating the surgical incision and the tissue beneath it.

[0032] For example, the tracer also includes a power connection cable, one end of which is connected to an external power source and the other end is electrically connected to the optical mark. When the optical mark needs to actively emit light, the power connection cable is connected to the external power source to provide power to the optical mark.

[0033] For example, the first frame, the second frame, and the third frame are all equipped with wires and power connection lines. When one frame is selected, the selected frame is connected to an external power source; when multiple frames are selected, each frame needs to be connected to an external power source.

[0034] In some embodiments, the tracer further includes a power source and a wire with one end electrically connected to the power source, and the power source is provided with a power switch, the other end of the wire being connected to the optical marker, and the power switch being used to control the power source to be turned on or off.

[0035] In the above implementation process, the tracer includes a power supply and a power switch. The power switch is used to control the power supply. When needed, the power switch is turned on, and the power supply provides power to the optical marker through the wires, so that the tracer can be self-powered, which is suitable for situations where there is a lack of external power in the surgical environment and improves the applicability of the product.

[0036] For example, the first frame, the second frame, and the third frame are all equipped with a power supply and a power switch. The power supply is connected to a wire and is used to provide electrical energy to the optical marker. The power switch is used to control the power supply. When the optical marker needs to actively emit light, the power switch is turned on; when the operation is completed, the power switch is turned off.

[0037] In some embodiments, the positioning and navigation system includes an infrared navigation system, wherein the optical marker is adapted to emit or reflect infrared light.

[0038] In the above implementation process, an infrared navigation system is used. Optical markers emit or reflect infrared light, and the infrared navigation system identifies and tracks in real time to determine the patient's surgical incision and the tissue under the surgical incision. In addition, when the patient is making physiological movements, the tracker is attached to the patient's skin, and the optical markers can emit or reflect infrared light in real time during the patient's physiological movements, which facilitates real-time tracking and identification by the infrared navigation system.

[0039] In some embodiments, the tracer is a flexible element.

[0040] In the above implementation process, the tracer is set as a flexible component, which makes it easier for the tracer to fit the patient's skin. The material of the tracer can be polyetheretherketone special engineering plastic or silicone. These materials are mainly biocompatible materials, not easily deformed, easy to disinfect, and do not show up under the scanning of the intraoperative imaging equipment, thereby reducing the artifacts in the navigation image.

[0041] The technical solution of this application has the following effects:

[0042] 1. The tracker is designed to fit snugly against the patient's skin. It includes a tracking frame that surrounds the surgical incision. Multiple optical markers on the tracker are tracked and identified by the positioning and navigation system, thereby locating the surgical incision and the tissue beneath it. This eliminates the need for additional incisions outside the original surgical area for installing positioning aids, avoiding additional surgical trauma. The surgery can be completed through a single incision, improving patient safety and surgical precision. Furthermore, the tracker's contact with the patient's skin allows for real-time detection and feedback of dynamic changes during the procedure, further enhancing surgical accuracy.

[0043] 2. The tracer consists of multiple detachable and interconnectable first, second, and third frames. Doctors can select the appropriate frame to fit onto the patient's skin surface based on the length of the surgical incision, providing more operational options for the surgery. Attached Figure Description

[0044] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments of this application will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0045] Figure 1 This is a schematic diagram of the structure of the non-invasive tracer provided in the embodiments of this application;

[0046] Figure 2 This is a schematic diagram of the structure of the non-invasive tracer provided in the embodiments of this application;

[0047] Figure 3 A structural schematic diagram illustrating one connection method of the first frame, second frame, and third frame provided in an embodiment of this application;

[0048] Figure 4 This is a structural schematic diagram illustrating another connection method for the first frame, second frame, and third frame provided in an embodiment of this application.

[0049] Icons: 1-Tracer; 2-First frame; 3-Second frame; 4-Third frame; 5-Optical marker; 6-Patient skin; 7-Surgical incision; 8-Snap-fit ​​connector. Detailed Implementation

[0050] The technical solutions in the embodiments of this application will now be described with reference to the accompanying drawings.

[0051] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. Furthermore, in the description of this application, terms such as "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0052] like Figures 1 to 4 As shown, this application provides a non-invasive assisted positioning device, including: a positioning and navigation system; a tracer 1, which is used to fit against the patient's skin 6 and includes a tracer frame for surrounding the patient's surgical incision 7. The tracer frame is provided with a plurality of optical marks 5, which are suitable for being tracked and identified by the positioning and navigation system to locate the surgical incision 7 and the tissue below the surgical incision 7.

[0053] In the above-described process, during surgery, the tracer 1 is attached to the patient's skin 6. The tracer 1 includes a tracer frame that surrounds the surgical incision 7 on the patient's skin 6. Multiple optical markers 5 on the tracer frame are matched with a positioning and navigation system. The positioning and navigation system tracks and identifies the multiple optical markers 5 to locate the surgical incision 7 and the tissue beneath it. This eliminates the need for a separate surgical incision 7 near the surgical incision 7 to fix the tracer 1 during surgery. The tracer 1 is directly attached to the surface of the patient's skin 6 and matched with the positioning and navigation system, thereby reducing patient pain. In addition, with the tracer 1 attached to the surface of the patient's skin 6, the tracer 1 can effectively monitor and provide feedback on dynamic changes during surgery in real time when the patient performs physiological movements, such as breathing or intestinal peristalsis, thereby improving surgical precision.

[0054] In some embodiments, the tracer frame includes a first frame 2 for fitting against the patient's skin 6, and a plurality of optical markers 5 are provided on the first frame 2, the plurality of optical markers 5 being spaced apart.

[0055] In the above implementation process, the tracking frame includes a first frame 2, which is attached to the surface of the patient's skin 6. The surgical incision 7 is located within the first frame 2. The first frame 2 is provided with multiple optical markers 5, which are spaced apart. At least four optical markers 5 are selected to match the positioning and navigation system. The positioning and navigation system tracks and identifies the surgical incision 7 and the tissue beneath it, thereby locating the surgical incision 7.

[0056] For example, at least four optical marks 5 are selected and are anisotropically distributed on the first frame, wherein the anisotropic distribution means that the positional distribution of the four or more optical marks 5 on one side of the first frame is not symmetrical, and the length of the line connecting each pair of optical marks 5 is different.

[0057] like Figure 2 As shown, in some embodiments, the tracer frame further includes a second frame 3 for fitting against the patient's skin 6. The second frame 3 is located inside the first frame 2 and is detachably connected to the first frame 2. A plurality of optical markers 5 are spaced apart on the second frame 3.

[0058] In the above implementation process, the area of ​​the second frame 3 is smaller than that of the first frame 2. In addition, the first frame 2 and the second frame 3 are detachably connected. Through the above settings, the doctor can select a suitable frame according to the size of the patient's surgical incision 7. The optical marker 5 is matched with the positioning and navigation system to locate the surgical incision 7 and the tissue under the surgical incision 7, thereby improving the surgical accuracy and providing more operable solutions for the surgery.

[0059] For example, if the length of the surgical incision 7 is greater than the length of the diagonal of the second frame 3, it means that the second frame 3 cannot enclose the surgical incision 7 within the second frame 3. In this case, the doctor needs to attach the first frame 2 to the surface of the patient's skin 6 so that the surgical incision 7 is located within the first frame 2. At least four optical markers 5 are selected on the first frame 2 to match the positioning and navigation system, thereby locating the surgical incision 7 and the tissue under the surgical incision 7 and improving the positioning accuracy.

[0060] If the length of the surgical incision 7 is less than the length of the diagonal of the second frame 3, the doctor can attach the second frame 3 to the surface of the patient's skin 6, so that the surgical incision 7 is located inside the second frame 3. At least four optical markers 5 on the second frame 3 are selected to match the positioning and navigation system, thereby locating the surgical incision 7 and the tissue under the surgical incision 7. Alternatively, the first frame 2 can be attached to the patient's skin 6, and the optical markers 5 on the first frame 2 can be matched with the positioning and navigation system. Understandably, when the doctor uses the first frame 2 or the second frame 3, since the area of ​​the second frame 3 is smaller than that of the first frame 2, the positioning accuracy of the second frame 3 is better than that of the first frame 2.

[0061] Of course, since the second frame 3 is detachably connected to the first frame 2, the surgeon can also connect the first frame 2 and the second frame 3 together and attach them to the patient's skin 6, so that the surgical incision 7 is located within the second frame 3. Optical markers 5 are selected on the first frame 2 and the second frame 3 respectively. The number of selected optical markers 5 is at least four, and they are anisotropic, matching the positioning and navigation system, thereby locating the surgical incision 7 and the tissue beneath it. For example, two can be selected on the first frame 2 and two on the second frame 3, or one can be selected on the first frame 2 and three on the second frame 3. Using two frames makes it easier for the selected optical markers 5 to match with the positioning and navigation system, thereby improving matching efficiency and reducing surgical operation time. In addition, using two frames also provides more operational options for the surgery, ensuring its smooth progress.

[0062] In some embodiments, the tracer frame further includes a third frame 4 for fitting against the patient's skin 6. The third frame 4 is located inside the second frame 3 and is detachably connected to the second frame 3. A plurality of optical markers 5 are spaced apart on the third frame 4.

[0063] In the above implementation process, the area of ​​the third frame 4 is smaller than that of the second frame 3. In addition, the third frame 4 and the second frame 3 are detachably connected. Through the above settings, the doctor can select a suitable frame according to the size of the patient's surgical incision 7. The optical marker 5 is matched with the positioning and navigation system to locate the surgical incision 7 and the tissue under the surgical incision 7, thereby improving the accuracy of the surgery.

[0064] like Figure 1 As shown, for example, if the length of the surgical incision 7 is less than the length of the diagonal of the third frame 4, the doctor can choose to use a frame based on the length of the patient's surgical incision 7. For example, the doctor can attach the third frame 4 to the surface of the patient's skin 6 so that the surgical incision 7 is located inside the third frame 4. At least four optical markers 5 are selected on the third frame 4 to match the positioning and navigation system, thereby locating the surgical incision 7 and the tissue under the surgical incision 7. Alternatively, the second frame 3 or the first frame 2 can be attached to the surface of the patient's skin 6, providing the doctor with more options. When using one of the frames, the positioning accuracy of the third frame 4 is better than that of the second frame 3 and the first frame 2.

[0065] Of course, when the length of the surgical incision 7 is less than the length of the diagonal of the third frame 4, the doctor can also choose to connect two frames or three frames to each other, all of which are attached to the surface of the patient's skin 6. For example, the second frame 3 can be connected to the first frame 2, and at least four optical marks 5 can be selected on the first frame 2 and the second frame 3 to match the positioning and navigation system to locate the surgical incision 7 and the tissue under the surgical incision 7; or the second frame 3 can be connected to the third frame 4, and at least four optical marks 5 can be selected on the third frame 4 and the second frame 3 to match the positioning and navigation system to locate the surgical incision 7 and the tissue under the surgical incision 7.

[0066] like Figure 3 and Figure 4 As shown, the third frame 4, the second frame 3, and the first frame 2 can be connected to each other and all attached to the surface of the patient's skin 6. At least four optical markers 5 can be selected on the third frame 4, the second frame 3, and the first frame 2. Through the above settings, more options can be provided to the doctor. At the same time, when multiple frames are selected, it is easier to make the selected optical markers 5 anisotropic, which is convenient for matching with the positioning and navigation system and can also improve the accuracy of navigation.

[0067] In some embodiments, the first frame 2, the second frame 3, and the third frame 4 each include at least four frame edges, which respectively enclose surgical areas of different sizes. The four frame edges are connected end to end, and the lengths of the four frame edges are all different.

[0068] In the above implementation process, the first frame 2, the second frame 3, and the third frame 4 each include at least four frame sides, which are connected end to end, making the first frame 2, the second frame 3, and the third frame 4 quadrilateral structures of different sizes, suitable for different surgical areas, providing doctors with more surgical options. Doctors can select the appropriate frame or combine multiple frames according to the size of the patient's surgical incision 7, thereby improving the positioning accuracy of the surgical incision 7 and the tissue under the surgical incision 7, and ensuring the success rate of the surgery.

[0069] For example, the first frame 2, the second frame 3, and the third frame 4 can also be pentagons, hexagons, etc., and the length of each side of the other polygons is different.

[0070] like Figure 3 As shown, for example, the second frame 3 is provided with a plurality of snap-fit ​​pieces 8 facing the first frame 2. The plurality of snap-fit ​​pieces 8 are respectively provided on the frame edge of the second frame 3. The snap-fit ​​pieces 8 have snap-fit ​​slots that are adapted to the frame edge of the first frame 2. The frame edge of the first frame 2 is inserted into the snap-fit ​​slots, thereby making the first frame 2 and the second frame 3 detachably connected, which facilitates the connection and separation of the first frame 2 and the second frame 3. Of course, the snap-fit ​​pieces 8 can also be provided on the first frame 2.

[0071] In addition, by setting the snap-fit ​​connector 8, the first frame 2 and the second frame 3 are connected. When both the first frame 2 and the second frame 3 are attached to the patient's skin 6, they can provide real-time feedback of dynamic changes to the positioning and navigation system in accordance with the patient's physiological movements, thereby improving the positioning accuracy of the surgical incision 7 and the tissue under the surgical incision 7.

[0072] For example, the connection method between the second frame 3 and the third frame 4 is the same as the connection method between the second frame 3 and the first frame 2. Of course, the snap-fit ​​8 can also be set on the third frame 4 or on the second frame 3, which will not be described in detail here.

[0073] For example, the outer periphery of the second frame 3 is provided with multiple protrusions, and the corresponding position of the first frame 2 is provided with a groove. The protrusions are inserted into the grooves to connect the first frame 2 and the second frame 3. Alternatively, the second frame 3 is provided with a groove, and the first frame 2 is provided with protrusions. The connection method is the same as described above. The connection method between the third frame 4 and the second frame 3 is the same as described above, and will not be repeated here.

[0074] For example, each edge of the first frame 2 is provided with a groove. When the second frame 3 is connected to the first frame 2, the four vertices of the second frame 3 are inserted into the grooves to achieve the connection between the second frame 3 and the first frame 2, which is convenient for operation. The connection method between the third frame 4 and the second frame 3 is the same as described above.

[0075] In some embodiments, the lengths of at least four sides of the first frame 2, the second frame 3, and the third frame 4 are all different.

[0076] In the above implementation process, the length of each frame side of the first frame 2, the second frame 3 and the third frame 4 is different. Thus, by arbitrarily selecting an optical mark 5 on each frame side, the selected optical mark 5 is more likely to satisfy anisotropy. When matched with the positioning and navigation system, the positioning accuracy of the surgical incision 7 and the tissue under the surgical incision 7 is more accurate.

[0077] In some embodiments, the optical marker 5 is used to be electrically connected to an external power source and is adapted to emit light for tracking and identification by a positioning and navigation system; or, the optical marker 5 is adapted to reflect light for tracking and identification by a positioning and navigation system.

[0078] In the above implementation process, the optical marker 5 can be an infrared light emitting device or a light-emitting diode. The optical marker 5 is electrically connected to an external power supply, which provides power to the optical marker 5. The optical marker 5 is used to actively emit infrared light to the positioning and navigation system, which is suitable for being tracked and identified by the positioning and navigation system to locate the surgical incision 7 and the tissue under the surgical incision 7. The optical marker 5 can also be a passive reflective sphere coated with fluorescent powder, which is suitable for reflecting light to the positioning and navigation system.

[0079] For example, when the optical marker 5 actively emits light, the tracer 1 can be connected to an external power source, which provides power to the tracer. The doctor selects at least four optical markers 5 to emit light to the positioning and navigation system to locate the surgical incision 7 and the tissue under the surgical incision 7. When the optical marker 5 is used to reflect light, the doctor directly places reflective spheres at at least four selected locations, so that the four reflective spheres emit light to the positioning and navigation system, thereby locating the surgical incision 7 and the tissue under the surgical incision 7.

[0080] For example, the tracer 1 also includes a power connection cable, one end of which is connected to an external power source and the other end is electrically connected to the optical mark 5. When the optical mark 5 needs to actively emit light, the power connection cable is connected to the external power source to provide power to the optical mark 5.

[0081] For example, wires and power connection lines are provided in the first frame 2, the second frame 3 and the third frame 4. When one frame is selected, the selected frame is connected to an external power source; when multiple frames are selected, each frame needs to be connected to an external power source.

[0082] In some embodiments, the tracer 1 further includes a power supply and a wire with one end electrically connected to the power supply, and the power supply is equipped with a power switch. The other end of the wire is connected to the optical marker 5, and the power switch is used to control the power supply to be turned on or off.

[0083] In the above implementation process, the tracer 1 includes a power supply and a power switch. The power switch is used to control the power supply. When it is needed, the power switch is turned on, and the power supply provides power to the optical marker 5 through the wire, so that the tracer 1 can be self-powered, which is suitable for situations where there is a lack of external power in the surgical environment and improves the applicability of the product.

[0084] For example, the first frame 2, the second frame 3 and the third frame 4 are all equipped with a power supply and a power switch. The power supply is connected to a wire. The power supply is used to provide electrical energy to the optical marker 5. The power switch is used to control the power supply. When the optical marker 5 needs to actively emit light, the power switch is turned on; when the operation is over, the power switch is turned off.

[0085] In some embodiments, the positioning and navigation system includes an infrared navigation system, wherein the optical marker 5 is adapted to emit or reflect infrared light.

[0086] In the above implementation process, an infrared navigation system is used. The optical marker 5 emits or reflects infrared light, and the infrared navigation system identifies and tracks in real time to determine the patient's surgical incision 7 and the tissue under the surgical incision 7. In addition, when the patient is making physiological movements, the tracer 1 is attached to the patient's skin 6, and the optical marker 5 can emit or reflect infrared light in real time when the patient is making physiological movements, which facilitates the real-time tracking and identification of the infrared navigation system.

[0087] In some embodiments, the tracer 1 is a flexible element.

[0088] In the above implementation process, the tracer 1 is set as a flexible part, which makes it easier for the tracer 1 to fit into the patient's skin. The material of the tracer 1 can be polyetheretherketone special engineering plastic or silicone. These materials are mainly biocompatible materials, not easily deformed, easy to disinfect, and do not show up under the scanning of the intraoperative imaging equipment, thereby reducing the artifacts of the navigation image.

[0089] The above description is merely an embodiment of this application and is not intended to limit the scope of protection of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

[0090] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

[0091] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

Claims

1. A non-invasive assisted positioning device, characterized in that, include: Positioning and navigation system; A tracer for contact with a patient’s skin, comprising a tracer frame for surrounding a surgical incision, the tracer frame having a plurality of optical markers adapted to be tracked and identified by the positioning and navigation system for locating the surgical incision and the tissue beneath it. The tracer frame includes a first frame for fitting against the patient's skin, and the first frame is provided with a plurality of optical markers, which are spaced apart. The tracer frame further includes a second frame for conforming to the patient's skin. The second frame is located inside the first frame and is detachably connected to the first frame. A plurality of optical marks are spaced apart on the second frame. Optical marks are selected on the first frame and the second frame respectively. The number of selected optical marks is at least four and they are anisotropic, for matching with the positioning and navigation system.

2. The non-invasive assisted positioning device according to claim 1, characterized in that, The tracer frame also includes a third frame for adhering to the patient's skin. The third frame is located inside the second frame and is detachably connected to the second frame. The third frame is provided with a plurality of optical marks at intervals.

3. The non-invasive assisted positioning device according to claim 2, characterized in that, The first frame, the second frame, and the third frame each include at least four frame sides, and each encloses a surgical area of ​​different sizes.

4. The non-invasive assisted positioning device according to claim 3, characterized in that, The lengths of at least four of the frame sides of the first frame, the second frame, and the third frame are all different.

5. The non-invasive assisted positioning device according to any one of claims 1 to 4, characterized in that, The optical marker is used for electrical connection to an external power source and is adapted to emit light for tracking and identification by the positioning and navigation system.

6. The non-invasive assisted positioning device according to any one of claims 1 to 4, characterized in that, The tracer also includes a power supply and a wire connected to the power supply at one end. The power supply is equipped with a power switch, and the other end of the wire is connected to the optical mark. The power switch is used to control the power supply to be turned on or off.

7. The non-invasive assisted positioning device according to any one of claims 1 to 4, characterized in that, The positioning and navigation system includes an infrared navigation system, and the optical markers are adapted to emit or reflect infrared light.

8. The non-invasive assisted positioning device according to any one of claims 1 to 4, characterized in that, The tracer is a flexible component.

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