Marker device, surgical navigation system including it, and method of navigation using it.

Abstract

This invention relates to a marker device for a surgical navigation system, the marker device comprising: a marker body (1), a plurality of reflective spheres (2) disposed in the marker body, and a plurality of supports (3) for mounting reflective spheres. The marker body (1) has an upper side provided with the plurality of supports (3) and a lower side opposite to the upper side, wherein at least one reflective sphere (2) is disposed on the upper side and the lower side of the marker body (1), such that the reflective sphere disposed on the upper side of the marker body (1) and the reflective sphere disposed on the lower side of the marker body (1) are spatially offset relative to each other. The invention also relates to a surgical navigation system including the marker device and a method of navigation using the marker device.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical equipment, in particular to a surgical navigation system, and more particularly to a marker device for a surgical navigation system and a method for registration of a surgical navigation system using the same. BACKGROUND

[0002] It is known to take images of a patient using an imaging device, for example comprising a two-dimensional C-arm, a three-dimensional C-arm or an O-arm. These imaging devices can take images of a treatment site of a patient intraoperatively in order to register a surgical navigation system to guide a surgical operation.

[0003] There are many types of imaging devices available on the market today, with various configurations. However, some of the imaging devices do not have a tracker installed on the gantry, or cannot have a tracker installed on the gantry, resulting in the inability to be recognized and directly used in a surgical navigation system.

[0004] In addition, some imaging devices support the connection of additional trackers using a specific installation method, but the physical parameters of the additional trackers and the existing trackers on the gantry are not necessarily the same, and the underlying connection protocols also differ, so they are not universal. At the same time, due to repeated installation and repeated calibration, the accuracy and operational convenience of the navigation system are reduced. Therefore, even for devices with existing trackers, they need to be matched with each other. However, if each tracker from a different manufacturer is paired one by one, it will take a considerable amount of time and effort.

[0005] Therefore, there is a need for a universal solution to solve the above problems. SUMMARY

[0006] One object of the present application aims to solve one of the above problems and defects in the prior art.

[0007] According to one aspect of the present application, a marker device for a surgical navigation system is provided, comprising a marker body, a plurality of radiopaque spheres arranged in the marker body, and a plurality of supports for mounting reflective spheres. The marker body has an upper side provided with the plurality of supports and a lower side opposite to the upper side, wherein at least one radiopaque sphere is arranged on the upper side and the lower side of the marker body, respectively, such that the radiopaque spheres arranged on the upper side and the radiopaque spheres arranged on the lower side of the marker body are spatially offset relative to each other.

[0008] Optionally, the marker body has a star-shaped flat plate configuration as a whole.

[0009] Optionally, the plurality of supports are irregularly arranged on the marker body, such that when the reflective spheres are mounted on the corresponding supports, at least two reflective spheres are spatially offset relative to each other.

[0010] Optionally, the marker device further comprises a plurality of holding structures extending from a surface of the marker body, the holding structures being respectively configured to position and hold a support at an end of the holding structure opposite to the surface of the marker body, wherein at least two of the holding structures are configured to extend different distances relative to the surface of the marker body, such that the respective supports at the ends of the at least two holding structures form a height difference.

[0011] Optionally, the tip end of each support has a circumferential groove for tightly fitting with the reflective ball to fixedly mount the reflective ball on the respective support.

[0012] Optionally, the marker body further comprises an extension structure extending a distance from a surface of the marker body, and at least one of the reflective balls is located at an end of the extension structure distal to the surface of the marker body.

[0013] Optionally, the marker body further comprises one or more of the following:

[0014] 1) a semi-spherical wall portion for enclosing and holding the reflective balls;

[0015] 2) a connection hole by means of which the marker device is fixedly connectable to an external connection member using a connection member cooperating with the connection hole;

[0016] 3) an identification arrow located on an upper surface of the marker body for indicating an orientation of the marker device in use, and

[0017] 4) a positioning member for positioning the marker device relative to the external connection member and preventing relative rotation therebetween when the marker device is fixedly connected to the external connection member.

[0018] Optionally, the marker body is made of a X-ray transparent polymer material by an injection molding process, the reflective balls are fixed in the marker body by an injection molding insert process, the supports are fixed in the marker body by an injection molding insert process, the connection hole is integrally formed in a tab portion extending from a side edge of the marker body by an injection molding process, the identification arrow is integrally formed on an upper surface of the marker body by an injection molding process, and / or the positioning member is integrally formed on the marker body by an injection molding process.

[0019] Optionally, there are two positioning members oppositely arranged relative to each other around the connection hole.

[0020] According to another aspect of the present application, there is provided a surgical navigation system comprising the aforementioned marker device.

[0021] According to another aspect of the present invention, a method for navigation using the aforementioned marker device is provided, the method comprising the following steps:

[0022] A) Secure the marker device to the surgical area or its vicinity;

[0023] B) Track the reflective ball installed on the marker device using an optical tracking device to obtain the position of the reflective ball;

[0024] C) After or during step B), the surgical area is scanned using an imaging device to obtain an image, wherein the imaging ball of the marker device is visualized in the image;

[0025] D) Establish the spatial relationship between the surgical area and the acquired images; and

[0026] E) Establish the spatial relationship between the surgical area and the surgical navigation system.

[0027] Optionally, in step E), the spatial relationship between the surgical area and the surgical navigation system is established based on the relative positions of the imaging ball and the reflective ball in the marker device.

[0028] The marker device according to the present invention has the following advantages: simple manufacturing process; regular and beautiful overall shape; arrangement of imaging balls forming a certain height difference, and the reflective balls can also form a height difference after installation; stable and durable structure; fast and accurate registration; wide applicability; convenient and stable connection with external connectors; suitable for registration with 3D surgical navigation systems from different manufacturers. Attached Figure Description

[0029] The invention will now be described in detail with reference to the accompanying drawings, which are non-limiting embodiments. The drawings are merely illustrative and not necessarily drawn to scale. Furthermore, they show only those parts necessary to illustrate the invention, while other parts may be omitted or simply mentioned. That is, the invention may include other parts besides those shown in the drawings. In the drawings:

[0030] Figure 1 This is a schematic top perspective view of a marker device according to an embodiment of the present invention;

[0031] Figure 2 yes Figure 1 A schematic bottom-view perspective view of the marker device shown;

[0032] Figure 3 yes Figure 1 A schematic front view of the marker device shown;

[0033] Figure 4 yes Figure 1A schematic cross-sectional view of the marker device shown. Detailed Implementation

[0034] The marker device for a surgical navigation system according to an embodiment of the present invention is described below with reference to the accompanying drawings. In the following description, numerous specific details are set forth to enable those skilled in the art to more fully understand the invention. However, it will be apparent to those skilled in the art that implementation of the invention may not include some of these specific details. Furthermore, it should be understood that the invention is not limited to the specific embodiments described. Rather, the invention can be conceived to be practiced with any combination of the following features and elements, regardless of whether they relate to different embodiments. Therefore, the following aspects, features, embodiments, and advantages are illustrative only and should not be construed as elements or limitations of the claims unless expressly set forth in the claims.

[0035] In this document, "upper" and "lower" refer to the relative spatial positional relationship along the y-axis of the coordinate system shown. However, the aforementioned coordinate system does not constitute a limitation on the present invention. Those skilled in the art will understand that the marking device can be arranged arbitrarily as needed during use.

[0036] Figure 1 A marker device for a surgical navigation system according to an embodiment of the present invention is schematically illustrated. The marker device includes a marker body 1 and a plurality of radiopaque spheres 2 disposed within the marker body (see [reference]). Figure 4 ), and multiple support members 3 for mounting the reflective ball (not shown).

[0037] like Figure 1 and Figure 2 As shown, the marker body 1 can be a flat, star-shaped (e.g., quadrangular star) plate. Therefore, the bottom of the marker device is relatively flat and can be directly attached to the patient's skin.

[0038] The marker body 1 can be made of an X-ray transparent polymer material through injection molding. However, the manufacture of the marker body according to the present invention is not limited to this method.

[0039] like Figure 3 As best shown, in this embodiment, the marker body 1 may have an upper side and a lower side opposite to the upper side, wherein a plurality of support members 3 are disposed on the upper side of the marker body 1.

[0040] See Figure 4 At least one developing ball 2 is arranged on the upper and lower sides of the marker body 1, such that the developing ball 2 arranged on the upper side of the marker body 1 and the developing ball 2 arranged on the lower side of the marker body 1 are spatially offset relative to each other, for example, forming a height difference in the vertical direction as shown by the y-axis.

[0041] Optionally, the developing ball 2 arranged on the upper side of the marker body 1 and the developing ball 2 arranged on the lower side of the marker body 1 may also be offset relative to each other in the horizontal direction as shown by the x-axis.

[0042] In an exemplary labeling device, a total of 7 developing balls 2 are included, of which 5 developing balls 2 are distributed on the lower side of the labeling body 1, and the other 2 developing balls 2 are distributed on the upper side of the labeling body 1, as shown below. Figure 1 and Figure 2 As shown, the developing sphere 2 is surrounded by a hemispherical wall portion 11, which will be described in detail below.

[0043] The size, number, and distribution rules of the imaging spheres 2 can be specifically designed according to the specific algorithm. The material of the imaging spheres 2 only needs to meet the requirement of being able to be developed in medical imaging equipment.

[0044] All developing balls 2 in the marker device can have the same diameter.

[0045] See Figure 1 , Figure 2 and Figure 4 The marker body 1 may also include a hemispherical wall portion 11 for surrounding and holding the developing ball 2. The developing ball 2 can be fixed in the marker body 1 by injection molding insert, and the hemispherical wall portion 11 located on the marker body 1 facilitates the accurate positioning of the developing ball 2 during the injection molding insert process.

[0046] like Figure 3 As shown, at least one hemispherical wall portion 11 may be arranged at an extension structure 15 extending a distance from the surface of the marker body, such that the developing sphere 2 surrounded by the hemispherical wall portion 11 is arranged to be spatially spaced further apart from the developing sphere 2 located on the opposite side, especially in the vertical direction as shown by the y-axis.

[0047] Furthermore, the marker body 1 may also include a connecting hole 12, such as a threaded hole. Thus, the marker device can be fixedly connected to an external connector via the connecting hole 12 and using a connecting member, such as a threaded member (not shown), that mates with the connecting hole. The connecting member can be a bolt. The connecting hole 12 can be integrally molded in approximately the center of the marker body 1 using an injection molding process, such that the central axis of the connecting hole 12 can be positioned at the center of gravity of the marker body 1.

[0048] However, the connection method between the marking device of the present invention and the external connector is not limited to threaded connection, but may also be snap-fit ​​connection or adhesion by tape, etc.

[0049] In addition, the marker body 1 may also include a positioning member 14. Figure 1In the illustrated embodiment, the positioning member 14 is configured as a positioning post. Advantageously, two positioning members 14 are arranged opposite to each other around the connecting hole 12. When the marking device is fixedly connected to the external connector, the positioning members 14 can be used to position the marking device relative to the external connector and prevent relative rotation between the two. For this purpose, the external connector can be provided with corresponding slots that mate with the positioning members 14. The positioning members 14 can be integrally molded onto the marking body 1 by injection molding.

[0050] External connectors can be adhesives (such as tape), universal arms, or other specially designed connectors, as long as they can securely position the marker device in the surgical area and / or the patient's surgical site.

[0051] See Figure 1 Multiple (four in this embodiment) support members 3 are irregularly distributed around the outer periphery of the marker body 1, such that when the reflective ball is installed on the corresponding support member 3, at least two reflective balls are spatially offset relative to each other.

[0052] Specifically, in this embodiment, the marker device according to the present invention may further include a plurality of retaining structures 10 extending from the surface (preferably the upper surface) of the marker body 1 (see...). Figure 1 and Figure 2 The retaining structure 10 can respectively position and hold the support 3 at the end of the retaining structure 10 opposite to the surface of the marker body 1. At least two retaining structures 10 can be configured to extend different distances relative to the surface of the marker body 1, such that the corresponding support 3 at their ends form a height difference.

[0053] Therefore, when reflective balls are installed on the marker device, multiple reflective balls can be irregularly distributed in the space where the marker body 1 is located, which is beneficial for being identified by the optical tracking system.

[0054] The support member 3 is made of a material that is X-ray transparent or has minimal artifacts under X-ray (e.g., metal), and is fixed to the marker body 1 by an injection molding insert process. During manufacturing, metal components (such as metal preforms or blanks) are injection molded into the marker body to form the support member 3. When using the marker device, the reflective ball can be inserted into the support member 3, and after use, the reflective ball can be removed. Therefore, the marker device according to the present invention is not only more durable and less prone to deformation, but also allows for more convenient installation and removal of the reflective ball.

[0055] In this embodiment, the support member 3 is constructed in the form of a pillar. For example... Figure 3 and Figure 4As shown, the tip of each support member 3 may have a circumferential groove 31. The circumferential groove 31 can be used to fit tightly with the reflective ball so that the reflective ball is fixedly mounted on the corresponding support member 3. After being inserted into the support member 3, the reflective ball can fit tightly with the support member 3.

[0056] However, the installation method of the reflective ball is not limited to this. For example, it can be envisioned that the support member 3 has external threads, and the reflective ball has corresponding internal threads, so that the reflective ball can be fixedly connected to the support member 3 by screwing.

[0057] In addition, the marker body 1 may also include an identification arrow 13. The identification arrow 13 is disposed on the upper surface of the marker body 1 and is used to indicate the orientation of the marker device during use.

[0058] For example, the marker arrow 13 can point to the side where the support member 3, which has a shorter extension distance from the surface of the marker body 1 and is therefore shorter in height, is located. This makes the side where the support member 3, which has a shorter height, is closer to the external optical tracking device compared to the side where the support member 3, which has a greater height, is located. Therefore, the installed reflective ball is less likely to be obstructed, making it more easily identifiable by the optical tracking system.

[0059] The marker device according to the present invention has a robust structure that is not easily deformed, which also results in less positional variation and more precise positioning of the developing ball and the mounted reflective ball.

[0060] When using the marker device according to the invention for surgical navigation, a method comprising the following steps can be performed:

[0061] Step A): Secure the marker device to the surgical area (including the patient's surgical site) or its vicinity;

[0062] Step B): Track the reflective ball installed on the marker device using an optical tracking device to obtain the position of the reflective ball;

[0063] Step C): After or simultaneously with step B), the surgical area is scanned using an imaging device to obtain an image, wherein the imaging ball of the marker device is visualized in the image;

[0064] Step D): Establish the spatial relationship between the surgical area and the acquired images; and

[0065] Step E): Establish the spatial relationship between the surgical area and the patient's surgical site and the surgical navigation system.

[0066] In step E), the spatial relationship between the surgical area and the surgical navigation system can be established based on the relative positions of the imaging ball and the reflective ball in the marker device.

[0067] Industrial applicability

[0068] During navigation surgery, the corresponding external reflective ball is first installed onto the support member 3 (i.e., the column) on the marker body 1, making the reflective ball and the marker device a whole. Then, the external connecting member (e.g., the connecting rod) is positioned and connected to the marker device through the positioning member 14 on the marker body 1. Then, the external bolts are used to lock and fix the marker device to the external connecting rod through the threaded connection hole 12 on the marker body 1, and the whole device is fixed in the surgical area (e.g., above the patient's surgical site). The marking arrow on the marker device is pointed to the external optical tracking device (especially the camera of the optical tracking device). After intraoperative image scanning and the optical tracking device's recognition of the marker device, the spatial positional relationship between the surgical area and the patient's intraoperative image, as well as the spatial positional relationship between the patient's surgical site and the surgical navigation system, can be established, thereby realizing real-time intraoperative navigation.

[0069] Based on a comprehensive consideration of technical problems and the shortcomings of existing solutions, this invention uses a detachable, universal marker to replace the tracker fixed on the C-arm gantry. This offers advantages such as convenient installation and universal applicability. Furthermore, combined with a universal patient registration algorithm, it enables millisecond-level rapid, fully automated registration. While solving the compatibility problem of 3D C-arms and breaking the limitations of international 3D C-arm and navigation-based automatic registration protocols, this invention also enables widespread replacement of domestically produced navigation systems and allows the navigation system to be directly applied to C-arms from any manufacturer, eliminating its limitations.

[0070] Those skilled in the art will understand that the embodiments described above are exemplary and can be improved upon. The structures described in the various embodiments can be freely combined without causing any conflict in structure or principle.

[0071] After a detailed description of the preferred embodiments of the present invention, those skilled in the art will clearly understand that various changes and modifications can be made without departing from the scope and spirit of the appended claims, and that the present invention is not limited to the embodiments described in the specification.

Claims

1. A marker device for a surgical navigation system, the marker device comprising: a marker body (1), a plurality of visualization spheres (2) arranged in the marker body, and a plurality of supports (3) for mounting retroreflective spheres, characterized in that the marker body (1) has an upper side provided with the plurality of supports (3) and a lower side opposite the upper side, wherein at least one visualization sphere (2) is arranged on the upper side and the lower side of the marker body (1) respectively, such that the visualization spheres arranged on the upper side of the marker body (1) and the visualization spheres arranged on the lower side of the marker body (1) are spatially oppositely offset, wherein the marker body (1) further comprises a semispherical wall portion (11) for enclosing and holding the visualization spheres (2), a connection hole (12) by means of which the marker device can be fixedly connected with an external connection using a connection member cooperating therewith, an identification arrow (13) on the upper surface of the marker body (1) for indicating the orientation of the marker device in use, and a positioning member (14) for positioning the marker device relative to the external connection and preventing relative rotation therebetween when the marker device is fixedly connected with the external connection, and wherein the marker body (1) is made of a X-ray transparent high molecular material by means of an injection molding process, the visualization spheres (2) are fixed in the marker body by means of an injection molding insert, the supports (3) are fixed in the marker body by means of an injection molding insert process, the connection hole (12) is integrally formed in a tab portion protruding from a lateral edge of the marker body by means of an injection molding process, the identification arrow (13) is integrally formed on the upper surface of the marker body by means of an injection molding process, and the positioning member (14) is integrally formed on the marker body (1) by means of an injection molding process.

2. The marker device of claim 1, wherein, The marker body (1) has a star-shaped flat plate configuration as a whole.

3. Marker device according to claim 1 or 2, wherein The plurality of supports (3) are irregularly distributed on the marker body (1) such that, when retroreflective spheres are mounted on the respective supports (3), at least two retroreflective spheres are spatially oppositely offset from each other.

4. The marker device according to claim 3, further comprising a plurality of holding structures (10) protruding from a surface of the marker body (1), the holding structures (10) each being configured to position and hold a support (3) at an end of the holding structure (10) opposite the surface of the marker body (1), wherein at least two holding structures (10) are configured to extend different distances relative to the surface of the marker body (1) such that the respective supports (3) at the ends of the at least two holding structures (10) form a height difference.

5. The marker device of claim 1 or 2, wherein, The tip end of each support (3) has a circumferential groove (31) for a tight fit with a retroreflective sphere to fixedly mount the retroreflective sphere on the respective support.

6. The marker device of claim 1 or 2, wherein, The marker body (1) further comprises an extension structure (15) extending from a surface of the marker body (1) by a distance, and at least one reflecting ball (2) is located at an end of the extension structure (15) away from the surface of the marker body (1).

7. The marker device of claim 1 or 2, wherein, Two positioning members (14) are provided, which are arranged opposite to each other around the connecting hole (12).

8. A surgical navigation system, characterized by The surgical navigation system comprises the marker device according to any one of the preceding claims.

9. A method for navigation using the marker device according to any one of claims 1 to 7, the method comprising the steps of: A) fixedly connecting the marker device to a surgical area, which refers to an area above a surgical site of a patient; B) tracking the reflecting ball mounted on the marker device by an optical tracking device to obtain the position of the reflecting ball; C) after or simultaneously with step B), scanning the surgical area by an imaging device to obtain an image, wherein the reflecting ball of the marker device is visualized in the image; D) establishing a spatial position relationship between the surgical area and the obtained image; and E) establishing a spatial position relationship between the surgical area and a surgical navigation system.

10. The method of claim 9, wherein, In step E), the spatial position relationship between the surgical area and the surgical navigation system is established according to the relative positions of the reflecting ball and the visualizing ball in the marker device.

Images