CN116616896A - Marker device, surgical navigation system including same and method of navigation using same - Google Patents

Abstract

The invention relates to a marker device for a surgical navigation system, the marker device comprising: a marker body (1), a plurality of developing balls (2) arranged in the marker body, and a reflective ball for installing multiple supports (3). 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 A developing ball (2) makes the developing ball arranged on the upper side of the marker body (1) and the developing ball arranged on the lower side of the marker body (1) relatively offset in space. The invention also relates to a surgical navigation system comprising the marker device and a method of navigation using the marker device.

Description

Marker device, surgical navigation system including same and method of navigation using same

technical field

The present invention relates to the technical field of medical equipment, in particular to a surgical navigation system, and more particularly to a marker device for the surgical navigation system and a registration method for the surgical navigation system using it.

Background technique

It is known to take images of patients with imaging devices comprising, for example, two-dimensional C-arms, three-dimensional C-arms or O-arms. These imaging devices can take images of the patient's treatment site during the operation, so as to register for the surgical navigation system to guide the surgical operation.

At present, there are many types of imaging devices in the market, with various configurations. However, the racks of some imaging equipment are not or cannot be installed with trackers, so they cannot be identified and cannot be directly used in surgical navigation systems.

In addition, some imaging devices support the use of specific installation methods to connect additional trackers, but the physical parameters of the additional tracker and the existing trackers on the rack are not necessarily the same, and the underlying connection protocols are also different, so there is no universal At the same time, due to repeated installation and repeated calibration, the accuracy and ease of operation of the navigation system are reduced. So, even if only for devices that already have trackers, they need to match each other. However, if trackers from different manufacturers are paired one by one, it will take a lot of time and effort.

Therefore, a general solution is needed to solve the above problems.

Contents of the invention

An object of the present invention is to solve one of the above-mentioned problems and disadvantages in the prior art.

According to one aspect of the present invention, a marker device for a surgical navigation system is provided, the marker device comprising: a marker body, a plurality of developing balls arranged in the marker body, and a reflective ball for installing multiple supports. 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 developing ball is respectively arranged on the upper side and the lower side of the marker body such that The developing ball on the upper side of the body and the developing ball arranged on the lower side of the marker body are relatively offset in space.

Optionally, the body of the marker as a whole is in the shape of a star-shaped plate.

Optionally, the plurality of support members are scattered and arranged on the marker body in an irregular manner, so that when the reflective balls are installed on the corresponding support members, at least two reflective balls are spatially offset relative to each other.

Optionally, the marker device further includes a plurality of holding structures protruding from the surface of the marker body, and the holding structures are respectively used to position and hold the support on the surface of the holding structure and the marker body. Opposite ends wherein at least two retaining structures are configured to extend different distances relative to said surface of the marker body such that respective supports at ends of said at least two retaining structures form a height difference.

Optionally, the tip end of each supporting piece has a circumferential groove, and the circumferential groove is used to tightly fit with the reflective ball so that the reflective ball is fixedly installed on the corresponding supporting piece.

Optionally, the marker body further comprises an extension structure extending a distance from the surface of the marker body, at least one developing sphere is located at an end of the extension structure away from the surface of the marker body.

Optionally, the marker body also includes one or more of the following:

1) A hemispherical wall for enclosing and holding the developing sphere;

2) a connecting hole, by means of which the marker device can be fixedly connected to an external connector by means of a connecting member cooperating with the connecting hole;

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

4) A positioning member for positioning the marker device relative to the external connector and preventing relative rotation therebetween when the marker device is fixedly connected thereto.

Optionally, the marker body is made of an X-ray transparent polymer material through an injection molding process, the developing ball is fixed in the marker body through an injection molding insert, and the support is fixed in the marker body through an injection molding insert process, The connection hole is integrally formed in the tongue part protruding from the side edge of the marker body by injection molding process, the identification arrow is integrally formed on the upper surface of the marker body by injection molding process, and/or the positioning member is integrally formed on the marker body by injection molding process on the object itself.

Optionally, there are two positioning members arranged opposite to each other around the connection hole.

According to another aspect of the present invention, a surgical navigation system is provided, which includes the aforementioned marker device.

According to yet another aspect of the present invention, there is provided a navigation method using the aforementioned marker device, the method comprising the following steps:

A) Fixed attachment of the marker device at or near the surgical field;

B) track the reflective ball installed on the marker device through optical tracking equipment to obtain the position of the reflective ball;

C) after step B) or at the same time as step B), use an imaging device to scan the operation area to obtain an image, wherein the developing ball of the marker device is developed in the image;

D) establishing a spatial positional relationship between the surgical field and the acquired images; and

E) Establish the spatial position relationship between the surgical area and the surgical navigation system.

Optionally, in step E), the spatial positional relationship between the surgical area and the surgical navigation system is established according to the relative positions of the developing ball and the reflective ball in the marker device.

The marker device according to the present invention has the following advantages: the manufacturing process is simple; the overall shape is regular and beautiful; it has a developing ball arrangement that forms a certain height difference, and the reflective ball can also form a height difference after installation, the structure is stable and durable, and the registration is fast Accurate and widely applicable; convenient and stable connection with external connectors; suitable for registration of 3D surgical navigation systems from different manufacturers.

Description of drawings

The invention is described in detail below by way of non-limiting examples with reference to the accompanying drawings, which are only schematic and not necessarily drawn to scale, and in addition they only show those parts which are necessary for elucidating the invention, while others Sections may be omitted or only briefly mentioned. That is, the present invention may include other components in addition to those shown in the drawings. In the attached picture:

Figure 1 is a schematic top perspective view of a marker device according to one embodiment of the present invention;

Figure 2 is a schematic bottom perspective view of the marker device shown in Figure 1;

Figure 3 is a schematic front view of the marker device shown in Figure 1;

FIG. 4 is a schematic cross-sectional view of the marker device shown in FIG. 1 .

Detailed ways

A marker device for a surgical navigation system according to an embodiment of the present invention will be described below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to enable those skilled in the art to fully understand the present invention. It will be apparent, however, to one skilled in the art that the present invention may be practiced without some of these specific details. Furthermore, it should be understood that the invention is not limited to the particular embodiments described. Instead, it is conceivable to implement the present invention in any combination of the following features and elements, regardless of whether they relate to different embodiments. Accordingly, the following aspects, features, embodiments and advantages are by way of illustration only and should not be considered elements or limitations of the claims unless explicitly stated in the claims.

The "upper" and "lower" herein refer to the relative spatial position relationship in the y-axis direction with reference to the coordinate system shown in the figure. However, the above-mentioned coordinate system does not constitute a limitation of the present invention. Those skilled in the art can understand that the marker device can be arranged arbitrarily according to needs during use.

Fig. 1 schematically shows a marker device for a surgical navigation system according to an embodiment of the present invention. The marker device comprises a marker body 1 , a plurality of developing balls 2 arranged in the marker body (see FIG. 4 ), and a plurality of support members 3 for installing reflective balls (not shown).

As shown in FIG. 1 and FIG. 2 , the marker body 1 can be in a star-shaped (eg four-pointed star-shaped) flat plate configuration as a whole. Therefore, the bottom of the marker device is relatively flat and can be directly attached to the patient's body surface.

The marker body 1 can be made of X-ray transparent polymer material through injection molding process. However, the production of the marker body according to the present invention is not limited to such production and production.

As best shown in FIG. 3 , in this embodiment the marker body 1 may have an upper side and a lower side opposite said upper side, wherein a plurality of supports 3 are arranged on the upper side of the marker body 1 .

Referring to Fig. 4, at least one developing ball 2 is respectively arranged on the upper side and the lower side of the marker body 1, so 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 The balls 2 are relatively offset in space, for example forming a height difference in the vertical direction as shown by the y-axis.

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 relatively offset in the horizontal direction as shown by the x-axis.

In an exemplary marker device, seven developing balls 2 are included in total, among which five developing balls 2 are scattered on the lower side of the marker body 1, and the other two developing balls 2 are scattered on the upper side of the marker body 1. 1 and 2, wherein the developing ball 2 is surrounded by a hemispherical wall portion 11 which will be described in detail below).

The size, quantity and distribution rules of the developing balls 2 can be specifically designed according to specific algorithms. The material of the developing ball 2 only needs to be able to be developed in medical imaging equipment.

All visualization spheres 2 in a marker arrangement may have the same diameter.

Referring to FIG. 1 , FIG. 2 and FIG. 4 , the marker body 1 may further 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, and the hemispherical wall portion 11 on the marker body 1 facilitates accurate positioning of the developing ball 2 during the injection molding process.

As shown in FIG. 3 , at least one hemispherical wall portion 11 may be arranged at an extension structure 15 protruding a distance from the surface of the marker body, so that the developing sphere 2 surrounded by the hemispherical wall portion 11 is arranged opposite to the The developer balls 2 on one side are spaced apart by a greater distance, especially in the vertical direction as shown by the y-axis.

In addition, the marker body 1 may also include a connecting hole 12, such as a threaded hole. Thereby, the marker device can be fixedly connected to the external connector by means of the connection hole 12 and with a connection member cooperating with the connection hole, for example a threaded member (not shown). The connecting members may be bolts. The connecting hole 12 can be integrally formed in the approximate center of the marker body 1 through injection molding process, so that the central axis of the connecting hole 12 can be positioned at the position where the center of gravity of the marker body 1 is located.

However, the way the marker device of the present invention is connected to the external connector is not limited to threaded connection, but may also be a snap connection or adhesive tape adhesion, and the like.

In addition, the marker body 1 may also include a positioning member 14 . In the embodiment shown in FIG. 1 , the positioning member 14 is configured in the form of a positioning post. Advantageously, two positioning members 14 are arranged opposite each other around the connection hole 12 . When the marker device is fixedly connected to the external connection, the positioning member 14 can be utilized to position the marker device relative to the external connection and prevent relative rotation therebetween. For this purpose, corresponding slots that can cooperate with the positioning member 14 can be provided on the external connecting piece. The positioning member 14 can be integrally formed on the marker body 1 through injection molding process.

The external connector can be an adhesive (such as tape), a universal arm, or other specially designed special connector, etc., as long as it can firmly position the marker device in the surgical field and/or the patient's surgical site.

Referring to Fig. 1, a plurality of (in this embodiment, 4) supports 3 are irregularly scattered and arranged on the outer periphery of the marker body 1, so that when the reflective ball is installed on the corresponding supports 3, at least two The reflective spheres are spatially offset relative to each other.

Specifically, in this embodiment, the marker device according to the present invention may further include a plurality of holding structures 10 protruding from the surface (preferably the upper surface) of the marker body 1 (see FIGS. 1 and 2 ). The holding structure 10 can respectively position and hold the support 3 at the end of the holding structure 10 opposite said surface of the marker body 1 . At least two holding structures 10 can be configured to extend different distances relative to said surface of the marker body 1 , so that the corresponding supports 11 at their ends form a height difference.

Therefore, when the reflective balls are installed in the marker device, the plurality of reflective balls can be distributed irregularly in the space where the marker body 1 is located as a whole, which is beneficial to be identified by the optical tracking system.

The supporting member 3 is made of X-ray transparent material or a material without large artifacts under X-ray (such as metal), and is fixed in the marker body 1 by injection molding insert technology. During manufacture, metal sub-parts, such as metal preforms or blanks, are injection molded into the marker body to form the support 3 . When using the marker device, the reflective ball can be inserted on the support member 3, and the reflective ball can be pulled out after use. Therefore, the marker device according to the present invention is not only more durable and not easily deformed, but also can install and disassemble the reflective ball more conveniently.

In the present exemplary embodiment, the support 3 is configured in the form of a strut. As shown in FIGS. 3 and 4 , the tip end of each support 3 may have a circumferential groove 31 . The circumferential groove 31 can be used to closely cooperate with the reflective ball so that the reflective ball can be fixedly installed on the corresponding supporting member 3 . After being inserted on the support 3 , the reflective ball can closely fit with the support 3 .

However, the installation method of the reflective ball is not limited thereto. For example, it is conceivable that the support member 3 is provided with external threads, and the reflective ball is provided with corresponding internal threads, so that the reflective ball can be fixedly connected to the support member 3 by screwing.

In addition, the marker body 1 may also include an identification arrow 13 . The identification arrow 13 is arranged on the upper surface of the marker body 1 for indicating the orientation of the marker device in use.

For example, the identification arrow 13 may point to the side where the supporting member 3 with a shorter distance from the surface of the marker body 1 is located and thus has a smaller height, so that: Compared with the side, the side of the marker body 1 where the support 3 is located with a smaller height is closer to the external optical tracking device. Therefore, the installed reflective ball is not easy to be blocked, which is more conducive to being recognized by the optical tracking system.

The marker device according to the present invention has a firm structure and is not easily deformed, so that the position changes of the developing ball and the installed reflective ball are smaller and the positioning is more accurate.

When utilizing the marker device according to the present invention for surgical navigation, a method comprising the following steps may be performed:

Step A): The marker device is fixedly connected to or near the surgical area (including the surgical site of the patient);

Step B): tracking the reflective ball installed on the marker device by an optical tracking device to obtain the position of the reflective ball;

Step C): after step B) or at the same time as step B), use an imaging device to scan the operation area to obtain an image, wherein the developing ball of the marker device is developed in the image;

Step D): establishing the spatial positional relationship between the surgical region and the acquired images; and

Step E): establishing the spatial position relationship between the surgical area and the patient's surgical site and the surgical navigation system.

In step E), the spatial positional relationship between the surgical area and the surgical navigation system can be established according to the relative positions of the developing ball and the reflective ball in the marker device.

Industrial Applicability

During the navigation operation, the corresponding external component reflective ball is first installed on the support member 3 (i.e. the column) on the marker body 1, so that the reflective ball and the marker device are integrated; then the external connecting member (such as a connecting rod) The positioning member 14 on the marker body 1 is positioned and connected to the marker device, and then the external bolt passes through the threaded connection hole 12 on the marker body 1 to lock and fix the marker device and the external connecting rod, and is integrally fixed on the marker device. Surgical area (such as above the patient's surgical site), and point the identification arrow on the marker device to the external optical tracking device (especially the camera of the optical tracking device). After the intraoperative image scanning and the identification of the marker device by the optical tracking equipment, the spatial position relationship between the surgical area and the patient's intraoperative image can be established, and the spatial position relationship between the patient's surgical site and the surgical navigation system can be established, so that Realize intraoperative real-time navigation.

Based on the comprehensive consideration of the technical problems and the shortcomings of existing solutions, the present invention adopts a detachable universal marker to replace the fixed tracker on the C-arm frame, which has the advantages of convenient installation and universal applicability. Quasi-algorithm, which can realize fast and fully automatic registration in milliseconds. While solving the problem of universal matching of the 3D C-arm and breaking the limitation of the international 3D C-arm and navigation automatic registration agreement, it can also realize a wide range of domestic navigation substitutions, and make the navigation can be directly applied to any manufacturer's C shaped arm, eliminating its limitations in use.

Those skilled in the art can understand that the above-described embodiments are exemplary, and those skilled in the art can improve them, and the structures described in various embodiments do not conflict with each other in terms of structure or principle Can be combined freely.

After describing the preferred embodiments of the present invention in detail, those skilled in the art can clearly understand that various changes and changes can be made without departing from the scope and spirit of the appended claims, and the present invention is not limited by Implementation is limited to the exemplary embodiments set forth in the specification.

Claims (12)

1. A marker device for a surgical navigation system, the marker device comprising:

a marker body (1),

a plurality of developing balls (2) arranged in the marker body, and

a plurality of supports (3) for mounting the reflective balls,

it is characterized in that the method comprises the steps of,

the marker body (1) has an upper side provided with the plurality of supporting members (3) and a lower side opposite to the upper side, wherein at least one developing ball (2) is arranged at the upper side and the lower side of the marker body (1), respectively, such that the developing ball arranged at the upper side of the marker body (1) and the developing ball arranged at the lower side of the marker body (1) are offset spatially relative to each other.

2. Marker arrangement according to claim 1, wherein the marker body (1) as a whole is in a star-shaped flat configuration.

3. A marker arrangement according to claim 1 or 2, wherein the plurality of support members (3) are arranged in an irregular manner distributed over the marker body (1) such that at least two light reflecting balls are spatially offset relative to each other when the light reflecting balls are mounted to the respective support members (3).

4. A marker arrangement according to claim 3, further comprising a plurality of holding structures (10) protruding from the surface of the marker body (1), said holding structures (10) being for positioning and holding the support (3) at the end of the holding structure (10) opposite to said surface of the marker body (1), respectively, wherein at least two holding structures (10) are configured to extend different distances relative to said surface of the marker body (1) such that the respective supports (11) at the ends of said at least two holding structures (10) form a height difference.

5. Marker arrangement according to claim 1 or 2, wherein the tip of each support (3) has a circumferential groove (31) for a close fit with the reflector ball for a fixed mounting of the reflector ball on the respective support.

6. Marker arrangement according to claim 1 or 2, wherein the marker body (1) further comprises an extension structure (15) protruding a distance from the surface of the marker body (1), at least one developing ball (2) being located at an end of the extension structure (15) remote from the surface of the marker body (1).

7. The marker device according to claim 1 or 2, wherein the marker body (1) further comprises one or more of the following:

a hemispherical wall portion (11) for surrounding and holding the developing ball (2);

a connection hole (12) by means of which the marker device can be fixedly connected to an external connection piece by means of a connection element cooperating with the connection hole;

an identification arrow (13) located 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 connector and preventing relative rotation therebetween when fixedly connecting the marker device to the external connector.

8. The marker device of claim 7, wherein,

the marker body (1) is made of high polymer material which can transmit X-rays through an injection molding process,

the developing ball (2) is fixed in the marker body by injection molding insert mode,

the support (3) is fixed in the marker body by an injection molding insert process,

the attachment hole (12) is integrally formed in a tab portion protruding from a side edge of the tag body by an injection molding process,

the marking arrow (13) is integrally formed on the upper surface of the marker body through an injection molding process, and/or

The positioning member (14) is integrally formed on the marker body (1) by an injection molding process.

9. Marker device according to claim 7, wherein two positioning members (14) are provided, which are arranged opposite each other around the connection hole (12).

10. A surgical navigation system, characterized in that it comprises a marker device according to any of the preceding claims.

11. A method of navigating with a marker device according to any one of claims 1 to 9, the method comprising the steps of:

a) Fixedly attaching a marker device at or near the surgical field;

b) Tracking a reflective ball mounted on the marker device by an optical tracking device to obtain the position of the reflective ball;

c) Scanning the surgical field with an imaging device to acquire an image after or simultaneously with step B), wherein a developing ball of the marker device is developed in the image;

d) Establishing a spatial position relationship between the operation area and the acquired image; and

e) A spatial positional relationship between the surgical field and the surgical navigation system is established.

12. The method according to claim 11, wherein in step E), a spatial positional relationship between the surgical field and the surgical navigation system is established according to the relative positions of the developing ball and the reflecting ball in the marker device.