Tooling for navigation accuracy testing, apparatus comprising the tooling, and method of testing navigation accuracy

Abstract

The present application relates to a tool (100) for navigation accuracy test, which comprises a tool carrier (10), a phantom part (11) arranged on the tool carrier (10), a tracker (12) arranged on one end of the tool carrier (10), and a plurality of navigation positioning targets (1) which can be detachably connected with the phantom part (11). The present application also provides a device for navigation accuracy test comprising the tool (100), and a method for testing navigation accuracy by using the device.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a navigation accuracy testing fixture, a navigation accuracy testing device including the fixture, and a navigation accuracy testing method. Background Technology

[0002] Currently, a problem exists in medical surgery where the sites of action of surgical instruments cannot be directly observed during the procedure. To reduce fluoroscopic radiation exposure and increase surgical reliability, navigation systems can be used to display surgical segments and instruments, thus assisting in the progress of the surgery.

[0003] Existing orthopedic surgical navigation processes, for example, can be obtained through CN 113199510 A, including the following operations: obtaining image data by performing a CT scan on the patient; then, the computer performs three-dimensional reconstruction of the image data to obtain a virtual model of the patient; using a registration algorithm and an optical tracking device, the relationship between the virtual model and the patient in the coordinate system of the optical tracking device is obtained, and the virtual model and the patient are registered. After successful registration, the system generates a navigation graphic, and the surgical navigation robot or operator can perform surgical operations based on the navigation graphic using execution tools.

[0004] The operational accuracy of a surgical navigation system is extremely important. Therefore, it is necessary to verify the accuracy of the surgical navigation system to ensure that the system's accuracy meets the requirements. Summary of the Invention

[0005] One object of the present invention is to solve at least one of the aforementioned problems and defects existing in the prior art.

[0006] According to one aspect of the present invention, a fixture for testing navigation accuracy is provided, the fixture comprising: a fixture carrier, a phantom portion disposed on the fixture carrier, a tracker disposed on one end of the fixture carrier, and at least one navigation positioning target detachably connected to the phantom portion.

[0007] Optionally, the tracker includes multiple mounting parts for mounting reflective balls.

[0008] Optionally, the tracker also includes a device verification slot.

[0009] Alternatively, the navigation and positioning target is a single piece made of a developable material.

[0010] Alternatively, the navigation and positioning target may include a support member and at least one developing ball disposed on the support member.

[0011] Optionally, the supporting component may include an upper section, a lower section, and an intermediate section located between the upper and lower sections, and the developing ball may be disposed in the upper section and the lower section respectively.

[0012] Optionally, the intermediate section of a single piece or load-bearing component includes a threaded portion, through which the navigation and positioning target can be fixed to a corresponding mating portion in the mold body by means of the threaded portion in a threaded connection manner.

[0013] Optionally, the intermediate section of a single piece or load-bearing component is provided with a protrusion or groove, and the mating part of the mold body is provided with a corresponding groove or protrusion, so that the navigation and positioning target can be fixed to the corresponding mating part of the mold body by means of the cooperation of the protrusion and the groove; or, the intermediate section of a single piece or load-bearing component is provided with a pin or pin hole, and the mating part of the mold body is provided with a corresponding pin hole or pin, so that the navigation and positioning target can be fixed to the corresponding mating part of the mold body by means of the cooperation of the pin and the pin hole.

[0014] Optionally, the upper section includes a cavity, and the developing ball in the upper section is positioned at the bottom of the cavity.

[0015] Optionally, the lower section includes a side recess with a flat side surface, and the developing ball in the lower section is positioned on the side surface of the side recess, so that when the navigation and positioning target is connected, the developing ball in the lower section faces the outside of the tooling and is exposed outward.

[0016] Optionally, the mold body includes multiple detection marks, which are formed as recesses.

[0017] Optionally, the tooling may further include a mounting platform for securing additional components.

[0018] Alternatively, the additional component is an additional tracker.

[0019] Optionally, the phantom partially replicates the vertebral structure of the human body.

[0020] Optionally, the phantom portion is made of an X-ray-transmitting polymer material and is manufactured using 3D printing.

[0021] According to another aspect of the present invention, an apparatus for testing navigation accuracy is also provided, the apparatus comprising surgical instruments, an instrument tracker, and the aforementioned tooling for testing navigation accuracy.

[0022] According to another aspect of the present invention, a method for testing navigation accuracy using the aforementioned apparatus for navigation accuracy testing is also provided, the method comprising the following steps: a) measuring the coordinates of a navigation positioning target of a tooling using a coordinate measuring instrument, wherein the navigation positioning target and the phantom portion of the tooling are connected; b) providing a 3D model of the tooling and registering the 3D model; c) determining the planned position of an implant in a navigation software interface based on the image of the navigation positioning target; d) after removing the navigation positioning target from the phantom portion of the tooling, implanting the implant into the phantom portion of the tooling using surgical instruments, and adjusting the spatial position of the tooling and the implant as needed so that the implant is navigated to the planned position; e) after step d), measuring the coordinates of the implant based on the same coordinate measuring instrument used in step a); and f) comparing the coordinates measured in step a) and step e) respectively to determine the navigation error, the navigation error including position error and / or angle error.

[0023] Optionally, step a) can be performed before or after step b).

[0024] Using the tooling, apparatus, and method according to the present invention, the navigation accuracy of a navigation system can be accurately evaluated. Attached Figure Description

[0025] 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:

[0026] Figure 1 This is a schematic perspective view of a tooling for testing navigation accuracy according to an embodiment of the present invention, wherein a plurality of navigation positioning targets are assembled in corresponding mating parts of the tooling;

[0027] Figure 2 yes Figure 1 The schematic perspective view of the tooling shown shows multiple navigation and positioning targets disengaged from the mating parts of the tooling;

[0028] Figure 3(a) is a schematic front view of a navigation and positioning target according to an embodiment of the present invention;

[0029] Figure 3(b) is a schematic side sectional view of the navigation and positioning target shown in Figure 3(a);

[0030] Figure 3(c) is a schematic diagram of a navigation and positioning target according to another embodiment of the present invention;

[0031] Figure 4This is a schematic perspective view of a surgical stapler instrument, which is available for use. Figure 1 The tooling shown is an example of a surgical instrument used to test navigation accuracy. Detailed Implementation

[0032] The following description, with reference to the accompanying drawings, describes a tooling for testing navigation accuracy according to an embodiment of the present invention. In the following description, numerous specific details are set forth to enable those skilled in the art to gain a more complete understanding of 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.

[0033] Figure 1 A tooling 100 for navigation accuracy testing according to an embodiment of the present invention is schematically shown, wherein a plurality of navigation positioning targets 1 are assembled in corresponding mating parts of the tooling.

[0034] like Figure 1 As shown, the tooling 100 includes a tooling carrier 10, and a phantom portion 11 is disposed on the bearing surface of the tooling carrier 10. By way of example only and not limitation, in this embodiment, the phantom portion 11 replicates the vertebral structure of the human body. The phantom portion 11 can be made of an X-ray-transmitting polymer material and manufactured using 3D printing.

[0035] The tooling 100 has at least one built-in tracker 12, which is disposed at one end of the tooling carrier 10. The platform or support of the tracker 12 is rigidly fixed to that end of the tooling carrier 10. Figure 1 In the illustrated embodiment, the tracker 12 is arranged facing outwards from the tooling (i.e. away from the center of the tooling), preferably tilted upwards at an angle relative to the horizontal bearing surface of the tooling carrier 10, such as less than 90 degrees, preferably less than 60 degrees, for example 45 degrees.

[0036] The tracker 12 may include multiple mounting parts 7 disposed on its platform or bracket for mounting the reflective ball 2. Figure 1 The diagram shows four mounting portions 7 for mounting four reflective balls 2. It is conceivable that five or more mounting portions 7 could be provided to mount five or more reflective balls 2. The mounting portions 7 can be in the form of mounting posts with threaded or snap-fit ​​structures (see [reference]). Figure 2 ).

[0037] In another embodiment, the tracker 12 may omit the platform or bracket. For example, the mounting portion 7 may be directly and rigidly fixed or rigidly connected to the inclined end face of the tooling carrier 10. Alternatively, the mounting portion 7 of the tracker 12 may be integrally formed with the tooling 100 or the tooling carrier 10.

[0038] The reflective ball 2 can be installed to the mounting part 7 via a snap-fit ​​connection or a threaded connection. The reflective ball 2 is used to reflect optical signals (e.g., infrared light) from the light emitting device so that it can be tracked by the navigation system. Furthermore, the reflective balls 2 can be arranged to meet the distribution pattern of the identification and tracking features. For example, in… Figure 1 As shown, the four reflective spheres 2 can be arranged to form a roughly trapezoidal shape. The tilting platform or bracket is rigidly fixed to the end of the fixture 100 to prevent the navigation position from shifting during testing.

[0039] The tracker 12 may also include an instrument verification slot 4. The instrument verification slot 4 is used to verify surgical instruments. During verification, the selected surgical instruments can be inserted into or placed in the instrument verification slot 4 to verify their accuracy with the instruments selected from the software in terms of axial direction, length, etc., thereby avoiding the use of deformed, damaged, or misselected instruments during the operation.

[0040] like Figure 1 and Figure 2 As shown, multiple navigation and positioning targets 1 can be detachably connected to the module part 11. Figure 1 The connection status of multiple navigation and positioning targets 1 assembled in the corresponding mating parts of tooling 100 is shown; Figure 2 The diagram shows the disassembly state of multiple navigation and positioning targets 1 detached from the mating parts of tooling 100.

[0041] The navigation and positioning target 1 may include a supporting member and at least one developing ball 6 disposed on the supporting member. The supporting member of the navigation and positioning target 1 may include an upper section 1a, a lower section 1c, and an intermediate section located between the upper section and the lower section, and the developing ball 6 may be disposed in the upper section 1a and the lower section 1c respectively.

[0042] In one embodiment, the intermediate section may include a threaded portion 1b. The navigation and positioning target 1 can be fixed to a corresponding mating portion in the mold body portion 11 by means of the threaded portion 1b in a threaded connection manner.

[0043] In another embodiment not shown, the intermediate section may be provided with protrusions or grooves, and the mating part of the mold body 11 may be provided with corresponding grooves or protrusions, so that the navigation and positioning target 1 can be fixed to the corresponding mating part of the mold body 11 through the cooperation of the protrusions and grooves.

[0044] In another embodiment not shown, the intermediate section may be provided with pins or pin holes, and the mating part of the mold body 11 may be provided with corresponding pin holes or pins, so that the navigation and positioning target 1 can be fixed to the corresponding mating part of the mold body 11 through the cooperation of the pins and pin holes.

[0045] Each navigation and positioning target 1 may have at least one, preferably two, imaging spheres 6 fixed within it. The imaging spheres 6 are made of a material that can be visualized in medical images, and their function is to serve as the basis for position planning in the testing software. Specifically, through the CT scanning fixture 100, the imaging spheres 6 can be visualized in the image data, thereby enabling the positioning of the corresponding navigation and positioning target 1 in the established 3D (three-dimensional) model of the fixture 100 to be obtained.

[0046] In the embodiments shown in Figures 3(a) and 3(b), the upper section 1a of the support member of the navigation and positioning target 1 may include a cavity, and the lower section 1c may include a side recess with a flat side surface. A developing ball 6 is arranged at the bottom of the cavity and on the side surface of the side recess, respectively. In the connected state of the navigation and positioning target 1, the developing ball 6 arranged on the side surface is positioned in the fixture 100 facing outwards and exposed (see Figure 1). Figure 1 This facilitates the scanning and development of the developing ball 6. By cooperating with the developing ball 6 positioned in the upper section 1a and the developing ball 6 positioned in the lower section 1c, the axial direction or angle of the navigation and positioning target 1 in the connected state can be determined.

[0047] However, the configuration of the navigation and positioning target 1 and the arrangement of the developing sphere 6 are not limited thereto. For example, FIG3(c) schematically depicts another embodiment of the navigation and positioning target 1 according to the present invention.

[0048] As shown in Figure 3(c), the upper section 1a of the support member of the navigation and positioning target 1 may not include a cavity, but has a flat shape, such as a disc. A developing ball can be disposed in the top surface of this disc-shaped upper section 1a. Furthermore, the lower section 1c of the support member may not include a side recess, but is a cylindrical section with a uniform diameter. A developing ball can be disposed on the side or bottom of the cylindrical lower section 1c. Feature structures for fixed connection between the navigation and positioning target 1 and the mold part 11 (e.g., threaded portion 1b, protrusion or groove, pin or pin hole) can be disposed in the intermediate section located between the upper and lower sections.

[0049] Exemplarily, and not limitingly, the developing ball 6 can be adhered to a support member of the navigation and positioning target 1 by adhesive, the support member being made of resin. However, those skilled in the art can also envision using other types of materials to make the support member.

[0050] Furthermore, it can be envisioned that the navigation and positioning target 1 is a single piece made of a developable material, rather than... Figures 3(a) to 3(c) The assembly shown consists of a support member and a developing ball. In this case, the feature structures (e.g., threads, protrusions or grooves, pins or pin holes) for the navigation and positioning target 1 to be fixedly connected to the mold part 11 can be directly provided on this single piece.

[0051] See also Figure 1 and Figure 2 The mold body portion 11 may include a plurality of detection marks 5 formed as recesses. In this embodiment, twenty-five detection marks 5 are provided on the mold body portion 11. The number of detection marks 5 can be determined according to the specific structure and shape of the mold body portion. The detection marks can be used to mark positions for 3D model registration, or as position checks after registration.

[0052] In addition, the tooling 100 may also include a mounting platform 3 for securing additional components (such as additional trackers), such as... Figure 1 and Figure 2 As shown.

[0053] The tooling 100 can be used with surgical instruments. The process of navigation accuracy testing is illustrated below using the stapler 20 as a surgical instrument and the screw 40 as an implant as an example. In this non-limiting example, navigation can be performed on the stapler 20 in conjunction with the screw 40 and the tracker 30.

[0054] According to the present invention, a method for testing navigation accuracy may include the following steps:

[0055] Step a: Use a coordinate measuring machine to measure the coordinates of the navigation and positioning target 1 of the tooling 100, wherein the navigation and positioning target 1 and the mold part 11 of the tooling 100 are in a connected state;

[0056] Step b: Provide a 3D model (e.g., an image) of fixture 100 and perform registration of the 3D model;

[0057] Step c: Based on the imaging of navigation positioning target 1, plan the location of the implant in the navigation software interface, that is, determine the planned location;

[0058] Step d: After disassembling the navigation and positioning target 1, the implant is inserted into the phantom part 11 of the tooling 100 using surgical instruments. If necessary, the spatial position of the tooling 100 and the implant is adjusted so that the implant is navigated to the planned position.

[0059] Step e: Following step d, measure the coordinates of the implant using the same coordinate measuring instrument used in step a; and

[0060] Step f: Compare the coordinates measured in step a and step e respectively, and evaluate the navigation positioning deviation (i.e., position error) and trajectory deviation (i.e., angle error).

[0061] The error obtained in step f is system-level and includes one or more of the following: software algorithm error, tool manufacturing error, tool model error, image error, and human operation error.

[0062] The order of steps a and b above can be interchanged.

[0063] When the surgical instrument is a stapler 20, the implant can be a screw 40.

[0064] However, the above-described navigation accuracy testing method is not limited to using the stapler 20 as a surgical instrument and the screw 40 as an implant to perform the testing process. Obviously, those skilled in the art can conceive of other variations, such as using other types of surgical instruments and / or implants to perform the disclosed method, without departing from the spirit and scope of the navigation accuracy testing method of this disclosure.

[0065] Industrial applicability

[0066] This invention proposes a navigation accuracy measuring device for measuring the accuracy of navigation of surgical instruments using a navigation system. This navigation accuracy measuring device relates to:

[0067] (1) A test fixture with a built-in tracker and additional tracker mounting locations for attaching additional trackers. The 3D model of the fixture's phantom portion can be imported into the test system. The built-in tracker can be recognized by the positioning camera in the navigation system, enabling the navigation test system to locate the test fixture in real time. The imaging features in the phantom portion of the fixture can be used to plan the implant location in the navigation software interface.

[0068] (2) Surgical instruments and an instrument tracker attached thereto, which can be identified and tracked by a positioning camera in conjunction with the instrument tracker. The position error and trajectory error of the navigation system can be determined based on the comparison between the planned position and the actual operation position after navigation, and the navigation accuracy can be accurately evaluated according to the operation procedure.

[0069] The following is an example of how to perform navigation accuracy measurement operations.

[0070] Before navigation, the 3D model of the phantom portion of the test fixture is imported into the test software. The 3D model of the phantom portion is typically acquired using medical imaging equipment (i.e., obtaining a 3D image of the phantom portion). The 3D model of the surgical instrument can be pre-stored in the software system so that its image and pose can be displayed during navigation. Navigation is performed after the phantom portion and surgical instruments have been correctly registered and aligned.

[0071] Position planning can be performed in the navigation software interface based on the 3D image of the model and the development of the navigation positioning target.

[0072] Before or after location planning, a coordinate measuring machine is used to measure the physical coordinates (i.e., spatial coordinates) of the navigation and positioning target.

[0073] The navigation and positioning target is detached from the tooling module, and the surgical instruments (such as staplers) are navigated to the planned position on the navigation software interface.

[0074] Once navigation is confirmed, fix the fixture and implant, and use the same coordinate measuring instrument as before to measure the physical coordinate position of the implant, i.e., the actual coordinates of the implant.

[0075] Compare the coordinate errors between the physical coordinates of the planned location and the physical coordinates of the implant after navigation, including calculating the implant tip position error and trajectory error.

[0076] 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.

[0077] 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 fixture (100) for testing navigation accuracy, characterized in that, The tooling includes: Work load carrier (10), The mold part (11) is arranged on the tooling carrier (10). A tracker (12) is arranged on one end of the tooling carrier (10), and At least one navigation and positioning target (1) that can be detachably connected to the phantom part (11). The navigation and positioning target (1) includes a supporting member and at least one developing ball (6) disposed on the supporting member. The supporting member includes an upper section (1a), a lower section (1c), and an intermediate section located between the upper and lower sections. The developing ball (6) is disposed in the upper section (1a) and the lower section (1c), respectively. The upper section (1a) includes a cavity, and the developing ball (6) in the upper section is positioned at the bottom of the cavity. The lower section (1c) includes a side recess with a flat side surface, and the developing ball (6) in the lower section is positioned on the side surface of the side recess, so that when the navigation positioning target (1) is connected, the developing ball (6) in the lower section faces the outside of the tooling and is exposed outward.

2. The fixture (100) for navigation accuracy testing according to claim 1, wherein, The tracker (12) includes multiple mounting parts (7) for mounting the reflective ball (2).

3. The fixture (100) for navigation accuracy testing according to claim 1, wherein, The tracker (12) also includes a device verification slot (4).

4. The fixture (100) for navigation accuracy testing according to claim 1, wherein, The middle section of the bearing member includes a threaded portion (1b), through which the navigation and positioning target (1) can be fixed to the corresponding mating portion in the mold part (11) by means of the threaded portion (1b) in a threaded connection manner.

5. The fixture (100) for navigation accuracy testing according to claim 1, wherein, The middle section of the bearing member is provided with protrusions or grooves, and the mating part of the mold part (11) is provided with corresponding grooves or protrusions, so that the navigation and positioning target (1) can be fixed to the corresponding mating part of the mold part (11) through the cooperation of the protrusions and grooves; or The middle section of the bearing member is provided with a pin or pin hole, and the mating part of the mold part (11) is provided with a corresponding pin hole or pin, so that the navigation and positioning target (1) can be fixed to the corresponding mating part of the mold part (11) through the cooperation of the pin and the pin hole.

6. The fixture (100) for navigation accuracy testing according to any one of claims 1 to 5, wherein, The mold part (11) includes a plurality of detection marks (5), which are formed as pits.

7. The tooling (100) for testing navigation accuracy according to any one of claims 1 to 5 further includes a mounting platform (3) for fixing additional components.

8. The fixture (100) for navigation accuracy testing according to claim 7, wherein, The additional component is a separate tracker.

9. The fixture (100) for navigation accuracy testing according to any one of claims 1 to 5, wherein, The phantom part (11) replicates the vertebral structure of the human body.

10. The fixture (100) for navigation accuracy testing according to any one of claims 1 to 5, wherein, The phantom part (11) is made of X-ray-transmitting polymer material and is manufactured using 3D printing.

11. An apparatus for testing navigation accuracy, characterized in that, The device includes surgical instruments, an instrument tracker (30), and a tooling (100) for testing navigation accuracy according to any one of claims 1-10.

12. A method for testing navigation accuracy using the apparatus for navigation accuracy testing according to claim 11, characterized in that, The method includes the following steps: a) Measure the coordinates of the navigation and positioning target (1) of the tooling (100) using a coordinate measuring instrument, wherein the navigation and positioning target (1) and the mold part (11) of the tooling (100) are in a connected state; b) Provide a 3D model of the tooling (100) and perform registration of the 3D model; c) Determine the planned location of the implant in the navigation software interface based on the imaging of the navigation positioning target (1); d) After the navigation and positioning target (1) is removed from the phantom part (11) of the tooling (100), the implant is inserted into the phantom part (11) of the tooling (100) using surgical instruments, and the spatial position of the tooling (100) and the implant is adjusted as needed so that the implant is navigated to the planned position. e) Following step d), measure the coordinates of the implant using the same coordinate measuring instrument used in step a); and f) Compare the coordinates measured in step a) with those measured in step e) to determine the navigation error, which includes position error and / or angle error.

13. The method according to claim 12, wherein, Step a) is performed before or after step b).

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