Positioner and positioning device for orthopedic navigation surgery

Abstract

The invention relates to a positioner and a positioning device, and the positioner comprises a main body part which is in a plate shape and is provided with a first surface and a second surface; the positioning column extends from the first surface, the positioning column is provided with a first hole and a second hole which are connected with each other, and the diameter of the first hole is larger than that of the second hole. The navigation device is particularly used for orthopedic navigation surgery, stable connection is formed with the bone of a patient, calibration points scanned by image scanning equipment can be rapidly recognized in the manual registration process, the calibration points can be rapidly touched and calibrated through a navigation probe, and the operation is convenient. And the registration precision, the navigation precision of the navigation operation and the operation success rate are improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical instruments, and in particular to a positioner and a positioning device, especially for orthopedic navigation surgery. Background Art

[0002] my country is a country with a high incidence of spinal diseases. According to data from the National Health Commission, as early as 2015, the number of patients with lumbar spondylosis in China exceeded 200 million. Surgical treatment is a good solution for many spinal diseases. In recent years, navigation technology, as one of the most effective auxiliary technologies for the treatment of spinal diseases, has been widely used at home and abroad.

[0003] As a solution for spinal navigation surgery, the navigation system can use automatic registration technology, which is convenient and fast, but there are problems such as poor compatibility between different imaging devices and poor real-time data transmission, which limits the use of navigation systems in my country's sinking medical market to improve the success rate of spinal surgery. Although manual registration can make the navigation system work with most of the imaging equipment on the market, traditional manual registration still has some challenges. Because the basic logic of manual registration is to register the patient's actual anatomical structure feature points to the image, some specific anatomical landmarks on the bone surface need to be exposed during manual registration. After defining these landmarks in the navigation system, these landmarks are touched with a medical probe for registration. The challenges brought by such a process include: more steps that require medical staff to actively operate; specific anatomical landmarks are difficult to expose or touch due to the diversity of the patient's anatomical features; the matching of actual anatomical bone surface landmarks with the landmarks defined in the system is highly dependent on the professional skills and experience of medical staff, and there is a high threshold for surgery; the operation time is prolonged; the risk of secondary injury / secondary infection of patients increases, etc. Summary of the invention

[0004] In order to solve the above technical problems at least to a certain extent, the present invention proposes the following solutions.

[0005] A locator, comprising:

[0006] A main body portion, the main body portion is in a plate shape and has a first surface and a second surface;

[0007] A positioning post extends from the first surface and has a first hole and a second hole connected to each other, wherein a diameter of the first hole is greater than a diameter of the second hole.

[0008] According to an example of the present invention, the main body portion has an adjustment path that runs through the first surface and the second surface, and the adjustment path is located within the outer contour of the main body portion.

[0009] According to an example of the present invention, viewed along a direction perpendicular to the first surface or the second surface, the adjustment path is formed by a straight line or an arc or a combination of the two.

[0010] According to an example of the present invention, the portion of the main body corresponding to the first hole of the positioning column has a hole penetrating the first surface and the second surface, a metal element is arranged in the first hole and is inserted through the hole of the main body, and the metal element is tightly fitted with the first hole; and / or the second hole is an elongated hole; preferably, the main body is made of plastic, and a positioning pin made of metal is also arranged in the main body.

[0011] According to an example of the present invention, the main body portion and the positioning posts are integrally formed; and / or the number of the positioning posts is 8, 9 or 10.

[0012] According to an example of the present invention, the outer contour of the positioner is provided with at least one recess.

[0013] The present invention also proposes a positioning device, comprising:

[0014] The above-mentioned locator;

[0015] an actuating device having a rotating component;

[0016] The clamping device has a first part and a second part, and the clamping device is located at one side of the positioner; the rotating component passes through the positioner and one end of the rotating component can apply a force to the first part so that the first part and the second part rotate relative to each other.

[0017] According to an example of the present invention, the first part includes a first clamping portion and a pressed portion;

[0018] The second portion includes a connecting portion and a second clamping portion;

[0019] Preferably, when the first clamping portion and the second clamping portion are in a clamping state, the clamping surfaces of the first clamping portion and the second clamping portion are at an angle, and preferably the distance between the clamping surfaces of each clamping portion at a portion away from the rotation axis of the clamping portion is smaller than the distance between the clamping surfaces at a portion close to the rotation axis of the clamping portion;

[0020] Preferably, each clamping surface has a plurality of sharp portions, and the sharp portions on the two clamping surfaces are arranged alternately.

[0021] According to an example of the present invention, the rotating component includes a threaded portion, an operating portion, and a pressurizing portion, the threaded portion has an external thread and cooperates with the threaded hole on the connecting portion, the pressurizing portion can cooperate with the pressurized portion of the first part, and the pressurizing portion is preferably conical;

[0022] Preferably, when the first clamping portion and the second clamping portion are in a clamping state, the force arm of the moment borne by the pressure-bearing portion is substantially equal to the force arm of the first clamping portion.

[0023] According to an example of the present invention, the actuating device further comprises an actuating tool having an operating hole, wherein the operating hole is used to actuate the operating part so as to rotate the rotating part and move along its own axis; preferably, the operating hole is square and the operating part is also square.

[0024] According to an example of the present invention, it further includes an adjusting device, which is arranged between the positioner and the clamping device and is used to adjust the positioner along a direction perpendicular to the first surface.

[0025] As can be seen from the above, the present invention proposes a locator and a positioning device including the locator, which is particularly used for orthopedic navigation surgery. By forming a stable connection with the patient's bone, the calibration points scanned by the image scanning device can be quickly identified during the manual alignment process, and the navigation probe can be used to quickly touch and calibrate these calibration points. Compared with the traditional manual alignment process, the alignment time is greatly reduced, the patient's exposure time is reduced, and the probability of infection is reduced. At the same time, the degree of standardization of the manual alignment process is improved, the operation process is simplified, and the surgeon can find the alignment calibration points more quickly and accurately, and the alignment accuracy is improved, that is, the navigation accuracy and surgical success rate of subsequent navigation surgery are improved.

[0026] Other features and advantages of the present invention will be apparent from the following detailed description in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The features and advantages of the present invention will be clearly understood through the detailed description provided below with reference to the accompanying drawings. It should be understood that the following drawings are only schematic and not necessarily drawn to scale, and thus cannot be regarded as limiting the present invention, wherein:

[0028] Figure 1 A three-dimensional schematic diagram of a positioning device for orthopedic navigation surgery according to the present invention is shown.

[0029] Figure 2 A plan view of a positioner in a positioning device according to the present invention is shown.

[0030] Figure 3 A front view of a clamping device and a part of an actuating device in a positioning device according to the present invention is shown.

[0031] Figure 4 A perspective view showing an actuating tool in a positioning device according to the present invention is shown. DETAILED DESCRIPTION

[0032] Embodiments of the present invention are described below with reference to the accompanying drawings. In the following description, many specific details are set forth so that those skilled in the art can more fully understand and implement the present invention. However, it will be apparent to those skilled in the art that the present invention may be implemented without some of these specific details. In addition, it should be understood that the present invention is not limited to the specific embodiments described. On the contrary, any combination of the features and elements described below may be considered to implement the present invention, regardless of whether they relate to different embodiments. Therefore, the following aspects, features, embodiments and advantages are intended for illustration purposes only and should not be considered as features or limitations of the claims unless explicitly stated in the claims.

[0033] In the following description, the descriptions about directions, such as "upper", "lower", "inner", "outer", "radial", "axial", etc., which may be used, are only for the convenience of description, unless otherwise specified, and are not intended to form any limitation on the technical solution of the invention. In addition, in the following description, terms such as "first", "second", etc. are used to describe the elements of the present application, and these terms are only used to distinguish the elements, and are not intended to limit the nature, sequence, order or number of these elements.

[0034] Figure 1 FIG. 2 shows a three-dimensional schematic diagram of a positioning device for orthopedic navigation surgery according to the present invention. Figure 1 It can be seen from the figure that the positioning device for orthopedic navigation surgery according to the present invention mainly includes a positioner 10, an actuating device 20, an adjusting device 30 and a clamping device 40.

[0035] The following combination Figures 2 to 4 The positioning device for orthopedic navigation surgery of the present invention is further described. Figure 2 FIG. 1 is a plan view of a positioner in a positioning device according to the present invention. As an important component of the present invention, the positioner 10 includes a plate-shaped main body portion 11, whereby the main body portion 11 has a first surface and a second surface that are substantially parallel. The first surface is Figure 1 The second surface can therefore be referred to as the lower surface, which is Figure 2 Shown in.

[0036] A plurality of positioning posts 12 extending from the first surface are provided on the first surface. The positioning posts 12 are preferably perpendicular to the first surface. The position, number and height of the positioning posts 12 can be specifically set according to the registration system. According to a preferred embodiment of the present invention, the number of the positioning posts 12 is at least 8, preferably 10.

[0037] The positioning column 12 has a through hole perpendicular to the first surface. Figure 1 and Figure 2As shown, the first hole 121 and the second hole 122 are connected to each other, but the diameters of the two holes are different. Specifically, the diameter of the first hole 121 is larger than the diameter of the second hole 122. Thus, the first hole and the second hole form a stepped hole. A metal element 123, such as a metal ball, is arranged in the first hole 121 to serve as a positioning and developing element. The metal element 123 is installed in the first hole 121 at the second surface, and is blocked by the step portion between the first hole 121 and the second hole 122 and does not pass through the second hole 122, and stays in the first hole 121 by a tight fit with the first hole 121.

[0038] When the metal element is a spherical element, the first hole and the second hole can be cylindrical holes, and the diameter of the spherical element is larger than the diameter of the first hole and the second hole. The metal ball is loaded into the first hole from the second surface by the tooling, for example, by designing the length of the second hole, it is ensured that the distance from each metal developing ball to the upper end surface of the positioning column is within a very small tolerance range.

[0039] During use, such as during surgery, a detection element, such as a probe, may pass through the second hole 122 to detect, for example, contact with a metal element.

[0040] Preferably, the substrate is made of a plastic material that is light-transmissive under imaging and has biocompatibility, and the developing ball is made of a developing metal material.

[0041] As an improvement of the present invention, the positioning column 12 is integrally formed with the main body 11. Considering that the positioner 10 needs to be sterilized or cleaned, it needs to be in a hot and humid environment or be flown through or soaked by water. Therefore, the positioning column and the main body are arranged to be integrally formed, which not only facilitates manufacturing and reduces manufacturing costs, but is also more conducive to maintaining structural stability during repeated hot and humid sterilization, and will not produce failures such as cracks and deformation. In comparison, the split structure is more troublesome to assemble, and there will be a gap between the two different components after assembly, which makes it difficult to clean water stains or contamination residues during hot and humid sterilization or flushing or soaking with water.

[0042] Preferably, the second hole 122 is also used as a positioning hole or a guide hole by being set as an elongated hole. Specifically, the diameter and depth of the second hole 122 are set so that when the probe is passed through the second hole and contacts the metal ball, the second hole 122 limits the shaking of the probe with its wall surface, thereby improving the positioning accuracy. On the one hand, the diameter of the second hole is slightly larger than the diameter of the probe, and on the other hand, the depth of the second hole enables the probe to penetrate a certain distance into the second hole. In addition, this elongated setting of the second hole can also play a role in guiding the probe.

[0043] As a further improvement of the present invention, a positioning pin 13 is also provided on the main body 11. The positioning pin 13 is approximately located between the first surface and the second surface and can also be used as a developing element. By providing the positioning pin, the user can more quickly determine the position of each developing ball in the image after taking the three-dimensional CT, thereby helping to understand and determine which developing ball to start the probe touch registration.

[0044] join Figure 2 The main body 11 is also provided with a recess, specifically, one or more recesses 111 located on the outer contour of the main body 11 . Figure 2 Two locations are shown in the figure, and the two locations are respectively arranged on opposite sides of the main body 111. The recess 111 serves as an avoidance feature to avoid other instruments used in the operation.

[0045] The main body 11 is also provided with an adjustment path 112. The adjustment path 112 is a hole with a certain length, so that the main body 11 can move laterally along the actuator, thereby adjusting the lateral position of the positioner 10. The adjustment path 112 can be a straight line segment, or an arc, or a combination of the two.

[0046] In conjunction with this, Figure 1 As shown, the positioning device of the present invention is preferably further provided with an adjusting device 30. The adjusting device 30 is used to adjust the longitudinal position of the positioning device 10, so as to adapt to patients of different body shapes and different fat layer thicknesses, and ensure that the system is clamped smoothly without interfering with the patient. Specifically, the adjusting device 30 with different thicknesses can be used as needed. The adjusting device 30 preferably adopts a plate-like structure.

[0047] Figure 3 A front view of a clamping device and a part of an actuating device in a positioning device according to the present invention is shown. Figure 4 A stereoscopic view of an actuating tool in a positioning device according to the present invention is shown. The actuating device 20 includes a rotating component 21 and an actuating tool 22. The rotating component 21 includes a threaded portion 211, an operating portion 212 and a pressurizing portion 213. The threaded portion 211 has an external thread, which cooperates with a threaded hole in a clamping portion, so that when the threaded portion 211 is rotated in the threaded hole by rotating the operating portion 212 preferably located at one end of the threaded portion 211, the rotating component 21 rotates while moving along its own axis. A pressurizing portion 213 is provided at the end of the threaded portion 211 opposite to the operating portion 212. When the rotating component 21 moves along its own axis, the pressurizing portion 213 can contact a portion of a holding device 40 to be described below, thereby applying a clamping force thereto, so as to facilitate the fixation of the clamping device to the patient's bone.

[0048] The actuator 20 also includes Figure 4The actuating tool 22 shown in FIG. The body 221 of the actuating tool 22 has an operating hole 222 at one section, and the operating hole 222 can cooperate with the operating portion 212 of the rotating component 21, so that the rotating component 21 can be rotated by rotating the actuating tool 22. As a specific embodiment, the operating portion 212 adopts a prism structure, for example, it can be a quadrangular prism; accordingly, the operating hole 222 can adopt a square hole to cooperate with the prism structure. Of course, those skilled in the art understand that the shapes of the operating hole 222 and the operating portion 212 do not have to be completely matched, as long as the two can be able to rotate together in the circumferential direction.

[0049] The body 221 of the actuating tool is also provided with a threaded hole inside so as to engage with the external thread of the threaded portion 211 of the rotating component 21. Figure 3 It can be known that during use, the rotating part 21 can be rotated by rotating the actuating tool by using the shape of the operating hole 222 and the operating part 212. As the rotating part 21 rotates, it starts to apply force to the holding device along its own axial direction, so that the clamping device clamps the corresponding part of the patient. After clamping, the threaded hole of the body 221 can be connected to the rotating part 21, and the actuating tool 22 moves along the rotating part 21 to the clamping part through threaded engagement, and finally abuts the first surface of the locator 10, thereby achieving compression between the locator, the adjustment device and the clamping device. When the operation is completed or the positioning device needs to be removed, the actuating tool 22 can be unscrewed from the rotating part 21, and then the operating hole 222 is used to cooperate with the operating part 212 to achieve the opening of the clamping device. Thus, two functions are achieved through the actuating tool 22.

[0050] The structure of the clamping device 40 is described in detail below. Figure 3 The clamping device 40 includes a first part 41 and a second part 42, and the two parts can rotate relative to each other. The first part 41 includes a first clamping portion 411 and a pressure-receiving portion 412 located at one end of the clamping portion 411. The second part 42 includes a second clamping portion 422 and a connecting portion 421. The first part 41 and the second part 42 can rotate relative to each other, for example, by a hinge. When the rotating component 21 moves downward, the pressurizing portion 213 begins to contact the pressure-receiving portion 412 and begins to apply pressure to the latter, thereby causing the first part 41 to rotate relative to the second part 42, thereby the first clamping portion 411 and the second clamping portion 422 approach each other, thereby clamping the patient's part located therein.

[0051] As a preferred embodiment, the pressurizing portion 213 is tapered and thus has a tapered surface. The pressurized portion 412 has a surface that matches the tapered surface. Thus, when the rotating component 21 moves downward, the pressurizing portion 213 applies a force to the pressurized portion 412 downward to the right, thereby driving the first portion 41 to rotate around the rotation axis.

[0052] In order to optimize the force, preferably, the force arm of the moment borne by the pressure portion 412 is substantially equal to the force arm of the first clamping portion 411 when the first clamping portion 411 and the second clamping portion 422 clamp the bone together.

[0053] The connecting portion 421 is generally plate-shaped and connected to the second clamping portion 422. A threaded hole is provided in the connecting portion 421 to match the threaded portion 211. Preferably, the material of the portion where the second clamping portion 422 and the connecting portion 421 are connected is thickened to increase its strength and prevent the clamping device from being damaged due to excessive force, such as cracks or disconnection.

[0054] As a preferred embodiment of the present invention, the first clamping portion 411 and the second clamping portion 422 have clamping surfaces facing each other, and a plurality of sharp portions, such as conical sharp teeth, are respectively arranged on the respective clamping surfaces. For example, 3×2 sharp portions are respectively arranged on each clamping surface, and the sharp portions on the two clamping surfaces are arranged alternately.

[0055] As a further improvement, when the clamping device is in the clamping state, the two clamping surfaces are not parallel to each other, but at a certain angle. Thus, the clamping device can clamp different physiological and anatomical structures of the spinous processes of the cervical vertebra and the thoracolumbar vertebra, especially the spinous processes of the cervical vertebra are narrow at the top and wide at the bottom. For example, when in the clamping state, the distance between the two clamping surfaces at the part away from the rotating axis of the clamping part can be smaller than the distance at the part close to the rotating axis of the clamping part.

[0056] As can be seen from the above, the positioning device proposed in the present invention forms a stable connection with the patient's bone. During the manual registration process, the calibration points scanned by the image scanning device can be quickly identified, and the navigation probe can be used to quickly touch and calibrate these calibration points. Compared with the traditional manual registration process, the registration time is greatly reduced, the patient's exposure time is reduced, and the probability of infection is reduced. At the same time, the degree of standardization of the manual registration process is improved, the operation process is simplified, and the surgeon can find the registration calibration points more quickly and accurately, which improves the registration accuracy, that is, improves the navigation accuracy and surgical success rate of subsequent navigation surgery.

[0057] For those skilled in the art, various modifications and variations may be made to the embodiments disclosed above without departing from the scope or spirit of the present invention. Other embodiments of the present invention will be apparent to those skilled in the art from the practice of the present invention disclosed in this specification. This specification and the examples disclosed therein should be considered to be illustrative only, and the true scope of the present invention is specified by the appended claims and their equivalents.

Claims

1. A locator, characterized in that: include: A main body part (11), which is in a plate shape and has a first surface and a second surface; A positioning column (12) extends from the first surface and has a first hole (121) and a second hole (122) connected to each other, and the diameter of the first hole is greater than the diameter of the second hole.

2. The positioner according to claim 1, characterized in that The main body portion has an adjustment path (112) extending through the first surface and the second surface, the adjustment path being located within an outer contour of the main body portion.

3. The positioner according to claim 2, characterized in that Viewed in a direction perpendicular to the first surface or the second surface, the adjustment path is formed by a straight line or an arc or a combination of the two.

4. The positioner according to any one of claims 1 to 3, characterized in that: The portion of the main body corresponding to the first hole of the positioning column has a hole penetrating the first surface and the second surface, a metal element is arranged in the first hole and is inserted through the hole of the main body, and the metal element is tightly matched with the first hole; and / or the second hole is an elongated hole; Preferably, the main body is made of plastic, and a positioning pin made of metal is also provided in the main body.

5. The positioner according to any one of claims 1 to 3, characterized in that: The main body portion and the positioning posts are integrally formed; and / or the number of the positioning posts is 8, 9 or 10.

6. The positioner according to any one of claims 1 to 3, characterized in that: The outer contour of the positioner is provided with at least one recess (111).

7. A positioning device, characterized in that: include: A positioner (10) according to any one of claims 1 to 6; An actuating device (20) having a rotating component (21); A clamping device (40) having a first portion (41) and a second portion (42), wherein the clamping device is located on one side of the positioner; The rotating member passes through the positioner and one end thereof can apply a force to the first portion so that the first portion and the second portion rotate relative to each other.

8. The positioning device according to claim 7, characterized in that: The first part includes a first clamping portion (411) and a pressure receiving portion (412); The second portion includes a connecting portion (412) and a second clamping portion (422); Preferably, when the first clamping portion and the second clamping portion are in a clamping state, the clamping surfaces of the first clamping portion and the second clamping portion are at an angle, and preferably the distance between the clamping surfaces of each clamping portion at a portion away from the rotation axis of the clamping portion is smaller than the distance between the clamping surfaces at a portion close to the rotation axis of the clamping portion; Preferably, each clamping surface has a plurality of sharp portions, and the sharp portions on the two clamping surfaces are arranged alternately.

9. The positioning device according to claim 8, characterized in that: The rotating component comprises a threaded portion (211), an operating portion (212) and a pressurizing portion (213), wherein the threaded portion has an external thread and cooperates with the threaded hole on the connecting portion, and the pressurizing portion can cooperate with the pressurized portion of the first portion, and the pressurizing portion is preferably conical; Preferably, when the first clamping portion and the second clamping portion are in a clamping state, the force arm of the moment borne by the pressure-bearing portion is substantially equal to the force arm of the first clamping portion.

10. The positioning device according to claim 9, characterized in that: The actuating device further comprises an actuating tool (22), wherein the actuating tool has an operating hole (222), wherein the operating hole is used to actuate the operating part so as to cause the rotating part to rotate and move along its own axis; preferably, the operating hole is square and the operating part is also square.

11. The positioning device according to any one of claims 7 to 10, characterized in that: It also comprises an adjusting device (30) which is arranged between the positioner and the clamping device and is used for adjusting the positioner in a direction perpendicular to the first surface.

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