Pre-positioning assembly, navigation device and bone channel establishing system

Abstract

According to the pre-positioning assembly, a first positioning component is provided with a first positioning channel with the two ends penetrating through, the first positioning channel is used for allowing a drilling assembly to penetrate through, a second positioning component is provided with a second positioning channel with the two ends penetrating through, and the first positioning component is movably sleeved with the second positioning component through the second positioning channel of the second positioning component; the first positioning channel is provided with a channel reference track line, the second positioning component moves along the channel reference track line relative to the first positioning component and is used for driving the drilling assembly to move synchronously, and the limiting component is arranged on the first positioning component and is used for limiting the maximum movement distance of the second positioning component moving along the channel reference track line. Through cooperation of the first positioning part, the second positioning part and the limiting part, the maximum drilling depth can be limited, the problems that in the tentative drilling process, the drilling depth cannot be accurately mastered, and bone cortex is punctured are solved, body injuries to a patient are avoided, and the operation danger is reduced.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a pre-positioning component, a navigation device, and a bone channel establishment system. Background Art

[0002] In related orthopedic surgeries, before implanting screws and other implants in the body, it is usually necessary to establish an implantation channel in advance. The surgeon generally establishes the implantation channel based on the surgeon's own clinical surgical experience and performs tentative implantation in reference to the general direction of the medical anatomical structure. It is conceivable that the clinical surgical experience of different surgeons varies greatly, and the exploratory implantation method further increases the gap in surgical results. Therefore, the risk of misplacement of implants in the body is usually at a high level, especially in some complex anatomical locations in the body. If the implantation depth is not well controlled, it is easy to puncture the bone cortex, causing physical damage to the patient and posing surgical risks. Summary of the invention

[0003] Based on this, it is necessary to provide a pre-positioning component, a navigation device and a bone channel establishment system to address the technical issues of risks in establishing the implant channel mentioned above.

[0004] The present application provides a pre-positioning component, the pre-positioning component comprising:

[0005] A first positioning component, wherein the first positioning component has a first positioning channel with two ends extending therethrough, and the first positioning channel is used for penetrating a drilling assembly;

[0006] a second positioning component, wherein the second positioning component has a second positioning channel with two ends extending therethrough, the second positioning component is movably sleeved on the outside of the first positioning component by using the second positioning channel thereof, the first positioning channel has a channel reference trajectory line, the second positioning component moves relative to the first positioning component along the channel reference trajectory line, and is used to drive the drilling assembly to move synchronously;

[0007] A limiting component is used to be connected to the first positioning component to limit the maximum movement distance of the second positioning component along the channel reference trajectory line.

[0008] In one embodiment, the limiting component is assembled on the first positioning component through a positioning assembly mechanism, the positioning assembly mechanism is used to adjust the assembly position of the limiting component on the first positioning component, and the assembly position of the limiting component on the first positioning component is used to adjust the maximum movement distance; and / or,

[0009] An elastic component is arranged between the first positioning component and the second positioning component, and the elastic force generated by the elastic component is used to drive the second positioning component to move along the channel reference trajectory line in a direction away from the limiting component; and / or,

[0010] The distal end of the first positioning component is provided with an end positioning structure; and / or,

[0011] At least one of the first positioning member and the second positioning member is a sleeve; and / or,

[0012] The channel reference trajectory is a straight trajectory or a curved trajectory.

[0013] In one embodiment, the pre-positioning component comprises:

[0014] a position sensor device, the position sensor device being used to obtain position data of the drilling assembly; and / or,

[0015] a displacement sensor device, the displacement sensor device being used to obtain displacement data of the drilling assembly; and / or,

[0016] The deflection angle sensor device is used to obtain at least one of the angle data and the direction data of the drilling assembly.

[0017] In one embodiment, the position sensor device includes:

[0018] A first electrical contact element, the first electrical contact element is arranged on the first positioning component for electrically contacting the drilling assembly; and / or,

[0019] A second electrical contact element is disposed on the second positioning component and is used for making electrical contact with the drilling assembly.

[0020] In one embodiment, the displacement sensor device includes at least one of a capacitive displacement sensor, an inductive displacement sensor, a photoelectric encoding displacement sensor, a wire displacement sensor, a magnetic Hall displacement sensor, and a magnetostrictive displacement sensor; and / or,

[0021] The deflection angle sensor device is a six-axis sensor.

[0022] In one embodiment, the displacement sensor device includes a resistance track and a conductive element, and the conductive element moves along the resistance track in a conductive manner;

[0023] The resistance track and the conductive element are located at the first positioning component and the second positioning component respectively; or the resistance track and the conductive element are located at the first positioning component and the drilling component respectively.

[0024] The present application also provides a navigation device, characterized in that the navigation device comprises:

[0025] the pre-positioning component;

[0026] A holding component is connected to the pre-positioning component.

[0027] In one embodiment, the navigation device comprises:

[0028] A drilling assembly is movably arranged in the first positioning channel of the pre-positioning assembly, and the drilling assembly moves synchronously with the second positioning component of the pre-positioning assembly.

[0029] In one embodiment, the drilling assembly comprises:

[0030] Drilling elements;

[0031] A transfer element, the transfer element being connected to the drilling element and used for transfer to a driving device;

[0032] An electrode element is provided on the drilling element. There are a plurality of electrode elements, and the plurality of electrode elements are insulated and isolated from each other.

[0033] In one embodiment, at least one of the electrode elements is used to electrically connect to a first electrical contact element of the pre-positioning component, and at least another electrode element is used to electrically connect to a second electrical contact element of the pre-positioning component; and / or,

[0034] An insulating element is provided between the drilling element and the adapter element; and / or,

[0035] The distal end of the drilling element is configured as an end drilling structure.

[0036] In one embodiment, the holding assembly is connected to the first positioning component of the pre-positioning assembly; and / or,

[0037] The pre-positioning assembly is provided with a cantilever element and a supporting element, one end of the cantilever element is connected to the first positioning component, and the other end of the cantilever element is connected to the supporting element, and the supporting element is used to assemble the holding assembly.

[0038] In one embodiment, the holding assembly includes a holding part and a main control circuit board located in the holding part, and the main control circuit board is used to be electrically connected to at least one of the position sensor device, the displacement sensor device and the deflection sensor device of the pre-positioning assembly;

[0039] And / or, the cantilever element is a linear cantilever, the first positioning component is a linear sleeve, and the angle between the cantilever element and the first positioning component is less than 60°.

[0040] In one embodiment, the holding assembly includes a switch device, and the switch device is electrically connected to the main control circuit board; and / or,

[0041] The main control circuit board includes at least one of a power supply control unit, a position measurement unit, a displacement measurement unit, an angle measurement unit, a signal processing unit, a warning unit and a wireless transmission unit.

[0042] The present application also provides a bone channel establishment system, characterized in that the bone channel establishment system comprises: the pre-positioning component; or, the navigation device.

[0043] In the above-mentioned pre-positioning component, navigation device and bone channel establishment system, after the second positioning component moves a certain distance along the channel reference trajectory line, the second positioning component will form a limiting contact with the limiting component. After the two are in contact, the second positioning component cannot continue to move, and the drilling component will also stop moving. The distance moved by the second positioning component and the drilling component at this time is the maximum movement distance limited by the limiting component to move along the channel reference trajectory line. The maximum movement distance is expressed as the maximum depth of drilling the target object. Through the cooperation between the first positioning component, the second positioning component and the limiting component, the maximum depth of drilling can be limited to prevent the inability to accurately grasp the drilling depth during the trial drilling process, puncture the bone cortex and other problems, avoid physical damage to the patient, and reduce the risk of surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Figure 1 A schematic diagram of the structure of a navigation device provided in one embodiment of the present application.

[0045] Figure 2 An exploded schematic diagram of a navigation device provided by one embodiment of the present application.

[0046] Figure 3 A schematic diagram of the structure of a pre-positioning component provided for one embodiment of the present application.

[0047] Figure 4 A schematic structural diagram of a drilling assembly provided in one embodiment of the present application.

[0048] Figure 5 An exploded schematic diagram of a drilling assembly provided for one embodiment of the present application.

[0049] Figure 6 A schematic diagram of the structure of a holding assembly provided in one embodiment of the present application.

[0050] Figure 7 A schematic cross-sectional view of a gripping assembly AA provided in accordance with an embodiment of the present application.

[0051] Figures 8a to 8d A schematic diagram of the movement process of a navigation device provided by an embodiment of the present application.

[0052] Fig. 9 A partial schematic diagram of the circuit connection structure of a position sensor device and a displacement sensor device provided in one embodiment of the present application.

[0053] Fig.10 A schematic diagram of the circuit unit connection structure of a main control circuit board provided in one embodiment of the present application.

[0054] Figure Number:

[0055] 1000, pre-positioning assembly; 2000, drilling assembly; 3000, holding assembly;

[0056] 1100, first positioning component; 1200, second positioning component; 1300, limiting component;

[0057] 1100a, channel reference trajectory line; 1100b, positioning assembly mechanism; 1100c, end positioning structure;

[0058] 1100a1, first electrical contact element; 1100a2, second electrical contact element; 1100b1, resistor track; 1100b2, conductive element;

[0059] 2100, drilling element; 2200, switching element; 2300, insulating element;

[0060] 2100a, end drilling structure;

[0061] 3000a, cantilever element; 3000b, supporting element;

[0062] 3100, holding component; 3200, main control circuit board;

[0063] 3200a, power supply control unit; 3200b, position measurement unit; 3200c, displacement measurement unit; 3200d, deflection measurement unit; 3200e, signal processing unit; 3200f, warning unit; 3200g, wireless transmission unit. DETAILED DESCRIPTION

[0064] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0065] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0066] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0067] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0068] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0069] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0070] In order to more clearly describe the structure of the delivery device, the term "distal end" is defined herein to mean the end away from the operator during the surgical operation, and the term "proximal end" is defined herein to mean the end close to the operator during the surgical operation. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as those commonly understood by those skilled in the art to which this application belongs. The terms used in this specification are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0071] See also Figures 1 to 10 As shown, the present application discloses a pre-positioning component 1000 and a navigation device including the pre-positioning component 1000. Specifically, the navigation device includes the pre-positioning component 1000 and a holding component 3000, wherein the holding component 3000 is connected to the pre-positioning component 1000, and the holding component 3000 is used for the operator to hold and control the pre-positioning component 1000. Therefore, the shape of the holding component 3000 and the connection angle and direction between the holding component 3000 and the pre-positioning component 1000 can be designed to facilitate the operator's control. Those skilled in the art can set it according to the needs, and there is no limitation on this. Please continue to refer to Figure 4 and Figure 5As shown, in one embodiment, the navigation device includes a drilling component 2000, which is a component for directly performing a drilling operation on a target object. The drilling component 2000 is movably arranged in the first positioning channel of the pre-positioning component 1000, and the drilling component 2000 and the second positioning component 1200 of the pre-positioning component 1000 can move synchronously. Therefore, when the second positioning component 1200 moves relative to the first positioning component 1100, the second positioning component 1200 can drive the drilling component 2000 to move synchronously, so that the drilling component 2000 can move in the first positioning channel of the first positioning component 1100 along the channel reference trajectory line 1100a. The following will be described in detail.

[0072] See also Figures 1 to 7 ,as well as Figures 8a to 8d As shown, the pre-positioning component 1000 can be applied to a navigation device used in a drilling operation, as a matching structure for pre-positioning the drilling in the navigation device. Among them, the pre-positioning component 1000 includes a first positioning component 1100, a second positioning component 1200 and a limiting component 1300. The first positioning component 1100 has a first positioning channel with two ends passing through, and the first positioning channel is used to pass through the drilling component 2000. The second positioning component 1200 has a second positioning channel with two ends passing through. The second positioning component 1200 uses its second positioning channel to flexibly cover the outside of the first positioning component 1100. The first positioning channel has a channel reference trajectory line 1100a. The second positioning component 1200 moves relative to the first positioning component 1100 along the channel reference trajectory line 1100a. During the movement of the second positioning component 1200, it is used to drive the drilling component 2000 to move synchronously along the channel reference trajectory line 1100a relative to the first positioning component 1100. The limiting component 1300 is set on the first positioning component 1100, and the limiting component 1300 is used to limit the maximum movement distance of the second positioning component 1200 along the channel reference trajectory line 1100a.

[0073] The first positioning component 1100 and the second positioning component 1200 can adopt an outer shape structure that is convenient for drilling. For example, the first positioning component 1100 and the second positioning component 1200 can be selected as sleeves according to needs, such as cylindrical sleeves, prismatic sleeves, etc., which are not limited here. With the help of the first positioning channel with two ends through formed in the first positioning component 1100, the drilling assembly 2000 can be movably assembled in the first positioning channel. With the help of the second positioning channel with two ends through formed in the second positioning component 1200, the first positioning component 1100 can be movably assembled in the second positioning channel, wherein the channel reference trajectory line 1100a is the channel extension trajectory of the first positioning channel, such as the central axis of the first positioning channel. The first positioning channel can be selected as a straight trajectory or a curved trajectory according to needs. Therefore, the channel reference trajectory line 1100a can also be constructed as a straight trajectory or a curved trajectory. Those skilled in the art can design it according to actual needs, which is not limited.

[0074] The movement of the second positioning component 1200 can be limited to movement along the channel reference trajectory line 1100a. When the second positioning component 1200 is connected to the drilling assembly 2000, the second positioning component 1200 moves along the channel reference trajectory line 1100a and can drive the drilling assembly 2000 to move synchronously along the channel reference trajectory line 1100a. When drilling a target object (such as human bone tissue), the distal end of the first positioning component 1100 will be positioned and contacted on the target object, wherein the distal end of the first positioning component 1100 can be provided with an end positioning structure 1100c, such as a cutting edge or an irregular port structure that increases the contact friction. After the two are positioned and contacted, the second positioning component 1200 will move along the channel reference trajectory line 1100a on the first positioning component 1100, and then synchronously drive the drilling component 2000 to move in the first positioning channel. As the drilling component 2000 continues to move toward the distal end in the first positioning channel, the drilling component 2000 will be exposed from the distal end of the first positioning channel to the outside of the first positioning component 1100, and when the drilling component 2000 comes into contact with the target object, it starts to drill the target object.

[0075] As the length of the drilling assembly 2000 exposed from the far end of the first positioning channel increases, the depth of the drilling of the target object by the drilling assembly 2000 also increases. The distance of movement of the drilling assembly 2000 calculated from the far end of the first positioning channel is equivalent to the depth of the drilling. If the drilling assembly 2000 is arranged in the first positioning channel and the far end of the drilling assembly 2000 is flush with the far end of the first positioning channel, the drilling assembly 2000 is exposed from the far end of the first positioning channel as soon as it starts to move. Therefore, the actual movement distance of the drilling assembly 2000 is equivalent to the depth of the drilling. Those skilled in the art can select the assembly method of the drilling assembly 2000 in the first positioning channel and the method for calculating the drilling depth according to actual needs, and there is no limitation on this.

[0076] Since the first positioning component 1100 is provided with a limiting component 1300, after the second positioning component 1200 moves a certain distance along the channel reference trajectory line 1100a, the second positioning component 1200 will form a limiting contact with the limiting component 1300. After the two are in limiting contact, the second positioning component 1200 cannot continue to move, and the drilling assembly 2000 will also stop moving synchronously. The distance moved by the second positioning component 1200 and the drilling assembly 2000 at this time is the maximum movement distance limited by the limiting component 1300 to move along the channel reference trajectory line 1100a. The maximum movement distance is expressed as the maximum depth that can be drilled into the target object. Therefore, through the cooperation between the first positioning component 1100, the second positioning component 1200 and the limiting component 1300, the maximum drilling depth can be limited, so as to prevent the failure to accurately grasp the drilling depth during the trial drilling process, and to prevent the occurrence of problems such as puncturing the bone cortex, thereby avoiding physical injuries to the patient and reducing the risk of surgery.

[0077] The maximum movement distance of the second positioning component 1200 and the drilling assembly 2000 along the channel reference trajectory line 1100a can be adjusted according to needs. For example, in one embodiment, refer to Figure 3As shown, the limiting component 1300 is assembled on the first positioning component 1100 through the positioning assembly mechanism 1100b, and the positioning assembly mechanism 1100b is used to adjust the assembly position of the limiting component 1300 on the first positioning component 1100, and the assembly position of the limiting component 1300 on the first positioning component 1100 is used to adjust the maximum movement distance. Among them, the positioning assembly mechanism 1100b can be a snap connection structure, a threaded connection structure, an adhesive structure, and other structures that can adjust the assembly position of the limiting component 1300 on the first positioning component 1100. For example, the positioning assembly mechanism 1100b can include an external thread on the first positioning component 1100 and a threaded hole on the limiting component 1300. When the limiting component 1300 is connected to the external thread on the first positioning component 1100 through the threaded hole, the limiting component 1300 can adjust its own assembly position on the first positioning component 1100 by means of threads. Those skilled in the art can select other structures according to needs, and this is not limited.

[0078] The movement of the second positioning member 1200 on the first positioning member 1100 includes movement in the distal direction (eg Figure 1 downward as shown) and in a proximal direction (as shown Figure 1 When the second positioning component 1200 is controlled to move toward the distal direction, the drilling assembly 2000 is controlled to perform the drilling operation. When the drilling operation is completed, the second positioning component 1200 moves toward the proximal direction. Among them, an elastic component, such as a spring, a spring sheet, or the like, can be provided between the first positioning component 1100 and the second positioning component 1200, so that the elastic force generated by the elastic component can assist the movement of the second positioning component 1200 on the first positioning component 1100. For example, the elastic force generated by the elastic component can be used to drive the second positioning component 1200 to move along the channel reference trajectory line 1100a in the direction away from the limiting component 1300. Therefore, when the drilling operation is completed, the operator does not need to manually reset the second positioning component 1200. The second positioning component 1200 will automatically reset by the elastic force.

[0079] See also Figures 8a to 8d As shown, Figure 8a , Figure 8b , Figure 8c , Figure 8d The process of the second positioning component 1200 moving toward the distal end and resetting toward the proximal end is shown in sequence. The operator can adjust the limiting component 1300 to a suitable position to limit the maximum movement distance. Figure 8aAs shown, the position of the limiting component 1300 can be determined first. The determination of this position can predetermine the maximum movement distance of the second positioning component 1200 toward the distal end, which is equivalent to determining the maximum movement distance of the drilling assembly 2000. The maximum movement distance can be used to measure the maximum drilling depth. The position of the limiting component 1300 is determined. Figure 8b As shown, the operator applies a force F to press the drilling assembly 2000, as shown in FIG. Figure 8b As shown in FIG. 8c, the second positioning member 1200 moves downward until it contacts the limiting member 1300 and stops. Figure 8d As shown, when the force F is removed, the second positioning component 1200 elastically returns to the initial position.

[0080] In addition to limiting the maximum drilling depth by the limiting component 1300, the pre-positioning component 1000 can also obtain the position data of the drilling component 2000 in the target environment (such as the human tissue environment, where the human bone tissue is located in the target environment), obtain the depth data of the drilling component 2000 in the target object, and obtain the real-time angle data and direction data of the drilling component 2000. These data are fed back to the operator, which can help the operator to operate accurately during the drilling operation and improve the success rate of the operation. In one embodiment, the pre-positioning component 1000 includes a position sensor, a displacement sensor, and an angle sensor, etc. The position sensor is used to obtain the position data of the drilling component 2000 in the body during the drilling process, the displacement sensor is used to obtain the displacement data of the drilling component 2000, and the angle sensor is used to obtain at least one of the angle data and the direction data of the drilling component 2000.

[0081] The position sensor can collect position data using a variety of principles. In one embodiment, the position sensor device includes a first electrical contact element 1100a1 and a second electrical contact element 1100a2. The first electrical contact element 1100a1 is disposed on the first positioning component 1100, and the second electrical contact element 1100a2 is disposed on the second positioning component 1200. The first electrical contact element 1100a1 is used to make electrical contact with the drilling component 2000, and the second electrical contact element 1100a2 is used to make electrical contact with the drilling component 2000. The first electrical contact element 1100a1 and the second electrical contact element 1100a2 are only part of the components in the position sensor device. The position sensor device also includes a plurality of electrode elements on the drilling component 2000, and a main control circuit board 3200 for data processing. Among them, those skilled in the art can select the specific arrangement positions of the first electrical contact element 1100a1 and the second electrical contact element 1100a2 according to needs, which are not limited to the pre-positioning component 1000 or the drilling component 2000.

[0082] The principle of obtaining the position data of the drilling component 2000 in the body during the drilling process is as follows: the human cortical bone, cancellous bone, blood, muscle and other human tissues have different bioelectrical impedances. When the distal end of the drilling component 2000 enters the human bone tissue or other tissues, different parts will generate different resistances, and the current values ​​formed in the loop are different. Therefore, after signal processing, the position data can be generated. The position data can, for example, indicate that the drilling component 2000 is located at different positions such as cortical bone, cancellous bone, blood and muscle. Fig. 9 As shown, the first electrical contact element 1100a1 and the second electrical contact element 1100a2 are electrically connected to the main control circuit board 3200, and different electrode elements on the drilling component 2000 are electrically connected to the first electrical contact element 1100a1 and the second electrical contact element 1100a2. Finally, a circuit can be formed by making contact with different positions of human tissue through the drilling component 2000.

[0083] The displacement sensor can collect displacement data using a variety of principles. For example, the displacement sensor device includes at least one of a capacitive displacement sensor, an inductive displacement sensor, a photoelectric encoding displacement sensor, a wire displacement sensor, a magnetic Hall displacement sensor, and a magnetostrictive displacement sensor. In one embodiment, continue to refer to Figure 8b , Figure 8c as well as Fig. 9 As shown, the displacement sensor device includes a resistor track 1100b1 and a conductive element 1100b2, and the conductive element 1100b2 moves along the resistor track 1100b1 in a conductive manner.

[0084] The principle of obtaining displacement data is as follows: the near end of the resistance track 1100b1 (i.e. Fig. 9 The resistance between the conductive element 1100b2 and the conductive element 1100b2 is the maximum value R. When the second positioning component 1200 is directed toward the distal end (i.e. Fig. 9 When the conductive element 1100b2 moves toward the distal end (as shown in the figure), the position of the conductive connection between the conductive element 1100b2 and the resistor track 1100b1 changes. The total length of the resistor track 1100b1 is L, and the distance moved toward the distal end is L1. The resistance between the resistor track 1100b1 and the conductive element 1100b2 is R1. By calculating with the formula, L1=L(R-R1) / R, the movement distance of the conductive element 1100b2 relative to the resistor track 1100b1 toward the distal end can be obtained. The movement distance can be expressed as the movement distance of the drilling component 2000. If the distal end of the drilling component 2000 is flush with the distal end of the first positioning channel, the movement distance can directly represent the drilling depth of the drilling component 2000.

[0085] The resistance track 1100b1 and the conductive element 1100b2 may be located at the first positioning component 1100 and the second positioning component 1200, respectively. For example, the resistance track 1100b1 is located at the second positioning component 1200, and the conductive element 1100b2 is located at the first positioning component 1100. Alternatively, the resistance track 1100b1 and the conductive element 1100b2 may also be located at the first positioning component 1100 and the drilling assembly 2000, respectively, so that the movement distance calculated by the formula L1=L(R-R1) / R is directly the movement distance of the drilling assembly 2000. The resistance track 1100b1 may be formed by coating the inner wall of the second positioning channel with a conductive material or winding a conductive material, and the conductive element 1100b2 may be a brush or a conductive spring, etc., which is not limited thereto.

[0086] The deflection sensor can collect angle data and direction data using a variety of principles. For example, the deflection sensor device is a six-axis sensor. The principle of obtaining angle data and direction data is: when an object rotates in space, the angle and direction of the object can be represented by three angles, namely pitch angle, yaw angle and roll angle. The six-axis sensor can be used to measure pitch angle, yaw angle and roll angle. The six-axis sensor consists of two parts: an accelerometer and a gyroscope.

[0087] An accelerometer is a device that can measure the acceleration of an object. It works based on Newton's second law, which states that force equals mass times acceleration. When an accelerometer is placed on an object, it senses the force of gravity. When the object is stationary, the accelerometer measures the acceleration due to gravity and displays the value. When the object's acceleration changes, the accelerometer measures the total acceleration, which includes the acceleration due to gravity and the acceleration of the object's motion. By measuring the change in acceleration of the accelerometer on three axes, the direction of the object can be calculated.

[0088] A gyroscope is able to measure the angular velocity of an object. The working principle of a gyroscope is based on the law of conservation of angular momentum. When a gyroscope is placed on an object, it can sense the object's rotation speed on each axis. By measuring the change in the rotation speed of the gyroscope on the three axes, the object's rotation angle can be calculated.

[0089] The measurement results of the accelerometer and gyroscope have noise and errors, but after calculation using algorithms such as the Kalman filter algorithm, the measured data can be fused with prior information to obtain accurate angle data and direction data. The pitch angle, yaw angle, and roll angle can be used as calculation parameters, and the angle with the horizontal plane can be calculated using the following formula:

[0090] Angle = arctan (tan (pitch angle) / cos (roll angle)).

[0091] The drilling component 2000 can adopt a variety of structures. For example, the drilling component 2000 includes a drilling component 2100, a transfer component 2200 and an electrode component. The electrode component is arranged on the drilling component 2100. There are multiple electrode components, and the multiple electrode components are insulated and isolated. Among them, the electrode component is mainly used to electrically connect with the first electrical contact component 1100a1 and the second electrical contact component 1100a2 in the pre-positioning component 1000, and together constitute a part of the position sensor, which is used to obtain position data. The transfer component 2200 is connected to the drilling component 2100. The transfer component 2200 can adopt a common drill bit clamping structure that is easy to transfer to a driving device such as an electric drill, so that the drilling component 2000 can be transferred to the electric drill during the drilling operation, and the electric drill is used to control the rotation of the drilling component 2000 (mainly the drilling component 2100), so as to meet the coordination of the electric drill and the navigation device.

[0092] The electrode element is electrically connected to the first electrical contact element 1100a1 and the second electrical contact element 1100a2, and needs to maintain good electrical contact during the rotation of the drilling element 2100. For example, the first electrical contact element 1100a1 and the second electrical contact element 1100a2 are circular ring structures or other structures that can meet the requirements of electrical connection during rotation. Those skilled in the art can choose according to their needs and are not limited to this. In one embodiment, at least one electrode element is used to electrically connect to the first electrical contact element 1100a1 of the pre-positioning component 1000, and at least another electrode element is used to electrically connect to the second electrical contact element 1100a2 of the pre-positioning component 1000. An insulating element 2300 is provided between the drilling element 2100 and the adapter element 2200, and the insulating element 2300 can insulate and isolate the drilling element 2100 and the adapter element 2200, wherein at least one electrode element can extend through the insulating element 2300 to the proximal position of the pre-positioning component 1000, and the remaining electrode elements are located at the distal end of the pre-positioning component 1000, thereby constructing a proximal electrode and a distal electrode on the pre-positioning component 1000, and the proximal electrode and the distal electrode are respectively used to facilitate the connection of the first electrical contact element 1100a1 of the first positioning component 1100 and the second electrical contact element 1100a2 of the second positioning component 1200. The distal end of the drilling element 2100 is provided with an end drilling structure 2100a, and the end drilling structure 2100a can be designed to have different sizes according to requirements to match different drilling sizes, and there is no limitation on this.

[0093] In one embodiment, the holding assembly 3000 is connected to the first positioning component 1100 of the pre-positioning assembly 1000. The pre-positioning assembly 1000 may be connected with a cantilever element 3000a and a support element 3000b, one end of the cantilever element 3000a is connected to the first positioning component 1100, and the other end of the cantilever element 3000a is connected to the support element 3000b, and the support element 3000b is used to assemble the holding assembly 3000. The cantilever element 3000a can be a linear cantilever, and the first positioning component 1100 can be a linear sleeve. The angle between the cantilever element 3000a and the first positioning component 1100 can be less than 60°, which is beneficial for the operator to hold and apply force, and better stabilize the pre-positioning component 1000. For example, the angle between the cantilever element 3000a and the first positioning component 1100 is 30°, 35°, 40°, 45°, 50°, 55°, 60°, etc., and there is no limitation on this.

[0094] Among them, the cantilever element 3000a and the support element 3000b can be pre-fixed on the pre-positioning component 1000, and belong to a part of the pre-positioning component 1000. For example, the cantilever element 3000a, the support element 3000b and the pre-positioning component 1000 are integrally formed, or are fixed by welding or other connection methods, and are used as a structural basis for assembling the holding component 3000, so that the holding component 3000 can be directly assembled with the pre-positioning component 1000 through the cantilever element 3000a and the support element 3000b when it is used. Alternatively, the cantilever element 3000a and the support element 3000b can also belong to a part of the holding component 3000, and the cantilever element 3000a can be pre-connected with the pre-positioning component 1000 by snap-fitting, plug-in, threaded connection, etc., and then the support element 3000b is used as the assembly basis of the holding component 3000, and the holding component 3000 is indirectly assembled on the pre-positioning component 1000. Those skilled in the art can select a suitable method according to their needs, which is not limited here.

[0095] In one embodiment, the holding component 3000 includes a holding part 3100 and a main control circuit board 3200 located in the holding part 3100, and the main control circuit board 3200 is used to electrically connect with at least one of the position sensor, displacement sensor and deflection sensor of the pre-positioning component 1000. Since the support element 3000b can be connected to the holding component 3000, the resistance track 1100b1 and the conductive element 1100b2 can be connected to the supporting element 3000b through wires, etc. When the holding component 3000 and the supporting element 3000b are assembled, the main control circuit board 3200 in the holding component 3000 can indirectly form an electrical connection with the resistance track 1100b1 and the conductive element 1100b2 by means of the supporting element 3000b. Similarly, the first electrical contact element 1100a1 and the second electrical contact element 1100a2 can also refer to the electrical connection method of the resistance track 1100b1 and the conductive element 1100b2, and be indirectly electrically connected to the main control circuit board 3200 by means of the support element 3000b. Those skilled in the art can select a suitable electrical connection method according to needs, and this is not limited.

[0096] The grip assembly 3000 includes a switch device, which is electrically connected to the main control circuit board 3200. The switch device can be used to control the switch of the main control circuit board 3200. Fig.10 As shown, the main control circuit board 3200 includes at least one of a power supply control unit 3200a, a position measurement unit 3200b, a displacement measurement unit 3200c, a deflection measurement unit 3200d, a signal processing unit 3200e, a warning unit 3200f and a wireless transmission unit 3200g. The power supply control unit 3200a can realize the conversion of the circuit voltage and the switch of the navigation device. The position measurement unit 3200b is used to measure the resistance between different electrode elements in the drill bit assembly to generate position data, for example, by measuring in an intermittent manner. The displacement measurement unit 3200c measures the drilling depth of the drill bit assembly to form displacement data. The deflection measurement unit 3200d measures the angle between the drilling assembly 2000 and the horizontal plane to form angle data and direction data. The signal processing unit 3200e is used to process data information such as position data, displacement data, angle data and direction data, and send it to the warning unit 3200f, and the warning unit 3200f is used to send a warning signal to the operator for reference. The warning unit 3200f can use signals that are easily perceived by humans, such as sound, light, screen display, and vibration, to promptly send out warning signals when an abnormal state occurs. The wireless transmission unit 3200g communicates with an external device and displays the current working status on the external device, thereby facilitating observation of the status of the device from other locations.

[0097] When drilling a hole in a bone is required, the switch device can be turned on first, the working status of the navigation device can be checked, the navigation device can be wirelessly connected to an external device through the wireless transmission unit 3200g, the holding component 3000 and the pre-positioning component 1000 can be assembled, and the limiting component 1300 in the pre-positioning component 1000 can be adjusted to set the maximum drilling depth. The distal end of the pre-positioning component 1000 is pressed on the bone to be drilled, and the displayed values ​​indicated by the angle data and the direction data are observed. The operator adjusts the required drilling angle according to the displayed values, and holds the holding component 3000 tightly to prevent the distal end of the pre-positioning component 1000 from moving. At this time, the pre-positioning before the implantation channel is established and the maximum drilling depth is limited. Then assemble the drilling component 2000 onto the electric drill and insert it into the first positioning channel of the pre-positioning component 1000. Turn on the electric drill to control the rotation of the drilling component 2000, perform the drilling operation, slowly advance and observe in real time whether the warning message prompted by the warning unit 3200f appears. If there is a warning message, stop the electric drill in time, adjust it and operate again.

[0098] Among them, the external device can be a tablet, mobile phone, console, etc. that can perform data control. Those skilled in the art can select a suitable control subject according to the actual use scenario and use requirements, which is not limited here. Moreover, when the cantilever element 3000a and the support element 3000b are pre-fixed on the pre-positioning component 1000 at a fixed angle, the holding component 3000 can be directly assembled on the support element 3000b, thereby realizing the assembly with the pre-positioning component 1000. If the cantilever element 3000a is pre-connected with the pre-positioning component 1000 by snap-fitting, plug-in, etc., the angle of the cantilever element 3000a relative to the pre-positioning component 1000 can be adjusted first, and then the support element 3000b is used as the assembly basis of the holding component 3000, and the holding component 3000 is assembled on the pre-positioning component 1000. Those skilled in the art can select a suitable method according to the needs, which is not limited here.

[0099] The present application also provides a bone channel establishment system, characterized in that the bone channel establishment system includes: a pre-positioning component 1000; or a navigation device. Since the technical scheme, functional principle and technical effect of the pre-positioning component 1000 and the navigation device are all described in detail in the previous text, they will not be repeated here. Any technical content related to the pre-positioning component 1000 and the navigation device can refer to the previous records.

[0100] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0101] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A pre-positioning component, characterized in that: The pre-positioning component comprises: A first positioning component, wherein the first positioning component has a first positioning channel with two ends extending therethrough, and the first positioning channel is used for penetrating a drilling assembly; a second positioning component, wherein the second positioning component has a second positioning channel with two ends extending therethrough, the second positioning component is movably sleeved on the outside of the first positioning component by using the second positioning channel thereof, the first positioning channel has a channel reference trajectory line, the second positioning component moves relative to the first positioning component along the channel reference trajectory line, and is used to drive the drilling assembly to move synchronously; A limiting component is used to be connected to the first positioning component to limit the maximum movement distance of the second positioning component along the channel reference trajectory line.

2. The pre-positioning assembly according to claim 1, characterized in that The limiting component is assembled on the first positioning component by a positioning assembly mechanism, the positioning assembly mechanism is used to adjust the assembly position of the limiting component on the first positioning component, and the assembly position of the limiting component on the first positioning component is used to adjust the maximum movement distance; and / or, An elastic component is arranged between the first positioning component and the second positioning component, and the elastic force generated by the elastic component is used to drive the second positioning component to move along the channel reference trajectory line in a direction away from the limiting component; and / or, The distal end of the first positioning component is provided with an end positioning structure; and / or, At least one of the first positioning member and the second positioning member is a sleeve; and / or, The channel reference trajectory is a straight trajectory or a curved trajectory.

3. The pre-positioning assembly according to claim 1, characterized in that: The pre-positioning component comprises: A position sensor device, the position sensor device is used to obtain the position data of the drilling assembly; and / or, a displacement sensor device, the displacement sensor device is used to obtain the displacement data of the drilling assembly; and / or, The deflection angle sensor device is used to obtain at least one of the angle data and the direction data of the drilling assembly.

4. The pre-positioning assembly according to claim 3, characterized in that: The position sensor device comprises: A first electrical contact element, the first electrical contact element is arranged on the first positioning component for electrically contacting the drilling assembly; and / or, A second electrical contact element is disposed on the second positioning component and is used for making electrical contact with the drilling assembly.

5. The pre-positioning assembly according to claim 3, characterized in that: The displacement sensor device includes at least one of a capacitive displacement sensor, an inductive displacement sensor, a photoelectric encoding displacement sensor, a wire displacement sensor, a magnetic Hall displacement sensor and a magnetostrictive displacement sensor; and / or, The deflection angle sensor device is a six-axis sensor.

6. The pre-positioning assembly according to claim 3, characterized in that: The displacement sensor device comprises a resistance track and a conductive element, and the conductive element moves along the resistance track in a conductive manner; The resistance track and the conductive element are located at the first positioning component and the second positioning component respectively; or the resistance track and the conductive element are located at the first positioning component and the drilling component respectively.

7. A navigation device, characterized in that: The navigation device comprises: The pre-positioning assembly according to any one of claims 1 to 6; A holding component is connected to the pre-positioning component.

8. The navigation device according to claim 7, characterized in that: The navigation device comprises: A drilling assembly is movably arranged in the first positioning channel of the pre-positioning assembly, and the drilling assembly moves synchronously with the second positioning component of the pre-positioning assembly.

9. The navigation device according to claim 8, characterized in that: The drilling assembly comprises: Drilling elements; A transfer element, the transfer element being connected to the drilling element and used for transfer to a driving device; An electrode element is provided on the drilling element. There are a plurality of electrode elements, and the plurality of electrode elements are insulated and isolated from each other.

10. The navigation device according to claim 9, characterized in that: At least one of the electrode elements is used to electrically connect to a first electrical contact element of the pre-positioning component, and at least another of the electrode elements is used to electrically connect to a second electrical contact element of the pre-positioning component; and / or, An insulating element is provided between the drilling element and the adapter element; and / or, The distal end of the drilling element is arranged as an end drilling structure.

11. The navigation device according to claim 7, characterized in that: The holding assembly is connected to the first positioning component of the pre-positioning assembly; and / or, The pre-positioning assembly is provided with a cantilever element and a supporting element, one end of the cantilever element is connected to the first positioning component, and the other end of the cantilever element is connected to the supporting element, and the supporting element is used to assemble the holding assembly.

12. The navigation device according to claim 11, characterized in that: The holding assembly comprises a holding part and a main control circuit board located in the holding part, wherein the main control circuit board is used to be electrically connected to at least one of the position sensor device, the displacement sensor device and the deflection angle sensor device of the pre-positioning assembly; And / or, the cantilever element is a linear cantilever, the first positioning component is a linear sleeve, and the angle between the cantilever element and the first positioning component is less than 60°.

13. The navigation device according to claim 12, characterized in that: The holding assembly includes a switch device, and the switch device is electrically connected to the main control circuit board; and / or, The main control circuit board includes at least one of a power supply control unit, a position measurement unit, a displacement measurement unit, an angle measurement unit, a signal processing unit, a warning unit and a wireless transmission unit.

14. A bone channel establishment system, characterized in that: The bone channel establishment system comprises: The pre-positioning component according to any one of claims 1 to 6; or A navigation device as claimed in any one of claims 7 to 13.

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