CN116887776A

CN116887776A - Medical navigation device, navigation processing device and method, and medical navigation system

Info

Publication number: CN116887776A
Application number: CN202280007392.7A
Authority: CN
Inventors: 徐晓龙; 郭楚; 何智圣; 陈德方; 张柳云; 刘梦星
Original assignee: Wuhan Mindray Technology Co Ltd
Current assignee: Wuhan Mindray Technology Co Ltd
Priority date: 2022-03-04
Filing date: 2022-11-09
Publication date: 2023-10-13
Also published as: CN219501199U; WO2023165158A1; CN116740309A; CN116887775A; CN116740309B; CN116687437A; WO2023165157A1

Abstract

The application discloses a medical navigation device and a navigation method thereof, wherein the medical navigation device comprises a navigation component and a developing and positioning component; the navigation component is provided with a sensor; the imaging positioning component is provided with a position mark which can be visually displayed in the medical image, and the navigation component is used for responding to a trigger instruction, recording reference position information when the sensor measured by the sensor is positioned at a reference position, acquiring real-time position information of the sensor in a state that the sensor is fixed with an orthopedic operation tool, acquiring first and/or second relative position information based on the real-time position information and prompting; the first relative position information is the relative position information between the real-time position and the reference position of the sensor; the second relative position information is the relative position information between the real-time position and the ideal nail feeding point of the intramedullary nail; the first relative position information, in combination with the target offset position information, and/or the second relative position information, may be used to guide the orthopaedic surgical tool to move to the desired intramedullary nail insertion point.

Description

Medical navigation device, navigation processing device and method, and medical navigation system

Technical Field

The present application relates to the field of medical technology, and more particularly, to a medical navigation apparatus, a navigation processing apparatus, a navigation method of the medical navigation apparatus, an electronic device, a computer-readable storage medium, a computer program product, and a medical navigation system.

Background

In clinical medical orthopaedics, some operations require the insertion of an orthopaedics operation tool or instrument, for example, proximal femur fracture (such as intertrochanteric fracture) or backbone fracture of tibia or humerus, and intramedullary nails are required to be inserted during the orthopaedics operation, and the bone fracture healing is facilitated by adopting an intramedullary nail fixing mode for treatment. When inserting the orthopedic tools or instruments, the specific insertion position and insertion direction of the orthopedic tools or instruments can affect the later surgical effect and the recovery effect after the surgery is finished.

Based on this, a technique to assist in determining the insertion position of an orthopedic surgical tool or instrument has emerged, however, the inventors have found that the conventional technique to assist in determining the insertion position of a tool or instrument has a problem in that the amount of radiation causing the surgical procedure is large.

Disclosure of Invention

In view of the above, the present application provides one or more of a medical navigation apparatus, a navigation processing apparatus, a navigation method of a medical navigation apparatus, an electronic device, a computer-readable storage medium, a computer program product, or a medical navigation system.

In a first aspect, the present application provides a medical navigation device for intramedullary nail insertion point navigation, comprising a navigation assembly and a visualization positioning assembly, the navigation assembly being provided with a sensor;

the developing and positioning assembly is provided with a position mark which can be visually displayed in the medical image;

the navigation component is used for responding to a trigger instruction, recording the reference position information of the sensor measured by the sensor when the sensor is at the reference position, acquiring the real-time position information of the sensor in a state that the sensor is fixed with an orthopedic operation tool, acquiring first relative position information and/or second relative position information based on the real-time position information, and prompting the first relative position information and/or the second relative position information; the first relative position information is relative position information between a real-time position of the sensor and the reference position, and the real-time position is determined by the real-time position information; the second relative position information is the relative position information between the real-time position and an ideal nail feeding point of the intramedullary nail, and is determined by the real-time position information and target offset position information;

When the sensor is positioned at the reference position, the sensor and the position mark of the developing and positioning assembly have a predetermined relative position relation; the position identifier is used for determining the target offset position information in combination with the predetermined relative position relationship, and the target offset position information is used for indicating the relative position relationship between the reference position and the ideal nail feeding point of the intramedullary nail;

the first relative position information in combination with the target offset position information and/or the second relative position information may be used to assist in guiding the orthopaedic surgical tool to move to the ideal intramedullary nail insertion point.

In a second aspect, the present application provides a medical navigation device for guiding an orthopaedic surgical tool, comprising a navigation assembly provided with a sensor and a visualization positioning assembly;

the navigation component is used for responding to a trigger instruction, recording the reference position information of the sensor measured by the sensor when the sensor is at the reference position, acquiring the real-time position information of the sensor in a state that the sensor is fixed with an orthopedic operation tool, acquiring first relative position information and/or second relative position information based on the real-time position information, and prompting the first relative position information and/or the second relative position information; the first relative position information is relative position information between a real-time position of the sensor and the reference position, and the real-time position is determined by the real-time position information; the second relative position information is relative position information between the real-time position and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by an expected insertion position and/or an expected insertion direction of the orthopedic operation tool in a human body;

When the sensor is positioned at the reference position, the sensor and the position mark of the developing and positioning assembly have a predetermined relative position relation; the position identifier is used for determining the target offset position information in combination with the pre-determined relative position relationship, and the target offset position information is used for indicating the relative position relationship between the reference position and the target position;

the first relative position information in combination with the target offset position information and/or the second relative position information may be used to assist in guiding the orthopaedic surgical tool to move to the target location.

In a third aspect, the present application provides a medical navigation device for guiding an orthopaedic surgical tool, comprising a navigation assembly provided with a sensor and a visualization and positioning assembly;

the navigation component is used for sending the real-time position information measured by the sensor to external processing equipment in a state that the sensor is fixed with the orthopedic operation tool, receiving first relative position information and/or second relative position information fed back by the external processing equipment and prompting the first relative position information and/or the second relative position information; the first relative position information is relative position information between a real-time position of the sensor and a reference position where the sensor is located in advance, the real-time position is determined by the real-time position information, the reference position is determined by pre-recorded reference position information, the reference position information comprises first reference position information and/or second reference position information, the first reference position information is position information which is obtained by the navigation component in response to a trigger instruction and is measured by the sensor and sent to the external processing device, and the second reference position information is preset position information obtained by the external processing device in response to the trigger instruction; the second relative position information is the relative position information between the real-time position of the sensor and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by the expected insertion position and/or the expected insertion direction of the orthopedic operation tool in the human body;

When the sensor is positioned at the reference position, the sensor and the position mark of the developing and positioning assembly have a predetermined relative position relation; the position identifier is used for determining the target offset position information in combination with the predetermined relative position relationship, and the target offset position information is used for indicating the relative position relationship between the reference position and the target position;

In a fourth aspect, the present application provides a medical navigation device for guiding an orthopaedic surgical tool, comprising a navigation assembly provided with a sensor and a visualization and positioning assembly;

the navigation component is used for responding to a trigger instruction, recording reference position information when the sensor is positioned at a reference position, acquiring real-time position information of the sensor in a state that the sensor is fixed with an orthopedic operation tool, acquiring first relative position information and/or second relative position information based on the real-time position information, transmitting the first relative position information and/or the second relative position information to external prompting equipment, and prompting the first relative position information and/or the second relative position information by the external prompting equipment; the first relative position information is the relative position information between the real-time position of the sensor and the reference position, and the real-time position is determined by the real-time position information; the second relative position information is relative position information between the real-time position and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by an expected insertion position and/or an expected insertion direction of the orthopedic operation tool in a human body;

wherein the first relative position information is combined with the target offset position information and/or the second relative position information is usable to assist in guiding the orthopaedic surgical tool to move to the target location.

In a fifth aspect, the present application provides a navigation processing device for guiding an orthopaedic surgical tool, the navigation processing device being in communication connection with a navigation assembly of a medical navigation device, the medical navigation device comprising the navigation assembly and a visualization positioning assembly, the navigation assembly being provided with a sensor;

the navigation processing device is used for acquiring real-time position information which is transmitted by the navigation component and measured by the sensor in a state that the sensor is fixed with the orthopedic operation tool, acquiring first relative position information and/or second relative position information based on the real-time position information, and prompting the first relative position information and/or the second relative position information; the first relative position information is relative position information between a real-time position of the sensor and a reference position where the sensor is located in advance, the real-time position is determined by the real-time position information, the reference position is determined by pre-recorded reference position information, the reference position information comprises first reference position information and/or second reference position information, the first reference position information is position information which is obtained by the navigation component in response to a trigger instruction and is measured by the sensor and sent to the navigation processing device, and the second reference position information is preset position information which is obtained by the navigation processing device in response to the trigger instruction; the second relative position information is relative position information between the real-time position and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by an expected insertion position and/or an expected insertion direction of the orthopedic operation tool in a human body;

In a sixth aspect, the present application provides a navigation method of a medical navigation device for intramedullary nail insertion point navigation, the medical navigation device comprising a navigation component and a visualization positioning component, the navigation component being provided with a sensor, the visualization positioning component being provided with a position marker, the position marker being capable of being visualized visually in a medical image, the method comprising:

when a trigger instruction is received, responding to the trigger instruction to record reference position information of a sensor of the navigation component when the sensor is at a reference position, wherein the sensor has a predetermined relative position relation with a position mark of the development positioning component when the sensor is at the reference position, the position mark is used for determining target offset position information in combination with the predetermined relative position relation, and the target offset position information is used for indicating the relative position relation between the reference position and an ideal intramedullary nail feeding point;

Acquiring real-time position information of the sensor in a state that the sensor is fixed with an orthopedic operation tool, and acquiring first relative position information and/or second relative position information based on the real-time position information, wherein the first relative position information is the relative position information between the real-time position of the sensor and the reference position, and the real-time position is determined by the real-time position information; the second relative position information is the relative position information between the real-time position and an ideal nail feeding point of the intramedullary nail, and is determined by the real-time position information and target offset position information;

prompting the first relative position information and/or the second relative position information, wherein the first relative position information is combined with the target offset position information, and/or the second relative position information can be used for assisting in guiding the orthopaedic surgical tool to move to the ideal intramedullary nail feeding point.

In a seventh aspect, the present application provides a navigation method for a medical navigation device for guiding an orthopaedic surgical tool, the medical navigation device comprising a navigation component provided with a sensor and a visualization positioning component provided with a location identifier, the location identifier being visualisable in a medical image, the method comprising:

When a trigger instruction is received, responding to the trigger instruction to record reference position information of a sensor of the navigation component when the sensor is at a reference position, wherein the sensor has a predetermined relative position relation with a position mark of the development positioning component when the sensor is at the reference position, the position mark is used for determining target offset position information in combination with the predetermined relative position relation, and the target offset position information is used for indicating the relative position relation between the reference position and the target position;

acquiring real-time position information of the sensor in a state that the sensor is fixed with an orthopedic operation tool, and acquiring first relative position information and/or second relative position information based on the real-time position information, wherein the first relative position information is the relative position information between the real-time position of the sensor and the reference position, and the real-time position is determined by the real-time position information; the second relative position information is relative position information between the real-time position and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by an expected insertion position and/or an expected insertion direction of the orthopedic operation tool in a human body;

And prompting the first relative position information and/or the second relative position information in real time, wherein the first relative position information is combined with the target offset position information, and/or the second relative position information can be used for assisting in guiding the orthopedic operation tool to move to the target position.

In an eighth aspect, the present application provides a navigation method for a medical navigation device for guiding an orthopaedic surgical tool, the medical navigation device comprising a navigation component provided with a sensor and a visualization positioning component provided with a location identifier, the location identifier being visualisable in a medical image, the method comprising:

acquiring real-time position information measured by a sensor of the navigation assembly fixed with an orthopedic operation tool;

transmitting the real-time position information to an external processing device;

receiving first relative position information and/or second relative position information fed back by the external processing equipment, and prompting the first relative position information and/or the second relative position information; the first relative position information is relative position information between a real-time position of the sensor and a reference position where the sensor is located in advance, the real-time position is determined by the real-time position information, the reference position is determined by pre-recorded reference position information, the reference position information comprises first reference position information and/or second reference position information, the first reference position information is position information which is obtained by the navigation component in response to a trigger instruction and is measured by the sensor and sent to the external processing device, and the second reference position information is preset position information obtained by the external processing device in response to the trigger instruction; the second relative position information is the relative position information between the real-time position of the sensor and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by the expected insertion position and/or the expected insertion direction of the orthopedic operation tool in the human body;

When the sensor is positioned at the reference position, the sensor and a position mark of the developing and positioning assembly have a predetermined relative position relation, the position mark is used for determining target offset position information in combination with the predetermined relative position relation, and the target offset position information is used for indicating the relative position relation between the reference position and the target position;

In a ninth aspect, the present application provides a navigation method for a medical navigation device for guiding an orthopaedic surgical tool, the medical navigation device comprising a navigation component provided with a sensor and a visualization positioning component provided with a location identifier, the location identifier being visualisable in a medical image, the method comprising:

when a trigger instruction is received, recording reference position information of a sensor of the navigation component when the sensor is at a reference position in response to the trigger instruction;

transmitting the first relative position information and/or the second relative position information to an external prompting device, and prompting the first relative position information and/or the second relative position information by the external prompting device;

when the sensor is positioned at the reference position, the sensor and a position mark of the developing and positioning assembly have a predetermined relative position relation, the position mark is used for determining target offset position information in combination with the predetermined relative position relation, and the target offset position information is used for indicating the relative position relation between the reference position and the target position; the first relative position information in combination with the target offset position information and/or the second relative position information may be used to assist in guiding the orthopaedic surgical tool to move to the target location.

In a tenth aspect, the present application provides a navigation method for a medical navigation device for guiding an orthopaedic surgical tool, the medical navigation device comprising a navigation component provided with a sensor and a visualization positioning component provided with a position identification, the position identification being visualisable in a medical image, the navigation component of the medical navigation device being in communicative connection with a navigation processing device, the method being performed by the navigation processing device, the method comprising:

acquiring real-time position information which is transmitted by the navigation component and measured by the sensor in a state that the sensor is fixed with an orthopedic operation tool;

acquiring first relative position information and/or second relative position information based on the real-time position information, wherein the first relative position information is the relative position information between the real-time position of the sensor and a reference position where the sensor is located in advance, the real-time position is determined by the real-time position information, the reference position is determined by pre-recorded reference position information, the reference position information comprises first reference position information and/or second reference position information, the first reference position information is the position information measured by the sensor, which is acquired by the navigation component in response to a trigger instruction and sent to the navigation processing device, and the second reference position information is preset position information acquired by the navigation processing device in response to the trigger instruction; the second relative position information is relative position information between the real-time position and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by an expected insertion position and/or an expected insertion direction of the orthopedic operation tool in a human body;

Prompting the first relative position information and/or the second relative position information;

In an eleventh aspect, the present application provides an electronic device comprising a processor and a memory storing a computer program, wherein the computer program, when executed by the processor, causes the processor to carry out the steps of the method in any of the embodiments described above.

In a twelfth aspect, the present application provides a computer readable storage medium having stored thereon a computer program, wherein the computer program, when executed by the processor, causes the processor to implement the steps of the method in any of the embodiments described above.

In a thirteenth aspect, the present application provides a computer program product comprising a computer program, wherein the computer program when executed by a processor realizes the steps of the method in any of the embodiments described above.

In a fourteenth aspect, the present application provides a medical navigation system comprising: an orthopaedic surgical tool, and a device as in any of the embodiments described above.

Based on the embodiment of the application, the developing and positioning component based on the medical navigation device can be used for assisting in determining the target positions of the ideal nail feeding point of the intramedullary nail and the like, and the first relative position information and/or the second relative position information are/is prompted to assist in guiding the orthopaedic operation tool to move to the target positions of the ideal nail feeding point of the intramedullary nail and the like, so that the radiation amount in the operation process is not increased, the convenience and the convenience are realized, and the assistance in improving the efficiency of the orthopaedic operation is facilitated.

The foregoing description is only an overview of the present application, and is intended to provide a better understanding of the technical means of the present application, as it is embodied in accordance with the present application, and is intended to provide a better understanding of the above and other objects, features and advantages of the present application, as it is embodied in the following specific examples.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for the description of the embodiments will be briefly described below, and it is apparent that the drawings in the following description are only embodiments of the present application, and other drawings can be obtained according to the disclosed drawings without inventive effort for a person skilled in the art. Also, like reference numerals are used to designate like parts throughout the accompanying drawings. In the drawings:

FIG. 1 is a schematic diagram of a medical navigation device according to some embodiments of the present application;

FIG. 2 is a schematic diagram of a medical navigation device according to some embodiments of the present application in combination with an external processing device;

FIG. 3 is a schematic diagram of a medical navigation device according to some embodiments of the present application in combination with an external prompting device;

FIG. 4 is a schematic diagram of a medical navigation device combined with a navigation processing device according to some embodiments of the present application;

FIG. 5 is a schematic structural view (first view) of a medical navigation device according to some embodiments of the present application;

FIG. 6 is a schematic structural view (second view) of a medical navigation device according to some embodiments of the present application;

FIG. 7 is a schematic diagram of a navigation assembly and a development positioning assembly in a separated state according to some embodiments of the present application;

FIG. 8 is a schematic diagram of a navigation assembly according to some embodiments of the present application;

FIG. 9 is an example of a coordinate system of a sensor of a navigation assembly of some embodiments of the present application;

FIG. 10 is a schematic diagram of first and/or second relative position information displayed by a navigation assembly in some embodiments of the application;

FIG. 11 is a schematic diagram of determining a height difference in some embodiments of the application;

FIG. 12 is a schematic diagram of an external bias angle determination in some embodiments of the application;

FIG. 13 is a schematic illustration of determining pitch angle in some embodiments of the application;

FIG. 14 is a schematic view of the ideal feed position of the ideal feed point of the intramedullary nail at the proximal end of the femur;

FIG. 15 is a schematic view of the ideal feed direction of the ideal feed point of the intramedullary nail at the proximal femur;

FIG. 16 is a schematic illustration of placement of a medical navigation device on a proximal body surface of a femur on a patient side in some embodiments;

FIG. 17 is a schematic diagram of determining target offset location information in combination with location identification after placement of a medical navigation device on a proximal body surface of a patient side femur in some embodiments;

FIG. 18 is a diagram illustrating an example of an application of a medical navigation device to determine a reference position on a proximal body surface of a femur on a patient side in other embodiments;

FIG. 19 is a schematic diagram of determining target offset position information based on medical images in some embodiments;

FIG. 20 is a schematic diagram of determining target offset position information based on medical images in other embodiments;

FIG. 21 is a schematic illustration of a navigation assembly secured to a lead in some embodiments;

figure 22 is a schematic view of a navigation assembly secured to a drill in some embodiments;

FIG. 23 is a schematic illustration of an ideal feed position for determining an ideal feed point for an intramedullary nail in an application scenario of some embodiments;

FIG. 24 is a schematic illustration of an ideal feed direction for determining an ideal feed point for an intramedullary nail in an application scenario of some embodiments;

FIG. 25 is a flow chart of a medical navigation method of some embodiments;

FIG. 26 is a flow chart of a medical navigation method of some embodiments;

FIG. 27 is a flow chart of a medical navigation method of some embodiments;

FIG. 28 is a flow chart of a medical navigation method of some embodiments;

fig. 29 is a block diagram of an electronic device of some embodiments.

Detailed Description

Reference will now be made in detail to examples of such embodiments, examples of which are illustrated in the accompanying drawings. Numerous specific details are set forth in the following detailed description in order to provide a thorough understanding of the various described embodiments. However, it will be understood by those of ordinary skill in the art that the various described embodiments may be practiced without these specific details. In other instances, well-known methods, procedures, components, circuits, and networks have not been described in detail so as not to unnecessarily obscure embodiments.

The terminology used in the description of the various illustrated embodiments herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used in the description of the various described embodiments and in the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will also be understood that the term "and/or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, and/or components.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs; the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application; the terms "comprising" and "having" and any variations thereof in the description of the application and the claims and the description of the drawings above are intended to cover a non-exclusive inclusion.

In the description of embodiments of the present application, the technical terms "first," "second," and the like are used merely to distinguish between different objects and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated, a particular order or a primary or secondary relationship. In the description of the embodiments of the present application, the meaning of "plurality" is two or more unless explicitly defined otherwise.

Reference herein to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment may be included in at least one embodiment of the application. The appearances of such phrases in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Those of skill in the art will explicitly and implicitly appreciate that the embodiments described herein may be combined with other embodiments.

Referring to fig. 1, a medical navigation device 10 in some embodiments includes a visualization and positioning assembly 100 and a navigation assembly 200, wherein the navigation assembly 200 is provided with a sensor 201. The medical navigation device 10 can be applied to the orthopedic operation process to realize the guidance of the orthopedic operation tool.

Wherein in this embodiment:

the developing and positioning assembly 100 is provided with a position mark which can be visually displayed in the medical image;

the navigation component 200 is used for responding to a trigger instruction, recording reference position information when the sensor 201 is at a reference position, which is measured by the sensor 201, acquiring real-time position information of the sensor 201 in a state that the sensor 201 is fixed with an orthopedic operation tool, acquiring first relative position information and/or second relative position information based on the real-time position information, and prompting the first relative position information and/or the second relative position information; wherein the first relative position information is the relative position information between the real-time position of the sensor 201 and the reference position, and the real-time position is determined by the real-time position information; the second relative position information is the relative position information between the real-time position and the target position, the second relative position information is determined by the real-time position information and the target offset position information, and the target position is determined by the expected insertion position and/or the expected insertion direction of the orthopedic operation tool in the human body;

when the sensor 201 is at the reference position, the sensor 201 and the position mark of the developing and positioning assembly have a predetermined relative position relation; the position identifier is used for determining the target offset position information by combining a predetermined relative position relationship, and the target offset position information is used for indicating the relative position relationship between the reference position and the target position;

The first relative position information in combination with the target offset position information and/or the second relative position information may be used to assist in guiding the movement of the orthopaedic surgical tool to the target location.

Referring to fig. 2, medical navigation device 10 in some embodiments includes a visualization and positioning assembly 100 and a navigation assembly 200, wherein navigation assembly 200 is provided with a sensor 201. The medical navigation device 10 can be applied to the orthopedic operation process to realize the guidance of the orthopedic operation tool. When the medical navigation device 10 is applied to the orthopedic operation process, the medical navigation device can be matched with the external processing equipment 20 to guide the orthopedic operation tool.

In this embodiment:

the navigation component 200 is configured to send real-time position information measured by the sensor 201 to the external processing device 20 in a state where the sensor 201 is fixed to the bone surgery tool, and receive the first relative position information and/or the second relative position information fed back by the external processing device 20, and prompt the first relative position information and/or the second relative position information; wherein the first relative position information is the relative position information between the real-time position of the sensor 201 and the reference position where the sensor 201 is located in advance, the real-time position is determined by the real-time position information, the reference position is determined by the pre-recorded reference position information, the reference position information comprises first reference position information and/or second reference position information, the first reference position information is the position information which is obtained by the navigation component 200 in response to the trigger instruction and is measured by the sensor 201 and sent to the external processing device 20, and the second reference position information is the preset position information which is obtained by the external processing device in response to the trigger instruction; the second relative position information is the relative position information between the real-time position of the sensor 201 and the target position, the second relative position information is determined by the real-time position information and the target offset position information, and the target position is determined by the expected insertion position and/or the expected insertion direction of the orthopaedic surgical tool in the human body;

Wherein, when the sensor 201 is at the reference position, the sensor 201 and the position mark of the developing and positioning assembly 100 have a predetermined relative position relationship; the position identifier is used for determining the target offset position information in combination with a predetermined relative position relationship, and the target offset position information is used for indicating the relative position relationship between the reference position and the target position;

Referring to fig. 3, medical navigation device 10 in some embodiments includes visualization positioning assembly 100 and navigation assembly 200, wherein navigation assembly 200 is provided with sensor 201. The medical navigation device 10 can be applied to the orthopedic operation process to realize the guidance of the orthopedic operation tool. When the medical navigation device 10 is applied to the orthopedic operation process, the medical navigation device can be matched with the external prompting equipment 30 to guide the orthopedic operation tool.

In this embodiment:

the navigation component 200 is configured to respond to a trigger instruction, record reference position information measured by the sensor 201 when the sensor 201 is at a reference position, obtain real-time position information of the sensor 201 in a state where the sensor 201 is fixed with the orthopaedic surgical tool, obtain first relative position information and/or second relative position information based on the real-time position information, transmit the first relative position information and/or the second relative position information to the external prompting device 30, and prompt the first relative position information and/or the second relative position information by the external prompting device 30; wherein the first relative position information is the relative position information between the real-time position of the sensor 201 and the reference position, and the real-time position is determined by the real-time position information; the second relative position information is the relative position information between the real-time position and the target position, the second relative position information is determined by the real-time position information and the target offset position information, and the target position is determined by the expected insertion position and/or the expected insertion direction of the orthopedic operation tool in the human body;

When the sensor 201 is at the reference position, the sensor 201 and the position mark of the developing and positioning assembly have a predetermined relative position relation; the position identifier is used for determining target offset position information in combination with a predetermined relative position relationship, and the target offset position information is used for indicating the relative position relationship between the reference position and the target position;

wherein the first relative position information in combination with the target offset position information and/or the second relative position information may be used to assist in guiding the orthopaedic surgical tool to move to the target location.

The external prompting device 30 may be any device capable of prompting information. For example, in some embodiments, the external prompting device 30 may be a smart wearable device. In some embodiments, the external alert device may be a user terminal (e.g., personal computer, tablet computer), in some embodiments, the external alert device may be a display screen device, in some embodiments, the external alert device may also be a voice output device.

Referring to fig. 4, medical navigation device 10 in some embodiments includes visualization positioning assembly 100 and navigation assembly 200, wherein navigation assembly 200 is provided with sensor 201. The medical navigation device 10 can be applied to the orthopedic operation process to realize the guidance of the orthopedic operation tool. When the medical navigation device 10 is applied to the orthopedic operation process, the guiding of the orthopedic operation tool can be realized by matching with the navigation processing device 40. The navigation processing device 40 is communicatively coupled to the navigation component 200 of the medical navigation device 10.

Wherein in this embodiment:

the navigation processing device 40 is configured to obtain real-time position information sent by the navigation component 200 and measured by the sensor 201 in a state where the sensor 201 is fixed to the orthopedic operation tool, obtain first relative position information and/or second relative position information based on the real-time position information, and prompt the first relative position information and/or the second relative position information; the first relative position information is the relative position information between the real-time position of the sensor 201 and the reference position where the sensor 201 is located in advance, the real-time position is determined by the real-time position information, the reference position is determined by the pre-recorded reference position information, the reference position information comprises first reference position information and/or second reference position information, the first reference position information is the position information which is obtained by the navigation component 200 in response to the trigger instruction and is measured by the sensor 201 and is sent to the navigation processing device 40, and the second reference position information is the preset position information which is obtained by the navigation processing device 40 in response to the trigger instruction; the second relative position information is the relative position information between the real-time position and the target position, the second relative position information is determined by the real-time position information and the target offset position information, and the target position is determined by the expected insertion position and/or the expected insertion direction of the orthopedic operation tool in the human body;

Wherein, when the sensor 201 is at the reference position, the sensor 201 and the position mark of the developing and positioning assembly 100 have a predetermined relative position relationship; the position identifier is used for determining target offset position information in combination with a predetermined relative position relationship, and the target offset position information is used for indicating the relative position relationship between the reference position and the target position;

In the medical navigation device 10 of the above embodiments, the sensor 201 may be an inertial sensor, which is a sensor capable of detecting and measuring acceleration, inclination, impact, vibration, rotation, and movement with multiple degrees of freedom, and the inertial sensor may measure and output position information. The number of the sensors 201 is specifically 1, so that medical navigation can be realized based on the same sensor.

In the medical navigation device 10 according to the above embodiments, the "medical image" includes, but is not limited to, an X-ray fluoroscopic image, a magnetic resonance imaging, and the like. The above-described "medical image" may be imaged under X-rays, high frequency RF propagation and external magnetic fields, ultrasound or gamma rays, or may be imaged in other ways, without limitation.

In some embodiments, the medical navigation device 10 of the embodiments described above may be applied to an orthopedic operation requiring insertion of an intramedullary nail, for example, an orthopedic operation of a proximal femur fracture, where the medical navigation device 10 may be a medical navigation device for navigating an intramedullary nail insertion point, the target position may be an ideal intramedullary nail insertion point, the desired insertion position may be an ideal nail insertion position of the ideal intramedullary nail insertion point, and the desired insertion direction may be an ideal nail insertion direction of the ideal intramedullary nail insertion point.

In the medical navigation device 10 of the above embodiments, the navigation module 200 and the developing and positioning module 100 may be fixedly connected or detachably connected, for example, the navigation module 200 and the developing and positioning module 100 may be assembled and connected by magnetic attraction, and for example, the navigation module 200 and the developing and positioning module 100 may be connected by a manner such as clamping or bonding, so as to facilitate the installation and the removal of the navigation module 200 and the developing and positioning module 100. Of course, the navigation module 200 may be detachably connected to the developing and positioning module 100 by other means besides clamping, bonding, and magnetic attraction, which is not particularly limited herein. Wherein, when the navigation assembly 200 and the developing and positioning assembly 100 are fixedly connected, or when the navigation assembly 20 and the developing and positioning assembly 100 are detachably connected together, the navigation assembly 200 and the developing and positioning assembly 100 have a predetermined relative positional relationship.

In other embodiments, the navigation assembly 200 and the visualization and positioning assembly 100 need not have a specific fixed or removable connection, so long as the navigation assembly 200 and the visualization and positioning assembly 100 can have a predetermined relative positional relationship when the medical navigation device 10 is in the reference position.

In some embodiments, schematic diagrams of predetermined relative positional relationships between the visualization and positioning assembly 100 and the navigation assembly 200 when the medical navigation device 10 is in the reference position are shown in fig. 5, 6, and 7.

In the embodiment shown in fig. 5, 6 and 7, the developing positioning assembly 100 includes a body 110. Wherein, at least one position mark 120 is disposed on the body 110, and the position mark 120 can be visually displayed in the medical image. The body 110 is further provided with a mounting portion 111 for mounting the navigation module 200, and at least one position mark 120 is distributed around the mounting portion 111.

Wherein the mounting portion 111 is configured to detachably connect to the navigation module 200. When in use, the body 110 can be detachably connected with the navigation assembly 200 through the mounting part 111, and the body 110 is placed above the to-be-operated position of the to-be-operated target, so that the position mark 120 and the to-be-operated position can be visually displayed in the medical image when the to-be-operated position is subjected to perspective obtaining of the medical image.

In some embodiments, optionally referring to fig. 5, 6 and 7, the location identifier 120 includes an angular scale, at least one angular scale being distributed around the mounting portion 111. Before operation, the developing and positioning assembly 100 may be disposed on the target to be operated, and the medical image (such as an X-ray perspective image) may be used to view information such as a specific position and an angle of the target to be operated, and the angle scale may be used as a reference to more easily assist in determining an expected insertion direction of the target position, for example, an ideal nail feeding direction of an ideal nail feeding point of an intramedullary nail, so as to assist in guiding the orthopaedic surgical tool to move to the target position such as the ideal nail feeding point of the intramedullary nail.

In some embodiments, referring to fig. 5, 6 and 7, optionally, the body 110 is provided with a plurality of angle scales, wherein the plurality of angle scales includes a reference angle scale (for example, a scale corresponding to 0 bit in fig. 7), and a non-reference angle scale disposed on at least one side of the reference angle scale, and the non-reference angle scale includes a positive angle scale and/or a negative angle scale.

Therefore, the positive angle scale or the negative angle scale can be conveniently read according to the needs, the reference angle scale can be used as a reference, and the positive angle scale or the negative angle scale corresponding to the expected insertion direction of the target position, such as the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail, in the multiple angle scales can be found out, so that the corresponding angle scale can be more conveniently read, and the expected insertion direction of the target position, such as the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail, can be more conveniently assisted.

In some embodiments, the reference angle scale of the developing position assembly 100 is located in the axial direction of the navigation assembly 200 when the navigation assembly 200 is in the reference position. That is, when the navigation module 200 is at the reference position, the position marks of the navigation module 200 and the developing and positioning module 100 have a predetermined relative positional relationship, which may mean that the reference angle scale of the developing and positioning module 100 is located in the axial direction of the navigation module 200 when the navigation module 200 is at the reference position. Therefore, the corresponding angle scale can be read more conveniently, and meanwhile, whether the position marks of the navigation assembly 200 and the developing and positioning assembly 100 meet the preset relative position relation can be verified and determined conveniently.

In some embodiments, the non-reference angle scale includes positive angle scales (e.g., angle scales corresponding to angle values of 10, 20, 30, 40 in fig. 7) and negative angle scales (e.g., angle scales corresponding to angle values of-10, -20, -30, 40 in fig. 7) symmetrically arranged on both sides of the reference angle scale with the reference angle scale as a reference. In this way, by means of a symmetrical distribution, it is possible to more easily assist in determining the intended insertion direction of the target location, e.g. the ideal screw-in direction of the ideal screw-in point of the intramedullary nail. It should be appreciated that in the illustration of fig. 7, positive and/or negative angle scales may also be included, as well as angle scales that do not display angle values. Of course, the distribution of the plurality of angle scales may be arranged in other manners that facilitate reading the angle scales, which is not particularly limited herein.

In some embodiments, referring to fig. 5, 6 and 7, the mounting portion 111 and the plurality of angle scales are disposed on the first surface 1101 of the body 110, so that the navigation module 200 disposed on the mounting portion 111 can conveniently navigate with reference to the angle scales. For example, the direction of the reference angle scale is taken as the reference direction, and the reference angle scale is taken as the reference direction to assist in determining the expected insertion direction of the target position, such as the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail, so that the bone surgery tool can be more conveniently guided to the expected insertion direction of the target position, such as the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail, under the navigation of the navigation assembly 200.

In some embodiments, referring to fig. 5, 6 and 7, the mounting portion 111 includes a mounting slot in which the navigation assembly 200 is at least partially received.

The navigation assembly 200 may be placed in the mounting groove, so that the navigation assembly 200 can be used with the developing and positioning assembly 100 conveniently, and it can be appreciated that a plurality of angle scales surround the mounting groove, so that the navigation assembly 200 can better assist in determining the expected insertion direction of the target position, such as the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail, by taking the direction of the reference angle scale as the reference direction.

In some embodiments, referring to fig. 5, 6 and 7, the mounting slot includes a bottom wall parallel to the first surface 1101 and a side wall connected to the bottom wall, and the navigation assembly 200 is removably connected to the bottom wall of the mounting slot. As such, the navigation assembly 200 may be mounted within the mounting slot such that the navigation assembly 200 is used with the developer positioning assembly 100. Alternatively, the projection of the side wall in a plane parallel to the first surface 1101 is configured as a closed curve.

In some embodiments, the navigation assembly 200 is clamped in the mounting groove, so that the navigation assembly 200 and the developing and positioning assembly 100 can be clamped and connected, the structure is relatively simple, and the installation and the disassembly of the navigation assembly 200 and the developing and positioning assembly 100 are more convenient. At this time, the plurality of angle scales are arranged around the mounting groove, so that when the navigation assembly 200 is mounted in the mounting groove, the navigation assembly 200 is also convenient to correspond to one of the plurality of angle scales, and the use is more convenient by taking the corresponding one as a reference.

In some embodiments, referring to fig. 5, 6 and 7, the projection of the mounting groove in a plane parallel to the first surface 1101 forms an axisymmetric pattern. The symmetry axis of the axisymmetric pattern is arranged co-linearly with the extension line of the projection of the reference angle scale in a plane parallel to the first surface 1101.

It will be appreciated that the navigation module 200 mounted in the mounting groove may be centered with respect to the reference angle scale, so that the navigation module 200 can more conveniently use the direction of the reference angle scale as the reference direction, and also can use the reference angle scale of the developing and positioning module 100 as the reference direction to assist in determining the desired insertion direction of the target position, such as the desired screw feeding direction of the desired screw feeding point of the intramedullary nail, so that the subsequent orthopaedic surgical tool can be adjusted relative to the reference direction under the navigation of the navigation module 200 to guide the orthopaedic surgical tool to move to the desired insertion direction of the target position, such as the desired screw feeding direction of the desired screw feeding point of the intramedullary nail.

In some embodiments, referring to fig. 5, an arc-shaped edge 1102 connected to the first surface 1101 is disposed on the outer periphery of the body 110, and a plurality of angle scales are disposed at intervals along the extending direction of the arc-shaped edge 1102.

Thus, any angle scale can be conveniently read according to the requirement. Illustratively, the distribution of the plurality of angular scales is in a fan-shaped arrangement, similar to the distribution of the angular scales of a protractor.

In some embodiments, referring to fig. 5, 6 and 7, the arcuate edge 1102 is configured as an arc, such that a plurality of angular scales are distributed in a circumferential array around the center of the arcuate edge 1102.

In some embodiments, referring to fig. 5, the body 110 includes a second surface 1103 disposed opposite the first surface 1101, wherein the first surface 1101 and the second surface 1103 are configured to be planar and parallel to each other. In this manner, the body 110 can be placed over the site to be operated on of the target to be operated on by means of the second surface 1103. The second surface 1103 may be used to more smoothly position the imaging positioning assembly 100, for example, on the proximal surface of the femur on the affected side, to better ensure that the imaging positioning assembly 100 remains relatively horizontal, and the position identifier 120 and the medical image of the imaging positioning assembly 100 may be used to more accurately derive target offset position information between the reference position and the target position, for example, between the reference position and the intended insertion direction of the target position (e.g., the ideal approach direction of the ideal approach point of the intramedullary nail).

The second surface 1103 may be a continuous plane or may be composed of a plurality of planes independent of each other, and is not particularly limited herein.

In some embodiments, the material of the location identifier 120 comprises tantalum, and in particular, the location identifier 120 is made of tantalum wire, such that the location identifier 120 can be visualized in a medical image (e.g., a fluoroscopic image). Alternatively, the body 110 is made of a light-transmitting material, so that the body 110 made of the light-transmitting material is not developed under the irradiation of X-rays, and does not affect the line of sight, and the body 110 is made of a carbon fiber material, for example.

In some embodiments, a first contact is provided on the developer positioning assembly 100 and a second contact is provided on the navigation assembly 200, the navigation assembly 200 being activated when the first contact is in contact with the second contact. Thus, when the medical navigation device 10 is not needed, the navigation module 200 and the developing and positioning module 100 can be separately placed (as shown in fig. 7), and at this time, the navigation module 200 is not activated and is in a state of not being started up for operation. When the medical navigation device 10 is needed to be used for medical navigation, the navigation assembly 200 is assembled and connected with the developing and positioning assembly 100, so that the first contact is contacted with the second contact, the navigation assembly 200 is activated, and the navigation assembly 200 is in an open state. Therefore, the navigation module 200 can be started conveniently, and meanwhile, the resources consumed by the navigation module 200 can be reduced, and the service life of the navigation module 200 can be prolonged.

There may be two first contacts provided on the developing and positioning assembly 100, such as the first contact 130 in fig. 7, and two second contacts (not shown) provided on the navigation assembly 200. Thus, by providing two contacts on both the developing and positioning assemblies 100 and the navigation assembly 200, the navigation assembly 200 can be re-activated when both contacts are in corresponding contact. So that the developing and positioning assembly 100 and the navigation assembly 200 are in a relatively stable state when the navigation assembly 200 is activated, thereby being beneficial to improving the accuracy of the medical navigation process.

After the navigation module 200 is activated, or after the navigation module 200 is activated for a certain period of time, or after the navigation module 200 is activated and it is monitored that the first contact and the second contact are not contacted for a certain period of time, the navigation module 200 is automatically switched to an inactive state, that is, to a state of not starting up to work, so as to reduce the resources consumed by the navigation module 200. Wherein the certain duration may be set in connection with the procedure duration, or by other means, such as manual input by a user. In other embodiments, after the navigation component 200 is activated, the navigation component 200 may be switched to the inactive state upon receiving an instruction to turn off the navigation component 200, whether or not the subsequent first contact is in contact with the second contact.

In some embodiments, the trigger instruction may include an activation signal generated when the first contact contacts the second contact. That is, when the first contact contacts the second contact and the activation signal generated by the contact of the first contact and the second contact is received, the trigger instruction is considered to be received, and the recording of the reference position information of the reference position can be automatically triggered.

In some embodiments, the reference position of the navigation component 200 may also be recorded when a trigger instruction is received after the navigation component 200 is activated. That is, when the first contact contacts the second contact and receives the activation signal generated by the contact of the first contact and the second contact, the recording of the reference position information of the reference position cannot be triggered yet, but when the first contact contacts the second contact and activates the navigation module 200, the reference position information of the reference position of the navigation module 200 is recorded again when the trigger command is further received. Thereby, the accuracy of the reference position information of the reference position recorded in some scenes can be improved accordingly, for example, after the first contact point is brought into contact with the second contact point, the medical navigation device 10 is placed in the scene of the surgical site of the patient.

In some embodiments, the navigation assembly 200 and the developing and positioning assembly 100 may be magnetically connected by the first contact and the second contact, so that the connection reliability of the navigation assembly 200 and the developing and positioning assembly 100 may be improved. Wherein the first contact may be disposed in the mounting slot such that the navigation assembly 200 may be securely positioned in the mounting slot.

Wherein the navigation assembly 200 can be removably secured to an orthopedic surgical tool. For example, the navigation assembly 200 may be removably secured to the orthopaedic surgical tool by magnetic attraction and/or snap-fit. The orthopedic surgical tool may be a guide pin, a holder, or an electric drill.

In some embodiments, in the medical navigation device 10 related to the above embodiments, the navigation component 200 may be provided with a touch screen, so that the navigation component 200 may receive a trigger instruction through the touch screen, and the trigger instruction may be used to indicate the reference position information in which the above reference position is recorded.

The trigger instruction can be sent out by operating a corresponding button or control displayed on the touch screen, clicking or double-clicking in a designated area or any position of the touch screen, or sliding a designated track on the touch screen, or by other touch modes. The navigation component 200 determines that a trigger instruction is received if an operation action for operating a corresponding button or control is received through the touch screen, or a specified touch action, such as a single click, a double click, or a specified sliding track, is identified.

In some embodiments, in the medical navigation device 10 related to the above embodiments, the navigation component 200 may further be provided with an entity key and/or a voice acquisition component, so as to receive a trigger instruction through the entity key and/or the voice acquisition component, where the trigger instruction may be used to indicate the reference position information in which the above reference position is recorded.

If the navigation module 200 is provided with a physical key, a trigger command may be issued by directly pressing the physical key. When the navigation module 200 receives the pressing operation through the entity key, it determines that the trigger instruction is received.

If the navigation assembly 200 is provided with a voice acquisition assembly, medical personnel (e.g., a doctor) can issue a "record reference location", "record location" or other voice message to issue the trigger instruction. The voice acquisition component acquires voice information and identifies the voice information. If it is recognized that the voice message includes "recording reference position", "recording position", or other predefined reference position information indicating the recording reference position, the navigation component 200 determines that the trigger command is received.

In the medical navigation device 10 according to the above embodiments, a touch screen, a physical button, a voice acquisition component, or the like, which can receive a trigger instruction may be provided on the external processing device 20 and/or the external presentation device 30 and/or the navigation processing device 40, so that the trigger instruction may be received by the external processing device 20 and/or the external presentation device 30 and/or the navigation processing device 40. The trigger instructions received by the external processing device 20 and/or the external presentation device 30 and/or the navigation processing means 40 may be forwarded to the navigation assembly 200.

The navigation module 200 and/or the external presentation device 30 and/or the navigation processing apparatus 40 may present the first relative position information and/or the second relative position information by displaying the first relative position information and/or the second relative position information in real time, or may output voice information of the first relative position information and/or the second relative position information, that is, voice information of the first relative position information and/or the second relative position information.

The manner of displaying the first relative position information and/or the second relative position information in real time is not limited, and for example, only the first relative position information and/or the second relative position information may be displayed, or the first relative position information and/or the second relative position information may be displayed simultaneously with the corresponding description information, which is used to explain the specific meaning of the displayed first relative position information and/or second relative position information. In some embodiments, information of the suggested movement direction given on the basis of the first relative position information and/or the second relative position information may also be displayed simultaneously, wherein different movement directions may be marked with different marks, e.g. different colors and/or different arrow directions, respectively.

The manner in which the first relative position information and/or the second relative position information are voice-prompted in real time is not limited, for example, only the first relative position information and/or the second relative position information are voice-prompted, and the first relative position information and/or the second relative position information can be simultaneously voice-prompted, and the description information corresponding to the first relative position information and/or the second relative position information is voice-prompted, which is used for describing the specific meaning of the first relative position information and/or the second relative position information of the voice prompt, and in some embodiments, the information of the suggested moving direction given based on the first relative position information and/or the second relative position information can be simultaneously voice-prompted.

In some embodiments, the reference position information is position information obtained by measuring in real time by the sensor 201 obtained in response to the trigger command when the trigger command is received. When the navigation module 200 receives the trigger instruction, the navigation module 200 can directly obtain the position information obtained by the real-time measurement of the sensor 201. When the external processing device 20 and/or the external presentation device 30 and/or the navigation processing apparatus 40 receive the trigger instruction, the external processing device 20 and/or the external presentation device 30 and/or the navigation processing apparatus 40 may forward the trigger instruction to the navigation component 200, or send an instruction instructing the navigation component 200 to provide position information to the navigation component 200 based on the trigger instruction, so as to instruct the navigation component 200 to obtain position information obtained by real-time measurement of the sensor 201, and feed back the position information to the external processing device 20 and/or the external presentation device 30 and/or the navigation processing apparatus 40, so that the external processing device 20 and/or the external presentation device 30 and/or the navigation processing apparatus 40 obtain the reference position information, and in this way, the obtained reference position information may be referred to as first reference position information in the embodiment of the present application.

In some embodiments, the reference position information is the position information obtained by the sensor 201 after initializing the sensor 201 in response to the trigger command when the trigger command is received, that is, the reference position information may be the initial position information of the sensor 201, which may be referred to as the second reference position information in the embodiment of the present application. The initial position information may be set based on actual technical needs, and in some embodiments, the initial position information may be zero position information. The zero position information may mean that the values of the information related to the position are all set to 0, for example, the height value is 0.

When the navigation component 200 receives the trigger instruction, the navigation component 200 can directly initialize the sensor 201 to obtain the position information obtained by measurement after the sensor 201 is initialized.

When the trigger instruction is received by the external processing device 20 and/or the external presentation device 30 and/or the navigation processing apparatus 40, in some embodiments, the external processing device 20 and/or the external presentation device 30 and/or the navigation processing apparatus 40 may use, as the reference position information, position information set in advance in the external processing device 20 and/or the external presentation device 30 and/or the navigation processing apparatus 40, where the preset position information is initial position information after the sensor 201 is initialized. The reference position information obtained in this way may be referred to as second reference position information in the embodiment of the present application. Meanwhile, when the external processing device 20 and/or the external prompting device 30 and/or the navigation processing apparatus 40 receive the trigger instruction, the trigger instruction may be forwarded to the navigation component 200 at the same time, or an initialization instruction may be sent to the navigation component 200 based on the trigger instruction to instruct the navigation component 200 to initialize the sensor 201.

In other embodiments, when the external processing device 20 and/or the external prompting device 30 and/or the navigation processing apparatus 40 receives the trigger instruction, the trigger instruction may be forwarded to the navigation component 200, or an instruction may be sent to the navigation component 200 based on the trigger instruction, and the navigation component 200 may be instructed to initialize the sensor 201 through the instruction, and provide the location information obtained by the sensor 201 after the sensor 201 is initialized. Upon receiving the instruction, the navigation module 200 initializes the sensor 201, obtains positional information obtained by measurement of the sensor 201, and feeds back the positional information to the external processing device 20 and/or the external presentation device 30 and/or the navigation processing device 40, thereby causing the external processing device 20 and/or the external presentation device 30 and/or the navigation processing device 40 to obtain the reference positional information.

In some embodiments, the first relative position information comprises a first displacement offset and/or a first angular offset between the real-time position and the reference position.

The first displacement bias may include: the distance between the real-time position of the sensor 201 and the reference position in a direction perpendicular to the horizontal plane. Wherein in some embodiments, the first displacement deviation may also be referred to as a height difference, as shown in fig. 11.

The first angular deviation may include: after the specified direction of the sensor 201 fixed with the orthopedic operation tool and the specified direction of the sensor 201 when in the reference position are projected to the same plane, the included angle between the two projections on the plane is formed. Wherein, in some embodiments, the first angle deviation may also be referred to as an external deviation angle.

In some embodiments, the designated direction of the sensor 201 may be specifically an axial direction of the navigation assembly 200, and the same plane may be specifically a horizontal plane, as shown in fig. 12. When the specified direction of the sensor 201 fixed to the orthopedic operation tool and the specified direction of the sensor 201 when the sensor 201 is at the reference position are projected, the projection may be performed in combination with the coordinate system established by the sensor 201 itself. In one example, the coordinate system established by the sensor 201 is shown in fig. 9, and in fig. 9, the X-axis of the coordinate system established by the sensor 201 is the axis direction of the navigation module 200, that is, the designated direction of the sensor 201.

In some embodiments, the second relative positional information includes a second positional deviation and/or a second angular deviation between the real-time position and a target position, wherein the target position is determined by an intended insertion position and/or an intended insertion direction of the orthopaedic surgical tool in the human body. In some embodiments, the target location may be a location of the desired insertion of the surgical tool such as an ideal intramedullary nail insertion point, and the target location is the ideal intramedullary nail insertion point, and the second relative positional information includes a second displacement offset and/or a second angular offset between the real-time location and the ideal intramedullary nail insertion point, where the desired insertion location is the ideal nail insertion location of the ideal intramedullary nail insertion point and the desired insertion direction is the ideal nail insertion direction of the ideal intramedullary nail insertion point.

The second angular deviation includes: the designated direction of the sensor 201 at the real-time position and the expected insertion direction of the target position, such as the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail, are projected to the same plane, and then the included angle between the two projections on the same plane is formed. In some embodiments, the specified direction of the sensor 201 may be specifically an axial direction of the navigation assembly 200, and the same plane may be specifically a horizontal plane.

Wherein the desired insertion direction, e.g. the desired screw-in direction of the desired screw-in point of the intramedullary screw, can be determined in various possible ways.

In some embodiments, the desired insertion direction, such as the desired approach direction of the desired approach point of the intramedullary nail, may be obtained by a medical professional viewing the medical image, for example, taking a picture of the medical image with the navigation assembly 200 in a reference position, with the visual indication of the position of the visualization positioning assembly 100 in the medical image. Medical staff can determine the expected insertion direction such as the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail by looking at the medical image.

In some embodiments, the desired insertion direction, e.g., the desired screw insertion direction of the desired screw insertion point of the intramedullary nail, is a user-provided insertion direction. For example, when the navigation assembly 200 is located at a reference position, a photographing is performed to obtain a medical image in which the position identification of the visualization positioning assembly 100 appears visually. Medical staff can determine the expected insertion direction such as the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail by looking at the medical image, and observe and determine the position mark parallel to the expected insertion direction such as the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail by combining with the displayed position mark, or measure and obtain the position mark parallel to the expected insertion direction such as the ideal nail feeding direction of the marked ideal nail feeding point of the intramedullary nail by measuring through a measuring tool such as a ruler, and then select the position mark by clicking or inputting information of the position mark, and determine the expected insertion direction provided for a user, such as the ideal nail feeding direction of the ideal nail feeding point provided for the user.

In some embodiments, the desired insertion direction, such as the desired screw insertion direction of the desired screw insertion point of the intramedullary nail, may also be obtained by analyzing a medical image taken while the navigation assembly 200 is in the reference position. For example, by image processing the medical image, the intended insertion direction, e.g. the ideal screw-in direction of the ideal screw-in point of the intramedullary nail, is identified. Taking the navigation of the intramedullary nail feeding point as an example, the method can also identify the axis direction of the femur shaft by performing image processing on the medical image, and determine the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail by combining the angle (for example, 5 degrees) between the axis direction of the femur shaft and the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail.

The target offset position information may be determined in combination with the position identifier and the predetermined relative positional relationship to indicate a relative positional relationship between the reference position and the target position (e.g., the ideal nail insertion point of the intramedullary nail). In some embodiments, the target offset position information may be an angle between a specified direction of the sensor 201 when in the reference position and an intended insertion direction (e.g., ideal feed direction) of the target position (e.g., ideal feed point of the intramedullary nail).

In some embodiments, the angle between the specified direction of the sensor 201 when in the reference position and the intended insertion direction (e.g., ideal approach direction) of the target location (e.g., ideal approach point of the intramedullary nail) may be determined in various possible ways.

Taking the specified direction of the sensor 201 as the axial direction of the navigation module 200 as an example, when the sensor 201 is at the reference position, the position identifier of the sensor 201 and the developing and positioning module 100 have a predetermined relative positional relationship, and when the sensor 201 is at the reference position, the reference angle scale of the developing and positioning module 100 may be located in the axial direction of the navigation module 200.

Taking a predetermined relative positional relationship, in which the sensor 201 is at the reference position, as an example, the reference angle scale of the developing and positioning assembly 100 is located in the axial direction of the navigation assembly 200, the following is exemplified by the manner of determining the included angle between the specified direction of the sensor 201 at the reference position and the intended insertion direction of the target position (e.g., the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail) in combination with several of them.

In some embodiments, if the medical staff determines the desired insertion direction (e.g., the desired insertion direction of the desired insertion point of the intramedullary nail) by viewing the medical image, the displayed position mark may be combined with the viewing to determine the position mark parallel to the desired insertion direction, and the angle between the position mark and the reference angle scale may be used as the angle between the designated direction of the sensor 201 at the reference position and the desired insertion direction of the target position (e.g., the desired insertion direction of the desired insertion point of the intramedullary nail). If the reference angle scale is 0 °, the angle scale corresponding to the determined position mark may be directly used as the included angle. After determining the included angle, the medical staff can record the included angle by himself so as to facilitate the subsequent use. In some embodiments, the healthcare worker may also input the determined included angle to the navigation assembly 200 and/or the external processing device 20 and/or the external prompting device 30 and/or the navigation processing device 40 by input or other means to facilitate subsequent use.

In some embodiments, if the medical personnel determines the desired insertion direction (e.g., the desired nail insertion direction of the desired nail insertion point of the intramedullary nail) by viewing the medical image, and in conjunction with the displayed position indication, the position indication parallel to the desired insertion direction is determined by viewing, or by measuring the position indication parallel to the determined desired insertion direction (e.g., the desired nail insertion direction of the desired nail insertion point of the intramedullary nail) by a measuring tool capable of determining line parallelism by a ruler or the like, and selecting the position indication by clicking or inputting information of the position indication, or the like, the navigation module 200 and/or the external processing device 20 and/or the external presentation device 30 and/or the navigation processing device 40 may directly use the angle between the position indication and the reference angle scale as the specified direction of the sensor 201 at the reference position, the angle between the desired insertion direction of the target position (e.g., the desired nail insertion direction of the desired nail insertion point of the intramedullary nail) in response to the operation. If the reference angle scale is 0 °, the angle scale corresponding to the determined position mark may be directly used as the included angle.

In some embodiments, if the desired insertion direction (e.g., the desired insertion direction of the desired insertion point of the intramedullary nail) is obtained by analyzing the medical image, the device for performing the image analysis may analyze and determine, from the displayed location identifiers, a location identifier that is parallel to the identified desired insertion direction (e.g., the desired insertion direction of the desired insertion point of the intramedullary nail), and determine the direction corresponding to the location identifier as the desired insertion direction (e.g., the desired insertion direction of the desired insertion point of the intramedullary nail). And the angle between the position mark and the reference angle scale is taken as the angle between the designated direction of the sensor 201 when in the reference position and the expected insertion direction of the target position (such as the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail). If the reference angle scale is 0 °, the angle scale corresponding to the determined position mark may be directly used as the included angle. If the device for performing image processing is different from the device for performing navigation module 200 and/or external processing device 20 and/or external presentation device 30 and/or navigation processing device 40, the device for performing image processing may transmit the included angle θ to navigation module 200 and/or external processing device 20 and/or external presentation device 30 and/or navigation processing device 40 by wired or wireless method, or may input the included angle θ to navigation module 200 and/or external processing device 20 and/or external presentation device 30 and/or navigation processing device 40 by the medical staff after the medical staff knows the included angle.

Wherein the second displacement offset may comprise: in a direction perpendicular to the horizontal plane, the sensor 201 is located at a distance between the real-time position and the intended insertion position (e.g. the ideal screw feeding position of the ideal screw feeding point of the intramedullary nail).

Wherein the intended insertion position may be determined based on a predetermined insertion area, which may refer to an area used to determine the intended insertion position. Taking the target location as the ideal approach point for the intramedullary nail at the proximal end of the femur as an example, the predetermined insertion region may be the greater trochanter apex ridge profile. Specific positional information of the intended insertion location may be determined during movement of the orthopaedic surgical tool secured to the sensor 201.

In some embodiments, the height value of the intended insertion location (e.g., the ideal screw insertion location of the ideal screw insertion point) in a direction perpendicular to the horizontal plane is determined by a first reference height value that is the height value of the sensor 201 in a direction perpendicular to the horizontal plane when the insertion end of the orthopaedic surgical tool is located at a first side vertex of the predetermined insertion area and a second reference height value that is the height value of the sensor 201 in a direction perpendicular to the horizontal plane when the insertion end of the orthopaedic surgical tool is located at a second side vertex of the predetermined insertion area. Taking the target position as an ideal nail feeding point of the intramedullary nail at the proximal end of the femur as an example, the first side vertex can be the vertex of the greater trochanter vertex ridge profile closest to the ventral side, and the second side vertex can be the vertex of the greater trochanter vertex ridge profile closest to the dorsal side.

In some embodiments, the sensor 201 may also be used to measure a pitch angle, wherein the pitch angle is the angle between the bottom surface of the navigation assembly 200 and the horizontal plane, as shown in fig. 13.

In some embodiments, the navigation assembly 200 is also used to prompt the pitch angle measured by the sensor 201. In some embodiments, the navigation assembly 200 may also transmit the pitch angle measured by the sensor 201 to the external prompting device 30 and/or the navigation processing means 40 for prompting.

In some embodiments, the navigation component 200 is further configured to provide error indication information.

In some embodiments, the error prompt information is information generated when the cumulative time length is greater than a preset time length. Wherein the accumulated time period is a time period from when the reference position information is recorded or when the sensor 201 is last calibrated. In the use process of the sensor 201, when the use time is too long, errors may be caused, so that the time counting accumulation duration can be started from the time of recording the reference position information or the time of calibrating the sensor 201 last time, and when the accumulation duration is longer than the preset duration, the sensor 201 is considered to have errors, and error prompt information can be provided.

In some embodiments, the error hint information is information generated when the calculated error is greater than an error threshold. During use of the sensor 201, the navigation component 200 can simultaneously monitor and calculate an error of the sensor 201, and generate an error prompt message when the calculated error is greater than an error threshold. The error threshold may be set according to the accuracy of the sensor 201, and the embodiment of the present application is not specifically limited.

The error prompt information provided by the navigation component 200 may be prompted by the navigation component 200, or the navigation component 200 may send the error prompt information to the external prompt device 30 and/or the navigation processing device 40, and the external prompt device 30 and/or the navigation processing device 40 may prompt the error prompt information.

When knowing the error prompt information, the medical staff determines that the error of the sensor 201 is larger, so that the sensor 201 can be initialized or recalibrated, and the reference position information can be redetermined, so that the accuracy of medical navigation is improved. In some embodiments, the medical staff can also directly select the navigation component 200 containing other sensors 201 to cooperate with the developing and positioning component 100 to perform medical navigation, so as to improve the accuracy of medical navigation.

Taking an intramedullary nail operation as an example, based on the above-described example, a procedure for medical navigation based on the medical navigation device 10 and/or the navigation processing device 40 is illustrated in the following in connection with a specific operation procedure. It should be understood that these embodiments are not intended to limit the applicable types of orthopedic operations provided by the medical navigation device 10 and/or the navigation processing device 40, and that the medical navigation device 10 and/or the navigation processing device 40 provided by the present application may be equally applicable to other orthopedic operations in which similar processes may be performed based on the manner in which the medical navigation device 10 and/or the navigation processing device 40 performs medical navigation.

Fractures of the proximal femur (such as intertrochanteric fractures) or fractures of the diaphysis of long bones such as tibial humerus are often treated by means of intramedullary nail internal fixation to facilitate fracture healing. The choice of the position and direction of the intramedullary nail is important in the implementation of the whole operation for intramedullary nail fixation. This is because, advance nail position and advance nail direction and can influence the establishment of later stage expanded marrow passageway and intramedullary nail owner nail and put into position and direction, select improperly and can lead to the owner nail to be difficult to get into the medullary cavity, even can knock into the medullary cavity by force, also can lead to the owner nail to stress unevenly and warp great in the medullary cavity, destroy the fracture reduction effect easily this moment, the far end locking condition of locking inaccuracy takes place more easily when the owner nail is long owner nail, still can lead to fracture department delay healing even healing or abnormal healing when serious.

Taking the nail feeding point of the proximal intramedullary nail of the femur as an example, in clinic, the ideal nail feeding position is positioned at the vertex of the greater trochanter and near the central axis of the femoral neck, as shown in fig. 14, and the ideal nail feeding direction is 5 degrees outwards of the axis of the femoral shaft, so as to adapt to the external deflection angle of the main nail, as shown in fig. 15.

In the operation process, the nail feeding position and the nail feeding direction of the nail feeding point are usually confirmed by driving a guide needle, the needle feeding position of the guide needle is the nail feeding position of the later-stage main nail, and the needle feeding direction of the guide needle is the nail feeding direction of the later-stage main nail. To better select the insertion point, the inventor found that the existing manner of driving the guide needle, in order to ensure that the driven guide needle is in a satisfactory insertion position and insertion direction, or that continuous radioscopy is required during the entire driving of the guide needle to observe the position and direction of the needle tip of the guide needle in real time, but this method would certainly increase the amount of radiation to which the patient and doctor are exposed. Or a doctor firstly drives a guide pin into the nail feeding point through touching the vertex of the greater rotor, then carries out perspective, confirms the nail feeding position and the nail feeding direction according to the perspective image, if the nail feeding position and the nail feeding direction are not ideal, the doctor estimates the position and the angle to be adjusted through the perspective image, drives a second guide pin under the condition of not pulling out the first guide pin, and then carries out perspective checking on the nail feeding position and the nail feeding direction of the second guide pin again, and repeatedly carries out the steps until the perspective checking is carried out, and the driven guide pin is confirmed to reach the satisfactory nail feeding position and the satisfactory nail feeding direction. However, the guide pin which is driven for the first time according to subjective experience is generally difficult to reach an ideal nail feeding point of an expected intramedullary nail, the operation time is greatly prolonged in the later adjustment process according to the perspective result, the adjustment amount of the position and the angle cannot be accurately controlled, and meanwhile, the perspective times and the radiation amount of a patient and a doctor are increased.

Accordingly, the embodiment of the application provides the medical navigation device 10 which is light, convenient and easy to realize without increasing the perspective times and the radiation quantity of a patient and a doctor. The medical navigation device 10 may be used to guide the movement of an orthopaedic surgical tool, for example, to guide the movement of an orthopaedic surgical tool to the desired point of insertion of an intramedullary nail. As shown in fig. 1 to 4, the medical navigation device 10 includes a navigation module 200 and a developing and positioning module 100, wherein the navigation module 200 and the developing and positioning module 100 are separately designed and can be detachably connected, and the navigation module 200 is provided with a sensor. In some embodiments, the medical navigation device 10 with the navigation module 200 and the developing and positioning module 100 connected is shown in fig. 5 and 6. A schematic diagram of the navigation assembly 200 and the development positioning assembly 100 when separated from each other in some embodiments is shown in fig. 7. An external schematic of the navigation assembly 200 in some embodiments is shown in fig. 8. In some embodiments, when the navigation module 200 and the developing and positioning module 100 are assembled in the state shown in fig. 5 and 6, the navigation module 200 is at the reference position, and when the reference position is zero position information, it may also be considered that the sensor of the navigation module 200 is in the zero state when the navigation module 200 and the developing and positioning module 100 are assembled in the state shown in fig. 5 and 6.

The sensor 201 is integrated in the navigation module 200, and the sensor 201 may be a six-degree-of-freedom inertial sensor, and the sensor 201 is used for measuring a position deviation (x, y, z) and an angle deviation (α, β, γ) of the navigation module 200 relative to a reference position. Definition of the own coordinate system of the sensor 201 as shown in fig. 9, after setting the reference position information of the sensor 201, the sensor 201 is moved, and the sensor 201 can measure the relative position information of the real-time position of the sensor 201 with respect to the reference position, that is, the displacement amounts (x, y, z) along 3 coordinate axes and the angular deviations (α, β, γ) of the current directions of the respective coordinate axes from the reference coordinate axis directions. Wherein, the sensor 201 is integrated inside the navigation module 200, so that the reference position information of the sensor 201 can be used as the reference position information of the navigation module 200, the real-time position information of the sensor 201 can be used as the real-time position information of the navigation module 200, the reference position information determines the reference position of the sensor 201 and/or the navigation module 200, and the real-time position information determines the real-time position of the sensor 201 and/or the navigation module 200. Wherein in some embodiments the sensor 201 may also measure the pitch angle of the bottom surface of the navigation assembly 200 with respect to the absolute horizontal plane. In other embodiments, the navigation assembly 200 can also be integrated with a level meter by which the pitch angle of the bottom surface of the navigation assembly 200 relative to the absolute horizontal is measured.

In the navigation module 200 shown in fig. 8 and 10, the navigation module 200 is provided with a digital display screen (hereinafter referred to as a screen) on which 3 numerals are displayed, the symbol "Δ" indicates a displacement deviation symbol for indicating that a value adjacent thereto is a displacement deviation (for example, a first displacement deviation or a second displacement deviation as described above), and the symbol "°" indicates that a value corresponding thereto is an angle for indicating that a value adjacent thereto is an angle deviation (for example, a first angle deviation or a second angle deviation as described above) or a pitch angle.

For example, in the illustration of fig. 10, "Δ3" indicates that the first displacement deviation of the real-time position of sensor 201 and/or navigation assembly 200 from the reference position is 3, or that the second displacement deviation of the real-time position of sensor 201 and/or navigation assembly 200 from the intended insertion position (e.g., the ideal nail feeding position of the ideal nail feeding point of the intramedullary nail) is 3. "18" means that the first angular deviation of the real-time position of the sensor 201 and/or the navigation assembly 200 from the reference position is 18 °, or that the second angular deviation of the real-time position of the sensor 201 and/or the navigation assembly 200 from the intended insertion direction (e.g. the ideal screw-in direction of the ideal screw-in point of the intramedullary nail) is 18 °, and "4" means that the pitch angle is 4 °.

The first displacement deviation, the second displacement deviation, the first angle deviation, and the second angle deviation may be determined in combination with the coordinate system of the sensor 201 when the sensor 201 and/or the navigation module 200 are located at the reference position and the real-time position. Note that the coordinate system of the sensor 201 at the reference position is ψ (hereinafter referred to as a reference coordinate system), and the coordinate system of the sensor 201 at the real-time position is ψ '(hereinafter referred to as a current coordinate system), the first displacement deviation, the second displacement deviation, the first angle deviation, and the second angle deviation can be obtained by calculating the positional offset and the angular offset of the current coordinate system ψ' with respect to the reference coordinate system ψ.

For example, taking the first displacement deviation as an example, the projection of the displacement of the origin of the current coordinate system ψ' relative to the origin of the reference coordinate system ψ on the Z axis of the reference coordinate system ψ is taken as a height difference Δh, which is the above-mentioned first displacement deviation as shown in fig. 11; the angle between the projection of the X axis of the current coordinate system ψ', i.e. the coordinate axis in which the axis direction of the navigation module 200 is located, on the XOY plane of the reference coordinate system ψ and the X axis of the reference coordinate system is taken as the external offset angle, which is the first angle deviation as shown in fig. 12. As another example, a pitch angle of the plane of the bottom surface of the navigation module 200 with respect to the absolute horizontal plane is taken as a pitch angle, wherein the deviation is positive when the tail (narrow end) is tilted and negative when the head (wide end) is tilted, as shown in fig. 13.

Since the intramedullary nails at different positions, such as femur, tibia, humerus intramedullary nail and other positions, have similar nail feeding points, the proximal femur intramedullary nail operation will be described in detail below as an example.

The patient's usual position in the proximal femur intramedullary nail operation is in the supine position, and the medical navigation device 10 needs to be placed at a reference position, for example, on the proximal femur surface of the patient's affected side, in a manner of a predetermined relative positional relationship between the sensor 201 and/or the navigation assembly 200 and the positional identifier of the visualization positioning assembly 100, before the guide pin is driven after the skin incision.

In some embodiments, the developing and positioning assembly 100 and the navigation assembly 200 may be assembled and connected, where the assembled and connected navigation assembly 200 and the position identifier of the developing and positioning assembly 100 have a predetermined relative positional relationship, and as an example of the medical navigation device 10 described above, the reference angle scale of the developing and positioning assembly 100 is located in the axial direction of the navigation assembly 200, and then the assembled and connected medical navigation device 10 is placed at a reference position, for example, on the proximal femur surface of the patient, as shown in fig. 16 and 18, where the navigation assembly 200 is kept relatively horizontal and the developing and positioning assembly 100 is kept relatively horizontal. It should be appreciated that, since the developing and positioning assembly 100 is assembled and connected with the navigation assembly 200 and then placed at the reference position, the predetermined relative positional relationship between the position identifiers of the navigation assembly 200 and the developing and positioning assembly 100 remains unchanged after the assembly and connection.

In some embodiments, the developing and positioning assembly 100 may be placed at a position corresponding to a reference position, for example, on a proximal surface of a femur on a patient's affected side, then the position of the developing and positioning assembly 100 is maintained, and then the navigation assembly 200 is assembled with the developing and positioning assembly 100 in a manner having a predetermined relative positional relationship between the position identifiers of the navigation assembly 200 and the developing and positioning assembly 100, or the navigation assembly 200 is placed at a position capable of corresponding to the predetermined relative positional relationship, so long as the position of the navigation assembly 200 is reached, the position identifiers of the navigation assembly 200 and the developing and positioning assembly 100 can have a predetermined relative positional relationship.

In some embodiments, the navigation component 200 may be placed at a position corresponding to the reference position, for example, on the proximal femur surface of the patient's affected femur, then the position of the navigation component 200 is maintained unchanged, and then the developing and positioning component 100 is assembled with the navigation component 200 in a manner of having a predetermined relative positional relationship between the position identifiers of the navigation component 200 and the developing and positioning component 100, or the developing and positioning component 100 is placed at a position capable of corresponding to the predetermined relative positional relationship, so long as the position identifiers of the navigation component 200 and the developing and positioning component 100 can have a predetermined relative positional relationship when the developing and positioning component 100 is placed at the position.

Wherein, the developing and positioning assembly 100 is provided with a first contact, the first contact can be arranged in the mounting groove of the developing and positioning assembly 100, the navigation assembly 200 is provided with a second contact, the second contact is arranged at a position on the navigation assembly 200 corresponding to the first contact of the developing and positioning assembly 100, and when the first contact is contacted with the second contact, the navigation assembly 200 is activated.

After the medical navigation device 10 is placed at a reference position in a manner having a predetermined relative positional relationship between the sensor 201 and/or the navigation assembly 200 and the positional identification of the visualization positioning assembly 100, reference position information of the reference position may be recorded.

In some embodiments, if the navigation module 200/the developing and positioning module 100 is placed first, and then the developing and positioning module 100/the navigation module 200 is placed again, so that the navigation module 200 and the position identifier of the developing and positioning module 100 have a predetermined relative position relationship, when the navigation module 200 is activated, the navigation module 200 is determined to be at a reference position, and the position information obtained by measuring the sensor 201 at this time is recorded as the reference position information, where the reference position information may be initial position information of the sensor 201, for example, zero position information.

In some embodiments, the reference position information may be recorded by responding to a trigger instruction by way of the user issuing the trigger instruction. For example, a medical person (e.g., a physician) enters a trigger instruction through the navigation assembly 200 and/or the external processing device 20 and/or the external prompting device 30 and/or the navigation processing means 40.

In the medical navigation device 10 of the embodiment shown in fig. 1 and 3, a medical staff (such as a doctor) may operate the navigation module 200 to issue a trigger command, and the navigation module 200 receives the trigger command and records the position information measured by the sensor 201 when receiving the trigger command as the reference position information. After receiving the trigger instruction, the navigation module 200 may initialize the sensor 201 first, and record the initialized position information measured by the sensor 201 (i.e., the initial position information of the sensor 201) as the reference position information.

In the medical navigation device 10 of the embodiment shown in fig. 2 and 4, a medical person (e.g., a doctor) may issue a trigger instruction by operating the navigation module 200, or may issue a trigger instruction by operating the external processing apparatus 20/the navigation processing device 40. If the navigation module 200 is operated to issue the trigger command, the navigation module 200 records the reference position information in the same manner as described above. After recording the reference position information, the navigation module 200 may transmit the reference position information to the external processing device 20/the navigation processing means 40. If the external processing device 20/the navigation processing device 40 is operated to issue a trigger instruction, in some embodiments, the external processing device 20/the navigation processing device 40 sends the trigger instruction to the navigation component 200, so as to instruct the navigation component 200 to obtain and return the position information measured by the sensor 201 at the time, and record the position information as reference position information; in other embodiments, if the reference position information is preset position information (e.g. the zero position information of the sensor 201 after initializing the sensor 201), the external processing device 20/the navigation processing device 40 may directly use the preset position information as the reference position information, and may send an instruction to the navigation module 200, where the instruction instructs the navigation module 200 to initialize the sensor 201.

The reference position information recorded may include a reference height of the sensor 201 with respect to a horizontal plane, and a specified direction of the sensor 201 (such as an axial direction of the navigation module 200). Taking the reference position information as zero position information as an example, the height output from the sensor 201 is 0. If the first relative position information is prompted by the navigation module 200 in real time, the height difference Δh on the screen of the navigation module 200 is displayed as 0, the external deflection angle is displayed as 0 °, and the pitch angle is close to 0 °.

In the case where the medical navigation device 10 is placed at the reference position in such a manner that there is a predetermined relative positional relationship between the positional identifications of the navigation assembly 200 and the visualization positioning assembly 100, the medical staff takes an image of the positive piece of the proximal femur using a C-arm device or other transmission device, and obtains a medical image in which the site to be operated, such as the proximal femur, and the positional identification of the visualization positioning assembly 100 can be visualized in the medical image.

After the medical image is obtained, a position mark parallel to the expected insertion direction (e.g., the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail) and an angle value X corresponding to the position mark may be selected from the position marks of the developing and positioning assembly 100 displayed in the medical image based on the medical image, wherein the angle value X is also an included angle θ between the axis direction of the navigation assembly 200 and the expected insertion direction (e.g., the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail), and the included angle θ is the target offset position information between the target position (e.g., the ideal nail feeding point of the intramedullary nail) and the reference position of the sensor 201.

In some embodiments, the determination of the expected insertion direction (such as the ideal nail insertion direction of the ideal nail insertion point of the intramedullary nail) and the included angle θ may be obtained by observing a medical image by a medical staff, for example, by observing the medical image, the medical staff (such as a doctor) may determine the expected insertion direction (such as the ideal nail insertion direction of the ideal nail insertion point of the intramedullary nail) and, in combination with the displayed position identifier, observe and determine a position identifier parallel to the expected insertion direction (such as the ideal nail insertion direction of the ideal nail insertion point of the intramedullary nail), and determine the angle corresponding to the position identifier as the included angle θ. As shown in fig. 17, if it is observed that the position mark parallel to the intended insertion direction (such as the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail) is determined as the position mark 140 corresponding to the angle mark 10, the value of the included angle θ may be determined as the angle mark 10 ° corresponding to the position mark 140.

Because the doctor clearly knows the position where the bone surgery is expected to be performed when the bone surgery is performed, for example, the ideal nail feeding position of the ideal nail feeding point of the intramedullary nail is located at the vertex of the greater trochanter and is close to the central axis of the femoral neck, as shown in fig. 14, and the ideal nail feeding direction is the outer deviation angle of the axis of the femoral shaft by 5 degrees so as to adapt to the outer deviation angle of the main nail, the doctor can quickly determine the ideal nail feeding direction in the medical image by looking at the medical image, and then can find a position mark parallel to the ideal nail feeding direction, and the angle value X corresponding to the position mark is the angle theta between the axis direction of the navigation assembly 200 when the navigation assembly is located at the reference position and the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail, so that the angle theta can be quickly and conveniently obtained. In some embodiments, a doctor can quickly determine the axis of the femoral shaft in the medical image by looking at the medical image, and then can find a position mark parallel to the axis of the femoral shaft, and the angle value X corresponding to the position mark, together with the included angle 5 degrees between the axis of the femoral shaft and the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail, can obtain the included angle theta. Therefore, through a direct observation mode of a doctor, the included angle theta between the expected insertion direction (such as the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail) and the axial direction of the navigation assembly 200 when the navigation assembly 200 is positioned at the reference position can be determined without complex image processing, and the target offset position information can be obtained.

In some embodiments, the desired insertion direction (e.g., the desired approach direction of the desired approach point of the intramedullary nail) and the angle θ may be determined by a medical professional via a marker measurement on the medical image.

For example, referring to fig. 19, in some embodiments, the intended insertion direction (e.g., the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail) may be manually marked on the medical image by a medical staff member (e.g., a doctor), and a position mark parallel to the marked ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail may be measured using a ruler or other measuring tool capable of determining parallelism between lines, and the angle X corresponding to the position mark may be determined as the angle θ between the axial direction of the navigation assembly 200 in the reference position and the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail.

For another example, referring to fig. 20, a medical staff (such as a doctor) may manually mark the axis of the femoral shaft in a medical image by means of a mechanical drawing, and measure and obtain a position mark parallel to the marked axis of the femoral shaft by using a ruler or other measuring tool capable of determining parallelism between lines, because the ideal screw feeding direction of the ideal screw feeding point of the intramedullary nail at the proximal end of the femur is 5 ° outwards of the axis of the femoral shaft so as to adapt to the external offset angle of the main screw, the angle X of the position mark is added with an included angle θ obtained by 5 ° so as to be the included angle θ between the axis direction of the navigation assembly 200 when in the reference position and the ideal screw feeding direction of the ideal screw feeding point of the intramedullary nail.

For another example, the obtained medical image is led into an image workstation, the image processing method is utilized in the image workstation, the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail in the medical image is automatically identified, the position mark parallel to the ideal nail feeding direction of the identified ideal nail feeding point of the intramedullary nail is analyzed and determined from the position marks in the medical image, and the angle X corresponding to the position mark is determined as the included angle theta between the axial direction of the navigation component 200 when the navigation component is at the reference position and the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail.

For another example, the obtained medical image is led into an image workstation, the femoral shaft axis in the medical image is automatically identified by using an image processing method in the image workstation, a position mark parallel to the identified femoral shaft axis is analyzed and determined from all position marks in the medical image, and an angle X corresponding to the position mark and an angle (such as 5 degrees) between the femoral shaft axis and an ideal nail feeding direction of an ideal nail feeding point of an intramedullary nail are combined, so that an angle theta between the axial direction of the navigation assembly 200 at a reference position and the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail is determined, for example, an included angle obtained by adding 5 degrees to the angle X is the included angle theta between the axial direction of the navigation assembly 200 at the reference position and the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail.

The image processing method for identifying the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail and/or the axis of the femoral shaft in the medical image can be realized by adopting a pattern recognition algorithm or a deep learning intelligent algorithm, and the embodiment of the application is not particularly limited.

After obtaining the target offset position information, for example, the included angle θ between the axial direction of the navigation module 200 at the reference position and the ideal screw feeding direction of the ideal screw feeding point of the intramedullary nail, taking the medical staff (such as a doctor) to observe and determine the included angle θ by himself, if the first relative position information is prompted during the medical navigation, the medical staff (such as the doctor) may record the included angle θ by himself, or may input the included angle θ into the navigation module 200 and/or the external processing device 20 and/or the external prompting device 30 and/or the navigation processing device 40. If the second relative position information is presented during medical navigation, the healthcare worker needs to input the included angle θ into the navigation assembly 200 and/or the external processing device 20 and/or the external presentation device 30 and/or the navigation processing apparatus 40.

In some embodiments, taking the example of determining the included angle θ by image processing, the device performing image processing may be the navigation component 200 and/or the external processing device 20 and/or the external prompting device 30 and/or the navigation processing apparatus 40, or may be a device different from the navigation component 200 and/or the external processing device 20 and/or the external prompting device 30 and/or the navigation processing apparatus 40.

If the first relative position information is prompted in the medical navigation process, the device for performing image processing can prompt the included angle theta so that a medical staff (such as a doctor) can know the included angle theta. If the device for performing image processing is different from the device for performing navigation module 200 and/or external processing device 20 and/or external presentation device 30 and/or navigation processing device 40, the device for performing image processing may transmit the included angle θ to navigation module 200 and/or external processing device 20 and/or external presentation device 30 and/or navigation processing device 40 by wired or wireless method, or may input the included angle θ to navigation module 200 and/or external processing device 20 and/or external presentation device 30 and/or navigation processing device 40 by the medical staff after the medical staff knows the included angle.

If the device for performing image processing is different from the device for performing navigation module 200 and/or external processing device 20 and/or external presentation device 30 and/or navigation processing device 40, the device for performing image processing needs to provide the angle θ to the navigation module 200 and/or external processing device 20 and/or external presentation device 30 and/or navigation processing device 40, for example, the device for performing image processing transmits the angle θ to the navigation module 200 and/or external processing device 20 and/or external presentation device 30 and/or navigation processing device 40 through a wired or wireless manner, or the device for performing image processing may provide the angle θ to the medical staff, and then the medical staff inputs the angle θ to the navigation module 200 and/or external processing device 20 and/or external presentation device 30 and/or navigation processing device 40.

Taking the detachable connection of the navigation module 200 and the visualization and positioning module 100 as an example, the navigation module 200 is then separated from the visualization and positioning module 100, the visualization and positioning module 100 is taken away from the proximal body surface of the femur on the affected side of the patient, and the navigation module 200 is fixed to an orthopedic operation tool (such as a guide pin or a holder or an electric drill, and the guide pin is taken as an example in the following embodiments).

Taking a manner of inserting a guide pin by bare hands as an example, a schematic diagram of fixing the navigation module 200 to the guide pin is shown in fig. 21, where a groove may be formed at the bottom of the navigation module 200 to directly fix the navigation module 200 to the guide pin, or the navigation module 200 may be fixed to the guide pin by other manners. If a holder or a drill is selected for inserting the guide pin, the navigation module 200 can be directly mounted on the holder or the drill by magnetic attraction so as to fix the navigation module 200 to the holder or the drill, and a schematic diagram of fixing the navigation module 200 to the holder or the drill is shown in fig. 22.

The patient lies on his back with the apex ridge contour of the greater trochanter of the patient in a generally vertical orientation, which can be manually touched by the physician from the incision, as shown in phantom in the enlarged portion of fig. 23. The doctor holds the guide pin fixed with the navigation assembly 200 and enables the axial direction of the guide pin to be approximately positioned on the horizontal plane, and the pitch angle value on the screen of the navigation assembly 200 or the pitch angle value provided by the navigation assembly 20 to the external prompting device 30 and/or the navigation processing device 40 can assist the doctor to check whether the guide pin is approximately kept horizontal.

The physician then moves the orthopaedic surgical tool with the navigation assembly 200 secured thereto, in combination with the navigation assembly 200 and/or the external prompting device 30 and/or the navigation processing means 40, to move the orthopaedic surgical tool to the desired intramedullary nail insertion point.

During the movement of the orthopaedic surgical tool, the sensors 201 of the navigation assembly 200 measure in real time to obtain real-time location information.

Taking as an example the navigation of the orthopaedic surgical tool to the ideal intramedullary nail insertion point by prompting the first relative position information, the following is exemplified in connection with the navigation process of the respective medical navigation device 10 as described above.

Taking the medical navigation device 10 shown in fig. 1 as an example:

during movement of the orthopaedic surgical tool, the navigation assembly 200 determines a height difference ΔH of the real-time position of the sensor 201 relative to the reference position based on the real-time position information measured by the sensor 201.

The guide needle tip is placed on the vertex of the large rotor vertex ridge profile closest to the abdomen side, and the navigation module 200 determines the height difference Δh1 of the real-time position of the sensor 201 with respect to the reference position based on the real-time position information measured by the sensor 201 (if the navigation module 200 performs the zeroing process on the sensor 201, the height difference Δh1 may be the first reference height value H1 in practice).

The tip of the guide needle is placed on the vertex of the ridge profile of the vertex of the large rotor closest to the back side, and at this time, the navigation component 200 determines, based on the real-time position information measured by the sensor 201, the height difference Δh2 of the real-time position of the sensor 201 with respect to the reference position (if the navigation component 200 performs the zeroing processing on the sensor 201, the height difference Δh2 may be actually the second reference height value H2).

The physician holds the lead approximately horizontally with its tip moving on the greater trochanter apex ridge profile and the difference in height Δh displayed in real time by the navigation assembly 200 will vary from difference in height Δh1 to difference in height Δh2. If the navigation module 200 performs the zeroing process on the sensor 201, the height H that is actually prompted in real time will change between the height H1 and H2.

Taking the medical navigation device 10 shown in fig. 2 as an example:

during movement of the orthopaedic surgical tool, the navigation assembly 200 transmits real-time positional information measured in real-time by the sensor 201 to the external processing device 20. The external processing device 20 determines the height difference Δh of the real-time position of the sensor 201 with respect to the reference position based on the real-time position information measured by the sensor 201.

Wherein, when the tip of the guide pin is placed on the vertex of the ridge profile of the vertex of the large rotor closest to the abdomen side, the external processing device 20 determines the height difference Δh1 of the real-time position of the sensor 201 with respect to the reference position based on the real-time position information measured by the sensor 201 (if the sensor 201 is zeroed, the height difference Δh1 may be the first reference height value H1 in practice).

The tip of the guide needle is placed on the vertex of the ridge profile of the vertex of the large rotor closest to the back side, and at this time, the external processing device 20 determines the height difference Δh2 of the real-time position of the sensor 201 with respect to the reference position based on the real-time position information measured by the sensor 201 (if the sensor 201 is zeroed, the height difference Δh2 may actually be the second reference height value H2).

The height difference Δh determined by the external processing device 20 is transmitted to the navigation module 200 for prompting. The physician holds the lead approximately horizontally with its tip moving on the greater trochanter apex ridge profile and the real-time hinted difference in height Δh of the navigation assembly 200 will vary between difference in height Δh1 and difference in height Δh2. If the navigation module 200 performs the zeroing process on the sensor 201, the height H that is actually prompted in real time will change between the height H1 and H2.

Taking the medical navigation device 10 shown in fig. 3 as an example:

the physician holds the lead approximately horizontally with its tip moving over the greater trochanter apex ridge profile, and the navigation assembly 200 determines the height difference Δh and transmits the determined height difference Δh to the external prompting device 30 for prompting. The height difference Δh prompted in real time by the external prompting device 30 will vary between the height differences Δh1 to Δh2. If the sensor 201 is zeroed, the height H actually presented in real time will change between the height values H1 to H2. The manner of determining the height difference Δh is the same as that of the medical navigation device 10 shown in fig. 1, and will not be described here.

Taking the medical navigation device 10 shown in fig. 4 as an example:

during the movement of the orthopaedic surgical tool, the navigation assembly 200 transmits real-time location information measured in real-time by the sensor 201 to the navigation processing device 40. The navigation processing means 40 determines the height difference Δh in real time based on the same manner as the external processing device 20, and presents the determined height difference Δh. The navigation processing device 40 may prompt the height difference Δh by itself, or may prompt a prompt device different from the navigation processing device 40, for example, in combination with the embodiment shown in fig. 3, transmit the prompt signal to the external prompt device 30 in the embodiment shown in fig. 3. The doctor holds the guide pin approximately horizontally so that the tip moves on the ridge profile of the vertex of the large rotor, the height difference delta H prompted in real time changes between the height difference delta H1 and the height difference delta H2, and if the navigation component 200 carries out zero-resetting treatment on the sensor 201, the height value H prompted in real time changes between the height values H1 and H2.

Wherein, during the navigation of the medical navigation device 10 and/or the navigation processing device 40 of the embodiments described above:

if the doctor selects the midpoint of the greater trochanter apex ridge contour as the surgical site, when the indicated height difference Δh is (Δh1+Δh2)/2, or when the sensor 201 is zeroed, the indicated height value H is (h1+h2)/2, the midpoint position of the greater trochanter apex ridge contour, that is, the ideal screw feeding position of the ideal screw feeding point of the intramedullary nail. Similarly, if the doctor selects the front 1/3 of the ridge profile of the greater trochanter vertex as the surgical site, the ideal screw feeding position of the ideal screw feeding point of the intramedullary nail is obtained when the presented height difference Δh is (Δh2- Δh1)/3+Δh1 (the height difference may be rounded upward or downward if displayed as an integer value, the same applies to the following embodiments), or when the sensor 201 is zeroed, the presented height value H is (H2-H1)/3+h1.

In this way, the ideal nail feeding position of the ideal nail feeding point of the intramedullary nail can be automatically judged and selected by a doctor according to the actual position requirement, so that the method can be suitable for selecting different specific requirements of different nail feeding positions of intramedullary nail products.

After the guide pin reaches the ideal nail feeding position of the ideal nail feeding point of the intramedullary nail, the angle can be adjusted so that the needle feeding direction of the guide pin reaches the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail.

During adjustment, a doctor keeps the ideal nail feeding position of the needle guiding tip at the ideal nail feeding point of the intramedullary nail unchanged, and adjusts the outward deflection angle of the guide needle:

taking the medical navigation device 10 shown in fig. 1 as an example:

the navigation component 200 determines and prompts an external offset angle of the real-time position of the sensor 201 relative to the reference position based on the real-time position information measured by the sensor 201.

Taking the medical navigation device 10 shown in fig. 2 as an example:

the external processing device 20 determines an external offset angle of the real-time position of the sensor 201 relative to the reference position based on the real-time position information measured by the sensor 201, and transmits the external offset angle to the navigation module 200 for prompting.

Taking the medical navigation device 10 shown in fig. 3 as an example:

the navigation module 200 determines an external offset angle of the real-time position of the sensor 201 with respect to the reference position based on the real-time position information measured by the sensor 201, and transmits the external offset angle to the external presentation device 30 for presentation.

Taking the medical navigation device 10 shown in fig. 4 as an example:

the navigation processing means 40 determines an external angle of the real-time position of the sensor 201 with respect to the reference position based on the real-time position information measured by the sensor 201 and presents the external angle or sends the external angle to a presentation device different from the navigation processing means 40 for presentation, for example, in combination with the embodiment shown in fig. 3, to the external presentation device 30 in the embodiment shown in fig. 3.

in the process that the doctor keeps the ideal nail feeding position of the needle guiding tip at the ideal nail feeding point of the intramedullary nail unchanged and adjusts the external deflection angle of the guide needle, when the external deflection angle prompted by the navigation component 200 and/or the external prompting device 30 and/or the navigation processing device 40 is the determined included angle theta between the axis direction of the navigation component 200 and the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail, the needle feeding direction of the guide needle reaches the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail at the moment, as shown in fig. 24. The doctor can refer to the pitch angle of the prompt, and insert the guide pin after the front dip angle of the guide pin is properly adjusted.

Taking the example of navigating the orthopaedic surgical tool to the ideal intramedullary nail insertion point by prompting the second relative positional information, the following is illustrative in connection with the navigation process of each medical navigation device 10 as described above.

Taking the medical navigation device 10 shown in fig. 1 as an example:

during movement of the orthopaedic surgical tool, the navigation assembly 200 prompts the height value in the real-time positional information measured in real-time by the sensor 201. The tip of the guide needle is placed on the vertex of the ridge profile of the vertex of the greater trochanter closest to the ventral side, in some embodiments, the doctor issues a recording instruction by operating the navigation assembly 200 or by voice input, etc., the navigation assembly 200 records the first reference height value h1 measured by the sensor 11 at this time, in other embodiments, the navigation assembly 200 prompts the height value, and the medical staff (e.g., doctor) can record the first reference height value h1 measured by the sensor 11 at this time by himself.

Placing the tip of the guide needle on the apex of the ridge profile of the apex of the greater rotor closest to the back side, in some embodiments, the physician issues a recording instruction by operating the navigation assembly 200 or voice input, etc., the navigation assembly 200 records the second reference height value h2 measured by the sensor 11 at this time. In other embodiments, the navigation module 200 prompts the height value, and medical staff (e.g., a doctor) can self-record the second reference height value h2 measured by the sensor 11.

Subsequently, in the case where the navigation assembly 200 records the first reference height value H1 and the second reference height value H2, the navigation assembly 200 determines a height value H of an ideal nail feeding position of an ideal nail feeding point of the intramedullary nail in a direction perpendicular to the horizontal plane based on the first reference height value H1 and the second reference height value H2, and records the height value H. In the case that the medical staff (e.g., doctor) self-records the first reference height value H1 and the second reference height value H2, the medical staff (e.g., doctor) self-determines the height value H of the ideal nail feeding position of the ideal nail feeding point of the intramedullary nail in the direction perpendicular to the horizontal plane based on the self-recorded first reference height value H1 and the second reference height value H2, and then inputs the determined height value H into the navigation assembly 200 to be recorded by the navigation assembly 200.

If the doctor selects the middle point of the peak ridge outline of the greater trochanter as the operation position point, the height value H of the ideal nail feeding position of the ideal nail feeding point of the intramedullary nail is (h1+h2)/2. Similarly, if the doctor selects the position 1/3 of the anterior position of the ridge profile of the apex of the greater trochanter as the operation position point, the height value H of the ideal nail feeding position of the ideal nail feeding point of the intramedullary nail is (H2-H1)/3+h1.

The physician holds the lead approximately horizontally with its tip moving over the greater trochanter apex ridge profile, and during the movement, the navigation assembly 200 determines a second displacement offset in conjunction with the real-time positional information of the sensor 201, and the recorded height value H, and prompts the second displacement offset.

Taking the medical navigation device 10 shown in fig. 2 as an example:

during movement of the orthopaedic surgical tool, the navigation assembly 200 transmits real-time positional information measured in real-time by the sensor 201 to the external processing device 20.

The tip of the guide needle is placed on the vertex of the ridge profile of the vertex of the greater trochanter closest to the abdomen side, and the external processing device 20 records the first reference height value h1 measured by the sensor 11 at this time based on a recording instruction issued by a medical staff through operating the external processing device 20 or voice input or the like, and in other embodiments, the navigation assembly 200 and/or the external processing device 20 may prompt the height value, and the medical staff (such as a doctor) may record the first reference height value h1 measured by the sensor 11 at this time by himself.

The tip of the guide needle is placed on the vertex of the ridge profile of the vertex of the large rotor closest to the back side, at this time, the external processing device 20 records the second reference height value h2 measured by the sensor 11 at this time based on a recording instruction issued by a medical staff through operating the external processing device 20 or voice input, etc., and in other embodiments, the navigation component 200 and/or the external processing device 20 may prompt the height value, and the medical staff (such as a doctor) may record the second reference height value h2 measured by the sensor 11 at this time by himself.

Subsequently, in the case where the external processing apparatus 20 records the first reference height value H1 and the second reference height value H2, the external processing apparatus 20 determines a height value H of an ideal nail feeding position of an ideal nail feeding point of the intramedullary nail in a direction perpendicular to the horizontal plane based on the first reference height value H1 and the second reference height value H2, and records the height value H. In the case where the medical staff (e.g., doctor) self-records the first reference height value H1 and the second reference height value H2, the medical staff (e.g., doctor) self-determines the height value H of the ideal nail feeding position of the ideal nail feeding point of the intramedullary nail in the direction perpendicular to the horizontal plane based on the self-recorded first reference height value H1 and second reference height value H2, and then inputs the determined height value H to the external processing device 20, which is recorded by the external processing device 20.

The physician holds the lead approximately horizontally with its tip moving over the greater trochanter apex ridge profile, and during this movement, the navigation assembly 200, in combination with the real-time positional information of the sensor 201, and the recorded height value H, determines a second displacement offset and prompts the second displacement offset.

Taking the medical navigation device 10 shown in fig. 3 as an example:

the physician holds the lead approximately horizontally with its tip moving over the greater trochanter apex ridge profile, and the navigation assembly 200 determines a second displacement offset and transmits the determined second displacement offset to the external prompting device 30 for prompting. The manner in which the navigation module 200 determines the second displacement deviation is the same as the manner in which the navigation module 200 of the medical navigation device 10 shown in fig. 1 determines the second displacement deviation, and will not be described herein.

Taking the medical navigation device 10 shown in fig. 4 as an example:

during the movement of the orthopaedic surgical tool, the navigation assembly 200 transmits real-time location information measured in real-time by the sensor 201 to the navigation processing device 40. The navigation processing device 40 determines the second displacement deviation in real time and prompts the second displacement deviation based on the same way as the external processing device 20, wherein the navigation processing device 40 may prompt the second displacement deviation by itself, or may prompt the second displacement deviation to a prompt device different from the navigation processing device 40, for example, in combination with the embodiment shown in fig. 3, and send the second displacement deviation to the external prompt device 30 in the embodiment shown in fig. 3.

Wherein, during the navigation of the medical navigation device 10 and/or the navigation processing device 40 of the embodiments described above, when the second displacement deviation prompted in real time is 0, the ideal nail feeding position reaching the ideal nail feeding point of the intramedullary nail is determined.

In this way, after the ideal nail feeding position of the ideal nail feeding point of the intramedullary nail is selected and determined, when the second displacement deviation prompted in real time is 0 in the process of moving the orthopedic operation tool, the ideal nail feeding position reaching the ideal nail feeding point of the intramedullary nail can be determined intuitively and conveniently.

taking the medical navigation device 10 shown in fig. 1 as an example:

the navigation assembly 200 determines, in real time, a second angular deviation of the real-time position of the sensor 201 relative to the target position, i.e. an angle between a specified direction (e.g. the axial direction of the navigation assembly 200) when the sensor 201 is in the real-time position and an ideal nail feeding direction of an ideal nail feeding point of the intramedullary nail, based on the real-time position information measured by the sensor 201, and prompts the second angular deviation.

Taking the medical navigation device 10 shown in fig. 2 as an example:

the external processing device 20 determines, in real time, a second angular deviation of the real-time position of the sensor 201 relative to the target position, that is, an angle between a specified direction (for example, an axial direction of the navigation assembly 200) in which the sensor 201 is located at the real-time position and an ideal nail feeding direction of an ideal nail feeding point of the intramedullary nail, based on the real-time position information measured by the sensor 201, and sends the second angular deviation to the navigation assembly 200 for prompting.

Taking the medical navigation device 10 shown in fig. 3 as an example:

the navigation module 200 determines, in real time, a second angular deviation of the real-time position of the sensor 201 relative to the target position, that is, an angle between a specified direction (for example, an axial direction of the navigation module 200) in which the sensor 201 is located at the real-time position and an ideal nail feeding direction of an ideal nail feeding point of the intramedullary nail, based on the real-time position information measured by the sensor 201, and sends the second angular deviation to the external prompting device 30 for prompting.

Taking the medical navigation device 10 shown in fig. 4 as an example:

the navigation processing means 40 determines in real time a second angular deviation of the real-time position of the sensor 201 with respect to the target position, i.e. the angle between the specified direction of the real-time position of the sensor 201 (e.g. the axial direction of the navigation assembly 200) and the ideal screw feeding direction of the ideal screw feeding point of the intramedullary screw, based on the real-time position information measured by the sensor 201, and prompts the second angular deviation, or sends the second angular deviation to a prompting device different from the navigation processing means 40 for prompting, e.g. in combination with the embodiment shown in fig. 3, to the external prompting device 30 in the embodiment shown in fig. 3.

in the process that the doctor keeps the ideal nail feeding position of the needle guiding tip at the ideal nail feeding point of the intramedullary nail unchanged and adjusts the external deflection angle of the guide needle, when the second angle deviation prompted by the navigation component 200 and/or the external prompting device 30 and/or the navigation processing device 40 is 0, the needle feeding direction of the guide needle reaches the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail, as shown in fig. 24. The doctor can refer to the pitch angle of the prompt, and insert the guide pin after the front dip angle of the guide pin is properly adjusted.

Based on the medical navigation device 10 and/or the navigation processing device 40 provided by the embodiments of the present application, the first height deviation and/or the first angle deviation and/or the second height deviation and/or the second angle deviation of the real-time position to the reference position are/is followed and prompted based on the sensor, so that the selection of the ideal nail feeding position and the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail is realized, the accurate positioning of the ideal nail feeding position and the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail during operation is fundamentally realized, and real-time position information and angle information are provided for doctors, so that the guide needle can be driven successfully once without adjusting the guide needle for driving for many times. Moreover, the medical navigation device 10 provided by the embodiments of the present application is small and easy to use, can greatly shorten the operation time, reduce the X-ray radiation amount of doctors and patients, and improve the operation quality and operation efficiency.

It should be understood that in the description of the embodiments described above, the description is given taking the example that the navigation module 200 presents the first relative position information and/or the second relative position information, or the external presentation device 30/the navigation processing device 40 presents the first relative position information and/or the second relative position information, in the actual technology implementation process, based on actual technology selection and needs, two or three of the navigation module 200, the external presentation device 30 and the navigation processing device 40 may also present the first relative position information and/or the second relative position information at the same time. When two or three of the navigation module 200, the external presentation device 30, and the navigation processing device 40 simultaneously present the first relative position information and/or the second relative position information, the content of the presentation of the navigation module 200, the external presentation device 30, and the navigation processing device 40 may or may not be identical, and the embodiment of the application is not limited specifically.

Based on the medical navigation device of each embodiment as described above, the embodiment of the application further provides a navigation method of the medical navigation device for guiding an orthopedic operation tool, wherein the medical navigation device comprises a navigation component and a developing and positioning component, and the navigation component is provided with a sensor. The developing and positioning assembly is provided with a position mark which can be visually displayed in the medical image.

As shown in fig. 25, a navigation method of a medical navigation device for guiding an orthopedic surgical tool in some embodiments includes:

step S101: upon receiving a trigger instruction, reference position information of a sensor of the navigation component measured when the sensor is at a reference position is recorded in response to the trigger instruction.

When the sensor is positioned at the reference position, the sensor and a position mark of the developing and positioning assembly have a predetermined relative position relation, the position mark is used for determining target offset position information in combination with the predetermined relative position relation, and the target offset position information is used for indicating the relative position relation between the reference position and the target position; wherein the target location may be determined in connection with the type of orthopaedic surgery, such as the ideal approach point for an intramedullary nail.

Step S102: and acquiring real-time position information of the sensor in a state that the sensor is fixed with the orthopedic operation tool, and acquiring first relative position information and/or second relative position information based on the real-time position information.

The first relative position information is the relative position information between the real-time position of the sensor and the reference position, and the real-time position is determined by the real-time position information; the second relative position information is the relative position information between the real-time position and a target position (e.g., an ideal intramedullary nail feeding point), and is determined by the real-time position information and target offset position information.

Step S103: and prompting the first relative position information and/or the second relative position information.

Wherein the first relative position information is combined with the target offset position information and/or the second relative position information may be used to assist in guiding the orthopaedic surgical tool to a target location (e.g., an ideal intramedullary nail insertion point).

As shown in fig. 26, a navigation method of a medical navigation device for guiding an orthopedic surgical tool in some embodiments includes:

step S201: real-time location information measured by a sensor of the navigation assembly fixed with the orthopaedic surgical tool is acquired.

Step S202: and sending the real-time position information to an external processing device.

Step S203: and receiving the first relative position information and/or the second relative position information fed back by the external processing equipment, and prompting the first relative position information and/or the second relative position information.

The first relative position information is relative position information between a real-time position of the sensor and a reference position where the sensor is located in advance, the real-time position is determined by the real-time position information, the reference position is determined by pre-recorded reference position information, the reference position information comprises first reference position information and/or second reference position information, the first reference position information is position information which is obtained by the navigation component in response to a trigger instruction and is measured by the sensor and sent to the external processing equipment, and the second reference position information is preset position information which is obtained by the external processing equipment in response to the trigger instruction; the second relative position information is the relative position information between the real-time position of the sensor and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by an expected insertion position and/or an expected insertion direction of the orthopaedic surgical tool in a human body.

As shown in fig. 27, a navigation method of a medical navigation device for guiding an orthopedic surgical tool in some embodiments includes:

step S301: upon receiving a trigger instruction, reference position information of a sensor of the navigation component measured when the sensor is at a reference position is recorded in response to the trigger instruction.

Step S302: and acquiring real-time position information of the sensor in a state that the sensor is fixed with the orthopedic operation tool, and acquiring first relative position information and/or second relative position information based on the real-time position information.

The first relative position information is the relative position information between the real-time position of the sensor and the reference position, and the real-time position is determined by the real-time position information; the second relative position information is the relative position information between the real-time position and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by an expected insertion position and/or an expected insertion direction of the orthopaedic surgical tool in a human body.

Step S303: transmitting the first relative position information and/or the second relative position information to external prompting equipment, and prompting the first relative position information and/or the second relative position information by the external prompting equipment.

As shown in fig. 28, the navigation method of the medical navigation device for guiding an orthopaedic surgical tool in some embodiments may be performed by the navigation processing device 40, wherein the navigation component 200 of the medical navigation device 10 is communicatively connected to the navigation processing device 40, the method comprising:

step S401: and acquiring real-time position information which is transmitted by the navigation component and measured by the sensor in a state that the sensor is fixed with the orthopedic operation tool.

Step S402: and acquiring the first relative position information and/or the second relative position information based on the real-time position information.

The first relative position information is relative position information between a real-time position of the sensor and a reference position where the sensor is located in advance, the real-time position is determined by the real-time position information, the reference position is determined by pre-recorded reference position information, the reference position information comprises first reference position information and/or second reference position information, the first reference position information is position information measured by the sensor, which is obtained by the navigation component in response to a trigger instruction, and sent to the navigation processing device, and the second reference position information is preset position information obtained by the navigation processing device in response to the trigger instruction; the second relative position information is the relative position information between the real-time position and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by an expected insertion position and/or an expected insertion direction of the orthopaedic surgical tool in a human body.

Step S403: and prompting the first relative position information and/or the second relative position information.

In some embodiments, the navigation method of the medical navigation device in the embodiments described above may be applied to an orthopedic operation requiring insertion of an intramedullary nail, for example, an orthopedic operation of a proximal femur fracture, where the medical navigation device may be a medical navigation device for navigating an intramedullary nail insertion point, the target position may be an ideal intramedullary nail insertion point, the expected insertion position may be an ideal nail insertion position of the ideal intramedullary nail insertion point, and the expected insertion direction may be an ideal nail insertion direction of the ideal nail insertion point of the intramedullary nail.

In some embodiments, the navigation assembly is activated when a first contact on the navigation assembly is in contact with a second contact on the developer positioning assembly.

In some embodiments, the trigger instruction includes an activation signal generated when the first contact is in contact with the second contact.

In some embodiments, when the contact on the navigation component is in contact with the contact on the developing and positioning component, and the navigation component is activated, the reference position of the navigation component is recorded after the trigger instruction is received.

In some embodiments, the reference position information is position information measured by the sensor, which is obtained in response to the trigger instruction.

In some embodiments, the reference position information is position information measured by the sensor after initializing the sensor in response to the trigger command. In some embodiments, the initial position information may be zero position information. The zero position information may mean that the values of the information related to the position are all set to 0, for example, the height value is 0, etc.

The first displacement bias may include: the distance between the real-time position of the sensor and the reference position in a direction perpendicular to the horizontal plane. In some embodiments, the first displacement offset may also be referred to as a height difference, as shown in fig. 11.

In some embodiments, the first angular offset may include: after the specified direction of the sensor fixed with the orthopedic operation tool and the specified direction of the sensor when in the reference position are projected to the same plane, the included angle between the two projections on the plane is shown in fig. 12. In some embodiments, the first angular offset may also be referred to as an outside offset angle. In some embodiments, the designated direction of the sensor may be the axial direction of the navigation assembly, and the same plane may be a horizontal plane, which is the same in the following embodiments.

In some embodiments, the second relative positional information includes a second positional deviation and/or a second angular deviation between the real-time position and a target position (e.g., an intramedullary nail ideal feed point) determined by an intended insertion position (e.g., an ideal feed position of the intramedullary nail ideal feed point) and/or an intended insertion direction (e.g., an ideal feed direction of the intramedullary nail ideal feed point) of the orthopaedic surgical tool in the human body.

The second angular deviation includes: and projecting the appointed direction of the sensor at the real-time position and the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail to the same plane, and forming an included angle between two projections on the plane. In some embodiments, the same plane may be a horizontal plane.

Wherein the desired direction of insertion (e.g., the desired direction of insertion of the desired point of insertion of the intramedullary nail) may be determined in various possible ways.

In some embodiments, the desired insertion direction (e.g., the desired screw-in direction of the desired screw-in point of the intramedullary nail) is the user-entered insertion direction. For example, when the medical navigation device 10 is located at the reference position, a medical image is captured, an intended insertion direction (e.g., an ideal nail feeding direction of an ideal nail feeding point of an intramedullary nail) is manually marked on the medical image by a medical staff, and the direction manually marked by the medical staff is taken as the intended insertion direction (e.g., the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail).

In some embodiments, the desired insertion direction (e.g., the desired screw-in direction of the desired screw-in point of the intramedullary screw) is obtained by analyzing a medical image taken while the medical navigation device is in the reference position.

The second displacement offset includes: in a direction perpendicular to the horizontal plane, the sensor is located at a distance between the real-time position and the target position, e.g. the ideal screw feeding position of the ideal screw feeding point of the intramedullary nail.

The intended insertion position may be determined based on a predetermined insertion region, which may be a region for determining a target position, such as an ideal intramedullary nail insertion point of the proximal femur, and may be a greater trochanter apex ridge contour. Specific positional information of the intended insertion location may be determined during movement of the orthopaedic surgical tool that is fixed with the navigation assembly.

In some embodiments, the height value of the intended insertion location (e.g., the ideal screw insertion location of the ideal screw insertion point) in a direction perpendicular to the horizontal plane is determined by a first reference height value that is the height value of the sensor in a direction perpendicular to the horizontal plane when the insertion end of the orthopaedic surgical tool is at the first side vertex of the predetermined insertion area and a second reference height value that is the height value of the sensor in a direction perpendicular to the horizontal plane when the insertion end of the orthopaedic surgical tool is at the second side vertex of the predetermined insertion area. Taking an ideal nail feeding point of the intramedullary nail at the proximal end of the femur as an example, the first side vertex specifically may refer to the vertex of the greater trochanter vertex ridge profile closest to the ventral side, and the second side vertex specifically may refer to the vertex of the greater trochanter vertex ridge profile closest to the dorsal side.

In some embodiments, in the method of the foregoing embodiments, the method may further include:

acquiring a pitch angle between the bottom surface of the navigation assembly and a horizontal plane, which is measured by a sensor of the navigation assembly;

and prompting the pitch angle.

and transmitting the pitch angle to external prompt equipment for prompt.

providing error prompt information, wherein the error prompt information is information generated when the accumulated time length is longer than a preset time length, and/or the error prompt information is information generated when the calculated error is greater than an error threshold value, and the accumulated time length is time length from when the reference position information is recorded or when the sensor is calibrated last time.

For a specific implementation of the navigation method of the medical navigation device, reference may be made to the description of the medical navigation device and/or the navigation processing device in the above embodiments.

It should be understood that, although the steps in the flowcharts referred to above are shown in order as indicated by the arrows, these steps are not necessarily performed in order as indicated by the arrows. The steps are not strictly limited to the order of execution unless explicitly recited herein, and the steps may be executed in other orders. Moreover, at least some of the steps in the flowcharts may include a plurality of steps or stages that are not necessarily performed at the same time, but may be performed at different times, and the order of execution of the steps or stages is not necessarily sequential, but may be performed in rotation or alternately with at least a portion of the steps or stages in other steps or other steps.

In one embodiment, an electronic device is provided, the internal structure of which may be as shown in fig. 29. The electronic device includes a processor, a memory, a communication interface, a display screen, and an input device connected by a system bus. Wherein the processor is configured to provide computing and control capabilities. The memory of the electronic device includes a nonvolatile storage medium and an internal memory. The non-volatile storage medium stores an operating system and a computer program. The internal memory provides an environment for the operation of the operating system and computer programs in the non-volatile storage media. The communication interface of the electronic device is used for carrying out wired or wireless communication with an external terminal, and the wireless mode can be realized through WIFI, an operator network, NFC (near field communication) or other technologies. The computer program is executed by a processor to implement a navigation method of a medical navigation device as described above. The display screen of the electronic equipment can be a liquid crystal display screen or an electronic ink display screen, and the input device of the electronic equipment can be a touch layer covered on the display screen, can also be keys, a track ball or a touch pad arranged on the shell of the electronic equipment, and can also be an external keyboard, a touch pad or a mouse and the like.

In an embodiment, there is also provided an electronic device including a memory and a processor, the memory storing a computer program, the processor implementing the steps of the navigation method of the medical navigation apparatus of any of the embodiments described above when the computer program is executed.

In an embodiment, a computer readable storage medium is provided, storing a computer program which, when executed by a processor, implements the steps of the navigation method of the medical navigation device of any of the embodiments described above.

In one embodiment, a computer program product or computer program is provided that includes computer instructions stored in a computer readable storage medium. The processor of the computer device reads the computer instructions from the computer-readable storage medium, and the processor executes the computer instructions, so that the computer device performs the steps of the navigation method of the medical navigation apparatus of any of the above embodiments.

Those skilled in the art will appreciate that implementing all or part of the above described methods in accordance with the embodiments may be accomplished by way of a computer program stored on a non-transitory computer readable storage medium, which when executed, implements the processes of the embodiments comprising the methods described above. Any reference to memory, storage, database, or other medium used in embodiments provided herein may include at least one of non-volatile and volatile memory. The nonvolatile Memory may include Read-Only Memory (ROM), magnetic tape, floppy disk, flash Memory, optical Memory, or the like. Volatile memory can include random access memory (Random Access Memory, RAM) or external cache memory. By way of illustration, and not limitation, RAM can be in the form of a variety of forms, such as static random access memory (Static Random Access Memory, SRAM) or dynamic random access memory (Dynamic Random Access Memory, DRAM), and the like.

In some embodiments, a medical navigation system is provided, the medical navigation system comprising: an orthopaedic surgical tool, and a medical navigation device and/or navigation processing device in any of the embodiments described above.

The technical features of the above embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the application. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application. Accordingly, the scope of protection of the present application is to be determined by the appended claims.

Claims

The medical navigation device for the intramedullary nail feeding point navigation is characterized by comprising a navigation component and a development positioning component, wherein the navigation component is provided with a sensor;

The developing and positioning assembly is provided with a position mark which can be visually displayed in the medical image;

the navigation component is used for responding to a trigger instruction, recording the reference position information of the sensor measured by the sensor when the sensor is at the reference position, acquiring the real-time position information of the sensor in a state that the sensor is fixed with an orthopedic operation tool, acquiring first relative position information and/or second relative position information based on the real-time position information, and prompting the first relative position information and/or the second relative position information; the first relative position information is relative position information between a real-time position of the sensor and the reference position, and the real-time position is determined by the real-time position information; the second relative position information is the relative position information between the real-time position and an ideal nail feeding point of the intramedullary nail, and is determined by the real-time position information and target offset position information;

when the sensor is positioned at the reference position, the sensor and the position mark of the developing and positioning assembly have a predetermined relative position relation; the position identifier is used for determining the target offset position information in combination with the predetermined relative position relationship, and the target offset position information is used for indicating the relative position relationship between the reference position and the ideal nail feeding point of the intramedullary nail;

The first relative position information in combination with the target offset position information and/or the second relative position information may be used to assist in guiding the orthopaedic surgical tool to move to the ideal intramedullary nail insertion point.
A medical navigation device for guiding an orthopaedic surgical tool, comprising a navigation assembly and a visualization and positioning assembly, the navigation assembly being provided with a sensor;

the developing and positioning assembly is provided with a position mark which can be visually displayed in the medical image;

the navigation component is used for responding to a trigger instruction, recording the reference position information of the sensor measured by the sensor when the sensor is at the reference position, acquiring the real-time position information of the sensor in a state that the sensor is fixed with an orthopedic operation tool, acquiring first relative position information and/or second relative position information based on the real-time position information, and prompting the first relative position information and/or the second relative position information; the first relative position information is relative position information between a real-time position of the sensor and the reference position, and the real-time position is determined by the real-time position information; the second relative position information is relative position information between the real-time position and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by an expected insertion position and/or an expected insertion direction of the orthopedic operation tool in a human body;

When the sensor is positioned at the reference position, the sensor and the position mark of the developing and positioning assembly have a predetermined relative position relation; the position identifier is used for determining the target offset position information in combination with the predetermined relative position relationship, and the target offset position information is used for indicating the relative position relationship between the reference position and the target position;

the first relative position information in combination with the target offset position information and/or the second relative position information may be used to assist in guiding the orthopaedic surgical tool to move to the target location.
A medical navigation device for guiding an orthopaedic surgical tool, comprising a navigation assembly and a visualization and positioning assembly, the navigation assembly being provided with a sensor;

the developing and positioning assembly is provided with a position mark which can be visually displayed in the medical image;

the navigation component is used for sending the real-time position information measured by the sensor to external processing equipment in a state that the sensor is fixed with the orthopedic operation tool, receiving first relative position information and/or second relative position information fed back by the external processing equipment and prompting the first relative position information and/or the second relative position information; the first relative position information is relative position information between a real-time position of the sensor and a reference position where the sensor is located in advance, the real-time position is determined by the real-time position information, the reference position is determined by pre-recorded reference position information, the reference position information comprises first reference position information and/or second reference position information, the first reference position information is position information which is obtained by the navigation component in response to a trigger instruction and is measured by the sensor and sent to the external processing device, and the second reference position information is preset position information obtained by the external processing device in response to the trigger instruction; the second relative position information is the relative position information between the real-time position of the sensor and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by the expected insertion position and/or the expected insertion direction of the orthopedic operation tool in the human body;

When the sensor is positioned at the reference position, the sensor and the position mark of the developing and positioning assembly have a predetermined relative position relation; the position identifier is used for determining the target offset position information in combination with the predetermined relative position relationship, and the target offset position information is used for indicating the relative position relationship between the reference position and the target position;

the first relative position information in combination with the target offset position information and/or the second relative position information may be used to assist in guiding the orthopaedic surgical tool to move to the target location.
A medical navigation device for guiding an orthopaedic surgical tool, comprising a navigation assembly and a visualization and positioning assembly, the navigation assembly being provided with a sensor;

the developing and positioning assembly is provided with a position mark which can be visually displayed in the medical image;

the navigation component is used for responding to a trigger instruction, recording reference position information when the sensor is positioned at a reference position, acquiring real-time position information of the sensor in a state that the sensor is fixed with an orthopedic operation tool, acquiring first relative position information and/or second relative position information based on the real-time position information, transmitting the first relative position information and/or the second relative position information to external prompting equipment, and prompting the first relative position information and/or the second relative position information by the external prompting equipment; the first relative position information is the relative position information between the real-time position of the sensor and the reference position, and the real-time position is determined by the real-time position information; the second relative position information is relative position information between the real-time position and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by an expected insertion position and/or an expected insertion direction of the orthopedic operation tool in a human body;

When the sensor is positioned at the reference position, the sensor and the position mark of the developing and positioning assembly have a predetermined relative position relation; the position identifier is used for determining the target offset position information in combination with the predetermined relative position relationship, and the target offset position information is used for indicating the relative position relationship between the reference position and the target position;

wherein the first relative position information is combined with the target offset position information and/or the second relative position information is usable to assist in guiding the orthopaedic surgical tool to move to the target location.
A navigation processing device for guiding an orthopedic operation tool, characterized in that the navigation processing device is in communication connection with a navigation component of a medical navigation device, the medical navigation device comprises the navigation component and a developing and positioning component, and the navigation component is provided with a sensor;

the developing and positioning assembly is provided with a position mark which can be visually displayed in the medical image;

the navigation processing device is used for acquiring real-time position information which is transmitted by the navigation component and measured by the sensor in a state that the sensor is fixed with the orthopedic operation tool, acquiring first relative position information and/or second relative position information based on the real-time position information, and prompting the first relative position information and/or the second relative position information; the first relative position information is relative position information between a real-time position of the sensor and a reference position where the sensor is located in advance, the real-time position is determined by the real-time position information, the reference position is determined by pre-recorded reference position information, the reference position information comprises first reference position information and/or second reference position information, the first reference position information is position information which is obtained by the navigation component in response to a trigger instruction and is measured by the sensor and sent to the navigation processing device, and the second reference position information is preset position information which is obtained by the navigation processing device in response to the trigger instruction; the second relative position information is relative position information between the real-time position and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by an expected insertion position and/or an expected insertion direction of the orthopedic operation tool in a human body;

When the sensor is positioned at the reference position, the sensor and the position mark of the developing and positioning assembly have a predetermined relative position relation; the position identifier is used for determining the target offset position information in combination with the predetermined relative position relationship, and the target offset position information is used for indicating the relative position relationship between the reference position and the target position;

the first relative position information in combination with the target offset position information and/or the second relative position information may be used to assist in guiding the orthopaedic surgical tool to move to the target location.
The apparatus according to any one of claims 1 to 5, wherein:

the position mark is arranged on the body of the developing and positioning assembly, and the body of the developing and positioning assembly is also provided with a mounting part for mounting the navigation assembly.
The apparatus of claim 6, wherein the location indicia comprises an angular scale, at least one of the angular scales being distributed about the mounting portion.
The device of claim 7, wherein a plurality of said angular scales are provided on said body;

The plurality of angle scales comprise reference angle scales and non-reference angle scales arranged on at least one side of the reference angle scales;

the non-reference angle scale comprises a positive angle scale and/or a negative angle scale.
The apparatus of claim 8, wherein the sensor has a predetermined relative positional relationship with the positional identification of the developing position assembly when the sensor is in the reference position, comprising:

when the sensor is at the reference position, the reference angle scale of the developing and positioning assembly is positioned in the appointed direction of the sensor.
The device of claim 8, wherein the mounting portion and the plurality of angular graduations are each disposed on the first surface of the body.
The apparatus of claim 10, wherein the mounting portion comprises a mounting slot, the navigation assembly being at least partially received in the mounting slot.
The apparatus of claim 11, wherein the projection of the mounting groove in a plane parallel to the first surface forms an axisymmetric pattern;

and the symmetry axis of the axisymmetric graph is arranged in line with an extension line of the projection of the reference angle scale in the first surface.
The apparatus of any one of claims 1 to 5, wherein a first contact is provided on the developing position assembly and a second contact is provided on the navigation assembly, the navigation assembly being activated when the first contact is in contact with the second contact.
The apparatus of claim 13, wherein the trigger instruction comprises an activation signal generated when the first contact is in contact with the second contact.
The apparatus of claim 13, wherein the device comprises a plurality of sensors,

and after the navigation component is activated, recording the reference position information of the sensor when the trigger instruction is received.
The apparatus according to any one of claims 1 to 5, wherein:

the reference position information is position information measured by the sensor, which is obtained in response to the trigger instruction.
The apparatus according to any one of claims 1 to 5, wherein:

the reference position information is position information measured by the sensor after the sensor is initialized in response to the trigger instruction.
The apparatus according to any one of claims 1 to 5, wherein:

the first relative position information comprises a first displacement deviation and/or a first angular deviation between the real-time position and the reference position.
The apparatus of claim 18, wherein the first angular offset is: and projecting the appointed direction of the sensor fixed with the orthopedic operation tool and the appointed direction of the sensor when the sensor is positioned at the reference position to the same plane, and forming an included angle between two projections on the plane.
The medical navigation device of claim 18, wherein the first displacement offset is: the distance between the real-time position of the sensor and the reference position in a direction perpendicular to the horizontal plane.
The apparatus according to claim 1, wherein:

the second relative position information includes a second displacement offset and/or a second angular offset between the real-time position and the ideal feed point of the intramedullary nail.
The apparatus according to claim 21, wherein:

the second angular deviation includes: and projecting the appointed direction of the sensor at the real-time position and the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail to the same plane, and forming an included angle between two projections on the plane.
The apparatus according to claim 22, wherein:

The ideal nail feeding direction is an insertion direction provided for a user;

or alternatively

The ideal nail feeding direction is obtained by analyzing a medical image, and the medical image is obtained by shooting when the sensor is positioned at the reference position.
The apparatus according to claim 21, wherein:

the second displacement offset includes: in the direction perpendicular to the horizontal plane, the sensor is located at a distance between the real-time position and the ideal nail feeding position of the ideal nail feeding point of the intramedullary nail.
The apparatus according to claim 24, wherein:

the ideal screw feeding position is determined by a first reference height value and a second reference height value, wherein the first reference height value is a height value of the sensor in the direction perpendicular to the horizontal plane when the insertion end of the orthopedic operation tool is positioned at the first side vertex of the preset insertion area, and the second reference height value is a height value of the sensor in the direction perpendicular to the horizontal plane when the insertion end of the orthopedic operation tool is positioned at the second side vertex of the preset insertion area.
The apparatus according to any one of claims 2 to 5, wherein:

The second relative position information includes a second displacement offset and/or a second angular offset between the real-time position and the target position.
The apparatus according to claim 26, wherein:

the second angular deviation includes: and projecting the appointed direction and the expected inserting direction of the sensor at the real-time position to the same plane, and then forming an included angle between two projections on the plane.
The apparatus according to claim 27, wherein:

the expected insertion direction is an insertion direction provided for a user;

or alternatively

The expected insertion direction is obtained by analyzing a medical image, and the medical image is obtained by shooting when the sensor is positioned at the reference position.
The apparatus of claim 9 or 19 or 22, wherein the specified direction of the sensor is an axial direction of the navigation assembly.
The apparatus of claim 19 or 22 or 27, wherein the same plane is a horizontal plane.
The apparatus according to claim 26, wherein:

the second displacement offset includes: in a direction perpendicular to the horizontal plane, the sensor is located at a distance between the real-time position and the intended insertion position.
The apparatus of claim 31, wherein the device comprises a plurality of sensors,

the height value of the expected insertion position in the direction perpendicular to the horizontal plane is determined by a first reference height value and a second reference height value, wherein the first reference height value is a height value of the sensor in the direction perpendicular to the horizontal plane when the insertion end of the orthopedic operation tool is positioned at a first side vertex of a predetermined insertion area, and the second reference height value is a height value of the sensor in the direction perpendicular to the horizontal plane when the insertion end of the orthopedic operation tool is positioned at a second side vertex of the predetermined insertion area.
A device according to any one of claims 1 to 3, wherein the navigation assembly is further adapted to prompt the pitch angle measured by the sensor;

the pitch angle is as follows: and an included angle between the bottom surface of the navigation component and the horizontal plane.
The apparatus according to claim 4 or 5, wherein: the navigation component is also used for transmitting the pitch angle measured by the sensor to external prompting equipment for prompting;

the pitch angle is as follows: and an included angle between the bottom surface of the navigation component and the horizontal plane.
The apparatus according to any one of claims 1 to 5, wherein the navigation module is further configured to provide error prompt information, where the error prompt information is information generated when a cumulative time period is longer than a preset time period, and/or the error prompt information is information generated when an error obtained by calculation is greater than an error threshold, where the cumulative time period is a time period from when the reference position information is recorded or when the sensor is calibrated last time.
The apparatus according to any one of claims 1 to 5, wherein the means for presenting the first relative position information and/or the second relative position information comprises:

displaying the first relative position information and/or the second relative position information in real time;

and/or

And outputting the voice information of the first relative position information and/or the second relative position information.
The device according to any one of claims 1 to 5, wherein the navigation component is provided with a touch screen, and the trigger instruction is received through the touch screen, and the trigger instruction is used for indicating to record the reference position information.
The device according to any one of claims 1 to 5, wherein the navigation component is provided with an entity key and/or a voice acquisition component, and the trigger instruction is received through the entity key and/or the voice acquisition component, and the trigger instruction is used for indicating to record the reference position information.
The device according to any one of claims 1 to 5, wherein,

the developing and positioning assembly is assembled and connected with the navigation assembly in a magnetic attraction mode.
The device of any one of claims 1 to 5, wherein the navigation assembly is removably secured to the orthopaedic surgical tool.
The apparatus according to claim 40, wherein: the navigation component is detachably fixed with the orthopedic operation tool in a magnetic attraction and/or clamping mode.
The device of any one of claims 1 to 5, wherein the orthopaedic surgical tool is a guide pin, a holder or an electric drill.
The apparatus according to any one of claims 1 to 5, wherein: the sensor is an inertial sensor.
The device of any one of claims 1 to 5, wherein the number of sensors is 1.
A navigation method for a medical navigation device for intramedullary nail insertion point navigation, the medical navigation device comprising a navigation component and a visualization positioning component, the navigation component being provided with a sensor, the visualization positioning component being provided with a position marker, the position marker being visually presentable in a medical image, the method comprising:

when a trigger instruction is received, responding to the trigger instruction to record reference position information of a sensor of the navigation component when the sensor is at a reference position, wherein the sensor has a predetermined relative position relation with a position mark of the development positioning component when the sensor is at the reference position, the position mark is used for determining target offset position information in combination with the predetermined relative position relation, and the target offset position information is used for indicating the relative position relation between the reference position and an ideal intramedullary nail feeding point;

Acquiring real-time position information of the sensor in a state that the sensor is fixed with an orthopedic operation tool, and acquiring first relative position information and/or second relative position information based on the real-time position information, wherein the first relative position information is the relative position information between the real-time position of the sensor and the reference position, and the real-time position is determined by the real-time position information; the second relative position information is the relative position information between the real-time position and an ideal nail feeding point of the intramedullary nail, and is determined by the real-time position information and the target offset position information;

prompting the first relative position information and/or the second relative position information, wherein the first relative position information is combined with the target offset position information, and/or the second relative position information can be used for assisting in guiding the orthopaedic surgical tool to move to the ideal intramedullary nail feeding point.
A navigation method for a medical navigation device for guiding an orthopaedic surgical tool, the medical navigation device comprising a navigation component and a visualization positioning component, the navigation component being provided with a sensor, the visualization positioning component being provided with a location identifier, the location identifier being visually presentable in a medical image, the method comprising:

When a trigger instruction is received, responding to the trigger instruction to record reference position information of a sensor of the navigation component when the sensor is at a reference position, wherein the sensor has a predetermined relative position relation with a position mark of the development positioning component when the sensor is at the reference position, the position mark is used for determining target offset position information in combination with the predetermined relative position relation, and the target offset position information is used for indicating the relative position relation between the reference position and the target position;

acquiring real-time position information of the sensor in a state that the sensor is fixed with an orthopedic operation tool, and acquiring first relative position information and/or second relative position information based on the real-time position information, wherein the first relative position information is the relative position information between the real-time position of the sensor and the reference position, and the real-time position is determined by the real-time position information; the second relative position information is relative position information between the real-time position and a target position, the second relative position information is determined by the real-time position information and the target offset position information, and the target position is determined by an expected insertion position and/or an expected insertion direction of the orthopedic operation tool in a human body;

And prompting the first relative position information and/or the second relative position information in real time, wherein the first relative position information is combined with the target offset position information, and/or the second relative position information can be used for assisting in guiding the orthopedic operation tool to move to the target position.
A navigation method for a medical navigation device for guiding an orthopaedic surgical tool, the medical navigation device comprising a navigation component and a visualization positioning component, the navigation component being provided with a sensor, the visualization positioning component being provided with a location identifier, the location identifier being visually presentable in a medical image, the method comprising:

acquiring real-time position information measured by a sensor of the navigation assembly fixed with the orthopedic operation tool;

transmitting the real-time position information to an external processing device;

receiving first relative position information and/or second relative position information fed back by the external processing equipment, and prompting the first relative position information and/or the second relative position information; the first relative position information is relative position information between a real-time position of the sensor and a reference position where the sensor is located in advance, the real-time position is determined by the real-time position information, the reference position is determined by pre-recorded reference position information, the reference position information comprises first reference position information and/or second reference position information, the first reference position information is position information which is obtained by the navigation component in response to a trigger instruction and is measured by the sensor and sent to the external processing device, and the second reference position information is preset position information obtained by the external processing device in response to the trigger instruction; the second relative position information is the relative position information between the real-time position of the sensor and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by the expected insertion position and/or the expected insertion direction of the orthopedic operation tool in the human body;

When the sensor is positioned at the reference position, the sensor and a position mark of the developing and positioning assembly have a predetermined relative position relation, the position mark is used for determining target offset position information in combination with the predetermined relative position relation, and the target offset position information is used for indicating the relative position relation between the reference position and the target position;

the first relative position information in combination with the target offset position information and/or the second relative position information may be used to assist in guiding the orthopaedic surgical tool to move to the target location.
A navigation method for a medical navigation device for guiding an orthopaedic surgical tool, the medical navigation device comprising a navigation component and a visualization positioning component, the navigation component being provided with a sensor, the visualization positioning component being provided with a location identifier, the location identifier being visually presentable in a medical image, the method comprising:

when a trigger instruction is received, recording reference position information of a sensor of the navigation component when the sensor is at a reference position in response to the trigger instruction;

Acquiring real-time position information of the sensor in a state that the sensor is fixed with an orthopedic operation tool, and acquiring first relative position information and/or second relative position information based on the real-time position information, wherein the first relative position information is the relative position information between the real-time position of the sensor and the reference position, and the real-time position is determined by the real-time position information; the second relative position information is relative position information between the real-time position and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by an expected insertion position and/or an expected insertion direction of the orthopedic operation tool in a human body;

transmitting the first relative position information and/or the second relative position information to an external prompting device, and prompting the first relative position information and/or the second relative position information by the external prompting device;

when the sensor is positioned at the reference position, the sensor and a position mark of the developing positioning assembly have a predetermined relative position relation, the position mark is used for determining target offset position information in combination with the predetermined relative position relation, and the target offset position information is used for indicating the relative position relation between the reference position and the target position; the first relative position information in combination with the target offset position information and/or the second relative position information may be used to assist in guiding the orthopaedic surgical tool to move to the target location.
A navigation method for a medical navigation device for guiding an orthopaedic surgical tool, the medical navigation device comprising a navigation component and a visualization positioning component, the navigation component being provided with a sensor, the visualization positioning component being provided with a location identifier, the location identifier being capable of being visualized in a medical image, the navigation component of the medical navigation device being in communication with a navigation processing device, the method being performed by the navigation processing device, the method comprising:

acquiring real-time position information which is transmitted by the navigation component and measured by the sensor in a state that the sensor is fixed with an orthopedic operation tool;

acquiring first relative position information and/or second relative position information based on the real-time position information, wherein the first relative position information is the relative position information between the real-time position of the sensor and a reference position where the sensor is located in advance, the real-time position is determined by the real-time position information, the reference position is determined by pre-recorded reference position information, the reference position information comprises first reference position information and/or second reference position information, the first reference position information is the position information measured by the sensor, which is acquired by the navigation component in response to a trigger instruction and sent to the navigation processing device, and the second reference position information is preset position information acquired by the navigation processing device in response to the trigger instruction; the second relative position information is relative position information between the real-time position and a target position, the second relative position information is determined by the real-time position information and target offset position information, and the target position is determined by an expected insertion position and/or an expected insertion direction of the orthopedic operation tool in a human body;

Prompting the first relative position information and/or the second relative position information;

when the sensor is positioned at the reference position, the sensor and the position mark of the developing and positioning assembly have a predetermined relative position relation; the position identifier is used for determining the target offset position information in combination with the predetermined relative position relationship, and the target offset position information is used for indicating the relative position relationship between the reference position and the target position;

the first relative position information in combination with the target offset position information and/or the second relative position information may be used to assist in guiding the orthopaedic surgical tool to move to the target location.
The method of any one of claims 45 to 49, further comprising:

the navigation assembly is activated when a first contact on the navigation assembly is in contact with a second contact on the developer positioning assembly.
The method of claim 50, wherein the trigger instruction includes an activation signal generated when the first contact is in contact with the second contact.
The method of claim 50, wherein upon receiving the trigger instruction after the navigation assembly is activated, recording reference position information for the sensor.
The method of any one of claims 45 to 49, wherein:

the reference position information is position information measured by the sensor, which is obtained in response to the trigger instruction.
The method of any one of claims 45 to 49, wherein:

the reference position information is position information measured by the sensor after the sensor is initialized in response to the trigger instruction.
The method of any one of claims 45 to 49, wherein:

the first relative position information comprises a first displacement deviation and/or a first angular deviation between the real-time position and the reference position.
The method of claim 55, wherein the first angular offset is: and projecting the appointed direction of the sensor fixed with the orthopedic operation tool and the appointed direction of the sensor when the sensor is positioned at the reference position to the same plane, and forming an included angle between two projections on the plane.
The method of claim 55, wherein the first displacement bias is: the distance between the real-time position of the sensor and the reference position in a direction perpendicular to the horizontal plane.
The method according to claim 45, wherein:

the second relative position information includes a second displacement offset and/or a second angular offset between the real-time position and the ideal feed point of the intramedullary nail.
The method according to claim 58, wherein:

the second angular deviation includes: and projecting the appointed direction of the sensor at the real-time position and the ideal nail feeding direction of the ideal nail feeding point of the intramedullary nail to the same plane, and forming an included angle between two projections on the plane.
The method of claim 59, wherein:

the ideal nail feeding direction is an insertion direction provided for a user;

or alternatively

The ideal nail feeding direction is obtained by analyzing a medical image, and the medical image is obtained by shooting when the sensor is positioned at the reference position.
The method according to claim 58, wherein:

the second displacement offset includes: in the direction perpendicular to the horizontal plane, the sensor is located at a distance between the real-time position and the ideal nail feeding position of the ideal nail feeding point of the intramedullary nail.
The method according to claim 61, wherein:

The ideal screw feeding position is determined by a first reference height value and a second reference height value, wherein the first reference height value is a height value of the sensor in the direction perpendicular to the horizontal plane when the insertion end of the orthopedic operation tool is positioned at the first side vertex of the preset insertion area, and the second reference height value is a height value of the sensor in the direction perpendicular to the horizontal plane when the insertion end of the orthopedic operation tool is positioned at the second side vertex of the preset insertion area.
The method of any one of claims 46 to 49, wherein:

the second relative position information includes a second displacement offset and/or a second angular offset between the real-time position and the target position.
The method as set forth in claim 63, wherein:

the second angular deviation includes: and projecting the appointed direction and the expected inserting direction of the sensor at the real-time position to the same plane, and then forming an included angle between two projections on the plane.
The method as set forth in claim 64, wherein:

the expected insertion direction is an insertion direction provided for a user;

Or alternatively

The expected insertion direction is obtained by analyzing a medical image, and the medical image is obtained by shooting when the sensor is positioned at the reference position.
The method of claim 56 or 59 or 64, wherein the specified direction of the sensor is an axial direction of the navigation assembly.
The method of claim 56 or 59 or 64, wherein the same plane is a horizontal plane.
The method according to claim 67, wherein:

the second displacement offset includes: in a direction perpendicular to the horizontal plane, the sensor is located at a distance between the real-time position and the intended insertion position.
The method of claim 68, wherein:

the height value of the expected insertion position in the direction perpendicular to the horizontal plane is determined by a first reference height value and a second reference height value, wherein the first reference height value is a height value of the sensor in the direction perpendicular to the horizontal plane when the insertion end of the orthopedic operation tool is positioned at a first side vertex of a predetermined insertion area, and the second reference height value is a height value of the sensor in the direction perpendicular to the horizontal plane when the insertion end of the orthopedic operation tool is positioned at a second side vertex of the predetermined insertion area.
The method of any one of claims 45 to 47, further comprising:

acquiring a pitch angle between the bottom surface of the navigation assembly and a horizontal plane, which is measured by a sensor of the navigation assembly;

and prompting the pitch angle.
The method of claim 48 or 50, further comprising:

acquiring a pitch angle between the bottom surface of the navigation assembly and a horizontal plane, which is measured by a sensor of the navigation assembly;

and transmitting the pitch angle to external prompt equipment for prompt.
The method of any one of claims 45 to 49, further comprising:

providing error prompt information, wherein the error prompt information is information generated when the accumulated time length is longer than a preset time length, and/or the error prompt information is information generated when the calculated error is greater than an error threshold value, and the accumulated time length is time length from when the reference position information is recorded or when the sensor is calibrated last time.
An electronic device comprising a processor and a memory, the memory storing a computer program, characterized in that the computer program, when executed by the processor, causes the processor to implement the steps of the method of any one of claims 45 to 72.
A computer readable storage medium having stored thereon a computer program, which when executed by a processor performs the steps of the method of any of claims 45 to 72.
A computer program product comprising a computer program, characterized in that the computer program, when executed by a processor, implements the steps of the method of any of claims 45 to 72.
A medical navigation system, the medical navigation system comprising: an orthopaedic surgical tool, and an apparatus as claimed in any one of claims 1 to 44.