A fully automatic biopsy needle and a biopsy system based on electromagnetic positioning

Abstract

The present application provides a fully automatic biopsy needle and a biopsy system based on electromagnetic positioning, which belongs to the field of medical device technology, specifically, including: a housing, a firing assembly, a trigger assembly, a biopsy needle assembly and a first electromagnetic navigation sensor. The biopsy needle assembly includes a needle core and a needle tube, the needle core includes a needle body and a needle tip, the needle body has a sensor assembly channel, and the first electromagnetic navigation sensor extends to a position close to the needle tip in the sensor assembly channel. Under the data compensation of the external device, when the biopsy needle is inserted into the human body, the operator can use the navigation device to identify the spatial position of the first electromagnetic navigation sensor in the human body, and then use the first electromagnetic navigation sensor and the size relationship between the needle tip and the sampling slot in the biopsy needle assembly to accurately calculate the spatial position of the needle tip and the sampling slot in the human body, so as to determine the positional relationship between the needle tip and the sampling slot of the biopsy needle assembly and the target sampling position, and accurately sample the target position.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a fully automatic biopsy needle and a biopsy system based on electromagnetic positioning. Background Art

[0002] The fully automatic biopsy needle is an advanced medical device used to obtain tissue samples for pathological testing. Compared with the traditional manual biopsy method, the fully automatic biopsy needle realizes automation in emission and sampling, which improves the efficiency and accuracy of biopsy.

[0003] At present, during clinical biopsy, fully automatic biopsy needles are usually used in combination with image navigation technology, including X-ray fluoroscopy, ultrasound, CT and MR. In the preoperative preparation stage, the surgeon first uses various imaging technologies (such as ultrasound, CT or MRI) to image the patient to obtain detailed information about the target lesion, including its location, size, shape and other characteristics. Then, a detailed sampling plan is formulated based on the imaging data to determine the puncture point, insertion path, angle and depth of the biopsy needle. During the operation, the fully automatic biopsy needle is operated according to the above information for sampling.

[0004] However, during the actual implementation of the operation, the surgeon can only determine the puncture point on the patient's body surface, but the specific position of the biopsy needle after entering the human body and its distance from the target sampling position cannot be accurately grasped. Only its approximate position can be judged for sampling, which may affect the sampling results. Summary of the invention

[0005] The purpose of the present application is to provide a fully automatic biopsy needle, which aims to solve the problem in the related art that the specific position of the biopsy needle after entering the human body and its distance from the target sampling position cannot be accurately grasped, which may affect the sampling results.

[0006] Additional aspects and advantages of the present application will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the present application.

[0007] According to a first aspect of the present application, a fully automatic biopsy needle is provided, comprising:

[0008] a housing, a firing assembly, a trigger assembly, a biopsy needle assembly, and a first electromagnetic navigation sensor;

[0009] The firing assembly, the trigger assembly, the biopsy needle assembly and the first electromagnetic navigation sensor are assembled on the housing;

[0010] The firing assembly is connected to the biopsy needle assembly, and the firing assembly has an energy storage state in which the biopsy needle assembly is retracted toward the proximal end of the housing, and a firing state in which the biopsy needle assembly is extended toward the distal end of the housing under the triggering of the trigger assembly. During the switching process from the energy storage state to the firing state, the biopsy needle assembly completes biopsy sampling;

[0011] The trigger assembly is used to trigger the firing assembly to switch the firing assembly from the energy storage state to the firing state;

[0012] The biopsy needle assembly comprises a needle core and a needle tube which are sleeved together, the needle core comprises a needle tip arranged at a distal end and a needle body connected to a proximal end of the needle tip and extending toward the proximal end of the housing, a hollow sensor assembly channel is formed inside the needle body, and the sensor assembly channel extends along the length direction of the needle body;

[0013] The first electromagnetic navigation sensor is a slender structure. When the firing assembly is in the energy storage state, the first electromagnetic navigation sensor extends to the target position at the far end of the sensor assembly channel. When the firing assembly drives the biopsy needle assembly to switch from the energy storage state to the firing state, the first electromagnetic navigation sensor is fixed.

[0014] In an exemplary embodiment of the present application, a connecting through hole is opened at the proximal end of the shell, and the connecting through hole is communicated with the sensor assembly channel. The connecting through hole is used to install a first connecting piece. The distal end of the first electromagnetic navigation sensor passes through the first connecting piece and extends into the target position of the sensor assembly channel. The proximal end of the first electromagnetic navigation sensor is suitable for connecting to a navigation device, and the first electromagnetic navigation sensor and the first connecting piece are relatively fixedly arranged.

[0015] In an exemplary embodiment of the present application, the connection between the first connecting member and the connecting through hole is configured such that the first connecting member can rotate relative to the connecting through hole under an external force torque.

[0016] In an exemplary embodiment of the present application, a connecting cap is provided at the distal end of the first connecting member, and the connecting cap is inserted into the connecting through hole. An annular protrusion or an annular groove is provided on the side wall of the connecting cap, and an annular groove or annular protrusion is provided on the inner wall of the connecting through hole. The connecting cap is rotatably connected to the connecting through hole through the cooperation of the annular protrusion and the annular groove.

[0017] In an exemplary embodiment of the present application, the proximal end of the first electromagnetic navigation sensor is sleeved with a second connecting piece, the distal end of the first electromagnetic navigation sensor passes through the distal end of the second connecting piece, the first electromagnetic navigation sensor and the second connecting piece are fixedly arranged, and the distal end of the second connecting piece is detachably connected to the proximal end of the first connecting piece; when the distal end of the second connecting piece is connected to the proximal end of the first connecting piece in place, the distal end of the first electromagnetic navigation sensor extends into the target position of the sensor assembly channel.

[0018] In an exemplary embodiment of the present application, the first connecting member is a first connecting pipe, and the second connecting member is a second connecting pipe.

[0019] In an exemplary embodiment of the present application, a fixed protective tube is arranged inside the proximal end of the shell, and the centers of the fixed protective tube, the connecting through hole and the sensor assembly channel are aligned, and the first electromagnetic navigation sensor passes through the connecting through hole and the fixed protective tube and extends into the sensor assembly channel.

[0020] In an exemplary embodiment of the present application, the proximal end of the needle core extends into the interior of the fixed protective tube, and the length of the needle core extending into the fixed protective tube is set so that the needle core will not fall out from the distal port of the fixed protective tube when the needle core is fired with the firing assembly, and will not extend from the proximal port of the fixed protective tube when the needle core is switched to the energy storage state with the firing assembly.

[0021] In an exemplary embodiment of the present application, the target position is the distal end of the sensor assembly channel.

[0022] In an exemplary embodiment of the present application, the needle tip and the needle body are provided separately, and the proximal end of the needle tip and the distal end of the needle body are connected by bonding or welding.

[0023] In an exemplary embodiment of the present application, the firing assembly includes a first sub-firing assembly arranged at the proximal end and a second sub-firing assembly arranged at the distal end, the shell has a first cavity arranged at the proximal end and a second cavity arranged at the distal end, the first sub-firing assembly is installed in the first cavity, the second sub-firing assembly is installed in the second cavity, the needle core is connected to the first sub-firing assembly, the needle tube is connected to the second sub-firing assembly, the first sub-firing assembly is triggered by the trigger assembly to switch from the energy storage state to the firing state, and at the same time drives the needle core to pop out in the distal direction, and when the first sub-firing assembly switches to the firing state, it triggers the second sub-firing assembly to switch from the energy storage state to the firing state, and at the same time drives the needle tube to pop out in the distal direction.

[0024] In an exemplary embodiment of the present application, the first sub-firing assembly includes a first slider and a first elastic member, and the second sub-firing assembly includes a second slider and a second elastic member;

[0025] The needle core is fixedly connected to the first slider, and the first slider is slidably installed in the first cavity. The first slider has an energy storage state in the first cavity for compressing the first elastic member to shrink the needle core, and the first slider also has a firing state in the first cavity for driving the needle core to pop out;

[0026] The needle tube is fixedly connected to the second slider, and the second slider is slidably installed in the second cavity. The second slider has an energy storage state in the second cavity for compressing the second elastic member to shrink the needle tube, and the second slider also has a firing state in the second cavity for driving the needle tube to pop out.

[0027] In an exemplary embodiment of the present application, the trigger assembly includes a trigger key and a trigger connecting rod, the trigger key is connected to the trigger connecting rod, and the trigger key and the trigger connecting rod are both slidably mounted in the housing, and the trigger key and the trigger connecting rod switch between the initial position and the trigger position during the sliding process;

[0028] When the trigger link slides to the trigger position, it is used to push the first elastic member out of the first slot, so that the first slider switches from the energy storage state to the firing state.

[0029] In an exemplary embodiment of the present application, the trigger key includes a side trigger key and a rear trigger key, both of which are fixedly connected to the trigger link, the side trigger key is arranged on the side of the shell, and the rear trigger key is arranged at the proximal end of the shell.

[0030] The second aspect of the present application provides a biopsy system based on electromagnetic positioning, comprising the fully automatic biopsy needle according to any one of the above-mentioned first aspects, a second electromagnetic navigation sensor and a navigation device;

[0031] The second electromagnetic navigation sensor is fixedly connected to the ultrasonic probe;

[0032] The navigation device is configured to extract electromagnetic signals received by the first electromagnetic navigation sensor and the second electromagnetic navigation sensor, and use the electromagnetic signals to determine the spatial position relationship between the full-automatic biopsy needle and the ultrasound probe.

[0033] The exemplary embodiments of the present application may have some or all of the following beneficial effects:

[0034] The fully automatic biopsy needle provided in the example embodiment of the present application includes a shell, a firing assembly, a trigger assembly, a biopsy needle assembly, and a first electromagnetic navigation sensor. The shell forms a handle for the operator to hold and operate. The firing assembly, the trigger assembly, the biopsy needle assembly, and the first electromagnetic navigation sensor are all assembled in the handle formed by the shell, wherein the firing assembly is connected to the biopsy needle assembly, and the firing assembly has an energy storage state for driving the biopsy needle assembly to retract inward in the proximal direction of the shell, and the firing assembly also has a firing state for driving the biopsy needle assembly to extend outward in the distal direction of the shell under the triggering of the trigger assembly, and the firing assembly drives the biopsy needle assembly in the energy storage state During the switching process from the state to the firing state, the biopsy needle assembly completes the biopsy sampling; the biopsy needle assembly includes a needle core and a needle tube that are sleeved together, the needle core includes a needle tip arranged at the distal end and a needle body connected to the proximal end of the needle tip and extending toward the proximal end of the shell, a hollow sensor assembly channel is formed inside the needle body, and the sensor assembly channel extends along the length direction of the needle body; the first electromagnetic navigation sensor is a slender structure, and when the firing assembly is in the energy storage state, the first electromagnetic navigation sensor extends to the target position at the distal end of the sensor assembly channel, and when the firing assembly drives the biopsy needle assembly to switch from the energy storage state to the firing state, the first electromagnetic navigation sensor is fixed.

[0035] On the one hand, through the cooperation of the trigger assembly, the firing assembly and the biopsy needle assembly, the automatic emission and sampling of the fully automatic biopsy needle are realized, which improves the efficiency and accuracy compared with the manual biopsy needle emission and sampling;

[0036] On the other hand, the fully automatic biopsy needle is combined with the first electromagnetic navigation sensor, and a hollow sensor assembly channel is formed inside the needle core of the biopsy needle assembly, so that during the biopsy operation, the slender first electromagnetic navigation sensor can be extended from the proximal opening of the needle body to the distal target position of the needle body. In this way, when the biopsy needle is inserted into the human body, the operator can use the navigation device to identify the spatial position (position and posture) of the first electromagnetic navigation sensor in the human body, and then use the size relationship between the first electromagnetic navigation sensor and the needle tip and sampling slot in the biopsy needle assembly to accurately calculate the spatial position (position and posture) of the needle tip and sampling slot in the human body, so as to determine the positional relationship between the needle tip and sampling slot of the biopsy needle assembly and the target sampling position;

[0037] On the other hand, since the needle core has a certain firing distance when firing, if the first electromagnetic navigation sensor is fixed inside the needle core and pops out in the distal direction with the needle core when firing, a fixing structure for fixing the first electromagnetic navigation sensor needs to be designed inside the needle core during production, which is difficult to achieve in a narrow sensor assembly channel. In addition, when the biopsy needle needs to take a second sample or multiple samples, the needle core needs to return to the energy storage state with the firing assembly. If the first electromagnetic navigation sensor is fixed inside the needle core, it will shrink in the proximal direction with the needle core. The slender first electromagnetic navigation sensor will be squeezed or bent in the sensor assembly channel, which is easy to cause damage to the first electromagnetic navigation sensor and is not conducive to the service life of the first electromagnetic navigation sensor. If the fixing structure is not firmly fixed, it will also cause the relative position of the first electromagnetic navigation sensor and the needle core to change, resulting in inaccurate spatial positioning of the needle tip and the sampling slot by the navigation device during the second (or multiple) sampling, thereby causing the failure of the second (or multiple) sampling. Therefore, in order to facilitate the production of the needle core and the assembly of the first electromagnetic navigation sensor, and to avoid the failure of secondary (or multiple) sampling caused by the change in the relative position of the first electromagnetic navigation sensor and the needle core during use, in the fully automatic biopsy needle provided in the example embodiment of the present application, when the first electromagnetic navigation sensor is assembled to the sensor assembly channel of the needle body, the two have no fixed relationship, and the interior of the sensor assembly channel does not need to be designed with a fixing structure for fixing the first electromagnetic navigation sensor. When in actual use, the biopsy needle assembly is first adjusted to the energy storage state, and then the first electromagnetic navigation sensor is extended along the sensor assembly channel of the needle body to the sensor. After the assembly of the first electromagnetic navigation sensor, the target position at the far end of the assembly channel is completed, and finally the biopsy needle assembly in the energy storage state is inserted into the human body for firing sampling. The spatial position (position and posture) of the needle tip (and its sampling slot) in the biopsy needle assembly is determined by the first electromagnetic navigation sensor. When the firing assembly drives the biopsy needle assembly to switch from the energy storage state to the firing state, the first electromagnetic navigation sensor is fixed, and the specific spatial position of the needle tip (and its sampling slot) after firing can be calculated by the spatial position of the first electromagnetic navigation sensor and the target position of the sensor assembly channel and the size relationship between the needle tip (and its sampling slot). This setting can not only realize the positioning of the spatial position of the needle tip (and its sampling slot) during the operation, but also has a simple structure, is easy to produce, and the first electromagnetic navigation sensor is not easy to be damaged.

[0038] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] The drawings herein are incorporated into the specification and constitute a part of the specification, illustrate embodiments consistent with the present application, and together with the specification are used to explain the principles of the present application. Obviously, the drawings described below are only some embodiments of the present application, and for ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0040] Figure 1 A schematic diagram of the structure of a fully automatic biopsy needle in Example 1 of the present application is shown;

[0041] Figure 2 A partial exploded view of a fully automatic biopsy needle in Example 1 of the present application is shown;

[0042] Figure 3 A schematic diagram of the exploded view of the needle core in the biopsy needle assembly in Example 1 of the present application is shown;

[0043] Figure 4 A cross-sectional view of the firing assembly in Embodiment 1 of the present application when in an energy storage state is shown;

[0044] Figure 5 Shows Figure 4 The enlarged schematic diagram at A in the middle;

[0045] Figure 6 An exploded view of a fully automatic biopsy needle in Example 1 of the present application is shown;

[0046] Figure 7 A schematic diagram showing the connection between the first connecting tube, the connecting cap and the electromagnetic navigation sensor in an embodiment of the present application is shown;

[0047] Figure 8 Shows Figure 7 The enlarged schematic diagram of point B in the middle;

[0048] Fig. 9 A schematic diagram showing the structure of the firing assembly in the first embodiment of the present application when it is in a firing state;

[0049] Fig.10 A cross-sectional view of the firing assembly in embodiment 1 of the present application when in a firing state is shown;

[0050] Fig.11 A schematic structural diagram of the firing assembly in Example 1 of the present application is shown.

[0051] Description of reference numerals:

[0052] 1. Biopsy needle assembly; 101. Needle core; 1011. Needle body; 1012. Needle tip; 1013. Sensor assembly channel; 1014. Sampling slot; 102. Needle tube;

[0053] 2. housing; 3. rear trigger key; 4. side trigger key; 5. trigger assembly; 51. third slider; 511. second inclined surface; 52. elastic wing;

[0054] 6. firing assembly; 61. first sub-firing assembly; 611. first slider; 6111. first elastic block; 6112. first inclined surface; 612. first elastic member; 62. second sub-firing assembly; 621. second slider; 6211. second elastic block; 6212. third inclined surface; 622. second elastic member;

[0055] 7. First inner shell; 8. Second inner shell; 9. Second push button; 10. First push button; 11. First electromagnetic navigation sensor; 12. Connecting through hole; 13. Connecting cap; 14. Fixed protection tube; 15. Trigger connecting rod; 16. First card slot; 17. Second card slot; 18. Fourth inclined surface; 22. First connecting tube; 23. Annular protrusion. DETAILED DESCRIPTION

[0056] Example embodiments will now be described more fully with reference to the accompanying drawings. However, the example embodiments can be implemented in a variety of forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that the present application will be comprehensive and complete and fully convey the concepts of the example embodiments to those skilled in the art. The same reference numerals in the figures represent the same or similar structures, and thus their detailed descriptions will be omitted. In addition, the drawings are only schematic illustrations of the present application and are not necessarily drawn to scale.

[0057] Although relative terms such as "upper" and "lower" are used in this specification to describe the relative relationship of one component of the illustration to another component, these terms are used in this specification only for convenience, such as according to the direction of the examples in the drawings. It is understood that if the device of the illustration is turned upside down, the component described as "upper" will become the component "lower". When a structure is "on" other structures, it may mean that the structure is formed integrally on the other structure, or that the structure is "directly" disposed on the other structure, or that the structure is "indirectly" disposed on the other structure through another structure.

[0058] The terms "a", "an", "the" and "at least one" are used to indicate the presence of one or more elements / components / etc.; the terms "including" and "having" are used to express an open-ended inclusive meaning and mean that additional elements / components / etc. may exist in addition to the listed elements / components / etc.; the terms "first" and "second" are used merely as labels and are not intended to limit the quantity of their objects.

[0059] The term "proximal" refers to the end closer to the operator and "distal" refers to the end farther from the operator. Example 1

[0060] This embodiment provides a specific implementation of a fully automatic biopsy needle, such as Figure 1 , Figure 2 and Figure 3 As shown, it includes a shell, a firing assembly 6, a trigger assembly 5, a biopsy needle assembly 1, and a first electromagnetic navigation sensor 11. The shell forms a handle for the operator to hold and operate. The firing assembly 6, the trigger assembly 5, the biopsy needle assembly 1 and the first electromagnetic navigation sensor 11 are all assembled in the handle formed by the shell, wherein the firing assembly 6 is connected to the biopsy needle assembly 1, and the firing assembly 6 has an energy storage state for driving the biopsy needle assembly 1 to retract toward the proximal direction of the shell, and the firing assembly 6 also has a firing state for driving the biopsy needle assembly 1 to extend toward the distal direction of the shell under the triggering of the trigger assembly 5. The firing assembly 6 drives the biopsy needle assembly 1 to switch from the energy storage state to the firing state, and the biopsy needle assembly 1 completes the biopsy sampling; the biopsy needle assembly 1 includes a needle core 101 and a needle tube 102, and the needle core 101 includes a needle body 1011 and a needle tip 1 012, the needle body 1011 is internally formed with a sensor assembly channel 1013 extending along the length direction of the needle body 1011, and the first electromagnetic navigation sensor 11 can be inserted into the sensor assembly channel 1013 through the proximal opening of the needle body 1011, so that during the biopsy, the slender first electromagnetic navigation sensor 11 can be inserted from the proximal opening of the needle body 1011 to the distal target position of the needle body 1011, close to the needle tip 1012, so that when the biopsy needle is inserted into the human body, the operator can use the navigation device to identify the spatial position of the first electromagnetic navigation sensor 11 in the human body, and then use the size relationship between the first electromagnetic navigation sensor 11 and the needle tip 1012 and the sampling slot 1014 in the biopsy needle assembly 1 to accurately calculate the spatial position of the needle tip 1012 and the sampling slot 1014 in the human body. It should be noted that in this article, the spatial position includes position and posture.

[0061] In this embodiment, on the one hand, through the cooperation of the trigger assembly 5, the firing assembly 6 and the biopsy needle assembly 1, the automatic emission and sampling of the fully automatic biopsy needle are realized, which improves the efficiency and accuracy compared with the manual biopsy needle emission and sampling;

[0062] On the other hand, the fully automatic biopsy needle is combined with the first electromagnetic navigation sensor 11. By forming a hollow sensor assembly channel 1013 inside the needle core 101 of the biopsy needle assembly 1, during the biopsy, the slender first electromagnetic navigation sensor 11 can be extended from the proximal opening of the needle body 1011 to the distal target position of the needle body 1011. In this way, when the biopsy needle is inserted into the human body, the operator can use the navigation device to identify the spatial position (position and posture) of the first electromagnetic navigation sensor 11 in the human body, and then use the size relationship between the first electromagnetic navigation sensor 11 and the needle tip 1012 and the sampling slot 1014 in the biopsy needle assembly 1 to accurately calculate the spatial position (position and posture) of the needle tip 1012 and the sampling slot 1014 in the human body, so as to determine the positional relationship between the needle tip 1012 and the sampling slot 1014 of the biopsy needle assembly 1 and the target sampling position;

[0063] On the other hand, since the needle core 101 has a certain firing distance when fired, if the first electromagnetic navigation sensor 11 is fixed inside the needle core 101 and pops out in the distal direction together with the needle core 101 when fired, then a fixing structure for fixing the first electromagnetic navigation sensor 11 needs to be designed inside the needle core 101 during production, which is difficult to achieve in the narrow sensor assembly channel 1013. In addition, when the biopsy needle needs to take a second sample or multiple samples, the needle core 101 needs to return to the energy storage state along with the firing assembly 6. If the first electromagnetic navigation sensor 11 is fixed inside the needle core 101, it will retract in the proximal direction along with the needle core 101. The slender first electromagnetic navigation sensor 11 will be squeezed or bent in the sensor assembly channel 1013, which may easily cause damage to the first electromagnetic navigation sensor 11, which is not conducive to the service life of the first electromagnetic navigation sensor 11. Moreover, if the fixing structure is not firmly fixed, the relative position of the first electromagnetic navigation sensor 11 and the needle core 101 will change, resulting in inaccurate spatial positioning of the needle tip 1012 and the sampling slot 1014 by the navigation device during the second (or multiple) sampling, thereby causing the failure of the second (or multiple) sampling. Therefore, in order to facilitate the production of the needle core 101 and the assembly of the first electromagnetic navigation sensor 11, and to avoid the change of the relative position of the first electromagnetic navigation sensor 11 and the needle core 101 during use, which may cause secondary (or multiple) sampling failures, in the fully automatic biopsy needle provided in the example embodiment of the present application, when the first electromagnetic navigation sensor 11 is assembled to the sensor assembly channel 1013 of the needle body 1011, there is no fixed relationship between the two, and there is no need to design a fixing structure inside the sensor assembly channel 1013 for fixing the first electromagnetic navigation sensor 11. When in actual use, the biopsy needle assembly 1 is first adjusted to the energy storage state, and then the first electromagnetic navigation sensor 11 is adjusted to the energy storage state. 11 extends along the sensor assembly channel 1013 of the needle core 101 to the target position at the far end of the sensor assembly channel 1013. After the assembly of the first electromagnetic navigation sensor 11 is completed, the biopsy needle assembly 1 in the energy storage state is finally inserted into the human body for firing sampling. When the firing assembly 6 drives the biopsy needle assembly 1 to switch from the energy storage state to the firing state, the first electromagnetic navigation sensor 11 is fixed. The specific spatial position of the needle tip 1012 and the sampling slot 1014 after firing can be calculated based on the spatial position of the first electromagnetic navigation sensor 11 and the target position of the sensor assembly channel and the size relationship between the needle tip 1012 and the sampling slot 1014. This setting can not only realize the positioning of the spatial position of the needle tip 1012 and the sampling slot 1014 during the operation, but also has a simple structure, is easy to produce, and the first electromagnetic navigation sensor is not easy to be damaged.

[0064] In order to accurately and conveniently assemble the first electromagnetic navigation sensor 11, in this embodiment, Figure 7 and Figure 8As shown, a connecting through hole 12 is opened at the proximal end of the shell, and the connecting through hole 12 is connected to the sensor assembly channel 1013. The connecting through hole 12 is used to install a first connecting piece. A channel suitable for the slender first electromagnetic navigation sensor 11 to pass through is formed inside the first connecting piece. The first connecting piece is arranged to pass through the distal end of the first electromagnetic navigation sensor and extend into a target position at the distal end of the sensor assembly channel. The proximal end of the first electromagnetic navigation sensor 11 is suitable for connecting to a navigation device, and the first electromagnetic navigation sensor 11 and the first connecting piece are relatively fixedly arranged.

[0065] During assembly, the operator can hold the first electromagnetic navigation sensor 11, align its distal end with the channel of the first connecting piece, insert the proximal end of the first electromagnetic navigation sensor 11 into the first connecting piece, and then insert it into the sensor assembly channel 1013 until the distal end of the first electromagnetic navigation sensor 11 reaches the target position at the distal end of the sensor assembly channel 1013.

[0066] Considering that when the operator performs a biopsy, the housing (also called the handle) of the fully automatic biopsy needle held by the operator will twist. If the first electromagnetic navigation sensor 11 is fixed to the biopsy needle assembly 1, the first electromagnetic navigation sensor 11 will twist with the twisting of the housing, thereby causing the first electromagnetic navigation sensor 11 to be damaged by the torque generated by the twisting. Therefore, in this embodiment, the connection between the first connecting member and the connecting through hole 12 is set so that the first connecting member can rotate relative to the connecting through hole under external torque. In this way, when the first electromagnetic navigation sensor 11 is subjected to the torque of the external force, the first electromagnetic navigation sensor 11 can adaptively rotate with the first connecting member relative to the navigation device and the biopsy needle assembly 1, thereby preventing the first electromagnetic navigation sensor 11 from being damaged by the torque or affecting the positioning accuracy.

[0067] More specifically, in this embodiment, Figure 7 and Figure 8 As shown, the distal end of the first connector is provided with a connector cap 13, which can be inserted into the connecting through hole 12, and an annular groove is provided on the side wall of the connector cap 13. Correspondingly, an annular protrusion 23 is provided on the inner wall of the connecting through hole 12, and the annular protrusion 23 cooperates with the annular groove. When the first electromagnetic navigation sensor is subjected to an external torque, the first connector fixed relatively to the first electromagnetic navigation sensor can rotate relative to the connecting through hole under the cooperation of the annular protrusion 23 and the annular groove. It should be noted that the present application does not limit the positions of the annular groove and the annular protrusion 23. In some other embodiments, the side wall of the connector cap 13 is formed with an annular protrusion 23, and the inner wall of the connecting through hole 12 is formed with an annular groove.

[0068] More specifically, the proximal end of the first electromagnetic navigation sensor 11 is sleeved with a second connector, the distal end of the first electromagnetic navigation sensor 11 passes through the distal end of the second connector, the first electromagnetic navigation sensor 11 and the second connector are fixedly arranged, and the distal end of the second connector is detachably connected to the proximal end of the first connector. In this way, when the first electromagnetic navigation sensor 11 needs to be assembled, the operator can hold the second connector and connect the distal end of the second connector to the proximal end of the first connector installed on the connecting through hole 12, thus completing the assembly of the first electromagnetic navigation sensor 11 on the fully automatic biopsy needle.

[0069] As a preferred implementation of this embodiment, the distal end of the second connector and the proximal end of the first connector are quickly detached. Specifically, the distal end of the second connector is set as a plug, and the proximal end of the first connector is set as a slot. During assembly, the plug can be quickly inserted into the slot to achieve connection. Of course, the positions of the plug and the slot can be interchanged. It should also be noted that the connection between the distal end of the second connector and the proximal end of the first connector can be a fixed connection or a rotating connection, which is not limited in this application.

[0070] In order to further ensure the accuracy of assembly, the connection between the second connecting member and the first connecting member is set so that when the two are connected in place, the distal end of the first electromagnetic navigation sensor 11 just extends into the target position of the sensor assembly channel 1013.

[0071] As a preferred implementation of this embodiment, Figure 7 and Figure 8 As shown, the first connecting member is the first connecting tube 22, the second connecting member is the second connecting tube (not shown in the figure), and the inner diameter of the first connecting tube 22 is larger than the outer diameter of the first electromagnetic navigation sensor 11, that is, there is a gap between the first connecting tube 22 and the first electromagnetic navigation sensor 11, which makes it easier to insert the first electromagnetic navigation sensor 11, and the second connecting tube is fixed to the first electromagnetic navigation sensor 11.

[0072] As an example of the above preferred embodiment, the first electromagnetic navigation sensor 11 is a thin and long wire, and the second connecting tube can be a split structure, which includes a first connecting sub-tube on the distal side and an insulating skin wrapped around the outside of the wire on the proximal side, the wire is fixed in the insulating skin, and the first connecting sub-tube of the second connecting tube and the first connecting tube 22 are both plastic transparent tubes. When making the first electromagnetic navigation sensor 11, the wire without the insulating skin on the distal side is inserted into the first connecting sub-tube, and then the distal end of the insulating skin is fixed to the proximal end of the first connecting sub-tube by a heat shrink tube (other fastening methods can also be used). When assembling the first electromagnetic navigation sensor 11, the operator holds the first connecting sub-tube or the insulating skin on the outside of the wire to insert the wire on the distal side into the first connecting tube 22 until the wire on the distal side extends into the distal end of the sensor assembly channel 1013 of the biopsy needle. Then the operator can quickly plug the distal end of the first connecting sub-tube and the proximal end of the first connecting tube 22 together, and the wire end on the distal side just extends into the target position at the distal end of the sensor assembly channel 1013, thereby completing the assembly of the first electromagnetic navigation sensor 11.

[0073] It should be noted that in this embodiment, the sensor is preferably arranged at the distal end of the wire. However, this application is not limited to this. In some other embodiments, there may be multiple sensors, which can be arranged at other positions along the wire in addition to being arranged at the distal end of the wire.

[0074] In addition, in this embodiment, during actual assembly, the operator first connects the first connecting tube 22 to the connecting through hole through the connecting cap 13, which is equivalent to providing an installation channel for the installation of the first electromagnetic navigation sensor 11. The operator then holds the second connecting tube to extend the first electromagnetic navigation sensor 11 into the first connecting tube 22, and then fixes the distal end of the second connecting tube to the proximal end of the first connecting tube 22. At this time, the first electromagnetic navigation sensor 11 just extends to the target position at the distal end of the sensor assembly channel 1013.

[0075] More specifically, the proximal end of the first electromagnetic navigation sensor 11 is provided with a quick-plug male connector, and the navigation device is provided with a quick-plug female connector for cooperating with the quick-plug male connector. The quick-plug male connector and the quick-plug female connector can form a fixed mechanical connection, and the quick-plug male connector and the quick-plug female connector also realize the electrical connection between the first electromagnetic navigation sensor 11 and the navigation device. The positions of the quick-plug male connector and the quick-plug female connector can be interchanged.

[0076] The present application does not impose any restrictions on the detachable fixed connection between the distal end of the second connecting tube and the proximal end of the first connecting tube 22 , which can be a quick-insert fixed connection or a threaded connection, as long as the second connecting tube and the first connecting tube 22 can be fixed and detachable.

[0077] In actual use, the first connecting tube 22 and the fully-automatic biopsy needle are a set, and the first electromagnetic navigation sensor 11 and the second connecting tube are a set. The fully-automatic biopsy needle may have different length specifications according to actual conditions, and the length of the first electromagnetic navigation sensor 11 is usually fixed. In order to allow the first electromagnetic navigation sensor 11 to be able to extend into the target position of the fully-automatic biopsy needle of different length specifications, in this embodiment, the first connecting tube 22 is designed to have different length specifications to match the fully-automatic biopsy needle of different length specifications (for example, when the length of the fully-automatic biopsy needle is shorter, the length of the first connecting tube 22 is longer) to ensure that when the first connecting tube 22 and the second connecting tube are connected, the first electromagnetic navigation sensor 11 can be extended into the target position of the fully-automatic biopsy needle.

[0078] In this embodiment, Figure 4 and Figure 5 As shown, the housing also includes a fixed protection tube 14 disposed at the proximal end of the housing, into which the proximal end of the biopsy needle assembly 1 extends, and the fixed protection tube 14 is used to protect the biopsy needle assembly 1 and guide the first electromagnetic navigation sensor 11 to extend into the sensor assembly channel 1013 when the first electromagnetic navigation sensor 11 is assembled. The fixed protection tube 14 is provided to protect the first electromagnetic navigation sensor 11 on the one hand, thereby preventing the first electromagnetic navigation sensor 11 from being damaged when other components in the housing are in motion, and on the other hand, to guide the assembly of the first electromagnetic navigation sensor 11, so that the operator can more easily extend the first electromagnetic navigation sensor 11 into the target position of the sensor channel 1013.

[0079] In order to accurately locate the positions of the needle tip 1012 and the sampling slot 1014, in the present embodiment, further, the center of the fixed protection tube 14 and the connecting through hole 12 are aligned with the center of the sensor assembly channel 1013. Thus, on the one hand, during assembly, the center of the first electromagnetic navigation sensor 11 can be aligned with the center of the sensor assembly channel 1013, which is beneficial for the navigation device to obtain the spatial positions of the needle tip 1014 and the sampling slot 1014 according to the specific spatial position of the first electromagnetic navigation sensor 11 and the specific dimensions and relative position relationship between the first electromagnetic navigation sensor 11 and the needle tip 1012 and the sampling slot 1014. On the other hand, after the center of the fixed protection tube 14 is aligned with the center of the sensor assembly channel 1013, the first electromagnetic navigation sensor 11 can be extended in a straight line to the distal end of the needle body 1011, which can prevent the pulling force generated at the moment of the needle body 1011 popping out from breaking the first electromagnetic navigation sensor 11.

[0080] In this embodiment, the needle tube 102 is used to cooperate with the sampling groove 1014 on the needle tip 1012 to complete sampling.

[0081] Furthermore, a ring blade is provided at the end of the needle tube 102. When the needle tube 102 slides relative to the needle body 1011, the ring blade can cooperate with the sampling groove 1014 to cut and separate the tissue sample in the sampling groove 1014 from the tissue to obtain the tissue sample.

[0082] In this embodiment, the needle tip 1012 is separately provided on the needle body 1011, so that the needle tip 1012 and the needle body 1011 can be processed separately. The needle tip 1012 is a solid structure, and the sampling slot 1014 is provided on the needle tip 1012. Further, a plug connector is provided at the end of the needle body 1011, and a plug hole matching the plug connector is provided at the end of the needle tip 1012. The plug connector is inserted into the plug hole to achieve the installation of the needle tip 1012 on the needle body 1011. Specifically, the plug connector can be a cylinder integrally formed with the needle body 1011, and the plug hole is a blind hole provided on the needle tip 1012 and matching the diameter of the cylinder. The needle tip 1012 is connected to the needle body 1011 by inserting the cylinder into the blind hole, wherein glue or adhesive can be applied or welded between the cylinder and the blind hole to make the connection between the needle tip 1012 and the needle body 1011 more firmly.

[0083] In this embodiment, the needle core 101 and the needle tube 102 are slidably arranged, and the needle tube 102 is slidably sleeved on the outside of the needle core 101. The needle core 101 and the needle tube 102 slide in sequence. The needle core 101 first moves to the target position, and the tissue at the target position is filled into the sampling groove 1014. The needle tube 102 then slides relative to the needle core 101. During the sliding process of the needle tube 102, the annular blade at the end thereof cuts and separates the tissue located in the sampling groove 1014 from other tissues when passing through the sampling groove 1014 to complete the sampling work.

[0084] In this embodiment, rubber sleeves can be put on the ends of the needle core 101 and the needle tube 102. When the fully automatic biopsy needle is not in use, the rubber sleeves can be put on the ends of the needle core 101 and the needle tube 102 to protect the ends of the needle core 101 and the needle tube 102 and prevent dust and the like from falling into the needle tube 102.

[0085] In this embodiment, Figure 6 , Fig. 9 and Fig.10As shown, it also includes a firing assembly 6 and a trigger assembly 5, which are arranged in the shell 2. The firing assembly 6 is connected to the biopsy needle assembly 1. The firing assembly 6 has an energy storage state that causes the biopsy needle assembly 1 to retract into the shell 2. The firing assembly 6 also has a firing state that causes the needle core 101 and the needle tube 102 in the biopsy needle assembly 1 to pop out in sequence. The firing assembly 6 drives the needle core 101 and the needle tube 102 to extend outward toward the distal end of the shell 2 in sequence, so that there is a time difference in the process of extending the needle core 101 and the needle tube 102, so that the needle core 101 and the needle tube 102 complete the biopsy sampling; the trigger assembly 5 can drive the firing assembly 6 to switch from the energy storage state to the firing state.

[0086] Furthermore, in this embodiment, the trigger assembly 5 includes a trigger key and a trigger link 15. The trigger key can be pressed and installed on the proximal end surface of the shell. The trigger link 15 is installed in the shell and is located on the distal side of the trigger key. When the operator presses the trigger key, the trigger key drives the trigger link 15 to move from the initial position to the trigger position. When the trigger link 15 moves to the trigger position, it triggers the firing assembly 6. The firing assembly 6 switches from the energy storage state to the firing state, driving the biopsy needle assembly 1 to extend to the distal end of the shell for biopsy sampling.

[0087] In this embodiment, the trigger link 15 has elastic wings 52 extending on opposite sides, and a retaining wall for resisting the elastic wings 52 is formed in the trigger component mounting cavity. When the trigger link 15 moves from the initial position to the trigger position, the retaining wall resists the elastic wings 52 to cause the elastic wings 52 to deform and store energy. After the trigger key releases the drive on the trigger link 15, the trigger link 15 drives the rear trigger key 3 to automatically move from the trigger position to the initial position under the deformation recovery action of the elastic wings 52, so that the trigger link 15 can automatically return to its position.

[0088] Furthermore, the trigger link 15 is formed with a third slider 51, and the elastic wings 52 extend from both sides of the third slider 51. When the third slider 51 moves to the trigger position, the end of the third slider 51 can drive the firing assembly 6 to switch from the energy storage state to the firing state.

[0089] In this embodiment, the shell body includes an outer shell 2 and an inner shell. The inner shell is formed by buckling a first inner shell 7 and a second inner shell 8. The outer shell 2 is sleeved on the outside of the inner shell. The inner shell includes a firing assembly mounting cavity on the distal side and a trigger assembly mounting cavity on the proximal side, as well as a biopsy needle assembly mounting cavity located on one side of the firing assembly mounting cavity and the trigger assembly mounting cavity and penetrating the inner shell and the outer shell 2. The firing assembly 6, the trigger assembly 5 and the biopsy needle assembly 1 are respectively assembled in the firing assembly mounting cavity, the trigger assembly mounting cavity and the biopsy needle assembly mounting cavity.

[0090] In this embodiment, the firing assembly 6 includes a first sub-firing assembly 61 and a second sub-firing assembly 62. The firing assembly mounting cavity has a first cavity and a second cavity. The first sub-firing assembly 61 is installed in the first cavity, and the second sub-firing assembly 62 is installed in the second cavity. The needle core 101 is connected to the first sub-firing assembly 61, and the needle tube 102 is connected to the second sub-firing assembly 62. The first sub-firing assembly 61 and the second sub-firing assembly 62 enter the firing state in sequence, so that the needle core 101 and the needle tube 102 pop out in a preset order.

[0091] Furthermore, the first sub-firing assembly 61 includes a first slider 611 and a first elastic member 612, and the second sub-firing assembly 62 includes a second slider 621 and a second elastic member 622; the needle core 101 is fixedly connected to the first slider 611, and the first slider 611 has an energy storage state in the first cavity for compressing the first elastic member 612 to shrink the needle core 101, and the first slider 611 also has a firing state in the first cavity for driving the needle core 101 to pop out under the elastic force of the first elastic member 612; the needle tube 102 is fixedly connected to the second slider 621, and the second slider 621 is slidably installed in the second cavity, and the second slider 621 has an energy storage state in the second cavity for compressing the second elastic member 622 to shrink the needle tube 102, and the second slider 621 also has a firing state in the second cavity for driving the needle tube 102 to pop out under the elastic force of the second elastic member 622.

[0092] Specifically, the first end of the first slider 611 has a first clamping portion, and the first cavity has a first clamping groove 16 that cooperates with the first clamping portion. When the first clamping portion is clamped into the first clamping groove 16, the first slider 611 enters an energy storage state. When the first clamping portion is separated from the first clamping groove 16, the first slider 611 enters a firing state. The trigger assembly 5 can drive the first clamping portion to separate from the first clamping groove 16, so that the first slider 611 enters a firing state from the energy storage state, driving the needle core 101 to pop out; the first end of the second slider 621 The end has a second clamping portion, and the second cavity has a second clamping groove 17 that cooperates with the second clamping portion. When the second clamping portion is clamped into the second clamping groove 17, the second slider 621 enters an energy storage state. When the second clamping portion is disengaged from the second clamping groove 17, the second slider 621 enters a firing state. When the first slider 611 slides to the far end of the first cavity, the second clamping portion can be pushed out of the second clamping groove 17, so that the second clamping portion is disengaged from the second clamping groove 17, and the second slider 621 enters a firing state, driving the needle tube 102 to pop out.

[0093] In this embodiment, a first elastic block 6111 is formed at the first end of the first slider 611, and the first elastic block 6111 passes through the first slot 16 and is engaged with the side of the first slot 16, so that the first slider 611 maintains an energy storage state. When the third slider 51 slides to the trigger position, the first elastic block 6111 is disengaged from the first slot 16, and the first slider 611 enters a firing state, driving the needle core 101 to extend outward toward the far end of the housing 2; a second elastic block 6211 is formed at the first end of the second slider 621, and the second elastic block 6211 passes through the first slot 16 and is engaged with the side of the first slot 16, so that the first slider 611 maintains an energy storage state. When the third slider 51 slides to the trigger position, the first elastic block 6111 is disengaged from the first slot 16, and the first slider 611 enters a firing state, driving the needle core 101 to extend outward toward the far end of the housing 2; The elastic block 6211 passes through the second slot 17 and is engaged with the side of the second slot 17 to keep the second slider 621 in an energy storage state. When the first slider 611 slides to the tail end of the first cavity, the end of the first slider 611 squeezes the second elastic block 6211 to disengage the second elastic block 6211 from the second slot 17. The second slider 621 enters a firing state, driving the needle tube 102 to extend toward the distal end of the housing 2. When the needle core 101 and the needle tube 102 extend toward the distal end of the housing 2, biopsy sampling of the target position is completed.

[0094] In this embodiment, the outer diameter of the first elastic block 6111 away from the trigger component 5 is larger than the outer diameter of the first elastic block 6111 close to the trigger component 5, so that when the first slider 611 is storing energy, the first elastic block 6111 is squeezed by the side wall of the first slot 16, and the first elastic block 6111 is radially offset inward, so that the first elastic block 6111 can enter the first slot 16 and pass through the first slot 16. After the first elastic block 6111 passes through the first slot 16, there is no squeezing of the side wall of the first slot 16, and the first elastic block 6111 is radially offset outward to expand, so that the first elastic block 6111 is engaged with the side of the first slot 16, preventing the first elastic block 6111 from sliding out of the first slot 16, so that the first slider 611 maintains the energy storage state.

[0095] Similarly, the outer diameter of the end of the second elastic block 6211 away from the first slider 611 is larger than the outer diameter of the end of the second elastic block 6211 close to the first slider 611, so that when the second slider 621 is storing energy, the second elastic block 6211 is squeezed by the side wall of the second slot 17, and the second elastic block 6211 is radially offset inward, so that the second elastic block 6211 can enter the second slot 17 and pass through the second slot 17. After the second elastic block 6211 passes through the second slot 17, it is no longer squeezed by the side wall of the second slot 17. The second elastic block 6211 is radially offset outward to expand, so that the second elastic block 6211 is engaged with the side of the second slot 17, preventing the second elastic block 6211 from sliding out of the second slot 17, so that the second slider 621 maintains the energy storage state.

[0096] In this embodiment, the first cavity and the second cavity are connected, and the first cavity and the second cavity are arranged in the moving direction of the needle core 101 and the needle body 1011, so that when the first slider 611 and the second slider 621 slide in the first cavity and the second cavity, it is easy to drive the needle core 101 and the needle body 1011 to move. At the same time, when the first slider 611 slides to the tail end of the first cavity, it can squeeze the second elastic block 6211, so that the second slider 621 switches from the energy storage state to the firing state, so that the second slider 621 drives the needle tube 102 to extend toward the distal end of the shell 2.

[0097] In some other embodiments, the first cavity and the second cavity may also be provided separately, and the first slider 611 and the second slider 621 may be triggered separately, as long as the first slider 611 and the second slider 621 are triggered in sequence.

[0098] In this embodiment, the inner shell includes a first inner shell 7 and a second inner shell 8, and the first inner shell 7 and the second inner shell 8 are buckled together. The first inner shell 7 and the second inner shell 8 are both installed in the outer shell 2. The first cavity and the second cavity are formed in the internal space of the first inner shell 7 and the second inner shell 8, which is convenient for rational use of the space in the outer shell 2. The first cavity and the second cavity are formed by assembling the first inner shell 7 and the second inner shell 8, which reduces the processing cost of the outer shell 2 and increases the applicability of the outer shell 2. Other types of first inner shells 7 and second inner shells 8 can also be assembled to install biopsy needle assemblies 1 of different specifications and models.

[0099] In this embodiment, Fig.10 and Fig.11 As shown, the end of the first elastic block 6111 facing the third slider 51 has a first inclined surface 6112, and the inclination direction of the first inclined surface 6112 is inclined upward from the direction close to the third slider 51 to the direction away from the third slider 51. The radial dimension of the first inclined surface 6112 is smaller than the inner diameter of the first slot 16, so that when the first slider 611 slides, the first inclined surface 6112 partially enters the first slot 16 first, and as the first inclined surface 6112 gradually enters, the inner wall of the first slot 16 begins to squeeze the first inclined surface 6112. The inclined surface 6112 causes the first elastic block 6111 to contract radially inward and eventually completely enter the first slot 16. After passing through the first slot 16, due to the lack of restriction from the inner wall of the first slot 16, the first elastic block 6111 expands radially outward under the action of its own elastic force and recovers its deformation. At this time, the radial dimension of the end of the first elastic block 6111 facing the first slot 16 is greater than the inner diameter of the first slot 16, thereby preventing the first elastic block 6111 from detaching from the first slot 16 and keeping the first slider 611 in an energy storage state.

[0100] Furthermore, the end of the third slider 51 facing the first slider 611 has a second inclined surface 511 matching the first inclined surface 6112. When the third slider 51 slides to the trigger position, the first elastic block 6111 moves radially inward under the squeezing of the second inclined surface 511, so that the radial dimension of the first elastic block 6111 is less than or equal to the inner diameter of the first slot 16, so that the first elastic block 6111 can break away from the restriction of the first slot 16 and enter the first slot 16. The first slider 611 switches from the energy storage state to the firing state under the action of the elastic force of the first elastic member 612, driving the needle core 101 to pop out toward the far end of the housing 2.

[0101] In this embodiment, the end of the second elastic block 6211 facing the first slider 611 has a third inclined surface 6212, and the inclination direction of the third inclined surface 6212 is inclined upward from the direction close to the first slider 611 to the direction away from the first slider 611. The radial dimension of the third inclined surface 6212 is smaller than the inner diameter of the second slot 17, so that when the second slider 621 slides, the third inclined surface 6212 partially enters the second slot 17 first, and as the third inclined surface 6212 gradually enters, the inner wall of the second slot 17 begins to squeeze The third inclined surface 6212 causes the second elastic block 6211 to contract radially inward and eventually completely enter the second slot 17. After passing through the second slot 17, due to the lack of restriction from the inner wall of the second slot 17, the second elastic block 6211 expands radially outward under the action of its own elastic force and recovers its deformation. At this time, the radial dimension of the end of the second elastic block 6211 facing the second slot 17 is greater than the inner diameter of the second slot 17, preventing the second elastic block 6211 from detaching from the second slot 17, so that the second slider 621 remains in an energy storage state.

[0102] Furthermore, the end of the first slider 611 facing the second slider 621 has a fourth inclined surface 18 matching the third inclined surface 6212. When the first slider 611 slides to the tail end of the first cavity, the second elastic block 6211 moves radially inward under the squeezing of the fourth inclined surface 18, so that the radial dimension of the second elastic block 6211 is less than or equal to the inner diameter of the second slot 17, so that the second elastic block 6211 can break away from the restriction of the second slot 17 and enter the second slot 17. The second slider 621 switches from the energy storage state to the firing state under the elastic force of the second elastic member 622, driving the needle tube 102 to pop out toward the far end of the shell 2.

[0103] Furthermore, the elastic wing 52 is an elastic plate extending outward from the third slider 51, such as a plate-shaped component formed of a rubber material. There are two elastic plates, which are respectively located on both sides of the third slider 51. One end of the elastic plate is connected to the third slider 51, and the other end abuts or is connected to the inner wall of the inner shell.

[0104] In this embodiment, an avoidance hole is formed on the elastic wing 52, through which the fixed protection tube 14 passes, and which avoids interference with the fixed protection tube 14 when the trigger link 15 moves. The fixed protection tube 14 passes through the avoidance hole and is arranged corresponding to the needle body 1011. The diameter of the avoidance hole is slightly larger than the outer diameter of the fixed protection tube 14, so that when the trigger link 15 slides and drives the elastic wing 52 to deform, the avoidance hole can move slightly on the fixed protection tube 14, thereby preventing the avoidance hole of the elastic wing 52 from being tightly mounted on the fixed protection tube 14 and unable to move, thereby affecting the sliding of the trigger link 15.

[0105] In this embodiment, the trigger key includes a side trigger key 4 and a rear trigger key 3, which are respectively arranged on the side and tail end of the handle formed by the shell 2. The side trigger key 4 and the rear trigger key 3 are connected by a trigger link 15. The side trigger key 4 and the rear trigger key 3 move synchronously. No matter which trigger key the operator presses, the other trigger key moves synchronously. The trigger link 15 is connected to the third slider 51. The side trigger key 4 and the rear trigger key 3 are both connected to the third slider 51 through the trigger link 15. The trigger link 15 is slidably arranged in the shell 2, so that no matter the operator operates the side trigger key 4 or the rear trigger key 3, the trigger link 15 can drive the third slider 51 to move from the initial position to the trigger position.

[0106] In this embodiment, it also includes a first push button 10 and a second push button 9. The first push button 10 and the second push button 9 are both slidably installed in the shell 2. The first push button 10 and the second push button 9 are at least partially exposed on the outside of the shell 2. The first push button 10 is fixedly connected to the first slider 611, and the second push button 9 is fixedly connected to the second slider 621. By pressing the first push button 10, the operator can control the first slider 611 to retract and move into the shell 2 to the energy storage state. By pressing the second push button 9, the operator can control the second slider 621 to retract and move into the shell 2 to the energy storage state.

[0107] When performing a biopsy using the fully automatic biopsy needle of this embodiment, the operator first needs to assemble the first electromagnetic navigation sensor 11 onto the biopsy needle assembly 1. Specifically, the operator can first adjust the biopsy needle assembly 1 to the energy storage state, that is, by pressing the key, the firing assembly 6 drives the biopsy needle assembly 1 to retract inward in the proximal direction of the shell to the energy storage state, and then extend the distal end of the first electromagnetic navigation sensor 11 to the target position at the distal end of the sensor assembly channel 1013. The proximal end of the first electromagnetic navigation sensor 11 passes through the proximal end of the fully automatic biopsy needle and is connected to the navigation device. At this time, after power is turned on, the navigation device can identify the spatial position (position and posture) of the first electromagnetic navigation sensor 11, and then determine the spatial position (position and posture) of the needle tip 1012 and the sampling slot 1014 of the biopsy needle assembly 1 according to the specific size relationship between the distal target position of the sensor assembly channel 1013 and the needle tip 1012 and the sampling slot 1014. The operator can then select a needle insertion point on the body surface and adjust the needle insertion path according to the navigation, confirm that the pre-puncture target is on the needle insertion path, and that the crosshairs used to indicate the position of the needle tip 1012 are on the pre-puncture target point, and then insert the biopsy needle assembly 1 into the target target point of the human body.

[0108] It should be noted that, in some embodiments, the navigation device reserves a firing distance for the biopsy needle assembly 1, that is, when the crosshairs of the biopsy needle assembly 1 are located at the pre-puncture target point according to the navigation, the actual position of the needle tip 1012 of the biopsy needle assembly 1 is still a firing distance away from the target target point. At this time, the operator controls the firing assembly 6 to drive the biopsy needle assembly 1 to switch from the energy storage state to the firing state, and the needle tip 1012 of the biopsy needle assembly 1 will just pierce the target sampling position (target target point).

[0109] It should also be noted that before the biopsy needle assembly 1 is fired, the locking assembly is always in the locked position to prevent the operator from accidentally triggering it. When the crosshairs of the biopsy needle assembly 1 are aimed at the pre-puncture target, the locking assembly is switched from the locked position to the unlocked position, and the trigger assembly 5 is operated to trigger the firing assembly 6, so that the firing assembly 6 switches from the energy storage state to the firing state to complete the sampling of the target tissue. Example 2

[0110] This embodiment provides a specific implementation of a biopsy system based on electromagnetic positioning, including the fully automatic biopsy needle, the second electromagnetic navigation sensor and the navigation device in Example 1. When in use, the second electromagnetic navigation sensor is fixedly connected to the ultrasound probe. The navigation device is configured to extract the electromagnetic signals received by the first electromagnetic navigation sensor 11 and the second electromagnetic navigation sensor, and determine the spatial position relationship between the fully automatic biopsy needle and the ultrasound probe based on the electromagnetic signals.

[0111] Furthermore, in this embodiment, the ultrasound probe is an intraoperative ultrasound probe, and the second electromagnetic navigation sensor is snapped to the transmitting acoustic window at the distal end of the ultrasound probe through a snap assembly. It should be noted that the present application is not limited to the ultrasound probe being an intraoperative ultrasound probe, but may also be an ultrasound probe used in vitro.

[0112] When the ultrasound probe is an intraoperative ultrasound probe, the navigation device can position the needle tip and sampling slot of the fully-automatic biopsy needle and the intraoperative ultrasound probe by positioning the first electromagnetic navigation sensor 11 and the second electromagnetic navigation sensor, thereby obtaining the relative position relationship between the needle tip of the fully-automatic biopsy needle and the intraoperative ultrasound probe. The navigation device can also use the relative position relationship to display on a display device, so that the operator can perform biopsy sampling on the patient under the display of the display device and the real-time image of the internal organs taken by the intraoperative ultrasound probe, which can greatly improve the biopsy efficiency and accuracy.

[0113] Those skilled in the art will easily think of other embodiments of the present application after considering the specification and practicing the embodiments of the present application. The present application is intended to cover any modification, use or adaptation of the present application, which follows the general principles of the present application and includes common knowledge or customary techniques in the art that the present application does not apply for. The specification and embodiments are only regarded as exemplary, and the true scope and spirit of the present application are pointed out by the appended claims.

Claims

1. A fully automatic biopsy needle, characterized in that: include: a housing, a firing assembly, a trigger assembly, a biopsy needle assembly, and a first electromagnetic navigation sensor; The firing assembly, the trigger assembly, the biopsy needle assembly and the first electromagnetic navigation sensor are assembled on the housing; The firing assembly is connected to the biopsy needle assembly, and the firing assembly has an energy storage state in which the biopsy needle assembly is retracted toward the proximal end of the housing, and a firing state in which the biopsy needle assembly is extended toward the distal end of the housing under the triggering of the trigger assembly. During the switching process from the energy storage state to the firing state, the biopsy needle assembly completes biopsy sampling; The trigger assembly is used to trigger the firing assembly to switch the firing assembly from the energy storage state to the firing state; The biopsy needle assembly comprises a needle core and a needle tube which are sleeved together, the needle core comprises a needle tip arranged at a distal end and a needle body connected to a proximal end of the needle tip and extending toward the proximal end of the housing, a hollow sensor assembly channel is formed inside the needle body, and the sensor assembly channel extends along the length direction of the needle body; The first electromagnetic navigation sensor is an elongated structure. When the firing assembly is in the energy storage state, the first electromagnetic navigation sensor extends to a target position at the far end of the sensor assembly channel. When the firing assembly drives the biopsy needle assembly to switch from the energy storage state to the firing state, the first electromagnetic navigation sensor is fixed; A connecting through hole is opened at the proximal end of the shell, and the connecting through hole is communicated with the sensor assembly channel. The connecting through hole is used to install a first connecting piece. The distal end of the first electromagnetic navigation sensor passes through the first connecting piece and extends into the target position of the sensor assembly channel. The proximal end of the first electromagnetic navigation sensor is suitable for connecting to a navigation device. The first electromagnetic navigation sensor and the first connecting piece are relatively fixedly arranged.

2. The fully automatic biopsy needle according to claim 1, characterized in that: The connection between the first connecting member and the connecting through hole is configured such that the first connecting member can rotate relative to the connecting through hole under an external force torque.

3. The fully automatic biopsy needle according to claim 2, characterized in that: A connecting cap is provided at the distal end of the first connecting member, and the connecting cap is inserted into the connecting through hole. An annular protrusion or an annular groove is provided on the side wall of the connecting cap, and an annular groove or annular protrusion is provided on the inner wall of the connecting through hole. The connecting cap is rotatably connected to the connecting through hole through the cooperation of the annular protrusion and the annular groove.

4. The fully automatic biopsy needle according to claim 3, characterized in that: The proximal end of the first electromagnetic navigation sensor is sleeved with a second connecting piece, the distal end of the first electromagnetic navigation sensor passes through the distal end of the second connecting piece, the first electromagnetic navigation sensor and the second connecting piece are fixedly arranged, and the distal end of the second connecting piece is detachably connected to the proximal end of the first connecting piece; when the distal end of the second connecting piece is connected to the proximal end of the first connecting piece in place, the distal end of the first electromagnetic navigation sensor extends into the target position of the sensor assembly channel.

5. The fully automatic biopsy needle according to claim 4, characterized in that: The first connecting member is a first connecting pipe, and the second connecting member is a second connecting pipe.

6. The fully automatic biopsy needle according to any one of claims 1 to 5, characterized in that: A fixed protective tube is arranged inside the proximal end of the shell, and the centers of the fixed protective tube, the connecting through hole and the sensor assembly channel are aligned. The first electromagnetic navigation sensor passes through the connecting through hole and the fixed protective tube and extends into the sensor assembly channel.

7. The fully automatic biopsy needle according to claim 6, characterized in that: The proximal end of the needle core extends into the fixed protective tube, and the length of the needle core extending into the fixed protective tube is set so that the needle core will not fall out from the distal port of the fixed protective tube when the needle core is fired with the firing assembly, and will not extend from the proximal port of the fixed protective tube when the needle core is switched to the energy storage state with the firing assembly.

8. The fully automatic biopsy needle according to any one of claims 1 to 5, characterized in that: The target location is the distal end of the sensor mounting channel.

9. The fully automatic biopsy needle according to any one of claims 1 to 5, characterized in that: The needle tip and the needle body are arranged separately, and the proximal end of the needle tip and the distal end of the needle body are connected by bonding or welding.

10. The fully automatic biopsy needle according to any one of claims 1 to 5, characterized in that: The firing assembly includes a first sub-firing assembly arranged at the proximal end and a second sub-firing assembly arranged at the distal end. The shell has a first cavity arranged at the proximal end and a second cavity arranged at the distal end. The first sub-firing assembly is installed in the first cavity, and the second sub-firing assembly is installed in the second cavity. The needle core is connected to the first sub-firing assembly, and the needle tube is connected to the second sub-firing assembly. The first sub-firing assembly is triggered by the trigger assembly to switch from the energy storage state to the firing state, and at the same time drives the needle core to pop out in the distal direction. When the first sub-firing assembly switches to the firing state, it triggers the second sub-firing assembly to switch from the energy storage state to the firing state, and at the same time drives the needle tube to pop out in the distal direction.

11. The fully automatic biopsy needle according to claim 10, characterized in that: The first sub-firing assembly includes a first slider and a first elastic member, and the second sub-firing assembly includes a second slider and a second elastic member; The needle core is fixedly connected to the first slider, and the first slider is slidably installed in the first cavity. The first slider has an energy storage state in the first cavity for compressing the first elastic member to shrink the needle core, and the first slider also has a firing state in the first cavity for driving the needle core to pop out; The needle tube is fixedly connected to the second slider, and the second slider is slidably installed in the second cavity. The second slider has an energy storage state in the second cavity for compressing the second elastic member to shrink the needle tube, and the second slider also has a firing state in the second cavity for driving the needle tube to pop out.

12. The fully automatic biopsy needle according to claim 11, characterized in that: The trigger assembly includes a trigger key and a trigger connecting rod, the trigger key is connected to the trigger connecting rod, and the trigger key and the trigger connecting rod are both slidably mounted in the housing, and the trigger key and the trigger connecting rod switch between an initial position and a trigger position during sliding; When the trigger link slides to the trigger position, it is used to push the first elastic member out of the first slot, so that the first slider switches from the energy storage state to the firing state.

13. The fully automatic biopsy needle according to claim 12, characterized in that: The trigger key includes a side trigger key and a rear trigger key, and both the side trigger key and the rear trigger key are fixedly connected to the trigger connecting rod. The side trigger key is arranged on the side of the shell, and the rear trigger key is arranged at the proximal end of the shell.

14. A biopsy system based on electromagnetic positioning, characterized in that: comprising a fully automatic biopsy needle, a second electromagnetic navigation sensor and a navigation device according to any one of claims 1 to 13; The second electromagnetic navigation sensor is fixedly connected to the ultrasonic probe; The navigation device is configured to extract electromagnetic signals received by the first electromagnetic navigation sensor and the second electromagnetic navigation sensor, and use the electromagnetic signals to determine the spatial position relationship between the full-automatic biopsy needle and the ultrasound probe.

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