Fully automatic biopsy needle based on electromagnetic positioning

Abstract

The present application provides a fully automatic biopsy needle based on electromagnetic positioning, which belongs to the field of medical device technology, and specifically includes: a shell, a firing assembly, a trigger assembly, a biopsy needle assembly, a first electromagnetic navigation sensor, and a fixed protective tube; the shell is provided with a connecting through hole, the connecting through hole is used to install a first connecting member, and the fixed protective tube is aligned with the center of the connecting through hole and the sensor assembly channel; so that the first electromagnetic navigation sensor maintains a straight extension after extending into the sensor assembly channel, and when the trigger assembly triggers the firing assembly to enter a firing state, the firing assembly drives the biopsy needle to extend outward toward the distal direction of the shell. During the extension of the biopsy needle assembly, the sensor assembly channel moves together with the biopsy needle assembly, and the first electromagnetic navigation sensor maintains a straight extension at the center position of the sensor assembly channel, so that when the sensor state channel moves with the biopsy needle assembly, it will not affect or damage the first electromagnetic navigation sensor.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a fully automatic biopsy needle 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 has achieved automation in terms of emission and sampling, which improves the efficiency and accuracy of biopsy.

[0003] The fully automatic biopsy needle includes a biopsy needle assembly, a handle, a firing device, etc. The biopsy needle assembly consists of a needle core and a needle tube. The needle core is provided with a sampling groove. The firing device is used to control the needle core and the needle tube to pop out in sequence to complete the sampling.

[0004] In the related art, the operator 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 the positional relationship between the needle tip and the sampling slot and the target sampling position cannot be accurately grasped, and the operator can only rely on the operator's experience to operate. To this end, the applicant proposes a fully automatic biopsy needle combined with electromagnetic positioning. Specifically, a first electromagnetic navigation sensor is assembled on the fully automatic biopsy needle, and the electromagnetic navigation technology is used to accurately locate the needle tip and the sampling slot of the biopsy needle. However, when the above scheme is implemented, due to the large firing force of the firing device, the biopsy needle assembly is prone to damage to the first electromagnetic navigation sensor when the firing device is fired quickly, and may even cause the first electromagnetic navigation sensor to break, resulting in product failure and surgical failure. Summary of the invention

[0005] The purpose of the present application is to provide a fully automatic biopsy needle based on electromagnetic positioning, aiming to solve the problem that the first electromagnetic navigation sensor is easily damaged when the firing device and the biopsy needle assembly are fired quickly.

[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 based on electromagnetic positioning is provided, comprising:

[0008] Shell, firing assembly, trigger assembly, biopsy needle assembly, first electromagnetic navigation sensor, fixed protection tube;

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

[0010] A hollow sensor assembly channel is formed inside the biopsy needle assembly, and the sensor assembly channel extends along the length direction of the biopsy needle assembly;

[0011] 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 performs biopsy sampling;

[0012] The trigger assembly is used to trigger the firing assembly;

[0013] A connecting through hole is opened at the proximal end of the housing, and the fixed protection tube is fixedly arranged inside the proximal end of the housing and aligned with the center of the connecting through hole at the proximal end side and the sensor assembly channel at the distal end side;

[0014] The first electromagnetic navigation sensor is a slender structure, the distal end of which is suitable for passing through the connecting through hole and the fixed protection tube to extend into the target position at the distal end of the sensor assembly channel, and the proximal end of which is suitable for connecting to the navigation equipment.

[0015] In an exemplary embodiment of the present application, the biopsy needle assembly includes a needle core and a needle tube that are slidably connected, 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 in the proximal direction of the shell, the sensor assembly channel is formed inside the needle body, 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.

[0016] In an exemplary embodiment of the present application, the axial proximal side of the connecting through hole is used to install a first connecting piece, a channel is formed in the middle of the first connecting piece, and the distal end of the first electromagnetic navigation sensor is suitable for passing through the channel of the first connecting piece and through the fixed protective tube to be inserted into the target position of the sensor assembly channel of the needle body, and the first connecting piece and the first electromagnetic navigation sensor are relatively fixedly arranged.

[0017] In an exemplary embodiment of the present application, the connection between the distal end of 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.

[0018] 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. A positioning protrusion or an annular groove is provided on the side wall of the connecting cap, and an annular groove or a positioning 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 positioning protrusion and the annular groove.

[0019] In an exemplary embodiment of the present application, the housing includes an outer shell and an inner shell, the outer shell is sleeved on the outer side of the inner shell, the inner shell includes a firing assembly installation cavity on the distal side and a trigger assembly installation cavity on the proximal side, and a biopsy needle assembly installation cavity located on one side of the firing assembly installation cavity and the trigger assembly installation cavity, and the firing assembly, the trigger assembly and the biopsy needle assembly are respectively assembled in the firing assembly installation cavity, the trigger assembly installation cavity and the biopsy needle assembly installation cavity;

[0020] The connecting through hole is formed on the proximal surface of the shell and communicates with the trigger assembly installation cavity. The proximal end of the fixed protection tube is fixed to the shell and communicates with the connecting through hole. The distal end of the fixed protection tube passes through the trigger assembly and extends to the biopsy needle assembly installation cavity.

[0021] In an exemplary embodiment of the present application, the trigger assembly has an initial position and a trigger position that moves along a trigger path toward the distal end of the housing to trigger the firing assembly to switch from the energy storage state to the firing state;

[0022] The trigger assembly comprises a rear trigger key and a trigger connecting rod, wherein the rear trigger key and the trigger connecting rod are both slidably mounted in the housing, and the rear trigger key and the trigger connecting rod switch between the initial position and the trigger position during the sliding process;

[0023] The trigger link has a pair of elastic wings extending to both sides, and a retaining wall for resisting the elastic wings is formed in the trigger component mounting cavity. When the trigger link moves from the initial position to the trigger position, the retaining wall resists the elastic wings to deform and store energy. After the rear trigger key releases the drive on the trigger link, the trigger link drives the rear trigger key to automatically move from the trigger position to the initial position under the deformation recovery action of the elastic wings.

[0024] In an exemplary embodiment of the present application, a avoidance hole for the fixed protection tube to pass through is opened on the elastic wing, and the avoidance hole is arranged so that the elastic wing does not interfere with the fixed protection tube when moving with the trigger connecting rod.

[0025] In an exemplary embodiment of the present application, the rear trigger key and the connecting through hole are distributed side by side on the end surface of the proximal end of the shell, and the rear trigger key and the trigger connecting rod are arranged separately.

[0026] In an exemplary embodiment of the present application, the rear trigger key is obliquely arranged on the end surface of the proximal end of the shell, and the rear trigger key is at least partially exposed on the outside of the shell.

[0027] The exemplary embodiments of the present application may have some or all of the following beneficial effects:

[0028] In the fully automatic biopsy needle based on electromagnetic positioning provided in the example implementation mode of the present application, a new structure of a fully automatic biopsy needle that can be combined with a first electromagnetic navigation sensor is first proposed. Specifically, the fully automatic biopsy needle includes a shell, a firing assembly, a trigger assembly, a biopsy needle assembly, a first electromagnetic navigation sensor, and a fixed protective tube. The firing assembly, the trigger assembly, the biopsy needle assembly, the first electromagnetic navigation sensor, and the fixed protective tube are assembled in the shell, wherein a hollow sensor assembly channel is formed inside the biopsy needle assembly, and the sensor assembly channel extends along the length direction of the biopsy needle assembly; the firing assembly is connected to the biopsy needle assembly, and the firing assembly has an energy storage state that drives the biopsy needle assembly to retract inward toward the proximal direction of the shell. state and a firing state in which the biopsy needle assembly is driven to extend outward toward the distal end of the shell body under the triggering of the trigger assembly. During the switching process from the energy storage state to the firing state, the biopsy needle assembly performs biopsy sampling, and the trigger assembly is used to trigger the firing assembly, so that the firing assembly switches from the energy storage state to the firing state; a connecting through hole is opened at the proximal end of the shell body, and a fixed protective tube is fixedly arranged inside the proximal end of the shell body and is aligned with the connecting through hole on the proximal side and the center of the sensor assembly channel on the distal side; the first electromagnetic navigation sensor is a slender structure, and its distal end is suitable for passing through the connecting through hole and the fixed protective tube to extend to the target position at the distal end of the sensor assembly channel, and the proximal end of the first electromagnetic navigation sensor is suitable for connecting with an external navigation device.

[0029] On the first aspect, by forming a hollow sensor assembly channel inside the biopsy needle assembly, and the sensor assembly channel extends along the length direction of the biopsy needle assembly, and the first electromagnetic navigation sensor is set to a slender structure, when in use, the distal end of the first electromagnetic navigation sensor is extended to the target position at the distal end of the sensor assembly channel, and the proximal end is passed through the proximal opening of the fully automatic biopsy needle to connect to the navigation device, so that the first electromagnetic navigation sensor can be positioned under the navigation device, and then the specific spatial position (position and posture) of the needle tip and the sampling slot of the biopsy needle assembly can be determined according to the target position and the set size relationship between the needle tip and the sampling slot of the biopsy needle assembly, which is beneficial for the operator to improve the efficiency and accuracy of the biopsy.

[0030] Secondly, considering the narrow space of the sensor assembly channel, it is difficult to design a fixing structure inside the sensor assembly channel for fixing the slender first electromagnetic navigation sensor, that is, the slender first electromagnetic navigation sensor is not fired together with the biopsy needle assembly when firing. Since the first electromagnetic navigation sensor is thin and long, it is difficult to ensure that the first electromagnetic navigation sensor and the proximal opening of the sensor assembly channel of the needle body are aligned when assembling the first electromagnetic navigation sensor. During biopsy sampling, since the firing device fires quickly (or instantly) when switching from the energy storage state to the firing state, the firing force is large. The rapid and large firing force can easily cause the sensor assembly channel of the needle body to form a rapid and large friction force on the first electromagnetic navigation sensor, and even form a shear force, thereby damaging or even shearing the first electromagnetic navigation sensor. An electromagnetic navigation sensor. Therefore, in the fully automatic biopsy needle provided by the exemplary embodiment of the present application, by setting a fixed protective tube at the proximal end of the shell and aligning the fixed protective tube with the connecting through hole on the proximal side and the center of the sensor assembly channel on the distal side, the setting of the fixed protective tube can, on the one hand, guide the first electromagnetic navigation sensor to penetrate into the sensor assembly channel of the needle body more conveniently. On the other hand, since the fixed protective tube and the sensor assembly channel are aligned in center, the first electromagnetic navigation sensor part located outside the proximal end of the needle body is also constrained to be aligned in center with the first electromagnetic navigation sensor part extending into the sensor assembly channel, that is, the first electromagnetic navigation sensor extending from the proximal end of the needle body still maintains a straight extension in the fixed protective tube. When the firing assembly drives the biopsy needle assembly to switch from the energy storage state to the firing state, the needle body and its sensor assembly channel that are fired rapidly in the distal direction will not cause damage to the first electromagnetic navigation sensor, and the sensor assembly channel will not cut off the first electromagnetic navigation sensor.

[0031] 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

[0032] 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.

[0033] Figure 1 A schematic structural diagram of a fully automatic biopsy needle based on electromagnetic positioning in Example 1 of the present application is shown;

[0034] Figure 2 An explosion diagram of a fully automatic biopsy needle based on electromagnetic positioning in Example 1 of the present application is shown;

[0035] Figure 3 A partial exploded view of a fully automatic biopsy needle based on electromagnetic positioning in Example 1 of the present application is shown;

[0036] 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;

[0037] Figure 5 Shows Figure 4 The enlarged schematic diagram at A in the middle;

[0038] Figure 6 A schematic diagram showing the connection between the first connecting tube, the connecting cap and the first electromagnetic navigation sensor in Example 1 of the present application is shown;

[0039] Figure 7 Shows Figure 6 The enlarged schematic diagram of point B in the middle;

[0040] Figure 8 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;

[0041] Fig. 9 A cross-sectional view of the firing assembly in embodiment 1 of the present application when in a firing state is shown;

[0042] Fig.10 A schematic diagram of the structure of the firing assembly in Example 1 of the present application is shown;

[0043] Fig.11 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.

[0044] Description of reference numerals:

[0045] 1. Biopsy needle assembly; 101. Needle core; 1011. Needle body; 1012. Needle tip; 1013. Sensor assembly channel; 1014. Sampling slot; 102. Needle tube;

[0046] 2. housing; 3. rear trigger key; 4. side trigger key; 5. trigger assembly; 51. third slider; 511. second inclined surface; 52. elastic wing;

[0047] 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;

[0048] 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 clamping hole; 17. Second clamping hole; 18. Fourth inclined surface; 19. Locking piece; 191. Avoidance inclined surface; 20. Fixed support plate; 21. Locking button; 22. First connecting tube; 23. Positioning protrusion. DETAILED DESCRIPTION

[0049] 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.

[0050] Although relative terms such as "upper" and "lower" are used in this specification to describe the relative relationship of one component of the diagram 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 diagram 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.

[0051] 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.

[0052] "Proximal" refers to the end closer to the operator, and "distal" refers to the end farther from the operator. Example 1

[0053] This embodiment provides a specific implementation of a fully automatic biopsy needle based on electromagnetic positioning, such as Figure 1 , Figure 2 , Figure 3 , Figure 4 and Figure 5As shown, it includes a shell, a firing assembly 6, a trigger assembly 5, a biopsy needle assembly 1, a first electromagnetic navigation sensor 11, and a fixed protective tube 14. The firing assembly 6, the trigger assembly 5, the biopsy needle assembly 1, the first electromagnetic navigation sensor 11, and the fixed protective tube 14 are assembled in the shell, wherein a hollow sensor assembly channel 1013 is formed inside the biopsy needle assembly 1, and the sensor assembly channel 1013 extends along the length direction of the biopsy needle assembly 1; 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 inward toward the proximal direction of the shell and a firing state for driving the biopsy needle assembly 1 to extend outward toward the distal direction of the shell under the triggering of the trigger assembly 5. State, during the switching process from the energy storage state to the firing state, the biopsy needle assembly 1 performs biopsy sampling, and the trigger assembly 5 is used to trigger the firing assembly 6, so that the firing assembly 6 switches from the energy storage state to the firing state; a connecting through hole 12 is opened at the proximal end of the shell, and a fixed protective tube 14 is fixedly arranged inside the proximal end of the shell and is aligned with the center of the connecting through hole 12 on the proximal side and the sensor assembly channel 1013 on the distal side; the first electromagnetic navigation sensor 11 is a slender structure, and its distal end is suitable for passing through the connecting through hole 12 and the fixed protective tube 14 to extend to the target position at the distal end of the sensor assembly channel 1013, and the proximal end of the first electromagnetic navigation sensor 11 is suitable for connecting with an external navigation device.

[0054] In this embodiment, in the first aspect, as Figure 5 , Figure 6 and Figure 7 As shown, by forming a hollow sensor assembly channel 1013 inside the biopsy needle assembly 1, and the sensor assembly channel 1013 extends along the length direction of the biopsy needle assembly 1, and the first electromagnetic navigation sensor 11 is set to a slender structure, when in use, the distal end of the first electromagnetic navigation sensor 11 is extended to the target position at the distal end of the sensor assembly channel 1013, and the proximal end is passed through the proximal opening of the full-automatic biopsy needle to connect to the navigation device, so that the first electromagnetic navigation sensor 11 can be positioned under the navigation device, and then the specific spatial position (position and posture) of the needle tip 1012 and the sampling slot 1014 of the biopsy needle assembly 1 can be determined according to the set size relationship between the target position and the needle tip 1012 and the sampling slot 1014, which is beneficial for the operator to improve the efficiency and accuracy of the biopsy.

[0055] Secondly, considering that the sensor assembly channel 1013 has a narrow space, it is difficult to design a fixing structure therein for fixing the slender first electromagnetic navigation sensor 11, that is, the slender first electromagnetic navigation sensor 11 is not fired together with the biopsy needle assembly when firing. Since the first electromagnetic navigation sensor 11 is thin and long, it is difficult to ensure that the first electromagnetic navigation sensor 11 and the proximal opening of the sensor assembly channel 1013 of the needle body 1011 are aligned with each other when assembling the first electromagnetic navigation sensor 11. During biopsy sampling, since the firing assembly 6 is fired quickly (it can also be said to be fired instantly) when switching from the energy storage state to the firing state, the firing force is large. The fast and large firing force can easily cause the sensor assembly channel 1013 of the needle body to form a fast and large friction force on the first electromagnetic navigation sensor 11, and even form a shear force, thereby damaging or even shearing the first electromagnetic navigation sensor 1 1. Therefore, in the fully automatic biopsy needle provided in the exemplary embodiment of the present application, by setting a fixed protective tube 14 at the proximal end of the shell and aligning the fixed protective tube 14 with the connecting through hole 12 on the proximal side and the center of the sensor assembly channel 1013 on the distal side, the setting of the fixed protective tube 14 can, on the one hand, guide the first electromagnetic navigation sensor 11 to penetrate into the sensor assembly channel 1013 of the needle body more conveniently; on the other hand, since the fixed protective tube 14 and the sensor assembly channel 1013 are kept centrally aligned, the part of the first electromagnetic navigation sensor 11 located on the proximal outer side of the needle body 1011 is also constrained to be centrally aligned with the part of the first electromagnetic navigation sensor 11 extending into the sensor assembly channel 1013, that is, the first electromagnetic navigation sensor 11 extending from the proximal outer side of the needle body 1011 still maintains a straight extension in the fixed protective tube 14. When the firing assembly 6 drives the biopsy needle assembly 1 to switch from the energy storage state to the firing state, the needle body 1011 and its sensor assembly channel 1013 that are quickly fired in the distal direction will not cause damage to the first electromagnetic navigation sensor 11, and the sensor assembly channel 1013 will not shear off the first electromagnetic navigation sensor 11.

[0056] In this embodiment, Fig.11As shown, the biopsy needle assembly 1 includes a movably sleeved needle core 101 and a needle tube 102, the needle core 101 includes a needle tip 1012 arranged at the distal end and a needle body 1011 connected to the proximal end of the needle tip 1012 and extending toward the proximal end of the shell, a sensor assembly channel 1013 is formed inside the needle body 1011, the proximal end of the needle core 101 extends into the fixed protective tube 14, the length of the needle core 101 extending into the fixed protective tube 14 is set so that the needle core 101 will not fall out from the distal end port of the fixed protective tube 14 when the firing assembly 6 is fired, and the needle core 101 will not extend from the proximal end port of the fixed protective tube 14 when the firing assembly 6 is switched to the energy storage state. This design requires calculating the length of the needle body 1011 according to the size of the shell, the firing distance required to be fired, and the size of the fixed protective tube 14. The size ensures that when the firing assembly 6 is in the energy storage state and the firing state, the proximal end of the needle body 1011 is always in the fixed protective tube 14, and the proximal end of the needle body 1011 has never been separated from the fixed protective tube 14, further ensuring the accuracy of the center alignment of the fixed protective tube 14, the connecting through hole 12 and the sensor assembly channel 1013. At the same time, it can also avoid that after the sensor assembly channel 1013 is separated from the fixed protective tube 14, the first electromagnetic navigation sensor 11 is not convenient to extend into the sensor assembly channel 1013 through the guidance of the fixed protective tube 14. The proximal end of the needle body 1011 is always located in the fixed protective tube 14, which makes it convenient for the first electromagnetic navigation sensor 11 to extend into the sensor assembly channel 1013 through the guidance of the fixed protective tube 14, thereby ensuring that the first electromagnetic navigation sensor 11 extends in a straight line.

[0057] Furthermore, in order to facilitate the assembly of the first electromagnetic navigation sensor 11, a first connector is installed on the axial proximal side of the connecting through hole 12, and a channel for the first electromagnetic navigation sensor 11 to pass through is formed in the middle of the first connector. During assembly, the distal end of the first electromagnetic navigation sensor 11 passes through the connecting through hole 12 through the first connector, and then passes through the fixed protective tube 14, and extends all the way to the target position in the sensor assembly channel of the needle body. In order to ensure that the first electromagnetic navigation sensor 11 is not fired together with the needle body when firing, in this embodiment, the first connector and the first electromagnetic navigation sensor are relatively fixedly arranged. A specific example of the relatively fixed arrangement will be described in detail below.

[0058] Furthermore, in this embodiment, a connection cap 13 is provided at the distal end of the first connection member, and the connection cap 13 can be inserted into the connection through hole 12. Figure 6 and Figure 7As shown, the distal end of the first electromagnetic navigation sensor 11 passes through the connecting cap 13 and extends into the sensor assembly channel 1013. The connection between the connecting cap 13 and the connecting through hole 12 is configured so that the connecting cap 13 can rotate relative to the connecting through hole 12 under external torque. Among them, the position where the first electromagnetic navigation sensor 11 passes through the connecting cap 13 is the center position of the connecting through hole 12 after the connecting cap 13 is connected to the connecting through hole 12, further ensuring that the position where the first electromagnetic navigation sensor 11 passes through the connecting cap 13 is the center position of the connecting through hole 12; on the other hand, the connecting cap 13 is set to be able to rotate relative to the connecting through hole 12 under external force torque. When performing a biopsy, the operator holding the fully automatic biopsy needle may twist. If the fully automatic biopsy needle drives the first electromagnetic navigation sensor 11 to twist, it may cause the first electromagnetic navigation sensor 11 itself to twist, which is prone to damage. Therefore, by setting the connecting cap 13 to be able to rotate relative to the connecting through hole 12 under external force torque, when the operator twists or even rotates the fully automatic biopsy needle when operating the fully automatic biopsy needle, the connecting cap 13 and the first electromagnetic navigation sensor 11 will adaptively rotate relative to the shell of the fully automatic biopsy needle, thereby avoiding the first electromagnetic navigation sensor 11 from twisting itself and avoiding damage.

[0059] Furthermore, an annular groove is provided on the side wall of the connecting cap 13, and correspondingly, a positioning protrusion 23 is provided on the inner wall of the connecting through hole 12, and the positioning protrusion 23 cooperates with the annular groove. When the first electromagnetic navigation sensor is subjected to an external torque, the first connecting member fixed relatively to the first electromagnetic navigation sensor 11 can rotate relative to the connecting through hole 12 under the cooperation of the positioning 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 positioning protrusion 23. In some other embodiments, the positioning protrusion 23 is formed on the side wall of the connecting cap 13, and the annular groove is formed on the inner wall of the connecting through hole 12.

[0060] Furthermore, 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.

[0061] 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.

[0062] 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.

[0063] As a preferred implementation of this embodiment, Figure 6 and Figure 7 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.

[0064] 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.

[0065] 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.

[0066] In addition, in this embodiment, during actual assembly, the operator first connects the first connecting tube 22 to the connecting through hole 12 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.

[0067] 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.

[0068] In this embodiment, the biopsy needle assembly 1, the first electromagnetic navigation sensor 11, the firing assembly 6, the trigger assembly 5, and the locking assembly are all assembled on the shell; the biopsy needle assembly 1 is provided with a hollow sensor assembly channel 1013, and the sensor assembly channel 1013 is used to assemble the first electromagnetic navigation sensor 11. When in use, the operator extends the first electromagnetic navigation sensor 11 to the target position at the far end of the sensor assembly channel 1013, thereby identifying the spatial position of the first electromagnetic navigation sensor 11 under the navigation device, and then determining the spatial position of the biopsy needle assembly 1. The firing assembly 6 is connected to the biopsy needle assembly 1. The firing assembly 6 has an energy storage state in which the biopsy needle assembly 1 is retracted toward the proximal end of the shell and a firing state in which the biopsy needle assembly 1 is extended toward the distal end of the shell under the triggering of the trigger assembly 5. During the switching process from the energy storage state to the firing state, the biopsy needle assembly 1 performs biopsy sampling. The trigger assembly 5 is used to trigger the firing assembly 6 and is assembled on the proximal side of the firing assembly 6 on the shell. The trigger assembly 5 has an initial position and moves along a trigger path toward the distal end of the shell to trigger the firing assembly 6 from the energy storage state to the firing state. The locking member 19 is rotatably mounted on the proximal side of the shell, and the locking member 19 has an unlocked position and a locked position. The locked position is that the locking member 19 is rotated along the circumferential direction of the shell and inserted between the trigger assembly 5 and the firing assembly 6. When in the locked position, the locking member 19 blocks the trigger assembly 5 from moving toward the trigger position. A fixed support disk is formed in the shell, and the fixed support disk is configured so that the distal end of the locking member 19 abuts against the fixed support disk 20 when the locking member 19 is rotated to the locked position.

[0069] When performing a biopsy using the fully automatic biopsy needle of this embodiment, the operator first adjusts the fully automatic biopsy needle to the energy storage state, and then extends the first electromagnetic navigation sensor 11 to the target position at the far end of the sensor assembly channel 1013, and the proximal end of the first electromagnetic navigation sensor passes through the proximal end of the fully automatic biopsy needle and is connected to the navigation device. The navigation device can identify the spatial position of the first electromagnetic navigation sensor, and then determine the spatial position of the needle tip and the sampling slot according to the specific size relationship between the target position at the far end of the sensor assembly channel and the needle tip and the sampling slot of the biopsy needle assembly, and then pierce the human body according to the pre-planned surface puncture point and puncture path. Under the guidance of the navigation device, the operator can insert the fully automatic biopsy needle that drives the first electromagnetic navigation sensor into the target sampling tissue (target target point), and then the operator controls the trigger assembly 5 to move from the initial position to the trigger position, and under the drive of the trigger assembly 5, the firing assembly 6 switches from the energy storage state to the firing state. In this process, the biopsy needle assembly 1 extends outward toward the far end of the shell to perform biopsy sampling. When the biopsy needle assembly 1 has not reached the target sampling position in the tissue, the locking assembly on the fully automatic biopsy needle is in the locked position, and the locking assembly includes a locking piece 19, which is rotatably mounted on the proximal side of the shell, wherein the rotation direction of the locking piece 19 is the circumferential direction of the shell, and the locking piece 19 can be inserted between the trigger assembly 5 and the firing assembly 6 when rotating in the axial direction of the shell, and a fixed support disk 20 is formed in the shell for abutting the locking piece 19 in the locked position. When locking the fully automatic biopsy needle, the locking piece 19 is rotated from the unlocked position to the locked position. At this time, even if an accidental touch occurs, so that the trigger assembly 5 moves from the initial position to the trigger position, the locking piece 19 will be squeezed onto the fixed support disk 20, and the trigger assembly 5 will not reach the trigger position, and thus the trigger assembly 5 will not change the state of the firing assembly 6.

[0070] The locking assembly is arranged between the trigger assembly 5 and the firing assembly 6 to block the trigger assembly 5 from moving to the trigger position. On the one hand, it can avoid setting the locking assembly on the firing path of the firing assembly 6. When the firing assembly 6 is fired, the firing assembly 6 has switched from the energy storage state to the firing state. The locking assembly blocks the firing assembly 6 from firing on the path of the firing assembly 6. The firing assembly 6 will always maintain the firing state. The spring elastic force is large, and the locking assembly is easily invalidated under the long-term elastic force compression; on the other hand, the locking assembly is arranged between the trigger assembly 5 and the firing assembly 6. When an accidental touch occurs, the trigger assembly 5 squeezes the locking piece 19 so that the locking piece 19 abuts against the fixed support plate 20, so that the trigger assembly 5 cannot move to the trigger position, and the firing assembly 6 still maintains the energy storage state. The locking piece 19 hardly deforms and has a high strength; at the same time, the locking piece 19 can form a reasonable distribution with the biopsy needle assembly 1 and the first electromagnetic navigation sensor 11, and no interference will occur in the shell, and there is no need to open a through hole in the shell to destroy the strength of the shell.

[0071] In this embodiment, the locking assembly further includes a locking key 21 mounted on the housing, the locking key 21 is fixedly connected to the locking member 19 or is an integral structure, a waist-shaped hole extending along the axial direction of the housing is provided on the housing, the locking key 21 is rotatably mounted in the waist-shaped hole, and the locking key 21 can drive the locking member 19 to switch between the unlocking position and the locking position when moving in the waist-shaped hole. In this embodiment, the locking key 21 and the locking member 19 are preferably an integrally formed structure.

[0072] In this embodiment, the trigger assembly 5 includes a rear trigger key 3 and a trigger link 15. The rear trigger key 3 can be pressed and installed on the proximal end face of the shell. The trigger link 15 is installed in the shell and is located on the distal side of the rear trigger key 3. When the operator presses the rear trigger key 3, the rear trigger key 3 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, the firing assembly 6 is triggered. The firing assembly 6 switches from the energy storage state to the firing state, driving the biopsy needle assembly 1 to extend outward from the distal end of the shell for biopsy sampling. Among them, the rear trigger key 3 and the connecting through hole 12 are arranged side by side on the proximal end face of the shell. On the one hand, the first electromagnetic navigation sensor needs to pass through the shell and extend into the distal target position of the sensor assembly channel 1013, and a hole needs to be opened on the shell; on the other hand, the rear trigger key 3 can be tilted and set on the proximal end face of the shell, and the rear trigger key 3 is at least partially exposed on the outside of the shell to facilitate the operator to press. Since the rear trigger key 3 and the connecting through hole 12 are arranged side by side on the end face of the proximal end of the shell, it would be inconvenient to process the rear trigger key 3 if it were an integrally formed structure with the trigger link 15. Therefore, the rear trigger key 3 and the trigger link 15 are designed to be separated and demolded separately, which reduces the difficulty of overall demolding and facilitates the processing of the rear trigger key 3 and the trigger link 15.

[0073] Furthermore, when the locking piece 19 moves to the locking position, when the operator presses the rear trigger key 3, the trigger link 15 squeezes the proximal surface of the locking piece 19, and the distal surface of the locking piece 19 abuts against the fixed support disk 20. The locking piece 19 is stuck between the trigger link 15 and the fixed support disk 20, blocking the trigger link 15 from moving to the trigger position, so that before being unlocked, the biopsy needle assembly 1 in the full-automatic biopsy needle will not pop out for sampling, ensuring that the biopsy needle assembly 1 reaches the target position before biopsy sampling, thereby ensuring the accuracy of the sampling result.

[0074] Furthermore, the end face of the insertion end of the locking piece 19 used to be inserted between the trigger assembly 5 and the firing assembly 6 is formed with an avoidance slope 191 for cooperating with the trigger link 15. After the fully automatic biopsy needle is fired multiple times, the automatic return function of the trigger link 15 may be reduced, making it impossible for the trigger link 15 to accurately return to the initial position. At this time, when the locking piece 19 is rotated and inserted between the trigger link 15 and the firing assembly 6, it is easily blocked by the trigger link 15 that has not returned to the initial position, making it impossible for the locking piece 19 to move to the locked position. The design of the avoidance slope 191 can make a certain size, so that when the locking piece 19 moves to the locked position, the end of the trigger link 15 first contacts the avoidance slope 191. With the assistance of the avoidance slope 191, the trigger link 15 can be pushed toward the initial position, so that the locking piece 19 can be completely moved to the locked position through the avoidance slope 191, so as to better lock the fully automatic biopsy needle.

[0075] 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.

[0076] Furthermore, the fixed support disk 20 is the cavity wall on the distal side of the trigger assembly mounting cavity, and a first clamping hole 16 for the firing assembly 6 to extend out and be clamped at the protruding end of the firing assembly 6 is formed in the middle of the fixed support disk 20. The firing assembly 6 extends from the first clamping hole 16 when in the energy storage state. When the protruding end of the firing assembly 6 is clamped in the first clamping hole 16, the firing assembly 6 maintains the energy storage state. When the trigger link 15 in the trigger assembly 5 moves to the trigger position, the protruding end of the firing assembly 6 can be disengaged from the first clamping hole 16, so that the firing assembly 6 switches from the energy storage state to the firing state.

[0077] 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 deform and store energy. After the rear trigger key 3 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 rear trigger key 3 and the trigger link 15 can automatically return to their positions. Furthermore, after the fully-automatic biopsy needle has been fired multiple times, the elastic wing 52 may produce elastic fatigue, making it impossible for the trigger link 15 and the rear trigger key 3 to return to their initial positions. At this time, when the locking piece 19 is rotated and inserted between the trigger link 15 and the firing assembly 6, it is easily blocked by the trigger link 15 that has not returned to its initial position, making it impossible for the locking piece 19 to move to the locked position. The design of the avoidance slope 191 allows a certain size to be left, so that when the locking piece 19 moves to the locked position, the end of the trigger link 15 first contacts the avoidance slope 191. With the assistance of the avoidance slope 191, the trigger link 15 can be pushed toward the initial position, so that the locking piece 19 can be completely moved to the locked position through the avoidance slope 191, thereby better locking the fully-automatic biopsy needle.

[0078] In this embodiment, the firing assembly 6 and the trigger assembly 5 are arranged in the shell, 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, and 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, and the firing assembly 6 drives the needle core 101 and the needle tube 102 to extend outward toward the distal direction of the shell 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.

[0079] Furthermore, the trigger assembly 5 also includes a third slider 51 formed on the trigger link 15, and elastic wings 52 extend from both sides of the third slider 51. When the operator presses the trigger button, the rear trigger button drives the third slider 51 to slide from the initial position to the trigger position, so as to drive the firing assembly 6 to switch from the energy storage state to the firing state.

[0080] In this embodiment, Figure 8 , Fig. 9 and Fig.10As shown, the firing assembly 6 includes a first sub-firing assembly 61 and a second sub-firing assembly 62, the firing assembly mounting cavity includes a first cavity and a second cavity, the first sub-firing assembly 61 is installed in the first cavity, 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, 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.

[0081] 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.

[0082] Specifically, the first end of the first slider 611 has a first clamping portion, and the first cavity has a first clamping hole 16 that cooperates with the first clamping portion. When the first clamping portion is clamped into the first clamping hole 16, the first slider 611 enters an energy storage state. When the first clamping portion is separated from the first clamping hole 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 hole 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 hole 17 that cooperates with the second clamping portion. When the second clamping portion is clamped into the second clamping hole 17, the second slider 621 enters an energy storage state. When the second clamping portion is disengaged from the second clamping hole 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 hole 17, so that the second clamping portion is disengaged from the second clamping hole 17, and the second slider 621 enters a firing state, driving the needle tube 102 to pop out.

[0083] 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 clamping hole 16 and is clamped on the side of the first clamping hole 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 clamping hole 16, and the first slider 611 enters a firing state, driving the needle core 101 to extend outward toward the distal end of the shell; a second elastic block 6211 is formed at the first end of the second slider 621, and the second The elastic block 6211 passes through the second clamping hole 17 and is clamped on the side of the second clamping hole 17 to keep the second slider 621 in the 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 make the second elastic block 6211 disengage from the second clamping hole 17, and the second slider 621 enters the firing state, driving the needle tube 102 to extend toward the distal end of the shell. When the needle core 101 and the needle tube 102 extend toward the distal end of the shell, the biopsy sampling of the target position is completed.

[0084] In this embodiment, the outer diameter of the end of the first elastic block 6111 away from the trigger assembly 5 is larger than the outer diameter of the end of the first elastic block 6111 close to the trigger assembly 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 hole 16, and the first elastic block 6111 is radially offset inward, so that the first elastic block 6111 can enter the first hole 16 and pass through the first hole 16. After the first elastic block 6111 passes through the first hole 16, there is no squeezing of the side wall of the first hole 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 hole 16, preventing the first elastic block 6111 from sliding out of the first hole 16, so that the first slider 611 maintains the energy storage state.

[0085] 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 hole 17, and the second elastic block 6211 is radially offset inward, so that the second elastic block 6211 can enter the second hole 17 and pass through the second hole 17. After the second elastic block 6211 passes through the second hole 17, it is no longer squeezed by the side wall of the second hole 17, and 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 hole 17, preventing the second elastic block 6211 from sliding out of the second hole 17, so that the second slider 621 maintains the energy storage state.

[0086] 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.

[0087] 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.

[0088] In this embodiment, 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 clamping hole 16, so that when the first slider 611 slides, the first inclined surface 6112 partially enters the first clamping hole 16 first, and as the first inclined surface 6112 gradually enters, the inner wall of the first clamping hole 16 begins to squeeze the first The inclined surface 6112 causes the first elastic block 6111 to contract radially inward and eventually completely enter the first hole 16. After passing through the first hole 16, the first elastic block 6111 expands radially outward under the action of its own elastic force and recovers its deformation because there is no restriction from the inner wall of the first hole 16. At this time, the radial dimension of the end of the first elastic block 6111 facing the first hole 16 is greater than the inner diameter of the first hole 16, thereby preventing the first elastic block 6111 from detaching from the first hole 16 and keeping the first slider 611 in an energy storage state.

[0089] 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 clamping hole 16, so that the first elastic block 6111 can break away from the restriction of the first clamping hole 16 and enter the first clamping hole 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 shell.

[0090] 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 clamping hole 17, so that when the second slider 621 slides, the third inclined surface 6212 partially enters the second clamping hole 17 first, and as the third inclined surface 6212 gradually enters, the inner wall of the second clamping hole 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 clamping hole 17. After passing through the second clamping hole 17, due to the lack of restriction from the inner wall of the second clamping hole 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 clamping hole 17 is greater than the inner diameter of the second clamping hole 17, thereby preventing the second elastic block 6211 from detaching from the second clamping hole 17 and keeping the second slider 621 in an energy storage state.

[0091] 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 extrusion 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 card hole 17, so that the second elastic block 6211 can break away from the restriction of the second card hole 17 and enter the second card hole 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 distal end of the shell.

[0092] In this embodiment, a fixed protective tube 14 is further provided in the shell, and the fixed protective tube 14 is aligned with the sensor assembly channel 1013. The first electromagnetic navigation sensor 11 is guided by the fixed protective tube 14 and extends into the sensor assembly channel 1013. The fixed protective tube 14 passes through the elastic wing 52. The elastic wing 52 is formed with an avoidance hole through which the fixed protective tube 14 passes and avoids interference with the fixed protective tube 14 when the trigger link 15 moves. The fixed protective tube 14 passes through the avoidance hole corresponding to the needle body 1011. The diameter of the avoidance hole is slightly larger than the outer diameter of the fixed protective tube 14, so that when the trigger link 15 slides, the avoidance hole drives the elastic wing 52 to deform, and the avoidance hole can move slightly on the fixed protective tube 14, thereby avoiding the avoidance hole of the elastic wing 52 being tightly mounted on the fixed protective tube 14 and unable to move, thereby affecting the sliding of the trigger link 15.

[0093] In this embodiment, the needle tube 102 is used to cooperate with the sampling groove 1014 on the needle tip 1012 to complete sampling.

[0094] 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.

[0095] In this embodiment, the needle tip 1012 and the needle body 1011 are separately provided, 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 between the cylinder and the blind hole to make the connection between the needle tip 1012 and the needle body 1011 more firmly.

[0096] 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.

[0097] 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.

[0098] In this embodiment, it also includes a side trigger key 4, and the side trigger key 4 and the rear trigger key 3 are respectively arranged on the side and the tail end of the handle formed by the shell, and the side trigger key 4 and the rear trigger key 3 are connected by a trigger link 15, and 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, and 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, 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.

[0099] 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. The first push button 10 and the second push button 9 are at least partially exposed on the outside of the shell, wherein 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 to the energy storage state, and by pressing the second push button 9, the operator can control the second slider 621 to retract and move into the shell to the energy storage state. Example 2

[0100] This embodiment provides a specific implementation of a biopsy system based on electromagnetic positioning, including the fully automatic biopsy needle of Example 1, a second electromagnetic navigation sensor and a navigation device. When in use, the second electromagnetic navigation sensor is fixed on an ultrasonic probe, and the ultrasonic probe can be a surface probe or an intraoperative probe, without limitation. The navigation device is configured to extract electromagnetic signals from 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 ultrasonic probe based on the electromagnetic signals.

[0101] 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 based on electromagnetic positioning, characterized in that: include: Shell, firing assembly, trigger assembly, biopsy needle assembly, first electromagnetic navigation sensor, fixed protection tube; The firing assembly, the trigger assembly, the biopsy needle assembly, the first electromagnetic navigation sensor, and the fixed protection tube are assembled on the housing; A hollow sensor assembly channel is formed inside the biopsy needle assembly, and the sensor assembly channel extends along the length direction of the biopsy needle assembly; 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 performs biopsy sampling; The trigger assembly is used to trigger the firing assembly; A connecting through hole is opened at the proximal end of the housing, and the fixed protection tube is fixedly arranged inside the proximal end of the housing and aligned with the center of the connecting through hole at the proximal end side and the sensor assembly channel at the distal end side; The first electromagnetic navigation sensor is an elongated structure, the distal end of which is suitable for passing through the connecting through hole and the fixed protection tube to extend into the target position at the distal end of the sensor assembly channel, and the proximal end of which is suitable for connecting to the navigation device; The biopsy needle assembly includes a needle core and a needle tube that are slidably connected. 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. The sensor assembly channel is formed inside the needle body. The proximal end of the needle core extends into the fixed protective tube. 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.

2. The fully automatic biopsy needle based on electromagnetic positioning according to claim 1, characterized in that: The axial proximal side of the connecting through hole is used to install the first connecting piece, and a channel is formed in the middle of the first connecting piece. The distal end of the first electromagnetic navigation sensor is suitable for passing through the channel of the first connecting piece and through the fixed protective tube to be inserted into the target position of the sensor assembly channel of the needle body. The first connecting piece and the first electromagnetic navigation sensor are relatively fixedly arranged.

3. The fully automatic biopsy needle based on electromagnetic positioning according to claim 2, characterized in that: The connection between the distal end of 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.

4. The fully automatic biopsy needle based on electromagnetic positioning according to claim 3, 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. A positioning protrusion or an annular groove is provided on the side wall of the connecting cap, and an annular groove or a positioning 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 positioning protrusion and the annular groove.

5. The fully automatic biopsy needle based on electromagnetic positioning according to any one of claims 1 to 4, characterized in that: The housing comprises an outer shell and an inner shell, the outer shell is sleeved on the outer side of the inner shell, the inner shell comprises a firing assembly installation cavity at the distal end and a trigger assembly installation cavity at the proximal end, and a biopsy needle assembly installation cavity located on one side of the firing assembly installation cavity and the trigger assembly installation cavity, the firing assembly, the trigger assembly and the biopsy needle assembly are respectively assembled in the firing assembly installation cavity, the trigger assembly installation cavity and the biopsy needle assembly installation cavity; The connecting through hole is formed on the proximal surface of the shell and communicates with the trigger assembly installation cavity. The proximal end of the fixed protection tube is fixed to the shell and communicates with the connecting through hole. The distal end of the fixed protection tube passes through the trigger assembly and extends to the biopsy needle assembly installation cavity.

6. The fully automatic biopsy needle based on electromagnetic positioning according to claim 5, characterized in that: The trigger assembly has an initial position and a trigger position for moving along a trigger path toward the distal end of the housing to trigger the firing assembly to switch from the energy storage state to the firing state; The trigger assembly comprises a rear trigger key and a trigger connecting rod, wherein the rear trigger key and the trigger connecting rod are both slidably mounted in the housing, and the rear trigger key and the trigger connecting rod switch between the initial position and the trigger position during the sliding process; The trigger link has a pair of elastic wings extending to both sides, and a retaining wall for resisting the elastic wings is formed in the trigger component mounting cavity. When the trigger link moves from the initial position to the trigger position, the retaining wall resists the elastic wings to deform and store energy. After the rear trigger key releases the drive on the trigger link, the trigger link drives the rear trigger key to automatically move from the trigger position to the initial position under the deformation recovery action of the elastic wings.

7. The fully automatic biopsy needle based on electromagnetic positioning according to claim 6, characterized in that: The elastic wing is provided with an avoidance hole for the fixed protection tube to pass through, and the avoidance hole is arranged so that the elastic wing does not interfere with the fixed protection tube when the elastic wing moves with the trigger connecting rod.

8. The fully automatic biopsy needle based on electromagnetic positioning according to claim 6, characterized in that: The rear trigger key and the connecting through hole are arranged side by side on the end surface of the proximal end of the shell, and the rear trigger key and the trigger connecting rod are arranged separately.

9. The fully automatic biopsy needle based on electromagnetic positioning according to claim 8, characterized in that: The rear trigger key is arranged obliquely on the end surface of the proximal end of the shell, and the rear trigger key is at least partially exposed outside the shell.

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