Fully automatic biopsy needle and 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 belong to the technical field of medical instruments. Specifically, the fully automatic biopsy needle comprises: a housing, a firing assembly, a trigger assembly, a biopsy needle assembly, and a first electromagnetic navigation sensor. The biopsy needle assembly comprises a stylet and a cannula. The stylet comprises a needle body and a needle tip. A sensor assembly channel is disposed in the needle body, and the first electromagnetic navigation sensor extends to a position close to the needle tip in the sensor assembly channel. When the biopsy needle is inserted into a human body, a surgeon can use a navigation device to identify a spatial position of the first electromagnetic navigation sensor in the human body, and then use the dimensional relationship between the first electromagnetic navigation sensor and the needle tip as well as a sampling groove in the biopsy needle assembly to accurately calculate spatial positions of the needle tip and the sampling groove in the human body, so that the positional relationship between the needle tip and the sampling groove in the biopsy needle assembly and a target position can be determined, thereby enabling accurate sampling at the target position.

Description

A fully automated biopsy needle and an electromagnetic positioning-based biopsy system Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a fully automated biopsy needle and an electromagnetic positioning-based biopsy system. Background Technology

[0002] A fully automated biopsy needle is an advanced medical device used to obtain tissue samples for pathological testing. Compared with traditional manual biopsy methods, the fully automated biopsy needle automates the firing and sampling processes, improving the efficiency and accuracy of biopsies.

[0003] Currently, in clinical biopsy procedures, fully automated biopsy needles are typically used in conjunction with image-guided technology, including X-ray fluoroscopy, ultrasound, CT, and MRI. During the preoperative preparation phase, the surgeon first uses various imaging techniques (such as ultrasound, CT, or MRI) to image the patient to obtain detailed information about the target lesion, including its location, size, and shape. Then, based on the image data, a detailed sampling plan is developed, determining the puncture point, insertion path, angle, and depth of the biopsy needle. During the procedure, the fully automated biopsy needle is operated according to this information to perform the sampling operation.

[0004] However, during the actual procedure, the surgeon can only determine the puncture point on the patient's body surface. The exact location of the biopsy needle after it enters the body and its distance from the target sampling location cannot be accurately determined. Only the approximate location can be judged for sampling, which may affect the sampling results. Summary of the Invention

[0005] The purpose of this application is to provide a fully automated biopsy needle, which aims to solve the problem in related technologies where the specific location of the biopsy needle after entering the human body and its distance from the target sampling location cannot be accurately determined, which may affect the sampling results.

[0006] Additional aspects and advantages of this 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 this application.

[0007] According to a first aspect of this application, a fully automated biopsy needle is provided, comprising:

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

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

[0010] The firing assembly is connected to the biopsy needle assembly. The firing assembly has an energy storage state in which it drives the biopsy needle assembly to retract inward toward the proximal end of the housing, and a firing state in which it drives the biopsy needle assembly to extend outward toward the distal end of the housing under the triggering of the triggering assembly. During the switching process from the energy storage state to the firing state, the biopsy needle assembly completes biopsy sampling.

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

[0012] The biopsy needle assembly includes a needle core and a needle tube that are sleeved together. The needle core includes a needle tip located at the distal end and a needle body that connects to the proximal end of the needle tip and extends towards 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 of the needle body.

[0013] The first electromagnetic navigation sensor has 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 remains stationary.

[0014] In an exemplary embodiment of this application, a connection through hole is provided at the proximal end of the housing, which communicates with the sensor assembly channel. A first connector is installed on the connection through hole. A connector cap is provided at the distal end of the first connector. The connector cap is inserted into the connection through hole. An annular protrusion or an annular groove is provided on the side wall of the connector cap. An annular groove or an annular protrusion is provided on the inner wall of the connection through hole. The connector cap is rotatably connected to the connection through hole through the cooperation of the annular protrusion and the annular groove. The distal end of the first electromagnetic navigation sensor extends through the first connector to the target position of the sensor assembly channel. The proximal end of the first electromagnetic navigation sensor is adapted to be connected to a navigation device. The first electromagnetic navigation sensor and the first connector are fixedly disposed relative to each other.

[0015] The first electromagnetic navigation sensor has a second connector sleeved on its proximal end, and the distal end of the first electromagnetic navigation sensor extends through the distal end of the second connector. The first electromagnetic navigation sensor and the second connector are fixedly installed, and the distal end of the second connector is detachably connected to the proximal end of the first connector. When the distal end of the second connector is connected to the proximal end of the first connector, the distal end of the first electromagnetic navigation sensor extends into the target position of the sensor assembly channel.

[0016] In one exemplary embodiment of this application, a fixed protective tube is provided inside the proximal end of the housing. The fixed protective tube, the connecting through hole, and the sensor assembly channel are aligned at their centers. The distal end of the elongated first electromagnetic navigation sensor extends through the connecting through hole and the fixed protective tube into the target position of the sensor assembly channel, and its proximal end is adapted to connect to a navigation device.

[0017] The length of the needle core extending into the fixed protective tube is set such that the needle core will not come 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 switches to the energy storage state with the firing assembly.

[0018] In one exemplary embodiment of this application, the housing includes an outer shell and an inner shell, the outer shell being sleeved on the outside of the inner shell, the inner shell including a firing assembly mounting cavity on the distal side and a trigger assembly mounting cavity on the proximal side, and a biopsy needle assembly mounting cavity located on one side of the firing assembly mounting cavity and the trigger assembly mounting cavity, the firing assembly, the trigger assembly, and the biopsy needle assembly being respectively assembled in the firing assembly mounting cavity, the trigger assembly mounting cavity, and the biopsy needle assembly mounting cavity;

[0019] The connecting through hole is opened on the proximal end face of the housing and communicates with the trigger assembly mounting cavity. The proximal end of the fixing protective tube is fixed to the housing and communicates with the connecting through hole. The distal end of the fixing protective tube extends through the trigger assembly into the biopsy needle assembly mounting cavity.

[0020] In one exemplary embodiment of this application, the triggering component includes a rear trigger key and a trigger link, the rear trigger key and the trigger link having an initial position and a trigger position for moving along a trigger path toward the distal end of the housing to trigger the firing component to switch from the energy storage state to the firing state, the rear trigger key and the trigger link switching between the initial position and the trigger position during the movement;

[0021] The trigger link has a pair of elastic wings extending to both sides. The trigger assembly mounting cavity has a baffle wall formed to resist the elastic wings. When the trigger link moves from the initial position to the trigger position, the baffle wall resists the elastic wings to deform and store energy. After the rear trigger key releases the drive of 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.

[0022] The elastic wing has a clearance hole for the fixed protective tube to pass through, and the clearance hole is configured so that the elastic wing does not interfere with the fixed protective tube when it moves with the trigger linkage.

[0023] In one exemplary embodiment of this application, a locking component is further included. The component includes a locking member and a locking key. The locking member is rotatably mounted on the proximal side of the housing. The locking member has an unlocked position and a locked position that is rotatably inserted between the triggering component and the firing component in the circumferential direction of the housing. In the locked position, the locking member prevents the triggering component from moving to the triggering position. A fixed support plate is formed inside the housing. The fixed support plate is configured to abut against the distal end face of the locking member when the locking member is rotated to the locked position. The proximal end face of the locking member abuts against the trigger linkage.

[0024] The locking key is assembled on the housing. The locking key is fixedly connected to the locking member or is an integral structure. The housing has an oblong hole extending circumferentially. The locking key is rotatably mounted in the oblong hole along the circumferential direction of the housing and drives the locking member to switch between the unlocked position and the locked position.

[0025] In one exemplary embodiment of this application, the end face of the locking member for insertion between the trigger assembly and the firing assembly is formed with a clearance slope for cooperating with the trigger linkage.

[0026] In one exemplary embodiment of this application, the rear trigger key and the connecting through hole are distributed side by side on the end face of the near end of the housing, the rear trigger key is inclinedly disposed on the end face of the near end of the housing, and the rear trigger key is at least partially exposed on the outside of the housing, and the rear trigger key and the trigger link are separately disposed;

[0027] The triggering component also includes a side triggering key, which is fixedly connected to the triggering link. The side triggering key switches between an initial position and a triggering position as it slides along the triggering link.

[0028] The side trigger key is located on the side of the housing, and the rear trigger key is located at the proximal end of the housing.

[0029] In one exemplary embodiment of this application, the needle tip and the needle body are separately disposed, and the proximal end of the needle tip and the distal end of the needle body are connected by adhesive or welding.

[0030] In one exemplary embodiment of this application, the firing assembly includes a first sub-firing assembly disposed at a proximal end and a second sub-firing assembly disposed at a distal end. The first sub-firing assembly includes a first slider and a first elastic element, and the second sub-firing assembly includes a second slider and a second elastic element.

[0031] The firing assembly mounting cavity within the housing has a first cavity located proximally and a second cavity located distally. A first slider and a first elastic element are mounted in the first cavity, while a second slider and a second elastic element are mounted in the second cavity. The needle core is fixed to the first slider, which is slidably mounted within the first cavity. The first slider has a stored energy state within the first cavity, compressing the first elastic element to retract the needle core. It also has a firing state within the first cavity, ejecting the needle core. The needle tube is fixed to the second slider, which is slidably mounted within the second cavity. The second slider has a stored energy state within the second cavity, compressing the second elastic element to retract the needle tube. It also has a firing state within the second cavity, ejecting the needle tube. The first slider, triggered by the triggering component, switches from the stored energy state to the firing state, simultaneously ejecting the needle core distally. When the first slider switches to the firing state, it triggers the second slider to switch from the stored energy state to the firing state, simultaneously ejecting the needle tube distally.

[0032] A second aspect of this application provides a biopsy system based on electromagnetic positioning, including the fully automated biopsy needle, a second electromagnetic navigation sensor, and a navigation device as described above;

[0033] The second electromagnetic navigation sensor is fixedly connected to the ultrasonic probe;

[0034] The navigation device is configured to extract the electromagnetic signals received by the first electromagnetic navigation sensor and the second electromagnetic navigation sensor, and determine the spatial positional relationship between the fully automated biopsy needle and the ultrasound probe based on the electromagnetic signals.

[0035] The exemplary embodiments of this application may have some or all of the following beneficial effects:

[0036] The fully automated biopsy needle provided in the example embodiment of this application includes a housing, a firing assembly, a triggering assembly, a biopsy needle assembly, and a first electromagnetic navigation sensor. The housing forms a handle for the operator to hold and operate. The firing assembly, triggering assembly, biopsy needle assembly, and first electromagnetic navigation sensor are all assembled within the handle formed by the housing. The firing assembly is connected to the biopsy needle assembly. The firing assembly has a stored energy state that drives the biopsy needle assembly to retract inward toward the proximal end of the housing. The firing assembly also has a firing state that, when triggered by the triggering assembly, drives the biopsy needle assembly to extend outward toward the distal end of the housing. The firing assembly drives the biopsy needle assembly in the stored energy state. During the transition from the firing state to the ignition 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 located at the distal end and a needle body extending from the proximal end of the needle tip towards 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 of the needle body. The first electromagnetic navigation sensor has 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 distal 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 remains stationary.

[0037] On the one hand, by coordinating the triggering component, firing component and biopsy needle component, the fully automated biopsy needle can be launched and sampled, which improves efficiency and accuracy compared to manual biopsy needle launch and sampling;

[0038] On the other hand, the fully automated biopsy needle is combined with the first electromagnetic navigation sensor. By forming a hollow sensor assembly channel inside the needle core of the biopsy needle assembly, the slender first electromagnetic navigation sensor can be inserted from the proximal opening of the needle body to the distal target position of the needle body during biopsy. When the biopsy needle is inserted into the human body, the operator can use the navigation device to identify the spatial position (position and orientation) of the first electromagnetic navigation sensor in the human body. Then, by using the size relationship between the first electromagnetic navigation sensor and the needle tip and sampling groove in the biopsy needle assembly, the operator can accurately calculate the spatial position (position and orientation) of the needle tip and sampling groove in the human body, thereby determining the positional relationship between the needle tip and sampling groove of the biopsy needle assembly and the target sampling position.

[0039] On the other hand, since the needle core has a certain firing distance when fired, if the first electromagnetic navigation sensor is fixed inside the needle core and ejected towards the distal end along with the needle core during firing, a fixing structure for fixing the first electromagnetic navigation sensor needs to be designed inside the needle core during production. This is difficult to achieve in the narrow sensor assembly channel. In addition, when the biopsy needle needs to perform secondary or multiple sampling, the needle core needs to return to the energy storage state along with the firing assembly. If the first electromagnetic navigation sensor is fixed inside the needle core, it will retract towards the proximal end along with the needle core. The slender first electromagnetic navigation sensor will be squeezed or bent in the sensor assembly channel, which can easily cause damage to the first electromagnetic navigation sensor and is not conducive to its service life. Moreover, if the fixing structure is not secure, it will also cause the relative position of the first electromagnetic navigation sensor and the needle core to change, resulting in inaccurate positioning of the spatial position of the needle tip and sampling slot by the navigation device during secondary (or multiple) sampling, thus causing secondary (or multiple) sampling failure. Therefore, to facilitate the production of the needle core and the assembly of the first electromagnetic navigation sensor, and to avoid secondary (or multiple) sampling failures caused by changes in the relative position of the first electromagnetic navigation sensor and the needle core during use, in the fully automated biopsy needle provided in the example embodiment of this application, the first electromagnetic navigation sensor and the needle core are not fixed together when assembled into the sensor assembly channel of the needle body. Furthermore, there is no need to design a fixing structure inside the sensor assembly channel to fix the first electromagnetic navigation sensor. In actual use, the biopsy needle assembly is first adjusted to an energy storage state, and then the first electromagnetic navigation sensor is extended along the sensor assembly channel of the needle body towards the sensor core. After assembling the first electromagnetic navigation sensor at the target position at the far end of the assembly channel, the biopsy needle assembly in a stored-energy state is finally inserted into the human body for firing and sampling. The spatial position (position and orientation) of the needle tip (and its sampling slot) in the biopsy needle assembly is determined by the first electromagnetic navigation sensor. When the firing component switches the biopsy needle assembly from the stored-energy state to the firing state, the first electromagnetic navigation sensor remains stationary. The specific spatial position of the needle tip (and its sampling slot) after firing can be calculated from the spatial position of the first electromagnetic navigation sensor and the dimensional relationship between the target position of the sensor assembly channel and the needle tip (and its sampling slot). This setup not only enables intraoperative positioning of the needle tip (and its sampling slot), but also has a simple structure, is easy to manufacture, and the first electromagnetic navigation sensor is not easily damaged.

[0040] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0041] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application. It is obvious that the drawings described below are merely some embodiments of this application, and those skilled in the art can obtain other drawings based on these drawings without any inventive effort.

[0042] Figure 1 shows a schematic diagram of a fully automated biopsy needle according to Embodiment 1 of this application;

[0043] Figure 2 shows a partial exploded view of a fully automated biopsy needle according to Embodiment 1 of this application;

[0044] Figure 3 shows an exploded view of the needle core in the biopsy needle assembly of Embodiment 1 of this application;

[0045] Figure 4 shows a cross-sectional view of the firing assembly in the energy storage state in Embodiment 1 of this application;

[0046] Figure 5 shows an enlarged schematic diagram of point A in Figure 4;

[0047] Figure 6 shows an enlarged schematic diagram of the area without the locking key at point A in Figure 4;

[0048] Figure 7 shows an exploded view of a fully automated biopsy needle according to Embodiment 1 of this application;

[0049] Figure 8 shows a schematic diagram of the connection between the first connecting tube, the connecting cap and the electromagnetic navigation sensor in an embodiment of this application;

[0050] Figure 9 shows an enlarged schematic diagram of point B in Figure 8;

[0051] Figure 10 shows a schematic diagram of the firing assembly in the firing state in Embodiment 1 of this application;

[0052] Figure 11 shows a cross-sectional view of the firing assembly in the firing state in Embodiment 1 of this application;

[0053] Figure 12 shows a schematic diagram of the firing assembly in Embodiment 1 of this application.

[0054] Explanation of reference numerals in the attached drawings: 1. Biopsy needle assembly; 101. Needle core; 1011. Needle body; 1012. Needle tip; 1013. Sensor assembly channel; 1014. Sampling slot; 102. Needle tube; 2. Housing; 3. Rear trigger button; 4. Side trigger button; 5. Trigger assembly; 51. Third slider; 511. Second inclined surface; 52. Elastic fin; 6. Firing assembly; 61. First sub-firing assembly; 611. First slider; 6111. First elastic locking block; 6112. First inclined surface; 612. First elastic element; 62. Second sub-firing assembly; 621. Second slider; 6211. Second elastic locking block; 6212. Third inclined surface; 622. Second elastic element; 7. First inner shell; 8. Second inner shell; 9. Second press button; 10. First press button; 11. First electromagnetic navigation sensor; 12. Connecting through hole; 13. Connecting cap; 14. Fixing protective tube; 15. Trigger linkage; 16. First slot; 17. Second slot; 18. Fourth inclined surface; 19. Locking element; 191. Avoidance inclined surface; 20. Fixing support plate; 21. Locking button; 22. First connecting tube; 23. Annular protrusion. Detailed Implementation

[0055] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this application will be thorough and complete, and will fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore their detailed descriptions will be omitted. Furthermore, the drawings are merely illustrative of this application and are not necessarily drawn to scale.

[0056] Although relative terms such as "upper" and "lower" are used in this specification to describe the relative relationship of one component of an icon to another, these terms are used only for convenience, such as according to the orientation of the examples in the accompanying drawings. It is understood that if the device of the icon is flipped so that it is upside down, the component described as "upper" will become the component described as "lower." When a structure is "upper" of another structure, it may mean that the structure is integrally formed on the other structure, or that the structure is "directly" mounted on the other structure, or that the structure is "indirectly" mounted on the other structure through another structure.

[0057] The terms “a,” “one,” “the,” and “at least one” are used to indicate the existence of one or more elements / components / etc.; the terms “including” and “having” are used to indicate an open-ended inclusion and to mean that there may be other elements / components / etc. in addition to the listed elements / components / etc.; the terms “first” and “second” are used only as markers and are not a limitation on the number of objects.

[0058] The term "proximal" refers to the end closer to the surgeon, while "distal" refers to the end farther from the surgeon.

[0059] Example 1

[0060] This embodiment provides a specific implementation of a fully automated biopsy needle, as shown in Figures 1, 2, and 3. It includes a housing, a firing assembly 6, a trigger assembly 5, a biopsy needle assembly 1, and a first electromagnetic navigation sensor 11. The housing forms a handle for the operator to hold and operate. The firing assembly 6, trigger assembly 5, biopsy needle assembly 1, and first electromagnetic navigation sensor 11 are all assembled within the handle formed by the housing. The firing assembly 6 is connected to the biopsy needle assembly 1. The firing assembly 6 has a stored energy state that retracts the biopsy needle assembly 1 towards the proximal end of the housing. The firing assembly 6 also has a firing state that extends the biopsy needle assembly 1 towards the distal end of the housing when triggered by the trigger assembly 5. During the switching from the stored energy state to the firing state, the biopsy needle assembly 1 completes the biopsy sampling. The biopsy needle assembly 1 includes a needle core 101 and a needle tube 102. The core 101 includes a needle body 1011 and a needle tip 1012. A sensor mounting channel 1013 extending along the length of the needle body 1011 is formed inside the needle body 1011. A first electromagnetic navigation sensor 11 can extend into the sensor mounting channel 1013 through the proximal opening of the needle body 1011. This allows the elongated first electromagnetic navigation sensor 11 to be inserted from the proximal opening of the needle body 1011 to the distal target position of the needle body 1011, near the needle tip 1012, during a biopsy. Thus, when the biopsy needle is inserted into the human body, the operator can use a navigation device to identify the spatial position of the first electromagnetic navigation sensor 11 within the body. Furthermore, by utilizing the dimensional relationship between the first electromagnetic navigation sensor 11 and the needle tip 1012 and sampling groove 1014 in the biopsy needle assembly 1, the operator can accurately calculate the spatial positions of the needle tip 1012 and sampling groove 1014 within the human body. It should be noted that, in this document, spatial position includes both position and orientation.

[0061] In this embodiment, on the one hand, by cooperating with the triggering component 5, the firing component 6 and the biopsy needle component 1, the automatic firing and sampling of the fully automatic biopsy needle is realized, which improves efficiency and accuracy compared with the manual firing and sampling of the biopsy needle.

[0062] On the other hand, the fully automated 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, 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 during the biopsy procedure. 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 orientation) of the first electromagnetic navigation sensor 11 in the human body. Then, by using the size relationship between the first electromagnetic navigation sensor 11 and the needle tip 1012 and the sampling groove 1014 in the biopsy needle assembly 1, the spatial position (position and orientation) of the needle tip 1012 and the sampling groove 1014 in the human body can be accurately calculated, thereby determining the positional relationship between the needle tip 1012 and the sampling groove 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 it is fired, if the first electromagnetic navigation sensor 11 is fixed inside the needle core 101 and pops out to the far end together with the needle core 101 when it is 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. Furthermore, when the biopsy needle requires secondary or multiple sampling, 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 inward towards the proximal end 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 can easily cause damage to the first electromagnetic navigation sensor 11 and shorten its service life. Moreover, if the fixing structure is not firmly fixed, it will also cause the relative position of the first electromagnetic navigation sensor 11 and the needle core 101 to change, resulting in inaccurate positioning of the spatial position of the needle tip 1012 and the sampling groove 1014 by the navigation device during secondary (or multiple) sampling, thus causing secondary (or multiple) sampling failure. Therefore, to facilitate the production of the needle core 101 and the assembly of the first electromagnetic navigation sensor 11, and to avoid secondary (or multiple) sampling failures caused by changes in the relative position of the first electromagnetic navigation sensor 11 and the needle core 101 during use, in the fully automated biopsy needle provided in the example embodiment of this application, the first electromagnetic navigation sensor 11 is not fixed to the sensor assembly channel 1013 of the needle body 1011, and there is no need to design a fixing structure inside the sensor assembly channel 1013 to fix the first electromagnetic navigation sensor 11. In specific use, the biopsy needle assembly 1 is first adjusted to the energy storage state, and then the first electromagnetic navigation sensor is... 11. After assembling the first electromagnetic navigation sensor 11, the biopsy needle assembly 1, which is in a stored state, is inserted into the human body for firing and sampling. When the firing assembly 6 drives the biopsy needle assembly 1 to switch from the stored state to the firing state, the first electromagnetic navigation sensor 11 remains stationary. The specific spatial positions of the needle tip 1012 and the sampling groove 1014 after firing can be calculated from the spatial position of the first electromagnetic navigation sensor 11 and the dimensional relationship between the target position of the sensor assembly channel and the needle tip 1012 and the sampling groove 1014. This design not only enables the positioning of the needle tip 1012 and the sampling groove 1014 during surgery, but also has a simple structure, is easy to manufacture, and the first electromagnetic navigation sensor is not easily damaged.

[0064] To facilitate precise and convenient assembly of the first electromagnetic navigation sensor 11, as shown in Figures 8 and 9, a connecting through hole 12 is provided at the proximal end of the housing in this embodiment. The connecting through hole 12 communicates with the sensor assembly channel 1013. A first connector is installed on the connecting through hole 12. The first connector has a channel formed inside, suitable for the elongated first electromagnetic navigation sensor 11 to pass through. The first connector is configured to extend through it to 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 connection to a navigation device, and the first electromagnetic navigation sensor 11 and the first connector are relatively fixed. It should be noted that the relatively fixed arrangement of the first electromagnetic navigation sensor 11 and the first connector means that the first electromagnetic navigation sensor 11 is fixed relative to the first connector along the sensor axis, and there is no restriction on the relative movement relationship between the first electromagnetic navigation sensor 11 and the first connector in the circumferential direction. In some embodiments, when the first electromagnetic navigation sensor 11 and the first connector are quickly detached, the first electromagnetic navigation sensor 11 can rotate relative to the first connector in the circumferential direction.

[0065] During assembly, the operator can hold the first electromagnetic navigation sensor 11, align its distal end with the channel of the first connector, insert the proximal end of the first electromagnetic navigation sensor 11 into the first connector, 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 the surgeon's grip on the automated biopsy needle housing (also known as the handle) may twist during biopsy, if the first electromagnetic navigation sensor 11 is fixed to the biopsy needle assembly 1, the first electromagnetic navigation sensor 11 will twist along with the housing, potentially causing damage due to the torque generated by the twisting. Therefore, in this embodiment, the connection between the first connector and the connecting through hole 12 is configured such that the first connector can rotate relative to the connecting through hole under external torque. This way, when the first electromagnetic navigation sensor 11 is subjected to external torque, it can adaptively rotate relative to the navigation device and the biopsy needle assembly 1 along with the first connector, preventing damage to the first electromagnetic navigation sensor 11 or affecting its positioning accuracy due to torque.

[0067] More specifically, in this embodiment, as shown in Figures 8 and 9, a connecting cap 13 is provided at the distal end of the first connector. The connecting cap 13 can be inserted into the connecting through hole 12, and an annular groove is provided on the side wall of the connecting cap 13. Correspondingly, an annular protrusion 23 is provided on the inner wall of the connecting through hole 12. The annular protrusion 23 and the annular groove cooperate with each other. When the first electromagnetic navigation sensor is subjected to an external torque, the first connector, which is fixed relative 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 this application does not limit the position of the annular groove and the annular protrusion 23. In some other embodiments, the annular 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.

[0068] More specifically, the proximal end of the first electromagnetic navigation sensor 11 is fitted with a second connector, and 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 installed, and the distal end of the second connector is detachably connected to the proximal end of the first connector. Thus, when the first electromagnetic navigation sensor 11 needs to be assembled, the surgeon can hold the second connector and connect the distal end of the second connector to the proximal end of the first connector mounted on the connecting through hole 12, thereby completing the assembly of the first electromagnetic navigation sensor 11 onto the fully automated biopsy needle.

[0069] In a preferred embodiment of this invention, the distal end of the second connector and the proximal end of the first connector are connected in a quick-release manner. Specifically, the distal end of the second connector is configured as a plug, and the proximal end of the first connector is configured 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 rotatable connection, which is not limited in this application.

[0070] To further ensure the accuracy of the assembly, the connection between the second connector and the first connector is configured such that when the two are connected in place, the distal end of the first electromagnetic navigation sensor 11 extends precisely into the target position of the sensor assembly channel 1013.

[0071] As a preferred embodiment of this invention, as shown in Figures 8 and 9, the first connector is a first connecting pipe 22, and the second connector is a second connecting pipe (not shown in the figures). The inner diameter of the first connecting pipe 22 is larger than the outer diameter of the first electromagnetic navigation sensor 11, that is, there is a gap between the first connecting pipe 22 and the first electromagnetic navigation sensor 11, which makes it easier for the first electromagnetic navigation sensor 11 to be inserted. The second connecting pipe is fixed to the first electromagnetic navigation sensor 11.

[0072] As an example of the preferred embodiment described above, the first electromagnetic navigation sensor 11 is a thin, elongated wire, and the second connecting tube can be a split structure, comprising a first connecting sub-tube on the distal side and an insulating sheath wrapped around the outside of the wire on the proximal side. The wire is fixed inside the insulating sheath. Both the first connecting sub-tube and the first connecting tube 22 of the second connecting tube are transparent plastic tubes. When manufacturing the first electromagnetic navigation sensor 11, the wire without insulating sheath on the distal side is inserted into the first connecting sub-tube, and then the distal end of the insulating sheath is fixed to the proximal end of the first connecting sub-tube using heat-shrink tubing (or other fastening methods). When assembling the first electromagnetic navigation sensor 11, the surgeon holds the insulating sheath on the outside of the first connecting tube or wire and inserts the distal wire into the first connecting tube 22 until the distal wire extends into the distal end of the sensor assembly channel 1013 of the biopsy needle. Then, the surgeon can quickly connect the distal end of the first connecting tube to the proximal end of the first connecting tube 22, so that the distal end of the wire just extends into the target position at the distal end of the sensor assembly channel 1013, thus 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 other embodiments, there may be multiple sensors, which, in addition to being arranged at the distal end of the wire, may also be arranged at other locations along the wire.

[0074] Furthermore, 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 first electromagnetic navigation sensor 11. Then, the operator holds the second connecting tube and inserts the first electromagnetic navigation sensor 11 into the first connecting tube 22. Then, the operator 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 is exactly inserted into the target position at the distal end of the sensor assembly channel 1013.

[0075] More specifically, the first electromagnetic navigation sensor 11 has a quick-connect male connector at its proximal end, and the navigation device has a quick-connect female connector for engaging with the quick-connect male connector. The quick-connect male connector and the quick-connect female connector can form a fixed mechanical connection, and at the same time, the quick-connect male connector and the quick-connect female connector also realize the electrical connection between the first electromagnetic navigation sensor 11 and the navigation device. The positions of the quick-connect male connector and the quick-connect female connector can be interchanged.

[0076] This application does not limit the detachable fixed connection between the distal end of the second connecting tube and the proximal end of the first connecting tube 22. It can be a quick-connect fixed connection or a threaded connection, as long as it can achieve both fixation and detachment between the second connecting tube and the first connecting tube 22.

[0077] In practical use, the first connecting tube 22 and the fully automated biopsy needle are a kit, and the first electromagnetic navigation sensor 11 and the second connecting tube are a kit. The fully automated biopsy needle may have different length specifications depending on the actual situation, while the length of the first electromagnetic navigation sensor 11 is usually fixed. In order to enable the first electromagnetic navigation sensor 11 to extend into the target position of fully automated biopsy needles of different length specifications, in this embodiment, the first connecting tube 22 is designed with different length specifications to match the fully automated biopsy needles of different length specifications (for example, when the length of the fully automated biopsy needle is short, the length of the first connecting tube 22 is longer), so as to ensure that when the first connecting tube 22 and the second connecting tube are connected, the first electromagnetic navigation sensor 11 can extend into the target position of the fully automated biopsy needle.

[0078] In this embodiment, as shown in Figures 4 and 5, a fixing and protective tube 14 is also provided at the proximal end of the housing. The proximal end of the biopsy needle assembly 1 extends into the fixing and protective tube 14. The fixing and protective tube 14 is used to protect the biopsy needle assembly 1 and guide the first electromagnetic navigation sensor 11 into the sensor assembly channel 1013 during assembly. The fixing and protective tube 14 serves two purposes: firstly, it protects the first electromagnetic navigation sensor 11, preventing damage from other components within the housing; secondly, it guides the assembly of the first electromagnetic navigation sensor 11, making it easier for the operator to insert 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 groove 1014, in this embodiment, the center of the fixed protective tube 14, the connecting through hole 12, and the center of the sensor assembly channel 1013 are further aligned. This ensures that the center of the first electromagnetic navigation sensor 11 is aligned with the center of the sensor assembly channel 1013 during assembly, which helps the navigation device to obtain the spatial position of the needle tip 1014 and the sampling groove 1014 based on the specific spatial position of the first electromagnetic navigation sensor 11 and the specific dimensions and relative positional relationship between the first electromagnetic navigation sensor 11, the needle tip 1012, and the sampling groove 1014. On the other hand, since the fixed protective tube 14 and the sensor assembly channel 1013 are kept aligned, the portion of the first electromagnetic navigation sensor 11 located on the outer side of the proximal end of the needle body 1011 is also constrained to be aligned with the center of the portion 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 outer side of the proximal end of the needle body 1011 still maintains a straight extension within 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, which are fired rapidly in the distal direction, will not cause damage to the first electromagnetic navigation sensor 11, nor will the sensor assembly channel 1013 cut off 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 the sampling.

[0081] Furthermore, the end of the needle tube 102 is provided with a ring blade. 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 located in the sampling groove 1014 from the tissue to obtain a tissue sample.

[0082] In this embodiment, the needle tip 1012 and the needle body 1011 are separately disposed to facilitate separate processing of the needle tip 1012 and the needle body 1011. The needle tip 1012 is a solid structure, and the sampling groove 1014 is disposed on the needle tip 1012. Further, the end of the needle body 1011 is provided with a connector, and the end of the needle tip 1012 is provided with a connector hole that mates with the connector. The needle tip 1012 is installed on the needle body 1011 by inserting the connector into the connector hole. Specifically, the connector can be a cylinder integrally formed with the needle body 1011, and the connector hole is a blind hole on the needle tip 1012 that matches the diameter of the cylinder. By inserting the cylinder into the blind hole, the needle tip 1012 and the needle body 1011 are connected. Glue, adhesive, or welding 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 secure.

[0083] In this embodiment, the needle core 101 and the needle tube 102 are slidably disposed, with the needle tube 102 slidably sleeved on the outside of the needle core 101. The needle core 101 and the needle tube 102 slide sequentially. The needle core 101 moves to the target position first, and the tissue at the target position fills the sampling groove 1014. Then, the needle tube 102 slides relative to the needle core 101. During the sliding process, the annular blade at the end of the needle tube 102 cuts and separates the tissue located in the sampling groove 1014 from other tissues when it passes through the sampling groove 1014, thereby completing the sampling work.

[0084] In this embodiment, rubber sleeves can be fitted onto 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 fitted onto 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 other particles from falling into the needle tube 102.

[0085] In this embodiment, as shown in Figures 7, 10, and 11, a firing assembly 6 and a triggering assembly 5 are also included, which are disposed inside the housing 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 housing 2. The firing assembly 6 also has a firing state that causes the needle core 101 and needle tube 102 in the biopsy needle assembly 1 to eject sequentially. The firing assembly 6 sequentially drives the needle core 101 and needle tube 102 to extend outward toward the distal end of the housing 2, so that there is a time difference during the extension of the needle core 101 and needle tube 102, so that the needle core 101 and needle tube 102 can complete the biopsy sampling. The triggering 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 triggering component 5 includes a trigger key and a triggering link 15. The trigger key can be pressed and installed on the proximal end face of the housing. The triggering link 15 is installed inside the housing and located on the distal side of the trigger key. When the operator presses the trigger key, the trigger key drives the triggering link 15 to move from the initial position to the trigger position. When the triggering link 15 moves to the trigger position, it triggers the firing component 6. The firing component 6 switches from the energy storage state to the firing state, driving the biopsy needle component 1 to extend outward to the distal end of the housing for biopsy sampling.

[0087] In this embodiment, the trigger link 15 has elastic wings 52 extending to opposite sides. A baffle is formed in the mounting cavity of the trigger assembly to resist the elastic wings 52. When the trigger link 15 moves from the initial position to the trigger position, the baffle resists the elastic wings 52 to deform and store energy. After the trigger key releases the drive of the trigger link 15, the trigger link 15 drives the 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 original position.

[0088] Furthermore, the trigger link 15 is formed with a third slider 51, and 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, as shown in Figures 4 and 6, a locking component is also included. The locking component includes a locking member 19, which is rotatably mounted on the proximal side of the housing. The locking member 19 has an unlocked position and a locked position. In the locked position, the locking member 19 is inserted between the triggering component 5 and the firing component 6 by rotating along the circumferential direction of the housing. In the locked position, the locking member 19 prevents the triggering component 5 from moving to the triggering position. A fixed support plate is formed inside the housing. The fixed support plate is configured such that when the locking member 19 is rotated to the locked position, the distal end of the locking member 19 abuts against the fixed support plate 20.

[0090] Furthermore, by setting the locking position between the trigger component 5 and the firing component 6, i.e., setting the locking position on the trigger path, even if the operator accidentally touches it, the triggering force borne by the locking member 19 is much less than the firing force in related technologies, thus avoiding damage and failure of the locking member 19. On the other hand, the locking member 19 is horizontally rotated and installed in the housing. The horizontal rotation installation method can reduce the vertical space occupied, which is beneficial to reducing the overall vertical size of the biopsy needle. Furthermore, by setting a fixed support plate 20 to support the distal end face of the locking member 19 at the locking position, the locking member 19 can withstand greater axial force and is less prone to deformation. Compared with the cantilever beam scheme that inserts into the housing and reaches into the trigger path to lock the trigger component 5, the scheme of rotating and inserting into the trigger path and being supported by the fixed support plate 20 in this application allows the locking member 19 to withstand greater axial force and is less prone to deformation. Importantly, it eliminates the need for opening holes on the left and right sides of the housing, avoiding the situation where the housing strength decreases due to opening holes, thus reducing the overall strength of the product.

[0091] Further describing the locking assembly, in this embodiment, the locking assembly also 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. An oblong hole extending along the axial direction of the housing is provided on the housing. The locking key 21 is rotatably installed in the oblong hole. When the locking key 21 moves within the oblong hole, it can drive the locking member 19 to switch between the unlocked position and the locked position. Considering the strength of the locking assembly, preferably, the locking key 21 and the locking member 19 are an integral structure, but this application is not limited to this. In other embodiments, the locking key 21 and the locking member 19 can be two independent components, fixedly connected by a fixed connection structure. The form of the fixed connection structure is not limited and can be snap-fit, adhesive, etc.

[0092] Furthermore, when the locking member 19 moves to the locked position, and the operator presses the trigger button 3, the trigger link 15 squeezes the proximal end face of the locking member 19, and the distal end face of the locking member 19 abuts against the fixed support plate 20. The locking member 19 is stuck between the trigger link 15 and the fixed support plate 20, preventing the trigger link 15 from moving to the trigger position. This ensures that the biopsy needle assembly 1 in the fully automatic biopsy needle will not pop out for sampling before unlocking, thus ensuring that the biopsy needle assembly 1 reaches the target position before biopsy sampling is performed, and ensuring the accuracy of the sampling results.

[0093] Furthermore, the end face of the locking member 19, which is used to insert between the trigger assembly 5 and the firing assembly 6, is formed with a clearance slope 191 for cooperating with the trigger linkage 15. During biopsy sampling, multiple samplings are sometimes required. After multiple firings of the fully automated biopsy needle, the automatic return function of the trigger link 15 may decrease, making it impossible for the trigger link 15 to accurately return to its initial position. In this case, when the locking member 19 is rotated and inserted between the trigger link 15 and the firing assembly 6, it is easily blocked by the trigger link 15, which has not returned to its initial position, preventing the locking member 19 from moving to the locking position. The design of the relief slope 191 allows for a certain amount of clearance, so that when the locking member 19 moves towards the locking position, the end of the trigger link 15 first contacts the relief slope 191. With the assistance of the relief slope 191, the trigger link 15 can be pushed towards the initial position, so that the locking member 19 can move completely to the locking position through the relief slope 191, thus better locking the fully automated biopsy needle.

[0094] Further, as shown in Figures 4, 5, and 11, the fixed support plate 20 is the cavity wall on the far side of the trigger assembly mounting cavity, and a first slot 16 is formed in the middle of the fixed support plate 20 for the firing assembly 6 to extend and engage with the extended end of the firing assembly 6. When the firing assembly 6 is in the energy storage state, it extends out from the first slot 16. When the extended end of the firing assembly 6 is engaged with the first slot 16, the firing assembly 6 remains in the energy storage state. When the trigger linkage 15 in the trigger assembly 5 moves to the trigger position, it can disengage the extended end of the firing assembly 6 from the first slot 16, so that the firing assembly 6 switches from the energy storage state to the firing state.

[0095] In this embodiment, the housing includes an outer shell 2 and an inner shell. The inner shell is formed by fastening 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.

[0096] 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 firing assembly 62 enter the firing state in sequence so that the needle core 101 and the needle tube 102 are ejected in a preset order.

[0097] Furthermore, the first sub-firing assembly 61 includes a first slider 611 and a first elastic element 612, and the second sub-firing assembly 62 includes a second slider 621 and a second elastic element 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 that compresses the first elastic element 612 to cause the needle core 101 to contract, and the first slider 611 also has a firing state in the first cavity that drives the needle core 101 to eject under the elastic force of the first elastic element 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 that compresses the second elastic element 622 to cause the needle tube 102 to contract, and the second slider 621 also has a firing state in the second cavity that drives the needle tube 102 to eject under the elastic force of the second elastic element 622.

[0098] Specifically, the first end of the first slider 611 has a first engaging portion, and the first cavity has a first slot 16 that mates with the first engaging portion. When the first engaging portion engages into the first slot 16, the first slider 611 enters an energy storage state. When the first engaging portion disengages from the first slot 16, the first slider 611 enters a firing state. The trigger component 5 can drive the first engaging portion to disengage from the first slot 16, causing the first slider 611 to transition from the energy storage state to the firing state, thereby ejecting the needle core 101. The first end of the second slider 621 has a first engaging portion. The first cavity has a second locking part and a second locking groove 17 that mates with the second locking part. When the second locking part is locked into the second locking groove 17, the second slider 621 enters the energy storage state. When the second locking part is disengaged from the second locking groove 17, the second slider 621 enters the firing state. When the first slider 611 slides to the far end of the first cavity, it can push the second locking part out of the second locking groove 17, so that the second locking part is disengaged from the second locking groove 17, the second slider 621 enters the firing state, and drives the needle tube 102 to pop out.

[0099] In this embodiment, the first end of the first slider 611 is formed with a first elastic block 6111. The first elastic block 6111 passes through the first slot 16 and engages with the side of the first slot 16, so that the first slider 611 remains in an energy storage state. When the third slider 51 slides to the trigger position, the first elastic block 6111 disengages from the first slot 16, and the first slider 611 enters the firing state, driving the needle core 101 to extend outward toward the distal end of the outer shell 2; the first end of the second slider 621 is formed with a second elastic block 6211, the second elastic block 6211... The elastic block 6211 passes through the second slot 17 and engages with the side of the second slot 17, so that the second slider 621 is kept 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, causing the second elastic block 6211 to disengage from the second slot 17. The second slider 621 enters the firing state, driving the needle tube 102 to extend outward to the distal end of the outer shell 2. When the needle core 101 and the needle tube 102 extend outward to the distal end of the outer shell 2, the biopsy sampling of the target location is completed.

[0100] In this embodiment, the outer diameter of the end of the first elastic block 6111 away from the trigger component 5 is larger than the outer diameter of the end of the first elastic block 6111 near the trigger component 5. This allows the first slider 611 to enter and pass through the first slot 16 when the first elastic block 6111 is storing energy. After passing through the first slot 16, the first elastic block 6111 expands radially outward without the pressure from the side wall of the first slot 16. This causes the first elastic block 6111 to engage with the side of the first slot 16, preventing it from sliding out of the first slot 16 and keeping the first slider 6111 in the energy-storing state.

[0101] 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 closer to the first slider 611. This allows the second elastic block 6211 to shift radially inward under the pressure of the side wall of the second slot 17 when the second slider 621 is storing energy. This allows the second elastic block 6211 to enter and pass through the second slot 17. After passing through the second slot 17, the second elastic block 6211 is no longer pressured by the side wall of the second slot 17. The second elastic block 6211 then shifts radially outward to expand, causing it to engage with the side of the second slot 17 and preventing it from sliding out of the second slot 17, thus keeping the second slider 621 in an energy-storing state.

[0102] In this embodiment, the first cavity and the second cavity are connected and are arranged in the moving direction of the needle core 101 and the needle body 1011. This makes it easier to move the needle core 101 and the needle body 1011 when the first slider 611 and the second slider 621 slide in the first cavity and the second cavity. 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 outward to the far end of the outer shell 2.

[0103] In some other embodiments, the first cavity and the second cavity can also be set separately, and the first slider 611 and the second slider 621 can be triggered separately, as long as the first slider 611 and the second slider 621 are triggered in sequence.

[0104] In this embodiment, the inner shell includes a first inner shell 7 and a second inner shell 8, which are fastened together. Both the first inner shell 7 and the second inner shell 8 are installed inside the outer shell 2. The internal spaces of the first inner shell 7 and the second inner shell 8 are formed with a first cavity and a second cavity, which facilitates the rational use of the internal space of 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 models of the first inner shell 7 and the second inner shell 8 can also be assembled to install biopsy needle assemblies 1 of different specifications and models.

[0105] In this embodiment, as shown in Figures 11 and 12, the end of the first elastic block 6111 facing the third slider 51 has a first inclined surface 6112. The inclined direction of the first inclined surface 6112 is 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 first enters the first slot 16. As the first inclined surface 6112 gradually enters, the inner wall of the first slot 16... The first inclined surface 6112 is squeezed, causing the first elastic block 6111 to contract radially inward and eventually enter the first slot 16 completely. After passing through the first slot 16, since there is no longer the restriction of the inner wall of the first slot 16, the first elastic block 6111 expands radially outward under its own elastic force and restores its deformation. At this time, the radial dimension of the end of the first elastic block 6111 facing the first slot 16 is larger than the inner diameter of the first slot 16, preventing the first elastic block 6111 from leaving the first slot 16 and keeping the first slider 611 in an energy storage state.

[0106] Furthermore, the end of the third slider 51 facing the first slider 611 has a second inclined surface 511 that matches the first inclined surface 6112. During the process of the third slider 51 sliding to the trigger position, the first elastic block 6111 moves radially inward under the pressure 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. Under the action of the elastic force of the first elastic element 612, the first slider 611 switches from the energy storage state to the firing state, driving the needle core 101 to pop out to the far end of the outer shell 2.

[0107] In this embodiment, the end of the second elastic block 6211 facing the first slider 611 has a third inclined surface 6212. The inclination direction of the third inclined surface 6212 is 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 first enters the second slot 17. As the third inclined surface 6212 gradually enters, the inner wall of the second slot 17 begins to compress. The third inclined surface 6212 causes the second elastic block 6211 to contract radially inward and eventually fully enter the second slot 17. After passing through the second slot 17, since there is no longer the restriction of the inner wall of the second slot 17, the second elastic block 6211 expands radially outward under its own elastic force and restores 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 leaving the second slot 17 and keeping the second slider 621 in an energy storage state.

[0108] Furthermore, the end of the first slider 611 facing the second slider 621 has a fourth inclined surface 18 that matches the third inclined surface 6212. During the process of the first slider 611 sliding to the tail end of the first cavity, the second elastic block 6211 moves radially inward under the compression 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. Under the action of the elastic force of the second elastic member 622, the second slider 621 switches from the energy storage state to the firing state, driving the needle tube 102 to pop out to the far end of the outer shell 2.

[0109] Furthermore, the elastic wing 52 is an elastic plate extending outward from the third slider 51, such as a plate-shaped component made of rubber. There are two elastic plates, located on both sides of the third slider 51 respectively. One end of the elastic plate is connected to the third slider 51, and the other end abuts against or is connected to the inner wall of the inner shell.

[0110] In this embodiment, the elastic wing 52 is formed with a clearance hole through which the fixed protective tube 14 passes and which avoids interference with the fixed protective tube 14 when the triggering link 15 moves. The fixed protective tube 14 passes through the clearance hole and is correspondingly set to the needle body 1011. The diameter of the clearance hole is slightly larger than the outer diameter of the fixed protective tube 14, so that when the triggering link 15 slides and causes the elastic wing 52 to deform, the clearance hole can move slightly on the fixed protective tube 14, thus preventing the clearance hole of the elastic wing 52 from being tightly fitted on the fixed protective tube 14 and unable to move, which would affect the sliding of the triggering link 15.

[0111] In this embodiment, the trigger keys include a side trigger key 4 and a rear trigger key 3, which are respectively located on the side and end of the handle formed by the outer 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. Both the side trigger key 4 and the rear trigger key 3 are connected to the third slider 51 through the trigger link 15. The trigger link 15 is slidably disposed inside the outer shell 2, so that no matter whether the operator operates the side trigger key 4 or the rear trigger key 3, the operator can move the third slider 51 from the initial position to the trigger position through the trigger link 15.

[0112] In this embodiment, a first pressing button 10 and a second pressing button 9 are also included. Both the first pressing button 10 and the second pressing button 9 are slidably installed inside the outer shell 2, and both the first pressing button 10 and the second pressing button 9 are at least partially exposed on the outside of the outer shell 2. The first pressing button 10 is fixedly connected to the first slider 611, and the second pressing button 9 is fixedly connected to the second slider 621. By pressing the first pressing button 10, the operator can control the first slider 611 to retract into the outer shell 2 to reach the energy storage state, and by pressing the second pressing button 9, the operator can control the second slider 621 to retract into the outer shell 2 to reach the energy storage state.

[0113] When performing a biopsy using the fully automated 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 button to drive the firing component 6 to retract the biopsy needle assembly 1 towards the proximal end of the housing to the energy storage state. Then, the distal end of the first electromagnetic navigation sensor 11 is inserted into 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 automated biopsy needle and is connected to the navigation device. At this time, after being powered on, the navigation device can identify the spatial position (position and attitude) of the first electromagnetic navigation sensor 11, and then determine the spatial position (position and attitude) of the needle tip 1012 and the sampling groove 1014 based on the specific dimensional relationship between the target position at the distal end of the sensor assembly channel 1013 and the needle tip 1012 and the sampling groove 1014 of the biopsy needle assembly 1. The operator can then select the needle insertion point on the body surface and adjust the needle insertion path according to the navigation. The operator confirms that the target point to be punctured is on the needle insertion path and that the crosshair used to indicate the position of the needle tip 1012 is on the target point to be punctured. Then the biopsy needle assembly 1 is inserted into the target point of the human body.

[0114] 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 crosshair of the biopsy needle assembly 1 is located at the pre-puncture target point according to the navigation, there is actually a firing distance difference between the position of the needle tip 1012 (or the center of the sampling groove) of the biopsy needle assembly 1 and the target target point. At this time, the operator controls the firing assembly 6 to switch the biopsy needle assembly 1 from the energy storage state to the firing state, and the needle tip 1012 (or the center of the sampling groove) of the biopsy needle assembly 1 will just pierce the target sampling position (target target point).

[0115] It should also be noted that before firing, the locking component of the biopsy needle assembly 1 is always in the locked position to prevent the operator from accidentally triggering it. When the crosshair of the biopsy needle assembly 1 is aimed at the pre-puncture target point, the locking component is switched from the locked position to the unlocked position, and the triggering component 5 is operated to trigger the firing component 6, so that the firing component 6 switches from the energy storage state to the firing state, and the target tissue sampling is completed.

[0116] Example 2

[0117] This embodiment provides a specific implementation of an electromagnetic positioning-based biopsy system, including the fully automated biopsy needle, the second electromagnetic navigation sensor, and the navigation device described in Embodiment 1. 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 and second electromagnetic navigation sensors and determine the spatial relationship between the fully automated biopsy needle and the ultrasound probe based on these electromagnetic signals.

[0118] Furthermore, in this embodiment, the ultrasound probe is an intraoperative ultrasound probe, and the second electromagnetic navigation sensor is snapped onto the transmitting acoustic window at the distal end of the ultrasound probe via a snap-fit ​​assembly. It should be noted that this application is not limited to intraoperative ultrasound probes; it can also be an external ultrasound probe.

[0119] When the ultrasound probe is an intraoperative ultrasound probe, the navigation device can locate the tip and sampling slot of the fully automated biopsy needle, as well as the intraoperative ultrasound probe, by positioning the first electromagnetic navigation sensor 11 and the second electromagnetic navigation sensor. This allows the navigation device to obtain the relative positional relationship between the tip of the fully automated biopsy needle and the intraoperative ultrasound probe. The navigation device can also display this relative positional relationship on a display device, enabling the surgeon to perform biopsy sampling on the patient under the display device's view and with real-time images of internal organs captured by the intraoperative ultrasound probe. This significantly improves biopsy efficiency and accuracy.

[0120] Other embodiments of this application will readily conceive of by those skilled in the art upon consideration of the specification and practice of the embodiments thereof. This application is intended to cover any variations, uses, or adaptations of this application that follow the general principles of this application and include common knowledge or customary techniques in the art not claimed in this application. The specification and embodiments are to be considered exemplary only, and the true scope and spirit of this application are indicated by the appended claims.

Claims

1. A fully automated biopsy needle, characterized in that, include: Housing, firing assembly, trigger assembly, biopsy needle assembly, and first electromagnetic navigation sensor; The firing assembly, triggering assembly, biopsy needle assembly, and first electromagnetic navigation sensor are assembled in the housing; The firing assembly is connected to the biopsy needle assembly. The firing assembly has an energy storage state in which it drives the biopsy needle assembly to retract inward toward the proximal end of the housing, and a firing state in which it drives the biopsy needle assembly to extend outward toward the distal end of the housing under the triggering of the triggering assembly. During the switching process from the energy storage state to the firing state, the biopsy needle assembly completes biopsy sampling. The triggering component is used to trigger the firing component to switch the firing component from the energy storage state to the firing state; The biopsy needle assembly includes a needle core and a needle tube that are sleeved together. The needle core includes a needle tip located at the distal end and a needle body that connects to the proximal end of the needle tip and extends towards 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 of the needle body. The first electromagnetic navigation sensor has 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 remains stationary.

2. The fully automated biopsy needle according to claim 1, characterized in that, The housing has a connecting through hole at its proximal end, which communicates with the sensor assembly channel. A first connector is mounted on the connecting through hole. A connecting cap is provided at the distal end of the first connector, and the connecting cap is inserted into the connecting through hole. An annular protrusion or an annular groove is provided on the sidewall of the connecting cap, and an annular groove or an 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 engagement of the annular protrusion and the annular groove. The distal end of the first electromagnetic navigation sensor extends through the first connector to the target position in the sensor assembly channel. The proximal end of the first electromagnetic navigation sensor is adapted to be connected to a navigation device. The first electromagnetic navigation sensor and the first connector are fixedly positioned relative to each other. The first electromagnetic navigation sensor has a second connector sleeved on its proximal end, and the distal end of the first electromagnetic navigation sensor extends through the distal end of the second connector. The first electromagnetic navigation sensor and the second connector are fixedly installed, and the distal end of the second connector is detachably connected to the proximal end of the first connector. When the distal end of the second connector is connected to the proximal end of the first connector, the distal end of the first electromagnetic navigation sensor extends into the target position of the sensor assembly channel.

3. The fully automated biopsy needle according to claim 2, characterized in that, A fixed protective tube is provided inside the near end of the housing. The fixed protective tube, the connecting through hole, and the sensor assembly channel are aligned at their centers. The distal end of the first electromagnetic navigation sensor with a slender structure extends through the connecting through hole and the fixed protective tube into the target position of the sensor assembly channel. Its proximal end is suitable for connecting to a navigation device. The length of the needle core extending into the fixed protective tube is set such that the needle core will not come 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 switches to the energy storage state with the firing assembly.

4. The fully automated biopsy needle according to claim 2 or 3, characterized in that, The housing includes an outer shell and an inner shell. The outer shell 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. The firing assembly, the trigger assembly, and the biopsy needle assembly are respectively assembled in the firing assembly mounting cavity, the trigger assembly mounting cavity, and the biopsy needle assembly mounting cavity. The connecting through hole is opened on the proximal end face of the housing and communicates with the trigger assembly mounting cavity. The proximal end of the fixing protective tube is fixed to the housing and communicates with the connecting through hole. The distal end of the fixing protective tube extends through the trigger assembly into the biopsy needle assembly mounting cavity.

5. The fully automated biopsy needle according to claim 4, characterized in that, The triggering component includes a rear trigger key and a trigger link, the rear trigger key and the trigger link having an initial position and a trigger position that moves along a trigger path toward the distal end of the housing to trigger the firing component to switch from the energy storage state to the firing state, the rear trigger key and the trigger link switching between the initial position and the trigger position during the movement; The trigger link has a pair of elastic wings extending to both sides. The trigger assembly mounting cavity has a baffle wall formed to resist the elastic wings. When the trigger link moves from the initial position to the trigger position, the baffle wall resists the elastic wings to deform and store energy. After the rear trigger key releases the drive of 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. The elastic wing has a clearance hole for the fixed protective tube to pass through, and the clearance hole is configured so that the elastic wing does not interfere with the fixed protective tube when it moves with the trigger linkage.

6. The fully automated biopsy needle according to claim 5, characterized in that, It also includes a locking assembly comprising a locking member and a locking key. The locking member is rotatably mounted on the proximal side of the housing. The locking member has an unlocked position and a locked position that rotates circumferentially along the housing between the triggering assembly and the firing assembly. In the locked position, the locking member prevents the triggering assembly from moving to the triggering position. A fixed support plate is formed within the housing. The fixed support plate is configured to abut against the distal end face of the locking member when the locking member is rotated to the locked position. The proximal end face of the locking member abuts against the trigger linkage. The locking key is assembled on the housing. The locking key is fixedly connected to the locking member or is an integral structure. The housing has an oblong hole extending circumferentially along the housing. The locking key is rotatably mounted in the oblong hole along the circumferential direction of the housing and drives the locking member to switch between the unlocked position and the locked position.

7. The fully automated biopsy needle according to claim 6, characterized in that, The locking member has an insertion end face formed with a clearance slope for cooperating with the trigger link.

8. The fully automated biopsy needle according to claim 7, characterized in that, The rear trigger key and the connecting through hole are distributed side by side on the end face of the near end of the housing. The rear trigger key is inclined on the end face of the near end of the housing, and the rear trigger key is at least partially exposed on the outside of the housing. The rear trigger key and the trigger linkage are separately disposed. The triggering component also includes a side triggering key, which is fixedly connected to the triggering link. The side triggering key switches between an initial position and a triggering position as it slides along the triggering link. The side trigger key is located on the side of the housing, and the rear trigger key is located at the proximal end of the housing.

9. The fully automated biopsy needle according to any one of claims 1-8, characterized in that, The needle tip and the needle body are separate components, and the proximal end of the needle tip and the distal end of the needle body are connected by adhesive or welding.

10. The fully automated biopsy needle according to any one of claims 1-8, characterized in that, The firing assembly includes a first sub-firing assembly disposed at the proximal end and a second sub-firing assembly disposed at the distal end. The first sub-firing assembly includes a first slider and a first elastic element, and the second sub-firing assembly includes a second slider and a second elastic element. The firing assembly mounting cavity within the housing has a first cavity located proximally and a second cavity located distally. A first slider and a first elastic element are mounted in the first cavity, while a second slider and a second elastic element are mounted in the second cavity. The needle core is fixed to the first slider, which is slidably mounted within the first cavity. The first slider has a stored energy state within the first cavity, compressing the first elastic element to retract the needle core. It also has a firing state within the first cavity, ejecting the needle core. The needle tube is fixed to the second slider, which is slidably mounted within the second cavity. The second slider has a stored energy state within the second cavity, compressing the second elastic element to retract the needle tube. It also has a firing state within the second cavity, ejecting the needle tube. The first slider, triggered by the triggering component, switches from the stored energy state to the firing state, simultaneously ejecting the needle core distally. When the first slider switches to the firing state, it triggers the second slider to switch from the stored energy state to the firing state, simultaneously ejecting the needle tube distally.

11. A biopsy system based on electromagnetic positioning, characterized in that, Includes the fully automated biopsy needle, the second electromagnetic navigation sensor, and the navigation device according to any one of claims 1-10; The second electromagnetic navigation sensor is fixedly connected to the ultrasonic probe; The navigation device is configured to extract the electromagnetic signals received by the first electromagnetic navigation sensor and the second electromagnetic navigation sensor, and determine the spatial positional relationship between the fully automated biopsy needle and the ultrasound probe based on the electromagnetic signals.

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