Full-automatic biopsy needle based on electromagnetic navigation positioning
By setting up a sensor assembly channel and a fixed protective tube in the fully automated biopsy needle, the problem of damage to the electromagnetic navigation sensor during firing is solved, and a more efficient and accurate biopsy operation is achieved.
Patent Information
- Application Number
- CN202422505502.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-16
- Publication Date
- 2025-10-28
- Estimated Expiration
- 2034-10-16
AI Technical Summary
Existing fully automatic biopsy needles are prone to damaging the electromagnetic navigation sensor when the firing device is fired quickly, resulting in product failure and surgical failure.
A hollow sensor assembly channel is set inside the biopsy needle assembly. The fixed protective tube is aligned with the connecting through hole to ensure that the electromagnetic navigation sensor is not damaged during firing. The fixed protective tube guides the sensor to maintain a straight extension.
It effectively protects the electromagnetic navigation sensor, preventing it from being cut or damaged during firing, thus improving the efficiency and accuracy of biopsy.
Smart Images

Figure CN223473781U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical device technology, and more specifically, to a fully automated biopsy needle based on electromagnetic navigation and positioning. 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] The fully automated biopsy needle includes a biopsy needle assembly, a handle, a firing device, etc. The biopsy needle assembly consists of a needle core and a needle tube. The needle core is equipped with a sampling groove. The firing device is used to control the needle core and the needle tube to pop out one after the other to complete the sampling.
[0004] In related technologies, the surgeon can only determine the puncture point on the patient's body surface, but cannot accurately grasp the specific location of the biopsy needle after it enters the body, nor the positional relationship between the needle tip and the sampling groove and the target sampling location. The operation must rely solely on the surgeon's experience. To address this, the applicant proposes a fully automated biopsy needle incorporating electromagnetic positioning. Specifically, a first electromagnetic navigation sensor is mounted on the fully automated biopsy needle, utilizing electromagnetic navigation technology to accurately position the needle tip and sampling groove. However, in practical implementation, due to the high firing force of the firing device, the biopsy needle assembly is prone to damage to the first electromagnetic navigation sensor when fired rapidly, potentially even causing it to break, leading to product failure and surgical failure. Utility Model Content
[0005] The purpose of this invention is to provide a fully automated biopsy needle based on electromagnetic navigation positioning, which aims to solve the problem that the first electromagnetic navigation sensor is easily damaged under rapid firing of the firing device and biopsy needle assembly.
[0006] Additional aspects and advantages of this invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention.
[0007] According to a first aspect of the present invention, a fully automated biopsy needle based on electromagnetic navigation and positioning is provided, comprising:
[0008] Housing, firing assembly, biopsy needle assembly, and fixing and protective tube;
[0009] The firing assembly, biopsy needle assembly, and fixed protective tube are assembled into the housing;
[0010] The biopsy needle assembly has a hollow sensor assembly channel formed inside, which is used for the insertion of a slender first electromagnetic navigation sensor.
[0011] The firing assembly has an energy storage state that drives the biopsy needle assembly to retract inward toward the proximal end of the housing and a firing state that drives the biopsy needle assembly to extend outward toward the distal end of the housing. During the switching between the energy storage state and the firing state, the biopsy needle assembly performs biopsy sampling.
[0012] The housing has a connection through hole at its proximal end, and the fixing protection tube is fixedly installed inside the proximal end of the housing and aligned with the center of the connection through hole on the proximal side and the sensor assembly channel on the distal side.
[0013] The distal end of the first electromagnetic navigation sensor is adapted to pass through the connecting through hole and extend into the target position at the distal end of the sensor assembly channel, while its proximal end is adapted to connect to a navigation device.
[0014] In an exemplary embodiment of this utility model, the biopsy needle assembly includes a slidably sleeved needle core and a needle tube. The needle core includes a needle tip disposed at the distal end and a needle body connected to the proximal end of the needle tip and extending towards the proximal end of the housing. The sensor assembly channel is formed inside the needle body. The proximal end of the needle core extends into the interior of the fixed protective tube. 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 out from the proximal port of the fixed protective tube when the needle core switches to the energy storage state with the firing assembly.
[0015] In an exemplary embodiment of this utility model, the axial proximal side of the connecting through hole is used to install a first connector. The first connector has a channel formed in the middle. The distal end of the first electromagnetic navigation sensor is adapted to pass through the channel of the first connector, pass through the fixed protective tube, and be inserted into the target position of the sensor assembly channel of the needle body. The first connector and the first electromagnetic navigation sensor are fixedly arranged relative to each other.
[0016] In an exemplary embodiment of the present invention, the connection between the distal end of the first connector and the connecting through hole is configured such that the first connector can rotate relative to the connecting through hole under external torque.
[0017] In an exemplary embodiment of the present invention, a connecting cap is provided at the distal end of the first connector. The connecting cap is inserted into the connecting through hole. A positioning protrusion or an annular groove is provided on the side wall of the connecting cap. An annular groove or a positioning protrusion is provided on the inner wall of the connecting through hole. The connecting cap is rotatably connected to the connecting through hole through the cooperation of the positioning protrusion and the annular groove.
[0018] In an exemplary embodiment of this invention, the fully automated biopsy needle further includes a triggering component;
[0019] The housing has 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.
[0020] The connecting through hole is formed on the proximal end face of the housing and communicates with the trigger assembly mounting cavity. The proximal end of the fixing protection tube is fixed to the housing and communicates with the connecting through hole. The distal end of the fixing protection tube extends through the trigger assembly into the biopsy needle assembly mounting cavity.
[0021] In an exemplary embodiment of the present invention, the triggering component has an initial position and a triggering position for moving along a triggering path toward the distal end of the housing to trigger the firing component to switch from the energy storage state to the firing state;
[0022] The triggering component includes a rear trigger button and a trigger linkage. Both the rear trigger button and the trigger linkage are slidably installed in the housing. During the sliding process, the rear trigger button and the trigger linkage switch between the initial position and the trigger position.
[0023] The trigger link has a pair of elastic wings extending to both sides. The trigger assembly mounting cavity has a baffle formed to resist the elastic wings. When the trigger link moves from the initial position to the trigger position, the baffle 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.
[0024] In an exemplary embodiment of this utility model, the elastic wing is provided with 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.
[0025] In an exemplary embodiment of the present invention, the rear trigger key and the connecting through hole are arranged side by side on the end face of the near end of the housing.
[0026] In an exemplary embodiment of the present invention, 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.
[0027] The exemplary embodiments of this utility model may have some or all of the following beneficial effects:
[0028] In the fully automated biopsy needle based on electromagnetic navigation positioning provided in the exemplary embodiment of this utility model, a novel structure for a fully automated biopsy needle that can be combined with a first electromagnetic navigation sensor is first proposed. Specifically, the fully automated biopsy needle includes a housing, a firing assembly, a biopsy needle assembly, and a fixing and protective tube. The firing assembly, biopsy needle assembly, and fixing and protective tube are assembled inside the housing. The biopsy needle assembly has a hollow sensor assembly channel formed inside, which is used for the insertion of a slender first electromagnetic navigation sensor. The firing assembly has the function of driving the biopsy needle assembly towards the proximal end of the housing. The device has an inward-retracting energy storage state and a firing state that drives the biopsy needle assembly to extend outward toward the distal end of the housing. During the switching from the energy storage state to the firing state, the biopsy needle assembly performs biopsy sampling. A connecting through hole is provided at the proximal end of the housing, and a fixed protective tube is fixedly installed inside the proximal end of the housing and aligned with the center of the connecting through hole on the proximal side and the sensor assembly channel on the distal side. The distal end of the first electromagnetic navigation sensor is adapted to pass through the connecting through hole and extend into the target position at the distal end of the sensor assembly channel through the fixed protective tube. The proximal end of the first electromagnetic navigation sensor is adapted to connect with an external navigation device.
[0029] Firstly, by forming a hollow sensor assembly channel inside the biopsy needle assembly, and extending the sensor assembly channel along the length of the biopsy needle assembly, a slender first electromagnetic sensor is adapted to extend into the sensor assembly channel. In use, the distal end of the first electromagnetic navigation sensor is extended to the target position at the distal end of the sensor assembly channel, and the proximal end extends out from the proximal opening of the fully automated biopsy needle to connect to the navigation device. This allows the first electromagnetic navigation sensor to be positioned under the navigation device. Furthermore, based on the target position and the set size relationship between the needle tip and the sampling groove of the biopsy needle assembly, the specific spatial position (position and orientation) of the needle tip and the sampling groove can be determined, which helps the operator improve the efficiency and accuracy of the biopsy procedure.
[0030] Secondly, considering the narrow space of the sensor assembly channel, it is difficult to design a fixing structure inside it for fixing the slender first electromagnetic navigation sensor. That is, the slender first electromagnetic navigation sensor does not fire together with the biopsy needle assembly. Because the first electromagnetic navigation sensor is thin and long, it is difficult to ensure that the proximal opening of the sensor assembly channel of the needle body is aligned with the first electromagnetic navigation sensor during assembly. During biopsy sampling, because the firing device fires rapidly (or instantaneously) when switching from the energy storage state to the firing state, the firing force is large. This rapid and large firing force can easily cause the sensor assembly channel of the needle body to generate rapid and large frictional forces on the first electromagnetic navigation sensor, or even shearing forces, thereby damaging or even shearing the first electromagnetic navigation sensor. Therefore, in the fully automated biopsy needle provided in this exemplary embodiment of the present invention, by setting a fixed protective tube at the proximal end of the housing and aligning the center of the fixed protective tube with the center of the connecting through hole on its proximal side and the sensor assembly channel on its distal side, the fixed protective tube can guide the first electromagnetic navigation sensor to more easily penetrate into the sensor assembly channel of the needle body. Furthermore, because the fixed protective tube and the sensor assembly channel are centered, the portion of the first electromagnetic navigation sensor located on the outer side of the proximal end of the needle body is also constrained to be centered with the portion of the first electromagnetic navigation sensor extending into the sensor assembly channel. That is, the first electromagnetic navigation sensor extending from the outer side of the proximal end of the needle body maintains a straight extension within the fixed protective tube. When the firing assembly drives the biopsy needle assembly to switch from the energy storage state to the firing state, the needle body and its sensor assembly channel, which are rapidly fired towards the distal end, will not cause damage to the first electromagnetic navigation sensor, nor will the sensor assembly channel cut off the first electromagnetic navigation sensor.
[0031] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit the present invention. Attached Figure Description
[0032] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments conforming to the present invention and, together with the description, serve to explain the principles of the present invention. It is obvious that the drawings described below are merely some embodiments of the present invention, and those skilled in the art can obtain other drawings based on these drawings without any inventive effort.
[0033] Figure 1 This diagram shows a structural schematic of a fully automated biopsy needle based on electromagnetic navigation and positioning in Embodiment 1 of this utility model;
[0034] Figure 2 An exploded view of a fully automated biopsy needle based on electromagnetic navigation and positioning according to Embodiment 1 of this utility model is shown.
[0035] Figure 3 This figure shows a partial exploded view of a fully automated biopsy needle based on electromagnetic navigation and positioning according to Embodiment 1 of this utility model;
[0036] Figure 4 This shows a cross-sectional view of the firing assembly in the energy storage state in Embodiment 1 of the present invention;
[0037] Figure 5 It shows Figure 4 Enlarged view of point A in the middle;
[0038] Figure 6 This diagram illustrates the connection between the first connecting tube, the connecting cap, and the first electromagnetic navigation sensor in Embodiment 1 of this utility model.
[0039] Figure 7 It shows Figure 6 Enlarged view of point B in the middle;
[0040] Figure 8 This diagram shows the structure of the firing assembly in the firing state in Embodiment 1 of this utility model;
[0041] Figure 9 A cross-sectional view of the firing assembly in the firing state in Embodiment 1 of this utility model is shown;
[0042] Figure 10 A schematic diagram of the firing assembly in Embodiment 1 of this utility model is shown;
[0043] Figure 11 An exploded view of the needle core in the biopsy needle assembly of Embodiment 1 of this utility model is shown.
[0044] Explanation of reference numerals in the attached figures:
[0045] 1. Biopsy needle assembly; 101. Needle core; 1011. Needle body; 1012. Needle tip; 1013. Sensor assembly channel; 1014. Sampling slot; 102. Needle tube;
[0046] 2. Outer shell; 3. Rear trigger button; 4. Side trigger button; 5. Trigger assembly; 51. Third slider; 511. Second inclined surface; 52. Elastic wing;
[0047] 6. Firing assembly; 61. First sub-firing assembly; 611. First slider; 6111. First elastic block; 6112. First inclined surface; 612. First elastic element; 62. Second sub-firing assembly; 621. Second slider; 6211. Second elastic block; 6212. Third inclined surface; 622. Second elastic element;
[0048] 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 locking hole; 17. Second locking hole; 18. Fourth inclined surface; 19. Locking element; 191. Avoidance inclined surface; 20. Fixing support plate; 21. Locking button; 22. First connecting tube; 23. Positioning protrusion. Detailed Implementation
[0049] 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 the present invention 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 description will be omitted. Furthermore, the drawings are merely illustrative of the present invention and are not necessarily drawn to scale.
[0050] Although relative terms such as "upper" and "lower" are used in this specification to describe the relative relationship of one component of 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.
[0051] 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.
[0052] "Proximal end" refers to the end closer to the practitioner, while "distal end" refers to the end farther away from the practitioner.
[0053] Example 1
[0054] This embodiment provides a specific implementation of a fully automated biopsy needle based on electromagnetic navigation and positioning, such as... Figure 1 , Figure 2 , Figure 3 , Figure 4 and Figure 5As shown, the device includes a housing, a firing assembly 6, a biopsy needle assembly 1, and a fixing and protective tube 14. The firing assembly 6, biopsy needle assembly 1, and fixing and protective tube 14 are assembled inside the housing. The biopsy needle assembly 1 has a hollow sensor assembly channel 1013 formed inside, which is used for the insertion of a first electromagnetic navigation sensor 11. The firing assembly 6 is connected to the biopsy needle assembly 1 and has an energy storage state that retracts the biopsy needle assembly 1 towards the proximal end of the housing and a firing state that extends the biopsy needle assembly 1 towards the distal end of the housing. During the transition from the energy storage state to the firing state, the biopsy needle assembly 1 performs a biopsy sampling; a connection through hole 12 is provided at the proximal end of the housing, and a fixed protective tube 14 is fixedly installed inside the proximal end of the housing and aligned with the center of the connection through hole 12 on the proximal side and the sensor assembly channel 1013 on the distal side; the distal end of the slender first electromagnetic navigation sensor 11 is adapted to pass through the connection through hole 12 and the fixed protective tube 14 and extend into the target position at the distal end of the sensor assembly channel 1013, and the proximal end of the first electromagnetic navigation sensor 11 is adapted to be connected to an external navigation device.
[0055] In this embodiment, the first aspect is as follows: Figure 5 , Figure 6 and Figure 7 As shown, a hollow sensor assembly channel 1013 is formed inside the biopsy needle assembly 1, and the sensor assembly channel 1013 extends along the length of the biopsy needle assembly 1. The slender first electromagnetic navigation sensor 11 is adapted to extend into the sensor assembly channel 1013. In use, the distal end of the first electromagnetic navigation sensor 11 is extended into the target position at the distal end of the sensor assembly channel 1013, and the proximal end extends out from the proximal opening of the fully automatic biopsy needle to connect to the navigation device. This allows the first electromagnetic navigation sensor 11 to be positioned under the navigation device. Then, based on the target position and the set size relationship between the needle tip 1012 and the sampling groove 1014 of the biopsy needle assembly 1, the specific spatial position (position and orientation) of the needle tip 1012 and the sampling groove 1014 can be determined, which helps the operator improve the efficiency and accuracy of the biopsy procedure.
[0056] Secondly, considering the narrow space of the sensor assembly channel 1013, it is difficult to design a fixing structure for fixing the slender first electromagnetic navigation sensor 11 inside it. That is, the slender first electromagnetic navigation sensor 11 does not fire together with the biopsy needle assembly when it is fired. Because the first electromagnetic navigation sensor 11 is thin and long, it is difficult to ensure that the proximal opening of the sensor assembly channel 1013 of the needle body 1011 is aligned when assembling the first electromagnetic navigation sensor 11. During biopsy sampling, since the firing assembly 6 fires rapidly (or instantaneously) when switching from the energy storage state to the firing state, the firing force is large. The rapid and large firing force can easily cause the sensor assembly channel 1013 of the needle body to form a rapid and large frictional force on the first electromagnetic navigation sensor 11, or even a shearing force, thereby damaging or even cutting the first electromagnetic navigation sensor 11. Therefore, in the fully automated biopsy needle provided in the example embodiment of this utility model, by setting a fixed protective tube 14 at the proximal end of the housing and aligning the fixed protective tube 14 with the center of the connecting through hole 12 on its proximal side and the sensor assembly channel 1013 on its distal side, the setting of the fixed protective tube 14 can, on the one hand, guide the first electromagnetic navigation sensor 11 to be more conveniently inserted into the sensor assembly channel 1013 of the needle body. On the other hand, since the fixed protective tube 14 and the sensor assembly channel 1013 are aligned with the center, the part of the first electromagnetic navigation sensor 11 located on the proximal side of the needle body 1011 is also constrained to be aligned with the center of the part of the first electromagnetic navigation sensor 11 extending into the sensor assembly channel 1013. That is, the first electromagnetic navigation sensor 11 extending from the proximal side 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, and there will be no phenomenon that the sensor assembly channel 1013 cuts off the first electromagnetic navigation sensor 11.
[0057] In this embodiment, as Figure 11As shown, the biopsy needle assembly 1 includes a movably sleeved needle core 101 and a needle tube 102. The needle core 101 includes a needle tip 1012 disposed at the distal end and a needle body 1011 connecting the proximal end of the needle tip 1012 and extending towards the proximal end of the housing. A sensor assembly channel 1013 is formed inside the needle body 1011. The proximal end of the needle core 101 extends into the fixed protective tube 14. The length of the needle core 101 extending into the fixed protective tube 14 is set such that the needle core 101 will not detach from the distal end of the fixed protective tube 14 when the firing assembly 6 fires, and will not protrude from the proximal end of the fixed protective tube 14 when the needle core 101 switches to the energy storage state with the firing assembly 6. This design requires calculation of the length of the needle body 1011 based on the size of the housing, the required firing distance, and the size of the fixed protective tube 14. The dimensions ensure that the proximal end of the needle body 1011 remains within the fixed protective tube 14 during both the energy storage and firing states of the firing assembly 6. This prevents the proximal end of the needle body 1011 from ever leaving the fixed protective tube 14, further guaranteeing the accurate center alignment of the fixed protective tube 14, the connecting through hole 12, and the sensor assembly channel 1013. Simultaneously, it prevents the first electromagnetic navigation sensor 11 from being difficult to extend into the sensor assembly channel 1013 through the guide of the fixed protective tube 14 after the sensor assembly channel 1013 has detached from the fixed protective tube 14. The fact that the proximal end of the needle body 1011 remains within the fixed protective tube 14 facilitates the first electromagnetic navigation sensor 11's extension into the sensor assembly channel 1013 through the guide of the fixed protective tube 14, ensuring that the first electromagnetic navigation sensor 11 extends in a straight line.
[0058] Furthermore, to facilitate the assembly of the first electromagnetic navigation sensor 11, a first connector is installed on the axial proximal side of the connecting through hole 12. The middle of the first connector has a channel formed for the first electromagnetic navigation sensor 11 to pass through. During assembly, the distal end of the first electromagnetic navigation sensor 11 passes through the connecting through hole 12 via the first connector, then through the fixed protective tube 14, and extends all the way to the target position within the sensor assembly channel of the needle body. To ensure that the first electromagnetic navigation sensor 11 does not fire along with the needle body during firing, in this embodiment, the first connector and the first electromagnetic navigation sensor are fixedly positioned relative to each other. Specific examples of this relatively fixed positioning will be described in detail below.
[0059] Furthermore, in this embodiment, a connecting cap 13 is provided at the distal end of the first connector, and the connecting cap 13 can be inserted into the connecting through hole 12, such as... Figure 6 and Figure 7As shown, the distal end of the first electromagnetic navigation sensor 11 passes through the connecting cap 13 and extends into the sensor assembly channel 1013. The connection between the connecting cap 13 and the connecting through hole 12 is configured such that the connecting cap 13 can rotate relative to the connecting through hole 12 under external torque. The first electromagnetic navigation sensor 11 is positioned so that it protrudes from the connecting cap 13 at the center of the connecting through hole 12 after the connecting cap 13 is connected to the connecting through hole 12. This ensures that the position where the first electromagnetic navigation sensor 11 passes through the connecting cap 13 is the center of the connecting through hole 12. On the other hand, the connecting cap 13 is configured to rotate relative to the connecting through hole 12 under external torque. When performing a biopsy, the surgeon may twist the fully automated biopsy needle. If the fully automated biopsy needle causes the first electromagnetic navigation sensor 11 to twist, it may cause the first electromagnetic navigation sensor 11 to twist itself, which could easily lead to damage. Therefore, by configuring the connecting cap 13 to rotate relative to the connecting through hole 12 under external torque, when the surgeon twists or even rotates the fully automated biopsy needle, the connecting cap 13 and the first electromagnetic navigation sensor 11 will adaptively rotate relative to the housing of the fully automated biopsy needle, thereby preventing the first electromagnetic navigation sensor 11 from twisting itself and causing damage.
[0060] Furthermore, an annular groove is provided on the side wall of the connecting cap 13, and correspondingly, a positioning protrusion 23 is provided on the inner wall of the connecting through hole 12. The positioning protrusion 23 and the annular groove cooperate with each other. When the first electromagnetic navigation sensor is subjected to an external torque, the first connecting member, which is fixed relative to the first electromagnetic navigation sensor 11, can rotate relative to the connecting through hole 12 under the cooperation of the positioning protrusion 23 and the annular groove. It should be noted that the position of the annular groove and the positioning protrusion 23 is not limited in this utility model. In some other embodiments, the positioning protrusion 23 is formed on the side wall of the connecting cap 13, and the annular groove is formed on the inner wall of the connecting through hole 12.
[0061] Furthermore, a second connector is fitted onto the proximal end of the first electromagnetic navigation sensor 11, 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.
[0062] 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, and this invention does not limit this.
[0063] 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.
[0064] As a preferred embodiment of this example, Figure 6 and Figure 7 As shown, the first connector is the first connecting tube 22, and the second connector is the second connecting tube (not shown in the figure). The inner diameter of the first connecting tube 22 is larger than the outer diameter of the first electromagnetic navigation sensor 11, that is, there is a gap between the first connecting tube 22 and the first electromagnetic navigation sensor 11, which makes it easier for the first electromagnetic navigation sensor 11 to be inserted. The second connecting tube is fixed to the first electromagnetic navigation sensor 11.
[0065] 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.
[0066] It should be noted that, in this embodiment, the sensor is preferably arranged at the distal end of the wire. However, this invention 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.
[0067] Furthermore, in this embodiment, during actual assembly, the operator first connects the first connecting tube 22 to the connecting through hole 12 through the connecting cap 13, which is equivalent to providing an installation channel for the 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.
[0068] More specifically, the proximal end of the first electromagnetic navigation sensor 11 is provided with a quick-connect male connector, and the navigation device is provided with a quick-connect female connector for mating 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.
[0069] In this embodiment, a triggering component 5 and a locking component are also included. The triggering component 5 is used to trigger the firing component 6, causing the firing component 6 to switch from the energy storage state to the firing state. The locking component has an unlocking position and a locking position that prevents the triggering component 5 from triggering the firing component 6. The biopsy needle assembly 1, the first electromagnetic navigation sensor 11, the firing component 6, the triggering component 5, and the locking component are all assembled in the housing. The biopsy needle assembly 1 is provided with a hollow sensor assembly channel 1013, which is used to assemble the first electromagnetic navigation sensor 11. In use, the surgeon inserts the first electromagnetic navigation sensor 11 into the target position at the far end of the sensor assembly channel 1013, thereby identifying the spatial position of the first electromagnetic navigation sensor 11 under the navigation device, and thus determining the spatial position of the biopsy needle assembly 1. The firing assembly 6 is connected to the biopsy needle assembly 1. The firing assembly 6 has an energy storage state in which the biopsy needle assembly 1 is retracted towards the proximal end of the housing, and a firing state in which the biopsy needle assembly 1 is extended towards the distal end of the housing under the triggering of the triggering assembly 5. During the switching between the energy storage state and the firing state, the biopsy needle assembly 1 performs biopsy sampling. The triggering assembly 5 is used to trigger the firing assembly 6 and is assembled on the proximal side of the firing assembly 6 on the housing. The triggering assembly 5 has an initial position and moves along a trigger path towards the distal end of the housing to trigger the firing assembly 6 from the energy storage state. The trigger position for switching between the firing state and the firing state; the locking assembly 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 trigger assembly 5 and the firing assembly 6 by rotating along the circumferential direction of the housing. In the locked position, the locking member 19 prevents the trigger assembly 5 from moving to the trigger 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.
[0070] When performing a biopsy using the fully automated biopsy needle of this embodiment, the surgeon first adjusts the fully automated biopsy needle to the energy storage state. Then, the surgeon inserts the first electromagnetic navigation sensor 11 into the target position at the distal end of the sensor assembly channel 1013. The proximal end of the first electromagnetic navigation sensor protrudes from the proximal end of the fully automated biopsy needle and connects to the navigation device. The navigation device can identify the spatial position of the first electromagnetic navigation sensor, and then determine the spatial position of the needle tip and sampling groove by the specific dimensional relationship between the target position at the distal end of the sensor assembly channel and the needle tip and sampling groove of the biopsy needle assembly. Then, the needle is inserted into the human body according to the pre-planned surface puncture point and puncture path. Under the guidance of the navigation device, the surgeon can insert the fully automated biopsy needle, which drives the first electromagnetic navigation sensor, into the target sampling tissue (target point). Then, the surgeon controls the trigger component 5 to move from the initial position to the trigger position. Under the drive of the trigger component 5, the firing component 6 switches from the energy storage state to the firing state. During this process, the biopsy needle assembly 1 extends outward towards the distal end of the housing to perform biopsy sampling. When the biopsy needle assembly 1 has not reached the target sampling position in the tissue, the locking component on the fully automated biopsy needle is in the locked position. The locking component includes a locking member 19, which is rotatably mounted on the proximal side of the housing. The direction of rotation of the locking member 19 is the circumferential direction of the housing. When the locking member 19 rotates in the axial direction of the housing, it can be inserted between the trigger assembly 5 and the firing assembly 6. A fixed support plate 20 is formed in the housing to abut the locking member 19 when it is in the locked position. When locking the fully automated biopsy needle, the locking member 19 is rotated from the unlocked position to the locked position. At this time, even if a mis-trigger occurs, causing the trigger assembly 5 to move from the initial position to the trigger position, it will squeeze the locking member 19 onto the fixed support plate 20. The trigger assembly 5 will not reach the trigger position, and thus the trigger assembly 5 will not change the state of the firing assembly 6.
[0071] By placing the locking component between the trigger component 5 and the firing component 6, the trigger component 5 is prevented from moving to the trigger position. This serves two purposes: First, it avoids placing the locking component in the firing path of the firing component 6. When the firing component 6 fires, it has already switched from the energy storage state to the firing state. If the locking component blocks the firing component 6 from firing, the firing component 6 will remain in the firing state at all times. The spring force is large, and prolonged compression under this force could easily cause the locking component to fail. Second, by placing the locking component between the trigger component 5 and the firing component 6, in the event of accidental activation, the trigger component 5 presses against the locking member 19, causing the locking member 19 to abut against the fixed support plate 20. This prevents the trigger component 5 from moving to the trigger position, and the firing component 6 remains in the energy storage state. The locking member 19 experiences almost no deformation and has high strength. Simultaneously, the locking member 19 can form a reasonable distribution with the biopsy needle assembly 1 and the first electromagnetic navigation sensor 11, without interference within the housing, and without requiring through holes in the housing, thus maintaining its strength.
[0072] In this embodiment, the locking assembly further includes a locking key 21 mounted on the housing. The locking key 21 is fixedly connected to the locking member 19 or is an integral structure. 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. In this embodiment, the locking key 21 and the locking member 19 are preferably integrally formed.
[0073] In this embodiment, the triggering component 5 includes a rear trigger key 3 and a trigger link 15. The rear trigger key 3 is pressably mounted on the proximal end face of the housing. The trigger link 15 is mounted inside the housing and located on the distal side of the rear trigger key 3. When the surgeon presses the rear trigger key 3, the rear trigger key 3 drives the trigger link 15 to move from the initial position to the trigger position. When the trigger link 15 moves to the trigger position, 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. The rear trigger key 3 and the connecting through hole 12 are distributed side by side on the proximal end face of the housing. On the one hand, the first electromagnetic navigation sensor needs to pass through the housing to reach the distal target position of the sensor assembly channel 1013, which requires openings in the housing; on the other hand, the rear trigger key 3 can be tilted and set on the proximal end face of the housing, and the rear trigger key 3 is at least partially exposed on the outside of the housing to facilitate pressing by the surgeon. Since the rear trigger key 3 and the connecting through hole 12 are arranged side by side on the end face of the near end of the housing, it would be inconvenient to process the rear trigger key 3 if it were integrally formed with the trigger link 15. Therefore, the rear trigger key 3 and the trigger link are designed as separate parts, and the two are demolded separately, which reduces the difficulty of overall demolding and facilitates the processing of the rear trigger key 3 and the trigger link 15.
[0074] 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.
[0075] Furthermore, the end face of the locking member 19, which is inserted between the trigger assembly 5 and the firing assembly 6, is formed with a relief slope 191 for cooperating with the trigger link 15. After the fully automatic biopsy needle has been fired multiple times, the automatic return function of the trigger link 15 may decrease, making it impossible for the trigger link 15 to accurately return to the initial position. At this time, 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 the initial position, making it impossible for the locking member 19 to move to the locking position. The design of the relief slope 191 allows for a certain size, so that when the locking member 19 moves to 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 automatic biopsy needle.
[0076] In this embodiment, the housing has 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 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. Further, 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 through 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.
[0077] Furthermore, the fixed support plate 20 is the cavity wall on the far side of the trigger assembly mounting cavity, and a first locking hole 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 locking hole 16. When the extended end of the firing assembly 6 is engaged with the first locking hole 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 locking hole 16, so that the firing assembly 6 switches from the energy storage state to the firing state.
[0078] In this embodiment, the trigger link 15 has elastic wings 52 extending to opposite sides. A baffle wall 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 wall resists the elastic wings 52 to deform and store energy. After the rear trigger key 3 releases the drive of the trigger link 15, the trigger link 15 drives the rear trigger key 3 to automatically move from the trigger position to the initial position under the deformation recovery action of the elastic wings 52, so that the rear trigger key 3 and the trigger link 15 can automatically return to their original positions. Furthermore, after multiple firings of the fully automated biopsy needle, the elastic fin 52 may experience elastic fatigue, preventing the trigger link 15 and the rear trigger key 3 from returning to their initial positions. 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 size, 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.
[0079] In this embodiment, the firing assembly 6 and the triggering assembly 5 are disposed inside the housing. 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. 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 in sequence. The firing assembly 6 drives the needle core 101 and needle tube 102 to extend outward toward the distal end of the housing in sequence, 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.
[0080] Furthermore, the trigger assembly 5 also includes a third slider 51 formed on the trigger link 15. Elastic wings 52 extend from both sides of the third slider 51. When the operator presses the trigger button, the trigger button drives the third slider 51 to slide from the initial position to the trigger position, thereby driving the firing assembly 6 to switch from the energy storage state to the firing state.
[0081] In this embodiment, as Figure 8 , Figure 9 and Figure 10 As shown, the firing assembly 6 includes a first sub-firing assembly 61 and a second sub-firing assembly 62. The firing assembly mounting cavity includes a first cavity and a second cavity. The first sub-firing assembly 61 is installed in the first cavity, 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.
[0082] 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.
[0083] Specifically, the first slider 611 has a first locking portion at its first end, and a first locking hole 16 that mates with the first locking portion inside the first cavity. When the first locking portion engages with the first locking hole 16, the first slider 611 enters an energy storage state. When the first locking portion disengages from the first locking hole 16, the first slider 611 enters a firing state. The trigger component 5 can drive the first locking portion to disengage from the first locking hole 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... The first slide has a second locking part at one end and a second locking hole 17 inside the second cavity that mates with the second locking part. When the second locking part is locked into the second locking hole 17, the second slider 621 enters the energy storage state. When the second locking part is disengaged from the second locking hole 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 hole 17, so that the second locking part is disengaged from the second locking hole 17, the second slider 621 enters the firing state, and drives the needle tube 102 to pop out.
[0084] 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 locking hole 16 and engages with the side of the first locking hole 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 locking hole 16, and the first slider 611 enters the firing state, driving the needle core 101 to extend outward toward the distal end of the housing; the first end of the second slider 621 is formed with a second elastic block 6211, the second The elastic block 6211 passes through the second locking hole 17 and engages with the side of the second locking hole 17, so that the second slider 621 remains 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 locking hole 17. The second slider 621 enters the firing state, driving the needle tube 102 to extend outward to the far end of the housing. When the needle core 101 and the needle tube 102 extend outward to the far end of the housing, the biopsy sampling of the target location is completed.
[0085] 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 close to the trigger component 5. This allows the first slider 611 to enter and pass through the first card hole 16 when the first elastic block 6111 is storing energy. After passing through the first card hole 16, the pressure from the side wall of the first card hole 16 is removed, and the first elastic block 6111 expands radially outward. This causes the first elastic block 6111 to engage with the side of the first card hole 16, preventing it from sliding out of the first card hole 16 and keeping the first slider 6111 in the energy-storing state.
[0086] 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 locking hole 17 when the second slider 621 is storing energy. This allows the second elastic block 6211 to enter and pass through the second locking hole 17. After passing through the second locking hole 17, the second elastic block 6211 is no longer pressured by the side wall of the second locking hole 17. The second elastic block 6211 then shifts radially outward to expand, causing it to engage with the side of the second locking hole 17 and preventing it from sliding out. This keeps the second slider 621 in an energy-storing state.
[0087] In this embodiment, the first cavity and the second cavity are connected and are arranged in the direction of movement 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 shell.
[0088] 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.
[0089] In this embodiment, 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 locking hole 16, so that when the first slider 611 slides, the first inclined surface 6112 first enters the first locking hole 16. As the first inclined surface 6112 gradually enters, the inner wall of the first locking hole 16 begins to compress the first... The inclined surface 6112 causes the first elastic block 6111 to contract radially inward and eventually enter the first locking hole 16 completely. After passing through the first locking hole 16, since there is no longer the restriction of the inner wall of the first locking hole 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 locking hole 16 is greater than the inner diameter of the first locking hole 16, preventing the first elastic block 6111 from disengaging from the first locking hole 16 and keeping the first slider 611 in an energy storage state.
[0090] 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 card hole 16, so that the first elastic block 6111 can break away from the restriction of the first card hole 16 and enter the first card hole 16. Under the action of the elastic force of the first elastic member 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 housing.
[0091] 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 locking hole 17, so that when the second slider 621 slides, the third inclined surface 6212 first enters the second locking hole 17. As the third inclined surface 6212 gradually enters, the inner wall of the second locking hole 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 locking hole 17. After passing through the second locking hole 17, since there is no longer the restriction of the inner wall of the second locking hole 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 locking hole 17 is greater than the inner diameter of the second locking hole 17, preventing the second elastic block 6211 from disengaging from the second locking hole 17, and keeping the second slider 621 in an energy storage state.
[0092] 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 locking hole 17, so that the second elastic block 6211 can break away from the restriction of the second locking hole 17 and enter the second locking hole 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 housing.
[0093] In this embodiment, a fixed protective tube 14 is also provided inside the housing. The fixed protective tube 14 is aligned with the sensor assembly channel 1013. The first electromagnetic navigation sensor 11 is guided into the sensor assembly channel 1013 by the fixed protective tube 14. The fixed protective tube 14 passes through the elastic wing 52. The elastic wing 52 has a clearance hole formed on it, through which the fixed protective tube 14 passes and avoids interference with the fixed protective tube 14 when the trigger link 15 moves. The fixed protective tube 14 passes through the clearance hole and is corresponding 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 trigger link 15 slides and causes the elastic wing 52 to deform, the clearance hole can move slightly on the fixed protective tube 14, avoiding the clearance hole of the elastic wing 52 being tightly fitted on the fixed protective tube 14 and unable to move, thus affecting the sliding of the trigger link 15.
[0094] 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.
[0095] 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.
[0096] In this embodiment, the needle tip 1012 and the needle body 1011 are separately configured to facilitate separate processing of the needle tip 1012 and the needle body 1012. The needle tip 1012 is a solid structure, and the sampling groove 1014 is provided 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 has a connector hole that mates with the connector. The needle tip 1012 is installed onto 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 with a diameter matching that of the cylinder. By inserting the cylinder into the blind hole, the needle tip 1012 is connected to the needle body 1011. Adhesive or glue 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.
[0097] 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.
[0098] In this embodiment, a rubber sleeve 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 sleeve 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 avoid damage to the needle tip 1012.
[0099] In this embodiment, a side trigger button 4 and a rear trigger button 3 are respectively disposed on the side and tail end of the handle formed by the housing. The side trigger button 4 and the rear trigger button 3 are connected by a trigger link 15. The side trigger button 4 and the rear trigger button 3 move synchronously. No matter which trigger button the operator presses, the other trigger button moves synchronously. The trigger link 15 is connected to the third slider 51. Both the side trigger button 4 and the rear trigger button 3 are connected to the third slider 51 through the trigger link 15. The trigger link 15 is slidably disposed in the housing, so that no matter whether the operator operates the side trigger button 4 or the rear trigger button 3, the operator can drive the third slider 51 from the initial position to the trigger position through the trigger link 15.
[0100] 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 housing, and both the first pressing button 10 and the second pressing button 9 are at least partially exposed on the outside of the housing. 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 housing 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 housing to reach the energy storage state.
[0101] Example 2
[0102] This embodiment provides a specific implementation of an electromagnetic positioning-based biopsy system, including the fully automated biopsy needle based on electromagnetic navigation positioning from Embodiment 1, a second electromagnetic navigation sensor, and a navigation device. In use, the second electromagnetic navigation sensor is fixed to an ultrasound probe, which can be a surface probe or an intraoperative probe; there are no restrictions. The navigation device is configured to extract the electromagnetic signals from 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.
[0103] Other embodiments of the present invention will readily occur to those skilled in the art upon consideration of the specification and practice of the embodiments thereof. The present invention is intended to cover any variations, uses, or adaptations of the invention that follow the general principles of the invention and include common knowledge or customary techniques in the art not covered by the invention. The specification and embodiments are to be considered exemplary only, and the true scope and spirit of the invention are indicated by the appended claims.
Claims
1. A fully automated biopsy needle based on electromagnetic navigation and positioning, characterized in that, include: Housing, firing assembly, biopsy needle assembly, and fixing and protective tube; The firing assembly, biopsy needle assembly, and fixed protective tube are assembled into the housing; The biopsy needle assembly has a hollow sensor assembly channel formed inside, which is used for the insertion of a slender first electromagnetic navigation sensor. The firing assembly has an energy storage state that drives the biopsy needle assembly to retract inward toward the proximal end of the housing and a firing state that drives the biopsy needle assembly to extend outward toward the distal end of the housing. During the switching between the energy storage state and the firing state, the biopsy needle assembly performs biopsy sampling. The housing has a connection through hole at its proximal end, and the fixing protection tube is fixedly installed inside the proximal end of the housing and aligned with the center of the connection through hole on the proximal side and the sensor assembly channel on the distal side. The distal end of the first electromagnetic navigation sensor is adapted to pass through the connecting through hole and extend into the target position at the distal end of the sensor assembly channel, while its proximal end is adapted to connect to a navigation device.
2. The fully automated biopsy needle based on electromagnetic navigation and positioning according to claim 1, characterized in that, The biopsy needle assembly includes a slidably sleeved needle core and needle tube. The needle core includes a needle tip located at the distal end and a needle body connected to the proximal end of the needle tip and extending towards the proximal end of the housing. The sensor assembly channel is formed inside the needle body. The proximal end of the needle core extends into the interior of the fixed protective tube. 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 end of the fixed protective tube when it is fired by the firing assembly, and will not extend out from the proximal end of the fixed protective tube when the needle core switches to the energy storage state with the firing assembly.
3. The fully automated biopsy needle based on electromagnetic navigation and positioning according to claim 2, characterized in that, The axial proximal side of the connecting through hole is used to install the first connector. The first connector has a channel formed in the middle. The distal end of the first electromagnetic navigation sensor is adapted to pass through the channel of the first connector, pass through the fixed protective tube, and be inserted into the target position of the sensor assembly channel of the needle body. The first connector and the first electromagnetic navigation sensor are fixedly set relative to each other.
4. The fully automated biopsy needle based on electromagnetic navigation and positioning according to claim 3, characterized in that, The connection between the distal end of the first connector and the connecting through hole is configured such that the first connector can rotate relative to the connecting through hole under external torque.
5. The fully automated biopsy needle based on electromagnetic navigation and positioning according to claim 4, characterized in that, The distal end of the first connector is provided with a connector cap, which is inserted into the connecting through hole. The side wall of the connector cap is provided with a positioning protrusion or an annular groove, and the inner wall of the connecting through hole is provided with an annular groove or a positioning protrusion. The connector cap is rotatably connected to the connecting through hole through the cooperation of the positioning protrusion and the annular groove.
6. The fully automated biopsy needle based on electromagnetic navigation and positioning according to any one of claims 1-5, characterized in that, The fully automated biopsy needle also includes a triggering component; The housing has 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 formed on the proximal end face of the housing and communicates with the trigger assembly mounting cavity. The proximal end of the fixing protection tube is fixed to the housing and communicates with the connecting through hole. The distal end of the fixing protection tube extends through the trigger assembly into the biopsy needle assembly mounting cavity.
7. The fully automated biopsy needle based on electromagnetic navigation and positioning according to claim 6, characterized in that, The triggering component has an initial position and a triggering position that moves along a triggering 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 triggering component includes a rear trigger button and a trigger linkage. Both the rear trigger button and the trigger linkage are slidably installed in the housing. During the sliding process, the rear trigger button and the trigger linkage switch between the initial position and the trigger position. The trigger link has a pair of elastic wings extending to both sides. The trigger assembly mounting cavity has a baffle formed to resist the elastic wings. When the trigger link moves from the initial position to the trigger position, the baffle 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.
8. The fully automated biopsy needle based on electromagnetic navigation and positioning according to claim 7, characterized in that, 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.
9. The fully automated biopsy needle based on electromagnetic navigation and positioning according to claim 7, characterized in that, The rear trigger key and the connecting through hole are arranged side by side on the end face of the near end of the housing.
10. The fully automated biopsy needle based on electromagnetic navigation and positioning according to claim 9, characterized in that, The rear trigger key is inclinedly disposed on the end face near the end of the housing, and the rear trigger key is at least partially exposed on the outside of the housing.
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Fully automatic biopsy needle and biopsy system based on electromagnetic positioning
WO2026082064A1