Biopsy apparatus

Abstract

A biopsy apparatus, comprising a cutter tube positioning and protection structure (1), a front housing (2), a transmission structure (3), a rear housing (4) and a sample collector structure (5). The cutter tube positioning and protection structure (1) is arranged at the front end of the front housing (2) and is connected to the front housing (2) in a quick-release and quick-mounting manner. The front housing (2) is arranged at the front side of the rear housing (4) and is connected and fixed to the middle end of the biopsy apparatus. The transmission structure (3) is arranged inside an assembly body formed by the front housing (2) and the rear housing (4). The sample collector structure (5) is provided at the rear end of the rear housing (4) and is coaxially and detachably connected to the rear housing (4). The coaxially matched housings solve the problem of a non-coaxial structure being prone to failure in the power transmission process. The cutter tube positioning and protection structure has the functions of protecting the cutter tip and forming a sterile barrier.

Description

A biopsy device Technical Field

[0001] The present invention relates to the technical field of tissue biopsy, and in particular to a biopsy device. Background Art

[0002] Abnormal breast tissue refers to the presence of abnormalities in the breast, such as lumps, tumors, or other abnormalities. Diagnosing abnormalities in breast tissue generally requires a breast biopsy. A breast biopsy involves removing a small sample of abnormal breast tissue and sending it to a laboratory for examination.

[0003] In the prior art, biopsy devices are generally used to biopsy or remove abnormal breast tissue. The current method of using biopsy devices is to find abnormal tissue under ultrasound guidance and use the biopsy device to sample or remove it. However, the biopsy devices currently used in the market have the following defects:

[0004] (1) The frame of the existing biopsy device generally adopts the upper and lower shell mode. This frame mode is not firmly connected. When the biopsy device is connected to the corresponding control handle of the biopsy device, the biopsy device will be affected by the separation force of the driving gear on the control handle during use. Even the active wheel on the control handle and the driven wheel on the biopsy device may slip, resulting in surgical failure, affecting the user experience and endangering the safety of the patient.

[0005] (2) The current biopsy device has a problem in which the splines are sucked out of the knife groove and accumulated in the sample collector, and the splines may stick to the upper wall of the sample collector cavity or the collection chamber is located on the end face of the inner cavity of the sample collector, so that the splines cannot fall into the receiving net and cannot be completely removed, resulting in missed detection.

[0006] (3) Existing biopsy devices do not have a blade positioning protection structure. The biopsy device needs to be calibrated by the host's drive handle before use. Due to the accuracy of software control, there will be a certain deviation in its circumferential position, which will affect the doctor's use. In addition, the calibration process is long, and the doctor needs to wait for the calibration to be completed before performing the operation, which prolongs the entire biopsy blade operation time and wastes medical resources.

[0007] Summary of the Invention

[0008] To address the above-mentioned issues, the present invention aims to provide a biopsy device with a main frame consisting of a front shell and a rear shell, which are securely connected and provide a pleasant feel. A sample collector is also provided to collect intact samples after sampling for testing. Furthermore, a quick-release and quick-install blade barrel positioning and protection structure is provided to ensure that the outer blade barrel of the biopsy device does not move before the first use. The rotation direction of the outer blade barrel does not need to be zeroed, and accidental injury to the user or others is avoided.

[0009] The above-mentioned object of the present invention is achieved through the following technical solutions:

[0010] A biopsy device comprises: a knife tube positioning and protection structure, a front shell, a transmission structure, a rear shell and a sample collector structure; the knife tube positioning and protection structure is arranged at the front end of the front shell and is connected to the front shell by a quick-release and quick-install method; the front shell is arranged at the front side of the rear shell and is connected and fixed to the middle end of the biopsy device, and the transmission structure is arranged inside the assembly composed of the front shell and the rear shell; the sample collector structure is arranged at the rear end of the rear shell and is connected to the rear shell in a coaxial and detachable manner.

[0011] Furthermore, the knife tube positioning protection structure includes a needle sleeve and a base; the needle sleeve is arranged on the front side of the base, and the needle sleeve and the base are connected by an axial hole matching mechanical connection method including glue injection, tight fit, hot melt, ultrasonic and threaded fixation; an unlocking structure is provided on the base, and the unlocking structure has plastic elasticity to ensure that the unlocking structure is not unlocked in the absence of external force, so that the knife tube positioning protection structure remains connected to the front shell, and when the unlocking structure is pressed, the knife tube positioning protection structure is released and separated from the front shell, and the base has an inner hole, and the inner hole has a plurality of grooves evenly distributed along the circumference.

[0012] Furthermore, the transmission structure includes an outer knife tube, a front sleeve of the outer tube and an inner knife tube;

[0013] The outer tube front sleeve is located at the rear side of the outer knife tube, and the outer tube front sleeve is coaxially connected to the outer knife tube, and the outer tube front sleeve and the outer knife tube are coaxially clearance-matched, and the inner knife tube translates in the inner cavity of the outer knife tube to realize the surgical action of cutting; an even number of positioning protrusions are evenly distributed circumferentially on the front side of the outer tube front sleeve, and the positioning protrusions also serve as a scale function to indicate the circumferential angle of the outer knife tube. The front side of the positioning protrusion has a slope, which plays a guiding role when the knife tube positioning protection structure is assembled with the front shell and the transmission structure; the positioning protrusion of the outer tube front sleeve is coaxially matched with the inner hole of the knife tube positioning protection structure. During the production process of the biopsy device, the circumferential angle of the outer knife tube is pre-installed to zero when the knife tube positioning protection structure is assembled with the front shell and the transmission structure.

[0014] Furthermore, the unlocking structure on the base is provided with a release undercut, and the release undercut is engaged with the front fixing groove on the front shell and remains engaged under the plastic elastic force of the unlocking structure itself; the base is also provided with a base positioning groove that is clearance-matched with the positioning protrusion on the front sleeve of the outer tube, ensuring that the direction of the knife tube positioning protection structure is correct when it is inserted, and at the same time ensuring that the transmission mechanism cannot rotate and is located at the rotation origin when the release undercut is engaged; when it is necessary to remove the knife tube positioning protection structure, press the unlocking structure, the unlocking structure moves inward, and the release undercut is disengaged from the front fixing groove, so that the knife tube positioning protection structure can be pulled out; when it is necessary to put on the knife tube positioning protection structure, adjust the base positioning groove and the positioning protrusion to the same direction, put the knife tube positioning protection structure into the outer knife tube, and the chamfer on the unlocking structure automatically guides the release undercut into the front fixing groove, and the release undercut is engaged with the front fixing groove to realize the quick disassembly and quick assembly function.

[0015] Furthermore, the front shell includes a limiting guide groove, a front fixing groove, an anti-slip groove, and a positioning ear piece, and the rear shell includes a rear fixing groove; the limiting guide grooves are axially arranged on both sides of the front shell to increase the strength of the front shell and limit the lower shell of the control handle connected to the biopsy device; the front fixing groove is arranged on the front side of the front shell to connect and fix the knife tube positioning protection structure;

[0016] The anti-slip pattern is arranged at the bottom of the front shell to ensure that the biopsy device will not slip and cause accidents when in use; the positioning ear is circumferentially arranged at one end of the front shell close to the sample collector structure to limit the control handle circumferentially to prevent the control handle from being horizontally misaligned and unusable when it is snapped together with the biopsy device. At the same time, a guide angle is provided on the positioning ear to ensure that the snapping position is in place when the control handle is snapped together with the biopsy device; the rear end fixing groove is arranged on the rear side of the rear shell to connect and fix the sample collector structure.

[0017] Furthermore, the front shell includes a large cylindrical pin, a small cylindrical pin and a front shell boss, and the rear shell includes a first positioning hole, a second positioning hole, and a shell fixing groove; the large cylindrical pin is mechanically fixedly connected to the first positioning hole, and the small cylindrical pin is mechanically fixedly connected to the second positioning hole, wherein the mechanical fixed connection includes methods such as glue filling, tight fit, hot melt, ultrasonic and threaded fastening; the front shell boss is fixed with a clearance fit in the shell fixing groove to ensure that the front shell and the rear shell will not rotate or move circumferentially.

[0018] Furthermore, the front shell includes a first boss, and the rear shell includes a second boss; the transmission structure is arranged inside the assembly composed of the front shell and the rear shell, the inner hole of the first boss on the front shell is matched with the boss on the front sleeve of the outer tube in an axial hole clearance, and the inner knife tube is matched with the inner hole of the second boss on the rear shell in an axial hole clearance, so as to realize the support and rotation of the transmission mechanism on the front shell and the rear shell; the first boss on the front shell and the second boss on the rear shell limit the transmission structure front and rear to prevent the transmission structure from moving back and forth during rotation.

[0019] Furthermore, the sample collector structure includes a sample collector fixing seat, an inner tube seal, an integrated collection bin, a collection bin seal, a sample collector cavity, a release button, and a spring; the sample collector fixing seat is arranged at the front end of the sample collector cavity, the inner tube seal is located between the sample collector fixing seat and the sample collector cavity, and the integrated collection bin is located at the rear end of the sample collector cavity and cooperates with the sample collector cavity; the collection bin seal is placed in the sealing groove on the integrated collection bin, and is used to be squeezed when the sample collector cavity cooperates with the integrated collection bin, thereby achieving the sealing performance of the sample collector cavity, and at the same time ensuring that the integrated collection bin does not shake when it is fixed on the sample collector cavity; the release button and the spring are installed on both sides of the sample collector fixing seat, and the sample collector fixing seat is fixed by several fixed The positioning hole is mechanically connected to several cylindrical bosses on the sample collector cavity; the bottom of the front side of the inner mesh seal is provided with an annular fin, and the annular fin is in line contact with the outer surface of the inner tube in the absence of external force. In addition to the line contact, there is an annular gap between the inner ring of the inner mesh seal and the inner tube; the middle part of the front side of the inner mesh seal is provided with a countersunk hole, and the countersunk hole is used to change the volume of the countersunk hole when the pressure on both sides of the inner mesh seal and the inner tube cut surface is uneven, thereby increasing the sealing performance of the inner mesh seal and the inner tube cut surface; the button buckle on the release button is engaged with the sample collector fixing groove on the sample collector fixing seat, and the spring uses elastic force to ensure that the button buckle is always engaged when there is no external force acting on the spring, and the sample collector fixing groove ensures that the release button moves in a specified direction.

[0020] The sample collector cavity is fitted with the integrated collecting bin, and there are several strip-shaped protrusions on the sample collector cavity. The strip-shaped protrusions are used to prevent the top of the sample collector cavity from sticking to the sample. At the same time, the grooves on the integrated collecting bin that are fitted with the strip-shaped protrusions are used to scrape off the accidentally stuck samples to obtain complete samples; there are guide grooves on both sides of the integrated collecting bin, which are gap-matched with the guide bosses on the sample collector cavity, and at the same time, the joint action of the strip-shaped protrusions is used to achieve the guiding effect of the integrated collecting bin when it enters the sample collector cavity, thereby preventing the integrated collecting bin from rotating.

[0021] The undercut boss on the release button is engaged with the button fixing groove on the rear shell, and the elastic force of the spring is used to ensure that the undercut boss will not be separated from the button fixing groove when no external force acts on the spring, thereby ensuring that the sample collector structure is firmly connected to the rear shell and does not fall off; the rear shell boss on the rear shell and the sample collector positioning groove on the sample collector fixing seat are clearance-matched, and the rear shell positioning groove on the rear shell and the sample collector boss on the sample collector fixing seat are clearance-matched; when When the sample collector structure needs to be removed, the release button is pressed, the spring is compressed, and the inverted boss is disengaged from the button fixing groove, so that the sample collector structure can be pulled out. When the sample collector structure needs to be installed, the release button is pressed, the rear shell boss and the sample collector positioning groove, as well as the rear shell positioning groove and the sample collector boss are adjusted to be consistent in direction, the sample collector structure is installed into the rear shell, the release button is released, the spring rebounds, and the inverted boss is engaged with the button fixing groove, thereby realizing quick disassembly and quick installation.

[0022] Compared with the prior art, the present invention has at least one of the following beneficial effects:

[0023] (1) By providing a main frame composed of a front shell and a rear shell, the main frame is firmly connected and is not affected by the separation force of the drive gear on the control handle when connected to the control handle, so that the doctor can feel good when using the biopsy device without additional force feedback. This solves the problem that the current frame using the upper and lower shells has a tendency to separate due to the separation force of the drive gear and has a poor feel.

[0024] (2) By providing a sample collector structure with large capacity, good fit, and the ability to obtain complete samples when drawn out, complete samples after sampling can be collected for inspection, and can be used to obtain and store multiple complete tissue samples. At the same time, the sample collector structure of the present invention can save time and effort, be quick to disassemble and install, and be reliable and durable. It is easy to disassemble in special circumstances where the entire sample collector structure is required for inspection. It solves the problems of the current sample collector structure being loosely fixed, inconvenient to disassemble, and having a poor hand feel, the integrated button being easily broken and damaged, the sample collector structure being easily rotated and moved, and the sample taken out not necessarily being complete.

[0025] (3) By providing a reliable, durable, and quick-detachable blade tube positioning and protection structure, the blade tube positioning and protection structure has a quick-detach and quick-install function and a fixed direction function, ensuring that the outer blade tube of the biopsy device will not move before the first use, and the rotation direction of the outer blade tube does not need to be zeroed. The blade tube positioning and protection structure prevents accidental injury to oneself and others in the event of inattention, while ensuring that the blade tube of the biopsy device is intact before use. This solves the current problem of the blade tube protective cover being loose and easy to fall off, and the outer blade tube shaking before use, which requires re-zeroing.

[0026] (4) By providing a front sleeve of the outer tube with a visual scale, the doctor can see the actual rotation angle of the outer tube before and during use, solving the current problem of being unable to know the approximate rotation angle of the outer tube. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] FIG1 is an overall schematic diagram of the biopsy device of the present invention, wherein FIG1(a) is a side view and FIG1(b) is a top view;

[0028] FIG2 is a schematic diagram of a knife tube positioning and protection structure according to the present invention, wherein FIG2(a) is a side view and FIG2(b) is a top view;

[0029] FIG3 is a schematic structural diagram of the front shell and the rear shell of the present invention, wherein FIG3(a) is a front view of the structure of the front shell and the rear shell, and FIG3(b) is a side view of the structure of the front shell and the rear shell;

[0030] FIG4 is a schematic diagram of the connection between the front shell and the rear shell of the present invention, wherein FIG4(a) is a right side view of the connection, FIG4(b) is a front view of the connection, and FIG4(c) is a schematic diagram of the CC surface of the connection;

[0031] FIG5 is a schematic diagram of the transmission structure of the present invention;

[0032] FIG6 is a schematic diagram of the scale markings on the front sleeve of the outer tube of the present invention, wherein FIG6(a) is a front view, FIG6(b) is a perspective view, FIG6(c) is an enlarged view of the front end of the 0-degree positioning protrusion, and FIG6(d) is an enlarged view of the front end of other positioning protrusions;

[0033] FIG7 is a schematic diagram of the connection between the front housing, rear housing and transmission mechanism of the present invention;

[0034] FIG8 is a schematic diagram of the connection between the front shell, the rear shell, and the blade tube positioning protection structure of the present invention, wherein FIG8(a) is a schematic diagram of the BB surface, and FIG8(b) is a front view;

[0035] FIG9 is another schematic diagram of the connection method of the front shell, rear shell and knife barrel positioning protection structure of the present invention, wherein FIG9(a) is a cross-sectional view and FIG9(b) is a three-dimensional view;

[0036] FIG10 is a schematic diagram of the structure of the sample collector of the present invention, wherein FIG10(a) is a schematic diagram on the left side, FIG10(b) is a schematic diagram on the right side, FIG10(c) is a schematic diagram of the overall structure of the sample collector, FIG10(d) is a schematic diagram of the interior of the inner tube seal, and FIG10(e) is a schematic diagram of the CC surface of the sample collector structure;

[0037] FIG11 is a schematic diagram of the release button of the present invention being engaged, wherein FIG11( a ) is a front view and FIG11( b ) is a cross-sectional view.

[0038] Reference numerals 1: blade tube positioning and protection structure; 2: front housing; 3: transmission structure; 4: rear housing; 5: sample collector structure; 11: needle sleeve; 12: base; 121: unlocking structure; 122: base positioning groove; 1211: release undercut; 21: limiting guide groove; 22: front fixing groove; 23: front undercut; 24: anti-slip groove; 25: positioning ear; 26: limiting groove; 27: indicator mark; 28: large cylindrical pin, 29: small cylindrical pin; 210: front housing boss; 211: first boss; 251: fillet; 252: chamfer; 271: inner end face 271; 31: outer blade tube; 32: outer tube front sleeve; 33: inner blade tube; 321: 0-degree positioning protrusion; 322: Other positioning protrusions; 323: Features; 324: Inclined surface; 325: Outer circumferential axis; 326: Front boss of the outer sleeve; 327: Inner hole; 41: Rear fixing groove; 42: First positioning hole; 43: Second positioning hole; 44: Housing fixing groove; 45: Gasket; 46: Self-tapping screw; 47: Second boss; 48: Button fixing groove; 49: Rear housing boss; 410: Rear housing positioning groove; 51: Sample collector fixing seat; 52: Inner tube seal; 53: Integrated collection chamber; 54: Collection chamber seal; 55: Sample collector cavity; 56: Release button; 57: Spring; 58: Sample collector positioning groove; 59: Diversion groove; 510: Filter hole; 511: Positioning hole; 512: Sample collector fixing groove; 513: Sample collector boss; 521: annular fin; 522: annular gap; 523: countersunk hole; 551: cylindrical boss; 552: first strip protrusion; 553: second strip protrusion; 554: third strip protrusion; 555: guide boss; 531: sealing groove; 532: guide groove; 561: button undercut; 562: undercut boss; DETAILED DESCRIPTION

[0039] To make the purpose, technical solutions, and advantages of the embodiments of this application more clear, the technical solutions in the embodiments of this application will be clearly and completely described below in conjunction with the drawings in the embodiments of this application. Obviously, the described embodiments are part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0040] Those skilled in the art will appreciate that, unless otherwise stated, the singular forms "a," "an," "said," and "the" used herein may also include plural forms. It should be further understood that the term "comprising" used in the specification of the present invention refers to the presence of the stated features, integers, steps, operations, elements, and / or components, but does not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0041] First embodiment

[0042] As shown in Figure 1, this embodiment provides a biopsy device, including: a knife tube positioning and protection structure 1, a front shell 2, a transmission structure 3, a rear shell 4 and a sample collector structure 5; the knife tube positioning and protection structure 1 is arranged at the front end of the front shell 2, and is connected to the front shell 2 by a quick release and quick installation method; the front shell 2 is arranged at the front side of the rear shell 4, and is connected and fixed to the middle end of the biopsy device, and the transmission structure 3 is arranged inside the assembly composed of the front shell 2 and the rear shell 4; the sample collector structure 5 is arranged at the rear end of the rear shell 4, and is connected to the rear shell 4 in a coaxial and detachable manner, thereby forming a complete biopsy device.

[0043] Furthermore, as shown in Figure 2, the blade tube positioning and protection structure 1 protects the blade tube from damage and accidental injury to others in the biopsy device, and ensures that the transmission mechanism's rotational direction remains at its origin when the device is unsealed. The blade tube positioning and protection structure 1 comprises a needle sleeve 11 and a base 12. The needle sleeve 11 is positioned in front of the base 12. To prevent axial forces from acting on the needle sleeve 11, the needle sleeve 11 and base 12 are mechanically connected via an axial hole. Connection methods include, but are not limited to, gluing, tight fitting, hot melt, ultrasonic, and threaded fastening.

[0044] The shape of the needle sleeve 11 includes but is not limited to circular, oval, rectangular, polygonal, etc. The shape of the base 12 includes but is not limited to U-shaped, C-shaped, semicircular, circular, polygonal, etc. An unlocking structure 121 is provided on the base 12, and there are convex patterns on the unlocking structure 121, which makes it convenient and comfortable to use the release button 121 with your fingers. The unlocking structure 121 has plastic elasticity to ensure that the unlocking structure 121 is not unlocked in the absence of external force, so that the knife tube positioning protection structure 1 remains connected to the front shell 2. When the unlocking structure 121 is pressed, the knife tube positioning protection structure 1 is released and separated from the front shell 2. The needle sleeve 11 is made of a transparent and drop-resistant material, and its length is a certain length longer than the knife barrel of the biopsy device to ensure that it will not accidentally injure others when not in use. At the same time, the biopsy device can be visually checked for defects before use, and it can be prevented from falling and causing damage. The base 11 has an inner hole, and the inner hole has a number of grooves evenly distributed along the circumference.

[0045] As shown in Figure 3, the front shell 2 and rear shell 4 form the main frame structure of the biopsy device, which respectively supports the blade positioning and protection structure 1, the transmission structure 4, and the sample collector structure 5 from front to back. The front shell 2 includes a limiting guide groove 21, a front fixing groove 22, anti-slip grooves 24, and a positioning ear piece 25, and the rear shell 4 includes a rear fixing groove 41.

[0046] The front shell 2 is on the front side of the rear shell 4. The limiting guide grooves 21 are axially arranged on both sides of the front shell 2 to increase the strength of the front shell 2 and limit the lower shell 4 of the control handle connected to the biopsy device. The front fixing grooves 22 are arranged on the front side of the front shell 2 to connect and fix the knife tube positioning protection structure 1. The anti-slip grooves 24 are arranged at the bottom of the front shell 2 to ensure that the biopsy device will not slip during use and cause accidents. The shapes of the anti-slip grooves include but are not limited to circular, rectangular, elliptical and long strips. The positioning ear piece 25 is circumferentially arranged at one end of the front shell 2 close to the sample collector structure 5 to circumferentially limit the control handle to prevent the control handle from being horizontally misaligned when it is snapped together with the biopsy device, resulting in it being unusable. At the same time, the positioning ear piece 25 is provided with a guide angle. In this embodiment, the guide angle includes a fillet 251 and a chamfer 252, which are used to ensure that the snapping position is in place when the control handle is snapped together with the biopsy device. The rear fixing groove 41 is provided at the rear side of the rear shell 4 and is used for connecting and fixing the sample collector structure 5 .

[0047] Furthermore, the connection between the front shell 2 and the rear shell 4 is shown in FIG4 . The connection between the front shell 2 and the rear shell 4 is near the rear shell 4. The front shell 2 is a hollow cavity. The front shell 2 includes a large cylindrical pin 28, a small cylindrical pin 29, and a front shell boss 210. The rear shell 4 includes a first positioning hole 42, a second positioning hole 43, and a shell fixing groove 44.

[0048] The large cylindrical pin 28 is mechanically fixedly connected to the first positioning hole 42, and the small cylindrical pin 29 is mechanically fixedly connected to the second positioning hole 43. The shapes of the positioning holes include but are not limited to circular, polygonal (number of sides>3) and waist-shaped holes. Mechanical fixed connection includes methods such as glue filling, tight fitting, hot melting, ultrasonic and threaded fastening (gasket 45 and self-tapping screw 46) to ensure the connection strength; the front shell boss 210 is fixed with the shell fixing groove 44 in a clearance fit to ensure that the front shell 2 and the rear shell 4 will not rotate or move circumferentially. The shapes of the front shell boss 210 and the shell fixing groove 44 include but are not limited to rectangular, polygonal, long strip and various special shapes. The front shell 2 and the rear shell 4 are coaxially assembled front and back. This assembly method of the front and rear shells has high overall strength. When the biopsy device is subjected to the separation force applied by the driving handle, no separation between the shells along the vertical direction will occur.

[0049] Furthermore, the structure of the transmission structure 3 is shown in Figure 5. The transmission structure 3 is the main component of the sampling function. The transmission structure 3 includes an outer knife tube 31, an outer tube front sleeve 32 and an inner knife tube 33;

[0050] The outer tube front sleeve 32 is located at the rear side of the outer blade tube 31 and is coaxially connected to the outer blade tube 31. The outer tube front sleeve 32 and the outer blade tube 31 are coaxially and loosely engaged with each other. The inner blade tube 33 translates in the inner cavity of the outer blade tube 31 to perform the cutting surgical action. An even number of positioning protrusions are evenly distributed circumferentially on the front side of the outer tube front sleeve 32. The positioning protrusions also serve as scales to indicate the circumferential angle of the outer blade tube 31. The front sides of the positioning protrusions have inclined surfaces, which serve as guides when the blade tube positioning and protection structure 1 is assembled with the front shell 2 and the transmission structure 3. The positioning protrusions of the outer tube front sleeve 32 are coaxially engaged with the inner hole of the blade tube positioning and protection structure 1. During the production process of the biopsy device, the circumferential angle of the outer blade tube 31 is pre-set to zero when the blade tube positioning and protection structure 1 is assembled with the front shell 2 and the transmission structure 3.

[0051] As shown in FIG6 , an even number of positioning protrusions are evenly distributed circumferentially on the front side of the outer tube front sleeve 32. These positioning protrusions 321 can also serve as partial scales to indicate the circumferential angle of the outer blade tube 31. The positioning protrusions include a 0-degree positioning protrusion 321 and other positioning protrusions 322. The 0-degree scale of the 0-degree positioning protrusion 321 corresponds to the circumferential zero position of the outer blade tube 31. The front side of the 0-degree scale indicator structure has a feature 323 that distinguishes it from other angle scales. This feature is not limited to sharp corners or rounded corners. The scale marking methods include but are not limited to bosses, silk screen printing, grooves, and other marking methods. The 360-degree scale grids can be divided into but are not limited to 10°, 15°, 20°, 30°, 40°, 45°, 60°, 90°, etc. The different angle marking methods include but are not limited to color, scale shape, etc., so that the rotation angle of the outer blade tube 31 to the circumferential zero position can be easily observed after the outer blade tube 31 penetrates the tissue. A positioning protrusion 322 is also provided on the outer tube front sleeve 32, which is used to cooperate with the knife tube positioning protection structure 1 to ensure that the transmission structure 3 is at the origin. At the same time, the front side of the positioning protrusion 322 has a slope 324, which is used for guiding the assembly of the outer tube protection positioning structure 1 with the front shell 2 and the transmission structure 3.

[0052] Furthermore, the base 12 has an inner hole 327 with an even number of base positioning grooves 122 distributed along its circumference. The number of these grooves 122 is greater than the number of the outer tube front positioning protrusions 322. The inner hole 327 mates coaxially with the front boss 326 of the outer tube front sleeve. During the production process of the biopsy puncture device, the circumferential angle of the outer blade tube 31 is pre-set to zero when the outer tube protective positioning structure 1 is assembled with the front shell 2 and transmission structure 3. During surgery, the surgeon no longer needs to perform zero-position calibration using the main unit's drive handle, saving surgical time and improving zero-position accuracy.

[0053] Furthermore, the connection between the front shell 2, rear shell 4, and transmission mechanism 3 is shown in FIG7 . The front shell 2 includes a first boss 211, and the rear shell 4 includes a second boss 47. The transmission mechanism 3 is disposed within the assembly formed by the front shell 2 and the rear shell 4. The inner hole of the first boss 211 on the front shell 2 forms an axial clearance fit with the boss on the outer tube front sleeve 32, and the inner knife tube 33 forms an axial clearance fit with the inner hole of the second boss 47 on the rear shell 4, thereby enabling the transmission mechanism 3 to be supported and rotated on the front shell 2 and the rear shell 4. The first boss 211 on the front shell 2 and the second boss 47 on the rear shell 4 limit the transmission mechanism 3 forward and backward, preventing it from moving forward and backward during rotation. Furthermore, the outer tube front sleeve 32 also includes an outer circumferential surface shaft 325.

[0054] Furthermore, the connection method of the front shell 2, the transmission mechanism 3 and the knife tube positioning protection structure 1 is shown in Figures 8 and 9. The unlocking structure 121 on the base 12 is provided with a release buckle 1211, and the release buckle 1211 is engaged with the front end fixing groove 22 on the front shell 2. The engagement is maintained under the action of the plastic elastic force of the unlocking structure 121 itself to ensure the firmness of the connection.

[0055] The base 12 is also provided with a base positioning groove 122 which is clearance-matched with the positioning protrusion 322 on the outer tube front sleeve 32 to ensure that the knife tube positioning protection structure 1 is in the correct direction when inserted, and at the same time ensure that the transmission mechanism 3 cannot rotate and is located at the rotation origin when the release undercut 1211 is engaged.

[0056] When it is necessary to remove the knife tube positioning protection structure 1, press the unlocking structure 121, the unlocking structure 121 moves inward, and the release buckle 1211 is disengaged from the front end fixing groove 22, so that the knife tube positioning protection structure 1 can be pulled out. When it is necessary to put on the knife tube positioning protection structure 1, adjust the base positioning groove 122 and the positioning protrusion 322 to be in the same direction, and put the knife tube positioning protection structure 1 into the outer knife tube 31. The chamfer on the unlocking structure 121 automatically guides the release buckle 1211 into the front end fixing groove 22, and the release buckle 1211 is engaged with the front end fixing groove 22 to realize the quick disassembly and quick installation function.

[0057] Furthermore, the structure of the sample collector structure 5 is shown in FIG10 , which realizes the function of collecting biopsy samples. The sample collector structure 5 includes a sample collector fixing seat 51, an inner tube seal 52, an integrated collection chamber 53, a collection chamber seal 54, a sample collector cavity 55, a release button 56, and a spring 57;

[0058] The sample collector fixing seat 51 is arranged at the front end of the sample collector cavity 55, the inner tube seal 52 is located between the sample collector fixing seat 51 and the sample collector cavity 55, and the integrated collection chamber 53 is located at the rear end of the sample collector cavity 55 and cooperates with the sample collector cavity 55.

[0059] Furthermore, the inner tube seal 52 has an annular fin 521 at its front bottom. The fin 521 forms line contact with the outer surface of the inner tube in the absence of external forces. A certain annular gap 522 exists between the inner ring of the inner tube seal 52 and the inner tube, except for this contact. A countersunk hole 523 is located in the middle of the front side of the seal 52. During a biopsy operation, the host applies negative pressure to the inner tube. The pressure outside the inner tube is higher than inside. This high pressure outside the inner tube increases the volume of the countersunk hole 523. At this point, the annular fin 521 forms surface contact with the inner tube, acting as a seal to isolate the pressure inside and outside the inner tube. Because only a portion of the fin 521 of the inner tube seal 52 contacts the inner tube, the inner tube experiences limited resistance during axial cutting, effectively improving the efficiency of the mechanical energy input to the host control motor and ensuring the continuation of the operation. Furthermore, because the inner tube seal contacts the inner tube only within the fin portion, the resistance exerted by the seal on the inner tube is effectively reduced, improving the efficiency of the host control motor.

[0060] The collecting chamber seal 54 is placed in the sealing groove 531 on the integrated collecting chamber 53, and is used to be squeezed when the sample collector cavity 55 and the integrated collecting chamber 53 are matched, thereby achieving the sealing performance of the sample collector cavity 55 and ensuring that the integrated collecting chamber 53 does not shake when fixed to the sample collector cavity 55;

[0061] The release button 56 and the spring 57 are installed on both sides of the sample collector fixing seat 51, and the sample collector fixing seat 51 is mechanically connected to the several cylindrical bosses on the sample collector cavity 55 through several positioning holes; in this embodiment, it includes four positioning holes 511 and four cylindrical bosses 551, and the shape of the positioning hole 511 includes but is not limited to circle, polygon (number of sides>3), etc., and the connection method includes but is not limited to glue filling, tight fit, hot melt, ultrasonic and threaded fastening, etc., to ensure that the connection between the two is firm.

[0062] The inner mesh sealing gasket 52 is coaxially arranged with the sample collecting chamber 55 and is connected with the sample collecting chamber 55 by mechanical means including but not limited to glue filling to ensure its firmness and sealing.

[0063] The button buckle 561 on the release button 56 is engaged with the sample collector fixing groove 512 on the sample collector fixing seat 51. The spring 57 uses elastic force to ensure that the button buckle 561 is always engaged when there is no external force acting on the spring 57. The sample collector fixing groove 512 ensures that the release button 56 moves in a specified direction.

[0064] The sample collector cavity 55 is fitted with the integrated collection bin 53. The inner wall of the upper volume of the sample collector cavity 55 has a number of strip-shaped protrusions at a certain interval. The distance between two adjacent strip-shaped protrusions is less than the diameter of a single tissue strip and greater than half of the diameter of a single tissue strip. The strip-shaped protrusions with such a spacing can effectively prevent the splines that fall from the inner tube into the collection bin from adhering to the inner wall of the sample collector cavity 55. In this embodiment, the strip-shaped protrusions include a first strip-shaped protrusion 552, a second strip-shaped protrusion 553, and a third strip-shaped protrusion 554. The number of strip-shaped protrusions can be flexibly set, including but not limited to 3.

[0065] There are guide grooves 532 on both sides of the integrated collecting bin 53, which are clearance-matched with the guide bosses 555 on the sample collector cavity 55. At the same time, the combined action of the strip-shaped protrusions realizes the guiding effect when the integrated collecting bin 53 enters the sample collector cavity 55, thereby preventing the integrated collecting bin 53 from rotating.

[0066] In addition, the sample collector structure 5 also includes a guide groove 59 to facilitate the removal of blood and water. The integrated collection chamber structure includes a plurality of filter holes 410, which are present on the bottom surface and the front end surface of the collection chamber. The diameter of the filter hole 410 is just enough to retain the blood in the inner cavity of the collection chamber when there is no external force, so as to prevent the blood from flowing out of the filter hole 410 to the outside during the process of removing the spline tissue after the operation, causing pollution to the operating room environment. At the same time, in the case of negative pressure suction, the blood in the collection chamber can flow out of the filter hole 410 to the waste liquid collection tube to separate the spline tissue from the blood, and prevent the blood from accumulating in the collection chamber and affecting the adsorption effect.

[0067] Furthermore, the integrated sample collection chamber is arranged on the inner end face 271 of the sample collector cavity and is designed as a dome-shaped convex surface, with the most convex point located above the axis of the inner tube, which can prevent the spline tissue flowing out from the tail of the inner tube from adhering to the end face 271, thereby affecting the subsequent negative pressure adsorption effect.

[0068] Furthermore, as shown in FIG11 , the inverted boss 562 on the release button 56 is engaged with the button fixing groove 48 on the rear shell 4, and the elastic force of the spring 57 is used to ensure that the inverted boss 562 will not separate from the button fixing groove 48 when no external force acts on the spring 57, thereby ensuring that the sample collector structure 5 is firmly connected to the rear shell 4 and does not fall off.

[0069] The rear shell boss 49 on the rear shell 4 is clearance-fitted with the sample collector positioning groove 58 on the sample collector fixing seat 51, and the rear shell positioning groove 410 on the rear shell 4 is clearance-fitted with the sample collector boss 513 on the sample collector fixing seat 51;

[0070] When it is necessary to remove the sample collector structure 5, press and hold the release button 56, the spring 57 is compressed, and the inverted boss 562 is disengaged from the button fixing groove 48, so that the sample collector structure 5 can be pulled out. When it is necessary to install the sample collector structure 5, press and hold the release button 56, adjust the directions of the rear shell boss 49 and the sample collector positioning groove 58, as well as the rear shell positioning groove 410 and the sample collector boss 513 to be consistent, install the sample collector structure 5 into the rear shell 4, release the release button 56, the spring 57 rebounds, and the inverted boss 562 engages with the button fixing groove 48, thereby realizing quick disassembly and quick installation.

[0071] The above description is merely a preferred embodiment of the present invention. The scope of protection of the present invention is not limited to the above embodiment. All technical solutions based on the concept of the present invention are within the scope of protection of the present invention. It should be noted that for those skilled in the art, various improvements and modifications that do not depart from the principles of the present invention should also be considered within the scope of protection of the present invention.

[0072] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

Claims

1. A biopsy device, characterized in that: include: Knife tube positioning protection structure, front shell, transmission structure, rear shell and sample collector structure; The knife tube positioning protection structure is arranged at the front end of the front shell and is connected to the front shell by a quick release and quick installation method; The front shell is arranged at the front side of the rear shell and is connected and fixed to the middle end of the biopsy device, and the transmission structure is arranged inside the assembly composed of the front shell and the rear shell; The sample collector structure is arranged at the rear end of the rear shell and is connected to the rear shell in a coaxial detachable manner.

2. The biopsy device according to claim 1, characterized in that: The knife tube positioning protection structure includes a needle sleeve and a base; The needle sleeve is arranged on the front side of the base, and the needle sleeve and the base are connected by an axial hole matching mechanical connection method including glue injection, tight fit, hot melt, ultrasonic and thread fixation; The base is provided with an unlocking structure, which has plastic elasticity to ensure that the unlocking structure is not unlocked without external force, so that the knife tube positioning protection structure remains connected to the front shell, and when the unlocking structure is pressed, the knife tube positioning protection structure is released to separate from the front shell; The base has an inner hole, and the inner hole has a plurality of grooves evenly distributed along the circumference.

3. The biopsy device according to claim 1, characterized in that: The transmission structure comprises an outer knife tube, an outer tube front sleeve and an inner knife tube; The outer tube front sleeve is located at the rear side of the outer knife tube, and at the same time, the outer tube front sleeve is coaxially connected to the outer knife tube, and the outer tube front sleeve and the outer knife tube are coaxially matched with each other, and the inner knife tube translates in the inner cavity of the outer knife tube to realize the cutting surgical action; An even number of positioning protrusions are evenly arranged on the front side of the outer tube front sleeve in the circumferential direction, and the positioning protrusions also serve as scales to indicate the circumferential angle of the outer knife tube. The front side of the positioning protrusions has an inclined surface, which serves as a guide when the knife tube positioning protection structure is assembled with the front shell and the transmission structure. The positioning protrusion of the front sleeve of the outer tube is coaxially matched with the inner hole of the knife tube positioning protection structure. During the production process of the biopsy device, the circumferential angle of the outer knife tube is pre-installed to zero position when the knife tube positioning protection structure is assembled with the front shell and the transmission structure.

4. The biopsy device according to claim 2, characterized in that: Also includes: The unlocking structure on the base is provided with a release undercut, and the release undercut is engaged with the front fixing groove on the front shell, and is kept engaged under the plastic elastic force of the unlocking structure itself; The base is also provided with a base positioning groove which is clearance-matched with the positioning protrusion on the front sleeve of the outer tube, so as to ensure that the knife tube positioning protection structure is in the correct direction when inserted, and at the same time ensure that the transmission mechanism cannot rotate and is located at the rotation origin when the undercut buckle is released; When it is necessary to remove the knife tube positioning protection structure, press the unlocking structure, the unlocking structure moves inward, the release undercut is disengaged from the front end fixing groove, so that the knife tube positioning protection structure can be pulled out; when it is necessary to put on the knife tube positioning protection structure, adjust the base positioning groove and the positioning protrusion to be in the same direction, put the knife tube positioning protection structure into the outer knife tube, and the chamfer on the unlocking structure automatically guides the release undercut into the front end fixing groove, and the release undercut is buckled with the front end fixing groove to realize the quick release and quick installation function.

5. The biopsy device according to claim 1, characterized in that: The front shell includes a limiting guide groove, a front fixing groove, an anti-slip pattern, and a positioning ear piece, and the rear shell includes a rear fixing groove; The limiting guide grooves are axially arranged on both sides of the front shell, and are used to increase the strength of the front shell and limit the lower shell of the control handle connected to the biopsy device; The front end fixing groove is arranged at the front side of the front shell, and is used for connecting and fixing the knife tube positioning protection structure; The anti-slip pattern is arranged at the bottom of the front shell to ensure that the biopsy device will not slip when in use, causing an accident; The positioning ear piece is circumferentially arranged at one end of the front shell close to the sample collector structure, and is used to limit the control handle circumferentially to prevent the control handle from being horizontally misaligned when being buckled with the biopsy device, resulting in inability to use. At the same time, a guide angle is arranged on the positioning ear piece, and is used to ensure that the buckling position is in place when the control handle is buckled with the biopsy device; The rear end fixing groove is arranged at the rear side of the rear shell and is used for connecting and fixing the sample collector structure.

6. The biopsy device according to claim 1, characterized in that: The front shell includes a large cylindrical pin, a small cylindrical pin and a front shell boss, and the rear shell includes a first positioning hole, a second positioning hole and a shell fixing groove; The large cylindrical pin is mechanically fixedly connected to the first positioning hole, and the small cylindrical pin is mechanically fixedly connected to the second positioning hole, wherein the mechanical fixed connection includes methods such as glue injection, tight fit, hot melt, ultrasonic and threaded fastening; The front shell boss is fixed with the housing fixing groove by clearance fit, ensuring that the front shell and the rear shell will not rotate or move in the circumferential direction.

7. The biopsy device according to claim 1, characterized in that: The front shell includes a first boss, and the rear shell includes a second boss; The transmission structure is arranged inside the assembly composed of the front shell and the rear shell, the inner hole of the first boss on the front shell is matched with the boss existing on the front sleeve of the outer tube in an axial hole clearance, and the inner knife tube is matched with the inner hole of the second boss on the rear shell in an axial hole clearance, so as to realize the support and rotation of the transmission mechanism on the front shell and the rear shell; The first boss on the front shell and the second boss on the rear shell limit the transmission structure forward and backward to prevent the transmission structure from moving forward and backward during rotation.

8. The biopsy device according to claim 1, characterized in that: The sample collector structure includes a sample collector fixing seat, an inner tube seal, an integrated collection bin, a collection bin seal, a sample collector cavity, a release button, and a spring; The sample collector fixing seat is arranged at the front end of the sample collector cavity, the inner tube sealing member is located between the sample collector fixing seat and the sample collector cavity, and the integrated collection bin is located at the rear end of the sample collector cavity and cooperates with the sample collector cavity; The collection bin seal is placed in a seal groove on the integrated collection bin, and is used to be squeezed when the sample collector cavity is matched with the integrated collection bin, thereby achieving the sealing performance of the sample collector cavity, and ensuring that the integrated collection bin does not shake when it is fixed on the sample collector cavity; The release button and the spring are mounted on both sides of the sample collector fixing seat, and the sample collector fixing seat is mechanically connected to a plurality of cylindrical bosses on the sample collector cavity through a plurality of positioning holes; The inner mesh seal has an annular fin at the bottom of the front side, and the annular fin is in line contact with the outer surface of the inner tube without external force. In addition to the line contact, there is an annular gap between the inner ring of the inner mesh seal and the inner tube. The inner mesh seal has a countersunk hole in the middle of the front side, and the countersunk hole is used to change the volume of the countersunk hole when the pressure on both sides of the inner mesh seal and the inner tube cut surface is uneven, thereby increasing the sealing performance between the inner mesh seal and the inner tube cut surface; The button buckle on the release button is engaged with the sample collector fixing groove on the sample collector fixing seat, and the spring uses elastic force to ensure that the button buckle is always engaged when there is no external force acting on the spring, and the sample collector fixing groove ensures that the release button moves in a specified direction.

9. The biopsy device according to claim 8, characterized in that: Also includes: The sample collector cavity is fitted with the integrated collection bin, and there are a number of strip-shaped protrusions on the sample collector cavity, which are used to prevent the top of the sample collector cavity from sticking to the sample. The strip-shaped protrusion fits into the groove, and the sample accidentally stuck is scraped off to obtain a complete sample; There are guide grooves on both sides of the integrated collection bin, which cooperate with the guide bosses on the sample collector cavity. At the same time, the strip protrusions work together to achieve the guiding effect when the integrated collection bin enters the sample collector cavity, preventing the integrated collection bin from rotating.

10. The biopsy device according to claim 8, characterized in that: Also includes: The undercut boss on the release button is engaged with the button fixing groove on the rear shell, and the elastic force of the spring is used to ensure that the undercut boss will not be separated from the button fixing groove when no external force acts on the spring, thereby ensuring that the sample collector structure is firmly connected to the rear shell and does not fall off; The rear shell boss on the rear shell and the sample collector positioning groove on the sample collector fixing seat are clearance-matched, and the rear shell positioning groove on the rear shell and the sample collector boss on the sample collector fixing seat are clearance-matched; When it is necessary to remove the sample collector structure, the release button is pressed, the spring is compressed, the inverted boss is disengaged from the button fixing groove, and the sample collector structure can be pulled out. When it is necessary to install the sample collector structure, the release button is pressed, the rear shell boss and the sample collector positioning groove, as well as the rear shell positioning groove and the sample collector boss are adjusted to be consistent in direction, the sample collector structure is installed into the rear shell, the release button is released, the spring rebounds, the inverted boss is buckled with the button fixing groove, and quick disassembly and installation are achieved.

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