CN116407160A

CN116407160A - Biopsy device

Info

Publication number: CN116407160A
Application number: CN202111640767.7A
Authority: CN
Inventors: 李恒; 夏清松; 胡龙虎; 李安宁
Original assignee: Shenzhen Lifetech Respiration Scientific Co Ltd
Current assignee: Shenzhen Lifetech Respiration Scientific Co Ltd
Priority date: 2021-12-29
Filing date: 2021-12-29
Publication date: 2023-07-11
Also published as: WO2023125356A1

Abstract

The invention is applicable to the field of medical instruments, and provides a biopsy device which comprises a shell, a suction assembly, a pushing assembly and a sensing assembly, wherein the suction assembly comprises a needle tube capable of moving along the axial direction, the needle tube penetrates through the shell, the distal end of the needle tube can extend out of the distal end of the shell, and part of the sensing assembly is connected with the pushing assembly and the needle tube so that the sensing assembly can detect and feed back the pressure applied to the needle tube in the process that the pushing assembly drives the needle tube to push towards a target tissue. According to the biopsy device provided by the invention, in the process that the pushing component drives the needle tube to push to the target tissue, the sensing component can detect and feed back the resistance born by the needle tube, and an operator can know the current puncture condition of the needle tube according to the feedback of the sensing component, so that the operation precision and the safety can be improved.

Description

Biopsy device

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to a biopsy device.

Background

Tissue tumor is a disease seriously damaging human health and life, and in recent years, the incidence rate gradually increases and the incidence age gradually decreases, so that the tissue tumor is of great significance for early and accurate diagnosis. The correct diagnosis requires three combinations of clinic, image and pathology, wherein the pathological diagnosis plays a key role in the selection of a treatment scheme, and the puncture biopsy is a main way for obtaining a tissue sample.

The main sampling instrument used in the operation process is a biopsy needle, which is used as a qualified biopsy needle, and the most basic requirement is accurate positioning and safe operation, so that the operation can be successfully performed, and the safety of the patient and medical staff in the operation process is ensured.

Biopsy devices are currently commonly used needle biopsy devices. The needle insertion of the traditional biopsy device is monitored only by an endoscope, whether the needle tube of the biopsy device is penetrated into a target tissue or not is difficult to observe, the biopsy device can be judged only by the feeling and experience of operators, the requirements on the operators are high, certain probability of needle insertion failure exists, and the safety is poor.

Disclosure of Invention

The invention aims to provide a biopsy device, which aims to solve the technical problems that the biopsy device in the prior art has too high requirements on operators and has poor safety.

The biopsy device comprises a shell, a suction assembly, a pushing assembly and a sensing assembly, wherein the suction assembly comprises a needle tube capable of moving along the axial direction, the needle tube penetrates through the shell, the distal end of the needle tube can extend out of the distal end of the shell, the sensing assembly is connected with the pushing assembly and the needle tube, the sensing assembly can detect and feed back whether the resistance of the needle tube exceeds a threshold value or not in the process that the pushing assembly drives the needle tube to push to target tissues.

The beneficial effects of the invention are as follows: the biopsy device provided by the invention comprises a shell, a suction assembly, a pushing assembly and a sensing assembly, wherein the suction assembly comprises a needle tube capable of moving along the axial direction, the sensing assembly can detect and feed back the resistance born by the needle tube in the process that the pushing assembly drives the needle tube to push towards a target tissue, and an operator can know the current puncture condition of the needle tube according to the feedback of the sensing assembly so as to improve the operation precision and the safety.

Drawings

FIG. 1 is a perspective view of a biopsy device provided in a first embodiment of the present invention;

FIG. 2 is an exploded view of the biopsy device of FIG. 1;

FIG. 3 is a perspective view of the sensing element of FIG. 2;

FIG. 4 is an enlarged view of a portion of FIG. 2 at A;

FIG. 5 is a vertical cross-sectional view of the biopsy device of FIG. 1;

FIG. 6 is an enlarged view of a portion at B of FIG. 5;

FIG. 7 is an enlarged view of a portion at C of FIG. 5;

FIG. 8 is a partial enlarged view at D of FIG. 5;

FIG. 9 is a perspective view of a biopsy device provided in a second embodiment of the present invention;

FIG. 10 is an exploded view of the biopsy device of FIG. 9;

FIG. 11 is a vertical cross-sectional view of the biopsy device of FIG. 9;

FIG. 12 is an enlarged view of a portion of FIG. 10 at E;

fig. 13 is a schematic diagram of a display unit arrangement according to a third embodiment of the present invention.

The reference numerals in the drawings are as follows:

100. a biopsy device;

110. a housing;

120. a suction assembly; 121. a needle tube; 1211. a protruding portion; 122. a needle sleeve; 123. a needle core; 124. a fixed block;

130. a propulsion assembly; 131. a first rotating member; 132. a pushing member; 1321. a positioning groove; 1322. a first glue injection port; 1323. a via hole; 133. a thread structure; 1331. an internal thread; 1332. an external thread; 134. a first connector;

140. an induction assembly; 141. an induction member; 1411. a fixing part; 1412. an elastic part; 1413. a glue injection groove; 142. a display unit;

150. a bending adjustment assembly; 151. a traction member; 152. a second rotating member; 153. a pulling member; 1531. a placement groove; 1532. a second glue injection port; 1535. a via hole; 154. a pressing member; 1541. a via hole; 1542. an auxiliary groove; 155. a thread structure; 1551. an internal thread; 1552. an external thread;

160. a sealing structure; 161. a first fixing member; 1611. a via hole; 162. a second fixing member; 1621. a mating groove; 163. a second connector; 164. an extrusion; 165. a seal; 166. a thread structure; 1661. an internal thread; 1662. and (5) external threads.

Detailed Description

In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit or scope of the invention, which is therefore not limited to the specific embodiments disclosed below.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

In the field of interventional medical devices, "distal" is defined as the end of the procedure that is distal to the operator, and "proximal" is defined as the end of the procedure that is proximal to the operator. "axial" refers to a direction parallel to the line connecting the distal center and the proximal center of the medical device, and "radial" refers to a direction perpendicular to the axial direction.

As shown in fig. 1 and 2, a biopsy device 100 is provided in accordance with a first embodiment of the present invention. The biopsy device 100 is used to pierce a human body to extract living tissue of the human body, and specifically, the biopsy device is not limited to the piercing of bronchi, liver, kidney, lymph nodes, and the like to extract tissue. In this embodiment, the biopsy device 100 is described by taking as an example that the bronchial wall is pierced.

As shown in fig. 1, 2 and 5, biopsy device 100 includes a housing 110, a suction assembly 120, a pusher assembly 130, and a sensing assembly 140. The aspiration assembly 120 includes an axially movable needle cannula 121, the needle cannula 121 being insertable through the housing 110. The distal end of needle cannula 121 can extend from the distal end of housing 110 to penetrate into tissue. Needle cannula 121 is hollow to allow target tissue to pass through needle cannula 121 into a negative pressure device (not shown) coupled to biopsy device 100. Part of the sensing assembly 140 may be connected to the pushing assembly 130 and the needle tube 121, so that the sensing assembly 140 can detect and feedback the resistance of the needle tube 121 during the pushing process of the pushing assembly 130 driving the needle tube 121 to the target tissue.

The biopsy device 100 operates generally as follows:

when the distal end of needle cannula 121 is continuously increasing in pressure against the bronchial wall but has not yet penetrated the bronchial wall, sensing assembly 140 detects that the resistance experienced by needle cannula 121 exceeds a preset threshold. At this point, sensing assembly 140 will feed back to the operator that needle cannula 121 is not penetrating the bronchial wall, indicating that the operator may continue needle insertion.

When the distal end of needle cannula 121 penetrates the bronchial wall, sensing assembly 140 detects that the resistance experienced by needle cannula 121 is below a preset threshold. At this point, sensing assembly 140 will feed back to the operator that needle cannula 121 has penetrated the bronchial wall, indicating that the operator may stop needle insertion.

In summary, compared to the prior art, the biopsy device 100 has at least the following advantages:

in the process that the pushing component 130 drives the needle tube 121 to push toward the target tissue, the sensing component 140 can detect and feed back the resistance born by the needle tube 121, and an operator can know the current puncture condition of the needle tube 121 according to the feedback of the sensing component 140, so that the operation precision and the safety can be improved.

In this embodiment, as shown in FIG. 2, the aspiration assembly 120 further includes a needle hub 122 disposed through the distal end of the housing 110. The distal end of the needle hub 122 may protrude beyond the distal end of the housing 110. The distal end of the needle cannula 121 is received within the needle hub 122 before the needle cannula 121 is controlled to pierce the bronchial wall. The needle tube 121 is axially movably inserted through the needle sheath 122.

In this embodiment, as shown in fig. 2, the aspiration assembly 120 further includes a stylet 123. The needle core 123 may axially penetrate the needle tube 121 and fill the interior cavity of the needle tube 121. The presence of the core 123 prevents other non-target tissue from entering the lumen of the needle cannula 121 during penetration of the needle cannula 121 into the body and before reaching the area of the bronchi having the target tissue, improving the success rate of the biopsy. After the needle tube 121 reaches the region of the bronchus having the target tissue, the target tissue is suctioned by withdrawing the core 123 from the needle tube 121.

In this embodiment, a fixed block 124 (see FIG. 6) may be attached to the proximal end of the needle cannula 121, the fixed block 124 being used to fixedly attach the needle cannula 121 to the sensing assembly 140. And, the proximal end of the needle tube 121 protrudes from the proximal end face of the fixed block to form a protruding portion 1211. The protrusion 1211 may be received in a hole of the sensing element 140. In the present embodiment, as shown in fig. 1, 2, 5 and 6, the propulsion assembly 130 includes a propulsion member 132 and a first rotation member 131. The pushing member 132 may have a block-shaped structure, and the first rotating member 131 may have a hollow cylindrical structure. The pushing member 132 may be located in the first rotating member 131, and the pushing member 132 may be rotatably connected to the first rotating member 131. Specifically, the first rotation member 131 rotates to drive the pushing member 132 to move in the axial direction. Needle cannula 121 may be coupled to a pusher 132. In this embodiment, the first rotating member 131 and the pushing member 132 rotate relatively to enable the pushing member 132 to move in the axial direction. The pushing member 132 moves in the axial direction to drive the needle tube 121 to move in the axial direction. The axial distal movement of the pusher 132 causes the distal end of the needle cannula 121 to penetrate the bronchial wall.

In this embodiment, as shown in fig. 2, the proximal end of the pushing member 132 may be provided with a first connecting member 134, and the proximal end of the first connecting member 134 may axially extend out of the housing 110. The first connecting member 134 has a hollow structure, and the lumen of the first connecting member 134 communicates with the lumen of the needle tube 121. The proximal end of the first connector 134 is adapted to be connected to a negative pressure device (not shown) to facilitate negative pressure operation of the needle cannula 121.

In the present embodiment, as shown in fig. 2 and 6, a screw structure 133 may be provided between the pushing member 132 and the first rotating member 131. The pushing member 132 and the first rotating member 131 are rotatably coupled by a screw structure 133. The screw structure 133 may connect the pushing member 132 with the first rotating member 131, and the pushing member 132 may move in an axial direction when the pushing member 132 rotates relative to the first rotating member 131. The thread structure 133 includes an internal thread 1331 and an external thread 1332 that mates with the internal thread 1331. The internal thread 1331 may be provided on the inner wall of the first rotation member 131, and the external thread 1332 may be provided on the circumferential wall of the pushing member 132. Alternatively, the internal thread 1331 may be provided on the circumferential wall of the pushing member 132, and the external thread 1332 may be provided on the inner wall of the first rotation member 131. Further, the first rotating member 131 may be sleeved on the housing 110, and the external thread 1332 may penetrate through the housing 110 in a radial direction and be in threaded engagement with the internal thread 1331.

In this embodiment, as shown in FIGS. 2, 5 and 6, the sensing assembly 140 includes a sensing element 141, and the sensing element 141 may be located within the housing 110 and disposed between the proximal end of the needle cannula 121 and the pushing element 132. The sensing member 141 can detect the resistance of the needle tube 121 during the process that the pushing member 132 drives the needle tube 121 to advance toward the target tissue. It will be appreciated that as the distal end of needle cannula 121 continues to exert increasing pressure against the bronchial wall to abut the bronchial wall but not yet penetrate the bronchial wall, the reaction force (i.e., resistance) experienced by needle cannula 121 will be exerted on sensing element 141 and will continue to increase beyond the predetermined threshold, i.e., sensing element 141 will detect that the resistance experienced by needle cannula 121 exceeds the predetermined threshold. When the distal end of needle cannula 121 penetrates the bronchial wall, sensing assembly 140 detects that the resistance force experienced by needle cannula 121 is below a predetermined threshold, and the reaction force experienced by needle cannula 121 is applied to sensing element 141 and continuously decreases below the predetermined threshold, i.e., sensing element 141 detects that the pressure experienced by needle cannula 121 is below the predetermined threshold.

In the present embodiment, as shown in fig. 3 and 6, the sensing element 141 includes a fixing portion 1411, an elastic portion 1412, and a through hole 1415 penetrating the fixing portion 1411 and the elastic portion 1412. The fixing portion 1411 may be fixedly connected to the pushing member 132, and may be fixed by injecting glue at a contact surface of the fixing portion 1411 and the pushing member 132. The elastic portion 1412 may be disposed at a distal end of the fixing portion 1411, and the elastic portion 1412 is fixedly connected to a portion of the edge of the fixing portion 1411. And a gap 1417 communicating with the through hole 1415 may be provided between the edge of the portion where the elastic portion 1412 and the fixing portion 1411 are not connected, so that when the elastic portion 1412 is pressed, the elastic portion 1412 can slightly deviate from the fixing portion 1411 in the axial direction, and thus the resistance of the detector is easier. The proximal end of needle cannula 121 may be fixedly coupled to resilient portion 1412. The protruding portion 1211 of the needle tube 121 is accommodated in the through hole 1415, and the proximal end of the protruding portion 1211 is closer to the proximal end of the fixing portion 1411 than the gap 1417, so that blood, tissue, or the like is prevented from entering the gap 1417 during the suction process, thereby improving the sensing efficiency of the sensing element 141. The needle tube 121 is subjected to resistance to penetrate the target tissue to drive the elastic portion 1412 to deflect in the axial direction relative to the fixed portion 1411, so that the amount of resistance to the needle tube 121 is detected based on the amount of deflection thereof. In other embodiments, the fixing portion 1411 and the pushing member 132 may be connected together by a screw connection, a clamping connection, or other suitable manners, which is not limited to the glue bonding in this embodiment.

In this embodiment, as shown in fig. 3 and 6, the distal end of the pushing member 132 may be provided with a positioning groove 1321. The fixing portion 1411 can be accommodated in the positioning groove 1321, so as to prevent the fixing portion 1411 from being deflected in the radial direction when receiving the axial pressure, and improve the detection accuracy of the sensing element 141. The proximal end of the fixing portion 1411 may be fixedly coupled to the bottom of the positioning groove 1321. Further, in order to prevent the adhesive from directly injecting onto the proximal end surface of the fixing portion 1411 and the bottom of the positioning groove 1321, which causes the adhesive to overflow from the side of the fixing portion 1411, so that the elastic portion 1412 is fixedly connected with the pushing member 132 and cannot be elastically deformed, the proximal end surface of the fixing portion 1411 may be provided with an injecting groove 1413, and the adhesive may be injected into the injecting groove 1413.

The pushing member 132 may be provided with a first glue injection port 1322 disposed along a radial direction, and the first glue injection port 1322 may be communicated with the positioning slot 1321. The first glue injection port 1322 may be disposed corresponding to a mating position between the proximal end surface of the fixing portion 1411 and the bottom of the positioning groove 1321, so that after the proximal end surface of the fixing portion 1411 contacts with the bottom of the positioning groove 1321, the adhesive is injected into the positioning groove 1321 from the first glue injection port 1322, so that the fixing portion 1411 is better fixedly connected with the pushing member 132.

In this embodiment, as shown in fig. 1 and 2, the sensing assembly 140 further includes a display unit 142. The display unit 142 may be disposed outside the housing 110, specifically, disposed on the housing 110. The display unit 142 is electrically connected to the sensing element 141, and is configured to reflect whether or not the magnitude of the resistance force received by the needle tube 121 detected by the sensing element 141 exceeds a threshold value.

In the present embodiment, the display unit 142 may be an indicator lamp that can be turned on or off. It will be appreciated that the indicator light will illuminate when the sensing element 141 detects that the resistance experienced by the needle cannula 121 exceeds a preset threshold. When sensing element 141 detects that the resistance of needle cannula 121 is below a preset threshold, the indicator light will go off. I.e. the operator is prompted by the turning on and off of the indicator light of the penetration of the bronchial wall by the needle cannula 121.

In this embodiment, as shown in fig. 1 and 2, since some target tissues are located in a position where the bronchi are curved, it is difficult to align the linear needle sheath 122 with the target tissues. Based thereon, the biopsy device 100 further comprises a bending assembly 150 for bending the distal end of the needle hub 122 to enable the distal end of the needle hub 122 to be aligned with the target tissue as described above. Further, the degree of curvature of the distal end of the needle hub 122 can also be adjusted depending on the specific location of the target tissue of the bronchi.

In this embodiment, as shown in fig. 2, 5 and 8, the bending assembly 150 includes a traction member 151. The distal end of the pulling member 151 may be disposed through the wall of the needle hub 122 and secured to the distal end of the needle hub 122. The proximal end of the pulling member 151 may extend out of the needle hub 122 from within the wall of the needle hub 122 and be positioned within the housing 110. The traction member 151 may be nickel titanium wire. Pulling on the proximal end of the pulling member 151 causes the distal end of the needle hub 122 to bend. And, the degree of bending of the distal end of the needle hub 122 can be adjusted by controlling the force of pulling the pulling member 151.

In this embodiment, as shown in fig. 2, 4, 5 and 8, the bending assembly 150 further includes a second rotating member 152 and a pulling member 153. The pulling member 153 may be located within the housing 110 and fixedly coupled to the proximal end of the pulling member 151. The second rotating member 152 is sleeved on the housing 110 and is rotatably connected to the pulling member 153. When the second rotating member 152 rotates relative to the pulling member 153, the second rotating member 152 can drive the pulling member 153 to move along the axial direction. When the pulling member 153 moves toward the proximal end of the housing 110, the pulling member 151 is driven to pull the distal end of the needle hub 122 to bend. It will be appreciated that the closer the pulling member 153 is to the proximal end of the housing 110, the greater the force with which the pulling member 151 is pulled, and the greater the force with which the pulling member 151 pulls the distal end of the needle hub 122, the greater the degree of bending of the distal end of the needle hub 122.

In the present embodiment, as shown in fig. 2 and 8, a screw structure 155 may be provided between the second rotation member 152 and the pulling member 153. The second rotation member 152 and the pulling member 153 may be connected by a screw structure 155. The threaded structure 155 includes an internal thread 1551 and an external thread 1552 that mates with the internal thread 1551. In this embodiment, as shown in fig. 2, 4, 5 and 8, the bending assembly 150 further includes a pressing member 154 radially inserted into the pulling member 153. One side of the pulling member 153 along the axial direction may be provided with a placement groove 1531, and the placement groove 1531 may be disposed along a direction perpendicular to the axial direction. The placement groove 1531 may be a cylindrical groove, and correspondingly, the pressing member 154 may be cylindrical such that the pressing member 154 can rotate relative to the pulling member 153. The pulling member 153 is provided with a through hole 1535 for the pulling member 151 to pass through, and the through hole 1535 may axially penetrate the proximal end face and the distal end face of the pulling member 153. The pressing member 154 may be provided with a via 1541 for passing the pulling member 151 therethrough, and the via 1541 may penetrate a side surface of the pressing member 154 in a radial direction of the pressing member 154. An auxiliary groove 1542 is formed at an end of the pressing member 154 facing the outside of the housing 110, so that after the pressing member 154 is inserted into the placement groove 1531 of the pulling member 153, a screwdriver can be inserted into the auxiliary groove 1542, and the screwdriver can be rotated to drive the pressing member 154 to rotate. The auxiliary groove 1542 may be a straight groove or a cross groove. It should be understood that the placement groove 1531 may be provided in other directions, and is not limited to this embodiment, for example, a portion of the upper surface of the pulling member 153 in fig. 2 is recessed toward the inside of the pulling member 153 to form a placement groove, so long as the placement groove is communicated with the via hole of the pulling member, and the pulling member can pass through the via hole of the pressing member accommodated in the placement groove to connect the pulling member and the pulling member.

During assembly of the buckle assembly 150, the compression member 154 is inserted into the placement slot 1531 and the via 1541 on the compression member 154 is brought into abutment and communication with the via 1535 on the pull member 153. The proximal end of the pulling member 151 is passed through the through hole 1541 in the pulling member 153 and the through hole 1541 in the pressing member 154 and then extends from the pulling member 153 toward the proximal end of the housing 110. Rotation of the hold-down member 154 causes the pulling member 151 to wrap around the hold-down member 154 such that the proximal end of the pulling member 151 is fixedly coupled to the pulling member 153.

In this embodiment, a thread structure (not shown) similar to the thread structure 155 may be provided between the pressing member 154 and the pulling member 153. The pressing member 154 and the pulling member 153 may be fixedly coupled by the similar screw structure. A similar thread structure comprises an internal thread and an external thread adapted to the internal thread. The internal thread may be located in the placement groove 1531 and provided on the inner wall of the pulling member 153, and the external thread may be provided on the peripheral wall of the pressing member 154. Alternatively, the internal thread may be provided on the circumferential wall of the pressing member 154, and the external thread may be provided in the placement groove 1531 and on the inner wall of the pulling member 153.

In this embodiment, as shown in fig. 8, the gap between the pressing member 154 and the pulling member 153 may be filled with glue, so that the proximal end of the pulling member 151 wound around the pressing member 154 is more firmly connected to the pushing member 132. Further, the pulling member 153 may be provided with a second glue injection port 1532 disposed along a radial direction, and the second glue injection port 1532 may be in communication with the placement groove 1531 (see fig. 4). After the proximal end of the pulling member 151 is wound around the pressing member 154, an adhesive is injected into the placement groove 1531 from the second adhesive injection port 1532, so that the proximal end of the pulling member 151, the pressing member 154 and the pulling member 153 are fixedly connected.

In this embodiment, the proximal end of the pulling member 151 extends axially through the length of the compression member 154 greater than or equal to one-half the circumference of the side wall of the compression member 154 so that the proximal end of the pulling member 151 does not become dislodged from the compression member 154 after rotation of the compression member 154 and is securely wrapped around the compression member 154.

In this embodiment, as shown in fig. 4, a sealing structure 160 may be disposed between the pushing assembly 130 and the bending assembly 150 to prevent tissue cells, liquid, etc. from entering the housing 110 from the proximal end of the needle sheath 122, thereby effectively improving the efficiency of use of the biopsy device 100.

In the present embodiment, as shown in fig. 2, 4, 5 and 7, the sealing structure 160 includes a first fixing member 161, a second fixing member 162, an extrusion 164 and a sealing member 165. The first anchor 161 may be located at the proximal end of the needle hub 122. The first fixing member 161 and the second fixing member 162 are fixedly coupled to the housing 110. The first fixing member 161 and the second fixing member 162 may each have a block shape. A second connecting member 163 may be disposed between the first fixing member 161 and the second fixing member 162, and both ends of the second connecting member 163 are connected to the proximal end of the first fixing member 161 and the distal end of the second fixing member 162, respectively. The second connection member 163 may have a tubular structure disposed in an axial direction. That is, propulsion assembly 130 is disposed proximate the proximal end of housing 110 and bending assembly 150 is disposed proximate the distal end of housing 110. The proximity of the pusher assembly 130 to the proximal end of the housing 110 can facilitate operator control of needle insertion. The bending assembly 150 is positioned near the distal end of the housing 110 to reduce the distance between the bending assembly 150 and the distal end of the needle hub 122 and improve bending efficiency.

The proximal end of the second fixing member 162 may be provided with a mating groove 1621, and the extrusion 164 may be rotatably inserted into the mating groove 1621 such that the extrusion 164 may move axially when the extrusion 164 rotates relative to the fixing member. The seal 165 may be radially disposed between the stationary member 162 and the extrusion 164. The sealing member 165 may be annular and have a certain deformation function, and may be a rubber ring. The proximal end of the pulling member 151 extends from within the wall of the needle hub 122 and through the first securing member 161 to be coupled to the compression member 154. The distal end of the needle cannula 121 may pass through the expression member 164, the sealing member 165, the second securement member 162, the second connector member 163, and the first securement member 161 in that order and into the needle hub 122. In the process that the extrusion member 164 moves toward the bottom of the fitting groove 1621, the extrusion member 164 can be fitted with the second fixing member 162 to extrude the sealing member 165, so that the sealing member 165 can be deformed and increased in the radial direction, the gap between the needle tube 121 and the second fixing member 162 in the radial direction can be eliminated, and the effect of preventing tissue cells, liquid and the like from penetrating into the second connecting member 163 from the proximal end of the needle sleeve 122 and then penetrating into the housing 110 from the gap between the needle tube 121 and the second fixing member 162 can be achieved.

In this embodiment, as shown in fig. 4 and 7, a threaded structure 166 may be provided between the second fixing member 162 and the pressing member 164. The second securing member 162 and the extrusion 164 may be fixedly coupled by a threaded structure 166. The thread structure 166 includes internal threads 1662 and external threads 1661 that mate with the internal threads 1662. The internal threads 1662 may be disposed within the mating groove 1621 and on an inner wall of the second securing member 162, and the external threads 1661 may be disposed on a peripheral wall of the extrusion 164. Alternatively, the internal threads 1662 may be provided on the peripheral wall of the extrusion 164 and the external threads 1661 may be located within the mating groove 1621 and on the inner wall of the second fixture 162.

It will be appreciated that in other embodiments, the first rotating member 131 may be omitted, and the pushing action of the needle cannula 121 may be achieved as long as the pushing member 132 protrudes from the housing 110 and moves along a longitudinal center axis parallel to the housing 110. It will also be appreciated that in other embodiments, the second rotating member 152 may be omitted, so long as the pulling member 153 may protrude from the housing 110 and move parallel to the longitudinal center axis of the housing 110, and may also function as the bending needle sleeve 122.

As shown in fig. 9 to 12, the biopsy device 100 provided in this embodiment is substantially the same as the first embodiment. Specifically, the needle cannula 121 of the aspiration assembly 120 is axially movable and extends through the housing 110. The needle hub 122 is disposed through the distal end of the housing 110, and the distal end of the needle hub 122 protrudes beyond the distal end of the housing 110. At least part of the needle tube 121 is accommodated in the needle sleeve 122, and the needle tube 121 is movably penetrated in the needle sleeve 122 along the axial direction. The needle core 123 axially penetrates the needle tube 121 and fills the inner cavity of the needle tube 121. A sensing element 141 is located within the housing 110 and is disposed between the proximal end of the needle cannula 121 and the pusher 132. The display unit 142 is disposed outside the housing 110 and electrically connected to the sensing element 141. The pushing member 132 of the pushing assembly 130 is located in the first rotating member 131, and the pushing member 132 is rotatably connected to the first rotating member 131, and the needle tube 121 is connected to the pushing member 132. The distal end of the pulling member 151 of the buckle assembly 150 may be disposed through the wall of the needle sheath 122 and secured to the distal end of the needle sheath 122. The proximal end of the pulling member 151 may extend out of the needle hub 122 from within the wall of the needle hub 122 and be positioned within the housing 110.

This embodiment differs from the first embodiment in that in this embodiment the propulsion assembly 130 is disposed near the distal end of the housing 110 and the bending assembly 150 is disposed near the proximal end of the housing 110. The pushing assembly 130 is close to the distal end of the housing 110, so that an operator can quickly and timely detect the state of the display unit 142 and timely perform corresponding actions. In this embodiment, as shown in fig. 10 to 12, the pulling member 153 may be sleeved on the first connecting member 134 and located between the proximal end of the housing 110 and the pushing member 132. The pulling member 153 is axially movable on the first link 134. The proximal end of the pulling member 151 extends from the wall of the needle sheath 122, sequentially passes through the through hole 1611 of the first fixing member 161, the through hole 1323 of the pushing member 132, and the distal end of the through hole 1535 of the pulling member 153, enters the through hole 1541 of the pressing member 154, passes through the proximal end surface of the through hole 1535 of the pulling member 153, and then is connected to the pressing member 154. The axial directions of the through holes are all parallel to the longitudinal central axis of the biopsy device 100 and are located on the same side of the longitudinal central axis of the biopsy device 100, in addition, the distance between the longitudinal central axes of the through

holes

1611, 1323 and 1535 of the first fixing member 161, the pushing member 132 and the pulling member 153 and the longitudinal central axis of the biopsy device 100 is gradually increased, so as to prevent the abrupt change of the bonding stress between the pulling member 151 and the first fixing member 161, the pushing member 132 and the pulling member 153, thereby reducing the risk of fracture between the pulling member 151 and the first fixing member 161, the pushing member 132 and the pulling member 153 and prolonging the service life of the pulling member 151.

As shown in fig. 13, the biopsy device 100 provided in this embodiment is substantially the same as the first embodiment. In contrast, in the present embodiment, the display unit 142 may be disposed at the proximal end of the first connecting member 134. Since the proximal end of the biopsy device 100, i.e., the proximal end of the first connector 134 is facing the operator when the operator operates the biopsy device 100, the display unit 142 is disposed at the proximal end of the first connector 134, so that the operator can observe the display condition of the display unit 142 conveniently, and the biopsy device 100 is controlled to insert the needle according to the display condition of the display unit 142, thereby improving the biopsy efficiency.

In other embodiments, the display unit 142 may include indicators that can display different colors. It will be appreciated that when sensing element 141 detects that the resistance experienced by needle cannula 121 exceeds a preset threshold, the indicator light will appear red. When sensing element 141 detects that the resistance of needle cannula 121 is below a predetermined threshold, the indicator light will appear green.

Of course, the indicator light can also display colors other than red when the sensing element 141 detects that the resistance of the needle cannula 121 exceeds a preset threshold. When sensing element 141 detects that the resistance of needle cannula 121 is below a preset threshold, the indicator light can display a color other than green. As long as sensing element 141 detects that the resistance force experienced by needle cannula 121 is below a preset threshold, the color displayed by the indicator light may be different from the color displayed by sensing element 141 when the resistance force experienced by needle cannula 121 exceeds the preset threshold. I.e. the indicator lights indicate to the operator the penetration of the bronchial wall by the needle cannula 121.

The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, or alternatives falling within the spirit and principles of the invention.

Claims

1. A biopsy device, characterized in that: the device comprises a shell, a suction assembly, a pushing assembly and a sensing assembly, wherein the suction assembly comprises a needle tube capable of moving along the axial direction, the needle tube penetrates through the shell, the far end of the needle tube can extend out of the far end of the shell, the sensing assembly is connected with the pushing assembly and the needle tube, the sensing assembly can detect and feed back whether the resistance of the needle tube exceeds a threshold value or not in the process that the pushing assembly drives the needle tube to push to target tissues.

2. The biopsy device of claim 1, wherein: the pushing assembly comprises a pushing piece connected with the needle tube and a first rotating piece connected with the pushing piece in a rotating mode, and the first rotating piece and the pushing piece rotate relatively to enable the pushing piece to drive the needle tube to push to target tissues.

3. The biopsy device of claim 2, wherein: the sensing component comprises a sensing piece, wherein the sensing piece is positioned in the shell and arranged between the proximal end of the needle tube and the pushing piece, so that whether the resistance of the needle tube exceeds a threshold value is detected in the process that the pushing piece drives the needle tube to advance towards target tissues.

4. A biopsy device according to claim 3, wherein: the sensing piece comprises a fixed part fixedly connected with the pushing piece and an elastic part arranged at the far end of the fixed part, the near end of the needle tube is fixedly connected with the elastic part, and the needle tube penetrates into target tissues to be subjected to resistance so as to drive the elastic part to axially displace relative to the fixed part, so that whether the resistance of the needle tube exceeds a threshold value is detected.

5. The biopsy device of claim 4, wherein: the distal end of the pushing piece is provided with a positioning groove, the fixing part is accommodated in the positioning groove, and the proximal end of the fixing part is fixedly connected with the bottom of the positioning groove.

6. A biopsy device according to claim 3, wherein: the sensing assembly further comprises a display unit, wherein the display unit is arranged outside the shell and is electrically connected with the sensing piece, so that whether the resistance of the needle tube detected by the sensing piece exceeds a threshold value or not can be reflected.

7. The biopsy device of claim 1, wherein: the aspiration component further comprises a needle sleeve penetrating through the far end of the shell, the far end of the needle sleeve protrudes out of the far end of the shell, the needle tube is movably penetrated through the needle sleeve along the axial direction, and the biopsy device further comprises a bending component used for bending the far end of the needle sleeve.

8. The biopsy device of claim 7, wherein: the bending adjustment assembly comprises a traction piece, wherein the distal end of the traction piece is fixed with the distal end of the needle sleeve, so that the distal end of the needle sleeve can be driven to bend when the traction piece is pulled.

9. The biopsy device of claim 8, wherein: the bending adjusting assembly further comprises a second rotating piece and a pulling piece, wherein the pulling piece is located in the shell and connected with the proximal end of the pulling piece, and the second rotating piece is sleeved on the shell and is rotationally connected with the pulling piece, so that the pulling piece can move along the axial direction to drive the pulling piece to pull the distal end of the needle sleeve to bend.

10. The biopsy device of claim 9, wherein: the bending adjusting assembly further comprises a pressing piece inserted into the traction piece, and after the proximal end of the traction piece passes through the pressing piece, the pressing piece can rotate relative to the traction piece, so that the proximal end of the traction piece is pressed against the traction piece.

11. The biopsy device of claim 10, wherein: the proximal end of the traction member passes through the compression member for a length greater than or equal to one-half the circumference of the compression member.

12. The biopsy device of claim 7, wherein: and a sealing structure is arranged between the pushing assembly and the bending adjusting assembly.