WO2021207876A1

WO2021207876A1 - Disposable cytological biopsy needle

Info

Publication number: WO2021207876A1
Application number: PCT/CN2020/084464
Authority: WO
Inventors: 苏州市立普医疗科技有限公司; 王沁
Original assignee: 苏州市立普医疗科技有限公司
Priority date: 2020-04-13
Filing date: 2020-04-13
Publication date: 2021-10-21

Abstract

Disclosed is a disposable cytological biopsy needle, relating to the technical field of medical supplies. The biopsy needle comprises an inner needle assembly and an outer needle assembly, wherein the outer needle assembly comprises an outer needle holder (3), and the inner needle assembly comprises an inner needle holder (7); the middle of the outer wall of the outer needle holder (3) is provided with a protruding hand position; and the biopsy needle further comprises an automatic ejecting assembly, the automatic ejecting assembly comprising an elastic member and a toggle button (41) for triggering ejection of the elastic member, with one end of the elastic member abutting against the hand position, and the other end thereof abutting against the inner needle holder (7), and the toggle button (41) being connected to the outer needle holder (3). When the elastic member is ejected, the inner needle holder (7) is pushed to move away from the hand position to move an inner needle core (2) into an outer needle tube (1), such that the outer needle tube (1) forms a sampling space (10) between the end of the outer needle tube (1) and the end of the inner needle core (2). The disposable cytological biopsy needle is provided with the automatic ejecting assembly, such that during a surgical operation, a surgeon can adjust and trigger the operation of the biopsy needle with one hand, thereby reducing the personnel allocation in the surgical operation and improving the working efficiency of the surgeon.

Description

A disposable cytology biopsy needle

Technical field

The present invention relates to the technical field of medical supplies, in particular to a disposable cytology biopsy needle for thyroid, liver, pancreatic lymphatic and other biopsy operations.

Background technique

Thyroid nodule is a common thyroid disease. When detecting, it is necessary to perform a biopsy of the thyroid nodule and take out the corresponding thyroid cells for laboratory tests to further determine whether the nodule is benign or malignant. Thyroid puncture needle aspiration biopsy is a highly accurate diagnostic method and has been widely used in the diagnosis of nodular thyroid diseases.

The thyroid puncture needle includes an inner needle core and an outer needle tube. During the biopsy, the needle tip of the puncture needle is pierced into the nodule with the assistance of ultrasound equipment. At this time, the doctor holds the outer needle holder with one hand to keep the position unchanged, and operates with the other hand With the ultrasound probe, the doctor’s assistant pulls out the inner needle core for a short period or directly, and then the doctor pinches the outer needle seat to perform reciprocating puncture at the nodule (usually more than 5 reciprocations), so that the cells at the nodule enter the outer needle After the puncture is completed, the puncture needle is pulled out, and the cells are taken out for laboratory analysis; the cycle above the surgical process, multiple puncture operations for thyroid nodules are performed.

The existing puncture operation requires at least the cooperation of a doctor and an assistant to complete, not only the operation method, but also a certain waste of medical resources.

Summary of the invention

In view of this, the present invention provides a disposable cytology biopsy needle with an automatic ejection component. During the operation, the doctor can use one hand to adjust and trigger the biopsy needle, which can reduce the staffing during the operation. Improve the efficiency of doctors.

One aspect of the present invention provides a disposable cytological biopsy needle, comprising an inner needle assembly and an outer needle assembly, the outer needle assembly includes an outer needle seat, the inner needle assembly includes an inner needle seat, and the middle of the outer wall of the outer needle seat is provided with a protrusion The puncture needle further includes an automatic ejection assembly; the automatic ejection assembly includes an elastic member and a toggle button for triggering the ejection of the elastic member, one end of the elastic member abuts against the hand position, and the other end abuts against the inner needle seat The knob is connected with the outer needle seat; when the elastic member is ejected, the inner needle seat is pushed to move away from the hand position, so that the inner needle core moves into the outer needle tube, so that the outer needle is located between the end of the outer needle tube and the end of the inner needle core. The needle tube forms a sampling space.

Optionally, the elastic member is a spring, and the spring is sleeved on the outer needle seat; the end of the inner needle seat facing the spring is provided with two parallel extension rods extending outward along the axis of the inner needle seat; one end of the spring is connected to the hand The other end is connected with a supporting piece, the supporting piece is sleeved on the outer needle seat in a ring shape, and the supporting piece abuts against the free end of the extension rod.

Optionally, the support sheet includes a front support sheet and a rear support sheet, and the front support sheet and the rear support sheet are butted to form an annular structure.

Optionally, the automatic eject assembly further includes a blocking member; the blocking member is provided at the end of the outer wall of the outer needle seat, the spring and the supporting piece can move between the hand position and the blocking member, and there are two blocking members. A gap, the free end of the extension rod passes through the two gaps and abuts against the support piece; the free end of the extension rod is provided with a hook, and the spring pops out to make the hook abut against the inner wall of the blocking member to avoid inner needles The seat is separated from the support piece.

Optionally, in the stroke between the hand position and the stopper, the spring is always in a compressed state.

Optionally, the blocking member is a locking thread protruding from the outer wall of the outer needle seat.

Optionally, the automatic eject assembly further includes a cylindrical cover plate, which is sleeved on the outer needle seat between the hand position and the blocking member, and a gap is provided between the cover plate and the outer wall of the outer needle seat. , The spring and the supporting piece are arranged in the interval; the toggle button is arranged on the cover plate, the cover plate has a through hole, the toggle button has an elastic arm, one end of the elastic arm is connected with the side wall of the through hole, and the other end is provided with a toggle The toggle part is located on the outer side of the cover plate, and the raised structure is located on the inner side of the cover plate; the support sheet is provided with a buckle, and the buckle is clamped with the raised structure to keep the spring in a compressed state.

Optionally, the cover plate includes a left cover plate and a right cover plate, the toggle button is arranged on the left cover plate or the right cover plate, and the left cover plate and the right cover plate are connected to form a cylindrical shape; The end facing the hand position is provided with a plug, and the hand position is provided with a jack corresponding to the plug, and the plug is inserted into the jack so that the ends of the left cover plate and the right cover plate abut against the hand position.

Optionally, a gap is provided between the abutting surfaces of the left cover plate and the right cover plate, so that the cover plate has two guide channels parallel to the spring axis; Two protruding sliders are provided and they are respectively located in the guide channel, and the extension rod is located in the guide channel and abuts against the protruding slider.

Optionally, the end of the outer needle seat away from the outer needle tube is a luer connector.

The disposable cytology biopsy needle provided by the present invention has an automatic ejection component. During an operation, the doctor can complete the adjustment and trigger operation of the biopsy needle with one hand, which can reduce the staffing in the operation and improve the work efficiency of the doctor.

Description of the drawings

For purposes of illustration and not limitation, the present invention will now be described according to preferred embodiments of the present invention, particularly with reference to the accompanying drawings, in which:

Figure 1 is a schematic structural diagram of a disposable cytological biopsy needle provided by an embodiment of the present invention;

Figure 2 is an exploded view of a disposable cytological biopsy needle provided by an embodiment of the present invention;

Figure 3 is a schematic diagram of the structure of the outer needle assembly;

Figure 4 is a schematic diagram of the structure of the inner needle assembly;

Figure 5 is a schematic diagram of the structure of the outer needle tube and the end of the inner needle core;

Figure 6 is a schematic diagram of the structure of the outer needle seat;

Figure 7 is a schematic diagram of the structure of the left cover;

Fig. 8 is a schematic diagram of the structure of the inner needle holder.

In the picture:

1: Outer needle tube; 2: Inner needle core; 3: Outer needle holder; 4: Left cover; 5: Rear support piece; 6: Spring; 7: Inner needle holder; 8: Front support piece; 9: Right cover ; 10: sampling space; 31: left pressing position; 32: right pressing position; 33: locking thread; 34: Luer connector; 41: dial button; 71: front hook; 72: rear hook; 73: extension Rod; 411: raised structure; 412: toggle part.

Detailed ways

In the embodiment of the present invention, an automatic ejection component is added to the outer needle holder. After the toggle button is triggered, the inner needle holder can be automatically ejected under the action of the elastic member. The doctor can complete the operation by one person without the cooperation of others, thereby reducing operations The staffing in, improve the work efficiency of doctors, which will be explained in detail below.

Fig. 1 is a schematic structural diagram of a disposable cytological biopsy needle provided by an embodiment of the present invention; Fig. 2 is an exploded view of a disposable cytological biopsy needle provided by an embodiment of the present invention; Fig. 3 is a structure of an outer needle assembly Schematic diagram; Figure 4 is a schematic structural diagram of the inner needle assembly. As shown in Figures 1 to 4, the biopsy needle is used for puncture sampling operations, such as thyroid puncture operations. The biopsy needle includes an inner needle assembly and an outer needle assembly. The inner needle assembly is composed of an inner needle seat 7 and an inner needle core 2. The needle assembly is composed of an outer needle seat 3, an outer needle tube 1 and an automatic ejection assembly. The automatic ejection assembly includes a left cover plate 4, a right cover plate 9, a front support sheet 8, a rear support sheet 5 and a spring 6.

As shown in Figure 2, in the embodiment of the present invention, the elastic member is a spring 6, and the spring 6 is sleeved on the outer needle seat 3; An extension rod 73 extending outward in the axial direction; one end of the spring 6 is in contact with the hand position, and the other end is connected to a supporting piece. It is provided on the outer needle hub 3, and the support piece abuts against the free end of the extension rod 73. The elastic member adopts the structure of the spring 6 and can be sleeved on the outer needle seat 3, and the spring 6 has the advantages of long service life and stable resilience. The supporting piece adopts a split structure to facilitate assembly operations.

6 is a schematic diagram of the structure of the outer needle holder; FIG. 8 is a schematic diagram of the structure of the inner needle holder; as shown in FIGS. 6 and 8, the automatic ejection assembly further includes a blocking member; the blocking member is provided on the outer wall of the outer needle holder 3 At the end of the, the spring 6 and the supporting piece can move between the hand position and the blocking piece. There are two notches on the blocking piece. The free ends of the extension rod 73 respectively pass through the two notches and then abut the supporting piece; The free end of the rod 73 is provided with a hook, and the spring 6 pops out to make the hook abut against the inner wall of the blocking member to prevent the inner needle seat 7 from being separated from the supporting piece. Wherein, preferably, the blocking member is a locking thread 33 protruding from the outer wall of the outer needle seat 3, and the locking thread 33 is convenient for locking connection with other medical devices. The needle seat 3 is locked and connected. The stopper acts as a limit to the spring 6. When the spring 6 rebounds, the hook on the extension rod 73 is locked on the locking thread 33 and cannot move further, so as to prevent the inner needle seat 7 from leaving the stroke range. Wherein, in the stroke between the hand position and the blocking member, the spring 6 is always in a compressed state, and the spring 6 in the compressed state can maintain the elastic force applied to the inner needle seat 7 to ensure that the purpose of driving the inner needle seat 7 is achieved.

Fig. 7 is a schematic structural diagram of the left cover plate 4; as shown in Fig. 7, the automatic eject assembly further includes a cylindrical cover plate, which is sleeved on the outer needle seat 3 between the hand position and the blocking member , A gap is provided between the cover plate and the outer wall of the outer needle seat 3, and the spring 6 and the supporting piece are arranged in the gap; the dial button 41 is provided on the cover plate, the cover plate has a through hole, and the dial button 41 has an elastic arm, One end of the elastic arm is connected with the side wall of the through hole, and the other end is provided with a toggle portion 412 and a protrusion structure 411. The toggle portion 412 is located on the outside of the cover plate, and the protrusion structure 411 is located on the inside of the cover plate; The buckle is buckled with the protruding structure 411 to keep the spring 6 in a compressed state. The cover plate includes a left cover plate 4 and a right cover plate 9. The toggle button 41 is arranged on the left cover plate 4 or the right cover plate 9. The left cover plate 4 and the right cover plate 9 are butt-connected to form a cylindrical shape; the left cover plate 4 and The end of the right cover plate 9 facing the hand position is provided with a plug, and the hand position is provided with a socket corresponding to the plug. Abut. The cover adopts a split structure to facilitate assembly operations.

As shown in Figures 1 and 3, a gap is provided between the abutting surfaces of the left cover plate 4 and the right cover plate 9, so that the cover plate has two guide channels parallel to the axial direction of the spring 6; The two gaps of the support sheet are provided with two protruding sliders which are respectively located in the guide channel, and the extension rod 73 is located in the guide channel and abuts against the protruding slider. The extension rod 73 slides in the guide channel. By setting the guide channel, the extension rod 73 and the outer needle seat 3 can be quickly connected. At the same time, the protruding sliding block on the support sheet is arranged in the guide channel to prevent the support sheet and the spring 6 from rotating. Reduce the chance of turning on the dial button 41 by mistake.

In the biopsy needle provided by the embodiment of the present invention, when in use, with the assistance of imaging equipment, the assembled inner needle assembly and outer needle assembly are punctured to a designated position. At this time, under the action of the automatic ejection assembly, the inner needle seat 7 Pops out a certain stroke, and then drives the inner needle core 2 to move outward synchronously. Figure 5 is a schematic diagram of the structure of the outer needle tube and the end of the inner needle core. As shown in Figure 5, when the inner needle core 2 moves a certain stroke, the biopsy The needle tip part of the needle forms the sampling space 10. The doctor holds the biopsy needle for reciprocating puncture (usually more than 5 reciprocations), and some cells in the nodule remain in the sampling space 10, pull out the biopsy needle, and take out the nodule in the sampling space 10. Ganglion cells for medical analysis.

The following is the specific operation method of the biopsy needle provided by the embodiment of the present invention: Firstly, the outer needle assembly and the inner needle assembly are assembled and combined, that is, the inner needle core 2 is inserted into the outer needle tube 1 through the luer connector 34 of the outer needle seat 3 , The extension rod 73 on the inner needle seat 7 has a certain deformability, the extension rod 73 is pulled outwards, and then the hook of the extension rod 73 is first set (one extension rod 73 is provided with a front hook 71, and the other extends The rod 73 is provided with a rear hook 72) extending from the guide channel into the space between the cover plate and the outer needle seat 3, and then the extension rod 73 is left in the guide channel. Pushing the inner needle holder 7 to move toward the outer needle holder 3, the free end of the extension rod 73 abuts on the supporting piece, and the thrust is transmitted from the supporting piece to the spring 6. The spring 6 is compressed under the pushing force, and at the same time, the supporting piece synchronizes with the spring 6. Move to the 3 direction of the outer needle seat. When the support plate moves to the position of the dial button 41, the buckle on the support plate is clamped on the protrusion structure 411 of the dial button 41, and a "click" sound is emitted when the clamp is connected. At this time, the completion is completed. The assembly between the inner needle assembly and the outer needle assembly.

After the inner needle assembly and the outer needle assembly are assembled, the puncture operation can be performed. During the operation, the doctor operates the ultrasound probe with one hand, and the thumb and middle finger of the other hand hold the left pressing position 31 and right of the outer needle holder 3 respectively. Press the position 32 and place the index finger on the dial 412 of the dial button 41. After the puncture position is determined under the guidance of the ultrasound probe, the thumb and middle finger hold the outer needle holder 3, and pierce the biopsy needle into the patient’s thyroid along the needle tip. Nodules, so that the tip of the needle is inside the nodules. At this time, the index finger triggers the toggle portion 412 to separate the protruding structure 411 of the toggle button 41 from the buckle of the support piece. The compressed spring 6 rebounds to push the support piece to move, and the resilient force acts on the extension rod 73 to drive the inner The needle holder 7 moves in the reverse direction, and finally, the hook on the extension rod 73 is clamped on the locking thread 33, and the inner needle holder 7 stops moving. At this time, since the spring 6 is still in the rebound state, the support plate continues to be applied back. Elastic force, so that the inner needle seat 7 remains in this position. The inner needle seat 7 drives the inner needle core 2 to move in the opposite direction for a certain distance, so that a vacuum sampling space 10 is formed between the inner needle core 2 and the outer needle tube 1.

The doctor holds the outer needle holder 3 and sucks back and forth along the needle tip direction for at least 5 cycles. The cells from the thyroid nodules enter the sampling space 10 due to the reciprocating motion and negative pressure. At this time, the sampling operation is completed, the biopsy needle is pulled out of the thyroid gland, the extension rod 73 is pulled to separate the inner needle seat 7 from the outer needle seat 3, and then a syringe is used to connect the Luer connector 34 to remove the cells in the sampling space 10 for storage. Into the designated inspection container for testing. So far, one puncture is completed, and when a second or more puncture operations are required, repeat the above-mentioned puncture operation process.

The foregoing specific implementations do not constitute a limitation on the protection scope of the present invention. Those skilled in the art should understand that, depending on design requirements and other factors, various modifications, mixing, sub-mixing, and substitutions can occur. Any modification, equivalent replacement and improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

A disposable cytological biopsy needle, comprising an inner needle assembly and an outer needle assembly, the outer needle assembly includes an outer needle seat (3), the inner needle assembly includes an inner needle seat (7), and the outer needle seat (3) is provided in the middle of the outer wall Has a protruding hand position, which is characterized by:

The puncture needle also includes an automatic ejection component;

The automatic ejection assembly includes an elastic piece and a toggle button (41) for triggering the ejection of the elastic piece. One end of the elastic piece abuts against the hand position, the other end abuts against the inner needle seat (7), and the toggle button (41) and the outer needle Block (3) connection;

When the elastic member is ejected, the inner needle holder (7) is pushed to move away from the hand position, so that the inner needle core (2) moves into the outer needle tube (1), so that the end of the outer needle tube (1) and the inner needle core (2) ) The outer needle tube (1) between the ends forms a sampling space.
The disposable cytological biopsy needle according to claim 1, wherein:

The elastic piece is a spring (6), and the spring (6) is sleeved on the outer needle seat (3);

The inner needle seat (7) is provided with two parallel extension rods (73) extending outward along the axis of the inner needle seat (7) at one end facing the spring (6);

One end of the spring (6) is in contact with the hand position, and the other end is connected with a support piece, the support piece is annularly sleeved on the outer needle seat (3), and the support piece abuts against the free end of the extension rod (73).
The disposable cytological biopsy needle according to claim 2, characterized in that the support sheet comprises a front support sheet (8) and a rear support sheet (5), and the front support sheet (8) and the rear support sheet (5) are formed by butting Ring structure.
The disposable cytological biopsy needle according to claim 2, wherein the automatic ejection component further comprises a blocking member;

The sealing piece is arranged at the end of the outer wall of the outer needle seat (3). The spring (6) and the supporting piece can move between the hand position and the sealing piece. There are two notches on the sealing piece, and the extension rod (73) is free. After passing through the two notches respectively, the ends abut against the supporting piece;

The free end of the extension rod (73) is provided with a hook, and the spring (6) pops out to make the hook abut against the inner wall of the blocking member, so as to prevent the inner needle seat (7) from being separated from the supporting piece.
The disposable cytology biopsy needle according to claim 4, characterized in that the spring (6) is always in a compressed state during the stroke between the hand position and the stopper.
The disposable cytological biopsy needle according to claim 4, wherein the blocking member is a locking thread (33) protruding from the outer wall of the outer needle seat (3).
The disposable cytological biopsy needle according to claim 4, wherein the automatic ejection assembly further comprises a cylindrical cover plate, which is sleeved on the outer needle seat between the hand position and the stopper ( 3) On the upper part, there is a gap between the cover plate and the outer wall of the outer needle seat (3), and the spring (6) and the supporting piece are arranged in the gap;

The dial button (41) is arranged on the cover plate. The cover plate has a through hole. The dial button (41) has an elastic arm. The raised structure (411), the toggle portion (412) is located on the outer side of the cover plate, and the raised structure (411) is located on the inner side of the cover plate;

A buckle is arranged on the supporting piece, and the buckle is buckled with the protruding structure (411) to keep the spring (6) in a compressed state.
The disposable cytology biopsy needle according to claim 7, wherein the cover plate comprises a left cover plate (4) and a right cover plate (9), and the dial button (41) is arranged on the left cover plate (4) Or on the right cover plate (9), the left cover plate (4) and the right cover plate (9) are butted to form a cylindrical shape;

The end of the left cover (4) and the right cover (9) facing the hand position is provided with a plug, and the hand position is provided with a socket corresponding to the plug. The plug is inserted into the socket so that the left cover (4) and The end of the right cover (9) forms abutment with the hand position.
The disposable cytological biopsy needle according to claim 8, wherein a gap is provided between the abutting surfaces of the left cover plate (4) and the right cover plate (9), so that the cover plate has two shafts parallel to the spring Directional guide channel;

The guide channel penetrates through the two notches on the sealing member, the support sheet is provided with two raised sliding blocks and they are respectively located in the guide channel, and the extension rod (73) is located in the guide channel and abuts against the raised sliding block.
The disposable cytological biopsy needle according to any one of claims 1 to 9, characterized in that the end of the outer needle seat away from the outer needle tube is a luer connector (34).