CN117503209A

CN117503209A - tissue biopsy device

Info

Publication number: CN117503209A
Application number: CN202311635612.3A
Authority: CN
Inventors: 王宜欣; 黄桥; 谢琦宗
Original assignee: Hanxin Medical Technology Shenzhen Co ltd
Current assignee: Hanxin Medical Technology Shenzhen Co ltd
Priority date: 2023-11-30
Filing date: 2023-11-30
Publication date: 2024-02-06

Abstract

The invention relates to a tissue biopsy device, which comprises an outer tube, a spiral needle, a rotary cutter fixed at the distal end of the outer tube, a puncture driving assembly, a cutter driving assembly and a connecting piece. The spiral needle is rotatably accommodated in the rotary cutter. The puncture driving assembly is connected with the spiral needle, and the spiral needle is adapted to rotate spirally under the driving of the puncture driving assembly. The cutter driving assembly is connected with the outer tube, and the outer tube is adapted to drive the cutter to spirally rotate under the driving of the cutter driving assembly. The puncture driving assembly is connected with the cutter driving assembly, and the depth of embedding tissues of the spiral needle and the rotary cutter under the constraint of the connecting piece is the same. The biopsy device is convenient to operate, can quantitatively sample, and accurately controls the feeding amount of the rotary cutter in tissues.

Description

Tissue biopsy device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a tissue biopsy device.

Background

Diagnosis and treatment of disease typically requires sampling examination of focal tissue to aid. Biopsy, i.e., biopsy, is the most common means of obtaining pre-operative pathology, including both needle biopsy and surgical biopsy. Compared with surgical biopsy, the puncture biopsy adopts the sampling needle with small diameter to sample, so that the damage to normal tissues is less, bleeding is less, scars are avoided, the patient only needs local anesthesia, the cost is relatively low, and the puncture biopsy is safer and has less infection chance.

The puncture biopsy is suitable for various organs such as kidney, liver, heart, lung, mammary gland, thyroid gland, prostate gland, pancreas, testis, uterus, ovary, body surface and the like. Taking endocardial myocardial biopsy as an example, endocardial myocardial samples are collected for pathological analysis for various myocardial diseases.

The myocardial biopsy forceps are used for grasping and sampling the endocardial myocardium through a catheter along the femoral vein or the jugular vein and into the right ventricle. The method specifically comprises the following steps: the biopsy forceps are pushed to enable the forceps head to contact the right ventricular surface of the ventricular septum, the control sliding block of the operating handle is pushed outside the body to open the biopsy forceps head and prop against the right ventricular surface of the ventricular septum, the biopsy forceps are closed rapidly, and the tissue is grasped to withdraw from the body.

The grasping and sampling of the myocardial biopsy forceps has the following defects: the operator needs to continuously compress the spring of the control slide block with fingers for a long time in vitro to open and keep the clamp open in the body, so that the operation is inconvenient, if the control slide block is not pushed in place, the clamp cannot be opened to a preset angle, finally, the tissue sample is not sufficiently pathologically analyzed or the tissue cannot be grasped at all, secondary operation is needed, and the operation time is greatly prolonged; when the biopsy forceps are used for grabbing and stripping tissues, the forceps are only closed rapidly to cut off the tissues, the endocardium has good flexibility, and the biopsy forceps cannot be pinched off by the forceps when the grabbing amount is large, and the biopsy forceps need to be pulled out by an operator forcefully, so that the tissues are easy to tear; the grasping depth cannot be controlled, if the grasping depth is not operated properly, the risk of the forceps penetrating the myocardial wall exists, and the life safety of a patient is seriously endangered.

Disclosure of Invention

The invention provides a tissue biopsy device which is convenient to operate, can quantitatively sample tissues and can precisely control the feeding amount of a rotary cutter.

The tissue biopsy device provided by the technical scheme of the invention comprises an outer tube, a spiral needle, a rotary cutter fixed at the distal end of the outer tube, a puncture driving assembly, a cutter driving assembly and a connecting piece. The spiral needle is rotatably accommodated in the rotary cutter. The puncture driving assembly is connected with the spiral needle, and the spiral needle is adapted to rotate spirally under the driving of the puncture driving assembly. The cutter driving assembly is connected with the outer tube, and the outer tube is adapted to drive the cutter to spirally rotate under the driving of the cutter driving assembly. The penetration drive assembly is coupled to the cutter drive assembly, and the helical needle and the rotary cutter are adapted to be flush with the same depth of tissue under the constraint of the adapter.

The spiral needle of the tissue biopsy device can rotatably enter the tissue, thereby not only playing a role of positioning the biopsy device in the tissue, but also grabbing part of the tissue while rotating. The tissue biopsy device adopts the connecting piece to restrict the spiral needle and the rotary cutter, so that the depth of embedding the spiral needle and the rotary cutter into tissues is the same, and the same sampling amount of the tissues is ensured each time.

The connector constrains the lancing drive assembly and the cutter drive assembly in a variety of ways. As a preferred embodiment, the cutter drive assembly is first coaxially threadedly engaged with the connector in a distal to proximal direction, and the connector is then coaxially threadedly engaged with the puncture drive assembly. That is, the connector is coaxially threadedly engaged with the lancing drive assembly and the cutter drive assembly, respectively, to indirectly connect the lancing drive assembly and the cutter drive assembly, and the helical needle and the cutter drive assembly are adapted to be helically rotatable relative to the connector, respectively.

In the tissue biopsy device according to the embodiment of the present invention, the distal end of the connecting member is provided with a first protrusion, and the proximal end of the cutter driving assembly is provided with a second protrusion, and a predetermined distance is provided between the first protrusion and the second protrusion when the cutter driving assembly is not in operation, i.e. in a natural assembled state of the tissue biopsy device. When the cutter driving assembly rotates along the connecting piece to be mutually abutted with the first protrusion and the second protrusion, the cutter driving assembly can not rotate relative to the connecting piece any more, and the rotary cutter reaches the maximum rotation displacement position. Namely, the distance between the first bulge and the second bulge along the axial direction of the connecting piece in the natural assembly state of the tissue biopsy device is the maximum rotation displacement of the rotary cutter.

Specifically, in the tissue biopsy device provided by an embodiment of the present invention, the connecting member has a through hole penetrating through a proximal end and a distal end thereof, and the cutter driving assembly is sleeved outside the connecting member and is engaged with an outer circumferential surface of the connecting member through threads. The lancing drive assembly is threadably engaged with the connector within the throughbore and is adapted to rotate relative to the connector until a maximum rotational displacement is reached.

In the tissue biopsy device provided by an embodiment of the present invention, the puncture driving assembly comprises a screw, a control slider and a threaded slider, wherein the screw is adapted to rotate around the axis thereof under the drive of the control slider in the process that the control slider slides from a starting point to an ending point; the distal end of the thread slider is connected with the spiral needle, and the proximal end of the thread slider is connected with the screw rod; the threaded slider is in threaded engagement with the connector in the through hole and is adapted to rotate relative to the connector upon rotation of the screw until the screw needle reaches its maximum rotational displacement.

In one embodiment of the present invention, the pitch of the thread of the helical needle is equal to the pitch of the thread of the helical tip. Thereby, the rotation displacement of the thread slider is ensured to be equal to that of the spiral needle, and the feeding amount of the spiral needle into the tissue is accurately controlled.

In the tissue biopsy device provided by the embodiment of the invention, the puncture driving assembly further comprises two mutually parallel sliding rails, the two sliding rails and the screw rod penetrate through two opposite surfaces of the control sliding block, the screw rod is arranged between the two sliding rails and is parallel to the sliding rails, the two sliding rails are provided with a first limit buckle at the starting point and a second limit buckle at the end point, and the control sliding block is detachably limited on the sliding rails through the first limit buckle and the second limit buckle respectively.

In order to facilitate operation, in the tissue biopsy device according to an embodiment of the present invention, the puncture driving assembly further includes a push-pull ring, proximal ends of the two sliding rails converge on the push-pull ring, and a proximal end of the screw is rotatably connected with the push-pull ring. Thus, the operator, after completing the sampling, pulls the push-pull ring to withdraw the distal portion of the biopsy tissue outside the body except for the handle.

For application scenarios requiring remote delivery of a biopsy device along a human blood vessel to a tissue within the human body for biopsy, the biopsy device is required to have better compliance to accommodate bending and tortuosity of the blood vessel. In the tissue biopsy device provided by the embodiment of the invention, the puncture driving assembly further comprises a transmission core wire, and the distal end and the proximal end of the transmission core wire are fixedly connected with the spiral needle and the thread slider respectively.

In the tissue biopsy device according to an aspect of the present invention, the spiral needle and the rotary cutter are screw-engaged with each other. Therefore, the change of the strokes of the spiral needle and the rotary cutter caused by the bending of the outer tube and the transmission core wire in the blood vessel can be effectively avoided, and the cutting precision of the biopsy device is further improved.

In the tissue biopsy device provided by the technical scheme of the invention, the needle point of the spiral needle is flush with the edge of the rotary cutter, and the spiral nail and the rotary cutter have equal maximum rotation displacement. The biopsy device is convenient to manufacture, and the maximum rotation displacement of the spiral needle and the rotary cutter is not required to be designed according to the distance difference between the needle point and the cutting edge in the initial state, so that the needle point is flush with the cutting edge when the spiral nail and the rotary cutter are at the maximum rotation displacement, and the depth of finally embedding the spiral needle and the rotary cutter into tissues is ensured to be the same.

To further facilitate operation, in the biopsy device according to an embodiment of the present invention, the puncture driving assembly further comprises two finger rings located at two opposite sides of the control slider.

In order to simplify the structure of the tissue biopsy and further facilitate the operation, as a preferred embodiment of the present invention, the cutter driving assembly includes a stop portion and a rotating portion having a cavity, the rotating portion is in threaded connection with the distal end of the connecting piece, the proximal end of the outer tube is fixedly connected with the rotating portion, the stop portion is located in the rotating portion and extends proximally from the rotating portion, the first protrusion is located at the distal end of the connecting piece, and the second protrusion is located at the proximal end of the stop portion. The arrangement can rotate the rotating part in place along the connecting piece (namely, the position where the first bulge and the second bulge are mutually abutted) so as to cut tissues, and the cutting device is convenient and quick.

In one embodiment of the present invention, the connector includes a first connector portion and a second connector portion connected to a distal end of the first connector portion. The first connecting part is fixedly connected with the far end of the sliding rail coaxially, the rotating part is meshed with the outer peripheral surface of the second connecting part through threads, and the stop part is positioned in the far end of the second connecting part. In this way, the rotation path of the rotation part is defined by the connecting piece, and the second protrusion on the stopping part is ensured to be accurately aligned with the first protrusion on the second connecting part.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for the description of the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to the structures shown in these drawings without inventive effort for a person skilled in the art.

FIG. 1 schematically illustrates a schematic structural view of a tissue biopsy device provided in a first preferred embodiment of the present invention;

FIG. 2 is a schematic exploded view of the structure of the tissue biopsy device shown in FIG. 1;

FIG. 3a is a schematic view of a slide rail of the tissue biopsy device shown in FIG. 2;

FIG. 3 schematically illustrates a cross-sectional view of the tissue biopsy device shown in FIG. 1 in an initial state;

FIG. 4 is a schematic view of the structure of a spiral needle, a driving core wire, a rotary cutter and an outer tube of a tissue biopsy device according to an embodiment of the present invention;

FIG. 5 is a cross-sectional view of the control, handle body and screw assembly of the biopsy device shown in FIG. 1;

FIG. 6 is a partial cross-sectional view of the control member of the biopsy device shown in FIG. 1 as the helical needle moves to its maximum rotational position as it slides to the end point;

FIG. 7 is an enlarged partial cross-sectional view of the outer tube, drive core wire, cutter drive assembly, connector, threaded slider, handle body and screw of the biopsy device shown in FIG. 6 as the control member slides to an end point;

FIG. 8 is a cross-sectional view of the cutter drive assembly and the linkage, slide and screw of the biopsy device of FIG. 6;

FIG. 9 is a partial cross-sectional view of the tissue biopsy device of FIG. 1 with the cutter drive assembly rotated to an end point, i.e., with the rotary cutter moved to a maximum rotational displacement;

FIG. 10 is a schematic view of the structure of the outer tube, the rotary cutter, the spiral needle and the core wire of the tissue biopsy device according to the second preferred embodiment of the present invention;

fig. 11 is a cross-sectional view of the outer tube, the rotary cutter, the spiral needle and the core wire shown in fig. 10 in an assembled state.

Reference numerals illustrate:

tissue biopsy device: 100; spiral needle: 25, a step of selecting a specific type of material; a rotary cutter: 10; an outer tube: 20, a step of; a handle: 30; spiral tip: 251; needle point: 2511; needle body: 252. Edge of the blade: 101; puncture driving assembly: 31; cutter drive assembly: 95; and (3) a connecting piece: 90; transmission core wire: 40, a step of performing a; a handle body: 70. and (3) a screw rod: 80; and (3) a control part: 60; screw thread slider: 50; slide rail: 71; push-pull ring: 73; the accommodating cavity comprises: 74; assembling head: 711; limit groove: 7111; first limit button: 713; the second limit buckle: 714; control slide block: 62; finger ring: 61; limiting surface: 712. A main body: 52; and (3) connecting heads: 51; a first connection part: 92; a second connection part: 91; and (3) through holes: 915; buckle: 921; a first protrusion: 911; a second protrusion: 912, a step of adding a catalyst to the mixture; a rotating part: 951; stop part: 952.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

It should be noted that all the directional indicators in the embodiments of the present invention are only used to explain the relative positional relationship, movement conditions, etc. between the components in a specific posture, and if the specific posture is changed, the directional indicators are correspondingly changed.

In the present invention, unless specifically stated and limited otherwise, and as is apparent to those of ordinary skill in the art, the terms "connected," "secured," and the like should be construed broadly, and may be, for example, "secured" as well as removably connected, or integrated; can be mechanically or electrically connected; either directly or indirectly through intermediaries, or in communication with each other or in interaction with each other, unless explicitly defined otherwise, the meaning of the terms described above in this application will be understood by those of ordinary skill in the art in view of the specific circumstances.

In addition, the technical solutions of the embodiments of the present invention may be combined with each other, but it is necessary to be based on the fact that those skilled in the art can implement the technical solutions, and when the technical solutions are contradictory or cannot be implemented, the combination of the technical solutions should be considered as not existing, and not falling within the scope of protection claimed by the present invention.

It should be noted that "distal end" and "proximal end" are used as terms of orientation, which are terms commonly used in the field of medical devices, where "distal end" refers to an end far from an operator during a surgical procedure, and "proximal end" refers to an end near to an operator during a surgical procedure. Axial, refers to a direction parallel to the line connecting the distal center and the proximal center of the medical instrument; radial refers to a direction perpendicular to the axial direction.

"feed" refers to the depth of the helical needle or rotary cutter into the sampled tissue. "rotational displacement" refers to the distance of a point from the starting point in the axial direction of the instrument as the instrument, such as a helical needle or rotary cutter, is advanced distally or proximally from the starting point in a helical rotation. When the spiral needle or the rotary cutter rotates from the starting point to the end point, the distance between the starting point and the end point in the axial direction of the tissue biopsy device corresponds to the maximum rotational displacement, and the end point is the maximum rotational displacement.

The working principle of the tissue biopsy device provided by the invention is that the maximum rotation displacement of the spiral needle and the rotary cutter is preset through two driving components respectively, so that the needle point of the spiral needle and the cutting edge of the rotary cutter are flush when the spiral needle and the rotary cutter are positioned at the respective maximum rotation displacement; the two driving components are adopted to sequentially drive the spiral needle and the rotary cutter to rotate to the maximum rotation displacement position of the spiral needle and the rotary cutter, so that the depth of the spiral needle screwed into the tissue is ensured to be equal to the depth of the rotary cutter screwed into the tissue, and quantitative sampling is ensured.

The tissue biopsy device provided by the invention is suitable for sampling soft tissues of a human body. The following detailed description of the biopsy device is given by taking the sample of myocardium in a human body by remotely delivering the distal part of the biopsy device, and is not to be construed as limiting the scope of application of the present invention.

The first preferred embodiment of the present invention provides a tissue biopsy device 100 adapted for remote delivery into a human body through a human body vessel for biopsy sampling, comprising a spiral needle 25 as described in fig. 4, a rotary cutter 10 as shown in fig. 1, an outer tube 20 and a handle 30.

A spiral needle 25 is rotatably received in the rotary cutter 10 for insertion into the sampled soft tissue to locate the biopsy device. The spiral needle 25 may be rotated distally to extend beyond the rotary cutter 10 by an external force.

Referring to fig. 4, the present embodiment provides a helical needle 25 comprising a distal helical tip 251 and a needle body 252 fixedly attached to the proximal end of the helical tip 251. The helical spike 251 has a needle tip 2511. The spiral tip 251 is formed by spirally winding a metal wire, and comprises a plurality of threads, and two adjacent threads are connected end to end and form a thread pitch. The needle 252 includes a hollow tube that serves to secure the helical spike 251 and the drive core wire 40. The helical tip 251 is configured to facilitate easier threading of the helical needle 25 into tissue to be sampled and to accommodate the threaded tissue during threading of the helical needle 25.

In another preferred embodiment of the present invention, the distal portion of the helical needle 25 is housed within the rotary cutter 10, while the remainder on the proximal side may be rotatably located within the lumen of the outer tube 20. In yet another preferred embodiment of the present invention, the helical needle 25 may include only the helical tip 251 and not the needle body 252, in which case the helical tip 252 is fixedly attached directly to the distal end of the drive core wire 40.

With continued reference to fig. 4, the rotary cutter 10 is for helically rotating cutting sampled soft tissue and is generally hollow and tubular with a distal end configured as a blade having a blade edge 101. The proximal end of the rotary cutter 10 is fixed to the distal end of the outer tube 20. The rotary cutter 10 is a metal machining part, and the cutting edge of the rotary cutter is thinner and sharper than a cutter made of high polymer materials, so that the rotary cutter is convenient for rapidly cutting tissues, and is less in abrasion and does not generate fine scraps in a human body even after being used for many times. In an initial state of the biopsy device 100, i.e. a natural state of non-operation, the needle tip 2511 of the spiral needle 25 is flush with the cutting edge 101 of the rotary cutter 10, in a variant of the tissue biopsy device 100 provided in this embodiment, the needle tip 2511 may not be flush with the cutting edge 101.

Referring to fig. 1, the proximal end of the outer tube 20 is connected to the handle 30, and the outer tube 20 is spirally rotated along its own axis and advanced distally by an external force. The outer tube 20 may be a steel tube or spring tube cut into a snake bone tube to provide superior flexibility and suitable mechanical strength, and the outer tube 20 may conform to the curvature of the blood vessel and reduce trauma to the blood vessel when the distal structure of the biopsy device is remotely delivered along the blood vessel of the human body to a biopsy sample of tissue in the body.

Referring to fig. 2, handle 30 includes a lancing drive assembly 31, a cutter drive assembly 95, and a connector 90. The lancing drive assembly 31 includes a drive core wire 40, a handle body 70, a screw 80, a control member 60, and a threaded slider 50.

The puncture driving assembly 31 is for driving the spiral needle 25 to spirally rotate toward the distal end and controlling the maximum rotational displacement of the spiral needle 25. This maximum rotational displacement corresponds to the amount of advancement of the helical tip 251 into the tissue. The cutter drive assembly 95 is configured to drive the rotary cutter 10 to rotate helically distally by driving the outer tube 20 to rotate helically distally, thereby enabling the tissue to be cut for sampling. The connector 90 is connected to the lancing drive assembly 31 and the cutter drive assembly 95, respectively, and the helical needle 25 and the rotary cutter 10 can reach their respective maximum rotational displacement under the constraint of the connector 90. It will be appreciated that the maximum rotational displacement of the rotary cutter 10 corresponds to the depth of cut (feed) into the tissue being sampled. That is, under the constraint of the connecting member 90, it is achieved that the cutting depth of the rotary cutter 10 in the sampling tissue is equal to the cutting depth of the helical needle 25 in the sampling tissue.

Referring to fig. 3, in a distal to proximal direction, cutter drive assembly 95 is threadably engaged coaxially with the distal end of connector 90, and the proximal end of connector 90 is threadably engaged coaxially with lancing drive assembly 31. The threaded engagement both limits the rotational path of the cutter drive assembly 95 and the lancing drive assembly 31, and improves the coaxiality of the three and reduces errors.

Specifically, referring to fig. 2 and 4, the distal end of the driving core wire 40 is fixedly connected to the needle body 252 of the spiral needle 25, and the proximal end of the driving core wire 40 is fixedly connected to the distal end of the threaded slider 50. The drive core wire 40 is housed within the outer tube 20. The driving core wire 40 can be spirally rotated along the axis of the outer tube 20 in the outer tube 20 under the driving of an external force. The drive core wire 60 may be one of a wire, a steel tube, or a steel wire rope. Because the human body blood vessel is bent and bent, the transmission core wire 60 and the outer tube 20 are matched with the conveying catheter for use, and the transmission core wire has enough flexibility and can conform to the human body blood vessel. For example, for a myocardium biopsy, the rotary cutter 10 and the spiral needle 25 need to pass through the jugular or femoral vein to the right atrium, through the tricuspid valve, and into the right ventricle by means of the driving core wire 40 and the outer tube 20.

Referring to fig. 2, the handle body 70 includes two slide rails 71 and a push-pull ring 73 that are parallel to each other. The two sliding rails 71 are parallel to each other and spaced apart from each other, and converge at the proximal end on the push-pull ring 73. The two sliding rails 71 and the push-pull ring 73 are enclosed to form a containing cavity 74. The distal end of each slide rail 71 includes an assembly head 711 secured to the connector 90.

Referring to fig. 3, in this embodiment, two assembly heads 711 are secured to the proximal end of the connector 90. Specifically, the outer circumferential surface of the assembly head 711 is provided with a limiting groove 7111 as shown in fig. 3a, and the proximal end of the connecting member 90 is clamped in the limiting groove 7111. In other embodiments, the assembly head 711 and the connector 90 may also be secured to each other by other means, such as welding or bonding.

Referring to fig. 2 and 3a, the slide rail 71 has a pair of first stoppers 713 near the distal end of the assembly head 711, and a pair of second stoppers 714 near the proximal end. Correspondingly, the control member 60 is provided with a pair of limit grooves (not shown) corresponding to the first limit buckles 713. The first limiting buckle 713 is engaged with the limiting groove of the control member 60, so as to define a starting point of the movement of the control member 60 on the sliding rail 71, where the control member 60 is stationary relative to the sliding rail 71 due to the first limiting buckle 713. The second stop button 714 is also configured to engage with a stop recess of the control member 60 to define an end point of movement of the control member 60 on the rail 71, where the control member 60 is also stationary relative to the rail 71. Thus, when using the biopsy device 100 to sample, once the pulling control member 60 is separated from the first limit buckle 713 and slides along the sliding rail 71 and the screw 80 to be engaged with the second limit buckle 714, the operator can release the control member 60 without holding the control member all the time, and the sliding rail 71 defines the movement path of the control member 60, so that the spiral needle 25 and the rotary cutter 10 are prevented from being greatly swung in the body due to the violent shaking in the movement process, and the blood vessel and the tissue are damaged.

Referring to fig. 2 and 3, the screw 80 is disposed in the accommodating cavity 74, and has a proximal end rotatably connected to the push-pull ring 73, and a distal end, as shown in fig. 3, sleeved on the outer peripheral surface of the proximal end of the connector 51 of the threaded slider 50 and fixedly connected to the threaded slider 50. When the screw 80 is driven by external force to rotate along its own axis in the accommodating cavity 74, the screw slider 50 is driven to rotate synchronously, so as to control the rotation speed of the screw slider 50.

Referring to fig. 2, the control member 60 includes a control slider 62 and two finger rings 61 connected to the control slider 62 at opposite sides of the control slider 62, respectively. As shown in fig. 5, the control slider 62 has a stop surface 712 for mating with the slide rail 71. As shown in fig. 3 and 6, two slide rails 71 and a screw 80 penetrate the proximal end face and the distal end face of the control slider 62. Thus, when finger ring 61 is pulled from left to right (from the distal end to the proximal end of biopsy device 100) along the plane of the paper as shown in FIG. 2, control slide 62 will slide along slide rail 71 and threaded rod 80 under the restraint of stop surface 712 until it engages second stop button 714 as shown in FIG. 3a, which corresponds to the end point of control slide 62.

The inner surface of the control slider 62, which is in contact with the screw 80, is provided with threads that mate with the screw 80, and the pitch of the threads of the control slider 62 is smaller than the pitch of the threads of the screw 80. When the control slider 62 slides along the slide rail 71 from the start point to the end point, the screw 80 is rotated around its own axis by the control slider 62. When the control slide 62 moves into engagement with the second limit catch 714, the screw 80 stops rotating.

The number of turns of the screw 80 may be correspondingly set by setting the length of the slide rail 71. For example, the displacement of the control slider 62 from the start point to the end point may be set to correspond to three rotations of the screw 80. The number of turns of the screw 80 determines the maximum rotational displacement of the helical needle 25, as well as the amount of feed into the tissue. That is, the maximum rotational displacement of the screw needle 25 can be preset by the screw 80. The number of stripes of the screw 80 may be greater than 2 to make sliding of the control slider 62 along the screw 80 more stable. The screw 80 may be a metal machined part or made of a polymeric material.

With continued reference to fig. 2, the threaded slider 50 includes a body 52 and a connector 51. The two ends of the main body 52 are fixedly connected with the transmission core wire 40 and the connector 51 respectively. The body 52 and the connector 51 are both substantially hollow cylindrical, and the outer circumferential surface of the body 52 is provided with threads having the same pitch as the threads of the helical tip 251, so that the displacement of each advance of the helical needle 25 per rotation is the same as the displacement of each advance of the body 52, ultimately resulting in a constant depth of each access of the helical needle 25 to tissue sampling. As shown in fig. 3, the proximal end of the connector 52 is inserted into the distal end of the screw 80 to socket with the screw 80. In other embodiments of the present invention, the connector 51 may be integrally formed with the body 52.

Referring to fig. 2 and 3, the connector 90 includes a first connection portion 92 and a second connection portion 91 fixedly coupled to a distal end of the first connection portion 92. The connector 90 has a through hole 915 penetrating the first and second connection parts 92 and 91 as shown in fig. 8. Referring to fig. 8, the inner wall of the connection member 90 located in the through hole 915 is provided with threads, and the body 52 of the thread slider 50 and the connection member 90 are engaged with each other in the through hole 915 by the threads. The pitch of the threads of the connection 90 is the same as the pitch of the threads of the thread blocks 50. Referring to fig. 2, 3 and 8, a buckle 921 is disposed in the first connecting portion 92, and the buckle 921 is matched with a limiting groove 7111 on the outer peripheral surface of the connector 711, so that the first connecting portion 92 and the sliding rail 71 are fixedly connected to each other. Further, referring to fig. 8, the distal end of the second connection portion 91 is provided with a first projection 911 in an arc shape located in the through hole 915.

With continued reference to fig. 8, the cutter drive assembly 95 is generally knob-shaped, including a rotating portion 951 and a stop portion 952. The rotating portion 951 is cap-shaped with a conical distal end and a cavity. The proximal end of the outer tube 20 penetrates and is fixed to the rotating portion 951. The distal end of the second coupling part 91 is received in the cavity of the rotating part 951 and is in threaded engagement with the inner surface of the rotating part 951, i.e., the cutter driving assembly 95 and the coupling 90 are rotatably coupled to each other by the threaded engagement. The stopper 952 is located within the cavity of the rotating portion 951, is connected to the conical distal end of the rotating portion 951, and extends proximally. The proximal end of the stopper 952 is provided with a second protrusion 912 having an arc shape. In the natural assembled state of the tissue biopsy device (i.e. the non-operational state), the stop 952 is located in the distal end in the second connection 91.

In the natural assembled state of the tissue biopsy device 100, the distance between the first projection 911 and the second projection 912 in the axial direction of the second connection portion 91 is equal to the maximum rotational displacement of the main body 52 driven by the screw 80. When the cutter driving assembly 95 rotates relative to the second connection portion 91 until the first protrusion 911 and the second protrusion 912 collide, the cutter driving assembly 95 cannot rotate relative to the second connection portion 91 any more. That is, the use of the first projection 911 and the second projection 912 cooperatively presets a maximum rotational displacement of the cutter drive assembly 95 in the axial direction of the link 90 upon rotation of the link 90. The maximum rotational displacement of the cutter driving assembly 95 in the axial direction of the connecting member 90 is preset to be equal to the maximum rotational displacement of the thread slider 50 driven by the screw 80.

Referring to fig. 3, the proximal end of the outer tube 20 is secured to the cutter drive assembly 95, and the proximal end of the transmission core wire 40 is secured to the body 52 of the threaded slider 50 after passing through the cutter drive assembly 95. Because the cutter driving assembly 95 is screw-engaged with the second coupling portion 91, when the cutter driving assembly 95 is screw-rotated distally around the second coupling portion 91 until the first projection 911 and the second projection 912 collide with each other, the outer tube 20 and the rotary cutter 10 are screw-rotated distally to the maximum rotational displacement.

When using the biopsy device 100 to sample soft tissue in vivo, once the blade edge of the rotary cutter 10 reaches the sampling position, the penetration drive assembly 31 is first activated to drive the helical tip 251 to rotate until it reaches its maximum rotational displacement.

Specifically, referring to fig. 3 and fig. 6 together, pulling the finger ring 61 proximally along the horizontal direction, the control member 60 will disengage from the first limiting buckle 713, and pulling the finger ring 61 continuously causes the control member 60 to slide along the sliding rail 71 until the control slider 62 engages with the second limiting buckle 714. It will be appreciated that while the control member 60 is sliding, the screw 80 will rotate about its own axis by the control member 60, as the pitch of the screw threads of the control member 60 is less than the pitch of the screw threads of the screw 80. Since the connecting member 90 constrains the connecting head 711 of the sliding rail 71 and the threaded slider 50, and the distal end of the screw 80 is fixedly connected to the proximal end of the threaded slider 50, the threaded slider 50 will rotate around its own axis under the driving of the screw 80, driving the driving core wire (not shown) to advance distally. Further, the spiral needle 25 is advanced distally by the drive core wire until a maximum rotational displacement is reached, at which point the rotation is stopped. It will be appreciated that the sampling depth of the helical needle 25 into the tissue is equal to the predetermined maximum rotational displacement.

The cutter drive assembly 95 is then activated to drive the rotary cutter 10 distally until it reaches a maximum rotational displacement.

Specifically, the cutter driving assembly 95 is rotated distally along the outer circumferential surface of the second coupling portion 91. It will be appreciated that the second projection 912 on the cutter drive assembly 95 as shown in figure 8 will be adjacent to the first projection 911 on the second connector 91 until the two abut as shown in figure 9. At this point, the cutter drive assembly 95 will no longer be able to rotate distally. In this process, since the outer tube 20 is fixedly connected to the cutter driving assembly 95, the rotary cutter 10 at the distal end of the outer tube 20 is driven by the outer tube 20 to be spirally advanced toward the distal end. Since the initial distance between the first projection 911 and the second projection 912, i.e., the distance by which the second projection 912 rotates toward the first projection 911 is equal to the maximum rotational displacement of the screw needle 25, the rotary cutter 10 will also be helically advanced distally by the maximum rotational displacement as shown in fig. 9. Since the cutting edge 101 of the rotary cutter 10 and the needle tip 2511 of the spiral needle 25 are flush in the initial state, both have the same rotation start point, and the maximum rotational displacement of the spiral needle 25 and the rotary cutter 10 is equal, the rotary cutter 10 and the spiral needle 25 have the same rotation end point, and the depth of cutting tissue is the same as the depth of screwing the spiral needle 25 into tissue.

After the rotary cutter 10 rotates the tissues, the push ring 73 is held, and the outer tube 20 and the rotary cutter 10 are withdrawn from the body. It will be appreciated that the helical needle 25 will be positioned within the outer tube 20 during operation of the rotary cutter 10, thereby avoiding inadvertent contact of the helical needle 25 with other tissue.

In contrast to the prior art, the tissue biopsy device 100 provided by the present invention has the following advantages:

firstly, the biopsy device can be positioned by pulling the control slide block 62 to the movement end point and penetrating into tissues by using the spiral needle 25, and the clamp is spread without the need of pressing the spring button by fingers all the time, so that the operation is convenient and labor-saving, and the operation time is shortened.

Next, the maximum rotational displacement of the screw needle 25 is directly controlled by presetting the number of rotations of the screw 80, without requiring an operator to empirically control the gripping depth and the sampling amount of the screw needle 25 at the time of sampling. In addition, the maximum rotation displacement of the spiral needle 25 and the rotary cutter 10 is preset to be equal, and the size of the spiral needle 25 and the size of the rotary cutter 10 are constant, so that the size of each sampling can be controlled to be uniform, quantitative sampling is realized, and the defect that the sample amount is not grabbed enough is avoided.

Then, the rotary cutter 10 is controlled to rotate to cut the tissue through the cutter driving assembly 95, the depth of the cut tissue is limited in advance by the distance between the first protrusion 911 and the second protrusion 912, and the operator can directly rotate the cutter driving assembly 95 in place to cut the tissue to be free to drop off, so that the operation is convenient.

In addition, the maximum rotational displacement (depth of cut tissue) of the rotary cutter 10 is equal to the maximum rotational displacement (depth of screw in tissue) of the screw needle 25, and the tip 2511 of the screw needle 25 has the same rotational origin as the blade edge 101 of the rotary cutter 10, ensuring that the rotary cutter 10 can rotary cut the non-peeled myocardium to the same depth as the capture depth of the screw needle 25, and thus, the sampled tissue can be freely detached, avoiding tearing of the tissue, and avoiding the risk of cutting through the tissue.

Finally, in the puncture driving assembly 100, the sliding rail 71 is adopted to limit the movement track of the screw 80 and the control member 60, and the connecting piece 90 is adopted to limit the movement track of the cutter driving assembly 95, so that the screw 80 and the control member 60 move stably, further the rotation of the spiral needle 25 connected with the threaded slider 50, the outer tube 20 connected with the cutter driving assembly 95 and the rotary cutter 10 in the body can be stable, the serious fluctuation of the distal end part of the tissue biopsy device in the body can be avoided, and further the damage to blood vessels can be avoided.

It should be noted that other embodiments of the present invention provide a tissue biopsy device that may not include a drive core wire 60 when there is no high requirement for compliance of the biopsy device to sample epidermal tissue or to sample specific tissue in the body without remote delivery of the device through the body vessel. Correspondingly, the proximal end of the spiral needle 25 is directly connected with the thread slider 50, and the thread slider 50 drives the proximal end of the spiral needle 25 to rotate and advance, so as to drive the spiral tip 251 to rotate.

In one variation of the tissue biopsy device provided in this embodiment, the drive of the threaded slider 50 in the lancing drive assembly 31 may be accomplished using other configurations. As one example of the manner in which the objects of the present invention may be achieved, the proximal end of the threaded slider 50 may be directly connected to a drive assembly similar to the connector 90 and the cutter drive assembly 95. By presetting the maximum rotational displacement of the drive assembly to be the same as the maximum rotational displacement of the rotary cutter 10, the distal rotation of the drive assembly directly to its maximum rotational displacement can be accomplished by rotating the threaded slider 50 distally also a distance equal to the maximum rotational displacement.

Further, in another modified structure of the tissue biopsy device provided in the present embodiment, in the initial state, the needle tip 2511 of the spiral needle 25 is not flush with the blade edge 101 of the rotary cutter 10, as long as the maximum rotational displacement of the spiral needle 25 and the rotary cutter 10 is set in advance by the connecting member 90 and the screw 80, respectively, according to the distance difference between the needle tip 2511 and the blade edge 101 in the axial direction, so that the needle tip 2511 can be flush with the blade edge 101 when both the spiral needle 25 and the rotary cutter 10 are located at the maximum rotational displacement thereof, thereby making the depth of embedding of the spiral needle 25 and the rotary cutter 10 into the tissue the same.

The second preferred embodiment of the present invention provides a tissue biopsy device having a structure similar to that of the tissue biopsy device 100, except that the outer circumferential surface of the main body 252 of the spiral needle 25 is provided with threads as shown in fig. 10. As shown in fig. 11, the body 252 is engaged with the screw thread of the rotary cutter 10, that is, the screw pitch of the screw thread of the body 252 is equal to the screw pitch of the screw thread of the rotary cutter 10. Thus, the screw 251 is rotatably coupled to the rotary cutter 10 through the main body 252, and the rotational displacement of the rotary cutter 10 coincides with the rotational displacement of the main body 252 by the rotation of the main body 252. The pitch of the thread of the outer circumferential surface of the main body 252 is also the same as that of the thread of the spiral tip 251. In addition, the structure of the rest of the components of the tissue biopsy device of the present embodiment and the mutual positional relationship and connection relationship between the components are referred to the related drawings and the text description of the first embodiment, and will not be described herein.

In this embodiment, the rotary cutter 10 is screwed with the spiral needle 25, so that the spiral needle 25 is restricted from rotating only to perform the rotary advancement. Similarly, the rotary cutter 10 can only rotate to achieve rotary cutting and advance synchronously.

For applications requiring remote delivery of the distal structure of the biopsy device to tissue sampling within the body, the outer tube 20 may need to conform to the curvature of the vessel to accommodate the curvature during delivery. Because the outer tube 20 is connected to both the helical needle 25 and the rotary cutter 10, the body 252 constrains the movement of the helical needle 25 and the rotary cutter 10. If the outer circumferential surface of the main body 252 is not threadedly engaged with the rotary cutter 10, it may occur that the helical needle 25 cannot protrude from the rotary cutter 10 or protrudes from the rotary cutter 10 by less than a predetermined maximum rotational displacement due to the adaptation of the outer tube 20 to the bending of the blood vessel. Thus, by the threaded engagement of the rotary cutter 10 with the helical needle 25, the relative positions of the helical needle 25 and the rotary cutter 10 will remain unchanged throughout even if the outer tube 20 and the driving core wire 60 conform to the compliant bending of the blood vessel. Furthermore, the tissue biopsy device provided in this embodiment can effectively avoid the variation of the strokes of the spiral needle 25 and the rotary cutter 10 caused by the bending of the outer tube 20 and the transmission core wire 60 in the blood vessel, and further improve the cutting accuracy of the biopsy device.

The foregoing description of the preferred embodiments of the present invention should not be construed as limiting the scope of the invention, but rather should be understood to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the following description and drawings or any application directly or indirectly to other relevant art(s).

Claims

1. A tissue biopsy device, comprising:

an outer tube;

a rotary cutter fixed at the distal end of the outer tube;

the spiral needle is rotatably accommodated in the rotary cutter;

the puncture driving assembly is connected with the spiral needle, and the spiral needle is adapted to rotate spirally under the driving of the puncture driving assembly;

the cutter driving assembly is connected with the outer tube, and the outer tube is adapted to drive the rotary cutter to rotate spirally under the driving of the cutter driving assembly; and

and the spiral needle and the rotary cutter are adapted to be embedded into the tissue to the same depth under the constraint of the connecting piece.

2. The tissue biopsy device of claim 1, wherein the connector is threadably engaged coaxially with the penetration drive assembly and the cutter drive assembly, respectively, the helical needle and the cutter drive assembly being adapted to be helically rotated relative to the connector, respectively, until a maximum rotational displacement thereof is reached.

3. The tissue biopsy device of claim 2, wherein the connector has a first protrusion and the cutter drive assembly has a second protrusion, the cutter drive assembly helically rotating relative to the connector until the rotary cutter reaches its maximum rotational displacement when the first protrusion abuts the second protrusion.

4. The tissue biopsy device of claim 3, wherein the connector has a throughbore therethrough at a proximal end and a distal end, the cutter drive assembly threadably engaging the outer peripheral surface of the connector; the puncture driving assembly is in threaded engagement with the connecting piece in the through hole.

5. The tissue biopsy device of claim 3, wherein the penetration drive assembly comprises a screw, a control slide, and a threaded slide, the screw adapted to rotate about its axis under the control slide during sliding of the control slide from a start point to an end point; the distal end of the thread slider is connected with the spiral needle, and the proximal end of the thread slider is connected with the screw rod; the threaded slider is in threaded engagement with the connector, the threaded slider being adapted to rotate relative to the connector upon rotation of the screw until the helical needle reaches its maximum rotational displacement.

6. The tissue biopsy device of claim 5, wherein the thread of the thread slider has a thread pitch equal to a thread pitch of the thread of the helical needle.

7. The tissue biopsy device of claim 5, wherein the penetration drive assembly further comprises two mutually parallel slide rails, the two slide rails and the screw rod extend through the control slide block, the screw rod is disposed between the two slide rails and parallel to the slide rails, the two slide rails are provided with a first limit button at the starting point and a second limit button at the ending point, and the control slide block is detachably limited on the slide rails through the first limit button and the second limit button, respectively.

8. The tissue biopsy device of claim 7, wherein the cutter drive assembly comprises a stop and a rotating portion having a lumen, the rotating portion threadably engaging the distal end of the connector, the proximal end of the outer tube fixedly secured to the rotating portion, the stop positioned within the rotating portion and extending proximally from the rotating portion, the first protrusion positioned at the distal end of the connector, and the second protrusion positioned at the proximal end of the stop.

9. The tissue biopsy device of claim 7, wherein the connector comprises a first connector portion and a second connector portion coupled to a distal end of the first connector portion, the first connector portion being fixedly coupled coaxially with the distal end of the slide, the rotatable portion being threadably engaged with an outer peripheral surface of the second connector portion, the stop portion being located within the distal end of the second connector portion.

10. The tissue biopsy device of claim 1, wherein the helical needle is threadably engaged with the rotary cutter.

11. The tissue biopsy device of claim 10, wherein the tip of the helical needle is flush with the edge of the rotary cutter, the helical needle and the rotary cutter having equal maximum rotational displacement.

12. The tissue biopsy device of claim 5, wherein the penetration drive assembly further comprises a drive core wire received within the outer tube and having distal and proximal ends fixedly coupled to the helical needle and the threaded slider, respectively.

13. The tissue biopsy device of claim 7, wherein the penetration drive assembly further comprises a push pull ring, the proximal ends of the two slide rails converging to the push pull ring.