CN111449692B

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Info

Publication number: CN111449692B
Application number: CN202010328954.0A
Authority: CN
Inventors: 肖波; 刘长庚; 唐为忠
Original assignee: Sonic Biotechnology Shanghai Co ltd
Current assignee: Sonic Biotechnology Shanghai Co ltd
Priority date: 2020-04-23
Filing date: 2020-04-23
Publication date: 2021-03-19
Anticipated expiration: 2040-04-23
Also published as: CN111449692A

Abstract

The invention provides an inner core, wherein a protection part is arranged at the proximal end of the inner core, an operation part is arranged at the distal end of the inner core, the protection part comprises a cap structure and a lock structure, the protection part enters the needle tip part through the distal end of a biopsy needle and carries out rotary motion and axial motion under the driving of the operation part, when the lock structure is blocked by the needle tip part to stop the motion relative to the biopsy needle, the cap structure covers the front end inclined plane, the needle tip of the biopsy needle is favorably covered in the process that the biopsy needle does not need sampling operation, and therefore the damage of the biopsy needle to a non-sampling part is avoided.

Description

Inner core and biopsy device

Technical Field

The invention relates to the technical field of medical instruments, in particular to an inner core and a biopsy device.

Background

Needle biopsy is a common approach for tumor therapy, and after a biopsy needle is inserted into a diseased region, a part of the diseased tissue is taken out for subsequent pathological analysis, and the finally adopted treatment scheme depends on the result of the pathological analysis. Therefore, the prior art generally locates the lesion region by cooperating the needle biopsy process with the medical imaging device to improve the accuracy of the pathological analysis result.

The biopsy needle in the prior art is generally sheathed with a sheath, and the sheath firstly enters a human body to form an intervention channel before biopsy puncture is carried out; during biopsy puncture, the biopsy needle enters the human body along the extending direction of the sheath and extends out of the end surface of the sheath, so that the puncture tip of the biopsy needle acts on the target tissue and obtains a tissue sample. However, with the above-described structure, the puncture tip of the biopsy needle easily scratches the inner wall of the sheath, thereby contaminating the sample.

Chinese patent publication No. CN106456142B discloses an endoscopic puncture needle in which a stylet inserted into a needle tube is provided as an inner core of a biopsy needle so that a needle tip is hard to penetrate into a sheath, a free end of the stylet is formed in a convex-like hemispherical shape, and the stylet is operated so that an end face of the free end thereof comes into contact with an inner surface of the sheath formed in a curved shape, thereby preventing the puncture tip of the biopsy needle from scratching the sheath. However, when the biopsy needle extends out of the end face of the sheath for sampling, the direction of the biopsy needle is weakly controlled by the through tube wire, and the biopsy needle easily punctures a non-sampling part in the sampling process, so that unnecessary damage is caused to a human body.

Therefore, there is a need for a new type of core that avoids the above-mentioned problems of the prior art.

Disclosure of Invention

The invention provides an inner core used with a biopsy needle and a biopsy device comprising the inner core, so as to avoid the biopsy needle from damaging a non-sampling part.

The biopsy needle comprises a needle tip part formed by enclosing an opening inclined plane and a hollow tube, wherein the opening inclined plane comprises a front end inclined plane, and a needle point is formed on the front end inclined plane.

In order to achieve the above purpose, the inner core of the present invention has a protection portion at a proximal end thereof, and an operation portion at a distal end thereof, wherein the protection portion includes a cap structure and a lock structure, the protection portion enters the needle tip portion through the distal end of the biopsy needle, and is driven by the operation portion to perform a rotational movement and an axial movement, so that the lock structure is in different position states relative to the biopsy needle, and the different position states include a protection state and a withdrawing state; when the lock structure is in the protection state, the lock structure is blocked by the needle tip part to stop moving relative to the biopsy needle, and the cap structure covers the front end bevel; when the lock structure is in the withdrawing state, the protection part is contained in the biopsy needle under the driving of the operation part and is far away from the needle tip part, so that the biopsy sampling is prepared.

The inner core has the beneficial effects that: the near-end of inner core is provided with the protection portion, and the distal end is provided with the operation portion, the protection portion includes cap structure and lock structure, the protection portion passes through the distal end entering of biopsy needle inside the needle point portion, and carry out rotary motion and axial motion under the drive of operation portion, make and work as the lock structure quilt the needle point portion blocks in order to stop relatively the motion of biopsy needle, cap structure cladding the front end inclined plane is favorable to the biopsy needle does not need the in-process of sample operation with the needle point cladding of biopsy needle is got up to avoid the biopsy to cause the damage to non-sample location.

Preferably, after the lock structure releases the protection state by the axial movement, the protection portion rotates about the rotation axis by 30 to 330 degrees and moves toward the distal end of the biopsy needle by the axial movement to place the lock structure in the withdrawal state. The beneficial effects are that: is beneficial to the sampling process of the biopsy needle and avoids scratching the non-sampling part.

Further preferably, the operation portion is provided coaxially with the biopsy needle. The beneficial effects are that: facilitating the stabilization of the rotational movement.

Further preferably, the lock structure is arranged in the cap structure, and the lock structure is clamped with the needle tip part to be in the protection state. The beneficial effects are that: the structure is simple, and the lock structure can be rapidly in the protection state and the quitting state.

Further preferably, the lock structure includes a limiting member, the limiting member is disposed on the cap structure and inclined to the axis of the needle tip portion to form an opening structure with the cap structure, and the opening structure is clamped to the needle tip portion to enable the lock structure to be in the protection state.

Further preferably, the cap structure includes a curved member, one end of the curved member is open, and when the lock structure is in the protection state, the front end inclined plane is accommodated in a space defined by the curved portion through the opening of the curved member so as to cover the needle point.

Further preferably, the front end bevel includes a first outer edge and a second outer edge, the first outer edge and the second outer edge meet to form the needle tip, the bending member includes a concave region facing the front end bevel, and a distance between any one of the first outer edge and the second outer edge and a surface of the concave region is greater than 0.

Further preferably, the region of the curved part facing the front end bevel is attached to the front end bevel to cover the needle tip.

It is further preferred that the inner core comprises a first connector attached to one end of the cap structure and extending towards the distal end of the biopsy needle for attachment to the handle portion.

Further preferably, the first connector and the cap structure form a hook-like structure.

It is further preferred that a second connecting member is provided, which is connected to the other end of the cap structure and extends toward the distal end of the biopsy needle to be connected to the operation portion.

The biopsy device comprises a biopsy needle and the inner core, wherein a protection part is formed at the proximal end of the inner core, an operation part is formed at the distal end of the inner core, and the protection part enters the biopsy needle through the distal end of the biopsy needle and is driven by the operation part to perform axial movement and rotary movement.

Preferably, the biopsy needle comprises a needle tip portion and a needle shaft portion which are sequentially connected, the needle tip portion converges toward the central axis of the needle shaft portion, and the opening inclined plane of the needle tip portion crosses the central axis of the needle shaft portion.

Further preferably, the wall thickness of the proximal end of the needle rod part is greater than the wall thickness of the distal end of the needle tip part, and the inner diameter of the needle tip part is not less than the inner diameter of the needle rod part.

Drawings

FIG. 1 is a schematic view of an assembled structure of the inner core and the biopsy needle of the present invention;

FIG. 2 is a schematic diagram of the exploded structure of FIG. 1;

FIG. 3 is a schematic view of the needle tip and the protection portion shown in FIG. 2;

FIG. 4 is a schematic view of the needle tip portion and the protection portion shown in FIG. 2 in another operation state;

FIG. 5a is a schematic structural view of a flexure according to some embodiments of the present invention;

FIG. 5b is a schematic structural view of a flexure according to further embodiments of the present invention;

FIG. 6 is an assembled schematic view of the first connector, second connector and cap structure of the present invention;

FIG. 7 is an internal schematic view of the needle tip portion and second needle shaft configuration of FIG. 2;

fig. 8 is another internal view of the structure formed by the needle tip portion and the second needle shaft shown in fig. 2.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings of the present invention, and it is obvious that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention. Unless defined otherwise, technical or scientific terms used herein shall have the ordinary meaning as understood by one of ordinary skill in the art to which this invention belongs. As used herein, the word "comprising" and similar words are intended to mean that the element or item listed before the word covers the element or item listed after the word and its equivalents, but does not exclude other elements or items.

In order to solve the problems in the prior art, embodiments of the present invention provide an inner core and a biopsy device including the inner core and a biopsy needle, so as to prevent the biopsy needle from damaging a non-sampling portion.

In the embodiment of the invention, the near end is defined as the end which is firstly contacted with the human body or is closest to the human body in the operation process.

Fig. 1 is a schematic view of an assembly structure of the inner core and the biopsy needle according to some embodiments of the present invention. Fig. 2 is a schematic diagram of the exploded structure of fig. 1.

Referring to fig. 1 and 2, theinner core 10 is partially received in thebiopsy needle 20. Thebiopsy needle 20 includes aneedle shaft portion 21 and aneedle tip portion 22 that are sequentially connected. The proximal end of theinner core 10 is provided with aprotection part 12, the distal end is provided with anoperation part 11, theprotection part 12 enters the interior of theneedle tip part 22 through the distal end of thebiopsy needle 20, and the protection part moves relatively under the driving of theoperation part 11. The relative movement includes rotational movement and axial movement.

Wherein the movement in the direction of extension of thebiopsy needle 20 is the axial movement, in particular comprising: a movement of pushing theoperation part 11 to move theprotection part 12 away from the distal end of thebiopsy needle 20, and a withdrawal of theoperation part 11 to move theprotection part 12 toward the distal end of thebiopsy needle 20.

The rotational movement takes place about a rotational axis, which is the axis of theinner core 10. In some embodiments of the present invention, referring to fig. 2, the axis ofrotation 14 is the central axis of thecore 10.

In some embodiments of the present invention, theguard portion 12 is rotated about therotational axis 14 by 30-330 degrees to complete the rotational movement.

Referring to fig. 2, theinner core 10 includes afirst connector 13, and thefirst connector 13 is connected to theprotection portion 12 and extends toward the distal end of thebiopsy needle 20 to be connected to theoperation portion 11. The first connectingmember 13 and the cap structure (not shown) of the protectingportion 12 form a hook structure.

In some embodiments of the present invention, the first connectingmember 13 is a metal spring tube.

In some embodiments of the present invention, the first connectingmember 13 is made of any one of polyetheretherketone, carbon fiber high density PE, and hard nylon to effectively support thebiopsy needle 20.

In an embodiment of the present invention, referring to fig. 1, before thebiopsy needle 20 enters the access channel, theinner core 10 is operated to cover the puncture tip of thebiopsy needle 20, so as to avoid damage to the access channel caused by the movement of thebiopsy needle 20 in the access channel.

Fig. 3 is a schematic view of the needle tip and the protection portion shown in fig. 2 in an operating state. Fig. 4 is another schematic view of the needle tip and the protection portion shown in fig. 2.

Referring to fig. 3, theprotective portion 12 comprises alock structure 33 and acap structure 34, thelock structure 33 being capable of different position states relative to thebiopsy needle 20, the different position states comprising a protective state and a withdrawn state.

Specifically, referring to fig. 2, theoperation portion 11 is pushed in the extending direction of thebiopsy needle 20 so that theprotection portion 12 protrudes out of the opening of theneedle tip portion 22 and is away from theneedle tip portion 22 as far as possible, and then performs counterclockwise rotational movement about thecentral axis 14 in the a direction shown in fig. 2.

When theprotection portion 12 is rotated by 180 degrees counterclockwise around therotation axis 14 from the position state shown in fig. 2, theoperation portion 11 is withdrawn in the extending direction of thebiopsy needle 20 to move theprotection portion 12 toward the distal end of thebiopsy needle 20.

Referring to fig. 3, after the protectingportion 12 contacts theneedle tip 22, thelock structure 33 is blocked by theneedle tip 22 to stop the movement relative to the biopsy needle (not shown), and thecap structure 34 covers the front slope of thebiopsy needle 20 to keep thelock structure 33 in the protecting state, so as to avoid damage to the access channel during the movement of thebiopsy needle 20 in the access channel.

In an embodiment of the present invention, referring to fig. 1, when the target tissue is located and a sampling operation through thebiopsy needle 20 is required, theinner core 10 is operated to uncover the puncture tip of thebiopsy needle 20, and theinner core 10 is moved towards the distal end of thebiopsy needle 20 to facilitate the sampling operation performed by thebiopsy needle 20.

Specifically, referring to fig. 2 and 3, theoperation portion 11 is pushed in the extending direction of thebiopsy needle 20 to make theprotection portion 12 away from theneedle tip portion 22, so that thelock structure 33 is released from the protection state; then, theoperation portion 11 is operated to rotate theprotection portion 12 clockwise by 180 degrees in the B direction shown in fig. 3 about therotation axis 14.

Referring to fig. 2 and 4, after theoperation portion 11 rotates theprotection portion 12 clockwise by 180 degrees around therotation axis 14 in the direction B shown in fig. 3, and then withdraws theoperation portion 11 in the extending direction of thebiopsy needle 20 so that theprotection portion 12 is accommodated in theneedle tip portion 22 and thelock structure 33 is in the withdrawing state, theprotection portion 12 moves toward the distal end of thebiopsy needle 20 to be away from theneedle tip portion 22, thereby facilitating the sampling operation of thebiopsy needle 20.

In some embodiments of the present invention, referring to fig. 2, theoperation portion 11 and thebiopsy needle 20 are coaxially disposed to facilitate stabilizing the rotational movement.

In some embodiments of the present invention, thelock structure 33 is disposed on thecap structure 34 and is clamped with theneedle tip 22 to be in the protection state.

Specifically, thelock structure 33 includes a limiting member disposed on thecap structure 34.

More specifically, the stop comprises a thorn-like structure.

In some embodiments of the present invention, thecap structure 34 comprises a curved member, one end of the curved member is open, and when thelock structure 33 is in the protection state, the front end bevel is received in a space defined by the curved member through the opening of the curved member to cover the needle tip.

FIG. 5a is a schematic structural view of a flexure according to some embodiments of the present invention.

Referring to fig. 5a, aconcave surface 51, afirst end surface 53, aconvex surface 52 and a second end surface (not shown) are connected in sequence, theconcave surface 51 is opposite to theconvex surface 52, and thefirst end surface 53 is opposite to the second end surface (not shown) to form the bendingmember 5.

A firsttangent plane 541 is formed from one end of the bendingmember 5 along a direction parallel to thefirst end surface 53, and a secondtangent plane 542 is formed along a direction oblique to therotation axis 14, and an opening structure formed by the intersection of the firsttangent plane 541 and the secondtangent plane 542 is thelock structure 33.

Thelock structure 33 includes a stopper (not shown) disposed on thecap structure 34. Specifically, referring to fig. 5a, the limiting element (not shown) is a thorn-shaped structure formed by the intersection of the secondtangent plane 542, theconcave surface 51, theconvex surface 52 and the second end surface (not shown). The limiting member (not labeled) is disposed obliquely to therotation axis 14 to form an opening structure with the bendingmember 5, and therotation axis 14 is a central axis of thecap structure 34.

Specifically, the opening structure is a V-shaped opening.

In some embodiments of the present invention, the opening structure is a U-shaped opening.

Referring to fig. 3, theneedle tip portion 22 is surrounded by ahollow tube 31 and an openingslope 32, and the openingslope 32 includes the front end slope (not shown). An opening structure (not shown) formed by thelock structure 33 is clamped on two sides of the openinginclined plane 32, so that thelock structure 33 is in the protection state, and meanwhile, thecap structure 34 covers the front end inclined plane (not shown) of theneedle point portion 22, so as to prevent the puncture tip of theneedle point portion 22 from damaging the interventional channel.

In some embodiments of the present invention, a region of the curved member facing the front end bevel is attached to the front end bevel to cover the needle tip.

Specifically, referring to fig. 4 and 5a, theconcave surface 51 is adapted to the openingslope 32, and the curvature of theconcave surface 51 at least corresponds to the curvature of the front slope (not shown) to fit the front slope (not shown).

In some embodiments of the present invention, referring to fig. 4, the front end of thebevel opening 32 is formed with a firstouter edge 41 and a secondouter edge 42, the firstouter edge 41 and the secondouter edge 42 meet to form the tip of thetip portion 22, and thebevel opening 32 meets the inner sidewall of thetip portion 22 at aninner edge 43.

Specifically, the front bevel includes a region located on the axial side of theneedle tip portion 22 and defined by theinner edge 43, the firstouter edge 41, and the secondouter edge 42.

FIG. 5b is a schematic view of a flexure of further embodiments of the present invention.

Referring to fig. 5a and 5b, the surface of theconcave surface 51 of the bending member shown in fig. 5b is further formed with aconcave region 511, compared to the bendingmember 5 shown in fig. 5 a.

In some embodiments of the present invention, the front end bevel is received in theconcave region 511, so that the distance between any one of the firstouter edge 41 and the secondouter edge 42 and the surface of theconcave region 511 is greater than 0.

In some embodiments of the invention, the core 10 further comprises a second connector.

FIG. 6 is an assembly view of a first connector, a second connector, and a cap structure according to some embodiments of the invention.

Referring to fig. 2 and 6, a second connectingmember 61 is connected to the other end of thecap structure 34 and extends toward the distal end of thebiopsy needle 20 to be connected to the operatingportion 11.

In some embodiments of the present invention, the second connectingmember 61 is a metal spring tube.

In some embodiments of the present invention, the second connectingmember 61 is made of any one of polyetheretherketone, carbon fiber high density PE, and hard nylon to effectively support thebiopsy needle 20.

Referring to fig. 2 and 3, thehollow tube 31 is a bent tube, such that theneedle tip portion 22 converges toward the central axis (not labeled) of theneedle shaft portion 21, such that when thecap structure 34 covers the front end slope of theneedle tip portion 22, the maximum radial length of the structure formed by thecap structure 34 and theneedle tip portion 22 along the direction perpendicular to the central axis of theneedle shaft portion 21 is also smaller than the outer diameter of theneedle shaft portion 21. Therefore, with theinner core 10 of the embodiment of the present invention, on one hand, a supporting function can be provided for thebiopsy needle 20, and on the other hand, the front end bevel of theneedle tip 22 can be effectively covered without sheathing a sheath on the outside of thebiopsy needle 20, so as to avoid the damage of thebiopsy needle 20 to the access passage, and further facilitate the application of the small-sized access passage.

In some embodiments of the present invention, the open bevel of theneedle tip 22 is located across the central axis of theneedle shaft 21. The wall thickness of the proximal end of theneedle rod part 21 is larger than that of the distal end of theneedle tip part 22, and the inner diameter of theneedle tip part 22 is not smaller than that of theneedle rod part 21.

Referring to fig. 2, theneedle bar portion 21 has afirst needle bar 211 and asecond needle bar 212 which are connected in series.

Fig. 7 is an internal view of the structure formed by the needle tip portion and the second needle shaft shown in fig. 2. Fig. 8 is another internal view of the structure formed by the needle tip portion and the second needle shaft shown in fig. 2.

Referring to fig. 7, thesecond needle shaft 212 has a uniform inner diameter and outer diameter, the inner diameter of thehollow tube 31, i.e., the radial length defined between the inner side walls of thehollow tube 31, is equal to the inner diameter of thesecond needle shaft 212, and the thickness of thehollow tube 31 is continuously reduced, so that the tip (not shown) formed by the intersection of the openingslope 32 and the outer side wall of thehollow tube 31 has a small contact area, while the amount of tissue sample acquisition is increased, so as to increase the puncture strength of theneedle tip 22 in the subsequent application process.

Thehollow tube 31 shown in fig. 8 can be formed by further reducing the wall thickness of thehollow tube 31 by milling on the basis of the hollow tube shown in fig. 7, so that thehollow tube 31 has a continuously increasing inner diameter, and the inner diameter of thehollow tube 31 is not smaller than the inner diameter of thesecond needle shaft 212 and the sampling amount is further increased.

Although the embodiments of the present invention have been described in detail hereinabove, it is apparent to those skilled in the art that various modifications and variations can be made to these embodiments. However, it is to be understood that such modifications and variations are within the scope and spirit of the present invention as set forth in the following claims. Moreover, the invention as described herein is capable of other embodiments and of being practiced or of being carried out in various ways.

Claims

1. The utility model provides an inner core for cooperating the biopsy needle use, the biopsy needle includes the pinpoint portion that is enclosed to establish with the hollow tube by the opening inclined plane, the opening inclined plane includes the front end inclined plane, the front end inclined plane is formed with needle point, its characterized in that:

the proximal end of the inner core is provided with a protection part, the distal end of the inner core is provided with an operation part, and the protection part comprises a cap structure and a lock structure;

the protection part enters the needle tip part through the distal end of the biopsy needle and is driven by the operation part to perform rotary motion and axial motion so as to enable the lock structure to be in different position states relative to the biopsy needle, and the different position states comprise a protection state and a quitting state;

when the lock structure is in the protection state, the lock structure is blocked by the needle tip part to stop the movement relative to the biopsy needle, and the cap structure at least covers the front end bevel;

when the lock structure is in the withdrawing state, the protection part is contained in the biopsy needle under the driving of the operation part and is far away from the needle tip part so as to prepare for biopsy sampling;

after the lock structure releases the protection state through the axial movement, the protection part rotates around the rotation axis by 30-330 degrees and moves towards the distal end of the biopsy needle through the axial movement so as to enable the lock structure to be in the withdrawing state;

the operating part and the biopsy needle are coaxially arranged, the lock structure is arranged on the cap structure, and the lock structure is clamped with the needle tip part to be in the protection state;

the cap structure comprises a curved piece, one end of the curved piece is opened, and when the lock structure is in the protection state, the front end inclined plane is contained in a space limited by the curved piece through the opening of the curved piece so as to cover the needle point.

2. The inner core according to claim 1, wherein the lock structure comprises a limiting member disposed on the cap structure and inclined to an axis of the needle tip portion to form an opening structure with the cap structure, and the opening structure is engaged with the needle tip portion to keep the lock structure in the protection state.

3. The inner core of claim 2, wherein the front end bevel comprises a first outer edge and a second outer edge that meet to form the needle tip, the flexure comprises a recessed region facing the front end bevel, and either of the first outer edge and the second outer edge is a distance greater than 0 from a surface of the recessed region.

4. The inner core according to claim 2, wherein the region of the curved member facing the front bevel abuts the front bevel to cover the needle tip.

5. The inner core of claim 1, comprising a first connector coupled to an end of the cap structure and extending toward a distal end of the biopsy needle for coupling to the handle portion.

6. The core as set forth in claim 5 wherein said first connector and said cap structure form a hook-like structure.

7. The inner core of claim 6, further comprising a second connector interfacing with the other end of the cap structure and extending toward the distal end of the biopsy needle to interface with the handle portion.

8. A biopsy device comprising a biopsy needle and an inner core according to any one of claims 1-7, wherein the inner core is formed with a protection portion at a proximal end and an operation portion at a distal end, and the protection portion enters the biopsy needle through the distal end of the biopsy needle and is driven by the operation portion to perform axial and rotational movements.

9. The biopsy device of claim 8, wherein the biopsy needle comprises a needle tip portion and a needle shaft portion in series, the needle tip portion converging toward a central axis of the needle shaft portion, an open bevel of the needle tip portion spanning the central axis of the needle shaft portion.

10. The biopsy device of claim 9, wherein a proximal wall thickness of the shaft portion is greater than a distal wall thickness of the needle tip portion, the needle tip portion having an inner diameter no less than an inner diameter of the shaft portion.