CN113116502A

CN113116502A - Puncture needle assembly and ablation needle assembly

Info

Publication number: CN113116502A
Application number: CN201911422457.0A
Authority: CN
Inventors: 丘信炯; 彭波波; 王柏栋; 刘丽文; 胡芮
Original assignee: Hangzhou Nuo Cheng Medical Instrument Co ltd
Current assignee: Hangzhou Nuo Cheng Medical Instrument Co ltd
Priority date: 2019-12-30
Filing date: 2019-12-30
Publication date: 2021-07-16

Abstract

The invention provides a puncture needle assembly and an ablation needle assembly, wherein the puncture needle assembly comprises: the puncture needle tube comprises a hollow tube body and a tube seat fixedly connected with one end of the tube body, wherein the inner cavity of the tube seat is communicated with the inner cavity of the tube body; the sealing element at least comprises an elastic sealing diaphragm, and the outer peripheral surface of the sealing diaphragm is attached to the inner wall of the inner cavity of the tube seat; the puncture needle core is detachably connected with the tube seat, the needle point of the puncture needle core pierces the sealing membrane to penetrate into the tube body, and the puncture hole pierced by the puncture needle core on the sealing membrane is closed under the self elasticity after the puncture needle core is withdrawn. The invention provides a puncture needle assembly and an ablation needle assembly, which can effectively prevent air from entering human tissues through a needle tube in the process of withdrawing a puncture needle core from the needle tube and after the withdrawal.

Description

Puncture needle assembly and ablation needle assembly

Technical Field

The invention relates to the technical field of medical instruments, in particular to a puncture needle assembly and an ablation needle assembly.

Background

The puncture needle is a minimally invasive surgical instrument which penetrates through skin and/or human muscle tissues to reach human organs to be treated, such as liver, kidney, lung, heart, thyroid, prostate and the like, and further establishes access to corresponding organs for other diagnosis and treatment instruments (such as biopsy needles, ablation needles and the like) in modern minimally invasive surgical treatment.

In the prior art, an ablation needle assembly is provided, wherein a puncture needle core and an ablation needle or a biopsy needle are alternately arranged in an outer sleeve in a penetrating way and are detachably connected with the outer sleeve, and the far end of the puncture needle core extends out of the outer sleeve; before ablation or biopsy, the puncture needle core and the outer sleeve are combined to puncture the tissue, then the connection between the puncture needle core and the outer sleeve is released, the puncture needle core is withdrawn, and an ablation needle or a biopsy needle penetrates into the outer sleeve to correspondingly perform ablation or biopsy operation. The puncture needle formed by combining the outer sleeve and the puncture needle core has the following defects: in the process of withdrawing the puncture needle core from the outer sleeve and after withdrawing, the air can be filled in the hollow outer sleeve, and in the process of inserting the follow-up biopsy needle or the ablation needle into the outer sleeve serving as a channel into a human body, a large amount of air in the outside and the outer sleeve can be squeezed into human tissues, a large amount of air bubbles can be gathered around the biopsy needle or the ablation needle point and are obviously shown under ultrasonic development, so that the judgment of a doctor in an operation is interfered, and the ablation treatment effect is seriously influenced.

Disclosure of Invention

The invention provides a puncture needle assembly and an ablation needle assembly which can effectively prevent air from entering human tissues through a needle tube in the process of withdrawing a puncture needle core from the needle tube and after the withdrawal.

The present invention provides a puncture needle assembly comprising:

the puncture needle tube comprises a hollow tube body and a tube seat fixedly connected with one end of the tube body, wherein the inner cavity of the tube seat is communicated with the inner cavity of the tube body;

the sealing element at least comprises an elastic sealing diaphragm, and the outer peripheral surface of the sealing diaphragm is attached to the inner wall of the inner cavity of the tube seat; and

the puncture needle core is detachably connected with the tube seat, the needle point of the puncture needle core pierces the sealing membrane to penetrate into the tube body, and the puncture hole pierced by the puncture needle core on the sealing membrane is closed under the self elasticity after the puncture needle core is withdrawn.

The ablation needle assembly provided by the invention comprises the puncture needle assembly and an ablation needle, wherein the outer surface of the tube body of the puncture needle tube is coated with an insulating layer, and the ablation needle is arranged in the puncture needle tube after the puncture needle core is withdrawn from the puncture needle tube.

The sealing piece is arranged in the tube seat of the puncture needle tube, and the peripheral surface of the sealing membrane is attached to the inner wall of the inner cavity of the tube seat, so that the sealing membrane in the sealing piece can be punctured to move towards the far end when the puncture needle core punctures. Because of the elasticity and the tension of the sealing diaphragm, the sealing diaphragm is tightly attached to and covers the outer wall of the puncture needle core in the puncturing process of the puncture needle core, and the outer peripheral surface of the sealing diaphragm is tightly attached to the inner wall of the inner cavity of the tube seat, so that the tube body of the puncture needle tube at the far end of the sealing diaphragm is isolated from the outside air, and the outside air is prevented from entering in the puncturing organization process. After the puncture needle core is pulled out, the puncture hole pierced by the puncture needle core of the sealing membrane can be automatically closed under the action of the elasticity and the tension of the sealing membrane, so that the air is prevented from entering the tube body after the puncture needle core is pulled out.

Moreover, in the process that other minimally invasive medical instruments such as an ablation needle or a biopsy needle penetrate into human tissues through the sealing membrane and the tube body again, the sealing membrane of the sealing element also isolates the air from the outside to achieve the purpose of sealing, so that the sealing of the whole operation process is ensured, and the air is prevented from entering the human tissues through the puncture needle tube.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in 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 it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

Figure 1 is an overall schematic view of a needle assembly in accordance with one embodiment of the present invention;

figure 2 is an exploded view of a needle assembly in accordance with one embodiment of the present invention;

FIG. 3 is a cross-sectional view taken along line A-A of one of the lancet assemblies provided in FIG. 1;

FIG. 4a is an isometric view of a tube seat body according to one embodiment of the present invention;

FIG. 4b is a cross-sectional view of a tube seat body according to an embodiment of the present invention;

FIG. 5a is an isometric view of a seal provided in accordance with an embodiment of the present invention;

FIG. 5b is a cross-sectional view of a seal according to one embodiment of the present invention;

FIG. 6a is an isometric view of a rear cap of a socket according to one embodiment of the present invention;

FIG. 6b is a cross-sectional view of a rear cap of a socket according to an embodiment of the present invention;

FIG. 7a is an isometric view of a mandrel holder according to an embodiment of the present invention;

FIG. 7b is a cross-sectional view of a hub in accordance with an embodiment of the present invention;

FIG. 8 is a schematic illustration of a needle assembly of the present invention during insertion;

FIG. 9 is a schematic view of a lancet core being withdrawn from a lancet tube according to an embodiment of the present invention;

FIG. 10 is a schematic view of the lancet core of the present invention after it has been withdrawn from the lancet tube;

FIG. 11 is a schematic view of the operation of an ablation needle in cooperation with a puncture needle cannula of an ablation needle assembly provided in accordance with an embodiment of the present invention;

FIG. 12 is a schematic view of the operation of a biopsy needle in cooperation with a puncture needle cannula of an ablation needle assembly provided in accordance with an embodiment of the present invention;

figure 13 is an overall schematic view of a needle assembly in accordance with a second embodiment of the present invention;

figure 14 is an exploded view of a spike assembly in accordance with a second embodiment of the present invention;

figure 15 is a cross-sectional view of the needle assembly of figure 13 taken along line B-B;

FIG. 16a is an isometric view of a socket according to a second embodiment of the present invention;

FIG. 16b is a cross-sectional view of a socket according to a second embodiment of the present invention;

fig. 17a is an isometric view of a first circlip provided in accordance with a second embodiment of the present invention;

fig. 17b is a cross-sectional view of a first circlip according to the second embodiment of the present invention;

fig. 18a is an isometric view of a second circlip provided in accordance with a second embodiment of the present invention;

fig. 18b is a cross-sectional view of a second circlip according to the second embodiment of the present invention;

FIG. 19a is an isometric view of a seal provided in accordance with a second embodiment of the present invention;

FIG. 19b is a cross-sectional view of a seal according to a second embodiment of the present invention;

figure 20 is an overall schematic view of a needle assembly in accordance with a third embodiment of the present invention;

figure 21 sets forth an exploded view of a needle assembly constructed in accordance with a third embodiment of the present invention;

figure 22 is a cross-sectional view of the needle assembly of figure 20 taken along line C-C;

FIG. 23a is a side view of a tube seat body according to a third embodiment of the present invention;

FIG. 23b is a cross-sectional view of a tube seat body according to a third embodiment of the present invention;

FIG. 24a is an isometric view of a seal provided in accordance with a third embodiment of the present invention;

FIG. 24b is a cross-sectional view of a seal according to a third embodiment of the present invention;

FIG. 25a is an isometric view of a rear cap of a socket according to a third embodiment of the present invention;

FIG. 25b is a cross-sectional view of a rear cap of a socket according to a third embodiment of the present invention;

figure 26 is a cross-sectional view of a needle assembly in accordance with a fourth embodiment of the present invention;

figure 27 sets forth a partially enlarged cross-sectional view of a needle assembly in accordance with a fourth embodiment of the present invention;

figure 28 is an exploded view of a needle assembly in accordance with a fourth embodiment of the present invention;

FIG. 29a is an isometric view of a cartridge body according to a fourth embodiment of the present invention;

fig. 29b is a cross-sectional view of a tube seat body according to a fourth embodiment of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. The embodiments of the present invention can be combined with each other as appropriate.

The invention provides a puncture needle assembly with a sealing function, which is used for isolating external air and preventing air from entering a human body through a puncture needle tube in the whole operation process.

In the embodiment of the invention, when an operator uses the puncture needle assembly to perform an operation, one end of the puncture needle assembly close to the operator is a proximal end, and one end of the puncture needle assembly far away from the operator is a distal end, which is not described in detail later.

The specific structure of the lancet assembly is illustrated in the following examples, but it is understood that the lancet assembly provided in the present invention includes, but is not limited to, the following embodiments.

The first embodiment is as follows:

referring to fig. 1 and 2, the lancet assembly 1 includes a lancet core 11, a lancet tube 12 and a sealing member 13.

Referring to fig. 2 and 3, the puncture needle tube 12 includes a hollow tube 121 and a tube holder 122. The stem 122 is fixedly attached to the proximal end of the tube body 121. The inner cavity of the tube holder 122 communicates with the inner cavity of the tube body 121.

Specifically, the tube body 121 and the tube seat 122 may be fixed together by gluing, integral injection molding, or the like. The tube 121 includes, but is not limited to, a metal material having excellent biocompatibility such as stainless steel.

Referring to fig. 2 and 3, the lancet 11 includes a lancet body 111 and a lancet holder 112 fixedly connected to a proximal end of the lancet body 111, and the lancet body 111 and the lancet holder 112 are connected together by gluing, integral injection molding or integral molding.

Referring to fig. 3, the puncture needle core body 111 is inserted into the tube 121. The core print 112 is detachably connected to the tube holder 122, so that when puncturing the human tissue, the core print 112 and the tube holder 122 can be easily connected together, and the puncture needle tube 12 and the puncture core 11 are synchronously pushed in. After the puncture is completed, the connection between the core print 112 and the tube seat 122 is conveniently released, so that the puncture needle tube 12 can be reserved as a passage for other medical instruments to enter human tissues, thereby reducing the puncture frequency and puncture injury.

The puncture needle core body 111 includes but is not limited to metal materials with high strength and toughness and excellent biocompatibility such as stainless steel. Optionally, the puncture needle core body 111 may be a solid body, and in order to ensure the sharpness of the puncture needle core body 111 during puncture, the tip of the distal end of the puncture needle core body 111 is in a sharp triangular pyramid shape or a needle point shape.

Referring to fig. 2, the sealing member 13 includes at least a sealing membrane 130 having elasticity. The outer peripheral surface of the sealing diaphragm 130 is fitted to the inner wall of the inner cavity of the stem 122. The material of the sealing membrane 130 includes, but is not limited to, rubber, plastic, and silicone with excellent elasticity. In this example, silica gel is used as an example for explanation.

The needle tip at the distal end of the lancet core 11 pierces the sealing membrane 130 to penetrate into the tube 121. The piercing hole of the sealing membrane 130 pierced by the puncture needle core 11 is closed by its own elastic force after the puncture needle core 11 is withdrawn.

By providing the seal 13 in the puncture needle tube 12 and fitting the outer peripheral surface of the seal membrane 130 to the inner wall of the inner cavity of the tube holder 122, the seal membrane 130 of the seal 13 is pierced and moved distally when the puncture needle core 11 is punctured. Due to the elasticity and tension of the sealing membrane 130, the sealing membrane 130 is tightly attached to and covers the outer wall of the puncture needle core 11 during the puncturing process of the puncture needle core 11, and the outer peripheral surface of the sealing membrane 130 is tightly attached to the inner wall of the inner cavity of the tube seat 122, so that the tube body 121 at the far end of the sealing membrane 130 is isolated from the outside air, and the outside air is prevented from entering during the puncturing process. After the puncture needle core 11 is pulled out, under the action of the elasticity and tension of the sealing membrane 130, the puncture hole of the sealing membrane 130 punctured by the puncture needle core 11 can be automatically closed, so that air is prevented from entering the tube body 121 after the puncture needle core 11 is pulled out.

Furthermore, in the subsequent process that other minimally invasive medical instruments such as an ablation needle or a biopsy needle puncture the sealing membrane 130 again and penetrate into the human tissue through the tube 121, the sealing membrane 130 of the sealing element 13 also isolates the air from the outside to achieve the sealing purpose, thereby ensuring the sealing of the whole operation process and preventing the air from entering the human tissue through the puncture needle tube 12.

Referring to fig. 3, the socket 122 includes a first limiting member 141 and a second limiting member 142. The first limiting member 141 and the second limiting member 142 respectively abut against two opposite sides of the sealing member 13 to fix the position of the sealing member 13, thereby ensuring the stability of the position of the sealing member 13 in the inner cavity of the tube seat 122.

Referring to fig. 2 and 3, the socket 122 includes a socket main body 1221 and a socket rear cover 1223. The pipe body 121, the stem body 1221, and the stem rear cover 1223 are connected in sequence and communicated with each other.

In the present embodiment, the first stopper 141 is a stem body 1221. The second limiting member 142 is a socket rear cover 1223.

For example, in fig. 4a and 4b, the end surface of the socket main body 1221 near the socket rear cover 1223 is provided with a mounting groove 143. The mounting groove 143 is formed by enlarging the inner cavity of the socket main body 1221. The sealing diaphragm 130 is disposed in the mounting groove 143, and the outer circumferential surface of the sealing diaphragm 140 is attached to the inner wall of the mounting groove 143. Referring to fig. 3, the distal end of the stem rear cover 1223 is disposed in the mounting groove 143 and abuts against the proximal end side of the sealing diaphragm 130.

Further, referring to fig. 3, 4a and 4b, the distal surface (bottom surface) of the mounting groove 143 is provided with a groove 12212. Referring to fig. 3, 5a and 5b, the main body of the sealing member 13 is a sealing membrane 130, and the sealing member 13 further includes a protrusion 12221 integrally interconnected with the sealing membrane 130. A projection 12221 is provided on the distal side of the sealing membrane 10. The shape of the recess 12212 is matched with the shape of the projection 12221, and the projection 12221 is engaged with the recess 12212 of the stem body 1221.

Referring to fig. 3, 5a and 5b, the protrusion 12221 is ring-shaped, and the cross-section of the protrusion 12221 is semicircular. The projection 12221 is close to or flush with the outer peripheral surface of the sealing diaphragm 130. In other words, the projection 12221 is provided on the edge of the distal end face of the sealing diaphragm 130. In other embodiments, the number of the projections 12221 may be plural and the plural projections 12221 are arranged in a ring shape.

Through setting up arch 12221 on sealing member 13 and being equipped with recess 12212 on the distal end face of mounting groove 143, these two kinds of structure mutual adaptation have played a spacing effect to sealing member 13, have guaranteed the stability of sealing member 13 at the inner chamber position of tube socket 122, prevent at the puncture in-process, because the resistance drive sealing member 13 of puncture needle core 11 and sealed diaphragm 130 moves to the distal end.

Referring to fig. 3, the tube seat rear cover 1223 is attached to the inner wall of the inner cavity of the mounting groove 143. In other embodiments, the stem rear cover 1223 is also connected to the outer peripheral surface of the stem main body 1221. Referring to fig. 6a and 6b, the distal end of the stem rear cap 1223 is a conical joint with external threads 12231. Specifically, referring to fig. 4b, the proximal end of the socket body 1221 is an external conical joint with a first internal thread 12211. Referring to fig. 3, the socket main body 1221 and the socket rear cap 1223 may be connected to each other by means of a thread fit of an inner and outer conical joint, and may be disassembled and connected by rotating the socket rear cap 1223. The connection mode of the inner cone joint and the outer cone joint ensures that the positioning effect and the concentricity are better ensured when the tube seat main body 1221 and the tube seat rear cover 1223 are assembled, and reduces the influence of the possible eccentricity problem between the tube seat main body 1221 and the tube seat rear cover 1223 on the assembly and the use. The inner thread and the outer thread are connected, so that the tube seat main body 1221 and the tube seat rear cover 1223 are convenient to connect and disassemble, and the connection is tight and reliable.

During assembly, the first internal thread 12211 (see fig. 4b) of the inner cavity of the tube holder main body 1221 and the external thread 12231 (see fig. 6b) of the rear cover are screwed together, so as to connect and fix the tube holder main body 1221 and the tube holder rear cover 1223, although the connection manner is not limited to threaded connection, and includes connection manners such as snap connection and glue adhesion. With the forward screwing of the socket rear cap 1223 in the threaded engagement, the sealing element 13 will be compressed and fixed, and this compression will ensure that the outer peripheral surface of the sealing element 13 can be tightly attached to the inner wall of the inner cavity of the socket 122, thereby effectively isolating air and preventing gas from entering from the gap between the outer peripheral surface of the sealing element 13 and the inner wall of the inner cavity of the socket 122.

Referring to fig. 2 and 3, the hub 112 is removably attached to the proximal end of the hub rear cover 1223.

For example, referring to fig. 6a and 6b, the outer circumference of the proximal end of the stem rear cover 1223 is provided with an external thread 12232, and the proximal end surface of the stem rear cover 1223 is provided with a receiving cavity 12233 communicated with the inner cavity of the stem rear cover 1223. The receiving chamber 12233 is formed by radially expanding an inner cavity of the stem rear cover 1223.

Referring to fig. 7a and 7b, a second internal thread 1121 and a tapered protruding column 1122 are disposed in the inner cavity of the needle core holder 112. Referring to FIG. 3, the proximal end of the plunger 11 is secured within the lumen of the tapered boss 1122. The tapered protruding column 1122 is disposed in the receiving cavity 12233 and contacts the inner wall of the receiving cavity 12233, so that the tapered protruding column 1122 is positioned in the socket rear cover 1223. The cavity of the tapered boss 1122 communicates with the cavity of the socket rear cap 1223. The needle core holder 112 and the rear cap 1223 of the tube holder can be connected to each other by positioning the tapered protruding column 1122 and the receiving cavity 12233 and by screwing the external thread 12232 and the second internal thread 1121, and can be detached and connected by rotating the needle core holder 112. The external thread 12232 is connected with the second internal thread 1121 in a thread fit manner, so that the stylet holder 112 and the tube holder rear cover 1223 are not only convenient to connect and disconnect, but also are tightly and reliably connected.

When this pjncture needle subassembly 1 is applied to and melts the operation, for the cooperation melts the needle execution and melts the operation, body 121 surface is scribbled and is attached the insulating layer to body 121 can regard as the insulation support that melts the needle, melts the part execution ablation that the needle stretches out body 121, and insulating layer material can be PTFE, PET, parylene, nylon, PVC etc. insulating material, preferentially select but not limited to the little and low PTFE insulating layer of coefficient of conductivity and coefficient of friction and parylene insulating layer, and the insulating layer wraps the surface at body 121 completely.

Referring to fig. 2, the exterior of the puncture needle tube 12 may be provided with scales 123 and number marks 124, the scales 123 are uniformly arranged, and the number marks 124 gradually increase from the distal end to the proximal end. When the lancet device 1 is inserted into the body tissue, the depth of the lancet core 11 into the body tissue can be determined by observing the outer scale 123 of the tube 121. Of course, the scale 123 mark at this time can also be marked by using scales 123 lines which are arranged non-uniformly and other ways.

Taking the application to the treatment of hypertrophic cardiomyopathy as an example, the puncture process of the puncture needle assembly 1 is as follows: referring to fig. 8, before puncturing, the puncture needle tube 12 and the puncture needle core 11 are connected, and at this time, the needle point of the puncture needle core 11 extends out of the distal end of the puncture needle tube 12, and when puncturing, one hand holds the puncture needle tube 12, the other hand holds the needle core holder 112, and applies a proper pushing force, so that the needle point of the puncture needle core 11 punctures the skin, penetrates the intercostal space and then punctures the cardiac apex to the myocardial hypertrophy position in the ventricular septum, and then the puncturing is completed. Referring to fig. 9, the puncture needle core 11 and the puncture needle tube 12 are separated, the puncture needle core 11 is slowly pulled out, and the sealing membrane 130 blocks air from entering the tube 121 and the human tissue. The schematic view after the puncture needle core 11 is withdrawn from the puncture needle tube 12 is shown in FIG. 10.

Referring to fig. 11, the ablation needle 15 then penetrates the channel created by the needle tube 12 and enters the hypertrophic myocardium to perform ablation. Referring to fig. 12, a biopsy needle 16 may be inserted into the hypertrophic myocardium to obtain a tissue sample before and/or after ablation. It can be seen that after the puncture needle assembly 1 is punctured once, the puncture needle tube 12 establishes a channel between the human tissue and the outside, and other medical instruments do not need to be punctured repeatedly when entering the human tissue, thereby reducing the puncturing frequency and reducing the puncturing damage, and no matter in the puncturing, melting or biopsy process, air cannot enter the tube body 121 of the puncture needle tube 12 and the inside of the human tissue due to the sealing effect of the sealing element 13, so that the ultrasonic development cannot be influenced, the doctor can observe and judge conveniently, and the ablation treatment effect is ensured.

Example two:

referring to fig. 13 and 14, a lancet assembly 2 with a sealing function according to a second embodiment of the present invention includes a lancet core 21, a lancet tube 22 and a sealing member 23.

Referring to fig. 14 and 15, the puncture needle tube 21 includes a hollow tube 221 and a tube holder 222 fixedly connected to one end of the tube 221. The lumen of the tube holder 222 communicates with the lumen of the tube body 221. Specifically, the tube body 221 and the tube seat 222 may be fixed together by gluing, integral injection molding, or the like. The tube 221 is made of, but not limited to, a metal material having excellent biocompatibility, such as stainless steel.

Referring to FIGS. 14 and 15, the lancet core 21 is removably connected to the hub 222. The needle tip of the puncture needle core 21 pierces the sealing membrane 230 to penetrate into the tube body 221. The piercing hole of the sealing membrane 230 pierced by the puncture needle core 21 is closed by its own elastic force after the puncture needle core 21 is withdrawn.

Referring to fig. 14 and 15, the lancet 21 includes a lancet body 211 and a lancet holder 212 fixedly connected to a proximal end of the lancet body 211, and the two are connected together by gluing, integral injection molding or integral molding.

Referring to fig. 15, the lancet body 211 is inserted into the tube 221. The hub 212 is detachably connected to the hub 222 so that when piercing tissue is desired, the hub 212 and the hub 222 are easily connected together and the piercing needle cannula 22 and the piercing needle hub 21 are advanced simultaneously. After the puncture is completed, the connection between the core barrel seat 212 and the tube seat 222 is conveniently released, so that the puncture needle tube 22 can be reserved as a passage for other medical instruments to enter human tissues, the puncture frequency is reduced, and the puncture injury is reduced.

The lancet core 211 includes but is not limited to stainless steel and other metal materials with high strength and toughness and excellent biocompatibility. Optionally, the puncture needle core body 211 may be a solid body, and in order to ensure the sharpness of the puncture needle core body during puncture, the distal end of the puncture needle core 21 is in a sharp triangular pyramid shape or a needle point shape.

Referring to fig. 14 and 15, the sealing member 23 includes a sealing membrane 230 having elasticity. The outer peripheral surface of the sealing diaphragm 230 is fitted to the inner wall of the inner cavity of the stem 222. The material of the sealing membrane 230 includes, but is not limited to, rubber, plastic, and silicon rubber with excellent elasticity. In this example, silica gel is used as an example for explanation.

By providing the sealing member 23 in the puncture needle tube 22 and fitting the outer peripheral surface of the sealing membrane 230 to the inner wall of the inner cavity of the tube holder 222, the sealing membrane 230 of the sealing member 23 is broken and moved distally when the puncture needle core 21 punctures. Because of the elasticity and tension of the silica gel material of the sealing membrane 230, the sealing membrane 230 will tightly attach to and cover the outer wall of the puncture needle core 21 during the puncturing process of the puncture needle core 21, and because the outer peripheral surface of the sealing membrane 230 is tightly attached to the inner wall of the inner cavity of the tube seat 222, the tube body 221 at the distal end of the sealing membrane 230 will be isolated from the outside air, thereby preventing the outside air from entering during the puncturing process. After the puncture needle core 21 is pulled out, under the action of the elasticity and the tension of the silica gel material of the sealing membrane 230, the puncture hole pierced by the puncture needle core 21 of the sealing membrane 230 can be automatically closed, so that the air is prevented from entering the tube body 221 after the puncture needle core 21 is pulled out.

Furthermore, in the subsequent process that other minimally invasive medical instruments such as an ablation needle or a biopsy needle are inserted into the human tissue through the sealing membrane 230 and the tube body 221 again, the sealing membrane 230 of the sealing element 23 also isolates the air from the outside to achieve the sealing purpose, so that the sealing in the whole operation process is ensured, and the air is prevented from entering the human tissue.

Referring to fig. 14 and 15, the tube seat 222 includes a first elastic collar 231 and a second elastic collar 233 abutting against opposite sides of the sealing element 23, respectively, and the first elastic collar 231 and the second elastic collar 233 are used for fixing the position of the sealing element 23. In other words, the first and second

elastic collars

231 and 233 may serve as first and second stoppers on opposite sides of the seal 23.

Referring to fig. 14 and 15, the first elastic collar 231 and the second elastic collar 233 are both disposed on the inner wall of the inner cavity of the tube seat 222. The first elastic collar 231 and the second elastic collar 233 abut against two opposite sides of the sealing member 23 respectively to fix the position of the sealing member 23, and the stability of the position of the sealing member 23 in the inner cavity of the tube seat 222 is ensured.

Referring to fig. 15, the outer circumferential surfaces of the first and second

elastic stoppers

231 and 233 are sealingly connected to the inner wall of the inner cavity of the stem 222.

Referring to fig. 15, 16a and 16b, the inner diameter of the lumen of the hub 222 increases from the distal end to the proximal end. The outer peripheral surfaces of the first circlip 231, the seal 23, and the second circlip 233 all have a conical surface. The outer peripheral surfaces of the first circlip 231, the seal 23, and the second circlip 233 are all attached to the inner wall of the inner cavity of the stem 222.

Referring to fig. 17a, 17b, 18a and 18b, the first circlip 231 and the second circlip 233 are both provided with axial through holes. The axial through holes of the first circlip 231 and the second circlip 233 have a diameter smaller than, larger than, or equal to the diameter of the puncture needle core 21.

Referring to fig. 15, 19a and 19b, the sealing member 23 further includes an annular abutting portion 2323 integrally formed with the sealing diaphragm 230. The sealing diaphragm 230 abuts against the first elastic collar 231. The annular abutment 2323 abuts against the second circlip 233. The annular abutment 2323 has a through-hole aperture that is greater than or equal to the diameter of the lancet core 21.

During assembly, the first circlip 231, the sealing member 23 and the second circlip 233 are tightly fitted into the conical inner cavity 2221 (see fig. 16b) of the socket 222 in the order of assembly, and the assembly is as shown in fig. 15. Referring to fig. 15, in the direction along the axis of the inner cavity of the socket 222, the first elastic collar 231, the sealing member 23 and the second elastic collar 233 are tightly attached without a gap or substantially without a gap, and the outer walls of the three are tightly attached to the inner wall of the conical inner cavity 2221 of the socket 222. The first circlip 231 is fixed to the inner wall of the conical cavity 2221 of the socket 222 by means of glue bonding or conical self-positioning.

Referring to fig. 17a and 17b, the outer wall 2311 of the first circlip 231 is tapered, and the taper of the outer wall is the same as the taper of the inner wall of the inner cavity 2221 (fig. 16b) of the tube seat 222, so as to ensure that the inner and outer conical surfaces can be fitted tightly under the action of the taper to reduce the gap. The first circlip 231 serves to limit the axial distal movement of the sealing element 23. Through setting up first circlip 231, and first circlip 231 is fixed in the tube socket 222, can solve effectively that the puncture needle core 21 drives sealing member 23 and breaks away from original position and deformation scheduling problem along the inner chamber axial towards distal end extrusion and sealing member 23 that leads to at the in-process that passes sealing member 23, frictional force when reducing puncture needle core 21 puncture sealing member 23.

Referring to fig. 19a and 19b, the sealing member may be made of medical silica gel, which has flexibility and elasticity. The outer peripheral surface 2321 of the sealing member 23 is adhered to the inner wall of the inner cavity of the tube seat 222 by glue, so as to ensure that the outer peripheral surface 2321 of the sealing member 23 can be tightly attached to the inner wall of the conical inner cavity of the tube seat 222, the outer peripheral surface 2321 of the sealing member 23 is conical, and the taper of the outer peripheral surface 2321 of the sealing member 23 is consistent with the taper of the inner wall of the conical inner cavity 2221 of the tube seat 222. The annular abutting portion 2323 and the sealing diaphragm 230 surround an inner cavity 2322 forming the sealing member 23, the inner cavity 2322 of the sealing member 23 is a conical inner cavity which is not completely penetrated in the axial direction of the sealing member 23, and the distal end of the inner cavity 2322 of the sealing member 23 is the sealing diaphragm 230 which is integrated with the conical inner cavity and has a certain thickness.

Referring to fig. 18a and 18b, in order to fit tightly and reduce the gap, the outer wall 2332 of the second circlip 233 is also conical in shape, and the taper is also consistent with the taper of the inner wall of the cavity 2221 of the socket 222. The outer wall 2332 of the second circlip 233 is connected to the inner wall of the inner cavity 2221 of the tube holder 222 by means of glue. However, due to the matching between the two tapered surfaces, if glue is directly applied to the outer surface of the second circlip 233, the glue will inevitably be extruded out and attached to the inner wall of the tube seat 222, and the glue will be extruded out of the joint surface of the second circlip, which will result in insufficient glue on the contact surface and affect the bonding performance, therefore, a circle of grooves 2333 is formed in the outer wall 2332 of the second circlip 233, and the grooves 2333 are used for accommodating the glue, so that the glue cannot be extruded out of the joint surface, and the bonding firmness is ensured.

It is understood that a ring of grooves may be formed on the outer circumferential surface of the first circlip 231, and the specific structure may refer to the groove 2333 of the second circlip 233, which is not described herein again.

Referring to fig. 15, the needle assembly 2 also includes a hub mount 212 fixedly attached to the proximal end of the plunger 21. The hub 212 is removably attached to the proximal end of the hub 222.

The structure of the core print 212 in this embodiment is the same as the structure of the core print 112 in the first embodiment, and the description thereof is omitted.

Referring to FIG. 15, the proximal end of the hub 222 is removably connected to the hub 212 by a threaded connection, a snap-fit connection, or the like.

The process of piercing and withdrawing the sealing membrane 230 by the lancet 21 is the same as the process of piercing and withdrawing the sealing membrane 130 by the lancet 11 in the first embodiment, and will not be described again.

Example three:

referring to fig. 20, the lancet assembly 3 includes a lancet core 31 and a lancet tube 32.

Referring to fig. 21 and 22, the puncture needle tube 32 includes a hollow tube 321 and a tube holder 322 fixedly connected to one end of the tube 321. The inner cavity of the tube holder 322 communicates with the inner cavity of the tube body 321. Specifically, the tube 321 and the tube seat 322 may be fixed together by gluing, integral injection molding, or the like. The tube 321 includes, but is not limited to, a metal material with excellent biocompatibility such as stainless steel.

Referring to fig. 21 and 22, the sealing member 33 includes a sealing diaphragm 330 having elasticity. The outer peripheral surface of the sealing diaphragm 330 is fitted to the inner wall of the inner cavity of the stem 322. The puncture needle core 31 is detachably connected to the hub 322. The needle tip of the puncture needle core 31 pierces the sealing membrane 330 to penetrate into the tube 321. The piercing hole of the sealing membrane 330 pierced by the lancet 31 is closed by its own elastic force after the lancet 31 is withdrawn.

Referring to fig. 22, the socket 322 includes a first position-limiting member 341 and a second position-limiting member 342. The first limiting member 341 and the second limiting member 342 respectively abut against two opposite sides of the sealing member 33 to fix the position of the sealing member 33.

Referring to fig. 21 and 22, the socket 322 includes a socket main body 3221 and a socket rear cover 3223. The tube 321, the tube base main body 3221, and the tube base rear cover 3223 are connected in series and communicate with each other. The first stopper 341 is a stem main body 3221. The second limiting member 342 is a stem rear cover 3223.

Specifically, referring to fig. 23a and 23b, an installation groove 32210 is disposed on the proximal end of the tube seat main body 3221. The mounting groove 32210 is formed by an enlargement of the inner cavity of the stem body 3221. Referring to fig. 22, the outer circumferential surface of the sealing diaphragm 330 is attached to the inner wall of the mounting groove 32210.

Referring to fig. 24a and 24b, the sealing member 33 has a substantially cylindrical shape. The outer cylindrical surface 32221 (see FIG. 24a) is in close contact with the cylindrical interior 32212 (see FIG. 23b) of the header body 3221.

Referring to fig. 24a and 24b, the sealing member 33 further includes a sealing post 331 integrally formed with the sealing diaphragm 330. The sealing post 331 has a first through hole 32224 and a second through hole 32222 communicating with each other. The diameter of the second aperture 32222 is less than or equal to the diameter of the lancet core 31. The first through hole 32224 has a diameter larger than the diameter of the lancet core 31. The sealing diaphragm 330 is sealed at the opening of the first through hole 32224 on the side away from the second through hole 32222.

Referring to FIG. 23b, a conical interior 32211 is provided within the main body 3221 of the stem. A conical lumen 32211 is provided at the distal end of the sealing diaphragm 330. The conical cavity 32211 is used to guide the lancet 31 during puncturing the tubular body 321 of the lancet tube 32, thereby avoiding the problem of the lancet 31 getting caught on the step during puncturing.

Referring to fig. 23b and fig. 24b, the sealing member 33 may be made of medical grade silicone. The diameter of the outer cylindrical surface 32221 of the sealing member 33 is slightly larger than the diameter of the cylindrical cavity 32212 of the tube seat 3221, so that the wall of the cylindrical cavity of the sealing member 33 after being installed in the cylindrical cavity 32212 of the tube seat 3221 can press the sealing member 33, so that the sealing member 33 and the sealing member are tightly matched, and the possibility of air entering the interior of the puncture needle tube 32 through the gap between the sealing member and the sealing member is reduced.

Referring to FIG. 24b, the second aperture 32222 is a cylindrical interior space within the sealing member 33, and the diameter of the second aperture 32222 is slightly smaller than the diameter of the lancet core 31. When the lancet core 31 penetrates the sealing diaphragm 330 inwardly through the second through hole 32222, the sealing member 33 will be pressed by the outer wall of the lancet core 31 due to the diameter of the lancet core 31 being larger than the diameter of the second through hole 32222, so that the sealing member 33 can be tightly attached to the outer wall of the lancet core 31, thereby ensuring that air cannot enter. The distal end of the second through hole 32222 communicates with a first through hole 32224 having an increasing radial dimension, and the radial dimension of the first through hole 32224 gradually increases from the proximal end to the distal end. The distal end of the first through hole 32224 is integrally connected to the sealing diaphragm 330, and the sealing diaphragm 330 and the second through hole 32222 cooperate to perform a double sealing function. The arrangement of the first through hole 32224, on one hand, reduces the length of the second through hole 32222 tightly wrapping the puncture needle core 31, thereby reducing the puncture resistance; on the other hand, the sealing membrane 330 is prevented from being too thick, so that the puncture resistance can be reduced; in another aspect, the first through hole 32224 can also accommodate air squeezed therein, reducing the pressure, and preventing the air therein from pressing open the puncture hole of the sealing membrane 330 punctured by the puncture needle core 31.

Referring to fig. 22, 24a and 24b, a flange 32223 is disposed at a proximal end of an outer circumferential surface of the sealing post 331. The flange 32223 is disposed outside the mounting groove 32210. The flange 32223 is sandwiched between the proximal end surface of the stem body 3221 and the stem rear cover 3223. When the hub rear cover 3223 is secured to the proximal end of the hub main body 3221, the proximal end surface of the hub main body 3221 and the hub rear cover 3223 may secure the sealing member 33 such that the sealing diaphragm 330 is secured within the interior cavity of the hub main body 3221 and the position of the sealing diaphragm 330 does not move with the lancing process of the lancet core 31.

In this embodiment, referring to fig. 22, the proximal end of the main body 3221 of the stem is snap-fit connected to the distal end of the rear cover 3223 of the stem. Referring to fig. 23a, the proximal end of the main body 3221 has a slot 32213 on its outer circumference. Referring to fig. 25a and 25b, a latch 32231 matching with the locking groove 32213 is disposed on an inner wall of the distal end of the inner cavity of the rear cover 3223 of the tube seat. The main body 3221 and the rear cover 3223 are connected by a snap 32213 (see fig. 23a) on the main body 3221 and a snap 32231 (see fig. 25b) on the rear cover 3223.

Referring to FIGS. 24a and 24b, the sealing element 33 is provided with a flange 32223 at a proximal end thereof, and the flange 32223 is tightly pressed between the main body 3221 of the stem and the rear cover 3223 of the stem, thereby fixing the sealing element 33. Of course, the connection between the main body 3221 and the rear cover 3223 is not limited to the snap connection, but also includes an adhesive connection, a screw connection, and the like. Compared with the second embodiment, the connection mode does not need to additionally arrange a structure for limiting the sealing element 33 in the inner cavity of the tube holder main body 3221, so that the number of parts of the puncture needle assembly 3 is reduced, and compared with a fixing mode which needs to be bonded by glue, the flange 32223 of the sealing element 33 is clamped between the proximal end of the tube holder main body 3221 and the distal end of the tube holder rear cover 3223, so that the assembly is quicker and more convenient.

Referring to fig. 24a, a support rib 32225 is disposed outside the second through hole 32222 to increase the structural strength of the sealing member 23. Compared with the first embodiment in which the sealing member 33 only relies on the sealing membrane 330 to isolate air, the sealing member 33 in this embodiment adopts the second through hole 32222 and the sealing membrane 330 to perform double sealing, and particularly, during the process that the needle tip of the lancet 31 is just withdrawn from the puncture hole and the sealing membrane 330 is restored to be closed under the action of elasticity and tension of the material, the inner wall of the second through hole 32222 holds the peripheral wall of the lancet 31, so as to prevent air from entering the tube body 321 and the human tissue in the short period of time, and the sealing effect is more remarkably reliable. The process of piercing and withdrawing the sealing membrane 330 by the lancet 31 is the same as that of the previous embodiment, and will not be repeated here.

Referring to fig. 22, the needle assembly 3 further includes a hub mount 312 fixedly attached to the proximal end of the hub body 311. The hub 312 is removably attached to the proximal end of the hub 322. The proximal end of the hub rear cover 3223 may be snap-fit or threaded with the hub 312. reference may be made to the connection of the hub rear cover with the hub in the first embodiment, and no further description is provided herein.

Example four:

referring to figure 26, a fourth embodiment of a needle assembly 4 is provided. With respect to any of the embodiments one through three, the needle assembly of this embodiment further includes a suction device 43 for drawing air from the interior of the needle assembly 4. In this embodiment, the puncture needle assembly provided in the third embodiment is exemplified by adding the air extracting device 43, so that the structures of the puncture needle core 41, the puncture needle tube 42, the tube body 421 of the puncture needle tube, the tube seat 422, the needle core main body 411, the needle core seat 412, the tube seat main body 4221, the tube seat rear cover 4223, and the sealing element 44 in the puncture needle assembly 4 of the fourth embodiment can refer to the corresponding structures in the third embodiment, and are not described herein again, and the present embodiment mainly describes differences from the third embodiment. Of course, the puncture needle assembly 4 provided in this embodiment may further include an air-extracting device 43 in addition to the puncture needle assemblies provided in the first and second embodiments.

Referring to fig. 26 to 28, the stem main body 4221 further includes an evacuation outlet 42211. The inner cavity of the exhaust gas outlet 42211 communicates with the inner cavity of the tube seat 422 and the inner cavity of the tube 421. The air extractor 43 communicates with the extracted air outlet 42211. The evacuation exit 42211 is located at the distal end of the sealing element 44, and one end of the evacuation exit 42211 communicates with the inner cavity of the tube seat 422, and the other end is a tower-shaped barbed head 42212 (see fig. 29a and 29 b).

Referring to fig. 26 to 28, the air extractor 43 includes a pipe 430 hermetically connected to the air extraction outlet 42211 and an air extractor 434 hermetically connected to the pipe 430.

Referring to fig. 26 to 28, the pipeline 430 includes a first hose 431, a one-way valve 432 and a second hose 433. Both ends of the one-way valve 432 are tower-shaped barb heads, and the diameter of the one-way valve is slightly larger than the inner diameter of the hose. The one-way valve 432 ensures that air can only flow from the inside to the outside of the socket 422 and not back into the socket. The first hose 431 is sleeved at one end to the tower-shaped barb 42212 of the exhaust outlet 42211 and bonded by glue, and sleeved at the other end to the tower-shaped barb at one end of the check valve 432 and bonded by glue. One end of the second hose 433 is sleeved to the tower-shaped barb head at the other end of the one-way valve 432 and connected with the same through glue. The distal end of the air pumping member 434 is sleeved with the other end of the second hose 433 and bonded thereto by glue. The pumping element 434, which includes but is not limited to a syringe, pump, etc., is intended to draw air from within the spike assembly 4.

The fourth embodiment adds an air extractor 43 to the first through third embodiments to not only isolate the air from the proximal side of the seal 44 in the needle assembly 4 by the seal 44 to prevent outside air from entering the distal side of the seal 44 in the needle assembly 4, but also to extract air present inside the needle assembly 4 by the air extractor 43. The air inside the puncture needle assembly 4 can be extracted by operating the air extractor 43 after the puncture needle core 41 and the puncture needle tube 42 are connected and assembled each time and before puncturing the human tissue, thereby further reducing the possibility of air entering the human tissue.

Example five:

referring to fig. 11 in combination, the embodiment of the present invention further provides an ablation needle assembly 5, including the puncture needle assembly and the ablation needle 15 of any of the above embodiments. The puncture needle assembly 1 of the first embodiment will be described as an example. The ablation needle 15 and the puncture needle core 11 can be alternately arranged in the puncture needle tube 12. In other words, the ablation needle 15 is inserted into the puncture needle tube 12 after the puncture needle core 12 is withdrawn from the puncture needle tube 12.

The outer surface of the tubular body 121 of the puncture needle tube 12 is coated with an insulating layer so that the tubular body 121 can serve as an insulating sleeve for the ablation needle 15, and ablation is performed on the portion of the ablation needle 15 extending out of the tubular body 121. The insulating layer material can be PTFE, PET, parylene, nylon, PVC, or other insulating materials, but not limited to a PTFE insulating layer and a parylene insulating layer with a small conductivity coefficient and a low friction coefficient can be selected, and the insulating layer completely covers the outer surface of the tube body 121.

Referring to fig. 12, ablation needle assembly 5 further includes biopsy needle 16. The biopsy needle 16 and the ablation needle 15 are alternately inserted into the puncture needle tube 12.

Taking the application to the treatment of hypertrophic cardiomyopathy as an example, the working process of the ablation needle assembly 5 is as follows: referring to fig. 8, before puncturing, the puncture needle tube 12 and the puncture needle core 11 are connected, and at this time, the needle point of the puncture needle core 11 extends out of the distal end of the puncture needle tube 12, and when puncturing, one hand holds the puncture needle tube 12, the other hand holds the puncture needle core seat 121, and applies a proper pushing force, so that the needle point of the puncture needle core 11 punctures the skin, penetrates the intercostal space, then punctures the heart point, and reaches the myocardial hypertrophy position in the ventricular septum, and then the puncturing is completed.

Referring to fig. 9, the puncture needle core 11 and the puncture needle tube 12 are separated, the puncture needle core 11 is slowly pulled out, and the sealing membrane 130 (see fig. 2) blocks air from entering the tube 121 and the human tissue. The puncture needle cartridge 11 is shown in fig. 10 after being separated from the puncture needle tube 12.

Referring collectively to fig. 11, the ablation needle 15 performs ablation by puncturing the passageway created by the needle cannula 12 into the hypertrophic myocardium.

Referring to fig. 12 in conjunction, before and/or after ablation, a biopsy needle 16 may also be used to access the passageway established by the needle cannula 12 to access the hypertrophic myocardium to obtain a tissue sample. It can be seen that after one-time puncture by the puncture needle core 11, the puncture needle tube 12 establishes a channel between the human tissue and the outside, so that repeated puncture is not needed when other medical instruments enter the human tissue, thereby reducing the number of times of puncture, and reducing puncture damage, and no matter in the process of puncture, ablation or biopsy, air cannot enter the tube body 121 of the puncture needle tube and the inside of the human tissue due to the sealing effect of the sealing element 13 (please refer to fig. 2), thereby not affecting ultrasonic development, facilitating observation and judgment of doctors, and ensuring ablation treatment effect.

While the foregoing is directed to embodiments of the present invention, it will be appreciated by those skilled in the art that various changes and modifications may be made without departing from the principles of the invention, and it is intended that all such changes and modifications be considered as within the scope of the invention.

Claims

1. A needle assembly, comprising:

2. The needle assembly of claim 1, wherein the hub includes a first retaining member and a second retaining member, the first retaining member and the second retaining member abutting opposite sides of the seal to fix the position of the seal.

3. The needle assembly of claim 2 wherein said hub includes a hub body and a hub back cover, said hub body and said hub back cover being connected in series and in communication with each other, said first stop being said hub body and said second stop being said hub back cover.

4. The puncture needle assembly of claim 3, wherein the end surface of the holder main body adjacent to the rear cover of the holder is provided with a mounting groove, the mounting groove is formed by expanding the inner cavity of the holder main body, and the outer peripheral surface of the sealing membrane is fitted to the inner wall of the mounting groove.

5. The lancet assembly of claim 4, wherein the distal surface of the mounting groove defines a recess, and wherein the seal further comprises a projection integrally interconnected with the sealing membrane, the projection being engaged within the recess of the cartridge body.

6. The lancet assembly of claim 5, wherein the protrusion is annular, or wherein there are a plurality of protrusions arranged in an annular array, the protrusions being adjacent to or flush with the periphery of the sealing membrane.

7. The puncture needle assembly of claim 4, wherein the distal end of the hub rear cover is disposed in the mounting groove and abuts against the sealing diaphragm, and the hub rear cover is attached to an inner wall of an inner cavity of the mounting groove or to an outer peripheral surface of the hub main body.

8. The lancet assembly of claim 4, wherein the sealing member further comprises a sealing post integrally formed with the sealing membrane, the sealing post having a first through hole and a second through hole in communication, the second through hole having a diameter less than or equal to the diameter of the lancet core, the first through hole having a diameter greater than the diameter of the lancet core, the sealing membrane sealing the opening of the first through hole.

9. The puncture needle assembly according to claim 8, wherein a flange is provided on a proximal end of an outer peripheral surface of the sealing post, the flange is provided outside the mounting groove, and the flange is interposed between a proximal end surface of the hub main body and the hub rear cover.

10. The needle assembly of claim 2, wherein the first retaining member and the second retaining member are disposed on an interior wall of the interior chamber of the hub.

11. The needle assembly of claim 10 wherein the first retaining member comprises a first circlip and the second retaining member comprises a second circlip, an outer circumferential surface of the first circlip and an outer circumferential surface of the second circlip being sealingly attached to an inner wall of the interior chamber of the hub.

12. The needle assembly of claim 11, wherein the inner diameter of the interior chamber of the hub increases gradually from distal to proximal, the outer circumferential surfaces of the first circlip, the seal, and the second circlip are all conical, and the outer circumferential surfaces of the first circlip, the seal, and the second circlip are all attached to the inner wall of the interior chamber of the hub.

13. The needle assembly of claim 11 wherein said first circlip and said second circlip each define an axial through hole, each of said axial through holes having a diameter less than, greater than, or equal to the diameter of said lancet core.

14. The needle assembly of claim 10 wherein said seal further comprises an annular abutment integrally formed with said sealing diaphragm, said sealing diaphragm abutting said first stop and said annular abutment abutting said second stop, said annular abutment having a bore diameter greater than or equal to the diameter of said lancet core.

15. The lancet assembly of any one of claims 1 to 14, further comprising a hub holder fixedly attached to the proximal end of the lancet, wherein the hub holder is removably attached to the proximal end of the hub.

16. The puncture needle assembly according to any one of claims 1 to 14, further comprising an air-extracting device, wherein the tube holder is further provided with an air-extracting lead-out portion, an inner cavity of the air-extracting lead-out portion communicates with an inner cavity of the tube holder and an inner cavity of the tube body, and the air-extracting device communicates with the air-extracting lead-out portion.

17. The puncture needle assembly of claim 16, wherein said suction device comprises a conduit sealingly connected to said suction lead and a suction member sealingly connected to said conduit.

18. The needle assembly of claim 17 wherein a one-way valve is disposed on said conduit.

19. An ablation needle assembly comprising the puncture needle assembly according to any one of claims 1 to 18 and an ablation needle, wherein an outer surface of a tubular body of the puncture needle tube is coated with an insulating layer, and the ablation needle is inserted into the puncture needle tube after the puncture needle core is withdrawn from the puncture needle tube.

20. The ablation needle assembly of claim 19, further comprising a biopsy needle that is alternately threaded into the puncture needle cannula with the ablation needle.