CN114642481A

CN114642481A - Bendable puncture needle and puncture system

Info

Publication number: CN114642481A
Application number: CN202011501586.1A
Authority: CN
Inventors: 高国庆; 王丹; 王永胜
Original assignee: Hangzhou Nuosheng Medical Technology Co ltd
Current assignee: Hangzhou Nuosheng Medical Technology Co ltd
Priority date: 2020-12-18
Filing date: 2020-12-18
Publication date: 2022-06-21
Also published as: WO2022127905A1

Abstract

The invention discloses an adjustable puncture needle and a puncture system. The bendable puncture needle includes a puncture head and a bendable cannula assembly sleeved with the puncture head; the puncture head is used to puncture the tissue body; the distal end of the bendable cannula assembly is provided with a bendable section, and the puncture head is provided with a bendable section. The distal end is exposed outside the adjustable bendable segment, and the proximal end of the puncture head is fixed on the distal end of the adjustable bendable segment; the bendable sleeve assembly includes a multi-layered tube body with bendable function, and the bendable puncture needle also It includes a traction member arranged between multiple layers of tubular bodies with adjustable bending function, and the distal end of the traction member is fixed on the puncture head or the adjustable bending section, because the adjustable puncture needle can be driven by the traction member after entering the patient's body. The puncture head and the bendable cannula assembly can adjust the direction freely, so the puncture head can be more accurately aligned with the target tissue to be punctured, thereby avoiding damage to the passage of the internal puncture operation caused by the bendable puncture, and making the puncture more accurate and fast.

Description

Bendable puncture needle and puncture system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a bending-adjustable puncture needle and a puncture system.

Background

With the rapid development of interventional instruments and equipment, the application of cardiac interventional therapy is more and more extensive, so that atrial septal puncture is more and more widely applied. In the interatrial puncture procedure, a catheter is generally used as an auxiliary instrument for an interventional procedure to puncture the interatrial septum. However, in the interatrial puncture operation, the puncture position needs to be precisely controlled to avoid the problem that the surrounding tissues are accidentally punctured to damage the heart.

However, the existing puncture needle cannot be bent, so that tissues are easily scratched in a puncture operation, and the puncture is not accurate enough and time-consuming.

Disclosure of Invention

In view of the above, the present invention provides an adjustable bending puncture needle and puncture system to solve the above problems.

In a first aspect, an embodiment of the present invention provides an adjustable bending puncture needle, including a puncture head and an adjustable bending sleeve assembly sleeved on the puncture head; the puncture head is used for puncturing a tissue body; the far end of the adjustable bent sleeve assembly is provided with an adjustable bent section, the far end of the puncture head is exposed out of the adjustable bent section, and the near end of the puncture head is fixed on the far end of the adjustable bent section; the adjustable bending sleeve assembly comprises a plurality of layers of pipe bodies with adjustable bending functions, the adjustable bending puncture needle further comprises a traction assembly arranged between the plurality of layers of pipe bodies with adjustable bending functions, and the far end of the traction assembly is fixed on the puncture head or the adjustable bending section.

In a second aspect, an embodiment of the present invention provides a flexible device, including a control handle and the above-mentioned adjustable bending puncture needle, wherein a distal end of the control handle is fixedly connected to a proximal end of the adjustable bending puncture needle, the proximal end of the control handle is externally connected to an energy generator and a liquid supply pipeline having a valve, the energy generator is used for being connected to the puncture head to provide an ablation energy source, and the liquid supply pipeline is used for conveying a fluid.

According to the adjustable bent puncture needle and puncture system provided by the embodiment of the invention, the traction component is arranged in the adjustable bent sleeve component, and the distal end of the traction component is fixed on the puncture head or the adjustable bent section of the adjustable bent sleeve component, so that the direction of the adjustable bent puncture needle can be freely adjusted by driving the puncture head and the adjustable bent sleeve component through the traction component after the adjustable bent puncture needle enters a patient body, the puncture head can be more accurately aligned with a target tissue to be punctured, further, the adjustable bent puncture needle is prevented from damaging a path of an in-vivo puncture operation, and the puncture is more accurate and rapid.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art 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 for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.

Fig. 1 is a schematic structural view of a puncture system according to a first embodiment of the present invention.

Fig. 2 is a schematic view of the structure of portion a of the adjustable bend spike of the lancing system of fig. 1.

Fig. 3 is a cross-sectional view of the adjustable bend spike of the spike system of fig. 2 taken along line III-III.

Fig. 4 is a cross-sectional view of the first embodiment of the piercing head and adjustable bent cannula assembly of the adjustable bent puncture needle of fig. 2 taken along a radial direction of the adjustable bent puncture needle.

Fig. 5 is a cross-sectional view of a second embodiment of the piercing head and adjustable bent cannula assembly of the adjustable bent introducer needle of fig. 2, taken along a radial direction of the adjustable bent introducer needle.

Fig. 6 is a cross-sectional view of a third embodiment of the piercing head and adjustable bent cannula assembly of the adjustable bent introducer needle of fig. 2, taken along a radial direction of the adjustable bent introducer needle.

Fig. 7 is a cross-sectional view of a fourth embodiment of the piercing head and adjustable bent cannula assembly of the adjustable bent introducer needle of fig. 2, taken along a radial direction of the adjustable bent introducer needle.

Fig. 8 is an exploded view of a portion of the puncture system of fig. 1.

Fig. 9 is a sectional view of a part of the puncture system in fig. 1.

Fig. 10 is an exploded view of a partial structure of a puncture system according to a second embodiment of the present invention.

Fig. 11 is a cross-sectional view of a first embodiment of the piercing head and adjustable bent cannula assembly of the adjustable bent piercing needle of the piercing system of fig. 10 along an axial direction of the adjustable bent piercing needle.

Fig. 12 is a cross-sectional view of a second embodiment of the piercing head and adjustable bent cannula assembly of the adjustable bent piercing needle of the piercing system of fig. 10, taken along the axial direction of the adjustable bent piercing needle.

Fig. 13 is a cross-sectional view of a third embodiment of the piercing head and adjustable bent cannula assembly of the adjustable bent piercing needle of the piercing system of fig. 10, taken along the axial direction of the adjustable bent piercing needle.

Fig. 14 is a cross-sectional view of the first embodiment of the piercing head and adjustable bent cannula assembly of the adjustable bent introducer needle of fig. 11 taken along a radial direction of the adjustable bent introducer needle.

Fig. 15 is a cross-sectional view of a second embodiment of the piercing head and adjustable bent cannula assembly of the adjustable bent introducer needle of fig. 11, taken along a radial direction of the adjustable bent introducer needle.

Fig. 16 is a cross-sectional view of a third embodiment of the piercing head and adjustable bent cannula assembly of the adjustable bent introducer needle of fig. 11, taken along a radial direction of the adjustable bent introducer needle.

Fig. 17 is a cross-sectional view of a fourth embodiment of the piercing head and adjustable bent cannula assembly of the adjustable bent introducer needle of fig. 11, taken along a radial direction of the adjustable bent introducer needle.

Fig. 18 is a sectional view of a part of the structure of the puncture system in fig. 10.

Description of the main elements

Puncture system 1000

Adjustable bend puncture needle 100

Puncture head 10

Fluid channel 101

Water outlet 103

Flexible tip 11

Cavity 12

Electrical guide wire 14

Outer axial surface 1011 of puncture head

Groove 1012

Inner axial surface 1013 of puncture head

Adjustable elbow sleeve assembly 20

Adjustable bend section 201

Operating space 202

Support section 203

Connecting part 204

Point of sheath exit 205

Traction element 30

First drawn wire 31

Second drawn wire 32

Connecting piece 40

Control handle 200

Housing 50

Accommodating space 501

Spacing space 502

First limit space 5021

Second spacing space 5022

First limit step 503

Second limit step 504

Card slot 505

First housing 51

Second case 52

First connecting seat 53

Bend adjustment assembly 60

Main shaft 61

Opening 6101

Accommodating space 6102

Clamp connector 611

Second connecting seat 6111

Guide cylinder 612

Guide groove 614

Catch 616

Knob 62

First rotary connector 621

Second rotational connection 622

Antiskid structure 6201

Internal thread 6202

Stop 623

Bending adjustment sliding piece 63

First bend adjuster slider 63A

Second bend adjuster slider 63B

Bending regulating slide block 631

External thread 6311

Guide slide block 632

Fixing hole 6321

Support tube 64

Locking member 65

Energy connector 300

Liquid supply pipe 400

Valve 401

The following detailed description will further illustrate the invention in conjunction with the above-described figures.

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. 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.

It should be noted that, in the field of interventional medicine, the end of the instrument close to the operator is generally referred to as the proximal end (i.e., the operating end) and the end of the instrument away from the operator is generally referred to as the distal end (i.e., the insertion end). In particular, distal end refers to the end of the instrument that is freely insertable into the animal or human body. Proximal end refers to the end that is intended for operation by a user or machine or for connection to other devices. Moreover, the use of the terms first, second, etc. do not denote any order or importance, but rather the terms first, second, etc. are used to distinguish one element from another.

It is understood that the terminology used in the description and claims of the present invention and the accompanying drawings described above is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The terms "first," "second," and the like in the description and claims of the present invention and in the above-described drawings are used for distinguishing between different objects and not for describing a particular order. The singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The term "comprises" and any variations thereof is intended to cover non-exclusive inclusions. Furthermore, the present invention may be embodied in many different forms and is not limited to the embodiments described in the present embodiment. The following detailed description is provided for the purpose of providing a more thorough understanding of the present disclosure, and the terms used to indicate orientation, top, bottom, left, right, etc. are merely used to describe the illustrated structure as it may be positioned in the corresponding figures.

While the specification concludes with claims describing preferred embodiments of the invention, it is to be understood that the above description is made only by way of illustration of the general principles of the invention and not by way of limitation of the scope of the invention. The scope of the present invention is defined by the appended claims.

Referring to fig. 1, fig. 1 is a schematic structural diagram of a puncture system 1000 according to an embodiment of the present invention. Piercing system 1000 includes an adjustable bend piercing needle 100 and a control handle 200. The distal end of the control handle 200 is fixedly connected with the proximal end of the adjustable bending puncture needle 100, the proximal end of the control handle 200 is externally connected with an energy generator through an energy connector 300, and the proximal end of the control handle 200 is also externally connected with a liquid supply pipeline 400 with a valve. An energy generator is used in conjunction with the piercing head of adjustable bend spike 100 to provide a source of ablative energy and a fluid supply line 400 is used to deliver fluid.

Wherein the energy generator is used for generating radio frequency, pulse or microwave ablation energy sources and the like. The energy generator is, for example, but not limited to, one of a radio frequency generator, a pulse generator, a microwave generator, or a combination thereof. The proximal end of the liquid supply line 400 is provided with a valve 401. In this embodiment, the valve 401 may be a three-way valve. For example, the first port of the three-way valve is connected with the adjustable bending puncture needle 100 through the liquid supply pipeline 400; the second interface of the three-way valve is connected with the injector through another liquid supply pipeline; the third port of the three-way valve may be left for future use. In other embodiments, the valve 401 may be a two-way valve or other multi-way valve. It should be noted that the valve 401 may be designed according to the requirement of the puncture operation, and the invention is not limited in particular.

It should be understood by those skilled in the art that FIG. 1 is merely an example of lancing system 1000 and does not constitute a limitation on lancing system 1000, and that lancing system 1000 may include more or fewer components than shown in FIG. 1, or some components may be combined, or different components, e.g., lancing system 1000 may also include a transporter, a power supply, etc.

Referring to fig. 2 and 3 together, fig. 2 is a schematic view of a portion of a bendable puncture needle 100, and fig. 3 is a cross-sectional view of the bendable puncture needle 100. The adjustable bending puncture needle 100 is a one-way adjustable bending puncture needle, a two-way adjustable bending puncture needle or a multi-way adjustable bending puncture needle. In this embodiment, the adjustable bend spike 100 is a unidirectional adjustable bend spike.

Adjustable bent introducer needle 100 includes a puncture head 10 and an adjustable bent cannula assembly 20 that is received within puncture head 10. The puncture head 10 is used to puncture a tissue body. The distal end of the adjustable bending sleeve assembly 20 is provided with an adjustable bending section 201. The distal end of the puncture head 10 is exposed outside the adjustable bending section 201. The proximal end of penetration head 10 is secured to the distal end of adjustable bend section 201. The adjustable bending sleeve assembly 20 includes a plurality of layers of tubes with adjustable bending function. The bending-adjustable puncture needle 100 further comprises a traction element 30 arranged among the plurality of layers of tube bodies with bending-adjustable functions, and the distal end of the traction element 30 is fixed on the puncture head 10 or the bending-adjustable section 201.

Therefore, the adjustable bent puncture needle provided by the invention has the advantages that the traction component is arranged in the adjustable bent sleeve component, and the distal end of the traction component is fixed on the puncture head or the adjustable bent section of the adjustable bent sleeve component, so that the adjustable bent puncture needle can drive the puncture head and the adjustable bent sleeve component to freely adjust the direction through the traction component after entering the body of a patient, the puncture head can be more accurately aligned to a target tissue to be punctured (including but not limited to an interatrial space), the adjustable bent puncture needle is prevented from damaging a path of an internal puncture operation, and the interatrial space puncture is more accurate and faster.

By providing the piercing head 10 at the distal end of the adjustable bent cannula assembly 20, the problem of damage to other tissues during the piercing process is avoided and the outer diameter of the piercing needle is reduced. In addition, the traction component 30 is fixed on the puncture head 10 or the adjustable bending section 201 of the adjustable bending sleeve assembly 20, so that the operation is simple and convenient, the fixing efficiency is high, and the structure of the adjustable bending puncture needle 100 is simplified, so that the outer diameter of the adjustable bending puncture needle 100 is smaller. Because the whole external diameter of the adjustable bent puncture needle 100 is smaller, the interatrial puncture is more accurate and faster, the puncture time is saved, and the safety of the puncture operation is improved. Because the traction piece 30 can control the adjustable bending section 201 to bend or restore to be straight, the adjustable bending puncture needle 100 can be freely bent after entering the body of a patient, so that the puncture head 10 can be conveniently delivered to target tissues, and the damage of the adjustable bending puncture needle 100 to the passage of the in-vivo puncture operation can be avoided.

In some embodiments, the pulling element 30 is fixed to the outer axial surface 1011 of the proximal end of the penetration head 10. Thus, the traction piece 30 is directly fixed on the outer axial surface 1011 of the proximal end of the puncture head 10, so that welding sites of the traction piece 30 and the puncture head 10 are increased, the operation is simple and convenient, the fixing efficiency is high, and the structure of the bendable puncture needle is simplified, so that the outer diameter of the bendable puncture needle is smaller. In this embodiment, the interior of the adjustable bending section 201 is recessed to form an operation space 202 corresponding to the connection between the puncture head 10 and the pulling member 30, so as to prevent the adjustable bending section 201 from forming a convex hull at the connection between the puncture head 10 and the pulling member 30, which affects the transportation performance and the connection stability. In addition, the design attenuate of operating space 202 the thickness of adjustable curved section 201 to enable to realize fast that adjustable curved section 201 is crooked or resume straight, and make the interatrial puncture more accurate, quick, practiced thrift the puncture time, and then improved the security of puncture operation.

In another embodiment, referring to fig. 1, 3 and 4-7 together, fig. 4-7 show cross-sectional views of the puncture head 10 and the first to fourth embodiments of the adjustable elbow sleeve assembly 20. The pulling member 30 is embedded in the piercing head 10. Specifically, the outer axial surface 1011 of the proximal end of the penetration head 10 is provided with a groove 1012. The pulling member 30 is fixedly inserted into the recess 1012. Thus, the outer diameter of the bendable puncture needle 100 can be further reduced, so that atrial septal puncture is more accurate and faster, puncture time is saved, and the safety of puncture operation is improved. In other embodiments, the pulling element may be secured to the adjustable bend section by a connecting element, such as a steel ring.

The traction piece 30 is fixedly connected with the puncture head 10 by welding. The pulling member 30 is used for pulling the adjustable bending section 201 to bend or restore to be straight, and has certain strength. In this embodiment, the pulling member 30 is a single structure, but may be a multi-strand structure. The cross-sectional shape of the pulling member 30 may be various shapes such as a circle, and is not particularly limited. The radial cross section of the pulling element 30 should be as small as possible, while having a certain strength to perform the pulling function. The pulling member 30 is a wire, i.e. the pulling member 30 is made of a metallic material. The metal material is, for example, but not limited to, stainless steel, tungsten alloy, cobalt-chromium alloy, or nickel-titanium alloy, and may be made of a polymer having a certain strength, and the material thereof is not specifically limited. In this embodiment, the pulling member 30 is preferably a stainless steel wire.

The multi-layer tube body with adjustable bending function of the adjustable bending sleeve assembly 20 comprises an inner tube 21, an outer sheath tube 23 and a woven mesh tube 22 arranged between the inner tube 21 and the outer sheath tube 23, and a traction member 30 is arranged between the inner tube 21 and the woven mesh tube 22. The outer sleeve 23, the braided mesh tube 22 and the inner tube 21 are connected by fusion. Between the woven mesh tube 22 and the inner tube 21 there is a passage for the pulling element 30 to pass through. Due to the fact that the pulling member 30 is arranged in the channel between the inner tube 21 and the woven mesh tube 22, the pulling member 30 can be pulled along the axial direction of the adjustable bending sleeve assembly 20, so that the pulling force at the proximal end of the pulling member 30 can be transmitted to the distal end of the pulling member 30 more intensively and more accurately, and the puncture is ensured to be more accurate and rapid. In addition, the inner tube 21 is closer to the puncture head 10, so that the distance between the traction piece 30 and the puncture head 10 is shortened, and the traction piece 30 is prevented from being bent in a transition way to influence the connection stability and reliability of the puncture head 10.

It should be noted that the multi-layer pipe with adjustable bending function of the adjustable bending pipe assembly 20 of the present disclosure is not limited to the three pipes, and the adjustable bending pipe assembly 20 may protect more or less pipes, and the present disclosure is not limited specifically.

Wherein, the hardness of the inner tube 21 is less than or equal to the hardness of the outer sheath 23, so that the outer sheath 23 can support and protect the inner tube 21. In the present embodiment, the material of the adjustable bending section of the outer sheath 23 includes, but is not limited to, Polyamide (PA) material with hardness less than or equal to 35 shore (D), the adjustable bending section of the woven mesh tube 22 is woven from stainless steel wire, and the material of the adjustable bending section of the inner tube 21 includes, but is not limited to, PTFE material. Adjustable elbow sleeve assembly 20 further includes a support section 203 attached to the proximal end of adjustable elbow section 201. The material of the support section 203 of the sheath includes, but is not limited to, at least one of a PA material or a polyether block Polyamide (PEBAX) material greater than or equal to 72D, or other suitable polymeric material.

Alternatively, the outer axial surface of the inner tube 21 is configured as a rough surface, and the inner axial surface of the inner tube 21 is configured as a smooth surface, thereby improving the connection stability of the woven mesh tube 22 with the inner tube 21 and ensuring that other elements can be smoothly inserted into the inner tube 21. In the present embodiment, the outer axial face of the inner tube 21 may be formed into a rough surface by an etching process.

Optionally, in order to ensure the transmission of the driving force of the proximal end of the bendable puncture needle 100, and at the same time ensure that it has a flexible function and a bending function to avoid damaging the blood vessel, the length of the bendable section 201 is 4cm to 5cm, which can be adjusted according to the specific operation.

As shown in fig. 2 and 4-7. In this embodiment, a fluid passage 101 is formed between the piercing head 10 and the adjustable bent sleeve assembly 20. The fluid channel 101 comprises at least one water outlet 103. In one embodiment, the pulling member 30 is isolated from the at least one water outlet 103. In other embodiments, a portion of the pulling member 30 is exposed to the at least one water outlet 103.

In this embodiment, the at least one water outlet 103 is located near the distal end of the puncture tip 10. The fluid supply line 400 communicates with the fluid passage 101. The fluid channel 101 is used to transport a fluid. The fluid channel 101 may be used to deliver contrast media, and since the water outlet 103 is close to the distal end of the puncture head 10, the position of the puncture head 10 may be quickly and accurately located, thereby improving the safety of the puncture procedure. In other embodiments, the fluid channel 101 may also be used to deliver fluids such as saline or medicaments.

Referring again to FIG. 4, in the first embodiment, two fluid channels 101 are formed between the puncture head 10 and the adjustable bent sleeve assembly 20. The distal ends of the fluid channels 101 form two water outlets 103 opposite to each other. Both fluid channels 101 are arranged side by side with the piercing head 10. The puncture head 10 is constructed in a flat structure. Each fluid passage 101 is generally semi-cylindrical. The traction piece 30 is embedded on the puncture head 10 and is separated from the two water outlets 103. Specifically, the pulling member 30 is disposed at the connection position of the puncture head 10 and the adjustable bent cannula assembly 20, so as to reduce the outer diameter of the distal end of the adjustable bent puncture needle 100, thereby enabling atrial septal puncture to be more accurate and faster.

Referring again to FIG. 5, in the second embodiment, two fluid channels 101 are formed between the puncture head 10 and the adjustable bent sleeve assembly 20. The distal ends of the fluid channels 101 form two water outlets 103 opposite to each other. Both fluid channels 101 are arranged alongside the piercing head 10. The piercing head 10 is constructed in a double concave molding structure. In this way, the fluid channel 101 has a larger fluid accommodating space, and can deliver more contrast media, and the area of the water outlet 103 is increased, so that the positioning effect on the puncture head 10 can be further improved. The traction piece 30 is embedded on the puncture head 10 and is separated from the two water outlets 103. Specifically, the pulling member 30 is disposed at the connection position of the puncture head 10 and the adjustable bent cannula assembly 20, so as to reduce the outer diameter of the distal end of the adjustable bent puncture needle 100, thereby enabling atrial septal puncture to be more accurate and faster.

Referring to fig. 6 again, in the third embodiment, the distal end of the fluid channel 101 is correspondingly formed with four water outlets 103 opposite to each other. Four fluid channels 101 are formed between the puncture head 10 and the adjustable bent sleeve assembly 20 in pairs. Four fluid channels 101 are provided alongside the piercing head 10. The puncture head 10 is configured in a prismatic structure. The puncture head 10 includes four corners. The four corners are shaped to match the inner circumference of the casing 43 to increase the contact area between the puncture head 10 and the adjustable angle bend casing assembly 20, thereby improving the stability of the connection between the puncture head 10 and the adjustable angle bend casing assembly 20. Thus, based on the four water outlets 103 uniformly distributed in the circumferential direction of the puncture head 10, the visual experience in use is effectively improved, that is, the positions of the water outlets 103 can be observed from different angles, so that the position of the puncture head 10 can be quickly and accurately positioned. Furthermore, in case of a blockage of one of the water outlets 103, fluid may still flow out of the remaining water outlets 103, thereby reducing the risk of a puncture procedure and enabling a more uniform delivery of fluid to the surgical site of the patient. The traction member 30 is embedded in the puncture head 10 and exposed out of one of the water outlets 103. Specifically, the traction component 30 is disposed at a position of the puncture head 10 exposed out of the water outlet 103, so as to ensure the connection stability of the puncture head 10 and the adjustable bent cannula assembly 20, and simultaneously, the outer diameter of the distal end of the adjustable bent puncture needle 100 can be reduced, thereby enabling atrial septal puncture to be more accurate and rapid.

Referring again to FIG. 7, in the fourth embodiment, a fluid pathway 101 is formed between the puncture head 10 and the adjustable bent sleeve assembly 20. The distal end of the fluid passage 101 correspondingly forms a diametrically opposite one of the water outlets 103. The fluid channel 101 is arranged alongside the piercing head 10. The puncture head 10 is constructed in a semi-cylindrical structure. In this way, the fluid channel 101 can deliver more contrast media and the area of the water outlet 103 is increased to avoid blockage of the water outlet 103, which also greatly improves the positioning effect on the puncture head 10. The traction piece 30 is embedded on the puncture head 10 and is isolated from a water outlet 103. Specifically, the pulling member 30 is disposed at the connection position of the puncture head 10 and the adjustable bent cannula assembly 20, so as to reduce the outer diameter of the distal end of the adjustable bent puncture needle 100, thereby enabling atrial septal puncture to be more accurate and faster.

Referring again to fig. 2 and 3, the distal end of the piercing head 10 forms a closed flexible tip 11, and the flexible tip 11 is configured as a rounded transition structure. In this way, the puncture head 10 can be prevented from scratching the non-puncture site of the operator or the patient during the puncture operation. The puncture tip 10 has a cavity 12 in the axial direction, and the distal end of the cavity 12 is filled with a developing block 13. In some embodiments, the visualization block 13 is near the distal end of the puncture tip 10. In this way, the position of the puncture head 10 can be further positioned during the puncture operation, and the positioning effect on the puncture head 10 can be further improved. The material of the developing block 13 includes, but is not limited to, at least one of tantalum alloy, platinum-iridium alloy, platinum-tungsten alloy, and gold.

In this embodiment, the adjustable bend introducer needle 100 also includes an electrical guidewire 14 disposed within the adjustable bend cannula assembly 20. The distal end of the electrical guidewire 14 is electrically connected to the puncture head 10. The proximal end of the electrical guidewire 14 is externally connected to an energy generator via an energy source connector 300. Specifically, the proximal end of the cavity 12 is plugged with an electrical guidewire 14. The electrical wire 14 may be fixedly attached to the inner axial surface 1013 (i.e., the inner wall of the cavity 12) of the puncture tip 10 by welding, crimping, or the like. The cavity 12 extends parallel to the axial direction of the puncture tip 10 to ensure good contact performance between the electrical wire 14 and the puncture tip 10. Preferably, the outer diameter of the electrical guide wire 14 is slightly smaller than the inner diameter of the cavity 12 of the puncture head 10, so that the outer circumferential wall of the electrical guide wire 14 is more conformable to the inner circumferential wall of the cavity 12 of the puncture head 10. The electrical guidewire 14 may include an insulated section that plugs into the puncture tip 10 and a non-insulated section that is within the adjustable elbow sleeve assembly 20.

The proximal end of adjustable elbow sleeve assembly 20 circumscribes control handle 200. The proximal end of the pulling member 30 is secured to the control handle 200. The control handle 200 is used to control the pulling element 30 to move towards the proximal end or the distal end of the control handle 200, so as to bend or straighten the adjustable bending section 201 in at least one direction, so as to facilitate the delivery of the puncture head 10 to the target tissue, and further avoid the damage of the adjustable bending puncture needle 100 to the pathway of the intracorporeal puncture operation, thereby the puncture operation is more accurate and rapid.

Referring to fig. 1 and 8-9, the control handle 200 includes a housing 50 and a bending adjustment assembly 60 disposed on the housing 50. The bending adjustment assembly 60 includes a main shaft 61, a knob 62 and a bending adjustment slider 63. The knob 62 rotates relative to at least one of the spindle 61 and the housing 50 along a central axis P1 of the knob 62. The bending adjustment sliding member 63 is movably disposed in the knob 62, the proximal end of the adjustable bending sleeve assembly 20 is inserted into the main shaft 61, and the pulling member 30 disposed in the adjustable bending sleeve assembly 20 extends from the proximal end of the adjustable bending sleeve assembly 20 and is fixed to the bending adjustment sliding member 63. The knob 62 is used to move the bending slider 63 toward the proximal end or the distal end of the control handle 200, so as to bend or straighten the adjustable bending section 201 in at least one direction.

In the present embodiment, the housing 50 includes a first housing 51 and a second housing 52 that are fitted and fixed to each other. The first housing 51 and the second housing 52 together enclose an accommodating space 501. The proximal end portion of the spindle 61 is accommodated in the accommodating space 501. The first housing 51 and the second housing 52 may be detachably coupled together by a mounting structure. The mounting structure includes, but is not limited to, a snap structure, a sliding guide structure, a magnetic attraction structure, an internal and external thread structure, a latch structure, and the like. In some embodiments, the first housing 51 and the second housing 52 may also be integrally formed.

Optionally, the main shaft 61, the knob 62 and the housing 50 together enclose a limiting space 502, and the bending adjustment sliding member 63 moves in the limiting space 502. Specifically, a first limit step 503 is formed at a connection position of the knob 62 and the spindle 61, a second limit step 504 is formed at a connection position of the knob 62 and the housing 50, and the first limit step 503 and the second limit step 504 are used for being stopped by the bending adjustment sliding member 63, so as to limit the movement of the bending adjustment sliding member 63 in the limit space 502. In this way, it is ensured that the knob 62 and the bending adjustment slider 63 are always in fit connection, so that the knob 62 drives the bending adjustment slider 63 to move and pulls the traction member 30 to move towards the proximal end or the distal end of the control handle 200. In addition, the design of the first limit step 503 and the second limit step 504 can also limit the axial movement range of the bending adjustment sliding part 63, so as to avoid the performance of the bending adjustment section 201 from being affected by excessive bending.

Spindle 61 includes a snap fitting 611 and a guide barrel 612 extending from a proximal end of snap fitting 611 along a central axis P1 of spindle 61. The adjustable bending sleeve assembly 20 is sequentially inserted into the clamping head 611 and the guide cylinder 612, the bending adjusting sliding member 63 is movably sleeved outside the guide cylinder 612, and the knob 62 is clamped between the clamping head 611 and the housing 50.

In the present embodiment, the knob 62 is configured as a cylindrical barrel. The outer peripheral surface of the knob 62 is provided with an anti-slip structure 6201, so that a user can conveniently rotate the knob 62, and the user use experience is improved. The knob 62 is rotatable relative to the spindle 61 and the housing 50 along a central axis P1 of the knob 62, i.e., both ends of the knob 62 are rotatably connected to the spindle 61 and the housing, respectively. Specifically, the two ends of the knob 62 are respectively provided with a first rotating connector 621 and a second rotating connector 622 which are opposite to each other. The distal end of the housing 50 is provided with a first connecting seat 53 rotatably connected to the first rotating connector 621, and the proximal end of the clamping joint 611 is provided with a second connecting seat 6111 rotatably connected to the second rotating connector 622.

Specifically, one of the first rotating link 621 and the first coupling seat 53 is configured as a groove, and the other of the first rotating link 621 and the first coupling seat 53 is configured as a protrusion rotatably coupled with the groove. One of the second rotary connector 622 and the second connector holder 6111 is configured as a groove, and the other of the second rotary connector 622 and the second connector holder 6111 is configured as a protrusion rotatably connected with the groove. In the present embodiment, the first rotating connector 621 is configured as a protrusion, and the first connector seat 53 is provided with a groove rotatably engaged with the protrusion. The second rotary connector 622 is configured as a groove, and the second connecting socket 6111 is provided with a protrusion which is rotatably matched with the groove. It should be noted that the knob 62 may be connected to the spindle 61 and the housing 50 in other ways, and the invention is not limited in particular.

The bend adjustment slider 63 includes a bend adjustment slider 631 that is rotatably engaged with the knob 62. The bending slider 631 is configured as a threaded sleeve with an external thread 6311, and the knob 62 is configured as a threaded cylinder with an internal thread 6202 and threaded with the external thread 6311 of the threaded sleeve. In some embodiments, the pulling member 30 passes through the adjustable bending sleeve assembly 20 and the guiding cylinder 612 to be fixed on the inner axial surface of the threaded sleeve.

In this embodiment, the guide cylinder 612 is provided with a guide groove 614 along the axial direction, and the bending adjustment sliding member 63 further includes a guide sliding block 632 disposed on the bending adjustment sliding block 631 and engaged with the guide groove 614. The guide block 632 is provided with a fixing hole 6321. The pulling member 30 is fixed in the fixing hole 6321, and the turning knob 62 is rotated to drive the bending slider 631 to move axially relative to the turning knob 62, and the guiding slider 632 moves along the guiding groove 614 to control the pulling member 30 to move towards the proximal end or the distal end of the control handle 200.

The traction element 30 comprises at least one drawing wire, the number of bending sliders 63 corresponding to the number of said at least one drawing wire. In this embodiment, the pulling member 30 comprises a pull wire. The adjustable bending puncture needle 100 can realize the bending of the adjustable bending section 201 towards a preset direction by pulling a single wire. The preset direction refers to a direction in which the adjustable bending section 201 bends towards a side close to the wire drawing. In some embodiments, the number of the wires may be multiple, and the bending of the bendable section 201 in multiple predetermined directions may be achieved by pulling the multiple wires.

The control handle 200 also includes a support tube 64 fixedly disposed within the main shaft 61. The distal end of the support tube 64 is fixedly attached within the proximal end of the adjustable bending sleeve assembly 20 and is used to sheath the proximal end of the electrical guidewire 14. The support tube 64 is used to support and protect the electrical wire 14, thereby ensuring good contact between the electrical wire 14 and the puncture head 10. In addition, the design of the support tube 64 enhances the strength of the proximal end of the adjustable elbow sleeve assembly 20, thereby avoiding the problem of bending or breaking of the adjustable elbow sleeve assembly 20 near the exit position of the pulling member 30, and further ensuring the smooth implementation of the elbow function of the adjustable elbow sleeve assembly 20.

The distal end of support tube 64 is inserted into the proximal end of adjustable elbow sleeve assembly 20. The proximal end of the adjustable elbow sleeve assembly 20 is provided with a sheath exit point 205 for the tractor 30 to exit the adjustable elbow sleeve assembly 20. The distance between the sheath exit point 205 and the proximal face of the adjustable bending sleeve assembly 20 is less than or equal to the axial connection length L1 between the support tube 64 and the adjustable bending sleeve assembly 20 to avoid bending or breaking of the attachment of the adjustable bending sleeve assembly 20 at the exit position of the pulling assembly 30.

The distal end of the main shaft 61 is provided with an opening 6101 for holding the adjustable elbow sleeve assembly 20. The proximal end of the main shaft 61 is provided with a receiving space 6102 along the axis for receiving the support tube 64 and communicating with the opening 6101. The adjustable elbow sleeve assembly 20 includes a connecting portion 204 passing through the main shaft 61 and exposed in the accommodating space 6102. The length of the connection between the support tube 64 and the adjustable elbow sleeve assembly 20 is less than or equal to the axial length L2 of the connection 204. Preferably, the connection length L1 between the support tube 64 and the adjustable bending sleeve assembly 20 is equal to the axial length L2 of the connection portion 204, so as to ensure sufficient radial and axial support of the proximal end of the adjustable bending sleeve assembly 20.

The interior of the guide cylinder 612 is also provided with a catch 616 for catching the support tube 64 to ensure the stability of the connection between the support tube 64 and the adjustable bending sleeve assembly 20. The support tube 64 is made of a rigid material, such as steel tubing. The control handle 200 also includes a retaining member 65 for retaining the proximal end of the electrical guidewire 14 and/or support tube 64. The first housing 51 and the second housing 52 form a catching groove 505 for catching the locking member 65 at a position corresponding to the locking member 65. In addition, the locking member 65 can be used for connecting the liquid supply pipeline 400 through the tail end, and for connecting the electric guide wire 14 with an external energy generator through the tail end connecting energy source connector 300. In this embodiment, referring to fig. 1 to 9 again, the bendable puncture needle 100, the control handle 200 and the energy generator are a complete system, and the operation method of the puncture system 1000 of this embodiment is as follows: after the delivery catheter is introduced into the body through percutaneous puncture, the adjustable bending puncture needle 100 is inserted into the body along the delivery catheter, the position of the puncture head 10 is determined by observing the visualization point, and after the puncture head 10 approaches a target position (for example, interatrial septum tissue), the adjustable bending puncture needle 100 is bent by the control handle 200 until the puncture head 10 is aligned with the target puncture position. Specifically, when the adjustable bending section 201 is in a flat state, when the left-handed knob 62 is rotated, the bending slider 63 moves towards the proximal end of the control handle 200, and because both ends of the traction member 30 are respectively and fixedly connected to the puncture head 10 and the bending slider 63, when the bending slider 63 drives the traction member 30 to gradually move towards the proximal end of the control handle 200, the pulling force of the traction member 30 is gradually increased to drive the puncture head 10 to bend towards the proximal end, and along with the gradual increase of the displacement of the traction member 30, the bending degree of the adjustable bending section 201 is also gradually increased. When the knob 62 is rotated by the right hand, the bending slider 63 moves towards the distal end of the control handle 200, and since the two ends of the pulling member 30 are fixedly connected to the puncturing head 10 and the bending slider 63 respectively, when the bending slider 63 drives the pulling member 30 to move towards the distal end of the control handle 200, the pulling force of the pulling member 30 is gradually reduced to drive the puncturing head 10 to gradually return to the straight state. When the pulling force is removed by the pulling member 30, the piercing head 10 is restored to the original straight state. When the puncture head 10 is aligned with the target puncture position, the external energy generator is connected to start ablation puncture, and the adjustable bending puncture needle 100 is slowly pushed forward at a constant speed until the developing point passes through the interatrial septum to reach the left atrium. The radio frequency connection of the energy generator is disconnected, and the whole adjustable bending puncture needle 100 is retracted, so that the puncture process of the interatrial septum tissue is realized.

According to the adjustable bent puncture needle provided by the invention, the traction component is arranged in the adjustable bent sleeve component, and the distal end of the traction component is fixed on the puncture head or the adjustable bent section of the adjustable bent sleeve component, so that the direction of the adjustable bent puncture needle can be freely adjusted by driving the puncture head and the adjustable bent sleeve component through the traction component after the adjustable bent puncture needle enters a patient body, the puncture head can be more accurately aligned with a target tissue to be punctured, further, the adjustable bent puncture needle is prevented from damaging a path of an in-vivo puncture operation, and the interatrial puncture is more accurate and faster.

Referring to fig. 1, 10 to 11, fig. 10 is a schematic structural diagram of a puncture system 2000 according to a second embodiment of the present invention. In the second embodiment, the puncture system 2000 is different from the puncture system 1000 in the first embodiment.

The puncture system 2000 in the second embodiment has a structure similar to that of the puncture system 1000 in the first embodiment, except that the pulling member 30 includes a first wire 31 and a second wire 32. The bend adjustment slider 63 includes a first bend adjustment slider 63A and a second bend adjustment slider 63B. The distal ends of the first wire 31 and the second wire 32 are fixed to the puncture head 10 or the adjustable bending section 201. The proximal end of the first wire 31 is fixed on the first bending adjusting sliding piece 63A, the proximal end of the second wire 32 is fixed on the second bending adjusting sliding piece 63B, and the first bending adjusting sliding piece 63A and the second bending adjusting sliding piece 63B move in opposite directions. The first wire 31 and the second wire 32 are symmetrically distributed from the central axis of the puncture tip 10, so that the adjustable bending section 201 can be bent in different preset directions.

Referring to fig. 11-12, there are shown in fig. 11-12 cross-sectional views of various embodiments of piercing head 10 and adjustable bent cannula assembly 20 of adjustable bent introducer needle 100 of piercing system 2000 along the axial direction of adjustable bent introducer needle 100. As shown in fig. 11, in the first embodiment, the distal ends of the first and

second wires

31 and 32 are fixed to the puncture tip 10. The first and

second wires

31 and 32 are welded to the outer axial surface 1011 of the puncture tip 10. Because the first wire drawing 31 and the second wire drawing 32 are directly welded on the outer axial surface 1011 of the puncture head 10, the operation is simple and convenient, the fixing efficiency is high, and the structure of the adjustable bending puncture needle 100 is simplified, so that the outer diameter of the adjustable bending puncture needle 100 is relatively smaller, and the atrial septal puncture is more accurate and faster.

As shown in fig. 12, in the second embodiment, the outer axial surface 1011 of the proximal end of the penetration head 10 is formed with two opposing grooves 1012. The first wire 31 and the second wire 32 are fixedly inserted into the two grooves 1012, respectively. Therefore, the outer diameter of the near end of the bending-adjustable puncture needle 100 can be further reduced, so that atrial septal puncture is more accurate and faster, puncture time is saved, and the safety of puncture operations is improved.

In a third embodiment, as shown in fig. 13, the distal ends of the first wire 31 and the second wire 32 are fixed to the inner wall of the adjustable bending section 201 by a connecting member 40. Specifically, the distal ends of the first wire 31 and the second wire 32 are fixed to the inner wall of the adjustable bending section 201 of the sheath tube 21 by a connector, and are disposed adjacent to the puncture tip 10. The connector 40 is substantially annular. The connecting member 40 is made of a rigid material. The connector 40 is a steel ring, and the inner wall of the outer sheath tube 21 is provided with an accommodating groove for accommodating the steel ring, so that the bulge problem caused by inserting the steel ring in the adjustable bent sleeve assembly 20 can be avoided.

Referring to fig. 14-17, fig. 14-17 show cross-sectional views of various embodiments of a puncture head 10 and an adjustable bent cannula assembly 20 of an adjustable bent puncture needle 100 of a puncture system 2000 along a radial direction of the adjustable bent puncture needle 100. As shown in fig. 14 and 15, two fluid channels 101 are formed between the puncture head 10 and the adjustable bent cannula assembly 20. The first wire drawing 31 and the second wire drawing 32 are both arranged on the puncture head 10 and are isolated from the two fluid channels 101, so that the phenomenon that the fluid flow direction is influenced to the position to be punctured due to the fact that the water outlet 103 is blocked by the first wire drawing 31 and the second wire drawing 32 is avoided.

As shown in fig. 16, four fluid channels 101 are formed between the puncture head 10 and the adjustable bent cannula assembly 20, and each fluid channel 101 includes an outlet 103. The first wire 31 and the second wire 32 are partially exposed to the at least one water outlet 103. Specifically, the first wire 31 and the second wire 32 are provided on the puncture head 10. The first wire drawing 31 and the second wire drawing 32 are respectively and partially exposed in the corresponding fluid channel 101, so that the bending direction of the adjustable bending section 201 can be freely adjusted under the pulling of the traction piece 30, and the area of the water outlet 103 is ensured, so that the water outlet 103 is prevented from being blocked by the first wire drawing 31 and the second wire drawing 32 to influence the fluid flow direction to the position to be punctured.

As shown in FIG. 17, a fluid passage 101 is formed between the piercing head 10 and the adjustable bent cannula assembly 20, and the fluid passage 101 includes an outlet 103. Portions of the first wire 31 and the second wire 32 are exposed to the water outlet 103. Specifically, the first wire 31 and the second wire 32 are provided on the puncture head 10. The first wire drawing 31 and the second wire drawing 32 are respectively and partially exposed in the fluid channel 101, so that the bending direction of the adjustable bending section 201 can be freely adjusted under the pulling of the traction piece 30, and the area of the water outlet 103 is ensured, so that the water outlet 103 is prevented from being blocked by the first wire drawing 31 and the second wire drawing 32 to influence the fluid flow direction to the position to be punctured.

Referring to fig. 11 and 18 together, a cross-sectional view of a portion of the lancing system 2000 of fig. 18 is shown. The first rotary connector 621 and the second rotary connector 622 of the knob 62 are both configured as protrusions, the first connecting seat 53 and the second connecting seat 6111 are grooves rotationally matched with the protrusions, that is, the first rotary connector 621 is rotationally inserted into the distal end of the housing 50, and the second rotary connector 622 is inserted into the groove axially formed around the guide cylinder 612 in the clamping head 611.

A stop 623 is also provided at the middle of the inner sidewall of the knob 62. The stopping member 623 divides the limiting space 502 into a first limiting space 5021 and a second limiting space 5022 which are independent from each other, and stops the first bend adjusting slider 63A and the second bend adjusting slider 63B, so that the first bend adjusting slider 63A moves in the first limiting space 5021, and the second bend adjusting slider 63B moves in the second limiting space 5022. The stop 623 includes, but is not limited to, an unthreaded section provided between the first and

second spacing spaces

5021 and 5022, or a flange. Internal threads are arranged in the first limiting space 5021 and the second limiting space 5022 of the knob 62, and the inner diameter of the non-threaded section of the knob 62 is smaller than or equal to that of the threaded section of the knob 62.

The structures of the puncture head 10, the adjustable bent sleeve assembly 20, the traction member 30, the control handle 200, the energy generator and the liquid supply line 400 in the puncture system 1000 in the first embodiment are suitable for the puncture head 10, the adjustable bent sleeve assembly 20, the traction member 30, the control handle 200, the energy generator and the liquid supply line 400 in the puncture system 2000 in the second embodiment, and the description of the invention is omitted.

In this embodiment, referring to fig. 11 to fig. 18 again, the bendable puncture needle 100, the control handle 200 and the energy generator are a complete system, and the operation method of the puncture system 2000 of this embodiment is as follows: after the delivery catheter is introduced into the body through percutaneous puncture, the bendable puncture needle 100 is inserted into the body along the delivery catheter, the position of the puncture head 10 is determined by observing the visualization point, and after the puncture head 10 approaches a target position (for example, interatrial septum tissue), the bendable puncture needle 100 is bent by the control handle 200 until the puncture head 10 is aligned with the target puncture position. Specifically, when the adjustable bending section 201 is in a flat state, when the knob 62 is rotated rightly, the first bending adjustment sliding member 63A moves towards the distal end of the control handle 200, and the second bending adjustment sliding member 63B moves towards the proximal end of the control handle 200, so as to drive the first wire drawing 31 to advance towards the distal end of the control handle 200, and drive the second wire drawing 32 to advance towards the proximal end of the control handle 200, so as to realize that the adjustable bending section 201 is bent towards a first direction, wherein the first direction is a direction in which the adjustable bending section 201 is bent towards one side close to the second wire drawing 32, that is, a direction in which one side away from the first wire drawing 31 is bent. When the adjustable bending section 201 is bent to the maximum bending angle, the first bending slider 63A is stopped by the first limit step 503, and the second bending slider 63B is stopped by the second limit step 504, that is, the first bending slider 63A moves to the position of the farthest end of the first limit space 5021, and the second bending slider 63B moves to the position of the nearest end of the second limit space 5022. When the adjustable bending section 201 is straightened, the knob 62 is rotated left, and at this time, the first bending adjustment slider 63A moves towards the proximal direction of the control handle 200, and the second bending adjustment slider 63B moves towards the distal direction of the control handle 200, until the first bending adjustment slider 63A and the second bending adjustment slider 63B move to the initial positions, respectively, wherein the initial positions refer to the middle position where the first bending adjustment slider 63A is located in the first limit space 5021 and the middle position where the second bending adjustment slider 63B is located in the second limit space 5022.

When the adjustable bending section 201 is in the flat state and the knob is rotated left, the first bending adjustment sliding part 63A moves towards the proximal end of the control handle 200, and the second bending adjustment sliding part 63B moves towards the distal end of the control handle 200, so as to drive the first wire drawing 31 to advance towards the proximal end of the control handle 200 and drive the second wire drawing 32 to advance towards the distal end of the control handle 200, so as to realize that the adjustable bending section 201 is bent towards a second direction, wherein the second direction is opposite to the first direction. The second direction is a direction in which the adjustable bending section 201 is bent toward a side close to the first wire 31, i.e., a side away from the second wire 32. When the bending angle of the adjustable bending section 201 is adjusted to the maximum bending angle, the first bending adjustment slider 63A is stopped by the stop member 623, and the second bending adjustment slider 63B is stopped by the stop member 623, i.e., the first bending adjustment slider 63A moves to the position at the most proximal end of the first limiting space 5021, and the second bending adjustment slider 63B moves to the position at the most distal end of the second limiting space 5022. When the adjustable bending section 201 is straightened, the knob 62 is rotated, and at this time, the first bending adjustment slider 63A moves towards the distal end of the control handle 200, and the second bending adjustment slider 63B moves towards the proximal end of the control handle 200, until the first bending adjustment slider 63A and the second bending adjustment slider 63B move to the initial positions, respectively, wherein the initial positions refer to the middle position where the first bending adjustment slider 63A is located in the first limit space 5021 and the middle position where the second bending adjustment slider 63B is located in the second limit space 5022.

When the puncture head 10 is aligned with the target puncture position, the energy connector 300 is connected with the external energy generator to start ablation puncture, and the adjustable bending puncture needle 100 is slowly pushed forwards at a constant speed until the development point passes through the interatrial septum to reach the left atrium. The radio frequency connection of the energy generator is disconnected, and the whole adjustable bending puncture needle 100 is retracted, so that the puncture process of the interatrial septum tissue is realized.

According to the adjustable bent puncture needle provided by the invention, the traction component is arranged in the adjustable bent sleeve component, and the distal end of the traction component is fixed on the puncture head or the adjustable bent section of the adjustable bent sleeve component, so that the direction of the adjustable bent puncture needle can be freely adjusted by driving the puncture head and the adjustable bent sleeve component through the traction component after the adjustable bent puncture needle enters a patient body, the puncture head can be more accurately aligned with a target tissue to be punctured, further, the adjustable bent puncture needle is prevented from damaging a path of an in-vivo puncture operation, and the interatrial puncture is more accurate and faster. In addition, through set up first accent curved slider and second accent curved piece at control handle to through levogyration or dextrorotation knob and realize that adjustable curved section is crooked towards two different directions, and then can adjust the direction of adjustable curved pjncture needle in the puncture operation in a flexible way, so that the puncture operation is more accurate, quick.

The above embodiments of the present invention are described in detail, and the principle and the implementation of the present invention are explained by applying specific embodiments, and the above description of the embodiments is only used to help understanding the method of the present invention and the core idea thereof; meanwhile, for a person skilled in the art, according to the idea of the present invention, there may be variations in the specific embodiments and the application scope, and in view of the above, the content of the present specification should not be construed as a limitation to the present invention.

Claims

1. An adjustable puncture needle, characterized in that it comprises a puncture head and a bendable sleeve assembly sleeved with the puncture head; the puncture head is used to puncture a tissue body; the adjustable bendable sleeve The distal end of the tube assembly is provided with an adjustable bendable section, the distal end of the puncture head is exposed outside the adjustable bendable section, and the proximal end of the puncture head is fixed on the distal end of the adjustable bendable section; The bendable cannula assembly includes multiple layers of tubular bodies with an adjustable bendable function, and the bendable puncture needle further includes a traction member disposed between the multiple layers of tubular bodies with an adjustable bendable function. The distal end of the traction member is fixed on the puncture head or the adjustable bendable segment.

2. The adjustable puncture needle according to claim 1, wherein the traction member is fixed on the outer axial surface of the proximal end of the puncture head; A groove is formed on the axial surface, and the traction member is fixedly embedded in the groove.

3. The adjustable puncture needle according to claim 1, wherein the multi-layered tube body with adjustable bendable function of the bendable sleeve assembly comprises an inner tube, an outer sheath, and a A braided mesh tube between the inner tube and the outer sheath tube, and the traction member is arranged between the inner tube and the braided mesh tube.

4 . The adjustable puncture needle according to claim 3 , wherein the traction member is fixed on the inner wall of the adjustable bendable section of the outer sheath tube through a connector, and is arranged adjacent to the puncture head. 5 . .

5 . The adjustable puncture needle according to claim 4 , wherein the connecting piece is a steel ring, and a receiving groove for receiving the steel ring is defined on the inner wall of the outer sheath. 6 .

6. The adjustable puncture needle according to claim 3, wherein the material of the adjustable section of the outer sheath tube comprises a PA material with a hardness of less than or equal to 35D, and the adjustable section of the braided mesh tube is made of PA material. Braided by stainless steel wire, the material of the adjustable bendable section of the inner tube includes PTFE material.

7. The bendable puncture needle according to claim 1, wherein the length of the bendable section is 4 cm to 5 cm.

8. The adjustable puncture needle according to claim 1, wherein a control handle is externally connected to the proximal end of the adjustable cannula assembly, the proximal end of the traction member is fixed to the control handle, and the control handle is The handle is used to control the movement of the traction member toward the proximal end or the distal end of the control handle, so as to bend or straighten the adjustable segment in at least one direction.

9 . The adjustable puncture needle according to claim 8 , wherein the control handle comprises a casing and a bending assembly arranged on the casing, and the bending assembly comprises a main shaft, a knob and a bending adjustment 9 . a bending sliding piece, the knob rotates along the central axis of the knob relative to at least one of the main shaft and the housing, the bending sliding piece is movably arranged in the knob, the adjustable bending The proximal end of the sleeve assembly is passed through the main shaft, and the traction member disposed in the adjustable bending sleeve assembly protrudes from the proximal end of the adjustable bending sleeve assembly and is fixed to the bending adjustment On the sliding member, the knob is used to drive the bending sliding member to move toward the proximal end or the distal end of the control handle, so that the adjustable bending section is bent or straightened in at least one direction, and the main shaft is , the knob and the casing are jointly formed to form a limiting space, and the bending sliding member moves in the limiting space.

10. The adjustable puncture needle according to claim 9, wherein the main shaft comprises a clip joint and a guide cylinder extending from the proximal end of the clip joint along the central axis of the main shaft, the adjustable bend The sleeve assembly is successively passed through the clip joint and the guide cylinder, the bending sliding piece is movably sleeved outside the guide cylinder, and the knob is clamped between the clip joint and the housing between.

11. The adjustable puncture needle according to claim 10, wherein the bending sliding member comprises a bending sliding block rotatably matched with the knob, and the bending sliding sliding block is configured to have an external thread. A threaded sleeve, the knob is configured as a rotary cylinder with an internal thread and is screwed with the external thread of the threaded sleeve, and the traction member passes through the adjustable-bendable sleeve assembly and the guide cylinder in sequence to It is fixedly arranged on the inner axial surface of the threaded sleeve.

12 . The adjustable puncture needle according to claim 11 , wherein a guide groove is provided on the guide cylinder along the axial direction, and the bend adjustment sliding member further comprises a bend adjustment slider which is arranged on the bend adjustment slider and is connected with the bend adjustment slider. 13 . The guide block matched with the guide groove, the guide block is provided with a fixing hole, the traction member is fixed in the fixing hole, and the bending adjustment block is driven by rotating the knob relative to the knob. Axially moves, and moves the guide block along the guide groove to control the pulling member to move toward the proximal end or the distal end of the control handle.

13 . The adjustable puncture needle according to claim 9 , wherein the pulling member comprises at least one drawing wire, and the number of the adjustable bending sliding member corresponds to the number of the at least one drawing wire. 14 .

14. The adjustable puncture needle according to claim 13, wherein the at least one drawing wire comprises a first drawing wire and a second drawing wire, and the bending sliding member comprises a first bending sliding member and a second adjusting wire. Bending sliding piece, the distal ends of the first drawing wire and the second drawing wire are fixed on the puncture head or the adjustable bending section, and the proximal end of the first drawing wire is fixed on the first bending On the sliding member, the proximal end of the second wire drawing is fixed on the second bending sliding member, and the first bending sliding member and the second bending sliding member move in opposite directions, and the first bending The drawing wires and the second drawing wires are symmetrically distributed from the central axis of the puncture head.

15. The adjustable puncture needle according to claim 13, wherein a fluid channel is formed between the puncture head and the adjustable cannula assembly, and the fluid channel comprises at least one water outlet, each The drawing wire is isolated from the at least one water outlet; or, at least part of the drawing wire is exposed to the at least one water outlet.

16. The bendable puncture needle according to claim 9, wherein the bendable puncture needle further comprises an electrical guide wire disposed in the bendable cannula assembly, the distal end of the electrical guide wire The puncture head is electrically connected, and the proximal end of the electrical guide wire is electrically connected to the energy generator; the control handle also includes a support tube fixedly arranged in the main shaft, and the distal end of the support tube is fixedly connected to the adjustable on the proximal end of the bending sleeve assembly, and used for wrapping the proximal end of the electrical guide wire.

17. The bendable puncture needle according to claim 16, wherein the distal end of the support tube is inserted into the proximal end of the bendable sleeve assembly, the bendable sleeve assembly The proximal end is provided with a sheathing point for the traction member to pass through the adjustable bendable sleeve assembly, and the distance between the sheathed point and the proximal end surface of the adjustable bendable sleeve assembly is less than or equal to the The length of the axial connection between the support tube and the adjustable bendable sleeve assembly.

18 . The adjustable puncture needle according to claim 16 , wherein the distal end of the main shaft is provided with an opening that is clamped with the bendable sleeve assembly, and the proximal end of the main shaft is along the axis. 19 . A accommodating space for accommodating the support tube and communicating with the opening is opened, and the adjustable bendable sleeve assembly includes a connecting portion that penetrates through the main shaft and is exposed in the accommodating space, and the support tube The length of connection with the bendable sleeve assembly is less than or equal to the axial length of the connection portion.

19. The adjustable puncture needle according to claim 16, wherein the puncture head is provided with a cavity along the axial direction, the distal end of the cavity is filled with a developing block, and the proximal end of the cavity is inserted into the cavity. Connect the conductive wire.

20. A puncture system, characterized by comprising a control handle and the adjustable puncture needle according to any one of claims 1-19, the distal end of the control handle and the proximal end of the adjustable puncture needle Fixed connection, the proximal end of the control handle is connected to an external energy generator and a liquid supply pipeline with a valve, the energy generator is used to connect with the puncture head to provide ablation energy, and the liquid supply pipeline is used to transport fluid.