WO2022127905A1 - Bendable puncture device and puncture system - Google Patents

Abstract

A bendable puncture device (100), comprising a puncture head (10) and a bendable sleeve assembly (20). The puncture head (10) is used for puncturing tissues; a distal end of the bendable sleeve assembly (20) is provided with a bendable section (201); a distal end of the puncture head (10) is exposed out of the bendable section (201); a proximal end of the puncture head (10) is fixed to the distal end of the bendable section (201); and the bendable sleeve assembly (20) comprises a tube body having a bendable function. The bendable puncture device (100) further comprises a traction member (30) in the tube body having a bendable function; and the distal end of the traction member (30) is fixed to the puncture head (20) or the bendable section (201), such that the puncture head (10) can be more accurately aligned with target tissues to be punctured, the damage of the bendable puncture device (100) to a passage for puncture operation in the body can be prevented, and the puncture is more accurate and fast.

Description

Adjustable puncture device and puncture system

This application claims the priority of the Chinese patent application with the application number of 2020115015861 and the application title of "Adjustable Puncture Needle and Puncture System" filed with the Chinese Patent Office on December 18, 2020, the entire contents of which are incorporated herein by reference middle.

technical field

The invention relates to the technical field of medical instruments, in particular to an adjustable puncture device and a puncture system.

Background technique

With the rapid development of interventional equipment and equipment, the application of cardiac interventional therapy has become more and more extensive, which makes atrial septocentesis more widely used. In transseptal puncture, a catheter is usually used as an adjunct to interventional procedures to puncture the atrial septum. However, in atrial transseptal puncture, precise control of the puncture position is required to avoid the problem of accidental puncture of the surrounding tissue and damage to the heart.

However, the existing puncture device cannot adjust the bend, so that the tissue is easily scratched during the puncture operation, and the puncture is not accurate and time-consuming.

technical problem

The main purpose of the present application is to provide a bendable puncture device and a puncture system, so as to solve the problems that the puncture device cannot be adjusted, and the tissue is easily scratched during the puncture operation, and the puncture is not accurate and time-consuming.

technical solutions

In a first aspect, an embodiment of the present invention provides a bendable puncture device, comprising a puncture head and a bendable sleeve assembly sleeved with the puncture head; the puncture head is used to puncture a tissue; The distal end of the bending sleeve assembly is provided with an adjustable bending section, the distal end of the puncture head is exposed outside the adjustable bending section, and the proximal end of the puncturing head is fixed to the distal end of the adjustable bending section above; the bendable sleeve assembly includes a tube body with a bendable function, and the bendable puncture device further includes a traction member disposed in the tube body with an adjustable bend function, the traction member is The distal end is fixed on the puncture head or the bendable segment.

In a second aspect, an embodiment of the present invention provides a puncture system, including a control handle and the above-mentioned bendable puncture device, wherein the distal end of the control handle is connected to the proximal end of the bendable puncture device.

beneficial effect

In the adjustable puncture device and puncture system provided by the embodiments of the present invention, a traction member is provided in the flexible cannula assembly, and the distal end of the traction member is fixed on the puncture head or the adjustable curve of the flexible cannula assembly. Therefore, after the adjustable puncture device enters the patient’s body, the puncture head and the adjustable cannula assembly can be freely adjusted in direction through the traction element, so that the puncture head can be more accurately aligned with the target tissue to be punctured, thereby avoiding adjustable bending. The puncture device causes damage to the passage of the puncture operation in the body, and makes the puncture more accurate and fast.

Description of drawings

In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the following briefly introduces the accompanying drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only These are some embodiments of the present invention, and for those of ordinary skill in the art, other drawings can also be obtained from these drawings without any creative effort.

FIG. 1 is a schematic structural diagram of a puncture system provided by a first embodiment of the present invention.

FIG. 2 is a schematic structural diagram of part A of the adjustable puncture device of the puncture system in FIG. 1 .

FIG. 3 is a cross-sectional view of the flexible puncture device of the puncture system in FIG. 2 taken along the line III-III.

FIG. 4 is a cross-sectional view of the first embodiment of the puncture head and the bendable cannula assembly of the bendable puncture device in FIG. 2 along the radial direction of the bendable puncture device.

FIG. 5 is a cross-sectional view of the second embodiment of the puncture head and the bendable cannula assembly of the bendable puncture device in FIG. 2 along the radial direction of the bendable puncture device.

FIG. 6 is a cross-sectional view of the third embodiment of the puncture head and the bendable cannula assembly of the bendable puncture device in FIG. 2 along the radial direction of the bendable puncture device.

FIG. 7 is a cross-sectional view of the fourth embodiment of the puncture head and the bendable cannula assembly of the bendable puncture device in FIG. 2 along the radial direction of the bendable puncture device.

FIG. 8 is an exploded view of a partial structure of the puncturing system of FIG. 1 .

FIG. 9 is a cross-sectional view of a part of the structure of the puncture system in FIG. 1 .

Fig. 10 is an exploded view of a part of the structure of the puncture system provided by the second embodiment of the present invention.

11 is a cross-sectional view of the first embodiment of the puncture head and bendable cannula assembly of the bendable puncture device of the puncture system of FIG. 10 along the axial direction of the bendable puncture device.

FIG. 12 is a cross-sectional view of a second embodiment of the puncture head and bendable cannula assembly of the bendable puncture device of the puncture system of FIG. 10 along the axial direction of the bendable puncture device.

13 is a cross-sectional view of a third embodiment of the puncture head and bendable cannula assembly of the bendable puncture device of the puncture system of FIG. 10 along the axial direction of the bendable puncture device.

Fig. 14 is a cross-sectional view of the first embodiment of the puncture head and the deflectable cannula assembly of the deflectable puncture device in Fig. 11 along the radial direction of the deflectable puncture device.

Fig. 15 is a cross-sectional view of the second embodiment of the puncture head and the deflectable cannula assembly of the deflectable puncture device in Fig. 11 along the radial direction of the deflectable puncture device.

Fig. 16 is a cross-sectional view of the third embodiment of the puncture head and the deflectable cannula assembly of the deflectable puncture device in Fig. 11 along the radial direction of the deflectable puncture device.

Fig. 17 is a cross-sectional view of the fourth embodiment of the puncture head and the deflectable cannula assembly of the deflectable puncture device in Fig. 11 along the radial direction of the deflectable puncture device.

FIG. 18 is a cross-sectional view of a part of the structure of the puncture system in FIG. 10 .

Embodiments of the present invention

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, but not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

First of all, it should be noted that in the field of interventional medicine, the end of the instrument close to the operator is usually referred to as the proximal end (ie, the operating end), and the end of the instrument away from the operator is called the distal end (ie, the insertion end). Specifically, the distal end refers to the end of the instrument that can be freely inserted into the animal or human body. The proximal end refers to the end that is operated by a user or machine or used to connect other devices. Furthermore, 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 to be understood that the terminology in the description and claims of the present invention and the above-mentioned drawings is for the purpose of describing particular embodiments only, and is not intended to limit the present invention. The terms "first", "second" and the like in the description and claims of the present invention and the above drawings are used to distinguish different objects, rather than to describe a specific order. The singular forms "a" and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. The term "comprising" and any variations thereof are intended to cover non-exclusive inclusion. Furthermore, the present invention can be implemented in many different forms and is not limited to the embodiments described in this embodiment. The following specific embodiments are provided for the purpose of facilitating a clearer and more thorough understanding of the disclosure of the present invention, wherein the words indicating orientation, such as up, down, left and right, are only for the positions of the structures shown in the corresponding drawings.

Subsequent descriptions in the specification are preferred embodiments for implementing the present invention. However, the above description is for the purpose of illustrating the general principles of the present invention, and is not intended to limit the scope of the present invention. The scope of protection of the present invention should be determined by the appended claims.

Please refer to FIG. 1 , which is a schematic structural diagram of a puncture system 1000 according to an embodiment of the present invention. The puncture system 1000 includes a bendable puncture device 100 and a control handle 200 . The distal end of the control handle 200 is connected to the proximal end of the adjustable puncture device 100 . In some embodiments, the control handle 200 is connected to an external energy generator, and the energy generator is used to provide ablation energy for the puncture head of the adjustable puncture device 100 . In some embodiments, an external energy generator can be connected to the proximal end of the control handle 200 through the energy connector 300 . In some embodiments, the control handle 200 is also externally connected with a liquid supply pipeline 400, and the liquid supply pipeline 400 is used for delivering fluid. In some embodiments, a fluid supply line 400 with a valve may be externally connected to the proximal end of the control handle 200 .

Among them, the energy generator is used to generate ablation energy such as radio frequency, pulse or microwave. An energy generator, such as, but not limited to, one of a radio frequency generator, a pulse generator, a microwave generator, or any combination thereof. A valve 401 is provided at the proximal end of the liquid supply pipeline 400 . In this embodiment, the valve 401 may be a three-way valve. For example, the first interface of the three-way valve is connected to the control handle 200 through the liquid supply pipeline 400; the second interface of the three-way valve is connected to the syringe through another liquid supply pipeline; the third interface of the three-way valve is connected to the syringe through another liquid supply pipeline; Three ports can be reserved for spare. In some other embodiments, the valve 401 can also be a two-way valve or other multi-way valve. It should be noted that, the valve 401 can design the number of ports of the valve according to the requirements of the puncture operation, which is not specifically limited in the present invention.

It should be understood by those skilled in the art that FIG. 1 is only an example of the puncturing system 1000, and does not constitute a limitation to the puncturing system 1000. The puncturing system 1000 may include more or less components than those shown in FIG. 1, or a combination of certain These components, or different components, such as puncture system 1000 may also include a delivery device, a power source, and the like.

Please refer to FIG. 2 and FIG. 3 together. FIG. 2 is a schematic diagram of a part of the structure of the adjustable puncture device 100 , and FIG. 3 is a cross-sectional view of the adjustable puncture device 100 . The bendable puncture device 100 is a unidirectional bendable puncture device, a bidirectional bendable puncture device or a multi-directional bendable puncture device. In this embodiment, the bendable puncture device 100 is a one-way bendable puncture device.

The bendable puncture device 100 includes a puncture head 10 and a bendable cannula assembly 20 which is sleeved with the puncture head 10 . The puncture head 10 is used to puncture the tissue body. A bendable segment 201 is provided at the distal end of the bendable sleeve assembly 20 . The distal end of the puncture head 10 is exposed outside the adjustable bendable section 201 . The proximal end of the puncture head 10 is fixed on the distal end of the bendable section 201 . The bendable sleeve assembly 20 includes a tubular body with bendable function. The bendable puncture device 100 further includes a traction member 30 disposed in the tubular body with the adjustable bend function. The distal end of the traction member 30 is fixed on the puncture head 10 or the adjustable bendable segment 201 .

In this way, the adjustable bendable puncture device provided by the present invention is provided with a pulling member in the bendable sleeve assembly, and the distal end of the pulling member is fixed on the puncture head or the bendable section of the bendable sleeve assembly, Therefore, after the adjustable puncture device enters the patient's body, the puncture head and the adjustable cannula assembly can be driven by the traction member to freely adjust the direction, so that the puncture head can be more accurately aligned with the target tissue to be punctured (including but not limited to the atrial septum). In this way, the adjustable bendable puncture device can be prevented from causing damage to the passage of the puncture operation in the body, and the atrial septal puncture can be made more accurate and fast.

By disposing the puncture head 10 at the distal end of the flexible cannula assembly 20, the problem of causing damage to other tissues during the puncturing process can be avoided, and the outer diameter of the puncturing device can be reduced. In addition, by fixing the traction member 30 on the puncture head 10 or the bendable section 201 of the bendable sleeve assembly 20, the operation is simple and the fixing efficiency is high, and the structure of the bendable puncture device 100 is simplified so that the adjustable bendable puncture device 100 can be adjusted. The outer diameter of the curved piercing device 100 is smaller. Since the overall outer diameter of the adjustable bendable puncture device 100 is small, the atrial septal puncture is more accurate and fast, and the puncture time is saved, thereby improving the safety of the puncture operation. Since the traction member 30 can control the bendable segment 201 to bend or restore straightness, it can be realized that the bendable puncture device 100 can be freely bent after entering the patient's body, so as to facilitate the delivery of the puncture head 10 to the target tissue, and avoid the need for The bendable puncture device 100 can cause damage to the access for intracorporeal puncture procedures.

In some embodiments, the pulling member 30 is fixed on the outer axial surface 1011 of the proximal end of the puncture head 10 . In this way, by directly fixing the traction member 30 on the outer axial surface 1011 of the proximal end of the puncture head 10, the welding points between the traction member 30 and the puncture head 10 are increased, which is not only easy to operate, high fixing efficiency, but also simplified. The structure of the bendable puncture device makes the outer diameter of the bendable puncture device smaller. In this embodiment, the inside of the adjustable bendable segment 201 is concave to form the operation space 202 corresponding to the connection between the puncture head 10 and the pulling member 30 to prevent the adjustable bendable segment 201 from being formed at the connection between the puncture head 10 and the pulling member 30 . The convex hull affects the conveying performance and connection stability. In addition, the design of the operating space 202 reduces the thickness of the adjustable bendable section 201, so that the adjustable bendable section 201 can be quickly bent or restored to be straight, and the atrial septal puncture is more accurate and fast, saving the puncture time, and further The safety of puncture operation is improved.

In another embodiment, please refer to FIG. 1 , FIG. 3 , and FIGS. 4 to 7 together. FIGS. 4 to 7 show the first to fourth embodiments of the puncture head 10 and the bendable cannula assembly 20 . Cross-sectional view of an embodiment. The pulling member 30 is embedded in the puncture head 10 . Specifically, a groove 1012 is defined on the outer axial surface 1011 of the proximal end of the puncture head 10 . The pulling member 30 is fixedly embedded in the groove 1012 . In this way, the outer diameter of the adjustable puncture device 100 can be further reduced, so that the atrial septal puncture can be more accurate and rapid, the puncture time can be saved, and the safety of the puncture operation can be improved. In some other embodiments, the pulling member can also be fixed to the adjustable bending section through a connecting member, such as a steel ring.

The pulling member 30 is fixedly connected with the piercing head 10 by means including but not limited to welding. The pulling member 30 is used for pulling the adjustable bendable section 201 to bend or straighten, and has a certain strength. In this embodiment, the traction member 30 is a single-strand structure, and a multi-strand structure may also be used. The cross-sectional shape of the pulling member 30 may be various shapes such as a circle, which is not specifically limited herein. On the basis that the traction member 30 has a certain strength to realize the traction function, the radial section should be as small as possible. The pulling member 30 is a metal wire, that is, the pulling member 30 is made of a metal material. The metal material is, for example, but not limited to stainless steel, tungsten alloy, cobalt-chromium alloy, or nickel-titanium alloy, etc., and can also be made of a polymer with a certain strength, and its material is not specifically limited herein. In this embodiment, the traction member 30 is preferably a stainless steel wire.

The tube body with the bendable function includes a multi-layer tube body. The pulling member 30 is provided between the multi-layer pipe bodies. Specifically, the multi-layered tube body of the bendable sleeve assembly 20 includes an inner tube 21 , an outer sheath tube 23 and a braided mesh tube 22 arranged between the inner tube 21 and the outer sheath tube 23 , and the traction member 30 is arranged in the inner tube 21 and the braided mesh tube 22. The outer sleeve 23 , the braided mesh tube 22 and the inner tube 21 are connected by fusion. Between the braided mesh tube 22 and the inner tube 21 there is a channel for the pulling member 30 to pass through. Since the pulling member 30 is provided in the channel between the inner tube 21 and the braided mesh tube 22, the pulling member 30 can be pulled along the axial direction of the adjustable sleeve assembly 20, so that the pulling force at the proximal end of the pulling member 30 can be more and more It is concentratedly transmitted to the distal end of the traction member 30, thereby ensuring more accurate and rapid puncture. In addition, since the inner tube 21 is closer to the puncture head 10 , the distance between the traction member 30 and the puncture head 10 is shortened, so as to avoid excessive bending of the traction member 30 to affect the stability and reliability of the connection with the puncture head 10 .

It should be noted that the multi-layer pipe bodies with adjustable bend function of the bendable sleeve assembly 20 of the present invention are not limited to the above three pipe bodies, and the bendable sleeve assembly 20 can protect more or less The pipe body is not specifically limited in the present invention.

The hardness of the inner tube 21 is less than or equal to the hardness of the outer sheath tube 23 , so that the outer sheath tube 23 can support and protect the inner tube 21 . In this embodiment, the material of the adjustable bendable section of the outer sheath tube 23 includes, but is not limited to, a polyamide (polyamide; PA) material with a hardness less than or equal to 35 Shore hardness (D), and the braided mesh tube 22 is adjustable in The bending section 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. The adjustable sleeve assembly 20 also includes a support section 203 connected to the proximal end of the adjustable section 201 . The material of the support section 203 of the outer sheath tube includes, but is not limited to, PA material greater than or equal to 72D or polyether block polyamide (Polyether block polyamide). At least one of amide, Pebax) materials, or other suitable polymer materials.

Optionally, 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 braided mesh tube 22 and the inner tube 21, and ensuring that other components can be It is smoothly inserted into the inner tube 21 . In this embodiment, the outer axial surface of the inner tube 21 may be formed with a rough surface through an etching process.

Optionally, in order to ensure the transmission of the driving force of the proximal end of the adjustable bendable puncture device 100, and at the same time to ensure that it has a flexible function and a bending function, so as to avoid damage to the blood vessel, the length of the adjustable bendable segment 201 is 4cm to 5cm. , Of course, it can be adjusted according to the specific operation.

As shown in Figure 2 and Figure 4 to Figure 7. In this embodiment, a fluid channel 101 is formed between the puncture head 10 and the bendable sleeve assembly 20 . The fluid channel 101 includes at least one water outlet 103 . In one embodiment, the pulling member 30 is disposed in isolation from the at least one water outlet 103 . In other embodiments, a part of the pulling member 30 is exposed to at least one water outlet 103 . Therefore, the outer diameter of the distal end of the adjustable puncture device 100 is reduced, thereby making the atrial septal puncture more accurate and fast; it can also ensure the connection stability of the traction member 30 and reduce the blocking of the water outlet 103 .

In this embodiment, at least one water outlet 103 is close to the distal end of the puncture head 10 . The liquid supply pipeline 400 communicates with the fluid channel 101 . Fluid channel 101 is used to transport fluid. The fluid channel 101 can be used to deliver the contrast agent. Since the water outlet 103 is close to the distal end of the puncture head 10, the position of the puncture head 10 can be quickly and accurately positioned, thereby improving the safety of the puncture operation. In some other embodiments, the fluid channel 101 can also be used to transport fluids such as normal saline or medicaments.

Referring to FIG. 4 again, in the first embodiment, two fluid passages 101 are formed between the puncture head 10 and the adjustable bendable sleeve assembly 20 . The distal ends of the fluid channels 101 form two opposite water outlets 103 correspondingly. Both fluid channels 101 are arranged side by side with the puncture head 10 . The piercing head 10 has a flat structure. Each fluid channel 101 is substantially semi-cylindrical. The pulling member 30 is embedded on the puncture head 10 and is isolated from the two water outlets 103 . Specifically, the traction member 30 is disposed at the connection between the puncture head 10 and the adjustable cannula assembly 20, thereby reducing the outer diameter of the distal end of the adjustable puncture device 100, thereby making the atrial septal puncture more accurate and fast; The connection stability of the traction member 30 can be ensured, and the blocking of the water outlet 103 can be reduced.

Referring to FIG. 5 again, in the second embodiment, two fluid passages 101 are formed between the puncture head 10 and the adjustable bendable sleeve assembly 20 . The distal ends of the fluid channels 101 form two opposite water outlets 103 correspondingly. Both fluid channels 101 are arranged side by side with the puncture head 10 . The piercing head 10 is constructed as a double concave profile. In this way, the fluid channel 101 has a larger fluid accommodating space, can deliver more contrast agents, and increases the area of the water outlet 103 , thereby further improving the positioning effect of the puncture head 10 . The pulling member 30 is embedded on the puncture head 10 and is isolated from the two water outlets 103 . Specifically, the traction member 30 is disposed at the connection between the puncture head 10 and the adjustable cannula assembly 20, thereby reducing the outer diameter of the distal end of the adjustable puncture device 100, thereby making the atrial septal puncture more accurate and fast; The connection stability of the traction member 30 can be ensured, and the blocking of the water outlet 103 can be reduced.

Referring to FIG. 6 again, in the third embodiment, the distal ends of the fluid channels 101 are correspondingly formed with four water outlets 103 facing each other. Four fluid channels 101 are formed between the puncture head 10 and the adjustable bendable sleeve assembly 20 , which are opposite to each other. The four fluid channels 101 are arranged side by side with the puncture head 10 . The piercing head 10 is constructed as a prismatic structure. The piercing head 10 includes four corners. The shapes of the four corners are matched with the inner peripheral surface of the sleeve 43 to increase the contact area between the puncture head 10 and the bendable sleeve assembly 20, thereby improving the connection between the puncture head 10 and the bendable sleeve assembly 20 stability. In this way, based on the four water outlets 103 evenly distributed in the circumferential direction of the puncture head 10, the visual experience during use can be effectively improved, that is, the positions of the water outlets 103 can be observed from different angles to quickly and accurately locate the puncture head 10 position. In addition, in the event that one of the water outlets 103 is blocked, the fluid can still flow out from the remaining water outlets 103, thereby reducing the risk of puncture surgery, and the fluid can be more uniformly transmitted to the patient's surgical site. The pulling member 30 is embedded on the puncture head 10 and exposed at one of the water outlets 103 . Specifically, the pulling member 30 is disposed at the position where the puncture head 10 is exposed to the water outlet 103 , so as to ensure the connection stability of the puncture head 10 and the bendable sleeve assembly 20 and at the same time reduce the distance of the bendable puncture device 100 . The outer diameter of the end, thereby making the atrial septal puncture more accurate and fast.

Referring to FIG. 7 again, in the fourth embodiment, a fluid channel 101 is formed between the puncture head 10 and the bendable sleeve assembly 20 . The distal end of the fluid channel 101 forms a correspondingly opposite water outlet 103 . The fluid channel 101 is arranged side by side with the piercing head 10 . The piercing head 10 is constructed as a semi-cylindrical structure. In this way, the fluid channel 101 can deliver more contrast agent, and the area of the water outlet 103 is increased to avoid clogging of the water outlet 103 , which also greatly improves the positioning effect of the puncture head 10 . The pulling member 30 is embedded on the puncture head 10 and is isolated from a water outlet 103 . Specifically, the traction member 30 is disposed at the connection between the puncture head 10 and the adjustable cannula assembly 20, thereby reducing the outer diameter of the distal end of the adjustable puncture device 100, thereby making the atrial septal puncture more accurate and fast; The connection stability of the traction member 30 can be ensured, and the blocking of the water outlet 103 can be reduced.

2 and 3 again, the distal end of the puncture head 10 forms a closed flexible tip 11, and the flexible tip 11 is configured as a smooth transition structure. In this way, the puncture head 10 can avoid scratching the non-puncture site of the operator or the patient during the puncture operation. The puncture head 10 has a cavity 12 along the axial direction, and the distal end of the cavity 12 is filled with the developing block 13 . In some embodiments, the imaging block 13 is near the distal end of the puncture head 10 . In this way, the position of the puncture head 10 can be further positioned during the puncture operation, so as to further improve the positioning effect of the puncture head 10 . 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 bendable puncture device 100 further includes an electrical guide wire 14 disposed in the bendable cannula assembly 20 . The distal end of the guide wire 14 is electrically connected to the puncture tip 10 . The proximal end of the conductance wire 14 is connected to an external energy generator through an energy connector 300 . Specifically, the proximal end of the cavity 12 is plugged with the electrical guide wire 14 . The conductive wire 14 can be fixedly connected to the inner axial surface 1013 of the puncture head 10 (ie, the inner wall of the cavity 12 ) by welding or crimping. The extending direction of the cavity 12 is parallel to the axial direction of the puncture head 10 to ensure good contact performance between the conductive wire 14 and the puncture head 10 . Preferably, the outer diameter of the conductive wire 14 is slightly smaller than the inner diameter of the cavity 12 of the puncture head 10 , so that the outer peripheral wall of the conductive wire 14 fits better with the inner peripheral wall of the cavity 12 of the puncture head 10 . The conductive wire 14 may include a non-insulated segment inserted into the puncture head 10 and an insulating segment inserted into the adjustable bendable sleeve assembly 20 . An insulating coating is applied on top or the conductive wire 14 is provided with an insulating sleeve on the outer casing of the conductive wire 14 .

A control handle 200 is externally connected to the proximal end of the adjustable bendable sleeve assembly 20 . The proximal end of the pulling member 30 is fixed to the control handle 200 . The control handle 200 is used to control the movement of the retractor 30 toward the proximal end or the distal end of the control handle 200, so that the adjustable bendable section 201 is bent or straightened in at least one direction, so as to facilitate the delivery of the puncture head 10 to the target tissue, and It can also avoid damage to the passage of the puncture operation in the body caused by the flexible puncture device 100, so that the puncture operation is more accurate and fast.

Please refer to FIG. 1 and FIGS. 8 to 9 together. The control handle 200 includes a housing 50 and a bending assembly 60 disposed on the housing 50 . The bending assembly 60 includes a main shaft 61 , an adjusting member 62 and a bending sliding member 63 . In this embodiment, the adjusting member 62 may be configured as a knob. In other embodiments, the adjustment member 62 may also be configured as an adjustment button or the like. The adjusting member 62 rotates along the central axis P1 of the adjusting member 62 relative to at least one of the main shaft 61 and the housing 50 . The bending sliding member 63 is movably disposed in the adjusting member 62, the proximal end of the adjustable bending sleeve assembly 20 is penetrated in the main shaft 61, and the pulling member 30 disposed in the adjustable bending sleeve assembly 20 extends from the adjustable bending sleeve assembly 20. The proximal end of the sleeve assembly 20 protrudes and is fixed on the bending sliding member 63 . The adjusting member 62 is used to drive the bending sliding member 63 to move toward the proximal end or the distal end of the control handle 200 , so that the adjustable bending section 201 is bent or straightened in at least one direction.

In this embodiment, the casing 50 includes a first casing 51 and a second casing 52 that are fixed to each other. The first casing 51 and the second casing 52 together form a receiving space 501 . The proximal end portion of the main shaft 61 is accommodated in the accommodating space 501 . The first casing 51 and the second casing 52 can be detachably connected together through a mounting structure. The installation structure includes, but is not limited to, a snap-fit structure, a sliding guide structure, a magnetic adsorption structure, an internal and external thread structure, a latch structure, and the like. In some embodiments, the first casing 51 and the second casing 52 may also be integrally formed.

Optionally, the main shaft 61 , the adjusting member 62 and the housing 50 are jointly enclosed to form a limiting space 502 , and the bending sliding member 63 moves in the limiting space 502 . Specifically, a first limit step 503 is formed at the connection between the adjustment member 62 and the main shaft 61 , a second limit step 504 is formed at the connection between the adjustment member 62 and the housing 50 , the first limit step 503 and the second limit step 504 is used to stop with the bending sliding member 63 to limit the bending sliding member 63 to move within the limiting space 502 . In this way, it can be ensured that the adjusting member 62 and the bending sliding member 63 are always in a cooperative connection, so that the adjusting member 62 drives the bending sliding member 63 to move and pulls the traction member 30 to move toward the proximal end or the distal end of the control handle 200 . In addition, the design of the first limiting step 503 and the second limiting step 504 can also limit the axial movement range of the bending sliding member 63, so as to avoid excessive bending of the adjustable bending section 201 to affect its performance.

The main shaft 61 includes a snap joint 611 and a guide cylinder 612 extending from the proximal end of the snap joint 611 along the central axis P1 of the main shaft 61 . The adjustable bending sleeve assembly 20 is sequentially inserted into the clamping joint 611 and the guide cylinder 612 , the bending sliding member 63 is movably sleeved outside the guiding cylinder 612 , and the adjusting member 62 is sandwiched between the clamping joint 611 and the casing 50 . .

In the present embodiment, the adjusting member 62 is configured as a cylindrical drum. An anti-skid structure 6201 is provided on the outer circumferential surface of the adjusting member 62 , so as to facilitate the user to rotate the adjusting member 62 and improve the user experience. The adjusting member 62 rotates relative to the main shaft 61 and the housing 50 along the central axis P1 of the adjusting member 62 , that is, the two ends of the adjusting member 62 are respectively connected to the main shaft 61 and the housing by rotation. Specifically, opposite ends of the adjusting member 62 are respectively provided with a first rotating connecting member 621 and a second rotating connecting member 622 . The distal end of the housing 50 is provided with a first connecting seat 53 rotatably connected with the first rotating connecting piece 621 , and the proximal end of the snap joint 611 is provided with a second connecting seat 6111 rotatably connecting with the second rotating connecting piece 622 .

Specifically, one of the first rotating connecting member 621 and the first connecting seat 53 is configured as a groove, and the other one of the first rotating connecting member 621 and the first connecting seat 53 is configured to be rotatably connected with the groove the bulge. One of the second rotating connecting piece 622 and the second connecting seat 6111 is configured as a groove, and the other one of the second rotating connecting piece 622 and the second connecting seat 6111 is configured as a protrusion rotatably connected with the groove . In this embodiment, the first rotating connecting member 621 is configured as a protrusion, and the first connecting seat 53 is provided with a groove that is rotatably matched with the protrusion. The second rotating connecting piece 622 is configured as a groove, and the second connecting seat 6111 is provided with a protrusion that is rotatably matched with the groove. It should be noted that, the adjusting member 62 may also be rotationally connected with the main shaft 61 and the housing 50 by other means, which is not specifically limited in the present invention.

The bending sliding member 63 includes a bending sliding block 631 that is rotatably matched with the adjusting member 62 . The bending slider 631 is configured as a threaded sleeve with an external thread 6311, and the adjusting member 62 is configured as a rotary cylinder with an internal thread 6202 and is screwed with the external thread 6311 of the threaded sleeve. In some embodiments, the pulling member 30 passes through the adjustable-bendable sleeve assembly 20 and the guide cylinder 612 in sequence and is fixedly disposed on the inner axial surface of the threaded sleeve.

In the present embodiment, a guide groove 614 is provided on the guide cylinder 612 along the axial direction, and the bending sliding member 63 further includes a guiding sliding block 632 arranged on the bending adjusting sliding block 631 and matched with the guiding 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 adjusting member 62 is rotated to drive the bending slider 631 to move axially relative to the adjusting member 62 , and the guide slider 632 moves along the guide groove 614 to control the pulling member 30 toward the control handle 200 proximal or distal movement.

The pulling member 30 includes at least one drawing wire, and the number of the bending sliding members 63 corresponds to the number of the at least one drawing wire. In this embodiment, the pulling member 30 includes a wire. The bendable puncture device 100 can bend the bendable segment 201 in a predetermined direction by pulling a single wire. The preset direction refers to the direction in which the adjustable bendable section 201 is bent toward the side close to the wire drawing. In some embodiments, the number of drawing wires may be multiple, and the bendable puncture device 100 may bend the adjustable bendable segment 201 toward multiple preset directions by pulling the multiple drawing wires.

The control handle 200 also includes a support tube 64 fixedly arranged in the main shaft 61 . The distal end of the support tube 64 is fixedly connected to the proximal end of the flexible cannula assembly 20 and is used to wrap the proximal end of the electrical guide wire 14 . The support tube 64 is used for supporting and protecting the electrical guide wire 14 , so as to ensure good contact performance between the electrical guide 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 sleeve assembly 20, thereby avoiding the problem of bending or breaking of the adjustable sleeve assembly 20 near the exit position of the pulling member 30, thereby preventing This ensures the smooth realization of the bending function of the adjustable bending sleeve assembly 20 .

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

The distal end of the main shaft 61 defines an opening 6101 which is clamped with the adjustable bendable sleeve assembly 20 . The proximal end of the main shaft 61 defines a receiving space 6102 along the axis to receive the support tube 64 and communicate with the opening 6101 . The adjustable-bend sleeve assembly 20 includes a connecting portion 204 that passes through the main shaft 61 and is exposed in the receiving space 6102 . The connection length L1 between the support tube 64 and the bendable sleeve assembly 20 is less than or equal to the axial length L2 of the connection portion 204 . Preferably, the connecting length L1 between the support tube 64 and the adjustable sleeve assembly 20 is equal to the axial length L2 of the connecting portion 204, so as to ensure that the proximal end of the adjustable sleeve assembly 20 has sufficient radial and axial directions supportive.

A holding portion 616 for holding the support tube 64 is also provided inside the guide cylinder 612 to ensure the stability of the connection between the support tube 64 and the bendable sleeve assembly 20 . The support tube 64 is made of a rigid material, such as steel pipe. The control handle 200 also includes a locking member 65 for locking the proximal end of the conductance wire 14 and/or the support tube 64 . Positions of the first casing 51 and the second casing 52 corresponding to the locking member 65 form a locking groove 505 for holding the locking member 65 . In addition, the locking member 65 can also be used to connect the liquid supply pipeline 400 through the tail end, and to connect the electrical guide wire 14 to the external energy generator of the energy connector 300 through the tail end. In this embodiment, please refer to FIG. 1 to FIG. 9 again. The operation method of the puncture system 1000 in this embodiment is as follows: after the delivery catheter is introduced into the body through percutaneous puncture, the bendable puncture device 100 is inserted into the body along the delivery catheter, The position of the puncture head 10 is determined by observing the developing point. After the puncture head 10 is close to the target position (eg atrial septal tissue), the puncture device 100 can be adjusted by controlling the handle 200 until the puncture head 10 is aligned with the target puncture position. Specifically, when the adjustable bending section 201 is in a straight state, when the adjusting member 62 is rotated leftward, the bending sliding member 63 moves toward the proximal end of the control handle 200, because the two ends of the pulling member 30 are respectively fixedly connected to the puncture head 10. and the bending slider 63, therefore, when the bending slider 63 gradually moves toward the proximal end of the control handle 200 with the pulling member 30, the pulling force of the pulling member 30 will gradually increase and drive the puncture head 10 to bend toward the proximal end , as the displacement of the traction member 30 increases gradually, the bending degree of the adjustable bending section 201 also increases gradually. When the adjusting member 62 is rotated to the right, the bending sliding member 63 moves toward the distal end of the control handle 200. Since the two ends of the pulling member 30 are fixedly connected to the puncture head 10 and the bending sliding member 63, respectively, when the bending sliding member 63 When the pulling member 30 is driven to move toward the distal end of the control handle 200 , the pulling force of the pulling member 30 is gradually reduced and the puncture head 10 is driven to gradually restore the straightness. When the pulling member 30 finishes pulling the pulling force, the puncture head 10 returns 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 and puncture, and the adjustable puncture device 100 is slowly and uniformly pushed forward until the developing point passes through the atrial septum and reaches the left atrium. The radio frequency connection of the energy generator is disconnected, and the entire flexible puncture device 100 is withdrawn to realize the puncture process of the atrial septal tissue.

The bendable puncture device provided by the present invention is provided with a traction member in the bendable sleeve assembly, and the distal end of the puller is fixed on the puncture head or the bendable section of the bendable sleeve assembly, so it can be After the adjustable puncture device enters the patient's body, the puncture head and the adjustable cannula assembly can be driven to adjust the direction freely by the traction member, so that the puncture head can be more accurately aligned with the target tissue to be punctured, thereby avoiding the adjustable puncture device to puncture the body. The surgical access causes damage and makes the atrial septal puncture more precise and faster.

Please refer to FIG. 1 and FIG. 10 to FIG. 11 together. 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 puncturing system 2000 is different from the puncturing system 1000 in the first embodiment.

The structure of the puncture system 2000 in the second embodiment is similar to that of the puncture system 1000 in the first embodiment, the difference is that the traction member 30 includes a first drawing wire 31 and a second drawing wire 32 . The bending sliding member 63 includes a first bending sliding member 63A and a second bending sliding member 63B. The distal ends of the first drawing wire 31 and the second drawing wire 32 are both fixed on the puncture head 10 or the bendable section 201 . The proximal end of the first drawing wire 31 is fixed on the first bending adjustment sliding member 63A, the proximal end of the second pulling wire 32 is fixed on the second bending adjustment sliding member 63B, the first bending adjustment sliding member 63A and the second bending adjustment sliding member 63A. 63B moves in the opposite direction. The first drawing wires 31 and the second drawing wires 32 are symmetrically distributed from the central axis of the puncture head 10. In other embodiments, the first drawing wires 31 and the second drawing wires 32 can also be distributed asymmetrically from the central axis of the puncturing head 10, so as to achieve The bendable section 201 is bent in different preset directions.

Please refer to FIGS. 11 to 12 together. FIGS. 11 to 12 show the puncture head 10 and the bendable cannula assembly 20 of the bendable puncture device 100 of the puncture system 2000 along the axial direction of the bendable puncture device 100 Cross-sectional views of different embodiments. As shown in FIG. 11 , in the first embodiment, the distal ends of the first drawing wire 31 and the second drawing wire 32 are both fixed on the puncture head 10 . The first drawing wire 31 and the second drawing wire 32 are welded to the outer axial surface 1011 of the puncture head 10 . Since the first drawing wire 31 and the second drawing wire 32 are directly welded to the outer axial surface 1011 of the puncture head 10, the operation is simple and the fixing efficiency is high, and the structure of the adjustable puncture device 100 is simplified, so that the adjustable puncture The outer diameter of the device 100 is relatively small, thereby enabling more precise and faster transseptal puncture.

As shown in FIG. 12 , in the second embodiment, two opposite grooves 1012 are defined on the outer axial surface 1011 of the proximal end of the puncture head 10 . The first drawing wire 31 and the second drawing wire 32 are respectively fixedly embedded in the two grooves 1012 . In this way, the outer diameter of the proximal end of the bendable puncture device 100 can be further reduced, so that the atrial septal puncture can be more accurate and fast, thereby saving the puncture time and improving the safety of the puncture operation.

As shown in FIG. 13 , in the third embodiment, the distal ends of the first drawing wire 31 and the second drawing wire 32 are fixed on the inner wall of the adjustable bending section 201 through the connecting piece 40 . Specifically, the distal ends of the first drawing wire 31 and the second drawing wire 32 are fixed on the inner wall of the adjustable bendable section 201 of the outer sheath tube 21 through the connector 40 and are disposed adjacent to the puncture head 10 . The connecting member 40 is substantially annular. The connector 40 is made of rigid material. In one embodiment, the connector 40 is a steel ring, and the inner wall of the outer sheath tube 21 is provided with a receiving groove for accommodating the steel ring, so as to avoid the bulging problem caused by inserting the steel ring into the adjustable sleeve assembly 20 .

Please refer to FIGS. 14 to 17 together. FIGS. 14 to 17 show the puncture head 10 and the bendable cannula assembly 20 of the bendable puncture device 100 of the puncture system 2000 along the direction of the bendable puncture device 100 . Cross-sectional views of different embodiments in the radial direction. As shown in FIGS. 14 and 15 , two fluid passages 101 are formed between the puncture head 10 and the flexible cannula assembly 20 . Both the first drawing wire 31 and the second drawing wire 32 are embedded on the puncture head 10, thereby reducing the outer diameter of the distal end of the adjustable puncture device 100, thereby making the atrial septal puncture more accurate and fast; and the first drawing wire 31 and the The second drawing wires 32 are isolated from the two fluid passages 101 to prevent the water outlet 103 from being blocked by the first drawing wires 31 and the second drawing wires 32 and affecting the flow of the fluid to the position to be punctured. As shown in FIG. 15 , the puncture head 10 is configured as a double concave molding structure. In this way, the fluid channel 101 has a larger fluid accommodating space, can deliver more contrast agents, and increases the area of the water outlet 103 , thereby further improving the positioning effect of the puncture head 10 .

As shown in FIG. 16 , four fluid channels 101 are formed between the puncture head 10 and the bendable sleeve assembly 20 , and each fluid channel 101 includes a water outlet 103 . Parts of the first drawing wire 31 and the second drawing wire 32 are exposed to at least one water outlet 103 . Specifically, both the first drawing wire 31 and the second drawing wire 32 are partially embedded on the puncture head 10, thereby reducing the outer diameter of the distal end of the bendable puncture device 100, thereby making the interatrial puncture more accurate and fast. The first drawing wire 31 and the second drawing wire 32 are partially exposed in the corresponding fluid channel 101, so that the adjustable bending section 201 can freely adjust the bending direction under the pulling of the pulling member 30, and at the same time ensure the area of the water outlet 103 to It is avoided that the water outlet 103 is blocked by the first drawing wire 31 and the second drawing wire 32 to affect the flow of the fluid to the position to be punctured.

As shown in FIG. 17 , a fluid channel 101 is formed between the puncture head 10 and the bendable sleeve assembly 20 , and the fluid channel 101 includes a water outlet 103 . Parts of the first drawing wire 31 and the second drawing wire 32 are exposed to the water outlet 103 . Specifically, both the first drawing wire 31 and the second drawing wire 32 are partially embedded on the puncture head 10, thereby reducing the outer diameter of the distal end of the bendable puncture device 100, thereby making the interatrial puncture more accurate and fast. The first drawing wire 31 and the second drawing wire 32 are respectively partially exposed in the fluid channel 101, so that the adjustable bending section 201 can freely adjust the bending direction under the pulling of the pulling member 30, and at the same time ensure the area of the water outlet 103 to avoid The water outlet 103 is blocked by the first drawing wire 31 and the second drawing wire 32, which affects the flow of the fluid to the position to be punctured.

Please refer to FIG. 11 and FIG. 18 together, for a cross-sectional view of a partial structure of the puncture system 2000 in FIG. 18 . The first rotating connecting piece 621 and the second rotating connecting piece 622 of the adjusting member 62 are both configured as protrusions, and the first connecting seat 53 and the second connecting seat 6111 are grooves that are rotatably matched with the protrusions, that is, the first rotating The connecting piece 621 is rotatably inserted into the distal end of the housing 50 , and the second rotating connecting piece 622 is inserted into a groove formed around the guide cylinder 612 in the axial direction of the snap joint 611 .

A stop member 623 is also provided in the middle of the inner side wall of the adjusting member 62 . The stopper 623 divides the limiting space 502 into the mutually independent first limiting space 5021 and the second limiting space 5022, and stops the first bending sliding member 63A and the second bending sliding member 63B to prevent The first bending slider 63A is moved in the first limiting space 5021 , and the second bending slider 63B is moved in the second limiting space 5022 . The stopper 623 includes, but is not limited to, a non-threaded segment provided between the first limiting space 5021 and the second limiting space 5022, or a flange. The first limiting space 5021 and the second limiting space 5022 of the adjustment member 62 are provided with internal threads, and the inner diameter of the non-threaded section of the adjustment member 62 is smaller than or equal to the inner diameter of the threaded section of the adjustment member 62 .

The structures of the puncture head 10 , the bendable cannula 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 applicable to those in the second embodiment. The puncture head 10 , the bendable cannula assembly 20 , the traction member 30 , the control handle 200 , the energy generator and the liquid supply pipeline 400 of the puncture system 2000 will not be repeated in the present invention.

In this embodiment, please refer to FIGS. 11 to 18 again. The operation method of the puncture system 2000 in this embodiment is as follows: after the delivery catheter is introduced into the body through percutaneous puncture, the flexible puncture device 100 is inserted into the body along the delivery catheter, and the flexible puncture device 100 is inserted into the body along the delivery catheter. The position of the puncture head 10 is determined by observing the developing point. After the puncture head 10 is close to the target position (eg atrial septal tissue), the puncture device 100 can be adjusted by controlling the handle 200 until the puncture head 10 is aligned with the target puncture position. Specifically, when the adjustable bending section 201 is in a straight state, when the adjusting member 62 is rotated to the right, the first bending sliding member 63A moves towards the distal end of the control handle 200 , and the second bending sliding member 63B moves towards the control handle 200 The proximal end of the control handle 200 is moved, thereby driving the first drawing wire 31 to advance toward the distal end of the control handle 200, and driving the second drawing wire 32 to advance toward the proximal end of the control handle 200, so as to realize the bending of the adjustable bending section 201 in the first direction, wherein, The first direction is the direction in which the bendable section 201 is bent toward the side close to the second drawing wire 32 , that is, the direction in which the bendable section 201 is bent toward the side away from the first drawing wire 31 . When the adjustable bending section 201 is bent to the maximum bending angle, the first bending sliding member 63A stops with the first limiting step 503, and the second bending sliding member 63B stops with the second limiting step 504. That is, the first bending sliding member 63A moves to the most distal position of the first limiting space 5021 , and the second bending sliding member 63B moves to the most distal position of the second limiting space 5022 . When the adjustable bending section 201 is restored to be straight, the adjusting member 62 is rotated leftward. At this time, the first bending sliding member 63A moves toward the proximal direction of the control handle 200 , and the second bending sliding member 63B moves toward the distal end of the control handle 200 . Move in the end direction until the first bending member 63A and the second bending sliding member 63B move to the initial positions respectively, wherein the initial position means that the first bending sliding member 63A is located in the middle position of the first limiting space 5021 and the second position. The second bending sliding member 63B is located in the middle position of the second limiting space 5022 .

When the adjustable bending section 201 is in a straight state, when the adjusting member is rotated to the left, the first bending sliding member 63A moves towards the proximal end of the control handle 200, and the second bending sliding member 63B moves towards the distal end of the control handle 200, thereby Drive the first drawing wire 31 to advance toward the proximal end of the control handle 200, and drive the second drawing wire 32 to advance toward the distal end of the control handle 200, so as to realize the bending of the adjustable bending section 201 in the second direction, wherein the second direction is the same as the first direction. In the opposite direction. The second direction is the direction in which the adjustable bendable section 201 is bent toward the side close to the first drawing wire 31 , that is, the direction in which the bendable section 201 is bent toward the side away from the second drawing wire 32 . When the adjustable bending section 201 is adjusted to the maximum bending angle, the first bending sliding member 63A stops with the stop member 623, and the second bending sliding member 63B stops with the stopping member 623, that is, the first adjustment sliding member 63A stops with the stop member 623. The bending sliding member 63A moves to the most distal position of the first limiting space 5021 , and the second bending sliding member 63B moves to the most distal position of the second limiting space 5022 . When the adjustable bending section 201 is restored to be straight, the adjusting member 62 is rotated to the right. At this time, the first bending sliding member 63A moves towards the distal end of the control handle 200, and the second bending sliding member 63B moves towards the distal end of the control handle 200. Move in the proximal direction until the first bending member 63A and the second bending sliding member 63B respectively move to the initial positions, wherein the initial position means that the first bending sliding member 63A is located in the middle position of the first limiting space 5021 and The second bending sliding member 63B is located in the middle position of the second limiting space 5022 .

When the puncture head 10 is aligned with the target puncture position, the energy connector 300 is connected to the external energy generator to start ablation and puncture, and the adjustable puncture device 100 is slowly and uniformly pushed forward until the developing point passes through the atrial septum and reaches the left atrium. The radio frequency connection of the energy generator is disconnected, and the entire flexible puncture device 100 is withdrawn to realize the puncture process of the atrial septal tissue.

The bendable puncture device provided by the present invention is provided with a traction member in the bendable sleeve assembly, and the distal end of the puller is fixed on the puncture head or the bendable section of the bendable sleeve assembly, so it can be After the adjustable puncture device enters the patient's body, the puncture head and the adjustable cannula assembly can be driven to adjust the direction freely by the traction member, so that the puncture head can be more accurately aligned with the target tissue to be punctured, thereby avoiding the adjustable puncture device to puncture the body. The surgical access causes damage and makes the atrial septal puncture more precise and faster. In addition, by arranging the first bending sliding member and the second bending member on the control handle, the adjustable bending section can be bent in two different directions through the left-handed or right-handed adjustment member, so that it can be flexibly adjusted during the puncture operation. The direction of the puncture device can be adjusted to make the puncture operation more precise and fast.

It should be noted that the above-mentioned bending assembly 60 for controlling the movement of the traction member 30 toward the proximal end or the distal end of the control handle 200 may, in other embodiments, also include a slider, which is realized by the axial movement of the slider, etc. The control pulling member 30 moves toward the proximal end or the distal end of the control handle 200, and the present invention does not specifically limit the implementation manner.

The embodiments of the present invention are described above in detail, and specific examples are used to illustrate the principles and implementations of the present invention. The descriptions of the above embodiments are only used to help understand the method and the core idea of the present invention; at the same time, for Persons of ordinary skill in the art, according to the idea of the present invention, will have changes in the specific embodiments and application scope. To sum up, the content of this description should not be construed as a limitation of the present invention.

Claims (22)

1. An adjustable puncture device, 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 bendable sleeve assembly The distal end of the puncture head is provided with an adjustable bendable segment, the distal end of the puncture head 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 bend-adjustable sleeve assembly includes a tube body with an adjustable bend function, and the bendable puncture device further includes a traction member arranged in the tube body with an adjustable bend function, and the distal end of the traction member is fixed to the on the puncture head or the adjustable bendable segment.
2. The adjustable bendable puncture device according to claim 1, wherein the traction member is fixed on the outer axial surface of the proximal end of the puncture head; or, the outer axial surface of the proximal end of the puncture head is The surface is provided with a groove, and the traction member is fixedly embedded in the groove.
3. The bendable puncture device according to claim 1 or 2, wherein the tube body with the bendable function comprises a multi-layer tube body, and the multi-layer tube body comprises an inner tube, an outer sheath tube and a set of 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 bendable puncture device 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 disposed adjacent to the puncture head.
5. The adjustable-bend puncture device according to claim 4, wherein the connecting member is a steel ring, and a receiving groove for receiving the steel ring is defined on the inner wall of the outer sheath tube.
6. The bendable puncture device according to any one of claims 3 to 5, wherein the material of the bendable section of the outer sheath tube comprises a PA material with a hardness less than or equal to 35D, and the braided mesh tube is The bendable section is woven from stainless steel wire, and the material of the bendable section of the inner tube includes PTFE material.
7. The adjustable-bend puncture device according to any one of claims 1 to 6, wherein the length of the adjustable-bend segment is 4 cm~5cm.
8. The bendable puncture device according to any one of claims 1 to 7, wherein a control handle is externally connected to the proximal end of the bendable sleeve assembly, and the proximal end of the traction member is fixed to the control handle, The control handle is used to control the traction member to move 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-bend puncture device according to claim 8, wherein the control handle comprises a casing and a bending-adjusting assembly provided on the casing, the bending-adjusting assembly comprising a main shaft, an adjusting member and a bending-adjusting assembly a sliding member, the regulating member rotates along the central axis of the regulating member relative to at least one of the main shaft and the housing, the bending sliding member is movably arranged in the regulating member, and the adjustable The proximal end of the bendable sleeve assembly is passed through the main shaft, and the traction member disposed in the bendable sleeve assembly protrudes from the proximal end of the bendable sleeve assembly and is fixed to the On the bending sliding member, the regulating member 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 restored to be straight in at least one direction, The main shaft, the adjusting member and the casing are jointly formed to form a limiting space, and the bending sliding member moves in the limiting space.
10. The adjustable-bend puncture device 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-bendable sleeve The components are successively passed through the clip joint and the guide cylinder, the bending sliding member is movably sleeved outside the guide cylinder, and the adjustment member is sandwiched between the clip joint and the housing. between.
11. The adjustable bending puncture device according to claim 10, wherein the bending adjustment sliding member comprises a bending adjustment sliding block rotatably matched with the adjustment member, and the bending adjustment sliding block is configured as a thread having an external thread The adjusting member is configured as a rotary cylinder with an internal thread and is screwed with the external thread of the threaded sleeve, and the pulling member passes through the adjustable bending 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-bend puncture device according to claim 11, wherein a guide groove is provided on the guide cylinder in the axial direction, and the bending-adjusting sliding member further comprises a bending-adjusting sliding member disposed on the bending-adjusting sliding block and connected to the A guide block matched with a guide groove, the guide block is provided with a fixing hole, the traction member is fixed in the fixing hole, and the adjusting member is rotated to drive the bending sliding block relative to the adjusting member 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 bending puncture device according to claim 9, wherein the pulling member comprises at least one drawing wire, and the number of the bending sliding member corresponds to the number of the at least one drawing wire.
14. The adjustable bending puncture device 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 bending sliding member 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 sliding member On the other hand, the proximal end of the second wire drawing is fixed on the second bending sliding member, the first bending sliding member and the second bending sliding member move in opposite directions, and the first wire drawing and the second bending sliding member move in opposite directions. The second drawing wires are symmetrically distributed from the central axis of the puncture head.
15. The adjustable puncture device 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 of the 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 device according to any one of claims 9 to 15, characterized in that, the bendable puncture device further comprises an electrical guide wire arranged in the bendable cannula assembly, the electrical guide wire The distal end of the puncture head is electrically connected to the puncture head, 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 on the proximal end of the bendable sleeve assembly and used to wrap the proximal end of the electrical guide wire.
17. The bendable puncture device according to claim 16, wherein the distal end of the support tube is inserted into the proximal end of the bendable sleeve assembly, and the proximal end of the bendable sleeve assembly is inserted into the proximal end of the bendable sleeve assembly. The end is provided with a sheathing point for the pulling 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 support The length of the axial connection between the tube and the bendable sleeve assembly.
18. The adjustable-bend puncture device according to claim 16 or 17, wherein the distal end of the main shaft is provided with an opening which is clamped with the adjustable-bendable sleeve assembly, and the proximal end of the main shaft is along the axis 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 device according to any one of claims 16 to 18, 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 cavity is The proximal end is plugged into the conductive wire.
20. A puncture system, comprising a control handle and the adjustable puncture device according to any one of claims 1-19, wherein the distal end of the control handle is connected to the proximal end of the adjustable puncture device.
21. The puncture system according to claim 20, wherein an energy generator is externally connected to the control handle, and the energy generator is used to provide ablation energy for the puncture head.
22. The puncture system according to claim 20 or 21, wherein the control handle is connected to an external liquid supply pipeline, and the liquid supply pipeline is used for delivering fluid.