Atrial septum puncture device

Abstract

The invention relates to an atrial septum puncture device which comprises a puncture execution assembly and a puncture guide assembly. The puncture execution assembly comprises a puncture guide wire, a micro catheter and an expansion sheathing canal which are sequentially arranged from inside to outside, and a puncture control handle connected with the near ends of the puncture guide wire, the micro catheter and the expansion sheathing canal; the puncture guide wire is used for conducting primary electric puncture on the atrial septum, the micro catheter is used for positioning the far end of the puncture guide wire, and a puncture part is arranged at the far end of the expansion sheath tube and used for conducting secondary electric puncture on the atrial septum; the puncture guiding assembly comprises a bending adjusting sheath tube and a bending adjusting control handle, the bending adjusting control handle is used for controlling the bending angle of the bending adjusting sheath tube, the bending adjusting sheath tube is provided with a first cavity channel which is axially through, and the first cavity channel is used for allowing the expansion sheath tube to penetrate through.

Description

Technical Field

[0001] The present invention relates to the field of medical devices for cardiac surgery, and particularly to an atrial septum puncture device. Background Art

[0002] With the continuous innovation and development of minimally invasive cardiac surgery techniques, minimally invasive methods for treating left heart diseases through implantable devices, radiofrequency ablation, etc. have gradually become an important development direction in the medical field. Among many cardiac interventions, accessing the left atrium is recognized as a technical difficulty, and the method of reaching the left heart from the right heart through the oval fossa - atrial septum puncture has become the most commonly used approach to access the left heart clinically. Although atrial septum puncture seems like a minor operation, it provides a direct access to the left atrium for doctors, making many surgeries that were previously impossible through conventional routes possible and laying the foundation for subsequent minimally invasive treatments.

[0003] Currently, the commonly used atrial septum puncture methods in clinical practice mainly include mechanical puncture and radiofrequency puncture.

[0004] Mechanical atrial septum puncture instruments refer to pure mechanical design instruments without the participation of electronic components, which are the most commonly used traditional puncture methods in current clinical practice. However, mechanical puncture has obvious technical defects: when the puncture direction is incorrect or the force is too strong, it is easy to puncture the atrial free wall, causing serious complications such as atrial perforation and aortic injury; in addition, the mechanical damage to the endocardium during the puncture process may activate the coagulation system and increase the risk of thrombus formation.

[0005] Radiofrequency atrial septum puncture uses radiofrequency energy for puncture. Although it avoids some of the disadvantages of mechanical puncture, due to its structure limitations, there are still problems such as low accuracy at present. Summary of the Invention

[0006] The present invention discloses an atrial septum puncture device, aiming to solve the technical problems existing in the prior art.

[0007] The present invention adopts the following technical solutions:

[0008] The present invention provides an atrial septum puncture device, including a puncture execution assembly and a puncture guidance assembly;

[0009] The puncture execution assembly includes a puncture guide wire, a microcatheter, and an expansion sheath tube arranged in sequence from the inside out, and a puncture control handle connected to the proximal ends of the three; the puncture guide wire is used for performing a primary electrical puncture on the atrial septum, the microcatheter is used for positioning the distal end of the puncture guide wire, and the distal end of the expansion sheath tube is provided with a puncture portion for performing a secondary electrical puncture on the atrial septum;

[0010] The puncture guide assembly includes a bending sheath and a bending control handle. The bending control handle is used to control the bending angle of the bending sheath. The bending sheath is provided with an axially penetrating first lumen, and the first lumen is used to penetrate the expansion sheath.

[0011] As a preferred technical solution, the distal end of the puncture guidewire is provided with a puncture head, which is configured as a blunt head; the proximal end of the puncture guidewire is fixed to the puncture control handle and can be electrically connected to the power generating device.

[0012] As a preferred technical solution, a positioning ring is provided at the distal end of the microcatheter. The positioning ring is configured as an annular developing structure for determining the puncture position before puncture.

[0013] As a preferred technical solution, the puncture part includes an electrode tip arranged at the distal end of the expansion sheath, the electrode tip is connected to a wire embedded in the expansion sheath, the wire extends into the puncture control handle, and can be electrically connected to the power generating device.

[0014] As a preferred technical solution, the dilatation sheath further includes a pressure sensor, which is disposed on the proximal side of the electrode tip and is used to detect pressure changes during the puncture process and to control the power-on state of the electrode tip.

[0015] As an optimal technical solution, the puncture control handle includes a microcatheter control knob and a puncture guidewire control button. The microcatheter control knob is used to control the extension and retraction of the microcatheter, and the puncture guidewire control button is used to control the extension and retraction of the puncture guidewire, so that the puncture guidewire and the microcatheter can be operated independently.

[0016] As a preferred technical solution, the bending sheath is also provided with a second lumen, which is used to pass a stabilizing guide wire. The distal end of the stabilizing guide wire is used to contact the inner wall of the superior vena cava in the heart and buffer the displacement of the device caused by heart beating.

[0017] As a preferred technical solution, the stabilizing guide wire includes a contact segment and a support segment connected sequentially from the distal end to the proximal end, and the contact segment has a smaller elastic modulus or stiffness than the support segment; the contact segment is spiral-shaped, used to provide buffering and increase the contact area with the endocardium; the support segment is straight rod-shaped, used to provide supporting force.

[0018] As a preferred technical solution, the contact section is a multi-turn conical spiral structure, and the spiral diameter of the conical spiral structure gradually increases from the proximal end to the distal end.

[0019] As a preferred technical solution, a traction wire is passed through the inner wall of the bending adjustment sheath, the distal end of the traction wire is fixedly connected to the distal end of the bending adjustment sheath, and the proximal end of the traction wire is connected to the bending adjustment control handle.

[0020] As a preferred technical solution, the bending control handle includes a handle housing, a fixing tube, a bending knob, a bending drive member and a bending moving member;

[0021] The fixed tube is fixed inside the handle housing. The bending adjustment knob is connected to the bending driving member and sleeved outside the fixed tube. The bending driving member is threadedly connected to the bending moving member. The bending moving member is sleeved on the outer periphery of the fixed tube and connected to the proximal end of the traction wire. By rotating the bending adjustment knob, the bending moving member can be driven to axially move, thereby adjusting the tension of the traction wire and realizing the control of the bending angle of the distal end of the bending sheath tube.

[0022] The technical solution adopted by the present invention can achieve the following beneficial effects:

[0023] The present invention mainly provides an atrial septum puncture device, which includes a puncture execution component and a puncture guiding component. Through the combination of the two, the safety and success rate of atrial septum puncture can be significantly improved. Among them, the puncture execution component adopts a dual electrical puncture mechanism. When performing the puncture operation, a first electrical puncture is first performed by the puncture guide wire, and then a second electrical puncture is performed through the dilatation sheath. This progressive puncture method can reduce the risk of damage to cardiac tissue and improve the puncture accuracy at the same time; the puncture guiding component allows the physician to accurately adjust the puncture angle to adapt to the differences in the cardiac anatomical structures of different patients.

[0024] Furthermore, the microcatheter in this device is configured with a positioning ring structure, enabling the physician to clearly identify the puncture position through imaging means before puncture, avoiding complications caused by improper puncture positions; the pressure sensor integrated in the dilatation sheath can real-time monitor the pressure changes during the puncture process and control the energization state of the electrode tip accordingly. When it detects that the puncture is completed, the current is automatically cut off, effectively preventing electrical energy from damaging other cardiac tissues.

[0025] In addition, the present device also sets a stabilizing guide wire in the puncture guiding component. Its conical spiral contact section can form a firm contact with the endocardium, effectively offsetting the instrument shaking caused by cardiac pulsation and ensuring the stability and safety of the puncture process. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following will briefly introduce the drawings required for the description of the embodiments. These drawings form a part of the present invention. The schematic embodiments of the present invention and their descriptions explain the present invention and do not constitute an improper limitation to the present invention. In the drawings:

[0027] Figure 1 is a schematic structural diagram of an atrial septum puncture device in an embodiment disclosed by the present invention;

[0028] Figure 2 is a schematic diagram of the distal structure of an atrial septum puncture device in an embodiment disclosed by the present invention;

[0029] Figure 3Schematic diagram of the structure of a puncture guide wire in an implementation manner disclosed in an embodiment of the present invention;

[0030] Figure 4 Schematic diagram of the structure of a microcatheter in an implementation manner disclosed in an embodiment of the present invention;

[0031] Figure 5 Schematic diagram of the structure of a dilatation sheath in an implementation manner disclosed in an embodiment of the present invention;

[0032] Figure 6 Cross-sectional view of the distal end structure of a dilatation sheath in an implementation manner disclosed in an embodiment of the present invention;

[0033] Figure 7 Schematic diagram of the structure of a puncture control handle in an implementation manner disclosed in an embodiment of the present invention;

[0034] Figure 8 Schematic diagram of the structure of a bending adjustment sheath in an implementation manner disclosed in an embodiment of the present invention;

[0035] Figure 9 Schematic diagram of the structure of a stabilizing guide wire in an implementation manner disclosed in an embodiment of the present invention;

[0036] Figure 10 Schematic diagram of the structure of a bending adjustment control handle in an implementation manner disclosed in an embodiment of the present invention;

[0037] Figure 11 Cross-sectional view of a bending adjustment control handle in an implementation manner disclosed in an embodiment of the present invention;

[0038] Figure 12 Schematic diagram of the working state of a stabilizing guide wire in the heart in an implementation manner disclosed in an embodiment of the present invention.

[0039] Explanation of reference numerals:

[0040] Puncture guide wire 11, puncture head 111, microcatheter 12, positioning ring 121, dilatation sheath 13, electrode tip 131, pressure sensor 132, visualization ring 133, puncture control handle 14, microcatheter control knob 141, puncture guide wire control button 142, bending adjustment sheath 21, first channel 211, second channel 212, bending adjustment control handle 22, fixed tube 221, bending adjustment knob 222, bending adjustment driving member 223, bending adjustment moving member 224, stabilizing guide wire 31, contact section 311, support section 312. Detailed implementation manners

[0041] To make the objectives, technical solutions and advantages of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below in conjunction with specific embodiments of the present invention and the corresponding drawings. In the description of the present invention, it should be noted that the term "or" is generally used in the sense of including "and / or", unless otherwise explicitly specified in the context.

[0042] In the description of the present invention, it should be noted that unless otherwise clearly specified and limited, the terms "installed", "connected" and "coupled" should be understood in a broad sense. Additionally, in the description of this application, the terms "first", "second", etc. are only used for distinguishing descriptions and cannot be construed as indicating or implying relative importance. As used herein, the "proximal end" refers to the end closer to the operator along the length direction of the interatrial septum puncture device; the "distal end" is the end farther from the operator along the length direction of the interatrial septum puncture device.

[0043] Those skilled in the art can understand that, in order to achieve their respective functions and meet the requirements of surgical operations, the specific shapes / sizes / angles, etc. of each structure can be adaptively adjusted. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than 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 fall within the scope of protection of the present invention.

[0044] Reference Figure 1 、 Figure 2 To solve the problems existing in the prior art, an interatrial septum puncture device is provided in an embodiment of the present invention. The interatrial septum puncture device includes a puncture execution assembly and a puncture guidance assembly. Among them, the puncture execution assembly is used for electrically puncturing the interatrial septum, and the puncture guidance assembly can accurately adjust the puncture angle to adapt to different physiological and pathological structures.

[0045] In some embodiments, the puncture execution assembly includes a puncture guide wire 11, a microcatheter 12, and an expansion sheath 13 that are sequentially sleeved from the inside out, and a puncture control handle 14 connected to the proximal ends of the three. Among them, the distal end of the puncture guide wire 11 is used for performing a primary electrical puncture on the interatrial septum, the microcatheter 12 is used for positioning the distal end of the puncture guide wire 11, and the distal end of the expansion sheath 13 is provided with a puncture portion for performing a secondary electrical puncture on the interatrial septum.

[0046] In some embodiments, the puncture guiding assembly includes a bending sheath 21 and a bending control handle 22. The bending control handle 22 is used to control the bending angle of the bending sheath 21. The bending sheath 21 is provided with a first axially penetrating channel 211 for threading an expansion sheath 13. In some embodiments, the bending sheath 21 is further provided with a second channel 212. The second channel 212 has an inlet at the proximal end of the bending sheath 21 and an outlet at a position near the distal end of the bending sheath 21. The second channel 212 is used to thread a stabilizing guide wire 31. The distal end of the stabilizing guide wire 31 can contact the inner wall of the superior vena cava in the heart to buffer the device displacement caused by the heartbeat.

[0047] As Figure 2 , Figure 3 , in some embodiments, the puncture guide wire 11 is disposed in the cavity of the microcatheter 12. Its proximal end is fixed to the puncture control handle 14 and can be electrically connected to an electric energy generating device, which is a radiofrequency generator. The distal end of the puncture guide wire 11 is provided with a puncture head 111. The puncture head 111 extends out of the distal end of the microcatheter 12 and is configured to be blunt-shaped to ensure that the force can be smoothly transmitted during puncture and avoid unnecessary scratches on other parts of the endocardium. The puncture head 111 is preferably made of a metal material with good electrical conductivity and can achieve the function of electrical puncture after being connected to the radiofrequency generator at the proximal end. Compared with traditional mechanical puncture, electrical puncture can provide more precise control of the penetration force and can complete the puncture under lower mechanical pressure to reduce the risk of cardiac perforation.

[0048] In some embodiments, the diameter of the puncture guide wire 11 is relatively small, preferably 0.8 - 1 mm, so that when puncturing, if the puncture position is inappropriate, the position can be reselected for puncture, and at the same time, the risk of causing adverse complications is reduced.

[0049] As Figure 4 , in some embodiments, the microcatheter 12 is disposed in the cavity of the expansion sheath 13. The distal end is used to provide a stable puncture channel for the puncture guide wire 11, and the proximal end is fixed to the puncture control handle 14. The microcatheter 12 is preferably made of a medical polymer material with good flexibility and has appropriate elasticity and strength, and can smoothly advance in the human body lumen and is not easily twisted and deformed.

[0050] In some embodiments, the distal end of the microcatheter 12 is provided with an annular groove, and a positioning ring 121 is fixedly arranged in the annular groove. The positioning ring 121 is configured as an annular imaging structure, and its imaging material can be selected but is not limited to materials with good X-ray visibility such as platinum-iridium alloy and gold. The position of the microcatheter 12 in the heart cavity can be positioned through the positioning ring 121 to improve the accuracy of the puncture position.

[0051] In some embodiments, the distal end of the microcatheter 12 is further provided with a smooth chamfered structure to prevent the microcatheter 12 from scratching or puncturing the endocardial tissue when moving in the cardiac cavity, thereby improving safety during operation.

[0052] Specifically, before performing the puncture, the microcatheter 12 is first placed against the atrial septum to determine the puncture position, so as to meet the puncture position requirements of different transseptal puncture surgeries; through imaging equipment, the physician can clearly observe the position of the positioning ring 121 to ensure that the puncture point is located in the most ideal area of the atrial septum, thereby avoiding complications caused by improper puncture position.

[0053] In some embodiments, the microcatheter 12 has a clearance fit or a transition fit with the puncture guidewire 11. More preferably, the inner diameter of the microcatheter 12 is slightly larger than the outer diameter of the puncture guidewire 11, and the inner lumen is smooth to reduce the friction when the puncture guidewire 11 moves forward; at the same time, the microcatheter 12 has a clearance fit with the expansion sheath 13 to facilitate the free movement of the microcatheter 12 in the expansion sheath 13.

[0054] In some embodiments, the length of the microcatheter 12 is shorter than the length of the puncture guidewire 11 , ensuring that the puncture guidewire 11 can extend from the distal end of the microcatheter 12 and perform the electropuncture operation.

[0055] like Figure 5 、 Figure 6 In some embodiments, the expansion sheath 13 is inserted into the first lumen 211 of the bending sheath 21, and the proximal end is fixed in the puncture control handle 14. The distal puncture portion is used to perform a secondary atrial septal puncture and accurately expand the area of electropuncture, and can accurately expand the area of electropuncture; during operation, the puncture guide wire 11 first performs an initial precise small-area electropuncture, and then the puncture portion of the expansion sheath 13 performs a secondary puncture, which not only improves the safety of the puncture, but also ensures the appropriate size of the puncture channel, which is convenient for the passage of subsequent treatment equipment.

[0056] In some embodiments, the puncture portion includes an electrode tip 131 disposed at the distal end of the expansion sheath 13. The electrode tip 131 can be configured in a ring shape, which can effectively gather electrical energy to achieve precise puncture and facilitate the expansion of the puncture aperture; the electrode tip 131 is connected to a wire pre-buried in the expansion sheath 13, and the wire extends into the puncture control handle 14 and is connected to an electric energy generating device through a dedicated interface in the puncture control handle 14. In this embodiment, the electric energy generating device is a radio frequency generator.

[0057] In some embodiments, the distal end of the dilation sheath 13 is configured as a roughly conical structure, which, on the one hand, can provide ideal support and stability for the microcatheter 12, preventing the microcatheter 12 from deflecting or bouncing during cardiac beating, ensuring that it always remains in the predetermined puncture position; on the other hand, the conical structure can control the area of the RF energy transmission region, making the perforation diameter formed by the secondary electropuncture controllable and consistent, while limiting the release range of the RF energy to prevent energy diffusion from causing unexpected damage to surrounding tissues.

[0058] In some embodiments, a developing ring 133 is further provided at the distal end of the dilation sheath 13 for observing the position changes of the dilation sheath 13 in the right atrium, so that the physician can grasp the precise position of the dilation sheath 13 in real time, especially when approaching the atrial septum, and can provide an important position reference.

[0059] In some embodiments, a pressure sensor 132 is provided between the electrode tip 131 and the developing ring 133. The pressure sensor 132 is annular and embedded in the wall of the expansion sheath 13. It can detect pressure changes during the puncture process and control the power-on state of the electrode tip 131.

[0060] In some embodiments, the distal section of the dilatation sheath 13 can be pre-configured with different curvatures based on individual patient anatomy to accommodate the precise requirements of punctures at different locations. In clinical practice, physicians can select an appropriate pre-shaped dilatation sheath 13 based on the patient's cardiac structure and target puncture location, thereby improving the accuracy and safety of punctures. This is particularly applicable to patients with anatomical abnormalities or special puncture requirements, allowing the puncture actuator to flexibly respond to various clinical situations.

[0061] Specifically, when the electrode tip 131 of the dilatation sheath 13 passes through the atrial septum and enters the left atrium, the distal end of the dilatation sheath 13 will experience a process from obstruction to sudden resistance reduction. This process will cause the pressure sensor 132 to detect obvious pressure changes, which is specifically manifested as a gradual increase in pressure before puncture and a sudden drop in pressure at the moment of puncture. The pressure sensor 132 converts this change into an electrical signal, which is transmitted to the proximal end in real time through a data wire pre-buried in the wall of the dilatation sheath 13. The RF generator is equipped with a special signal processing circuit that can analyze the data from the pressure sensor 132 in real time. When a characteristic pressure drop signal is detected, indicating that the atrial septum has been penetrated, the signal processing circuit will immediately trigger the safety interlock mechanism and immediately send a power-off command to the RF output circuit to cut off the RF energy and prevent the electrode tip 131 from contacting the inner wall of the left atrium in a high-energy state, thereby reducing the risk of damage to the left endocardium.

[0062] In this embodiment, the specific model / specification of the pressure sensor 132 is no longer specifically limited, and those skilled in the art can make an adaptive selection according to needs.

[0063] like Figure 7 In some embodiments, the puncture control handle 14 includes a handle shell, a shell fixing portion, a microcatheter control knob 141 , a microcatheter control driving member, a microcatheter control moving member, and a puncture guidewire control button 142 .

[0064] In some embodiments, the housing fixing portion is axially fixed to the inside of the handle housing, the microcatheter control knob 141 is connected to the microcatheter control drive and is sleeved outside the housing fixing portion, the microcatheter control knob 141 is exposed at the distal end of the handle housing, the microcatheter control drive is threadedly connected to the microcatheter control movable member, the microcatheter control movable member is sleeved around the outer periphery of the housing fixing portion and is fixed to the proximal end of the microcatheter 12, so that the axial displacement of the microcatheter control movable member can be directly transmitted to the microcatheter 12. When the physician rotates the microcatheter control knob 141, the rotational motion is converted into axial motion of the microcatheter control movable member through the microcatheter control drive, thereby achieving precise telescopic control of the microcatheter 12.

[0065] In some embodiments, the puncture guidewire control button 142 is located in the middle of the handle housing, and the bottom of the puncture guidewire control button 142 is fixedly connected to the proximal end of the puncture guidewire 11, and is used to control the extension and retraction of the puncture guidewire 11, so that the puncture guidewire 11 and the microcatheter 12 can be operated independently; preferably, a limiter is provided between the puncture guidewire control button 142 and the handle housing to ensure that the distal end of the puncture guidewire 11 does not extend out of the microcatheter 12 during the operation, thereby avoiding scratching the endocardium. Optionally, the limiter is configured as a barb at the end of the puncture guidewire control button 142, and the handle housing is provided with a matching limiter groove. During the preoperative preparation stage, the hook piece is stuck in the limiting groove to form a mechanical lock. At this time, no matter how the physician pushes the puncture guide wire control button 142, the hook piece will conflict with the limiting groove to prevent the axial movement of the button, thereby effectively limiting the position of the puncture guide wire 11; when atrial septal puncture is required, the physician first needs to press the puncture guide wire control button 142 to disengage the hook piece from the limiting groove. At this time, the puncture guide wire control button 142 can achieve axial movement, and the physician can control the puncture guide wire 11 to move forward to complete the puncture operation.

[0066] For those skilled in the art, the implementation method of the limiting function is not limited to the aforementioned cooperation mechanism of the hook and the limiting groove. According to specific clinical needs, a variety of alternative solutions can be used to achieve the same limiting effect, and no examples will be given one by one in this embodiment.

[0067] Since the internal structure of the puncture control handle 14 is basically the same as the internal structure of the bending control handle 22, the accompanying drawings will not show its internal structure. Figure 11 The internal structure diagram of the bending control handle 22 is shown in FIG.

[0068] As Figure 8 , in some embodiments, both the first lumen 211 and the second lumen 212 of the deflectable sheath 21 extend axially. The first lumen 211 serves as the main channel, which has a larger diameter and a cross-sectional shape that is circular or oval. Its distal opening is located at the distal end face of the deflectable sheath 21, i.e., the very front end of the sheath, such that the dilatation sheath 13 can extend linearly from the front end of the deflectable sheath 21. The second lumen 212 serves as the auxiliary channel, whose cross-sectional area is smaller than that of the first lumen 211 and is configured with a circular cross-section. Its inner diameter is slightly larger than the outer diameter of the stabilizing guide wire 31 to ensure that the stabilizing guide wire 31 can move freely within the lumen without excessive wobbling.

[0069] In some embodiments, different from the first lumen 211, the distal opening of the second lumen 212 is provided on the distal side surface of the deflectable sheath 21 rather than the end face. When the stabilizing guide wire 31 extends out from the side opening, it will naturally form a path at an angle to the axis of the first lumen 211. Particularly when the distal end of the deflectable sheath 21 is deflected and reaches the atrial septum, the stabilizing guide wire 31 can contact the intracardiac structure at a different position from the dilatation sheath 13, i.e., the superior vena cava, providing an additional support point and buffer area for the entire system.

[0070] In some embodiments, a traction wire is threaded through the inner wall of the deflectable sheath 21. The distal end of the traction wire is fixedly connected to the distal end of the deflectable sheath 21, and the proximal end of the traction wire is connected to the deflection control handle 22. By adjusting the deflection control handle 22, the tension of the traction wire can be changed to achieve deflection control of the distal direction of the deflectable sheath 21.

[0071] Specifically, when the traction wire is subjected to a tensile force, due to its asymmetric position within the deflectable sheath 21, it will cause the deflectable sheath 21 to bend and deform, and the bending direction will always be towards the side where the traction wire is located. The greater the traction force, the greater the bending angle of the deflectable sheath 21.

[0072] In actual operation, the physician first adjusts the tension of the traction wire to form an appropriate bending shape of the deflectable sheath 21 to adapt to the patient's vascular anatomy, then sends the stabilizing guide wire 31 through the second lumen 212 to the target position to provide support and buffering, and finally pushes the dilatation sheath 13 through the first lumen 211 to reach the atrial septum position.

[0073] As Figure 9 , Figure 12, in some embodiments, the stable guide wire 31 includes a contact section 311 and a support section 312 connected in sequence from the distal end to the proximal end. Among them, the contact section 311 is the part that directly contacts the endocardium of the heart, and it has a smaller elastic modulus or stiffness than the support section 312. Preferably, it is made of nitinol alloy. Due to its shape memory property, superelasticity, and biocompatibility, it can provide a more gentle touch when contacting the endocardium, reduce mechanical stimulation to the fragile endocardium, and at the same time can be delivered in a straightened state and return to a preset shape after being released in the body.

[0074] In some embodiments, the contact section 311 is in a spiral shape, more preferably a multi-turn conical spiral structure, and the spiral diameter of the conical spiral structure gradually increases from the proximal end to the distal end. At this time, the conical spiral structure can provide an elastic buffer effect in three-dimensional space. When the heart beats and causes changes in the size of the heart cavity, the spiral structure can compress or extend like a spring, automatically adapting to the dynamic changes of the heart without applying excessive local pressure to the endocardium; secondly, the conical spiral structure significantly increases the contact area with the endocardium. Compared with a straight guide wire, a spiral of the same length can provide several times the contact area of a straight line, which can not only disperse the contact pressure but also improve the stability of the guide wire and reduce the risk of accidental dislocation.

[0075] In some embodiments, the support section 312 is in a straight rod structure, which is used to provide greater axial stiffness and pushing performance. Optionally, the support section 312 is made of stainless steel material, or the support section 312 has a larger diameter than the contact section 311 to provide better torsional controllability and pushing stability.

[0076] Such as Figure 10 , Figure 11 , in some embodiments, the bending control handle 22 includes a handle housing, a fixed tube 221, a bending knob 222, a bending driving member 223, and a bending moving member 224; the fixed tube 221 is fixed inside the handle housing, the bending knob 222 is connected to the bending driving member 223 and sleeved outside the fixed tube 221, the bending driving member 223 is threadedly connected to the bending moving member 224, and the bending moving member 224 is sleeved outside the fixed tube 221 and connected to the proximal end of the traction wire. By rotating the bending knob 222, the bending moving member 224 can be driven to move axially, thereby adjusting the tension of the traction wire and realizing the control of the bending angle of the distal end of the bending sheath tube 21.

[0077] In some embodiments, there are two cavities at the proximal end of the bending control handle 22. The smaller cavity is used to connect the three-way pipe, which is the entry position of the stable guide wire 31 and can evacuate the stable guide wire 31 channel; the larger cavity is located at the center of the proximal end of the handle and is directly connected to the first cavity 211 of the bending sheath tube 21 for placing the dilatation sheath 13.

[0078] In some embodiments, the linkage relationship among the handle housing, the fixed tube 221, the bending adjustment knob 222, the bending adjustment driving member 223, the bending adjustment moving member 224 and the traction wire in the bending adjustment control handle 22 is the same as the linkage relationship among the handle housing, the housing fixing portion, the microcatheter control knob 141, the microcatheter control driving member, the microcatheter control moving member and the microcatheter 12 in the puncture control handle 14. The only difference is that the axial movement of the bending adjustment moving member 224 is used to tighten or relax the tension of the traction wire, while the axial movement of the microcatheter control moving member is used to drive the axial movement of the microcatheter 12. Therefore, the internal structure diagram of the puncture control handle 14 will not be illustrated, and for details, please refer to the internal structure diagram of the bending adjustment control handle 22.

[0079] In some embodiments, the operation steps of the atrial septum puncture device are as follows:

[0080] The physician delivers the bending adjustment sheath tube 21 to the right atrium through the femoral vein via a conventional guiding sheath device, and then, via the bending adjustment control handle 22, completely inserts the puncture guide wire 11, the microcatheter 12 and the dilatation sheath tube 13 into the first lumen 211 of the bending adjustment sheath tube 21. Then, the stability guide wire 31 is inserted into the second lumen 212 of the bendable sheath tube 21. During the operation, the physician first rotates the bending adjustment knob 222 to control the bending angle of the bending adjustment sheath tube 21 and accurately position it at the atrial septum puncture position. Then, the physician advances the puncture guide wire 11 by pressing the puncture guide wire control button 142. At the same time, the microcatheter 12 extends from the front end of the bending adjustment sheath tube 21 and approaches the atrial septum. The physician rotates the microcatheter control knob 141 to advance the microcatheter 12 and position it at the ideal puncture point. The physician activates the radiofrequency generator to supply power to the puncture guide wire 11. During this process, the contact section 311 of the stability guide wire 31 provides the necessary supporting force and buffering to ensure the stability of each component during the atrial septum puncture process. Finally, the physician manually advances the puncture control handle 14 to perform a second atrial septum puncture with the dilatation sheath tube 13 along the directions of the puncture guide wire 11 and the microcatheter 12.

[0081] The embodiments of the present invention have been described above in conjunction with the accompanying drawings. However, the present invention is not limited to the above specific embodiments. The above specific embodiments are merely illustrative and not restrictive. Under the inspiration of the present invention, those of ordinary skill in the art can also make many forms without departing from the spirit and scope protected by the claims of the present invention, and all of them fall within the protection scope of the present invention.

Claims

1. An atrial septum puncture device, characterized in that, It includes a puncture execution component and a puncture guide component; The puncture execution assembly includes a puncture guidewire, a microcatheter, and an expansion sheath arranged in sequence from the inside out, and a puncture control handle connected to the proximal ends of the three. The puncture guidewire is used to perform a primary electrical puncture of the atrial septum, the microcatheter is used to position the distal end of the puncture guidewire, and the distal end of the expansion sheath is provided with a puncture portion for performing a secondary electrical puncture of the atrial septum. The puncture guide assembly includes a bending sheath and a bending control handle, the bending control handle is used to control the bending angle of the bending sheath, the bending sheath is provided with an axially through-going first lumen, the first lumen is used to pass the expansion sheath.

2. The atrial septum puncture device according to claim 1, wherein The distal end of the puncture guidewire is provided with a puncture head, which is configured to be blunt-headed; the proximal end of the puncture guidewire is fixed to the puncture control handle and can be electrically connected to the electric energy generating device.

3. The atrial septum puncture device according to claim 1, characterized in that, A positioning ring is provided at the distal end of the microcatheter. The positioning ring is configured as an annular developing structure and is used to determine the puncture position before puncture.

4. The atrial septum puncture device according to claim 1, characterized in that, The puncture part includes an electrode tip arranged at the distal end of the expansion sheath, the electrode tip is connected to a wire pre-buried inside the expansion sheath, the wire extends into the puncture control handle and can be electrically connected to the power generating device.

5. The atrial septum puncture device according to claim 4, characterized in that, The dilatation sheath further includes a pressure sensor, which is disposed on the proximal side of the electrode tip and is used to detect pressure changes during the puncture process and to control the energization state of the electrode tip.

6. The atrial septum puncture device according to claim 1, wherein The puncture control handle includes a microcatheter control knob and a puncture guidewire control button. The microcatheter control knob is used to control the extension and retraction of the microcatheter, and the puncture guidewire control button is used to control the extension and retraction of the puncture guidewire, so that the puncture guidewire and the microcatheter can be operated independently.

7. The atrial septum puncture device according to claim 1, wherein The bending adjustment sheath is also provided with a second lumen, which is used to pass a stabilizing guide wire. The distal end of the stabilizing guide wire is used to contact the inner wall of the superior vena cava in the heart and buffer the displacement of the device caused by heart beating.

8. The atrial septum puncture device according to claim 7, characterized in that, The stabilizing guide wire includes a contact segment and a support segment connected sequentially from the distal end to the proximal end, wherein the contact segment has a smaller elastic modulus or stiffness than the support segment; the contact segment is spiral-shaped, for providing buffering and increasing the contact area with the endocardium; the support segment is straight rod-shaped, for providing supporting force.

9. The atrial septum puncture device according to claim 8, characterized in that, The contact section is a conical spiral structure with multiple turns, and the spiral diameter of the conical spiral structure gradually increases from the proximal end to the distal end.

10. The atrial septum puncture device according to claim 1, characterized in that, A traction wire is passed through the inner wall of the bending adjustment sheath, the distal end of the traction wire is fixedly connected to the distal end of the bending adjustment sheath, and the proximal end of the traction wire is connected to the bending adjustment control handle.

11. The atrial septum puncture device according to claim 10, wherein, The bending control handle includes a handle shell, a fixing tube, a bending knob, a bending driving member and a bending moving member; The fixed tube is fixed inside the handle housing. The bending adjustment knob is connected to the bending adjustment driving member and sleeved outside the fixed tube. The bending adjustment driving member is threadedly connected to the bending adjustment moving member. The bending adjustment moving member is sleeved on the outer periphery of the fixed tube and connected to the proximal end of the traction wire. By rotating the bending adjustment knob, the bending adjustment moving member can be driven to axially move, so as to adjust the tension of the traction wire and realize the control of the bending angle of the distal end of the bending sheath tube.

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