Atrial septostomy device

Abstract

This invention relates to an atrial septal puncture device, comprising: a handle housing having a receiving cavity; a sheath assembly having a proximal end extending into the receiving cavity of the handle housing; a puncture needle inserted into the sheath assembly, the puncture needle having a first state of being fixed relative to the sheath assembly and a second state of being axially movable relative to the sheath assembly under external force; a linkage mechanism movably disposed in the receiving cavity, the linkage mechanism including a first linkage component connected to the puncture needle; a first drive component disposed on the handle housing and passing through the handle housing and connected to the first linkage component; an external force is applied to the first drive component, the first drive component drives the first linkage component to cause the puncture needle connected to the first linkage component to move axially relative to the sheath assembly, thereby allowing the distal end of the puncture needle to extend beyond the distal end of the sheath assembly. This invention aims to provide an atrial septal puncture device that can save surgical time and reduce surgical risks.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an atrial septal puncture device. Background Technology

[0002] In some medical applications, it is often necessary to deliver medical devices into the left atrium, such as in procedures like left atrial appendage occlusion, atrial fibrillation ablation, and mitral valve replacement. Accessing the left atrium via blood vessels connected to it is extremely difficult due to the tortuous nature of these vessels. Therefore, the most common method for accessing the left atrium is to use intravenous puncture to push the medical device into the right atrium and then through interatrial septal puncture to enter the left atrium.

[0003] Traditional transseptal puncture requires the use of two instruments: a puncture sheath and a puncture needle. During the procedure, the puncture sheath is first inserted into the correct position, and then the puncture needle is inserted into the body through the puncture sheath to perform the puncture operation. The distal end of the puncture needle has a beveled, pointed structure to facilitate easy puncture of the transseptal region.

[0004] Existing equipment, with its separate puncture sheath and needle, is prone to scraping the inner wall of the sheath and generating debris during the needle's movement from the proximal to the distal end. If this debris enters the blood vessel, it can lead to thrombosis and harm the patient. Furthermore, when the physician manually advances the needle to puncture the atrial septum, the advance distance is uncontrollable. The needle may pass through the septum into the left atrium and, due to inertia, continue to move forward, potentially piercing the left atrial wall and causing cardiac tamponade, or even piercing the aorta, leading to serious complications and harming the patient. After the atrial septum puncture is completed, the lack of fixation between the two components can cause relative movement, affecting further procedures. Overall, this separate, step-by-step approach results in a prolonged procedure time and high risk. Summary of the Invention

[0005] In view of the above problems, the present invention aims to provide an atrial septum puncture device that can save surgical time and reduce surgical risks.

[0006] This objective is achieved through the following technical solutions:

[0007] This invention provides a transseptal puncture device, the transseptal puncture device comprising:

[0008] A handle housing having a receiving cavity;

[0009] A sheath assembly, the proximal end of which extends into the receiving cavity of the handle housing;

[0010] A puncture needle is inserted into the sheath assembly, and the puncture needle has a first state that is fixed relative to the sheath assembly and a second state that moves axially relative to the sheath assembly under the drive of an external force.

[0011] A linkage mechanism is movably disposed in the receiving cavity, and the linkage mechanism includes a first linkage component connected to the puncture needle;

[0012] A first drive assembly is disposed on the handle housing and passes through the handle housing and is connected to the first linkage assembly; an external force is applied to the first drive assembly, and the first drive assembly drives the first linkage assembly to drive the puncture needle connected to the first linkage assembly to move axially relative to the sheath assembly, so that the distal end of the puncture needle can extend out of the distal end of the sheath assembly.

[0013] In some embodiments of the present invention, the linkage mechanism further includes:

[0014] The second linkage component is connected to the first driving component;

[0015] The proximal end of the sheath assembly is connected to the second linkage assembly, and the proximal end of the puncture needle extends from the proximal end of the sheath assembly and is connected to the first linkage assembly. The first drive assembly drives the first linkage assembly and the second linkage assembly to move the puncture needle and the sheath assembly in opposite directions simultaneously.

[0016] In some embodiments of the present invention, the interventricular septal puncture device further includes:

[0017] A clutch assembly is disposed on the handle housing and passes through the handle housing to cooperate with the second linkage assembly;

[0018] The clutch assembly and the second linkage assembly have a first engagement state and a second engagement state.

[0019] In the first engaged state, the second linkage component is separated from the sheath assembly;

[0020] In the second engagement state, the second linkage component is connected to the sheath assembly.

[0021] In some embodiments of the present invention, the first linkage component includes:

[0022] The first transmission component is connected to the first drive component in a transmission manner;

[0023] The first sliding member slides in cooperation with the inner wall of the accommodating cavity. The first sliding member connects the first transmission assembly and the proximal end of the puncture needle, so that the first sliding member can be driven to slide by the first transmission assembly, thereby driving the puncture needle connected to the first sliding member to move axially.

[0024] The second linkage component includes:

[0025] The second transmission component is connected to the first drive component in a transmission manner;

[0026] The second sliding member slides against the inner wall of the accommodating cavity. The second sliding member connects the second transmission assembly and the proximal end of the sheath assembly, so that the second sliding member can be driven to slide through the second transmission assembly, thereby driving the sheath assembly connected to the second sliding member to move axially.

[0027] The first driving component drives the first transmission component and the second transmission component in a coordinated manner to drive the first slider and the second slider to move in opposite directions simultaneously.

[0028] The clutch assembly has a mating member, and the second sliding member has a mating part that mates with the mating member. The mating member and the mating part mate to achieve the first mating state and the second mating state.

[0029] The clutch assembly has a mating member, and the second sliding member has a mating part that mates with the mating member. The mating member and the mating part mate to achieve the first mating state and the second mating state.

[0030] In some embodiments of the present invention, the first driving component includes a drive gear, and the first sliding member is provided with a first threaded hole;

[0031] The first transmission assembly includes a first driven gear and a first screw connected together. The first screw passes through and engages with the first threaded hole, and both ends of the first screw are rotatably connected to the handle housing.

[0032] The second transmission assembly includes a second driven gear, a second screw connected to the second driven wheel, and a transmission nut sleeved on the second screw. The two ends of the second screw are rotatably connected to the handle housing.

[0033] In the first mating state, the transmission nut is separated from the mating part by the mating component;

[0034] In the second mating state, the transmission nut is connected to the mating part through the mating component.

[0035] In some embodiments of the present invention, the mating part is a deformable claw structure, and the claw structure is provided with mating holes;

[0036] The mating part has a pin portion that engages with the mating hole;

[0037] In the first mating state, the pin is inserted into the mating hole and opens the claw structure, so that the claw structure is separated from the transmission nut;

[0038] In the second mating state, the pin portion separates from the mating hole, and the claw structure clamps the transmission nut.

[0039] In some embodiments of the present invention, the ratio of the number of teeth of the first driven gear and the second driven gear is greater than or equal to 1; and / or, the ratio of the pitch of the second screw to the pitch of the first screw is greater than or equal to 1.

[0040] In some embodiments of the present invention, the clutch assembly further includes a positioning button, a connecting rod, and an elastic element. The positioning button is located outside the receiving cavity. One end of the connecting rod is connected to the positioning button, and the other end of the connecting rod extends into the receiving cavity and is connected to the mating member. The elastic element is sleeved on the connecting rod, and one end of the elastic element abuts against the mating member, while the other end of the elastic element abuts against the inner wall of the receiving cavity.

[0041] In the first mating state, the elastic member applies an elastic force toward the mating part to the mating member.

[0042] In some embodiments of the present invention, the outer wall of the handle housing is provided with a first limiting groove and a second limiting groove recessed toward the mating part, the position of the positioning button can be switched between the first limiting groove and the second limiting groove, and the depth of the first limiting groove is greater than the depth of the second limiting groove.

[0043] In the first engagement state, the positioning button is located in the first limiting groove, and in the second engagement state, the positioning button is located in the second limiting groove.

[0044] In some embodiments of the present invention, the sheath assembly includes:

[0045] The inner liner is fitted over the outside of the puncture needle;

[0046] An insulating layer assembly is fitted over the outer side of the inner liner;

[0047] Electrode assembly, disposed on the insulating layer group;

[0048] An electrode wire, the distal end of which is connected to the electrode assembly, and the proximal end of which is used for connecting to an external calibration system device.

[0049] In some embodiments of the present invention, the insulating layer group includes a first insulating layer, a second insulating layer, and a third insulating layer;

[0050] The electrode assembly includes a first electrode and a second electrode;

[0051] The first electrode is sleeved outside the inner liner, the second insulating layer is sleeved outside the first electrode, the second electrode is sleeved outside the second insulating layer, the third insulating layer is sleeved outside the second electrode, the first insulating layer is sleeved outside the inner liner, and the distal end of the first insulating layer is flush with the inner liner, and the proximal end of the first insulating layer abuts against the distal end of the first electrode.

[0052] In some embodiments of the present invention, the insulating layer assembly includes a support layer and an insulating layer, wherein the support layer is sleeved outside the inner liner and the insulating layer is sleeved outside the support layer;

[0053] The electrode assembly includes a first electrode and a second electrode, both of which are sleeved outside the insulating layer and are spaced apart.

[0054] The distal end of the electrode wire is encapsulated within the insulating layer, and the proximal end of the electrode wire extends from the proximal end of the insulating layer.

[0055] The atrial septal puncture device of the present invention integrates the sheath assembly and the puncture needle. The puncture needle is housed within the sheath assembly, with its distal end close to the distal end of the sheath assembly. The puncture needle does not travel from the proximal to the distal end of the sheath, thus eliminating the risk of scraping the inner wall of the puncture needle and generating debris that could lead to thrombosis. Furthermore, the puncture needle is driven by a first driving assembly and a first linkage assembly, ensuring precise and controllable insertion and extension distances. This prevents the puncture needle from continuing to move forward after passing through the atrial septum and entering the left atrium, potentially piercing the left atrial wall, aorta, or other tissue structures. Moreover, the puncture needle and sheath assembly can be relatively fixed, resulting in better stability of the puncture needle during the procedure. In a further proposed approach, during needle withdrawal, the puncture needle and sheath assembly can move in opposite directions simultaneously. The puncture needle moves proximally, while the sheath assembly advances distally, allowing the puncture needle to be quickly withdrawn into the sheath assembly. Simultaneously, the puncture needle provides strong support to the sheath assembly, effectively ensuring the strength of the distal end of the sheath assembly. This allows the sheath assembly to quickly and easily pass through the interatrial septum to create a dilated opening, facilitating the subsequent insertion of a larger diameter sheath. This superior approach allows for simultaneous rapid needle withdrawal and dilation in a single operation, reducing surgical time and lowering surgical risks. Attached Figure Description

[0056] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings:

[0057] Figure 1 A schematic diagram of the structure of a room partition puncture device according to an embodiment of the present invention is shown.

[0058] Figure 2 A partial cross-sectional view of the handle housing according to an embodiment of the present invention is shown schematically;

[0059] Figure 3 A schematic cross-sectional view of a room partition puncture device according to an embodiment of the present invention is shown.

[0060] Figure 4 schematically shown Figure 3 A magnified view of part A in the middle;

[0061] Figure 5 A schematic diagram illustrating the connection between the handle housing and the linkage mechanism according to an embodiment of the present invention is shown.

[0062] Figure 6 A schematic cross-sectional view of the handle housing and the second drive assembly according to an embodiment of the present invention is shown.

[0063] Figure 7 A partial cross-sectional view of the intercompartment puncture device in a first engagement state according to an embodiment of the present invention is shown schematically.

[0064] Figure 8 schematically shown Figure 7 A magnified view of part B in the middle section;

[0065] Figure 9 A partial cross-sectional view of the intercompartment puncture device in a second engagement state according to an embodiment of the present invention is shown schematically.

[0066] Figure 10 schematically shown Figure 9 A magnified view of part C in the middle;

[0067] Figure 11 A schematic diagram of the structure of a sheath assembly according to one embodiment of the present invention is shown.

[0068] Figure 12 A schematic diagram of the structure of a sheath assembly according to another embodiment of the present invention is shown;

[0069] Figure 13 A schematic diagram of the linkage mechanism according to one embodiment of the present invention is shown.

[0070] The attached figures are labeled as follows:

[0071] 100-Handle housing, 110-Accommodation cavity, 111-First slide groove, 112-Second slide groove, 113-First support part, 114-Second support part, 115-Third support part, 116-Fourth support part, 117-Bearing mounting position, 101-First limiting groove, 102-Second limiting groove, 103-Guide through groove, 104-Annular protrusion, 105-Second annular groove, 106-Second scale, 107-Mounting groove, 108-First through hole, 109-Allowing groove, 1091-Second spring limiting groove, 120-Bearing cover, 130-Connecting plug;

[0072] 200 - First drive assembly, 210 - Drive gear, 220 - Adjustment knob;

[0073] 300 - Linkage mechanism; 310 - First linkage assembly; 311 - First transmission assembly; 3111 - First driven gear; 3112 - First screw; 312 - First sliding member; 3121 - First threaded hole; 3122 - First sliding part; 3123 - Third through hole; 320 - Second linkage assembly; 321 - Second transmission assembly; 3211 - Second driven gear; 3212 - Second screw; 3213 - Transmission nut; 322 - Second sliding member; 3221 - Mating part; 32211 - First sub-claw; 32212 - Second sub-claw; 32213 - Mating hole; 3222 - Second sliding part; 3223 - Second through hole; 32231 - Stepped structure; 3224 - Extension rod; 3225 - Luer connector.

[0074] 330-crank, 331-first hinge, 332-second hinge, 340-first connecting rod, 350-second connecting rod;

[0075] 400-Sheath assembly, 410-Inner liner, 420-Insulating layer assembly, 421-First insulating layer, 422-Second insulating layer, 4221-Second boss structure, 423-Third insulating layer, 424-Support layer, 425-Insulating layer, 430-Electrode assembly, 431-First electrode, 4311-First boss structure, 432-Second electrode, 4321-Third boss structure, 440-Electrode wire;

[0076] 500-Clutch assembly, 510-Matching part, 511-Pin part, 512-First spring limiting groove, 520-Positioning button, 521-Second threaded hole, 530-Connecting rod, 540-Elastic element;

[0077] 600-Second drive assembly, 610-Adjusting nut, 611-First annular groove, 612-First scale, 620-Adjusting slider, 621-Guide boss, 622-First through hole;

[0078] 700-puncture needle;

[0079] 800-Torture Rope. Detailed Implementation

[0080] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0081] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0082] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0083] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0084] It should be noted that the terms "distal" and "proximal" are used as directional terms, which are commonly used in the field of interventional medical devices. "Distal" refers to the end furthest from the operator during the procedure, while "proximal" refers to the end closest to the operator. Axial direction refers to the direction parallel to the line connecting the center of the distal and proximal ends of the medical device; radial direction refers to the direction perpendicular to the aforementioned axial direction.

[0085] Please combine Figure 1 , Figure 3 and Figure 7 As shown, according to an embodiment of the present invention, a transseptal puncture device is provided.

[0086] The atrial septal puncture device includes: a handle housing 100, a first drive assembly 200, a linkage mechanism 300, a sheath assembly 400, and a puncture needle 700. For example, the handle housing 100 is cylindrical in shape, and its interior is hollow, forming a receiving cavity 110. The linkage mechanism 300 is disposed within the receiving cavity 110, and the proximal portions of the sheath assembly 400 and the puncture needle 700 both pass through the receiving cavity 110. The sheath assembly 400 is sleeved outside the puncture needle 700. The inner diameter of the sheath assembly 400 is larger than the outer diameter of the puncture needle 700. The puncture needle 700 has a first state in which it is relatively fixed relative to the sheath assembly 400, and a second state in which it moves axially relative to the sheath assembly 400 under external force. The distal end of the puncture needle 700 is located inside the sheath assembly 400 and close to the distal end of the sheath assembly 400. During the interventional procedure, the sheath assembly 400 and the puncture needle 700 are inserted together into the patient's blood vessel or ventricle. During insertion, there is no relative movement between the sheath assembly 400 and the puncture needle 700. The puncture needle 700 is housed within the sheath assembly 400, with its distal end close to the distal end of the sheath assembly 400. The puncture needle 700 does not move from the proximal end to the distal end of the sheath assembly 400. Therefore, there is no risk of scraping the inner wall of the puncture needle and generating debris that could lead to thrombosis, thus improving the safety of the procedure. At the same time, this method allows the sheath assembly 400 and the puncture needle 700 to enter simultaneously, eliminating the need for step-by-step operations and greatly saving surgical time.

[0087] The linkage mechanism 300 includes a first linkage component 310 connected to the puncture needle 700. A first drive component 200 is disposed on the handle housing 100 and passes through the handle housing 100 and is connected to the first linkage component 310. An external force is applied to the first drive component 200, for example, by manually driving the first drive component 200 or by using a motor or other device. The first drive component 200 drives the first linkage component 310 to move the puncture needle 700 axially relative to the sheath assembly 400, thereby allowing the distal end of the puncture needle 700 to extend beyond the distal end of the sheath assembly 400. In this embodiment, by driving the puncture needle 700 through the first drive component 200 and the first linkage component 310, the insertion and extension distances of the puncture needle 700 are precise and controllable, preventing the puncture needle from continuing to move forward after passing through the interatrial septum and entering the left atrium, thus preventing it from piercing the left atrial wall, aorta, or other tissue structures. Furthermore, the puncture needle and sheath assembly can be relatively fixed, resulting in better stability of the puncture needle during the operation.

[0088] In some embodiments of the present invention, such as Figure 7As shown, the linkage mechanism 300 further includes a second linkage component 320. Specifically, the proximal end of the puncture needle 700 extends from the proximal end of the sheath assembly 400, such that the proximal end of the puncture needle 700 is positioned relative to the proximal side of the sheath assembly 400. Both the first linkage component 310 and the second linkage component 320 are movable within the receiving cavity 110. The first linkage component 310 is positioned relative to the proximal end of the second linkage component 320 and is connected to the proximal end of the puncture needle 700, while the second linkage component 320 is connected to the proximal end of the sheath assembly 400. The first drive component 200 is movably mounted on the handle housing 100. Both the first linkage component 310 and the second linkage component 320 are driveably connected to the first drive component 200. Under the drive of the first drive component 200, the first linkage component 310 and the second linkage component 320 drive the puncture needle 700 and the sheath assembly 400 to move in opposite directions, respectively. For example, the second drive assembly 600 drives the proximal end of the sheath assembly 400 to move away from the proximal end of the sheath assembly 400, that is, the proximal end of the sheath assembly 400 and the proximal end of the puncture needle 700 move in opposite directions. This causes the distal end of the puncture needle 700 to retract into the sheath assembly 400 while the distal end of the sheath assembly 400 moves forward. This shortens the travel distance of the puncture needle 700 outside the sheath assembly 400 during the retraction process, allowing the puncture needle 700 to retract quickly into the sheath assembly 400. The fast retraction speed reduces the risk of accidental injury from the puncture needle 700. Furthermore, during needle withdrawal, the puncture needle and sheath assembly can move in opposite directions simultaneously. The puncture needle moves proximally, while the sheath assembly advances distally, allowing the puncture needle to be quickly retracted into the sheath assembly. At the same time, the puncture needle provides strong support, effectively ensuring the strength of the distal end of the sheath assembly, enabling the sheath assembly to quickly and easily pass through the interatrial septum to form a dilated orifice, thus facilitating the subsequent insertion of a larger diameter sheath.

[0089] It should be noted that, please refer to... Figure 7 and Figure 13As shown, this embodiment does not limit the movement direction of the proximal end of the puncture needle 700 and the proximal end of the sheath assembly 400. Since the sheath assembly 400 and the puncture needle 700 may be bent according to actual needs, as long as the proximal end of the puncture needle 700 and the proximal end of the sheath assembly 400 move in opposite directions, the technical effect of the distal end of the puncture needle 700 retracting while the distal end of the sheath assembly 400 advances forward can be achieved. Understandably, based on this, the linkage mechanism 300 can be selected from different structural forms, such as a screw and nut mechanism, a combination of a screw and nut mechanism and a diamond four-bar linkage, a crank-slider mechanism, or a bidirectional hydraulic cylinder mechanism with two opposing piston rods. As long as the linkage mechanism 300 includes two modules or structures that move in opposite directions and are respectively connected to the proximal end of the puncture needle 700 and the proximal end of the sheath assembly 400, and can achieve the opposite movement of the proximal end of the sheath assembly 400 and the proximal end of the puncture needle 700, it is within the protection scope of this invention.

[0090] It should be noted that "movement in opposite directions" refers to movement in a direction away from each other. In this embodiment, the proximal ends of the sheath assembly and the puncture needle move in opposite directions, meaning they move away from each other. "Movement in opposite directions" refers to movement in a direction closer to each other, meaning they move towards each other. "Reverse movement" includes both "movement in opposite directions" and "movement in opposite directions."

[0091] In some embodiments of the present invention, such as Figures 7-10As shown, the interatrial septal puncture device further includes a clutch assembly 500, which is disposed on the handle housing 100 and passes through the handle housing 100 to cooperate with the second linkage assembly 320. The clutch assembly 500 and the second linkage assembly 320 have a first engagement state and a second engagement state. In the first engagement state, the second linkage assembly 320 is separated from the sheath assembly 400, such that in the first engagement state, when the first drive assembly 200 drives the first transmission assembly 311 and the second transmission assembly 321 to engage, the sheath assembly 400 remains stationary relative to the interatrial septum, while the first linkage assembly pushes the puncture needle 700 to move distally, thereby causing the distal end of the puncture needle 700 to extend from the distal end of the sheath assembly 400 and puncture the interatrial septum to complete the puncture action. In the second engagement state, the second linkage component 320 is connected to the sheath assembly 400. When the first drive component 200 drives the first transmission component 311 and the second transmission component 321 in linkage, the distal end of the sheath assembly 400 extends forward (towards the distal end) while the distal end of the puncture needle 700 retracts backward (towards the proximal end), thereby shortening the travel distance of the puncture needle 700 outside the sheath assembly 400 during the retraction process, resulting in a fast needle retraction speed. The clutch component 500 ensures that during the puncture process, in the first engagement state, the sheath assembly 400 remains in contact with the interatrial septum, and the puncture needle 700 advances relative to the sheath assembly 400. The puncture needle 700 is unaffected by the sheath assembly 400, and the advancement process is controllable, preventing the puncture needle from piercing the left atrial wall due to inertia. During the needle withdrawal process after puncture, in the second state, the sheath assembly 400 advances while the puncture needle retracts, allowing the puncture needle to be quickly retracted into the sheath assembly 400, saving surgical time and avoiding the risk of accidental puncture injury during withdrawal. Simultaneously, the puncture needle provides strong support, effectively ensuring the strength of the distal end of the sheath assembly, allowing the sheath assembly to quickly and easily pass through the interatrial septum to create a dilated opening, thus facilitating the subsequent insertion of a larger diameter sheath.

[0092] In some embodiments of the present invention, please refer to Figure 5 , Figure 7 and Figure 9As shown, the first linkage component 310 includes a first transmission component 311 and a first sliding member 312, and the second linkage component 320 includes a second transmission component 321 and a second sliding member 322. Specifically, both the first transmission component 311 and the second transmission component 321 are connected to the first drive component 200. The first sliding member 312 is connected to the first transmission component 311, and the second sliding member 322 is connected to the second transmission component 321. The first transmission component 311 transmits the power output from the first drive component 200 to the first sliding member 312 to drive the first sliding member 312 to slide within the receiving cavity 110. The second transmission component 321 transmits the power output from the first drive component 200 to the second sliding member 322 to drive the second sliding member 322 to slide within the receiving cavity 110. Since the first transmission component 311 and the second transmission component 321 are both connected to the first transmission member, when the first drive component 200 outputs power, it can ensure that the first sliding member 312 and the second sliding member 322 slide simultaneously. Furthermore, by symmetrically arranging the first linkage component 310 and the second linkage component 320 on both sides of the first drive component 200, the first sliding member 312 and the second sliding member 322 can move in opposite directions under the drive of the first drive component 200. The first sliding member 312 is connected to the proximal end of the puncture needle 700, and the second sliding member 322 is connected to the proximal end of the sheath assembly 400. Both the first sliding member 312 and the second sliding member 322 slide in cooperation with the inner wall of the receiving cavity 110, so that the first sliding member 312 and the second sliding member 322 can move axially under the constraint of the inner wall of the receiving cavity 110, so as to more accurately define the movement direction of the sheath assembly 400 and the puncture needle 700. The movement direction of the sheath assembly 400 and the puncture needle 700 is parallel to their own axis, so that the relative movement of the puncture needle 700 and the sheath assembly 400 is smoother.

[0093] It should be noted that reverse movement includes both moving towards each other and moving away from each other. When the first slider 312 and the second slider 322 move towards each other, the distal end of the sheath assembly 400 retracts proximally relative to the puncture needle 700, and the distal end of the puncture needle 700 extends distally relative to the sheath assembly 400, so that the distal end of the puncture needle 700 extends from the distal end of the sheath assembly 400 to perform the interventricular septal puncture. When the first slider 312 and the second slider 322 move away from each other, the distal end of the sheath assembly 400 extends distally relative to the puncture needle 700, and the distal end of the puncture needle 700 retracts proximally relative to the sheath assembly 400, so that the distal end of the puncture needle 700 retracts into the sheath assembly 400, so as to simultaneously perform the needle retraction and diaphragm dilation actions.

[0094] In some embodiments of the present invention, please refer to Figure 1 , Figure 8 and Figure 10As shown, exemplarily, the clutch assembly 500 is disposed on the handle housing 100 corresponding to the second sliding member 322. The clutch assembly 500 has a mating member 510, and the second sliding member 322 has a mating portion 3221 that mates with the mating member 510. The mating member 510 and the mating portion 3221 have a first mating state and a second mating state. In the first mating state, the second sliding member 322 is stationary relative to the handle housing 100. In the second mating state, the second sliding member 322 can slide relative to the handle housing 100 under the drive of the second transmission assembly 321.

[0095] Understandably, the clutch assembly 500 controls the transition between a relatively stationary state and a relatively sliding state between the second slider 322 and the handle housing 100. Optionally, when the puncture needle 700 extends distally to perform a puncture action, the mating member 510 and the mating part 3221 are configured in a first mating state. Since the second slider 322 is stationary relative to the handle housing 100, the sheath assembly 400 remains stationary. The first slider 312 pushes the puncture needle distally, thereby causing the distal end of the puncture needle to extend from the distal end of the sheath assembly 400 and puncture the interatrial septum to complete the puncture action. When the puncture needle moves proximally and retracts to perform the needle retraction action, the first drive assembly 200 drives the first transmission assembly 311 and the second transmission assembly 321 in conjunction, causing the first sliding member 312 and the second sliding member 322 to move in opposite directions. At this time, the mating member 510 and the mating part 3221 are configured in a second mating state, allowing the second sliding member 322 to slide relative to the handle housing 100. With the proximal ends of the sheath assembly 400 and the puncture needle 700 moving in opposite directions, the distal end of the sheath assembly 400 extends while the distal end of the puncture needle 700 retracts, thereby shortening the travel distance of the puncture needle 700 outside the sheath assembly 400 during the retraction process, achieving rapid needle retraction. Simultaneously, the puncture needle provides strong support, effectively ensuring the strength of the distal end of the sheath assembly, allowing the sheath assembly to quickly and easily pass through the interatrial septum to form a dilated orifice, thus facilitating the subsequent insertion of a larger diameter sheath. This method allows for both needle removal and hole enlargement in a single operation, with faster needle removal and quicker, easier hole enlargement.

[0096] The clutch assembly 500 and the second sliding member 322 can have various engagement methods to change the relative state between the second sliding member 322 and the handle housing 100. For example, the engagement part can be a hole-like structure provided in the second sliding member, and the clutch assembly can be a pin-like connector. In the first engagement state, the pin-like connector passes through both the handle housing and the second sliding member, connecting the second sliding member and the handle housing as a whole, thus keeping the second sliding member and the handle housing stationary. It should be noted that, in the state where the second sliding member is connected to the handle housing, to ensure that the linkage mechanism has a degree of freedom of movement, all parts of the linkage mechanism except the second sliding member can move relative to the handle housing. In the second engagement state, the pin-like connector is pulled out from the hole-like structure of the second sliding member, allowing the second sliding member to slide relative to the handle housing. Understandably, the engagement relationship between the clutch assembly and the second sliding member can also be set in other forms.

[0097] The technical solution of the present invention will be further described in detail below with reference to specific embodiments.

[0098] Implementation Method 1

[0099] In this embodiment, such as Figure 3 and Figure 7 As shown, the linkage mechanism 300 consists of two lead screw and nut mechanisms arranged in opposite directions. By converting the rotation of the lead screw into the linear motion of the nut, the first sliding member 312 serves as one of the nuts, and the second sliding member 322 is connected to the other nut structure, so as to realize the opposite movement of the first sliding member 312 and the second sliding member 322 by driving the rotation of the two lead screws.

[0100] In detail, the sheath assembly 400, the puncture needle 700, and the linkage mechanism 300 are all installed in the receiving cavity 110 of the handle housing 100, and the axis of the handle housing 100 coincides with the axis of the sheath assembly 400 and the puncture needle 700. Please refer to... Figure 2 and Figure 5 As shown, the first drive assembly 200 includes an adjustment knob 220 and a drive gear 210. The outer wall of the handle housing 100 is provided with a mounting groove 107 for accommodating the adjustment knob. The bottom wall of the mounting groove 107 is provided with a first through hole 108 penetrating the handle housing 100. The adjustment knob 220 includes an adjustment body rotatably disposed in the mounting groove 107 and a rod-shaped connecting part connected to the adjustment body. The rod-shaped connecting part extends into the receiving cavity 110 through the first through hole 108 and is connected to the drive gear 210 disposed in the receiving cavity 110. The mounting groove 107 is mainly used to accommodate the adjustment body, so that the adjustment body is lowered relative to the handle housing 100 as a whole, reducing the probability of accidentally touching the adjustment knob 220.

[0101] Please refer to this again. Figure 2 , Figure 5 and Figure 6 The first transmission assembly 311 includes a first driven gear 3111 and a first screw 3112 connected together. The second transmission assembly 321 includes a second driven gear 3211, a second screw 3212, and a transmission nut 3213. The second driven gear 3211 is connected to the second screw 3212, and the transmission nut 3213 is sleeved on the second screw 3212 and threadedly engaged with it. Along the axial direction of the handle housing 100, from the proximal end to the distal end, the handle housing 100 is provided with a first support portion 113, a second support portion 114, a third support portion 115, and a fourth support portion 116 that protrude from the inner wall of the accommodating cavity 110 and are arranged sequentially at intervals. The driving gear 210, the first driven gear 3111, and the second driven gear 3211 are located between the second support portion 114 and the third support portion 115. The two ends of the first screw 3112 are rotatably mounted on the first support portion 113 and the second support portion 114, respectively. The two ends of the second screw 3212 are rotatably mounted on the third support portion 115 and the fourth support portion 116, respectively. The first screw 3112 is located on the proximal side relative to the second screw 3212. The axis of the first screw 3112 coincides with the axis of the second screw 3212 and is parallel to the axis of the handle housing 100. The first sliding member 312 is provided with a first threaded hole 3121 that mates with the first screw 3112. The first screw 3112 passes through the first threaded hole 3121 and mates with the first threaded hole 3121. The first driven gear 3111 and the second driven gear 3211 both mesh with the driving gear 210. The adjustment knob 220 is manually rotated to drive the first screw 3112 to rotate around its own axis in the accommodating cavity 110 through the driving gear 210 and the first driven gear 3111. This causes the first sliding member 312 to move along the axial direction of the first screw 3112. At the same time, the driving gear 210 also drives the second driven gear 3211 to rotate, causing the second screw 3212 to rotate around its own axis in the accommodating cavity 110. This, in turn, causes the transmission nut 3213 to move along the axial direction of the second screw 3212.

[0102] It should be noted that, as Figure 5 As shown, in this embodiment, the driving gear 210, the first driven gear 3111, and the second driven gear 3211 are all bevel gears. Therefore, when the driving gear 210 rotates in a certain direction, the rotation directions of the first driven gear 3111 and the second driven gear 3211 are opposite, which in turn causes the rotation directions of the first screw 3112 and the second screw 3212 to be opposite. Moreover, the threads on the first screw 3112 and the second screw 3212 have the same direction of rotation. Therefore, the opposite rotation of the first screw 3112 and the second screw 3212 drives the transmission nut 3213 and the first sliding member 312 to move in opposite directions.

[0103] Understandably, in other embodiments, the driving gear, the first driven gear, and the second driven gear may all be spur gears (not shown in the figure). When the driving gear rotates in a certain direction, the first driven gear and the second driven gear rotate in the same direction, thereby making the first screw and the second screw rotate in the same direction, and the threads of the first screw and the second screw turn in opposite directions (not shown in the figure), so that the transmission nut and the first sliding member move in opposite directions.

[0104] In this regard, please combine Figure 7 and Figure 8 As shown, in the first engagement state, the transmission nut 3213 separates from the engagement part 3221 via the engagement member 510, causing the transmission nut 3213 to disengage from the second sliding member 322. When the transmission nut 3213 moves axially under the drive of the second screw 3212, the second sliding member 322 is not affected by the driving force of the first drive assembly 200, and the second sliding member 322 remains relatively stationary with respect to the handle housing 100. Therefore, in the first engagement state, the first sliding member 312 and the transmission nut 3213 can be moved towards each other by rotating the adjusting nut 610. With the second sliding member 322 remaining stationary relative to the handle housing 100, the first sliding member 312 can be moved toward the distal end, keeping the sheath assembly 400 stationary and moving the puncture needle 700 toward the distal end so that the distal end of the puncture needle 700 extends out of the sheath to perform the interventricular septal puncture.

[0105] Please combine Figure 9 and Figure 10 As shown, in the second engagement state, the transmission nut 3213 is connected to the engagement part 3221 via the engagement member 510, making the transmission nut 3213 and the second sliding member 322 integral. When the transmission nut 3213 moves axially under the drive of the second screw 3212, it drives the second sliding member 322 to move relative to the handle housing 100. Therefore, in the second engagement state, the first sliding member 312 and the second sliding member 322 can be moved in opposite directions by rotating the adjusting nut 610 to simultaneously perform the needle retraction and hole enlargement actions.

[0106] It should be noted that in this embodiment, the connection state between the transmission nut 3213 and the mating part 3221 is changed by the mating part 510 to change the relative state between the second sliding member 322 and the handle housing 100.

[0107] Understandably, in other embodiments, the mating component can be a connector (not shown in the figure) used to connect the transmission nut and the second sliding component together. In the first mating state, the mating component disengages from the mating portion of the second sliding component or the transmission nut, so that the transmission nut is disengaged from the second sliding component. In the second mating state, the mating component is connected to both the second sliding component and the transmission nut, so that the two are connected together. For example, the second sliding component has a slot structure (not shown in the figure), and the mating component includes a snap-fit ​​structure that mates with the slot structure and a groove structure that mates with the transmission nut. In the first mating state, the transmission nut is snapped into the groove structure, and the snap-fit ​​structure is inserted into the slot structure, thereby connecting the transmission nut and the second sliding component together. Understandably, the mating component can also be mated to the transmission nut and the mating portion in other ways, as long as the mating component can be detachably connected to the transmission nut and the mating portion, all of which are within the protection scope of this invention.

[0108] In this embodiment, please refer to Figure 2 and Figure 5 As shown, to reduce the rotational resistance of the first screw 3112 and the second screw 3212, rotary bearings are provided in the first support portion 113, the second support portion 114, the third support portion 115, and the fourth support portion 116. Both ends of the first screw 3112 are cylindrical, allowing them to be inserted into the inner rings of the rotary bearings in the first support portion 113 and the second support portion 114, respectively. Similarly, both ends of the second screw 3212 are cylindrical, allowing them to be inserted into the inner rings of the rotary bearings in the third support portion 115 and the fourth support portion 116, respectively.

[0109] Specifically, the first support part 113, the second support part 114, the third support part 115 and the fourth support part 116 are all provided with bearing mounting positions 117. The axes of the four bearing mounting positions 117 overlap, and the four bearing mounting positions 117 are distributed on both sides of the adjustment knob 220. The bearings are set in the bearing mounting positions 117 and are pressed and fixed by the bearing cover 120.

[0110] In one exemplary implementation, such as Figure 8 and Figure 10As shown, the mating part 3221 is a deformable claw structure, with the claws generally arranged in a U-shape. It includes a first sub-claw 32211 and a second sub-claw 32212 arranged opposite each other. A transmission nut 3213 is located between the first sub-claw 32211 and the second sub-claw 32212. Each of the first sub-claw 32211 and the second sub-claw 32212 has a mating hole 32213. The mating component 510 has a pin portion 511 that engages with the mating hole 32213. Two pin portions 511 are symmetrically arranged, each pin portion 511 corresponding to one mating hole 32213. In the first mating state, the pin portion 511 inserts into the mating hole 32213 and spreads the first sub-claw 32211 and the second sub-claw 32212, causing the claw structure to separate from the transmission nut 3213. In the second engagement state, the pin portion 511 separates from the engagement hole 32213, and the first sub-claw 32211 and the second sub-claw 32212 elastically recover and clamp the transmission nut 3213.

[0111] In this embodiment, the mating hole 32213 is set as an oblong hole. The cross-section of the oblong hole has two opposing arc edges and a straight edge connecting the two arc edges. The length direction of the straight edge is the movement direction of the first sub-claw 32211 and the second sub-claw 32212. The oblong hole cooperates with the clutch assembly 500 to realize the axial positioning and fixing of the second sliding member 322, and to ensure that the axial position of the second sliding member 322 remains unchanged during the process of the claw structure gradually closing and fixing the transmission nut 3213.

[0112] In this embodiment, such as Figure 8 and Figure 10 As shown, the clutch assembly 500 includes a positioning button 520, a connecting rod 530, a mating part 510, and an elastic element 540. The positioning button 520 is located outside the receiving cavity 110. One end of the connecting rod 530 is connected to the positioning button 520, and the other end of the connecting rod 530 extends into the receiving cavity 110 and is connected to the mating part 510. The elastic element 540 is sleeved on the connecting rod 530, with one end of the elastic element 540 abutting against the mating part 510 and the other end abutting against the inner wall of the receiving cavity 110. In the first engagement state, the elastic element 540 applies an elastic force toward the mating part 3221 to the mating part 510 to ensure that the mating part 510 can be stably pressed against the pawl structure, ensuring that the transmission nut 3213 is disengaged from the pawl structure.

[0113] In this embodiment, such as Figure 8As shown, the elastic element 540 is a spring, and the connecting rod 530 and the mating part 510 are integrally formed. The connecting rod 530 is hollow inside, and a second threaded hole 521 is provided on the end face of the positioning button 520 facing the mating part 510. A screw is used to pass through the hollow structure of the connecting rod 530 and engage with the second threaded hole 521 to fix the positioning button 520 and the mating part 510 together. A first spring limiting groove 512 is provided on the end face of the mating part 510 facing the positioning button 520, and a second spring limiting groove 1091 is provided on the inner wall of the accommodating cavity 110 of the handle housing 100. The two ends of the spring are respectively located in the first spring limiting groove 512 and the second spring limiting groove 1091, and the two ends of the spring abut against the bottom wall of the first spring limiting groove 512 and the bottom wall of the second spring limiting groove 1091, respectively. The distance between the bottom wall of the first spring limiting groove 512 and the bottom wall of the second spring limiting groove 1091 is less than the natural length of the spring, so that the spring is in a compressed state, thereby providing the mating part 510 with an elastic force toward the mating part 3221.

[0114] Furthermore, such as Figure 8 and Figure 10 As shown, the outer wall of the handle housing 100 is provided with a first limiting groove 101 and a second limiting groove 102 recessed towards the mating part 3221. Both the first limiting groove 101 and the second limiting groove 102 are elongated, and the first limiting groove 101 is perpendicular to and intersects the second limiting groove 102. The contours of both the first limiting groove 101 and the second limiting groove 102 match the positioning button 520, allowing the position of the positioning button 520 to switch between within the first limiting groove 101 and the second limiting groove 102. When the positioning button 520 is located in the first limiting groove 101, the mating part 510 and the mating part 3221 are in a first mating state. When the positioning button 520 is located in the second limiting groove 102, the mating part 510 and the mating part 3221 are in a second mating state.

[0115] The depth of the first limiting groove 101 is greater than the depth of the second limiting groove 102. A clearance groove 109 is also provided on the inner wall of the accommodating cavity 110 corresponding to the mating part 510. The depth of the clearance groove 109 is greater than the difference in depth between the first limiting groove 101 and the second limiting groove 102. The difference in depth between the first limiting groove 101 and the second limiting groove 102 is the travel distance of the clutch assembly 500.

[0116] Specifically, please combine Figure 8 and Figure 10As shown, the clutch assembly 500 operates as follows: When disengaged, the positioning button 520 is located within the first limiting groove 101. The mating part 510 is in the opening between the first sub-claw 32211 and the second sub-claw 32212. The pin portion 511 is inserted into the mating hole 32213, spreading the first sub-claw 32211 and the second sub-claw 32212 apart, preventing them from contacting the transmission nut 3213. Simultaneously, the pin portion 511 engages with the mating hole 32213, fixing the position of the second sliding block. When engaged, the positioning button 520 is pulled outward and rotated 90°. At this time, the positioning button 520 is located within the second limiting groove 102. The mating part 510 retracts from the first sub-claw 32211 and the second sub-claw 32212, and the pin portion 511 retracts from the mating hole 32213. The first sub-claw 32211 and the second sub-claw 32212 then close and are fixedly connected to the transmission nut 3213. Since the length of the pin portion 511 is greater than the thickness of the main body of the mating part 510 and the mating hole 32213 is an oblong hole, when the positioning button 520 is pulled outward, it can be ensured that the pin portion 511 and the mating hole 32213 remain in a mating state before the claw structure is fully closed, and the position of the second sliding member 322 remains fixed.

[0117] In some implementations, such as Figure 5 and Figure 6 As shown, the inner wall of the accommodating cavity 110 is provided with a first sliding groove 111 and a second sliding groove 112. The length directions of the first sliding groove 111 and the second sliding groove 112 are both parallel to the axial direction of the handle housing 100. The first sliding member 312 is provided with a first sliding portion 3122 that slides in cooperation with the first sliding groove 111, and the second sliding member 322 is provided with a second sliding portion 3222 that slides in cooperation with the second sliding groove 112. The dimensions of the first sliding groove 111 and the second sliding groove 112 are matched with the sheath assembly 400, and their number is determined by the number of the first sliding portions 3122 and the second sliding portions 3222. Their length direction is the axial direction of the handle housing 100. The movement direction of the first sliding member 312 is limited by the cooperation between the first sliding portion 3122 and the first sliding groove 111, so that the first sliding member 312 only has the degree of freedom of movement along the axis and restricts the radial degree of freedom of the first sliding member 312. Similarly, the cooperation between the second sliding part 3222 and the second sliding groove 112 is used to limit the movement direction of the second sliding member 322, so that the second sliding member 322 only has the degree of freedom to move along the axis, and restricts the degree of freedom of the second sliding member 322 along the radial direction.

[0118] In this embodiment, in order to further shorten the travel distance of the puncture needle 700 outside the sheath assembly 400 during the needle retraction process, the first driven gear 3111 and the second driven gear 3211 are set to have different numbers of teeth, so that the ratio of the number of teeth of the first driven gear 3111 and the second driven gear 3211 is greater than or equal to 1; or the first screw 3112 and the second screw 3212 are set to have different pitches, so that the ratio of the pitch of the second screw 3212 to the pitch of the first screw 3112 is greater than or equal to 1, so as to achieve different transmission ratios, making the travel distance of the puncture needle 700 during retraction less than the travel distance of the sheath assembly 400 during forward movement, thereby shortening the travel distance of the puncture needle 700 outside the sheath assembly 400 during the needle retraction process.

[0119] For example, if the tooth ratio of the first driven gear 3111 and the second driven gear 3211 in the first stage of transmission is a, and the first screw 3112 and the second screw 3212 are set to have different pitches, and the pitch ratio of the second screw 3212 to the first screw 3112 is b, then the first slider 312 and the second slider 322 can exhibit different sliding speeds when the adjustment knob 220 is rotated, with a speed ratio of a multiplied by b. For example, if the gear ratio of the first driven gear 3111 and the second driven gear 3211 is 2, and the pitch ratio of the second screw 3212 and the first screw 3112 is set to 3, then the sliding speed of the second sliding member 322 in the axial direction is 6 times that of the first sliding member 312. When the puncture needle 700 retracts by 1 mm, the sheath assembly 400 can advance by 6 mm. This is beneficial for achieving precise control of the puncture needle 700 in clinical practice and shortening the travel distance of the puncture needle 700 outside the sheath assembly 400 during the retraction process, thereby achieving rapid retraction of the puncture needle 700 and avoiding cardiac perforation.

[0120] Understandably, the values ​​of a and b can also be set to other values, which will not be limited here.

[0121] It is important to emphasize that by using gear meshing and thread adjustment, the extension position and distance of the puncture needle 700 can be made precise and controllable. This avoids the situation in existing equipment where, when the doctor manually pushes the puncture needle 700, due to inertia, after passing through the interatrial septum and entering the left atrium, the puncture needle 700 continues to move forward and pierces the left atrial wall, causing cardiac tamponade, or piercing the aorta and causing serious complications that endanger the patient.

[0122] In this embodiment, such as Figure 3 and Figure 6As shown, the atrial septal puncture device also includes a second drive assembly 600 and a traction rope 800. The second drive assembly 600 is movably disposed in the handle housing 100. The distal portion of the traction rope 800 is inserted into the interlayer of the sheath assembly 400, with the distal end of the traction rope 800 fixed to the distal end of the sheath assembly 400. The proximal end of the traction rope 800 is connected to the second drive assembly 600. The second drive assembly 600 can drive the proximal end of the traction rope 800 to move to tighten or loosen the traction rope 800. When the second drive assembly 600 tightens the traction rope 800, the distal end of the sheath assembly 400 bends; when the second drive assembly 600 loosens the traction rope 800, the distal end of the sheath assembly 400 straightens. Therefore, when the initial bending angle of the puncture needle 700 is not good after entering the right atrium, the distal end of the sheath assembly 400 can be bent at an appropriate angle by adjusting the second drive assembly 600, so as to adjust the puncture angle of the puncture needle 700. There is no need to remove the puncture needle 700 and reshape the angle of the puncture needle 700. On the one hand, the positional accuracy of the puncture needle 700 is improved, and on the other hand, the operation time is saved.

[0123] Understandably, the degree of bending of the sheath assembly 400 is related to the proximal movement distance of the traction rope 800. Therefore, the degree of bending of the sheath assembly 400 can be precisely controlled by the second drive assembly 600 to obtain a better puncture angle.

[0124] It should be noted that the second drive assembly can be configured in various structural forms. For example, in some feasible embodiments, the second drive assembly includes a cylindrical body (not shown in the figure) rotatably disposed within the accommodating cavity and a handle (not shown in the figure) located outside the accommodating cavity capable of driving the cylindrical body to rotate. The proximal end of the traction rope is wound around the cylindrical body, and the handle drives the cylindrical body to rotate, causing the traction rope to wind around or release from the cylindrical body, thereby adjusting the tension of the traction rope. Understandably, the second drive assembly can also be configured in other forms, as long as it enables the proximal end of the traction rope to move to change the tension of the traction rope.

[0125] In one exemplary implementation, such as Figure 3 and Figure 6As shown, the second drive assembly 600 includes an adjusting nut 610 and an adjusting slider 620. The adjusting nut 610 is rotatably sleeved on the handle housing 100, and the axis of the adjusting nut 610 is parallel to the axis of the handle housing 100. The adjusting slider 620 is slidably disposed in the receiving cavity 110 and has an external thread that mates with the adjusting nut 610. The handle housing 100 has at least one guide through groove 103, and the internal thread of the adjusting nut 610 and the external thread of the adjusting slider 620 engage through the guide through groove 103. In this embodiment, the axes of the adjusting nut 610 and the adjusting slider 620 both overlap with the axis of the handle housing 100. The inner cavity of the adjusting nut 610 has a trapezoidal internal thread that matches and engages with the trapezoidal external thread of the adjusting slider. When the adjusting nut 610 is rotated, the axis of the adjusting slider 620 in the handle housing 100 moves towards the proximal or distal end. When the adjusting slider 620 moves towards the proximal end, the traction rope 800 is tightened, and the sheath assembly 400 bends. When the adjusting slider 620 moves to the distal end, the traction rope 800 is relaxed, and the sheath assembly 400 returns to its straight position.

[0126] In this embodiment, please refer to Figure 2 and Figure 6 As shown, the adjusting slider 620 has a roughly cylindrical outline, and its circumferential wall surface fits against the inner wall surface of the receiving cavity 110 to prevent the adjusting slider 620 from shaking during sliding. The guide through groove 103 extends along the axial direction of the handle housing 100. The outer circumferential surface of the adjusting slider 620 is also provided with a guide boss 621. The external thread of the adjusting slider 620 is provided on the guide boss 621. The guide boss 621 cooperates with the guide through groove 103 to guide the axial sliding. The number of guide bosses 621 must be consistent with the number of guide through grooves 103. In this embodiment, there are two guide through grooves 103, which are symmetrically arranged with the axis of the handle housing 100 as the axis of symmetry.

[0127] Furthermore, such as Figure 3 As shown, to prevent the adjusting nut 610 from moving axially relative to the handle housing 100, one of the outer wall of the handle housing 100 and the inner wall of the adjusting nut 610 are provided with an annular protrusion 104 arranged radially along the handle housing 100, and the other is provided with a first annular groove 611 that mates with the annular protrusion 104. The axial degree of freedom of the adjusting nut 610 is limited by the engagement of the annular protrusion 104 and the first annular groove 611. In this embodiment, the annular protrusion 104 is arranged around the outer circumferential surface of the handle housing 100, and the first annular groove 611 is located on the inner wall surface of the adjusting nut 610.

[0128] In some implementation methods, please refer to Figure 2 and Figure 3As shown, the handle housing 100 has a second annular groove 105 arranged radially along the handle housing 100. An adjusting nut 610 is disposed within the second annular groove 105, with its proximal and distal ends abutting against the two side walls of the second annular groove 105, respectively. On one hand, by placing the adjusting nut 610 within the second annular groove 105, the adjusting nut 610 is lowered as a whole, and its outer circumferential surface is flush with the outer circumferential surface of the handle housing 100, resulting in a compact overall structure and a simpler, flatter appearance for the interventricular septum puncture device. On the other hand, the two side walls of the second annular groove 105 axially limit the adjusting nut 610, thereby restricting its axial degree of freedom. In this embodiment, an annular protrusion 104 is disposed on the bottom wall of the second annular groove 105.

[0129] In some implementations, such as Figure 7 As shown, the adjusting nut 610 has a first scale 612 arranged circumferentially along the adjusting nut 610, and the handle housing 100 has a second scale 106 corresponding to the first scale 612. The alignment relationship between the first scale 612 and the second scale 106 is used to display the bending angle of the sheath assembly 400, so that the operator can easily and intuitively understand the bending angle of the sheath assembly 400 through the first scale 612 and the second scale 106, so as to accurately and quickly adjust the sheath assembly 400 to the required angle and improve surgical efficiency.

[0130] In some embodiments of the present invention, such as Figure 11 and Figure 12 As shown, the sheath assembly 400 includes a liner 410, an insulating layer group 420, an electrode assembly 430, and an electrode lead 440. Specifically, the sheath assembly 400 is tubular in shape, and the liner 410 has a tubular structure. The inner diameter of the liner 410 is the same as the inner diameter of the sheath assembly 400. The liner 410 extends from the distal end to the proximal end of the sheath assembly 400. The liner 410 must be made of an insulating, non-toxic, biocompatible material with a low coefficient of friction, such as polytetrafluoroethylene (PTFE). The liner 410 is fitted onto the puncture needle 700, the insulating layer group 420 is fitted onto the liner 410, the electrode assembly 430 is located on the insulating layer group 420, the distal end of the electrode lead 440 is connected to the electrode assembly 430, and the proximal end of the electrode lead 440 is used for external mapping system equipment. By setting up the electrode assembly 430, the electrical signals acquired by the electrode assembly 430 are processed by the mapping system equipment, so that the sheath assembly 400 can be visualized in the three-dimensional mapping and reconstruction of the heart, so as to be used for zero-radiation interventional diagnosis and treatment.

[0131] In this embodiment, a connector 130 is provided at the proximal end of the handle housing 100. The proximal end of the electrode wire 440 is connected to the connector 130, and the calibration system equipment can quickly establish a connection with the electrode wire 440 through the connector 130.

[0132] In one exemplary implementation, such as Figure 11As shown, the insulating layer group 420 includes a first insulating layer 421, a second insulating layer 422, and a third insulating layer 423. The electrode assembly 430 includes a first electrode 431 and a second electrode 432. The first electrode 431 has a tubular structure, and its inner diameter is larger than the outer diameter of the inner liner 410. The first electrode 431 is fitted over the inner liner 410, and its distal end is at a first preset distance from the distal end of the sheath assembly 400. In this embodiment, the first preset distance is set to 5 mm. The proximal end of the first electrode 431 is flush with the proximal end of the inner liner 410. The first insulating layer 421 is fitted over the inner liner 410, and its distal end is flush with the inner liner 410. The proximal end of the first insulating layer 421 abuts against the distal end of the first electrode 431. The distal end of the first electrode 431 has a first boss structure 4311, and the outer peripheral surface of the first boss structure 4311 constitutes the outer peripheral surface of the sheath assembly 400. The second insulating layer 422 is fitted over the first electrode 431. The distal end of the second insulating layer 422 begins at the proximal end of the first boss structure 4311, and the proximal end of the second insulating layer 422 is flush with the proximal end of the inner liner 410. The distal end of the second insulating layer 422 is provided with a second boss structure 4221, which is adjacent to the first boss structure 4311. The outer peripheral surface of the second boss structure 4221 constitutes the outer peripheral surface of the sheath assembly 400. The second electrode 432 is tubular and fitted over the second insulating layer 422. The distal end of the second electrode 432 abuts against the proximal end of the second boss structure 4221, and the proximal end of the second electrode 432 is flush with the proximal end of the inner liner 410. The proximal end of the second electrode 432 is provided with a third boss structure 4321, which is adjacent to the second boss structure 4221. The outer peripheral surface of the third boss structure 4321 constitutes the outer peripheral surface of the sheath assembly 400. The third insulating layer 423 is sleeved outside the second electrode 432. The distal end of the third insulating layer 423 abuts against the proximal end of the third boss structure 4321, and the proximal end of the third insulating layer 423 is flush with the proximal end of the inner liner 410. The axial length of the first boss structure 4311 is approximately 5 mm, the axial length of the second boss structure 4221 is approximately 10 mm, and the axial length of the third boss structure 4321 is approximately 5 mm. Electrode wires 440 are welded to the proximal ends of the first electrode 431 and the second electrode 432 respectively and connected to the external calibration system equipment. The electrode wires 440 are used to conduct electrical signals. The first electrode 431 and the second electrode 432 are made of conductive materials; their materials and structures can be the same or different, and they can be made of braided mesh or spring structures. The first electrode 431 and the second electrode 432 are separated by the second insulating layer 422, which allows them to communicate without interfering with each other, improving the stability of electrical signal transmission. Furthermore, the double-layer electrode structure enhances the rigidity of the sheath assembly 400, preventing bending in the middle section of the sheath assembly 400. The insulating layer 420 must be made of insulating, non-toxic, and biocompatible materials, such as polyether block polyamide (Pebax).The thickness of each part can be adjusted to make the outer diameter of the sheath assembly 400 uniform and without steps.

[0133] In another exemplary implementation, such as Figure 12 As shown, the insulating layer assembly 420 includes a support layer 424 and an insulating layer 425. Both the support layer 424 and the insulating layer 425 are tubular structures. The inner diameter of the support layer 424 is larger than the outer diameter of the liner 410 and is fitted over the outer layer of the liner 410. A second preset distance is provided between the distal end of the support layer 424 and the distal end of the liner 410. In this embodiment, the length of the second preset distance is set to 5 mm. The proximal end of the support layer 424 is flush with the proximal end of the liner 410. The support layer 424 is mainly used to improve the rigidity of the sheath assembly 400 and prevent the middle section of the sheath assembly 400 from bending. The distal end of the insulating layer 425 is flush with the distal end of the liner 410, and the proximal end of the insulating layer 425 is flush with the proximal end of the liner 410. The insulating layer 425 is fitted over the outer layer of the support layer 424. Electrode assembly 430 includes a first electrode 431 and a second electrode 432, both of which are annular. Both electrodes 431 and 432 are sleeved outside an insulating layer 425 and are spaced apart. The distal end of electrode wire 440 is encapsulated within the insulating layer 425 and welded to the inner circumferential surfaces of the first electrode 431 and the second electrode 432, respectively. The proximal end of electrode wire 440 extends from the proximal end of the insulating layer 425 and is connected to a calibration system device to conduct electrical signals.

[0134] It should be noted that in this embodiment, please refer to... Figure 3 , Figure 4 and Figure 6As shown, the first linkage component 310, the first drive component 200, the second linkage component 320, and the second drive component 600 are arranged sequentially from the proximal end to the distal end along the axial direction of the handle housing 100. Among the first slider 312, the second slider 322, and the adjusting slider 620, the first slider 312 is positioned closer to the proximal end, the adjusting slider 620 is positioned closer to the distal end, and the second slider 322 is located between the adjusting slider 620 and the first slider 312. A first through hole 622 is provided on the adjusting slider 620. A second through hole 3223 is provided on the second slider 322, and a stepped structure 32231 is provided on the inner wall of the second through hole 3223. A third through hole 3123 is provided on the first slider 312. The axes of the first through hole 622, the second through hole 3223, and the third through hole 3123 all overlap with the axis of the handle housing 100. The first through hole 622 is used to avoid the sheath assembly 400, allowing the proximal end of the sheath assembly 400 to pass through the first through hole 622 and be connected and fixed to the stepped structure 32231 of the second through hole 3223. The second through hole 3223 is used to avoid the puncture needle 700, allowing the proximal end of the puncture needle 700 to pass through the second through hole 3223 and extend to the third through hole 3123 and be fixed inside the third through hole 3123. The first sliding member has an extension rod 3224 on its proximal side. A third through hole 3123 extends from the first sliding member 312 to the extension rod 3224, and the proximal end of the third through hole 3123 forms an opening at the proximal end of the extension rod 3224. The third through hole 3123 communicates with the inner cavity of the puncture needle 700 to establish a guidewire passage, allowing the guidewire to enter from the distal end of the puncture needle 700 and exit through the proximal end of the third through hole 3123. A Luer connector 3225 is also provided on the extension rod 3224. The inner hole of the Luer connector 3225 intersects with the third through hole 3123, facilitating the connection of external instruments for procedures such as air venting and blood aspiration during the operation.

[0135] Implementation Method 2

[0136] The sheath assembly 400, puncture needle 700, handle housing 100, and second drive assembly 600 in this embodiment are basically the same in structure as those in Embodiment 1. The difference lies in the structure of the first drive assembly 200, linkage mechanism 300, and clutch assembly 500. The differences between Embodiment 2 and Embodiment 1 will be described below. The similarities or similarities between Embodiment 2 and Embodiment 1 will not be repeated here.

[0137] In this embodiment, the linkage mechanism 300 is a slider mechanism with two cranks 330 arranged in opposite directions. By converting the rotation of the cranks 330 into the linear motion of the sliders, the first slider 312 is connected as one of the sliders and the second slider 322 is connected as a slider, so as to realize the opposite movement of the first slider 312 and the second slider 322 by driving the linkage of the two connecting rods.

[0138] In detail, such as Figure 13 As shown, the linkage structure includes a crank 330, a first connecting rod 340, a second connecting rod 350, a first sliding member 312, and a second sliding member 322. Both the first sliding member 312 and the second sliding member 322 are slidably engaged with the inner wall of the handle housing 100, allowing both to slide relative to the handle housing 100 along its axial direction. The crank 330 is rotatably disposed within the receiving cavity 110. The crank 330 includes a centrally symmetrical first hinge portion 331 and a second hinge portion 332. One end of the first connecting rod 340 is hinged to the first hinge portion 331, and the other end is hinged to the first sliding member 312. One end of the second connecting rod 350 is hinged to the second hinge portion 332, and the other end is hinged to the second sliding member 322. The first drive assembly 200 includes a transmission rod (not shown) connected to the crank 330, and an adjustment knob 220 connected to the transmission rod and located outside the receiving cavity 110. In this embodiment, the first hinge portion 331, the first connecting rod 340, and the first slider 312 constitute one crank 330 slider mechanism, and the second hinge portion 332, the second connecting rod 350, and the second slider 322 constitute the other crank 330 slider mechanism. The two crank 330 slider mechanisms are centrally symmetrically arranged about the rotation axis of the crank 330, such that when the crank 330 rotates, the first slider 312 and the second slider 322 move in opposite directions.

[0139] In this embodiment, the clutch assembly 500 is a connector that can be detachably connected to the second slider 322 and the handle housing 100, respectively, to change the relative state between the second slider 322 and the handle housing 100. Furthermore, the handle housing 100 has an elongated hole (not shown in the figure) extending along its own axial direction, through which the transmission rod extends from the elongated hole into the receiving cavity 110 and can slide within the elongated hole. When the puncture needle 700 performs the puncture action, the connecting parts are all connected to the second sliding member 322 and the handle housing 100. The second sliding member 322 is stationary relative to the handle housing 100. When the adjustment knob 220 is rotated, the second sliding member 322 remains stationary. The crank 330 and the first sliding member 312 can slide along the axial direction of the handle housing 100 to realize the opposite movement of the first sliding member 312 and the second sliding member 322. Thus, while the sheath assembly 400 remains stationary, the puncture needle 700 moves distally and extends beyond the distal end of the sheath assembly 400 to complete the puncture action.

[0140] When the puncture needle 700 performs the insertion and retraction operation, the connector is detached from the second slider 322 and the handle housing 100, allowing the second slider 322 to move relative to the handle housing 100. Reversing the adjustment knob 220 allows both the first slider 312 and the second slider 322 to move relative to the handle housing 100, achieving opposite movements of the first slider 312 and the second slider 322. This allows the puncture needle 700 to move proximally to complete the retraction operation while the sheath assembly 400 continues to extend distally, simultaneously completing the pore-expanding operation of the sheath assembly.

[0141] It should be noted that this embodiment is only one feasible way of the linkage mechanism 300. According to actual needs, the linkage structure can also be set in other forms. As long as the linkage mechanism 300 includes two modules or structures that move in opposite directions and are respectively connected to the proximal end of the puncture needle 700 and the proximal end of the sheath assembly 400, and can realize the movement of the proximal end of the sheath assembly 400 and the proximal end of the puncture needle 700 in opposite directions, it is within the protection scope of this invention.

[0142] The simplified surgical procedure of this invention is as follows: A mapping system device is connected to the connector 130. The mapping system device generates a low-energy current that is transmitted to the electrode assembly 430. After signal transmission and signal recovery calculation, the sheath assembly 400 can be visualized in the three-dimensionally mapped and reconstructed heart. Therefore, the sheath assembly 400 can be used without radiation. After the sheath assembly 400 is delivered to the right atrium via a guidewire, the adjusting nut 610 on the adjusting handle is rotated to bend the distal end of the sheath assembly 400 to the ideal angle and locate the interatrial septum. At this time, the puncture needle 700 is in a non-extruded state. The position of the positioning knob 520 is adjusted so that the mating part 510 and the mating part 3221 are in the first mating state. Then, the adjusting knob 220 is rotated, and the position of the sheath assembly 400 remains unchanged. The puncture needle 700 extends out of the sheath and rests on the interatrial septum tissue. Then, the adjusting knob 220 is rotated to allow the puncture needle 700 to pierce the interatrial septum and enter the left atrium. Pull out the positioning button 520 and rotate it 90° to put the mating part 510 and the mating part 3221 into the second mating state. Then release the positioning button 520 into the second limiting groove 102 and reverse the adjustment knob 220. This will allow the puncture needle 700 to retract (i.e. move to the proximal side) and the sheath to extend (i.e. move to the distal side). The head of the puncture needle 700 will be completely retracted into the sheath, and the needle tip will not come into contact with the heart wall, thus completely avoiding the risk of puncturing the heart wall.

[0143] The transseptal puncture device proposed in this invention has the following advantages:

[0144] First, the transseptal puncture device integrates the sheath assembly and the puncture needle in its structure, reducing the need for subsequent separate assembly of the puncture needle. This significantly reduces the risk of the puncture needle scraping against the inner wall of the sheath assembly and generating debris. Simultaneously, the puncture needle and sheath assembly can move in opposite directions, allowing for rapid needle retraction and rapid puncture dilation in a single operation.

[0145] Secondly, by using gear meshing and thread adjustment, the extension position and distance of the puncture needle can be made precise and controllable. This avoids the situation in existing equipment where, when the doctor manually pushes the puncture needle, due to inertia, after passing through the interatrial septum and entering the left atrium, the puncture needle continues to move forward and pierces the left atrial wall, causing cardiac tamponade, or piercing the aorta and causing serious complications that endanger the patient.

[0146] Third, the bending angle of the sheath assembly can be precisely adjusted by the traction rope through the second drive component, thereby adjusting the puncture angle of the puncture needle. There is no need to remove the puncture needle and reshape the angle of the puncture needle, which improves the positional accuracy of the puncture needle and saves surgical time.

[0147] Fourth, the sheath assembly can be visualized in three-dimensional mapping and reconstruction of the heart, making it suitable for zero-radiation interventional diagnostic and therapeutic procedures, and enabling physicians to accurately determine whether the sheath assembly passes through the interatrial septum and the depth to which it passes through the interatrial septum.

[0148] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. An atrial septal puncture device, characterized by, The transseptal puncture device includes: A handle housing having a receiving cavity; A sheath assembly, the proximal end of which extends into the receiving cavity of the handle housing; A puncture needle is inserted into the sheath assembly, and the puncture needle has a first state that is relatively fixed relative to the sheath assembly and a second state that moves axially relative to the sheath assembly under the drive of an external force. A linkage mechanism is movably disposed in the receiving cavity, and the linkage mechanism includes a first linkage component connected to the puncture needle; A first drive assembly is disposed on the handle housing and passes through the handle housing, connected to the first linkage assembly; an external force is applied to the first drive assembly, which drives the first linkage assembly to move the puncture needle connected to the first linkage assembly axially relative to the sheath assembly, thereby allowing the distal end of the puncture needle to extend beyond the distal end of the sheath assembly; the linkage mechanism further includes: The second linkage component is connected to the first drive component, and both the first linkage component and the second linkage component are capable of moving within the accommodating cavity; The proximal end of the sheath assembly is connected to the second linkage assembly, and the proximal end of the puncture needle extends from the proximal end of the sheath assembly and is connected to the first linkage assembly. The first drive assembly drives the first linkage assembly and the second linkage assembly to move the puncture needle and the sheath assembly in opposite directions simultaneously. The simultaneous reverse movement of the puncture needle and the sheath assembly includes: the proximal end of the sheath assembly and the proximal end of the puncture needle moving away from each other, and the proximal end of the sheath assembly and the proximal end of the puncture needle moving closer to each other.

2. The atrial septostomy device of claim 1, wherein, The transseptal puncture device also includes: A clutch assembly is disposed on the handle housing and passes through the handle housing to cooperate with the second linkage assembly; The clutch assembly and the second linkage assembly have a first engagement state and a second engagement state. In the first engaged state, the second linkage component is separated from the sheath assembly; In the second engagement state, the second linkage component is connected to the sheath assembly.

3. The transseptal puncture device according to claim 2, characterized in that, The first linkage component includes: The first transmission component is connected to the first drive component in a transmission manner; The first sliding member slides in cooperation with the inner wall of the accommodating cavity. The first sliding member connects the first transmission assembly and the proximal end of the puncture needle, so that the first sliding member can be driven to slide by the first transmission assembly, thereby driving the puncture needle connected to the first sliding member to move axially. The second linkage component includes: The second transmission component is connected to the first drive component in a transmission manner; The second sliding member slides against the inner wall of the accommodating cavity. The second sliding member connects the second transmission assembly and the proximal end of the sheath assembly, so that the second sliding member can be driven to slide through the second transmission assembly, thereby driving the sheath assembly connected to the second sliding member to move axially. The first driving component drives the first transmission component and the second transmission component in a coordinated manner to drive the first slider and the second slider to move in opposite directions simultaneously. The clutch assembly has a mating member, and the second sliding member has a mating part that mates with the mating member. The mating member and the mating part mate to achieve the first mating state and the second mating state.

4. The atrial septal puncture device according to claim 3, characterized in that, The first drive component includes a drive gear, and the first slider is provided with a first threaded hole; The first transmission assembly includes a first driven gear and a first screw connected together. The first screw passes through and engages with the first threaded hole, and both ends of the first screw are rotatably connected to the handle housing. The second transmission assembly includes a second driven gear, a second screw connected to the second driven gear, and a transmission nut sleeved on the second screw. The two ends of the second screw are rotatably connected to the handle housing. In the first mating state, the transmission nut is separated from the mating part by the mating component; In the second mating state, the transmission nut is connected to the mating part through the mating component.

5. The atrial septal puncture device according to claim 4, characterized in that, The mating part is a deformable claw structure, and the claw structure is provided with mating holes; The mating part has a pin portion that engages with the mating hole; In the first mating state, the pin is inserted into the mating hole and opens the claw structure, so that the claw structure is separated from the transmission nut; In the second mating state, the pin portion separates from the mating hole, and the claw structure clamps the transmission nut.

6. The atrial septal puncture device according to claim 4, characterized in that, The ratio of the number of teeth of the first driven gear to the number of teeth of the second driven gear is greater than or equal to 1; and / or The ratio of the pitch of the second screw to the pitch of the first screw is greater than or equal to 1.

7. The atrial septal puncture device according to claim 4, characterized in that, The clutch assembly also includes a positioning button, a connecting rod, and an elastic element. The positioning button is located outside the receiving cavity. One end of the connecting rod is connected to the positioning button, and the other end of the connecting rod extends into the receiving cavity and is connected to the mating member. The elastic element is sleeved on the connecting rod, and one end of the elastic element abuts against the mating member, while the other end of the elastic element abuts against the inner wall of the receiving cavity. In the first mating state, the elastic member applies an elastic force toward the mating part to the mating member.

8. The transseptal puncture device according to claim 7, characterized in that, The outer wall of the handle housing is provided with a first limiting groove and a second limiting groove recessed toward the mating part. The position of the positioning button can be switched between the first limiting groove and the second limiting groove. The depth of the first limiting groove is greater than the depth of the second limiting groove. In the first engagement state, the positioning button is located in the first limiting groove, and in the second engagement state, the positioning button is located in the second limiting groove.

9. The atrial septal puncture device according to any one of claims 1 to 8, characterized in that, The sheath assembly includes: The inner liner is fitted over the outside of the puncture needle; An insulating layer assembly is fitted over the outer side of the inner liner; Electrode assembly, disposed on the insulating layer group; An electrode wire, the distal end of which is connected to the electrode assembly, and the proximal end of which is used for connecting to an external calibration system device.

10. The atrial septal puncture device according to claim 9, characterized in that, The insulating layer group includes a first insulating layer, a second insulating layer, and a third insulating layer; The electrode assembly includes a first electrode and a second electrode; The first electrode is sleeved outside the inner liner, the second insulating layer is sleeved outside the first electrode, the second electrode is sleeved outside the second insulating layer, the third insulating layer is sleeved outside the second electrode, the first insulating layer is sleeved outside the inner liner, and the distal end of the first insulating layer is flush with the inner liner, and the proximal end of the first insulating layer abuts against the distal end of the first electrode.

11. The atrial septal puncture device according to claim 9, characterized in that, The insulating layer assembly includes a support layer and an insulating layer, wherein the support layer is sleeved outside the inner liner and the insulating layer is sleeved outside the support layer; The electrode assembly includes a first electrode and a second electrode, both of which are sleeved outside the insulating layer and are spaced apart. The distal end of the electrode wire is encapsulated within the insulating layer, and the proximal end of the electrode wire extends from the proximal end of the insulating layer.

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