An atrial septostomy system

Abstract

This application relates to an atrial septal puncture system, belonging to the field of medical device technology. The atrial septal puncture system includes a delivery sheath assembly, a dilator assembly, and a puncture guidewire. The dilator assembly includes a dilator, a puncture needle, and a control handle. This application combines the delivery sheath assembly, dilator assembly, and puncture guidewire into an atrial septal puncture system, making the puncture operation more convenient and safer, eliminating the need for frequent exchanges of the puncture guidewire and puncture needle during the puncture procedure. The control handle in the dilator assembly includes a moving part and a limiting part. The moving part is fixedly connected to the proximal end of the puncture needle and is used to drive the puncture needle to move along its axial direction, facilitating user control of the puncture needle. This application provides a limiting step on the outer wall of the moving part, with an axial distance of 0.5-10 mm between the proximal end of the limiting part and the limiting step. This design limits the distance the puncture needle extends beyond the dilator, helping to ensure the safety of the puncture operation.

Description

Technical Field

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

[0002] With the popularization of electrophysiology and structural heart disease surgery, atrial septal puncture has become a key technique in interventional cardiac treatment. Atrial septal puncture is suitable for diseases requiring left atrial access, such as atrial fibrillation radiofrequency ablation, left atrial appendage occlusion, mitral valve disease, interventional treatment of congenital heart disease, and percutaneous left ventricular assist device implantation.

[0003] Currently, atrial septal puncture is typically performed using mechanical instruments. Most existing devices consist of a guide sheath, a dilator, and a puncture needle. During the procedure, the operator inserts the distal ends of the guide sheath and dilator into the heart along a guidewire. Once the distal end of the dilator reaches the predetermined position, the guidewire is withdrawn, and the puncture needle is inserted into the dilator. The distal end of the puncture needle is designed with a needle-like structure to facilitate manipulation, allowing the distal end to extend beyond the dilator and puncture the atrial septum, thus achieving atrial septal puncture. However, existing puncture devices are inconvenient to operate, involve significant difficulty, and require frequent exchanges of the puncture needle and guidewire during the procedure.

[0004] In view of the above, this application is hereby submitted. Summary of the Invention

[0005] The purpose of this application is to overcome the shortcomings of the prior art and provide a transseptal puncture system.

[0006] To achieve the above objectives, the technical solution adopted in this application is as follows:

[0007] A transseptal puncture system includes a delivery sheath assembly, a dilator assembly, and a puncture guidewire.

[0008] The delivery sheath assembly includes a delivery sheath tube, a bending mechanism, and a delivery handle. The interior of the delivery sheath tube has a central chamber that connects its distal and proximal ends along its axial direction.

[0009] The dilator assembly includes a dilator, a puncture needle, and a control handle. The dilator is a hollow tubular structure and is inserted into the central cavity of the delivery sheath. The puncture needle is inserted into the dilator, and the proximal end of the puncture needle is fixedly connected to the control handle. The control handle includes a moving part and a limiting part. The moving part is fixedly connected to the proximal end of the puncture needle and is used to drive the puncture needle to move along its axial direction. The outer wall of the moving part is provided with a limiting step. The axial distance between the proximal end of the limiting part and the limiting step is D1, and D1 limits the distance by which the puncture needle extends out of the dilator to 0.5-10 mm.

[0010] The puncture guide wire is inserted into the inner cavity of the puncture needle, and an electrode puncture head is provided at its distal end.

[0011] Preferably, the bending mechanism includes a bending knob and a pull line. The distal end of the pull line is fixedly connected to the inside of the delivery sheath near its distal end, and the proximal end of the pull line is connected to the bending mechanism. The bending mechanism pulls the pull line by rotating the knob clockwise or counterclockwise, so that at least one side of the distal end of the delivery sheath is bent by not less than 90°.

[0012] More preferably, the bending mechanism includes a limiting sleeve, a transmission block, and a transmission rod. The limiting sleeve is fixedly connected to the bending knob. The limiting sleeve is coaxially disposed at the distal end of the conveying handle and rotatably connected to the conveying handle. The transmission block is hollow and sleeved on the transmission rod. The inner wall of the transmission block is fixedly connected to the outer wall of the transmission rod. The transmission rod has a hollow structure and is located inside the conveying handle and sleeved on the conveying sheath. The proximal end of the pull wire is connected to the transmission rod.

[0013] More preferably, the transmission rod includes a sliding sleeve portion and a threaded portion connected sequentially from its proximal end to its distal end. The outer wall of the sliding sleeve portion slides in engagement with the inner wall of the conveying handle, and the outer wall of the threaded portion is provided with threads. The threaded portion is threaded in engagement with the transmission block.

[0014] Preferably, the control handle includes an expander fixing member and a handle housing, the expander fixing member is hollow, and the distal end of the expander fixing member is fixedly connected to the proximal end of the expander; the handle housing is hollow and sleeved on the outside of the moving part.

[0015] More preferably, the limiting member is located between the moving member and the dilator fixing member. The limiting member has a hollow structure and is sleeved on the puncture needle. The inner wall of the limiting member slides with or has a gap with the outer wall of the puncture needle. The moving member and the limiting member are connected by a spring.

[0016] More preferably, the proximal port of the limiting member forms a limiting structure with the limiting step; when the spring member is in its natural state, the distal end of the puncture needle is located inside the dilator, and the axial distance between the proximal end of the limiting member and the limiting step is D1.

[0017] The handle housing is provided with a limiting hole, which is located between the limiting step and the proximal end of the limiting member.

[0018] More preferably, the distal end of the limiting member is sealed to the dilator fixing member by a first sealing member, the first sealing member having a through hole adapted to the puncture needle.

[0019] Preferably, the handle housing is provided with a slot, and the outer wall of the moving part is provided with a pushing part. One end of the pushing part passes through the slot and protrudes outside the handle housing, and the outer wall of the pushing part slides in cooperation with the inner wall of the slot.

[0020] More preferably, the moving part is provided with a fluid channel communicating with the inner cavity of the puncture needle, the fluid channel extending to the pushing part and connected to a second three-way valve through a conduit.

[0021] Preferably, the inner cavity of the puncture needle forms a first fluid channel, the outer wall of the puncture needle and the inner wall of the dilator form a second fluid channel, the outer wall of the puncture needle is provided with a connecting hole, the first fluid channel and the second fluid channel are connected through the connecting hole, the puncture needle moves axially under the drive of the control handle, and drives the connecting hole and the distal port of the first fluid channel to move synchronously.

[0022] Preferably, the expander assembly further includes a guide wire connector, which has a hollow structure and is connected and communicates with the proximal end of the moving member;

[0023] The guide wire connector and the proximal end of the moving part are sealed together by a second seal, the second seal having a through hole adapted to the puncture guide wire.

[0024] Preferably, the puncture needle includes a needle tip, a flexible connecting needle tube, and a needle tube body connected sequentially from its distal end to its proximal end.

[0025] Preferably, the inner wall of the dilator is provided with a first step, and the outer wall of the puncture needle is provided with a second step. The first step is located between the second step and the tip of the puncture needle, and the first step and the second step form a limiting structure.

[0026] Preferably, the puncture guidewire includes a mandrel and an insulating tube. The distal end of the mandrel is connected to an electrode puncture head. The distal end of the mandrel has a tapered section. A spring coil is sleeved on the outside of the tapered section. The spring coil covers the tapered section and forms a distal guidewire segment of equal diameter.

[0027] Preferably, the puncture guidewire includes a monitoring electrode for detecting potential information at the location of the fossa ovalis.

[0028] Compared with the prior art, the beneficial effects of this application are as follows:

[0029] This application combines the delivery sheath assembly, the dilator assembly, and the puncture guidewire into a transseptal puncture system, which makes the puncture operation more convenient and safer, and eliminates the need for frequent exchange of the puncture guidewire and puncture needle during the puncture operation.

[0030] The control handle of the dilator assembly described in this application includes a moving part and a limiting part. The moving part is fixedly connected to the proximal end of the puncture needle and is used to drive the puncture needle to move along its axial direction. The control handle can control the distal end of the puncture needle to extend or retract from the distal end of the dilator, making it convenient for the user to operate the puncture needle.

[0031] This application provides a limiting step on the outer wall of the moving part, and the axial distance between the proximal end of the limiting part and the limiting step is 0.5-10mm. This design can limit the distance that the puncture needle extends out of the dilator, which helps to ensure the safety of the puncture operation. Attached Figure Description

[0032] Figure 1 A perspective view of the intercom puncture system provided in this application;

[0033] Figure 2 A cross-sectional view of the delivery sheath assembly provided in this application;

[0034] Figure 3 A cross-sectional view of the expander component provided in this application;

[0035] Figure 4 A perspective view of the control handle provided in this application;

[0036] Figure 5 A schematic diagram of the dilator and puncture needle provided in this application;

[0037] Figure 6 for Figure 5 Enlarged view of section A;

[0038] Figure 7 for Figure 5 Enlarged view of section B;

[0039] Figure 8 This is a schematic diagram of the puncture needle provided in this application;

[0040] Figure 9 This is a schematic diagram of the puncture guidewire provided in this application;

[0041] Figure 10 for Figure 9 Enlarged view of section C.

[0042] In the diagram, 1-delivery sheath assembly, 11-delivery sheath tube, 12-delivery handle, 13-adjustment mechanism, 131-adjustment knob, 132-limiting sleeve, 133-transmission block, 134-transmission rod, 135-slider, 134-transmission rod, 1341-threaded part, 1342-sliding sleeve part, 14-sheath, 2-expander assembly, 21-expander, 211-inner layer, 212-middle layer, 213-outer layer, 214-first step, 22-puncture needle, 221-needle tube body, 222-needle tip, 223-flexible connecting needle tube, 224-second step, 23-control handle, 231-expander fixing component, 232-handle 2321-Groove, 2322-Limiting Hole, 233-Moving Component, 2331-Limiting Step, 2332-First Channel, 2333-Second Channel, 2334-Mounting Groove, 2335-Third Channel, 2336-Pushing Part, 234-Limiting Component, 2341-Through Groove, 235-Sliding Structure, 2351-Slider, 2352-Groove, 236-Spring Component, 237-First Seal, 238-Second Seal, 24-Guide Wire Connector, 251-First Fluid Channel, 252-Second Fluid Channel, 3-Piercing Guide Wire, 31-Mandrel, 32-Insulating Tube, 33-Electrode Puncture Head, 34-Spring Coil. Detailed Implementation

[0043] To make the objectives, advantages, and features of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, used only to facilitate and clearly illustrate the purpose of the embodiments of this application. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and sometimes use different scales.

[0044] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the specification of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application.

[0045] It is understood that spatial relation terms such as "below," "under," "below," "below," "above," "over," etc., can be used here to describe the relationship between one element or feature shown in the figure and other elements or features. It should be understood that, in addition to the orientation shown in the figure, spatial relation terms also include different orientations of the device in use and operation. For example, if the device in the figure is flipped, the element or feature described as "below" or "under" or "below" of the other element or feature will be oriented "over" the other element or feature. Therefore, the exemplary terms "below" and "under" can include both upper and lower orientations. Furthermore, the device may also include other orientations (e.g., rotated 90° or other orientations), and the spatial descriptive terms used herein will be interpreted accordingly.

[0046] It should be noted that when one element is considered to be "connected" to another element, it can be directly connected to the other element or connected to the other element through an intermediary element. In the following embodiments, "connection" should be understood as "electrical connection," "communication connection," etc., if the connected circuits, modules, units, etc., have the transmission of electrical signals or data between them.

[0047] It should be noted that the singular forms of “a,” “one,” and “the” can also include the plural forms, unless the context clearly indicates otherwise.

[0048] It should also be understood that the terms “including / comprise” or “have” specify the presence of the stated features, wholes, steps, operations, components, parts, or combinations thereof, but do not preclude the possibility of the presence or addition of one or more other features, wholes, steps, operations, components, parts, or combinations thereof.

[0049] It should also be understood that, unless otherwise specified or indicated, the terms “first,” “second,” “third,” etc., in the specification are used only to distinguish the various components, elements, and steps in the specification, and not to indicate the logical or sequential relationships between the various components, elements, and steps.

[0050] In the description of this application, it should be noted that the term "distal" usually refers to the end of the medical device that first enters the patient's body during normal operation, while "proximal" usually refers to the end of the medical device that is closer to the operator during normal operation.

[0051] Please see Figures 1-10 This application provides a transseptal puncture system, which includes a delivery sheath assembly 1, a dilator assembly 2, and a puncture guidewire 3.

[0052] The delivery sheath assembly 1 includes a delivery sheath tube 11 and a delivery handle 12. The interior of the delivery sheath tube 11 has a central chamber 111 that connects its distal and proximal ends along its axial direction.

[0053] The expander assembly 2 includes an expander 21 and a control handle 23. The expander 21 is a hollow tubular structure extending from its proximal end to its distal end. The distal end of the expander 21 can extend along the central chamber of the delivery sheath 11 and protrude from the delivery sheath 11. The proximal end of the expander 21 is fixedly connected to the control handle 23.

[0054] The puncture needle 22 is a hollow tubular structure. The distal end of the puncture needle 22 extends inside the dilator 21, and the proximal end of the puncture needle 22 is located outside the dilator 21.

[0055] The control handle 23 is used to move the puncture needle 22 along its axial direction and to extend or retract the distal end of the puncture needle 22 from the distal end of the dilator 21.

[0056] The puncture guide wire 3 extends along the inside of the puncture needle 3 and protrudes from the distal end of the puncture needle 3.

[0057] See Figure 1 and Figure 2 In some embodiments, the delivery sheath assembly 1 includes a bending mechanism 13, which is used to pull the pull wire to bend the delivery sheath 11. The bending mechanism 13 includes a bending knob 131 disposed on the delivery handle 12. The distal end of the delivery sheath 11 is connected to the distal end of the pull wire, and the proximal end of the pull wire is connected to the bending mechanism 13. The bending knob 131 is fixedly connected to the pull wire. By rotating the bending knob 131 clockwise or counterclockwise, the bending of the delivery sheath 11 is controlled. The delivery sheath 11 can be configured for bidirectional or unidirectional bending, with a bending angle greater than or equal to 90°. Further, the bending angles on both sides can be set to 180°, or one side can be bent at 90° and the other side at 180°. In some embodiments, a tactile feedback mechanism is further provided on the bending knob 131, such as... Figure 1 The grooved pattern shown can be a single shape or a combination of shapes. This tactile feedback mechanism helps doctors quickly locate the bending knob 131, improving operational efficiency. Furthermore, it increases the contact friction of the knob, preventing slippage during operation and enhancing safety.

[0058] See appendix Figure 2In one embodiment, the bending mechanism 13 includes a bending knob 131, a limiting sleeve 132, a transmission block 133, and a transmission rod 134. The bending knob 131 is located on the outside of the conveying sheath 11 and is connected to the limiting sleeve 132. The limiting sleeve 132 is coaxially located at the far end of the conveying handle 12 and is rotatably connected to the conveying handle 12. The transmission block 133 is hollow and is sleeved on the transmission rod 134. The inner wall of the transmission block 133 is threadedly fixedly connected to the outer wall of the transmission rod 134. The transmission rod 131 is hollow and is located inside the conveying handle 12 and sleeved on the conveying sheath 11. The proximal end of the pull wire is connected to the transmission rod 134.

[0059] Furthermore, the transmission rod 134 includes a sliding sleeve portion 1341 and a threaded portion 1342 connected sequentially from its proximal end to its distal end. The outer wall of the sliding sleeve portion 1341 slides in engagement with the inner wall of the conveying handle 12, and the outer wall of the threaded portion 1342 is provided with threads. The threaded portion 1342 is threaded in engagement with the transmission block 133.

[0060] Since the bending knob 131 is fixedly connected to the limiting sleeve 132, and the limiting sleeve 132 is fixedly connected to the transmission block 133, when the bending knob 131 is rotated, the limiting sleeve 132 and the transmission block 133 rotate accordingly. Under the action of the threaded fixed connection, the transmission rod 134 reciprocates along its axial direction. Therefore, in this embodiment, the operator can hold the conveying handle 12 and directly rotate the bending knob 131 to drive the limiting sleeve 132 and the transmission block 133 to rotate relative to the conveying handle 12, thereby causing the transmission rod 134 and the slider 135 to move relative to the conveying handle 12, thereby pulling the pull line to bend the conveying sheath 11, which is convenient to operate.

[0061] Furthermore, one of the outer wall of the limiting sleeve 132 and the inner wall of the conveying handle 12 is provided with a limiting protrusion, and the other is provided with an annular groove that matches the limiting protrusion, so that the limiting sleeve 132 can rotate relative to the conveying handle 12, but the limiting sleeve 132 is restricted from moving axially relative to the conveying handle 12.

[0062] Furthermore, the delivery sheath assembly 1 also includes a sheath 14, the proximal end of which is located within the bending knob 131, and the distal end of which extends from the distal end of the bending knob 131.

[0063] The sheath 14 can be made of rubber or silicone. The sheath 14 is designed to prevent the delivery sheath 11 from being directly contacted with the bending knob 131 when it is bent, thus avoiding damage to the delivery sheath 11.

[0064] Furthermore, the delivery sheath 11 includes a first tube segment and a second tube segment connected sequentially from its distal end to its proximal end. The hardness of the first tube segment is less than that of the second tube segment, and the distal end of the pull wire is connected to the first tube segment.

[0065] The first pipe section includes an inner pipe and an outer pipe arranged coaxially. The distal end of the inner pipe is fixedly connected to the distal end of the outer pipe to form a closed end. A pull ring is provided in the gap between the inner pipe and the outer pipe. The pull ring is connected to the closed end. The distal end of the pull wire passes through the gap between the inner pipe and the outer pipe and is connected to the pull ring.

[0066] Furthermore, a hemostatic valve 15 is provided at the proximal end of the delivery sheath 11, which communicates with the interior of the delivery sheath 11 to form a central chamber; a communication port is provided on the side wall of the hemostatic valve 15, and the communication port of the hemostatic valve 15 is connected to a first three-way valve through a catheter. The first three-way valve is used to connect a pressure sensor and / or a fluid delivery pump to facilitate fluid aspiration, fluid injection, and pressure monitoring during puncture.

[0067] See Figure 3 and 4 In one embodiment, the control handle 23 includes an expander fixing member 231, a handle housing 232, and a moving member 233;

[0068] The expander fixing member 231 is hollow, and the distal end of the expander fixing member 231 is fixedly connected to the proximal end of the expander 21. The proximal end of the expander fixing member 231 is fixedly connected to the distal end of the handle housing 232.

[0069] The handle housing 232 is hollow and fitted onto the moving part 233. When the doctor operates the instrument, he can control the axial movement of the puncture needle 22 by gripping the handle housing 232 and moving it axially, which facilitates operation and improves surgical efficiency. The inner wall of the handle housing 232 slides with or has a gap with the outer wall of the moving part 233.

[0070] The moving part 233 is fixedly connected to the puncture needle 22, and the moving part 233 is used to drive the puncture needle 22 to move along its axial direction.

[0071] Furthermore, the handle housing 232 is fitted onto the expander fixing member 231 and is fixedly connected to the expander fixing member 231 by threads.

[0072] Furthermore, the inner wall of the expander fixing member 231 is threadedly or bondedly connected to the outer wall of the expander 21.

[0073] Furthermore, the control handle 23 also includes a limiting member 234, located between the moving member 233 and the dilator fixing member 231. The limiting member 234 has a hollow structure and is sleeved on the puncture needle 22. The inner wall of the limiting member 234 slides against or has a gap with the outer wall of the puncture needle 22. The distal end of the moving member 233 is connected to the limiting member 234 via a spring member 236. After puncture, the operator slowly releases the pushing force at the end of the control handle. Under the action of the rebound force of the spring member 236, the moving member 233 moves proximally, causing the distal end of the puncture needle to retract into the dilator, further improving the safety after puncture.

[0074] Furthermore, the outer wall of the moving part 233 is provided with a limiting step 2331, and the proximal port of the limiting part 234 forms a limiting structure with the limiting step 2331.

[0075] When the spring member 236 is in its natural state, the distal end of the puncture needle 22 is located inside the dilator 21, and the axial distance between the limiting step 2331 and the proximal port of the limiting member 234 is D1, where 0.5mm ≤ D1 ≤ 10mm. For example, D1 can be 0.5mm, 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, or any range of two such values.

[0076] More preferably, 3mm≤D1≤7mm. This design ensures that the maximum distance the distal end of the puncture needle 22 extends beyond the dilator 21 during the puncture operation is ≤D1, which can achieve the ideal puncture effect and improve the safety of the puncture operation.

[0077] The handle housing 232 is provided with a limiting hole 2322 that penetrates the handle housing 232, and the limiting hole 2322 is located between the limiting step 2331 and the proximal end of the limiting member 234. When the spring member 236 is in its natural state, the pin is inserted into the limiting hole 2322, and the inserted end of the pin abuts against the limiting step 2331. In this way, the distal end of the puncture needle 22 can be kept inside the dilator 21 when puncture is not required, thereby improving the operational safety of the system.

[0078] Furthermore, the moving part 233 and the limiting part 234 are slidably engaged by at least one sliding structure 235.

[0079] The hollow cavity of the limiting member 234 includes a through groove 2341 adapted to the moving member 233, the distal end of the moving member 233 extends into the through groove 2341, and the spring member 236 is located in the through groove 2341.

[0080] In this application, the sliding structure 235 may include a slider 2351 and a groove 2352.

[0081] For example, slider 2351 is disposed on the outer wall of moving part 233, and groove 2352 is disposed on the inner wall of through groove 2341.

[0082] For example, the groove 2352 is disposed on the outer wall of the moving part 233, and the slider 2351 is disposed on the inner wall of the through groove 2341.

[0083] Furthermore, the expander fixing member 231 is sleeved on the far end of the limiting member 234, and the outer wall of the limiting member 234 is fixedly connected to the inner wall of the expander fixing member 231 by threads.

[0084] Furthermore, the distal end of the limiting member 234 is sealed to the dilator fixing member 231 through the first sealing member 237, which is provided with a through hole adapted to the puncture needle 22. The first sealing member 237 can effectively prevent fluid in the dilator 21 (such as blood flowing into the dilator 21 during puncture) from overflowing into the hollow cavity of the limiting member 234.

[0085] Furthermore, the handle housing 232 is provided with a slot 2321, and the outer wall of the moving part 233 is provided with a pushing part 2336. One end of the pushing part 2336 passes through the slot 2321 and is exposed outside the handle housing 232. The outer wall of the pushing part 2336 slides with the inner wall of the slot 2321 or has a gap.

[0086] Furthermore, the hollow cavity of the moving part 233 includes a first channel 2332, a second channel 2333, and a mounting groove 2334 that are coaxially arranged and connected in sequence. The proximal end of the puncture needle 22 extends into the first channel 2332. The outer wall of the puncture needle 22 is fixedly connected to the inner wall of the first channel 2332 by threads or adhesive. The hollow cavity of the moving part 233 also includes a third channel 2335. One end of the third channel 2335 is connected to the second channel 2333, and the other end of the third channel 2335 is connected to the hollow pushing part 2336. The pushing part 2336 is connected to a second three-way valve through a conduit.

[0087] The push part 2336 can be tilted or perpendicular to the central axis of the handle housing 232.

[0088] In use, the second three-way valve can be connected to a pressure sensor to monitor the internal pressure of the moving part 233. It can also be connected to a fluid delivery pump to inject fluid (such as cold saline, contrast agent, etc.), allowing the fluid to flow through the moving part 233, the puncture needle 22, and the dilator 21 before being ejected from the distal end of the dilator 21. During radiofrequency puncture, the injection of cold saline, ejected from the distal end of the dilator 21, cools the nearby electrode puncture head 33, reducing the risk of scab formation during puncture and improving the safety and success rate of the puncture.

[0089] The inner diameter of the second channel 2333 is larger than the inner diameter of the first channel 2332, and the inner diameter of the second channel 2333 is larger than the inner diameter of the third channel 2335. The second channel 2333 can be one or a combination of funnel-shaped, frustum-shaped, cylindrical, and column-shaped.

[0090] Please see Figures 5-7 In one embodiment, the inner cavity of the puncture needle 22 forms a first fluid channel 251, and the outer wall of the puncture needle 22 forms a second fluid channel 252 between the inner wall of the dilator 21. The puncture needle 22 has a connecting tube section located inside the dilator 21, and the connecting tube section is provided with a plurality of connecting holes at equal intervals along its axial direction. During fluid injection, fluid can enter the second fluid channel 252 through the connecting holes so that fluid can be ejected from the distal end of the dilator 21.

[0091] In some embodiments, the puncture needle 22 moves axially under the drive of the control handle 23, causing the connecting hole and the distal port of the first fluid channel 251 to move synchronously. This allows the distal port of the first fluid channel 251 to be closer to the puncture site than the distal port of the second fluid channel 252, thereby achieving better cooling and imaging effects when contrast agent or cold saline is injected, improving the accuracy of puncture positioning, and reducing thermal damage that may occur during puncture.

[0092] Furthermore, the expander assembly 2 also includes a guide wire connector 24, which has a hollow structure and is connected and communicates with the proximal end of the moving part 233.

[0093] Furthermore, the outer wall of the guide wire connector 24 is fixedly connected to the inner wall of the mounting groove 2334 by threads, and the distal end of the guide wire connector 24 is sealed to the inner wall of the mounting groove 2334 by a second seal 238. The second seal 238 is provided with a through hole adapted to the puncture guide wire 3. The provision of the second seal 238 can effectively prevent fluid leakage from the second channel 2333.

[0094] In use, the distal end of the puncture guidewire 3 passes sequentially through the guidewire connector 24, the through hole of the second seal 238, the hollow cavity of the moving part 233, and the puncture needle 22, and extends out from the distal end of the puncture needle 22.

[0095] In one embodiment, the puncture needle 22 includes a needle body 221 and a needle tip 222 connected sequentially from its distal end to its proximal end.

[0096] Furthermore, the needle body 221 and the needle tip 222 are connected by bonding or welding, or the needle body 221 and the needle tip 222 are integrally formed.

[0097] Furthermore, the syringe body 221 is made of metal. For example, the metal material can be stainless steel or nickel-titanium alloy.

[0098] Furthermore, the puncture needle 22 also includes a flexible connecting needle tube 223, with the needle tube body 221, the flexible connecting needle tube 223, and the needle tip 222 connected in sequence. The flexible connecting needle tube 223 can be a thiocyanate tube structure or a braided mesh tube structure, so that the flexible connecting needle tube 223 can bend along with the delivery sheath 11.

[0099] In one embodiment, the expander 21 includes an inner layer 211, a middle layer 212 and an outer layer 213 arranged sequentially from the inside to the outside.

[0100] Furthermore, the inner layer 211 and the outer layer 213 are made of the same or different polymer materials, and the polymer materials can be PA and / or PEBAX.

[0101] Furthermore, the intermediate layer 212 is a hyaluronic acid tube structure or a braided mesh structure. The intermediate layer 212 is made of an alloy material, such as stainless steel or nickel-titanium alloy, so that the intermediate layer 212 can play a good supporting role, improve the strength of the expander 21, and thus improve the stability of the system puncture operation.

[0102] In one embodiment, the inner wall of the dilator 21 is provided with a first step 214, and the outer wall of the puncture needle 22 is provided with a second step 224. The first step 214 is located between the second step 224 and the tip 222 of the puncture needle 22. The first step 214 and the second step 224 form a limiting structure. When the spring member 236 is in its natural state, the distance between the first step 214 and the second step 224 is D2, where 0.5mm ≤ D2 ≤ 10mm. This design ensures that the maximum distance the distal end of the puncture needle 22 extends beyond the dilator 21 during the puncture operation is ≤ D2, thereby improving the safety of the puncture operation.

[0103] Ideally, 3mm≤D2≤7mm.

[0104] Furthermore, D2 = D1.

[0105] When the first step 214 and the second step 224 come into contact, the second fluid channel 252 remains open, allowing fluid to flow through.

[0106] In one embodiment, the puncture guidewire 3 includes a mandrel 31 and an insulating tube 32. The proximal end of the mandrel 31 is located outside the insulating tube 32, and the distal end of the mandrel 31 extends along the interior of the insulating tube 32. An electrode puncture head 33 is connected to the distal end of the mandrel 31, and the distal end of the electrode puncture head 33 is located outside the insulating tube 32. The electrode puncture head 33 is arc-shaped, or it can be a circular head or a conical head with an arc transition at its distal end, and the radius of curvature of its distal end is ≥0.3mm.

[0107] Furthermore, a spring coil 33 is fitted onto the mandrel 31, and the spring coil 33 is located inside the insulating tube 32.

[0108] The distal end of the mandrel 31 has a tapered section, the radius of which gradually decreases from its proximal end to its distal end. A spring coil 33 is fitted onto the tapered section of the mandrel 31. The spring coil 33 increases the support force of the distal mandrel and prevents the mandrel from twisting. Simultaneously, the tapered section, through the outer wrapping of the spring coil, becomes a distal guide wire section of uniform diameter. "Uniform diameter" refers to a uniform structure within the allowable engineering range (axial deviation ≤ 1 mm). The pitch of the spring coil is 0.15-0.25 mm, and the length covering the tapered section is ≥ 5 mm. Preferably, it is 5-50 mm, more preferably 5-20 mm.

[0109] In one embodiment, the puncture guidewire 3 is J-shaped or pigtail-shaped.

[0110] In some embodiments, the puncture guidewire 3 is connected to a device for acquiring electrocardiogram (ECG) signals, such as a monitoring electrode. This monitoring electrode may be the same electrode as the radiofrequency puncture electrode or a different electrode. Furthermore, the puncture guidewire can acquire potential information at the contact point. Because the potential information (EGM) at the fossa ovalis differs from that of other tissues in the atrial septum, the location of the fossa ovalis can be accurately determined. The potential difference between the fossa ovalis and other locations in the atrial septum is 0.5-1.5 mV.

[0111] It is understood that, unless otherwise specified or indicated, this application does not impose any particular restrictions on the shape and size of the components of the atrial septal puncture system, and the design can be made according to actual needs.

[0112] The puncture procedure using the system provided in this application includes the following steps:

[0113] First, insert the puncture guidewire 3 along the blood vessel until the electrode puncture head 33 enters the superior vena cava. Then, insert the assembly of the delivery sheath assembly 1 and the dilator assembly 2 along the puncture guidewire 3 into the blood vessel. After adjusting the bend according to the standard puncture procedure, pull it down until the distal end of the dilator 21 reaches the expected puncture tissue in the interatrial septum. Then, extend the puncture guidewire 3 out of the distal end of the dilator 21. After confirming that the electrode puncture head 33 is in contact with the interatrial septum tissue, apply power and push the puncture guidewire 3 forward. After the puncture is completed, push the dilator 2 and the delivery sheath 11 along the puncture guidewire 3. Retain some instruments as needed for subsequent surgery and remove the remaining instruments.

[0114] During the above procedure, if the guidewire 3 cannot complete the septal puncture, the guidewire 3 is withdrawn, and the puncture needle 22 is pushed forward for mechanical puncture. After puncture, contrast agent is injected so that the puncture can be observed and judged through imaging to determine whether the puncture was successful.

[0115] In some embodiments, the distal end of the puncture needle 22 can extend relative to the distal end of the dilator 21. Contrast agent is released to the puncture site before the guidewire discharges, further confirming the specific location of the electrode puncture head and accurately positioning the guidewire. During the guidewire discharge, cold saline is released to lower the temperature of the puncture site and reduce eschar. To further improve safety, the distal tip of the puncture needle 22 is designed with a blunt tip.

[0116] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application and are not intended to limit the scope of protection of this application. Although this application has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of this application without departing from the substance and scope of the technical solutions of this application.

Claims

1. A transseptal puncture system, characterized in that, Includes delivery sheath assembly, dilator assembly, and puncture guidewire. The delivery sheath assembly includes a delivery sheath tube, a bending mechanism, and a delivery handle. The interior of the delivery sheath tube has a central chamber that connects its distal and proximal ends along its axial direction. The dilator assembly includes a dilator, a puncture needle, and a control handle. The dilator is a hollow tubular structure and is inserted into the central cavity of the delivery sheath. The puncture needle is inserted into the dilator, and its proximal end is fixedly connected to the control handle. The control handle includes a moving component and a limiting component. The moving component is fixedly connected to the proximal end of the puncture needle and is used to drive the puncture needle to move axially. The outer wall of the moving component has a limiting step. The control handle includes a dilator fixing component and a handle housing. The dilator fixing component is hollow, and its distal end is fixedly connected to the proximal end of the dilator. The handle housing is hollow and sleeved on the outside of the moving component. The limiting component is located between the moving component and the... Between the dilator fixing components, the limiting component is sleeved on the puncture needle. The inner wall of the limiting component slides with or has a gap with the outer wall of the puncture needle. The moving component is connected to the limiting component by a spring. The proximal end of the limiting component forms a limiting structure with the limiting step. The hollow cavity of the limiting component includes a through groove adapted to the moving component. The distal end of the moving component extends into the through groove. The spring is located in the through groove. The moving component and the limiting component slide with each other through at least one sliding structure. When the spring is in its natural state, the distal end of the puncture needle is located inside the dilator. The axial distance between the proximal end of the limiting component and the limiting step is D1. D1 limits the distance the puncture needle extends out of the dilator to 0.5-10 mm. The handle housing is provided with a limiting hole, which is located between the limiting step and the proximal end of the limiting member; when the spring member is in its natural state, the pin is inserted into the limiting hole, and the inserted end of the pin abuts against the limiting step; The puncture guide wire is inserted into the inner cavity of the puncture needle, and an electrode puncture head is provided at its distal end.

2. The transseptal puncture system as described in claim 1, characterized in that, The bending mechanism includes a bending knob and a pull line. The distal end of the pull line is fixedly connected to the inside of the delivery sheath near its distal end. The proximal end of the pull line is connected to the bending mechanism. The bending mechanism pulls the pull line by rotating the knob clockwise or counterclockwise, so that at least one side of the distal end of the delivery sheath is bent by not less than 90°.

3. The transseptal puncture system as described in claim 2, characterized in that, The bending mechanism includes a limiting sleeve, a transmission block, and a transmission rod. The limiting sleeve is fixedly connected to the bending knob. The limiting sleeve is coaxially disposed at the far end of the conveying handle and rotatably connected to the conveying handle. The transmission block is hollow and sleeved on the transmission rod. The inner wall of the transmission block is fixedly connected to the outer wall of the transmission rod. The transmission rod has a hollow structure and is located inside the conveying handle and sleeved on the conveying sheath. The proximal end of the pull wire is connected to the transmission rod.

4. The atrial septal puncture system as described in claim 3, characterized in that, The transmission rod includes a sliding sleeve and a threaded part connected sequentially from its proximal end to its distal end. The outer wall of the sliding sleeve slides in engagement with the inner wall of the conveying handle. The outer wall of the threaded part is provided with threads, and the threaded part is threaded in engagement with the transmission block.

5. The atrial septal puncture system as described in claim 1, characterized in that, The distal end of the limiting member is sealed to the dilator fixing member by a first sealing member, which has a through hole adapted to the puncture needle.

6. The transseptal puncture system as described in claim 1, characterized in that, The handle housing has a slot, and the outer wall of the moving part has a pushing part. One end of the pushing part passes through the slot and protrudes outside the handle housing. The outer wall of the pushing part slides in conjunction with the inner wall of the slot.

7. The atrial septal puncture system as described in claim 6, characterized in that, The moving part is provided with a fluid channel communicating with the inner cavity of the puncture needle, and the fluid channel extends to the pushing part and is connected to a second three-way valve through a conduit.

8. The system as described in claim 1, characterized in that, The inner cavity of the puncture needle forms a first fluid channel, and the outer wall of the puncture needle and the inner wall of the dilator form a second fluid channel. The outer wall of the puncture needle is provided with a connecting hole, and the first fluid channel and the second fluid channel are connected through the connecting hole. The puncture needle moves axially under the drive of the control handle, causing the connecting hole and the distal port of the first fluid channel to move synchronously.

9. The transseptal puncture system as described in claim 1, characterized in that, The expander assembly also includes a guide wire connector, which has a hollow structure and is connected and communicates with the proximal end of the moving part; The guide wire connector and the proximal end of the moving part are sealed together by a second seal, the second seal having a through hole adapted to the puncture guide wire.

10. The transseptal puncture system as described in claim 1, characterized in that, The puncture needle includes a needle tip, a flexible connecting needle tube, and a needle tube body connected sequentially from its distal end to its proximal end.

11. The transseptal puncture system as described in claim 1, characterized in that, The inner wall of the dilator is provided with a first step, and the outer wall of the puncture needle is provided with a second step. The first step is located between the second step and the tip of the puncture needle, and the first step and the second step form a limiting structure.

12. The transseptal puncture system as described in claim 1, characterized in that, The puncture guidewire includes a mandrel and an insulating tube. The distal end of the mandrel is connected to an electrode puncture head. The distal end of the mandrel has a tapered section. A spring coil is sleeved on the outside of the tapered section. The spring coil covers the tapered section and forms a distal guidewire segment of equal diameter.

13. The transseptal puncture system as described in claim 1, characterized in that, The puncture guidewire includes a monitoring electrode for detecting potential information at the location of the fossa ovalis.

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