A lancing device

The puncture device driven by the ejection mechanism, combined with the design of the trigger and the shape memory alloy skeleton, solves the problems of inaccuracy and low efficiency caused by the differences in the atrial septum of patients in traditional puncture methods, and realizes efficient and safe puncture operation.

CN122140333APending Publication Date: 2026-06-05VICKOR QIYUAN (WUXI) MEDICAL TECHNOLOGY CO LTD +1

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
VICKOR QIYUAN (WUXI) MEDICAL TECHNOLOGY CO LTD
Filing Date
2025-12-31
Publication Date
2026-06-05

AI Technical Summary

Technical Problem

Traditional puncture methods cannot be precisely controlled due to the varying atrial septal conditions of each patient, resulting in inaccurate and inefficient punctures and a risk of tissue damage.

Method used

A puncture device is employed, which utilizes the potential energy released by the ejection mechanism to propel the puncture piece forward rapidly. Combined with the precise triggering of the trigger element, efficient control of the puncture action is achieved. The puncture depth is adjusted by regulating the stroke of the ejection mechanism. A shape memory alloy skeleton and an outer sheath are used to ensure the safety and accuracy of the puncture.

Benefits of technology

It achieves precision and efficiency in puncture, reduces the risk of tissue damage, adapts to the needs of atrial septal puncture in different clinical scenarios, and improves the safety and efficiency of puncture surgery.

✦ Generated by Eureka AI based on patent content.

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Abstract

The application discloses a puncture device. The puncture device comprises a puncture member, an operating handle, a shooting mechanism and a trigger member, the shooting mechanism is movably arranged on the handle shell, the puncture member is fixedly connected to the shooting mechanism and penetrates the handle shell, and the trigger member is movably arranged on the handle shell. When an external force is applied to the trigger member, the shooting mechanism can release potential energy and drive the puncture member to quickly advance, thereby completing the puncture action. In the above manner, the puncture device can more accurately control the puncture strength and speed, avoids excessive puncture and reduces the risk of tissue damage, and greatly improves the safety, accuracy and efficiency of the puncture operation.
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Description

Technical Field

[0001] This application relates to the field of puncture device technology, and in particular to a puncture device. Background Technology

[0002] The atrial septum is located between the left and right atria and consists of two layers of endocardium, a small amount of myocardium, and connective tissue. The muscular portion, excluding the fossa ovalis, is 3-4 mm thick. The fossa ovalis is the thinnest part, only about 1 mm thick in the central area, making it an ideal location for transseptal puncture (TSP). The position of the fossa ovalis in the heart varies greatly among individuals. In patients with transverse heart, the fossa ovalis is lower than normal, while in patients with vertical heart, it is higher. In patients with a higher left atrium and a lower right atrium, the fossa ovalis area is very small. The position of the fossa ovalis also differs from the norm in patients with atrial septal aneurysm, giant aortic sinus, persistent left superior vena cava, congenital heart disease, dextrocardia, and straight back syndrome.

[0003] Atrial septal puncture is one of the most common interventional cardiology techniques. It originated in 1958, initially used for left ventricular catheterization and left ventricular pressure measurement. It was popularized after the 1980s and became a routine technique with the development of percutaneous mitral valve treatment and atrial fibrillation catheter ablation. It rapidly gained popularity in the 21st century. Atrial septal puncture is mainly used for the treatment of left ventricular arrhythmias, left atrial appendage closure, percutaneous left ventricular assist device implantation, and various mitral valve surgeries.

[0004] In some patients with thickened atrial septum, fibrosis, or scarring (such as post-operatively), traditional mechanical puncture requires a large thrust, which can easily lead to complications such as perforation of the posterior wall of the left atrium and cardiac tamponade. While radiofrequency puncture can reduce puncture resistance, it requires precise control of energy output to avoid excessive tissue damage or the risk of embolism.

[0005] In recent years, with the rapid development of catheter ablation therapy for atrial fibrillation, the requirements for TSP technology have reached a new level, requiring operators to be able to efficiently and accurately puncture through the interatrial septum while avoiding damage to the atria and pericardium. Summary of the Invention

[0006] This application provides a puncture device to solve the problem that traditional puncture methods are not accurate and efficient because the puncture process cannot be precisely controlled due to the different room septum conditions of each patient.

[0007] To solve the above-mentioned technical problems, this application adopts the following technical solution: providing a puncture device. The puncture device includes: a puncture element; an operating handle, including a handle housing, a ejection mechanism, and a trigger element. The ejection mechanism is movably disposed on the handle housing, the puncture element is fixedly connected to the ejection mechanism and passes through the handle housing, and the trigger element is movably disposed on the handle housing. When an external force is applied to the trigger element, the ejection mechanism releases potential energy and propels the puncture element forward rapidly, completing the puncture action.

[0008] In some embodiments, the ejection mechanism includes an ejector and an elastic element. The ejector is movably disposed on the handle housing and forms a stop with the handle housing. The elastic element is elastically compressed between the ejector and the tail end of the handle housing. The piercing element is fixedly connected to the ejector and passes through the ejector. The elastic element is also sleeved on the piercing element. When the trigger is activated, the ejector releases its stop limit and, under the push of the elastic element, drives the piercing element forward rapidly.

[0009] In some embodiments, the inner wall of the handle housing is provided with a stop portion; The ejector includes an ejector body and an elastic cantilever connected to the outside of the ejector body. The ejector body is slidably engaged with the handle housing. The piercing member is fixedly connected to the ejector body. The end of the elastic cantilever forms a stop engagement with the blocking part. The trigger is used to release the stop between the elastic cantilever and the blocking part, so that the ejector body can drive the piercing part forward rapidly under the push of the elastic element.

[0010] In some embodiments, the handle housing is provided with a groove, and the ejector further includes a handle portion disposed on the ejector body. The handle portion slides with the groove and extends through the groove to the outside of the handle housing, so that the ejector mechanism can be reset by pulling the handle portion, so that the end of the elastic cantilever re-forms a stop engagement with the stop portion.

[0011] In some embodiments, the length of the chute is adjustable; The puncture depth of the puncture member can be adjusted by controlling the travel distance of the ejection mechanism through the adjustment of the length of the slide groove.

[0012] In some embodiments, the trigger includes a button and a spring, the button being movably disposed on the handle housing, and the spring being disposed between the button and the handle housing and providing a return force; When the button is pressed, the tail end of the button acts on the elastic cantilever, causing the elastic cantilever to disengage from the blocking part, thereby releasing the ejection mechanism.

[0013] In some embodiments, the puncture device further includes an outer sheath connected to the handle housing, and the puncture element is further inserted through the outer sheath; Before the ejection mechanism is released, the distal end of the puncture member is not exposed at the distal end of the outer sheath; after the ejection mechanism is released, the puncture member moves forward under the action of the ejection mechanism, so that the distal end of the puncture member extends out of the distal end of the outer sheath to complete the puncture action.

[0014] In some embodiments, a shape memory alloy skeleton is provided in the distal end of the outer sheath, so that the distal end of the outer sheath is conical at room temperature to constrain the distal end of the puncture member to be located inside the outer sheath; when the shape memory alloy skeleton reaches the phase transition temperature, the distal end of the outer sheath automatically opens to allow the distal end of the puncture member to extend and complete the puncture.

[0015] In some embodiments, the operating handle further includes a flushing component mounted on the handle housing. The flushing component includes a sleeve and a flushing tube connected together. The proximal end of the outer sheath is connected to one end of the sleeve. The flushing tube communicates with the sleeve, and the flushing port of the flushing tube is located outside the handle housing. The other end of the cannula is provided with a sealing element and a sealing cap. The puncture element passes through the cannula, the sealing element and the sealing cap and extends to the ejection mechanism. The sealing cap presses and fixes the sealing element to the other end of the cannula to form a dynamic seal between the puncture element and the cannula.

[0016] In some embodiments, the puncture member includes a puncture end, a flexible segment, and a rigid segment connected in sequence, the puncture end being used to perform puncture, the flexible segment being used to provide flexibility, the rigid segment being connected to the ejection mechanism to transmit thrust, and the rigid segment passing through the sleeve, the seal, and the sealing cap.

[0017] The beneficial effects of this application are as follows: The puncture device disclosed in this application releases potential energy through an ejection mechanism to drive the puncture piece forward rapidly, thereby enabling precise control of puncture force and speed, avoiding over-puncture and reducing the risk of tissue damage. This effectively solves the problems of inaccuracy and low efficiency caused by differences in the atrial septum condition of patients in traditional puncture methods. The trigger element enables precise triggering of the puncture action, making the puncture operation more efficient and convenient. Therefore, the puncture device provided by this application can be adapted to the atrial septum puncture needs in different clinical scenarios, greatly improving the safety, accuracy and efficiency of puncture surgery. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort, wherein: Figure 1 This is a schematic diagram of the structure of an embodiment of the puncture device provided in this application; Figure 2 Is it like this? Figure 1 A partial structural diagram of the puncture device shown; Figure 3 Is it like this? Figure 1 A schematic diagram showing the state of the puncture device and the interatrial septum tissue before puncture. Figure 4 Is it like this? Figure 1 The diagram shows the state of the puncture device and the interatrial septum tissue after puncture. Detailed Implementation

[0019] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0020] The terms "first," "second," and "third" used in the embodiments of this application are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first," "second," or "third" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or device that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, products, or devices.

[0021] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a mutually exclusive, independent, or alternative embodiment. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0022] This application provides a puncture device 100, see reference. Figures 1 to 4 , Figure 1 This is a schematic diagram of an embodiment of the puncture device provided in this application. Figure 2 Is it like this? Figure 1 A partial structural diagram of the puncture device shown. Figure 3 Is it like this? Figure 1 The diagram shows the state of the puncture device and the interatrial septum tissue before puncture. Figure 4 Is it like this? Figure 1 The diagram shows the state of the puncture device and the interatrial septum tissue after puncture.

[0023] The puncture device 100 includes a puncture element 10, an outer sheath 20, and an operating handle 30. The puncture element 10 is slidably fitted in the outer sheath 20, and the outer sheath 20 is connected to the operating handle 30. The operating handle 30 can control the movement of the puncture element 10 along the outer sheath 20, thereby achieving precise control of the puncture action of the interatrial septum tissue.

[0024] In this embodiment, the operating handle 30 includes a handle housing 31, an ejection mechanism 32, and a trigger 33. The ejection mechanism 32 is movably disposed on the handle housing 31. The piercing member 10 is fixedly connected to the ejection mechanism 32 and passes through the handle housing 31. The trigger 33 is movably disposed on the handle housing 31. When an external force is applied to the trigger 33, the ejection mechanism 32 can release potential energy and drive the piercing member 31 to move forward rapidly, thereby completing the piercing action.

[0025] The stroke of the ejection mechanism 32 determines the puncture depth of the puncture piece 10. By adjusting or setting the stroke of the ejection mechanism 32, the puncture depth of the puncture piece 10 can be precisely controlled to meet the puncture needs of different patients with different atrial septal conditions.

[0026] Driven by the ejection mechanism 32, the puncture device 10 advances rapidly along the outer sheath 20. Its distal end (puncture end) can quickly penetrate the target tissue to complete the puncture action. Because the stroke of the ejection mechanism 32 is fixed, the puncture depth is controllable and consistent, effectively avoiding the problem of excessive or insufficient puncture depth caused by uneven manual operation force. Excessive puncture will lead to a great risk of tissue damage, thus improving the safety and repeatability of the operation.

[0027] Once the puncture location is determined and the distal end of the outer sheath 20 is placed against the puncture location of the target tissue, the user can apply external force to the trigger 33 to cause the ejection mechanism 32 to release potential energy, which will drive the puncture member 10 to move forward rapidly along the outer sheath 20. Its distal end (puncture end) can quickly penetrate the interatrial septum tissue, achieving a precise and stable puncture operation.

[0028] The distal end of the puncture component 10 is designed with a sharp bevel structure to reduce puncture resistance and improve penetration efficiency. It is made of high-hardness stainless steel or nickel-titanium alloy to ensure that it maintains rigidity and elasticity during rapid advancement.

[0029] In this embodiment, the puncture device 100 releases potential energy through the ejection mechanism 32 to drive the puncture piece 10 forward rapidly, thereby enabling precise control of the puncture force and speed. Furthermore, the stroke of the ejection mechanism 32 is fixed, avoiding over-puncture and reducing the risk of tissue damage. This effectively solves the problems of inaccuracy and low efficiency caused by differences in the atrial septum conditions of patients in traditional puncture methods. The trigger element 33 enables precise triggering of the puncture action, making the puncture operation more efficient and convenient. Therefore, the puncture device 100 provided in this application can be adapted to the atrial septum puncture needs in different clinical scenarios, greatly improving the safety, accuracy, and efficiency of puncture surgery.

[0030] Specifically, the ejection mechanism 32 includes an ejector 322 and an elastic element 324. The ejector 322 is movably disposed on the handle housing 31 and forms a stop with the handle housing 31. The elastic element 324 is elastically compressed and disposed between the ejector 322 and the tail end of the handle housing 31. The piercing element 10 is fixedly connected to the ejector 322 and passes through the ejector 322. The elastic element 324 is also sleeved on the piercing element 10. When the trigger 33 is triggered, the ejector 322 releases the stop limit and drives the piercing element 10 forward rapidly under the push of the elastic element 324.

[0031] The elastic element 324 is a spring or elastic sleeve, etc. When the ejector 322 and the handle housing 31 form a stop engagement, the elastic element 324 is in a compressed state, and its stored potential energy is locked. When an external force is applied to the trigger 33, the stop restriction of the ejector mechanism 32 is released, and the elastic element 324 quickly releases the stored potential energy, pushing the ejector 322 to move forward quickly along the handle housing 31, thereby driving the piercing element 10 to move forward quickly and complete the piercing action. The trigger 33 achieves trigger control by releasing the stop restriction of the ejector 322. Its structural configuration allows the operator to operate accurately with one hand, improving piercing efficiency and safety.

[0032] The ejector 322 and the handle housing 31 form a releasable stop engagement to ensure stable locking before potential energy release, while allowing instantaneous unlocking after triggering, thus achieving rapid response and precise control of the piercing action.

[0033] The ejector 322 and the handle housing 31 are also configured to slide together to ensure smooth and unbiased movement during ejection, ensuring that the distal end of the puncture member 10 advances in a straight line along the predetermined trajectory, effectively avoiding tissue damage caused by shaking or deviation.

[0034] Specifically, the inner wall of the handle housing 31 is provided with a stop portion 310; the ejector 322 includes an ejector body 321 and an elastic cantilever 323 connected to the outside of the ejector body 321. The ejector body 321 is slidably engaged with the handle housing 31. The piercing member 10 is fixedly connected to the ejector body 321. The end of the elastic cantilever 323 forms a stop engagement with the stop portion 310. The trigger member 33 is used to release the stop engagement between the elastic cantilever 323 and the stop portion 310, so that the ejector body 321 drives the piercing member 10 to advance rapidly under the push of the elastic member 324.

[0035] The piercing element 10 and the ejector body 321 can be securely connected by interference fit, or by threaded connection or bonding, to ensure that the piercing element 10 can move synchronously with the ejector body 321 without loosening.

[0036] The elastic cantilever 323 is in an open position relative to the ejection body 321. In its free state, the end of the elastic cantilever 323 can maintain a stop engagement with the blocking part 310, thereby preventing the ejection body 321 from moving forward. When the trigger 33 is activated, it pushes the end of the elastic cantilever 323 away from the blocking part 310, thereby releasing the stop restriction. The elastic element 324 then releases energy, driving the ejection element 322 and the piercing element 10 to rush forward rapidly and complete the precise piercing.

[0037] Furthermore, in this embodiment, the ejector 322 can also be reset, so that the end of the elastic cantilever 323 re-engages with the stop portion 310 to form a stop, and the elastic element 324 is once again in a compressed state, enabling the device to be reused. This reset process does not require disassembly of components, is simple to operate, and facilitates rapid clinical preparation. At the same time, the elastic recovery performance of the elastic cantilever 323 ensures that it can maintain a stable locking effect after multiple triggers, improving the reliability and service life of the puncture-proof device 100.

[0038] Specifically, the handle housing 31 is provided with a slide groove 312, and the ejector 322 also includes a handle portion 325 provided on the ejector body 321. The handle portion 325 is slidably engaged with the slide groove 312 and extends to the outside of the handle housing 31 through the slide groove 312, so that the ejector mechanism 32 can be reset by pulling the handle portion 325, so that the end of the elastic cantilever 323 re-forms a stop engagement with the stop portion 310.

[0039] In this embodiment, the handle housing 31 is provided with multiple sliding grooves 312, and the ejector body 321 is provided with multiple handle portions 325. Each handle portion 325 is respectively embedded in the corresponding sliding groove 312 and can slide along it, making it convenient for the operator to apply force through the exposed handle portion to move the ejector body 321 backward to the initial locking position. The cooperation structure between the sliding groove 312 and the handle portion 325 restricts the movement trajectory of the ejector body 321, ensuring that the ejector 322 moves smoothly and without deviation during puncture and reset, while also making it easy to observe whether the reset is in place; when the end of the elastic cantilever 323 stops again at the stop portion 310, the reset and locking are completed, and the puncture device 100 returns to the ready-to-fire state.

[0040] Furthermore, the length of the slide 312 is adjustable; by adjusting the length of the slide 312, the travel distance of the ejection mechanism 32 can be controlled, thereby adjusting the puncture depth of the puncture member 10.

[0041] Optionally, the handle housing 31 is provided with replaceable slide parts, and different slide parts are provided with slides 312 of different lengths to adapt to different puncture depth requirements. That is, the stroke of the ejection mechanism 32 can be adjusted by replacing the slide parts, thereby improving the versatility of the puncture device 100.

[0042] Optionally, the length of the groove 312 can also be adjusted via a telescopic structure to further improve adjustment accuracy and operational flexibility, meeting the puncture needs of multiple scenarios.

[0043] Optionally, the handle housing 31 is provided with multiple sets of slide grooves 312 of different lengths. Each set of slide grooves 312 is arranged around the handle housing 31. The operator can rotate to select the corresponding slide groove set according to the required puncture depth to realize the stroke adjustment of the ejection mechanism 32. This method has a compact structure and convenient stroke switching.

[0044] In this embodiment, the trigger 33 includes a button 332 and a spring 334. The button 332 is movably disposed on the handle housing 31, and the spring 334 is disposed between the button 332 and the handle housing 31 and provides a reset elastic force. When the button 332 is pressed, the tail end of the button 332 acts on the elastic cantilever 323, causing the elastic cantilever 323 to disengage from the blocking part 310, thereby releasing the ejection mechanism 32. When the button 332 is released, the button 332 resets under the action of the spring 334, in preparation for the next trigger operation.

[0045] Furthermore, the trigger 33 also includes a cap (not shown) hinged to the handle housing 31, which covers the button 332 to prevent the operator from accidentally triggering the button 332. When it is necessary to trigger the button 332, the cap must be lifted first, and then the button 332 must be pressed to ensure the safety and reliability of the puncture operation during the procedure.

[0046] The cap effectively prevents accidental misoperation caused by accidental contact, further improving the safety and controllability of the puncture device 100 in clinical use.

[0047] In this embodiment, the puncture device 100 further includes an outer sheath 20 connected to the handle housing 31, and the puncture member 10 is also inserted into the outer sheath 20; wherein, before the ejection mechanism 32 is released, the distal end of the puncture member 10 is not exposed at the distal end of the outer sheath 20; after the ejection mechanism 32 is released, the puncture member 10 moves forward under the drive of the ejection mechanism 32, so that the distal end of the puncture member 10 extends out of the distal end of the outer sheath 20 to complete the puncture action.

[0048] In other words, before the puncture is completed, the distal end of the puncture piece 10 is concealed within the outer sheath 20, effectively avoiding the safety risks associated with accidental exposure of the puncture tip. When the ejection mechanism 32 is triggered, the puncture piece 10 quickly extends forward to complete the precise puncture. This design not only ensures safety before the procedure but also guarantees the speed and stability of the puncture action, making it particularly suitable for clinical scenarios requiring high-precision puncture control. Simultaneously, the outer sheath 20 guides and supports the puncture path, further enhancing the consistency and reliability of the puncture.

[0049] In this embodiment, a shape memory alloy skeleton (not shown) is provided inside the distal end of the outer sheath tube 20, so that the distal end of the outer sheath tube 20 is conical at room temperature to constrain the distal end of the puncture member 10 to be located inside the outer sheath tube 20; when the shape memory alloy skeleton reaches the phase transition temperature, the distal end of the outer sheath tube 20 automatically opens to allow the distal end of the puncture member 10 to extend and complete the puncture.

[0050] The distal end of the outer sheath 20 is cone-shaped at room temperature, which facilitates the smooth insertion of the outer sheath 20 into the tissue. When the temperature of the distal end of the outer sheath 20 rises to the phase transition temperature, the shape memory alloy skeleton inside it expands on its own, forming an umbrella-shaped expansion structure, which allows the puncture element 10 hidden inside to extend smoothly and complete the puncture action.

[0051] The phase transition temperature can be set at or slightly above the human body temperature to ensure that the morphological change is automatically triggered after the outer sheath 20 enters the body without any additional operation.

[0052] In this embodiment, the operating handle 31 also includes a flushing component 34, which is installed on the handle housing 31. The flushing component 34 includes a sleeve 342 and a flushing tube 344 connected together. The proximal end of the outer sheath 20 is connected to one end of the sleeve 342. The flushing tube 344 is connected to the sleeve 342 and the flushing port of the flushing tube 344 is located outside the handle housing 31. The flushing fluid can be injected through the port of the flushing tube 344 and flow into the outer sheath 20 through the sleeve 342 until it reaches the distal end of the outer sheath 20.

[0053] The other end of the cannula 342 is provided with a seal 345 and a sealing cap 346. The puncture member 10 passes through the cannula 342, the seal 345 and the sealing cap 346 and extends to the ejection mechanism 32. The sealing cap 346 presses the seal 345 to the other end of the cannula 342 to form a dynamic seal between the puncture member 10 and the cannula 342 to prevent the flushing fluid from leaking.

[0054] In this embodiment, the puncture member 10 includes a puncture end 101, a flexible section 102 and a rigid section 103 connected in sequence. The puncture end 101 is used to perform puncture, the flexible section 102 is used to provide flexibility, and the rigid section 103 is connected to the ejection mechanism 32 to transmit thrust. The rigid section 103 passes through the sleeve 342, the seal 345 and the sealing cap 346 and the ejection member 322.

[0055] The puncture end 101 (the distal end of the puncture member 10) has a sharp cutting edge to achieve precise puncture, the flexible section 102 gives the puncture member 102 an overall bendable characteristic, so that it can conform to the direction of the outer sheath tube 20 when passing through a curved path; the rigid section 103 ensures that sufficient pushing force and stability are maintained during the puncture operation.

[0056] Alternatively, the puncture element 10 may be a solid rod-shaped structure, such as a puncture needle.

[0057] In this embodiment, the puncture element 10 is a puncture tube used to deliver irrigation fluid, guidewires, or other interventional instruments. The inner lumen of the puncture tube can also serve as a delivery channel, allowing for the direct injection of contrast agents or saline after puncture, or the introduction of guidewires for subsequent interventional procedures, thereby improving surgical efficiency and safety.

[0058] Traditional puncture devices require the needle to be withdrawn after puncture, followed by the separate introduction of a guidewire or irrigation device, which is cumbersome and prone to path deviation. This embodiment, through integrated design, allows for direct injection of irrigation fluid or placement of a guidewire via the puncture tube while maintaining the internal lumen channel in the puncture element 10, eliminating the need to change instruments and achieving zero-exchange operation, significantly simplifying the TSP procedure.

[0059] The puncture end 101 is a puncture needle tube, the flexible section 102 is a flexible tube, and the rigid section 103 is a rigid tube. The puncture needle tube is located at the distal end of the puncture tube 10 for puncture. The flexible tube is used to provide flexibility, and the rigid tube is connected to the ejection mechanism 32 to transmit the thrust provided by the ejection mechanism 32.

[0060] Furthermore, the puncture tube also includes a Luer flushing tube 104 connected to a rigid tube, at least a portion of which protrudes outside the handle housing 31. The Luer flushing tube 104 is used to connect to a flushing device or to allow a guide wire to be inserted into the puncture tube.

[0061] The puncture needle can be made of stainless steel tube cut into a beveled tip and inlaid with a platinum-tungsten / tantalum contrast ring to facilitate intraoperative detection and accurately identify its tip position; the flexible tube is formed by stainless steel braiding process, and the proximal end of the puncture needle is connected to the flexible tube by laser welding; the distal end of the flexible tube is connected to the rigid tube by laser welding; the proximal end of the rigid tube is bonded to the Luer irrigation tube with high-strength epoxy resin or connected by threads.

[0062] The puncture device disclosed in this application releases potential energy through an ejection mechanism to propel the puncture piece forward rapidly, thereby enabling precise control of puncture force and speed, avoiding over-puncture and reducing the risk of tissue damage. It effectively solves the problems of inaccuracy and low efficiency caused by differences in the atrial septum condition of patients in traditional puncture methods. The trigger element enables precise triggering of the puncture action, making the puncture operation more efficient and convenient. Therefore, the puncture device provided in this application can be adapted to the atrial septum puncture needs in different clinical scenarios, greatly improving the safety, accuracy and efficiency of puncture surgery.

[0063] The above descriptions are merely embodiments of this application and do not limit the patent scope of this application. Any equivalent structural or procedural transformations made based on the description and drawings of this application, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of this application. The technical solutions in the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of this application without creative effort are within the protection scope of this application.

Claims

1. A puncture device, characterized in that, The puncture device includes: Puncture piece; An operating handle includes a handle housing, a ejection mechanism, and a trigger. The ejection mechanism is movably disposed on the handle housing. The piercing element is fixedly connected to the ejection mechanism and passes through the handle housing. The trigger is movably disposed on the handle housing. When an external force is applied to the trigger, the ejection mechanism can release potential energy and drive the piercing member forward rapidly to complete the piercing action.

2. The puncture device according to claim 1, characterized in that, The ejection mechanism includes an ejector and an elastic element. The ejector is movably disposed on the handle housing and forms a stop with the handle housing. The elastic element is elastically compressed between the ejector and the tail end of the handle housing. The piercing element is fixedly connected to the ejector and passes through the ejector. The elastic element is also sleeved on the piercing element. When the trigger is activated, the ejector releases its stop limit and, under the push of the elastic element, drives the piercing element forward rapidly.

3. The puncture device according to claim 2, characterized in that, The inner wall of the handle housing is provided with a stop; The ejector includes an ejector body and an elastic cantilever connected to the outside of the ejector body. The ejector body is slidably engaged with the handle housing. The piercing member is fixedly connected to the ejector body. The end of the elastic cantilever forms a stop engagement with the blocking part. The trigger is used to release the stop between the elastic cantilever and the blocking part, so that the ejector body can drive the piercing part forward rapidly under the push of the elastic element.

4. The puncture device according to claim 3, characterized in that, The handle housing is provided with a sliding groove, and the ejector also includes a handle portion disposed on the ejector body. The handle portion slides in cooperation with the sliding groove and extends to the outside of the handle housing through the sliding groove, so that the ejector mechanism can be reset by pulling the handle portion, so that the end of the elastic cantilever re-forms a stop engagement with the stop portion.

5. The puncture device according to claim 4, characterized in that, The length of the chute is adjustable; The puncture depth of the puncture member can be adjusted by controlling the travel distance of the ejection mechanism through the adjustment of the length of the slide groove.

6. The puncture device according to claim 3, characterized in that, The trigger includes a button and a spring. The button is movably disposed on the handle housing, and the spring is disposed between the button and the handle housing and provides a return force. When the button is pressed, the tail end of the button acts on the elastic cantilever, causing the elastic cantilever to disengage from the blocking part, thereby releasing the ejection mechanism.

7. The puncture device according to claim 1, characterized in that, The puncture device further includes an outer sheath connected to the handle housing, and the puncture element is also inserted through the outer sheath; Before the ejection mechanism is released, the distal end of the puncture member is not exposed at the distal end of the outer sheath; after the ejection mechanism is released, the puncture member moves forward under the action of the ejection mechanism, so that the distal end of the puncture member extends out of the distal end of the outer sheath to complete the puncture action.

8. The puncture device according to claim 7, characterized in that, The distal end of the outer sheath is provided with a shape memory alloy skeleton, which makes the distal end of the outer sheath conical at room temperature to constrain the distal end of the puncture member to be located inside the outer sheath; when the shape memory alloy skeleton reaches the phase transition temperature, the distal end of the outer sheath automatically opens to allow the distal end of the puncture member to extend and complete the puncture.

9. The puncture device according to claim 7, characterized in that, The operating handle also includes a flushing component, which is mounted on the handle housing. The flushing component includes a sleeve and a flushing tube connected together. The proximal end of the outer sheath is connected to one end of the sleeve. The flushing tube communicates with the sleeve, and the flushing port of the flushing tube is located outside the handle housing. The other end of the cannula is provided with a sealing element and a sealing cap. The puncture element passes through the cannula, the sealing element and the sealing cap and extends to the ejection mechanism. The sealing cap presses and fixes the sealing element to the other end of the cannula to form a dynamic seal between the puncture element and the cannula.

10. The puncture device according to claim 9, characterized in that, The puncture member includes a puncture end, a flexible section, and a rigid section connected in sequence. The puncture end is used to perform puncture, the flexible section is used to provide flexibility, and the rigid section is connected to the ejection mechanism to transmit thrust. The rigid section passes through the sleeve, the seal, and the sealing cap.