A coaxial double-layer cannula controllable skin-penetrating puncture needle for vascular intervention.

Abstract

This invention provides a coaxial double-layer cannula controllable skin-piercing puncture needle for vascular intervention, comprising a handle, an inner puncture needle tube, and an outer incision cannula body. The proximal end of the inner puncture needle tube is connected to the handle, and the distal end of the inner puncture needle tube is a puncture tip. The outer incision cannula body is sleeved outside the inner puncture needle tube and can slide along the axial direction of the inner puncture needle tube. The distal end of the outer incision cannula body is provided with a cutting edge. At least one protective protrusion is provided on the outer wall of the distal end of the inner puncture needle tube. The maximum radial dimension of the protective protrusion is larger than the inner diameter of the outer incision cannula body, which is used to axially block the outer incision cannula body to prevent the cutting edge of the outer incision cannula body from contacting the blood vessel wall.

Description

Technical Field

[0001] This invention relates to the field of puncture needle technology, and in particular to a coaxial double-layer cannula controllable skin-piercing puncture needle for vascular intervention. Background Technology

[0002] Currently, the modified Seldinger technique is commonly used in clinical practice to establish access for vascular interventional procedures. This technique requires the use of multiple independent instruments, including puncture needles, scalpels, and vascular sheaths, in several steps. Taking a typical femoral artery interventional procedure as an example, the standard operating procedure is usually as follows: First, the doctor uses a needle to percutaneously puncture the femoral artery. Once high-pressure arterial blood is observed flowing smoothly from the needle tip, confirming the needle has entered the vessel lumen, the needle is held in place, and a guidewire is advanced into the vessel. Under imaging guidance, after confirming the guidewire is correctly positioned along the vessel path, the needle is withdrawn along the guidewire. At this point, only the guidewire remains at the skin puncture site. Next, the doctor uses a separate scalpel to make a longitudinal incision along the guidewire at the skin puncture site and subcutaneous tissue to widen the subcutaneous access. Finally, a vascular sheath is advanced and inserted along the guidewire, thus completing the establishment of the percutaneous vascular access.

[0003] To integrate instruments and simplify procedures, some integrated devices combining puncture and skin incision functions have emerged in the prior art. For example, Chinese patent CN218589093U discloses a puncture and skin dilation needle. The basic structure of this type of device is typically as follows: an outer puncture needle tube is coaxially sleeved outside an inner puncture needle tube, and the two are detachably connected at their proximal ends by threads, snaps, or rubber parts. The inner puncture needle tube has a smooth wall, while the distal end of the outer puncture needle tube has a cutting edge for incision.

[0004] However, the inner puncture needle has a smooth wall and lacks any physical obstruction. After a successful puncture, when the operator pushes the outer puncture needle forward to cut through the skin and subcutaneous tissue, the depth of advancement depends entirely on the operator's feel and experience, without any rigid resistance. In deep vessel punctures such as the femoral artery, the vessel is covered by a dense fascia layer, resulting in complex variations in tissue resistance. If the operator applies slightly too much force, or if the patient's subcutaneous tissue is thin, the sharp edge of the outer puncture needle can easily advance excessively in an uncontrolled state, thereby cutting through the vessel wall. This iatrogenic injury can lead to serious complications, such as a large hematoma at the puncture site, a pseudoaneurysm, or even a life-threatening retroperitoneal hematoma. Summary of the Invention

[0005] The purpose of this invention is to address the shortcomings of the prior art by providing a coaxial double-layer cannula controllable skin-piercing puncture needle for vascular intervention. This needle has at least one protective protrusion on the outer wall of the distal end of the inner puncture needle tube to prevent the cutting edge on the outer incision tube from accidentally damaging the blood vessel wall.

[0006] To achieve the above objectives, the present invention provides the following technical solution: A coaxial double-layer cannula controllable skin-penetrating puncture needle for vascular intervention includes: handle; An internal puncture needle, the proximal end of which is connected to the handle, and the distal end of which is a tip for puncture. An external incision tube body is sleeved outside the internal puncture needle tube and can slide along the axial direction of the internal puncture needle tube. The distal end of the external incision tube body is provided with a cutting blade. At least one protective protrusion is provided on the outer wall of the distal end of the internal puncture needle. The maximum radial dimension of the protective protrusion is greater than the inner diameter of the external incision tube body. It is used to block the external incision tube body in the axial direction to prevent the cutting edge of the external incision tube body from contacting the blood vessel wall.

[0007] In a preferred embodiment, the number of protective protrusions is two, and they are arranged circumferentially along the inner puncture needle tube.

[0008] In a preferred embodiment, the protective protrusion has a frontal side facing the distal end of the internal puncture needle and a rearal side facing the proximal end of the internal puncture needle. Wherein, the front side of the protective protrusion forms a first angle a with the axial direction of the internal puncture needle tube, and the rear side of the protective protrusion forms a second angle b with the axial direction of the internal puncture needle tube. The first included angle a is smaller than the second included angle b.

[0009] In a preferred embodiment, a locking mechanism is also included, which, when in a locked state, locks the handle and the externally cut tube body to prevent relative movement between them.

[0010] In a preferred embodiment, the locking mechanism includes a locking part that cooperates with the handle and the outer cut tube body, and a separable locking member. When the locking member engages with the cooperating locking part, the locking mechanism is in the locked state.

[0011] In a preferred embodiment, the locking part that cooperates with each other is a through hole respectively provided on the handle and the outer cut tube body, and the locking member is a pin that can be inserted into the through hole.

[0012] In a preferred embodiment, the locking element is connected to the handle via an anti-loss rope.

[0013] In a preferred embodiment, the cutting edge is a double-sided wedge-shaped edge.

[0014] In a preferred embodiment, the proximal end of the externally cut tube body is provided with a finger pusher for finger pushing.

[0015] Compared with existing technologies, this technical solution has the following advantages: By placing a protective protrusion at the distal end of the internal puncture needle, and ensuring its maximum outer diameter is larger than the inner diameter of the external incision cannula, the cutting edge of the external incision cannula is restricted by the protective protrusion and cannot contact the vessel wall. This provides a revolutionary safety guarantee for high-risk interventional procedures on large blood vessels (such as the femoral artery).

[0016] During puncture, a locking mechanism secures the external incision cannula and the internal puncture needle together. During skin dilation, the pin is removed, allowing the external incision cannula to slide independently and freely, while the internal puncture needle and guidewire can be firmly fixed with one hand. This allows surgeons to perform multiple, forceful reciprocating cuts on the target tissue until the channel is fully dilated, even in cases involving scar adhesions or fascial hypertrophy, with minimal interference from the position of the internal puncture needle and guidewire. This feature significantly improves the success rate and efficiency of surgeries in challenging cases.

[0017] The cutting blade features a double-sided wedge-shaped spearhead design, combined with reciprocating cutting capabilities, enabling it to efficiently wedge and split the dense fascia layer, rather than simply slicing it open. This results in a cleaner tissue incision and more thorough expansion. This provides a smooth, low-resistance channel for subsequent placement of large-diameter treatment sheaths (such as 6F-24F), effectively avoiding complications such as difficulty in sheath advancement due to insufficient skin expansion or vascular wall tearing caused by forced placement. This improves the success rate of complex interventional procedures (such as large stents and valve replacement). Attached Figure Description

[0018] Figure 1 This is an exploded view of the coaxial double-layer cannula controllable skin-piercing puncture needle for vascular intervention described in this invention. Figure 2 This is a schematic diagram of the structure of the coaxial double-layer cannula controllable skin-piercing puncture needle for vascular intervention described in this invention; Figure 3 This is a schematic diagram of the structure of the protective protrusion described in this invention; Figure 4 This is a schematic diagram of the locking state of the coaxial double-layer cannula controllable skin-penetrating puncture needle for vascular intervention described in this invention; Figure 5 This is a schematic diagram of the unlocked state of the coaxial double-layer cannula controllable skin-piercing puncture needle for vascular intervention described in this invention.

[0019] In the diagram: 100 Handle, 110 Handle body, 120 Handle sleeve, 200 Inner puncture needle tube, 210 Protective protrusion, 300 Outer cutting tube body, 310 Cutting blade, 320 Finger pusher, 400 Locking mechanism, 410 Locking part, 411 Through hole, 420 Locking piece, 430 Anti-loss rope. Detailed Implementation

[0020] The following description is intended to disclose the present invention and enable those skilled in the art to implement it. The preferred embodiments described below are merely examples, and other obvious variations will occur to those skilled in the art. The basic principles of the invention defined in the following description can be applied to other embodiments, modifications, improvements, equivalents, and other technical solutions that do not depart from the spirit and scope of the invention.

[0021] Please refer to Figures 1 to 3 The present invention provides a coaxial double-layer cannula controllable skin-penetrating puncture needle for vascular intervention, comprising: Handle 100; An internal puncture needle 200, the proximal end of which is connected to the handle 100, and the distal end of which is a tip for puncture. An external incision tube body 300 is sleeved outside the internal puncture needle tube 200 and can slide along the axial direction of the internal puncture needle tube 200. A cutting blade 310 is provided at the distal end of the external incision tube body 300. At least one protective protrusion 210 is provided on the outer wall of the distal end of the internal puncture needle 200. The maximum radial dimension of the protective protrusion 210 is greater than the inner diameter of the external incision tube 300. It is used to block the external incision tube 300 in the axial direction to prevent the cutting edge of the external incision tube 300 from contacting the blood vessel wall.

[0022] During the puncture phase, the distal tip of the endovascular needle 200 is inserted into the blood vessel. After successful entry into the blood vessel lumen, the protective protrusion 210 is located on the outer side of the blood vessel wall, closely adhering to the adventitia.

[0023] When tissue incision is required, the operator pushes the outer incision cannula 300 distally (i.e., toward the patient's body) along the inner puncture needle cannula 200. The cutting edge 310 then moves forward to incise the tissue. However, because the maximum radial dimension of the protective protrusion 210 is larger than the inner diameter of the outer incision cannula 300, a rigid physical barrier is formed. When the outer incision cannula 300 slides to the point where the cutting edge 310 at its distal end abuts against the protective protrusion 210, its forward movement is forcibly terminated.

[0024] This not only safely integrates the functions of puncture and skin penetration into one, simplifying the operation steps. More importantly, it provides a passive and operator - experience - independent inherent safety mechanism, significantly enhancing the safety of vascular interventional puncture operations, especially suitable for interventional surgeries of deep large blood vessels such as the femoral artery.

[0025] As Figure 1 and Figure 2 shown, the inner puncture needle tube 200 is a slender hollow metal tube with its lumen running through the proximal and distal ends, and is used to insert and pass the guide wire used in interventional surgeries after successful puncture. The distal end of the inner puncture needle tube 200 is processed (such as grinding) into a tip for piercing tissue, preferably a standard bevel - cut needle tip, to facilitate penetrating the skin and blood vessel wall. Its proximal end is located on the extracorporeal operation side and is fixedly connected to the handle 100 in a non - relative - movement manner.

[0026] During use, the guide wire can be inserted through the proximal opening of the inner puncture needle tube 200, pass through its internal lumen, and finally exit from its distal opening and enter the blood vessel, thus establishing a track for the subsequent insertion of instruments.

[0027] The inner puncture needle tube 200 is preferably made of a material with good biocompatibility and mechanical properties, such as medical - grade 304 stainless steel. Its diameter specification can be selected according to clinical needs. In one embodiment, to adapt to commonly used interventional guide wires, its inner diameter can be designed to allow a standard guide wire of 0.035 inches (about 0.89 mm) to pass smoothly. Its overall specification can, for example, select a 18G puncture needle, and the corresponding outer diameter is about 1.27 mm to meet the need for establishing a passage in common interventional surgeries such as the femoral artery.

[0028] As Figure 1 and Figure 3 shown, on the outer wall of the distal end of the inner puncture needle tube 200, at least one protective protrusion 210 is integrally formed or fixedly provided. The protective protrusion 210 is a structure formed by the wall of the inner puncture needle tube 200 protruding radially outward.

[0029] The protective protrusion 210 has a front side facing the distal end (i.e., the puncture direction) and a rear side facing the proximal end (i.e., the handle direction). A first angle a is formed between the front side and the axial direction of the inner puncture needle tube 200, and a second angle b is formed between the rear side and the axial direction of the inner puncture needle tube 200. In this embodiment, the value of the first angle a is less than the value of the second angle b, that is, a < b. This makes the protective protrusion 210 in a streamlined blunt - round step shape with a gentle front and a steep rear. The gentle front side is conducive to reducing the resistance to subcutaneous tissue during puncture and enabling the protrusion 210 to smoothly reach and fit against the outer wall of the blood vessel; the steep rear side is used to form a rigid blocking surface.

[0030] The maximum outer diameter d formed radially by all the protective protrusions 210 must be greater than the inner diameter of the distal end of the external incision tube 300. Thus, when the external incision tube 300 is pushed forward to cut, the furthest axial stroke of its cutting edge 310 is forcibly terminated by the steep posterior side of the protective protrusions 210. Since the protective protrusions 210 themselves are located outside the vessel wall after successful puncture, this blocking mechanism ensures that the cutting edge 310 absolutely cannot contact the vessel wall, thereby eliminating the risk of accidental vessel puncture.

[0031] Regarding the arrangement of the protective protrusions 210, preferably, there are two protrusions, symmetrically arranged circumferentially along the inner puncture needle tube 200. They are located proximal to the distal end of the beveled needle tip of the inner puncture needle tube 200. In a specific example, this symmetrically arranged pair of protective protrusions 210 are located on the tube wall approximately 1.5 mm to 2.0 mm from the distal end of the beveled needle tip. This symmetrical arrangement helps to evenly distribute the blocking force circumferentially and ensures the stability of the blocking effect.

[0032] like Figure 1 and Figure 2 As shown, the external incision tube body 300 is a hollow tube that is coaxially arranged with the internal puncture needle tube 200 and sleeved on the outside of the internal puncture needle tube 200. The walls of the two tubes are precisely fitted with a clearance, which ensures that the external incision tube body 300 can slide along the axial direction on the outer wall of the internal puncture needle tube 200.

[0033] In a preferred embodiment, the body portion of the external incision cannula 300 is injection molded from medical-grade polyetheretherketone (PEEK) material, which possesses excellent biocompatibility, rigidity, toughness, and wear resistance. Its dimensions can be designed as follows: inner diameter 1.40 mm, outer diameter 3.00 mm. This dimensional design ensures sufficient thrust transmission rigidity for effectively cutting dense tissue while creating an optimized fit clearance with the internal puncture needle cannula 200 (e.g., an 18G needle with an outer diameter of 1.27 mm), achieving a balance between smooth sliding and precise operation.

[0034] At the distal end of the external incision cannula 300, a cutting blade 310 is fixedly disposed. This cutting blade 310 preferably employs a double-sided wedge-shaped design (resembling a spearhead), and its material can be heat-treated 440C high-carbon martensitic stainless steel with a hardness of 58 to 62 HRC to maintain long-term sharpness. This double-sided wedge-shaped blade is firmly integrated with the cannula body 300 as a single unit through processes such as insert injection molding. The double-sided wedge design allows it to efficiently cleave rather than simply cut tissue as it advances, making it particularly suitable for treating the dense fascia lata and Scarpa fascia in the femoral artery region. The resulting incision is clean and has a natural widening effect, significantly reducing resistance during subsequent insertion of large-diameter vascular sheaths, making sheath insertion smoother.

[0035] To facilitate the surgeon's application of force during the procedure, a pusher wing 320 is integrally formed at the proximal end (i.e., the side closest to the handle) of the external incision tube 300. The pusher wing 320 typically extends symmetrically to both sides of the tube, forming a pressure surface that facilitates finger pressure. By pressing the pusher wing 320, the surgeon can smoothly drive the entire external incision tube 300 forward along the internal puncture needle tube 200 to perform a cut, or retract it to prepare for the next cut. This user-friendly design greatly facilitates reciprocating cutting operations, allowing the surgeon to easily and controllably perform single or multiple cuts based on tissue resistance, thereby fully expanding the subcutaneous channel.

[0036] like Figure 1 and Figure 2 As shown, the handle 100 is connected to the proximal end of the internal puncture needle tube 200 and is located outside the body. The handle 100 is used for hand holding. In one embodiment, the handle 100 may be hollow, so that the guide wire can pass through the handle 100 and be inserted into the internal puncture needle tube 200.

[0037] like Figure 2 As shown, the handle 100 provides a secure grip for the operator and rigid support for the internal puncture needle 200. The proximal end of the internal puncture needle 200 is fixedly connected to the handle 100 in a manner that prevents relative movement (e.g., by gluing, crimping, or threading), making the two integral. Therefore, when the handle 100 is held and fixed, the position of the internal puncture needle 200 is also absolutely fixed.

[0038] In one specific embodiment, to adapt to standard interventional surgical procedures, the handle 100 can be designed as a hollow structure. Its hollow channel communicates with the proximal opening of the internal puncture needle 200, together forming a continuous, penetrating pathway through the proximal end of the instrument. This design allows the guidewire used in the interventional procedure to be directly inserted from the tail opening of the handle 100, sequentially passing through the hollow channel of the handle 100 and the lumen of the internal puncture needle 200, and finally exiting from its distal end into the blood vessel.

[0039] refer to Figure 2 The handle 100 includes a handle body 110 and a handle sleeve 120 connected to each other.

[0040] The handle sleeve 120 is a hollow tubular or cylindrical structure, which is fitted and fixed to the outside of the inner puncture needle tube 200. The proximal end of the inner puncture needle tube 200 passes through the internal cavity of the handle sleeve 120 and extends proximally (i.e., closer to the operator), ultimately achieving a fixed connection with the handle body 110 (e.g., through bonding, interference fit, or threaded connection). The handle body 110 constitutes the main gripping part of the handle 100.

[0041] An annular gap is provided between the inner wall of the handle sleeve 120 and the outer wall of the internal puncture needle 200. This gap is an intentional core structural design, its function being to provide a precise axial sliding channel and receiving space for the proximal end of the external incision tube 300. In the assembled and operating state of the instrument, the proximal portion of the external incision tube 300 is inserted into and received within this annular gap, and can slide smoothly along it. The finger pusher wing 320, located at the proximal end of the external incision tube 300, is designed with a radial dimension larger than the opening of this annular gap; therefore, the finger pusher wing 320 is always located on the outside of the handle sleeve 120.

[0042] like Figure 1 , Figures 3 to 5 As shown, to ensure safety and stability during the puncture procedure, the coaxial double-layer cannula controllable skin-piercing puncture needle for vascular intervention also includes a locking mechanism 400. When the locking mechanism 400 is in the locked state, it rigidly locks the handle 100 and the external incision tube body 300, completely preventing any relative movement between the two, so that the instrument functions like a standard puncture needle as a single unit during puncture.

[0043] The locking mechanism 400 includes a locking part 410 that cooperates with each other on the handle 100 and the externally cut tube body 300, and a separable locking member 420. When the locking member 420 engages with the cooperating locking part 410, the locking mechanism 400 is in the locked state.

[0044] In this embodiment, the mutually cooperating locking part 410 is specifically implemented as through holes 411 respectively formed on the handle 100 and the externally cut tube body 300. More specifically, as Figure 2 As shown, in the locked state, the proximal end of the external incision tube 300 is precisely inserted into the annular gap between the handle sleeve 120 and the internal puncture needle 200, and the distal end of the external incision tube 300 maintains a certain safe distance from the protective protrusion 210. At this time, the through hole 411 on the side wall of the handle sleeve 120 and the through hole 411 at the corresponding position on the proximal end of the external incision tube 300 are completely coaxially aligned in space.

[0045] The locking element 420 is a pin that can be inserted laterally into the pair of aligned through holes 411. When the pin is inserted and passes through the two holes, the handle sleeve 120 and the external incision tube 300 are rigidly connected and fixed in series, and cannot move relative to each other, and the instrument enters a locked state. After the pin is pulled out, the lock is released, and the external incision tube 300 gains the freedom to slide independently along the axial direction of the internal puncture needle tube 200.

[0046] The pin 420 can be designed as a slender cylindrical rigid rod. Its diameter, for example, can be set to 1.40 mm. Its surface is often coated with a bright color (such as red) as a visual warning sign.

[0047] The pin can be connected to the handle 100 via an anti-loss cord 430. The anti-loss cord 430 is a flexible rope, for example, about 80mm in length. One end is connected to the pull ring 421 near the end of the pin 420, and the other end is fixed to the main body of the handle 100 (usually the handle body 110). This anti-loss cord 430 ensures that even if the pin 420 is pulled out during operation, it remains connected to the handle 100 and will not completely detach, thus avoiding the risk of loss and complying with the management standards for sterile areas in operating rooms. It also allows for convenient access or temporary placement.

[0048] Taking femoral artery interventional surgery as a specific application scenario, the operation steps of the puncture needle of the present invention are as follows: Step 1, Preoperative Examination: The nurse hands the instruments to the operator. After removing the instruments, the operator first performs a visual inspection to confirm that the red safety pin 420 is in the fully inserted and locked position, and that the external slit cannula 300 is in the initial retracted proximal position (see [reference]). Figure 4 At the same time, check the overall appearance of the instrument to confirm that there is no damage. You can briefly pull out and reinsert the safety pin to verify by hand whether the outer tube can slide smoothly along the inner needle. After verification, be sure to ensure that the pin is reset and locked in place for puncture.

[0049] The second step, localization and anesthesia: The surgeon locates the point of strongest femoral artery pulsation in the groin area through palpation, or precisely positions the target femoral artery under real-time ultrasound guidance. Standard local infiltration anesthesia is then administered at the determined puncture site.

[0050] The third step, puncture: The operator firmly grips the handle 100, typically at an angle of approximately 45° to the skin, and inserts the needle towards the predetermined puncture point. Since the safety pin 420 rigidly locks the handle and outer tube at this point, the instrument moves as a single unit, and the puncture feel is completely consistent with a conventional single-lumen puncture needle. The tip of the inner puncture needle 200 sequentially penetrates the skin, subcutaneous fat, and various layers of fascia, finally piercing the anterior wall of the femoral artery and entering the lumen. When bright red arterial blood is observed pulsatingly ejected from the proximal end of the inner puncture needle 200 (or through the transparent handle), it is confirmed that the tip of the inner puncture needle 200 has successfully entered the lumen of the femoral artery.

[0051] Step 4: Insert the guidewire. Keep the handle 100 in an absolutely stable position, avoiding any movement. Insert a 0.035-inch standard interventional guidewire into the lumen of the internal puncture needle 200 through the opening at the tail of the handle 100 (or directly through the lumen of the internal puncture needle 200). Under X-ray fluoroscopy or ultrasound guidance, confirm that the guidewire has successfully advanced a certain distance distally along the femoral artery lumen, is well-positioned, and faces no resistance.

[0052] Step 5, Unlock: The operator firmly holds the handle 100 with one hand, ensuring that the internal puncture needle 200 and its tip do not move (at this point, the protective protrusion 210 of the needle tip should be inside the femoral artery lumen as the tip enters). Using the thumb and forefinger of the other hand, the operator pinches the pull ring at the end of the red safety pin 420 and smoothly pulls it completely and laterally out of the through-hole of the handle sleeve 120. At this point, the locking mechanism 400 is released, and the external incision tube 300 gains complete axial freedom of movement, while the internal puncture needle 200 remains absolutely still under the operator's control.

[0053] Step 6, Controlled skin expansion: The surgeon uses their thumb or forefinger to press the pusher wing 320 at the proximal end of the external incision tube 300, and smoothly pushes the tube distally (i.e., towards the patient's body). The cutting blade 310 then moves forward, sequentially cutting through the epidermis, dermis, and subcutaneous fat tissue at the puncture point, and finally acting on the dense inguinal fascia and Scarpa fascia.

[0054] If the surgeon experiences significant and persistent resistance during the initial advancement, indicating that the deep fascia has not been adequately cut, the external incision cannula 300 can be moderately retracted proximally along the internal puncture needle 200 before being advanced again. This reciprocating motion can be repeated multiple times. Throughout the entire reciprocating process, the internal puncture needle 200 and the guide wire within its lumen remain completely stationary, with the handle fixed, and the three-dimensional position of the puncture point remains unchanged. The surgeon can adjust the number of reciprocating cuts based on changes in tissue resistance until a clear breakthrough sensation of adequate fascia incision is felt. This function offers significant advantages for difficult skin expansion cases, such as those with surgical scars, tissue adhesions, fascial calcification, or obesity in the groin area.

[0055] Each time the external incision tube 300 is advanced until its cutting edge 310 contacts the steep posterior side of the protective protrusion 210 on the internal puncture needle 200, a sudden and significant increase in thrust is felt, forcibly terminating the movement of the external tube. This is the absolutely safe cutting boundary set by this device. Below this boundary, the anterior wall of the femoral artery is well protected because it is located distal to the protective protrusion 210 and will not be damaged by the cutting edge. At the same time, since the guidewire remains inside the lumen of the internal puncture needle 200 and is completely isolated from the external tube and cutting edge moving on the outer wall, the guidewire is absolutely safe throughout the entire cutting process and there is no risk of it being cut.

[0056] Step 7: Remove the needle and insert a vascular sheath. After confirming that the puncture site has been sufficiently dilated, the operator pinches the handle 100 and withdraws the entire puncture needle (including the internal puncture needle tube 200 and the external incision tube body 300) as a whole, simultaneously along the guidewire, leaving only the guidewire inside the blood vessel. Because the skin and deep fascia have been sufficiently incised, the resistance encountered when subsequently inserting the required vascular sheath (sizes can range from 6F to 24F, etc.) along the guidewire is minimal. The sheath can smoothly pass through the subcutaneous channel into the blood vessel, usually without the need for additional channel dilation, improving operational efficiency and reducing the risk of complications such as vascular injury and sheath deformation due to difficulty in sheath placement.

[0057] Step 8, Subsequent Operations: After successful insertion of the vascular sheath, subsequent vascular interventional procedures can be performed as planned. This puncture needle is designed for single-use medical devices and should be disposed of in accordance with relevant medical waste management regulations after use.

[0058] The embodiments described above are only used to illustrate the technical ideas and features of the present invention. Their purpose is to enable those skilled in the art to understand the content of the present invention and implement it accordingly. The scope of patent application of the present invention should not be limited by these embodiments. That is, any equivalent changes or modifications made in accordance with the spirit disclosed in the present invention still fall within the patent scope of the present invention.

Claims

1. A coaxial double-layer cannula controllable skin-penetrating puncture needle for vascular intervention, characterized in that, include: Handle (100); An internal puncture needle (200) is provided, the proximal end of which is connected to the handle (100), and the distal end of which is a tip for puncture. An external incision tube body (300) is sleeved outside the internal puncture needle tube (200) and can slide along the axial direction of the internal puncture needle tube (200). The distal end of the external incision tube body (300) is provided with a cutting blade (310). At least one protective protrusion (210) is provided on the outer wall of the distal end of the internal puncture needle (200). The maximum radial dimension of the protective protrusion (210) is greater than the inner diameter of the external incision tube body (300). It is used to block the external incision tube body (300) in the axial direction to prevent the cutting edge of the external incision tube body (300) from contacting the blood vessel wall.

2. The coaxial double-layer cannula controllable skin-piercing puncture needle for vascular intervention as described in claim 1, characterized in that, The number of the protective protrusions (210) is two, and they are arranged circumferentially along the internal puncture needle tube (200).

3. The coaxial double-layer cannula controllable skin-piercing puncture needle for vascular intervention as described in claim 1, characterized in that, The protective protrusion (210) has a frontal side facing the distal end of the internal puncture needle (200) and a rearal side facing the proximal end of the internal puncture needle (200); Wherein, the front side of the protective protrusion (210) forms a first included angle a with the axial direction of the internal puncture needle tube (200), and the rear side of the protective protrusion (210) forms a second included angle b with the axial direction of the internal puncture needle tube (200); The first included angle a is smaller than the second included angle b.

4. The coaxial double-layer cannula controllable skin-piercing puncture needle for vascular intervention as described in claim 1, characterized in that, It also includes a locking mechanism (400), which, when in a locked state, locks the handle (100) and the externally cut tube body (300) to prevent relative movement between them.

5. The coaxial double-layer cannula controllable skin-piercing puncture needle for vascular intervention as described in claim 4, characterized in that, The locking mechanism (400) includes a locking part (410) that cooperates with each other on the handle (100) and the outer cut tube body (300), and a separable locking member (420). When the locking member (420) engages with the cooperating locking part (410), the locking mechanism (400) is in the locked state.

6. The coaxial double-layer cannula controllable skin-penetrating puncture needle for vascular intervention as described in claim 5, characterized in that, The locking part (410) that cooperates with each other is a through hole (411) respectively provided on the handle (100) and the outer cut tube body (300), and the locking member (420) is a pin that can be inserted into the through hole.

7. The coaxial double-layer cannula controllable skin-penetrating puncture needle for vascular intervention as described in claim 5, characterized in that, The locking element (420) is connected to the handle (100) via an anti-loss rope (430).

8. The coaxial double-layer cannula controllable skin-penetrating puncture needle for vascular intervention as described in claim 1, characterized in that, The cutting edge (310) is a double-sided wedge-shaped edge.

9. The coaxial double-layer cannula controllable skin-penetrating puncture needle for vascular intervention as described in claim 1, characterized in that, The proximal end of the externally cut tube body (300) is provided with a finger pusher (320) for finger pushing.

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