Puncture member having a puncture needle body and atrial septum puncture guidewire

Abstract

To provide a puncture member having a puncture needle body and an atrial septal puncture guide wire so that the atrial septum can be easily punctured with the puncture needle body, and the risk of scratching or ripping the left endocardium, the left atrial appendage and pulmonary veins can also be reduced.SOLUTION: A puncture member having a puncture needle body comprises a puncture needle body 1, a puncture body 2 and a connecting portion 3 that are integrally formed and sequentially connected. The puncture needle body is a long straight structure having a puncture tip. The puncture body is an arc structure having a central angle greater than or equal to 180°, and the puncture body is stretched to form a horizontal structure when loaded, and returns to the arc structure when unloaded.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] The present invention relates to the technical field of intracardiac interventional medical devices, and more particularly to a puncture member having a puncture needle body for puncturing the atrial septum and an atrial septum puncture guidewire. [Background technology]

[0002] Atrial septal puncture is a necessary route in cardiac interventional procedures to access the left atrium from outside the body via the right atrium. For example, mitral valve balloon dilation, atrial fibrillation radiofrequency ablation, etc., all require atrial septal puncture first. Puncture of the atrial septum is the first step in successful surgery. Because the left side of the atrial septum faces the pulmonary vein ostium and the left atrial endocardium, atrial septal puncture requires high puncture force, puncture feel, and puncture accuracy.

[0003]

[0003] Currently, the instruments used to achieve the atrial septum puncture function are mainly atrial septum puncture needles and atrial septum puncture guidewires. The puncture tip of the atrial septum puncture needle is relatively thick, requiring a large puncture force during puncture. Furthermore, because the tip of the atrial septum puncture needle faces the left atrial endocardium or the left atrial atrial appendage, there is a high risk of accidentally puncturing the left atrial endocardium or the left atrial atrial appendage, and the left atrial endocardium and the left atrial atrial appendage can easily be punctured or penetrated, requiring the operator to have high surgical skills. For this reason, the atrial septum puncture needle does not have a surgical method for inserting into the pulmonary vein. The puncture tip of an atrial septum puncture guide wire is relatively thin, does not require a large puncture force when puncturing, the operator feels a weak puncture sensation, it is difficult to know whether the puncture guide wire has pierced the atrial septum, and there is a high risk of erroneous puncture.In addition, the tip of the needle is tilted outward, which increases the risk of tearing or damaging the left atrial endocardium and left atrial atrial appendage during puncture or when entering the pulmonary vein, and also increases the risk of tearing or damaging the pulmonary vein when removing it from the pulmonary vein.

[0004] Currently, the technical problems existing in the prior art cannot be overcome. Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, an object of the present invention is to provide a puncture member and an atrial septum puncture guide wire having a puncture needle body that can easily puncture the atrial septum with the puncture needle body and that can reduce the risk of tearing or damaging the left atrial endocardium, left atrial ear, or pulmonary vein. [Means for solving the problem]

[0006] According to one aspect of the present invention, a puncture member having a puncture needle body includes a puncture needle body, a puncture main body, and a connecting part that are integrally molded and connected in sequence, the puncture needle body has an elongated structure with a puncture tip, and the puncture main body has an arc structure with a central angle of 180° or more, and extends to a horizontal structure when loaded and returns to the arc structure when unloaded.

[0007] According to another aspect of the present invention, there is provided an atrial septum puncture guidewire comprising a puncture member having the above-mentioned puncture needle body and a horizontally extending guidewire body, wherein the connection portion of the puncture member having the puncture needle body is aligned with and fixedly connected to the tip of the guidewire body.

[0008] [Effects of the invention] The embodiments of the present disclosure disclose a puncture member and an atrial septum puncture guidewire having a puncture needle body of the present disclosure, which are provided with a long puncture needle body and an arc-shaped puncture body, so that the atrial septum can be easily pierced with support from the puncture needle body, and the risk of damaging or tearing the left atrial endocardium, left atrial ear, and pulmonary veins can be reduced.

[0009] Additional advantages, objects, and features of the present disclosure will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art upon study of the following, or may be learned by practice of the present disclosure. The objectives and other advantages of the present disclosure may be realized and attained by the structure particularly pointed out in the written description and claims hereof, as well as the appended drawings.

[0010] The technical problems to be achieved by the present invention are not limited to those mentioned above, and other technical problems not mentioned will be clearly understood by those skilled in the art to which the present invention pertains from the following description.

[0011] The drawings described herein are included to provide a further understanding of the present disclosure, constitute a part of the present disclosure, and do not constitute limitations thereon. The components in the drawings are not drawn to scale, but merely serve to illustrate the principles of the present disclosure. To facilitate illustrating and explaining portions of the present disclosure, corresponding portions of the drawings may be exaggerated, i.e., larger than other components in an exemplary system actually manufactured according to the present disclosure. [Brief explanation of the drawings]

[0012] [Figure 1A] 1 is a structural schematic diagram of an embodiment of a puncture member having a puncture needle body of the present invention. [Figure 1B] FIG. 1B is a schematic diagram of a partial cross-sectional structure of FIG. 1A. [Figure 1C] FIG. 2 is a cross-sectional view taken along line AA in FIG. 1B. [Figure 1D] FIG. 1C is an enlarged view of region B in FIG. 1B. [Figure 1E] 1 is a structural schematic diagram of an embodiment of the puncture member of the present invention in an extended state. [Figure 2] 10A and 10B are structural schematic diagrams of another embodiment of the puncture member of the present invention. [Figure 3A] 10A and 10B are schematic diagrams showing the structure of a puncture member having a puncture needle body according to another embodiment of the present invention. [Figure 3B] FIG. 3B is an enlarged view of region C in FIG. 3A. [Figure 4A] 1 is a structural schematic diagram of one embodiment of an atrial septal puncture guidewire of the present disclosure. FIG. [Figure 4B] 1 is a structural diagram of an embodiment of an atrial septal puncture guidewire in an expanded state according to the present disclosure. FIG. [Figure 5] 1 is a schematic diagram of a sheath and dilator for umbrella-like dilation of the interatrial septum in the right atrium. [Figure 6A] FIG. 10 is a diagram showing an embodiment of the atrial septal puncture guidewire of the present invention fitted with an atrial septal puncture needle and a dilator, and the atrial septal puncture guidewire of the present invention positioned within the atrial septal puncture needle. [Figure 6B] FIG. 6B is an enlarged view of region D in FIG. 6A. [Figure 7A] FIG. 10 is a diagram showing one embodiment of the atrial septal puncture guidewire of the present invention fitted to an atrial septal puncture needle and a dilator, with the atrial septal puncture guidewire of the present invention extending from the atrial septal puncture needle and positioned within the dilator. [Figure 7B] FIG. 7B is an enlarged view of region E in FIG. 7A. [Figure 8A] 1 is a schematic diagram of an embodiment of the presently disclosed atrial septal puncture guidewire in combination with an atrial septal puncture needle and a dilator, with the atrial septal puncture guidewire fully extended from the dilator. FIG. [Figure 8B] FIG. 8B is an enlarged view of region F in FIG. 8A. [Figure 9] 1 is a diagram illustrating an embodiment of an atrial septal puncture guidewire at the ostium of a pulmonary vein. FIG.

[0013] 1—puncture needle body; 11—first puncture surface; 111—first puncture plane surface; 112—first puncture arc surface; 12—second puncture surface; 13—support portion; 14—retreat arc surface. 2 - piercing body, 21 - linear extension, 23 - horizontal extension.

[0014] According to another aspect of the invention, the method includes connecting the connector at the first angle φ1 - first angle φ2 - second angle φ3 - third angle φ3.

[0015] 10—Puncture member having a puncture needle body 20—Guide wire body 201—Position marker ring 202—Radiopaque coil.

[0016] 100 - Atrial septal puncture guidewire, 200 - Atrial septal puncture needle, 300 - Dilator, 400 - Fixed curvature sheath, 500 - Controlled curvature sheath. DETAILED DESCRIPTION OF THE INVENTION

[0017] In order to clarify the objectives, technical aspects, and advantages of the embodiments of the present invention, the embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Here, the embodiments and the description thereof are for explaining the present invention, but are not intended to limit the present invention.

[0018] Here, in order to avoid obscuring the present disclosure with unnecessary details, only structures and / or processing steps closely related to the solutions of the present disclosure are shown, and detailed descriptions of other parts are omitted.

[0019] It is emphasized that where the term "comprises / includes / has" is used in this specification, it denotes the presence of a feature, element, step or component but does not exclude the presence or addition of one or more other features, elements, steps or components.

[0020] Furthermore, in this specification, directional terms such as "up" and "down" indicate the orientation of positions shown in the accompanying drawings, and the term "connection" refers not only to a direct connection but also to an indirect connection via an intermediate body, unless otherwise specified. A direct connection refers to a connection between two components without an intermediate body, and an indirect connection refers to a connection between two components via an intermediate body.

[0021] In this disclosure, the distal end refers to the end away from the operator (which is also the end closer to the heart), and the distal end refers to the end closer to the operator.

[0022] The present disclosure provides a puncturing member having a puncturing needle body, which comprises a puncturing needle body 1, a puncturing main body 2, and a connecting part 3, which are formed sequentially and integrally. The puncturing needle body 1 has an elongated structure with a puncturing tip. The puncturing main body 2 has an arc-shaped structure with a central angle of 180° or more, which can extend to a horizontal position during loading and return to the arc-shaped position during unloading.

[0023] As can be seen from the above description, the puncture member having the puncture needle body 1 of the present invention is made of a material that has high superelasticity and is compatible in various aspects with interventional medical devices. For example, a material such as a conventional nickel-titanium alloy can be used, which can stretch horizontally when loaded and recover when the load is removed.

[0024] The puncture member having the puncture needle body 1 of the present invention is provided with a long puncture needle body 1, which provides sufficient support for the puncture tip and has an excellent puncture force transmission function, allowing the puncture tip to puncture the atrial septum without using a relatively large puncture force. Furthermore, the arc-shaped puncture body 2 allows the puncture member having the puncture needle body 1 of the present invention to be extended horizontally, allowing it to smoothly reach the position of the atrial septum through the inner cavity of the cooperating device (generally a dilator) used, and to gently restore to its arc-shaped structure after puncturing the atrial septum, allowing the puncture body 2 to enter from the right atrium to the left atrium using its arc-shaped outer wall, preventing accidental puncture of the left atrial endocardium and left atrial ear. As a result, the arcuate outer wall surface does not damage or tear the pulmonary vein during the process of entering the pulmonary vein, and the puncture needle body 1 is always parallel to or directed toward the extension line of the connecting part 3, preventing damage or tearing of the left atrial endocardium and left atrial ear. Furthermore, when withdrawn from the pulmonary vein, the puncture needle body 1 is always directed parallel to or directed toward the extension line of the connecting part 3, so that even if the puncture body 2 abuts against the pulmonary vein ostium, the puncture needle body 1 simply displaces along or approaches the extension line of the connecting part 3, and is able to move away from the left atrial endocardium and left atrial ear, preventing damage or tearing of the left atrial endocardium and left atrial ear. Furthermore, because the puncture member including the puncture needle body 1 has an integrated structure, stability during use is sufficiently ensured. As described above, the puncture member equipped with the puncture needle body 1 of the present invention is provided with a long puncture needle body 1 and an arc-shaped puncture body 2, which reduces the risk of damaging or tearing the left atrial endocardium, left atrial ear, and pulmonary vein, while allowing the puncture needle body 1 to easily puncture the atrial septum.

[0025] The structure of the puncture needle body 1 will be described below using Figs. 1A to 3B as examples.

[0026] The thinner the puncture tip formed on the puncture needle body 1, the more likely it is to become ineffective due to breakage or other reasons during manufacturing, packaging, transportation, and use. In particular, if the puncture tip breaks inside the heart during use, it can cause a very serious accident. If the puncture tip formed on the puncture needle body 1 becomes too blunt, a large puncture force must be applied to puncture the atrial septum, which not only increases the difficulty of the surgery but also increases the risk of the surgery.

[0027] As shown in FIG. 1C , the projection of the tip of the puncture needle body 1 onto a horizontal plane forms a first angle φ1 between 10° and 30°. By providing a certain width to the tip of the puncture needle body 1, on the one hand, it is possible to effectively prevent the puncture tip from failing. On the other hand, it is possible to form a puncture hole of a certain width when the puncture tip punctures the interatrial septal space and slowly bounces back to its original position after puncturing the interatrial septal space. This allows the puncture needle body 1 to more easily pass through the puncture hole in accordance with the instrument (usually a dilator). Furthermore, the width of the puncture needle body 1 still allows the interatrial septal space to be punctured with a small puncture force. In the three preferred embodiments of the present disclosure, the first angle φ1 is set to 28°. However, this does not affect the technical effect that can be achieved even if the first angle φ1 is slightly greater than 30°. Therefore, even if the first angle φ1 is slightly less than 10° or slightly greater than 30°, it is still within the scope of protection of the present disclosure.

[0028] 1D and 3B, the projection of the tip of the puncture needle body 1 onto the vertical plane may form a second angle φ2 of 10° or more and 30° or less. In the two embodiments shown in FIGS. 1A to 1E and 2, a first puncture plane 11 is formed from the tip of the puncture needle body 1 to the end of the puncture needle body 1, with a first puncture plane 111 and a first puncture arc 112 connected in sequence. The second angle φ2 is selected to be 30° to form a relatively large puncture hole, allowing not only smooth passage of a cooperating device (generally a dilator) but also passage of an access device with a relatively large diameter (e.g., a sheath), and thus the puncture arc 112 is used to ensure smooth progression during the rebound process of the atrial septum. In the embodiment shown in Figures 3A and 3B, a second puncture surface 12 with a planar structure is formed from the tip of the puncture needle 1 to the end of the puncture needle 1, and the second angle φ2 is 15°, ensuring the sharpness of the puncture needle 1 and puncturing the atrial septum with the smallest possible puncture force, thereby reducing the difficulty of the surgery.

[0029] Alternatively, if the projection of the tip of the puncture needle 1 onto a horizontal plane forms a first angle φ1 of 10° to 30° and the projection of the tip of the puncture needle 1 onto a vertical plane forms a second angle φ2 of 10° to 30°, the second angle φ2 can be realized using the first puncturing surface 11 or the second puncturing surface 12, forming a conical puncturing tip on the puncture needle 1. This provides a strong puncturing sensation when the puncture needle 1 punctures the atrial septum, i.e., the operator can clearly feel that the puncture needle 1 has punctured the atrial septum and completed the puncture. Furthermore, even after puncturing the umbrella-shaped atrial septum (see FIG. 5), the puncture needle 1 can smoothly and quickly return to its original position (the initial position where it is not attached) along the first puncturing surface 11 or the second puncturing surface 12. Furthermore, the puncturing force required by the puncture needle 1 is still small. These embodiments all ensure that the puncture needle body 1 can puncture the atrial septum relatively easily and that the puncture tip can be effectively prevented from becoming ineffective.

[0030] In an alternative embodiment, the projection of the tip of the puncture needle body 1 onto the centerline of the connecting portion 3 is on an extension of the connecting portion 3. Conventional puncture guidewires have a long U-shaped puncture portion, and the projection of the puncture tip of the atrial septum puncture guidewire onto the centerline of the connecting portion is on the connecting portion. When an operator holds the proximal end of the body and pushes it, the operator must apply a large puncture force to complete the puncture. After the atrial septum puncture, the puncture guidewire is pushed directly into the left atrium due to inertia, increasing the risk of damaging or tearing the left atrial endocardium. Therefore, the puncture device equipped with the puncture needle body of the present disclosure has a shorter connecting portion 3, enabling atrial septum puncture with a small puncture force while significantly reducing the risk of damaging or tearing the left atrial endocardium.

[0031] The end of the puncture needle body 1 may further form a support part with a tubular or columnar structure, and the end of the support part may contact the tip of the puncture body 2, thereby increasing the support force of the puncture needle body 1 by the puncture body 2. To increase This also helps to maintain the stability of the puncture needle 1 and transmit the puncture force to the puncture tip of the puncture needle 1. Considering safety when the puncture needle 1 is withdrawn from the distal opening of a collaborative device (typically an extension tube) into the lumen of the collaborative device, it is preferable to form a retracted arc surface between the end of the support portion and the puncture body 2 to ensure a smooth transition during withdrawal and to prevent the end of the support portion from interfering with the distal opening of the collaborative device. If the end of the puncture needle 1 forms a tubular support portion 13, a developing portion made of a developing material can be fitted into the lumen of the support portion 13. This improves the X-ray developability of the puncture needle 1, helps the operator accurately determine the position of the puncture needle 1 within the heart during use, and improves operational safety. Specifically, as shown in Figures 1B and 1E, a retracted arc surface 14 is formed at the end of the tubular support portion 13.

[0032] The configuration of the puncture body 2 will be described below using Figs. 1 to 3 as examples.

[0033] In its initial state, the puncture body 2 of the puncture member comprising the puncture needle body of the present disclosure has an arc-shaped structure with a central angle greater than 180° as shown in Figures 1A and 3A, or an arc-shaped structure with a central angle equal to 180° as shown in Figure 2. Taking the embodiment shown in Figure 1A as an example, during use, the puncture body 2 is fitted into the lumen of a cooperating device (generally a dilator), and when the puncture body 2 applies a load to the inner wall of the cooperating device, the puncture member comprising the puncture needle body 1 of the present disclosure extends and passes through the lumen of the cooperating device in a substantially horizontal state as shown in Figure 1E, and the puncture needle body 1 enters the left atrium from the distal opening of the cooperating device, puncturing the atrial septum, and the puncture body 2 gradually returns to its arc-shaped structure as the puncture needle body 1 gradually enters the left atrium. If the curved outer side of the puncture body 2 collides with the left atrial endocardium and / or the left atrial ear (i.e., the curved outer side of the puncture body encounters resistance), the puncture tip of the puncture needle body 1 will be displaced in a direction parallel to the connecting part 3 or in a direction toward the connecting part 3, and even if it moves in the direction in which the opening of the puncture body 2 converges, it will stay away from the left atrial endocardium throughout the entire process, significantly reducing the risk of puncturing or piercing the left atrial endocardium. The puncture body 2 continues to enter the left atrium until the curved outer side of the puncture body 2 enters the pulmonary vein, and if the curved outer side of the puncture body 2 collides with the inner wall of the pulmonary vein (i.e., the curved outer side of the puncture body encounters resistance), the puncture needle body 1 will continue to be displaced along the extension of the connecting part 3 or in the direction in which the opening of the puncture body 2 converges, and will stay away from the left atrial ear, significantly reducing the risk of puncturing or piercing the left atrial ear. The puncture body 2 continues to advance into the pulmonary vein, and after establishing a passage from the outside of the body to the left atrium, it is retracted from the pulmonary vein. During this process, if the curved outer side of the puncture body 2 collides with the inner wall of the pulmonary vein (i.e., if the curved outer side of the puncture body encounters resistance), the puncture needle body 1 continues to move in the direction in which the opening of the puncture body 2 converges, and does not come into contact with the pulmonary vein intima, thereby significantly reducing the risk of puncturing or piercing the pulmonary vein. Therefore, by employing the puncture needle body 1 and the puncture body 2, the puncture device with a needle body of the present disclosure, if the curved outer side of the puncture body 2 encounters resistance during the process of entering the left atrium and the pulmonary vein, the puncture needle tip will be displaced toward the connecting part 3 or in the direction in which the opening of the puncture body 2 converges, and will move away from the left atrial endocardium, left atrial ear, and pulmonary vein, significantly reducing the risk of puncturing or piercing the left atrial endocardium, left atrial ear, and pulmonary vein.

[0034] In a specific embodiment, the distal end of the puncture body 2 extends to form a linear extension section 21, which abuts the distal end of the puncture needle body 1, and / or the distal end of the puncture body 2 extends to form a horizontal extension section 23, which abuts the connecting section 3, thereby realizing an integrally molded structure of the puncture member equipped with the puncture needle body of the present disclosure, ensuring the stability of the overall structure, and improving the safety of puncturing blood vessels and the heart. For example, in the specific embodiment shown in Figures 1A to 1E, a third angle φ3 of 10° to 30° is formed between the extension line of the linear extension section 21 and the extension line of the horizontal extension section 23. Referring to Figures 1B and 1E, according to the basic principles of plane geometry, the central angle of the puncture body 2 is the sum of the third angle φ3 and 180°, i.e., the central angle of the puncture body 2 with respect to the third angle φ3 is limited to 190° to 220°. Preferably, the third angle φ3 is set to 15°, so that the overall performance of the stretched state and puncture performance of the puncture main body 2 is good.

[0035] The connecting portion 3 can be tubular or columnar so that the connecting guidewire forms a puncture guidewire. In any embodiment of the present disclosure, the puncture member having the puncture needle body has a planar symmetrical structure with a vertical plane as the plane of symmetry, so that the puncture members having the puncture needle body are located on the same plane. This allows the operator to determine the orientation of the puncture tip of the puncture needle body 1 through the control end during use, reduces the torque generated when using the puncture member having the puncture needle body, and improves operational safety. It is preferable that the outer diameter of the puncture needle body 1, the outer diameter of the puncture body 2, and the outer diameter of the connecting portion 3 are the same length, and that the inner diameter of the puncture needle body 1, the inner diameter of the puncture body 2, and the inner diameter of the connecting portion 3 are the same length, and / or the cross section of the puncture needle body 1 has an arc-shaped structure, which is advantageous for simplifying the manufacturing process.

[0036] In specific embodiments shown in FIGS. 1A to 1E, the present invention provides a puncture member comprising a puncture needle body that forms a planar symmetric structure having a plane of symmetry as a vertical plane.

[0037] The cross section of the puncture needle 1 has an arc-shaped structure, and on a horizontal plane, the projection of the tip of the puncture needle 1 forms an angle of 28°. On a vertical plane, from the tip of the puncture needle 1 to the end of the puncture needle 1, a first puncture surface 11 is formed by the connection of a first puncture plane 111 and a first puncture arc surface 112 in sequence, and an angle of 30° is formed between the first puncture plane 111 and the horizontal plane. The end of the puncture needle 1 forms a tubular support part 13, and the end of the support part 13 forms a receding arc surface 14. The developing member is fitted into the inner cavity of the support portion 13 .

[0038] The tip of the puncture body 2 extends to form a linear extension portion 21, which forms an angle of 15° with the horizontal plane, the tip of the linear extension portion 21 connects to the receding arc surface 14, and the end of the puncture body 2 connects to the connection portion 3.

[0039] The connecting part 3 has a tubular structure, and the projection of the tip of the puncture needle body 1 onto the center line of the connecting part 3 is on an extension line of the connecting part 3.

[0040] The outer diameter of the puncture needle 1, the outer diameter of the puncture body 2 and the outer diameter of the connecting part 3 are the same length, and the inner diameter of the puncture needle 1, the inner diameter of the puncture body 2 and the inner diameter of the connecting part 3 are the same length.

[0041] In one embodiment, the present disclosure further provides an atrial septum puncture guide comprising a puncture member having a puncture needle body as described above and a horizontally extending guidewire body, wherein a connecting portion of the puncture member having the puncture needle body is aligned and fixedly connected to a tip of the guidewire body. Specifically, the connecting portion of the puncture member having the puncture needle body has a tubular structure, and the tip of the guidewire body has a columnar structure, and the tip of the guidewire body is aligned and fitted into the connecting portion. Alternatively, the connecting portion of the puncture member having the puncture needle body may have a columnar structure, and the tip of the guidewire body has a tubular structure, and the tip of the guidewire body may be aligned and fitted outside the connecting portion.

[0042] Hereinafter, using one embodiment of the atrial septum puncture guide wire according to the present disclosure as shown in Figures 4A and 4B, the process in which the atrial septum puncture guide wire according to the present disclosure exits the dilator and punctures the atrial septum will be described. Here, the atrial septum puncture guidewire 100 comprises a puncture member 10 having the puncture needle body, and a guidewire body 20, and the guidewire body 20 comprises a first segment, a tapered connecting segment, and a second segment having a smaller diameter than the first segment, which are integrally molded in this order from the end to the tip; and / or the end of the guidewire body 20 is provided with at least one position marking ring 201 to assist the operator in determining the position at which the guidewire body 20 enters a collaborative device (generally a dilator), thereby determining the specific position of the puncture needle body 1 within the collaborative device; and / or the end of the guidewire body 20 is provided with a radiopaque coil 202 to improve X-ray developability; and / or the end of the guidewire body 20 is provided with an orientation plate that matches the orientation of the puncture needle body 1, and the operator can determine the orientation of the puncture needle body 1 relative to the guidewire body 20 based on the direction of the orientation plate. As a puncture member having a puncture needle body, an example of a puncture member having a puncture needle body according to the present disclosure as shown in FIGS. 1A to 1E is used.

[0043] Example 1: The cooperating medical devices are an atrial septal puncture needle 200, a dilator 300, and a fixation curved sheath 400.

[0044] In actual use, as shown in Fig. 5, the dilator 300 is first inserted into the fixed curve sheath 400 to form a dilator assembly. The dilator assembly enters the right atrium and opens the atrial septum in an approximately umbrella-like shape (e.g., enters through the inferior vena cava, pushes into the superior vena cava, slides down to the atrial septum, pushes in the dilator assembly, and tightens the atrial septum in an approximately umbrella-like shape).

[0045] As shown in Figures 6A and 6B, the atrial septum puncture guidewire 100 of the present disclosure is placed inside the atrial septum puncture needle 200 to form a puncture needle assembly, and while the fixed curved sheath 400 and dilator 300 are kept fixed, the puncture needle assembly is placed over the dilator 300 and pushed out until the atrial septum puncture needle 200 hits the reduced diameter portion at the tip of the dilator 300, and the tip of the atrial septum puncture guidewire 100 approaches the tip of the atrial septum puncture needle 200.

[0046] As shown in Figures 7A and 7B, the atrial septum puncture guide wire 100 of the present disclosure is further advanced so that it is ready for puncture, and the puncture member 10 having the puncture needle body exits from the distal opening of the atrial septum puncture needle 200 and approaches the distal opening of the dilator 300.

[0047] The atrial septum puncture guidewire 100 is gradually advanced until it protrudes from the distal end outlet of the dilator 300, and as the atrial septum puncture guidewire 100 is further advanced, the puncture needle body 1 of the puncture member 10 having the puncture needle body gradually protrudes from the distal end outlet of the dilator 300 and punctures the atrial septum, which then rebounds and the dilator 300 passes through the atrial septum. Further, as shown in Figures 8A and 8B, the atrial septum puncture guidewire 100 is advanced until the puncture member 10 having the puncture needle body completely protrudes from the dilator 300 and gradually returns to its arc shape.

[0048] The puncture member 10 having the lung puncture needle body is advanced to enter the venous opening, and the atrial septum puncture guidewire 100 is fixed and the dilator 300 and the fixing sheath 400 are advanced continuously to continue accessing the left atrium along the atrial septum puncture guidewire 100, the dilator 300 and the fixing sheath 400, and at the same time, the dilator 300, the atrial septum puncture needle 200 and the atrial septum puncture guidewire 100 exit from the fixing sheath 400.

[0049] As described above, atrial septal puncture was completed, and access to the left atrium from outside the body was established.

[0050] Example 2: The collaborative medical devices are a dilator 300 and a controllably curved sheath 500.

[0051] The initial stage is the same as in Example 1. The dilator 300 fits into the controllable sheath 500 to form a separate dilator assembly, which enters the right atrium and opens the atrial septum in a roughly umbrella-like fashion.

[0052] The atrial septum puncture guidewire 100 is passed directly through the dilator 300 and reaches the distal opening of the dilator 300, ready for puncture. The atrial septum puncture guidewire 100 is then advanced to puncture the atrial septum, which then springs back (rebounds) and the dilator 300 passes through the atrial septum. The atrial septum puncture guidewire 100 continues to advance until the puncturing member 10 with the puncture needle body completely protrudes from the dilator 300 and gradually returns to its arc shape.

[0053] Next, the puncture member 10 having the puncture needle body is advanced to enter the pulmonary vein ostium, the atrial septum puncture guidewire 100 is fixed, and the dilator 300 and the controllable bending sheath 500 are advanced. The atrial septum puncture guidewire 100 enters the left atrium along the atrial septum puncture guidewire 100, the dilator 300, and the controllable bending sheath 500, and the dilator 300 and the atrial septum puncture guidewire 100 simultaneously exit from the controllable bending sheath 500.

[0054] As described above, atrial septal puncture was completed, and access to the left atrium from outside the body was established.

[0055] In this process, the control of the bending pattern of the controllable sheath 500 is a conventional technique known to those skilled in the art from existing techniques, and therefore will not be repeated here.

[0056] As is clear from the above two embodiments, the atrial septum puncture guide wire 100 of the present disclosure can pass through the lumen of the atrial septum puncture needle and the lumen of the dilator in an extended state, and even after the puncture needle body 1 punctures the atrial septum and enters the left atrium with the support of the puncture body 2 and the guide wire body 20, the curved outer side of the puncture member 10 carrying the puncture needle body can be directed toward the left atrial endocardium, the left atrial ear, or the pulmonary vein ostium. If a collision occurs during this process, the puncture needle body 1 will also be displaced toward the guide wire body 20 or toward the guide wire body 20, and the puncture needle body 1 will move away from the left atrial endocardium, the left atrial ear, and the pulmonary vein, greatly reducing the risk of puncturing or piercing the left atrial endocardium, the left atrial ear, and the pulmonary vein.

[0057] Features described and / or illustrated in this specification for one embodiment may be used in the same and similar manner in one or more other embodiments and / or may be combined with or used in place of features of other embodiments.

[0058] The above-mentioned embodiments illustrate and explain the basic principles and main features of the present invention, but the present invention is not limited to the above-mentioned embodiments, and any changes, modifications and design changes that do not contradict the spirit of the present invention shall fall within the scope of protection of the technical solutions of the present invention.

Claims

1. A puncture member having a puncture needle body including a puncture needle body, a puncture main body, and a connection part, which are integrally molded and connected in sequence, The puncture needle body has an elongated structure having a puncture tip, the puncture body has an arc structure with a central angle of 180° or more, and extends to a horizontal structure when loaded, and returns to the arc structure when unloaded; The distal end of the puncture needle body forms a support part having a tubular or columnar structure, The end of the support part contacts the tip of the puncture body, A puncture member having a puncture needle body, wherein a receding arc surface is formed between the distal end of the support part and the puncture body.

2. A puncture member having the puncture needle body according to claim 1, The puncture needle body is a puncture member having an arc-shaped cross section.

3. A puncture member having the puncture needle body according to claim 2, a first puncturing surface is formed by connecting a first puncturing plane surface and a first puncturing curved surface in order from the tip to the end of the puncturing needle body; or A puncturing member, wherein a second puncturing surface having a planar structure is formed from the tip to the end of the puncturing needle body.

4. A puncture member having the puncture needle body according to claim 1, A piercing member in which a developing member is fitted into the inner cavity of the support portion.

5. A puncture member having the puncture needle body according to any one of claims 1 to 4, A puncture member in which the projection of the tip of the puncture needle body onto the center line of the connection part is on an extension line of the connection part.

6. A puncture member having the puncture needle body according to any one of claims 1 to 4, A puncturing member, wherein the tip of the puncturing body extends to form a linear extension that contacts the distal end of the puncturing needle body.

7. A puncture member having the puncture needle body according to any one of claims 1 to 4, A puncturing member, wherein the distal end of the puncturing body extends to form a horizontal extension portion that connects with the connecting portion.

8. A puncture member having the puncture needle body according to any one of claims 1 to 4, The puncture member, wherein the connecting portion is a tubular structure or a columnar structure.

9. A puncture member having the puncture needle body according to any one of claims 1 to 4, A puncturing member having the puncturing needle body that forms a plane symmetrical structure.

10. A puncture member having the puncture needle body according to claim 6, A puncturing member, wherein when the tip of the puncturing body extends linearly to form a linear extension portion, the linear extension portion extends in a horizontal direction.

11. A puncture member having the puncture needle body according to claim 7, A puncture member in which, when the tip of the puncture body extends linearly to form a linear extension portion and the end of the puncture body extends to form a horizontal extension portion, an angle of 10° or more and 30° or less is formed between the linear extension line and the horizontal extension line.

12. A puncture member having the puncture needle body according to claim 11, A puncture member, wherein when an angle of 10° to 30° is formed between an extension line of the linear extension portion and an extension line of the horizontal extension portion, the angle is 15°.

13. The puncture member having the puncture needle body according to claim 1, The cross section of the puncture needle body is an arc-shaped structure; a first puncturing surface is formed by connecting a first puncturing plane surface and a first puncturing arc surface in order from the tip of the puncturing needle body to the end of the puncturing needle body; The tip of the puncture body forms a linear extension, a tip end of the linear extension portion contacts the receding arc surface, and an end end of the puncture body contacts the connecting portion; the connecting portion has a tubular structure, and a projection of the tip of the puncture needle body onto a center line of the connecting portion is on an extension line of the connecting portion; The puncture needle body has a tubular structure, A puncture member in which the outer diameter of the puncture needle body, the outer diameter of the puncture main body, and the outer diameter of the connecting portion are the same length, and the inner diameter of the puncture needle body, the inner diameter of the puncture main body, and the inner diameter of the connecting portion are the same length.

14. An atrial septum puncture guidewire comprising a puncture member having the puncture needle body according to any one of claims 1 to 13 and a guidewire body extending horizontally, wherein a connection portion of the puncture member having the puncture needle body is aligned with and fixedly connected to a tip of the guidewire body.

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