WO2023093296A1

WO2023093296A1 - Puncture member having puncture needle body and atrial septal puncture guide wire

Info

Publication number: WO2023093296A1
Application number: PCT/CN2022/122665
Authority: WO
Inventors: 冯骥; 龚杰; 马刚; 张聪
Original assignee: 心诺普医疗技术（北京）有限公司
Priority date: 2021-11-23
Filing date: 2022-09-29
Publication date: 2023-06-01
Also published as: CN114259283B; JP2023076794A; CN114259283A

Abstract

A puncture member (10) having a puncture needle body and an atrial septal puncture guide wire (100). The puncture member (10) 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 (1) is a long straight structure having a puncture tip; the puncture body (2) is an arc-shaped structure having a central angle greater than or equal to 180°, and the puncture body (2) can be stretched to form a horizontal structure when loaded, and can return to the arc-shaped structure when unloaded. According to the puncture member (10) having a puncture needle body and the atrial septal puncture guide wire (100), the puncture needle body (1) of the long straight structure and the puncture body (2) of the arc-shaped structure are provided, so that the atrial septum can be easily punctured with the support of the puncture needle body (1), and the risk of scratching or cutting the left endocardium, the left atrial appendage, and pulmonary veins can also be reduced.

Description

Puncture member with puncture needle body and atrial septal puncture guide wire

technical field

The present application relates to the technical field of interventional medical devices in the Department of Cardiology, and in particular to a puncture member with a puncture needle body and an atrial septal puncture guide wire for puncturing the atrial septum.

Background technique

Atrial septal puncture is the only way to enter the left heart system through the right heart outside the body during cardiac intervention. For example, mitral valve dilatation and radiofrequency ablation of atrial fibrillation require atrial septal puncture first. Puncture of the interatrial septum is the first step to a successful operation. Since the left side of the atrial septum faces the ostium of the pulmonary vein and the left endocardium, atrial septal puncture requires relatively high puncture force, puncture feel, and puncture accuracy.

The instruments currently used to complete the function of atrial septal puncture are mainly atrial septal puncture needles and atrial septal puncture guide wires. The puncture tip of the atrial septal puncture needle is relatively thick, and a large puncture force is required for puncture, and the tip of the atrial septal puncture needle faces the left endocardium or left atrial appendage, so there is a risk of mistakenly puncturing the left endocardium or left atrial appendage Higher, it is easy to puncture or puncture the left endocardium and left atrial appendage, requiring the operator to have higher surgical operation ability; in view of this, the atrial septal puncture needle does not have the surgical method to extend into the pulmonary vein. However, the puncture tip of the atrial septal puncture guide wire is thinner, and does not require a large puncture force during puncture. The operator feels weak when puncturing, and it is not easy to know whether the puncture guide wire has pierced the atrial septum, and there is also a greater risk of false puncture , and the needle tip at the head end is warped, the risk of scratching or scratching the left endocardium and left atrial appendage during puncture or entering the pulmonary vein is relatively high, and the risk of scratching and scratching the pulmonary vein is also high during the process of withdrawing from the pulmonary vein big.

At present, there is no solution to overcome the technical problems existing in the prior art.

Contents of the invention

In view of this, the present application provides a puncture member with a puncture needle body and an interatrial septal puncture guide wire, which can easily puncture the atrial septum with the support of the puncture needle body, and can reduce the risk of scratching or scratching the left side. Risk of endocardium, left atrial appendage and pulmonary veins.

According to one aspect of the present application, there is provided a puncture member with a puncture needle body, which includes an integrally formed and sequentially connected puncture needle body, a puncture body, and a connecting portion; the puncture needle body is a long straight structure with a puncture tip ; The puncture body is an arc-shaped structure with a central angle greater than or equal to 180°, and the puncture body can be stretched into a horizontal structure when loaded, and can return to an arc-shaped structure when unloaded.

According to another aspect of the present application, there is provided a transseptal puncture guide wire, which includes the aforementioned puncture member with a puncture needle body and a guide wire body extending horizontally, the puncture member with a puncture needle body The connecting part is matched and fixedly connected with the head end of the guide wire body.

The embodiment of the present application discloses that the puncture member with the puncture needle body and the interatrial septal puncture guide wire of the present application can not only be in the puncture needle body The interatrial septum can be pierced easily with support, while reducing the risk of scratching or tearing the left endocardium, left atrial appendage, and pulmonary veins.

Additional advantages, objectives, and features of the present application will be partially set forth in the following description, and will be partially apparent to those of ordinary skill in the art after studying the following, or can be known from the practice of the present application. The objectives and other advantages of the application may be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.

Those skilled in the art will appreciate that the purposes and advantages that can be achieved by the present application are not limited to the above specific description, and the above and other purposes that can be achieved by the present application will be more clearly understood from the following detailed description.

Description of drawings

The drawings described here are used to provide a further understanding of the application, constitute a part of the application, and do not limit the application. The components in the figures are not to scale but merely serve to illustrate the principles of the application. For ease of illustration and description of some parts of the present application, corresponding parts in the drawings may be exaggerated, ie, may be made larger relative to other components in the exemplary system actually manufactured in accordance with the present application. In the attached picture:

FIG. 1A is a schematic structural view of an embodiment of a puncture member with a puncture needle body of the present application;

FIG. 1B is a partial cross-sectional structural schematic diagram of FIG. 1A;

Figure 1C is a schematic cross-sectional view of A-A in Figure 1B;

Figure 1D is an enlarged schematic view of area B in Figure 1B;

FIG. 1E is a schematic structural view of an extended state of an embodiment of the puncture member of the present application;

Figure 2 is a schematic structural view of another embodiment of the puncture member of the present application;

Fig. 3A is a structural schematic diagram of another embodiment of the puncture member with a puncture needle body of the present application;

Figure 3B is an enlarged schematic view of region C in Figure 3A;

FIG. 4A is a schematic structural view of an embodiment of the interseptal puncture guide wire of the present application;

FIG. 4B is a schematic structural view of an embodiment of the interseptal puncture guidewire of the present application in a stretched state;

Figure 5 is a schematic diagram of the sheath and the dilator pushing the atrial septum into an umbrella shape in the right atrium;

Fig. 6A is a schematic diagram of a state in which an embodiment of the atrial septal puncture guidewire of the present application cooperates with the atrial septal puncture needle and the dilator, and the atrial septal puncture guidewire of the present application is located in the atrial septal puncture needle;

FIG. 6B is an enlarged schematic diagram of area D in FIG. 6A;

Fig. 7A is a schematic diagram of an embodiment of the atrial septal puncture guide wire of the present application cooperating with the atrial septal puncture needle and the dilator, and the atrial septal puncture guide wire of the present application extends out of the atrial septal puncture needle and is located in the dilator;

Figure 7B is an enlarged schematic view of the E region in Figure 7A;

Fig. 8A is a schematic diagram of a state in which an embodiment of the atrial septal puncture guidewire of the present application cooperates with the atrial septal puncture needle and the dilator, and the atrial septal puncture guidewire of the present application is fully extended out of the dilator;

Fig. 8B is an enlarged schematic diagram of area F in Fig. 8A;

FIG. 9 is a schematic view of an embodiment of the atrial septal puncture guidewire of the present application at the pulmonary vein ostium.

Reference signs:

1-puncture needle body, 11-first puncture surface, 111-first puncture plane, 112-first puncture arc surface, 12-second puncture surface, 13-support portion, 14-retraction arc surface;

2-puncture body, 21-straight line extension, 23-horizontal extension;

3-connection part; φ1-first included angle, φ2-second included angle, φ3-third included angle.

10 - puncture member with puncture needle body; 20 - guide wire body, 201 - position marking ring, 202 - radiopaque coil.

100-atrial septal puncture guide wire, 200-atrial septal puncture needle, 300-dilator, 400-fixed curved sheath, 500-controllable curved sheath.

Detailed ways

In order to make the purpose, technical solutions, and advantages of the embodiments of the present application clearer, the embodiments of the present application will be further described in detail below in conjunction with the accompanying drawings. Here, the exemplary embodiments of the application and their descriptions are used to explain the application, but not to limit the application.

Here, it should be noted that, in order to avoid obscuring the application due to unnecessary details, only the structures and/or processing steps that are closely related to the solution according to the application are shown in the drawings, and the steps related to the application are omitted. Other details that are not relevant to the application.

It should be emphasized that the term "comprises/comprises/has" when used herein refers to 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.

Here, it should also be noted that the orientation nouns such as "upper" and "lower" appearing in the content of this specification are relative to the position direction shown in the drawings; Refers to a direct connection, and can also indicate an indirect connection with an intermediate. A direct connection is a connection between two components without an intermediate component, and an indirect connection is a connection between two components through other components.

It should be noted here that, in this application, the head end refers to the end away from the operator (also the end close to the heart), and the tail end refers to the end close to the operator.

The present application proposes a puncture member with a puncture needle body, which includes an integrally formed and sequentially connected puncture needle body, a puncture body, and a connecting portion; the puncture needle body is a long straight structure with a puncture tip; the puncture body It is an arc-shaped structure with a central angle greater than or equal to 180°, and the puncture body can be stretched to form a horizontal structure when loaded, and can return to an arc-shaped structure when unloaded.

It can be seen from the above description that the puncture member with the puncture needle body of the present application can be made of a material that has high superelasticity and is suitable for interventional medical devices in various aspects, such as nickel-titanium alloy in the prior art, so that The puncture body can be stretched to form a horizontal structure when loaded, and can be restored when unloaded.

The puncture member with the puncture needle body of the present application not only provides sufficient supporting force for the puncture tip, but also has a better puncture force transmission effect, without using a large puncture force, and is convenient The puncture tip can puncture the interatrial septum; in addition, through the puncture body of the arc-shaped structure, the puncture member with the puncture needle body of the present application can be stretched into a horizontal structure, thereby smoothly passing through the mouth of the cooperating medical device (generally a dilator). The inner cavity reaches the position of the atrial septum, and can also slowly return to an arc-shaped structure after puncturing the atrial septum, so that the puncture body enters the left atrium from the right atrium with an arc-shaped outer wall surface, avoiding puncturing the left endocardium and left atrium by mistake. Atrial appendage; in the process of entering the pulmonary vein, the arc-shaped outer wall will not scratch or scratch the pulmonary vein, and the puncture needle body is always parallel to the extension line of the connecting part or towards the extension line of the connecting part, which can also avoid scratching Break or scratch the left endocardium and left atrial appendage; when withdrawing from the pulmonary vein, the puncture needle always points to the extension line parallel to or towards the extension line of the connection part, even if the puncture body touches the orifice of the pulmonary vein, It can only make the puncture needle body move along the extension line of the connection part or get closer to the extension line of the connection part, and it will stay away from the left endocardium and left atrial appendage, and will not scratch or scratch the left endocardium and the left atrial appendage; moreover, the puncture member with the puncture needle adopts an integrated structure, so that it also has sufficient stability during use. As can be seen from the above, the puncture member with the puncture needle of the present application can easily puncture the interatrial septum with the support of the puncture needle by arranging the long straight structure of the puncture needle and the arc-shaped puncture body. Can reduce the risk of scratching or tearing the left endocardium, left atrial appendage and pulmonary veins.

The structure of the puncture needle body 1 will be described below by taking Fig. 1A to Fig. 3B as an example.

If the puncture tip formed by the puncture needle body 1 is too thin, it is easy to cause the puncture tip to break during production, packaging, transportation and use, resulting in failure of the puncture tip, especially if the puncture tip breaks in the heart during use, it will cause very serious damage. accident; if the puncture tip formed by the puncture needle body 1 is too thick and blunt, a large puncture force must be applied to puncture the atrial septum when performing atrial septal puncture, which will not only increase the difficulty of the operation, but also increase the risk of the operation.

Referring to Fig. 1C, the projection of the tip of the puncture needle 1 on the horizontal plane forms a first included angle φ1 greater than or equal to 10° and less than or equal to 30°. Making the tip of the puncture needle body 1 have a certain width can effectively avoid the failure of the puncture tip on the one hand; The hole is beneficial to cooperate with the instrument (generally a dilator) to pass through the puncture hole more conveniently; on the other hand, the width of the puncture needle body 1 can still puncture the interatrial septum with a small puncture force. In the three preferred embodiments of the present application, the first included angle φ1 is selected to be 28°, but this does not affect the technical effect that can still be achieved when the first included angle φ1 is slightly greater than 30°. Therefore, when the first included angle φ1 is slightly smaller than 10° or slightly larger than 30°, it still falls within the protection scope of the present application.

Likewise, the projection of the tip of the puncture needle body 1 on the vertical plane can form a second included angle φ2 greater than or equal to 10° and less than or equal to 30°, see FIG. 1D and FIG. 3B . In the two embodiments shown in Fig. 1A to Fig. 1E and Fig. 2, from the tip of the puncture needle body 1 to the tail end of the puncture needle body 1, a first puncture plane 111 and a first puncture plane 111 are formed. The arc surface 112 is sequentially connected to form the first puncture surface 11, and the second included angle φ2 can be selected as 30°, so as to generate a larger puncture hole, which not only enables the matching instrument (generally a dilator) to pass through smoothly , and can pass through larger-diameter access instruments (such as sheath tubes), so the arcuate puncture surface 112 is used to ensure smooth progress during the rebound process of the atrial septum. In the embodiment shown in Figure 3A and Figure 3B, from the tip of the puncture needle body 1 to the tail end of the puncture needle body 1, a second puncture surface 12 of planar structure is formed, and the second included angle 15°, to ensure the sharpness of the puncture needle body 1, to ensure that the interatrial septum is punctured with as little puncture force as possible, and to reduce the difficulty of the operation.

Alternatively, the projection of the tip of the puncture needle body 1 on the horizontal plane forms a first included angle φ1 greater than or equal to 10° and less than or equal to 30°, and at the same time, the projection of the tip of the puncture needle body 1 on the vertical plane The projection forms a second included angle φ2 greater than or equal to 10° and less than or equal to 30°. At this time, the first puncture surface 11 or the second puncture surface 12 can be used to realize the second included angle φ2, so that the puncture needle body 1 When the puncture needle body 1 pierces the interatrial septum, the puncture feel is strong, that is, the operator can clearly feel that the puncture needle body 1 pierces the atrial septum to complete the puncture; After the tight umbrella-shaped interatrial septum (referring to Fig. 5) is punctured, it can also smoothly and quickly return to the original position (the initial position that is not tightened) along the first puncture surface 11 or the second puncture surface 12; Otherwise, the puncture force required by the puncture needle body 1 is still relatively small. These two embodiments have ensured that the puncture needle body 1 can not only complete interatrial septal puncture relatively easily, but also effectively avoid failure of the puncture tip.

In an optional embodiment, the projection of the head end of the puncture needle body 1 on the centerline of the connecting part 3 falls on the extension line of the connecting part 3 . In the existing puncture guide wire, the connecting section of the U-shaped puncture part is relatively long, and the projection of the puncture tip of the atrial septal puncture guide wire on the center line of the connecting part falls on the connecting part; when in use, the operator holds the proximal end of the body Pushing requires the operator to apply a large puncture force to complete the puncture; after the atrial septum is punctured, the puncture guide wire directly rushes into the left atrium due to the force of inertia, and there is a greater risk of scratching or tearing the left endocardium . Therefore, the puncture member with the puncture needle body of the present application shortens the length of the connecting part 3 to ensure a small puncture force to complete the atrial septal puncture, greatly reducing the risk of scratching or tearing the left endocardium.

The tail end of the puncture needle body 1 can further form a support part of a tubular structure or a columnar structure, and the tail end of the support part is connected to the head end of the puncture body 2, so as to increase the support of the puncture body 2 against the puncture body 2. The supporting force of the puncture needle body 1 described above is convenient for maintaining the stability of the puncture needle body 1 , and is also conducive to transmitting the puncture force to the puncture tip of the puncture needle body 1 . Considering the safety when the puncture needle body 1 is withdrawn from the opening of the head end of the matching instrument (generally an expansion tube) to the inner cavity of the matching instrument, it is preferably used between the tail end of the support part and the puncture body 2 A retraction arc surface is formed to realize a smooth transition during the retraction process and prevent the tail end of the support part from being hooked on the opening of the head end of the matching instrument. If the tail end of the puncture needle body 1 is formed with a support portion 13 of a tubular structure, a developing portion formed of a developing material can also be embedded in the inner cavity of the support portion 13, and the number of the puncture needle body 1 can be increased. The visualization under X-ray is beneficial for the operator to accurately judge the position of the puncture needle body 1 in the heart during use, thereby improving the safety of the operation. Referring to FIG. 1B and FIG. 1E in detail, the tail of the support portion 13 of the tubular structure forms a retreat arc 14 .

The structure of the puncture body 2 will be described below by taking FIGS. 1A to 3B as examples.

The puncture body 2 of the puncture member with the puncture needle body of the present application, in the initial state, presents an arc-shaped structure with a central angle greater than 180° as shown in Figure 1A and Figure 3A or an arc structure with a central angle equal to 180° arc structure. Taking an embodiment shown in Figure 1A as an example, when in use, the puncture body 2 is inserted into the lumen of a matching device (generally a dilator). When the inner wall is loaded, it stretches in a horizontal state approximately as shown in Figure 1E and passes through the inner cavity of the matching device. The puncture needle body 1 extends out of the opening of the head end of the matching device, punctures the interatrial septum, enters the left atrium, and punctures the body 2. As the puncture needle body 1 slowly enters the left atrium, it returns to an arc-shaped structure. When the curved outside of the puncture body 2 hits the left endocardium and/or the left atrial appendage (that is, the curved outside of the puncture body is resisted), the puncture tip of the puncture needle body 1 is in a direction parallel to the connecting portion 3 or toward Displacement occurs in the direction of the connecting part 3, even if it moves toward the direction in which the opening of the puncture body 2 is closed, it will stay away from the left endocardium during the whole process, greatly reducing the risk of stabbing or puncturing the left endocardium; the puncture body 2 continues Extend into the left atrium until the curved outside of the puncture body 2 penetrates into the pulmonary vein. When the curved outside of the puncture body 2 hits the inner wall of the pulmonary vein (that is, the curved outside of the puncture body is resisted), the puncture needle 1 is still along the The extension line of the connecting part 3 or the direction that makes the opening of the puncture body 2 move away from the left atrial appendage, which greatly reduces the risk of stabbing or puncturing the left atrial appendage; the puncture body 2 continues to extend into the pulmonary vein to complete the external access After the establishment of the left atrium access, withdraw from the pulmonary vein, if the curved outside of the puncture body 2 hits the inner wall of the pulmonary vein during this process (that is, the curved outside of the puncture body is resisted), the puncture needle 1 is still facing toward the puncture body. The opening of the 2 moves in the direction of retraction, without touching the intima of the pulmonary vein, and greatly reduces the risk of stabbing or puncturing the pulmonary vein. Therefore, the puncture member with a needle body of the present application adopts the puncture needle body and the puncture body, and when the curved outer side of the puncture body is resisted, the puncture needle tip will move along the The direction of the connecting part or the direction to make the opening of the puncture body move away from the left endocardium, left atrial appendage and pulmonary vein, greatly reducing the risk of stabbing or puncturing the left endocardium, left atrial appendage and pulmonary vein.

In a specific embodiment, the head end of the puncture body 2 is extended to form a linear extension section 21, and the linear extension section 21 is connected to the tail end of the puncture needle body 1; and/or, the puncture body 2 is extended to form a horizontal extension section 23, and the horizontal extension section 23 is connected to the connecting part 3, so as to realize the integrated structure of the puncture member with the puncture needle body of the present application and ensure the stability of its overall structure , Improve the safety of traveling in blood vessels and heart. For example, in a specific embodiment shown in FIG. 1A to FIG. 1E , the extension line of the linear extension section 21 and the extension line of the horizontal extension section 23 form an angle greater than or equal to 10° and less than or equal to 30°. ° of the third included angle φ3, referring to Fig. 1B and Fig. 1E, it can be known from the basic principle of plane geometry that the central angle of the puncture body 2 is the sum of the third included angle φ3 and 180°, that is, for the third included angle φ3 The included angle φ3 defines that the central angle of the puncture body 2 is greater than or equal to 190° and less than or equal to 220°. Preferably, the third included angle φ3 is 15°, so that the overall performance of the extended state and puncturing performance of the puncture body 2 is good.

As for the connecting part 3, it can be arranged as a tubular structure or a columnar structure, so as to facilitate the connection of a guide wire to form a puncture guide wire. In an optional embodiment, the puncture member with a puncture needle forms a plane symmetrical structure with the vertical plane as a symmetric plane, so that the puncture members with a puncture needle are located in the same plane, and the operator During use, the direction of the puncture tip of the puncture needle body 1 can be judged through the operating end, and the torque formed during use of the puncture member with the puncture needle body can be reduced, thereby improving the safety of operation. Preferably, 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 equal in length, and the inner diameter of the puncture needle body 1, the inner diameter of the puncture body 2, and the outer diameter of the puncture body 2 are preferably equal in length. The inner diameter of the connecting portion 3 is equal; and/or, the section of the puncture needle body 1 is arc-shaped, which facilitates the simplification of the manufacturing process steps.

In the specific embodiments shown in Figures 1A to 1E, the present application proposes a puncture member with a puncture needle body, which forms a plane symmetrical structure with the vertical plane as the plane of symmetry;

The section of the puncture needle body 1 is an arc-shaped structure; on the horizontal plane, the projection of the tip of the puncture needle body 1 forms an included angle of 28°; on the vertical plane, from the tip of the puncture needle body 1 to the The tail end of the above-mentioned puncture needle body 1 forms the first puncture surface 11 composed of the sequential connection of the first puncture plane 111 and the first puncture arc surface 112, and an included angle of 30° is formed between the first puncture plane 111 and the horizontal plane. The tail end of the puncture needle body 1 forms a support portion 13 of a tubular structure, and the tail end of the support portion 13 forms a retraction arc surface 14; the inner cavity of the support portion 13 is matched with a developing member embedded;

The head end of the puncture body 2 is extended to form a straight extension section 21, and an included angle of 15° is formed between the straight extension section 21 and the horizontal plane, and the head end of the straight extension section 21 and the retracted arc surface 14 connected; the tail end of the puncture body 2 is connected to the connecting part 3;

The connection part 3 is a tubular structure, and the projection of the head end of the puncture needle body 1 on the center line of the connection part 3 falls on the extension line of the connection part 3;

The outer diameter of the puncture needle body 1, the outer diameter of the puncture body 2 and the outer diameter of the connecting part 3 are equal in length, the inner diameter of the puncture needle body 1, the inner diameter of the puncture body 2 and the connecting portion The inner diameter of part 3 is equal in length.

In one embodiment, the present application also proposes an interatrial septal puncture guide wire, comprising the above-mentioned puncture member with a puncture needle body and a guide wire body extending horizontally, the connection of the puncture member with a puncture needle body The part is matched and fixedly connected with the head end of the guide wire body. Specifically, the connection part of the puncture member with the puncture needle is a tubular structure, the head end of the guide wire body is arranged in a columnar structure, and the head end of the guide wire body is matched and sleeved in the connection part. It is also possible that the connection part of the puncture member with the puncture needle body is a columnar structure, the head end of the guide wire body is arranged in a tubular structure, and the head end of the guide wire body is matched and sleeved outside the connection part.

Taking a specific embodiment of the atrial septal puncture guide wire proposed by the present application as shown in FIG. 4A and FIG. 4B as an example, the process in which the atrial septal puncture guide wire of the present application extends out of the dilator to puncture the atrial septum will be described. Wherein, the atrial septal puncture guide wire 100 includes the puncture member 10 with a puncture needle body and a guide wire body 20; the guide wire body 20 sequentially includes an integrally formed first section, tapered Connecting the segment and the second segment, the diameter of the second segment is smaller than the diameter of the first segment; and/or, at least one position marking ring 201 is provided at the tail end of the guide wire body 20, which is convenient for the operator to judge the position The position where the guide wire body 20 enters the matching device (generally a dilator), thereby assisting the operator to judge the specific position of the puncture needle body 1 in the matching device; and/or, the tail end of the guide wire body 20 is provided with The radiopaque coil 202 is used to improve the visualization under X-ray; and/or, the tail end of the guide wire body 20 is provided with a pointing plate consistent with the direction of the puncture needle body 1, and the operator passes the direction of the pointing plate The direction can determine the direction of the puncture needle body 1 relative to the guide wire body 20 . The puncture member with a puncture needle used is a specific embodiment of the puncture member with a puncture needle of the present application as shown in FIG. 1A to FIG. 1E .

Embodiment 1: The matching medical devices are a transseptal puncture needle 200 , a dilator 300 and a fixed curved sheath 400 .

In actual use, the dilator 300 is first sleeved in the fixed curved sheath 400 to form a dilator assembly; the dilator assembly enters the right atrium and pushes the interatrial septum into an approximate umbrella shape (for example, it can enter through the inferior vena cava, push to the superior vena cava, then slide down to the atrial septum, and push the dilator assembly to tighten the atrial septum into an umbrella shape), as shown in Figure 5.

The atrial septal puncture guide wire 100 of the present application is sleeved in the atrial septal puncture needle 200 to form a puncture needle assembly, the fixed curved sheath tube 400 and the dilator 300 are kept fixed, the puncture needle assembly is sleeved on the dilator 300, and pushed The puncture needle assembly, until the atrial septal puncture needle 200 abuts against the diameter change of the head end of the dilator 300, and the head end of the atrial septal puncture guide wire 100 is close to the head end of the atrial septal puncture needle 200, see Fig. 6A and Fig. 6B;

Continue to advance the interseptal puncture guide wire 100 of the present application until the puncture member 10 with the puncture needle passes through the head opening of the atrial septal puncture needle 200 and is close to the head opening of the dilator 300, ready for puncture, see FIG. 7A and Figure 7B;

Slowly advance the interseptal puncture guide wire 100, and protrude from the outlet of the head end of the dilator 300. As the atrial septal puncture guide wire 100 continues to advance, the puncture needle body 1 of the puncture member 10 with the puncture needle body slowly extends out. The head end of the dilator 300 exits, punctures the interatrial septum, and the interatrial septum rebounds to allow the dilator 300 to pass through the atrial septum; continue to advance the atrial septum puncture guide wire 100 until the puncture member 10 with the puncture needle body is completely stretched out of the dilator 300 and It gradually returns to an arc shape, as shown in Figure 8A and Figure 8B.

Continue to advance the puncture member 10 with the puncture needle body into the pulmonary vein ostium, fix the interseptal puncture guide wire 100, advance the dilator 300 and fix the curved sheath tube 400; 400 enters the left atrium, and the dilator 300 , the atrial septal puncture needle 200 and the atrial septal puncture guide wire 100 exit the fixed curved sheath 400 at the same time.

At this point, atrial septal puncture was completed, and access from the outside to the left atrium was established.

Embodiment 2: A dilator 300 and a controllable bending sheath 500 are matched with medical instruments.

The previous stage is the same as that of Embodiment 1. The dilator 300 is sheathed in the steerable bendable sheath 500 to form another dilator assembly; the other dilator assembly enters the right atrium and pushes the interatrial septum into an umbrella shape.

The interatrial septal puncture guide wire 100 is directly inserted into the dilator 300, and reaches the opening of the head end of the dilator 300, ready for puncture. Continue to advance the atrial septal puncture guide wire 100 to puncture the atrial septum, and the atrial septum rebounds to allow the dilator 300 to pass through the atrial septum; continue to advance the atrial septal puncture guide wire 100 until the puncture member 10 with the puncture needle body completely extends out of the dilator 300 And gradually restore the arc.

Continue to advance the puncture member 10 with the puncture needle body into the pulmonary vein ostium, fix the atrial septal puncture guide wire 100, advance the dilator 300 and the controllable bend sheath tube 500; The sheath 500 enters the left atrium, and the dilator 300 and the atrial septum puncture guide wire 100 exit the controllable bend sheath 500 at the same time.

During this process, the bending control of the controllable bending sheath 500 is a prior art, and those skilled in the art can know this content from the existing procedures, so it will not be repeated here.

It can be seen from the above two embodiments that the atrial septal puncture guide wire 100 of the present application can pass through the lumen of the atrial septal puncture needle and the lumen of the dilator in a stretched state, and the puncture needle body 1 is connected between the puncture body 2 and the guide wire body 20. After the interatrial septum is punctured into the left atrium under the support of the puncture needle, the curved outside of the puncture member 10 with the puncture needle body can also be directed towards the left endocardium, left atrial appendage or pulmonary vein ostium. The needle body 1 will also be displaced along the direction of the guide wire body 20 or toward the direction of the guide wire body 20, and the puncture needle body 1 will be far away from the left endocardium, left atrial appendage and pulmonary vein, greatly reducing the risk of stabbing or puncturing the left heart. Risk of intima, left atrial appendage, and pulmonary veins.

In this application, features described and/or exemplified for one embodiment may be used in the same or similar manner in one or more other embodiments, and/or be combined with or replace other features of other embodiments Features of the implementation.

The above-listed embodiments have shown and described the basic principles and main features of the present application, but the present application is not limited by the above-mentioned embodiments, and those skilled in the art can make modifications, Equivalent changes and modifications shall fall within the protection scope of the technical solution of the present application.

Claims

A puncture member with a puncture needle, characterized in that the puncture member with a puncture needle includes a puncture needle, a puncture body and a connecting portion that are integrally formed and sequentially connected; the puncture needle is a puncture tip with a puncture tip Long straight structure; from the tip of the puncture needle body to the tail end of the puncture needle body, a first puncture surface consisting of a first puncture plane and a first puncture arc surface is formed sequentially, or a second puncture surface of a planar structure is formed. The piercing surface: the piercing body is an arc-shaped structure with a central angle greater than or equal to 180°, and the piercing body can be stretched to form a horizontal structure when loaded, and can return to an arc-shaped structure when unloaded.
The puncture member with a puncture needle according to claim 1, wherein the projection of the tip of the puncture needle on the horizontal plane forms a first included angle greater than or equal to 10° and less than or equal to 30°;

And/or, the projection of the tip of the puncture needle on the vertical plane forms a second included angle greater than or equal to 10° and less than or equal to 30°;

And/or, the cross-section of the puncture needle is arc-shaped.
The puncture member with a puncture needle according to claim 2, wherein when the projection of the tip of the puncture needle on the horizontal plane forms a first included angle greater than or equal to 10° and less than or equal to 30° , the first included angle is 28°;

and / or,

When the projection of the tip of the puncture needle on the vertical plane forms a second included angle greater than or equal to 10° and less than or equal to 30°, from the tip of the puncture needle to the tail of the puncture needle end, forming the first puncture surface composed of the sequential connection of the first puncture plane and the first puncture arc surface, the second included angle is 30°; or, when the projection of the tip of the puncture needle on the vertical plane When forming a second included angle greater than or equal to 10° and less than or equal to 30°, a second puncture surface of a planar structure is formed from the tip of the puncture needle to the tail end of the puncture needle, and the second The included angle is 15°.
The puncture member with a puncture needle according to claim 1, wherein the tail end of the puncture needle forms a support portion of a tubular structure or a column structure, and the tail end of the support portion is connected to the puncture body. The ends meet.
The puncture member with a puncture needle according to claim 4, wherein when the tail end of the puncture needle forms a column-shaped support, there is a gap between the tail end of the support and the puncture body. Form a retracement arc;

Alternatively, when the tail end of the puncture needle forms a support portion of a tubular structure, a retreat arc surface is formed between the tail end of the support portion and the puncture body, and/or, the inner cavity of the support portion Matching embedded development parts.
The puncture member with a puncture needle according to any one of claims 1-5, wherein the projection of the head end of the puncture needle on the center line of the connection part falls on the connection part on the extension line;

And/or, the head end of the puncture body is extended to form a straight extension section, and the straight extension section is connected to the tail end of the puncture needle body;

And/or, the tail end of the puncture body is extended to form a horizontal extension section, and the horizontal extension section is connected to the connecting part;

And/or, the connecting part is a tubular structure or a columnar structure;

And/or, the piercing member with the piercing needle forms a plane symmetrical structure with the vertical plane as the plane of symmetry.
The puncture member with a puncture needle according to claim 6, wherein when the head end of the puncture body is extended to form a linear extension, the linear extension extends along the horizontal direction;

Or, when the head end of the puncture body is extended to form a linear extension, and the tail end of the puncture body is extended to form a horizontal extension, the distance between the extension of the linear extension and the extension of the horizontal extension is A third included angle is formed that is greater than or equal to 10° and less than or equal to 30°.
The puncture member with a puncture needle according to claim 7, characterized in that, when the extension line of the linear extension section and the extension line of the horizontal extension section form an angle greater than or equal to 10° and less than or equal to 30° °, the third included angle is 15°.
The puncture member with a puncture needle according to claim 1, wherein the puncture member with a puncture needle forms a plane symmetrical structure with the vertical plane as the plane of symmetry;

The section of the puncture needle body is an arc-shaped structure; on the horizontal plane, the projection of the tip of the puncture needle body forms an included angle of 28°; on the vertical plane, from the tip of the puncture needle body to the puncture needle The tail end of the body forms the first puncture surface formed by the sequential connection of the first puncture plane and the first puncture arc surface, and an angle of 30° is formed between the first puncture plane and the horizontal plane; the tail of the puncture needle body The end forms a support portion of the tubular structure, and the tail end of the support portion forms a retracted arc surface;

The head end of the puncture body is extended to form a straight extension section, and an included angle of 15° is formed between the straight extension section and the horizontal plane, and the head end of the straight extension section is in contact with the withdrawal arc surface; The tail end of the puncture body is connected to the connecting part;

The connection part is a tubular structure, and the projection of the head end of the puncture needle on the center line of the connection part falls on the extension line of the connection part;

The outer diameter of the puncture needle body, the outer diameter of the puncture body and the outer diameter of the connecting part are equal in length, the inner diameter of the puncture needle body, the inner diameter of the puncture body and the inner diameter of the connecting part are equal in length .
An atrial septal puncture guide wire, characterized in that the atrial septal puncture guide wire comprises a puncture member with a puncture needle body and a guide wire body extending horizontally according to one of claims 1 to 9, The connection part of the puncture member with the puncture needle is matched and fixedly connected with the head end of the guide wire body.