JP3237114U - Guide wire for new atrial septal puncture - Google Patents

Abstract

PROBLEM TO BE SOLVED: To reduce the risk of penetrating and damaging the left atrial appendage and the left intima when piercing the atrioventricular septum into the left atrium and pushing it to the pulmonary vein, and when pulling back from the pulmonary vein, the lung. Provided is a guide wire for atrial septal puncture that can also reduce the risk of damaging the inner wall of the vein. SOLUTION: The guide wire for puncturing the interatrial septum has a main body 1 having a horizontally extending elongated structure and a flat wire structure having a C shape, and can extend horizontally at the time of loading, and it can extend horizontally at the time of unloading. A puncture member 4 that can be restored into a C shape is provided, and one end of the puncture member 4 is fixedly connected to the distal end of the main body, and the other end extends to form the tip of the puncture needle. In the present invention, a C-shaped puncture member 4 is provided at the distal end of the main body having an elongated structure. [Selection diagram] Fig. 1

Description

The present invention relates to the technical field of a cardiovascular intervention treatment device, and particularly to a novel guide wire for puncturing an atrial septum for puncturing an atrial septum.

Atrial septal puncture is essential for cardiac intervention treatment to enter the left heart system from outside the body via the right atrium. Septal puncture is required. Atrial septal puncture is the first step to successful surgery. In atrial septal puncture, the left side of the atrial septum faces the pulmonary venous ostium and the left endocardium, which increases the demand for puncture force, puncture operability, and puncture accuracy.

The guide wire for atrial septal puncture is suitable for atrial septal puncture in various cardiovascular intervention treatments, and various transvascular intervention treatment instruments are used from outside the body, through the right atrium, through the foramen ovale, and in the left atrium. You can guide them into the position.

The conventional guide wire for atrial septal puncture includes a main body and a U-shaped puncture portion having a flat wire structure provided at the distal end of the main body, and the puncture portion is U-shaped so as to easily pass through the dilator. The tip of the mold puncture portion extends along the axial direction of the main body and warps toward the direction away from the main body. Therefore, after the tip of the U-shaped puncture site enters the left atrium through the atrial septum, there is a high risk of penetrating the left atrial appendage and the left endocardium and injuring it, and the puncture site is pushed into the pulmonary vein and then pulled back. In some cases, there is also an increased risk of damaging the lining of the pulmonary veins.

Currently, there is no technical means to solve this technical problem.

Therefore, the present invention reduces the risk of penetrating and injuring the left atrial appendage and the left intima when piercing the atrioventricular septum into the left atrium and pushing it to the pulmonary vein, and when pulling it back from the pulmonary vein. To provide a novel guide wire for atrial septal puncture that can also reduce the risk of damaging the inner wall of the pulmonary vein.

According to one aspect of the present invention, the main body has an elongated structure extending horizontally and a flat wire structure having a C shape, and can be extended horizontally at the time of loading, and is restored to the C shape by itself at the time of unloading. With a possible puncture member, the puncture member provides a novel atrial septal puncture guide wire with one end fixedly connected to the distal end of the body and the other end extending to form the tip of the puncture needle. ..

In some embodiments of the present invention, the puncture member comprises an arcuate portion with a central angle greater than 180 °, with a horizontal extension at one end of the arcuate portion fixedly connected to the distal end of the body, forming a circle. The linear extending portion at the other end of the arc-shaped portion extends and contacts the tip of the puncture needle.

In some embodiments of the present invention, a first connecting tube is provided at the horizontally extending portion of the arcuate portion, and a first connecting column that can be fitted in the first connecting tube is provided at the distal end of the main body. , The arcuate portion and the main body are fixedly connected via the first connection tube and the first connection pillar, or a second connection tube is provided at the distal end of the main body, and the arcuate portion is horizontally extended. A second connecting column that can be fitted in the second connecting tube is provided in the portion, and the main body and the arcuate portion are fixedly connected via the second connecting tube and the second connecting column.

In some embodiments of the present invention, the extension line of the straight extending portion of the arcuate portion and the center line of the main body form an angle of 20 ° or more and 40 ° or less, and / or the main body of the piercing needle tip portion. The projection at the center line overlaps with the main body and / or the symmetry line of the piercing member and the center line of the main body are located on the same plane, and this plane is the symmetry plane of the piercing member.

In some embodiments of the present invention, the tip of the puncture needle extends toward the main body and warps in the direction opposite to the main body, and / or the tip of the puncture needle tip is 10 ° or more and 30 °. Make the following corners.

In some embodiments of the present invention, the body sequentially comprises an integrally molded first part, tapered connection part and second part from the proximal end to the distal end, the diameter of the second part being the first part. And / or at least one position marker is provided at the proximal end of the body and / or a radiodensity coil is provided at the distal end of the body.

In the embodiment of the present invention, by providing a C-shaped puncture member at the distal end of the main body of the elongated structure, the left atrium is pierced into the left atrium and then pushed to the pulmonary vein. It can reduce the risk of penetrating and damaging the ears and left atrium, as well as the risk of damaging the inner wall of the pulmonary vein when pulled back from the pulmonary vein.

Additional advantages, objectives and features of the present invention will be partially described in the following description and will be partially apparent to those skilled in the art from the following description or may be understood from the practice of the present invention. The object and other advantages of the present invention can be achieved by the configuration specifically described in the specification, the claims for utility model registration and the drawings.

For those skilled in the art, the objectives and advantages achieved by the present invention are not limited to the above specific description, and the above and other objectives achieved by the present invention will be described in detail below. It will be clearly understood.

The drawings described herein are for the purpose of further understanding the present invention and constitute a part of the present invention, but do not limit the present invention. The components in the drawings are not drawn to scale, but merely to show the principles of the present invention. Corresponding parts in the drawings are enlarged to facilitate illustration and description of some parts of the invention, i.e., larger than the other components of the exemplary system actually manufactured in accordance with the present invention. there is a possibility. In the drawing
It is a structural schematic diagram of the novel guide wire for atrial septal puncture of the present invention. It is another structural schematic diagram of the novel guide wire for interatrial septal puncture of the present invention. FIG. 2 is a cross-sectional view taken along the line AA in FIG. It is a figure which shows the state which the novel guide wire for the interatrial septum of the present invention punctured the interatrial septum in combination with the dilator and the sheath.

Hereinafter, in order to further clarify the purpose, technical means, and advantages of the embodiments of the present invention, the embodiments of the present invention will be described in detail with reference to the drawings. Here, the exemplary embodiment of the present invention and its description are for the purpose of explaining the present invention, but are not limited to the present invention.

Here, in order to avoid obscuring the present invention with unnecessary details, the drawings show only the structures and / or processing steps closely related to the technical means according to the present invention. Other details that are not very relevant to the device are omitted.

It should be noted that terms such as "provide / include / have", as used herein, mean the presence of a feature, element, step or component, but one or more other features, elements. It does not preclude the existence or addition of steps or components.

Further, the terms indicating the orientation such as "upper part" and "lower part" described in the present specification correspond to the positional direction shown in the drawings. Unless otherwise stated, the term "connection" can also mean, as used herein, not only a direct connection, but also an indirect connection via an inclusion. A direct connection means that the two components are connected without intervening components, and an indirect connection means that the two components are connected via other components. Is to be done.

Here, in the present invention, the distal end refers to the end far from the operator (the end close to the heart), and the proximal end refers to the end close to the operator.

As shown in FIGS. 1 to 3, one embodiment of the novel guide wire for puncturing the interatrial septum of the present invention includes a main body 1 having a horizontally extending elongated structure and a C-shape for puncturing the interatrial septum. It has a flat wire structure that has a shape, and is equipped with a puncture member 4 that can extend horizontally when loaded and can be restored to a C shape by itself when unloading. The puncture member 4 has one end distal to the main body 1. It is fixedly connected to the end, and the other end extends to form the puncture needle tip portion 42.

The main body 1 of the novel guide wire for interatrial septal puncture of the present invention is manufactured by using a highly flexible metal wire such as a nickel-titanium alloy, and the elongated structure means that the main body 1 has a large slenderness ratio. Although it refers to a rod structure, since the main body 1 may be an equal-diameter rod or a different-diameter rod, the slenderness ratio of the elongated structure of the main body 1 is not specifically defined here.

The puncture member 4 of the novel guide wire for puncturing the interatrial septum of the present invention can also be manufactured by using a nickel-titanium alloy. The flat wire structure means that the cross section of the puncture member 4 is flat. The flat wire structure of the puncture member 4 can be in an almost horizontal extending state under the action of an external force when it is in the original state of forming a C shape, and when it is in an almost horizontal extending state. In addition, when the action of the external force is gradually lost, it can be gradually restored to the original C shape. The entire puncture member 4 has an integrally molded structure and has higher safety when inserted into the heart.

At the time of use, the novel guide wire for atrial septal puncture of the present invention is inserted into the lumen of the atrial septal puncture needle (with or without the needle tip), and the puncture member 4 at this time is the atrial septal puncture needle. It is in an almost horizontal extension state under the action of the external force of the inner wall of the interatrial septum, and the interatrial septal puncture needle is inserted into the rumen of the dilator. When piercing the atrial septum, a new guide wire for puncturing the atrial septum protrudes from the dilator, pierces the atrial septum into the left atrium, and is exposed from the dilator of the new guide wire for puncturing the atrial septum. As the length becomes longer, the external force action on the inner wall of the atrial septal puncture needle is lost, and the puncture member 4 is gradually restored to the original C-shaped state. When the C-shaped puncture member 4 hits the left endocardium when the new atrial septal puncture guide wire is continuously pushed so as to enter the pulmonary vein through the left cardiac ear and the left endocardium, the tip of the puncture needle Since the portion 42 extends toward the main body 1, the risk of penetrating and damaging the left cardiac ear and the left endocardium is reduced. After the dilator and sheath smoothly enter the left atrium, a new guide wire for atrial septal puncture is pulled back from the pulmonary vein, the puncture needle tip 42 is close to the main body 1, and the puncture member 4 forms a C shape. Therefore, when pulling back, the tip portion 42 of the puncture needle does not easily or almost does not hit the inner wall of the pulmonary vein, thus reducing the risk of damaging the inner wall of the pulmonary vein. In comparison, in the U-shaped puncture site of the prior art, when entering the pulmonary vein, the tip of the U-shaped puncture site penetrates the left atrial appendage and the left intima and is easily damaged, and when pulled back from the pulmonary vein, the U-shaped puncture site is easily damaged. The tip of the U-shaped puncture site tends to damage the inner wall of the pulmonary vein.

As a result, the novel guide wire for atrioventricular puncture of the present invention pierces the atrioventricular septum and enters the left atrium by providing a C-shaped puncture member 4 at the distal end of the main body 1 having an elongated structure. It is possible to reduce the risk of penetrating and damaging the left cardiac ear and the left intima when pushing to the pulmonary vein and after the pulmonary vein, and also to reduce the risk of damaging the inner wall of the pulmonary vein when pulling back from the pulmonary vein.

In one specific embodiment shown in FIG. 2, the puncture member 4 includes an arcuate portion 41 having a central angle larger than 180 °, and a horizontally extending portion 411 at one end of the arcuate portion 41 is distal to the main body 1. It is fixedly connected to the end, and the linear extending portion 412 at the other end of the arcuate portion 41 extends and comes into contact with the tip portion 42 of the puncture needle. That is, the puncture member 4 includes an integrally molded arcuate portion 41 having a central angle larger than 180 ° and a puncture needle tip portion 42. Since the arcuate portion 41 having a central angle larger than 180 ° and the linear extending portion 412 thereof allow the puncture needle tip portion 42 to be fitted toward the main body 1, the puncture needle tip portion 42 pierces the atrial septum. The risk of piercing and damaging the left atrial appendage or the left intima is greatly reduced after entering the left atrium and when pushing to the pulmonary vein, and the tip of the puncture needle when the puncture member 4 is pulled back from the pulmonary vein. The risk of 42 damaging the inner wall of the pulmonary vein can also be reduced.

The arcuate portion 41 is fixedly connected to the main body 1, for example, the first connection tube 413 is provided in the horizontally extending portion of the arcuate portion 41, and the arcuate portion 41 is fixedly connected to the main body 1 in the first connection tube 413 at the distal end. A first connecting column that can be fitted is provided, and the arcuate portion 41 and the main body 1 are fixedly connected (for example, may be crimped or bonded) via the first connecting tube 413 and the first connecting column. Alternatively, a second connecting tube is provided at the distal end of the main body 1, and a second connecting column that can be fitted in the second connecting tube is provided at the horizontally extending portion 411 of the arcuate portion 41. The main body 1 and the arcuate portion 41 may be fixedly connected (for example, may be crimped or bonded) via a second connecting tube and a second connecting column. When specifically carried out, it is common to use a relatively stable fixed connection method such as crimping or bonding, which can improve the connection stability between the main body 1 and the arcuate portion 41, and also. By polishing the connecting part, the contact between the connecting part and the atrial septum becomes smooth.

In a preferred embodiment, the extension line of the straight extending portion 412 of the arcuate portion 41 and the center line of the main body 1 form an angle of 20 ° or more and 40 ° or less, and the central angle of the arcuate portion 41 is formed by the principle of similarity triangle. Can be secured at 200 ° or more and 220 ° or less, satisfying that the puncture needle tip 42 faces the main body 1, and consumes fatigue life when switching between the extended state and the original state of the puncture member 4. It can be suppressed and / or the projection at the center line of the body 1 of the puncture needle tip 42 overlaps with the body 1 and / or the symmetric line of the piercing member 4 and the center line of the body 1 are on the same plane. This plane is the plane of symmetry of the puncture member 4.

The projection on the center line of the main body 1 of the puncture needle tip 42 overlaps with the main body 1 so that the length of the horizontal extending portion 411 is not too long. During use, the operator holds the proximal end of the body 1 and pushes it toward the distal end, and the puncture needle tip 42 pierces the atrial septum under the action of propulsive force to form a puncture force. Since the puncture member 4 has a flat wire structure and is highly flexible, if the length of the horizontally extending portion 411 is too long, the puncture needle tip 42 has sufficient puncture force to puncture the atrial septum. Great momentum needs to be added. However, the large propulsion force means that after the puncture needle tip 42 pierces the atrial septum, the puncture member 4 quickly enters the left atrium due to the disappearance of the resistance of the atrial septum, and the left atrium of the puncture member 4 It is too long to enter, increasing the risk of penetrating the left atrial appendage and the left intima and injuring or damaging it, as well as increasing the difficulty of surgery. Therefore, in the novel guide wire for atrial septal puncture of the present invention, the projection of the puncture needle tip portion 42 at the axis of the main body 1 overlaps with the main body 1 by shortening the length of the horizontal extending portion 411. With this configuration, the puncture force is easily transmitted from the proximal end of the main body 1 to the puncture needle tip portion 42, and the operator can perform puncture without using a large puncture force. A low puncture force not only facilitates puncture, but also allows the puncture member 4 to slowly enter the left atrium through the interatrial septum, increasing the risk of penetrating and damaging the left atrial appendage and the left endocardium. Can be reduced.

The symmetric line of the puncture member 4 and the center line of the main body 1 are located on the same plane so that the operator can easily determine the direction of the puncture needle tip portion 42, and when the main body 1 is pushed forward. It is possible to reduce the torque generated in the main body 1 and the puncture member 4 to prevent a series of problems such as the puncture direction cannot be specified by the torque.

When puncturing the atrial septum, the puncture needle tip 42 protrudes from the atrial septal puncture needle and advances at the distal end of the dilator until it protrudes from the dilator and punctures the atrial septum. The puncture needle tip 42 extends toward the main body 1 and opposes the main body 1 so that the puncture needle tip 42 does not damage the inner wall of the dilator and generate debris and cause surgical complications such as thrombus. By warping in the direction, it is possible to prevent the tip portion 42 of the puncture needle from coming into contact with the inner wall of the dilator when advancing in the dilator. Further, the tip portion 42 of the puncture needle forms an angle of 10 ° or more and 30 ° or less. If the angle formed by the tip of the puncture needle 42 is too small, the tip of the puncture needle is difficult to mold, and is easily damaged or broken during assembly, transportation, and use, the tip loses its function, and operability is poor during puncture. It is difficult to develop, and it is disadvantageous for the operator to judge the position and state of the tip of the puncture needle. If the angle formed by the tip of the puncture needle 42 is too large, the tip of the puncture needle is too dull during puncture, making it difficult to puncture the atrial septum.

In a practical embodiment, the main body 1 is sequentially provided with an integrally molded first part, a tapered connection part and a second part from the proximal end to the distal end, and the diameter of the second part is the first part. Since the diameter is smaller than the diameter, the transmission of the puncture force in the main body 1 can be ensured, and the fixed connection between the distal end of the main body 1 and the arcuate portion 41 can be smoothly performed. At least one position marker 2 may be provided at the proximal end of the main body 1, and the operator can use the position marker 2 to move a set product such as an atrial septal puncture needle or a dilator of the puncture needle tip 42 to a distance. You can check the length exposed from the opening at the end of the position. As shown in FIG. 1, two position markers 2 are used. Further, the radiation opaque coil 3 may be provided at the distal end of the main body 1, and the position of the distal end of the main body 1 can be clearly indicated under X-rays, so that the operator can clearly indicate the position of the distal end of the main body 1. Can accurately determine its position in the heart. As an installation method, for example, the radiation opaque coil 3 may be wound tightly around the distal end of the main body 1.

Hereinafter, the process of using the novel guide wire for interatrial septal puncture of the present invention will be briefly described by taking a specific embodiment shown in FIG. 4 as an example.

Taking the example of atrial septal puncture that enters the human body from the crotch vein, the main instruments that need to be used are a guide wire for guidance, a new guide wire for puncturing the atrial septum, and a needle for puncturing the atrial septum 20 (needle tip). The illustrated atrial septal puncture needle has a needle tip), the dilator 30, and the sheath 40 (other sheaths other than the flexible sheath).

A route from outside the body to the crotch vein was established, a guide wire for guidance was inserted into the superior septum by this route, and the sheath 40 and the dilator 30 fitted to the lumen of the sheath 40 were used using the guide wire for guidance. Pull back the guide wire for guidance, gently pull back the sheath 40 and dilator 30 to the oval foramen, and push the sheath 40 and dilator 30 until the atrial septum is expanded in a substantially umbrella shape. , A new interatrial septal puncture guide wire 10 is inserted into the atrial septal puncture needle 20, and a new atrial septal puncture guide wire 10 is inserted inside along the dilator 30. Is pushed until the distal end of the atrial septal puncture needle 20 reaches the distal end of the dilator 30 but does not protrude from the opening of the distal end of the dilator 30, at which time the position marker 2 and the atrial septal puncture needle. The distance between the pointers of 20 ensures that the tip of the new atrial septal puncture guide wire 10 is not exposed through the opening at the distal end of the atrial septal puncture needle 20.

At the start of puncture, the new atrial septal puncture guide wire 10 is pushed forward, and the distance between the position marker 2 and the opening at the proximal end of the dilator 30 causes the new atrial septal puncture guide wire 10 to be distal to the dilator 30. After confirming that it protruded from the opening at the end and puncturing the atrial septum, slowly push the new guide wire 10 for puncturing the atrial septum until the entire puncturing member 4 enters the left atrium, as shown in FIG. , The puncture member 4 is restored from the extended state to the original state (C-shaped), and the atrial septal puncture needle 20 is pushed along the new guide wire 10 for atrial septal puncture into the left atrium. , The bearing force of the atrial septal puncture needle 20 pushes the dilator 30 into the left atrium, and the sheath 40 and the dilator 30 remain stationary with the atrial septal puncture needle 20 and the new atrial septal puncture guide wire 10. Is pushed until the opening at the distal end of the sheath 40 enters the left atrium, the new guide wire for atrial septal puncture is retracted into the atrial septal puncture needle 20, and the atrial septal puncture needle 20 is dilator 30. It is retracted inward and the new guide wire 10 for atrial septal puncture, the atrial septal puncture needle 20 and the dilator 30 are synchronously pulled back from the sheath 40.

This establishes an extracorporeal route to the left atrium and completes atrial septal puncture.

As can be seen from the above-described embodiment, when performing the atrial septal puncture, the length through which the operator passes through the atrial septum of the puncture member 4 is clarified even if the radiation opaque coil 3 is developed. Since the operator's operation end is located at the proximal end of the main body 1 and the puncture operation of the interatrial septum is performed by the puncture member 4 located at the distal end of the main body 1, the operator puts it on the main body 1. The puncture force cannot be grasped. When the outer wall surface of the arcuate portion 41 (that is, the outer wall surface of the C-shaped portion) faces the left atrial appendage or the left endocardium after the puncture member 4 punctures the atrial septum, and the puncture force applied by the operator is large. In addition, when the outer wall surface of the arcuate portion 41 hits the left endocardium, the puncture needle tip portion 42 moves along the distal end of the main body 1 and the direction toward the axial center of the main body 1, and the arcuate portion 41 Further fits and largely prevents the puncture needle tip 42 from penetrating and injuring the left atrial appendage or the left endocardium, i.e., significantly reducing the risk of penetrating and injuring the left atrial appendage and the left endocardium. Similarly, after the puncture member 4 enters the pulmonary vein, the outer wall surface of the puncture member 4 faces the inner wall of the pulmonary vein, so that the risk of damaging the inner wall of the pulmonary vein can be significantly reduced. When the novel guide wire for atrial septal puncture of the present invention is pulled back from the pulmonary vein, the tip of the piercing needle 42 is close to the main body 1, and the inner diameter of the pulmonary vein that passes when pulling back is slightly larger, so that the inner wall of the pulmonary vein is slightly larger. It can be almost prevented from damaging the pulmonary veins, and the risk of damaging the inner wall of the pulmonary vein can be significantly reduced.

In the present invention, the features described and / or exemplified with respect to one embodiment can be used in the same or similar manner in one or more other embodiments, and / or features of other embodiments. Can be combined with, or substituted with features of other embodiments.

The above-mentioned examples have been described by showing the basic principles and main features of the present invention, but the present invention is not limited to the above-mentioned examples, and those skilled in the art do not perform creative labor. Any modifications, equivalent changes and modifications made to the present invention on the premise should be included within the scope of protection of the technical means of the present invention.

1: Main body 2: Position marker 3: Radiation opaque coil 4: Puncture member 41: Arc-shaped part 411: Horizontal extension part 412: Straight extension part 413: First connection tube 42: Puncture needle tip part 10: New Guide wire for atrial septal puncture 20: Atrial septal puncture needle 30: Dilator 40: Sheath

Claims (6)

It has a main body that extends horizontally and a flat wire structure that forms a C shape, and also has a puncture member that can extend horizontally when loaded and can be restored to a C shape by itself when unloading.
The puncture member is a guide wire for atrial septal puncture, characterized in that one end is fixedly connected to the distal end of the main body and the other end extends to form a puncture needle tip. The puncture member has an arcuate portion having a central angle of more than 180 °, and a horizontally extending portion at one end of the arcuate portion is fixedly connected to the distal end of the main body, and the other end of the arcuate portion is fixedly connected. The guide wire for atrial septal puncture according to claim 1, wherein the linear extending portion extends and comes into contact with the tip portion of the puncture needle. A first connecting tube is provided in the horizontally extending portion of the arc-shaped portion, and a first connecting column that can be fitted in the first connecting tube is provided at the distal end of the main body, and the arc-shaped portion and the said. The main body is fixedly connected via the first connecting tube and the first connecting column, or a second connecting tube is provided at the distal end of the main body and is provided on a horizontally extending portion of the arcuate portion. A second connecting column that can be fitted is provided in the second connecting tube, and the main body and the arcuate portion are fixedly connected via the second connecting tube and the second connecting column. The guide wire for puncturing the interatrial septum according to claim 2. The extension line of the straight extending portion of the arcuate portion and the center line of the main body form an angle of 20 ° or more and 40 ° or less, and / or.
The projection of the tip of the puncture needle at the center line of the main body overlaps with the main body and / or
The atrial septal puncture according to claim 2, wherein the symmetry line of the puncture member and the center line of the main body are located on the same plane, and this plane is the symmetry plane of the puncture member. Guide wire. The tip of the puncture needle extends toward the main body and warps up in the direction opposite to the main body, and / or the tip of the tip of the puncture needle forms an angle of 10 ° or more and 30 ° or less. The guide wire for puncturing the interatrial septum according to claim 1. From the proximal end to the distal end, the body comprises an integrally molded first part, a tapered connection part and a second part, the diameter of the second part being less than the diameter of the first part, and / Or, claim 1-5, characterized in that at least one position marker is provided at the proximal end of the body and / or a radiodensity coil is provided at the distal end of the body. The guide wire for puncturing the interatrial septum according to any one of the following items.

Images