阅读说明：本技术 用于穿刺房间隔缺损补片的穿刺装置 (Puncturing device for puncturing atrial septal defect patch ) 是由 刘俊 韩博阳 龚杰 于 2021-08-02 设计创作，主要内容包括：本申请提供一种用于穿刺房间隔缺损补片的穿刺装置,所述穿刺装置包括杆状结构的本体和固定设置于所述本体的远端的穿刺构件；所述穿刺构件为具有刃状边缘、且横截面为弧形的片状结构,所述片状结构能收拢呈筒状结构,该筒状结构的轴心与所述本体的轴心平行。本申请实施例的用于穿刺房间隔缺损补片的穿刺装置,能够完成房间隔缺损补片的房间隔穿刺,使房间隔缺损外科术后患者在不进行开胸术式的情况下,建立由体外到达左心房的微创介入治疗通路；术式所形成的创口较小,对患者造成的伤害较小,患者较容易恢复。(The application provides a puncture device for puncturing an atrial septal defect patch, which comprises a body of a rod-shaped structure and a puncture member fixedly arranged at the distal end of the body; the puncture component is a sheet structure which is provided with a blade-shaped edge and has an arc-shaped cross section, the sheet structure can be folded into a cylindrical structure, and the axis of the cylindrical structure is parallel to the axis of the body. The puncture device for puncturing the atrial septal defect patch in the embodiment of the application can complete atrial septal puncture of the atrial septal defect patch, so that a minimally invasive interventional therapy access from the outside to the left atrium is established for a patient after an atrial septal defect surgery without performing an open chest surgery; the wound formed by the operation is small, the injury to the patient is small, and the patient can recover easily.)

1. A puncture device for puncturing an atrial septal defect patch, comprising a body of a rod-like structure and a puncture member fixedly arranged at the distal end of the body; the puncture component is a sheet structure which is provided with a knife-edge-shaped edge and has an arc-shaped cross section, and the sheet structure can be folded into a cylindrical structure.

2. The lancing device of claim 1, wherein the axis of the cylindrical structure is parallel to the axis of the body.

3. A lancing device according to claim 1 or 2, wherein the knife-edge is a continuous or discontinuous blade or saw tooth configuration;

and/or the presence of a gas in the gas,

the knife edge is disposed on an extension of the inner surface, an extension of the outer surface, or between the inner and outer surfaces of the piercing member.

4. The puncture device for puncturing an atrial septal defect patch as in claim 3, wherein the knife edge is parallel to the inner or outer surface of the puncture member when the knife edge is disposed between the inner and outer surfaces of the puncture member.

5. The puncture device according to claim 1, 2 or 4, wherein the puncture member has a needle body and a needle head for puncturing the atrial septal defect patch, the needle head being integrally formed with or fixedly connected to the needle body, the needle body being integrally formed with or fixedly connected to the body; the knife-edge is arranged on the needle head part, or the knife-edge is arranged on the needle head part and the needle body part.

6. The puncture device for puncturing an atrial septal defect patch as in claim 5, wherein the needle section has a sharp tip, and an arcuate edge that curves toward the needle body or an arcuate edge that curves in a reverse direction toward the needle body;

and/or the presence of a gas in the gas,

the puncture component also comprises a guide part which smoothly connects the needle head part and the needle body part, and the guide part is of a chamfer structure or a fillet structure; the knife-edge is arranged on the needle head part, or on the needle head part and the guide part, or on the needle head part, the guide part and the needle body part;

and/or the presence of a gas in the gas,

the piercing member further comprises a furling portion; the furling part is integrally formed or fixedly connected with the needle body part, and the furling part is integrally formed or fixedly connected with the body.

7. The puncture device for puncturing an atrial septal defect patch as in claim 6, wherein when the puncture member comprises a furled portion, an outer side or edge of the furled portion has a guard structure, the knife edge tending to relax at the guard structure and form a blunt ridge.

8. The puncture device for puncturing an atrial septal defect patch according to claim 1, 2, 4, 6 or 7, wherein the proximal end of the body is provided with a first stop structure for determining the advanced position of the puncture member;

and/or the presence of a gas in the gas,

in the direction perpendicular to the axis of the body, the maximum breadth width of the puncture component is larger than the diameter of the body.

9. The puncture device for puncturing an atrial septal defect patch as claimed in claim 1, 2, 4, 6 or 7, wherein the body is a body made of nitinol;

and/or the presence of a gas in the gas,

the puncture member is made of nickel-titanium alloy.

Technical Field

The application relates to the field of medical equipment, in particular to a puncturing device for puncturing an atrial septal defect patch.

Background

The atrial septal puncture is a necessary route for entering a left heart system from the outside of a body through the right heart in the cardiac intervention, such as mitral valve balloon dilatation, atrial fibrillation radio frequency ablation and the like, and the atrial septal puncture is needed to be firstly carried out. Puncturing the interatrial septum is the first step in the success of the procedure. Currently, the most common interatrial septum puncture needs to adopt an interatrial septum puncture needle and a matched guide wire and sheath.

Atrial septal defect (hereinafter referred to as atrial defect) is a common cardiac surgical disease. Artificial materials commonly used as patches in atrial defect surgical repair procedures include dacron, nylon, polyester fibers, and the like. Wherein, the terylene patch is a common artificial material, is widely used in the surgical operation of the atrial defect and is used for repairing the defective atrial septum. The dacron patch is compact in texture, and the traditional atrial septal puncture needle and the atrial septal puncture guide wire cannot penetrate through the lacuna dacron patch. At present, no puncture device capable of puncturing the atrial septum of the lacking dacron patch in the atrium exists.

Surgical repair of the atrial septum requires suturing of an additional tissue patch to the defective atrial septal border tissue to close the communication between the left and right atria. The common patches comprise two types, namely an autologous pericardium patch or a bovine pericardium patch, and a dacron patch (in view of good biological performance of the dacron patch and superiority of the dacron patch in aging together with blood, the dacron patch is the most common artificial material at present and is widely used for atrial defect surgery). To the first patch postoperative patient, adopt traditional interatrial septum pjncture needle and sheath pipe can accomplish the interatrial septum puncture. And to the patient of second kind of patch postoperative, adopt traditional interatrial septum pjncture needle can not pass through the patch tissue, puncture sheath pipe then can not pass through more. Because the interatrial puncture cannot be completed, the subsequent interventional operation cannot be carried out. These patients can only be performed by a second open chest surgery or epicardial approach.

Firstly, the second thoracotomy operation is complicated and has a high risk. The heart/pericardium of the patients is widely adhered to surrounding tissues after the first thoracotomy, the difficulty of the second thoracotomy is extremely high, and only few domestic experts can carry out the second thoracotomy. Secondly, the epicardial route requires a "dry" pericardial puncture, which is only suitable for a few interventional procedures for arrhythmias originating epicardially, most arrhythmias originating from the endocardium. In addition, the epicardial space is small, and a plurality of catheters are difficult to place for electrophysiological examination and mapping, so that the surgical end point is not clear.

Disclosure of Invention

In view of the above, embodiments of the present application provide a puncturing device for puncturing an atrial septal defect patch that obviates or mitigates one or more of the disadvantages of the related art.

The technical scheme of the application is as follows:

the puncture device for puncturing the atrial septal defect patch comprises a body of a rod-shaped structure and a puncture member fixedly arranged at the distal end of the body; the puncture component is a sheet structure which is provided with a knife-edge-shaped edge and has an arc-shaped cross section, and the sheet structure can be folded into a cylindrical structure.

In some embodiments, the axis of the cylindrical structure is parallel to the axis of the body.

In some embodiments, the knife-edge is a continuous or intermittent blade structure or a saw tooth structure;

and/or the presence of a gas in the gas,

the knife edge is disposed on an extension of the inner surface, an extension of the outer surface, or between the inner and outer surfaces of the piercing member.

In some embodiments, the knife edge is parallel to the inner or outer surface of the piercing member when the knife edge is disposed between the inner and outer surfaces of the piercing member.

In some embodiments, the puncture member has a needle body integrally formed or fixedly connected with the needle body and a needle head for puncturing the atrial septal defect patch, the needle body integrally formed or fixedly connected with the body; the knife-edge is arranged on the needle head part, or the knife-edge is arranged on the needle head part and the needle body part.

In some embodiments, the needle section has a sharp tip and an arcuate edge that curves toward the needle body or an arcuate edge that curves in the opposite direction toward the needle body;

and/or the puncture component also comprises a guide part for smoothly connecting the needle head part and the needle body part, wherein the guide part is in a chamfer structure or a fillet structure; the knife-edge is arranged on the needle head part, or on the needle head part and the guide part, or on the needle head part, the guide part and the needle body part;

and/or the presence of a gas in the gas,

the piercing member further comprises a furling portion; the furling part is integrally formed or fixedly connected with the needle body part, and the furling part is integrally formed or fixedly connected with the body.

In some embodiments, when the piercing member includes a furled portion, the outer side or edge of the furled portion has a guard structure where the knife edge tends to relax and form a blunt ridge.

In some embodiments, the proximal end of the body is provided with a first stop structure for determining the advanced position of the piercing member;

and/or the presence of a gas in the gas,

in the direction perpendicular to the axis of the body, the maximum breadth width of the puncture component is larger than the diameter of the body.

In some embodiments, the body is a body made of a nickel titanium alloy;

and/or the presence of a gas in the gas,

the puncture member is made of nickel-titanium alloy.

According to the puncture device for puncturing the atrial septal defect patch of the embodiment of the application, the obtained beneficial effects at least comprise:

(1) the puncture device for puncturing the atrial septal defect patch in the embodiment of the application can complete atrial septal puncture of the atrial septal defect patch, so that a minimally invasive interventional therapy access which reaches the left atrium in vitro is established for a patient after an atrial defect surgery without performing a thoracotomy.

(2) According to the heart intervention operation that is used for puncturing the puncture device of atrial septal defect patch and accomplishes of this application embodiment, the wound that its art formula formed is less, and the injury that causes the patient is less, and the patient recovers more easily.

Additional advantages, objects, and features of the application will be set forth in part in the description which follows and in part will become apparent to those having ordinary skill in the art upon examination of the following or may be learned from practice of the 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.

It will be appreciated by those skilled in the art that the objects and advantages that can be achieved with the present application are not limited to the specific details set forth above, and that these and other objects that can be achieved with the present application will be more clearly understood from the detailed description that follows.

Drawings

The accompanying drawings, which are included to provide a further understanding of the application, are incorporated in and constitute a part of this application, and are not intended to limit the application. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the application. For purposes of illustrating and describing certain portions of the present application, the drawings may be exaggerated in size, i.e., may be larger, relative to other components in exemplary devices actually manufactured according to the present application. In the drawings:

fig. 1 is a front view schematically illustrating a puncture device according to an embodiment of the present application.

Fig. 2 is another front view of the puncturing device in an embodiment of the present application.

Fig. 3 is a right side schematic view of a lancing device according to an embodiment of the present application.

Fig. 4 is a perspective view of a puncturing device in an embodiment of the present application.

Fig. 5 is a schematic view showing a state in which the puncture device climbs in the dilator according to an embodiment of the present application.

Fig. 6 is a schematic view illustrating a state in which the puncture device climbs out of the dilator according to an embodiment of the present application.

FIG. 7 is a schematic view of a puncturing device for puncturing an atrial septal defect patch in accordance with an embodiment of the present application.

FIG. 8 is a schematic view of another angle of puncturing an atrial septal defect patch by a puncturing device in an embodiment of the present application.

Fig. 9 is a schematic structural view of a puncturing device and a first limiting structure in an embodiment of the present application.

Fig. 10 is a schematic structural view of a puncturing device and a second limiting structure in an embodiment of the present application.

Reference numerals:

1. a body; 2. a piercing member; 21. a needle head section; 211. a needle tip; 212. a gentle section; 213. a guide section; 22. a needle body portion; 23. a gathering part; 231. a protective structure;

10. atrial septal defect patches; 11. a dilator assembly; 110. an expander.

Detailed Description

To make the objects, technical solutions and advantages of the present application more apparent, the present application will be further described in detail with reference to the following embodiments and accompanying drawings. The exemplary embodiments and descriptions of the present application are provided to explain the present application and not to limit the present application.

Here, it should be further noted that, in order to avoid obscuring the present application with unnecessary details, only the structures and/or processing steps closely related to the scheme according to the present application are shown in the drawings, and other details not so relevant to the present application are omitted.

It should be emphasized that the term "comprises/comprising" when used herein, is taken to specify the presence of stated features, elements, steps or components, but does not preclude the presence or addition of one or more other features, elements, steps or components.

It is also noted herein that the term "coupled," if not specifically stated, may refer herein to not only a direct connection, but also an indirect connection in which an intermediate is present.

Hereinafter, embodiments of the present application will be described with reference to the accompanying drawings. In the drawings, the same reference numerals denote the same or similar parts, or the same or similar steps.

An object of the application is to provide a piercing depth for puncturing atrial septal defect patch can realize carrying out the atrial septal puncture through the atrial septal defect patch, to carrying out surgery patch repair postoperative patient ever, puncture through the atrial septal defect patch, establish by the right atrium to the wicresoft intervention treatment route of left atrium to realize the intervention treatment of heart left heart system disease.

In this specification, the distal end refers to an end away from the operator, and the proximal end refers to an end close to the operator.

In some embodiments, as shown in fig. 1 and 3, the puncturing device proposed by an embodiment of the present application may include a body 1 of a rod-like structure and a puncturing member 2 fixedly disposed at a distal end of the body 1; the puncture member 2 is a sheet structure which is provided with a knife-edge-shaped edge and has an arc-shaped cross section, and the sheet structure can be folded into a cylindrical structure.

The cross section of the puncture member 2 is an arc, which means that the cross section of the puncture member 2 is an arc which is not closed into a whole circle in an unfolded state (i.e. the puncture member 2 is not folded); the sheet structure can be folded into a cylindrical structure, namely the sheet structure can be gradually folded into the cylindrical structure and also can be gradually folded into a conical cylindrical structure. Taking the sheet structure as an example, the sheet structure can be gradually folded into a cylindrical structure, and at least a part of the arc structure of the sheet structure can be curled inwards until the sheet structure is rolled into the cylindrical structure; in the process that the sheet structure is gradually folded into the cylindrical structure, the curvature of the cross section of the sheet structure is gradually increased, and the diameter of the cross section of the sheet structure is gradually decreased until the sheet structure is curled into the cylindrical structure, so that the sheet structure has certain toughness. Based on this, the puncture device of the present application is capable of passing over a prior art coupling instrument (typically a sheath or dilator) when the puncture member 2 is crimped into a cylindrical configuration, in order to be self-delivered by the prior art coupling instrument to the atrial septal defect patch between the right atrium and the left atrium. Furthermore, the puncture member 2 of the puncture device according to the present invention has a certain breadth (with an arc cross section) and a blade-shaped edge, so that the puncture member 2 has a certain hardness, when the puncture member 2 advances from the right atrium to the left atrium, the blade-shaped edge of the puncture member 2 can be supported to puncture the atrial septal defect patch, and a larger gap is formed, so that a therapeutic apparatus or a mapping apparatus enters the left atrium from the right atrium along a matching apparatus (generally, a sheath tube), thereby establishing a minimally invasive interventional therapy pathway from the outside of the body to the left atrium through the right atrium, and realizing interventional therapy of heart left heart system diseases. It should be understood by those skilled in the art that when the puncture member 2 of the present application is in an extended state, the length of the projection of the puncture member 2 is greater than the length of the projection of the body 1 (the diameter of the body 1) on a plane perpendicular to the axial direction of the body 1.

In a preferred embodiment, in order to facilitate the puncture device of the present application to be able to smoothly pass through a conventional engagement device (typically, a sheath or a dilator), when the puncture member 2 is rolled (i.e., collapsed) into a cylindrical structure, the axis of the cylindrical structure is parallel to the axis of the body 1.

The main function of the body 1 of the puncturing device of the present application is to transmit forces and torques applied by the operator to the proximal end of the body 1 to the distal end of the body 1 and to the puncturing member 2, whereby the body 1 is preferably solid rod-shaped. The body 1 may also be hollow rod-shaped, as the material used for the body 1 has a good force and moment transmission capability. The hollow shape of the hollow rod may be arbitrary. Fig. 7 and 8 are schematic views showing a state in which the puncturing device of the present application punctures atrial septal defect patch 10. As will be appreciated by those skilled in the art from fig. 7 and 8, as the puncture device advances from the right atrium to the left atrium and traverses atrial septal defect patch 10, the distal end of the knife-like edge of piercing member 2 can pierce through atrial septal defect patch 10 and, during further advancement of piercing member 2 through atrial septal defect patch 10, the knife-like edge can form an arc-like notch in atrial septal defect patch 10, thereby establishing a minimally invasive access to the left atrium from the right atrium to the outside of the body via the right atrium, and for patients undergoing patch repairs, cardiac therapy can be achieved without re-thoracotomy.

Further, during the process of the puncture member 2 passing through the atrial septal defect patch 10, if the axial direction of the puncture member 2 is perpendicular to the atrial septal defect patch 10, the arc length of the widest position of the breadth of the puncture member 2 is substantially equal to the arc length of the arc notch, and if the axial direction of the puncture member 2 is not perpendicular to the atrial septal defect patch 10, the arc length of the widest position of the breadth of the puncture member 2 is smaller than the arc length of the arc notch. In view of this, in order to ensure that the notch formed on the atrial septal defect patch 10 by the puncture member 2 can ensure that the subsequent treatment procedure can be smoothly performed, the puncture device for puncturing the atrial septal defect patch 10 according to the present application is generally selected according to the larger circumference of the treatment instrument and the circumference of the mapping instrument, which are needed to be used later. The criteria for use is that the arcuate length of the piercing member 2 is substantially greater than or equal to 1/2 for the larger circumference.

In the present application, the knife edge of piercing member 2 of the present application may be any shape and configuration capable of piercing a parallel transpunctured atrial septal defect patch. For example, the knife edge may be a continuous or discontinuous blade structure or a saw tooth structure, i.e., the knife edge may be a continuous blade structure, a continuous saw tooth structure, a discontinuous blade structure or a discontinuous saw tooth structure, with a continuous blade structure being preferred.

Meanwhile, the knife edge may be provided on an extended surface of the inner surface of the piercing member 2 (i.e., the inner surface of the piercing member 2 extends toward the distal end of the piercing member 2 and forms a knife shape), on an extended surface of the outer surface of the piercing member 2 (i.e., the outer surface of the piercing member 2 extends toward the distal end of the piercing member 2 and forms a knife shape), or between the inner surface of the piercing member 2 and the outer surface of the piercing member 2 (i.e., the piercing member 2 extends entirely toward the distal end of the piercing member 2 and forms a knife shape between the inner surface of the piercing member 2 and the outer surface of the piercing member 2).

In a specific embodiment, the knife edge is disposed on the inner surface of the puncture member 2 and the outer surface of the puncture member 2, and the knife edge is parallel to the inner surface of the puncture member 2 or the outer surface of the puncture member 2, so that the knife edge is a smooth and coherent structure, which facilitates the puncture member 2 to puncture the atrial septal defect patch 10 smoothly and form an arc-shaped notch.

Still further, the knife edge is closer to the inner surface of the piercing member 2 than to the outer surface of the piercing member 2, such that the knife edge is further from the inner surface of the mating device (typically a sheath or dilator) to prevent it from puncturing the inner surface of the mating device.

In some embodiments, as shown in fig. 1 and 2, the piercing member 2 may have a needle body 22 and a needle head 21 for piercing the atrial septal defect patch, and the needle head 21 may be integrally formed with or fixedly attached to the needle body 22. The needle section 21 is preferably integrally formed with the needle body section 22 so that the connecting portion has high connecting strength and a smooth surface. The integral connection of the needle head part 21 and the needle body part 22 is also suitable for human body interventional medical instruments, so that the connection of the needle head part 21 and the needle body part 22 is stable, certain force and torque can be transmitted, the effect of difficult fracture can be achieved simultaneously, and the needle head part at the far end is prevented from falling off and being lost in a human body in the operation process. The needle body 22 is integrally formed with or fixedly connected to the body 1. The needle body 22 is preferably integrally connected with the body 1 in such a way that the connecting part has high connecting strength and is convenient to process and manufacture.

The knife-edge may be provided to the needle head portion 21, or the knife-edge may be provided to the needle head portion 21 and the needle body portion 22. In one embodiment, in order to facilitate puncturing atrial septal defect patch 10, needle portion 21 is provided with a knife edge on needle portion 21; preferably, in order to enlarge the notch of needle portion 22 for puncturing atrial septal defect patch 10, needle portion 22 is also provided with a knife edge. In other words, the knife edge of needle portion 21 serves to punch the patch through a small gap and the knife edge of needle portion 22 serves to further enlarge the gap for entry of a later treatment or mapping instrument.

In the above embodiment, the needle section 21 has a sharp tip and an arc-shaped edge curved toward the needle body 22 or an arc-shaped edge curved toward the reverse direction of the needle body 22, that is, the needle section 21 may have an outward arc-shaped edge or an inward arc-shaped edge. The knife edge of the needle head part 21 can puncture the atrial septal defect patch, and the far end of the needle head part 21 is designed into a sharp tip, so that the puncturing process can be smoother. The outwardly or outwardly curved edge of tip segment 21 serves to smoothly transition its tip so that the process of tearing the small hole pierced by the distal end of tip segment 21 until an arc-shaped notch is formed is smoother to avoid pulling on the atrial septal defect patch to damage the heart tissue.

In some embodiments, the piercing member further comprises a gathering portion 23; the furled part 23 is integrally formed or fixedly connected with the needle body part 22, and the connection mode of the furled part 23 and the needle body part 22 is preferably integrally formed so as to have higher connection strength and smooth surface. The gathering part 22 is integrally formed with the body 1 or fixedly connected thereto, for example, the fixed connection may be a non-releasable press connection. A furl 23 is located at the distal end of the puncture member to guide the already spread puncture member smoothly into the dilator.

In some embodiments, the needle section 21 may further include a guide portion smoothly connecting the needle section 21 and the needle body 22, and the guide portion 213 may be a chamfered structure or a rounded structure. As shown in fig. 2, the distal end of needle section 21 is needle tip 211, and needle section 21 may also have a flat section 212. Further, the guide 213 may have a chamfered structure or a rounded structure. Guide 213 serves to smoothly connect needle body 22 to needle head 21 in both radial and circumferential directions to enhance the smoothness and continuity of the piercing member during puncturing atrial septal defect patch 10 and enlarging the notch.

In some embodiments, the piercing member may further comprise a gather 23; the gathered portion 23 is integrally formed or fixedly connected with the needle body portion 22, preferably integrally formed, so that the connecting portion has high connecting strength and a smooth surface. The integral connection of the furling part 23 and the needle body part 22 is also suitable for human body intervention medical appliances, so that the connection of the furling part and the needle body part is stable, certain force and torque can be transmitted, and the effect of difficult fracture can be achieved at the same time. The gathering part 22 is integrally formed or fixedly connected, preferably integrally formed, with the body 1. A furl 23 is located at the proximal end of the puncture member and is primarily used to guide the already spread puncture member smoothly into the dilator.

In some embodiments, the maximum dimension of the cross section of said tip segment 21 is smaller than or equal to the maximum diameter dimension of said body 1, so that the tip segment 21 is guided into the dilator 110. The shape of the needle tip 211 may be an arc structure, a triangular structure, an elongated triangular prism along the axial direction thereof, a pyramidal structure, etc. As shown in FIG. 4, the tip 211 is preferably shaped in an arcuate configuration.

Further, the blade-like edge is formed by an inner blade extending from the inner surface of the pricking member 2 and an outer blade extending from the outer surface of the pricking member 2. A blade-like edge is provided on the tip segment 21 and the guide portion 213, or on the tip segment 21, the guide portion 213, and the needle body 22. Preferably, the needle head 21, the guide 213 and the needle body 22 have a knife-edge to avoid uneven or sudden increase of the pressure applied to the patch by the piercing member when piercing the patch.

In some embodiments, the needle section 21 is a rectangular sheet-like structure after being unfolded, the needle body section 22 is a rectangular sheet-like structure after being unfolded, and the size of the rectangular sheet-like structure after being unfolded of the needle body section 22 is larger than that of the rectangular sheet-like structure after being unfolded of the needle section 21. In other embodiments, the needle head portion 21 has a fan-shaped sheet structure after being spread out, the needle body portion 22 has a rectangular sheet structure after being spread out, and the size of the rectangular sheet structure of the needle body portion 22 is larger than that of the fan-shaped sheet structure of the needle head portion 21.

In some embodiments, the gathering portion 23 may be a structure that gradually decreases in diameter in a direction toward the body 1. The furled portion 23 may be a fan-shaped sheet structure after being unfolded.

When the piercing member 2 includes a furled portion 23, as shown in fig. 4, the outer side or edge of the furled portion 2 has a guard structure 231, and the knife edge tends to relax and form a blunt ridge at the guard structure 231.

The furl portion 23 of the present embodiment facilitates furling the puncturing device for puncturing an atrial septal defect patch of the present application in an unfolded state to a mating instrument (e.g., dilator 110) external thereto. The length of the shielding structure 231 is smaller than the length of the furled portion 23, so that when the puncturing device for puncturing an atrial septal defect patch of the present application is passed through the dilator 110, the knife edge of the piercing member 2 is spaced from the inner wall of the expander 110, thereby protecting the knife-edge of the piercing member 2 from contact with the inner wall of the dilator 110, and as the puncturing device for puncturing an atrial septal defect patch of the present application is advanced into the distal end of dilator 110, the guard structure 231 can "crawl" through the constricted section of the channel in the dilator 110, so as to avoid the contact between the needle head portion 21 and the inner wall of the distal end of the dilator 110, ensure that the needle head portion 21 smoothly enters the contraction section of the distal end of the dilator 110, thereby protecting the knife-edge and substantially avoiding debris generation within the dilator 110, which could lead to serious intraoperative thrombosis and the like.

In some embodiments, as shown in fig. 9, the proximal end of the body 1 is provided with a first stop structure 31 for determining the advanced position of the piercing member, and the first stop structure 31 may be a lock pusher. After the locking pusher is locked, the locking pusher is matched with a luer connector at the tail end of the dilator to complete limiting.

Preferably, the proximal end of the body 1 may also carry at least one location indicator, for example a first location indicator may indicate that the piercing member is flush with the distal end of the dilator and a second location indicator may indicate that the piercing member has been extended by a proposed length, i.e. a portion of the length of the piercing member.

In some embodiments, as shown in fig. 10, the distal end of the penetrating member 2 may be provided with a second stop structure 32, such that the second stop structure 32 can limit the penetrating member 2 from continuing to penetrate the atrial septal defect patch 10 after the penetrating member 2 is extended from the distal end of the dilator 110 and deployed.

The overall structure of the body 1 and the piercing member 2 is substantially rod-shaped, ensuring the best possible transmission of force. The body 1 can be made of nickel-titanium alloy, and/or the puncture member 2 can be made of nickel-titanium alloy, the nickel-titanium alloy has certain strength, and the nickel-titanium alloy has good memory and elasticity after heat treatment and shaping.

The puncture member 2 according to the embodiment of the present application can be curled, and can pass through the dilator 110 in a curled state; the inner wall of the expander 110 can not be scratched when the expander is threaded; the puncture member 2 is deployable and in its deployed state is capable of puncturing the atrial septal defect patch 10 to form a notch. The gap enables the passage of a subsequent treatment or mapping instrument, thereby allowing a patient with atrial septal defect patch 10 to establish a treatment access to the left atrium outside the body. The puncture member 2 can be stopped (having both proximal and distal stop structures) after extending from the dilator 110 to ensure that the puncture member 2 can be safely withdrawn without touching (scratching) the inner wall of the left atrium, the ostium of the pulmonary vein, or other tissues after passing through the atrial septal defect patch 10. The overall structure is substantially rod-like, ensuring the best force transmission.

The puncture device and puncture set for puncturing an atrial septal defect patch according to the present application shown in fig. 1 to 10 will be described as an example of the surgical procedure.

The main apparatus required by the atrial septal puncture of the atrial septal defect patch comprises a sheath tube, a dilator 110, a puncture device for puncturing the atrial septal defect patch and a guide wire.

A guide wire, the distal end of which is provided with a soft part which can freely pass through the dilator 110;

a dilator 110 provided with a constriction at its distal end; the inner diameter of the contraction section is gradually reduced from the proximal end of the contraction section to the distal end of the contraction section; the dilator 110 can freely pass through the sheath;

a puncture device for puncturing the atrial septal defect patch, which can freely pass through the dilator 110;

the sheath tube has a distal opening capable of being fittingly sleeved over the proximal end of the dilator 110.

In the using process:

in the first step, the sheath and dilator 110 are advanced into the superior vena cava using a guide wire. The method comprises the following specific steps: firstly, pushing the guide wire into the superior vena cava, then sleeving the sheath tube outside the dilator 110, sleeving the dilator 110 outside the guide wire, and pushing the sheath tube and the dilator 110 into the superior vena cava along the guide wire; whether the sheath and dilator assembly 11 has entered the superior vena cava can be confirmed by X-ray imaging (a commonly used imaging technique in medicine) or ultrasound imaging, or by injection of a contrast agent;

secondly, withdrawing the guide wire and the dilator 110, sleeving the puncture device for puncturing the atrial septal defect patch in the dilator 110, and pushing the dilator 110 and the puncture device to the distal end of the sheath along the sheath;

third, the sheath assembly (sheath, dilator 110, and puncture device used to puncture the atrial septal defect patch) is pulled to slide down the superior vena cava until the distal end of the dilator 110 reaches the predetermined atrial septal puncture site. Can be confirmed by observing whether the sheath tube assembly bounces or is ultrasonically detected in X-ray imaging;

fourthly, the whole assembly is continuously advanced until the distal end of the dilator 110 abuts against the atrial septal defect patch 10 (when the distal end of the dilator is continuously advanced, resistance can be felt on hand, or the atrial septal defect patch 10 can be seen to be umbrella-shaped in an ultrasonic image), and the puncture device for puncturing the atrial septal defect patch is advanced until the needle tip part 211 of the puncture member 2 punctures the atrial septal defect patch 10;

fifth, the entire assembly is advanced until the needle body 22 and dilator 110 enter the left atrium in sequence, e.g., the first stop structure or the second stop structure limits the puncture device to advance further distally along the sheath; withdrawing the puncture device for puncturing the atrial septal defect patch along the dilator 110, gradually withdrawing the withdrawing part 23 along the distal opening of the dilator 110 until the dilator is curled into the dilator 110, and continuously withdrawing the puncture device until the puncture member 2 is slowly withdrawn from the dilator 110; advancing the sheath along dilator 110 until the sheath enters the left atrium; the dilator 110 and puncture device are then withdrawn.

According to the puncture device for puncturing the atrial septal defect patch of the embodiment of the application, the obtained beneficial effects at least comprise:

(1) the puncture device for puncturing the atrial septal defect patch in the embodiment of the application can complete atrial septal puncture of the atrial septal defect patch, so that a minimally invasive interventional therapy access which reaches the left atrium from the outside is established for a patient after an atrial septal defect surgery without performing a thoracotomy.

(2) According to the heart intervention operation that is used for puncturing the puncture device of atrial septal defect patch and accomplishes of this application embodiment, the wound that its art formula formed is less, and the injury that causes the patient is less, and the patient recovers more easily.

Features that are described and/or illustrated with respect to one embodiment may be used in the same way or in a similar way in one or more other embodiments and/or in combination with or instead of the features of the other embodiments.

The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and it will be apparent to those skilled in the art that various modifications and variations can be made in the embodiment of the present application. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application.