WO2020199233A1

WO2020199233A1 - Puncturing system and method used for transcatheter puncture of interventricular septum

Info

Publication number: WO2020199233A1
Application number: PCT/CN2019/081856
Authority: WO
Inventors: 闫朝武; 郝世杰
Original assignee: 闫朝武
Priority date: 2019-04-02
Filing date: 2019-04-09
Publication date: 2020-10-08

Abstract

Disclosed are a puncturing system and method used for transcatheter puncture of interventricular septum. The puncturing system comprises a puncture needle (1) made of nickel-titanium memory alloy and a puncture sheath (3) in a hollow tube shape. The puncture needle (1) comprises a tip (11) and a tail (12). An operating handle (2) is connected to the tail (12) of the puncture needle (1). The tip (11) of the puncture needle (1) is pre-arranged to be smoothly curved, so that the tip (11) of the puncture needle (1) is smoothly curved and the hardness of the tip increases when the temperature of the puncture needle (1) is greater than the phase transition temperature, and the hardness of the puncture needle (1) decreases when the temperature of the puncture needle (1) is lower than the phase transition temperature. The sheath (3) allows the puncture needle (1) to penetrate freely, and is bent in a corresponding shape at a position corresponding to the tip (11) of the puncture needle (1). The puncture needle (1) used is made of memory alloy; when the temperature of the puncture needle (1) is greater than the phase transition temperature, the hardness and the bending angle of the tip (11) of the puncture needle (1) are automatically changed to facilitate puncturing the interventricular septum.

Description

Needle system and method for transcatheter heart ventricular septal puncture

Technical field

The invention relates to a needle system and method for transcatheter heart ventricular septum puncture.

Background technique

With the development of interventional surgery of the left heart system, especially the development of new technologies such as transcatheter aortic valve implantation, transcatheter mitral valve repair/implantation, transcatheter left ventricular subendocardial pacing, etc., percutaneous It is very important to obtain a safe and effective way to enter the left heart system (mainly including the aorta, left ventricle and left atrium) through the catheter. However, there are many shortcomings in the current clinical application of the path into the left heart system.

At present, there are two main ways to enter the left ventricular system through a percutaneous catheter: (1) enter the left ventricular system retrogradely through the femoral artery or other peripheral arteries; (2) enter the left ventricular system antegrade through the femoral vein puncture the atrial septum. However, both methods have serious limitations when large sheaths need to be delivered. The former is restricted by the diameter and course of the peripheral arteries. In addition, the angle into the left heart system is too large, which is not conducive to the delivery of the thick sheath and greatly increases the complications related to surgery. The latter also faces the problem of too large an angle of entry, resulting in not widely used clinically. Therefore, there is an urgent need for a brand-new device and method to solve the above problems in clinical practice.

Accordingly, there is an urgent need in the art for a new needle system and method for transcatheter cardiac ventricular septal puncture to solve the above problems.

Summary of the invention

The purpose of the present invention is to provide a needle system and method for transcatheter heart ventricular septal puncture, which can effectively solve the problem of excessively large angles entering the left heart system and facilitate the completion of ventricular septal puncture. For this purpose, one aspect of the present invention provides a lancet system for transcatheter cardiac ventricular septal puncture. The lancet system includes a lancet made of nickel-titanium memory alloy and a lancet sheath in a hollow tube shape.

The lancet includes a tip and a tail; an operating handle is connected to the tail of the lancet, wherein when the temperature of the lancet is higher than its heating phase transition temperature, the tip of the lancet is smoothly curved and the hardness increases. When the temperature of the puncture needle is lower than its cooling phase transition temperature, the hardness of the puncture needle decreases;

The lancet sheath allows the lancet to penetrate freely, and is bent in a corresponding shape at a position corresponding to the tip of the lancet.

Further, the operating handle is detachably connected to the tail of the lancet.

Further, the operating handle includes a direction indicating label, and the direction indicated by the direction indicating label is consistent with the bending direction of the lancet tip or is at a fixed angle.

Further, the bending angle of the tip of the puncture needle is any value between 30° and 90°.

Further, the length of the curved section of the tip of the puncture needle is any value between 1 cm and 3 cm.

Further, the temperature rise phase transition temperature of the lancet is any temperature range between 20°C and 35°C, and the temperature drop phase transition temperature is any temperature range between 0°C and 25°C.

Further, when the temperature of the lancet is higher than the temperature of the temperature rising phase transition temperature, its elastic modulus is any value between 50 GPa and 100 GPa, or

When the temperature of the lancet is lower than the cooling phase transition temperature, its elastic modulus is any value between 20 GPa and 60 GPa.

Further, an annular mark is provided at one end of the lancet sheath corresponding to the tip of the lancet, and the annular mark can be visually identified under X-rays.

Further, at one end of the thorn sheath corresponding to the tip of the puncture needle, the thorn sheath gradually becomes tapered in a certain distance gradually approaching the end.

In another aspect of the present invention, there is also provided a method for transcatheter cardiac ventricular septal puncture, the method comprising:

Deliver the stab sheath into the left ventricle/right ventricle;

When the temperature of the lancet is lower than the cooling phase change temperature, the lancet is fed into the lancet sheath and the tip of the lancet does not protrude from the end of the lancet;

Let it stand for a certain period of time, so that the temperature of the lancet is higher than the temperature-increasing phase transition temperature, so that the tip of the lancet is smoothly curved;

After determining the puncture position, fix the puncture sheath and push the puncture needle through the interventricular septum into the right ventricle/left ventricle;

Fix the lancet and push the lancet sheath so that the lancet enters the right ventricle/left ventricle along the lancet;

Withdraw the lancet and keep the lancet for use.

The advantages of the present invention are:

The puncture needle system for transcatheter cardiac ventricular septum puncture provided by the present invention, the puncture needle is made of nickel-titanium memory alloy, the tip of the puncture needle is set to be smoothly curved, when the temperature of the puncture needle is lower than its phase transition temperature, the whole is soft It is linear and is convenient for delivery into the ventricle with the lancet sheath. When the temperature of the lancet is higher than the phase transition temperature, the tip of the lancet is smoothly curved, which effectively changes the rigidity of the lancet and the angle of the tip in the ventricle, facilitating the operation Interval puncture.

Furthermore, the method used for transcatheter heart ventricular septal puncture has an ideal puncture needle system entry angle, high surgical success rate, and greatly reduces surgical complications.

Description of the drawings

Fig. 1 is a schematic diagram of a lancet structure in an embodiment of the present invention.

Figure 2 is a schematic diagram of a barbed sheath in an embodiment of the present invention.

Fig. 3 is a schematic diagram of the main structure of a needle system for transcatheter cardiac ventricular septal puncture in an embodiment of the present invention.

Fig. 4 is a schematic diagram of the main steps of a method for transcatheter cardiac ventricular septal puncture in an embodiment of the present invention.

Fig. 5 is a schematic diagram of a state in which a barbed sheath is fed into the middle of the left ventricle under the cooperation of a guide wire in an embodiment of the present invention.

Fig. 6 is a schematic diagram of a state in which a puncture needle enters the left ventricle through the puncture sheath in an embodiment of the present invention.

Fig. 7 is a schematic diagram of a state in which the tip of a lancet punctures the interventricular septum from the left ventricle into the right ventricle in an embodiment of the present invention.

Fig. 8 is a schematic diagram of a state in which the lancet sheath is fixed after the lancet is withdrawn in an embodiment of the present invention.

Fig. 9 is a schematic diagram of a state in which a long guide wire is fed into the right ventricle-pulmonary artery through the femoral artery from the stab sheath in an embodiment of the present invention.

Fig. 10 is a schematic diagram of a femoral artery-femoral vein vascular track in an embodiment of the present invention.

Fig. 11 is a schematic diagram of a state in which two ends of a fixed vascular track outside the body are fixed, and a thick sheath is fed into the aorta through the femoral vein along the vascular track in an embodiment of the present invention.

Fig. 12 is a schematic diagram of a state of adjusting and retracting a thick sheath to a target position in an embodiment of the present invention.

Fig. 13 is a schematic diagram of a state where a thick delivery sheath is viewed from the right ventricular surface and enters the aorta through the femoral vein across the ventricular septum in an embodiment of the present invention.

Fig. 14 is a schematic diagram of a femoral vein-femoral vein vascular track established by puncturing the cardiac ventricular septum and atrial septum simultaneously in an embodiment of the present invention.

15 is a schematic diagram of a state in which a large sheath passes across the interventricular septum and enters the left ventricle and the left atrium through the femoral vein along the vascular track in an embodiment of the present invention.

Fig. 16 is a schematic diagram of a track of subclavian vein-right ventricle-ventricular septum-left ventricle-femoral artery in an embodiment of the present invention.

Fig. 17 is a schematic diagram of a state of implantation of a left ventricular subendocardial pacing electrode via a subclavian vein ventricular septal route in an embodiment of the present invention.

detailed description

The present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments.

Referring to Figures 1 to 3, as shown in the figure, the lancet system for transcatheter cardiac septal puncture includes a lancet 1 made of nickel-titanium memory alloy. The lancet 1 includes a tip 11 and a tail 12; an operating handle 2 Connect the tail 12 of the puncture needle 1; the puncture needle 1 is set so that when the temperature of the puncture needle 1 is higher than its heating phase transition temperature, the tip 11 of the puncture needle 1 is smoothly bent and the hardness increases, and when the temperature of the puncture needle 1 is lower than the cooling phase transition temperature , The hardness of the puncture needle 1 decreases linearly (as shown by the dotted line in Figure 1). The lancet sheath 3 is a hollow tube for the lancet 1 to penetrate freely, and is bent in a corresponding shape at a position corresponding to the tip 11 of the lancet 1.

Specifically, the puncture needle 1 made of nickel-titanium memory alloy may be solid or hollow. It utilizes the memory characteristics of memory alloy to set the tip 11 of the lancet 1 to be smoothly curved. When the temperature of the lancet is lower than the cooling phase transition temperature, the lancet 1 is linear and flexible as a whole, which is convenient for fitting with the lancet 3 in the artery or vein. Travel through. Preferably, the temperature rise phase transition temperature of the lancet 1 is any temperature range between 20°C and 35°C, for example, the temperature rise phase transition temperature is 20°C to 25°C, 20°C to 30°C, 20°C to 35°C, 25°C to 30°C, 22°C to 30°C, 23°C to 30°C, etc., but not limited to this. The cooling phase transition temperature of the lancet 1 is any temperature range between 0℃ and 25℃, for example, the cooling phase transition temperature is 0℃-25℃, 20℃-25℃, 15℃-25℃, 15℃-20℃, etc. , But not limited to this. In this embodiment, the puncture needle 1 is set so that when the temperature of the puncture needle 1 is lower than 20°C, the whole is soft and easy to be straightened; when the temperature of the puncture needle 1 is higher than 30°C, the tip 11 of the puncture needle 1 is smoothly curved and the hardness increases. That is, when the temperature of the lancet 1 is lower than 20°C, the lancet 1 is soft and the hardness is weak; when the temperature of the lancet 1 is higher than 30°C, the tip 11 automatically bends at a fixed angle and the hardness increases, providing a powerful force for puncture of the interventricular septum support. That is, during surgery, when the lancet 1 is sent into the patient's ventricle, the temperature of the tip 11 of the lancet 1 is higher than its temperature-increasing phase transition temperature by using the patient's body temperature, thus presenting a smooth curve of memory and an increase in hardness. To facilitate the puncture of the interventricular septum. The diameter of the lancet 1 can be 0.032 inches, 0.035 inches, and 0.038 inches, but it is not limited thereto.

Further, using the shape memory characteristics of the nickel-titanium memory alloy, the length of the curved section of the tip 11 of the lancet 1 can be any value between 0.5cm and 3cm, that is, when the tip 11 of the lancet 1 recovers its memory shape, its The length of the bending section can be any value between 0.5 cm and 3 cm, and the specific length can be preset accordingly according to actual requirements. The distance between the tip 11 of the lancet 1 and the tip of the lancet 1 can also be any value between 0cm and 3cm, that is, the distance between the curved section and the tip can be any value between 0cm and 3cm, and the distance between the tip 11 and the tip can be Pre-adjust settings according to actual needs, preferably 0cm, 0.5cm, 1.5cm, 2cm. The bending angle of the tip 11 of the lancet 1 is preset, and can be any value between 30° and 90°. Preferably, the bending angle is 45° and 60°. The bending angle is the angle (acute angle) between the two ends of the bending section (start and end point of the bending section) corresponding to the tangent. The bending angle can be adjusted in advance according to actual needs.

It should be noted that when the lancet 1 is higher than the temperature rising phase transition temperature, within a certain temperature range, as the temperature increases, its hardness gradually increases. When the lancet 1 is lower than the cooling phase transition temperature, within a certain temperature range, as the temperature decreases, its hardness gradually decreases. In other words, the hardness of the puncture needle 1 will change accordingly with changes in temperature.

Further, when the temperature of the lancet 1 is higher than the temperature of the temperature rising phase transition temperature, its elastic modulus is any value between 50 GPa and 100 GPa, or when the temperature of the lancet 1 is lower than the temperature of the temperature lowering phase transition temperature, its elastic modulus is from 20 GPa to 60 GPa. Any value in between. It should be noted that, for the same lancet, its elastic modulus when the temperature is higher than the temperature rise phase transition temperature is greater than its elastic modulus when it is lower than the temperature drop phase transition temperature.

Specifically, the operating handle 2 includes a direction indicating label, and the direction indicated by the direction indicating label is consistent with the bending direction of the tip 11 of the lancet 1 or is at a fixed included angle (for example, an included angle of 180°), which facilitates identification and manipulation of the orientation of the tip 11 . The operating handle 2 and the tail 12 of the lancet 1 may be detachably connected, or fixedly connected, or integrally formed. In application, the tip 11 of the lancet 1 can also be provided with a protective cover, which protects the lancet 1 and facilitates the delivery of the lancet 1 into the lancet 3 at the same time.

Referring to Figure 2, Figure 2 exemplarily shows the main structure of the barbed sheath, as shown in 2, at the end of the barbed sheath 3 corresponding to the tip 11 of the lancet 1 is provided with a ring mark (not shown in the figure), the ring mark is It can be visualized and identified under X-ray, which is convenient for positioning the distance between the tip 11 of the lancet 1 and the end exit of the lancet 3 during surgery. At one end of the barbed sheath 3 corresponding to the tip 11 of the lancet 1, the barbed sheath 3 is gradually tapered in a certain distance gradually approaching the end. Specifically, it can be any length between 0.1 cm and 2 cm near the end of the barbed sheath 3, preferably, a gradual tapering transition with a length of 0.5 cm, 1 cm, 1.5 cm, and 2 cm to make the end exit sharp, It is beneficial for the lancet 3 to cross the ventricular septal myocardium along the lancet 1 and enter the ventricle.

Specifically, the length of the barbed sheath 3 can be any length between 90 cm and 120 cm, and the outer diameter of the barbed sheath 3 can be 4F, 5F, 6F. Correspondingly, the length of the lancet 1 can be any length between 90cm and 120cm and longer than the lancet 3. The lancet 3 with an outer diameter of 4F is used in conjunction with the lancet 1 of 0.032 inches, and the lancet 3 with an outer diameter of 5F is 0.035 inches. The lancet 1 is used together with the lancet 3 with an outer diameter of 6F and the lancet 1 of 0.038 inches is used together. Preferably, the material of the barbed sheath 3 is polyethylene.

Based on the above-mentioned needle system for transcatheter heart ventricular septum puncture, the present invention also provides a method for transcatheter heart ventricular septum puncture. The method for transcatheter cardiac ventricular septal puncture provided by the present invention will be described in detail below with reference to the accompanying drawings.

Referring to FIG. 4, FIG. 4 exemplarily shows the main steps of the method for transcatheter cardiac ventricular septal puncture. As shown in FIG. 4, the method includes:

Step S1: Send the thorn sheath 3 into the left ventricle/right ventricle;

Step S2: when the temperature of the lancet 1 is lower than the phase transition temperature, the lancet 1 is fed into the lancet 3 and the tip 11 of the lancet 1 does not extend out of the end of the lancet 3;

Step S3: Let it stand for a certain period of time, so that the temperature of the lancet 1 is higher than the phase transition temperature, so that the tip of the lancet 1 is smoothly curved;

Step S4: After determining the puncture position, fix the lancet 3 and push the lancet 1 through the interventricular septum into the right ventricle/left ventricle;

Step S5: Fix the puncture needle 1 and push the puncture sheath 3 so that the puncture sheath 3 enters the right ventricle/left ventricle along the puncture needle 1;

Step S6: Exit the lancet 1 and keep the lancet 3 for future use.

The puncture system and method for transcatheter cardiac ventricular septal puncture provided by the present invention establish a brand-new technical platform and have a wide range of clinical applications. It can be applied but not limited to the following diseases: transcatheter aortic valve implantation, transcatheter mitral valve repair or mitral valve replacement, transcatheter left ventricular endocardial pacing, etc.

Transcatheter aortic valve implantation: When aortic valve stenosis or insufficiency occurs, artificial valve implantation is required to replace the diseased native valve. Traditional cardiac aortic valve surgery requires general anesthesia, surgical thoracotomy and assisted by extracorporeal circulation. Because it is a highly invasive surgery, the associated surgical risk is relatively high. In recent years, with the development of transcatheter aortic valve implantation (TAVR), minimally invasive interventional treatment of aortic valve disease has achieved good results, and greatly reduced the patient's surgical risk. However, the current path for TAVR has major flaws. At present, the known routes of TAVR mainly include the following: ① via the femoral artery or other large peripheral arteries; ② via the apical approach; ③ via the femoral vein-inferior vena cava-abdominal aorta. So far, most TAVRs have adopted the retrograde approach through the femoral artery. The main drawback is that it is limited by the anatomy of the femoral artery, and it is often difficult to operate when the blood vessel is diseased or severely tortuous. In addition, this approach causes the entrance angle to be too large when the sheath is delivered. , The lack of support for the sheath at the distal end and other defects also restrict its application. The transapical approach can provide the best angle of entry, but requires minimally invasive surgery to puncture the apex, which increases the risk of surgery. Although the transfemoral vein-inferior vena cava-abdominal aorta approach solves the limitation of femoral artery vascular anatomy, it still cannot solve the defect of large entry angle, and in the process of puncturing the inferior vena cava-abdominal aorta, its retroperitoneum The risk of bleeding has increased significantly. Therefore, a new approach is urgently needed clinically to overcome the limitations of the current method.

Transcatheter mitral valve repair or mitral valve replacement: After severe mitral valve regurgitation occurs, mitral valve repair or mitral valve replacement is required. At present, in addition to traditional surgical thoracotomy, transcatheter micro Invasive intervention for mitral valve clamping or mitral valve replacement is receiving more and more attention. In the process of transcatheter interventional treatment of the mitral valve, there are two main routes, namely, the femoral vein-atrial septum puncture into the left atrium and the transapical puncture into the left ventricle and then cross the mitral valve into the left atrium. The entrance angle of the sheath tube of the former is too large, which causes great interference to the surgical operation and severely restricts the size of the delivery device; the latter, as mentioned above, requires surgical assistance, which increases the risk of surgery. Therefore, there is an urgent need for a new approach to overcome the limitations of current methods in clinical practice.

Transcatheter left ventricular endocardial pacing: During the implantation of cardiac pacemakers, the current clinically commonly used method is right atrium and right ventricular pacing; however, right ventricular pacing artificially changes the sequence of cardiac pacing, forming a complete pattern Left bundle branch block; this brings potential harm to the left ventricular function of most patients; although the coronary sinus-coronary vein approach can solve this problem to a certain extent, it is still difficult to achieve in some patients due to anatomical variations and other reasons . Therefore, there is an urgent need for a new approach to overcome the limitations of current methods in clinical practice.

Based on the puncture system and method for transcatheter cardiac ventricular septum puncture provided by the present invention, a brand-new way of entering the left heart system across the ventricular septum through the femoral vein can be realized, that is, through a newly designed nickel-titanium alloy puncture needle and a matching needle The puncture sheath enters the left ventricle through the femoral artery to achieve ventricular septal puncture. The femoral artery-femoral vein track is established by the method of snare of the long guide wire, and then the corresponding puncture sheath is transported from the femoral vein into the left heart system along the track. There are many variations of this method according to clinical needs, including but not limited to: (1) femoral artery-ventricular septum-femoral vein track; (2) femoral vein-atrial septum-ventricular septum-femoral vein track, which is a transcatheter mitral Valve repair/replacement provides an ideal vascular track; (3) Subclavian vein-ventricular septum-femoral artery track, providing vascular track for transcatheter left ventricular endocardial pacing.

In more detail, the present invention provides a method for transcatheter cardiac ventricular septal puncture, which can achieve a safe and effective method to puncture the ventricular septum into the right ventricular cavity through the femoral artery in the left ventricular cavity, and then according to clinical differences Different vascular orbits can be established according to the requirements, including but not limited to: (1) Femoral artery-femoral venous tract, including femoral artery-aorta-left ventricle-ventricular septum-right ventricle-right atrium-inferior vena cava-femur Veins (as shown in Figure 10). Through this track, enter the aorta via the femoral vein through the interventricular septum, and perform transcatheter aortic valve implantation. (2) Femoral vein-femoral vein track, at the same time puncture the atrial septum, the track includes femoral vein-right atrium-atrial septum-left atrium-left ventricle-ventricular septum-right ventricle-right atrium-femoral vein, which is the transcatheter mitral Valve repair/replacement provides an ideal track (as shown in Figure 14); (3) Subclavian vein-femoral artery track, including subclavian vein-superior vena cava-right atrium-right ventricle-ventricular septum-left ventricle-aorta -The femoral artery (shown in Figure 16) provides a track for transcatheter left ventricular endocardial pacing.

Based on the method for transcatheter heart ventricular septal puncture provided by the present invention, the operation success rate is high, the stab sheath enters the ventricle at an ideal angle, the channel can provide the best support force, and the operation-related complications are greatly reduced.

Furthermore, the method for transcatheter cardiac ventricular septum puncture provided by the present invention can puncture the ventricular septum through the left ventricular surface of the femoral artery, which facilitates the accurate positioning and puncture of the ventricular septum.

Further, the method for transcatheter cardiac ventricular septal puncture provided by the present invention can be established according to clinical needs through the puncture sheath that enters the right ventricular cavity after puncturing the interventricular septum into the right ventricular cavity, combined with the application of a long guide wire and a snare Different vascular tracks provide safe and excellent supporting channels for subsequent treatment. Commonly used vascular tracks include but are not limited to the following three types, namely, femoral artery-femoral vein track, femoral vein-femoral vein track, and subclavian vein-femoral artery track.

Further, the method for transcatheter cardiac ventricular septal puncture provided by the present invention may also include sending a balloon of appropriate diameter through the femoral vein route to perform balloon pre-dilation at the ventricular septal puncture along the established channel, Provide a smoother passage for the subsequent delivery of the thick sheath through the channel.

Further, the method for transcatheter cardiac ventricular septal puncture provided by the present invention may also include puncturing the interventricular septum and atrial septum based on the puncture needle and lancet sheath to establish a femoral vein-femoral vein orbit, which is a way to enter the interventricular septum via the femoral vein. Mitral valve interventional therapy in the left atrium provides a safe and extremely supportive channel.

Further, the method for transcatheter cardiac ventricular septum puncture provided by the present invention may further include: after the puncture needle system punctures the interventricular septum, the snare is fed into the superior vena cava or the pulmonary artery to snare the end of the long guide wire through the subclavian vein In order to establish a new track of subclavian vein-right atrium-right ventricle-ventricular septum-left ventricle-aorta-femoral artery, providing for the implantation of left ventricular subendocardial pacing electrode via the subclavian vein-ventricular septum route Safe and effective channel (as shown in Figure 17).

The method for transcatheter heart ventricular septal puncture provided by the present invention will be described in detail below in conjunction with specific embodiments.

1. Preoperative preparation:

Disinfect both sides of the groin area; routinely puncture the femoral artery and vein for backup;

The pigtail catheter is fed through the femoral artery into the left ventricle, and the pigtail catheter is fed through the femoral vein into the right ventricle, in the tangential position of the cardiac ventricular septum (the left anterior oblique position is the best, which fully shows the left ventricular outflow tract part of the anterior ventricular septum, which is convenient for positioning ) Perform bilateral ventriculography to evaluate the morphology of the left and right ventricles and the ventricular septum;

The lancet 1 is placed in sterile frozen heparinized normal saline to lower the temperature for later use. The lancet preset in the metal protective sheath is soft and facilitates the delivery of the lancet 3.

2. Cardiac ventricular septal puncture and establishment of femoral artery-femoral vein trajectory through the ventricular septum:

Step S101: The position of the pigtail catheter in the right ventricle remains unchanged, which is convenient for reference positioning during puncture; exchange the sheath through the femoral artery and enter the middle of the left ventricle (as shown in Figure 5);

Step S102: Sterile frozen heparinized normal saline is exhausted and filled into the puncture sheath; then the puncture needle 1 cooled by the ice water is quickly fed into the puncture sheath 3, and the tip 11 of the puncture needle 1 is close to the distal opening of the puncture sheath 3 But the tip does not show the circular mark of the puncture sheath 3. Make sure that the tip 11 is in the puncture sheath 3;

Step S103: Place the lancet 1 and sheath 3 in the left ventricular cavity for about 10-20 seconds. As the temperature rises, the tip 11 of the lancet 1 automatically bends and the hardness increases rapidly; rotate the operating handle of the tail 12 of the lancet 1 2. Make the bent lancet 1/the distal end of the lancet 3 point vertically to the middle of the interventricular septum (as shown in Figure 6);

Step S104: fluoroscopy and ultrasound positioning, and further confirm the position of the distal end of the lancet 1/stent 3 on the left ventricular surface of the ventricular septum;

Step S105: After confirming that the puncture position is appropriate, fix the lancet 3 and push the lancet 1, obliquely 30° to 90° through the left ventricular septum (muscle part) into the right ventricular cavity (as shown in Figure 7). In-depth reference to preoperative angiography;

Step S106: Determine whether the distal end of the lancet 1 enters the right ventricular cavity by ultrasound, to prevent insufficient puncture to pass the ventricular septum or excessive puncture to damage the right ventricular wall or other tissues;

Step S107: After confirming that the puncture needle 1 enters the right ventricle, fix the puncture needle 1, and send the puncture sheath 3 into the right ventricular cavity; then exit the puncture needle 1, and push the contrast agent through the puncture sheath 3 to confirm whether the puncture sheath 3 is in the right ventricle. Cavity (as shown in Figure 8);

Step S108: After clarifying that the stab sheath 3 is located in the right ventricular cavity, withdraw the right ventricular pigtail catheter; give the whole body heparinization, and send a 260cm long super-smooth guide wire through the stab sheath 3 into the right ventricular cavity, then adjust the position and send the guide wire Enter the pulmonary artery or across the tricuspid valve into the right atrium and superior vena cava (as shown in Figure 9);

Step S109: Feed the multifunctional catheter through the femoral vein, use a snare to wrap the distal end of the ultra-smooth guide wire, and pull it out of the body through the femoral vein to establish a femoral artery-femoral vein track (as shown in Figure 10);

Step S110: Ultrasonic assessment of whether the 260cm super-slip guide wire of the femoral artery-femoral vein orbit passes through the tricuspid chordae;

Step S111: After the guide wire passes through the chordae, the external part of the 260cm super-smooth guide wire, that is, the femoral artery and femoral vein are clamped with hemostatic forceps to prevent slipping off;

Step S112: After wiping with heparin saline wet gauze, the femoral artery-femoral vein vascular channel (as shown in FIG. 11) is ready for use.

3. Establishment of femoral artery-subclavian vein/jugular vein passage through cardiac ventricular septum;

The first 8 steps are the same as step S101 to step S108;

The multifunctional catheter is fed through the subclavian vein/jugular vein, the distal end of the ultra-smooth guide wire is sheathed in the pulmonary artery or superior vena cava with a snare, and pulled out through the subclavian vein/jugular vein to establish the femoral artery-subclavian vein /Jugular vein access (as shown in Figure 12);

Both ends of the femoral artery and subclavian vein/jugular vein are clamped with a hemostatic forceps to prevent slipping off; after wiping with heparin saline wet gauze, the track is ready for use.

4. Establishment of femoral vein-femoral vein track (as shown in Figure 14) through the cardiac ventricular septum;

After the femoral artery-femoral vein track is established, the multifunctional catheter is sent into the ascending aorta via the femoral vein-ventricular septum, and the snare is opened for use;

After puncturing the interatrial septum through the contralateral femoral vein, insert the interatrial septal puncture sheath into the left atrium, puncture the sheath through the interatrial septum, and insert a 5F pigtail catheter, guided by a 260cm ultra-smooth guide wire, across the mitral valve into the left Ventricular and ascending aorta;

In the ascending aorta, the snare is placed on the distal end of the 260cm ultra-smooth guide wire, then withdrawn and pulled out of the femoral vein to establish the femoral vein-femoral vein track; the entire track is: femoral vein-inferior vena cava-right atrium- Right ventricle-ventricular septum-left ventricle-left atrium-atrial septum-right atrium-inferior vena cava-contralateral femoral vein (as shown in Figure 13);

Both ends of the bilateral femoral veins are clamped with hemostatic forceps to prevent slippage; after wiping with heparin saline wet gauze, the track is used as a spare.

V. Pre-dilation of the cardiac ventricular septal puncture

Through the femoral vein, the 8.5F atrial septal puncture sheath 3 and the dilation tube are sent through the right ventricle across the ventricular septum into the left ventricle (as shown in Figure 15);

After withdrawing the puncture sheath 3 to expand the tube and vent, perform a left ventricular cavity angiography through the atrial septal puncture sheath 3 to determine the location of the puncture point in the interventricular septum (usually located in the middle of the ventricular septum, and different treatment methods have different requirements for the location of the puncture point , Depending on the situation);

The sheath 3 is punctured through the atrial septum, and a suitable balloon is sent across the interventricular septum, and then the puncture sheath 3 is withdrawn, and the balloon expands the heart ventricular septum. It should be noted that the pre-expansion or not and the diameter of the expanded balloon depend on the outer diameter of the catheter/sheath required for the next treatment. Generally, balloon expansion with a diameter of 8 mm can meet most needs. In the next step, the outer diameter of the treatment sheath is less than 9F, usually without pre-dilation.

Ultrasound evaluates the dilated interventricular septum. Usually, after a balloon with a diameter of 8 mm, there is no or only a small amount of left-to-right shunts at the ventricular level; these residual shunts usually close by themselves within 1 month.

The method provided by the present invention is mainly applied to pass through the ventricular septum of the heart. By establishing different types of vascular orbits, various cardiovascular catheters/sheaths are sent from the right ventricle into the left heart system (left ventricle, aorta or left atrium). Related diagnosis and treatment;

It can be applied to special atrial septal puncture, extra-heart tube puncture, puncture between large blood vessels (between vena cava and aorta), etc.;

Under special circumstances, it can be used to puncture other organs and tissues through the human body.

The above are the preferred embodiments of the present invention and the technical principles used by them. For those skilled in the art, without departing from the spirit and scope of the present invention, any technical solutions based on the present invention Obvious changes such as equivalent transformations and simple replacements fall within the protection scope of the present invention.

Claims

A puncture needle system for transcatheter heart ventricular septum puncture, characterized in that the puncture needle system includes a puncture needle made of nickel-titanium memory alloy and a puncture sheath in a hollow tube shape,

The lancet includes a tip and a tail. An operating handle is connected to the tail of the lancet. When the temperature of the lancet is higher than its temperature-increasing phase transition temperature, the tip of the lancet is smoothly curved and the hardness increases. When the temperature of the puncture needle is lower than its cooling phase transition temperature, the hardness of the puncture needle decreases;

The lancet sheath allows the lancet to penetrate freely, and is bent in a corresponding shape at a position corresponding to the tip of the lancet.
The lancet system for transcatheter heart ventricular septal puncture according to claim 1, wherein the operating handle and the tail of the lancet are detachably connected.
The lancet system for transcatheter cardiac septal puncture according to claim 2, wherein the operating handle includes a direction indicating label, and the direction indicated by the direction indicating label is consistent with the bending direction of the tip of the lancet Or present a fixed angle.
The puncture needle system for transcatheter cardiac ventricular septal puncture according to claim 1, wherein the bending angle of the tip of the puncture needle is any value between 30° and 90°.
The puncture needle system for transcatheter cardiac ventricular septal puncture according to claim 1, wherein the length of the curved section of the tip of the puncture needle is any value between 1 cm and 3 cm.
The puncture needle system for transcatheter cardiac ventricular septal puncture according to claim 1, wherein the temperature rise phase transition temperature of the puncture needle is any temperature range between 20°C and 35°C, and the cooling phase transition temperature is 0°C. Any temperature range between ℃ and 25℃.
The lancet system for transcatheter cardiac ventricular septal puncture according to any one of claims 1 to 7, wherein the lancet temperature is higher than the warming phase transition temperature, and its elastic modulus is 50 GPa to Any value between 100GPa, or

When the temperature of the lancet is lower than the cooling phase transition temperature, its elastic modulus is any value between 20 GPa and 60 GPa.
The puncture needle system for transcatheter heart ventricular septum puncture according to claim 1, wherein a ring mark is provided at one end of the lancet corresponding to the tip of the lancet, and the ring mark is X-ray Able to develop recognition.
The puncture needle system for transcatheter heart ventricular septum puncture according to claim 1, wherein the puncture sheath is located at one end of the puncture needle corresponding to the tip of the puncture needle, and the puncture sheath is gradually approached within a specific distance from the end. Taper tapered.
A method for transcatheter cardiac ventricular septal puncture implemented by the puncture system for transcatheter cardiac ventricular septal puncture according to any one of claims 1 to 9, characterized in that the method comprises:

Deliver the stab sheath into the left ventricle/right ventricle;

When the temperature of the lancet is lower than the cooling phase change temperature, the lancet is fed into the lancet sheath and the tip of the lancet does not protrude from the end of the lancet;

Let it stand for a certain period of time, so that the temperature of the lancet is higher than the temperature-increasing phase transition temperature, so that the tip of the lancet is smoothly curved;

After determining the puncture position, fix the puncture sheath and push the puncture needle through the interventricular septum into the right ventricle/left ventricle;

Fix the lancet and push the lancet sheath so that the lancet enters the right ventricle/left ventricle along the lancet;

Withdraw the lancet and keep the lancet for use.