CN111329558A

CN111329558A - Needle system and method for transcatheter ventricular septal puncture

Info

Publication number: CN111329558A
Application number: CN201910264938.7A
Authority: CN
Inventors: 闫朝武; 郝世杰
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-04-02
Filing date: 2019-04-02
Publication date: 2020-06-26

Abstract

The invention discloses a puncture needle system and a method for puncturing heart chambers through a catheter, wherein the puncture needle system comprises a puncture needle made of nickel-titanium memory alloy and a hollow tubular puncture sheath, and the puncture needle comprises a tip part and a tail part; an operating handle is connected with the tail part of the puncture needle, the tip part of the puncture needle is preset to be smoothly bent, so that when the temperature of the puncture needle is higher than the phase transition temperature of the puncture needle, the tip part of the puncture needle is smoothly bent and the hardness is increased, and when the temperature of the puncture needle is lower than the phase transition temperature of the puncture needle, the soft hardness of the puncture needle is reduced; the puncture sheath is used for the puncture needle to freely penetrate through and is bent in a corresponding shape at the position of the puncture sheath corresponding to the puncture needle tip. The invention utilizes the memory alloy to make the puncture needle, when the temperature of the puncture needle is higher than the phase transition temperature, the puncture needle automatically changes the hardness and the bending angle of the tip part, thereby being convenient for puncturing at room intervals.

Description

Needle system and method for transcatheter ventricular septal puncture

Technical Field

The present invention relates to a lancet system and method for transcatheter ventricular septal puncture.

Background

With the development of interventional procedures for left cardiac systems, particularly the development of new technologies such as transcatheter aortic valve implantation, transcatheter mitral valve repair/implantation, transcatheter left ventricular subintimal pacing, etc., it is important that a safe and effective approach is obtained through percutaneous transcatheter to the left cardiac system (mainly including aorta, left ventricle and left atrium). However, the current approach to the left heart system for clinical use has many disadvantages.

There are two main routes to percutaneous transcatheter access to the left cardiac system: (1) retrograde into the left cardiac system via the femoral or other peripheral arteries; (2) the interatrial septum is punctured by the femoral vein and advanced into the left cardiac system. However, both of these methods have serious limitations when a large sheath needs to be delivered. The former is limited by the caliber and the running of peripheral arteries, and the angle of entering the left heart system is too large, so that the conveying of a large sheath is not facilitated, and operation-related complications are greatly increased. The latter also faces the problem of too large an entry angle, leading to clinical failure. Therefore, there is a need for a novel apparatus and method to solve the above problems in clinical practice.

Accordingly, there is a need in the art for a new lancet system and method for transcatheter ventricular septal puncture that addresses the above-mentioned problems.

Disclosure of Invention

The invention aims to provide a puncture needle system and a puncture needle method for transfemoral ventricular septal puncture, which can effectively solve the problem of overlarge angle of entering a left ventricular system and facilitate the completion of ventricular septal puncture. To this end, in one aspect of the invention, a lancet system for transcatheter ventricular septal puncture is provided, the lancet system comprising a lancet made of nitinol and a hollow tubular sheath,

the puncture needle comprises a tip part and a tail part; the operating handle is connected with the tail part of the puncture needle, wherein the tip part of the puncture needle is smoothly bent and increased in hardness when the temperature of the puncture needle is higher than the temperature-rising phase-transition temperature of the puncture needle, and the hardness of the puncture needle is reduced when the temperature of the puncture needle is lower than the temperature-falling phase-transition temperature of the puncture needle;

the puncture sheath is freely penetrated by the puncture needle and is bent in a corresponding shape at the position of the puncture sheath corresponding to the puncture needle tip.

Further, the operating handle is detachably connected with the tail part of the puncture needle.

Further, the operation handle includes direction indication label, the direction that direction indication label instructed with the bending direction of stinging needle point portion is unanimous or is fixed contained angle.

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

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

Furthermore, the temperature-rising phase-change temperature of the felting needle is in any temperature interval between 20 ℃ and 35 ℃, and the temperature-lowering phase-change temperature is in any temperature interval between 0 ℃ and 25 ℃.

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

When the temperature of the puncture needle is lower than the temperature-reducing phase-change temperature, the elastic modulus of the puncture needle is any value between 20GPa and 60 GPa.

Further, an annular mark is arranged at one end of the puncture sheath corresponding to the puncture needle tip, and the annular mark can be visualized and identified under X-rays.

Further, at an end of the sheath corresponding to the lancet tip, the sheath is tapered within a certain distance gradually approaching the end.

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

delivering the sheath into the left/right ventricle;

when the temperature of the puncture needle is lower than the temperature-reducing phase-change temperature, the puncture needle is conveyed into the puncture sheath, and the tip of the puncture needle does not extend out of the end part of the puncture sheath;

standing for a certain time to enable the temperature of the pricking pin to be higher than the temperature-rising phase-transition temperature, and further enabling the tip of the pricking pin to be smoothly bent;

after the puncture position is determined, fixing the puncture sheath and pushing the puncture needle to pass through the ventricular septum and enter the right ventricle/left ventricle;

fixing the puncture needle and pushing the puncture sheath to enable the puncture sheath to enter the right ventricle/left ventricle along the puncture needle;

withdrawing the lancet and leaving the sheath ready for use.

The invention has the advantages that:

the invention provides a puncture needle system for puncturing heart chambers of a catheter, wherein a puncture needle is made of nickel-titanium memory alloy, the tip of the puncture needle is smoothly bent, when the temperature of the puncture needle is lower than the phase change temperature of the puncture needle, the puncture needle is wholly flexible and linear and is convenient to be matched with a puncture sheath to be sent into the heart chambers, and when the temperature of the puncture needle is higher than the phase change temperature, the tip of the puncture needle is smoothly bent, so that the rigidity of the puncture needle and the angle of the tip of the puncture needle in the heart chambers are effectively changed, and the puncture of the chambers is convenient to.

Further, the method for transcatheter ventricular septal puncture has ideal entry angle of the needle system, high success rate of the operation and greatly reduces the operation-related complications.

Drawings

FIG. 1 is a schematic view of a lancet structure in an embodiment of the present invention.

Fig. 2 is a schematic view of a sheath in an embodiment of the invention.

FIG. 3 is a schematic representation of the principal structure of a lancet system for transcatheter ventricular septal puncture in an embodiment of the present invention.

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

Fig. 5 is a schematic view of a puncture sheath in an embodiment of the invention being delivered to the middle of the left ventricle with a guidewire.

FIG. 6 is a schematic view of a lancet in an embodiment of the invention being threaded through a puncture sheath and into a left chamber.

FIG. 7 is a schematic view of the lancet tip puncturing chamber being partitioned from the left chamber to the right chamber in an embodiment of the present invention.

FIG. 8 is a schematic view of an embodiment of the present invention showing the state of the sheath secured after withdrawal of the lancet.

Fig. 9 is a schematic view of a long guidewire being fed from a sheath through the femoral artery into the right ventricular-pulmonary artery 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 view of a state in which large sheaths are fixed at both ends of the outside of the vascular track and are fed into the aorta through the femoral vein along the vascular track according to an embodiment of the present invention.

Fig. 12 is a schematic diagram illustrating a state of adjusting the retracted coarse sheath to a target position according to an embodiment of the present invention.

FIG. 13 is a schematic view of a right-atrial gross delivery sheath crossing the interventricular septum into the aorta via the femoral vein in an embodiment of the invention.

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

Fig. 15 is a schematic view of a large sheath crossing the interventricular septum into the left ventricle and left atrium along the vascular track through the femoral vein in an embodiment of the present invention.

Fig. 16 is a schematic orbital view of a subclavian vein-right ventricular-ventricular septum-left ventricular-femoral artery in an embodiment of the invention.

Fig. 17 is a schematic representation of a left ventricular subintimal pacing electrode implantation via the subclavian venous ventricular septal approach in an embodiment of the present invention.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings and examples.

Referring to fig. 1-3, a lancet system for transcatheter ventricular septal puncture is shown comprising a lancet 1 formed from a nitinol-based material, the lancet 1 including a tip portion 11 and a tail portion 12; an operating handle 2 is connected with the tail part 12 of the puncture needle 1; the lancet 1 is arranged such that the tip 11 of the lancet 1 is smoothly curved and increases in hardness when the lancet 1 is at a temperature above its temperature-increasing phase-change temperature, and the hardness of the lancet 1 decreases in a soft linear fashion when the lancet 1 is at a temperature below the temperature-decreasing phase-change temperature (as shown by the dashed lines in fig. 1). The puncture sheath 3 is hollow and tubular, and the puncture needle 1 freely penetrates through the puncture sheath, and the puncture sheath 3 is correspondingly bent in shape at the position corresponding to the tip 11 of the puncture needle 1.

In particular, the needle 1 made of nitinol can be either solid or hollow. The memory characteristic of the memory alloy is utilized, the tip 11 of the puncture needle 1 is set to be smoothly curved, and when the temperature of the puncture needle is lower than the temperature-reducing phase-change temperature, the puncture needle 1 is linear and soft as a whole and is convenient to be matched with the puncture sheath 3 to pass through an artery or a vein. Preferably, the lancet needle 1 has a temperature-raising phase-transition temperature in any temperature range between 20 ℃ and 35 ℃, for example, but not limited to, a temperature-raising phase-transition temperature of 20 ℃ to 25 ℃, 20 ℃ to 30 ℃, 20 ℃ to 35 ℃, 25 ℃ to 30 ℃, 22 ℃ to 30 ℃, 23 ℃ to 30 ℃, and the like. The temperature-lowering phase-change temperature of the lancet 1 is any temperature range between 0 ℃ and 25 ℃, for example, the temperature-lowering phase-change temperature is 0 ℃ to 25 ℃, 20 ℃ to 25 ℃, 15 ℃ to 20 ℃, etc., but not limited thereto. In this embodiment, the lancet 1 is configured to be entirely flexible and easily straightened when the temperature of the lancet 1 is less than 20 ℃; at temperatures above 30 c the lancet 1 has a smoothly curved tip 11 and an increased hardness. Namely, when the temperature of the puncture needle 1 is lower than 20 ℃, the puncture needle 1 is soft and has weaker hardness; when the temperature of the puncture needle 1 is higher than 30 ℃, the tip 11 of the puncture needle automatically bends at a fixed angle and the hardness is increased, thereby providing powerful support for puncture between chambers. That is, at the time of operation, when the lancet 1 is sent into the ventricle of the patient, the temperature of the tip 11 of the lancet 1 is made higher than the temperature-rising phase-transition temperature thereof by the body temperature of the patient, so that the puncture of the ventricular septum is facilitated by exhibiting a memory smooth curve accompanied by an increase in hardness. The lancet 1 can be, but is not limited to, 0.032 inch, 0.035 inch, 0.038 inch in diameter.

Further, by utilizing the shape memory property of the nitinol, the bending length 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, the bending length can be any value between 0.5cm and 3cm, and the specific length can be preset according to practical requirements. The distance between the tip 11 of the puncture needle 1 and the tip of the puncture needle 1 can be any value between 0cm and 3cm, namely the distance between the bent section and the tip can be any value between 0cm and 3cm, and the distance between the tip 11 and the tip can be preset according to actual requirements, and is preferably 0cm, 0.5cm, 1.5cm and 2 cm. The angle of curvature of the tip 11 of the lancet 1 is predetermined and can be anywhere from 30 ° to 90 °, preferably 45 ° to 60 °. The bending angle is an included angle (acute angle) between the corresponding tangent lines at the two ends (the starting point and the end point of the bending section) of the bending section. The bending angle can be correspondingly preset according to actual requirements.

When the temperature rises above the phase transition temperature, the hardness of the lancet 1 gradually increases with the temperature within a certain temperature range. When the temperature of the puncture needle 1 is lower than the temperature-reducing phase-change temperature, the hardness of the puncture needle gradually decreases along with the reduction of the temperature in a certain temperature range. In other words, the hardness of the lancet needle 1 changes accordingly with changes in temperature.

Further, the elastic modulus of the puncture needle 1 is between 50GPa and 100GPa when the temperature of the puncture needle 1 is higher than the temperature-rising phase-transition temperature, or between 20GPa and 60GPa when the temperature of the puncture needle 1 is lower than the temperature-falling phase-transition temperature. It should be noted that, for the same needle, the elastic modulus of the needle is higher than that of the needle at the temperature of temperature rise and phase change and is higher than that of the needle at the temperature of temperature drop and phase change.

Specifically, the lever 2 includes a direction indicating tab that indicates a direction that is aligned with or at a fixed angle (e.g., a 180 ° angle) to the direction of curvature of the tip 11 of the lancet 1, thereby facilitating identification and manipulation of the orientation of the tip 11. The handle 2 and the tail 12 of the lancet 1 can be detachably connected, fixedly connected or integrally formed. In use, the tip 11 of the lancet 1 can also be provided with a protective sheath to protect the lancet 1 and also to facilitate the feeding of the lancet 1 into the sheath 3.

Referring to fig. 2, fig. 2 schematically shows the main structure of the sheath, and as shown in fig. 2, an annular mark (not shown) is arranged at one end of the sheath 3 corresponding to the tip 11 of the puncture needle 1, and the annular mark can be visualized and identified under X-ray, so as to facilitate the positioning of the distance between the tip 11 of the puncture needle 1 and the outlet at the end of the sheath 3 during the operation. At the end of the sheath 3 corresponding to the tip 11 of the lancet 1, the sheath 3 tapers to a cone shape over a certain distance towards this end. In particular, there may be a gradual conical transition of anywhere between 0.1cm and 2cm, preferably 0.5cm, 1cm, 1.5cm, 2cm, near the end of the sheath 3, making the end exit sharp, facilitating the entry of the sheath 3 along the needle 1 across the ventricular septum myocardium into the ventricle.

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

Based on the above described lancet system for transcatheter ventricular septum puncture, the present invention also provides a method for transcatheter ventricular septum puncture. The method for transcatheter ventricular septal puncture provided by the present invention is described in detail below with reference to the accompanying drawings.

Referring to fig. 4, fig. 4 illustrates the main steps of a method for transcatheter ventricular septal puncture, as shown in fig. 4, the method comprising:

step S1: feeding the puncture sheath 3 into the left ventricle/right ventricle;

step S2: when the temperature of the puncture needle 1 is lower than the phase transition temperature, the puncture needle 1 is conveyed into the puncture sheath 3, and the tip 11 of the puncture needle 1 does not extend out of the end part of the puncture sheath 3;

step S3: standing for a certain time to enable the temperature of the pricking pin 1 to be higher than the phase transition temperature, and further enabling the tip of the pricking pin 1 to be smoothly bent;

step S4: after the puncture position is determined, the puncture sheath 3 is fixed and the puncture needle 1 is pushed to pass through the ventricular septum and enter the right ventricle/left ventricle;

step S5: fixing the puncture needle 1 and pushing the puncture sheath 3 to enable the puncture sheath 3 to enter the right ventricle/left ventricle along the puncture needle l;

step S6: the lancet 1 is withdrawn and the sheath 3 is left ready for use.

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

The conventional heart aortic valve surgery needs to be performed under general anesthesia and with surgical thoracotomy and extracorporeal circulation assistance, and related surgery risks are relatively high due to the highly invasive surgery.

Transcatheter mitral valve repair or replacement: after severe mitral insufficiency occurs, mitral valve repair or replacement is required, and mitral valve clamping or replacement through minimally invasive catheter intervention is receiving more and more attention at present besides traditional surgical open-chest surgery. During transcatheter intervention to treat the mitral valve, there are two main routes, namely transfixion into the left atrium via the femoral vein-atrial septum and transfixion into the left ventricle via the apex and then transmitral valve into the left atrium. The sheath tube of the former has an excessively large entry angle, which causes great interference to the operation and seriously restricts the size of the delivery instrument; the latter, as mentioned above, requires surgical assistance, resulting in increased surgical risks. Therefore, there is also a need for a new approach to overcome the limitations of current approaches in the clinic.

Transcatheter left ventricular endocardial pacing: in the implantation process of the cardiac pacemaker, the current clinical common method is right atrium and right ventricle pacing; however, the right ventricular pacemaker artificially causes the cardiac pacing sequence to change, and a complete left bundle branch conduction block is formed; this is potentially detrimental to left cardiac function in most patients; although the coronary sinus-coronary approach can solve the problem to some extent, it is still difficult to achieve some patients due to anatomical variation. Therefore, there is also a need for a new approach to overcome the limitations of current approaches in the clinic.

Based on the puncture system and the method for transfemoral ventricular septal puncture, a brand new way of entering a left heart system by crossing ventricular septal puncture through a femoral vein can be realized, namely, the ventricular septal puncture is realized by entering the left ventricle through the femoral artery through a brand new designed nickel-titanium alloy puncture needle and a puncture sheath matched with the puncture needle, a femoral artery-femoral vein track is established by a method of sleeving a long guide wire, and then the corresponding puncture sheath is conveyed from the femoral vein along the track to enter the left heart system. The method has various variations according to clinical requirements, including but not limited to: (1) femoral artery-ventricular septum-femoral vein track; (2) a femoral vein-interatrial septum-ventricular septum-femoral vein track providing an ideal vascular track for transcatheter mitral valve repair/replacement; (3) subclavian vein-ventricular septum-femoral artery track, vascular track for transcatheter left ventricular endocardial pacing, etc.

In more detail, the present invention provides a method for transcatheter ventricular septal puncture, which enables a safe and effective method to access the right ventricular cavity via the femoral artery in the left ventricular cavity puncture ventricular septal puncture, and then different vascular trajectories can be established according to different clinical requirements, mainly including but not limited to: (1) femoral artery-femoral vein tract including femoral artery-aorta-left ventricle-ventricular septum-right ventricle-right atrium-inferior vena cava-femoral vein (as shown in fig. 10). Through this trajectory, the femoral vein is passed through the ventricular septum into the aorta for transcatheter aortic valve implantation. (2) Femoral vein-femoral vein track, while puncturing the interatrial septum, the track comprising in sequence femoral vein-right atrium-interatrial septum-left atrium-left ventricle-ventricular septum-right ventricle-right atrium-femoral vein, providing an ideal track for transcatheter mitral valve repair/replacement (as shown in fig. 14); (3) subclavian vein-femoral artery tracks, including subclavian vein-superior vena cava-right atrium-right ventricle-ventricular septum-left ventricle-aorta-femoral artery (as shown in fig. 16), provide a track for transcatheter left ventricular endocardial pacing.

Based on the method for the transcatheter ventricular septal puncture provided by the invention, the success rate of the operation is high, the angle of the puncture sheath entering the ventricle is ideal, the channel can provide the optimal supporting force, and the operation related complications are greatly reduced.

Furthermore, the method for puncture through the catheter heart ventricular septum provided by the invention can puncture through the femoral artery left ventricular septum, and is favorable for accurate positioning and puncture of the ventricular septum.

Furthermore, the method for heart ventricular septal puncture through the catheter provided by the invention can establish different vascular tracks according to clinical requirements by entering the puncture chamber into the right ventricle cavity through the puncture sheath and combining the long guide wire and the snare after the puncture chamber enters the right ventricle at intervals, thereby providing a safe channel with excellent supporting force for subsequent treatment. Common vascular tracks include, but are not limited to, the femoral artery-femoral vein track, the femoral vein-femoral vein track, and the subclavian vein-femoral artery track.

Further, the method for transcatheter ventricular septal puncture provided by the present invention may further comprise delivering a balloon of suitable diameter to pre-expand the balloon at the ventricular septal puncture site along the established passageway via the femoral vein approach, thereby providing a smoother pathway for subsequent delivery of the large sheath through the passageway.

Further, the method for puncturing the transcatheter ventricular septum provided by the invention can also comprise the step of establishing a femoral vein-femoral vein track based on the puncture needle and the puncture sheath which are matched with the puncture ventricular septum and the atrial septum, so that a safe and excellent-supporting channel is provided for the mitral valve interventional therapy entering the left atrium through the femoral vein ventricular septum.

Further, the present invention provides a method for transcatheter ventricular septal puncture, further comprising: after puncture chamber spacing of the needle system, a long guide wire end is sleeved in an upper vena cava or a pulmonary artery through a subclavian vein feeding snare, so that a new track of subclavian vein-right atrium-right ventricle-ventricular septum-left ventricle-aorta-femoral artery is established, and a safe and effective channel is provided for implantation of a left ventricular endocardial pacing electrode through a subclavian vein-ventricular spacing approach (as shown in fig. 17).

The method for transcatheter ventricular septal puncture provided by the present invention is described in detail below with reference to specific embodiments.

Firstly, preoperative preparation:

disinfecting the two-side inguinal region; conventionally puncturing femoral artery and femoral vein for standby;

sending the blood into a pigtail catheter through a femoral artery to enter a left ventricle, sending the blood into a pigtail catheter through a femoral vein to enter a right ventricle, carrying out bilateral ventricular radiography at an interval tangent line position of the heart ventricle (the left anterior oblique position is optimal, the part of an outflow tract of the left ventricle at the interval of the anterior ventricle is fully displayed, and the puncture positioning is convenient), and evaluating the interval forms of the left ventricle, the right ventricle and the ventricle;

the puncture needle 1 is put into sterile frozen heparinized physiological saline for cooling for standby, and the puncture needle preset in the metal protective sleeve is soft and is favorable for being sent into the puncture sheath 3.

Secondly, heart ventricular septal puncture and ventricular septal femoral artery-femoral vein vascular track establishment:

step S101: the position of the pigtail catheter in the right chamber is kept unchanged, so that the pigtail catheter is convenient to reference and position during puncture; entering the middle of the left ventricle through the femoral artery exchange sheath (as shown in fig. 5);

step S102: the sterile frozen heparinized physiological saline exhausts air and fills the inner part of the puncture sheath body; then quickly sending the puncture needle 1 cooled by ice water into the puncture sheath 3, wherein the tip part 11 of the puncture needle 1 is close to the opening at the far end of the puncture sheath 3, but the tip part does not have an annular mark of the puncture sheath 3, so as to ensure that the tip part 11 is positioned in the puncture sheath 3;

step S103: the puncture needle 1/puncture sheath 3 is placed in the left chamber for about 10-20 seconds, and the tip 11 of the puncture needle 1 automatically bends and forms with the rising temperature, and the hardness rapidly increases; rotating the handle 2 of the tail 12 of the lancet 1 such that the distal end of the bent lancet 1/sheath 3 is directed vertically towards the middle of the interventricular septum (as shown in fig. 6);

step S104: perspective and ultrasonic positioning are carried out, and the position of the far end of the puncture needle 1/puncture sheath 3 on the left ventricular surface of the ventricular septum is further confirmed;

step S105: after the proper puncture position is confirmed, the puncture sheath 3 is fixed and the puncture needle 1 is pushed, the puncture needle obliquely runs for 30-90 degrees and penetrates through the middle ventricular septum (muscular part) of the left ventricle to enter the cavity of the right ventricle (as shown in fig. 7), and the puncture depth refers to preoperative radiography;

step S106: the ultrasonic wave determines whether the far end of the puncture needle 1 enters the cavity of the right chamber, so as to prevent the puncture from insufficient puncture and not passing through the ventricular space or the puncture from excessively damaging the wall of the right chamber or other tissues;

step S107: after the puncture needle 1 is confirmed to enter the right chamber, the puncture needle 1 is fixed, and the puncture sheath 3 is sent into the right chamber cavity; then the puncture needle 1 is withdrawn, and after air is exhausted, contrast agent is pushed by the puncture sheath 3 to determine whether the puncture sheath 3 is in the right chamber (as shown in fig. 8);

step S108: clearly withdrawing the right-ventricular pigtail catheter after the puncture sheath 3 is positioned in the right-ventricular cavity; heparinization is carried out on the whole body, a 260cm long ultra-smooth guide wire is sent into the right ventricular cavity through the puncture sheath 3, then the position is adjusted, and the guide wire is sent into the pulmonary artery or crosses the tricuspid valve to be sent into the right atrium and the superior vena cava (shown in figure 9);

step S109: delivering a multifunctional catheter through the femoral vein, using a snare to sleeve the far end of the ultra-smooth guide wire, and pulling out the ultra-smooth guide wire from the body through the femoral vein to establish a femoral artery-femoral vein track (as shown in figure 10);

step S110: ultrasonically evaluating whether a 260cm ultra-smooth guidewire of a femoral artery-femoral vein track passes through the tricuspid chordae tendineae;

step S111: after the external guide wire passes through the chordae tendineae, the external part of the 260cm ultra-smooth guide wire, namely the two ends of the femoral artery and the femoral vein, are clamped by hemostatic forceps to prevent slipping;

step S112: after the wet gauze with heparin saline, the femoral artery-femoral vein passage (as shown in fig. 11) was ready for use.

Thirdly, establishing a femoral artery-subclavian vein/jugular vein channel by heart ventricle separation;

the first 8 steps are synchronous steps S101 to S108;

delivering the multifunctional catheter through the subclavian vein/jugular vein, sheathing the far end of the ultra-smooth guide wire on the pulmonary artery or the superior vena cava by using a snare, and pulling out of the body through the subclavian vein/jugular vein to establish a femoral artery-subclavian vein/jugular vein channel (as shown in figure 12);

the two ends of the femoral artery and the subclavian vein/jugular vein are clamped by hemostatic forceps to prevent slipping; after the heparin saline wet gauze is wiped, the track is reserved.

Fourthly, establishing a transforaminal septal femoral vein-femoral vein orbit (as shown in figure 14);

after a femoral artery-femoral vein track is established, the multifunctional catheter is sent into an ascending aorta through a femoral vein-ventricular interval, and a snare is opened for standby application;

after puncturing the interatrial septum through the contralateral femoral vein, the interatrial septum puncture sheath is arranged in the left atrium, the interatrial septum puncture sheath is sent into a 5F pigtail catheter, and the catheter crosses over the mitral valve to enter the left ventricle and ascending aorta under the guide assistance of a 260cm ultra-smooth guide wire;

sleeving the distal end of the 260cm ultra-smooth guide wire by a snare in the ascending aorta, withdrawing the snare and pulling the snare out of the body from the femoral vein, and establishing a femoral vein-femoral vein track; the whole process of the track is as follows: femoral vein-inferior vena cava-right atrium-right ventricle-interventricular septum-left ventricle-left atrium-interatrial septum-right atrium-inferior vena cava-contralateral femoral vein (as shown in fig. 13);

the two ends of the femoral vein at the two sides are clamped by hemostatic forceps to prevent slipping; after the heparin saline wet gauze is wiped, the track is reserved.

Fifthly, pre-expansion of puncture position of heart ventricular septum

By the femoral vein route, the 8.5F interatrial septum puncture sheath 3 is delivered and the dilation tube is passed across the interventricular septum via the right ventricle into the left ventricle (as shown in FIG. 15);

after the puncture sheath 3 dilation tube is withdrawn and exhausted, the puncture sheath 3 is punctured through the interatrial septum to carry out left ventricular cavity radiography, and the position of the puncture point in the interventricular septum is determined (usually, the puncture point is positioned in the middle of the interventricular septum, and different treatment methods have different requirements on the position of the puncture point and are determined according to the situation);

the sheath 3 is punctured through the atrial septum, a suitable balloon is fed across the interventricular septum, and then the puncture sheath 3 is withdrawn and the balloon expands the interventricular septum. It should be noted that the pre-expansion or not and the diameter of the expansion balloon depend on the outer diameter of the catheter/sheath needed for the next treatment, and the expansion of the balloon with a diameter of 8mm can meet most requirements. Whereas the next treatment sheath, with an outside diameter < 9F, usually does not require pre-dilation.

Ultrasound assessment of the ventricular septum after expansion, typically 8mm diameter balloon expansion, with no or only a small left-to-right shunt at the ventricular level; these residual shunts typically self-close within 1 month.

The method provided by the invention is mainly applied to crossing the heart ventricular septum, sending various cardiovascular catheters/sheaths from the right ventricle to the left heart system (left ventricle, aorta or left atrium) by establishing different types of vascular tracks, and carrying out related diagnosis and treatment;

can be applied to puncture of special interatrial septum, puncture of extra-cardiac conduit, puncture of large blood vessels (such as between inferior vena cava and aorta), and the like;

in special cases, the puncture needle can be applied to puncture of other organs and tissues through a human body pipeline.

The above description is of the preferred embodiment of the present invention and the technical principles applied thereto, and it will be apparent to those skilled in the art that any changes and modifications based on the equivalent changes and simple substitutions of the technical solution of the present invention are within the protection scope of the present invention without departing from the spirit and scope of the present invention.

Claims

1. A lancet system for transcatheter ventricular septal puncture, characterized in that the lancet system comprises a lancet made of a nickel-titanium memory alloy and a hollow tubular sheath,

the pricking pin comprises a tip part and a tail part, and an operating handle is connected with the tail part of the pricking pin, wherein when the temperature of the pricking pin is higher than the temperature-rising phase-transition temperature of the pricking pin, the tip part of the pricking pin is smoothly bent and the hardness of the pricking pin is increased, and when the temperature of the pricking pin is lower than the temperature-falling phase-transition temperature of the pricking pin, the hardness of the pricking pin is reduced;

2. A lancet system for transcatheter ventricular septum penetration according to claim 1, wherein the handle is removably attached to the tail of the lancet.

3. A lancet system for transcatheter ventricular septum penetration according to claim 2, wherein the handle comprises a direction indicating label indicating a direction that is consistent with or at a fixed angle to a direction of curvature of the lancet tip.

4. A lancet system for transcatheter ventricular septum penetration according to claim 1, wherein the bending angle of the lancet tip is any value between 30 ° and 90 °.

5. A lancet system for transcatheter ventricular septum penetration according to claim 1, wherein the curved section of the lancet tip has a length of any one of between 1cm and 3 cm.

6. A lancet system for transcatheter ventricular septum puncture according to claim 1, wherein the lancet has a warming phase transition temperature in any temperature interval between 20 ℃ and 35 ℃ and a cooling phase transition temperature in any temperature interval between 0 ℃ and 25 ℃.

7. A lancet system for transcatheter ventricular septum puncture according to any one of claims 1 to 7, wherein the lancet temperature is above the warming phase transition temperature with an elastic modulus of any value between 50GPa and 100GPa, or

8. A lancet system for transcatheter ventricular septum puncture according to claim 1, wherein an annular marker is provided at an end of the sheath corresponding to the lancet tip, the annular marker being visually identifiable under X-ray.

9. A lancet system for transcatheter ventricular septum penetration according to claim 1, wherein at an end of the sheath corresponding to the lancet tip, the sheath tapers to a cone shape for a specified distance proximal to the end.

10. A method for transcatheter ventricular septal puncture implemented by a puncture system for transcatheter ventricular septal puncture according to any one of claims 1-9, the method comprising:

delivering the sheath into the left/right ventricle;

withdrawing the lancet and leaving the sheath ready for use.