CN110339433B

CN110339433B - Triple puncture needle device and method for transthoracic epicardial intramyocardial injection under ultrasonic guidance

Info

Publication number: CN110339433B
Application number: CN201910767141.9A
Authority: CN
Inventors: 曹丰; 刘丽文; 李苏雷; 刘峻松; 陶博
Original assignee: Chinese PLA General Hospital
Current assignee: Chinese PLA General Hospital
Priority date: 2019-08-20
Filing date: 2019-08-20
Publication date: 2024-05-14
Anticipated expiration: 2039-08-20
Also published as: WO2021031617A1; CN110339433A

Abstract

A triple needle device for transthoracic epicardial endocardial injection under ultrasound guidance, comprising: a coarse puncture needle, a fine puncture needle core and an extension hose; the thin puncture needle is inserted into the thick puncture needle; the thin puncture needle core is inserted into the thin puncture needle; during injection, the fine puncture needle core is withdrawn from the fine puncture needle; the end seat of the extension hose is combined on the base of the thin puncture needle, so that the thin puncture needle is communicated with the extension hose. Through the device, the medicine can be injected into the cardiac muscle through the thoracoepicardium through the puncture needle under the guidance of ultrasound by only puncturing 2-3 holes on the chest wall of a subject each time, and the device has the advantages of high local medicine administration concentration, accurate and controllable injection position, small wound, less complications, multiple medicine administration at different time points and the like. Meanwhile, the risk of direct damage to myocardial tissues and damage to epicardial blood vessels of the puncture needle is reduced to the greatest extent, the problem of continuous beating of the heart is overcome to a certain extent, and the administration is accurate, so that secondary damage to the myocardium is avoided.

Description

Triple puncture needle device and method for transthoracic epicardial intramyocardial injection under ultrasonic guidance

Technical Field

The application relates to a technology of intramyocardial injection, in particular to a triple puncture needle device and a method for transthoracic epicardial intramyocardial injection under ultrasonic guidance.

Background

Cardiovascular diseases account for about 25% of all human causes of death, and various cardiovascular diseases can lead to heart failure such as myocardial infarction, heart valve disease, cardiomyopathy, hypertension, etc. The incidence rate of heart failure of adults is 1-2% in European and American countries and 0.9-1.3% in China, and the incidence rate is on the rising trend. For heart failure patients, even if the primary cause is corrected, since most of the cardiomyocytes are in a terminally differentiated state, the cells lack self-regeneration ability, and are difficult to regenerate once necrotic, so that the heart function deterioration is difficult to reverse, the death rate is high, and medical resources are consumed in a large amount. The current treatment methods for improving left ventricular remodeling besides drug therapy also comprise heart resynchronization therapy, left ventricular assist devices, heart transplantation and the like, but have respective limitations. Currently, the long-term prognosis of heart failure patients is not optimistic, and the survival rate of heart failure patients is less than 50% 5 years after the first onset of heart failure, which is equivalent to malignant tumors.

In recent years, biological treatment represented by stem cells, cytokines and the like brings hopes for heart failure patients, and the treatment method has the potential of directly repairing damaged cardiac muscle and has great social application value. In animal experiments and clinical experiments related to scientific research, the administration of the medicine by intracardiac and epicardial myocardial injection through a catheter is mainly carried out through peripheral veins and coronary arteries at present. Wherein, the medicine enters the local cardiac muscle through blood circulation by peripheral vein and coronary artery, so that the local blood concentration of the damaged cardiac muscle is low and the effect is poor. Special surgical instruments are needed for transendocardial drug delivery through a catheter, the cost is high, and a catheter puncture needle is difficult to accurately position in a three-dimensional heart cavity, so that the surgical difficulty and the cost are further increased through electrophysiology system mapping, and the practical application is affected. While the open chest epicardial intramyocardial injection way has high local blood concentration of damaged cardiac muscle, but has large open chest trauma and high anesthesia risk, directly destroys the pericardial structure, further reduces the intervention effect by postoperative scar adhesion, is difficult to clinically apply, and is more used for patients originally planning open chest surgery. Therefore, the method for exploring the path and the method which are small in wound, can accurately position the local myocardial tissue requiring intervention and have high drug administration efficiency has strong scientific research and clinical application values.

The current spatial resolution of high-resolution ultrasound is close to that of magnetic resonance imaging, and high-quality images enable the clinical application of ultrasound guided puncture to be increased, so that the high-resolution ultrasound is widely developed in various diseases such as liver tumor, thyroid nodule and the like. Since the heart is a continuously beating organ, and ultrasound has the characteristic of high time resolution, ultrasound has unique advantages in the field of cardiac imaging. We find in the early animal experiments that the heart muscle tissue is punctured by an epicardial puncture needle (18G, with an outer diameter of 1.2 mm) under open chest direct vision, so long as the blood vessel is not directly damaged and the wall of the heart is penetrated, the local heart muscle only has a small amount of blood seepage, and animal vital signs are stable during operation and after operation, and no obvious complications exist. There are also small sample clinical studies to prove that, aiming at hypertrophic obstruction type cardiomyopathy patients, radio frequency ablation is performed at intervals of the apex puncture room under the guidance of ultrasound, the incidence rate of postoperative pericardium filling is very low, and if necessary, the drainage can be conveniently carried out by tube placement, the safety of the patients is ensured, and the clinical feasibility of epicardial myocardial puncture is prompted.

Coronary arteries and veins are epicardially distributed, and once damaged during the puncture process, acute pericardial tamponade may be life threatening. And the heart continuously beats, which has great influence on the accurate control of the administration position of puncture injection. The conventionally used puncture needle is an inclined plane puncture needle with a matched needle core, the needle body is in strong echo under ultrasound, and the puncture of various organ tissues can be completed under the ultrasound guidance. The thick puncture needle, such as the 18G puncture needle with the outer diameter of 1.2mm, is more beneficial to penetrate superficial hard tissues and establish a stable channel in tissues of surrounding bony structures, such as the chest wall, and has stronger echo under ultrasound, but the risk of damaging deep tissues, especially important tissues, is higher, such as the risk of damaging epicardial blood vessels when the myocardium is punctured by the transthoracic epicardium, and the direct damage to local myocardial tissues is also higher. A thin puncture needle, such as a 22G or 25G puncture needle, has the outer diameters of 0.7mm and 0.5mm respectively, is soft, is not easy to penetrate the chest wall, and has relatively weak ultrasonic echo, but the risk of damaging coronary vessels and local cardiac muscles is greatly reduced, especially when multiple puncture is performed.

Disclosure of Invention

In view of the above problems, the present application aims to provide a puncture needle device capable of performing intramyocardial injection via the epicardium under ultrasound guidance, which can directly administer and inject to the myocardium. The application also aims to provide a method for injecting cardiac muscle through chest epicardium under ultrasonic guidance.

The triple puncture needle device of the present application is used for intramyocardial injection through the epicardium under ultrasonic guidance, and comprises: a coarse puncture needle, a fine puncture needle core and an extension hose;

the thick puncture needle comprises a first tube body, wherein the first end of the first tube body is a tip comprising an inclined plane, and the second end of the first tube body is a base; the thick puncture needle is used for puncturing the chest wall;

The thin puncture needle comprises a second tube body, the first end of the second tube body is a tip end comprising an inclined plane, and the second end is a base; the length of the thin puncture needle is longer than that of the thick puncture needle; the fine puncture needle is used for puncturing cardiac muscle and providing medicines for cardiac muscle;

The thin puncture needle core is solid, the first end is a tip comprising an inclined plane, and the second end is a base;

The first end of the extension hose comprises an end seat, and the second end of the extension hose is used for connecting a device;

The second tube body of the thin puncture needle can be inserted into the first tube body of the thick puncture needle in a withdrawn mode;

during the puncturing process, the thin puncture needle core is inserted into the second tube body;

During the injection, the thin needle core is withdrawn from the second tube; the end seat of the extension hose is combined on the base of the second pipe body, so that the second pipe body is communicated with the extension hose.

Preferably, during the puncturing process, when the chest wall is punctured, the first end of the first tube body, the first end of the second tube body and the first end of the thin puncture needle core are aligned to form a flat inclined plane; when the cardiac muscle is punctured, the first end of the second tube body is aligned with the first end of the fine puncture needle core and extends out from the first end of the first tube body.

Preferably, when the second tube body of the thin puncture needle is inserted into the first tube body of the thick puncture needle, the second tube body and the first tube body are airtight;

The thin needle core is airtight with the second tube when the thin needle core is inserted into the second tube.

Preferably, a scale is arranged on the outer side of the first tube body so as to confirm the needle penetration depth of the coarse puncture needle;

graduations are provided on the outer side of the second tube body to confirm the needle insertion depth of the fine puncture needle.

Preferably, an annular mark is provided on the outside of the second body, the first end of the second body being aligned with the first end of the first body when the annular mark is aligned with the second end of the first body;

A notch is formed on the second end of the base of the second pipe body; a protrusion is formed on a first end of the base of the thin lancet core; the protrusion can be clamped into the notch to align the first end of the second tube body with the first end of the fine puncture needle core.

Preferably, the tip of the first end of the second tube is adapted to penetrate the anterior and anterior walls of the short axis of the left ventricle, or the inferior and posterior walls of the left ventricle.

Preferably, the first end of the thin needle penetrates into the myocardium to a depth of 1-5cm;

drug injection is performed when the first end of the thin needle is located in the myocardium in the endocardium and epicardium, and the distance D1 from the endocardium and the distance D2 from the epicardium are both greater than 2mm during diastole.

Preferably, the angle between the line connecting the epicardial puncture point and the short axis centerline of the left ventricle and the thin puncture needle is 120 ° -150 °.

The application relates to a method for injecting transthoracic epicardial intramyocardial under ultrasonic guidance, which utilizes the triple puncture needle device to inject;

performing chest wall puncture with the thin puncture needle inserted into the thick puncture needle and the thin puncture needle inserted into the thin puncture needle, and with the first ends of the thick puncture needle, the thin puncture needle and the thin puncture needle inserted into the thin puncture needle aligned;

after the chest wall puncture is finished, the thin puncture needle and the needle core of the thin puncture needle extend beyond the first end of the thick puncture needle, proper epicardial puncture points are selected, and the heart muscle of the left ventricle is punctured to a preset depth at a preset angle, so that the heart muscle puncture is finished;

Removing the thin puncture needle core, connecting the extension hose to the second end of the thin puncture needle, so that the medicine enters the cardiac muscle through the extension hose and the thin puncture needle;

Reinserting the fine puncture needle core into the fine puncture needle, and pushing the medicine remained in the fine puncture needle into cardiac muscle;

after the administration is completed, the thin puncture needle is retracted into the thick puncture needle, the pericardial effusion is observed by ultrasound, the blood circulation is stable, and then the thin puncture needle and the thick puncture needle are withdrawn from the chest wall together, so that the skin opening is sealed.

Preferably, the included angle between the line connecting the epicardial puncture point and the short axis center line of the left ventricle and the thin puncture needle is 120-150 degrees;

the depth of the first end of the thin puncture needle into the cardiac muscle is 1 cm to 5cm;

The puncture needle device and the method under ultrasonic guidance can be used for transthoracic epicardial intramyocardial injection, and can inject the medicine into the cardiac muscle through the puncture needle through the epicardial by only puncturing 2-3 holes (each hole has the diameter of about 1 mm) on the chest wall of a subject each time under the ultrasonic guidance, and the device and the method have the advantages of high local medicine administration concentration, accurate and controllable injection position, small trauma, less complications, multiple medicine administration at different time points and the like. The injection administration is effectively completed, the risk of direct damage of the puncture needle to myocardial tissues and damage to epicardial blood vessels is reduced to the greatest extent, the problem of continuous beating of the heart is overcome to a certain extent, the administration is accurate, and the secondary damage of the myocardium is avoided. The device and the method provide a convenient, safe and efficient intramyocardial administration mode, can also be used for injection administration of other deep tissues, reduce deep important tissue injury, and have strong clinical transformation value.

Drawings

FIG. 1 is a schematic cross-sectional view of the components of the triple puncture needle device of the present application;

FIG. 2 is a schematic view of the triple puncture needle of the present application when performing chest wall puncture;

FIG. 3 is a schematic view of the triple puncture needle of the present application when performing myocardial puncture;

FIG. 4 is a schematic view of the triple puncture needle of the present application for drug injection;

FIG. 5 is a schematic diagram of the combination of an ultrasonic diagnostic apparatus, an ultrasonic probe, and a corresponding puncture frame and puncture needle;

FIG. 6 is a schematic diagram of the distribution of the needle tip in the myocardium (blue region);

FIG. 7 is a schematic view of the angle α between the thin needle and epicardial puncture point and the center line of the short axis of the left ventricle;

FIG. 8 is a schematic view of an intramyocardial injection site, D1 being the distance of the needle tip from the endocardial layer and D2 being the distance of the needle tip from the epicardial layer;

FIG. 9 is a schematic illustration of transthoracic epicardial drug injection under ultrasound guidance to porcine myocardium;

FIG. 10 is a schematic illustration of the injection of drugs into the myocardium of a pig transthoracic epicardially under ultrasound guidance and after injection;

FIG. 11 is a graph showing the contrast before and after injection of a drug into the myocardium of a pig via the chest epicardium under ultrasound guidance;

fig. 12 is an image of a puncture site after an animal operation.

Detailed Description

The present application will be described in detail with reference to the accompanying drawings.

the thick puncture needle comprises a first tube body 10, wherein the first end 12 of the first tube body is a tip end, and the second end is a base 11; the rough puncture needle is used for puncturing the chest wall.

The thin puncture needle comprises a second tube body 20, a first end 22 of the second tube body is a tip, and a second end is a base 21; the length of the thin puncture needle is longer than that of the thick puncture needle; the fine puncture needle is used to puncture the heart muscle and provide medicine to the heart muscle.

The fine puncture needle core 30 is solid, with a tip at a first end 32 and a base at a second end 31.

The first end of the extension hose 40 comprises an end socket 41 and the second end of the extension hose 40 is used for a connection means, such as a syringe. When connected to the syringe, a fitting 42 may be provided at the second end of the extension hose 40 for connection to the nipple of the syringe.

The second tube 20 of the thin needle is insertably withdrawn into the first tube 10 of the thick needle.

During the puncturing process, the fine puncturing needle core 30 is inserted into the second tube body 20.

During injection, the fine puncture needle core 30 is withdrawn from the second tube 20; the end seat 41 of the extension hose 40 is coupled to the base 21 of the second tube body such that the second tube body 20 communicates with the extension hose 40. Specifically, the end seat 41 is tightly coupled in the recess 23 of the second end of the base 21 such that the extension hose 40 communicates with the second tube body 20.

In the process of puncturing, when the chest wall is punctured, the first end 12 of the first tube body 10, the first end 22 of the second tube body 20 and the first end 21 of the thin puncture needle core 30 are aligned to form a flat inclined plane, as shown in fig. 2; upon penetration of the myocardium, the first end 22 of the second tube 20 and the first end 32 of the thin puncture needle core 30 are aligned and extend from the first end 12 of the first tube 10, as shown in FIG. 3.

When the second tube body 20 of the thin puncture needle is inserted into the first tube body 10 of the thick puncture needle, the second tube body 20 and the first tube body 10 are airtight; the airtight may be achieved by close contact between the second tube 20 and the first tube 10, or may be achieved by providing a sealing ring between the second tube 20 and the first tube 10.

Similarly, when the fine puncture needle core 30 is inserted into the second tube body 20, the fine puncture needle core 30 and the second tube body 20 are airtight; the air-tightness can be achieved by the close contact between the second tube body 20 and the fine puncture needle core 30, or can be achieved by providing a sealing ring between the second tube body 20 and the fine puncture needle core 30.

Graduations are provided on the outside of the first tube body 10 so as to confirm the needle penetration depth of the rough puncture needle.

Graduations are provided on the outside of the second tube 20 to confirm the needle insertion depth of the fine puncture needle.

An annular mark is provided on the outside of the second tube 20, the first end of which is aligned with the first end of the first tube when the annular mark is aligned with the second end of the first tube.

A recess is formed at a second end of the base 21 of the second tube 20; a protrusion is formed on a first end of the base 31 of the fine puncture needle core 30; the protrusion can be clamped into the notch to align the first end of the second tube body with the first end of the fine puncture needle core.

The tip of the first end 22 of the second tube 20 is adapted to penetrate the anterior and lateral short axis walls of the left ventricle, or the inferior posterior wall of the left ventricle.

The depth of the first end of the thin puncture needle into the cardiac muscle is 1 cm to 5cm; drug injection is performed when the first end of the thin needle is located in the myocardium in the endocardium and epicardium, and the distance D1 from the endocardium and the distance D2 from the epicardium are both greater than 2mm during diastole.

The included angle between the connecting line of the epicardial puncture point and the short axis center line of the left ventricle and the thin puncture needle is 120-150 degrees.

Performing chest wall puncture with the thin puncture needle inserted into the thick puncture needle and the thin puncture needle inserted into the thin puncture needle, wherein the first ends of the thick puncture needle, the thin puncture needle and the thin puncture needle are aligned;

After the chest wall puncture is finished, the thin puncture needle and the needle core of the thin puncture needle extend beyond the first end of the thick puncture needle, proper puncture points are selected, and the heart muscle is punctured to a preset depth of heart muscle of the left ventricle at a preset angle, so that the heart muscle puncture is finished;

The thick puncture needle is a tubular needle, the surface of the thick puncture needle is provided with scales, the needle tip or the tip is inclined, the inner diameter is the same as the outer diameter of the thin puncture needle, namely, the thickness of the tube wall is increased on the basis of the conventional puncture needle, and various specifications such as design according to the requirements of other puncture parts can be realized. The length of the thick puncture needle is sufficient to penetrate the shallow hard tissue, such as the chest wall.

The needle points or the tips of the fine puncture needle and the fine puncture needle core are inclined planes, and a common inclined plane is formed between the tip and the needle point of the coarse puncture needle, so that the puncture is facilitated; the length is consistent, and the outer diameter of the needle core is approximately equal to the inner diameter of the thin puncture needle; the direction of the thin puncture needle is kept consistent with that of the needle core through the buckling of the protrusion at the tail end of the needle core and the groove at the tail end interface of the thin puncture needle. The needle tips of the thick puncture needle and the thin puncture needle are kept flush, an annular mark is arranged at the position of the thin puncture needle body, which is consistent with the length of the thick puncture needle, a part of the thick puncture needle is grown, a linear mark is arranged at the position of the needle body central line corresponding to the groove at the tail end of the thin puncture needle, and scales are marked, so that the relative position and the actual needle penetration depth of the thick/thin puncture needle during the puncture operation can be conveniently mastered. The thin puncture needle is longer than the thick puncture needle, can meet the requirement of intramyocardial injection, and can be designed into different length specifications according to application requirements. After the thin puncture needle is in place, the needle core is withdrawn. The tail end of the thin puncture needle is provided with an interface, which is convenient for connecting the extension hose.

One end of the extension hose is connected with the thin puncture needle, and the other end is connected with the injector for administration. The hand only fixes and prolongs one end of the hose connected with the injector during injection, so that the thin puncture needle has a certain range of movement along with deep tissues, and secondary damage is reduced.

Although fig. 1-4 show the case that the thick puncture needle, the thin puncture needle and the thin puncture needle core are inclined when aligned, the application is not limited to the needle tip form, as long as the three are assembled to facilitate puncture, and any form of tip is possible.

The specific using method is as follows:

(1) The chest wall puncture needle is completed under the conventional ultrasonic guidance, and the needle is inserted at the upper edge of the next rib, so as to avoid intercostal blood vessels and nerves. The puncture frame matched with the ultrasonic probe is used for locking a puncture needle (shown in figure 5), the section is selected to be horizontal to the short axis apex of the left ventricle or horizontal in the ventricle, the position is mainly positioned on the front wall and the front side wall of the short axis of the left ventricle (shown in figure 6), the lower rear wall can also be selected, and the puncture path avoids the anterior interventricular sulcus opposite to the ventricular septum space so as to avoid directly damaging the anterior descending branch. The short axis surface of the left ventricle of the heart is displayed by an ultrasonic diagnostic apparatus, the probe is adjusted, the epicardial puncture point is determined by a puncture guide wire carried by the apparatus, the needle insertion depth is determined according to the treatment requirement, and the injection administration position is selected under the condition that the needle point is completely visible under the ultrasonic.

(2) The triple puncture needle forms a whole before puncturing, keeps the tip flush (as shown in figure 2), punctures the chest wall, has breakthrough sense, and is fixed before puncturing the pericardium and the cardiac muscle. The needle track position for further penetration of the myocardium is determined using the ultrasound-carried guide wire. The thin puncture needle and the needle core are further pushed, and the needle insertion depth is judged by the scale marks. The electrocardiographic monitoring can generate ventricular premature beat when the fine puncture needle just penetrates into the cardiac muscle, and can be used as auxiliary judgment. After the injection position is selected (as shown in figure 3), the fine puncture needle core is withdrawn, the extension hose is connected (as shown in figure 4), and the hand only fixes one end of the extension hose connected with the injector during injection, so that the fine puncture needle has a certain range of movement along with deep tissues such as heart and the like, and secondary damage is reduced. The thin puncture needle is gradually retracted, and intermittent injection administration is performed in the retracting process, so that the multipoint administration of a single needle track can be completed. After the administration is completed, the thin puncture needle is retracted into the thick puncture needle, the pericardial effusion is observed by ultrasound, the blood circulation is stable, and then the thin puncture needle and the thick puncture needle are withdrawn from the chest wall together, so that the skin opening is sealed.

(3) The short axis surface of the left ventricle of the heart is displayed by the ultrasonic diagnostic apparatus, the puncture needle is controlled to avoid needle insertion parallel to the contraction direction of the cardiac muscle on the short axis, and the risk of penetrating the wall of the chamber is reduced. The position of the puncture needle entering the epicardium is an epicardium puncture point, and the position of the puncture needle entering the myocardium and being administered is an intramyocardial injection point. The specific angle can be calculated through the puncture guide wire of the instrument, the included angle alpha between the puncture needle and the epicardial puncture point and the central line of the short axis of the left ventricle, the size of alpha is adjusted through changing the position of the ultrasonic probe and selecting the puncture guide wire with different angles, and the needle can be punctured when the thickness factor of the chamber wall is more than or equal to 120 degrees and less than or equal to 150 degrees (as shown in figure 7). At this time, the puncture can ensure that the travel distance of the puncture needle in the cardiac muscle is long, and the risk of penetrating the ventricular wall is reduced to the greatest extent.

(4) The thin puncture needle and the needle core are further pushed, and the needle insertion depth is judged by the scale marks. Pushing the fine puncture needle into the cardiac muscle for 1 cm to 5cm. Electrocardiogram monitoring can generate ventricular premature beat when the fine needle just penetrates into the cardiac muscle, and can be used as auxiliary judgment. The injection position is selected, the distance between the needle tip and the inner membrane and the outer membrane of the ventricle is ensured to be more than 2mm under the ultrasonic guidance, the safety is improved based on the diastole period of the relative thinness of the wall of the ventricle, and the penetration of the wall of the ventricle is avoided (as shown in figure 8). At the moment, the injected medicine can be ensured to stay in the ventricular muscle and can not flow into the ventricular cavity or the pericardial cavity, so that the loss of the medicine and the occurrence of pericardial effusion are reduced. When the heart contracts, the wall of the chamber is further thickened, so that the animal safety is ensured to the greatest extent.

(5) The needle core of the thin puncture needle is withdrawn, the extension hose is connected, and the hand only fixes one end of the extension hose connected with the injector during injection, so that the thin puncture needle has a certain range of movement along with deep tissues, and secondary damage is reduced. The thin puncture needle is gradually retracted, and intermittent injection administration is performed in the retracting process, so that the multipoint administration of a single needle track can be completed.

(6) After the administration is completed, the thin puncture needle is retracted into the thick puncture needle, the pericardial effusion is observed by ultrasound, the blood circulation is stable, and then the thin puncture needle and the thick puncture needle are withdrawn from the chest wall together, so that the skin opening is sealed.

(7) The chest wall needle insertion position and needle tract are reselected under ultrasound guidance. The same patient may select two or more needle tracks for administration.

(8) After the administration of the puncture cardiac muscle is finished, the electrocardiograph and the pericardium are observed conventionally for 1 hour, if necessary, the tube is placed for drainage, the safety guarantee is improved, the operation is interrupted temporarily if necessary during the puncture process and after the operation, if the ventricular fibrillation and other malignant arrhythmia exist, the electric defibrillation is performed in time, and the operation can be continued after the stability. During the whole puncture operation process and 1 hour after operation, the support of trachea cannula and breathing machine, the monitoring of electrocardio blood pressure and blood oxygen saturation of experimental animals or subjects are carried out, puncture is stopped when an electrocardiogram finds frequent ventricular premature beat, the condition of heart rhythm is dynamically observed, and the possibility of occurrence of ventricular fibrillation is reduced. Stopping puncturing when ventricular fibrillation or unstable hemodynamics occurs, and rapidly determining the cause of the disease. If ventricular fibrillation is performed, immediate asynchronous defibrillation is performed, and intravenous lidocaine and epinephrine can be injected and defibrillation is performed again without success until sinus rhythm is restored. If pericardial effusion occurs, the hydrops dynamic change is monitored by ultrasound. If the effusion is less and the hemodynamics are stable, continuing to observe; if the effusion is rapidly increased or the hemodynamics is unstable, the most effusion part is determined by ultrasound, and the pericardial puncture catheterization is conducted under the guidance of ultrasound, and the drainage is continued after the operation until the effusion is reduced to a small amount and has no influence on the hemodynamics.

Examples

1. The instrument and instrument preparation mainly comprises a high-resolution ultrasonic diagnostic instrument, a heart ultrasonic probe, a probe puncture frame, a triple puncture needle and a 2ml syringe. Wherein the thick puncture needle, the thin puncture needle and the thin puncture needle core are all in strong echo under ultrasound so as to be convenient for positioning under ultrasound guidance.

2. Taking a supine position after animal anesthesia and dehairing, adjusting the position of an ultrasonic probe, selecting a short shaft middle section or a apex section of a left ventricle, determining a section and a position of a cardiac muscle to be administered by intervention according to scientific research or clinical requirements, and carrying out chest wall puncture by differently puncturing the needle cores of the coarse puncture needle, the fine puncture needle and the fine puncture needle which are arranged together at the upper edge of the next rib (as shown in figure 9); after the chest wall puncture is completed, the fine puncture needle and the fine puncture needle core are pushed out.

3. Changing the position of the ultrasonic probe and selecting puncture guide lines with different angles, considering the wall thickness of the chamber and ensuring that the intramyocardial injection point is positioned in the front wall or the anterior sidewall of the short axis of the left ventricle, and performing myocardial puncture when the included angle alpha between the fine puncture needle and the epicardial puncture point and the central connecting line of the short axis of the left ventricle meets 120 degrees or more and 150 degrees or less.

4. After the needle is inserted by the fine puncture, the electrocardiographic change is monitored, when ventricular premature beat occurs, the needle tip is prompted to reach the epicardium layer, at the moment, the ultrasonic image is closely observed, the needle insertion depth is determined according to the treatment requirement, and the injection administration position is selected under the condition that the needle tip is completely visible under the ultrasonic. For myocardial mini-pigs, ischemic areas above myocardial segments were selected for precise injection administration (see fig. 10 and 11).

5. When the thin puncture needle tip is positioned on the myocardium in the endocardium and the epicardium, and the distance D1 between the thin puncture needle tip and the endocardium and the distance D2 between the thin puncture needle tip and the epicardium are both larger than 2mm in diastole, the thin puncture needle tip is determined as an injection point.

6. The thin puncture needle core is withdrawn, an extension hose is connected to the base of the thin puncture needle, the thin puncture needle is fixed, a 2ml syringe is connected to the tail end of the extension hose, the three-way and the other syringe are used for pumping negative pressure and exhausting, the medicine is slowly injected, intermittent injection and medicine administration are carried out in the withdrawing process of the thin puncture needle, and the aim of multi-point medicine administration of a single needle channel can be fulfilled.

7. Taking down the injector after the drug administration is finished, reinserting the needle core of the fine puncture needle into the fine puncture needle, pushing the drug remained on the fine puncture needle into the part of the cardiac muscle to be interfered, then withdrawing the thoracic cavity together, and partially sealing to avoid pneumothorax. By adopting the same method, the puncture injection region can be reselected under the guidance of ultrasound, and the same experimental animal or subject can select 2-3 puncture points for puncture, so that the aim of multipoint injection at different sections and different depths in cardiac muscle is fulfilled. After the injection administration, only a small amount of needle eyes remain in the puncture part (see fig. 12).

8. And during the whole puncture operation process and 1 hour after operation, monitoring the electrocardio, blood pressure and blood oxygen saturation of the subject, suspending puncture when the electrocardiogram finds frequent ventricular premature beat, dynamically observing the condition of the heart rhythm, and reducing the possibility of ventricular fibrillation. Stopping puncturing when ventricular fibrillation or unstable hemodynamics occurs, and rapidly determining the cause of the disease. If ventricular fibrillation is performed, immediate unsynchronized defibrillation is performed, and intravenous lidocaine can not be successfully injected and defibrillation is performed again until sinus rhythm is restored. If pericardial effusion occurs, the hydrops dynamic change is monitored by ultrasound. If the effusion is less and the hemodynamics are stable, continuing to observe; if the effusion is rapidly increased or the hemodynamics is unstable, the most effusion part is determined by ultrasound, and the pericardial puncture catheterization is conducted under the guidance of ultrasound, and the drainage is continued after the operation until the effusion is reduced to a small amount and has no influence on the hemodynamics.

The application has the following advantages:

(1) The thick puncture needle is used for guiding the puncture to penetrate the chest wall, the defect that the conventional thin needle body is softer is overcome, and then the integrated thin needle and needle core are used for puncturing the cardiac muscle, so that the risks of local cardiac muscle injury and epicardial vascular injury are directly reduced. The fine puncture needle has small friction in the inner cavity of the coarse puncture needle, easy in-out and easy in-in, and the air tightness between the coarse puncture needle and the fine puncture needle can avoid pneumothorax. The thin puncture needle enters into deep tissues, the needle core is taken out, the thin puncture needle is connected with the injector through the extension hose, and the thin puncture needle can have a certain movement range along with myocardial tissues, so that the influence of heart beating on a drug delivery system is overcome, and the secondary damage of cardiac muscle is reduced.

(2) The injection device can achieve the purposes of single-needle-channel different-depth drug delivery, multiple-needle-channel multiple-position drug delivery at different angles and multiple injections at different time points under minimally invasive conditions, thereby achieving the purposes of multi-point injection at different sections and different depths in cardiac muscle and improving the drug delivery efficiency.

(3) The minimally invasive puncture technology under the high-resolution ultrasonic guidance is completely visible in operation, accurate in positioning and definite in drug administration without opening the chest.

(4) The heart structure and function can be observed dynamically in real time, complications can be found at the first time, the tube placement and drainage are convenient, and the safety guarantee is improved.

(5) Can be directly applied to scientific research practice, such as large animal myocardial infarction/heart failure model intervention research, and has safe and feasible operation. In the aspect of clinical transformation, the method is more suitable for treating heart failure patients with high conventional operation risk, greatly reduces operation risk, and enables early intervention of heart failure after myocardial infarction to be possible, thereby improving prognosis, and having good scientific research application value and clinical transformation value.

Claims

1. A triple needle device for trans-thoracic epicardial intramyocardial injection under ultrasound guidance, comprising: a coarse puncture needle, a fine puncture needle core and an extension hose;

The thin puncture needle comprises a second tube body, the first end of the second tube body is a tip end comprising an inclined plane, and the second end is a base; the length of the thin puncture needle is longer than that of the thick puncture needle; the fine puncture needle is used for puncturing cardiac muscle and providing medicines for cardiac muscle; when the second tube body of the thin puncture needle is inserted into the first tube body of the thick puncture needle, the second tube body and the first tube body are airtight;

The thin puncture needle core is solid, the first end is a tip comprising an inclined plane, and the second end is a base; when the thin puncture needle core is inserted into the second pipe body, the thin puncture needle core and the second pipe body are airtight;

the first end of the extension hose comprises an end seat, and the second end of the extension hose is used for being connected with an injection device;

An annular mark is arranged on the outer side of the second pipe body, and when the annular mark is aligned with the second end of the first pipe body, the first end of the second pipe body is aligned with the first end of the first pipe body;

a notch is formed on the second end of the base of the second pipe body; a protrusion is formed on a first end of the base of the thin lancet core; the protrusion can be clamped in the notch to align the first end of the second pipe body with the first end of the fine puncture needle core;

During the puncturing process, the thin puncture needle core is inserted into the second tube body; when the chest wall is punctured, the first end of the first tube body, the first end of the second tube body and the first end of the thin puncture needle core are aligned to form a flat inclined plane; when the cardiac muscle is punctured, the first end of the second tube body is aligned with the first end of the fine puncture needle core and extends out from the first end of the first tube body;

During the injection, the thin needle core is withdrawn from the second tube; the end seat of the extension hose is combined on the base of the second pipe body, so that the second pipe body is communicated with the extension hose; the second end of the extension hose connected with the injection device is only fixed during injection, so that the thin puncture needle has the range of movement along with deep tissues, and the secondary injury of cardiac muscle is avoided.

2. The triple puncture needle device of claim 1, wherein:

the outer side of the first tube body is provided with scales so as to confirm the needle inserting depth of the thick puncture needle;

3. The triple puncture needle device of claim 1, wherein:

The tip of the first end of the second tube is used to pierce the anterior and anterior walls of the short axis of the left ventricle, or the inferior and posterior walls of the left ventricle.

4. The triple puncture needle device of claim 1, wherein:

5. The triple puncture needle device of claim 1, wherein: