WO2021115260A1

WO2021115260A1 - Injection system capable of monitoring effectiveness of needle sticking

Info

Publication number: WO2021115260A1
Application number: PCT/CN2020/134555
Authority: WO
Inventors: 李彪; 胡晓明; 董娟
Original assignee: 宁波迪创医疗科技有限公司
Priority date: 2019-12-09
Filing date: 2020-12-08
Publication date: 2021-06-17
Also published as: CN110917448A

Abstract

Provided is an injection system capable of monitoring the effectiveness of needle sticking, comprising an injection needle (1), a back-suction component (2), an injection component (3), and an injection substance (5); the injection needle (1) is arranged at the far end of the injection system; the back-suction component (2) comprises a back-suction tube (21) and a back-suction power apparatus (22); the inner cavity of the injection needle (1) is in fluid communication with the inner cavity of the back-suction tube (21); the injection assembly (3) comprises an injection tube (31) and an injection control apparatus (32); the inner cavity of the injection needle (1) is in fluid communication with the inner cavity of the injection tube (31); the injection substance (5) is loaded in the injection tube (31); during operation, the position of piercing of the injection needle (1) is determined by means of the movement resistance of the back-suction power apparatus (22) in the suction tube (21). The injection system is used for monitoring the position of insertion of the injection needle (1), ensuring that the needle tip (11) is located inside a target tissue (9), such that the subsequent injection is safe.

Description

Injection system capable of monitoring the effectiveness of needle sticking

Related application

This application claims the priority of the Chinese patent application filed on December 9, 2019, with the application number 201911246442.3, titled "Injection system capable of monitoring the effectiveness of needle sticks", the full text of which is hereby incorporated by reference.

Technical field

This application relates to the technical field of medical devices, and in particular to an injection system that can monitor the effectiveness of needle sticking.

Background technique

Chronic heart failure (CHF) is a serious progressive disease and the ultimate destination of most cardiovascular diseases. The patient’s heart cannot pump enough blood to supply the whole body, and symptoms such as dyspnea, fatigue and fluid retention appear slowly. And gradually worsen, obviously affecting the quality of life.

The main pathological manifestations of CHF are left ventricle (LV) dilation and ventricular wall thinning, accompanied by progressive systolic dysfunction. Consistent with Laplace’s law, as the LV cavity increases and the ventricular wall becomes thinner, the pressure on the ventricular wall will increase, and the increased energy demand will lead to an increase in myocardial oxygen consumption (MVO2). The increase in MVO2 will aggravate myocardial cell deficiency. Oxygen promotes apoptosis of cardiomyocytes, leading to a vicious circle of pathophysiological responses such as harmful molecules and cell-mediated, which ultimately leads to further expansion of the LV heart cavity and thinning of the ventricular wall.

In view of the above pathological mechanisms, myocardial injection and filling is in the ascendant. This is a tissue engineering technique. The traditional method is to inject a myocardial filling material (for example: tissue engineering grade) into the free wall of LV through a commercially available syringe with injection needle. Biopolymers) increase the thickness of the ventricular wall and reduce the volume of the LV cavity, thereby reducing the LV wall pressure and reducing MVO2, reversing the further deterioration of CHF, improving its symptoms, and improving the quality of life of patients. Recently, a clinical study called AUGMENT HF showed that injection of a hydrogel Algisyl-LVR into the LV free wall of patients with advanced heart failure (ie: heart failure, HF) can improve the cardiac function and clinical outcome of patients. This operation is to make a few centimeters or tens of centimeters between the patient's ribs. In the area where the myocardium is thinned, it is mainly concentrated on the ventricular muscle fiber layer. Nearly 20 points are selected and a conventional syringe with a fixed injection needle length (6mm) is used. At the same time, the oblique needle puncture method is used to inject 0.3ml of alginic acid-based hydrogel into the beating heart. This operation requires the surgeon to make the correct target point for every needle puncture among as many as 20 needle puncture targets. Select and puncture the operation, especially pay attention: when selecting the point, avoid all blood vessels on the heart wall, and the needle should not penetrate the ventricular wall, so as to prevent the hydrogel from entering the blood vessels and blood and causing catastrophic embolism. Specifically, this operation There are the following problems and disadvantages in using traditional commercially available conventional syringes:

1. It is difficult to choose the target point of the needle, and there is a high risk of accidentally piercing the heart and blood vessel. Anatomically speaking, there are many coronary arteries and coronary venous blood vessels distributed in the heart wall. These blood vessels are small in size and often have different depths in the ventricular wall. In addition, various blood vessels on the heart have three-dimensional configurations. The distribution is also very irregular, and the distribution of blood vessels on the heart of different patients also has individual differences. In addition, the heart is deeply buried in the human body, surrounded by various tissues and important organs, and the area exposed to the surgeon’s field of vision will also be affected by the heart. It is extremely limited, so the surgeon cannot observe all the blood vessels with naked eyes, even with the help of medical equipment, it is difficult to identify them all. Therefore, it is difficult for the surgeon to completely avoid the various blood vessels mentioned above when choosing the target point for acupuncture. Point selection is difficult. If the surgeon directly chooses the target point of the needle based on his own experience, there will be the possibility of accidentally puncturing the heart blood vessel when puncturing the needle. If the key coronary artery that supplies blood to the heart is accidentally punctured, when the needle tip of the injection needle is just inside the vascular cavity, The myocardial filling material injected by the syringe will inevitably enter the blood vessel, causing the blood vessel to be narrowed or blocked, causing artificial myocardial infarction, and on the contrary, making the symptoms of heart failure more serious.

2. It is difficult to control the depth of the needle, and there is a fatal risk of piercing the ventricular wall. In fact, there are many peculiarities in the anatomical morphology of the heart, including: ①The anatomy of the heart has three grooves: the anterior interventricular groove, the posterior interventricular groove, and the coronary groove, as well as the left, right, and lower edges. The structure of the heart of different patients has different shapes. In addition, the outer surface of the heart is buried with the above-mentioned blood vessels, making the outer surface of the LV not smooth; ②The inner surface of the LV cavity has different shapes, because the LV cavity has different shapes. On the inner surface, there are many meat pillars, papillary muscles, etc., which make the inner surface uneven and have large fluctuations; ③For the same patient, the thickness of the ventricular wall is not constant: some positions have thicker ventricular walls, while some The thickness of the ventricle is thinner. Of course, for different patients, the thickness of the ventricular wall has a greater difference. Based on the particularity of the above-mentioned anatomy, if the surgeon uses a traditional syringe to perform multiple-point myocardial injection and filling in the patient, the depth of the injection needle into the left ventricular wall varies, which means that the myocardial filling material is injected The depth of implantation into the myocardium can be deep or shallow. Furthermore, when the thickness of the ventricular wall is less than the depth of the needle, for example, when the surgeon chooses to puncture the needle in the apical area, the thickness of the ventricle in the apical area is very thin. For people with dilated cardiomyopathy, the left ventricular wall has generally become thinner. These conditions are likely to cause the thickness of the ventricular wall to be less than the length of the injection needle, which can easily cause the injection needle to pierce the ventricular wall. When using the above-mentioned conventional syringes, Or, when the minimally invasive myocardial injection and filling operation is carried out through the endoscopic channel to the outer surface of the heart, the injection needle is stuck too deep and the needle tip is located in the left ventricular cavity. The subsequent injection will cause the myocardial filling material to directly enter the left ventricle. The ventricular cavity flows with blood into the blood vessels of the body, causing fatal risks such as clogged blood vessels. Of course, if the surgeon uses the minimally invasive myocardial interventional injection and filling operation that reaches the inner surface of the heart LV through the blood vessel channel to perform endocardial injection, the special shape of the inner surface of the LV cavity is also very easy to make the injection needle stick. The depth of entry into the left ventricular wall is different. It often happens that the needle tip is still located in the concave area of the inner surface of the LV cavity after the needle is punctured, such as between the meat column and the meat column, so it cannot really effectively penetrate into the ventricular wall. It can also cause fatal risks such as clogged blood vessels.

3. The operation requirements are strict and the beneficiaries are limited. One of the criteria for the selection of patients for this operation is to strictly control the thickness of the left ventricle ≥ 8mm, and require the surgeon to adopt the method of oblique needle insertion, and the whole operation must be performed under the guidance of real-time ultrasound equipment, which brings the following shortcomings: a) the operation The operator’s operating skills and technical proficiency requirements are particularly high. Due to the limited resolution of ultrasound equipment and the limited reach of the ultrasound probe on the body surface and in the body, the distance between it and the needle stick area is limited, even if it is Ultrasound equipment monitoring is implemented throughout the entire process, and it is impossible to completely ensure that the needle tip of the injection needle is located in the ventricular wall when the needle is inserted before each injection. There is a high risk of misjudgment; b) Needle insertion and injection at each injection point need to be carried out under the guidance of ultrasound equipment , It will cause the entire operation to take too long and endanger the life of the patient; c) Such stringent requirements are nothing more than to ensure that the needle tip is always located in the left ventricular wall and avoid puncturing the ventricular wall. However, many patients do not meet the requirements of the left ventricular wall. The selection criteria for ventricular thickness ≥8mm, for example, the left ventricular wall of patients with dilated cardiomyopathy has generally become thinner, and its wall thickness is even as low as 1-3mm, so this operation is not suitable for this type of patient population, and the scope of operation is limited . In addition, some countries or regions have a thinner heart muscle, which makes the beneficiaries of heart failure patients in these countries or regions more limited.

Therefore, there is an urgent need to design a clinically suitable for all kinds of channels, including the above-mentioned direct thoracotomy to expose the heart directly, the minimally invasive channel established through endoscopic instruments to reach the outer surface of the heart, and make full use of the human body. The existing minimally invasive interventional channel established by the cardiovascular system, etc., and the matching injection system for myocardial injection filling surgery, so as to effectively monitor the needle sticking process and avoid the injection needle from sticking to the non-target target position.

Summary of the invention

In view of this, the purpose of this application is to provide an injection system that can monitor the effectiveness of needle sticking, which is used to effectively monitor the needle sticking process before injection, avoiding the injection needle from penetrating the blood vessel on the heart wall, and preventing the injection needle from not penetrating the tissue This prevents the injection needle from penetrating too deeply and directly penetrating the left ventricular wall. The injection system of the present application can correctly determine the position of the needle tip, and then ensure the safety of each subsequent myocardial filling material injection, thereby solving the problem of filling the myocardium. The use of traditional syringes during surgery leads to difficult target selection and difficulty in controlling the depth of the needle, and ultimately leads to the safety problems endangering the life of the patient by injecting myocardial filling material into the cavity at the non-target target position.

The purpose of this application is achieved through the following technical solutions:

An injection system capable of monitoring the effectiveness of needle sticking. The injection system includes an injection needle, a suck back component, an injection component and an injection, the injection needle is arranged at the distal end of the injection system, and the suck back component includes A suction tube and a suction power device, the inner cavity of the injection needle is in fluid communication with the inner cavity of the suction tube, the injection assembly includes an injection tube and an injection control device, the inner cavity of the injection needle and the injection tube The inner cavity of the injection needle is in fluid communication, the proximal end of the injection needle is in a sealed connection with the suction tube and/or the distal end of the injection tube, and the injection is loaded in the injection tube. The movement resistance of the suction power device in the suction pipe is used to determine the position where the injection needle penetrates.

The purpose of this application is further achieved through the following technical solutions:

In some embodiments, the viscosity of the injection is between 5 mPa·s and 1000 mPa·s.

In some embodiments, the proximal end of the injection needle is connected to the suction tube or the distal end of the injection tube in a sealed manner, a communication port is provided in the distal region of the injection tube and the suction tube, and The communication port makes the inner cavity of the injection tube and the inner cavity of the suction tube fluidly communicate.

In some embodiments, a connection cavity is provided at the distal end of the suction tube and the injection tube, and the connection cavity is sealed to the injection needle, so that the inner cavity of the injection needle is connected to the suction tube respectively. The inner cavity of the injection tube is in fluid communication with the inner cavity of the injection tube.

In some embodiments, the injection tube and the suction tube are two independent lumens, and an opening is provided in the distal end region of the injection tube and the suction tube, and the opening forms the communication port Or the connecting cavity enables the inner cavity of the injection tube and the inner cavity of the suction tube to be in fluid communication.

In some embodiments, the injection tube and the suction tube are an integral double-lumen tube, and an opening is provided at the distal end portion of the side wall shared by the injection tube and the suction tube, and the opening forms the The communication port or the connecting cavity enables the inner cavity of the injection tube and the inner cavity of the suction tube to be in fluid communication.

In some embodiments, the value of the cross-sectional area S0 of the inner cavity of the injection needle satisfies: S0ε[0.008mm2, 0.3mm2].

In some embodiments, a separation membrane is provided at the communication port or the connection cavity. The separation membrane spans the entire communication port or the connection cavity, and the separation membrane has a microporous structure, so that the liquid loaded in the inner cavity of the suction pipe as the transfer medium and the liquid The lumen sucks back the fluid flowing into the system, such as blood, which can pass through the separation membrane, but the injection loaded in the lumen of the injection tube cannot pass.

In some embodiments, the injection assembly further includes a first non-return mechanism provided in the injection tube and/or on the proximal end of the injection tube.

In some embodiments, the first non-return mechanism is a manual switch valve structure that is hermetically connected to the proximal end of the injection tube, or the first non-return mechanism is provided in the inner cavity of the injection tube The structure of automatic switching valve.

In some embodiments, the suck-back assembly further includes a second non-return mechanism provided on the proximal end of the suck-back tube.

In some embodiments, the second non-return mechanism is a manual switch type valve structure that is hermetically connected with the proximal end of the suction tube.

In some embodiments, the manual switch type valve structure includes a rotary spool valve structure, a plunger reciprocating spool valve structure, or a plane reciprocating spool valve structure.

In some embodiments, the automatic switching valve structure is a valve structure composed of single or multiple check valve leaflets. When the valve structure is subjected to pressure from the proximal end to the distal end, the valve structure is The check valve leaflets are opened, and when the valve-like structure receives pressure from the distal end to the proximal direction, the check valve leaflets are closed.

In some embodiments, the suck-back power device includes a power source and a transmission medium, the power source is arranged outside the proximal end of the suck-back tube, and the transmission medium is at least partially located in the inner cavity of the suck-back tube , The transmission medium can move along the inner cavity of the suction pipe.

In some embodiments, the power source is directly provided by the surgeon, and the transmission medium is one or a combination of liquid and solid.

In some embodiments, the solid is a rod or tube.

In some embodiments, the rod or tube is fixedly connected to the suck-back piston or in a limit connection, and the length of the rod or tube is greater than the length of the suck-back tube.

In some embodiments, the power source is a pump, and the transmission medium is a liquid.

In some embodiments, the suck-back power device further includes a suck-back piston, the suck-back piston slidingly and sealingly cooperates with the suck-back tube, and the proximal surface of the suck-back piston always keeps contact with the transmission medium , The power source can drive the transmission medium and the suck-back piston to move in the inner cavity of the suck-back pipe.

In some embodiments, the injection control device includes an injection piston located in the lumen of the injection tube, an injection piston rod fixedly connected or limitedly connected with the proximal end of the injection piston, and always located at the proximal end of the injection tube The injection piston handle is fixedly connected with the injection piston rod, and the injection piston is slidingly sealed and fitted with the inner cavity of the injection tube.

In some embodiments, the suction piston and/or the injection piston are made of a polymer material with elasticity and shape recovery.

In some embodiments, the outer surfaces of the suction piston, the injection piston, the transmission medium, and the injection piston rod are provided with a material coating or covering layer with a surface friction coefficient ≤ 0.3.

In some embodiments, the suction piston, the injection piston, the rod body or tube body, and the injection piston rod are made of materials with a surface friction coefficient ≤ 0.3.

In some embodiments, the suck-back piston is one or more combinations of a cylinder, a saddle body, and a bead that are rotatably arranged along the central axis of the suck-back tube.

In some embodiments, the injection system further includes a monitoring mechanism.

In some embodiments, the monitoring mechanism is a monitoring chip set in the distal part of the injection system, or the monitoring mechanism is a monitoring mark set on the injection needle, or the monitoring mechanism is Observation parts made of light-transmitting materials.

In some embodiments, the length of the observation part is greater than or equal to 0.5 mm.

In some embodiments, the observation component is provided in the distal region of the injection system to facilitate the surgeon to observe the fluid entering the lumen of the injection system from the patient's lumen.

In some embodiments, the injection tube and/or the suction tube are made of a transparent material.

In some embodiments, the injection control device includes a refilling device in which the injection is contained, and the distal end of the refilling device is in communication with the injection tube.

In some embodiments, an interface with a detachable connection structure is provided at the proximal end of the injection tube, the proximal end and the distal end of the first non-return mechanism, and the distal end of the refill device, respectively. The proximal end of the first non-return mechanism is detachably and hermetically connected with the replenishing device, and the distal end of the first non-return mechanism is detachably and hermetically connected with the proximal end of the injection tube.

In some embodiments, the proximal end of the suction tube, the proximal end and the distal end of the second non-return mechanism, and the distal end of the suction power device are respectively provided with an interface with a detachable sealing connection structure. The proximal end of the second non-return mechanism is detachably and hermetically connected with the suction power device, and the distal end of the second non-return mechanism is detachably and hermetically connected with the proximal end of the suction tube.

In some embodiments, the detachable connection structure is one or a combination of a threaded structure, a plug-in fitting structure, and a buckle structure.

In some embodiments, the injection tube, the suction tube, the delivery medium, and/or the injection needle are made of a solid material that can be bent and deformed but will not be stretched or compressed.

In some embodiments, the solid material includes a polymer material with shape recovery properties, a metal material with a shape memory function and high elasticity, and a metal or polymer wire or thread is wound or twisted together in a spiral manner. Wire harness or cable with hollow or solid structure.

In some embodiments, the injection tube, the suction tube and/or the delivery medium are made of multilayer composite materials commonly used in minimally invasive interventional procedures.

In some embodiments, a fixed bending section or an adjustable bending section is provided at the distal end of the injection system, or a hollow movable limiting structure or joint connection structure is provided at the distal end of the injection system .

In some embodiments, the injection system is provided with a sheath with a fixed bend angle or can be adjusted in real time, and the injection system is provided in the sheath.

Compared with traditional technology, the beneficial effects of this application are mainly reflected in:

1. In the technical solution provided by this application, the proximal end of the injection needle forms a sealed connection with the suction tube and the distal end of the injection tube. The injection has been pre-loaded in the injection tube. During the operation, when the injection needle is inserted into the When the target tissue is inside, the resistance of the suction power device to the proximal end is large; when the injection needle is inserted into the cavity, the resistance of the suction power device to the proximal end is small, and the internal cavity The fluid enters the suction tube, so that the surgeon can directly observe the position change of the suction power device relative to the system through the naked eye, or through the hand resistance experience of the suction power device, you can quickly determine the needle point of the injection needle The position can effectively monitor the needle sticking process before injection, and ensure the safety of each subsequent myocardial filling material injection, so as to solve the difficulty in selecting the target point of the needle and controlling the depth of the needle due to the use of traditional syringes in operations such as myocardial injection filling. Eventually, it leads to safety problems that endanger the life of the patient caused by the injection of myocardial filling material into the cavity at the non-target location.

2. The suitable viscosity of the injection set in this application is 50mPa·s to 800mPa·s, and the injection tube with an inner diameter of 0.5mm to 4mm and a length of ≥200mm has injectable properties, but the fluidity is slightly poor, causing the injection The object can remain relatively static in the lumen of the injection tube, which facilitates the surgeon without additional auxiliary operations to directly control the handle of the suction piston to move the suction piston toward the proximal end, thereby ensuring the fluid in the lumen , It is not that the injection in the injection tube enters the suction tube, so the occurrence of misjudgment can be avoided.

3. The monitoring mechanism set up in this application enables the surgeon to quickly determine whether the needle tip is effectively penetrated into the target tissue, which significantly enhances the controllability of the system's penetration depth into the target tissue before injection, and greatly improves the system Operational safety.

4. The observation component made of light-transmitting material provided in this application is convenient for the surgeon to directly observe the changes in the fluid contained in the observation component. When the injection is made of colorless and transparent material, when the minimally invasive myocardial injection is performed through the endoscopic channel to the outer surface of the heart for epicardial injection and filling and the effectiveness of the needle puncture is judged, the surgeon can directly observe it with the naked eye Or the color of the fluid contained in the observation component is reddened by means of endoscopic light source equipment, which means that the injection needle has penetrated the entire ventricular wall so that the needle tip enters the ventricular cavity, or the needle tip has pierced the coronary artery in the ventricular wall In the blood vessel cavity, the needle penetration depth is not ideal at this time, it is necessary to adjust the needle penetration depth of the injection needle, or reselect other positions for needle penetration, so it is convenient to monitor the effectiveness of the needle penetration before injection.

5. In this application, the first non-reversal mechanism is set to a valve structure to ensure that the injection and refilling functions of the system are not affected, and it is convenient to preload the liquid and the filling in the system simply and quickly. Inside.

6. This application is provided with a manual switch valve structure at the proximal end of the suction tube and the proximal end of the injection tube, and the separation membrane with a microporous structure provided by this application, which not only ensures that the surgeon can quickly determine the position of the needle tip, but also The injection process at each targeted location went smoothly.

7. This application provides a refill device, which contains injections, so that the system does not need to be withdrawn from the body during the operation, but is loaded "in situ" in the body in real time, thereby satisfying the use of a set The injection system can quickly perform single or multiple replenishment and multiple injections in the body, greatly reducing the number of times that traditional syringes are repeatedly withdrawn and fed into the human or animal body, and not only reduces the passage of the human or animal body, but also For example, the risk of mechanical damage to the relatively fragile vascular system tissue wall also significantly shortens the entire operation time and reduces the operation risk.

8. This application provides a suction assembly and an injection assembly with various embodiments, which endow excellent bending adaptability and dimensional compatibility to the channel approach, excellent torque transmission and axial force transmission, and good spatial controllability. , It is convenient for the system to use minimally invasive surgery and minimally invasive interventional surgery to inject and fill the target tissue, and it is especially suitable for the minimally invasive myocardial injection and filling operation that reaches the outer surface of the heart through the endoscopic channel for epicardial injection.

Description of the drawings

In order to more clearly describe the technical solutions in the embodiments of the present application or the traditional technology, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the traditional technology. Obviously, the drawings in the following description are merely the present For the applied embodiments, for those of ordinary skill in the art, other drawings can be obtained from the disclosed drawings without creative work.

FIG. 1 is a schematic structural diagram of Embodiment 1 of this application.

2A to 2F are cross-sectional views of A-A and B-B of Fig. 1, wherein Figs. 2A and 2B, Fig. 2C and Fig. 2D, and Fig. 2E and Fig. 2F respectively show three different embodiments of the dual-lumen tube structure.

Figures 3A to 3E show the main working principle of the injection system provided by the present application. Figure 3A shows the state where the injection needle of the injection system has penetrated the entire ventricular wall and the needle tip has entered the ventricular cavity. On the basis of 3A, the state when the effectiveness of the needle puncture is being judged by pulling back the suction power device. Figure 3C shows that the needle tip of the injection system is located in the vascular cavity such as the coronary artery in the ventricular wall, and the suction power device is being pulled back Fig. 3D shows the state when the needle tip of the injection system enters the target tissue, and Fig. 3E shows the state when the needle is injected into a target site "in situ" on the basis of Fig. 3D. status.

4A and 4B show the structure of the monitoring mechanism in the second embodiment of the present application in two implementation manners.

Figure 5 is a schematic structural diagram of Embodiment 3 of this application.

6A to 6C are schematic structural diagrams of Embodiment 4 of the application, in which FIG. 6A is the momentary state of preparing to move the suction power device proximally to judge the effectiveness of the needle stick; FIG. 6B is the direction of the suction power device of FIG. 6A The momentary state when the proximal end moves a certain distance; Fig. 6C is the state when the injection at a target position is started.

Detailed ways

The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of this application.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field of this application. The terms used in the specification of the application herein are only for the purpose of describing specific embodiments, and are not intended to limit the application. The term "and/or" as used herein includes any and all combinations of one or more related listed items.

In order to more clearly describe an injection system that can monitor the effectiveness of a needle puncture provided by this application, the terms "proximal" and "distal" are defined herein, and the above-mentioned terms are common terms in the field of medical devices. Specifically, the "proximal end" refers to the end close to the operator during the operation, and the "distal end" refers to the end far away from the operator during the operation.

Example one:

As shown in Figures 1 to 2F, the present application provides an injection system that can monitor the effectiveness of needle sticking (hereinafter referred to as "the system"). The system includes an injection needle 1, a suck back component 2, an injection component 3, and an injection 5. The injection needle 1 is set at the distal end of the system and is fixedly connected to the distal end of the system. The suction assembly 2 includes a suction pipe 21 and a suction power device 22. The inner part of the injection needle 1 The cavity is in fluid communication with the cavity of the suction tube 21. The injection assembly 3 includes an injection tube 31 and an injection control device 32. The cavity of the injection needle 1 is in fluid communication with the cavity of the injection tube 31. The proximal end of the injection needle 1 forms a sealed connection with the suction tube 21 and/or the distal end of the injection tube 31, and the injection 5 has been pre-loaded in the injection tube 31. The movement resistance of the device 22 in the suction pipe 21 determines the position where the injection needle 1 penetrates. During operation, when the injection needle 1 is inserted into the target tissue 9, the resistance of the suction power device 22 to move proximally is large; when the injection needle 1 is inserted into the cavity 8, The resistance of the suction power device 22 to the proximal end is small, and the fluid 81 in the cavity 8 flows into the inner cavity of the injection needle 1 and finally enters the suction pipe 21.

In order to realize the function of fluid communication between the injection needle 1 and the suction tube 21 and the injection tube 31, from a design point of view, the present application has multiple implementation manners, for example, in the first implementation In the manner, as shown in Figs. 1 to 5, the proximal end of the injection needle 1 is first sealed to the distal end of the injection tube 31, and the distal end of the injection tube 31 and the suction tube 21 are arranged There is a communication port 20 so that the inner cavity of the injection tube 31 and the inner cavity of the suction tube 21 are in fluid communication. In the second embodiment, the proximal end of the injection needle 1 is first hermetically connected with the distal end of the suction tube 21, and a communication port 20 is provided in the distal region of the injection tube 31 and the suction tube 21. , So that the inner cavity of the injection tube 31 and the inner cavity of the suction tube 21 are in fluid communication. In the third embodiment, as shown in FIGS. 6A to 6C, a connecting cavity 4 is provided at the distal end of the suction tube 21 and the injection tube 31, and the connecting cavity 4 has a certain amount in the axial direction. Length, the connecting cavity 4 and the injection needle 1 are connected in a sealed manner, so that the cavity of the injection needle 1 is in fluid communication with the cavity of the suction tube 21 and the cavity of the injection tube 31 respectively.

For the convenience and economy of manufacturing, and considering the functional effectiveness of fluid communication between the injection needle 1 and the suction tube 21 and the injection tube 31, these three in this application The following two methods can be used for connection and communication. In the first embodiment, the manufacturing method includes the following steps:

① Single-lumen tubes of medical grade material, suitable size and hardness are selected as the injection tube 31 and the suction tube 21 respectively, and the injection tube 31 and the suction tube 21 are two independent lumens;

②Using grooves, holes or heating end forming on the side of the tube wall of the distal region of the injection tube 31 and the suction tube 21 respectively, so that the distal regions of both are formed with openings. The two openings are placed directly opposite each other, and the best form is that the boundary of the opening area just coincides;

③ Then select medical-grade material, suitable size and hardness tubing as the raw material of the sealed tube. The inner cavity of the sealed tube should be able to simultaneously contain the injection tube 31 and the suction tube 21 to hold the injection tube 31 and The suction pipe 21 is the best form;

④ Put the sealing tube on the injection tube 31 and the suction tube 21, the sealing tube should completely cover the opening area of the injection tube 31 and the suction tube 21, and the axial length of the sealing tube It needs to be greater than the axial length of the opening area, so that there is a sufficient length of the sealing connection area between the sealing tube and the injection tube 31 and the suction tube 21 outside the opening region;

⑤ Adopt a suitable sealing connection method in the sealing connection area to make the sealing pipe and the injection pipe 31 and the suction pipe 21 sealingly connected. The optional sealing connection methods include: a) between the sealing pipe and the suction pipe 21. An adhesive is injected into the gap between the injection pipe 31 and the suction pipe 21, so that the three are connected by glue. The adhesive includes, but is not limited to, polyurethane (TPU) solution and fluorinated ethylene propylene copolymer. (FEP) Emulsion, glue Loctite 3011, 3321, 3493, 3494, 3751, 4011, 4013, EA M-31CL; glue Dymax203a-cth-f, 204-cth-f, 1201-m-sc, 1128a-m; glue NuSil MED-2000P; Glue Dow Corning SILASTIC MEDICAL ADHESIVE SILICONE, TYPE A; b) Heating and melting or ultrasonic welding, etc., so that the three are directly integrated to achieve the shaping function of removing the step on the end face of the sealed tube, and the sealing connection performance The double effect. In this regard, the opening forms the communication port 20 or the connection cavity 4 so that the inner cavity of the injection tube 31 and the inner cavity of the suction tube 21 can be in fluid communication.

⑥ Select medical-grade material, suitable size and high-hardness tubing as the injection needle 1, and cut, grind, and polish the distal end of the injection needle 1 to form a certain inclination angle on the distal end. Depending on the requirements of the connection firmness, the proximal area of the injection needle 1 and the outer surface of the needle tube can be connected to form a connecting block by welding, bonding, melting, etc. The maximum size of the connecting block in the radial direction should be Close to the inner diameter of the injection tube 31 or the inner diameter of the suction tube 21, or close to the sum of the inner diameter of the injection tube 31 and the inner diameter of the suction tube 21, the purpose of this design is to make the injection needle 1 Form a more stable and effective connection with the injection tube 31 and/or the suction tube 21, avoiding the injection needle 1 which is usually made of metal material and the injection tube 31 and the return tube which are usually made of polymer material. The suction tube 21 has a huge difference in performance due to completely different materials and cannot be firmly connected. As a result, during clinical use, such as needle insertion or withdrawal, the injection needle 1 is opposed to the injection tube 31 and the suction tube 21. Move, or even detach from each other, so that the injection needle 1 falls off in the target tissue 9, thereby endangering the life safety of the patient;

⑦ Using the above-mentioned sealing connection method, the proximal region of the injection needle 1 is sealed and fixedly connected with the injection tube 31 and/or the suction tube 21 through the connection block.

In the second embodiment, the manufacturing method includes the following steps:

① Select a double-lumen tube with appropriate medical grade material, size, cross-sectional shape, and hardness as the injection tube 31 and the suction tube 21, and the injection tube 31 and the suction tube 21 are integrated double-lumen tubes. For this double-lumen tube, its outline should be fully considered outside the system may be designed to connect or assemble with the double-lumen tube and form parts that move with each other, such as the size of the inner cavity of the bending sheath, supporting use For example, the size of the lumen of the vascular sheath or endoscopic sheath, and the surgical approach, such as the size of the vascular cavity or the opening area of the chest. At the same time, the cross-sectional shape of the double-lumen tube should take into account the various clinical operations that may be required. Such properties, such as pushability, compliance with surgical approach, and bending compliance when the external bending sheath performs a bending operation, etc., therefore, its implementation is shown in FIG. 2A, FIG. 2C, and FIG. 2E.

②In the inside of the double-lumen tube, post-processing is used in the distal region of the side wall shared by the injection tube 31 and the suction tube 21 to form an opening, such as slotting, perforating, etc., as shown in Figure 2B, As shown in FIGS. 2D and 2F, the opening forms the communication port 20 or the connection cavity 4, so that the inner cavity of the injection tube 31 and the inner cavity of the suction tube 21 can be in fluid communication.

③The rest of the steps can refer to the steps ③ to ⑦ in the above first embodiment.

The suction power device 22 of this system includes a power source 223 and a transmission medium 221. The power source 223 is arranged outside the proximal end of the suction pipe 21, and the transmission medium 221 is at least partially located in the suction pipe 21. In the inner cavity of the suction tube 21, the transmission medium 221 can move along the inner cavity of the suction pipe 21. In some embodiments, the power source 223 is directly provided by the operator, and the transmission medium 221 is one of liquid and solid or a combination of both.

In this embodiment, the transmission medium 221 is solid. In some embodiments, the solid is a rod or tube. Further, the suck-back power device 22 further includes a suck-back piston 220, the suck-back piston 220 and the suck-back tube 21 are slidingly and sealedly fitted, and the proximal surface of the suck-back piston 220 is always in contact with the rod body. Or, the transmission medium 221 in the form of a tube body maintains contact and forms a connection, and the power source 223 can drive the transmission medium 221 and the suction piston 220 to move in the inner cavity of the suction pipe 21. In some embodiments, the rod or tube and the suction piston 220 form a fixed connection or a limit connection. The rod body or tube body will not undergo axial tension and compression deformation, and has good axial tension transmission and mechanical instant response. Therefore, this design makes it a surgeon of the power source 223 in clinical use. When the proximal region of the rod or tube is operated or the suction piston handle 222 fixedly connected to the proximal end of the rod or tube is operated, a certain pulling force is applied to the rod or tube to make the rod or tube When the pipe body moves in the suction tube 21, the rod or the distal end of the pipe body and the suction piston 220 can obtain the pulling force in a very timely manner, so that the surgeon can perceive or look directly at the transmission in time. Whether the distal end of the medium 221 has relatively moved in the lumen of the suction pipe 21, and make a quick judgment. In some embodiments, the length of the rod or tube is greater than the length of the suction tube 21, so that the proximal end of the rod or tube is always outside the proximal end of the system. Providing a suction piston handle 222 fixedly connected to the rod or tube at the proximal end thereof can enhance the operator's hand feeling comfort when operating the system.

As mentioned above, the injection assembly 3 includes the injection tube 31 and the injection control device 32. The injection control device 32 can be designed with reference to the aforementioned suction power device 22. Specifically, in this embodiment, The injection control device 32 includes an injection piston 320 located in the inner cavity of the injection tube 31, an injection piston rod 321 fixedly connected or limitedly connected to the proximal end of the injection piston 320, and always located at the proximal end of the injection tube 31 In addition, the injection piston handle 322 fixedly connected to the injection piston rod 321, the injection piston 320 is sliding and sealingly fitted with the inner cavity of the injection tube 31. In some embodiments, the injection piston rod 321 is solid, Specifically, it can be a rod body or a tube body. The injection piston rod 321 does not undergo axial tension and compression deformation, and has good axial tension transmission and mechanical instant response. Therefore, this design makes it in clinical use, When the surgeon, as the power source provider, operates the injection piston handle 322, for example, when a certain thrust is applied to the injection piston rod 321 to move a certain distance in the distal direction at a certain speed, the injection The piston 320 can obtain the thrust very timely and move the same distance at the same speed, thereby ensuring that the movement of the entire injection control device 32 relative to the injection tube 12 is completely synchronized. Therefore, it has been pre-loaded on the injection tube 31. The injection 5 inside can also inject a certain volume from the injection needle 1 at a uniform speed in the distal direction, and the volume of the injection 5 injected is exactly equal to the injection piston 320 The volume defined by the space that moves in the injection tube 31, when the injection tube 31 and/or the injection piston rod 321 is provided with a marking line 74 such as a display volume scale, as shown in FIGS. 6A to 6C This means that the surgeon can directly observe the changes in the injection process with the naked eye, thereby achieving precise control of the injection speed and the total injection volume of the injection 5.

As shown in Figure 3E, this system is used to safely inject the injection 5, especially various tissue engineering materials, into the target tissue 9, which has the physical characteristics of the edge contour. There is a cavity 8 outside the target tissue 9, and the cavity 8 is a tissue and organ that can contain or be filled with fluid 81, which is a substance that can flow in human or animal body tissues or organs, and the fluid 81 Including tissue fluid in the human or animal body, gas in the respiratory system, in some embodiments, the target tissue 9 includes ventricular wall, atrial wall, ventricular septum, atrial septum, blood vessel wall, and the cavity 8 includes a ventricular cavity , Atrial cavity, atrial appendage cavity, and blood vessel cavity. Correspondingly, the tissue fluid is blood in the human or animal body. At this time, the system will be used for minimally invasive cardiac surgery or minimally invasive cardiac interventional surgery.

When the system uses minimally invasive cardiac surgery or minimally invasive cardiac interventional surgery to inject and fill the target tissue, such as the myocardium of the left ventricular wall, the suction tube 21, the transmission medium 221, and the injection tube in the system 31 and the injection piston rod 321 are preferably made of solid materials that can bend and deform but do not undergo tensile and compression deformations to provide sufficient bending adaptability, torsion transmission and axial force transmission, considering the surgical passage The length and size of the access path, the axial length of the suction tube 21, the transmission medium 221, the injection tube 31, and the injection piston rod 321 in this system should be 50mm to 2000mm and the maximum size of the outer diameter ≤5mm, and to ensure excellent bending adaptability and size compatibility for the channel approach, to adapt to the internal channel of the endoscope or the tortuous cardiovascular system in the body, to ensure effective reach to the target tissue, such as the lesion site. In addition, the system can repeatedly rotate around its central axis and swing in the endoscope or wound protector during the operation, so as to perform targeted injections at dozens of points in the free wall area of the ventricular wall of the heart. Excellent torque transmission and axial force transmission make this system have good spatial maneuverability (including three-dimensional spatial positioning and other control properties), which is convenient for use in minimally invasive cardiac surgery or minimally invasive cardiac interventional surgery.

In this regard, in some embodiments, the above-mentioned solid material is a flexible material or an elastic material, including: a polymer material with shape recovery, such as silicone, rubber, silicone rubber, polyurethane, polyether block amide, polyolefin elastomer , Metal materials with shape memory function and high elastic performance, such as nickel-titanium alloy, cobalt-chromium alloy, platinum-tungsten alloy, a hollow or solid structure formed by winding or twisting metal or polymer wires or threads in a spiral manner Wire harness or cable. On this basis, the injection needle 1 is made of a solid material that can be bent and deformed but does not undergo stretching and compression deformation. The injection needle 1 is a micro-needle with a cross-sectional area S0 of the inner cavity. ∈[0.008mm2, 0.3mm2]; In one embodiment, the suction tube 21 and the injection tube 31 are made of a variety of medical materials commonly used in medical minimally invasive interventional procedures to become a multilayer composite material (such as The middle layer is a three-layer composite tube with braid braided mesh tube, and the middle layer is a three-layer composite tube with a coil spring tube, etc.). In another embodiment, the suction tube 21 and the distal end of the injection tube 31 Some parts are provided with fixed bending sections or adjustable bending sections, and can also be provided with hollow movable limiting structures or joint connection structures. The system can also optionally be provided with a sheath with a fixed bend angle or with real-time bend adjustment, and the suction tube 21, the injection tube 31 and the injection needle 1 are arranged in the sheath. For the suck-back piston 220 and the injection piston 320, they should be made of polymer materials with elasticity and shape recovery, such as silicone, rubber, silicone rubber, polyurethane, polyether block amide, polyolefin elastomer, etc. In one embodiment, the suction piston 220, the injection piston 320, the rod or tube, and the injection piston rod 321 are made of materials with a surface friction coefficient ≤ 0.3, and the materials include but Not limited to polyoxymethylene (POM), polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), high-density polyethylene (HDPE), ultra-high molecular weight polyethylene (UHMWPE); in another embodiment, the The outer surfaces of the suction piston 220, the injection piston 320, the transmission medium 220, and the injection piston rod 321 are provided with a material coating or coating layer with a surface friction coefficient of less than 0.3, and the coating or coating is provided. The coating can significantly reduce the outer surface of the suck-back piston 220 and the transmission medium 220, the injection piston 320 and the injection piston rod 321, and the inner cavity of the suck-back tube 21 and the inner cavity of the injection tube 31, respectively. The friction between the system improves the operating feel of the system, and the production cost is low, and does not affect the material selection. Therefore, the system is suitable for injecting the injection 5 of different viscosity or for a long injection stroke and an injection path. Tortuous in vivo injection.

For the injection 5 that has been loaded in the injection tube 31, before it is injected into the target tissue 9, it is a flowable fluid and has a moderate viscosity range. When the viscosity is between 5 mPa·s and When between 1000 mPa·s, the flow performance of the injection 5 is good, which not only enables the injection 5 loaded in the system to flow in the distal direction under the drive of the injection control device 32, and finally It is injected from the needle tip 11 of the injection needle 1, as shown in FIG. 3E. More importantly, it is also placed in the cavity of the system and located between the needle tip 11 and the distal end of the suction tube 21. The injection 5 can flow in the proximal direction, so that the suction power device 22 can play a role in the process of needle insertion target selection and needle insertion depth control before the injection, specifically, it is filled with myocardial injection As an example, when the needle tip 11 of the injection needle 1 is inserted into the cavity 8, it includes: the injection needle 1 pierces the entire ventricular wall 91 as shown in FIG. 3A and FIG. The needle tip 11 enters the ventricular cavity 82. As shown in FIG. 3C, although the injection needle 1 is in the ventricular wall 91, the needle tip 11 is located in the vascular cavity 83 such as the coronary artery in the ventricular wall 91. Although the needle sticking operation is performed, the needle tip of the injection needle 1 is not located in the myocardium of the ventricular wall 91. The surgeon can easily manipulate the suction power device 22 so that the transmission medium 221 faces the vicinity of the suction tube 21. Move in the end direction, and the resistance of the movement is small, the fluid 81 (that is, blood) in the cavity 8 will enter the suction tube 21, as shown in Figures 3B and 3C. At this time, the surgeon By looking directly at the position change of the suction power device 22 relative to the system, or by experiencing the hand-feel resistance of the suction power device 22, it can be quickly determined that the needle tip 11 of the injection needle 1 is not It effectively penetrates the myocardium, but penetrates the blood vessel on the heart wall, or penetrates the ventricular wall 91 and penetrates into the ventricular cavity, or the injection needle 1 is not penetrated, so it can be easily determined that the needle tip 11 is not located The correct judgment in the target tissue 9 can effectively monitor the needle sticking process before injection, and ensure the safety of each subsequent myocardial filling material injection, thereby solving the problem of using traditional syringes during myocardial injection filling and other operations to cause needle sticking to the target point. Difficult selection and difficulty in controlling the depth of the needle will eventually lead to safety problems endangering the life of the patient caused by the injection of myocardial filling material into the cavity 8 at a non-target target position.

The injection 5 applicable to this application may involve various myocardial filling materials, prosthetic filling materials, and tissue treatments, including cellulose derivative gels, xyloglucan gels, chitosan-based gels, and alginic acid. Base gel, chitin gel, acrylic-based gel and its derivative gel, polyglycolic acid, polylactic acid and its copolymer, polycaprolactone, polyhydroxyalkanoate, silk fibroin, polyanhydride, extracellular Substrate (ECM), various types of stem cells, various types of growth factors, small magnetic beads and magnetic powder, etc. In some embodiments, the injectable 5 also has self-curing or self-gelling properties, and the injectable 5 is a self-curing or self-gelling material. The surgeon can follow the actual clinical needs, for example, from loading to The total time required for mixing before the inner cavity of the injection tube 31 until injection into the target tissue 9 is required to select a material with a suitable self-curing or self-gelling time. In some embodiments, the self-curing or The self-curing or self-gelling time of the self-gelling material should be ≤30 min. In one embodiment, the self-curing or self-gelling time should be in the range of 0.5 min to 15 min. In short, the self-curing or self-gelling material should be able to complete the self-curing or self-gelling process in a timely manner, so as to shorten the operation time and reduce the potential risks of the operation. After the material is injected into the target tissue 9, the self-curing or self-gelling material starts and rapidly self-curing or self-gelling, which facilitates the self-curing or self-gelling in a single injection target. The material has a certain cohesive force to form a whole, so it stays in the target tissue 9 and prevents the injected self-curing or self-gelling material from being retracted along the injection needle 1 in the ventricle. The outflow of the pinhole channel gap formed in the wall 91 leaks, resulting in a situation that affects the safety and effectiveness of the operation.

This system is suitable for monitoring the effectiveness of the needle sticking process before injection, and then the injection is carried out to ensure the safety of the injection. As shown in Figures 3A to 3E, when the surgeon performs a minimally invasive myocardial injection filling operation and selects a gel with self-coagulating properties as the injection 5, the main working principle of the system is as follows:

1. Outside the body, operate the suction piston handle 222 to push the suction piston 220 to the distal area to ensure that the suction piston 220 effectively blocks the communication port 20. If necessary, the surgeon can hold the suck-back piston handle 222 in place, or the detachable connection structure provided between the suck-back piston handle 222 and the suck-back tube 21 to maintain the connection. The piston 220 keeps its position relative to the communication port 20, and then pushes the injection piston handle 322 slightly to move the injectable 5 loaded in the injection tube 31 and flowable toward the distal end to make the The inner cavity of the injection needle 1 is filled with the injection 5 to achieve the purpose of purging the air trapped in the cavity of the system and ensuring that no air enters the target tissue 9 in the subsequent injection process.

2. The surgeon can hold the injection piston handle 322 in place, or the detachable connection structure provided between the injection piston handle 322 and the injection tube 31 can keep the injection piston 320 in place. The position in the cavity of the injection tube 31 remains unchanged. The system and the fixed angle sheath or the adjusting sheath that may be assembled with the outside of the system, along a specific path, such as the vascular sheath and endoscopic sheath that have been in place in advance, enter the body to make all The injection needle 1 reaches the cavity of the left ventricle of the heart or the outer surface area of the left ventricle.

3. The surgeon can arbitrarily choose the needle position on the inner cavity surface or the outer surface of the left ventricle area, and can try different needle penetration depths at will. At this time, one of the following two types of situations will occur:

i) When the needle tip 11 is inserted, there are three cases of invalid needle insertion: ① The injection needle 1 as shown in FIG. 3A and FIG. 3B penetrates the entire ventricular wall 91 so that the needle tip 11 enters the ventricular cavity 82, ②As shown in FIG. 3C, although the injection needle 1 is in the ventricular wall 91, but the needle tip 11 is located in the vascular cavity 83 such as the coronary artery in the ventricular wall 91, ③the surgeon has performed a needle sticking operation However, the entire injection needle 1 does not touch the ventricular wall 91 from beginning to end. In these three cases, the surgeon can easily manipulate the suction piston handle 222 to make the suction piston 220 face the proximal end. The resistance of moving to the proximal end is small. The fluid 81 (that is, blood) in the channel 8 can be easily sucked back into the suction pipe 21, as shown in Figs. 3B and 3C. At this time, the surgeon can quickly determine that the needle tip 11 is not at the position by directly watching the position change of the suction power device 22 relative to the system, or by experiencing the hand resistance of the suction power device 22. State the correct judgment within the target organization 9. Then, the surgeon can directly switch to another set of this system to avoid that after judging that the needle stick is invalid, the blood drawn into the system and the injection 5 may penetrate each other, and even form a mixed zone, causing the injection 5 If the concentration of the injectable 5 is reduced, if the system continues to be used to inject the injectable 5 into the target tissue 9, the established performance and efficacy of the injectable 5 may be weakened.

ii) As shown in Figure 3D, when the needle tip 1 is inserted into the target tissue 9, although the target tissue 9 is a soft tissue but not a fluid, the suction tube 21 of this system cannot interact with all the tissues. The target tissue 9 in the outer area of the needle tip 1 is in fluid communication. Once the surgeon tries to pull back the suction piston handle 222 and tries to move the suction piston 220 toward the proximal end, in the system, the The area between the suck-back piston 220 and the injection piston 320 and the needle tip 1 will form a negative pressure space, and because the target tissue 9 is derived from and connected to the tissues or organs of the human or animal body, and the system is selected The needle of the injection needle 1 is a micro-needle that makes the system more minimally invasive, and its internal cavity cross-sectional area S0 is small, for example, S0 ∈ [0.008mm2, 0.3mm2], so the target tissue 9 will not be The suction enters the system, so the resistance of the suction power device 22 to move to the proximal end is huge, and even the surgeon cannot move the suction piston handle 222 in the proximal direction. At this time, the surgeon can Quickly make a correct judgment that the needle tip 11 is indeed located in the target tissue 9 and that the acupuncture is effective this time.

In summary, the surgeon can use the system provided by this application to try to pull back the suction piston handle 222 at any time during the needle sticking process before injection. If it cannot be pulled back, it means that the needle tip 11 has indeed penetrated the needle. If the inside of the target tissue 9 can be pulled back, it means that the needle tip 11 has not penetrated into the target tissue 9, but has entered the non-target tissue area, especially the cavity 8, so it can be easily and quickly Realize the effectiveness monitoring and correct judgment of the needle sticking process before injection.

It is worth noting that the greater the viscosity of the injection 5, the lower its fluidity. After a large number of exploratory experiments, we found that when the viscosity of the injection 5 is between 50mPa·s and 800mPa·s, the injection tube with an inner diameter of 0.5mm to 4mm and a length of ≥200mm 31 has injectable properties, but its fluidity is slightly poor, so that the injection 5 can spontaneously remain relatively still in the lumen of the injection tube 31, which facilitates the surgeon without additional auxiliary operations, such as Including holding the injection piston handle 322 to keep it still relative to the injection tube 31, and there is no need to provide a detachable connection structure between the injection piston handle 322 and the injection tube 31 for connection. If the injection piston 320 remains in place in the cavity of the injection tube 31, the suction piston handle 222 can be directly controlled to move the suction piston 220 toward the proximal end, thereby ensuring that the cavity 8 The fluid 81 is not the injection 5 in the injection tube 31 that enters the suction tube 21. Therefore, it is possible to avoid the inability to determine that the needle is effective, that is, the inability to correctly determine the occurrence of things.

4. After making a judgment on the effectiveness of the needle puncture and ensuring that the needle puncture is effective, the surgeon can keep the needle tip 11 at the needle puncture position, that is, the needle puncture depth in the ventricular wall 91 is unchanged, and then perform "in situ" For injection at a targeted location, for example, holding the proximal region of the injection tube 31 still, so that the injection piston handle 322 and the injection piston rod 321 move a certain distance in the distal direction at a certain speed. The injection 5 loaded in the injection tube 31 will be injected from the injection needle 1 at a certain injection speed into the target tissue 9, as shown in FIG. 3E, with the help of The marking line 74 such as a volume scale set on the injection assembly 3 enables the total amount of injection of the injection material 5 loaded in the injection tube 31 from the injection needle 1 to be accurately controlled.

During injection, the process of the injection 5 flowing toward the proximal end causes the suction piston 220 at the communication port 20 to receive a certain pressure, if the direction of the pressure is perpendicular to the central axis of the suction piston 220 , The position of the suck back piston 220 in the system will remain stationary, which can ensure a smooth injection process. For this purpose, the suck back piston 220 should be set to be rotatable along the central axis of the suck back pipe 21 One or more combinations of cylindrical, saddle, and beaded. Of course, for the sake of safety, the surgeon can also take enhanced measures, such as holding the suck back piston handle 222 in place, or a detachable connection structure provided between the suck back piston handle 222 and the suck back tube 21 In a similar manner, the suck-back piston 220 is kept in position relative to the communication port 20.

5. After the injection of a target position is completed, other needle positions can be selected according to the needs of the effectiveness of the operation, and the

above steps

3 and 4 are repeated to monitor and judge the effectiveness of the needle acupuncture twice or more. And multiple target injections until the total amount of the injection 5 injected into the target tissue 9 reaches the predetermined amount of the entire operation, and the injection is finally completed. Finally, the system is withdrawn to the outside of the body, and the myocardial injection filling operation is ended.

Example two:

Based on the first embodiment, the second embodiment is different from the first embodiment in that the system also includes a monitoring mechanism 7, so as to enhance the accuracy of the surgeon using the system to judge the effectiveness of the injection needle 1 , Improve the reliability of validity judgment. The monitoring mechanism 7 can be implemented in a variety of implementation manners.

In the first embodiment, the monitoring mechanism 7 is a monitoring chip 71 arranged in the remote part of the system. As shown in FIG. 4A, the monitoring chip 71 can generate one or more warning signals for blood. Therefore, the monitoring chip 71 may include detection reagents that identify certain components in blood, indicators or test papers that change color when encountering blood, luminescent reagents that emit light when encountering blood, and can sense certain components or components of blood. Sensor for blood pressure. The monitoring chip 71 can be embedded in the wall of the distal region of the system in a sheet, ring, or dot shape, or directly placed in the cavity of the distal region of the system, or it can be fixedly connected in a ring, dot shape, etc. The needle tip 11 of the injection needle 11 may also be embedded in the wall or the inner cavity of the injection needle 11 in a shape such as a line or a tube. If the surgeon tries to manipulate the suction piston handle 222 to move the suction piston 220 toward the proximal end during or after the needle is inserted, when it is found that the detection chip 71 generates any of the above warning signals, It means that the needle tip 11 or the detection chip 71 is in contact with blood, so it is convenient for the surgeon to make a correct judgment that the needle tip 11 is not located in the target tissue 9.

In the second embodiment, the monitoring mechanism 7 is a monitoring mark 72 provided on the injection needle 1. FIG. 4B shows that the monitoring mark 72 is located on the needle tip 11 of the injection needle 1. When this system is used for needle sticking before injection in minimally invasive surgery and minimally invasive interventional surgery, visualization can be realized with the help of medical imaging equipment connected to the computer screen, such as X-ray machines, ultrasonic imaging diagnostic equipment, etc., to facilitate the operation The person judges the position of the injection needle 1 in the ventricular wall 91. In this regard, the monitoring mark 72 may be fixedly connected to the needle tip 11 in a ring shape, a dot shape, or the like, or a line shape, a tube shape, etc. Buried on the wall of the injection needle 1, the material suitable for the monitoring mark 72 should have X-ray or ultrasonic visualization, including but not limited to such as tantalum, platinum, iridium, platinum-iridium alloy, cobalt, chromium, cobalt chromium Alloys, osmium, tungsten, rhodium, gold, palladium, rhenium, stainless steel and other metals or compounds such as barium sulfate, bismuth subcarbonate, bismuth oxychloride, zirconium oxide, bismuth oxide, titanium oxide, and niobium oxide are added. In particular, in order to further strengthen the real-time monitoring of the entire needle sticking process during the penetration of the injection needle 1 into the ventricular wall 91 of the present system, the needle tip 11 is located in the ventricular wall 91 without piercing. The ideal needle penetration depth makes the surgical process sufficiently safe. The distal region of the system, especially the injection needle 1, should be made of materials that can be monitored and observed by ultrasound imaging diagnostic equipment. In some embodiments , Is a medical metal material with a large difference in density from myocardial tissue, such as nickel-titanium alloy, cobalt-chromium alloy, platinum-iridium alloy, platinum-tungsten alloy, tantalum, gold, medical 304 stainless steel, 316L stainless steel, etc.

In other embodiments, the monitoring mechanism 7 is an observation component 73 made of a light-transmitting material. As shown in FIG. 6B, the observation component 72 can be set at any position in the remote area of the system, including Located at the distal end of the suction tube 21 and the injection tube 31, in the area of the connecting cavity 4, the observation component 72 can be inlaid on the wall of the system, or can be used as a structural member to be connected to the The proximal end of the injection needle 1, the suction tube 21, and the distal end of the injection tube 31 are fixed and sealed. In order to facilitate the operator to directly observe the inside of the system with eyes, the length of the observation component 72 should be sufficient, for example 0.5mm or more; and when the entire suction tube 21, the injection tube 31, and the connecting cavity 4 area are made of transparent materials, these areas become the observation part 73, and then the operation People have a wider field of view, with the help of medical optical systems, such as endoscopes, etc., it is convenient to observe the color changes of the fluid contained in the system. In particular, since blood is usually displayed in red, when the observation component 73 and the injection 5 loaded in the system are designed to use colorless and transparent materials, when the endoscopic channel is used to reach the heart During the minimally invasive injection and filling of myocardium with epicardial injection on the outer surface and judging the effectiveness of the needle puncture, the surgeon can directly observe with the naked eye or observe the color change of the fluid contained in the system by means of endoscopic light source equipment. Red, it also means that the injection needle 1 penetrates the entire ventricular wall 91 so that the needle tip 11 enters the ventricular cavity 82, or the needle tip 11 pierces the coronary artery and other vascular cavities in the ventricular wall 91 In 83, when the needle penetration depth is not ideal at this time, the needle penetration depth of the injection needle 1 needs to be adjusted, or the needle penetration target position is not ideal, other positions should be selected for needle penetration until the needle penetration is effective.

In short, the setting of the monitoring mechanism 7 enables the surgeon to quickly and correctly determine whether the needle tip 11 of the injection needle 1 effectively penetrates into the target tissue 9, which significantly enhances the system before injection. The controllability of the penetration depth of the target tissue 9 greatly improves the operational safety of the system.

Example three:

Based on the first embodiment, the first difference between the third embodiment and the first embodiment is that the power source 223 of the suction suction power device 22 is a pump arranged outside the suction pipe 21, and The transmission medium 221 is liquid, as shown in FIG. 5. Specifically, an extension tube may be provided on the pump, and an interface 25 with a detachable connection structure is provided on the distal end of the suck-back tube 21 and the proximal end of the extension tube, so as to facilitate the suck-back tube 21. It is detachably connected to the extension tube, and the entire interior of the suction tube 21 and the interior of the extension tube are pre-loaded and filled with the liquid, and the distal end of the liquid can be located at the communication port 20 and connected with The injection solution 5 pre-loaded in the injection tube 31 forms a liquid-liquid interface, and there is no air or bubble retention between the liquid and the injection solution 5, which makes the communication port 20 and the pump The liquid is used to achieve force transmission. When the system is used to determine the effectiveness of needle sticking, the pump is connected to the power source to generate a suction power source, and the pump can suck the liquid back. When the needle tip 11 is inserted When entering the cavity 8, the liquid can easily move in the proximal direction along the lumen of the suction tube 21 and be sucked back into the pump, which allows the surgeon to easily observe the liquid with the naked eye The suckback phenomenon is therefore more conducive to judgment. Of course, a pressure monitoring gauge 75 can be further provided at any position between the communication port 20 and the pump on the system, so that the surgeon can directly observe the pressure change of the liquid, if a certain pressure value is displayed , It can also assist in determining that the needle tip 11 is inserted into the cavity 8.

In some embodiments, the liquid is commonly used in interventional surgery such as heparin saline, physiological saline, contrast liquid, sterile water for injection, etc. The use of liquid as the transmission medium 221 has more prominent advantages than the first embodiment. Advantages include: a) During minimally invasive interventional surgery through the cardiovascular system or through the natural cavity, when a rod or tube is used as the transmission medium 221, the injection system passes through a tortuous blood vessel or natural cavity in the body At this time, the suction pipe 21 and the transmission medium 221 will be in a bent state at the same time. Pulling the rod or pipe body back will inevitably touch the inner wall of the suction pipe 21, causing greater friction between the two. At the slightest, the pull back resistance is relatively large, which affects the operating feel of the system, and at the worst, the rod or the tube body cannot move in the suction pipe 21, and then cannot suck back, which leads to misjudgment. However, this embodiment is This situation can be avoided. The liquid has no hardness, and can be abnormally prominently adapted to bend or match the more tortuous channels in the body, reducing the mechanical damage caused by the friction of the inner wall of the blood vessel or the inner wall of the channel. This advantage is just minimally invasive Required for interventional surgery; b) The power provided by the pump is non-artificial, and the operating comfort is high; c) The liquid has the advantage of minimal volume change when pressure is applied, which ensures the passage between the communication port 20 and the pump The liquid has sufficiently high force transmission efficiency and mechanical responsiveness when it transmits force. Of course, in order to maximize the efficiency of the liquid when transferring force, the area between the communication port 20 and the pump in the internal cavity of the system, as well as the part containing the liquid in the pump, should be airtight. status.

The second difference is that the injection control device 32 includes a refilling device 323 in which the injection 5 is contained, and the distal end of the refilling device 323 and the injection The proximal end of the tube 31 may be respectively provided with an interface 35 with a detachable connection structure, so that the two can be detachably connected. The design of the replenishing device 323 can refer to the injection control device 32 described in the first embodiment. The setting of the replenishing device 323 is convenient for the operator to replenish the system in time. When replenishing, the replenishing device 323 and the When the injection tube is connected, the surgeon pushes the injection piston rod 321 as shown in FIG. 6A, and the injection 5 contained in the refill device 323 is filled into the injection tube 31 to perform secondary and multiple targets. Point injection until the total amount of the injection 5 injected into the target tissue 9 reaches the predetermined amount of the entire operation to ensure the effectiveness of the clinical injection. This kind of feeding ensures that the system does not need to be withdrawn from the body during the operation, but is loaded in the body "in situ" and immediately, so that a single injection system can be used to quickly load the body or multiple times. And the requirement of multiple injections, greatly reducing the number of times that traditional syringes are repeatedly withdrawn and fed into the human or animal body, not only reduces the risk of mechanical damage to the human or animal body channel tissue, but also significantly shortens the entire operation time and reduces the risk of surgery.

The third difference is that the injection assembly 3 further includes a first non-return mechanism 33 arranged in the injection tube 31, and the first non-return mechanism 33 is an automatic switching valve structure. This automatic switching valve structure can be a valve structure 332 composed of a single or multiple check valve leaflets. FIG. 5 shows that the valve structure 332 is composed of two check valve leaflets. When the valve structure receives pressure from the proximal end to the distal end of the injection tube 31, the check valve leaflets open automatically, and when the valve structure receives pressure from the injection tube 31 from the distal end to the distal end When the pressure is in the proximal direction, the check valve flaps are automatically closed, which ensures that the injection and replenishment functions of the system are not affected. In addition, when the liquid is pre-loaded before the operation, the pump is operated. It releases the liquid, and the liquid flows through and fills the extension pipe, the suction pipe 21, and the communication port 20 from near to far. Then, the check valve leaflet will receive The pressure from the distal end to the proximal direction causes the check valve flap to close, ensuring that the liquid is filled into the injection needle and the inside of the injection needle 1, and then the pump is stopped and loaded on the The liquid inside the extension tube and the inside of the suction tube 21 can remain relatively static, and then the injection 5 is preloaded, and the injection 5 is added from the proximal end of the injection tube 31. The valve type The structure is subjected to pressure from the proximal end to the distal end of the feeding tube 31, the check valve flap is opened, and the liquid in the injection needle 1 will be removed from the needle tip 11 by the injection 5 As shown in Fig. 5, the liquid and the filler can be pre-loaded in the system simply and quickly.

Embodiment four:

As shown in Figures 6A to 6C, based on the third embodiment, the first difference between the fourth embodiment and the third embodiment is that the proximal end of the injection needle 1 is simultaneously connected to the suction tube 21 and the The distal end of the injection tube 31 is hermetically connected. In order to facilitate this connection, a connection cavity 4 is provided at the connection between the injection needle 1 and the suction tube 21 and the injection tube 31, and the connection cavity 4 is in the axial direction. It has a certain length so that the inner cavity of the injection needle 1 is in fluid communication with the inner cavity of the suction tube 21 and the inner cavity of the injection tube 31 respectively. In this system, the area of the connecting cavity 4 is all made of light-transmitting materials to form an observation part 73, which is convenient for the surgeon to directly observe the changes of the fluid contained in this area, such as the change of the fluid color. Since blood usually appears red, when the injection 5 loaded in this system is selected as a colorless and transparent material, when the endoscopic channel is used to reach the outer surface of the heart, the minimally invasive myocardial injection is performed. During the filling operation, when judging the effectiveness of the needle puncture, the surgeon directly observes with the naked eye or observes the color of the fluid contained in the connecting cavity 4 with the help of endoscope light source equipment and other means to turn red, which means that the injection needle 1 is pierced The entire ventricular wall 91 allows the needle tip 11 to enter the ventricular cavity 82, or the needle tip 11 penetrates into the coronary artery and other vascular cavity 83 in the ventricular wall 91. At this time, the needle penetration depth is not ideal, and the needle penetration depth of the injection needle 1 needs to be adjusted , Or re-select other positions for needle puncture, so it is convenient to monitor the effectiveness of needle puncture before injection.

The second difference is that a separation membrane 6 is provided at the communication port 20 or the connection cavity 4, and FIGS. 6A to 6C show that the separation membrane 6 is provided at the connection cavity 4. The separation membrane 6 spans the entire communication port 20 or the connection cavity 4. From a structural point of view, the separation membrane 6 has a microporous structure, and the micropores contained therein have a suitable size, so that the The liquid used as the transfer medium 221 in the inner cavity of the suck-back tube 21 and the fluid 81 sucked back into the system from the cavity 8 such as blood can pass through the separation membrane 6 and be loaded in the system. The injection 5 in the inner cavity of the injection tube 31 cannot pass through the separation membrane 6. Under this premise, in order to improve the sensitivity of the system for monitoring the effectiveness of the needle stick and the reliability of the correct judgment thereafter, the whole The injection needle 1 cavity, the connection cavity 4, and the entire return pipe 21 cavity are pre-loaded and filled with liquid as the transmission medium 221, as shown in FIG. 6A, and the liquid should be selected to be difficult to interact with the injection 5 Mixing without any physical and biochemical reactions, substances that do not affect the intended function of the injection 5, such as physiological saline and sterile water for injection, the above-mentioned design brings the benefits: as shown in Figure 6C, both ensure The timeliness and correctness of the monitoring and judgment of the effectiveness of the needle sticking is convenient for the surgeon to easily operate the injection control device 32 after making a judgment on the effectiveness of the needle sticking and ensuring that the needle sticking is effective, so that the injection 5 can only It flows toward the distal direction to reach the injection needle 1, and finally the injection enters the target tissue, and the injection 5 does not flow into the suction tube 21, thus ensuring the smooth progress of the subsequent injection process.

The third difference is that the first non-return mechanism 33 is arranged on the proximal end of the injection tube 31 and can be connected to the injection tube 31 in a sealed manner. The suck-back assembly 2 further includes a second non-reversal mechanism 23 which is arranged on the proximal end of the suck-back tube 21 and can be connected to the suck-back tube 21 in a sealed manner. The proximal end of the second non-return mechanism 23 is detachably and hermetically connected to the suction power device 22, and the distal end of the second non-return mechanism 23 is detachably and hermetically connected to the proximal end of the suction tube 21. The first non-return mechanism 33 and the second non-return mechanism 23 are both manual switch type valve structures. This manual switch type valve structure includes, but is not limited to, a rotary slide valve structure, a plane reciprocating slide valve structure, and a column. Plug reciprocating slide valve structure. As shown in FIGS. 6A to 6C, the second check mechanism is a rotary slide valve structure 231.

In this embodiment, the proximal end of the injection tube 31, the proximal end and the distal end of the first non-return mechanism 33, and the distal end of the refilling device 323 are respectively provided with an interface 35, and the first stopper The proximal end of the reverse mechanism 33 is detachably and hermetically connected to the refilling device 323, and the distal end of the first non-reverse mechanism 33 is detachably and hermetically connected to the proximal end of the injection tube 31; The proximal end, the proximal end and the distal end of the second non-return mechanism 23, and the distal end of the suction power device 22 are respectively provided with an interface 25, and the interface 25 and the interface 35 are detachable connection structures. The detachable connection structure includes a buckle structure or a plug-in fitting structure or a threaded structure. As shown in FIG. 5, a buckle structure 253 is provided at the proximal end of the suction pipe 21 and the distal end of the extension pipe; The proximal end of the injection tube 31 and the distal end of the feeding device 323 are provided with a plug-in fitting structure 352; as shown in FIG. 6A, the proximal end of the suction tube 21 and the distal end of the second non-return mechanism 23 The end is provided with a threaded structure 251. When the interface 25 is in a connected state, the suction pipe 21 is tightly connected to the extension pipe to ensure that the liquid does not leak out at the interface 25; The proximal end, the proximal end and the distal end of the first non-return mechanism 33, and the distal end of the refilling device 323 are provided with a threaded structure 351 to realize a detachable sealing connection.

As shown in FIG. 6A, the suck back power device 22 includes a suck back extension tube 24 that is detachably and sealedly connected to the proximal end of the second check mechanism 23, and the suck back extension tube 24 is located in the suck back extension tube 24. The suction piston 220, as the rod or tube body of the suction power device, the suction piston 220 and the suction extension tube 24 are slidingly and sealingly fitted, and the proximal end of the suction piston 220 is always in contact with the The rod or tube remains in contact and forms a connection. The liquid is pre-loaded in the suck-back tube 21 and the suck-back extension tube 24, and the liquid fills the distal end of the suck-back tube 21 and the suck-back tube 21. The space between the piston 220, therefore, the liquid, the suck-back piston 220 and the rod or tube are combined to form the transmission medium 221, and the power source 223 directly provided by the surgeon directly acts on the The proximal end of the rod or tube drives the rod or tube, and the suck-back piston 220 and the liquid move in the inner cavity of the suck-back extension tube 24 and the suck-back tube 21.

When the surgeon monitors and judges the effectiveness of acupuncture during the acupuncture process, as shown in Figures 6A and 6B, manually operate the first non-return mechanism 33 to close the valve, and at the same time, operate the second stopper. The reverse mechanism 23 opens the valve, and then judges the effectiveness of the needle sticking. Try to apply a certain pulling force to the rod or tube to make the rod or tube move proximally in the suction extension tube 24. If there is no resistance, the rod or tube can easily move in the proximal direction. It can be judged that the needle tip is not in the target tissue. This method helps the surgeon to quickly and accurately judge the correctness of the needle position. The distal end of the rod or tube and the suction piston 220 can obtain the pulling force in a very timely manner, and then the liquid in the system is attracted by the negative pressure, so that the liquid moves toward the proximal direction as a whole , And the filler 5 loaded in the injection tube 31 continues to remain relatively static, thus ensuring that the surgeon can quickly make a judgment that the needle tip 11 is not located in the target tissue 9 is correct.

After making a judgment on the effectiveness of the puncture and ensuring that the puncture is effective, the surgeon can keep the needle tip 11 at the puncture position, that is, the depth of the needle in the ventricular wall 91 remains unchanged, and then implement a target "in situ" The steps for the injection to the position point include at least: manually operating the first non-return mechanism 33 to open the valve, and manually operating the second non-return mechanism 23 to close the valve; then, refer to the third embodiment. The feeding device 323 is used to perform single and multiple targeted injections to ensure the smooth progress of the injection process at each targeted location, and ultimately meet the safety of the surgeon using this system for single and multiple injections And effectiveness.

The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, all possible combinations of the various technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, All should be considered as the scope of this specification.

The above-mentioned embodiments only express several implementation manners of the present application, and their description is relatively specific and detailed, but they should not be interpreted as a limitation on the scope of the patent application. It should be pointed out that for those of ordinary skill in the art, without departing from the concept of this application, several modifications and improvements can be made, and these all fall within the protection scope of this application. Therefore, the scope of protection of the patent of this application shall be subject to the appended claims.

Claims

An injection system capable of monitoring the effectiveness of needle sticking, characterized in that: the injection system includes an injection needle (1), a suck back component (2), an injection component (3), an injection (5), and the injection needle ( 1) Set at the distal end of the injection system, the suction assembly (2) includes a suction tube (21) and a suction power device (22), and the inner cavity of the injection needle (1) is connected to the suction The inner cavity of the suction tube (21) is in fluid communication, the injection assembly (3) includes an injection tube (31) and an injection control device (32), and the inner cavity of the injection needle (1) is connected to the injection tube (31). The inner cavity is in fluid communication, the injection (5) is loaded in the injection tube (31), and during operation, the suction power device (22) moves in the suction tube (21) The resistance is used to determine where the injection needle (1) penetrates.
The injection system capable of monitoring the effectiveness of needle sticking according to claim 1, wherein the proximal end of the injection needle (1) is sealed with the suction tube (21) or the distal end of the injection tube (31) Connected, a communication port (20) is provided in the distal region of the injection tube (31) and the suction tube (21), and the communication port (20) makes the inner cavity of the injection tube (31) and the The inner cavity of the suction pipe (21) is in fluid communication.
The injection system capable of monitoring the effectiveness of needle sticking according to claim 1, characterized in that a connection cavity (4) is provided at the distal end of the suction pipe (21) and the injection pipe (31), and the connection The cavity (4) is in sealed connection with the injection needle (1), so that the internal cavity of the injection needle (1) is connected to the internal cavity of the suction tube (21) and the internal cavity of the injection tube (31) respectively. Connected.
The injection system capable of monitoring the effectiveness of needle sticking according to claim 2 or 3, characterized in that a separation membrane (6) is provided at the communication port (20) or the connection cavity (4).
The injection system capable of monitoring the effectiveness of needle sticking according to claim 1, characterized in that, the injection assembly (3) further comprises a device arranged in the injection tube (31) and/or the injection tube (31) A first non-reverse mechanism (33) on the proximal end, the suck-back assembly (2) further includes a second non-reverse mechanism (23) arranged on the proximal end of the suck-back tube (21).
The injection system capable of monitoring the effectiveness of needle sticking according to claim 1, wherein the suction power device (22) comprises a power source (223) and a transmission medium (221), and the power source (223) is It is arranged outside the proximal end of the suction pipe (21), the transmission medium (221) is at least partially located in the inner cavity of the suction pipe (21), and the transmission medium (221) can travel along the suction pipe ( 21) The inner cavity moves.
The injection system capable of monitoring the effectiveness of needle sticking according to claim 6, characterized in that the suction power device (22) further comprises a suction piston (220), the suction piston (220) and the suction The suction tube (21) is slid and sealed, and the proximal surface of the suck-back piston (220) is always in contact with the transmission medium (221), and the power source (222) can drive the transmission medium (221) and The suction piston (220) moves in the inner cavity of the suction pipe (21).
The injection system capable of monitoring the effectiveness of needle sticking according to claim 1, characterized in that the injection system further comprises a monitoring mechanism (7).
The injection system capable of monitoring the effectiveness of needle sticking according to claim 1, wherein the monitoring mechanism (7) is a monitoring chip (71) arranged in the distal part of the injection system, or the monitoring The mechanism (7) is a monitoring mark (72) provided on the injection needle (1), or the monitoring mechanism (7) is an observation component (73) made of a light-transmitting material.
The injection system capable of monitoring the effectiveness of needle sticking according to claim 1, wherein the injection control device (32) comprises a refilling device (323), and the refilling device (323) contains the For the injection (5), the distal end of the feeding device (323) is connected with the injection tube (31).