CN110917448A

CN110917448A - Injection system capable of monitoring effectiveness of needle insertion

Info

Publication number: CN110917448A
Application number: CN201911246442.3A
Authority: CN
Inventors: 李彪; 胡晓明; 董娟; 陈超; 陈琦
Original assignee: Ningbo Di Chuang Medical Technology Co Ltd
Current assignee: Ningbo Di Chuang Medical Technology Co Ltd
Priority date: 2019-12-09
Filing date: 2019-12-09
Publication date: 2020-03-27
Also published as: WO2021115260A1

Abstract

The utility model relates to a can monitor injection system of needle punching validity, including the syringe needle, the resorption subassembly, injection subassembly and injection thing, the syringe needle is set up the distal end at injection system, the resorption subassembly includes resorption pipe and resorption power device, the inner chamber of syringe needle and the inner chamber fluid intercommunication of resorption pipe, the injection subassembly includes syringe and injection controlling means, the inner chamber of syringe needle and the inner chamber fluid intercommunication of syringe, the injection thing is loaded in the syringe, in operation process, judge the position that the syringe needle pierced through the moving resistance of resorption power device in the resorption pipe. The needle inserting device is used for monitoring the inserting position of the injection needle, and ensures that the needle point is located in target tissue, so that subsequent injection is safe.

Description

Injection system capable of monitoring effectiveness of needle insertion

Technical Field

The application relates to the technical field of medical instruments, in particular to an injection system capable of monitoring the effectiveness of a needle insertion.

Background

Chronic Heart Failure (CHF) is a serious progressive disease and the ultimate destination of most cardiovascular diseases, the heart of a patient cannot pump enough blood to supply to the whole body, and symptoms such as dyspnea, fatigue and fluid retention of the patient slowly appear and gradually get worse, which obviously affects the quality of life.

The major pathologies of CHF are manifested by Left Ventricular (LV) dilation and ventricular wall thinning, with progressive systolic dysfunction, etc. Consistent with Laplace's law, as the LV chamber increases and the ventricular wall becomes thinner, it leads to increased pressure on the ventricular wall, and thus increased energy demand leads to increased myocardial oxygen consumption (MVO2), and an increase in MVO2 aggravates myocardial hypoxia and promotes apoptosis of myocardial cells, thereby leading to a vicious circle of a series of pathophysiological responses, such as harmful molecules, cell-mediated responses, and finally leading to further enlargement of the LV chamber and thinning of the ventricular wall.

In view of the above pathological mechanisms, the myocardial injection filling technique is a tissue engineering technique, and the existing method is to inject a myocardial filling material (such as tissue engineering-grade biopolymer) into the free wall of the LV through a commercially available syringe with a syringe needle at multiple points to increase the ventricular wall thickness and reduce the LV cardiac cavity volume, thereby reducing the LV ventricular wall pressure and MVO2, reversing the further deterioration of CHF, improving the symptoms and improving the life quality of patients. Recently, a clinical study named AUGMENT HF has shown that the injection of a hydrogel Algisyl-LVR into the LV free wall of patients with advanced heart failure (i.e., heart failure, HF) improves the patient's cardiac function and clinical outcome. The operation is to open a plurality of centimeters or tens of centimeters between ribs of a patient, mainly concentrate on a ventricular muscle fiber layer in a thinned region of a cardiac muscle, select nearly 20 points, use a conventional syringe with a fixed injection needle length (6mm), and implant 0.3ml of alginic acid-based hydrogel for the injection of a beating heart by adopting an inclined needle insertion mode, and the operation requires that an operator must make correct target point selection and needle insertion operation in up to 20 needle insertion target points each time, and particularly needs to pay attention to: in the selection, all blood vessels on the heart wall are avoided, and the needle cannot penetrate the heart wall, so that the hydrogel can not enter the blood vessels and blood to cause catastrophic embolism, and particularly, the operation uses the prior art conventional syringe sold on the market, and has the following problems and disadvantages:

1. the selection of the needle inserting target point is difficult, and the high risk of mistakenly inserting the heart blood vessel exists. Anatomically, a plurality of coronary artery blood vessels and coronary vein blood vessels are distributed in the heart wall, the blood vessels are small in size, the positions in the heart wall are often different in depth, in addition, various blood vessels on the heart have three-dimensional spatial configurations and are also extremely irregular in distribution, the blood vessel distribution on the heart of different patients also has personalized differences, in addition, the heart is deeply buried in a human body, various tissues and important organs are surrounded by the periphery of the heart, the area of the heart exposed in the visual field of an operator is also extremely limited, so that the operator cannot observe all the blood vessels by eyes, even by means of medical equipment, the operator cannot completely avoid the various blood vessels when selecting a needle insertion target point, and the needle insertion target point is difficult to select. If an operator directly selects an acupuncture target point only by self experience, the possibility of mistakenly puncturing a cardiac blood vessel exists, and if the operator mistakenly punctures a key coronary artery supplying blood to the heart, when the needle point of the injection needle is just positioned in a blood vessel cavity, a myocardial filling material injected by the injector is forced to enter the blood vessel, so that the blood vessel is narrowed or blocked, artificial myocardial infarction is caused, and the heart failure symptom is more serious due to the reverse.

2. In fact, the anatomical morphology of the heart has a plurality of specificities, including ① heart has three grooves of anterior interventricular sulcus, posterior ventricular sulcus and coronary sulcus, and the anatomical structures of the left edge, the right edge and the lower edge, different patients' hearts have different shapes, besides, the outer surface of the heart is buried with the blood vessels, so that the outer surface of the LV is not smooth, ② LV cavity has different inner surface shapes, because there are a plurality of columella, papillary muscle and the like distributed on the inner surface of the LV cavity, so that the inner surface is uneven and the difference is large, ③ for the same patient, the thickness of the ventricular wall is not constant, some positions have thicker ventricular wall, some positions have thinner ventricular wall, and certainly, different patients have larger difference of the thickness of the ventricular wall, and the special ventricular wall thickness thereof is not easy to be used for the patient to perform the myocardial injection, if the patient adopts the injector of the prior art to perform the myocardial injection on the myocardial wall of the patient, the myocardial injection, the needle point is injected into the deep ventricular wall of the myocardial wall, so that the myocardial injection, the myocardial injection is not easy to enter the myocardial wall of the myocardial wall, the myocardial injection is not easy to reach the deep myocardial injection, the deep myocardial injection is not easy to be the deep myocardial injection, the deep myocardial injection needle is not easy to be used, the deep myocardial injection needle is not easy to fill the deep myocardial injection, the deep myocardial injection is not easy to fill needle is not easy to fill the deep myocardial injection, the deep myocardial injection needle is not easy to fill the deep.

3. The operation is strict and beneficial to people is limited. One of the patient selection criteria for the operation is that the left ventricle thickness is strictly controlled to be more than or equal to 8mm, an operator is required to adopt an inclined needle insertion mode, and the whole process of the operation needs to be conducted under the guidance of real-time ultrasonic equipment, which brings the following defects: a) the requirements on the operating skill and the technical skill of an operator are particularly high, the resolution of ultrasonic equipment is limited, the positions touched by an ultrasonic probe on the body surface and in the body are limited, the distance between the ultrasonic probe and a needle inserting area is limited, even if the ultrasonic equipment is monitored in the whole process, the needle point of an injection needle cannot be completely ensured to be positioned in the ventricular wall when the needle is inserted before each injection, and the high risk of misjudgment exists; b) the needle insertion and injection at each injection point are performed under the guidance of ultrasonic equipment, so that the time consumption of the whole operation is too long, and the life of a patient is threatened; c) such a severe requirement is not intended to ensure that the needle tip is always located in the left ventricular wall to avoid puncturing the ventricular wall, but not a few patients do not meet the selection standard that the left ventricular wall is thicker than or equal to 8mm, for example, the left ventricular wall of patients with dilated cardiomyopathy is generally thinned, and the wall thickness is even as low as 1-3mm, so the operation is not suitable for the patients of the same kind, and the operation application range is limited. In addition, the cardiac muscle of the people in China has the characteristic of being thinner, so that the people who benefit heart failure patients in China are more limited.

Therefore, it is an urgent need to design an injection system suitable for myocardial injection filling operation through various channels, including the direct-viewing heart-exposing huge wound channel created by opening the chest, the minimally invasive channel created by reaching the outer surface of the heart through the endoscope and other instruments, the minimally invasive intervention channel created by fully utilizing the existing cardiovascular system in the human body, so as to effectively monitor the needle insertion process and avoid the injection needle from being inserted into the non-target point.

Disclosure of Invention

In view of this, an object of the present invention is to provide an injection system capable of monitoring needle insertion effectiveness, which is used for effectively monitoring a needle insertion process before injection, preventing an injection needle from being inserted into a blood vessel on a heart wall, preventing the injection needle from not being inserted into a tissue, and further preventing the injection needle from being inserted too deeply and directly penetrating through a left ventricle wall.

The purpose of the application is realized by the following technical scheme:

an injection system for monitoring the effectiveness of a needle insertion, the injection system comprising an injection needle disposed at a distal end of the injection system, a retraction assembly comprising a retraction tube and a retraction motor, the needle having a lumen in fluid communication with the lumen of the retraction tube, the injection assembly comprising a syringe and an injection control device, the needle having a lumen in fluid communication with the syringe lumen, the needle having a proximal end sealingly connected to the retraction tube and/or the distal end of the syringe, and an injectate loaded into the syringe, wherein during operation the needle penetration position is determined by the resistance to movement of the retraction motor within the retraction tube.

The purpose of the application is further realized by the following technical scheme:

in some embodiments, the viscosity of the injectate is between 5 mPa-s and 1000 mPa-s.

In some embodiments, the proximal end of the injection needle is sealingly connected to the return straw or the distal end of the injection tube, and a communication port is provided at the distal end regions of the injection tube and the return straw, the communication port fluidly communicating the lumen of the injection tube and the lumen of the return straw.

In some embodiments, a connection cavity is provided at the distal ends of the pipette and the syringe tube, the connection cavity being in sealed connection with the injection needle such that the lumen of the injection needle is in fluid communication with the lumen of the pipette and the lumen of the syringe tube, respectively.

In some preferred embodiments, the injection tube and the return straw are two separate lumens, and an opening is provided in the distal end region of each of the injection tube and the return straw, the opening forming the communication port or the connecting lumen to enable fluid communication between the injection tube lumen and the return straw lumen.

In some preferred embodiments, the injection tube and the return straw are an integral double-lumen tube, and an opening is provided at a distal end portion of a common side tube wall of the injection tube and the return straw, and the opening forms the communication port or the connection cavity, so that the injection tube inner cavity and the return straw inner cavity can be in fluid communication.

In some preferred embodiments, the needle lumen cross-sectional area S0 has a value that satisfies: S0E is [0.008mm2, 0.3mm2 ].

In some preferred embodiments, a separation membrane is provided at the communication port or at the connection chamber. The separation membrane spans the whole communication port or the connection cavity, and the separation membrane has a microporous structure, so that the liquid as the transfer medium loaded in the inner cavity of the pipette and the fluid flowing back into the system from the cavity channel, such as blood, can pass through the separation membrane, but the injectate loaded in the inner cavity of the syringe cannot pass through the separation membrane.

In some embodiments, the injection assembly further comprises a first backstop mechanism disposed within the syringe and/or on a proximal end of the syringe.

In some preferred embodiments, the first non-return mechanism is a manually-operated valve structure sealingly connected to the proximal end of the syringe, or the first non-return mechanism is an automatically-operated valve structure disposed in the lumen of the syringe.

In some embodiments, the suck back assembly further comprises a second backstop mechanism disposed on the proximal end of the suck back tube.

In some preferred embodiments, the second non-return mechanism is a manually operated valve structure sealingly connected to the proximal end of the return straw.

In some preferred embodiments, the manual switch type valve structure includes a rotary slide valve structure, a plunger reciprocating slide valve structure, or a planar reciprocating slide valve structure.

In some preferred embodiments, the automatically opening and closing valve structure is a valve-type structure consisting of one or more check valve leaflets that open when the valve-type structure is subjected to pressure from a proximal-to-distal direction and close when the valve-type structure is subjected to pressure from a distal-to-proximal direction.

In some embodiments, the suction power device comprises a power source disposed outside the proximal end of the suction tube and a transmission medium at least partially disposed within the lumen of the suction tube, the transmission medium being movable along the lumen of the suction tube.

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

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

In some preferred embodiments, the rod or the tube is fixedly or limitedly connected to the suck-back piston, and the length of the rod or the tube is greater than that of the suck-back pipe.

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

In some preferred embodiments, the suck-back power unit further comprises a suck-back piston, the suck-back piston is in sliding sealing fit with the suck-back pipe, a proximal end face of the suck-back piston is always in contact with the transmission medium, and 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 comprises an injection piston located in the inner cavity of the injection tube, an injection piston rod fixedly or limitedly connected with the proximal end of the injection piston, and an injection piston handle always located outside the proximal end of the injection tube and fixedly connected with the injection piston rod, wherein the injection piston is in sliding sealing fit with the inner cavity of the injection tube.

In some preferred embodiments, the suck back piston and/or the injection piston are made of a polymeric material having elasticity and shape recovery.

In some preferred embodiments, the outer surfaces of the suck-back piston, the injection piston, the transmission medium and the injection piston rod are provided with a material coating or cladding having a surface friction coefficient of 0.3 or less.

In some preferred embodiments, the suck back piston, the injection piston, the rod or tube and the injection piston rod are made of a material having a surface friction coefficient of 0.3 or less.

In some preferred embodiments, the suck-back piston is one or more of a cylinder, a saddle, and a bead rotatably disposed along the central axis of the suck-back tube.

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

In some preferred embodiments, the monitoring mechanism is a monitoring chip disposed in a distal portion of the injection system, or the monitoring mechanism is a monitoring marker disposed on the injection needle, or the monitoring mechanism is a viewing member made of a material having light transmissivity.

In some preferred embodiments, the length of the viewing member is greater than or equal to 0.5 mm.

In some preferred embodiments, the visualization component is disposed at a distal region of the injection system to facilitate visualization of fluid from the patient's tract into the lumen of the injection system by the operator.

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

In some embodiments, the injection control device comprises a feeding device, the feeding device contains the injectate therein, and the distal end of the feeding device is communicated with the injection tube.

In some preferred embodiments, 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 feeding device are respectively provided with a connector with a detachable connection structure, the proximal end of the first non-return mechanism is detachably and hermetically connected with the feeding 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 preferred embodiments, the proximal end of the suction pipe, 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 a connector having 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 pipe.

In some more preferred embodiments, the detachable connection structure is one or more of a combination of a screw structure, a plug-and-pull matching structure and a buckling structure.

In some embodiments, the injection tube, the return straw, the transfer medium, and/or the injection needle are made of a solid material that is capable of bending deformation without stretching and compression deformation.

In some preferred embodiments, the solid material comprises a polymer material having shape-recovery properties, a metal material having shape-memory function and high elastic properties, a wire bundle or cable in which metal or polymer filaments or wires are wound or twisted together in a spiral manner to form a hollow or solid structure.

In some preferred embodiments, the injection tube, the return pipette and/or the delivery medium are made of a multi-layered composite material commonly used in minimally invasive interventions.

In some embodiments, a fixed bend or adjustable bend is provided at the distal portion of the injection system, or a hollow movable stop or articulation structure is provided at the distal portion of the injection system.

In some embodiments, the injection system is provided with a sheath having a fixed bend angle or a real time adjustable bend, the injection system being provided within the sheath.

Compared with the prior art, the beneficial effects of this application mainly appear:

1. according to the technical scheme provided by the application, the proximal end of the injection needle is in sealed connection with the suction tube and the distal end of the injection tube, an injection object is pre-loaded in the injection tube, and when the injection needle is inserted into target tissue in the operation process, the resistance of the suction power device to move towards the proximal end is large; when the injection needle is inserted into the cavity, the resistance of the suck-back power device to the near end movement is small, and the fluid in the cavity enters the suck-back tube, so that an operator can directly observe the position change of the suck-back power device relative to the system through naked eyes or experience the hand feeling resistance of the suck-back power device, the needle point position of the injection needle can be quickly judged, the needle inserting process before injection can be effectively monitored, the safety of the myocardial filling material injection at each subsequent time is ensured, and the problems of difficult selection of the needle inserting target point, difficult control of the needle inserting depth and the safety endangering the life of a patient caused by the fact that the myocardial filling material is injected into the cavity at a non-target point position by using a traditional injector in the operations such as myocardial injection filling and the like are solved.

2. The viscosity of the proper injection is 50-800 mPa.s, the injection has injectability in the injection tube with the inner diameter of 0.5-4 mm and the length of more than or equal to 200mm, but the fluidity is slightly poor, so that the injection can keep relatively static in the inner cavity of the injection tube, an operator can directly control the handle of the suck-back piston without additional auxiliary operation, the suck-back piston moves towards the near end, and the fluid in the cavity is ensured, but the injection in the injection tube does not enter the suck-back tube, and therefore the occurrence of misjudgment can be avoided.

3. The monitoring mechanism that this application set up for in the art person can judge whether effectively to prick target tissue by the needle point fast, the controllability to the target tissue depth of pricking of this system before the injection has been strengthened remarkably, improves the operational safety of this system greatly.

4. The observation component made of the light-transmitting material is convenient for an operator to directly observe the change of fluid contained in the observation component by eyes, because blood is usually red, under the condition that the injection loaded in the system is made of a colorless transparent material, when the myocardial minimally invasive injection filling operation of epicardium injection is carried out by adopting the injection material reaching the outer surface of the heart through an endoscope channel and the judgment of the effectiveness of the needle insertion is carried out, the operator directly observes or observes the color of the fluid contained in the observation component to turn red by means of endoscope light source equipment and the like through naked eyes, the injection needle penetrates through the whole ventricular wall to ensure that the needle point enters the ventricular cavity, or the needle point penetrates into blood vessels such as coronary artery and the like in the ventricular wall, the needle insertion depth is not ideal at the moment, the needle insertion depth of the injection needle needs to be adjusted, or other positions are reselected for the needle insertion, thus facilitating monitoring of needle insertion effectiveness prior to injection.

5. The first non-return mechanism is arranged in a valve type structure, so that the functions of injection and feeding of the system are not affected, and meanwhile, the liquid and the filler are conveniently and simply preloaded in the system.

6. This application is provided with hand switch formula valve structure respectively at the near-end of straw and the near-end of syringe to and the separating membrane that has microporous structure that this application provided, not only ensure that the art person judges the needle point position fast, still ensure that the injection process of every target position point goes on smoothly.

7. The utility model provides a feeding device, the injection has been held in the feeding device, make this system need not to withdraw from extracorporeally in the operation process, but carry out internal "normal position", carry out the loading material immediately, and then satisfy and use one set of injection system alright carry out single or many times feeding and the requirement of multiple injection in vivo fast, the number of times that the traditional syringe that significantly reduces withdraws from repeatedly and sends into human body or animal body, not only reduce the human body or animal body passageway tissue, for example, the mechanical damage risk of comparatively fragile vascular system tissue wall, still show and shorten whole operation time, reduce the operation risk.

8. The application provides the suck-back assembly and the injection assembly with various embodiments, which endow the channel access with excellent bending adaptability and dimensional compatibility, excellent torsion transferability and axial force transferability and good space controllability, are convenient for the system to adopt minimally invasive surgery and minimally invasive intervention operation to inject and fill target tissues, and are particularly suitable for myocardial minimally invasive injection and filling operation of achieving epicardial injection on the outer surface of a heart through an endoscopic channel.

Drawings

Fig. 1 is a schematic structural diagram of a first embodiment of the present application.

Fig. 2a to 2c are cross-sectional views a-a and B-B of fig. 1, wherein fig. 2a, 2B and 2c respectively show three different embodiments of the double lumen tubing arrangement.

Fig. 3a to 3e show the main operation principle of the injection system provided by the present application, wherein fig. 3a shows a state that the injection needle of the present injection system has penetrated through the entire ventricular wall and the needle tip enters into the ventricular cavity, fig. 3b shows a state when the needle insertion effectiveness is judged by pulling back the suction power device based on fig. 3a, fig. 3c shows a state that the needle tip of the present injection system is located in the blood vessel cavity such as coronary artery in the ventricular wall and the like and the needle insertion effectiveness is judged by pulling back the suction power device, fig. 3d shows a state that the needle tip of the present injection system enters into the target tissue, and fig. 3e shows a state when a target position point injection is performed "in situ" based on fig. 3 d.

Fig. 4a and 4b show the structure of the monitoring mechanism in the second embodiment of the present application in two embodiments.

Fig. 5 is a schematic structural diagram of a third embodiment of the present application.

Fig. 6a to 6c are schematic structural views illustrating a fourth embodiment of the present application, wherein fig. 6a is a state at an instant when the suck-back power device is ready to be moved to the proximal end for needle insertion validity determination; FIG. 6b is a view of the instant the suck back power unit of FIG. 6a is moved a distance proximally; figure 6c shows the situation when a targeted site injection is initiated.

Detailed Description

In order to make the objects, technical solutions and advantages of the present application more apparent, the present application is further described in detail below by referring to the accompanying drawings and examples.

To more clearly describe an injection system that is provided herein and that monitors the effectiveness of a needle insertion, the terms "proximal" and "distal" are defined herein, which terms are conventional in the medical device arts. Specifically, "proximal" refers to the end of the surgical procedure that is closer to the operator, and "distal" refers to the end of the surgical procedure that is further from the operator.

The first embodiment is as follows:

as shown in fig. 1 to 2c, the present application provides an injection system (hereinafter referred to as "the present system") capable of monitoring the effectiveness of a needle insertion, the present system includes an injection needle 1, a suck back assembly 2, an injection assembly 3 and an injectant 5, the injection needle 1 is disposed at the distal end of the present system and is fixedly connected with the distal end of the present system, the suck back assembly 2 includes a suck back tube 21 and a suck back power device 22, the lumen of the injection needle 1 is in fluid communication with the lumen of the suck back tube 21, the injection assembly 3 includes an injection tube 31 and an injection control device 32, the lumen of the injection needle 1 is in fluid communication with the lumen of the injection tube 31, the proximal end of the injection needle 1 forms a sealed connection with the suck back tube 21 and/or the distal end of the injection tube 31, the injectant 5 is preloaded in the injection tube 31, and the position of the injection needle 1 is judged by the movement resistance of the suck back power device 22 in the suck back tube 21. During operation, when the injection needle 1 is inserted into the target tissue 9, the resistance to proximal movement of the suck back motive means 22 is high; when the needle 1 is inserted into the channel 8, the resistance to proximal movement of the suck back motive means 22 is low and the fluid 81 in the channel 8 flows into the lumen of the needle 1 and finally into the suck back tube 21.

In order to achieve the function of fluid communication between the injection needle 1 and the three of the suction tube 21 and the injection tube 31, the present application has various embodiments from the design point of view, for example, in the first embodiment, as shown in fig. 1 to 5, the proximal end of the injection needle 1 is first connected to the distal end of the injection tube 31 in a sealing manner, and communication ports 20 are provided at the distal end regions 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 second embodiment, the proximal end of the injection needle 1 is first sealingly connected to the distal end of the return straw 21, and a communication port 20 is provided at the distal end regions of the injection tube 31 and the return straw 21, so that the lumen of the injection tube 31 and the lumen of the return straw 21 are in fluid communication. In a third embodiment, as shown in fig. 6a to 6c, a connection cavity 4 is provided at the distal ends of the suction tube 21 and the injection tube 31, the connection cavity 4 has a certain length in the axial direction, and the connection cavity 4 is hermetically connected with the injection needle 1, so that the inner cavity of the injection needle 1 is respectively in fluid communication with the inner cavity of the suction tube 21 and the inner cavity of the injection tube 31.

For the sake of convenience and economy of manufacture, and considering the functional effectiveness of the fluid communication between the injection needle 1 and the three components, namely the return straw 21 and the injection tube 31, the connection and communication between the three components can be achieved by the following two methods, and in a first embodiment, the manufacturing method comprises the following steps:

① selecting medical single lumen tube with proper size and hardness as the injection tube 31 and the suction tube 21, wherein the injection tube 31 and the suction tube 21 are two independent lumen tubes;

② respectively forming openings at the distal end regions of the injection tube 31 and the suction tube 21 by grooving, perforating or heating end molding on the tube wall side of the distal end regions, wherein the two openings are oppositely arranged and the optimal shape is that the boundaries of the opening regions are just matched;

③ selecting medical grade material, suitable size and hardness tube as raw material of sealing tube, the inner cavity of the sealing tube should be capable of accommodating the injection tube 31 and the suction tube 21 simultaneously, so as to hold the injection tube 31 and the suction tube 21 tightly as the best shape;

④ fitting the sealing tube over 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 should be greater than that of the opening area, so that there is a sufficient length of sealing connection area between the sealing tube and the injection tube 31 and the suction tube 21 outside the opening area;

⑤, the sealing tube is sealingly connected to the injection tube 31 and the return straw 21 by a suitable sealing connection method, an alternative sealing connection method comprises a) injecting an adhesive into the gap between the sealing tube and the injection tube 31 and the return straw 21, the adhesive including but not limited To Polyurethane (TPU) solution, fluorinated ethylene propylene copolymer (FEP) emulsion, glue Loctite3011, 3321, 3493, 3494, 3751, 4011, 4013, EA M-31CL, Dyglue max203a-cth-f, 204-cth-f, 1201-M-sc, 1128a-M, glue NuSil MED-2000P, glue Dow Corning SILASTIC MEDICAL ADHESIVE, TYPEA; b) heating melt or ultrasonic welding, the three directly melt the three, achieving the function of removing the sealing tube end face and the sealing connection, and the double effect of sealing connection performance, the SILICONE, TYPEA, b) opening the injection tube 31 and the return straw 21 to enable the fluid connection.

⑥ selecting medical grade material, suitable size and high hardness tube as the injection needle 1, cutting, grinding, polishing and the like the distal end of the injection needle 1 to form a certain inclined cutting angle on the distal end surface, and connecting the proximal end area of the injection needle 1 and the outer surface of the needle tube by welding, bonding, melting and the like to form a connecting block according to the requirement of connection firmness, wherein 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 return suction tube 21, or close to the sum of the inner diameter of the injection tube 31 and the inner diameter of the return suction tube 21, so as to form a more stable and effective connection between the injection needle 1 and the injection tube 31 and/or the return suction tube 21, avoid the huge difference of performance caused by the completely different materials between the injection needle 1, which is usually made of metal, and the injection tube 31 and the return suction tube 21, which are usually made of polymer, which can not be connected firmly, so that the injection needle 1, the injection tube 31 and the return suction tube 21 move relatively to cause the falling of the patient, and the patient may be threatened to fall off in the safety of the patient;

⑦, the proximal region of the needle 1 is connected to the syringe 31 and/or the pipette 21 in a sealing and fixed manner by means of the above-mentioned connecting piece.

In a second embodiment, the manufacturing method comprises the steps of:

① A-A in FIGS. 2a, 2b and 2c, the preferred embodiment is shown in FIGS. 2a, 2b and 2c, wherein the double lumen tubing is a medical grade tubing, and the injection tube 31 and the suction tube 21 are an integral double lumen tube, and the shape of the double lumen tube is designed to take into account the fact that components that may be connected to or assembled with the double lumen tube and move relative to each other, such as the size of the lumen of the bending sheath, the size of the lumen of the sheath, the size of the access, such as the lumen of the sheath or the sheath, and the size of the open area of the lumen, such as the lumen or the chest, may be designed outside the system, and at the same time, the cross-sectional shape of the double lumen tube is designed to take into account the various properties that may be required for clinical procedures, such as pushability, compliance for access to the surgical access, and compliance to bend when performing bending operations on the external bending sheath.

② an opening is formed inside the double lumen tube by post-machining, such as grooving, perforating, etc., the distal region of the side wall common to the syringe 31 and the return straw 21, as shown in fig. 2a, 2B and B-B of fig. 2c, said opening forming the communication port 20 or the connecting lumen 4 to allow fluid communication between the lumen of the syringe 31 and the lumen of the return straw 21.

③ the remaining steps can be performed as described above with reference to steps ③ to ⑦ of the first embodiment.

The suck back power device 22 of the present system comprises a power source 223 and a transmission medium 221, wherein the power source 223 is disposed outside the proximal end of the suck back tube 21, the transmission medium 221 is at least partially located in the inner cavity of the suck back tube 21, and the transmission medium 221 can move along the inner cavity of the suck back tube 21. In some embodiments, the power source 223 is provided directly by the operator, and the transmission medium 221 is one or a combination of a liquid and a solid.

In this embodiment, the transmission medium 221 is a solid, and preferably, the solid is a rod or a pipe. Further, the suck-back power device 22 further includes a suck-back piston 220, the suck-back piston 220 is in sliding sealing fit with the suck-back pipe 21, and a proximal end surface of the suck-back piston 220 is always in contact with and connected to the transmission medium 221 in the form of the rod or the pipe, and the power source 223 can drive the transmission medium 221 and the suck-back piston 220 to move in the inner cavity of the suck-back pipe 21. Preferably, the rod or the tube is fixedly connected or connected in a limiting manner with the suck-back piston 220. The rod body or the tube body can not generate axial tension and compression deformation, and has good axial tension transmissibility and mechanical instant responsiveness, so that in clinical use, an operator as the power source 223 applies certain tension to the rod body or the tube body when operating the proximal end area of the rod body or the tube body or operating the suckback piston handle 222 fixedly connected with the proximal end of the rod body or the tube body, so that the rod body or the tube body is moved in the suckback tube 21, the distal end of the rod body or the tube body and the suckback piston 220 can obtain the tension very timely, and the operator can timely sense or directly observe whether the distal end of the transmission medium 221 relatively moves in the inner cavity of the suckback tube 21 and make a quick judgment. Preferably, the length of the rod or tube is greater than the length of the return straw 21, so that the proximal end of the rod or tube is always located outside the proximal end of the system. The proximal end of the rod body or tube body is provided with a suck-back piston handle 222 fixedly connected with the rod body or tube body, so that the hand feeling comfort degree of an operator when operating the system can be enhanced.

As mentioned above, the injection assembly 3 comprises the injection tube 31 and the injection control device 32, the injection control device 32 can be designed with reference to the above-mentioned suck-back power device 22, specifically, in this embodiment, the injection control device 32 comprises an injection piston 320 located in the inner cavity of the injection tube 31, an injection piston rod 321 fixedly or limitedly connected to the proximal end of the injection piston 320, and an injection piston handle 322 always located outside the proximal end of the injection tube 31 and fixedly connected to the injection piston rod 321, the injection piston 320 is in sliding sealing fit with the inner cavity of the injection tube 31, preferably, the injection piston rod 321 is solid, specifically, can be a rod body or a tube body, the injection piston rod 321 is not subjected to axial tension and compression deformation, and has good axial tension transferability and mechanical immediate responsiveness, therefore, the design is such that in clinical use, when the operator who is the power source provider operates the injection piston handle 322, for example, applies a certain pushing force to the injection piston rod 321 to move it a certain distance in the distal direction at a certain speed, the injection piston 320 can obtain the pushing force in a very timely manner and move it an equivalent distance at the same speed, so as to ensure that the movement of the whole injection control device 32 relative to the injection tube 12 is completely synchronized, so that the injectate 5 that has been pre-loaded in the injection tube 31 can be injected from the injection needle 1 at a certain uniform speed in the distal direction, and the volume of the injectate 5 that is injected is exactly equal to the volume defined by the space in which the injection piston 320 moves in the injection tube 31, when the marker line 74 showing volume scale marks is provided on the injection tube 31 and/or the injection piston rod 321, as shown in fig. 6a to 6c, the operator can directly observe the change of the injection process by naked eyes, so as to achieve the precise control of the injection speed and the total injection amount of the injectate 5.

As shown in fig. 3e, the present system is used to safely inject the injectate 5, particularly various tissue engineering materials, into the interior of target tissue 9, the target tissue 9 having the physical characteristics of an edge profile, having a lumen 8 outside the target tissue 9, the lumen 8 being a tissue or organ capable of containing or being filled with a fluid 81, the fluid 81 is a substance flowable in a tissue or organ of a human or animal body, the fluid 81 comprises interstitial fluid in the human or animal body, gas in the respiratory system, and preferably, the target tissue 9 comprises a ventricular wall, an atrial wall, a ventricular septum, an atrial septum and a vessel wall, the cavity channel 8 comprises a ventricular cavity, an atrial cavity, an auricle cavity and a vessel cavity, correspondingly, the tissue fluid is blood in a human body or an animal body, and the system is used for cardiac minimally invasive surgery or cardiac minimally invasive intervention.

When the system adopts the minimally invasive cardiac surgery or minimally invasive cardiac interventional surgery to inject and fill target tissues, such as cardiac muscle of the left ventricular wall, the suction tube 21, the transmission medium 221, the injection tube 31 and the injection piston rod 321 in the system are preferably made of solid materials which can be bent but not be stretched or compressed so as to provide sufficient bending adaptability, torsion transmissibility and axial force transmissibility, and in consideration of the length and size of the surgical access, the axial length of the suction tube 21, the transmission medium 221, the injection tube 31 and the injection piston rod 321 in the system should be 50mm to 2000mm, and the maximum size of the outer diameter is less than or equal to 5mm, and the system ensures excellent bending adaptability and size compatibility to the access so as to adapt to the internal channel of the endoscope or the cardiovascular system of the in vivo tortuosity, ensuring effective access to target tissue, e.g., a lesion site. In addition, the system can rotate circularly around the central axis of the system and swing in the endoscope or the wound protector for multiple times in the operation process, so that target injection of dozens of points is performed in the free wall area of the cardiac ventricle wall, and the excellent torsion transmissibility and the axial force transmissibility of the system enable the system to have good space controllability (including the controllability such as the positioning of a three-dimensional space) and are convenient to use in cardiac minimally invasive surgery or cardiac minimally invasive interventional surgery.

In this regard, the solid material is preferably a flexible material or an elastic material, and includes: the injection needle is characterized in that the injection needle 1 is made of a solid material which can be bent and deformed but can not be stretched or compressed, the injection needle 1 is a microneedle, and the cross sectional area of an inner cavity of the microneedle is S0 ∈ [0.008mm2, 0.3mm2 ]; in one embodiment, the suction tube 21 and the injection tube 31 are made of multiple medical materials commonly used in medical minimally invasive interventions through a certain connection process to form a multi-layer composite material (e.g., a three-layer composite tube with a woven mesh tube as an intermediate layer, a three-layer composite tube with a coil spring tube as an intermediate layer, etc.), and in another embodiment, a fixed bent section or an adjustable bent section is disposed at a distal end portion of the suction tube 21 and the injection tube 31, and a hollow movable limiting structure or an articulated connection structure may also be disposed. The system can optionally also be provided with a sheath with a fixed bend angle or a real time adjustable bend, inside which the return straw 21, the injection tube 31 and the injection needle 1 are arranged. For the suck-back piston 220 and the injection piston 320, they should be made of high molecular material with elasticity and shape recovery, such as silicone, rubber, silicone rubber, polyurethane, polyether block amide, polyolefin elastomer, etc., in one embodiment, the suck-back piston 220, the injection piston 320, the rod body or tube body and the injection piston rod 321 are made of material with surface friction coefficient less than or equal to 0.3, including but not limited to Polyoxymethylene (POM), Polytetrafluoroethylene (PTFE), Fluorinated Ethylene Propylene (FEP), High Density Polyethylene (HDPE), Ultra High Molecular Weight Polyethylene (UHMWPE); in another preferred embodiment, the outer surfaces of the suck-back piston 220, the injection piston 320, the transmission medium 220 and the injection piston rod 321 are provided with material coatings or coatings with surface friction coefficient less than 0.3, and the friction between the outer surfaces of the suck-back piston 220, 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 can be significantly reduced by the coatings or coatings, so that the operation hand feeling of the system is improved, the manufacturing cost is low, and the material selection cannot be influenced, therefore, the system is suitable for injecting the injectate 5 with different viscosities or performing in vivo injection with long injection stroke and tortuous injection path.

The injectate 5 loaded in the injection tube 31 is flowable before being injected into the target tissue 9, has a moderate viscosity, and the flow performance of the injectate 5 is good when the viscosity is between 5mPa · s and 1000mPa · s, which not only enables the injectate 5 loaded in the present system to flow in a distal direction under the driving of the injection control device 32 and finally to be injected from the needle tip 11 of the injection needle 1, as shown in fig. 3e, but also enables the injectate 5 located between the needle tip 11 and the distal end of the pipette return tube 21 in the cavity of the present system to flow in a proximal direction, so that the pipette return power device 22 can function, specifically, taking myocardial injection filling as an example, when the needle tip 11 of the injection needle 1 is inserted into the cavity 8, the method comprises the following steps: the injection needle 1 shown in fig. 3a and 3b penetrates the entire ventricular wall 91 so that the needle point 11 enters the ventricular cavity 82, the injection needle 1 shown in fig. 3c is in the ventricular wall 91 but the needle point 11 is in the vascular cavity 83 such as coronary artery in the ventricular wall 91, the needle point of the injection needle 1 is not in the myocardium of the ventricular wall 91 although the injection operation is performed, the operator can easily operate the suck-back power device 22 to move the transmission medium 221 in the proximal direction of the suck-back tube 21 with small moving resistance, the fluid 81 (i.e., blood) in the lumen 8 enters the suck-back tube 21, as shown in fig. 3b and 3c, at this time, the operator directly sees the position change of the suck-back power device 22 relative to the system through naked eyes or the feeling resistance of the suck-back power device 22 through the naked eyes, the correct judgment that the needle point 11 of the injection needle 1 is not inserted into the cardiac muscle but inserted into the blood vessel on the cardiac wall, or penetrates through the ventricular wall 91 and is inserted into the ventricular cavity, or the injection needle 1 is not inserted can be quickly judged, so that the correct judgment that the needle point 11 is not positioned in the target tissue 9 can be easily made, the needle inserting process before injection can be effectively monitored, and the safety of the injection of the myocardial filling material at each subsequent time can be ensured, and therefore, the problems of difficult selection of the needle inserting target point, difficult control of the needle inserting depth and the safety endangering the life of a patient caused by the fact that the myocardial filling material is injected into the cavity 8 at the position which is not the target point by using a traditional injector in the operations such as myocardial injection and filling and the like are solved.

The injection 5 applicable to the present application can relate to various myocardial filling materials, prosthesis filling materials and tissue treatment materials, including cellulose derivative gel, xyloglucan gel, chitosan-based gel, alginic acid-based gel, chitin gel, acrylic acid-based gel and derivative gel thereof, polyglycolic acid, polylactic acid and copolymer thereof, polycaprolactone, polyhydroxyalkanoate, silk fibroin, polyanhydride, extracellular matrix (ECM), various stem cells, various growth factors, fine magnetic beads, magnetic powder and the like. Preferably, the injectate 5 also has self-curing or self-gelling properties, and the injectate 5 is a self-curing or self-gelling material, and the operator can select a material with a suitable self-curing or self-gelling time according to the clinical practical requirements, such as the total time required from mixing before loading into the inner cavity of the injection tube 31 until injecting into the target tissue 9, in some embodiments, the self-curing or self-gelling time of the self-curing or self-gelling material should be less than or equal to 30min, and in a more preferred embodiment, the self-curing or self-gelling time should be in the range of 0.5min to 15 min. In summary, the self-curing or self-gelling material should complete the self-curing or self-gelling process in a timely manner to shorten the operation time and reduce the potential risk of the operation, and after the self-curing or self-gelling material is injected into the target tissue 9, the self-curing or self-gelling material starts to self-cure or self-gelling rapidly, so that the self-curing or self-gelling material in a single injection target site has a certain cohesion to form a whole and is retained in the target tissue 9, and the injected self-curing or self-gelling material does not leak along the outflow of the pinhole channel gap formed in the ventricular wall 91 after the injection needle 1 is withdrawn, thereby affecting the safety and effectiveness of the operation.

The system is suitable for monitoring the effectiveness of the needle inserting process before injection, and then injection is carried out, so that the injection safety is ensured. As shown in fig. 3a to 3e, when the operator performs a minimally invasive myocardial injection and filling operation and selects a gel with self-coagulation property as the injectate 5, the main working principle of the system is as follows:

1. outside the body, the suck back piston handle 222 is operated to push the suck back piston 220 to the distal region ensuring that the suck back piston 220 effectively blocks the communication port 20. If necessary, the operator holds the suck-back piston handle 222 still or the suck-back piston handle 222 and the suck-back tube 21 are connected to each other, so as to keep the suck-back piston 220 still in position relative to the communication port 20, and then slightly pushes the injection piston handle 322, so that the flowable injectate 5 loaded in the injection tube 31 moves towards the distal end to fill the cavity of the injection needle 1 with the injectate 5, thereby achieving the purpose of exhausting 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 position of the injection piston 320 in the cavity of the injection tube 31 is kept still by holding the injection piston handle 322 still by an operator or keeping the connection of a detachable connection structure arranged between the injection piston handle 322 and the injection tube 31. The system and possibly the parts of the fixation bend sheath or the bending sheath assembled with the outside of the system are introduced into the body along a specific path, such as a vascular sheath, an endoscopic sheath, etc. which are already in place in advance, so that the injection needle 1 reaches the left ventricle cavity of the heart or the region of the external surface of the left ventricle.

3. The operator can choose the position of the needle insertion on the inner cavity surface or the outer surface of the heart in the left ventricle area at will, and can try the needle insertion with different needle insertion depths at will, at this time, one of the following two main situations can occur:

i) ① the needle 1 shown in fig. 3a and 3b penetrates the entire ventricular wall 91 so that the needle tip 11 enters the ventricular cavity 82, ② the needle 1 shown in fig. 3c is inside the ventricular wall 91 but the needle tip 11 is inside the vascular cavity 83 such as coronary artery in the ventricular wall 91, ③ the operator has performed the puncturing operation but the entire needle 1 has not come into contact with the ventricular wall 91, in all three cases the operator can easily manipulate the retraction piston handle 222 to move the retraction piston 220 towards the proximal end with little resistance to proximal movement, the fluid 81 (i.e. blood) in the lumen 8 is easily retracted into the retraction tube 21 as shown in fig. 3b and 3c, when the operator experiences the resistance of the retraction motor 22 directly against the position of the system or experiences the resistance of the retraction motor 22 to the needle tip 11, and even if the needle tip 5 is not in contact with the target tissue, the effectiveness of the needle can be judged to be reduced, and the needle can be used to prevent the target tissue from being injected directly into the target tissue 5.

ii) as shown in fig. 3d, when the needle tip 1 is inserted into the target tissue 9, the target tissue 9 is soft tissue but not fluid, so the pipette 21 of the present system cannot be in fluid communication with the target tissue 9 in the region outside the needle tip 1, once the operator tries to pull back the pipette plunger handle 222 and tries to move the pipette plunger 220 towards the proximal end, a negative pressure space is formed in the region of the pipette plunger 220 and the injection plunger 320 and the needle tip 1 in the present system, and the target tissue 9 is derived from the tissue or organ of the human or animal body and is connected with the tissue or organ, and the needle 1 of the present system is selected as a microneedle which makes the present system more minimally invasive, and has a small lumen cross-sectional area S0, such as S0 ∈ [0.008mm2, 0.3mm2], so the target tissue 9 is not sucked back into the present system, therefore, the resistance of the suck-back power device 22 to move towards the proximal end is large, even the operator cannot move the suck-back piston handle 222 towards the proximal end, and at this time, the operator can quickly make a correct judgment that the needle point 11 is located in the target tissue 9, and the needle insertion is effective at this time.

In summary, the operator can use the system provided in the present application to try to pull back the retraction piston handle 222 at any time during the needle insertion process before injection, if the retraction piston handle cannot be pulled back, it indicates that the needle tip 11 is inserted into the target tissue 9, and if the retraction piston handle can be pulled back, it indicates that the needle tip 11 is not inserted into the target tissue 9 but enters a non-target tissue region, especially the lumen 8, so that the effectiveness monitoring and correct judgment of the needle insertion process before injection can be easily and quickly achieved.

It is worth noting that the greater the viscosity of the injectate 5, the lower its flowability. After a large number of exploratory experiments, we found that: when the viscosity of the injectate 5 is 50-800 mPa · s, the injectate 5 has injectability in the injection tube 31 with the inner diameter of 0.5-4 mm and the length of 200mm or more, but has poor fluidity, so that the injectate 5 can spontaneously keep relatively static in the inner cavity of the injection tube 31, which is convenient for an operator to directly operate the suck-back piston handle 222 to move the suck-back piston 220 towards the proximal end without holding the injection piston handle 322 immovably relative to the injection tube 31 or providing a detachable connection structure between the injection piston handle 322 and the injection tube 31 to connect the injection piston 320 in the position in the cavity of the injection tube 31, so as to ensure that the fluid 81 in the cavity 8 instead of the injectate 5 in the injection tube 31 enters the suck-back tube 21, therefore, the occurrence of the phenomenon that the needle insertion cannot be determined to be effective, namely, the phenomenon that the correct judgment cannot be carried out can be avoided.

4. After the judgment of the effectiveness of the needle insertion is made and the needle insertion is ensured to be effective, the operator can keep the needle point 11 at the needle insertion position, i.e. the depth of the needle insertion in the ventricular wall 91 is constant, and then an injection of one targeted site is performed "in situ", for example, holding the proximal end region of the injection tube 31, moving the injection piston handle 322 together with the injection piston rod 321 in the distal direction at a certain speed and a certain distance, the injectate 5 loaded in the injection tube 31 will be injected out of the injection needle 1 and into the target tissue 9 at a certain injection speed, as shown in fig. 3e, the total injection amount of the injectate 5 loaded in the syringe 31 injected from the injection needle 1 is precisely controlled by the volume scale or the like provided on the injection unit 3, i.e., the mark line 74.

During injection, the process of the injectate 5 flowing towards the proximal end causes the suck-back piston 220 at the communication port 20 to be under a certain pressure, and if the pressure direction is perpendicular to the central axis of the suck-back piston 220, the position of the suck-back piston 220 in the system will remain unchanged, which can ensure the smooth injection process, and for this purpose, the suck-back piston 220 should be configured as one or more combinations of a cylinder, a saddle, and a bead, which can rotate along the central axis of the suck-back tube 21. Of course, for safety, the operator may also take enhanced measures, such as holding the suck-back piston handle 222 still, or a detachable connection structure between the suck-back piston handle 222 and the suck-back tube 21, so as to keep the suck-back piston 220 still with respect to the communication port 20.

5. After injection at one target site is performed, other needle inserting positions can be selected according to the requirement of effectiveness of the operation, the

steps

3 and 4 are repeated, secondary and multiple times of needle inserting effectiveness monitoring and judgment and secondary and multiple times of target site injection are carried out until the total amount of all the injection substances 5 injected into the target tissue 9 reaches the total amount of the whole operation, and finally the injection is 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 further includes a monitoring mechanism 7, so as to enhance the correctness of the effectiveness judgment of the needle insertion of the injection needle 1 by the operator using the system, and improve the reliability of the effectiveness judgment. The monitoring means 7 can be realized in various embodiments.

In a first embodiment, the monitoring means 7 is a monitoring chip 71 disposed in the distal portion of the system, as shown in fig. 4a, the monitoring chip 71 can generate one or more warning signals for blood, so that the monitoring chip 71 can contain a detection reagent for identifying certain components in blood, an indicator or test paper for color change in blood, a luminescent reagent for emitting light when blood is encountered, and a sensor for sensing certain components in blood or blood pressure. The monitoring chip 71 may be embedded in the wall of the distal region of the system or directly placed in the cavity of the distal region of the system in a shape of a sheet, a ring, a dot, or the like, may be fixedly connected to the needle tip 11 of the injection needle 11 in a shape of a ring, a dot, or the like, or may be embedded in the wall or the cavity of the injection needle 11 in a shape of a line, a tube, or the like. If the operator tries to operate the suck-back piston handle 222 during or after the needle insertion, and tries to move the suck-back piston 220 proximally, it is found that the detection chip 71 generates any one of the above warning signals, which indicates that the needle tip 11 or the detection chip 71 is in contact with blood, so that the operator can make a correct judgment that the needle tip 11 is not located in the target tissue 9.

In a second embodiment, the monitoring mechanism 7 is a monitoring mark 72 disposed on the injection needle 1, and fig. 4b shows that the monitoring mark 72 is located on the needle tip 11 of the injection needle 1, when the system is used for needle insertion before injection in minimally invasive surgery and minimally invasive interventional surgery, visualization can be achieved by means of a medical imaging device connected to a computer screen, such as an X-ray machine, an ultrasonic image diagnostic device, etc., so as to assist an operator to determine the position of the injection needle 1 in the ventricular wall 91, for which, the monitoring mark 72 may be fixedly connected to the needle tip 11 in a ring shape, a dot shape, etc., or embedded in the wall of the injection needle 1 in a line shape, a tube shape, etc., and the material suitable for the monitoring mark 72 should have X-ray or ultrasonic developability, including but not limited to tantalum, platinum, iridium, platinum alloy, iridium alloy, and platinum alloy, etc, Metals such as cobalt, chromium, cobalt-chromium alloy, osmium, tungsten, rhodium, gold, palladium, rhenium, stainless steel, etc., or compounds such as barium sulfate, bismuth subcarbonate, bismuth oxychloride, zirconium oxide, bismuth oxide, titanium oxide, niobium oxide, etc., are added. In particular, in order to further enhance the real-time monitoring of the entire insertion procedure of the injection needle 1 into the ventricular wall 91, so that the needle tip 11 is located in the ventricular wall 91 without piercing, and a desired insertion depth is achieved, and the operation procedure is sufficiently safe, the distal region of the system, in particular the injection needle 1, should be made of a material which can be monitored and observed by the ultrasound image diagnostic equipment, preferably a medical metal material having a large density difference with the myocardial tissue, such as nitinol, 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 a viewing component 73 made of a material with light transmittance, as shown in fig. 6b, the viewing component 72 can be disposed at any position of the distal region of the system, including the region of the connection cavity 4 and the distal portions of the suction tube 21 and the injection tube 31, the viewing component 72 can be embedded in the tube wall of the system, and can also be used as a structural component fixedly and hermetically connected with the proximal end of the injection needle 1, the suction tube 21 and the distal end of the injection tube 31, so that the length of the viewing component 72 is sufficient for the operator to directly observe the inside of the system with eyes, for example, 0.5mm or more; when the whole areas of the suction tube 21, the injection tube 31 and the connection cavity 4 are made of transparent materials, the areas become the observation part 73, so that the operator has a wider observation field, and the color change of the fluid contained in the system can be conveniently observed by means of a medical optical system, such as an endoscope and the like. In particular, since blood is usually red, in the case that the observation unit 73 and the injectate 5 loaded in the system are both made of colorless transparent materials, when the operator performs a minimally invasive myocardial injection filling operation that epicardial injection is performed by reaching the outer surface of the heart through an endoscopic channel and determines the effectiveness of the needle insertion, the color of the fluid contained in the system is red by direct observation or observation through means such as an endoscopic light source device, the same indicates that the needle 1 penetrates the entire ventricular wall 91 so that the needle tip 11 enters the ventricular cavity 82, or the needle tip 11 penetrates the vascular cavity 83 such as coronary artery in the ventricular wall 91, and the needle insertion depth is not ideal, and the needle insertion depth of the needle 1 needs to be adjusted, or the position of the needle insertion target is not ideal, and other positions should be selected for needle insertion, until the needle insertion is effective.

In a word, the arrangement of the monitoring mechanism 7 enables an operator to quickly and correctly judge whether the needle tip 11 of the injection needle 1 is effectively inserted into the target tissue 9, so that the controllability of the insertion depth of the target tissue 9 before injection of the system is obviously enhanced, and the operation safety of the system is greatly improved.

Example three:

based on the first embodiment, the third embodiment is different from the first embodiment in that the power source 223 of the suck-back power device 22 is a pump disposed outside the suck-back pipe 21, and the transmission medium 221 is a liquid, as shown in fig. 5. Specifically, the pump may be provided with an extension tube, the distal end of the suction tube 21 and the proximal end of the extension tube may be respectively provided with a connector 25 with a detachable connection structure, so as to detachably connect the suction tube 21 and the extension tube, the whole interior of the suction tube 21 and the interior of the extension tube may be pre-loaded with the liquid, the distal end of the liquid may be located at the communication port 20 and form a liquid-liquid interface with the injection liquid 5 pre-loaded in the injection tube 31, no air or air bubbles are left between the liquid and the injection liquid 5, which enables force transmission between the communication port 20 and the pump through the liquid, when the needle puncturing effectiveness is judged by using the present system, the pump is connected to a power source to generate a suction power source, the pump can suck back the liquid, when the needle point 11 is inserted into the cavity 8, the liquid can easily move towards the proximal direction along the inner cavity of the suction tube 21 and is sucked back into the pump, so that an operator can conveniently observe the liquid suction phenomenon through naked eyes, and the judgment is more facilitated. Of course, any position between the communication port 20 and the pump in the system may be further provided with a pressure monitoring meter 75, so that the operator can directly observe the pressure change of the liquid, and if a certain pressure value is displayed, the operator can also assist in judging that the needle tip 11 is inserted into the cavity 8.

The liquid is preferably heparin saline, physiological saline, contrast solution, water for sterile injection, and other liquids commonly used in interventional operations, and the use of liquid as the transmission medium 221 has more outstanding advantages compared with the first embodiment, including: a) in the process of minimally invasive interventional surgery through a cardiovascular system or through a natural orifice, when a rod body or a pipe body is used as the transmission medium 221, and an injection system passes through a tortuous blood vessel or a natural orifice in a body, the suction pipe 21 and the transmission medium 221 are in a bending state at the same time, the rod body or the pipe body is pulled back, the rod body or the pipe body tends to touch the inner wall of the suction pipe 21, so that the two generate larger friction, the pulling back resistance is larger if the pulling back resistance is larger, the operation hand feeling of the system is influenced, the rod body or the pipe body cannot move in the suction pipe 21 if the rod body or the pipe body is heavy, and the suction pipe cannot suck back to cause misjudgment, but the implementation mode can avoid the occurrence of the situation, has no hardness of liquid, can be bent or matched with a tortuous passage in the body in an abnormal and prominent manner, and reduces mechanical damage caused by friction on the inner wall tissue of the blood vessel or the, the advantage is exactly needed for minimally invasive intervention; b) the power provided by the pump is non-manual, and the operation comfort level is high; c) the advantage of a liquid having a very small volume change under pressure is that it ensures a sufficiently high force transmission efficiency and mechanical responsiveness for the transmission of force between the communication port 20 and the pump through the liquid. Of course, in order to maximize the efficiency of the fluid in transferring force, the area of the system chamber between the communication port 20 and the pump, as well as the portion of the pump containing fluid, should be sealed.

The second difference is that the injection control device 32 includes a feeding device 323, the feeding device 323 contains the injectate 5, and a detachable interface 35 is respectively disposed at the distal end of the feeding device 323 and the proximal end of the injection tube 31 to facilitate the detachable connection therebetween. The feeding device 323 can refer to the injection control device 32 in the first embodiment, the feeding device 323 is configured to facilitate the surgeon to feed the system in time, when feeding, the feeding device 323 is connected to the injection tube, the surgeon pushes the injection piston rod 321 as shown in fig. 6a, the injection 5 contained in the feeding device 323 is filled into the injection tube 31 to perform two or more target injections, until the total amount of the injection 5 injected into the target tissue 9 reaches the predetermined amount for the whole operation, so as to ensure the effectiveness of clinical injection. The material supplementing ensures that the system can load materials in situ and in time in vivo without withdrawing the body in the operation process, thereby meeting the requirements of quickly loading the materials and injecting the materials for one time or multiple times in vivo by using one set of injection system, greatly reducing the times of repeatedly withdrawing and sending the traditional injector into the human body or the animal body, not only reducing the risk of mechanical damage to the channel tissues of the human body or the animal body, but also obviously shortening the whole operation time and reducing the operation risk.

A third difference is that the injection assembly 3 further includes a first check mechanism 33 disposed inside the injection tube 31, and the first check mechanism 33 is an automatic on-off valve structure. Such an automatically opening and closing valve structure may be a valve structure 332 consisting of one or more check valve leaflets, fig. 5 showing that the valve structure 332 consists of two check valve leaflets that automatically open when the valve structure is subjected to pressure from the proximal to distal direction of the injection tube 31 and close when the valve structure is subjected to pressure from the distal to proximal direction of the injection tube 31, which ensures that the injection and feeding functions of the system are not affected, and that, when pre-loaded with liquid, the pump is operated to release the liquid, which flows and fills the interior of the extension tube, the interior of the suction tube 21, the communication port 20, and then the check valve leaflets will be subjected to pressure from the distal to proximal direction, so that the check valve leaflets close, ensuring that the liquid fills the needle interior and the interior of the needle 1, and then the pump operation is stopped, the liquid loaded inside the extension tube and the return tube 21 can remain relatively stationary, the injectate 5 is preloaded, the injectate 5 is added from the proximal end of the syringe tube 31, the valve-like structure is pressurized from the proximal to distal direction from the loading tube 31, the check valve leaflets open, and the liquid in the needle 1 will be expelled from the needle tip 11 by the injectate 5, and finally assumes the preloaded state as shown in fig. 5, thus facilitating the simple and rapid preloading of the liquid and the filler in the present system.

Example four:

as shown in fig. 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 hermetically connected with both the suction tube 21 and the distal end of the injection tube 31, and for this connection, a connection cavity 4 is provided at the connection point of the injection needle 1 with the suction tube 21 and the injection tube 31, and the connection cavity 4 has a certain length in the axial direction such 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. The system is characterized in that the area of the connecting cavity 4 is made of a material with light transmittance to form an observation part 73, so that an operator can directly observe the change of fluid contained in the area by eyes, such as the change of the color of the fluid, because blood generally shows red, under the condition that the injectate 5 loaded in the system is made of a colorless transparent material, when the myocardial minimally invasive injection filling operation of epicardial injection is carried out by reaching the outer surface of the heart through an endoscope channel, the operator directly observes or observes the color of the fluid contained in the connecting cavity 4 to turn red by means of endoscope light source equipment and the like when the effectiveness of the puncture is judged, the operator punctures the whole ventricular wall 91 through the injection needle 1 so that the needle tip 11 enters the ventricular cavity 82 or the needle tip 11 punctures the blood vessel cavity 83 such as coronary artery in the ventricular wall 91, in this case, the depth of the needle insertion is not ideal, and the needle insertion depth of the needle 1 needs to be adjusted or another position needs to be selected again for needle insertion, so that the effectiveness of needle insertion before injection can be monitored conveniently.

A second difference is that a separation membrane 6 is provided at the communication port 20 or the connection chamber 4, and fig. 6a to 6c show that the separation membrane 6 is provided at the connection chamber 4, the separation membrane 6 spans the whole communication port 20 or the connection chamber 4, and structurally, the separation membrane 6 has a microporous structure including micropores having a size suitable for allowing the liquid loaded in the lumen of the pipette 21 as the transfer medium 221 and the fluid 81, such as blood, sucked back from the channel 8 into the system to pass through the separation membrane 6, while the injectate 5 loaded in the lumen of the injection tube 31 cannot pass through the separation membrane 6, on the premise that the sensitivity of the system for monitoring the effectiveness of the needle insertion and the reliability of making a correct judgment therewith can be improved, and the separation membrane 6 can be provided in the lumen of the whole injection needle 1, The connecting chamber 4 and the entire suction tube 21 are pre-filled with a liquid as a driving medium 221, as shown in fig. 6a, and the liquid is preferably selected from substances that are difficult to mix with the injectate 5, do not cause any physical or biochemical reaction, and do not affect the performance of the injectate 5, such as physiological saline and sterile water for injection, and these designs have the following advantages: as shown in fig. 6c, the monitoring and determining of the needle insertion effectiveness is timely and correct, so that after the needle insertion effectiveness is determined and the needle insertion is ensured to be effective, the operator can easily operate the injection control device 32, so that the injectate 5 can only flow towards the distal direction to reach the injection needle 1, and finally the injectate enters the target tissue, but the injectate 5 does not flow into the suction tube 21, thereby ensuring that the subsequent injection process is performed smoothly.

A third difference is that the first backstop mechanism 33 is disposed on the proximal end of the syringe 31 and can be sealingly connected to the syringe 31. The suck back assembly 2 further comprises a second backstop mechanism 23 disposed on the proximal end of the suck back tube 21 and capable of being sealingly connected to the suck back tube 21. The proximal end of the second non-return mechanism 23 is detachably and hermetically connected with the suck-back power device 22, and the distal end of the second non-return mechanism 23 is detachably and hermetically connected with the proximal end of the suck-back pipe 21. The first check mechanism 33 and the second check mechanism 23 are both of a manual switching type valve structure including, but not limited to, a rotary type slide valve structure, a planar reciprocating type slide valve structure, and a plunger reciprocating type slide valve structure. As shown in fig. 6a to 6c, the second non-return mechanism is a rotary type spool valve structure 231.

In this embodiment, the proximal end of the injection tube 31, the proximal end and the distal end of the first check mechanism 33, and the distal end of the feeding device 323 are respectively provided with a connector 35, the proximal end of the first check mechanism 33 is detachably and hermetically connected with the feeding device 323, and the distal end of the first check mechanism 33 is detachably and hermetically connected with the proximal end of the injection tube 31; interfaces 25 are respectively arranged at the proximal end of the suck back pipe 21, the proximal end and the distal end of the second backstop mechanism 23, and the distal end of the suck back power device 22, the interfaces 25 and the interfaces 35 are detachable connection structures, the detachable connection structures include a snap structure or a plug fit structure or a thread structure, as shown in fig. 5, a snap structure 253 is arranged at the proximal end of the suck back pipe 21 and the distal end of the extension pipe; a plug-in matching structure 352 is arranged at the proximal end of the injection tube 31 and the distal end of the feeding device 323; as shown in fig. 6a, a screw structure 251 is provided at the proximal end of the suction pipe 21 and the distal end of the second anti-backup mechanism 23, when the interface 25 is in the connection state, the suction pipe 21 is tightly connected with the extension pipe, so as to ensure that the liquid does not seep out at the interface 25; a screw thread structure 351 is provided at the proximal end of the injection tube 31, the proximal and distal ends of the first backstop mechanism 33, and the distal end of the feeding block 323 to realize a detachable sealing connection.

As shown in fig. 6a, the suck-back power device 22 includes a suck-back extension tube 24 detachably and hermetically connected to the proximal end of the second non-return mechanism 23, a suck-back piston 220 located in the suck-back extension tube 24, and a rod or tube serving as the suck-back power device, the suck-back piston 220 is in sliding and sealing fit with the suck-back extension tube 24, and the proximal end of the suck-back piston 220 is always in contact with and connected to the rod or tube, the liquid is pre-loaded in the suck-back tube 21 and the suck-back extension tube 24, the liquid fills the space between the distal end of the suck-back tube 21 and the suck-back piston 220, so that the liquid, the suck-back piston 220 and the rod or tube are combined into the transmission medium 221, and the power source 223 directly provided by an operator directly acts on the proximal end of the rod or tube, driving the rod or tube, 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 operator monitors and judges the effectiveness of the needle insertion during the needle insertion, as shown in fig. 6a and 6b, the operator manually operates the first non-return mechanism 33 to close the valve, and simultaneously operates the second non-return mechanism 23 to open the valve, and then judges the effectiveness of the needle insertion. If a certain pulling force is applied to the rod body or the tube body, the rod body or the tube body moves towards the near end in the suck-back extension tube 24, if no resistance exists, the rod body or the tube body can move towards the near end easily, and an operator can judge that the needle point is not positioned in target tissue, so that the method is helpful for the operator to judge the correctness of the position of the needle insertion quickly and accurately. The distal end of the shaft or tube and the suck-back piston 220 can obtain this pulling force very timely, so that the liquid in the system is sucked by the negative pressure, so that the liquid moves integrally in the proximal direction, and the filler 5 loaded in the syringe 31 keeps relatively still continuously, thereby ensuring the correctness of the operator making a judgment that the needle tip 11 is not located in the target tissue 9 quickly.

After making a determination of the effectiveness of the insertion and ensuring that the insertion is effective, the operator may keep the needle tip 11 at the insertion position, i.e. the insertion depth within the ventricular wall 91, and then perform an injection at a targeted site "in situ", the steps comprising at least: the first non-return mechanism 33 is manually operated to open the valve thereof, and the second non-return mechanism 23 is manually operated to close the valve thereof; then, referring to the third embodiment, the feeding device 323 is used to inject single or multiple target sites, so as to ensure that the injection process of each target site is performed smoothly, and finally, the safety and effectiveness of the operator using the system to perform single or multiple injections are met.

Finally, it should be understood that the above-mentioned embodiments are merely preferred embodiments of the present application, and are not intended to limit the present application, and any modifications, equivalents, improvements, etc. made within the spirit and principle of the present application should be included in the protection scope of the present application.

Claims

1. An injection system capable of monitoring the effectiveness of a needle insertion, comprising: the injection system comprises an injection needle (1), a suck-back assembly (2), an injection assembly (3) and an injection (5), wherein the injection needle (1) is arranged at the far end of the injection system, the suck-back assembly (2) comprises a suck-back pipe (21) and a suck-back power device (22), the inner cavity of the injection needle (1) is communicated with the inner cavity of the suck-back pipe (21) in a fluid mode, the injection assembly (3) comprises an injection tube (31) and an injection control device (32), the inner cavity of the injection needle (1) is communicated with the inner cavity of the injection tube (31) in a fluid mode, the injection (5) is loaded in the injection tube (31), and the penetrating position of the injection needle (1) is judged through the movement resistance of the suck-back power device (22) in the suck-back pipe (21) in the operation process.

2. Injection system according to claim 1, wherein the proximal end of the injection needle (1) is sealingly connected to the return tube (21) or to the distal end of the injection tube (31), and wherein a communication port (20) is provided at the distal end areas of the injection tube (31) and the return tube (21), said communication port (20) bringing the lumen of the injection tube (31) and the lumen of the return tube (21) into fluid communication.

3. An injection system according to claim 1, wherein a connection chamber (4) is provided at the distal end of the aspiration tube (21) and the injection tube (31), the connection chamber (4) being sealingly connected to the injection needle (1) such that the lumen of the injection needle (1) is in fluid communication with the lumen of the aspiration tube (21) and the lumen of the injection tube (31), respectively.

4. An injection system according to claim 2 or 3, wherein a separation membrane (6) is provided at the communication port (20) or at the connection chamber (4).

5. Injection system according to claim 1, wherein the injection assembly (3) further comprises a first backstop mechanism (33) provided within the injection tube (31) and/or on the proximal end of the injection tube (31), and the aspiration assembly (2) further comprises a second backstop mechanism (23) provided on the proximal end of the aspiration tube (21).

6. An injection system according to claim 1, wherein the retraction power means (22) comprises a power source (223) and a transmission medium (221), the power source (223) being arranged outside the proximal end of the retraction tube (21), the transmission medium (221) being at least partially located in the lumen of the retraction tube (21), the transmission medium (221) being movable along the lumen of the retraction tube (21).

7. An injection system according to claim 6, wherein the aspiration power means (22) further comprises an aspiration piston (220), the aspiration piston (220) being in sliding sealing engagement with the aspiration tube (21) and a proximal end face of the aspiration piston (220) being in constant contact with the transmission medium (221), the power source (222) being capable of driving the transmission medium (221) and the aspiration piston (220) to move within the inner cavity of the aspiration tube (21).

8. An injection system which can monitor the effectiveness of a needle insertion according to claim 1, characterized in that it further comprises a monitoring mechanism (7).

9. An injection system according to claim 1, wherein the monitoring means (7) is a monitoring chip (71) arranged in a distal part of the injection system, or the monitoring means (7) is a monitoring marker (72) arranged on the injection needle (1), or the monitoring means (7) is a viewing member (73) made of a material having light-transmitting properties.

10. An injection system capable of monitoring the effectiveness of a needle insertion according to claim 1, characterized in that the injection control device (32) comprises a feeding device (323), the feeding device (323) contains the injectate (5), and the distal end of the feeding device (323) is communicated with the injection tube (31).