CN114159646A

CN114159646A - Myocardial filling system

Info

Publication number: CN114159646A
Application number: CN202010956485.7A
Authority: CN
Inventors: 李彪; 陈琦; 陈超; 吕世文
Original assignee: Ningbo Diochange Medical Technology Co Ltd
Current assignee: Ningbo Diochange Medical Technology Co Ltd
Priority date: 2020-09-11
Filing date: 2020-09-11
Publication date: 2022-03-11
Also published as: WO2022052797A1

Abstract

The invention relates to a myocardial filling system, which comprises a stabilizing device, an injection device, a guide device and filler, wherein the injection device comprises an injection assembly, an outer tube assembly and a needle outlet handle, an injection needle, an injection tube and an injection interface of the injection assembly are communicated with each other by fluid, so that filler enters from the injection interface and is ejected from the injection needle, an injection needle guide hole and an adsorption hole are arranged in the guide device, the injection needle handle is operated to ensure that the injection needle extends out of the injection needle guide hole to realize the function of pricking the target tissue, the stabilizing device also comprises a negative pressure suction device, the negative pressure suction device comprises a suction power source and a suction cavity, the suction power source is positioned outside the myocardial filling system, the adsorption hole and the suction source form gas communication through the suction cavity to realize negative pressure suction, the stabilizing device is provided with a self-adaptive device, so that the stabilizing device is deformed adaptively, and negative pressure is formed between the stabilizing device and the target tissue conveniently. The invention has the advantages of convenient and fast target needle insertion, controllable injection depth, safe and reliable injection and excellent filling effect.

Description

Myocardial filling system

Technical Field

The invention relates to the field of medical equipment, in particular to a myocardial injection filling system.

Background

In the medical field of minimally invasive surgery, such as tissue injection filling, it is critical to use a suitable injection device or filling system to inject a specific amount or volume of injectate (including filler) into a target area or specific location (including injection depth) of the tissue to be treated or repaired. The tissues suitable for injection filling are mainly divided into two types, the first type is facial or external tissues such as cheek, forehead, nose, chest, buttocks and the like which are mostly used for decoration or beauty, the second type is internal tissues or organs such as heart myocardial wall, blood vessel wall and the like which are recently developed and are used for disease treatment or repair, the tissues have certain elasticity but mostly are dense structures, and generally, suitable injection has the characteristics of certain fluidity but high viscosity, if the conventional injector is used for injecting the injection, including commercialized hyaluronic acid gel and seaweed hydrogel which has clinical application value, the method can cause that: 1) because the viscosity of the injection is high, a thick (such as OD is more than or equal to 0.5mm) injection needle needs to be selected, so that the injection is pushed out from the injection tube through the injection needle in a relatively loose manner, however, when the injection with the thick injection needle is inserted into a tissue, the wound is large, a needle hole left in the tissue after the needle is removed is not easy to heal, obviously, the development trend of minimally invasive surgery is not met, the left large needle hole easily causes the leakage of the injection, the effectiveness of the surgery is influenced, the wound infection or the tissue adhesion and other safety problems of the tissue or the organ which may contact with the wound infection are easily caused, and the thin injection needle has a plurality of disadvantages, including: firstly, when the injection needle is withdrawn or inserted into a target tissue, high risk of needle bending or even needle breakage is easy to occur; the inner cavity of the injection needle for injecting the injection substance to flow out is too small, so that the injection substance is difficult to be pushed from the injection tube, and the traditional injector adopts a simple design of pushing a piston and a piston rod and is difficult to meet the harsh requirement; to achieve the effectiveness of the injection and filling operation, the amount of the injected substance needs to reach a certain value, usually several ml to several hundreds ml, and for this, not only multiple point selection and positioning on the surface of the target tissue are required, but also a specific amount of controllable injection needs to be performed on each target point, and particularly, for the myocardial injection and filling operation, up to 20 times of point selection and target positioning are required, and the operation channel preferentially adopted by the operation comprises: the minimally invasive approach is a minimally invasive approach which reaches the outer surface (epicardium) of the heart through a small chest incision under an endoscope, and an interventional approach which reaches the inner surface (endocardium of a left ventricle cavity) of the heart along an arterial system through a femoral artery access, however, the heart is a complex three-dimensional structure, the inner surface and the outer surface of the heart are all bent and uneven, and the minimally invasive operation channel has relative limitations, so that multiple point selection and accurate target positioning are very challenging, the traditional injector cannot be used for realizing the multiple point selection and the accurate target positioning, in addition, the injection for up to 20 times requires an operator to conveniently and quickly supplement and load an injection into an injection tube, and the traditional injector sucks the injection into the injection tube from the injection tube by pulling back a piston, and is time-consuming and labor-consuming; 2) the high viscosity of the injection inevitably leads to poor diffusion, when the target area is muscle tissue, the injection difficulty is greatly increased, meanwhile, in the injection process, the self-tension of the tissue forces the injection to be extruded out of the tissue along the outer wall of the injection needle in the reverse direction, so that a large amount of leakage of the injection is caused, and the controllable injection of the injection amount cannot be ensured; 3) when the myocardial injection filling operation is carried out, a target area is the myocardial wall of the heart, the heart is a continuously beating organ, except for the self-tension of myocardial tissues, the beating of the heart can continuously press an injection object injected from an injection needle, so that the risk of leakage caused by the fact that the injection object is extruded to the surface of the heart in the injection process is greatly increased, certainly, along with the continuous beating of the heart, in the process of injecting the injection object into the myocardial tissues, the position of a needle point of the injection needle in the myocardial tissues is very easy to change, the injection depth of the injection object cannot be accurately and effectively controlled, the effectiveness of the injection filling operation is further influenced, the injection needle can directly penetrate through the whole heart wall, the injection object is accidentally injected into natural cavities such as heart atria chamber/ventricle of the heart and the like, and finally, the injection object flows into and blocks small vessels of a human brain to cause ischemic stroke or blocks the vessels to cause ischemic necrosis In addition, the heart continuously beats and the beating amplitude is large, so that the injection needle is extremely easy to be completely separated from the myocardial tissue, the smooth operation of the operation is further influenced, the operation is prolonged, and the risk is brought to the life safety of target people or patients.

Those skilled in the art have tried to improve upon conventional syringes for different technical purposes, for example a single use syringe disclosed in patent CN200780034572 having a needle that is retracted into the plunger after use and when the needle is retracted the syringe is sealed against leakage from the syringe of any liquid that is still present in the needle or needle. The pierceable seal it provides at the front of the plunger is self-sealing to prevent any leakage of liquid from the front of the syringe, and the distal end of the plunger seals against the rear of the barrel of the syringe to prevent leakage from the rear. The technical purpose of the design is as follows: firstly, medical personnel are prevented from being stabbed when dangerous goods are injected; second, preventing hazardous material from escaping the syringe after the needle is retracted. However, the above technical solutions have the following disadvantages: firstly, the front end area of the injector body provided by the technical scheme is hollow, and leakage objects can enter the area to cause secondary pollution because the leakage of the injection objects in tissues cannot be prevented; secondly, the sealing element is arranged in the injector main body, a dead angle is formed between the sealing element and the needle head retaining element, when the viscosity of the injection material is high, the sealing element can bear high resistance when being pushed by the plunger, and the volume of a dead zone is increased; thirdly, the injector is not suitable for minimally invasive surgery or interventional surgery, cannot adapt to a human body curved channel on one hand, and cannot inject for multiple times on the other hand, if injection is needed for multiple times, the injector needs to be replaced for multiple times to enter and exit the human body, which can cause damage to the human body channel; fourthly, the injector can not accurately judge the actual position of the injection needle, and the pushing distance can only be controlled by an operator in the pushing process; fifth, the syringe has no depth limiting structure, and the injection needle is a straight needle, which may cause uncertain depth of the needle insertion and increase risks; sixth, the syringe is only suitable for single use and cannot perform continuous injections.

Therefore, the prior art has the problems of leakage of injectate, incapability of accurately controlling the injection amount and the injection depth, insufficient operation space and the like.

Disclosure of Invention

In order to overcome the above defects in the prior art, the present invention aims to provide a myocardial filling system for assisting injection of an injection with high viscosity in different spaces, so as to solve the problems of leakage of the injection, uncontrollable injection amount and injection depth, inaccurate needle insertion depth, insufficient operation space, etc. in the prior art.

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

a myocardial filling system comprising a stabilization device, an injection device, a guide device and a filler; wherein

The stabilizing device at least comprises a self-adapting device which is fixedly arranged at the far end of the myocardial filling system, the self-adapting device is provided with a form self-adapting structure, and when the self-adapting device is attached to the surface of myocardial tissue, the relative position of the myocardial filling system on the myocardial tissue is limited;

the injection device at least comprises an injection assembly, the injection assembly comprises an injection needle, an injection tube and an injection control device, and the filler realizes controllable injection to the myocardial tissue through the injection assembly;

the guiding device is fixedly arranged at the far-end area of the myocardial filling system and is positioned in the self-adaptive device, and an injection needle guiding hole which forms a sliding fit with the injection needle is arranged on the guiding device, so that the positioning and the needle outlet functions of the injection needle on myocardial tissues are realized.

Preferably, the stabilizing device comprises a negative pressure suction device, the negative pressure suction device comprises a suction power source and a suction cavity, the suction power source is located outside the myocardial filling system, the guide device is provided with an adsorption hole, and the self-adaptive device is in gas communication with the adsorption hole, the suction cavity and the suction power source to realize a negative pressure suction function.

Preferably, the injection device includes the injection control mechanism, the injection control mechanism includes outer tube subassembly and play needle handle, the outer tube subassembly includes outer tube, outer tube handle and accuse curved mechanism, the outer tube handle is fixed to be set up the near-end of outer tube, the injection subassembly runs through the outer tube subassembly, it sets up to go out the needle handle on the syringe.

Preferably, the injection needle has two forms, namely a first form with a straight line shape when the needle point of the injection needle is positioned in the injection needle guide hole, and a second form with a curved arc shape after the injection needle extends out of the injection needle guide hole; the needle guide aperture on the guide ensures that the second form of the injection needle remains relatively stationary with respect to the myocardial filling system.

Preferably, the self-adaptive device of the stabilizing device is a corrugated structure, and the corrugated structure comprises one or more of annular texture, arc texture and strip texture; wherein the annular texture and/or the arcuate texture are distributed annularly on the stabilizer along a circumferential direction of the stabilizer such that the stabilizer is resilient to compression in an axial direction; the strip-shaped textures are distributed at the distal end region of the stabilizing device along a distally inclined direction, so that the distal end portion of the stabilizing device has a radially expandable and expandable resilience; or the adaptive means are directly made of a resilient material.

Preferably, the distal region of the injection tube is provided with an adaptive bend structure, and the bend-controlling mechanism comprises a distal fixing piece, a bendable section, a bend-controlling piece and a bend-controlling handle; wherein the bendable section is located at a distal end region of the outer tube, the bendable section axially covering the adaptively bent structure partially or entirely; the far end of the bending control piece is fixedly connected with the outer tube through the far end fixing piece; the bending control handle comprises a bending control operation part, a bending control part and a bending control seat, and the near end of the bending control part is fixedly connected with the bending control part; operating the bending control operation part, wherein the bending control part drives the bending control part to move axially to realize the bending of the distal part of the myocardial filling system; the bending control piece is a bending control wire which is axially laid in the outer pipe wall or outside the outer pipe, or the bending control piece is a bending control pipe which is sleeved in the outer pipe.

Preferably, the bending control piece is a bending control pipe sleeved in the outer pipe, the outer pipe and the bending control pipe are in coaxial sliding fit, the bendable section of the outer pipe is a plurality of hollow structures A, the hollow structures A are narrow strip-shaped through grooves, and the hollow structures A are parallel to each other and surround the outer pipe; in the bendable section of outer tube, accuse return bend is provided with a plurality of hollow out construction B, hollow out construction B is the logical groove of narrow strip shape, and a plurality of hollow out construction B are parallel to each other to encircle on the accuse return bend, a plurality of hollow out construction A and a plurality of hollow out construction B partially or whole coincidence in the axial direction, but the both sides of the branch at the pipe wall.

Preferably, an outer tube sealing member which is synchronously bent with the bendable section is hermetically coated outside the bendable section area of the outer tube; a control elbow sealing piece is fixedly connected in the outer pipe handle, the control elbow penetrates through the control elbow sealing piece, and the control elbow form sliding sealing fit; an injection tube sealing piece is arranged on the bending control piece, the injection tube penetrates through the injection tube sealing piece, and the injection tube form sliding sealing fit; the outer tube sealing piece, the control elbow sealing piece and the injection tube sealing piece, with the injection tube with the cubical space that the outer tube encloses forms the suction chamber, the absorption hole the suction chamber with the outer tube handle through-hole that sets up in the outer tube handle forms the suction passageway.

Preferably, a control elbow through hole is provided on the control elbow between the distal end of the control elbow seal and the proximal end of the outer tube, and the suction channel includes the control elbow through hole, so that the outer tube handle through hole and the adsorption hole are in gas communication through the control elbow through hole.

Preferably, the outer surface of the injection tube is fixedly provided with a local convex structure which is integrally designed with the injection tube, and the convex structures are distributed in a point shape or a strip shape, so that the injection tube and the outer tube form a coaxial sliding fit.

Preferably, the needle outlet handle comprises a needle outlet base, a needle outlet stroke control mechanism and/or a needle outlet limit control mechanism; the needle outlet base is axially limited or fixedly connected with the outer tube handle or the bending control mechanism; the needle outlet stroke control mechanism realizes the stroke control of the injection needle extending out of the guide device; the needle-out limit control mechanism limits the maximum travel of the injection needle extending out of the implementation guide device.

Furthermore, the needle-out stroke control mechanism comprises a stroke control piece and a stroke control operation part, wherein the stroke control piece is in limit connection or fixed connection with the injection tube, and the stroke control operation part is operated to ensure that the injection needle extends out in a stepping or continuous mode relative to the guide device so as to realize the stroke control of the injection needle extending out of the guide device; the needle-out limiting control mechanism comprises a limiting control piece and a limiting control operation part, the limiting control piece axially slides relative to the needle-out seat, so that the limiting control piece can abut against the stroke control piece, and the needle-out limiting control mechanism limits the maximum stroke of the injection needle extending out of the guide device.

Preferably, be provided with accuse bent angle sign on the accuse curved mechanism, perhaps be provided with the scale mark of going out of the needle that the operator of being convenient for observed on the handle of going out the needle, it includes scale mark, stroke pointer and/or spacing pointer to go out the needle scale mark, the scale mark is located a needle file, the stroke pointer is fixed to be set up on the stroke control piece, spacing pointer is fixed to be set up on the spacing control piece.

Preferably, the distal end of the guiding device is fixedly provided with a filter structure, and the filter structure is provided with one or more micropores, so that gas can pass through the micropores and liquid cannot pass through the micropores.

Preferably, the distal region of the myocardial filling system is provided with a monitoring mechanism, the monitoring mechanism is a visual window penetrating through the tube walls of the outer tube and the control bend, or the monitoring mechanism is an observation component made of a material with light transmittance, and the observation component is part or all of the injection tube, the outer tube, the control bend, the outer tube sealing member and/or the adaptive device, and has an effect of assisting in observing the position of the puncture needle.

Compared with the prior art, the invention has the following beneficial effects:

1. when the negative pressure adsorption device provided by the invention injects the filler, especially the filler with high viscosity, into the non-cavity area of the human tissue, such as muscles, or the moving human tissue, such as cardiac muscle, etc., the stabilizing device and the target tissue form a negative pressure state through the negative pressure suction device, so that the phenomenon that the filler is reversely extruded out of the injection area, namely the filler reversely leaks from the human tissue in the area, which is caused by poor diffusivity of the filler in the tissue or self-tension or moving force of the tissue, is fundamentally prevented in the injection process, the injection amount entering the target tissue is accurately controlled, and the tissue filling degree is finally maximized, therefore, the injection is safe, reliable and controllable, and the filling effect is good.

2. The stabilizing device provided by the invention is provided with the self-adaptive device, so that the stabilizing device is subjected to adaptive deformation after being attached to the surface of the target tissue, the situation that the needle insertion is difficult or the needle insertion cannot be performed due to different needle insertion points of the surface form of the target tissue or different inclination angles of the myocardial filling system relative to the target tissue is completely avoided, the targeted needle insertion and the subsequent injection filling operation are ensured to be smooth, meanwhile, the self-adaptive device is subjected to continuous adaptive change along with the continuous beating of the heart after the needle insertion, the stabilizing device is convenient to continuously keep a negative pressure state with the target tissue, and the negative pressure suction device continuously and effectively exerts the set efficacy.

3. The injection needle provided by the invention has the first form and the second form, and is matched with the guide device, so that the injection needle can safely and smoothly discharge along the injection needle guide hole of the guide device, the accurate positioning of a target injection point on a target tissue is realized, and the high risk of needle bending or needle breaking is avoided; in addition, after the injection needle extends out of the injection needle guide hole, the injection needle with the second shape is in a bent arc shape, so that the injection needle is kept relatively static with target tissues under the continuous beating of the heart, the accidental needle release in the needle inserting and injection processes is prevented, and the filler leakage event is avoided.

4. The needle-out limiting control mechanism provided by the invention can control the maximum depth of the injection needle inserted into the target tissue according to clinical actual requirements, namely the injection needle is sent to a preset depth by controlling the needle-out limiting control mechanism, the injection depth of the injection needle can be accurately controlled, and the phenomenon that the needle point of the injection needle penetrates through the whole target tissue such as the myocardial wall due to too-deep insertion to cause the filler to be unexpectedly injected out of the target tissue such as the blood of a ventricular cavity or a coronary artery to finally cause a life-threatening medical accident is avoided.

5. The bending adjusting mechanism and the bending angle control mark are suitable for minimally invasive surgery or interventional surgery, are particularly suitable for myocardial injection filling surgery needing multiple point selection, target positioning, accurate and controllable injection depth and injection amount, and realize multi-direction and multi-operation-space injection of a myocardial filling system, so that the design structure is firm, and the operation is safe, fast and controllable.

6. According to the injection device, the detachable connecting structure is arranged between the material supplementing device and the injection assembly, so that multiple timely filling, loading and injection of an injection can be met in the injection process.

7. The technical scheme provided by the invention, particularly the stabilizing device and the self-adaptive device, can realize the successful injection of the injection with high viscosity on the basis of not increasing the diameter of the injection needle, has the advantage of low or almost no leakage of human tissues, is suitable for minimally invasive surgery or interventional surgery, particularly the minimally invasive surgery of injecting and filling the cardiac muscle reaching the outer surface of the heart under the endoscope through the small incision of the chest, does not influence the opening size of the surgery, and reduces the surgery risk.

Drawings

FIG. 1 is a schematic diagram of the overall structure of a central muscle filling system according to an embodiment of the present invention;

FIG. 2 is an overall view of the handle according to the first embodiment of the present invention;

FIG. 3 is a cross-sectional view of a handle along the axial center of a suction channel in accordance with an embodiment of the present invention;

FIG. 4 is a schematic cross-sectional view of a needle outlet handle according to an embodiment of the present invention;

FIG. 5 is a schematic cross-sectional view of an outer tube assembly according to one embodiment of the present invention;

FIG. 6a is a schematic view of an embodiment of a bendable section of an outer tube according to the present invention;

FIG. 6b is a schematic diagram illustrating an embodiment of a bendable section of a bend control member according to the present invention;

FIG. 6c is a schematic cross-sectional view illustrating the relationship between the middle and outer tubes and the bending control members according to an embodiment of the present invention;

FIGS. 7a-7b are schematic views showing the curvature of a central muscle filling system according to an embodiment of the present invention;

FIG. 8 is a cross-sectional view of a seal within an outer tube assembly according to one embodiment of the present invention.

FIG. 9 is a schematic cross-sectional view of a syringe according to one embodiment of the present invention;

fig. 10 is a schematic structural diagram of a suction channel according to an embodiment of the present invention.

FIG. 11 is a front view of a guide device according to an embodiment of the present invention;

FIG. 12 is a rear view of a guide device according to an embodiment of the present invention;

FIG. 13 is a schematic view of a scale mark according to an embodiment of the present invention;

FIG. 14 is a schematic cross-sectional view of a reinforced area of a syringe according to one embodiment of the present invention;

FIG. 15 is a cross-sectional view of a circular groove C in the middle region of a reinforced pipe according to an embodiment of the present invention.

FIG. 16 is a schematic view of a groove D formed in the proximal region of the stiffening tube according to an embodiment of the present invention.

Fig. 17a to 17c are schematic views illustrating the injection needle in the second embodiment of the present invention in a needle-out state.

FIG. 18 is a cross-sectional view of a guide device along the axial center of a needle guide hole according to a second embodiment of the present invention.

Fig. 19 is a schematic diagram of a specific implementation manner of the creasing structure in the third embodiment of the present invention.

Fig. 20 is a schematic diagram of a specific implementation manner of the creasing structure in the third embodiment of the present invention.

Fig. 21a-21b are schematic diagrams illustrating a third embodiment of the wrinkle structure according to the present invention.

Fig. 22 is a schematic diagram of a specific implementation manner of the adsorption enhancement structure in the third embodiment of the present invention.

Fig. 23 is a schematic view of a wall thickness gradient structure in the third embodiment of the present invention.

Fig. 24 is a schematic diagram of a filter structure according to a fourth embodiment of the present invention.

Fig. 25 is a schematic diagram of a specific implementation manner of the monitoring mechanism in the fifth embodiment of the present invention.

Fig. 26 is a schematic diagram of an embodiment of an injection control device according to a sixth embodiment of the present invention.

FIG. 27 is a schematic view of a seventh embodiment of a dual chamber syringe according to an embodiment of the present invention.

FIG. 28 is a schematic sectional view of a reinforced area of a seventh embodiment of a dual chamber syringe according to the present invention.

FIG. 29 is a cross-sectional view of a circular groove C at the middle end region of a reinforced pipe according to a seventh embodiment of the present invention.

FIG. 30 is a schematic view of a groove D formed in the proximal region of the stiffening tube according to a seventh embodiment of the present invention.

Fig. 31 is a schematic diagram illustrating an embodiment of an outer tube assembly according to an eighth embodiment of the present invention.

Fig. 32 is a schematic diagram of an embodiment of the suction channel in the eighth embodiment of the present invention.

FIG. 33 is a schematic view of an embodiment of a needle handle according to the ninth embodiment of the present invention.

The symbols in the drawings indicate the description:

1-stabilizing means, 11-adaptive means, 111-enhanced adsorption means, 112-gradual change means, 12-negative pressure suction means, 121-suction power source, 122-suction chamber, 2-injection means, 21-injection assembly, 211-injection needle, 212-injection tube, 2121-withdrawal judgment tube, 2122-injection filling tube, 2123-fixation tube, 2124-feeding chamber, 2125-injection chamber, 2126-communication port, 213-injection port, 214-injection tube seal, 215-reinforcement tube, 2151-circular groove C, 2152-groove D, 216-flexible tube, 217-injection control means, 2171-injection piston, 2172-piston pusher, 2173-feeding means, 2174-force application grip, 22-injection control means, 221-outer tube assembly, 2211-outer tube, 2212-outer tube handle, 22121-outer tube handle through hole, 22122-interface, 2213-bending control mechanism, 22131-distal end fixture, 22132-bendable segment, 22133-bending control member, 221331-bending control tube through hole, 22134-bending control handle, 221341-bending control seat, 221342-bending control operation part, 221343-bending control part, 22135-bending control tube sealing part, 2214-outer tube sealing part, 222-needle outlet handle, 2221-needle outlet seat, 2222-needle outlet travel control mechanism, 22221-travel control part, 22222-travel control operation part, 22223-travel pointer, 22224-push button, 22225-travel controller, 22226-travel controller fixture, 22227-travel guide, 2223-needle outlet limit control mechanism, 22231-limit control member, 22232-limit control operation part, 22233-limit pointer, 2224-holding part, 22241-groove, 22242-through hole, 23-filtering structure, 24-monitoring mechanism, 241-visible window, 242 is observation part, 3-guiding device, 31-injection needle guiding hole, 32-adsorption hole and 4-filler.

Detailed Description

The invention provides a myocardial filling system, which comprises a stabilizing device 1, an injection device 2, a guide device 3 and a filler 4; wherein

The stabilizing device 1 at least comprises a self-adaptive device which is fixedly arranged at the far end of the myocardial filling system, the self-adaptive device is provided with a form self-adaptive structure, and when the self-adaptive device is attached to the surface of myocardial tissue, the relative position of the myocardial filling system on the myocardial tissue is limited;

the injection device 2 at least comprises an injection assembly 21 and an injection control mechanism 22, the injection assembly 21 comprises an injection needle 211 and an injection tube 212, and the filler 4 realizes controllable injection to the myocardial tissue through the injection assembly 21;

the guiding device 3 is fixedly arranged at the far end region of the myocardial filling system and is positioned in the self-adaptive device, and an injection needle guiding hole 31 which forms a sliding fit with the injection needle 211 is arranged on the guiding device, so that the functions of positioning and needle discharging of the injection needle 211 on myocardial tissues are realized.

The design of the injection needle guide hole has the advantages that the needle outlet position of the injection needle can be limited, the accurate positioning of an injection point on a target tissue is realized, the high risk of needle bending or needle breakage is avoided, the easy and quick performance of the needle inserting performance that the injection needle penetrates into the target tissue is realized by means of a subsequently mentioned needle outlet stroke control mechanism, and the performance characteristics that the target needle inserting is convenient and fast, the injection needle is convenient to withdraw, and the whole process is safe and reliable are achieved.

In one embodiment, the stabilizing device 1 comprises a negative pressure suction device 12, the negative pressure suction device 12 comprises a suction power source 121 and a suction cavity 122, the suction power source 121 is located outside the myocardial filling system, the guiding device 3 is provided with an adsorption hole 32, and the adaptive device is in gas communication with the adsorption hole 32, the suction cavity 122 and the suction power source 121 to realize a negative pressure suction function.

The negative pressure suction device has the advantages that the stabilizing device 1 and the target tissue form a negative pressure state in a working state, the phenomenon that the filler 4 is extruded out of an injection area reversely due to poor diffusion degree of the filler in the tissue or self tension or movement force of the target tissue in the injection process, namely the phenomenon that the filler leaks out of the human tissue in the area reversely is fundamentally prevented, the injection amount entering the target tissue is accurately controlled, the tissue filling degree is maximized, and therefore the negative pressure suction device is safe and controllable in injection and good in filling effect.

In one embodiment, the injection control mechanism 22 comprises at least an outer tube assembly 221 and a needle outlet handle 222, the outer tube assembly comprises an outer tube 2211, an outer tube handle 2212 and a bending control mechanism 2213, the outer tube handle 2212 is fixedly arranged at the proximal end of the outer tube 2211, the outer tube handle 2212 is axially connected or fixedly connected with the bending control mechanism 2213 in a limiting manner, the injection assembly 21 penetrates through the outer tube assembly 221, and the needle outlet handle 222 is arranged on the injection tube 211.

In one particular embodiment, the distal region of the syringe 212 is provided with an adaptive bend mechanism, and the bend-controlling mechanism 2213 comprises a distal anchor 22131, a bendable segment 22132, a bend-controlling member 22133, and a bend-controlling handle 22134; wherein, the bendable section 22132 is located at the distal region of the outer tube 2211, and the bendable section 22132 covers the adaptive bending structure partially or completely in the axial direction; the distal end of the bend control member 22133 is fixedly connected to the outer tube 2211 by a distal fixing member 22131; the bending control handle 22134 comprises a bending control operation part 221342, a bending control piece 221343 and a bending control seat 221341, and the proximal end of the bending control piece 22133 is fixedly connected with the bending control piece 221343; the bending control operator 221342 is operated, and the bending control member 221343 drives the bending control member 22133 to move axially, so as to realize the bending of the distal end part of the myocardial filling system.

In a preferred embodiment, bend-controlling members 22133 are wire bends that are axially disposed within the wall of outer tube 2211 or outside of outer tube 2211, or bend-controlling members 22133 are bend-controlling tubes that are disposed within outer tube 2211.

In a preferred embodiment, the bending control element 22133 is a bending control tube sleeved in the outer tube 2211, the outer tube 2211 and the bending control tube are coaxially and slidably fitted, the bendable section 22132 of the outer tube 2211 is a plurality of hollow structures a, the hollow structures a are narrow strip-shaped through grooves, and the plurality of hollow structures a are parallel to each other and surround the outer tube 2211; in the bendable section 22132 of the outer tube 2211, the control bending tube is provided with a plurality of hollow structures B, the hollow structures B are through grooves in a narrow strip shape, the hollow structures B are parallel to each other and surround the control bending tube, and the hollow structures a and the hollow structures B partially or completely coincide in the axial direction but are respectively located on two sides of the tube wall.

When the bending control operation part 221342 is operated to drive the bending control member 221343 to axially move towards the distal end, the bending control member 22133 simultaneously axially moves towards the distal end, the hollow structure B at the distal end area of the bending control member 22133 gradually opens to bend the bending control member 22133 to a certain angle towards a direction, simultaneously, the hollow structure a at the distal end area of the outer tube 2211 gradually closes to bend the outer tube 211 to the same angle towards the direction, and the bending direction of the distal end part of the myocardial filling system is shown in fig. 7 a; when the bending control operation part 221342 is operated to drive the bending control member 221343 to move axially towards the proximal end, the bending control member 22133 simultaneously moves axially towards the proximal end, the hollow structure B at the distal end area of the bending control member 22133 is gradually closed to bend the bending control member 22133 to a certain angle towards another direction, simultaneously, the hollow structure a at the distal end area of the outer tube 2211 is gradually opened to bend the outer tube 211 to the same angle towards the direction, and the bending direction of the distal end part of the myocardial filling system is shown in fig. 7B.

The bending control mechanism 2213 has the advantages that the bending control mechanism can accurately control the angle change of the region of the bendable section 22132, the angle of the bendable section 22132 can be adjusted according to actual requirements, the bending control mechanism is suitable for minimally invasive surgery or interventional surgery, and is particularly suitable for myocardial injection filling surgery which needs point selection and targeted positioning for 20 times and requires accurate controllable injection depth and injection amount.

In a specific embodiment, outside the bendable section 22132 region of the outer tube 2211, an outer tube seal 2214 is hermetically wrapped for synchronous bending with the bendable section 22132, the distal region of the outer tube seal 2214 is tightly connected to the adaptive device 11, the proximal region thereof is tightly connected to the distal portion of the outer tube handle 2212, a pilot tube seal 22135 is fixedly connected inside the outer tube handle 2212, and the pilot tube 22133 passes through the pilot tube seal 22135 and forms a sliding sealing fit with the two; a syringe seal 214 is provided on bend control member 221343 and syringe 212 passes through syringe seal 214 with a sliding sealing engagement.

The arrangement of the outer tube sealing element 2214, the elbow control sealing element 22135 and the injection tube sealing element 214 effectively enhances the sealing performance of the system, improves the adsorptivity of the stabilizing device on target tissues, prevents the falling-off of the system in the injection process from causing safety accidents, and can also prevent the unsmooth sliding caused by too tight matching.

Further, the three-dimensional space enclosed by the outer tube seal 2214, the control elbow seal 22135, the injection tube seal 214, the injection tube 212 and the outer tube 2211 forms the suction cavity 122, and the suction hole 32, the suction cavity 122 and the outer tube handle through hole 22121 arranged in the outer tube handle 2212 form a suction passage.

It is further preferred that a control elbow through hole 221331 is provided in control elbow 22133 between the distal end of control elbow seal 22135 and the proximal end of outer tube 2211, and that the suction pathway includes control elbow through hole 221331, such that outer tube handle through hole 22121 is in gaseous communication with suction hole 32 via control elbow through hole 221331.

In a preferred embodiment, the outer tube handle 2212 is provided with an interface 22122, and the interface 22122 enables the suction power source 121 to be removably connected to the outer tube handle 2212.

In a preferred embodiment, the suction hole 32 in the guide 3 occupies the remaining area excluding the area occupied by the needle guide hole 31, about two thirds of the cross-sectional area of the inner cavity of the guide 3, and has a length of 50 to 1500mm in the axial direction of the suction chamber 122, and the space of the cross-sectional area of the suction chamber 122 is 0.1 to 20mm²The area of the through hole 221331 of the bend control pipe is 3-30 mm²After a plurality of in vitro tests and animal experiment repeatability verification, the stabilizing device can be ensured not to loosen from the surface of the target tissue when being subjected to a large pulling force (such as 15N).

In one embodiment, as shown in fig. 4, the needle outlet handle 222 comprises a needle outlet housing 2221, a needle outlet stroke control mechanism 2222 and/or a needle outlet limit control mechanism 2223, and the needle outlet housing 2221 is axially limited or fixedly connected with the outer tube handle 2212 or the bend control mechanism 2213. The needle-out stroke control mechanism 2222 realizes stroke control of the injection needle 211 extending out of the guide 3, and the needle-out limit control mechanism 2223 defines the maximum stroke of the injection needle 211 extending out of the guide 3.

In the first embodiment, the needle-withdrawing handle 222 includes a needle-withdrawing seat 2221, a needle-withdrawing stroke control mechanism 2222 and a needle-withdrawing limit control mechanism 2223, the needle-withdrawing stroke control mechanism 2222 includes a stroke control member 22221 and a stroke control operation part 22222, the stroke control member 22221 is connected to the syringe 212 in a limit or fixed manner, and the stroke control operation part 22222 is operated to extend the injection needle 211 relative to the guide device 3 in a step or continuous manner, so as to control the stroke of the injection needle 211 extending out of the guide device 3; the needle-out position-limiting control mechanism 2223 includes a position-limiting control member 22231 and a position-limiting control operation part 22232, the position-limiting control member 22231 axially slides relative to the needle-out holder 2221, so that the position-limiting control member 22231 can abut against the stroke-limiting control member 22221, and the needle-out position-limiting control mechanism 2223 limits the maximum stroke of the injection needle 211 extending out of the guide device 3.

In another embodiment, the needle output handle 222 includes a needle output holder 2221, a needle output stroke control mechanism 2222, and a grip portion 2224, wherein the needle output holder 2221 and the outer tube handle 2212 are axially connected or fixedly connected, and the needle output stroke control mechanism 2222 includes a push button 22224, a stroke controller 22225, a stroke controller holder 22226, and a stroke guide 22227. The stroke controller 22225 is fixedly connected with the injection tube 212, a groove 22241 is fixedly arranged at the far end region of the holding part 2224, the depth of the far end region of the groove 22241 is deeper than that of the near end region, the depth of the far end region is equal to the thickness of the stroke guide 22227, but the groove 2224 does not penetrate through the holding part 2224, the stroke guide 22227 is in a ratchet shape and is fixedly arranged in the far end region of the groove 22241, a through hole 22242 penetrating through the holding part is arranged at the near end region of the groove 22241, a push button 22224 is arranged in the groove 22241, the stroke controller 22225 and the push button 22224 are fixedly connected through the stroke controller fixing part 22226, the push button 22224 can slide on the groove 22241 and the stroke guide 22227, and the push button 22224 is operated to ensure that the injection needle 211 is extended in a stepping mode relative to the guide device 3, so that the stroke control of the injection needle 211 extending out of the guide device 3 is realized.

The two stroke control designs have the advantages that the depth of the injection needle can be controlled according to clinical requirements, the needle outlet stroke of the injection needle can be accurately controlled, the injection precision is improved, the needle point of the injection needle caused by too deep penetration is prevented from penetrating through the whole target tissue, the risk in the injection process is reduced, and the two stroke control designs are convenient to operate and safe and reliable in injection.

In a preferred embodiment, the outer tube handle 2212, the bend control handle 22134, and the needle outlet handle 222 form an integral large handle.

In a preferred embodiment, the bend-controlling mechanism 2213 is provided with a bend-controlling angle mark, or the needle-withdrawing handle 222 is provided with a needle-withdrawing scale mark convenient for the operator to observe, as shown in fig. 13, the needle-withdrawing scale mark comprises scale lines 22211, a stroke pointer 22223 and/or a limit pointer 22233, the scale lines 22211 are located on the needle-withdrawing seat 2221, the stroke pointer 22223 is fixedly arranged on the stroke control 22221, the limit pointer 22233 is fixedly arranged on the limit control 22231, the limit pointer 22233, the needle-withdrawing seat 2221 and the stroke pointer 22223 are coaxially arranged from far to near, and the actual needle-withdrawing length of the injection needle 211 is determined by determining the position of the stroke pointer 22223.

The scale mark design has the advantages that the specific positions of the stroke pointer and the limiting pointer can be clearly judged by increasing the mark scale lines on the needle outlet seat, the real-time positions of the injection needles of the system can be directly judged by judging the positions of the pointers, the needle inserting depth of the injection needles is accurately controlled, the needle inserting precision of the injection needles is further improved, and the situation that the needle points of the injection needles penetrate through the whole target tissue like the myocardial wall due to deep insertion is avoided.

In one embodiment, as shown in fig. 17a-17c, the needle 211 has a shape memory, preferably being pre-formed in a shape, such as a curved arc, using a resilient metal tube, thereby providing both the first and second configurations. When the needle point of the injection needle 211 is located in the needle guide hole 31, as shown in fig. 17a, it has the first form, i.e. the straight state, so that the injection needle 211 can be safely and smoothly discharged along the needle guide hole 31; the needle-withdrawing handle 222 is operated to extend the injection needle 211 from the needle guide hole 31, and the injection needle 211 is gradually unfolded in the predetermined shape until it is completely withdrawn, as shown in fig. 17b-17c, and finally forms a second shape, i.e. a curved arc shape, so that the target tissue can be absorbed into the self-adaptive device and touch the distal surface of the guide device 3 no matter the surface of the target tissue is flat, or the surface of the target tissue is curved and uneven, due to the design of the aforementioned negative pressure suction device, on the premise that the injection needle pre-shaped into the curved arc shape can easily perform the needle inserting function to the target tissue. Certainly, in the second form, the cutting edge of the injection needle 211 should face the direction away from the myocardial filling system, and the motion track of the injection needle 211 is arc-shaped, so as to avoid the cutting edge from scraping the inner wall of the injection needle guide hole to influence the smoothness of needle discharge; the injection needle guide hole 31 on the guide device 3 can ensure that the second shape of the injection needle 211 is kept relatively static relative to the myocardial filling system to a certain extent, so that the position of the injection needle including the needle point in the target tissue is kept unchanged continuously in the whole subsequent injection process, and finally, a specific amount or a specific volume of filler is injected to a set position in the target tissue, and the accurate control of the injection depth is realized.

In a preferred embodiment, the inner diameter ID of the injection needle 211 is 0.05-0.4 mm, the wall thickness is 0.01-0.2 mm, when the injection needle 211 is in the second form, the bending radius R is less than or equal to 8mm, the size of the injection needle guide hole 31 in the guide device 3 is matched with the outer diameter of the injection needle 211, and the matching clearance is not more than 0.1 mm.

The design of the first form and the second form of the injection needle also enables the injection needle and the target tissue to keep relatively static, improves the safety of the injection process, reduces the risk that the injection needle accidentally drops in the jumping process of the target tissue, and avoids the leakage of the filler. The cutting edge of the injection needle is towards the direction which is helpful for the filler in the target tissue to be extruded to the direction far away from the myocardial filling system, and the filling effect of the filler is obviously improved.

In a preferred embodiment, as shown in fig. 14, the syringe 212 is adapted to deform, a reinforced tube 215 is fixedly disposed from the proximal region of the syringe 212 to the injection port 213, and a flexible tube 216 is wrapped around the proximal region of the reinforced tube 215. The advantage of the above-described design of the tube 215 and the tube 216 is that the addition of the tube 215 increases the resistance of the syringe 212 to bending in the region of the handle and in the region of the exposed handle, preventing the syringe 212 from deforming in an adaptive manner during the pushing process, so that when the syringe is moved a certain distance in the distal direction, the needle will also move the same distance, thereby ensuring the accurate control of the length and the speed of the needle discharge, further improving the safety of the myocardial injection system, being helpful to strengthen the accurate control strength of the injection depth, and of course, the system can be prevented from being unusable under the unexpected conditions, such as falling, not in place and the like, the addition of flexible tube 216 somewhat reduces the rigidity of stiffening tube 215, preventing the inevitable bending or breaking events of syringe 212 during handling, thus improving system comfort, safety and durability.

Further preferably, a plurality of circular grooves C are formed in the middle end region of the reinforcing tube 215, as shown in fig. 15, the circular grooves C2151 are through holes penetrating through the reinforcing tube 215 and are distributed in the middle section region of the reinforcing tube 215, the injection tube 212 is fixedly connected by injecting glue through the through holes and adopting a connection method such as glue joint, and a plurality of grooves D are formed in the proximal end region of the reinforcing tube 215, as shown in fig. 16, the grooves D2152 are pi-shaped grooves penetrating through the reinforcing tube 215 and are spirally distributed in the proximal end region of the reinforcing tube 215 for improving the folding resistance of the injection tube 212, and the flexible tube 216 completely covers the grooves D.

The design of the stabilizing device 1 and the adaptive device 11, especially the adaptive device 11 has compressible resilience, can realize successful injection of an injection with high viscosity on the basis of not increasing the diameter of an injection needle, has the advantage of low or almost no leakage of human tissues, is suitable for minimally invasive surgery or interventional surgery, especially for minimally invasive surgery of myocardial injection filling reaching the outer surface of the heart under an endoscope through a small chest incision, does not influence the opening size of the surgery, and reduces the surgical risk. In one embodiment, the adaptive device 11 is a corrugated structure, and the corrugated structure includes one or more of the following circular texture, arc texture, and stripe texture:

(1) as shown in fig. 19, the annular texturing is distributed annularly on the stabilizer in the circumferential direction of the stabilizer, so that the stabilizer 1 is resilient in the axial direction to be compressible. The design of the annular texture has the advantages that after the stabilizing device 1 is adsorbed on target tissues, the annular texture is subjected to adaptive deformation and can freely rotate on a circumferential angle, the moving range of the device is improved, for myocardial injection and filling, even though a minimally invasive operation channel has relative limitation, the adaptive texture can be subjected to adaptive strain by virtue of the adaptive device, so that multiple point selection and accurate targeted positioning on the surface of the heart are realized, and further, the design of the negative pressure suction device is combined, the smooth operation of multiple puncture and subsequent filler injection is finally ensured, of course, the annular texture can be continuously subjected to adaptive change along with the jumping of the target tissues, the stabilizing device 1 and the target tissues are always kept in a negative pressure state, and the negative pressure suction device 12 continuously and effectively plays a set effect;

(2) when the corrugated structure is an arc-shaped texture, as shown in fig. 20, the arc-shaped texture is annularly distributed in the proximal end region of the stabilizer 1 along the circumferential direction of the stabilizer 1, so that the stabilizer 1 has compressible resilience in the axial direction. The arc texture design has the advantages that after the stabilizing device 1 is adsorbed on target tissues, adaptive deformation occurs, but the stabilizing device can only move in the direction limited by the arc textures, so that the problem that the acupuncture is difficult or impossible due to the difference of the morphosis of the surface of the target tissues of acupuncture points is avoided to a certain extent, the smooth acupuncture process is ensured, the arc textures can be continuously adaptively changed along with the jumping of the target tissues, the stabilizing device 1 and the target tissues are conveniently kept in a negative pressure state, and the negative pressure suction device 12 can continuously and effectively exert established efficacy;

(3) as shown in fig. 21a-21b, when the corrugated structure is a strip-shaped texture, the strip-shaped texture is distributed in the distal region of the stabilization device 1 along the direction of inclination toward the distal end, so that the distal portion of the stabilization device 1 has a resilient property that can be expanded, when the stabilization device 1 is in a natural unconstrained state, the corrugated structure is in a fully expanded state, the maximum diameter of which can exceed 10mm, when the stabilization device 1 is in a compressed state, the strip-shaped texture can be stacked in a manner that can be reduced to smoothly enter and exit a lumen with a small inner diameter ID, so as to adapt to various access passages of the myocardial filling system to the myocardial surface, particularly including a 5mm or 10mm puncture cannula lumen equipped for endoscopic surgery. The advantage of this design still lies in, and bar texture carries out adaptability along with the target tissue beats and deforms, can increase the area of contact of stabilising arrangement 1 and target tissue, improves the adsorptivity, is convenient for keep being the negative pressure state between stabilising arrangement 1 and the target tissue.

In another embodiment, the adaptive means is made directly of a resilient material, such as silicone.

In a preferred embodiment, as shown in fig. 22, the stabilizing device 1 is provided with the reinforced absorbing structure 111, and the reinforced absorbing structure 111 is convex in the waist region of the stabilizing device 1 and converges towards the distal end, so that the volume enclosed by the stabilizing device 1 is maximized, and the volume of the target tissue absorbed to the inner cavity of the stabilizing device 1 is increased, thereby significantly improving the absorption efficiency, helping to maintain the negative pressure state between the stabilizing device 1 and the target tissue, and avoiding the phenomenon that the distal end edge of the stabilizing device is turned towards the proximal end to generate the raised edge, which affects the absorption effect.

In another preferred embodiment, as shown in fig. 23, the stabilizing device 1 is provided with a gradual change structure 112, the gradual change structure 112 is gradually changed from thick to thin at the waist part of the stabilizing device 1 and towards the distal end region, so that the strength of the stabilizing device 1 is improved, deformation during adsorption is prevented, the adsorption effect is influenced, and even the stabilizing device 1 is collapsed, so that the negative pressure state is failed, and the wall thickness of the proximal end region is preferably designed to be 1-1.5 mm, and the wall thickness of the distal end is preferably designed to be 0.2-0.5 mm.

In one embodiment, the outer surface of the injection tube 212 is fixedly provided with a local protrusion structure, the protrusion structure and the injection tube 212 are designed as a whole, the protrusion structure is distributed in a dot shape or a strip shape, so that the injection tube 212 and the outer tube 2211 form a coaxial sliding fit, and after the protrusion structure is contacted with the outer tube 2211, the injection tube 212 can be prevented from being folded or deformed in the axial sliding process, so that the needle discharging precision of the injection needle 211 is reduced, and therefore the same effect as that of the reinforcing tube 215 is achieved, not only is the contact area between the injection tube 211 and the outer tube 2211 greatly reduced by the protrusion structure, the friction resistance is remarkably reduced, meanwhile, the space of a suction channel is increased, and the adsorption efficiency is greatly improved.

In one embodiment, as shown in fig. 24, a filter structure 23 is fixedly disposed at the distal end of the guiding device 3, and the filter structure 23 has one or more micro-pores, so that gas can pass through the micro-pores and liquid cannot pass through the micro-pores. When the system is in a working state, the stabilizing device 1 can still be adsorbed on the target tissue, and the adsorption force is basically consistent with that before the filter structure 23 is added, the filter structure 23 is designed to have the advantage that if the filler 4 leaks from the target tissue in the injection process, the filler 4 can be blocked on the filter structure 23, the blockage of the suction channel caused by the back suction of the filler 4 into the suction cavity 122 in a negative pressure state is prevented, multiple multi-point injections of the system are facilitated, and the reutilization property of the system is fully ensured; in addition, the filtering structure 23 covers the guiding device 3, so that the contact area is increased, the target tissue is prevented from being damaged when being attached to the guiding device 3, and the safety is improved.

In one embodiment, as shown in fig. 25, the distal region of the myocardial filling system is provided with a monitoring mechanism 24. The monitoring mechanism 24 is a visible window 241 penetrating through the wall of the outer tube 2211 and the controlled bend tube 22133, or the monitoring mechanism 24 is an observation part 242 made of a material with light transmittance, the observation part 242 is part or all of the injection tube 212, the outer tube 2211, the controlled bend tube 22133, the outer tube sealing member 2214 and/or the adaptive device 11, and the design of the monitoring mechanism 24 has the advantages that the depth of the injection needle at the position of the injection needle and the position of the injection tube can be monitored in real time in the injection process, the injection effect and the injection progress of the filler can be better judged, and the safety is improved.

In one embodiment, the injection assembly 21 further comprises an injection control device 217, the injection control device 217 comprises an injection piston 2171, a piston push rod 2172 and a feeding device 2173, the injection piston 2171 is made of a high polymer material with elasticity and shape recovery and is fixedly arranged at the distal end of the piston push rod 2172, and the injection piston 2171 can realize sliding sealing fit with the injection tube 212; the piston push rod 2171 is made of a solid material and a force applying grip 2174 is provided at the proximal end of the piston push rod 2171 to enable force to be transmitted in the axial direction, pushing the piston push rod 2171 to enable axial movement of the injection piston 2171 in the syringe 212.

In one embodiment, a removable connection structure is provided between the feed supplement device 2173 and the injection assembly 21; further, a feed supplement device 2173 is provided at the proximal end of the injection tube 212, being an adjustable device, the feed supplement device 2173 being in an open state when the filler 4 is added to the injection tube 212; when the myocardial filling system is in the operational state for injection, the feeding device 2173 is in the off state. The design is convenient for an operator to conveniently and quickly carry the injection 4 in the injection tube 212 in the myocardial injection filling operation with up to 20 point selection and targeted positioning injections, so that the requirement of carrying out filling and injecting the injection 4 for multiple times in time can be met.

The present invention will be described in detail and specifically with reference to the following examples to facilitate better understanding of the present invention, but the following examples do not limit the scope of the present invention.

Example one

The present embodiment provides a myocardial filling system (hereinafter simply referred to as "the present system") composed of a stabilization device 1, an injection device 2, a guide device 3, and a filler 4. As shown in fig. 1, the stabilizing device 1 is fixedly disposed at the distal end of the injection device 2 for attaching to the surface of the myocardial tissue, and the stabilizing device 1 is provided with an adaptive device 11, so that the stabilizing device 1 can be adaptively deformed to realize the relative stationary motion of the stabilizing device on the myocardial tissue. The stabilizing device 1 further comprises a negative pressure suction device 12 which comprises a suction power source 121 and a suction cavity 122, wherein the suction power source 121 is positioned outside the system, and the self-adaptive device 11 is in gas communication with the suction cavity 122 and the suction power source 121 through an adsorption hole 32 arranged on the guide device 3, so that a negative pressure suction function is realized.

In this embodiment, as shown in fig. 1, the injection device 2 includes an injection assembly 21 and an injection control mechanism 22, the injection assembly 21 includes an injection needle 211, an injection tube 212, and an injection interface 213, the injection needle 211 is fixedly disposed at the distal end of the injection tube 212, the injection interface 213 is fixedly disposed at the proximal end of the injection tube 212, the injection needle 211, the injection tube 212, and the injection interface 213 can form a fluid communication, so that the filler 4 can enter the injection tube 212 from the injection interface 213 and be loaded in the injection needle 211 or be ejected from the injection needle 211, and the injection and filling process of the filler 4 into the target tissue is completed.

In this embodiment, as shown in FIGS. 2-5, injection control mechanism 22 includes an outer tube assembly 221 and a needle exit handle 222. The outer tube assembly 221 comprises an outer tube 2211, an outer tube handle 2212 and a bending control mechanism 2213, the outer tube handle 2212 is fixedly arranged at the proximal end of the outer tube 2211, the outer tube handle 2212 and the bending control mechanism 2213 are axially limited or fixedly connected, and the injection assembly 21 penetrates through the outer tube assembly 221; the needle discharging handle 222 is disposed on the syringe 212, and includes a needle discharging seat 2221, a needle discharging stroke control mechanism 2222, a needle discharging limit control mechanism 2223, and a holding portion 2224, wherein the needle discharging seat 2221, the needle discharging stroke control mechanism 2222, the needle discharging limit control mechanism 2223, and the holding portion 2224 are axially limited or fixedly connected, and the axial movement of the injection assembly 21 is realized by operating the needle discharging handle 222. The outer tube handle 2212, the bend control mechanism 2213 and the needle outlet handle 222 form an integrated large handle.

In this embodiment, as shown in fig. 4, the needle-out stroke control mechanism 2222 includes a stroke control element 22221 and a stroke control operation part 22222, the stroke control element 22221 is connected to the injection tube 212 in a limited or fixed manner, and the stroke control operation part 22222 is operated to extend the injection needle 211 relative to the guide device 3 in a continuous or step-by-step manner, so as to control the stroke of the injection needle 211 extending out of the guide device 3; the needle-out position-limiting control mechanism 2223 includes a position-limiting control member 22231 and a position-limiting control operation part 22232, the position-limiting control member 22231 axially slides relative to the needle-out holder 2221, so that the position-limiting control member 22231 can abut against the stroke-limiting control member 22221, and the needle-out position-limiting control mechanism 2223 limits the maximum stroke of the injection needle 211 extending out of the guide device 3.

In this embodiment, as shown in fig. 5, the distal region of the injection tube 212 is provided with an adaptive bending structure, and the bending control mechanism 2213 comprises a distal fixing element 22131, a bendable section 22132, a bending control element 22133 and a bending control handle 22134, wherein the bendable section 22132 is located at the distal region of the outer tube 2211, and the bendable section 22132 covers the adaptive bending structure partially or completely in the axial direction.

In this embodiment, as shown in fig. 6a-6c, the bending control element 22133 is a bending control tube, the bendable section 22132 of the outer tube 2211 is a plurality of hollowed-out structures a, as shown in fig. 6a, the hollowed-out structures a are strip-shaped through slots, the hollowed-out structures a are parallel to each other and surround the outer tube 2211, the bendable section 22132 of the outer tube 2211 is a plurality of hollowed-out structures B, as shown in fig. 6B, the hollowed-out structures B are similarly strip-shaped through slots, the hollowed-out structures B are parallel to each other and surround the bending control tube, the hollowed-out structures a and the hollowed-out structures B are partially or completely overlapped in the axial direction, but are located on two sides of the tube wall and distributed oppositely, as shown in fig. 6c, the bending control tube is fixedly connected to the distal end of the outer tube 2211 by the distal fixing element 31, the bending control handle 22134 includes a bending control seat 221341, a bending control operation portion 221342 and a bending control element 221343, and a bending control element 221343 is fixedly connected to the proximal end 22133 of the bending control element 22133, bending of the distal portion of the myocardial filling system in at least two directions is achieved by operating the bend control operator 221342 to drive axial movement of the bend control member 221343.

As shown in fig. 7a-7B, when the bending control operation part 221342 is operated to drive the bending control member 221343 to move axially towards the distal end, the bending control member 22133 moves axially towards the distal end at the same time, the hollow-out structures B at the distal end area of the bending control member 22133 are gradually closed to bend the bending control member 22133 to a certain angle in one direction, meanwhile, the hollow-out structures a at the distal end area of the outer tube 2211 are gradually opened to bend the outer tube 211 to the same angle in the other direction, and the bending direction of the distal end portion of the myocardial filling system is shown in fig. 7 a; when the bending control operation part 221342 is operated to drive the bending control member 221343 to move axially towards the proximal end, the bending control member 22133 simultaneously moves axially towards the proximal end, the hollow-out structures B at the distal end area of the bending control member 22133 gradually open to bend the bending control member 22133 to a certain angle towards another direction, simultaneously the hollow-out structures a at the distal end area of the outer tube 2211 gradually close to bend the outer tube 211 to the same angle towards the direction, and the bending direction of the distal end part of the myocardial filling system is shown in fig. 7B.

In this embodiment, the outer diameter OD of the outer tube 2211 is less than or equal to 10mm, the length L is 50-500 mm, and the adjustable bending radius R is less than or equal to 20 mm.

In this embodiment, as shown in fig. 8 and 10, the outer tube 2211 is sealed and wrapped with an outer tube seal 2214 synchronously bending with the bendable section 22132, the distal region of the outer tube seal 2214 is tightly connected to the adaptive device 11, and the proximal region is tightly connected to the distal end of the outer tube handle 2212; a controlled bend pipe sealing piece 22135 is fixedly arranged in the outer pipe handle 2212, the controlled bend pipe 22133 penetrates through the controlled bend pipe sealing piece 22135, and the controlled bend pipe sealing piece 22135 form sliding sealing fit; fixedly attached within bend control 221343 is syringe seal 214, and syringe 212 passes through syringe seal 214 and forms a sliding sealing engagement therewith. The three-dimensional space enclosed by the outer tube sealing piece 2214, the controlled bend sealing piece 22135 and the injection tube sealing piece 214, the injection tube 212 and the outer tube 2211 forms a suction cavity 122, an outer tube handle through hole 22121 is arranged in the outer tube handle 2212, a suction channel is formed by the outer tube handle through hole 22121, the suction hole 32 and the suction cavity 122, and the external suction power source 121 realizes a negative pressure suction function.

In this embodiment, as shown in fig. 10, a control elbow through hole 221331 is provided in control elbow 22133 between the distal end of control elbow seal 22135 and the proximal end of outer tube 2211, and the suction pathway includes control elbow through hole 221331, such that outer tube handle through hole 22121 is in gaseous communication with suction hole 32 via control elbow through hole 221331.

In this embodiment, as shown in fig. 10, the outer tube handle 2212 is provided with an interface 22122, and the interface 22122 realizes the detachable connection between the suction power source 121 and the outer tube handle 2212.

In this embodiment, as shown in fig. 10 to 12, the guiding device 3 is fixedly disposed at the distal end of the outer tube 2211, the injection needle guiding hole 31 and the suction hole 32 are disposed in the guiding device 3, the injection needle guiding hole 31 acts on the directional movement of the injection needle 211, and the injection needle 211 can be extended from the injection needle guiding hole 31 by operating the needle-out handle 222, so as to perform the function of inserting the needle into the target tissue.

In the present embodiment, as shown in FIG. 10, the ratio of the suction hole 32 in the guide 3 is about two thirds of the remaining area excluding the area occupied by the needle guide hole 31, the length in the axial direction of the suction chamber 122 is 50 to 1500mm, and the space in the cross section of the suction chamber 122 is 0.1 to 3mm²The area of the through hole 221331 of the bend control pipe is 3-30 mm²After a plurality of in vitro tests and animal experiment repeatability verification, the stabilizing device can be ensured not to loosen from the surface of the target tissue when being subjected to a large pulling force (such as 15N).

In this embodiment, as shown in fig. 13, the bend-controlling mechanism 2213 is provided with a bend-controlling angle mark, the needle-withdrawing handle 222 is provided with a needle-withdrawing scale mark convenient for an operator to observe, the needle-withdrawing scale mark includes scale marks 22211, a stroke pointer 22223 and/or a limit pointer 22233, the scale marks 22211 are located on a needle-withdrawing seat 2221, the stroke pointer 22223 is fixedly arranged on a stroke control 22221, the limit pointer 22233 is fixedly arranged on a limit control 22231, the limit pointer 22233, the needle-withdrawing seat 2221 and the stroke pointer 22223 are coaxially arranged from far to near, and the actual needle-withdrawing length of the injection needle 211 is determined by determining the position of the stroke pointer 22223.

In this embodiment, as shown in fig. 14, the injection tube 212 can be deformed, a reinforced tube 215 is fixedly disposed from the proximal end region of the injection tube 212 to the injection port 213, and a flexible tube 216 is covered outside the proximal end region of the reinforced tube 215. A plurality of circular grooves C are formed in the middle end area of the reinforcing tube 215, and as shown in fig. 15, the circular grooves C2151 are through holes penetrating through the reinforcing tube 215, are distributed in the middle section area of the reinforcing tube 215 in an opposite manner, and are used for fixedly connecting the injection tube 212 by injecting glue in a gluing manner and the like; a plurality of grooves D are formed in the proximal region of the reinforcing tube 215, and as shown in fig. 16, the grooves D2152 are pi-shaped grooves penetrating the reinforcing tube 215 and spirally distributed in the proximal region of the reinforcing tube 215 to improve the folding resistance of the injection tube 212, and the flexible tube 216 completely covers the grooves D.

In this embodiment, as shown in fig. 9, a local protrusion structure is fixedly disposed on the outer surface of the injection tube 212, and is integrally designed with the injection tube 212, and the protrusion structures are distributed in a dotted manner or in a strip manner, so that the injection tube 212 and the outer tube 2211 form a coaxial sliding fit.

Example two

As shown in fig. 17a to 17c, the present embodiment is based on the first embodiment, and the difference between the present embodiment and the first embodiment is: the needle 211 has shape memory and is pre-shaped in a shape, such as a curved arc, using a flexible metal tube, thereby having both the first and second configurations.

When the needle point of the injection needle 211 is located in the needle guide hole 31, as shown in fig. 17a, it has the first form, i.e. the straight state, so that the injection needle 211 can be safely and smoothly discharged along the needle guide hole 31; the needle withdrawing handle 222 is operated to extend the injection needle 211 from the injection needle guiding hole 31, the injection needle 211 is gradually unfolded in the preset shape until the injection needle is completely withdrawn, as shown in fig. 17b-17c, a second shape, namely a curved arc shape is formed, the function of inserting the needle into the target tissue is easily realized by means of the design of the negative pressure suction device, in the second shape, the cutting edge of the injection needle 211 faces away from the myocardial filling system, the motion track of the injection needle 211 is arc-shaped, and the injection needle guiding hole 31 on the guiding device 3 can ensure that the second shape of the injection needle 211 is kept relatively static relative to the myocardial filling system.

In the embodiment, the inner diameter ID of the injection needle 211 is 0.05-0.4 mm, the wall thickness is 0.01-0.2 mm, and when the injection needle 211 is in the second form, the bending radius R is less than or equal to 8 mm; as shown in fig. 18, the needle guide hole 31 in the guide 3 is sized to fit the outer diameter of the needle 211 with a fit clearance of not more than 0.1 mm.

Example three:

as shown in fig. 19 to 23, the present embodiment is based on the first embodiment, and the present embodiment is different from the first embodiment in that: the adaptation means 11 of the stabilizing device 1 are of a corrugated construction.

In this embodiment, the corrugated structure includes one or more of a circular texture, an arc texture, and a stripe texture. As shown in fig. 19, the annular textures are distributed annularly on the stabilizer 1 in the circumferential direction of the stabilizer, so that the stabilizer 1 is compressible and resilient in the axial direction. When the corrugated structure is an arc-shaped texture, as shown in fig. 20, the arc-shaped texture is annularly distributed in the proximal end region of the stabilizer 1 along the circumferential direction of the stabilizer 1, so that the stabilizer 1 has compressible resilience in the axial direction. As shown in fig. 21a-21b, when the corrugated structure is a strip-shaped texture, the strip-shaped texture is distributed in the distal region of the stabilization device 1 along the direction of inclination toward the distal end, so that the distal portion of the stabilization device 1 has a resilient property that can be expanded, when the stabilization device 1 is in a natural unconstrained state, the corrugated structure is in a fully expanded state, the maximum diameter of which exceeds 10mm, when the stabilization device 1 is in a compressed state, the strip-shaped texture can be stacked in a manner that can be reduced to smoothly enter and exit a lumen with a small inner diameter ID, so as to adapt to various access passages of the myocardial filling system to the myocardial surface, particularly including a 5mm or 10mm puncture cannula lumen equipped for endoscopic surgery.

In a second embodiment, as shown in fig. 22, the stabilizing device 1 is further provided with an enhanced absorption structure 111, and the enhanced absorption structure 111 protrudes outward from the waist region of the adaptive device and converges inward toward the distal end, so that the volume enclosed by the adaptive device is maximized, the absorption efficiency is improved, and the stabilizing device 1 and the target tissue can be maintained in a negative pressure state.

In a third embodiment, as shown in fig. 23, the stabilizing device 1 is further provided with a gradual change structure 112, the gradual change structure 112 is gradually changed from thick to thin at the waist part of the adaptive device and towards the far end region, the wall thickness of the near end region is preferably designed to be 1-1.5 mm, and the wall thickness of the far end region is preferably designed to be 0.2-0.5 mm.

Example four:

as shown in fig. 24, the present embodiment is based on the first embodiment, and the difference between the present embodiment and the first embodiment is: the distal end of the guiding device 3 is fixedly provided with a filtering structure 23. The stabilizing device 1 is fixedly arranged outside the filtering structure 23 to prevent the filtering structure 23 from falling off, the filtering structure 23 is provided with one or more micropores, so that gas can pass through the micropores, liquid can not pass through the micropores, when the myocardial filling system is in a working state, the stabilizing device 1 can still be adsorbed on target tissues, and the adsorption force is basically consistent with that before the filtering structure 23 is not added.

Example five:

as shown in fig. 25, the present embodiment is based on the first embodiment, and the difference between the present embodiment and the first embodiment is: the distal region of the myocardial filling system is provided with a monitoring mechanism 24. The monitoring means 24 is a viewing window 241 penetrating the wall of the outer tube 2211 and the control tube 22133, or the monitoring means 24 is a viewing member 242 made of a material having light transmittance, and the viewing member 242 is a part or all of the injection tube 212, the outer tube 2211, the control tube 22133, the outer tube sealing 2214 and/or the adaptive device, and has the function of assisting in determining the needle insertion effect and the actual injection progress of the filler.

Example six:

as shown in fig. 26, the present embodiment is based on the first embodiment, and the difference between the present embodiment and the first embodiment is:

(1) in this embodiment, the injection tube 212 is a dual lumen structure with one lumen being the loading lumen 2124 and the other lumen being the injection lumen 2125, and a communication port 2126 is provided at the forward end of the injection tube 212, the communication port 2126 placing the loading lumen 2124 in fluid communication with the injection lumen 2125.

(2) In this embodiment, the injection control device 217 is further comprised and comprises an injection piston 2171, a piston rod 2172, and a feed mechanism 2173, the proximal end of the piston rod 2172 is provided with a force application grip 2174 capable of transmitting force in the axial direction, the injection piston 2171 is fixedly disposed at the distal end of the piston rod 2172 so that the injection piston 2171 axially moves in the injection chamber 2125, the injection piston 2171 is in sliding sealing engagement with the injection chamber 2125, the feed mechanism 2173 is disposed at the proximal end of the feed chamber 2124 and is a commercially available three-way valve, and the feed mechanism 2173 is in an open state when the filler 4 is added to the feed chamber 2124; when the myocardial filling system is in the operational state for injection, the feeding device 2173 is in the off state.

The dual-cavity structure has the advantages that the pushing piston push rod 2172 drives the injection piston 2171 to axially move, so that the filler 4 in the injection cavity 2125 can be completely emptied in the injection process, the waste of the filler 5 in the injection cavity 2125 is greatly reduced, the addition of the material supplementing device 2172 can ensure the continuous supplement of the filler 4 in the actual injection process, the injection sustainability of the myocardial filling system is improved, and the safety is improved.

Example seven:

as shown in fig. 27 to 30, the present embodiment is based on the first embodiment, and the difference between the present embodiment and the first embodiment is: in this embodiment, the injection tube 212 is a double-lumen structure, as shown in fig. 28, the double-lumen structure is composed of two layers of tubes, one layer of the tube is a withdrawal judging tube 2121, the other layer of the tube is an injection filling tube 2122, the distal region of the double-lumen structure is wrapped by a fixing tube 2123 made of the same material, the contact parts of the withdrawal judging tube 2121, the injection filling tube 2122 and the fixing tube 2123 are connected together by thermal fusion to prevent leakage of the filling material 4 or liquid during injection due to a gap between the tubes, the injection needle 211 is fixedly disposed at the distal end of the injection tube 212, the proximal end of the injection needle 211 is not in contact with the withdrawal judging tube 2121 and the injection filling tube 2122, a certain gap is left, the proximal ends of the withdrawal judging tube 2121 and the injection filling tube 2122 are respectively connected with the connectors 213, the injection needle 211, the injection tube 212 and the injection connector 213 can form fluid communication, during injection, when the injection needle 211 penetrates into a target tissue, the withdrawal judging tube 2121 can be preferentially used for performing a withdrawal test, the safety is determined and the injection of the filler 4 is performed using the injection filling tube 2122.

The advantage of above-mentioned two-layer pipe integrated design lies in, at the injection in-process, can preferentially use the pumpback to judge the pipe and carry out the pumpback and judge, confirms whether the present position of syringe needle satisfies the injection, avoids the syringe needle to prick target tissue, reduces the risk that the injection pricked, improves the security of system, reuses the injection filling tube afterwards and injects, improves the injection efficiency of system.

In another embodiment, as shown in fig. 28, both the retraction determining tube 2121 and the injection filling tube 2122 can be deformed adaptively, the proximal regions of the retraction determining tube 2121 and the injection filling tube 2122 are respectively and fixedly provided with the reinforced tube 215 at the position of the interface 213, the middle region of the reinforced tube 215 is provided with a plurality of circular grooves C, as shown in fig. 29, the circular grooves C2151 are through holes penetrating through the reinforced tube 215 and are oppositely distributed in the middle region of the reinforced tube 215 for fixedly connecting the injection tube 212; the proximal region of the reinforcing tube 215 is provided with a plurality of grooves D, as shown in fig. 30, the grooves D2152 are pi-shaped grooves penetrating the reinforcing tube 215 and spirally distributed in the proximal region of the reinforcing tube 215 for improving the folding resistance of the injection tube 212, and the proximal region of the reinforcing tube 215 is covered with a layer of flexible tube 216 to completely cover the grooves D.

Example eight:

as shown in fig. 31-32, the present embodiment is based on the first embodiment, and the difference between the present embodiment and the first embodiment is: (1) the bend-controlling member 22133 is a bend-controlling wire axially laid in the wall of the outer tube 2211; (2) the aspiration lumen 122 is formed from a single tube; (3) the bend control handle 22134 is not axially aligned with the outer tube handle 2212.

In this embodiment, as shown in fig. 31, the bending control handle 22134 includes a bending control seat 221341, a bending control operation portion 221342 and a bending control member 221343, the bending control member 221343 is fixedly connected to the proximal end of the bending control member 22133, the injection assembly 21 penetrates through the outer tube assembly 221, and the bending control operation portion 221342 is operated to drive the bending control member 221343 to move, so as to drive the bending control member 22133 to move, thereby achieving bending of the distal portion of the myocardial filling system.

In this embodiment, as shown in fig. 32, the suction cavity 122 is formed by a single tube, and is a hollow cavity disposed between the outer tube 2211 and the injection tube 212, the distal end of the suction cavity 122 is flush with the distal end of the outer tube 2211, the proximal end of the suction cavity 122 is fixedly disposed on the outer tube handle 2212, an outer tube handle through hole 22121 is disposed in the outer tube handle 2212, the outer tube handle through hole 22121, the suction cavity 122 and the suction hole 32 form a suction channel, an interface 22122 is disposed on the outer tube handle 2212, and the interface 22122 realizes detachable connection of the suction power source 121 and the outer tube handle 2212.

The suction cavity 122 of this single tubular product designs has the advantage that, suction cavity 122 comprises fixed tubular product, and the lumen size can not change along with the change of the cavity volume between outer tube and the injection syringe, can keep the stability of suction efficiency, and the reducible each connecting piece interconnect of design of tubular product simultaneously causes the gap, reinforcing stabilising arrangement's absorption efficiency.

Example nine:

as shown in fig. 33, the present embodiment is based on the first embodiment, and the difference between the present embodiment and the first embodiment is: the needle output handle 222 includes a needle output holder 2221, a needle output stroke control mechanism 2222, and a holding portion 2224, the needle output holder 2221 and the outer tube handle 2212 are axially connected in a limited manner, and the needle output stroke control mechanism 2222 includes a push button 22224, a stroke controller 22225, a stroke controller fixing member 22226, and a stroke guide 22227.

In this embodiment, the stroke controller 22225 is fixedly connected to the syringe 212, the distal end region of the grip portion 2224 is fixedly provided with a groove 22241, the depth of the distal end region of the groove 22241 is deeper than that of the proximal end region, which is the thickness of the stroke guide 22227 but does not penetrate through the grip portion 2224, the stroke guide 22227 is ratchet-shaped and is fixedly arranged in the distal end region of the groove 22241, the proximal end region of the groove 22241 is provided with a through hole 22242 penetrating through the grip portion, the push button 22224 is arranged in the groove 22241, the stroke controller 22225 and the push button 22224 are fixedly connected through the stroke controller fixing part 22226, the push button 22224 can slide on the groove 22241 and the stroke guide 22227, and the push button 22224 is operated to make the syringe needle 211 extend step by step relative to the guide 3, thereby realizing the stroke control of the syringe needle 211 extending out of the guide 3.

The embodiments of the present invention have been described in detail, but the embodiments are merely examples, and the present invention is not limited to the embodiments described above. Any equivalent modifications and substitutions to those skilled in the art are also within the scope of the present invention. Accordingly, equivalent changes and modifications made without departing from the spirit and scope of the present invention should be covered by the present invention.

Claims

1. A myocardial filling system, characterized by comprising a stabilizing device (1), an injection device (2), a guiding device (3) and a filling (4); wherein

The stabilizing device (1) at least comprises an adaptive device which is fixedly arranged at the far end of the myocardial filling system, the adaptive device is provided with a shape adaptive structure, and when the adaptive device is attached to the surface of myocardial tissue, the relative position of the myocardial filling system on the myocardial tissue is limited;

the injection device (2) comprises at least an injection assembly (21), the injection assembly (21) comprises an injection needle (211), an injection tube (212) and an injection control device (217), and the filler (4) realizes controllable injection to the myocardial tissue through the injection assembly (21);

the guiding device (3) is fixedly arranged at the far end region of the myocardial filling system and is positioned in the self-adaptive device, an injection needle guiding hole (31) which forms sliding fit with the injection needle (211) is arranged on the guiding device, and the functions of positioning and needle discharging of the injection needle (211) on myocardial tissues are realized.

2. The myocardial filling system according to claim 1, characterized in that the stabilizing device (1) comprises a negative pressure suction device (12), the negative pressure suction device (12) comprises a suction power source (121) and a suction cavity (122), the suction power source (121) is located outside the myocardial filling system, the guiding device (3) is provided with an adsorption hole (32), and the adaptive device is in gas communication with the adsorption hole (32), the suction cavity (122) and the suction power source (121) to realize a negative pressure suction function.

3. The myocardial filling system according to claim 1, characterized in that the injection device (2) includes an injection control mechanism (22), the injection control mechanism (22) includes an outer tube assembly (221) and a needle exit handle (222), the outer tube assembly includes an outer tube (2211), an outer tube handle (2212) and a bend control mechanism (2213), the outer tube handle (2212) is fixedly disposed at a proximal end of the outer tube (2211), the injection assembly (21) penetrates the outer tube assembly (221), and the needle exit handle (222) is disposed on the injection tube (211).

4. A myocardial filling system according to claims 1-3, wherein the injection needle has two forms, a first form in which the needle point of the injection needle (211) is straight when located in the needle guide hole, and a second form in which the needle (211) is curved after protruding out of the needle guide hole; the needle guiding bore (31) on the guiding means (3) ensures that the second form of the injection needle remains relatively stationary with respect to the myocardial filling system.

5. The myocardial filling system according to claim 1, characterized in that the adaptive means (11) of the stabilization means (1) is a corrugated structure comprising one or several of a circular texture, an arc texture, a stripe texture; wherein the annular and/or arcuate texture is distributed annularly on the stabilizer (1) in the circumferential direction of the stabilizer, so that the stabilizer (1) has a compressible resilience in the axial direction; the strip-shaped textures are distributed in the distal end area of the stabilizing device (1) along the direction inclined towards the distal end, so that the distal end part of the stabilizing device (1) has the elasticity capable of expanding and increasing in the radial direction; or the adaptive means are directly made of a resilient material.

6. The myocardial filling system according to claim 4, characterized in that the distal region of the injection tube (212) is provided with an adaptive bend structure, the bend-controlling mechanism (2213) comprising a distal fixation (22131), a bendable segment (22132), a bend-controlling piece (22133) and the bend-controlling handle (22134); wherein the bendable section (22132) is located at a distal region of the outer tube (2211), the bendable section (22132) partially or fully covering the adaptively bent structure in an axial direction; the distal end of the bending control piece (22133) is fixedly connected with the outer tube (2211) through the distal fixing piece (22131); the bending control handle (22134) comprises a bending control operation part (221342), a bending control piece (221343) and a bending control seat (221341), and the proximal end of the bending control piece (22133) is connected with the bending control piece (221343); operating the bending control operation part (221342), wherein the bending control piece (221343) drives the bending control piece (22133) to move axially to realize the bending of the distal part of the myocardial filling system; the bending control piece (22133) is a bending control wire which is axially laid in the wall of the outer pipe (2211) or outside the outer pipe (2211), or the bending control piece (22133) is a bending control pipe which is sleeved in the outer pipe (2211).

7. The myocardial filling system according to claim 6, characterized in that the bending control member (22133) is a bending control tube sleeved in the outer tube (2211), the outer tube (2211) and the bending control tube are coaxially and slidably fitted, the bendable section (22132) of the outer tube (2211) is a plurality of hollowed-out structures A, the hollowed-out structures A are narrow strip-shaped through grooves, and the hollowed-out structures A are parallel to each other and surround the outer tube (2211); in the bendable section (22132) of the outer tube (2211), the control bending tube is provided with a plurality of hollow structures B, the hollow structures B are strip-shaped through grooves, the hollow structures B are parallel to each other and surround the control bending tube, and the hollow structures A and the hollow structures B are partially or completely overlapped in the axial direction and are respectively located on two sides of the tube wall.

8. The myocardial filling system according to claim 7, characterized in that, outside the bendable section (22132) area of the outer tube (2211), a sealing wrap is wrapped with an outer tube seal (2214) that bends synchronously with the bendable section (22132); a control elbow sealing piece (22135) is fixedly connected in the outer pipe handle (2212), the control elbow (22133) penetrates through the control elbow sealing piece (22135) and forms sliding sealing fit with the control elbow sealing piece (22135); a syringe seal (214) is arranged on the bending control element (221343), the syringe (212) passes through the syringe seal (214) and forms a sliding sealing fit with the syringe seal; the outer tube sealing piece (2214), the control elbow sealing piece (22135) and the injection tube sealing piece (214), and a three-dimensional space enclosed by the injection tube (212) and the outer tube (2211) form the suction cavity (122), and the suction hole (32), the suction cavity (122) and an outer tube handle through hole (22121) arranged in the outer tube handle (2212) form a suction channel.

9. The myocardial filling system according to claim 8, wherein a control elbow through hole (221331) is provided on the control elbow (22133) between the distal end of the control elbow seal (22135) and the proximal end of the outer tube (2211), the suction channel including the control elbow through hole (221331) such that outer tube handle through hole (22121) is in gaseous communication with the suction hole (32) via the control elbow through hole (221331).

10. The myocardial filling system according to claim 1, characterized in that the outer surface of the injection tube (212) is fixedly provided with local convex structures, and the local convex structures are designed as a whole with the injection tube (212), and the convex structures are distributed in a point shape or a strip shape, so that the injection tube (212) and the outer tube (2211) form a coaxial sliding fit.

11. The myocardial filling system according to claim 3, wherein the needle-out handle (222) includes a needle-out base (2221), a needle-out stroke control mechanism (2222), and/or a needle-out limit control mechanism (2223); the needle outlet base (2221) is axially limited or fixedly connected with the outer tube handle (2212) or the bending control mechanism (2213); the needle-out stroke control mechanism (2222) realizes the stroke control of the injection needle (211) extending out of the guide device (3); the needle-out limit control mechanism (2223) limits the maximum travel of the injection needle (211) out of the guide device (3).

12. The myocardial filling system according to claim 11, wherein the needle-out stroke control mechanism (2222) includes a stroke control part (22221) and a stroke control operation part (22222), the stroke control part (22221) is connected with the syringe (212) in a limiting or fixed manner, and the stroke control operation part (22222) is operated to ensure that the injection needle (211) is extended in a stepping or continuous manner relative to the guide device (3) so as to realize the stroke control of the injection needle (211) extending out of the guide device (3); the needle-out limit control mechanism (2223) comprises a limit control element (22231) and a limit control operation part (22232), the limit control element (22231) axially slides relative to the needle-out seat (2221) so that the limit control element (22231) can abut against the stroke control element (22221), and the needle-out limit control mechanism (2223) limits the maximum stroke of the injection needle (211) extending out of the guide device (3).

13. The myocardial filling system according to claim 12, wherein a bending control angle mark is provided on the bending control mechanism (2213), or a needle-out scale mark which is convenient for an operator to observe is provided on the needle-out handle (222), the needle-out scale mark comprises a scale mark (22211), a stroke pointer (22223) and/or a limit pointer (22233), the scale mark (22211) is located on a needle-out seat (2221), the stroke pointer (22223) is fixedly arranged on the stroke control element (22221), and the limit pointer (22233) is fixedly arranged on the limit control element (22231).

14. The myocardial filling system according to claim 1, characterized in that the guiding means (3) is fixedly provided with a filter structure (23) at a distal end, the filter structure (23) having one or more micro-holes such that gas can pass through the micro-holes and liquid cannot pass through the micro-holes.

15. The myocardial filling system according to claim 1, characterized in that the distal region of the myocardial filling system is provided with a monitoring means (24), the monitoring means (24) being a visual window (241) through the tube wall of the outer tube (2211) and the control bend (22133), or the monitoring means (24) being a viewing part (242) made of a material with light transparency, the viewing part (242) being part or all of the injection tube (212), the outer tube (2211), the control bend (22133), the outer tube seal (2214) and/or the adaptive means (11).