A myocardial filling system

Abstract

The present invention relates to a myocardial filling system, comprising a stabilizing device, an injection device, a guide device and a filler, the injection device comprising an injection assembly, an outer tube assembly and a needle removal handle, the injection needle, injection tube and injection interface of the injection assembly being fluidically connected so that the filler enters from the injection interface and is ejected from the injection needle, the guide device is provided with an injection needle guide hole and an adsorption hole, the needle removal handle is operated so that the injection needle extends from the injection needle guide hole, thereby achieving a needle-piercing function into the target tissue, the stabilizing device further comprising a negative pressure suction device, the negative pressure suction device comprising a suction power source and a suction chamber, the suction power source being located outside the myocardial filling system, the adsorption hole and the suction source forming a gas connection through the suction chamber to achieve negative pressure suction, the stabilizing device being provided with an adaptive device so that the stabilizing device undergoes adaptive deformation to facilitate formation of negative pressure between the stabilizing device and the target tissue. The present invention has convenient targeted acupuncture, controllable injection depth, safe and reliable injection, and excellent filling effect.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a myocardial injection filling system. Background Art

[0002] In medical fields such as minimally invasive surgeries for tissue injection and filling, the key to treatment is to use a suitable injection device or filling system to inject a specific amount or volume of injectables (including fillers) into the target area or specific location (including injection depth) of the tissue to be treated or repaired. Tissues suitable for injection and filling are mainly divided into two categories. The first category is facial or external tissues that are mostly used for modification or beauty purposes, such as cheeks, forehead, nose, chest, buttocks, etc. The second category is internal tissues or organs that have emerged in recent years for the purpose of disease treatment or repair, such as the myocardial wall and blood vessel wall. The above-mentioned tissues have a certain degree of elasticity, but are mostly dense structures. In general, suitable injectables have a certain degree of fluidity but a high viscosity. If traditional syringes are used to inject such injectables, including commercialized hyaluronic acid gels and alginate-based hydrogels that have initial clinical application value, it will result in: 1) Due to the viscosity of the injectable High, it is necessary to select a thicker injection needle (such as OD ≥ 0.5mm) so that the injection material can be pushed out from the injection tube through the injection needle more easily. However, when the syringe with a thicker injection needle is inserted into the tissue, the trauma is greater, and the needle hole left on the tissue after the needle is withdrawn is not easy to heal, which is obviously not in line with the development trend of minimally invasive surgery. Of course, the remaining larger needle hole is prone to leakage of the injection material, which not only affects the effectiveness of the operation, but also easily leads to wound infection or tissue adhesion with the tissue or organ that may be in contact with it and other safety issues. Thinner injection needles have many disadvantages, including: ① The needle is prone to bending or even High risk of needle breakage; ② The inner cavity of the injection needle for the injection of the injection is too small, making it difficult to push the injection from the injection tube, and the simple design of the traditional syringe with a piston and piston rod is difficult to meet this demanding requirement; ③ In order to achieve the effectiveness of the injection filling operation, the amount of the injection needs to reach a certain value, usually from several milliliters to hundreds of milliliters. For this, it is necessary not only to select and locate the target tissue surface multiple times, but also to perform a specific amount of controlled injection at each target point. In particular, for myocardial injection filling, up to 20 times of point selection and target positioning are required. The preferred operation channels for this operation include: through the small chest Minimally invasive approaches, such as laparoscopic incisions to reach the outer surface of the heart (epicardium), and interventional approaches, such as transfemoral access and traversal of the arterial system to reach the inner surface of the heart (endocardium of the left ventricle), are available. However, the heart is a complex three-dimensional structure with curved and uneven inner and outer surfaces. Furthermore, the limitations of these minimally invasive operation channels make multiple point selection and accurate targeting extremely challenging, making them impossible with traditional syringes. Furthermore, up to 20 injections require the surgeon to quickly and easily reload the syringe with the injectable material. Traditional syringes use a piston-pulling method to draw the injectable material from the needle into the syringe, which is both time-consuming and laborious.2) The high viscosity of the injection will inevitably lead to its poor diffusion. When the target area is muscle tissue, the difficulty of injection will be greatly increased. At the same time, during the injection process, the self-tension of the tissue will force the injection to be squeezed out of the tissue along the outer wall of the injection needle, causing a large amount of injection leakage. Therefore, it is impossible to ensure the controllable injection volume of the injection; 3) When performing myocardial injection filling surgery, the target area is the myocardial wall of the heart, and the heart is a continuously beating organ. In addition to the self-tension of the myocardial tissue, the beating of the heart itself will continuously squeeze the injection that has been injected from the injection needle, making the injection squeezed to the surface of the heart during the injection process. The risk of leakage is greatly increased. Of course, with the continuous beating of the heart, when the injection is injected During myocardial injection, the needle tip's position can easily shift, making it difficult to accurately and effectively control the injection depth, thus impacting the effectiveness of the injection procedure. Furthermore, the needle can potentially penetrate the entire heart wall, causing the injection to accidentally enter natural cavities such as the atria and ventricles. This can ultimately cause the injection to flow into and block small blood vessels in the brain, leading to ischemic stroke or limb blood vessels, causing ischemic necrosis and other safety incidents. Furthermore, the heart's constant and high-amplitude beating can easily cause the needle to completely dislodge from the myocardial tissue, disrupting and prolonging the procedure, and posing a risk to the patient's or the target population's safety.

[0003] To achieve various technical objectives, those skilled in the art have attempted to improve upon conventional syringes. For example, patent CN200780034572 discloses a disposable syringe with a needle that retracts into a plunger after use. When the needle is retracted, the syringe is sealed to prevent leakage from the needle or any liquid remaining within it. The pierceable seal provided at the front of the plunger is self-sealing, preventing any liquid from leaking from the front of the syringe, and the distal end of the plunger seals against the rear of the syringe barrel to prevent leakage from the rear. The technical objectives of this design are: first, to prevent medical personnel from being stabbed when injecting hazardous materials; and second, to prevent leakage of hazardous materials from the syringe after the needle is retracted. However, the above technical solution has the following defects: First, the front end area of ​​the syringe body provided by this technical solution is hollow. Since it is impossible to prevent the injection in the tissue from leaking, the leaked material will enter this area and cause secondary pollution; second, the seal is arranged inside the syringe body, and there is a dead angle between the seal and the needle holder. When the viscosity of the injection is high, the seal will be subjected to greater resistance when the plunger is pushed, and the dead zone volume will increase; third, the syringe is not suitable for minimally invasive surgery or interventional surgery. First, it cannot adapt to the curved channels of the human body, and second, it cannot be injected multiple times. If multiple injections are required, new syringes need to be replaced multiple times to enter and exit the human body, which will cause damage to the human body channel; fourth, the syringe cannot accurately determine the actual position of the injection needle. During the pushing process, it can only rely on the operator to control the pushing distance; fifth, the syringe has no depth limiting structure. Because its injection needle is a straight needle, it may cause uncertainty in the needle insertion depth, thereby increasing the risk; sixth, the syringe is only suitable for one-time use and cannot complete continuous injection.

[0004] Therefore, the existing technology has problems such as leakage of injection material, inability to accurately control injection volume and injection depth, and insufficient operating space. Summary of the Invention

[0005] In order to overcome the above-mentioned defects of the prior art, the purpose of the present invention is to provide a myocardial filling system for assisting the injection of injections with higher viscosity in different spaces, so as to solve the problems of injection leakage, uncontrollable injection volume and injection depth, inaccurate needle insertion depth, insufficient operating space, etc. during injection in the prior art.

[0006] The technical objectives of the present invention are achieved through the following technical solutions:

[0007] A myocardial filling system comprises a stabilizing device, an injection device, a guiding device and a filler; wherein

[0008] The stabilizing device at least includes an adaptive device, which is fixedly arranged at the distal end of the myocardial filling system and has a morphologically adaptive structure. When the adaptive device is attached to the surface of the myocardial tissue, the relative position of the myocardial filling system on the myocardial tissue is defined;

[0009] The injection device at least comprises an injection assembly, which comprises an injection needle, an injection tube and an injection control device, and the filler is controllably injected into the myocardial tissue through the injection assembly;

[0010] The guide device is fixedly arranged in the distal area of ​​the myocardial filling system and is located in the adaptive device. The guide device is provided with an injection needle guide hole that forms a sliding fit with the injection needle, thereby realizing the positioning and needle removal functions of the injection needle on the myocardial tissue.

[0011] Preferably, the stabilization device includes a negative pressure suction device, which includes a suction power source and a suction chamber. The suction power source is located outside the myocardial filling system. The guide device is provided with an adsorption hole. The adaptive device forms a gas connection with the adsorption hole, the suction chamber, and the suction power source to realize the negative pressure suction function.

[0012] Preferably, the injection device includes the injection control mechanism, the injection control mechanism includes an outer tube assembly and a needle removal handle, the outer tube assembly includes an outer tube, an outer tube handle and a bending control mechanism, the outer tube handle is fixedly arranged at the proximal end of the outer tube, the injection assembly passes through the outer tube assembly, and the needle removal handle is arranged on the injection tube.

[0013] Preferably, the injection needle has two forms: a first form that is straight when the needle tip is located in the injection needle guide hole; and a second form that is curved after the injection needle extends out of the injection needle guide hole; the injection needle guide hole on the guide device ensures that the second form of the injection needle remains relatively stationary relative to the myocardial filling system.

[0014] Preferably, the adaptive device of the stabilizing device is a corrugated structure, and the corrugated structure includes one or more of annular texture, arcuate texture, and strip texture; wherein the annular texture and / or arcuate texture are distributed in an annular shape on the stabilizing device along the circumferential direction of the stabilizing device, so that the stabilizing device has compressible resilience in the axial direction; the strip texture is distributed in the distal area of ​​the stabilizing device along the inclined direction toward the distal end, so that the distal part of the stabilizing device has resilience that can be expanded in the radial direction; or the adaptive device is directly made of a material with resilience.

[0015] Preferably, the distal region of the injection tube is provided with an adaptive bending structure, and the bending control mechanism includes a distal fixing part, a bendable section, a bending control part and the bending control handle; wherein, the bendable section is located in the distal region of the outer tube, and the bendable section partially or completely covers the adaptive bending structure in the axial direction; the distal end of the bending control part is fixedly connected to the outer tube through the distal fixing part; the bending control handle includes a bending control operating part, a bending control part and a bending control seat, and the proximal end of the bending control part is fixedly connected to the bending control part; when the bending control operating part is operated, the bending control part drives the bending control part to move axially, thereby realizing the bending of the distal part of the myocardial filling system; the bending control part is a bending control wire axially laid inside the outer tube wall or outside the outer tube, or the bending control part is a bending control tube sleeved inside the outer tube.

[0016] Preferably, the bending control part is a bending control tube sleeved inside the outer tube, the outer tube and the bending control tube are coaxially slidably matched, the bendable section of the outer tube is a plurality of hollow structures A, the hollow structure A is a narrow strip-shaped through groove, the plurality of hollow structures A are parallel to each other and surround the outer tube; within the bendable section of the outer tube, the bending control tube is provided with a plurality of hollow structures B, the hollow structure B is a narrow strip-shaped through groove, the plurality of hollow structures B are parallel to each other and surround the bending control tube, the plurality of hollow structures A and the plurality of hollow structures B partially or completely overlap in the axial direction, but are separated on both sides of the tube wall.

[0017] Preferably, the outside of the bendable section area of ​​the outer tube is sealed and coated with an outer tube seal that bends synchronously with the bendable section; a bending control tube seal is fixedly connected to the outer tube handle, the bending control tube passes through the bending control tube seal and the two form a sliding seal; an injection tube seal is provided on the bending control component, the injection tube passes through the injection tube seal and the two form a sliding seal; the outer tube seal, the bending control tube seal and the injection tube seal, together with the three-dimensional space enclosed by the injection tube and the outer tube, form the suction cavity, and the adsorption hole, the suction cavity and the outer tube handle through hole provided in the outer tube handle form a suction channel.

[0018] Preferably, a bending control tube through hole is provided on the bending control tube located between the distal end of the bending control tube seal and the proximal end of the outer tube, and the suction channel includes the bending control tube through hole, so that the outer tube handle through hole and the adsorption hole are gas-connected via the bending control tube through hole.

[0019] Preferably, a local raised structure is fixedly provided on the outer surface of the injection tube, which is designed as an integral unit with the injection tube. The raised structure is distributed in a point-like or strip-like manner, so as to facilitate coaxial sliding fit between the injection tube and the outer tube.

[0020] Preferably, the needle ejection handle includes a needle ejection seat, a needle ejection stroke control mechanism and / or a needle ejection limit control mechanism; wherein, the needle ejection seat is axially limitedly connected or fixedly connected to the outer tube handle or the bending control mechanism; the needle ejection stroke control mechanism realizes the stroke control of the injection needle extending out of the guide device; the needle ejection limit control mechanism limits the maximum stroke of the injection needle extending out of the guide device.

[0021] Furthermore, the needle removal stroke control mechanism includes a stroke control member and a stroke control operating part. The stroke control member is connected or fixedly connected to the injection tube limit. The stroke control operating part is operated so that the injection needle is extended step by step or continuously relative to the guide device, thereby realizing the stroke control of the injection needle extending out of the guide device; the needle removal limit control mechanism includes a limit control member and a limit control operating part. The limit control member realizes axial sliding relative to the needle removal seat so that the limit control member can abut against the stroke control member. The needle removal limit control mechanism limits the maximum stroke of the injection needle extending out of the guide device.

[0022] Preferably, a bending control angle mark is provided on the bending control mechanism, or a needle ejection scale mark is provided on the needle ejection handle for easy observation by the operator. The needle ejection scale mark includes a scale line, a travel pointer and / or a limit pointer. The scale line is located on the needle ejection seat, the travel pointer is fixedly set on the travel control component, and the limit pointer is fixedly set on the limit control component.

[0023] Preferably, a filter structure is fixedly provided at the distal end of the guide device, and the filter structure has one or more micropores, so that gas can pass through the micropores but liquid cannot pass through the micropores.

[0024] Preferably, a monitoring mechanism is provided in the distal region of the myocardial filling system, and the monitoring mechanism is a visual window penetrating the tube wall of the outer tube and the bend control tube, or the monitoring mechanism is an observation component made of a light-transmitting material, and the observation component is part or all of the injection tube, the outer tube, the bend control tube, the outer tube seal and / or the adaptive device, which has the effect of assisting in observing the needle insertion position.

[0025] Compared with the prior art, the beneficial effects of the present invention are mainly reflected in:

[0026] 1. The negative pressure adsorption device provided by the present invention forms a negative pressure state between the stabilizing device and the target tissue through the negative pressure suction device when injecting fillers, especially fillers with high viscosity, into non-cavity areas of human tissue, such as muscles, or moving human tissues such as the myocardium. This fundamentally prevents the phenomenon of the filler being squeezed out of the injection area due to poor diffusion of the filler in the tissue or accompanied by the self-tension or movement force of the tissue during the injection process, that is, the filler leaking back from the human tissue in this area. This ensures that the injection volume entering the target tissue is precisely controlled, ultimately maximizing the degree of tissue filling. Therefore, the injection of the present invention is safe, reliable and controllable, and the filling effect is excellent.

[0027] 2. The stabilizing device provided by the present invention is provided with an adaptive device, so that the stabilizing device undergoes adaptive deformation after being abutted against the surface of the target tissue, completely avoiding the situation where the stabilizing device is difficult or impossible to pierce due to the difference in the surface morphology of the target tissue at different puncture points, or the different inclination angles of the myocardial filling system relative to the target tissue, thereby avoiding the needling angles. Ultimately, it ensures that the targeted puncture and subsequent injection filling operations go smoothly. At the same time, after the puncture, the adaptive device continuously undergoes adaptive changes with the continuous beating of the heart, so that the negative pressure state is maintained between the stabilizing device and the target tissue, so that the negative pressure suction device can continue to effectively exert its intended function.

[0028] 3. The injection needle provided in the present invention has both the first form and the second form, and the injection needle cooperates with the guide device, which facilitates the injection needle to be safely and smoothly withdrawn along the injection needle guide hole of the guide device, thereby achieving accurate positioning of the targeted injection point on the target tissue and avoiding the high risk of needle bending or breaking. With the help of the needle withdrawal stroke control mechanism, the injection needle can be easily and quickly inserted into the target tissue, achieving the performance characteristics of convenient targeted needle insertion, easy withdrawal of the injection needle, and safety and reliability of the entire process; in addition, after the injection needle extends out of the injection needle guide hole, the injection needle with the second form is in a curved arc shape, which helps the injection needle to remain relatively still with the target tissue under the continuous beating of the heart, prevents accidental needle removal during the needle insertion and injection process, and avoids the occurrence of filler leakage incidents.

[0029] 4. The needle-extraction limit control mechanism provided in the present invention can control the maximum depth of the injection needle's penetration into the target tissue according to actual clinical needs. That is, by controlling the needle-extraction limit control mechanism to send the injection needle to a predetermined depth, the injection depth of the injection needle can be accurately controlled to avoid excessive penetration, which may cause the needle tip of the injection needle to penetrate the entire target tissue, such as the myocardial wall, causing the filler to be unexpectedly injected outside the target tissue, such as into the blood in the ventricular cavity or coronary artery, and ultimately causing a life-threatening medical accident. The present invention is easy to operate and has safe and reliable injection.

[0030] 5. The bending adjustment mechanism and bending angle control marker provided in the present invention are suitable for minimally invasive surgery or interventional surgery, and are particularly suitable for myocardial injection filling surgery that requires multiple point selections, targeted positioning, and precise control of injection depth and injection volume, thereby realizing multi-directional and multi-operation space injection of the myocardial filling system. Therefore, the present design is structurally reliable, safe, fast, and controllable in operation.

[0031] 6. The present invention provides a detachable connection structure between the feeding device and the injection assembly, so that during the injection process, the injection material can be filled, loaded and injected multiple times in a timely manner.

[0032] 7. The technical solution provided by the present invention, especially the stabilization device and the adaptive device, can achieve the successful injection of highly viscous injections without increasing the diameter of the injection needle, and has the advantage of low or almost no leakage from human tissue. It is suitable for minimally invasive surgery or interventional surgery, especially minimally invasive surgery in which myocardial injection and filling are performed through a small chest incision under laparoscopy to reach the outer surface of the heart. It does not affect the opening size of the above-mentioned surgery and reduces the surgical risk. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 Schematic diagram of the overall structure of the myocardial filling system in Example 1 of the present invention;

[0034] Figure 2 This is an overall appearance diagram of the handle in Example 1 of the present invention;

[0035] Figure 3 This is a cross-sectional view of the handle along the axis of the suction channel in Example 1 of the present invention;

[0036] Figure 4 Schematic cross-sectional view of the needle removal handle in the first embodiment of the present invention;

[0037] Figure 5 Schematic cross-sectional view of the outer tube assembly in Example 1 of the present invention;

[0038] Figure 6a This is a schematic diagram of a specific implementation of the bendable section on the outer tube in Example 1 of the present invention;

[0039] Figure 6b This is a schematic diagram of a specific implementation of the bendable section on the bending control member in Example 1 of the present invention;

[0040] Figure 6c Schematic cross-sectional view of the placement relationship between the outer tube and the bending control member in the first embodiment of the present invention;

[0041] Figures 7a-7b This is a schematic diagram of a specific implementation of the bending direction of the myocardial filling system in Example 1 of the present invention;

[0042] Figure 8Schematic cross-sectional view of the inner seal of the outer tube assembly in Example 1 of the present invention.

[0043] Figure 9 Schematic cross-sectional view of the injection tube in Example 1 of the present invention;

[0044] Figure 10 Schematic diagram of the structure of the suction channel in Example 1 of the present invention.

[0045] Figure 11 This is a front view of the guide device in Example 1 of the present invention;

[0046] Figure 12 This is a rear view of the guide device in Example 1 of the present invention;

[0047] Figure 13 Schematic diagram of scale marking in Example 1 of the present invention;

[0048] Figure 14 Schematic cross-sectional view of the reinforced area of ​​the injection tube in Example 1 of the present invention;

[0049] Figure 15 Schematic cross-sectional view of the circular groove C in the middle end area of ​​the reinforcement tube in the first embodiment of the present invention.

[0050] Figure 16 Schematic diagram of a specific implementation of the groove D in the proximal region of the reinforcing tube in Example 1 of the present invention.

[0051] Figures 17a-17c This is a schematic diagram of a specific implementation of the injection needle removal state in Example 2 of the present invention.

[0052] Figure 18 This is a cross-sectional view of the guide device along the axis of the injection needle guide hole in Example 2 of the present invention.

[0053] Figure 19 This is a schematic diagram of a specific implementation of the corrugated structure in Example 3 of the present invention.

[0054] Figure 20 This is a schematic diagram of a specific implementation of the corrugated structure in Example 3 of the present invention.

[0055] Figures 21a-21b This is a schematic diagram of a specific implementation of the corrugated structure in Example 3 of the present invention.

[0056] Figure 22 This is a schematic diagram of a specific implementation of the enhanced adsorption structure in Example 3 of the present invention.

[0057] Figure 23 This is a schematic diagram of a specific implementation of the wall thickness gradient structure in Example 3 of the present invention.

[0058] Figure 24This is a schematic diagram of a specific implementation of the filtering structure in Example 4 of the present invention.

[0059] Figure 25 This is a schematic diagram of a specific implementation of the monitoring mechanism in Example 5 of the present invention.

[0060] Figure 26 This is a schematic diagram of a specific implementation of the injection control device in Example 6 of the present invention.

[0061] Figure 27 This is a schematic diagram of a specific implementation of the double-lumen injection tube in Example 7 of the present invention.

[0062] Figure 28 Schematic cross-section of the reinforced area of ​​the double-lumen injection tube in Example 7 of the present invention.

[0063] Figure 29 Schematic cross-sectional view of the circular groove C in the middle end area of ​​the reinforcement tube in the seventh embodiment of the present invention.

[0064] Figure 30 This is a schematic diagram of a specific implementation of the groove D in the proximal area of ​​the reinforcement tube in Example 7 of the present invention.

[0065] Figure 31 This is a schematic diagram of a specific implementation of the outer tube assembly in Example 8 of the present invention.

[0066] Figure 32 This is a schematic diagram of a specific implementation of the suction channel in Example 8 of the present invention.

[0067] Figure 33 This is a schematic diagram of a specific implementation of the needle removal handle in Example 9 of the present invention.

[0068] Markings in the figure indicate:

[0069] 1-Stabilizing device, 11-Adaptive device, 111-Enhanced adsorption structure, 112-Gradual structure, 12-Negative pressure suction device, 121-Suction power source, 122-Suction chamber, 2-Injection device, 21-Injection assembly, 211-Injection needle, 212-Injection tube, 2121-Backflow judgment tube, 2122-Injection filling tube, 2123-Fixed tube, 2124-Feeding chamber, 2125-Injection chamber, 2126-Communication port, 213-Injection interface, 214-Injection tube seal, 215 -Reinforced tube, 2151-Circular groove C, 2152-Groove D, 216-Flexible tube, 217-Injection control device, 2171-Injection piston, 2172-Piston push rod, 2173-Feeding device, 2174-Force grip, 22-Injection control mechanism, 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 fixing piece, 22132-Bendable section, 22 133-bending control part, 221331-bending control tube through hole, 22134-bending control handle, 221341-bending control seat, 221342-bending control operating part, 221343-bending control part, 22135-bending control tube seal, 2214-outer tube seal, 222-needle handle, 2221-needle seat, 2222-needle stroke control mechanism, 22221-stroke control part, 22222-stroke control operating part, 22223-stroke pointer, 22224-push button, 222 25-stroke controller, 22226-stroke controller fixing part, 22227-stroke guide rail, 2223-needle outlet limit control mechanism, 22231-limit control part, 22232-limit control operating part, 22233-limit pointer, 2224-holding part, 22241-groove, 22242-through hole, 23-filtering structure, 24-monitoring mechanism, 241-visible window, 242 is the observation component, 3-guide device, 31-injection needle guide hole, 32-adsorption hole, 4-filler. DETAILED DESCRIPTION

[0070] The present invention provides a myocardial filling system, comprising a stabilizing device 1, an injection device 2, a guiding device 3 and a filler 4; wherein

[0071] The stabilization device 1 includes at least an adaptive device, which is fixedly arranged at the distal end of the myocardial filling system. The adaptive device has a morphologically adaptive structure. When the adaptive device is attached to the surface of the myocardial tissue, the relative position of the myocardial filling system on the myocardial tissue is defined.

[0072] The injection device 2 comprises at least an injection assembly 21 and an injection control mechanism 22. The injection assembly 21 comprises an injection needle 211 and an injection tube 212. The filler 4 is controllably injected into the myocardial tissue via the injection assembly 21.

[0073] The guide device 3 is fixedly arranged in the distal area of ​​the myocardial filling system and is located in the adaptive device. The guide device is provided with an injection needle guide hole 31 that forms a sliding fit with the injection needle 211, thereby realizing the positioning and needle removal functions of the injection needle 211 on the myocardial tissue.

[0074] The advantage of the above-mentioned injection needle guide hole design is that it can limit the needle withdrawal position of the injection needle, achieve accurate positioning of the injection point on the target tissue, avoid the high risk of needle bending or breakage, and with the help of the needle withdrawal stroke control mechanism mentioned later, the injection needle can be inserted into the target tissue easily and quickly, achieving the performance characteristics of convenient targeted needle insertion, easy withdrawal of the injection needle, and safe and reliable entire process.

[0075] In one embodiment, the stabilization device 1 includes a negative pressure suction device 12, which includes a suction power source 121 and a suction chamber 122. The suction power source 121 is located outside the myocardial filling system. An adsorption hole 32 is provided on the guide device 3. The adaptive device forms a gas connection with the adsorption hole 32, the suction chamber 122, and the suction power source 121 to realize the negative pressure suction function.

[0076] The advantage of the above-mentioned negative pressure suction device design is that, in the working state, the stabilizing device 1 and the target tissue form a negative pressure state, which fundamentally prevents the phenomenon of the filler 4 being squeezed out of the injection area due to poor diffusion in the tissue or accompanied by the self-tension or movement force of the target tissue during the injection process, that is, the filler leaking back from the human tissue in this area, ensuring that the injection volume entering the target tissue is precisely controlled, so that the tissue filling degree is maximized. Therefore, the injection of the present invention is safe and controllable, and the filling effect is excellent.

[0077] In one embodiment, the injection control mechanism 22 includes at least an outer tube assembly 221 and a needle removal handle 222. The outer tube assembly includes 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 limitedly connected or fixedly connected to the bending control mechanism 2213. The injection assembly 21 passes through the outer tube assembly 221, and the needle removal handle 222 is arranged on the injection tube 211.

[0078] In a specific embodiment, the distal region of the injection tube 212 is provided with an adaptive bending structure, and the bending control mechanism 2213 includes a distal fixing member 22131, a bendable section 22132, a bending control member 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 partially or completely covers the adaptive bending structure in the axial direction; the distal end of the bending control member 22133 is connected to the distal end of the injection tube 212 through the distal end. The end fixing part 22131 is fixedly connected to the outer tube 2211; the bending control handle 22134 includes a bending control operating part 221342, a bending control part 221343 and a bending control seat 221341, and the proximal end of the bending control part 22133 is fixedly connected to the bending control part 221343; by operating the bending control operating part 221342, the bending control part 221343 drives the bending control part 22133 to move axially, thereby realizing the bending of the distal part of the myocardial filling system.

[0079] In a preferred embodiment, the bending control member 22133 is a bending control wire axially laid inside the wall of the outer tube 2211 or outside the outer tube 2211 , or the bending control member 22133 is a bending control tube sleeved inside the outer tube 2211 .

[0080] In a preferred embodiment, the bending control member 22133 is a bending control tube sleeved inside the outer tube 2211, and the outer tube 2211 and the bending control tube are coaxially slidably matched. The bendable section 22132 of the outer tube 2211 is a plurality of hollow structures A, and the hollow structure A is a narrow strip-shaped through groove. 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 bending control tube is provided with a plurality of hollow structures B, and the hollow structure B is a narrow strip-shaped through groove. The plurality of hollow structures B are parallel to each other and surround the bending control tube. The plurality of hollow structures A and the plurality of hollow structures B partially or completely overlap in the axial direction, but are separated on both sides of the tube wall.

[0081] When the bending control operating part 221342 drives the bending control member 221343 to move axially toward the distal end, the bending control member 22133 simultaneously moves axially toward the distal end, and the hollow structure B in the distal region of the bending control member 22133 gradually opens, causing the bending control member 22133 to bend in one direction to a certain angle. At the same time, the hollow structure A in the distal region of the outer tube 2211 gradually closes, causing the outer tube 211 to bend in the direction to the same angle. The bending direction of the distal part of the myocardial filling system is as follows: Figure 7a As shown; when the bending control operating part 221342 is operated to drive the bending control member 221343 to move axially toward the proximal end, the bending control member 22133 simultaneously moves axially toward the proximal end, and the hollow structure B in the distal region of the bending control member 22133 gradually closes, causing the bending control member 22133 to bend in another direction to a certain angle. At the same time, the hollow structure A in the distal region of the outer tube 2211 gradually opens, causing the outer tube 211 to bend in that direction to the same angle. The bending direction of the distal part of the myocardial filling system is as shown in FIG. Figure 7b shown.

[0082] The advantage of the above-mentioned bending control mechanism 2213 design is that the bending adjustment structure can accurately control the angle change of the bendable section 22132 area, and can adjust the angle of the bendable section 22132 according to actual needs. It is suitable for minimally invasive surgery or interventional surgery, and is particularly suitable for myocardial injection filling surgery that requires up to 20 point selection and target positioning and requires precise control of injection depth and injection volume. The operating channel used in this operation, whether it is a minimally invasive approach through a small chest incision to reach the outer surface of the heart (epicardium) under laparoscopy, or an interventional approach through the femoral artery along the arterial system to reach the inner surface of the heart (endocardium of the left ventricular cavity), can realize multi-directional and multi-operation space injection of the myocardial filling system. Therefore, this design has a reliable structure, safe operation, fast and controllable operation.

[0083] In a specific embodiment, the outside of the bendable section 22132 of the outer tube 2211 is sealed with an outer tube seal 2214 that bends synchronously with the bendable section 22132. The distal region of the outer tube seal 2214 is tightly connected to the adaptive device 11, and its proximal region is tightly connected to the distal part of the outer tube handle 2212. A bending control tube seal 22135 is fixedly connected to the outer tube handle 2212, and the bending control tube 22133 passes through the bending control tube seal 22135 and the two form a sliding seal fit; an injection tube seal 214 is provided on the bending control component 221343, and the injection tube 212 passes through the injection tube seal 214 and the two form a sliding seal fit.

[0084] The arrangement of the above-mentioned outer tube seal 2214, bend control tube seal 22135 and injection tube seal 214 effectively enhances the sealing of the system, improves the adsorption of the stabilization device on the target tissue, prevents the system from falling off during the injection process and causing safety accidents, and also prevents the sliding from being too tight due to poor fitting.

[0085] Furthermore, the outer tube seal 2214, the bend control tube seal 22135, the injection tube seal 214, the injection tube 212 and the outer tube 2211 form a three-dimensional space surrounded by a suction cavity 122, and the adsorption hole 32, the suction cavity 122 and the outer tube handle through hole 22121 set in the outer tube handle 2212 form a suction channel.

[0086] Further preferably, a bend control tube through hole 221331 is provided on the bend control tube 22133 located between the distal end of the bend control tube seal 22135 and the proximal end of the outer tube 2211, and the suction channel includes the bend control tube through hole 221331, so that the outer tube handle through hole 22121 and the adsorption hole 32 are gas-connected via the bend control tube through hole 221331.

[0087] In a preferred embodiment, an interface 22122 is provided on the outer tube handle 2212 , and the interface 22122 realizes a detachable connection between the suction power source 121 and the outer tube handle 2212 .

[0088] In a preferred embodiment, the adsorption hole 32 in the guide device 3 accounts for the remaining area excluding the area occupied by the injection needle guide hole 31, which accounts for about two-thirds of the cross-sectional area of ​​the inner cavity of the guide device 3. The axial length of the suction cavity 122 is 50 to 1500 mm, and the space in the cross section of the suction cavity 122 is 0.1 to 20 mm. 2 The area of ​​the through hole 221331 of the control bend pipe is 3 to 30 mm 2 After repeated verification in in vitro tests and animal experiments, it can ensure that the stabilization device will not loosen from the target tissue surface when subjected to a large tensile force (such as 15N).

[0089] In one embodiment, Figure 4 As shown, the needle removal handle 222 includes a needle removal seat 2221, a needle removal stroke control mechanism 2222, and / or a needle removal limit control mechanism 2223. The needle removal seat 2221 is axially limitedly connected or fixedly connected to the outer tube handle 2212 or the bending control mechanism 2213. The needle removal stroke control mechanism 2222 controls the stroke of the injection needle 211 extending out of the guide device 3, and the needle removal limit control mechanism 2223 limits the maximum stroke of the injection needle 211 extending out of the guide device 3.

[0090] In the first embodiment, the needle removal handle 222 includes a needle removal seat 2221, a needle removal stroke control mechanism 2222 and a needle removal limit control mechanism 2223. The needle removal stroke control mechanism 2222 includes a stroke control member 22221 and a stroke control operating part 22222. The stroke control member 22221 is limitedly connected or fixedly connected to the injection tube 212. By operating the stroke control operating part 22222, the injection needle 211 is extended stepwise or continuously relative to the guide device 3, thereby realizing the stroke control of the injection needle 211 extending out of the guide device 3; the needle removal limit control mechanism 2223 includes a limit control member 22231 and a limit control operating part 22232. The limit control member 22231 is axially slidable relative to the needle removal seat 2221, so that the limit control member 22231 can abut against the stroke control member 22221. The needle removal limit control mechanism 2223 limits the maximum stroke of the injection needle 211 extending out of the guide device 3.

[0091] In another embodiment, the needle ejection handle 222 shown includes a needle ejection seat 2221, a needle ejection stroke control mechanism 2222 and a gripping portion 2224. The needle ejection seat 2221 and the outer tube handle 2212 are axially limited or fixedly connected. The needle ejection stroke control mechanism 2222 includes a push button 22224, a stroke controller 22225, a stroke controller fixing 22226 and a stroke guide rail 22227. The stroke controller 22225 is fixedly connected to the injection tube 212, and a groove 22241 is fixedly set in the distal area of ​​the gripping part 2224. The depth of the distal area of ​​the groove 22241 is deeper than that of the proximal area, and is the thickness of the travel guide 22227, but does not pass through the gripping part 2224. The travel guide 22227 is ratchet-shaped and fixedly set in the distal area of ​​the groove 22241. A through hole 22242 that passes through the gripping part is set in the proximal area of ​​the groove 22241. The push button 22224 is set in the groove 22241, and the stroke controller 22225 and the push button 22224 are fixedly connected by the stroke controller fixing part 22226. The push button part 22224 can slide on the groove 22241 and the stroke guide rail 22227. Operating the push button 22224 causes the injection needle 211 to step out relative to the guide device 3, thereby realizing the stroke control of the injection needle 211 extending out of the guide device 3.

[0092] The advantages of the above two stroke control designs are that they can control the depth of the injection needle according to clinical needs, can accurately control the needle withdrawal stroke of the injection needle, improve the injection accuracy, avoid excessive insertion causing the needle tip to penetrate the entire target tissue, reduce the risk during the injection process, and are easy to operate and safe and reliable for injection.

[0093] In a preferred embodiment, the outer tube handle 2212, the bending control handle 22134, and the needle removal handle 222 form an integrated large handle.

[0094] In a preferred embodiment, the bending control mechanism 2213 is provided with a bending control angle mark, or the needle handle 222 is provided with a needle out scale mark for easy observation by the operator, such as Figure 13 As shown, the needle withdrawal scale mark includes a scale line 22211, a stroke pointer 22223 and / or a limit pointer 22233. The scale line 22211 is located on the needle withdrawal seat 2221, the stroke pointer 22223 is fixedly set on the stroke control member 22221, and the limit pointer 22233 is fixedly set on the limit control member 22231. The limit pointer 22233, the needle withdrawal seat 2221, and the stroke pointer 22223 are coaxially arranged from far to near. The actual needle withdrawal length of the injection needle 211 is confirmed by judging the position of the stroke pointer 22223.

[0095] The advantage of the above-mentioned scale marking design is that the addition of marking scale lines on the needle outlet seat can clearly determine the specific positions of the travel pointer and the limit pointer. By judging the position of the pointer, the real-time position of the injection needle of the system can be directly determined, and the insertion depth of the injection needle can be accurately controlled, thereby further improving the insertion accuracy of the injection needle and avoiding excessive insertion that causes the needle tip of the injection needle to penetrate the entire target tissue, such as the myocardial wall.

[0096] In a specific embodiment, Figures 17a-17c As shown, the injection needle 211 has shape memory and is preferably pre-formed into a certain shape, such as a curved arc, using an elastic metal tube, so as to have both the first form and the second form. Figure 17a In the embodiment, the needle 211 has a first form, i.e., a straight state, which facilitates the injection needle 211 to be safely and smoothly ejected along the injection needle guide hole 31; operating the needle ejection handle 222 can cause the injection needle 211 to be extended from the injection needle guide hole 31, and the injection needle 211 is gradually expanded in a predetermined shape until it is completely ejected. Figures 17b-17c Finally, the second configuration, a curved arc shape, is formed. Due to the design of the aforementioned negative pressure suction device, regardless of whether the target tissue surface is flat or curved and uneven, such as the inner or outer surface of the heart, the target tissue can be attracted to the adaptive device and contact the distal surface of the guide device 3. Under this premise, the injection needle, which has been pre-formed into a curved arc shape, can easily achieve the function of injecting the target tissue. Of course, when in the second configuration, the cutting edge of the injection needle 211 should be facing away from the myocardial filling system, and the movement trajectory of the injection needle 211 should be circular to prevent the cutting edge from scraping the inner wall of the injection needle guide hole and affecting the smoothness of needle removal. The injection needle guide hole 31 in the guide device 3 can, to a certain extent, ensure that the second configuration of the injection needle 211 remains relatively stationary relative to the myocardial filling system. This ensures that the position of the injection needle, including the needle tip, within the target tissue remains unchanged throughout the subsequent injection process, ultimately achieving the injection of a specific amount or volume of filler into a predetermined location within the target tissue and achieving precise control of the injection depth.

[0097] In a preferred embodiment, the inner diameter ID of the injection needle 211 is between 0.05 and 0.4 mm, and the wall thickness is between 0.01 and 0.2 mm. When the injection needle 211 is in the second form, the bending radius R is ≤ 8 mm, and 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 does not exceed 0.1 mm.

[0098] This design, combining both the first and second configurations, also keeps the needle and target tissue relatively stationary, improving safety during injection and reducing the risk of the needle accidentally falling out during target tissue vibration, thus preventing filler leakage. The orientation of the needle's cutting edge helps push the filler within the target tissue away from the myocardial filling system, significantly improving filler delivery.

[0099] In a preferred embodiment, Figure 14 As shown, the syringe 212 is adaptively deformable. A reinforcement tube 215 is fixedly mounted between the proximal region of the syringe 212 and the injection port 213, and a flexible tube 216 is wrapped around the proximal region of the reinforcement tube 215. The advantages of the aforementioned reinforcement tube 215 and flexible tube 216 design are that the addition of the reinforcement tube 215 improves the bending resistance of the syringe 212 within the handle region and the exposed area of ​​the handle, preventing adaptive deformation of the syringe 212 during insertion. This allows the needle to move the same distance as the syringe moves distally, thus ensuring precise control of the needle withdrawal length and speed, further improving the safety of the myocardial injection system and enhancing precise control of the injection depth. Furthermore, it prevents the system from being rendered inoperable due to unexpected circumstances, such as being dropped or misplaced. The addition of the flexible tube 216 reduces the rigidity of the reinforcement tube 215 to a certain extent, preventing the syringe 212 from inevitably bending or breaking during operation, thereby enhancing the comfort, safety, and durability of the system.

[0100] Further preferably, the middle area of ​​the reinforcing tube 215 is provided with a plurality of circular grooves C, such as Figure 15 As shown, the circular groove C 2151 is a through hole that penetrates the reinforcing tube 215 and is distributed in the middle section of the reinforcing tube 215. The injection tube 212 is fixedly connected by means of glue or other connection methods by injecting glue through the through hole. A plurality of grooves D are provided in the proximal region of the reinforcing tube 215, as shown in FIG. Figure 16 As shown, the groove D2152 is a π-shaped groove that runs through the reinforcing tube 215 and is spirally distributed in the proximal area of ​​the reinforcing tube 215 to improve the bending resistance of the injection tube 212. The flexible tube 216 completely covers the groove D.

[0101] The design of the stabilizing device 1 and the adaptive device 11, particularly the compressible resilience of the adaptive device 11, enables successful injection of highly viscous injectables without increasing the diameter of the injection needle. This has the advantage of low or almost no leakage from human tissue, making it suitable for minimally invasive or interventional surgeries, particularly minimally invasive myocardial injection and filling procedures performed through a small chest incision under laparoscopy to reach the outer surface of the heart. This does not affect the size of the opening for such surgeries, thereby reducing surgical risks. In one embodiment, the adaptive device 11 has a corrugated structure, which includes one or more of the following: annular textures, arcuate textures, and striped textures:

[0102] (1) Figure 19 As shown, the annular texture is distributed in an annular shape along the circumferential direction of the stabilizing device, so that the stabilizing device 1 has compressible resilience in the axial direction. The advantage of this annular texture design is that after the stabilizing device 1 is adsorbed on the target tissue, it undergoes adaptive deformation and can rotate freely in the circumferential angle, thereby increasing the range of motion of the device. For myocardial injection filling surgery, even if the minimally invasive operation channel has relatively limited, it is possible to take advantage of the adaptive strain of the adaptive device to achieve multiple point selections and accurate targeting on the surface of the heart, and then combine it with the design of the aforementioned negative pressure suction device to ultimately ensure the smooth implementation of multiple needle insertions and subsequent injections of fillers. Of course, the annular texture can continuously adapt to the beating of the target tissue, so that the negative pressure state between the stabilizing device 1 and the target tissue is always maintained, so that the negative pressure suction device 12 can continue to effectively perform its intended function.

[0103] (2) Figure 20 As shown, when the wrinkled structure is an arc-shaped texture, the arc-shaped texture is distributed in a ring shape along the circumference of the stabilizing device 1 in the proximal region of the stabilizing device 1, so that the stabilizing device 1 has compressible resilience in the axial direction. The advantage of this arc-shaped texture design is that after the stabilizing device 1 is adsorbed on the target tissue, it undergoes adaptive deformation, but can only move in the direction defined by the arc-shaped texture. To a certain extent, it avoids the difficulty or inability of acupuncture due to the difference in the surface morphology of the target tissue at the acupuncture point, ensuring a smooth acupuncture process. The arc-shaped texture can continuously adapt to the vibration of the target tissue, facilitating the maintenance of a negative pressure state between the stabilizing device 1 and the target tissue, so that the negative pressure suction device 12 can continue to effectively perform its intended function.

[0104] (3) Figures 21a-21bAs shown, when the corrugated structure is a strip texture, the strip texture is distributed in the distal region of the stabilizer 1 along an inclined direction toward the distal end, so that the distal portion of the stabilizer 1 has a rebound elasticity that can be expanded. When the stabilizer 1 is in a natural, unconstrained state, the corrugated structure is fully expanded, and the maximum diameter can exceed 10mm. When the stabilizer 1 is in a compressed state, the strip texture can be stacked in a certain way. After compression, it can be reduced to a size that can smoothly enter and exit a lumen with a small inner diameter ID, so as to adapt to various access channels for the myocardial filling system to reach the myocardial surface, especially including the 5mm or 10mm puncture cannula lumen equipped for laparoscopic surgery. The advantage of this design is that the strip texture adaptively deforms as the target tissue beats, which can increase the contact area between the stabilizer 1 and the target tissue, improve the adsorption, and facilitate maintaining a negative pressure state between the stabilizer 1 and the target tissue.

[0105] In another embodiment, the adaptive device is directly made of a material having resilience, such as silicone.

[0106] In a preferred embodiment, Figure 22 As shown, the stabilizing device 1 is provided with an enhanced adsorption structure 111, which is convex in the waist area of ​​the stabilizing device 1 and converges inward toward the distal end. This design not only maximizes the volume enclosed by the stabilizing device 1, but also increases the volume of the target tissue adsorbed into the inner cavity of the stabilizing device 1, thereby significantly improving the adsorption efficiency, helping to maintain a negative pressure state between the stabilizing device 1 and the target tissue, and avoiding the warping of the distal edge of the stabilizing device due to flipping toward the proximal end, which affects the adsorption effect.

[0107] In another preferred embodiment, Figure 23 As shown, the stabilizing device 1 is provided with a gradient structure 112, which is at the waist of the stabilizing device 1 and gradually transitions from thick to thin toward the distal area, thereby increasing the strength of the stabilizing device 1 and preventing deformation during the adsorption process, affecting the adsorption effect, and even causing the stabilizing device 1 to collapse, resulting in failure of the negative pressure state. For this purpose, the wall thickness of the proximal area is preferably designed to be 1 to 1.5 mm, and the wall thickness of the distal end is 0.2 to 0.5 mm.

[0108] In one embodiment, a local raised structure is fixedly provided on the outer surface of the injection tube 212, which is designed as an integral part of the injection tube 212. The raised structure is distributed in a point-like or strip-like manner, so that the injection tube 212 and the outer tube 2211 can form a coaxial sliding fit. After the raised structure contacts the outer tube 2211, it can prevent the injection tube 212 from folding or deforming during the axial sliding process, resulting in a reduction in the needle removal accuracy of the injection needle 211, thereby playing the same role as the aforementioned reinforcing tube 215. Not only that, the raised structure also greatly reduces the contact area between the injection tube 211 and the outer tube 2211, significantly reduces friction resistance, and at the same time increases the space of the suction channel, greatly improving the adsorption efficiency.

[0109] In one embodiment, Figure 24 As shown, a filter structure 23 is fixedly provided at the distal end of the guide device 3. The filter structure 23 has one or more micropores, which allow gas to pass through the micropores but prevent liquid from passing through the micropores. When the system is in operation, the stabilization device 1 can still be adsorbed on the target tissue, and the adsorption force is basically the same as before the filter structure 23 is added. The advantage of the design of the filter structure 23 is that during the injection process, if the filler 4 leaks from the target tissue, the filler 4 can be blocked by the filter structure 23, preventing it from being sucked back into the suction chamber 122 under negative pressure and causing clogging of the suction channel. This facilitates multiple and multi-point injections of the system and fully ensures the reusability of the system. In addition, the filter structure 23 covers the guide device 3, increasing the contact area, preventing damage to the target tissue when attached to the guide device 3, and improving safety.

[0110] In one embodiment, Figure 25 As shown, a monitoring mechanism 24 is provided at the distal end of the myocardial filling system. The monitoring mechanism 24 is a visual window 241 extending through the walls of the outer tube 2211 and the bend control tube 22133, or the monitoring mechanism 24 comprises an observation component 242 made of a light-transmitting material. The observation component 242 comprises part or all of the injection tube 212, the outer tube 2211, the bend control tube 22133, the outer tube seal 2214, and / or the adaptive device 11. The advantage of the design of the monitoring mechanism 24 is that during the injection process, the needle position, the depth of the injection needle, and the position of the injection tube can be monitored in real time, enabling better judgment of the injection effect and the injection progress of the filling material, thereby improving safety.

[0111] In one embodiment, the injection assembly 21 also includes an injection control device 217, which includes an injection piston 2171, a piston push rod 2172, and a feeding device 2173. The injection piston 2171 is made of a polymer material with elasticity and shape recovery, and is fixedly arranged at the distal end of the piston push rod 2172. The injection piston 2171 can achieve sliding sealing cooperation 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, which can transmit force in the axial direction. Pushing the piston push rod 2171 can realize the axial movement of the injection piston 2171 in the injection tube 212.

[0112] In one embodiment, a detachable connection structure is provided between the feeding device 2173 and the injection assembly 21. Furthermore, the feeding device 2173 is provided at the proximal end of the injection tube 212 and is an adjustable device. When adding filler 4 to the injection tube 212, the feeding device 2173 is in the open state; when the myocardial filling system is in the injection working state, the feeding device 2173 is in the closed state. This design allows the operator to conveniently and quickly reload the injectable material 4 into the injection tube 212 during myocardial injection filling procedures with up to 20 selected points and targeted injections, thereby meeting the needs of multiple timely filling, loading and injection of the injectable material 4.

[0113] The present invention will be described in detail and specifically below through specific examples to provide a better understanding of the present invention, but the following examples do not limit the scope of the present invention.

[0114] Example 1

[0115] This embodiment provides a myocardial filling system (hereinafter referred to as "this system"), which is composed of a stabilizing device 1, an injection device 2, a guiding device 3 and a filler 4. Figure 1 As shown, the stabilization device 1 is fixedly mounted at the distal end of the injection device 2 and is adapted to adhere to the surface of the myocardial tissue. The stabilization device 1 is provided with an adaptive device 11, which enables adaptive deformation of the stabilization device 1, thereby achieving relative stationary movement of the stabilization device on the myocardial tissue. The stabilization device 1 also includes a negative pressure suction device 12, which comprises a suction power source 121 and a suction chamber 122. The suction power source 121 is located outside the system. The adaptive device 11 establishes gas communication with the suction chamber 122 and the suction power source 121 through the adsorption hole 32 provided in the guide device 3, thereby achieving the negative pressure suction function.

[0116] In this embodiment, Figure 1In the figure, the injection device 2 includes an injection component 21 and an injection control mechanism 22. The injection component 21 includes an injection needle 211, an injection tube 212, and an injection interface 213. The injection needle 211 is fixedly arranged at the distal end of the injection tube 212, and the injection interface 213 is fixedly arranged 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 connection, 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 ejected from the injection needle 211, completing the injection filling process of the filler 4 into the target tissue.

[0117] In this embodiment, Figure 2-5 In the embodiment, the injection control mechanism 22 includes an outer tube assembly 221 and a needle removal handle 222. The outer tube assembly 221 includes 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 2211, the outer tube handle 2212, and the bending control mechanism 2213 are axially limited or fixedly connected. The injection assembly 21 passes through the outer tube assembly 221. The needle removal handle 222 is arranged on the injection tube 212 and includes a needle removal seat 2221, a needle removal stroke control mechanism 2222, a needle removal limit control mechanism 2223, and a grip 2224. The needle removal seat 2221, the needle removal stroke control mechanism 2222, the needle removal limit control mechanism 2223, and the grip 2224 are axially limited or fixedly connected. Axial movement of the injection assembly 21 is achieved by operating the needle removal handle 222. The outer tube handle 2212, the bending control mechanism 2213, and the needle removal handle 222 form an integrated large handle.

[0118] In this embodiment, Figure 4 In the figure, the needle withdrawal stroke control mechanism 2222 includes a stroke control member 22221 and a stroke control operating part 22222. The stroke control member 22221 is limitedly connected or fixedly connected to the injection tube 212. The stroke control operating part 22222 is operated to make the injection needle 211 extend continuously or stepwise relative to the guide device 3, thereby realizing the stroke control of the injection needle 211 extending out of the guide device 3; the needle withdrawal limit control mechanism 2223 includes a limit control member 22231 and a limit control operating part 22232. The limit control member 22231 is axially slidable relative to the needle withdrawal seat 2221, so that the limit control member 22231 can abut against the stroke control member 22221. The needle withdrawal limit control mechanism 2223 limits the maximum stroke of the injection needle 211 extending out of the guide device 3.

[0119] In this embodiment, Figure 5In the figure, the distal region of the injection tube 212 is provided with an adaptive bending structure, and the bending control mechanism 2213 includes a distal fixing part 22131, a bendable section 22132, a bending control part 22133 and a bending control handle 22134. The bendable section 22132 is located in the distal region of the outer tube 2211, and the bendable section 22132 partially or completely covers the adaptive bending structure in the axial direction.

[0120] In this embodiment, Figures 6a-6c In the embodiment, the bending control member 22133 is a bending control tube, and the bendable section 22132 of the outer tube 2211 is a plurality of hollow structures A, such as Figure 6a As shown, the hollow structure A is a narrow strip-shaped through groove, and multiple 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 bendable section 22132 of the control bending tube is a plurality of hollow structures B, as shown in FIG. Figure 6b As shown, the hollow structure B is similarly a narrow strip-shaped through groove. Multiple hollow structures B are parallel to each other and surround the bending control tube. Multiple hollow structures A and multiple hollow structures B partially or completely overlap in the axial direction, but are separated on both sides of the tube wall and distributed in opposite directions, as shown in FIG. Figure 6c As shown, the bending control tube is fixedly connected to the distal end of the outer tube 2211 through a distal fixing member 22131. The bending control handle 22134 includes a bending control seat 221341, a bending control operating part 221342 and a bending control part 221343. The bending control part 221343 is fixedly connected to the proximal end of the bending control part 22133. By operating the bending control operating part 221342 to drive the axial movement of the bending control part 221343, the distal part of the myocardial filling system is bent in at least two directions.

[0121] Specific working status such as Figures 7a-7b As shown, when the bending control operating part 221342 drives the bending control member 221343 to move axially toward the distal end, the bending control member 22133 simultaneously moves axially toward the distal end, and the hollow structure B in the distal region of the bending control member 22133 gradually closes, causing the bending control member 22133 to bend in one direction to a certain angle. At the same time, the hollow structure A in the distal region of the outer tube 2211 gradually opens, causing the outer tube 211 to bend in the direction to the same angle. The bending direction of the distal part of the myocardial filling system is as shown in FIG. Figure 7a As shown; when the bending control operating part 221342 is operated to drive the bending control member 221343 to move axially toward the proximal end, the bending control member 22133 simultaneously moves axially toward the proximal end, and the hollow structure B in the distal region of the bending control member 22133 gradually opens, causing the bending control member 22133 to bend in another direction to a certain angle. At the same time, the hollow structure A in the distal region of the outer tube 2211 gradually closes, causing the outer tube 211 to bend in that direction to the same angle. The bending direction of the distal part of the myocardial filling system is as shown in FIG. Figure 7b shown.

[0122] In this embodiment, the outer diameter OD of the outer tube 2211 is ≤10 mm, the length L is 50-500 mm, and the adjustable bending radius R is ≤20 mm.

[0123] In this embodiment, Figure 8 and Figure 10 As shown, the external seal of the bendable section 22132 of the outer tube 2211 is coated with an outer tube seal 2214 that bends synchronously 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 thereof is tightly connected to the distal portion of the outer tube handle 2212; a bending control tube seal 22135 is fixedly arranged in the outer tube handle 2212, the bending control tube 22133 passes through the bending control tube seal 22135 and the two form a sliding seal fit; an injection tube seal 214 is fixedly connected in the bending control component 221343, the injection tube 212 passes through the injection tube seal 214 and the two form a sliding seal fit. The outer tube seal 2214, the bend control tube seal 22135, the injection tube seal 214, the injection tube 212 and the outer tube 2211 form a three-dimensional space enclosed by a suction chamber 122. An outer tube handle through hole 22121 is provided in the outer tube handle 2212. The outer tube handle through hole 22121, the adsorption hole 32 and the suction chamber 122 form a suction channel, and the external suction power source 121 realizes the negative pressure suction function.

[0124] In this embodiment, Figure 10 As shown, a bend control tube through hole 221331 is provided on the bend control tube 22133 located between the distal end of the bend control tube seal 22135 and the proximal end of the outer tube 2211, and the suction channel includes the bend control tube through hole 221331, so that the outer tube handle through hole 22121 and the adsorption hole 32 are gas-connected via the bend control tube through hole 221331.

[0125] In this embodiment, Figure 10 As shown, an interface 22122 is provided on the outer tube handle 2212 , and the interface 22122 realizes a detachable connection between the suction power source 121 and the outer tube handle 2212 .

[0126] In this embodiment, Figure 10-12 In the figure, the guide device 3 is fixedly arranged at the distal end of the outer tube 2211. An injection needle guide hole 31 and an adsorption hole 32 are provided in the guide device 3. The injection needle guide hole 31 acts on the directional movement of the injection needle 211. Operating the needle handle 222 can make the injection needle 211 extend from the injection needle guide hole 31, thereby realizing the needle insertion function into the target tissue.

[0127] In this embodiment, Figure 10The adsorption hole 32 in the guide device 3 accounts for the remaining area excluding the area occupied by the injection needle guide hole 31, which accounts for about two-thirds of the guide device 3. The axial length of the suction cavity 122 is 50 to 1500 mm, and the cross-sectional space of the suction cavity 122 is 0.1 to 3 mm. 2 The area of ​​the through hole 221331 of the control bend pipe is 3 to 30 mm 2 After repeated verification in in vitro tests and animal experiments, it can ensure that the stabilization device will not loosen from the target tissue surface when subjected to a large tensile force (such as 15N).

[0128] In this embodiment, Figure 13 In the figure, a bending control angle mark is provided on the bending control mechanism 2213, and a needle withdrawal scale mark is provided on the needle withdrawal handle 222 for the convenience of observation by the operator. The needle withdrawal scale mark includes a scale line 22211, a stroke pointer 22223 and / or a limit pointer 22233. The scale line 22211 is located on the needle withdrawal seat 2221, the stroke pointer 22223 is fixedly set on the stroke control member 22221, and the limit pointer 22233 is fixedly set on the limit control member 22231. The limit pointer 22233, the needle withdrawal seat 2221, and the stroke pointer 22223 are coaxially arranged from far to near. The actual needle withdrawal length of the injection needle 211 is confirmed by judging the position of the stroke pointer 22223.

[0129] In this embodiment, Figure 14 As shown, the injection tube 212 can be adaptively deformed. A reinforcement tube 215 is fixedly provided between the proximal region of the injection tube 212 and the injection interface 213, and a layer of flexible tube 216 is wrapped around the proximal region of the reinforcement tube 215. A plurality of circular grooves C are provided in the middle region of the reinforcement tube 215, as shown in FIG. Figure 15 As shown, the circular groove C 2151 is a through hole that penetrates the reinforcing tube 215 and is distributed in the middle section of the reinforcing tube 215. It is used to fix the injection tube 212 by injecting glue or gluing. A plurality of grooves D are provided in the proximal region of the reinforcing tube 215. Figure 16 As shown, the groove D 2152 is a π-shaped groove that penetrates the reinforcing tube 215 and is spirally distributed in the proximal area of ​​the reinforcing tube 215 to improve the bending resistance of the injection tube 212. The flexible tube 216 completely covers the groove D.

[0130] In this embodiment, Figure 9 As shown, the outer surface of the injection tube 212 is fixedly provided with a local protrusion structure, which is designed as an integral part of the injection tube 212. The protrusion structure is distributed in a point-like or strip-like manner, so as to facilitate the coaxial sliding fit between the injection tube 212 and the outer tube 2211.

[0131] Example 2

[0132] like Figures 17a-17cAs shown, this embodiment is based on the first embodiment. The difference between this embodiment and the first embodiment is that the injection needle 211 has shape memory and is pre-formed into a certain shape, such as a curved arc, using an elastic metal tube, thus having both the first form and the second form.

[0133] When the needle tip of the injection needle 211 is located in the injection needle guide hole 31, as shown in FIG. Figure 17a In the embodiment, the needle 211 has a first form, i.e., a straight state, which facilitates the injection needle 211 to be safely and smoothly ejected along the injection needle guide hole 31; operating the needle ejection handle 222 can cause the injection needle 211 to be extended from the injection needle guide hole 31, and the injection needle 211 is gradually expanded in a predetermined shape until it is completely ejected. Figures 17b-17c In the second form, a second form, i.e., a curved arc shape, is formed. With the help of the design of the aforementioned negative pressure suction device, the needle insertion function into the target tissue is easily achieved. When in the second form, the cutting edge of the injection needle 211 faces away from the myocardial filling system, and the movement trajectory of the injection needle 211 is in the shape of an arc. The injection needle guide hole 31 on the guide device 3 can ensure that the second form of the injection needle 211 remains relatively stationary relative to the myocardial filling system.

[0134] In this embodiment, the inner diameter ID of the injection needle 211 is 0.05-0.4 mm, and the wall thickness is 0.01-0.2 mm. When the injection needle 211 is in the second form, the bending radius R is ≤ 8 mm; Figure 18 In the embodiment, 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 does not exceed 0.1 mm.

[0135] Example 3:

[0136] like Figure 19-23 As shown, this embodiment is based on the first embodiment. The difference between this embodiment and the first embodiment is that the adaptive device 11 of the stabilizing device 1 is a corrugated structure.

[0137] In this embodiment, the wrinkle structure includes one or more of annular texture, arc texture, and strip texture. Figure 19 As shown, the annular texture is distributed in an annular shape on the stabilizing device 1 along the circumferential direction of the stabilizing device, so that the stabilizing device 1 has compressible resilience in the axial direction. Figure 20 As shown, when the wrinkle structure is an arc-shaped texture, the arc-shaped texture is distributed in a ring shape along the circumference of the stabilizing device 1 in the proximal region of the stabilizing device 1, so that the stabilizing device 1 has compressible resilience in the axial direction. Figures 21a-21bAs shown, when the corrugated structure is a strip texture, the strip texture is distributed in the distal region of the stabilizing device 1 along the inclination direction toward the distal end, so that the distal part of the stabilizing device 1 has a rebound elasticity that can be expanded. When the stabilizing device 1 is in a natural and unconstrained state, the corrugated structure is fully expanded, and the maximum diameter exceeds 10 mm. When the stabilizing device 1 is in a compressed state, the strip texture can be stacked in a certain way, and after compression, it can be reduced to a size that can smoothly enter and exit a lumen with a small inner diameter ID, so as to adapt to various access channels for the myocardial filling system to reach the myocardial surface, especially including the 5 mm or 10 mm puncture cannula lumen equipped for laparoscopic surgery.

[0138] In the second embodiment, if Figure 22 As shown, the stabilization device 1 is also provided with an enhanced adsorption structure 111. The enhanced adsorption structure 111 is convex in the waist area of ​​the adaptive device and converges inward toward the distal end, so that the volume enclosed by the adaptive device is maximized, the adsorption efficiency is improved, and a negative pressure state is maintained between the stabilization device 1 and the target tissue.

[0139] In the third embodiment, if Figure 23 As shown, the stabilization device 1 is also provided with a gradient structure 112, which is at the waist of the adaptive device and gradually transitions from thick to thin toward the distal area. The preferred design is that the proximal area wall thickness is 1 to 1.5 mm, and the distal wall thickness is 0.2 to 0.5 mm.

[0140] Example 4:

[0141] like Figure 24 As shown, this embodiment is based on the first embodiment. The difference between this embodiment and the first embodiment lies in that a filter structure 23 is fixedly installed at the distal end of the guide device 3. The stabilization device 1 is fixedly installed outside the filter structure 23 to prevent the filter structure 23 from falling off. The filter structure 23 has one or more micropores that allow gas to pass through the micropores but prevent liquid from passing through. When the myocardial filling system is in operation, the stabilization device 1 can still be adsorbed on the target tissue, and the adsorption force is basically the same as before the addition of the filter structure 23.

[0142] Embodiment 5:

[0143] like Figure 25 As shown, this embodiment is based on the first embodiment. The difference between this embodiment and the first embodiment is that a monitoring mechanism 24 is provided at the distal end of the myocardial filling system. The monitoring mechanism 24 is a visual window 241 penetrating the walls of the outer tube 2211 and the bend control tube 22133, or the monitoring mechanism 24 comprises an observation component 242 made of a light-transmitting material. The observation component 242 is part or all of the injection tube 212, the outer tube 2211, the bend control tube 22133, the outer tube seal 2214, and / or the adaptive device, and assists in determining the effectiveness of the needle insertion and the actual progress of the filling material injection.

[0144] Example 6:

[0145] like Figure 26 As shown, this embodiment is based on the first embodiment. The differences between this embodiment and the first embodiment are:

[0146] (1) In this embodiment, the injection tube 212 has a dual-cavity structure, one cavity is a feeding cavity 2124, and the other cavity is an injection cavity 2125, and a connecting port 2126 is provided at the front end of the injection tube 212, so that the feeding cavity 2124 and the injection cavity 2125 are fluidically connected.

[0147] (2) In this embodiment, an injection control device 217 is further included, which includes an injection piston 2171, a piston push rod 2172, and a feeding device 2173. The proximal end of the piston push rod 2172 is provided with a force-applying grip 2174, which can transmit force in the axial direction. The injection piston 2171 is fixedly arranged at the distal end of the piston push rod 2172, so that the injection piston 2171 moves axially in the injection cavity 2125. The injection piston 2171 and the injection cavity 2125 are in sliding sealing cooperation. The feeding device 2173 is arranged at the proximal end of the feeding cavity 2124 and is a commercially available three-way valve. When the filler 4 is added to the feeding cavity 2124, the feeding device 2173 is in an open state; when the myocardial filling system is in the injection working state, the feeding device 2173 is in a closed state.

[0148] The advantage of the above-mentioned dual-chamber structure design is that the axial movement of the injection piston 2171 driven by the pushing piston push rod 2172 can completely empty the filler 4 in the injection chamber 2125 during the injection process, greatly reducing the waste of the filler 5 in the injection chamber 2125. The addition of the feeding device 2172 can ensure the uninterrupted replenishment of the filler 4 during the actual injection process, increase the injection sustainability of the myocardial filling system, and improve safety.

[0149] Embodiment seven:

[0150] like Figures 27-30 As shown, this embodiment is based on the first embodiment. The difference between this embodiment and the first embodiment is that the injection tube 212 in this embodiment is a double-lumen structure. Figure 28In the embodiment, the double-cavity structure is composed of two layers of tubes, one layer of tube is the withdrawal judgment tube 2121, and the other layer of tube is the injection filling tube 2122. The distal area of ​​the double-cavity structure is wrapped with a fixed tube 2123 of the same material. The contact parts of the withdrawal judgment tube 2121, the injection filling tube 2122 and the fixed tube 2123 are connected together by hot melting to prevent the gap between the tubes from causing leakage of the filler 4 or liquid during the injection process. The injection needle 211 is fixedly set at the distal end of the injection tube 212, and the proximal end of the injection needle 211 is fixedly set at the distal end of the injection tube 212. There is no contact between the withdrawal judgment tube 2121 and the injection filling tube 2122, leaving a certain gap. An interface 213 is connected to the proximal end of the withdrawal judgment tube 2121 and the injection filling tube 2122. The injection needle 211, the injection tube 212, and the injection interface 213 can form a fluid connection. During the injection process, when the injection needle 211 is inserted into the target tissue, the withdrawal judgment tube 2121 can be used for a withdrawal test first. After confirming safety, the injection filling tube 2122 can be used to inject the filler 4.

[0151] The advantage of the above-mentioned two-layer tube combination design is that during the injection process, the withdrawal judgment tube can be used first for withdrawal judgment to confirm whether the current position of the injection needle meets the requirements for injection, thereby avoiding the injection needle piercing the target tissue, reducing the risk of injection penetration, and improving the safety of the system. Subsequently, the injection filling tube can be used for injection to improve the injection efficiency of the system.

[0152] In another embodiment, Figure 28 In the middle, the withdrawal judgment tube 2121 and the injection filling tube 2122 can both undergo adaptive deformation. A reinforcement tube 215 is fixedly provided at the proximal region of the withdrawal judgment tube 2121 and the injection filling tube 2122 to the interface 213. The middle region of the reinforcement tube 215 is provided with a plurality of circular grooves C, such as Figure 29 As shown, the circular groove C 2151 is a through hole that penetrates the reinforcing tube 215 and is distributed in the middle area of ​​the reinforcing tube 215 for fixedly connecting the injection tube 212; the proximal area of ​​the reinforcing tube 215 is provided with a plurality of grooves D, such as Figure 30 As shown, groove D 2152 is a π-shaped groove that runs through the reinforcing tube 215 and is spirally distributed in the proximal area of ​​the reinforcing tube 215. It is used to improve the bending resistance of the injection tube 212, and a layer of flexible tube 216 is wrapped around the proximal area of ​​the reinforcing tube 215 to completely cover the groove D.

[0153] Embodiment 8:

[0154] like Figures 31-32 As shown, this embodiment is based on the first embodiment. The differences between this embodiment and the first embodiment are: (1) the bending control member 22133 is a bending control wire axially laid in the wall of the outer tube 2211; (2) the suction chamber 122 is composed of a separate tube; (3) the bending control handle 22134 and the outer tube handle 2212 are not arranged axially.

[0155] In this embodiment, Figure 31 As shown, the bending control handle 22134 includes a bending control seat 221341, a bending control operating part 221342 and a bending control part 221343. The bending control part 221343 is fixedly connected to the proximal end of the bending control part 22133. The injection component 21 passes through the outer tube component 221. The bending control operating part 221342 is operated to drive the bending control part 221343 to move, and then drive the bending control part 22133 to move, thereby realizing the bending of the distal part of the myocardial filling system.

[0156] In this embodiment, Figure 32 As shown, the suction chamber 122 is composed of a separate tube and is arranged in a cavity between the outer tube 2211 and the injection tube 212. The distal end of the suction chamber 122 is flush with the distal end of the outer tube 2211, and the proximal end of the suction chamber 122 is fixedly arranged on the outer tube handle 2212. An outer tube handle through hole 22121 is provided in the outer tube handle 2212. The outer tube handle through hole 22121, the suction chamber 122 and the adsorption hole 32 form a suction channel. An interface 22122 is provided on the outer tube handle 2212, and the interface 22122 realizes the detachable connection between the suction power source 121 and the outer tube handle 2212.

[0157] The advantage of the design of the suction chamber 122 of a separate tube is that the suction chamber 122 is composed of a fixed tube, and the size of the tube cavity will not change with the change of the cavity volume between the outer tube and the injection tube, which can maintain the stability of the suction efficiency. At the same time, the design of the tube can reduce the gap caused by the connection between the various connecting parts, thereby enhancing the adsorption efficiency of the stabilizing device.

[0158] Embodiment 9:

[0159] like Figure 33 As shown, this embodiment is based on embodiment one, and the difference between this embodiment and embodiment one is that: the needle ejection handle 222 shown includes a needle ejection seat 2221, a needle ejection stroke control mechanism 2222 and a gripping portion 2224, the needle ejection seat 2221 and the outer tube handle 2212 are axially limited or fixedly connected, and the needle ejection stroke control mechanism 2222 includes a push button 22224, a stroke controller 22225, a stroke controller fixing 22226 and a stroke guide rail 22227.

[0160] In this embodiment, the stroke controller 22225 is fixedly connected to the injection tube 212, and a groove 22241 is fixedly set in the distal area of ​​the gripping portion 2224. The depth of the distal area of ​​the groove 22241 is deeper than that of the proximal area, and is the thickness of the travel guide 22227, but does not pass through the gripping portion 2224. The travel guide 22227 is ratchet-shaped and fixedly set in the distal area of ​​the groove 22241. A through hole 22242 that passes through the gripping portion is set in the proximal area of ​​the groove 22241. The push button 22224 is set in the groove 22241, and the stroke controller 22225 and the push button 22224 are fixedly connected by the stroke controller fixing member 22226. The push button member 22224 can slide on the groove 22241 and the stroke guide 22227. Operating the push button 22224 causes the injection needle 211 to step out relative to the guide device 3, thereby realizing the stroke control of the injection needle 211 extending out of the guide device 3.

[0161] While the specific embodiments of the present invention have been described in detail above, these are merely exemplary and the present invention is not limited thereto. For those skilled in the art, any equivalent modifications and substitutions to the present invention are also within the scope of the present invention. Therefore, any equivalent changes and modifications made without departing from the spirit and scope of the present invention are intended to be encompassed within the scope of the present invention.

Claims

1. A myocardial filling system, characterized in that: It comprises a stabilizing device (1), an injection device (2), a guiding device (3) and a filler (4); wherein The stabilizing device (1) comprises at least an adaptive device, which is fixedly arranged at the distal end of the myocardial filling system, and has a morphologically adaptive structure. When the adaptive device is attached to the surface of the 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), wherein the injection assembly (21) comprises an injection needle (211), an injection tube (212), and an injection control device (217), and the filler (4) is controllably injected into the myocardial tissue via the injection assembly (21); The guide device (3) is fixedly arranged in the distal region of the myocardial filling system and is located in the adaptive device. The guide device is provided with an injection needle guide hole (31) that forms a sliding fit with the injection needle (211), thereby realizing the positioning and needle removal functions of the injection needle (211) on the myocardial tissue; The injection needle (211) has two forms. When the needle tip of the injection needle (211) is located in the injection needle guide hole, it has a first straight form. After the injection needle (211) extends out of the injection needle guide hole, it has a second curved form. The injection needle guide hole (31) on the guide device (3) ensures that the second form of the injection needle remains relatively stationary relative to the myocardial filling system. The injection device (2) comprises an injection control mechanism (22), the injection control mechanism (22) comprises an outer tube assembly (221) and a needle removal 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 injection assembly (21) passes through the outer tube assembly (221), and the needle removal handle (222) is arranged on the injection tube (211); 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 member (22131), a bendable section (22132), a bending control member (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) partially or completely covers the adaptive bending structure in the axial direction; the distal end of the bending control member (22133) is fixedly connected to the outer tube (2211) via the distal fixing member (22131); the bending control handle (22134) comprises a bending control operating portion (221342), a bending control member (221343) and a bending control seat (221341), wherein the proximal end of the bending control member (22133) is connected to the bending control member (221343); by operating the bending control operating portion (221342), the bending control member (221343) drives the bending control member (22133) to move axially, thereby realizing bending of the distal end portion of the myocardial filling system; the bending control member (22133) is a bending control wire axially laid inside the wall of the outer tube (2211) or outside the outer tube (2211), or the bending control member (22133) is a bending control tube sleeved inside the outer tube (2211); The bending control member (22133) is a bending control tube sleeved inside the outer tube (2211); the outer tube (2211) and the bending control tube are coaxially slidably matched; 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, the plurality of hollow structures A are parallel to each other and surround the outer tube (2211); inside the bendable section (22132) of the outer tube (2211), the bending control tube is provided with a plurality of hollow structures B, the hollow structures B are narrow strip-shaped through grooves, the plurality of hollow structures B are parallel to each other and surround the bending control tube, the plurality of hollow structures A and the plurality of hollow structures B partially or completely overlap in the axial direction, but are separated on both sides of the tube wall.

2. The myocardial filling system according to claim 1, characterized in that: The stabilizing device (1) includes a negative pressure suction device (12), and the negative pressure suction device (12) includes a suction power source (121) and a suction chamber (122). The suction power source (121) is located outside the myocardial filling system. An adsorption hole (32) is provided on the guide device (3). The adaptive device forms a gas connection with the adsorption hole (32), the suction chamber (122), and the suction power source (121), thereby realizing a negative pressure suction function.

3. The myocardial filling system according to claim 1, characterized in that: The adaptive device (11) of the stabilizing device (1) is a corrugated structure, and the corrugated structure includes one or more of annular texture, arcuate texture, and strip texture; wherein the annular texture and / or arcuate texture are distributed in an annular shape on the stabilizing device (1) along the circumferential direction of the stabilizing device, so that the stabilizing device (1) has compressible resilience in the axial direction; the strip texture is distributed in the distal region of the stabilizing device (1) along the inclination direction toward the distal end, so that the distal part of the stabilizing device (1) has resilience that can be expanded in the radial direction; or the adaptive device is directly made of a material with resilience.

4. The myocardial filling system according to claim 2, characterized in that: The outer portion of the bendable section (22132) of the outer tube (2211) is sealed with an outer tube seal (2214) that bends synchronously with the bendable section (22132); a bend control tube seal (22135) is fixedly connected to the outer tube handle (2212); the bend control tube (22133) passes through the bend control tube seal (22135) and the two form a sliding seal fit; an injection tube seal (214) is provided on the bend control member (221343); the injection tube seal (214) is provided on the injection tube seal (214). The tube (212) passes through the injection tube seal (214) and the two form a sliding seal fit; the outer tube seal (2214), the bend control tube seal (22135) and the injection tube seal (214), together with the three-dimensional space enclosed by the injection tube (212) and the outer tube (2211) form the suction cavity (122); the adsorption hole (32), the suction cavity (122) and the outer tube handle through hole (22121) provided in the outer tube handle (2212) form a suction channel.

5. The myocardial filling system according to claim 4, characterized in that: A bend control tube through hole (221331) is provided on the bend control tube (22133) located between the distal end of the bend control tube seal (22135) and the proximal end of the outer tube (2211), and the suction channel includes the bend control tube through hole (221331), so that the outer tube handle through hole (22121) and the adsorption hole (32) are in gas communication via the bend control tube through hole (221331).

6. The myocardial filling system according to claim 1, characterized in that: The outer surface of the injection tube (212) is fixedly provided with a local protruding structure, which is designed as an integral part of the injection tube (212). The protruding structure is distributed in a dotted or striped manner, facilitating a coaxial sliding fit between the injection tube (212) and the outer tube (2211).

7. The myocardial filling system according to claim 1, characterized in that: The needle ejection handle (222) comprises a needle ejection seat (2221), a needle ejection stroke control mechanism (2222) and / or a needle ejection limit control mechanism (2223); wherein the needle ejection seat (2221) is axially limit-connected or fixedly connected to the outer tube handle (2212) or the bending control mechanism (2213); the needle ejection stroke control mechanism (2222) controls the stroke of the injection needle (211) extending out of the guide device (3); and the needle ejection limit control mechanism (2223) limits the maximum stroke of the injection needle (211) extending out of the guide device (3).

8. The myocardial filling system according to claim 7, characterized in that: The needle-extraction stroke control mechanism (2222) comprises a stroke control member (22221) and a stroke control operating portion (22222); the stroke control member (22221) is limit-connected or fixedly connected to the injection tube (212); the stroke control operating portion (22222) is operated so that the injection needle (211) is extended stepwise or continuously relative to the guide device (3), thereby achieving stroke control of the injection needle (211) extending from the guide device (3); the needle-extraction limit control mechanism (2223) comprises a limit control member (22231) and a limit control operating portion (22232); the limit control member (22231) is axially slidable relative to the needle-extraction seat (2221), so that the limit control member (22231) can abut against the stroke control member (22221); and the needle-extraction limit control mechanism (2223) limits the maximum stroke of the injection needle (211) extending from the guide device (3).

9. The myocardial filling system according to claim 8, characterized in that: The bending control mechanism (2213) is provided with a bending control angle mark, or the needle ejection handle (222) is provided with a needle ejection scale mark for easy observation by the operator, the needle ejection scale mark includes a scale line (22211), a travel pointer (22223) and / or a limit pointer (22233), the scale line (22211) is located on the needle ejection seat (2221), the travel pointer (22223) is fixedly provided on the travel control member (22221), and the limit pointer (22233) is fixedly provided on the limit control member (22231).

10. The myocardial filling system according to claim 1, characterized in that: A filter structure (23) is fixedly provided at the far end of the guide device (3), and the filter structure (23) has one or more micropores, so that gas can pass through the micropores but liquid cannot pass through the micropores.

11. The myocardial filling system according to claim 4, characterized in that: A monitoring mechanism (24) is provided in the distal region of the myocardial filling system. The monitoring mechanism (24) is a visual window (241) penetrating the tube wall of the outer tube (2211) and the bend control tube (22133), or the monitoring mechanism (24) is an observation component (242) made of a light-transmitting material. The observation component (242) is part or all of the injection tube (212), the outer tube (2211), the bend control tube (22133), the outer tube seal (2214) and / or the adaptive device (11).

Images