WO2022052797A1

WO2022052797A1 - Myocardial filling system

Info

Publication number: WO2022052797A1
Application number: PCT/CN2021/114063
Authority: WO
Inventors: 李彪; 陈琦; 陈超; 吕世文
Original assignee: 宁波迪创医疗科技有限公司
Priority date: 2020-09-11
Filing date: 2021-08-23
Publication date: 2022-03-17
Also published as: CN114159646A

Abstract

Disclosed is a myocardial filling system, comprising a stabilizing device (1), an injection device (2), a guide device (3) and a filler (4); the injection device (2) comprises an injection assembly (21), an outer tube assembly (221), and a needle ejection handle (222); an injection needle (211), an injection tube (212) and an injection port (213) of the injection assembly (2) are in fluid communication, so that the filler (4) enters from the injection port (213) and is ejected from the injection needle (211); the guide device (3) is internally provided with an injection needle guide hole (31) and an adsorption hole (32); the needle ejection handle (222) is operated so that the injection needle (211) protrudes from the injection needle guide hole (31), so as to achieve the function of puncturing target tissue; the stabilizing device (1) further comprises a negative pressure suction device (12), the negative pressure suction device (12) comprises a suction power source (121) and a suction cavity (122); the suction power source (121) is located outside of the myocardial filling system; the adsorption hole (32) and the suction power source (121) form gas communication by means of the suction cavity (122) so as to achieve negative pressure suction; and the stabilizing device (1) is provided with an adaptive device (11), so that the stabilizing device (1) can be adaptively deformed, helping to form negative pressure between the stabilizing device (1) and the target tissue. The system is convenient for targeted needle injection, has controllable injection depth, enables safe and reliable injection, and has a good filling effect.

Description

a myocardial filling system

This application claims the priority of the Chinese invention patent application "A myocardial filling system" with application number 202010956485.7 filed in China on September 11, 2020, the entire contents of which are incorporated into this application by reference.

technical field

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

Background technique

In medical fields such as minimally invasive surgery for tissue injection and filling, a specific amount or volume of injection (including filler) is injected into the target area or specific location (including injection) of the tissue to be treated or repaired using a suitable injection device or filling system. depth) is the key to treatment. Tissues suitable for injection and filling are mainly divided into two categories. The first category is facial or external tissue mostly for modification or cosmetic purposes, such as cheeks, forehead, nose, chest, buttocks, etc. The second category is the emerging of recent years. Internal tissues or organs for the purpose of disease treatment or repair, such as cardiac myocardium wall, blood vessel wall, etc., the above-mentioned tissues have certain elasticity, but most of them are relatively dense structures. The characteristics of high viscosity, if the traditional syringe is used to inject such injections, including commercialized hyaluronic acid gels and alginic acid-based hydrogels with clinical application value, it will lead to: 1) due to the injection High viscosity, it is necessary to choose a thicker (such as OD≥0.5mm) injection needle, so that the injection can be easily pushed out from the injection tube through the injection needle, but the syringe with the thicker injection needle is pierced into the tissue When the needle is removed, the trauma is relatively large, 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. It is also easy to lead to safety issues such as wound infection or tissue adhesion to the tissues or organs that it may come into contact with, while thinner injection needles have many disadvantages, including: (1) When the injection needle is withdrawn or inserted into the target tissue , prone to high risk of needle bending or even needle breakage; ② The inner cavity of the injection needle for the injection to flow out is too small, making it difficult for the injection to be pushed from the injection tube, while the traditional syringe uses a piston and a piston rod to push the simple and easy It is difficult for the type design to meet this stringent requirement; ③ In order to achieve the effectiveness of the injection filling operation, the amount of the injection material needs to reach a certain value, usually several milliliters to several hundred milliliters, which not only requires multiple selections on the surface of the target tissue Spotting and targeting, and a specific volume of controlled injections for each target, in particular, for myocardium filling surgery, which requires up to 20 spotting and targeting, this procedure is preferred The operating channels include: a minimally invasive approach to the outer surface of the heart (epicardium) through a small incision in the chest, and an intervention to reach the inner surface of the heart (endocardium of the left ventricular cavity) through the femoral artery approach along the arterial system However, the heart is a complex three-dimensional structure, and its inner and outer surfaces are curved and uneven, and the above-mentioned minimally invasive operation channels have relative limitations, making multiple point selection and accurate targeting very challenging. Traditional syringes can no longer be achieved. In addition, up to 20 injections require the operator to conveniently and quickly refill the injection into the injection tube. Traditional syringes use the method of pulling back the plunger to inhale the injection from the injection needle into the injection tube. , it is bound to be time-consuming and laborious; 2) The high viscosity of the injection will inevitably lead to poor diffusion. When the target area is muscle tissue, the injection difficulty will be greatly increased. At the same time, during the injection process, the tissue Self-tension will force the injection material to reversely extrude out of the tissue along the outer wall of the injection needle, resulting in a large amount of injection material leakage, so the controllable injection of the injection volume cannot be guaranteed; 3) When performing myocardial injection filling, the target The area is the wall of the heart muscle, which is the device that keeps beating Guan, 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, which greatly increases the risk of the injection being squeezed out to the surface of the heart during the injection process, causing leakage. Of course , With the continuous beating of the heart, during the process of injecting the injection into the myocardial tissue, the position of the needle tip of the injection needle in the myocardial tissue is easily changed, resulting in the inability to accurately and effectively control the injection depth of the injection, which in turn affects The effectiveness of the injection filling procedure, and what is more, the injection needle may directly penetrate the entire heart wall, causing the injection to be injected unexpectedly into the natural cavity of the heart such as the atrium/ventricle, which eventually causes the injection to flow into and block the body. Safety accidents such as ischemic stroke caused by small blood vessels in the brain or ischemic necrosis caused by blockage of blood vessels in the limbs The smooth progress of the operation leads to prolonged surgery, which brings risks to the life safety of the target population or patients.

In order to achieve different technical purposes, those skilled in the art have made certain improvements to traditional syringes, such as a disposable syringe disclosed in patent CN200780034572, which has a needle retracted into the plunger after use, and when the needle is used When retracted, the syringe is sealed to prevent any liquid still remaining in the needle or needle from leaking out of the syringe. Its pierceable seal on the front of the plunger is self-sealing to prevent any fluid from leaking from the front of the syringe, and the distal end of the plunger seals against the back of the barrel of the syringe to prevent leakage from the back . The technical purposes of this design are: first, to prevent medical personnel from being stabbed when injecting dangerous goods; second, to prevent dangerous materials from leaking out of 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, because the leakage of the injection material in the tissue cannot be prevented, the leakage material will enter the area, causing secondary pollution; second, the sealing The seal is set inside the main body of the syringe, and there is a dead space between the seal and the needle holder. When the viscosity of the injection is large, the seal will bear greater resistance when it is pushed with the plunger, and at the same time, it will cause a dead space. The volume increases; third, the syringe is not suitable for minimally invasive surgery or interventional surgery, one cannot adapt to the curved passage of the human body, and second, it cannot be injected multiple times. , which will cause damage to the passage of the human body; fourth, the syringe cannot accurately determine the actual position of the injection needle, and it can only rely on the operator to control the pushing distance during the pushing process; fifth, the syringe has no depth limit structure, because The injection needle is a straight needle, which may cause uncertainty in the depth of the needle and increase the risk; sixth, the syringe is only suitable for one-time use and cannot complete continuous injections.

Therefore, the prior art has problems such as leakage of the injection material, inability to precisely control the injection volume and injection depth, and insufficient operation space.

SUMMARY OF THE INVENTION

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, which is used to assist the injection of injections with higher viscosity in different spaces, so as to solve the problem of the injection of injections in the prior art. Leakage, uncontrollable injection volume and injection depth, inaccurate needle depth, and insufficient operating space.

The technical purpose of the present invention is achieved through the following technical solutions:

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

The stabilization device at least includes an adaptive device, the adaptive device is fixedly arranged at the distal end of the myocardial filling system, and the adaptive device has a morphological adaptive structure, when the adaptive device is attached to the surface of the myocardial tissue When , the relative position of the myocardial filling system on the myocardial tissue is defined;

The injection device includes at least an injection assembly, the injection assembly includes an injection needle, an injection tube and an injection control device, and the filler can be injected into the myocardial tissue in a controlled manner through the injection assembly;

The guide device is fixedly arranged in the distal region of the myocardial filling system and is located in the adaptive device, and the guide device is provided with an injection needle guide hole that forms a sliding fit with the injection needle, so as to realize the The positioning of the injection needle on the myocardial tissue and the function of needle ejection.

Preferably, the stabilization device includes a negative pressure suction device, the negative pressure suction device includes a suction power source and a suction cavity, the suction power source is located outside the myocardial filling system, and the guide device An adsorption hole is arranged on the upper part, and the self-adaptive device is in gas communication with the adsorption hole, the suction cavity and the suction power source, so as to realize the negative pressure suction function.

Preferably, the injection device includes the injection control mechanism, the injection control mechanism includes an outer tube assembly and a needle exit handle, the outer tube assembly includes an outer tube, an outer tube handle and a bending control mechanism, the outer tube handle It is fixedly arranged at the proximal end of the outer tube, the injection assembly penetrates the outer tube assembly, and the needle out handle is arranged on the injection tube.

Preferably, the injection needle has two forms. When the needle tip of the injection needle is located in the injection needle guide hole, it has a linear first form. After the injection needle protrudes out of the injection needle guide hole , has a second shape of a curved arc; the injection needle guide hole on the guide device ensures that the second shape of the injection needle remains relatively stationary relative to the myocardial filling system.

Preferably, the adaptive device of the stabilization device is a corrugated structure, and the corrugated structure includes one or more of annular textures, arc textures, and strip textures; wherein, the annular texture and/or arc texture The shaped texture is distributed on the stabilizing device annularly along the circumferential direction of the stabilizing device, so that the stabilizing device has compressible resilience in the axial direction; the strip-shaped texture is distributed along the oblique direction toward the distal end At the distal end region of the stabilization device, the distal end portion of the stabilization device is made to have a resiliency that can dilate and increase in the radial direction; or the adaptive device is directly made of a resilient material.

Preferably, the distal region of the injection tube is provided with an adaptive bending structure, and the bending control mechanism includes a distal fixing member, a bendable section, a bending control member and the bending control handle; wherein, the bendable section Located at the distal end region of the outer tube, the bendable section partially or completely covers the adaptive bending structure in the axial direction; the distal end of the bending control member is connected to the outer tube through the distal fixing member The tube is fixedly connected; the bending control handle includes a bending control operation part, a bending control control part and a bending control seat, and the proximal end of the bending control part is fixedly connected with the bending control control part; operating the bending control operation part, The bending control member drives the bending control member to move axially to realize the bending of the distal part of the myocardial filling system; the bending control member is axially laid in the outer tube wall or outside the outer tube The bending control wire, or the bending control piece is a bending control tube sleeved in the outer tube.

Preferably, the bending control member is a bending control tube sleeved in the outer tube, the outer tube and the bending control tube are coaxially slidably fitted, and the bendable sections of the outer tube are a plurality of hollow structures A, the hollowed-out structure A is a narrow strip-shaped through slot, and a plurality of hollowed-out structures A are parallel to each other and surround the outer tube; in the bendable section of the outer tube, the bending control tube is provided with A plurality of hollow structures B, the hollow structures B are narrow strip-shaped through grooves, the hollow structures B are parallel to each other, and surround the control elbow, and the hollow structures A and the hollow structures B are on the shaft. Partially or fully coincident in the upward direction, but separated on both sides of the pipe wall.

Preferably, the outside of the bendable section area of the outer tube is sealed and covered with an outer tube seal that is synchronously bent with the bendable section; a control elbow seal is fixedly connected in the outer tube handle The bend control pipe passes through the bend control pipe seal and the two form a sliding seal fit; an injection pipe seal is provided on the bend control control part, and the injection pipe passes through the injection pipe to seal The outer tube seal, the elbow control tube seal and the injection tube seal form the suction tube and the three-dimensional space enclosed by the injection tube and the outer tube. A suction cavity, the suction hole, the suction cavity and the outer tube handle through hole provided in the outer tube handle form a suction channel.

Preferably, a bend control tube through hole is provided on the bend control tube between the distal end of the bend control tube seal and the proximal end of the outer tube, and the suction channel includes the bend control tube. The pipe through hole makes the gas communication between the outer pipe handle through hole and the adsorption hole through the control bend pipe through hole.

Preferably, the outer surface of the injection tube is fixedly provided with local raised structures, which are integrally designed with the injection tube. The tubes form a coaxial slip fit.

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 limited to the outer tube handle or the bending control mechanism. The needle outgoing stroke control mechanism realizes the stroke control of the injection needle extending out of the guide device; the needle outgoing limit control mechanism limits the maximum stroke of the injection needle extending out of the guide device.

Further, the needle exit stroke control mechanism includes a stroke control member and a stroke control operation portion, the stroke control member is limitedly connected or fixedly connected with the injection tube, and the stroke control operation portion is operated to make the injection needle. Relative to the guide device, it is extended in a stepwise or continuous manner to realize the stroke control of the injection needle extending out of the guide device; the needle exit limit control mechanism includes a limit control member and a limit control operation part, the The limit control member realizes axial sliding relative to the needle outlet seat, so that the limit control member can abut against the stroke control member, and the needle outlet limit control mechanism restricts the injection needle to protrude from the guide The maximum travel of the device.

Preferably, the bending control mechanism is provided with a bending control angle mark, or the needle exit handle is provided with a needle exit scale mark for easy observation by the operator, and the needle exit scale mark includes a scale line, a stroke pointer and/or A limit pointer, the scale line is located on the needle outlet seat, the stroke pointer is fixedly arranged on the stroke control member, and the limit pointer is fixedly arranged on the limit control member.

Preferably, a filter structure is fixedly disposed 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, and liquid cannot pass through the micropores.

Preferably, a monitoring mechanism is provided at the distal end region of the myocardial filling system, and the monitoring mechanism is a visual window penetrating the tube wall of the outer tube and the elbow control tube, or the monitoring mechanism is made of a light-transmitting tube. An observation part made of a flexible material, the observation part is part or all of the injection tube, the outer tube, the elbow control tube, the outer tube seal and/or the adaptive device, having Aided to observe the effect of needle placement.

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

1. The negative pressure adsorption device provided by the present invention, when injecting fillers, especially fillers with high viscosity, into non-cavity areas of human tissues, such as muscles, or moving human tissues such as myocardium, etc., through negative pressure suction. The suction device will stabilize the device and the target tissue to form a negative pressure state, which fundamentally prevents the filler from being reversely squeezed during the injection process due to the poor diffusion of the filler in the tissue or the self-tension or movement force of the tissue. Out of the injection area, that is, the phenomenon that the filler leaks back from the human tissue in this area, ensures that the injection amount entering the target tissue is accurately controlled, and finally maximizes the degree of tissue filling. Therefore, the injection of the present invention is safe, reliable and controllable, and the filling effect Excellent.

2. The stabilization device provided by the present invention is provided with an adaptive device, so that after the stabilization device is attached to the surface of the target tissue, adaptive deformation occurs, completely avoiding the difference in the surface morphology of the target tissue due to different acupuncture points, or the myocardial filling system relative to the target tissue surface. The inclination angle of the target tissue is different, which makes the needle insertion angle different, which makes the needle insertion difficult or impossible, and finally ensures the targeted needle insertion and subsequent injection filling operations are smooth. It is easy to continuously maintain a negative pressure state between the stabilization device and the target tissue, so that the negative pressure suction device can continue to effectively perform its intended function.

3. The injection needle provided by the present invention has both the first form and the second form, and the injection needle cooperates with the guide device, which facilitates the safe and smooth needle ejection of the injection needle along the injection needle guide hole of the guide device, and realizes targeted injection The accurate positioning of the point on the target tissue avoids the high risk of needle bending or needle breakage. With the help of the needle stroke control mechanism, the injection needle can be easily and quickly pierced into the target tissue, and the targeted needle insertion is convenient and easy to withdraw. The injection needle, the safe and reliable performance characteristics of the whole process; in addition, after the injection needle protrudes out of the injection needle guide hole, the injection needle with the second form is in a curved arc shape, which is helpful for the continuous injection of the injection needle in the heart. It remains relatively still with the target tissue under beating, preventing accidental needle removal during needle sticking and injection, and avoiding the occurrence of filler leakage.

4. The needle exit limit control mechanism provided by the present invention can control the maximum depth of the injection needle pierced into the target tissue according to the actual clinical needs, that is, by controlling the needle exit limit control mechanism to send the injection needle to a predetermined depth. Precisely control the injection depth of the injection needle to avoid penetrating too deeply, causing the needle tip to penetrate the entire target tissue, such as the myocardial wall, causing the filler to be injected unpredictably outside the target tissue, such as the ventricular cavity or coronary blood , eventually causing a life-threatening medical accident, the invention is convenient to operate, and the injection is safe and reliable.

5. The bend adjustment mechanism and the bend control angle indicator provided by the present invention are suitable for minimally invasive surgery or interventional surgery, and are especially suitable for myocardial injection that requires multiple point selection, targeted positioning, injection depth and injection volume that are precisely controllable Filling operation realizes the multi-directional and multi-operation space injection of the myocardial filling system, so the design is reliable in structure, safe, fast and controllable in operation.

6. In the present invention, a detachable connection structure is provided between the feeding device and the injection assembly, so that during the injection process, the injection can be filled, loaded and injected in time for multiple times.

7. The technical solutions provided by the present invention, especially the stabilization device and the self-adaptive device, can realize the successful injection of high-viscosity injections without increasing the diameter of the injection needle, with low or almost no human tissue. The advantage of leakage is that it is suitable for minimally invasive surgery or interventional surgery, especially the minimally invasive surgery of myocardial injection filling through a small incision in the chest to the outer surface of the heart under a laparoscope. It does not affect the opening size of the above surgery and reduces the risk of surgery.

Description of drawings

1 is a schematic diagram of the overall structure of the myocardial filling system in Embodiment 1 of the present invention;

Fig. 2 is the overall appearance view of the handle in the first embodiment of the present invention;

3 is a cross-sectional view of the handle along the axis of the suction channel in Embodiment 1 of the present invention;

FIG. 4 is a schematic cross-sectional view of the needle out handle in Embodiment 1 of the present invention;

5 is a schematic cross-sectional view of the outer tube assembly in the first embodiment of the present invention;

6a is a schematic diagram of a specific implementation of the bendable section on the outer tube in the first embodiment of the present invention;

Figure 6b is a schematic diagram of a specific implementation of the upper bendable section of the central control bending member according to the first embodiment of the present invention;

6c is a schematic cross-sectional view of the placement relationship between the outer tube and the bending control member in Embodiment 1 of the present invention;

7a-7b are schematic diagrams of specific implementations of the bending direction of the myocardial filling system in the first embodiment of the present invention;

8 is a schematic cross-sectional view of the inner seal of the outer tube assembly in the first embodiment of the present invention.

9 is a schematic cross-sectional view of an injection tube in Embodiment 1 of the present invention;

FIG. 10 is a schematic structural diagram of a suction channel in Embodiment 1 of the present invention.

11 is a front view of the guide device in the first embodiment of the present invention;

12 is a rear view of the guide device in the first embodiment of the present invention;

13 is a schematic diagram of a scale mark in Embodiment 1 of the present invention;

14 is a schematic cross-sectional view of the reinforcing area of the injection tube in Embodiment 1 of the present invention;

15 is a schematic cross-sectional view of the circular groove C in the middle end region of the reinforcing pipe in the first embodiment of the present invention.

FIG. 16 is a schematic diagram of a specific implementation of the groove D in the proximal end region of the reinforcing tube in the first embodiment of the present invention.

17a-17c are schematic diagrams of specific implementations of the state of the injection needle in the second embodiment of the present invention.

18 is a cross-sectional view of the guide device in the second embodiment of the present invention along the axis of the guide hole of the injection needle.

FIG. 19 is a schematic diagram of a specific implementation of the wrinkle structure in Example 3 of the present invention.

FIG. 20 is a schematic diagram of a specific implementation of the wrinkle structure in the third embodiment of the present invention.

21a-21b are schematic diagrams of specific implementations of the wrinkle structure in Example 3 of the present invention.

22 is a schematic diagram of a specific implementation of the enhanced adsorption structure in Example 3 of the present invention.

FIG. 23 is a schematic diagram of a specific implementation of the wall thickness gradient structure in Example 3 of the present invention.

FIG. 24 is a schematic diagram of a specific implementation of the filtering structure in the fourth embodiment of the present invention.

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

FIG. 26 is a schematic diagram of a specific implementation of the injection control device in the sixth embodiment of the present invention.

FIG. 27 is a schematic diagram of the specific implementation of the double-lumen injection tube in the seventh embodiment of the present invention.

28 is a schematic cross-sectional view of the reinforced area of the double-lumen injection tube in Embodiment 7 of the present invention.

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

FIG. 30 is a schematic diagram of a specific implementation of the groove D in the proximal end region of the reinforcing tube in the seventh embodiment of the present invention.

FIG. 31 is a schematic diagram of a specific implementation of the outer tube assembly in the eighth embodiment of the present invention.

32 is a schematic diagram of a specific implementation of the suction channel in the eighth embodiment of the present invention.

Fig. 33 is a schematic diagram of a specific implementation of the needle out handle in the ninth embodiment of the present invention.

The symbols in the figure indicate the description:

1-stabilizing device, 11-adaptive device, 111-enhancing adsorption structure, 112-gradient structure, 12-negative pressure suction device, 121-suction power source, 122-suction cavity, 2-injection device, 21- Injection assembly, 211-injection needle, 212-injection tube, 2121-extraction judgment tube, 2122-injection filling tube, 2123-fixing tube, 2124-feeding cavity, 2125-injection cavity, 2126-communication port, 213-injection interface , 214-injection tube seal, 215-strengthened tube, 2151-circular groove C, 2152-groove D, 216-flexible tube, 217-injection control device, 2171-injection piston, 2172-piston push rod, 2173-fill Feeding device, 2174-Forcing 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-Bend control Mechanism, 22131-Distal Fixing Piece, 22132-Bendable Section, 22133-Bending Control Piece, 221331-Bending Control Tube Through Hole, 22134-Bending Control Handle, 221341-Bending Control Seat, 221342-Bending Control Operation Section, 221343- Bend Control, 22135-Control Bend Tube Seal, 2214-Outer Tube Seal, 222-Needle Out Handle, 2221-Out Needle Seat, 2222-Needle Out Stroke Control Mechanism, 22221-Stroke Control, 22222-Stroke Control Operation part, 22223-stroke pointer, 22224-push button, 22225-stroke controller, 22226-stroke controller fixing piece, 22227-stroke guide rail, 2223- needle out limit control mechanism, 22231-limit control piece, 22232- Limit control operation part, 22233-limit pointer, 2224-holding part, 22241-groove, 22242-through hole, 23-filter structure, 24-monitoring mechanism, 241-visual window, 242-observation part, 3- Guide device, 31-injection needle guide hole, 32-adsorption hole, 4-filler.

detailed description

The present invention provides a myocardial filling system, comprising a stabilization device 1, an injection device 2, a guide device 3 and a filler 4; wherein, the stabilization device 1 at least includes an adaptive device, and the adaptive device is fixedly arranged at the distal end of the myocardial filling system , the self-adaptive device has a morphological self-adaptive structure, when the self-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 at least includes an injection assembly 21 and an injection control mechanism 22, the injection assembly 21 includes an injection needle 211 and an injection tube 212, and the filler 4 can be injected into the myocardial tissue in a controlled manner through 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 self-adaptive device. The guide device is provided with an injection needle guide hole 31 that forms a sliding fit with the injection needle 211 to realize the positioning of the injection needle 211 on the myocardial tissue. and needle out function.

The advantage of the above design of the injection needle guide hole is that it can limit the needle exit position of the injection needle, achieve accurate positioning of the injection point on the target tissue, and avoid the high risk of needle bending or needle breakage. The control mechanism realizes the easy and fast performance of the injection needle piercing into the target tissue, and achieves the performance characteristics of convenient targeted needle insertion, easy withdrawal of the injection needle, and safety and reliability in the whole process.

In one embodiment, the stabilization 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 cavity 122 . The suction power source 121 is located outside the myocardial filling system, and is on the guide device 3 An adsorption hole 32 is provided, and the self-adaptive device forms gas communication with the adsorption hole 32 , the suction cavity 122 and the suction power source 121 to realize the negative pressure suction function.

The advantage of the above negative pressure suction device design is that, in the working state, the stabilization device 1 forms a negative pressure state with the target tissue, which fundamentally prevents the filler 4 from diffusing in the tissue poorly or accompanying the injection during the injection process. Caused by the self-tension or motion force of the target tissue, it is reversely squeezed out of the injection area, that is, the phenomenon that the filler leaks back from the human tissue in this area, ensuring that the injection volume into the target tissue is accurately controlled, so that the degree of tissue filling Therefore, the injection of the present invention is safe and controllable, and the filling effect is excellent.

In one embodiment, the injection control mechanism 22 at least includes an outer tube assembly 221 and a needle exit handle 222 , the outer tube assembly includes an outer tube 2211 , an outer tube handle 2212 and a bending control mechanism 2213 , and the outer tube handle 2212 is fixedly disposed on the outer tube 2211 . At the proximal end, the outer tube handle 2212 is axially limited or fixedly connected to the bending control mechanism 2213 , the injection assembly 21 penetrates the outer tube assembly 221 , and the needle outlet handle 222 is disposed on the injection tube 211 .

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 end area of the outer tube 2211, and the bendable section 22132 partially or completely covers the adaptive bending structure in the axial direction; ; Bend control handle 22134 includes a bend control operation part 221342, a bend control part 221343 and a bend control seat 221341, the proximal end of the bend control part 22133 is fixedly connected with the bend control part 221343; 221343 drives the bending control member 22133 to move axially to realize the bending of the distal part of the myocardial filling system.

In a preferred embodiment, the bending control member 22133 is a bending control wire axially laid in 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 in the outer tube 2211 .

In a preferred embodiment, the bend control member 22133 is a bend control tube sleeved in the outer tube 2211, the outer tube 2211 and the bend control tube are coaxially slidably fitted, and the bendable section 22132 of the outer tube 2211 is a plurality of hollow structures A. The hollow structure A is a narrow strip-shaped through slot, and a plurality of hollow structures A are parallel to each other and surround the outer tube 2211; in the bendable section 22132 of the outer tube 2211, the control elbow is provided with a plurality of hollow structures B, which are hollowed out. The structure B is a narrow strip-shaped through slot, and the multiple hollow structures B are parallel to each other and surround the control elbow. both sides of the pipe wall.

When the bending control operation part 221342 is operated to drive the bending control member 221343 to move axially to the distal end, the bending control member 22133 moves axially to the distal end at the same time, and the hollow structure B in the distal region of the bending control member 22133 is gradually opened so that the bending control member 22133 is gradually opened. The member 22133 is bent in one direction to a certain angle, and at the same time, the hollow structure A in the distal region of the outer tube 2211 is gradually closed, so that the outer tube 211 is bent to the same angle in this direction, and the bending direction of the distal part of the myocardial filling system is shown in Figure 7a; when When the bending control operation portion 221342 is operated to drive the bending control member 221343 to move axially towards the proximal end, the bending control member 22133 moves axially towards the proximal end at the same time, and the hollow structure B in the distal region of the bending control member 22133 is gradually closed so that the bending control member 22133 Bending to a certain angle in the other direction, while the hollow structure A in the distal region of the outer tube 2211 is gradually opened, so that the outer tube 211 is bent to the same angle in this direction. The bending direction of the distal part of the myocardial filling system is shown in Figure 7b.

The advantage of the design of the above-mentioned bending control mechanism 2213 is that the bending control structure can precisely control the angle change of the bendable section 22132 area, and the angle of the bendable section 22132 can be adjusted according to actual needs, which is suitable for minimally invasive surgery or interventional surgery, especially suitable for Myocardial injection filling surgery that requires up to 20 times of selection and targeting, and requires precise and controllable injection depth and injection volume. The minimally invasive approach (epicardium) or the interventional approach via the femoral artery approach along the arterial system to the inner surface of the heart (the endocardium of the left ventricular cavity) can achieve multi-directional and multi-operating space injection of the myocardial filling system , so the design is reliable in structure, safe in operation, fast and controllable.

In a specific embodiment, outside the area of the bendable section 22132 of the outer tube 2211, an outer tube seal 2214 that bends synchronously with the bendable section 22132 is sealed and wrapped, and the distal area of the outer tube seal 2214 It is tightly connected with the adaptive device 11, and its proximal end region is tightly connected with the distal part of the outer tube handle 2212. A control elbow seal 22135 is fixedly connected in the outer tube handle 2212, and the control elbow 22133 passes through the control tube. The elbow 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 212 passes through the syringe seal 214 and the two form a sliding seal fit.

The arrangement of the above-mentioned outer tube seal 2214, control elbow 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, and prevents the system from falling off during the injection process. The occurrence of safety accidents can also prevent the sliding from being too tight due to the tight fit.

Further, the outer tube seal 2214, the control elbow seal 22135, the injection tube seal 214, and 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 forms a suction channel.

Further preferably, a control bend pipe through hole 221331 is provided on the control bend pipe 22133 between the distal end of the control bend pipe seal 22135 and the proximal end of the outer pipe 2211, and the suction channel includes the control bend pipe through hole 221331, The through hole 22121 of the outer tube handle and the adsorption hole 32 are in gas communication through the through hole 221331 of the controlled elbow.

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

In a preferred embodiment, the proportion of the adsorption hole 32 in the guide device 3 is 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, the space of the cross section of the suction cavity 122 is 0.1 to 20 mm ² , and the area of the through hole 221331 of the control elbow is 3 to 30 mm ² . After many in vitro tests and animal experiments Repeated verification can ensure that the stabilization device does not loosen from the surface of the target tissue when subjected to a large tensile force (eg 15N).

In a specific embodiment, as shown in FIG. 4 , the needle outlet handle 222 includes a needle outlet seat 2221, a needle outlet stroke control mechanism 2222 and/or a needle outlet limit control mechanism 2223, the needle outlet seat 2221 and the outer tube handle 2212 or The bending control mechanism 2213 is axially limited or fixedly connected. The needle exit stroke control mechanism 2222 realizes the stroke control of the injection needle 211 extending out of the guide device 3 , and the needle exit limit control mechanism 2223 limits the maximum stroke of the injection needle 211 extending out of the guide device 3 .

In the first embodiment, the needle out handle 222 includes a needle out seat 2221, a needle out stroke control mechanism 2222 and a needle out limit control mechanism 2223, and the needle out stroke control mechanism 2222 includes a stroke control member 22221 and a stroke control operation part 22222 , the stroke control member 22221 is connected with the injection tube 212 to achieve a limit connection or a fixed connection, and the stroke control operation part 22222 is operated, so that the injection needle 211 is protruded in a stepwise or continuous manner relative to the guide device 3, so that the injection needle 211 can extend out of the guide device. 3 stroke control; the needle exit limit control mechanism 2223 includes a limit control member 22231 and a limit control operation part 22232, and the limit control member 22231 realizes axial sliding relative to the needle exit seat 2221, so that the limit control member 22231 can reach the Relying on the stroke control member 22221 , the needle exit limit control mechanism 2223 limits the maximum stroke of the injection needle 211 extending out of the guide device 3 .

In another embodiment, the needle outlet handle 222 includes a needle outlet seat 2221, a needle outlet stroke control mechanism 2222 and a grip portion 2224, and the needle outlet seat 2221 and the outer tube handle 2212 are axially limited or fixedly connected , the needle out stroke control mechanism 2222 includes a push button 22224, a stroke controller 22225, a stroke controller fixing member 22226 and a stroke guide rail 22227. The stroke controller 22225 is fixedly connected with the injection tube 212, and a groove 22241 is fixed in the distal region of the grip portion 2224. The depth of the distal region of the groove 22241 is deeper than that of the proximal region, which is the thickness of the stroke guide rail 22227, but not the same as that of the stroke guide rail 22227. Passing through the gripping portion 2224, the travel guide rail 22227 is ratchet-shaped, and is fixedly arranged in the distal region of the groove 22241. The proximal region of the groove 22241 is provided with a through hole 22242 penetrating the gripping portion, and the push button 22224 is provided in the In the groove 22241, 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 rail 22227, and the push button 22224 is operated so that the injection needle 211 is opposite to each other. Since the guide device 3 is extended step by step, the stroke control of the injection needle 211 extending out of the guide device 3 is realized.

The advantages of the above two stroke control designs are that the penetration depth of the injection needle can be controlled according to clinical needs, the needle withdrawal stroke of the injection needle can be precisely controlled, the injection precision is improved, and the needle tip of the injection needle is prevented from being penetrated too deeply. The whole target tissue can reduce the risk in the injection process, and the operation is convenient and the injection is safe and reliable.

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

In a preferred embodiment, the bend control mechanism 2213 is provided with a bend control angle mark, or the needle exit handle 222 is provided with a needle exit scale mark that is convenient for the operator to observe, as shown in FIG. 13 , the needle exit scale mark includes a scale The line 22211, the stroke pointer 22223 and/or the limit pointer 22233, the scale line 22211 is located on the needle outlet seat 2221, the stroke pointer 22223 is fixed on the stroke control member 22221, and the limit pointer 22233 is fixed on the limit control member 22231, The limit pointer 22233, the needle outlet seat 2221, and the stroke pointer 22223 are arranged coaxially from far to near, and the actual needle out length of the injection needle 211 is confirmed by judging the position of the stroke pointer 22223.

The advantage of the above scale mark design is that the increase of mark scale lines on the needle outlet seat can clearly determine the specific position of the stroke pointer and the limit pointer, and by judging the position of the pointer, the real-time position of the injection needle of the system can be directly judged. Accurately control the needle penetration depth of the injection needle, further improve the needle penetration accuracy of the injection needle, and avoid the needle tip of the injection needle being penetrated through the entire target tissue, such as the myocardial wall.

In a specific embodiment, as shown in Figs. 17a-17c, the injection needle 211 has shape memory, and is preferably preformed into a certain shape by an elastic metal tube, such as a curved arc, thus having both the first form and the second form form. When the needle tip of the injection needle 211 is located in the injection needle guide hole 31, as shown in FIG. 17a, it has the first form, that is, the straight state, which is convenient for the injection needle 211 to safely and smoothly exit the needle along the injection needle guide hole 31; operate the needle exit handle 222 can make the injection needle 211 protrude from the injection needle guide hole 31, and the injection needle 211 is gradually expanded in a predetermined shape until the needle is completely drawn out, as shown in Figures 17b-17c, and finally forms a second shape, that is, a curved arc shape , due to the design of the aforementioned negative pressure suction device, regardless of whether the surface of the target tissue is flat, or the inner or outer surface of the heart is curved and uneven, the target tissue can be adsorbed into the adaptive device and touch The distal surface of the guide device 3, on this premise, the injection needle that is pre-shaped into a curved arc can easily achieve the function of puncturing the target tissue. Of course, in the second form, the cutting edge of the injection needle 211 should be oriented away from the myocardial filling system, and the movement trajectory of the injection needle 211 is arc-shaped, so as to prevent the cutting edge from scratching the inner wall of the injection needle guide hole and affecting the needle ejection The injection needle guide hole 31 on the guide device 3 can ensure that the second form of the injection needle 211 remains relatively static relative to the myocardial filling system to a certain extent, so that in the whole process of the subsequent injection, the injection needle includes The position of the needle tip in the target tissue remains unchanged, and finally a specific amount or volume of filler can be injected into the target tissue at a predetermined position, and precise control of the injection depth can be achieved.

In a preferred 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≤8 mm, and the injection in the guide device 3 The size of the needle guide hole 31 is to fit the outer diameter of the injection needle 211, and the fit gap does not exceed 0.1 mm.

The above-mentioned design with both the first form and the second form also keeps the injection needle and the target tissue relatively still, which improves the safety during the injection process, reduces the risk of the injection needle falling off accidentally during the beating of the target tissue, and avoids the occurrence of filler leakage. . The edge of the injection needle is oriented to help the filler in the target tissue to be squeezed away from the myocardial filling system, which significantly improves the filling effect of the filler.

In a preferred embodiment, as shown in FIG. 14 , the injection tube 212 can be deformed adaptively. From the proximal end region of the injection tube 212 to the injection interface 213 , a reinforcement tube 215 is fixedly arranged, and at the proximal end of the reinforcement tube 215 , a reinforcement tube 215 is fixedly arranged. The area is covered with a layer of flexible pipe 216 . The advantage of the above-mentioned design of the reinforcing tube 215 and the flexible tube 216 is that the addition of the reinforcing tube 215 can improve the bending resistance of the injection tube 212 in the handle area and the handle exposed area, and prevent the injection tube 212 from being adaptively deformed during the pushing process. When the injection tube is moved a certain distance in the distal direction, the injection needle also moves the same distance, thus ensuring precise control of the length of the needle and the speed of the needle, which further improves the safety of the myocardial injection system and also helps to strengthen the injection depth Of course, it also prevents the system from being unusable under unexpected circumstances, such as falling, not being placed in place, etc., and the addition of the flexible tube 216 reduces the rigidity of the reinforcing tube 215 to a certain extent, preventing the injection tube 212 from operating Bending or breaking events are unavoidable during the process, thus improving system comfort, safety and durability.

Further preferably, a plurality of circular grooves C are provided in the middle end area of the reinforcing pipe 215. As shown in FIG. 15, the circular grooves C 2151 are through holes passing through the reinforcing pipe 215, and are distributed in the middle section of the reinforcing pipe 215. The injection of glue adopts a connection method such as gluing, and the injection tube 212 is fixedly connected, and a plurality of grooves D are arranged in the proximal area of the reinforcement tube 215. As shown in FIG. 16, the groove D 2152 is a π-shaped groove running through the reinforcement tube 215. The flexible tube 216 completely covers the groove D and is spirally distributed in the proximal end region of the reinforcing tube 215 to improve the flexural resistance of the injection tube 212 .

The design of the stabilization device 1 and the self-adaptive device 11, especially the self-adaptive device 11 has a compressible resilience, which can realize the successful injection of high-viscosity injections without increasing the diameter of the injection needle, and has a relatively high performance. The advantage of low or almost no leakage of human tissue is suitable for minimally invasive surgery or interventional surgery, especially the minimally invasive surgery for myocardial injection filling through a small incision in the chest to reach the outer surface of the heart under a laparoscope, without affecting the size of the opening of the above surgery, Reduce the risk of surgery. In one embodiment, the adaptive device 11 is a wrinkled structure, and the wrinkled structure includes one or more of the following ring textures, arc textures, and strip textures:

(1) As shown in FIG. 19 , the annular texture is annularly distributed on the stabilizing device along the circumferential direction of the stabilizing device, so that the stabilizing device 1 has compressible resilience in the axial direction. The advantage of the annular texture design is that after the stabilization device 1 is adsorbed on the target tissue, it undergoes adaptive deformation and can be freely rotated in a circumferential angle, thereby improving the range of motion of the device. For myocardial injection filling, even a minimally invasive operation The channel has relative limitations, and it can also take advantage of the adaptive strain of the adaptive device to achieve multiple point selection and accurate targeting on the surface of the heart, and then combined with the design of the aforementioned negative pressure suction device, and finally To ensure the smooth operation of multiple needle insertions and subsequent injections of fillers, of course, the annular texture can continuously adapt to the beating of the target tissue, which is convenient to maintain a negative pressure state between the stabilization device 1 and the target tissue. The pressure suction device 12 continues to effectively perform its intended function;

(2) As shown in FIG. 20 , when the wrinkle structure is an arc-shaped texture, the arc-shaped texture is annularly distributed in the proximal region of the stabilization device 1 along the circumferential direction of the stabilization device 1 , so that the stabilization device 1 is in the axial direction. It has compressible resilience. The advantage of the arc-shaped texture design is that after the stabilization device 1 is adsorbed on the target tissue, it undergoes adaptive deformation, but it can only move in the direction limited by the arc-shaped texture, which avoids the surface morphology of the target tissue due to the needle point to a certain extent. The difference in chemical treatment makes it difficult or impossible to puncture the needle, ensuring the smooth needle puncturing process, and the arc-shaped texture can continuously adapt to the beating of the target tissue, which is convenient for the stabilization device 1 and the target tissue to maintain a negative pressure state, so that the negative pressure The suction device 12 continues to effectively perform its intended function;

(3) As shown in Figs. 21a-21b, when the wrinkle structure shown is a stripe texture, the stripe texture is distributed in the distal region of the stabilization device 1 along the oblique direction toward the distal end, so that the distal end portion of the stabilization device 1 It has a resilience that can expand and expand. When the stabilization device 1 is in a natural unconstrained state, the wrinkled structure is fully expanded, and the maximum diameter can exceed 10mm. When the stabilization device 1 is in a compressed state, the strips can be stacked in a certain way. After compression, it can be reduced to 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 endoscopic surgery. The advantage of this design is that the strip-shaped texture adapts to the beating of the target tissue, which can increase the contact area between the stabilization device 1 and the target tissue, improve the adsorption, and facilitate the maintenance of a negative relationship between the stabilization device 1 and the target tissue. pressure state.

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

In a preferred embodiment, as shown in FIG. 22 , the stabilization device 1 is provided with an enhanced adsorption structure 111 . The enhanced adsorption structure 111 is convex in the waist region of the stabilization device 1 and converges toward the distal end. This design not only makes The volume enclosed by the stabilization device 1 is maximized, and the volume of the target tissue adsorbed to the inner cavity of the stabilization device 1 increases accordingly, thereby significantly improving the adsorption efficiency, helping to maintain a negative pressure state between the stabilization device 1 and the target tissue, and avoiding The edge of the distal end of the stabilization device may be turned toward the proximal end, resulting in a warped edge, which affects the adsorption effect.

In another preferred embodiment, as shown in FIG. 23 , the stabilization device 1 is provided with a gradient structure 112 , and the gradient structure 112 is a gradual transition from thick to thin at the waist of the stabilization device 1 and toward the distal region, so that the stabilization device The strength of 1 is improved, 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 region is preferably designed to be 1-1.5mm, and the wall thickness of the distal end is 0.2 mm. ~0.5mm.

In one embodiment, the outer surface of the injection tube 212 is fixedly provided with local raised structures, which are integrally designed with the injection tube 212. The raised structures are distributed in dots or strips, so that the injection tube 212 and the outer tube 2211 can be formed in the same way. The shaft is slidably fitted, and after the raised structure contacts the outer tube 2211, it can prevent the injection tube 212 from being folded or deformed during the axial sliding process, resulting in a decrease in the needle ejection precision of the injection needle 211, thus playing the same role as the aforementioned reinforcing tube 215. Efficacy, not only that, the raised structure also greatly reduces the contact area between the injection tube 211 and the outer tube 2211, significantly reduces frictional resistance, increases the space of the suction channel, and greatly improves the adsorption efficiency.

In one embodiment, as shown in FIG. 24 , a filter structure 23 is fixedly disposed at the distal end of the guide device 3 , and the filter structure 23 has one or more micropores, so that gas can pass through the micropores, and liquid cannot pass through the micropores. When the system is in working state, the stabilization device 1 can still be adsorbed on the target tissue, and the adsorption force is basically the same as that before the filter structure 23 is not added. The filler 4 leaks from the target tissue, and the filler 4 can be blocked on the filter structure 23 to prevent it from being sucked back into the suction cavity 122 under a negative pressure state, causing the suction channel to be blocked, which is helpful for multiple multi-points of the system. Injection, fully ensure the reusability of the system; in addition, the filter structure 23 covers the guide device 3 to increase the contact area, prevent the target tissue from being damaged when the target tissue is attached to the guide device 3, and improve safety.

In one embodiment, as shown in Figure 25, a monitoring mechanism 24 is provided in the distal region of the myocardial filling system. The monitoring mechanism 24 is a viewing window 241 penetrating the tube walls of the outer tube 2211 and the control bend tube 22133, or the monitoring mechanism 24 is made of a light-transmitting material. , the control elbow 22133, the outer tube seal 2214 and/or part or all of the adaptive device 11, the monitoring mechanism 24 is designed to have the advantage that, during the injection process, the depth of the needle at the location of the injection needle and the depth of the needle can be monitored in real time. The position of the injection tube can better judge the effect of the needle and the injection progress of the filler, and improve the safety.

In one embodiment, the injection assembly 21 further includes an injection control device 217. The injection control device 217 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. It is fixedly arranged at the distal end of the piston push rod 2172, and the injection piston 2171 can realize sliding sealing cooperation with the injection tube 212; the piston push rod 2171 is made of solid material, and the proximal end of the piston push rod 2171 is provided with a grip The holding portion 2174 can transmit force in the axial direction, and pushing the piston push rod 2171 can realize the axial movement of the injection piston 2171 in the injection tube 212 .

In one embodiment, a detachable connection structure is provided between the feeding device 2173 and the injection assembly 21; further, the feeding device 2173 is provided at the proximal end of the injection tube 212, and is an adjustable device. When the filler 4 is added to the tube 212, the feeding device 2173 is in an open state; when the myocardial filling system is in a working state of injection, the feeding device 2173 is in a closed state. This design facilitates the operator to conveniently and quickly refill the injection 4 into the injection tube 212 in the myocardial injection filling operation with up to 20 selected and targeted injections, thus meeting the requirement of multiple injections 4. Timely fill loading and injection.

The present invention will be described in detail and concretely below through specific embodiments, so as to make the present invention better understood, but the following embodiments do not limit the scope of the present invention.

Example 1

This embodiment provides a myocardial filling system (hereinafter referred to as "the system"), which is composed of a stabilization device 1 , an injection device 2 , a guide device 3 and a filler 4 . As shown in FIG. 1 , the stabilization device 1 is fixedly arranged at the distal end of the injection device 2 to be attached to the surface of the myocardial tissue. The stabilization device 1 is provided with an adaptive device 11 , so that the stabilization device 1 can be adaptively deformed to achieve Relative stationary motion of a stabilization device on myocardial tissue. The stabilization device 1 also includes a negative pressure suction device 12, which includes a suction power source 121 and a suction cavity 122. The suction power source 121 is located outside the system, and the adaptive device 11 passes through the adsorption hole 32 provided in the guide device 3, It forms gas communication with the suction cavity 122 and the suction power source 121 to realize the negative pressure suction function.

In this embodiment, as shown in FIG. 1 , the injection device 2 includes an injection assembly 21 and an injection control mechanism 22 . The injection assembly 21 includes an injection needle 211 , an injection tube 212 , and an injection interface 213 . The injection interface 213 is fixedly arranged at the proximal end of the injection tube 212 , and the injection needle 211 , the injection tube 212 and the injection interface 213 can be in fluid communication, so that the filler 4 can enter the injection tube 212 from the injection interface 213 and be filled in the injection needle 211 The injection filling process of the filler 4 to the target tissue is completed by injecting it into or from the injection needle 211 .

In this embodiment, as shown in FIGS. 2-5 , the injection control mechanism 22 includes an outer tube assembly 221 and a needle out 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, and the outer tube 2211, the outer tube handle 2212 and the bending control mechanism 2213 are axial Limit connection or fixed connection, the injection assembly 21 penetrates the outer tube assembly 221; the needle out handle 222 is provided on the injection tube 212, including the needle out seat 2221, the needle out stroke control mechanism 2222, the needle out limit control mechanism 2223 and the grip The part 2224, the needle outlet seat 2221, the needle outlet stroke control mechanism 2222, the needle outlet limit control mechanism 2223 and the grip part 2224 are axial limit connection or fixed connection, and the axial direction of the injection assembly 21 is realized by operating the needle outlet handle 222. move. The outer tube handle 2212, the bending control mechanism 2213, and the needle outlet handle 222 form an integrated large handle.

In this embodiment, as shown in FIG. 4 , the needle withdrawal stroke control mechanism 2222 includes a stroke control member 22221 and a stroke control operation part 22222. The stroke control member 22221 is connected to the injection tube 212 by a limit connection or fixed connection, and the stroke control operation part 22222 is operated. , so that the injection needle 211 extends continuously or step by step relative to the guide device 3 to realize the stroke control of the injection needle 211 extending out of the guide device 3; the needle exit limit control mechanism 2223 includes a limit control member 22231 and a limit control The operating part 22232, the limit control member 22231 can slide axially relative to the needle outlet seat 2221, so that the limit control member 22231 can abut the stroke control member 22221, and the needle outlet limit control mechanism 2223 limits the injection needle 211 to extend out of the guide device 3 maximum strokes.

In this embodiment, as shown in FIG. 5 , the distal end 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. The bendable section 22132 is located at the distal end region of the outer tube 2211, and the bendable section 22132 partially or completely covers the adaptive bending structure in the axial upper direction.

In this embodiment, as shown in Figs. 6a-6c, the bend control member 22133 is a bend control tube, and the bendable section 22132 of the outer tube 2211 is a plurality of hollow structures A. As shown in Fig. 6a, the hollow structures A are narrow strip-shaped through-hole structures A. In the groove, a 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 bendable section 22132 provided by the control elbow is a plurality of hollow structures B, as shown in Figure 6b, hollow In the same way, the structure B is a narrow strip-shaped through slot, and the plurality of hollow structures B are parallel to each other and surround the control elbow. The two sides of the tube wall are distributed in opposite directions. As shown in Figure 6c, the bend control tube is fixedly connected to the distal end of the outer tube 2211 through the distal fixing member 22131. The bend control handle 22134 includes a bend control seat 221341 and a bend control operation part. 221342 and the bending control member 221343, the bending control member 221343 is fixedly connected with the proximal end of the bending control member 22133, and the bending control operation part 221342 is operated to drive the axial movement of the bending control member 221343 to realize at least the distal part of the myocardial filling system. Bend in both directions.

The specific working state is shown in Figures 7a-7b. When the bending control operation part 221342 is operated to drive the bending control member 221343 to move axially to the distal end, the bending control member 22133 moves axially to the distal end at the same time, and the distal end of the bending control member 22133 moves axially. The hollow structure B in the area is gradually closed, so that the bending control member 22133 is bent in one direction to a certain angle, and at the same time, the hollow structure A in the distal region of the outer tube 2211 is gradually opened, so that the outer tube 211 is bent in this direction to the same angle, and the myocardial filling system is far away. The bending direction of the end portion is shown in Figure 7a; when the bending control operation part 221342 is operated to drive the bending control member 221343 to move axially towards the proximal end, the bending control member 22133 moves axially towards the proximal end at the same time, and the distal region of the bending control member 22133 The hollow structure B is gradually opened, so that the bending control member 22133 is bent to a certain angle in the other direction, and the hollow structure A in the distal region of the outer tube 2211 is gradually closed, so that the outer tube 211 is bent to the same angle in this direction, and the myocardial filling system is far away. The bending direction of the end portion is shown in Fig. 7b.

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

In this embodiment, as shown in FIG. 8 and FIG. 10 , an outer tube seal 2214 that is synchronously bent with the bendable section 22132 is encapsulated in the outer seal of the area of the bendable section 22132 of the outer tube 2211 . The outer tube seal The distal region of 2214 is tightly connected with the adaptive device 11, and the proximal region thereof is tightly connected with the distal part of the outer tube handle 2212; the outer tube handle 2212 is fixedly provided with a bend-controlling tube seal 22135, which controls the bend The tube 22133 passes through the bend control tube seal 22135 and the two form a sliding seal; the injection tube seal 214 is fixedly connected in the bend control member 221343, the injection tube 212 passes through the syringe seal 214 and the two form a sliding seal Cooperate. The outer tube seal 2214, the control elbow seal 22135, and the injection tube seal 214 form a suction cavity 122 with the three-dimensional space enclosed by the injection tube 212 and the outer tube 2211, and the outer tube handle 2212 is provided with an outer tube handle through hole 22121, the outer tube handle through hole 22121, the adsorption hole 32 and the suction cavity 122 form a suction channel, and the external suction power source 121 realizes the negative pressure suction function.

In this embodiment, as shown in FIG. 10 , a control bend pipe through hole 221331 is provided on the control bend pipe 22133 between the distal end of the control bend pipe seal 22135 and the proximal end of the outer pipe 2211 , and the suction channel includes The through hole 221331 of the control elbow is formed, so that the through hole 22121 of the outer tube handle and the adsorption hole 32 are in gas communication through the through hole 221331 of the control elbow.

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

In this embodiment, as shown in FIGS. 10-12 , the guide device 3 is fixedly disposed at the distal end of the outer tube 2211 , and the guide device 3 is provided with an injection needle guide hole 31 and an adsorption hole 32 , and the injection needle guide hole 31 acts on the injection needle. The directional movement of 211 and the operation of the needle out handle 222 can make the injection needle 211 protrude from the injection needle guide hole 31 to achieve the function of piercing the target tissue.

In this embodiment, as shown in FIG. 10 , the proportion of the adsorption hole 32 in the guide device 3 is 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 cavity 122 is 50～1500mm, the space of the cross section of the suction cavity 122 is 0.1～3mm ² , and the area of the through hole 221331 of the control elbow is 3～30mm ² , which have been repeatedly verified by in vitro tests and animal experiments. , which can ensure that the stabilization device does not loosen from the surface of the target tissue when subjected to a large tensile force (eg, 15N).

In this embodiment, as shown in FIG. 13 , the bend control mechanism 2213 is provided with a bend control angle mark, and the needle exit handle 222 is provided with a needle exit scale mark that is convenient for the operator to observe. The needle exit scale mark includes a scale line 22211 and a stroke pointer. 22223 and/or limit pointer 22233, the scale line 22211 is located on the needle outlet seat 2221, the stroke pointer 22223 is fixed on the stroke control member 22221, the limit pointer 22233 is fixed on the limit control member 22231, the limit pointer 22233, The needle ejection seat 2221 and the stroke pointer 22223 are arranged coaxially from far to near, and the actual needle ejection length of the injection needle 211 is confirmed by judging the position of the stroke pointer 22223 .

In this embodiment, as shown in FIG. 14 , the injection tube 212 can be deformed adaptively. From the proximal end region of the injection tube 212 to the injection interface 213 , a reinforcement tube 215 is fixedly arranged, and outside the proximal end region of the reinforcement tube 215 A layer of flexible tube 216 is coated. The middle end area of the reinforcing tube 215 is provided with a plurality of circular grooves C. As shown in FIG. 15 , the circular grooves C 2151 are through holes passing through the reinforcing tube 215, and are distributed in the middle section of the reinforcing tube 215. The injection tube 212 is fixedly connected by means of gluing or the like; a plurality of grooves D are provided in the proximal end area of the reinforcing tube 215, as shown in FIG. At the proximal end region of the reinforcing tube 215, for improving the bending resistance of the injection tube 212, the flexible tube 216 completely covers the groove D.

In this embodiment, as shown in FIG. 9 , the outer surface of the injection tube 212 is fixedly provided with local raised structures, which are integrally designed with the injection tube 212 . The outer tube 2211 forms a coaxial slip fit.

Embodiment 2

As shown in Figures 17a-17c, this embodiment is based on Embodiment 1. The difference between this embodiment and Embodiment 1 is that the injection needle 211 has shape memory, and an elastic metal tube is used to preform a certain shape, such as bending Arc, thus having both the first form and the second form.

When the needle tip of the injection needle 211 is located in the injection needle guide hole 31, as shown in FIG. 17a, it has the first form, that is, the straight state, which is convenient for the injection needle 211 to safely and smoothly exit the needle along the injection needle guide hole 31; operate the needle exit handle 222 can make the injection needle 211 protrude from the injection needle guide hole 31, and the injection needle 211 is gradually expanded in a predetermined shape until the needle is completely drawn out. With the help of the aforementioned design of the negative pressure suction device, the function of piercing the needle into the target tissue can be easily realized. In the second form, the cutting edge of the injection needle 211 faces the direction away from the myocardial filling system, and the movement trajectory of the injection needle 211 is in an arc shape, leading to The injection needle guide hole 31 on the device 3 ensures that the second configuration of the injection needle 211 remains relatively stationary relative to the myocardial filling system.

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≤8 mm; as shown in FIG. 18 , inside the guide device 3 The size of the injection needle guide hole 31 is the outer diameter of the matching injection needle 211, and the matching gap does not exceed 0.1mm.

Embodiment three:

As shown in FIGS. 19-23 , this embodiment is based on Embodiment 1. The difference between this embodiment and Embodiment 1 is that the adaptive device 11 of the stabilization device 1 is a corrugated structure.

In this embodiment, the wrinkled structure includes one or more of annular textures, arc textures, and strip textures. As shown in FIG. 19 , the annular texture is annularly distributed on the stabilization device 1 along the circumferential direction of the stabilization device, so that the stabilization device 1 has compressible resilience in the axial direction. As shown in FIG. 20 , when the corrugated structure is an arc-shaped texture, the arc-shaped texture is annularly distributed in the proximal end region of the stabilization device 1 along the circumferential direction of the stabilization device 1 , so that the stabilization device 1 has a possible axial direction. Compression resilience. As shown in Figs. 21a-21b, when the corrugated structure shown is a strip-shaped texture, the strip-shaped texture is distributed in the distal region of the stabilization device 1 along the oblique direction toward the distal end, so that the distal portion of the stabilization device 1 has diastolic Increased resilience, when the stabilizer 1 is in a natural unconstrained state, the wrinkled structure is fully expanded, with a maximum diameter of more than 10mm. When the stabilizer 1 is in a compressed state, the strips can be stacked in a certain way, and can be compressed after compression. It can be narrowed to a lumen with a small inner diameter ID, so as to adapt to various access channels of the myocardial filling system to the myocardial surface, especially including the 5mm or 10mm puncture cannula lumen equipped for endoscopic surgery.

In the second embodiment, as shown in FIG. 22 , the stabilization device 1 is further provided with an enhanced adsorption structure 111 . The enhanced adsorption structure 111 is convex in the waist region of the adaptive device and converges toward the distal end, so that the adaptive device surrounds The formed volume is maximized, the adsorption efficiency is improved, and it is convenient to maintain a negative pressure state between the stabilization device 1 and the target tissue.

In the third embodiment, as shown in FIG. 23 , the stabilization device 1 is further provided with a gradient structure 112. The gradient structure 112 is a gradual transition from thick to thin at the waist of the adaptive device and toward the distal region. The wall thickness of the end region is 1 to 1.5 mm, and the wall thickness of the distal end is 0.2 to 0.5 mm.

Embodiment 4:

As shown in FIG. 24 , this embodiment is based on Embodiment 1. The difference between this embodiment and Embodiment 1 is that a filter structure 23 is fixedly disposed at the distal end of the guiding device 3 . The stabilization device 1 is fixedly arranged outside the filter structure 23 to prevent the filter structure 23 from falling off. The filter structure 23 has one or more micropores, so that the gas can pass through the micropores, and the liquid cannot pass through the micropores. When the myocardial filling system is working In the state, 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 not added.

Embodiment 5:

As shown in FIG. 25 , this embodiment is based on Embodiment 1. The difference between this embodiment and Embodiment 1 is that a monitoring mechanism 24 is provided in the distal region of the myocardial filling system. The monitoring mechanism 24 is a viewing window 241 penetrating the tube walls of the outer tube 2211 and the control bend tube 22133, or the monitoring mechanism 24 is made of a light-transmitting material. , the control elbow 22133, the outer tube seal 2214 and/or some or all of the adaptive device, have the functions to assist in judging the effect of the needle puncture and the actual injection progress of the filler.

Embodiment 6:

As shown in FIG. 26 , this embodiment is based on Embodiment 1, and the differences between this embodiment and Embodiment 1 are:

(1) In this embodiment, the injection tube 212 has a double-chamber structure, one cavity is the feeding cavity 2124 and the other cavity is the injection cavity 2125, and a communication port 2126 is provided at the front end of the injection tube 212, and the communication port 2126 makes the feeding cavity 2124 and the feeding cavity 2124. The injection cavity 2125 is in fluid communication.

(2) In this embodiment, an injection control device 217 is also 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 portion 2174, which can The force is transmitted 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, and the injection piston 2171 and the injection cavity 2125 realize sliding sealing cooperation, and the feeding device 2173 is set at the proximal end of the feeding chamber 2124 and is a commercially available three-way valve. When adding filler 4 to the feeding chamber 2124, the feeding device 2173 is in an open state; when the myocardial filling system is in the working state of injection, feeding Device 2173 is off.

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

Embodiment 7:

As shown in FIGS. 27-30 , this embodiment is based on Embodiment 1. The difference between this embodiment and Embodiment 1 is that the injection tube 212 in this embodiment is a double-chamber structure. As shown in FIG. 28 , the double-chamber structure It is composed of a combination of two layers of tubes, one layer of tube is the withdrawal judgment tube 2121, the other layer of the tube is the injection filling tube 2122, and the distal area of the double-lumen structure is wrapped with a layer of fixed tube 2123 of the same material, which will be withdrawn by hot melting. The contact parts of the judgment tube 2121, the injection filling tube 2122 and the fixing tube 2123 are connected together 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 arranged at the distal end of the injection tube 212. The proximal end of 211 is not in contact with the withdrawal judgment tube 2121 and the injection filling tube 2122, leaving a certain gap. The proximal ends of the withdrawal judgment tube 2121 and the injection filling tube 2122 are each connected with an interface 213, the injection needle 211, the injection tube 212, The injection interface 213 can form a fluid communication. During the injection process, when the injection needle 211 is inserted into the target tissue, the withdrawal judgment tube 2121 can be used to perform the withdrawal test first, and the injection filling tube 2122 can be used for filling after confirming the safety. 4 injections.

The advantage of the above two-layer tube combination design is that during the injection process, the withdrawal judgment tube can be used preferentially to judge whether the current position of the injection needle is suitable for injection, avoid the injection needle from piercing the target tissue, and reduce the injection penetration risk, improve the safety of the system, and then use the injection filling tube for injection to improve the injection efficiency of the system.

In another embodiment, as shown in FIG. 28 , both the retraction determination tube 2121 and the injection filling tube 2122 can be adaptively deformed, and the proximal end regions of the retraction determination tube 2121 and the injection filling tube 2122 are drawn to the interface 213 , respectively, a reinforcing tube 215 is fixed, and a plurality of circular grooves C are arranged in the middle end area of the reinforcing tube 215. As shown in FIG. The middle section area is used for fixedly connecting the injection tube 212; the proximal area of the reinforcing tube 215 is provided with a plurality of grooves D, as shown in FIG. The proximal end region of the reinforcing tube 215 is used to improve the fracture resistance of the injection tube 212 , and a layer of flexible tube 216 is coated on the proximal end region of the reinforcing tube 215 to completely cover the groove D.

Embodiment 8:

As shown in FIGS. 31-32 , this embodiment is based on Embodiment 1. The difference between this embodiment and Embodiment 1 is that: (1) the bending control member 22133 is a bending control wire axially laid in the wall of the outer tube 2211 ; (2) The suction cavity 122 is composed of a separate pipe material; (3) The bend control handle 22134 and the outer pipe handle 2212 are not arranged axially.

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

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

The advantage of the design of the suction cavity 122 of the single tube is that the suction cavity 122 is composed of a fixed tube, the size of the cavity will not change with the change of the cavity volume between the outer tube and the injection tube, and the suction can be maintained. The suction efficiency is stable, and the design of the pipe can reduce the gap caused by the interconnection of each connecting piece, and enhance the suction efficiency of the stabilization device.

Embodiment 9:

As shown in FIG. 33 , this embodiment is based on Embodiment 1. The difference between this embodiment and Embodiment 1 is that the needle-exiting handle 222 shown includes a needle-exiting seat 2221 , a needle-extracting stroke control mechanism 2222 and a gripping portion. 2224, the needle outlet seat 2221 and the outer tube handle 2212 are axially limited or fixedly connected, and the needle outlet stroke control mechanism 2222 includes a push button 22224, a stroke controller 22225, a stroke controller fixture 22226 and a stroke guide rail 22227.

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

The specific embodiments of the present invention have been described above in detail, but they are only used as examples, and the present invention is not limited to the specific embodiments described above. 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, equivalent changes and modifications made without departing from the spirit and scope of the present invention should be included within the scope of the present invention.

Claims

A myocardial filling system, comprising a stabilization device (1), an injection device (2), a guide device (3) and a filler (4); wherein the stabilization device (1) at least comprises an adaptive device, the adaptive The device is fixedly arranged at the distal end of the myocardial filling system, the self-adapting device has a morphological self-adaptive structure, and when the self-adapting device is attached to the surface of the myocardial tissue, the myocardial filling system on the myocardial tissue The relative position is limited;

The injection device (2) at least includes an injection assembly (21), the injection assembly (21) includes an injection needle (211), an injection tube (212) and an injection control device (217), and the filler (4) is The injection assembly (21) realizes the controllable injection into the myocardial tissue;

The guide device (3) is fixedly arranged at the distal end region of the myocardial filling system and is located in the adaptive device, and the guide device is provided with an injection needle that forms a sliding fit with the injection needle (211). The guide hole (31) realizes the positioning and needle ejection functions of the injection needle (211) on the myocardial tissue.
The myocardial filling system according to claim 1, wherein the stabilization device (1) comprises a negative pressure suction device (12), and the negative pressure suction device (12) comprises a suction power source (121), A suction cavity (122), the suction power source (121) is located outside the myocardial filling system, the guide device (3) is provided with an adsorption hole (32), and the adaptive device is connected to the adsorption hole (32) The suction chamber (122) and the suction power source (121) form gas communication to realize the negative pressure suction function.
The myocardial filling system according to claim 1, wherein the injection device (2) comprises an injection control mechanism (22) comprising an outer tube assembly (221) and a needle exit handle (222) , the outer tube assembly includes an outer tube (2211), an outer tube handle (2212) and a bending control mechanism (2213), the outer tube handle (2212) is fixedly arranged at the proximal end of the outer tube (2211), so The injection assembly (21) penetrates the outer tube assembly (221), and the needle out handle (222) is arranged on the injection tube (211).
The myocardial filling system according to claims 1-3, wherein the injection needle has two forms, and when the needle tip of the injection needle (211) is located in the injection needle guide hole, it has a linear first form , after the injection needle (211) protrudes out of the injection needle guide hole, it has a second curved arc shape; the injection needle guide hole (31) on the guide device (3) ensures the injection The second configuration of the needle remains relatively stationary with respect to the myocardial filling system.
The myocardial filling system according to claim 1, wherein the adaptive device (11) of the stabilization device (1) is a corrugated structure, and the corrugated structure comprises an annular texture, an arc texture, and a strip texture. One or more kinds; wherein, the annular texture and/or arc-shaped texture is distributed on the stabilization device (1) in a ring shape along the circumferential direction of the stabilization device, so that the stabilization device (1) is in the axial direction upwardly compressible resilience; the strip-shaped texture is distributed in the distal region of the stabilization device (1) in a direction inclined towards the distal end, so that the distal portion of the stabilization device (1) is radially It has a resiliency that can be expanded to expand; or the adaptive device is directly made of a material with resiliency.
The myocardial filling system according to claim 4, wherein 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 segment (22132), a bend control piece (22133) and the bend control handle (22134); wherein the bendable segment (22132) is located at the distal end region of the outer tube (2211), and the bendable segment (22132) is located at the distal end of the outer tube (2211). The bending section (22132) partially or completely covers the adaptive bending structure in the axial direction; the distal end of the bending control member (22133) is fixed to the outer tube (2211) through the distal fixing member (22131) connection; the bend control handle (22134) includes a bend control operation part (221342), a bend control control part (221343) and a bend control seat (221341), and the proximal end of the bend control part (22133) is connected to the bend control part (221333). The control part (221343) is connected; the bending control operation part (221342) is operated, and the bending control control part (221343) drives the bending control part (22133) to move axially, so as to realize the connection of the distal part of the myocardial filling system. Bending; the bending control member (22133) is a bending control wire axially laid in the wall of the outer tube (2211) or outside the outer tube (2211), or the bending control member (22133) is a sleeve Control bend tube within the outer tube (2211).
The myocardial filling system according to claim 6, wherein the bend control member (22133) is a bend control tube sleeved in the outer tube (2211), and the outer tube (2211) is connected to the bend control tube. The tubes are coaxially slidably fitted, the bendable section (22132) of the outer tube (2211) is a plurality of hollow structures A, the hollow structures A are narrow strip-shaped through grooves, the plurality of hollow structures A are parallel to each other, and Surrounded on the outer tube (2211); in the bendable section (22132) of the outer tube (2211), the control bend tube is provided with a plurality of hollow structures B, and the hollow structures B are narrow strips A plurality of hollow structures B are parallel to each other and surround the control elbow, and a plurality of hollow structures A and a plurality of hollow structures B are partially or completely overlapped in the axial direction, but are located on two sides of the pipe wall. side.
The myocardial filling system according to claim 7, wherein the outside of the area of the bendable segment (22132) of the outer tube (2211) is hermetically wrapped with a synchronously bendable segment (22132). Outer pipe seal (2214); a control bend pipe seal (22135) is fixedly connected in the outer pipe handle (2212), and the bend control pipe (22133) passes through the control bend pipe 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 (212) passes through the injection tube seal (214) and the two Forming a sliding seal fit; the outer tube seal (2214), the elbow control tube seal (22135) and the syringe seal (214), with the syringe (212) and the outer tube ( 2211) to form the suction cavity (122), the suction hole (32), the suction cavity (122) and the outer tube handle through hole provided in the outer tube handle (2212) (22121) forms a suction channel.
The myocardial filling system of claim 8, wherein the bend control tube (22133) is located between the distal end of the bend control tube seal (22135) and the proximal end of the outer tube (2211) A control elbow through hole (221331) is provided on it, and the suction channel includes the control elbow through hole (221331), so that the outer tube handle through hole (22121) and the adsorption hole (32) pass through the control elbow (22121). The through hole of the elbow (221331) realizes gas communication.
The myocardial filling system according to claim 1, wherein the outer surface of the injection tube (212) is fixedly provided with partial raised structures, which are integrally designed with the injection tube (212), and the raised structures are dotted distributed in a shape of a strip or in a strip shape, so that the injection tube (212) and the outer tube (2211) form a coaxial sliding fit.
The myocardial filling system according to claim 3, wherein the needle withdrawal handle (222) comprises a needle withdrawal seat (2221), a needle withdrawal stroke control mechanism (2222) and/or a needle withdrawal limit control mechanism (2223); Wherein, the needle outlet seat (2221) is axially limited or fixedly connected with the outer tube handle (2212) or the bending control mechanism (2213); the needle outlet stroke control mechanism (2222) realizes the The stroke of the injection needle (211) extending out of the guide device (3) is controlled; the needle exit limit control mechanism (2223) defines the maximum stroke of the injection needle (211) extending out of the guide device (3).
The myocardial filling system according to claim 11, wherein the needle exit stroke control mechanism (2222) comprises a stroke control member (22221) and a stroke control operation part (22222), and the stroke control member (22221) is connected with the stroke control member (22221). The injection tube (212) is connected to a limit or fixedly connected, and the stroke control operation part (22222) is operated, so that the injection needle (211) is protruded in a stepwise or continuous manner relative to the guide device (3), so as to realize The stroke control of the injection needle (211) extending out of the guide device (3); the needle exit limit control mechanism (2223) includes a limit control member (22231) and a limit control operation part (22232), the limit The position control member (22231) realizes axial sliding relative to the needle outlet seat (2221), so that the limit control member (22231) can abut against the stroke control member (22221), and the needle outlet limit control The mechanism (2223) defines the maximum travel of the injection needle (211) out of the guide (3).
The myocardial filling system according to claim 12, wherein the bending control mechanism (2213) is provided with a bending control angle mark, or the needle exit handle (222) is provided with a needle exit scale mark that is convenient for the operator to observe , the needle outlet scale mark includes a scale line (22211), a stroke pointer (22223) and/or a limit pointer (22233), the scale mark (22211) is located on the needle outlet seat (2221), and the stroke pointer ( 22223) is fixedly arranged on the travel control member (22221), and the limit pointer (22233) is fixedly arranged on the limit control member (22231).
The myocardial filling system according to claim 1, wherein a filter structure (23) is fixedly arranged at the distal end of the guide device (3), and the filter structure (23) has one or more micropores, so that the gas can pass from The micropores pass through, and the liquid cannot pass through the micropores.
The myocardial filling system according to claim 1, wherein a monitoring mechanism (24) is provided in the distal region of the myocardial filling system, and the monitoring mechanism (24) is arranged to penetrate through the outer tube (2211) and the control device. The viewing window (241) of the pipe wall of the bent pipe (22133), or the monitoring mechanism (24) is an observation part (242) made of a light-transmitting material, and the observation part (242) is the Part or all of the injection tube (212), the outer tube (2211), the elbow control tube (22133), the outer tube seal (2214) and/or the adaptive device (11).