Implanting instrument suitable for heart valve reflux disease and implanting method thereof

Abstract

The invention discloses an implantation instrument suitable for heart valve regurgitation and an implantation method of the implantation instrument, and relates to the field of medical instruments. The whole implantation device is based on a balloon catheter structure, the barb hook part convenient to detach and separate is arranged at the front end of the catheter, the barb hook part can be in a folded state or an unfolded state according to different stress states, and when the barb hook part is in the folded state, the whole implantation device can be implanted into a heart and a great blood vessel through a vein blood vessel and a conveying sheathing canal in an interventional mode; the operation is simple and convenient, and the wound is extremely small. Besides, compared with implants in the market, the balloon catheter has the advantages that the heart valve of the balloon catheter does not need to be repaired, only the balloon filled with air or liquid needs to be arranged at the position of the regurgitation heart valve, the regurgitation heart valve opening can be partially blocked after the balloon is filled, the area of the heart valve opening is reduced, and the balloon catheter is convenient to use. And when the balloon is filled, the acting point position is direct and clear, and the treatment effect is exact.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices and relates to a therapeutic device for heart valve regurgitation, and in particular to an implantation device suitable for heart valve regurgitation and an implantation method thereof. Background Art

[0002] The heart has four valves that direct blood flow in the correct direction during the cardiac cycle. The valves ensure that blood does not flow back from the ventricles into the corresponding atria, or from the arteries into the corresponding ventricles. The mitral valve is located between the left atrium and the left ventricle and prevents blood from flowing back from the left ventricle into the left atrium during systole. The tricuspid valve is located between the right atrium and the right ventricle and prevents blood from flowing back from the right ventricle into the right atrium during systole. Mitral and tricuspid regurgitation are the most common valvular heart diseases and can lead to decreased heart pumping ability, systolic failure, and even life-threatening conditions.

[0003] Severe mitral or tricuspid regurgitation requires surgical intervention, but elderly or high-risk patients may not be able to tolerate surgery. In recent years, minimally invasive transcatheter mitral or tricuspid valve interventional treatment has emerged.

[0004] The main surgical interventional treatments for transcatheter mitral regurgitation are transcatheter mitral valve clamping and transcatheter mitral valve replacement. Transcatheter mitral valve clamping is only suitable for secondary mitral regurgitation caused by mitral annular dilatation, also known as functional mitral regurgitation. It is not effective for organic mitral regurgitation caused by damage to the annulus, leaflets, or chordae, also known as primary mitral regurgitation. The mitral valve area is complex, and transcatheter mitral valve replacement currently suffers from high postoperative mortality and uncertain efficacy, preventing large-scale clinical application.

[0005] The main surgical interventions for transcatheter tricuspid regurgitation include transcatheter tricuspid valve clamping and transcatheter tricuspid valve replacement. However, both treatments have drawbacks. Transcatheter tricuspid valve clamping is complex and has high uncertainty about its effectiveness. Transcatheter tricuspid valve replacement involves implanting a prosthetic tricuspid valve. However, due to the slow blood flow in the tricuspid valve region, which is prone to thrombosis, postoperative anticoagulation is a concern.

[0006] Therefore, there is no interventional treatment device in clinical practice that can treat mitral or tricuspid regurgitation with simple operation and accurate effect. Summary of the Invention

[0007] The purpose of the present invention is to provide an implantable device suitable for heart valve regurgitation and its implantation method, which can reduce mitral valve regurgitation or tricuspid valve regurgitation by implanting into the heart, and has simple operation and definite effect, and can solve the problems existing in the above-mentioned prior art.

[0008] To achieve the above object, the present invention provides the following solutions:

[0009] The present invention provides an implantable device suitable for treating heart valve regurgitation, comprising a catheter, a balloon, a balloon expandable and contractible portion, and a barbed hook portion, wherein:

[0010] The balloon is arranged at the middle front part of the catheter, and a channel communicating with the balloon is arranged in the catheter;

[0011] The balloon expansion and contraction part is arranged at the tail end of the catheter and is connected to the hole. The balloon expansion and contraction part can fill or absorb liquid or gas into the balloon through the hole to make the balloon inflated or deflated;

[0012] The barb hook part includes a connecting body and a barb hook. One end of the connecting body is detachably connected to the front end of the catheter through a detachable connecting part. The connecting body is provided with the barb hook facing the catheter, and the barb hook can be in a retracted state when subjected to external force, and automatically restore to an open state after the external force disappears.

[0013] Preferably, the detachable connection portion is a threaded connection structure.

[0014] Preferably, an end portion of the connecting body connected to the conduit is provided with an external thread, and a front end of the conduit is provided with an internal thread hole adapted to the external thread.

[0015] Preferably, the catheter is a hollow catheter, and its internal cavity serves as the channel. A through opening is provided on the side wall of the catheter to connect the interior of the balloon and the internal cavity of the catheter; the internal cavity of the catheter is spaced from the front end of the catheter.

[0016] Preferably, the tail end of the catheter is provided with a tail end interface communicated with the channel; the balloon expansion and contraction part includes a sealed soft valve, which is provided in the tail end interface.

[0017] Preferably, the balloon expandable and contractible portion further includes a plug, and the plug is detachably connected to the tail end interface.

[0018] Preferably, the plug is a nut threadedly connected to the tail end interface.

[0019] Preferably, the barbed hook is a nickel-titanium alloy barbed hook.

[0020] Preferably, a plurality of the barbed hooks are evenly distributed along the circumferential direction on the outside of the connecting body.

[0021] The present invention further provides a method for implanting any of the above-mentioned implantable devices for treating heart valve regurgitation, comprising:

[0022] Inserting a guide wire into the right ventricle or the left ventricle, and inserting a delivery sheath along the guide wire until the front end of the delivery sheath is in close contact with the right ventricular septum or the left ventricular apex;

[0023] The catheter is inserted into the delivery sheath and delivered to the right ventricular septum or the left ventricular apex through the delivery sheath until the barbed hook portion at the front end of the catheter extends out of the front end of the delivery sheath and the barbed hook automatically opens, thereby hooking the ventricular trabeculae with the barbed hook and anchoring the front end of the catheter in the myocardial trabeculae of the right ventricular septum or the left ventricular apex;

[0024] withdrawing the delivery sheath;

[0025] Inflating the catheter with gas or liquid to inflate and expand the balloon at the heart valve site;

[0026] Suture the dedicated fixing device together with the tail end of the catheter, and bury it subcutaneously in the left or right chest for fixation;

[0027] When a new implant device needs to be replaced, the balloon is deflated and the catheter is rotated to separate the front end of the catheter from the connecting body, and then the catheter is pulled out, with the barbed hook portion remaining in the heart.

[0028] Compared with the prior art, the present invention has achieved the following technical effects:

[0029] The implantable device for valvular regurgitation proposed by the present invention is based on a balloon catheter structure as a whole, and the front end of the catheter is configured with a barbed hook portion that is easy to disassemble and detach. The barbed hook portion can be in a retracted state or an open state according to the stress state. In the retracted state, the entire implantable device can be implanted into the heart and large blood vessels through a delivery sheath through a venous blood vessel in an interventional manner, which is not only simple to operate but also minimally invasive. The present invention can be used to treat mitral regurgitation or tricuspid regurgitation, and the biggest difference between the balloon catheter of the present invention and various interventional implants on the market is that it does not require repair of the mitral or tricuspid valve itself. It only requires an inflated or liquid-filled balloon to be inserted into the regurgitant mitral or tricuspid valve. After the balloon is inflated, it can partially block the regurgitant mitral or tricuspid valve orifice, reducing the area of the mitral or tricuspid valve orifice, thereby achieving the purpose of reducing mitral or tricuspid regurgitation. The operation is simple and the treatment effect is definite.

[0030] The implantation method of the implant device suitable for heart valve regurgitation proposed in the present invention is simple to operate. It only requires inserting an air-filled or liquid-filled balloon into the regurgitant mitral valve or tricuspid valve. After the balloon is inflated, it can partially block the regurgitant mitral valve orifice or tricuspid valve, reducing the area of the mitral valve orifice or tricuspid valve, thereby achieving the purpose of reducing mitral valve or tricuspid valve regurgitation. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0032] Figure 1 This is a schematic diagram of the overall structure of an implantable device for heart valve regurgitation disclosed in an embodiment of the present invention (the balloon is not inflated);

[0033] Figure 2 This is a schematic structural diagram of the balloon of the implant device disclosed in an embodiment of the present invention when it is in a filled state;

[0034] Figure 3 This is a schematic diagram of the structure of the catheter tail end and the nut of the implant device disclosed in an embodiment of the present invention after being tightened;

[0035] Figure 4 This is a schematic diagram of a delivery sheath disclosed in an embodiment of the present invention being delivered to the apex or septum of the right ventricle via the subclavian vein or axillary vein;

[0036] Figure 5 This is a schematic diagram of an implantable device disclosed in an embodiment of the present invention being delivered to the right ventricular septum via a delivery sheath;

[0037] Figure 6 This is a schematic diagram of withdrawing the delivery sheath and retaining the implanted device in the heart according to an embodiment of the present invention;

[0038] Figure 7 This is a schematic diagram of the balloon disclosed in an embodiment of the present invention being inflated and expanded at the tricuspid valve orifice;

[0039] Figure 8 This is a partial enlarged view of the front end of the catheter after the implant device disclosed in the embodiment of the present invention is implanted;

[0040] Figure 9 This is a schematic diagram of the embodiment of the present invention when the catheter is rotated to separate from the front end barbed hook portion;

[0041] Figure 10 This is a schematic diagram of the catheter and balloon according to an embodiment of the present invention being withdrawn while retaining the barbed hook portion in the heart;

[0042] Figure 11 This is a schematic diagram of an Nth (N is a positive integer not less than 2) barbed hook portion implanted into the heart according to an embodiment of the present invention;

[0043] Figure 12This is a schematic diagram of filling the balloon disclosed in an embodiment of the present invention and expanding the balloon at the mitral valve orifice.

[0044] In the figure, the accompanying drawings are marked as follows:

[0045] 100. Implantable devices for heart valve regurgitation;

[0046] 1. Catheter;

[0047] 2. Balloon;

[0048] 3. Barb hook part; 31. Connecting body; 32. Barb hook;

[0049] 4. Tail end interface;

[0050] 5. Soft valve;

[0051] 6. Nut;

[0052] 7. Detachable connection part;

[0053] 8. Delivery sheath. DETAILED DESCRIPTION

[0054] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0055] The purpose of the present invention is to provide an implantable device suitable for heart valve regurgitation and an implantation method thereof, which can treat mitral valve regurgitation, tricuspid valve regurgitation, etc., and has simple operation and definite effect, so as to solve the problems existing in the prior art.

[0056] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0057] Example 1

[0058] like Figures 1 to 3As shown, this embodiment provides an implantable device 100 for treating valvular regurgitation. The device can be implanted in a ventricle of the heart to treat mitral and / or tricuspid regurgitation. The implantable device is a balloon catheter structure, specifically comprising a catheter 1, a balloon 2, a balloon expansion and contraction portion capable of controlling the expansion and contraction of the balloon 2, and a barbed hook portion 3 for anchoring the front end (also referred to as the "distal end") of the catheter 1. The barbed hook portion 3 includes a connecting body 31, one end of which is threadedly connected to the front end of the catheter 1, thereby forming a detachable connection portion 7 between the connecting body 31 and the front end of the catheter 1, which is convenient for detaching from the front end of the catheter 1 after implantation. The end of the connecting body 31 away from the front end of the catheter 1 is provided with a barbed hook 32 facing the catheter 1, and the barbed hook 32 can be bent by external force and attached to the outside of the connecting body 31, at which time the barbed hook 32 is in a compressed and retracted state. At the same time, the barbed hook 32 can automatically expand to the outside of the connecting body 31 and take on a hook shape after the external force disappears, at which time the barbed hook 32 is in its original open state. The balloon 2 is arranged in the middle front part of the catheter 1 (i.e., near the front end of the catheter), and the balloon 2 is evenly distributed around the outer periphery of the catheter 1. A channel is provided in the catheter 1, the first end of the channel is connected to the balloon 2, and the second end of the channel is located at the tail end (also known as the "proximal end") of the catheter 1. The balloon's expandable and contracting portion is disposed at the rear end of the catheter 1 and communicates with the second end of the orifice. The balloon's expandable and contracting portion can fill or absorb liquid or gas into the balloon 2 through the orifice, thereby causing the balloon 2 to fill and expand toward the periphery of the catheter 1, or to contract and deflate toward the catheter 1. The above-mentioned implantable device 100 for valvular regurgitation adopts a balloon catheter structure as a whole, which can be implanted into the heart ventricle with the aid of a delivery sheath 8 or the like. After implantation, the barb hooks 32 of the barb hook portion 3 are released through the delivery sheath 8, and the barb hooks 32 are used to hook and fix the barb hooks in the myocardial trabeculae of the ventricular apex or septum. The delivery sheath 8 is then withdrawn, and the balloon 2 is inflated with gas or liquid using the balloon's expandable and contracting portion, thereby causing the balloon 2 to expand at the mitral or tricuspid valve orifice, effectively reducing mitral or tricuspid regurgitation.

[0059] The implantable device 100 for valvular regurgitation can treat mitral and tricuspid regurgitation, effectively reducing mitral or tricuspid regurgitation without affecting normal blood flow within the heart. The device also features a simple structure, low manufacturing cost, easy implantation, and excellent therapeutic efficacy. Compared to mitral or tricuspid valve replacement surgery, the main structure of the implantable device in this embodiment, with the exception of the barbed hook portion 3, is essentially removed from the body after surgery, making it extremely safe and preventing the risk of postoperative thrombosis.

[0060] In some embodiments, the end of the connecting body 31 connected to the catheter 1 is preferably provided with an external thread, and the front end of the catheter 1 is provided with an internal thread hole adapted thereto, thereby achieving a threaded detachable connection between the two.

[0061] In some embodiments, catheter 1 is preferably a hollow catheter, with its internal cavity serving as the aforementioned passageway connecting balloon 2 and the balloon's expandable and contractible portion. Balloon 2 is a pre-made component that is typically inserted over the exterior of catheter 1 and secured by bonding or other means. Meanwhile, a through-hole is defined in the sidewall of catheter 1, connecting both the interior of balloon 2 and the cavity of catheter 1. It should be noted that the internal cavity of catheter 1 is not connected to the front end of catheter 1 to ensure the airtightness of balloon 2.

[0062] In some embodiments, the balloon 2 may be made of plastic or rubber, and may be coated with a super-slip coating to prevent damage to the tricuspid valve due to repeated friction with the tricuspid valve.

[0063] In some embodiments, the surface of the catheter 1 is preferably coated with an ultra-slip coating, generally a hydrophilic polymer such as polyvinylpyrrolidone (PVP), etc. This facilitates delivery into the heart through the delivery sheath 8 while avoiding friction damage between the catheter and the heart tissue.

[0064] In some embodiments, the cavity of the catheter 1 is connected to its tail end, and forms a tail end interface 4. The tail end interface 4 is provided with a sealed soft valve 5. The soft valve 5 is in a closed state, and a special needle can be used to pass through the soft valve 5 to inflate or fill the balloon 2 with air or liquid. After the needle is pulled out, the soft valve 5 is still in a closed state, which can prevent the inflated balloon 2 from leaking and keep the balloon 2 in a filled state. Correspondingly, when it is necessary to deflate or drain the balloon 2, the soft valve 5 can also be inserted through the above-mentioned special needle. At this time, the needle body is connected to an air pump or a liquid pump to achieve the deflation of the balloon 2, and then the needle can be pulled out. The soft valve 5 is a rubber structure as a whole. After the needle is pulled out, the needle hole can be closed under the elastic contraction function of the rubber material without leaking.

[0065] In some embodiments, to ensure airtightness of the catheter 1, a specially adapted nut 6 is provided at the end of the catheter 1. This nut 6 is threadedly connected to the end interface 4 of the catheter 1 to seal the end of the catheter, ensuring airtightness. In this case, a soft valve 5 is located within the catheter 1. By removing the nut 6, the balloon 2 can be inflated, filled, deflated, or drained through the soft valve 5.

[0066] In some embodiments, Figures 1 to 3 and Figure 8 As shown, the end of the connecting body 31 away from the front end of the catheter 1 is preferably evenly spaced along the circumference with multiple barbed hooks 32, including but not limited to four, five, or six barbed hooks 32. When in the initial open state, the barbed hooks 32 have a gently rounded arc shape, which can avoid damaging cardiac tissue.

[0067] In some embodiments, each barb 32 and the connecting body 31 are preferably made of nickel-titanium alloy, and the barb 32 and the connecting body 31 are preferably integrally formed. Nickel-titanium alloy can impart elasticity and shape memory to the barb 32, allowing the barb 32 to bend, retract, and automatically reset. The barb 32 can remain automatically open in the absence of external force, and can be retracted into the delivery sheath 8 when bent by external force, thereby facilitating the overall delivery of the implantable device.

[0068] In some embodiments, the catheter 1 is preferably a relatively soft structure, including but not limited to polyethylene material, so that the catheter 1 has a certain supporting force and a certain anti-bending function, and can be bent without deformation.

[0069] The implantable device 100 for treating heart valve regurgitation is suitable for treating mitral valve regurgitation and tricuspid valve regurgitation.

[0070] The following uses the treatment of tricuspid regurgitation as an example to specifically explain how to use the implantable device.

[0071] During use, the catheter can be implanted into the heart through the axillary vein or subclavian vein. The multiple barbed hooks 32 at the front end of the catheter 1 can hook onto the muscle trabeculae of the right ventricular apex or right ventricular septum, thereby fixing the front end of the catheter 1. Then, the balloon 2 is inflated with air or liquid to expand the balloon 2 at the tricuspid valve. After the balloon 2 is inflated, the tail end of the catheter 1 can be buried under the skin of the left or right chest and fixed. Figures 4 to 11 The specific process of implanting the above-mentioned implant device 100 for heart valve regurgitation into the heart is as follows:

[0072] The first step is to puncture the axillary vein or subclavian vein and insert the guide wire into the right ventricle. Insert a flexible (at least distally flexible) delivery sheath 8 (such as a left atrial appendage occluder delivery sheath or an adjustable bend sheath for electrophysiology) along the guide wire, and place the front end of the delivery sheath 8 close to the right ventricular apex or right ventricular septum, such as Figure 4 In actual applications, the sheath size can be determined according to the size of the balloon catheter, including diameter grades ranging from 6F to 10F. For example, when using a catheter 1 with a diameter of 10mm, a 6F delivery sheath is required, and when using a catheter 1 with a diameter of 20mm, a 10F delivery sheath is required.

[0073] The second step is to insert the catheter 1 with the barbed hook part 3 at the front end (with the balloon 2 provided thereon and the balloon 2 is in a deflated state) into the delivery sheath 8 and deliver it to the right ventricular apex or right ventricular septum through the delivery sheath 8. Figure 5When the front end of the catheter 1 approaches the front end of the delivery sheath 8, the delivery sheath 8 is pushed forward slightly with force, so that the front end of the delivery sheath 8 gently presses against the right ventricular apex or right ventricular septum. At this time, the catheter 1 is pushed forward, so that the barb hooks 32 of the front end barb hook portion 3 extend out of the front end of the delivery sheath 8 and automatically open, so that the barb hooks 32 can hook the myocardial trabeculae of the right ventricular apex or septum, anchoring the front end of the catheter 1 in the myocardial trabeculae of the right ventricular apex or septum. At this time, the balloon 2 is located at the tricuspid valve.

[0074] The third step is to withdraw the delivery sheath 8. Figure 6 As shown, the balloon catheter remains in the heart. Figure 7 As shown, the nut 6 is removed, and the soft valve 5 is used to inflate air or liquid into the catheter 1 to fill and expand the balloon 2 at the tricuspid valve site to reduce the valve area, thereby reducing the regurgitation volume of the tricuspid valve.

[0075] Step 4: After the balloon 2 is fully inflated, the nut 6 is installed to completely seal the tail end of the catheter 1 to prevent air leakage.

[0076] Step 5: A dedicated balloon catheter fixation device (commonly known as a "flying head," similar to the device used to secure the pacing lead after implantation) is sutured to the tail of catheter 1 and embedded subcutaneously in the left or right chest. Finally, the skin is sutured to complete the procedure.

[0077] When the implant device 100 for heart valve regurgitation is implanted for several years and the balloon 2 is leaking or aging, and a new implant device is needed, the skin is partially cut, the fixing device is loosened, and the balloon 2 is deflated. By rotating the catheter 1, the front end of the catheter 1 can be separated from the connecting body 31. Figure 9 Then the catheter 1 with the balloon 2 is pulled out, and the barbed hook portion 3 remains in the heart, as shown. Figure 10 Because the device of this solution is implanted in the heart for more than half a year, the barbed hook 32 at the front end will be firmly adhered to the myocardial tissue and cannot be pulled out.

[0078] After the catheter 1 is removed, a new implantable device 100 suitable for valvular regurgitation can be implanted as needed. The steps are basically the same as before. The difference is that one of the following two methods can be used as needed:

[0079] (1) If Figure 11 As shown, a complete implantable device 100 for tricuspid regurgitation is reimplanted. However, when anchoring the distal end of the catheter 1 via the barbed hook portion 3, another myocardium in the right ventricular apex or septum is selected. In this manner, the balloon 2 is inflated to restore the tricuspid regurgitation function.

[0080] (2) If the old barbed hook portion 3 remaining in the ventricle still has use value, the newly implanted implantable device 100 for valvular regurgitation can be removed with the barbed hook portion 3 removed. After the new catheter 1 is inserted into the heart, it can be directly positioned with the old barbed hook portion 3 remaining in the ventricle. Then, by rotating the catheter 1 in the opposite direction, the catheter 1 and the connecting body 31 in the barbed hook portion 3 are threadedly connected. At this point, the old barbed hook portion 3 has essentially the same fixing effect on the catheter 1 as the new one. In this manner, after the balloon 2 is inflated, the function of reducing tricuspid regurgitation can be restored.

[0081] As we all know, percutaneous tricuspid valve replacement is difficult to apply clinically. The main reason is that the tricuspid valve is a complex structure, not a fixed ring structure. The artificial valve stent cannot be fixed after implantation. Therefore, clinical percutaneous interventional treatment of tricuspid valve is usually to improve tricuspid regurgitation through methods such as clamping. The disadvantages of clamping are that the effect is not very good and the operation is complicated.

[0082] The implant device 100 of this solution, which is suitable for treating valvular regurgitation, is based on a balloon catheter structure as a whole, and the front end of the catheter is provided with a barbed hook portion that is easy to disassemble and detach. The barbed hook portion can be in a folded state or an open state according to the stress state. In the folded state, the entire implant device can be implanted into the heart and large blood vessels through the veins and the delivery sheath in an interventional manner. It is not only easy to operate but also minimally invasive. In addition, the biggest difference between the balloon catheter of this solution and the implants on the market is that it does not require the repair of the tricuspid valve itself. It only requires an air-filled or liquid-filled balloon to be inserted into the regurgitant tricuspid valve. After the balloon is filled, it can partially block the regurgitant tricuspid valve orifice, reduce the area of the tricuspid valve orifice, and thus achieve the purpose of reducing tricuspid valve regurgitation. The balloon filling operation is simple and the treatment effect is definite. The length of the balloon varies from 20mm to 30mm, and the diameter after inflation varies from 10mm to 30mm. Balloons of different sizes can be selected according to the amount of reflux to cover the part of the tricuspid valve orifice that is regurgitating, thereby reducing the reflux.

[0083] After several years of implantation, the filled balloon may age or deflate due to various reasons. In this case, a new balloon catheter can be replaced. Considering that the barbed hook portion is fixed to the ventricular myocardial trabeculae after endothelialization and cannot be removed, the barbed hook portion is connected to the front end of the catheter 1 via a threaded connection structure that is easy to disassemble and separate. By rotating the catheter 1, the catheter 1 can be loosened, separating the catheter 1 from the barbed hook portion. The implanted device, excluding the barbs, can then be removed from the body. This makes replacement very simple.

[0084] The principle of using the implantable device 100 for heart valve regurgitation to implant in the heart to treat mitral valve regurgitation is basically the same as the above-mentioned scheme for treating tricuspid valve regurgitation. However, the implantation method is different, such as Figure 12 As shown:

[0085] First, puncture the atrial septum, send in guide wire and delivery sheath 8 to the left ventricle. Send the above-mentioned implantation device 100 that is applicable to valvular regurgitation to the left ventricle apex through delivery sheath 8, advance catheter 1 forward, make the barb hook 32 of its front end barb hook part 3 stretch out the front end outside of delivery sheath 8, and automatically open, thereby can utilize barb hook 32 to hook the muscle trabeculae of left ventricle apex, catheter 1 front end is anchored in the left ventricle, and this moment, sacculus 2 is positioned at mitral valve position. Delivery sheath 8 is withdrawn, and balloon catheter is retained in the heart. Remove nut 6 then, utilize soft valve 5 to inflate or fill with liquid in catheter 1 to make sacculus 2 fill and expand at mitral valve position, to reduce valve area, thereby reduce the regurgitation amount of mitral valve.

[0086] It should be noted that the structures, proportions, sizes, etc. depicted in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the conditions for the implementation of the present invention. Therefore, they have no substantial technical significance. Any modification of the structure, change in the proportional relationship or adjustment of the size should still fall within the scope of the technical content disclosed by the present invention without affecting the efficacy and purpose of the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description and are not used to limit the scope of the implementation of the present invention. Changes or adjustments in their relative relationships should also be regarded as the scope of the implementation of the present invention without substantially changing the technical content.

[0087] The present invention uses specific examples to illustrate the principles and implementation methods of the present invention. The above examples are only intended to help understand the method and core concept of the present invention. At the same time, those skilled in the art will find that the specific implementation methods and application scopes may vary based on the concept of the present invention. In summary, the contents of this specification should not be construed as limiting the present invention.

Claims

1. An implantable device for treating heart valve regurgitation, characterized in that: The invention comprises a catheter, a balloon, a balloon expansion and contraction part and a barbed hook part, wherein: The balloon is arranged at the middle front part of the catheter, and a channel communicating with the balloon is arranged in the catheter; The balloon expansion and contraction part is arranged at the tail end of the catheter and is connected to the hole. The balloon expansion and contraction part can fill or absorb liquid or gas into the balloon through the hole to make the balloon inflated or deflated; The barb hook part includes a connecting body and a barb hook. One end of the connecting body is detachably connected to the front end of the catheter through a detachable connecting part. The connecting body is provided with the barb hook facing the catheter, and the barb hook can be in a retracted state when subjected to external force, and automatically restore to an open state after the external force disappears.

2. The implantable device for heart valve regurgitation according to claim 1, characterized in that: The detachable connection portion is a threaded connection structure.

3. The implantable device for heart valve regurgitation according to claim 2, characterized in that: An end portion of the connecting body connected to the conduit is provided with an external thread, and a front end of the conduit is provided with an internal thread hole adapted to the external thread.

4. The implantable device for heart valve regurgitation according to any one of claims 1 to 3, characterized in that: The catheter is a hollow catheter, and its internal cavity serves as the channel. A through hole is opened on the side wall of the catheter to connect the interior of the balloon and the internal cavity of the catheter; the internal cavity of the catheter is spaced from the front end of the catheter.

5. The implantable device for heart valve regurgitation according to claim 4, characterized in that: The tail end of the catheter is provided with a tail end interface communicated with the channel; the balloon expansion and contraction part includes a sealed soft valve, which is arranged in the tail end interface.

6. The implantable device for heart valve regurgitation according to claim 5, characterized in that: The balloon expansion and contraction part also includes a plug, and the plug is detachably connected to the tail end interface.

7. The implantable device for heart valve regurgitation according to claim 6, characterized in that: The plug is a nut threadedly connected to the tail end interface.

8. The implantable device for heart valve regurgitation according to any one of claims 1 to 3, characterized in that: The barbed hook is a nickel-titanium alloy barbed hook.

9. The implantable device for heart valve regurgitation according to any one of claims 1 to 3, characterized in that: The outside of the connecting body is evenly distributed with a plurality of barbed hooks along the circumferential direction.

10. A method for implanting the implant device for heart valve regurgitation according to any one of claims 1 to 9, characterized in that: include: Inserting a guide wire into the right ventricle or the left ventricle, and inserting a delivery sheath along the guide wire until the front end of the delivery sheath is in close contact with the right ventricular septum or the left ventricular apex; The catheter is inserted into the delivery sheath and delivered to the right ventricular septum or the left ventricular apex through the delivery sheath until the barbed hook portion at the front end of the catheter extends out of the front end of the delivery sheath and the barbed hook automatically opens, thereby hooking the ventricular trabeculae with the barbed hook and anchoring the front end of the catheter in the myocardial trabeculae of the right ventricular septum or the left ventricular apex; withdrawing the delivery sheath; Inflating the catheter with gas or liquid to inflate and expand the balloon at the heart valve site; Suture the dedicated fixing device together with the tail end of the catheter, and bury it subcutaneously in the left or right chest for fixation; When a new implant device needs to be replaced, the balloon is deflated and the catheter is rotated to separate the front end of the catheter from the connecting body, and then the catheter is pulled out, with the barbed hook portion remaining in the heart.

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