Implant and components for forming implant

Abstract

The present invention relates to the field of medical devices, and in particular to an implant and a component for forming the implant, wherein the implant comprises an artificial chord and a papillary muscle anchoring element, wherein the artificial chord comprises an artificial chord body and a self-tightening structure for anchoring the valve leaflets formed at one end of the artificial chord body, and the other end of the artificial chord body is connected to the papillary muscle anchoring element. The implant of the present invention optimizes the valve leaflet fixation method of the artificial chord prosthesis, and can complete the fixation of the artificial chord and the valve leaflet through interventional surgery, without the need for thoracotomy, with minimal surgical trauma and rapid patient recovery. The self-tightening knot will not shift, reducing the friction between the knot and the valve leaflet, resulting in a small anchoring wound, minimal damage to the native valve leaflet, good anchoring effect, and stable reflux treatment effect; at the same time, it is conducive to the rapid endothelialization of the implant, better endothelialization effect, and will not change the anatomical morphology of the valve leaflet.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, in particular to an implant and a component for forming the implant. Background Art

[0002] The mitral valve is a complex structure between the left atrium (LA) and left ventricle (LV), composed of the mitral annulus, the anterior and posterior mitral leaflets, the chordae tendineae, and the papillary muscles. The mitral valve ensures that blood flows only from the left atrium to the left ventricle and not in the opposite direction. A healthy mitral valve has multiple chordae tendineae, one end of which connects to the edge of the leaflets and the other end connects to the papillary muscles in the ventricular wall. When the left ventricle is in diastole, the anterior and posterior leaflets of the mitral valve open, and the chordae tendineae relax, allowing blood to flow from the left atrium to the left ventricle. During systole, the anterior and posterior leaflets of the mitral valve close under the pressure of blood. At the same time, the chordae tendineae prevent the leaflets from tilting to the atrial side due to blood pressure. The combined action of the leaflets and chordae tendineae closes the blood flow channel between the LA and LV, forcing blood to flow only from the left ventricle through the aortic valve (AV) to the aorta and to various organs throughout the body. When chordae tendineae or papillary muscles become diseased, or are impacted by external forces, they often cause some of the chordae tendineae to stretch or rupture. When the left ventricle contracts, the valve leaflets lose the traction of the chordae tendineae and flip to the side of the atrium under the action of blood pressure, causing the valve leaflets to be unable to close tightly, thereby causing blood reflux, i.e. mitral regurgitation. When acute severe mitral regurgitation occurs (such as rupture of chordae tendineae caused by external forces such as impact), hemodynamics changes dramatically, and a large amount of arterial blood flows back to the left atrium, causing pulmonary congestion, a sharp increase in capillary pressure, acute pulmonary edema, and severe clinical symptoms such as dyspnea and hemoptysis. If the patient does not receive immediate clinical intervention, it will lead to death. If only a few chordae tendineae rupture and cause mild to moderate mitral regurgitation, the patient will not immediately experience clinical symptoms due to the compensatory function of the heart. However, the increased tension of other chordae tendineae will cause new chordae tendineae rupture, and the increased left atrial pressure will cause the left atrium and mitral valve annulus to gradually expand, aggravating the degree of regurgitation, increasing the left ventricular preload, leading to left ventricular dilation and contraction dysfunction, and then left heart failure, and often leading to total heart failure, seriously endangering the patient's life and health. Chordae tendineae cannot repair themselves after they are diseased or ruptured. Even if a few chordae tendineae rupture, the tension of other chordae tendineae can increase, causing new chordae tendineae rupture. This shows that the elongation or rupture of mitral valve chordae tendineae has a great impact on human health and requires clinical intervention and treatment.

[0003] Mitral regurgitation caused by chordae tendineae lesions or chordae tendineae rupture can usually be treated with medication, surgery or interventional surgery. Medication (such as antihypertensive, diuretic, etc.) is symptomatic treatment, which can only alleviate clinical symptoms and cannot fundamentally solve the problem. For moderate to severe mitral regurgitation, cardiac surgery is still the gold standard for clinical treatment. Cardiac surgery requires general anesthesia to open the chest, and the operation is performed under direct vision with the help of extracorporeal circulation under cardiac arrest. The operation is complicated, the patient has a high risk of trauma and complications, and the hospitalization recovery time is long. It is not suitable for high-risk patients with poor cardiac function, multiple comorbidities, and advanced age.

[0004] Interventional surgery involves puncture, and under the guidance of modern imaging equipment such as three-dimensional ultrasound and angiography, the device is delivered to the heart through the peripheral blood vessels. The surgery is completed while the heart is beating, greatly reducing the degree of trauma and the risk of complications. It is the only treatment option for high-risk surgical patients. Interventional artificial chord repair devices generally consist of two parts: a delivery system and an implant. The implant includes artificial chords, leaflet anchoring elements, and papillary muscle anchoring elements. The artificial chord prosthesis enters the heart through the delivery system, the leaflet anchoring elements connect to the leaflets, and the papillary muscle anchoring elements connect to the papillary muscles, thereby replacing the stretched or broken native chords and eliminating or alleviating mitral regurgitation. Only when the artificial chords are firmly and reliably connected to the leaflets and papillary muscles can treatment be effectively achieved. Since the papillary muscles belong to the ventricular myocardial trabeculae system and have a relatively thick and dense structure, the various existing methods of fixing interventional devices in the ventricle (such as spiral screwing, barb anchoring, etc.) can ensure firm anchoring. The connection technology between artificial chords and leaflets is more difficult to implement, mainly reflected in two aspects: 1. Fixation reliability. To prevent thrombosis in artificial chordal prostheses, current artificial chords are made of polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (EPTFE). These materials are highly lubricating and difficult to tie firmly. Secondly, leaflet tearing. During ventricular systole, the leaflets flip upward, pulling on the chordae tendineae. Literature suggests that during this period, the chordae tendineae can be subjected to forces as high as 1.7N. The mitral valve leaflets are composed of a spongy atrial layer and a fibrous ventricular layer, with a thickness of 1-4 mm and relatively low strength. The traction of the chordae tendineae generates significant localized stress, which can easily lead to leaflet tearing, causing the artificial chordae to fall off and rendering the treatment ineffective. In the prior art, the main methods for leaflet anchoring are metal anchor claws, knots, and gaskets. For example, Cardiomech has designed a metal anchor claw. This type of anchoring carries a high surgical risk. Firstly, the anchor claw punctures and grasps the leaflet, causing a large wound and potentially causing acute leaflet perforation. Secondly, metal implantation can cause metal allergies or immune reactions. Other problems may also arise, such as additional load on the leaflets, changing the surface morphology of the leaflets, affecting hemodynamics, etc. At the same time, metal anchor claws are not conducive to tissue growth and cannot form endothelialization in a short period of time. Summary of the Invention

[0005] In view of the above-mentioned shortcomings of the prior art, an object of the present invention is to provide an implant and a component for forming the implant, so as to solve the problems in the prior art.

[0006] To achieve the above-mentioned purpose and other related purposes, the first aspect of the present application provides an implant, which includes an artificial chord tendon and a papillary muscle anchoring element. The artificial chord tendon includes an artificial chord tendon body and a self-tightening structure for anchoring the leaflet formed at one end of the artificial chord tendon body, and the other end of the artificial chord tendon body is connected to the papillary muscle anchoring element.

[0007] The self-tightening structure for anchoring the leaflet includes a self-tightening knot and a leaflet anchoring ring, and the leaflet anchoring ring is closed and locked at the self-tightening knot.

[0008] The self-tightening knot is selected from the group consisting of a Bollinger knot, a rope knot, a double hitch, and a square knot.

[0009] Preferably, the implant further comprises a gasket, the leaflet anchoring ring passes through the gasket, the gasket comprises a first gasket and / or a second gasket, the leaflet anchoring ring cooperates with the first gasket and / or the second gasket and is locked via the self-tightening knot to form a leaflet anchoring structure.

[0010] The papillary muscle anchoring element is in a spiral shape, a column shape with barbs, or an anchor-like shape.

[0011] A second aspect of the present invention provides a component for forming the implant, the component comprising an artificial chordal wire body and a papillary muscle anchoring element, the artificial chordal wire body comprising a guiding connecting segment, an artificial chordal body segment and a segment for forming a self-tightening structure, the artificial chordal wire body being suitable for forming the artificial chordal wire body in the implant, and optionally, the component further comprising a gasket.

[0012] The free end of the guiding connecting section is provided with a magnetic block, a mortise and tenon structure or a snap-fit ​​structure; preferably, the guiding connecting section can be removed by shearing.

[0013] The artificial chordal wire body is selected from wire.

[0014] The third aspect of the present invention provides an interventional artificial tendon repair device, which includes the component, a connecting guide wire and a delivery system. The connecting guide wire is arranged in the delivery system, and the delivery system is provided with a channel adapted to the artificial tendon line body in the component.

[0015] Preferably, the connecting guide wire is selected from a metal wire. Further, when the interventional artificial chordal repair device is implanted, the connecting guide wire and the guiding connecting section are detachably connected.

[0016] Preferably, the conveying system includes a first chuck and a second chuck, a U-shaped channel is provided in the first chuck, and the second chuck is provided with a central channel, a first side wall channel and a second side wall channel, one end of the first side wall channel and one end of the second side wall channel are connected to the central channel, and in use, the other end of the first side wall channel and the other end of the second side wall channel are respectively aligned with the two openings of the U-shaped channel.

[0017] Preferably, the interventional artificial chord repair device also includes an auxiliary connecting guide wire and an auxiliary connecting line. The auxiliary connecting guide wire is detachably connected to the guiding connecting section. The auxiliary connecting line is arranged in a U-shaped channel, one end of which is detachably connected to the guiding connecting section and / or the auxiliary connecting guide wire, and the other end of which is detachably connected to the connecting guide wire.

[0018] A fourth aspect of the present invention provides a method for forming the implant, the method comprising the following steps:

[0019] 1) Wrapping a portion of the artificial chordal line around the connecting guide wire;

[0020] 2) Clamping the first and second chucks of the conveying system so that the opening of the first sidewall channel and the opening of the second sidewall channel provided on the second chuck are aligned with the two openings of the U-shaped channel provided on the first chuck;

[0021] 3) Select one or two of the following steps:

[0022] i. Push the connecting guide wire along the first side wall channel to connect the guide wire into the U-shaped channel and connect it to the guide connecting segment on the artificial tendon line;

[0023] ii. Push the auxiliary connecting guide wire along the second side wall channel to connect the guide connecting section on the artificial tendon chord body to the auxiliary connecting wire provided in the U-shaped channel, push the connecting guide wire along the first side wall channel, so that the connecting guide wire enters the U-shaped channel, connects to the auxiliary connecting wire, and withdraws the auxiliary connecting guide wire;

[0024] 4) Retract the connecting guidewire to allow the artificial chordae to form a self-tightening knot and leaflet anchoring ring;

[0025] 5) Continue to withdraw the connecting guidewire so that the guiding connecting segment and the artificial tendon body segment pass through the self-tightening knot;

[0026] 6) Tighten the self-tightening knot;

[0027] 7) The artificial chord body is movably connected to the papillary muscle anchoring element, the length of the artificial chord body is adjusted, the guiding connection section is cut off, and the artificial chord body is fixedly connected to the papillary muscle anchoring element to form an implant.

[0028] A fifth aspect of the present invention provides use of the implant, the component, or the interventional artificial chordal repair device in the preparation of a product for treating mitral valve regurgitation.

[0029] As described above, the implant, the assembly, and the interventional artificial chordal repair device of the present invention have the following beneficial effects:

[0030] 1) The leaflet fixation method of the artificial chordal prosthesis has been optimized. This method replaces surgical thoracotomy and completes the fixation of the artificial chordal prosthesis to the leaflet through intervention, reducing the trauma of the surgery to the body.

[0031] 2) Metal-free implantation can be achieved without causing metal allergies or immune reactions.

[0032] 3) The self-tightening knot is different from the movable knot as a way to anchor the valve leaflet. After being fixed, the self-tightening knot will not shift, which reduces the friction between the knot and the valve leaflet. The anchoring wound is small, the damage to the native valve leaflet is small, and the valve leaflet is not easily torn. It is firmly fixed, the anchoring effect is good, and the reflux treatment effect is stable. At the same time, the self-tightening knot causes less damage to the native valve leaflet than the metal anchor claw, which is conducive to the rapid endothelialization of the implant and the better endothelialization effect, and will not change the anatomical morphology of the valve leaflet. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 Shown is a schematic diagram of the implant of this application.

[0034] Figure 2 The following are four schematic diagrams of self-tightening knots of the present invention, which are: double knot ( Figure 2 (a)), Rope knot ( Figure 2 (b)), flat knot ( Figure 2 (c)), Bollinger knot ( Figure 2 (d)).

[0035] Figure 3 Shown are three schematic diagrams of the papillary muscle anchoring element structures of the present application, which are spiral structures ( Figure 3 (a)), barbed structure ( Figure 3 (b)), anchor-like structure ( Figure 3 (c)).

[0036] Figure 4 Shown is a schematic diagram of the interventional artificial chordal repair device of the present application.

[0037] Figure 5a to Figure 5e Shown is a schematic diagram of the steps for using the interventional artificial chordal repair device of the present application.

[0038] Figure 6 Shown is another schematic diagram of the interventional artificial chordal repair device of the present application.

[0039] Figure 7a to Figure 7c Display as Figure 6 Schematic diagram of the steps for using the interventional artificial chordal repair device.

[0040] Figure 8 Shown is a schematic diagram of the steps for using the interventional artificial chordal repair device of the present application.

[0041] Component number description

[0042] 1 Artificial chordae tendineae

[0043] 11 Artificial chord body

[0044] 12 Leaflets with self-tightening structure

[0045] 121 Self-tightening knot

[0046] 122 Leaflet Anchoring Ring

[0047] 2 Papillary muscle anchoring elements

[0048] 3 gaskets

[0049] 31 First gasket

[0050] 32 Second gasket

[0051] 41 Connecting the guide wire

[0052] 42 Auxiliary connection guide wire

[0053] 43 Auxiliary cable

[0054] 431 First connection end

[0055] 432 Second connection terminal

[0056] 5 Conveying system

[0057] 51 First chuck

[0058] 511 U-shaped channel

[0059] 52 Second chuck

[0060] 521 Central Channel

[0061] 522 First side wall channel

[0062] 523 Second side wall channel

[0063] 6 leaflets DETAILED DESCRIPTION

[0064] The following describes the implementation of the present invention through specific embodiments. People skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.

[0065] See also Figures 1 to 8 . It should be noted that the structures, proportions, sizes, etc. illustrated 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 limiting conditions for the implementation of the present invention. Therefore, they have no substantive 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 that can be achieved by 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.

[0066] like Figure 1 As shown, the first aspect of the present application provides an implant, which includes an artificial chord 1 and a papillary muscle anchoring element 2, wherein the artificial chord 1 includes an artificial chord body 11 and a self-tightening structure 12 for anchoring the leaflet formed at one end of the artificial chord body 11, and the other end of the artificial chord body 11 is connected to the papillary muscle anchoring element 2.

[0067] The self-tightening structure 12 for anchoring the leaflet includes a self-tightening knot 121 and a leaflet anchoring ring 122. The leaflet anchoring ring 122 is closed and locked at the self-tightening knot.

[0068] like Figure 2 As shown, the self-tightening knot 121 is a knot that can be locked when one end of the thread is tightened. The self-tightening knot 121 is selected from a double knot ( Figure 2 (a)), Rope knot ( Figure 2 (b)), flat knot ( Figure 2 (c)), Bollinger knot ( Figure 2 (d) The self-tightening knot 121 is preferably a rope end knot. The rope end knot is simple, fast and easy to implement.

[0069] The self-tightening knot 121 can be locked by tightening one end of the suture through different winding methods.

[0070] The self-tightening knot 121 and the leaflet anchoring ring 122 can be an integrated structure with the artificial chord body 11, or can be three independent structures connected together, or the artificial chord body 11 and the leaflet anchoring ring 122 can be an integrated structure. The self-tightening knot is a knot formed by a separate suture for locking the leaflet anchoring ring 122.

[0071] In a preferred embodiment, the self-tightening knot 121 and the leaflet anchoring ring 122 are integrally formed with the artificial chord body 11. Using the artificial chord 1 to wrap itself into a knot avoids the use of excessive sutures in vivo, facilitates control, prevents the knot from loosening, and increases the speed of operation.

[0072] In such Figure 1 In the illustrated embodiment, the implant further comprises a spacer, and the leaflet anchoring ring 122 passes through the spacer 3 .

[0073] In one embodiment, the gasket 3 includes a first gasket 31 and / or a second gasket 32, and the leaflet anchoring ring 122 cooperates with the first gasket 31 and / or the second gasket 32 ​​and is locked by the self-tightening knot 121 to form a leaflet anchoring structure.

[0074] In one embodiment, the first gasket 31 is a thin sheet structure with a thickness of 0.1-2 mm, preferably 0.3-1 mm.

[0075] The shape of the first gasket 31 can be selected from polygonal, circular, and elliptical shapes, preferably quadrilateral and elliptical. When the first gasket 31 is quadrilateral, the length of the quadrilateral is 1-10 mm, preferably 2-4 mm, and the width is 1-4 mm, preferably 1-2 mm. When the first gasket 31 is elliptical, the major axis of the ellipse is 1-10 mm, preferably 2-4 mm, and the minor axis is 1-4 mm, preferably 1-2 mm.

[0076] The second gasket 32 ​​is a thin sheet structure with a thickness of 0.1-2 mm, preferably 0.3-1 mm.

[0077] The shape of the second gasket 32 ​​can be polygonal, circular, or elliptical, preferably quadrilateral or elliptical.

[0078] When the second gasket 32 ​​is a quadrilateral, the length of the quadrilateral is 1-10 mm, preferably 2-4 mm, and the width is 1-4 mm, preferably 1-2 mm. When the second gasket 32 ​​is an ellipse, the major axis of the ellipse is 1-10 mm, preferably 2-4 mm, and the minor axis is 1-4 mm, preferably 1-2 mm.

[0079] The materials of the first gasket 31 and the second gasket 32 ​​can be selected from polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (EPTFE), polyethylene terephthalate (PET), polyester, felt, mesh wire weaving, etc. The material of the first gasket 31 is preferably expanded polytetrafluoroethylene and polyethylene terephthalate.

[0080] The first gasket 31 and the second gasket 32 ​​can have the same or different structures, shapes and materials, and can be used alone or in combination. The first gasket 31 and the second gasket 32 ​​can reduce the local pulling stress of the valve leaflet, accelerate endothelialization, and increase anchoring stability.

[0081] like Figure 3 As shown, the papillary muscle anchoring element 2 is selected from spiral ( Figure 3 (a))、Barbs( Figure 3 (b)), anchor-like structure ( Figure 3 (c) The papillary muscle anchoring element 2 can be embedded in the myocardial tissue to serve as a fixing mechanism connecting the artificial tendon 1 to the myocardium.

[0082] The second aspect of the present invention provides a component for forming the implant, which includes an artificial chordal wire body and a papillary muscle anchoring element 2. The artificial chordal wire body includes a guiding connecting segment, an artificial chordal body segment and a segment for forming a self-tightening structure. The artificial chordal wire body is suitable for forming the artificial chordal wire 1 in the implant.

[0083] Specifically, the component further includes a gasket, and the leaflet anchoring ring 122 passes through the gasket 3.

[0084] In one embodiment, the gasket 3 includes a first gasket 31 and a second gasket 32 ​​, and the leaflet anchoring ring 122 cooperates with the first gasket 31 and the second gasket 32 ​​and is locked by the self-tightening knot 121 to form a leaflet anchoring structure.

[0085] The artificial tendon chord is selected from a wire material. Specifically, the wire material complies with the requirements of the YY 0167-2020 standard.

[0086] Generally, the diameter of the wire can be selected from 5-0, 4-0, 3-0, 2-0 / T, and 2-0. Preferably, the diameter of the wire is 3-0 or 2-0. Clinical data show that 3-0 and 2-0 diameter wires are more suitable for the use of chordae tendineae.

[0087] The wire can be a single-strand or multi-strand braided structure. A single-strand structure is preferred. A single-strand structure is more stable, while multi-strand structures have the risk of snagging, twisting, or twisting.

[0088] The material of the wire can be selected from polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (EPTFE), polyethylene terephthalate (PET), ultra-high molecular weight polyethylene (UHMWPE), mulberry silk, nylon, cotton, etc. The material of the wire is preferably polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (EPTFE). This invention does not impose any particular limitation on this.

[0089] Preferably, the function of the guiding connecting segment is to assist in guiding the movement of the artificial chord body segment and the self-tightening structure forming segment during transportation. After the assistance is completed, the guiding connecting segment is cut off and does not remain in the body. Preferably, the guiding connecting segment can be developed under DSA, and you can choose to add a developer to the guiding connecting segment, or wrap a developing wire around it, or use a detachable connecting piece that can be developed, such as gold, platinum, PtW alloy, tantalum or PtIr alloy. There is no clear division between the boundaries of the above segments. The guiding connecting segment only plays a guiding role. The self-tightening structure forming segment corresponds to the segment in the implant that forms the self-tightening structure 12 for anchoring the leaflets, and the artificial chord body segment corresponds to the segment in the implant that serves as the artificial chord body.

[0090] The guiding connecting segment, the artificial chord body segment, and the self-tightening structure-forming segment can be different segments of a single wire, or can be three wires, or can be two wires, in which case the guiding connecting segment and the artificial chord body segment form one wire, and the self-tightening structure-forming segment forms another wire. Of course, other combinations are also possible, as long as the implant can be formed.

[0091] like Figure 3 As shown, the papillary muscle anchoring element 2 is selected from spiral ( Figure 3 (a))、Barbs( Figure 3 (b)), anchor-like structure ( Figure 3 (c) The papillary muscle anchoring element 2 can be embedded in the myocardial tissue to serve as a fixing mechanism connecting the artificial tendon 1 to the myocardium.

[0092] like Figure 4 As shown, the third aspect of the present invention provides an interventional artificial tendon repair device, which includes an implant, a connecting guide wire 41 and a delivery system 5. The connecting guide wire 41 is arranged in the delivery system 5, and the delivery system 5 is provided with a channel adapted to the artificial tendon line body in the component.

[0093] In one embodiment, the connecting guide wire 41 is selected from a metal wire. Preferably, it is selected from a metal wire that is elastic and has good support performance. The diameter of the connecting guide wire 41 is 0.2-1.5 mm, preferably 0.5-1.0 mm. The structure of the connecting guide wire 41 can be a single strand, a core shaft plus internal and external springs, etc., preferably a single strand. The material of the metal wire can be nickel-titanium alloy, stainless steel, titanium alloy, preferably nickel-titanium alloy. The tip of the connecting guide wire 41 is in the shape of a sharp needle.

[0094] Furthermore, when the artificial tendon repair device is implanted, the connecting guide wire 41 is detachably connected to the free end of the guiding connecting section. The detachable connection method can be snap, magnetic, mortise and tenon, coupling, etc., which is not specifically limited in the present invention.

[0095] In such Figure 4 In the illustrated embodiment, the conveying system 5 includes a first chuck 51 and a second chuck 52. The first chuck 51 is provided with a U-shaped channel 511, and the second chuck 52 is provided with a central channel 521, a first side wall channel 522 and a second side wall channel 523. One end of the first side wall channel 522 and one end of the second side wall channel 523 are connected to the central channel 521. When in use, the other end of the first side wall channel 522 and the other end of the second side wall channel 523 are aligned with the two openings of the U-shaped channel 511 respectively.

[0096] Preferably, in use, the first clamp 51 and the second clamp 52 are respectively arranged at the same position on both sides of the leaflet 6 , that is, the first clamp 51 and the second clamp 52 can be aligned with each other across the leaflet 6 .

[0097] Specifically, the first clamp 51 and the second clamp 52 can move relative to each other, and clamp the leaflet when they are close to each other.

[0098] Specifically, when the first clamp 51 and the second clamp 52 are close to each other, one end of the first side wall channel 522 and one end of the second side wall channel 523 are aligned with the two openings of the U-shaped tube 511 respectively, and the connecting guide wire 41 can pass through the second gasket 32, the leaflet 6, and the first gasket 31 and then enter the U-shaped tube 511.

[0099] Before use, the interventional artificial chord repair device is pre-placed between the U-shaped channel 511 in the first clamp 51 and the leaflets. The second gasket 32 ​​is pre-placed between the central channel 521, the first sidewall channel 522, or the second sidewall channel 523 in the second clamp 52 and the leaflets. The connecting guidewire 41 is pre-placed in the central channel 521. The pre-placed connecting guidewire 41 is obliquely inserted into the first sidewall channel 522. The self-tightening knot 121 is wrapped around the connecting guidewire 41, and the connecting section is placed in the second sidewall channel 523. The interventional artificial chord repair device is used to form the implant.

[0100] like Figure 5a to Figure 5e As shown, the method for forming the implant comprises the following steps:

[0101] 1) If Figure 5a , a portion of the artificial chordal wire is wrapped around the connecting guide wire 41; when the first clamp 51 and the second clamp 52 are clamped, the opening of the first side wall channel 522 and the opening of the second side wall channel 523 are aligned with the two openings of the U-shaped channel 511 respectively, and the connecting guide wire 41 is pushed in the direction of the arrow shown in the figure to sequentially penetrate the second gasket 32, the leaflet 6, and the first gasket 31 and enter the U-shaped channel 511;

[0102] 2) If Figure 5b, continue to push the connecting guide wire 41 in the direction of the arrow shown in the figure, the connecting guide wire 41 enters the U-shaped channel 511, and is connected to the guiding connecting section; optionally, the connecting guide wire 41 sequentially penetrates the first gasket 31, the leaflet 6, and the second gasket 3 in the U-shaped channel 511 before being connected to the guiding connecting section;

[0103] 3) If Figure 5c , withdraw the connecting guide wire 41 in the direction of the arrow shown in the figure. The connecting guide wire 41 will drive the guiding connecting segment, the artificial chord body segment, and the self-tightening structure forming segment to pass through the second gasket 32, the leaflet 6, and the first gasket 31 in sequence. Then, the self-tightening structure forming segment will close the loop at the self-tightening knot to form the leaflet anchoring ring 122.

[0104] 4) If Figure 5d , continue to withdraw the connecting guide wire 41, so that the artificial chord tendon body forms a self-tightening knot 121;

[0105] 5) If Figure 5e , remove the first chuck 51 and the second chuck 52, and tighten the self-tightening knot 121;

[0106] 6) Pass the artificial chord tendon body through the papillary muscle anchoring element 2 to make the two movably connected, adjust the length of the artificial chord tendon body, cut off the guiding connecting section, and fix the artificial chord tendon body to the papillary muscle anchoring element 2 to form an implant.

[0107] In such Figure 6 In the illustrated embodiment, the interventional artificial chord repair device further includes an auxiliary connecting guidewire 42 and an auxiliary connecting wire 43. The auxiliary connecting guidewire 42 is detachably connected to the guide connecting segment. The auxiliary connecting wire 43 is disposed within the U-shaped channel 511, with one end detachably connected to the guide connecting segment and / or the auxiliary connecting guidewire 42 and the other end detachably connected to the connecting guidewire 41. The provision of the auxiliary connecting guidewire 42 and the auxiliary connecting wire 43 allows for faster implantation.

[0108] The detachable connection is selected from snap, magnetic, mortise and tenon, coupling, etc. The auxiliary connecting guide wire 42 is used to guide the self-tightening structure forming line segment and the artificial tendon body segment into the U-shaped channel 511 through the guiding connecting segment connected at one end.

[0109] like Figure 6As shown, the auxiliary connecting wire 43 includes a first connecting end 431 and a second connecting end 432. When implanted, the first connecting end 431 is connected to the connecting guide wire 41, and the second connecting end 432 is connected to one end of the auxiliary connecting guide wire 42. Preferably, the connection between the first connecting end 431 and the connecting guide wire 41, and the connection between the second connecting end 432 and the auxiliary connecting guide wire 42 are both detachable connections. The function of the auxiliary connecting wire 43 is to help the connecting guide wire 41 to achieve connection with the guide connecting section. Among them, the auxiliary connecting wire 43 and the guide connecting section are detachably connected. The detachable connection is selected from the following methods: snap, magnetic, mortise and tenon, coupling, etc. The auxiliary connecting wire 43 can realize development under DSA, and you can choose to add developer to the auxiliary connecting wire 43, or wrap a metal wire around it, or the connection structure at both ends of the auxiliary connecting wire 43 uses metal material.

[0110] Before using the interventional artificial chord repair device, the connecting guide wire 41 and the auxiliary connecting guide wire 42 are preset in the central channel 521 ; and the auxiliary connecting wire 43 is preset in the U-shaped channel 511 .

[0111] like Figure 7a to Figure 7c As shown, the method for forming the implant comprises the following steps:

[0112] 1) If Figure 7a As shown, a portion of the artificial tendon chord is wrapped around the connecting guide wire 41; when the first clamp 51 and the second clamp 52 are clamped, the opening of the first side wall channel 522 and the opening of the second side wall channel 523 are aligned with the two openings of the U-shaped channel 511 respectively, and the connecting guide wire 41 is pushed along the direction of the arrow in the figure into the U-shaped channel 511 and connected to the second connecting end 432; at the same time, the auxiliary connecting guide wire 42 is pushed along the direction of the arrow in the figure into the U-shaped channel 511 and connected to the first connecting end 431. At this time, the guiding connecting segment is carried by the auxiliary connecting guide wire 42 and enters the U-shaped channel 511 and connects to the first connecting end 431. Optionally, the connecting guide wire 41 and the auxiliary connecting guide wire 42 both penetrate the second gasket 32, the leaflet 6, and the first gasket 31 in sequence and enter the U-shaped channel 511.

[0113] 2) If Figure 7b As shown, the connecting guide wire 41 and the auxiliary connecting guide wire 42 are withdrawn in the direction of the arrow in the figure. At this time, the auxiliary connecting guide wire 42 is separated from the second connecting end 432, and the second connecting end 432 maintains a detachable connection with the guiding connecting section.

[0114] 3) If Figure 7c, the auxiliary connecting guide wire 42 is withdrawn in the direction of the arrow shown in the figure. After the auxiliary connecting guide wire 42 is withdrawn, it is no longer used. At the same time, the connecting guide wire 41 is withdrawn. The connecting guide wire 41 drives the auxiliary connecting wire 43 to move. The auxiliary connecting wire 43 drives the guiding connecting segment, the artificial chord body segment, and the self-tightening structure forming segment to move. The self-tightening structure forming segment closes the loop at the self-tightening wire knot to form the leaflet anchoring ring 122. Optionally, the auxiliary connecting wire 43 drives the guiding connecting segment, the artificial chord body segment, and the self-tightening structure forming segment to move through the first gasket 31, the leaflet 6, and the second gasket 32 ​​in sequence.

[0115] 4) Continue to withdraw the connecting guide wire 41 so that the guiding connecting segment and the artificial tendon body segment pass through the self-tightening knot 121 .

[0116] 5) Remove the first chuck 51 and the second chuck 52 and tighten the self-tightening knot 121;

[0117] 6) Pass the artificial tendon chord through the papillary muscle anchoring element 2 to make the two movably connected, and adjust the length of the artificial tendon body.

[0118] After cutting off the guiding connecting section, the artificial tendon body is fixedly connected to the papillary muscle anchoring element 2.

[0119] A fourth aspect of the present application provides use of the implant, the component, or the interventional artificial chordal repair device in preparing a product for treating mitral valve regurgitation.

[0120] like Figure 8 As shown, the steps of using the interventional artificial tendon repair device are as follows: the delivery system 5 enters the atrium through the atrial septum through the universal sheath ( Figure 8 (a)); Pushing the delivery system 5, completes the leaflet clamping with the assistance of ultrasound and DSA medical imaging equipment ( Figure 8 (b)); Release the gasket 3 and the leaflet self-tightening structure 12, pull back the delivery system 5, and withdraw the artificial tendon 1 ( Figure 8 (c)); The papillary muscle anchoring element 2 is anchored to the left ventricular myocardium by the delivery system 5 ( Figure 8 (d)); withdraw the delivery system 5, at which point the papillary muscle anchoring element 2 is connected to one end of the guide connecting section, and adjust the length of the artificial tendon with the aid of ultrasound imaging to ensure that there is no reflux ( Figure 8 (e)). After adjusting the length, cut off the guide connecting section. The final state of the implant in the heart is as follows: Figure 8 (f) shown.

[0121] The use of the implant or the interventional artificial chordal repair device allows for the fixation of artificial chordae to the valve leaflets through an interventional approach, without the need for thoracotomy, resulting in minimal surgical trauma and rapid patient recovery. Furthermore, the fixation is secure and less likely to cause leaflet tearing, while also facilitating rapid endothelialization of the implant and wound healing.

[0122] In summary, the present invention effectively overcomes various shortcomings of the prior art and has high industrial utilization value.

[0123] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the present invention. Anyone skilled in the art may modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by one of ordinary skill in the art without departing from the spirit and technical principles disclosed herein are intended to be covered by the claims of the present invention.

Claims

1. An interventional artificial chordal repair device, characterized in that: The repair device comprises an implant component, a connecting guide wire (41) and a delivery system (5), wherein the implant component comprises an artificial tendon chord body and a papillary muscle anchoring element (2), wherein the artificial tendon chord body comprises a guiding connecting segment, an artificial tendon body segment and a self-tightening structure forming segment, wherein the artificial tendon chord body is suitable for forming an artificial tendon chord (1), wherein the artificial tendon chord (1) comprises an artificial tendon body (11) and a self-tightening structure (12) for anchoring the leaflet formed at one end of the artificial tendon body (11), wherein the self-tightening structure (12) for anchoring the leaflet comprises a self-tightening knot (121) and a leaflet anchoring ring (122), wherein the leaflet anchoring ring (122) is closed and locked at the self-tightening knot, wherein the self-tightening knot (121) is selected from Bollinger knot, rope knot, double knot, flat knot, the other end of the artificial tendon body (11) is connected to the papillary muscle anchoring element (2); the implant component also includes a gasket (3), the leaflet anchoring ring (122) passes through the gasket (3), the gasket includes a first gasket (31) and a second gasket (32), the leaflet anchoring ring (122) cooperates with the first gasket (31) and the second gasket (32) and is locked by the self-tightening knot (121) to form a leaflet anchoring structure; the connecting guide wire (41) is arranged in the conveying system (5), and the conveying system (5) is provided with a channel adapted to the artificial tendon body in the implant component; after the repair device forms an implant, the guiding connecting section is sheared and removed.

2. The interventional artificial chord repair device according to claim 1, characterized in that: The papillary muscle anchoring element (2) is in a spiral shape, a columnar shape with barbs, or an anchor-like shape.

3. The interventional artificial chord repair device according to claim 1, characterized in that: The free end of the guiding connecting section is provided with a magnetic block or a snap-fit ​​structure.

4. The interventional artificial chord repair device according to claim 1, characterized in that: The free end of the guiding connecting section is provided with a mortise and tenon structure.

5. The interventional artificial chord repair device according to claim 1, characterized in that: The connecting guide wire (41) is selected from metal wires; the connecting guide wire (41) is detachably connected to the free end of the guiding connecting section.

6. The interventional artificial chord repair device according to claim 1, characterized in that: The conveying system (5) comprises a first clamp (51) and a second clamp (52), wherein a U-shaped channel (511) is provided in the first clamp (51), and the second clamp (52) is provided with a central channel (521), a first side wall channel (522) and a second side wall channel (523), wherein one end of the first side wall channel (522) and one end of the second side wall channel (523) are both connected to the central channel (521), and in a state of use, the other end of the first side wall channel (522) and the other end of the second side wall channel (523) are respectively aligned with the two openings of the U-shaped channel (511).

7. The interventional artificial chord repair device according to claim 6, characterized in that: The interventional artificial tendon repair device also includes an auxiliary connecting guide wire (42) and an auxiliary connecting line (43), wherein the auxiliary connecting guide wire (42) is detachably connected to the guiding connecting section, and the auxiliary connecting line (43) is arranged in the U-shaped channel (511), with one end detachably connected to the guiding connecting section and / or the auxiliary connecting guide wire (42), and the other end detachably connected to the connecting guide wire (41).

8. The interventional artificial chord repair device according to claim 7, characterized in that: The detachable connection is selected from a magnetic connection or a snap connection.

9. The interventional artificial chord repair device according to claim 7, characterized in that: The detachable connection is selected from the mortise and tenon connection.

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