WO2022027941A1

WO2022027941A1 - Implant and assembly used in forming same

Info

Publication number: WO2022027941A1
Application number: PCT/CN2021/074686
Authority: WO
Inventors: 郭扬
Original assignee: 上海端佑医疗科技有限公司
Priority date: 2020-08-03
Filing date: 2021-02-01
Publication date: 2022-02-10

Abstract

An implant and an assembly used in forming same. The implant comprises an artificial chordae tendineae (1) and a papillary muscle anchor element (2). The artificial chordae tendineae (1) comprises an artificial chordae tendineae body (11) and a self-tightening structure (12) formed on one end of the artificial chordae tendineae body (11) and used for anchoring a leaflet. The other end of the artificial chordae tendineae body (11) connects to the papillary muscle anchor element (2). The implant optimizes a leaflet securing means of the artificial chordae tendineae prosthesis, completing the securing of the artificial chordae tendineae to the leaflet by means of interventional surgery, and opening the chest is unnecessary, surgery trauma is low, and patient recovery is rapid; a self-tightening thread knot will not be displaced, decreasing friction between the thread knot and the leaflet, the wound surface of the anchor is small, there is little damage to the native leaflet, the anchoring effect is good, and the reflux treatment effect is stable; additionally, rapid endothelialization of the implant is facilitated, endothelialization results are better, and the anatomical form of the leaflet will not be changed.

Description

An implant and components for forming the implant

technical field

The present invention relates to the field of medical devices, in particular to an implant and an assembly for forming the implant.

Background technique

The mitral valve is a complex tissue structure between the left atrium (LA) and the left ventricle (LV), consisting of the mitral valve annulus, anterior mitral valve leaflets, posterior mitral valve leaflets, mitral valve chordae tendineae and papillary muscles composition. The mitral valve ensures that blood can only flow from the left atrium to the left ventricle, not the reverse. A normal healthy mitral valve has multiple chordae tendineae, one end of which connects to the leaflet edge and one end to the papillary muscle located in the ventricular wall. When the left ventricle is in diastole, the anterior and posterior leaflets of the mitral valve are opened, the chordae tendineae are in a relaxed state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in the systolic phase, the anterior and posterior leaflets of the mitral valve are in opposition under the action of blood pressure, and at the same time Due to the pulling effect of the chordae tendineae, the valve leaflets will not be turned over to the atrial side due to blood pressure. Under the combined action of the valve leaflets and the chordae tendineae, the blood flow channel between LA and LV is closed, and blood can only pass through the left ventricle. The aortic valve (AV for short) flows into the aorta and sends it to various organs throughout the body. When the chordae tendineae or papillary muscles have lesions, or are impacted by external forces, part of the chordae tendineae is often elongated or ruptured. When the left ventricle contracts, the valve leaflets are turned over to the side of the atrium due to the loss of chordae tendineae traction under the action of blood pressure. , causing the valve leaflets to fail to close tightly, resulting in blood regurgitation, that is, mitral regurgitation. When acute severe mitral regurgitation occurs (such as rupture of the chordae tendineae caused by external forces such as impact), the hemodynamics changes sharply, and a large amount of arterial blood refluxes into the left atrium, resulting in pulmonary congestion and a sharp increase in capillary pressure. Acute pulmonary edema, with severe clinical symptoms such as dyspnea and hemoptysis, will lead to death if the patient does not receive immediate clinical intervention. If only individual chordae tendineae rupture produces mild-to-moderate mitral regurgitation, the patient will not experience immediate clinical symptoms due to the compensatory function of the heart, but increased tension of other chordae tendineae will produce new chordae tendineae ruptures, and left atrial pressure rises High, will lead to the gradual expansion of the left atrium and mitral valve annulus, aggravate the degree of regurgitation, increase left ventricular preload, lead to left ventricular dilatation and systolic dysfunction, and then lead to left heart failure, and often lead to global heart failure, severe Endanger the patient's life and health. Even if a few chordae tendineae are ruptured, the tension of other chordae tendineae can be increased and new chordae tendineae rupture can occur. It can be seen that the elongation or rupture of the chordae tendineae of the mitral valve has a great impact on human health and requires clinical intervention.

Mitral regurgitation due to lesions of the chordae tendineae or rupture of the chordae tendineae can usually be treated with drugs, surgery, or interventional procedures. Drug methods (such as antihypertensive, diuretic, etc.) are symptomatic treatment, which can only alleviate clinical symptoms, but 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 and thoracotomy, with the help of cardiopulmonary bypass to perform direct-view operation under the condition of cardiac arrest. The operation process is complicated, the risk of patient trauma and complications is high, and the hospitalization recovery time is long. It is not suitable for low cardiac function, many complications, Elderly and other high-risk surgical patients.

Interventional surgery is performed through puncture. Under the navigation of modern imaging equipment such as three-dimensional ultrasound and angiography, the device is sent into the heart through peripheral blood vessels, and the operation is completed without the heart beating, which greatly reduces the degree of trauma and the risk of complications. The only treatment option for high-risk surgical patients. The interventional artificial chord repair device generally includes a delivery system and an implant. The implant includes an artificial chord, a leaflet anchoring element and a papillary muscle anchoring element. The artificial chord prosthesis enters the heart from the delivery system. The leaflet anchoring elements connect the valve leaflets, and the papillary muscle anchoring elements connect the papillary muscles, thereby replacing the elongated or ruptured native chordae tendineae, eliminating or reducing mitral regurgitation. The artificial chordae tendineae can be effectively treated only when they are firmly and reliably connected with the valve leaflets and papillary muscles. Because the papillary muscle belongs to the trabecular system of the ventricular muscle, the structure is relatively thick and dense, and the existing fixation methods of various interventional instruments in the ventricle (such as screw screwing, barb anchoring, etc.) can ensure firm anchoring. The connection technology of artificial chordae tendineae and valve leaflets is more difficult to realize, mainly reflected in two aspects: First, the fixation reliability. In order to prevent the artificial chordae tendinea prosthesis from causing thrombosis in the heart, the material of the artificial chordae tendineae is currently polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (EPTFE). knot; two, leaflet tear. During ventricular systole, the valve leaflets are turned up and the chordae tendineae are stretched. Some literatures show that the maximum force on the chordae tendineae during ventricular systole can reach 1.7N. The mitral valve leaflets are composed of a cavernous atrial layer and a fibrous ventricular layer, with a thickness of 1-4 mm, the strength is low, and a large local stress is generated under the pulling action of the chordae tendineae, which can easily lead to tearing of the valve leaflets, thereby causing the artificial chordae tendineae to fall off and lose the therapeutic effect. It is known in the prior art that the main methods of leaflet anchoring are metal anchor claw, wire knot and spacer fixing. For example, Cardiomech designed a metal anchor, which has a high surgical risk. On the one hand, the wound caused by the anchor claw puncturing and grasping the valve leaflet is large, which is likely to cause acute perforation of the valve leaflet. Causes metal allergy or immune response. Other problems may also arise, such as extra load on the valve leaflets, changing the surface morphology of the valve leaflets, affecting hemodynamics, etc. At the same time, the metal anchors are not conducive to tissue growth and cannot form endothelialization in a short time.

SUMMARY OF THE INVENTION

In view of the above-mentioned shortcomings of the prior art, an object of the present invention is to provide an implant and an assembly for forming the implant to solve the problems in the prior art.

In order to achieve the above object and other related objects, a first aspect of the present application provides an implant, the implant includes an artificial chordae tendineae and a papillary muscle anchoring element, the artificial chordae tendineae includes an artificial chordae tendineae body and a The anchoring valve leaflet at one end of the artificial chord body uses a self-tightening structure, and the other end of the artificial chord body is connected with the papillary muscle anchoring element.

The self-tightening structure for anchoring valve leaflets includes a self-tightening wire knot and a valve leaflet anchoring ring, and the valve leaflet anchoring ring is closed and locked at the self-tightening wire knot.

The self-tightening knot is selected from the group consisting of Bollinger knots, rope end knots, double bar knots, and flat knots.

Preferably, the implant further includes a spacer through which the leaflet anchoring ring extends. The spacer includes a first spacer and/or a second spacer, and the leaflet anchoring ring is matched with the first spacer and/or the second spacer and is locked by the self-tightening knot to form a valve Leaf anchoring structure.

The papillary muscle anchoring element is in a spiral shape, a barb-shaped column or a ship-anchor-like shape.

A second aspect of the present invention provides an assembly for forming the implant, the assembly including an artificial chord body and a papillary muscle anchoring element, the artificial chord body including a connecting segment for guiding, an artificial chord The body segment and the wire segment for forming a self-tightening structure, the artificial tendon cable body is suitable for forming the artificial tendon cable in the implant, and optionally, the assembly further includes a spacer.

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

The artificial tendon cable body is selected from wires.

A third aspect of the present invention provides an interventional artificial chord repair device, the repair device includes the component, a connecting guide wire and a delivery system, the connecting guide wire is provided in the delivery system, and the delivery system is provided with an adaptor The channel of the artificial tendon cord body in the assembly.

Preferably, the connecting guide wire is selected from metal wires. Further, when the interventional artificial chordae tendineae repair device is implanted, the connecting guide wire and the guiding connecting segment are detachably connected.

Preferably, the delivery system includes a first chuck and a second chuck, the first chuck is provided with a U-shaped channel, the second chuck is provided with a central channel, a first side wall channel and a second side wall channel, the One end of the first side wall channel and one end of the second side wall channel are both communicated with the central channel. In the use state, 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.

Preferably, the interventional artificial chord repair device further comprises an auxiliary connecting guide wire and an auxiliary connecting wire, the auxiliary connecting guide wire is detachably connected to the connecting section for guiding, and the auxiliary connecting wire is arranged in the U-shaped channel, and one end of the auxiliary connecting wire is detachable. It is detachably connected with the guiding connecting segment and/or the auxiliary connecting guide wire, and the other end is detachably connected with the connecting guide wire.

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

1) Winding part of the artificial tendon cable body to connect the guide wire;

2) Clamp the first chuck and the second chuck of the conveying system, so that the opening of the first side wall channel and the opening of the second side wall channel provided on the second chuck are The two openings of the U-shaped channel on the head are aligned;

3) Choose one or two steps from the following:

i. Push the connecting guide wire along the first side wall channel, so that the connecting guide wire enters the U-shaped channel and is connected with the guiding connecting segment on the artificial tendon cable body;

ii. Push the auxiliary connection guide wire along the second side wall passage to connect the guide on the artificial tendon cable body with the auxiliary connection wire arranged in the U-shaped passage, and push the connection guide wire along the first side wall passage , make the connecting guide wire enter the U-shaped channel, connect with the auxiliary connecting wire, and withdraw the auxiliary connecting guide wire;

4) withdraw the connecting guide wire to make the artificial tendon cord body form a self-tightening knot and a leaflet anchoring ring;

5) Continue to withdraw the connecting guide wire, so that the connecting section for guiding and the body section of the artificial chordae tendinea pass through the self-tightening knot;

6) Tighten the self-tightening knot;

7) The artificial chordae tendineae body and the papillary muscle anchoring element are movably connected, the length of the artificial chord chordae body is adjusted, the connecting section for guiding is cut off, and the artificial chordae tendineae body and the papillary muscle anchoring element are fixedly connected to form an implant.

A fifth aspect of the present invention provides the use of the implant, the component or the interventional artificial chordae tendineae repair device in preparing a product for treating mitral valve regurgitation.

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

1) The leaflet fixation method of the artificial chordae tendineae prosthesis is optimized. This method replaces surgical thoracotomy, and the fixation of the artificial chordae tendineae and the valve leaflets is completed through interventional methods, reducing the trauma to the body.

2) Metal-free implantation can be achieved without causing metal allergy or immune response.

3) The self-tightening knot is different from the movable knot in the way of anchoring the valve leaflet. After the self-tightening knot is fixed, there will be no displacement, which reduces the friction between the knot and the valve leaflet. The anchoring wound is small, and the original valve leaflet is damaged. Small, not easy to produce leaflet tear, firm fixation, good anchoring effect, and stable regurgitation treatment effect; at the same time, the self-tightening knot has less damage to the native valve leaflet than the metal anchor claw, which is conducive to the rapid endothelialization of the implant, Endothelialization is better and does not change the anatomical shape of the valve leaflets.

Description of drawings

Figure 1 shows a schematic diagram of the implant of the present application.

Figure 2 shows a schematic diagram of four kinds of self-tightening thread knots of the present application, which are double bar knot (Figure 2a), rope end knot (Figure 2b), flat knot (Figure 2c), and Bollinger knot (Figure 2d).

Figure 3 is a schematic diagram showing the structure of three kinds of papillary muscle anchoring elements according to the present application, which are a spiral structure (Figure 3a), a barbed structure (Figure 3b), and a ship-anchor-like structure (Figure 3c).

FIG. 4 shows a schematic diagram of the interventional artificial chordae tendineae repair device of the present application.

FIG. 5 is a schematic diagram showing the steps of using the interventional artificial chordae tendineae repair device of the present application.

FIG. 6 shows another schematic diagram of the interventional artificial chord repair device of the present application.

FIG. 7 is a schematic diagram showing the steps of using the interventional artificial chord repair device of FIG. 6 .

FIG. 8 is a schematic diagram showing the steps of using the interventional artificial chordae tendineae repair device of the present application.

Component label description

1 Artificial tendine cord

11 Artificial tendon body

12 Self-tightening structure for leaflets

121 Self-tightening knot

122 Leaflet anchoring ring

2 Papillary Muscle Anchoring Element

3 Spacers

31 The first gasket

32 Second gasket

41 Connect the guide wire

42 Auxiliary connection guide wire

43 Auxiliary cable

431 The first connection terminal

432 Second connection terminal

5 Conveyor system

51 The first chuck

511 U-shaped channel

52 Second chuck

521 Center aisle

522 First side wall channel

523 Second sidewall channel

6 leaflets

detailed description

The embodiments of the present invention are described below by specific embodiments, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.

See Figures 1 through 8. It should be noted that the structures, proportions, sizes, etc. shown in the drawings in this specification are only used to cooperate with the contents disclosed in the specification, so as to be understood and read by those who are familiar with the technology, and are not used to limit the implementation of the present invention. Restricted conditions, it does not have technical substantive significance, any structural modification, proportional relationship change or size adjustment, without affecting the effect that the present invention can produce and the purpose that can be achieved, should still fall within the present invention. The disclosed technical content can cover the scope. At the same time, the terms such as "up", "down", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description and clarity, and are not used to limit this specification. The implementable scope of the invention, and the change or adjustment of the relative relationship thereof, shall also be regarded as the implementable scope of the present invention without substantially changing the technical content.

As shown in FIG. 1 , a first aspect of the present application provides an implant, the implant includes an artificial chord 1 and a papillary muscle anchoring element 2 , and the artificial chord 1 includes an artificial chord body 11 and a The self-tightening structure 12 is used for the anchoring leaflet 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 .

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

As shown in FIG. 2 , the self-tightening wire knot 121 is a wire knot that can be locked when one end of the wire end is tightened. The self-tightening thread knot 121 is selected from the group consisting of double bar knot (FIG. 2a), rope knot (FIG. 2b), flat knot (FIG. 2c), and Bollinger knot (FIG. 2d). The self-tightening knot 121 is preferably a rope knot. The rope knot knotting method is simple, fast and easy to implement.

The self-tightening knot 121 realizes that the knot can be locked when one end of the thread is tightened through different winding methods of the suture.

The self-tightening knot 121 and the leaflet anchoring ring 122 can be an integral structure with the artificial chord body 11, or can be three independent structures connected, or can be the artificial chord body 11 and the leaflet anchoring ring 122. As a one-piece construction, the self-tightening knot is a knot for locking the leaflet anchoring ring 122 with separate sutures.

In a preferred embodiment, the self-tightening wire knot 121 and the leaflet anchoring ring 122 and the artificial chord body 11 are integral structures. The artificial chordae 1 is wound into a knot by itself to avoid using too many sutures in the body, and at the same time, it is easy to control, avoid the loosening of the knot, and can also improve the operation speed.

In the embodiment shown in FIG. 1 , the implant further includes a spacer, and the leaflet anchoring ring 122 penetrates the spacer 3 .

In one embodiment, the spacer 3 includes a first spacer 31 and/or a second spacer 32, the leaflet anchoring ring 122 and the first spacer 31 and/or the second spacer 32 The valve leaflet anchoring structure is formed by matching and locking through the self-tightening wire knot 121 .

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

The shape of the first gasket 31 can be selected from polygonal, circular, oval, preferably quadrilateral and oval. When the shape of the first gasket 31 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 shape of the first gasket 31 is an ellipse, the long axis of the ellipse is 1-10 mm, preferably 2-4 mm, and the short axis is 1-4 mm, preferably 1-2 mm.

The second gasket 32 is a thin sheet structure. The thickness of the second gasket 32 is 0.1-2 mm, preferably 0.3-1 mm.

The shape of the second gasket 32 may be polygonal, circular or oval, preferably quadrilateral or oval.

When the shape of the second gasket 32 is quadrilateral, the quadrilateral length is 1-10mm, preferably 2-4mm, and the width is 1-4mm, preferably 1-2mm. When the shape of the second gasket 32 is an ellipse, the long axis of the ellipse is 1-10 mm, preferably 2-4 mm, and the short axis is 1-4 mm, preferably 1-2 mm.

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.

The structures, shapes and materials of the first gasket 31 and the second gasket 32 may be the same or different, and the two may be used alone or in combination. The first washer 31 and the second washer 32 play the roles of reducing the local traction stress of the valve leaflet, accelerating endothelialization, and increasing the anchoring stability.

As shown in Fig. 3, the papillary muscle anchoring element 2 is selected from the group consisting of helix (Fig. 3a), barb (Fig. 3b), and anchor-like structure (Fig. 3c). The papillary muscle anchoring element 2 can be embedded in myocardial tissue as a fixing mechanism for connecting the artificial chordae tendineae 1 with the myocardium.

A second aspect of the present invention provides an assembly for forming the implant, the assembly including an artificial chord body and a papillary muscle anchoring element 2, the artificial chord body including a connecting segment for guiding, an artificial tendon A cable body segment and a wire segment for forming a self-tightening structure, the artificial tendon cable body is suitable for forming the artificial tendon cable 1 in the implant.

Specifically, the assembly further includes a gasket, and the leaflet anchoring ring 122 penetrates the gasket 3 .

At least one of the spacers is provided. In one embodiment, the gasket 3 includes a first gasket 31 and a second gasket 32, and the leaflet anchoring ring 122 is matched with the first gasket 31 and the second gasket 32 and passed through the The self-tightening knot 121 is locked to form a leaflet anchoring structure.

The artificial tendon cable body is selected from wires. Specifically, the wire meets the requirements of the YY 0167-2020 standard.

Generally, the diameter specifications of the wire can be selected from 5-0, 4-0, 3-0, 2-0/T, and 2-0. The diameter of the wire is preferably 3-0, 2-0. Clinical data show that 3-0 and 2-0 diameter wires are closer to the needs of the chordae tendineae.

The structure of the wire can be single or multiple braided. The structure of the wire is preferably a single strand. Single strands are more stable in structure, and multiple strands run the risk of snagging, twisting or twisting.

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 rod is preferably polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (EPTFE). In this regard, the present invention does not make any special limitation.

Preferably, the guiding connecting segment is used to assist in guiding the movement of the artificial chord body segment and the line segment for forming the self-tightening structure during transportation. Preferably, the connecting section for guiding can realize development under DSA, and you can choose to add developer to the connecting section for guiding, or wrap the developing wire, or the detachable connecting piece is made of developable materials, such as gold, platinum, PtW alloy, Tantalum or PtIr alloy, etc. The boundaries of the above segments are not clearly demarcated, and the guiding connecting segment can play a guiding role. The line segment for forming the self-tightening structure corresponds to the line segment for forming the self-tightening structure 12 for anchoring the leaflet in the implant, while the main segment of the artificial chordae tendineae Then it corresponds to the line segment in the implant as the body of the artificial chordae tendineae.

The guiding connecting section, the artificial tendon body section and the self-tightening structure forming line can be different sections of one wire, three wires, or two wires. At this time, the guiding connecting section and the artificial tendon are The body segment is a wire, and the wire segment for forming the self-tightening structure is another wire. Of course, other combinations are possible as long as the implant can be formed.

As shown in FIG. 4 , a third aspect of the present invention provides an interventional artificial chord repair device, the repair device includes an implant, a connecting guide wire 41 and a delivery system 5 , and the connecting guide wire 41 is provided in the delivery system 5 . Inside, the delivery system 5 is provided with a channel adapted to the artificial tendon cord body in the assembly.

In one embodiment, the connecting guide wire 41 is selected from metal wires. Preferably, it is selected from metal wires that are elastic and have good supporting properties. 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 mandrel plus inner and outer springs, etc., preferably a single strand. The material of the metal wire can be selected from nickel-titanium alloy, stainless steel, titanium alloy, preferably nickel-titanium alloy. The head end of the connecting guide wire 41 is in the shape of a sharp needle.

Further, when the interventional artificial chord repair device is implanted, the connecting guide wire 41 is detachably connected to the free end of the connecting segment for guiding. The detachable connection method may be a snap, magnetic attraction, tenon and tenon, coupling, etc., which is not limited in the present invention.

In the embodiment shown in FIG. 4 , the delivery 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 , the first side wall channel 522 and the 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 communicated with the central channel 521. In the use state, the first side wall channel 522 is another One end and the other end of the second sidewall channel 523 are aligned with the two openings of the U-shaped channel 511 respectively.

Preferably, in the use state, the first chuck 51 and the second chuck 52 are respectively set at the same position on both sides of the leaflet 6 , that is, the first chuck 51 and the second chuck 52 can be aligned with the leaflet 6 apart.

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

Specifically, when the first collet 51 and the second collet 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 respectively aligned with the two openings of the U-shaped pipe 511, and the connecting guide The wire 41 can enter the U-shaped channel 511 after passing through the second gasket 32 , the valve leaflet 6 , and the first gasket 31 .

Before the interventional artificial chord repair device is used, the first gasket 31 is pre-placed between the U-shaped channel 511 and the valve leaflet in the first collet 51 , and the second gasket 32 is pre-placed in the center of the second collet 52 . Between the channel 521, the first side wall channel 522 or the second side wall channel 523 and the valve leaflets, the connecting guide wire 41 is pre-placed in the central channel 521; the preset connecting guide wire 41 is obliquely inserted into the first side wall channel 522; the self-tightening wire knot 121 is wound on the connecting guide wire 41, and the connecting segment is placed in the second side wall channel 523. The interventional artificial chordae repair device is used to form the implant.

As shown in Figure 5, the method for forming the implant includes the following steps:

1) As shown in Fig. 5a, a part of the artificial tendon cable body is wound around the connecting guide wire 41; when the first collet 51 and the second collet 52 are clamped, the opening of the first side wall channel 522 and the second side wall channel 523 After the openings of the valve are aligned with the two openings of the U-shaped channel 511, the connecting guide wire 41 is pushed in the direction of the arrow shown in the figure to penetrate the second gasket 32, the valve leaflet 6, the first gasket 31 in turn, and enter the U-shaped channel 511;

2) As shown in 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 with the connecting section for guiding; optionally, the connecting guide wire 41 is in the U-shaped channel 511. After penetrating the first gasket 31, the valve leaflet 6 and the second gasket 3 in sequence, they are connected with the connecting section for guiding;

3) As shown in Fig. 5c, the connecting guide wire 41 is withdrawn in the direction of the arrow shown in the figure, and the connecting guide wire 41 will drive the connecting section for guiding, the main body section of the artificial chordae tendineae, and the line section for forming the self-tightening structure to pass through the second gasket 32, After the valve leaflet 6 and the first gasket 31, the self-tightening structure forming line segment is closed at the self-tightening wire knot to form the valve leaflet anchoring ring 122;

4) As shown in Figure 5d, continue to withdraw and connect the guide wire 41, so that the artificial tendon cable body forms a self-tightening knot 121;

5) As shown in Figure 5e, take out the first chuck 51 and the second chuck 52, and tighten the self-tightening knot 121;

6) passing the artificial tendon cord body through the papillary muscle anchoring element 2, making the two movably connected, adjusting the length of the artificial tendon cord body, cutting off the guiding connecting section, and fixing the artificial tendon cord body and the papillary muscle anchoring element 2, The implant is formed.

In the embodiment shown in FIG. 6 , the interventional artificial chord repair device further includes an auxiliary connecting guide wire 42 and an auxiliary connecting wire 43 , and the auxiliary connecting guide wire 42 is detachably connected to the connecting segment for guiding. The auxiliary connecting wire 43 is arranged in the U-shaped channel 511 , one end is detachably connected to the guiding connecting section and/or the auxiliary connecting wire 42 , and the other end is detachably connected to the connecting wire 41 . The setting of the auxiliary connecting guide wire 42 and the auxiliary connecting wire 43 can complete the implantation more quickly.

The detachable connection is selected from snap, magnetic attraction, tenon and tenon, coupling and the like. The function of the auxiliary connection guide wire 42 is to guide the wire segment for forming the self-tightening structure and the main body segment of the artificial chordae tendineae into the U-shaped channel 511 through the guiding connection segment connected at one end.

As shown in FIG. 6 , the auxiliary connecting wire 43 includes a first connecting end 431 and a second connecting end 432 . During implantation, the first connecting end 431 is connected to the connecting guide wire 41 , and the second connecting end 432 is connected to the auxiliary connecting guide wire 42 . connected at one end. Preferably, the connection between the first connection end 431 and the connection guide wire 41 and the connection between the second connection end 432 and the auxiliary connection guide wire 42 are all detachable connections. The function of the auxiliary connecting wire 43 is to help the connecting guide wire 41 to realize the connection with the connecting segment for guiding. Wherein, the auxiliary connecting wire 43 is detachably connected with the guiding connecting section. The detachable connection is selected from snap, magnetic attraction, tenon and tenon, coupling and the like. The auxiliary connecting wire 43 can realize development under DSA, and a developer can be added to the auxiliary connecting wire 43, or a metal wire can be wound, or the connection structure at both ends of the auxiliary connecting wire 43 can be made of metal material.

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

As shown in Figure 7, the method for forming the implant includes the following steps:

1) As shown in Fig. 7a, part of the artificial tendon cable body is wound around the connecting guide wire 41; when the first chuck 51 and the second chuck 52 are clamped, the opening of the first side wall channel 522, the second side wall After the openings of the channel 523 are respectively aligned with the two openings of the U-shaped channel 511, push the connecting guide wire 41 into the U-shaped channel 511 in the direction of the arrow shown in the figure and then connect with the second connection end 432; at the same time, push the auxiliary wire 41 in the direction of the arrow in the figure. The connecting guide wire 42 enters the U-shaped channel 511 and is connected to the first connecting end 431 . At this time, the guiding connecting section is carried by the auxiliary connecting guide wire 42 and enters the U-shaped channel 511 to connect with 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 valve leaflet 6 , and the first gasket 31 in sequence and then enter the U-shaped channel 511 .

2) As shown in Figure 7b, withdraw the connecting guide wire 41 and the auxiliary connecting guide wire 42 in the direction of the arrow shown 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 is connected with the guide Segments remain detachably attached.

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

4) Continue to withdraw the connecting guide wire 41, so that the connecting section for guiding and the body section of the artificial chordae tendineae pass through the self-tightening knot 121.

5) Take out the first chuck 51 and the second chuck 52, and tighten the self-tightening knot 121;

6) Pass the artificial chord body through the papillary muscle anchoring element 2, make the two movably connected, adjust the length of the artificial chord body, cut off the guiding connecting section, and connect the artificial chord body and the papillary muscle anchoring element 2 fixedly .

A fourth aspect of the present application provides the use of the implant, the assembly or the interventional artificial chordae tendineae repair device in the manufacture of a product for treating mitral valve regurgitation.

As shown in FIG. 8 , the steps of using the interventional artificial chordae tendineae repair device are as follows: the delivery system 5 enters the atrium from the atrial septum through the universal sheath ( FIG. 8 a ); Complete valve leaflet clamping with assistance (Figure 8b); release gasket 3 and valve leaflet with self-tightening structure 12, pull back delivery system 5, and withdraw artificial chordae tendineae 1 (Figure 8c); use delivery system 5 to anchor papillary muscle Element 2 is anchored in the myocardium of the left ventricle (Fig. 8d); the delivery system 5 is withdrawn. At this time, the papillary muscle anchoring element 2 is connected to one end of the connecting segment for guidance, and the length of the artificial chordae tendineae is adjusted by ultrasound imaging to ensure no reflux (Fig. 8e). After adjusting the length, cut off the connecting segment for guiding, and the final state of the implant in the heart is shown in Fig. 8f.

The use of the implant or the interventional artificial chordae tendineae repair device can complete the fixation of the artificial chordae tendineae and valve leaflets through an interventional manner, without the need for thoracotomy, with less surgical trauma and quicker recovery of the patient. And the fixation is firm, the valve leaflet is not easily torn, and at the same time, it is conducive to the rapid endothelialization of the implant and the healing of the wound surface.

To sum up, the present invention effectively overcomes various shortcomings in the prior art and has high industrial utilization value.

The above-mentioned embodiments merely illustrate the principles and effects of the present invention, but are not intended to limit the present invention. Anyone skilled in the art can modify or change the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or changes made by those with ordinary knowledge in the technical field without departing from the spirit and technical idea disclosed in the present invention should still be covered by the claims of the present invention.

Claims

An implant, characterized in that the implant comprises an artificial chordae tendineae (1) and a papillary muscle anchoring element (2), the artificial chordae tendineae (1) comprising an artificial chordae tendineae body (11) and a A self-tightening structure (12) is used for the anchoring valve leaflet at one end of the artificial chord body (11), and the other end of the artificial chord body (11) is connected with the papillary muscle anchoring element (2).
The implant according to claim 1, characterized in that the self-tightening structure (12) for anchoring the leaflet comprises a self-tightening wire knot (121) and a leaflet anchoring ring (122), the leaflet anchoring ring (122) Close the loop and lock at the self-tightening wire knot.
The implant according to claim 2, characterized in that, the self-tightening knot (121) is selected from the group consisting of a Bollinger knot, a rope knot, a double bar knot, and a flat knot.
The implant according to claim 2, characterized in that the implant further comprises a spacer (3), and the leaflet anchoring ring (122) penetrates the spacer (3).
The implant according to claim 4, wherein the spacer comprises a first spacer (31) and/or a second spacer (32), and the leaflet anchoring ring (122) is associated with the The first gasket (31) and/or the second gasket (32) are matched and locked through the self-tightening wire knot (121) to form a leaflet anchoring structure.
The implant according to claim 1, characterized in that the papillary muscle anchoring element (2) is in the shape of a helix, a barb-shaped column or a ship-anchor-like shape.
An assembly for forming the implant according to any one of claims 1-6, characterized in that the assembly comprises an artificial chord body and a papillary muscle anchoring element (2), the artificial chord body comprising A guiding connecting segment, an artificial chord body segment and a line segment for forming a self-tightening structure, the artificial chord body is suitable for forming the artificial chord (1) in the implant according to any one of claims 1-6, and can be Optionally, the assembly further includes a gasket.
The assembly of claim 7, wherein the artificial tendon cable body is selected from wires.
The assembly according to claim 7, characterized in that at least one gasket is provided, preferably, the gasket includes a first gasket (31) and a second gasket (32).
The assembly according to claim 7, characterized in that the papillary muscle anchoring element (2) is in the shape of a helical, a barb-shaped column or a ship-anchor-like shape.
The assembly according to claim 7, wherein the free end of the guiding connecting section is provided with a magnetic block, a tenon-and-mortise structure or a buckle structure; preferably, after the implant is formed, the guiding The connecting segment is cut and removed.
An interventional artificial chord repair device, characterized in that the repair device comprises the component according to any one of claims 7-11, a connecting guide wire (41) and a delivery system (5), the connecting guide wire (41) ) is arranged in a delivery system (5), the delivery system (5) is provided with a channel adapted to the artificial tendon cord body in the assembly.
The interventional artificial chord repair device according to claim 12, wherein the connecting guide wire (41) is selected from metal wires; the connecting guide wire (41) is detachably connected to the free end of the connecting segment for guiding .
The interventional artificial chord repair device according to claim 12, wherein the delivery system (5) comprises a first chuck (51) and a second chuck (52), and the first chuck (51) is provided with a U-shaped channel (511), the second chuck (52) is provided with a central channel (521), a first side wall channel (522) and a second side wall channel (523), the first side wall channel (522) One end and one end of the second side wall channel (523) are both communicated with the central channel (521). The two openings of the channel (511) are aligned.
The interventional artificial chord repair device according to claim 14, characterized in that, the interventional artificial chord repair device further comprises an auxiliary connection guide wire (42) and an auxiliary connection wire (43), the auxiliary connection guide wire ( 42) Removably connected with the connecting section for guiding, the auxiliary connecting wire (43) is provided in the U-shaped channel (511), and one end is detachably connected with the connecting section for guiding and/or the auxiliary connecting wire (42) , and the other end is detachably connected with the connecting guide wire (41).
The interventional artificial chord repair device according to claim 13 or 15, wherein the detachable connection is selected from a magnetic attraction connection, a tenon-and-mortise connection or a snap connection.
A method for forming the implant according to any one of claims 1-6, wherein the method for forming comprises the following steps:

1) winding part of the segment of the artificial tendon cable body to connect the guide wire (41);

2) Clamp the first collet (51) and the second collet (52) of the delivery system (5), so that the opening of the first side wall channel (522) provided on the second collet (52) , the openings of the second side wall channel (523) are respectively aligned with the two openings of the U-shaped channel (511) provided on the first chuck;

3) Choose one or two steps from the following:

i. Push the connecting guide wire (41) along the first side wall channel (522), so that the connecting guide wire (41) enters the U-shaped channel (511), and is connected with the guiding connecting segment on the artificial tendon cord body;

ii. Push the auxiliary connection guide wire (42) along the second side wall channel (523) to make the guiding connection section on the artificial tendon cable body and the auxiliary connection wire (43) provided in the U-shaped channel (511) to be in contact with each other. To connect, push the connecting guide wire (41) along the first side wall channel (522), so that the connecting guide wire (41) enters the U-shaped channel (511), connects with the auxiliary connecting wire (43), and withdraws the auxiliary connecting guide wire (42);

4) withdrawing the connecting guide wire (41) so that the artificial tendon cable body forms a self-tightening knot (121) and a leaflet anchoring ring (122);

5) Continue to withdraw the connecting guide wire (41), so that the connecting section for guiding and the body section of the artificial chordae tendineae pass through the self-tightening knot (121);

6) Tighten the self-tightening knot (121);

7) make artificial chord body and papillary muscle anchoring element (2) movably connected, adjust the length of artificial chord body, cut off the guiding connection section, artificial chord body and papillary muscle anchoring element 2 are fixedly connected.
The method for forming an implant according to claim 17, wherein the forming method further comprises the steps of:

a) Before step 2), set the gasket (3) on the open end of the U-shaped channel (511) in the first collet (51) of the delivery system (5), and/or, the second collet (52) ) in the opening of the first side wall channel (522) and the open end of the second side wall channel (523);

b) In step i, the connecting guide wire (41) is pushed along the first side wall channel (522), and the connecting guide wire (41) penetrates the gasket (3) and then enters the U-shaped channel (511) to connect with the artificial tendon cord. The guide on the body is connected with a connecting segment;

c) In step ii, push the auxiliary connection guide wire (42) along the second side wall channel (523), so that it penetrates the gasket (3) and carries the guiding connection section to connect with the auxiliary connection wire (43), along the second side wall channel (523) A side wall channel (522) pushes the connecting guide wire (41), so that the connecting guide wire (41) penetrates the gasket (3) into the U-shaped channel (511), connects with the auxiliary connecting wire (43), and withdraws the auxiliary connecting wire (41). Connect the guide wire (42).
The implant described in any one of claims 1-6, the component described in any one of claims 7-11, or the interventional artificial chordae tendineae repair device described in any one of claims 12-16 is being prepared for the treatment of mitral valve regurgitation use in the product.