WO2020047968A1

WO2020047968A1 - Artificial mitral valve intervention replacement device and intervention method thereof

Info

Publication number: WO2020047968A1
Application number: PCT/CN2018/112710
Authority: WO
Inventors: 谭雄进; 潘湘斌
Original assignee: 谭雄进
Priority date: 2018-09-07
Filing date: 2018-10-30
Publication date: 2020-03-12
Also published as: CN109009569B; CN109009569A

Abstract

Provided is an artificial valve intervention replacement device applied to mitral insufficiency, comprising a supporting body (1) and artificial valves (2), the lower edge of the supporting body (1) is a conical cylinder structure with a D-shaped cross section, multiple stopping ropes (4) are arranged in the supporting body (1), and the multiple artificial valves (2) are connected to the lower edge and can move along with motion of the natural valve (3) of a patient. The intervention replacement device does not affect the functions of the left chamber outflow channel and the aortic valve, the function of the natural valve (3) of the mitral valve is reserved, the natural blood flow is used for driving the artificial valve (2) and the aortic valve (3) to move in the same direction, and the artificial valve (2) can be completely closed at the contraction period to prevent backflow of the mitral valve.

Description

Artificial mitral valve intervention replacement device and intervention method

Technical field

The invention belongs to the field of biomedical instruments, and particularly relates to an artificial mitral valve intervention replacement device and an intervention method thereof.

Background technique

Mitral regurgitation (MR) is a common heart valve disease, and the basic pathological change is mitral regurgitation. When the left ventricle contracts, blood flow is injected into the aorta from the left ventricle and enters the left atrium with less resistance through the insufficiency of the mitral valve, and the return flow into the left atrium can reach more than 50% of the left ventricular output. Increased left atrial pressure can cause increased pressure in the pulmonary veins and swollen capillaries, followed by dilation and congestion. At the same time, the left ventricular diastolic volume load increases, and the left ventricle enlarges. Pulmonary hypertension and total heart failure may occur in patients with mitral regurgitation at an advanced stage.

At present, all mitral valve prostheses in the prior art need to be anchored to the ventricular surface by an anchoring structure, and fixed to the ventricular surface through barbed or hook structures. For example, the application publication number is CN105287050A, and the name is "transcatheter mitral valve prosthesis." "Patent document, the technical solution of which is:" Radial expansion of the ventricular skirt may include anchoring the posterior ventricular anchoring ears to the posterior leaflet of the natural mitral valve so as to seat between the posterior leaflet and the ventricular wall of the heart. The ventricular skirt may include multiple barbs, and expanding the ventricular skirt may include anchoring the barbs into the heart tissue; "this anchoring method may cause ventricular damage, which can cause death in severe cases. Another example is an application for a patent document with publication number CN201711162783 entitled "Mitral valve parking device, system and method", as shown in Figure 10-12. The spiral anchor is provided with a hook bracket for fixing the anchor. This kind of fixation will also cause ventricular damage. In the prior art, the principle of using three curved leaflets to expand and close each other under the impact of blood flow is generally used. This closing mode must use biological materials, such as bovine pericardium and porcine heterogeneous valves, because non-biological artificial synthesis The material will undergo fatigue deformation during the closing process of long-term blood flow impact expansion, and small deformation will cause the three valve leaflets to be inadequately mated, which will cause reflux. The use of biological materials has a heterogeneous risk, and it is bound to be in the long run. Calcification causes valve failure, and the existing artificial biological valve has a service life of about ten years.

In addition, the existing mitral valve anchoring devices squeeze the natural leaflets on the side wall of the ventricle, and replace the natural leaflets with artificial leaflets, so that the natural leaflets completely lose their own functions.

Summary of the Invention

In order to overcome the above problems, the present invention provides a mitral valve interventional replacement device that supports a smooth external surface without barbs without damaging the ventricle, and retains the natural leaflet function. The natural leaflet drives the artificial leaflet opening and closing. In the open state, it does not affect the blood entering the left ventricle, and in the closed state of the artificial valve leaflet, it can be completely closed to prevent mitral valve regurgitation.

The present invention provides the following technical solutions:

An artificial mitral valve interventional replacement device includes a support body and an artificial leaflet. The cross section of the lower edge of the support body is a "D" shape. Connect several artificial leaflets. Further, the support body is a deformable material, and the artificial leaflet is a biotic or abiotic flexible material.

Further, the support body is a mesh structure woven by a memory alloy wire.

Further, the artificial leaflet has a first end and a free end, the first end is connected to the lower edge of the support body, the free end is opposite to the first end, and there is an opening between the artificial leaflets Configuration and closed configuration;

The diastolic artificial leaflets are in the open configuration, and the free ends of the artificial leaflets are away from each other and enter the left ventricle to allow antegrade blood to flow through the opening between the leaflets;

The left ventricular systolic artificial valve leaflets are in the closed configuration, and the free ends of the artificial valve leaflets move in the direction of the left atrium, mating with each other to close the support body to prevent retrograde blood flow.

Further, the plurality of blocking cables are arranged on the same plane, or each blocking cable is recessed in the direction of the left ventricle to form two or more mating planes, or is arranged in a scattering shape in the support body to form a tapered surface with the connection point as a center.

Further, the upper edge of the support body is supported in the left atrium above the mitral valve annulus, the artificial valve leaflets sag into the ventricle and can move with the movement of the natural valve leaflets.

Further, the upper edge of the support body is round, oval-like, or D-shaped or a special shape customized to fit the left atrium space structure of the patient's mitral valve according to the CT image of the patient. When the upper edge opening is oval-like The opening has a long diameter of 10-400mm, a short diameter of 10-400mm, a support body height of 1-200mm, a lower edge opening of D-shape, a straight edge length of 8-200mm, a transverse diameter of 8-200mm, and various diameters of the upper edge opening. The lines are 2-100 mm larger than the diameter of the lower edge opening, and the length of the artificial leaflets is 5-100 mm.

Further, a polyester cloth is partially or entirely provided on the outer surface of the support body to close the pores on the surface of the support body, a fleece-like leak-proof tape is attached to the outer surface of the polyester cloth, or an adhesive coating is coated on the outer surface of the polyester cloth.

Further, a plurality of fixing lines are provided on the outside of the support body, the fixing lines extending to the outside of the apex of the bottom of the ventricle, and the fixing lines are connected and fixed to each other outside the apex to prevent the support body from being displaced in the left atrium direction.

Further, the fixing line is connected at the vertex of the straight edge of the lower edge opening of the support body.

Further, an anchoring structure is provided on the outside of the support body for fixing the support body at the mitral valve annulus.

An interventional method for an artificial mitral valve interventional replacement device includes the following steps:

Step 1: Puncture the apex, and send the catheter and guide wire from the left ventricle into the left atrium through the mitral valve opening;

Step 2: The artificial mitral valve interventional replacement device is installed in a corresponding delivery system, and is guided along the guide wire into the delivery system. After the delivery system is delivered into the left atrium, the guide wire is withdrawn from the body;

Step 3: Under the guidance of ultrasound, adjust the direction of the delivery system through the mark on the delivery system so that the mark faces the midpoint of the anterior mitral valve annulus to ensure that the artificial leaflet corresponds to the natural valve leaflet position. The natural leaflets move in the same direction, releasing the support, supporting the upper edge of the support at the bottom of the left atrium, above the mitral valve annulus, and the lower edge of the support inside the mitral valve annulus;

Step 4 Exit the delivery system. The several fixed lines connected to the support are located in the delivery system. As the delivery system exits the heart and emerges from the puncture point, pull down the fixed line, fine-tune the position of the artificial valve by adjusting the length of the fixed line, and pull. The force is used to fix the artificial valve, the fixation wire is connected to the gasket, and a knot is tied outside the apex of the heart to fix the support.

With the above technical solution, the present invention has the following beneficial effects:

1. The artificial mitral valve interventional replacement device of the present invention is fixed in the left atrium above the mitral valve opening, and the lower edge of the support body is a "D" shape, which is compatible with the shape of the mitral valve opening, and the external surface of the support is smooth. No anchoring structure is needed, which will not cause damage to myocardium, leaflets and other tissues;

2. The upper edge of the support body of the present invention can be round, oval or D-shaped, and can also be customized according to the CT image of the patient to a special shape suitable for the left atrium space structure above the mitral valve of the patient, so that the support body is D-shaped. After the edge is inserted into the annulus, the upper part of the support body can fit closely with the left atrium of the patient.

3. The artificial mitral valve intervention replacement device of the present invention does not squeeze the support body to the natural leaflet, the natural leaflet retains its function, and the artificial leaflet moves with the movement of the natural leaflet, and the artificial leaflet closed configuration is guaranteed Blood will not return

4. The artificial mitral valve intervention replacement device of the present invention does not need to provide artificial chordae fixed to the ventricle for the artificial valve leaflets, and the blocking ropes provided on the upper part of the support body prevent the leaflets from floating upward, thereby improving the safety of the interventional replacement apparatus.

5. The present invention adopts the structure combination of artificial leaflets and blocking cables, and uses blocking wires to help the artificial valve to close. As long as the length of the leaflets is sufficient, the valve can be effectively closed to prevent backflow, and the deformation of the leaflet materials cannot affect the blocking of the valve. The effect overcomes the technical problem that the artificial valve leaf is deformed in the prior art to generate a gap that causes blood to return. Furthermore, the present invention can use non-biological materials such as plastic to manufacture the valve. Thanks to the durability and anti-calcification of non-biological materials, The interventional valve can be used for a long time and has a longer life than the existing biological valve.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a bottom view of the support of the artificial mitral valve interventional replacement device;

2 is a schematic structural diagram of a support body of an artificial mitral valve intervention replacement device;

2 is a schematic structural diagram of an artificial valve leaflet of a support body of an artificial mitral valve intervention replacement device;

4 is a state diagram of the use of the artificial mitral valve interventional replacement device above the interventional mitral valve annulus;

5 is a schematic structural diagram of a fixed line of an artificial mitral valve interventional replacement device.

Of which: 1-support body, 2-artificial leaflet, 3-natural leaflet, 4-blocking cord

detailed description

In order to make the objectives, technical solutions, and advantages of the present invention clearer, the present invention is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the structural diagrams and specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

Example 1

An artificial mitral valve interventional replacement device, as shown in FIG. 1-3, includes a support body 1 and an artificial valve leaflet 2. The upper edge opening of the support body is circular, oval-like, or D-shaped or set according to the CT image of the patient. In order to adapt to the special shape of the left atrium space structure above the mitral valve of the patient, the cross section of the lower edge is a "D" shape, and the cone structure is gradually reduced from upper to lower perimeter. The lower edge of the support body is connected with several artificial valve leaves. After the D-shaped lower edge of the support body of the invention is embedded in the annulus, the upper part of the support body can closely fit the left atrium of the patient.

The support body is a deformable material. Preferably, the support body may be a mesh structure woven by a memory alloy wire, or may be other materials capable of elastic deformation, and can be used in a transport system when used.

When the opening at the upper edge is quasi-elliptical, the long diameter of the opening is 10-400mm, the short diameter is 10-400mm, the height of the support body is 1-200mm, the lower edge opening is D-shaped, the straight edge length is 8-200mm, and the transverse diameter is 8 ～ 200mm, the diameter of the upper edge opening is 2-100mm larger than the diameter of the lower edge opening, and the length of the artificial leaflet is 5-100mm. Different types are set according to the length of the straight edge and the transverse diameter of the lower edge of the support body, such as 24-30mm, 26-32mm, 28-32mm, etc. The clinician can choose a suitable device according to the degree of mitral annulus expansion of the patient.

Preferably, a part or all of the outer surface of the support body is sewn with a polyester cloth to close the pores on the surface of the support body. A fluff-like leak-proof tape is attached to the outer surface of the polyester cloth, or an outer surface of the polyester cloth is coated with an adhesive coating. It is made of felt sheet, polyester sheet and other materials. It is used to increase the degree of fit between the support body and the mitral valve annulus and the inner surface of the heart, and it is closely adhered to the atrial wall to prevent perivalvular leakage.

Artificial valve leaflets can be tissues such as pericardium or valves of cattle and pigs, or non-biological flexible materials, which can float and oscillate along the blood stream. For example, materials such as plastic do not have calcification without biological origin, and can be used for a long time.

The present invention does not limit the number of artificial leaflets, and may be two, three or more, and the artificial leaflets may be the same or different in shape and size. It is preferable that the shape of the artificial leaflet is similar to that of the natural leaflet. The anterior leaflet is curtain-shaped and is located in a linear portion of the D-shape. The attachment part of the anterior leaflet accounts for about 1/3 of the entire annulus circumference. The posterior leaflet It is a long strip, located in the D-shaped arc, and the attachment part of the posterior leaflet occupies about 2/3 of the entire annulus circumference.

The artificial leaflet has a first end and a free end, the first end is connected to the support body, the free end is opposite to the first end, and the artificial leaflet has an open configuration and a closed configuration;

The diastolic artificial leaflets are in an open configuration, with the free ends of each artificial leaflet away from each other and entering the left ventricle to allow antegrade blood to flow through the opening between the leaflets;

The left ventricular systolic artificial valve leaflets are in a closed configuration, and the free ends of the artificial valve leaflets move toward the left atrium, mating with each other to form a mating edge with the closed support body to prevent retrograde blood flow.

Example 2

As shown in Figure 4-5, preferably, the upper edge of the support body is supported in the left atrium above the mitral valve annulus, and the artificial valve leaflets sag into the ventricle and can move with the natural valve leaflet movement.

A plurality of blocking cables 4 are arranged in the support body to prevent the leaflets from excessively floating to the left atrium, so that the artificial leaflets are mutually joined at the plane of the blocking cables. The present invention does not limit the structure and position of the arresting cable, and the structures capable of preventing the leaflets from floating beyond the opening of the upper edge of the support should be understood as the arrangement manner of the arresting cable of the present invention. For example, several arresting cables can be parallel to each other and arranged on the same plane, or each arresting cable is recessed in the direction of the left ventricle to form two or more mating planes, or is scattered in the support body to form a cone with the connection point as the center. surface.

There are several fixed lines on the outside of the support, which extend to the outside of the apex of the bottom of the ventricle. The fixed lines on the outside of the apex are connected and fixed to each other to prevent the support from being displaced in the left atrial direction. Preferably, the fixing line is connected at the vertex of the straight edge of the lower edge of the support body opening.

The interventional replacement device of the present invention can be compressed and packed into a delivery sheath, implanted into the body through the left ventricular apical interventional path, and the support body is fixed in the mitral valve annulus and the left atrium after release, relying on the support force and the fixation through the apex The wire is fixed to the support body. During the diastole, the artificial leaflets are pushed open by the natural leaflets from top to bottom under the impact of blood flow and sag into the left ventricle. Both the artificial mitral valve and the natural mitral valve are opened and contract in the left ventricle. In the current period, the natural leaflets are lifted from the bottom to the artificial leaflets under the impact of blood flow. Under pathological conditions, the natural leaflets still regurgitate after being closed, and the artificial leaflets are closed tightly by the blocking cord to block the regurgitation. Flow of blood for therapeutic purposes.

The support body of the present invention may be fixed in other ways, such as adding an anchoring structure on the outside of the support body for fixing the support body at the mitral valve annulus. The shape of the anchoring structure is not limited here. For example, Chinese Patent Publication No. CN 104771247 A, "A device and method for treating mitral regurgitation" uses the "clamping" produced by the atrium flange 22 and the annulus support 24. Effect "; for example, Chinese Patent Publication No. CN 107405194 A," Mitral valve prosthesis "anchoring element and hook structure.

The mitral valve interventional device of this fixing method is inserted through the femoral vein into the right atrium and punctured into the left atrium during the intervention. It is released from top to bottom, and the interventional device is fixed to the root of the mitral valve leaflet by an anchoring structure. It is not necessary to provide an anchoring structure when implanting the mitral valve interventional device of the present invention via the apex.

Example 3

Step 1. Puncture the apex, and send the catheter and guide wire from the left ventricle into the left atrium through the mitral opening;

Step 3: Under the guidance of ultrasound, adjust the direction of the delivery system through the mark on the delivery system so that the mark faces the midpoint of the anterior mitral valve annulus to ensure that the artificial leaflet corresponds to the natural valve leaflet position. The natural leaflets move in the same direction, release the support, support the upper part of the support at the bottom of the left atrium, above the mitral valve annulus, and the lower edge of the support is located inside the mitral valve annulus;

Step 4: Withdraw from the delivery system. The several fixed wires connected to the support are located in the delivery system. As the delivery system exits the heart and emerges from the puncture point, pull down the fixed line, fine-tune the position of the artificial valve by adjusting the length of the fixed line, and by pulling The force is used to fix the artificial valve, the fixation wire is connected to the gasket, and a knot is tied outside the apex of the heart to fix the support.

The device can also be used to treat patients with mitral stenosis, or patients with mitral stenosis and mitral regurgitation. These patients first use the apex or femoral vein to puncture the atrial septum, and then use a balloon to expand the mitral valve. The mitral valve leaflet is fully expanded. At this time, the mitral valve stenosis is relieved, but the mitral valve insufficiency occurs due to the tearing of the valve leaflets. The device can be implanted according to the method described above to treat the mitral valve insufficiency.

The above-mentioned embodiment only expresses the implementation manner of the present invention, and its description is more specific and detailed, but it cannot be understood as a limitation on the scope of the patent of the present invention. It should be noted that, for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can be made, which all belong to the protection scope of the present invention. Therefore, the protection scope of the invention patent shall be subject to the appended claims.

Claims

An artificial mitral valve interventional replacement device includes a support body and an artificial leaflet, characterized in that the cross-section of the lower edge of the support body is a "D" shape, and the support body gradually tapers from the upper to the lower perimeter. The tube structure is connected with several artificial leaflets at the lower edge of the support body.
The artificial mitral valve interventional replacement device according to claim 1, wherein the support body is a deformable material, and the artificial valve leaf is a biological or non-biological flexible material.
The artificial mitral valve interventional replacement device according to claim 2, wherein the support body is a mesh structure woven by a memory alloy wire.
The artificial mitral valve interventional replacement device according to claim 1, wherein the artificial valve leaflet has a first end and a free end, and the first end is connected to the lower edge of the support body, and the free end The end is opposite to the first end, and there is an open configuration and a closed configuration between artificial leaflets;

The diastolic artificial leaflets are in the open configuration, and the free ends of the artificial leaflets are away from each other and enter the left ventricle to allow antegrade blood to flow through the opening between the leaflets;

The left ventricular systolic artificial valve leaflets are in the closed configuration, and the free ends of the artificial valve leaflets move in the direction of the left atrium, mating with each other to close the support body to prevent retrograde blood flow.
The artificial mitral valve interventional replacement device according to claim 1, characterized in that a plurality of blocking cables are provided in the support body to prevent the leaflets from excessively floating to the left atrium, and the artificial valve leaves are joined to each other on the blocking cable surface .
The artificial mitral valve interventional replacement device according to claim 1, wherein the plurality of arresting cables are arranged on the same plane, or each of the arresting cables is recessed in the direction of the left ventricle to form two or more mating planes, or The connection point is used as a center to form a conical surface in a scattering form.
The artificial mitral valve intervention replacement device according to claim 5, wherein the upper edge of the support body is supported in the left atrium above the mitral valve annulus, and the artificial valve leaf sags into the ventricle and can follow the natural The leaflets move.
The artificial mitral valve interventional replacement device according to claim 1, characterized in that the upper edge opening of the support body is circular, oval-like, D-shaped or customized according to the CT image of the patient to adapt to the upper left of the patient's mitral valve The shape of the atrium space structure, when the upper edge opening is quasi-elliptical, the long diameter of the opening is 10-400mm, the short diameter is 10-400mm, the height of the support body is 1-200mm, the lower edge opening is D-shaped, and the length of the straight edge is 8 -200mm, transverse diameter is 8 ～ 200mm, each diameter line of the upper edge opening is 2-100mm larger than the diameter line of the lower edge opening, and the length of the artificial leaflet is 5-100mm.
The artificial mitral valve interventional replacement device according to claim 1, wherein a part or all of the outer surface of the support body is provided with a polyester cloth to close the pores on the surface of the support body, and an outer surface of the polyester cloth is attached with a fluff-like anti-flood Missing tape or polyester cloth with an adhesive coating on the outside surface.
The artificial mitral valve replacement device according to claim 1, wherein a plurality of fixing lines are provided on the outside of the support body, the fixing lines extending to the outside of the apex of the ventricle bottom, and the fixing lines on the outside of the apex of the heart are mutually The connection is fixed to prevent the support from being displaced toward the left atrium.
The artificial mitral valve interventional replacement device according to claim 10, wherein the fixed line is connected at the vertex of the straight edge of the lower edge of the support.
The artificial mitral valve interventional replacement device according to claim 1, wherein an anchoring structure is provided on the outside of the support body for fixing the support body at the mitral valve annulus.
The interventional method for an artificial mitral valve replacement device according to claim 10, further comprising the following steps:

Step 1: Puncture the apex, and send the catheter and guide wire from the left ventricle into the left atrium through the mitral valve opening;

Step 2: The artificial mitral valve interventional replacement device is installed in a corresponding delivery system, and is guided along the guide wire into the delivery system. After the delivery system is delivered into the left atrium, the guide wire is withdrawn from the body;

Step 3: Under the guidance of ultrasound, adjust the direction of the delivery system through the mark on the delivery system so that the mark faces the midpoint of the anterior mitral valve annulus to ensure that the artificial leaflet corresponds to the natural valve leaflet position. The natural leaflets move in the same direction, releasing the support, supporting the upper edge of the support at the bottom of the left atrium, above the mitral valve annulus, and the lower edge of the support inside the mitral valve annulus;

Step 4: Withdraw from the delivery system. The several fixed wires connected to the support are located in the delivery system. As the delivery system exits the heart and emerges from the puncture point, pull down the fixed line, fine-tune the position of the artificial valve by adjusting the length of the fixed line, and by pulling The force is used to fix the artificial valve, the fixation wire is connected to the gasket, and a knot is tied outside the apex of the heart to fix the support.