CN109009569B

CN109009569B - Artificial mitral valve intervention replacement device and intervention method thereof

Info

Publication number: CN109009569B
Application number: CN201811044198.8A
Authority: CN
Inventors: 潘湘斌; 谭雄进
Original assignee: Individual
Current assignee: Individual
Priority date: 2018-09-07
Filing date: 2018-09-07
Publication date: 2020-08-04
Anticipated expiration: 2038-09-07
Also published as: WO2020047968A1; CN109009569A

Abstract

The artificial valve intervention and replacement device for mitral insufficiency comprises a support body and artificial valve leaflets, wherein the lower edge of the support body is of a cone-shaped structure with a D-shaped cross section, a plurality of arresting ropes are arranged in the support body, and the lower edge of the support body is connected with the artificial valve leaflets and can move along with the natural valve leaflets of a patient. The intervention replacement device does not influence the functions of a left ventricular outflow tract and an aortic valve, retains the functions of the natural valve leaflet of the mitral valve, drives the artificial valve leaflet and the natural valve leaflet to move in the same direction through natural blood flow, and can completely close the artificial valve leaflet in a contraction period to prevent the mitral valve from flowing backwards.

Description

Artificial mitral valve intervention replacement device and intervention method thereof

Technical Field

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

Background

Mitral insufficiency (MR) is a common valvular heart disease with the underlying pathology changing to mitral Regurgitation. When the left ventricle contracts, blood flows from the left ventricle into the aorta and enters the left atrium with less resistance through the incompetent mitral valve, and the return flow into the left atrium can reach more than 50% of the left ventricle blood discharge. An increase in left atrial pressure may cause an increase in pulmonary vein and oncocapillary pressure, which in turn dilates and extravasates. Simultaneously, the diastolic volume load of the left ventricle is increased, and the left ventricle is enlarged. Pulmonary hypertension and total heart failure can occur in advanced stages of patients with mitral insufficiency.

The mitral valve prostheses in the prior art are anchored on the ventricular surface by an anchoring structure and fixed to the ventricular surface by a barb or hook structure, for example, patent document CN105287050A entitled "transcatheter mitral valve prosthesis", which has the following technical solutions: "radially expanding the ventricular skirt may include anchoring the posterior ventricular anchoring tab to the posterior leaflet of the native mitral valve so as to seat between the posterior leaflet and the ventricular wall of the heart. The ventricular skirt may comprise a plurality of barbs, and expanding the ventricular skirt may comprise anchoring the barbs into heart tissue "; the anchoring device can cause ventricular injury, and can cause death in severe cases. As another example, in patent document CN201711162783 entitled "mitral valve parking device, system and method", fig. 10-12, a hook-shaped bracket is provided on a helical anchor for fixing the anchor, which also causes ventricular damage. In the prior art, the working principle that three arc-shaped valve leaflets expand under blood flow impact and are closed mutually is adopted, biological materials such as bovine pericardium and porcine heterogeneous valves are required to be used in the closing mode, and due to the fact that the non-biological artificial synthetic materials can generate fatigue deformation in the closing process of long-term blood flow impact expansion, the three valve leaflets are not closed tightly due to tiny deformation, backflow occurs, the biological materials are used, the heterogeneous risk exists, calcification is inevitably generated in a long term, valve failure is caused, and the service life of the conventional artificial biological valve is about ten years.

In addition, existing mitral valve anchors compress the natural leaflets against the ventricular sidewall, replacing them with artificial leaflets, which completely lose their function.

Disclosure of Invention

In order to overcome the problems, the invention provides a mitral valve intervention replacement device with a smooth and unbarbed outer surface of a support body, which does not damage a ventricle, and keeps the function of a natural valve leaflet, so that the natural valve leaflet drives an artificial valve leaflet to open and close, the artificial valve leaflet does not influence blood to enter a left ventricle in an open state, and the artificial valve leaflet can be completely closed to prevent mitral valve regurgitation in a closed state.

The invention provides the following technical scheme:

the utility model provides a prosthetic mitral valve intervenes replacement device, includes supporter and artificial valve leaf, supporter lower edge cross section is "D" type, and the taper cylinder structure that the girth gradually reduces from top to bottom connects a plurality of artificial valve leaf at the supporter lower edge. Furthermore, the support body is made of deformable materials, and the artificial valve leaflet is made of biological or non-biological flexible materials.

Furthermore, the support body is a net structure woven by memory alloy wires.

Further, the artificial valve leaflet is provided with a first end and a free end, the first end is connected with the lower edge of the support body, the free end is opposite to the first end, and the artificial valve leaflet is provided with an open configuration and a closed configuration;

the diastolic artificial leaflets being in the open configuration, the free ends of the respective artificial leaflets moving away from each other into the left ventricle to allow antegrade blood to flow through the openings between the leaflets;

the left ventricular systole artificial valve leaflets are in the closed configuration, the free ends of the artificial valve leaflets move towards the left atrium direction, the artificial valve leaflets are mutually combined to close the support body, and retrograde blood is prevented from flowing through the support body.

Furthermore, the plurality of arresting cables are arranged on the same plane, or each arresting cable is sunken towards the left chamber to form two or a plurality of involutory planes, or are scattered by taking the connecting point as the center and arranged in the support body to form a conical surface.

Further, the upper edge of the support rests within the left atrium above the mitral annulus, and the prosthetic leaflet sags into the ventricle and is able to move with the natural leaflet.

Furthermore, the upper edge of the support body is circular, elliptical or D-shaped or is customized to be a special shape adapted to the spatial structure of the left atrium above the mitral valve of a patient according to the CT image of the patient, when the opening at the upper edge is 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 opening at the lower edge is D-shaped, the length of the straight edge is 8-200mm, the transverse diameter is 8-200mm, the radial lines of the opening at the upper edge are respectively 2-100mm larger than the radial lines of the opening at the lower edge, and the length of the artificial valve leaflet is 5-100 mm.

Furthermore, the outer surface of the support body is partially or completely provided with terylene cloth to seal the pores on the surface of the support body, and the outer surface of the terylene cloth is attached with a villiform leakproof belt or is coated with an adhesive coating.

Furthermore, a plurality of fixing lines are arranged on the outer side of the supporting body, the fixing lines extend to the outer side of the apex of the heart at the bottom of the ventricle, and the fixing lines are fixedly connected with each other on the outer side of the apex of the heart to prevent the supporting body from moving towards the left atrium.

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

Further, an anchoring structure is arranged outside the support body and used for fixing the support body at the mitral valve annulus.

An interventional method of a prosthetic mitral valve interventional replacement device, comprising the steps of:

firstly, puncturing an apex, and conveying a catheter and a guide wire from a left ventricle to a left atrium through a mitral valve opening;

step two, the artificial mitral valve intervention replacement device is arranged into a corresponding conveying system, the conveying system is conveyed along the guide wire, and the guide wire is withdrawn from the body after the conveying system is conveyed into the left atrium;

under the guidance of ultrasonic waves, the direction of the conveying system is adjusted through the mark on the conveying system, so that the mark faces the midpoint of the anterior valve annulus of the mitral valve, the position of the artificial valve leaflet is ensured to correspond to the position of the natural valve leaflet, the artificial valve leaflet can move in the same direction with the natural valve leaflet, the support body is released, the upper edge of the support body is supported at the bottom of the left atrium, the upper side of the mitral valve annulus is positioned above the mitral valve annulus, and the lower edge of the support body is positioned;

and step four, withdrawing the conveying system, wherein a plurality of fixing wires connected with the support body are positioned in the conveying system, are exposed from the puncture point along with the withdrawal of the conveying system from the heart, pull down the fixing wires, finely adjust the position of the artificial valve by adjusting the length of the fixing wires, fix the artificial valve by pulling force, connect the fixing wires on the gasket, knot the outside of the apex of the heart and fix the support body.

By adopting the technical scheme, the invention has the following beneficial effects:

1. the artificial mitral valve intervention replacement device is fixed in the left atrium above the opening of the mitral valve, the lower edge of the support body is D-shaped and is adaptive to the shape of the opening of the mitral valve, the outer surface of the support body is smooth, an anchoring structure is not needed, and the tissue injuries of cardiac muscle, valve leaflets and the like are avoided;

2. the upper edge of the support body can be circular, oval or D-shaped, and can be customized into a special shape suitable for the spatial structure of the left atrium above the mitral valve of a patient according to the CT image of the patient, so that the upper part of the support body can be tightly attached to the left atrium of the patient after the D-shaped lower edge of the support body is embedded into the valve ring.

3. According to the artificial mitral valve intervention replacement device, the support body cannot extrude natural valve leaflets, the natural valve leaflets retain the functions of the natural valve leaflets, the artificial valve leaflets move along with the movement of the natural valve leaflets, and the closed configuration of the artificial valve leaflets ensures that blood cannot flow back;

4. the artificial mitral valve intervention replacement device does not need to arrange artificial chordae tendineae fixed on the ventricle for the artificial valve leaflets, and the arresting cords arranged on the upper part of the support body prevent the valve leaflets from floating upwards excessively, so that the safety of the intervention replacement device is improved.

5. The invention adopts the structural combination of the artificial valve leaflet and the arresting cable, the arresting cable is used for helping the artificial valve to close, the valve can be effectively closed to prevent backflow as long as the length of the valve leaflet is enough, the deformation of the valve leaflet material cannot influence the effect of the arresting cable for closing the valve, the technical problem that the artificial valve leaflet deforms to generate a gap to cause blood backflow in the prior art is solved, and then the invention can use non-biological materials such as plastics to manufacture the valve, and the intervention valve can be used for a long time and has longer service life than the prior biological valve due to the durability and calcification resistance of the non-biological materials.

Drawings

FIG. 1 is a bottom view of a prosthetic mitral valve interventional replacement device support;

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

fig. 3 is a structural diagram of a prosthetic mitral valve intervention replacement device support prosthetic leaflet;

FIG. 4 is a view of the use of a prosthetic mitral valve intervention replacement device above the annulus of the mitral valve;

fig. 5 is a structural diagram of a fixing wire of the artificial mitral valve intervention replacement device.

Wherein: 1-support body, 2-artificial valve leaf, 3-natural valve leaf and 4-arresting cable

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in further detail with reference to the accompanying drawings and embodiments. It should be understood that the block diagrams and specific examples are set forth only for the purpose of illustrating the invention and are not to be construed as limiting the invention.

Example 1

An intervention and replacement device for a mitral valve prosthesis comprises a support body 1 and a prosthetic valve leaflet 2, wherein an opening on the upper edge of the support body is circular, elliptical or D-shaped or is set to be a special shape adapted to a spatial structure of the left atrium above the mitral valve of a patient according to a CT image of the patient, the cross section of the lower edge of the support body is D-shaped, the circumference of the lower edge of the support body is gradually reduced from top to bottom, and the lower edge of the support body is connected with a plurality of prosthetic valve leaflets. After the D-shaped lower edge of the support body is embedded into the valve ring, the upper part of the support body can be tightly attached to the left atrium of a patient.

The support body is made of deformable materials, preferably, the support body can be a net structure woven by memory alloy wires, or other materials capable of generating elastic deformation, and the support body can be taken into the conveying system when in use.

When the opening on the upper edge is in an ellipse-like shape, 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 opening on the lower edge is D-shaped, the length of the straight edge is 8-200mm, the transverse diameter is 8-200mm, the radial lines of the opening on the upper edge are respectively 2-100mm larger than the radial lines of the opening on the lower edge, and the length of the artificial valve leaflet is 5-100 mm. According to the straight edge length and the transverse diameter of the opening of the lower edge of the support body, different models are arranged, such as 24-30mm, 26-32mm, 28-32mm and the like, and a clinician can select a proper device according to the expansion degree of the mitral valve annulus of a patient.

Preferably, the outer surface of the support body is partially or completely sewn with terylene cloth to close the pores on the surface of the support body, and the outer surface of the terylene cloth is adhered with a villous leakage-proof belt or is coated with an adhesive coating, such as a felt sheet and a terylene sheet, which is used for increasing the attaching degree of the support body with the mitral valve ring and the inner surface of the heart, and is tightly adhered with the atrial wall to prevent perivalvular leakage.

The artificial valve leaf can be the pericardium or valve tissue of cattle and pig, or can be the non-biological flexible material, which can float and swing along the blood flow. For example, the material such as plastic has no biological origin and can not be calcified, and the material can be used for a long time.

The number of the artificial valve leaflets is not limited, and the number of the artificial valve leaflets can be 2, 3 or more, and the artificial valve leaflets can be in the same shape and size or in different sizes. Preferably, the shape of the artificial leaflet is similar to that of a natural leaflet, wherein the anterior leaflet is curtain-shaped and located on a straight line part of a D shape, the attachment part of the anterior leaflet occupies 1/3 about the whole annulus circumference, the posterior leaflet is strip-shaped and located on an arc part of the D shape, and the attachment part of the posterior leaflet occupies 2/3 about the whole annulus circumference.

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

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

the left ventricle systole artificial valve leaf is in closed configuration, the free end of each artificial valve leaf moves towards the left atrium direction, and the closed support bodies are mutually jointed to form a joint edge, thereby preventing retrograde blood from flowing through.

Example 2

As shown in fig. 4-5, the upper edge of the support body is preferably supported within the left atrium above the mitral annulus, and the prosthetic leaflet sags into the ventricle and is able to move with the natural leaflet motion.

A plurality of arresting ropes 4 are arranged in the supporting body to prevent the valve blades from floating to the left atrium excessively, so that the artificial valve blades are mutually jointed on the plane of the arresting ropes. The structure and the position of the arresting cable are not limited, and the structure capable of preventing the valve leaflets from floating up to exceed the upper edge opening of the support body is understood as the arrangement mode of the arresting cable. For example, the plurality of arresting cords may be parallel to each other and disposed on the same plane, or each arresting cord may be recessed toward the left chamber to form two or more involutory planes, or may be disposed in a scattering manner around the connection point to form a cone in the support body.

The supporter outside is equipped with a plurality of fixed lines, and the fixed line extends to the ventricle bottom apex of heart outside, and fixed line interconnect is fixed in the apex of heart outside, prevents the supporter to the room direction displacement left. Preferably, the fixing line is connected at the vertex of the straight edge of the opening of the lower edge of the support body.

The intervention replacement device can be compressed and arranged in a conveying sheath, is implanted into a body through a left ventricle apex intervention way, the support body is fixed in a mitral valve ring and a left atrium after being released, the support body is fixed by means of support force and a fixing line penetrating out of the apex, the artificial valve leaflet pushes away natural valve leaflets from top to bottom under the impact of blood flow and sags into the left ventricle during diastole, the artificial mitral valve and the natural mitral valve are both opened, the natural valve leaflets lift the artificial valve leaflets from bottom to top under the impact of the blood flow during systole of the left ventricle, the natural valve leaflets still return after being closed, and the artificial valve leaflets close tightly under the obstruction of an obstruction cable to block the returned blood in a pathological state, thereby achieving the treatment purpose.

The support body of the invention can be fixed by other means, such as additionally arranging an anchoring structure at the outer side of the support body for fixing the support body at the mitral valve annulus. Without limitation to the shape of the anchoring structure, such as chinese patent publication No. CN 104771247 a, "a device and method for treating mitral regurgitation" utilizes the "clamping effect" created by the atrial flange 22 and the annular support 24; for example, chinese patent publication No. CN 107405194 a, "anchoring element and hook structure of mitral valve prosthesis", etc.

The mitral valve intervention device adopting the fixing method is inserted into the right atrium through the femoral vein and then penetrates the interatrial septum to enter the left atrium, and the intervention device is released from top to bottom and fixed at the root of the mitral valve leaflet by the anchoring structure. The mitral valve access device of the present invention does not require the placement of an anchoring structure for transapical implantation.

Example 3

firstly, puncturing the cardiac apex, and conveying a catheter and a guide wire into the left atrium from the left ventricle through openings of the two apices;

under the guidance of ultrasonic waves, the direction of the conveying system is adjusted through the mark on the conveying system, so that the mark faces the midpoint of the anterior valve annulus of the mitral valve, the position of the artificial valve leaflet is ensured to correspond to the position of the natural valve leaflet, the artificial valve leaflet can move in the same direction with the natural valve leaflet, the support body is released, the upper part of the support body is supported at the bottom of the left atrium, the upper part of the mitral valve annulus is positioned above the mitral valve annulus, and the lower edge of the support body is positioned;

The device can also be used for treating mitral stenosis or patients with mitral stenosis combined with mitral insufficiency, wherein the patients firstly puncture the interatrial space through the apex of the heart or the femoral vein, then use the balloon to expand the mitral valve and completely expand the valve leaflets of the mitral valve, at the moment, the mitral stenosis is relieved, but the mitral insufficiency appears due to the tearing of the valve leaflets, and then the device can be implanted for treating the mitral insufficiency according to the method.

The above-mentioned embodiments only express the embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the present invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. An artificial mitral valve intervention replacement device comprises a support body and artificial valve leaflets, and is characterized in that the cross section of the lower edge of the support body is D-shaped, the circumference of the support body is gradually reduced from top to bottom, a plurality of arresting cables are arranged in the support body to prevent the valve leaflets from excessively floating towards the left atrium, the artificial valve leaflets are mutually jointed on the surfaces of the arresting cables, the artificial valve leaflets are connected to the lower edge of the support body, the artificial valve leaflets are provided with a first end and a free end, the first end is connected with the lower edge of the support body, the free end is opposite to the first end, and the artificial valve leaflets are in an open configuration and a closed configuration; the outer surface of the support body is partially or completely provided with terylene cloth to seal pores on the surface of the support body, and a villiform leakproof belt is attached to the outer surface of the terylene cloth or the outer surface of the terylene cloth is coated with a viscous coating to prevent the leakage around the valve;

the left ventricular systole artificial valve leaflets are in the closed configuration, the free ends of the artificial valve leaflets move towards the left atrium direction, the closed support bodies are mutually closed together with the help of the arresting ropes, and retrograde blood is prevented from flowing through.

2. The interventional replacement device of claim 1, wherein the support body is a deformable material and the prosthetic leaflet is a biological or non-biological flexible material.

3. The interventional replacement device of claim 1, wherein the support is a mesh structure woven from memory alloy wire.

4. The interventional replacement device for a mitral valve prosthesis of claim 1, wherein the plurality of retaining cables are disposed in the same plane, or each retaining cable is recessed toward the left ventricle to form two or more involutory planes, or are disposed in a scattering manner around the connection point to form a cone in the support.

5. The interventional replacement device of claim 3, wherein the upper edge of the support body is supported within the left atrium above the mitral valve annulus, and wherein the prosthetic leaflet sags into the ventricle and is capable of moving with the movement of the native leaflet.

6. The interventional replacement device for a mitral valve prosthesis according to claim 1, wherein the upper edge opening of the support body is circular, oval-like, D-shaped or customized according to CT images of a patient to fit the left atrial spatial structure above the mitral valve of the patient, when the upper edge opening is oval-like, the opening has a longer diameter of 10-400mm, a shorter diameter of 10-400mm, a height of the support body of 1-200mm, the lower edge opening is D-shaped, the straight edge has a length of 8-200mm, and a transverse diameter of 8-200mm, each radial line of the upper edge opening is correspondingly 2-100mm larger than that of the lower edge opening, and the length of the prosthetic leaflet is 5-100 mm.

7. The device for interventional replacement of a mitral valve according to claim 1, wherein a plurality of fixing wires are provided on the outside of the support body, the fixing wires extend to the outside of the apex of the ventricle at the bottom of the ventricle, and the fixing wires are fixedly connected with each other on the outside of the apex of the ventricle to prevent the support body from being displaced toward the left atrium.

8. The interventional replacement device of claim 7, wherein the fixation line is attached at the apex of the straight edge of the opening of the lower rim of the support body.

9. The interventional replacement device of claim 8, wherein an anchoring structure is provided on an outer side of the support body for securing the support body at the mitral valve annulus.