A percutaneous transcatheter mitral valve replacement system

Abstract

The present invention relates to a percutaneous transcatheter mitral valve replacement system, belonging to the field of medical device technology. It comprises a valve frame support, artificial valve leaflets and a ventricular septum anchoring structure; a valve frame support is provided between the atrium and the ventricle, and the valve frame support is provided with a hollow cavity with openings at both ends; artificial valve leaflets are provided on the inner wall of the cavity of the valve frame support; and a ventricular septum anchoring structure is provided between the valve frame support and the ventricular septum. In view of the many problems commonly existing in the existing interventional mitral valve systems, such as the valve stent being too large, the risk of left ventricular outflow tract obstruction, and potential complications of the transapical approach and anchoring, the present invention provides a mitral valve replacement device for transcatheter intervention via the femoral vein approach, and provides a technical solution for mitral valve replacement that is more minimally invasive, has a firm anchoring, and can effectively avoid left ventricular outflow tract obstruction.

Description

Technical Field

[0001] The invention relates to a percutaneous transcatheter mitral valve replacement system, belonging to the technical field of medical devices. Background Art

[0002] Mitral valve disease is a common valvular heart disease and the largest group of valvular heart surgery, accounting for about 60%, and mitral regurgitation is the most common mitral valve disease. When the left ventricle of a patient with mitral regurgitation contracts, blood flows through the left ventricle into the aorta, and at the same time, part of the blood enters the left atrium with less resistance through the incomplete mitral valve. In patients with severe regurgitation, the amount of blood flowing into the left atrium can reach more than half of the left ventricular output. The increase in left atrial capacity will lead to an increase in left atrial pressure, which in turn can cause increased pressure, dilation, and congestion in the pulmonary veins and pulmonary capillaries. At the same time, the left ventricular diastolic volume load increases, and the left ventricle enlarges. Patients with long-term mitral regurgitation may develop pulmonary hypertension and total heart failure in the late stage.

[0003] At present, for patients with severe mitral regurgitation who cannot tolerate surgery, mitral valve intervention is the only treatment opportunity. Like open surgical procedures, mitral valve intervention includes transcatheter mitral valve repair and transcatheter mitral valve replacement. Transcatheter mitral valve repair can be divided into three categories: leaflet repair, annulus reduction, and artificial chord implantation. There are two surgical approaches: transfemoral vein and transapical surgical incision. Leaflet repair is based on the "edge-to-edge" principle and is currently the simplest and most mature mitral valve repair technology with relatively the best clinical performance. The use of annulus reduction and artificial chord implantation has its limitations. Transcatheter mitral valve replacement is currently the most competitive direction. There are currently more than 20 different types of interventional mitral valve systems under development worldwide. What is more exciting is that more than 6 valves have entered the clinical stage, and about 200 cases have been completed. However, the various existing interventional mitral valves have more or less defects in design, and there is still a lot of room for improvement and improvement. Currently, the vast majority of transcatheter mitral valve replacement surgical approaches are designed to be transapical. Only the CardiAQ valve from the United States can, in principle, be designed for transapical and transfemoral approaches. So far, there are no products that can be used for transfemoral vein approaches. Summary of the invention

[0004] The purpose of the present invention is to solve the technical problems of various technical defects of mitral valve intervention in the prior art.

[0005] In order to achieve the purpose of solving the above-mentioned problems, the technical solution adopted by the present invention is to provide a percutaneous, transcatheter mitral valve replacement system, including a valve frame support body, artificial valve leaflets and a ventricular septum anchoring structure; a valve frame support body is arranged between the atrium and the ventricle, and the valve frame support body is provided with a hollow cavity with openings at both ends; artificial valve leaflets are arranged on the inner wall of the valve frame support body cavity; a ventricular septum anchoring structure is arranged between the valve frame support body and the ventricular septum.

[0006] Preferably, the horizontal cross-section of the valve frame support body near one end of the atrium is set to a D-shaped structure that matches the closed edges of the anterior leaflet and the posterior leaflet of the mitral valve.

[0007] Preferably, a conical cylindrical skirt structure segment is provided at one end of the valve frame support body close to the atrium, and a cylindrical structure segment is provided at one end of the valve frame support body close to the ventricle.

[0008] Preferably, the cylindrical structural section of the valve frame support body includes an anterior mitral valve leaflet surface and a posterior mitral valve leaflet surface; the anterior mitral valve leaflet surface is provided with a U-shaped arc along the lower edge of the cylindrical structural section of the valve frame support body.

[0009] Preferably, a space for accommodating the anterior leaflet of the mitral valve is provided between the U-shaped arc of the anterior leaflet surface of the mitral valve and the cavity of the cylindrical structural section of the valve frame support body.

[0010] Preferably, a barb structure for hooking the anterior leaflet of the mitral valve is provided on the anterior leaflet surface of the mitral valve of the valve frame support body.

[0011] Preferably, a clip structure for clamping the posterior leaflet of the mitral valve is provided on the posterior leaflet surface of the mitral valve of the valve frame support body.

[0012] Preferably, the valve frame support body is configured as a mesh structure woven from memory alloy wires, and the artificial valve leaflet is configured as a biological or non-biological flexible material.

[0013] The present invention provides a method for using a percutaneous transcatheter mitral valve replacement system, comprising the following steps:

[0014] Step 1: Puncture the femoral vein on one side of the patient, insert the guidewire and puncture sheath into the right atrium, puncture the atrial septum, enter the left ventricle through the mitral valve, and puncture the ventricular septum with the assistance of transesophageal ultrasound guidance to establish a guidewire track from the left ventricle to the right ventricle;

[0015] Step 2: loading the mitral valve replacement system into a corresponding delivery system, delivering the delivery system along a guide wire, and delivering the delivery system into the left ventricle;

[0016] Step 3: Release the ventricular septum anchoring device along the guidewire track from the left ventricle to the right ventricle and withdraw the guidewire;

[0017] Step 4: Under the guidance of transesophageal ultrasound, adjust the direction of the delivery system through the mark on the delivery system so that the mark faces the midpoint of the annular ring of the anterior leaflet of the mitral valve, release the clip on the posterior leaflet of the valve support body, adjust the position so that the clip is fixed to the posterior leaflet of the mitral valve, and continue to release the main body of the valve support body and the skirt structure segment at the atrial end, so that the valve support body is supported at the bottom of the atrium;

[0018] Step 5: Under transesophageal ultrasound monitoring, adjust the length of the anchoring guide wire from the cylindrical structure segment of the valve support to the ventricular septum and fix it;

[0019] Step 6: Withdraw the delivery system of the interventional mitral valve to the left atrium, and insert the atrial septal occluder along the delivery system to occlude the atrial septum and complete the operation.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] The present invention aims to solve the many problems of the existing interventional mitral valve systems, such as the valve stent being too large, the risk of left ventricular outflow tract obstruction, and potential complications of the transapical approach and anchoring, and to provide a mitral valve replacement device that is inserted via a catheter via the femoral vein approach. The device provides a new solution for mitral valve replacement that is more minimally invasive, firmly anchored, and can effectively avoid left ventricular outflow tract obstruction.

[0022] Beneficial effects of the present invention:

[0023] 1. In terms of valve fixation, the anterior leaflet of the mitral valve of the present invention is fixed by barbs, and combined with chordae fixation, the ventricular septum is anchored; the posterior leaflet of the mitral valve is fixed by a clip.

[0024] 2. In terms of preventing left ventricular outflow tract obstruction, the horizontal plane of the valve frame support adopts a D-shaped design, which better fits the mitral valve ring structure; the anterior leaflet frame adopts a U-shaped hollow design to accommodate the anterior leaflet, reducing the obstruction of the valve frame structure cross-section to the left ventricular outflow tract; the anterior leaflet is fixed in a chord-like manner to further reduce the obstruction to the left ventricular outflow tract.

[0025] 3. In terms of access method, the present invention adopts femoral vein access, which is completely different from the currently existing interventional mitral valve replacement system. Most of the existing products adopt transapical access and transfemoral artery access. The present invention is more minimally invasive.

[0026] 4. In preventing paravalvular leakage, the atrial surface of the valve frame support body of the present invention adopts a skirt structure design. The skirt structure is designed to be fluffy or have an outer surface adhesive coating, which can prevent and reduce the occurrence of paravalvular leakage. In addition, by adjusting the tightness of the fixing rope of the ventricular septum anchoring device, the occurrence of paravalvular leakage can be further reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1The present invention is a schematic bottom view of the structure of a percutaneous transcatheter mitral valve replacement system.

[0028] Figure 2 A schematic diagram of the structure of a percutaneous transcatheter mitral valve replacement system.

[0029] Figure 3 A schematic diagram of the structure of a percutaneous transcatheter mitral valve replacement system when it is fixed to the heart.

[0030] Figure numerals: 1. valve frame support body; 2. artificial valve leaflet; 3. ventricular septum anchoring structure; 4. skirt structure segment; 5. U-shaped arc line; 6. barb structure; 7. clip structure. DETAILED DESCRIPTION

[0031] In order to make the present invention more clearly understood, a preferred embodiment is described in detail with reference to the accompanying drawings as follows:

[0032] like Figure 1-3 As shown, the present invention provides a percutaneous transcatheter mitral valve replacement system, including a valve frame support body 1, an artificial valve leaflet 2 and a ventricular septum anchoring structure 3; a valve frame support body 1 is provided between the atrium and the ventricle, and the valve frame support body 1 is provided with a hollow cavity with two ends open; an artificial valve leaflet 2 is provided on the inner wall of the cavity of the valve frame support body 1; and a ventricular septum anchoring structure 3 is provided between the valve frame support body 1 and the ventricular septum. The horizontal cross-section of the valve frame support body 1 near the atrium end is set as a D-shaped structure matching the closed edges of the anterior leaflet and the posterior leaflet of the mitral valve. A conical cylindrical skirt structure segment 4 is provided at one end of the valve frame support body 1 near the atrium, and a cylindrical structure segment is provided at one end of the valve frame support body 1 near the ventricle. The cylindrical structure segment of the valve frame support body 1 includes the anterior leaflet surface of the mitral valve and the posterior leaflet surface of the mitral valve; a U-shaped arc 5 is provided along the lower edge of the cylindrical structure segment of the valve frame support body on the anterior leaflet surface of the mitral valve. A space for accommodating the anterior leaflet of the mitral valve is provided between the U-shaped arc-shaped hollowing of the anterior leaflet of the mitral valve and the cavity of the cylindrical structural section of the valve frame support body 1. The existence of this space will not cause obstruction or displacement of the autologous anterior leaflet of the mitral valve. A barb structure 6 for hooking the anterior leaflet of the mitral valve is provided at the level of the valve ring on the anterior leaflet of the mitral valve of the valve frame support body 1. A clip structure 7 for clamping the posterior leaflet of the mitral valve is provided on the posterior leaflet of the mitral valve of the valve frame support body 1. The valve frame support body 1 is set as a mesh structure woven with memory alloy wire, and the artificial valve leaflet 2 is set as a biological or non-biological flexible material.

[0033] The U-hollowed position on the anterior leaflet of the mitral valve is designed with no less than two tendon chord structures fixed to the ventricular septum.

[0034] The ventricular septum anchoring device can have different structures such as umbrella-shaped, disc-shaped, barbed-shaped, etc.

[0035] A method for using a percutaneous transcatheter mitral valve replacement system comprises the following steps:

[0036] Step 1: Puncture the femoral vein on one side of the patient, insert the guidewire and puncture sheath into the right atrium, puncture the atrial septum, enter the left ventricle through the mitral valve, and puncture the ventricular septum with the assistance of transesophageal ultrasound guidance to establish a guidewire track from the left ventricle to the right ventricle;

[0037] Step 2: loading the mitral valve replacement system into a corresponding delivery system, delivering the delivery system along a guide wire, and delivering the delivery system into the left ventricle;

[0038] Step 3: Release the ventricular septum anchoring device along the guidewire track from the left ventricle to the right ventricle and withdraw the guidewire;

[0039] Step 4: Under the guidance of transesophageal ultrasound, adjust the direction of the delivery system through the mark on the delivery system so that the mark faces the midpoint of the ring of the anterior leaflet of the mitral valve, release the clip 7 on the posterior leaflet of the valve frame support body, adjust the position so that the clip 7 is fixed to the posterior leaflet of the mitral valve, and continue to release the main body of the valve frame support body and the skirt structure segment 4 at the atrial end, so that the valve frame support body 1 is supported at the bottom of the atrium;

[0040] Step 5: Under esophageal ultrasound monitoring, adjust the length of the anchoring guide wire from the cylindrical structure segment of the valve support to the ventricular septum and fix it;

[0041] Step 6: Withdraw the delivery system of the interventional mitral valve to the left atrium, and insert the atrial septal occluder along the delivery system to occlude the atrial septum and complete the operation.

[0042] Surgical procedures:

[0043] Puncture the femoral vein through the atrial septum, puncture the ventricular septum, establish a guidewire track from the left ventricle to the right ventricle, insert the interventional mitral valve replacement device along the guidewire, release the rivet device, withdraw the sheath, release the rivet device of the posterior leaflet of the mitral valve, release the valve, fix the anterior valve ring fixation line, block the atrial septum, and end the operation.

[0044] The above is only a preferred embodiment of the present invention, and is not any formal or substantial limitation of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the present invention, and these improvements and supplements should also be regarded as the protection scope of the present invention. Any technician familiar with this profession, without departing from the spirit and scope of the present invention, can make some changes, modifications and equivalent changes made by using the technical content disclosed above, which are equivalent embodiments of the present invention; at the same time, any changes, modifications and evolutions of any equivalent changes made to the above embodiments based on the essential technology of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. A percutaneous transcatheter mitral valve replacement system, characterized in that: It includes a valve frame support body, an artificial valve leaflet and a ventricular septum anchoring structure; a valve frame support body is arranged between the atrium and the ventricle, and the valve frame support body is provided with a hollow cavity with two ends opened; an artificial valve leaflet is arranged on the inner wall of the cavity of the valve frame support body; and a ventricular septum anchoring structure is arranged between the valve frame support body and the ventricular septum; The horizontal cross section of the valve frame support body close to one end of the atrium is set to a D-shaped structure that matches the closed edges of the anterior leaflet and the posterior leaflet of the mitral valve; The valve frame support body is provided with a cylindrical structure section at one end close to the ventricle; The cylindrical structure section of the valve frame support body includes a mitral valve front leaflet surface and a mitral valve rear leaflet surface; the mitral valve front leaflet surface is provided with a U-shaped arc along the lower edge of the cylindrical structure section of the valve frame support body; A space for accommodating the anterior leaflet of the mitral valve is provided between the U-shaped arc-shaped hollowing of the anterior leaflet surface of the mitral valve and the cavity of the cylindrical structural section of the valve frame support body; The U-shaped hollow position of the anterior leaflet of the mitral valve is provided with no less than two tendon chord structures fixed to the position of the ventricular septum; The end of the valve frame support body close to the atrium is provided with a conical cylindrical skirt structure section.

2. A percutaneous transcatheter mitral valve replacement system as claimed in claim 1, characterized in that: A barb structure for hooking the anterior leaflet of the mitral valve is provided on the anterior leaflet surface of the mitral valve of the valve frame support body.

3. A percutaneous transcatheter mitral valve replacement system as claimed in claim 1, characterized in that: A clip structure for clamping the posterior leaflet of the mitral valve is provided on the posterior leaflet surface of the mitral valve of the valve frame support body.

4. A percutaneous transcatheter mitral valve replacement system as claimed in claim 1, characterized in that: The valve frame support body is set as a mesh structure woven by memory alloy wires, and the artificial valve leaflet is set as a biological or non-biological flexible material.

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