A method of mitral valve intervention valve fixation operation

Abstract

The application provides a method for fixing an interventional valve on a mitral valve, which comprises the following steps: driving a plurality of fixing nails into the left atrial side wall above the mitral valve; and connecting a fixing disc on the atrial septum through a connecting line to form a plurality of fixing lines above the mitral valve. The fixing method can form a plurality of fixing lines above the mitral valve, and the fixing lines can provide stable fixing support for the interventional valve implanted below, thereby effectively solving the problem that the current interventional mitral valve is difficult to be stably anchored, and the method for fixing the interventional valve on the mitral valve is simple and convenient to operate.

Description

Technical Field

[0001] This invention relates to the medical field, and more specifically, to a method for mitral valve interventional valve fixation. Background Technology

[0002] The mitral valve is a sheet-like structure attached to the periphery of the left atrium and left ventricle, connected to the papillary muscles by chordae tendineae. It acts as a one-way valve, preventing blood from flowing back from the left ventricle to the left atrium. Mitral regurgitation is a common heart condition. Severe mitral regurgitation can cause left ventricular enlargement, ultimately leading to left ventricular systolic dysfunction and heart failure, as well as left atrial enlargement, atrial fibrillation, and pulmonary hypertension. Surgical intervention is currently the primary treatment for mitral regurgitation, but it has drawbacks such as significant trauma, numerous complications, and high mortality. In recent years, transcatheter valve replacement (TCV) has become a hot topic in cardiac interventional device research due to its minimally invasive nature and high safety. Currently, domestic and international researchers have designed and developed several mitral valve replacement devices, but most are still in the exploratory stage, and a considerable number of designs have been proven infeasible. Researchers in this field are still dedicated to developing transcatheter mitral valves that are clinically feasible, safe, and effective. The biggest challenge in designing transcatheter atrioventricular valves is achieving stable valve anchoring and ease of operation. Therefore, there is an urgent need for a technical solution that can stably anchor the mitral valve prosthesis and facilitate its implantation in order to address the above problems. Summary of the Invention

[0003] The purpose of this invention is to provide a method for mitral valve fixation via interventional procedures, thereby solving the problem of unstable anchoring of the mitral valve in current interventional procedures.

[0004] In a first aspect, embodiments of the present invention provide a method for mitral valve interventional valve fixation, comprising the following steps:

[0005] Several fixation pins were driven into the left atrial lateral wall above the mitral valve;

[0006] A series of fixed lines are formed above the mitral valve by connecting them to a fixed plate located on the interatrial septum via connecting wires.

[0007] In some embodiments, the step of driving a plurality of fixation pins into the left atrial lateral wall above the mitral valve is performed using a nailing device.

[0008] In some embodiments, the method further includes the step of delivering a delivery sheath to the left atrium.

[0009] In some embodiments, the method further includes the step of feeding the fixing nail and the nailer through the delivery sheath.

[0010] In some embodiments, the method further includes the step of discharging the connecting wire connected to the fixing pin from the delivery sheath.

[0011] In some embodiments, the connection to the fixed plate located on the interatrial partition via connecting wires specifically includes: threading all connecting wires through the central mesh of the fixed plate.

[0012] In some embodiments, all connecting wires are threaded through the central mesh of the fixation plate, and the fixation plate is released at the interatrial septum along the connecting wires and the delivery sheath; the fixation wires are tightened so that the connecting wires between the fixation pins and the fixation plate are taut, and then the connecting wires are knotted at the fixation plate using a knotter and cut using a wire cutter.

[0013] In some embodiments, the method further includes the step of retracting the delivery sheath, thereby completing the formation of several fixation lines above the mitral valve.

[0014] The above-mentioned fixation method can create several fixation lines above the mitral valve. These fixation lines can provide a stable fixation support for the implanted interventional valve below, which can effectively solve the problem of the current difficulty in the stable anchoring of the interventional mitral valve. Moreover, this mitral valve interventional valve fixation operation method is simple and convenient to operate. Attached Figure Description

[0015] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0016] Figure 1 A three-dimensional structural diagram of the fixing pin of the mitral valve interventional valve fixation device provided in an embodiment of the present invention;

[0017] Figure 2 This is a schematic diagram of the planar structure of the fixation pin of the mitral valve interventional valve fixation device provided in an embodiment of the present invention;

[0018] Figure 3 A three-dimensional structural schematic diagram of the screw-driving component of the mitral valve interventional valve fixation device provided in an embodiment of the present invention;

[0019] Figure 4 This is a schematic diagram of the assembly of the fixing pin and the nailing device of the mitral valve interventional valve fixation device according to an embodiment of the present invention. Detailed Implementation

[0020] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0021] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0022] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0023] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0024] Please refer to the reference. Figures 1 to 4 The mitral valve interventional valve fixation device provided in this embodiment includes a fixation nail 1, a nailer 2, a fixation disc, a connecting wire, a knotter, a wire cutter, and a delivery sheath.

[0025] The fixing pin 1 includes a spiral pin 1-1 and a fixing head 1-2. The spiral pin 1-1 is fixed to the proximal end of the fixing head 1-2. The fixing head 1-2 includes a spiral section at the proximal end and a spiral section at the distal end. The spiral section has a thin sheet structure.

[0026] Spiral needle 1-1 is a spiral needle with a sharp tip, which can be made of rigid materials such as metal.

[0027] The fixing head 1-2 is cylindrical in shape, comprising a proximal section for fixing the spiral needle 1-1, a central spiral section 1-2-2, and a distal section 1-2-1 for attaching to the spiral needle. The spiral needle 1-1 is fixed to the proximal section of the fixing head 1-2 and extends proximally. The spiral section 1-2-2 has an external thread structure, which matches the internal thread on the inner wall of the outer tube 2-1 of the nail driver. The outer diameter of this section is equal to or greater than the outer diameter of the spiral needle 1-1.

[0028] The rotating section 1-2-1 is a rectangular thin sheet structure that matches the groove 2-2-1 structure set near the center end of the rotary pusher 2-2 of the nailer 2. By rotating the rotary pusher 2-2, the rotating section 1-2-1 is driven to rotate, which in turn drives the entire fixing nail 1 (including the spiral needle) to rotate, and the spiral needle 1-1 can then be inserted into the human tissue.

[0029] The rotating section 1-2-1 is also provided with a wiring hole 1-2-3, through which the connecting wire is connected to the fixing head 1-2. The fixing head 1-2 can be made of metal materials such as stainless steel, or it can be made of rigid polymer materials.

[0030] The nailer 2 includes an outer tube 2-1 and a rotary pusher 2-2. Both the outer tube 2-1 and the rotary pusher 2-2 are long tubular structures that extend from the heart area to the outside of the body through blood vessels during operation.

[0031] The inner wall of the outer tube 2-1 is provided with an internal thread that mates with the helical section. The proximal end of the rotary pusher 2-2 is configured with a groove structure that mates with the rotating section (thin sheet structure) and drives the fixing nail 1 to rotate. In the initial state, the fixing nail 1 is fully fitted into the outer tube 2-1. During nailing, by rotating the rotary pusher 2-2 externally, its rotating section drives the fixing nail 1 to rotate, causing it to rotate out of the outer tube 2-1 proximal to the outer tube 2-1. At the same time, the helical needle 1-1 of the fixing nail 1 can be driven into the target tissue. After completion, the rotating section disengages from the groove of the fixing nail 1, that is, the nailer 2 is released from the fixing nail 1.

[0032] The fixing plate is a double-plate structure made of shape memory alloy wire braided and heat-set. One end of the connecting wire is connected to the fixing nail 1, and the other end is knotted and connected to the sealing plate. The connecting wire is knotted by the knotter and cut by the wire cutter.

[0033] Specifically, the fixed plate is a double-plate, one-waist I-shaped structure made of shape memory alloy wire braided and heat-set, similar to the room partition occluders currently used in clinical practice.

[0034] The connecting wire is made of polymer materials such as nylon, polyethylene, and polypropylene, or metal materials such as nickel-titanium wire, stainless steel wire, and tantalum wire. The connecting wire is connected to the fixing head 1-2. The rotating section has a wiring hole for fixing the connecting wire. The rotating push part 2-2 has a through hole for the connecting wire to pass through, and the connecting wire exits through this through hole and runs to the outside.

[0035] One end of the connecting wire is connected to the fixing head 1-2 through the wiring hole, and the other end is a free end, but it is connected to the fixing plate after being knotted by the knotter. The connecting wire is knotted by the knotter and then cut by the wire cutter.

[0036] The fixing pin 1 and the connecting wire are paired in a 1:1 ratio, and one fixing plate can be connected to several fixing pins 1 and connecting wires.

[0037] The knotter and thread cutter can be implemented using existing technologies, and the specific implementation methods are not unique, so they will not be elaborated here.

[0038] The delivery sheath is a tubular structure used to transport the various structural components mentioned above to the target location.

[0039] The aforementioned mitral valve interventional valve fixation device can perform mitral valve interventional valve fixation, and its fixation method includes the following steps:

[0040] S1. The delivery sheath is delivered through the femoral vein to the right atrium, and then through the interatrial septum to the left atrium.

[0041] S2. Insert the fixation nail 1 and the nailing device 2 through the delivery sheath, and operate the nailing device 2 to nail the fixation nail 1 to the left atrial lateral wall above the mitral valve.

[0042] S3. Drive in several fixing pins 1, and pull the connecting line connected to the fixing pins 1 along the delivery sheath tubing to the outside of the body.

[0043] S4. Thread all connecting wires through the central mesh of the mounting plate, and release the mounting plate at the interatrial septum along the connecting wires and delivery sheath.

[0044] S5. Tighten the fixing line to make the connecting line between the fixing nail 1 and the fixing plate taut. Then, use a knotter to tie the connecting line at the fixing plate and use a wire cutter to cut it.

[0045] S6. Withdraw the delivery sheath to complete the surgery, thus creating several fixation lines above the mitral valve.

[0046] The mitral valve interventional valve fixation device provided in this embodiment can use a nailer 2 to nail several fixation nails 1 into the left atrial lateral wall (including the valve annulus) above the mitral valve, and then connect them to the fixation plate located on the interatrial septum through connecting lines. In this way, several fixation lines are formed above the mitral valve, which can provide a stable fixation support for the interventional valve implanted below.

[0047] Subsequent interventional valves do not require complex anchoring structures; a simple stent-like structure suffices, and valve anchoring is not a concern, thus simplifying the valve implantation procedure. Therefore, the mitral valve interventional valve fixation device provided in this embodiment offers a technical solution that provides stable anchoring for interventional mitral valve implantation while facilitating its placement.

[0048] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A mitral valve interventional valve fixation device, characterized in that, include: A fixed plate, several fixing nails, and corresponding 1:1 matching connecting wires; The plurality of fixation pins are driven into the left atrial lateral wall above the mitral valve; the fixation plate is located on the interatrial septum; one end of each of the connecting lines is connected to the plurality of fixation pins, and the other end is connected to the same fixation plate, forming a plurality of fixation lines above the mitral valve, which can provide fixed support for the mitral valve interventional valve implanted below it.

2. The mitral valve interventional valve fixation device according to claim 1, characterized in that, Also includes: A nailing device suitable for driving the aforementioned fixing nails into the left atrial lateral wall above the mitral valve.

3. The mitral valve interventional valve fixation device according to claim 2, characterized in that, Also includes: A delivery sheath suitable for conveying the plurality of fixing pins and nailers to the left atrium.

4. The mitral valve interventional valve fixation device according to claim 3, characterized in that, The fixed plate is released at the interatrial septum along the connecting line and the delivery sheath.

5. The mitral valve interventional valve fixation device according to claim 1, characterized in that, The fixed disk is a double-disc structure made of shape memory alloy wire braided and then heat-set.

6. The mitral valve interventional valve fixation device according to claim 1, characterized in that, Also includes: A knotter suitable for knotting the connecting wire that passes through the central mesh of the fixed plate at the fixed plate.

7. The mitral valve interventional valve fixation device according to claim 6, characterized in that, Also includes: A wire cutter suitable for cutting the connecting wire that has been knotted at the fixed plate.

8. The mitral valve interventional valve fixation device according to claim 1, characterized in that, The fixing pin includes a spiral needle and a fixing head. The spiral needle is fixed to the proximal end of the fixing head. The fixing head includes a spiral section at the proximal end and a spiral section at the distal end. The spiral section has a thin sheet structure.

9. The mitral valve interventional valve fixation device according to claim 8, characterized in that, The spiral section has an external thread structure, which matches the internal thread on the inner wall of the outer tube of the nailer suitable for nailing the plurality of fixing pins into the left atrial sidewall above the mitral valve. The outer diameter of this section is equal to or greater than the outer diameter of the spiral needle.

10. The mitral valve interventional valve fixation device according to claim 1, characterized in that, The connecting lines between the plurality of fixing nails and fixing discs are tightened.

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