A rail-mounted mitral valve prosthesis implantation system and method of operating the same

Abstract

The application discloses a track type mitral valve prosthesis implantation system and an operation method thereof, and relates to the medical field. The track type mitral valve prosthesis implantation system comprises a mitral annular space annuloplasty device, a biological ring and a mitral valve prosthesis stent. The annuloplasty device comprises a first deformable delivery wire and a second deformable delivery wire. A magnetic force ball to be captured is fixed to an end of the first deformable delivery wire, and a magnetic force ball to be captured is fixed to an end of the second deformable delivery wire. The first / second deformable delivery wire is used for forming a guide channel through mutual attraction of the magnetic force balls with different magnetic properties. The biological ring is in the shape of a strip when freely stretched. Two free ends of the biological ring are configured to be locked to form a biological ring locking buckle when a main body part of the biological ring is pushed along the guide channel. The mitral valve prosthesis stent is a radially self-expanding tubular body. The mitral valve prosthesis stent comprises a stent top lotus layer, a stent middle recess layer and a stent bottom support layer which are connected in communication. Left / right ear-shaped anchoring members are arranged on the stent bottom support layer.

Description

Technical Field

[0001] This invention relates to a transcatheter mitral valve prosthesis stent and valve implantation method, and particularly to a track-type mitral valve prosthesis implantation system and its operation method. Background Technology

[0002] With the aging population trend in my country, the incidence of valvular degenerative diseases in the elderly is constantly increasing, among which mitral valve disease leads to a gradual decline in left ventricular function. For patients with severe mitral valve disease, surgical mitral valve replacement was once the only treatment that could prolong life, but elderly patients are often contraindicated for surgery due to advanced age, weak constitution, severe disease, or other comorbidities. For high-risk patients or those with contraindications to cardiac surgery, transcatheter mitral valve implantation can now be considered an effective treatment option.

[0003] Mitral valve replacement is a cardiac surgery that replaces the diseased or abnormal mitral valve with an artificial valve. Its main indications include mitral stenosis, severe valve calcification, or mitral regurgitation. Current methods have the following main problems: unreliable anchoring and inadequate sealing after mitral valve implantation; expansion and deformation of the mitral valve stent compressing the left ventricular outflow tract, and the existing anterior valve partially obstructing blood flow, thus causing left ventricular outflow tract obstruction.

[0004] Therefore, there is an urgent need for a system and method to solve problems such as firm anchoring, reliable sealing, and smooth passage during mitral valve implantation. Summary of the Invention

[0005] In view of the technical problems existing in the prior art, this application provides a track-type mitral valve prosthesis implantation system.

[0006] A track-type mitral valve prosthesis implantation system, including

[0007] The mitral valve annular space ring-forming device includes a first deformable conveying wire and a second deformable conveying wire. One end of the first deformable conveying wire is fixed with a magnetic ball to be captured, and one end of the second deformable conveying wire is fixed with a capturing magnetic ball with a magnetic dissimilarity to the magnetic ball to be captured. The first deformable conveying wire or the second deformable conveying wire is used to form a ring-shaped guide channel under the mutual attraction of magnetic balls with dissimilarity.

[0008] A biological ring, which is strip-shaped when freely extended, has two free ends configured to lock together when the main body of the biological ring is pushed along the guide channel to form a biological ring locking buckle;

[0009] The mitral valve prosthesis stent is a radially self-expanding tubular body. The mitral valve prosthesis stent includes a connected top lotus layer, a middle recessed layer, and a bottom support layer. The bottom support layer is provided with left / right ear-shaped anchors. The middle recessed layer is fixed within the bio-ring.

[0010] As a further improvement, the first deformable conveyor wire and the second deformable conveyor wire are made of shape memory metal.

[0011] As a further improvement, the bio-ring has a through hole along its length for the passage of the first / second deformable conveying wire; the two ends of the bio-ring are respectively set as a bio-ring locking tip and a bio-ring locking ring, the bio-ring locking tip has an external thread, and the bio-ring locking ring has an internal thread adapted to the external thread, the bio-ring locking tip is used to enter the bio-ring locking ring to form the bio-ring locking buckle.

[0012] As a further improvement, the front end of the bio-ring locking tip is configured as a tip structure, and the outer periphery of the rear end has the external thread; one side of the thread tooth of the external thread of the bio-ring locking tip is at 30° with its central axis, and one side of the thread tooth of the internal thread of the bio-ring locking ring is at 30° with its central axis.

[0013] As a further improvement, the left / right ear-shaped anchors are provided with multiple barbs in their respective circumferential directions;

[0014] The left / right ear-shaped anchors are ear-shaped pieces that extend radially outward from the mitral valve prosthesis stent, and their orientation is set to be upward.

[0015] As a further improvement, a front leaflet of the top lotus layer is provided at the front end of the top lotus layer of the support, and a left fiber triangular area alignment element and a right fiber triangular area alignment element are respectively provided on the top lotus layer of the support on the left and right sides of the front leaflet of the top lotus layer. The left / right ear-shaped anchors are provided on the bottom support layer of the support corresponding to the position of the front leaflet of the top lotus layer.

[0016] The angle between the filamentous material forming the anterior leaflet of the top lotus layer and the central axis of the mitral valve prosthesis stent is 10°, and the angle between the filamentous material forming the top lotus layer of the stent and the central axis of the mitral valve prosthesis stent is 45°.

[0017] As a further improvement, the system also includes a valve adapted to the mitral valve prosthesis stent, and the mitral valve prosthesis stent and the mitral valve prosthesis valve are connected by a prosthesis valve suture support strip, the shape of which is consistent with the outer contour of the mitral valve prosthesis valve.

[0018] This application also discloses a mitral valve prosthesis stent, which is a radially self-expanding tubular body, including a connected stent top lotus layer, a stent middle recessed layer and a stent bottom support layer; a left ear-shaped anchor and a right ear-shaped anchor are provided on the stent bottom support layer.

[0019] As a further improvement, a front leaflet of the top lotus layer is provided at the front end of the top lotus layer of the support. Left / right fiber triangular alignment elements are respectively provided on the top lotus layer of the support on the left and right sides of the front leaflet of the top lotus layer. The left ear-shaped anchor and the right ear-shaped anchor are provided on the bottom support layer of the support below the front leaflet of the top lotus layer. The left ear-shaped anchor and the right ear-shaped anchor are provided with multiple barbs in their respective circumferential directions.

[0020] As a further improvement, the system also includes a laser cutter or blade. Preferably, the laser cutter includes a laser transmission fiber, a conversion connector, an angle adjustment section, a connector, a blade head, and an angle adjustment line. The laser transmission fiber is connected to the angle adjustment section via the conversion connector, and the angle adjustment section is connected to the blade head via the connector. All connections are threaded and can be sealed. The two ends of the angle adjustment line are fixedly connected to the outer walls of the conversion connector and the connector, respectively, to facilitate blade angle adjustment.

[0021] This application also discloses a method for operating the system, including:

[0022] Step 1): Creating a guideable channel for the biological ring: Using an external catheter delivery system, the deformable delivery wire sheath and the mitral valve annular space ring-forming device are placed into the mitral valve annular space. Under the guidance of the deformable delivery wire sheath, the second deformable delivery wire and the first deformable delivery wire are advanced in the mitral valve annular space. The capturing magnetic ball and the magnetic ball to be captured attract each other to form a capture buckle joint. Thus, the first deformable delivery wire forms a guideable channel in the shape of a ring around the root of the mitral valve leaflet.

[0023] Step 2): Insertion of the bio-ring to form a ring structure around the root of the mitral valve: Push the bio-ring along the channel described in Step 1) to lock the two ends of the bio-ring to form a bio-ring locking buckle. At this point, the bio-ring is inserted into the ring space at the root of the mitral valve, and the bio-ring surrounds the root of the mitral valve.

[0024] Step 3): Mitral valve prosthesis delivery and placement: The compressed mitral valve prosthesis stent is delivered to the left atrium via the apex or septum, the mitral valve prosthesis stent is released, and its central recessed layer is fixed in the bio-ring.

[0025] The following is a further explanation of this application:

[0026] In a first aspect, this application provides a bio-ring insertion system for mitral valve prosthesis fixation, comprising a bio-ring (300), wherein the bio-ring has a through hole in its circumferential direction for passage of a first deformable delivery wire, the bio-ring (300) comprising a bio-ring locking tip (301), a bio-ring locking ring (304), a first bio-ring (302), and a second bio-ring (303), the adjacent ends of the first bio-ring (302) and the second bio-ring (303) being integrally connected, the front end of the bio-ring locking tip (301) having a pointed structure, the rear end having an external thread on its outer periphery, and the rear end of the bio-ring locking tip being fixedly connected to one end of the first bio-ring (302), the bio-ring locking ring (304) being... One end is fixedly connected to the end of the second bio-ring. The inner wall of the bio-ring locking ring (304) is provided with an internal thread, which is adapted to the external thread at the rear end of the bio-ring locking tip. Under the guidance of the annular body, the bio-ring locking tip (301) and the bio-ring locking ring (304) are respectively pushed and locked by the first bio-ring (302) and the second bio-ring (303) to form a bio-ring locking buckle, thereby forming a bio-ring surrounding the root of the original mitral valve leaflet. The annular body is formed by the first deformable conveying wire surrounding the root of the original mitral valve leaflet. The bio-ring insertion system provided in this application has an adjustable diameter of bio-ring, which can more reliably fix and seal the mitral valve prosthesis.

[0027] As a further improvement, in the bio-ring insertion system, one side of the external thread at the rear end of the bio-ring locking tip (301) forms a 30° angle with the central axis, and one side of the internal thread of the bio-ring locking ring (304) forms a 30° angle with its central axis. In this application, the external thread at the rear end of the bio-ring locking tip and the internal thread of the bio-ring locking ring are matched and both set at 30°, which makes it easier for the bio-ring locking tip to enter the bio-ring locking ring, facilitating operation by the operator.

[0028] As a further improvement, in the aforementioned bio-ring placement system, the annular body is formed by a mitral valve annular space ring-forming device. This device includes a capturing magnetic ball 101, a magnetic ball to be captured 104, a first deformable delivery wire 103, and a second deformable delivery wire 105. The top end of the first deformable delivery wire is fixedly connected to the magnetic ball to be captured, and the capturing magnetic ball 101 is fixedly connected to the end of the second deformable delivery wire 105. The magnetic ball to be captured 104 is used to capture the capturing magnetic ball 101 to form a capture buckle connector, and after forming the capture buckle connector, it is pulled out of the body along with the second deformable delivery wire through the catheter system, so that the first deformable delivery wire forms an annular body surrounding the root of the original mitral valve leaflet. The annular structure designed in this application is ingenious. By setting the capturing magnetic ball and the magnetic ball to be captured to form a capture buckle connector, the first deformable delivery wire can easily wrap around the root of the mitral valve leaflet, which facilitates subsequent shearing and also provides guidance for bio-ring placement.

[0029] As a further improvement, in the aforementioned biological ring insertion system, the capturing magnetic ball and the magnetic ball to be captured have opposite poles attracting each other, so that the two can attract and connect and fix themselves smoothly after entering the mitral valve annular space, thereby enabling the operator to operate accurately and quickly to complete the preparation work for biological ring insertion and mitral valve shearing.

[0030] Secondly, this application provides a mitral valve prosthesis stent, which is a radially self-expanding tubular body. After the mitral valve prosthesis stent is released, it is fixed by the biological ring in the above-mentioned biological ring placement system. The mitral valve prosthesis stent includes a lotus-shaped layer (401) at the top of the stent, a recessed layer (402) in the middle of the stent, and a support layer (403) at the bottom of the stent.

[0031] The top lotus layer (401) of the support is formed by connecting multiple lotus petal-like filaments to form an annular flange. At the front end of the top lotus layer (401) of the support, there is a small leaf (409) formed by multiple lotus petal-like filaments. On the left and right sides of the top lotus layer (401) of the support, there are left fiber triangular area alignment elements (406) and right fiber triangular area alignment elements (405). On the bottom support layer (403) of the support corresponding to the position of the small leaf (409) of the top lotus layer, there are left ear-shaped anchors (407) and right ear-shaped anchors (408).

[0032] As a further improvement, in the mitral valve prosthesis stent, the angle between the filaments that make up the anterior leaflet (409) of the top lotus layer and the central axis of the mitral valve prosthesis stent (400) is 10°, and the angle between the filaments that make up the top lotus layer (401) of the stent and the central axis of the mitral valve prosthesis stent (400) is 45°.

[0033] The recessed layer (402) in the middle of the support is formed by connecting triangular filaments. The diameter of the flange formed by the connection of the triangular filaments is smaller than the diameter of the lotus layer (401) at the top of the support, so as to form a recessed annular groove.

[0034] The bottom support layer (403) of the support is made of triangular filaments connected together, and the diameter of the flange formed by the connection of the triangular filaments is larger than the diameter of the recessed layer (402) in the middle of the support.

[0035] The left ear-shaped anchor (407) and the right ear-shaped anchor (408) are ear-shaped pieces that extend radially outward from the support, and their direction is set to tilt upward toward the atrium; the left ear-shaped anchor and the right ear-shaped anchor are respectively provided with multiple barbs downward in the circumferential direction;

[0036] The top lotus layer (401), the middle recessed layer (402), and the bottom support layer (403) of the support are connected and supported by columnar filaments.

[0037] Thirdly, this application provides a track-mounted mitral valve prosthesis implantation system, comprising:

[0038] Ring formation: The first deformable conveying wire is formed into a ring that surrounds the root of the original mitral valve leaflet, and the diameter of the ring is adjustable;

[0039] Shearing: Using a laser cutter or a sharp blade, the anterior leaflet is cut from a position away from the central axis of the mitral valve annulus to a position close to the central axis of the mitral valve annulus to obtain a mitral valve slit;

[0040] Bio-ring insertion: The bio-ring insertion system guides an adjustable-diameter bio-ring along the guide of the annular body. The bio-ring has a through hole in its circumferential direction for the passage of a first deformable conveying filament. The bio-ring (300) includes a bio-ring locking tip (301), a bio-ring locking ring (304), a first bio-ring (302), and a second bio-ring (303). The adjacent ends of the first bio-ring (302) and the second bio-ring (303) are connected as one unit. The front end of the bio-ring locking tip (301) has a pointed structure, and the outer periphery of the rear end has an external thread. The rear end of the bio-ring locking tip is connected to the first bio-ring (304). One end of 02) is fixedly connected, and one end of the biological ring locking ring (304) is fixedly connected to the end of the second biological ring. The inner wall of the biological ring locking ring (304) is provided with an internal thread, which is adapted to the external thread at the rear end of the biological ring locking tip. Under the guidance of the ring body, the biological ring locking tip (301) and the biological ring locking ring (304) are respectively pushed and locked by the first biological ring (302) and the second biological ring (303) to form a biological ring locking buckle, thereby forming a biological ring that surrounds the root of the original mitral valve leaflet.

[0041] Mitral valve prosthesis and delivery: The mitral valve prosthesis stent and the matching valve are fixed in the biological ring.

[0042] As a further improvement, in the aforementioned track-type mitral valve prosthesis implantation system, the connection between the mitral valve prosthesis stent and the valve is as follows: the mitral valve prosthesis stent (400) and the mitral valve prosthesis valve (404) are connected by a prosthesis valve suture support strip (410), the shape of which is consistent with the outer contour of the mitral valve prosthesis valve (404).

[0043] Fourthly, this application provides a method for operating a track-type mitral valve prosthesis implantation system, comprising the following steps:

[0044] Step 1): Ring formation: Using a mitral annular space ring formation device, a first deformable delivery wire is formed into an annular body surrounding the root of the original mitral valve leaflet. This annular body is a circular structure with an adjustable diameter. The mitral annular space ring formation device includes a capturing magnetic ball 101, a magnetic ball to be captured 104, a first deformable delivery wire 103, and a second deformable delivery wire 105. The top end of the first deformable delivery wire 103 is fixedly connected to the magnetic ball to be captured 104, and the capturing magnetic ball 101 is fixedly connected to the end of the second deformable delivery wire 105. The magnetic ball to be captured 104 is used to capture the capturing magnetic ball 101 to form a capture buckle connector. After forming the capture buckle connector, it is pulled out of the body from the catheter system along with the second deformable delivery wire 105, so that the first deformable delivery wire 103 forms an annular body surrounding the root of the original mitral valve leaflet.

[0045] Step 2): Cutting:

[0046] Including step 21): The two ends of the first deformable delivery wire 103 are fitted together with the mitral valve closure adjustment catheter (208). The mitral valve closure adjustment catheter (208) is gradually pushed into the body through the catheter system outside the body. The mitral valve closure adjustment catheter (208) is adjusted to compress and force the circumference of the annulus to become smaller, so that it contracts and adjusts the closure of the original mitral valve (210) in the human body, and fixes the original mitral valve in preparation for cutting.

[0047] Step 22): Using a laser cutter or a sharp micro-cutter (hereinafter referred to as "laser cutter or sharp micro-cutter" for ease of expression), the anterior leaflet is cut from a position away from the central axis of the mitral valve annulus to a position close to the central axis of the mitral valve annulus. After the cutting is completed, the mitral valve closure adjustment conduit (208) is withdrawn from the body, thereby restoring the shape of the annulus formed by the first deformable delivery wire (103), and the mitral valve slit is formed.

[0048] Step 3): Bio-ring insertion: Using the bio-ring insertion system, a bio-ring with an adjustable diameter is inserted along the guide of the ring body;

[0049] Step 4): Mitral valve prosthesis and delivery: The mitral valve prosthesis stent and the matching valve are delivered and released via transapical or transseptal delivery methods, so that the mitral valve prosthesis stent is fixed in the biological ring.

[0050] The operational method provided in this application involves four steps: ring creation, shearing, placement of a bio-ring, and delivery of the mitral valve prosthesis. First, ring creation lays the foundation for subsequent work. The shearing step effectively addresses the problem of the original mitral valve obstructing blood flow after prosthesis placement, causing left ventricular outflow tract obstruction. In the bio-ring placement step, the bio-ring, guided by the annular body, enters the annular space of the mitral valve, providing conditions for the subsequent fixation of the mitral valve prosthesis. During the delivery of the mitral valve prosthesis, the bio-ring can enter the recessed layer in the middle of the mitral valve prosthesis stent, making the fixation of the mitral valve prosthesis to the original diseased mitral valve more reliable. This effectively solves the problem of the mitral valve stent compressing the left ventricular outflow tract when deformed during release. Furthermore, the bio-ring effectively seals the annular space between the mitral valve prosthesis and the atrioventricular passage, allowing blood flow from the middle passage of the mitral valve prosthesis into the left ventricle. The size of the bio-ring can be adjusted to a more suitable diameter by the delivery catheter system. This allows for more reliable fixation and sealing of the mitral valve prosthesis. Therefore, the procedure described in this application enables the mitral valve to be firmly anchored, reliably sealed, and with a smooth passage during implantation.

[0051] As a further improvement, in the described operating method,

[0052] The transseptal delivery method in step 4) includes: the mitral valve prosthesis stent and valve, which are compressed into a contractile state, are delivered from the vena cava into the right atrium under the action of the delivery head and guidewire, and then the mitral valve prosthesis stent and valve are released through the atrial septum into the left atrium.

[0053] The transapical delivery method in step 4) includes: the mitral valve prosthesis stent and valve, which are compressed into a contractile state, are delivered through the apex of the heart under the action of the delivery head and guidewire, enter the left atrium through the left ventricle, and then the mitral valve prosthesis stent and valve are released.

[0054] The method for releasing the mitral valve prosthesis stent and valve after delivery via the apex includes:

[0055] First, the left fibrous triangular alignment element (406), the right fibrous triangular alignment element (405), and the anterior leaflet (409) of the top lotus layer (401) of the stent are exposed on the mitral valve prosthesis stent. Under the observation of fluoroscopic imaging technology, the alignment elements are adjusted and aligned. After the alignment is adjusted, the mitral valve prosthesis stent (400) is further exposed so that the radial constraint of the top lotus layer (401) of the stent is completely removed, allowing the top lotus layer (401) of the stent to expand on its own to form a flange that is close to the surface of the atrium. The middle recessed layer (402) of the stent is exposed, and the mitral valve prosthesis valve 404 expands outward more. The middle recessed layer of the stent expands to join with the mitral valve annulus. At this time, the unexpanded ear-shaped anchor gradually enters the mitral valve suture of the original lesion in the human body, preparing for the next step of capturing and supporting the tissue on both sides of the suture. At this time, the outside of the middle recessed layer (402) of the stent is exactly inside the biological ring (300).

[0056] The stent is pulled towards the atrium by the external catheter system, so that the bio-ring is located at the root of the mitral valve leaflet. At this time, the bio-ring locking tip is pushed into the bio-ring locking ring by the catheter system that controls the size of the bio-ring, so that the bio-ring is more tightly wrapped around the concave layer in the middle of the stent. Thus, the mitral valve is reliably fixed by the bio-ring and the concave layer in the middle of the stent.

[0057] Continue releasing the support layer at the bottom of the stent. At this time, the mitral valve prosthesis expands outward into a relaxed state. Meanwhile, the left auricular anchor (407) and the right auricular anchor (408) open the mitral valve suture of the original disease, thereby capturing the natural anterior leaflet and chordae tendineae between the left auricular anchor and the right auricular anchor and the mitral valve prosthesis stent, and the delivery work is completed.

[0058] The mitral valve annular space is a ring-shaped three-dimensional spatial structure. This space is annular and consists of the mitral valve annulus and the valve membrane. The biological ring can enter this annular space to form a complete biological ring.

[0059] This invention utilizes a bio-ring placement system to insert a bio-ring device that can lock and fix the mitral valve prosthesis stent. The bio-ring can enter the recessed layer in the middle of the mitral valve prosthesis stent, making the fixation of the mitral valve prosthesis to the pre-existing diseased mitral valve more reliable. This effectively solves the problem of the mitral valve stent compressing the left ventricular outflow tract when it deforms during release. Furthermore, the bio-ring can effectively seal the annular space between the mitral valve prosthesis and the atrioventricular passage, allowing blood flow to enter the left ventricle from the middle passage of the mitral valve prosthesis. This invention also utilizes a cutter to shear the pre-existing diseased mitral valve, effectively solving the problem of the pre-existing mitral valve obstructing blood flow and causing left ventricular outflow tract obstruction after prosthesis placement. In addition, the mitral valve prosthesis stent in this invention can expand the sheared pre-existing diseased mitral valve. Cutting seam This invention opens and dilates the blood flow channel between the mitral valve and the aortic valve. It summarizes the basic structure, basic operating steps, and methods of biological ring placement, mitral valve shearing, and mitral valve prosthesis stents and valves. This track-type mitral valve prosthesis implantation system and its operating method save surgical time, enabling the surgery to be completed safely and efficiently.

[0060] To address the problems of unreliable fixation and poor sealing after mitral valve prosthesis implantation, and the risk of obstruction due to mitral valve stent release deformation compressing the left ventricular outflow tract, thus affecting implantation efficacy, embodiments of this invention provide a ring-forming system and a bio-ring placement system for fixing the mitral valve prosthesis stent. The ring-forming system prepares for the subsequent placement of the bio-ring and mitral valve shearing. This system may include a capture magnetic ball, a target magnetic ball, two deformable delivery wires, a deformable delivery wire sheath, and a control catheter system. The deformable delivery wires are made of shape-memory metal (such as nickel-titanium alloy), which deforms between low-temperature and high-temperature shapes depending on temperature, i.e., its shape changes when sensing blood temperature within the blood vessel. The capture magnetic ball is located at the top of the second deformable delivery wire, and the target magnetic ball is located at the top of the first deformable delivery wire. The deformable delivery wire sheath encloses the corresponding deformable delivery wire, providing support. Under the action of the external catheter system, the capture magnetic ball gradually extends out of the deformable delivery wire sheath, capturing and fixing the target magnetic ball, forming a capture loop. Under the stretching action of the external catheter system, the capture loop enters the deformable delivery wire sheath and is then pulled out of the body. This system can form a ring-shaped structure composed of the first deformable delivery wire around the mitral valve annular space.

[0061] To address the issue that after mitral valve prosthesis implantation, the original mitral valve leaflets are stretched open by the stent, and the larger anterior leaflet wraps around the stent, obstructing blood flow and causing left ventricular outflow tract obstruction, embodiments of this invention provide a mitral valve shearing system. This mitral valve shearing system may include a cutting head, connecting tubing, and adjusting catheter (if a laser, such as a holmium laser, is used as the cutting medium, the cutting depth can be up to 4 mm to prevent accidental cutting of other tissues). The catheter connected to the cutting head can be inserted, and the angle range adjusted. When the diseased mitral valve is closed and fixed, the correct position is found, and the cutting head is used to cut from a position away from the annular central axis of the original diseased mitral valve. arrive The anterior leaflet is cut near the central axis of the mitral valve annulus. The pre-existing diseased mitral valve, after being opened by the auricular anchor in the mitral valve prosthesis stent, expands... Cutting seam Its function is to prevent the pre-existing mitral valve and chordae tendineae from wrapping around the periphery of the mitral valve prosthesis stent, making the blood flow channel created by the mitral valve prosthesis smoother, thereby inhibiting the obstruction of the left ventricular outflow tract and reducing mortality.

[0062] In addition, embodiments of the present invention provide a bio-ring placement system, which may include a bio-ring made of a biocompatible material with a diameter ranging from 4 to 6 cm. This bio-ring is formed by simultaneously pressing both ends of a delivery catheter system. Each end may have internal and external threads, respectively. During pressing, the external thread enters the internal thread, thereby locking the ring in place. After ring formation, the delivery catheter system may remain in the body temporarily. Once the mitral valve prosthesis stent is placed in the corresponding position, the size of the bio-ring can be adjusted by the delivery catheter system to a more suitable diameter, thereby more reliably fixing and sealing the mitral valve prosthesis.

[0063] This invention also provides a mitral valve prosthesis stent and valve, as well as an insertion method. The upper part of the stent can be shaped like a lotus flower, allowing it to fit tightly against the upper wall of the mitral valve in the left atrium when the stent is deployed, preventing blood flow impact. To prevent the lotus layer from compressing the aorta when the stent is deployed, an anterior leaflet of the lotus layer is provided, coinciding with the position of the anterior leaflet of the original mitral valve. The stent can have a central recessed layer with a diameter ranging from 4 to 6 mm, matching the diameter of the bio-ring in the aforementioned ring placement system. When the stent is deployed, the bio-ring enters this central recessed layer and locks in place. Due to the locking and fixing effect of the bio-ring on the mitral valve prosthesis, the mitral valve prosthesis will not dislodge with heartbeats or blood flow, or compress the left ventricular outflow tract, causing obstruction. In addition, the lower end of the stent can be slightly wider than the waist groove, allowing the pre-existing diseased mitral valve to open when the stent is deployed, creating a patent blood flow channel from the site of the pre-existing diseased mitral valve to the aortic valve site. In addition, to ensure alignment between the mitral valve stent and the existing diseased mitral valve anatomical structure during insertion, a radiopaque alignment element is installed. To ensure that the mitral valve stent, during release, opens and secures the suture cut by the aforementioned shearing system into the existing diseased mitral valve, two ear-shaped anchors are installed on the left and right sides. These ear-shaped anchors extend radially outwards, pointing towards the upstream left atrial end of the existing diseased mitral valve when viewed from above. These ear-shaped anchors are equipped with multiple spikes to further stabilize the fixation of the existing diseased mitral valve.

[0064] The mitral valve prosthesis can be implanted via transapical delivery or transseptal delivery. In the transseptal delivery method, the lower portion of the prosthesis (the support layer of the mitral valve prosthesis) is first released into the left ventricle. Then, it is slightly adjusted upwards to position the concave middle layer of the mitral valve prosthesis as close as possible to the root of the original diseased mitral valve. Finally, the left atrial portion (the lotus-shaped top layer of the mitral valve prosthesis) is released. Attached Figure Description

[0065] In the accompanying drawings, the same reference numerals represent the same location in different views, highlighting the principles of the invention. Details in the drawings have been simplified, such as the simplified omission of the chordae tendineae of the mitral valve.

[0066] Figure 1 The diagram illustrates the working state of the magnetic ball to be captured and the connection between the capturing magnetic ball and the conveyor wire in the ring-forming system.

[0067] Figure 2 The ring-forming process of the ring-forming system is shown (where, Figure 2 a shows the correct working position of the IUD system on the pre-existing mitral valve in the human body. Figure 2b shows that when the circulatory system is correctly positioned at the mitral valve, the magnetic sphere to be captured and the magnetic sphere to be captured attract each other to form a capture loop. Figure 2 c shows that after the annulus system forms a capture clasp in the mitral valve, the second deformable delivery wire pulls the capture clasp out of the mitral valve annular space. Figure 2 d shows that after the circumferential formation system completes the circumferential formation, the deformable delivery wire outer sheath exits the mitral valve annular space. Figure 2 e shows that after the circulatory system completes the circulatory system, the catheter system of the circulatory system is removed from the human body, and the mitral valve annular space forms a ring formed by the first deformable delivery wire, in preparation for the next working step.

[0068] Figure 3 A schematic diagram showing the operation of the cutter is provided. Figure 3 a shows a schematic diagram of the cutter structure. Figure 3 b shows the initial state of the cutter during operation in the embodiment. Figure 3 c shows the final state of the cutter during operation in the embodiment. Figure 3 d shows the mitral valve after it has been cut with a scalpel, resulting in a suture in the original mitral valve.

[0069] Figure 4 A schematic diagram of the biological cycle is shown. Figure 4 a shows a schematic diagram of the structure of the biological ring that needs to be inserted into the annular space of the human mitral valve. Figure 4 b shows a schematic diagram of the biological ring forming a locking buckle in its working state. Figure 4 c shows a schematic diagram of the 30° thread teeth on the outside of the biological ring locking tip and inside the locking ring. Figure 4 Figure d shows the state of the biological ring when it enters the annular space of the human mitral valve in the embodiment. Figure 4 e shows a schematic diagram of the working state of the biological ring when it enters the annular space of the human mitral valve in the embodiment;

[0070] Figure 5 This diagram shows the relevant schematic diagrams of the mitral valve prosthesis stent and valve. Figure 5 Figure a shows a schematic diagram of the mitral valve prosthesis stent and valve structure. Figure 5 b shows a schematic diagram of the mitral valve prosthesis stent and valve as viewed from an angled top, aiming to identify the shape and position of the anterior leaflet of the lotus layer at the top of the mitral valve prosthesis stent and the non-transparent alignment element. Figure 5 c shows a schematic diagram of the mitral valve prosthesis stent as viewed from a sloping top, designed to identify the position and structure of the ear-shaped anchor of the mitral valve prosthesis stent. Figure 5 Figure d shows the position of the mitral valve prosthesis stent alignment element and the auricle anchor in the human mitral valve, and a schematic diagram of the auricle anchor opening the original mitral valve suture after release. Figure 5e shows the position of the mitral valve prosthesis stent and valve in the human mitral valve when deployed and opened, thus forming a patent blood flow channel;

[0071] Figure 6 This illustrates the method of mitral valve prosthesis delivery. Figure 6 a illustrates a transapical mitral valve prosthesis delivery method. Figure 6 b illustrates the method of transseptal mitral valve prosthesis delivery;

[0072] Figure 7 This demonstrates that after the original mitral valve disease is cut, a bio-ring is inserted, and a mitral valve prosthesis and valve are inserted, a stable and unobstructed blood flow channel is formed between the left atrium and left ventricle, and between the left ventricle and aorta, maintaining the normal shape and function of the heart.

[0073] This invention has various modifications and alternatives, and specific embodiments are described in detail in the accompanying drawings by way of example. However, this invention is not intended to be limited to the specific embodiments, but rather to include all modifications and variations within the scope of this invention. Detailed Implementation

[0074] The track-type mitral valve prosthesis implantation system and operating method provided in this application are used to solve problems such as firm anchoring, reliable sealing, and unobstructed outflow tract during mitral valve prosthesis implantation. Based on the implementation steps and system functions, the embodiments disclosed herein involve four subsystems: a mitral valve annular space annulus device (…). Figures 1-2 ), mitral valve shearing system ( Figure 3 ), biological ring placement system ( Figure 4 ), mitral valve prosthesis ( Figure 5 ) and mitral valve prosthesis delivery and placement methods ( Figure 6 ).

[0075] First, this application discloses a track-type mitral valve implantation system, which includes:

[0076] Mitral valve annular spacer: such as Figure 1As shown, the mitral valve annular space ring-forming device includes a capturing magnetic ball 101, a magnetic ball to be captured 104, a first deformable delivery wire 103, and a second deformable delivery wire 105. Both the capturing magnetic ball 101 and the magnetic ball to be captured 104 are magnetic, and the magnetic forces are opposite poles attracting each other. The capturing magnetic ball 101 is fixedly connected to the end of the second deformable delivery wire 105. The magnetic ball to be captured 104 is located at the top of the first deformable delivery wire 103. The magnetic ball to be captured 104 relies on magnetic force to capture the capturing magnetic ball 101, and then they attract and fix to form a capture buckle connector 101 (104) (hereinafter referred to as "capture buckle"), thereby forming an annular structure. After the capture buckle connector 101 (104) is formed, the second deformable delivery wire 105 pulls the capture buckle connector into the deformable delivery wire outer sheath 106, and then it is pulled out of the body by the catheter system. The first deformable delivery wire 103 is formed into a ring-shaped, guideable channel that surrounds the root of the original mitral valve leaflets, and the diameter of the ring is adjustable. In actual operation, the ring is delivered to the corresponding working position, i.e., the root of the original mitral valve leaflets, by the first deformable delivery wire 103 and the catheter system.

[0077] The mitral valve shearing system mainly consists of a laser cutter 200 and a mitral valve closure adjustment conduit 208. The laser cutter 200 includes a laser transmission fiber 201, a conversion connector 202, an angle adjustment sub-section 203, a connector 204, a blade 205, a holmium laser 206 (approximately 4mm), and an angle adjustment line 207. The laser transmission fiber 201 is connected to the angle adjustment sub-section 203 via the conversion connector 202. The angle adjustment sub-section 203 is then connected to the blade 205 via the connector 204. All connections are threaded and can be sealed. The two ends of the angle adjustment line 207 are fixedly connected to the outer walls of the conversion connector 202 and the connector 204 respectively to facilitate blade angle adjustment.

[0078] In some embodiments, the laser cutter can be replaced with a sharp miniature cutter. The laser transmission fiber 201 in the laser cutter is replaced with a connecting tube, and a blade is set below the cutter head to form the miniature cutter.

[0079] The laser cutter or sharp micro-blade 200 can use two cutting media. If laser cutting is used, such as a holmium laser with a wavelength of 2.1 μm, which coincides with the absorption peak of water, the holmium laser's penetration depth in tissue is less than 0.4 mm due to the shielding effect of water. This allows for precise and safe cutting of the tissue surface without accidental cutting or perforation. The laser transmission fiber 201 uses quartz crystal for transmission and has a robust and wear-resistant coating to protect it from damage and breakage during use. If the blade is used to cut the mitral valve, it must be sharp enough to quickly cut the mitral valve.

[0080] In practice, a laser cutter or scalpel is used to cut the anterior leaflet from a position far from the central axis of the mitral annulus to a position close to the central axis of the mitral annulus, thus obtaining a mitral valve slit.

[0081] Bio-ring insertion system: includes bio-ring 300, such as Figure 4 As shown, the bio-ring 300 includes a bio-ring locking tip 301, a bio-ring locking ring 304, a first bio-ring 302 (on one side of the bio-ring locking tip), and a second bio-ring 303 (on one side of the bio-ring locking ring), wherein... Figure 4 As shown in Figure a, the adjacent ends of the first bio-ring 302 and the second bio-ring 303 are connected as one unit (the ends of the first bio-ring 302 and the second bio-ring 303 that are far from the bio-ring locking tip 301 and the bio-ring locking ring 304 are connected as one unit). The first and second bio-rings are originally a single strip shape, but for ease of description and demonstration, they are referred to as the first bio-ring and the second bio-ring, respectively. The bio-ring 300 has a through hole in its circumferential interior (i.e., inside the bio-ring in the length direction) for the passage of the first deformable conveying wire 103. The front end of the bio-ring locking tip 301 is a pointed structure, and the outer circumference of the rear end has an external thread. The rear end of the bio-ring locking tip 301 is fixedly connected to one end of the first bio-ring 302. One end of the bio-ring locking ring 304 is fixedly connected to the end of the second bio-ring 303. The inner wall of the bio-ring locking ring 304 has an internal thread, which is adapted to the external thread of the rear end of the bio-ring locking tip. Both the internal thread and the external thread are pagoda-shaped threads. The bioring locking tip 301 and bioring locking ring 304 are used to lock together under the push of the first bioring 302 and the second bioring 303 to form a bioring locking buckle. The bioring has a through hole for the passage of the first deformable conveying wire 103, and an inlet hole for the two ends of the first deformable conveying wire to be introduced. This inlet hole is located approximately in the middle of the bioring and communicates with the through hole. Guided by the annular body formed by the first deformable conveying wire 103, the bioring locking tip 301 and the bioring locking ring 304 are respectively pushed and locked by the first bioring 302 and the second bioring 303 to form a bioring locking buckle, thereby forming a bioring with an adjustable diameter for wrapping around the root of the original mitral valve leaflet.

[0082] like Figure 4As shown in Figure c, the external thread of the rear end of the bio-ring locking tip 301 forms a 30° angle with its central axis. Correspondingly, the internal thread of the bio-ring locking ring 304 also forms a 30° angle with its central axis. Guided by the 30° tip, the bio-ring locking tip 301 enters the bio-ring locking ring 304. Because the outer wall of the bio-ring locking tip 301 (i.e., its rear end) has threads forming a 30° angle with the central axis, and the inner wall of the bio-ring locking ring 304 also has threads forming a 30° angle with the central axis, the threads of the bio-ring locking tip 301 and the bio-ring locking ring 304 engage with each other. This allows the bio-ring locking tip 301 to slide forward along a 30° stepped surface when it advances; however, when it retracts, the back of the threads forms a 90° angle with the central axis, creating a blocking effect and preventing it from being pushed back (similar to a cable tie).

[0083] Mitral valve prosthesis and valve: The mitral valve prosthesis and valve and a matching valve are fixed in the bio-ring.

[0084] The mitral valve prosthesis stent 400 is anchored together with the mitral valve prosthesis 404 to achieve the function of a mitral valve prosthesis. The mitral valve prosthesis stent 400 can be made of shape memory alloy (such as nickel-titanium alloy) through laser cutting, photochemical etching, or other methods, and can restore its corresponding shape when released after reaching the corresponding position.

[0085] like Figure 5 As shown in Figure a, the mitral valve prosthesis stent is a radially self-expanding tubular body. The mitral valve prosthesis stent 400 includes a lotus-shaped top layer 401, a recessed middle layer 402, a bottom support layer 403, a left fiber triangle alignment element 406, a right fiber triangle alignment element 405, a left auricular anchor 407, a right auricular anchor 408, and an anterior leaflet 409 of the top lotus-shaped layer. The main body of the mitral valve prosthesis stent is composed of the interconnected top lotus-shaped layer 401, the recessed middle layer 402, and the bottom support layer 403.

[0086] like Figure 5As shown in Figure a, the outer surfaces of the top lotus layer 401, the middle recessed layer 402, and the bottom support layer 403 of the stent are connected to form a tubular body. The top lotus layer 401 is formed by multiple lotus petal-like filaments connected to form an annular flange. The anterior leaflet 409 of the top lotus layer 401 is provided at the front end of the top lotus layer 401. The anterior leaflet 409 is formed by three of the above-mentioned lotus-like filaments. The difference between the lotus-like filaments of the anterior leaflet 409 and other filaments (such as the filaments that make up the top lotus layer 401) is that the angle between the filaments of the anterior leaflet 409 and other filaments and the central axis of the mitral valve prosthesis stent 400 is different (e.g., the angle between the filaments of the anterior leaflet 409 and the prosthesis stent is 10°, while the angle between other filaments and the prosthesis is 45°). For the reasons mentioned above, the flange composed of lotus-like filaments is not a regular circle, but rather resembles the letter D, which allows for better anastomosis with the original mitral valve 210 anatomical structure in the human body.

[0087] On the left and right sides of the anterior leaflet 409 of the top lotus layer 401 of the stent, there are left fiber triangle alignment elements 406 and right fiber triangle alignment elements 405, respectively. These alignment elements have radiopaque areas to facilitate observation under fluoroscopic imaging during surgery. This allows for the calibration of the mitral valve prosthesis stent 400, ensuring that the left fiber triangle alignment element 406 is close to the left fiber triangle and the right fiber triangle alignment element 405 is close to the right fiber triangle, thus achieving precise release. The correct position of the stent's top lotus layer 401 in the heart is: the portion of the natural mitral valve location near the inner wall of the left atrium.

[0088] The middle recessed layer 402 of the stent is formed by triangular filaments connected together. Its characteristic feature is that the diameter of the formed flange is smaller than the diameter of the lotus-shaped layer 401 at the top of the stent, in order to form a recessed annular groove for the bio-ring to enter and be fixed within this groove. The correct position of the middle recessed layer 402 in the heart is: the location of the bio-ring within the natural mitral valve annulus.

[0089] The stent base support layer 403 is composed of triangular filaments, characterized in that the diameter of the formed flange is larger than the diameter of the recessed layer 402 in the middle of the stent. A left auricular anchor 407 and a right auricular anchor 408 are disposed on the stent base support layer 403, corresponding to the position of the anterior leaflet 409 of the top lotus layer. The auricular anchors (i.e., the left auricular anchor 407 and the right auricular anchor 408) are auricles extending radially outward from the mitral valve prosthesis stent, and their orientation is set upward towards the atrium. The correct position of the stent base support layer 403 in the heart is: the portion near the left ventricular wall of the natural mitral valve location.

[0090] The lotus-shaped layer 401 at the top of the support, the recessed layer 402 in the middle of the support, and the support layer 403 at the bottom of the support are connected and supported by columnar filaments.

[0091] like Figure 5 As shown in b (view of the mitral valve prosthesis stent 400 from an oblique top), the angles of the three lotus-like filaments in the anterior leaflet portion 409 of the top lotus layer of the mitral valve prosthesis stent 400 differ from the angles of the other lotus-like filaments, forming a D-shape. The left fiber triangle alignment element 406 and the right fiber triangle alignment element 405 are located on the lotus-like filaments on the left and right sides of the anterior leaflet portion 409 of the top lotus layer, respectively, and their shapes can be annular. The mitral valve prosthesis 404 is composed of three leaflets and can be extracted from animals such as pigs. The figure shows the valve state (closed state) observed from the atrium to the ventricle. The three leaflets of the mitral valve prosthesis 404 have closed and open states (not shown) as shown in the figure. In the open state, the three leaflets are pushed and contracted by blood flow, forming a blood flow channel to allow blood to flow smoothly from the atria into the ventricles. In the closed state, due to the reverse blood flow, the lower ends of the three leaflets are filled and compressed, closing the blood flow channel in the middle of the tricuspid valve prosthesis and preventing retrograde blood from flowing through that area. Once implanted, the prosthesis valve can replace the original diseased mitral valve 210, thereby reducing or eliminating valvular insufficiency. As mentioned above, the mitral valve prosthesis 404 has no valve covering at the site of the original diseased mitral valve suture 209 to allow blood to flow freely.

[0092] like Figure 5 As shown in Figure c, the mitral valve prosthesis stent 400 is viewed from the top. The mitral valve prosthesis stent 400 has a left auricular anchor 407 and a right auricular anchor 408. The angle of the auricular anchor extends radially outward. Viewed from the top of the stent, the auricular anchor points towards the left atrium upstream of the original mitral valve 210. The left / right auricular anchors have multiple spikes (as shown in the figure, the number of spikes on the auricular anchor is 8). The purpose of this design is that when the mitral valve prosthesis stent 400 is opened, the left auricular anchor 407 and the right auricular anchor 408 respectively support and open the slit on the original mitral valve 210, ensuring that the original mitral valve 210 and related chordae tendineae are more closely and firmly distributed on the auricular anchors. This prevents the blood flow channel created by this application through the slit 209 of the original mitral valve from closing due to blood flow impact or other reasons.

[0093] like Figure 5As shown in Figure c, the mitral valve prosthesis stent 400 and the mitral valve prosthesis valve 404 are connected by a prosthesis valve suture support strip 410. The shape of the prosthesis valve suture support strip 410 is consistent with the outer contour of the mitral valve prosthesis valve 404 (only a small portion of the prosthesis valve suture support strip 410 at the bottom support layer 403 of the stent is shown in the figure). Multiple suture points are distributed on the prosthesis valve suture support strip 410, which allow for the attachment of a valve prosthesis (such as pericardium) to this location. In this embodiment, the prosthesis valve is a tricuspid valve, therefore it includes three prosthesis valve suture support strips 410.

[0094] like Figure 5 As shown in diagram d, the mitral valve prosthesis stent 400 is correctly positioned. The left fibrous trigone alignment element 406 and the right fibrous trigone alignment element 405 of the mitral valve prosthesis stent 400 are placed at the left and right ends of the original mitral valve incision 209, respectively, to ensure that the original mitral valve incision is centered as much as possible, and that the left fibrous trigone alignment element 406 is close to the left fibrous trigone, and the right fibrous trigone alignment element 405 is close to the right fibrous trigone. After the mitral valve prosthesis stent 400 is released and opened, the left auricle anchor 407 (right auricle anchor 408) gradually extends into the original mitral valve incision 209. Over time, the left auricle anchor 407 and the right auricle anchor 408 gradually extend and stretch, slowly opening up the original mitral valve incision 209.

[0095] like Figure 5 As shown in Figure e, after the mitral valve prosthesis stent 400 and mitral valve prosthesis valve 404 are implanted, their positions in the heart are as follows: the alignment components of the mitral valve prosthesis stent 400, namely the left fibrous trigone alignment element 406 and the right fibrous trigone alignment element 405, are located in the left and right fibrous trigone areas of the original diseased mitral valve 210, respectively. The anterior leaflet 409 of the top lotus layer is located within the range between the left and right fibrous trigone areas. Due to the gentle angle, it does not compress the tissue near the aorta, thus maintaining the patency of the blood flow channel and maintaining the normal structural morphology and pumping function of various parts of the heart (aortic valve 501, left ventricle 503, right ventricle 506, aorta 507, etc.).

[0096] Secondly, based on the aforementioned system, this application provides an operating method for the system, specifically including the following steps: including:

[0097] First step: Ring creation: This ring creation is performed by a mitral valve annular space ring creation device.

[0098] like Figure 2As shown in Figure 2, the positioning support tip 107 is delivered to a designated position in the ventricle by an external catheter delivery system. This positioning support tip 107, along with the deformable delivery wire sheath 106, the first deformable delivery wire 103, and the second deformable delivery wire 105, all enter the left ventricle of the heart through the catheter 108 of the external catheter delivery system. (The external catheter delivery system is a system capable of performing a series of operations outside the human body, such as insertion, delivery, and positioning. In this invention, all actions achievable within the heart are completed through the external catheter delivery system.) This provides positioning support for the subsequent annulus creation procedure. The deformable delivery wire sheath 106 is delivered by the catheter delivery system into the mitral valve annular space within the ventricle, where the capturing magnetic ball 101, the magnetic ball to be captured 104, the second deformable delivery wire 105, and the first deformable delivery wire 103 are ejected.

[0099] As it continues to advance within the annular space of the mitral valve in the human body, components made of shape memory alloy, such as the second deformable delivery wire 105 and the first deformable delivery wire 103, sense the temperature changes brought by the blood and gradually transform into an extended state. The magnetic ball to be captured 104 and the capturing magnetic ball 101 attract each other to form a capture buckle connector 101 (104).

[0100] The capture buckle 101 (104) is pulled into the deformable conveyor sheath 106 by the first deformable conveyor wire 103 and the second deformable conveyor wire 105. The deformable conveyor sheath 106 and the positioning support tip 107 are then pulled out of the body by the external delivery conduit system. Thus, a [structure / structure] is formed. Figure 2 As shown in Figure e, the annular body (ring-shaped body) formed by the first deformable delivery wire 103 surrounds the root of the original mitral valve leaflet. Due to the deformable nature of the first deformable delivery wire 103, the size of the annular circumference of this annular body (i.e., the ring-shaped body) is passively adjusted. (The most important function of the positioning support tip 107 in the ring-forming process is to provide support, because all the tubing is soft and requires a supporting force during this process. After the formation of the capture buckle 101 (104), it can be withdrawn, but withdrawing it midway will affect other tubing in the catheter delivery system. Therefore, all tubing is withdrawn together after the final annular body surrounding the root of the original mitral valve leaflet is formed.)

[0101] Step Two: Shearing: Completed by the mitral valve shearing system (transcatheter mitral valve shearing system), such as Figure 3 As shown in a,

[0102] The mitral valve closure adjustment catheter 208 is controlled by a catheter delivery system. After the mitral valve annular space annular device completes the annular creation step, the two ends of the first deformable delivery wire 103 can be obtained outside the body, while the remaining part (annular body) of the first deformable delivery wire 103 remains at the root of the original diseased mitral valve annulus. At this time, outside the human body, the two ends of the first deformable delivery wire 103 are pinched together to form a strand. This strand of metal wire, composed of two first deformable delivery wires 103, is threaded into the mitral valve closure adjustment catheter 208. Then, outside the human body, the mitral valve closure adjustment catheter 208 is gradually pushed into the vicinity of the original diseased mitral valve through the catheter delivery system. During the process of gradually pushing the mitral valve closure adjustment catheter 208, the mitral valve closure adjustment catheter 208 can deform the annulus formed by the above-mentioned annulus creation step, which is formed by the first deformable delivery wire 103 around the root of the valve annulus (i.e., the root of the mitral valve leaflet). This causes the circumference of the annulus to decrease, thereby causing the annulus to contract and compress the closure of the original diseased mitral valve 210, preparing for the shearing of the diseased mitral valve.

[0103] As described above, the closed mitral valves are evenly distributed across the cross-section of the atrioventricular passage, facilitating cutting and positioning by a laser cutter or a sharp micro-blade 200. The angle adjustment section 203 in the laser cutter or sharp micro-blade 200 is made of a deformable material, and the angle is adjusted by an angle adjustment line 207 so that the blade 205 is aligned with different positions of the mitral valve for cutting.

[0104] like Figure 3 bc indicates that when the laser cutter or sharp miniature cutter 200 is working, the initial state is that the cutter head 205 is aligned with the large diameter of the original mitral valve disease in the human body to begin cutting. Under the action of the angle adjustment line 207, the laser cutter or sharp miniature cutter 200 gradually moves the cutter head 205 towards the center of the atrioventricular passage (the cutter head moves from the position of the original mitral valve disease away from the central axis of the valve annulus). arrive The anterior leaflet is cut near the central axis of the mitral valve annulus. Following the movement of the cutter head 205, the mitral valve slit 209 is formed. After the cutting is completed, the mitral valve closure regulating catheter 208 is withdrawn from the body. At this point, the annulus formed by the first deformable delivery wire 103 returns to its original shape, and the mitral valve slit 209 is formed.

[0105] Step 3: Placement of the biological ring: This is completed by the biological ring placement system, such as... Figure 4Specifically, the first bio-ring 302 and the second bio-ring 303 are disposed within the conduit of the external conduit system. The bio-ring locking tip 301 and the bio-ring locking ring 304 are gradually brought together by the pushing action of the external conduit system. After they come together, the first bio-ring 302 (on the side of the bio-ring locking tip) and the second bio-ring 303 (on the side of the bio-ring locking ring) are further compressed, causing the bio-ring locking tip 301 to enter and lock inside the bio-ring locking ring 304, forming a bio-ring locking buckle 301 (304). Figure 4 As shown in b.

[0106] like Figure 4 As shown in the diagram, under the guidance of the first deformable delivery wire 103, the bio-ring locking tip 301 and the bio-ring locking ring 304 enter the annular space of the mitral valve 100 and meet under the action of external pushing force. Under the continued action of external pressure, the bio-ring locking tip 301 enters the internal locking teeth of the bio-ring locking ring 304, and the two lock together to form a bio-ring locking buckle 301 (304). At this point, the bio-ring 300 is placed into the annular space of the mitral valve 100 (as shown in the diagram). Figure 4 e) The biological ring surrounds the root of the original mitral valve leaflet;

[0107] Step 4: Mitral valve prosthesis delivery and placement:

[0108] There are two delivery and release methods for the mitral valve prosthetic stent 400 and the mitral valve prosthetic valve 404: transapical delivery and transseptal delivery.

[0109] like Figure 6 A method for transapical delivery of a mitral valve prosthesis stent 400 and a mitral valve prosthesis 404 is illustrated. The delivery device and system 604 carries the mitral valve prosthesis stent and valve 603 compressed into a contractile state. Under the action of the delivery head 601 and guidewire 602, it enters the heart via the apex 508, overcoming interference from the chordae tendineae 504 and papillary muscles 505, and enters the left atrium 502 through the left ventricle 503. Manipulating the delivery system first exposes the left fibrous trigone alignment element 406, the right fibrous trigone alignment element 405, and the anterior leaflet 409 of the top lotus layer 401 of the stent's top lotus layer on the mitral valve prosthesis stent 400. Under fluoroscopic observation, the physician can observe the light-blocking alignment elements, namely the left fibrous trigone alignment element 406 and the right fibrous trigone alignment element 405. By rotating the delivery device and system 604, the alignment elements are adjusted and aligned.

[0110] After alignment adjustment, the delivery device and system 604 continues to contract, further exposing the mitral valve prosthesis stent 400. This completely removes the radial constraint of the lotus-shaped layer 401 at the top of the stent, allowing it to expand further to form a flange that adheres tightly to the atrial surface. The central recessed layer 402 of the stent continues to be exposed, allowing the mitral valve prosthesis 404 to expand further outward. The central recessed layer 402 expands to engage with the mitral valve annulus, and at this point, the undilated auricular anchors gradually enter the mitral valve suture 209 of the original lesion, preparing for the next step of capturing and supporting the tissue on both sides of the suture. If misalignment occurs, the delivery system can be slightly adjusted to allow the undilated left auricular anchor 407 and right auricular anchor 408 to enter the mitral valve suture 209 of the original lesion. At this point, the outer part of the central recessed layer 402 is precisely inside the bio-ring 300.

[0111] After the mitral valve is fixed by the bio-ring 300 and the recessed layer 402 in the middle of the stent, the stent is pulled towards the atrium by the external catheter system, so that the bio-ring 300 is positioned as close as possible to the root of the mitral valve leaflets. At this time, the catheter system, which controls the size of the bio-ring 300, continues to push the bio-ring locking tip 301 into the locking teeth 304 inside the bio-ring locking ring, making the bio-ring 300 more securely surround the recessed layer 402 in the middle of the stent. Thus, the mitral valve is reliably fixed by the bio-ring 300 and the recessed layer 402 in the middle of the stent, preventing the stent from slipping due to blood flow or other reasons.

[0112] The delivery device and system 604 are further contracted, and the base support layer 403 of the stent continues to be released. At this time, the mitral valve prosthesis 404 expands outward into a relaxed state. Simultaneously, the left auricle anchor 407 and the right auricle anchor 408 open the original mitral valve suture 209, thereby capturing the natural anterior leaflet and chordae tendineae 504 between the left auricle anchor 407 and the right auricle anchor 408 and the mitral valve prosthesis stent 400. After the delivery is completed, the delivery device and system 604 is withdrawn, and the prosthesis is removed from the heart through the apical incision, followed by ligation and suturing of the apical incision.

[0113] like Figure 6 b illustrates a method for transseptal delivery of a mitral valve prosthesis stent 400 and a mitral valve prosthesis valve 404. The delivery device and system 604 carries a mitral valve prosthesis stent 603 compressed into a contractile state. Under the action of the delivery head 601 and guidewire 602, it enters the right atrium 510 through the vena cava and continues to puncture the atrial septum 509 (usually through the fossa ovalis) to enter the left atrium 502. The release method and steps of the mitral valve prosthesis stent 400 and mitral valve prosthesis valve 404 are similar to those of the transapical delivery method and will not be described in detail.

[0114] like Figure 7As shown, after multiple steps including the mitral valve annular space ring-forming device, mitral valve shearing system, biological ring placement system, and mitral valve prosthesis delivery and placement system, a smooth blood flow channel is formed between the left atrium and left ventricle of the heart. The mitral valve prosthesis will not fall off due to heartbeat or blood flow, so as to achieve and maintain the normal structural morphology of various parts of the heart (such as the tissue near the aortic valve). As mentioned above, the expansion and deformation of the mitral valve stent will not compress the left ventricular outflow tract, and the original anterior leaflet of the mitral valve will not obstruct blood flow, avoiding obstruction of the left ventricular outflow tract, thus realizing the normal pumping function of the heart.

[0115] The specific embodiments described above are merely preferred embodiments of this invention and should not be construed as limiting the scope of the invention. Therefore, equivalent variations made according to the claims of this invention are still within the scope of this invention.

Claims

1. A track-type mitral valve prosthesis implantation system, characterized in that: include The mitral valve annular space ring-forming device includes a first deformable conveying wire and a second deformable conveying wire. One end of the first deformable conveying wire is fixed with a magnetic ball to be captured, and one end of the second deformable conveying wire is fixed with a capturing magnetic ball with a magnetic dissimilarity to the magnetic ball to be captured. The first deformable conveying wire or the second deformable conveying wire is used to form a ring-shaped guide channel under the mutual attraction of magnetic balls with dissimilarity. A biological ring, which is strip-shaped when freely extended, has two free ends configured to lock together when the main body of the biological ring is pushed along the guide channel to form a biological ring locking buckle; The mitral valve prosthesis stent is a radially self-expanding tubular body. The mitral valve prosthesis stent includes a connected top lotus layer, a middle recessed layer, and a bottom support layer. The bottom support layer is provided with left / right ear-shaped anchors. The middle recessed layer is fixed within a bio-ring. The operation method of the system includes the following steps: Step 1): Creating a guideable channel for the biological ring: Using an external catheter delivery system, the deformable delivery wire sheath and the mitral valve annular space ring-forming device are placed into the mitral valve annular space. Under the guidance of the deformable delivery wire sheath, the second deformable delivery wire and the first deformable delivery wire are advanced in the mitral valve annular space. The capturing magnetic ball and the magnetic ball to be captured attract each other to form a capture buckle joint. Thus, the first deformable delivery wire forms a guideable channel in the shape of a ring around the root of the mitral valve leaflet. Step 2): Insertion of the bio-ring to form a ring structure around the root of the mitral valve: Push the bio-ring along the channel described in Step 1) to lock the two ends of the bio-ring to form a bio-ring locking buckle. At this point, the bio-ring is inserted into the ring space at the root of the mitral valve, and the bio-ring surrounds the root of the mitral valve. Step 3): Mitral valve prosthesis delivery and placement: The compressed mitral valve prosthesis stent is delivered to the left atrium via the apex or septum, the mitral valve prosthesis stent is released, and its central recessed layer is fixed in the bio-ring; in, After the mitral annular space ... Under the guidance of the first deformable conveyor wire, the bio-ring locking tip and the bio-ring locking ring enter the annular space of the mitral valve and meet under the action of external pushing force. Under the continued action of external pressure, the bio-ring locking tip enters the internal locking teeth of the bio-ring locking ring, and the two lock together to form a bio-ring locking buckle; at this point, the bio-ring is placed into the annular space of the mitral valve.

2. The system according to claim 1, characterized in that: The first deformable conveyor wire and the second deformable conveyor wire are made of shape memory metal.

3. The system according to claim 1, characterized in that: The bio-ring has through holes along its length for the passage of the first / second deformable conveying wires; the two ends of the bio-ring are respectively set as a bio-ring locking tip and a bio-ring locking ring, the bio-ring locking tip has an external thread, and the bio-ring locking ring has an internal thread adapted to the external thread. The bio-ring locking tip is used to enter the bio-ring locking ring to form the bio-ring locking buckle.

4. The system according to claim 3, characterized in that: The front end of the bio-ring locking tip is configured as a tip structure, and the outer periphery of the rear end has the external thread; one side of the thread tooth of the external thread of the bio-ring locking tip is at 30° with its central axis, and one side of the thread tooth of the internal thread of the bio-ring locking ring is at 30° with its central axis.

5. The system according to claim 1, characterized in that: The left / right ear-shaped anchors are provided with multiple barbs in their respective circumferential directions; the left / right ear-shaped anchors are ear-shaped pieces that extend radially outward from the mitral valve prosthesis stent, and their direction is set to be inclined upward.

6. The system according to claim 5, characterized in that: A small leaflet is provided at the front end of the top lotus layer of the support. A left fiber triangular area alignment element and a right fiber triangular area alignment element are respectively provided on the top lotus layer of the support on the left and right sides of the small leaflet of the top lotus layer. The left / right ear-shaped anchor is provided on the bottom support layer of the support corresponding to the position of the small leaflet of the top lotus layer. The angle between the filamentous material forming the anterior leaflet of the top lotus layer and the central axis of the mitral valve prosthesis stent is 10°, and the angle between the filamentous material forming the top lotus layer of the stent and the central axis of the mitral valve prosthesis stent is 45°.

7. The system according to any one of claims 1-6, characterized in that: The system also includes a valve adapted to the mitral valve prosthesis stent, and the mitral valve prosthesis stent and the mitral valve prosthesis valve are connected by a prosthesis valve suture support strip, the shape of which is consistent with the outer contour of the mitral valve prosthesis valve.

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