A trans-catheter mitral valve prosthesis implantation system and method of operation

Abstract

The application discloses a channel type mitral valve prosthesis implantation system, which comprises a plurality of deformable biological ring guide wires, the end of each of the biological ring guide wires is provided with a bendable hook, the hooks are used for forming a guideable channel, and the channel is annular in shape; a biological ring which is in the shape of a strip when freely stretched, two free ends of the biological ring are configured to be locked when a main body part of the biological ring is pushed along the channel to form a biological ring locking buckle; and a mitral valve prosthesis support which is fixed in the biological ring. The system is simple to operate, saves operation time, and enables safe and efficient completion of the operation.

Description

TECHNICAL FIELD

[0001] The present application relates to a transcatheter mitral valve prosthesis stent and a valve implantation method, in particular to a channel type mitral valve prosthesis implantation system and an operation method. BACKGROUND

[0002] With the social development trend of aging in China, the incidence of senile valvular degenerative diseases is increasing, among which mitral valve disease can lead to gradual decline in left heart function. For patients with severe mitral valve disease, surgical mitral valve replacement was once the only treatment to prolong life, but elderly patients are often contraindicated for surgery due to advanced age, poor physical condition, severe disease or other diseases. For patients with high risk or contraindication for cardiac surgery, transcatheter mitral valve implantation can now be used as an effective treatment.

[0003] Mitral valve replacement is a heart surgery that replaces the original diseased or abnormal heart mitral valve with an artificial valve. Its main indications are mitral stenosis, severe calcification of the valve, or mitral regurgitation. The existing method mainly has the following main problems: the anchoring after the implantation of the mitral valve prosthesis is unreliable, the sealing is not strict; the mitral valve stent expands and deforms to squeeze the left ventricular outflow tract, and the original anterior valve blocks part of the blood flow, thereby causing left ventricular outflow tract obstruction.

[0004] Therefore, there is an urgent need for a system and method that can solve the problems of firm anchoring, reliable sealing, and smooth passage during mitral valve implantation. SUMMARY

[0005] To solve the technical problems in the prior art, the present application provides a channel type mitral valve prosthesis implantation system.

[0006] A channel type mitral valve prosthesis implantation system, comprising a plurality of deformable biological ring guide wires, each of the plurality of biological ring guide wires has a bendable hook at the end, and the hooks are used to form a guideable channel;

[0007] A biological ring, which is in the shape of a strip when freely stretched, and the two free ends of the biological ring are configured to be locked when the main body of the biological ring is pushed along the channel to form a biological ring locking buckle;

[0008] A mitral valve prosthesis stent is fixed in the biological ring.

[0009] As a further improvement, the plurality of biological ring guide wires are distributed around the central axis at 360°; the biological ring guide wire is made of a memory metal.

[0010] As a further improvement, the two free ends of the biological ring are respectively provided with a biological ring locking tip and a biological ring locking ring, the biological ring locking tip is provided with an external thread, and the biological ring locking ring is internally provided with an internal thread matched with the external thread, and the biological ring locking tip is used to enter the biological ring locking ring to form the biological ring locking buckle.

[0011] As a further improvement, the biological ring comprises a biological ring locking tip, a biological ring locking ring, a first biological ring and a second biological ring, the first biological ring and the second biological ring are connected, the front end of the biological ring locking tip is a tip structure, the outer periphery of the rear end of the biological ring locking tip is provided with the external thread, and the rear end of the biological ring locking tip is fixedly connected with the end of the first biological ring, the biological ring locking ring is fixedly connected with the end of the second biological ring, and the internal wall of the biological ring locking ring is provided with the internal thread; one side of the thread of the external thread of the biological ring locking tip is 30° to the central axis thereof, and one side of the thread of the internal thread of the biological ring locking ring is 30° to the central axis thereof.

[0012] As a further improvement, the mitral valve prosthesis stent is a radial self-expanding tubular body, comprising a stent top lotus layer, a stent middle recessed layer and a stent bottom support layer connected in communication; the stent bottom support layer is provided with left / right ear-shaped anchoring members, and each of the left / right ear-shaped anchoring members is provided with a cutting piece; the stent middle recessed layer is fixed in the biological ring.

[0013] As a further improvement, a top lotus layer front leaflet part is arranged at the front end of the stent top lotus layer, left / right fibrous triangular area alignment elements are respectively arranged on the stent top lotus layer on the left and right sides of the top lotus layer front leaflet part, the left / right ear-shaped anchoring members are arranged on the stent bottom support layer corresponding to the position of the top lotus layer front leaflet part, and the cutting pieces are respectively arranged on the left / right ear-shaped anchoring members;

[0014] The left / right ear-shaped anchoring members are respectively provided with a plurality of spines in the respective circumferences;

[0015] The angle between the filaments constituting the top lotus layer front leaflet part and the central axis of the mitral valve prosthesis stent is 10°, and the angle between the filaments constituting the stent top lotus layer and the central axis of the mitral valve prosthesis stent is 45°;

[0016] The left / right ear-shaped anchoring members are ear pieces extending radially outward from the mitral valve prosthesis stent, and their directions are arranged to be upwardly inclined.

[0017] As a further improvement, the system further comprises a valve matched with 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, and the shape of the prosthesis valve suture support strip is consistent with the external contour of the mitral valve prosthesis valve.

[0018] The mitral valve prosthesis is a radial self-expanding tubular body, comprising a top lotus layer, a middle concave layer and a bottom support layer which are connected in sequence; the bottom support layer is provided with a left ear-shaped anchor and a right ear-shaped anchor, and each of the left ear-shaped anchor and the right ear-shaped anchor is provided with a cutting piece.

[0019] As a further improvement, a top lotus layer front lobe part is arranged at the front end of the top lotus layer, a left / right fibrous trigone alignment element is arranged on the left and right sides of the top lotus layer of the top lotus layer front lobe part respectively, and the left ear-shaped anchor and the right ear-shaped anchor are arranged on the bottom support layer corresponding to the position of the top lotus layer front lobe part; the left ear-shaped anchor and the right ear-shaped anchor are respectively provided with a plurality of spines in the circumferential direction.

[0020] The application also provides an operation method of the system, comprising:

[0021] Step 1): to create a guided channel for the biological ring: a plurality of biological ring guide wires are introduced into the mitral annulus space by using an external catheter delivery system, the plurality of biological ring guide wires are gradually pushed out and stretched to be completely exposed, the plurality of biological ring guide wires are distributed around the central axis at 360° and are bent at the end to form a hook, the hook is tightly attached to the inner wall of the mitral annulus space, and the hooks form a guided channel through which the biological ring can pass in the mitral annulus space;

[0022] Step 2): to place the biological ring to form an annular structure surrounding the mitral valve root: the biological ring is pushed along the channel in step 1) to make the two ends of the biological ring locked to form a biological ring locking buckle, and then the biological ring is placed in the annular space of the mitral valve root, and the biological ring surrounds the mitral valve root;

[0023] Step 3): to deliver and place the mitral valve prosthesis: the compressed mitral valve prosthesis is delivered to the left atrium through the transapical or transseptal delivery, and the mitral valve prosthesis is released and fixed in the biological ring.

[0024] The application is further described as follows:

[0025] In a first aspect, the application provides a biological ring for fixing a mitral valve prosthesis, the biological ring (100) comprising a biological ring locking tip (101), a biological ring locking ring (102), a first biological ring (103) and a second biological ring (104), adjacent ends of the first biological ring (103) and the second biological ring (104) being integrated into one, and being an entirety when fully pushed out. The front end of the biological ring locking tip (101) is a tip structure, the outer periphery of the rear end has external threads, and the rear end of the biological ring locking tip is fixedly connected with one end of the first biological ring (103). The biological ring locking ring (102) is fixedly connected with the end of the second biological ring (104) at one end. An inner thread is formed on the inner wall of the biological ring locking ring (102), which is matched with the external threads of the rear end of the biological ring locking tip. The biological ring locking tip (101) and the biological ring locking ring (102) are pushed and locked by the first biological ring (103) and the second biological ring (104) under the guidance of a biological ring auxiliary forming system to form a biological ring locking buckle, and then a biological ring wrapping around the original mitral valve leaflet root is formed. The biological ring auxiliary forming system provided by the application can adjust the diameter of the biological ring formed by the system, and can more reliably fix and seal the mitral valve prosthesis.

[0026] As a further improvement, the external threads of the rear end of the biological ring locking tip (101) are pagoda-shaped threads, and the angle of one side of the thread tooth is 30° with respect to the central axis. The inner thread of the biological ring locking ring (102) is also a pagoda-shaped inner thread, and the angle of one side of the thread tooth of the inner thread is 30° with respect to the central axis. In the application, the external threads of the rear end of the biological ring locking tip are matched with the inner threads of the biological ring locking ring, and the tooth side is set to 30°, which can make the biological ring locking tip more easily enter the biological ring locking ring, and facilitate the operator to operate. The other side of the thread tooth of the inner thread is 90° with respect to the central axis, which is to prevent the external thread tooth of the biological ring locking tip (101) from exiting the inner thread tooth of the biological ring locking ring (102).

[0027] As a further improvement, the biological ring is formed into a ring body by a biological ring auxiliary forming system (200), and the biological ring auxiliary forming system (200) is composed of a plurality of deformable biological ring guide wires (201). One end of the biological ring guide wire (201) has a specially shaped hook (202), and the other end can be collected in an external catheter delivery system (203). The shape of the biological ring guide wire (201) is as shown in Figure 2a. According to different needs, the biological ring guide wire (201) can be adjusted to different numbers, and the biological ring guide wire (201) is uniformly distributed around the central axis at 360°. When fully inserted, the specially shaped hook (202) can be tightly attached to the inner wall of the mitral annular space, so that the mitral annular space forms a channel to ensure the smooth insertion and ring formation of the biological ring, as shown in Figure 2 b.

[0028] The biological ring assisted shaping system (200) is inserted through the apex (204) by an external catheter delivery system (203). After insertion, the biological ring guide wire (201) of the biological ring assisted shaping system (200) is gradually pushed out and stretched by external operation. After the biological ring guide wire (201) is fully pushed out, it forms a track in the mitral annular space that the biological ring can pass through. This track is made of radiopaque material and can be clearly visible under external imaging, making it easy for medical staff to operate and insert the biological ring. The structure of the biological ring assisted shaping system provided in this application is cleverly designed, with multiple specially shaped hooks forming a smooth track (channel). This track surrounds the root of the mitral valve leaflet, providing a guide for the insertion of the biological ring, making it easy for the operator to operate.

[0029] The mitral annular space is a ring-shaped three-dimensional space structure, as shown in Figure 2 b. As shown in 206, this space is ring-shaped and is composed of the mitral annulus and the valve. The biological ring can enter this ring-shaped space to form a complete biological ring.

[0030] In a second aspect, the present application provides a mitral valve prosthesis stent (300) that can achieve shearing. It is a radially self-expanding tubular body. The mitral valve prosthesis stent (300) is fixed by the biological ring described above after release. The mitral valve prosthesis stent (300) includes a stent top lotus layer (310), a stent middle concave layer (313), and a stent bottom support layer (314) connected in series.

[0031] The stent top lotus layer (310) is formed by connecting a plurality of lotus petal-like filaments to form a ring-shaped flange. A top lotus layer front leaflet part (308) formed by a plurality of lotus-like filaments is provided at the front end of the stent top lotus layer (310). Left and right fibrous trigone alignment elements (311) and (312) are respectively provided on the left and right sides of the stent top lotus layer (310) of the top lotus layer front leaflet part (308). As a further improvement, the angle between the filaments forming the top lotus layer front leaflet part (308) and the central axis of the mitral valve prosthesis stent (300) is 10°, and the angle between the filaments forming the stent top lotus layer (310) and the central axis of the mitral valve prosthesis stent (300) is 45°.

[0032] The middle concave layer (313) of the stent is connected by triangular filaments, the flange formed by the triangular filaments has a smaller diameter than the diameter of the top lotus layer (310) of the stent, so as to form a concave annular groove, the left ear-shaped anchor (302) and the right ear-shaped anchor (303) are arranged at positions corresponding to the front leaflet part (308) of the top lotus layer, the left ear-shaped anchor (302) and the right ear-shaped anchor (303) are provided with a cutting piece (306) for cutting the anterior leaflet of the bicuspid valve at a connecting position with the bottom support layer (314) of the stent, and the left ear-shaped anchor (302) and the right ear-shaped anchor (303) are key components for achieving bicuspid valve cutting and support. The left ear-shaped anchor (302) and the right ear-shaped anchor (303) can be provided with a cutting shape position and a support shape position according to different functions. In the cutting shape position, the left ear-shaped anchor (302) and the right ear-shaped anchor (303) can pass through the chordae tendineae of the bicuspid valve, cut the anterior leaflet part of the bicuspid valve in the middle of the chordae tendineae, and draw an upward fine cut, as shown in FIG. 3b. In the support shape position, the left ear-shaped anchor (302) and the right ear-shaped anchor (303) can automatically support the bicuspid valve cut on both sides as described above to facilitate the passage of blood flow, the left ear-shaped anchor (302) and the right ear-shaped anchor (303) are ear-shaped flaps extending radially outward from the stent, and their directions are arranged to be upwardly inclined toward the atrial part; a plurality of spines are arranged downward on the circumference of the left ear-shaped anchor and the right ear-shaped anchor, respectively, which helps the left ear-shaped anchor (302) and the right ear-shaped anchor (303) to capture the two sides of the bicuspid valve cut.

[0033] The bottom support layer (314) of the stent is connected by triangular filaments, the flange formed by the triangular filaments has a larger diameter than the diameter of the middle concave layer (313) of the stent;

[0034] Each layer between the top lotus layer (310) of the stent, the middle concave layer (313) of the stent, and the bottom support layer (314) of the stent is connected and supported by cylindrical filaments.

[0035] In a third aspect, the present application provides a channel type bicuspid valve prosthesis implantation system, comprising:

[0036] The biological ring assisted forming system assists in forming a track (channel): the biological ring assisted forming system (200) is placed into the left ventricle through the apex of the heart, the biological ring guide wire (201) is gradually pushed out and stretched, a channel through which the biological ring can smoothly pass is formed in the annular space of the bicuspid valve, and subsequent medical personnel can operate to place the biological ring;

[0037] Biological ring implantation: after the biological ring assisted forming system is implanted into the ventricle, under the guidance of the annular space track formed by the biological ring guide wire (201) of the biological ring, the biological ring moves along the annular space track, the biological ring locking tip (101) and the biological ring locking ring (102) of the biological ring (100) are respectively pushed and locked by the first biological ring (103) and the second biological ring (104) under the guidance of the track to form a biological ring locking buckle, and then a biological ring surrounding the original mitral valve leaflet root is formed;

[0038] Shearing: cutting the mitral valve by using the sharp cutting piece (306) on the left ear-shaped anchor (302) and the right ear-shaped anchor (303) of the mitral valve prosthesis stent (300);

[0039] Implantation of the mitral valve prosthesis: implanting the mitral valve prosthesis stent and the matching valve into the biological ring.

[0040] As a further improvement, in the system, the connection mode between the mitral valve prosthesis stent and the valve is that the mitral valve prosthesis stent (300) is connected with the mitral valve prosthesis valve (309) by a prosthesis valve suture support bar (315), and the shape of the prosthesis valve suture support bar (315) is consistent with the external contour of the mitral valve prosthesis valve (309).

[0041] In a fourth aspect, the application provides a method for operating the system, comprising the following steps:

[0042] Step 1): using the biological ring assisted forming system to create a guideable channel for the biological ring:

[0043] The biological ring assisted forming system (200) is used to implant the biological ring guide wire (201) into the annular space of the mitral valve to form a channel; the biological ring assisted forming system (200) in the annular space of the mitral valve is composed of a plurality of deformable biological ring guide wires (201); one end of the biological ring guide wire (201) has a specially shaped hook (202), and the other end can be collected in an external catheter delivery system (203); when the biological ring guide wire (201) is completely implanted, the specially shaped hook (202) can tightly adhere to the inner wall of the annular space of the mitral valve, so that the annular space of the mitral valve forms a track (channel) to ensure the smooth passage of the biological ring; the biological ring assisted forming system (200) is implanted through the apex (204) by the external catheter delivery system (203); after implantation, the biological ring assisted forming system (200) is gradually pushed out and stretched by external operation, and the biological ring guide wire (201) forms a channel in the annular space of the mitral valve after being completely pushed out; the specially shaped hook (202) of the biological ring guide wire (201) is made of a non-transmissive material and can be clearly visible under external imaging, which facilitates the operation of medical personnel and the implantation of the biological ring.

[0044] Step 2): biological ring implantation:

[0045] The biological ring is guided into the mitral annular space along the guide of the biological ring assisted forming system (200); in the present application, the outer thread of the locking tip (101) of the biological ring is matched with the inner thread of the biological ring locking ring, and both are set to 30°, which can make the biological ring locking tip more conveniently enter the biological ring locking ring, and the operator can operate conveniently; the other side of the thread is 90° with the central axis, and the purpose is that the outer thread of the biological ring locking tip (101) cannot be withdrawn from the inner thread of the biological ring locking ring (102);

[0046] Step 3): Mitral valve prosthesis and delivery implantation and cutting: the mitral valve prosthesis stent and the matched valve are delivered and released by the transapical delivery method or the transseptal delivery method, so that the mitral valve prosthesis stent is fixed in the biological ring;

[0047] Wherein, the mitral valve prosthesis stent (300) with the cutting piece (306) is implanted into the ventricle by the transapical delivery method or the transseptal delivery method. The ear-shaped anchor at the connecting part of the stent middle recess layer (313) is specially provided with a cutting piece (306) for cutting the anterior leaflet of the mitral valve, and the left ear-shaped anchor (302) and the right ear-shaped anchor (303) are the key components for cutting the mitral valve. When cutting the shape, the left ear-shaped anchor (302) and the right ear-shaped anchor (303) can pass through the chordae tendineae of the mitral valve, be in the middle of the two chordae tendineae, and be drawn upward to cut the anterior leaflet of the mitral valve into a small slit.

[0048] The operation method provided by the present application sets up a foundation for the subsequent work by ring making, cutting, biological ring implantation, and mitral valve prosthesis and delivery implantation. In the biological ring implantation step, the biological ring enters the mitral annular space under the guidance of the biological ring assisted forming system (200), which provides conditions for the fixation of the subsequent implantation of the mitral valve prosthesis. In the implantation of the mitral valve prosthesis and delivery, the cutting step can effectively solve the problem of blood flow obstruction caused by the original mitral valve after the implantation of the prosthesis. In addition, the biological ring can enter the middle recess layer of the mitral valve prosthesis stent, so that the fixation of the mitral valve prosthesis and the original diseased mitral valve of the human body is more reliable, effectively solves the problem of extrusion of the left ventricular outflow tract when the mitral valve stent is released and deformed, and the biological ring can effectively seal the annular space between the mitral valve prosthesis and the atrioventricular passage, so that the blood flow flows into the left ventricle from the middle passage of the mitral valve prosthesis valve, and the size of the biological ring can be adjusted to a more appropriate diameter by the delivery catheter system, thereby more reliably fixing and sealing the mitral valve prosthesis, so that the operation method of the present application can firmly anchor, reliably seal, and smoothly flow when the mitral valve is implanted.

[0049] As a further improvement, in the operation method,

[0050] The trans-septal delivery method comprises: the compressed mitral valve prosthesis stent and valve in the delivery head and the guide wire are used to enter the right atrium from the vena cava, continue to puncture the atrial septum to enter the left atrium, and then release the mitral valve prosthesis stent and valve;

[0051] The trans-septal delivery method comprises: the compressed mitral valve prosthesis stent and valve in the delivery head and the guide wire are used to enter the right atrium from the vena cava, continue to puncture the atrial septum to enter the left atrium, and then release the mitral valve prosthesis stent and valve;

[0052] Wherein, after the trans-septal delivery is completed, the method for releasing the cutting piece (306) of the mitral valve prosthesis stent (300) is operated by the external catheter delivery system. First, the left fibrous trigone alignment element (311), the right fibrous trigone alignment element (312) and the top lotus layer front leaflet part (308) of the top lotus layer (310) of the mitral valve prosthesis stent are exposed first, and the alignment elements are adjusted and aligned under the observation of the fluoroscopy technology. Then the positions where the left ear-shaped anchor (302) and the right ear-shaped anchor (303) are located are exposed, the left ear-shaped anchor (302) and the right ear-shaped anchor (303) are unfolded, and the cutting piece (306) is exposed to form a shearing shape.

[0053] Wherein, after the trans-septal delivery is completed, the method for releasing the cutting piece (306) of the mitral valve prosthesis stent (300) is operated by the external catheter delivery system. First, the left fibrous trigone alignment element (311), the right fibrous trigone alignment element (312) and the top lotus layer front leaflet part (308) of the top lotus layer (310) of the mitral valve prosthesis stent are exposed first, and the alignment elements are adjusted and aligned under the observation of the fluoroscopy technology. Then the positions where the left ear-shaped anchor (302) and the right ear-shaped anchor (303) are located are exposed, the left ear-shaped anchor (302) and the right ear-shaped anchor (303) are unfolded, and the cutting piece (306) is exposed to form a shearing shape.

[0054] The stent is pulled to the atrial direction by the external catheter system, so that the biological ring is located at the position of the leaflet root of the human mitral valve. At this time, the biological ring locking sharp end (101) of the biological ring (100) is continuously pushed into the inside of the biological ring locking ring (102) by using the catheter system for controlling the size of the biological ring, so that the biological ring (100) is more tightly surrounded around the middle concave layer (313) of the stent. At this time, the human mitral valve is reliably fixed under the action of the biological ring and the middle concave layer (313) of the stent.

[0055] Continue to release the stent bottom support layer (314), at this time the mitral valve prosthesis (309) is expanded outward to a relaxed state, at the same time, the left ear-shaped anchor (302) and the right ear-shaped anchor (303) will the human original disease mitral valve slit support open, thereby capturing the natural anterior leaflet and chordae tendineae between the left ear-shaped anchor and the right ear-shaped anchor and the mitral valve prosthesis stent, and the delivery work is completed.

[0056] The embodiment of the present application utilizes a biological ring assisted forming system, and inserts a biological ring capable of locking and fixing a mitral valve prosthesis stent. The biological ring can enter a middle recessed layer of the mitral valve prosthesis stent, so that the fixation of the mitral valve prosthesis to the human original disease mitral valve is more reliable, and the problem of extrusion of the left ventricular outflow tract when the mitral valve stent is released is effectively solved. The biological ring can effectively seal the annular space between the mitral valve prosthesis and the atrioventricular passage, so that blood flows into the left ventricle from the middle passage of the mitral valve prosthesis. The embodiment of the present application utilizes specially designed cutting pieces on the mitral valve prosthesis stent to cut the human original disease mitral valve, which can effectively solve the problem of blood flow blockage caused by the original mitral valve after the prosthesis is implanted, and the problem of left ventricular outflow obstruction. In addition, the ear-shaped anchors on the mitral valve prosthesis stent can support and open the cut human original disease mitral valve slit, and open the blood flow passage between the dilated mitral valve and the aortic valve. The present application summarizes the basic structure, basic operation steps and methods of the biological ring insertion, mitral valve cutting and mitral valve prosthesis stent and valve, etc. The catheter-based mitral valve cutting, replacement and anchoring system and method are simple to operate, save operation time, and enable the operation to be safely and efficiently completed.

[0057] In view of the problems of unreliable fixation, poor sealing, extrusion of the left ventricular outflow tract by the mitral valve stent when released, easy obstruction and thus affecting the implantation effect after the mitral valve prosthesis is implanted, the embodiment of the present application provides a biological ring capable of fixing a mitral valve prosthesis stent and a matched biological ring assisted forming system. The biological ring assisted forming system provides preparation work for the next step of biological ring insertion. The biological ring assisted forming system can include a plurality of deformable biological ring guide wires, which are made of a memory metal (such as nickel-titanium alloy). The memory metal can deform between a low-temperature shape and a high-temperature shape according to different temperatures, that is, shape change occurs when the blood temperature in the blood vessel is sensed. The system can form a guiding track composed of a plurality of top hooks of the biological ring delivery wires around the annular space of the mitral valve.

[0058] In addition, the embodiment of the present application provides a biological ring implantation system, which can include a biological ring made of a material with good biocompatibility, and the diameter of the biological ring can range from 4 to 6 cm. The biological ring is formed by extruding both ends of the biological ring by a delivery catheter system, and the two ends can have inner locking teeth and outer locking teeth, respectively. When extruding, the inner locking teeth enter the outer locking teeth to lock the ring. After the biological ring is formed, the external catheter delivery system can be temporarily withdrawn from the heart chamber of the human body. After the mitral valve prosthesis is implanted in the corresponding position, the size of the biological ring can be adjusted to a more suitable diameter by the delivery catheter system, and the mitral valve prosthesis can be more reliably fixed and sealed.

[0059] After the implantation of the mitral valve prosthesis, the original mitral valve leaflet is supported by the stent, and the large area of the anterior leaflet is wrapped around the stent, which blocks part of the blood flow due to the large area, thereby causing left ventricular outflow obstruction. The embodiment of the present application provides a mitral valve shearing system. After the transapical implantation of the mitral valve prosthesis, the ear-shaped anchoring part is gradually opened, and a cutting piece for shearing the anterior leaflet of the mitral valve is arranged at the connection position between the ear-shaped anchoring part and the middle recessed layer of the stent. The cutting piece is a key component for shearing and supporting the mitral valve. In the shearing position, the ear-shaped anchoring part can pass through the chordae tendineae of the mitral valve between the two chordae tendineae and draw upward to cut the anterior leaflet of the mitral valve into a small seam. After the original human disease of the mitral valve is supported by the ear-shaped anchoring part of the mitral valve prosthesis stent, the expansion Slit effect makes the original human disease of the mitral valve and the chordae tendineae not wrapped around the outer periphery of the mitral valve prosthesis stent, so that the blood flow channel formed by the mitral valve prosthesis is more unobstructed, thereby inhibiting the obstruction of the left ventricular outflow tract and reducing the mortality rate.

[0060] The application also provides a mitral valve prosthesis stent and valve and implantation method. The shape of the upper part of the stent is similar to lotus, and can tightly adhere to the wall of the upper end of the mitral valve in the left atrium when the stent is opened, preventing the impact of blood flow. In order to prevent the lotus layer from pressing the aorta when the stent is released and opened, a front leaflet part is arranged in front of the lotus layer, which coincides with the position of the original human mitral valve. The stent can be provided with a middle recessed layer, and the diameter range is also 4-6 mm, which is matched with the diameter of the biological ring in the above ring placement system. When the biological ring is released and opened, it will enter the middle recessed layer and be clamped tightly. Due to the clamping and fixing effect of the biological ring on the mitral valve prosthesis, the mitral valve prosthesis will not fall off with the beating of the heart or the influence of blood flow, or press the left ventricular outflow tract, causing obstruction. In addition, the lower end of the stent can be slightly wider than the waist recess, and when the stent is opened, it can support the cut human original diseased mitral valve, and the part of the human original diseased mitral valve to the aortic valve part forms a smooth blood flow channel. In addition, in order to make the mitral valve stent align with the anatomical structure of the human original diseased mitral valve when implanted, a radio-opaque alignment element is arranged. In order to make the mitral valve prosthesis stent support and fix the cut human original diseased mitral valve cut by the above cutting system when released, two ear-shaped anchor pieces are arranged, the angle of the ear-shaped anchor piece is radially outwardly extended, and from the upper part of the stent, the ear-shaped anchor piece points to the upstream left atrial end of the human original diseased mitral valve. The ear-shaped anchor piece is provided with a plurality of spines, so that the fixation of the human original diseased mitral valve is more stable.

[0061] The implantation method of the mitral valve prosthesis stent and valve includes a transapical delivery method and a transseptal delivery method. In the above two delivery systems, in the transseptal delivery method, the lower end of the prosthesis stent in the left ventricular part (i.e. the support layer of the mitral valve prosthesis stent) can be released first, i.e. fine adjustment is made to move upward, so that the middle recessed layer of the mitral valve prosthesis stent is located at the root of the human original diseased mitral valve as much as possible, and then the left atrial prosthesis part (i.e. the top lotus layer of the mitral valve prosthesis stent) is released. BRIEF DESCRIPTION OF DRAWINGS

[0062] In the drawings, the same reference numerals in different views represent the same parts, and highlight the principles of the application. Details in the drawings are simplified, such as the simplified omission of the chordae tendineae of the mitral valve.

[0063] Figure 1 is a biological ring related schematic diagram of the embodiment of the disclosure, (wherein, Figure 1 a shows the outer shape structure of the biological ring; Figure 1 b shows that the biological ring forms a locking buckle in the working state; Figure 1 c shows that the 30° thread tooth outside the locking tip of the biological ring and the inside of the locking ring);

[0064] Figure 2 is a biological ring auxiliary forming system related schematic diagram of the embodiment of the disclosure (wherein,Figure 2 a shows a biological ring assisted forming system composed of a plurality of biological rings introduced into a wire; Figure 2 b shows the correct position of the biological ring assisted forming system in the annular space of the mitral valve; Figure 2 c shows the position of the biological ring assisted forming system in the annular space of the original human pathological mitral valve after being implanted through the heart apex; Figure 2 d shows a schematic diagram of the gradual unfolding of the biological ring assisted forming system in the ventricle after being implanted through the heart apex; Figure 2 e shows that the biological ring gradually enters the channel of the biological ring assisted forming system after the biological ring assisted forming system is formed; Figure 2 f shows that the biological ring gradually enters the channel of the biological ring assisted forming system to form an annular structure after the biological ring assisted forming system is formed in the ventricle);

[0065] Figure 3 are related schematic diagrams of the mitral valve prosthesis before and after release (wherein, Figure 3 a shows that the mitral valve prosthesis enters the central blood flow channel in the center of the mitral valve; Figure 3 b shows that the ear-shaped anchor piece of the mitral valve prosthesis is released, and there are cutting knives and spines on the ear-shaped anchor piece; Figure 3 c shows that after the ear-shaped anchor piece of the mitral valve prosthesis is released, the ear-shaped anchor piece is inserted into the gap between the two chordae tendineae facing the aortic part, and the mitral valve prosthesis is continuously pushed upward, and the anterior leaflet part of the mitral valve is cut);

[0066] Figure 4 are related schematic diagrams of the mitral valve prosthesis (wherein, Figure 4 a shows a schematic diagram of the structure of the mitral valve prosthesis stent and valve; Figure 4 b shows a schematic diagram of the mitral valve prosthesis stent and valve observed from the inclined top, aiming to distinguish the top lotus layer anterior leaflet part of the mitral valve prosthesis stent, the shape and position of the non-transmissive alignment element; Figure 4 c shows the position of the alignment element and the ear-shaped anchor of the mitral valve prosthesis in the human mitral valve, and a schematic diagram of the ear-shaped anchor opening the original pathological mitral valve incision in the human body after being released; Figure 4 d shows the position of the mitral valve prosthesis stent and valve in the human mitral valve when being released and opened, so as to form a smooth blood flow channel);

[0067] Figure 5 are schematic diagrams of the delivery of the mitral valve prosthesis (wherein, Figure 5 a shows a transapical mitral valve prosthesis delivery method; Figure 5 b shows a transseptal mitral valve prosthesis delivery method; Figure 5c shows that after completing the cutting of the native mitral valve of the human body, the implantation of the biological ring, and the implantation of the mitral valve prosthesis, a stable and unobstructed blood flow channel is formed between the left atrium and the left ventricle, and between the left ventricle and the aorta, maintaining the normal shape and function of the heart. DETAILED DESCRIPTION

[0068] The channel type mitral valve prosthesis implantation system and operation method provided by the present application are used to solve the problems of firm anchoring, reliable sealing, and outflow tract patency during the implantation of a mitral valve prosthesis. According to the implementation steps and system functions, the embodiments disclosed herein relate to the following systems: a biological ring system (a-1c), a biological ring auxiliary shaping system (a-2f), a mitral valve cutting system (a-3c), a mitral valve prosthesis system (a-4d), and a mitral valve prosthesis delivery and implantation method (a-5b). Figure 1 a- Figure 1 c), a biological ring auxiliary shaping system (a-2f), a mitral valve cutting system (a-3c), a mitral valve prosthesis system (a-4d), and a mitral valve prosthesis delivery and implantation method (a-5b). Figure 2 a-2f), a mitral valve cutting system (a-3c), a mitral valve prosthesis system (a-4d), and a mitral valve prosthesis delivery and implantation method (a-5b). Figure 3 a-3c), a mitral valve prosthesis system (a-4d), and a mitral valve prosthesis delivery and implantation method (a-5b). Figure 4 a-4d). The mitral valve prosthesis delivery and implantation method is shown in Figure 5 a-5b.

[0069] First, according to the embodiments of the present disclosure, the present application discloses a channel type mitral valve prosthesis implantation system, which comprises:

[0070] The biological ring auxiliary shaping system 200 comprises a plurality of deformable biological ring guide wires 201, the end of the biological ring guide wire has a hook 202, the biological ring guide wire 201 is uniformly distributed around the central axis at 360°, and the biological ring guide wire 201 is made of a memory metal (such as nickel-titanium alloy). The memory metal can deform between a low-temperature shape and a high-temperature shape with different temperatures, that is, the shape changes when it is subjected to the temperature of the blood in the blood vessel.

[0071] One end of the biological ring guide wire 201 has a specially shaped hook 202, and the other end can be collected in an external catheter delivery system 203. (The biological ring guide wire is a wire itself at low temperature, and only after being implanted in the mitral annular space, its end will be bent and deformed to form a hook under the influence of the temperature of the blood); when the biological ring guide wire 201 is completely implanted by using the external catheter delivery system, the specially shaped hook 202 can tightly adhere to the inner wall of the mitral annular space, so as to form a guidable channel that ensures the smooth implantation and ring formation of the biological ring in the mitral annular space.

[0072] The biological ring implantation system: as Figure 1As shown, the biological ring implant system mainly comprises a biological ring 100, which comprises a biological ring locking tip 101, a biological ring locking ring 102, a first biological ring (on the side of the biological ring locking tip) 103, a second biological ring (on the side of the biological ring locking ring) 104, and the first biological ring 103 and the second biological ring 104 are integrally connected between the end of the first biological ring 103 and the end of the second biological ring 104 away from the biological ring locking tip 101 and the biological ring locking ring 102 (the adjacent ends of the first biological ring 103 and the second biological ring 104 are integrally connected, in other words, the biological ring locking tip 101 and the second biological ring 104 are a whole), the first biological ring and the second biological ring are originally in the shape of a strip, and here they are expressed as the first biological ring and the second biological ring for convenience of expression and display. The front end of the biological ring locking tip 101 is in the shape of a tip, and the outer periphery of the rear end has external threads, which can facilitate the entry of the biological ring locking ring 102. The rear end of the biological ring locking tip is fixedly connected to the end of the first biological ring 103. The external threads of the rear end of the biological ring locking tip 101 are in the shape of a pagoda. Correspondingly, the inner wall of the biological ring locking ring 102 is provided with internal threads which are adapted to the external threads on the biological ring locking tip. The internal threads and the external threads are in the shape of a pagoda. The biological ring locking tip 101 and the biological ring locking ring 102 are locked to form a biological ring locking buckle under the pushing of the first biological ring 103 and the second biological ring 104. Specifically, the first biological ring 103 and the second biological ring 104 are arranged in a catheter of an external catheter system. Under the pushing action of the external catheter system, the biological ring locking tip 101 and the biological ring locking ring 102 gradually approach each other. After approaching, the first biological ring 103 (on the side of the biological ring locking tip) and the second biological ring 104 (on the side of the biological ring locking ring) are continuously extruded, the biological ring locking tip 101 enters the inside of the biological ring locking ring 102 and is locked, forming a biological ring locking buckle 101 (102), as shown in Figure 1 b.

[0073] As Figure 1As shown in Figure c, the threaded side of the rear end of the bio-ring locking tip 101 forms a 30° angle with its central axis. Correspondingly, the threaded side of the internal thread of the bio-ring locking ring 102 also forms a 30° angle with its central axis. Under the guidance of the 30° tip, the bio-ring locking tip 101 will exert a pushing force and enter the bio-ring locking ring 102. Because the outer wall of the bio-ring locking tip 101 (i.e., its rear end) has threads forming a 30° angle with its central axis, and the inner wall of the bio-ring locking ring 102 also has threads forming a 30° angle with its central axis, the threads inside the bio-ring locking tip 101 and the bio-ring locking ring 102 cooperate with each other. Their function is to allow the bio-ring locking tip 101 to slide forward along the 30° stepped surface when it moves forward; however, when it moves backward, because the back side of the threads forms a 90° angle with its central axis, the threads have a blocking effect and cannot be pushed backward (similar to a cable tie).

[0074] The bio-ring system mainly includes a bio-ring 100, which comprises a bio-ring locking tip and a bio-ring locking ring. Guided by the bio-ring auxiliary forming system, the bio-ring locking tip and the bio-ring locking ring are locked together to form a bio-ring locking buckle, thereby forming a bio-ring that surrounds the root of the original mitral valve leaflets. The diameter of the bio-ring can be adjusted via a 30° thread, the purpose of which is to more reliably fix and seal the mitral valve prosthesis.

[0075] Mitral valve prosthesis: This embodiment provides a mitral valve prosthesis stent 300 capable of shearing. The mitral valve prosthesis stent 300 is a radially self-expanding tubular body. After reaching the corresponding position in the ventricle, it is externally operated to release the ear-shaped anchor, and a specially made sharp blade on the ear-shaped anchor is exposed to shear the mitral valve.

[0076] like Figure 4 As shown in Figure a, the mitral valve prosthesis stent 300 consists of a lotus-shaped top layer 310, a recessed middle layer 313, a bottom support layer 314, a left fiber triangular alignment element 311, a right fiber triangular alignment element 312, a left auricular anchor 302, a right auricular anchor 303, a slit 306, and an anterior leaflet 308 of the top lotus-shaped layer. It is anchored together with the mitral valve prosthesis 309 to achieve the function of the mitral valve prosthesis. The mitral valve prosthesis stent 300 can be manufactured from shape memory alloys (such as nickel-titanium alloys) through laser cutting, photochemical etching, etc., and can recover its corresponding shape when released after reaching the appropriate position.

[0077] like Figure 4As shown in FIG. 10A, the outer surfaces of the stent top lotus layer 310, the stent middle recessed layer 313 and the stent bottom support layer 314 are connected to form a radially self-expandable tubular body. The stent top lotus layer 310 is connected by a plurality of lotus petal-like filaments to form a ring-shaped flange. A front petal portion 308 is arranged at the front end of the stent top lotus layer 310. The front petal portion 308 is formed by three lotus petal-like filaments. The angle between the lotus petal-like filaments of the front petal portion 308 and the other filaments (forming the stent top lotus layer 310) is different. For example, the angle between the lotus petal-like filaments of the front petal portion 308 and the stent is 10°, while the angle between the other filaments and the stent is 45°. The reason for this arrangement is that the front petal portion corresponds to the aortic outlet of the ventricle. If the angle is 45°, it will affect the blood flow of the aorta. Due to the above reasons, the shape of the flange formed by the lotus petal-like filaments is not a regular circle, but similar to the letter D, which can better match the anatomical structure of the original lesion of the human body. Left and right fibrous trigone alignment elements 311 and 312 are arranged on the left and right sides of the front petal portion 308, respectively. The alignment elements have non-transparent treatment areas to facilitate observation under fluoroscopy during the operation. The position of the stent is calibrated so that the left fibrous trigone alignment element 311 is located near the left fibrous trigone and the right fibrous trigone alignment element 312 is located near the right fibrous trigone, thereby achieving precise release. The correct position of the stent top lotus layer 310 in the heart is the part of the natural mitral valve close to the inner wall of the left atrium.

[0078] The stent middle recessed layer 313 is connected by triangular filaments. The diameter of the flange formed thereby is smaller than that of the stent top lotus layer 310, so as to form a recessed annular groove in which the biological ring can be fixed. The correct position of the stent middle recessed layer 313 in the heart is the position of the natural mitral annulus where the biological ring is located.

[0079] The stent bottom support layer 314 is connected by triangular filaments. The diameter of the flange formed thereby is larger than that of the stent middle recessed layer 313. Left and right ear-shaped anchoring elements 302 and 303 are arranged on the stent bottom support layer 314 corresponding to the position of the front petal portion 308. The left and right ear-shaped anchoring elements 302 and 303 are respectively provided with cutting blades 306. Figure 4 As shown in FIG. 10A, the left and right ear-shaped anchoring elements 302 and 303 are respectively provided with a plurality of spines in the circumferential direction. Figure 4As shown in b, the auricular anchors (i.e., the left auricular anchor 302 and the right auricular anchor 303) are auriculars extending radially outward from the mitral valve prosthesis stent, and their orientation is set to be upward towards the atrium. The correct position of the stent base support layer 314 in the heart is: the portion near the left ventricular wall where the natural mitral valve is located.

[0080] The lotus-shaped layer 310 at the top of the support, the recessed layer 313 in the middle of the support, and the support layer 314 at the bottom of the support are connected and supported by columnar filaments.

[0081] like Figure 4 As shown in b, the mitral valve prosthesis stent 300 is viewed from the top. The angles of the three lotus-like filaments in the anterior leaflet portion 308 of the top lotus layer of the mitral valve prosthesis stent 300 differ from the angles of the other lotus-like filaments, forming a D-shape. The left fiber triangle alignment element 311 and the right fiber triangle alignment element 312 are located on the lotus-like filaments on the left and right sides of the anterior leaflet portion 308 of the top lotus layer, respectively, and their shapes can be annular. The mitral valve prosthesis 309 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 towards the ventricle. The three leaflets of the mitral valve prosthesis 309 have both 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, thereby reducing or eliminating valvular insufficiency. As mentioned above, the mitral valve prosthesis 309 has no valve covering at the suture site of the original diseased mitral valve to allow blood to flow freely.

[0082] like Figure 4 As shown in b, the mitral valve prosthesis stent 300 is viewed from the top. The mitral valve prosthesis stent 300 has a left auricular anchor 302 and a right auricular anchor 303. 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. This auricular anchor has multiple spines 307 (the number of spines in the auricular anchor shown is 12). Its purpose is that when the mitral valve prosthesis stent 300 is opened, the left auricular anchor 302 and the right auricular anchor 303 respectively support and open the crack on the original mitral valve. This ensures that the original mitral valve and related chordae tendineae are more closely and firmly distributed on the auricular anchor, preventing the blood flow channel created by the method of this invention through the crack of the original mitral valve from closing due to blood flow impact or other reasons.

[0083] like Figure 4As shown in FIG. b, the mitral valve prosthesis stent 300 and the mitral valve prosthesis valve 309 are connected together by the prosthesis valve suture support bar 315, the shape of the prosthesis valve suture support bar 315 is consistent with the external contour of the mitral valve prosthesis valve 309 (only a small part of the prosthesis valve suture support bar 315 at the stent bottom support layer 314 is shown in the figure), and the prosthesis valve suture support bar 315 is distributed with multiple suture points, which allow the valve prosthesis (such as pericardium) to be connected thereto. In this embodiment, the prosthesis valve is a tricuspid valve, so it includes three prosthesis valve suture support bars 315.

[0084] As shown in FIG. a, the prosthesis valve suture support bar 315 is connected to the prosthesis valve 309, and the prosthesis valve suture support bar 315 is distributed with multiple suture points, which allow the valve prosthesis (such as pericardium) to be connected thereto. Figure 4 As shown in FIG. c, the mitral valve prosthesis stent 300 is placed in the correct position, and the left fibrous trigone alignment element 311 and the right fibrous trigone alignment element 312 of the mitral valve prosthesis stent 300 are respectively placed at the left and right ends of the original mitral valve incision of the human body, so as to make the original mitral valve incision as much as possible in the central position, and make the left fibrous trigone alignment element 311 close to the left fibrous trigone and the right fibrous trigone alignment element 312 close to the right fibrous trigone. The left ear-shaped anchor 302 (the right ear-shaped anchor 303) is stretched into the original mitral valve incision of the human body after the release of the mitral valve prosthesis stent 300, and gradually extends and slowly expands the original mitral valve incision of the human body over time.

[0085] As shown in FIG. a, the prosthesis valve suture support bar 315 is connected to the prosthesis valve 309, and the prosthesis valve suture support bar 315 is distributed with multiple suture points, which allow the valve prosthesis (such as pericardium) to be connected thereto. Figure 4 As shown in FIG. d, the mitral valve prosthesis stent 300 and the mitral valve prosthesis valve 309 are implanted in the position of the mitral valve in the heart, and the alignment elements left fibrous trigone alignment element 311 and right fibrous trigone alignment element 312 of the mitral valve prosthesis stent 300 are respectively located in the left fibrous trigone and the right fibrous trigone of the original mitral valve of the human body, and the top lotus layer anterior leaflet part 308 is within the range between the left fibrous trigone and the right fibrous trigone. Due to the gentle angle, it does not press the tissue near the aorta, and can maintain the patency of the blood flow channel, thereby maintaining the normal structure and pumping function of each part of the heart (aortic valve, left ventricle, right ventricle, aorta, etc.).

[0086] The mitral valve prosthesis stent comprises a stent top lotus layer 310, a stent middle concave layer 313 and a stent bottom support layer 314 which are connected; the stent top lotus layer 310 is connected by a plurality of lotus petal-like filaments to form a ring-shaped flange, a top lotus layer front leaflet part 308 formed by a plurality of lotus filaments is arranged at the front end of the stent top lotus layer 310, a left fibrous trigone alignment element 311 and a right fibrous trigone alignment element 312 are respectively arranged on the left and right sides of the stent top lotus layer 310 at the top lotus layer front leaflet part 308, and a left ear-shaped anchor 302 and a right ear-shaped anchor 303 are arranged on the stent bottom support layer 314 corresponding to the position of the top lotus layer front leaflet part 308. The alignment elements can facilitate observation by medical staff to deliver the mitral valve prosthesis stent and its valve to the correct position and direction. The ear-shaped anchors facilitate fixation on both sides of the incision and open a more unobstructed blood flow path.

[0087] Secondly, in the second aspect, according to the system, the application further provides an operation method of the system, which is specifically as follows:

[0088] The embodiment provides an operation method of the channel type mitral valve prosthesis implantation system, which comprises the following steps:

[0089] Step 1): a channel for the biological ring is formed by using a biological ring assisted forming system:

[0090] As shown in Figure 2 a, the biological ring assisted forming system 200 is composed of a plurality of deformable biological ring introduction filaments 201, one end of the biological ring introduction filament 201 has a specially shaped hook 202, and the other end can be collected in an external catheter delivery system 203. As shown in Figure 2 b-2c, the biological ring assisted forming system 200 is delivered to the correct position through the apex 204 by using the external catheter delivery system, the biological ring introduction filament 201 is placed in the above-mentioned mitral annular space, the top specially shaped hook 202 of the biological ring introduction filament 201 is arranged in a 360° distribution around the central axis to form a channel composed of the top specially shaped hook 202, which has a guiding effect. This channel is the track of the biological ring system after being placed.

[0091] As shown in Figure 2As shown in Figure d, under the operation of the external catheter delivery system 203, the tubular material encasing the bio-ring guide wire 201 is delivered through the apex of the heart to a specific position via the bio-ring assisted forming system 200. Under external control, a specially shaped hook 202 is pushed out and exposed outside the tubular material, then gradually extends to fit tightly against the inner wall of the mitral valve annular space, forming a channel within the mitral valve annular space to ensure the smooth insertion and formation of the bio-ring. This channel, made of a radiation-sensitive material, is clearly visible under external imaging, facilitating the insertion of the bio-ring by medical personnel. (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.)

[0092] Step 2): Insertion of the biological ring:

[0093] The insertion of the bio-ring is mainly accomplished through the bio-ring-assisted molding system 200, such as... Figure 1 As shown in ac;

[0094] like Figure 2 As shown in Figure e, under the guidance of the bioring-assisted molding system 200, the bioring locking tip 101 and the bioring locking ring 102, under the action of external pushing force, enter the channel formed by the bioring-assisted molding system 200 and gradually meet. Under the continued action of external pressure, the bioring locking tip 101 enters the internal locking teeth of the bioring locking ring 102, and the two lock together to form a bioring locking buckle 101 (102); at this point, the bioring 100 is placed into the annular space at the root of the mitral valve, as shown in Figure e. Figure 2 As shown in f, the bio-ring surrounds the root of the original mitral valve leaflet. Then, the bio-ring assisted forming system 200 gradually retracts the bio-ring guide wire 201, which is then withdrawn from the body via the external conduit delivery system 203.

[0095] Step 3): Delivery and placement of the mitral valve prosthesis stent and its valve: The mitral valve prosthesis stent and the matching valve are fixed in the bio-ring: There are two delivery and release methods for the mitral valve prosthesis stent 300 and the mitral valve prosthesis valve 309: transapical delivery method and transseptal delivery method.

[0096] like Figure 5A method for transapical delivery of a mitral valve prosthesis stent 300 and a mitral valve prosthesis 309 is illustrated. The delivery device and system, comprising the mitral valve prosthesis stent and valve compressed into a contractile state, enter the heart transapically under the action of the delivery head and guidewire, overcoming interference from the chordae tendineae and papillary muscles, and passing through the left ventricle into the left atrium. Manipulating the delivery system first exposes the left fibrous trigone alignment element 311, the right fibrous trigone alignment element 312, and the anterior leaflet 308 of the top lotus layer 310 of the stent, as well as the auricular anchors (302 or 303), etc., on the mitral valve prosthesis stent 300. Under fluoroscopic observation, the physician can observe the light-blocking alignment elements, namely the left fibrous trigone alignment element 311 and the right fibrous trigone alignment element 312. By rotating the delivery device and system, the alignment elements are adjusted and aligned, and the stent is pulled upwards, causing the slicing blade 306 to cut the anterior leaflet portion of the mitral valve.

[0097] Specifically, such as Figure 3 As shown in Figure ac, the compressed mitral valve prosthesis stent 300 with slits 306 is placed in the corresponding position in the ventricle via transapical delivery. After the operator performs the procedure, the mitral valve prosthesis stent 300 releases the left / right auricular anchors (302 or 303) with slits 306 and spikes 307. At this time, the plane of the left / right auricular anchors (302 or 303) passes through the central axis of the self-expanding mitral valve prosthesis stent 300, and the slits 306 on the left / right auricular anchors (302 or 303) are perpendicular to the edge line of the anterior leaflet of the mitral valve. By pushing the self-expanding mitral valve prosthesis stent 300 upward, the slits 306 can shear the mitral valve, as... Figure 3 As shown in b. The left auricle-shaped anchor 302 and the right auricle-shaped anchor 303 are key components that enable mitral valve shearing. During shearing, the left auricle-shaped anchor 302 and the right auricle-shaped anchor 303 can pass through the mitral valve chordae tendons, between the two tendons 305, and slide upwards, cutting a small slit in the anterior leaflet of the mitral valve.

[0098] After cutting and alignment, the delivery device and system continue to contract, further exposing the mitral valve prosthesis stent 300. This completely removes the radial constraint of the lotus-shaped layer 310 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 313 of the stent continues to be exposed, allowing the mitral valve prosthesis 309 to expand further outward. The central recessed layer 313 expands to engage with the mitral valve annulus, and the expanded auricular anchors enter the mitral valve suture 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 so that the unexpanded left auricular anchor 302 and right auricular anchor 303 enter the mitral valve suture of the original lesion. At this point, the outer part of the central recessed layer 313 is precisely inside the bio-ring 100.

[0099] After the human mitral valve is fixed under the action of the biological ring 100 and the middle concave layer 313 of the stent, the stent is pulled by the external catheter system towards the atrium, so that the biological ring 100 is located at the leaflet root position of the human mitral valve as much as possible. At this time, the catheter system for controlling the size of the biological ring 100 continues to push the biological ring locking tip 101 of the biological ring 100 into the internal locking teeth of the biological ring locking ring 102, so that the biological ring 100 is more tightly surrounded around the middle concave layer 313 of the stent. At this time, the human mitral valve is reliably fixed under the action of the biological ring 100 and the middle concave layer 313 of the stent, and will not be caused to slide off due to blood flow and the like.

[0100] Further shrinkage of the delivery device and system, and continuous release of the stent bottom support layer 314, at this time, the mitral valve prosthesis valve 309 is expanded to a relaxed state, and at the same time, the left ear-shaped anchor 302 and the right ear-shaped anchor 303 support the original human pathological mitral valve to be opened, so as to capture the natural anterior leaflet and chordae tendineae between the left ear-shaped anchor 302 and the right ear-shaped anchor 303 and the mitral valve prosthesis stent 300. After the delivery work is completed, the delivery device and system are withdrawn and removed from the heart apex incision, and then the heart apex incision is ligated and sutured.

[0101] As shown in Figure 5 b shows a method for trans-septal delivery of the mitral valve prosthesis stent 300 and the mitral valve prosthesis valve 309. The delivery device and system are provided with the mitral valve prosthesis stent 300 which is compressed to a contracted state. Under the action of the delivery head and the guide wire, the mitral valve prosthesis stent 300 is introduced into the right atrium from the vena cava, and then continues to puncture the atrial septum (usually through the oval foramen) to enter the left atrium. The release method and steps of the mitral valve prosthesis stent 300 and the mitral valve prosthesis valve 309 are similar to those of the trans-apical delivery method, and will not be described in detail.

[0102] As shown in Figure 5 After the above-mentioned biological ring assisted forming, mitral valve shearing, biological ring placement system and other working steps, a smooth blood flow passage is formed between the left atrium and the left ventricle of the heart, and the mitral valve prosthesis will not fall off due to the influence of heart beating or blood flow, so as to realize and maintain the normal structure and morphology of each part of the heart (such as the tissue near the aortic valve), as described above, the expansion and deformation of the mitral valve stent will not squeeze the left ventricular outflow tract, and the original anterior leaflet of the mitral valve will not block the blood flow, avoiding causing left ventricular outflow tract obstruction and the like, and realizing the normal blood pumping function of the heart.

[0103] The above-mentioned specific embodiments are only a preferred embodiment of the present application patent, but cannot limit the scope of the present application patent. Therefore, the equivalent changes made according to the claims of the present application patent still fall within the scope of the present application patent.

Claims

1. A trans-catheter mitral valve prosthesis implantation system, characterized in that: The system comprises: a plurality of deformable biological ring guide wires, each of the plurality of biological ring guide wires having a bendable hook at an end of the biological ring guide wire, the hooks being used to form a guideable channel; the biological ring guide wire is a single wire at low temperature, and only after being placed in the annular space of the mitral valve, the end of the biological ring guide wire is deformed to form a hook under the influence of the temperature of the blood; a biological ring, the biological ring being in the shape of a strip when free, two free ends of the biological ring being configured to be locked to form a biological ring locking buckle when a main part of the biological ring is pushed along the channel, the biological ring comprising a biological ring locking tip, a biological ring locking ring, a first biological ring and a second biological ring, the first biological ring and the second biological ring being connected, a front end of the biological ring locking tip being in the shape of a tip, a rear end of the biological ring locking tip having an outer thread on a periphery of the rear end, and the rear end of the biological ring locking tip being fixedly connected to an end of the first biological ring, the biological ring locking ring being fixedly connected to an end of the second biological ring, an inner wall of the biological ring locking ring being provided with an inner thread matched with the outer thread, the biological ring locking tip being used to enter the biological ring locking ring to form the biological ring locking buckle, one side of a thread of the outer thread of the biological ring locking tip being 30° to a central axis of the biological ring locking tip, and one side of a thread of the inner thread of the biological ring locking ring being 30° to a central axis of the biological ring locking ring; a mitral valve prosthesis stent, the mitral valve prosthesis stent being fixed in the biological ring, the mitral valve prosthesis stent being a radial self-expanding tubular body, comprising a stent top lotus layer, a stent middle recessed layer and a stent bottom support layer connected in communication, the stent bottom support layer being provided with left / right ear-shaped anchoring members, and each of the left / right ear-shaped anchoring members being provided with a cutting piece, and the stent middle recessed layer being fixed in the biological ring.

2. The system of claim 1, wherein: The plurality of biological ring guide wires are distributed around the central axis at 360°, and the biological ring guide wires are made of a memory metal.

3. The system according to claim 1, wherein: a stent top lotus layer front leaflet part is arranged at a front end of the stent top lotus layer, left / right fiber triangular area alignment elements are respectively arranged on the stent top lotus layer on left and right sides of the stent top lotus layer front leaflet part, and the left / right ear-shaped anchoring members are arranged on the stent bottom support layer at positions corresponding to the stent top lotus layer front leaflet part; the left / right ear-shaped anchoring members are respectively provided with a plurality of spines in respective circumferential directions; the left / right ear-shaped anchoring members are ear pieces extending radially outward from the mitral valve prosthesis stent, and directions of the left / right ear-shaped anchoring members are set to be upwardly inclined; angles between wire-like objects constituting the stent top lotus layer front leaflet part and a central axis of the mitral valve prosthesis stent are 10°, and angles between wire-like objects constituting the stent top lotus layer and the central axis of the mitral valve prosthesis stent are 45°.

4. The system of any of claims 1-3, wherein: the system further comprises a valve matched with 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, a shape of the prosthesis valve suture support strip is consistent with an outer contour of the mitral valve prosthesis valve.

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