CN114939005A

CN114939005A - Rail type mitral valve prosthesis implantation system and operation method thereof

Info

Publication number: CN114939005A
Application number: CN202210337289.0A
Authority: CN
Inventors: 蹇朝; 肖颖彬; 平璐璐
Original assignee: Second Affiliated Hospital of Army Medical University
Current assignee: Second Affiliated Hospital of Army Medical University
Priority date: 2022-04-01
Filing date: 2022-04-01
Publication date: 2022-08-26
Anticipated expiration: 2042-04-01
Also published as: CN114939005B

Abstract

The invention discloses an orbital mitral valve prosthesis implantation system and an operation method thereof. The orbital mitral valve prosthesis implantation system includes a mitral valve annular space annulation device, which includes a first deformable The conveying wire and the second deformable conveying wire, the end of the first deformable conveying wire is fixed with the magnetic ball to be captured, the end of the second deformable conveying wire is fixed with the capturing magnetic ball, and the first/second deformable conveying wire is used for The magnetic balls with different magnetic properties attract each other to form a guiding channel; the biological ring is in the shape of a strip when it is freely stretched, and the two free ends of the biological ring are configured so that when the main part of the biological ring is pushed along the guiding channel, the two free ends The ends are locked to form a biological ring locking buckle; the mitral valve prosthesis stent is a radial self-expanding tubular body, and the mitral valve prosthesis stent includes a connected lotus layer on the top of the stent and a concave layer in the middle of the stent. and the bottom support layer of the bracket; the left/right ear-shaped anchors are arranged on the bottom support layer of the bracket.

Description

Rail-type mitral valve prosthesis implantation system and operation method thereof

Technical Field

The invention relates to a transcatheter mitral valve prosthesis stent and a valve implantation method, in particular to a track type mitral valve prosthesis implantation system and an operation method thereof.

Background

With the social development trend of aging in China, the incidence of senile valve degenerative disease is continuously increased, wherein the left heart function is gradually reduced due to mitral valve degenerative disease. For patients with severe mitral valve disease, surgical mitral valve replacement is the only treatment method capable of prolonging life, but old patients are often contraindicated due to old age, weak constitution, severe disease or other diseases. Transcatheter mitral valve placement is now an effective treatment for patients at high risk or who have cardiac surgical contraindications.

Mitral valve replacement is a cardiac surgical procedure that replaces a diseased or abnormal mitral valve with a prosthetic valve, and is mainly indicated for mitral stenosis, severe calcification of the valve, or mitral regurgitation. The existing method mainly has the following main problems: the anchoring of the mitral valve prosthesis is unreliable after the mitral valve prosthesis is placed, and the sealing is not tight; the mitral valve support expands and deforms to extrude the left ventricular outflow tract, and the original anterior valve blocks partial blood flow, so that the left ventricular outflow tract is obstructed and the like.

Therefore, there is a strong need for a system and method that solves the problems of secure anchoring, reliable sealing, smooth passage, etc. when implanting a mitral valve.

Disclosure of Invention

In view of the technical problems in the prior art, the present application provides an orbital mitral valve prosthesis implantation system.

An orbital mitral valve prosthesis implantation system comprising

The mitral annular space annuloplasty device comprises a first deformable wire and a second deformable wire, wherein one end of the first deformable wire is fixed with a magnetic ball to be captured, one end of the second deformable wire is fixed with a capture magnetic ball which is different from the magnetic ball to be captured, and the first deformable wire or the second deformable wire is used for forming an annular guide channel under the mutual attraction of the magnetic balls different in magnetism;

a bio-ring in the shape of a strip when freely extended, the two free ends of the bio-ring being configured to lock when the body portion of the bio-ring is pushed along the guide channel to form a bio-ring clasp;

the mitral valve prosthesis stent is a radial self-expanding tubular body and comprises a stent top lotus flower layer, a stent middle concave layer and a stent bottom supporting layer which are communicated; a left/right ear-shaped anchoring part is arranged on the supporting layer at the bottom of the bracket; the support middle concave layer is fixed in the biological ring.

As a further improvement, the first and second deformable feed wires are made of a memory metal.

As a further improvement scheme, a through hole for the first/second deformable conveying wires to pass through is formed in the biological ring along the length direction of the biological ring; the both ends of biological ring are established respectively to biological ring lock point end and biological ring lock ring, biological ring lock point end has the external screw thread, and biological ring lock ring is inside to be seted up with the internal thread of external screw thread looks adaptation, and biological ring lock point end is used for getting into biological ring lock ring and forms biological ring lock is detained.

As a further improvement, the front end part of the biological ring locking tip is designed into a tip structure, and the outer periphery of the rear end part is provided with the external thread; the thread side of the external thread of the biological ring locking tip forms a 30-degree angle with the central axis, and the thread side of the internal thread of the biological ring locking tip forms a 30-degree angle with the central axis.

As a further improvement, the left/right ear-like anchors are provided with a plurality of thorns on respective circumferential directions;

the left/right ear anchors are tabs that extend radially outward from the mitral valve prosthesis stent and their orientation is set to be inclined upward.

As a further improvement scheme, a top lotus layer front leaflet part is arranged at the front end part of a lotus layer at the top of the bracket, a left fiber triangular area aligning element and a right fiber triangular area aligning element are respectively arranged on the lotus layer at the top of the bracket at the left side and the right side of the lotus layer front leaflet part at the top, and the left/right ear-shaped anchoring part is arranged on a supporting layer at the bottom of the bracket corresponding to the position of the lotus layer front leaflet part at the top;

the angle between the filaments forming the front leaflet part of the top lotus layer and the central axis of the mitral valve prosthesis bracket is 10 degrees, and the angle between the filaments forming the top lotus layer of the bracket and the central axis of the mitral valve prosthesis bracket is 45 degrees.

As a further improvement, the system also comprises a valve matched with the mitral valve prosthesis bracket, the mitral valve prosthesis bracket 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.

The application also discloses a mitral valve prosthesis stent which is a radial self-expanding tubular body and comprises a stent top lotus layer, a stent middle concave layer and a stent bottom supporting layer which are communicated with each other; and a left ear-shaped anchoring part and a right ear-shaped anchoring part are arranged on the supporting layer at the bottom of the bracket.

As a further improvement scheme, a front leaflet part of the top lotus layer is arranged at the front end part of the top lotus layer of the bracket, left/right fiber triangular zone aligning elements are respectively arranged on the lotus layer at the top of the bracket at the left and right sides of the front leaflet part of the top lotus layer, and a left ear-shaped anchoring part and a right ear-shaped anchoring part are arranged on a supporting layer at the bottom of the bracket below the front leaflet part of the top lotus layer; the left and right ear anchors are shown with a plurality of barbs disposed circumferentially on each.

As a further improvement, the system further comprises a laser cutter or a cutting knife, preferably, the laser cutter comprises a laser conduction optical fiber, a conversion connector, an angle adjusting short section, a connector, a cutter head and an angle adjusting line; the laser conduction optical fiber is connected with the angle adjusting short section through the conversion connector, the angle adjusting short section is connected with the cutter head through the connector, all the connections are threaded, and sealing can be achieved; the two ends of the angle adjusting line are fixedly connected with the outer walls of the conversion connector and the connector respectively so as to adjust the angle of the blade conveniently.

The application also discloses an operation method of the system, which comprises the following steps:

step 1): creating a steerable tunnel for the bio-ring: the deformable wire conveying outer sleeve and the mitral valve annular space ring making device are placed into the mitral valve annular space by an external catheter conveying system, under the guidance of the deformable wire conveying outer sleeve, a second deformable wire conveying sleeve and a first deformable wire conveying sleeve are pushed in the mitral valve annular space, a magnetic ball is captured, and the magnetic ball to be captured is attracted mutually to form a capture buckle joint, so that the first deformable wire conveying sleeve forms a circular annular guide channel surrounding the root of the mitral valve leaflet;

step 2): the biological ring is implanted to form an annular structure surrounding the root of the mitral valve: pushing the biological ring along the channel in the step 1) to lock two ends of the biological ring to form a biological ring locking buckle, so that the biological ring is placed into an annular space at the root of the mitral valve and surrounds the root of the mitral valve;

step 3): mitral valve prosthesis delivery placement: the compressed mitral valve prosthetic stent is delivered to the left atrium by transapical or transseptal delivery, releasing the mitral valve prosthetic stent and securing its stent medial recessed layer in the biologic ring.

The present application is further described below:

in a first aspect, the present application provides a biological ring implanting system for mitral valve prosthesis fixation, comprising a biological ring (300), a through hole for a first deformable delivery wire to pass through is opened inside the ring of the biological ring, the biological ring (300) comprises a biological ring locking tip (301), a biological ring locking ring (304), a first biological ring (302) and a second biological ring (303), adjacent ends of the first biological ring (302) and the second biological ring (303) are connected into a whole, a front end portion of the biological ring locking tip (301) is a tip structure, a rear end portion periphery of the biological ring locking tip is provided with an external thread, the rear end portion of the biological ring locking tip is fixedly connected with one end portion of the first biological ring (302), one end of the biological ring locking ring (304) is fixedly connected with an end portion of the second biological ring, an internal thread is opened on an inner wall of the biological ring locking ring (304), the internal thread is matched with the external thread at the rear end part of the biological ring locking tip, the biological ring locking tip (301) and the biological ring locking ring (304) are respectively pushed and locked by a first biological ring (302) and a second biological ring (303) under the guide of the ring body to form a biological ring locking buckle, so that a biological ring surrounding the root of the original mitral valve leaflet is formed, and the ring body is formed by wrapping the root of the original mitral valve leaflet by the first deformable wire feeding. The bio-ring implantation system provided by the application has the advantages that the diameter of the bio-ring completed by the system is adjustable, and the mitral valve prosthesis can be fixed and sealed more reliably.

As a further improvement, in the system for inserting the biological ring, the thread side of the external thread at the rear end part of the biological ring locking tip (301) forms a 30-degree angle with the central axis, and the thread side of the internal thread of the biological ring locking tip (304) forms a 30-degree angle with the central axis. The external screw thread with the most advanced back tip of locking of biological ring sets up and all sets to 30 with the internal thread looks adaptation of biological ring lock ring in this application, can make the most advanced more convenient biological ring lock ring of entering of biological ring lock, makes things convenient for operating personnel to operate.

As a further improvement, in the system for inserting a biological ring, the ring body is formed by looping a mitral annulus looping device, the mitral annulus looping device includes a capture magnetic ball 101, a to-be-captured magnetic ball 104, a first deformable feed wire 103, and a second deformable feed wire 105, a top end of the first deformable feed wire is fixedly connected to the to-be-captured magnetic ball, the capture magnetic ball 101 is fixedly connected to an end of the second deformable feed wire 105, and the to-be-captured magnetic ball 104 is used for capturing the capture magnetic ball 101 to form a capture buckle joint, and after the capture buckle joint is formed, the capture magnetic ball and the second deformable feed wire are pulled out of the body by the catheter system, so that the first deformable feed wire forms a ring body surrounding the root of the mitral valve leaflet. The ring body structure that this application set up sets up ingeniously, catches the magnetic ball through the setting, treats that it catches the knot joint to catch the magnetic ball formation, can make the defeated winding mitral valve leaflet root that send the silk of first deformable, this just facilitates for subsequent shearing to also put into for biological ring and provide the guide effect.

As a further improvement, in the system for inserting the bio-ring, the capturing magnetic ball and the magnetic ball to be captured have opposite-pole attractive magnetic force, so that the capturing magnetic ball and the magnetic ball to be captured can be smoothly attracted, connected and fixed after entering the mitral valve annular space, and an operator can accurately and quickly operate to complete preparation work of inserting the bio-ring and cutting the mitral valve.

In a second aspect, the present application provides a mitral valve prosthesis stent, which is a radial self-expandable tubular body, and the mitral valve prosthesis stent is fixed by the bio-ring in the bio-ring implantation system after being released, and comprises a stent top lotus layer (401), a stent middle concave layer (402) and a stent bottom support layer (403) which are communicated with each other;

the bracket comprises a bracket top lotus layer (401), a top lotus layer front leaflet part (409) formed by a plurality of lotus-like filaments is arranged at the front end part of the bracket top lotus layer (401), a left fiber triangular area aligning element (406) and a right fiber triangular area aligning element (405) are respectively arranged on the bracket top lotus layer (401) at the left side and the right side of the top lotus layer front leaflet part (409), and a left ear-shaped anchor (407) and a right ear-shaped anchor (408) are arranged on a bracket bottom supporting layer (403) corresponding to the position of the top lotus layer front leaflet part (409).

As a further improvement, in the mitral valve prosthesis stent, the angle between the filaments forming the top lotus layer anterior leaflet part (409) and the central axis of the mitral valve prosthesis stent (400) is 10 degrees, and the angle between the filaments forming the stent top lotus layer (401) and the central axis of the mitral valve prosthesis stent (400) is 45 degrees;

the support middle concave layer (402) is formed by connecting triangular filaments, and the diameter of a flange formed by connecting the triangular filaments is smaller than that of the lotus layer (401) at the top of the support so as to form a concave ring groove;

the support layer (403) at the bottom of the bracket is formed by connecting triangular wires, and the diameter of a flange formed by connecting the triangular wires is larger than that of the concave layer (402) at the middle part of the bracket;

the left and right ear anchors (407, 408) are tabs extending radially outward from the stent and oriented to slope upward toward the atrial portion; a plurality of thorns are respectively arranged downwards on the peripheral direction of the left ear-shaped anchor and the right ear-shaped anchor;

and each layer among the lotus layer (401) at the top of the bracket, the concave layer (402) at the middle of the bracket and the supporting layer (403) at the bottom of the bracket is connected and supported by a cylindrical silk.

In a third aspect, the present application provides an orbital mitral valve prosthesis implantation system comprising:

ring making: forming the first deformable wire into an annular body surrounding the root of the original mitral valve leaflet, wherein the diameter of the annular body is adjustable;

shearing: cutting the anterior valve from a position far away from the central axis of the mitral valve annulus to a position close to the central axis of the mitral valve annulus by using a laser cutter or a sharp cutter to obtain a mitral valve cutting slit;

placing a biological ring: leading a biological ring insertion system into a biological ring with adjustable diameter along the guide direction of the ring body, wherein the ring body of the biological ring is internally provided with a through hole for a first deformable conveying wire to pass through, the biological ring (300) comprises a biological ring locking tip (301), a biological ring locking ring (304), a first biological ring (302) and a second biological ring (303), the adjacent ends of the first biological ring (302) and the second biological ring (303) are connected into a whole, the front end part of the biological ring locking tip (301) is of a tip structure, the periphery of the rear end part is provided with an external thread, the rear end part of the biological ring locking tip is fixedly connected with one end part of the first biological ring (302), one end of the biological ring locking ring (304) is fixedly connected with the end part of the second biological ring, the inner wall of the biological ring locking ring (304) is provided with an internal thread, and the internal thread is matched with the external thread of the rear end part of the biological ring locking tip, the biological ring locking tip (301) and the biological ring locking ring (304) are respectively pushed and locked by a first biological ring (302) and a second biological ring (303) under the guidance of the ring body to form a biological ring locking buckle, so that a biological ring surrounding the root of the original mitral valve leaflet is formed;

mitral valve prosthesis and delivery placement: and fixing the mitral valve prosthesis stent and the matched valve in the biological ring.

As a further improvement, in the rail-type mitral valve prosthesis implanting system, the connection manner between the mitral valve prosthesis support and the valve is as follows: the mitral valve prosthesis bracket (400) is connected with the mitral valve prosthesis valve (404) through a prosthesis valve suture support strip (410), and the shape of the prosthesis valve suture support strip (410) is consistent with the external contour of the mitral valve prosthesis valve (404).

In a fourth aspect, the present application provides a method of operating an orbital mitral valve prosthesis implantation system, comprising the steps of:

step 1): ring making: forming a first deformable delivery wire into an annular body surrounding the root of the original mitral valve leaflet by using a mitral annulus annuloplasty device, wherein the annular body is a circular ring structure with an adjustable diameter, the mitral annulus annuloplasty device comprises a capture magnetic ball 101, a to-be-captured magnetic ball 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 with the to-be-captured magnetic ball 104, the capture magnetic ball 101 is fixedly connected with the end of the second deformable delivery wire 105, the to-be-captured magnetic ball 104 is used for capturing the capture magnetic ball 101 to form a capture buckle joint, and the capture buckle joint and the second deformable delivery wire 105 are pulled out of the body by a catheter system after being formed, so that the first deformable delivery wire 103 forms an annular body surrounding the root of the original mitral valve leaflet;

step 2): shearing:

comprising step 21): the two ends of the first deformable delivery wire 103 are sleeved together by a mitral valve closure adjusting catheter (208), the mitral valve closure adjusting catheter (208) is gradually pushed into the outside of the human body through a catheter system, the mitral valve closure adjusting catheter (208) is adjusted to be compressed to force the circumference of the annular body to be reduced, so that the annular body is contracted to adjust the closure of the original mitral valve (210) of the human body, and the original mitral valve is fixed to prepare for cutting;

step 22): cutting the anterior valve from a position far away from the central axis of the mitral valve annulus to a position close to the central axis of the mitral valve annulus by using a laser cutter or a sharp micro cutter (for convenience of expression, the laser cutter or the sharp micro cutter is called as a cutter), and after the cutting operation is finished, withdrawing the mitral valve closure adjusting catheter (208) to the outside of the body, so that the annular body formed by the first deformable wire (103) returns to the shape and the mitral valve slit is formed;

and step 3): placing a biological ring: leading in a biological ring with adjustable diameter size along the guide direction of the annular body by using the biological ring imbedding system;

step 4): mitral valve prosthesis and delivery placement: the mitral valve prosthesis stent and the matched valve are delivered and released by a transapical delivery method or a transseptal delivery method, so that the mitral valve prosthesis stent is fixed in the biological ring.

The operation method provided by the application comprises the following four steps of ring making, shearing, biological ring implanting, mitral valve prosthesis and delivery implanting, firstly, the ring making is used for laying a foundation for subsequent work, the shearing step can effectively solve the problems that the original mitral valve blocks blood flow after prosthesis implanting, the left ventricular outflow tract is obstructed and the like, in the biological ring implanting step, the biological ring enters a mitral valve annular space under the guidance of an annular body to provide a condition for the subsequent fixation of the mitral valve prosthesis after implanting, in the mitral valve prosthesis and the delivery implanting, the biological ring can enter a concave layer in the middle of a bracket of the mitral valve prosthesis, so that the fixation of the mitral valve prosthesis and the original diseased mitral valve of a human body is more reliable, the problem that the mitral valve prosthesis extrudes the left ventricular outflow tract when the bracket is released and deformed is effectively solved, and the biological ring can effectively seal the annular space between the mitral valve prosthesis and an atrioventricular passage, the mitral valve prosthesis can be fixed and sealed more reliably by the delivery catheter system, so that the mitral valve can be firmly anchored, sealed reliably and the passage is smooth when being implanted.

As a further improvement, in the operating method,

the transseptal delivery method in the step 4) comprises the following steps: the mitral valve prosthesis bracket and the valve which are compressed into a contracted state enter the right atrium from the vena cava under the action of the delivery head and the guide wire, continue to puncture the interatrial septum to enter the left atrium, and then release the mitral valve prosthesis bracket and the valve;

the transapical delivery method in step 4) comprises the following steps: the mitral valve prosthesis bracket and the valve which are compressed into a contraction state enter the heart through the apex of the heart under the action of the delivery head and the guide wire, enter the left atrium through the left ventricle, and then release the mitral valve prosthesis bracket and the valve;

wherein, after the delivery is completed through the heart apex, the method for releasing the mitral valve prosthesis stent and the valve comprises the following steps:

first exposing a left fibrous trigonal alignment element (406), a right fibrous trigonal alignment element (405) and a top lotus layer anterior leaflet portion (409) of a top lotus layer (401) of a mitral valve prosthesis stent; under the observation of the perspective developing technology, the alignment element is adjusted and aligned; after the alignment is adjusted, further exposing the mitral valve prosthesis stent (400), so that the radial constraint of the lotus layer (401) at the top of the stent is completely removed, and the lotus layer (401) at the top of the stent is allowed to self-expand to form a flange which is tightly attached to the surface of the atrium; continuing to expose the stent middle recessed layer (402), expanding the mitral valve prosthetic valve 404 more outward, expanding the stent middle recessed layer to be jointed with the mitral valve annulus, gradually entering the unexpanded ear-shaped anchoring piece into the original diseased mitral valve slit of the human body at the moment, and preparing for capturing and supporting tissues at two sides of the slit at the next step, wherein the outside of the stent middle recessed layer (402) is just inside the biological ring (300);

the bracket is pulled towards the atrium by the external catheter system, so that the biological ring is positioned at the root position of the mitral valve leaflet of the human body, and the catheter system controlling the size of the biological ring is utilized to continuously push the biological ring locking tip of the biological ring to enter the biological ring locking ring, so that the biological ring more tightly surrounds the middle concave layer of the bracket, and the mitral valve of the human body is reliably fixed under the action of the biological ring and the middle concave layer of the bracket;

continued release of the stent bottom support layer, at which point the mitral valve prosthetic valve expands outwardly into an expanded state, simultaneously with the left and right ear anchors (407, 408) spreading the body's native mitral valve slit open, capturing the native anterior leaflets and chordae tendineae between the left and right ear anchors and the mitral valve prosthetic stent, and the delivery is complete.

The mitral valve ring space is a ring-shaped three-dimensional space structure, which is composed of a mitral valve ring and a valve, and the biological ring can enter the ring-shaped space to form a complete biological ring.

The embodiment of the invention utilizes the biological ring implantation system to implant the biological ring device capable of locking and fixing the mitral valve prosthesis bracket, the biological ring can enter the concave layer in the middle of the bracket of the mitral valve prosthesis, so that the fixation of the mitral valve prosthesis and the original diseased mitral valve of a human body is more reliable, the problem that the mitral valve bracket extrudes a left ventricle outflow channel when releasing and deforming is effectively solved, and the biological ring can effectively seal the annular space between the mitral valve prosthesis and an atrioventricular channel, so that blood flows into the left ventricle from the middle channel of the mitral valve prosthesis valve. The embodiment of the invention utilizes the cutting knife to cut the original diseased mitral valve of a human body, and can effectively solve the problems that the original mitral valve blocks blood flow after the prosthesis is implanted, so that the outflow tract of the left ventricle is blocked, and the like. In addition, the mitral valve prosthesis bracket can open the sheared original diseased mitral valve of a human bodyJoint cuttingOpening a blood flow path between the dilated mitral valve and the aortic valve. The invention summarizes the basic structures, basic operation steps, methods and the like of biological ring implantation, mitral valve shearing, mitral valve prosthesis supports, valves and the like, and the rail-type mitral valve prosthesis implantation system and the operation method thereof save operation time and ensure that the operation can be completed safely and efficiently.

The embodiment of the invention provides an annuloplasty system and a biological ring implantation system capable of fixing a mitral valve prosthesis support, aiming at the problems that after the mitral valve prosthesis is implanted, the fixation is unreliable, the sealing is not tight, the mitral valve support releases deformation to extrude a left ventricle outflow channel, and obstruction is easily caused, so that the implantation effect is influenced, and the like. The annuloplasty system provides preparation for the next step of bio-ring placement and mitral valve cutting. The looping system can comprise a capture magnetic ball, a magnetic ball to be captured, two deformable conveying wires, a deformable conveying wire outer sleeve, a control guide pipe system thereof and the like. The deformable delivery wire is made of a memory metal (e.g., nitinol) that deforms between a low temperature shape and a high temperature shape in response to temperature, i.e., changes shape when blood temperature is sensed within a blood vessel. The catching magnetic ball is positioned at the top of the second deformable wire conveying pipe, the magnetic ball to be caught is positioned at the top of the first deformable wire conveying pipe, and the corresponding deformable wire conveying pipe is wrapped inside the outer sleeve of the deformable wire conveying pipe to play a supporting role. Under the action of the external catheter system, the catching magnetic ball can gradually extend out of the deformable conveying screw sleeve to catch and fix the magnetic ball to be caught to form a catching buckle. And under the stretching action of the external catheter system, the catching button enters the deformable conveying wire outer sleeve and is stretched out of the human body. The system may form an annulus of a first deformable delivery wire around the mitral annulus.

The embodiment of the invention provides a mitral valve cutting system, aiming at the problems that after a mitral valve prosthesis is implanted, original mitral valve leaflets can be propped by a support, an anterior valve with a large surface area can be wrapped on the support, and a left ventricular outflow tract is obstructed because the anterior valve with the large surface area blocks partial blood flow. The mitral valve cutting system can include a cutting head, connecting tubes, adjusting conduits, etc. (if the cutting medium utilizes a laser, such as a holmium laser, the cutting depth can be 4mm, preventing miscut of other tissues). At the moment, a catheter connected with the cutter head can be placed in the device, the angle range is adjusted, the position is found when the diseased mitral valve is closed and fixed, and the cutter head is utilized to be away from the position of the original diseased mitral valve of the human body, which is far away from the central axis of the valve ringToThe cutting of the anterior valve is performed at a location near the central axis of the mitral annulus. The cut original diseased mitral valve of the human body is expanded due to the expansion after being expanded by the ear-shaped anchoring element in the mitral valve prosthesis bracketJoint cuttingThe mitral valve prosthesis bracket has the advantages that the mitral valve and chordae tendineae which are originally diseased in a human body can not be wrapped on the periphery of the mitral valve prosthesis bracket, so that a blood flow channel created by the mitral valve prosthesis is smoother, the obstruction of a left ventricle outflow tract is inhibited, and the death rate is reduced.

In addition, embodiments of the present invention provide a bio-ring implant system, which may include a bio-ring made of a material having a good biocompatibility, and a diameter of the bio-ring may range from 4 cm to 6cm, wherein the bio-ring is formed by simultaneously extruding two ends of a delivery catheter system, and the two ends may have an internal thread and an external thread, respectively, and the external thread enters the internal thread to lock the bio-ring during the extrusion. After the mitral valve prosthesis stent is placed in the corresponding position, the size of the biological ring can be adjusted to a more proper diameter by the delivery catheter system, so that the mitral valve prosthesis can be more reliably fixed and sealed.

The invention also provides a mitral valve prosthesis bracket, a valve and an implanting method, wherein the shape of the upper part of the bracket can be similar to a lotus shape, and the bracket can be tightly attached to the upper end of the mitral valve in the left atrium when being opened, so as to prevent the impact of blood flow. In order to prevent the lotus layer from extruding the aorta when the stent is released and opened, the front leaflet part of the lotus layer is arranged and is superposed with the front leaflet position of the original mitral valve of a human body. The stent can be provided with a middle concave layer, the diameter range is also 4-6 mm, and the diameter of the middle concave layer is matched with that of the biological ring in the ring placing system. The bio-ring enters this middle concave layer and snaps when the stent is released open. Due to the clamping and fixing effect of the biological ring on the mitral valve prosthesis, the mitral valve prosthesis cannot fall off along with the beating of the heart or the influence of blood flow, or the mitral valve prosthesis cannot extrude the outflow tract of the left ventricle to cause obstruction. In addition, the lower end of the bracket can be slightly wider than the waist groove, when the bracket is opened, the cut original diseased mitral valve of a human body can be spread, and a smooth blood flow channel is formed from the position of the original diseased mitral valve of the human body to the position of the aortic valve. In addition, radiopaque alignment elements are provided to align the mitral valve stent with the native diseased mitral valve anatomy of the human body when the mitral valve stent is implanted. In order to open and fix the slit of the original diseased mitral valve of the human body cut by the cutting system when the mitral valve prosthesis stent is released, a left ear anchoring piece and a right ear anchoring piece are arranged, the angle of the ear anchoring pieces extends outwards in the radial direction, and the ear anchoring pieces point to the upstream left atrium end of the original diseased mitral valve of the human body when the stent is observed from the upper part, and the ear anchoring pieces are provided with a plurality of thorns, so that the original diseased mitral valve of the human body is fixed more stably.

The mitral valve prosthesis stent comprises a mitral valve prosthesis stent and a mitral valve prosthesis implantation method. In both of the above delivery systems, wherein the transseptal delivery method, the lower end of the prosthetic stent may be released first in the left ventricular portion (i.e., the mitral valve prosthetic stent support layer), i.e., fine-tuned to move up, to position the concave layer in the middle of the mitral valve prosthetic stent as far as possible in the root of the native diseased mitral valve of the human body, and then the left atrial prosthetic portion (i.e., the lotus layer on top of the mitral valve prosthetic stent) may be released.

Drawings

In the drawings, like reference characters designate like parts throughout the different views, and highlight the principles of the invention. The details of the drawings are simplified, such as the simplified omission of the mitral chordae tendineae.

FIG. 1 shows the working state of a magnetic ball to be captured, the magnetic ball to be captured and the connection of the magnetic ball to a transmission wire in a looping system;

fig. 2 shows a process flow of annuloplasty of the annuloplasty system (wherein, fig. 2a shows a correct to-be-operated position of the annuloplasty system on an original diseased mitral valve of a human body, fig. 2b shows that the to-be-captured magnetic ball and the captured magnetic ball attract each other to form a capture button when the annuloplasty system is in the correct position of the mitral valve, fig. 2c shows that the capture button is pulled out of the mitral annulus by the second deformable delivery wire after the annuloplasty system forms the capture button in the mitral valve, fig. 2d shows that the outer sheath of the deformable delivery wire is withdrawn out of the mitral annulus after the annuloplasty system completes the annuloplasty, fig. 2e shows that the catheter system of the annuloplasty system is withdrawn from the human body after the annuloplasty system completes the annuloplasty, and the mitral annulus forms an annular shape formed by the first deformable delivery wire, which is ready for the next operation step);

fig. 3 shows a related diagram of the operation of the cutter (fig. 3a shows a diagram of the structure of the cutter, fig. 3b shows an initial state of the cutter in the embodiment, fig. 3c shows a final state of the cutter in the embodiment, and fig. 3d shows that the original mitral valve of a human body has a slit after the mitral valve is cut by the cutter);

fig. 4 shows a related diagram of a bio-ring (fig. 4a shows a structural diagram of a bio-ring to be placed in a mitral valve annular space of a human body, fig. 4b shows a diagram of a locking buckle formed by an operating state of the bio-ring, fig. 4c shows a diagram of a 30 ° thread outside a locking tip and inside the locking ring, fig. 4d shows a state that the bio-ring enters the mitral valve annular space of the human body in the embodiment, and fig. 4e shows a diagram of an operating state that the bio-ring enters the mitral valve annular space of the human body in the embodiment);

fig. 5 shows a schematic view of a mitral valve prosthesis stent and valve in relation to each other (fig. 5a shows a schematic view of a mitral valve prosthesis stent and valve in structure, fig. 5b shows a schematic view of the mitral valve prosthesis stent and valve from the oblique top, in order to distinguish the morphology and position of the anterior leaflet of the top lotus layer of the mitral valve prosthesis stent and the opaque alignment element, fig. 5c shows a schematic view of the mitral valve prosthesis stent from the oblique top, in order to distinguish the position and structure of the auricular anchors of the mitral valve prosthesis stent, fig. 5d shows a schematic view of the mitral valve prosthesis stent alignment element and the auricular anchors in the mitral valve of a human body, in which the anchors hold open the incised slots of the native diseased mitral valve after release, fig. 5e shows the mitral valve prosthesis stent and valve in the position of the mitral valve of the human body when released, in order to form a clear blood flow path);

fig. 6 illustrates a mitral valve prosthesis delivery method (fig. 6a illustrates a transapical mitral valve prosthesis delivery method, fig. 6b illustrates a transseptal mitral valve prosthesis delivery method);

fig. 7 shows that after the cutting of the original diseased mitral valve, the insertion of the biological ring, the insertion of the mitral valve prosthesis stent and the valve are completed, 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 to maintain the normal shape and function of the heart.

While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. The invention is not, however, limited to a particular embodiment, but is intended to cover all modifications and variations within the scope of the invention.

Detailed Description

The rail-type mitral valve prosthesis implanting system and the operating method are used for solving the problems of firm anchoring, reliable sealing, unobstructed outflow channel and the like when the mitral valve prosthesis is implanted. Embodiments disclosed herein relate to four subsystems, according to implementation steps and system functions: mitral annuloplasty devices (fig. 1-2), mitral valve cutting systems (fig. 3), bio-ring insertion systems (fig. 4), mitral valve prostheses (fig. 5), and mitral valve prosthesis delivery insertion methods (fig. 6).

First, the present application discloses a rail-mounted mitral valve implantation system, which includes:

mitral annuloplasty device: as shown in fig. 1, the mitral annuloplasty device includes a capturing magnetomechanical ball 101, a to-be-captured magnetomechanical ball 104, a first deformable delivery wire 103, and a second deformable delivery wire 105. The capture magnetic ball 101 and the magnetic ball 104 to be captured have magnetic forces, and the magnetic forces are opposite poles. The catching magnetic ball 101 is fixedly connected with the end of the second deformable transmission wire 105, the magnetic ball 104 to be caught is positioned at the top end of the first deformable transmission wire 103, and the magnetic ball 104 to be caught depends on magnetic force to catch the magnetic ball 101 and then attract and fix to form a catching buckle joint 101(104) (called a "catching buckle" for short) so as to form a ring-shaped body structure. After the capture buckle connector 101(104) is formed, the capture buckle connector is pulled by the second deformable delivery wire 105 into the outer sheath 106 of the deformable delivery wire and out of the body through the catheter system. The first deformable delivery wire 103 forms a guidable channel in the shape of an annulus surrounding the base of the native mitral valve leaflets, the diameter of the annulus being adjustable. In practice, the annular body is delivered by the first deformable delivery wire 103 and the catheter system to the respective working position, i.e. the position of the base of the native mitral valve leaflet.

Mitral valve shearing system: the device mainly comprises a laser cutter 200 and a mitral valve closure adjusting guide pipe 208, wherein the laser cutter 200 comprises a laser conducting optical fiber 201, a conversion connector 202, an angle adjusting short section 203, a connector 204, a cutter head 205, holmium laser 206 (about 4mm) and an angle adjusting line 207. The laser conducting optical fiber 201 is connected with the angle adjusting short section 203 through the conversion connecting joint 202, the angle adjusting short section 203 is connected with the cutter head 205 through the connector 204, all the connections are threaded, and sealing can be achieved. The two ends of the angle adjusting line 207 are fixedly connected with the outer walls of the conversion connector 202 and the connector 204 respectively so as to realize the angle adjustment of the blade.

In some embodiments, the laser cutter can be replaced by a sharp micro cutter, the laser conducting optical fiber 201 in the laser cutter is replaced by a connecting pipe, and a blade is arranged below the cutter head to form the micro cutter.

The laser cutter or sharp micro-cutter 200 may have two shearing cutting media, if laser cutting is used, such as holmium laser wavelength of 2.1 μm, just above the absorption peak of water. Due to the shielding effect of water, the penetration depth of holmium laser in the tissue is less than 0.4mm, so that accurate and safe cutting can be performed on the surface of the tissue, and mistaken cutting, perforation and the like can not occur. The laser transmission optical fiber 201 is transmitted by quartz crystal, and a firm and wear-resistant coating layer is arranged outside the laser transmission optical fiber to protect the optical fiber from being damaged and broken in the using process; if the mitral valve is cut with a cutter, the cutter should be sharp enough to cut the mitral valve quickly.

In actual operation, the anterior valve is cut by a laser cutter or a cutting knife from a position far away from the central axis of the mitral valve annulus to a position close to the central axis of the mitral valve annulus, so that the mitral valve slit is obtained.

Biological ring implantation system: comprising a bio-ring 300, as shown in fig. 4, the bio-ring 300 comprises a bio-ring locking tip 301, a bio-ring locking ring 304, a first bio-ring 302 (on the side of the bio-ring locking tip) and a second bio-ring 303 on the side of the bio-ring locking ring), wherein as shown in fig. 4a, the adjacent ends of the first bio-ring 302 and the second bio-ring 303 are integrally connected (integrally connected between the end of the first bio-ring 302 and the end of the second bio-ring 303 away from the bio-ring locking tip 301 and the bio-ring locking ring 304), the first bio-ring and the second bio-ring are essentially in the shape of an integral strip, and are respectively expressed as a first bio-ring and a second bio-ring for convenience of representation and illustration; a through hole for the first deformable wire 103 to pass through is formed in the inner part (i.e. the inner part of the biological ring in the length direction) of the biological ring 300, the front end part of the biological ring locking tip 301 is of a tip structure, the outer periphery of the rear end part is provided with an external thread, the rear end part of the biological ring locking tip 301 is fixedly connected with one end part of the first biological ring 302, one end of the biological ring locking ring 304 is fixedly connected with the end part of the second biological ring 303, the inner wall of the biological ring locking ring 304 is provided with an internal thread, and the internal thread is matched with the external thread of the rear end part of the biological ring locking tip; the internal thread and the external thread are both pagoda-shaped threads. The bio-ring locking tip 301 and the bio-ring locking ring 304 are used to lock under the push of the first bio-ring 302 and the second bio-ring 303 to form a bio-ring lock. The inner part of the biological ring is provided with a through hole for the first deformable wire 103 to pass through, and the biological ring is provided with a lead-in hole for leading in two ends of the first deformable wire, the lead-in hole is approximately positioned in the middle of the biological ring, and the lead-in hole is communicated with the through hole. 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 under the guidance of the annular body formed by the first deformable wire 103 to form a biological ring locking buckle, so as to form a biological ring with adjustable diameter for wrapping the root of the original mitral valve.

As shown in fig. 4c, the thread side of the external thread of the rear end of the bio-ring locking tip 301 is at 30 ° to the central axis thereof, and the thread side of the internal thread of the bio-ring locking tip 304 is at 30 ° to the central axis thereof, and the bio-ring locking tip 301 enters the interior of the bio-ring locking tip 304 under the guiding action of the tip at 30 ° of the top. Because the range of the outer wall of the biological ring locking tip 301 (namely the range of the rear end part thereof) is provided with a thread which forms an angle of 30 degrees with the central axis; the inner wall of the biological ring locking ring 304 is also provided with a thread tooth which forms an angle of 30 degrees with the central axis, the biological ring locking tip 301 and the thread tooth inside the biological ring locking ring 304 are matched with each other, and the function is that when the biological ring locking tip 301 advances, the biological ring locking tip can slide forwards along a step surface of 30 degrees; however, when the back of the screw thread is at 90 degrees to the central axis, the screw thread has a blocking function and cannot be pushed out backwards (similar to a common cable tie in daily life).

Mitral valve prosthesis stent and valve: and fixing the mitral valve prosthesis stent and the matched valve in the biological ring.

Wherein the mitral valve prosthesis stent 400 is anchored together in conjunction with a mitral valve prosthesis valve 404 to perform a mitral valve prosthesis function. The mitral valve prosthesis stent 400 may be made of a memory alloy (e.g., nitinol) by laser cutting, photochemical etching, or the like, and may recover a corresponding shape when released after reaching a corresponding position.

As shown in fig. 5a, the mitral valve prosthesis stent, which is a radially self-expanding tubular body, 400 comprises a stent top lotus layer 401, a stent middle recessed layer 402, a stent bottom support layer 403, a left fibrous trigone alignment element 406, a right fibrous trigone alignment element 405, a left ear anchor 407, a right ear anchor 408, and a top lotus layer anterior leaflet 409. The main body of the mitral valve prosthesis stent consists of a stent top lotus layer 401, a stent middle concave layer 402 and a stent bottom supporting layer 403 which are communicated with each other.

As shown in fig. 5a, the stent top lotus layer 401, the stent middle concave layer 402 and the stent bottom support layer 403 are communicated to form a tubular body, the stent top lotus layer 401 is formed by connecting a plurality of filaments similar to lotus petals to form an annular flange, the front end of the stent top lotus layer 401 is provided with the top lotus layer front leaflet 409, wherein the top lotus layer front leaflet 409 is formed by three lotus-like filaments, and the lotus-like filaments of the top lotus layer front leaflet 409 are different from other filaments (such as the filaments forming the stent top lotus layer 401): the angle of the filaments of the anterior leaflet portion 409 of the top lotus layer to the central axis of the mitral valve prosthesis stent 400 is different from the angles of the other filaments (e.g., the angle of the filaments of the anterior leaflet portion 409 of the top lotus layer to the prosthesis stent is 10 °, and the angle of the other filaments to the prosthesis is 45 °). For the reasons mentioned above, the shape of the flange formed by the lotus-like filaments is not a regular circle, is similar to the letter D, and can better conform to the anatomical structure of the original diseased mitral valve 210 of the human body.

A left fiber triangular area aligning element 406 and a right fiber triangular area aligning element 405 are respectively arranged on the bracket top lotus layer 401 on the left side and the right side of the small leaf part 409 in front of the top lotus layer, a nontransmissive processing area is arranged on the aligning elements so as to be convenient for observation under perspective development in the operation process, the position of the mitral valve prosthesis bracket 400 is calibrated, the left fiber triangular area aligning element 406 is located close to the left fiber triangular area, and the right fiber triangular area aligning element 405 is located close to the right fiber triangular area, so that accurate release is realized. The correct position of the stent top lotus layer 401 in the heart is: the natural mitral valve position is near a portion of the inner wall of the left atrium.

The stent middle recessed layer 402 is formed by connecting triangular filaments and is characterized in that a flange diameter is formed to be smaller than the diameter of the stent top lotus layer 401, so that a recessed ring groove is formed for enabling a biological ring to enter the recessed ring groove and be fixed. The correct position of the stent mid-concave 402 in the heart is: there is a biological ring location in the native mitral annulus.

The stent bottom support layer 403 is formed of triangular shaped filaments joined together and characterized by a flange diameter that is larger than the diameter of the stent middle recessed layer 402. Left and right auricular anchors 407 and 408 are provided on the stent bottom support layer 403 at positions corresponding to the anterior leaflet portion 409 of the top lotus layer, and the auricular anchor pieces (i.e., the left and right auricular anchors 407 and 408) are tabs extending radially outward from the mitral valve prosthesis stent and are oriented to be inclined upward toward the atrial portion. The correct position of the stent bottom support layer 403 in the heart is: the natural mitral valve location is near a portion of the inner wall of the left ventricle.

The lotus layer 401 at the top of the bracket, the concave layer 402 at the middle of the bracket and the supporting layer 403 at the bottom of the bracket are connected and supported by the columnar filaments.

As shown in fig. 5b (when the mitral valve prosthesis stent 400 is viewed from the oblique top), the three angles of the lotus-like filaments of the anterior leaflet portion 409 of the top lotus layer of the mitral valve prosthesis stent 400 are different from the angles of the other lotus-like filaments to form a D-shape, and the left fibrous trigone alignment element 406 and the right fibrous trigone alignment element 405 are respectively disposed on the lotus-like filaments on the left and right sides of the anterior leaflet portion 409 of the top lotus layer, and the shape thereof may be a circular ring. The mitral valve prosthesis 404 is composed of three leaflets, which can be extracted from animals such as pigs, and is shown in a valve state (closed state) as viewed from an atrial direction toward a ventricular direction, and the three leaflets of the mitral valve prosthesis 404 have a closed state and an open state (not shown) as shown in the figure. In the opening state, the three leaflets are pushed to contract by blood flow to form a blood flow channel, so that the blood flow can smoothly flow into the ventricles from the atria; in the closed state, the lower ends of the three-valve leaflets are squeezed by filling due to the action of the reverse blood flow, so that the blood flow passage in the middle of the tricuspid valve prosthesis is closed, and the reverse blood flow is prevented from flowing through the three-valve leaflets. Once implanted in the body, the prosthetic valve can either replace the native diseased mitral valve 210 of the body, thereby reducing or eliminating valve insufficiency. The mitral prosthetic valve 404 is free of valve cover at the native diseased mitral valve slit 209 of the body as described above so that blood can flow through it smoothly.

As shown in fig. 5c, when the mitral valve prosthesis stent 400 is viewed from the oblique top, the mitral valve prosthesis stent 400 is provided with a left auricle anchor 407 and a right auricle anchor 408, the angle of the auricle anchor is radially outward, the auricle anchor is viewed from the upper portion of the stent, the auricle anchor points to the upstream left atrium direction of the original diseased mitral valve 210 of the human body, and the left/right auricle anchors are provided with a plurality of thorns (the number of the thorns of the auricle anchor is 8 as shown in the figure), which is set in such a way that when the mitral valve prosthesis stent 400 is opened, the left auricle anchor 407 and the right auricle anchor 408 respectively support and open the slit on the original diseased mitral valve 210 of the human body, so that the original diseased mitral valve 210 of the human body and the related chordae tendineae are more snugly and firmly distributed on the auricle anchors. The blood flow channel formed by the mitral valve fissure 209 of the original lesion of the human body, which is created by the method, is not closed due to blood flow impact and the like.

As shown in fig. 5c, the mitral valve prosthesis stent 400 and the mitral valve prosthesis valve 404 are connected together 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 is shown at the stent bottom support layer 403), and a plurality of suture points are distributed on the prosthesis valve suture support strip 410, and the suture points allow the valve prosthesis (such as pericardium) to be jointed thereto. In this embodiment, the prosthetic valve is a tricuspid valve, and thus it includes three prosthetic valve suture support bars 410.

As shown in fig. 5d, when the mitral valve prosthesis stent 400 is placed in the correct position, the left fibrous trigone alignment element 406 and the right fibrous trigone alignment element 405 of the mitral valve prosthesis stent 400 are respectively placed at the left end and the right end of the original diseased mitral valve slit 209 of the human body, so that the original mitral valve slit is in the center position as much as possible, and 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. The left ear anchor 407 (right ear anchor 408) gradually extends into the body's original lesion mitral valve slit 209 after the mitral valve prosthesis stent 400 is released and opened, and the left ear anchor 407 and the right ear anchor 408 gradually extend and expand, respectively, as time goes by, to gradually expand and expand the body's original lesion mitral valve slit 209.

As shown in fig. 5e, after the mitral valve prosthesis support 400 and the mitral valve prosthesis valve 404 are implanted, the mitral valve position in the heart is determined, the left fibrous trigone alignment element 406 and the right fibrous trigone alignment element 405 of the mitral valve prosthesis support 400 are respectively located in the left fibrous trigone and the right fibrous trigone of the original diseased mitral valve 210 of the human body, and the top lotus layer anterior leaflet 409 is located in the range between the left fibrous trigone and the right fibrous trigone, so that the tissue near the aorta is not pressed due to the gentle angle, and the blood flow passage can be kept open, thereby maintaining the normal structural configuration and the blood pumping function of each part of the heart (the aortic valve 501, the left ventricle 503, the right ventricle 506, the aorta 507, and the like).

In a second aspect, according to the above system, the present application provides an operating method of the above system, specifically including the following steps: the method comprises the following steps:

the first step is as follows: ring making: the annuloplasty is completed by a mitral annular space annuloplasty device,

as shown in fig. 2a-e, the positioning support tip 107 is delivered to a designated position in the ventricle by an external catheter delivery system, and the positioning support tip 107 and the outer sleeve 106 of the deformable delivery wire, the first deformable delivery wire 103, the second deformable delivery wire 105, etc. 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 realizing a series of operations outside the human body, such as delivering, transporting, positioning, etc., and all the actions realized in the heart in the present invention are completed through the operation of the external catheter delivery system) to perform positioning support function for the next ring-making work. The outer sheath 106 is fed by the catheter delivery system into the mitral annulus of the human body in the ventricle, and the trapping trackball 101, the to-be-trapped trackball 104, and the second 105 and first 103 deformable wires are pushed out.

As the human body continues to advance in the mitral annulus, the second deformable wire 105, the first deformable wire 103, and other components made of memory alloy materials sense the temperature change caused by blood, and gradually change into an extended state. The catch magnetic ball 104 and the catch magnetic ball 101 attract each other to form a catch clasp joint 101 (104).

The catching clasp joint 101(104) enters the deformable wire outer sleeve 106 under the pulling of the first deformable wire 103 and the second deformable wire 105. The flexible wire outer sheath 106, the positioning support tip 107, is pulled out of the body by the external delivery catheter system. To this end, a ring body (annular body) surrounding the base of the original mitral valve leaflet is formed by the first deformable delivery wire 103 as shown in fig. 2e, and the ring body (i.e. annular body) passively adjusts the size of the annular perimeter due to the deformable nature of the first deformable delivery wire 103. (the main function of the positioning support tip 107 in the annuloplasty procedure is support, since all the lines are soft and require a supporting force during this procedure. after the formation of the catching clasp joint 101(104), it can be withdrawn, but the intermediate withdrawal affects the other lines in the catheter delivery system, so it is done until the final ring around the base of the original mitral valve leaflet is formed and all the lines are withdrawn together);

the second step is as follows: shearing: this is done by a mitral valve cutting system (transcatheter mitral valve cutting system), as shown in figure 3a,

the mitral valve closure adjustment catheter 208 is controlled by a catheter delivery system. After the annuloplasty device for mitral annulus annuloplasty completes the annuloplasty procedure, two ends of the first deformable delivery wire 103 are obtained outside the body, and the remaining portion (annulus) of the first deformable delivery wire 103 remains at the annular root of the original diseased mitral valve. At this time, outside the human body, the two ends of the first deformable delivery wire 103 are kneaded together into a strand, the strand of the metal soft wire composed of the two first deformable delivery wires 103 is threaded into the mitral valve closure adjustment catheter 208, then the mitral valve closure adjustment catheter 208 is gradually pushed into the vicinity of the original diseased mitral valve along the metal soft wire by the catheter delivery system outside the human body, and in the process of gradually pushing the mitral valve closure adjustment catheter 208, the mitral valve closure adjustment catheter 208 can deform the annular body formed in the above-mentioned annuloplasty step, which is surrounded by the first deformable delivery wire 103 around the valve annulus root (i.e., the mitral valve leaflet root), even if the circumferential length of the annular body is reduced, and further shrink the annular body to compress the closure of the original diseased mitral valve 210 of the human body, so as to prepare for cutting the diseased mitral valve.

The closed mitral valve as described above is evenly distributed across the cross-section of the atrioventricular passageway, facilitating the location of the cut by the laser cutter or the sharp micro-cutter 200. The angle adjustment short section 203 of the laser cutter or sharp micro cutter 200 is made of deformable material and is adjusted in angle by the angle adjustment line 207 so that the cutting head 205 is aligned with different positions of the mitral valve to perform cutting.

As shown in fig. 3b-c, the laser cutter or the sharp micro-cutter 200 is operated in an initial state to cut the original diseased mitral valve by aligning the cutting head 205 with the major diameter of the original diseased mitral valve, and the laser cutter or the sharp micro-cutter 200 is operated by the angle adjustment line 207, so that the cutting head 205 gradually moves towards the center of the atrioventricular passageway (the cutting head moves away from the central axis of the annulus from the original diseased mitral valve of the human body)ToAn anterior valve cut is made near the central axis of the mitral annulus). A mitral slit 209 is formed under the trajectory of the movement of the cutting head 205. After the cutting operation is completed, the mitral valve closure adjustment catheter 208 is withdrawn to the outside of the body. To this end, the annular body formed by the first deformable delivery wire 103 recovers its shape, forming a mitral valve slit 209;

the third step: biological ring placement: 4a-b, specifically, a first biological ring 302 and a second biological ring 303 are arranged in the catheter of the external catheter system, and the biological ring locking tip 301 and the biological ring locking ring 304 are gradually closed under the pushing action of the external catheter system. After closing, 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 continuously squeezed, and the bio-ring locking tip 301 enters the interior of the bio-ring locking ring 304 and is locked, so as to form a bio-ring locking buckle 301(304), as shown in fig. 4 b.

As shown in fig. 4d-e, under the guiding action of the first deformable delivery wire 103, the tip 301 and the ring 304 enter the annular space of the mitral valve 100 and meet with each other under the action of external pushing force, and under the continuous action of the applied pressure, the tip 301 enters the inner locking teeth of the ring 304, and is locked to form a ring 301 (304). To this end, the bio-ring 300 is placed in the annular space of the mitral valve 100 (surrounding the base of the original mitral valve leaflets as illustrated in fig. 4 e);

the fourth step: mitral valve prosthesis and delivery placement:

there are two possible delivery and release methods for mitral valve prosthesis stent 400 and mitral valve prosthesis valve 404: transapical 508 delivery methods and transseptal delivery methods.

Referring to fig. 6a, which illustrates a method of transapical delivery of a mitral valve prosthesis holder 400 and a mitral valve prosthesis valve 404, a delivery device and system 604 with a mitral valve prosthesis holder and valve 603 compressed into a contracted state is introduced into the heart via the apex 508, against the chordae tendineae 504 and papillary muscles 505, and through the left ventricle 503 into the left atrium 502, under the influence of a delivery head 601 and a guidewire 602. The delivery system is manipulated to first expose the left fibrous trigone alignment element 406, the right fibrous trigone alignment element 405, and the top lotus layer anterior leaflet portion 409 of the stent top lotus layer 401 on the mitral valve prosthesis stent 400. Under observation by the transillumination visualization technique, the physician can observe the light-opaque alignment elements, i.e., the left fiber trigonal alignment element 406, the right fiber trigonal alignment element 405, and adjust the alignment of the alignment elements by rotating the delivery device and system 604.

After alignment is adjusted, the delivery device and system 604 continues to be retracted, further exposing the mitral valve prosthesis stent 400, allowing the radial constraint of the stent top lotus layer 401 to be completely removed, allowing more self-expansion of the stent top lotus layer 401 to form a flange, snug against the atrial surface. Continuing to expose the stent central recess 402, allowing for more outward expansion of the mitral prosthetic valve 404, the stent central recess 402 expands into engagement with the mitral annulus and the now unexpanded ear anchors gradually enter the native diseased mitral valve slit 209 of the body in preparation for the next step of capturing and supporting tissue on either side of the slit. If not aligned, the delivery system may be slightly adjusted to allow the unexpanded left and right ear anchors 407, 408 to enter the native diseased mitral valve slit 209 of the human body. At this point, the stent is recessed within the layer 402 just outside the bio-ring 300.

After the human mitral valve is fixed under the action of the biological ring 300 and the stent middle concave layer 402, the stent is pulled towards the atrium by an external catheter system, so that the biological ring 300 is located at the root position of the valve leaflets of the human mitral valve as far as possible, and at the moment, the catheter system controlling the size of the biological ring 300 is used for continuously pushing the biological ring locking tip 301 of the biological ring 300 to enter the inner locking teeth 304 of the biological ring locking ring, so that the biological ring 300 is more tightly surrounded the stent middle concave layer 402. Therefore, the human mitral valve is reliably fixed under the action of the bio-ring 300 and the concave layer 402 in the middle of the stent, and the stent cannot slide down due to blood flow and the like.

Further contraction of the delivery device and system 604 continues to release the stent bottom support layer 403, at which point the mitral valve prosthetic valve 404 expands outwardly into an expanded state, while at the same time the left and right ear anchors 407, 408 spread the native diseased mitral valve slit 209, capturing the native anterior leaflet and chordae tendineae 504 between the left and right ear anchors 407, 408 and the mitral valve prosthetic stent 400. After the delivery is complete, the delivery device and system 604 is withdrawn, removed from the heart from the apical incision, and the apical incision is ligated and sutured, etc.

As shown in fig. 6b, which illustrates a method of transseptally delivering mitral valve prosthesis holder 400 and mitral valve prosthesis 404, a delivery device and system 604 with mitral valve prosthesis holder 603 compressed into a contracted state is advanced from the vena cava into the right atrium 510 and continues to puncture the interatrial septum 509 (typically through the fossa ovalis) into the left atrium 502 under the influence of a delivery head 601 and a guide wire 602. The method and steps for releasing mitral valve prosthesis stent 400 and mitral valve prosthesis valve 404 are similar to the transapical delivery method and are not described in detail.

As shown in fig. 7, after the mitral annuloplasty device, the mitral valve cutting system, the bio-ring insertion system, the mitral valve prosthesis delivery insertion system, and other operation steps, a clear blood flow channel is formed between the left atrium and the left ventricle of the heart, and the mitral valve prosthesis does not fall off along with the heartbeat or the blood flow influence, so as to achieve and maintain the normal structural configuration of each part of the heart (such as the tissue near the aortic valve).

The above-mentioned embodiments are only preferred embodiments of the present invention, but should not be construed as limiting the scope of the invention. Therefore, the equivalent changes made in the claims of the patent of the present invention still belong to the scope covered by the patent of the present invention.

Claims

1. An orbital mitral valve prosthesis implantation system, comprising: comprises that

2. The system of claim 1, wherein: the first deformable wire conveying wire and the second deformable wire conveying wire are made of memory metal.

3. The system of claim 1, wherein: a through hole for the first/second deformable wire conveying and feeding to pass through is formed in the biological ring along the length direction of the biological ring; the both ends of biological ring are established respectively to biological ring lock point end and biological ring lock ring, biological ring lock point end has the external screw thread, and biological ring lock ring is inside to be seted up with the internal thread of external screw thread looks adaptation, and biological ring lock point end is used for getting into biological ring lock ring and forms biological ring lock is detained.

4. The system of claim 3, wherein: the front end part of the biological ring locking tip is of a tip structure, and the outer periphery of the rear end part of the biological ring locking tip is provided with the external thread; the thread side of the external thread of the biological ring locking tip forms a 30-degree angle with the central axis, and the thread side of the internal thread of the biological ring locking tip forms a 30-degree angle with the central axis.

5. The system of claim 1, wherein: the left/right ear-shaped anchoring parts are respectively provided with a plurality of thorn spines in the circumferential direction;

the left/right ear anchors are tabs extending radially outward from the mitral valve prosthesis stent and their orientation is set to be inclined upward.

6. The system of claim 5, wherein:

a top lotus layer front leaflet part is arranged at the front end part of a lotus layer at the top of the bracket, a left fiber triangular area aligning element and a right fiber triangular area aligning element are respectively arranged on the lotus layer at the top of the bracket at the left side and the right side of the lotus layer front leaflet part at the top, and a left/right ear-shaped anchoring part is arranged on a supporting layer at the bottom of the bracket corresponding to the position of the lotus layer front leaflet part at the top;

7. The system according to any one of claims 1-6, wherein: the system also comprises a valve matched with the mitral valve prosthesis bracket, the mitral valve prosthesis bracket is connected with the mitral valve prosthesis valve through a prosthesis valve sewing support bar, and the shape of the prosthesis valve sewing support bar is consistent with the external contour of the mitral valve prosthesis valve.

8. A mitral valve prosthesis stent, comprising: the stent is a radial self-expanding tubular body and comprises a stent top lotus layer, a stent middle concave layer and a stent bottom supporting layer which are communicated; and a left ear-shaped anchoring part and a right ear-shaped anchoring part are arranged on the supporting layer at the bottom of the bracket.

9. The mitral valve prosthesis stent of claim 8, wherein: the front end part of the lotus layer at the top of the bracket is provided with a front leaflet part of the lotus layer at the top, the lotus layer at the top of the bracket at the left side and the right side of the front leaflet part of the lotus layer at the top is respectively provided with a left fiber triangular area alignment element and a right fiber triangular area alignment element, and a supporting layer at the bottom of the bracket below the front leaflet part of the lotus layer at the top is provided with a left ear-shaped anchoring element and a right ear-shaped anchoring element; the left and right ear anchors are shown with a plurality of barbs disposed circumferentially on each.

10. A method of operating a system as claimed in any one of claims 1 to 7, characterized by: the method comprises the following steps:

step 1): creating a steerable pathway for the bio-ring: the deformable conveying wire outer sleeve and the mitral valve annular space annuloplasty device are placed in the mitral valve annular space by an external catheter conveying system, under the guidance of the deformable conveying wire outer sleeve, the second deformable conveying wire and the first deformable conveying wire are pushed in the mitral valve annular space, the capture magnetic ball and the magnetic ball to be captured are mutually attracted to form a capture buckle joint, and therefore the first deformable conveying wire forms a circular annular guide channel surrounding the root of the mitral valve leaflet;

step 2): the bio-ring is implanted to form an annular structure surrounding the mitral valve root: pushing the biological ring along the channel in the step 1) to lock two ends of the biological ring to form a biological ring locking buckle, so that the biological ring is placed in the annular space at the root of the mitral valve, and the biological ring surrounds the root of the mitral valve;