WO2020114299A1 - 支架瓣膜假体及其输送*** - Google Patents

支架瓣膜假体及其输送*** Download PDF

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Publication number
WO2020114299A1
WO2020114299A1 PCT/CN2019/121480 CN2019121480W WO2020114299A1 WO 2020114299 A1 WO2020114299 A1 WO 2020114299A1 CN 2019121480 W CN2019121480 W CN 2019121480W WO 2020114299 A1 WO2020114299 A1 WO 2020114299A1
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WO
WIPO (PCT)
Prior art keywords
valve
stent
sheath
clamping member
clamping
Prior art date
Application number
PCT/CN2019/121480
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English (en)
French (fr)
Inventor
吕世文
李毅斌
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宁波健世生物科技有限公司
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Publication of WO2020114299A1 publication Critical patent/WO2020114299A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol

Definitions

  • the present application belongs to the field of medical devices, and specifically relates to a stent-valve prosthesis and its delivery system.
  • the mitral valve structure consists of mitral annulus, anterior valve, posterior valve, chordae, papillary muscle, left atrium and left ventricle.
  • the anterior and posterior leaflets are jointly divided, located in the anterior lateral part and the posterior middle part, respectively.
  • the tendon cords from the bilateral papillary muscles are inserted into the valve leaflets. According to the different insertion sites, the tendon cords are divided into three categories: joint tendon, anterior lobe tendon, and posterior lobe tendon.
  • the joint tendon is inserted into the valve joint area as the name suggests.
  • the single tendon usually emitted by the papillary muscles, is fan-shaped bifurcated and inserted into the valve leaflet joint.
  • the anterior lobe tendon is inserted into the free edge of the anterior lobe to provide the necessary support for the anterior leaflet.
  • the posterior leaf tendon is inserted into the free edge and base of the posterior leaf at the same time.
  • Mitral valve disease is the most common valvular disease, mainly caused by pathological changes of the valve itself or secondary changes caused by pathological changes of the left heart system.
  • Statistics from 1994-2003 in the United States alone show that the number of mitral valve operations has doubled in the past decade.
  • the number of mitral valve replacements was as high as 65,000, and some patients underwent coronary artery bypass grafting at the same time.
  • mitral valve replacement surgery is the only way to extend their lives .
  • transcatheter replacement surgery has gradually become the mainstream surgical procedure for mitral valve replacement.
  • the replacement device be accurately positioned at the required location; how can the artificial valve carrier (usually the stent structure) be anchored firmly to the required The position of the replacement device; how the replacement device adapts to the differences in the physiological structure of the annulus.
  • the following is a list of technical points of different mitral valve replacement devices in the current traditional technology.
  • Patent CN103079498A describes a transcatheter mitral valve prosthesis, whose anchor has an atrial skirt, annulus and ventricular skirt, the ventricular skirt further includes a triangle placed on the front of the ventricular skirt Anchoring ears, the triangular anchoring ears are adapted to be anchored against the first fibrous triangular region on the first side of the anterior leaflet of the patient's mitral valve, so that the anterior leaflet and the adjacent tendon cord are captured in the triangle Between the anchor ear and the front surface of the anchor.
  • the ventricular skirt further includes a second triangular anchoring ear disposed on the front of the ventricular skirt, the second triangular anchoring ear is adapted to abut against the first fiber triangular region
  • the second fiber triangle area is anchored so that the anterior leaflet and the adjacent tendon cord are captured between the second triangle anchor ear and the front surface of the anchor.
  • the ventricular skirt further includes a posterior ventricular anchoring ear disposed on the rear of the ventricular skirt, and wherein the posterior ventricular anchoring ear is adapted to be anchored on the posterior leaflet of the patient's mitral valve, thereby The posterior ventricular anchor ear is seated between the posterior leaflet and the ventricular wall of the patient's heart.
  • the ventricular skirt is radially expanded so that the natural mitral valve leaflets are displaced radially outward, and the valve leaflets and adjacent tendon cords are clamped while radially expanding.
  • the problem with this design is that the release of the anchoring ears is irreversible, and it is difficult to ensure that the leaflets and their tendons can be clamped in one release; before the anchoring ears are released, the annular portion has been partially opened to compress the natural Valve leaf, at this time, a natural leaf leaf has failed and the artificial valve leaf fails to function, which affects the normal heart blood supply function of the patient; limited by the release position, release form, and tendon environment, anchor the ear piece It can only be coated and clamped from the area where the valve leaflets are relatively free of tendons, and its clamping stability is not ideal.
  • Edwards discloses a mitral valve replacement stent, which includes at least one clamping member on the outer surface of the stent.
  • the gap between the clamping member and the outer surface of the stent is used to capture the leaflets.
  • the gap between the clamping member and the outer surface of the stent becomes smaller and smaller, thereby clamping the leaflets therein.
  • the support force of the bracket When the support force of the bracket is too large, it will cause The normal work of compressing the tissues near the mitral valve, such as the aortic valve, is difficult for designers to balance the support force of the stent while pursuing a large clamping force of the clamping member; the second is that the process of turning and shaping the clamping member is complicated, even if it is shaping Success, the fatigue resistance of the clamping member is also to be discussed; the third is that the clamping member can only be coated and clamped from the region where the valve leaflet is relatively free of the tendon, and the clamping stability is not ideal; the fourth is the same clamp The holder can only hold a single leaflet, and the backflow between the leaflets cannot be avoided.
  • Patent US20080033541 discloses a method of fixing a mitral valve stent on a mitral valve annulus, which uses an expansion member fixed on the stent to interfere with most of the left atrium, thereby achieving an anchoring effect.
  • the problem with this design is that the artificial mitral valve is subject to a large upward and downward displacement during movement. If the stiffness of the expansion member is insufficient, it is difficult to play the role of anchoring; but if the The excessive rigidity of the spreader is easy to damage the atrial tissue.
  • Patent US20130053950 describes a mitral valve stent, which is connected to the ventricular part of the valve stent with a tension unit, one end of the tension unit is connected to the stent, the other end is connected to the myocardium, the tension unit is used to reduce the Stress caused by contraction of the ventricle.
  • the problem with this design is that unlike the mitral valve repair instrument, the replacement stent is subjected to a large impact when the heart contracts, and the pull unit alone cannot guarantee that it will not be washed away from the annulus, even if it is not The annulus will also shift the position of the replacement stent, resulting in a large amount of reflux.
  • Patent US20140005778 discloses a method of fixing a mitral valve stent on a mitral annulus, which introduces a valve stent fixing device, the valve stent fixing device is composed of two upper and lower clips, the clips are composed of At least two bridge units are connected.
  • the valve stent fixing device can be inserted into the sheath. After the sheath is removed, the mitral valve annulus is located between the upper and lower clips, and then the valve stent is transported to be expanded in the fixing device.
  • the problem with this design is that the structure of the mitral valve varies greatly between different patients, and it is difficult for suppliers to hold different patients with fixed devices of limited specifications; during the period of beating heart, the annulus tissue attached to the posterior mitral valve The size of the product varies greatly, which also makes the design difficult.
  • Patent US20140142691 discloses a method for fixing a mitral valve stent, which is provided with an auxiliary anchored stent on the aorta, and the auxiliary anchored stent is connected with the mitral valve stent to achieve a fixed mitral The purpose of the valve support.
  • the limitation of this design is that placing an auxiliary anchored stent in the aorta increases the difficulty of the operation and also brings the risk of damage to the aorta.
  • the connecting rod between the auxiliary anchored stent and the mitral valve stent will affect the normal function of the aortic valve and its associated tissues.
  • aortic valve stent and the mitral valve stent are placed at the same time, patients suitable for surgery will be very rare, even if there are such patients, the difficulty of surgery will be greatly increased. Moreover, there is a risk of mutual influence on each other. Once the placement position is deviated, or the position of the stent is deviated due to subsequent cardiac motion, it directly affects the life safety of the patient.
  • a clamping member is provided on the bracket, and the clamping member includes a side wing having a root parallel to the longitudinal axis of the bracket and capable of rotating around the root.
  • the side wing extends along the
  • the valve sewing segment is displaced in the radial direction, passes through the junction of the adjacent tissue valve leaflets of the patient to reach between the valve leaflets and the heart wall, and then rotates around the root and abuts against the outer surface of the valve sewing segment. After the release, the patient's tissue valve leaflets and adjacent tendon cords are clamped between the lateral wings and the valve sewing section, which is beneficial to improve the anchorage of the valve stent and greatly improve the success rate of the operation.
  • a stent-valve prosthesis includes a stent, a valve leaflet, and a clamping member.
  • the stent includes a support section and a valve sewing section. The proximal end of the support section is connected to the distal end of the valve sewing section.
  • the valve leaflets are connected to the sewed segment of the valve. After the support segment is released, it can be placed on the annulus of the patient and abut against atrial tissue.
  • the clamping member includes one or more flanks.
  • the clamping member One end is fixedly connected to the outer surface of the valve sewing section, and the clamping member has three forms in order from compression to full release, the first form is that the flanks are compressed in the control device; the second form is The flanks extend in the radial direction of the valve sewing segment and can pass through the leaflet junction of adjacent tissues to reach between the valve leaflets and the heart wall; the third form is that the flanks are along the perimeter of the valve sewing segment Stretching and abutting the outer surface of the sewed section of the valve.
  • the side wing has a root, and the clamping member is fixedly connected to the outer surface of the valve sewing section through the root.
  • the side wings can rotate around the root.
  • the root is parallel to the longitudinal axis of the stent.
  • the root is provided on the distal portion of the valve sewing section.
  • the root is fixed at the junction of the valve sewing section and the support section.
  • the flanks are arc-shaped structures, and the flanks expand circumferentially along the outer surface of the sewed section of the valve in a natural state. After the flanks are released, the tissue leaflets and adjacent tendons of the patient are clamped between the flanks and the sewed segment of the valve.
  • the root when the clamp is released, the root is located at the junction of adjacent tissue leaflets of the target affected area. In one of the embodiments, when the clamp is released, the root is located at the junction of the anterior and posterior mitral valves of the patient, or the root is located at the junction of the anterior and tricuspid valves of the patient The location, or the root is located at the junction of the anterior and posterior valves of the patient's tricuspid valve, or the root is located at the boundary of the posterior and septal valves of the patient's tricuspid valve.
  • the flanks are released before the valve sewing section is released.
  • the advantage of this design is that, while positioning through the flanks, it prevents the valve sewing section from being partially opened and compressing the natural valve leaflets. There was a time when the function of the natural valve leaflet had failed and the artificial valve leaflet failed, which affected the normal blood supply of the heart.
  • the ends of both sides of the clamping member are curved, and the flanks are arranged symmetrically, wherein each of the flanks has a single Or multiple continuous arc configurations.
  • the advantage of this design is that the use of curved ends can avoid puncturing the heart wall tissue to cause bleeding.
  • a convex point is provided on the clamping member to facilitate insertion into the sheath.
  • the side wings on both sides of the root of the clamping member are connected in a free state to form a closed-loop structure.
  • the flanks located on both sides of the root of the clamping member are connected to each other by clamping, welding, stitching, etc. in a free state, or are located on both sides of the root of the clamping member
  • the flanks are an integral structure wound by a shape memory alloy wire, or the flanks located on both sides of the root of the clamping member are integrally cut from a shape memory alloy tube.
  • the side wings on both sides of the root of the clamping member have an open-loop structure in a free state.
  • the side wing when the same clamping member includes only a single side wing, the side wing has a single or multiple continuous arc-shaped configurations, and one end of the clamping member is arc-shaped, The lengths of the flanks in the different clamping members spread along the outer surface of the valve sewing section in the free state are not equal.
  • the root portion is fixedly connected to the valve sewing section by means of gluing, welding, winding, clamping and the like.
  • a hole is provided in the distal portion of the sewed section of the valve, and the root is wound through the hole.
  • a gap is provided on the distal portion of the valve sewing section, and the root rides on the gap and passes through the hole.
  • a gap is provided on the distal portion of the valve sewing section, and the root rides on the gap and sleeves the jacket on the outer surface of the gap.
  • the outer surface of the jacket is provided with a slit, and the slit width is adapted to the diameter of the root.
  • the clamping member is formed by winding a shape memory alloy wire, or the clamping member is formed by cutting and shaping a shape memory alloy tube.
  • the diameter of the support section is larger than the diameter of the sewed section of the valve, and the support section is splayed outward along its axis into an inverted cone shape with a cone angle of 60-160°. In one of the embodiments, the cone angle is 135°.
  • the outer surface of the valve sewing section is partially covered, or the outer surface of the support section is partially covered, or both are partially covered.
  • the material of the membrane includes poly Tetrafluoroethylene, polyethylene, polypropylene, polyurethane, silicone, etc., to effectively prevent paravalvular leakage.
  • the leaflets are made of animal tissue or high molecular polymer.
  • the animal tissue is pig pericardium, bovine pericardium, horse pericardium, etc.
  • the high molecular polymer is polytetrafluoroethylene, polyurethane, or silica gel.
  • the stent is a self-expanding stent, and the material is a shape memory material or an elastic material.
  • the material of the bracket is nickel-titanium shape memory alloy.
  • the bracket is formed by integrally engraving a tube of shape memory material.
  • the bracket is made by integrally carving a nickel-titanium shape memory alloy tube.
  • a delivery system for a stent-valve prosthesis includes a stent-valve prosthesis, an outer sheath, a stent sheath, a stent sheath core, and a clamp sheath
  • the stent-valve prosthesis includes a stent, a valve leaflet, and a clamp
  • the stent includes a supporting section and a valve sewing section
  • the stent sheath and the clamping member sheath are disposed in the outer sheath
  • the clamping member sheath is located outside the stent sheath
  • the compression section is located in the distal portion of the stent sheath after compression
  • the compression section is located in the distal portion of the outer sheath after compression
  • the distal end is connected, the stent sheath core is arranged in the stent sheath, the clamping member is located in
  • the cross section of the holder sheath is non-circular.
  • a clamping member sheath core is further provided in the clamping member sheath, both the distal end of the clamping member sheath and the distal end of the clamping member sheath core are flexible, The distal end of the clamping member sheath core is in contact with the clamping member, and the proximal end of the clamping member sheath core is fixedly connected to the clamping member sheath core operating member.
  • the clamping member when the clamping member needs to be compressed into the clamping member sheath, the clamping member is straightened and compressed in the clamping member sheath in a direction opposite to the deployment direction.
  • the delivery system further includes a guide wire for the clamping member, the guide wire for the clamping member is located in the sheath core of the clamping member, and the side wing is opposite to the deployment direction along the root The direction is compressed to form a gap.
  • the clamping member is in the first form, the distal end of the guide wire of the clamping member passes through the gap, and the proximal end of the guide wire of the clamping member is fixed Connected to the guide wire operating part of the clamping part.
  • the distal portion of the holder sheath is provided with a slit.
  • rotating the gripper sheath operating member can rotate the gripper sheath together with the side wings located therein around the root.
  • the original valve leaflets will not work immediately.
  • the flanks pass from the junction of the patient's adjacent tissue leaflets to the leaflet and the heart wall Rotate around the root at the same time, and release from this position can avoid affecting the movement of the original mitral valve leaflet, maintain normal blood supply to the heart, and have more positioning time, which is conducive to doctors to adjust the position and improve the accuracy of positioning.
  • the flanks of the present application are released before the valve sewing section is released.
  • the advantage of this design is that, while positioning through the flanks, it prevents the valve sewing section from partially opening and pressing the natural valve leaflets, resulting in a
  • the failure time of the valve leaflets when the natural valve leaflets have failed and the artificial valve leaflets fail to work will affect the normal heart blood supply function of the patients.
  • the clamping piece and the valve sewing section in this application are designed separately and then connected together, and the side wings can rotate around the root , which can facilitate the side wing to realize the function of clamping the leaflet and its adjacent tendon, the designer can balance the support force of the stent, and can pursue the clamping piece to have a larger clamping force; and the shape of the clamping piece
  • the process is relatively simple and the fatigue performance is good.
  • the flanks in this application are arc-shaped structures.
  • the design of the arc-shaped structure allows the flanks to cling to the outer surface of the sewed section of the valve, and the flanks can simultaneously hold the leaflets and tendon cords.
  • the insertion of the lateral wings in the gap between the tendon cords also enhances the clamping effect.
  • the root of the present application is fixed at the junction of the valve sewing section and the support section. Such a design enables the root to be closer to the junction of the adjacent tissue valve leaflets of the patient during the release process.
  • the distal end of the gripper sheath and the distal end of the gripper sheath core of this application are both flexible, the purpose of which is to enable the gripper sheath and the gripper sheath core to conform to the Deformation of clamping parts.
  • the clamping piece sheath and the clamping piece sheath core are integrally pushed so that the clamping piece exposed part arches in the direction of the ventricular wall, and the side wings Passing from the junction of the patient's adjacent tissue valve leaflets to reach between the valve leaflets and the heart wall; at the same time this process is reversible, pulling the clamping member sheath and the clamping member sheath core integrally can expose the clamping member Partially restored to the non-arched state, so that the doctor can adjust the positioning multiple times and improve the positioning accuracy.
  • the guide wire of the clip is located in the sheath core of the clip, the side wings are compressed in the direction opposite to the direction of deployment along the root to form a gap, and the guide wire of the clip
  • this design can ensure that the side wing can only be fully opened when the clamping member guide wire is pulled out of the gap, avoiding the side wing from the clip
  • the release of the holder sheath prematurely spreads along the outer surface of the sewed segment of the valve to ensure that the tissue leaflet and the adjacent tendon of the patient are clamped between the flank and the sewed segment of the valve after the release is completed.
  • FIGS. 1a and 1b show schematic diagrams of the structure of the mitral valve
  • FIGS. 1c and 1d show schematic diagrams of the conventional technique of the mitral valve holder.
  • Figures 2a to 2d show schematic views of one embodiment of a stent-valve prosthesis of the present application.
  • 3a and 3b show schematic views of another embodiment of the stent-valve prosthesis of the present application.
  • 5a to 5d show schematic views of various embodiments of the stent-valve prosthesis of the present application.
  • 6a to 6h are schematic diagrams showing various connection modes between the clamping member and the valve sewing section of the present application.
  • FIG. 7a to 7f show schematic diagrams of various embodiments of the clamp of the present application.
  • FIG. 8a to 8e show schematic views of an embodiment of a delivery system of a stent-valve prosthesis according to an embodiment of the present application.
  • FIGS. 9a to 9e show schematic diagrams of another embodiment of a delivery system of a stent-valve prosthesis according to an embodiment of the present application.
  • 10a to 15c show step by step an operation process of the stent-valve prosthesis according to an embodiment of the present application.
  • 16a and 16b show a schematic diagram of a stent-valve prosthesis according to another embodiment of the present application.
  • 17a to 17d show another embodiment of a delivery system of a stent-valve prosthesis according to an embodiment of the present application.
  • 18a to 23c show another operation process of the stent-valve prosthesis according to an embodiment of the present application.
  • FIGS. 24a and 24b show schematic diagrams of a tricuspid valve structure
  • FIGS. 24c and 24d show schematic diagrams of a stent-valve prosthesis according to an embodiment of the present application when applied to the tricuspid valve field.
  • the distal end mentioned in this application refers to the end far from the apex of the heart, and the proximal end refers to the end close to the apex of the heart.
  • the mitral valve structure 010 is shown in FIGS. 1a and 1b.
  • the mitral valve structure 010 is composed of a mitral valve annulus 011, an anterior valve 012, a posterior valve 013, a tendon 014, a papillary muscle 015, a left atrium 016, and a left ventricle 017.
  • the anterior valve leaflet 012 (A1, A2, A3) and the posterior valve leaflet 013 (P1, P2, P3) are jointly segmented, located in the anterior lateral part and the posterior middle part, respectively.
  • a stent-valve prosthesis 100 including a stent 110, a leaflet (not shown), and a clamping member 130.
  • the stent 110 includes A support section 111 and a valve sewing section 112, the proximal end of the support section 111 is connected to the distal end of the valve sewing section 112, the valve leaflet is connected to the valve sewing section 112, the support After the segment 111 is released, it is placed above the annulus of the patient and abuts against atrial tissue.
  • the stent-valve prosthesis 100 includes two of the clamping members 130.
  • Each clamping member 130 includes a single or two side wings 131 having a root 132 parallel to the longitudinal axis of the bracket 110 and capable of rotating around the root 132, one end of the clamping member 130 passing through The root portion 132 is fixedly connected to the outer surface of the distal end portion of the valve sewing section 112, and the clamping member 130 has three forms in sequence from compression to full release.
  • the first form is that the flanks 131 are compressed under control In the device;
  • the second form is that the lateral wings 131 extend in the radial direction of the valve sewing section 112, passing through the patient's adjacent tissue leaflet junction to reach between the leaflet and the heart wall;
  • the third form is the The lateral wings 131 extend circumferentially along the valve sewing section 112 and abut against the outer surface of the valve sewing section 112.
  • the flanks 131 are displaced in the radial direction of the sewed segment of the valve, passing through the junction of the valve tissue of the patient's adjacent tissue to the leaflet and the heart wall, and then rotating around the root 132, along The valve sewing section 112 extends circumferentially and abuts the outer surface of the valve sewing section 112.
  • the junction of adjacent tissue valve leaflets refers to the junction between the anterior mitral valve and the posterior mitral valve (physiological anatomy is the joint valve of the mitral valve), the anterior tricuspid valve and the third The junction between the posterior mitral valve, the junction between the anterior tricuspid valve and the tricuspid valve, and the junction between the posterior tricuspid valve and the tricuspid valve.
  • the leaflets are made of animal tissue or high molecular polymer.
  • the animal tissue is pig pericardium, bovine pericardium, horse pericardium, etc.
  • the high molecular polymer is polytetrafluoroethylene, polyurethane, or silica gel.
  • the bracket 110 is a self-expanding bracket made of shape memory material or elastic material.
  • the material of the bracket 110 is a nickel-titanium shape memory alloy.
  • the bracket 220 is formed by integrally engraving a tube of shape memory material.
  • the bracket 220 is made by integrally carving a nickel-titanium shape memory alloy tube.
  • the flank 131 is an arc-shaped structure.
  • the flank 131 expands along the outer surface of the sewed section of the valve in a natural state.
  • the patient's tissue valve leaflets and adjacent tendons The cable is clamped between the side flap 131 and the valve sewing section 112.
  • the design of the arc-shaped structure allows the lateral wings 131 to cling to the outer surface of the valve sewing section 112, and the lateral wings 131 can simultaneously clamp the valve leaflets and the tendon, while the lateral wings 131 are inserted into the tendon gap The clamping effect is also enhanced.
  • the clamping piece 130 and the valve sewing section 112 in this application are designed separately, and then connected together after processing, the side wings 131 can be wound around the The rotation of the root 132 can facilitate the side flap 131 to realize the function of clamping the leaflet and its adjacent tendon.
  • the designer can balance the support force of the stent while pursuing that the clamping member 130 has a larger clamping force ;
  • the shaping process of the clamping member 130 is relatively simple, and the fatigue performance is good.
  • FIG. 2d it is different from the traditional way of clamping the leaflet (only axial clamping can be performed from the area where the leaflet is relatively free of the tendon) (FIG. 1c and FIG. 1d).
  • the valve sewing section 112 can be expanded circumferentially along the outer surface of the valve sewing section 112 to achieve the purpose of one clamping member simultaneously clamping the adjacent leaflet tissue and tendon, improving the anchoring effect and effectively reducing the space between adjacent valve leaflets Of reflux.
  • the flanks 131 pass through the junction of the patient's adjacent tissue leaflets (the black solid rectangle in the figure), reach between the leaflets and the heart wall and rotate around the root, which can avoid affecting the original
  • the movement of the mitral valve leaflet maintains the normal blood supply to the heart, and the positioning time is more abundant, which is helpful for the doctor to adjust the position and improve the accuracy of the positioning.
  • the root portion 132 is fixedly connected at the junction (boundary) of the valve sewing section 112 and the support section 111 by means of gluing, welding, winding, clamping, etc.
  • the root 132 is located at the junction of adjacent tissue leaflets of the target affected area.
  • FIGS. 3a and 3b in one of the embodiments, when the clamping member 130 is released, the root 132 (positions 132a and 132b in FIG. 3b) is located at the anterior valve of the patient’s mitral valve. Posterior lobe junction location (positions A and B in Figure 3a).
  • This design makes the flanks 131 closer to the junction of the adjacent tissue leaflets of the patient during the release process, which facilitates the flanks 131 to pass through the junction of the adjacent tissue leaflets of the patient and reach the leaflets and the heart wall
  • the distal end of the side wing 131 can interfere with the position of the patient's valve annulus, cooperate with the support section 111 to clamp the patient's valve annulus, and enhance the clamping effect.
  • the clamping member 130 includes two side wings 131, and the side wings 131 are arranged symmetrically.
  • Such a design makes the clamping member 130 compressed in the sheath When the rear is released, the side wings 131 can be released symmetrically, which is beneficial to the effect of clamping and anchoring.
  • the ends of both sides of the clamping member 130 are arc-shaped. The advantage of such a design is that the use of the arc-shaped end can avoid puncturing the heart wall tissue and causing bleeding.
  • the side wings 131 have a single or multiple continuous arc-shaped configurations, providing a larger clamping area and enhancing the clamping effect.
  • the side wings 131 located on both sides of the clamping member 130 are connected in a free state to form a closed-loop structure, and the connection means include clamping, welding, and stitching.
  • the side wings 131 on both sides of the root of the clamping member 130 are an integral structure wound by a shape memory alloy wire.
  • the clamping member 130 is provided with a convex point 133 to facilitate insertion into the sheath.
  • the diameter of the support section 111 is larger than the diameter of the valve sewing section 112, and the support section 111 is splayed out along its axis into an inverted cone shape with a cone angle of 60- 160°. In one of the embodiments, the cone angle is 135°.
  • This design can play the role of automatic positioning and support, that is, when the replacement stent with the valve is released at the implantation position, the support section 111 automatically presses against the original heart valve annulus to assume the function of automatic positioning, and It can provide support after the replacement stent is released and prevent the replacement stent from falling into the ventricle. As shown in FIGS.
  • the outer surface of the supporting section 111 is partially covered with a film 140, or the outer surface of the valve sewing section 112 is partially covered with a film 140, or both
  • the film 140 is partially covered, and the material of the film 140 includes polytetrafluoroethylene, polyethylene, polypropylene, polyurethane, silicone, etc., to effectively prevent perivalvular leakage.
  • a hole 1120 is provided in the distal portion of the valve sewing section 112, and the root 132 is wound through the hole 1120.
  • 6a is a double hole, the diameter of the hole 1120 is slightly larger than the diameter of the root portion 132; as shown in FIG. 6b, four holes are arranged on the distal portion of the valve sewing section 112 side by side up and down This design is to improve the connection strength of the root portion 132 and the valve sewing section 112 to prevent the root portion 132 from rotating in the hole 1120; as shown in FIG. 6c, in the valve sewing section 112
  • the distal part of the is provided with four holes side by side but dislocated up and down.
  • This design is also to prevent the root 132 from rotating in the hole 1120; as shown in FIG. 6d, in the valve sewing section
  • the distal end portion of 112 is provided with two upper and lower non-circular holes 1121, and two nickel-titanium alloy wires of the root portion 132 pass through the non-circular holes 1121.
  • a non-circular hole 1121 and two circular holes 1120 are provided on the distal portion of the valve sewing section 112, and the two nickel-titanium alloy wires constituting the root portion 132 respectively pass through the Non-round holes 1121 and round holes 1120.
  • a gap 1122 is provided on the distal portion of the valve sewing section 112, the root 132 rides on the gap 1122, and the gap 1122
  • the outer surface is sleeved with a metal jacket 1123.
  • a metal jacket 1123 Such a design can make the root portion 132 and the distal end portion of the valve sewing section 112 firmly connected, and can withstand the torque caused by the side wings rotating around the root portion 132.
  • the outer surface of the metal jacket 1123 is provided with a slit 1124. The width of the slit 1124 is adapted to the diameter of the root 132.
  • This design can prevent the root 132 from the gap 1122. Slip off.
  • a gap 1122 is provided on the distal portion of the valve sewing section 112, and the root 132 rides on the gap 1122 and passes through the Hole 1121.
  • the side wing 131 when the same clamping member 130 includes only a single side wing 131, the side wing 131 has a single or multiple continuous arc-shaped configurations. One end of the holder 130 is curved. As shown in FIG. 7c, the side wings (131a and 131b) in the different holding members 130 have different lengths along the outer surface of the valve sewing section in the free state (L1 ⁇ L2). This design allows the width of different flank clamps to be adjusted with the clamped leaflets. For example, the length of the axial expansion of the posterior mitral valve is longer than that of the anterior mitral valve. The flanks are longer than the flanks of the front flap to increase the clamping area and enhance the clamping effect.
  • the clamping members 130a and 130b each include a side wing 131a and 131b, and the roots 132a and 132b are fixed to the valve sewing section and the support section
  • the roots 132a and 132b are located at the junction of adjacent tissue leaflets of the target affected area.
  • the roots 132a and 132b are located at the junction of the anterior and posterior valves of the patient's mitral valve.
  • Such a design can independently control the loading and releasing of the side wings 131a and 131b.
  • the present application also provides a delivery system 160 for a stent-valve prosthesis
  • the delivery system includes a stent-valve prosthesis, an outer sheath 161, a stent sheath 162, and a stent sheath The core 163 and the holder sheath 164.
  • the stent-valve prosthesis includes a stent, a valve leaflet (not shown), and a holder 130.
  • the stent includes a support section 111 and a valve sewing section 112.
  • the stent sheath 162 is The clamping member sheath 164 is located inside the outer sheath 161, the clamping member sheath 164 is located outside the stent sheath 162, and the valve sewing section 112 is located at the distal end portion of the stent sheath 162 after being compressed Inner, the support section 111 is located in the distal portion of the outer sheath 161 after being compressed, the proximal end of the valve sewing section 112 is connected to the distal end of the stent sheath core 163, and the stent sheath core 163 Located in the stent sheath 162, the clamping member 130 is compressed and located in the distal portion of the clamping member sheath 164, the proximal end of the outer sheath 161 is fixedly connected to the outer sheath operating member 1610, the The proximal end of the stent sheath 162 is fixedly connected to the stent sheath operating member 1620, the proximal end of the
  • the clamping member 130 has three forms in order from compression to full release.
  • the first form is that the clamping piece 130 is compressed in the clamping piece sheath 164
  • the second form is the flanks of the clamping piece 130 131 moves along the radial direction of the valve sewing section 112, passes through the junction of the adjacent tissue leaflets of the patient, and reaches between the leaflets and the heart wall.
  • the third form is that the lateral wings 131 rotate around and adhere to the root 132
  • the outer surface of the valve sewing section 112 is made by the valve.
  • a clamping member sheath core 165 is further provided in the clamping member sheath 164, the clamping The distal end of the member sheath core 165 is in contact with the clamping member 130, and the proximal end of the clamping member sheath core 165 is fixedly connected to the clamping member sheath core operating member 1650.
  • the distal end of the gripper sheath 164 and the distal end of the gripper sheath core 165 are both flexible, the purpose of which is to enable the gripper sheath 164 and the gripper sheath core 165 to conform Deformation of the clamping member 130.
  • the clamping member 130 When the clamping member 130 partially exposes the clamping member sheath 164, the clamping member sheath 164 and the clamping member sheath core 165 are pushed integrally so that the exposed portion of the clamping member 130 arches toward the ventricular wall From the beginning, the lateral wings 131 pass through the junction of the adjacent tissue leaflets of the patient and reach between the leaflets and the heart wall; this process is reversible, pulling the clamping member sheath 164 and the clamping member sheath core 165 as a whole The exposed part of the clamping member 130 can be restored to a non-arched state, so that the doctor can adjust the positioning multiple times to improve the positioning effect.
  • the side wings 131 are compressed along the root portion 132 in a direction opposite to the deployment direction and straightened into the Clamping member sheath 164.
  • the lateral wings 131 are fully exposed along the circumferential direction of the valve sewing section 112 into an arc-shaped structure when the clamping member sheath 164 is exposed, thereby improving clamping strength.
  • the cross section of the holder sheath 164 is non-circular. Compared with the circular cross section, the non-circular cross section can make full use of space and reduce the size of the sheath tube.
  • the delivery system 160 in this application further includes a clamping member guide wire 166, the clamping member guide wire 166 is located in the clamping member sheath core 165, and the clamping member The proximal end of the guide wire 166 is fixedly connected to the guide wire operation member 1660 of the clamping member.
  • the side wings 131 are compressed along the root portion 132 in a direction opposite to the deployment direction to form a gap 1310.
  • the distal end of the clamping member guide wire 166 exits from the The slot 1310 passes through.
  • This design can ensure that the side wing 131 can be fully opened when the clamping member guide wire 166 is pulled away from the slot 1310, avoiding the side wing 131 from being clamped
  • the sheath 164 is deployed prematurely along the circumferential direction of the valve sewing section 112 to ensure that the patient's tissue valve leaflets and the adjacent tendon cord are clamped to the lateral wings 131 and the valve sewing section 112 after the release is completed between.
  • a delivery system 160 of the stent-valve prosthesis includes a stent-valve prosthesis, an outer sheath 161, a stent sheath 162, a stent sheath core 163, and a clamp sheath 164
  • the stent-valve prosthesis 100 includes a stent, a leaflet (not shown), and a clamping member
  • the stent includes a supporting section 111 and a valve sewing section 112
  • each of the clamping members includes a single or two flanks 131
  • the side wing 131 has a root 132 parallel to the longitudinal axis of the stent 110, the side wing 131 can rotate around the root 132
  • the clamping member is fixedly connected to the valve sewing section through the root 132 112
  • the outer surface of the distal portion is provided, and the delivery system includes a stent-valve prosthesis, an outer sheath 161, a stent sheath 162, a stent sheath core
  • the side wings 131 of the clamping member are compressed in the direction opposite to the deployment direction along the root portion 132, they are pre-installed in the clamping member sheath 164 in a first form (referring to the clamping member being Compressed in the lumen), the distal end of the clamping member guide wire 166 passes through the slit 1310 formed by the side wing 131 due to compression; the valve sewing section 112 is compressed and received The stent sheath 162; then the compressed stretch section 111, the clamping member sheath 164 together with the stent sheath 162 are received in the outer sheath 161. The distal end of the outer sheath 161 enters the mitral valve of the patient through the apex.
  • the stent-valve prosthesis is delivered to the target site of the patient, and the outer sheath operating member 1610 is operated so that the outer sheath 161 slides axially proximally until the spread Segment 111 is released and deployed; the position of the distracting segment 111 is adjusted so that it is placed above the annulus of the patient and against the atrial tissue.
  • the side flaps 131 of the present application are released before the valve sewing section 112 is released.
  • the advantage of this design is that, while positioning by the side flaps 131, the partial opening of the valve sewing section 112 is avoided to cause compression of the natural valve leaflets.
  • the failure time of the function of the valve leaflet when the natural valve leaflet has failed and the artificial valve leaflet fails to work affects the normal heart blood supply function of the patient.
  • the clamping member 130 Since the clamping member 130 has shape memory, when the guide wire 166 gradually disengages from the clamping member 130, the side wings 131 rotate around the root portion 132, and the clamping member 130 moves from the first The second form is transformed into the third form (means that the flank 131 rotates around the root 132 and abuts against the outer surface of the valve sewing section 112). At this time, the patient's tissue valve leaflets and the adjacent tendon cord are clamped in the Between the lateral flap 131 and the valve sewing section 112.
  • a stent-valve prosthesis 200 including a stent 210, a valve leaflet (not shown), and a clamping member 230.
  • the stent 210 It includes a support section 211 and a valve sewing section 212, the proximal end of the support section 211 is connected to the distal end of the valve sewing section 212, the valve leaflet is connected to the valve sewing section 212, the After the support section 211 is released, it is placed above the annulus of the patient and abuts against atrial tissue.
  • the stent-valve prosthesis 200 includes two clamping members 230, which are formed by winding a shape memory alloy wire, or The clamping member 230 is formed by cutting and shaping a shape memory alloy tube.
  • the clamping member 230 includes two side wings 231a and 231b.
  • the side wings 231 have a root 232 parallel to the longitudinal axis of the bracket 210 and can rotate about the root 232.
  • the root 232 is glued, welded, wound It is fixedly connected to the outer surface of the distal portion of the valve sewing section 212 by means of piercing, clamping, etc., and the clamping member 230 is fixedly connected to the outer surface of the valve sewing section 212 through the root 232.
  • the flanks 231 are displaced in the radial direction of the valve sewing section 212.
  • the flanks 231 are arc-shaped structures.
  • the flanks 231 expand along the outer surface of the valve sewing section 212 in a natural state. After the flanks 231 are released, the patient's tissue valve leaflets and adjacent tendon cords are clamped at Between the flanks 231 and the valve sewing section 212.
  • the side wings 231 located on both sides of the root 232 of the clamping member 230 have an open-loop structure in a free state.
  • the advantage of this design is to avoid that the side wings 131 on both sides enter a sheath tube at the same time, causing the sheath tube to increase in size.
  • the side wings 231 on both sides of the clamping member 230 are an integral structure wound by a shape memory alloy wire, or the side wings 231 on both sides of the clamping member 230 are made of shape memory alloy The tube is cut in one piece.
  • the present application also provides a delivery system 260 of a stent-valve prosthesis.
  • the delivery system 260 includes a stent-valve prosthesis, an outer sheath 261, a stent sheath 262, and a stent A sheath core 263 and a clamp sheath 264
  • the stent-valve prosthesis includes a stent, a valve leaflet (not shown), and a clamp 230
  • the stent includes a support section 211 and a valve sewing section 212
  • the holder sheath 264 are located in the outer sheath 261, the holder sheath 264 is located outside the stent sheath 262, the distal end of the holder sheath 264 is flexible, and the valve sewing section 212 is located in the distal portion of the stent sheath 262 after being compressed, the support section 211 is located in the distal
  • the side wings 231a and 231b on both sides of the clamping member 230 are compressed and loaded in the two clamping member sheaths 264a and 264b, respectively.
  • the distal portion of the holder sheath 264 is provided with a slit 2642.
  • the slit 2642 has directionality, so that the distal end portion of the holder sheath 264 has at least two bends, and the distal end portion of the holder sheath 264 can flexibly bend according to the bend.
  • the clamping piece sheath 264 is further provided with a clamping piece sheath core 265, the distal end of the clamping piece sheath core 265 is flexible, the distal end of the clamping piece sheath core 265 and the clamping piece 230 In abutment, the proximal end of the clamping member sheath core 265 is fixedly connected to the clamping member sheath core operating member 2650.
  • the distal end of the gripper sheath 264 and the distal end of the gripper sheath core 265 of the present application are both flexible. Operating the handle located outside the patient makes the gripper sheath 264 arch toward the ventricular wall. The clip sheath 264, together with the flanks 231 located therein, arches radially from the patient's adjacent tissue leaflet junction to reach between the leaflet and the heart wall; this process is reversible, operating the handle outside the patient's body, such as The sheath 264 of the clamping member is restored to a non-arched state, so that the doctor can adjust the positioning multiple times and improve the positioning effect.
  • the handle outside the patient's body is operated so that the clamping member sheath 264 and the side wings 231 located therein rotate around the root portion 232.
  • the patient's tissue valve leaflets and the adjacent tendon cord are clamped in the clamp Between the holder sheath 264 and the valve sewing section 212.
  • the clamping member sheath 264 is withdrawn relative to the clamping member sheath core 265, and the lateral wings 231 are gradually released. After the lateral wings 231 are released, the patient's tissue valve leaflets and adjacent tendon cords are clamped in the Between the flanks 231 and the valve sewing section 212.
  • a delivery system 260 of the stent-valve prosthesis includes a stent-valve prosthesis, an outer sheath 261, a stent sheath 262, a stent sheath core 263, and a clamp sheath 264
  • the stent-valve prosthesis includes a stent, a valve leaflet (not shown) and a clamping member
  • the stent includes a supporting section 211 and a valve sewing section 212
  • each of the clamping members includes a single or two flanks 231
  • the lateral wing 231 has a root 232 parallel to the longitudinal axis of the stent 210, the lateral wing 231 can rotate around the root 232, and the clamping member is fixedly connected to the valve sewing section 212 through the root 232 The outer surface of the distal portion.
  • the side wings 231 of the clamping member are compressed in the direction opposite to the deployment direction along the root portion 232, they are pre-installed in the clamping member sheath 264 in a first form (referring to the clamping member being Compressed in the lumen); the valve sewing section 212 is compressed into the stent sheath 262; then the compressed stretch section 211, the clamping member sheath 264 together with the stent The sheath 262 is received in the outer sheath 261 together. The distal end of the outer sheath 261 enters the mitral valve of the patient through the apex.
  • the gripping member 230 changes from the second form to the third form (refers to the side wing 231 rotating around the root 232 and abutting the outer surface of the valve sewing section 212), at this time the patient's tissue valve leaflet and adjacent tendon cord It is clamped between the clamp sheath 264 and the valve sewing section 212.
  • the stent-valve prosthesis 300 described in this application can also be used in the field of tricuspid valve replacement.
  • the tricuspid valve structure 020 is composed of a tricuspid valve annulus 021, a septal valve 022, an anterior valve 023, a posterior valve 024, a chord 025, a papillary muscle 026, a right atrium 027, and a right ventricle 028 Overall.
  • FIGS. 24a and 24b the tricuspid valve structure 020 is composed of a tricuspid valve annulus 021, a septal valve 022, an anterior valve 023, a posterior valve 024, a chord 025, a papillary muscle 026, a right atrium 027, and a right ventricle 028 Overall.
  • FIGS. 24a and 24b the tricuspid valve structure 020 is composed of a tricuspid valve annulus 021, a septal valve 022, an anterior valve 023, a posterior valve 024, a chord 025, a papillary muscle 026, a right
  • the stent-valve prosthesis 300 includes three clamping members 330, and each of the clamping members 330 includes two side wings 331, and the side wings 331 Having a root 332 parallel to the longitudinal axis of the stent 310, the clamping member 330 is fixedly connected to the outer surface of the distal portion of the valve sewing section 312 through the root 332, and the lateral wings 331 can be wound around the root 332 turns.
  • the root 332 When the clamping member 310 is released, the root 332 is located at the junction of the anterior valve 023 and the septum 022 of the patient's tricuspid valve, or the root 332 is located at the junction of the anterior valve 023 and the posterior valve 024 of the patient's tricuspid valve The location, or the root 332 is located at the junction of the posterior valve 024 and the septal valve 022 of the patient's tricuspid valve.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

一种支架瓣膜假体及其输送***，包括支架（110）、瓣叶和夹持件（130），支架（110）包括支撑段（111）和瓣膜缝制段（112），支撑段（111）的近端与瓣膜缝制段（112）的远端连接，瓣叶被连接在瓣膜缝制段（112）上，支撑段（111）释放后被放置在患者瓣环上并抵靠心房组织，夹持件（130）包括一个或者多个侧翼（131），夹持件（130）的一端被固定连接在瓣膜缝制段（112）的外表面，夹持件（130）从压缩到完全释放依次具有三个形态，第一形态为侧翼（131）被压缩在控制装置内；第二形态为侧翼（131）沿瓣膜缝制段径向方向伸展，穿过相邻组织的瓣叶交界处到达瓣叶与心壁之间；第三形态为侧翼（131）沿瓣膜缝制段（112）周向伸展并贴靠瓣膜缝制段（112）的外表面，释放完毕后患者的组织瓣叶以及临近腱索被夹持在侧翼（131）和瓣膜缝制段（112）之间，有利于提高瓣膜支架锚定牢固性，提高手术成功率。

Description

支架瓣膜假体及其输送***
相关申请
本申请要求2018年12月3日申请的，申请号为201811462573.0，名称为“一种支架瓣膜假体及其输送***”的中国专利申请的优先权，在此将其全文引入作为参考。
技术领域
本申请属于医疗器械领域，具体涉及一种支架瓣膜假体及其输送***。
背景技术
二尖瓣结构由二尖瓣环、前瓣、后瓣、腱索、***肌、左心房和左心室构成的整体。其中前瓣叶与后瓣叶之间被联合分割，分别位于前外侧部和后中部。来自双侧***肌的腱索***至瓣叶中，根据***部位不同，腱索整体分为三类：联合腱、前叶腱、后叶腱。联合腱顾名思义***至瓣膜联合区。通常由***肌发出的单腱呈扇形分叉，***至瓣叶联合之中。前叶腱***至前叶的游离缘，为瓣膜前叶提供必要的支持。后叶腱则同时***后叶的游离缘和基底部。
二尖瓣疾病是最常见的瓣膜病，主要是由于瓣膜本身病理改变或左心***病变引起的继发改变而导致。单就美国1994-2003年的统计数据中显示，二尖瓣手术的数量在过去的十年中翻了一番。2003年二尖瓣置换术的数量更是高达65000例，其中部分患者同时进行了冠状动脉旁路移植术。尽管有见文献报道称二尖瓣置换术术后死亡率及并发症较之二尖瓣修复术严重，但无可否认，对于某些患者，二尖瓣置换术乃是延续其生命的唯一方法。可喜的是，经过近几年的技术发展，相比于传统的开胸、开心、建立体外循环等大创伤手术，经导管介入的置换手术能够降低手术难度，缩短患者恢复时间，减轻患者痛苦，因而经导管介入的置换手术逐步成为二尖瓣置换术的主流术式。而经导管行二尖瓣置换术，目前亟待解决的问题有如下几点：置换器械如何能够准确定位在所需的位置；人工瓣膜的载体(一般是支架结构)如何牢固地锚定在所需的位置；置换器械如何适应瓣环的生理结构的差异性。下面列举了目前传统技术中，不同的二尖瓣置换器械的技术要点。
专利CN103079498A描述了一款经导管二尖瓣假体，其锚固件具有心房裙部、环形区和心室裙部，所述的心室裙部还包括安置在所述心室裙部的前部上的三角锚固耳片，所述三角锚固耳片适于抵靠着病人二尖瓣的前小叶的第一侧上的第一纤维三角区锚固，从而使 前小叶和毗邻的腱索被俘获在所述三角锚固耳片与所述锚固件的前表面之间。所述的心室裙部还包括安置在所述心室裙部的前部上的第二三角锚固耳片，所述第二三角锚固耳片适于抵靠着与所述第一纤维三角区相对的第二纤维三角区锚固，从而使前小叶和毗邻的腱索被俘获在所述第二三角锚固耳片与所述锚固件的前表面之间。所述的心室裙部还包括安置在所述心室裙部的后部上的后心室锚固耳片，并且其中所述后心室锚固耳片适于锚固在病人的二尖瓣的后小叶上，从而使所述后心室锚固耳片座合于该后小叶与病人心脏的心室壁之间。根据专利中的释放方式，径向扩张所述心室裙部从而使天然二尖瓣小叶径向向外移位，在径向扩张的同时将瓣叶及毗邻腱索夹持。该设计的问题在于，该锚定耳片的释放不可逆返，难以确保一次释放就能够夹持住瓣叶及其腱索；在锚定耳片释放之前，所述环形部就已经部分打开压迫天然瓣叶，这时候出现一个天然瓣叶已经失效同时人工瓣叶未能工作的瓣叶功能失效时间，影响患者正常心脏供血功能；受限于释放位置、释放形态及腱索环境，锚定耳片仅能从瓣叶相对没有腱索的区域进行包覆夹持，其夹持稳固性不够理想。
专利US8449599中，Edwards公开了一种二尖瓣置换支架，在所述的支架外表面包括至少一个夹持件。当所述支架被压缩在鞘管时，所述夹持件与所述支架外表面的空隙用以捕获瓣叶。当所述支架被逐渐释放时，所述夹持件与所述支架外表面的空隙越来越小，从而将其中的瓣叶夹住。该设计的问题有三点，一是支架和夹持件一体切割，夹持件的夹持能力受管材壁厚影响较大，而壁厚又同样影响着支架，当支架支撑力过大时会导致压迫二尖瓣附近组织例如主动脉瓣的正常工作，设计者难以在平衡支架支撑力的同时追求夹持件有较大的夹持力；二是夹持件翻转定型的工艺复杂，就算是定型成功，夹持件的耐疲劳性能也有待商榷；三是所述夹持件仅能从瓣叶相对没有腱索的区域进行包覆夹持，其夹持稳固性不够理想；四是同一个夹持件仅能夹持单片瓣叶，瓣叶之间的反流无法避免。
专利US20080033541公开了一种将二尖瓣瓣膜支架固定在二尖瓣瓣环上的方法，其使用固定在支架上的一个撑开件抵触大部分的左心房，从而达到锚定效果。该设计的问题在于，人工二尖瓣瓣膜在运动过程中承受较大的上下移位的冲击力，如果所述的撑开件刚度不足，则其难以起到锚定的作用；但倘若所述的撑开件刚性过度，则容易损伤心房组织。
专利US20130053950描述了一款二尖瓣瓣膜支架，其在瓣膜支架的心室部分连接有拉力单元，所述拉力单元的一端连接在支架上，另一端连接在心肌上，所述拉力单元用来降低由于心室收缩带来的应力。该设计的问题在于，不同于二尖瓣修复器械，置换支架在心脏收缩时受到较大的冲击，仅靠所述拉力单元并不能保证其不会被冲离瓣环，即使是不会冲离瓣环，亦会使置换支架位置偏移，导致大量的返流。
专利US20140005778公开了一种将二尖瓣瓣膜支架固定在二尖瓣环上的方法，其引入 了一个瓣膜支架固定装置，所述瓣膜支架固定装置由上下两片夹片组成，所述夹片由至少两个桥接单元连接。所述瓣膜支架固定装置可以装入鞘内，出鞘后二尖瓣瓣环位于上下两片夹片之间，而后再输送瓣膜支架，让其在所述固定装置中撑开。该设计的问题在于，不同患者之间的二尖瓣结构差异很大，供应商难以用有限规格的固定装置去夹持不同的患者；在心脏搏动时期，二尖瓣后瓣附着的瓣环组织的尺寸变化很大，这也给该设计带来困难。
专利US20140142691公开了一种固定二尖瓣瓣膜支架的方法，其在主动脉上安置了一个辅助锚定的支架，所述辅助锚定的支架与二尖瓣瓣膜支架连接，以求达到固定二尖瓣瓣膜支架的目的。该设计的局限在于，在主动脉放置辅助锚定的支架会增加手术的难度，而且带来对主动脉的损伤风险。辅助锚定的支架与二尖瓣瓣膜支架之间的连接杆会影响主动脉瓣膜及其连带组织的正常功能。倘若是主动脉瓣膜支架与二尖瓣瓣膜支架同时放置，适合手术的患者将非常稀少，就算是有这类患者，手术难度也大大提高。而且互为连接将有互相影响的风险，一旦放置位置出现偏差，或者由于后续心脏运动中使得支架位置出现偏差，直接影响患者生命安全。
目前临床结果表明，并未有一款理想的二尖瓣置换器械。主要原因在于二尖瓣瓣环具有特殊的生理结构，且在瓣环下方有复杂的生理环境，造成产品准确定位和固定非常困难。同样的，三尖瓣置换器械与二尖瓣置换器械面临着类似的问题。综上所述，尽管以上所描述的技术在瓣膜修复上分别都有一定的效果，但是传统的产品在锚定机构的设计上或多或少地存在缺陷。在二尖瓣或者三尖瓣置换手术领域，亟需一种具备定位准确和牢固锚定的假体。
发明内容
本申请的目的是在于改进和弥补传统技术的缺陷而提出一种可以有效解决多种问题的支架瓣膜假体。本申请通过在支架上设置有夹持件，所述夹持件包括侧翼，所述侧翼具有与所述支架纵轴线平行的根部且能够绕所述根部转动，所述侧翼在释放的过程中沿所述瓣膜缝制段径向方向位移，穿过患者的相邻组织瓣叶交界处到达瓣叶与心壁之间，继而绕所述根部转动并贴靠所述瓣膜缝制段的外表面。释放完毕后患者的组织瓣叶以及临近腱索被夹持在所述侧翼和所述瓣膜缝制段之间，有利于提高瓣膜支架锚定牢固性，大大提高手术成功率。
本申请的目的是通过以下技术方案实现的：
一种支架瓣膜假体，包括支架、瓣叶和夹持件，所述支架包括支撑段和瓣膜缝制段，所述支撑段的近端与所述瓣膜缝制段的远端连接，所述瓣叶被连接在所述瓣膜缝制段上， 所述支撑段释放后能够被放置在患者瓣环上并抵靠心房组织，所述夹持件包括一个或者多个侧翼，所述夹持件的一端被固定连接在所述瓣膜缝制段的外表面，所述夹持件从压缩到完全释放依次具有三个形态，第一形态为所述侧翼被压缩在控制装置内；第二形态为所述侧翼沿所述瓣膜缝制段径向方向伸展，能够穿过相邻组织的瓣叶交界处到达瓣叶与心壁之间；第三形态为所述侧翼沿所述瓣膜缝制段周向伸展并贴靠所述瓣膜缝制段的外表面。
本申请的目的还可以通过以下技术方案进一步实现：
在其中一个实施例中，所述侧翼具有根部，所述夹持件通过所述根部固定连接在所述瓣膜缝制段的外表面。
在其中一个实施例中，所述侧翼能够绕所述根部转动。
在其中一个实施例中，所述根部与所述支架纵轴线平行。
在其中一个实施例中，所述根部被设置在所述瓣膜缝制段的远端部分上。
在其中一个实施例中，所述根部被固定在所述瓣膜缝制段与所述支撑段的连接处。
在其中一个实施例中，所述侧翼为弧形结构，所述侧翼在自然状态下沿所述瓣膜缝制段的外表面周向展开。所述侧翼释放完毕后患者的组织瓣叶以及临近腱索被夹持在所述侧翼和所述瓣膜缝制段之间。
在其中一个实施例中，当所述夹持件被释放时，所述根部位于目标患处的相邻组织瓣叶交界处。在其中一个实施例中，当所述夹持件被释放时，所述根部位于患者二尖瓣的前瓣与后瓣交界位置，或者所述根部位于患者三尖瓣的前瓣与隔瓣交界位置、或者所述根部位于患者三尖瓣的前瓣与后瓣交界位置、或者所述根部位于患者三尖瓣的后瓣与隔瓣交界位置。
在其中一个实施例中，所述侧翼在所述瓣膜缝制段被释放之前释放，这样设计的好处在于，通过所述侧翼进行定位的同时，避免瓣膜缝制段部分打开压迫天然瓣叶而导致出现一个天然瓣叶已经失效同时人工瓣叶未能工作的瓣叶功能失效时间，影响患者正常心脏供血功能。
在其中一个实施例中，所述夹持件为多个。
在其中一个实施例中，当同一个所述夹持件包括偶数个侧翼时，所述夹持件的两侧端部为弧形，所述侧翼为对称设置，其中每个所述侧翼具有单个或者多个连续的弧形构型。这样设计的好处在于采用弧形的端部能够避免刺伤心壁组织造成出血。在其中一个实施例中，所述夹持件上设置有凸点，以便于入鞘。
在其中一个实施例中，当同一个所述夹持件包括两个侧翼时，位于所述夹持件的根部两侧的所述侧翼在自由状态下连接成为闭环结构。在其中一个实施例中，位于所述夹持件 的根部两侧的所述侧翼在自由状态下通过夹持、焊接、缝绑等方式互为连接，或者位于所述夹持件的根部两侧的所述侧翼为形状记忆合金丝绕制的一体结构，或者位于所述夹持件的根部两侧的所述侧翼由形状记忆合金管一体切割而成。
在其中一个实施例中，当同一个所述夹持件包括两个侧翼时，位于所述夹持件的根部两侧的所述侧翼在自由状态下为开环结构。这样设计的好处在于避免两侧的所述侧翼同时进入鞘管造成鞘管尺寸增大。
在其中一个实施例中，当同一个所述夹持件仅包括单个侧翼时，所述侧翼具有单个或者多个连续的弧形构型，所述夹持件的一侧端部为弧形，不同的所述夹持件中的所述侧翼在自由状态下沿所述瓣膜缝制段的外表面展开的长度不相等。
在其中一个实施例中，所述根部采用胶接、焊接、绕穿、夹持等方式被固定连接在所述瓣膜缝制段。
在其中一个实施例中，在所述瓣膜缝制段的远端部分上设置有孔，所述根部绕穿在所述的孔中。
在其中一个实施例中，在所述瓣膜缝制段的远端部分上设置有缺口，所述根部骑跨在所述缺口处并绕穿在所述的孔中。
在其中一个实施例中，在所述瓣膜缝制段的远端部分上设置有缺口，所述根部骑跨在所述缺口处并在所述缺口的外表面套接夹套。在其中一个实施例中，所述夹套的外表面设置有切缝，切缝宽度适应所述根部的直径。
在其中一个实施例中，所述夹持件由形状记忆合金丝绕制而成，或者所述夹持件由形状记忆合金管材切割并定形而成。
在其中一个实施例中，所述支撑段的直径大于所述瓣膜缝制段的直径，所述支撑段沿其轴线向外张开成倒锥形，锥角为60-160°。在其中一个实施例中，所述锥角为135°。
在其中一个实施例中，所述瓣膜缝制段的外表面被部分覆膜，或者所述支撑段的外表面被部分覆膜，或者两者均被部分覆膜，所述膜的材料包括聚四氟乙烯、聚乙烯、聚丙烯、聚氨酯、硅胶等，以有效防止瓣周漏。
在其中一个实施例中，所述瓣叶由动物组织或高分子聚合物制成。在其中一个实施例中，所述的动物组织为猪心包、牛心包、马心包等，所述的高分子聚合物为聚四氟乙烯、聚氨酯、硅胶。
在其中一个实施例中，所述支架为自膨式支架，材质为形状记忆材料或弹性材料。在其中一个实施例中，所述支架材质为镍钛形状记忆合金。在其中一个实施例中，所述的支架采用形状记忆材料管一体雕刻制成。在其中一个实施例中，所述的支架为镍钛形状记忆 合金管一体雕刻制成。
本申请的目的还通过以下技术方案实现：
一种支架瓣膜假体的输送***，所述输送***包括支架瓣膜假体、外鞘、支架鞘、支架鞘芯和夹持件鞘，所述支架瓣膜假体包括支架、瓣叶和夹持件，所述支架包括支撑段和瓣膜缝制段，所述支架鞘与所述夹持件鞘被设置在所述外鞘内，所述夹持件鞘位于所述支架鞘外，所述瓣膜缝制段被压缩后位于所述支架鞘的远端部分内，所述支撑段被压缩后位于所述外鞘的远端部分内，所述瓣膜缝制段的近端与所述支架鞘芯的远端连接，所述支架鞘芯被设置在所述支架鞘内，所述夹持件被压缩后位于所述夹持件鞘的远端部分内，所述外鞘的近端固定连接在外鞘操作件上，所述支架鞘的近端固定连接在支架鞘操作件上，所述支架鞘芯的近端固定连接在支架鞘芯操作件上，所述夹持件鞘的近端固定连接在夹持件鞘操作件上。
在其中一个实施例中，所述夹持件鞘的截面为非圆形。
在其中一个实施例中，在所述夹持件鞘中还设置有夹持件鞘芯，所述夹持件鞘的远端和所述夹持件鞘芯的远端皆为柔性，所述夹持件鞘芯的远端与所述夹持件接触，所述夹持件鞘芯的近端固定连接在夹持件鞘芯操作件上。
在其中一个实施例中，当所述夹持件需要被压缩进入所述夹持件鞘时，所述夹持件以与展开方向相反的方向被拉直压缩在所述夹持件鞘内。
在其中一个实施例中，所述输送***还包括夹持件导引丝，所述夹持件导引丝位于所述夹持件鞘芯内，所述侧翼沿所述根部往与展开方向相反的方向压缩后形成缝隙，当所述夹持件处于第一形态时，所述夹持件导引丝的远端从所述缝隙中穿过，所述夹持件导引丝的近端固定连接在夹持件导引丝操作件上。
在其中一个实施例中，所述夹持件鞘的远端部分设置有切缝。
在其中一个实施例中，旋转所述夹持件鞘操作件，能够使得所述夹持件鞘连同位于其中的所述侧翼绕所述根部转动。
同传统技术相比，本申请的优点在于：
1、区别于传统夹持瓣叶(仅能从瓣叶相对没有腱索的区域进行轴向夹持)的方式，本申请中所述夹持件上的所述侧翼在自然状态下沿所述瓣膜缝制段的外表面周向展开，实现一个夹持件同时夹持相邻的瓣叶组织和腱索的目的，提高锚定效果的同时有效降低了相邻瓣叶组织间的反流。
2、区别于传统技术中夹持过程会导致原有瓣叶立即不能工作，本申请在释放的过程中，所述侧翼从患者的相邻组织瓣叶交界处穿过到达瓣叶与心壁之间并绕所述根部转动， 从这个位置释放能避免影响原有二尖瓣瓣叶的运动，维持心脏正常供血，定位时间更充裕，有利于医生做位置调整，提高定位的准确性。
3、本申请的所述侧翼在所述瓣膜缝制段被释放之前释放，这样设计的好处在于，通过所述侧翼进行定位的同时，避免瓣膜缝制段部分打开压迫天然瓣叶而导致出现一个天然瓣叶已经失效同时人工瓣叶未能工作的瓣叶功能失效时间，影响患者正常心脏供血功能。
4、区别于传统夹持件与瓣膜支架的一体切割设计，本申请中所述夹持件与所述瓣膜缝制段为分离设计加工后再连接在一起，所述侧翼能够绕所述根部转动，能够方便所述侧翼实现夹持瓣叶及其相邻腱索的功能，设计者能够在平衡支架支撑力的同时，可以追求夹持件具有较大的夹持力；而且夹持件的定型工艺相对简单，疲劳性能好。
5、本申请所述侧翼为弧形结构，弧形结构的设计使得所述侧翼能够贴紧所述瓣膜缝制段的外表面，而且所述侧翼能够同时夹持瓣叶及腱索，同时所述侧翼穿插在腱索缝隙中同样增强了夹持效果。
6、本申请所述根部被固定在所述瓣膜缝制段与所述支撑段的连接处，这样的设计使得所述根部在释放过程中能更贴近患者的相邻组织瓣叶交界处，有利于所述侧翼从患者的相邻组织瓣叶交界处穿过到达瓣叶与心壁之间；同时所述侧翼的远端能够抵触患者瓣环位置，配合所述支撑段夹持患者瓣环，增强夹持效果。
7、本申请所述夹持件鞘的远端和所述夹持件鞘芯的远端皆为柔性，其目的在于使得所述夹持件鞘以及所述夹持件鞘芯能够顺应所述夹持件的变形。当所述夹持件部分露出所述夹持件鞘时，整体推动所述夹持件鞘及所述夹持件鞘芯使得所述夹持件露出部分往心室壁方向拱起，所述侧翼从患者的相邻组织瓣叶交界处穿过到达瓣叶与心壁之间；同时此过程可逆，整体拉动所述夹持件鞘及所述夹持件鞘芯可让所述夹持件露出部分恢复为非拱起的状态，使得医生可多次调整定位，提高定位准确性。
8、本申请中所述夹持件导引丝位于所述夹持件鞘芯内，所述侧翼沿所述根部往与展开方向相反的方向压缩后形成缝隙，所述夹持件导引丝的远端从所述缝隙中穿过，这样的设计能够确保所述侧翼在所述夹持件导引丝从所述缝隙中抽离时方能完全打开，避免所述侧翼在从所述夹持件鞘释放时过早地沿所述瓣膜缝制段的外表面展开，确保释放完毕后患者的组织瓣叶以及临近腱索被夹持在所述侧翼和所述瓣膜缝制段之间。
附图说明
为了更清楚地说明本申请实施例或传统技术中的技术方案，下面将对实施例或传统技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请 的实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据公开的附图获得其他的附图。
图1a和图1b示出了二尖瓣结构的示意图，图1c和图1d示出了二尖瓣夹持件传统技术的示意图。
图2a至图2d示出了本申请的支架瓣膜假体的一个实施方式的示意图。
图3a和图3b示出了本申请的支架瓣膜假体的另一个实施方式的示意图。
图4a至图4f示出了本申请夹持件的多种实施方式的示意图。
图5a至图5d示出了本申请的支架瓣膜假体的多个实施方式的示意图。
图6a至图6h示出了本申请夹持件与瓣膜缝制段之间的多种连接方式的示意图。
图7a至图7f示出了本申请夹持件的多种实施方式的示意图。
图8a至图8e示出了本申请一实施例支架瓣膜假体的输送***的一种实施方式的示意图。
图9a至图9e示出了本申请一实施例支架瓣膜假体的输送***的另一种实施方式的示意图。
图10a至图15c逐步示出了本申请一实施例的支架瓣膜假体实现固定的一种操作过程。
图16a和图16b示出了本申请另一实施例的支架瓣膜假体的示意图。
图17a至图17d示出了本申请一实施例支架瓣膜假体的输送***的另一种实施方式示意图。
图18a至图23c逐步示出了本申请一实施例的支架瓣膜假体实现固定的另一种操作过程。
图24a和图24b示出了三尖瓣结构的示意图，图24c和图24d示出了本申请一实施例的支架瓣膜假体应用在三尖瓣领域时的示意图。
具体实施方式
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
除非另有定义，本文所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本文中在本申请的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本申请。本文所使用的术语“及/或”包括一个或多个相关 的所列项目的任意的和所有的组合。
本申请所述的远端是指远离心尖的一端，所述的近端是指接近心尖的一端。
具体实施例一：
二尖瓣结构010如图1a和图1b所示，二尖瓣结构010是由二尖瓣环011、前瓣012、后瓣013、腱索014、***肌015、左心房016和左心室017构成的整体。其中前瓣叶012(A1、A2、A3)与后瓣叶013(P1、P2、P3)之间被联合分割，分别位于前外侧部和后中部。如图1c和图1d所示，传统产品Edwards的FORTIS和Neovasc的TIARA等均是利用固定在支架上的锚定耳片结构018从瓣叶游离处向瓣环处接近，然后从图1d所示位置将瓣叶夹持(图中省略支架主体未画)，无论是锚定耳片018***瓣叶底部的过程还是夹持结果均基本避开了腱索(锚定耳片018大致位于A2和P2区)，夹持效果十分有限，锚定不够牢固可靠。
如图2a-2c所示，为了提高定位和锚定的效果，本申请提供了一种支架瓣膜假体100，包括支架110、瓣叶(未显示)和夹持件130，所述支架110包括支撑段111和瓣膜缝制段112，所述支撑段111的近端与所述瓣膜缝制段112的远端连接，所述瓣叶被连接在所述瓣膜缝制段112上，所述支撑段111释放后被放置在患者瓣环以上并抵靠心房组织，所述支架瓣膜假体100包括两个所述夹持件130。每个所述夹持件130包括单个或者两个侧翼131，所述侧翼131具有与所述支架110纵轴线平行的根部132且能够绕所述根部132转动，所述夹持件130的一端通过所述根部132固定连接在所述瓣膜缝制段112远端部分的外表面，所述夹持件130从压缩到完全释放依次具有三个形态，第一形态为所述侧翼131被压缩在控制装置内；第二形态为所述侧翼131沿所述瓣膜缝制段112径向方向伸展，穿过患者的相邻组织瓣叶交界处到达瓣叶与心壁之间；第三形态为所述侧翼131沿所述瓣膜缝制段112周向伸展并贴靠所述瓣膜缝制段112的外表面。在释放的过程中所述侧翼131沿所述瓣膜缝制段径向方向位移，穿过患者的相邻组织瓣叶交界处到达瓣叶与心壁之间，然后绕所述根部132转动，沿所述瓣膜缝制段112周向伸展并贴靠所述瓣膜缝制段112的外表面。本申请中，所述相邻组织瓣叶交界处指的是二尖瓣前瓣与二尖瓣后瓣之间交界(生理解剖中为二尖瓣联合瓣处)、三尖瓣前瓣与三尖瓣后瓣之间交界、三尖瓣前瓣与三尖瓣隔瓣之间交界、以及三尖瓣后瓣与三尖瓣隔瓣之间交界。
在其中一个实施例中，所述瓣叶由动物组织或高分子聚合物制成。在其中一个实施例中，所述的动物组织为猪心包、牛心包、马心包等，所述的高分子聚合物为聚四氟乙烯、聚氨酯、硅胶。所述支架110为自膨式支架，材质为形状记忆材料或弹性材料。在其中一个实施例中，所述支架110材质为镍钛形状记忆合金。在其中一个实施例中，所述的支架 220采用形状记忆材料管一体雕刻制成。在其中一个实施例中，所述的支架220为镍钛形状记忆合金管一体雕刻制成。
如图2c所示，所述侧翼131为弧形结构，所述侧翼131在自然状态下沿所述瓣膜缝制段的外表面展开，所述侧翼131释放完毕后患者的组织瓣叶以及临近腱索被夹持在所述侧翼131和所述瓣膜缝制段112之间。弧形结构的设计使得所述侧翼131能够贴紧所述瓣膜缝制段112的外表面，而且所述侧翼131能够同时夹持瓣叶及腱索，同时所述侧翼131穿插在腱索缝隙中同样增强了夹持效果。区别于传统夹持件与瓣膜支架的一体切割设计，本申请中所述夹持件130与所述瓣膜缝制段112为分离设计，加工后再连接在一起，所述侧翼131能够绕所述根部132转动，能够方便所述侧翼131实现夹持瓣叶及其相邻腱索的功能，设计者能够在平衡支架支撑力的同时，可以追求所述夹持件130具有较大的夹持力；而且所述夹持件130的定型工艺相对简单，疲劳性能好。如图2d所示，区别于传统夹持瓣叶(仅能从瓣叶相对没有腱索的区域进行轴向夹持)的方式(图1c和图1d)，本申请中所述夹持件130能沿所述瓣膜缝制段112的外表面周向展开，实现一个夹持件同时夹持相邻的瓣叶组织和腱索的目的，提高锚定效果的同时有效降低相邻瓣叶组织间的反流。在释放的过程中，所述侧翼131从患者的相邻组织瓣叶交界处(图中黑色实心矩形处)穿过，到达瓣叶与心壁之间并绕所述根部转动，能避免影响原有二尖瓣瓣叶的运动，维持心脏正常供血，定位时间更充裕，有利于医生做位置调整，提高定位的准确性。
如图2a和图2b所示，所述根部132采用胶接、焊接、绕穿、夹接等方式被固定连接在所述瓣膜缝制段112与所述支撑段111的连接处(分界处)，当所述夹持件130被释放时，所述根部132位于目标患处的相邻组织瓣叶交界处。如图3a和图3b所示，在其中一个实施例中，当所述夹持件130被释放时，所述根部132(图3b中的132a和132b位置)位于患者二尖瓣的前瓣与后瓣交界位置(图3a中的A和B位置)。这样的设计使得所述侧翼131在释放过程中能更贴近患者的相邻组织瓣叶交界处，有利于所述侧翼131从患者的相邻组织瓣叶交界处穿过，到达瓣叶与心壁之间；同时所述侧翼131的远端能够抵触患者瓣环位置，配合所述支撑段111夹持患者瓣环，增强夹持效果。
如图4a-4f所示，在一个实施方式中，所述夹持件130包括两个侧翼131，所述侧翼131为对称设置，这样的设计使得所述夹持件130在被压缩在鞘管内后释放时，所述侧翼131能够对称释放，有利于夹持锚定的效果。所述夹持件130的两侧端部为弧形，这样设计的好处在于采用弧形的端部能够避免刺伤心壁组织造成出血。所述侧翼131具有单个或者多个连续的弧形构型，提供更大的夹持面积，增强夹持效果。位于所述夹持件130两侧的所述侧翼131在自由状态下连接成为闭环结构，连接手段包括夹持、焊接、缝绑等方式。 作为另一个实施例中，位于所述夹持件130的根部两侧的所述侧翼131为形状记忆合金丝绕制的一体结构。在其中一个实施例中，如图4f所示，所述夹持件130上设置有凸点133，以便于入鞘。
如图5a所示，在一个实施方式中，所述支撑段111的直径大于所述瓣膜缝制段112的直径，所述支撑段111沿其轴线向外张开成倒锥形，锥角为60-160°。在其中一个实施例中，所述锥角为135°。这样的设计能够起到自动定位和支撑的作用，即，当带瓣膜的置换支架在植入位置处释放时，所述支撑段111自动压在原心脏瓣膜瓣环上从而承担自动定位的功能，并且能够在置换支架释放后提供支撑作用，避免置换支架脱落进入心室。如图5b-d所示，在其中一个实施例中，所述支撑段111的外表面被部分覆膜140，或者所述瓣膜缝制段112的外表面被部分覆膜140，或者两者均被部分覆膜140，所述膜140的材料包括聚四氟乙烯、聚乙烯、聚丙烯、聚氨酯、硅胶等，以有效防止瓣周漏。
如图6a-d所示，在一个实施方式中，在所述瓣膜缝制段112的远端部分上设置有孔1120，所述根部132绕穿在所述的孔1120中。图6a为双孔，所述孔1120的直径比所述根部132的直径略大；如图6b所示，在所述瓣膜缝制段112的远端部分上设置有上下左右并排的四个孔，这样的设计是为了提高所述根部132与所述瓣膜缝制段112的连接强度，防止所述根部132在所述孔1120中打转；如图6c所示，在所述瓣膜缝制段112的远端部分上设置有左右并排，但上下错位的四个孔，这样的设计同样是为了防止所述根部132在所述孔1120中打转；如图6d所示，在所述瓣膜缝制段112的远端部分上设置有上下两个非圆孔1121，所述根部132的两根镍钛合金丝绕穿所述的非圆孔1121中。如图6e所示，在所述瓣膜缝制段112的远端部分上设置有非圆孔1121和两个圆孔1120，组成所述根部132的两根镍钛合金丝分别绕穿所述的非圆孔1121和圆孔1120。如图6f所示，在另一个实施方式中，在所述瓣膜缝制段112的远端部分上设置有缺口1122，所述根部132骑跨在所述缺口1122处，并在所述缺口1122外表面套接金属夹套1123。这样的设计能够使所述根部132与所述瓣膜缝制段112的远端部分连接牢固，能够承受由于所述侧翼绕所述根部132转动而带来的扭矩。如图6g所示，所述金属夹套1123的外表面设置有切缝1124，所述切缝1124的宽度适应所述根部132的直径，这样的设计能够防止所述根部132从所述缺口1122滑脱。如图6h所示，在其中一个实施例中，在所述瓣膜缝制段112的远端部分上设置有缺口1122，所述根部132骑跨在所述缺口1122处并绕穿在所述的孔1121中。
如图7a和图7b所示，在一个实施方式中，当同一个所述夹持件130仅包括单个侧翼131时，所述侧翼131具有单个或者多个连续的弧形构型，所述夹持件130的一侧端部为弧形。如图7c所示，不同的所述夹持件130中的所述侧翼(131a和131b)在自由状态下 沿所述瓣膜缝制段的外表面展开的长度不相等(L1≠L2)。这样的设计使得不同的侧翼夹持的宽度能够随着被夹持的瓣叶而作调整，例如二尖瓣后瓣在轴向展开的长度比二尖瓣前瓣长，因此夹持后瓣的侧翼比夹持前瓣的侧翼长能够增大夹持面积，增强夹持效果。如图7d-f所示，作为另一个实施方式，所述夹持件130a和130b各自包含一个侧翼131a和131b，所述根部132a和132b被固定在所述瓣膜缝制段与所述支撑段的连接处，当所述夹持件130a和130b被释放时，所述根部132a和132b位于目标患处的相邻组织瓣叶交界处。在其中一个实施例中，当所述夹持件130a和130b被释放时，所述根部132a和132b位于患者二尖瓣的前瓣与后瓣交界位置。这样的设计能够单独控制所述侧翼131a和131b的装载和释放。
如图8a-8e所示，为实现上述技术方案，本申请还提供了一种支架瓣膜假体的输送***160，所述输送***包括支架瓣膜假体、外鞘161、支架鞘162、支架鞘芯163和夹持件鞘164，所述支架瓣膜假体包括支架、瓣叶(未显示)和夹持件130，所述支架包括支撑段111和瓣膜缝制段112，所述支架鞘162与所述夹持件鞘164位于所述外鞘161内，所述夹持件鞘164位于所述支架鞘162外，所述瓣膜缝制段112被压缩后位于所述支架鞘162的远端部分内，所述支撑段111被压缩后位于所述外鞘161的远端部分内，所述瓣膜缝制段112的近端与所述支架鞘芯163的远端连接，所述支架鞘芯163位于所述支架鞘162内，所述夹持件130被压缩后位于所述夹持件鞘164的远端部分内，所述外鞘161的近端固定连接在外鞘操作件1610上，所述支架鞘162的近端固定连接在支架鞘操作件1620上，所述支架鞘芯163的近端固定连接在支架鞘芯操作件1630上，所述夹持件鞘164的近端固定连接在夹持件鞘操作件1640上。
所述夹持件130从压缩到完全释放依次具有三个形态，第一形态为所述夹持件130压缩在所述夹持件鞘164内，第二形态为所述夹持件130的侧翼131沿所述瓣膜缝制段112径向方向位移，穿过患者的相邻组织瓣叶交界处，到达瓣叶与心壁之间，第三形态为所述侧翼131绕其根部132转动并贴靠所述瓣膜缝制段112的外表面。
为了确保所述夹持件130能从所述夹持件鞘164中释放，在其中一个实施例中，在所述夹持件鞘164中还设置有夹持件鞘芯165，所述夹持件鞘芯165的远端与所述夹持件130接触，所述夹持件鞘芯165的近端固定连接在夹持件鞘芯操作件1650上。本申请所述夹持件鞘164的远端和所述夹持件鞘芯165的远端皆为柔性，其目的在于使得所述夹持件鞘164以及所述夹持件鞘芯165能够顺应所述夹持件130的变形。当所述夹持件130部分露出所述夹持件鞘164时，整体推动所述夹持件鞘164及所述夹持件鞘芯165使得所述夹持件130露出部分往心室壁方向拱起，所述侧翼131从患者的相邻组织瓣叶交界处穿过，到 达瓣叶与心壁之间；此过程可逆，整体拉动所述夹持件鞘164及所述夹持件鞘芯165可让所述夹持件130露出部分恢复为非拱起的状态，使得医生可多次调整定位，提高定位效果。在其中一个实施例中，当所述夹持件130需要被压缩进入所述夹持件鞘164时，所述侧翼131沿所述根部132往与展开方向相反的方向压缩后拉直进入所述夹持件鞘164。区别于普通的拉直入鞘处理，这样的设计让所述侧翼131全部露出所述夹持件鞘164时能够沿所述瓣膜缝制段112的周向展开为弧形结构，提高夹持力度。
如图9a-9e所示，在一个实施方式中，所述夹持件鞘164的截面为非圆形，相比于圆形截面，非圆形截面能够充分利用空间，减少鞘管尺寸。在另一个实施例中，本申请中所述输送***160还包括夹持件导引丝166，所述夹持件导引丝166位于所述夹持件鞘芯165内，所述夹持件导引丝166的近端固定连接在夹持件导引丝操作件1660上。所述侧翼131沿所述根部132往与展开方向相反的方向压缩后形成缝隙1310，当所述夹持件130处于第一形态时，所述夹持件导引丝166的远端从所述缝隙1310中穿过，这样的设计能够确保所述侧翼131在所述夹持件导引丝166从所述缝隙1310中抽离时方能完全打开，避免所述侧翼131在从所述夹持件鞘164释放时过早地沿所述瓣膜缝制段112的周向展开，确保释放完毕后患者的组织瓣叶以及临近腱索被夹持在所述侧翼131和所述瓣膜缝制段112之间。
以下将逐步说明本申请中所述支架瓣膜假体的输送***160的操作过程：
(1)如图10a-10c所示，提供所述支架瓣膜假体的输送***160，所述输送***包括支架瓣膜假体、外鞘161、支架鞘162、支架鞘芯163和夹持件鞘164，所述支架瓣膜假体100包括支架、瓣叶(未显示)和夹持件，所述支架包括支撑段111和瓣膜缝制段112，每个所述夹持件包括单个或者两个侧翼131，所述侧翼131具有与所述支架110纵轴线平行的根部132，所述侧翼131能够绕所述根部132转动，所述夹持件通过所述根部132固定连接在所述瓣膜缝制段112远端部分的外表面。
所述夹持件的所述侧翼131沿所述根部132往与展开方向相反的方向压缩后，被预装在所述夹持件鞘164内，呈第一形态(指所述夹持件被压缩在管腔内的状态)，所述夹持件导引丝166的远端从所述侧翼131因压缩而形成的所述缝隙1310中穿过；将所述瓣膜缝制段112压缩后收入所述支架鞘162内；然后将被压缩的所述撑开段111、所述夹持件鞘164连同所述支架鞘162一起收入所述外鞘161内。所述外鞘161的远端经心尖进入至患者二尖瓣处。
(2)如图11a-11c所示，将所述支架瓣膜假体输送到患者目标部位，操作所述外鞘操作件1610使得所述外鞘161沿轴向往近端滑动直至所述撑开段111被释放展开；调节所述 撑开段111的位置，使之放置在在患者瓣环以上并抵靠心房组织。
(3)如图12a-12c所示，操作所述夹持件鞘操作件1640使得所述夹持件鞘164沿轴向往近端滑动直至所述夹持件被释放一半，这时由于所述夹持件导引丝166的限制，所述侧翼131未能完成展开；调整所述根部132的位置使得所述根部132贴近患者的相邻组织瓣叶交界处。
(4)如图13a-13c所示，整体推动所述夹持件鞘操作件1640、所述夹持件鞘芯操作件1650和所述夹持件导引丝操作件1660，使得心脏内的所述夹持件130从所述第一形态转化为第二形态(指所述夹持件130沿所述瓣膜缝制段径向方向拱起，穿过患者的相邻组织瓣叶交界处，到达瓣叶与心壁之间)；同时此过程可逆，整体拉动所述夹持件鞘操作件1640、所述夹持件鞘芯操作件1650和所述夹持件导引丝操作件1660可使所述夹持件130露出部分恢复为非拱起的状态，医生可多次调整定位，提高定位准确性。本申请所述侧翼131在所述瓣膜缝制段112释放之前释放，这样设计的好处在于，通过所述侧翼131进行定位的同时，避免所述瓣膜缝制段112部分打开压迫天然瓣叶而导致出现天然瓣叶已经失效同时人工瓣叶未能工作的瓣叶功能失效时间，影响患者正常心脏供血功能。
(5)如图14a-14c所示，操作所述夹持件鞘操作件1640，使得所述夹持件鞘164相对所述夹持件鞘芯165往近端滑动，直至所述夹持件130脱出所述夹持件鞘164。操作所述夹持件导引丝操作件1660，使得所述导引丝166相对所述夹持件鞘芯165往近端滑动实现所述夹持件130的逐步释放。由于所述夹持件130具有形状记忆性，当所述导引丝166逐步脱离所述夹持件130时，所述侧翼131绕所述根部132转动，所述夹持件130从所述第二形态转化为第三形态(指所述侧翼131绕所述根部132转动并贴靠所述瓣膜缝制段112的外表面)，这时患者的组织瓣叶以及临近腱索被夹持在所述侧翼131和所述瓣膜缝制段112之间。
(6)如图15a-15c所示，操作所述支架鞘操作件1620，使得所述支架鞘沿轴向往近端滑动，使得所述瓣膜缝制段112被完全释放，患者的组织瓣叶以及临近腱索被夹紧在所述侧翼131和所述瓣膜缝制段112之间。
(7)操作所述外鞘操作件1610使得所述外鞘161沿轴向往远端滑动直至所述外鞘161的远端触碰导引头，然后所述输送***160从心尖撤离人体。
具体实施例二：
为了提高定位和锚定的效果，如图16a和图16b所示，本申请提供了一种支架瓣膜假体200，包括支架210、瓣叶(未显示)和夹持件230，所述支架210包括支撑段211和瓣膜缝制段212，所述支撑段211的近端与所述瓣膜缝制段212的远端连接，所述的瓣叶连 接在所述瓣膜缝制段212上，所述支撑段211释放后被放置在患者瓣环以上并抵靠心房组织，所述支架瓣膜假体200包括两个夹持件230，所述夹持件230由形状记忆合金丝绕制而成，或者所述夹持件230由形状记忆合金管材切割并定形而成。
所述夹持件230包括两个侧翼231a和231b，所述侧翼231具有与所述支架210纵轴线平行的根部232且能够绕所述根部232转动，所述根部232采用胶接、焊接、绕穿、夹持等方式固定连接在所述瓣膜缝制段212远端部分的外表面，所述夹持件230通过所述根部232固定连接在所述瓣膜缝制段212的外表面。在释放的过程中所述侧翼231沿所述瓣膜缝制段212径向方向位移。穿过患者的相邻组织瓣叶交界处，到达瓣叶与心壁之间，继而绕所述根部232转动并贴靠所述瓣膜缝制段212的外表面。所述侧翼231为弧形结构，所述侧翼231在自然状态下沿所述瓣膜缝制段212的外表面展开，所述侧翼231释放完毕后患者的组织瓣叶以及临近腱索被夹持在所述侧翼231和所述瓣膜缝制段212之间。在其中一个实施例中，位于所述夹持件230的根部232两侧的所述侧翼231在自由状态下为开环结构。这样设计的好处在于避免两侧的所述侧翼131同时进入一根鞘管造成鞘管尺寸增大。在其中一个实施例中，所述夹持件230两侧的所述侧翼231为形状记忆合金丝绕制的一体结构，或者位于所述夹持件230两侧的所述侧翼231由形状记忆合金管一体切割而成。
如图17a-17c所示，为实现上述技术方案，本申请还提供了一种支架瓣膜假体的输送***260，所述输送***260包括支架瓣膜假体、外鞘261、支架鞘262、支架鞘芯263和夹持件鞘264，所述支架瓣膜假体包括支架、瓣叶(未显示)和夹持件230，所述支架包括支撑段211和瓣膜缝制段212，所述支架鞘262与所述夹持件鞘264位于所述外鞘261内，所述夹持件鞘264位于所述支架鞘262外侧，所述夹持件鞘264的远端为柔性，所述瓣膜缝制段212被压缩后位于所述支架鞘262的远端部分内，所述支撑段211被压缩后位于所述外鞘261的远端部分内，所述瓣膜缝制段212的近端抵触所述支架鞘芯263的远端，所述支架鞘芯263位于所述支架鞘262内，所述夹持件230被压缩后位于所述夹持件鞘264的远端部分内，所述外鞘261的近端固定连接在外鞘操作件2610上，所述支架鞘262的近端固定连接在支架鞘操作件2620上，所述支架鞘芯263的近端固定连接在支架鞘芯操作件2630上，所述夹持件鞘264的近端固定连接在夹持件鞘操作件2640上。
所述夹持件230两侧的所述侧翼231a和231b分别被压缩装载在两个所述夹持件鞘264a和264b中。如图17d所示，在一个实施方式中，所述夹持件鞘264的远端部分设置有切缝2642。所述切缝2642具有方向性，使得所述夹持件鞘264的远端部分具有至少两个折弯，所述夹持件鞘264的远端部分能顺应所述折弯进行柔性弯曲。所述夹持件鞘264中还设置有夹持件鞘芯265，所述夹持件鞘芯265的远端为柔性，所述夹持件鞘芯265的 远端与所述夹持件230抵接，所述夹持件鞘芯265的近端固定连接在夹持件鞘芯操作件2650上。
本申请所述夹持件鞘264的远端和所述夹持件鞘芯265的远端皆为柔性，操作位于患者体外的手柄使得所述夹持件鞘264往心室壁方向拱起，所述夹持件鞘264连同位于其中的所述侧翼231从患者的相邻组织瓣叶交界处径向拱起，到达瓣叶与心壁之间；此过程可逆，操作患者体外的手柄，例如使得所述夹持件鞘264恢复为非拱起的状态，使得医生可多次调整定位，提高定位效果。定位完成后，操作患者体外的手柄使得所述夹持件鞘264连同位于其中的所述侧翼231绕所述根部232转动，这时患者的组织瓣叶以及临近腱索被夹持在所述夹持件鞘264和所述瓣膜缝制段212之间。最后相对所述夹持件鞘芯265后撤所述夹持件鞘264，所述侧翼231逐步释放，所述侧翼231释放完毕后，患者的组织瓣叶以及临近腱索被夹持在所述侧翼231和所述瓣膜缝制段212之间。
以下将逐步说明本申请中所述支架瓣膜假体的输送***260的操作过程：
(1)如图18a-18c所示，提供所述支架瓣膜假体的输送***260，所述输送***包括支架瓣膜假体、外鞘261、支架鞘262、支架鞘芯263和夹持件鞘264，所述支架瓣膜假体包括支架，瓣叶(未显示)和夹持件，所述支架包括支撑段211和瓣膜缝制段212，每个所述夹持件包括单个或者两个侧翼231，所述侧翼231具有与所述支架210纵轴线平行的根部232，所述侧翼231能够绕所述根部232转动，所述夹持件通过所述根部232固定连接在所述瓣膜缝制段212远端部分的外表面。
所述夹持件的所述侧翼231沿所述根部232往与展开方向相反的方向压缩后，被预装在所述夹持件鞘264内，呈第一形态(指所述夹持件被压缩在管腔内的状态)；将所述瓣膜缝制段212压缩后收入所述支架鞘262内；然后将被压缩的所述撑开段211、所述夹持件鞘264连同所述支架鞘262一起收入所述外鞘261内。所述外鞘261的远端经心尖进入至患者二尖瓣处。
(2)如图19a-19c所示，将所述支架瓣膜假体输送到患者目标部位，操作所述外鞘操作件2610使得所述外鞘261沿轴向往近端滑动直至所述撑开段211被释放展开；调节所述撑开段211的位置，使之放置在在患者瓣环以上并抵靠心房组织；操作所述支架鞘操作件2620使得所述支架鞘262沿轴向滑动直至所述瓣膜缝制段212被部分释放。
(3)如图20a-20c所示，调整所述根部232的位置使得所述根部232贴近患者的相邻组织瓣叶交界处，整体推动所述夹持件鞘操作件2640和所述夹持件鞘芯操作件2650，使得心脏内的所述夹持件鞘264连同其中的所述侧翼231沿所述瓣膜缝制段212径向拱起，并从患者的相邻组织瓣叶交界处穿过，到达瓣叶与心壁之间，此时所述夹持件从所述第一 形态转化为第二形态；此过程可逆，整体拉动所述夹持件鞘操作件2640和所述夹持件鞘芯操作件2650可使所述夹持件鞘264恢复为非拱起的状态，医生可多次调整定位，提高定位准确性。
(4)如图21a-21c所示，旋转所述夹持件鞘操作件2640，使得所述夹持件鞘264连同位于其中的所述侧翼231绕所述根部232转动，所述夹持件230从所述第二形态转化为第三形态(指所述侧翼231绕所述根部232转动并贴靠所述瓣膜缝制段212的外表面)，这时患者的组织瓣叶以及临近腱索被夹持在所述夹持件鞘264和所述瓣膜缝制段212之间。
(5)如图22a-22c所示，操作所述夹持件鞘操作件2640，使得所述夹持件鞘264相对于所述夹持件鞘芯(未显示)往近端滑动，所述夹持件230被完全释放，这时患者的组织瓣叶以及临近腱索被夹持在所述夹持件230和所述瓣膜缝制段212之间。
(6)如图23a-23c所示，操作所述支架鞘操作件2620，使得所述支架鞘(未显示)相对于所述支架鞘芯(未显示)往近端滑动，所述瓣膜缝制段212被完全释放，这时患者的组织瓣叶以及临近腱索被夹紧在所述夹持件230和所述瓣膜缝制段212之间。
(7)操作所述外鞘操作件2610使得所述外鞘261沿轴向往远端滑动直至所述外鞘261的远端触碰导引头，然后所述输送***260从心尖撤离人体。
具体实施例三：
本申请所述的支架瓣膜假体300还可以应用在三尖瓣置换领域。如图24a和图24b所示，三尖瓣结构020由三尖瓣瓣环021、隔瓣022、前瓣023、后瓣024、腱索025、***肌026、右心房027和右心室028构成的整体。如图24c和图24d所示，在一个实施方式中，所述的支架瓣膜假体300包括三个夹持件330，每个所述的夹持件330包括两个侧翼331，所述侧翼331具有与所述支架310纵轴线平行的根部332，所述夹持件330通过所述根部332固定连接在所述瓣膜缝制段312远端部分的外表面，所述侧翼331能够绕所述根部332转动。当所述夹持件310被释放时，所述根部332位于患者三尖瓣的前瓣023与隔瓣022交界位置、或者所述根部332位于患者三尖瓣的前瓣023与后瓣024交界位置、或者所述根部332位于患者三尖瓣的后瓣024与隔瓣022交界位置。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对申请专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范 围。因此，本申请专利的保护范围应以所附权利要求为准。

Claims (15)

  1. 一种支架瓣膜假体，其特征在于，包括支架、瓣叶和夹持件，所述支架包括支撑段和瓣膜缝制段，所述支撑段的近端与所述瓣膜缝制段的远端连接，所述瓣叶被连接在所述瓣膜缝制段上，所述支撑段释放后能够被放置在患者瓣环上并抵靠心房组织，所述夹持件包括一个或者多个侧翼，所述夹持件的一端被固定连接在所述瓣膜缝制段的外表面，所述夹持件从压缩到完全释放依次具有三个形态，第一形态为所述侧翼被压缩在控制装置内；第二形态为所述侧翼沿所述瓣膜缝制段径向方向伸展，能够穿过相邻组织的瓣叶交界处到达瓣叶与心壁之间；第三形态为所述侧翼沿所述瓣膜缝制段周向伸展并贴靠所述瓣膜缝制段的外表面。
  2. 根据权利要求1所述的支架瓣膜假体，其特征在于，所述侧翼具有根部，所述夹持件通过所述根部固定连接在所述瓣膜缝制段的外表面。
  3. 根据权利要求2所述的支架瓣膜假体，其特征在于，所述侧翼能够绕所述根部转动。
  4. 根据权利要求2所述的支架瓣膜假体，其特征在于，所述根部与所述支架纵轴线平行。
  5. 根据权利要求2所述的支架瓣膜假体，其特征在于，所述根部被设置在所述瓣膜缝制段的远端部分上，或者所述根部被固定在所述瓣膜缝制段与所述支撑段的连接处。
  6. 根据权利要求1所述的支架瓣膜假体，其特征在于，所述侧翼为弧形结构，所述侧翼在自然状态下沿所述瓣膜缝制段的外表面周向展开。
  7. 根据权利要求1所述的支架瓣膜假体，其特征在于，所述侧翼在所述瓣膜缝制段被释放之前释放。
  8. 根据权利要求1所述的支架瓣膜假体，其特征在于，所述夹持件为多个。
  9. 根据权利要求8所述的支架瓣膜假体，其特征在于，当同一个所述夹持件包括偶数个侧翼时，所述侧翼为对称设置。
  10. 根据权利要求1所述的支架瓣膜假体，其特征在于，每个所述侧翼具有单个或者多个连续的弧形构型。
  11. 一种根据权利要求1至10所述的支架瓣膜假体的输送***，其特征在于，所述输送***包括所述支架瓣膜假体、外鞘、支架鞘、支架鞘芯和夹持件鞘，所述支架鞘与所述夹持件鞘被设置在所述外鞘内，所述夹持件鞘位于所述支架鞘外，所述瓣膜缝制段被压缩后位于所述支架鞘的远端部分内，所述支撑段被压缩后位于所述外鞘的远端部分内，所 述瓣膜缝制段的近端与所述支架鞘芯的远端连接，所述支架鞘芯被设置在所述支架鞘内，所述夹持件被压缩后位于所述夹持件鞘的远端部分内，所述外鞘的近端固定连接在外鞘操作件上，所述支架鞘的近端固定连接在支架鞘操作件上，所述支架鞘芯的近端固定连接在支架鞘芯操作件上，所述夹持件鞘的近端固定连接在夹持件鞘操作件上。
  12. 根据权利要求11所述的支架瓣膜假体的输送***，其特征在于，在所述夹持件鞘中还设置有夹持件鞘芯，所述夹持件鞘的远端和所述夹持件鞘芯的远端皆为柔性，所述夹持件鞘芯的远端与所述夹持件接触，所述夹持件鞘芯的近端固定连接在夹持件鞘芯操作件上。
  13. 根据权利要求11所述的支架瓣膜假体的输送***，其特征在于，当所述夹持件需要被压缩进入所述夹持件鞘时，所述夹持件以与展开方向相反的方向被拉直压缩在所述夹持件鞘内。
  14. 根据权利要求11所述的支架瓣膜假体的输送***，其特征在于，所述输送***还包括夹持件导引丝，所述夹持件导引丝位于所述夹持件鞘芯内，所述侧翼沿所述根部往与展开方向相反的方向压缩后形成缝隙，当所述夹持件处于第一形态时，所述夹持件导引丝的远端从所述夹持件的缝隙中穿过，所述夹持件导引丝的近端固定连接在夹持件导引丝操作件上。
  15. 根据权利要求11所述的支架瓣膜假体的输送***，其特征在于，所述夹持件鞘的远端部分设置有切缝。
PCT/CN2019/121480 2018-12-03 2019-11-28 支架瓣膜假体及其输送*** WO2020114299A1 (zh)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112869915B (zh) * 2021-01-14 2023-05-12 上海易桥医疗器械有限公司 瓣膜假体和瓣膜假体***
CN113332000B (zh) * 2021-07-12 2024-04-26 上海臻亿医疗科技有限公司 一种支架装载***及方法
CN114652489A (zh) * 2022-03-18 2022-06-24 杭州端佑医疗科技有限公司 瓣膜修复***及其联接器械
CN117562708B (zh) * 2023-11-29 2024-06-25 启晨(上海)医疗器械有限公司 瓣膜装置用支架、瓣膜装置及输送***

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080071361A1 (en) * 2006-09-19 2008-03-20 Yosi Tuval Leaflet-sensitive valve fixation member
US20110137410A1 (en) * 2009-12-08 2011-06-09 Hacohen Gil Foldable hinged prosthetic heart valve
CN102869319A (zh) * 2010-03-11 2013-01-09 美敦力公司 窦配合固定构件
CN102958469A (zh) * 2010-02-24 2013-03-06 美敦力公司 二尖瓣假体
CN104188737A (zh) * 2009-12-04 2014-12-10 爱德华兹生命科学公司 用于替换二尖瓣的人工瓣膜
CN104274259A (zh) * 2014-10-30 2015-01-14 宁波健世生物科技有限公司 一种带瓣叶夹持装置的人工瓣膜假体
CN104902850A (zh) * 2013-01-08 2015-09-09 美敦力公司 瓣膜假体和递送方法
CN105496606A (zh) * 2016-01-11 2016-04-20 北京迈迪顶峰医疗科技有限公司 一种经导管输送主动脉瓣瓣膜装置
US20170348100A1 (en) * 2010-05-05 2017-12-07 Neovasc Tiara, Inc. Transcatheter mitral valve prosthesis
CN108366858A (zh) * 2015-11-10 2018-08-03 爱德华兹生命科学公司 用于置换天然二尖瓣的经导管心脏瓣膜

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7006940B2 (ja) * 2016-01-29 2022-01-24 ニオバスク ティアラ インコーポレイテッド 流出の閉塞を回避するための人工弁
GB201611910D0 (en) * 2016-07-08 2016-08-24 Valtech Cardio Ltd Adjustable annuloplasty device with alternating peaks and troughs

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080071361A1 (en) * 2006-09-19 2008-03-20 Yosi Tuval Leaflet-sensitive valve fixation member
CN104188737A (zh) * 2009-12-04 2014-12-10 爱德华兹生命科学公司 用于替换二尖瓣的人工瓣膜
US20110137410A1 (en) * 2009-12-08 2011-06-09 Hacohen Gil Foldable hinged prosthetic heart valve
CN102958469A (zh) * 2010-02-24 2013-03-06 美敦力公司 二尖瓣假体
CN102869319A (zh) * 2010-03-11 2013-01-09 美敦力公司 窦配合固定构件
US20170348100A1 (en) * 2010-05-05 2017-12-07 Neovasc Tiara, Inc. Transcatheter mitral valve prosthesis
CN104902850A (zh) * 2013-01-08 2015-09-09 美敦力公司 瓣膜假体和递送方法
CN104274259A (zh) * 2014-10-30 2015-01-14 宁波健世生物科技有限公司 一种带瓣叶夹持装置的人工瓣膜假体
CN108366858A (zh) * 2015-11-10 2018-08-03 爱德华兹生命科学公司 用于置换天然二尖瓣的经导管心脏瓣膜
CN105496606A (zh) * 2016-01-11 2016-04-20 北京迈迪顶峰医疗科技有限公司 一种经导管输送主动脉瓣瓣膜装置

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