WO2020192599A1 - Endoprothèse de valvule cardiaque et sa prothèse - Google Patents

Endoprothèse de valvule cardiaque et sa prothèse Download PDF

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Publication number
WO2020192599A1
WO2020192599A1 PCT/CN2020/080529 CN2020080529W WO2020192599A1 WO 2020192599 A1 WO2020192599 A1 WO 2020192599A1 CN 2020080529 W CN2020080529 W CN 2020080529W WO 2020192599 A1 WO2020192599 A1 WO 2020192599A1
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WO
WIPO (PCT)
Prior art keywords
ear
grab
heart valve
stent
grasping
Prior art date
Application number
PCT/CN2020/080529
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English (en)
Chinese (zh)
Inventor
石若璘
阳明
陈国明
李�雨
Original Assignee
上海微创心通医疗科技有限公司
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Application filed by 上海微创心通医疗科技有限公司 filed Critical 上海微创心通医疗科技有限公司
Publication of WO2020192599A1 publication Critical patent/WO2020192599A1/fr

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Classifications

    • 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • A61F2/2457—Chordae tendineae prostheses
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor

Definitions

  • the invention relates to an interventional medical device, in particular to a heart valve stent and its prosthesis.
  • the heart contains four heart chambers, the left atrium and left ventricle are on the left side of the heart, and the right atrium and right ventricle are on the right side of the heart.
  • the atrium and the ventricle form the ventricular inflow tract
  • the left ventricle and the aorta form the left ventricular outflow tract
  • the right ventricle and the pulmonary artery form the right ventricular outflow tract.
  • the valve has a problem, the hemodynamics of the heart changes and the heart functions abnormally, which is called valvular heart disease.
  • the mitral valve also known as the mitral valve, is located in the left ventricular inflow tract.
  • the main structure is the mitral valve complex, including the mitral valve annulus, leaflets, chordae and papillary muscles. Some documents also include the ventricular wall.
  • the mitral valve annulus is the dense connective tissue around the left atrium and ventricular orifice. Its anterior annulus is composed of part of the aortic valve in the left ventricular outflow tract without coronary annulus, part of the left coronary annulus, and left and right fiber triangles. , The posterior annulus is the attachment of the posterior leaflet.
  • the anterior mitral valve leaflet is the fiber extension of the aortic valve, which forms the left ventricular inflow tract with the posterior valve leaflet, and forms the left ventricular outflow tract corresponding to the cardiac septum.
  • the chordae of the mitral valve as a supporting device connecting the mitral valve leaflets and the myocardium, is distributed between the valve leaflets and the myocardium.
  • the subvalvular structure of the mitral valve plays an important role in maintaining the structure and function of the left heart.
  • the tricuspid valve is the atrioventricular valve of the right heart. Its structure is similar to that of the mitral valve. It also contains leaflets, annulus, chordae, papillary muscles and myocardium. Therefore, the heart valve prosthesis structure that replaces the native mitral valve can also be used to replace the native tricuspid valve, and the size of the prosthetic valve varies according to the size of the native valve.
  • the original annulus of the mitral valve has a larger diameter, and accordingly, the leaflet area of the artificial valve is also larger.
  • the larger the leaflet area the worse the fatigue resistance of the valve prosthesis.
  • the area of the valve leaflet is large, the size of the stent required is correspondingly large, and the diameter of the catheter used to deliver the valve prosthesis will also be large, which increases the difficulty of delivery and the risk of vascular damage.
  • the structure of the atrioventricular valve assembly is complicated. If the height of the prosthetic valve is too high, it will affect the original heart structure and heart function, cause chordae rupture, touch papillary muscles and other heart tissue abnormalities, and easily cause left ventricular outflow tract obstruction , Induce adverse postoperative effects.
  • SAM Systolic anterior motion
  • the technical problem to be solved by the present invention is to provide a heart valve stent and its prosthesis.
  • the valve leaflet of the valve prosthesis has a small diameter, the valve has good fatigue resistance, and can reduce the difficulty of delivery and the risk of vascular damage.
  • a heart valve stent which includes a stent body, the stent body has an inflow channel and an outflow channel connected axially, and the inflow channel and the outflow channel are mutually connected Consisting of connected grid structure units, the stent body is provided with an ear grasping structure extending toward the proximal end of the inflow channel, the proximal end of the inflow channel is turned outward, and the proximal end of the ear grasping structure and the A gap is formed between the inflow channels.
  • the outer diameter of the distal end of the outflow channel is smaller than the outer diameter of the proximal end of the inflow channel.
  • the ear grab structure includes a front grab ear and a back grab ear, the front grab ear and the back grab ear are unevenly distributed along the bracket body in the circumferential direction, and the front grab ear
  • the range of the central angle distributed in the circumferential direction is 10° ⁇ 120° or/and 240°-350°; the range of the central angle distributed in the circumferential direction of the rear grasping ear is 30°-330°.
  • the ear grab structure further includes an anterior lobe grabbing ear, the central angle of the anterior lobe grabbing ear in the circumferential direction ranges from 330° to 30°; the anterior lobe grabbing ear is set toward one side of the stent body Barbed or serrated.
  • the ear grab structure is a cantilever structure with a fixed end and a free end, the fixed end of the ear grab structure is located on the outflow tract, and the free end of the ear grab structure and the inflow tract are formed between Crevice.
  • the ear grasping structure is a rod-shaped structure, the fixed end is located at the end of the outflow tract, and the free end is spherical or ellipsoidal.
  • the ear grasping structure includes a front grasping ear and a rear grasping ear, the free end of the front grasping ear is folded outward; the free end of the rear grasping ear is folded inward.
  • the ear-grasping structure and the bracket body are formed integrally; or the ear-grasping structure and the bracket body are connected by riveting, welding or snapping.
  • both ends of the ear grab structure are respectively fixed on the bracket body, and the ear grab structure and the grid structure unit of the bracket body form a closed structure.
  • the outer diameter of the proximal port of the inflow channel is 35-75mm, the rigidity of the inflow channel is greater than the rigidity of the outflow channel; the height of the outflow channel in the axial direction is 5-20mm, and the outer diameter is 21-55mm.
  • a heart valve prosthesis including a heart valve stent and a valve, the valve being fixedly arranged on the inner surface of the stent body, and the heart valve stent is The above-mentioned heart valve stent.
  • the present invention has the following beneficial effects: the heart valve stent and its prosthesis provided by the present invention replace the interference fit of the existing stent body by clamping the native valve leaflets by the ear grasping structure and the inflow tract mesh ( Oversize) anchoring method makes the main body of the outflow tract, namely the suture area of the valve leaflet, have a smaller outer diameter.
  • the anti-fatigue performance of the valve leaflet with a smaller outer diameter will be improved.
  • the diameter of the catheter adapted to the delivery system of the present invention can also be set smaller, which reduces the difficulty of delivery and the risk of vascular damage.
  • the subvalvular height of the heart valve stent required by the smaller outer diameter of the leaflet is smaller, the interference of the stent to the subvalvular tissues of the heart (such as papillary muscles, ventricular wall, etc.) is solved, and the heart function and the anti-fatigue performance of the stent are obtained improve.
  • the reduction in the axial height of the stent reduces the obstruction of the left ventricular outflow tract (LVOTO).
  • setting the anterior leaflet grasping ears can fix the free leaflets and reduce the possibility of blocking the left ventricular outflow tract due to pre-systolic leaflet movement (SAM).
  • SAM pre-systolic leaflet movement
  • the inflow flange shape fit assists the clamping of the ear-grasping structure, reducing the risk of paravalvular leakage.
  • Fig. 1 is a structural schematic diagram of the front view direction of a heart valve prosthesis in an embodiment of the present invention
  • FIG. 2 is a schematic structural view of the heart valve prosthesis in the top view direction in the embodiment of the present invention.
  • FIG. 3 is a schematic diagram of the overall structure of the heart valve stent in the embodiment of the present invention.
  • Figure 4 (a) is a schematic diagram of the circumferential distribution of the ear grasping structure on the heart valve stent in an embodiment of the present invention
  • Figure 4 (b) is a schematic diagram of the angular distribution of the ear grasping structure in the circumferential direction;
  • Figure 5 is a schematic cross-sectional view of the native valve
  • Fig. 6 is a schematic diagram of the use state of the heart valve prosthesis after implantation in the human body in the embodiment of the present invention.
  • Fig. 7 is a partial enlarged schematic diagram of A in Fig. 6.
  • the heart valve prosthesis provided in this embodiment is an artificial heart valve prosthesis implanted via a catheter, which is mainly used to replace heart valves.
  • the heart valve prosthesis provided by the present invention has the characteristics of small size and good fatigue resistance.
  • the valve prosthesis structure provided by the present invention can be matched and designed according to the original heart structure, so that the original heart valve can be completely replaced, the damage to the subvalvular structure is small, and the risk of obstruction of the outflow tract is low.
  • proximal means the end close to the operator during the operation;
  • distal means the end away from the operator;
  • outward means the direction away from the central axis of the stent body;
  • inward means the direction close to the central axis of the stent body.
  • the term “or” is usually used in the meaning including “and/or”, unless the content clearly indicates otherwise.
  • the heart valve prosthesis 1 includes a heart valve stent, a skirt 20, and a valve 30.
  • the heart valve stent includes a stent body 10 that has an inflow channel 101 and an outflow channel 102 that are axially connected. The outflow channel 102 is based on the direction of blood flow.
  • the inflow channel 101 corresponds to the part where blood flows into the heart valve prosthesis during valve operation
  • the outflow channel 102 corresponds to the part where blood flows out of the heart valve prosthesis during valve operation.
  • the stent body 10 is composed of structural units whose axial shape can be changed, such as grid-like structural units or wave-shaped structural units.
  • the axial direction is composed of at least one row of structural units connected to each other in the circumferential direction, and there are multiple rows of units in the axial direction. They can be connected directly or indirectly to each other.
  • the grid-like structural unit is a triangular, rhombic, pentagonal, hexagonal, drop-shaped structural unit that can form a closed shape.
  • the stent body 10 is provided with a grabbing ear structure for anchoring and a hanging ear 106 for matching with the conveying system.
  • the grabbing structure is divided into a front side grabbing ear 103, a back side grabbing ear 104 and a front lobe grabbing ear 105 according to the structure and function.
  • the ear catching structure is arranged on the stent body 10 and extends outward toward the proximal end 101A of the inflow channel, preferably from the end of the outflow channel 102 toward the proximal end 101A of the inflow channel.
  • the hanging ear 106 is located on the end of the inflow channel 101 or/and the end of the outflow channel 102, except for the end of the outflow channel occupied by the ear grasping structure.
  • the inflow channel 101 is outward in shape, that is, the port of the inflow channel 101 is turned outward, and its maximum outer diameter is larger than the annulus diameter of the native valve, preferably 35-75 mm, and its rigidity is higher than that of the outflow channel 102.
  • the effect of this arrangement is that at least a part of the inflow channel 101 can be located above the annulus of the native valve to form an inflow channel flange 1011 whose outer contour fits the anatomy of the annulus and atrial wall.
  • the inflow channel flange 1011 is sutured
  • the skirt 20 can prevent paravalvular leakage.
  • a gap is formed between the inflow flange 1011 and the proximal end of the ear grasping structure, which can clamp the myocardial wall or the native valve leaflet for anchoring.
  • the cross-section of the main body of the inflow channel 101 can be circular, D-shaped or elliptical, and has an annulus shape that matches the mitral valve, preferably D-shaped or elliptical.
  • a skirt 20 is sutured on the stent inflow channel 101 to prevent paravalvular leakage.
  • the stent outflow tract 102 is located on the hemodynamic outflow tract side of the native valve.
  • the outer diameter of the distal end 102B of the outflow tract is smaller than the outer diameter of the proximal end 101A of the inflow tract.
  • the height of the stent outflow channel 102 in the axial direction is preferably 5-20 mm, and its outer diameter is preferably 21-55 mm.
  • the body of the outflow tract 102 is composed of a closed grid structure unit, which provides attachment points for the valve leaflets, but does not provide support for the stent.
  • this embodiment compared with the existing outflow tract structure that provides support for the stent, this embodiment
  • the outer diameter of the outflow channel 102 is smaller, and the smaller outer diameter of the outflow channel reduces the diameter of the valve leaflet, which correspondingly improves the fatigue resistance of the valve leaflet, while reducing the axial height of the outflow channel 102, subvalvular interference and left ventricle
  • LVOTO outflow tract obstruction
  • the ear grab structure is divided into the front side grab ear 103, the front lobe grab ear 105 and the back side grab ear 104.
  • the front lobe grab ear 105 can be selected according to needs.
  • the ear grasping structure is unevenly distributed in the circumferential direction.
  • the angle of distribution the present invention has no special restrictions. It needs to be adapted according to the anatomical structure of the human body.
  • Figure 4(a) only shows one of the embodiments.
  • Figure 4(b) is a schematic diagram of the angular distribution of the ear-grasping structure in the circumferential direction. Please refer to Figure 4(b), where the radius of the ray is used as the starting edge of the central angle.
  • the front side ear-grasping 103 The angle of the central angle distributed in the circumferential direction is 10° ⁇ 120°, preferably 30° ⁇ 50°; or/and 240° ⁇ 350°, preferably 260° ⁇ 280°; can be set on one side or/and both sides of the bracket ; Preferably on both sides.
  • the central angle of the rear grasping ear 104 in the circumferential direction is 30° ⁇ 330°, preferably 100° ⁇ 260°.
  • the central angle of the anterior lobe grasping ear 105 in the circumferential direction is 330°-30°, preferably 350°-10°. There are no special restrictions on the number of the three.
  • the front grasping ear 103 extends from the stent body 10, preferably from the middle part of the cell grid on the outflow tract 102 or the end of the outflow tract 102 to extend outward toward the proximal end 101A of the inflow tract;
  • the front gripping ear 103 has a fixed end 103A and a free end 103B, and the free end 103B is away from the bracket body 10 and the fixed end 103A, and faces the inflow channel 101 direction.
  • the height of the front gripping ear 103 in the axial direction is adjusted according to the height of the outflow channel 102 in the axial direction to match the shape of the inflow channel 101.
  • the specific value is not specified in the present invention, and is generally 0-10mm.
  • the clamping position of the front grasping ear 103 is preferably the front lateral commissure (CL) region and the posterior medial commissure (CM) region shown in FIG. 5.
  • the anchoring site of the posterior grasping ear 104 is the P area of the posterior mitral valve leaflet in FIG. 5, that is, within the range of P1, P2L, P2M, and P3.
  • the anchoring method is the posterior grasping ear 104 It cooperates with the inflow flange 1011 to form a clamping force.
  • Figures 6 and 7. After the rear grasping ear 104 is attached to the myocardial wall 21, a clamping force is formed between the inflow flange 1011 and the corresponding flap is clamped. Ring structure (Myocardial shelf).
  • the clamping and anchoring force provided by the combination of the anterior grasping ear 103 and the posterior grasping ear 104 reduces the radial support force required by the heart valve prosthesis at the native valve annulus, and reduces the risk of tearing the native valve annulus.
  • the valve prosthesis can have a smaller diameter, which improves the fatigue resistance of the valve prosthesis.
  • the front leaf grasping ear 105 is mainly used to limit the native valve leaflet, and it can be set or not set as needed. Please refer to FIG. 5, the anterior leaf grasping ear 105 is located in the area A2 (ie, A2L and A2M) of the anterior leaflet A of the mitral valve. The anterior leaf grasping ear 105 has a limiting effect on the native valve leaflets. The original leaflet is sandwiched between the anterior leaf grasping ear 105 and the inflow flange 1011.
  • the anterior leaf grasping ear 105 and the native valve leaflet fitting position (that is, the position where the inflow flange 1011 needs to be clamped together) has a certain degree of roughness. If barbed or serrated, the anterior leaflet The friction force between the cantilever structure of the grab ear 105 and the valve leaflet improves the anchoring stability.
  • the ear-grasping structure and the bracket body 10 can be integrally processed, or they can be connected by any means such as riveting, welding, snapping, etc., which can be connected stably.
  • the ear grasping structure is a cantilever structure, and the gap between the free end of the cantilever and the inflow flange 1011 is selected according to the anatomical dimensions of the annulus and the myocardial wall to provide the pre-tightening force required to clamp the myocardial wall 21.
  • the cantilever has strong rigidity to ensure that it will not deform and cause falling off when clamping the myocardial wall 21.
  • strong rigidity means that the cantilever does not deform or fall off, and there is no specific numerical limit.
  • the cantilever structure is a rod-shaped structure, and the fixed point between each cantilever structure and the stent body 10 is one position, and the fixed point is located on the grid of the outflow channel 102 or the end of the outflow channel 102, and its free end It is spherical, ellipsoidal and other shapes without obvious edges and corners.
  • the free end 103B of the anterior grasping ear 103 outwards, as shown in FIGS. 3 and 5, to facilitate the fitting of the inflow flange 1011 on the anterolateral commissure CL area of the mitral valve outside L and the mitral valve inside M
  • the posterior medial commissure CM region sandwiches the myocardial wall 21.
  • the free end of the posterior grasping ear 104 is facing inward, as shown in Figures 3 and 5, in order to clamp the valve prosthesis on the myocardial wall 21 in the P2 (ie P2M and P2L) area of the posterior mitral valve leaflet P to prevent damage Myocardial tissue.
  • the free end of the front leaf grasping ear 105 is outward, as shown in FIGS. 3 and 5, which facilitates the engagement of the valve leaflet in the A2 area with the inflow flange 1011.
  • the ear grab structure and the grid unit of the bracket body 10 form a closed structure.
  • the closed structure is different from the cantilever structure. Both ends of the ear grab structure are fixed on the bracket body 10 without free ends.
  • the proximal end of the closed structure cooperates with the inflow flange 1011 to provide clamping force to the myocardial wall 21.
  • the distal end of the closed structure can also provide a certain supporting force to the valve stent, reducing the size of the stent outflow tract 102.
  • the hanging ear 106 is used to match the delivery system for transporting the heart valve prosthesis to realize the loading and release of the valve prosthesis.
  • the hanging ear 106 is the structure where the valve prosthesis finally leaves the delivery system. Therefore, the hanging ear 106 is located at the end of the inflow tract 101 or/and the outflow tract 102.
  • the ear-grasping structure front-side grasping ear 103, back-side grasping ear 104, anterior leaf Grasping ear 105) except for the end of the outflow tract occupied.
  • the ears 106 can be distributed at the end of the inflow tract 101, and the outflow tract 102 is released first during the corresponding release process; the ears 106 can also be distributed in the outflow At the end of the channel 102, the inflow channel 101 is released first during the corresponding release process; the lugs 106 can also be distributed at the end of the outflow channel and the end of the inflow channel.
  • the corresponding release process is a two-way release. You can choose to release one lug first. Finally, release the mounting ears on both sides at the same time.
  • the stent body 10 is covered with a skirt 20 made of pericardium or other biocompatible polymer materials.
  • the skirt 20 cooperates with the valve 30 to form a single blood flow channel.
  • the valve 30 is arranged on the inner surface of the stent body 10.
  • the skirt 20 is sewn on the inner or outer surface of the inlet flange 1011.
  • the stent body 10 is made of a metal material that has memory characteristics (that is, has self-expansion performance) and is biocompatible, and is preferably made by cutting a nickel-titanium alloy tube.
  • the outer diameter of the metal tube is preferably 5-15 mm, and the finalized diameter can be selected according to the actual needs of the heart valve stent.
  • the heart valve prosthesis provided in this embodiment clamps the native valve leaflets through the cooperation between the ear grasping structure and the inflow tract mesh Achieve anchoring.
  • This anchoring method allows the main body of the outflow tract, namely the valve leaflet suture area, to have a smaller outer diameter, and the smaller outer diameter of the valve leaflet will improve its fatigue resistance.
  • the diameter of the catheter adapted to the delivery system of the present invention will also be improved. It can be set smaller, which reduces the difficulty of delivery and the risk of vascular damage.
  • the smaller outer diameter of the valve leaflet requires a smaller subvalvular height of the stent.
  • the interference of the stent on the subvalvular tissues of the heart is solved, and the heart function and the anti-fatigue performance of the stent are also improved.
  • the reduced axial height of the stent reduces the obstruction of the left ventricular outflow tract (LVOTO).
  • the anterior leaflet grasping ear 105 can fix the free leaflets, which reduces the possibility of blocking the left ventricular outflow tract due to the occurrence of systolic anterior leaflet movement (SAM).
  • SAM systolic anterior leaflet movement
  • the fitting shape of the inflow flange 1011 assists in clamping with the ear-grasping structure, which reduces the risk of paravalvular leakage.

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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

L'invention concerne une endoprothèse de valvule cardiaque et une prothèse (1) de celle-ci, l'endoprothèse de valvule cardiaque comprenant un corps principal (10) d'endoprothèse, le corps principal (10) d'endoprothèse comportant une voie d'entrée (101) et une voie de sortie (102) reliées axialement, la voie d'entrée (101) et la voie de sortie (102) comprenant chacune des unités de structure de maillage interconnectées ; le corps principal (10) d'endoprothèse comporte, disposée sur celui-ci, une structure de languette à griffe s'étendant dans la direction d'une extrémité proximale (101A) de la voie d'entrée (101), l'extrémité proximale (101A) de la voie d'entrée (101) se repliant vers l'extérieur, et un espace de serrage étant formé entre une extrémité proximale de la structure de languette à griffe et la voie d'entrée (101). Le diamètre de feuillet d'une prothèse de valvule cardiaque (1) est relativement petit, et une valvule (30) ayant une résistance à la fatigue relativement bonne est susceptible d'éviter ou de réduire les phénomènes d'obstruction de la voie de sortie (102) et de fuite paravalvulaire ; un diamètre de cathéter d'un système de transport adapté est relativement petit, réduisant ainsi la difficulté de transport et le risque de lésion vasculaire ; simultanément cela permet de réduire le phénomène de mouvement systolique de feuillet antérieur (SAM), réduisant ainsi le risque de blocage de la voie de sortie ventriculaire gauche.
PCT/CN2020/080529 2019-03-22 2020-03-21 Endoprothèse de valvule cardiaque et sa prothèse WO2020192599A1 (fr)

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EP4049621A4 (fr) * 2020-12-28 2023-02-08 Shanghai Trulive Medtech Co., Ltd Prothèse de valve artificielle
CN113730036A (zh) * 2021-09-30 2021-12-03 宁波健世科技股份有限公司 一种可与自体瓣叶锚定的心脏瓣膜假体
CN113730039A (zh) * 2021-10-08 2021-12-03 广东脉搏医疗科技有限公司 一种支架瓣膜
CN114028030B (zh) * 2021-11-09 2023-02-28 上海臻亿医疗科技有限公司 一种人工心脏瓣膜
CN218420135U (zh) * 2022-04-24 2023-02-03 上海微创心通医疗科技有限公司 瓣膜支架以及瓣膜假体
CN116999207A (zh) * 2022-04-29 2023-11-07 上海微创心通医疗科技有限公司 瓣膜支架、瓣膜假体以及瓣膜假体系统

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