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WO2022057799A1 - Stent de valve cardiaque artificielle, valve cardiaque artificielle et système de remplacement de valve cardiaque artificielle - Google Patents

Stent de valve cardiaque artificielle, valve cardiaque artificielle et système de remplacement de valve cardiaque artificielle Download PDF

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Publication number
WO2022057799A1
WO2022057799A1 PCT/CN2021/118344 CN2021118344W WO2022057799A1 WO 2022057799 A1 WO2022057799 A1 WO 2022057799A1 CN 2021118344 W CN2021118344 W CN 2021118344W WO 2022057799 A1 WO2022057799 A1 WO 2022057799A1
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WIPO (PCT)
Prior art keywords
stent
heart valve
artificial heart
section
inflow end
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2021/118344
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English (en)
Inventor
Tingchao ZHANG
Li Xu
Yang Li
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hangzhou Valgen Medtech Co Ltd
Original Assignee
Hangzhou Valgen Medtech Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202010971429.0A external-priority patent/CN114176833A/zh
Priority claimed from CN202022020650.6U external-priority patent/CN212662031U/zh
Application filed by Hangzhou Valgen Medtech Co Ltd filed Critical Hangzhou Valgen Medtech Co Ltd
Publication of WO2022057799A1 publication Critical patent/WO2022057799A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0029—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
    • A61F2250/0063—Nested prosthetic parts
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069—Sealing means

Definitions

  • the present disclosure generally relates to the technical field of medical devices, in particular to an artificial heart valve stent, an artificial heart valve, and an artificial heart valve replacement system.
  • a mitral valve is a one-way “valve” between a left atrium (LA) and a left ventricle (LV) , which can ensure blood flow from the left atrium to the left ventricle.
  • the mitral valve is a complex of complex functions and anatomical structures, usually including valve annulus, leaflets, chordae tendineae and papillary muscles.
  • the mitral valve When the left ventricle is in a diastolic state, the mitral valve opens and blood flows from the left atrium to the left ventricle.
  • two leaflets of a normal mitral valve When the left ventricle is in a contracted state, two leaflets of a normal mitral valve can be closely coapted or closed, which can completely block a backflow of ventricular blood flow.
  • the mitral valve annulus is of a right size, the valve leaflet structure is complete, the contraction of the papillary muscles stretches the chordae tendineae to support the valve leaflets, the closing force generated by the left ventricular muscle contraction is appropriate, and the shape and function of the left ventricle are normal.
  • Abnormalities in any of above factors may cause heart valve disease, leading to mitral regurgitation (MR: Mitral Regurgitation) .
  • interventional artificial heart valve replacement surgery has been rapidly developed and applied in clinical practice, that is, artificial heart valve is implanted into the mitral valve in-situ of the heart through minimally invasive interventional surgery to replace the damaged natural valve, achieving a satisfactory treatment effect.
  • an artificial heart valve stent comprising: an inner stent and an outer stent, wherein the inner stent comprises a first portion and a second portion in sequence from an inflow end to a outflow end along an axial direction, a radial dimension of the first portion is greater than a radial dimension of the second portion, at least a part of the second portion is nested in the outer stent, and at least a part of the first portion protrudes toward the inflow end relative to the outer stent, and the part of the first portion protruding toward the inflow end relative to the outer stent is covered with a baffle film.
  • a radial dimension of the part of the first portion protruding toward the inflow end relative to the outer stent is larger than a radial dimension at an end surface of the inflow end of the outer stent.
  • the outflow end of the outer stent is fixedly connected with the second portion, the inflow end of the outer stent hangs freely, and there is a radial gap between the inflow end of the outer stent together with a part near the inflow end of the outer stent and the second portion.
  • a range of the radial gap is from 1 mm to 18 mm.
  • a deformation resistance of the inner stent is higher than a deformation resistance of the outer stent.
  • the first portion comprises a first expansion part connected with the second portion, and a radial dimension of the first expansion part gradually increases from a connection with the second portion toward the inflow end.
  • a radial expansion angle of the first expansion part ranges from 45° to 90°.
  • the first portion further comprises a second expansion part axially connected with the first expansion part, a radial dimension of the second expansion part gradually increases from a connection with the first expansion part toward the inflow end, and a radial expansion angle of the first expansion part relative to the axial direction is greater than a radial expansion angle of the second expansion part relative to the axial direction.
  • the outer stent from the outflow end to the inflow end along the axial direction comprises a first section which is approximately funnel-shaped and a second section connected with the first section, a nozzle part of the first section is fixedly connected with the second portion, a top opening of the first section is connected with the outflow end of the second section, and the inflow end of the second section hangs freely.
  • the second section is approximately cylindrical; or a radial dimension of the second section gradually decreases from a connection with the first section towards the inflow end; or there is a depression part around a circumference near the inflow end of the second section.
  • a contraction angle of the first section ranges from 90° to 150°.
  • the outer stent further comprises at least one limit rod
  • the limit rod comprises a rod body connected with the nozzle part and a hanging end head connected to the rod body along the axial direction, and a transverse dimension of the hanging end head is larger than a transverse dimension of the rod body.
  • the outer stent further comprises at least one barb provided on the second section or/and near the inflow end of the first section, and the barb extends outward and to the inflow end simultaneously.
  • the artificial heart valve stent also comprises an imaging mechanism provided on the outer stent and/or the inner stent.
  • both the first portion and the second portion of the inner stent are covered with the baffle film.
  • the outer stent is covered with a baffle film.
  • a cross-sectional shape of the second section perpendicular to the axial direction is O-shaped or D-shaped.
  • the present disclosure relates to an artificial heart valve comprising: at least two artificial valve leaflets and an artificial heart valve stent of the present disclosure, wherein the artificial valve leaflets are fixedly connected with the inner stent in the inner stent of the artificial heart valve stent, and edges of the at least two artificial valve leaflets are coapted with each other in a circumferential direction.
  • the present disclosure relates to an artificial heart valve replacement system comprising an artificial heart valve of the present disclosure and a delivery device for delivering the artificial heart valve, wherein the artificial heart valve has a delivery state after radial compression and a natural state after radial expansion, the delivery device comprises an outer sheath and an mandrel penetrating in the outer sheath, the mandrel and the outer sheath can move relative to each other axially, the artificial heart valve which is radially compressed is received in a gap between a distal end portion of the mandrel and a distal end portion of the outer sheath.
  • the part of the inner stent that protrudes toward the inflow end relative to the outer stent is closely in touch with the atrial side of the valve annulus, the radial dimension of this part is relatively large, which can prevent the artificial heart valve stent from moving toward the ventricle, the outer stent supports the valve annulus radially and undergoes a radially inward depression deformation under the compression of the valve annulus, the outflow side of the depression deformation then forms a bulging part on the outer stent, the bulging part can prevent the artificial heart valve stent from moving toward the atrium side, so that the inner stent and the outer stent cooperate to stably position the artificial heart valve stent and the artificial heart valve in the heart and maintain the relative position of the artificial heart valve stent and the valve annulus, preventing the artificial heart valve stent from falling off from the valve annulus; and more importantly, since
  • Fig. 1 shows a schematic diagram illustrating a front view of an artificial heart valve of Example 1 of the present disclosure
  • Fig. 2 shows a structural schematic diagram illustrating the inner stent (baffle film is not shown) of Fig. 1;
  • Fig. 3 shows a structural schematic diagram illustrating the inner stent in Fig. 1 covered with a baffle film
  • Fig. 4 and Fig. 5 show a schematic diagram illustrating a front view and a perspective view of the structure of the outer stent of Fig. 1;
  • Fig. 6 shows a schematic diagram illustrating a top view of an outer stent having a second section with an O-shaped cross section
  • Fig. 7 shows a schematic diagram illustrating a top view of an outer stent having a second section with a D-shaped cross section
  • Fig. 8a to Fig. 8c show structural schematic diagrams illustrating different embodiments of a limit rod
  • Fig. 9 shows a structural schematic diagram illustrating an outer stent with a imaging mechanism
  • Fig. 10a to Fig. 10c show enlarged diagrams illustrating structures of different embodiments of the area C1 of Fig. 9;
  • Fig. 11 shows a schematic diagram illustrating a perspective structure of the artificial heart valve of Example 1 of the present disclosure
  • Fig. 12 shows a schematic diagram illustrating a perspective structure of the inner stent and the artificial valve leaflets of Fig. 11;
  • Fig. 13 shows a schematic diagram illustrating the deformed structure of the artificial heart valve of Fig. 11 when subjected to a radial force F;
  • Fig. 14 shows a schematic diagram illustrating the artificial heart valve of Fig. 11 after being implanted in the heart
  • Fig. 15 shows an enlarged view of area C2 of Fig. 14;
  • Fig. 16 shows a schematic diagram illustrating the force and deformation of the artificial heart valve of Fig. 15;
  • Fig. 17 shows a structural schematic diagram illustrating the artificial heart valve of Example 2 of the present disclosure
  • Fig. 18 shows a structural schematic diagram illustrating the inner stent of Fig. 17;
  • Fig. 19 shows a structural schematic diagram illustrating the outer stent of Fig. 17;
  • Fig. 20 shows a schematic diagram illustrating the artificial heart valve of Fig. 17 after being implanted in the heart
  • Fig. 21 shows an enlarged diagram of area C3 of Fig. 20;
  • Fig. 22 shows a further enlarged schematic diagram illustrating the artificial heart valve and valve annulus of Fig. 21;
  • Fig. 23 shows a structural schematic diagram illustrating the artificial heart valve (the baffle film and the artificial valve leaflets are not shown) of Example 3 of the present disclosure
  • Fig. 24 shows a structural schematic diagram illustrating the outer stent of Fig. 23;
  • Fig. 25 shows a structural schematic diagram of the artificial heart valve (the baffle film and the artificial valve leaflets are not shown) of Example 4 of the present disclosure
  • Fig. 26 shows a structural schematic diagram illustrating the outer stent of Fig. 25;
  • Fig. 27 shows a schematic diagram illustrating the artificial heart valve of Fig. 25 after being implanted into the valve annulus
  • Fig. 28 shows a structural schematic diagram of the artificial heart valve (the baffle film and the artificial valve leaflets are not shown) of Example 5 of the present disclosure
  • Fig. 29 shows a structural schematic diagram illustrating the outer stent of Fig. 28.
  • Fig. 30 shows a schematic diagram illustrating the artificial heart valve stent of Fig. 28 after being implanted into the valve annulus.
  • first, “second” , “third” , and the like are only for the convenience of describing the technical solutions, and cannot be understood as indicating or implying a relative importance or implicitly indicating the number of the indicated technical features, thus, the features defined by “first” , “second” , “third” , and the like may explicitly or implicitly comprise one or more of these features.
  • first, “second” , “third” , and the like may explicitly or implicitly comprise one or more of these features.
  • the inflow end/side and outflow end/side of the artificial heart valve and its components and the artificial heart valve stent and its components are defined according to the blood flow direction in the diastolic state of the ventricle.
  • the inflow end/side is the end/side that close to the blood inflow side or the atrium side
  • the outflow end/side is the end/side that close to the blood outflow side or the ventricle side.
  • the axial direction refers to the direction parallel to the line connecting the center of the outflow end and the inflow end
  • the radial direction refers to the direction perpendicular to the axial direction
  • the circumferential direction refers to the direction around the circumference.
  • the radial dimension appears frequently in the present disclosure, the radial dimension can be the maximum radial dimension or the radial dimension in the cross section passing through the central axis.
  • the method of obtaining the radial dimension is not limited, and it only needs to be assured to use the same method to obtain the radial dimension as the object of comparison.
  • the above definitions are only for the convenience of expression and cannot be understood as a limitation of the present disclosure.
  • the artificial heart valve stent 1 of Example 1 of the present disclosure comprises: an inner stent 10 and an outer stent 20, wherein the inner stent 10 comprises a first portion 101 (can also be called inner skirt) and a second portion 102 in sequence from the inflow end to the outflow end (arrow R points axially from the inflow end to the outflow end) along the axial direction (i.e., the direction of the central axis AA) , the radial dimension of the first portion 101 is greater than the radial dimension of the second portion 102, at least a part of the second portion 102 is nested in the outer stent 20, and at least a part of the first portion 101 protrudes toward the inflow end relative to the outer stent 20, and the part of the first portion 101 protruding toward the inflow end relative to the outer stent is covered with baffle film 101m.
  • the inner stent 10 comprises a first portion 101 (can also be called inner skirt) and a second portion 102 in sequence from the in
  • the artificial heart valve stent 1 of the present disclosure has a delivery state after radial compression and a natural state after radial expansion.
  • the delivery state the artificial heart valve stent 1 is radially compressed by external force, so that it can be compressed into a sheath with a relatively small radial dimension, and then delivered to the heart through a delivery device.
  • the natural state the artificial heart valve stent 1 is not affected by external force and expands naturally in the radial direction, unless otherwise specified in the following, all described are the structural features of the artificial heart valve stent 1 in the natural state.
  • the radial dimension of the portion of the first portion 101 that protrudes toward the inflow end relative to the outer stent 20 is greater than the radial dimension at the end surface of the inflow end of the outer stent 20.
  • the radial dimension of the part H of the first portion 101 protruding toward the inflow end relative to the outer stent 20 anywhere along the axis is greater than the radial dimension at the end surface of the inflow end of the outer stent 20.
  • this part of inner stent H of the first portion (or called the inner skirt) 101 protruding toward the inflow end will be laying closely in touch with the native valve annulus M on the atrium side after the artificial heart valve stent 1 is implanted in the heart.
  • the contact area between the inner skirt 101 and the native valve annulus M in the atrium can be increased by increasing the radial dimension, preventing the artificial heart valve stent 1 from moving to the ventricle side; on the other hand, this protruding part of the inner stent H is basically unaffected when the outer stent 20 is radially compressed by the valve annulus, and will not deform with the deformation of the outer stent 20, so the increased radial dimension can also enhance the sealing performance.
  • the outflow end of the outer stent 20 is fixedly connected to the second portion 102, the inflow end of the outer stent 20 hangs freely, and there is a radial gap between the inflow end of the outer stent 20 together with the part near the inflow end of the outer stent 20 and the second portion 102.
  • the above radial gap ranges from 1 mm to 18 mm. It should be noted that the value of the radial gap is only used as an example, and is not a limitation of the present disclosure, one skilled in the art can select a suitable size according to actual needs, and other sizes selected under the teaching of the present disclosure are all within the protection scope of the present disclosure.
  • the freely hanging inflow end is less restricted, so there is a larger room for deformation, which can effectively conform to the valve annulus to produce depression deformation; simultaneously, the inflow end of the outer stent 20 and its nearing part are spaced apart from the second portion 102 of the inner stent 10 in the radial direction, which provides sufficient deformation space for the deformation of the inflow end of the outer stent 20 and its nearing part.
  • the effective compliance deformation of the inflow end of the outer stent 20 and its nearing part under the radial compression of the valve annulus can provide radial support for the valve annulus, and improve the fitting performance of the artificial heart valve stent 1 and the valve annulus; more importantly, the outflow side of the depression deformation then forms a bulging part G on the outer stent 20, which can prevent the artificial heart valve stent 1 from moving toward the atrium side.
  • the first portion 101 (or called the inner skirt) of the inner stent 10 protruding toward the inflow end relative to the outer stent 20 is closely in touch with the atrial side of the valve annulus M. Due to the large radial dimension of the inner skirt 101, it can prevent the artificial heart valve stent 1 from moving toward the ventricle side.
  • the outer stent 20 radially supports the valve annulus M and undergoes a radially inward depression deformation under the compression of the valve annulus M.
  • the outflow side of the depression deformation then forms a bulging part G on the outer stent 20, which can prevent the artificial heart valve stent 1 from moving toward the atrial side, so that the inner stent 10 and the outer stent 20 cooperate to stably position the artificial heart valve stent 1 in the heart and maintain the relative position of the artificial heart valve stent 1 and the valve annulus M to prevent the artificial heart valve stent 1 from falling off from the valve annulus.
  • the inner skirt 101 is also covered with a baffle film 101m, which can effectively isolate the atrium and the ventricle, ensuring the sealing of the atrium side, and reduce the risk of paravalvular leakage.
  • the end surface of the inflow end of the outer stent 20 is spaced apart from the first portion 101 in the axial direction. In some embodiments, the above-mentioned axially spaced distance L1 can be between 0.5 mm and 10 mm.
  • the above axial spacing it can prevent the end part of the inflow end of the outer stent 20 from being entangled with the struts of the first portion 101 of the inner stent 10, ensuring that the artificial heart valve stent 1 can be expanded radially smoothly, and the freely hanging inflow end of the outer stent 20 can be radially deformed without restriction, and it can also prevent the sharp part of the end part of the inflow end of the outer stent 20 from piercing the baffle film 101m covered on the first portion 101, thus avoiding leakage.
  • the first portion 101 of the inner stent 10 comprises a plurality of support rods 101a, which are interconnected to form a plurality of unit patterns 101b
  • the second portion 102 of the inner stent 10 comprises a plurality of support rods 102a, which are interconnected to form a plurality of unit patterns 102b.
  • Any unit pattern can be a rhombus, triangle or other suitable pattern
  • the area of the unit patterns 101b and 102b can be uniform or different, and suitable unit pattern and area can be selected according to the needs, which will not be repeated here.
  • the first portion 101 and the second portion 102 of the inner stent 10 can be formed integrally, and they can also be connected together after being manufactured separately, for example, through the connecting piece 103 to form an integrated structure.
  • the support rod can be formed by cutting, and the cutting method can be wire cutting or laser cutting.
  • alaser cutting machine can be used to cut a nickel-titanium tube into a required shape, and after a heat shaping treatment, the compressed state and the expanded state are formed. The compressed state is maintained in the delivery device, and the expanded state is maintained after being released in the body.
  • the support rods can also be weaved by shape memory materials, for example, super-elastic nickel-titanium wire can be selected for weaving and heat setting treatment into a desired shape.
  • the second portion 102 of the inner stent 10 is generally an approximate cylindrical structure, the inflow end of the second portion 102 is connected to the first portion 101, and the outflow end can be provided with a connecting hole 104 for connecting with the outer stent 20.
  • the first portion 101 of the inner stent 10 comprises a first expansion part 1011 connected with the second portion 102, and the radial dimension of the first expansion part 1011 gradually increases from the connection with the second portion 102 toward the inflow end.
  • the radial expansion angle B of the first expansion part 1011 ranges from 45° to 90°, and the radial expansion angle B here refers to the opening angle of the outer contour tangent of the first expansion part 1011 with respect to the central axis AA of the inner stent 10.
  • the first portion 101 can be the first expansion part 1011 as a whole, and it can also comprise the first expansion part 1011 and the second expansion part 1012 connected to the first expansion part 1011 in the axial direction, wherein the radial dimension of the second expansion part 1012 gradually increases from the connection with the first expansion part 1011 toward the inflow end, and the radial expansion angle B of the first expansion part 1011 relative to the axial direction is greater than the radial expansion angle B1 of the second expansion part 1012 relative to the axial direction, i.e., B>B1.
  • the second portion 102 is approximately cylindrical, and the radial dimensions are basically the same everywhere in the axial direction; and the radial dimension of the first expansion part 1011 of the first portion 101 gradually increases from the connection with the second portion 102 toward the inflow end. Therefore, the radial dimension of the first portion 101 anywhere along the axial direction is greater than the radial dimension of the second portion 102.
  • the radial dimension d1 of the end part of the inflow end of the first portion 101 in the cross section passing through the central axis AA can be taken as the radial dimension of the first portion 101, and the radial dimension d2 of the second portion 102 in the cross section passing through the central axis AA is taken as the radial dimension of the second portion 102; and d1 is greater than d2, for example, the dimension of d1 ranges from 40 mm to 70 mm, and according to clinical application experience, in order to have a more excellent artificial valve performance, the dimension of d2 ranges from 25 mm to 30 mm. In some embodiments, the dimension of d1 and d2 can also be other values, which will not be listed here.
  • the whole first portion 101 can be covered with a baffle film, the material of the baffle film can be PET, PTFE, e-PTFE, and the like.; the second portion 102 can also be sutured with the baffle film, and the material of the baffle film can be PET, PTFE, e-PTFE, and the like; that is, both the first portion 101 and the second portion 102 of the inner stent 10 are covered with a baffle film to further prevent paravalvular leakage.
  • the baffle film covered on the second portion 102 may be the same as or different from the baffle film on the first portion 101, which is not limited here.
  • the outer stent 20 comprises a plurality of support rods 200a, and the plurality of support rods 200a are interconnected to form a plurality of unit patterns 200b.
  • the unit pattern 200b can be a rhombus, triangle or other suitable patterns, the area of the unit pattern 200b can be uniform or different, and a suitable pattern and area can be selected for the unit pattern 200b according to needs, which will not be repeated here.
  • the support rod 200a can be formed by cutting a shape memory material, the cutting method can be wire cutting or laser cutting.
  • a laser cutting machine can be used to cut a nickel-titanium tube into a required shape, and after a heat setting treatment, the compressed state and the expanded state are formed. The compressed state is maintained in the delivery device, and the expanded state is maintained after being released in the body.
  • the support rod 200a can also be made by weaving, for example, super-elastic nickel-titanium wire can be selected for weaving and heat setting treatment into a desired shape.
  • the deformation resistance of the inner stent 10 is higher than the deformation resistance of the outer stent 20.
  • the deformation resistance refers to the deformation resistance of the stent against external stress. Under the same stress, the greater the deformation resistance, the smaller the deformation amplitude, and vice versa. In other words, the higher the resistance to deformation, the lower the flexibility.
  • the outer stent 20 By setting the outer stent 20 to have lower deformation resistance, it can improve its ability to conform to the radial compression of the valve annulus to form a radially inward depression deformation at its inflow end and nearby parts, and the bulging part G on the outer stent 20 is formed on the outflow side of the depression deformation, so as to ensure that the artificial heart valve stent 1 will not move toward the atrial side under the scouring of blood flow and cause it to fall off.
  • the inner stent 10 not only needs to withstand the pulling force of the artificial valve leaflets inside, but also needs to be able to maintain the first portion or inner skirt 101 fits with the atrial side of the valve annulus, therefore, the inner stent 10 is provided with high deformation resistance; when the outer stent 20 is deformed by the radial compression of the valve annulus, the inner stent 10 will not compress and deform the artificial valve leaflet, ensuring the “valve” works smoothly, and the inner skirt 101 will not be affected by the deformation of the outer stent 20 and create a gap with the atrial side of the valve annulus, reducing paravalvular leakage.
  • the area of the unit pattern 200b of the outer stent 20 can be set to be larger than the area of the unit pattern 102b of the inner stent 10; the cross-sectional area of the support rod 200a of the outer stent 20 can be set to be smaller than the cross-sectional area of the support rod 102a of the inner stent 10; and the support rod 102a of the inner stent 10 can also be made of a material with greater hardness, and the support rod 200a of the outer stent 20 is made of a material with a relatively small hardness.
  • the outer stent 20 from the outflow end to the inflow end along the axial direction comprises a first section 201 approximately funnel-shaped and a second section 202 connected with the first section, wherein the nozzle part of the first section 201 is fixedly connected with the second portion 102, the top opening of the first section 201 is connected with the outflow end of the second section 202, and the inflow end of the second section 202 hangs freely.
  • the first section 201 and the second section 202 can be separately manufactured and then connected together, and they can also be formed integrally.
  • the first section 201 and the second section 202 in this embodiment are integrally formed by laser cutting.
  • the second section 202 of the outer stent 20 can be approximately cylindrical, and its radial cross-sectional shape perpendicular to the axial direction can be O-shaped (refer to Fig. 6) or D-shaped (refer to Fig. 7) . Adopting the O-shaped radial cross-sectional shape can make the outer stent 20 easier to manufacture, and adopting the D-shaped radial cross-sectional shape can make the outer stent 20 more fit the actual physiological anatomy of the valve annulus, so that the structural topography of the outer stent 20 matches the cross-sectional shape of the valve annulus space in which it is accommodated, thereby avoiding pressure on the ventricular outflow tract.
  • the radial dimension d0 of the second section 202 in the cross section passing through the central axis AA is close to the dimension of the natural valve annulus, and the dimension ranges from 30 mm to 60 mm in some embodiments.
  • the first section 201 is approximately funnel-shaped, the end with the smaller opening at the outflow end is the nozzle part, and the end with the larger opening at the inflow end is the top opening.
  • the first section 201 gradually shrinks from the top opening to the nozzle part, the shrinkage angle A is the opening angle of the tangent to the outer contour on the same diameter of the nozzle part, and the shrinkage angle A ranges from 90° to 150°.
  • the nozzle part can be fixedly connected with the inner stent 10 through crimping, riveting, welding, or suture binding.
  • the nozzle part may be provided with a connecting hole 204, which is aligned with a connecting hole 104 opened at the outflow end of the inner stent 10, and a rivet passes through the connecting holes 204 and 104 to fix the inner stent 10 and the outer stent 20 together.
  • the first section 201 comprises a plurality of support rods 201a which are interconnected to form a plurality of unit patterns 201b
  • the second section 202 comprises a plurality of support rods 202a, which are interconnected to form a plurality of unit patterns 202b.
  • the unit patterns 201b and 202b can be rhombus, triangles, or other suitable patterns respectively, the area of the unit patterns can be uniform or different, and suitable patterns and areas can be selected for the unit patterns according to needs, which will not be repeated here.
  • the radial supporting force of the first section 201 is greater than the radial supporting force of the second section 202.
  • the radial supporting force here refers to the reaction force generated after the stent is compressed in the radial direction, and under the same radial compression conditions, the greater the reaction force, the smaller the stress deformation and the greater the radial supporting force, and vice versa.
  • the first section 201 is connected with the inner stent 10, referring to Fig. 15 and Fig.
  • the first section 201 can provide a larger radial supporting force, with less stress deformation, so as not to compress the inner stent 10, and then avoid compressing the artificial valve leaflet in the inner stent 10; and the radial supporting force of the second section 202 is relatively small, under the same radial compression conditions, the radial supporting force is relatively small and the stress deformation is relatively large, so that it can fit the valve annulus more compliantly and improve implantation stability.
  • the area of the unit pattern 201b of the first section 201 can be set to be smaller than the area of the unit pattern 202b of the second section 202; the width of the support rod 201a of the first section 201 can be set to be greater than the width of the support rod 202a of the second section 202; and also the support rod 201a of the first section 201 can be made of a material with a relatively large hardness, and the support rod 202a of the second section 202 can be made of a material with a relatively small hardness.
  • the width dimension should not exceed 0.5 mm at most, and the dimensions are set to be 0.3 mm, 0.4 mm, and 0.5 mm in some embodiments. It should be noted that the above methods are only used as an example and is not a limitation of the present disclosure. Under the teaching of the present disclosure, one skilled in the art can adopt other suitable methods to realize that the radial supporting force of the first section 201 is greater than that of the second section 202, which are all within the protection scope of the present disclosure.
  • the outer stent 20 also comprises at least one limit rod 203.
  • the limit rod 203 comprises a rod body 2031 connected with the nozzle part and a hanging end head 2032 connected to the rod body 2031 along the axial direction.
  • the transverse dimension of the end head 2032 that is the dimension in the LH direction shown in Fig. 8a to Fig. 8c, is larger than the transverse dimension of the rod body, the transverse direction LH is perpendicular to the axial direction.
  • the limit rod 203 is generally a T-shaped structure, which is convenient to be placed in the limiting slot of the delivery device, to connect the artificial heart valve stent 1 to the delivery device.
  • the end head can be round; referring to Fig. 8b, the end head can be square; and referring to 8c, the end head can be semicircular.
  • a imaging mechanism can also be provided on the outer stent 20 and/or on the inner stent 10.
  • the C1 area in Fig. 9 is provided with a imaging mechanism.
  • the imaging mechanism can be a imaging block fixed on the outer stent 20; referring to Fig. 10b, it can also be a imaging winding wound on the outer stent 20; referring to Fig. 10c, it can also be a imaging ring surrounding the outer stent 20; or it can be a combination of the above imaging mechanism.
  • asimilar imaging mechanism can also be provided on the inner stent 10, which will not be repeated here.
  • the imaging mechanism is made of a imaging material, such as tungsten, gold, platinum, tantalum and other common imaging materials.
  • the artificial heart valve 01 of Example 1 of the present disclosure comprises an artificial valve leaflet 2 and an artificial heart valve stent 1 as described above, the artificial valve leaflet 2 is fixedly connected to the inner stent 10 in the inner stent 10 of the artificial heart valve stent 1.
  • Two, three or other suitable numbers of the artificial valve leaflet 2 can be used, and the edges of any two adjacent artificial valve leaflets are coapted with each other in the circumferential direction.
  • the artificial valve leaflet 2 is made of biological valve leaflet materials, such as bovine pericardium, porcine pericardium and other biological tissue materials.
  • a polymer material such as ultra-high molecular weight polyethylene can also be used.
  • the outer stent 20 when the artificial heart valve 01 is implanted into the native valve annulus M in the heart, the outer stent 20 is compressed by a radial force F. Since the inflow end of the outer stent 20 hangs freely, the second section 202 near the inflow end is not connected to the inner stent 10 and they are radially spaced apart from each other.
  • the inflow end of the second section 202 is prone to deform under the action of F; while the first section 201 near the outflow end of the outer stent 20 is fixedly connected to the inner stent 10, and has a strong radial supporting force, the stress deformation is small under the action of F, so that the inflow end of the second section 202 would deform inwardly under the action of F, while the outflow end of the first section 201 would continue to maintain the original state.
  • This deformation will cause the part of the outer stent near the connection of the first section 201 and the second section 202 or at the outflow side of the depression deformation to bulge outwards, forming a bulging part G, which makes the outer stent 20 generally in a shape of small at both ends and large in the middle.
  • the bulging part G on the outer stent 20 can prevent the artificial heart valve stent 1 from moving toward the atrial side.
  • the valve annulus M would actually compress the artificial heart valve 01 from multiple directions and multiple angles, such as the inflow end of the outer stent 20 is compressed by the radial force F2, causing the inflow end of the outer stent 20 to depress inward.
  • the bulging part of the outer stent 20 is subjected to the compression force F3 of the valve annulus M, making the bulge part G fit to the valve annulus M more closely.
  • the first portion 101 of the inner stent 10 protrudes toward the inflow end relative to the outer stent 20, which is attached to the atrial side of the valve annulus M in the atrium LA, supported by the supporting force F1 provided by the valve annulus M, and is not affected by the radial deformation of the outer stent 20, so that the artificial heart valve 01 can be stably compressed or held in the position of the valve annulus M.
  • the stent part of the first portion 101 protruding toward the inflow end relative to the outer stent 20 is also covered with a baffle film, which is attached to the atrial side of the valve annulus M together with the inner stent 10 to isolate the atrium LA and the ventricle LV, and it is not affected by the radial deformation of the outer stent 20, thereby ensuring the sealing of the atrial side and effectively preventing paravalvular leakage.
  • the difference of the artificial heart valve stent of Example 2 of the present disclosure is that the outer stent 20 is also covered with a baffle film 20b.
  • the baffle film 20b is sutured on the support rod 20a, thereby further enhancing the sealing performance and avoiding perivalvular leakage.
  • the baffle film 20b can be made of the same material as the baffle film on the inner stent or a different material.
  • the baffle film 101m covering the part of the first portion 101 protruding toward the inflow end relative to the outer stent 20 or the baffle film covering the entire inner stent 10 can be sealed on the atrium LA side, and the baffle film 20b on the outer stent 20 can be sealed on the ventricle LV side. Therefore, both the atrial side of the valve annulus and the ventricle side of the valve annulus are provided with baffle films for sealing, which can further strengthen the sealing effect of the artificial heart valve 01, thereby further reducing the probability of paravalvular leakage.
  • baffle film 101m it is not necessary to provide a baffle film on the outer stent, but an optional configuration.
  • the prevention of paravalvular leakage can be effectively achieved by covering the baffle film 101m on the part of the first portion 101 protruding toward the inflow end relative to the outer stent 20.
  • the difference of the artificial heart valve stent of Example 3 of the present disclosure is that the radial dimension of the second section 202 of the outer stent 20 gradually decreases from the connection with the first section 201 toward the inflow end, so as to further improve the adaptability of the outer stent 20 to the valve annulus.
  • the second section 202 is shaped toward the inflow end into a structure gradually inclined and gathered toward the central axis AA, but its freely hanging inflow end is still radially spaced apart from the inner stent 10, and its radial inclination distance L'is smaller than the gap L between the inner stent 10 and the middle part of the outer stent 10.
  • the radial inclination distance L' refers to the radial distance between the end of the outflow end and the end of the inflow end of the second section 202, wherein the end of the outflow end is connected with the first section 201, and the end of the inflow end is freely hanging.
  • Example 1 when the outer stent 20 in this example is compressed by the valve annulus, the outer stent 20 can only deform slightly or even does not deform to adapt to the shape and size of the valve annulus, thereby improving the adaptability to the valve annulus and enhancing the positional stability of the artificial heart valve after the implantation of the valve annulus.
  • the difference of the artificial heart valve stent of Example 4 of the present disclosure is that near the inflow end of the second section 202 of the outer stent 20 has a depression part 202d around the circumference.
  • the depression part 202d is located at a region which is formed between the connection of the second section and the first section and the freely hanging inflow end of the second section, where the outer stent is depressed toward the central axis.
  • the region between the lines D1 and D2 in Fig. 27 represents the depression part 202d.
  • the depression part202d can be formed by heat setting during the manufacturing process. When the outer stent 20 is compressed by the valve annulus, the depression part 202d fits the valve annulus in the natural state, which enhances the adaptability of the artificial heart valve stent, thereby improving the positional stability of the artificial heart valve stent.
  • the difference of the artificial heart valve stent of Example 5 of the present disclosure is that the outer stent 20 further comprises at least one barb 207 provided on the second section 202 or/and near the inflow end of the first section 201, and the barbs 207 extend outward and to the inflow end simultaneously.
  • the above-mentioned barbs 207 extend radially outward while expanding toward the inflow end, the angle between the extending direction AB and the central axis AA is defined as the expansion angle a, and the expansion angle a ranges from 30° to 90° in some embodiments.
  • the number of barbs 207 can be one or more, and the plurality of barbs 207 can be randomly distributed, or can be distributed along the circumference of the outer stent 20.
  • one or more layers of barbs 207 can be provided around the circumference of the outer stent 20, and the number of barbs 207 is at least three.
  • the artificial heart valve of the present disclosure can be received in a delivery device with a relatively small diameter after being compressed radially, and delivered to the vicinity of the mitral valve and released by transapical, transatrial, or transfemoral vein-atrial septum, so as to replace the diseased natural valve annulus.
  • the delivery device comprises an outer sheath and a mandrel penetrating in the outer sheath, wherein the mandrel and the outer sheath can move relative to each other in an axial direction, the artificial heart valve radially compressed is received in the gap between the distal end portion of the mandrel and the distal end portion of the outer sheath.
  • the mandrel is provided with at least one limiting slot for cooperating with the limit rod 203 on the artificial heart valve stent 1.
  • the limiting slot can limit the instantaneous release of the artificial heart valve, which is convenient for the operator to observe through medical imaging, then the cooperation between the limiting slot and the limit rod 203 is released until the release position is reasonable to completely release the artificial heart valve.
  • the artificial heart valve of the present disclosure can also be directly implanted into the heart to replace the diseased natural mitral valve by means of surgery, which will not be repeated here.
  • the artificial heart valve of the present disclosure can also be implanted into the heart in various ways to replace the diseased natural tricuspid valve, which will not be repeated here.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic 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 un stent de valve cardiaque artificielle, une valve cardiaque artificielle et un système de remplacement de valve cardiaque artificielle. Le stent de valve cardiaque artificielle comprend un stent interne et un stent externe, le stent interne comprenant une première partie et une seconde partie en séquence d'une extrémité d'entrée à une extrémité de sortie le long d'une direction axiale, une dimension radiale de la première partie est supérieure à une dimension radiale de la seconde partie, au moins une partie de la seconde partie est emboîtée dans le stent externe, et au moins une partie de la première partie fait saillie vers l'extrémité d'entrée par rapport au stent externe, et une partie de la première partie faisant saillie vers l'extrémité d'entrée par rapport au stent externe est recouverte d'un film déflecteur.
PCT/CN2021/118344 2020-09-15 2021-09-14 Stent de valve cardiaque artificielle, valve cardiaque artificielle et système de remplacement de valve cardiaque artificielle Ceased WO2022057799A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202010971429.0 2020-09-15
CN202022020650.6 2020-09-15
CN202010971429.0A CN114176833A (zh) 2020-09-15 2020-09-15 人工心脏瓣膜支架及人工心脏瓣膜
CN202022020650.6U CN212662031U (zh) 2020-09-15 2020-09-15 人工心脏瓣膜支架、人工心脏瓣膜及人工心脏瓣膜置换系统

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115317196A (zh) * 2022-08-01 2022-11-11 上海翰凌医疗器械有限公司 一种经导管置换瓣膜装置及其支架
CN117379228A (zh) * 2022-07-04 2024-01-12 北京新尖科技有限公司 心脏瓣膜假体
WO2024157129A1 (fr) * 2023-01-27 2024-08-02 Medtronic, Inc. Valve prothétique à densité de tassement réduite
EP4574094A1 (fr) * 2023-12-21 2025-06-25 Tricares GmbH Endoprothèse et prothèse de valvule cardiaque de remplacement à conception de cellule unique

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Publication number Priority date Publication date Assignee Title
US20130304200A1 (en) * 2011-10-19 2013-11-14 Foundry Newco Xii, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
WO2015128747A2 (fr) * 2014-02-28 2015-09-03 Highlife Sas Prothèse valvulaire transcathéter
US20200163760A1 (en) * 2016-08-10 2020-05-28 Cardiovalve Ltd. Prosthetic valve with leaflet connectors

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130304200A1 (en) * 2011-10-19 2013-11-14 Foundry Newco Xii, Inc. Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods
WO2015128747A2 (fr) * 2014-02-28 2015-09-03 Highlife Sas Prothèse valvulaire transcathéter
US20200163760A1 (en) * 2016-08-10 2020-05-28 Cardiovalve Ltd. Prosthetic valve with leaflet connectors

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117379228A (zh) * 2022-07-04 2024-01-12 北京新尖科技有限公司 心脏瓣膜假体
CN115317196A (zh) * 2022-08-01 2022-11-11 上海翰凌医疗器械有限公司 一种经导管置换瓣膜装置及其支架
WO2024157129A1 (fr) * 2023-01-27 2024-08-02 Medtronic, Inc. Valve prothétique à densité de tassement réduite
EP4574094A1 (fr) * 2023-12-21 2025-06-25 Tricares GmbH Endoprothèse et prothèse de valvule cardiaque de remplacement à conception de cellule unique
WO2025132619A1 (fr) * 2023-12-21 2025-06-26 Tricares Gmbh Endoprothèse et prothèse de valvule cardiaque de remplacement ayant une conception monocellulaire

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