WO2018151247A1 - Valve cardiaque artificielle - Google Patents

Valve cardiaque artificielle Download PDF

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Publication number
WO2018151247A1
WO2018151247A1 PCT/JP2018/005444 JP2018005444W WO2018151247A1 WO 2018151247 A1 WO2018151247 A1 WO 2018151247A1 JP 2018005444 W JP2018005444 W JP 2018005444W WO 2018151247 A1 WO2018151247 A1 WO 2018151247A1
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WO
WIPO (PCT)
Prior art keywords
leaflet
heart valve
valve
artificial
prosthetic heart
Prior art date
Application number
PCT/JP2018/005444
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English (en)
Japanese (ja)
Inventor
実 田端
Original Assignee
実 田端
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 JP2017027391A external-priority patent/JP6159041B1/ja
Priority claimed from JP2017247166A external-priority patent/JP6388463B1/ja
Application filed by 実 田端 filed Critical 実 田端
Priority to CN201880012171.2A priority Critical patent/CN110337280A/zh
Priority to CN202210855382.0A priority patent/CN115153965A/zh
Priority to EP18753553.9A priority patent/EP3583917A4/fr
Priority to US16/486,501 priority patent/US20190358034A1/en
Publication of WO2018151247A1 publication Critical patent/WO2018151247A1/fr
Priority to US17/403,889 priority patent/US20210369453A1/en

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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
    • 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
    • A61F2/2412—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
    • A61F2/2415—Manufacturing methods
    • 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
    • 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
    • A61F2/2469—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 resilient valve members, e.g. conical spiral
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical

Definitions

  • the present invention relates to an artificial heart valve. More specifically, the present invention relates to a medical artificial heart valve that is installed near a mitral valve or a tricuspid valve and assists the functions of the mitral valve and the tricuspid valve.
  • Japanese Patent No. 5392539 discloses a stentless artificial mitral valve and an artificial heart leaflet for treating mitral regurgitation.
  • This artificial mitral valve is sutured to the heart annulus (paragraph [0032] of this document).
  • this prosthetic mitral valve is an implant prosthetic mitral valve, and in order to be implanted in the human body, it is necessary to perform thoracotomy. Thoracotomy is a burden on the patient and takes a long time to recover.
  • US 2012-179244 describes an artificial mitral valve using a stent. Stented prosthetic mitral valves are less invasive than implant prosthetic mitral valves.
  • the stent artificial mitral valve described in this publication does not require the patient's own mitral valve. The mitral valve itself of patients suffering from functional mitral regurgitation (FMR) is normal.
  • the mitral valve of a patient implanted with this stent prosthetic mitral valve is a disturbing presence and can interfere with the left ventricular outflow tract.
  • the tricuspid valve is a valve between the right atrium and right ventricle of the heart.
  • the tricuspid valve has the function of preventing the backflow of blood.
  • diseases such as tricuspid insufficiency (tricuspid regurgitation).
  • Japanese Patent Laid-Open No. 2016-28762 describes an artificial heart valve (artificial mitral valve or artificial tricuspid valve) using a stent.
  • This artificial heart valve also eliminates the need for the patient's own heart valve. For this reason, when an artificial valve with this stent is implanted, the interaction with the left ventricular contraction of the original mitral valve may be lost, leading to a decrease in cardiac function.
  • An object of the present invention is to provide an artificial heart valve that can assist the functions of a mitral valve and a tricuspid valve of a patient with minimal invasiveness.
  • the present invention relates to an artificial valve 1 (artificial heart valve) including a ring 3, a first valve leaf 5, and a second valve leaf 7.
  • the first valve leaf 5 and the second valve leaf 7 are connected to the ring 3 at the upper part of the artificial valve 1.
  • the first valve leaf 5 and the second valve leaf 7 are connected at a lower connection portion 9 existing at the lower portion of the artificial valve 1.
  • the first leaflet 5 and the second leaflet 7 have a portion whose width becomes narrower in the lower part of the ring 3 as it goes downward.
  • the leaflet preferably has a shape having the narrowest width at the lower end.
  • This prosthetic valve functions as a prosthetic valve that assists the function of the mitral or tricuspid valve.
  • the upper part of the first valve leaf 5 and the upper part of the second valve leaf 7 are connected at the upper connection part 11.
  • the first leaflet 5 or the second leaflet 7 is connected at a portion of 30% or more and 99% or less of the circumference of the ring 3 when the circumference of the ring 3 is 100%. Those are preferred.
  • This prosthetic valve is preferably one in which the ring 3 can be folded and opened in the left or right atrium.
  • the ring has a ring shape with a diameter of 30 mm to 60 mm.
  • any one of the ring 3, the first valve leaf 5 and the second valve leaf 7 has a locking portion 13 for locking with the left atrial wall or the right atrial wall.
  • the locking part 13 may be for locking with the right atrial wall.
  • the locking portion 13 is an adhesion portion with the left atrial wall or the right atrial wall provided in either or both of the first valve leaf 5 and the second valve leaf 7.
  • the locking part 13 may be an adhesion part with the right atrial wall.
  • This artificial heart valve is an artificial heart valve 1 including a leaflet fixing portion 2 and at least one leaflet 4.
  • the prosthetic heart valve is an artificial mitral valve or an artificial tricuspid valve.
  • the leaflet 4 is connected to the leaflet fixing portion 2 at the upper part of the artificial heart valve 1.
  • An example of the leaflet fixing portion 2 is the ring 3 or the fixed end 14.
  • the leaflet 4 has a portion 47 whose width becomes narrower as it goes downward.
  • the combination of the type of prosthetic heart valve and the leaflet fixing part 2 is arbitrary.
  • the artificial heart valve may be an artificial mitral valve, and the leaflet fixing portion 2 may be the ring 3 or a combination other than that.
  • the artificial heart valve may include means for preventing passage of an artificial mitral valve or an artificial tricuspid valve.
  • An example of the passage preventing means is a locking portion described later.
  • the leaflet fixing part 2 (I) a ring 3 or (ii) a fixed end 14 attached to a leaflet 4.
  • an artificial heart valve 1 that includes a leaflet fixing portion 2, a first valve leaf 5, and a second valve leaf 7.
  • the first leaflet 5 and the second leaflet 7 are connected to the leaflet fixing portion 2 at the upper part of the artificial heart valve 1.
  • the first valve leaf 5 and the second valve leaf 7 are connected to each other at a lower connection portion 9 existing below the artificial heart valve 1.
  • the first leaflet 5 and the second leaflet 7 have a portion whose width becomes narrower as it goes downward.
  • the first valve leaf 5 and the second valve leaf 7 may have a shape having the narrowest width below the lower connection portion 9 or the lower connection portion 9.
  • the prosthetic heart valve is an artificial mitral valve or an artificial tricuspid valve.
  • leaflet fixing portion 2 is a ring 3, a first fixed end 6 and a second fixed end 7.
  • the combination of the type of prosthetic heart valve and the leaflet fixing part 2 is arbitrary.
  • the artificial heart valve may be an artificial mitral valve
  • the leaflet fixing portion 2 may be the ring 3 or a combination other than that.
  • a preferred example of an artificial heart valve is one having a apex connection portion 10 in contact with the apex (“right ventricle or left ventricle”) below the lower connection 9 or the lower connection 9.
  • the locking portion may be one that locks or adheres to the atrial wall or the atrioventricular valve annulus.
  • any of the leaflets in the case of an artificial heart with one leaflet, the leaflet, or in the case of two artificial hearts, one or two leaflets
  • the present invention can provide an artificial heart valve that can assist the functions of a mitral valve and a tricuspid valve of a patient with minimal invasiveness.
  • FIG. 1 is a conceptual diagram showing an example of an artificial heart valve of the present invention.
  • FIG. 2 is a conceptual diagram showing an example of the artificial heart valve of the present invention.
  • FIG. 3 is a conceptual diagram for explaining organs around the heart.
  • FIG. 4 is a conceptual diagram showing an example of use of the artificial heart valve of the present invention.
  • FIG. 5 is a conceptual diagram showing an example of the artificial heart valve of the present invention having a fixed end.
  • FIG. 6 is a conceptual diagram showing an example of the artificial heart valve of the present invention having a fixed end.
  • FIG. 7 is a conceptual diagram showing an artificial tricuspid valve (artificial valve for assisting the function of the tricuspid valve) of the present invention having a fixed end.
  • FIG. 1 is a conceptual diagram showing an example of an artificial heart valve of the present invention.
  • FIG. 2 is a conceptual diagram showing an example of the artificial heart valve of the present invention.
  • FIG. 3 is a conceptual diagram for explaining organs around the heart.
  • FIG. 8 is a conceptual diagram showing an example of an artificial heart valve having one leaflet.
  • FIG. 9 is a conceptual diagram showing an example of an artificial heart valve having one leaflet.
  • FIG. 10 is a conceptual diagram showing an example of an artificial heart valve having a string-like structure.
  • FIG. 1 is a conceptual diagram showing an example of an artificial heart valve of the present invention.
  • FIG. 1A shows an external view.
  • FIG.1 (b) shows the conceptual diagram of a 1st valve leaf.
  • FIG.1 (c) shows the conceptual diagram of a 2nd leaflet.
  • the leaflet fixing portion 2 is a ring 3 and is used for a mitral valve.
  • the leaflet fixing portion 2 is fixed to the leaflets so that the first leaflets and the second leaflets can continue to be positioned above the heart valve (in the atrium).
  • fixed part 2 may continue being arrange
  • the artificial heart valve 1 of the present invention shown in FIG. 1 includes a ring 3, a first valve leaf 5, and a second valve leaf 7.
  • the first valve leaf 5 and the second valve leaf 7 may have the same shape or different shapes.
  • the first valve leaf 5 and the second valve leaf 7 are connected to the ring 3 at the upper part of the artificial heart valve 1.
  • region for example, 0.1 mm or more and 10 mm or less area
  • the first valve leaf 5 and the second valve leaf 7 are connected to each other at a lower connection portion 9 of the artificial heart valve that exists in the lower portion of the artificial heart valve 1.
  • first leaflet 5 and the second leaflet 7 have a shape portion whose width becomes narrower as it goes downward.
  • the lower connecting portion 9 may be the lower end of the first leaflet 5 and the second valve leaf 7 or may be located in a region near the lower end (for example, a region from 0.1 mm to 10 mm from the lower end). Good.
  • the first leaflet 5 and the second leaflet 7 may have a shape having the narrowest width at the lower end.
  • the first leaflet 5 and the second leaflet 7 may be wider than the lower connection portion 9 at the lower end.
  • One or both of the first valve leaf 5 and the second valve leaf 7 is preferably a person having a shape having the narrowest width at the lower end.
  • the ring 3 has, for example, a ring shape having a diameter of 30 mm to 60 mm (or 35 mm to 55 mm, 40 mm to 50 mm).
  • the ring 3 may be elliptical or circular to match the shape of the left atrium (or right atrium).
  • the ring 3 is preferably manufactured from a biocompatible material.
  • the ring may include a metal (spring) or be resinous so that it can be folded and unfolded.
  • An example of a resin ring is a silicon resin.
  • Examples of the thickness (diameter) of the ring are 1 mm or more and 20 mm or less, 5 mm or more and 15 mm or less, 1 mm or more and 5 mm or less, or 8 mm or more and 12 mm or less. In particular, with a single leaflet, it is preferable that the ring is relatively thick.
  • the first valve leaf 5 and the second valve leaf 7 can be made of a known material used for an artificial heart valve.
  • the leaflet material are membranes derived from human stem cells and tissues derived from mammals (eg, pigs, cows, horses).
  • Another example of leaflet material is using patient-derived tissue.
  • the patient-derived tissue may be regenerated using biological tissue material collected from the patient.
  • the biological tissue material is a substance necessary for forming a biological tissue.
  • biological tissue materials include fibroblasts, smooth muscle cells, endothelial cells, stem cells, ES cells, iPS cells and other animal cells, various proteins (collagen, elastin), saccharides such as hyaluronic acid, cell growth factors, and It is a cytokine.
  • a connective tissue body that can be processed can be formed on the surface of the artificial heart valve forming base material.
  • Another example of a leaflet material is resin or plastic.
  • the lower ends of the first valve leaf 5 and the second valve leaf 7 have a narrow width. For this reason, after inserting this artificial heart valve from the left ventricle and opening the ring in the left atrium (or right atrium), the first valve is inserted into the left ventricular region or the left ventricular apex 53 where the artificial heart valve is inserted.
  • the lower ends of the leaf 5 and the second leaflet 7 can be embedded.
  • the prosthetic heart valve is stable in the patient's heart. That is, the prosthetic heart valve of the present invention has a size that allows the end of the prosthetic heart valve to reach the left ventricular apex when the ring is located in the patient's left atrium (or right atrium), or Those having a length exceeding are preferred.
  • this artificial heart valve is preferably an artificial heart valve for assisting the mitral valve, the ring remains in the left atrium (or right atrium), and the lower part of the valve leaf of the artificial heart valve is the left ventricular apex.
  • the width of the portion in contact with the leaflet fixing portion 2 is the widest, and the portion that contacts the leaflet fixing portion 2 progresses downward. It is preferable that the width does not change or has a shape that becomes narrower as it goes downward. However, the shape of the leaflets 5 and 7 may have a portion that gradually increases in width while proceeding downward. Even if it is leaflets 5 and 7 which have the shape which a width
  • the first leaflet 5 shown in FIG. 1B will be described.
  • the width W1 of the upper end 21 that is a portion sewn to the ring 3 is, for example, 30 mm or more and 90 mm or less.
  • the width W1 may be not less than 40 mm and not more than 80 mm, or may be not less than 45 mm and not more than 70 mm.
  • the first leaflet is, when 100% of the circumference of the ring 3, (connected at or portions thereof) which covers 45% or less of the portion over 15% of the circumference of the ring that is preferably 20% It may be 40% or less, or 20% or more and 30% or less.
  • the leaflet 5 shown in FIG. 1B has a portion having a uniform width at the top.
  • This part is a connection part 25 with the second leaflet.
  • An example of the length (height) of the portion 25 is 1 mm or more and 10 mm or less, 2 mm or more and 8 mm or less, or 4 mm or more and 8 mm or less.
  • there is a portion 27 whose width is curvilinearly narrowed from the upper portion where the width is constant toward the lower end 23.
  • An example of the width of the lower end 23 is 2 mm or more and 20 mm or less, 3 mm or more and 10 mm or less, or 3 mm or more and 5 mm or less.
  • the height L1 of the first leaflet 5 is 20 mm or more and 70 mm or less, 25 mm or more and 65 mm or less, 30 mm or more and 40 mm or less, 40 mm or more and 70 mm or less, or 40 mm or more and 60 mm or less.
  • the specific size of the leaflets may be designed in consideration of, for example, the shape of the patient's heart, the degree of blood regurgitation, and the medical condition.
  • the shape portion whose width becomes narrower as it goes downward may be the entire height L1 of the first leaflet 5, 30% to 100%, 50% to 100%, 70% to 100%. % Or less, 80% or more and 100% or less, or 90% or more and 100% or less.
  • the upper limit of the shape portion whose width becomes narrower as it goes downward may be 99%, 98%, 97%, 95%, 91% instead of 100%.
  • the leaflet may have, for example, a shape in which the width does not change from the upper end to the middle of the leaflet, or the width becomes narrower as it goes downward. Further, the width may not change from the upper end to the middle of the leaflet, or may have a shape that becomes narrower as it goes downward, and may further have a portion that becomes wider at the lower end portion.
  • the shape portion whose width becomes narrower as it goes downward is similarly applied to the other leaflets in this specification.
  • the second leaflet 7 shown in FIG. 1C may be manufactured basically in the same manner as the first leaflet 5.
  • the second leaflet may be thicker than the first leaflet. By doing so, a difference in rigidity is created between the two leaflets, and blood backflow can be effectively prevented.
  • L3 in FIG. 1C may be approximately the same as L1 in FIG.
  • the lower end 33 of the second leaflet may have the same width as the lower end 23 of the first leaflet.
  • the upper portion 31 of the second leaflet has a gentle undulation (convex portion) 31 to match the shape of the ring.
  • the connection part 35 which is a part with constant width exists in the upper part of a 2nd valve leaf. This part may be sewn with the connection part 25 of the first leaflet. In this example, there is a portion 37 whose width decreases in a curve as it goes from the upper part where the width is constant toward the lower end 33.
  • This artificial heart valve may be one in which the upper part of the first valve leaf 5 and the upper part of the second valve leaf 7 are connected at the upper connection part 11 of the artificial heart valve 1. Then, since two leaflets are connected, the stability of the leaflets is enhanced. Further, in this artificial heart valve, the lower part of the first valve leaf and the second valve leaf are connected at the lower connection part 9. Then, the part between these connection parts can swell or squeeze. By this operation, the artificial heart valve can prevent the backflow of blood.
  • This prosthetic heart valve is preferably such that the ring 3 can be folded and opened in the left atrium (or right atrium). With such a property, this artificial heart valve can be inserted and installed in the heart like a catheter, so that a thoracotomy is not necessary for installing the artificial heart valve.
  • any one of the ring 3, the first valve leaf 5, and the second valve leaf 7 has a locking portion 13 for locking with the left atrial wall (or the right atrial wall).
  • the locking portion 13 may be an adhesion portion with the left atrial wall (or the right atrial wall) provided on either or both of the first valve leaf 5 and the second valve leaf 7. Since it has such a latching
  • locking part 13 is the some hook provided in the outer periphery of the ring 3, as illustrated in FIG. This hook engages the left atrium (or right atrium) and prevents the ring 3 from fluctuating in the left atrium (or right atrium).
  • the locking portion 13 may be a plurality of minute protrusions provided on the ring 3.
  • An example of the length (height) of the protrusion is 0.1 mm or more and 5 mm or less, and may be 0.2 mm or more and 3 mm or less, or 0.2 mm or more and 1 mm or less because the protrusion is damaged if the protrusion is too large. .
  • This protrusion may be manufactured from a material having biocompatibility.
  • the protrusion may have a coating layer on the surface.
  • the coating layer may contain, for example, trehalose or various drugs.
  • the coating layer may include an adhesion material such as fibrin or a substance that secretes an adhesion substance in vivo so that the ring or upper leaflet and the left atrium (or right atrium) adhere.
  • the first leaflet 5 or the second leaflet 7 has an adhesion part, for example, a plurality of parts are provided on the upper part of the leaflet (for example, a region within 20 mm from the region connected to the ring 3 or a region within 15 mm).
  • corrugation of this and several protrusion may be sufficient.
  • FIG. 2 is a conceptual diagram showing an example of the artificial heart valve of the present invention.
  • FIG. 2A shows an external view.
  • FIG.2 (b) shows the conceptual diagram of a 1st valve leaf.
  • FIG.2 (c) shows the conceptual diagram of a 2nd leaflet.
  • the prosthetic heart valve of the present invention does not need to cover the ring with the first and second leaflets.
  • the region where the first leaflet 5 or the second leaflet 7 is connected to the ring 3 is a region of 30% to 99% of the ring 3 (or a region of 35% to 90%).
  • Patent Document 1 Japanese Patent No. 5392539
  • an area about half of the ring is covered with two leaflets.
  • FIG. 3 is a conceptual diagram for explaining organs around the heart.
  • the arrows in the figure indicate the direction of blood flow.
  • the artificial heart valve of the present invention basically assists the function of the mitral valve 51.
  • information such as the size of the patient's heart, the state of the muscle 53 constituting the left ventricle, the shape of the left ventricle 55 and the left atrium 57, and the stage of mitral regurgitation (mitral valve function) is collected.
  • mitral regurgitation mitral valve function
  • the material and size of the artificial heart valve are decided.
  • regenerative medicine is performed to obtain the membrane material.
  • an artificial heart valve is in contact with or fixed to the apex of the left ventricle.
  • the shape of the artificial heart valve in the heart can be maintained by fixing the end of the artificial heart valve with a clip or the like outside the left ventricle.
  • the tricuspid prosthetic heart valve is made in the same way as the mitral prosthetic heart valve except that it is adjusted appropriately according to the size of the valve.
  • a ring 3 is placed in the left atrium and the left ventricle is placed. The lower part of the leaflet can be installed.
  • the artificial tricuspid valve of the present invention assists the function of the tricuspid valve and is effective in treating tricuspid regurgitation.
  • the leaflet fixing portion 2 is the first fixed end 6 and the second fixed end 8 attached to the upper portion of the first valve leaf 5 and the upper portion of the second valve leaf 7, respectively.
  • the example of the length of the fixed ends 6 and 8 is 10 mm or more and 90 mm or less.
  • the length of the fixed ends 6 and 8 may be 20 mm or more and 90 mm or less, 40 mm or more and 80 mm or less, or 45 mm or more and 70 mm or less.
  • the first fixed end 6 and the second fixed end 8 have the same length as the upper part of the first leaflet 5 and the upper part of the second valve leaf 7, respectively, or the upper part of the first leaflet 5 and the second fixed end 8, respectively. It is preferable that the length is longer than the upper part of the second leaflet 7.
  • FIG. 5 is a conceptual diagram showing an example of the artificial heart valve of the present invention having a fixed end.
  • FIG. 5A shows an external view of an example of an artificial heart valve.
  • FIG. 5B shows a conceptual diagram of the first leaflet.
  • FIG.2 (c) shows the conceptual diagram of a 2nd leaflet.
  • a first fixed end 6 is attached to the upper part of the first valve leaf 5.
  • a second fixed end 8 is attached to the upper part of the second valve leaf 7.
  • the fixed ends 6 and 8 are formed by the artificial heart valve so that the fixed ends 6 and 8 of the artificial heart valve are stably positioned in the atrium and the fixed ends 6 and 8 do not move into the ventricle.
  • the fixed ends 6 and 8 are preferably fixed to the left atrial wall or the right atrial wall by a locking portion. For this reason, the length of the fixed ends 6 and 8 may be shorter than the valve opening.
  • the locking portion the one described above can be used as appropriate, and the fixed ends 6 and 8 are stably located in the atrium by adhering the fixed ends 6 and 8 to the atrial wall and forming the adhesion portion. You may do it.
  • both ends of the first fixed end 6 and the second fixed end 8 are connected to the other ends by the support rod 12.
  • the support rod 12 is an optional element and may not be present.
  • the support rod preferably has rigidity and malleability.
  • the support rod 12 keeps the interval between the two fixed ends 6 and 8 constant (or an arrangement having a certain interval or more).
  • FIG. 6 is a conceptual diagram showing an example of the artificial heart valve of the present invention having a fixed end.
  • the prosthetic heart valve is an artificial tricuspid valve
  • an artificial tricuspid valve is inserted in the direction of the tricuspid valve from the right ventricular apex of the right ventricle and folded.
  • the leaflet fixing unit 2 is opened in a state where the leaf fixing unit 2 (ring 3, or fixed ends 6, 8) is located in the right atrium, and the leaflet fixing unit 2 is kept in the right atrium. 2 may be arranged.
  • the lower end of the artificial heart valve artificial tricuspid valve
  • the artificial heart valve with the leaflet fixing portion 2 folded is passed through the femoral vein, jugular vein, superior vena cava, or inferior vena cava. Then, it is moved to the left ventricle through the left atrium, and the lower end of the prosthetic heart valve may be led to the left ventricle, the left ventricular apex of the left ventricle, or the position where the left ventricular apex penetrates to the outside of the heart. In either case, the leaflet fixing portion 2 is opened with the leaflet fixing portion 2 positioned in the left atrium. Then, the leaflet fixing portion 2 is arranged so that the leaflet fixing portion 2 continues to exist in the left atrium.
  • FIG. 7 is a conceptual diagram showing an example of what the artificial heart valve of the present invention having a fixed end functions as an artificial tricuspid valve (artificial valve that assists the function of the tricuspid valve).
  • an artificial tricuspid valve artificial valve that assists the function of the tricuspid valve.
  • two fixed ends are accommodated in the ventricle.
  • the lower end of the prosthetic tricuspid valve exists through the apex (may be fixed to the apex later).
  • part which the apex part contacts among artificial tricuspid valves comprises an apex connection part.
  • FIG. 8 is a conceptual diagram showing an example of an artificial heart valve having one leaflet.
  • FIG. 8A shows an external view of the artificial heart valve.
  • FIG. 8B shows an external view of the leaflet 4.
  • FIG.8 (c) is a figure which shows the example of the artificial valve which has a support rod. In the example shown in FIG.
  • the leaflet 4 is one and the leaflet fixing portion 2 is formed of a ring. Rings and leaflets are as described above. However, a preferable leaflet size in the case where the leaflet is composed of one sheet will be described with reference to FIG.
  • a width W1 of the upper end 21 that is a portion sewn to the ring 3 is, for example, 30 mm or more and 90 mm or less.
  • the width W1 may be not less than 40 mm and not more than 80 mm, or may be not less than 45 mm and not more than 70 mm.
  • the leaflet preferably covers (or is connected to) 15% to 45% of the circumference of the ring, and is preferably 20% to 40%. Or 20% or more and 30% or less.
  • the leaflet shown in FIG. 1 (b) has a portion having a uniform width at the top.
  • An example of the length (height) of the portion 25 is 1 mm or more and 10 mm or less, 2 mm or more and 8 mm or less, or 4 mm or more and 8 mm or less.
  • there is a portion 27 whose width is curvilinearly narrowed from the upper portion where the width is constant toward the lower end 23.
  • An example of the width of the lower end 23 is 2 mm or more and 20 mm or less, 3 mm or more and 10 mm or less, or 3 mm or more and 5 mm or less.
  • the height L1 of the leaflets is 20 mm or more and 70 mm or less, 25 mm or more and 65 mm or less, 30 mm or more and 40 mm or less, 40 mm or more and 70 mm or less, or 40 mm or more and 60 mm or less.
  • the specific size of the leaflets may be designed in consideration of, for example, the shape of the patient's heart, the degree of blood regurgitation, and the medical condition.
  • the prosthetic heart valve of the present invention can be used not only for catheter approaches (for example, transapical approach and transvenous approach) but also in surgical procedures using surgical operations. If the prosthetic heart valve is a mitral valve, either a catheter approach, such as a transapical approach or a transvenous approach, or a surgical approach can be used. When the prosthetic heart valve is a tricuspid valve, either a catheter approach such as a transapical approach or a course vein approach or a surgical approach can be used.
  • the leaflet fixing portion 2 is fixed to the leaflets 4 so that the leaflets 4 can continue to be positioned above the heart valve (in the atrium). Moreover, the leaflet fixing
  • FIG. 9 is a conceptual diagram showing an example of an artificial heart valve having a single leaflet.
  • the leaflet fixing portion 2 is formed with a fixed end.
  • the fixed end 14 may be, for example, a curved bar or a straight bar. Further, a material having a higher hardness than the leaflets 4 is preferable.
  • the curved rod-shaped object may have a rod-shaped portion bent like a bow and a thread portion connecting the rod-shaped tip portions.
  • the fixed end 14 is preferably manufactured from a biocompatible material.
  • An example of the length of the fixed end 14 is 10 mm or more and 150 mm or less.
  • the length of the fixed end 14 may be 20 mm or more and 120 mm or less, 40 mm or more and 100 mm or less, or 45 mm or more and 90 mm or less.
  • the thickness of the fixed end 14 may be 0.1 mm or more and 3 mm or less, 0.3 mm or more and 2 mm or less, or 0.5 mm or more and 1 mm or less.
  • the leaflets 4 shown in FIG. 9A may be manufactured basically in the same manner as the first leaflets 5 and the second leaflets 7 described in FIG.
  • the leaflet has a shape that can be combined with the artificial valve, and is formed to have the widest width at the upper part of the artificial valve.
  • the shape may be a shape in which the width is smoothly widened from a portion located below the artificial valve and the width is narrowed in the middle of the lower end.
  • FIG. 10 is a conceptual diagram showing an example of an artificial heart valve having a string-like structure.
  • FIG. 10A is a conceptual diagram showing an example of a prosthetic heart valve having a string-like structure that connects the vicinity of the left and right ends of the lower end of the leaflet and a cardiac apex connection portion that exists at the lower end of the string-like structure.
  • FIG. 10B shows an example of an artificial heart valve having a notch from the vicinity of the center of the lower end of the leaflet to the upper portion of the leaflet and having a string-like structure near each of the left and right ends of the lower end of the leaflet. It is a conceptual diagram.
  • FIG.10 (c) is a conceptual diagram which shows the example of the artificial heart valve which has an apex connection part in the lower end of a leaflet.
  • FIG. 10 illustrates a fixed end as an example of the leaflet fixing portion 2.
  • an artificial heart leaflet having a string-like structure, or a leaflet fixing portion 2 may have a ring.
  • FIG. 10 depicts one leaflet.
  • a string-like structure is a site
  • the string-like structure may be made of a resin such as PTFE or polypropylene, or may be made of the same material as the leaflets.
  • the number and shape of the string-like structure is not particularly limited as long as it is connected to the leaflet, connected to the other end of the leaflet, to stabilize the leaflet, or to adjust the blood flow. Absent.
  • FIG. 10B shows an example of an artificial heart valve having a notch from the center of the lower end of the leaflet 4 toward the upper portion of the leaflet and having a string-like structure 71 near each of the left and right ends of the leaflet.
  • FIG. A fixed portion 75 is provided at the tip of the artificial heart valve string-like structure 71.
  • the fixing portion 75 is connected to the ventricular wall or the papillary muscle. Then.
  • the leaflet is connected to the ventricular wall or the papillary muscle via the string-like structure 71, and the position of the artificial heart valve becomes stable.
  • fixed part 75 may be directly provided in each of the left and right of a valve leaf lower end.
  • FIG. 10 (c) is a conceptual diagram showing an example of an artificial heart valve having a apex connection portion at the lower end of the leaflet.
  • a string-like structure extends from the lower end of the leaflet, and the apex connection portion 73 is provided at the tip thereof.
  • tip may be provided in the left-right side surface of the leaflet.
  • the fixing portion is connected to the string-like structure, it may be a part of the string-like structure and tied to the target portion.
  • the fixed part may be a string-like structure. In this case, for example, one end may be fixed to the leaflet with a thread or the like, and the other end may be connected to a target site (for example, a ventricular wall or papillary muscle).

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (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)
  • Manufacturing & Machinery (AREA)
  • Prostheses (AREA)

Abstract

[Problème] Le problème décrit par la présente invention est de fournir une valve cardiaque artificielle capable d'aider les fonctions de la valve mitrale d'un patient d'une manière minimalement invasive. [Solution] La solution selon l'invention porte sur une valve cardiaque artificielle 1 qui comprend une partie de fixation de feuillet de valve 2 et des feuillets de valve (un premier feuillet de valve 5 et un second feuillet de valve7), et dans laquelle les feuillets de valve sont reliés à la partie de fixation de feuillet de valve 2 au niveau de la partie supérieure de la valve cardiaque artificielle 1, les feuillets de valve ont chacun une région qui se rétrécit en largeur vers le bas du feuillet, et la valve cardiaque artificielle est une valve mitrale artificielle ou une valve tricuspide artificielle.
PCT/JP2018/005444 2017-02-17 2018-02-16 Valve cardiaque artificielle WO2018151247A1 (fr)

Priority Applications (5)

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CN201880012171.2A CN110337280A (zh) 2017-02-17 2018-02-16 人工心脏瓣膜
CN202210855382.0A CN115153965A (zh) 2017-02-17 2018-02-16 人工心脏瓣膜
EP18753553.9A EP3583917A4 (fr) 2017-02-17 2018-02-16 Valve cardiaque artificielle
US16/486,501 US20190358034A1 (en) 2017-02-17 2018-02-16 Artificial heart valve
US17/403,889 US20210369453A1 (en) 2017-02-17 2021-08-17 Artificial heart valve

Applications Claiming Priority (6)

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JP2017-027391 2017-02-17
JP2017027391A JP6159041B1 (ja) 2017-02-17 2017-02-17 人工弁
JP2017-113165 2017-06-08
JP2017113165 2017-06-08
JP2017247166A JP6388463B1 (ja) 2017-06-08 2017-12-25 人工心臓弁
JP2017-247166 2017-12-25

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US17/403,889 Continuation US20210369453A1 (en) 2017-02-17 2021-08-17 Artificial heart valve

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US20050075727A1 (en) * 2001-10-29 2005-04-07 Wheatley David John Mitral valve prosthesis
JP2010148633A (ja) * 2008-12-25 2010-07-08 Waseda Univ ステントレス人工僧帽弁及び人工弁葉
US20120179244A1 (en) 2009-12-08 2012-07-12 Avalon Medical, Ltd. Device and System for Transcatheter Mitral Valve Replacement
JP2015523898A (ja) * 2012-06-22 2015-08-20 ミドル・ピーク・メディカル・インコーポレイテッド 弁逆流症の経カテーテル的治療のためのデバイス、システム、および方法
JP2015536744A (ja) * 2012-12-06 2015-12-24 マイトラリクス リミテッドＭｉｔｒａｌｉｘ Ｌｔｄ． 心臓弁の機能の置換デバイスおよび方法
CN106510901A (zh) * 2016-11-21 2017-03-22 上海交通大学医学院附属上海儿童医学中心 一种新型的折叠补片一体化成环形设计
JP6159041B1 (ja) * 2017-02-17 2017-07-05 実 田端 人工弁

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US20050075727A1 (en) * 2001-10-29 2005-04-07 Wheatley David John Mitral valve prosthesis
JP2010148633A (ja) * 2008-12-25 2010-07-08 Waseda Univ ステントレス人工僧帽弁及び人工弁葉
JP5392539B2 (ja) 2008-12-25 2014-01-22 学校法人早稲田大学 ステントレス人工僧帽弁及び人工弁葉
US20120179244A1 (en) 2009-12-08 2012-07-12 Avalon Medical, Ltd. Device and System for Transcatheter Mitral Valve Replacement
JP2016028762A (ja) 2009-12-08 2016-03-03 アヴァロン メディカル リミテッド 人工心臓弁
JP2015523898A (ja) * 2012-06-22 2015-08-20 ミドル・ピーク・メディカル・インコーポレイテッド 弁逆流症の経カテーテル的治療のためのデバイス、システム、および方法
JP2015536744A (ja) * 2012-12-06 2015-12-24 マイトラリクス リミテッドＭｉｔｒａｌｉｘ Ｌｔｄ． 心臓弁の機能の置換デバイスおよび方法
CN106510901A (zh) * 2016-11-21 2017-03-22 上海交通大学医学院附属上海儿童医学中心 一种新型的折叠补片一体化成环形设计
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