HRP20230341T1 - Pokrov i postupak sastavljanja za transkateterski zalistak - Google Patents

Pokrov i postupak sastavljanja za transkateterski zalistak Download PDF

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Publication number
HRP20230341T1
HRP20230341T1 HRP20230341TT HRP20230341T HRP20230341T1 HR P20230341 T1 HRP20230341 T1 HR P20230341T1 HR P20230341T T HRP20230341T T HR P20230341TT HR P20230341 T HRP20230341 T HR P20230341T HR P20230341 T1 HRP20230341 T1 HR P20230341T1
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Croatia
Prior art keywords
cover
frame
valve prosthesis
loops
layer
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HRP20230341TT
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English (en)
Inventor
Liron TAYEB
Ilan TAMIR
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Edwards Lifesciences Corporation
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Publication of HRP20230341T1 publication Critical patent/HRP20230341T1/hr

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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
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—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
    • A61F2/2412—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
    • 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
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Prostheses (AREA)
  • Protection Of Pipes Against Damage, Friction, And Corrosion (AREA)
  • Pens And Brushes (AREA)
  • Forging (AREA)

Claims (14)

1. Transkateterski srčani zalistak koji sadrži: protezu zaliska (1) koja se sastoji od radijalno proširivog i sklopivog okvira (10) i mnoštva listića zaliska (20) smještenih najmanje djelomično u okviru (10) i konfiguriranih za kontrolu protoka krvi kroz protezu zaliska (1), pri čemu okvir (10) ima prvi kraj (3), drugi kraj (2) i vanjsku površinu koja se proteže od prvog kraja (3) do drugog kraja (2); i pokrov (100, 200, 300, 400, 500) spojen na protezu zaliska (1), pri čemu pokrov (100, 200, 300, 400, 500) prekriva najmanje prvi kraj (3) i uglavnom sve vanjske površine okvira (10), pokrov (100, 200, 300, 400, 500) sadrži prvi sloj (501) pričvršćen na vanjsku površinu okvira (10) i drugi sloj (502), naznačen time što je drugi sloj (502) postavljen na vanjsku površinu prvog sloja (501) i podešen da klizi ili se pomiče duž vanjske površine prvog sloja (501).
2. Transkateterski srčani zalistak prema zahtjevu 1, naznačen time što pokrov (100, 200, 300, 400, 500) prekriva prvi kraj (3), drugi kraj (2) i cijelu vanjsku površinu okvira (10).
3. Pokrov (100, 200, 300, 400, 500) za protezu zaliska (1) koji se sastoji od okvira (10) i mnoštva listića zaliska (20) smještenih najmanje djelomično u okviru (10) i konfiguriranih za kontroliranje protoka krvi kroz protezu zaliska (1), pri čemu okvir (10) ima prvi kraj (3) koji definira izlazni kraj proteze zaliska (1), drugi kraj (2) koji definira ulazni kraj proteze zaliska (1), te vanjsku površinu koja se proteže od prvog kraja (3) do drugog kraja (2), pokrova (100, 200, 300, 400, 500) koji sadrži: pokrovni sloj podešen da prekriva vanjsku površinu okvira (10) na prvom kraju (3); i mnoštvo uzica (220, 230, 320, 420, 430) spojenih na pokrovni sloj, uzice (220, 230, 320, 420, 430) su postavljene da olakšaju pričvršćivanje pokrovnog sloja na protezu zaliska (1), naznačen time što mnoštvo uzica (220, 230, 320, 420, 430) sadrži mnoštvo omči (320, 321, 430).
4. Pokrov (100, 200, 300, 400, 500) prema zahtjevu 3, naznačen time što pokrov dalje sadrži drugi sloj (212, 314, 412, 502).
5. Pokrov (100, 200, 300, 400, 500) prema jednom od zahtjeva 3 do 4, naznačen time što je mnoštvo omči (320, 321, 430) postavljeno na najmanje jednom kraju (2, 3) pokrovnog sloja.
6. Pokrov (100, 200, 300, 400, 500) prema zahtjevu 5, naznačen time što se mnoštvo omči (320, 321, 430) postavljenih na prvom kraju (312) pokrovnog sloja drži između pokrovnog sloja i drugog sloja (212, 314, 412, 502) pokrova.
7. Pokrov (100, 200, 300, 400, 500) prema jednom od zahtjeva 3 do 6, naznačen time što mnoštvo uzica (220, 230, 320, 420, 430) sadrži mnoštvo omči (320, 321, 430) koje se mogu odvojiti od pokrovnog sloja, te pri čemu je svaka od mnoštva omči postavljena kroz otvor (413) pokrovnog sloja, tako da je najmanje dio omče (320, 321, 430) postavljen na svakoj strani pokrovnog sloja.
8. Sustav koji sadrži: protezu zaliska (1) koja se sastoji od radijalno proširivog i sklopivog okvira (10) i mnoštva listića zaliska (20) smještenih najmanje djelomično u okviru (10) i konfiguriranih za kontrolu protoka krvi kroz protezu zaliska (1), pri čemu okvir (10) ima prvi kraj (3) koji definira izlazni kraj proteze zaliska (1), drugi kraj (2) koji definira ulazni kraj proteze zaliska (1), te vanjsku površinu koja se proteže od prvog kraja (3) prema drugom kraju (2), pri čemu okvir (10) dalje sadrži mnoštvo vrhova (14) na najmanje prvom kraju (3); i pokrov (100, 200, 300, 400, 500) koji je odvojen od i može se pričvrstiti na protezu zaliska (1) radi prekrivanja vanjske površine okvira (10) na prvom kraju (3), pokrov (100, 200, 300, 400, 500) se sastoji od najmanje jedne uzice (220, 230, 320, 420, 430) koja je konfigurirana da olakša pričvršćivanje pokrova (100, 200, 300, 400, 500) na protezu zaliska (1), naznačen time što najmanje jedna uzica (220, 230, 320, 420, 430) sadrži mnoštvo omči (320, 321, 430) od kojih je svaka konfigurirana da zahvaća odgovarajući vrh (14) okvira (10).
9. Sustav prema zahtjevu 8, naznačen time što je mnoštvo omči (320, 321, 430) razmaknuto od kraja pokrova, tako da kada su omče (320, 321, 430) zahvaćene s odgovarajućim vrhovima (14 ) okvira (10), kutovi vrhova (14) okvira (10) su prekriveni pokrovom (100, 200, 300, 400, 500).
10. Sustav prema jednom od zahtjeva 8 do 9, naznačen time što najmanje jedna uzica (220, 230, 320, 420, 430) sadrži mnoštvo omči (320, 321, 430) koje se mogu odvojiti od ostalih dijelova pokrova, pri čemu je svaka od mnoštva omči (320, 321, 430) postavljena kroz otvor (413) pokrova (100, 200, 300, 400, 500), tako da je najmanje dio omče (320, 321, 430) postavljen sa svake strane otvora.
11. Sustav prema zahtjevu 10, naznačen time što nadalje sadrži sidro (60, 70) koje definira prolaznu rupu s profilom koji odgovara profilu vanjske površine okvira (10), pri čemu je pokrov (100, 200, 300, 400, 500) konfiguriran da se postavlja između okvira (10) i sidra (60, 70) kada je proteza zaliska (1) u sidru (60, 70).
12. Postupak za pričvršćivanje pokrova (100, 200, 300, 400, 500) na protezu zaliska (1), pri čemu proteza zaliska (1) sadrži okvir (10) i mnoštvo listića zaliska (20) postavljenih najmanje djelomično u okviru (10) i konfiguriranih za kontrolu protoka krvi kroz protezu zaliska (1), pri čemu okvir (10) ima prvi kraj (3), drugi kraj (2) i vanjsku površinu koja se proteže od prvog kraja (3) do drugog kraja (2), pokrov (100, 200, 300, 400, 500) sadrži pokrovni sloj i mnoštvo omči (320, 321, 430), te postupak uključuje: postavljanje pokrovnog sloja oko proteze zaliska (1); i pričvršćivanje pokrovnog sloja na protezu zaliska (1) korištenjem mnoštva omči (320, 321, 430).
13. Postupak prema zahtjevu 12, naznačen time što okvir (10) nadalje sadrži mnoštvo vrhova (14) na najmanje jednom od prvog kraja (3) ili drugog kraja (2), te pri čemu je svaka od mnoštva omči (320, 321, 430) postavljena oko odgovarajućeg vrha (14) okvira (10) radi pričvršćivanja pokrovnog sloja na protezu zaliska (1).
14. Postupak prema zahtjevu 12 ili 13, naznačen time što se mnoštvo omči (320, 321, 430) može odvojiti od pokrovnog sloja, te pri čemu pričvršćivanje pokrovnog sloja na protezu zaliska (1) obuhvaća: pozicioniranje omči (320, 321, 430) kroz okvir zaliska (10); provlačenje uzica (440) kroz omče (320, 321, 430) na unutarnjoj strani proteze zaliska (1); povlačenje omči (320, 321, 430) kroz pokrovni sloj da se provuku uzice (440) kroz pokrov (100, 200, 300, 400, 500) i na vanjsku stranu proteze zaliska (1); i vezivanje uzica (430) za pričvršćivanje pokrova (100, 200, 300, 400, 500) na protezu zaliska (1).
HRP20230341TT 2015-08-24 2016-08-22 Pokrov i postupak sastavljanja za transkateterski zalistak HRP20230341T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201562209180P 2015-08-24 2015-08-24
US15/240,570 US10631977B2 (en) 2015-08-24 2016-08-18 Covering and assembly method for transcatheter valve
EP16839937.6A EP3340932B1 (en) 2015-08-24 2016-08-22 Covering and assembly method for transcatheter valve
PCT/US2016/048028 WO2017035069A1 (en) 2015-08-24 2016-08-22 Covering and assembly method for transcatheter valve

Publications (1)

Publication Number Publication Date
HRP20230341T1 true HRP20230341T1 (hr) 2023-06-09

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US (3) US10631977B2 (hr)
EP (2) EP4186474A1 (hr)
CN (2) CN111973320B (hr)
DK (1) DK3340932T3 (hr)
ES (1) ES2942360T3 (hr)
FI (1) FI3340932T3 (hr)
HR (1) HRP20230341T1 (hr)
HU (1) HUE061658T2 (hr)
PL (1) PL3340932T3 (hr)
PT (1) PT3340932T (hr)
SI (1) SI3340932T1 (hr)
WO (1) WO2017035069A1 (hr)

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US20170056163A1 (en) 2017-03-02
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US20240081981A1 (en) 2024-03-14
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EP4186474A1 (en) 2023-05-31
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PT3340932T (pt) 2023-04-18
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EP3340932A4 (en) 2018-11-21
SI3340932T1 (sl) 2023-05-31
EP3340932B1 (en) 2023-01-18
US20200253728A1 (en) 2020-08-13
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CN108135698A (zh) 2018-06-08

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