HRP20230241T1 - Sustavi za postavljanje i alati za isporuku uređaja za sidrenje za protetski zalistak - Google Patents

Sustavi za postavljanje i alati za isporuku uređaja za sidrenje za protetski zalistak Download PDF

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Publication number
HRP20230241T1
HRP20230241T1 HRP20230241TT HRP20230241T HRP20230241T1 HR P20230241 T1 HRP20230241 T1 HR P20230241T1 HR P20230241T T HRP20230241T T HR P20230241TT HR P20230241 T HRP20230241 T HR P20230241T HR P20230241 T1 HRP20230241 T1 HR P20230241T1
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HR
Croatia
Prior art keywords
ring
ridge
delivery catheter
flexible
degrees
Prior art date
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HRP20230241TT
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English (en)
Inventor
Darshin S. Patel
Boaz Manash
Tri D. Tran
Ofir Witzman
Yoav ROZEN
Alexander J. Siegel
David M. Taylor
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Edwards Lifesciences Corporation
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Application filed by Edwards Lifesciences Corporation filed Critical Edwards Lifesciences Corporation
Publication of HRP20230241T1 publication Critical patent/HRP20230241T1/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
    • 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
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0138—Tip steering devices having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • 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

Claims (15)

1. Kateter za isporuku (114) za isporuku uređaja za sidrenje (1) u nativni zalistak pacijentovog srca, pri čemu je uređaj za sidrenje (1) konfiguriran za pričvršćivanje proteze na nativni zalistak, te kateter za isporuku (114) sadrži: savitljivu cijev (2030) koja sadrži proksimalni dio koji ima prvi kraj, distalni dio (117) koji ima drugi kraj i provrt (2032) koji se proteže između prvog kraja i drugog kraja odgovarajuće veličine za prolazak uređaja za sidrenje kroz njih; prvu žicu za povlačenje (2035) i drugu žicu za povlačenje (2036) koje su najmanje djelomično smještene u savitljivoj cijevi (2030); prvi prsten (2037), drugi prsten (2038) i treći prsten (2039), prvu žicu za povlačenje (2035) pričvršćenu na prvi prsten (2037) u prvoj spojnoj točki (A) i drugu žicu za povlačenje (2036) pričvršćenu na drugi prsten (2038) u drugoj spojnoj točki (B), pri čemu je druga spojna točka (B) postavljena proksimalno u odnosu na prvu spojnu točku (A) i treći prsten (2039) smješten između proksimalnog dijela savitljive cijevi (2030) i drugog prstena (2038), prvi greben (2040) i drugi greben (2041), prvi greben (2040) smješten između prvog prstena (2037) i drugog prstena (2038), a drugi greben (2041) smješten između drugog prstena (2038) ) i trećeg prstena (2039); pri čemu distalni dio (117) savitljive cijevi (2030) sadrži prvi savitljivi dio (115) i drugi savitljivi dio (116), prvi savitljivi dio (115) se proteže između prvog prstena (2037) i drugog prstena (2038), a drugi savitljivi dio (116) se proteže između drugog prstena (2038) i trećeg prstena (2039); pri čemu aktiviranje prve žice za povlačenje (2035) i druge žice za povlačenje (2036) uzrokuje pomicanje savitljive cijevi (2030) iz prve konfiguracije u drugu konfiguraciju; pri čemu, kada je savitljiva cijev (2030) u drugoj konfiguraciji, drugi savitljivi dio (116) tvori prvi zakrivljeni dio, a prvi savitljivi dio (115) tvori drugi zakrivljeni ravninski dio.
2. Kateter za isporuku (114) prema zahtjevu 1, naznačen time što je prvi greben (2040) konfiguriran tako da ograničava kompresivno kretanje između prvog prstena (2037) i drugog prstena (2038) kada se savitljiva cijev (2030) premješta u drugu konfiguraciju.
3. Kateter za isporuku (114) prema zahtjevu 2, naznačen time što je drugi greben (2041) konfiguriran tako da ograničava savijanje pomoću prve žice za povlačenje (2035) između drugog prstena (2038) i trećeg prstena (2039) kada se savitljiva cijev (2030) premješta u drugu konfiguraciju.
4. Kateter za isporuku (114) prema bilo kojem od prethodnih zahtjeva, naznačen time što su prvi greben (2040) i drugi greben (2041) izrađeni od tvrđeg materijala nego savitljiva cijev (2030).
5. Kateter za isporuku (114) prema bilo kojem od prethodnih zahtjeva, naznačen time što omjer Shore D tvrdoće prvog grebena (2040) prema Shore D tvrdoći drugog grebena (2041) iznosi između oko 1,5:1 i oko 6:1.
6. Kateter za isporuku (114) prema bilo kojem od prethodnih zahtjeva, naznačen time što savitljiva cijev (2030) sadrži Nitinol ili plastiku, pri čemu je savitljiva cijev (2030) poželjno čvrsta cijev.
7. Kateter za isporuku (114) prema bilo kojem od prethodnih zahtjeva, naznačen time što se prvi greben (2040) i drugi greben (2041) sastoje od nehrđajućeg čelika ili plastike.
8. Kateter za isporuku (114) prema bilo kojem od prethodnih zahtjeva, naznačen time što distalni dio (117) savitljive cijevi (2030) distalni dio savitljivi krajnji dio (108) distalno od prvog savitljivog dijela (115) pri čemu je savitljivi krajnji dio (108) radi postavljanja konfiguriran da se savija kako bi pomogao u pozicioniranju uređaja za sidrenje (1).
9. Kateter za isporuku (114) prema zahtjevu 8, naznačen time što kada je savitljiva cijev (2030) u drugoj konfiguraciji, savitljivi krajnji dio (108) je konfiguriran tako da bude pod kutom u odnosu na prvi savitljivi dio (115), pri čemu okomiti pomak između savitljivog krajnjeg dijela (108) i prvog savitljivog dijela (115) poželjno iznosi između oko 2 mm i oko 10 mm.
10. Kateter za isporuku (114) prema bilo kojem od prethodnih zahtjeva, naznačen time što dalje sadrži prvu namotanu čahuru (2211) koja se proteže oko najmanje dijela prve žice za povlačenje (2035) i drugu namotanu čahuru (2213) koja se proteže oko najmanje dijela druge žice za povlačenje (2036).
11. Kateter za isporuku (114) prema bilo kojem od prethodnih zahtjeva, naznačen time što je prva spojna točka (A) pomaknuta u obodnom smjeru od druge spojne točke (B) za oko 90 stupnjeva.
12. Kateter za isporuku (114) prema bilo kojem od prethodnih zahtjeva, naznačen time što je središte prvog grebena (2040) obodno pomaknuto od prve žice za povlačenje (2035) za približno 180 stupnjeva ili za između oko 70 stupnjeva i oko 110 stupnjeva.
13. Kateter za isporuku (114) prema bilo kojem od prethodnih zahtjeva, naznačen time što širina prvog grebena (2040) definira kut (θ) između oko 45 stupnjeva i oko 135 stupnjeva.
14. Kateter za isporuku (114) prema bilo kojem od prethodnih zahtjeva, naznačen time što je središte drugog grebena (2041) obodno pomaknuto od druge žice za povlačenje (2036) za približno 180 stupnjeva ili za između oko 70 stupnjeva i oko 110 stupnjeva.
15. Kateter za isporuku (114) prema bilo kojem od prethodnih zahtjeva, naznačen time što širina drugog grebena (2041) definira kut (β) između oko 45 stupnjeva i oko 135 stupnjeva.
HRP20230241TT 2016-12-16 2017-12-15 Sustavi za postavljanje i alati za isporuku uređaja za sidrenje za protetski zalistak HRP20230241T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662435563P 2016-12-16 2016-12-16
PCT/US2017/066854 WO2018112429A1 (en) 2016-12-16 2017-12-15 Deployment systems, tools, and methods for delivering an anchoring device for a prosthetic valve
EP17880012.4A EP3554424B1 (en) 2016-12-16 2017-12-15 Deployment systems and tools for delivering an anchoring device for a prosthetic valve

Publications (1)

Publication Number Publication Date
HRP20230241T1 true HRP20230241T1 (hr) 2023-04-14

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Country Link
US (3) US10940000B2 (hr)
EP (2) EP4218672A1 (hr)
JP (3) JP7440263B2 (hr)
CN (2) CN110072492B (hr)
AU (2) AU2017378495B2 (hr)
CA (1) CA3046974A1 (hr)
CR (1) CR20190219A (hr)
DK (1) DK3554424T3 (hr)
ES (1) ES2941260T3 (hr)
FI (1) FI3554424T3 (hr)
HR (1) HRP20230241T1 (hr)
HU (1) HUE061376T2 (hr)
PL (1) PL3554424T3 (hr)
PT (1) PT3554424T (hr)
SI (1) SI3554424T1 (hr)
WO (1) WO2018112429A1 (hr)

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JP2023159316A (ja) 2023-10-31
SI3554424T1 (sl) 2023-04-28
JP7440263B2 (ja) 2024-02-28
EP3554424A1 (en) 2019-10-23
US20180318079A1 (en) 2018-11-08
JP2023022180A (ja) 2023-02-14
EP4218672A1 (en) 2023-08-02
CN110072492B (zh) 2021-06-11
EP3554424B1 (en) 2022-12-28
FI3554424T3 (fi) 2023-03-30
PL3554424T3 (pl) 2023-05-08
AU2017378495A1 (en) 2019-05-23
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US10940000B2 (en) 2021-03-09
CN113288514A (zh) 2021-08-24
AU2023200645A1 (en) 2023-03-09
AU2017378495B2 (en) 2022-11-24
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