WO2007071436B1 - Stent-valves for valve replacement and associated methods and systems for surgery - Google Patents

Stent-valves for valve replacement and associated methods and systems for surgery

Info

Publication number
WO2007071436B1
WO2007071436B1 PCT/EP2006/012455 EP2006012455W WO2007071436B1 WO 2007071436 B1 WO2007071436 B1 WO 2007071436B1 EP 2006012455 W EP2006012455 W EP 2006012455W WO 2007071436 B1 WO2007071436 B1 WO 2007071436B1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
stent
component
catheter
occluder
Prior art date
Application number
PCT/EP2006/012455
Other languages
French (fr)
Other versions
WO2007071436A2 (en
WO2007071436A3 (en
Inventor
Segesser Ludwig K Von
Stephane Delaloye
Original Assignee
Symetis Sa
Segesser Ludwig K Von
Stephane Delaloye
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
Application filed by Symetis Sa, Segesser Ludwig K Von, Stephane Delaloye filed Critical Symetis Sa
Priority to JP2008546277A priority Critical patent/JP2009520535A/en
Priority to DE602006015356T priority patent/DE602006015356D1/en
Priority to CA002634358A priority patent/CA2634358A1/en
Priority to MX2008008068A priority patent/MX2008008068A/en
Priority to EP06841127A priority patent/EP1968491B1/en
Priority to CN2006800529220A priority patent/CN101374477B/en
Priority to EP18158901.1A priority patent/EP3398560B8/en
Priority to AT06841127T priority patent/ATE472985T1/en
Priority to BRPI0620302-7A priority patent/BRPI0620302A2/en
Priority to AU2006328896A priority patent/AU2006328896B2/en
Publication of WO2007071436A2 publication Critical patent/WO2007071436A2/en
Publication of WO2007071436A3 publication Critical patent/WO2007071436A3/en
Publication of WO2007071436B1 publication Critical patent/WO2007071436B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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    • 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
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    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
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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
    • 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
    • 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
    • A61F2230/0073—Quadric-shaped
    • A61F2230/0078—Quadric-shaped hyperboloidal
    • 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
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a 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
    • A61F2250/0014—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

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Reproductive Health (AREA)
  • Mechanical Engineering (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Stent-valves (e.g., single-stent-valves and double-stent-valves), associated methods and systems for their delivery via minimally-invasive surgery, and guide-wire compatible closure devices for sealing access orifices are provided.

Claims

AMENDED CLAIMS received by the International Bureau on 27 November 2007 (27.11.2007)WE CLAIM:
1. A replacement valve for use within a human body comprising: a valve component; and a stent component comprising a first section, a second section for housing the valve component, and a third section, wherein the first section comprises an annular groove.
2. The replacement valve of claim 1, wherein the annular groove is configured to receive and secure circumferentially to an annulus of the valve in need of replacement.
3. The replacement valve of claim I5 further comprising a second stent component comprising an annular projection, wherein the annular projection is configured for matable attachment to the annular groove when the stent component is positioned within the second stent component.
4. The replacement valve of claim 1, wherein the valve component comprises a biological valve.
5. The replacement valve of claim 1 , wherein the valve component comprises a synthetic valve.
6. The replacement valve of claim 1 , wherein the stent component is self- expandable.
7. The replacement valve of claim 1, wherein the second section of the stent component follows a contour of the valve component.
45
8. The replacement valve of claim 1 , wherein the second region comprises at least one locking element protruding outwardly from an outer surface of the second region.
9. The replacement valve of claim 8, wherein the second region comprises a plurality of locking elements that protrude outwardly from the outer surface of the second region and wherein at least two of the plurality of locking elements are positioned at different positions along a central axis of the stent component.
10. A replacement valve for use within a human body comprising: a valve component; and at least two stent components affixed to one another comprising: a first section comprising a first cone or crown and a second stent structure collectively forming a fixation element; and a second section configured to house the valve component
11. The replacement valve of claim 10, wherein the second stent structure comprises a cone or a crown.
12. The replacement valve of claim 10, wherein the second stent structure comprises a plurality of locking elements protruding outwardly from an outer surface of the first section and wherein at least two of the plurality of locking elements are positioned at different vertical positions along a central axis of the first section.
13. A method for replacing a failed cardiac valve comprising: providing a stent-valve comprising a valve component and a stent component, wherein the stent component comprises an annular groove; and securing the annular groove axially to an annulus of the valve.
14. The method of claim 13, wherein providing a stent-valve comprises expanding the valve component within the stent component in order to form a friction fitting.
46
15. The method of claim 13, wherein providing a stent-valve comprises securing the valve component to the stent component with a hook-and-loop fastening system.
16. A method for replacing a worn or diseased cardiac valve comprising: implanting a first stent component comprising an annular element, wherein at least a portion of the stent component is housed within the worn or diseased valve; and positioning a stent-valve comprising a second stent component and a valve component within the first stent component, wherein the second stent component comprises a complimentary annular element for matably attaching to the first stent component.
17. An occluder for sealing an orifice in tissue comprising: a first portion capable of expansion from a collapsed configuration on a luminal side of the orifice to an expanded configuration; and a second portion capable of expansion from a collapsed configuration to an expanded configuration on a side of the orifice opposite to the luminal side, wherein said first portion and said second portion form a central, hollow channel for housing a guide wire.
18. The occluder of claim 17, further comprising a connector for connecting the occluder to a catheter.
19. The occluder of claim 18, wherein the connector comprises a hollow screw mechanism for connecting the catheter to a threaded catheter.
20. The occluder of claim 18, further comprising a second catheter for housing the occluder for delivery to the tissue orifice.
21. The occluder of claim 17, wherein the first portion of the occluder further comprises a channel sealing mechanism for preventing blόod-flow from the luminal side of the tissue orifice.
47
22. The occluder of claim 21 , wherein the channel sealing mechanism comprises at least one of a membrane and foam.
23. The occluder of claim 21, wherein the channel sealing mechanism comprises a valve.
24. The occluder of claim 17, wherein the top portion of the occluder comprises a first material and the bottom portion of the occluder comprises a second material, wherein the second material is coarser than the first material.
25. A method for sealing an orifice in tissue, comprising: connecting an expandable and collapsible occlusion device to a first catheter, the occlusion device comprising (i) a first portion capable of expansion from a collapsed configuration to an expanded configuration and a second portion capable of expansion from a collapsed configuration to an expanded configuration,
(ii) a central channel for housing a guide wire, and (iii) a connector for connecting the occluder device to the first catheter; inserting the occlusion device into a second catheter in a collapsed condition; receiving, by the first catheter and central channel, a guide wire; positioning the second catheter in the orifice, such that a first end of the second catheter is positioned on a luminal side of the orifice; and causing relative movement between the collapsed occlusion device and the second catheter to move the occlusion device out of the second catheter, wherein upon the occlusion device emerging from the first end of the second catheter, the first portion of the occlusion device expands on the luminal side of the orifice and wherein upon the occlusion device being completely emerged from the second catheter, the second portion expands.
26. The method of claim 25, wherein the tissue orifice comprises a tissue orifice in the left ventricle of the heart, and the positioning the second catheter in the tissue orifice comprises delivering the second catheter to the left ventricle via an intercostal space.
49
PCT/EP2006/012455 2005-12-22 2006-12-22 Stent-valves for valve replacement and associated methods and systems for surgery WO2007071436A2 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
JP2008546277A JP2009520535A (en) 2005-12-22 2006-12-22 Valve replacement stent valves and related surgical methods and systems
DE602006015356T DE602006015356D1 (en) 2005-12-22 2006-12-22 STENT VALVES AS FLAPS AND RELEVANT PROCEDURES AND OPERATING SYSTEMS
CA002634358A CA2634358A1 (en) 2005-12-22 2006-12-22 Stent-valves for valve replacement and associated methods and systems for surgery
MX2008008068A MX2008008068A (en) 2005-12-22 2006-12-22 Stent-valves for valve replacement and associated methods and systems for surgery.
EP06841127A EP1968491B1 (en) 2005-12-22 2006-12-22 Stent-valves for valve replacement and associated methods and systems for surgery
CN2006800529220A CN101374477B (en) 2005-12-22 2006-12-22 Stent-valves for valve replacement and associated methods and systems for surgery
EP18158901.1A EP3398560B8 (en) 2005-12-22 2006-12-22 Systems for surgery and stent valves for replacement
AT06841127T ATE472985T1 (en) 2005-12-22 2006-12-22 STENT VALVE AS VALVE REPLACEMENT AND RELEVANT PROCEDURES AND OPERATIONAL SYSTEMS
BRPI0620302-7A BRPI0620302A2 (en) 2005-12-22 2006-12-22 valve replacement stent valves and associated methods and surgery systems
AU2006328896A AU2006328896B2 (en) 2005-12-22 2006-12-22 Stent-valves for valve replacement and associated methods and systems for surgery

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US75307105P 2005-12-22 2005-12-22
US60/753,071 2005-12-22
US75559005P 2005-12-29 2005-12-29
US60/755,590 2005-12-29
US84318106P 2006-09-07 2006-09-07
US60/843,181 2006-09-07

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WO2007071436A2 WO2007071436A2 (en) 2007-06-28
WO2007071436A3 WO2007071436A3 (en) 2007-11-15
WO2007071436B1 true WO2007071436B1 (en) 2008-01-17

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MX (1) MX2008008068A (en)
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