CA2450935A1 - Ensemble permettant la mise en place d'une valve prothetique dans un conduit corporel - Google Patents

Ensemble permettant la mise en place d'une valve prothetique dans un conduit corporel Download PDF

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Publication number
CA2450935A1
CA2450935A1 CA002450935A CA2450935A CA2450935A1 CA 2450935 A1 CA2450935 A1 CA 2450935A1 CA 002450935 A CA002450935 A CA 002450935A CA 2450935 A CA2450935 A CA 2450935A CA 2450935 A1 CA2450935 A1 CA 2450935A1
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Canada
Prior art keywords
stent
valve
assembly
wall
expansion
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002450935A
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English (en)
Other versions
CA2450935C (fr
Inventor
Jacques Seguin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic CoreValve LLC
Original Assignee
Jacques Seguin
Corevalve, Inc.
Medtronic Corevalve Llc
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Application filed by Jacques Seguin, Corevalve, Inc., Medtronic Corevalve Llc filed Critical Jacques Seguin
Publication of CA2450935A1 publication Critical patent/CA2450935A1/fr
Application granted granted Critical
Publication of CA2450935C publication Critical patent/CA2450935C/fr
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2403—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 pivoting rigid closure members
    • 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
    • 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
    • A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • 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
    • 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

Abstract

Cet ensemble (1) comprend la valve prothétique (4) à implanter et un stent (2). Selon l'invention, la valve (4) et le stent (2) sont conformés de telle sorte que la valve (4) est située, au moment où est réalisée l'expansion du stent (2), en dehors de la ou des zones (10, 11, 14) du stent (2) devant êtr e expansées.

Claims (21)

14~

REVENDICATIONS
1 - Ensemble permettant la mise en place d'une valve prothétique (4) dans un conduit corporel, notamment une valve cardiaque et en particulier une valve aortique, comprenant - la valve prothétique (4) à implanter;
- une armature (2) radialement expansible, dite "stent", comprenant au moins une zone (10, 11, 14) destinée à être expansée pour permettre à ce stent (2), à l'état expansé, de prendre appui contre la paroi du conduit corporel (100) à équiper, cette prise d'appui permettant d'immobiliser ce stent (2) par rapport à cette paroi; et - des moyens (25, 31 ; 50, 51) de montage de la valve (4) par rapport au stent (2), permettant de relier la valve (4) au stent (2) de telle sorte que la mise en place du stent (2) permette le montage de la valve (4) dans le conduit corporel (100), des moyens d'expansion tel qu'un cathéter à ballonnet étant prévus pour provoquer l'expansion du stent (2) au niveau du site d'implantation;
ensemble (1) caractérisé en ce que la valve (4) et le stent (2) sont conformés de telle sorte que la valve (4) est située, au moment où est réalisée l'expansion du stent (2), en dehors de la ou des zones (10, 11, 14) du stent (2) soumises auxdits moyens d'expansion.
2 - Ensemble (1) selon la revendication 1, caractérisé en ce que le stent (2) comprend une zone (12) de montage de la valve (4), qui est distincte de la ou des zones (10, 11, 14) du stent (2) à expanser, et en ce que lesdits moyens de montage (25, 31) relient la valve (4) à cette zone de montage (12).
3 - Ensemble (1) selon la revendication 2, caractérisé en ce que lesdits moyens de montage (25, 31) comprennent des conduits (31) aménagés dans, ou fixés sur, la paroi périphérique (30) de la valve (4) et des bras (25) aménagées sur le stent (2), ou inversement, la paroi périphérique (30) de la valve (4) pouvant être engagée et pouvant coulisser sur ces bras (25).
4 - Ensemble (1) selon la revendication 1, caractérisé en ce que lesdits moyens de montage (50, 51) sont conformés de telle sorte que la valve (4) est mobile axialement par rapport au stent (2) entre une position de non-implantation, dans laquelle elle se trouve en dehors de la ou des zones (10, 11, 14) du stent (2) devant être expansées, et une position d'implantation, qu'elle peut atteindre après expansion du stent (2) dans le conduit corporel (100), dans laquelle elle est immobilisée axialement par rapport au stent (2).
- Ensemble (1) selon la revendication 4, caractérisé en ce que lesdits moyens de montage (50, 51) comprennent une ou plusieurs des dispositions suivantes:
- des organes d'accrochage tels que des pointes, des crochets ou des griffes montés sur la valve, propres à être insérés dans la paroi délimitant ledit conduit corporel; ces organes d'accrochage peuvent être orientés radialement par rapport à la valve, de manière à pouvoir être insérés dans ladite paroi lors du déploiement radial de la valve, ou peuvent être orientés tangentiellement par rapport à la valve, de manière à pouvoir être insérés dans ladite paroi lors d'un pivotement de la valve autour de son axe ou lors d'un mouvement longitudinal par rapport au stent;
- des vésicules ruptibles remplies de colle biologique ou autre produit adhésif approprié, placées sur la face externe de la valve, ces vésicules étant propres à se rompre lorsque la valve est amenée dans sa position d'implantation, notamment par écrasement entre la valve et le stent;
- au moins un bandeau ou un fil circulaire ou hélicoïdal intégré dans la paroi périphérique de la valve, présentant une mémoire de forme telle qu'il maintient la valve plaquée contre le stent dans la position d'implantation de cette valve;
- des conduits aménagés dans, ou fixés sur, la paroi périphérique de la valve et des tiges aménagées sur le stent, ou inversement, ces tiges (53) pouvant être engagées et pouvant coulisser au travers de ces conduits (50) lors du passage de la valve (4) de sa position de non-implantation à sa position d'implantation, des moyens tels que des crochets pouvant être prévus pour immobiliser ces conduits (50) par rapport à ces tiges (53) dans ladite position d'implantation ; des fils (55) peuvent être reliés aux extrémités desdites tiges (53) et peuvent passer au travers desdits conduits (50), pour guider facilement ces tiges (53) dans ces conduits (50).
6 - Ensemble (1) selon la revendication 1, caractérisé en ce que les moyens (60) de montage de la valve (4) par rapport au stent (2) sont conformés de manière à permettre, au-delà d'un seuil d'expansion du stent, une expansion différente de la valve (4) et du stent (2), de sorte qu'une variation dans le degré d'expansion du stent (2) n'a pas d'incidence sur le degré d'expansion de la valve (4).
7 - Ensemble (1) selon l'une des revendications 1 à 6, caractérisé
en ce que le stent (2) et/ou la valve (4) comprennent un ou plusieurs éléments (60) limitant le diamètre final de la valve (4) notamment au niveau des points commissuraux des valvules de celle-ci.
8 - Ensemble (1) selon l'une des revendications 1 à 7, caractérisé
en ce que la valve (4) présente une paroi périphérique (30) d'un diamètre non constant dans le sens axial, notamment une forme tronconique dont le diamètre se réduit dans la direction distale, et en ce que la zone (12) du stent (2) destinée à recevoir cette paroi périphérique (30) de la valve (4) présente une forme correspondant à celle de cette paroi périphérique (30).
9 - Ensemble (1) selon l'une des revendications 1 à 8, caractérisé
en ce que le stent (2) présente une portion médiane de diamètre plus réduit que ses portions d'extrémité, notamment en deux troncs de cône inversés ou en diabolo, la valve présentant une forme correspondant à la zone du stent au niveau de laquelle elle est destinée à être montée.
- Ensemble (1) selon l'une des revendications 1 à 9, caractérisé
en ce que:
- la valve (4) présente une paroi périphérique (30);
- le stent (2) présente, dans le prolongement, du côté distal, de la zone (12) du stent (2) destinée à recevoir la valve (4), une portion rabattable (45); cette portion rabattable (45) est mobile entre une position étendue, dans laquelle elle se trouve dans le prolongement de ladite zone (12) du côté
distal, et une position rabattue, dans laquelle elle est placée contre la face interne de la paroi périphérique (30) de la valve (4) et emprisonne cette paroi périphérique (30) entre elle et ladite zone (12) du stent (2), et - des moyens de maintien (46) sont prévus pour maintenir cette portion rabattable (45) dans cette position rabattue.
11 - Ensemble (1) selon la revendication 10, caractérisé en ce que lesdits moyens de maintien sont constitués par un fil (46) en un matériau rigide mais présentant un degré de souplesse élastique, tel qu'un matériau métallique, ayant une forme ondulée et s'étendant sur l'ensemble de la circonférence de ladite portion rabattable (45).
12 - Ensemble (1) selon l'une des revendications 1 à 11, caractérisé en ce que le stent (2) comprend une gaine (3) en un matériau biocompatible imperméable, le recouvrant au moins partiellement.
13 - Ensemble (1) selon la revendication 12, pour la mise en place d'une valve aortique, caractérisé en ce que la gaine présente des ouvertures latérales (61), propres à venir en regard des ostia coronaires (101) au moment de l'implantation.
14 - Ensemble (1) selon la revendication 12 ou la revendication 13, caractérisé en ce que, dans le cas où il comprend ladite portion rabattable (45), cette portion rabattable (45) est constituée par un prolongement de la gaine (3), qui forme un manchon au-delà de ladite zone (12) du stent (2) destinée à
recevoir la valve (4).
15 - Ensemble (1) selon l'une des revendications 12 à 14, caractérisé en ce que le stent (2) présente, fixée sur ladite gaine (3), au moins une chambre périphérique gonflable (41, 43), pouvant être gonflée de manière à former un joint assurant l'étanchéité entre le stent (2) et la paroi du conduit corporel (100) à équiper.
16 - Ensemble (1) selon la revendication 15, caractérisé en ce que le stent (2) présente deux chambres périphériques gonflables (41, 43) placées de part et d'autre de la portion (11) du stent (2) destinée à prendre appui contre un anneau valvulaire cardiaque (103).
17 - Ensemble (1) selon l'une des revendications 1 à 16, caractérisé en ce que le stent (2) présente une portion cylindrique (11), propre à prendre appui contre un anneau valvulaire cardiaque (103), et une portion distale (12), reliée à cette portion cylindrique (11).
18 - Ensemble (1) selon l'une des revendications 1 à 17, caractérisé en ce que le stent (2) présente une portion proximale (10) tronconique ou évasée, dont le diamètre va en se réduisant dans la direction distale, propre, dans le cas de l'implantation d'une valve (4) cardiaque, à
prendre appui contre la paroi (102) du ventricule ou de l'oreillette correspondante du coeur.
19 - Ensemble (1) selon la revendication 17 ou la revendication 18, caractérisé en ce que le stent (2) présente une portion supplémentaire d'appui (10) reliée par des tiges filiformes (13) à ladite portion distale (12) ou à
ladite portion cylindrique (11), ces tiges filiformes (13) ayant des longueurs telles que cette portion supplémentaire d'appui (10) est placée au-delà des ostia coronaires.
20 - Ensemble (1) selon l'une des revendications 1 à 19, caractérisé en ce que le stent (2) présente des crochets (15) mobiles entre une position de retrait, qu'ils occupent avant expansion du stent (2), et une position de déploiement, dans laquelle ils sont amenés lors du déploiement du stent (2) et dans laquelle ils sont insérés dans une paroi (103, 100) délimitant le conduit corporel.
21 - Ensemble (1) selon l'une des revendications 1 à 20, caractérisé en ce que le stent (2) présente une portion (10) proche, en regard ou sur l'anneau valvulaire (103), ayant une force radiale élevée.
CA2450935A 2001-07-04 2002-07-04 Ensemble permettant la mise en place d'une valve prothetique dans un conduit corporel Expired - Fee Related CA2450935C (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR0108898A FR2826863B1 (fr) 2001-07-04 2001-07-04 Ensemble permettant la mise en place d'une valve prothetique dans un conduit corporel
FR01/08898 2001-07-04
PCT/FR2002/002352 WO2003003949A2 (fr) 2001-07-04 2002-07-04 Ensemble permettant la mise en place d'une valve prothetique dans un conduit corporel

Publications (2)

Publication Number Publication Date
CA2450935A1 true CA2450935A1 (fr) 2003-01-16
CA2450935C CA2450935C (fr) 2010-09-21

Family

ID=8865140

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2450935A Expired - Fee Related CA2450935C (fr) 2001-07-04 2002-07-04 Ensemble permettant la mise en place d'une valve prothetique dans un conduit corporel

Country Status (10)

Country Link
US (5) US7252682B2 (fr)
EP (1) EP1401359B1 (fr)
JP (1) JP4364633B2 (fr)
AT (1) ATE440567T1 (fr)
AU (1) AU2002329324B2 (fr)
CA (1) CA2450935C (fr)
DE (1) DE60233493D1 (fr)
ES (1) ES2335651T3 (fr)
FR (1) FR2826863B1 (fr)
WO (1) WO2003003949A2 (fr)

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US7780726B2 (en) 2010-08-24
US20100036485A1 (en) 2010-02-11
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JP2005505320A (ja) 2005-02-24
US20080215143A1 (en) 2008-09-04
US8628570B2 (en) 2014-01-14
JP4364633B2 (ja) 2009-11-18
DE60233493D1 (de) 2009-10-08
FR2826863B1 (fr) 2003-09-26
US9149357B2 (en) 2015-10-06
CA2450935C (fr) 2010-09-21
US20140188220A1 (en) 2014-07-03
US7252682B2 (en) 2007-08-07
AU2002329324B2 (en) 2007-07-12
WO2003003949A3 (fr) 2004-01-22
EP1401359B1 (fr) 2009-08-26
ATE440567T1 (de) 2009-09-15
FR2826863A1 (fr) 2003-01-10
WO2003003949A2 (fr) 2003-01-16
ES2335651T3 (es) 2010-03-31
US8002826B2 (en) 2011-08-23
US20050043790A1 (en) 2005-02-24

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