WO1997025001A1 - Aortoiliac endoprosthesis - Google Patents

Aortoiliac endoprosthesis Download PDF

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Publication number
WO1997025001A1
WO1997025001A1 PCT/FR1997/000005 FR9700005W WO9725001A1 WO 1997025001 A1 WO1997025001 A1 WO 1997025001A1 FR 9700005 W FR9700005 W FR 9700005W WO 9725001 A1 WO9725001 A1 WO 9725001A1
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WO
WIPO (PCT)
Prior art keywords
sleeves
tube
stent
aortoiliac
abdominal aorta
Prior art date
Application number
PCT/FR1997/000005
Other languages
French (fr)
Inventor
Jean Marc Denis
Original Assignee
Jean Marc Denis
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 Jean Marc Denis filed Critical Jean Marc Denis
Priority to EP97900223A priority Critical patent/EP0873093A1/en
Publication of WO1997025001A1 publication Critical patent/WO1997025001A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/061Blood vessels provided with means for allowing access to secondary lumens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/065Y-shaped blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/065Y-shaped blood vessels
    • A61F2002/067Y-shaped blood vessels modular
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • A61F2002/075Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8486Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs provided on at least one of the ends
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular 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
    • A61F2210/0019Particular 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 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008Fixation appliances for connecting prostheses to the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0034D-shaped

Definitions

  • the present invention relates to an aortoiliac stent for the treatment, for example, of aortic or aortoiliac aneurysms.
  • the treatment is fairly delicate and requires fairly long anesthesia.
  • the treatment is carried out without surgical intervention.
  • the stents are introduced at a distance from the pathological area and positioned using a radiological installation.
  • the principle is to bring the prosthesis or endoprosthesis to the site from an external femoral or iliac access, that is to say superficial and not very traumatic.
  • the object of the present invention is to improve the endoluminal treatments in order to facilitate the placement of stents at the level of the aortic or aorto-bi-iliac aneurysm.
  • the aorto-iliac endoprosthesis according to the present invention comprises two tubes capable of deforming elastically in all directions and each end of which is integral with a mesh sleeve provided with attachment means, while said tubes have a conical profile so that their upper ends are of a larger diameter than that of their lower ends and that said sleeves are made of a bio-compatible metallic material, deformable and with shape memory.
  • Figure 1 is a schematic view showing the abdominal aorta provided with its various arteries.
  • Figure 2 is a perspective view illustrating the aortoiliac stent according to the present invention.
  • Figure 3 is a view showing the positioning of the aortoiliac stent within the wall of the abdominal aorta.
  • Figure 4 is a view similar to that of Figure 3, but showing a variant implementation of the aorto-iliac stent.
  • Figures 5 and 6 are enlarged sections along V-V of Figure 3 and VI-VI of Figure 4 of the abdominal aorta at the upper fixation of the aortoiliac stent.
  • FIG. 1 There is shown diagrammatically in FIG. 1 an abdominal aorta 1 dividing into a first artery 1a called “left primary iliac artery” and into a second artery 1b called “right primary iliac artery”.
  • the abdominal aorta 1 has above the iliac arteries 1a and 1b a lower mesenteric artery 1c, a left renal artery 1d and a right renal artery 1e.
  • the left primary iliac artery 1a is extended by a left external iliac artery 1g and by a left internal iliac artery 1i.
  • the right primary iliac artery 1b is extended by a right external iliac artery 1h and by a right internal iliac artery 1j.
  • an aneurysm profile 1f of the abdominal aorta 1 which is located below the renal arteries 1d and 1e and which can extend over the primary iliac arteries 1a and 1b has been shown in dashed lines.
  • an aortoiliac stent 2 comprising two similar tubes 2a and of the same configuration.
  • Each tube 2a is made of a bio-compatible material to avoid any rejection from neighboring living organs.
  • the tubes 2a are provided with sufficient flexibility and elastic deformation in all their directions.
  • the material preferably used for the manufacture of the tubes can for example be of the type called under the name "DACRON".
  • the tubes 2a are provided with an adequate length to respond to the treatment of aneurysms of the abdominal aorta 1 situated between the renal arteries 1d, 1e and the primary iliac arteries 1a, 1b.
  • each tube 2a has a conical profile so that the upper ends 2b are of a larger diameter than that of the lower ends 2c.
  • the upper ends 2b cooperate respectively with a mesh sleeve 3.
  • Each lower end 2c is connected to a mesh sleeve 4 of diameter smaller than that of the sleeves 3.
  • the sleeves 3, 4 are provided in a metal alloy with shape memory.
  • Each sleeve 3, 4 comprises, for example, small hooks 5, directed in direction from the outside and evenly distributed around the periphery of each sleeve.
  • Each mesh sleeve 3, 4 penetrates inside the upper 2b and lower 2c ends of each tube 2a to extend the latter in their longitudinal direction.
  • the hooks 5 are integral with the free ends of each sleeve 3, 4, that is to say those protruding at the end of each tube2a.
  • the endoprosthesis 2 is introduced inside the abdominal aorta 1 by the endoluminal route, that is to say by means of a particular bag device described in a patent application belonging to the Applicant.
  • each tube 2a, integral with its sleeves 3, 4 is introduced by a bag device into the left external iliac artery 1g and right 1h respectively or the corresponding common femoral until its upper end 2b secured to the sleeve 3 is placed below the renal arteries 1d, 1e, while its lower end 2c provided with its sleeve 4 cooperates, depending on the operating case, with the primary iliac artery 1a, 1b or with the external iliac artery 1g, 1 h ( Figure 3).
  • the upper ends 2b are deformed by means of special pocket devices so that the mesh sleeves 3 press each tube 2a against the internal wall of the abdominal aorta 1. It is noted that the hooks 5 of each sleeve 3 penetrate the wall internal of the abdominal aorta to improve the anchoring of the endoprosthesis 2.
  • the lower ends 2c are deformed by means of special pocket devices so that the mesh sleeves 4 of each tube 2a are pressed against the internal wall of the primary iliac artery 1a, 1b or against the internal wall of the external iliac artery 1g, 1h. It then suffices to remove the devices with particular bags to allow blood circulation to pass through the stent 2 and to permanently relieve the abdominal aorta 1 to prevent any rupture of the aneurysm 1f.
  • each tube 2a is secured to a sleeve 3 having the same configuration as those described above. It is noted that each sleeve 3 is in this case partially engaged inside the corresponding tube 2a. In fact, this solution is provided when the aneurysm 1f rises near the renal arteries 1d and 1e, thus eliminating part of the abdominal aorta 1 for fixing the stent 2. In this case, the sleeves 3 must come fix above the renal arteries 1d and 1e without the upper end 2b of each tube 2a obstructing them.
  • the sleeves 3 are deformed in the same manner as above, but the hooks 5 are fixed in the internal wall of the abdominal aorta 1 and above the renal arteries 1d and 1e, while the upper ends 2b of each tube 2a are located below the renal arteries 1d and 1e.
  • the configuration of the sleeves 3 allows the flow of blood flow in the renal arteries 1d and 1e and this without obstructing them.
  • each tube 2a adapted to the lower end 2c may be engaged only partially so as to be able to anchor in the estiac iliac artery 1g, 1h without preventing the passage of blood flow in the other internal iliac artery 1i, 1d.
  • Each wire constituting the mesh of the sleeves 3 and 4 has a surface condition suitable for ensuring sufficient anchoring either inside each tube 2a, or inside each artery.
  • the tubes 2a of the stent 2 can cross without influencing the method of fixing said stent.

Abstract

An aortoiliac endoprosthesis including two tapering tubes (2a) capable of being bent in all directions so that the upper tube ends (2b) have a greater diameter than the lower tube ends (2c), while sleeves (3, 4) are secured to each of the ends (2b, 2c). The sleeves (3, 4) are provided with hook means (5) for retaining the endoprosthesis (2), and made of a biocompatible, flexible shape-memory metal material.

Description

ENDOPROTHESE AORTO-ILIAQUE AORTO-ILIAC ENDOPROSTHESIS
La présente invention a trait à une endoprothèse aorto-iliaque pour le traitement, par exemple, des anévrismes aortiques ou aorto-iliaques sous-rénaux.The present invention relates to an aortoiliac stent for the treatment, for example, of aortic or aortoiliac aneurysms.
A ce jour, les traitement des anévrismes aortiques ou aorto-iliaques sous rénaux sont réalisés par voie chirurgicale, soit par voie endoluminale.To date, the treatment of aortic or aorto-iliac aneurysms under renal are carried out by surgical way, either by endoluminal way.
Dans le premier cas, c'est à dire par voie chirurgicale, le traitement est assez délicat et nécessite des anesthésiés assez longues. De manière succinte, on procède à une intervention au niveau de l'anévrisme pour mettre en place une prothèse aortique. II faut tout d'abord disposer des pinces supérieure et inférieure de part et d'autre de l'anévrisme. Ensuite, on coupe l'artère au niveau de l'anévrisme pour permettre la mise en place de la prothèse qui est suturée à chaque extrémité de l'artère. Enfin, la pothèse est enveloppée dans l'épaisseur de l'artère pour isoler des éléments vivants voisins. La circulation sanguine est ensuite réalisée par le retrait des pinces et le chirurgien procède à la fermeture de tous les éléments vivants annexes. On note que cette opération est très délicate pour les personnes âgées et l'on rencontre à long terme des ennuis pariétaux, c'est à dire des risques d'éventration.In the first case, that is to say by surgery, the treatment is fairly delicate and requires fairly long anesthesia. Briefly, we proceed to an aneurysm intervention to put in place an aortic prosthesis. It is first necessary to have the upper and lower clamps on either side of the aneurysm. Then, the artery is cut at the aneurysm to allow the placement of the prosthesis which is sutured at each end of the artery. Finally, the prosthesis is wrapped in the thickness of the artery to isolate neighboring living elements. The blood circulation is then carried out by removing the forceps and the surgeon proceeds to close all of the living ancillary elements. It is noted that this operation is very delicate for the elderly and there are long-term parietal problems, that is to say risks of eventration.
Dans le second cas, le traitement est réalisé sans intervention chirurgicale. En effet, les endoprothèses sont introduites à distance de la zone pathologique et positionnées à l'aide d'une installation radiologique. Le principe est d'amener la prothèse ou l'endoprothèse sur les lieux à partir d'un accès fémoral ou iliaque externe, c'est à dire superficiel et peu traumatisant. La présente invention a pour but de perfectionner les traitements par voie endoluminale afin de faciliter la pose des endoprothèses au niveau de l'anévrisme aortique ou aorto-bi-iliaque.In the second case, the treatment is carried out without surgical intervention. Indeed, the stents are introduced at a distance from the pathological area and positioned using a radiological installation. The principle is to bring the prosthesis or endoprosthesis to the site from an external femoral or iliac access, that is to say superficial and not very traumatic. The object of the present invention is to improve the endoluminal treatments in order to facilitate the placement of stents at the level of the aortic or aorto-bi-iliac aneurysm.
L'endoprothèse aorto-iliaque suivant la présente invention comprend deux tubes susceptibles de se déformer éiastiquement dans toutes les directions et dont chaque extrémité est solidaire d'un manchon grillagé muni de moyens d'accrochage, tandis que lesdits tubes présentent un profil conique afin que leurs extrémités supérieures soient d'un diamètre plus important que celui de leurs extrémités inférieures et que lesdits manchons sont réalisés dans une matière métallique bio-compatible, déformable et à mémoire de forme.The aorto-iliac endoprosthesis according to the present invention comprises two tubes capable of deforming elastically in all directions and each end of which is integral with a mesh sleeve provided with attachment means, while said tubes have a conical profile so that their upper ends are of a larger diameter than that of their lower ends and that said sleeves are made of a bio-compatible metallic material, deformable and with shape memory.
Le dessin annexé, donné à titre d'exemple, permettra de mieux comprendre l'invention, les caractéristiques qu'elle présente et les avantages qu'elle est susceptible de procurer:The appended drawing, given by way of example, will allow a better understanding of the invention, the characteristics which it presents and the advantages which it is capable of providing:
Figure 1 est une vue schématique représentant l'aorte abdominale munie de ses différentes artères.Figure 1 is a schematic view showing the abdominal aorta provided with its various arteries.
Figure 2 est une vue en perspective illustrant l'endoprothèse aorto-iliaque suivant la présente invention. Figure 3 est une vue représentant la positionnement de l'endoprothèse aorto-iliaque à l'intérieur de ia paroi de l'aorte abdominale.Figure 2 is a perspective view illustrating the aortoiliac stent according to the present invention. Figure 3 is a view showing the positioning of the aortoiliac stent within the wall of the abdominal aorta.
Figure 4 est une vue semblable à celle de figure 3, mais représentant une variante de mise en place de l'endoprothèse aorto-iliaque.Figure 4 is a view similar to that of Figure 3, but showing a variant implementation of the aorto-iliac stent.
Figures 5 et 6 sont des coupes à plus grande échelle suivant V-V de figure 3 et VI-VI de figure 4 de l'aorte abdominale au niveau de la fixation supérieure de l'endoprothèse aorto-iliaque.Figures 5 and 6 are enlarged sections along V-V of Figure 3 and VI-VI of Figure 4 of the abdominal aorta at the upper fixation of the aortoiliac stent.
On a représenté schematiquement en figure 1 une aorte abdominale 1 se séparant en une première artère 1a dite « artère iliaque primitive gauche » et en une seconde artère 1b dite « artère iliaque primitive droite ». L'aorte abdominale 1 comporte au dessus des artères iliaques 1a et 1b une artère mésentérique inférieure 1c, une artère rénale gauche 1d et une artère rénale droite 1e. L'artère iliaque primitive gauche 1a se prolonge par une artère iliaque externe gauche 1g et par une artère iliaque interne gauche 1i. Egalement, l'artère iliaque primitive droite 1b se prolonge par une artère iliaque externe droite 1h et par une artère iliaque interne droite 1j.There is shown diagrammatically in FIG. 1 an abdominal aorta 1 dividing into a first artery 1a called “left primary iliac artery” and into a second artery 1b called “right primary iliac artery”. The abdominal aorta 1 has above the iliac arteries 1a and 1b a lower mesenteric artery 1c, a left renal artery 1d and a right renal artery 1e. The left primary iliac artery 1a is extended by a left external iliac artery 1g and by a left internal iliac artery 1i. Also, the right primary iliac artery 1b is extended by a right external iliac artery 1h and by a right internal iliac artery 1j.
On a montré en traits mixtes un exemple de profil d'anévrisme 1f de l'aorte abdominale 1 qui se situe en dessous des artères rénales 1d et 1e et qui peut se prolonger sur les artères iliaques primitives 1a et 1b. En figure 2, on a représenté une endoprothèse aorto-iliaque 2 comprenant deux tubes 2a semblables et de même configuration. Chaque tube 2a est réalisé dans une matière bio-compatible pour éviter tout rejet de la part des organes vivants voisins. Les tubes 2a sont prévus suffisamment souples et déformables éiastiquement suivant toutes leurs directions. La matière préférablement utilisée pour la fabrication des tubes peut être par exemple du type dénomé sous l'appelation « DACRON ».An example of an aneurysm profile 1f of the abdominal aorta 1 which is located below the renal arteries 1d and 1e and which can extend over the primary iliac arteries 1a and 1b has been shown in dashed lines. In Figure 2, there is shown an aortoiliac stent 2 comprising two similar tubes 2a and of the same configuration. Each tube 2a is made of a bio-compatible material to avoid any rejection from neighboring living organs. The tubes 2a are provided with sufficient flexibility and elastic deformation in all their directions. The material preferably used for the manufacture of the tubes can for example be of the type called under the name "DACRON".
On constate que les tubes 2a sont prévus d'uen longueur adéquate pour répondre aux traitements des anévrismes de l'aorte abdominale 1 situés entre les artères rénales 1d, 1e et les artères iliaques primitives 1a, 1b.It can be seen that the tubes 2a are provided with an adequate length to respond to the treatment of aneurysms of the abdominal aorta 1 situated between the renal arteries 1d, 1e and the primary iliac arteries 1a, 1b.
Pour cela, chaque tube 2a présente un profil conique afin que les extrémités supérieures 2b, soient d'un diamètre plus important que celui des extrémités inférieures 2c.For this, each tube 2a has a conical profile so that the upper ends 2b are of a larger diameter than that of the lower ends 2c.
Les extrémités supérieures 2b coopèreent respectivement avec un manchon grillagé 3. Chaque extrémité inférieure 2c est reliée à un manchon grillagé 4 de diamètre inférieur à celui des manchons 3. Les manchons 3, 4 sont prévus dans un alliage métallique à mémoire de forme. Chaque manchon 3, 4 comporte, par exemple, des petits crochets 5, dirigés en direction de l'extérieur et régulièrement répartis sur le pourtour de chaque manchon. Chaque manchon grillagé 3, 4 pénètre à l'intérieur des extrémités supérieure 2b et inférieure 2c de chaque tube 2a pour prolonger ces derniers suivant leur direction longitudinale. Les crochets 5 sont solidaires des extrémités libres de chaque manchon 3, 4, c'est à dire celles dépassant à l'extrémité de chaque tube2a.The upper ends 2b cooperate respectively with a mesh sleeve 3. Each lower end 2c is connected to a mesh sleeve 4 of diameter smaller than that of the sleeves 3. The sleeves 3, 4 are provided in a metal alloy with shape memory. Each sleeve 3, 4 comprises, for example, small hooks 5, directed in direction from the outside and evenly distributed around the periphery of each sleeve. Each mesh sleeve 3, 4 penetrates inside the upper 2b and lower 2c ends of each tube 2a to extend the latter in their longitudinal direction. The hooks 5 are integral with the free ends of each sleeve 3, 4, that is to say those protruding at the end of each tube2a.
L'endoprothèse 2 est introduite à l'intérieur de l'aorte abdominale 1 par voie endoluminale, c'est à dire au moyen d'un dispositif à poches particulier décrit dans une demande de brevet appartenant au Demandeur.The endoprosthesis 2 is introduced inside the abdominal aorta 1 by the endoluminal route, that is to say by means of a particular bag device described in a patent application belonging to the Applicant.
En effet, chaque tube 2a, solidaire de ses manchons 3, 4 est introduit par un dispositif à poches dans respectivement l'artère iliaque externe gauche 1g et droite 1 h ou la fémorale communue correspondante jusqu'à ce que son extrémité supérieure 2b solidaire du manchon 3 soit placée en dessous des artères rénales 1d, 1e, tandis que son extrémité inférieure 2c munie de son manchon 4 coopère, suivant le cas opératoire, avec l'artère iliaque primitive 1a, 1b ou avec l'artère iliaque externe 1g, 1 h (figure 3).Indeed, each tube 2a, integral with its sleeves 3, 4 is introduced by a bag device into the left external iliac artery 1g and right 1h respectively or the corresponding common femoral until its upper end 2b secured to the sleeve 3 is placed below the renal arteries 1d, 1e, while its lower end 2c provided with its sleeve 4 cooperates, depending on the operating case, with the primary iliac artery 1a, 1b or with the external iliac artery 1g, 1 h (Figure 3).
Les extrémités supérieures 2b sont déformées au moyen des dispositifs à poches particuliers de manière que les manchons grillagés 3 viennent plaquer chaque tube 2a contre la paroi interne de l'aorte abdominale 1. On remarque que les crochets 5 de chaque manchon 3 pénètrent dans la paroi interne de l'aorte abdominale pour améliorer l'ancrage de l'endoprothèse 2. De même, les extrémité inférieures 2c sont déformées au moyen des dispositifs à poches particuliers de manière que les manchons grillagé 4 de chaque tube 2a viennent plaquer contre la paroi interne de l'artère iliaque primitive 1a, 1b ou contre la paroi interne de l'artère iliaque externe 1g, 1h. II suffit ensuite de retirer les dispositifs à poches particuliers pour permettre à la circulation sanguine de traverser l'endoprothèse 2 et de soulager définitivement l'aorte abdominale 1 pour empêcher toute rupture de l'anévrisme 1f.The upper ends 2b are deformed by means of special pocket devices so that the mesh sleeves 3 press each tube 2a against the internal wall of the abdominal aorta 1. It is noted that the hooks 5 of each sleeve 3 penetrate the wall internal of the abdominal aorta to improve the anchoring of the endoprosthesis 2. Likewise, the lower ends 2c are deformed by means of special pocket devices so that the mesh sleeves 4 of each tube 2a are pressed against the internal wall of the primary iliac artery 1a, 1b or against the internal wall of the external iliac artery 1g, 1h. It then suffices to remove the devices with particular bags to allow blood circulation to pass through the stent 2 and to permanently relieve the abdominal aorta 1 to prevent any rupture of the aneurysm 1f.
On remarque, après déformation des extrémités supérieures 2b des tubes 2a et des manchons 3 que la périphérie externe de chaque tube 2a d'une part épouse parfaitement la paroi interne de l'aorte abdominale 1 , et d'autre part est en appui contre la périphérie externe de l'autre tube pour assurer une étanchéité entre lesdits tubes 2a de l'endoprothèse 2 (figure 5). Pour cela, il est prévu que le diamètre des manchons 3 soit suffisant pour permettre leur déformation simultanée pour obtenir la configuration de figure 5.It is noted, after deformation of the upper ends 2b of the tubes 2a and of the sleeves 3 that the external periphery of each tube 2a on the one hand perfectly matches the internal wall of the abdominal aorta 1, and on the other hand is pressed against the outer periphery of the other tube to ensure a seal between said tubes 2a of the stent 2 (Figure 5). For this, provision is made for the diameter of the sleeves 3 to be sufficient to allow their simultaneous deformation to obtain the configuration of FIG. 5.
On a représenté en figures 4 et 6 une variante de l'endoprothèse 2 suivant la présente invention dont l'estrémité supérieure 2b de chaque tube 2a est solidaire d'un manchon 3 ayant la même configuration que ceux décrits préalablement. On remarque que chaque manchon 3 est dans ce cas partiellemnt engagé à l'intérieur du tube 2a correspondant. En effet, cette solution est prévue lorsque l'anévrisme 1f remonte à proximité des artères rénales 1d et 1e, supprimant ainsi une partie de l'aorte abdominale 1 pour ia fixation de l'endoprothèse 2. Dans ce cas, les manchons 3 doivent venir se fixer au dessus des artère rénales 1d et 1e sans que l'extrémité supérieure 2b de chaque tube 2a vienne les obstruer.There is shown in Figures 4 and 6 a variant of the stent 2 according to the present invention, the upper end 2b of each tube 2a is secured to a sleeve 3 having the same configuration as those described above. It is noted that each sleeve 3 is in this case partially engaged inside the corresponding tube 2a. In fact, this solution is provided when the aneurysm 1f rises near the renal arteries 1d and 1e, thus eliminating part of the abdominal aorta 1 for fixing the stent 2. In this case, the sleeves 3 must come fix above the renal arteries 1d and 1e without the upper end 2b of each tube 2a obstructing them.
Ainsi, les manchons 3 sont déformés de la même manière que précédemment, mais les crochets 5 viennent se fixer dans la paroi interne de l'aorte abdominale 1 et au dessus des artères rénales 1d et 1e, tandis que les extrémités supérieures 2b de chaque tube 2a se trouvent en dessous des artères rénales 1d et 1e. La configuration des manchons 3 permet l'écoulement du flux sanguin dans les artères rénales 1d et 1e et ceci sans les obstruer.Thus, the sleeves 3 are deformed in the same manner as above, but the hooks 5 are fixed in the internal wall of the abdominal aorta 1 and above the renal arteries 1d and 1e, while the upper ends 2b of each tube 2a are located below the renal arteries 1d and 1e. The configuration of the sleeves 3 allows the flow of blood flow in the renal arteries 1d and 1e and this without obstructing them.
De même, les manchons 4 de chaque tube 2a adaptés à l'extrémité inférieure 2c peuvent n'être engagés que partiellement afin de pouvoir s'ancrer dans l'artère iliaque esterne 1g, 1 h sans empêcher le passage du flux sanguin dans l'autre artère iliaque interne 1i, 1j.Similarly, the sleeves 4 of each tube 2a adapted to the lower end 2c may be engaged only partially so as to be able to anchor in the estiac iliac artery 1g, 1h without preventing the passage of blood flow in the other internal iliac artery 1i, 1d.
Chaque fil constituant le grillage des manchons 3 et 4 présente un état de surface adapté pour assurer un ancrage suffisant soit à l'intérieur de chaque tube 2a, soit à l'intérieur de chaque artère.Each wire constituting the mesh of the sleeves 3 and 4 has a surface condition suitable for ensuring sufficient anchoring either inside each tube 2a, or inside each artery.
Il va de soi que les tubes 2a de l'endoprothèse 2 peuvent se croiser sans influencer la méthode de fixation de ladite endoprothèse.It goes without saying that the tubes 2a of the stent 2 can cross without influencing the method of fixing said stent.
Il doit d'ailleurs être entendu que la description qui précède n'a été donnée qu'a titre d'exemple et qu'elle ne limite nullement le domaine de l'invention dont on ne sortirait pas en remplaçant les détails d'exécution décrits par tous autres équivalents. It should moreover be understood that the above description has been given only by way of example and that it in no way limits the field of the invention from which one would not depart by replacing the execution details described by all other equivalents.

Claims

REVENDICATIONS
1. Endoprothèse aorto-iliaque pour le traitements des anévrismes de l'aorte abdominale, comprenant deux tubes (2a) susceptibles de sedéformer éiastiquement dans toutes les directions et dont chaque extrémité (2b, 2c) est solidaire d'un manchon grillagé (3, 4), caractérisée en ce que lesdits tubes sont à profil coniques afin que leurs extrémités supérieures (2b) soient d'un diamètre plus important que celui de leurs extrémités inférieures (2c), tandis que lesdits manchons sont munis de moyens d'accrochage (5) pour la retenue de l'endoprothèse et sont réalisés dans une matière métallique bio-compatible, déformable et à mémoire de forme.1. Aortoiliac stent for the treatment of aneurysms of the abdominal aorta, comprising two tubes (2a) capable of deforming elastically in all directions and each end of which (2b, 2c) is integral with a mesh sleeve (3, 4), characterized in that said tubes are of conical profile so that their upper ends (2b) are of a larger diameter than that of their lower ends (2c), while said sleeves are provided with hooking means ( 5) for retaining the endoprosthesis and are made of a biocompatible, deformable metallic material with shape memory.
2. Endoprothèse aorto-iliaque selon la revendication 1, caractérisée en ce que lesdites extrémités (2b) de plus grand diamètre desdits tubes à profil conique sont réunies l'une contre l'autre par déformation desdits manchons grillagés (3) de manière que la périphérie externe de chaque tube (2a), d'une part, épouse parfaitement la paroi interne de l'aorte abdominale (1) et, d'autre part, est en appui contre ta périphérie externe de l'autre tube pour assurer une parfaite étanchéité de l'endoprothèse (2).2. Aortoiliac endoprosthesis according to claim 1, characterized in that said ends (2b) of larger diameter of said conical profile tubes are joined against each other by deformation of said mesh sleeves (3) so that the outer periphery of each tube (2a), on the one hand, perfectly matches the inner wall of the abdominal aorta (1) and, on the other hand, is pressed against your outer periphery of the other tube to ensure perfect sealing of the stent (2).
3. Endoprothèse aorto-iliaque suivant la revendication 1, caractérisée en ce que les extrémités supérieures (2b) de chaque tube (2a) recouvrent en totalité les manchons correspondants (3) ne laissant passer que les crochets (5) pour la retenue de l'endoprothèse (2) dans la paroi interne de l'aorte abdominale (1).3. Aortoiliac endoprosthesis according to claim 1, characterized in that the upper ends (2b) of each tube (2a) completely cover the corresponding sleeves (3) allowing only the hooks (5) to retain the stent (2) in the inner wall of the abdominal aorta (1).
4. Endoprothèse aorto-iliaque suivant la revendication 1, caractérisée en ce que les extrémités supérieures (2b) de chaque tubes (2a) ne recouvrent que partiellement les manchons (3) de manière que les crochets (5) viennent se fixer dans la paroi interne de l'aorte abdominale (1) au dessus des artères rénales (1d et 1e) pour laisser le passage du flux sanguin.4. Aortoiliac stent according to claim 1, characterized in that the upper ends (2b) of each tube (2a) only partially cover the sleeves (3) so that the hooks (5) are fixed in the wall internal abdominal aorta (1) above the renal arteries (1d and 1e) to allow the passage of blood flow.
5. Endoprothèse aorto-iliaque suivant la revendication 1, caractérisée en ce que les extrémités inférieures (2c) de chaque tube (2a) recouvrent en totalité les manchons correspondants (4) ne laissant passer que les crochets (5) pour la retenue de l'endoprothèse (2) dans la paroi interne de l'artère iliaque primitive (1a, 1b).5. Aorto-iliac endoprosthesis according to claim 1, characterized in that the lower ends (2c) of each tube (2a) completely cover the corresponding sleeves (4) allowing only the hooks (5) to retain the stent (2) in the inner wall of the primary iliac artery (1a, 1b).
6. Endoprothèse aorto-iliaque suivant la revendication 1, caractérisée en ce que les extrémités inférieures (2c) de chaque tubes (2a) ne recouvre ent que partiellement les manchons (4) de manière que les crochets (5) viennent se fixer dans la paroi interne de l'artère iliaque externe (1g, 1h) pour laisser le passage du flux sanguin dans l'artère iliaque interne (1i, 1j).6. Aortoiliac stent according to claim 1, characterized in that the lower ends (2c) of each tube (2a) only partially cover the sleeves (4) so that the hooks (5) are fixed in the internal wall of the external iliac artery (1g, 1h) to allow the passage of blood flow in the internal iliac artery (1i, 1d).
7. Endoprothèse aorto-iliaque suivant la revendication 1, caractérisée en ce que le fil constituant le grillage des manchons (3, 4) présente un état de surface adapté pour assurer un ancrage suffisant soit à l'intérieur de chaque tube (2a), soit à l'intérieur de chaque artère. 7. Aorto-iliac endoprosthesis according to claim 1, characterized in that the wire constituting the mesh of the sleeves (3, 4) has a surface condition suitable for ensuring sufficient anchoring either inside each tube (2a), either inside each artery.
PCT/FR1997/000005 1996-01-08 1997-01-02 Aortoiliac endoprosthesis WO1997025001A1 (en)

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FR9600277A FR2743293B1 (en) 1996-01-08 1996-01-08 AORTO-ILIAC STENT

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