WO1999030638A1 - Coronary prosthesis - Google Patents

Coronary prosthesis Download PDF

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Publication number
WO1999030638A1
WO1999030638A1 PCT/FR1998/002710 FR9802710W WO9930638A1 WO 1999030638 A1 WO1999030638 A1 WO 1999030638A1 FR 9802710 W FR9802710 W FR 9802710W WO 9930638 A1 WO9930638 A1 WO 9930638A1
Authority
WO
WIPO (PCT)
Prior art keywords
membrane
coronary
molecular weight
endoprosthesis according
molecules
Prior art date
Application number
PCT/FR1998/002710
Other languages
French (fr)
Inventor
Paul Barragan
Original Assignee
Microval (S.A.R.L.)
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 Microval (S.A.R.L.) filed Critical Microval (S.A.R.L.)
Priority to AU15680/99A priority Critical patent/AU1568099A/en
Publication of WO1999030638A1 publication Critical patent/WO1999030638A1/en

Links

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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts

Definitions

  • the present invention relates to a coronary stent for vascular support.
  • FR2727854 describes a self-expanding endoprosthesis, intended for the maintenance of walls of anatomical canals.
  • the object of the present invention is to avoid this drawback by proposing a stent preventing, or at least reducing, cell proliferation.
  • the invention relates in its most general sense to a stent covered by a single-layer micro-porous membrane forming a screen.
  • This membrane is a passive membrane, that is to say without action of release of drugs or active substances.
  • This membrane is preferably unidirectional, that is to say that it allows certain molecules of a molecular weight less than the diameter of the holes in the membrane to pass in one direction only, from the vascular wall to the arterial lumen.
  • the membrane is hydrophilic.
  • the coronary endoprosthesis according to the invention is covered with a membrane allowing the passage of molecules with a molecular weight which can vary from 1000 to 60000 depending on the diameter of the pores of the membrane.
  • the membrane has a thickness of between 0.1mm and 0.2mm.
  • the membrane is a dialysis membrane.
  • the membrane is treated by ion bombardment, in order to precisely adjust the diameter of these pores.
  • the endoprosthesis is formed by an openwork metallic structure having meshes alternating with a network of wires or shoring walls.
  • This metallic structure is generally expandable using a balloon.
  • the outer surface of this metallic structure is covered by a porous membrane (dialysis) with a thickness of 0.1mm.
  • This membrane is a biocompatible membrane made up of a sieve allowing the passage of molecules whose molecular weight can vary from
  • This membrane can be formed by a dialysis membrane for hemodialysis usually having the form of flat sheets, sheathed or hollow fiber sheets of polysaccharide ether. This membrane is deposited on the expandable support structure.
  • the membrane may also be a polysulfone membrane in the form of a hollow fiber comprising, on its inner surface, a layer of dense skin having no observable pores and on its outer surface micropores having an average pore diameter of 50 to 500 mm with a fractional surface porosity of 5 to 50%.
  • a membrane capable of coating the support structure is a membrane in the form of a hollow fiber for the dialysis of blood, formed by spinning in the molten state of a block copolymer.
  • Another membrane adapted to the invention is a synthetic membrane or one based on modified cellulose.
  • These can be polyacrylonitrite type membranes, for example a copolymer of acrylonitrite, methacrylate, methylene and acrylic acid or a copolymer of acrylonitrile and a salt such as sodium methallyl sulfonate. It has a homogeneous symmetrical structure and a hydrophilic behavior. The average pore size is around 30 angstroms, the maximum opening is around 55 angstroms. It allows the diffusion of small molecules and the convective transfer of larger molecules.
  • the membrane has a high hydraulic permeability and a high permeability to solutes in the molecular weight range between 1000 and 60,000 daltons.
  • the sieving coefficient from 0 to a molecular weight of 35,000 daltons.

Abstract

The invention concerns a coronary prosthesis for vascular shoring, covered with a microporous membrane.

Description

ENDOPROTHESE CORONAIRE. CORONARY ENDOPROSTHESIS.
La présente invention concerne une endoprothèse coronaire pour l'étayage vasculaire.The present invention relates to a coronary stent for vascular support.
On connaît dans l'état de la technique des endoprothèses formées par une armature en fil ou en une feuille métallique ajourée, dont le but est d'étayer la paroi vasculaire. A titre d'exemple, le brevet françaisThere are known in the prior art endoprostheses formed by a wire frame or an openwork metal sheet, the purpose of which is to support the vascular wall. For example, the French patent
FR2727854 décrit une endoprothèse autoexpansible, destinée au maintien de parois de canaux anatomiques.FR2727854 describes a self-expanding endoprosthesis, intended for the maintenance of walls of anatomical canals.
L'introduction d'un corps étranger produit toutefois une prolifération cellulaire au niveau des mailles du stent. Cette prolifération provoque au bout de quelques mois une diminution de la lumière vasculaire préjudiciable.The introduction of a foreign body, however, produces cell proliferation at the level of the stent meshes. This proliferation causes after a few months a decrease in the harmful vascular lumen.
On a également proposé dans l'art antérieur de revêtir une endoprothèse avec une membrane. Dans le brevet américain US5639278, on a proposé une membrane destinée à faciliter la prolifération cellulaire réalisant un ancrage de la prothèse.It has also been proposed in the prior art to coat a stent with a membrane. In US patent US 5,639,278, a membrane has been proposed intended to facilitate cell proliferation providing anchoring of the prosthesis.
On a encore proposé dans le brevet américain US5578075, dans le brevet US5653760 ou US5383928 ou dans le brevet W097/42911 de munir une endoprothèse d'une membrane permettant la délivrance de molécules actives à effet thérapeutique.It has also been proposed in American patent US5578075, in patent US5653760 or US5383928 or in patent WO97 / 42911 to provide a stent with a membrane allowing the delivery of active molecules with therapeutic effect.
Le but de la présente invention est d'éviter cet inconvénient en proposant une endoprothèse évitant, ou au moins réduisant, la prolifération cellulaire. A cet effet, l'invention concerne dans son acception la plus générale une endoprothèse vasculaire recouverte par une membrane micro-poreuse monocouche formant tamis. Cette membrane est une membrane passive, c'est à dire sans action de libération de médicaments ou de substances actives. Cette membrane est de préférence unidirectionnelle, c'est-à-dire qu'elle laisse passer certaines molécules d'un poids moléculaire inférieur au diamètre des trous de la membrane dans un sens seulement, de la paroi vasculaire vers la lumière artérielle.The object of the present invention is to avoid this drawback by proposing a stent preventing, or at least reducing, cell proliferation. To this end, the invention relates in its most general sense to a stent covered by a single-layer micro-porous membrane forming a screen. This membrane is a passive membrane, that is to say without action of release of drugs or active substances. This membrane is preferably unidirectional, that is to say that it allows certain molecules of a molecular weight less than the diameter of the holes in the membrane to pass in one direction only, from the vascular wall to the arterial lumen.
Avantageusement, la membrane est hydrophile. De préférence, endoprothèse coronaire selon l'invention est recouverte d'une membrane laissant le passage des molécules d'un poids moléculaire pouvant varier de 1000 à 60000 en fonction du diamètre des pores de la membrane.Advantageously, the membrane is hydrophilic. Preferably, the coronary endoprosthesis according to the invention is covered with a membrane allowing the passage of molecules with a molecular weight which can vary from 1000 to 60000 depending on the diameter of the pores of the membrane.
De préférence, la membrane présente une épaisseur comprise entre 0,1mm et 0,2mm.Preferably, the membrane has a thickness of between 0.1mm and 0.2mm.
Selon un mode de mise en œuvre préféré, la membrane est une membrane de dialyse. Selon une variante, la membrane est traitée par bombardement ionique, afin d'ajuster avec précision le diamètre de ces pores.According to a preferred embodiment, the membrane is a dialysis membrane. According to a variant, the membrane is treated by ion bombardment, in order to precisely adjust the diameter of these pores.
L' endoprothèse est formée par une structure métallique ajourée présentant des mailles alternant avec un réseau de fils ou de parois d'étayage. Cette structure métallique est généralement dilatable à l'aide d'un ballonnet. La surface extérieure de cette structure métallique est recouverte par une membrane poreuse (dialyse) d'une épaisseur de 0,1mm.The endoprosthesis is formed by an openwork metallic structure having meshes alternating with a network of wires or shoring walls. This metallic structure is generally expandable using a balloon. The outer surface of this metallic structure is covered by a porous membrane (dialysis) with a thickness of 0.1mm.
Cette membrane est une membrane biocompatible constituée d'un tamis laissant passer les molécules dont le poids moléculaire peut varier deThis membrane is a biocompatible membrane made up of a sieve allowing the passage of molecules whose molecular weight can vary from
1.000 à 60.000 en fonction de ces pores. Cette membrane peut être formée par une membrane de dialyse pour l 'hémodialyse présentant habituellement la forme de feuilles planes, de feuilles en gaine ou de fibres creuses en éther de polysaccharide. Cette membrane est déposée sur la structure support expansible.1,000 to 60,000 depending on these pores. This membrane can be formed by a dialysis membrane for hemodialysis usually having the form of flat sheets, sheathed or hollow fiber sheets of polysaccharide ether. This membrane is deposited on the expandable support structure.
La membrane peut également être une membrane en polysulfone sous forme de fibre creuse comprenant, sur sa surface intérieure, une couche de peau dense n'ayant pas de pores observables et sur sa surface extérieure des micropores ayant un diamètre moyen des pores de 50 à 500 mm avec une porosité surfacique fractionnaire de 5 à 50 %.The membrane may also be a polysulfone membrane in the form of a hollow fiber comprising, on its inner surface, a layer of dense skin having no observable pores and on its outer surface micropores having an average pore diameter of 50 to 500 mm with a fractional surface porosity of 5 to 50%.
Un autre exemple de membrane susceptible de revêtir la structure support est une membrane sous forme de fibre creuse pour la dialyse du sang, formée par filage à l'état fondu d'un copolymère séquence.Another example of a membrane capable of coating the support structure is a membrane in the form of a hollow fiber for the dialysis of blood, formed by spinning in the molten state of a block copolymer.
Une autre membrane adaptée à l'invention est une membrane synthétique ou à base de cellulose modifiée. Il peut s'agir de membranes de type polyacrylonitrite, par exemple un copolymère d'acrylonitrite, de méthacrylate, de méthylène et d'acide acrylique ou un copolymère d'acrynonitrile et d'un sel tel que le méthallyl sulfonate de sodium. Elle présente une structure symétrique homogène et un comportement hydrophile. La taille moyenne des pores est d'environ 30 angstrôm, l'ouverture maximale d'environ 55 angstrôm. Elle permet la diffusion des molécules de petite taille et le transfert convectif des molécules plus grosses. Pour favoriser le transfert convectif , la membrane présente une perméabilité hydraulique élevée et une perméabilité élevée aux solutés dans la gamme de poids moléculaire compris entre 1000 et 60000 daltons. Le coefficient de tamisage de 0 vers un poids moléculaire de 35000 daltons. Another membrane adapted to the invention is a synthetic membrane or one based on modified cellulose. These can be polyacrylonitrite type membranes, for example a copolymer of acrylonitrite, methacrylate, methylene and acrylic acid or a copolymer of acrylonitrile and a salt such as sodium methallyl sulfonate. It has a homogeneous symmetrical structure and a hydrophilic behavior. The average pore size is around 30 angstroms, the maximum opening is around 55 angstroms. It allows the diffusion of small molecules and the convective transfer of larger molecules. To promote convective transfer, the membrane has a high hydraulic permeability and a high permeability to solutes in the molecular weight range between 1000 and 60,000 daltons. The sieving coefficient from 0 to a molecular weight of 35,000 daltons.

Claims

REVENDICATIONS
-1- Endoprothèse coronaire pour l'étayage vasculaire recouverte par une membrane micro-poreuse caractérisée en ce que la membrane microporeuse monocouche forme un tamis passif.-1- Coronary endoprosthesis for vascular support covered by a micro-porous membrane characterized in that the single-layer microporous membrane forms a passive sieve.
-2- Endoprothèse coronaire selon la revendication 1 caractérisée en ce que la membrane micro-poreuse est du type laissant le passage des molécules d'un poids moléculaire (PM) pouvant varier de 1.000 à 60.000 en fonction du diamètre de ses pores.-2- Coronary endoprosthesis according to claim 1 characterized in that the microporous membrane is of the type allowing the passage of molecules with a molecular weight (PM) which can vary from 1,000 to 60,000 depending on the diameter of its pores.
-3- Endoprothèse coronaire selon la revendication 1 caractérisée en ce que la membrane micro-poreuse est du type laissant le passage des molécules d'un poids moléculaire (PM) de l'ordre de 60.000.-3- Coronary endoprosthesis according to claim 1 characterized in that the micro-porous membrane is of the type allowing the passage of molecules with a molecular weight (PM) of the order of 60,000.
-4- endoprothèse coronaire selon l'une au moins des revendications précédentes caractérisée en ce que la membrane présente une épaisseur compris entre 0,1 mm et 0,2mm.-4- coronary stent according to at least one of the preceding claims, characterized in that the membrane has a thickness of between 0.1 mm and 0.2 mm.
-5- Endoprothèse coronaire selon l'une au moins des revendications précédentes caractérisée en ce que la membrane est une membrane de dialyse.-5- Coronary endoprosthesis according to at least one of the preceding claims, characterized in that the membrane is a dialysis membrane.
-6- Endoprothèse coronaire selon l'une au moins des revendications précédentes caractérisée en ce que la membrane est traitée par bombardement ionique. -7- Endoprothèse coronaire selon l'une au moins des revendications précédentes caractérisée en ce que la membrane présente un coefficient de tamisage de 0 pour un poids moléculaire d'environ 35000 daltons. -6- Coronary endoprosthesis according to at least one of the preceding claims, characterized in that the membrane is treated by ion bombardment. -7- Coronary endoprosthesis according to at least one of the preceding claims, characterized in that the membrane has a screening coefficient of 0 for a molecular weight of approximately 35,000 daltons.
PCT/FR1998/002710 1997-12-12 1998-12-11 Coronary prosthesis WO1999030638A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU15680/99A AU1568099A (en) 1997-12-12 1998-12-11 Coronary prosthesis

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR97/15801 1997-12-12
FR9715801A FR2772258A1 (en) 1997-12-12 1997-12-12 CORONARY ENDOPROSTHESIS

Publications (1)

Publication Number Publication Date
WO1999030638A1 true WO1999030638A1 (en) 1999-06-24

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Application Number Title Priority Date Filing Date
PCT/FR1998/002710 WO1999030638A1 (en) 1997-12-12 1998-12-11 Coronary prosthesis

Country Status (3)

Country Link
AU (1) AU1568099A (en)
FR (1) FR2772258A1 (en)
WO (1) WO1999030638A1 (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6428569B1 (en) 1999-11-09 2002-08-06 Scimed Life Systems Inc. Micro structure stent configurations
US7060089B2 (en) 2002-01-23 2006-06-13 Boston Scientific Scimed, Inc. Multi-layer stent
US7226475B2 (en) 1999-11-09 2007-06-05 Boston Scientific Scimed, Inc. Stent with variable properties

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4374669A (en) * 1975-05-09 1983-02-22 Mac Gregor David C Cardiovascular prosthetic devices and implants with porous systems
US5069945A (en) * 1986-10-20 1991-12-03 Memtec America Corporation Ultrapous thin-film membranes
US5383928A (en) * 1992-06-10 1995-01-24 Emory University Stent sheath for local drug delivery
US5578075A (en) * 1992-11-04 1996-11-26 Michael Peck Dayton Minimally invasive bioactivated endoprosthesis for vessel repair
US5639278A (en) * 1993-10-21 1997-06-17 Corvita Corporation Expandable supportive bifurcated endoluminal grafts
US5653760A (en) * 1993-08-30 1997-08-05 Saffran; Bruce N. Method and apparatus for managing macromolecular distribution
WO1997042911A1 (en) * 1996-05-15 1997-11-20 Medtronic, Inc. Intraluminal stent
EP0815806A2 (en) * 1996-06-27 1998-01-07 Cordis Corporation Controlled porosity endovascular implant

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4374669A (en) * 1975-05-09 1983-02-22 Mac Gregor David C Cardiovascular prosthetic devices and implants with porous systems
US5069945A (en) * 1986-10-20 1991-12-03 Memtec America Corporation Ultrapous thin-film membranes
US5383928A (en) * 1992-06-10 1995-01-24 Emory University Stent sheath for local drug delivery
US5578075A (en) * 1992-11-04 1996-11-26 Michael Peck Dayton Minimally invasive bioactivated endoprosthesis for vessel repair
US5578075B1 (en) * 1992-11-04 2000-02-08 Daynke Res Inc Minimally invasive bioactivated endoprosthesis for vessel repair
US5653760A (en) * 1993-08-30 1997-08-05 Saffran; Bruce N. Method and apparatus for managing macromolecular distribution
US5639278A (en) * 1993-10-21 1997-06-17 Corvita Corporation Expandable supportive bifurcated endoluminal grafts
WO1997042911A1 (en) * 1996-05-15 1997-11-20 Medtronic, Inc. Intraluminal stent
EP0815806A2 (en) * 1996-06-27 1998-01-07 Cordis Corporation Controlled porosity endovascular implant

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
"ADVERTISEMENT", NTIS TECH NOTES, 1 January 1991 (1991-01-01), pages 86, XP000383525 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6428569B1 (en) 1999-11-09 2002-08-06 Scimed Life Systems Inc. Micro structure stent configurations
US7226475B2 (en) 1999-11-09 2007-06-05 Boston Scientific Scimed, Inc. Stent with variable properties
US7879082B2 (en) 1999-11-09 2011-02-01 Boston Scientific Scimed, Inc. Micro structure stent configurations
US7060089B2 (en) 2002-01-23 2006-06-13 Boston Scientific Scimed, Inc. Multi-layer stent

Also Published As

Publication number Publication date
AU1568099A (en) 1999-07-05
FR2772258A1 (en) 1999-06-18

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