WO2011051812A1 - Endoprothèse comprenant au moins une branche collatérale fixée à une fenêtre préétablie - Google Patents

Endoprothèse comprenant au moins une branche collatérale fixée à une fenêtre préétablie Download PDF

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Publication number
WO2011051812A1
WO2011051812A1 PCT/IB2010/003078 IB2010003078W WO2011051812A1 WO 2011051812 A1 WO2011051812 A1 WO 2011051812A1 IB 2010003078 W IB2010003078 W IB 2010003078W WO 2011051812 A1 WO2011051812 A1 WO 2011051812A1
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WO
WIPO (PCT)
Prior art keywords
endoprosthesis
collar
cylindrical structure
stent
shape
Prior art date
Application number
PCT/IB2010/003078
Other languages
English (en)
Inventor
Nabil Chakfe
Bernard Durand
Original Assignee
UNIVERSITE DE STRASBOURG (Etablissement Public National à Caractère Scientifique, Culturel et Professionnel)
UNIVERSITE DE HAUTE ALSACE (Etablissement Public à Caractère Scientifique, Culturel et Professionnel)
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 UNIVERSITE DE STRASBOURG (Etablissement Public National à Caractère Scientifique, Culturel et Professionnel), UNIVERSITE DE HAUTE ALSACE (Etablissement Public à Caractère Scientifique, Culturel et Professionnel) filed Critical UNIVERSITE DE STRASBOURG (Etablissement Public National à Caractère Scientifique, Culturel et Professionnel)
Publication of WO2011051812A1 publication Critical patent/WO2011051812A1/fr

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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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents 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
    • 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
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • 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
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/821—Ostial stents

Definitions

  • Endoprosthesis comprising at least one collateral branch attached
  • the present invention concerns the field of medicine, in particular of reparative vascular surgery, and especially of endovascular surgery, more particularly the prostheses used for endovascular treatment of atheromatous lesions of the aortic arch, and it relates to an endoprosthesis comprising at least one collateral branch attached to a pre-established window.
  • Aneurysms are one of the main degenerative athero-sclerotic diseases of the aorta. This disease mainly affects the infrarenal abdominal aorta and, secondarily, the thoracic and thoraco-abdominal aorta.
  • Aneurysms of the thoracic aorta are estimated at 5.9/100,000 persons per annum. Their incidence is constantly increasing on account of an ageing population, improved medical care, and the precision of the imaging techniques used to diagnose acute thoracic syndromes other than aneurysms.
  • These disorders of the thoracic aorta which are grouped under the term acute thoracic syndromes, include aneurysms, dissections, intramural haematomas and penetrating ulcers, and can be related to different degrees with the aortic arch.
  • the mortality rate following open surgery is presently between 5% and 20% for aneurysms and may be higher than 30% for dissections. Moreover, this open surgery may be accompanied by an additional complication, namely a risk of paraplegia of between 5% and 20%. Consequently, the demand for a minimally invasive technique is increasing constantly, both on the part of the medical profession and of patients.
  • the techniques of endovascular treatment of aneurysms of the thoracic aorta permit better results for the patient, both in terms of mortality and morbidity and also of the length of stay in the recovery unit and in hospital. These techniques permit the best results in the treatment of lesions of the descending thoracic aorta, which is rectilinear.
  • the treatment of lesions of the aortic arch poses, on the one hand, the problem of the high risk of migration, on account of the angulation of the arch, and, on the other hand, the problem involving the obligatory covering of the supra-aortic arterial trunks, making revascularization imperative.
  • This latter approach requires forming a hole in the thoracic endoprosthesis using mechanical or thermal devices with no possibility of control, then catheterizing the resulting hole and inserting therein, with stress, an extensible framework or stent that can be expanded by balloon.
  • This strategy causes damage to the textile structure, which is most often a woven structure and of which the long-term impact is not known (risk of shifting of the junction and of gradual opening and tearing of the sealing membrane).
  • a stent revascularizing the collateral branch is introduced in the area of the windows or holes formed in the endoprosthesis and is then dilated in order to ensure leaktightness in the distal direction.
  • the endoluminal part of this stent is dilated by a semi- compliant balloon in order to obtain an incomplete rivet effect by widening this part and applying it against the endoprosthesis.
  • the prosthesis branches permit catheterization of the collateral arterial branches and the establishment of a leaktight connection by a covered stent expandable by balloon.
  • a procedure using an endoprosthesis which involves placing such an endoprosthesis in the ascending aorta via the brachiocephalic arterial trunk, which can be re-catheterized from the descending aorta, but this necessitates a surgical vascular bypass of the left internal carotid artery and of the left subclavian artery.
  • This procedure has not yet been developed very far on account of the complexity of its implementation, and it is presently practiced only to a very limited extent.
  • the object of the present invention is to overcome the disadvantages of the treatment procedures and of the endoprostheses used hitherto by proposing a thoracic endoprosthesis that comprises at least one attached collateral branch, that can be used quickly and reliably and that ensures optimal sealing of the junction.
  • the endoprosthesis comprising at least one collateral branch attached to a pre-established window, is characterized in that the collateral branch is attached in the form of an extensible framework or stent.
  • Figure 1 is a sectional view showing an endoprosthesis according to the invention in the position of use
  • Figures 2a and 2b to Figures 6a and 6b show different embodiments of the extensible framework or stent
  • Figures 7a and 7b are perspective views of an alternative embodiment of the covering of the extensible framework or stent and of a single mechanical element
  • Figures 8 and 9 are partial sectional views showing two alternative ways of fixing the extensible framework or stent to the endoprosthesis.
  • Figure 1 of the attached drawings shows, by way of example, the arrangement of a thoracic endoprosthesis 1 in an aortic arch 2 in the area of an aneurysm 3 of the latter.
  • This thoracic endoprosthesis 1 is connected to supra-aortic arterial trunks 4 by way of at least one collateral branch attached to at least one pre-established window 6.
  • the attached collateral branch or preferably each attached collateral branch, is in the form of an extensible framework or stent 5.
  • the endoprosthesis 1 is a thoracic endoprosthesis and is used with three collateral branches formed by the extensible frameworks or stents 5.
  • the invention concerns endoprostheses of all types comprising at least one collateral branch.
  • this thoracic endoprosthesis entails placing the thoracic endoprosthesis 1, provided with three pre-established windows 6, in the aortic arch 2, then using deployment devices (not shown) to place extensible frameworks or stents 5 in the area of each pre-established window 6, with possible fixing to the arterial wall, each extensible framework or stent 5 forming an attached collateral branch finally being released from the corresponding deployment device.
  • At least one extensible framework or stent 5, preferably each extensible framework or stent 5, forming a collateral branch of the endoprosthesis 1 is advantageously formed in a T-shape by a cylindrical structure 5' and by a collar 5" arranged perpendicular to one end of the cylindrical structure 5' ( Figures 2 to 7), this cylindrical structure 5' and the collar 5" being able to be folded on themselves along the longitudinal axis of the cylindrical structure 5' and being extensible perpendicular to this axis.
  • each cylindrical structure 5' is formed by a tubular element 5 made of a shape-memory material and surrounded by a textile membrane 52', and each collar 5" is formed as a disc 1", also made of a shape-memory material and provided with a central opening and surrounded by a textile membrane 52".
  • Such a suture can be of the type with a "bourdon" stitch, a suture with contiguous threads ( Figures 2a and 2b), or joined by a flat suture, on the one hand, after shaping of the disc 51" of the collar 5" and suturing inside the textile membrane 52' of the cylindrical structure 5' ( Figures 3 a and 3b) or, on the other hand, by suturing outside the textile membrane 52' of the cylindrical structure 5' ( Figures 4a and 4b).
  • This suture can also be made after placing the textile membrane 52" of the collar 5" on the cylindrical structure 5' from the outside ( Figures 5a and 5b) or after placing the textile membrane 52" of the collar 5" on the cylindrical structure 5' from the inside ( Figures 5a and 5b), the cylindrical structure 5' then passing through the central opening of the collar 5" ( Figures 6a and 6b).
  • the elements made of shape-memory material and forming the tubular element 5 ⁇ of the cylindrical structure 5' and the disc 51" of the collar 5", respectively, are joined to the corresponding textile membranes 52' and 52" by stitches. These stitches are sufficiently spaced apart to allow the elements made of shape-memory material to move freely and thus deploy without difficulty upon withdrawal of the sheath covering the extensible framework or stent 5.
  • Figure 7a of the attached drawings shows an alternative embodiment of the invention in which the textile membranes forming the cylindrical structure 5' and the collar 5" are made as a single shaped membrane, of which the part corresponding to the collar 5" has a plurality of symmetrical or asymmetrical branches, the whole assembly being mounted on the corresponding elements made of shape-memory material, the connection between the two mechanical elements formed by the elements made of shape-memory material being provided by the single textile membrane.
  • the (mechanical) elements made of shape-memory material can advantageously be produced as a single piece comprising a cylindrical part or structure 5' that is continued at one end by symmetrical or asymmetrical branches which, in the position of use, extend in the shape of a star or toothed collar 5" perpendicular to the longitudinal axis of the cylindrical structure 5'.
  • Such an embodiment as a single piece is particularly advantageous when used with a single shaped membrane.
  • the symmetrical or asymmetrical branches can easily be folded up in a deployment device and, for a prosthesis with a diameter of 30 mm, the size taken up by them in the folded position will only be 22 mm, whereas, after release, they will be able to be effective over a half circumference of 45 mm. Moreover, such an embodiment makes it possible to use a radiated structure.
  • Figure 8 of the attached drawings shows, in a partial sectional view, and on an enlarged scale, an alternative way of fixing the extensible framework or stent 5 to the endoprosthesis 1 , wherein said (each) extensible framework or stent 5 is formed by a cylindrical structure 5' mounted on a collar 5" made of shape-memory material which, for fixing to the endoprosthesis 1, engages in a clipping action with a flange of the latter.
  • Figure 9 of the attached drawings shows another alternative way of fixing the extensible framework or stent 5 to the endoprosthesis 1, wherein the (or each) extensible framework or stent 5 is formed by a cylindrical structure 5' connected to a collar 5" in the form of an elastic ring with outer circumferential groove which, for fixing on the endoprosthesis 1, engages with a circumferential ring 1" provided in the window 6 of this endoprosthesis 1.
  • the elastic ring with outer circumferential groove forming the collar 5" is advantageously formed by two parallel circular windings 7 made of shape-memory material and mounted in the corresponding end of the cylindrical structure 5' and fixed by sutures, and the circumferential ring 1" in the window 6 of the endoprosthesis 1 is a shape-memory ring fixed by suturing to the perimeter of the window 6.
  • the shape-memory material used to obtain the deployment of the stent 5 is preferably of the type known under the name Nitinol.
  • the extensible framework or stent 5 is placed in a pre- established window 6 by way of a catheter, and the collar 5" is then freed so as to be brought into contact with the corresponding edge of the endoprosthesis 1, around said window 6.
  • the covering of the cylindrical structure of the extensible framework or stent by the textile membrane can advantageously have a circumferential interruption near the free end of said cylindrical structure.
  • This interruption can, for example, be uncovered by a supplementary traction on the deployment device corresponding to the freeing of the uncovered zone.
  • the placement of the endoprosthesis 1 in the aortic arch will then be able to be optimized by pulling on the stent 5, after which the cylindrical body 5' of the stent 5 will be able to be freed in the corresponding supra-aortic arterial trunk 4 and fixed to the arterial wall, following its release by the deployment system.
  • This fixing has the effect of reducing the risk of migration.
  • tubular structure joined to the radiated collar 5" of the stent 5 formed by a combination of a covering membrane, which can be made of polyethylene or of polytetrafluoroethylene or of any other material, and by elements made of a shape-memory material, it is possible to perform an implantation in the direction towards the main endoprosthesis 1 , by insertion by means of a catheter through the collateral vessel and the corresponding window 6, in order to form a branch. Of course, it would also be possible to form an orifice for passage during this implantation procedure.
  • the shape-memory material is advantageously braided in such a way as to permit very rapid opening both of the collar 5" and also of the cylindrical structure 5' of the stent 5, while providing substantial resistance to traction, that is to say corresponding to the force necessary for their folding.
  • the collar 5" can be made using all other known methods.
  • the extensible framework or stent 5 is fixed in the endoprosthesis 1 by placement of an internal secondary stent, which sandwiches the collar 5" against the inner face of the endoprosthesis 1 around the edge of the window 6. This fixing can also be obtained by an extension of the collar 5" in the area of the endoprosthesis 1 itself, or by way of an independent device fixed on the entire stent device 5.
  • the stent 5 is placed in a launcher which, in an initial stage, allows only the collar 5" to be released. The resistance to traction of this collar 5" then makes it possible to optimally position the endoprosthesis 1.
  • the launcher prevents the release of the tubular stent 5 during this traction, by provision of a corresponding locking device of a known type.
  • the locking device is disengaged and the stent 5, namely the cylindrical or tubular structure 5', is secondarily deployed and released from the launcher.
  • the dimensions of the stents 5 employed in relation to the endoprosthesis 1 are of course adapted to the desired dimensions, as a function of the dimensions of the supra-aortic trunks that are to be joined.
  • an endoprosthesis 1 can be produced which can be implanted easily and quickly and which avoids most of the disadvantages of the current procedures for treating atheromatous lesions of the aortic arch.

Abstract

La présente invention concerne une endoprothèse (1) comprenant au moins une branche collatérale fixée à au moins une fenêtre préétablie (6). Cette endoprothèse est caractérisée en ce que la ou les branches collatérales sont fixées sous la forme d'une structure ou d'un stent (5) extensible. L'invention s'applique plus particulièrement au domaine de la médecine, en particulier de la chirurgie réparatrice, et notamment de la chirurgie endovasculaire.
PCT/IB2010/003078 2009-10-28 2010-10-28 Endoprothèse comprenant au moins une branche collatérale fixée à une fenêtre préétablie WO2011051812A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US25568109P 2009-10-28 2009-10-28
US61/255,681 2009-10-28

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WO2011051812A1 true WO2011051812A1 (fr) 2011-05-05

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2995206A1 (fr) * 2012-09-11 2014-03-14 Univ Strasbourg Necessaire de traitement, dispositif de traitement et procede de fabrication associe
WO2014180161A1 (fr) * 2013-05-08 2014-11-13 中国人民解放军第二军医大学 Greffe d'exclusion endovasculaire d'aorte thoracique de type branché et à fenêtre ouverte
CN104905892A (zh) * 2015-06-16 2015-09-16 中国人民解放军第四军医大学 一体化多分支型介入主动脉弓覆膜支架
CN106214287A (zh) * 2016-08-24 2016-12-14 杨威 主动脉夹层手术用覆膜支架、输送装置以及使用方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060155359A1 (en) * 2005-01-13 2006-07-13 Medtronic Vascular, Inc. Branch vessel graft design and deployment method
WO2007028112A2 (fr) * 2005-09-02 2007-03-08 Medtronic Vascular, Inc. Procédés et appareil de traitement d’anévrismes adjacents a des artères à branches
US20070088425A1 (en) * 2005-10-13 2007-04-19 Cook Incorporated Endoluminal prosthesis

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060155359A1 (en) * 2005-01-13 2006-07-13 Medtronic Vascular, Inc. Branch vessel graft design and deployment method
WO2007028112A2 (fr) * 2005-09-02 2007-03-08 Medtronic Vascular, Inc. Procédés et appareil de traitement d’anévrismes adjacents a des artères à branches
US20070088425A1 (en) * 2005-10-13 2007-04-19 Cook Incorporated Endoluminal prosthesis

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2995206A1 (fr) * 2012-09-11 2014-03-14 Univ Strasbourg Necessaire de traitement, dispositif de traitement et procede de fabrication associe
WO2014041028A1 (fr) 2012-09-11 2014-03-20 Universite De Strasbourg Nécessaire de traitement, dispositif de traitement et procédé de fabrication associé
US10004616B2 (en) 2012-09-11 2018-06-26 Universite De Strasbourg Treatment kit, treatment device, and associated method of production
WO2014180161A1 (fr) * 2013-05-08 2014-11-13 中国人民解放军第二军医大学 Greffe d'exclusion endovasculaire d'aorte thoracique de type branché et à fenêtre ouverte
CN104905892A (zh) * 2015-06-16 2015-09-16 中国人民解放军第四军医大学 一体化多分支型介入主动脉弓覆膜支架
CN104905892B (zh) * 2015-06-16 2017-06-13 中国人民解放军第四军医大学 一体化多分支型介入主动脉弓覆膜支架
CN106214287A (zh) * 2016-08-24 2016-12-14 杨威 主动脉夹层手术用覆膜支架、输送装置以及使用方法

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