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WO2011051812A1 - Endoprosthesis comprising at least one collateral branch attached to a pre-established window - Google Patents

Endoprosthesis comprising at least one collateral branch attached to a pre-established window 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
Authority
WO
WIPO (PCT)
Prior art keywords
endoprosthesis
collar
cylindrical structure
stent
shape
Prior art date
Application number
PCT/IB2010/003078
Other languages
French (fr)
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/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
    • 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.

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  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The present invention relates to an endoprosthesis (1) comprising at least one collateral branch attached to at least one pre- established window (6). Endoprosthesis characterized in that the collateral branch or branches are attached in the form of an extensible framework or stent (5). The invention is applicable more particularly in the field of medicine, in particular of reparative surgery, and especially of endovascular surgery.

Description

Endoprosthesis comprising at least one collateral branch attached
to a pre-established window
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. By contrast, 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.
It has been proposed to perform such revascularization by using hybrid techniques starting from the ascending aorta, which combines open surgery for bypassing the supra-aortic trunks prior to placement of a conventional covered endoprosthesis covering the mouths of the supra- aortic trunks, or by using branched endoprostheses. To this end, various prototypes have been proposed which are relatively complicated to use, on account of the fact that they necessitate either anterograde catheterization of the trunks starting from the thoracic endoprosthesis, or retrograde catheterization in order to rejoin the thoracic endoprosthesis. 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).
In order to implement these latter techniques, 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.
For an intervention in the area of the thoracic aorta, a procedure using an endoprosthesis is also known 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.
To this end, 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.
The invention will be better understood from the following description of preferred embodiments, which are given as non-limiting examples and are explained with reference to the attached schematic drawings, in which:
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, and
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.
According to the invention, the attached collateral branch, or preferably each attached collateral branch, is in the form of an extensible framework or stent 5.
In the embodiment shown in Figure 1 of the attached drawings, the endoprosthesis 1 is a thoracic endoprosthesis and is used with three collateral branches formed by the extensible frameworks or stents 5. However, the invention concerns endoprostheses of all types comprising at least one collateral branch.
The use of 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.
According to one feature of the invention, and as is shown in Figures 2 to 7 of the attached drawings, said or 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". These two elements, namely the cylindrical structure 5' and the collar 5", are joined together by a leaktight suture, as is shown in Figures 2a to 6b of the attached drawings.
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).
According to another feature of the invention, the elements made of shape-memory material and forming the tubular element 5 Γ 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.
According to another feature of the invention, and as is shown in Figure 7b of the attached drawings, 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.
It is thus possible to obtain a supplementary angular freedom of the stent 5, making it easier to fit in place. Moreover, 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. For this purpose, 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.
According to an alternative embodiment (not shown in the attached drawings) of the invention, 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. The result of this is that a diversion of the flow of blood is obtained to the collateral branch, after application of the collar in the endoprosthesis, on the window and before the final deployment of the stent and the fixing thereof in said collateral branch. 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.
Such optimization of the placement of the endoprosthesis 1 is linked to the considerable resistance to traction of the collar 5". In addition, the distal part of the stent 5, seen in the direction of the arterial flow, or proximal part, in the sense of the direction of release, will be able to be easily fixed, on account of the fact that it is situated in the cervical surgical access zone, which is easier to access.
Finally, in the case of simultaneous placement of several collateral branches on a thoracic endoprosthesis 1 , the use of an extensible framework or stent 5, of which the covering of the tubular element 51' of the cylindrical structure 5' by the textile membrane 52' has a circumferential interruption near the free end of said cylindrical structure 5', will make it possible to ensure perfusion of the catheterized vessel throughout the duration of the positioning procedure. The reason is that, by using such a stent with an interruption of the covering, the arterial blood can pass from the endoprosthesis 1 into the extensible framework or stent 5, then through the uncovered or uncoated part of the stent 5 around the deployment device and the catheter, such that the artery continues to remain irrigated throughout the placement procedure. At the end of the positioning procedure, the extensible framework or stent 5 is definitively deployed and fixed. A complementary sealing of the distal part, as seen in the direction of flow, can be obtained by placing a standard covered endoprosthesis on this end.
The existence of a degree of freedom of the angle between the cylindrical structure 5' of the stent 5 and the collar 5" of the latter makes it possible to compensate for slight differences of orientation between the window 6 of the endoprosthesis 1 and the mouth of the supra-aortic trunk in question and to reduce the risks of disconnection presented by a connection formed under stress in a zone of high mobility such as the aortic arch and/or an endoprosthesis in the aortic arch. This degree of freedom then acts as a mechanical shock absorber during the systolodiastolic variations.
By virtue of the 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. Of course, 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.
After the optimal positioning has been obtained, 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.
By virtue of the invention, 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.
Of course, the invention is not limited to the embodiments that have been described and that are shown in the attached drawings. Modifications remain possible, especially from the point of view of the make-up of the various elements or substitution of technical equivalents, without thereby departing from the scope of protection of the invention.

Claims

1. Endoprosthesis (1) comprising at least one collateral branch attached to at least one pre-established window (6), characterized in that at least one collateral branch is attached in the form of an extensible framework or stent (5).
2. Endoprosthesis according to Claim 1, characterized in that at least one stent (5), preferably each extensible framework or stent (5), forming a collateral branch of the endoprosthesis (1) is 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'), this cylindrical structure (5') and the collar (5") being able to be folded up on themselves along the longitudinal axis of the cylindrical structure (5') and being extensible perpendicular to this axis.
3. Endoprosthesis according to Claim 2, characterized in that said cylindrical structure (51) is formed by a tubular element (5 ) made of a shape-memory material and surrounded by a textile membrane (52'), and said collar (5") is formed as a disc (51"), also made of a shape-memory material and provided with a central opening and surrounded by a textile membrane (52").
4. Endoprosthesis according to Claim 3, characterized in that the cylindrical structure (5') and the collar (5") are joined together by a leaktight suture.
5. Endoprosthesis according to either of Claims 3 and 4, characterized in that 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', 52") by stitches.
6. Endoprosthesis according to either of Claims 3 and 4, characterized in that the textile membranes (52', 52") 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.
7. Endoprosthesis according to either of Claims 3 and 4, characterized in that the mechanical elements made of shape-memory material are advantageously formed in 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').
8. Endoprosthesis according to any one of Claims 3 to 7, characterized in that the covering of the tubular element (5 ) of the cylindrical structure (5') of the extensible framework or stent (5) by the textile membrane (52') can advantageously have a circumferential interruption near the free end of said cylindrical structure (5').
9. Endoprosthesis according to Claim 1, characterized in that each extensible framework or stent (5) forming a collateral branch of the endoprosthesis (1) 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.
10. Endoprosthesis according to Claim 1, characterized in that each extensible framework or stent (5) forming a collateral branch of the endoprosthesis (1) 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 to the endoprosthesis (1), engages with a circumferential ring (1") provided in the window (6) of this endoprosthesis (1).
11. Endoprosthesis according to any one of Claims 3 and 5 to 9, characterized in that the shape-memory material is 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.
12. Endoprosthesis according to any one of Claims 1 to 11, characterized in that the extensible framework or stent (5) is fixed in the endoprosthesis (1) by way 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).
PCT/IB2010/003078 2009-10-28 2010-10-28 Endoprosthesis comprising at least one collateral branch attached to a pre-established window WO2011051812A1 (en)

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WO2014180161A1 (en) * 2013-05-08 2014-11-13 中国人民解放军第二军医大学 Branched and open-window type thoracic aorta endovascular exclusion transplant
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CN106214287A (en) * 2016-08-24 2016-12-14 杨威 Dissection of aorta operation overlay film frame, conveyer device and using method

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Publication number Priority date Publication date Assignee Title
FR2995206A1 (en) * 2012-09-11 2014-03-14 Univ Strasbourg TREATMENT KIT, TREATMENT DEVICE AND METHOD FOR MANUFACTURING THE SAME
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CN104905892A (en) * 2015-06-16 2015-09-16 中国人民解放军第四军医大学 Integrated multiple-branch interventional aorta arch covered stent
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CN106214287A (en) * 2016-08-24 2016-12-14 杨威 Dissection of aorta operation overlay film frame, conveyer device and using method

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