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EP2506797A1 - Procédé pour implanter une endoprothèse et créer une fenestration dans ladite endoprothèse - Google Patents

Procédé pour implanter une endoprothèse et créer une fenestration dans ladite endoprothèse

Info

Publication number
EP2506797A1
EP2506797A1 EP10832754A EP10832754A EP2506797A1 EP 2506797 A1 EP2506797 A1 EP 2506797A1 EP 10832754 A EP10832754 A EP 10832754A EP 10832754 A EP10832754 A EP 10832754A EP 2506797 A1 EP2506797 A1 EP 2506797A1
Authority
EP
European Patent Office
Prior art keywords
side branch
branch vessel
vessel
stent
fenestration
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP10832754A
Other languages
German (de)
English (en)
Other versions
EP2506797A4 (fr
Inventor
Gil Naor
Haim Ackerman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biflow Medical Ltd
Original Assignee
Biflow Medical Ltd
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 Biflow Medical Ltd filed Critical Biflow Medical Ltd
Publication of EP2506797A1 publication Critical patent/EP2506797A1/fr
Publication of EP2506797A4 publication Critical patent/EP2506797A4/fr
Withdrawn legal-status Critical Current

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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/94—Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • 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
    • A61F2/848—Devices 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
    • 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
    • A61F2/90—Stents 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
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/821—Ostial stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/848—Devices 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
    • A61F2002/8486—Devices 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/005—Rosette-shaped, e.g. star-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical

Definitions

  • This invention is directed to a method for creating a fenestration in a stent graft at the point where the main vessel in which the stent graft is placed branches into a side branch vessel.
  • An aneurism is a localized, blood-filled balloon-like bulge of a blood vessel, caused by the weakening of the vessel wall.
  • aneurism is an aortic aneurism, which occurs in the main artery carrying blood from the left ventricle of the heart to the body.
  • Aneurisms may be hereditary or caused by disease, either of which can lead to the weakening of the blood vessel wall.
  • the weakened section of the vessel may be replaced by a bypass graft that is sutured at the vascular stumps.
  • the graft tube ends which are made rigid and expandable by a nitinol wireframe, can be inserted into the vascular stumps and permanently fixed there by external ligature or an expandable ring.
  • Less invasive endovascular techniques allow covered metallic stent grafts to be inserted through the arteries of the leg and deployed across the aneurysm.
  • stent grafts cannot be used, and certain patients are referred to invasive surgery.
  • surgery is a relatively high risk procedure, and further, not all patients may be operated on, thus leaving a large number of patients with untreated, life threatening, aneurisms.
  • One exemplary such method of treating such aneurisms is the preparation of a tailored stent graft, prepared according to the specific anatomy of the patient being treated.
  • a tailored stent graft is prepared so that it includes openings at the branches, so as to allow blood to naturally flow from the main vessel into the side branch vessels.
  • Such stent grafts are disclosed, e.g., in U.S. Patent Application Publication No. 2005/0171598.
  • the preparation of such stent grafts is expensive and is time consuming, since each needs to be prepared specifically according to the anatomy of each treated patient.
  • the placement of such a tailored stent graft is relatively complicated, and therefore is a relatively long and high- risk procedure. Furthermore, such a procedure requires high expertise and is performed by only a very limited number of physicians.
  • US '316 Another method for treating such aneurisms is published in U.S. Patent Application Publication No. 2009/0240316 (“US '316”), although it is not known to be used in the art.
  • US '316 a bloused stent-graft is deployed into a main vessel such that the bloused section of the bloused stent-graft covers the opening of a branch vessel emanating from the main vessel.
  • the bloused section includes loose graft cloth, and a pressure differential between the main vessel and the branch vessel causes the bloused section to be forced into an ostium of the branch vessel, thereby creating a pocket aligned with the branch vessel.
  • a distal tip of a puncture device is located in the pocket and thus aligned with the branch vessel.
  • An outward force is applied to the puncture device to cause the distal tip of the puncture device to puncture the bloused section, thus creating a collateral opening, or fenestration, in the bloused section precisely aligned with the branch vessel.
  • the physician placing the stent graft monitors the placement thereof by following the blood flow. Therefore, once the bloused stent graft is placed, it would be impossible for the physician to see where the branching of the vessel is, since the blood flow has stopped. Therefore, it would be impossible, if not very difficult, to implement such a method as disclosed in US '316.
  • U.S. Patent Application Publication No. 2005/0131517 discloses a stent graft with a relatively flexible or variable fenestration, wherein the fenestration is placed at the branching vessel, and a branch vessel stent is placed in the branch vessel.
  • a flexible fenestration would be able to fit the anatomy of any given patient.
  • similar difficulties are encountered when using stenting procedures for treating any endovascular conditions involving branching of the treated blood vessel.
  • Such endovascular conditions include atherosclerotic vessel stenosis, iatrogenic stricture of a vessel, external pressure causing vessel lumen narrowing, aneurismal dilatation, bleeding vessel, and any other condition that requires stenting of a bifurcated segment either by a dilating stent or a stent graft.
  • the term "close proximity of the branching of the main vessel” is understood to mean any medical condition requiring stenting of a bifurcated segment, such as an aneurism atherosclerotic vessel stenosis, iatrogenic stricture of a vessel, external pressure causing vessel lumen narrowing, aneurismal dilatation, bleeding vessel, that is close enough to the branching of the main vessel, so that it cannot be treated by conventional methods, e.g., using a stent graft, without blocking the blood flow to the side branch vessel.
  • the medical condition requiring stenting of a bifurcated segment is considered to be too close to the branching of the main vessel when the distance between the two is approximately 13 mm or less.
  • the invention provides a method for forming a fenestration through a stent graft at a location where a main vessel in which the stent graft is placed branches into a side branch vessel, wherein the method includes:
  • the invention further provides a method for treating a medical condition in a main vessel that is in close proximity of the branching of the main vessel to a side branch vessel, including the following steps:
  • the stent graft is punctured by the side branch vessel stent from the outer side of the stent graft;
  • a puncture point is marked in the stent graft by the side branch vessel stent and additional means are used to aid in puncturing the stent graft at the pucture point.
  • the invention additionally provides the use of a side branch vessel stent to treat a medical condition in a main vessel that is in close proximity of the branching of the main vessel to a side branch vessel, comprising
  • the stent graft is punctured by the side branch vessel stent from the outer side of the stent graft;
  • a puncture point is marked in the stent graft by the side branch vessel stent and additional means are used to aid in puncturing the stent graft at the pucture point.
  • Fig. 1 shows an example of a blood vessel with an aneurism in the proximity of branch vessels
  • FIG. 2 shows a side branch vessel fenestration creation device according to some embodiments of the invention, in a closed configuration
  • FIG. 3 shows the side branch vessel fenestration creation device, according to some embodiments of the invention, in a opened configuration
  • FIG. 4 shows the placement of side branch vessel fenestration creation device in branch vessel, according to some embodiments of the invention, in the closed configuration so that the side branch vessel fenestration creation device protrudes into the main vessel lumen;
  • FIG. 5 shows the deployment of the stent graft in the main vessel, wherein a fenestration of the stent graft has been created by the side branch vessel fenestration creation device at the side branch vessel opening;
  • Fig. 6 shows a cross section of the final configuration of the main vessel supported by the stent graft, wherein a fenestration of the stent graft has been created by the side branch vessel fenestration creation device, shown in its opened configuration.
  • the invention provides a method for creating a fenestration in a stent graft at the point where the main vessel, in which the stent graft is placed, branches into a side branch vessel.
  • Figure 1 (prior art), which describes an aneurism 20 in a main vessel 200 that is close to the branching point 10 of the main vessel 200 and the side branch vessel 100.
  • a side branch vessel fenestration creation device is placed in the branch vessel so that the side branch vessel fenestration creation device protrudes into the lumen of the main vessel.
  • the stent graft is deployed in the main vessel.
  • a fenestration in the stent graft is created by the side branch vessel fenestration creation device, from the outer side of the stent graft, thereby allowing blood to flow through the stent graft, through the side branch vessel fenestration creation device and into the side branch vessel.
  • a fenestration is created at the branching point of the vessel using a side branch vessel fenestration creation device and any additional appropriate means.
  • the side branch vessel fenestration creation device marks the point where the fenestration is to be created, so that additional means may be inserted, or may in advance be inserted in order to aid in the creation of the fenestration.
  • the side branch vessel fenestration creation device has two configurations, the first referred to as the "closed configuration" and the second referred to as the "opened configuration".
  • the side branch vessel fenestration creation device is in an open configuration when at rest, and may be shaped into a closed configuration for insertion into a branch vessel.
  • the side branch vessel fenestration creation device may be "released" from its closed configuration into its pre-shaped, open configuration at the appropriate time through the appropriate means.
  • the side branch vessel may not be in need of a stent to support its structure, as a typical stent would do, and although the side branch vessel fenestration creation device may not actually function as a stent within the side branch vessel to support its structure, the side branch vessel fenestration creation device may be referred to -in the application as a stent, e.g., side branch vessel stent, due to its placement within the side branch vessel of the main vessel.
  • the side branch vessel fenestration creation device is placed in the branch vessel in the closed configuration, such that at least a portion of it protrudes into the lumen of the main vessel.
  • a portion of the side branch vessel fenestration creation device in the closed configuration punctures the stent graft, thereby enabling the creation of a fenestration in the stent graft at the point of branching of the blood vessel, thus allowing blood to continue its flow between the main vessel and the side branch vessel.
  • any appropriate means may be used to puncture the stent graft together with the side branch vessel fenestration creation device.
  • the side branch vessel fenestration creation device marks the point where the fenestration is to be created, so that additional means may be inserted or may in advance be inserted in order to aid in the creation of the fenestration.
  • the configuration of the side branch vessel fenestration creation device is changed to an opened configuration.
  • the configuration of the side branch vessel fenestration creation device is changed to the opened configuration by means of release of a mechanical lock, thus enabling the side branch vessel fenestration creation device to obtain a pre ⁇ shaped opened configuration.
  • the side branch vessel fenestration creation device changes its configuration to the opened configuration through the application of heat or by any other appropriate means. The heat may be applied by a catheter inserted into the vessel, or by any other appropriate means.
  • the side branch vessel fenestration creation device 1 10 includes two regions, the side branch vessel fenestration creation device body 1 1 1 and the side branch vessel fenestration creation device tip 1 12.
  • the side branch vessel fenestration creation device body 1 1 1 is tubular shaped and is placed in the side branch vessel.
  • the side branch vessel fenestration creation device body 1 1 1 is of any other appropriate shape suitable to be placed in the side branch vessel.
  • the side branch vessel fenestration creation device body 1 1 1 may include any appropriate means for anchoring the side branch vessel fenestration creation device 1 10 in the side branch vessel (not shown in figure).
  • the side branch vessel fenestration creation device body may include struts directed outwardly that will rest against the main vessel wall around the branched vessel ostium.
  • the side branch vessel fenestration creation device 1 10 is anchored in the side branch vessel in the closed configuration, and remains anchored therein also when changed to the opened configuration.
  • the side branch vessel fenestration creation device tip 1 12 is cone shaped in the closed configuration, as shown in Fig. 2. According to other embodiments (not shown in the figures), the side branch vessel fenestration creation device tip 112 has the shape of a tetrahedron in the closed configuration when viewed from the end. According to the invention, the side branch vessel fenestration creation device tip 112 may be of any appropriate shape in the closed configuration that enables the formation of a fenestration through the stent graft at the branching point of the blood vessel.
  • the side branch vessel fenestration creation device tip 1 12 comprises more than one finger 113, which form the shape of the closed configuration of the side branch vessel fenestration creation device tip, i.e., a cone, tetrahedron, etc.
  • the configuration of the fingers 1 13 is symmetrical, while according to other embodiments, it is not.
  • the side branch vessel fenestration creation device tip changes from a cone shape to a "sun-like" shape composed of several finger-like projections (or fingers) 1 13 that are spread out.
  • the fingers 1 13 serve the purpose of abutting the stent graft and the side wall of the main vessel, around the opening of the side branch vessel, so that the stent graft and the side wall of the main vessel remain touching one another around the fenestration.
  • the number of fingers 1 13 may be any appropriate number in order to fulfill this purpose. According to one embodiment, the number of fingers is between three and ten. According to another embodiment, the number of fingers 1 13 is between five and nine. According to another embodiment, the number of fingers 1 13 is between six and eight. According to another embodiment, the number of fingers 1 13 is six.
  • any other means may also be used for causing the stent graft to abut the side wall of the main vessel, around the opening of the side branch vessel, so that the stent graft and the side wall of the main vessel remain touching one another around the fenestration.
  • mechanical force may be applied from within the main stent graft so as to ensure that the stent graft and the side wall of the main vessel remain touching one another around the fenestration.
  • the side branch vessel fenestration creation device may be prepared from any appropriate composition, such as nitinol.
  • the nitinol side branch vessel fenestration creation device is at, or is close to, the phase transformation between austenitic and martensitic phases so that it will be completely transformed to the austenitic phase when heat (e.g., at a temperature range of approximately 38-45 °C) is applied to it.
  • the side branch vessel fenestration creation device may be formed of nitinol at more than one transformation phase.
  • the side branch vessel fenestration creation device body 1 1 1 is made of nitinol at the fully austenitic phase, while the side branch vessel fenestration creation device tip 1 12 is made of nitinol at a different metallurgic phase, such as the martensitic phase.
  • the side branch vessel fenestration creation device tip 1 12 is set at a metallurgic phase that is not fully martensitic and not fully austenitic.
  • the side branch vessel fenestration creation device 1 10 is placed in the side branch vessel 100 and set therein in such a way that the side branch vessel fenestration creation device tip 1 12 in its closed configuration protrudes into the lumen of the main vessel 200. Then, as depicted in Figure 5, once the stent graft 210 is deployed in the main vessel 200, the tip 1 12 of the side branch vessel fenestration creation device 1 10 protrudes into and creates a fenestration in the wall of the stent graft 210.
  • the side branch vessel fenestration creation device 110 is further transformed into its opened configuration, thus spreading fingers 113 and anchoring the stent graft 210 to the side wall of the main vessel 200, around the opening of the side branch vessel 100.
  • the invention further includes a method for treating a medical condition in a main vessel that is in close proximity of the branching of the main vessel, including the following steps:
  • the method of this invention further includes means of anchoring the side branch vessel fenestration creation device in the side branch vessel.
  • the method of this invention further includes means of causing the stent graft to abut the side wall of the main vessel around the opening of the side branch vessel, so that the stent graft and the side wall of the main vessel remain touching one another around the fenestration.
  • This invention further includes the use of a side branch vessel fenestration creation device to treat a medical condition in a main vessel that is in close proximity of the branching of the main vessel, comprising
  • a fenestration is created at the branching point of the vessel using the side branch vessel fenestration creation device and any additional appropriate means.
  • the side branch vessel fenestration creation device marks the point where the fenestration is to be created, so that additional means may be inserted to aid in the creation of the fenestration.
  • the use of a side branch vessel fenestration creation device to treat an aneurism that is in close proximity of the branching of the main vessel further includes means of anchoring the side branch vessel fenestration creation device in the side branch vessel.
  • the use of a side branch vessel fenestration creation device to treat an aneurism that is in close proximity of the branching of the main vessel further includes means of causing the stent graft to abut the side wall of the main vessel around the opening of the side branch vessel, so that the stent graft and the side wall of the main vessel remain touching one another around the fenestration.

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

Abstract

L'invention concerne un procédé qui permet la création d'une fenestration dans une endoprothèse en un point où le vaisseau principal dans lequel l'endoprothèse est placée se ramifie en un vaisseau latéral de ramification. Plus particulièrement, la fenestration est créée par perforation de l'endoprothèse depuis l'extérieur au moyen d'un stent de vaisseau latéral de ramification ou d'un dispositif de création de fenestration placé à l'intérieur du vaisseau latéral de ramification.
EP10832754.5A 2009-11-30 2010-11-30 Procédé pour implanter une endoprothèse et créer une fenestration dans ladite endoprothèse Withdrawn EP2506797A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US26484309P 2009-11-30 2009-11-30
PCT/IL2010/001001 WO2011064784A1 (fr) 2009-11-30 2010-11-30 Procédé pour implanter une endoprothèse et créer une fenestration dans ladite endoprothèse

Publications (2)

Publication Number Publication Date
EP2506797A1 true EP2506797A1 (fr) 2012-10-10
EP2506797A4 EP2506797A4 (fr) 2016-10-19

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EP10832754.5A Withdrawn EP2506797A4 (fr) 2009-11-30 2010-11-30 Procédé pour implanter une endoprothèse et créer une fenestration dans ladite endoprothèse

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Country Link
EP (1) EP2506797A4 (fr)
AU (1) AU2010325522A1 (fr)
CA (1) CA2782184A1 (fr)
WO (1) WO2011064784A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3989877A4 (fr) * 2019-06-25 2023-06-28 Biflow Medical Ltd. Endoprothèses vasculaires de perçage à ramification latérale pouvant être commandées

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2822370B1 (fr) * 2001-03-23 2004-03-05 Perouse Lab Endoprothese tubulaire comportant une bague deformable et necessaire d'intervention pour son implantation
US20040059406A1 (en) * 2002-09-20 2004-03-25 Cully Edward H. Medical device amenable to fenestration
US7691140B2 (en) * 2003-05-12 2010-04-06 Cook Incorporated Anastomosis device for vascular access
AU2006279305B2 (en) * 2005-08-18 2011-07-21 Cook Incorporated Design and assembly of fenestrated stent grafts
US20090228020A1 (en) * 2008-03-06 2009-09-10 Hansen Medical, Inc. In-situ graft fenestration
US20090264985A1 (en) * 2008-04-17 2009-10-22 Medtronic Vascular, Inc. Branch Vessel Suture Stent System and Method
US20090264990A1 (en) * 2008-04-21 2009-10-22 Medtronic Vascular, Inc. Radiopaque Imprinted Ink Marker for Stent Graft

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2011064784A1 *

Also Published As

Publication number Publication date
CA2782184A1 (fr) 2011-06-03
WO2011064784A1 (fr) 2011-06-03
EP2506797A4 (fr) 2016-10-19
AU2010325522A1 (en) 2012-07-05

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