WO2015063780A2 - Dispositif et procédé permettant l'implantation d'une endoprothèse couverte et la création d'une fenestration dans ladite endoprothèse - Google Patents

Dispositif et procédé permettant l'implantation d'une endoprothèse couverte et la création d'une fenestration dans ladite endoprothèse Download PDF

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Publication number
WO2015063780A2
WO2015063780A2 PCT/IL2014/050957 IL2014050957W WO2015063780A2 WO 2015063780 A2 WO2015063780 A2 WO 2015063780A2 IL 2014050957 W IL2014050957 W IL 2014050957W WO 2015063780 A2 WO2015063780 A2 WO 2015063780A2
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WO
WIPO (PCT)
Prior art keywords
side branch
branch vessel
fenestration
vessel
stent graft
Prior art date
Application number
PCT/IL2014/050957
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English (en)
Other versions
WO2015063780A3 (fr
Inventor
Gregory FRENKLACH
Haim Ackerman
Joseph Flomenblit
Ron Livne
Original Assignee
Biflow Medical Ltd.
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Filing date
Publication date
Application filed by Biflow Medical Ltd. filed Critical Biflow Medical Ltd.
Publication of WO2015063780A2 publication Critical patent/WO2015063780A2/fr
Publication of WO2015063780A3 publication Critical patent/WO2015063780A3/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
    • A61F2/02—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
    • A61F2002/065—Y-shaped blood vessels
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular

Definitions

  • This invention is directed to a stent graft in which a fenestration may be formed, from the outside, by a side branch vessel fenestration creation device.
  • An aneurysm is a localized, blood-filled balloon-like bulge of a blood vessel, caused by the weakening of the vessel wall.
  • Aneurysm is an aortic aneurysm, which occurs in the main artery carrying blood from the left ventricle of the heart to the body. When the size of an aneurysm increases, there is a significant risk of rupture, resulting in severe hemorrhage, which may even lead to death.
  • Aneurysms 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, aneurysms.
  • aneurysms There are several published methods aiming at treating such aneurysms; however, they all suffer from various disadvantages.
  • One exemplary such method of treating such aneurysms 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 aneurysms 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.
  • endovascular conditions include atherosclerotic vessel stenosis, iatrogenic stricture of a vessel, external pressure causing vessel lumen narrowing, aneurysmal 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 aneurysm atherosclerotic vessel stenosis, iatrogenic stricture of a vessel, external pressure causing vessel lumen narrowing, aneurysmal 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.
  • Embodiments of the invention are directed to a side branch vessel device comprising two or more fingers, wherein at least two of the fingers have a hole, wherein the side branch vessel stent has:
  • the fixing element is threaded through the holes and extends beyond the holes, forming an extension.
  • at least one finger comprises a sharp edge, which, in the closed configuration, forms a sharp point.
  • a puncturing element is adjacent to the side branch vessel device.
  • the side branch vessel device further comprises at least one finger that is not fixed by the fixing element, such that it remains extended in the closed configuration.
  • the side branch vessel device is transformed from the closed to the opened configuration by removing the fixing element from the holes.
  • the fixing element is introduced via a sleeve.
  • Embodiments of the invention are directed to 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, the method including:
  • the extension has a sharp tip, edge or point.
  • the side branch vessel device comprises 4,6, 8 or 10 fingers.
  • the side branch vessel device comprises 8 fingers, four of which comprise holes through which the fixing element is inserted.
  • the side branch vessel device comprises 8 fingers, all of which comprise holes through which the fixing element is inserted.
  • the side branch vessel device comprises 8 fingers, four of which comprise sharp edges and holes through which the fixing element is inserted.
  • the side branch vessel device comprises 8 fingers, all of which comprise sharp edges and holes through which the fixing element is inserted.
  • the side branch vessel device comprises 8 fingers, all of which comprise sharp edges and holes through which the fixing element is inserted.
  • the side branch vessel device comprises 8 fingers, all of which comprise holes and four of which further comprise sharp edges.
  • FIG. 1 shows an example of a blood vessel with an aneurysm 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;
  • Fig. 7A provides two different embodiments of fingers having holes at their tips (or in close proximity to their tips);
  • Fig. 7B present three fingers having holes at their tips, placed one on top of the other;
  • Fig. 7C is a cross section of the tip of a side branch vessel device in the closed configuration, formed by introducing a fixing element into the holes of the fingers;
  • FIGs. 8A and 8B are cross sections of an embodiment of the invention, wherein the fenestration is formed by an extension of the fixing element;
  • FIGs. 9A and 9B are cross sections of an embodiment of the invention, wherein the wherein the fenestration is formed by a sharp point formed by the fingers;
  • FIGs. 10A and 10B are cross sections of an embodiment of the invention, wherein the fenestration is formed by a puncturing element;
  • Figs. 11 A, 11B and 11C present embodiments of the invention including some fingers that remain extended even in the closed configuration
  • Fig. 12 shows a cross section of the final configuration of the main vessel supported by the stent graft, wherein two fenestrations of the stent graft have been created by two separate side branch vessel fenestration creation devices and wherein the stent graft includes a region that is designed so that a fenestration may be formed, from the outside, by the side branch vessel fenestration creation devices.
  • 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 aneurysm 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 110 includes two regions, the side branch vessel fenestration creation device body 111 and the side branch vessel fenestration creation device tip 112.
  • the side branch vessel fenestration creation device body 111 is tubular shaped and is placed in the side branch vessel.
  • the side branch vessel fenestration creation device body 111 is of any other appropriate shape suitable to be placed in the side branch vessel.
  • the side branch vessel fenestration creation device body 111 may include any appropriate means for anchoring the side branch vessel fenestration creation device 110 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 110 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 112 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 112 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 113 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) 113 that are spread out.
  • the fingers 113 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 113 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 113 is between five and nine. According to another embodiment, the number of fingers 113 is between six and eight. According to another embodiment, the number of fingers 113 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 111 is made of nitinol at the fully austenitic phase, while the side branch vessel fenestration creation device tip 112 is made of nitinol at a different metallurgic phase, such as the martensitic phase.
  • the side branch vessel fenestration creation device tip 112 is set at a metallurgic phase that is not fully martensitic and not fully austenitic.
  • the side branch vessel fenestration creation device 110 is placed in the side branch vessel 100 and set therein in such a way that the side branch vessel fenestration creation device tip 112 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 112 of the side branch vessel fenestration creation device 110 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:
  • 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 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 aneurysm 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 aneurysm 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.
  • the invention is further directed to a stent graft in which a fenestration may be formed, from the outside, by a side branch vessel fenestration creation device. Further, once the fenestration is formed it is sealed by the side branch vessel fenestration creation device, by means of the stent graft itself, or by a combination thereof, so as to minimize blood leaks from around the fenestration back into the blood vessels. [0055] It should be understood that all of the embodiments detailed herein, relating to characteristics of the stent graft, are meant to include stent grafts in which only a region, several regions, a portion, several portions, an extension or several extensions thereof have the defined characteristics.
  • the stent graft is prepared from materials that enable the side branch vessel fenestration creation device to create a fenestration, from the outside, in the stent graft.
  • the stent graft is prepared from Teflon derivatives such as ePTFE, PTFE, or any combination thereof.
  • the stent graft is prepared from nitinol.
  • the stent graft is prepared from nitinol coated with Teflon derivatives such as ePTFE, PTFE, or any combination thereof.
  • the side wall of the stent graft is thin, so as to enable the side branch vessel fenestration creation device to create a fenestration, from the outside, in the stent graft.
  • the thickness of the side wall of the stent graft is less than 0.05mm.
  • the thickness of the side wall of the stent graft is less than 0.08mm.
  • the thickness of the side wall of the stent graft is less than 0.1mm
  • the thickness of the side wall of the stent graft is less than 0.03mm
  • the side wall of the stent graft is inelastic, so as to enable the side branch vessel fenestration creation device to create a fenestration, from the outside, in the stent graft.
  • FIG 12 shows a cross section of the final configuration of the main vessel (200), which, according to an embodiment of the invention is supported by stent graft (210), wherein two fenestrations of stent graft (210) have been created by two separate side branch vessel fenestration creation devices (110).
  • Stent graft (210) includes a region (220) that is designed so that a fenestration may be formed, from the outside, by the side branch vessel fenestration creation devices (110).
  • at least one fenestration in stent graft (210) is created by at least one side branch vessel fenestration creation device (110).
  • two fenestrations in stent graft are created by two separate side branch vessel fenestration creation devices (110).
  • the invention in some embodiments, is further directed to a kit comprising a side branch vessel fenestration creation device and a stent graft in which a fenestration may be created by the side branch vessel fenestration creation device.
  • the kit comprises any known stent graft in which a fenestration may be created by the side branch vessel fenestration creation device.
  • the kit comprises a stent graft specifically designed so that a fenestration may be created therein by the side branch vessel fenestration creation device, including any stent graft disclosed herein.
  • embodiments of the invention are directed to a method and device 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.
  • a side branch vessel device is placed in the branch vessel, so that a fenestration is made from the outside of the stent graft, either by the side branch vessel device or by other external means, and so that the side branch vessel device aids in anchoring the stent graft to the side wall of the main vessel, around the opening of the side branch vessel.
  • the side branch vessel device comprises means of anchoring it in the side branch vessel, such as rough areas, jags, spikes, corrugations, indentations, protruding elements, and the like, wherein the means of anchoring the side branch vessel device do not harm the vessel.
  • they means of anchoring may be flexible, soft, in a direction such that they do not harm the vessel, and the like.
  • the stent graft is deployed inside the main vessel.
  • a fenestration in the stent graft is created either by the side branch device or by other external means, from the outer side of the stent graft, thereby allowing blood to flow through the stent graft, through the side branch vessel device and into the side branch vessel.
  • a fenestration is created at the branching point of the vessel both by the side branch vessel device and by any additional appropriate means.
  • the side branch vessel device includes a body (such as 111 in Figure 2), a tip (112 in Figure 2) and fingers (113 in Figure 2).
  • the fingers are designed such that at least two of them include holes, through which a fixing element, such as a wire, twine, string, tube, or any other appropriate means, may be inserted.
  • at least one of the fingers includes a hole.
  • the diameter of the fixing element is approximately the same as that of the holes, such that once the fixing element is inserted through the holes it fits tightly in the holes and remains fixed (or clamped) in place within the hole, until external pressure is employed to remove the fixing element from the hole.
  • the hole includes a clamping element that prevents the fixing element from leaving the hole, without the aid of external pressure.
  • the initial (or natural) state of the side branch vessel device is an opened state, wherein at least part of the fingers are in an opened configuration (see Fig. 3 for example).
  • the fixing element may be used to hold at least two of the fingers of the side branch vessel device together, in order to form the side branch vessel tip, which may be sharp or blunt, thus transforming the side branch vessel device into the closed configuration.
  • the fixing element may be used to pull down one finger that comprises a sharp edge, such that, when pulled down, the sharp edge protrudes towards the stent graft, when deployed.
  • the holes are at the tips of the fingers.
  • FIG 7A showing different embodiments of the fingers 700 and 701, which have a hole 710 at their tips (or in the proximity thereof).
  • Figure 7B presents an example in which three such fingers (700, 701, 702), each having a hole 710 at its tip, wherein the three holes are placed one on top of the other.
  • a fixing element (not shown) may be inserted through those holes, which would keep the tips of the fingers together.
  • Figures 7A and 7B describe fingers that have a hole at the tip, leading to two "legs", each finger could be designed as desired (e.g., having one "leg” or more, having a sharp or blunt tip, having the hole lower on the finger, etc.). It is further noted that the same side vessel branch device may comprise more than one type of finger.
  • FIG. 7C is a cross section of the tip of a side branch vessel device in the closed configuration, which is formed by introducing fixing element 720 through sleeve 730 into a hole 710 in each of the two fingers 701 (shown are two fingers, though their number may vary according to different embodiments), such that fixing element 720 is inserted through each hole 710 of the presented fingers and such that sleeve 730 is not inserted through holes 710.
  • fixing element 720 fits tightly into holes 710, thus holding them firmly together.
  • fixing element 720 is clamped and held in at least one of holes 710 by any appropriate clamping means (not shown).
  • sleeve 730 is pushed against the tips of fingers 701, thus creating counter pressure that enables the removal of fixing element 720 from holes 710.
  • fingers 701 are released into the opened configuration (see, e.g., corrugated line presented for the left finger in Fig. 7C).
  • the holes are at the tips of the fingers, such that when the fingers are fixed together with a fixing element, the tip of the side branch vessel device is blunt, such that it cannot create a fenestration in the stent graft when the stent graft is deployed in the main vessel.
  • the end of the fixing element protruding through the holes in the fingers is designed such that it creates a fenestration in the stent graft when deployed in the main vessel.
  • FIG 8 A is a cross section of side branch vessel device 800, comprising tip 880, which is formed from fingers 801 (although two finger are shown, it is noted that any appropriate number of fingers, such as 3, 4, 5, 6, 7, 8, 9, 10 or more, may be used).
  • Fixing element 820 is introduced through sleeve 830, and is inserted through fingers 801, which have holes 810 at their tips, or close to their tips. According to this embodiment, fixing element 820 is inserted, or threaded, through holes 810, such that it extends beyond the holes, fonning extension 822.
  • Extension 822 is designed such that it may create a fenestration is the stent graft, when deployed. According to some embodiments, extension 822 has a sharp tip, edge or point.
  • Side branch vessel device 800 is anchored in the side branch vessel, such that at least part of tip 880 and extension 822 protrude into the lumen of the main vessel.
  • extension 822 creates a fenestration in the stent graft, which allows tip 880 to, at least partially, pass through the fenestration.
  • Fixing element 820 is then removed, which causes fingers 801 to move to the opened configuration, thus holding the position of the fenestration at the side branch vessel (not shown in Figure 8A, see, e.g., figure 6).
  • Figure 8B presenting a cross section of stent graft 210 during deployment in main vessel 200.
  • side branch vessel devices 800 were placed in the side branch vessels before the stent graft is deployed in the main vessel. Further, side branch vessel devices 800 are placed such that tip 880 protrudes into the lumen of main vessel 200.
  • the tip 880 of side branch vessel device 800 is held in the closed configuration by fixing element 820, which is introduced through sleeve 830 and is inserted into holes (not shown) at the tips (or close to the tips) of fingers 801.
  • Extension 822 of fixing element 820 protrudes further into the lumen of main vessel 200, and is designed so that when stent graft 210 is deployed, a fenestration is created therein by extension 822 (see the right hand side of Figure 8B). It is noted that extension 822 may be a part of fixing element 820 or may be an additional part or material attached thereto.
  • tip 880 passes through the fenestration and fixing element 820 is removed via sleeve 830, thus allowing fingers 801 to return to their opened configuration, as shown on the left side branch vessel in Figure 8B, and to thereby hold the fenestration in place, such that it is placed at the junction between main vessel 200 and the side branch vessel.
  • the holes are positioned at a mid-region of at least two fingers. It is noted that the mid-region is not limited to the exact middle of the finger; rather, the holes may be positioned at any desired position along the fingers of the side branch vessel device.
  • Figure 9C presenting an embodiment of finger 901 that ends with sharp edge 902 and includes hole 903.
  • hole 903 is attached to the finger 901 by way of shaft 904.
  • Figure 9A presenting a cross section of side branch vessel device 900, having tip 980 comprising fingers 901, wherein at least two fingers 901 comprise holes and sharp edges 902, which, when in the closed configuration, create sharp point 922.
  • any one of the fingers may comprise more than one sharp edge.
  • the closed configuration of the side branch vessel device is obtained by inserting fixing element 920, introduced through sleeve 930, into the holes of fingers 901. Sharp edges 902 on fingers 901 create sharp point 922 in the closed configuration.
  • fixing element 920 fits tightly into the holes (or at least one of them), such that only external pressure removes it therefrom
  • fixing element is clamped into at least one of the holes with a clamping element.
  • fixing element 920 is removed by external force from the holes of fingers 901.
  • sleeve 930 may create counter pressure on the fingers, such that fixing element 920 is removed from the holes through sleeve 930. Such counter pressure may be necessary, particularly when fixing element 920 fits tightly into the holes.
  • side branch vessel device 900 is anchored in the side branch vessel, so that at least a part of tip 980 and sharp point 922 protrude into the lumen of the main vessel. Accordingly, when the stent graft is deployed in the main vessel, sharp point 922 creates a fenestration in the stent graft, which allows tip 980 to, at least partially, pass through the fenestration. Fixing element 920 is them removed, which causes fingers 901 to move to the opened configuration, thus holding the position of the fenestration at the side branch vessel.
  • FIG. 9B presenting a cross section of stent graft 210 during deployment in main vessel 200.
  • side branch vessel devices 900 are placed in the side branch vessels before the stent graft is deployed in the main vessel. Further, side branch vessel devices 900 are placed such that tip 980 and sharp point 922 protrude into the lumen of the main vessel. Tip 980 of side branch vessel device 900 is held in the closed configuration by fixing element 920, which is introduced through sleeve 930, and is inserted into holes (not shown) on fingers 901.
  • Sharp point 922 is designed such that when stent graft 210 is deployed, a fenestration is created therein by sharp point 922(see the right hand side of Figure 9B). Once the fenestration is created, tip 980 passes through the fenestration (at least partially) and fixing element 920 is removed via sleeve 830, thus allowing fingers 901 to return to their opened configuration, as shown in the left side branch vessel in Figure 9B, and to thereby hold the fenestration in place, such that it is placed at the junction between main vessel 200 and the side branch vessel.
  • FIG 10A presenting a cross section of side branch vessel device 1000, having tip 1080 comprising fingers 1001, wherein at least two fingers 1001 comprise holes. It is noted that although only two fingers appear in the figure, the number of the fingers is not limited thereto and may be 3, 4, 5, 6, 7, 8, 9, 10 or more, provided that at least two of them include holes. According to other embodiments, only one finger comprises a hole. According to some embodiments, at least part of the fingers comprising holes are held in the closed configuration by inserting fixing element 1020, introduced through inner sleeve 1030, into the holes of fingers 1001.
  • fixing element 1020 fits tightly into the holes (or at least one of them), such that only external pressure removes it therefrom
  • fixing element is clamped into at least one of the holes with a clamping element.
  • fixing element 1020 is removed by external force from the holes of fingers 1001.
  • inner sleeve 1030 may create counter pressure on the fingers, such that fixing element 1020 is removed from the holes through inner sleeve 1030. Such counter pressure may be necessary, particularly when fixing element 1020 fits tightly into the holes.
  • side branch vessel device 1000 is placed in the side branch vessel before the stent graft is deployed. Further, also before a stent graft is deployed, a puncturing element is introduced in the approximate position, in the proximity of the tip of side branch vessel device 1000.
  • inner sleeve 1030 is part of outer sleeve 1050, which further comprises inner sleeve 1040.
  • sleeve 1040 may be introduced together with or separately from sleeve 1030 or may be inside sleeve 1030, as long as sleeve 1040 is introduced before the stent graft is deployed in the main vessel.
  • puncturing element 1022 is introduced through inner sleeve 1040 and is positioned in front of tip 1080.
  • Side branch vessel device 1000 is placed in the side branch vessel, such that at least part of puncturing element 1022 and tip 1080 protrude into the lumen of the main vessel. Accordingly, when the stent graft is deployed in the main vessel, puncturing element 1022 creates a fenestration in the stent graft, which allows tip 1080 to, at least partially, pass through the fenestration.
  • Fixing element 1020 is then removed, which causes finger 1001 to move to the opened configuration, thus holding the position of the fenestration at the side branch vessel.
  • FIG 10B presenting a cross section of stent graft 210 during deployment in main vessel 200.
  • side branch vessel devices 1000 are placed in the side branch vessels, together with puncturing element 1022, before the stent graft is deployed in the main vessel. Further, side branch vessel devices 1000 are placed such that tip 1080 and puncturing element 1022 protrude into the lumen of the main vessel. Tip 1080 of side branch vessel device 1000 is held in the closed configuration by fixing element 1020, which is introduced through inner sleeve 1030, and is inserted into holes (not shown) on fingers 1001.
  • Puncturing element 1022 introduced through inner sleeve 1040, is designed such that when stent graft 210 is deployed, a fenestration is created therein by puncturing element 1022 (see the right hand side of Figure 10B). Once the fenestration is created, tip 1080 passes through the fenestration (at least partially) and fixing element 1020 is removed via inner sleeve 1030, thus allowing fingers 1001 to return to their opened configuration, as shown in the left side branch vessel in Figure 10B, and to thereby hold the fenestration in place, such that it is placed at the junction between main vessel 200 and the side branch vessel. Puncturing element 1022 is removed through inner sleeve 1040 after the fenestration is created, either before or after transfonning the side branch vessel device 1000 from the closed to the opened configuration.
  • only part of the fingers include holes and therefore, in the closed configuration, only those fingers form the tip of the side branch vessel device, whereas the remaining fingers remain spread out, as in the opened configuration. According to such embodiments, the position of at least one finger does not change between the opened and closed configurations. According to further embodiments, the fixing element pass only through the holes of part of the fingers, such that the remaining fingers remain spread out as in the opened configuration.
  • the fingers that remain extended may prevent (or aid in preventing) the side branch vessel device from moving into the side branch vessel (away from the main vessel), causing the tip thereof, as well as any adjacent fenestration creating means, to move away from the lumen of the main vessel, such that the fenestration cannot be created or the tip cannot sufficiently pass therethrough.
  • the deployment of the main stent graft could cause the side branch vessel device to move back into the side branch vessel, possibly without the stent graft being punctured.
  • some embodiments are directed to side branch vessel devices designed so as to prevent such movement of the side branch vessel device.
  • FIG. 11 A, 11B and 11C presenting a side branch vessel devices similar to those described regarding Figures 8 A, 9A and 10A, respectively; further comprising fingers 811, 911 and 1011, respectively, which remain extended, as shown, even in the closed configuration.
  • any one of the elements and/or devices described may be prepared from any appropriate material, such as nitinol.
  • the side branch vessel device is a self-expandable or balloon expandable device.
  • the side branch vessel device is prepared from at least one biocompatible material.
  • different elements of the side branch vessel device are prepared from the same or different materials.
  • the body of the side branch vessel device and the tip thereof are prepared from the same or different material.
  • the fingers are prepared from the same or different material as the body of the side branch vessel device.
  • the different fingers are prepared from the same or different material.
  • the sharp edges on the fingers are prepared from the same or different material as the fingers.
  • the puncturing element is prepared from the same or different material as the side branch vessel device.
  • any one of the sleeves is prepared from a biocompatible material, such as silicon, silicon polymers, and the like.
  • the side branch vessel device or any elements thereof is prepared from steel, any appropriate alloy, such as nitinol and the like. Certain elements may be prepared from fabric, silicon, silicon polymers, polyurethanes, polytetrafiuoroethylene (PTFE), expanded PTFE (ePTFE), or any combination thereof.
  • any of the above embodiments may be combined, e.g., both extension 822 from Figure 8 A and puncturing element 1022 from Figure 10A, may be utilized together, in order to create an appropriate fenestration.
  • the fenestration of the stent graft occurs when the side branch vessel device is in the closed figuration. Therefore, either the side branch vessel device is placed in the side branch vessel in the closed configuration or otherwise, it is placed in the vessel in the opened configuration and transformed therein to the closed configuration, before the deployment of the stent graft in the main vessel.

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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

La présente invention concerne un dispositif pour vaisseau sanguin secondaire qui est placé dans le vaisseau sanguin secondaire avant le déploiement d'une endoprothèse couverte dans le vaisseau sanguin principal. Ledit dispositif pour vaisseau sanguin secondaire comprend un moyen de création d'une fenestration dans l'endoprothèse déployée ou, sinon, ledit moyen est introduit à proximité immédiate de celle-ci. Une fois l'endoprothèse couverte déployée, le dispositif pour vaisseau sanguin secondaire passe en configuration ouverte, ce qui aide à maintenir la fenestration à l'endroit où le vaisseau sanguin secondaire bifurque depuis le vaisseau sanguin principal.
PCT/IL2014/050957 2013-11-04 2014-11-04 Dispositif et procédé permettant l'implantation d'une endoprothèse couverte et la création d'une fenestration dans ladite endoprothèse WO2015063780A2 (fr)

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US201361899311P 2013-11-04 2013-11-04
US61/899,311 2013-11-04

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WO2015063780A2 true WO2015063780A2 (fr) 2015-05-07
WO2015063780A3 WO2015063780A3 (fr) 2015-06-25

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10729532B2 (en) 2017-02-14 2020-08-04 Cook Medical Technologies Llc Bifurcated prosthesis with an internal limb
US10772719B2 (en) 2017-02-14 2020-09-15 Cook Medical Technologies Llc Method of making a contoured internal limb for a prosthesis and prosthesis with a contoured internal limb

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2581857C (fr) * 2004-09-28 2013-07-16 William A. Cook Australia Pty. Ltd. Dispositif permettant de traiter les anevrismes dissequants
US20060190070A1 (en) * 2005-02-23 2006-08-24 Dieck Martin S Rail stent and methods of use
US8623005B2 (en) * 2007-10-01 2014-01-07 Baylis Medical Company Inc. Stent graft fenestration
DE102006058186A1 (de) * 2006-11-29 2008-06-05 Jotec Gmbh Proximale Fixierung
US20090125097A1 (en) * 2007-11-13 2009-05-14 Medtronic Vascular, Inc. Device and Method for Stent Graft Fenestration in Situ
US8157853B2 (en) * 2008-01-24 2012-04-17 Medtronic, Inc. Delivery systems and methods of implantation for prosthetic heart valves
US9358099B2 (en) * 2009-11-30 2016-06-07 Biflow Medical Ltd. Method of implanting a stent graft and creating a fenestration therein
FR2979229A1 (fr) * 2011-08-22 2013-03-01 Ct Hospitalier Universitaire Nimes Dispositif de fenestration d'endoprothese

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10729532B2 (en) 2017-02-14 2020-08-04 Cook Medical Technologies Llc Bifurcated prosthesis with an internal limb
US10772719B2 (en) 2017-02-14 2020-09-15 Cook Medical Technologies Llc Method of making a contoured internal limb for a prosthesis and prosthesis with a contoured internal limb

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