WO2005112823A1 - Implantation percutanée d'endoprothèse vasculaire partiellement couverte dans des segments artériels dilatés de manière anévrismale avec embolisation et oblitération subséquentes de la cavité anévrismale - Google Patents

Implantation percutanée d'endoprothèse vasculaire partiellement couverte dans des segments artériels dilatés de manière anévrismale avec embolisation et oblitération subséquentes de la cavité anévrismale Download PDF

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Publication number
WO2005112823A1
WO2005112823A1 PCT/US2004/013884 US2004013884W WO2005112823A1 WO 2005112823 A1 WO2005112823 A1 WO 2005112823A1 US 2004013884 W US2004013884 W US 2004013884W WO 2005112823 A1 WO2005112823 A1 WO 2005112823A1
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Prior art keywords
stent
stents
bifurcation
aneurysm
proximal
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PCT/US2004/013884
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English (en)
Inventor
Richard W. Smalling
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The Board Of Regents Of The University Of Texas System
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Application filed by The Board Of Regents Of The University Of Texas System filed Critical The Board Of Regents Of The University Of Texas System
Priority to PCT/US2004/013884 priority Critical patent/WO2005112823A1/fr
Publication of WO2005112823A1 publication Critical patent/WO2005112823A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—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
    • A61F2/02—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
    • A61F2002/067—Y-shaped blood vessels modular
    • 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
    • A61F2/02—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
    • A61F2002/077—Stent-grafts having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
    • 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
    • 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
    • A61F2230/0034—D-shaped

Definitions

  • a stent is used to provide a prosthetic intraluminal wall, e.g., in the case of a stenosis to provide an unobstructed conduit for blood through the area of the stenosis.
  • An endoluminal prosthesis comprises a stent which carries a prosthetic graft layer of fabric or other material and is used in the instant invention to treat an aneurysm by removing the pressure on a weakened part of an artery so as to reduce the risk of distal embolization or rupture of the distended wall of the aneurysm.
  • a stent or endoluminal prosthesis is implanted in a blood vessel at the site of the aneurysm by minimally invasive techniques in which the stent is compressed along its long axis and is delivered by catheter to the site where it is required.
  • a cut down technique in which the blood vessel to be used as conduit is exposed by minor surgical means.
  • Various catheters or sheaths are inserted through small openings made in the conduit blood vessel. The stent is directed into the correct position and the catheter is withdrawn. The catheter's withdrawal allows the stent to re-expand to a predetermined diameter in the vessel.
  • a number of prostheses are known for treating the formation of aneurysms in bifurcated body lumens.
  • a typical previously practiced bifurcated prosthesis comprises a hollow tubular graft having a main section and first and second legs or extensions.
  • the main section of the prosthesis is sutured to the aorta below the renal arteries, and the first and second branches of the graft are sutured to the corresponding iliac arteries.
  • Surgical implantation of known prostheses poses a major risk of mortality and morbidity, and open surgical implantation frequently cannot be performed on patients in poor health.
  • grafts In attempts to overcome the drawbacks associated with surgically implanted grafts, a number of methods and devices have been developed to implant such grafts percutaneously.
  • Komberg, U.S. Pat. No. 4,562,596 describes a bifurcated graft for intraluminal, percutaneous implantation.
  • the graft comprises a hollow tubular main portion connected to a first leg and a shorter second leg.
  • the main portion includes a plurality of barbs that impale the healthy tissue of the aorta to maintain the graft in position.
  • Such grafts have a drawback in their inability to provide a fluid tight seal at the ends of the graft.
  • 5,961,548 describes a bifurcated graft, and methods of implantation that provide positive sealing between the graft and healthy tissue proximal and distal of the graft site.
  • Shmulewitz further describes methods of implantation of a bifurcated graft that enable smaller diameter delivery systems to be employed than are taught in the prior art as well as enhancement of the ease with which the legs of the graft may be deployed in the branches of a bifurcated body lumen.
  • the drawback presented in the graft and methods taught in Shmulewitz '548 is that the stent graft is covered, which has four major problems: (1) Covered stent grafts are 22F or greater and must be inserted by surgical cutdown due to the obligate nature of increased bulkiness of a stent covering combined with the metallic substrate being incompressible and, therefore, unable to be compressed below 22F. (2) Covering the stent graft completely eliminates blood flow to the side branches, such as the lumbars from the central lumen. This elimination of blood flow has produced paraplegia in animal models. However, retrograde collateral flow from the lumbars is not prevented.
  • the Rhodes prosthesis for aorto-iliac aneurysmal disease includes a common, stent supported sleeve section having an expandable outer balloon for engaging and trapping the thrombus in the aneurysmal space in the abdominal aorta, and a pair of stent- supported sleeve limb sections.
  • the limb sections are connected to the common section to provide a passage for blood to flow through the prostheses.
  • One or more of the limb sections can also include an outer balloon for engaging the thrombus within its associated aneurysmal space. Sealing mesh is provided on the prosthesis to prevent the egress of emboli and to permanently secure it in place.
  • the Rhodes prosthesis for aorto-iliac occlusive disease is similar to the prosthesis for aneurysmal disease, except that the sections of the prosthesis do not include an outer balloon.
  • the invention described by Rhodes presents several problems: (1) The device is bulky, including at least four superimposed layers with inner stent rings, an outside fabric covering, balloon material external to this fabric covering, and subsequently mesh or other thrombogenic material covering the balloon. This degree of bulkiness may preclude percutaneous delivery and requires surgical interventions for insertion. (2) The external balloon feature of this design is particularly problematic. In other applications with permanently implanted balloons (such as embolization balloons for treating large arterial venous malformations) the balloon material degrades and ruptures after several months to years post implant.
  • 5,720,735 discloses a device designed for treatment of stenotic or occlusive vascular disease in bifurcated segments. There are no implications for its use in aneurysmal disease as taught by the instant invention, particularly with regard to occlusion of the aneurysm cavity.
  • This device is designed to be deployed just below the renal arteries without retention hooks, thus allowing for axial dislodgment in the case of short necks of normal aorta immediately below the renal artery ostia. Without a direct application mechanism, and without adequate axial stability, this graft will have a tendency to suffer axial dislodgment with subsequent endo leaks, aneurysm expansion, and rupture.
  • the links in the stent material are not constructed from a solid tube and thus are prone to late fracture with subsequent penetration of the graft material which would permit leakage of blood into the aneurysm cavity, aneurysm expansion, and late rupture.
  • the short overlap segment of the bifurcation segments are not constructed from a solid tube and thus are prone to late fracture with subsequent penetration of the graft material which would permit leakage of blood into the aneurysm cavity, aneurysm expansion, and late rupture.
  • the proximal stent is not designed to cover the renal ostia; therefore, positioning this stent in patients with short necks below the renal arteries can be problematic and prone to axial migration and endoluminal leakage.
  • the bulkiness of the device precludes percutaneous delivery and it must be inserted using surgical cutdown techniques.
  • the commercial version most commonly utilized is not bifurcated and therefore the contralateral iliac is excluded from blood flow within the stent. This exclusion necessitates coil embolization of the contralateral vessel, followed by a surgical femoral-femoral bypass to the contralateral iliac, which is decidedly invasive.
  • the covered, non-permeable nature of the graft material could exclude side branches, providing further pressurization of the aneurysm cavity from the side branches, but, in addition, limiting antegrade blood flow through the side branches, which may lead to lumbar ischemia.
  • the semi-circular proximal segment is by definition in a tapered area of the aorta and, therefore, cannot achieve sufficient axial stability to maintain its position. It also has no longitudinal tapering which would help in preventing axial displacement.
  • Edoga U.S. Patent No. 5,591,228, teaches a device requiring insertion through a surgical incision, including left subclavian artery and bilateral femoral arteries.
  • the device entails graft material adherent to loose, large cell stents inside the proximal distal portions of the graft material. Problems include: (1) This device is bulky and cannot be inserted percutaneously. (2) It has ' poor axial stability since the proximal and distal limbs are fixed by stents, but there is loose graft material between the stents. (3) It will not be applicable for patients with small aneurysm necks below the renal arteries, or short aneurysm necks below the renal arteries. (4) The risk of graft material perforation secondary to fatigue fracture of the loose stent struts is excessive. This perforation could subsequently result in aneurysm expansion and late rupture.
  • Vortechnik et al U.S. Patent No. 5,562,724, discloses a design consisting of a porous bag attached to a proximal ring stent.
  • the bag is non-penetrable to blood and, therefore, cannot be crossed to embolize the surrounding aneurysm cavity.
  • Problems with this design include: (1) This design allows for poor axial stability given the short stent segment and the covered design therefore precluding placement above the renal arteries. Therefore, aneurysms with short necks will have a very short space for stabilization of the proximal portion. Axial migration will be prone to occur with subsequent severe endo leak, aneurysm expansion, and late rupture. (2) The legs are covered stents.
  • the present invention provides a main wire mesh stent or scaffold for placement in the lumen of a blood vessel with an aneurysm at or near a bifurcation in the vessel.
  • a particular example of the invention may be used in the abdominal aorta in patients with an abdominal aortic aneurysm.
  • DACRON ® tufts, bio-compatible foam or gel are bonded to the external surface of the stent to stimulate thrombosis of the aneurysm cavity and endothelialization of the graft lumen.
  • Radio-opaque markers delineate the margins of the partially covered regions on the stent and assist in placement of the elements of the stent in the appropriate position in the vessel proximate to the location of the aneurysm.
  • the present invention also comprises two bifurcation segments, or stents, comprised of a memory retentive material that is compressible to a first shape for insertion into the vessel and subsequent expansion in a position that substantially overlaps with and fits tightly within the main stent, with a larger profile above the bifurcation, acting like a "cork" to resist displacement and/or subsequent disassociation of the bifurcation stents.
  • Each of the bifurcation stents that comprise the present invention are configured in a semi-circular, half-cork type of configuration that is tapered at the level of the bifurcation to give the stent a frustroconical shape with the larger, proximal end being the end that expands into contact with the inside wall of the main stent, thereby preventing axial displacement.
  • Variable cell sizes openings in the stent wall are utilized to minimize obstruction to side branch flow proximally (at the level of the renal arteries) and to maximize internal laminar flow distal to the renal arteries.
  • Tapered, semi-circular, proximal orifices on the bifurcation stent elements optimize in-flow proximally and facilitate proximation and juncture with the main stent.
  • the stents expand to a tubular conformation, thus maximizing contact with the iliac lumens.
  • Angled guide-wires with marker bands are used to position the bifurcation stents and direct their deployment.
  • Radio-opaque markers on the bifurcation deployment sheath are used to insure proper alignment of the bifurcation stent elements.
  • Trans-stent placement of vascular occlusion coils, polymeric foams, gels or glues stimulates closure of the aneurysm cavity external to the stent assembly.
  • the small sheath size allows percutaneous closure of the vascular access sites in most patients, further reducing risks for bleeding complications, reducing both morbidity and time to ambulation.
  • the delivery of coils, or other thrombogenic material such as polymers, gels or glues, is guided angiographically or with intravascular ultrasound to insure obliteration of the aneurysm cavity external to the stent lumen.
  • Gradual thrombosis and fibrosis of the aneurysm cavity lead to shrinkage of the aneurysm cavity around the wire/steel, NITENOLTM reinforced aortic wall, which in turn will prevent later rupture of the aneurysm.
  • This safe and effective technique for percutaneous treatment of aortic aneurysms presents very low risk and enables preventive placement of the device in patients not previously considered good candidates for surgery, e.g., patients with small (less than four centimeter) aortic aneurysms or those with significant co-morbidities. It is therefore an object of the instant invention to provide a device specifically designed for treatment of an aneurysm of the descending aorta or other blood vessels with naturally occurring or traumatic (pseudo aneurysm) arterial bulging with the potential for either rupture or distal embolization.
  • the invention may be used in linear, curved or bifurcated vessels.
  • the invention presents a unique device and method for treating aneurysms particularly when an aneurysm occurs proximal to a bifurcation in a vessel. It is a further object of the instant invention to provide a device featuring an open or semi-permeable stent design, allowing for secure placement with stent overlap of normal aorta above the renal ostia.
  • the bifurcation segments of the instant invention are deployed across the bifurcation with significant increase in bifurcation segment size and significant overlap with the main stent above the bifurcation allowing for axial stability, which resists axial migration and late disruption.
  • stent grafts with non-permeable coverings predispose to perigraft leakage from branch vessels, which can lead to aneurysm expansion and late rupture, as well as the potential, at least in animal models, of lack of blood flow in the side branches of lumbars with subsequent paraplegia.
  • the open stent design with a semi-permeable covering of the instant invention allows for continued blood flow into the side branches that are immediately opposed to the stent, such as in the lumbar location.
  • Coil, gel or foam embolization of the remaining side branches can be utilized to prevent perigraft leakage such as at the level of the inferior mesenteric artery.
  • the instant device - and method are designed to facilitate deployment above the renal arteries without impeding flow into the renal arteries in the case of patients with a short segment of normal aorta below the renal arteries and in whom both iliacs are included in the bifurcation, precluding the need for concomitant vascular surgery.
  • the tapered segments thus form a stable union by virtue of their "cork-like" semi-conical configuration since when the segments are deployed in the main stent their wide, semi- circular ends contact each other with the flat end of the semi-circles in contiguity and the outward pressure of the segmental stent expansion maintains the rounded portion of the semi-circles against the walls of the main stent.
  • This pressure combined with the taper of each segment matching the taper of the distal aorta and exceeding the diameter of the iliac vessels prevents the segments from slipping distally in the stent and/or becoming dislodged.
  • the main stent configuration of the instant invention allows for placement of the initial, large-cell uncovered segment above the renal arteries for axial stability and a continuous stented segment to the bifurcation for further axial stability, which obviates the possibility of independent motion of the iliac branches. It is a further object of the instant invention to provide an aneurysmal repair device with a long stent segment, a portion of which, with large cell size, permits placement above the origins of the renal arteries for additional axial stability. The entire stent device is intact, therefore, there should be no possibility of axial migration. Additionally, the device of the instant invention is semi-permeable for both side branch continuity (i.e.
  • the instant invention described herein includes use of angled guide-wires which will minimize kinking of the legs during deployment. It is the further object of the instant invention to: (1) Allow percutaneous insertion and percutaneous suture closure of the arteriotomy due to the lack of a bulky covering of the stent.
  • the methods of the instant invention utilize a smaller percutaneous entry site, avoidance of side branch occlusion and slow, controlled fibrosis of the aneurysm cavity, reducing the risk for potential complications such as compromise of blood flow to the mesentery and spinal chord, late perigraft leaks and subsequent aneurysm expansion and late rupture.
  • This safe and effective technique for percutaneous treatment of aortic aneurysms presents very low risk and enables preventive placement of the device in patients not previously considered good candidates for surgery; e.g., patients with small (less than four centimeter) aortic aneurysms or those with significant co- morbidities.
  • FIG. 1A is a diagram of a preferred embodiment of an abdominal aortic stenting and aneurysm exclusion device composed of main and a first and second bifurcation stent constructed in accordance with the teachings of the present invention shown in place in the abdominal aorta.
  • Figure IB is a diagrammatic view of the main stent of the abdominal aortic stenting and aneurysm exclusion device of Figure 1A showing the internal wire mesh, radio-opaque marker band and outer tufts on the stent.
  • Figure 1C is a diagram showing the use of abdominal aortic stenting and aneurysm exclusion of Figure 1 A being used with an angiographic catheter for delivery of embolization coils, foam, gel or glue to the aneurysm cavity.
  • Figure 2A is a diagrammatic view of the first bifurcation stent of the abdominal aortic stenting and aneurysm exclusion device of Figure 1 A.
  • Figure 2B is a diagrammatic view of the second bifurcation stent of the abdominal aortic stenting and aneurysm exclusion device of Figure 1 A.
  • Figure 2C is a diagrammatic view of the first and second bifurcation stents abutting each other in the configuration achieved in the abdominal aortic stenting and aneurysm exclusion device of Figure 1 A.
  • Figure 3 is a schematic view of a bifurcation sheath delivery device for the abdominal aortic stenting and aneurysm exclusion device shown in Figure 1 A.
  • Figure 4 is a schematic view of the placement of the abdominal aortic stenting and aneurysm exclusion device marker delivery wires.
  • Figure 5A is a schematic diagram showing the implementation of arteriotomy closure strategies with sutures.
  • Figure 5B is a schematic diagram showing the implementation of arteriotomy closure strategies with collagen plugs or gel.
  • Figure 6A is a diagram of a second embodiment of the instant invention depicting a stenting and aneurysm exclusion device comprising a main stent and means for introduction of embolization coils into an aneurysm in an essentially linear blood vessel.
  • Figure 6B is a diagram of a second embodiment of the instant invention depicting a stenting and aneurysm exclusion comprising a main stent and means for introduction of embolization coils into an aneurysm in a curved blood vessel.
  • an endoluminal prosthesis comprising a stent graft which carries a prosthetic layer of fabric tufts, foam or other semi-permeable material to be used in treatment of an aneurysm by removing the pressure on a weakened part of the aneurysmally dilated wall of an artery so as to reduce the risk of embolism or rupture of the distended wall of the aneurysm.
  • the embodiments of the invention may be used in either bifurcated or non-bifurcated vessels.
  • Figure 1A depicts the use of the invention in a bifurcated vessel with an aneurysm 305.
  • the depicted location of the neck of the aneurysm 92 is representative only and may vary from case to case.
  • Figures 6A and 6B illustrate the use of the invention in non-bifurcated vessels with aneurysms 305.
  • Figure 1A shows the main stent 100 in place in the aorta 90.
  • the main stent 100 is comprised of an upper portion 110 with large cell size, allowing full, unrestricted blood flow into the renal arteries and a lower portion 140 with small cell size.
  • Cell size refers to the size of the spaces in the mesh pattern formed by the metal comprising the stent wall.
  • the border between the upper large cell size 110 and lower, small cell size 140 portion of the main stent 100 is demarcated by a radio-opaque marker band 190.
  • the total length of the main stent is chosen to extend a sufficient length so that the ends of the main stent 100 extend past the section of the vessel containing the aneurysm.
  • the small cell size portion 140 will extend from the level of the lower margin of the right 130 and left 120 renal arteries to the aortic bifurcation 97.
  • the main stent 100 section below the marker band 190 which is also termed the small cell size portion 140 is covered with biocompatible polymeric foam or DACRON®/other material 141 ( Figure IB) which promotes fibrin deposition and subsequent endothelialization along the stent surfaces.
  • This coating 141 is semi-permeable which allows trans-stent insertion of an angiographic or embolic material delivery catheter 410.
  • the semi-permeability of the coating 141 similarly allows insertion of thrombogenic material (coils, foam, gel, glue, etc.) 310 from the inner lumen of the stent through the stent cells and into the aneurysm cavity 305 using an angiographic or embolic material delivery catheter 410 as shown in Figures 1C, 6 A, or 6B.
  • Additional features depicted in Figure 1A include the infra renal aorta 95, the right 150 and left 160 iliac bifurcation stents, the right 170 and left 175 common iliac arteries, the right 171 and left 176 external iliac arteries, the right 172 and left 177 internal iliac arteries, the right 182 and left 183 common femoral arteries, the right 184 and left 185 profundus femori, the right 186 and left 187 superficial femoral arteries, and the right 192 and left 194 common vascular access sheaths.
  • the main stent 100 is inserted over a guiding wire 250.
  • a stent delivery device 200 which allows it to maintain a small crossing profile, permitting it to be inserted percutaneously through a vascular access hemostatic sheath 192 or 194 that is provided with hemostatic seals 193 and 195 and left 196 and right 197 side arms and stopcocks.
  • a vessel such as the abdominal aorta
  • the inner stent delivery tube 235 is fixed with respect to the patient while the outer sheath 230 is retracted.
  • the delivery wire 250 is left in position while the stent delivery system 200 is removed.
  • a second delivery wire 251 is then introduced via the left femoral artery access sheath 194.
  • the two delivery wires 250 and 251 are essentially parallel in the lumen of the aorta and diverge at the bifurcation point 97 with each delivery wire descending into the respective branching vessels.
  • two sectional (bifurcation) stent delivery sheaths 201 right 150 and left 160 iliac sectional (bifurcation) stents are advanced simultaneously over the delivery guide- wires 250 and 251.
  • the sectional (bifurcation) stents 150 and 160 have first, frustro-conically tapered proximal portions constructed with a large mesh size and second cylindrical distal portions constructed with a smaller mesh size than the proximal portions.
  • the mesh of the sectional stents is constructed of flexible wires or etched metal tubing defining a cell size in the proximal portions in the range from two (2) to four and one-half (4.5) millimeters and in the distal portions in the range from one and one-half (1.5) to three (3) millimeters.
  • the sectional (bifurcation) stents 150 and 160 range in total length from eight (8) to twelve (12) centimeters with the distal cylindrical portions, ranging in length from three (3) to five (5) centimeters.
  • the dimension of the widest part of the semi-circular shape of the proximal ends of the first 142 and the second 147 sectional (bifurcation) stents ranges from twenty (20) to thirty (30) millimeters with the tapered proximal portions (above the radio-opaque marker band 149) ranging in length from five (5) to seven (7) centimeters.
  • the portions of the proximal portions of the sectional stents are covered with a semipermeable coating ranging in length from one (1) to two (centimeters).
  • the diameter of the distal portions of the sectional (bifurcation) stents 150 and 160 range from twelve (12) to eighteen (18) millimeters.
  • the medial radio-opaque marker beads 210 and 211 are approximated on both sheaths by careful application of torque on the stent delivery devices 200 or 201 with fluoroscopic guidance. Subsequently, two operators independently fix the inner stent delivery tubes 235 on each bifurcation stent and the delivery sheaths 230 are withdrawn simultaneously in a continuous motion, allowing deployment of the bifurcation stents simultaneously with the flat or non-curvilinear portion 142 and 147 of the semi-circular wall of each bifurcation stent approximated in the middle of the main stent.
  • the semi-circular openings 143 and 146 join together, forming an optimal entrance of the blood flow into each iliac stent portion.
  • the radio-opr,que marker band on the bifurcation stent 149 is positioned at the aortic bifurcation prior to de-sheathing the iliac stents.
  • the semicircular openings expand against one another, with the lateral margins compressing against the main stent border and the medial, flat or non-curvilinear portions of the semi-circularly-shaped ends 142, 147 compressing against one another.
  • the simultaneous compression of the bifurcation stents inwardly against each other and outwardly against the inside wall of the main stent combined with the bifurcation stents' tapered conformation serve to affirmatively retain the bifurcation stents in position at the bifurcation and to resist dislocation, dislodgment or displacement.
  • the combination of semi-permeable coating 155 and the configuration of the stents allows for the formation of an impermeable hemostatic seal between the main stent 100 and the bifurcation stent lumens 150, 160. Thus, the risk of an endo leak at the bifurcation is effectively eliminated.
  • an angiographic guide catheter 400 is advanced via the vascular access sheath 192, superior to the bifurcation stent semi-circular openings 143 and 146 positioned in the small cell portion 140, immediately adjacent to the aneurysm cavity.
  • an angiographic catheter 410 is inserted through the angiographic guide catheter 400 and advanced through the main stent wall 100 into the aneurysm cavity 305. Its position is confirmed within the aneurysm cavity by injection of radio-opaque contrast and x-ray imaging. Subsequently, thrombogenic material (coils, foam, gel, glue, etc.
  • an operator achieves vascular access percutaneously via the right 182 and left 183 common femoral arteries and insert size twelve (12) french standard angiographic sheaths 192 and 194.
  • Control angiography is performed on the infra renal abdominal aorta 95 or other vessel with an aneurysm using standard techniques for guidance of the aneurysm stent implantation procedure.
  • a marker delivery wire 250 is inserted through the angiographic sheath 192 in the right common femoral artery 182 and positioned with the angle marker bead 260 positioned at the aortic bifurcation 97.
  • the distance between the lower most renal artery 120 or 130 and the aortic bifurcation 97 is noted using the marker delivery wire 250 and an appropriately sized main stent 100 is chosen for delivery.
  • the main stent delivery system 200 containing the main stent 100 is inserted with the distal radio-opaque stent fixation plug 225 at the leading end and hemostatic seal 231 at the trailing end and then advanced through the right iliac angiographic sheath 192 over the NITENOLTM marker delivery wire 250 and positioned with the radio-opaque marker band 190 just below the lower most renal artery 120 or 130, whichever is lowest, and the radio-opaque fixation disk 236 at the aorta bifurcation 97.
  • the main stent delivery sheath 230 is retracted, allowing the main stent 100 to expand and be deployed in the abdominal aorta 95.
  • the main stent delivery system 200 is removed over the right iliac marker delivery wire 250, which is left in position.
  • the left iliac marker delivery wire 251 is then advanced via the left common femoral hemostatic sheath 194 through the external and common iliacs and up the abdominal aorta 95 inside the main stent 100, thereupon positioning the angle marker bead 261 at the aortic bifurcation 97.
  • One bifurcation sheath delivery device 201 containing one bifurcation stent 150 is advanced over the right iliac guide-wire 250 and positioned so that the radio-opaque marker band 149 is at the aortic bifurcation and that the medial marker beads 210 and 220 are positioned medially in the aorta 95, just above the aortic bifurcation 97.
  • marker beards 211 and 221 are proximate the lower margin 96 of main stent 100.
  • a second, contra-lateral bifurcation stent 160 is advanced over the marker delivery wire 251 via the sheath 194 in the left femoral artery 183 into a position opposing the previously positioned right-sided iliac stent 150.
  • the marker band 149 is positioned at the aortic bifurcation 97 and the radio-opaque marker beads 210 and 220 on the bifurcation delivery sheath 200 are immediately opposed to those beads on the sheath delivery system 200 on the ipsilateral side 150.
  • the stent covering sheaths 230 and 232 are then simultaneously withdrawn over the inner stent delivery tubes 235 and 237 by two operators while the inner stent delivery tubes 235 and 237 are fixed in position, assuring that no axial migration occurs during stent deployment.
  • Withdrawing stent covering sheaths 230 and 231 allows the flat side of the tapered semi-circular bifurcation segments 142 and 147 on each side to oppose one another, forming a seal in the distal portion of the aorta 92 against each bifurcation stent medially and circumferentially against the main stent 100.
  • the iliac limbs 150 and 160 will then extend into the iliac vessels 170 and 175 bilaterally.
  • a standard angiographic right Judkins guiding catheter 400 is advanced over one of the stent delivery wires into the aorta 95 and positioned just opposite the main aneurysm sac 305.
  • the angiographic catheter 410 is advanced over the standard angiographic guide- wire into the aneurysm cavity 305.
  • Thrombogenic material 310 is then delivered via this standard angiographic guiding catheter 410 into the aneurysm cavity 305 in an amount sufficient to obliterate the residual aneurysm 300 surrounding the main stent 100.
  • a separate angiographic material delivery catheter 410 is placed in the aneurysm sac 305 adjacent to the main stent 100 and positioned so that thrombogenic material 310 can be delivered external to the stent 100.
  • the catheter 410 is withdrawn and the second marker delivery wire 251 could be replaced through the angiographic sheath 194 for delivery of the iliac stents 150 and 160.
  • the arteriotomy sites 440 are closed percutaneously using percutaneous closure devices (either suture based devices 420 or collagen plug type devices 450) to minimize risk of hematoma formation and/or blood loss.
  • percutaneous closure devices either suture based devices 420 or collagen plug type devices 450
  • the prosthetic stent combination, delivery apparatus and methods described above are particularly useful in treating an abdominal aortic aneurysm in a bifurcated vessel according to the present invention.
  • Other diseases and alternative embodiments of the prosthesis and delivery method will now be described. The parallels between the alternatives and the preferred embodiment will be apparent to one skilled in the art.
  • non-bifurcated stents constructed in accordance with the teachings of the present invention for treatment of an aneurysm in a non-bifurcated straight or curved vessel segment are shown at reference numerals 1100.
  • Each of the non-bifurcated stents 1100 are comprised of a flexible mesh or etched tubular material with small cell size.
  • Cell size refers to the size of the spaces in the mesh pattern formed by the metal comprising the stent wall.
  • the total length of the non-bifurcated stent is chosen to extend a sufficient length so that the ends of the stent extend past the section of the vessel containing the aneurysm.
  • the non-bifiircated stent 1100 is covered with biocompatible polymeric foam or DACRON® tufts/other semi-permeable material which promotes fibrin deposition and subsequent endotheUalization along the stent surfaces.
  • This coating is semi-permeable which allows trans stent insertion of an angiographic or embolic material delivery catheter 410.
  • the semipermeability similarly allows insertion of thrombogenic material (coils, foam, gel, glue, etc. 310, as may be seen in Figures 1A or 1C) from the inner stent lumen through the stent cells into the aneurysm cavity 305.
  • the non-bifurcated stent 1100 is inserted over a guiding wire 250 as shown in
  • Figure 3 It is initially housed in a stent delivery device 200 which allows it to maintain a small crossing profile, permitting it to be inserted percutaneously through a vascular access hemostatic sheath 192.
  • a stent delivery device 200 which allows it to maintain a small crossing profile, permitting it to be inserted percutaneously through a vascular access hemostatic sheath 192.
  • the inner stent delivery tube 235 is fixed with respect to the patient while the outer sheath 230 is retracted. This effectively uncovers the non-bifurcated stent 1100 allowing it to expand and oppose the normal vessel on either side of the aneurysm cavity 305.
  • the delivery wire 250 is left in position while the stent delivery system 200 is removed.
  • an angiographic guide catheter 400 is advanced via the vascular access sheath 192 and approximated against the medial non-bifiircated stent wall 1140, immediately adjacent to the aneurysm cavity. Numbering in the 1000's is used for the distinct non-bifiircated stents but not for the aneurysm related structure or the delivery apparatus.
  • an angiographic catheter 410 is inserted through the angiographic guide catheter 400 and advanced through non-bifurcated stent 1100 into the aneurysm cavity 305.
  • thrombogenic material (coils, foam, gel, glue, etc. 310) is injected into the aneurysm cavity 305 to stimulate thrombosis of the material external to the non-bifiircated stent 1100.
  • the access sites are closed, utilizing suture devices 425 and suture 430 or collagen plug devices 450 and collagen plugs 460 in the standard fashion.

Abstract

Un dispositif d'exclusion d'anévrisme aortique abdominal à profil bas avec extensions du vaisseau iliaque. Une endoprothèse vasculaire bifurquée transversale forme une partie d'une prothèse endoluminale pour éliminer ou réduire le risque de rupture d'anévrismes aortiques. Un appareil et un procédé pour introduire l'endoprothèse vasculaire bifurquée en partie dans le système sanguin et pour assembler ces parties in situ pour former un 'échafaudage' pour l'introduction de matériel pour ré-endothélialiser et/ou boucher la cavité anévrismale. Après embolisation trans-endoprothèse vasculaire de la cavité anévrismale avec un matériau thrombogénique, un flux laminaire stimule l'endothélialisation du lumen de l'endoprothèse vasculaire. L'organisation subséquente et la fibrose du thrombus persistant renforce le grillage ou l'échafaudage tubulaire métallique gravé comprenant l'endoprothèse vasculaire et sert à stabiliser et à réduire l'anévrisme. Une simple endoprothèse vasculaire déployée selon le même procédé peut être utilisée dans des vaisseaux non bifurqués.
PCT/US2004/013884 2004-05-04 2004-05-04 Implantation percutanée d'endoprothèse vasculaire partiellement couverte dans des segments artériels dilatés de manière anévrismale avec embolisation et oblitération subséquentes de la cavité anévrismale WO2005112823A1 (fr)

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EA012352B1 (ru) * 2007-01-17 2009-10-30 Ага Медикал Корпорейшн Доставляемый посредством катетера внутрисосудистый стент/имплантат для лечения сосудистых аномалий и способ лечения сосудистых аномалий
WO2011158045A1 (fr) * 2010-06-18 2011-12-22 Lombard Medical Limited Prothèse endoluminale
US8858613B2 (en) 2010-09-20 2014-10-14 Altura Medical, Inc. Stent graft delivery systems and associated methods
US9572652B2 (en) 2009-12-01 2017-02-21 Altura Medical, Inc. Modular endograft devices and associated systems and methods
EP2906144B1 (fr) * 2012-10-10 2017-08-02 TriVascular, Inc. Greffon endovasculaire pour anévrismes mettant en jeu des vaisseaux ramifiés principaux
US9737426B2 (en) 2013-03-15 2017-08-22 Altura Medical, Inc. Endograft device delivery systems and associated methods
EP3354230A1 (fr) * 2017-01-31 2018-08-01 Cook Medical Technologies LLC Endoprothèse bifurquée comportant une paroi de division d'écoulement sanguin hémodynamique
US10285833B2 (en) 2012-08-10 2019-05-14 Lombard Medical Limited Stent delivery systems and associated methods
US10857335B2 (en) 2017-02-13 2020-12-08 Daniel Ezra Walzman Temporary bypass balloon catheter
US10857328B2 (en) 2018-01-16 2020-12-08 Daniel Ezra Walzman Bypass catheter
CN112137761A (zh) * 2020-09-27 2020-12-29 中国医学科学院阜外医院 一种可视型术中支架输送装置及其术中支架系统
US10888414B2 (en) 2019-03-20 2021-01-12 inQB8 Medical Technologies, LLC Aortic dissection implant
US10926061B2 (en) 2018-01-16 2021-02-23 Daniel Ezra Walzman Bypass catheter
US11000672B2 (en) 2018-01-16 2021-05-11 Daniel Ezra Walzman Augmented bypass catheter
US11007048B2 (en) 2016-12-05 2021-05-18 Daniel Ezra Walzman Caped stent
US11006996B2 (en) 2018-01-16 2021-05-18 Daniel Ezra Walzman Torus balloon with energy emitters for intravascular lithotripsy
CN113558709A (zh) * 2021-09-22 2021-10-29 北京华脉泰科医疗器械股份有限公司 支架锚定区下移装置
US11559386B2 (en) 2017-07-07 2023-01-24 Endologix Llc Endovascular graft systems and methods for deployment in main and branch arteries
US11596438B2 (en) 2018-01-16 2023-03-07 Daniel Ezra Walzman Bypass catheter
US11596769B2 (en) 2018-01-16 2023-03-07 Daniel Ezra Walzman Bypass catheter
US11638655B2 (en) 2016-11-02 2023-05-02 Daniel Ezra Walzman Orientable intracranial occlusion device and method
US11723785B2 (en) 2016-12-05 2023-08-15 Daniel Ezra Walzman Orientable intracranial occlusion device and method

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EA012352B1 (ru) * 2007-01-17 2009-10-30 Ага Медикал Корпорейшн Доставляемый посредством катетера внутрисосудистый стент/имплантат для лечения сосудистых аномалий и способ лечения сосудистых аномалий
US9572652B2 (en) 2009-12-01 2017-02-21 Altura Medical, Inc. Modular endograft devices and associated systems and methods
WO2011158045A1 (fr) * 2010-06-18 2011-12-22 Lombard Medical Limited Prothèse endoluminale
US8858613B2 (en) 2010-09-20 2014-10-14 Altura Medical, Inc. Stent graft delivery systems and associated methods
US10285833B2 (en) 2012-08-10 2019-05-14 Lombard Medical Limited Stent delivery systems and associated methods
EP2906144B1 (fr) * 2012-10-10 2017-08-02 TriVascular, Inc. Greffon endovasculaire pour anévrismes mettant en jeu des vaisseaux ramifiés principaux
US9724186B2 (en) 2012-10-10 2017-08-08 Trivascular, Inc. Endovascular graft for aneurysms involving major branch vessels
US11717391B2 (en) 2012-10-10 2023-08-08 Trivascular, Inc. Endovascular graft for aneurysms involving major branch vessels
US9737426B2 (en) 2013-03-15 2017-08-22 Altura Medical, Inc. Endograft device delivery systems and associated methods
US11638655B2 (en) 2016-11-02 2023-05-02 Daniel Ezra Walzman Orientable intracranial occlusion device and method
US11723785B2 (en) 2016-12-05 2023-08-15 Daniel Ezra Walzman Orientable intracranial occlusion device and method
US11642213B2 (en) 2016-12-05 2023-05-09 Daniel Ezra Walzman Caped stent
US11007048B2 (en) 2016-12-05 2021-05-18 Daniel Ezra Walzman Caped stent
EP3354230A1 (fr) * 2017-01-31 2018-08-01 Cook Medical Technologies LLC Endoprothèse bifurquée comportant une paroi de division d'écoulement sanguin hémodynamique
US10646324B2 (en) 2017-01-31 2020-05-12 Cook Medical Technologies, LLC Bifurcated stent graft with hemodynamic blood flow dividing wall
US10857335B2 (en) 2017-02-13 2020-12-08 Daniel Ezra Walzman Temporary bypass balloon catheter
US11559386B2 (en) 2017-07-07 2023-01-24 Endologix Llc Endovascular graft systems and methods for deployment in main and branch arteries
US10926061B2 (en) 2018-01-16 2021-02-23 Daniel Ezra Walzman Bypass catheter
US11006996B2 (en) 2018-01-16 2021-05-18 Daniel Ezra Walzman Torus balloon with energy emitters for intravascular lithotripsy
US11564729B2 (en) 2018-01-16 2023-01-31 Daniel Ezra Walzman Torus balloon with energy emitters for intravascular lithotripsy
US11596438B2 (en) 2018-01-16 2023-03-07 Daniel Ezra Walzman Bypass catheter
US11596769B2 (en) 2018-01-16 2023-03-07 Daniel Ezra Walzman Bypass catheter
US11000672B2 (en) 2018-01-16 2021-05-11 Daniel Ezra Walzman Augmented bypass catheter
US10857328B2 (en) 2018-01-16 2020-12-08 Daniel Ezra Walzman Bypass catheter
US11738172B2 (en) 2018-01-16 2023-08-29 Daniel Ezra Walzman Bypass catheter
US10888414B2 (en) 2019-03-20 2021-01-12 inQB8 Medical Technologies, LLC Aortic dissection implant
CN112137761B (zh) * 2020-09-27 2023-06-06 中国医学科学院阜外医院 一种外科用可视型术中支架系统
CN112137761A (zh) * 2020-09-27 2020-12-29 中国医学科学院阜外医院 一种可视型术中支架输送装置及其术中支架系统
CN113558709A (zh) * 2021-09-22 2021-10-29 北京华脉泰科医疗器械股份有限公司 支架锚定区下移装置
CN113558709B (zh) * 2021-09-22 2021-12-28 北京华脉泰科医疗器械股份有限公司 支架锚定区下移装置

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