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WO2008107885A2 - Multi-component expandable supportive bifurcated endoluminal grafts and methods for using same - Google Patents

Multi-component expandable supportive bifurcated endoluminal grafts and methods for using same Download PDF

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Publication number
WO2008107885A2
WO2008107885A2 PCT/IL2008/000287 IL2008000287W WO2008107885A2 WO 2008107885 A2 WO2008107885 A2 WO 2008107885A2 IL 2008000287 W IL2008000287 W IL 2008000287W WO 2008107885 A2 WO2008107885 A2 WO 2008107885A2
Authority
WO
WIPO (PCT)
Prior art keywords
component
stent graft
graft system
section
main trunk
Prior art date
Application number
PCT/IL2008/000287
Other languages
French (fr)
Other versions
WO2008107885A3 (en
Inventor
Alon Shalev
Rafi Benary
Original Assignee
Alon Shalev
Rafi Benary
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Alon Shalev, Rafi Benary filed Critical Alon Shalev
Priority to CN2008800149199A priority Critical patent/CN101715329B/en
Priority to CA2679898A priority patent/CA2679898C/en
Priority to EP08719912.1A priority patent/EP2142142B1/en
Priority to US12/529,936 priority patent/US8317856B2/en
Priority to ES08719912.1T priority patent/ES2624595T3/en
Publication of WO2008107885A2 publication Critical patent/WO2008107885A2/en
Publication of WO2008107885A3 publication Critical patent/WO2008107885A3/en
Priority to US13/663,117 priority patent/US8709068B2/en

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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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/856—Single tubular stent with a side portal passage
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—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

Definitions

  • the present invention relates generally to endoluminal grafts, and particularly to bifurcated endoluminal grafts.
  • AAA abdominal aortic aneurysms
  • a major advantage in these newer devices is that their implantation involves a significantly less invasive procedure, including creating an endovascular working channel - usually via an incision in the groin area - to the diseased abdominal aorta, through which a self expandable stent-graft is typically introduced.
  • a bifurcated device is employed, either in one piece, or in some cases, smaller caliber iliac- grafts are deployed subsequently after the main aortic devices have been well positioned.
  • AAA stent grafts are implanted via two working channels, one in each side of the groin.
  • the interventional radiologist typically has to introduce one main piece of the device via one working channel and an extension piece through the other side in a non trivial manner.
  • AAA stent grafts • In earlier AAA stent grafts, device migration was a major issue, sometimes leading to obstruction of blood flow into the neighboring renal arteries or in other cases exposing the aneurysm to renewed blood penetration. Conventional AAA stent-grafts were typically prone to migration since they are essentially built along a single longitudinal axis and they may migrate along the same axis.
  • Endovascular leaks are another problem.
  • Two types of endoleaks are defined: A type I endoleak is leakage of blood around the stent-graft and into the aneurismal sac, which may lead to rupturing the aneurysm.
  • a Type II endoleak occurs when blood/plasma leaks through the graft wall and into the aneurismal space. Type II endoleaks have been mostly resolved by the introduction of finer-woven graft fabrics, performing pre-clotting procedures and/or incorporation of collagen or other procoagulation materials into the graft wall. Type I endoleaks are nonetheless more difficult to prevent and treat.
  • AAA stent-grafts are usually bifurcated grafts, one piece or multi-piece devices.
  • the connection with the graft fabric is typically achieved by hand stitching to a metallic, self-expandable frame. Hand labor related issues together with the critical QA/QC standards with which these devices have to comply make these devices quite expensive to manufacture.
  • the present invention seeks to provide novel bifurcated endoluminal grafts that overcome the abovementioned problems of the prior art, as described more in detail hereinbelow.
  • the present invention seeks to reduce the laborious and complicated multi- step medical procedures and related cost of the device.
  • the present invention involves significantly fewer, simpler, quicker and more definitive medical steps.
  • the present invention uses simpler device modules, which make the endovascular treatment of AAA quicker, safer for the patient and the treating staff, more reliable and cheaper.
  • the present invention can reduce the number of vascular access sites from two femoral arteries in both sides of the groin to a single vascular access site.
  • the present invention can reduce the risk of device migration in AAA stent grafts.
  • a stent graft system including a first component including a tubular structure having a support element and a covering element attached thereto, the first component being positionable in first and second branches that bridge a main trunk of a subject and wherein the first and second elements have an opening arranged to face the main trunk, and a second component having a generally cylindrical form with a support element and a covering element attached thereto, the second component configured to be at least partially disposed within the first component, outwardly extending from the opening in the first component.
  • One or both of the first and second components may be adapted for transluminal delivery for transport to a site within a body lumen by being radially compressed from a larger cross-section to a smaller cross-section.
  • the covering element of the first component only partially covers the support element of the first component.
  • the covering element of the second component only partially covers the support element of the second component.
  • the first and second components are radially compressible from a larger cross-section to a smaller cross- section, and wherein the first and second components are adapted for transluminal delivery for transport to a site within a body lumen, and wherein the second component is adapted for transluminal delivery through the first component in its larger cross-section and to outwardly extend from the opening in the first component.
  • the first component in its larger cross-section may be dimensioned to intralumenally fit iliac arteries of a subject and the second component in its larger cross-section may be dimensioned to intralumenally fit an abdominal aorta of the subject.
  • the second component includes a proximal segment and a distal segment, and wherein the covering element substantially spans the distal segment but does not generally span the proximal segment.
  • the proximal segment may be dimensioned to be anchorably disposed within the first component.
  • the proximal segment of the second component may be substantially disposed within the first component.
  • the distal segment of the second component may outwardly extend from the opening in the first component.
  • a method including implanting a stent graft system into a bifurcation in a body lumen, the bifurcation including a main trunk and first and second branches, wherein a first component of the system is disposed within the first and second branches bridging the main trunk and wherein the first and second elements have an opening aligned to face the main trunk, and implanting a second component in the main trunk such that at least a portion of the second component is located within the main trunk and at least a portion of the second component is located within the first component.
  • a multiple- component expandable endoluminal system for treating a lesion at a bifurcation including a self expandable tubular root member having a side-looking engagement aperture, a self expandable tubular trunk member including a substantially blood impervious polymeric liner secured therealong, both having a radially compressed state adapted for percutaneous intraluminal delivery and a radially expanded state adapted for endoluminal support, wherein root member and the trunk member are individually deployable, and wherein the trunk member is substantially non compressible along its longitudinal axis, and wherein the circumference of the side-looking engagement aperture is capable of having a substantially identical shape as the circumference of the body portion of the trunk member in its radially relaxed state, and wherein the trunk member is adapted to be inserted intraluminally through either ends of root member when in its deployable state and thereafter extraluminally substantially exiting through its side-looking engagement aperture and perpendicular thereto, and wherein the distal end of trunk member is adapted to
  • Fig. 1 is a simplified pictorial illustration of one possible insertion step in the deployment of an endoluminal graft in a non-limiting embodiment of the present invention
  • Fig. 2 is a simplified pictorial illustration of another deployment step of the endoluminal graft in a non-limiting embodiment of the present invention
  • Fig. 3 is a simplified pictorial illustration of a stent graft component of the endoluminal graft free of its catheter and positioned such that it has an open end located within each bifurcation branch and an aperture is facing the main trunk;
  • Fig. 4 is a simplified pictorial illustration of another deployment step of the endoluminal graft in a non-limiting embodiment of the present invention.
  • Fig. 5 is a simplified pictorial illustration of another deployment step of the endoluminal graft in a non-limiting embodiment of the present invention
  • Fig. 6 is a simplified pictorial illustration of the stent graft system in place in accordance with an embodiment of the present invention
  • Figs. 7-12 are simplified pictorial illustrations of another preferred embodiment of the present invention, wherein a catheter is inserted in a fashion similar to the embodiments of Figs. 4-6;
  • Fig. 13 is a simplified pictorial illustration of a non-limiting embodiment of an anchoring mechanism between first and second stent graft components
  • Fig. 14 is a simplified pictorial illustration of another non-limiting embodiment of an anchoring mechanism between stent graft components
  • Fig.l5A is a simplified pictorial illustration of a non-limiting embodiment of a stent graft component with an aperture evident in the graft material;
  • Fig. 15B and 15C are simplified pictorial illustrations of a non-limiting embodiment of stent graft component wherein the component includes sections with varying diameters;
  • Fig. 16A and 16B are simplified pictorial illustrations of the flow of blood through the joined stent graft components.
  • FIG. 1 illustrates one possible insertion step in the deployment of a component of an endoluminal graft in a non-limiting embodiment of the present invention.
  • a catheter 100 is percutaneously inserted into a bifurcation 12 (e.g., one iliac artery) extending from a main trunk 10, using conventional transluminal methods, such as with a guidewire 50.
  • the catheter 100 is bent or deflected at an angle so that it passes the main lumen and is then introduced into a second bifurcation 13 (e.g., the second iliac artery) extending from the main trunk 10.
  • Fig. 1 shows two branch arteries (arterial ostia) 14 and 15 branching from main trunk 10.
  • Catheter 100 includes two catheter portions 101 and 102.
  • Bifurcations 12 and 13 may also be referred to as arterial ostia 12 and 13.
  • Fig. 2 illustrates another deployment step of a component in a non-limiting embodiment of the present invention.
  • Both the distal and proximal ends of the catheter portions 101 and 102, respectively, are moved in opposite directions (e.g., by suitable manipulation of guide wires attached thereto, not shown) so that a stent graft component 60 which is in a compressed state within the catheter is gradually freed.
  • An aperture 61 in the stent graft component 60 is positioned by the operator (e.g., by suitable manipulation of a guide wire attached thereto, not shown, and assisted by imaging such as fluoroscopy) such that it faces the main trunk 10.
  • Fig. 3 illustrates the stent graft component 60 free of its catheter and positioned such that it has an open end located within each bifurcation 12 and 13 respectively, while aperture 61 is facing the main trunk 10.
  • FIG. 4 illustrates another deployment step of a component in a non-limiting embodiment of the present invention.
  • a second catheter 200 is inserted through one open end of the first stent graft component 60 so that its distal end extend through the aperture 61 in the first stent graft component and is located within the main trunk 10.
  • FIG. 5 illustrates another deployment step of a component in a non-limiting embodiment of the present invention.
  • a second stent graft component 70 is gradually freed from its restraining catheter.
  • Catheter outer tube 202 is withdrawn so that the stent graft component 70 is gradually free to expand in a radial direction, such that the graft component's distal end engages the walls of the main trunk 10 below arterial ostia 12 and 13, for example, the renal artery ostia.
  • the second stent graft component 70 As the second stent graft component 70 is freed from the circumferential confines of the outer catheter tube 202, its proximal end engages the first stent graft component 60, thus anchoring the second stent graft component 70 to the first stent graft component 60.
  • Fig. 6 schematically illustrates the stent graft system in place, with the second stent graft component 70 having one end engaged radially against the wall of the main trunk 10 under arterial ostia 12 and 13, while its proximal end is concentrically located within one end of the first stent graft component 60.
  • Figs. 7 through 12 illustrate another preferred embodiment of the present invention, wherein a catheter 70 is inserted in a fashion similar to the one described in Figs. 4, 5 and 6.
  • Stent graft component 70 is freed from its catheter 200 by retracting outer catheter tube 202 so that its distal end is free within the main trunk lumen.
  • the distal end of said second stent graft component 70 may or may not touch the lumen walls of the main trunk.
  • the proximal end of the second stent is located concentrically within one section of the first stent graft component 60 so that it is anchored by the first stent graft component.
  • a catheter 300 is inserted in a similar fashion through an open end of the first stent graft component 60, and through the proximal end of the second stent graft component 70 located concentrically within the first stent graft component 60.
  • Catheter 300 is inserted such that its proximal end extends beyond the open distal end of the second stent graft component 70.
  • a third stent graft component 80 is released from the catheter so that its distal end radially engages the lumen walls of the main trunk 10.
  • the third stent graft component 80 As the third stent graft component 80 is further released, its proximal end engages the second stent graft component 70 in a radial fashion, forming an anchoring point between the second stent graft component 70 and the third stent graft component 80.
  • Fig. 12 shows elements of stent graft component 80 engaging the lumen walls of main trunk 10 such that support elements 82 engage the lumen wall above arterial ostia 12 and 13. Graft covering 81 does not extend above the arterial ostia so as not to block blood flow into the ostia 14 and 15.
  • Fig. 13 schematically illustrates a non-limiting embodiment of the anchoring mechanism between the first stent graft component 60 and the second stent graft component 70.
  • engagement arms 73 and 74 are located circumferentially on the second stent graft component 70 in at least two rows above and below aperture 61 in stent graft component 60.
  • the rows of engagement arms 73 and 74 are formed so as to grasp both sides of aperture 61 in stent graft component 6O. The two stent graft components are joined together as a result.
  • Fig. 14 schematically illustrates another non-limiting embodiment of the anchoring mechanism between stent graft component 60 and stent graft component 70 whereby the proximal end of stent graft component 70 is concentrically located within at least a portion of stent graft component 60 with a section of the second stent graft component 70 extending through the aperture 61 and within a portion of stent graft component 60.
  • the graft covering 71 does not necessarily extend throughout the length of stent graft component 70.
  • Fig.l5A schematically illustrates a non-limiting embodiment of stent graft component 60 wherein aperture 61 is evident in the graft material covering component 61.
  • the graft covering 62 may be connected to support section 63 by means of sutures, adhesives or any suitable means.
  • Aperture 61 in the graft covering 62 may be equal in size to the aperture affected in support structure 63. Flaring may be introduced to component ends 65 in order to better engage a body lumen (not shown) when implanted.
  • Fig. 15B and 15C schematically illustrates a non-limiting embodiment of stent graft component 70 wherein component 70 may have include sections with varying diameters, so that a portion of component 70 may be deposited within a section of component 60 (not shown).
  • Fig. 15C shows another embodiment wherein circumferential engagement arms 74 may be formed so as to engage portions of component 60 (not shown) so as to anchor both components together.
  • Fig. 16A and 16B show the flow of blood through the joined stent graft components 60 and 70. It is important to allow blood flow to both sides of component 60 so as not to cause ischemia.
  • Fig. 16B illustrates that component 70 is not covered throughout by a graft covering so as to allow blood flow to both sides.

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  • Engineering & Computer Science (AREA)
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  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Transplantation (AREA)
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Abstract

A multiple-component expandable endoluminal system for treating a lesion at a bifurcation including a self expandable tubular root member having a side-looking engagement aperture, a self expandable tubular trunk member comprising a substantially blood impervious polymeric liner secured therealong; both having a radially compressed state adapted for percutaneous intraluminal delivery and a radially expanded state adapted for endoluminal support.

Description

MULTI-COMPONENT EXPANDABLE SUPPORTIVE BIFURCATED
ENDOLUMINAL GRAFTS AND METHODS FOR USING SAME
FIELD OF THE INVENTION
The present invention relates generally to endoluminal grafts, and particularly to bifurcated endoluminal grafts.
BACKGROUND OF THE INVENTION
For a few decades, conventional treatment of abdominal aortic aneurysms (AAA) was limited either to a sit-and-wait strategy, or in cases with too high a risk for aneurysm rupture, a surgical operation using vascular grafts introduced in major open abdominal surgery.
While long term clinical results of the surgical approach were favorable and the treated patients did not need frequent follow-ups, nevertheless the short-term morbidity, including complication rate, hospitalization time, out-of-work period and related expenses warranted continued search for a less invasive, but still definitive, solution of the problem.
Numerous attempts have been made to introduce such definitive treatments to AAA that involve less morbidity, a shorter hospitalization period and lower related costs, and enable the patient to return to routine life sooner. These initiatives resulted in various endovascular stent-grafts that are commercially available or are being clinically and pre- clinically evaluated. A major advantage in these newer devices is that their implantation involves a significantly less invasive procedure, including creating an endovascular working channel - usually via an incision in the groin area - to the diseased abdominal aorta, through which a self expandable stent-graft is typically introduced. In most cases, a bifurcated device is employed, either in one piece, or in some cases, smaller caliber iliac- grafts are deployed subsequently after the main aortic devices have been well positioned.
Nonetheless, the relatively new endovascular approach has its share of problems and limitations. Some of the major outstanding problems include:
■ The implantation is complicated because most AAA stent grafts are implanted via two working channels, one in each side of the groin. The interventional radiologist typically has to introduce one main piece of the device via one working channel and an extension piece through the other side in a non trivial manner.
■ There is a prolonged implantation procedure caused by a difficulty to correctly position the stent-graft and the inability to correct its position once deployed, usually due to barbs that penetrate the aortic wall and anchor the graft thereto. This also involves relatively high doses of X-ray radiation, to which the patient and the staff are exposed during the prolonged endovascular procedure.
• In earlier AAA stent grafts, device migration was a major issue, sometimes leading to obstruction of blood flow into the neighboring renal arteries or in other cases exposing the aneurysm to renewed blood penetration. Conventional AAA stent-grafts were typically prone to migration since they are essentially built along a single longitudinal axis and they may migrate along the same axis.
■ Endovascular leaks (in short - endoleaks) are another problem. Two types of endoleaks are defined: A type I endoleak is leakage of blood around the stent-graft and into the aneurismal sac, which may lead to rupturing the aneurysm. A Type II endoleak occurs when blood/plasma leaks through the graft wall and into the aneurismal space. Type II endoleaks have been mostly resolved by the introduction of finer-woven graft fabrics, performing pre-clotting procedures and/or incorporation of collagen or other procoagulation materials into the graft wall. Type I endoleaks are nonetheless more difficult to prevent and treat.
■ The device cost is very high. Current self-expandable AAA stent-grafts are usually bifurcated grafts, one piece or multi-piece devices. The connection with the graft fabric is typically achieved by hand stitching to a metallic, self-expandable frame. Hand labor related issues together with the critical QA/QC standards with which these devices have to comply make these devices quite expensive to manufacture.
■ There are the necessary follow-ups which are time consuming.
SUMMARY OF THE INVENTION
The present invention seeks to provide novel bifurcated endoluminal grafts that overcome the abovementioned problems of the prior art, as described more in detail hereinbelow. The present invention seeks to reduce the laborious and complicated multi- step medical procedures and related cost of the device. The present invention involves significantly fewer, simpler, quicker and more definitive medical steps. The present invention uses simpler device modules, which make the endovascular treatment of AAA quicker, safer for the patient and the treating staff, more reliable and cheaper.
The present invention can reduce the number of vascular access sites from two femoral arteries in both sides of the groin to a single vascular access site. The present invention can reduce the risk of device migration in AAA stent grafts.
There is provided in accordance with an embodiment of the invention a stent graft system including a first component including a tubular structure having a support element and a covering element attached thereto, the first component being positionable in first and second branches that bridge a main trunk of a subject and wherein the first and second elements have an opening arranged to face the main trunk, and a second component having a generally cylindrical form with a support element and a covering element attached thereto, the second component configured to be at least partially disposed within the first component, outwardly extending from the opening in the first component.
One or both of the first and second components may be adapted for transluminal delivery for transport to a site within a body lumen by being radially compressed from a larger cross-section to a smaller cross-section.
In accordance with an embodiment of the invention the covering element of the first component only partially covers the support element of the first component.
In accordance with an embodiment of the invention the covering element of the second component only partially covers the support element of the second component.
Further in accordance with an embodiment of the invention the first and second components are radially compressible from a larger cross-section to a smaller cross- section, and wherein the first and second components are adapted for transluminal delivery for transport to a site within a body lumen, and wherein the second component is adapted for transluminal delivery through the first component in its larger cross-section and to outwardly extend from the opening in the first component. For example, the first component in its larger cross-section may be dimensioned to intralumenally fit iliac arteries of a subject and the second component in its larger cross-section may be dimensioned to intralumenally fit an abdominal aorta of the subject.
In accordance with an embodiment of the invention the second component includes a proximal segment and a distal segment, and wherein the covering element substantially spans the distal segment but does not generally span the proximal segment. The proximal segment may be dimensioned to be anchorably disposed within the first component. The proximal segment of the second component may be substantially disposed within the first component. The distal segment of the second component may outwardly extend from the opening in the first component.
There is provided in accordance with an embodiment of the invention a method including implanting a stent graft system into a bifurcation in a body lumen, the bifurcation including a main trunk and first and second branches, wherein a first component of the system is disposed within the first and second branches bridging the main trunk and wherein the first and second elements have an opening aligned to face the main trunk, and implanting a second component in the main trunk such that at least a portion of the second component is located within the main trunk and at least a portion of the second component is located within the first component.
There is provided in accordance with an embodiment of the invention a multiple- component expandable endoluminal system for treating a lesion at a bifurcation including a self expandable tubular root member having a side-looking engagement aperture, a self expandable tubular trunk member including a substantially blood impervious polymeric liner secured therealong, both having a radially compressed state adapted for percutaneous intraluminal delivery and a radially expanded state adapted for endoluminal support, wherein root member and the trunk member are individually deployable, and wherein the trunk member is substantially non compressible along its longitudinal axis, and wherein the circumference of the side-looking engagement aperture is capable of having a substantially identical shape as the circumference of the body portion of the trunk member in its radially relaxed state, and wherein the trunk member is adapted to be inserted intraluminally through either ends of root member when in its deployable state and thereafter extraluminally substantially exiting through its side-looking engagement aperture and perpendicular thereto, and wherein the distal end of trunk member is adapted to be anchorably deployable through the side-looking engagement aperture. BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which:
Fig. 1 is a simplified pictorial illustration of one possible insertion step in the deployment of an endoluminal graft in a non-limiting embodiment of the present invention;
Fig. 2 is a simplified pictorial illustration of another deployment step of the endoluminal graft in a non-limiting embodiment of the present invention;
Fig. 3 is a simplified pictorial illustration of a stent graft component of the endoluminal graft free of its catheter and positioned such that it has an open end located within each bifurcation branch and an aperture is facing the main trunk;
Fig. 4 is a simplified pictorial illustration of another deployment step of the endoluminal graft in a non-limiting embodiment of the present invention;
Fig. 5 is a simplified pictorial illustration of another deployment step of the endoluminal graft in a non-limiting embodiment of the present invention; Fig. 6 is a simplified pictorial illustration of the stent graft system in place in accordance with an embodiment of the present invention;
Figs. 7-12 are simplified pictorial illustrations of another preferred embodiment of the present invention, wherein a catheter is inserted in a fashion similar to the embodiments of Figs. 4-6;
Fig. 13 is a simplified pictorial illustration of a non-limiting embodiment of an anchoring mechanism between first and second stent graft components;
Fig. 14 is a simplified pictorial illustration of another non-limiting embodiment of an anchoring mechanism between stent graft components;
Fig.l5A is a simplified pictorial illustration of a non-limiting embodiment of a stent graft component with an aperture evident in the graft material;
Fig. 15B and 15C are simplified pictorial illustrations of a non-limiting embodiment of stent graft component wherein the component includes sections with varying diameters; and
Fig. 16A and 16B are simplified pictorial illustrations of the flow of blood through the joined stent graft components.
DESCRIPTION OF EMBODIMENTS
Reference is now made to Fig. 1, which illustrates one possible insertion step in the deployment of a component of an endoluminal graft in a non-limiting embodiment of the present invention. A catheter 100 is percutaneously inserted into a bifurcation 12 (e.g., one iliac artery) extending from a main trunk 10, using conventional transluminal methods, such as with a guidewire 50. The catheter 100 is bent or deflected at an angle so that it passes the main lumen and is then introduced into a second bifurcation 13 (e.g., the second iliac artery) extending from the main trunk 10. Fig. 1 shows two branch arteries (arterial ostia) 14 and 15 branching from main trunk 10. There is an aneurysm 1 1 in the main trunk 10. Catheter 100 includes two catheter portions 101 and 102. Bifurcations 12 and 13 may also be referred to as arterial ostia 12 and 13.
Reference is now made to Fig. 2, which illustrates another deployment step of a component in a non-limiting embodiment of the present invention. Both the distal and proximal ends of the catheter portions 101 and 102, respectively, are moved in opposite directions (e.g., by suitable manipulation of guide wires attached thereto, not shown) so that a stent graft component 60 which is in a compressed state within the catheter is gradually freed. An aperture 61 in the stent graft component 60 is positioned by the operator (e.g., by suitable manipulation of a guide wire attached thereto, not shown, and assisted by imaging such as fluoroscopy) such that it faces the main trunk 10. Fig. 3 illustrates the stent graft component 60 free of its catheter and positioned such that it has an open end located within each bifurcation 12 and 13 respectively, while aperture 61 is facing the main trunk 10.
Reference is now made to Fig. 4, which illustrates another deployment step of a component in a non-limiting embodiment of the present invention. A second catheter 200 is inserted through one open end of the first stent graft component 60 so that its distal end extend through the aperture 61 in the first stent graft component and is located within the main trunk 10.
Reference is now made to Fig. 5, which illustrates another deployment step of a component in a non-limiting embodiment of the present invention. A second stent graft component 70 is gradually freed from its restraining catheter. Catheter outer tube 202 is withdrawn so that the stent graft component 70 is gradually free to expand in a radial direction, such that the graft component's distal end engages the walls of the main trunk 10 below arterial ostia 12 and 13, for example, the renal artery ostia. As the second stent graft component 70 is freed from the circumferential confines of the outer catheter tube 202, its proximal end engages the first stent graft component 60, thus anchoring the second stent graft component 70 to the first stent graft component 60.
Fig. 6 schematically illustrates the stent graft system in place, with the second stent graft component 70 having one end engaged radially against the wall of the main trunk 10 under arterial ostia 12 and 13, while its proximal end is concentrically located within one end of the first stent graft component 60.
Figs. 7 through 12 illustrate another preferred embodiment of the present invention, wherein a catheter 70 is inserted in a fashion similar to the one described in Figs. 4, 5 and 6. Stent graft component 70 is freed from its catheter 200 by retracting outer catheter tube 202 so that its distal end is free within the main trunk lumen. The distal end of said second stent graft component 70 may or may not touch the lumen walls of the main trunk. The proximal end of the second stent is located concentrically within one section of the first stent graft component 60 so that it is anchored by the first stent graft component. A catheter 300 is inserted in a similar fashion through an open end of the first stent graft component 60, and through the proximal end of the second stent graft component 70 located concentrically within the first stent graft component 60. Catheter 300 is inserted such that its proximal end extends beyond the open distal end of the second stent graft component 70. A third stent graft component 80 is released from the catheter so that its distal end radially engages the lumen walls of the main trunk 10. As the third stent graft component 80 is further released, its proximal end engages the second stent graft component 70 in a radial fashion, forming an anchoring point between the second stent graft component 70 and the third stent graft component 80.
Fig. 12 shows elements of stent graft component 80 engaging the lumen walls of main trunk 10 such that support elements 82 engage the lumen wall above arterial ostia 12 and 13. Graft covering 81 does not extend above the arterial ostia so as not to block blood flow into the ostia 14 and 15.
Fig. 13 schematically illustrates a non-limiting embodiment of the anchoring mechanism between the first stent graft component 60 and the second stent graft component 70. In this embodiment, engagement arms 73 and 74 are located circumferentially on the second stent graft component 70 in at least two rows above and below aperture 61 in stent graft component 60. The rows of engagement arms 73 and 74 are formed so as to grasp both sides of aperture 61 in stent graft component 6O.The two stent graft components are joined together as a result.
Fig. 14 schematically illustrates another non-limiting embodiment of the anchoring mechanism between stent graft component 60 and stent graft component 70 whereby the proximal end of stent graft component 70 is concentrically located within at least a portion of stent graft component 60 with a section of the second stent graft component 70 extending through the aperture 61 and within a portion of stent graft component 60. The graft covering 71 does not necessarily extend throughout the length of stent graft component 70.
Fig.l5A schematically illustrates a non-limiting embodiment of stent graft component 60 wherein aperture 61 is evident in the graft material covering component 61. The graft covering 62 may be connected to support section 63 by means of sutures, adhesives or any suitable means. Aperture 61 in the graft covering 62 may be equal in size to the aperture affected in support structure 63. Flaring may be introduced to component ends 65 in order to better engage a body lumen (not shown) when implanted.
Fig. 15B and 15C schematically illustrates a non-limiting embodiment of stent graft component 70 wherein component 70 may have include sections with varying diameters, so that a portion of component 70 may be deposited within a section of component 60 (not shown). Fig. 15C shows another embodiment wherein circumferential engagement arms 74 may be formed so as to engage portions of component 60 (not shown) so as to anchor both components together. Fig. 16A and 16B show the flow of blood through the joined stent graft components 60 and 70. It is important to allow blood flow to both sides of component 60 so as not to cause ischemia. Fig. 16B illustrates that component 70 is not covered throughout by a graft covering so as to allow blood flow to both sides.
The scope of the present invention includes both combinations and subcombinations of the features described hereinabove as well as modifications and variations thereof which would occur to a person of skill in the art upon reading the foregoing description and which are not in the prior art.

Claims

CLAIMS What is claimed is:
1. A stent graft system comprising: a first component comprising a tubular structure having a support element and a covering element attached thereto, said first component being positionable in first and second branches that bridge a main trunk of a subject and wherein said first and second elements have an opening arranged to face the main trunk; and a second component having a generally cylindrical form with a support element and a covering element attached thereto, said second component configured to be at least partially disposed within said first component, outwardly extending from said opening in said first component.
2. The stent graft system according to claim 1, wherein said first component is adapted for transluminal delivery for transport to a site within a body lumen by being radially compressed from a larger cross-section to a smaller cross-section.
3. The stent graft system according to claim 1, wherein said second component is adapted for transluminal delivery for transport to a site within a body lumen by being radially compressed from a larger cross-section to a smaller cross-section.
4. The stent graft system according to claim 1, wherein said covering element of said first component only partially covers said support element of said first component.
5. The stent graft system according to claim 1, wherein said covering element of said second component only partially covers said support element of said second component.
6. The stent graft system according to claim 1, wherein said first and second components are radially compressible from a larger cross-section to a smaller cross- section, and wherein said first and second components are adapted for transluminal delivery for transport to a site within a body lumen, and wherein said second component is adapted for transluminal delivery through said first component in its larger cross- section and to outwardly extend from said opening in said first component.
7. The stent graft system according to claim 6, wherein said first component in its larger cross-section is dimensioned to intralumenally fit iliac arteries of a subject and wherein said second component in its larger cross-section is dimensioned to intralumenally fit an abdominal aorta of the subject.
8. The stent graft system according to claim 1, wherein said second component comprises a proximal segment and a distal segment, and wherein said covering element substantially spans said distal segment but does not generally span said proximal segment.
9. The stent graft system according to claim 8, wherein said proximal segment is dimensioned to be anchorably disposed within said first component.
10. The stent graft system according to claim 8, wherein said proximal segment of said second component is substantially disposed within said first component.
11. The stent graft system according to claim 8, wherein said distal segment of said second component outwardly extends from said opening in said first component.
12. A method comprising: implanting a stent graft system into a bifurcation in a body lumen, said bifurcation comprising a main trunk and first and second branches, wherein a first component of said system is disposed within said first and second branches bridging the main trunk and wherein said first and second elements have an opening aligned to face the main trunk; and implanting a second component in the main trunk such that at least a portion of the second component is located within the main trunk and at least a portion of the second component is located within the first component.
13. The method according to claim 12, wherein said first component is generally cylindrical.
14. The method according to claim 12, wherein said second component is generally cylindrical.
15. The method according to claim 12, wherein said bifurcation in the body lumen comprises an aortoiliac bifurcation.
PCT/IL2008/000287 2007-03-05 2008-03-05 Multi-component expandable supportive bifurcated endoluminal grafts and methods for using same WO2008107885A2 (en)

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CN2008800149199A CN101715329B (en) 2007-03-05 2008-03-05 Multi-component expandable supportive bifurcated endoluminal grafts and methods for using same
CA2679898A CA2679898C (en) 2007-03-05 2008-03-05 Multi-component expandable supportive bifurcated endoluminal grafts and methods for using same
EP08719912.1A EP2142142B1 (en) 2007-03-05 2008-03-05 Multi-component expandable supportive bifurcated endoluminal grafts and methods for using same
US12/529,936 US8317856B2 (en) 2007-03-05 2008-03-05 Multi-component expandable supportive bifurcated endoluminal grafts and methods for using same
ES08719912.1T ES2624595T3 (en) 2007-03-05 2008-03-05 Bifurcated, supportive, expandable endoluminal grafts with multiple components and methods for use
US13/663,117 US8709068B2 (en) 2007-03-05 2012-10-29 Multi-component bifurcated stent-graft systems

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US89288507P 2007-03-05 2007-03-05
US60/892,885 2007-03-05
US99172607P 2007-12-02 2007-12-02
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US13/663,117 Continuation US8709068B2 (en) 2007-03-05 2012-10-29 Multi-component bifurcated stent-graft systems

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US20100063575A1 (en) 2010-03-11
US8317856B2 (en) 2012-11-27
EP2142142A4 (en) 2013-01-23
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WO2008107885A3 (en) 2010-02-18
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US20130090722A1 (en) 2013-04-11
US8709068B2 (en) 2014-04-29
CN101715329B (en) 2012-11-14

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