US20170340462A1 - Stent grafts and methods of use for treating aneurysms - Google Patents

Stent grafts and methods of use for treating aneurysms Download PDF

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Publication number
US20170340462A1
US20170340462A1 US15/604,032 US201715604032A US2017340462A1 US 20170340462 A1 US20170340462 A1 US 20170340462A1 US 201715604032 A US201715604032 A US 201715604032A US 2017340462 A1 US2017340462 A1 US 2017340462A1
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Prior art keywords
graft
proximal
distal
tunnel
stent
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US15/604,032
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Timothy Lostetter
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Bolton Medical Inc
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Bolton Medical Inc
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Application filed by Bolton Medical Inc filed Critical Bolton Medical Inc
Priority to US15/604,032 priority Critical patent/US20170340462A1/en
Assigned to BOLTON MEDICAL, INC. reassignment BOLTON MEDICAL, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LOSTETTER, TIMOTHY
Publication of US20170340462A1 publication Critical patent/US20170340462A1/en
Priority to US16/507,314 priority patent/US11395750B2/en
Priority to US17/848,782 priority patent/US20220313459A1/en
Abandoned legal-status Critical Current

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    • 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
    • A61F2/82—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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/852—Two or more distinct overlapping stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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    • A—HUMAN NECESSITIES
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    • 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
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8486—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs provided on at least one of the ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • Suprarenal abdominal aortic aneurysms (AAA) and thoracoabdominal aortic aneurysms (TAAA) are life-threatening conditions that represent surgical challenges.
  • open surgical repair of these aneurysms can treat the diseased area of the aorta, there are considerable risks with open repair, primarily as a consequence of ischemic insult to the spinal cord, kidneys and surrounding abdominal viscera resulting from surgery.
  • open surgical techniques to repair suprarenal AAA and TAAA include distal aortic perfusion via extracorporeal circuits, in-line shunts, and cold renal perfusion to reduce the potential of ischemic injury to the spinal cord and renovisceral areas.
  • the present invention relates to stent grafts and methods of using stent grafts to treat aortic vascular damage, such as vascular damage associated with suprarenal AAA and TAAA, including aneurysms, penetrating ulcers and dissection.
  • aortic vascular damage such as vascular damage associated with suprarenal AAA and TAAA, including aneurysms, penetrating ulcers and dissection.
  • the invention is a stent graft comprising: a tubular aortic component defining a lumen having a proximal end, a distal end, a major longitudinal axis, and defining a fenestration between the proximal end and the distal end; a pocket at the fenestration, the pocket defining a pocket proximal opening and a pocket distal opening opposite the pocket proximal opening within the lumen; at least one proximal tunnel graft having a proximal tunnel graft proximal end, and at least one proximal tunnel graft distal end, and defining a proximal tunnel graft lumen, the proximal tunnel graft extending proximally within the lumen from the pocket proximal opening and being secured at its proximal end to the tubular aortic component; and at least one distal tunnel graft having a distal tunnel graft proximal end and
  • the invention is a method for treating a suprarenal or a thoracoabdominal aortic aneurysm.
  • a stent graft is delivered through an aorta to an aneurysm site of a patient, the stent graft being radially and releasably constrained by a distal end of a control catheter of a delivery device.
  • the stent graft includes: a tubular aortic component defining a lumen having a proximal end, a distal end, a major longitudinal axis, and defining a fenestration between the proximal end and the distal end; a pocket at the fenestration, the pocket defining a proximal opening and a distal opening opposite the proximal opening within the lumen; at least one proximal tunnel graft having a proximal tunnel graft proximal end and a proximal tunnel graft distal end, and defining at least one proximal tunnel graft lumen, the proximal tunnel graft extending proximally within the lumen from the proximal opening of the pocket and being secured at its proximal end to the tubular aortic component; and at least one distal tunnel graft having a distal tunnel graft proximal end and a distal tunnel graft distal end
  • the fenestration is aligned at the aneurysm site of the patient with at least one branch of the aorta at the aneurysm site.
  • the tubular aortic component (stent graft) is released from the delivery device, such as by retracting a control catheter of the delivery device.
  • Each of at least one branch stent graft is delivered through the distal end and the proximal end of the stent graft and through the distal tunnel graft or the proximal tunnel graft to the fenestration, and through the fenestration to a branch of the aorta at the aneurysm site of the patient, whereby the branch stent graft is secured into the distal tunnel graft lumen or the proximal tunnel graft lumen while being radially constrained at the opposite end of the branch stent graft by a branch delivery device.
  • Each branch stent graft is released from the branch delivery device to thereby complete implantation of the branch stent graft and treat the suprarenal or thoracoabdominal aortic aneurysm.
  • the stent grafts and methods of the invention have several advantages, including, for example, defining a fenestration that reduces the profile of the stent graft which, in turn, has the advantage of accommodating branch stent grafts within tunnel grafts to minimize the diameter of a prosthesis placed in a diseased aorta.
  • the length and diameter of the fenestration can be customized for individual patients depending upon the degree and extent of the suprarenal AAA and TAAA to permit the surgeon to minimize trauma in the area of the diseased aorta while providing the surgeon with a decreased profile for introducing branch stent grafts to branch vessels of organs and tissues in the area of the diseased aorta.
  • the stent grafts and methods of the invention also have the advantage of providing greater flexibility of choice to the surgeon introducing branch stent grafts, arranging them in either an antegrade or retrograde configuration, to accommodate the anatomical features specific to tissue surrounding the aneurysm.
  • antegrade is the flow of blood away from the heart and in the case of veins antegrade is the flow of blood towards the heart.
  • retrograde is the flow of blood towards the heart and in the case of veins retrograde is the flood of blood away from the heart.
  • antegrade placement of a branch stent graft in an aorta refers to the implantation of a branch stent graft that results in a portion of the branch stent graft extending from the fenestration in the tubular aortic component (stent graft with fenestration implanted in the aorta at the site of an aneurysm) in the same direction as the flow of blood.
  • retrograde placement of a branch stent graft in an aorta refers to the implantation of a branch stent graft that results in a portion of the branch stent graft extending from the fenestration in the aortic stent graft component in a direction that is opposite the flow of blood from the heart.
  • proximal and distal tunnel grafts are each secured to the aortic graft component at their proximal and distal ends, respectively.
  • implantation of branch stent grafts which, in abdominal aortic aneurysms or thoracoabdominal aortic aneurysm surgeries, must be through either the proximal or distal end of the aortic stent graft component, is facilitated by relatively stable positioning of the proximal end of the proximal tunnel graft and the distal end of the distal tunnel graft within the aortic stent graft component.
  • FIG. 1 is a side view of one embodiment of a stent graft of the invention.
  • FIG. 2A is a side view of another embodiment of a stent graft of the invention, like that of FIG. 1 but lacking a distal bare stent and rotated 90° about a major longitudinal axis.
  • FIG. 2B is a side view of the embodiment of FIG. 2A showing, in dashed-lines, a pocket and tunnel grafts within an aortic stent component of the invention.
  • FIG. 3A is a side view of another embodiment of a stent graft of the invention, wherein the proximal end of a proximal tunnel graft and a distal end of a distal tunnel graft of the embodiment are flared.
  • FIG. 3B is a side view of the embodiment of FIG. 3A rotated 90° about a major axis of the stent graft of the invention.
  • FIG. 4A is a side view of yet another embodiment of a stent graft of the invention after implantation at an aneurysm site in a subject, wherein the distal end of the aortic graft component is bifurcated.
  • FIG. 4B is a cross-sectional view of the embodiment of the stent graft of the invention shown in FIG. 4A taken along line 4 B- 4 B therein, and showing an end view of the proximal tunnel graft of FIG. 4A .
  • FIG. 5 is a side view of the stent graft of the invention of FIGS. 4A and 4B , and further including two branch stent grafts extending from the fenestration of the tubular aortic component of the invention after implantation at an aneurysm site in a subject.
  • FIG. 6A is a side view of another embodiment of a stent graft of the invention, having a bifurcated distal end, and wherein the proximal and distal tunnel grafts are partitioned into sublumens, as shown after implantation at an aneurysm site in a subject.
  • FIG. 6B is a cross sectional view of the embodiment of the stent graft of the invention shown in FIG. 6A taken along line 6 B- 6 B therein, and showing an end view of the sublumens of proximal tunnel graft of FIG. 6A .
  • FIG. 7 is a side view of the stent graft of the invention of FIGS. 6A and 6B , and further including four branch stent grafts extending from a fenestration of a tubular aortic component of the invention after implantation at an aneurysm site of a subject.
  • the invention is generally directed to prostheses for use in treating vascular disease, such as implantation of the prostheses at a site of an aortic aneurysm.
  • proximal means that portion of the prosthesis or component of the prosthesis that is relatively close to the heart of the patient and “distal” means that portion of the prosthesis or component of the prosthesis that is relatively far from the heart of the patient.
  • proximal means closer to the clinician using the delivery system.
  • distal means, when reference is made to a delivery system or a component of a delivery system, further away from the clinician using the delivery system.
  • proximate means “close to,” as opposed to the meanings ascribed to “proximal” or “distal” above with respect to either the vascular repair device or delivery system.
  • stent graft ( 10 ) includes tubular aortic component ( 12 ) defining a lumen having proximal end ( 14 ), distal end ( 16 ), major longitudinal axis ( 18 ), and defining fenestration ( 20 ) between proximal end ( 14 ) and distal end ( 16 ) of stent graft ( 10 ).
  • Tubular aortic component ( 12 ) is made from suitable materials, such as are known to those skilled in the art, including, for example, expanded polytetrafluoroethylene (PTFE), such as expanded PTFE (ePTFE), and polyethylene terephthalate (PET), such as woven polyester.
  • Fenestration ( 20 ) defines fenestration proximal end ( 22 ) and fenestration distal end ( 24 ).
  • Stents ( 26 ) extend about at least a portion of the circumference of tubular aortic component ( 12 ) between proximal end ( 14 ) and distal end ( 16 ).
  • Proximal bare stent ( 28 ) and distal bare stent ( 30 ) are secured to proximal end ( 14 ) and distal end ( 16 ), respectively.
  • Stents ( 26 ) and bare stents ( 28 , 30 ) are sutured to tubular aortic component ( 12 ) by suitable means known to those skilled in the art, such as by sutures ( 31 ), including sutures fabricated of polyester ePTFE (expanded polytetrafluoroethylene), polyglycolic acid, polylactic acid, monocryl and polydioxanone, non-absorbable nylon, polyester, PVDF (polyvinylidene difluoride) and polypropylene.
  • polyester ePTFE expanded polytetrafluoroethylene
  • polyglycolic acid polylactic acid
  • monocryl and polydioxanone non-absorbable nylon
  • polyester PVDF (polyvinylidene difluoride) and polypropy
  • Stents ( 26 ) and bare stents ( 28 , 30 ) are formed of a suitable material, such as is known to those skilled in the art, including nitinol.
  • Suitable radiographic markers ( 32 ) are sutured to periphery ( 34 ) of fenestration ( 20 ).
  • FIG. 2A is a side view of another embodiment of the invention.
  • stent graft 36 is like that of FIG. 1 , but, as shown, is rotated 90° about major longitudinal axis ( 18 ) and lacks distal bare stent ( 30 ).
  • FIG. 2B is a side view of the embodiment of the invention shown in FIG. 2A and shows components of the invention in outline (dashed-lines) that are within the lumen defined by tubular aortic component ( 12 ).
  • stent graft ( 36 ) includes pocket ( 38 ) at fenestration ( 20 ).
  • Pocket ( 38 ) defines pocket proximal opening ( 40 ) and pocket distal opening ( 42 ) opposite pocket proximal opening ( 40 ).
  • Pocket proximal opening ( 40 ) of pocket ( 38 ) lies in plane A that is located proximally to proximal end ( 22 ) of fenestration ( 20 ).
  • Pocket distal opening ( 42 ) lies in plane B located distally from distal end ( 24 ) of fenestration ( 20 ).
  • fenestration proximal end ( 22 ) lies in plane C
  • fenestration distal end ( 24 ) lies in a plane D. Both plane C and plane D are essentially orthogonal to major longitudinal axis ( 18 ) of tubular aortic component ( 12 ).
  • Plane A is parallel to and located proximal to plane C
  • plane B is parallel to and lies distal to plane D.
  • Proximal tunnel graft ( 44 ) of stent graft ( 36 ) has proximal tunnel graft proximal end ( 46 ), proximal tunnel graft distal end ( 48 ) and proximal tunnel graft lumen ( 50 ).
  • Proximal tunnel graft ( 44 ) extends proximally within the lumen of tubular aortic component ( 12 ) from pocket proximal opening ( 40 ) and is secured to proximal opening ( 40 ).
  • Stent graft ( 36 ) also includes distal tunnel graft ( 52 ) having distal tunnel graft proximal end ( 54 ), distal tunnel graft distal end ( 56 ) and distal tunnel graft lumen ( 58 ).
  • Distal tunnel graft ( 52 ) extends distally within the lumen of tubular aortic component ( 12 ) from pocket distal opening ( 42 ) and is secured to distal pocket opening ( 42 ).
  • proximal tunnel graft ( 44 ) and distal tunnel graft ( 52 ) is secured to an interior of tubular aorta component ( 12 ) by a suitable technique, such as is known to one skilled in the art, such as by a suture or biocompatible adhesive.
  • proximal end ( 46 ) of proximal tunnel graft ( 44 ) is fixed to tubular aortic component ( 12 ) by proximal suture ( 60 )
  • distal end ( 56 ) of distal tunnel graft ( 52 ) is fixed to tubular aortic component ( 12 ) by distal suture ( 61 ).
  • proximal tunnel graft ( 44 ) and distal tunnel graft ( 52 ) can be attached to tubular aortic component ( 12 ) by more than a single suture, such as along an intermittent or continuous length (not shown), over a portion or the entire length of proximal tunnel graft ( 44 ) and distal tunnel graft ( 52 ), respectively.
  • FIG. 3A is a side view of another embodiment of a stent graft of the invention.
  • stent graft ( 62 ) is like that of FIGS. 2A and 2B , except that stent graft ( 62 ) includes proximal tunnel graft ( 64 ) having proximal tunnel graft proximal end ( 66 ) that is flared.
  • Proximal tunnel graft ( 64 ) includes proximal tunnel graft stents ( 68 ) and stent graft ( 62 ) also includes distal tunnel graft ( 70 ) having distal tunnel graft distal end ( 56 ) that is flared.
  • FIG. 1 is a side view of another embodiment of a stent graft of the invention.
  • stent graft ( 62 ) is like that of FIGS. 2A and 2B , except that stent graft ( 62 ) includes proximal tunnel graft ( 64
  • 3B is a side view of tunnel graft ( 62 ) but rotated 90° about axis ( 18 ).
  • At least one stent ( 67 , 77 ) supports the flared opening of at least one of proximal end ( 66 ) and distal end ( 72 ), respectively.
  • At least one of fenestration proximal end ( 22 ) and fenestration distal end ( 24 ) of fenestration ( 20 ) lies in plane C, D, respectively, orthogonal to major longitudinal axis ( 18 ) and has a length, L, shown in FIG. 3B .
  • Length L is greater than the diameter of distal end ( 76 ) of the at least one proximal tunnel graft ( 64 ) or proximal end ( 78 ) of distal tunnel graft ( 70 ) extending from the respective proximal opening ( 40 ) and distal opening ( 42 ) of pocket ( 38 ).
  • FIG. 4A is a side view of another embodiment of a stent graft of the invention.
  • Stent graft ( 80 ) is like that of stent graft ( 62 ) in FIGS. 3A and 3B , but includes bifurcated distal end ( 82 ).
  • FIG. 4B is a cross-sectional view of stent graft 80 taken along line 4 B- 4 B, of FIG. 4A .
  • length L of the diameter of fenestration ( 20 ) is greater than that of diameter D of proximal tunnel graft ( 64 ) at proximal tunnel graft distal end ( 48 ).
  • FIG. 4A is a side view of another embodiment of a stent graft of the invention.
  • Stent graft ( 80 ) is like that of stent graft ( 62 ) in FIGS. 3A and 3B , but includes bifurcated distal end ( 82 ).
  • FIG. 4B is a
  • stent graft ( 80 ) is implanted in abdominal aortic aneurysm ( 84 ) of a subject, and further includes branch stent grafts ( 86 , 88 ), each implanted in a renal artery ( 90 , 92 ), respectively.
  • FIG. 6A is a side view of yet another embodiment of the stent graft of the invention.
  • stent graft ( 100 ) is like stent graft ( 80 ) of FIGS. 4A, 4B and 5 , but includes partitioned proximal tunnel graft ( 102 ) and partitioned distal tunnel graft ( 104 ). It is to be understood, however, that alternative embodiments are also possible, wherein only one or the other of proximal tunnel graft ( 102 ) or distal tunnel graft ( 104 ) is bifurcated.
  • Septums ( 106 , 108 ) partition each of the respective proximal and distal tunnel graft lumens ( 102 , 104 ) into two proximal sublumens ( 110 , 112 ) and distal sublumens ( 114 , 116 ).
  • Septums ( 106 , 108 ) partition each of the respective proximal and distal tunnel graft lumens ( 102 , 104 ) into two sublumens, to a point proximal or distal to openings of the respective tunnel graft lumens.
  • Each sublumen has a sublumen proximal end and sublumen distal end, respectively. As shown in FIG.
  • proximal tunnel graft septum can be formed by, for example, stitching proximal tunnel graft ( 102 ) along a center line to tubular aortic graft component ( 12 ) by stitching ( 118 ). It is to be understood that other methods of forming sublumens, such as are known in the art, can be employed in the alternative. For example, two parallel proximal or distal tunnel grafts can be employed instead of proximal and distal tunnel grafts that are stitched along a centerline to subdivide the lumens of each of them into sublumens.
  • branch stent grafts ( 120 , 122 , 124 , 126 ) extend through fenestration ( 20 ) and within at sublumens ( 110 , 112 , 114 and 116 ), respectively.
  • Branch stent grafts ( 120 , 122 , 124 , 126 ) extend from fenestration into renal arteries ( 90 , 92 ), celiac artery ( 130 ), and superior mesenteric artery ( 128 ), respectively.
  • the invention is a method for treating a suprarenal or thoracoabdominal aortic aneurysm.
  • stent graft is delivered through a femoral artery to aortic aneurysm site ( 84 ) of subject by radially and releasably constraining stent graft at the distal end of a control catheter of a delivery device (not shown).
  • the fenestration of the stent graft is aligned at aneurysm site ( 84 ) with at least one branch artery ( 90 , 92 , 128 , 130 ) at the aneurysm site ( 84 ), and then the stent graft is released from the delivery device and the delivery device is removed from the subject.
  • Each of at least one branch stent graft is releasably constrained by a branch delivery device.
  • Each branch stent graft ( 120 , 122 , 124 , 126 ) is delivered by a respective branch delivery device through a lumen of a tunnel graft of the stent graft and then through fenestration ( 20 ) to aneurysm site ( 84 ).
  • Branch stent grafts ( 120 , 122 , 124 , 126 ) extending from fenestration ( 20 ) are directed by the respective branch delivery device into a branch of the aorta at aneurysm site ( 84 ), and secured in a respective proximal or distal tunnel graft lumen at one end and within the branch artery at the opposite end.
  • Each branch stent graft is then released from the respective delivery device, which is then removed, thereby completing implantation and treating the suprarenal or thoracoabdominal aortic aneurysm.
  • Vascular repair devices of the invention can be implanted, for example, by transfemoral access. Additional vascular repair devices that are directed into the vascular repair devices of the invention can be implanted, for example, by supraaortic vessel access (e.g., through the brachial artery), or by transfemoral access or access from some other branch or branches of major blood vessels, including peripheral blood vessels.
  • supraaortic vessel access e.g., through the brachial artery

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CN109152639B (zh) 2022-03-29
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US20220313459A1 (en) 2022-10-06
US20190328557A1 (en) 2019-10-31
EP3463184B1 (en) 2021-12-22
JP2019516509A (ja) 2019-06-20
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US11395750B2 (en) 2022-07-26
JP6986522B2 (ja) 2021-12-22

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