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
  • A61F2/95—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
  • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
  • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
  • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
  • A61F2/06—Blood vessels
  • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
  • A61F2/06—Blood vessels
  • A61F2002/065—Y-shaped blood vessels
  • 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
  • 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
  • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
  • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
  • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means
• • 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
  • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• • 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
  • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• • 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
  • A61F2230/0004—Rounded shapes, e.g. with rounded corners
  • A61F2230/0008—Rounded shapes, e.g. with rounded corners elliptical or oval
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2230/0063—Three-dimensional shapes
  • A61F2230/0067—Three-dimensional shapes conical
• • 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
  • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
  • A61F2310/00005—The prosthesis being constructed from a particular material

Definitions

• An aneurysm is an abnormal dilation of a layer or layers of an arterial wall, usually caused by a structural defect due to hardening of the artery walls or other systemic defects such as aortic dissection due to high blood pressure.
• the widely accepted approach to treating an aneurysm in the abdominal aorta i.e., an "abdominal aortic aneurysm" or "AAA" is by surgical repair, involving replacing the aneurysmal segment with a prosthetic device. This surgery is a major undertaking, with associated high risks and with significant mortality and morbidity.
• a typical surgical repair for AAA is performed by making an incision into the
• aorta Fig. 8A
• the aorta Once the aorta is accessible, it may be clamped to allow the surgeon to cut open the aorta and suture one graft end proximal to the heart. The other end of the graft is sutured to the aorta at a location past the aneurysm. This allows the blood flow from the heart to bypass the weakened area of the aorta.
• One alternative to the surgical repair is to use an endovascular procedure, i.e., catheter directed, techniques for the treatment of aneurysms, specifically for AAA.
• an endovascular procedure i.e., catheter directed, techniques for the treatment of aneurysms, specifically for AAA.
• This has been facilitated by the development of vascular stents, which can and have been used in conjunction with standard or thin-wall graft material in order to create a stent-graft or endograft.
• the potential advantages of less invasive treatments have included reduced surgical morbidity and mortality along with shorter hospital and intensive care unit stays.
• an endograft or endoprosthesis for AAA
• an infrarenal typically presents sufficient landing zones for the implant to achieve a tight seal between the inner surface of the vessel wall of the aorta and the outer surface of the endoprosthesis.
• the neck length is less than 15 mm, it is believed that complications may result from the use of an endoprosthesis designed for an infrarenal presentation.
• fenestrated technique relies on hand-made customized fenestrations to incorporate both the renal and superior mesenteric arteries into such bespoke endoprosthesis for juxtarenal to suprarenal AAAs.
• a physician can make openings or fenestrations by hand to an off-the-shelf AAA implant.
• physician modified fenestrated implants are that the implants are not FDA approved, requiring the physician to apply for a regulatory waiver and such fenestrated implants may take hours to make by the physician.
• manufacturers have provided customized fenestrated implant based on imaging of the aneurysm 6-12 weeks before the scheduled implant.
• one drawback to this technique is that a peculiar anatomy of the renal arteries may render the customized implant ineffective on the day of the implant procedure. For example, there may be an extra renal or hepatic artery involved, as well as renal arteries that are oriented upward. Additionally, the bespoke implants typically require a long-lead time by which time the anatomy of the AAA could have changed significantly resulting in branching arteries that do not align with the fenestrations.
• the invention provides for three key improvements: (1) ease of use in the simplification of deployment for one fenestration at a time; (2) in-situ alignment of each opening to the targeted branching artery resulting in improved clinical outcomes; and (3) the overall profile of the endoprosthesis is ultra-low (i.e., less than 16F for large native artery and in most cases, less than 12 French) because each portion of the endoprosthesis is smaller while requiring only one extra guidewire lumen.
• our inventive device includes two main portions.
• the first portion extends along a longitudinal axis and has a graft material defining a generally tubular graft that extends from a first portion inlet opening to first portion outlet opening, the first portion including a first peripheral opening formed on a peripheral surface of the generally tubular graft that defines a first peripheral scalloped opening to allow the scalloped opening peripheral opening to communicate with the inlet and outlet of the first portion.
• the second portion extends along the longitudinal axis and also has a graft material defining a second portion inlet opening to a trunk section that extends along the longitudinal axis to a bifurcation section.
• the bifurcation section has two limbs with respective limb outlet openings.
• each of the first and second portions comprises a plurality of stent hoops spaced apart from each other along the longitudinal axis and attached to a graft material to define a stent graft composite implant, each of the stent hoops having a sinusoidal configuration disposed about the longitudinal axis with apices spaced apart along the longitudinal axis; one apex of one stent hoop is disposed between two apices of another stent hoop; the generally tubular graft comprises a material selected from a group consisting of nylon, ePTFE, PTFE, Dacron and combinations thereof; the plurality of stent hoops are disposed on a peripheral inside surface of the stent-graft; a first peripheral opening is formed through the graft material about the longitudinal axis of the first portion proximate the first end so that the first peripheral opening communicates with a mesenteric artery when the first and second implants are deployed together in an abdominal artery; a second peripheral opening is formed through the
• Figure 1 illustrates a first main section 108 and a second main section 108 of the implant 100
• Figure 2 illustrates the limb extensions for the limbs of the trunk section 108
• Figure 4 illustrates in a perspective view of both sections 102 and 108 in the AAA presented as a juxtarenal AAA
• Figure 5 illustrates another variation of implant 100, indicated as 100' in which the peripheral openings for secondary arteries can be connected to the implant 100';
• Figures 6 illustrates a variation of the secondary section 108' with peripheral opening
• Figures 7A and 7B illustrate an exemplary delivery device for the implants shown and described
• Figure 8A illustrates a human abdominal aorta with the usual arteries branching
• Figure 8BI illustrates a presentation of an infrarenal AAA
• Figure 8BIII illustrates a presentation of a pararenal AAA
• Figure 8BIV illustrates a presentation of a suprarenal AAA
• the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ⁇ 50% of the recited value, e.g. “about 50%” may refer to the range of values from 51% to 99%.
• the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment.
• cranial or “caudal” are in this application are used to indicate a relative position or direction with respect to the person receiving the implant. As applied to “cranial,” the term indicates a position or direction closer to the heart, while the term “caudal” indicates a position or direction further away from the heart of such a subject.
• a first embodiment of an endovascular implant 100 is shown in Fig. 1 that can be used with limb extensions in EVAR procedures for AAAs that is other than infra-renal.
• the implant 100 can be used in AAA that categorized as juxtarenal, pararenal or suprarenal type AAAs due to its particular configuration.
• a first portion 102 (of the implant 100) is configured to extend along a longitudinal axis L-L.
• the first portion 102 may be made from a suitable bio-compatible graft material 102a such as, for example, a material selected from a group consisting of nylon, ePTFE, PTFE, Dacron and combinations thereof.
• the graft material 102a of the first portion 102 defines a generally tubular graft 103 that extends from a first portion's inlet opening 102b to first portion outlet opening 102c.
• the first portion 102 includes a first peripheral opening 104 formed on (and through) a peripheral surface of the generally tubular graft 103 to allow the first peripheral opening 104 to communicate with the inlet 102b and outlet 102c of the first portion 102.
• the implant 100 also includes a second portion 108.
• the second portion 108 extends along the longitudinal axis L-L and may include a graft material 108a, which can be selected from a suitable biocompatible material as noted earlier with respect to material 102a of the first portion 102.
• the graft material 108a by virtue of its design configuration, defines a second portion inlet opening 108b of a trunk section 112 that extends along the longitudinal axis L-L to a bifurcation section 114.
• the bifurcation 114 has two limbs 116, 118 with respective limb outlet openings 120, 122.
• the second portion 108 has a retention member 424 designed to be coupled (via a stent or hoop structure 126 to the inlet opening 108b. Similar to the first portion 102, two spaced apart peripheral openings 111, 110 are formed through the peripheral surface of the trunk section 112. This allows the spaced apart peripheral openings 111, 110 (of the second portion 108) to communicate with the trunk inlet 108b and limb outlets 120, 122 such that a radial alignment Rl of the first peripheral opening 104 (of the first portion 102) with respect to the radial alignment R2 of the second peripheral opening 111 (of the second portion 108) is achieved.
• second peripheral opening 106 is formed through the graft material 102a of the first portion 102 about the longitudinal axis L-L of the first portion 102 so that the peripheral openings 104 and 106 of the first portion 102 are aligned with the respective second peripheral openings 111, 110 of the second portion 108 and a pair of peripheral openings (104+111 as one pair and 106+110 as the other pair) communicates with respective renal arteries when the implant 100 is deployed in the abdominal artery.
• One benefit of the design in this embodiment is the ability to allow for renal arteries that are angulated upward due to the large size of the aneurysm.
• FIG. 5 A variation of the implant 100, denoted as 100', can be seen in Figure 5.
• the implant 100' is configured with a peripheral opening 131 to allow for insertion of the arterial stent graft extension 424 (Fig. 5).
• a third peripheral opening 130 (shown first in Fig. 1) can also be provided.
• the peripheral openings or fenestrations e.g., 106, 130, 131 etc., can be configured with sutures 500 threaded on the circumference of the fenestration 130 to provide for an initial small opening.
• Extra length 502 of the suture 500 can be provided at the end of the suture 500 to provide for slack to be built into the suture such that when the opening 130 or 131 is dilated, the slack 502 in the suture allows for enlargement of the fenestration to match a side branch artery of different diameters to the fenestration 130.
• the suture 500 can be configured with a predetermined slack length 502 to a lock stitch 504 to prevent over dilation of the peripheral opening 130.
• reinforcement in the form of another type of suture can also be provided on the circumference of the peripheral opening 130.
• Radiopaque markers can be disposed on the circumference of the peripheral opening (or interwoven into the suture 500) so that the physician can visualize the actual size of the fenestration 130 (or 106, 111, 131, etc).
• the peripheral openings can be dilated to the intended size in-situ (in the native artery) by insertion of a suitable dilation balloon catheter guided to the fenestration via guidewire GW2 (Fig. 7B). Upon reaching the fenestration, the balloon can be inflated gradually while being monitored via the markers of the fenestration.
• both the renal arteries are generally diametrical (e.g., approximately 150 degrees or more) with respect to the abdominal artery (or L-L axis)
• Second section 108' may have the peripheral opening 111 aligned with the other peripheral opening 130.
• section 108' may have other peripheral openings similar to opening 111 to allow for the formation of the appropriate conduit that allows flow from the implant 100 to the secondary arteries, depending on the presentation of the AAA.
• first peripheral opening 104 of the first portion 102 is
• the cut-out has three sides instead of four sides, as would be the case in a window-like arrangement.
• an arterial stent graft extension 424 can be used for insertion into peripheral openings 106, 111, or 130 so that side branch arteries (e.g., common hepatic, celiac, suprarenal, splenic and so on as shown in Fig. 8A) from the abdominal arteries can be incorporated into the flow of the implant 100.
• the arterial extension 424 has a suitable biocompatible graft material 424a similar to the graft material of the main portions noted earlier.
• the arterial extension 424 is configured as a generally tubular flow-through structure. In one embodiment, the extension 424 has a generally circular opening 424b at one end 425a.
• the extension 424 tapers from the first end 425a towards a smaller second generally circular extension opening 424c proximate the other end 425b.
• the arterial stent graft extension 424 is configured for insertion into at least one of the peripheral openings of the first and second portions with flared retainers provided proximate each end 425a and 425b to retain the arterial extension 424 to the main portions (102 or 108) of the implant 100 or the arterial vessel.
• each of the first and second portions 102, 108 may have a plurality of stent hoops 109 spaced apart from each other along the longitudinal axis L-L and attached to the graft material to define the preferred composite implant. It is noted that each of the stent hoops 109 has a sinusoidal configuration disposed about the longitudinal axis L-L with apices spaced apart along the longitudinal axis L-L.
• the stent hoops 109 are configured so that one apex of one stent hoop is disposed between two apices of another stent hoop.
• the plurality of stent hoops 109 are disposed on a peripheral inside surface of the stent-graft first portion 102 and stent graft second portion 108.
• the arterial extension may have at least one stent hoop 126 expandable to support the arterial stent graft 424a. That is, the stent hoop 126 can be a plurality of separate stent hoops connected to each other via the graft material.
• the stent hoop 126 is one stent being laser cut from a tube stock.
• the main trunk section 108 (or 108') can be deployed and then the first section 102 can be deployed thereafter such that a sufficiently tight seal is believed to be formed by the coupling of main trunk section 108 to the first section 102 at the junction where the aneurysm wall ("AW" arrows in Fig. 4) interfaces with the renal artery.
• A aneurysm wall
• the orientation of the peripheral openings 104 or 111 can be determined using a suitable imaging technique, such as for example, a fluoroscopic imaging system via the use of radiopaque markers affixed to the first and second implant portions. While the orientation of opening 104 can be of any orientation, it is usually the case that first scalloped peripheral opening 104 (of first portion 102) is generally aligned to the second peripheral opening 111 on the second portion 108.
• tubular stent graft extensions 130 are provided for insertion into each of the two limbs 116, 118 to allow for fluid flow from the inlet opening 102b of the first portion 102 through the second portion 108 to the respective limbs 116, 118 of the implant and out through each of the tubular stent graft extension 130.
• the stent graft implant e.g., implant 112 is moved to its intended location proximate the aneurysm by way of the inner sheath 608 following the first guide wire GW1.
• the outer sheath 604 can be pulled back (or the implant can be pushed out of the sheath 604) to expose the fenestration nub 612.
• the second guide wire GW2 can be manipulated (via translation or rotation of fenestration tube 606 about its longitudinal axis L-L) so that guide wire GW2 can enter into an arterial branch (e.g., a renal artery).
• Insertion of the second guidewire GW2 into the arterial branch will ensure that the peripheral opening (e.g., I l l) will adequately mate to the arterial branch.
• the second guide wire can be utilized for insertion of the arterial extension or bridging stent.
• the other implant portion(s) can be inserted into the desired position along the first guidewire GW1 and deployed so that the other implant portion(s) can be coupled to the first implant portion.
• an access point can be obtained at the femoral or peripheral artery and a catheter sheath can be inserted through the blood vessel to the AAA site.
• the second or main portion 108 is typically deployed first so that it forms a foundation on which to mount the remaining components.
• the main section 108 is rotated radially to allow communication of the appropriate side artery (e.g., mesenteric or renal) with the appropriate peripheral opening (e.g., I l l or 130).
• the first portion 102 can be partially deployed inside of the main section
• the limb extensions 130 can be inserted inside the limbs of the main section 108 and deployed.
• the AAA is presented as a juxtarenal type (Figs. 4 and 8BII)
• the device in Fig. 1 can be utilized and each of the separate portions (108 first then 102) can be partially deployed, rotated radially with respect to each other and then fully released to achieve the desired incorporation of the arteries in the body with the implant 100.
• All of the stent hoops described herein are substantially tubular elements that may be formed utilizing any number of techniques and any number of materials.
• all of the stent hoops are formed from a nickel -titanium alloy Nitinol, shape set laser cut tubing.
• the graft material utilized to cover all of the stent hoops may be made from any number of suitable biocompatible materials, including woven, knitted, sutured, extruded, or cast materials forming polyester, polytetrafluoroethylene, silicones, urethanes, and ultra-light weight polyethylene, such as that commercially available under the trade designation SPECTRATM.
• the materials may be porous or nonporous.
• Exemplary materials include a woven polyester fabric made from DACRO TM or other suitable PET-type polymers.
• the graft material is attached to each of the stent hoops.
• the graft material may be attached to the stent hoops in any number of suitable ways.
• the graft material is attached to the stent hoops by sutures.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Cardiology (AREA)
• Vascular Medicine (AREA)
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