WO2018134368A1 - Greffon de stent de préservation aorto-iliaque monolithique - Google Patents

Greffon de stent de préservation aorto-iliaque monolithique Download PDF

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Publication number
WO2018134368A1
WO2018134368A1 PCT/EP2018/051342 EP2018051342W WO2018134368A1 WO 2018134368 A1 WO2018134368 A1 WO 2018134368A1 EP 2018051342 W EP2018051342 W EP 2018051342W WO 2018134368 A1 WO2018134368 A1 WO 2018134368A1
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WO
WIPO (PCT)
Prior art keywords
leg
stent graft
aorto
iliac
lumen
Prior art date
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PCT/EP2018/051342
Other languages
English (en)
Inventor
Stevo DUVNJAK
Original Assignee
Syddansk Universitet
Region Syddanmark
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.)
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Application filed by Syddansk Universitet, Region Syddanmark filed Critical Syddansk Universitet
Publication of WO2018134368A1 publication Critical patent/WO2018134368A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—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
    • 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
    • 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

  • the present invention relates to a stent graft and in particular relates to an aorto- iliac preservation stent graft for treatment of aorto-iliac aneurysms and a corresponding stent graft assembly and method.
  • Solutions such as stent grafts (such as branched stent grafts) or stent graft assemblies, exist for treatment of aorto-iliac aneurysms.
  • these solutions may have anatomical restriction and/or other disadvantages, so in about 40-50% of the cases treatment is or could be limited with these solutions.
  • an improved aorto-iliac preservation stent graft would be advantageous, and in particular an aorto-iliac preservation stent graft which would make it possible to preserve internal iliac artery in more patients, such as in a majority of patients, would be advantageous.
  • an aorto-iliac preservation stent graft for, such as suitable for, such as arranged for, treatment of aorto-iliac aneurysms, said aorto-iliac preservation stent graft comprising :
  • proximal end portion with a proximal opening at a proximal end
  • a main lumen extending between the proximal end and the distal end such as said main lumen extending from the proximal end to the distal end of the main body, such as wherein the distal end of the main body is coincident with the bifurcation, such as the coincident with the first and second bifurcation opening,
  • a first leg such as an ipsilateral leg, extending distally from the first bifurcation opening, such as extending in a direction away from the main body,
  • first leg comprises a first lumen in fluid communication with the main lumen
  • At least a tapered portion of the first leg is tapered with a cross-sectional area increasing in a direction away from the main body
  • At least a distal end portion of the first leg comprises: i. A primary interior lumen suitable for connection to a leg
  • leg extension such as said leg extension being suitable for entering into a first external iliac artery, ii .
  • a secondary interior lumen suitable for connection to a stent graft extension such as said stent graft extension being suitable for entering into a first internal iliac artery,
  • a second leg such as a contralateral leg, extending from the second bifurcation opening in a direction away from the main body, wherein a first leg length is larger than a second leg length, such as the first leg length is larger than the second leg length and a difference between the first leg length and the second leg length is 1 mm or more, such as 2 mm or more, such as 5 mm or more, such as 10 mm or more, such as 15 mm or more, such as within 15-20 mm,
  • graft material of the main body, the first leg and the second leg form a monolithic unit of biocompatible g raft material .
  • the invention is particularly, but not exclusively, advantageous for obtaining a stent g raft, which makes it possible to preserve internal iliac artery in more patients, such as in a majority of the patients.
  • new inventive stent graft can allow preservation of the internal iliac artery in a case where there is ectasia or aneurysm of the common iliac artery. This is about 20-30% of the patients with aortic aneurysms.
  • the aorto-iliac preservation stent graft according to the present invention it may be possible to treat the majority of the patients with hostile d istal landing zone and preserve one or both internal iliac arteries.
  • the first leg comprises primary and secondary interior lumen, such as the first leg has a double lumen, such as so as to accommodate, respectively, a leg extension deployed trans-femoral for an external iliac artery and a stent graft extension for an internal iliac artery deployed trans-brachial (such as via the left side of a patient).
  • Aneurysm may be "spanned" where the aorto-iliac preservation stent graft may be oriented within the infrarenal segment (such as fixated or anchored at the infrarenal segment, such as at a caudal end portion of the infrarenal segment) of the aorta and the common iliac artery and a leg extension and a stent graft extension may then be arranged in fluid tight connection with the first leg and second leg and extend into the external and internal iliac arteries, respectively, to maintain pelvic blood flow.
  • This may in turn avoid negative side effects including, but not limited to, erectile dysfunction in men, decreased exercise tolerance, and compromise to pelvic profusion that may result in bowel ischemia and death.
  • a possible advantage of this invention is that it enables avoiding a potential problem with sandwich technique and/or gutters endoleak.
  • Another possible advantage of the present invention may be that at least a tapered portion of the first leg is tapered, which in turn enables that a suitable diameter of the first leg and the second leg at the proximal end where they are connected, respectively, to the first bifurcation opening and the second bifurcation opening, and a suitable (larger) diameter of the second leg at its distal with primary and secondary interior lumen.
  • 'proximal' and 'distal' may be understood directions, which are opposite each other.
  • 'distal' may refer to a cranial direction (towards the head) and 'proximal' may refer to a caudal direction (towards the feet).
  • 'first' and 'second' may refer to respective sides on an axis being orthogonal, or substantially orthogonal, to an axis which is aligned along a proximal-distal direction, such as 'left' and 'right'. It may in particular be understood, for example during use (such as when a stent graft is placed in a patient) 'first' may refer to a side defined as 'ipsilateral' (which may for example correspond to an ipsilateral common iliac artery) and 'second' may refer to a side defined as 'contralateral' (which may for example correspond to a contralateral iliac artery) .
  • 'primary' and 'secondary' may refer to respective sides on an axis being orthogonal, or substantially orthogonal, to an axis which is aligned along a proximal-distal direction . It may in particular be understood, for example during use (such as when a stent graft is placed in a patient) 'primary' or 'tertiary' may refer to a side corresponding to an external iliac artery and 'second' or
  • 'quaternary' may refer to a side corresponding to an internal iliac artery. It is furthermore noted that 'primary' and 'secondary' and 'tertiary' and 'quaternary' are merely used for naming purposes, such as for enabling distinguishing between different entities. The use of primary, secondary, tertiary and quaternary does not imply any sequence. Similarly, it cannot be inferred from any one of 'primary', 'secondary', 'tertiary' and 'quaternary' that others are present or not, e.g ., if a feature is referred to as secondary it is not implied that a primary counterpart is present.
  • 'primary' may be related to the external iliac artery in the ipsilateral side, e.g ., primary interior lumen may be the larger (with respect to the secondary interior lumen) lumen in the first leg in the first/ipsilateral side, and primary leg extension may be the part which goes into the external iliac artery in the first/ipsilateral side.
  • 'secondary' may be related to the internal iliac artery in the ipsilateral side, e .g ., secondary interior lumen may be the smaller (with respect to the primary interior lumen) lumen in the first leg in the first/ipsilateral side, and secondary stent graft extension may be the part which goes into the internal iliac artery in the first/ipsilateral side.
  • tertiary' may be related to the external iliac artery in the contralateral side, e.g ., tertiary interior lumen may be the larger (with respect to the quaternary interior lumen) lumen in the second leg in second/contralateral side, and tertiary leg extension may be the part which goes into the external iliac artery in the contralateral side, e.g ., tertiary interior lumen may be the larger (with respect to the quaternary interior lumen) lumen in the second leg in second/contralateral side, and tertiary leg extension may be the part which goes into the external iliac artery in the
  • 'quaternary' may be related to the internal iliac artery in the contralateral side, e.g ., quaternary interior lumen may be the smaller (with respect to the tertiary interior lumen) lumen in the second leg in the second/contralateral side, and quaternary stent graft extension may be the part which goes into the internal iliac artery in the second/contralateral side.
  • 'Aorto-iliac preservation stent graft' is understood as is common in the art, such as a stent graft suitable for being placed in an aorta of a patient and extending into at least one common iliac artery, such as so as to ensure flow through the aorto-iliac preservation stent graft from a proximal end to a distal end .
  • the aorto- iliac preservation stent graft may in particular be suitable for treatment of aorto- iliac aneurysms, such as for treatment of patients with an aneurysm in the aorta and in one or both common iliac arteries, such as for treatment of patients with an aneurysm extending from an aorta and into one or both common iliac arteries.
  • Said treatment may comprise placing the aorto-iliac preservation stent graft so as to extend from above the aneurysm in the aorta to below the aneurysm in one or both common iliac arteries (optionally via one or more further stent grafts, leg extensions and/or extension legs).
  • blood flow may be secured via the aorto-iliac preservation stent graft or aorto-iliac preservation stent graft assembly, thereby excluding the aneurysmal sac from blood flow and pressure and preventing the walls of the aneurysm from rupturing.
  • aorto-iliac preservation stent graft for treatment of aorto-iliac aneurysms may be understood that the aorto-iliac preservation stent graft is suitable for treatment of aorto-iliac aneurysms, such as capable of, arranged for, configured for and/or adapted for treatment of aorto-iliac aneurysms.
  • Stent graft is employed as is common in the art, and may refer to a tubular, radially expandable device comprising a fluid-tight fabric supported by a stent, and is used to bridge diseased arteries.
  • stent grafts and methods for their deployment and use are known to those of skill in the art.
  • vascular sheaths can be introduced into the patient's arteries, through which items, including but not limited to, guidewires, catheters and, eventually,
  • the stent graft is passed.
  • “Stent” is employed as is common in the art, typically tubular, such as cylindrical, frame and means any device or structure that adds rigidity, expansion force, or support to a prosthesis
  • “stent graft” refers to a prosthesis comprising a stent and a graft material associated therewith that forms a fluid-tight lumen through at least a portion of its length.
  • a “graft” is liner that may be disposed on the stent' s interior, exterior or both.
  • attachment mechanisms are available to join the stent and graft together, including but not limited to, sutures, adhesive bonding, heat welding, and ultrasonic welding .
  • 'main body' may be understood a part of the graft on a proximal side of the bifurcation (which bifurcation may be suitable for placement in connection with an aortic bifurcation).
  • 'end portion' may be understood a finite end portion, such as an end portion having some non-zero length.
  • 'end' may be understood an infinitely thin end, such as an end plane.
  • first leg' may be understood a leg on one side (such as a first side and/or an ipsilateral side) of the aorto-iliac preservation stent graft, which extends from the bifurcation to the distal end of the (first side of the) graft.
  • second leg' may be understood a leg on one side (such as a second side and/or a contralateral side) of the aorto-iliac preservation stent graft, which extends from the bifurcation to the distal end of the (second side of the) graft.
  • first lumen in fluid communication with the main lumen' may be understood that the main lumen and first lumen are in fluid communication via a fluid-tight connection.
  • second lumen in fluid communication with the main lumen' may be understood that the main lumen and second lumen are in fluid communication via a fluid-tight connection.
  • a tapered portion of the first leg is tapered with a cross-sectional area increasing in a direction away from the main body' may be understood that somewhere (on an axis in a direction of flow through the first leg) between the the proximal end of the first leg (where the first leg is connected to the first bifurcation opening) and the distal end of the second leg (such as the tapering being in the beginning, the middle and/or the end), the diameter is (gradually) increasing.
  • first leg can be smaller at a proximal end (where only a limited total diameter to be shared with the second leg is available) and larger, such as 5 % or more larger, such as 10 % or more larger, such as 15 % or more larger, such as 20 % or more larger, such as 25 % or more larger, or such as 1 mm or more larger, such as 2 mm or more larger, such as 3 mm or more larger, such as 4 mm or more larger, at a distal end (where it needs a certain minimum diameter to accommodate leg extensions for an internal iliac artery and an external iliac artery).
  • At least a distal end portion of the first leg comprises (primary and secondary interior lumen)' may be understood that the distal end portion of the first leg defines a coherent, such as non-branched, volume, and inside, such as in the interior of this (double-barrelled) volume, there is placed the primary and secondary interior lumens.
  • the distal end portion of the first leg may from the outside appear as a single tubular graft, but inside there are two interior lumens.
  • a leg extension or stent graft extension may be sealingly connected to the lumen. This may be realized by the lumen having a certain diameter such as 8-14, such as 8- 12 or 12-14, and/or by the respective interior lumen being cylindrical along a distal end portion, which is at least 18 mm, such as at least 20 mm.
  • connection may be understood passive “passive fixation”, which refers to friction interaction between cloths of the grafts, where radial strength of the stent and blood pressure that holds the component stent grafts together at the site of overlap.
  • 'being suitable for entering into a first internal iliac artery' may be understood a relative position with respect to the remainder of the aorto-iliac preservation stent graft and/or a certain diameter, such as 8-12 mm.
  • first leg length being larger than a second leg length, may be that it enables placing the aorto-iliac preservation stent graft in an aorta, deploying it in a direction of a first common iliac artery, whereby the first leg enters into the first common iliac artery, but the second leg stays above the aortic bifurcation, which in turn enables that an extension leg can be placed on the second leg, which extension leg can extend into the second (contralateral) iliac artery.
  • 'length' such as 'leg length' or 'a total length of the aorto-iliac preservation stent graft'
  • length is to be measured along a centre line of the corresponding section, such as along a - possibly non-rectilinear - line through the centre line, such as a line which is at any point parallel with a direction of flow.
  • the section such as the 'first leg'
  • the length follows the curved line defining the centre.
  • the length is longer than a length of a direct line directly from one end to the other.
  • graft material is formed in one piece, such as being unitary, such as not exhibiting any (possibly overlapping) portions where different pieces of graft material are assembled, such as stitched together or glued together.
  • a possible advantage of such monolithic construction may be that it increases strength and/or reduces a risk of endoleaks, thrombosis, and/or flow discontinuities.
  • An advantage of this may be that it ensures that the aorto-iliac preservation stent graft is assembled in advance of being deployed in the patient. This may in turn reduce the necessity of calculations (e.g., for ensuring the correct sizes of stent graft elements for proper positioning with respect to landing zone) before deployment. This may also in turn ensure that the aorto-iliac preservation stent graft is suitable for more patients, such as for a larger range of sizes of patients. This may also in turn render it more appropriate for acute patients, since it is more likely to be suitable for said patient (even without calculations). Another possible advantage is that the absence of connections between separate pieces of graft material ensures that the aorto-iliac preservation stent graft is stronger, and less likely to, e.g., leak.
  • an aorto-iliac preservation stent graft wherein a length of the monolithic unit comprising the main body, the first leg and the second leg is equal to a sum of the length of the main body, the length of the first leg and the length of the second leg .
  • a stent graft which is assembled of several overlapping parts (i.e., not being monolithic)
  • the sum of the lengths of the parts may be longer than the length of the graft.
  • an aorto-iliac preservation stent graft wherein there is no overlap between graft material of any one of the main body, the first leg and the second leg.
  • an aorto-iliac preservation stent graft wherein a length of the monolithic unit comprising the main body, the first leg and the second leg is equal to a sum of the length of the main body and the length of the first leg.
  • an aorto-iliac preservation stent graft wherein there is no overlap between graft material of any one of the main body, the first leg and the second leg.
  • an aorto-iliac preservation stent graft wherein the first leg defines a tubular wall that is contiguous with the primary interior lumen and the secondary interior lumen such that any fluid entering the first leg from the main body must exit through the primary interior lumen and/or the secondary interior lumen.
  • the walls of the aorto-iliac preservation stent graft provide a complete circumferential seal and there may be no external compromise or compression of the lumen walls, which prevents blood flow through the lumens from being affected .
  • Previous "sandwich,” “snorkel” and “chimney” devices were constructed by simultaneously placing two or more single lumen stent grafts side by side within the aorta. These previous stent grafts defined open spaces where the walls of the lumens did not completely abut each other or the aortic walls and allowed blood to flow through the open spaces and into the aneurysm. These previous devices were further subject to collapse or compression due to external pressures.
  • the aorto-iliac preservation stent graft may be formed so that the first leg defines a tubular wall that is contiguous with the primary interior lumen and the secondary interior lumen as described above using any suitable process.
  • the aorto-iliac preservation stent graft may be woven, for example using a process as described in the patent application US 20130204354 Al, which is hereby incorporated by reference in entirety.
  • the primary and secondary interior lumen may for example be realized by twice inverting an external side branch, for example using a process as described in the patent application EP 2 875 796 A2, which in hereby incorporated by reference in entirety, such as in particular as described in paragraph [0013] of EP 2 875 796 A2, which paragraph is hereby included by reference.
  • the monolithic graft of the aorto-iliac preservation stent graft can be manufactured with a distal end portion
  • the first leg (comprising the primary and secondary interior lumen) of the first leg being double-barrelled, such as comprising a dual lumen being monolithic, such as unitary, such as one piece, with respect to the remainder of the aorto-iliac preservation stent graft.
  • An advantage of this may be that it enables connecting a leg extension and/or a stent graft extension to the primary interior lumen and/or secondary interior lumen in a manner avoiding open spaces there between where the walls of the lumens (or the leg extension and stent graft) do not completely abut each other, which would allow blood to flow through the open spaces and into the aneurysm.
  • an aorto-iliac preservation stent graft wherein the main body defines a tubular wall that is contiguous with the first leg and the second leg such that any fluid entering the main body from the proximal end must exit through the first leg and/or the second leg.
  • an aorto-iliac preservation stent graft wherein the first lumen is arranged so that in a cross-sectional view, such as in a plane being orthogonal to a flow-direction, an outer boundary of the first lumen encompasses each of the primary interior lumen and the secondary interior lumen and forms a coherent area.
  • An advantage of this may be that it mitigates problems with branching, such as problems with rendering the aorto-iliac preservation stent graft compact enough for sheath delivery and/or problems with suboptimal flow-conditions at or close to the branching.
  • a length of the main body (such as a length as measured from a proximal end of the main body to the bifurcation) is within 70-100 mm, such as within 75-100 mm, such as within 80-100 mm, and/or
  • a length of the tapering portion of the first leg is within 10-30 mm, such as 20 mm, and/or
  • a length of a portion of the first leg from the first bifurcation opening to the beginning of the primary interior lumen and the secondary interior lumen is within 20-40 mm, such as 30 mm,
  • lumen is within 20-40 mm, such as 30 mm,
  • a diameter of the first bifurcation opening and/or a diameter of the first leg at the narrow end of the tapering portion, such as at the first bifurcation opening, is within 11-13 mm
  • a diameter of the second bifurcation opening and/or a diameter of the second leg, such as a diameter of the second leg at the second bifurcation opening, is within 11-13 mm
  • a diameter of the primary interior lumen such as a diameter of the
  • a diameter of the secondary interior lumen is within 8-12 mm,
  • a diameter of the first leg at the wide end of the tapering portion and/or a diameter of the opening of the first leg at the end opposite the first bifurcation opening is within 20-26 mm
  • a total length (such as a length from a proximal end of the main body to the distal end of the first leg) of the aorto-iliac preservation stent graft (100) is within 140-160 mm, such as within 140-150 mm
  • a distal end portion of the first leg is cylindrical, such as a length of said cylindrical distal end portion of the first leg is at least 20 mm.
  • a diameter of the primary interior lumen may be larger, such as 5 % or more larger, such as 10 % or more larger, such as 15 % or more larger, such as 20 % or more larger, such as 25 % or more larger, such as 50 % or more larger, or such as 1 mm or more larger, such as 2 mm or more larger, such as 3 mm or more larger, such as 4 mm or more larger, such as 5 mm or more larger, than a diameter of the secondary interior lumen. This may be advantageous for hemodynamics.
  • An advantage of having a total length (such as a length from a proximal end of the main body to the distal end of the first leg) of the aorto-iliac preservation stent graft (100) being within 140-160 mm, such as within 140-150 mm, may be that it enables treating a very large group of patients, such as 90 % or more.
  • a length (128) of the main body (104) is within 70-100 mm, such as within 80-100 mm.
  • a diameter of the main body is 22-36 mm, such as 23-36 mm.
  • a diameter of the main body is 22-26 mm.
  • an aorto-iliac preservation stent graft wherein : - A diameter of the first bifurcation opening and/or a diameter of the first leg at the narrow end of the tapering portion, such as at the first bifurcation opening, is within 11-13 mm,
  • second leg such as a diameter of the second leg at the second bifurcation opening, is within 11-13 mm
  • a diameter (142) of the primary interior lumen is within 12-14 mm
  • a diameter (144) of the secondary interior lumen is within 8-12 mm.
  • a total length of the aorto-iliac preservation stent graft (100) is within 140-160 mm, such as within 140-150 mm.
  • any one or both of the primary and secondary interior lumen has a constant diameter along a distal end portion of the first lumen, which distal end portion with constant diameter is at least 18 mm, such as at least 20 mm.
  • the aorto-iliac preservation stent graft of the present invention may contain any further suitable components, including but not limited to radiopaque markers to aid in visualization and to facilitate accurate placement of the aorto-iliac preservation stent graft stent graft.
  • an aorto-iliac preservation stent graft further comprising one or more radio-opaque markers at the first leg, such as
  • Radio-opaque markers may comprise, such as consist of, platinum, platinum- iridium, tantalum and/or gold.
  • stent material being any one of:
  • Nitinol where nitinol is understood to be an alloy comprising nickel and titanium, such as comprising 49.5-57.5 wt% (weight percent) nickel, such as consisting of nickel and titanium and comprising 49.5-57.5 wt% nickel,
  • a cobalt-nickel-chromium-iron alloy such as a having a
  • composition in wt % (weight percent), of 39.0 ⁇ 41.0 Co (cobalt), 19.0 ⁇ 21.0 Cr, 14.0 ⁇ 16.0 Ni, 6.0 ⁇ 8.0 Mo
  • graft material being any one of:
  • an aorto-iliac preservation stent graft wherein an axis through the primary interior lumen, such as said axis intersecting a centre of the primary interior lumen at a distal end of the primary interior lumen, is substantially parallel, such as an angular difference being within 0-45 degrees, such as within 0-30 degrees, such as within 0-15 degrees, such as within 0-10 degrees, such as within 0-5 degrees, such as parallel, with an axis through the secondary interior lumen such, as said axis intersecting a centre of the secondary interior lumen at a distal end of the secondary interior lumen.
  • An advantage of this may be that a flow direction can be substantially constant throughout the graft, which may be an advantage since the graft then does not have to apply forces to redirect the flow.
  • a flow direction can be substantially constant throughout the graft, which may be an advantage since the graft then does not have to apply forces to redirect the flow.
  • 'an axis through' a lumen may be understood that the axis is parallel with a direction of flow through the centre of the lumen.
  • a direction of flow through the centre of the first bifurcation opening is substantially parallel, such as angular difference being within 0-45 degrees, such as within 0-30 degrees, such as within 0-15 degrees, such as within 0-10 degrees, such as within 0-5 degrees, such as parallel, with a direction of flow through the second bifurcation opening.
  • the first leg and the second leg are substantially axially aligned, such as substantially parallel, such as angular difference being within 0-45 degrees, such as within 0-30 degrees, such as within 0-15 degrees, such as within 0-10 degrees, such as within 0-5 degrees, such as parallel, with respect to each other.
  • the main body being in an aorta of the patient, such as in the infrarenal segment,
  • first leg extending down a first common iliac artery, such as an ipsilateral common iliac artery,
  • the second leg being directed towards a second common iliac artery, such as a contralateral common iliac artery.
  • an aorto-iliac preservation stent graft assembly comprising an aorto-iliac preservation stent graft according to the first aspect, and said aorto-iliac preservation stent graft assembly further comprising :
  • An extension leg such as a contralateral extension leg, suitable for extending from the second leg, wherein the extension leg comprises an extension leg lumen with a proximal end suitable for being in fluid communication with a lumen of the second leg, such as upon being sealingly engaged with the second leg,
  • extension leg wherein at least a distal end portion, such as the distal end portion having a cross-sectional area which increases or decreases in a direction away from the main body, of the extension leg is divided into,
  • An advantage of this may be that in a case where we will preserve both internal iliac arteries, then it is possible to use the aorto-iliac preservation stent graft with the first leg down the first common iliac artery and on the second (contralateral) side attach the extension leg and place it in the second (contralateral) common iliac artery.
  • Four different leg extensions can now be attached to the internal an external iliac arteries on both sides.
  • the extension leg may have a length within 5-15 cm.
  • an aorto-iliac preservation stent graft assembly wherein the extension leg is connected to the second leg, such as sealingly engaged with the second leg.
  • an aorto-iliac preservation stent graft assembly further comprising :
  • an adapter for use in an aorta, such as for allowing preservation of the renal arteries, wherein the adapter may allow fluid-tight connection between a single lumen, such as a descending aorta and renal arteries and an abdominal aorta, where the adapter comprises
  • a further lumen for the aorta where the further lumen has a larger diameter than each of the two internal lumen, and o an outer enclosing stent graft enclosing the two internal lumen and the further lumen,
  • each of the two internal lumina ends as each end as fenestration in the outer enclosing stent graft.
  • extension leg is arranged so that upon being sealingly engaged with the second leg, the aorto-iliac preservation graft assembly is substantially symmetrical, such as symmetrical. This may be realized by having the extension leg being substantially similar to the portion of the first leg which extends distally with respect to an end of the second leg.
  • aorto-iliac preservation stent graft comprising:
  • first leg extending down a first common iliac artery, such as an ipsilateral common iliac artery,
  • the second leg being directed towards a second common iliac artery, such as a contralateral common iliac artery.
  • An advantage of this may be that it enables attaching (such as anchoring), the aorto-iliac preservation stent graft, such as proximal end portion of the main body, to an infrarenal segment and spanning an aorto-iliac aneurysm with the aorto-iliac preservation stent graft and one or more leg extensions, which may be attached (such as anchored), respectively to internal and external iliac arteries.
  • anchoring refers to placing, such as securing or fixating, a stent graft in direct contact with a non-diseased portion of the arterial vessel wall.
  • An advantage of this may be that it may enable treating patients with bilateral aorto-iliac aneurysms.
  • a stent graft adapter can for example serve as adapter between different types of lumen, for example from a single lumen to a dual lumen.
  • the adapter may comprise one or more input openings, such as openings for receiving a blood flow, and one or more output openings, such as openings for allowing a blood flow to exit the adapter.
  • Each of the input- end output openings may or may not be arranged for connection to another stent graft.
  • the adapter may define a wall that is contiguous such that any fluid entering the one or more input openings must exit through the one or more output openings.
  • An advantage of this may be that of preventing extraneous blood flow into, e.g., an aneurysm.
  • the walls of the adapter may provide a complete circumferential seal.
  • the stent graft adapter can be widely used to treat the aneurysms and atherosclerotic aorta-iliac diseases.
  • the stent and the graft material can be provided as described elsewhere in the present application.
  • the stent graft adapter can be made of Polytetrafluoroethylene (PTFE) stent graft material and with nitinol wire.
  • PTFE Polytetrafluoroethylene
  • a stent graft adapter for use in the common iliac artery to allow preservation of the internal iliac artery in the treatment of aorta-iliac aneurysms, said adapter comprises two lumen extending all the way through the structure, which is enclosed by an outer stent graft.
  • the adapter is suitable for treatment of aorta- iliac aneurysms and/or suitable for being placed in a common iliac artery.
  • the stent graft adapter according to this first specific embodiment may hereafter be referred to as iliac adapter.
  • the iliac adapter comprises a first and a second inlet opening, which are respectively connected to a first and second outlet opening via, respectively a first lumen and a second lumen.
  • a direction, such as a flow- direction, from the first input opening to the first output opening is parallel with a direction, such as a flow-direction, from the second output opening to the second output opening.
  • the first lumen and the second lumen may be arranged so that in a cross-sectional view, such as in a plane being orthogonal to a flow-direction, an outer boundary of the first lumen encompasses each of the first lumen and the second lumen and forms a coherent area
  • the iliac adapter may be compatible with all available devices on the market.
  • Figure 10 demonstrates the treatment principle.
  • the stent graft adapter can be used for this indication as a part of primary intervention or as secondary intervention in an already placed aorta abdominal stent graft.
  • the iliac adapter may furthermore comprise one or more markers for aiding the
  • connection such as one or more radiopaque markers, such as one or more radiopaque markers which may aid in visualization and to facilitate accurate placement and/or enabling determining a position of the adapter in a patient, such as said position relative to a position of an associated stent graft with which the adapter must be connected.
  • a one-lumen through the femoral access can deploy the stent graft extension into external iliac artery and through the another lumen via left brachial assess, bridge stent graft can be deployed in internal iliac artery.
  • Stent graft adapter can be used on one or both side.
  • the iliac adapter may have a length (along a direction, such as a flow-direction, from the first input opening to the first output opening and/or along a direction, such as a flow- direction, from the second output opening to the second output opening) which is within 16-24 mm, such as 18-22 mm, such as 20 mm.
  • a diameter of any one or more of the first inlet opening and/or the first output opening may be within 12- 14 mm.
  • a diameter of any one or more of the second inlet opening and/or the second output opening may be within 8-12 mm.
  • a one-lumen extension stent graft can be supplied and fluidically connected to the first output opening through femoral access and be deployed into an external iliac artery and another one-lumen extension stent graft can be supplied and fluidically connected to the second output opening via left brachial assess and can be deployed in an internal iliac artery.
  • the iliac adapter can be used on one or both side, such as in one or both common iliac arteries.
  • a stent graft adapter for use in the aorta, such as below the renal arteries and above the iliac bifurcation, wherein said adapter said adapter comprises two lumen extending at least some, such as all, the way through the structure, which is enclosed by an outer stent graft, and wherein the diameter at at least one end, such as a one-lumen end is 14-25 mm.
  • the adapter may allow fluid connection between a single lumen aorta/stent graft in the aorta and two separate single- lumen stent grafts extending, respectively, into the left common iliac artery and the right common iliac artery (see FIGS. 15-16).
  • the second embodiment may be suitable for use in atherosclerotic aorta-iliac diseases, such as with very calcified aorta-iliac segment and /or with significant amount of the thrombus, further in prospective studies some of the aorto-iliac lesion could be treated preferably with use of a covered stent graft system.
  • the stent graft adapter according to this first specific embodiment may hereafter be referred to as aorta adapter.
  • the aorta adapter may allow smooth transition to an iliac limb and/or avoid possible problem with "kissing" placed stent graft or "kissing" placed bare metal stent. It may provide better stability of the stent inside the inner lumen compared with a "simple" deployment inside a bigger aorta stent graft, such as in a Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) intervention.
  • CERAB Covered Endovascular Reconstruction of Aortic Bifurcation
  • the entire stent graft adapter is divided in two lumen.
  • the diameter of the adapter is from 14-22 mm.
  • a first part of the aorta adapter can have a length from 2-5 cm and only one lumen. Distally in a 2 cm length, the adapter will be designed to have two lumen. The proximal part with one lumen can have a variable diameter from 14-25 mm.
  • an adapter for use in a thoraic aorta, such as for allowing preservation of the left subclavian artery.
  • the adapter may allow fluid connection between a single lumen aorta/stent graft in the ascending aorta and the left subclavian artery,
  • the stent graft adapter may hereafter be referred to as thoraic arch adapter.
  • the thoracic adapter will have one smaller inner lumen/tunnel for the left subclavian artery which end with a fenestration.
  • the graft adapter will have possibility for partial deployment and after the bridging stent graft is deployed through the left brachial access full deployment of the adapter is performed.
  • FIG 17 an example of the present third embodiment is illustrated .
  • an adapter for use in an aorta (see figure 18), such as for allowing preservation of the renal arteries
  • the adapter according to this fourth embodiment allows fluid connection between a single lumen, such as a suprarenal aorta (and optionally a stent graft in the descending aorta) and renal arteries and an abdominal aorta
  • the adapter comprises two internal lumina, and a further and bigger (such as bigger diameter with respect to a diameter of each of the two internal lumina) lumen for the aorta.
  • the diameter of the adapter can be from 28- 36 mm and with 4-6 cm length.
  • the constrain guidwire will allow the partial adapter opening and allow changing of the position before definitive deployment.
  • the two internal (renal inner lumen/tunnel) will each end as fenestration in the adapter to allow catheterisation of the renal arteries.
  • the fourth embodiment may present a stent graft adapter for the treatment of abdominal aortic aneurysm, e.g., instead of using Chimney stent graft, where the adapter has a special design with two small 6-8 mm internal lumen for the renal artery and a big lumen for the aorta.
  • the diameter of the adapter can be from 28-36 mm and with 4-6 cm length.
  • the renal inner lumen/tunnel will end as fenestration to allow
  • the first, second and third aspect of the present invention may each be combined with any of the other aspects.
  • FIG. 1 shows an aorto-iliac preservation stent graft
  • FIG. 2 shows an aorto-iliac preservation stent graft assembly
  • FIG. 3 shows an aorto-iliac preservation stent graft assembly
  • FIG. 4 shows an aorto-iliac preservation stent graft assembly as depicted in FIG. 2 placed in a patient.
  • FIG. 5 shows an aorto-iliac preservation stent graft assembly as depicted in FIG. 3 placed in a patient.
  • FIG. 6 shows a method for placement of an aorto-iliac preservation stent graft.
  • FIG. 7 shows a side view of a stent graft corresponding to the main body portion.
  • FIG. 8 shows en end view of the stent graft also shown in FIG. 7.
  • FIG. 9 shows en end view of the stent graft also shown in FIGS. 7-8.
  • FIG. 10 shows an iliac adapter placed in a patient.
  • FIG. 11 shows an end view of an iliac adapter.
  • FIG. 12 shows an (opposite, with respect to FIG. 11) end view of an iliac adapter.
  • FIG. 13 shows a side view of an iliac adapter.
  • FIG. 14 shows a perspective view of an iliac adapter.
  • FIG. 15 shows an aorta adapter placed in a patient.
  • FIG. 16 shows example dimensions of an aorta adapter.
  • FIG. 17 shows a thoracic arch adapter placed in a patient.
  • FIG. 18 shows a example of the 4 th embodiment according to the adapter aspect. DETAILED DESCRIPTION OF AN EMBODIMENT
  • FIG . 1 shows an aorto-iliac preservation stent graft 100 for treatment of aorto- iliac aneurysms, said aorto-iliac preservation stent g raft comprising :
  • proximal end portion 106 with a proximal opening 108 at a proximal end
  • a first leg 101 such as an ipsilateral leg, extending distally from the first bifurcation opening 111, such as extend ing in a direction away from the main body,
  • first leg 101 comprises a first lumen in fluid communication with the main lumen
  • a second leg 102 such as a contralateral leg, extend ing from the second bifurcation opening 112 in a direction away from the main body 104,
  • first leg length 124 is larger than a second leg length 126, such as the first leg length is larger than the second leg length and a difference between the first leg length and the second leg length is 15 mm or more, such as within 15-20 mm,
  • graft material of the main body 104, the first leg 101 and the second leg 102 form a monolithic unit of biocompatible graft material.
  • the dimensions of the aorto-iliac preservation stent graft 100 are given as:
  • a length 128 of the main body 104 is within 70-100 mm, such as within 75- 100 mm, such as within 80-100 mm, and/or
  • a length 130 of the tapering portion 132 of the first leg 101 is within 10-30 mm, such as 20 mm, and/or
  • a length 134 of a portion of the first leg from the first bifurcation opening 111 to the beginning of the primary interior lumen and the secondary interior lumen is within 20-40 mm, such as 30 mm,
  • a length 136 of the primary interior lumen and/or the secondary interior lumen is within 20-40 mm, such as 30 mm,
  • a diameter 138 of the first bifurcation opening and/or a diameter of the first leg at the narrow end of the tapering portion, such as at the first bifurcation opening, is within 11-13 mm
  • a diameter 140 of the second bifurcation opening and/or a diameter of the second leg, such as a diameter of the second leg at the second bifurcation opening, is within 11-13 mm
  • a diameter 142 of the primary interior lumen is within 12-14 mm, such as 14 mm,
  • a diameter 144 of the secondary interior lumen such as a diameter of the secondary interior lumen at a distal end, a is within 8-12 mm,
  • a diameter of the opening of the first leg at the end opposite the first bifurcation opening is within 20-26 mm
  • a distal end portion of the first leg is cylindrical, such as a length of said cylindrical distal end portion of the first leg is at least 20 mm.
  • FIG. 2 shows an aorto-iliac preservation stent graft assembly 250 comprising an aorto-iliac preservation stent graft 100 according to the first aspect, and said aorto-iliac preservation stent graft assembly further comprising a leg extension 252, suitable for extending from the second leg 102 suitable for extending into a second (contralateral) common iliac artery of a patient.
  • the figure furthermore shows a leg extension 218 being suitable for entering into a first external iliac artery.
  • the figure furthermore shows a stent graft extension 222 being suitable for entering into a first internal iliac artery.
  • FIG. 3 shows an aorto-iliac preservation stent graft assembly 350 comprising an aorto-iliac preservation stent graft 100 according to the first aspect, and said aorto-iliac preservation stent graft assembly further comprising :
  • extension leg 352 suitable for extending from the second leg (102), wherein the extension leg comprises an extension leg lumen and wherein at least a distal end portion of the extension leg is divided into,
  • a cross-sectional area of at least a tapered portion of the extension leg increases in a direction from the proximal end to the distal end.
  • FIG. 4 shows an aorto-iliac preservation stent graft assembly 250 as depicted in FIG. 2 (albeit being shown in FIG. 4 in assembled form) placed in a patient.
  • FIG. 5 shows an aorto-iliac preservation stent graft assembly 350 as depicted in FIG. 3 (albeit being shown in FIG. 5 in assembled form and further comprising a tertiary leg extension and a quaternary stent graft extension) placed in a patient.
  • FIG. 6 shows A method 670 for placement of an aorto-iliac preservation stent graft, the method comprising : - introducing 672 a guidewire into an aorta via trans-femoral arterial access;
  • the second leg being directed towards a second common iliac artery.
  • the method furthermore comprises:
  • FIG. 7 shows a side view of a stent graft corresponding to the main body portion 25 704, where the figure also shows a portion corresponding to the proximal end portion 706, the distal end portion 710 and furthermore the first bifurcation opening 711 and the second bifurcation opening 712.
  • FIG. 8 shows en end view of the stent graft also shown in FIG. 7 corresponding to 30 the main body 704 portion, wherein the end view is obtained at the proximal end portion 706 looking towards the proximal end portion (and at the distant end from the observer, the distal end portion) where the figure also shows the proximal opening 108.
  • FIG. 9 shows en end view of the stent graft also shown in FIGS. 7-8
  • FIG. 10 shows an iliac adapter 1054 placed in a patient.
  • the figure shows an bifurcated stent graft 1056, such as an AAA bifurcated stent graft (e.g., a Zenith AAA stent graft; Cook Incorporated, Bloomington, Indiana) placed in the aorta and with the legs extending towards the common iliac arteries.
  • the figure furthermore shows the iliac adapter 1054 placed in one leg of the bifurcated stent graft 1056, and furthermore a leg extension 1018 entering into an external iliac artery and a stent graft extension 1022 entering into an internal iliac artery.
  • the iliac adapter allows placement of the leg extension 1018 into the external iliac artery and with left percutaneous access placement of the stent graft extension 1022 in an internal iliac artery.
  • the iliac adapter 1054 could be placed in the iliac artery and being fixed to the vessel wall, such as without the bifurcated stent graft.
  • FIG. 11 shows an end view of the iliac adapter, such as the picture being obtained from and towards an end of the iliac adapter suitable for being placed facing the aorta.
  • FIG. 12 shows an (opposite, with respect to FIG. 11) end view of the iliac adapter, such as the picture being obtained from and towards an end of the iliac adapter suitable for being placed facing the bifurcation of the iliac artery into the internal/external iliac arteries.
  • FIG. 13 shows a side view of the iliac adapter.
  • FIG. 14 shows a perspective view of the iliac adapter, such as the picture being obtained from and towards an end of the iliac adapter suitable for being placed facing the aorta, but where the camera is placed somewhat off the axis of the lumina.
  • FIG. 15 shows an aorta adapter 1504 placed in a patient. There may be stenosis in abdominal aorta plus stenosis of both common iliac arteries. The figure furthermore shows a first extension leg 1501 being fluidically connected to the aorta adapter and entering into a common iliac artery and a second extension leg 1502 being fluidically connected to the aorta adapter and entering into the other common iliac artery.
  • FIG. 16 shows example dimensions of an aorta adapter 1604. It comprises a portion with one common lumina, which is 2-5 cm, and another portion with two lumina, which is 2 cm.
  • FIG. 17 shows a thoracic arch adapter 1760 placed in a patient.
  • the thoracic arch adapter 1760 is shown fluidically connected to a thoracic stent graft 1762.
  • FIG. 18 shows a example of the 4 th embodiment according to the adapter aspect. More particularly, the figure shows an adapter for use in an aorta, such as for allowing preservation of the renal arteries, wherein the adapter may allow fluid- tight connection between a single lumen, such as a descending aorta and renal arteries and an abdominal aorta, where the adapter comprises
  • each of the two internal lumina ends as each end as fenestration, such as a first fenestration 1868 and a second fenestration 1869, in the outer enclosing stent graft.
  • an aorto-iliac preservation stent graft (100) for treatment of aorto-iliac aneurysms said aorto-iliac preservation stent graft comprising a main body (104) comprising a bifurcation, and a first leg (101) with with a cross-sectional area increasing in a direction away from the main body (104), and wherein at least a distal end portion of the first leg comprises a primary interior lumen (116) suitable for connection to a leg extension (218) and a secondary interior lumen (120) suitable for connection to a stent graft extension (222), said aorto-iliac preservation stent graft (100) further comprising a second leg (102) wherein a first leg length (124) is larger than a second leg length (126), and wherein graft material of the main body (104), the first leg (101) and the second leg (102) form a monolithic unit of biocompatible graft material.

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  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
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  • Heart & Thoracic Surgery (AREA)
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Abstract

L'invention concerne un greffon de stent de préservation aorto-iliaque (100) pour le traitement d'anévrismes aorto-iliaques, ledit greffon de stent de préservation aorto-iliaque comprenant un corps principal (104) comprenant une bifurcation, et une première patte (101) à une aire de section transversale augmentant dans une direction s'éloignant du corps principal (104), et au moins une partie d'extrémité distale de la première patte comprenant une lumière intérieure primaire (116) approprié pour une connexion à une extension de patte (218) et une lumière intérieure secondaire (120) appropriée pour une connexion à une extension de greffon de stent (222), ledit greffon de stent de préservation aorto-iliaque (100) comprenant encore une seconde patte (102), une longueur de première patte (124) étant supérieure à une longueur de seconde patte (126), et le matériau de greffon du corps principal (104), la première patte (101) et la seconde patte (102) formant une unité monolithique de matériau de greffon biocompatible.
PCT/EP2018/051342 2017-01-20 2018-01-19 Greffon de stent de préservation aorto-iliaque monolithique WO2018134368A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008021556A1 (fr) * 2006-08-18 2008-02-21 William A. Cook Australia Pty. Ltd. Extension de greffon d'endoprothèse
US20130204354A1 (en) 2007-06-27 2013-08-08 Aga Medical Corporation Branched stent/graft and method of fabrication
WO2013155306A1 (fr) * 2012-04-12 2013-10-17 Kelly Patrick W Débranchement et membre d'endoprothèse, et procédés d'utilisation
EP2837362A1 (fr) * 2013-08-15 2015-02-18 Cook Medical Technologies LLC Ensemble pour le traitement de vaisseaux ramifiés
EP2875796A2 (fr) 2013-08-23 2015-05-27 Cook Medical Technologies LLC Ensemble stent-greffe pour traiter un vaisseau ramifié

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008021556A1 (fr) * 2006-08-18 2008-02-21 William A. Cook Australia Pty. Ltd. Extension de greffon d'endoprothèse
US20130204354A1 (en) 2007-06-27 2013-08-08 Aga Medical Corporation Branched stent/graft and method of fabrication
WO2013155306A1 (fr) * 2012-04-12 2013-10-17 Kelly Patrick W Débranchement et membre d'endoprothèse, et procédés d'utilisation
EP2837362A1 (fr) * 2013-08-15 2015-02-18 Cook Medical Technologies LLC Ensemble pour le traitement de vaisseaux ramifiés
EP2875796A2 (fr) 2013-08-23 2015-05-27 Cook Medical Technologies LLC Ensemble stent-greffe pour traiter un vaisseau ramifié

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