WO2016160540A1 - Endogreffons améliorés pour la réparation endovasculaire d'anévrismes aortiques abdominaux - Google Patents

Endogreffons améliorés pour la réparation endovasculaire d'anévrismes aortiques abdominaux Download PDF

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Publication number
WO2016160540A1
WO2016160540A1 PCT/US2016/024136 US2016024136W WO2016160540A1 WO 2016160540 A1 WO2016160540 A1 WO 2016160540A1 US 2016024136 W US2016024136 W US 2016024136W WO 2016160540 A1 WO2016160540 A1 WO 2016160540A1
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Prior art keywords
distal
endograft
graft
stented
limb
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PCT/US2016/024136
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English (en)
Inventor
Hugh TROUT
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Eva Corporation
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Publication of WO2016160540A1 publication Critical patent/WO2016160540A1/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
    • 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
    • A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
    • 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
    • A61F2250/0036—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 thickness
    • 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
    • A61F2250/0037—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 height or in length
    • 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
    • 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
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
    • A61F2250/0063—Nested prosthetic parts
    • 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
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the present subject matter relates generally improved endograft designs and related systems and methods for the endovascular repair of abdominal aortic aneurysms.
  • An aneurysm is a ballooning of the wall of an artery resulting from the weakening of the artery due to disease or other conditions. Left untreated, the aneurysm will frequently rupture, resulting in loss of blood through the rupture and death.
  • Aortic aneurysms are the most common form of arterial aneurysm and are life threatening.
  • the aorta is the main artery which supplies blood to the circulatory system.
  • the aorta arises from the left ventricle of the heart, passes upward and bends over behind the heart, and passes down through the thorax and abdomen.
  • the abdominal aorta supplies two side vessels to the kidneys, the renal arteries.
  • the abdominal aorta continues to about the level of the fourth lumbar vertebrae (or the navel), where it divides into the iliac arteries.
  • the iliac arteries supply blood to the lower extremities and the perineal region.
  • an aortic aneurysm it is common for an aortic aneurysm to occur in the portion of the abdominal aorta between the renal arteries and the iliac arteries. This portion of the abdominal aorta is particularly susceptible to weakening, resulting in an aortic aneurysm. Such an aneurysm is often located near the iliac arteries. An aortic aneurysm larger than about 5 cm in diameter in this section of the aorta is ominous. Left untreated, the aneurysm may rupture, resulting in rapid, and usually fatal, hemorrhaging. Typically, a surgical procedure is not performed on
  • abdominal aortic aneurysms smaller than 5 centimeters as no statistical benefit exists to do so.
  • Aneurysms in the abdominal aorta are associated with a particularly high mortality rate; accordingly, current medical standards call for urgent operative repair. Abdominal surgery, however, results in substantial stress to the body. Although the mortality rate for an aortic aneurysm is extremely high, there is also considerable mortality and morbidity associated with open surgical intervention to repair an aortic aneurysm. This intervention involves penetrating the abdominal wall to the location of the aneurysm to reinforce or replace the diseased section of the abdominal wall (i.e., abdominal aorta). A prosthetic device, typically a synthetic tube graft, is used for this purpose. The graft serves to exclude the aneurysm from the circulatory system, thus relieving pressure and stress on the weakened section of the aorta at the aneurysm.
  • a prosthetic device typically a synthetic tube graft
  • endovascular repair methods have been developed that utilize a fully stented or fully supported endograft.
  • the endograft is inserted through the external iliac artery and into the right and/or left common iliac artery.
  • the proximal portion of the fully supported endograft is attached to the un-dilated portion of the aorta (e.g., often referred to as the aortic neck).
  • the distal portion(s) of the fully supported endograft are attached to the right and left common iliac arteries such that the endograft bridges the aneurysm.
  • fully supported endografts provide a means for treatment of abdominal aortic aneurysms
  • endografts often lead to complications in the long term.
  • fully supported endografts exhibit significant columnar rigidity. While such rigidity may allow for a reduction of the migration of the endograft, the rigidity also prevents the endograft from adapting to changes in the aneurysm conformation, which, over time, can lead to failure of the endograft.
  • fully supported endografts are often quite expensive to manufacture.
  • an endograft for the endovascular repair of an abdominal aorta having an aortic aneurysm and an aortic neck.
  • the endograft may generally include a moderately supported graft body extending lengthwise between a proximal end and a distal end.
  • the graft body may include a proximal tube portion and first and second distal limbs.
  • the proximal tube portion may extend lengthwise between the proximal end of the graft body and the first and second distal limbs.
  • the first and second distal limbs may extend lengthwise between the proximal tube portion and the distal end of the graft body.
  • the proximal tube portion may include a stented section having a stent configured to provide structural support to the proximal tube portion.
  • each of the first and second distal limbs may correspond to non-stented portions of the graft body.
  • proximal tube portion may be configured to be secured to the aortic neck and the distal end of the graft body may be configured to be positioned within the aortic aneurysm.
  • the endograft may include first and second stented grafts.
  • the first stented graft may include a proximal portion configured to be inserted within the first distal limb and a distal portion configured to be received within a first common iliac artery of the abdominal aorta.
  • the second stented graft may include a proximal portion configured to be inserted within the second distal limb and a distal portion configured to be received within a second common iliac artery of the abdominal aorta.
  • the endograft may also include first and second buffer sleeves.
  • the first buffer sleeve may be configured to be received within the first distal limb such that the first buffer sleeve is positioned between the proximal portion of the first stented graft and the first distal limb.
  • the second buffer sleeve may be configured to be received within the second distal limb such that the second buffer sleeve is positioned between the proximal portion of the second stented graft and the second distal limb.
  • the first and second buffer sleeves may be non-stented or stented.
  • each of the first and second distal limbs may define a non-cylindrical shape along at least a portion of its length.
  • a length of the first distal limb may differ from a length of the second distal limb.
  • each of the first and second distal limbs may include a first lengthwise limb section configured to extend within the aortic aneurysm and a second lengthwise limb section configured to extend within a common iliac artery of the aorta.
  • the endograft may include first and second stented tube inserts configured to be inserted within the second lengthwise limb sections of the first and second distal limbs.
  • a portion of each of the first and second distal limbs may define a material thickness that is greater than a material thickness of another portion of each of the first and second distal limbs
  • the endograft may also include a non-structural location identifier incorporated within or coupled to at least one of the first distal limb or the second distal limb.
  • the non-structural location identifier may correspond to a radiopaque marker or a radiopaque wire.
  • the graft body may be formed from a graft material, wherein each of the first and second distal limbs is formed entirely from the graft material.
  • the graft body may be formed from a graft material having an outer later and an inner layer, with the stent being positioned between the outer and inner layers of the graft material.
  • the stented section of the proximal tube portion may be configured to be positioned entirely within the aortic neck.
  • FIG. 1 illustrates a schematic view of an abdominal aorta and its major branches
  • FIG. 2 illustrates a schematic view of the abdominal aorta shown in FIG. 1 having an infrarenal abdominal aortic aneurysm
  • FIG. 3 illustrates a schematic view of one embodiment of a moderately supported graft body that may be used to form all or part of an endograft for the endovascular repair of abdominal aortic aneurysms in accordance with aspects of the present subject matter;
  • FIG. 4 illustrates a cross-sectional view of a portion of the moderately supported graft body shown in FIG. 3 taken about line 4-4;
  • FIG. 5 illustrates the moderately supported graft body shown in FIG. 3 installed within the aorta shown in FIG. 2 relative to the infrarenal abdominal aortic aneurysm in accordance with aspects of the present subject matter;
  • FIG. 6 illustrates a schematic view of one embodiment of a three- piece endograft partially installed within the aorta shown in FIG. 2 relative to the infrarenal abdominal aortic aneurysm in accordance with aspects of the present subject matter; , particularly illustrating the endograft including the moderately supported graft body shown in FIG. 3 and first and second stented grafts configured to be coupled between the graft body and the common iliac arteries of the aorta;
  • FIG. 7 illustrates another schematic view of the endograft shown in FIG. 6, particularly illustrating both stented grafts being installed relative to the graft body;
  • FIG. 8 illustrates a variation of the embodiment of the three- piece endograft shown in FIG. 6 in accordance with aspects of the present subject matter, particularly illustrating the moderately supported graft body including modified distal limbs;
  • FIG. 9 illustrates a schematic view of one embodiment of a five- piece endograft partially installed within the aorta shown in FIG. 2 relative to the infrarenal abdominal aortic aneurysm in accordance with aspects of the present subject matter, particularly illustrating the endograft including the moderately supported graft body shown in FIG. 3, first and second buffer sleeves configured to be received within distal limbs of the graft body, and first and second stented grafts configured to be coupled between the distal limbs and the common iliac arteries of the aorta;
  • FIG. 10 illustrates another schematic view of the endograft shown in FIG. 9, particularly illustrating both buffer sleeves and both stented grafts being installed relative to the graft body;
  • FIG. 1 1 illustrates a schematic view of another embodiment of a moderately supported graft body that may be used to form all or part of an endograft for the endovascular repair of abdominal aortic aneurysms in
  • FIG. 12 illustrates another schematic view of the moderately supported graft body shown in FIG. 1 1 with corresponding stented grafts configured to be received within the distal limbs of the graft body;
  • FIG. 13 illustrates a schematic view of a further embodiment of a moderately supported graft body that may be used to form all or part of an endograft for the endovascular repair of abdominal aortic aneurysms in accordance with aspects of the present subject matter, particularly illustrating the graft body including distal limbs of varying lengths;
  • FIG. 14 illustrates a schematic view of another embodiment of a three- piece endograft partially installed within the aorta shown in FIG. 2 relative to the infrarenal abdominal aortic aneurysm in accordance with aspects of the present subject matter, particularly illustrating the endograft including a moderately supported graft body configured to extend between the aortic neck and the common iliac arteries of the aorta and first and second stented tube inserts configured to be received within distal limbs of the graft body;
  • FIG. 15 illustrates another schematic view of the endograft shown in FIG. 14, particularly illustrating both stented tube inserts being installed relative to the graft body;
  • FIG 16 illustrates another schematic view of the moderately supported graft body shown FIG. 3, particularly illustrating the graft body including nonstructural location identifiers incorporated within or coupled to the distal limbs of the graft body.
  • moderately supported endograft generally refers to an endograft that has metal struts or other support structure over a portion of its length, but not over its entire length.
  • a moderately supported endograft differs from a "fully supported
  • endograft which refers to an endograft that has metal struts or other support structure over the entire length of the graft.
  • proximal and distal are used describe a relationship within the body relative to the heart, with the term “proximal” describing a closer position relative to the heart than the term “distal.” For instance, the knee is proximal to the foot but distal to the hip.
  • the present subject matter is directed to an endograft including a moderately supported graft body for use with the endovascular repair of abdominal aortic aneurysms.
  • the graft body may include a proximal tube portion configured to be secured to an aortic neck located proximal to the aneurysm and first and second distal limbs located distal to the proximal tube portion.
  • the proximal tube portion may include a stented section having a stent configured to provide structural support for the proximal tube portion.
  • the first and second distal limbs may be fully unsupported.
  • the first and second distal limbs may be non-stented or otherwise devoid of stents and other structural components.
  • Such unsupported distal limbs may increase the capability of the endograft to adapt to changes in the aneurysm conformation (e.g., when the aortic neck becomes angulated or the aneurysm shrinks longitudinally after being bypassed with an endograft).
  • the non-stented distal limbs may be less expensive to manufacture as compared to conventional fully stented limbs.
  • FIG. 1 illustrates a schematic view of an abdominal aorta 20 and its major branches.
  • the aorta 20 includes a suprarenal aorta portion 22, which corresponds to the portion of the aorta 20 that is superior to or proximal to the left and right renal arteries 24, 26.
  • the aorta 20 includes an infrarenal aorta portion 28, which corresponds to the portion of the aorta 20 that begins just inferior to the lower or more distal renal artery 24, 26 and extends to the bifurcation of the aorta 20.
  • a distal portion of the abdominal aorta divides into a left common iliac artery 30 and a right common iliac artery 32.
  • the right common iliac artery 32 divides into a right external iliac artery 34, which supplies blood flow to the right lower extremity, and a right internal iliac artery 36, which supplies arterial blood flow to the organs of the pelvis.
  • the left common iliac artery 30 divides into a left external iliac artery 38 and a left internal iliac artery 40, which supply blood flow to the left lower extremity and left pelvis, respectively. Additionally, as shown in FIG.
  • the aorta 20 includes small paired lumbar arteries 42 arising from the posterior portion of the infrarenal aorta portion 28 as well as an inferior mesenteric artery 44 arising from the left anteriorolateral portion of the infrarenal aorta portion 28. Moreover, orifices for the celiac artery 46 and the superior mesenteric artery 48 arise from the posterior portion of the suprarenal aorta portion 22.
  • FIG. 2 a schematic view of the abdominal aorta 20 described above with an infrarenal abdominal aortic aneurysm 50 is illustrated in accordance with aspects of the present subject matter.
  • the aneurysm 50 corresponds to a localized section of the infrarenal aorta portion 28 that is enlarged.
  • the infrarenal aorta portion 28 may also include an aortic neck 52, which generally corresponds to the non-dilated segment of the infrarenal aorta portion 28 extending between the renal arteries 24, 26 and the aneurysm 50.
  • FIG. 3 a schematic view of one embodiment of a moderately supported graft body 102 that may be used to form all or part of an endograft 100 for repairing an infrarenal abdominal aortic aneurysm 50 is illustrated in accordance with aspects of the present subject matter.
  • the graft body 102 is generally formed from a suitable graft material 104 and extends lengthwise between a proximal end 106 and a distal end(s) 108.
  • the graft body 102 may include a proximal tube portion 1 10 and two distal Iimbs1 12, 1 14 (e.g.
  • a first distal limb 1 12 and a second distal limb 1 14 with the proximal tube portion 1 10 extending lengthwise from the proximal end 106 of the body 102 to the distal limbs 1 12, 1 14 and the distal limbs 1 12, 1 14 extending lengthwise from the proximal tube portion 1 10 to the distal end(s) 108 of the body 102.
  • the proximal tube portion 1 10 of the graft body 102 may be stented or otherwise supported.
  • the graft body 102 may include a stent 1 16 extending along all or a portion of the lengthwise distance defined by the proximal tube portion 1 10 between the proximal end 106 of the body 102 and the distal limbs 1 12, 1 14.
  • the stent 1 16 may correspond to any suitable structure that provides support for the graft material 104 and/or provides a means for securing the proximal tube portion 1 10 to the aortic neck 50.
  • the stent 1 16 may correspond to a metallic stent forming a scaffolding-type structure that defines a diamond or zigzag pattern.
  • the stent 1 16 may be formed from any other suitable material and/or may define any other suitable pattern that allows the stent 1 16 to provide structural support to the proximal tube portion 1 10 of the graft body 102.
  • the stent 1 16 may be installed at any suitable location relative to the graft material 104.
  • the stent 1 16 may be sewn onto the inside of the graft material 104.
  • the stent 1 16 may be sewn onto the outside of the graft material 104 or placed between two layers of the graft material 104.
  • FIG. 4 illustrates an example cross-sectional view of a portion of the graft body 102 shown in FIG. 3 taken about line 4-4.
  • the graft material 104 includes both a first or outer layer 1 18 and a second or inner layer 120.
  • the stent 1 16 may be positioned between the inner and outer layers 1 18, 120 of the graft material 104.
  • the distal limbs 1 12, 1 14 of the graft body 102 may be completely unsupported or non-stented.
  • the distal limbs 1 12, 1 14 may be completely devoid of stents or other support structure.
  • the distal limbs 1 12, 1 14 may, for example, be formed entirely from the graft material 104.
  • additional non-support-related components such as one or more location identifiers 201 , 202, may also be incorporated into the distal limbs 1 12, 1 14.
  • the graft material 104 may generally correspond to any suitable material known in the art.
  • the graft material 104 may correspond to a woven polyester material (e.g. , DACRON).
  • the graft material 104 may be polytetraflouroethylene (PTFE) or any other suitable material.
  • the proximal tube portion 1 10 of the graft body 102 may include a first lengthwise tube section 122 positioned within the aortic neck 52 and a second lengthwise tube section 124 inferior to the aortic neck 52 that extends between the first lengthwise section 122 and the distal limbs 1 12, 1 14.
  • each distal limb 1 12, 1 14 may generally be configured to extend within the aortic aneurysm 52 from the second lengthwise tube section 124 of the proximal tube portion 1 10 to the distal end(s) 108 of the graft body 102.
  • a separate graft component(s) e.g. , a stented tube or stent-graft and/or a buffer sleeve
  • first lengthwise tube section 122 of the proximal tube portion 1 10 may be configured to be attached to the aortic neck 52 using any suitable attachment means known in the art.
  • first lengthwise tube section 122 may be attached to the aortic neck using fasteners
  • Example methods and/or fasteners for attaching the first lengthwise tube section 122 of the proximal tube portion 1 10 to the aortic neck 52 are described, for instance, in U.S. Pat. Nos. 5,957,940; 5,997,556; 6,248, 1 18;
  • the diameter of the first lengthwise tube section 122 of the proximal tube portion 1 10 may be oversized relative to the diameter of the aortic neck 52 to provide greater frictional attachment and, thus, enhanced sealing between the graft body 102 and the aortic neck 52.
  • the first lengthwise tube section 122 of the proximal tube portion 1 10 may be longer than the second lengthwise portion 124 of the proximal tube portion 1 10.
  • the first lengthwise tube section 122 may have a length 128 ranging from about 8 millimeters (mm) to about 12 mm, such as from about 9 mm to about 1 1 mm or from about 9.5 mm to about 10.5 mm
  • the second lengthwise tube section 124 may have a length 130 ranging from about 0.5 mm to about 3.5 mm, such as from about 1 mm to about 3 mm or from about 1 .5 mm to about 2.5 mm.
  • the stent 1 16 may be
  • the stent 1 16 may extend lengthwise along all or only a portion of the first lengthwise tube section 122 so that the stent 1 16 is positioned within the aortic neck 52.
  • a portion of the stent 1 16 may also be disposed within the second lengthwise tube section 124 of the proximal tube section 1 10 extending inferior or distal to the aortic neck 52.
  • FIGS. 6 and 7 a schematic view of one embodiment of a three-piece endograft 100 installed relative to the aortic aneurysm 50 shown in FIG. 2 is illustrated in accordance with aspects of the present subject matter.
  • the endograft 100 includes the graft body 102 described above with reference to FIGS. 3-5.
  • the endograft 100 includes first and second stented grafts 140, 142 configured to extend between the distal limbs 1 12, 1 14 of the graft body 102 and the common iliac arteries 30,32 such that the endograft 100 bridges the aneurysm between the aortic neck 52 and the common iliac arteries 30, 32.
  • FIG. 6 illustrates one of the stented grafts 140, 142 (e.g., the first stented graft 140) installed relative to the graft body 102 while the other stented graft 140, 142 (e.g., the second stented graft 142) is shown separate from the graft body 102. Additionally, FIG. 7 illustrates both of the stented grafts 140, 142 installed relative to the graft body 102. [0060] As particularly shown in FIG. 6, the stented grafts 140, 142 may correspond to separate components from the graft body 102.
  • each stent graft 140, 142 may be configured as an elongated tube formed from a suitable graft material 144 that extends lengthwise between a first end 146 and a second end 148. Additionally, as shown in the illustrated embodiment, each stented graft 140, 142 may be fully supported between its first and second ends 146, 148. For example, a stent(s) 150 may be provided between the first and second ends 146, 148 of each stented graft 140, 142 to provide structural support to the graft 140, 142.
  • the stented grafts 140, 142 may be installed relative to the graft body 102 and the aorta 20 such that a proximal portion 152 of each stented graft 140, 142 is received within and secured to one of the distal limbs 1 12, 1 14 and a distal portion 154 of each stented graft 140, 142 is received within and secured to one of the common iliac arteries 30, 32.
  • an intermediate portion 156 of each stented graft 140, 142 may be provided between the proximal and distal portions 152, 154 such that the proximal portion 152 of each stented graft 140, 142 extends lengthwise between the first end 146 of the stented graft 140, 142 and the intermediate portion 156 and the distal portion 154 of each stented graft 140, 142 extends lengthwise between the intermediate portion 156 and the second end 148 of the stented graft 140, 142.
  • the stented grafts 140, 142 may serve to bridge the gap between the graft body 102 and the common iliac arteries 30, 32.
  • the diameter of the proximal portion 152 of the stented grafts 140, 142 may be oversized relative to the diameter of the distal limbs 1 12, 1 14 to provide greater frictional attachment between the stented grafts 140, 142 and the distal limbs 1 12, 1 14.
  • FIG. 8 illustrates an embodiment of the endograft 100 shown in FIG. 6 in which the graft material 104 used to form lower portions of the distal limbs 1 12, 1 15 has been modified.
  • FIG. 8 illustrates a partial cross-sectional view of a portion of one of the distal limbs 1 12 (e.g. , the second distal limb 1 14).
  • the graft material 104 may be modified by increasing the thickness of the material 104 along the lower portions 158 of the distal limbs 1 12, 1 14.
  • the graft material 104 forming the lower portions 158 of the distal limbs 1 12, 1 14 may have a material thickness 160 that is greater than the material thickness 162 of the remainder of the graft body 102.
  • the graft material 104 may be modified by adjusting its composition relative to the remainder of the graft body 102.
  • the lower portions 158 of the distal limbs 1 12, 1 14 may be formed from a graft material 104 that differs from the graft material 104 used to form the remainder of the graft body 102.
  • the graft material 104 may be consistent throughout the graft body 102 but the lower portions 158 of the distal limbs 1 12, 1 14 (or the entirety of the distal limbs 1 12, 1 14) may incorporate stronger fibers relative to the fibers used throughout the remainder of the graft body 102.
  • the inner surface of the distal limbs 1 12, 1 14 may be modified to include one or more components and/or features designed to facilitate securing the stented grafts 140, 142 to the distal limbs 1 12, 1 13, such as configuring the inner surface to include hooks or loops (e.g. , a Velcro-like substance), glue (e.g. , typical glue or glue that is temperature activated or activated using another energy source), barbs and/or any other suitable features.
  • hooks or loops e.g. , a Velcro-like substance
  • glue e.g. , typical glue or glue that is temperature activated or activated using another energy source
  • barbs e.g., typical glue or glue that is temperature activated or activated using another energy source
  • the endograft 100 may also include a buffer sleeve positioned within each distal limb 1 12, 1 14 to provide a "buffer layer" between the graft body
  • FIGS. 9 and 10 illustrates an embodiment of the endograft 100 shown in FIGS. 6 and 7 that includes first and second buffer sleeves 170, 172 configured to be positioned between each distal limb 1 12, 1 14 and the adjacent stented graft 140, 142.
  • first and second buffer sleeves 170, 172 configured to be positioned between each distal limb 1 12, 1 14 and the adjacent stented graft 140, 142.
  • FIG. 9 illustrates one of the buffer sleeves 170, 172 (e.g. , the first buffer sleeve
  • the second buffer sleeve 172 separated from the graft body 102, with both of the stented grafts 140, 142 being separated from the graft body 102.
  • FIG. 10 illustrates the buffer sleeves 170, 172 and the stented grafts 140, 142 installed relative to the graft body 102.
  • each buffer sleeve 170, 172 may correspond to separate components from the graft body 102.
  • each buffer sleeve 170, 172 may be configured to be installed within one of the distal limbs 1 12, 1 14 such that the buffer sleeve 17p, 172 is at least partially received within the corresponding distal limb 1 12, 1 14.
  • each buffer sleeve 170, 172 may include a proximal portion 174 received within its respective distal limb 1 12, 1 14 and a distal portion 176 extending outwardly from the distal end 108 of the distal limb 1 12, 1 14.
  • each buffer sleeve 170, 172 may be configured to be installed within the graft body 102 such that the entire sleeve 170, 172 is positioned within its respective distal limb 1 12, 1 14.
  • the stented grafts 140, 142 may generally be installed relative to the graft body 102 and the aorta 20 similar to that described above with reference to FIGS. 6 and 7.
  • the proximal portion 152 of each stented graft 140, 142 may be received within one of the distal limbs 1 12, 1 14 and the distal portion 154 of each stented graft 140, 142 may be received within of the common iliac arteries 30, 32.
  • FIG. 9 the stented grafts 140, 142 may generally be installed relative to the graft body 102 and the aorta 20 similar to that described above with reference to FIGS. 6 and 7.
  • the proximal portion 152 of each stented graft 140, 142 may be received within one of the distal limbs 1 12, 1 14 and the distal portion 154 of each stented graft 140, 142 may be received within of the common iliac arteries 30, 32.
  • each stented graft 140, 142 may be received directly within the adjacent buffer sleeve 170, 172 such that the buffer sleeves 170, 172 are positioned between the stented grafts 140, 142 and the corresponding distal limbs 1 12, 1 14.
  • the buffer sleeves 170, 172 may have any suitable configuration and/or may be formed from any suitable material.
  • the buffer sleeves 170, 172 may be composed of any combination of graft material, fabric, stents, and/or barbs.
  • each buffer sleeve may have any suitable configuration and/or may be formed from any suitable material.
  • the buffer sleeves 170, 172 may be composed of any combination of graft material, fabric, stents, and/or barbs.
  • each buffer sleeve may have any suitable configuration and/or may be formed from any suitable material.
  • the buffer sleeves 170, 172 may be composed of any combination of graft material, fabric, stents, and/or barbs.
  • each buffer sleeve may have any suitable configuration and/or may be formed from any suitable material.
  • the buffer sleeves 170, 172 may be composed of any combination of graft material, fabric, stents, and/or barbs.
  • each buffer sleeve may have any suitable configuration and
  • each buffer sleeve 170, 172 may correspond to a stented graft having barbs along its exterior such that, when the sleeve 170, 172 is dilated against its respective distal limb 1 12, 1 14, the barbs completely or partially penetrate through the wall(s) of the distal limb 1 12, 1 14.
  • the barbs may be provided on the stented graft 140, 142 such that the barbs penetrate at least partially through the adjacent buffer sleeve 170, 172 and/or the corresponding portion of the distal limb 1 12, 1 14.
  • the buffer sleeves 170, 172 may be formed from the same graft material 104 as the graft body 102 such that the portions of the distal limbs 1 12, 14 within which each buffer sleeve 170, 172 is installed define increased material thicknesses.
  • the distal limbs 1 12, 1 14 of the graft body 102 may generally be configured to define any suitable shape.
  • the distal limbs 1 12, 1 14 are generally cylindrically shaped along their length.
  • the distal limbs 1 12, 1 14 may have any other suitable shape.
  • FIGS. 1 1 and 12 illustrate an embodiment of the graft body 102 in which the distal limbs 1 12, 1 14 define a non-cylindrical lengthwise shape. Specifically, as shown FIG.
  • each distal limb 1 12, 1 14 includes both a diverging lengthwise section 180 along which the diameter of the distal limb 1 12, 1 14 increases as the limb 1 12, 1 14 extends away from the proximal tube portion 1 10 towards the distal end(s) 108 of the graft body 102 and a converging lengthwise section 182 along which the diameter of the distal limb 1 12, 1 14 decreases as the limb 1 12, 1 14 extends towards the distal end(s) 108 of the graft body 102.
  • the stented grafts 140, 142 may be similarly shaped to as to correspond to all or a portion of the non- cylindrical lengthwise shape of the distal limbs 1 12, 1 14. For example, as shown in FIG.
  • each stented graft may include a converging lengthwise portion 184 along which the diameter of the stented graft 140, 142 decreases as the graft 140, 142 extends from its first end 146 to its second end 148.
  • the converging lengthwise portions 184 of the stented grafts 140, 142 may then be received within the converging lengthwise portions 182 of the distal limbs 1 12, 1 14 when coupling the stented grafts 140, 142 to the graft body 102.
  • distal limbs 1 12, 1 14 may generally be configured to define any suitable length.
  • the distal limbs 1 12, 1 14 generally define the same length.
  • the lengths of the distal limbs 1 12, 1 14 may generally be configured to define any suitable length.
  • FIG. 13 illustrates an embodiment of the graft body 102 having distal limbs 1 12, 1 14 that define varying lengths.
  • the first distal limb 1 12 defines a length 186 that is longer that a corresponding length 188 of the second distal limb.
  • the length(s) of the stented grafts 140, 142 may be modified to accommodate the differing lengths 186, 188 of the distal limbs 1 12, 1 14.
  • each distal limb 1 12, 1 14 of the graft body 102 extends lengthwise from the proximal tube portion 1 10 and terminates within one of the common iliac arteries 30, 32.
  • each distal limb 1 12, 1 14 may include a first lengthwise limb portion 190 extending within the aortic aneurysm 50 and a second lengthwise limb portion 192 extending within one of the corresponding common iliac arteries 30, 32.
  • a separate stented tube insert 194, 195 may be inserted within the second lengthwise limb portion 192 of each distal limb 1 12, 1 14.
  • FIGS. 14 and 15 illustrates first and second stented tube inserts 194, 195 that may be configured to be received within the first and second distal limbs 1 12, 1 14, respectively.
  • FIG. 14 illustrates the stented tube inserts 194, 195 separate from the graft body 102.
  • FIG. 15 illustrates both of the stented tube inserts 194, 195 installed relative to the graft body 102.
  • the stented tube inserts 194, 195 may generally be configured the same as or similar to the stented grafts 140, 142 described above.
  • the stented tube inserts 194, 195 may correspond to separate components from the graft body 102.
  • Each tube insert 194, 195 may be configured as an elongated tube formed from a suitable graft material that extends lengthwise between a first end 196 and a second end 197. Additionally, as shown in the illustrated embodiment, each tube insert 194, 195 may be fully supported between its first and second ends 196, 197.
  • each stented tube insert 194, 195 may be inserted within the second lengthwise limb portion 192 of each distal limb 1 12, 1 14 to provide a means for attaching the distal limb 1 12, 1 14 to its respective common iliac artery 30, 32.
  • the stented tube inserts 194, 195 may be configured to extend entirely within the second lengthwise limb portion 192 of each distal limb 1 12, 1 14.
  • a portion of each stented tube insert 194, 195 may be configured to extend proximally beyond the second lengthwise limb portion 192 into the first lengthwise limb portion 192 of each distal limb 1 12, 1 14.
  • one or more nonstructural location identifiers may be provided in association with the disclosed graft body 102.
  • FIG. 16 illustrates one embodiment of suitable nonstructural location identifiers 201 , 202 that may be used with the disclosed graft body 102.
  • the location identifiers 201 , 202 may correspond to radiopaque location identifiers.
  • one or more radiopaque markers 201 and/or radiopaque wires 202 may be incorporated into or coupled to the graft body 102.
  • the radiopaque location identifiers 201 , 202 may be used to facilitate radiological identification during insertion and/or assembly of the endograft 100. However, given the nature of the location identifiers 201 , 202, such identifiers 201 , 202 may not provide any structural support to the graft body 102.
  • the location identifiers 201 , 202 are positioned on or within the distal limbs 1 12, 1 14, such as being located at or adjacent to the distal end(s) 108 of the graft body 102.
  • the location identifiers 201 , 202 may be positioned at any other suitable location on or within the graft body 102.

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  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Selon un aspect de l'invention, un endogreffon pour la réparation endovasculaire d'une aorte abdominale présentant un anévrisme aortique et un col aortique peut généralement comprendre un corps de greffon modérément supporté s'étendant dans le sens de la longueur entre une extrémité proximale et une extrémité distale. Le corps de greffon peut comprendre une partie tube proximal et des premier et second membres distaux. La partie tube proximal peut s'étendre dans le sens de la longueur entre l'extrémité proximale du corps de greffon et les premier et second membres distaux. Les premier et second membres distaux peuvent s'étendre dans le sens de la longueur entre la partie tube proximal et l'extrémité distale du corps de greffon. La partie tube proximal peut comprendre une section à stent comportant un stent conçu pour fournir un support structural à la partie tube proximal. De plus, le premier et le second membre distal peuvent correspondre à des parties ne comportant pas de stent du corps de greffon.
PCT/US2016/024136 2015-03-27 2016-03-25 Endogreffons améliorés pour la réparation endovasculaire d'anévrismes aortiques abdominaux WO2016160540A1 (fr)

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Citations (13)

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Publication number Priority date Publication date Assignee Title
WO1996007370A1 (fr) * 1994-09-02 1996-03-14 W.L. Gore & Associates, Inc. Forme asymetrique en ptfe poreux, et procede de fabrication
WO1997043983A1 (fr) * 1996-05-24 1997-11-27 Meadox Medicals, Inc. Protheses tubulaires tissees et formees pour tissus mous, et procedes de fabrication
US5957940A (en) 1997-06-30 1999-09-28 Eva Corporation Fasteners for use in the surgical repair of aneurysms
US5997556A (en) 1997-06-30 1999-12-07 Eva Corporation Surgical fastener
EP1029518A2 (fr) * 1999-02-16 2000-08-23 Hector Daniel Barone Prothèse aortique et méthode d'utilisation pour le traitement d'un anévrisme aortique abdominal
US6248118B1 (en) 1997-06-30 2001-06-19 Eva Corporation Heat activated surgical fastener
US6520974B2 (en) 1997-06-30 2003-02-18 Eva Corporation Surgical fastener
US20030120263A1 (en) * 2001-12-20 2003-06-26 The Cleveland Clinic Foundation Apparatus and method for capturing a wire in a blood vessel
US6635066B2 (en) 1997-06-30 2003-10-21 Eva Corporation Surgical fastener for use during a surgical procedure
US20060217796A1 (en) * 2005-03-25 2006-09-28 Dimatteo Kristian Variable length endovascular graft prosthesis adapted to prevent endoleaks
WO2007079081A1 (fr) * 2005-12-29 2007-07-12 Med Institute, Inc. Dispositif endoluminal comprenant un mecanisme de fixation proximale ou distale et procedes d'utilisation de ce dernier
US20110130819A1 (en) * 2009-12-01 2011-06-02 Altura Medical, Inc. Modular endograft devices and associated systems and methods
WO2014071236A1 (fr) * 2012-11-05 2014-05-08 Medtronic Vascular Inc. Mécanismes de fixation de pattes l'une à l'autre d'une structure de greffe bifurquée lors du déploiement initial

Patent Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996007370A1 (fr) * 1994-09-02 1996-03-14 W.L. Gore & Associates, Inc. Forme asymetrique en ptfe poreux, et procede de fabrication
WO1997043983A1 (fr) * 1996-05-24 1997-11-27 Meadox Medicals, Inc. Protheses tubulaires tissees et formees pour tissus mous, et procedes de fabrication
US6520974B2 (en) 1997-06-30 2003-02-18 Eva Corporation Surgical fastener
US5997556A (en) 1997-06-30 1999-12-07 Eva Corporation Surgical fastener
US6248118B1 (en) 1997-06-30 2001-06-19 Eva Corporation Heat activated surgical fastener
US5957940A (en) 1997-06-30 1999-09-28 Eva Corporation Fasteners for use in the surgical repair of aneurysms
US6635066B2 (en) 1997-06-30 2003-10-21 Eva Corporation Surgical fastener for use during a surgical procedure
EP1029518A2 (fr) * 1999-02-16 2000-08-23 Hector Daniel Barone Prothèse aortique et méthode d'utilisation pour le traitement d'un anévrisme aortique abdominal
US20030120263A1 (en) * 2001-12-20 2003-06-26 The Cleveland Clinic Foundation Apparatus and method for capturing a wire in a blood vessel
US20060217796A1 (en) * 2005-03-25 2006-09-28 Dimatteo Kristian Variable length endovascular graft prosthesis adapted to prevent endoleaks
WO2007079081A1 (fr) * 2005-12-29 2007-07-12 Med Institute, Inc. Dispositif endoluminal comprenant un mecanisme de fixation proximale ou distale et procedes d'utilisation de ce dernier
US20110130819A1 (en) * 2009-12-01 2011-06-02 Altura Medical, Inc. Modular endograft devices and associated systems and methods
WO2014071236A1 (fr) * 2012-11-05 2014-05-08 Medtronic Vascular Inc. Mécanismes de fixation de pattes l'une à l'autre d'une structure de greffe bifurquée lors du déploiement initial

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