~=
`
`NON
`27805
`PATENT TRADEMARK OFFICE
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`PROVISIONAL APPLICATION FOR PATENT COVER SHEET
`This is a requestfor filing a PROVISIONAL APPLICATION FOR PATENTunder 37 CFR 1.53(c).
`
`
`AVfo
`
`=
`
`"S'NZe80L
`
`Old
`
`+ 2
`
`0/22/10WON
`
`TimurP.
`
`Sarac
`
`Cuyahoga, Ohio
`
`C]
`
`Additional inventors are being named on the ___
`separately numbered sheets attached hereto
`TITLE OF THE INVENTION(280 characters max)
`PERCUTANEOUS ENDOVASCULAR GRAFT FOR REPAIR OF ANEURYSMS
`
`Residence
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`059399-002
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`MEDTRONIC 1147
`
`MEDTRONIC 1147
`
`

`

`Attorney Docket No. 059399-002
`
`27805
`PATENT TRADEMARKOFFICE
`
`Percutaneous Endovascular Graft for Repair of Aneurysms
`
`Technical Field
`
`to an endovascular graft system for the treatment
`The present invention relates generally
`of aneurysms, and more
`to an endovascular graft system having
`an
`particularly,
`expandable
`the endovascular graft system to an interior wall of a lumen.
`
`attachment device for
`
`securing
`
`Background
`
`An abdominal aortic aneurysmis an abnormal
`arterial wall of the aorta in a
`
`or
`
`out” of the
`
`enlargement
`“ballooning
`region that passes through the abdominal cavity, usually below the.
`renal arteries and above the commoniliac arteries. The aneurysm may
`extendinto the
`also
`on
`commoniliac arteries. Such aneurysmsare
`by the weakeningof the arterial
`typically brought
`wall from vascular disease. Although abdominal aortic aneurysms often do not cause
`a fatal
`an ancurysm may rupture causing
`hemorrhagein a
`unless treated,
`
`pain,
`
`patient.
`
`In the past aortic aneurysms were treated almost exclusively by surgical repair.
`anartificial artery known as a
`Specifically, the aneurysm would be resected and replaced by
`prosthetic graft. Because of the substantial risks associated with such an invasive surgery,
`however, other treatments for aortic aneurysms have been proposed including endovascular
`
`grafting.
`
`placement of a
`involves the
`Endovascular
`prosthetic graft within the lumen of
`grafting
`the artery such that the graft spans the length of the aneurysm. In this manner the aneurysm can
`a catheter as a
`be excluded from the
`circulatory system rather than resected. Using
`deployment
`can be introduced into the vascular system percutaneously. Once
`device, the endovascular graft
`at the site of the aneurysm it can be attached to the vascular wall
`the
`graft has been positioned
`both above and below the aneurysm using expandable attachment devices to prevent movement
`of the graft after deployment.
`
`To introduce an endovascular
`
`graft percutaneously, the graft
`collapsible
`small
`profile for negotiating the vascular system. Upon reaching the site of the aneurysm the
`graft and its atlachment devices can be
`expandedinto a desired shape using
`an
`inflating balloon
`
`must be
`
`into a
`
`10
`
`20
`
`25
`
`
`
`

`

`Beh
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`LN a gee LW pet
`
`Attorney Docket No. 059399-002
`
`of
`
`catheter or other actuator. A
`expandable attachment devices have been proposed for
`variety
`to an interior wall of a vessel most of which use stents with hooks
`an endovascular graft
`securing
`or barbs to penetrate the intima of the vessel. None of the proposed attachment devices,
`ideally suited for use with an endovascular graft system.
`however, have been foundto be
`
`an endovascular
`expandable attachment deviceis
`graft system having
`Accordingly
`desired. The new attachment device ideally should be small with a low
`profile and should
`to many timesits initial diameter. It also should exert enoughradial force when
`expand
`expandedto fix into the aorta and
`
`thereby
`
`reduce blood leaks around the graft system.
`
`a new
`
`Summary
`
`an
`
`to stents. The
`
`a
`
`In a first aspect,
`an endovasculargraft
`expandable attachment device for securing
`an interior wall of a lumen is provided. The
`expandable attachment device includesa
`plurality
`armsthat are
`an
`joined together to
`expandable ring. This ring may function
`telescoping
`form
`expandable attachment device may be attached to an endovascular
`similarly
`graft
`and may
`or
`fasteners about its perimeter for attaching to the interior
`include barbs,
`other
`hooks,
`wall of a lumen. Because the attachment device can be collapsed to a size that can be fed
`can be
`vessel, the attachment device and an associated endovascular graft
`through
`percutancously in a
`at the site of an
`patient. Once positioned
`aneurysm, the telescoping
`attachment device can be expandedto hold the endovasular graft
`in
`place adjacent the inner
`lumen wall.
`
`to
`
`of
`
`deployed
`
`10.
`
`15
`
`20
`
`25
`
`In a second aspect
`an endovasculargraft system is provided for treating aneurysms using
`a minimally invasive technique. The graft system
`a cranial end
`includes a tubular sleeve having
`and at least one caudal branch. If the tubular sleeve includesa first caudal branch and a second
`caudal branch then the tubular sleeve is shaped like an
`upside down “Y.”
`Accordingly, for the
`the cranial end may
`treatment of abdominalaortic
`bepositioned in the infrarenal
`aneurysms
`aorta, the first caudal branch may be positioned in one of the commoniliac arteries, and the
`second caudal branch may
`be positioned in the other commoniliac artery. The tubular sleeve
`may be made from matcrials conventionally used to make endovascular grafts including
`synthetic fabrics or
`or
`films, Dacron TM,
`
`expanded polytetrafluoroethylene (ePTFE)so
`
`as to
`
`
`
`

`

`Attorney Docket No. 059399-002
`
`
`
`define a lumen and so as to be collapsible during percutaneousinsertion into a
`system.
`
`patient’s
`
`vascular
`
`attachment device attached to the cranial
`
`The graft system further includes an
`expandable
`end of the tubular sleeve for securing the graft system to an interior wall of a vessel above an
`a
`arms that are
`aneurysm. The expandable attachment device comprises
`plurality of
`telescoping
`attached to form an
`armis similar to an
`expandable ring. Each
`telescoping
`expandable
`presentation pointer. Accordingly, during percutaneous insertion of the endovasculargraft
`system into a
`patient, the attachment device can be collapsed into a small profile. Oncethe graft
`at the site of the aneurysm, the expandable attachment device can be
`system is
`positioned
`expandedto hold the endovasular
`graft system in place adjacent the inner lumen wall. Fixation
`may
`be positioned around the
`perimeter of the attachment device and may be
`components
`embedded in the inner wall of the vessel to secure the attachment device.
`
`partially
`
`10
`
`The
`
`arms may be made from stainless steel or an
`plurality of telescoping
`alloy of nickel
`known as “Nitinol.” Nitinol is
`and titanium
`commonly used in the manufacture of
`generally
`medical devices that are to be
`deployed in a
`a catheter becauseof its
`compressedstate through
`unique thermal memory
`a Nitinol part may be manufacturedin first
`For
`properties.
`example,
`condition and then cooled and compressed into a second condition. Whenheated to the body
`temperature of the patient the Nitinol part will expand toits
`original first condition.
`
`20
`
`one or more
`
`expandable attachment devices may
`be attachedto the one
`In another aspect
`or more caudal branchesof the tubular sleeve for securing
`the one or more caudal branchesto the
`interior of the vessel wall.
`
`Brief Description of the
`
`Drawings
`
`Figure
`
`1 is a schematic illustration of an endovascular graft system according
`
`to a first
`
`aspect;
`
`25
`
`Figures
`
`2A-D show the endovascular
`
`graft system of Figure
`
`1 in various states or
`
`expansion;
`
`
`
`

`

`Laney com «
`
`eh a4
`Le aw
`
`
`ES CP gee get lg
`
`Attorney
`
`Docket No. 059399-002
`
`Figure 3 is a schematic illustration of an endovasucular graft system according
`second aspect;
`
`to a
`
`Figure 4A is a
`
`top view of an
`
`expandable attachment device accordingto
`
`first aspect in
`
`a
`
`fully collapsed state;
`
`Figure 4Bis a
`
`top view of the expandable attachment device of Figure 4A in a
`
`partially
`
`expandedstate;
`
`Figure 4C is a
`
`top view of the expandable attachment device of Figure 4A in a
`
`fully
`
`expandedstated;
`
`Figure 5 is a
`
`locking mechanism accordingto
`
`a first aspect in a first position;
`
`.
`
`10
`
`Figure
`
`6 is the
`
`locking mechanism of
`
`Figure
`
`5 in a second position;
`
`Figure
`
`7 is a cross section of a
`
`segment of the telescoping
`
`arm of
`
`Figure 4C;
`
`Figure
`
`8 is an endovascular graft system according
`
`to a third aspect;
`
`9 is an endovascular
`
`Figure
`
`graft system according
`
`to a fourth aspect;
`
`15
`
`20
`
`10 is an illustration of a
`
`Figure
`infrarenal aorta; and
`
`typical abdominalaortic aneurysm located in the
`
`11 is a catheter for percutaneous introduction of an endovascular
`
`graft system into
`
`Figure
`body lumen.
`
`a
`
`Detailed Description
`
`to a first aspect is shown in
`Anendovascular graft system 10
`according
`Fig.
`a cranial end 14,a first caudal
`graft system 10 includes a tubular sleeve 12
`endovascular
`having
`branch 16, and a second caudal branch 18. In other embodiments, termed “uni-iliac’”’ devices, the
`a
`tubular sleeve 12 may includeonly
`single caudal branch. The tubular sleeve may be made
`or fascia so as to form a flow
`an
`from Dacron, ePTFE, peritoneum,
`path for by-passing
`
`1. The
`
`ancurysm.
`
`
`
`

`

`Attorney Docket No. 059399-002
`
`A TsEe ERS WTOP yees
`
`
`
`The endovascular graft system 10 further includesa first expandable attachment device
`a second expandable attachment device
`20 attached to the cranial end 14 of the tubular sleeve 12,
`22 attachedto the first caudal branch 16 of the tubular sleeve 12, and a third
`expandable
`attachment device 24 attachedto the second caudal branch 18 of the tubular sleeve 12. The
`24 may
`sewn or sutured to
`expandabic attachment devices 20, 22,
`include holes 26 which may be
`in lieu of holes 26, the expandable attachment devices can
`be woven into the sleeve. In addition, the endovascular graft system 10 may include a
`fourth
`attachment device 28 that is attached to the first expandable attachmentdevice 20 by
`expandable
`support columns 30. The fourth expandable attachment device 28 may be located in a
`position. The support columns 30, which may be made from Nitinol or stainless steel, may
`columnar support and strength for the endovascular
`graft system 10 in the suprarenal
`30 maybeeither wires or tubes.
`The support columns
`Asillustrated in Figs.
`2A-2D, the endovascular graft system 10 is collapsible for easy
`navigation through a patient’s yascular system using a catheter. Particularly,
`as
`insertion and
`illustrated in Fig. 2A, the attachment devices 20, 22, 24,and 28 may beradially collapsed into a
`that is small enoughto fit in a catheter sheath. When the attachment devices 20, 22, 24,
`deployed from the sheathat body temperature, the devices may be expandedbya balloon
`or other actuator to a size and shape
`in which theyare able to retain the sleeve 12
`the wall
`of a vessel.
`
`the tubular sleeve 12.
`
`Alternatively,
`
`provide
`
`position.
`
`profile
`28 are
`
`suprarenal
`
`against
`
`10
`
`15
`
`.
`
`20
`
`25
`
`-
`
`3 in which
`
`to a second aspect is shown
`The endovascular graft system 10
`according
`Fig.
`the tubular sleeve 12 is supported by support columns 32. The support columns 32 may attach
`attachment device 20 to a fifth
`attachment device 34. Likewise,
`‘the first expandable
`expandable
`the support columns 32 may
`attach the second and third expandable attachment devices 22, 24 to
`ofthe first caudal
`fifth expandable attachment device 34 which may
`belocated at the juncture
`the
`branch 16 and the second caudal branch 18 of the tubular sleeve 12. In addition the support
`columns 32 may be sewnor sutured to the exterior of the tubular sleeve 12. This may provide
`continued columnar support throughout the endovascular graft system 10 to
`prevent migration
`within the vessel.
`
`
`
`

`

`Attorney
`
`Docket No. 059399-002
`
`Be Aoh aS IP sac back
`
`to
`
`an
`
`expandable attachment device 20 is shownin
`Fig. 4A,
`fully collapsed
`Referring
`state. The attachment device 20 includesa
`plurality of fixation components 36 positioned
`the perimeter of the device 20. A port 38 is located at the center of the attachment device 20.
`The port 38 is sized so as to receive a balloon or other actuator
`during deployment. The balloon
`may be inflated to expandthe altachmentdevice 20 after insertion into a vessel.
`4B shows
`Fig.
`the attachmentdevice 20 in a
`state. Fig. 4C showsthe attachment device 20
`partially expanded
`
`about
`
`in a
`
`|
`fully expanded
`
`state.
`
`an
`
`Referring to Fig. 4C, a telescoping arm 40 is used to attach each fixation component36 to
`arm 40 may
`be pivotably attached to a
`adjacent fixation component 36. The telescoping
`arm 40 is made up of a
`fixation component36 at one or both ends of the arm 40. A telescoping
`of segments 42. The segments 42 may
`bein slidable contact with one another and may
`plurality
`arms 40 are
`be incrementally sized so as to fit within one another. When the telescoping
`extended the attachment devicc 20 may resemble a
`polygon having fixation
`components
`located at its vertices. As one of ordinary skill might appreciate, the attachment device may take
`arms 40 and the fixation
`variety of shapes depending uponthe configuration of the telescoping
`components 36. The fixation components 36 may include barbs or prongs 67 (shownin Fig. 8)
`for fixation to a vessel wall.
`
`fully
`
`36
`
`To keep the
`may
`a one-way
`
`g arms 40 in their final extended state after deploymentin a vessel,
`telescopin
`usedto lock adjacent segments 42. Fig. 5 shows one
`possible latch 44,
`be
`latch
`arms 40. The latch 44 may consist of a one or
`in a first position,
`for locking the telescoping
`more grooves 46 associated with a first segment 48 and a tooth 50 associated with a second,
`arm 40 is expanded, the second segment 52 moves ina
`adjacent segment 52. As the telescoping
`so
`first direction A relative to the first segment 48. The tooth 50 and the grooves 46 are aligned
`a
`arm 40 is extended. Once the tooth 50 engages
`as to engage whenthe
`groove 46,
`telescoping
`as shownin Fig. 6, the second segment 52 may not move in a second direction B relative to the
`arm 40is free to extend but may
`first segment 48. Accordingly, the telescoping
`not collapse
`once extended. Of course other one-way latches may be used to lock the segments 42 of the
`possible cross-section of a
`7 illustrates one
`arms 40. Fig.
`segment 42 of the
`roomfor sliding and positioning of a one-way
`arm 40. This “rail” design permits
`telescoping
`latch, like the one shownin Fig. 5, between segments 42 shownin Fig.
`4.
`
`telescoping
`
`°
`
`10
`
`20
`
`25
`
`30
`
`
`
`

`

`Attorney
`
`Docket No. 059399-002
`
`fey Wop eg Beg a Bg og a pel per
`
`
`an
`
`to a third aspect. In the
`Fig. 8 showsthe endovascular graft system 10 according
`shownin Fig. 8, the endovascular graft system 10 includes a
`double-expandable
`embodiment
`attachment device 60 in the
`of the first expandable attachment device 20. The double-
`place
`upper expandable attachment device 62 and a
`attachment device 60
`comprises
`expandable
`lower expandable attachment device 64 which are
`separated by and attached to an
`seal 66.
`o-ring
`The upper attachment device 62 is angularly offset from the lower attachment device 64 so that
`the fixation components 36 of each are offset. The fixation components 36 may
`include prongs
`or barbs 67 to aid in
`attachment devices 62, 64 to the vessel wall. This
`the
`securing
`expandable
`design provides for secure attachment to the vessel wall with reduced
`leakage around the
`of the attachment device 60. The lower
`expandable attachment device 64 may be
`perimeter
`attached to the tubular sleeve 12. The upper expandable attachment device 62 may be attached
`to the fourth
`attachment device 28
`by support columns 30.
`Referring to Fig. 9, the endovascular graft system 10 according to fourth aspect is shown.
`68 are attached to the cranial end 14 of tubular
`In this embodimenta
`plurality of “M
`springs”
`graft expandersin orderto hold the tubular sleeve 12 open. In this manner the M
`aroundthe perimeter of the tubular sleeve 12. M springs 68 may
`68 may reduce leakage
`springs
`also be used to hold the caudal ends 16, 18 of the tubular sleeve 12 open. In the embodiment
`springs 68 arc not attached to the segments 52 of the
`arms 40
`Fig. 9, the M
`telescoping
`and are located on the exterior of the tubular sleeve 12. In another embodiment, the M
`springs
`68 may be located onthe interior of the tubular sleeve 12 or attached to the fixation components
`of the “M
`in the shape ofa “V” may be used.
`36. Of course, in
`
`5
`
`10
`
`15
`
`20
`
`expandable
`
`sleeve 12 as
`
`shownin
`
`place
`
`springs” 68, springs
`
`10 illustrates a
`
`typical abdominal aortic aneurysm 70 located in the infrarenal aorta
`Fig.
`of the aorta 72 located below the renal arteries 74, 76.
`71. The infrarenal aorta 71 is that
`portion
`occur below the renal arteries 74, 76
`As shown in
`Fig. 10, abdominal aortic aneurysms typically
`and above the commoniliac arteries 78, 80. In some cases, the aneurysm includes the common
`an
`graft system 10 may be used lo treat or
`iliac arteries 78, 80. The endovascular
`repair
`abdominal aortic aneurysm 70, like the one shown in Fig. 10, by excluding the weakened
`In addition, the endovasculargraft
`flow.
`aneurysmal aortic wall from pressurized and
`pulsatile
`system 10 may
`body lumens suchasthe thoracic
`usedto treat aneurysmslocated in other
`be
`aorta, iliac arteries or subclavian arteries.
`
`25
`
`.
`
`30
`
`
`
`

`

`
`
`ney
`
`steers ete
`
`Attorney Docket No. 059399-002
`
`The endovascular graft system 10 may be deployedat the site of an aneurysm
`a catheter 82 like the one shownin Fig. 11. The catheter 82 may have an
`percutaneously using
`a sheath 86 and an
`introducer 88 which can be withdrawn within the sheath 86.
`IV port 84,
`Using the catheter 82, the device can be introduced
`percutaneously through either of the femoral
`
`arteries.
`
`During deploymentthe first expandable attachment device 20 may bepositioned just
`below therenalarteries 74, 76 and seated with an
`or other actuator. The
`expandable balloon
`device 28 may be positioned superiorto the renal
`fourth expandable attachment
`arteries 74, 76
`and seated with an
`expandable balloon. After the first attachment device 20 is seated, the
`iin
`“second
`device 22
`be
`first iliac artery 78 and seated
`expandable attachment
`positioned
`with an
`may
`attachment device 24 may
`expandable balloonor other
`actuator.The thirdéxpandable
`suchthat it rests at a
`andseatthe third
`be positioned
`To position
`iliac artery 80.
`second
`obtained percutaneously throughthe secondiliac artery 80.
`attachment device 24,
`be
`
`access,may
`
`*
`
`10
`
`
`
`

`

`Attorney Docket No. 059399-002
`
`Abstract
`
`
`
`for
`An endovascular graft system is
`treating aneurysms using
`provided
`percutaneous, minimally invasive technique. The graft system includes a tubular sleeve which
`may have a cranial end,a first caudal branch, and a second caudal branch suchthat the tubular
`like an
`down “Y.” The graft system further includes at least one
`sleeve is
`shaped
`upside
`securing the graft system to an
`expandable attachment device attached to the tubular sleeve for
`interior wall of a vessel. The at least one
`attachment device includes a
`of
`expandable
`telescoping segments similar to the telescoping segments of a
`presentation pointer. Accordingly,
`during percutaneousinsertion of the endovascular graft system into a
`the attachment
`patient
`into a small profile.
`device can be collapsed
`at the site of the aneurysm the
`Once
`attachment device can be expandedto hold the endovasular graft system in place
`telescoping
`adjacent the inner lumen wall.
`
`a
`
`plurality
`
`10
`
`positioned
`
`
`
`

`

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