United States Patent [19]
`Lazarus
`
`USOO5693088A
`[11] Patent Number:
`[45] Date of Patent:
`
`5,693,088
`Dec. 2, 1997
`
`[54] INTRALUNIINAL VASCULAR GRAFT
`
`[76] Inventor: Harrison M. Lazarus, 853 Thirteenth
`Ave" Salt Lake C‘ty’ Utah 84103
`
`[21] Appl. No.2 485,004
`[22] Filed:
`Jun. 7, 1995
`
`Related [15- Application Data
`_
`_
`_
`[63] cml'muauonim'pm °f Sen N°- 149,040’ N9“ 3’ 1993’
`abandoned'
`[51] Int. GL6 ............................ .. A61F 2/06; A61M 29/00
`[52] US. Cl. ............ ..
`623/1; 623/12; 606/195
`[58] Field Of Search .................................. .. 623/1, 11, 12;
`606/194, 195’ 151, 152’ 153, 191’ 196’
`197, 198; 600/36
`
`[56]
`
`References Cited
`
`U-S- Pm DOCUMENTS
`6/1974 Goldberg .............................. .. 606/153
`3,818,511
`4,140’126 2/1979 Choudhury ,
`4,355,426 10/1982 MacGregor .
`4,562,596
`1/1986 Kornberg .
`4,577,631
`3/1986 Kreamer -
`4,517,932 10/1936 Kornberg -
`4,776,337 10/1983 Palmaz -
`'
`9/1992 Kwan-Gett.
`2/1994 Gdanturco .
`
`5,151,105
`5,282,824
`
`5,376,118 12/1994 Kaplan et al. .......................... .. 623/11
`5,397,345
`3/1995 Lazarus.
`5,405,379
`4/1995 Lane -
`Primary Examiner-Debra s. Brittingham
`Attomey, Agent, or Firm-Trask, Britt & Rossa
`[57]
`ABSTRACT
`
`An intraluminal vascular graft is structure to be deployable
`Within a vessel for incorporation therein without use of
`hooks or barbs. The intraluminal vascular graft structure
`comprises a tubular body formed of a biocompatible mate
`rial and a frame structure, having both circumferential
`support and longitudinal support structures, which support
`the graft at a distal end thereof and upwardly from the distal
`end- The vascular graft also includes a porous collar which
`have suf?cient porosity to promote and enhance ingrowth of
`tissue and other materials into the ‘porous collar from the
`surrounding vessel environment, thereby facilitating incor
`poration of the intraluminal vascular graft into the vessel
`wall. The tubular body of the intraluminal vascular graft
`may include one or more leg portions suitable for repairing
`bifurcfitcd Vessels which, in Conjunction with the circum
`ferentral and longitudinal support structures, and the porous
`collar, assure positioning and support of the vascular graft
`Within the vessel and against the crotch of the bifurcation.
`The inlraluminal vascular graft is designed to form a tight
`seal between the graft and inner vessel Wall, especially at the
`upstream end of the graft, to prevent perigraft leakage and
`formation of pseudoaneurysrns around the graft.
`
`22 Claims, 5 Drawing Sheets
`
`Edwards Lifesciences Corporation, et al. Exhibit 1147, Page 1 of 18
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`

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`US. Patent
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`Dec. 2, 1997
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`Sheet 1 of 5
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`5,693,088
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`Fig. 2
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`Edwards Lifesciences Corporation, et al. Exhibit 1147, Page 2 of 18
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`US. Patent
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`Dec. 2, 1997
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`Sheet 2 of 5
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`5,693,088
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`Fig. 4
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`Edwards Lifesciences Corporation, et al. Exhibit 1147, Page 3 of 18
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`US. Patent
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`Dec. 2, 1997
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`Sheet 3 of 5
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`5,693,088
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`Fig. 5
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`Edwards Lifesciences Corporation, et al. Exhibit 1147, Page 4 of 18
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`U.8. Patent
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`Dec. 2, 1997
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`Sheet 4 of 5
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`5,693,088
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`112
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`Edwards Lifesciences Corporation, et 31. Exhibit 1147, Page 5 of 18
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`Edwards Lifesciences Corporation, et al. Exhibit 1147, Page 5 of 18
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`US. Patent
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`Dec. 2, 1997
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`Sheet 5 of 5
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`5,693,088
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`Edwards Lifesciences Corporation, et al. Exhibit 1147, Page 6 of 18
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`5,693,088
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`1
`INTRALUMINAL VASCULAR GRAFT
`
`RELATED APPLICATIONS
`
`This application is a continuation-in-part of Ser. N 0.
`149,040, ?led Nov. 8, 1993, now abandoned the contents of
`which are incorporated herein by reference.
`
`2
`sac, because gaps form between the graft and the inner wall
`of the vessel, usually at the upstream end of the graft device.
`Most failures of vascular grafts are due to leakage, and the
`patient’s condition is compromised. Devices have been
`5 described in the literature which address, to some extent, the
`problem of leakage around the graft device. Examples of
`such devices are described in U.S. Pat. No. 5,282,824 to
`Gianturco and U.S. Pat. No. 5,405,379 to Lane. However,
`such devices do not assure a tight seal between the graft and
`the vessel wall while meeting the other necessary charac
`teristics of a vascular graft suitable for implantation in badly
`damaged vessels, or vessels which have an unusual mor
`phology.
`Thus, it would be advantageous to provide an intraluminal
`graft which is adapted for use in vascular repair under any
`conditions, but par1icularly under conditions which limit or
`prevent the use of intraluminal grafts having hook, pin, barb
`or staple attachment means. Further, it would be advanta
`geous to provide an intraluminal graft which is structured to
`be easily implanted, even under conditions of severe vas
`cular damage and/or aberrant morphology, and which is
`incorporated into the internal vessel wall to assure a com
`plete seal between the extreme ends of the graft and the
`vessel wall thereby preventing leakage.
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`DISCLOSURE OF THE INVENTION
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`BACKGROUND OF THE INVENTION
`1. Technical Field
`This invention relates to medical devices in general, and
`speci?cally to grafts positionable intraluminally for repair
`' ing aneurysms or other vascular defects in humans and
`annuals.
`2. Background
`Aneurysms are caused by weakening of a vessel wall
`which results in the outward ballooning of the wall under the
`pressure of ?owing blood. Aneurysms are more prevalent in
`men than in women, and are more common with advancing
`age. Prior to the development of technology to repair the
`bulging blood vessel, aneurysms posed a fatal threat to those
`who developed them. Even with the early development of
`repair procedures, signi?cantly invasive surgery was
`required to access the aneurysm. Today, graft structures have
`been developed which allow insertion and delivery of the
`graft to the point of the aneurysm using less invasive
`procedures.
`Known intraluminal graft structures generally comprise a
`tubular graft, expansion means for deploying and position
`ing the graft in the vessel and anchoring or attachment
`means for keeping the graft in place within the vessel. Many
`varying types of expansion means have been disclosed,
`including those described in U.S. Pat. No. 4,140,126 to
`Choudhury; U.S. Pat. No. 4,776,337 to Palrnaz; U.S. Pat.
`No. 5,123,917 to Lee; and U.S. Pat. No. 5,151,105 to
`KWan-Gett. Means have also been described for providing
`longitudinal support to the graft, including those means
`described in U.S. Pat. No. 4,562,596 to Kornberg and U.S.
`Pat. No. 5,151,105 to Kwan-Gett.
`Additionally, various means for attaching the graft to the
`vessel have been disclosed. Most frequently, hook, barb or
`pin means are described and used, including the means
`described in U.S. Pat. No. 4,140,126 to Choudhury; U.S.
`Pat. N 0. 4,562,596 to Kornberg; and U.S. Pat. No. 5,151,105
`to Kwan-Gett. In some instances, the hook or barb means are
`attached to the expandable means as described in U.S. Pat.
`No. 4,140,126 to Choudhury and U.S. Pat No. 5,104,399 to
`Lazarus. U.S. Pat. No. 4,577,631 to Kreamer discloses use
`of an adhesive covering the entire outside of the graft to
`provide adherence of the luminal intima to the graft.
`The most commonly used intraluminal graft structures
`have hooks or barbs which pierce into or through the wall of
`the vessel to anchor the graft to the vessel above the
`aneurysm. That is, most, if not all, currently described
`intraluminal grafts are supported in the vessel upstream from
`or above the disease condition. However, hooks or barbs
`may damage the vessel, particularly where the vessel is
`weakened already by an aneurysm or other disease condi
`tion. Additionally, there are instances when the condition of
`the vessel may make it impossible or imprudent to use a
`graft device having hooks or pins, such as the existence of
`calcium deposits. Such conditions may also limit the use
`fulness of adhesives.
`A further problem encountered with graft devices cur
`rently in use is the leakage of blood around the upstream end
`of the graft. Leakage occurs, and blood ?lls the aneurysmal
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`In accordance with the present invention, an intraluminal
`vascular graft is structured to facilitate incorporation of at
`least a portion of the graft into the internal vessel wall of a
`damaged or aneurysmal vessel, either at the extremities of
`the graft or along a substantial portion of the graft, to prevent
`leakage of blood around the graft and into the damaged
`portion of the vessel. The intraluminal vascular graft is
`further structured to be radially expandable to engage the
`inner wall of the vessel upon deployment and to be sup
`ported within the vessel from a position downstream from,
`or below, a disease condition existing in the vessel. The
`intraluminal vascular graft is structured to be ?exible along
`the longitudinal axis of the graft to facilitate deployment
`through non-linear vessels and to render the graft suitable
`for implantation in vessels which are non-linear. While the
`intraluminal vascular graft of the invention may be used in
`any number of various vascular repairs, it is particularly
`suitable in the repair of aneurysms of the abdominal aorta,
`which is one of the most common types of aneurysm.
`The intraluminal graft of the present invention generally
`comprises a biocompatible tube, a radially expandable frame
`attached to the biocompatible tube, ?exible longitudinal
`support structure to position the graft within the vessel and
`to provide support for the biocompatible tube and non
`puncttn-ing attachment means for incorporating the graft into
`the internal wall of the vessel in a manner to prevent
`perigraft leakage. As used herein, perigraft leakage means
`?ow or leakage of blood between the graft and the internal
`wall of the vessel such that blood ?lls the aneurysmal sac
`surrounding the graft.
`'
`The biocompatible tube of the present invention is
`capable of being compressed to provide a graft having a
`reduced circumferential dimension to permit insertion of the
`graft into a vessel (e.g., femoral artery) for transportation to
`the disease site of a vessel. The tube is thereafter capable of
`expanding radially outwardly from a central longitudinal
`axis to provide a dose ?t between the tube structure and the
`inner vessel wall. The tube has at least two open ends- one
`which may be termed a proximal end, and one which may
`be termed a distal end. As used herein, “proximal” refers to
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`the end of the graft which is positioned upstream, or which
`is oriented toward the cranium of the patient. As used herein,
`“distal” refers to the end of the graft which is positioned
`downstream, or which is oriented toward the caudal end of
`the patient The tube may be made of any suitable biocom
`patible material or materials, including polyester (e.g.,
`Dacron®) and polytetra?uoroethylene.
`When used in vessels which bifurcate, such as the
`abdominal aorta, the tube may include leg portions which
`extend into one or more branching vessels resulting from the
`bifurcation. The tube may have a single leg portion extend
`able into a single branching vessel. More suitably, however,
`the tube has two leg portions extendable into both branching
`vessels. The relative lengths of the two leg portions may be
`equal, or one may be longer than the other as dictated by the
`particular condition of the vessel. The leg portions facilitate
`positioning and support of the device in bifurcated vessels
`by providing a crotch area between the two leg portions
`which straddles the crotch or cusp between the branching
`vessels of the bifurcation.
`In an alternative embodiment, the tube may have a single
`leg portion with a hole formed in the tube opposite the leg
`portion to allow ?uid ?ow into the other branching vessel.
`In another alternative embodiment, the tube may have a
`single leg portion with no corresponding opening in oppos
`ing position, or the tube may have a ?rst leg portion and a
`second leg portion, the shorter leg portion having no opening
`therein to allow blood ?ow therethrough. An intraluminal
`vascular graft of such construction would be useful in
`repairing bifurcated vessels (such an iliac artery) where the
`surgeon speci?cally desires to restrict blood ?ow to a single
`branching vessel of the bifurcation.
`The tube of the intraluminal vascular graft may also
`comprise a single tube, having no extending leg portions,
`which is suitable for repairing less complex vessel structures
`or disease conditions. In a single tube con?guration, the
`intraluminal vascular graft includes only a proximal open
`end and a distal open end to allow movement of blood
`through the graft.
`The intraluminal vascular graft further includes expand
`able circumferential support structures which, immediately
`upon deployment of the graft, radially expand to the full
`inner circumferential dimension of the vessel to be repaired.
`Radial expansion of the circumferential support structures
`positions the tubular graft securely against the internal wall
`of the vessel upon deployment. The expandable circumfer
`ential support structures are secured at the proximal end of
`the tube and at the distal end of the tube. The expandable
`circumferential support structure positioned at the distal end
`of the graft tube, also referred to herein as the expandable
`caudal support, provides a means for positioning the graft
`tube within the vessel and for supporting the graft within the
`vessel at a point distal, or downstream, to the disease
`condition. In bifurcated vessels, the expandable caudal sup
`port is particularly structured to provide support and seating
`of the graft tube at the point where the vessel bifurcates, or
`on what is otherwise termed the cusp of the bifurcation.
`Circumferential support structures may also be secured to
`the terminal ends of the leg portions when the graft is
`constructed with extending leg potions. The circumferential
`support structures thus assure positioning of the leg portions
`against the inner wall of the branching vessels into which the
`leg portions extend, and anchor the leg portions thereagainst.
`Placement of the circumferential support structures at the
`proximal end and distal end of the tube render the graft
`suitable for placement in a vessel which is non-linear. In
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`4
`other words, while most vessels tend to be substantially
`straight, or only slightly curved, other vessels may bend or
`kink due to aberrant morphology of the vessel or to posi
`tioning of the vessel in proximity to other organs. Such
`vessels may have as much as a ninety-degree angle of
`curvature. Diseases or aneurysms which occur in such
`vessels present a unique’ challenge to repair techniques. The
`present invention is particularly constructed to accommo
`date the repair of vessels under those unique circumstances
`by being longitudinally ?exible and capable of bending to
`meet the angle of the vessel.
`The expandable circumferential support structures may be
`constructed of any material, or may take any form, which
`provides the ability of reducing the circumferential dimen
`sion of the circumferential support structures prior to
`deployment of the intraluminal graft, and which allows the
`structures to expand once the graft is deployed. The expand
`able circumferential support structures may preferably be
`instantaneously self-expanding, and to that end may be
`formed, for example, as a tensioned ring of ?exible material
`which unwinds or decompresses upon release of a compres
`sion force surrounding the circumferential support struc
`tures. Alternatively, the expandable circumferential support
`structures may be expandable by unrelated means, such as
`by an in?atable angioplasty balloon introduced following
`insertion of the graft.
`The intraluminal vascular graft also includes at least two
`adjustable longitudinal support structures oriented along the
`length of the biocompatible tube and positioned at an angle
`to the expandable circumferential support structures. The
`angle between the longitudinal support structures and the
`circumferential support structures may be anywhere from
`about sixty to about one hundred and twenty degrees, but
`may preferentially be substantially perpendicular to each
`other. The longitudinal support structures maintain the tube
`in its full, predetermined length following deployment
`within the vessel, and prevent collapse of the tube upon
`itself. By “predetermined” is meant that the length of the
`longitudinal support structures and graft tube which is
`required to repair the vessel may be determined by known
`x-ray or ?uoroscopic techniques, and prior to insertion, the
`surgeon may select a graft of appropriate dimension or may
`modify or adjust the longitudinal support structures and graft
`tube to ?t the vessel. The longitudinal support structures
`support the graft longitudinally within the vessel and act in
`tandem with the expandable caudal support to support the
`graft in the vessel from the distal end of the graft upward.
`The longitudinal support structures also maintain the graft
`in place and function to keep the graft from moving back and
`forth longitudinally within the vessel. The longitudinal sup
`port structures facilitate prevention of migration of the graft
`within the vessel. Orientation and anchoring of the graft
`within the vessel is facilitated by longitudinal support struc4
`tures extending beyond the proximal or upstream end of the
`biocompatible tube. The longitudinal support structures are
`most suitably ?exible so that ?rey may bend in a direction
`transverse the longitudinal axis of the tube, such as may be
`necessary when the graft is deployed in a vessel which bends
`along its course as previously described. The longitudinal
`support structures, in an alternative embodiment, may be
`further adjustable after the graft is placed within the vessel.
`Such adjustability may be provided, for example, by use of
`longitudinal support structures having telescoping members.
`The expandable circumferential support structures and the
`adjustable longitudinal structures generally comprise what
`may be called the frame of the graft structure. The frame is
`secured to the biocompatible graft tube by any suitable
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`means, such as tacking or sewing the frame to the tube, or
`by weaving the frame into the tube. The frame may be
`positioned within the graft tube material so that the frame is
`exposed to ?uid moving through the graft tube.
`Alternatively, and more suitably, the frame is disposed on
`the outer surface of the graft tube material and is, therefore,
`positioned between the inner vessel wall and the outer
`surface of the graft tube.
`To facilitate placement of the graft within the vessel, some
`portion of the frame may be treated with radio-opaque
`materials which are detectable by ?uoroscopic or other
`appropriate methods. Most suitably, at least one of the
`longitudinal structures may be treated with radio-opaque
`materials to detect correct positioning and correct twisting of
`the intraluminal vascular graft upon deployment within the
`vessel.
`Fixed attachment of the graft tube to the interior of the
`vessel, or the intima, is provided by non-puncturing attach
`ment means secured to the outer surface of the biocompat
`ible tube. The attachment means extend about, or encircle,
`the full outer circumference of the tube at the proximal or
`upstream end of the tube to provide complete Contact
`between the intraluminal vascular graft and the circumfer
`ence of the inner surface of the vessel positioned proximate
`the attachment means. Complete contact between the attach
`ment means and the inner circumferential surface of the
`vessel at the upstream end prevents perigraft leakage.
`Attachment means may also be positioned at or, near the
`distal end of the graft tube to enhance incorporation of the
`graft into the vessel.
`The attachment means is made of a ?exible material
`which renders it suitable for compression prior to deploy
`ment and expandable again upon deployment to extend to
`the full circumferential dimension of the inner surface of the
`vessel. The material of the attachment means is formed from
`material which is, or is otherwise treated to be, porous and/or
`textured to promote the attachment or ingrowth of tissue into
`the attachment means thereby incorporating at least a por
`tion of the intraluminal vascular graft into the vessel.
`When reference is made herein to “ingrowth of tissue and
`other matter” it should be noted that the internal environ
`ment of a damaged vessel may present a variety of tissue and
`other cellular matter, including vascular tissue, fibroblasts,
`clotted blood, platelets and other deposited matter. The
`attachment means of the present invention are designed to
`encourage the ?lling of the pores in the material of the
`attachment means with either tissue or other cellular mate
`rial from the surrounding environment to form a mechanical
`securement with the attachment means. Eventually, some
`vascularized tissue, as well as scar tissue, will form in and
`about the attachment means to fully incorporate the graft
`into the damaged vessel.
`The attachment means may be made of a material which
`has inherent porosity, such as polypropylene, polyurethane,
`latex or other suitable material, or combinations of material,
`which renders at least the surface of the attachment means
`suitable for ingrowth of tissue and matter. As used herein
`“porous” means that openings are formed on at least the
`surface of the material facing outwardly toward the interior
`of the vessel. As such, “porous” may include materials
`which have dimples or depressions positioned on the surface
`thereof, closed-cell pores which extend partially through the
`thickness of the material, open-cell pores which form a
`channel through the thickness of the material, and both
`regularly- and irregularly-shaped and sized pores. The
`attachment means may thus be formed from material having
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`the requisite porosity to enhance ingrowth of matter, or the
`attachment means may be formed from a material lacking
`porosity which is then coated or treated with a material
`providing the surface with the requisite porosity (e. g., metal
`coated with latex).
`The attachment means may also be treated, such as by
`coating or infusion, with a substance or material which
`promotes attachment of the vessel to the graft. Such sub
`stances may promote healing or ingrowth of tissue into the
`attachment means and may include, for example, ?brinogen
`or plasma treated in absence of ammonia. The attachment
`means may also include, or be treated with, a radio-opaque
`material in the manner described previously to facilitate
`deployment and correct positioning of the intraluminal vas
`cular graft within the vessel.
`The attachment means of the present invention may, in a
`?rst embodiment, comprise a collar of material which sur
`rounds the entire circumference of certain portions of the
`biocompatible tube. At a minimum, a ?rst collar having
`porosity and texture su?icient to promote ingrowth of tissue
`and matter is positioned about the proximal, or upstream,
`end of the intraluminal vascular graft to assure incorporation
`of the graft into the surrounding vessel thereby preventing
`perigraft leakage. A second collar having porosity and
`texture may be positioned about the distal, or downstream,
`end of the intraluminal vascular graft to facilitate complete
`attachment of the device to the vessel. Additionally, a collar
`of the described material may be positioned about each leg
`of the tube when the biocompatible tube is con?gured with
`one or more leg portions. The collars may suitably be
`positioned proximate the expandable circumferential sup
`port structures so that upon deployment of the intraluminal
`vascular graft the radially expanding circumferential support
`structures urge the collars of the attachment means securely
`against the inner surface of the vessel. The collars may,
`however, be positioned at some distance from ?re frame
`structures as may be dictated by the particular conditions of
`deployment or vascular repair.
`In an alternative embodiment, the attachment means may
`be a toroidal collar having an internal in?atable space which
`facilitates expansion of the intraluminal vascular graft to
`contact the inner surface of the vessel. The use of a toroidal
`collar as attachment means may be particularly suitable in
`diseased vessels where the vessel wall is signi?cantly
`stretched and/or distended as compared to the normal shape
`or patency of the vessel. The ability of the toroidal collar to
`enlarge, and thus expand outwardly from the surface of the
`biocompatible tube to contact the vessel, enables the intralu
`minal vascular graft to adjust to the unique internal dimen
`sion or shape of the vessel and to encourage ingrowth of
`tissue into the attachment means. In other words, the toroidal
`collar presents an anisotropic wall oriented toward the
`interior of the vessel. At a minimum, a toroidal collar is
`positioned about the proximal end of the biocompatible
`tube. However, additional toroidal collars may be positioned
`about the distal end of the tube and/or about the extremity of
`each leg portion in embodiments con?gured with leg por
`tions.
`In yet another embodiment, the attachment means may
`comprise a toroidal encasement member having an internal '
`and in?atable space. The toroidal encasement member
`extends from proximate the proximal end of the biocompat
`ible tube to the distal end of the tube, and is positioned on
`the outer surface of the tube, between the biocompatible tube
`and the inner circumference of the vessel. The internal and
`enlargeable space of the toroidal encasement member allows
`the attachment means to extend outwardly from the biocom
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`patible tube and to contact the inner surface of the vessel.
`This embodiment is particularly suitable for use in diseased
`vessels where the vessel wall is stretched and/or distended
`because the toroidal encasement member can expand to
`contact the inner surface of the vessel and thereby encourage
`incorporation of the entire vessel into the entire length of the
`graft between the proximal end and distal end of the vascular
`graft.
`The toroidal collar or toroidal encasement member may
`be made of any suitable biocompatible material which
`encourages ingrowth of tissue and other matter into the
`attachment means, including, for example, polyurethane.
`The toroidal or toroidal encasement member may be formed
`from an inherently porous material or may be made of a
`non-porous material treated to render the surface porous and
`textured to facilitate ingrowth of tissue thereinto.
`The toroidal collars or toroidal encasement member are
`enlarged or in?ated following deployment of the graft in the
`vessel. A conduit is connected to each toroidal collar or to
`the toroidal encasement member through which ?uid may be
`introduced into the internal space of each toroid. The conduit
`connected to each toroidal collar or toroidal encasement
`member extends from the attachment means to outside the
`patient’s body where ?ow of ?uid through the conduit and
`into the toroidal collar or toroidal encasement member may
`be controlled. Any suitable ?uid may be introduced into the
`internal space of the attachment means, be it liquid or gas,
`but saline solution is particularly suitable. Once the toroidal
`collars or toroidal encasement member is enlarged to the
`desired degree, the conduit is detached from the attachment
`means, whereupon a valve means is caused to close and seal
`off the internal space of the attachment means. The pressure
`of the enlarged toroidal collar or toroidal encasement mem
`ber must not exceed the mean arterial blood pressure
`(MABP) in order to avoid rupture. Yet, when deployed in the
`aorta, the pressure of the enlarged toroidal collar or toroidal
`encasement member must be greater thanthat of the lumbar
`arteries which apply pressure to the aorta. If deployed in a
`vessel having a non-linear pro?le, it is preferable that the
`toroidal encasement member be sufficiently de?ated to per
`mit the intraluminal vascular device to curve or bend in
`conformance with the shape of the vessel.
`To further attach the intraluminal vascular graft to the
`vessel, the biocompatible tube may be coated or otherwise
`treated with a material or substance which induces an
`in?ammatory response, such as polylactic acids, polygly
`colic acids or polyamino acids. The graft tube may also be
`constructed or treated in a manner which encourages
`ingrowth of tissue on to the graft tube to enhance or promote
`incorporation of the tube into the surrounding vascular
`environment, along with the attachment means. Such treat
`ment may include coating or infusing the tube material with
`collagen, for example.
`Also, the longitudinal and/or circumferential support
`structures may be constructed of a material which inherently
`causes an in?ammatory response and/or which is con
`structed of a material which promotes ingrowth of tissue into
`the support structure. The longitudinal and/or circumferen
`tial support structures may also be treated, such as by
`coating with collagen, polylactic acids, polyglycolic acids or
`polyamino acids to promote ingrowth of the device into the
`surrounding vascular tissue.
`The intraluminal graft is delivered to the site of the
`diseased vessel by transport means which are sized and
`structured to contain the intraluminal graft therein or
`thereabout, and which facilitate insertion of the device
`
`8
`through the arterial system A particularly suitable transport
`means comprises a capsule within which the intraluminal
`graft is retained in a collapsed condition, and deployment
`means for releasing the intraluminal graft from the capsule
`and positioning it within the vessel.
`The capsule is ?exibly structured to navigate smoothly
`through the tortuous pathway that can often be encountered
`in the arterial tree. The capsule and associated deployment
`structures, described hereafter, are inserted into a small
`incision made in an artery or vein located remotely from the
`area of diseased vessel. With respect to aortic aneurysms, for
`example, the capsule is inserted into a femoral artery and
`passed upwardly to the abdominal aorta. A guide wire may
`be used initially to determine proper placement. The capsule
`containing the graft may then be threaded about or over the
`guide wire to the point of deployment.
`When the capsule has reached the disease site, a deploy
`ment structure deploys the device within the vessel. Expan
`sion actuator means may be included if necessary, such as an
`angioplasty balloon, to facilitate expansion of the device.
`Alternatively, the deployment structure may be structured
`with expansion actuator means to both deploy and facilitate
`expansion of the graft. Exemplar deployment means include
`a hydraulic force.
`In a ?rst suitable implantation method, the capsule con
`taining the compressed graft is inserted into the diseased
`vessel. A guide wire may be used to insert the capsule. Once
`positioned at the site of deployment, a positioning means
`maintains the graft in place while the capsule is withdrawn
`from the vessel. Alternatively, the capsule may be removed
`from about the graft structure, such as when the capsule is
`in the form of a tear-away sheath. The graft may be assisted
`in deployment from the capsule by means of a stabilizer rod
`which is manipulable from outside the patient’s body.
`An angioplasty balloon may be used, if necessary, to assist
`in deploying and expanding the graft. Alternatively, the graft
`may be deployed from the capsule by application of a
`hydraulic force provided by infusion of saline solution.
`Once the graft is released from the capsule, the compressive
`forces which kept the frame o