United States Patent [i9]
`Lau et al.
`
`[54]
`
`[75]
`
`METHOD AND SYSTEM FOR STENT
`DELIVERY
`Inventors:
`
`[73] Assignee:
`
`[21] Appl. No.:
`[22]
`Filed;
`
`Lilip Lau, Cupertino; William M.
`Hartigan, Fremont, both of Calif.
`Advanced Cardiovascular Systems,
`Inc., Santa Clara, Calif.
`735,195
`Jul. 24, 1991
`Related U.S. Application Data
`Continuation of Ser. No. 514,108, Apr. 25, 1990, aban­
`doned.
`Int. C1.5...........
`U.S. a.............
`Field of Search
`
`[63]
`
`[51]
`[52]
`[58]
`
`[56]
`
`.............A61M 29/00
`...... 604/96; 604/164
` 604/164-167,
`...........
`604/96-104, 280, 282
`References Cited
`U.S. PATENT DOCUMENTS
`Alfidi et al.........
`3/1975
`3,868,956
`Simpson et al. ...
`5/1990
`4,323,071
`Lundquisl .........
`4,332,254
`6/1982
`Lundquist .........
`4.439.185
`3/1984
`Enzmann et al. .
`4,468,224
`8/1984
`Balko et al.........
`4,512,338
`4/1985
`Samson ............
`4,516,972
`5/1985
`Samson et al......
`4,538,622
`9/1985
`Maass et al.........
`4.553,545
`11/1985
`Samson et al.......
`4,554,929
`11/1985
`Frisbie .............
`4,569,347
`2/1986
`Samson et al......
`2/1986
`4,571,240
`Gould et al........
`4.572.186
`2/1986
`Simpson ............
`4,616,652
`10/1986
`Wallsten ...........
`4,655,771
`4/1987
`Wholey et al......
`2/1988
`4,723,549
`
`604/96 X
`604/96 X
`604/96 X
`... 604/97
`...... 604/96 X
`...... 604/282
`.... 604/170 X
`....... 604/104
`..... 604/95 X
`.... 604/164 X
`.......... 604/96
`.... 604/104 X
`.... 604/280 X
`.... 604/281 X
`.... 604/101 X
`
`h-2
`
`US005158548A
`[11] Patent Number:
`[45] Date of Patent:
`
`5,158,548
`Oct. 27, 1992
`
`..... 604/96 X
`4,733,665 3/1988 Paimaz .................
`..... 604/96 X
`4,739,762 4/1988 Palmaz .................
`... 604/102 X
`4,748,982 6/1988 Horzewski et al.....
`... 604/170 X
`4,748,986 6/1988 Morrison et al.......
`..... 604/96 X
`4,762,128 8/1988 Rosenbluth ..........
`4,790,315 12/1988 Mueller, Jr. et al. .
`604/104 X
`4,848,342 7/1989 Kaltenbach ..........
`FOREIGN PATENT DOCUMENTS
`183372 10/1985 European Pat. OfT. .
`57-89859 6/1982 Japan .
`Primary Examiner—John D. Yasko
`ABSTRACT
`[57]
`A stent delivery system having an expandable stent in a
`contracted condition positioned on an expandable mem­
`ber, such as an inflatable balloon, disposed on the distal
`portion of an elongated catheter body. A guidewire
`extends through an inner lumen within the elongated
`catheter body and out its distal end. A tubular protec­
`tive sheath is secured by its distal end to the portion of
`the guidewire which extends out of the distal end of the
`catheter body and fits over the rolled up stent mounted
`on the expandable member on the distal end of the
`catheter body. The catheter assembly is advanced to a
`desired location within a patient’s body lumen, such as
`the patient’s arterial system, with the sheath in place
`over the stent. Once in proper position, the guidewire is
`advanced distally in order to remove the attached
`sheath and completely expose the stent. The expandable
`member on the catheter is expanded to expand the stent.
`The stent is preferably self-locking in the expanded
`condition so that the expanded expandable member can
`be contracted and the catheter can be removed there­
`from.
`
`15 Claims, 6 Drawing Sheets
`
`22a
`
`See
`
`IIt
`
`to
`
`20
`
`■24
`
`23
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1029 - Page 1
`
`

`

`U.S. Patent
`
`Oct. 27, 1992
`
`Sheet 1 of 6
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1029 - Page 2
`
`

`

`U.S. Patent
`U.S. Patent
`
`Sheet 2 of 6
`
`Oct. 27, 1992
`
`5,158,548
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1029 - Page 3
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1029 - Page 3
`
`

`

`U.S. Patent
`
`Oct. 27, 1992
`
`Sheet 3 of 6
`
`5,158,548
`
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1029 - Page 4
`
`

`

`U.S. Patent
`
`Oct. 27, 1992
`
`Sheet 4 of 6
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`5,158,548
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1029 - Page 5
`
`

`

`U.S. Patent
`
`Sheet 5 of 6
`
`5.158,548
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1029 - Page 6
`
`

`

`U.S. Patent
`
`Oct. 27, 1992
`
`Sheet 6 of 6
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`5,158,548
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1029 - Page 7
`
`

`

`5
`
`10
`
`15
`
`20
`
`1
`METHOD AND SYSTEM FOR STENT DELIVERY
`This is a continuation of the U.S. patent application
`Ser. No. 07/514,108 which was filed on Apr. 25, 1990
`now abandoned.
`BACKGROUND OF INVENTION
`This invention is related to the delivery of expandable
`devices commonly called “stents” within a body lumen
`such as an artery and the expansion of the stent therein
`to maintain the patency of the body lumen. The inven­
`tion is particularly suitable for the delivery of stents
`after angioplasty procedures.
`Percutaneous transluminal coronary angioplasty
`(PTCA) is now a widely practiced procedure for treat­
`ing coronary artery disease. In a typical PTCA proce­
`dure, a dilatation catheter having an inflatable, rela­
`tively inelastic balloon on the distal end thereof is ad­
`vanced through a patient’s arterial system until the
`deflated balloon crosses an atherosclerotic lesion to be
`dilated. The balloon is inflated to a predetermined size
`with radiopaque liquid at relatively high pressures (e.g.
`up to 8 atmospheres or more) to compress the athero­
`sclerotic plaque and to dilate the artery in the stenotic
`region. After dilation the balloon is then deflated so that
`the catheter can be removed. Due to the enlarged arte­
`rial passageway, increased blood flow results.
`In typical PCTA procedures, a guiding catheter hav­
`ing a performed distal end is first percutaneously intro­
`duced into the patient’s arterial system and advanced
`until the distal tip of the catheter is disposed in the
`ostium of a coronary artery. A guidewire is slidably
`disposed within an inner lumen of a dilatation catheter
`and both are advanced through the guiding catheter to
`the distal end thereof. The guidewire is first advanced
`out of the distal tip of the guiding catheter into the
`patient’s coronary anatomy until the distal end of the
`guidewire crosses the lesion to be dilated. The physician
`usually shapes the distal end of the guidewire to facili­
`tate steering it through the patient’s tortuous coronary
`arteries. Once the guidewire is in place, the dilatation
`catheter is then advanced out of the distal tip of the
`guiding catheter over the guidewire until the deflated 45
`balloon on the distal end of the dilatation catheter is
`positioned across the lesion. The balloon is inflated to a
`suitable pressure to dilate the stenosis, deflated, and
`then removed from the patient’s vasculature.
`For a more detailed description of the angioplasty 50
`procedures and the devices used in such procedures,
`reference is made to U.S. Pat. No. 4,332,254 (Lund-
`quist); U.S. Pat. No. 4,323,071 (Simpson-Robert); U.S.
`Pat. No. 4,439,185 (Lundquist); U.S. Pat. No. 4,468,224
`(Enzmann et al.); U.S. Pat. No. 4,516,972 (Samson); 55
`U.S. Pat. No. 4,538,622 (Samson et al.); U.S. Pat. No.
`4,554,929 (Samson et al); U.S. Pat. No. 4,569,347 (Fris-
`bie); U.S. Pat. No. 4,571,240 (Samson et al); U.S. Pat.
`No. 4,616,652 (Simpson) and U.S. Pat. No. 4,748,982
`(Horzewski et al) which are hereby incorporated in 60
`their entirety by reference thereto.
`On occasions the inflation of the balloon during angi­
`oplasty causes a dissection in the arterial lining, e.g. the
`stenotic plaque or the arterial intima. When the balloon
`is deflated after such a dilation, blood can flow between 65
`the arterial wall and the dissected lining constricting the
`flow passage therein or causing a section of the dis­
`sected lining, commonly called a “flap,” to be forced
`
`5,158,548
`2
`into the flow passageway thereby partially or com­
`pletely blocking the blood flow through the artery.
`Several methods have been proposed to resecure a
`dissected lining to the artery wall. For example, the
`dilatation catheter can be removed after the angioplasty
`procedure has been performed and replaced with a
`catheter having an expandable member at the distal end
`which allows for the perfusion of blood through the
`expandable member when expanded. In this method,
`the expanded member presses the dissected tissue lining
`against the arterial wall for an extended period until
`natural healing can result in the resecuring of the dis­
`sected lining to the arterial wall. Blood perfuses
`through the expanded member so that ischemic condi­
`tions are minimized or eliminated distal to the expanded
`member. However, these lining repair procedures usu­
`ally require leaving the catheter with the expanded
`member in place for an extended period, e.g., several
`hours or more, in order to ensure that the lining has
`been properly resecured to the arterial lining. Suitable
`catheters for this purpose are disclosed in U.S. Pat. No.
`4,790,315 and copending U.S. patent application Ser.
`No. 283,729 filed Dec. 13, 1988, U.S. patent application
`Ser. No. 404,815 filed Sep. 8, 1989, and U.S. patent
`application Ser. No. 404,818 filed Sep. 8, 1989, each of
`which are incorporated herein in their entirety by refer­
`ence thereto.
`Much development work has also been recently per­
`formed on the utilization of expandable stents in situa­
`tions where long term expansion in an arterial or other
`bodily lumen is desired, such as in the instances de­
`scribed above. Expandable stents and their method of
`use are described in U.S. Pat. No. 3,868,956, (Alfidi et
`al); U.S. Pat. No. 4,512,338 (Balko et al); U.S. Pat. No.
`4,553,545 (Maass et al); U.S. Pat. No. 4,655,771 (Walls-
`ten); U.S. Pat. No. 4,733,665 (Palmaz); U.S. Pat. No.
`4,739,762 (Palmaz); U.S. Pat. No. 4,762,128 (Rosen-
`bluth), Japanese application 57-89859 published Jun. 4,
`1982, and European Application 0183372 published Jun.
`9, 1986 which are hereby incorporated herein by refer­
`ence thereto. While this development work has been
`promising, no reliable and easily usable system has yet
`been developed which allows for the delivering an
`expandable stent to a desired location within a body
`lumen, particularly the coronary arteries, fixing the
`stent in an expanded condition within the bodily lumen
`and then removing the delivery system leaving the
`expanded stent in place. The present invention satisfies
`the need for such a stent delivery system.
`SUMMARY OF THE INVENTION
`This invention is directed to an expandable stent de­
`livery system, which is particularly suitable for use in
`coronary arteries.
`The stent delivery system of the present invention
`includes an elongated catheter body having an expand­
`able member such as an inflatable balloon on the distal
`portion thereof with a constricted expandable stent
`mounted on the expandable member. A guidewire ex­
`tends through an inner lumen of the catheter body and
`out an axial opening in the distal end of the catheter. A
`tubular protective sheath is fixed by its distal end to a
`portion of the guidewire which extends out of the distal
`end of the catheter body. In one embodiment of the
`invention, the tubular protective sheath is self support­
`ing and has an inner diameter which is sufficiently large
`so that the sheath can easily slide over the constricted
`stent when mounted onto and removed from the ex-
`
`25
`
`30
`
`35
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1029 - Page 8
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`

`

`5
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`10
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`15
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`
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`5,158,548
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`3
`pandable member on the distal end of the catheter body.
`FIG. 2 is a transverse cross-sectional view taken
`In an alternative embodiment of the invention, the
`along the lines 2—2 shown in FIG. 1;
`FiG. 3 is a transverse cross-sectional view of the
`sheath is made of elastomeric or rubber-like materials so
`delivery system as shown in FIG. 2 with the balloon
`as to fit snugly over the constricted stent with one end
`and stent in an expanded condition;
`of the sheath secured to the guidewire and one end
`FIG. 4 is a perspective view of the stent delivery
`secured to the end of the catheter or the balloon thereof
`system shown in FIGS. 1 and 2 with the guidewire and
`Means are provided, preferably at the proximal end
`attached protective sheath disposed distally to uncover
`of the catheter body, to move the guidewire through an
`the expandable stent and balloon;
`inner lumen of the catheter to enable the sheath fixed to
`FIG. 5 is a schematic elevational view, partially in
`the distal end thereof to be moved distally and to
`section, of the stent delivery system shown in FIG. 1
`thereby uncover the constricted stent on the expandable
`disposed within a stenotic arterial region;
`member. With the alternative embodiment the guide-
`FIG. 6 is a transverse cross-sectional view taken
`wire is moved distally with respect to the catheter to
`along the lines 6—6 shown in FIG. 5;
`peel the snugly fitting sheath off of the stent so that it
`FIG. 7 is a schematic elevational view as shown in
`can be expanded. Once the stent is completely exposed,
`FIG. 5, partially in section, with the guidewire and
`the expandable member disposed within the constricted
`sheath advanced distally from the stenotic region;
`stent can be expanded to expand the stent and maintain
`FIG. 8 is a schematic elevational view as shown in
`the patency of the body lumen.
`FIG. 7, partially in section, with the balloon and stent in
`Preferably, the stent is of the self-locking variety so
`an expanded state;
`that it automatically locks in the expanded condition to
`FIG. 9 is a schematic elevational view, partially in
`enable the catheter body and the expandable member
`section, of a stent in an expanded condition within an
`fixed thereto to be removed. A particularly suitable
`self-locking stent is described and claimed in copending
`artery;
`FIG. 10 is a transverse cross-sectional view taken
`U.S. patent application Ser. No. 283,729, filed on Dec.
`along the lines 10—10 shown in FIG. 9;
`13, 1988. The stent design discussed in this application
`FIG. 11 is a plan view of a flat sheet from which the
`has an open, reticulated structure which allows blood to
`stent shown in the previous figures was made;
`flow through the cylindrically shaped walls thereof and
`FIG. 12 is an expanded view of the area 12 shown in
`bathe the dissected tissue after the stent is expanded into
`FIG. 4;
`place to accelerate the healing process of the tissue.
`FIG. 13 is a partial perspective view of the stent
`The presently preferred expandable means on the
`distal end of the catheter is an inflatable balloon but
`shown in previous figures;
`FIG. 14 is a transverse cross-sectional view taken
`other expanding devices are contemplated such as me­
`along the lines 14—14 shown in FIG. 13;
`chanical expanding devices formed of metal braids
`FIG. 15 is a cross-sectional view as in FIG. 14 with
`which expand when the ends thereof are axially moved
`closer together.
`the stent in an expanded condition;
`FIG. 16 is an elevational view, partially in section, of
`The delivery system of the invention is percutane­
`an alternate embodiment of the invention;
`ously introduced into the patient’s arterial system in a
`FIG. 17 is an elevational view of the alternative em­
`conventional Seldinger technique commonly employed
`bodiment show in FIG. 16 with the guidewire extended
`in PTCA. The guidewire is steerable so that the entire
`to peel off the protective sheath; and
`stent delivery assembly can be steered through the pa­
`FIG. 18 is an elevational view as in FIG. 17 with the
`tient’s arterial system until the stent is positioned at the
`sheath further removed and the stent expanded.
`desired arterial location. Once the stent is in the desired
`location, the guidewire is moved distally with respect to
`DETAILED DESCRIPTION OF THE
`the delivery catheter a sufficient distance so that the
`INVENTION
`protective sheath which has its distal end fixed to the
`FIGS. 1-4 illustrate a stent delivery system 10 which
`guidewire is completely removed from the constricted
`embodies features of the invention. The delivery system
`stent. The balloon or other expandable member is ex­
`panded to expand the stent within the stenosis, pressing
`10 generally includes an elongated catheter body 11, an
`the stent against the arterial lining and preferably lock­
`inflatable balloon 12 on the distal portion of the catheter
`ing the stent in place. The diameter of the expandable
`body and an adapter 13 on the proximal portion of the
`member may then be reduced to disengage the catheter
`catheter body. TTie stent 14 to be delivered is mounted
`delivery system from the expanded stent and to facili­
`about the balloon 12 in a rolled up state having a rela­
`tate its removal from the body lumen.
`tively small diameter as best shown in FIGS. 1 and 2.
`The delivery system of the present invention allows
`The catheter body 11 has an outer tubular member 15
`for the rapid and safe deployment of an expandable
`and an inner tubular member 16 concentrically disposed
`stent within a patient’s vascular system or other bodily
`therein which define between them an annular inflating
`lumen and the quick removal of the delivery system
`lumen 17 for the delivery of inflation fluid to the inte­
`after the stent is expanded at the desired location within
`rior of the balloon 12. Arm 18 of the adapter 13 is in
`the lumen.
`fluid communication with annular lumen 17 and is
`These and other advantages of the invention will
`adapted to be connected to a syringe-like pumping de­
`become more apparent from the following detailed
`vice such as is described in U.S. Pat. No. 4,439,185,
`description thereof and the accompanying exemplary
`previously incorporated herein, to inflate the balloon
`drawings.
`12.
`A guidewire 20 is slidably disposed within the inner
`BRIEF DESCRIPTION OF THE DRAWINGS
`lumen 21 of inner tubular member 16. It generally com­
`FIG. 1 is an elevation view, partially in section, of a
`prises an elongated core member 22 with a flexible coil
`stent delivery system embodying features of the inven­
`23 secured to the distal end of the core member. The
`guidewire 20 is advanced out of the distal end of the
`tion;
`
`60
`
`40
`
`45
`
`50
`
`55
`
`65
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1029 - Page 9
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`

`5,158,548
`5
`6
`catheter body 11 through distal port 24, when the cathe­
`tion. See FIGS. 10 and 15. The open reticulated struc­
`ter is advanced into the coronary anatomy of the pa­
`ture allows the stent 14 to be expanded and held in an
`tient. Other types of distal guidewire constructions may
`expanded state having different diameters depending
`be employed. For example, the distal extension of the
`upon the degree of expansion of the stent. The number
`core member 22 can terminate short of the distal tip of 5 and location of the fingers 33 can be varied depending
`the coil 23 and a shaping ribbon (not shown) can extend
`upon the needs of the intended use of the stent 14.
`between the core member and the distal tip of the coil.
`The materials of construction and the methods of
`A torquing member 25 is secured to the proximal end of
`manufacturing of the stent and delivery system can be
`the core member 23 which extends out of the central
`of a conventional nature which are well known to those
`arm 26 of adapter 13. The torque applied to the proxi- 10 skilled in the art. The catheter body may be made of
`mal end of the core member 23 is transmitted to the
`suitable polymers such as polyethylene, polyester, poly-
`flexible distal coil 23 of the guidewire 20 so that when
`imide and the like. The balloon 12 and the protective
`shaped the guidewire can be steered to a desired loca­
`sheath 27 can be bonded to their supporting members
`tion within the patient’s vascular system.
`by suitable means, such as acrylonitrile based adhesives.
`A tubular protective sheath 27 is secured by its distal 15 In the embodiment shown, the sheath 27 should be
`formed from material of sufficient strength and/or wall
`end by suitable means such as an adhesive to the guide-
`wire 20. The sheath 27 has a diameter which is of suffi-
`thickness so that it will retain its cylindrical shape when
`cient size so that the sheath can easily fit over and be
`the mounting and the removing of the sheath from the
`removed from the rolled up stent 14 mounted on the
`stent 14.
`The core member 22 of the guidewire 20 may be
`balloon 12. As shown in FIG. 4, the protective sheath 20
`stainless steel, and the coil 23 may be at least partially
`27 is removed from the balloon 12, thereby exposing the
`expandable stent 14, by distally advancing the guide-
`made of a highly radiopaque metal such as platinum.
`wire 20 to which the distal end of the sheath is attached.
`tungsten, rhenium, ruthenium or alloys of such metals
`The guidewire 20 need not be removable from the dila­
`to facilitate the fluoroscopic observation of the coil
`tation catheter 10 ,but it must be longitudinally movable 25 when the guidewire is disposed within the patient.
`a sufficient distance to completely remove the sheath 27
`For long term use, the stent 14 should be made of
`from the stent 14.
`suitable biocompatible material such as steel or tung­
`sten. The flat sheet which forms the stent 14 may be of
`The sequence of steps shown in FIGS. 5-9 illustrate
`any suitable length and width depending upon the size
`the use of the stent delivery system of the invention to
`deliver a rolled-up expandable stent 14 to a stenotic 30 of the body lumen into which it will be disposed. For
`coronary artery use typically the length will be about
`region within a patient’s artery. In FIGS. 5 and 6, the
`delivery system 10 is shown disposed within an artery
`1.5 to about 4 cm, the width about 0.5 to about 1.5 cm
`with the stent 14 in a rolled-up, constricted state about
`and the thickness about 0.02 to about 0.125 mm.
`FIGS. 16-18 illustrate an alternate embodiment of the
`the balloon 12 with the protective sheath 27 positioned
`over the rolled-up stent 14. In FIG. 7, the guidewire 20 35 invention wherein the sheath 27 is secured by its distal
`has been moved distally with respect to the catheter
`end to the core member 22 and by its proximal end to
`body in order to remove the sheath 27 covering the
`the distal end of the catheter body 11. The sheath 27 is
`rolled-up stent 14. In FIG. 8, the balloon 12 has been
`doubled over the stent 14 and preferably snugly fits
`thereover. The sheath 27 is formed of more flexible
`inflated to expand the stent 14 and to hold the stenotic
`region in a dilated condition as shown. The stent 14 is 40 material than is the previously discussed embodiment
`preferably of a self-locking type so that, once it is ex­
`and may be made from a wide variety of elastomeric
`panded and the balloon 12 deflated, it contracts slightly
`material, such as polyurethane and rubber.
`either from the pressure of the artery or by internal
`The sequence shown in FIGS. 16-18 illustrates the
`stresses within the stent itself to lock itself in the ex­
`operation of the device which is essentially the same as
`panded condition. The deflated balloon can then be 45 shown in FIGS. 5-9. In FIG. 16 the device as intro­
`removed from within the expanded stent 14 which is
`duced into the patient’s artery and advanced therein
`pressing against the arterial lining as shown in FIGS. 9
`through the stenosis. In FIG. 17 the flexible sheath 27 is
`removed from the stent 14. The guidewire 20 is moved
`and 10.
`Structural details of the stent 14 can be found in distally as with the embodiment shown in FIG. 1, and
`FIGS. 11-15, particularly FIG. 12. FIG. 11 illustrates 50 this movement peels the flexible elastomeric sheath 27
`the open, reticulated structure in a flat sheet form prior from the stent 14. As shown in FIG. 18 the stent 14 is
`to being shaped by rolling the longitudinal edge section expanded by the expansion of the balloon 12 as with the
`30 over the longitudinal edge section 31 into the cylin- previously described embodiment. Once the stent 14 is
`drically shaped stent shown in FIGS. 13 and 14. The expanded and locked into place, the catheter delivery
`preferred open reticulated structure includes an array of 55 system 10 and guidewire 20 can be removed from the
`diamond shaped apertures 32. As shown in FIG. 13,
`patient’s artery.
`fingers 33 are provided which project into the diamond­
`While the invention has been described herein in
`shaped apertures 32. When the stent 14 is rolled up as terms of certain preferred embodiments, those skilled in
`shown in FIGS. 13 and 14, the fingers 33 project tan- the art will recognize that various modifications can be
`gentially from the rolled-up cylindrically shaped sur- 60 made. For example, the guidewire receiving lumen can
`face and point in the same direction as of the movement be relatively short ahd extend about 10 to 40 cm from
`of the overlaying section when the stent unrolls during the distal end of the catheter and be provided with a slit
`the expansion thereof. The pressure of the artery wall proximal to the expandable member as described in U.S.
`or the elasticity of the rolled up sheet will cause the Pat. No. 4,748,982 to facilitate the rapid exchange
`expanded stent to contract somewhat thereby causing 65 thereof. Other modifications and improvements can be
`the fingers 33 to project through the diamond-shaped made without departing from the scope of the inven-
`apertures 32 therein and to engage the perimeter of such tion.
`What is claimed is:
`apertures and to lock the stent in the expanded condi-
`i
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1029 - Page 10
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`

`

`5,158,548
`7
`8
`8. The stent delivery system of claim 7 wherein the
`1. A stent delivery system, comprising;
`open reticulated structure comprises an array of
`a) an elongated catheter body having an expandable
`diamond shaped apertures.
`member on the distal end thereof and at least one
`9. The stent delivery system of claim 8 wherein the
`inner lumen extending therein;
`5 diamond shaped apertures have long and short dimen­
`b) an expandable stent which is disposed about the
`sions and the fingers point in the longitudinal direction.
`expandable member in a contracted condition;
`10. The stent delivery system of claim 1 wherein the
`c) a guidewire which is disposed within the inner
`sheath has an inner diameter of sufficient size to be slid
`lumen of the catheter body and which has a distal
`disposed about the expandable
`portion extending out the distal end of the catheter jq member,
`11. The stent delivery system of claim 1 wherein the
`body;
`d) a protective tubular sheath which is secured by its
`sheath is formed of flexible material, has a proximal end
`distal end to the distal portion of the guidewire
`secured to the distal end of the catheter body and is
`extending out of the distal end of the catheter body
`doubled over the stent.
`12. The stent delivery system of claim 11 wherein the
`and which fits over the stent disposed about the 15
`sheath snugly fits over the stent.
`expandable member;
`13. A method of delivering an expandable stent to a
`e) means to move the guidewire distally through the
`region within a patient’s bodily lumen, comprising:
`inner lumen to remove the sheath from the stent;
`a) providing a stent delivery system which includes
`f) means to expand the expandable member to thereby
`an elongate catheter body with an expandable
`expand the stent surrounding the expandable mem­
`member on the distal end thereof and a guidewire
`ber;
`disposed within an inner lumen in the catheter
`g) means to hold the stent in an expanded condition;
`body with a distal p>ortion of the guidewire extend­
`and
`ing out of the distal end of the catheter body with
`h) means to contract the expanded member so that it
`a tubular protective sheath secured by the distal
`can be removed from the stent in the expanded
`end thereof to the distal portion of the guidewire;
`b) mounting an expandable stent in a contracted con­
`condition.
`2. The stent delivery system of claim 1 wherein the
`dition onto the expanded member
`expandable member is an inflatable balloon.
`c) disposing the protective tubular sheath over the
`expandable stent mounted on the expandable mem-
`3. The stent delivery system of claim 2 wherein the 30
`elongated catheter body has a second lumen extending
`ber
`d) advancing the stent delivery system through a
`therein which is in fluid communication with the inte­
`patient’s bodily lumen until the stent is disposed
`rior of the inflatable balloon to direct inflation fluid
`within a desired region therein;
`therein.
`e) advancing the guidewire distally within the lumen
`4. The stent delivery system of claim 1 wherein the
`to remove the protective sheath from over the
`distal end of the tubular protective sheath is tapered.
`mounted stent;
`5. The stent delivery system of claim 1 wherein the
`f) expanding the expandable member to expand the
`stent is formed of flat sheet which is rolled up into the
`stent thereon;
`contracted condition and mounted onto the expandable
`g) locking the stent in an expanded condition; and
`member.
`h) contracting the expandable member sufficiently to
`6. The stent delivery system of claim 5 wherein the
`facilitate removing the expandable member from
`stent has overlapping longitudinal edge sections, the
`within the expanded stent.
`inner most edge section having fingers which project
`14. The method of claim 13 wherein the stent deliv­
`outwardly and engage apertures in the outer overlaying 45
`ery system is removed from the patient’s body lumen.
`longitudinal sections to lock the stent in an expanded
`15. The method of claim 13 wherein the expandable
`condition when the stent is expanded.
`member is an inflatable balloon and wherein the balloon
`7. The stent delivery system of claim 1 wherein the
`is inflated with inflation liquid.
`*
`stent has an open reticulated structure.
`
`20
`
`25
`
`40
`
`50
`
`55
`
`60
`
`65
`
`\
`
`I
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1029 - Page 11
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`