BSC USP 8,142,413
`Exhibit 1014
`
`Page 1 of 32
`
`Umted States Patent [19]
`Klein et a1.
`
`' llllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllll
`[11] Patent Number:
`5,776,141
`[45] Date of Patent:
`Jul. 7, 1998
`
`[54] METHOD AND APPARATUS FOR
`[NTRALUMINAL PROSTHESIS DELIVERY
`
`
`[75] Inventors: Enrique J. Klein; Aaron V. Kaplan; ' .
`
`Mark. Chlford' all of L05 Aims’
`Martin Overbeek-Bloem. Palo Alto. all
`of Calm
`
`_
`_
`[73] ASSlgllCCZ LocalMed, Inc., P810 A110. Callf.
`
`[21] App1_No,;704,s01
`
`[22] P116112
`
`Aug. 26, 1996
`
`Related US. Application Data
`
`[60] Provisional application No. 60/Om,847 Aug. 28, 1995.
`[51] Int. Clf" .................................................... .. A61F 11/00
`[52] us. c1. ......................... .. 606/108; 606/195: 606/198
`
`9/1993 Lau et a1. ..
`5,242,399
`9/1994 Lau et all
`5,344,426
`5,360,401 11/1994 Turnland et all
`1:;
`
`,
`113:0“ 8‘ 31' H132 ............... ..
`4/1995 Osborn ............... ..
`5,409,495
`5 443 500 3/1995 sigwm
`5,445,646 8/1995 Euteneuer et 61
`5,507,768
`4/1996 Lau et a1. ........... .,
`5534907 7/1996 St‘ Germain a al_
`5545209 8/1996 Robertsetal.
`5,549,563
`8/1996 Kronner ......... ..
`5.571,036 11/1996 Kaplan et al.
`5,591.222
`1/1997 Susawa et a1.
`5,620,457
`4/1997 Pinchasik et a1.
`
`604/104
`. 606/198
`.. 604/96
`
`606/108
`623“
`606/198
`606/198
`606/103
`623/1
`. 606/164
`604/108
`.. 623/1
`606/194
`
`FOREIGN PATENT DOCUMENTS
`O 533 960 3/1993 European Pat O?,
`WO 95/1105 4/1995 WIPO‘
`WO 96/33677 10/1996 WIPO‘
`
`[58]
`
`[56]
`
`F' l
`
`f
`
`‘e d 0 Search
`
`................................... ..
`
`606/192 $3113; 11%;
`‘
`‘
`'
`
`.
`
`.
`
`References Cited
`
`US. PATENT DOCUMENTS
`4,292,974 10/1981 Fogarty et a1. ....................... .. 128/344
`4,323,071
`4/1982 Simpson et a],
`_, 123/343
`4,665,918
`5/1987 Garza et a],
`.... .. 623/1
`4,733,665
`3/1933 P3111131
`123/343
`41762429 8/1988 B09161
`'- 123/344
`"
`
`Jr‘ '
`6/1989 Schonst/edt et al.
`4:839:623
`4 877 030 10/1989 Beck et aL ________ "
`4:950:227
`8/1990 savmel A1 ____ __
`5914939 5/1991 gakashjm et al_
`5,019,090
`5/1991 Pinchuk .... ..
`5.026377 6/1991 Burton et al.
`Elm/117 4/1992 Palmal ------ '-
`5,103,416
`4/1992 Ryan et a1-
`
`is’:
`£163,352 “"992 a“. ct
`5,195,984
`3/1993
`5,219,355
`6/1993
`
`' ' ' ' ' ' '
`
`336/213
`128/343
`606/192
`355/251
`606/194
`606/108
`-' 606/195
`'- 696/191
`
`' ‘ ‘ ' “633735
`"
`9
`
`.
`
`.
`
`Prlmary Exammer-Robert A. Hafer
`Assistant Examiner-Justine R. Yu
`Attorney, Agent, or Firm-Townsend and Townsend and
`Crew LLP
`[57]
`
`ABSTRACT
`
`A catheter for use in combination with a balloon angioplasty
`catheter for delivering stents and other intraluruinal pros
`theses comprises a tubular catheter body having a radially
`expansible portion. The stent is disposed over the radially
`expansible portion. and structure is provided for retaining
`the .stf‘m 0” the tubular b°d.y pr.“ ‘0 diPloymm' The
`retaining structure may be active. 1.e., requiring the user to
`retract retaining elements. such as
`members. sheaths.
`or the like. Alternatively. the retaining structure may be
`passive. wherein balloon expansion results in release of the
`prosthesis from the retaining structure. Particular methods
`for ?uoroscopically positioning stents using such delivery
`catheters. for delivering two or more stents using such
`
`delivery catheters. and for overexpanding the ends of the
`stents for anchoring them in place. are also described.
`
`23 Claims, 22 Drawing Sheets
`
`

`

`US. Patent
`
`Jul. 7, 1998
`
`Sheet 1 of 22
`
`5,776,141
`
`
`
`PageZof32
`
`Page 2 of 32
`
`US. Patent
`
`Jul. 7, 1998
`
`Sheet 1 0f 22
`
`5,776,141
`
`

`

`US. Patent
`
`Jul. 7, 1998
`
`Sheet 2 of 22
`
`5,776,141
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`Page 3 of 32
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`US. Patent
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`Jul. 7, 1998
`
`Sheet 2 of 22
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`5,776,141
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`Page 4 of 32
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`US. Patent
`
`Jul. 7, 1993
`
`Sheet 3 0f 22
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`US. Patent
`
`Jul. 7, 1998
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`US. Patent
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`Jul. 7, 1998
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`Sheet 5 of 22
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`Page 7 of 32
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`US. Patent
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`Jul. 7, 1998
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`Page 13 of 32
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`US. Patent
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`Jul. 7, 1998
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`Sheet 12 of 22
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`US. Patent
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`Jul. 7, 1998
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`Page 15 of 32
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`US. Patent
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`Jul. 7, 1998
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`Sheet 14 of 22
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`Page 16 of 32
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`Jul. 7, 1998
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`Jul. 7, 1998
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`US. Patent
`
`Jul. 7, 1998
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`Sheet 18 0f 22
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`Page 20 of 32
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`US. Patent
`
`Jul. 7, 1993
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`Sheet 19 of 22
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`US. Patent
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`Jul. 7, 1998
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`Sheet 20 of 22
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`Page 21 of32
`
`Page 21 of 32
`
`

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`US. Patent
`
`Jul. 7, 1998
`
`Sheet 21 of 22
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`US. Patent
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`Jul. 7, 1998
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`Sheet 22 of 22
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`Page 23 of 32
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`Page 23 of 32
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`

`

`5.776.141
`
`2
`
`heretofore relied on use of a separate delivery catheter.
`usually in the form of a dedicated catheter which has been
`designed for containing and deploying the stent. The need to
`employ a separate balloon catheter is costly. While in some
`cases the angioplasty balloon catheter used to initially treat
`the patient is reused by manually crimping the stent thereon
`prior to use. the handling and positioning the stent over the
`deflated angioplasty balloon is difficult. Intravascular stents
`are very small and require significant dexterity and time in
`order to properly be positioned over a balloon catheter.
`Other concerns raised by the intravascular delivery of stents
`include (1) exposure of the stent on the exterior of the
`balloon delivery catheter which can cause trauma to the
`blood vessel and/or jamming within a guiding catheter
`during tracking. (2) loss of the stent during tracking. (3)
`misalignment of the stent relative to the balloon during
`delivery. and (4) difficulty in firmly anchoring the ends of the
`stent within the blood vessel following the initial balloon
`deployment of the stent.
`For these reasons. it would be desirable to provide meth-
`ods and apparatus for delivering intraluminal stents which
`overcome some or all of the difficulties described above. In
`
`particular. it would be desirable to provide stent delivery
`systems which do not require use of a separate balloon
`catheter for positioning and deployment of the stent. More
`specifically. it would be desirable to provide methods and
`devices which are able to reuse the balloon catheter which
`had been used for the primary angioplasty treatment for
`positioning and deployment of a stent. and in some cases
`two or more stents. The methods and systems of the present
`invention should provide for containment of the stent in the
`guide catheter during delivery to inhibit trauma to the
`vasculature and jamming of the stent and to prevent loss or
`misalignment of the stent from the delivery apparatus. The
`method and apparatus of the present invention should further
`inhibit deformation of the stent prior to radial expansion at
`the target site. and should further permit easy fluoroscopic
`tracking and positioning of the stent during the delivery
`procedure. It would be even more desirable if the methods
`and apparatus of the present invention could provide for
`improved anchoring of the ends of the stent in the blood
`vessel wall.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`45
`
`50
`
`55
`
`2. Description of the Background Art
`The use of a tubular catheta in combination with a
`
`balloon catheter for delivering a stent to a target site in a
`body lumen is disclosed in copending parent application
`US. patent application Ser. No. DIR/222.143. filed on Apr. 1.
`1994. naming Kaplan. Kermode. and Klein as inventors. and
`assigned to the assignee of the present application. The full
`disclosure of this application has been incorporated herein
`by reference.
`Balloon catheters specially designed for carrying and
`delivering stents are described in US. Pat. Nos. 5.507.768;
`5.409.495; 5.360.401; 5.242.399; and 5.158.548; PCI‘ pub-
`lished application W0 95/1 1055; and EP 553 960. The ’768
`patent describes a tubular cover that extends over the
`stent/balloon combination.
`
`1
`METHOD AND APPARATUS FOR
`INTRALUMINAL PROSTHESIS DELIVERY
`
`CROSS—REFERENCE TO RELATED
`APPLICATION
`
`This application is a continuation-in-part of provisional
`application Ser. No. 60/002.847. filed on Aug. 28. 1995. the
`complete disclosure which is incorporated herein by refer-
`ence.
`
`BACKGROUND OF THE INVENTION
`
`1. Field of the Invention
`
`The present invention relates generally to methods and
`devices for delivering tubular prostheses to intraluminal
`target sites. In particular. the method and device relate to the
`delivery of intravascular stents using a sleeve catheter to
`position the stent over a balloon catheter for expansion at the
`target site.
`
`In percutaneous transluminal coronary angioplasty
`(PFCA) procedures. a catheter having an expansible distal
`end. usually in the form of a balloon. is positioned in a lumen
`of a blood vessel with the distal end disposed within a
`stenotic atherosclerotic region of the vessel. The expansible
`end is then expanded to dilate the vessel and. upon
`withdrawal. restores adequate blood flow through the dis—
`eased region.
`While angioplasty has gained wide acceptance. it contin-
`ues to be limited by two major problems. abrupt closure and
`restenosis. Abrupt closure refers to the acute occlusion of a
`vessel immediately after or within the initial hours following
`the dilatation procedure. This complication occurs in
`approximately one of twenty cases and frequently results in
`myocardial infarction and death if blood flow is not quickly
`restored. Restenosis refers to the re-narrowing of an artery
`after an initially successful angioplasty. Occurring usually
`within the initial six months after angioplasty. and restenosis
`afflicts approximately one in three cases. That is. approxi—
`mately one in three patients will require additional revas-
`cularization procedures.
`Many difierent strategies have been tried with different
`degrees of success to reduce restenosis and abrupt closure.
`including pharmacologic (e.g.. systemic and localized
`administration of anti—proliferative agents and other drugs)
`and mechanical
`(e.g.. prolonged balloon inflations.
`atherectomy.
`laser angioplasty. post-angioplasty thermal
`conditioning. and stenting). Of particular interest to the
`present invention. the intravascular delivery and implanta-
`tion of stents to a blood vessel following balloon angioplasty
`procedures has proven to be of great value. The first stent to
`achieve widespread acceptance is the Palmaz-Schatz stent
`available from Johnson & Johnson Interventional Systems.
`a division of Ethicon. Inc.. Somerville. NJ. The Palmaz-
`Schatz stent is a slotted tube formed from a malleable
`material. For delivery to the target site. the stent is provided
`or placed over the balloon of a balloon delivery catheter
`having a non-distensible balloon. The delivery catheter is
`then exchanged for the angioplasty balloon catheter. and the
`stent positioned at the angioplasty treatment site. The bal-
`loon of the delivery catheter is then inflated to expand the
`stent in situ in order to implant the stent within the blood
`vessel.
`
`While stents have proven to be quite successful in reduc—
`ing rates of restenosis and abrupt closure. prior methods and
`devices for delivering stents sulfer from certain problems. In
`particular. the delivery of radially deformable stents has
`
`65
`
`Sleeve catheters having a distal tubular portion adapted to
`receive a balloon catheter and a proximal shaft portion
`which will lie parallel to but not coaxially with the body of
`the balloon catheter are disclosed in copending application
`Ser. Nos. 08/461.222. filed on Jun. 5. 1995. naming Klein.
`Bajor. Alba. and Kaplan as inventors. and Ser. No. 08/221.
`613. filed on Apr. 1. 1994. naming Klein. Bajor. Alba and
`Kaplan as inventors. both of which are assigned to the
`assignee of the present application. the full disclosure of
`which is incorporated herein by reference.
`
`PageZ40f32
`
`Page 24 of 32
`
`

`

`5.776.141
`
`4
`
`3
`SUMMARY OF THE INVENTION
`
`According to the present invention. devices and methods
`are provided for the delivery of tubular prostheses to target
`locations within body lumens. While particularly intended
`for the post-angioplasty delivery of intravascular stents. the
`method would also find use with the delivery of other stents.
`grafts. and the like. to other body lumens. such as the
`delivery of urethral stents for the treatment of prostate
`conditions. and the like. The present invention relies on the
`use of a delivery catheter in combination with a separate
`balloon catheter. usually a conventional balloon dilatation
`catheter. such as a PFCA catheter. The delivery catheter of
`the present invention comprises a tubular catheter body
`having a proximal end. a distal end. a lumen therebetween.
`and a radially expansible portion. usually disposed near the
`distal end. The lumen of the catheter body is adapted to
`receive the balloon catheter so that the balloon of the balloon
`catheter can be aligned within the radially expansible por—
`tion of the catheter body. The stent. graft. or other tubular
`prosthesis will be positionable over the radially expansible
`portion of the catheter body. In this way. expansion of the
`balloon within the lumen of the tubular catheter body will
`radially enlarge the prosthesis to deploy the prosthesis
`within the body lumen.
`The present invention provides prosthesis retaining struc-
`ture on the tubular catheter body near the radially expansible
`portion thereof to releasably attach the prosthesis over the
`radially expansible portion of the body. The particular
`structure which is incorporated in the device can provide one
`or more of the design objectives described above. In
`particular. the structure will usually retain the prosthesis in
`place on the delivery catheter during the intraluminal intro-
`duction and positioning of the catheter. Thus.
`loss and
`misalignment of the prosthesis is prevented. The structure
`can further cover all or a portion of the prosthesis in order
`to reduce the risk of trauma to the body lumen and jamming
`of the catheter during delivery. The structure can still further
`inhibit unintended deformation of the prosthesis (e.g..
`“trumpeting” of the ends of an intravascular stent) during
`delivery. In addition. the structure on the catheter can be
`adapted to enhance fluoroscopic imaging of both the catheter
`and prosthesis during the delivery protocol.
`The delivery catheter of the present invention preferably
`further comprises a proximal shaft attached to the proximal
`end of the tubular catheter body. The tubular catheter body
`will typically have a length in the range from 5 cm to 40 cm.
`with the radially expansible portion thereof having a length
`in the range from 2.5 cm to 4.5 cm. The length of the tubular
`body may be somewhat greater when the catheter is
`designed to deliver two or more stents. as described in
`connection with FIGS. 23—25 below. The remaining length
`of the delivery catheter is then provided by the proximal
`shaft. which has a length in the range of 90 cm to 150 cm
`The proximal shaft is. typically in the form of a small—
`diameter metal rod or hypotnbe. In such an embodiment. the
`proximal shaft will be disposed parallel to the body of the
`balloon catheter within the body lumen and/or guiding
`catheter through which it is being delivered. In an alternative
`embodiment. the tubular catheter body of the delivery cath-
`eter will have a substantially greater length. typically from
`100 cm to 175 cm. so that the delivery catheter may be
`disposed coaxially over substantially the entire length of the
`balloon catheter with which it is being used.
`In a second particular aspect of the catheter of the present
`invention. the prosthesis-retaining structure is configured to
`axially span the entire length of the prosthesis which it is
`
`holding on the catheter body. For example. the structure may
`comprise a sheath which is slidable between a first position
`covering the radially expansible portion of the catheter body
`and a second position proximal to the radially expansible
`portion. Alternatively. the structure may comprise an even-
`ible sheath which may be drawn down from a first position
`covering the radially expansible portion of the tubular
`catheter body and a second position which clears the expan-
`sible portion. As another alternative.
`the structure may
`comprise one or more axial members which are slidable
`between a position covering the expansible portion and a
`second position clear of the expansible portion. It will be
`appreciated that for each of these alternatives. the prosthesis
`present over the radially expansible portion of the catheter
`body will be contained over its entire length to prevent loss
`and misalignment. Moreover. in the case of the covering
`sheaths. the entire exterior of the prosthesis will be covered
`to protect against trauma and jamming during delivery. The
`sheaths and axial members will cover the prosthesis during
`the initial delivery and placement. and may then be retracted
`to permit radial expansion and placement of the prosthesis
`using the separate balloon catheter. as described in more
`detail below.
`
`The prosthesis-retaining structure may alternatively be
`configured to engage only the proximal and distal ends of the
`tubular prosthesis. In particular. proximal and distal collars
`may be provided on the tubular body to engage and cover the
`proximal and distal ends of the prosthesis when the radially
`expansible portion of the tubular body is in its non-expanded
`state. When the expansible portion is radially expanded by
`use of the separate balloon catheter. however. the prosthesis
`will be radially expanded and pulled from the cover of the
`collars. This is particularly true of those stent designs. such
`as the Palmaz-Schatz stent. which axially foreshorten as
`they are radially expanded.
`In a particular embodiment. the collars may be elasto—
`men‘c and arranged to constrain expansion of the proximal
`and distal ends of the balloon so that the balloon expands
`first over its central portion. Such initial central expansion of
`the balloon acts to pull the ends of the prosthesis from the
`collars. In another embodiment. the collars may comprise
`serpentine rings which axially foreshorten to release the
`prosthesis as the tubular catheter body radially expands. In
`still other embodiments. the collars may be non-elastomeric
`(non—distensible). and will usually be split along axial lines
`in order to permit expansion with the tubular body.
`The prosthesis retaining structure of the present invention
`may also comprise abutting surfaces on the tubular catheter
`body which engage or mate with transverse surfaces on the
`prosthesis. such as transverse walls or segments within or at
`the ends of the prosthesis. The abutting surfaces may be
`defined by spaced-apart rings disposed on the catheter body.
`and/or by the ends of a cavity formed in the catheter body.
`Alternatively.
`the abutting surfaces may be defined by
`protrusions (“bumps") on the catheter body which engage
`gaps present in the tubular prosthesis prior to radial expan-
`sion.
`
`As yet another alternative. the retaining structure of the
`present invention may comprise one or more straps which
`secure the prosthesis to the catheter body. Straps will typi-
`cally be frangible or otherwise constructed or attached so
`that the straps will release the prosthesis in response to radial
`expansion of the catheter body.
`The radially expansible portion of the tubular catheter
`body may be formed in a variety of ways. For example. it
`may be defined by forming a plurality of axial slits in the
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`tubular wall of the catheter body. The slits move circumfer-
`entially apart as the tubular body is radially expanded by
`inflation of a balloon therein. Alternatively. the expansible
`portion may be formed by fabricating the tubular body at
`least in part from an elastomeric material which permits
`expansion. In another preferred embodiment. an axially split
`tubular catheter body is modified by the inclusion of non-
`distensible or elastomeric webs between adjacent axial seg-
`ments. The axial segments resulting from splitting of the
`tubular body provide significant column strength. while the
`web portions fully contain the balloon within the lumen of
`the catheter body even after full expansion. The use of
`non-distensible webs can further be relied on to limit maxi—
`mum balloon expansion. if so desired.
`The delivery catheter of the present invention is prefer—
`ably combined with a radially expansible tubular prosthesis
`which is disposed over the radially expansible portion of the
`tubular catheter body. Such “pm-loading” of the stent or
`other prosthesis eliminates the need for the placement of the
`stent over the delivery system at
`the time of use. The
`delivery catheters of the present invention. moreover. are
`significantly less expensive than the use of a separate
`balloon delivery catheter. Preferably. the pre-loaded delivery
`catheters of the present invention will be present in a sterile
`package so that they are immediately available for use with
`minimal additional preparation.
`According to the methods of the present invention. a
`tubular catheter body having the prosthesis disposed over a
`radially expansible portion thereof is positioned over a
`balloon catheter at a target site within a body lumen. The
`balloon catheter is expanded within the lumen of the tubular
`catheter to expand the prosthesis in situ at the target site.
`Prior to or during expansion. the prosthesis will be released
`from the tubular catheter body. The releasing step typically
`comprises selectively releasing a constraint on the prosthesis
`prior to inflating the balloon. For example. the constraint
`releasing step may comprise drawing a sheath from over the
`prosthesis. drawing one or more axial members from over
`the sheath. or other such active steps. Alternatively.
`the
`releasing step may be responsive to the balloon inflation
`step. For example. the releasing step may comprise short-
`ening of the prosthesis as a result of radial expansion of the
`tubular catheter body. In such a case. the prosthesis may be
`released from a pair of spaced apart collars. as described
`above. Alternatively.
`the collars themselves may axially
`foreshorten upon radial expansion of the tubular catheter
`body. as in the case of elastic serpentine rings described in
`more detail below. As a further alternative. the releasing step
`may comprise breaking a strap or other engaging members
`as a result of radial expansion of the tubular body. also as
`described above.
`
`In another aspect of the present invention. a radially
`expansible tubular prosthesis is delivered to a target site
`under fluoroscopic imaging. A tubular catheter body carries
`the tubular prosthesis over a radially expansible portion
`thereof. A fluoroscopic marker on the tubular catheter body
`is aligned with a fluoroscopic marker on a balloon catheter
`so that the tubular prosthesis is properly aligned over the
`radially expansible portion of the catheter body. A pair or
`axially spaced apart fluoroscopic markers. either on the
`prosthesis or on the catheter body. are then verify position-
`ing of the prosthesis within the target site and/or to position
`the prosthesis prior to delivery by moving the balloon
`catheter and tubular catheter body in unison.
`In another specific aspect of the method of the present
`invention. two or more radially expansible tubular prosthe-
`ses may be delivered to the same or diiferent target sites in
`
`a body lumen. At least two tubular prostheses are carried on
`a tubular catheter body which has axially spaced-apart
`radially expansible portions. A first of the radially expan—
`sible portions having a prosthesis thereover (usually the
`distalmost) is then positioned at a first location within the
`body lumen. The prosthesis may be delivered by expanding
`a balloon therein. generally as described above. A second
`radially expansible portion of the tubular body. also carrying
`a prosthesis. is then positioned at a second target site within
`the body lumen. The same balloon is then inflated within the
`tubular catheter body to deploy the prosthesis at the second
`target site.
`
`In yet another aspect of the method of the present
`invention. a deployed tubular prosthesis in a body lumen
`may be anchored by positioning a tubular catheter over a
`balloon within the deployed prosthesis. The balloon is then
`inflated Within the tubular catheter to expand the catheter
`and engage at least one protrusion on the catheter body
`against the end of the prosthesis to selectively expand and
`anchor said end within the lumen. Preferably. the tubular
`body will include a pair of spaced-apart protrusions. so that
`a single expansion of the balloon will engage both protru-
`sions against the two ends of the prosthesis.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a perspective View of a prosthesis delivery
`catheter constructed in accordance with the principles of the
`present invention. with specific prosthesis retaining struc-
`tures shown in FIGS. 2—16.
`
`FIGS. 2—5 illustrate a first exemplary retaining structure
`employing a plurality of retractable axial members which
`cover the prosthesis prior to balloon deployment.
`FIG. 6 illustrates a second exemplary embodiment of the
`retaining structure which employs a retractable sheath which
`covers the prosthesis prior to balloon deployment.
`FIGS. 7. 7A. 7B. and 7C illustrate a preferred embodi-
`ment of the retaining structure of FIG. 6.
`FIG. 8 illustrates an additional variation of the embodi-
`ment of FIG. 6.
`FIG. 9 illustrates a further variation on the embodiment of
`FIG. 6.
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`FIGS. 9A—9H illustrate a specific embodiment of a pros-
`thesis delivery catheter having the features of the catheter of
`FIG. 9.
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`FIGS. 10—11 illustrate a third exemplary embodiment of
`the retaining structure of the present invention. employing
`an evertible sheath for covering a prosthesis prior to balloon
`deployment.
`FIGS. 12-14 illustrate a fourth exemplary embodiment of
`the retaining structure of the present invention. wherein a
`pair of axially spaced-apart collars constrain opposite ends
`of the tubular prosthesis on the deliver catheter of the present
`invention prior to balloon deployment.
`FIG. 15 illustrates a fifth exemplary embodiment of a
`prosthesis delivery catheter according to the present
`invention. wherein a prosthesis is retained within a cavity on
`the tubular catheter body and wherein a pair of spaced-apart
`collars overlap opposite ends of the cavity.
`FIGS. ISA—15C illustrate still further prosthesis retaining
`structures which may be employed in the delivery catheters
`of the present invention.
`FIG. 16 illustrates a sixth exemplary embodiment of the
`retaining structure of the present invention. wherein a plu-
`rality of individual straps anchor a prosthesis to the catheter
`body.
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`5.776.141
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`7
`FIGS. 17A and 17B illustrate the release of a structural
`element of the prosthesis of FIG. 16 from the strap.
`FIGS. 18A and 18B illustrate radial expansion of an
`axially split catheter body configuration.
`FIGS. 19A and 19B illustrate radial expansion of an
`axially split catheter body having web elements between
`adjacent axial segments.
`FIGS. 20—22 illustrate positioning of a prosthesis delivery
`catheter over a balloon catheter using specially positioned
`fluoroscopic markers.
`FIGS. 23—25 illustrate use of a prosthesis delivery cath-
`eter which carries a pair of prosthesis thereon.
`FIGS. 26—27 illustrate use of a special tubular catheter for
`anchoring the ends of a previously deployed stent in a
`tubular body lumen.
`FIGS. 28—33 illustrate use of the catheter of FIGS. 9A—9H
`for delivering a stent according to the method of the present
`invention.
`
`FIGS. 34—36 illustrate alternative embodiments for the
`radially expansible portion of the delivery catheters of the
`present invention.
`
`DESCRIPTION OF THE SPECIFIC
`EMBODIMENTS
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`The present invention provides methods and devices for
`performing multiple. sequential intralurninal procedures on
`a patient as part of a
`therapeutic treatment. By
`“intraluminal.” it is meant that the procedures occur at a
`target site within a body lumen, usually being within the
`patient vasculature. more usually being within the arterial
`system.
`including the coronary arteries.
`the peripheral
`arteries. and the cerebral arteries. The methods and devices
`of the present invention. however. are not limited to use in
`the vascular system. and may also be advantageously
`employed in other body structures. including the prostate via
`the prostatic urethra. (e.g.. to treat benign prostatic hyper—
`trophy (BPI-l). or adenocarcinoma). the fallopian tube via its
`lumen (to treat strictures). brain parenchyma (to treat Par-
`kinson’s disease). and the like.
`The “target site" within the body lumen will usually be
`diseased or be suspected of being diseased. In the case of
`vascular treatment.
`the target
`locations will usually be
`stenotic regions which have previously been treated con-
`ventional balloon angioplasty procedures using a balloon
`angioplasty catheter which may be reused in the method of
`the present invention. as described below.
`The apparatus and methods of the present invention are
`particularly intended for the delivery of tubular prostheses to
`the target site in the body lumen. Tubular prostheses include
`both stents and graft structures. particularly intravascular
`stents and grafts of the type used to maintain vessel patency
`following balloon angioplasty treatment procedures. The
`stent and graft structures are preferably of the malleable or
`deformable type wherein the stent is initially in a narrow
`diameter configuration to facilitate intralurninal deli