USOO5702418A
`[11] Patent Number:
`[45] Date of Patent:
`
`5,702,418
`Dec. 30, 1997
`
`6/1991 Burton et a1. .
`5,026,377
`5,159,920 11/1992 Condonetal.
`5,411,507
`5/1995 Heckele ..............
`5,480,423
`1/1996 Ravenscroft et a1.
`5,484,444
`1/1996 Braunschweiler et a1.
`FOREIGN PATENT DOCUWNTS
`8704935 8/1987 WIPO
`Primary Examiner-Michael Buiz
`Assistant Examiner-William Lewis
`Attorney Agent, or Firm-Pearson & Pearson
`
`606/108
`... 606/108
`623/1
`606/191
`
`606/198
`
`ABSIRACT
`[57]
`A stent delivery system includes a catheter with an axially
`extending inner core and outer sheath. Axially spaeed rings
`extending from a relatively narrow diameter portion of the
`inner core proximate the distal end thereof. The rings engage
`proximal portions of a compacted stent disposed within the
`sheath and over the core and rings. A proximal handle of the
`system has a ?rst portion that supports the sheath and a
`second portion that supports the core for relative displace
`ment of the core and the sheath. Retraction of the sheath
`relative to the core uncovers the stent engaged by the rings
`which tends to remain stationary relative to the core so that
`upon partial retraction of the sheath a distal end of the stent
`expands to its expanded form. Further retraction of the
`sheath deploys the stent, retracting the core returns the distal
`portion of the stent into the sheath.
`
`606/108
`
`23 Claims, 3 Drawing Sheets
`
`Umted States P 31101111 [19]
`Ravenscroft
`
`[54] STENT DELIVERY SYSTEM
`
`Invcntor;
`
`Mass_
`
`C. Ravemcrolt Lower Mills’
`
`[73] ASSigllCCi 113108“!!! Scienti?c Corporation, Natick,
`ass.
`
`[211 API>1-I‘I°-=526¢"68
`-
`.
`[22] Flled' 6 Sep' 12’ 1995
`[51] Int. Cl. .
`[52] US. Cl.
`
`A6115 17/60
`606/198; 623/1; 623/12;
`606/108
`606/1, 108, 191,
`[58] Field of Search
`606/192, 194, 195, 158, 200; 623/1, 12;
`128/4, 6, 898, 899; 604/164
`
`[55]
`
`References Cited
`“TENT Cm ‘ENT
`US’ P
`DO
`S
`4,553,545 11/1985 Maass et a1. .
`4,530,563
`4/1936 Gimmmo -
`4,655,771
`4/1937 walls“ ~
`‘£681,110 7/1987 Wm“ '
`4,732,152
`3/1988 Wallsten et a1. .
`4,733,665
`3/1988 Palmaz .
`4,875,480 10/1989 Imbert .
`4,907,336
`3/1990 Gianmo _
`4,950,227
`8/1990 Savin et al. .
`4,990,151
`211991 Wallsten
`
`15
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1017 - Page 1
`
`

`

`US. Patent
`
`Dec. 30, 1997
`
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`
`5,702,418
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1017 - Page 2
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`

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`US. Patent
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1017 - Page 3
`
`

`

`US. Patent
`
`Dec. 30, 1997
`
`Sheet 3 of 3
`
`5,702,418
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1017 - Page 4
`
`

`

`5,702,418
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`1
`STENT DELIVERY SYSTEM
`
`BACKGROUND OF THE INVENTION
`
`2
`
`(1986)
`(1987)
`(1987)
`(1988)
`(1991)
`
`Gianturco
`Wallsten
`Wiktw
`Wallsten a a1.
`am et a.
`
`4,580,568
`4,655,771
`4,681,110
`4,132,152
`5,026,377
`
`15
`
`35
`
`U.S. Pat. No. 4,580,568 to Gianturco discloses a system
`for delivering a self-expanding stent. The system comprises
`a tubular sheath positioned with a distal end proximate a
`selected delivery site. The stent is then compressed and
`inserted into a proximal end of the sheath. A user inserts a
`pusherrod into the tubular sheath and urges the stent through
`the sheath to a position proximate the distal end of the
`tubular member. The user then retracts the sheath relative to
`the push rod to release the stent.
`U.S. Pat. No. 4,655,771 to Wallsten discloses a delivery
`system for a stent that includes a catheter that supports a
`tubular stent in a compact form on its exterior distal end
`surface. Gripper members proximate the proximal and distal
`ends of the tubular stent secure to the catheter. A handle at
`the proximal end of the tubular part of the apparatus enables
`a user to control the axial movement of the gripper members.
`That is, axial displacement of the gripper members by the
`control mechanisms frees the stent from the outer surface of
`the catheter and enables expansion of the stent.
`U.S. Pat. No. 4,681,110 to Wiktor discloses a catheter
`arrangement in which a tubular member contains a radially
`expandable liner and a deployment mechanism for deploy
`ing the liner. The deployment mechanism includes an inter
`nal tube that extends through the outer portion of the tube
`and engages a proximal end of the liner. Distal displacement
`of the inner tube relative to the outer tube urges the liner
`distally of the distal end of the outer tube enables the liner
`to deploy in its radially expanded form.
`U.S. Pat. No. 4,732,152 to Wallsten et al. discloses a
`device and method for implantation of a prosthetic stent. The
`stent is maintained in a compact state within the device
`during transport to a selected location within a patient’s
`vessels and then is released to expand and ?x in a patient’s
`vessel.
`The following United States Letters Patent illustrate prior
`art stent delivery systems for mechanically expansive stents:
`
`1. Field of the Invention
`This invention relates to a percantaneous and endoscopic
`delivery of a stent in a patient’s body and more particularly
`to a stent delivery system including a catheter for the
`selective deployment of an expandable stent.
`2. Description of Related Art
`Stents are well known endoprostheses. A typical
`endoprosthetic stent comprises a tubular structure that
`expands radially from a compact form for transit to an
`expanded form for implantation. Radial expansion causes
`the stent to implant into the tissues of a wall of a “vessel”
`being repaired or bridged to maintain its patency. Such stents
`may be utilized in body canals, blood vessels, ducts and
`other body passages, and the term “vessel” is meant to
`include all such passages.
`Stents can be characterized as self-expansive and
`mechanically expansive. This invention relates to both self
`expansive and mechanically expansive stents further char
`acterized by being formed of a single wire or plurality of
`wires woven together to form a mesh structure which can be
`located on or in a distal end of a tubular body, such as a
`medical catheter, in such compact form. A delivery system
`for such stent comprises a catheter with various associated
`control apparatus extending from a distal end to a proximal
`end. Such a delivery system enables a surgeon to guide the
`distal end with the compact stent to a selected location in a
`patient’s vessel. The surgeon then operates the control
`apparatus to release and expand the stent so as to deploy and
`?x the stent in the selected location. The control apparatus
`may be integral with the catheter for a mechanically expand
`able stent or ancillary to the catheter for a self-expansive
`stent. In either version, the control apparatus releases the
`stent from the catheter and, in the case of a mechanically
`expansive stent, expands the stent radially. After the stent
`has expanded, the surgeon returns the catheter typically to its
`pre-deployment form, free from the stent, and then removes
`the catheter from the patient. The expanded stent remains in
`the vessel in its expanded shape to maintain vessel patency.
`Stent delivery systems must generally conform to several
`important
`First, it is critical in most applications to
`keep the transverse dimension of the delivery system to a
`as the distal end of the delivery system typically
`must be navigated through and along a patient’s lumens
`either in a percantaneous insertion procedure or through the
`working channel of an endoscope. Second, the delivery
`system must facilitate the deployment of the stent into
`contact with the patient's vessel walls once it is located at a
`selected site. Third, the stent delivery system must easily
`disengage from the stent after deployment to enable sepa
`ration of the delivery system from the deployed stent.
`Forn'th, the procedure for removing the delivery system from
`the body must be straightforward and relatively simple to
`speed and ease the work of a physician employing the stent
`delivery system. Fifth, the stent delivery system must be
`reliable and e?icient to reduce trauma and patient risk. Sixth,
`preferably the delivery system should also enable partial
`deployment and retraction of the stent to enable the surgeon
`to recover a stent not properly positioned during deployment
`thereof.
`The prior art stent delivery systems for self-expansive
`endoprosthetic stents are illustrated by the following United
`States Letters Patent:
`
`45
`
`65
`
`4,553,545
`4,733,665
`4,907,336
`4,950,221
`5,026,311
`
`(1985)
`(1988)
`(1990)
`(1990)
`(1991)
`
`Mans 61 all.
`Palmaz
`Giantmco
`Savin a a1.
`am er al.
`
`U.S. Pat. No. 4,553,545 to Maass et a1. discloses a coil
`spring stent and an instrument for transporting the stent in a
`compact form and then deploying the stent in an expanded
`form within a patient’s body. A tubular body carried on the
`distal end of a catheter underlies and supports the stent
`Proximal and distal ends of the stent are clamped between
`the ends of the tubular body and enlarged ?rst and second
`end sections of the catheter. The end sections conned by ?rst
`and second portions of a coaxial cable to a knob member at
`a proximal end of the instrument. A second knob member at
`the proximal end connects with the tubular body so that
`relative rotation of the knobs in a ?rst sense urges rotation
`of the tubular body relative to the end section to urge radial
`expansion of the stent thereby. Opposite rotation of the
`knobs tend to contract the stent. Successive opposed relative
`axial displacement of the knobs successively widens the
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1017 - Page 5
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`

`

`5,702,418
`
`3
`space between the ?rst and second end sections respectively
`and the tubular body to thereby release the stent from the
`tubular member.
`US. Pat. No. 4,733,665 to Palmaz and US. Pat. No.
`4,907,336 to Gianturco disclose a stent delivery system with
`a mesh and wire stent respectively, mounted on an expand
`able balloon at a distal end of the catheter. A surgeon
`positions the distal end of the catheter in a patient's vessel
`and expands the balloon and stent into contact with the
`vessel wall. Then the surgeon de?ates the balloon and
`removes the catheter.
`In US. Pat. No. 4,950,227 to Savin et al. a stent is placed
`at a distal end of a catheter surrounding an expandable
`balloon. Proximal and distal ends of the stent underlie ?aps
`on the outer surface of the catheter. Expansion of the balloon
`releases the stent from the ?aps and expands the stent into
`its operative expanded form.
`In US. Pat. No. 5,026,377 to Burton et al. an outer sheath
`overlies a stent carried in a compact form at the extreme
`distal end of the catheter. An elongated gripping member
`supported by an inner core fridionally grips the stent in its
`compact form. Manipulation of a proximal handle member
`seleaively retracts the sheath to expose the self-expanding
`stent and enables deployment at the select location. At an
`intermediate position a physician can selectively retract the
`inner core to retract the stent within the out: sheath.
`Burton et al. do provide apparatus that enables a surgeon
`to retract a stent after displacement has begun. However,
`Burton et al. do not provide any indication that the stent has
`deployed beyond a point at which retraction is no longer
`possible. That is, Burton et al. fail to disclose apparatus
`enabling a surgeon to determine when the axial forces
`necessary to reduce the expanded portion of the stent have
`exceeded the frictional bond between the stent and a grip
`ping surface that retains the stent on the catheter.
`Furthermore, in the prior art, such as that disclosed by
`Burton et al., the stent in its compact form is closely
`proximate both a core and an outer sheath. The inner stent
`surface bears on the core and the outer stent surface bears on
`the inner sheath surface to thereby form a frictional engage
`ment therebetween. This also reduces the overall ?exibility
`of the distal end of the stent delivery system Maneuvering
`a distal end of reduced ?exibility though the tortious paths
`often encountered in a patient's vessels can increase patient
`trauma and can, in some cases, make this treatment modality
`impracticable. Thus, a surgeon frequently faces the decision
`of risking additional trauma to the patient or adopting
`another procedure for treating the patient. Thus. none of
`these prior art delivery systems and methods enable the
`delivery of a stent to a selected location of patient’s body
`and facilitate the retraction of a partially deployed stent, that
`provides reasonable ?exibility of the distal end for position
`ing the stent at the selected location and that provides to a
`physician a de?ned zone of retractability of the stent.
`
`25
`
`30
`
`35
`
`45
`
`55
`
`4
`retraction of the stent characterized by a ?exible distal end
`for use in percantaneous and endoscopic procedures and
`adapted for passage through tortious paths de?ned by the
`vessels of a patient.
`It is yet another object of this invention to provide a
`method and system for delivery of a stent which reduces the
`steps and time necessary to deliver a stent to a selected
`location of a vessel in a patient.
`It is yet still another object of this invention to provide a
`method and system for delivery of a stent which enables a
`user to ascertain whether the stent is retractable.
`It is a further object of this invention to provide a method
`and system for delivery of a stent which is relatively simple
`and inexpensive to produce and use.
`In accordance with one asped of this invention a delivery
`system for positioning a stent in a patient’s vessel includes
`a catheter for positioning the stent at a predetermined
`position in the patient’ s body. The catheter includes a sheath
`normally overlying the stent in its compact form and an
`inner core normally underlying the stent in its compact
`transport form. Two spaced rings extend radially from the
`inner core and engage the stent in its compad form to enable
`deployment of the stent by distal displacement thereof
`relative to the sheath and retraction of the stent within the
`sheath by proximal displacement thereof relative to the
`sheath.
`According to another aspect of this invention a delivery
`system includes a distal end having a ?exible sheath and a
`?exible core at a distal end of, the system for overlying and
`underlying, respectively, a self-expansible stent positionable
`in a compact form. The stent is supported on at least two
`spaced rings secured to the core. Retracting the sheath
`relative to the core deploys the stent; retraction of the core
`relative to the sheath prior to full deployment of the stent
`retracts the stent relative to the sheath.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`The appended claims particularly point out and distinctly
`claim the subject matter of this invention. The various
`objects, advantages and novel features of this invention will
`be more fully apparent from a reading of the following
`detailed description in conjunction with the accompanying
`drawings in which like reference numerals refer to like parts,
`and in which:
`FIG. 1 is a plan view in partial cross-section illustrating
`an embodiment of a stent delivery system according to this
`invention;
`FIG. 2 is an enlarged view of a distal end of the embodi
`ment of FIG. 1;
`FIG. 3 is a sectional view taken along the line 3—3 in
`FIG. 2;
`FIG. 4 is a plan view of the embodiment of FIG. 1 with
`the stent in a partially deployed position;
`FIG. 5 is a plan view of the embodiment of FIG. 1 with
`the stent in a fully deployed position;
`FIG. 6 is an enlarged plan view similar to FIG. 1 of
`another embodiment of this invention; and
`FIG. 7 is a plan view similar to FIG. I of yet another
`embodiment of this invention particularly useful in deploy
`ing a non-self-expanding stent.
`
`65
`
`DESCRIPTION OF ILLUSTRATIVE
`EMBODIMENTS
`A stent delivery system 10 according to this invention as
`depicted in FIG. 1 includes a elongated catheter 11 defined
`
`SUMMARY
`Therefore. it is an object of this invention to provide a
`method and system for either pucantaneous or endoscopic
`delivery of a stent at a selected location in a vessel of a
`patient.
`It is another object of this invention to provide a stent
`delivery system with a ?exible distal end adapted for pas
`sage through the vessels of a patient and with the capability
`of selective deployment and retraction of the stent.
`It is still another object of this invention to provide a stent
`delivery system with capability of selective deployment and
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1017 - Page 6
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`5,702,418
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`6
`
`5
`between a proximal handle 12 and a distal end tip 13. An
`axially extending plastic core 14 supports the distal end tip
`13. The core 14 includes a relatively stiif portion 15 extend
`ing distally from the handle 12. A ?exible thick portion 16
`extends distally from the stiif portion 15. A ?exible thin
`distal portion 17 extends between the portion 16 and the
`distal end tip 13. The ?exible thin portion 17 underlies a
`mesh stent 20 supported in a compacted form within the
`catheter 11 proximate the distal end tip 13 for deployment
`from the catheter 11 in an expanded form within a patient’s
`vessel 22.
`First and second closely. but axially spaced rings 23 attach
`to the thin portion 17 to be intermediate the portion 17 and
`the stent 20 to engage the stent 20. A slippery outer sheath
`24, preferably formed of a radially ?exible axially still~
`material such as polytetra?uoroethylene or other like
`material, overlies the stent 20 and extends proximally to a
`?rst handle portion 25. The stiff portion 15 of the core 14
`secures to a second handle portion 26. The handle portions
`25 and 26 are displaceable along the axis 27 relative to each
`other thereby to enable selective deployment and retraction
`of the stent 20.
`In the embodiment of FIG. 1, the stiff portion 15 of the
`core 14, which extends a substantial length of the catheter
`11, is preferably formed of a plastic material such as
`PEBAX® or an elongated coiled spring formed of plastic or
`metal such as Nitinol® which provides limited ?exibility so
`the catheter 11 can readily be pushed from the handle 12
`through the patient’s vessel with little risk of kinln'ng. The
`core portions 16 and 17 are relatively ?exible radially.
`The presence of the stent 20 on the axially spaced rings 22
`does not signi?cantly retard the overall ?exibility of the
`extreme distal end of the catheter 11, because the rings 23
`which support the stent 20 are substantially spaced from the
`distal end tip 13. That is, the distal portion of the stent 20
`?oats in a radial sense over the core 17. Thus upon appli
`cation of a radially directed force to the sheath 24 proximate
`the distal end tip 13, the stent 20 tends to radially displace
`within the sheath 24 thm'eat. This feature eases the surgeon’s
`task in navigating the catheter 11 through severely tortious
`paths often associated with both endoscopic and percanta
`neous procedures. Thus, employment of this invention
`reduces the steps and time necessary for delivery of a stent
`to a delivery site.
`Once the system 10 is properly inserted, the distal end tip
`13 will be positioned at a selected location in a patient’s
`vessel 22 for deployment of the stent 20. This can be
`accomplished by various means, preferably by providing
`markers such as radiopaque rings or indicia 37 on the core
`17 proximate the distal end tip 15 to properly locate the
`system 10. Then a surgeon will operate the handle 12 to
`deploy the stent 20.
`As best seen in FIGS. 2 and 3, the stent 20 preferably
`comprises a plurality of interlocking loops 20A having
`spaced overlapping portions 20B and single wire portions
`20C intermediate thereof. The individual wires preferably
`have a diameter “D,,”, the rings 23 have an outer diameter
`“D,”, and the sheath 24 has an inner diameter “D,”, wherein:
`
`10
`
`15
`
`35
`
`45
`
`55
`
`The outer diameter “D,” of the rings 23 therefore is
`preferably between the maximum and minimum inner diam
`eters of the stent 20 in its compact form. Thus, as depicted
`in FIG. 1, the stent 20 is positioned within the sheath 24 with
`the single wire portions 20C overlying the rings 23 and the
`ovm'lapping portions 208 disposed between adjacent rings
`23. Thus, upon distal displacement of the rings 23 distal
`faces of the rings 23 engage proximal surfaces of distally
`adjacent overlapping portions 2013 to urge corresponding
`distal displacement of the stent 20. Likewise upon proximal
`displacement of the rings 23 proximal faces of the rings 23
`engage distal surfaces of proxirnally adjacent overlapping
`portions 2013 to urge corresponding proximal displacement
`of the stent 20. As will now be appreciated the positive
`engagement between the stent 20 and the rings 23 due to the
`interspersed portions of the stent having large and small
`inner diameters, IBM and 1D,“, enable the selective and
`relatively sure control of the surgeon in deploying and
`retracting the stent 20.
`In the embodiment of this invention illustrated by FIG. 1,
`the surgeon preferably grasps the handle portion 25 and the
`handle portion 26 with two hands, holds the handle portion
`26 steady and retracts the handle portion 25. This retracts the
`sheath 24 relative to the core 14. When the surgeon partially
`retracts the sheath to a position as shown in FIG. 4, the distal
`portion of the stent 20 beyond the sheath expands. The
`surgeon can uses ?uoroscopic or endoscopic viewing tech
`niques and apparatus to determine whether the stent 20 is
`appropriately positioned. 1f the stent 20 is not properly
`positioned the surgeon displaces the handle portion 26
`proximally to retract the core 14, attached rings 23 and the
`stent 20 fully within the sheath 24 so that the stent 20 and
`delivery system returns to the condition as depicted in FIG.
`1. The distal end can then be maneuvered to a desired
`location or into a desired orientation and the process
`repeated. Once the surgeon is satis?ed with the location and
`orientation of the partially deployed stent 20, the surgeon
`merely fully retracts the handle 25 to fully deploy the stent
`20 as depicted in FIG. 5.
`Those skilled in the art will now recognize that the ability
`to retract a partially deployed stent enables a surgeon to
`ascertain whether the stent 20 is properly positioned ?uo
`roscopically and/or visually through an endoscope before
`fully deploying the stent 20. This can be important to both
`surgeon and patient as improper positioning can increase the
`trauma and risk to a patient and curtail the e?iciency of the
`treatment. As is known, manipulation of handles at the
`proximal end of a catheter to deploy a stent often affects the
`site of deployment of the stent as the distal end of the
`catheter can be unintentionally translated by such manipu
`lation. likewise other factors, some of which are only
`apparent upon deploying the stent can render a location
`initially thougrt to be inappropriate. For these reasons, the
`embodiment of FIG. 1 includes the indicia 37 thereon, so
`that a surgeon using a ?uoroscope or viewing channel of an
`endoscope can ascertain the extent of deployment of the
`stent 20, as more fully discussed below.
`FIG. 6 depicts another embodiment of this invention. A
`single ring 23‘ mounts to the catheter. It has a slightly longer
`axial extension than each ring 23. but less than the axial
`distance between the interlocking loops 20A. The ring 23‘
`has an outer diameter (D,'). that satis?es the conditions:
`
`(1)
`Likewise the stent 20 when in its compact form has an outer
`diameter approximately "D,” and maximum inner diameter
`(mm) and minimum inner diameter (mm) where:
`
`lbw-0,41),
`
`and
`
`65
`
`(2)
`
`The operation and use of this embodiment is similarly
`identical to the embodiment of FIG. 1.
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1017 - Page 7
`
`

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`5,702,418
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`25
`
`30
`
`35
`
`7
`Referring now to FIG. 7, another delivery system 47
`according to this invention includes the annular rings 23"
`that support a stent 50 in a compact form. The stent 50,
`rather than being a self-expanding stent, is formed with a
`known material de?ning the mechanically expansible mesh
`that locks in an expanded form. The annular rings 23"
`engage the stent 50 in its compact form to enable retraction
`of the stent 50 by retraction of the handle portion 26 and to
`prevent retraction of the stent 50 when the sheath 24 is
`retracted by operation of the handle 25. In this embodiment,
`a balloon lumen (not shown) connects to an expansible
`balloon 60 that underlies the stent 50 between proximal to
`distal ends 58 and 59. The balloon 60 also lies between the
`rings 23 and the stent 50. If the sheath 24 is partially
`retracted to a position similar to that of FIG. 2, in?ating the
`balloon 60 expands only the exposed portion of the balloon
`60 and the coextensive portion of the stent 50 that lies
`distally of the sheath 24.
`If repositioning of the stent is required, the surgeon
`de?ates the balloon 60 and retracts the core portion 17 to
`thereby contract the stent 50 to enable repositioning of the
`distal end of the system 47. In this embodiment an extreme
`distal end of the sheath 24 preferably includes an integral
`metal or hard plastic ring 61 to assist in the compression of
`the stent 50 upon retraction thereof from is partially
`deployed condition. Once the stent 50 is partially deployed
`in a satisfactory position, the surgeon fully retracts the
`sheath 24 and fully in?ate the balloon 60 to fully deploy the
`stent 50 thereat.
`As previously indicated. the particular structures of the
`stent delivery systems according to this invention are suited
`for use in procedures using either percantaneous or endo
`scopic insertion techniques. In an endoscopic insertion tech
`nique the surgeon inserts the catheter 11 through the working
`channel 70 of an endoscopic device 71 (see FIG. 5). In eithm'
`technique a central lumen such as lumen 30 in FIG. 4, can
`extend through the catheter 11 receive a guidewire 31. With
`the central lumen 30, the surgeon can ?rst position the
`guidewire 31 in the patient and then slide the catheter 11
`over the guidewire 31 to position the catheter 11 within the
`patient’s vessels with relative ease.
`In accordance with another aspect of this invention, the
`distal end tip 13 can be formed of a radiopaque material or
`provided with a radiopaque marker to improve ?uoroscopic
`observation of the distal end of the systems 10 and 47 of
`FIGS. 1 and 7. The core portion 17 and the extreme distal
`end 61 of the sheath 24 can also be provided with indicia 37
`to indicate extension of the core 17 relative to the sheath.
`'Ihe indicia 37 and 61 will generally be radiopaque indicia
`although in devices according to this invention used with an
`endoscope 71 having a viewing channel 73, the indicia 37
`and 61 may be of a type only visually perceived (e. g. colored
`rings). Preferably the indicia 37 is arranged in a selected
`number; concentration and/or color to indicate when the
`degree of deployment has reached a state where further
`distal displacement of the rings will render subsequent
`retraction of the stent impossible. Thus, a surgeon upon
`observing the selected indicia 37 that the commitment to
`deploy or retract must be made.
`Thus, the stent delivery system of this invention enables
`a surgeon to position a compacted stent at a selected location
`and partially deploy the stent, then either fully deploy the
`stent or return the stent to its compacted form. A surgeon
`after partially deploying a stent can, upon observing a
`problem such as incorrect positioning or the like, retract the
`stent within the sheath 24 and then reposition the distal end
`13 at a selected location and commence deployment of the
`
`8
`stent. The use of one or more of the rings 23, 23‘ or 23" also
`tends to improve the radial ?exibility of the distal end of the
`stent delivery systems according to this invention as com
`pared with such prior art systems. As should now be
`understood, the rings 23, 23' and 23" disclosed herein are
`structures that interlock with the stent when in its compact
`form. This interlocking provides the improved control of the
`stent in deploying and retracting the stent relative to the
`catheter.
`This invention has been disclosed in terms of certain
`embodiments. It will be apparent that many modi?cations
`can be made to the disclosed apparatus without departing
`from the invention. By way of example, additional rings to
`engage the stent may be employed, the rings or rings used
`may included slots for receiving portions of the stent over
`lying the rings, and, in fact, a ring can be formed or de?ned
`by a plurality of protuberances or fingers that extend from a
`core or similar structure to engage and interlock with
`portions of the stent with the minimum inner diameter.
`Therefore, it is the intent of the appended claims to cover all
`such variations and modi?cations as come within the true
`spirit and scope of this invention.
`What is claimed as new and desired to be secured by
`Letters Patent of the United States is:
`LA stent delivery system for transporting and deploying
`an expansible stent, said stent delivery system comprising:
`A) delivery means for positioning the stent at a selected
`position in the patient’s body, said delivery means
`, including a sheath normally overlying the stent in its
`compact transport form and an innm' core having a
`surface normally underlying the stent in its compact
`transport form, and
`B) deployment means for selectively deploying and
`retracting the stent relative to said sheath, said deploy
`ment means including a ring attached to and extending
`radially from the surface of said inner core to be
`intermediate the inner core and the stent for engaging
`the stent in its compact condition.
`2. A stent delivery system as recited in claim 1 wherein the
`outer diameter of said ring is greater than the minimum inner
`diameter of the stent in its compacted form.
`3. A stent delivery system as recited in claim 2 wherein
`said ring engages the stent proximate a proximal end of the
`stent in its compacted delivery state.
`4. A stent delivery system as recited in 3 wherein said
`delivery means further includes a handle disposed at a
`proximal end of said sheath and said inner core. said handle
`having a ?rst actuator means for proximally retracting said
`sheath relative to said inner core and second actuator means
`for distally displacing said inner core relative to said sheath,
`such that selective manipulation of said ?rst and second
`actuator means enables selective deployment of the stent in
`an expanded form outside of said sheath and retraction of the
`stent within said sheath from a partially deployed state.
`5. A stent delivery system as recited in claim 1 wherein
`said delivery system is adapted for use in the working
`channel of an endoscopic device of the type having a
`viewing channel, said catheter including visible indicia
`proximate its distal end visible through the viewing channel
`of the endoscopic device indicating the extent of deployment
`of the stent.
`6. A stent delivery system as recited in claim 5 wherein
`said delivery means further includes a handle disposed at a
`proximal end of said sheath and said inner core, said handle
`having a ?rst actuator means for proximally retracting said
`sheath relative to said inner core and second actuator means
`for distally displacing said inner core relative to said sheath,
`
`45
`
`50
`
`55
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`65
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1017 - Page 8
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`5,702,418
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`9
`such that manipulation of said ?rst and second actuator
`means enables selective deployment of the stent in an
`expanded form outside of said sheath and retraction of the
`stent in the compact form within said sheath.
`7. A stent delivery system as recited in claim 1 further
`comprising a second ring axially spaced ?'om said ?rst ring,
`said ?rst and second rings engaging the stent proxinmte a
`proximal end of the stent in its compacted delivery state.
`8. A stent delivery system as recited in claim 7 wherein
`said delivery means further includes a handle disposed at a
`proximal end of said sheath and said inner core, said handle
`h