5,026,377
`(11) Patent Number:
`115)
`United States Patent
`
` Burtonetal. [45] Date of Patent: Jun. 25, 1991
`
`
`(54) STENT PLACEMENT INSTRUMENT AND
`METHOD
`
`[75]
`
`Inventors:
`
`John H. Burton; Bradford G.Staehle,
`both of Minnetonka, Minn.
`.
`.
`.
`[73] Assignee: American Medical Systems, Inc.,
`Minnetonka, Minn.
`[21] Appl. No.: 569,267
`{22] Filed:
`Aug. 17, 1990
`
`4,580,568 4/1986 Gianturco .
`4,655,771
`4/1987 Wallsten .
`4,681,110
`7/1987 Wiktor .
`4,732,152
`3/1988 Wallsten et al. sess 606/108
`4,733,665
`3/1988 Palmaz .......sceeeeeereseeeenees 606/108
`4,768,507
`9/1988 Fischell et al.
`.
`4,830,003
`5/1989 Wolff et ab. escscsssssensenee 606/191
`4,913,141
`4/1990 Hillstead ....-.ecsssseeaeseun 606/108
`Primary Examiner—Michael H. Thaler
`Attorney, Agent, or Firm—Peter C. Richardson;
`Lawrence C. Akers; Mark Dryer
`
`
`
`ABSTRACT
`[57]
`Related U.S, Application Data
`[63] Continuation of Ser. No. 379,458, Jul. 13, 1989, aban-=An instrument for the deployment or retraction of a
`doned.
`self-expanding stent in a body canal, which comprises
`[ST] Unt. C15cececcceeesnseneneeeesseeennenensees A61B 17/00
`an elongated tubular outer sleeve having disposed
`[52] US. C1. oeeecssescsesseseesensnesenseneneeenenerens 606/108
`therein an elongated core which is movablerelative to
`{58] Field of Search................ 606/108, 198, 200, 191
`said sleeve and has a grip member formedat ornearits
`[56]
`References Cited
`distal end, which grip memberis adapted to releasably
`hold a self-expanding stent within said outer sleeve.
`U.S. PATENT DOCUMENTS
`4,553,545 11/1985 Maass et al. oo...cece 606/198
`
`24 Claims, 2 Drawing Sheets
`
`
`
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1014 - Page 1
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1014 - Page 1
`
`

`

`U.S. Patent
`
`June 25, 1991
`
`Sheet 1 of 2
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`5,026,377
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`Petitioner Edwards Lifesciences Corporation- Exhibit 1014 - Page 2
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1014 - Page 2
`
`

`

`U.S. Patent
`
`June 25, 1991
`
`Sheet 2 of 2
`
`5,026,377
`
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1014 - Page 3
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1014 - Page 3
`
`
`
`
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`

`

`1
`
`5,026,377
`
`STENT PLACEMENT INSTRUMENT AND
`METHOD
`
`This is a continuation of application Ser. No. 379,458,
`filed on July 13, 1989 abandoned.
`BACKGROUNDOF THE INVENTION
`
`2
`hose or outer sheath requires to be inflated with a pres-
`surized fluid makes the device cumbersome and awk-
`ward to operate.
`It has now been found that a self-expanding braided
`stent, such as that disclosed in U.S. Pat. No. 4,665,771,
`may be not only deployed into a body canal but also
`retracted back into the outer sleeve of a placement
`instrument which is simple, reliable and inexpensive if
`said instrument has the configuration and features as
`hereinafter described.
`
`This invention relates to an instrument for the place-
`ment of a stent in a body canal and particularly to an
`instrument for the deployment or retraction of a self-
`expanding stent.
`In accordance with the present invention there is
`Tubular prostheses for transluminal implantation in
`provided an instrument for the deployment or retrac-
`body canals, for example blood vessels, for the purpose
`tion of a self-expanding braided stent in a body canal,
`ofrepair or dilation are knownin the art. These prosthe-
`which comprises an elongated tubular outer sleeve hav-
`ses, referred to herein as stents, may be tubular elements
`ing a proximal end and a distal end, an elongated core
`which are non-extendible or extendible (i.e. adapted to
`disposed within said sleeve and movable relative to said
`extend longitudinally), or they maybeself-expanding in
`sleeve, said core being longer than said sleeve and hav-
`the transverse direction.
`ing a proximal end andadistal end and including a grip
`A typical self-expanding stent is disclosed in U.S.Pat.
`memberat or near said distal end of the core, said grip
`No. 4,665,771, which stent has a radially and axially
`memberbeing an integra! portion of the core or a sleeve
`flexible, elastic tubular body with a predetermined di-
`or coating attached around the periphery of the core
`ameterthat is variable under axial movementof ends of
`and being adaptedto: (i) releasably hold a self-expand-
`the body relative to each other and which is composed
`ing stent within said outer sleeve, there being sufficient
`ofa plurality of individually rigid but flexible and elastic
`clearance between said grip member and said outer
`thread elements defining a radially self-expanding helix.
`sleeve to accommodatesaid stent without distortion,(ii)
`This type of stent is known in the art as a “braided
`deploy said stent beyond the distal end of said outer
`stent” and is so designated herein. The disclosure in
`sleeve when said outer sleeve is moved in a backward
`U.S. Pat. No. 4,665,771 is incorporated herein byrefer-
`ence.
`.
`direction relative to said core and(iii) retract said stent
`back within said outer sleeve whensaid core is pulled in
`Placement of the stent according to U.S. Pat. No.
`a backward direction relative to said outer sleeve.
`4,665,771 in a body vessel is achieved in one embodi-
`The invention also provides a method for the deploy-
`ment by a device which comprisestheuseof a pistonor,
`mentof a self-expanding braided stent in a body canal,
`in another embodiment, by use of.latch means to push
`wherein said stent is pre-located on a grip memberof a
`the stent forward.
`core within an outer sleeve of an instrument as de-
`U.S. Pat. No. 4,768,507 discloses a stent insertion
`scribed above so that the inner surface of the stent is
`apparatus which includes an inner core member with a
`releasably held by the outer contact surface ofsaid grip
`spiral groove formedonits outer surface, which groove
`member, which method comprises passing said instru-
`cooperates with an outer sheathing to forma spiral
`ment into the body canal until it reaches a position for
`cavity adapted to contain an expandable coil stent. The
`proper placementof the stent and deploying the stent at
`coil stent is held in a radially compressed state within
`said position by moving the outer sleeve proximally
`said spiral cavity by exerting a radial outward force on
`relative to the core, and withdrawing said instrument
`the outer sheath. The outer surface of the inner core
`when the stent is properly located at the desired posi-
`memberis slidably mounted within the hollow outer
`tion in the body canal.
`sheath cylinder so that the spiral cavity is adapted to
`contain only the coil stent for which it is designed. U.S.
`DETAILED DESCRIPTION OF THE
`Pat. No. 4,743,152 discloses a device for implantation of
`INVENTION
`a substantially tubular, radially expandable prosthesis
`The type of stent to be deployed or retracted by an
`including in combination said radially expandable pros-
`instrument according to the invention is preferably a
`thesis surrounding and concentric with a flexible probe
`self-expanding braided stent such as that disclosed and
`and means for maintaining said prosthesis in a radially
`illustrated in U.S. Pat. No. 4,655,771 and the invention
`contracted state and for releasing said expandable pros-
`will be particularly described hereinafter with reference
`thesis, wherein said means for maintaining and releasing
`to such a stent. However,it is to be understood that the
`the prosthesis comprises a hose concentrically sur-
`instrument according to the invention may be used for
`rounding said probe with one end of said hose being
`the placementof any expansible stent having a configu-
`connected to the probe, the hose being folded inside
`ration and dimensions which enable it to be releasably
`itself, a double-walled section of said hose formed by
`held between the grip member and outer sleeve of said
`said hose being folded insideitself, said double-walled
`instrument.
`section radially surrounding theprosthesis, a fluid-tight
`In a preferred embodimentof the invention the core
`chamber provided between and defined by said probe
`is hollow andthis feature assists in the proper position-
`and said hose, meansfor introducing and pressurizing a
`ing of the instrumentin a body canal. Thusit is possible
`fluid in said chamber to reduce contact pressure and
`to pass a guide wire into and along the body canal and
`friction between said double-walled section of the hose,
`pass the instrument over the guide wire until it is prop-
`the prosthesis being released from the hose by axial
`erly positioned in the body canal. In this embodiment
`relative movement of said one end of the hose with
`the instrument includes an elongated, flexible, steerable
`respect to an opposite end of said hose, said opposite
`guide wire located within and alongthe axis of the core.
`end of said hose connected to an element ofsaid device.
`Whenthe instrumentis positioned in the body canal the
`The requirement that a chamber formed by a folded
`
`SUMMARYOF THE INVENTION
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`3
`guide wire mayberetained within the instrument until
`the stent is deployed at the desired location and with-
`drawn together with the instrumentor, alternatively the
`guide wire may be withdrawn prior to deployment of
`the stent so that correct positioning of the stent, while
`still within the instrument, maybeverified, for example,
`by endoscopic or fluoroscopic means.
`To facilitate movement of the core relative to the
`outer sleeve, the core preferably has a handle attached
`to its proximal end and the proximal end of the outer
`sleeve preferably terminates in a flange or handle.
`It is to be understood that, as used herein, the term
`“proximal” means the end or part nearest to the opera-
`tor of the instrument and the term “distal” means the
`end or part furthest from the operator. Thus the front
`end of the instrument which enters the body canalis the
`distal end.
`The mostsignificant feature of the instrument accord-
`ing to the invention is the grip member and the signifi-
`cance ofthis feature is that it enables both deployment
`and retraction of the stent. In particular, the grip mem-
`beris directly associated or integral with the core and is
`adaptedto releasably hold a self-expanding stent within
`the outer sleeve. Thus, the grip member maybe a sleeve
`or coating attached aroundthe peripheryof the core, an
`integral portion of the core or a length of the core hav-
`ing a larger outer diameter than the remainder of the
`core.
`in
`Preferred embodiments include an instrument
`which the grip memberis a sleeve of material with a
`friction contact surface or a sleeve of material that will
`take a set, for example a silicone rubber or a polyure-
`thane. In each of these embodiments the sleeve material
`mayhavean outer surface whichis substantially smooth
`and unbrokenor an outer surface which is roughened or
`irregular. Alternatively, if the core itself is made from a
`material that will take a set the grip member maybe an
`integral portion of the core. An advantage of this em-
`bodimentis that the grip member neednotbe a separate
`element whichhas to be attached or bondedte the core.
`Asused herein the term “friction” or “high friction”
`as applied to a materialor its surface is intended to mean
`a material having a high coefficient of friction, ie. a
`material whose surface offers high resistance to sliding
`motion; and the term “low friction” is intended to mean
`a material with a surface whichofferslittle resistance to
`sliding motion andis relatively slippery.
`Accordingly, since an important characteristic of the
`grip memberis that it should be capable of gripping or
`holding a stent and this capability must be effective
`while the stentis retained within the instrumentso that
`there is no slippage when the core is moved forward or
`backwardrelative to the outer sleeve, it is necessary
`when the grip memberis a sleeve of material, that said
`material has a surface which offers high resistance to
`sliding motion. When the material is one which already
`has a high coefficient of friction the surface thereof
`whichis in contact with the stent may be substantially
`smooth and unbroken. However,to increase the friction
`or enhancethe inherentfriction, the outer surface of the
`grip member maybe roughened orirregular.
`In an alternative embodiment of the invention the
`gripping characteristic of the grip member may be
`achieved when the grip member comprises a coating of
`a releasable adhesive. In this embodimentthe adhesive-
`ness of the coating must be sufficient to retain or grip
`the stent without slipping while it
`is still within the
`instrument but weak enough to allow the stent to be
`
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`5,026,377
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`4
`released, by its own expansion, whenit is free from the
`constraint of the outer sleeve.
`In a further embodiment of the invention the core
`itself is made from a highfriction material, for example,
`a polyurethane, and the grip member comprisesa length
`of said core, at or near the distal end of the core, having
`a larger outer diameter than the remainderofthe core.
`In practice, the enlargement of diameter may berela-
`tively small, of the order of about 0.01 inch, butit has
`been found that mounting the stent on this thicker por-
`tion of the core provides sufficient grip to enable the
`instrument to be operated as desired.
`Whenthe coreitself is made from a material that will
`take a set, such a material being inherently of high fric-
`tion, the larger diameter may not be necessary for the
`formation of the grip member. A ‘material that will
`take a set” is defined herein as a material that will be
`locally deformed in situ by the compression of the stent
`whenit is pressed against the core by the outer sleeve
`and will retain the deformation so that the stentis effec-
`tively gripped thereby.
`In each of the above-described embodiments the grip
`memberpreferably is at least as long as the stent.
`When an expandable stent to be deployed by an in-
`strument according to the invention is made from a
`plurality of cross threads, for example, plastic or metal
`filaments, and particularly metal filaments, such as by
`the braiding operation described in U. S. Pat. No.
`4,655,771, the ends of the stent will have a number of
`exposed filament ends. To avoid snagging of these ex-
`posed ends, for example,
`into the wall of the outer
`sleeve, and to avoid consequential damageeither to the
`outer sleeve or to the stentitself, it is advantageous to
`provide circumferential gaps adjacent the distal end and
`proximal end of the grip member to accommodate the
`respective ends of the stent. In this embodiment the
`endsof the stent tuck into said gaps thereby protecting
`them and preventing exposed filaments from snagging.
`In contrast to the high friction characteristic of the
`gtip memberit is desirable that the inner wall of the
`outer sleeve has a low coefficient offriction to provide
`slidability and ease of movement of the stent-bearing
`grip member within the instrument. To achieve this
`characteristic it is preferable that the outer sleeve is a
`hollow catheter made from a lowfriction material, for
`example, a fluorocarbon polymersuch as polytetrafluo-
`roethylene.
`Furthermore, to avoid the snagging problem men-
`tioned above, it may be advantageous to provide the
`inner surface of the outer sleeve with a layer of hard-
`ened material. Such material also should be a low fric-
`tion material.
`:
`Additionally, when the outer sleeve is made from a
`relatively soft material, the soft distal end thereof may
`have a protective hard hollow cap, for example, made
`of metal, attached thereto.
`To facilitate proper placementof the instrument,it is
`advantageous to include one or more marker elements,
`each located at a predetermined position on the outer
`sleeve or core. In a preferred embodiment, each ofsaid
`marker elements may be a band of metal or radiopaque
`material attached to the periphery of the outer sleeve,
`whereby correct placement of the instrument prior to.
`deployment of the stent may be checked by fluoros-
`copy.
`.
`The above features or any combination thereof may
`be included in the instrument to provide smooth opera-
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1014 - Page 5
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`

`5,026,377
`
`5
`tion, proper placement and avoidance of snagging or
`damageto thestent.
`In order to facilitate passage of the instrument into
`and along a bodycanal it also is advantageous to attach
`a flexible filiform to the distal’ end of the core. This
`embodiment also may avoid the use of a guide wire.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`_
`
`Preferred embodiments of the invention are illus-
`trated in the accompanying drawings in which:
`FIG. 1 is a side elevation, partly in section, of an
`instrument according to the invention;
`FIG.2 is an enlarged side elevation of the distal end
`of an instrument showing a partly deployedstent:
`FIG. 3 is an enlarged cross section of one embodi-
`ment of a grip member;
`FIG. 3A is a cross-section through line 3A—-3A on
`FIG.3.
`FIG. 4 and FIG. 5 are cross-sections of alternative
`grip members; and
`FIG. 6 is a side elevation of part of an instrument
`according to the invention showing other features.
`DESCRIPTION OF PREFERRED
`EMBODIMENTS
`
`6
`its distal end to prevent snagging from the ends of the
`stent 10. Preferably the distal end 16 of the metal rim is
`rounded to facilitate passage along the body canal.
`Additionally, the metal cap may serve as a marker
`elementfor fluoroscopic monitoringof the placement of
`the instrument within the body canal. Additional or
`alternative marker elements 17 may be provided at
`pre-determined positions on the outer sleeve and/or on
`the core (not shown).
`A flexible filiform 18 may be attached to the distal
`end ofthe core 5 to facilitate passage of the instrument
`along a body canal in known manner.
`Deploymentof a stent within a body canal in accor-
`dance with the method of the invention may be per-
`formed by using any of the embodiments illustrated in
`the drawings and described above.
`To perform the method a self-expanding stent is in-
`troduced into the instrument in a manner knownin the
`art and pre-located on the grip member. The grip mem-
`ber bearing the stent is withdrawn into the instrument
`so that the whole ofthe stent is within the outer sleeve,
`close to the distal end thereof, andis constrained by said
`outer sleeve. The instrument containingthe stent is then
`introduced into the body canal, with or without the aid
`of a guide wire, and passed into the canal until it reaches
`a position for proper placementofthe stent. The intro-
`The preferred embodiment of the invention illus-
`duction and passageof the instrument in the body canal
`trated in FIG. 1 of the drawings comprises an outer
`may be facilitated when a filiform is attached to the
`sleeve 1 having an integral handle 2 at its proximal end.
`distal end of the core as described hereinabove.
`The distal end 3 of the outer sleeveis positioned within
`The positioning of the instrument within the body
`a body canal 4. Disposed axially within the outer sleeve
`canal may be monitored and verified by any means
`is a hollow core 5 having a handle6at its proximal end.
`knownin the art, for example, by use of an endoscope
`The distal end 7 of the core has a stepped up diameter
`or by fluoroscopy. Toassist fluoroscopic examination,
`whereit meets the distal end of the outer sleeve so that
`one or more marker elements maybe located at a prede-
`it provides a smooth transition from said end of the
`termined position on the outer sleeve or core as de-
`outer sleeve, and is also within the body canal. A guide
`scribed hereinabove.
`wire.8 passes axially throughthe hollow core. Attached
`When the correct position for proper placement of
`aroundthe peripheryofthe coreatits distal end is a grip
`the stent is reached and verified, the stent is then de-
`member 9 which releasably grips a self-expanding stent
`ployed by moving the outer sleeve relative to the core.
`10, shown here partly deployed at the proper location
`This operation is performed by holding the handle at
`within the body canal.
`the proximal end of the core so that the core, together
`FIG. 2 is an enlarged side elevation showing a
`with the grip member holding the stent, remainsstation-
`braided self-expanding stent 10, partly deployed from
`ary, gripping the handle at the proximalendofthe outer
`the distal end of the outer sleeve 1. This view showsthe
`sleeve and withdrawing the latter towards the core
`exposed ends of the wire filaments 11 which make up
`handle so that the outer sleeve moves backward, thus
`the stent.
`exposing the stent, which, free from the constraint of
`FIGS. 3 and 3Aillustrate a grip member 9 made from
`the outer sleeve, expands to its expanded state. Before
`a high friction material attached around the periphery
`the stent is completely deployed from the instrument,
`of a hollow core 5. The grip memberhas circumferen-
`the positioning thereof in the body canal is checked. If
`tial gaps 12, 13 adjacentits distal end and proximal end,
`the position is correct then the withdrawal of the outer
`respectively, which accommodate the ends 11 of the
`sleeve is continued until the stent is clear of the instru-
`stent, thereby avoiding snagging into the inner wall of
`ment and the instrument is then withdrawn from the
`the outer sleeve.
`body canal. However,if the monitoring reveals that the
`FIG.4 illustrates a grip member 9A which comprises
`stentis not in its proper position then it may be retracted
`a coating of releasable adhesive around the periphery of
`back within the outer sleeve simply by moving the core
`the inner core 5.
`backwardly relative to outer sleeve using the handles on
`FIG.5 illustrates, in cross-section, an embodimentin
`the core and outer sleeve. The instrument, containing
`which the hollow core 5, is made from a high friction
`the retracted stent, then may be re-positioned as re-
`material, for example, a polyurethane, and the grip
`quired and the deployment operation repeated with the
`member 9B comprises a length of said core having a
`stent in its correct position.
`larger diameter than the remainder of the core, indi-
`Deployment of the stent by withdrawing the outer
`cated schematically by the step 14. If said high friction
`sleeve relative to the core has the advantage that it
`material is a material that will take a set the grip mem-
`avoids the problem ofthe distal end of the stent digging
`ber may be simply a portion of the core without the
`into or snagging against the wall of the body canal,
`enlargement of diameter (not shown).
`which problem might occur if the stent were to be
`FIG.6 is a side elevation,partly in section, of part of
`pushed into the body canal from behind.
`an embodiment showing additional features. In this
`The capability of being able to retract the stent so that
`embodiment the outer sleeve 1, preferably made from
`the instrument may be repositioned without damage to
`polytetrafluoroethylene, has a smooth metal rim 15 at
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`5,026,377
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`8
`10. The combination according to claim 1, in which
`said grip memberis a sleeve of material having an outer
`surface which is substantially smooth and unbroken.
`11. The combination according to claim 1, in which
`said grip memberis a sleeve of material having an outer
`surface which is roughenedorirregular.
`12. The combination according to claim 1, in which
`said core is made from a high friction material and said
`grip member comprises a length of said core having a
`larger outer diameter than the remainder of the core.
`13. The combination according to claim 12, in which
`said high friction material is a polyurethane.
`14. The combination according to claim 1, in which
`said grip memberis at least as long as said stent.
`15. The combination according to claim 1, which
`includes one or more marker elements, each located at
`a predetermined position on the outer sleeve or core.
`16. The combination according to claim 15, in which
`each of said marker elementsis a band of metal or radi-
`opaque material attached to the periphery of the outer
`sleeve.
`17. The combination according of claim 1, in which
`said outer sleeve is a hollow catheter made from a low
`friction material.
`18. The combination according to claim 17, in which
`said low friction material is polytetrafluoroethylene.
`~
`19. The combination according to claim 17, in which
`the inner surface of the catheter has a layer of hardened
`material to prevent damage by the endsofthe stent.
`20. The combination accordingto claim 17, in which
`the soft distal end of the catheter has a protective hard
`hollow rim attached thereto.
`21. The combination according to claim 20, in which
`said rim is made of metal.
`22. The combination according to claim 1, in which
`said grip memberis provided with circumferential gaps
`adjacent its distal end and proximal end to accommo-
`date the endsofthe stent.
`23. The combination according to claim 1, in which a
`flexible filiform is attachedto the distal end of the core.
`24. A methodfor the deploymentofa self-expanding
`braided stent in a body canal, wherein said stent is pre-
`located on a grip member of a core within an outer
`sleeve of a instrument according to claim 1 so that the
`inner surface of the stent is releasably held by the outer
`contact surface of said grip member, which method
`comprises passing said instrument into the body canal
`until it reaches a position for proper placement of the
`stent and deploying thestent at said position by moving
`the outer sleeve proximally relative to the core, and
`withdrawing said instrument whenthe stent is properly
`located at the desired position in the body canal.
`*
`*
`* x
`
`7
`the stent or injury to the body canal is a distinct advan-
`tage of the present invention.
`Weclaim:
`1. In combination, a self-expanding braided stent and
`an instrument for the deployment or retraction of said
`stent in a body canal, which comprises an elongated
`tubular outer sleeve having a proximal end anda distal
`end, an elongated core disposed within said sleeve and
`movable relative to said sleeve, said core being longer
`than said sleeve and having a proximal end anda distal
`end and including a grip memberat or nearsaid distal
`end of the core, said grip member being an integral
`portion of the core or a sleeve or coating attached
`around the periphery of the core and being adapted to:
`(i) releasably hold said self-expanding stent within said
`outer sleeve, there being sufficient clearance between
`said grip memberandsaid outer sleeve to accommodate
`said stent without distortion, (ii) deploy said stent be-
`yond the distal lend ofsaid outer sleeve whensaid outer
`sleeve is moved in a backward direction relative to said
`core and(iii) retract said stent back within said outer
`sleeve when said coreis pulled in a backward direction
`relative to said outer sleeve.
`2. The combination according to claim 1, in which
`said core is hollow.
`3. The combination according to claim 2, which in-
`cludes an elongated flexible, steerable guide wire lo-
`cated within and along the axis ofsaid core.
`4. The combination according to claim 1, in which
`said core has a handle attached to its proximal end to
`facilitate movement at the core relative to the outer
`sleeve.
`5. The combination according to claim 1, in which
`the proximal end of said outer sleeve terminates in a-
`flange or handle to facilitate movement of the outer
`sleeve relative to said core.
`6. The combination according to claim 1, in which
`said grip memberis a sleeve of material with a friction
`contact surface.
`7. The combination according to claim 1, in which
`said grip member is made from a material that will take
`a set and is either an integral portion of said core or a
`sleeve attached around the periphery of the core.
`8. The combination according to claim 7, in which
`said material is a silicone rubber or a polyurethane.
`9. The combination according to claim 1, in which
`said grip member comprises a coating of a releasable
`adhesive.
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1014 - Page 7
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1014 - Page 7
`
`