Page 1 of 16
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`EDWARDS LIFESCIENCES EX. 1214
`Edwards Lifesciences v. Boston Scientific Scimed
`U.S. Patent No. 6,915,560
`
`

`

`U.S. Patent
`
`Apr.2, 2002
`
`Sheet 1 of 8
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`US 6,364,870 B1
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`Page 2 of 16
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`Page 2 of 16
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`U.S. Patent
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`Apr.2, 2002
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`Sheet 2 of 8
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`US 6,364,870 B1
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`Page 3 of 16
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`Page 3 of 16
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`U.S. Patent
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`Apr.2, 2002
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`Sheet 3 of 8
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`US 6,364,870 B1
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`FIG.10
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`Page 5 of 16
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`U.S. Patent
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`Apr.2, 2002
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`Sheet 5 of 8
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`4,870 B1
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`Page 8 of 16
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`U.S. Patent
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`Apr.2, 2002
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`Sheet 8 of 8
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`US 6,364,870 B1
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`Page 9 of 16
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`Page 9 of 16
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`1
`APPARATUS AND METHOD FOR SECURING
`A STENT ON A BALLOON
`
`US 6,364,870 B1
`
`2
`is a further object of this invention to provide an
`It
`apparatus for securing a stent on a balloon catheter, com-
`prising:
`a) a first clamping portion provided with a first clamping
`portion recess, said first clamping portion recess sized
`and adapted to receive a stent crimping sleeve;
`b) a second clamping portion provided with a second
`clamping portion recess, said second clamping portion
`The present invention relates generally to intravascular
`recess sized and adapted to receive a stent crimping
`stents for implanting into a living body. In particular, the
`sleeve, said first clamping portion recess and said
`present
`invention relates to intravascular stents that are
`second clamping portion recess defining a longitudinal
`expandedby aninflatable balloon catheter and to a method
`stent crimping sleeve channel having a variable cross-
`and apparatus for mounting and securing a stent on a balloon
`sectional diameter, said first and said second clamping
`catheter.
`portions adapted for movementinafirst direction away
`15
`from each other to a first position and in a second
`BACKGROUND OF THE INVENTION
`direction toward each other to a second position to
`selectively impart pressure to a stent crimping sleeve
`disposed in said longitudinal stent crimping sleeve
`channel, said clamping portion recesses sized and
`adapted so that said longitudinal stent crimping sleeve
`channel has a substantially circular cross-sectional
`diameter when said first and said second clamping
`portions are in said second position;
`c) a stent crimping sleeve disposed in said crimping
`sleeve channel, said sleeve having a first end, a second
`end, an outer surface, and an inner surface defining a
`longitudinal stent crimping bore therethrough, said
`longitudinal stent crimping bore having a selectively
`variable-substantially circular cross-sectional diameter
`and sized and adapted to receive a balloon catheter with
`a stent mounted thereon, said stent crimping sleeve
`further adapted to selectively and substantially uni-
`formly vary said substantially circular cross-sectional
`diameter of said longitudinal stent crimping bore in
`response to pressure applied to said external surface of
`said stent crimping sleeve by said first clamping portion
`and said second clamping portion when said first
`clamping portion and said second clamping portion are
`moved in said second direction.
`
`This Application is a continuation of prior application
`Ser. No. 09/218,503 filed Dec. 22, 1998 (now abandoned).
`
`FIELD OF THE INVENTION
`
`Intravascular stents having a constricted diameter for
`delivery through a blood vessel and an expanded diameter
`for applying a radially outwardly extending force for sup-
`porting the blood vessel are knownin the art. Selfexpand-
`able articulated stents are described, for example, in US.
`Pat. No. 5,104,404, entitled “Articulated Stent” to Wolff.
`Balloon expandable articulated stents are commercially
`available under the trade name Palmaz-Schatz Balloon-
`Expandable stents from Johnson & Johnson International
`Systems Co.
`In conventional stent mounting and securing procedures,
`the stent is usually first slid over the distal end of a balloon
`catheter so that the expandable balloon is disposed within
`the longitudinal bore of the stent. The stent is then crimped
`or pinched to mount or secure the stent and maintain its
`position with respect
`to the expandable balloon as the
`balloon catheter is advancedto the target area. This crimping
`is often done utilizing the fingers or a plier-like device to
`pinch the stent. One shortcoming of this conventional
`mounting and securing means is that
`it often produces
`irregular distortion of the stent which could cause trauma to
`the lumen beingtreated. Another shortcomingis that it may
`weaken a portion or portions of the stent which could result
`in stent failure. Yet another shortcoming of conventional
`mounting and securing methodsis that they maydistort the
`stent in such a way as to cause the stent to expand in the
`target area in a non-uniform manner which could result in a
`portion of the lumen not being properly supported.
`Yet another shortcoming of conventional mounting and
`securing methodsis irregular distortion of the stent could
`produce protrusionsin the stent which could cause trauma to
`the patient.
`Therefore, it would be highly desirable to have a method
`and an apparatus that permits a stent to be secured over the
`expandable balloon of a balloon catheter without causing
`irregular distortion or weakening thestent.
`
`OBJECTS AND SUMMARYOF THE
`INVENTION
`
`It is an object of this invention to provide an apparatus for
`securing a stent on a balloon catheter by substantially
`uniformly distorting the stent.
`It is another object of this invention to provide an appa-
`ratus for securing a stent on a balloon catheter that reduces
`the likelihood that the stent will expand in a nonuniform
`manner.
`
`It is yet another object of this invention to provide a
`methodof securing a stent on a balloon catheter that reduces
`the likelihood that the stent will be weakenedby the securing
`procedure.
`
`10
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`It is still another object of this invention to provide a
`method of securing an expandable stent having a longitu-
`dinal bore on a balloon catheter, comprising the steps of:
`a) constructing an apparatus comprising: a first clamping
`portion provided with a first clamping portion recess,
`said first clamping portion recess sized and adapted to
`receive a stent crimping sleeve; a second clamping
`portion provided with a second clamping portion
`recess, said second clamping portion recess sized and
`adapted to receive a stent crimping sleeve, said first
`clamping portion recess and said second clamping
`portion recess defining a longitudinal stent crimping
`sleeve channel having a variable cross-sectional
`diameter, said first and said second clamping portions
`adapted for movementin a first direction away from
`each other to a first position and in a second direction
`toward each other to a second position to selectively
`impart pressure to a stent crimping sleeve disposed in
`said longitudinal stent crimping sleeve channel, said
`clamping portion recesses sized and adapted so that
`said longitudinal stent crimping sleeve channel has a
`substantially circular cross-sectional diameter when
`said first and said second clamping portionsare in said
`second position; a stent crimping sleeve having a first
`end, a second end, an outer surface, and an inner
`surface defining a longitudinal stent crimping bore
`therethrough havinga selectively variable substantially
`circular cross-sectional diameter and sized and adapted
`
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`Page 10 of 16
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`Page 10 of 16
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`US 6,364,870 B1
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`3
`to receive a balloon catheter with a stent mounted
`thereon, said stent crimping sleeve further adapted to
`selectively and substantially uniformly vary said sub-
`stantially circular cross-sectional diameter of said lon-
`gitudinal stent crimping bore in response to pressure
`applied to said external surface of said stent crimping
`sleeve by said first clamping portion and said second
`clamping portion;
`b) disposing said stent crimping sleeve in said stent
`crimping sleeve channel;
`c) disposing said stent in said longitudinal stent crimping
`bore of said stent crimping sleeve;
`d) disposing said balloon catheter in said longitudinal
`bore of said stent; and
`e) moving said first and said second stent clamping
`portions from saidfirst position to said second position
`so as to apply pressure to said external surface of said
`stent crimping sleeve in an amount sufficient
`to
`decrease the substantially circular cross-sectional
`diameter of said longitudinal stent crimping bore in an
`amount sufficient for said inner surface of said stent
`
`crimping sleeve to impart sufficient pressure to said
`stent to secure said stent to said balloon catheter.
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`second clamping portion recess, said first and said
`second clamping portion recesses defining a longitudi-
`nal stent crimping element channel with a variable
`diameter, said first and said second clamping portions
`adapted for movementin a first direction away from
`each other to a first position and in a second direction
`toward each other to a second position;
`b) a first crimping element disposed within said longitu-
`dinal stent crimping element channelsaid first crimping
`element provided with a first crimping element contact
`surface, a second crimping element contact surface, a
`first clamping portion contact surface, and a stent
`crimping sleeve contact surface;
`c) a second crimping element disposed within said lon-
`gitudinal stent crimping channel, said second crimping
`element provided with a first crimping element contact
`surface, a second crimping element contact surface, a
`first clamping portion contact surface, and a stent
`crimping sleeve contact surface;
`d) a third crimping element disposed within said longi-
`tudinal stent crimping channel, said third crimping
`element provided with a first crimping element contact
`surface, a second crimping element contact surface, a
`second clamping portion contact surface, and a stent
`crimping sleeve contact surface;
`is a further object of this invention to provide an
`It
`a fourth crimping element disposed within said longi-
`apparatus for securing a stent on a balloon catheter, com-
`tudinal stent crimping channel, said fourth crimping
`prising:
`element provided with a first crimping element contact
`a) a first clamping portion havingafirst clamping portion
`surface, a second crimping element contact surface, a
`recess and a second clamping portion having a second
`second clamping portion contact surface, and a stent
`clamping portion recess, said first and said second
`crimping sleeve contact surface, said crimping ele-
`clamping portion recesses defining a longitudinal stent
`ments adapted for movementinafirst direction away
`crimping element channel with a variable cross-
`from each other to a first position and in a second
`sectional diameter, said first and said second clamping
`direction towards each other to a second position, said
`portions adapted for movementinafirst direction away
`stent crimping sleeve contact surfaces defining a stent
`35
`from each other to a first position and in a second
`crimping sleeve channel having a variable cross-
`direction toward each other to a second position;
`sectional diameter that is substantially circular—when
`b) a plurality of crimping elements disposed within said
`said plurality of crimping elements are disposed in said
`longitudinal stent crimping element channel defining a
`second position; and
`stent crimping sleeve channel having a variable cross-
`f) a stent crimping sleeve disposed in said longitudinal
`sectional diameter, said plurality of crimping elements
`stent crimping sleeve channel, said sleeve havinga first
`adapted for movementin a first direction away from
`end, a second end, an outer wall, and an inner wall
`each otherto a first position and in a second direction
`defining a longitudinal bore therethrough having a
`toward each other to a second position; and
`selectively variable substantially circular crosssec-
`c) a stent crimping sleeve disposed in said longitudinal
`tional diameter, said clamping portions, said crimping
`stent crimping sleeve channel, having a first end, a
`elements, and said sleeve adapted and disposed so that
`second end, an outer wall, and an inner wall defining a
`when said first clamping portion and said second
`longitudinal bore therethrough having a selectively
`clamping portion are in the second position, said crimp-
`variable substantially circular cross-sectional diameter,
`ing sleeve contact surfaces define a stent crimping
`said clamping portions said crimping elements, and
`sleeve channel having a substantially circular cross-
`said sleeve adapted and disposed so that whensaidfirst
`sectional diameter and said longitudinal bore defines a
`clamping portion, said second clamping portion, and
`longitudinal bore having a substantially circular cross-
`sectional diameter.
`said plurality of crimping elements are disposed in the
`second position, said crimping elements define a lon-
`gitudinal stent crimping sleeve channel having a sub-
`stantially circular crosssectional diameter and said lon-
`gitudinal stent crimping bore defines a longitudinal
`bore having a substantially circular cross-sectional
`diameter.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a side view ofa stent placed on a balloon catheter
`before the stent has been secured to the balloon;
`FIG. 2 is a side view of the stent of FIG. 1 after the stent
`has been securedto the balloon utilizing conventional secur-
`ing methods;
`FIG. 3 is a cross-sectional end view of a stent securing
`apparatus constructed in accordance with this invention with
`the clamping portions disposed in a first or non-securing
`position;
`FIG. 4 is a cross-sectional end view of a stent securing
`apparatus constructed in accordance with this invention with
`the clamping portions disposed in a second or securing
`position;
`
`It is a yet another object of this invention to provide an
`apparatus for securing a stent on a balloon catheter, com-
`prising:
`a) a first clamping portion and a second clamping portion,
`said first clamping portion provided with a first surface,
`a second surface and a third surface defining a first
`clamping portion recess, said second clamping portion
`provided with a first surface, a second surface, a third
`surface, a fourth surface and a fifth surface defining a
`
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`Page 11 of 16
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`Page 11 of 16
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`US 6,364,870 B1
`
`6
`5
`portion 6 and the second clamping portion 8 disposed in a
`FIG. 5 is a cross-sectional side view of a stent crimping
`sleeve constructed in accordance with the invention;
`first or non-securing position which providesafirst clear-
`ance D1 betweenthe first clamping portion 6 and the second
`FIG. 6 is an end view of the stent crimping sleeve shown
`clamping portion 8 that is adequate for inserting an uncom-
`in FIG. 5;
`pressed stent crimping sleeve into the stent crimping sleeve
`FIG. 7 is a cross-sectional side view of the stent crimping
`channel 10. FIG. 4 showsthe first clamping portion 6 and the
`sleeve of FIGS. 5 and 6 with the balloon catheter and stent
`second clamping portion 8 of FIG. 3 moved to a second or
`securing position with a second clearance D2 between the
`first clamping portion 6 and the second clamping portion 8
`that is less than that D1. Thus, when disposed in the second
`or securing position, the first clamping portion 6 and the
`second clamping portion 8 are closer to each other than they
`are when disposed in the first position and, as shown in
`FIGS. 3 and 4, the crimping sleeve channel 10 has a smaller
`diameter. As also shown in FIG. 4, whenthefirst clamping
`portion 6 and the second clamping portion 8 are in the
`second position,
`the crimping sleeve channel 10 has a
`substantially circular crosssectional diameter. The first
`clamping portion 6 and the second clamping portion 8 may
`be arranged in a variety of ways well knownto thoseskilled
`in the art which permits selective movement of the first
`clamping portion 6 and second clamping portion 8 from the
`first position to the second position, 1e., toward and away
`from each other. In the embodiment shown, a channel 11
`aligns the first clamping portion 6 and second clamping
`portion 8 and external pressure, e.g., finger pressure may be
`utilized to movethe first clamping portion 6 and 8 from the
`first position to the second position. In another embodiment,
`pneumatic pressure or an electrical motoris utilized to move
`the clamping portions 6 and 8. In an especially preferred
`embodiment, a pressure gauge and pressure regulator are
`utilized to control the amount of pressure applied. In still
`another embodiment,the first and second clamping portions
`6 and 8 are mounted on a plier like hinged device.
`FIG. 5 is a cross-sectional side view of a stent crimping
`sleeve 12 having an outer surface 13 and an inner surface 14
`defining a longitudinal stent crimping bore 15. FIG. 6 is an
`end view of FIG. 5. The stent crimping bore 15 has a
`selectively variable substantially circular crosssectional
`diameter that changes in response to external pressure
`applied to the external surface 13 of the stent crimping
`sleeve 12. The material comprising the stent crimping sleeve
`12 is selected from a material which will substantially
`uniformly vary and maintain the substantially circular cross-
`sectional diameter of the longitudinal stent crimping bore 15
`in response to pressure applied to the outer surface 13 of the
`stent crimping sleeve 12. In a preferred embodiment, poly-
`urethane is utilized.
`
`of FIG. 1 disposed within it prior to the stent being secured
`to the balloon;
`FIG. 8 is an end view of FIG. 7;
`FIG. 9 showsthe stent crimping sleeve shown in FIGS. 5
`and 6 disposed between the first and second clamping
`portions with the first and second clamping portions dis-
`posed in a first or non-securing position;
`FIG. 10 showsthe stent crimping sleeve shown on FIGS.
`5 and 6 disposed between the first and second clamping
`portions with the first and second clamping portions moved
`to a second or securing position;
`FIG. 11 shows the stent of FIG. 1 secured to the balloon
`
`catheter after being secured in accordance with the inven-
`tion;
`FIG. 12 showsanalternative embodimentof the invention
`having a first clamping portion and a second clamping
`portion disposed in a first position;
`FIG. 13 showsthe clamping portions shown in FIG. 12
`with a plurality of crimping elements disposed between the
`clamping portions;
`FIG. 14 showsthe clamping portions and crimping ele-
`ments of FIG. 13 disposed in a second position;
`FIG. 15 shows FIG. 13 with a stent crimping sleeve
`disposed between the crimping elements with the clamping
`portions and the crimping elements disposed in a first or
`non-securing position;
`FIG. 16 shows the embodiment shownin FIG. 15 with the
`clamping portions and the crimping elements disposed in a
`second or securing position;
`FIG. 17 is a cross-sectional side view of an alternative
`embodiment of the invention which utilizes a catheter pro-
`tector and a catheter protector and stent positioners;
`FIG. 18Ais an end view of the second catheter protector
`and stent positioner shown in FIG. 17;
`FIG. 18B is an end view of the first catheter protector
`shown in FIG. 17; and
`FIG. 19 is an enlarged detailed view of a portion of FIG.
`17.
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`DETAILED DESCRIPTION OF THE
`INVENTION
`
`FIG. 1 showsa conventional balloon catheter 1 and shows
`a catheter 2, a balloon 3, and a stent 4 mounted on the
`balloon 3 priorto the stent 4 being secured on the balloon 3.
`FIG. 2 showsthe stent of FIG. 1 after it has been secured to
`
`the balloon by conventional methods, e.g., by pinching
`between the fingers or by crimping with a conventional
`plier-like device. As shown in FIG. 2, the ends of the stent
`protrude and there is some irregular distortion of the stent
`between the two endsof the stent.
`
`FIG. 3 showsa stent securing apparatus 5 constructed in
`accordancewith the invention. FIG. 3 showsa first clamping
`portion 6 having a first clamping portion recess 7 and a
`second clamping portion 8 having a second clamping por-
`tion recess 9. The first clamping portion recess 7 and the
`second clamping portion recess 9 define a longitudinal stent
`crimping sleeve channel 10 with a selectively variable
`cross-sectional diameter. FIG. 3 showsthe first clamping
`
`50
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`60
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`FIG. 7 showsthestent 4, balloon 3, and catheter 2 of FIG.
`1 disposed within the longitudinal stent crimping bore 15 of
`the stent crimping sleeve 12 shown in FIG. 5 prior to the
`stent 4 being crimped and secured to the balloon 3. FIG. 8
`is an end view of FIG. 7.
`
`FIG. 9 showsthe stent crimping sleeve 12 of FIGS. 5 and
`6 disposed in the stent crimping sleeve channel 10 between
`the first stent clamping portion 6 and second stent clamping
`portion 8 of the stent securing apparatus 5. As shownin FIG.
`9,
`the first stent clamping portion 6 and second stent
`clamping portion 8 are disposed in a first position which
`provides adequate clearance in the stent crimping sleeve
`channel 10 for the stent crimping sleeve 12 to be easily
`inserted or removed from the stent crimping sleeve channel
`10. Longitudinal bore 15 has a substantially circular cross-
`sectional diameter D1.
`
`FIG. 10 differs from FIG. 9 in that the first stent clamping
`portion 6 and the second stent clamping portion 8 have been
`moved to a second position. The first clamping portion
`
`Page 12 of 16
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`Page 12 of 16
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`

`

`US 6,364,870 B1
`
`7
`recess 7 and the second clamping portion recess are sized
`and cooperatively adapted so that when disposed in the
`second position the first and second clamping portions 6 and
`8 define a channel 10 having a substantially circular cross-
`sectional diameter. As shown in FIG. 10, in response to the
`pressure applied bythe first and second clampingportions 6
`and 8 on the external wall 13 of the stent crimping sleeve 12,
`the stent crimping sleeve 12 is compressed. This causes the
`diameter of the longitudinal stent crimping bore 15 to be
`reduced substantially uniformly to a substantially circular
`crosssectional diameter D2 which is less than the uncom-
`
`10
`
`8
`and 32 disposed in a first or non-securing position, which
`provides a cross-sectional diameter No. of the stent crimping
`sleeve channel 101 that is adequate for inserting an uncom-
`pressed stent crimping sleeve 12 into the stent crimping
`sleeve channel 101. As the first clamping portion 16 and the
`second clamping portion 18 are moved to the second
`position, surface 19 impinge on surface 34, surface 21
`impinges upon surface 38, surface 23 impinges upon surface
`46 and surface 25 impinges upon surface 42 moving the
`crimping elements 29, 30, 31, and 32 to a second or securing
`position. FIG. 14 showsthe first clamping portion 16, the
`second clamping portion 18, and the crimping elements 29,
`30, 31, and 32 disposed in a second position the stent
`crimping sleeve surfaces 36, 40, 44, and 48 define a crimp-
`ing sleeve channel 10' having a substantially circular cross-
`sectional diameter D2 that is smaller than diameter No.
`
`pressed diameter D1 shown in FIG. 9. In response to the
`external pressure-applied to the outer surface 13, the inner
`surface 14 of the stent crimping bore 15 applies a substan-
`tially uniform pressure to the stent 4 in an amountsufficient
`so as to substantially uniformly crimp the stent 4 and secure
`it on the balloon 3 with minimalirregular distortion of the
`shown in FIG. 13. The first clamping portion 16 and second
`stent 4 because the longitudinal bore 15 maintains its
`clamping portion 18 may be arranged in a variety of ways
`substantially circular cross-sectional diameter when the
`well skilled to those skilled in the art which permits selective
`20
`stent crimping sleeve 12 is compressed and the diameter of
`movement of the first clamping portion 16 and second
`the stent crimping bore 15 is reduced.
`clamping portion 18 inafirst direction away from each other
`FIG. 11 is a side view of the stent shown in FIG. 1 after
`to a first position and in a second direction toward each other
`it has been secured in accordance with the invention and
`to a second position.
`FIGS. 15 and 16 show a stent crimping sleeve 12
`(previously discussed) disposed in the longitudinal stent
`crimping sleeve channel 10'. (The stent and balloon catheter
`have been omitted for clarity.) As shown in FIG. 15, when
`the first clamping portion 16 and the second clamping
`portion 18, and the crimping elements 29, 30, 31, and 32 are
`disposed in the first position, some portions of crimping
`element contact surfaces 36, 40, 44, and 48 may not be in
`contact with someportion of the outer surface 13 ofthe stent
`crimping sleeve 12 because whenthefirst clamping portion
`16,
`the second clamping portion 18, and the crimping
`elements 29, 30, 31, and 32 are in the first position, surfaces
`36, 40, 44, and 48 do not define a stent crimping sleeve
`channel 10, having a substantially circular crosssectional
`diameter. Thus, whenthe first and second clamping portions
`and the crimping elements are in the first or non-securing
`position, gaps 68 may exist between the outer surface 13 of
`the stent crimping sleeve 12 and crimping element contact
`surfaces 36, 40, 44, and 48. As shown in FIG. 16, however,
`whenfirst clamping portion 16, second clamping portion 18,
`and crimping elements 29, 30, 31, and 32 are disposed in the
`second or securing position, substantially all of crimping
`element contact surfaces 36, 40, 44, and 48 are in contact
`with the external surface 13 of the crimping sleeve 12
`because surfaces 36, 40, 44, and 48 are sized and adapted to
`define a stent crimping sleeve channel 10' having a substan-
`tially circular cross-sectional diameter whenthe first clamp-
`ing portion 16, the second clamping portion 18, and crimp-
`ing elements 29, 30, 31, and 32 are disposed in the second
`position.
`As shown in FIG. 15, whenthefirst clamping portion 16,
`the second clamping portion 18, and crimping elements 29,
`30, 31, and 32 are disposed in the first or non-securing
`position,
`the stent crimping bore 15 has a substantially
`circular cross-sectional diameter of D1. As shown in FIG.
`16, whenthefirst clamping portion 16, the second clamping
`portion 18, and crimping elements 29, 30, 31, and 32 are
`disposed in the second or securing position, the stent crimp-
`ing bore 15 has a substantially circular cross-sectional
`diameter D2 that is smaller than D1. Because the stent
`
`removedfrom the stent securing apparatus 5 and showsthat
`the stent 4 has been substantially uniformly crimped and
`secured on the balloon 3 with minimal irregular distortion.
`FIGS. 12 to 16 show an alternative embodiment of the
`
`invention that utilizes a plurality of crimping elements
`disposed between the clamping portions to apply pressure to
`a stent crimping sleeve. FIG. 12 showsa first clamping
`portion 16 and a second clamping portion 18. First clamping
`portion 16 is provided with a first surface 19, a second
`surface 20, and a third surface 21 defining a first clamping
`portion recess 66. Second clamping portion 18 is provided
`with a first surface 22, a second surface 23, a third surface
`24, a fourth surface 25 and a fifth surface 26 defining a
`second clamping portion recess 67. The surfaces 19, 20, 21,
`comprising the first clamping portion recess 66 and the
`surfaces 22, 23, 24, 25, and 26 comprising the second
`clamping portion recess 67 define a longitudinal stent crimp-
`ing element channel 27 with a selectively variable cross-
`sectional diameter.
`
`As shown in FIG. 13, disposed within the longitudinal
`stent crimping element channel 27 is a first crimping ele-
`ment 29, a second crimping element 30, a third crimping
`element 31 and a fourth crimping element32. First crimping
`element 29 is provided with a first crimping element contact
`surface 33, a second crimping element contact surface 35, a
`first clamping portion contact surface 34 and a stent crimp-
`ing sleeve contact surface 36. Second crimping element 30
`comprises a first crimping element contact surface 37, a
`second crimping element contact surface 39, a first clamping
`portion contact surface 38 and a stent crimping sleeve
`contact surface 40. Third crimping element 31 is provided
`with a first crimping element contact surface 41, a second
`crimping element contact surface 43, a second clamping
`portion contact surface 42 and a stent crimping sleeve
`contact surface 44. Fourth crimping element 32 is provided
`with a first crimping element contact surface 45, a second
`crimping element contact surface 47, a second clamping
`portion contact surface 46, and a stent crimping sleeve
`contact surface 48. The stent crimping sleeve contact sur-
`faces 36, 40, 44, and 48 define a stent crimping sleeve
`channel 10, having a selectively variable crosssectional
`diameter.
`
`FIG. 13 showsthe first clamping portion 16, the second
`clamping portion 18, and the crimping elements 29, 30, 31,
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`crimping bore 15 maintains its substantially circular cross-
`sectional diameter when first clamping portion 16, second
`clamping portion 18, and crimping elements 29, 30, 31, and
`32 are disposed in the second position, the inner surface 14
`
`Page 13 of 16
`
`Page 13 of 16
`
`

`

`US 6,364,870 B1
`
`10
`the stent
`into the longitudinal stent crimping bore until
`contacts the second catheter protector and stent positioner
`61. Because the second catheter protector and stent posi-
`tioner 61 has an inner ring aperture 64 that is smaller than
`the diameter of an uncrimped stent and greater than the
`diameter of the catheter, the catheter positioner and stent
`positioner 61 serves both to position the stent and to protect
`the distal end of the catheter. The catheter is then introduced
`into the longitudinal bore of the stent and the stent
`is
`crimped onto the balloon portion of catheter.
`After the stent has been crimped on the balloon portion of
`the catheter,
`the catheter with the stent crimped on it is
`withdrawn by pulling the catheter through the inner ring
`aperture 64! of the first catheter protector 60.
`Whatis claimedis:
`
`10
`
`15
`
`9
`of the stent crimping sleeve 12 applies substantially uniform
`pressure to the stent 4 to be crimped mounted on the balloon
`catheter 1 disposed within the longitudinal stent crimping
`bore 15 and substantially uniformly crimp and secure the
`stent 4 to the balloon catheter on which it is mounted with
`minimal irregular distortion of the stent 4.
`FIGS. 17 to 19 show analternative embodiment of the
`invention in whicha first catheter protector 60 and a second
`catheter protector and stent positioner 61 is utilized to
`protect the catheter shaft and also to limit the movementof
`the stent along the longitudinal axis of the catheter resulting
`in more precise placement on the catheter. FIG. 17 is a
`cross-sectional side view and shows a balloon catheter 1, a
`stent 4, a guide-wire 65, a first catheter protector 60 and a
`second catheter protector and stent positioner 61. FIG. 18A
`is an end view of the second catheter-protector and posi-
`tioner 61 shown in FIG. 17 and FIG. 18Bis an end view of
`the first catheter protector 60 shown in FIG. 17. As shown
`in FIG. 18A, the second catheter protector and stent posi-
`tioner 61 is circular in cross-section and comprises an outer
`ring 62 of compressible material and an inner ring 63 of
`substantially non-compressible material. The innerring 63 is
`provided with an inner ring aperture 64 having a substan-
`tially circular cross-sectional diameter. As shown in FIG.
`18B,thefirst catheter protector 60 is circular in cross-section
`and comprises an outer ring 62' of compressible material and
`an inner ring 63' of substantially non-compressible material.
`The innerring 63' is provided with an inner ring aperture 64'
`having a substantially circular cross-sectional diameter. In a
`preferred embodiment, the substantially compressible mate-
`rial is polyurethane and the substantially non-compressible
`material is metal.
`
`1. An apparatus for securing a stent having a longitudinal
`bore on a balloon catheter comprising:
`a) a first clamping portion and a second clamping portion,
`said first clamping portion provided with a first surface,
`a second surface and a third surface defining a first
`clamping portion recess, said second clamping portion
`provided with a first surface, a second surface, a third
`surface, a fourth surface and a fifth surface defining a
`second clamping portion recess, said first and said
`second clamping portion recesses defining a longitudi-
`nal stent crimping element channel with a variable
`diameter, said first and said second clamping portions
`adapted for movementin a first direction away from
`each other to a first position and in a second direction
`toward each other to a second position;
`b) a first crimping element disposed within said longitu-
`FIG. 19 is an enlarged view of the second catheter
`dinal stent crimping element channelsaid first