(12) United States Patent
`Pinchasik
`
`I lllll llllllll Ill lllll lllll lllll lllll lllll 111111111111111111111111111111111
`US006364870Bl
`US 6,364,870 Bl
`Apr. 2, 2002
`
`(10) Patent No.:
`(45) Date of Patent:
`
`(54) APPARATUS AND METHOD FOR SECURING
`A STENT ON A BALLOON
`
`(75)
`
`Inventor: Gregory Pinchasik, Herzlia (IL)
`
`(73) Assignee: Medino) Ltd., Tel Aviv (IL)
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) Appl. No.: 09/360,415
`
`(22) Filed:
`
`Jul. 23, 1999
`
`Related U.S. Application Data
`
`(63)
`
`(51)
`(52)
`(58)
`
`Continuation of application No. 09/218,503, filed on Dec.
`22, 1998, now abandoned.
`Int. CI.7 ................................................ A61B 17/00
`U.S. Cl. .............................................. 606/1; 29/516
`Field of Search ............................ 606/1, 108, 198;
`72/409.19, 402, 410, 466.8, 416; 425/517;
`29/516, 235, 270, 407.01, 282, 283.5; 623/1.11,
`1.12, 1.23
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5,183,085 A
`5,353,623 A
`5,546,646 A
`5,630,830 A
`
`2/1993 Timmermans
`* 10/1994 Bobenhausen ... ... ... ... .. . 72/402
`8/1996 Williams et al.
`5/1997 Verbeek
`
`5,725,519 A
`5,893,867 A *
`5,893,868 A
`5,931,851 A
`5,951,540 A *
`5,992,000 A
`6,009,614 A *
`6,024,737 A
`
`3/1998
`4/1999
`4/1999
`8/1999
`9/1999
`11/1999
`1/2000
`2/2000
`
`Penner et al.
`Bagaoisan et al. .......... 606/198
`Hanson et al.
`Mroales
`Verbeek ... ... ... ... .. ... ... ... .. 606/1
`Humphrey et al.
`Morales ....................... 29/561
`Morales
`
`FOREIGN PATENT DOCUMENTS
`
`3/1999
`6/1997
`
`DE
`195 32 288
`W097/20593
`WO
`* cited by examiner
`Primary Examiner-Eduardo C. Robert
`(74) Attorney, Agent, or Firm-Kenyon & Kenyon
`
`(57)
`
`ABSTRACT
`
`Apparatus and method for securing a stent to a balloon
`catheter. A first clamping portion and a second clamping
`portion are arranged for movement toward and away from
`each other and are provided with recesses defining a channel
`to receive a stent crimping sleeve having a longitudinal bore.
`The stent is slid into the longitudinal bore of the stent
`crimping sleeve and the balloon catheter is then slid into the
`longitudinal bore of the stent. The first and second clamping
`portions are moved towards each other and apply pressure to
`the external surface of the stent crimping sleeve causing the
`internal diameter of the longitudinal bore to get smaller and
`apply pressure to the external surface of the stent and crimp
`the stent to the balloon.
`
`5 Claims, 8 Drawing Sheets
`
`6
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`11
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`7
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`Page 1 of 16
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`EDWARDS LIFESCIENCES EX. 1114
`Edwards Lifesciences v. Boston Scientific Scimed
`U.S. Patent No. 6,915,560
`
`

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`U.S. Patent
`
`Apr. 2, 2002
`
`Sheet 1of8
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`U.S. Patent
`U.S. Patent
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`Apr. 2, 2002
`Apr. 2, 2002
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`Apr. 2, 2002
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`Page 4 of 16
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`U.S. Patent
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`Apr. 2, 2002
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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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`

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`US 6,364,870 Bl
`
`1
`APPARATUS AND METHOD FOR SECURING
`A STENT ON A BALLOON
`
`This Application is a continuation of prior application
`Ser. No. 09/218,503 filed Dec. 22, 1998 (now abandoned). 5
`
`FIELD OF THE INVENTION
`
`The present invention relates generally to intravascular
`stents for implanting into a living body. In particular, the
`present invention relates to intravascular stents that are
`expanded by an inflatable balloon catheter and to a method
`and apparatus for mounting and securing a stent on a balloon
`catheter.
`
`BACKGROUND OF THE INVENTION
`
`10
`
`15
`
`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(cid:173)
`porting the blood vessel are known in the art. Selfexpand- 20
`able articulated stents are described, for example, in U.S.
`Pat. No. 5,104,404, entitled "Articulated Stent" to Wolff.
`Balloon expandable articulated stents are commercially
`available under the trade name Palmaz-Schatz Balloon(cid:173)
`Expandable stents from Johnson & Johnson International 25
`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 30
`or pinched to mount or secure the stent and maintain its
`position with respect to the expandable balloon as the
`balloon catheter is advanced to 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 35
`mounting and securing means is that it often produces
`irregular distortion of the stent which could cause trauma to
`the lumen being treated. Another shortcoming is that it may
`weaken a portion or portions of the stent which could result
`in stent failure. Yet another shortcoming of conventional 40
`mounting and securing methods is that they may distort 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 45
`securing methods is irregular distortion of the stent could
`produce protrusions in 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 50
`expandable balloon of a balloon catheter without causing
`irregular distortion or weakening the stent.
`
`OBJECTS AND SUMMARY OF THE
`INVENTION
`
`55
`
`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- 60
`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
`method of securing a stent on a balloon catheter that reduces 65
`the likelihood that the stent will be weakened by the securing
`procedure.
`
`2
`It is a further object of this invention to provide an
`apparatus for securing a stent on a balloon catheter, com(cid:173)
`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
`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(cid:173)
`sectional diameter, said first and said second clamping
`portions adapted for movement in 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
`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(cid:173)
`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.
`It is still another object of this invention to provide a
`method of securing an expandable stent having a longitu(cid:173)
`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 movement in 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 portions are 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 having a selectively variable substantially
`circular cross-sectional diameter and sized and adapted
`
`Page 10 of 16
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`US 6,364,870 Bl
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`10
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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(cid:173)
`stantially circular cross-sectional diameter of said lon(cid:173)
`gitudinal stent crimping bore in response to pressure 5
`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 said first 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.
`It is a further object of this invention to provide an 25
`apparatus for securing a stent on a balloon catheter, com(cid:173)
`prising:
`a) a first clamping portion having a first clamping portion
`recess and a second clamping portion having a second
`clamping portion recess, said first and said second 30
`clamping portion recesses defining a longitudinal stent
`crimping element channel with a variable cross(cid:173)
`sectional diameter, said first and said second clamping
`portions adapted for movement in a first direction away
`from each other to a first position and in a second 35
`direction toward each other to a second position;
`b) a plurality of crimping elements disposed within said
`longitudinal stent crimping element channel defining a
`stent crimping sleeve channel having a variable cross(cid:173)
`sectional diameter, said plurality of crimping elements 40
`adapted for movement in a first direction away from
`each other to a first position and in a second direction
`toward each other to a second position; and
`c) a stent crimping sleeve disposed in said longitudinal
`stent crimping sleeve channel, having a first end, a 45
`second end, an outer wall, and an inner wall defining a
`longitudinal bore therethrough having a selectively
`variable substantially circular cross-sectional diameter,
`said clamping portions said crimping elements, and
`said sleeve adapted and disposed so that when said first 50
`clamping portion, said second clamping portion, and
`said plurality of crimping elements are disposed in the
`second position, said crimping elements define a lon(cid:173)
`gitudinal stent crimping sleeve channel having a sub(cid:173)
`stantially circular crosssectional diameter and said lon- 55
`gitudinal stent crimping bore defines a longitudinal
`bore having a substantially circular cross-sectional
`diameter.
`It is a yet another object of this invention to provide an
`apparatus for securing a stent on a balloon catheter, com- 60
`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 65
`provided with a first surface, a second surface, a third
`surface, a fourth surface and a fifth surface defining a
`
`4
`second clamping portion recess, said first and said
`second clamping portion recesses defining a longitudi(cid:173)
`nal stent crimping element channel with a variable
`diameter, said first and said second clamping portions
`adapted for movement in 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(cid:173)
`dinal stent crimping element channel said 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(cid:173)
`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(cid:173)
`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;
`e) a fourth crimping element disposed within said longi(cid:173)
`tudinal stent crimping channel, said fourth 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, said crimping ele(cid:173)
`ments adapted for movement in a first direction away
`from each other to a first position and in a second
`direction towards each other to a second position, said
`stent crimping sleeve contact surfaces defining a stent
`crimping sleeve channel having a variable cross(cid:173)
`sectional diameter that is substantially circular-when
`said plurality of crimping elements are disposed in said
`second position; and
`f) a stent crimping sleeve disposed in said longitudinal
`stent crimping sleeve channel, said sleeve having a first
`end, a second end, an outer wall, and an inner wall
`defining a longitudinal bore therethrough having a
`selectively variable substantially circular crosssec(cid:173)
`tional diameter, said clamping portions, said crimping
`elements, and said sleeve adapted and disposed so that
`when said first clamping portion and said second
`clamping portion are in the second position, said crimp(cid:173)
`ing sleeve contact surfaces define a stent crimping
`sleeve channel having a substantially circular cross(cid:173)
`sectional diameter and said longitudinal bore defines a
`longitudinal bore having a substantially circular cross(cid:173)
`sectional diameter.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. l is a side view of a 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 secured to the balloon utilizing conventional secur(cid:173)
`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;
`
`Page 11 of 16
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`US 6,364,870 Bl
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`5
`FIG. 5 is a cross-sectional side view of a stent crimping
`sleeve constructed in accordance with the invention;
`FIG. 6 is an end view of the stent crimping sleeve shown
`in FIG. 5;
`FIG. 7 is a cross-sectional side view of the stent crimping 5
`sleeve of FIGS. 5 and 6 with the balloon catheter and stent
`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 shows the 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(cid:173)
`posed in a first or non-securing position;
`FIG. 10 shows the 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- 20
`tion;
`FIG. 12 shows an alternative embodiment of the invention
`having a first clamping portion and a second clamping
`portion disposed in a first position;
`FIG. 13 shows the clamping portions shown in FIG. 12
`with a plurality of crimping elements disposed between the
`clamping portions;
`FIG. 14 shows the clamping portions and crimping ele(cid:173)
`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 shown in FIG.15 with the 35
`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(cid:173)
`tector and a catheter protector and stent positioners;
`FIG. 18A is 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.
`
`10
`
`6
`portion 6 and the second clamping portion 8 disposed in a
`first or non-securing position which provides a first clear(cid:173)
`ance Dl between the first clamping portion 6 and the second
`clamping portion 8 that is adequate for inserting an uncom-
`pressed stent crimping sleeve into the stent crimping sleeve
`channel 10. FIG. 4 shows the first clamping portion 6 and the
`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 Dl. 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
`15 diameter. As also shown in FIG. 4, when the first 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 known to those skilled
`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, i.e., toward and away
`from each other. In the embodiment shown, a channel 11
`25 aligns the first clamping portion 6 and second clamping
`portion 8 and external pressure, e.g., finger pressure may be
`utilized to move the first clamping portion 6 and 8 from the
`first position to the second position. In another embodiment,
`pneumatic pressure or an electrical motor is utilized to move
`30 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
`40 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-
`45 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(cid:173)
`urethane is utilized.
`FIG. 7 shows the stent 4, balloon 3, and catheter 2 of FIG.
`50 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 shows the stent crimping sleeve 12 of FIGS. 5 and
`55 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 shown in FIG.
`9, the first stent clamping portion 6 and second stent
`clamping portion 8 are disposed in a first position which
`60 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(cid:173)
`sectional diameter Dl.
`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
`
`DETAILED DESCRIPTION OF IBE
`INVENTION
`
`FIG. 1 shows a conventional balloon catheter 1 and shows
`a catheter 2, a balloon 3, and a stent 4 mounted on the
`balloon 3 prior to the stent 4 being secured on the balloon 3.
`FIG. 2 shows the 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 ends of the stent.
`FIG. 3 shows a stent securing apparatus 5 constructed in
`accordance with the invention. FIG. 3 shows a first clamping
`portion 6 having a first clamping portion recess 7 and a
`second clamping portion 8 having a second clamping por(cid:173)
`tion recess 9. The first clamping portion recess 7 and the
`second clamping portion recess 9 define a longitudinal stent 65
`crimping sleeve channel 10 with a selectively variable
`cross-sectional diameter. FIG. 3 shows the first clamping
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`Page 12 of 16
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`US 6,364,870 Bl
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`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(cid:173)
`sectional diameter. As shown in FIG. 10, in response to the
`pressure applied by the first and second clamping portions 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(cid:173)
`pressed diameter Dl 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(cid:173)
`tially uniform pressure to the stent 4 in an amount sufficient
`so as to substantially uniformly crimp the stent 4 and secure
`it on the balloon 3 with minimal irregular distortion of the
`stent 4 because the longitudinal bore 15 maintains its
`substantially circular cross-sectional diameter when the
`stent crimping sleeve 12 is compressed and the diameter of
`the stent crimping bore 15 is reduced.
`FIG. 11 is a side view of the stent shown in FIG. 1 after
`it has been secured in accordance with the invention and
`removed from the stent securing apparatus 5 and shows that
`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 shows a 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(cid:173)
`ing element channel 27 with a selectively variable cross(cid:173)
`sectional diameter.
`As shown in FIG. 13, disposed within the longitudinal
`stent crimping element channel 27 is a first crimping ele(cid:173)
`ment 29, a second crimping element 30, a third crimping
`element 31 and a fourth crimping element 32. 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(cid:173)
`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 55
`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 60
`portion contact surface 46, and a stent crimping sleeve
`contact surface 48. The stent crimping sleeve contact sur(cid:173)
`faces 36, 40, 44, and 48 define a stent crimping sleeve
`channel 10, having a selectively variable crosssectional
`diameter.
`FIG. 13 shows the first clamping portion 16, the second
`clamping portion 18, and the crimping elements 29, 30, 31,
`
`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(cid:173)
`pressed stent crimping sleeve 12 into the stent crimping
`5 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
`10 crimping elements 29, 30, 31, and 32 to a second or securing
`position. FIG. 14 shows the 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-
`15 ing sleeve channel 10' having a substantially circular cross(cid:173)
`sectional diameter D2 that is smaller than diameter No.
`shown in FIG. 13. The first clamping portion 16 and second
`clamping portion 18 may be arranged in a variety of ways
`well skilled to those skilled in the art which permits selective
`20 movement of the first clamping portion 16 and second
`clamping portion 18 in a first direction away from each other
`to a first position and in a second direction toward each other
`to a second position.
`FIGS. 15 and 16 show a stent crimping sleeve 12
`25 (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
`30 disposed in the first position, some portions of crimping
`element contact surfaces 36, 40, 44, and 48 may not be in
`contact with some portion of the outer surface 13 of the stent
`crimping sleeve 12 because when the first clamping portion
`16, the second clamping portion 18, and the crimping
`35 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, when the first and second clamping portions
`and the crimping elements are in the first or non-securing
`40 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,
`when first clamping portion 16, second clamping portion 18,
`and crimping elements 29, 30, 31, and 32 are disposed in the
`45 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-
`50 tially circular cross-sectional diameter when the first clamp(cid:173)
`ing portion 16, the second clamping portion 18, and crimp(cid:173)
`ing elements 29, 30, 31, and 32 are disposed in the second
`position.
`As shown in FIG. 15, when the first 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 Dl. As shown in FIG.
`16, when the