(12)
`
`United States Patent
`Pinchasik
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 6,364,870 B1
`Apr. 2, 2002
`
`US006364870B1
`
`(54) APPARATUS AND METHOD FOR SECURING
`A STENT ()N A BALLOON
`
`(75) Inventor: Gregory Pinchasik, HerZlia (IL)
`
`-
`-
`_
`-
`(73) Asslgnee' Medmol Ltd" Tel AVW (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 US, Application Data
`
`3/1998 Penner et al.
`5,725,519 A
`5,893,867 A * 4/1999 Bagaoisan et al. ........ .. 606/198
`5,893,868 A
`4/1999 Hanson et al.
`59317851 A
`8/1999 Mroales
`5,951,540 A * 9/1999 Verbeek ....................... .. 606/1
`5,992,000 A 11/1999 Humphrey et al.
`6,009,614 A * 1/2000 Morales ..................... .. 29/561
`
`2/2000 Morales
`6’O24’737 A
`FOREIGN PATENT DOCUMENTS
`
`DE
`WO
`
`195 32 288
`WO97/20593
`
`3/1999
`6/1997
`
`* cited by examiner
`
`Primary Examiner—Eduardo C. Robert
`(74) Attorney, Agent, or Firm—Kenyon & Kenyon
`
`(63) Continuation of application No. 09/218,503, ?led on Dec.
`22’ 1998’ now abandoned‘
`(51) Int. Cl.7 .............................................. .. A61B 17/00
`
`ABSTRACT
`(57)
`Apparatus and method for securing a stent to a balloon
`Catheter- A ?rst clamping portion and a second clamping
`
`(52) US. Cl. . . . . . . . . . . . . . . . .
`. . . . . . . . .. 606/1; 29/516
`(58) Field of Search .......................... .. 606/1 108 198'
`72/409_19 402 410 4668 416’. 425/517?
`29/516 235 27,0 40,701,282 2,835.,623/111,
`’
`’
`’
`’
`’
`112 123’
`’
`
`(56)
`
`References Cited
`
`US. PATENT DOCUMENTS
`
`2/1993 Timmermans
`5,183,085 A
`5,353,623 A * 10/1994 Bobenhausen ............. .. 72/402
`5,546,646 A
`8/1996 Williams et al.
`5,630,830 A
`5/1997 Verbeek
`
`Portion are arranged for movement toward and away from
`each other and are Provided With recesses de?ning a Channel
`to receive a stent crimping sleeve having a longitudinal bore.
`The stent IS 511d IIliO the longitudinal bore Of the stent
`crimping sleeve and the balloon catheter is then slid into the
`longitudinal bore of the stent. The ?rst 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
`
`K11
`
`+5
`
`Page 1 of 16
`
`

`

`U.S. Patent
`
`Apr. 2, 2002
`
`Sheet 1 0f 8
`
`US 6,364,870 B1
`
`://\////% j’
`
`/
`
`12
`
`3*1
`
`FIG. 1
`
`:
`
`f ’ M
`
`FIG. 2
`
`2
`(L
`
`/ f f
`J
`
`94-4
`
`FIG. 11
`
`Page 2 of 16
`
`

`

`U.S. Patent
`
`Apr. 2, 2002
`
`Sheet 2 0f 8
`
`US 6,364,870 B1
`
`11
`
`11
`
`4
`
`FIG.
`
`3
`
`FIG.
`
`Page 3 of 16
`
`

`

`U.S. Patent
`
`Apr. 2, 2002
`
`Sheet 3 0f 8
`
`US 6,364,870 B1
`
`r12
`
`14
`/
`
`15
`_
`
`\
`13
`
`FIG. 5
`
`13
`
`\12
`FIG. 6
`
`1/3
`
`14-1,;
`
`C
`15-}?
`
`/12
`3
`if
`“\4
`
`2
`/
`
`5 <—1
`
`Page 4 of 16
`
`

`

`U.S. Patent
`
`A r.2 2002
`
`Sheet 4 of8
`
`FIG. 10
`
`FIG. 9
`
`Page 5 of 16
`
`

`

`U.S. Patent
`
`Apr. 2, 2002
`
`Sheet 5 0f 8
`
`US 6,364,870 B1
`
`911/
`
`NP
`
`1mm
`
`NNL
`
`mm
`
`mm
`
`a?
`
`Page 6 of 16
`
`

`

`
`
`m1
`
`7VM/7/
`ZY////
`
`//
`
` /
`
`//
`
`
`
`Page 7 of 16
`
`
`
`

`

`/
`
`
`
`Page 8 of 16
`
`
`

`

`U.S. Patent
`
`Apr. 2, 2002
`
`Sheet 8 0f 8
`
`US 6,364,870 B1
`
`7
`
`64'\\,, _ _ _ _ _ _ _____ 6 '_
`
`N5
`
`FIG. 17
`
`64
`
`62
`H61
`63
`
`FIG. 18A
`
`Page 9 of 16
`
`

`

`US 6,364,870 B1
`
`1
`APPARATUS AND METHOD FOR SECURING
`A STENT ON A BALLOON
`
`This Application is a continuation of prior application
`Ser. No. 09/218,503 ?led Dec. 22, 1998 (noW abandoned).
`
`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 in?atable balloon catheter and to a method
`and apparatus for mounting and securing a stent on a balloon
`catheter.
`
`BACKGROUND 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 knoWn in 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 ?rst 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 advanced to the target area. This crimping
`is often done utiliZing the ?ngers 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 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
`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
`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
`expandable balloon of a balloon catheter Without causing
`irregular distortion or Weakening the stent.
`
`OBJECTS AND SUMMARY OF 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
`method of securing a stent on a balloon catheter that reduces
`the likelihood that the stent Will be Weakened by the securing
`procedure.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`45
`
`55
`
`60
`
`65
`
`2
`It is a further object of this invention to provide an
`apparatus for securing a stent on a balloon catheter, com
`prising:
`a) a ?rst clamping portion provided With a ?rst clamping
`portion recess, said ?rst 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 ?rst clamping portion recess and said
`second clamping portion recess de?ning a longitudinal
`stent crimping sleeve channel having a variable cross
`sectional diameter, said ?rst and said second clamping
`portions adapted for movement in a ?rst direction aWay
`from each other to a ?rst 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 ?rst 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 ?rst end, a second
`end, an outer surface, and an inner surface de?ning 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 ?rst clamping portion
`and said second clamping portion When said ?rst
`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
`dinal bore on a balloon catheter, comprising the steps of:
`a) constructing an apparatus comprising: a ?rst clamping
`portion provided With a ?rst clamping portion recess,
`said ?rst 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 ?rst
`clamping portion recess and said second clamping
`portion recess de?ning a longitudinal stent crimping
`sleeve channel having a variable cross-sectional
`diameter, said ?rst and said second clamping portions
`adapted for movement in a ?rst direction aWay from
`each other to a ?rst 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 ?rst and said second clamping portions are in said
`second position; a stent crimping sleeve having a ?rst
`end, a second end, an outer surface, and an inner
`surface de?ning a longitudinal stent crimping bore
`therethrough having a selectively variable substantially
`circular cross-sectional diameter and siZed and adapted
`
`Page 10 of 16
`
`

`

`US 6,364,870 B1
`
`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 ?rst 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 ?rst and said second stent clamping
`portions from said ?rst position to said second position
`so as to apply pressure to said eXternal surface of said
`stent crimping sleeve in an amount suf?cient to
`decrease the substantially circular cross-sectional
`diameter of said longitudinal stent crimping bore in an
`amount suf?cient for said inner surface of said stent
`crimping sleeve to impart suf?cient pressure to said
`stent to secure said stent to said balloon catheter.
`It is a further object of this invention to provide an
`apparatus for securing a stent on a balloon catheter, com
`prising:
`a) a ?rst clamping portion having a ?rst clamping portion
`recess and a second clamping portion having a second
`clamping portion recess, said ?rst and said second
`clamping portion recesses de?ning a longitudinal stent
`crimping element channel With a variable cross
`sectional diameter, said ?rst and said second clamping
`portions adapted for movement in a ?rst direction aWay
`from each other to a ?rst position and in a second
`direction toWard each other to a second position;
`b) a plurality of crimping elements disposed Within said
`longitudinal stent crimping element channel de?ning a
`stent crimping sleeve channel having a variable cross
`sectional diameter, said plurality of crimping elements
`adapted for movement in a ?rst direction aWay from
`each other to a ?rst 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 ?rst end, a
`second end, an outer Wall, and an inner Wall de?ning 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 ?rst
`clamping portion, said second clamping portion, and
`said plurality of crimping elements are disposed in the
`second position, said crimping elements de?ne a lon
`gitudinal stent crimping sleeve channel having a sub
`stantially circular crosssectional diameter and said lon
`gitudinal stent crimping bore de?nes 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
`prising:
`a) a ?rst clamping portion and a second clamping portion,
`said ?rst clamping portion provided With a ?rst surface,
`a second surface and a third surface de?ning a ?rst
`clamping portion recess, said second clamping portion
`provided With a ?rst surface, a second surface, a third
`surface, a fourth surface and a ?fth surface de?ning a
`
`10
`
`15
`
`25
`
`35
`
`45
`
`55
`
`65
`
`4
`second clamping portion recess, said ?rst and said
`second clamping portion recesses de?ning a longitudi
`nal stent crimping element channel With a variable
`diameter, said ?rst and said second clamping portions
`adapted for movement in a ?rst direction aWay from
`each other to a ?rst position and in a second direction
`toWard each other to a second position;
`b) a ?rst crimping element disposed Within said longitu
`dinal stent crimping element channel said ?rst crimping
`element provided With a ?rst crimping element contact
`surface, a second crimping element contact surface, a
`?rst 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 ?rst crimping element contact
`surface, a second crimping element contact surface, a
`?rst 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 ?rst crimping element contact
`surface, a second crimping element contact surface, a
`second clamping portion contact surface, and a stent
`crimping sleeve contact surface;
`a fourth crimping element disposed Within said longi
`tudinal stent crimping channel, said fourth crimping
`element provided With a ?rst 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
`ments adapted for movement in a ?rst direction aWay
`from each other to a ?rst position and in a second
`direction toWards each other to a second position, said
`stent crimping sleeve contact surfaces de?ning a stent
`crimping sleeve channel having a variable cross
`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 ?rst
`end, a second end, an outer Wall, and an inner Wall
`de?ning a longitudinal bore therethrough having a
`selectively variable substantially circular crosssec
`tional diameter, said clamping portions, said crimping
`elements, and said sleeve adapted and disposed so that
`When said ?rst clamping portion and said second
`clamping portion are in the second position, said crimp
`ing sleeve contact surfaces de?ne a stent crimping
`sleeve channel having a substantially circular cross
`sectional diameter and said longitudinal bore de?nes a
`longitudinal bore having a substantially circular cross
`sectional diameter.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 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
`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 ?rst 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
`
`

`

`US 6,364,870 B1
`
`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
`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 ?rst and second clamping
`portions With the ?rst and second clamping portions dis
`posed in a ?rst or non-securing position;
`FIG. 10 shoWs the stent crimping sleeve shoWn on FIGS.
`5 and 6 disposed betWeen the ?rst and second clamping
`portions With the ?rst 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 shoWs an alternative embodiment of the invention
`having a ?rst clamping portion and a second clamping
`portion disposed in a ?rst 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
`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 ?rst or
`non-securing position;
`FIG. 16 shoWs the embodiment shoWn in 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. 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 ?rst catheter protector
`shoWn in FIG. 17; and
`FIG. 19 is an enlarged detailed vieW of a portion of FIG.
`17.
`
`DETAILED DESCRIPTION OF THE
`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 ?ngers 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 ?rst clamping
`portion 6 having a ?rst clamping portion recess 7 and a
`second clamping portion 8 having a second clamping por
`tion recess 9. The ?rst clamping portion recess 7 and the
`second clamping portion recess 9 de?ne a longitudinal stent
`crimping sleeve channel 10 With a selectively variable
`cross-sectional diameter. FIG. 3 shoWs the ?rst clamping
`
`15
`
`25
`
`35
`
`45
`
`55
`
`65
`
`6
`portion 6 and the second clamping portion 8 disposed in a
`?rst or non-securing position Which provides a ?rst clear
`ance D1 betWeen the ?rst 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 ?rst 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
`?rst 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 ?rst clamping portion 6 and the
`second clamping portion 8 are closer to each other than they
`are When disposed in the ?rst position and, as shoWn in
`FIGS. 3 and 4, the crimping sleeve channel 10 has a smaller
`diameter. As also shoWn in FIG. 4, When the ?rst 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 ?rst
`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 ?rst
`clamping portion 6 and second clamping portion 8 from the
`?rst position to the second position, i.e., toWard and aWay
`from each other. In the embodiment shoWn, a channel 11
`aligns the ?rst clamping portion 6 and second clamping
`portion 8 and external pressure, e.g., ?nger pressure may be
`utiliZed to move the ?rst clamping portion 6 and 8 from the
`?rst position to the second position. In another embodiment,
`pneumatic pressure or an electrical motor is 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 ?rst 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
`de?ning 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.
`FIG. 7 shoWs the stent 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 shoWs the stent crimping sleeve 12 of FIGS. 5 and
`6 disposed in the stent crimping sleeve channel 10 betWeen
`the ?rst stent clamping portion 6 and second stent clamping
`portion 8 of the stent securing apparatus 5. As shoWn in FIG.
`9, the ?rst stent clamping portion 6 and second stent
`clamping portion 8 are disposed in a ?rst 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 ?rst stent clamping
`portion 6 and the second stent clamping portion 8 have been
`moved to a second position. The ?rst clamping portion
`
`Page 12 of 16
`
`

`

`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 ?rst and second clamping portions 6 and
`8 de?ne a channel 10 having a substantially circular cross
`sectional diameter. As shoWn in FIG. 10, in response to the
`pressure applied by the ?rst 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
`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 amount suf?cient
`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 ?rst clamping
`portion 16 and a second clamping portion 18. First clamping
`portion 16 is provided With a ?rst surface 19, a second
`surface 20, and a third surface 21 de?ning a ?rst clamping
`portion recess 66. Second clamping portion 18 is provided
`With a ?rst surface 22, a second surface 23, a third surface
`24, a fourth surface 25 and a ?fth surface 26 de?ning a
`second clamping portion recess 67. The surfaces 19, 20, 21,
`comprising the ?rst clamping portion recess 66 and the
`surfaces 22, 23, 24, 25, and 26 comprising the second
`clamping portion recess 67 de?ne 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 ?rst crimping ele
`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 ?rst crimping element contact
`surface 33, a second crimping element contact surface 35, a
`?rst clamping portion contact surface 34 and a stent crimp
`ing sleeve contact surface 36. Second crimping element 30
`comprises a ?rst crimping element contact surface 37, a
`second crimping element contact surface 39, a ?rst clamping
`portion contact surface 38 and a stent crimping sleeve
`contact surface 40. Third crimping element 31 is provided
`With a ?rst 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 ?rst 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 de?ne a stent crimping sleeve
`channel 10, having a selectively variable crosssectional
`diameter.
`FIG. 13 shoWs the ?rst clamping portion 16, the second
`clamping portion 18, and the crimping elements 29, 30, 31,
`
`15
`
`25
`
`35
`
`45
`
`55
`
`65
`
`8
`and 32 disposed in a ?rst 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 ?rst 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 shoWs the ?rst 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 de?ne a crimp
`ing sleeve channel 10‘ having a substantially circular cross
`sectional diameter D2 that is smaller than diameter No.
`shoWn in FIG. 13. The ?rst 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
`movement of the ?rst clamping portion 16 and second
`clamping portion 18 in a ?rst direction aWay from each other
`to a ?rst position and in a second direction toWard each other
`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 ?rst clamping portion 16 and the second clamping
`portion 18, and the crimping elements 29, 30, 31, and 32 are
`disposed in the ?rst 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 ?rst clamping portion
`16, the second clamping portion 18, and the crimping
`elements 29, 30, 31, and 32 are in the ?rst position, surfaces
`36, 40, 44, and 48 do not de?ne a stent crimping sleeve
`channel 10, having a substantially circular crosssectional
`diameter. Thus, When the ?rst and second clamping portions
`and the crimping elements are in the ?rst 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,
`When ?rst 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
`de?ne a stent crimping sleeve channel 10‘ having a substan
`tially circular cross-sectional diameter When the ?rst 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, When the ?rst clamping portion 16,
`the second clamping portion 18, and crimping elements 29,
`30, 31, and 32 are disposed in the ?rst or non-securing
`position, the stent crimping bore 15 has a substantially
`circular cross-sectional diameter of D1. As shoWn in FIG.
`16, When the ?rst 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
`crimping bore 15 maintains its substantially circular cross
`sectional diameter When ?rst 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
`
`

`

`US 6,364,870 B1
`
`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 an alternative embodiment of the
`invention in Which a ?rst catheter protector 60 and a second
`catheter protector and stent positioner 61 is utiliZed to
`protect the catheter shaft and also to limit the movement of
`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