(12) United States Patent
`Austin
`
`I IIIII IIIIIIII Ill lllll lllll lllll lllll lllll lllll lllll lllll 111111111111111111
`US00682357 6B2
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 6,823,576 B2
`Nov. 30, 2004
`
`(54) METHOD AND APPARATUS FOR
`CONTRACTING, LOADING OR CRIMPING
`SELF-EXPANDING AND BALLOON
`EXPANDABLE STENT DEVICES
`
`(75)
`
`Inventor: Michael Austin, Co. Galway (IE)
`
`(73) Assignee: SciMed Life Systems, Inc., Maple
`Grove, MN (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by O days.
`
`3,416,352 A
`3,664,213 A
`3,695,087 A
`3,731,518 A
`4,164,523 A *
`4,413,989 A
`4,434,645 A
`4,456,000 A
`4,490,421 A
`4,578,982 A *
`RE32,983 E
`
`12/1968
`5/1972
`* 10/1972
`5/1973
`8/1979
`11/1983
`3/1984
`6/1984
`12/1984
`4/1986
`7/1989
`
`Rib back .. ... ... ... .. ... ... ... 72/121
`Anati ............................ 81/91
`Tuberman ... ... ... .. ... ... ... 72/402
`Blocher ... ... ... ... .. ... ... ... 72/402
`Hanning . . . . . . . . . . . . . . . . . . . . . . 264/28
`Schjeldahl et al.
`........... 604/96
`Svercl et al.
`................. 72/402
`Schjeldahl et al.
`. ... .. ... ... 128/1
`Levy . ... ... ... ... ... .. ... ... ... 428/35
`Schrock ... ... ... ... .. ... ... ... 72/402
`Levy ....................... 428/36.92
`
`(List continued on next page.)
`
`FOREIGN PATENT DOCUMENTS
`
`(21) Appl. No.: 09/966,686
`
`(22) Filed:
`
`Oct. 1, 2001
`
`(65)
`
`Prior Publication Data
`
`US 2002/0035774 Al Mar. 28, 2002
`
`Related U.S. Application Data
`
`DE
`DE
`EP
`EP
`EP
`WO
`WO
`WO
`WO
`
`295 06 654.7
`195 32 288 Al
`0 630 623 A2
`0 701 800 Al
`935 952 A2
`90/00098
`96/03092
`97/20593
`98/19633
`
`7/1995
`3/1997
`12/1994
`3/1996
`8/1999
`1/1990
`2/1996
`12/1997
`5/1998
`
`(63) Continuation of application No. 09/401,218, filed on Sep.
`22, 1999, now Pat. No. 6,360,577.
`Int. Cl.7 ........................... B23P 11/00; B21D 41/00
`(51)
`(52) U.S. Cl. ............................. 29/516; 29/515; 72/402;
`72/121
`(58) Field of Search .......................... 29/505, 516, 515,
`29/508, 283.5, 282, 237, 751; 606/1; 72/402,
`121; 425/DIG. 110, DIG. 9, 547, 551, 552
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
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`758,195 A
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`
`8/1896
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`12/1932
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`5/1959
`5/1961
`4/1963
`
`Boyd ... ... ... .. ... ... ... ... .. . 72/402
`Schweinert et al.
`.......... 72/402
`Ekman ........................ 72/402
`Smith et al. .................. 72/402
`Wolf . ... ... ... .. ... ... ... ... .. . 72/402
`Latin et al. .................... 207/4
`Latin et al. ................... 72/121
`Macleod .. ... .. ... ... ... ... .. ... 153/1
`Doyle ........................ 264/522
`
`OTHER PUBLICATIONS
`
`Hawley's Condensed Chemical Dictionary, p. 873, 1993.
`
`Primary Examiner-Marc Jimenez
`(74) Attorney, Agent, or Firm-Vidas, Arrett & Steinkraus
`
`(57)
`
`ABSTRACT
`
`An apparatus for manipulating a medical device is formed of
`at least three coupled movable blades which are disposed
`about a reference circle to form an aperture whose size may
`be varied. The aperture capable of being sized to contain a
`medical device. Each blade is in communication with an
`actuation device which is capable of moving the blade to
`alter the size of the aperture. Each blade includes a single
`radial point which a) lies on the circumference of the
`reference circle prior to movement of the blade, and b) may
`be moved only along a radius of the reference circle on
`movement of the blade.
`
`32 Claims, 15 Drawing Sheets
`
`Page 1 of 23
`
`Edwards Lifesciences v. Boston Scientific Scimed
`U.S. Patent No. 6,915,560
`IPR2017-00072 EX. 2014
`
`

`

`US 6,823,576 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
`8/1989 Eisenzimmer ............... 72/402
`4,854,031 A
`3/1990 Pinchuk et al. ............. 606/194
`4,906,244 A
`4,942,756 A * 7/1990 Charzewski ................. 72/402
`RE33,561 E
`3/1991 Levy ....................... 428/36.92
`5,026,377 A
`6/1991 Burton et al.
`5,087,394 A
`2/1992 Keith
`5,108,415 A
`4/1992 Pinchuk et al. ............. 606/194
`5,156,612 A
`10/1992 Pinchuk et al. ............. 606/194
`5,163,989 A
`11/1992 Campbell et al. ............. 65/110
`2/1993 Timmermans ............... 140/89
`5,183,085 A
`5,195,350 A
`3/1993 Aikens et al.
`................ 72/402
`5,261,263 A
`11/1993 Whitesell ..................... 72/402
`5,270,086 A
`12/1993 Hamlin
`5,290,305 A
`3/1994 Inoue
`5,304,340 A
`4/1994 Downey
`5,334,146 A
`8/1994 Ozasa
`5,338,172 A * 8/1994 Williamson et al. ........ 425/143
`5,358,486 A
`10/1994 Saab
`5,381,686 A
`1/1995 Thorup
`5,411,521 A
`5/1995 Putnam et al.
`5,437,083 A
`8/1995 Williams et al.
`5,509,184 A
`4/1996 Herrero
`5,545,210 A * 8/1996 Hess et al. ..................... 623/1
`5,546,646 A
`8/1996 Williams et al. ......... 29/407.08
`5,591,222 A
`1/1997 Susawa et al.
`5,626,604 A
`5/1997 Cottone, Jr.
`................ 606/198
`5,628,754 A
`5/1997 Shevlin et al.
`5,630,830 A
`5/1997 Verbeek
`5,672,169 A
`9/1997 Verbeek
`5,700,285 A * 12/1997 Myers et al. .................. 623/1
`2/1998 Owens ........................ 72/402
`5,715,723 A
`5,725,519 A
`3/1998 Penner et al. .................. 606/1
`5,738,674 A
`4/1998 Williams et al.
`5,746,644 A
`5/1998 Cheetham
`5,746,764 A
`5/1998 Green et al.
`5,749,921 A
`5/1998 Lenker et al.
`5,766,057 A
`6/1998 Maack
`5,766,203 A
`6/1998 Imran et al.
`
`8/1998 Hijlkema .................... 264/530
`5,792,415 A
`9/1998 Wang et al.
`................ 264/520
`5,807,520 A
`9/1998 Tuckey et al.
`5,810,871 A
`9/1998 Morales ...................... 606/198
`5,810,873 A
`5,836,952 A * 11/1998 Davis et al.
`................... 606/1
`5,836,965 A
`11/1998 Jendersee et al.
`5,860,966 A
`1/1999 Tower
`5,893,852 A * 4/1999 Morales ...................... 606/108
`5,893,867 A
`4/1999 Bagaoisan et al.
`.............. 623/1
`5,911,752 A
`6/1999 Dustrude et al.
`5,920,975 A
`7/1999 Morales ....................... 29/282
`5,931,851 A
`8/1999 Morales ...................... 606/194
`5,935,476 A * 8/1999 Langstedt ............ 425/174.8 R
`5,951,540 A
`9/1999 Verbeek ......................... 606/1
`5,974,652 A
`11/1999 Kimes et al.
`................. 29/516
`5,992,000 A * 11/1999 Humphrey et al.
`........... 29/516
`6,009,614 A * 1/2000 Morales ....................... 29/516
`.. ... ... ... .. 29/407.01
`6,018,857 A
`2/2000 Duffy et al.
`6,024,737 A
`2/2000 Morales ......................... 606/1
`6,033,380 A
`3/2000 Butaric et al. ................ 604/96
`6,051,002 A
`4/2000 Morales ...................... 606/108
`6,063,092 A
`5/2000 Shin ........................... 606/108
`6,063,102 A
`5/2000 Morales ...................... 606/198
`6,074,381 A * 6/2000 Dinh et al.
`... ... ... ... .. ... ... 606/1
`6,092,273 A
`7/2000 Villareal ...................... 29/516
`6,108,886 A
`8/2000 Kimes et al.
`................. 29/280
`6,125,523 A
`10/2000 Brown et al. ................. 29/516
`6,141,855 A
`11/2000 Morales ....................... 29/516
`6,167,605 Bl * 1/2001 Morales ....................... 29/282
`6,176,116 Bl * 1/2001 Wilhelm et al.
`......... 72/409.12
`6/2001 Kimes et al.
`................. 29/516
`6,240,615 Bl
`6,296,655 Bl
`10/2001 Gaudoin et al.
`............ 606/194
`6,303,071 Bl * 10/2001 Sugawara et al.
`.......... 425/526
`6,309,383 Bl * 10/2001 Campbell et al. .............. 606/1
`3/2002 Austin .. ... ... ... ... .. ... ... ... 72/402
`6,360,577 B2
`6,364,870 Bl * 4/2002 Pinchasik .................... 29/516
`6,387,117 Bl * 5/2002 Arnold et al.
`................ 72/416
`6,568,235 Bl * 5/2003 Kokish . ... ... ... ... .. ... ... ... 72/402
`* cited by examiner
`
`Page 2 of 23
`
`

`

`U.S. Patent
`
`Nov. 30, 2004
`
`Sheet 1 of 15
`
`US 6,823,576 B2 2B675,328,6SU
`
`Page 3 of 23
`
`

`

`U.S. Patent
`
`Nov. 30, 2004
`
`Sheet 2 of 15
`
`US 6,823,576 B2
`
`100
`~
`
`FIG. 2a
`
`100
`~
`
`110
`
`I I
`
`126
`
`FIG. 2b
`
`Page 4 of 23
`
`

`

`U.S. Patent
`
`Nov. 30, 2004
`
`Sheet 3 of 15
`
`US 6,823,576 B2
`
`111
`
`166
`
`FIG. 3a
`
`FIG. 3b
`
`FIG. 3c
`
`Page 5 of 23
`
`

`

`U.S. Patent
`
`Nov. 30, 2004
`
`Sheet 4 of 15
`
`US 6,823,576 B2
`
`138
`
`~
`
`-------
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`I
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`l
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`FIG. 4A
`
`Page 6 of 23
`
`

`

`U.S. Patent
`
`Nov. 30, 2004
`
`Sheet 5 of 15
`
`US 6,823,576 B2
`
`r+4c
`I
`142
`
`FIG. 4b
`
`156
`
`~""7'7'-~~ 153
`~~~ 151
`150
`
`216
`
`216
`
`130
`
`106
`FIG. 4c
`
`Page 7 of 23
`
`

`

`U.S. Patent
`
`Nov. 30, 2004
`
`Sheet 6 of 15
`
`US 6,823,576 B2
`
`142
`
`I I I I
`
`FIG. 5a
`
`130
`
`\
`106
`
`131
`
`131
`
`FIG. 5b
`
`Page 8 of 23
`
`

`

`U.S. Patent
`
`Nov. 30, 2004
`
`Sheet 7 of 15
`
`US 6,823,576 B2
`
`106
`
`FIG. 6
`160
`
`FIG. 7
`
`Page 9 of 23
`
`

`

`U.S. Patent
`
`Nov. 30, 2004
`
`Sheet 8 of 15
`
`US 6,823,576 B2
`
`156
`
`154b
`
`142
`
`154a
`
`156
`
`150
`
`130b
`
`130a
`
`178
`
`·106
`
`162
`
`180
`
`106
`
`130
`
`130
`
`150
`
`154
`
`154
`
`FIG. 8a
`
`Page 10 of 23
`
`

`

`U.S. Patent
`
`Nov. 30, 2004
`
`Sheet 9 of 15
`
`US 6,823,576 B2
`
`156
`
`1541.7
`
`154a
`
`156
`
`150
`
`162
`
`130b
`
`130a
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`106
`178
`I - - - - -L . . .__ - -~ - - - - - -1 174
`
`180-m
`
`106
`
`130
`
`130
`
`150
`
`154
`
`142
`
`154
`
`FIG. 8b
`
`Page 11 of 23
`
`

`

`U.S. Patent
`
`Nov. 30, 2004
`
`Sheet 10 of 15
`
`US 6,823,576 B2
`
`156
`
`154b
`
`154a
`
`156
`
`142
`
`150~ _
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`130b
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`178
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`106
`
`184
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`106
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`130
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`
`150
`
`142
`
`FIG. 8c
`
`154
`
`Page 12 of 23
`
`

`

`U.S. Patent
`U.S. Patent
`
`Nov. 30, 2004
`Nov. 30, 2004
`
`Sheet 11 of 15
`Sheet 11 of 15
`
`US 6,823,576 B2
`US 6,823,576 B2
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`Page 13 of 23
`
`Page 13 of 23
`
`

`

`U.S. Patent
`
`Nov. 30, 2004
`
`Sheet 12 of 15
`
`US 6,823,576 B2
`
`100c
`
`;ii
`
`154c
`
`100b
`
`~
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`100a
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`142a
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`156a
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`142c 142b
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`106b
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`180
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`106a 130a
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`
`156c
`
`156b 142a
`
`FIG.10
`
`Page 14 of 23
`
`

`

`U.S. Patent
`
`Nov. 30, 2004
`
`Sheet 13 of 15
`
`US 6,823,576 B2
`
`180
`
`L . . -1 - - - - - - - '
`
`196
`
`188
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`1 ,o~b I ~1 ..:;::s :::::;1 __ _
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`
`FIG. 11
`
`Page 15 of 23
`
`

`

`U.S. Patent
`
`Nov. 30, 2004
`
`Sheet 14 of 15
`
`US 6,823,576 B2
`
`100
`~
`
`156
`
`154b
`
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`
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`
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`FIG. 12
`
`Page 16 of 23
`
`

`

`U.S. Patent
`
`Nov. 30, 2004
`
`Sheet 15 of 15
`
`US 6,823,576 B2
`
`100c
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`
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`
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`
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`
`FIG.13
`
`Page 17 of 23
`
`

`

`US 6,823,576 B2
`
`1
`METHOD AND APPARATUS FOR
`CONTRACTING, LOADING OR CRIMPING
`SELF-EXPANDING AND BALLOON
`EXPANDABLE STENT DEVICES
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`This application is a Continuation application from appli(cid:173)
`cation Ser. No. 09/401,218 filed Sep. 22, 1999 now U.S. Pat.
`No. 6,360,577, the contents of which is incorporated herein
`by reference.
`
`BACKGROUND OF THE INVENTION
`
`This invention relates to an apparatus and a method for
`reducing in size a medical device such as a stent, stent-graft,
`graft, or vena cava filter. The apparatus may be used in
`particular for fastening a medical device onto a catheter.
`Medical devices such as stents, stent-grafts, grafts, or
`vena cava filters and catheters for their delivery are utilized 20
`in a number of medical procedures and situations, and as
`such their structure and function are well known.
`A stent, for example, is a generally cylindrical prosthesis
`introduced via a catheter into a lumen of a body vessel in a
`configuration having a generally reduced diameter and then 25
`expanded to the diameter of the vessel. In its expanded
`configuration, the stent supports and reinforces the vessel
`walls while maintaining the vessel in an open, unobstructed
`condition.
`Stents are typically inflation expandable or self- 30
`expanding. Self expanding stents which are constrained by
`a sheath or other restaining means, must be provided in a
`reduced diameter.
`An example of a stent described in PCT Application No.
`960 3092 Al, published 8 Feb. 1996.
`In advancing a stent through a body vessel to the deploy(cid:173)
`ment site, the stent must be able to securely maintain its axial
`position on the delivery catheter, without translocating
`proximally or distally, and especially without becoming
`separated from the catheter. Stents that are not properly
`secured or retained to the catheter may slip and either be lost
`or be deployed in the wrong location. The stent must be
`crimped in such a way as to minimize or prevent altogether
`distortion of the stent and to thereby prevent abrasion and/or
`reduce trauma of the vessel walls.
`In the past, this crimping or size reduction has been done
`by hand often resulting in the application of undesired
`uneven forces to the stent. Such a stent must either be
`discarded or re-crimped. Stents which have been crimped or
`otherwise reduced in size multiple times can suffer from
`fatigue and may be scored or otherwise marked which can
`cause thrombosis. A poorly crimped stent can also damage
`the underlying balloon.
`Recently, stent crimping devices have been disclosed in 55
`U.S. Pat. No. 5,546,646 to Williams et al, U.S. Pat. No.
`5,183,085 to Timmermans et al., U.S. Pat. No. 5,626,604 to
`Cottone, Jr., U.S. Pat. No. 5,725,519, U.S. Pat. No. 5,810,
`873 to Morales, WO 97/20593 and WO 98/19633.
`A cam actuated stent crimper, shown in FIG. 1, employs
`a plurality of arc-shaped or curved slots with semi-circular
`ends, disposed such that each slot or cam engages a cam
`follower bearing 22. The arc-shaped or curved surfaces of
`the slots are inclined to be non-concentric relative to the axis
`of rotation 26, and therefore rotation of the cam plate 28 65
`transmits equal radial displacements to the cam follower
`bearings 22, to simultaneously actuate a like number of
`
`2
`linear bearings 24, which have their corresponding linear
`tracks or rails mounted on a fixed plate. As shown in FIG.
`1 the cam plate rotary drive 29 comprises a pneumatic
`cylinder mounted on a pivot or trunnion, arranged with the
`5 cylinder rod connected rotatably to a short arm fixed rigidly
`to the cam plate. Accordingly, linear motion produced by the
`pneumatic cylinder translates into controllable arcs of
`motion of the circular cam plate, which has a projecting
`V-shaped profile on its outer edge in rolling engagement
`10 with three equally spaced rollers with mating inverse
`V-shaped profiles to provide precise rotatable support to the
`cam plate. Depending on the direction of rotation, the linear
`slides which each carry a radially disposed crimping blade,
`are either moved inwards to apply a crimping force to the
`15 stent, or outwards to release the stent. Also when crimping,
`depending on the degree of rotation of the cam plate, a
`specific radial crimping displacement may be obtained to
`match the diametral reduction required for any particular
`stent.
`All US patents and applications and all other published
`documents mentioned anywhere in this application are
`incorporated herein by reference in their entirety.
`
`BRIEF SUMMARY OF THE INVENTION
`
`35
`
`It would be desirable to produce a device capable of
`crimping a stent uniformly while minimizing the distortion
`of and scoring and marking of the stent due to the crimping.
`The present invention is directed to that end.
`The present invention is particularly concerned with the
`crimping and otherwise reducing in size of inflation expand(cid:173)
`able stents, self-expanding stents and other expandable
`medical devices. For the purpose of this disclosure, it is
`understood that the term 'stent' includes stents, stent-grafts,
`grafts and vena cava filters. It is also understood that the
`term 'crimping' refers to a reduction in size or profile of a
`stent.
`In the description that follows it is understood that the
`invention contemplates crimping a medical device either
`40 directly to a catheter tube or to a catheter balloon which is
`disposed about a catheter tube. When reference is made to
`crimping a medical device to a catheter, a balloon may be
`situated between the medical device and the catheter tube or
`the medical device may be crimped to a region of a catheter
`45 tube directly. The invention also contemplates crimping a
`stent in the absence of a catheter to reduce the stent in size.
`The present invention is directed, in one embodiment, to
`an apparatus for reducing a medical device in size.
`Desirably, the medical device is a stent, a stent-graft, a graft
`50 or a vena cava filter, whether self-expandable, balloon
`expandable or otherwise expandable, although the inventive
`apparatus may also be employed with any other suitable,
`generally tubular medical device which must be reduced in
`size.
`The inventive apparatus comprises at least three coupled
`movable blades disposed about a reference circle to form an
`aperture whose size may be varied. Each blade is in com(cid:173)
`munication with an actuation device which is capable of
`moving the blade to alter the size of the aperture. Each blade
`60 includes a single radial point on the surface of the blade
`which a) lies on the circumference of the reference circle
`prior to movement of the blade, and b) may be moved only
`along a radius of the reference circle on movement of the
`blade.
`The apparatus further includes an actuation device which
`comprises a cam and a plurality of linear slide devices. Each
`linear slide device is in communication with a blade. Each
`
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`US 6,823,576 B2
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`5
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`20
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`3
`of the linear slide devices is also in mechanical communi(cid:173)
`cation with the cam. Rotation of the cam results in linear
`translation of the slide device and blade, such that the slide
`device moves along an axis parallel to the radius on which
`the radial point of the blade lies or along the radius itself.
`The invention is also directed to an apparatus similar to
`that described above, with blades disposed about a reference
`tube to form a tubular aperture whose size may be varied.
`Each blade is in communication with an actuation device
`which is capable of moving the blade to alter the size of the 10
`tubular aperture. Each blade includes a single line which a)
`lies on the surface of the reference tube prior to movement
`of the blade, and b) may be moved only along a radial plane
`of the reference tube on movement of the blade.
`The inventive apparatus finds particular utility in crimp- 15
`ing a medical device such as those mentioned above to a
`catheter or to a balloon disposed about a catheter.
`The inventive apparatus also finds utility in reducing the
`diameter of a medical device such as those mentioned above
`prior to crimping.
`The invention is also directed to a method of manipulating
`a medical device which comprises the steps of providing the
`medical device and providing at least three blades capable of
`applying a radial inward force. The blades are disposed 25
`about a reference circle to form a shrinkable aperture. A
`medical device such as a stent is placed into the shrinkable
`aperture and the blades simultaneously moved inward to
`apply a radial inward force to the medical device. The blades
`are constructed and arranged such that each blade has a 30
`single point which a) lies on the circumference of the
`reference circle prior to movement of the blade, and b) is
`moved along a radius of the reference circle on movement
`of the blade.
`The inventive apparatus may also be used as a variable 35
`size balloon mold. To that end, the invention is further
`directed to a method of molding a medical balloon. In the
`practice of the method, a balloon preform prepared through
`any suitable technique known in the art is provided. The
`preform is placed in an apparatus which has a shrinkable 40
`tubular aperture formed by at least three movable blades
`disposed about a reference tube. The blades are constructed
`and arranged such that each blade has a single line which a)
`lies on the surface of the reference tube prior to movement
`of the blade, and b) is moved along a radial plane of the 45
`reference tube on movement of the blade. The aperture may
`be set to a predetermined size prior to placement of the
`preform therein or after placement of the preform therein.
`An inflation fluid is supplied to the balloon preform to
`expand the balloon preform until it contacts the blades. The 50
`reform may optionally be heated prior to, during or after the
`blowing step. The thus formed balloon is then pressure
`relieved and removed from the apparatus.
`
`4
`FIG. 4b is a partial front view of an embodiment of the
`inventive apparatus;
`FIG. 4c shows a side view of the embodiment of FIG. 4b
`taken along lines 4c-4c;
`FIG. Sa shows a partial front view of another embodiment
`of the inventive apparatus;
`FIG. Sb shows a link connected to a blade;
`FIG. 6 is a schematic, perspective view of an embodiment
`of the inventive apparatus;
`FIG. 7 shows a partial view of the embodiment of FIG. 6;
`FIGS. Sa and Sb are partial side elevational views of an
`embodiment of the inventive apparatus taken along a radial
`plane during the size reduction process;
`FIG. Sc is a partial side elevational view of an embodi(cid:173)
`ment of the inventive apparatus taken along a radial plane
`following crimping of a stent to a catheter;
`FIG. 9 is a diagrammatic side elevational view of an
`embodiment of the inventive apparatus;
`FIG. 10 is a partial side elevational view of an embodi(cid:173)
`ment of the inventive apparatus taken along a radial plane of
`an embodiment of the invention consisting of three indi(cid:173)
`vidual apparatuses arranged sequentially;
`FIG. 11 is a schematic showing a stent being reduced in
`size and loaded into a sheath;
`FIG. 12 is a partial side elevational view of an embodi(cid:173)
`ment of the inventive apparatus taken along a radial plane
`showing a balloon that has been molded with the inventive
`device; and
`FIG. 13 is a partial side elevational view taken along a
`radial plane showing a stepped balloon that has been molded
`with the inventive device.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`While this invention may be embodied in many different
`forms, there are described in detail herein specific preferred
`embodiments of the invention. This description is an exem(cid:173)
`plification of the principles of the invention and is not
`intended to limit the invention to the particular embodiments
`illustrated.
`As shown generally at 100 in FIGS. 2a and 2b, the
`inventive apparatus comprises eight coupled blades 106
`disposed about a reference circle 114 to form an aperture 118
`whose size may be varied. The apparatus may comprise as
`few as three blades and as many as sixteen or more blades.
`Desirably, the apparatus will have four or more blades and
`more desirably, eight or more blades. The maximum number
`of blades is limited only by how many blades can physically
`be coupled together under the relevant size constraints. As
`the number of blades is increased, the profile of the aperture
`and hence of the medical device following reduction in size,
`55 becomes smoother. FIG. 2b shows the apparatus of FIG. 2a
`after the stent has been reduced in size.
`Blades 106 as shown in FIG. 3a have an inner end 108
`which is desirably beveled 111 so as to mesh with adjacent
`blades and an outer end 110 which is displaced from aperture
`118. Aperture 118 is polygonal. Blades 106 may also be
`shaped with a curved end 112, as shown in FIGS. 3b and 3c
`so as to form a substantially circular shaped aperture, when
`the aperture is fully closed.
`Each blade 106 includes a single radial point 122 which
`65 lies on a radial line 126 of reference circle 114 prior to
`movement of blade 106 and which may be moved only along
`the radius 126 of reference circle 114 on movement of blade
`
`BRIEF DESCRIPTION OF THE SEVERAL
`VIEWS OF THE DRAWING(S)
`FIG. 1 shows a perspective view of a stent crimper;
`FIG. 2a is a schematic front view of an embodiment of the
`inventive apparatus;
`FIG. 2b is a schematic front view of the embodiment of 60
`FIG. 2a after the stent has been reduced in size;
`FIGS. 3a and 3b are schematics of blades;
`FIG. 3c is a partial schematic front view of an embodi(cid:173)
`ment of the inventive apparatus employing the curved blades
`of FIG. 3b;
`FIG. 4a is a partial front view of an embodiment of the
`inventive apparatus;
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`US 6,823,576 B2
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`106. Desirably, the single radial point 122 will be disposed
`at the tip of the blade adjacent to beveled end 111.
`In the embodiment shown in FIG. 4a, radial point 122 lies
`at the tip of blade 106. Each blade 106 has a connecting link
`130 extending from second end 110. Connecting link 130 5
`ends in mounting means 134, typically a mounting flange
`adapted for attachment to a linear bearing block, for inter(cid:173)
`facing with an actuation device, shown generally at 138.
`Actuation device 138 is capable of simultaneously moving
`blades 106 to alter the size of aperture 118.
`Actuation device 138 includes actuation plate 142 which
`is coaxial with reference circle 114. Actuation plate 142 has
`eight equi-spaced radial slots 146. More generally, for every
`blade there will be a corresponding radial slot on actuation
`plate 142. Each radial slot 146 overlaps a mounting means 15
`134 for a linear bearing block at the end of a connecting link
`130. Each blade 106 is engaged to actuation plate 142 via a
`cam follower bearing 150 disposed in radial slot 146 and
`attached to mounting means in slotted end 134.
`Each bearing 150 extends from a linear slide 154. Linear 20
`slide 154 is mounted on a non-rotating plate 156 (shown in
`FIG. 8). Linear slide 154 is constructed and arranged to slide
`along a line 158 which is parallel to the radius 126 on which
`radial point 122 of blade 106 lies.
`For the purposes of this disclosure, the term 'cam follower
`bearing' includes cam follower bearings, low friction rollers,
`roller bearings, needle roller bearings and a slipper block
`pivot mounted on a bearing and stub shaft. FIG. 4b is a
`partial front view of an embodiment in which a slipper block 30
`is used. A side view of the embodiment of FIG. 4b taken
`along lines 4c is shown in FIG. 4c. Slipper block 150 resides
`in slot 146 of actuation plate 142. Slipper block 150 is
`mounted on stub shaft 151 which extends from connecting
`link 130. Desirably, bearings 153 will be present between
`shaft 151 and slipper block 150. Connecting link 130, in
`turn, is fastened to linear bearing block 212 via fasteners
`214. Bearing block 212 is linearly mounted on linear slide
`which is mounted on fixed plate 156. Linear motion is
`facilitated by the presence of bearings 216.
`Cam follower bearing 150 may be replaced by any other
`suitable connecting member which can connect the slide and
`the link.
`In use, as actuation plate 142 is rotated in a clockwise
`direction, the clockwise motion of the actuation plate is 45
`translated into linear motion of each of linear slide 154 and
`blade 106 via bearing 150. Each blade 106 moves outward
`in a direction parallel to the radius 126 on which the radial
`point 122 of the blade 106 lies, resulting in the opening of
`aperture 118. As actuation plate 142 is rotated in a counter- 50
`clockwise direction, each blade 106 moves inward in a
`direction parallel to the radius 126 on which the radial point
`122 of the blade 106 lies, resulting in the closing of aperture
`118. As aperture 118 closes, a radially inward force is
`applied to a medical device disposed in the aperture. The 55
`actuation plate is rotated until the desired size reduction of
`the aperture and medical device has been achieved. Follow(cid:173)
`ing the reduction, the actuation plate is rotated in the
`opposite direction to allow for removal of the medical
`device from the aperture.
`The apparatus may be used to reduce the diameter of a
`suitable medical device such as those disclosed above or
`may be used to crimp a medical device to a catheter.
`Another embodiment of the invention is shown in FIG.
`Sa. Each blade 106, as shown in FIG. Sa, has a connecting 65
`link 130 extending therefrom. Connecting link 130 is rigidly
`attached to blade 106. Connecting link 130 ends in an angled
`
`6
`end 134 for interfacing with an actuation device, shown
`generally at 138. Actuation device 138 is capable of simul(cid:173)
`taneously moving blades 106 to alter the size of aperture
`118.
`Actuation device 138 includes a rotatable actuation plate
`142 which is co-axial with reference circle 114. Rotatable
`actuation plate includes cam slots 146 which are not con(cid:173)
`centric with the axis of rotation, arcing inward. Each con(cid:173)
`necting link 130 is engaged to actuation plate 146 via a cam
`10 follower bearing 150 disposed in slot 146 and attached to
`both angled end 134 of connecting link 130 and to a linear
`slide 154. Linear slide 154 is mounted on a non-rotating
`plate similar to that shown in FIG. 8. Linear slide 154 is
`constructed and arranged to slide along a radial line 158 on
`which radial point 122 of blade 106 lies.
`Connecting link 130 may be bonded adhesively, welded,
`joined with a fastener or otherwise joined to blade 106. As
`shown in FIG. Sa, a single screw 131 is used to connect link
`130 to blade 106. FIG. Sb shows a connecting link 130
`including a right angle portion which is fastened to a blade
`106 using two screws 131. Connecting link 130 and blade
`106 may optionally be formed of a single piece of material.
`Regardless of how the connecting member is joined to the
`blade, no movement of the blade relative to the connecting
`25 link is permitted.
`In use, as actuation plate 142 is rotated in a clockwise
`direction, the clockwise motion of the actuation plate is
`translated into a linear outward motion of ach of linear slides
`154 and blades 106 via bearings 150 resulting in the opening
`of aperture 118. The outward motion results from the
`radially outward arcing of cam slot 146. As actuation plate
`142 is rotated in a counterclockwise direction, each blade
`106, because of the radially inward arc of cam slots 146,
`moves inward in a direction parallel to the radius 126 on
`35 which the radial point 122 of the blade 106 lies, resulting in
`the closing of aperture 18. As discussed above, as the
`aperture is decreased in size, a radial inward force is brought
`to bear against a medical device disposed in the aperture,
`thereby reducing the size of the medical device.
`The embodiment of FIG. Sa differs from the embodiment
`of FIG. 4a in that in the embodiment of FIG. Sa, the slide
`moves along the radial line on which the radial point of the
`attached blade lies whereas in FIG. 4a the slide moves
`parallel to the radial line. In both of the embodiments, each
`of the blades is constrained with two degrees of freedom to
`satisfy the condition that the movement of the tip be radial
`in accordance with the invention.
`In the embodiments of FIGS. 4a and Sa, the slots in the
`actuation plate are constructed and arranged to allow for a
`sufficient reduction in size of the aperture so that a medical
`device can be reduced in size to a desired diameter. Those of
`ordinary skill in the art will recognize other suitable actua(cid:173)
`tion devices that may be used in the practice of this inven-
`tion.
`Desirably, in the above embodiments, the blades will be
`as long as or longer than the medical device disposed within
`so that the medical device is uniformly reduced in size along
`its entire length.
`This is illustrated in the embodiment of FIGS. 6 and 7 and
`further in FIGS. 3a and 3b in which blades 106 are disposed
`about a reference tube 160 to form a tubular aperture 162
`whose size may be varied. Reference circle 114 is seen to lie
`along reference tube 160. Each blade 106 is in communi(cid:173)
`cation with an actuation device such as that shown in FIG.
`4 or 5. The actuation device is capable of moving blades 106
`to alter the size of tubular aperture 162. Each blade 106
`
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`US 6,823,576 B2
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`includes a single line 166 which a) lies on a radial plane 170
`of the reference tube 160 prior to movement of blade 106,
`and b) may be moved only along a radial plane 170 of
`reference tube 160 on movement of blade, 106. Desirably,
`reference tube 160 is cylindrical and exceeds the length of 5
`the medical device to be reduced in size.
`Another embodimen