(12) United States Patent
`Austin
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 6,915,560 B2
`Jul. 12, 2005
`
`US006915560B2
`
`(54) APPARATUS FOR CONTRACTING,
`LOADING 0R CRIMPING
`
`SELF_EXPANDING AND BALLOON
`
`EXPANDABLE STENT DEVICES
`
`3,084,389 A * 4/1963 Doyle ...................... .. 264/522
`3,416,352 A * 12/1968 Ribback .
`72/121
`
`3,664,213 A * 5/1972 Anati . . . . . . . .
`3,695,087 A * 10/1972 Tuberman ..
`3,731,518 A
`5/1973 Blocher
`
`. . . . .. 81/91
`72/402
`72/402
`
`_
`.
`.
`(75) Inventor‘ Mlchael Austm’ CO‘ Galway (IE)
`
`4,164,523 A * 8/1979 Hanning ............ ..
`4,413,989 A 11/1983 Schjeldahl 6t al.
`
`264/28
`604/96
`
`.
`
`(73) AsslgneeZ Boston Sclentl?c sclMed’ 111% Maple
`Grove, MN (US)
`
`.
`
`.
`
`.
`
`4,434,645 A
`
`3/1984 Svercl et al. . . . . . . . . .
`
`. . . .. 72/402
`
`.... .. 128/1
`6/1984 Schjeldahl ct al.
`4,456,000 A
`4,490,421 A 12/1984 Levy ......................... .. 428/35
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U'S'C. 154(k)) by 0 days‘
`
`(21) APPL NO; 10/444,807
`
`(22) Filed:
`
`May 23, 2003
`
`(65)
`
`Prior Publication Data
`
`US 2003/0192164 A1 Oct. 16, 2003
`
`Related US. Application Data
`
`(COHIiHIlfId)
`
`FOREIGN PATENT DOCUMENTS
`295 06 654.7
`7/1995
`195 32 288 A1
`3/1997
`0 630 623 A2 12/1994
`0 701 800 A1
`3/1996
`935 952 A2
`8/1999
`90/00098
`1/1990
`96/03092
`2/1996
`9700593
`12/1997
`98/19633
`5/1998
`
`OTHER PUBLICATIONS
`
`DE
`DE
`EP
`EP
`EP
`WO
`WO
`W0
`WO
`
`(62) Division of application No. 09/966,686, ?led on Oct. 1,
`2001, now Pat. No. 6,823,576, which is a continuation of
`application No. 09/401,218, ?led on Sep. 22, 1999, now Pat.
`NO. 6,360,577.
`
`(51) Int. Cl.7 ......................... .. B23P 21/00; B23P 11/00
`(52) US. Cl. ........................... .. 29/722; 29/516; 29/508;
`72/402
`(58) Field of Search ............................ .. 29/283.15, 751,
`29/516, 237, 243, 517, 508, 283.5; 72/402;
`606/1
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`8/1896 Boyd ........................ .. 72/402
`565,257 A
`4/1904 Schweinert et al. ........ .. 72/402
`758,195 A
`1,665,915 A * 4/1928 Ekman ...................... .. 72/402
`1,889,795 A * 12/1932 Smith et al. .
`..... .. 72/402
`2,292,421 A * 8/1942 Wolf ............ ..
`72/402
`2,751,077 A
`6/1956 Latin etal.
`207/4
`2,887,222 A * 5/1959 Latin et al.
`72/121
`2,986,192 A
`5/1961 Macleod ...................... .. 153/1
`
`U.S. Appl. No. 09/966,686, Austin, ?led Oct. 1, 2001.
`HaWley’s Condensed Chemical Dictionary, p. 873, 1993.
`US. Appl. No. 09/401,218, Austin, ?led Sep. 22, 1999.
`
`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.
`
`40 Claims, 15 Drawing Sheets
`
`Page 1 of 24
`
`EDWARDS LIFESCIENCES EX. 1201
`Edwards Lifesciences v. Boston Scientific Scimed
`U.S. Patent No. 6,915,560
`
`

`

`US 6,915,560 B2
`Page 2
`
`US. PATENT DOCUMENTS
`*
`
`4,578,982 A
`i *
`
`*
`
`4/1986 Schrock ..................... .. 72/402
`Iéevy .~ .................... .. 4287/3633
`lsenzlmmer '
`/
`/
`7
`’
`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
`.
`5,183,085 A
`2/1993 Timmermans
`.. 140/89
`.
`5,195,350 A
`3/1993 A1kens et al. .............. .. 72/402
`.
`5,261,263 A * 11/1993 Whitesell ............... .. 72/409.19
`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 “V1994 Saab
`5’381’686 A
`1/1995 Thom
`’
`’
`p
`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
`.
`.
`8/1996 Williams et al. ....... .. 29/407.08
`5,546,646 A
`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 Shevlm et al.
`5/1997 Verbeek
`5 630 830 A
`’
`’
`9/1997 Verbeek
`5,672,169 A
`5 700 285 A 12/1997 Myers et a1‘
`5’715’723 A
`2/1998 Owens
`’
`’
`5,725,519 A
`5,738,674 A
`5,746,644 A
`5,746,764 A
`5,749,921 A
`5,766,057 A
`
`""""""""""" "
`3/1998 Penner et al. ..
`. 606/1
`.
`.
`4/1998 Williams et al.
`5/1998 Cheetham
`5/1998 Green et a1‘
`5/1998 Lenker et al.
`6/1998 Maack
`
`*
`
`6/1998 Imran et al.
`5,766,203 A
`8/1998 Hijlkema .................. .. 264/530
`5,792,415 A
`9/1998 Wang etal~ ~~~~~~~~~~~~~~ u 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 etal.
`.......... .. 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.
`5 911 752 A
`6/1999 Dustrude et al. ............ .. 623/1
`’
`’
`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
`6009 614 A * 1/2000 Morales ....... ..
`.. 29/516
`’
`’
`6,018,857 A
`2/2000 Duffy et al. .
`29/407.01
`6024 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
`’
`’
`_
`6092 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 B1
`1/2001 Morales
`606/1
`’
`’
`_
`6,176,116 B1
`1/2001 Wilhelm et al.
`72/409.12
`6,240,615 B1
`6/2001 Kimes etal.
`.. 29/516
`_
`6,296,655 B1
`10/2001 Gaudom et al.
`606/194
`6,303,071 B1 * 10/2001 Sugawara etal. .
`425/526
`6,309,383 B1 * 10/2001 Campbell etal.
`606/1
`_
`6360 577 B2 * 3/2002 Austin ...... ..
`’
`’
`.
`.
`6364 870 B1
`4/2002 Pinchasik
`6’568’235 B1 * 52003 K ki h
`,
`,
`/
`o s
`
`.. 72/402
`606/1
`72 402
`/
`
`...................... ..
`
`* cited by examiner
`
`72/402
`
`Page 2 of 24
`
`

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`U.S. Patent
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`Jul. 12,2005
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`Sheet 1 0f 15
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`US 6,915,560 B2
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`b2 MQML F GE
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`Page 3 of 24
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`U.S. Patent
`US. Patent
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`Jul. 12,2005
`Jul. 12, 2005
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`Sheet 2 0f 15
`Sheet 2 0f 15
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`US 6,915,560 B2
`US 6,915,560 B2
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`
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`Page 4 of 24
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`Page 4 of 24
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`U.S. Patent
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`Jul. 12,2005
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`Sheet 3 0f 15
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`US 6,915,560 B2
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`110
`
`106
`
`110
`
`106
`
`111
`
`108
`
`111
`
`106
`
`166
`FIG. 5a
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`112
`
`166
`
`FIG. 5b
`
`106
`
`111
`
`FIG. 50
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`Page 5 of 24
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`U.S. Patent
`US. Patent
`
`Jul. 12,2005
`Jul. 12, 2005
`
`Sheet 4 0f 15
`Sheet 4 0f 15
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`US 6,915,560 B2
`US 6,915,560 B2
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`
`
`FIG. 4A
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`Page 6 of 24
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`Page 6 of 24
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`

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`U.S. Patent
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`Jul. 12,2005
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`Sheet 5 0f 15
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`US 6,915,560 B2
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`I" 46142
`
`FIG. 4b
`
`106
`FIG. 40
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`Page 7 of 24
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`

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`US. Patent
`U.S. Patent
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`Jul. 12,2005
`Jul. 12, 2005
`
`Sheet 6 6f 15
`Sheet 6 0f 15
`
`US 6,915,560 B2
`US 6,915,560 B2
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`
`
`150
`
`@, @, x
`
`106
`
`151
`151
`FIG. 5b
`FIG. 5!?
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`Page 8 of 24
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`Page 8 of 24
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`

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`U.S. Patent
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`Jul. 12,2005
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`Sheet 7 0f 15
`
`US 6,915,560 B2
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`106
`
`106
`
`166
`
`162 —
`
`106f
`
`122
`
`FIG. 6
`160
`
`166
`
`170
`
`114
`
`106
`
`162
`
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`/
`'
`
`,1
`
`106
`
`122
`
`111
`
`Page 9 of 24
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`

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`US. Patent
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`Jul. 12, 2005
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`Sheet 8 0f 15
`
`US 6,915,560 B2
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`15
`
`16
`
`J.
`
`I
`
`
`
`
`
`FIG. 651
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`Page 10 of 24
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`Page 10 of 24
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`

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`U.S. Patent
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`Jul. 12,2005
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`Sheet 9 0f 15
`
`US 6,915,560 B2
`
`_M_ / \ m WM Y 7//////% J %////// w WL1|
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`FIG. 5b
`
`Page 11 of 24
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`U.S. Patent
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`Jul. 12,2005
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`Sheet 10 0f 15
`
`US 6,915,560 B2
`
`V
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`15614
`
`142
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`Page 12 of 24
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`US. Patent
`U.S. Patent
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`Jul. 12,2005
`Jul. 12, 2005
`
`Sheet 11 0f 15
`Sheet 11 0f 15
`
`US 6,915,560 B2
`US 6,915,560 B2
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`Page 13 of 24
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`Page 13 of 24
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`

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`U.S. Patent
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`Jul. 12,2005
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`Sheet 12 0f 15
`
`US 6,915,560 B2
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`1000
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`100a
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`Page 14 of 24
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`U.S. Patent
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`Jul. 12,2005
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`Sheet 13 0f 15
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`US 6,915,560 B2
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`Page 15 of 24
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`U.S. Patent
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`Jul. 12 2005
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`Sheet 14 0f 15
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`100
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`Page 16 of 24
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`

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`US. Patent
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`Jul. 12, 2005
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`Sheet 15 0f 15
`
`US 6,915,560 B2
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`1563
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`Page 17 of 24
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`

`

`US 6,915,560 B2
`
`1
`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
`cation Ser. No. 09/966,686 ?led Oct. 1, 2001 now US. Pat.
`No. 6,823,576 Which is a Continuation application from
`application Ser. No. 09/401,218 ?led Sep. 22, 1999, now
`US. Pat. No. 6,360,577, issued Mar. 26, 2002 the contents
`of Which are hereby incorporated 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 ?lter. 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 ?lters and catheters for their delivery are utiliZed
`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
`con?guration having a generally reduced diameter and then
`expanded to the diameter of the vessel. In its expanded
`con?guration, the stent supports and reinforces the vessel
`Walls While maintaining the vessel in an open, unobstructed
`condition.
`Stents are typically in?ation expandable or self
`expanding. Self expanding stents Which are constrained by
`a sheath or other restraining means, must be provided in a
`reduced diameter.
`An example of a stent described in PCT Application No.
`960 3092 A1, published Feb. 8, 1996.
`In advancing a stent through a body vessel to the deploy
`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
`US. Pat. No. 5,546,646 to Williams et al, US. Pat. No.
`5,183,085 to Timmermans et al., US. Pat. No. 5,626,604 to
`Coffone, Jr., US. Pat. No. 5,725,519, US. 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
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`55
`
`60
`
`65
`
`2
`transmits equal radial displacements to the cam folloWer
`bearings 22, to simultaneously actuate a like number of
`linear bearings 24, Which have their corresponding linear
`tracks or rails mounted on a ?xed 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
`cylinder rod connected rotatably to a short arm ?xed 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 pro?le on its outer edge in rolling engagement
`With three equally spaced rollers With mating inverse
`V-shaped pro?les 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
`stent, or outWards to release the stent. Also When crimping,
`depending on the degree of rotation of the cam plate, a
`speci?c 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
`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 in?ation expand
`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 ?lters. It is also understood that the
`term ‘crimping’ refers to a reduction in siZe or pro?le of a
`stent.
`In the description that folloWs it is understood that the
`invention contemplates crimping a medical device either
`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
`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
`or a vena cava ?lter, 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
`munication 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 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
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`linear slide device is in communication With a blade. Each
`of the linear slide devices is also in mechanical communi
`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
`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 ?nds particular utility in crimp
`ing a medical device such as those mentioned above to a
`catheter or to a balloon disposed about a catheter.
`The inventive apparatus also ?nds 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
`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
`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
`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
`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
`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 in?ation ?uid is supplied to the balloon preform to
`eXpand the balloon preform until it contacts the blades. The
`preform 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.
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`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
`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
`ment of the inventive apparatus employing the curved blades
`of FIG. 3b;
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`FIG. 4a is a partial front vieW of an embodiment of the
`inventive apparatus;
`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—c;
`FIG. 5a shoWs a partial front vieW of another embodiment
`of the inventive apparatus;
`FIG. 5b 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. 8a and 8b are partial side elevational vieWs of an
`embodiment of the inventive apparatus taken along a radial
`plane during the siZe reduction process;
`FIG. 8c is a partial side elevational vieW of an embodi
`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
`ment of the inventive apparatus taken along a radial plane of
`an embodiment of the invention consisting of three indi
`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
`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 speci?c preferred
`embodiments of the invention. This description is an eXem
`pli?cation 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 pro?le of the aperture
`and hence of the medical device folloWing reduction in siZe,
`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
`lies on a radial line 126 of reference circle 114 prior to
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`US 6,915,560 B2
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`movement of blade 106 and Which may be moved only along
`the radius 126 of reference circle 114 on movement of blade
`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
`ends in mounting means 134, typically a mounting ?ange
`adapted for attachment to a linear bearing block, for inter
`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
`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
`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
`is used. A side vieW of the embodiment of FIG. 4b taken
`along lines 4c—c 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 ?xed 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
`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
`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
`actuation plate is rotated until the desired siZe reduction of
`the aperture and medical device has been achieved. FolloW
`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.
`5a. Each blade 106, as shoWn in FIG. 5a, has a connecting
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`link 130 extending therefrom. Connecting link 130 is rigidly
`attached to blade 106. Connecting link 130 ends in an angled
`end 134 for interfacing With an actuation device, shoWn
`generally at 138. Actuation device 138 is capable of simul
`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
`centric With the axis of rotation, arcing inWard. Each con
`necting link 130 is engaged to actuation plate 146 via a cam
`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. 5a, a single screW 131 is used to connect link
`130 to blade 106. FIG. 5b 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
`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 each 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 Which the radial point 122 of the blade 106 lies, resulting
`in the closing of aperture 118. 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. 5a differs from the embodiment
`of FIG. 4a in that in the embodiment of FIG. 5a, 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 5a, 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
`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
`cation With an actuation device such as that shoWn in FIG.
`
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`4 or 5. The actuation device is capable of moving blades 106
`to alter the size of tubular aperture 162. Each blade 106
`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
`the medical device to be reduced in size.
`Another embodiment of the invention is illustrated in
`FIGS. 8a and 8b. In the embodiment of FIGS. 8a and 8b, two
`non-rotating plates 156 are present, one at each end of the
`apparatus. Each blade 106 is connected at first end 174 to a
`linear slide 154a via a connecting link 130a and at second
`end 178 to a linear slide 154b a via a connecting link 130b.
`Linear slide 154a is mounted on non-rotating