`(12) Patent Application Publication (10) Pub. No.: US 2005/0283231 A1
`(43) Pub. Date:
`Dec. 22, 2005
`Haug et al.
`
`US 20050283231A1
`
`(54) EVERTING HEART VALVE
`
`(57)
`
`ABSTRACT
`
`(76) Inventors: Ulrich R. Haug, Campbell, CA (US);
`Hans F. Valencia, Berkeley, CA (US);
`Robert A. Geshlider, San Francisco,
`CA (US); Torn Saul, El Granada, CA
`(US); Amr Salahieh, Saratoga, CA
`(US); Dwight P. Morejohn, Davis, CA
`(US); Kenneth J. Michlitsch,
`Livermore, CA (US)
`
`Correspondence Address:
`WILSON SONSINI GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304-1050 (US)
`
`(21) Appl. No.:
`
`10/870,340
`
`(22) Filed:
`
`Jun. 16, 2004
`
`Publication Classi?cation
`
`(51) rm.c1.7 ...................................................... ..A61F 2/24
`(52) U.S. c1. ....................... .. 623/211; 623/238; 623/900
`
`The present invention provides methods and apparatus for
`endovascularly replacing a patient’s heart valve. The appa
`ratus includes a replacement valve and an expandable
`anchor con?gured for endovascular delivery to a vicinity of
`the patient’s heart valve. In some embodiments, the replace
`ment valve is adapted to Wrap about the anchor, for example,
`by everting during endovascular deployment. In some
`embodiments, the replacement valve is not connected to
`expandable portions of the anchor. In some embodiments,
`the anchor is con?gured for active foreshortening during
`endovascular deployment. In some embodiments, the anchor
`includes expandable lip and skirt regions for engaging the
`patient’s heart valve during deployment. In some embodi
`ments, the anchor comprises a braid fabricated from a single
`strand of Wire. In some embodiments, the apparatus includes
`a lock con?gured to maintain anchor expansion. The inven
`tion also includes methods for endovascularly replacing a
`patient’s heart valve. In some embodiments, the method
`includes the steps of endovascularly delivering a replace
`ment valve and an expandable anchor to a vicinity of the
`heart valve, Wrapping at least a portion of the replacement
`valve about the anchor, and expanding the anchor to a
`deployed con?guration.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 1 of 78
`
`
`
`
`
`Edwards Lifesciences Corporation, et 31. Exhibit 1135, Pageeee 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 2 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 2 of 63
`
`US 2005/0283231 A1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 3 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 3 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 3 0f 63
`
`US 2005/0283231 A1
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 4 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 4 0f 63
`
`US 2005/0283231 A1
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 5 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 5 0f 63
`
`US 2005/0283231 A1
`
`30
`/0
`100
`K / 50 C”? / (1/0 (60
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 6 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 6 0f 63
`
`US 2005/0283231 A1
`
`/00
`
`“Hi
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 7 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 7 0f 63
`
`US 2005/0283231 A1
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 8 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 8 0f 63
`
`US 2005/0283231 A1
`
`FIG: 5B
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 9 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 9 0f 63
`
`US 2005/0283231 A1
`
`FIG 50
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 10 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 10 0f 63
`
`US 2005/0283231 A1
`
`//0
`
`I00
`
`_
`
`L,
`
`/‘ //Z
`
`'
`
`A
`.50
`
`' "50
`
`/
`
`FIG‘. '50
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 11 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 11 0f 63
`
`US 2005/0283231 A1
`
`F/GI 5E
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 12 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 12 0f 63
`
`US 2005/0283231 A1
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 13 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 13 0f 63
`
`US 2005/0283231 A1
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 14 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 14 0f 63
`
`US 2005/0283231 A1
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 15 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 15 0f 63
`
`US 2005/0283231 A1
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 16 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 16 0f 63
`
`US 2005/0283231 A1
`
`F761 60
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 17 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 17 0f 63
`
`US 2005/0283231 A1
`
`Q\\\\\\\\\\\\\\\\ \ \ \. \ \ \
`
`|\~ Y
`
`FIG 65
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 18 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 18 0f 63
`
`US 2005/0283231 A1
`
`F/GZ 6F I
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 19 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 19 0f 63
`
`US 2005/0283231 A1
`
`//
`
`f _
`.
`1 A /
`1
`/
`
`n
`
`I
`/20 //
`L /
`v
`
`A
`
`r
`
`,
`
`I
`.
`5
`i~...dp~“
`f
`a
`
`.
`
`.
`
`..
`
`'
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 20 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 20 of 63
`
`US 2005/0283231 A1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 21 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 21 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 21 of 63
`
`US 2005/0283231 A1
`
`
`
`FIG 86‘
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 22 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 22 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 22 of 63
`
`US 2005/0283231 A1
`
`
`
`Fla 9/!
`
`.
`
`FIG: 95
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 23 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 23 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 23 of 63
`
`US 2005/0283231 A1
`
`- A30) //00"
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 24 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 24 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 24 of 63
`
`US 2005/0283231 A1
`
`
`
`F763 //6‘
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 25 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 25 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 25 of 63
`
`US 2005/0283231 A1
`
`
`
`FIG /2A
`
`
`
`FIG? IZC
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 26 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 26 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 26 of 63
`
`US 2005/0283231 A1
`
`
`
`FIG? /5C
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 27 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 27 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 27 of 63
`
`US 2005/0283231 A1
`
`
`
`FIG.» ISA
`
`A *4
`
`2'04
`
`'
`
`o
`
`
`
`204
`
`200
`‘
`
`I
`
`1/1
`‘\ '1‘200 '
`\J
`.
`.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 28 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 28 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 28 of 63
`
`US 2005/0283231 A1
`
`3/48 ‘
`
`3/2
`
`8.0406mawmm
`
`;g%s.¢;nxxxxxxaaaw
`.\
`
`qmwooomovmoohog;
`oo..o.ooooo..oo.o.
`o..o.oooo.o¢o.oo.o
`.exzzxxxxxxxxxquv
`.o....ooo.o.ooooo.
`o.o...o.oo.o.o.ooo
`§2a§axxxaaxzxayaxw
`3%323233322333332w_
`
`
`4‘94oddofiéfcdiflod..
`maxaaxammmwwmmmwmwmm
`.o.oooooooo..o.oo
`‘‘“‘4‘‘{‘1‘1‘i‘1
`
`.exaaaaayyaxnxxnnw
`.o..o.o..o.ooo.o.
`oo...o.¢..o.....o
`o¢o.o¢o.oooooo¢.o,
`
`Ap”
`
`gpxxpxxaznnpnnnxxw
`.22223232222222223
`
`.......o.o.ooo....
`
`304'
`
`
`
`* ---
`
`.
`
`%
`-.
`‘-
`
`.
`..
`
`
`AImanufiucon00005
`:22z..3&...........
`£252?
`..5.........................
`.ggggg
`.*.>.gg.3.:.
`...................s..._
`gggggzs
`.......................?
`...........
`
`.-‘-
`$.
`
`.-
`G.
`«o»
`‘.
`---
`..
`
`.—-
`‘>
`
`----
`
`- -.<
`‘ -
`
`.-
`.>
`‘.
`
`atg§.$s2.
`
`.éggggé.$.zr?s.
`ggg§2§
`agggggs
`:szzgz.
`§§zgggg
`:ségsz
`z...5....
`
`
`
`2m.
`
`FIG? IBA'
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 29 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 29 of 78
`
`
`
`
`
`
`
`
`
`
`Patent Application Publication Dec. 22, 2005
`
`Sheet 29 of 63
`
`US 2005/0283231 A1
`
`3/48
`
`3/0 308
`
`«.«.«.«.«.u.«.«.«.«.......A
`*imvuowow..w{ufi,9.9
`
`‘.....4...
`B...............
`,.om.«.«.%§4owwwow.w.w.d.9...........
`
`.’.§
`......................
`mwmouwm.w.».n.»..$9»...
`«Max{4.43>4I4b40¢O<QQ
`
`..................
`9...u.
`a...»....«.«.«...........
`............
`..........«..»
`000990
`
`3
`
`5....
`
`D}
`
`DOG,
`
`.,. '-
`
`..........
`
`.‘
`
`90
`
`..Dog
`
`
`
`FIG: /78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 30 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 30 of 78
`
`
`
`‘333‘3‘3‘3‘3‘3‘3‘3‘3‘3‘3‘3‘3‘:
`0W¢o’¢‘o’o%%‘o’o’o‘o’
`’o’o’o’oVo’o‘o‘o’fl‘o’fio‘o‘o'
`a? mmmnmm
`9‘ “‘9m h
`_OW’3’6'W'W
`«a.:o:¢.:.:»:om:¢ozo:o
`’9W9WWII!0’
`
`#
`
`M AW’MWWo’I
`
`_ l A
`
`I
`
`A
`
`A
`
`l A
`
`A
`
`L L A
`
`A 1H
`
`
`
`‘
`
`FlaI88-
`
`'
`
`_
`
`“
`
`0 %
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 31 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 31 of 63
`
`US 2005/0283231 A1
`
`.30
`
`
`
`VIIIIIIIIIIJ’IIIIIIII'I'I'IIIIA
`
`
` ‘VL““““““““‘““““‘V V
`
`
`62'
`
`a
`F/6? l9
`
`
`
`
`
`
`71””1WIIIIIIIIIHHHHIIIIA
`
`A“L‘K‘K“““““““\“““V
`
`62
`
`Fl6? 20
`
`: S30 63 r
`
`I
` £60h.““““‘““““““
`
`
`
`62
`
`FIG. 2/
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 32 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 32 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 32 of 63
`
`US 2005/0283231 A1
`
`&
`
`.Q'
`
`4;
`
`#9,
`
`g
`5%.
`
` ‘1‘
`
`N #
`
`8
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 33 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 33 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 33 of 63
`
`US 2005/0283231 A1
`
`FIG?23_
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 34 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 34 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005
`
`Sheet 34 of 63
`
`US 2005/0283231 A1
`
`.VN6Q
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 35 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 35 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 35 of 63
`
`US 2005/0283231 A1
`
`\
`
`.
`
`FIG?25'
`
`i
`
`_
`
`‘
`
`‘9
`MN
`MW
`WW
`WNW I
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 36 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 36 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 36 of 63
`
`US 2005/0283231 A1
`
` .560.
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 37 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 37 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 37 of 63
`
`US 2005/0283231 A1
`
`«.
`
`-
`
`
`
`\ /, \ A4 .\‘
`7.
`/
`
`§.'r\,.
`
`’I.
`
`.4'25‘?/\'O
`No.
`3&9”. ‘Q/“f’I/Q ‘
`
`
`
`A
`
`‘~
`
`’ ,.\
`,
`
`
`
`can ‘ /
`,
`
`/A
`
`x“;
`\/
`
`370
`
`FIG? 27
`
`376.
`
`372
`
`.
`
`@ 374
`3705
`
`FIG: 29
`
`372
`
`
`
`K370
`
`FIG. .3/
`
`'37s 1
`
`
`
`0 374
`
`372 p
`
`F[6? 30
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 38 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 38 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 38 of 63
`
`US 2005/0283231 A1
`
`380
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 39 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 39 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 39 of 63
`
`US 2005/0283231 A1
`
`
`
`FIG. 35B
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 40 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 40 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 40 of 63
`
`US 2005/0283231 A1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 41 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 41 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 41 of 63
`
`US 2005/0283231 A1
`
`
`
`‘F/G? 35F
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 42 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 42 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 42 of 63
`
`US 2005/0283231 A1
`
`FIG. 35.6
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 43 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 43 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 43 of 63
`
`US 2005/0283231 A1
`
`4760
`
`4762? '
`
`4766‘
`
`474
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 44 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 44 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 44 of 63
`
`US 2005/0283231 A1
`
`
`
`FIG 36C
`
`x450
`
`483
`
`482
`4‘80
`
`\ .
`484
`
`A
`
`F/GI 36E
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 45 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 45 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 45 of 63
`
`US 2005/0283231 A1
`
`FIG:37/!
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 46 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 46 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 46 of 63
`
`US 2005/0283231 A1
`
`375
`
`g
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 47 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 47 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005
`
`Sheet 47 0f 63
`
`US 2005/0283231 A1
`
`
`
`F/GI 38A
`
`Edwa
`
`rds Lifesciences
`
`C0
`
`rporatio
`
`11, et a]. Exhibit 1135, Page 48 0f 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 48 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005
`
`Sheet 48 of 63
`
`US 2005/0283231 A1
`
`
`
`[7/62, 383
`
`Edwa
`
`rds Lifesciences
`
`Corporation, et a]. Exhibit 1135, Page 49 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 49 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005
`
`Sheet 49 0f 63
`
`US 2005/0283231 A1
`
`
`
`1‘76: 386
`
`Edwa
`
`rds Lifesciences Corporatio
`
`11, et a]. Exhibit 1135, Page 50 0f 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 50 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 50 of 63
`
`US 2005/0283231 A1
`
`
`
`FIE. 39/!
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 51 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 51 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 51 of 63
`
`US 2005/0283231 A1
`
`
`
`FIG. 39C
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 52 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 52 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 52 of 63
`
`US 2005/0283231 A1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 53 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 53 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 53 of 63
`
`US 2005/0283231 A1
`
`
`
`FIG. 39.6
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 54 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 54 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 54 of 63
`
`US 2005/0283231 A1
`
`
`
`360
`
`FIG. 40/)
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 55 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 55 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 55 of 63
`
`US 2005/0283231 A1
`
`//2’
`
`//0’
`
`, /
`
`360
`
`FIG. 405
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 56 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 56 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 56 of 63
`
`US 2005/0283231 A1
`
`
`
`F/G. 406‘
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 57 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 57 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 57 0f 63
`
`US 2005/0283231 A1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 58 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 58 0f 63
`
`US 2005/0283231 A1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 59 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 59 of 63
`
`US 2005/0283231 A1
`
`//2’
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 60 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 60 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 60 of 63
`
`US 2005/0283231 A1
`
`//2'
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 61 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 61 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 61 of 63
`
`US 2005/0283231 A1
`
`#2 ’
`
`/ 700'
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 62 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 62 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 62 of 63
`
`US 2005/0283231 Al
`
`I
`
`,
`
`_
`
`.550
`
`50
`
`'
`
`,
`
`V
`
`i
`f I
`'
`
`a
`
`840
`
`I
`
`822
`826
`7828
`-
`
`) 826
`
`826
`
`5’20
`
`\
`‘
`
`g ,
`
`.
`:
`
`t
`2
`
`
`
`‘
`
`
`l
`
`800‘
`
`/
`
`830
`
`828‘
`
`I.
`
`I
`I
`
`,
`
`-
`
`I
`
`-
`
`.
`O
`.
`.
`.
`I
`.
`
`i
`
`'
`
`.
`
`x
`
`‘
`i
`"
`
`l
`
`.
`
`I'u'o-ccoouno
`
`-
`t
`
`9
`a
`I
`
`830
`
`I'
`
`550
`
`_ 800
`
`l
`
`
`
`823
`
`U’IOOOIOGOOI
`
`
`
`1-73 428
`
`828
`
`FIG 42/!
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 63 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 63 of 78
`
`
`
`Patent Application Publication Dec. 22, 2005 Sheet 63 of 63
`
`US 2005/0283231 A1
`
`
`
`l028 F/GI 44A
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 64 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 64 of 78
`
`
`
`US 2005/0283231 A1
`
`Dec. 22, 2005
`
`EVERTING HEART VALVE
`
`BACKGROUND OF THE INVENTION
`
`[0001] The present invention relates to methods and appa-
`ratus for endovascularly replacing a heart valve. More
`particularly, the present invention relates to methods and
`apparatus for endovascularly replacing a heart valve with a
`replacement valve and an expandable and retrievable
`anchor. The replacement valve preferably is not connected to
`the expandable anchor and may be wrapped about an end of
`the anchor, for example, by everting during endovascular
`deployment.
`
`[0002] Heart valve surgery is used to repair or replace
`diseased heart valves. Valve surgery is an open-heart pro-
`cedure conducted under general anesthesia. An incision is
`made through the patient’s sternum (sternotomy), and the
`patient’s heart
`is stopped while blood flow is rerouted
`through a heart-lung bypass machine.
`
`[0003] Valve replacement may be indicated when there is
`a narrowing of the native heart valve, commonly referred to
`as stenosis, or when the native valve leaks or regurgitates.
`When replacing the valve, the native valve is excised and
`replaced with either a biologic or a mechanical valve.
`Mechanical valves require lifelong anticoagulant medication
`to prevent blood clot formation, and clicking of the valve
`often may be heard through the chest. Biologic tissue valves
`typically do not require such medication. Tissue valves may
`be obtained from cadavers or may be porcine or bovine, and
`are commonly attached to synthetic rings that are secured to
`the patient’s heart.
`
`[0004] Valve replacement surgery is a highly invasive
`operation with significant concomitant risk. Risks include
`bleeding, infection, stroke, heart attack, arrhythmia, renal
`failure, adverse reactions to the anesthesia medications, as
`well as sudden death. 2-5% of patients die during surgery.
`
`[0005] Post-surgery, patients temporarily may be confused
`due to emboli and other factors associated with the heart-
`
`lung machine. The first 2-3 days following surgery are spent
`in an intensive care unit where heart functions can be closely
`monitored. The average hospital stay is between 1 to 2
`weeks, with several more weeks to months required for
`complete recovery.
`
`In recent years, advancements in minimally inva-
`[0006]
`sive surgery and interventional cardiology have encouraged
`some investigators to pursue percutaneous replacement of
`the aortic heart valve. See, e.g., US. Pat. No. 6,168,614. In
`many of these procedures, the replacement valve is deployed
`across the native diseased valve to permanently hold the
`valve open, thereby alleviating a need to excise the native
`valve and to position the replacement valve in place of the
`native valve.
`
`In the endovascular aortic valve replacement pro-
`[0007]
`cedure, accurate placement of aortic valves relative to coro-
`nary ostia and the mitral valve is critical. Standard self-
`expanding systems have very poor accuracy in deployment,
`however. Often the proximal end of the stent is not released
`from the delivery system until accurate placement is verified
`by fluoroscopy, and the stent typically jumps once released.
`It is therefore often impossible to know where the ends of
`the stent will be with respect
`to the native valve,
`the
`coronary ostia and the mitral valve.
`
`[0008] Also, visualization of the way the new valve is
`functioning prior to final deployment
`is very desirable.
`Visualization prior to final and irreversible deployment
`cannot be done with standard self-expanding systems, how-
`ever, and the replacement valve is often not fully functional
`before final deployment.
`
`[0009] Another drawback of prior art self-expanding
`replacement heart valve systems is their lack of radial
`strength. In order for self-expanding systems to be easily
`delivered through a delivery sheath, the metal needs to flex
`and bend inside the delivery catheter without being plasti-
`cally deformed. In arterial stents, this is not a challenge, and
`there are many commercial arterial stent systems that apply
`adequate radial force against the vessel wall and yet can
`collapse to a small enough of a diameter to fit inside a
`delivery catheter without plastic deformation. However
`when the stent has a valve fastened inside it, as is the case
`in aortic valve replacement, the anchoring of the stent to
`vessel walls is significantly challenged during diastole. The
`force to hold back arterial pressure and prevent blood from
`going back inside the ventricle during diastole will be
`directly transferred to the stent/vessel wall interface. There-
`fore, the amount of radial force required to keep the self-
`expanding stent/valve in contact with the vessel wall and not
`sliding will be much higher than in stents that do not have
`valves inside of them. Moreover, a self-expanding stent
`without sufficient radial force will end up dilating and
`contracting with each heartbeat, thereby distorting the valve,
`affecting its function and possibly migrating and dislodging
`completely. Simply increasing strut thickness of the self-
`expanding stent is not a practical solution as it runs the risk
`of larger profile and/or plastic deformation of the self-
`expanding stent.
`
`In view of drawbacks associated with previously
`[0010]
`known techniques for endovascularly replacing a heart
`valve, it would be desirable to provide methods and appa-
`ratus that overcome those drawbacks.
`
`SUMMARY OF THE INVENTION
`
`[0011] One aspect of the present invention provides appa-
`ratus for endovascularly replacing a patient’s heart valve, the
`apparatus including: a replacement valve; and an expandable
`anchor, wherein the replacement valve and expandable
`anchor are configured for endovascular delivery to the
`vicinity of the heart valve, and wherein at least a portion of
`the replacement valve is configured to evert about the anchor
`during endovascular deployment.
`
`[0012] Another aspect of the invention provides a method
`for endovascularly replacing a patient’s heart valve. In some
`embodiments the method includes the steps of: endovascu-
`larly delivering a replacement valve and an expandable
`anchor to a vicinity of the heart valve; everting at least a
`portion of the replacement valve about
`the anchor; and
`expanding the anchor to a deployed configuration.
`
`[0013] Yet another aspect of the invention provides appa-
`ratus for endovascularly replacing a patient’s heart valve
`including: an anchor comprising a lip region and a skirt
`region; and a replacement valve, wherein at least a portion
`of the replacement valve is configured to evert about the
`anchor during endovascular deployment, and wherein the lip
`region and skirt region are configured for percutaneous
`expansion to engage the patient’s heart valve.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 65 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 65 of 78
`
`
`
`US 2005/0283231 A1
`
`Dec. 22, 2005
`
`[0014] Still another aspect of the present invention pro-
`vides a method for endovascularly replacing a patient’s heart
`valve,
`the method including: endovascularly delivering a
`replacement valve and an expandable anchor to a vicinity of
`the heart valve, endovascularly wrapping at least a portion
`of the replacement valve about the anchor, and expanding
`the anchor to a deployed configuration.
`
`[0015] Another aspect of the present invention provides
`apparatus for endovascularly replacing a patient’s heart
`valve, the apparatus including: a replacement valve, and an
`expandable anchor, wherein the replacement valve and the
`anchor are configured for endovascular delivery to a vicinity
`of the patient’s heart valve, and wherein at least a portion of
`the replacement valve is wrapped about an end of the anchor
`in a deployed configuration.
`
`INCORPORATION BY REFERENCE
`
`[0016] All publications and patent applications mentioned
`in this specification are herein incorporated by reference to
`the same extent as if each individual publication or patent
`application was specifically and individually indicated to be
`incorporated by reference.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0017] The novel features of the invention are set forth
`with particularity in the appended claims. A better under-
`standing of the features and advantages of the present
`invention will be obtained by reference to the following
`detailed description that sets forth illustrative embodiments,
`in which the principles of the invention are utilized, and the
`accompanying drawings of which:
`
`[0018] FIGS. 1A-B are elevational views of a replacement
`heart valve and anchor according to one embodiment of the
`invention.
`
`[0019] FIGS. 2A-B are sectional views of the anchor and
`valve of FIG. 1.
`
`[0020] FIGS. 3A-B show delivery and deployment of a
`replacement heart valve and anchor, such as the anchor and
`valve of FIGS. 1 and 2.
`
`[0021] FIGS. 4A-F also show delivery and deployment of
`a replacement heart valve and anchor, such as the anchor and
`valve of FIGS. 1 and 2.
`
`[0022] FIGS. 5A-F show the use of a replacement heart
`valve and anchor to replace an aortic valve.
`
`[0023] FIGS. 6A-F show the use of a replacement heart
`valve and anchor with a positive registration feature to
`replace an aortic valve.
`
`[0024] FIG. 7 shows the use of a replacement heart valve
`and anchor with an alternative positive registration feature to
`replace an aortic valve.
`
`[0025] FIGS. 8A-C show another embodiment of a
`replacement heart valve and anchor according to the inven-
`tion.
`
`[0026] FIGS. 9A-H show delivery and deployment of the
`replacement heart valve and anchor of FIG. 8.
`
`[0028] FIGS. 11A-C show alternative locks for use with
`replacement heart valves and anchors of this invention.
`
`[0029] FIGS. 12A-C show a vessel wall engaging lock for
`use with replacement heart valves and anchors of this
`invention.
`
`[0030] FIG. 13 demonstrates paravalvular leaking around
`a replacement heart valve and anchor.
`
`[0031] FIG. 14 shows a seal for use with a replacement
`heart valve and anchor of this invention.
`
`[0032] FIGS. 15A-E show alternative arrangements of
`seals on a replacement heart valve and anchor.
`
`[0033] FIGS. 16A-C show alternative seal designs for use
`with replacement heart valves and anchors.
`
`[0034] FIG. 17 show an alternative anchor lock embodi-
`ment in an unlocked configuration.
`
`[0035] FIGS. 18A-B show the anchor lock of FIG. 17 in
`a locked configuration.
`
`[0036] FIG. 19 shows an alternative anchor deployment
`tool attachment and release mechanism for use with the
`invention.
`
`[0037] FIG. 20 shows the attachment and release mecha-
`nism of FIG. 19 in the process of being released.
`
`[0038] FIG. 21 shows the attachment and release mecha-
`nism of FIGS. 19 and 20 in a released condition.
`
`[0039] FIG. 22 shows an alternative embodiment of a
`replacement heart valve and anchor and a deployment tool
`according to the invention in an undeployed configuration.
`
`[0040] FIG. 23 shows the replacement heart valve and
`anchor of FIG. 22 in a partially deployed configuration.
`
`[0041] FIG. 24 shows the replacement heart valve and
`anchor of FIGS. 22 and 23 in a more fully deployed
`configuration but with the deployment tool still attached.
`
`[0042] FIG. 25 shows yet another embodiment of the
`delivery and deployment apparatus of the invention in use
`with a replacement heart valve and anchor.
`
`[0043] FIG. 26 shows the delivery and deployment appa-
`ratus of FIG. 25 in the process of deploying a replacement
`heart valve and anchor.
`
`[0044] FIG. 27 shows an embodiment of the invention
`employing seals at the interface of the replacement heart
`valve and anchor and the patient’s tissue.
`
`[0045] FIG. 28 is a longitudinal cross-sectional view of
`the seal shown in FIG. 27 in compressed form.
`
`[0046] FIG. 29 is a transverse cross-sectional view of the
`seal shown in FIG. 28.
`
`[0047] FIG. 30 is a longitudinal cross-sectional view of
`the seal shown in FIG. 27 in expanded form.
`
`[0048] FIG. 31 is a transverse cross-sectional view of the
`seal shown in FIG. 30.
`
`[0027] FIG. 10 is a cross-sectional drawing of the delivery
`system used with the method and apparatus of FIGS. 8 and
`9.
`
`[0049] FIG. 32 shows yet another embodiment of the
`replacement heart valve and anchor of this invention in an
`undeployed configuration.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 66 of 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1135, Page 66 of 78
`
`
`
`US 2005/0283231 A1
`
`Dec. 22, 2005
`
`[0050] FIG. 33 shows the replacement heart valve and
`anchor of FIG. 32 in a deployed configuration.
`
`[0051] FIG. 34 shows the replacement heart valve and
`anchor of FIGS. 32 and 33 deployed in a patient’s heart
`valve.
`
`[0052] FIGS. 35A-H show yet another embodiment of a
`replacement heart valve, anchor and deployment system
`according to this invention.
`
`[0053] FIGS. 36A-E show more detail of the anchor of the
`embodiment shown in FIGS. 35A-H.
`
`[0054] FIGS. 37A-B show other embodiments of the
`replacement heart valve and anchor of the invention.
`
`[0055] FIGS. 38A-C illustrate a method for endovascu-
`larly replacing a patient’s diseased heart valve.
`
`[0056] FIGS. 39A-G are side views, partially in section, as
`well as an isometric view, illustrating a method for endo-
`vascularly replacing a patient’s diseased heart valve with an
`embodiment of the present invention comprising a replace-
`ment valve that is not connected to the expandable anchor,
`the replacement valve wrapped about the anchor, illustra-
`tively by everting during deployment.
`
`[0057] FIGS. 40A-D are side views, partially in section,
`illustrating a method for endovascularly replacing a patient’s
`diseased heart valve with another everting embodiment of
`the present invention.
`
`[0058] FIGS. 41A-E are side views, partially in section,
`illustrating a method for endovascularly replacing a patient’s
`diseased heart valve with yet another everting embodiment
`of the present invention, wherein the replacement valve and
`the anchor are telescoped relative to one another during
`endovascular delivery.
`
`[0059] FIGS. 42A-B are side-sectional views of alterna-
`tive everting apparatus comprising everting valve leaflets.
`
`[0060] FIGS. 43A-B, are side-sectional views of further
`alternative everting apparatus comprising a locking mecha-
`nism coupled to the everting segment.
`
`[0061] FIGS. 44A-B are side-sectional views of telescop-
`ing embodiments of the present
`invention comprising
`U-shaped valve frames.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`[0062] While preferred embodiments of the present inven-
`tion have been shown and described herein,
`it will be
`obvious to those skilled in the art that such embodiments are
`
`provided by way of example only. Numerous variations,
`changes, and substitutions will now occur to those skilled in
`the art without departing from the invention. It should be
`understood that various alternatives to the embodiments of
`
`th