Hilllillllliltill11111111!ilillillillllliliilllll11111111111111
`[1800791456932
`
`US 7,914,569 B2
`(10) Patent No;
`(12) United States Patent
`Nguyen et a1.
`(45) Date of Patent:
`Mar. 29, 2011
`
`
`(75)
`
`(54) HEART VALVE PROSTHESIS AND METHODS
`q‘
`7
`t
`‘
`‘
`’
`‘
`OI MANUFACIURE AND USE
`.
`.
`I,
`Inventors: Than Nguyen, Placental, CA (U:S);
`Hung Nguyen, Garden (Hove. CA (us);
`Mykim Nguyen, Santa Ana, CA (US);
`Stanley Komatsu, Laguna Hills, CA
`(US); Robrecht Michlels, Laguna Hills,
`CA (US)
`
`3,671,979 A
`3,714,671 A
`3,755,823 A
`3,795,246 A
`3.839,741 A
`3,868,956 A
`3,874,388 A
`4935349 A
`4955354 A
`
`6/1972 Moutopoutos
`11973 Edwards ct n1.
`9/1973 Hancock
`3/1974 St
`10/1974 H3130“
`311975 Atfidi et a1.
`£1975 King ct al.
`71:1972 M80“ C131-
`1" 197' 13mm 6‘ 2“-
`(Continued)
`
`(73) Assignee: Mcdtronics CoreValve LLC,
`Minneapolis, MN (US)
`
`CN
`
`FOREIGN PATENT DOCUMENTS
`101011298 A
`72007
`
`( "‘ ) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 1540)) by 282 days.
`
`(21) App]. N0: 11/128,826
`.
`Flled:
`
`(22)
`
`May 13, 2005
`‘
`Prior Publication Data
`US 2006/0259136 A1
`Nov. 16, 2006
`
`(65)
`
`(5])
`
`1m. C].
`(2006.01)
`A61F 2/24
`(52) US. Cl.
`..................... 623/118: 623/212; 623/217;
`.
`623/900
`(58) Field of Classification Search ................. 623/1 .24,
`62311.26, 2.12-2.19, 2.33, 2.36, 2.38, 2.42.
`623/900
`See application file for complete search history.
`
`(56)
`
`RGfEI‘CHCCS Cited
`‘ V
`_
`_‘
`’ ,
`‘
`.. ‘
`‘
`1
`U5 RM 5N1 DOLUMBN”
`3,334,629 A
`8/1967 Cohn
`24232;: 2
`“flags 1316?, L‘ ld’
`”.3
`om-tlm
`3,587.1 I 5 A
`6/1971 Shiley
`3,628,535 A
`12,1971 Omowsky et a].
`3,642,004 A
`21972 Osthagen et :11.
`3,657,744 A
`4/1972 Ersek
`
`(Continued)
`,
`,.
`,
`,
`,
`.,
`OleR PUBLILAI lONS
`BallombExpana/yle lntmcomnaty Stem in the Adult Dog; Schatz.
`Richard MD ctal.;Laborazorylimestigati011~llr0tomrdial[so/29min,
`pp. 450—457 (1987).
`
`(Continued)
`
`Printer}! Examuzer ~ DaVld Isabella
`Assmam Exammer —— Suba Ganesan
`
`(74) Attorney. Agent, or Firm —— William L. Haynes; Mike
`18f0
`
`ABSTRACT
`(57)
`A heart valve prosthesis is provided having a self—expanding
`multi—level frame that supports a valve body comprising 21
`skirt and plurality ofcoapting leaflets. The frame transitions
`between a contracted delivery configuration that enables per-
`cutaneous translunlinal delivery, and an expanded deployed
`configuration having an asymmetric hourglass shape. The
`valve body skirt and leaflets are constructed so that the center
`of coaptation may be selected to reduce horizontal forces
`applied to the commissures of the valve, and to efficiently
`distribute and transmit forces along the leaflets and to the
`.1
`.'
`.
`.
`.
`-_
`frame. Alternatively, the valve body may be used as a surgl
`cally implantable replacement valve prosthesm.
`18 Claims, 4 Drawing Sheets
`
`
`
`

`

`US 7,914,569 B2
`
`Page2
`
`623/216
`
`-
`U.S. PATENT DOCUMENTS
`4,106,129 A
`8/1978 CaJpentleretal.
`4,222,126 A
`9/1980 Bo1:etosetal.
`41233590 A
`“I 1980 Ah“
`44265594 A
`“981 13mm
`439L420 A
`9/1981 Re“!
`4,297,749 A
`11/1981 Dav1seta1.
`4 39 831
`/ 982 J hn
`'3
`1
`A
`71
`°
`5°“
`4,340,977 A
`7/1982 Brownlee el al.
`4,343,048 A
`8/1982 Rossetal.
`4 45340 A
`8/ 982 R
`’3
`~
`1
`95°"
`44125908 A
`“1984 5""0"
`“470-157 A
`9/ ‘984 L°Ve
`4,501,030 A
`2/1985 Lane ............................ 623/218
`4574303 A
`3/1936 3‘9”
`41580-563 A
`“985 5mm”
`4597-1340 A
`“1985 3.0)“? .
`4,610,688 A
`9/1986 S1lvestnn1etal.
`416110” A
`9’19““ “1"ka
`4,647,283 A
`3/1987 Cament1eretal.
`4,648,881 A
`3/1987 Caxpentleretal.
`45551771 A
`“987 WA‘FS‘E“
`4,662,885 A
`5/1987 l)1P1_s:1,Jr.
`44665906 A
`M987 Jam“ .
`4,681,908 A
`7/1987 Bfodenckel :11.
`4’71“” A W193” WIMAF‘AI-
`47331665 A
`”988 PAW“
`4,777,951 A
`10/l988 Cnbler e121].
`4,787,899 A
`11/1988 Lazarus
`jggggg,‘ A
`“$1933 23”“,
`2
`-
`J A
`”9
`‘f‘Yze
`4,819,751 A
`4/1989 Shunadactal.
`4,834,755 A
`5/1989 s11vosmni c161.
`44856-516 A
`“989 “”15“?“
`4,872,874 A
`10/1989 Tahcn
`4,878,495 A
`11/1989 Grayzcl
`4,878,906 A
`11/1989 Lindcmannctal.
`4381458 A
`“$1989 Sh‘lbdfe
`49091252 A
`31990 G‘?
`”5‘“
`4,917,102 A
`4/1990 M1lleret al.
`41922905 A
`5;”90 sujlck”
`41954126 A
`9/199" W“. 5‘“
`49561504 A
`101990 Re!“
`4,979,939 A
`12/1990 Shlber
`4,986,830 A
`1/1991 Owensetal.
`4'994'077 A
`2A9” D°bben
`Eggs: A
`3/1331 31:“
`’
`‘
`4/1
`1
`‘ er
`24325355 A
`5/1991 Diem“
`* 32-128 A
`71991 A°ns°
`5,037,434 A
`8/1991 Lane ............................ 623/218
`5,047,041 A
`9/1991 Samuels
`510591177 A
`“31991 “WEB 9‘ 111-
`2183:1357? A
`12,133; 2”
`.
`'3 A
`”13%
`.
`51089915 A
`”1992 R°55
`5,152,771 A
`10/1992 Sabbaghmn e161.
`“51547 A
`1“ 1992 TN”
`51163953 A
`131992 ““91"
`21%“ng A
`151/1992 303’“
`' ”Am A
`1993 “we“
`5,232,445 A
`8/1993 Bonzel
`5,272,909 A
`12/1993 Nguyen etal,
`51335958 A
`“994 51“““3‘3’3
`1
`513~71774 A
`7’1994 NEW“ ”‘3'
`5,332,402 A
`7/1994
`lellelhmlm
`5,350,398 A
`9/1994 ancnik el al.
`2328382 A
`'31??? SEEMS
`-’
`*0
`’ ”-
`”er.
`5,397,351 A
`3/1995 Pavcmkel :11.
`5,411,552 A
`5/1995 Anderscnelal.
`5,415,633 A
`5/1995 Lammsetal.
`5,431,676 A
`7/1995 Dubrul e161.
`5,443,446 A
`8/1995 Shturmzm
`5,480,424 A
`1/1996 Cox
`5,489,294 A
`2/1996 Mchncsctal.
`5,489,297 A
`2/1996 Duran
`5,496,346 A
`3/1996 Homewski et 211.
`
`n
`,
`gézflgg’; A
`5 54:21, A
`5:545:214 A
`5,554,185 A
`5 575,818 A
`5,580,922 A
`5,591,195 A
`5,609,626 A
`5,645,559 A
`
`5,665,115 A
`5,667,523 A
`5,674,277 A
`5,695,498 A
`5302368 A
`5,713,953 A
`5,716,417 A
`5,746,709 A
`5749 890 A
`5,766,151 A
`5782809 A
`$800,456 A
`5,800,508 A
`5817126 A
`5,824,041 A
`5824043 A
`5,824,053 A
`5,824,056 A
`5824061 A
`5824064 A
`5,840,081 A
`5,843,158 A
`5851232 A
`5'855'597 A
`5,855,601 A
`5860 966 A
`5‘861’028 A
`5'868'783 A
`5,876,448 A
`5,888,201 A
`5891191 A
`5,906,619 A
`5,907,893 A
`5,913,842 A
`5925 063 A
`5‘944'738 A
`5,954,766 A
`5,957,949 A
`5,968,068 A
`5,984,957 A
`5,997,573 A
`6022 370 A
`6,027:525 A
`6,029,671 A
`6,042,589 A
`6,042,598 A
`6,042,607 A
`605,014 A
`6,059,809 A
`6,110,201 A
`6,146,366 A
`6,159,239 A
`6162208 A
`6,162,245 A
`6,168,614 B1
`6,171,335 131
`6200 336 B1
`6'203’550 B1
`6,210,408 B1
`6,218,662 131
`6221091 Bl
`612412757 131
`6-245410 Bl
`-
`,
`2
`6,248,116 Bl
`6,258,114 B1
`6.258.115 Bl
`6,258,120 B1
`6,277,555 B1
`
`.
`
`l
`31932 3:181:13 etal.l
`8/1396 A363? A
`8/1996 Stevens.
`9/1996 Blocket 3.1.
`11/1996 Pinchuk
`12/1996 Park etal.
`.
`1/1997 Tahen et a1.
`3/1997 Quijano etal.
`7/1997 Hachtman etal.
`
`9/1997 Cragg
`9/1997 Bynonetal.
`10/1997 Freitag
`12/1997 Tower
`12,1997 Stevensetal.
`2/1998 Vallanaetal.
`2/1998 Giraxdetal.
`5/1998 Rom e161.
`5/1998 Shaknovich
`6/1998 Valley e161.
`7/1998 Umeno etal.
`9/1998 Maedaelal.
`9/1998 Goicoecheael n1.
`[0/1998 lmran
`10/1998 Lenker
`10/1998 Cottone Jr.
`10/1998 Khosravietal.
`10/1998 Rosenberg
`10/1998 Quijano ctal
`'
`10,1998 Taheri
`11/1998 Andersen c1 :11.
`12/1998 Lcnkcrctal.‘
`12/1998 Lois
`“1999 lawman
`1/1999 Bessleretal.
`“1999 Tower
`“1999 Ange“
`2,1999 Tower
`3/1999 Thompson et a1.
`3/1999 Stinsonetal.
`4,1999 Skim“
`5/1999 Olson etal.
`6/1999 Zadno-Azizietal.
`6/1999 Boydetal.
`7,1999 Khomvi
`8,1999 Amplalzetal.
`9/1999 Zadno-Azizi et 81.
`9/1999 Leonhardl eta].
`10/1999 Dehdashtizm et al.
`11/1999 Laptewicz, Jr. et a1.
`1211999 Quijano et a1.
`“000 Tower
`2/2000 Suh et 81.
`2/2000 Stevens et a1.
`3/2000 Mananne
`3/2000 Tsugitaetal.
`3/2000 Williamson, 1v
`4,2000 mg
`5/2000 Amorel n1.
`8/2000 Quijano etal.
`11/2000 Schachzu
`12/2000 Greenhalgh
`”/2000 Hipps
`”/2000 Jayamman
`1/2001 Anderscnet 111,
`1/2001 Whealleyel :11.
`3/2001 l’avcnikclal
`'
`3,2001 Olson
`4/2001 Chnndmsekamn e161.
`4/2001 Tchakarovetal.
`4/7001 Kh
`.
`65001 An°5le1
`6/3001 J em
`;
`aymf'imm
`6/2001 Chev1lon
`7/2001 Konyaetal.
`7/2001 Dllbflll
`0.001 McKenzie eta].
`8/2001 Duran e1 n1.
`
`NORRED EXHIBIT 2235 - Page 2
`
`

`

`US 7,914,569 BZ
`Page 3
`
`
`6.302.906 B1
`6.309.382 131
`6.309.417 B1
`6.327.772 131
`6.338.735 B]
`6.348.063 B]
`6.350.277 B1
`6.352.708 B]
`6.371.970 B]
`6.371.983 B1
`6.379.383 Bl
`6.380.457 B1
`6.398.807 B1
`6.409.750 B1
`6.425.916 B1
`6.440.164 Bl
`6.454.799 Bl
`6.458.153 131
`6.461.382 B1
`6.468.303 B]
`6.475.239 Bl
`6.482.228 Bl
`6.488.704 B]
`6.494.909 82
`6.503.272 B2
`6.503.274 B]
`6.508.833 132
`6.527.800 Bl
`6.530.949 B2
`6.530.952 B2
`6.562.031 B2
`6.562.058 B2
`6.562.069 132“
`6.569.196 B]
`6.582.462 B1
`6.585.758 B1
`6.585.766 Bl“
`6.592.546 B]
`6.605.112 B1
`6.613.077 132
`6.622.604 B1
`6.632.243 B1
`6.635.068 B1
`6.652.571 B]
`6.652.578 BZ
`6.663.663 132
`6.669.724 B2
`6.673.089 B]
`6.673.109 B2
`6.676.698 B2
`6.682.558 B2
`6.682.559 132
`6.685.739 132
`6.689.144 132
`6.689.164 B1
`6.692.512 B2
`6.692.513 132
`6.695.878 B2
`6.702.851 Bl
`6.719.789 B2
`6.730.118 B2
`6.730.377 BZ
`6.733.525 1'12
`6.736.846 BZ
`6.752.828 132
`6.758.855 B2
`6.769.434 B2
`6.786.925 B1
`6.790.229 B]
`6.792.979 BZ
`6.797.002 BZ
`6.821.297 B2
`6.830.575 B2
`6.830.584 B1
`6.830.585 B]
`6.846.325 132
`6.866.650 BZ
`6.872.223 B2
`6.875.231 B2
`
`
`
`..... 623/238
`
`10/2001 Goicoecheaet a].
`10/200] Garrison et a].
`10/200] Spenceeta].
`12/200] Zadno-A’zizi et a].
`1/2002 Stevens
`2/2002 Yassouretal.
`2/2002 Kocur
`3/2002 Duran eta].
`4/2002 Khosravi etal.
`4/2002 Lane
`4/2002 l’almaz et a].
`4/2002 Yurek eta].
`6/2002 Chouinard at a].
`6/2002 Hyodoheta].
`7/2002 Garrison et a].
`8/2002 Di Matteo eta].
`9/2002 Schreck
`10/2002 Bailey eta].
`10/2002 (1:10
`10/2002 Amplatz eta].
`11/2002 Campbell eta].
`11/2002 Norred
`12/2002 Connelly eta].
`12/2002 Greenhalgh
`1/2003 Duerig eta].
`1/2003 Howanec eta].
`1/2003 Pavcnik eta].
`3/2003 McGuckln.Jr.ctal.
`3/2003 Konyact a1.
`3/2003 Vesely
`5/2003 Chandrasekaran ct a1.
`5/2003 Seguin eta].
`5/2003 Caietal. ...................... 623/...12
`5/2003 Vasely
`6/2003 Andersen eta].
`7/2003 Chouinard eta].
`7/2003 Huynh eta].
`7/2003 Barbuteta].
`8/2003 Mollctal.
`9/2003 Gilligan eta].
`9/2003 Chouinard eta].
`10/2003 Zadno-Aziziet a1.
`10/2003 Dubruleta].
`11/2003 Whiteetal.
`11/2003 Bailey eta].
`12/2003 Kim eta].
`12/2003 Park eta].
`1/2004 Yassouretal.
`1/2004 Cox
`1/2004 McGuckinJret a1.
`1/2004 Tu eta].
`1/2004 Myers eta].
`2/2004 DiMatteo eta].
`2222004 Gerberding
`2/2004 Seguin
`272004 Jang
`2/2004 Streeteretal.
`2/2004 McGuckin. Jr. et a].
`3/2004 Chinn eta].
`4/2004 Cox
`5/2004 Spenser et a1.
`5/2004 Wang
`5/2004 Yang eta].
`5/2004 (on
`6/2004 '1110rnton
`7/2004 Fulton. III et a].
`[8/2004 Liddicoateta].
`9/2004 Schoon eta].
`9/2004 Beneklouw
`9/2004 Kenya et a1.
`9/2004 Spence
`11/2004 Snyders
`12/2004 Stenzeleta].
`12/2004 Seguin
`12/2004 Artof
`1/2005 Liddicoat
`3/2005 Stevens
`3/2005 Roberts
`4/2005 Anduizaetal.
`
`6.883.522 132
`6.887.266 B2
`6.890.330 B2
`6.893.460 B2
`6.896.690 B1
`6.908.481 B2
`6.913.600 B2
`6.929.653 132
`6.936.066 B2
`6.939.365 B1
`6.951.571 B1
`6.986.742 B2
`6.989.027 B2
`6.989.028 B2
`6.991.649 B2
`7.018.401 BI
`7.018.406 B2
`7.041.128 82
`7.044.966 82
`7.048.014 B2
`7.097.659 132
`7.101.396 B2
`7.105.016 B2
`7.115.141 B2
`7.147.663 B]
`7.153.324 B2
`7.160.319 B2
`7.175.656 132
`7.186.265 B2
`7.195.641 B2
`7.198.646 B2
`7.201.761 B2
`7.201.772 B2
`7.252.682 B2
`7.300.457 82
`7.300.463 B2
`7.316.706 B2
`7.329.278 B2
`7.335.218 B2
`7.338.520 B2
`7.374.571 132
`7.381.218 B2
`7.384.411 B1
`7.429.269 B2
`7.442.204 B2
`7.462.191 B2
`7.470.284 B2
`7.481.838 B2
`7.544.206 B2
`7.556.646 B2
`2001/0001314 A]
`2001/0002445 A1
`2001/0007956 A1
`2001/0010017 A1
`2001/0011189 A1
`2001/0021872 A1
`200110025196 A]
`200110032013 A]
`2001/0039450 A1
`2001/0041928 A1
`2001/0044647 A1
`2001/0049555 A1“
`2002/0010508 A]
`2002/0029014 A]
`2002/0032480 A1
`2002/0032481 A1
`200210035396 A]
`2002/0042650 A]
`2002/0042651 A1
`2002/0052651 A1
`200210058995 A]
`2002/0072789 A1
`2002/0095209 A1
`20030099439 A]
`200210103533 A]
`200220107565 A]
`200210111674 A1
`2002/0123802 A1
`200270133183 A]
`
`32005 Spenceet a1.
`/2005 Williams eta].
`5/2005 Streeter eta].
`5/2005 Spenscreta].
`5/2005 Lambrecht et a].
`/2005 Cribier
`7/2005 Valleyetal.
`8/2005 Streeter
`8/2005 Palmazeta].
`9/2005 Fogartyetal.
`10/2005 Srivastava
`1/2006 Harteta].
`/2006 Allen eta].
`1/2006 Lashinski et a1.
`1/2006 Sievers
`3/2006 Hyodoh eta].
`/2006 Seguinet a].
`./2006 McGuckin.Jr.eta].
`/2006 Svanidxe eta].
`5/2006 Hyodoh et a].
`8/2006 Woolfson eta].
`9/2006 Artofetal.
`/2006 Shuieta].
`10/2006 Menzetal.
`12/2006 Berg eta].
`12/2006 Case at a].
`1/2007 Chouinard eta].
`2/2007 Khairkhahan
`3/2007 Sharkawy ct a].
`7’2007 Palmazetal.
`4/2007 Figulla Ct 31.
`4/2007 Woolfsonctal.
`/2007 Schwarnmcnthaleta].
`8/2007 chuin
`11/2007 Palmaz
`11/2007 Liddicoat
`1/2008 Bloom ct a].
`2/2008 Seguin eta].
`200% Wilsoneta].
`3/2008 Baileyeta].
`5/2008 Pease eta].
`6/2008 Schreck
`6/2008 Condado
`9/2008 Schwammenthaletal.
`10/2008 Schwammenthal et a1.
`12/2008 Spenseretal.
`12/2008 Lambreehtetal.
`1/2009 Carpentier et a].
`6/2009 Cohneta].
`7/2009 Yang et a].
`/2001 Davisonetal.
`1200] Vesely
`7/2001 Leta: et a].
`7/2001 Letac eta].
`8/2001 Draslereta].
`/2001 Bailey
`/200] Chinn et a].
`10/2001 Manon
`11/2001 Pavcnik eta].
`11/2001 Pavcnik eta].
`11/2001 Pinchuk eta].
`12/2001 Gabbay ........................ 62312.13
`1/2002 Chobotov
`./2002 Jayaraman
`3/2002 Spence eta].
`3/2002 Gabbay
`/2002 Heath
`/2002 Vardieta].
`/2002 Liddicoateta].
`5/2002 Myers etal.
`5/2002 Stevens
`/2002 Hacked eta].
`7/2002 Zadno-Azizietal.
`7/2002 Schwartz eta].
`8/2002 Langberg eta].
`/2002 Greenha1gh
`8/2002 Chouinard eta].
`9/2002 Snyders
`/2002 Lentzeta].
`
`NORRED EXHIBIT 2235 - Page 3
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`US 7,914,569 BZ
` Page 4
`
`2002/0138138 A1
`2002/0151970 A1
`2002/0161392 A1
`2002/0161394 A1
`2002/0193871 A1
`2003/0014104 A1
`2003/0023300 A1
`2003/0023303 A1
`2003/0028247 A1
`2003/0036791 A1
`2003/0040771 A1
`2003/0040772 A1
`2003/0040792 A1
`2003/0050694 A1
`2003/0055495 A1
`2003/0065386 A1
`2003/0069492 A1
`2003/0069636 A1
`2003/0109924 A1
`2003/0114913 A1
`2003/0125795 A1
`2003/0130726 A1
`2003/0130729 A1
`2003/0139804 A1
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`NORRED EXHIBIT 2235 - Page 6
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