||||||||||||||||||||||||||||||||Il||||||||||||||ll|||||||||||||||||||||||||
`
`USOU8465500B2
`
`(12) United States Patent
`Speziali
`
`(10) Patent No.:
`(45; Date of Patent:
`
`US 8,465,500 B2
`Jun. 18, 2013
`
`(54)
`
`'l‘HORASCOPIC HEART VALVE REPAIR
`METHOD AND APPARATUS
`
`(75)
`
`Inventor: Giovanni Speziali. Piltshurgll. PA (US)
`
`(73) Assignee: Mayo Foundation for Medical
`Education and Research. Rochester.
`MN (US)
`
`1281898: 623111.11. 13.1 1. 2.1 l—2.35: 600116.
`600137, 160. 182, 478. 47?-_. 476. 104
`See application tile for complete search history.
`
`(56)
`
`References Cited
`
`U-S’ PATENT DOCUMENTS
`3.667.474 A
`6.-‘I972
`Inpkin cl Ell.
`3.843.840 A
`l0:'l974 Schweizer
`
`( * ) Notice:
`
`Sulnjcet to any disclaimer. the term ofthis
`patent is extended or adjusted under 35
`U.s.C. 1540:) by 811 days.
`
`4-351-345 A
`4'93S'G2-F A
`
`9" [983 Carn‘-’Y
`(“I990 _Y°on
`(Continued)
`
`(21) APFL Nu:
`
`“£813,695
`
`(22)
`
`P("1‘I*‘iIed:
`
`Jan. 19. 2006
`
`(86)
`
`PCT No»
`
`PCT/US2006=‘00l699
`
`§ 371 (C111 1..
`(2). (4) Date:
`
`Jul. 11, 2007
`
`(8?)
`
`(65)
`
`PC 1 Pub Nu: w020U6fU78694
`PCT Pull Dfllci -'l|l- 27-; 2095
`a a
`rlor
`u
`lea Ion
`D t
`P _
`P by t_
`US 200810] 88873 Al
`Aug. 7. 2003
`
`Ell’
`"-‘
`
`FOREIGN PA"l'l£NT DOCUMENTS
`l 039 351 Bi
`T0005
`‘ ‘*3? “" ' “*3
`~"'3“"“
`(Continued)
`()‘l‘[I1ZR PUl31_1(.‘!\‘1‘1()NS
`
`Extended Etlropcan Search Report for EP 0671 3723.5.
`,
`(Continued)
`
`Julian Woo
`Pr.5n.=m'_t‘ l:‘_\‘mriiner
`(lllristopller I. Tcmpletoll
`/l.t'.ri'.9.*r:1:.' :':".\‘aii:fner
`(74) .4!!orne_i-'. Ageirf. or First: — Qtlarles & Brady LLP
`(57)
`ABSTRA( T1‘
`An instrtunent for pcrlorming lhorascopic repair of heart
`valves includes a shall for extending through the chest cavity
`and into a heart chamber providing access to a valve needing
`repair. A movable tip on the shalt is operable to capture a
`valve leaflet and a needle IS operable to penetrate a captured
`valve leaflet and draw the suture through the leaflet. The
`suture is thus fastened to the valve leaflet and the instrument
`is withdrawn from the heart chamber transporting, the suture
`outside the heart chamber. ‘1‘he suture is anchored to the heart
`wall with proper tension as detennined by observing valve
`operation with an ultrasonic imaging system.
`
`14 Claims, 10 Drawing Sheets
`
`(60)
`
`(51)
`
`(52)
`
`Related U-S- -\PPllC=ifi0fl Data
`pmvisimml appficamm N“ ()m()45‘67-L mud on Jan
`21° 2005‘
`Int CL
`A 613 17/04
`U_S_ CL
`USPC
`(58) Field ofClassifieation Search
`USPC.‘
`6061139. 144. I45. I5. 16. 205 21]:
`
`(200601)
`
`606!,139:606n44
`
`
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`
`Page 1 of 19
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`Page 1 of 19
`
`

`
`US 8,465,500 B2
`Page 2
`
`1281898
`
`5991423
`
`us, PATENT DOCUMENTS
`4-952-498 A
`911990 Cami 941-
`4.959.424 A *
`1911999 Grootcrs
`4.922.824 A
`1111999 15511151
`5-959991 A
`19-999‘ A5”
`5997-535 A
`39994 9'99‘
`51394435 A
`“"994 W9"
`5.312.423 A
`5.-1994 1155511311191 5151.
`5335329 A
`39994 -9°93
`5-93‘-999 A
`79995 5”-“°"3”‘L
`5-‘‘53-733 A
`91995 S‘°‘‘“““ ‘"9
`5.542.455 A
`811996 3151155555151.
`5.521.215 A
`1111995 515115555151.
`5.553.215 A
`811992 M515 5151.
`5.552.422 A *
`911992 2151151111.
`................... .. 5991194
`5.552.423 A *
`911992 5111 51111.
`.. 5991194
`
`5.552.428 A *
`911992 51512511115151.
`5991182
`1211992 Larson. 11. 5151.
`5.593.991 A
`5-753-458 "
`“"993 W”-"8 °”"-
`5.252.513 A
`511998 3511555151.
`5.222.592 A *
`511998 Goldbergeretal.
`57'73-973 A
`99999 T°3"3“9‘
`:1 ‘V
`Bcnaron eta].
`5.292.959 A
`811998 515115515151.
`5.839.231 A
`1111998 051551.11.
`5339-539 A
`‘"1999 S‘*‘”°’°”"-
`5.892.564 A
`411999 Schtllzeetal.
`5-993-‘‘38 A
`59999 5“‘i““" °“"-
`5~993~“39 A
`59999 Y"°“
`5-919-'39 A
`79999 99°"
`5.951.449 A
`1911999 Schwaich. 11.51211.
`5.922.939 A
`1911999 13111113555151.
`6.022.360 A
`212000 Rcimcls ctal.
`6.045.497 A
`412000 Sc11wcich.Jr.ct:1].
`5.959.935 A
`4.-"2999
`551111151511. 11.51111.
`5.959.215 A
`512999 551111151511. Jr. 51 21.].
`5.922.214 A
`512999 515111515151.
`5"”-‘A4 A
`99999 -“°"“"””“‘
`9139-533 A
`191.3999 541°" “W
`9449-959 A
`""2999 "““9°””9'
`9'52-934 A
`“"9999 H*”P°""'“"‘
`6.162.168 A
`1212000 Sc1'1we1c11. Jr. at al.
`6.165.119 A
`1212000 §chw'c1ch. .lr.ctal.
`6.165.120 A
`1212000 5c1'1wc1ch.Jr.ctal.
`5.155.183 A
`1212999 Kuchn 51111.
`5.128.345 131*
`112991 Ammadson 51111.
`5.183.411 131
`212991
`3151115151111.
`5.199.352 131
`212991
`5511511515].
`5.234.995 Bl
`512991 P9aco1:k.III
`5.245.929 Bl
`512991
`'.-\1ub1‘ese1a.1.
`5.259.552 B1
`2.-2991
`515111515151.
`5.251.222 131
`212991
`35115151511. 11.51111.
`5.254.592 131
`212991
`31519515151.
`9-299-919 9‘
`9999‘
`‘9““"-
`5.229.598 Bl
`812991 Kliemanetal.
`9-333-993 9‘
`9999] 9°53-'°"°°““‘
`6.312.447 131
`1112001 Grilnes
`5.332.853 131
`1212991 551111151511. Jr. 5151.
`5.332.854 Bl
`1212991
`55115511-11.11.5111.
`5.332.893 Bl
`1212991
`515111515151.
`'5-3-'‘5~959 9'
`39992 A“9"‘-“‘”‘°]-
`5.491.229 131
`512992 s15v511se1a1.
`6.402.629 131
`612002 M-:1111e1'eIal.
`5.492.589 B2
`512992 11151115151 al.
`5.492.281 Bl
`512992 I.angbergeIa].
`5.495.429 131
`512992 .\1cc51111y51a1.
`5.419.525 131*
`212992 21555 ........................... .. 5991199
`5.435.192 131
`812002 Wangcta].
`5.443.922 Bl
`912992 21513511151111.
`6.451.054 Bl
`912002 Stevens
`6.461.366 Bl
`100.2002 seguin
`5.598.222 131
`112993 3155591115151.
`5.514.194 B2
`212993 85115151511.
`.11. 51 111.
`5'533_';95 Bl
`3.12003 ga_uerela[_
`5.537.193 Bl
`3.1'2m}3
`\.'id]um[et a[_
`5.532.314 132
`312993 Langbcrg 51111.
`5.551.331 132
`412993 5155155515].
`6.558.416 B2
`512003 Cosgrovcctal.
`5.552.952 132
`512993 31513155 51 111.
`
`599.-"423
`
`512993 1251115511 51111.
`5.554.895 132
`321533?
`E§i?..".?1‘Z‘.‘1‘i'1‘».'.1'
`333129? 31
`02003 50000020. Jr_0“0_
`03093100 00
`8,2003 (_.0sgmem0‘
`0000000 0.
`912993 vi111un11e1a1.
`5515584 Bl
`912993 1115111515151.
`55199291 B2
`912993 131511.11 51 51
`5'522'229 132
`00.2003 (mg
`0'02g'0-I0 Bl,
`912993 A1155
`5"525'939 B1
`1912993 51.125.-1151.-11.
`5529534 131
`1912993 Schweich. 11.51111.
`5.529.921 131
`”__..,003 Gm
`0040 205 0,
`0:004 5000005010]
`0'0..0'200 Bf,
`25004 K0000 0. E0 ‘
`5'005'060 B]
`0.5004 0 mgberg 0020‘
`0‘000'4..6 00
`4.2004 mavkaeml
`0'.“0‘005 00
`4,2004 S0_0mdcm'0
`0‘.,.,3‘030 01
`0,2000 Nobles W0 ‘
`0‘0.:;..'000 02
`512994 1555 51111.
`'
`5'221E1"192 B2
`'0f..,004 Qionicmtal
`0‘.M0'4.“ B,
`0.3004 03010000 01 £0
`0'.,50'0l3 05
`512994 Schweich Jr L151
`5255222 132
`Vidlllnd £0: a],
`B-J
`0.2004 Begum
`'
`5'T,.0'003 03
`0.0004 0301 eta]
`5'T,.0‘004 0.
`912994 5511515151‘ Jr 5151
`5293518 132
`loéum (.Mgm0c'e“'fl
`6'00-,‘860 B1,
`‘
`1912994
`911311151 51 51.
`5'89§‘488 B2
`1112994 1angbcTget 111.
`5819882 B2
`11'2995
`fmwnjng
`6840.246 132 *
`40.0005 Grimes
`0'00.5'2,4 05
`0.0005 O.Q0.mn ma]
`0‘003'4;0 00
`7602005
`‘denier et al
`6'908'4-,4 B2
`-J0.-2005 guyen at al'
`6'918'9I-0, Bl
`0.2005 00000“ at al‘
`0'021‘40., B2
`0__...,005
`‘H0000 em ‘
`0'020‘n.. B2
`0.5005 (.00
`'
`0‘005'00;. 02
`1912995 515151115151.
`529552125 B2
`1112995 Cosgrm1eel'a.l.
`5.952.595 B2
`1212995 111115111
`5928125 132*
`112995 3115111151.51‘51W'""m'"'H"
`5985225 132
`"2006 Lashinskidfi
`6:989:03 B3
`2012006 Chawla
`6.997.950 B2
`2.-1,006 La”
`7004176 B-,
`'“
`'
`'
`‘
`_§:§0?_ §?n':f]:§'“"
`;'3?‘I‘:Eg§ E3
`_.
`.
`gjégfi
`3:320:29; 2%
`.-
`033$; 33 Egg E::']:'J';::‘°]‘
`7'003'030 05
`0.0000 “mm
`7'000'000 02
`0.2000 000105010]
`‘
`7‘004‘.,44 B2
`0.-2000 gchmk
`21999514 132
`912995 Stevens e1 51
`'
`7'm'20.. 00
`0.5000 M001 ct al
`221122219 132
`912995 'vi5111nd 5151.
`7'”9‘993 B2
`992999 0‘Q“i"" 9”"
`7.122.040 B2
`1011006 Hiil eial.
`,
`.,
`..
`;':;g‘;;: 33
`$33; E°d”£:‘;:t':t"al
`71189199 132
`3112992
`\11cCart11yc1a1
`.’,_m..240 02
`0.200., Snow
`7 1.25 45? B2
`6012007 Lucatcmfl 0]‘
`7';4..‘134 0,
`05.00, 0.00000 eta]
`0.'§.50'0,0 05
`03,000 00001 0“.
`.0.‘-2:00‘0§7 00
`.0500? 000001
`'
`'
`2.294.148 B2
`1112992 ..\1cc11191y
`;‘2:.‘$:g' 3%
`[$3333 g:’:’fA:|‘9"""A‘
`7.563.262 132
`712009 Goldfarb clal.
`7-553-373 33
`"A9999 G°‘*“3"“’ ‘"3"
`7-5941545 B2
`1012999 ‘§°1"**'"b 2'31-
`2.608.091 132
`1012009 (mldfarb et a1.
`2.666.204 B29‘
`212010 Thornton 01 a1.
`7.815.654 B2
`1012010 C119
`2.829.948 B2
`2.-"2911 Bain etal.
`7.887.552 B2
`2.-‘"2011 Bachman
`299119995282 A1* 512%1e ryland
`Exhibit 1006
`
`‘
`
`600044
`
`I
`
`'
`
`‘
`
`‘
`
`'
`
`'
`
`1281898
`
`59219
`
`6061190
`
`Page 1 of 19
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`Page 1 of 19
`
`

`
`US 8,465,500 B2
`Page 3
`
`.. 62352.1
`
`. 6065145
`
`.... .. 6065139
`
`.... .. 606-"144
`
`. 6065139
`
`200150016675
`200150021872
`200250013571
`200250029080
`200 250049402
`200 250077524
`200250169359
`200250173694
`2002.50 1 83766
`2003500 04 562
`2003500329 79
`200350050529
`200350050693
`20035007 8600
`200350105519
`200350130731
`2003.501 669 92
`200350167071
`200350171641
`200350181928
`200350195529
`200350199975
`200450003819
`200450030382
`20045003 9442
`2004500443 50
`2004.-"0044365
`200450049207
`200450049552
`2004500879 75
`2004500879 78
`200450092962
`200450122448
`200450127983
`200450133063
`200450167374
`2004.-"0167539
`200450225300
`200450225304
`2004.502 363 54
`2004.-"02432 29
`200-'-‘I.-"02670 83
`200550021055
`200 5.5'002 1056
`200550021057
`200 55003 3446
`200 5.5006 5396
`200 55'007 57 23
`200 55007 57 27
`200550101975
`200550125011
`200550131277
`200550131533
`200550143620
`200550143815
`200550149014
`200550154402
`200550165419
`200550171601
`200550216039
`200550240202
`20055025 1 1 87
`200650020275
`2006500363 17
`200650041306
`200650052868
`200650058871
`2006500744 35
`2006.5008967I
`200650100699
`200650127509
`2006.5'013 5993
`200650149 I 23
`2006.5'0161040
`200650161193
`200650184203
`200650195012
`200650195134
`200650241340
`
`A1
`A1
`A1
`A1
`Al
`Al
`Al
`(‘I
`A1
`('\I
`A1
`A1
`A1
`Al
`Al ’“
`Al
`A1
`(‘I
`(“I
`('\I
`{‘I *
`A1
`A1
`A1
`Al
`A1
`A1
`(\I
`(“I
`Al
`A1
`A1
`A1 *
`
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`{KI
`A1
`A1 “‘
`A1
`A1
`A1
`Al
`Al
`A1
`A1
`(‘I
`A1
`(«I
`A1
`A1
`A1‘
`Al
`Al
`Al
`A1
`(‘I
`(\I
`('\I
`A1
`A1
`A1
`Al
`Al
`A1
`A1
`A1
`A1
`A1
`A1
`Al
`A1
`A1
`(‘I
`
`3.52001
`0.52001
`1.52002
`3.52002
`4.52002
`5.-2002
`1 1.52002
`1 152002
`12.52002
`1.52003
`2.52003
`3.52003
`3.52003
`4.52003
`5.52003
`2.52003
`0.52003
`052003
`052003
`052003
`10.52003
`1052003
`152004
`252004
`2.52004
`3.52004
`3.52004
`352004
`3.52004
`552004
`552004
`5.52004
`552004
`252004
`2.52004
`3.52004
`3.52004
`1 152004
`1 1.52004
`1 1.52004
`1252004
`1252004
`1.52005
`I 52005
`1.52005
`2.52005
`3.52005
`4.52005
`4.52005
`5.52005
`552005
`552005
`552005
`5.52005
`2.52005
`2.52005
`2.52005
`2.52005
`3.52005
`0.52005
`10.52005
`1 1.5'2005
`1.2005
`2.52005
`2.52005
`352005
`352005
`4.52005
`4.52005
`5.52005
`5.52005
`5.52005
`252005
`2.52005
`2.52005
`3.52005
`3.52005
`3.52005
`10.52005
`
`Morlier el al.
`Bailey at :1].
`Goldfiarh el al.
`3510013: 01 a1.
`Peacock. 111 ct 211.
`Schweich. Jr. el 21].
`Nlccarthy e1 21].
`Morticr cl al.
`Scguin
`1)iCa.rlo
`551011101‘ el al.
`Vidlund ct a1.
`Quijano et a1.
`0‘Q11i11n el al.
`Fasol .21 al.
`Vidlund et al.
`Schweich. Jr. el 21.].
`Martin ct al.
`Schwcich. Jr. ct a].
`Vidlund et al.
`Takamoto cl :1].
`Gahbay
`St. Goa: at a].
`St. Goa: at a].
`Si. Gear: 1:! a].
`Martin et al.
`Bachman
`Goidfarb el al.
`Motoyarna el al.
`Lucatcro el al.
`Velez 01 0.1.
`Thomton et a1.
`Lcvinc .................. ..
`Morticr ct al.
`McCarthy et al.
`Schweich et a1.
`Kuehn at a].
`Goldfzuh el al.
`Vidlund er al.
`Seguin
`Vidlund ct al.
`McCarthy er al.
`'1bubia ct al.
`St. (3021: 5:1 3].
`51. Gear at a].
`Deem el al.
`Monier el al.
`Schroeder et al.
`W'hea.t1ey
`Nguyen er al.
`Spence ct al.
`Schwcich. Jr. at al.
`Alficri ct al.
`Morticr 01 31.
`551011101‘ el al.
`Hauck et a].
`Sauer 01 a1.
`Sauer el al.
`Cosyuve el 21.].
`I..edem1an
`Shcnriib ct al.
`Beans ct al.
`Goidfitrb et al.
`\5’i1i|unc1 et al.
`Vidlund et a1.
`Monier 01 a1.
`Zakay ct a1.
`Realyvasqtlevt
`Guldfarb el al.
`Vidluml et al.
`Eckman 01 al.
`Scguin
`Vidlund et al.
`_\5IcCa.11hy er al.
`Bean:-: et a1.
`-.\5I2lr1in el al.
`Mortier el al.
`Criltenden
`Vidlund ct al.
`
`....... ..
`
`200650287657 A1
`200750002627 A1
`200750027451 A1
`200750049952 A1
`200750050022 Al
`200750055303 AI
`200750088375 Al
`200750100356 A1
`2007.5'0II2244 A
`200750118154 A1
`200750118155 A1
`200750129737 A1
`200750197858 A1
`200750203391 A1
`200750232941 Al
`200750239272 Al
`200750265643 A1
`200750299468 A1
`200850051703 A1
`200850065011 A1
`200850065156 A1
`200850065205 A1
`200850091059 A1
`200850091264 A1
`200850097489 Al
`2008.-"0167714 AI
`200850183194 A1
`200850188873 A1
`200850195200 A1
`200850208006 A1
`200850228223 A1
`200950105729 A1
`200950105751 A1
`200950131880 Al
`200950156995 A1
`200950163934 A1
`200950259304 A1
`
`12.52 005
`1.52 002
`252002
`352002
`3.52002
`3.52002
`4.52002
`552002
`552002
`5.52002
`5.52002
`5.52002
`3.52002
`3.52002
`1052 002
`10.52002
`1 1.52002
`1252002
`2.2003
`3.52003
`3.52003
`3.52003
`452003
`452003
`452003
`252003
`2.52003
`352003
`352003
`352003
`052003
`452000
`4.52000
`5.52000
`5.52000
`5.52000
`1052 000
`
`Bachman
`Youn
`Desinger c1 .11.
`Weiss
`Vidlund er a1.
`Vinilund el 3].
`Beam: er a].
`LLIcatcr0 cl .1].
`;\dcCart]1}5 ct .1].
`Crablrec
`Go1dfa.rh 01 a1.
`Goldfarh 01 a1.
`(ioldfarb et a1.
`Bloom at al.
`Rabiuovich
`Navia et al.
`Beane er a].
`Viola
`Thornton cl al.
`Marchand et a1.
`I-Iauser el al.
`Nguyen et a1.
`Machold ct al.
`Machold at al.
`Guidfzirh el al.
`51. Goa: et 21].
`Goidfarb el :11.
`Speziali
`Vidlund el a].
`Fan
`Alkhatib
`Zentgraf
`Zentgraf
`Speziali et 211.
`Martin et :11.
`Raschdorf. Jr. 21 a1.
`0‘Bcirnc el al.
`
`EP
`EP
`EP
`
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`
`FOREIGN PATENT DOCUMENTS
`1 845 861
`A2
`1052002
`1 408 850
`B 1
`052000
`12.52000
`I 845 861
`A4
`06142 1 14
`55 1004
`W0 99.5'00059
`151000
`W0 99530647
`551000
`W0 00506026
`2.2000
`W0 00506026
`2.52000
`W0 00506027
`2.52000
`2.52000
`W0 00506027
`2.52000
`W0 00506028
`W0 00516700
`3.52000
`W0 0 1.5'660 1 8
`0.52001
`W0 01595809
`12.52001
`035001893
`1.52003
`W0 03.-"059209
`2.52003
`W0 035059209
`2.52003
`W0 035082 157
`1052003
`W0 035082 157
`1052003
`2004021893
`3.52004
`W0 20045043265
`5.52004
`W0 20045043265
`552004
`W0 20055039428
`5.52005
`W0 20055039428
`5.52005
`W0 20055094525
`10..-2005
`W0 20065032051
`3.52005
`W0 20065032051
`3.52005
`W0 20065065966
`5.52005
`5.52005
`W0 20065065966
`W0 20065078694
`2.52005
`W0 20065078694
`2.52005
`W0 2006.-"I 16310
`1 152005
`W0 200651 16310
`1 1.52005
`W0 20065127509
`1 152005
`W0 20065127509
`1 1.52005
`W0 20075002627
`1.52002
`W0 20075027451
`3.52002
`W0 20075027451
`3.52002
`W0 20075062128
`5.52002
`W0 20075062128
`
`A2
`A3
`A2
`A3
`A 1
`
`A1
`A 1
`A2
`A2
`A3
`A2
`A3
`A1
`A2
`A3
`A2
`A3
`A2
`A2
`A3
`A2
`A3
`1&2
`A3
`A2
`A3
`A2
`A3
`A 1
`A2
`A3
`A2
`3
`e
`
`00! Ggvrd v. Univ of Maryland
`Exhibit 1006
`
`Page 1 of 19
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`Page 1 of 19
`
`

`
`US 8,465,500 B2
`Page 4
`
`W0
`W0
`W0
`W0
`W0
`
`W0 2007.-‘U814 [8
`W0 2{J0'.I'v'l [7612
`WC) 2008-0 [0738
`WO 20095052 528
`WU 200‘).-"U52 528
`
`A I
`A 1
`A2
`A2
`A 3
`
`T5200?
`I0-"2{JO'a'
`I 52008
`4- 2009
`4.1200‘)
`
`Ol‘II]£R l-’UI3I.I(.‘_’\'l‘I[)NS
`
`Pm1Au:-sess Syslern for MiImlVa1ve Repair Proves llsvalue in Study;
`MedGadge1 Jul. 9. 2009; available at: hllp:.-".-'\.vww.n1edgadget.comu’
`a:chivcs.='2009-'07-"poI1__acccss___ syslcm_t'or__1ni lraI__ valve ___re-
`pair_proves_its_va|uc_in_sludy.hlm|. ('5 pages).
`Interact ive C.'a.rdioVasculaJ' and Thoracic Surgery: Abstracts: Supple»
`rrlenlal 310 vo1.T(Sep.2flD8).52 pages.
`
`filed Oct. 20. 2003.
`U.S.App1.No. l2;'254.807.
`filed Oct. 20. 2008.
`U.S..»\pp1.No. I2.-254.308.
`PCT Search Report and Written Opinion for PC"l‘.-“U806-"D1699.
`PCT International Preliminary Report on Patcnlabilily for PCT
`US2UOS."08U56(J.
`
`|2.r‘254.80'}".
`U.S. Appl_ No.
`U.S.App1.No. 12-'254.3U8.
`U.S..»'\pp1.I\'o.
`I lf3l3.fi95.
`LI.S.App1.1\'o. I2.-'?()9.220.
`[IS 6. |97.052. U3e"200 l. C'osgm\«'c cla1.(wilhdrawn)
`
`* cited by examiner
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`
`Page 1 of 19
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`Page 1 of 19
`
`

`
`U.S. Patent
`
`Jun. 18,2013
`
`Sheet 1 of 10
`
`US 8,465,500 B2
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`
`Page 1 of 19
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`Page 1 of 19
`
`

`
`U.S. Patent
`
`Jun. 18,2013
`
`Sheet 2 of 10
`
`US 8,465,500 B2
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`
`Page 1 of 19
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`Page 1 of 19
`
`

`
`U.S. Patent
`
`Jun. 13, 2013
`
`Sheet 3 of 10
`
`US 8,465,500 B2
`
`\
`180
`
`\
`
`100
`
`160
`
`FIG. 6B
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`
`Page 1 of 19
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`Page 1 of 19
`
`

`
`U.S. Patent
`
`Jun. 13, 2013
`
`Sheet 4 of 10
`
`US 8,465,500 B2
`
`
`
`FIG. 8B
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`
`Page 1 of 19
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`Page 1 of 19
`
`

`
`U.S. Patent
`
`Jun. 13, 2013
`
`Sheet 5 of 10
`
`US 8,465,500 B2
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`
`Page1of19
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`Page 1 of 19
`
`

`
`U.S. Patent
`
`Jun. 13, 2013
`
`Sheet 6 of 10
`
`US 8,465,500 B2
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`
`Page 1 of 19
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`Page 1 of 19
`
`

`
`U.S. Patent
`
`Jun. 13, 2013
`
`Sheet 7 of 10
`
`US 8,465,500 B2
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`
`Page 1 of 19
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`Page 1 of 19
`
`

`
`U.S. Patent
`
`Jun. 18,2013
`
`Sheet 8 of 10
`
`US 8,465,500 B2
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`
`Page 1 of 19
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`Page 1 of 19
`
`

`
`U.S. Patent
`
`Jun. 18,2013
`
`Sheet 9 of 10
`
`US 8,465,500 B2
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`
`Page 1 of 19
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`Page 1 of 19
`
`

`
`U.S. Patent
`
`Jun. 18,2013
`
`Sheet 10 of 10
`
`US 8,465,500 B2
`
`FIG. 10D
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`
`Page 1 of 19
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`Page 1 of 19
`
`

`
`US 8,465,500 B2
`
`2
`
`1
`THORASCOPIC HEART VALVE REPAIR
`3/[E'l'Il()l) AND APPARATUS
`
`CROSS-REFERENC E TO RELATED
`APPl..l(.‘.»\TIONS
`
`This application claims the benefit of International Patent
`Application Number PCTfUS2006t100l 699 filed 19 Jan. 2006
`and entitled “THORASCOPIC HEART VZALVE REPAIR
`METI-IOIJ AND APl"ARA'l‘US", which claims priority of
`U.S. Provisional Patent Application Ser. No. 60l1645_.6?7 filed
`21 Jan. 2005 and entitled “TI--IOR.I\SC()Pl(“ I IFARTVAI NE
`RFPAIR MIITI-I01") AND APP.’\iU¥IU S". both of wliich are
`incorporated by reference herein.
`_
`_
`_
`_
`, v
`13/1CKGR0U1‘11) 01" 1111'-1 1NV15Ni110N
`
`valve in the valve position, usually by suturing the replace-
`ment valve to the natural valve annulus.
`'various types of
`replacement valves are in current use, including mechanical
`and biological prostheses. homogral’ts. and allografts. as
`described in Bodnar and Iirater. Replacement Cardiac Valves
`1-357 (1991). which is incorporated herein by reference. A
`comprehensive discussion of heart valve diseases and the
`surgical treatment thereof is found in Kirklin and Barran-
`lioyes. Cardiac Surgery 323-459 (1986), the complete disclo-
`sure of which is incorporated herein by reference.
`The mitral valve. located between the left atrium and left
`ventricle ofthe heart, is most easily reached through the wall
`of the left atrium. which normally resides on the posterior side
`ofthe hetztrt. opposite the side of the heart that is exposed by
`a median sternotomy. Tlierelore. to access the mitral valve via
`15 a sternotomy. the heart is rotated to bring the lefi atrium i11to
`a position accessible through the sternotomy. An opening. or
`atriotomy. is then made in the left atrium. anterior to the right
`pulmonary veins. The atriotoiny is retracted by means of
`Various types of surgical procedures are currently per-
`sutures or a retractititt device,
`t3xpQ5il]g the mitral valve
`l‘Dl'I11E!d toinvestigate. diagnose.andtreat diseases oflhe l1t;3Zll'l
`311 directly posterior to the atriotomy. One of the fore mentioned
`and 11113 E1931 V13551315 01-11113 l11‘11'3X- 51-11311 Pl'0CCdlll'l35 lllcilldtif
`techniques may then be used to repair or replace the valve,
`repair and replacement of mitral. aortic, and other heart
`An alternative technique for iujtral valve access may be
`valves. repair ofatrial and ventricular septal delects. pulmo-
`used whena median sternotomy andfor rotational ma11ipula-
`1131)’ 1111'011111'3‘5111111Y- 11135111119111 01 511113111'Y-‘51'115- 131*’-'C11'0P11)'31'
`tiuh cf the l'le;1l"[ are tu1de5irable_ 1:; this tcclmlquc, at large
`c-logical mapping and ablation of the rnyocarditun. and other
`procedures in which intervcntional devices are introduced 25 incisionis made in the right lateralside ofthechest. usually in
`il110 I113 iI11t3t'i0I' 01‘ tilt! 119311 01' 8 E11331 VESSBI.
`the region oftlie fifth intercostal space. One or tnore ribs may
`Using current
`techniques. many of these procedures
`be removed from the patient. and other ribs near the incision
`require at gross thoracotomy, usually in the form of a median
`are retracted outward to create a large opening into the tho-
`stemototny, to gain access i11to the patient’s thoracic cavity. A
`racic cavity. The left atrium is then exposed 011 the posterior
`saw or other cutting instrument is used to cttt the sternum 3tl side ofthe heart, and an an-gummy is fm-medj11thewa1]0fthe
`longitudinally. allowing two opposing halves oftlie anterior
`left at;-ium_ thmttgh which the l'l1i1l';t] valve may be accessed
`or ventral portion of the rib cage to be spread apart. A large
`for repair or l-eplacet-hcht_
`opening into the thoracic cavity is thus created.
`through
`Using such open-chest techniques. the large opening pro-
`which the surgical team may directly visualize and operate
`vided by a median sternotomy or right thoracotomy enables
`upon the heart and other thoracic contents.
`35 the surgeon to see the mitral valve directly llimngll the left
`Surgical intervention within the heart generally requires
`an-iotoniy. and to position his orher hands within the thoracic
`isolation of the heart and coronary blood vessels from the
`cavity in close proximity to the exterior of the heart
`tor
`rclllélindtir of lllc zltttrriéll system. and ztrresl of Cardiac fiItlt-'-
`manipulation of surgical instruments, removal of excised tis-
`tion. Usually. the heart is isolated from the arterial system by
`sue. andfor introduction of a replacement valve through the
`introducing an external aortic cross-clamp through a stemo- 4t‘: ht,-ietomy for attachment within the heart. However. these
`toiuy and applying it totheaorta between the brachiocephalic
`invasive, open-chest procedures produce a high degree of
`artery Ell-ld 1113 coronary 0Sli3- Cardioplegic fillld 15 111311
`tr'auma.a significant risk ofeomplications. an extended hos-
`injected into the coronary arteries. either directly into the
`pita] stay. anda painful recovery period forthe patient. More-
`coronary ostia or through a puncture in the aortic root. so as to
`over. while heart valve surgery produces beneficial results for
`arrest cardiac function. In some cases. cardiuplcgic fluid is 45 many patients, numerous others who might benefit from sttch
`iltjt-‘cltld in10 the coronary Sinus for rclmgradc ptirfllsioll Of
`surgery are unable or unwilling to undergo the trauma and
`the myocardium. The patient is placed on cardiopulmonary
`risks cl‘ current techniques.
`bypass to maintain peripheral circulation of oxygenated
`The mitral and tricuspid valves inside the llulllan heart
`b100d-
`include an orifice (annulus). two (for the mitral) or three (for
`Ofparticular interest to the present invention are intracar— 50 the tricuspid) leaflets and a subvalvular apparatus. The sub-
`diac ]3J'0C€C1Ut'€S
`lb!‘ Surgical ifeatln-‘3l1l0f11-‘cart WINES. 3593-
`valvular apparatus includes multiple chordae tendinae. which
`cially lllt-‘ mitral and aflrtit-‘ Valves. Aticordiltg 10 rcccllt cSti-
`connect the mobile valve leaflets to mttscular structures (pap-
`rllalcs. H1011’-' titml 79,000 patients are diaglloscd With aortic
`illary muscles) inside the ventricles. Rupture or elongation of
`and mitral valve disease in US. liuspitals each year. More
`the Chordae tendinae result in partial or generalized leaflet
`than 49.000 mitral valve or aortic valve replacement proce- 55 prolapse, which causes mitral {or tricuspid) valve regurgita-
`51111“-‘3 31"? l3el'f01’111eC1 511111115111)’ 111 1113 Uvsu 5110113 W1111 51 518'
`lion. A commonly used technique to surgically correct mitral
`nificant number of heart valve repair procedures.
`valve regurgitatioit is the implantation of artificial chordae
`Various surgical techniques may he used to repair a dis-
`(usually 4-0 or 5-0 Gore-Tex sutures) between the prolapsing
`cased or damaged vslvc. including anrmloplasty (contracting
`segment olithe valve and the papillary muscle. This operation
`the valv= annulus). quadrangular resection [narrowing the an is generally carried out tltmttgh 21 median gtemctcmy and
`V5111’? 1t-‘311€15)-
`301111111551-"‘T110111)’ (Cl-1111113 1119 "E11119 °0111111l5'
`requires cardiopulmonary bypass with aortic cross-clamp and
`sures to separate the valve leaflets). shortening mitral or tri-
`cat-dicplegjc an-est cl‘ the hem-t,
`cuspid valve chordae tendonae, reattachment of severed
`mitral or tricuspid valve chordae tendonae or papillary
`muscle tissue, and decalcification of valve and annulus tissue.
`Alternatively. the valve may be replaced, by excising the
`valve leaflets of the natural valve. and securing a replacement
`
`lil
`
`SUMMARY OF THE INVENTION
`
`65
`
`The present iltvention is a method and apparatus for per-
`forming a minimally illvifilétlO1
`'|i\r/ (gfl'lR?flary|and
`Exhibit 1006
`
`Page 1 of 19
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`Page 1 of 19
`
`

`
`3
`
`4
`
`US 8,465,500 B2
`
`is beating. More specifically the
`valves while the heart
`method includes inserting an instrument through tl1e subject's
`chest wall and through the heart wall. The instmrnent carries
`on its distal end a movable element which is manipulated to
`grasp a valve leallet and hold it while a needle mechanism
`punctures the valve leaflet and loops at suture around a portion
`of the valve leaflet. The instrt.tme11t is withdrawn from the
`
`FIG. 8C is a detailed isometric view of the preferred
`embodiment of the suture deployment system showing the
`needle retracting back through the leaflet to pull the suture
`loop back through the puncture opening in the leaflet.
`FIG. SI) is it detailed isometric view of the preferred
`entbodilllellt of the suture deployment system showing the
`distal end of the instntment releasing the leaflet and pulling
`both ends and the midpoint of the suture as the instrument
`withdraws from the patient‘s heart.
`FIG. HE is a detailed side elevation view of the preferred
`embodiment of the suture deployment where the suture is
`released from the instrument and the two suture ends are
`
`heart along with the suture and the suture is tied offat the apex
`ofthe heart afler adjusting its tension for optimal valve opera-
`tion as observed with an ultrasonic imaging system.
`In addition to grasping and needle mechanisms. the instru-
`ment includes fiber optics which provide direct visual indi-
`inserted through the loop.
`cation that the valve leaflet is properly grasped. A set of
`FIG. SF is a detailed side elevation view of the preferred
`illuminating fibers terminate at the distal end of the instru-
`15 embodiment of the suture deployment system wherein the
`.
`.
`.
`.
`ends of the suture are pulled and the loop of the suture slides
`mum ammd lheilieedle mechanism 1” “loaf: pmmmly 10 fl 531
`back along the suture to form a Larks head around the edge of
`°f5*m§“'r fil?°m' 111° Sensor fibers “Galley 11311} fmm the distal
`the valve leaflet.
`end oi the instrument to produce an image lor the operator.
`FIG. 9A is a detailed isometric view of a second embodi-
`“lite” 3 Val“? leaflet l5 Pi'°P°i'l}’ ET35P9d- light lmin the l“'-‘'
`minating fibers is retlccted oltthe leaflet surface back through an mm; “[1113 Sum,-c dcptuymum System stmwiug the lip aft}-“.3
`the S3550)‘ fibers. Oil the other hand. the valve leaflet iS £101
`distal end [of the jn_stn_“nen[
`the hean valve ];-gaflet
`properly grasped the 5611501‘ fibers 563 blood.
`and showing a suture that is a closed loop with one end of the
`A general object of the invention is to provide an instru-
`loop disposed in the tip of the instrument and the other end
`ment zmd procedure which enables heart valves to be repaired
`disposed in the lumen and wrapped around the needle.
`without the need for open heart surgery. The instrument is
`FIG. 9B is a detailed isometric view of a second embodi-
`inscrted through an opening in the chest wall and intoa heart
`ment of the suture deployment system showing the needle
`chamber while the heart is heating. The instrument enables
`puncturing the leaflet and pushing the suture through the
`repair of a heart valve. after which it is withdrawn from the
`leaflet.
`heart and the chest.
`FIG. 9C‘ is a detailed isometric view of a second embodi-
`
`ill
`
`25
`
`l3Rll.5l’ Dl3S(7Ril’'l‘l0N 01’ 'i‘l'll3 DRAWINGS
`
`50
`
`3U ment ofthe suture deployment system showing the needle
`retracting back through the leaflet to pull the looped suture
`back through the opening in the leaflet and showing the
`instrument releasing the leaflet.
`FIG. 1 is a cut-out view of a paticnt’s chest showing an
`FIG. 9]) is a detailed isometric View org second Q1]]b[_]dj-
`instrumerit embodying the invention being inserted into a
`patictJI’S Cile‘-it Cc'lV’il)/ through E1
`tl10l’‘¢7|S00PlC [3011 that
`i5 35 r11enl ofthe suture deployment system showing t.he instru-
`insefted into ill-‘J pail-‘-‘t1i'S Cllesi.
`ment withdrawing to slide the unhooked end of the suture
`FIG. 2 is a cut-cut view c.-fa paticnfs chest showing an
`along the length of the needle towards the leaflet to form a
`instrument embodying the invention grasping a prolapsing
`La]-ks head around me leanerg i,-dge_
`segment of the mitral valve inside the paticnt’s chest cavity
`FIG. 10A is a detailed isometric view of at third embodi-
`Elllld 5ECllI'll'lg. an Zl.l’llfi.ClE|l Cl10l'Ci-El t0 the FY99 edge Of the ['ll'0- 40 m_e11|_ rjfthc suture deplgylnent gystgm ghgwillg the tip gfthe
`l3P5iIlg Segment Gillie l11i1I'3lVfilV€-
`distal end of the instrument grasping the heart valve leaflet
`FlG. 3 i5 3 Clil-01lt\’i€W Ulla patictlfs Cl1e5tC3Vit)’ showing
`and showing the midpoint oi‘ the suture being looped around
`an instrument embodying the invention tensioning the neo—
`the lumen and the two loose ends ofthe suture being coiled up
`implanted Cllordfl.
`in the tip of the distal end of the instrument.
`FIG. 4 is anisomctric view ofan instrument embodying the 45
`[-'1G_ 108 is a detailed igumeu-ac View ufa 111;,-(3 gmbudj-
`invention. Fifi. Sis a detailed isometric view ofthe distal end
`ment of the 51]1|_|re dep[uyme111'_ systeru 3l1gwi1]g the needle
`of an instrument embodying the invention.
`puncture and push the suture through the leaflet and through
`FIG. i5.‘\ iii 2! d€i?1il€‘d
`S-idf-' elf-'V3ii0l1 Vii-‘W Gillie distal end 0i‘
`the loop oi‘ the Free ends of the suture wherein the needle then
`an instruinent embodying the invention showing the tip in a
`h[_)[)ks the frog ends or1]](3 gum;-u_
`Clofied position.
`FIG. 10C is a detailed isometric view of a third embodi-
`FIG. 53 ifiadetailed Side elevation View oi'Il1-‘J distal end 0i‘
`ment of the suture deployment system showing the needle
`an instrument embodying the invention showing rods inside
`retracting back througltthe leaflet and showing the irtstrurrtent
`the instrument that are capable of sliding to move the tip to an
`relua si113 [tug [ed [1.«_-1_
`013611 position.
`FIG. 1013 is a dctai led isometric view ofa third embodi-
`l"lG. 7 is 3 detailed i$o|11E=1l‘iC View Ulllllo difiifll oltd oi all 55 ment of the suture deployment system showing the instru-
`inslmmei‘-l
`‘3mb0dYi113 the ii‘-“'3”-‘i011 511°-'Wi113 the 1‘-Bed]?
`ment withdrawing from the heart to pull the free ends of the
`lumen and four fiberoptic channels that are disposed around
`suture back through the valve leaflet and fbmuug a Lark-5
`the needle lumen.
`head aroturd the lea flet‘s edge by the midpoint of the suture.
`FIG. 8A is a detailed isometric view of the preferred
`embodiment of the suture deployment system showing the an
`positioning ofa heart valve leaflet with respect to the instru-
`ment.
`
`l)lj’I'AILl'.iD DESCRIP’l'lON O1*"l'[-[E P[{l'~LFl£RRli-ZD
`EMBODIMENT
`
`Under general anesthesia and double-lumen ventilation.
`FIG. 8B is a detailed isometric view of the preferred
`the patient is prepped and draped so as to allow ample surgical
`embodiment ofthe suture deployment system showing the tip
`of the distal end of the instrument closing 011 the leaflet to as access to the right lateral. anterior and left lateral chest wall
`grasp l.l1e leaflet such that the needle can puncture and push
`(l"rom the posterior axillary li11e o11 one side to the posterior
`the suture through the leaflet.
`axillary line on the ot11erfltée6. 'nVin I-‘ .r_y|and
`Exhibit 1006
`
`Page 1 of 19
`
`NeoChord v. Univ of Maryland
`Exhibit 1006
`Page 1 of 19
`
`

`
`5
`
`US 8,465,500 B2
`
`6
`
`more thoracoscopic ports are inserted in the lefl chest through
`the intercostal spaces and an instrument II) is inserted through
`one of these ports into the chest cavity. Alternatively, a small
`(3-5 cm) lefl thoracotomy is performed in the fifth or sixth
`intercostals space on the anterior axillary line. The patient is
`fully heparinized. After collapsing the left ltmg, the pericar-
`dium overlying the apex 12 ofthe lefl ventricle 14 is opened
`and its edges are suspended to tl1e skin incision line. This
`provides close access to the apex ofthe heart. Guidance ofthe
`intracardiac procedure is provided by a combination of
`transesophageal or
`intravascular echocardiograplty {not
`shown in the drawings) and with direct visttalization through
`a I'iber—optical system built into the irtstrttment 1!} as will be
`described in