111111
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`1111111111111111111111111111111111111111111111111111111111111111111111111111
`US 20120041323Al
`
`(19) United States
`c12) Patent Application Publication
`TAYLOR et al.
`
`(10) Pub. No.: US 2012/0041323 A1
`Feb. 16, 2012
`(43) Pub. Date:
`
`(54) METHOD AND SYSTEM FOR
`PATIENT-SPECIFIC MODELING OF BLOOD
`FLOW
`
`cation No. 61/402,345, filed on Aug. 27, 2010, provi(cid:173)
`sional application No. 61/404,429, filed on Oct. 1,
`2010.
`
`(75)
`
`Inventors:
`
`Charles A. TAYLOR, Menlo Park,
`CA (US); Timothy A. Fonte, San
`Francisco, CA (US); Ying Bai,
`Belmont, CA (US)
`
`Publication Classification
`
`(51)
`
`Int. Cl.
`A61B 5102
`
`(2006.01)
`
`(73) Assignee:
`
`HeartFlow, Inc.
`
`(21) Appl. No.:
`
`13/014,850
`
`(22)
`
`Filed:
`
`Jan. 27, 2011
`
`Related U.S. Application Data
`
`(62)
`
`(60)
`
`Division of application No. 13/013,561, filed on Jan.
`25,2011.
`
`Provisional application No. 61/401,462, filed on Aug.
`12, 2010, provisional application No. 61/401,915,
`filed on Aug. 20, 2010, provisional application No.
`61/402,308, filed on Aug. 26,2010, provisional appli-
`
`(52) U.S. Cl. ........................................................ 600/508
`
`(57)
`
`ABSTRACT
`
`Embodiments include a system for determining cardiovascu(cid:173)
`lar information for a patient. The system may include at least
`one computer system configured to receive patient-specific
`data regarding a geometry of the patient's heart, and create a
`three-dimensional model representing at least a portion of the
`patient's heart based on the patient-specific data. The at least
`one computer system may be further configured to create a
`physics-based model relating to a blood flow characteristic of
`the patient's heart and determine a fractional flow reserve
`within the patient's heart based on the three-dimensional
`model and the physics-based model.
`
`510
`
`I
`
`p
`Com nary
`
`0.9
`
`0.8
`
`514
`
`0.78
`
`LADFFR= 0.78;LCX FFR= 0.78;
`RCA FFR= 0.79
`
`CATHWORKS EXHIBIT 1009
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`I 07
`
`54
`
`Fig. 1
`
`PREDiCfED
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`Obtain And Preprocess Patient-Specific
`Anatomical Data
`
`100
`.._,/"'
`
`Create Three-Dimensional Model
`Based On Obtained Anatomical Data
`
`......,/' 200
`
`Prepare Model For Analysis And
`Determine Boundary Conditions
`
`300
`..__/""'
`
`Perform Computational Analysis And
`Output Results
`
`...._r-.
`400
`
`Provide Patient-Specific Treatment Planning
`
`..__/""' 500
`
`~
`
`Fig. 2
`
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`:wo,,,\ol
`ArtOi:ry<tnd
`H<mrt
`Segmentation
`
`l'ri.lpam
`Mm:le!ff:lr
`Simulation
`
`Fig, 3
`
`·······lOO
`
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`420 I
`
`220
`
`I
`
`Fig. 4
`
`Fig. 5
`
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`224
`
`222
`
`I
`
`2
`
`230
`Fig. 7
`
`Fig. 6
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`320
`
`/
`
`3
`
`Fig. 8
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`Rest
`
`Maximum Hyperemia
`
`Maximum Exercise
`
`Fig. 9
`
`Fig.10
`
`Fig. 11
`
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`330
`
`/
`
`Fig.13
`
`Fig. 12
`
`Fig. 14
`
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`Fig. 15
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`A: Lumped-parameter heart model
`RAv LAv Rv-Art Lv-Art
`
`8: Windkessel model
`RP
`Rct
`
`\ 340
`
`a-m: Lumped-parameter coronary model
`Ra
`Ra.micro
`
`i
`
`360
`
`i
`
`350
`
`e
`
`Fig. 16
`
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`3 8 0 -l
`
`Fig. 18
`
`...---380
`
`Fig. 17
`
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`Fig. 21
`
`Fig. 22
`
`16 .
`
`. ........ L,A)~ .
`
`Fig. 20
`
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`54
`
`I
`
`Patient Name
`Age= 64
`BP=120/80
`HR=75
`
`lAD cFfR = 0.66
`LCX cFFR = 0.72
`RCA cFfR = 0.8(}
`
`Fig. 23
`
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`INPUTS:
`611
`
`Patient's medica I imaging data
`of coronary arteries and heart.
`l
`
`I
`
`I Patient's brachial blood pressure
`
`measurement.
`
`612
`
`"~"~"~"~"~"~"~"~
`
`---610 1
`
`600
`
`\~~-
`
`MODELS: Generate patient-specific
`geometric model of
`coronary arteries from
`621.---' imaging data.
`
`-· '
`
`62 cr-
`
`Physics-based blood flow
`models:
`-Flow in patient-specific
`622---' coronary geometry.
`-Heart and aortic
`circulation.
`-Distal cor om rv circulation.
`
`\V
`CONDITIONS: Calculate patient -specific 'entricular
`mass from imaging data.
`' ---------
`631
`
`~/
`Calculate resting coronary flow from
`ventricular mass data using
`63~ population-derived relationship
`(Q=CloM").
`
`"\-...,
`
`f---.- 630
`
`'-ii
`Calculate total resting coronary
`633.---' resistance I rom coronary I low and
`blood pressure.
`--!,
`DisLribuLe LoLalcoronary resistance Lo
`individual arteries based ond istal
`vessel sizes using populalion-derived
`634..---' relationship (R=R,da)
`
`~i
`Adapt model conditions based on
`635..---' physicalconditions: hyperemia,
`exercise, medication, etc.
`i
`
`SOLUTION:
`
`40-
`6
`
`\V
`Solve blood flow models in patient-specific
`geometric model using population-derived
`flow and resistance conditions customized
`to the patient.
`
`-------641
`
`Fig. 24
`
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`US 2012/0041323 A1
`
`Fig. 25
`
`510
`
`I
`
`I 0.7
`
`14
`
`0.78
`
`LAD FFR= 0.78; LCX FFR= 0.78;
`RCAFFR= 0.79
`
`CATHWORKS EXHIBIT 1009
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`Patent Application Publication
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`Feb. 16, 2012 Sheet 16 of 31
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`US 2012/0041323 A1
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`520
`
`I
`
`f-,A~)-tJf) \l~}::kxAy {en:/t}
`
`LAD2
`
`LAD4
`
`5;3
`
`3.5
`
`2.9
`
`6.2
`
`H7%
`
`33
`
`<19%
`
`ICX2
`
`1.3
`
`L5
`
`t-9%
`
`Fig. 26
`
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`US 2012/0041323 A1
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`701
`
`I
`
`~m p.atlent specific
`geometric rnod:e!
`::lOd b~ood f~O'><V
`
`E~Ktra p (~ i ;~te
`rest.dt:.> from
`reduced otder
`
`;
`
`704
`
`700
`
`I
`
`702
`
`I
`
`information fro~1 3D
`--····"""""'"""'······· ........ ~;;· slrnubt~on to spe:::lfv
`cond:tions for n~cluced
`order rnodeL
`
`................ -.. ...............
`
`...
`
`""· t
`
`~'
`OD/10 redwcf·d
`
`;
`
`705
`
`703
`
`Fig. 27
`
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`US 2012/0041323 A1
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`710
`
`/
`
`3
`
`71
`
`71
`
`:;irnuiJtion t-o r.:s.sign !ine::::r resi::.hnces t:c
`segme::ts.
`
`use ;:,re>sure/fk::w $.<::,1uuor: frof!-~ multiple 3d s)r:'~U!~tio~::; ot t~s,.~
`rn~-cteis der:ved from p:ev:ous data~o a$.-sig:'l non-~~ne.ar, fiow
`dependent re:s.i·~ta::ces tc..J :$egrner:.ts.
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`718
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`"Cre~te reduced order 0--\i or .L-d b!cod fbw rnodei t.vith tesLst:~::c~s caiti.datect fwn: 3-d
`simut::ti:::-n.
`
`C:-eate user ir.terface to ;a;:m-v interaction \:\lith 3d mode! \!v'here each segment !S:
`seiectCible a0d e-d:tab!e (remove :;tenosi:5, add bvpass .. etc} c:ncl phv::~o!ng~c parameters.
`such a:;. C3rd!;sc output ex-ercis~ !evet hvpererni:a, rnecHc.:::t!ons, etc ~re var:ab!e.
`
`So!ve reduc!C order bleed f!cv:l modet rapidly for each !teratiDn that is generJt-ed by
`t~·lf user.
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`~ ... r:3p b~ooD f!Gw .:m:d pr-essurP. solute:: f:o::-~ fedu(.ed order mode! segments tla(k to 3d
`mDde! for kr:mediate d~·g;:!a:y of resaits:.
`
`719
`
`720
`
`721
`
`722
`
`Fig. 28
`
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`US 2012/0041323 A1
`
`803
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`804
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`800
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`802
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`Fig. 29
`
`CATHWORKS EXHIBIT 1009
`Page 20 of 65
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`Patent Application Publication
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`Feb. 16, 2012 Sheet 20 of 31
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`US 2012/0041323 A1
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`Fig. 30
`
`CATHWORKS EXHIBIT 1009
`Page 21 of 65
`
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`

`Patent Application Publication
`
`Feb. 16, 2012 Sheet 21 of 31
`
`US 2012/0041323 A1
`
`836
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`I
`
`846
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`
`Fig. 31
`
`CATHWORKS EXHIBIT 1009
`Page 22 of 65
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`

`

`Patent Application Publication
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`Feb. 16, 2012 Sheet 22 of 31
`
`US 2012/0041323 A1
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`873
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`874
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`bt·~n~t~ in~\1 ~~~H~h ~eR.~WPt~~d ~'~f$·kHl'1~t
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`Fig. 32
`
`CATHWORKS EXHIBIT 1009
`Page 23 of 65
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`

`Patent Application Publication
`
`Feb. 16, 2012 Sheet 23 of 31
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`US 2012/0041323 A1
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`846
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`904
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`900
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`Fig. 33
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`Fig. 34
`
`CATHWORKS EXHIBIT 1009
`Page 24 of 65
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`Patent Application Publication
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`Feb. 16, 2012 Sheet 24 of 31
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`US 2012/0041323 A1
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`!NI'!Jl$:
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`--------·-·---·-·-------------·-·---·-·---·-·---·-·---·-·---"'·-·---·-----·-----·---·-·---·-·---·-·---·-·---·-·---·-·--
`t <ak:~~att< tnyo.r,~.te'\1'~ pertu~k)n 6$k lttha~~ ~t:e·cl or~ :ft?fOt«rzn~"** v~::4l-Mne r~sk ~nde¥
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`~lt=FhJMon t~~Jt to vu~ntH~~hit ~)!aq:::.m:.
`
`Fig. 35
`
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`Patent Application Publication
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`Feb. 16, 2012 Sheet 25 of 31
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`US 2012/0041323 A1
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`936 I
`
`CT plaque
`co ~11 o osition
`analysis
`
`Plaque Density
`Measurement
`
`Vessel Torsion
`
`Elongating
`
`' 920
`
`Fig. 36
`
`30 blood flow
`
`Flow induced
`force 1 blood
`pre:=.sLlre
`Induced fo.
`and shear
`induced fo
`
`on plaque -- Plaque
`
`Vulnerability = ~
`Index
`Strain
`
`950
`
`CATHWORKS EXHIBIT 1009
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`Feb. 16, 2012 Sheet 26 of 31
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`US 2012/0041323 A1
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`Anterior
`Communicating
`Artery
`
`Posterior
`Communicating
`Artery
`
`External
`Carotid Arteries --c:::+____,_:
`
`Fig. 37
`
`CATHWORKS EXHIBIT 1009
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`Patent Application Publication
`
`Feb. 16, 2012 Sheet 27 of 31
`
`US 2012/0041323 A1
`
`I Patient's brachial blood pressure
`
`measurement.
`
`1012
`
`1000
`
`I
`
`.._/"" INPUTS:
`1010
`1011-....r-
`
`Patient's medical imaging data
`of aorta, carotid, vertebra I,
`cerebral arteries, and brain.
`
`I
`
`*"
`MODELS: Generate patient-specific
`geometric model of
`1021.._......, arteries from imaging data.
`
`1020
`,._r
`
`Physics-based blood flow
`models:
`-Flow in patient-specific
`1022_...... geometry.
`-Heart and aortic
`circulation.
`-Distal Intra/Extra cranial
`circulation.
`
`SOLUTION:
`
`104 0...J""
`
`>l-··
`Solve blood flow models in patient-specific
`geometric model using population-derived
`flow and resistance conditions customized
`to the patient
`
`"'---1041
`
`CONDITIONS: Calculate patient-specificbrain and/or r 1
`
`'V
`
`head volume from irnogingdata.
`\;
`Calculate resting cerebral flow from
`brain/head volume data using
`population-de rived relations hip
`(Q=OoM").
`
`'if
`Calculate total resting cerebral
`resistance from cerebral flow and
`blood pressure.
`
`i/
`Distribute total cerebral resistance to
`individual arteries based on distal
`vessel sizes using papulation-derived
`relationship I R=R.,d~)
`
`,~,·
`
`Adapt model conditions based on
`physicalconditions: stress, exercise,
`medication/ baroreceptor response/
`etc.
`
`031
`
`032
`H
`
`(-
`
`
`
`10 33
`
`
`
`10 34
`
`r--1030
`
`10
`35
`
`Fi g.38
`
`CATHWORKS EXHIBIT 1009
`Page 28 of 65
`
`

`

`Patent Application Publication
`
`Feb. 16, 2012 Sheet 28 of 31
`
`US 2012/0041323 A1
`
`1 052~ INPUTS:
`
`Patienrs rTt"dkctl inldf1}ngd(.1tJ
`of a{)rta, c:::r)t~d, 'i-t:~rtPbnl~,
`Cf·rebra:; artt:fie'j, and hrain.
`
`/1054
`)
`
`1050 I
`
`Di~:s.pi;Jype~·hJs:ion res~..J!t:s -on 30 br~~fn
`~ncHJe!.
`
`1070
`
`Fig. 39
`
`CATHWORKS EXHIBIT 1009
`Page 29 of 65
`
`

`

`Patent Application Publication
`
`Feb. 16, 2012 Sheet 29 of 31
`
`US 2012/0041323 A1
`
`INPUTS:
`
`1100 I
`
`1102
`
`S(:gn··:ent brain b<·JS.~:.~d on th€ di~~t,1~ ve~s0! '.>ilt
`C"Elf ~~'dt!·! cc•rvb~-~~i br~) nch
`
`'11
`
`Cre~'fh.?next genPnHio n of branct·1e'1 in tho
`u~<t~brJI trf~·t:. i\s~:ign br~:mch ~~i~~e~ bd~~cd on
`rnorphornetrlt ~l go r·~th ms ~1nfJ d~~ta.
`
`Furthc-,,sepnwnt the b1ilin b<mni en the <HhV
`brdnch v~'2.50'is.
`
`Rcpf'.1 t lJ nt1l th~-., ,\n1aHr?~t tk,,~~ r~>d hrt-3 nch f)f
`brain VOhJrn(' ~jze j~ Ob t~~~ :1Ct] [ ~\'f~, ckt~-~,m to
`rhsol i) !:ion of
`
`Fig. 40
`
`U:~~~ t:.t:nt~~tlitl0\ horn c~:rob rat
`Vf;~;s.(:l~ in .Srnagtn~~ ft-21t~;',
`
`the iligori\IW'l to tsranth
`vt~:ssebh~'l~ed on rh:eir \ac~~tion
`'-.i\"ft.h~ n tht.< 3D ${~gn1l~ntc'd
`VO!iJti~i.:.:>.
`
`114
`
`116
`
`'120
`
`122
`
`CATHWORKS EXHIBIT 1009
`Page 30 of 65
`
`

`

`Patent Application Publication
`
`Feb. 16, 2012 Sheet 30 of 31
`
`US 2012/0041323 A1
`
`1150
`
`I
`
`)
`
`)
`
`b- {)Od pri.~':.ic~iure_, 'l~~a-rt
`r0te. f;tc
`
`1 ....
`
`'
`
`1152--...__ l!\lf'UTS;
`
`1153
`(
`
`rnaginhda:t;;I ('/
`3 tHt~1~ CHOtid.
`l<'~rt-t'bnr:, (:('~-e=bnd
`;J fte·rk~~, <Jnd lH~$ in
`
`116o--.ur<: :;;;;;~~~;;;--,
`
`i.Htt~de~-
`
`11
`
`$lrnuk~tf~ hh:Jod no~~v Dn.:t:i
`pntS§t~re~:'}~>:rcbtJ! art0r&s
`~-<=ndf:t· ri.:-~:;t,. t:~xt:rct::-{\
`b,:sron::crrtor rosporne,
`r""'h~·dir«1tiors, t~tr
`
`((wn~t-~ re ";)r;rtJ f,Jtf;d
`p0~·fu~:()n =._,<,dfh r'tH!{:)~ur~"d
`[)0tfu>Ol1
`
`1172
`
`Upd,:1te blood f!o>A,· JYN}di..~l
`b{.,"\Und~ny cor~:d !tlon'~. Rf.:.'fi.Jn
`~. kn d,~tkit! ~w~d ftt1rd b::~ untd
`~--~P'I u:i:JtfJt10 HC: t110d$UfEd
`Pio.~dt)s.:on rn)t(h.
`
`k.....11 7 4
`
`{',:)in ~;~,tP f'i:'.~:th P:-:J0:n tr~::: m ('~~~rh ;'Y""reh r_.:).l
`brdnch in(e e~~ch ·2f\tr:n:·nt=·::d vclu'Th~.
`
`Fig. 41
`
`CATHWORKS EXHIBIT 1009
`Page 31 of 65
`
`

`

`Patent Application Publication
`
`Feb. 16, 2012 Sheet 31 of 31
`
`US 2012/0041323 A1
`
`1202
`
`1210
`
`1203
`
`1204
`
`1212
`
`B!OMfCH>\Nltl\lANAlYSIS;
`
`1200 I
`
`1220
`
`·~·~~]
`
`1214
`c~--····----··----··----···---···--c. _________________ ----··----···---··
`~ Pb(~_tu0n·1;J(k'thH det(;,rrnir:ir,g~-;ixH~u~"?
`··---~ (ornpo,;;~tion ,;1r:d prcp?::·n~e: trorn ir:n~w~ng
`~ tS-~~tJ
`L-----·---c-:-c:-:----- =========
`__________________ c!.~-~-~- ______________ ;;::···
`r V~»d W<lil nqde! loc C<li'1P0ting ····························)··
`
`l._~tr~~~\/:rtr~)tn ~0;.q:~s~:(J :lnd phqt;( _ ___
`
`__
`
`__
`
`(:.olnPOl'!ii' p~.e~;.§~~:r!::" ~nd :i-.h~af :~·~rc-~\ ~kting Oil
`li:Jd(!tJ~ lmnin~d ~od+~(~ dH~ tu h-t:~ln(..~dvrh'Jfnk
`~~~~~~ ~~~~ ~~~~ ~~~~ ~~~~ ...
`f~-:.,n:E<:~dm-in:f): r~~-;t_ ~->~erdt·~~. ('h
`L1222
`
`224
`
`-··· .o-mt~t1ti~ th·t--;:~ •)n p~ih':}H:f· d~'f' t~)
`he!nt--d)>n~mk -for(:t.·~ :.:tnd !Wot: h n~t::.:.:~m~nt­
`ijtd~~r~d :::.tE·~~~f~.
`
`Ca!t:I.J~~tt~ v~aq LK: f\Jpturc-vu ~nHElb\!it'i ind<~x b~1~t~d t.J:f1 l1t:rnndynJrr:·:c ~;ttc~~s, ::::trc:s~~
`fr(•r:p . .lcnti t~tft-i;~din::~uk~n:. ~~tid/or ~)!aqlK' Yttength/propcrt:·c~.
`
`··:>
`
`C~1l(:;\lldt(1< t~:robf~)} v~)~umc ri~~- k~d<?x b~"]>~d on plaque \i\lfn<"r~b~! ~tv i nde->:(O~'Ythlnf'd
`~-«.,.-ith JD ~-K:·rnc~Jyna rn~;;: ~i!:'!U!a tionto dt:jt{'rrn~nc \,Vh[;~ ::} i upt"un:5d p~~~qS..l-1.:5 t.ould fi(n,.\·· ~1nd
`t~t~ot:")t~ntt: ~~ :-'!~iV)$ (")f v\~::=,$.~;.-~ ~nd ~d ~i:~ of ~H(•t::'tt~d ~~n~~:~,
`
`C.a!{ulJt('' t0r:t,bt~~ f pG-rfus~c~n rfs.:k i ~1d-t:x b~~'5:0d tH"l <"0fi"hr.:~ ~ vzJ:·wi1~~ rl:* k:d£2'::-.:. s:ornbln•,;.•d
`>:.-~,dth 3D hcn·~c(tyn~1 r:·)~~: ~~irnuiati-::.-:---n to dct-::u1·ttnc- potentia~ ft-t1 uc:hcr~ ln perft.6kn·1 due to
`\tu~nerabk: pfaqu(.
`
`Fig.42
`
`CATHWORKS EXHIBIT 1009
`Page 32 of 65
`
`

`

`US 2012/0041323 AI
`
`Feb. 16,2012
`
`1
`
`METHOD AND SYSTEM FOR
`PATIENT-SPECIFIC MODELING OF BLOOD
`FLOW
`
`PRIORITY
`
`[0001] This application claims the benefit of priority from
`U.S. Provisional Application No. 61/401,462, filed Aug. 12,
`2010, U.S. Provisional Application No. 61/401,915, filed
`Aug. 20,2010, U.S. Provisional Application No. 61/402,308,
`filedAug. 26,2010, U.S. Provisional Application No. 61/402,
`345, filed Aug. 27, 2010, and U.S. Provisional Application
`No. 61/404,429, filed Oct. 1, 2010, which are herein incor(cid:173)
`porated by reference in their entirety.
`
`TECHNICAL FIELD
`
`[0002] Embodiments include methods and systems for
`modeling of fluid flow and more particularly methods and
`systems for patient-specific modeling of blood flow.
`
`BACKGROUND
`
`[0003] Coronary artery disease may produce coronary
`lesions in the blood vessels providing blood to the heart, such
`as a stenosis (abnormal narrowing of a blood vessel). As a
`result, blood flow to the heart may be restricted. A patient
`suffering from coronary artery disease may experience chest
`pain, referred to as chronic stable angina during physical
`exertion or unstable angina when the patient is at rest. A more
`severe manifestation of disease may lead to myocardial inf(cid:173)
`arction, or heart attack.
`[0004] A need exists to provide more accurate data relating
`to coronary lesions, e.g., size, shape, location, functional
`significance (e.g., whether the lesion impacts blood flow), etc.
`Patients suffering from chest pain and/or exhibiting symp(cid:173)
`toms of coronary artery disease may be subjected to one or
`more tests that may provide some indirect evidence relating to
`coronary lesions. For example, noninvasive tests may include
`electrocardiograms, biomarker evaluation from blood tests,
`treadmill tests, echocardiography, single positron emission
`computed tomography (SPECT), and positron emission
`tomography (PET). These noninvasive tests, however, typi(cid:173)
`cally do not provide a direct assessment of coronary lesions or
`assess blood flow rates. The noninvasive tests may provide
`indirect evidence of coronary lesions by looking for changes
`in electrical activity of the heart (e.g., using electrocardio(cid:173)
`graphy (ECG)), motion of the myocardium (e.g., using stress
`echocardiography ), perfusion of the myocardium (e.g., using
`PET or SPECT), or metabolic changes (e.g., using biomark(cid:173)
`ers).
`[0005] For example, anatomic data may be obtained non(cid:173)
`invasively using coronary computed tomographic angiogra(cid:173)
`phy (CCTA). CCTA may be used for imaging of patients with
`chest pain and involves using computed tomography (CT)
`technology to image the heart and the coronary arteries fol(cid:173)
`lowing an intravenous infusion of a contrast agent. However,
`CCTA also cannot provide direct information on the func(cid:173)
`tional significance of coronary lesions, e.g., whether the
`lesions affect blood flow. In addition, since CCTA is purely a
`diagnostic test, it cannot be used to predict changes in coro(cid:173)
`nary blood flow, pressure, or myocardial perfusion under
`other physiologic states, e.g., exercise, nor can it be used to
`predict outcomes of interventions.
`[0006] Thus, patients may also require an invasive test,
`such as diagnostic cardiac catheterization, to visualize cora-
`
`nary lesions. Diagnostic cardiac catheterization may include
`performing conventional coronary angiography (CCA) to
`gather anatomic data on coronary lesions by providing a
`doctor with an image of the size and shape of the arteries.
`CCA, however, does not provide data for assessing the func(cid:173)
`tional significance of coronary lesions. For example, a doctor
`may not be able to diagnose whether a coronary lesion is
`harmful without determining whether the lesion is function(cid:173)
`ally significant. Thus, CCA has led to what has been referred
`to as an "oculostenotic reflex" of some interventional cardi(cid:173)
`ologists to insert a stent for every lesion found with CCA
`regardless of whether the lesion is functionally significant. As
`a result, CCA may lead to unnecessary operations on the
`patient, which may pose added risks to patients and may
`result in unnecessary heath care costs for patients.
`[0007] During diagnostic cardiac catheterization, the func(cid:173)
`tional significance of a coronary lesion may be assessed inva(cid:173)
`sively by measuring the fractional flow reserve (FFR) of an
`observed lesion. FFR is defined as the ratio of the mean blood
`pressure downstream of a lesion divided by the mean blood
`pressure upstream from the lesion, e.g., the aortic pressure,
`under conditions of increased coronary blood flow, e.g.,
`induced by intravenous administration of adenosine. The
`blood pressures may be measured by inserting a pressure wire
`into the patient. Thus, the decision to treat a lesion based on
`the determined FFR may be made after the initial cost and risk
`of diagnostic cardiac catheterization has already been
`incurred.
`[0008] Thus, a need exists for a method for assessing coro(cid:173)
`nary anatomy, myocardial perfusion, and coronary artery
`flow noninvasively. Such a method and system may benefit
`cardiologists who diagnose and plan treatments for patients
`with suspected coronary artery disease. In addition, a need
`exists for a method to predict coronary artery flow and myo(cid:173)
`cardial perfusion under conditions that cannot be directly
`measured, e.g., exercise, and to predict outcomes of medical,
`interventional, and surgical treatments on coronary artery
`blood flow and myocardial perfusion.
`[0009]
`It is to be understood that both the foregoing general
`description and the following detailed description are exem(cid:173)
`plary and explanatory only and are not restrictive of the dis(cid:173)
`closure.
`
`SUMMARY
`
`[0010]
`In accordance with an embodiment, a system for
`determining cardiovascular information for a patient includes
`at least one computer system configured to receive patient(cid:173)
`specific data regarding a geometry of the patient's heart and
`create a three-dimensional model representing at least a por(cid:173)
`tion of the patient's heart based on the patient-specific data.
`The at least one computer system is further configured to
`create a physics-based model relating to a blood flow charac(cid:173)
`teristic of the patient's heart and determine a fractional flow
`reserve within the patient's heart based on the three-dimen(cid:173)
`sional model and the physics-based model.
`[0011]
`In accordance with another embodiment, a method
`for determining patient-specific cardiovascular information
`using at least one computer system includes inputting into the
`at least one computer system patient -specific data regarding a
`geometry of the patient's heart, and creating, using the at least
`one computer system, a three-dimensional model represent(cid:173)
`ing at least a portion of the patient's heart based on the
`patient-specific data. The method further includes creating,
`using the at least one computer system, a physics-based
`
`CATHWORKS EXHIBIT 1009
`Page 33 of 65
`
`

`

`US 2012/0041323 AI
`
`Feb. 16,2012
`
`2
`
`model relating to a blood flow characteristic of the patient's
`heart, and determining, using the at least one computer sys(cid:173)
`tem, a fractional flow reserve within the patient's heart based
`on the three-dimensional model and the physics-based
`model.
`[0012]
`In accordance with another embodiment, a non(cid:173)
`transitory computer readable medium for use on at least one
`computer system containing computer-executable program(cid:173)
`ming instructions for performing a method for determining
`patient-specific cardiovascular information is provided. The
`method includes receiving patient-specific data regarding a
`geometry of the patient's heart and creating a three-dimen(cid:173)
`sional model representing at least a portion of the patient's
`heart based on the patient-specific data. The method further
`includes creating a physics-based model relating to a blood
`flow characteristic in the patient's heart and determining a
`fractional flow reserve within the patient's heart based on the
`three-dimensional model and the physics-based model.
`[0013]
`In accordance with another embodiment, a system
`for planning treatment for a patient includes at least one
`computer system configured to receive patient-specific data
`regarding a geometry of an anatomical structure of the patient
`and create a three-dimensional model representing at least a
`portion of the anatomical structure of the patient based on the
`patient-specific data. The at least one computer system is
`further configured to determine first information regarding a
`blood flow characteristic within the anatomical structure of
`the patient based on the three-dimensional model and a phys(cid:173)
`ics-based model relating to the anatomical structure of the
`patient, modifY the three-dimensional model, and determine
`second information regarding the blood flow characteristic
`within the anatomical structure of the patient based on the
`modified three-dimensional model.
`[0014]
`In accordance with another embodiment, a non(cid:173)
`transitory computer readable medium for use on a computer
`system containing computer-executable progrannning
`instructions for performing a method for planning treatment
`for a patient is provided. The method includes receiving
`patient-specific data regarding a geometry of an anatomical
`structure of the patient and creating a three-dimensional
`model representing at least a portion of the anatomical struc(cid:173)
`ture of the patient based on the patient-specific data. The
`method further includes determining first information regard(cid:173)
`ing a blood flow characteristic within the anatomical structure
`of the patient based on the three-dimensional model and a
`physics-based model relating to the anatomical structure of
`the patient, and determining second information regarding
`the blood flow characteristic within the anatomical structure
`of the patient based on a desired change in geometry of the
`anatomical structure of the patient.
`[0015]
`In accordance with another embodiment, a method
`for planning treatment for a patient using a computer system
`includes inputting into at least one computer system patient(cid:173)
`specific data regarding a geometry of an anatomical structure
`of the patient and creating, using the at least one computer
`system, a three-dimensional model representing at least a
`portion of the anatomical structure of the patient based on the
`patient-specific data. The method further includes determin(cid:173)
`ing, using the at least one computer system, first information
`regarding a blood flow characteristic within the anatomical
`structure of the patient based on the three-dimensional model
`and a physics-based model relating to the anatomical struc(cid:173)
`ture of the patient. The method also includes modifying, using
`the at least one computer system, the three-dimensional
`
`model, and determining, using the at least one computer
`system, second information regarding the blood flow charac(cid:173)
`teristic within the anatomical structure of the patient based on
`the modified three-dimensional model.
`[0016]
`In accordance with another embodiment, a system
`for planning treatment for a patient includes at least one
`computer system configured to receive patient-specific data
`regarding a geometry of an anatomical structure of the patient
`and create a three-dimensional model representing at least a
`portion of the anatomical structure of the patient based on the
`patient-specific data. The at least one computer system is also
`configured to determine first information regarding a blood
`flow characteristic within the anatomical structure of the
`patient based on the three-dimensional model and informa(cid:173)
`tion regarding a physiological condition of the patient,
`modifY the physiological condition of the patient, and deter(cid:173)
`mine second information regarding the blood flow character(cid:173)
`istic within the anatomical structure of the patient based on
`the modified physiological condition of the patient.
`[0017]
`In accordance with another embodiment, a non(cid:173)
`transitory computer readable medium for use on a computer
`system containing
`computer-executable progrannning
`instructions for performing a method for planning treatment
`for a patient is provided. The method includes receiving
`patient-specific data regarding a geometry of an anatomical
`structure of the patient and creating a three-dimensional
`model representing at least a portion of the anatomical struc(cid:173)
`ture of the patient based on the patient-specific data. The
`method further includes determining first information regard(cid:173)
`ing a blood flow characteristic within the anatomical structure
`of the patient based on the three-dimensional model and
`information regarding a physiological condition of the
`patient, and determining second information regarding the
`blood flow characteristic within the anatomical structure of
`the patient based on a desired change in the physiologi