throbber
111111
`
`1111111111111111111111111111111111111111111111111111111111111111111111111111
`US 20140200867Al
`
`(19) United States
`c12) Patent Application Publication
`LAVI et al.
`
`(10) Pub. No.: US 2014/0200867 A1
`Jul. 17, 2014
`(43) Pub. Date:
`
`(54) VASCULAR FLOW ASSESSMENT
`
`Publication Classification
`
`(71) Applicant: CathWorks Ltd, Tel-Aviv (IL)
`
`(72)
`
`Inventors: Ifat LAVI, Moshav Mishmeret (IL); Ran
`Kornowski, Ramat-HaSharon (IL); ldit
`Avrahami, Rosh HaAyin (IL); Nessi
`Benishti, Kfar-Saba (IL); Guy Lavi,
`Moshav Mishmeret (IL)
`
`(73) Assignee: CathWorks Ltd, Tel-Aviv (IL)
`
`(21) Appl. No.: 14/040,688
`
`(22) Filed:
`
`Sep.29,2013
`
`Related U.S. Application Data
`
`(60) Provisional application No. 61/752,526, filed on Jan.
`15, 2013.
`
`(51)
`
`(52)
`
`(2006.01)
`(2006.01)
`
`Int. Cl.
`G06F 19100
`G06T 17100
`U.S. Cl.
`CPC .......... G06F 1913431 (2013.01); G06T 171005
`(2013.01)
`USPC .............................................................. 703/2
`
`ABSTRACT
`(57)
`A method for vascular assessment is disclosed. The method
`comprises receiving a plurality of2D angiographic images of
`a portion of a vasculature of a subject, and processing the
`images to produce a stenotic model over the vasculature, the
`stenotic model having measurements of the vasculature at one
`or more locations along vessels of the vasculature. The
`method further comprises obtaining a flow characteristic of
`the stenotic model, and calculating an index indicative of
`vascular function, based, at least in part, on the flow charac(cid:173)
`teristic in the stenotic model.
`
`PRODUCE A STENOTIC :tv10DEL OF A SUBJECT'S
`VASCULAR SYSTEM
`
`~ "' 1910
`
`+
`OBTAIN A FLOW CHARl\.CTERISTIC OF THE STENOTIC K
`MODEL •
`+
`
`PRODUCE A SECOND MODEL OF A SIMILAR EXTENT
`
`OF THE PATIENT'S VASCULAR SYSTEM AS THE ~ -
`
`STENOTIC MODEL
`
`1915
`
`1920
`
`OBTAIN THE FLOW CHARACTERISTIC OF THE
`N0Rl'v1AL MODEL
`
`K
`
`'1925
`
`+
`CALCULATE AN TNDEX TNDTCA TTVE OF THE NEED r-- 1930
`FOR REV ASCULARIZA TION
`
`CATHWORKS EXHIBIT 1005
`Page 1 of 31
`
`

`

`Patent Application Publication
`
`Jul. 17, 2014 Sheet 1 of 10
`
`US 2014/0200867 A1
`
`FIGURE 1
`
`FIGURE 2
`
`CATHWORKS EXHIBIT 1005
`Page 2 of 31
`
`

`

`Patent Application Publication
`
`Jul. 17, 2014 Sheet 2 of 10
`
`US 2014/0200867 A1
`
`CATHWORKS EXHIBIT 1005
`Page 3 of 31
`
`

`

`Patent Application Publication
`
`Jul. 17, 2014 Sheet 3 of 10
`
`US 2014/0200867 A1
`
`CATHWORKS EXHIBIT 1005
`Page 4 of 31
`
`

`

`Patent Application Publication
`
`Jul. 17, 2014 Sheet 4 of 10
`
`US 2014/0200867 A1
`
`r---------r·------T ___________ l___________________________________
`
`~
`
`1-t:
`
`CATHWORKS EXHIBIT 1005
`Page 5 of 31
`
`

`

`Patent Application Publication
`
`Jul. 17, 2014 Sheet 5 of 10
`
`US 2014/0200867 A1
`
`~~
`-.a.. r.:
`
`··· ... ·· ..
`
`fj,..
`N/.
`
`I!
`
`0 ..........
`0:::
`0
`1-
`0
`UJ >
`UJ
`w
`0:::
`1-
`
`CATHWORKS EXHIBIT 1005
`Page 6 of 31
`
`

`

`Patent Application Publication
`
`Jul. 17, 2014 Sheet 6 of 10
`
`US 2014/0200867 A1
`
`l{)
`
`.....
`00
`.....
`I
`
`0
`N
`co
`.....
`
`I!)
`N
`ro
`..-
`
`!
`\
`
`.~
`
`6''
`li
`?':-<
`""l
`~
`0
`~
`0
`w
`~
`Q
`··········"'"
`~ .............
`:M
`0
`'>"'!
`~
`&...!
`8
`ttl
`""'
`Q
`(.)
`~
`Q
`rt··1
`
`·»!.~
`
`...
`...
`
`<:.t:o
`
`·""''
`~~;.
`1t
`"""
`·~::a
`~
`M
`~
`""'~
`~t.:
`~
`<tii
`w
`Q.
`~
`)~
`0'i
`•l'Ma
`t:"ii
`~
`0
`~
`IJ..,j
`
`~=·:.
`
`- ~··~
`
`~-~
`
`~~
`()
`iJ)
`i1J
`.~
`"""'
`'""' 0
`·.t.::J
`"""'
`(.;')
`.w
`M,j
`~
`~ ..... y
`d
`• '>"! M
`~~ ... ~ ,...,,
`._
`!,.,.o
`~ •0
`tJ
`• ""'!
`~ ~""""
`~ ()
`(,)
`'tl
`,.,.,j
`I,)
`f;iJ)
`~-~
`0
`,,..,...,.
`+~
`!Hi
`0 w
`- l;).j)
`' rn t~
`.....
`~:.( .~
`w.
`o. ...
`.....
`i:t!
`~
`~
`er ~
`!)J) """
`·- ·¥
`.,..,
`·~
`~ ·~
`~ u
`A m
`w. ·~ ~
`
`(U
`"tj
`
`•:>i"j
`
`.~
`
`co
`lU
`0:::
`:J
`(9
`lL
`
`CATHWORKS EXHIBIT 1005
`Page 7 of 31
`
`

`

`Patent Application Publication
`
`Jul. 17, 2014 Sheet 7 of 10
`
`US 2014/0200867 A1
`
`fk" - ..... 1910
`
`PRODUCE A STENOTIC MODEL OF A SUBJECT'S
`VASCULAR SYSTEM
`
`t
`OBTATN A FLOW CHARACTERISTIC OF THE STENOTIC f.*- - ...... 1915
`t
`
`MODEL
`
`PRODUCE A SECOND MODEL OF A SIMILAR EXTENT
`OF THE PATfENT'S VASCULAR SYSTElvl 1\S THE
`STENOTIC MODEL
`
`t
`
`OBTAJN THE FLOW CHARACTERISTIC OF THE
`NORMAL MODEL
`
`•
`
`CALCULATE AN INDEX INDICATIVE OF THE NEED
`FOR REVASCULARIZAT10N
`
`,.,---- 1920
`
`~ -. 1925
`
`f..V-
`
`1930
`
`FIGURE 9
`
`CAPTURE A PLURALITY OF 2D JMAGES OF THE
`SUBJECT'S VASCULAR SYSTEM
`
`t
`
`PRODUCE A TREE MODEL OF THE SUBJECT'S
`VASCULAR SYSTEM
`
`t
`
`PRODUCE A MODEL OF A FLOW CHARACTERfSTIC OF
`THE TREE MODEL
`
`-
`~ 2010
`
`~ -
`
`2015
`
`-~ 2020
`
`FIGURE 10
`
`CATHWORKS EXHIBIT 1005
`Page 8 of 31
`
`

`

`Patent Application Publication
`
`Jul. 17, 2014 Sheet 8 of 10
`
`US 2014/0200867 A1
`
`2100
`
`FIGURE 11
`
`CATHWORKS EXHIBIT 1005
`Page 9 of 31
`
`

`

`Patent Application Publication
`
`Jul. 17, 2014 Sheet 9 of 10
`
`US 2014/0200867 A1
`
`2205
`: ....... ,. ........... .,.,., ~ .. o,.,.,.,..,,...._.,,. &"''"•"'""'
`·--
`:
`r---~--~-------~
`'
`' '
`
`:!
`
`;
`
`.._/
`/ - - .........
`
`/
`
`/
`
`/
`
`.........
`/
`
`2209
`
`COMPUTER
`2210
`
`FIGURE 12A
`
`CATHWORKS EXHIBIT 1005
`Page 10 of 31
`
`

`

`Patent Application Publication
`
`Jul. 17, 2014 Sheet 10 of 10
`
`US 2014/0200867 A1
`
`~ ....... ., ........................ ...
`
`..................... ..
`P---~------~
`
`#
`
`#
`
`.,.....,.. .. '
`, ..
`..,.,....
`..
`..
`..
`..
`..
`"
`"' " " , ..
`-., ..
`...........
`......
`
`#
`
`~~
`
`..._ .........
`--·
`,...... .
`,.,
`'\."
`, '
`' ,
`.....
`'
`.........
`'
`'
`~""
`\ '
`....
`'
`'
`.....
`.. ~
`' ...... ,
`......
`'
`_ ..........
`
`2235
`"" ....................... ..
`,
`:
`
`'
`. . . '
`
`'
`
`........ ··. ·-.
`
`2239
`
`--
`................... ,......
`...
`__ .....
`'
`'
`'
`..,,
`...... -
`'
`'
`..
`'
`"'"" ..
`/
`,'
`I ,
`•
`2239
`
`COMPUTER
`2210
`
`FIGURE 128
`
`CATHWORKS EXHIBIT 1005
`Page 11 of 31
`
`

`

`US 2014/0200867 AI
`
`Jul. 17, 2014
`
`1
`
`VASCULAR FLOW ASSESSMENT
`
`FIELD AND BACKGROUND OF THE
`INVENTION
`
`[0001] The present invention,
`in some embodiments
`thereof, relates to vascular flow assessment and, more par(cid:173)
`ticularly, but not exclusively, to modeling vascular flow and to
`assessing vascular flow.
`[0002] Arterial stenosis is one of the most serious forms of
`arterial disease. In clinical practice, stenosis severity is esti(cid:173)
`mated by using either simple geometrical parameter, such as
`determining the percent diameter of a stenosis, or by measur(cid:173)
`ing hemodynamically based parameters, such as the pressure(cid:173)
`based myocardial Fractional Flow Reserve (FFR). FFR is an
`invasive measurement of the functional significance of coro(cid:173)
`nary stenoses. The FFR measurement technique involves
`insertion of a 0.014" guidewire equipped with a miniature
`pressure transducer located across the arterial stenosis. It
`represents the ratio between the maximal blood flow in the
`area of stenosis and the maximal blood flow in the same
`territory without stenosis. Earlier studies showed that FFR<O.
`75 is an accurate predictor of ischemia and deferral of percu(cid:173)
`taneous coronary intervention for lesions with FFR;;:0.75
`appeared to be safe.
`[0003] An FFR cut-off value of 0.8 is typically used in
`clinical practice to guide revascularization, supported by
`long-term outcome data. Typically, an FFR value in a range of
`0.75-0.8 is considered a 'grey zone' having uncertain clinical
`significance.
`[0004] Modeling vascular flow and to assessing vascular
`flow is described, for example, in U.S. published patent appli(cid:173)
`cation number 2012/0059246 of Taylor, to a "Method And
`System For Patient-Specific Modeling Of Blood Flow",
`which describes embodiments which include a system for
`determining cardiovascular information for a patient. The
`system may include at least one computer system configured
`to receive patient-specific data regarding a geometry of at
`least a portion of an anatomical structure of the patient. The
`portion of the anatomical structure may include at least a
`portion of the patient's aorta and at least a portion of a plu(cid:173)
`rality of coronary arteries emanating from the portion of the
`aorta. The at least one computer system may also be config(cid:173)
`ured to create a three-dimensional model representing the
`portion of the anatomical structure based on the patient-spe(cid:173)
`cific data, create a physics-based model relating to a blood
`flow characteristic within the portion of the anatomical struc(cid:173)
`ture, and determine a fractional flow reserve within the por(cid:173)
`tion of the anatomical structure based on the three-dimen(cid:173)
`sional model and the physics-based model.
`[0005] Additional Background Art Includes:
`[0006] U.S. Published Patent Application No. 2012/
`053918 of Taylor;
`[0007] U.S. Published Patent Application No. 2012/
`0072190 of Sharma eta!;
`[0008] U.S. Published Patent Application No. 2012/
`0053921 ofTaylor;
`[0009] U.S. Published Patent Application No. 2010/
`0220917 of Steinberg et a!;
`[0010] U.S. Published Patent Application No. 2010/
`0160764 of Steinberg eta!;
`[0011] U.S. Published Patent Application No. 2012/
`0072190 of Sharma eta!;
`[0012] U.S. Pat. No. 6,236,878 to Taylor eta!;
`[0013] U.S. Pat. No. 8,311,750 to Taylor;
`
`[0014]
`an article titled: "Determination of fractional flow
`reserve (FFR) based on scaling laws: a simulation study" by
`Jerry T. Wong and Sabee Molloi, published in Phys. Med.
`Bioi. 53 (2008) 3995-4011;
`[0015]
`an article titled: "A Scheme for Coherence-Enhanc(cid:173)
`ing Diffusion Filtering with Optimized Rotation Invariance",
`by Weickert, published in Journal ofVisual
`[0016] Communication and Image Representation; Volume
`13, Issues 1-2, March 2002, Pages 103-118 (2002);
`[0017]
`a thesis in a book titled "Anisotropic Diffusion in
`Image Processing", by J. Weickert, published by B. G. Teub(cid:173)
`ner (Stuttgart) in 1998;
`[0018]
`an article titled: "Multiscale vessel enhancement
`filtering", by A. F Frangi, W. J. Niessen, K. L. Vincken, M.A.
`Viergever, published in Medical Image Computing and Com(cid:173)
`puter-Assisted Intervention-MICCA '98;
`[0019]
`an article titled: "Determination of fractional flow
`reserve (FFR) based on scaling laws: a simulation study", by
`Jerry T Wong and Sabee Molloi, published in Phys. Med.
`Bioi. 53 (2008) 3995-4011;
`[0020]
`an article titled: "Quantification of Fractional Flow
`Reserve UsingAngiographic Image Data", by S. Molloi, J. T.
`Wong, D. A. Chalyan, and H. Le, published in 0. Dassel and
`W. C. Schlegel (Eds.): WC 2009, IFMBE Proceedings 25/II,
`pp. 901-904, 2009;
`[0021]
`an article titled: "Quantification of fractional flow
`reserve based on angiographic image data", by Jerry T. Wong,
`Huy Le, William M. Suh, David A. Chalyan, Toufan
`Mehraien, Morton J. Kern, Ghassan S. Kassab, and Sabee
`Molloi, published in Int J Cardiovasc Imaging (2012) 28:13-
`22;
`[0022]
`an article titled: "An angiographic technique for
`coronary fractional flow reserve measurement: in vivo vali(cid:173)
`dation", by Shigeho Takarada, Zhang Zhang and Sabee Mol(cid:173)
`loi, published online on 31 Aug. 2012 in Int J Cardiovasc
`Imaging;
`[0023]
`an article titled: "A new algorithm for deriving pul(cid:173)
`satile blood flow waveforms tested using stimulated dynamic
`angiographic data", by A. M. Seifalian, D. J. Hawkes, A. C.
`Colchester, and K. E. Hobbs, published in Neuroradiology,
`vol. 31, no. 3, pp. 263269, 1989;
`[0024]
`an article titled: "Validation of a quantitative radio(cid:173)
`graphic technique to estimate pulsatile blood flow waveforms
`using digital subtraction angiographic data", by A. M. Sei(cid:173)
`falian, D. J. Hawkes, C. R. Hardingham,A. C. Colchester, and
`J. F. Reidy, published in J. Biomed. Eng., vol. 13, no., 3 pp.
`225233, May 1991;
`[0025]
`an article titled: "Validation of volume blood flow
`measurements using three dimensional distance-concentra(cid:173)
`tion functions derived from digital X-ray angiograms", by D.
`J. Hawkes, A.M. Seifalian, A. C. Colchester, N. Iqbal, C. R.
`Hardingham, C. F. Bladin, and K. E. Hobbs, published in
`Invest. Radio!, vol. 29, no. 4, pp. 434442, April1994;
`[0026]
`an article titled: "Blood flow measurements using
`3D distance-concentration functions derived from digital
`X-ray angiograms", by A. M. Seifalian, D. J. Hawkes, C.
`Bladin, A. C. F. Colchester, and K. E. F. Hobbs, published in
`Cardiovascular Imaging, J. H. C. Reiber and E. E. van der
`Wall, Eds. Norwell, MA, The Netherlands: Kluwer Aca(cid:173)
`demic, 1996, pp. 425-442;
`[0027]
`an article titled: "Determination of instantaneous
`and average blood flow rates from digital angiograms of
`vessel phantoms using distance-density curves", by K. R.
`
`CATHWORKS EXHIBIT 1005
`Page 12 of 31
`
`

`

`US 2014/0200867 AI
`
`Jul. 17, 2014
`
`2
`
`Hoffmann, K. Doi, and L. E. Pencil, published in Invest.
`Radio!, vol. 26, no. 3, pp. 207212, March 1991;
`an article titled: "Comparison of methods for instan(cid:173)
`[0028]
`taneous angiographic blood flow measurement", by S. D.
`Shpilfoygel, R. Jahan, R.A. Close, G. R. Duckwiler, and D. J.
`Valentino, published in Med. Phys., vol. 26, no. 6, pp.
`862871, Jnne 1999;
`[0029]
`an article titled: "Quantitative angiographic blood
`flow measurement using pulsed intra-arterial injection", by
`D. W. Holdsworth, M. Drangova, and A. Fenster, published in
`Med. Phys., vol. 26, no. 10, pp. 21682175, October 1999;
`[0030]
`an article titled: "Dedicated bifurcation analysis:
`basic principles", by Joan C. Tuinenburg, Gerhard Koning,
`Andrei Rares, Johannes P. Janssen, Alexandra J. Lansky,
`Johan H. C. Reiber, published in Int J Cardiovasc Imaging
`(2011) 27:167174;
`an article titled: "Quantitative Coronary Angiogra(cid:173)
`[0031]
`phy in the Interventional Cardiology", by Salvatore Davide
`Tomasello, Luca Costanzo and Alfredo Ruggero Galassi,
`published in Advances in the Diagnosis of Coronary Athero(cid:173)
`sclerosis;
`an article titled: "New approaches for the assess(cid:173)
`[0032]
`ment of vessel sizes in quantitative (cardio-)vascular X-ray
`analysis", by Johannes P. Janssen, Andrei Rares, Joan C.
`Tuinenburg, Gerhard Koning, Alexandra J. Lansky, Johan H.
`C. Reiber, published in Int J Cardiovasc Imaging (2010)
`26:259271;
`[0033]
`an article titled: "Coronary obstructions, morphol(cid:173)
`ogy and physiologic significance Quantitative Coronary
`Arteriography" by Kirkeeide R L. ed. Reiber J H C and
`Serruys P W, published by The Netherlands: Kluwer, 1991,
`pp 229-44;
`[0034]
`an article titled: "Coronary x-ray angiographic
`reconstruction and image orientation", by Kevin Sprague,
`Maria Drangova, Glen Lehmann, Piotr Slomka, David Levin,
`Benjamin Chow and Robert deKemp, published in MedPhys,
`2006 March; 33(3):707-18;
`[0035]
`an article titled: "A New Method of Three-dimen(cid:173)
`sional Coronary Artery Reconstruction From X-Ray Angiog(cid:173)
`raphy: Validation Against a Virtual Phantom and
`[0036] Multislice Computed Tomography", by Adaman(cid:173)
`tios Andriotis, Ali Zifan, Manolis Gavaises, Panos Liatsis,
`Ioannis Pantos, Andreas Theodorakakos, Efstathios P. Efsta(cid:173)
`thopoulos, and Demosthenes Katritsis, published in Catheter
`Cardiovasc Interv, 2008, January 1; 71 (1 ):28-43;
`[0037]
`an article titled: "Noninvasive Measurement of
`Coronary Artery Blood Flow Using Combined Two-Dimen(cid:173)
`sional and Doppler Echocardiography", by Kenji Fusejima,
`MD, published in JACC Vol. 10, No. 5, November 1987:
`1024-31;
`an article titled: "New Noninvasive Method for
`[0038]
`Coronary Flow Reserve Assessment: Contrast-Enhanced
`Transthoracic Second Harmonic Echo Doppler", by Carlo
`Caiati, Cristiana Montaldo, Norma Zedda, Alessandro Bina
`and Sabino Iliceto, published in Circulation, by the American
`HeartAssociation, 1999; 99:771-778;
`an article titled: "Validation of noninvasive assess(cid:173)
`[0039]
`ment of coronary flow velocity reserve in the right coronary
`artery-A comparison of transthoracic echocardiographic
`results with intracoronary Doppler flow wire measurements",
`by Harald Lethena, Hans P Triesa, Stefan Kersting a and
`Heinz Lambertza, published in European Heart Journal
`(2003) 24, 1567-1575;
`
`an article titled: "Coronary flow: a new asset for the
`[0040]
`echo lab?" by Paolo Vocia, Francesco Pizzuto a and Francesco
`Romeob, published in European Heart Journal (2004) 25,
`1867-1879;
`[0041]
`a review paper titled: "Non-invasive assessment of
`coronary flow and coronary flow reserve by transthoracic
`Doppler echocardiography: a magic tool for the real world",
`by Patrick Meimoun and Christophe Tribouilloy, published in
`European Journal of Echocardiography (2008) 9, 449-457;
`and
`[0042]
`an article titled: "Detection, location, and severity
`assessment of left anterior descending coronary artery
`stenoses by means of contrast-enhanced transthoracic har(cid:173)
`monic echo Doppler", by Carlo Caiati, Norma Zedda, Mauro
`Cadeddu, Lijnn Chen, Cristiana Montaldo, Sabino Iliceto,
`Mario Erminia Lepera and Stefano Favale, published in Euro(cid:173)
`pean Heart Journal (2009) 30, 1797-1806.
`[0043] The disclosures of all references mentioned above
`and throughout the present specification, as well as the dis(cid:173)
`closures of all references mentioned in those references, are
`hereby incorporated herein by reference.
`
`SUMMARY OF THE INVENTION
`
`In some embodiments of the invention, one or more
`[0044]
`models of a patient's vascular system are produced.
`In some embodiments, a first model is produced
`[0045]
`from actual data collected from images of the patient's vas(cid:173)
`cular system. Optionally, the actual data includes a portion of
`the vascular system which includes at least one blood vessel
`with stenosis. In these embodiments, the first model describes
`a portion of the vasculature system which includes at least one
`blood vessel with stenosis. This model is interchangeably
`referred to as a stenotic model. Optionally, the actual data
`includes a portion of the vascular system which includes at
`least one blood vessel with stenosis and a crown. In these
`embodiments the stenotic model also includes information
`pertaining to the shape and/or volume of the crown, and
`information pertaining to blood flow and/or resistance to
`blood flow in the crown.
`In some embodiments the first model is used for
`[0046]
`calculating an index indicative of vascular function. Prefer(cid:173)
`ably, the index is also indicative of potential effect of revas(cid:173)
`cularization. For example, the index can be calculated based
`on a volume of a crown in the model and on a contribution of
`a stenosed vessel to the resistance to blood flow in the crown.
`In some embodiments of the present invention a
`[0047]
`second model is produced from the actual data, changed so
`that one or more stenoses present in the patient's vascular
`system are modeled as if they had been revascularized.
`In some embodiments the first model and the second
`[0048]
`model are compared, and the index indicative of the potential
`effect of revascularization is produced, based on comparing
`physical characteristics in the first model and in the second
`model.
`[0049]
`In some embodiments the index is a Fractional Flow
`Reserve (FFR), as known in the art.
`[0050]
`In some embodiments the index is some other mea(cid:173)
`sure which potentially correlates to efficacy of performing
`revascularization of one or more vessels, optionally at loca(cid:173)
`tions of stenosis.
`[0051] According to an aspect of some embodiments of the
`present invention there is provided a method for vascular
`assessment. The method comprises, receiving a plurality of
`2D angiographic images of a portion of a vasculature of a
`
`CATHWORKS EXHIBIT 1005
`Page 13 of 31
`
`

`

`US 2014/0200867 AI
`
`Jul. 17, 2014
`
`3
`
`subject; and using a computer for processing the images and
`producing, within less than 60 minutes, a first vessel tree over
`a portion of the vasculature.
`[0052] According to some embodiments of the invention
`the vasculature has therein at least a catheter other than an
`angiographic catheter, and wherein the images are processed
`and the tree is produced while the catheter is in the vascula(cid:173)
`ture.
`[0053] According to some embodiments of the invention
`the method comprises using the vascular model for calculat(cid:173)
`ing an index indicative of vascular function.
`[0054] According to some embodiments of the invention
`the index is indicative of the need for revascularization.
`[0055] According to some embodiments of the invention
`the calculation is within less than 60 minutes.
`[0056] According to an aspect of some embodiments of the
`present invention there is provided a method of analyzing
`angiographic images. The method comprises: receiving a
`plurality of 2D angiographic images of a portion vasculature
`of a subject; and using a computer for processing the images
`to produce a tree model of the vasculature.
`[0057] According to an aspect of some embodiments of the
`present invention there is provided a method of treating a
`vasculature. The method comprises: capturing a plurality of
`2D angiographic images of a vascular system of a subject
`being immobilized on a treatment surface; and, while the
`subject remains immobilized: processing the images and pro(cid:173)
`ducing a vessel tree over the vascular system; identifying a
`constricted blood vessel in the tree; and inflating a stent at a
`site of the vasculature corresponding to the constricted blood
`vessel in the tree.
`[0058] According to some embodiments of the invention
`the plurality of 2D angiographic images comprise at least
`three 2D angiographic images, wherein the tree model is a 3D
`tree model.
`[0059] According to some embodiments of the invention
`the method comprises identifYing in the first vessel tree a
`stenosed vessel and a crown of the stenosed vessel, and cal(cid:173)
`culating a resistance to fluid flow in the crown; wherein the
`index is calculated based on a volume of the crown, and on a
`contribution of the stenosed vessel to the resistance to fluid
`flow.
`[0060] According to some embodiments of the invention
`the vessel tree comprises data pertaining to location, orienta(cid:173)
`tion and diameter of vessels at a plurality of points within the
`portion of the vasculature.
`[0061] According to some embodiments of the invention
`the method comprises processing the images to produce a
`second three-dimensional vessel tree over the vasculature, the
`second vessel tree corresponding to the first vessel tree in
`which a stenotic vessel is replaced with an inflated vessel;
`wherein the calculation of the index is based on the first tree
`and the second tree.
`[0062] According to some embodiments of the invention
`the method comprises processing the images to produce a
`second three-dimensional vessel tree over the vasculature, the
`second vessel tree corresponding to a portion of the vascular
`system which does not include a stenosis and which is geo(cid:173)
`metrically similar to the first vessel tree; wherein the calcu(cid:173)
`lation of the index is based on the first tree and the second tree.
`[0063] According to some embodiments of the invention
`the method comprises obtaining a Fractional Flow Ratio
`(FFR) based on the index.
`
`[0064] According to some embodiments of the invention
`the method comprises determining, based on the index, a ratio
`between maximal blood flow in an area of a stenosis and a
`maximal blood flow in a same area without stenosis.
`[0065] According to some embodiments of the invention
`the method comprises minimally invasively treating a
`stenosed vessel.
`[0066] According to some embodiments of the invention
`the treatment is executed less than one hour from the calcu(cid:173)
`lation of the index.
`[0067] According to some embodiments of the invention
`the method comprises storing the tree in a computer readable
`medium.
`[0068] According to some embodiments of the invention
`the method comprises transmitting the tree to a remote com(cid:173)
`puter.
`[0069] According to some embodiments of the invention
`the invention the method comprises capturing the 2D angio(cid:173)
`graphic images.
`[0070] According to some embodiments of the invention
`the capturing the plurality of 2D angiographic images is
`effected by a plurality of imaging devices to capture the
`plurality of 2D angiographic images.
`[0071] According to some embodiments of the invention
`the capturing the plurality of 2D angiographic images com(cid:173)
`prises synchronizing the plurality of imaging devices to cap(cid:173)
`ture the plurality of images substantially at a same phase
`during a heart beat cycle.
`[0072] According to some embodiments of the invention
`the synchronizing is according to the subject's ECG signal.
`[0073] According to some embodiments of the invention
`the method comprises: detecting corresponding image fea(cid:173)
`tures in each ofN angiographic images, where N is an integer
`greater than 1; calculating image correction parameters based
`on the corresponding image features; and based on the cor(cid:173)
`rection parameters, registering N-1 angiographic images to
`geometrically correspond to an angiographic image other
`than the N-1 angiographic images.
`[0074] According to some embodiments of the invention
`the method comprises defining a surface corresponding to a
`shape of the heart of the subject, and using the surface as a
`constraint for the detection of the corresponding image fea(cid:173)
`tures.
`[0075] According to some embodiments of the invention
`the method comprises compensating for breath and patient
`movement.
`[0076] According to an aspect of some embodiments of the
`present invention there is provided a computer software prod(cid:173)
`uct. The computer software product comprises a computer(cid:173)
`readable medium in which program instructions are stored,
`which instructions, when read by a computer, cause the com(cid:173)
`puter to receive a plurality of 2D angiographic images of a
`subject's vascular system and execute the method as delin(cid:173)
`eated above and optionally as further detailed below.
`[0077] According to an aspect of some embodiments of the
`present invention there is provided a system for vascular
`assessment. The system comprises: a plurality of imaging
`devices configured for capturing a plurality of 2D angio(cid:173)
`graphic images of a vascular system of a subject; and a com(cid:173)
`puter configured for receiving the plurality of 2D images and
`executing the method the method as delineated above and
`optionally as further detailed below.
`[0078] According to an aspect of some embodiments of the
`present invention there is provided a system for vascular
`
`CATHWORKS EXHIBIT 1005
`Page 14 of 31
`
`

`

`US 2014/0200867 AI
`
`Jul. 17, 2014
`
`4
`
`assessment comprising: a computer functionally connected
`to a plurality of angiographic imaging devices for capturing a
`plurality of2D images of a portion of vasculature of a subject,
`configured to: accept data from the plurality of angiographic
`imaging devices; and process the images to produce a tree
`model of the vasculature, wherein the tree model comprises
`geometric measurements of the vasculature at one or more
`locations along a vessel of at least one branch of the vascu(cid:173)
`lature.
`[0079] According to some embodiments of the invention
`the system comprises a synchronization unit configured to
`provide the plurality of angiographic imaging devices with a
`synchronization signal for synchronizing the capturing of the
`plurality of 2D images of the vasculature.
`[0080] According to some embodiments of the invention
`the computer is configured to accept a subject ECG signal,
`and to select, based on the ECG signal, 2D images corre(cid:173)
`sponding to substantially a same phase during a heart beat
`cycle.
`[0081] According to some embodiments of the invention
`the system comprises an image registration unit configured
`for: detecting corresponding image features in each of N
`angiographic images, where N is an integer greater than 1;
`calculating image correction parameters based on the corre(cid:173)
`sponding image features; and based on the correction param(cid:173)
`eters, registering N-1 angiographic images to geometrically
`correspond to an angiographic image other than the N-1
`angiographic images.
`[0082] According to some embodiments of the invention
`the computer is configured for defining a surface correspond(cid:173)
`ing to a shape of the heart of the subject, and using the surface
`as a constraint for the detection of the corresponding image
`features.
`[0083] According to some embodiments of the invention
`the computer is configured for compensating for breath and
`patient movement.
`[0084] According to some embodiments of the invention
`the compensating comprises iteratively repeating the detec(cid:173)
`tion of the corresponding image features each time for a
`different subset of angiographic images, and updating the
`image correction parameters responsively to the repeated
`detection of the corresponding image features.
`[0085] According to some embodiments of the invention N
`is greater than 2. According to some embodiments of the
`invention N is greater than 3.
`[0086] According to some embodiments of the invention
`the corresponding image features comprise at least one of a
`group consisting of an origin of the tree model, a location of
`minimal radius in a stenosed vessel, and a bifurcation of a
`vessel.
`[0087] According to some embodiments of the invention
`the tree model comprises data pertaining to location, orienta(cid:173)
`tion and diameter of vessels at a plurality of points within the
`portion of the vasculature.
`[0088] According to some embodiments of the invention
`tree model comprising measurements of the vasculature at
`one or more locations along at least one branch of the vascu(cid:173)
`lature
`[0089] According to some embodiments of the invention
`the geometric measurements of the vasculature are at one or
`more locations along a centerline of at least one branch of the
`vasculature.
`
`[0090] According to some embodiments of the invention
`the tree model comprises data pertaining to blood flow char(cid:173)
`acteristics in at one or more of the plurality of points.
`[0091] According to some embodiments of the invention
`the portion of the vasculature comprises the heart arteries.
`[0092] According to an aspect of some embodiments of the
`present invention there is provided a method for vascular
`assessment comprising: receiving a plurality of 2D angio(cid:173)
`graphic images of a portion of a vasculature of a subject, and
`processing the images to produce a stenotic model over the
`vasculature, the stenotic model having measurements of the
`vasculature at one or more locations along vessels of the
`vasculature; obtaining a flow characteristic of the stenotic
`model; and calculating an index indicative of vascular func(cid:173)
`tion, based, at least in part, on the flow characteristic in the
`stenotic model.
`[0093] According to some embodiments of the invention
`the flow characteristic of the stenotic model comprises resis(cid:173)
`tance to fluid flow.
`[0094] According to some embodiments of the invention
`the invention the method comprises identifying in the first
`stenotic model a stenosed vessel and a crown of the stenosed
`vessel, and calculating the resistance to fluid flow in the
`crown; wherein the index is calculated based on a volume of
`the crown, and on a contribution of the stenosed vessel to the
`resistance to fluid flow.
`[0095] According to some embodiments of the invention
`the flow characteristic of the stenotic model comprises fluid
`flow.
`[0096] According to some embodiments of the invention
`the stenotic model is a three-dimensional vessel tree.
`[0097] According to some embodiments of the invention
`the vessel tree comprises data pertaining to location, orienta(cid:173)
`tion and diameter of vessels at a plurality of points within the
`portion of the vasculature.
`[0098] According to some embodiments of the invention
`the processing comprises: extending the stenotic model by
`one bifurcation; calculating a new flow characteristic in the
`extended stenotic model; updating the index responsively to
`the new flow characteristic and according to a predetermined
`criterion; and iteratively repeating the extending, the calcu(cid:173)
`lating and the updating.
`[0099] According to some embodiments of the invention
`the method comprises processing the images to produce a
`second model over the vasculature, and obtaining a flow
`characteristic of the second model; wherein the calculation of
`the index is based on the flow characteristic in the stenotic
`model and on the flow characteristic in the second model.
`[0100] According to some embodiments of the invention
`the method the second model is a normal

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket