IP Library Granted Patent US 12,507,900
Granted Patent B2
US 12,507,900 · App. 17/595,433 · Granted Dec 30, 2025

Pressure based structural heart assessment systems and methods

Inventors: Sébastien Lalancette (Quebec City, CA); Thomas Goodhart (Calgery, CA); Maxime Picard Deland (Quebec City, CA); Claude Belleville (Quebec City, CA)
Assignee: Opsens, Inc.
A61B5/02156A61B5/02158A61B5/6851A61F2/2427A61B2505/05
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Quick Facts
Patent No.
US 12,507,900
App. No.
17/595,433
Granted
Dec 30, 2025
Kind
B2
Abstract

The heart valve assessment systems described herein advantageously provide indicators of a heart valve condition, such as a pressure gradient or a valve regurgitation index. The heart valve assessment systems can provide indicators of a heart valve condition during a heart procedure. A pressure gradient indicates a severity or measurement of the narrowing (or stenosis) of a valve by the increase in pressure behind it. A valve regurgitation index indicates a leakiness measurement of a valve.

Claims (79)

1 . A system comprising:

a pressure guidewire comprising:

an outer tube,

a core wire, and

a first pressure sensor, wherein the first pressure sensor is positioned radially between a reduced diameter portion of the core wire and a coil portion of the outer tube;

a second pressure sensing device comprising a second pressure sensor;

a non-transitory computer storage medium configured to at least store computer-executable instructions; and

one or more hardware processors in communication with the non-transitory computer storage medium, the one or more hardware processors configured to execute the computer-executable instructions to at least:

calibrate the second pressure sensor relative to the first pressure sensor while (i) the first pressure sensor is positioned in a first portion of a heart and (ii) the second pressure sensor is positioned in a cardiovascular region adjacent to the first portion of the heart, wherein to calibrate the second pressure sensor relative to the first pressure sensor further comprises:

determine a first plurality of pressure values from the first pressure sensor positioned in the first portion of the heart;

determine a second plurality of pressure values from the second pressure sensor in the cardiovascular region adjacent to the first portion of the heart;

detect a dicrotic notch feature in the first plurality of pressure values;

identify a timestamp corresponding to the dicrotic notch feature;

determine, from the first plurality of pressure values, a first value at the timestamp;

determine, from the second plurality of pressure values, a second value at the timestamp; and

determine a gain adjustment based at least in part on the first value and the second value;

determine a third plurality of pressure values from the first pressure sensor positioned in the first portion of the heart;

determine a fourth plurality of pressure values from the second pressure sensor positioned in the cardiovascular region adjacent to the first portion of the heart, wherein to determine the fourth plurality of pressure values further comprises:

apply the gain adjustment to an initial plurality of pressure values from the second pressure sensor;

detect a first feature in the third plurality of pressure values;

detect a second feature in the fourth plurality of pressure values;

determine a heart valve condition based at least in part on the first feature and the second feature; and

display the heart valve condition on a user interface.

2 . The system of claim 1 , wherein to calibrate the second pressure sensor relative to the first pressure sensor further comprises:

a detect a value at a substantially beginning of a systolic phase in the first plurality of pressure values;

determine a time adjustment to the second plurality of pressure values such that a value from the second plurality of pressure values corresponds to the value at the substantially beginning of the systolic phase in the first plurality of pressure values, wherein to apply the gain adjustment further comprises:

apply the time adjustment and the gain adjustment to the initial plurality of pressure values.

3 . The system of claim 1 , wherein to identify the timestamp corresponding to the dicrotic notch feature further comprises:

identify the timestamp within a percentage of a heartbeat period before or after the dicrotic notch feature in the first plurality of pressure values.

4 . The system of claim 1 , wherein the first value corresponds to V 1 , the second value corresponds to V 2 , the gain adjustment comprises g, and wherein to determine the gain adjustment further comprises a determining relationship substantially as:

g=V 1 /V 2 .

5 . The system of claim 1 , wherein the first feature comprises at least one of a systolic phase or a diastolic phase in the third plurality of pressure values.

6 . A system comprising:

a pressure guidewire comprising:

an outer tube,

a connector tube positioned radially inward of the outer tube,

a core wire positioned radially inward of the outer tube, and

a pressure sensor assembly comprising a first pressure sensor and a pressure wire lead extending from the first pressure sensor toward a proximal end of the pressure guidewire, the first pressure sensor being distal of a distal end of the connector tube;

a second pressure sensing device comprising a second pressure sensor; and

one or more hardware processors configured to at least:

calibrate one of the first pressure sensor or the second pressure sensor relative to the other one of the first pressure sensor or the second pressure sensor while (i) the first pressure sensor is positioned in a first portion of a heart and (ii) the second pressure sensor is positioned in a cardiovascular region adjacent to the first portion of the heart, wherein to calibrate the second pressure sensor relative to the first pressure sensor further comprises:

determine a first plurality of pressure values from one of the first pressure sensor or the second pressure sensor;

determine a second plurality of pressure values from the other one of the first pressure sensor or the second pressure sensor;

detect a first dicrotic notch feature in the first plurality of pressure values;

identify a timestamp corresponding to the dicrotic notch feature;

determine, from the first plurality of pressure values, a first value at the timestamp;

determine, from the second plurality of pressure values, a second value at the timestamp; and

determine a gain adjustment based at least in part on the first value and the second value;

determine a third plurality of pressure values from one of the first pressure sensor or the second pressure sensor;

determine a fourth plurality of pressure values from the other one of the first pressure sensor or the second pressure sensor, wherein to determine the fourth plurality of pressure values further comprises:

apply the gain adjustment to an initial plurality of pressure values from the other one of the first pressure sensor or the second pressure sensor;

detect a first feature in the third plurality of pressure values;

detect a second feature in the fourth plurality of pressure values;

determine a heart valve condition based at least in part on the first feature and the second feature; and

display the heart valve condition on a user interface.

7 . The system of claim 6 , wherein to calibrate one of the first pressure sensor or the second pressure sensor further comprises:

detect a value at a substantially beginning of a systolic phase in the first plurality of pressure values;

determine a time adjustment to the second plurality of pressure values such that a value from the second plurality of pressure values corresponds to the value at the substantially beginning of the systolic phase in the first plurality of pressure values, wherein to apply the gain adjustment further comprises:

apply the time adjustment and the gain adjustment to the initial plurality of pressure values.

8 . The system of claim 6 , wherein to identify the timestamp corresponding to the first dicrotic notch feature further comprises:

identify the timestamp within a percentage of a heartbeat period before or after the first dicrotic notch feature in the first plurality of pressure values.

9 . The system of claim 6 , wherein the first value corresponds to V 1 , the second value corresponds to V 2 , the gain adjustment comprises g, and wherein to determine the gain adjustment further comprises a determining relationship substantially as:

g=V 1 /V 2 .

10 . The system of claim 6 , wherein the first feature comprises at least one of a systolic phase or a first diastolic phase in the third plurality of pressure values.

11 . The system of claim 6 , wherein to detect the first dicrotic notch feature further comprises:

calculate a plurality of second derivative values from the first plurality of pressure values; and

identify a point of zero crossing based at least in part on the plurality of second derivative values, wherein the point of zero crossing corresponds to the first dicrotic notch feature.

12 . The system of claim 6 , wherein to detect the first dicrotic notch feature further comprises:

calculate, from the first plurality of pressure values, a first angle for a first point based at least in part on a first preceding point and a first following point;

calculate, from the first plurality of pressure values, a second angle for a second point based at least in part on a second preceding point and a second following point;

determine that the second angle is less than the first angle; and

identify the second point as the first dicrotic notch feature.

13 . The system of claim 6 , wherein the first feature comprises at least one of a systolic phase or a diastolic phase in the third plurality of pressure values, wherein to detect the at least one of the systolic phase or the diastolic phase further comprises:

identify a first subset of rising pressure values from the third plurality of pressure values;

identify a local minimum pressure value from the third plurality of pressure values;

determine a tangent from the first subset;

identify a horizontal line intersecting the local minimum pressure value;

identify a first intersection between the tangent and the horizontal line; and

identify a first point from the third plurality of pressure values as an end of the diastolic phase or a beginning of the first systolic phase based at least in part on the first intersection.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 2, 2024
From: LALANCETTE, SÉBASTIEN; GOODHART, THOMAS; DELAND, MAXIME PICARD; BELLEVILLE, CLAUDE
To: OPSENS, INC.
Reel/Frame 068776/0452 →
Continuity (4)
Provisional Application 62849806 · May 17, 2019
Provisional Application 62849798 · May 17, 2019
Provisional Application 62849768 · May 17, 2019
Related Publication 20220361762A1 · Nov 17, 2022
References Cited (171)
US 4678904A · Saaski et al. · 1987 [cited by applicant]
US 5385053A · Wlodarczyk et al. · 1995 [cited by applicant]
US 5406952A · Barnes et al. · 1995 [cited by applicant]
US 6004275A · Billiet · 1999 [cited by applicant]
US D420340S · Baller · 2000 [cited by applicant]
US D441761S · Machida et al. · 2001 [cited by applicant]
US 6354999B1 · Dgany et al. · 2002 [cited by applicant]
US 6394958B1 · Bratteli et al. · 2002 [cited by applicant]
US 6471656B1 · Shalman et al. · 2002 [cited by applicant]
US 6565514B2 · Svanerudh et al. · 2003 [cited by applicant]
US 7759633B2 · Duplain et al. · 2010 [cited by applicant]
US D644240S · Arnold · 2011 [cited by applicant]
US D652048S · Joseph · 2012 [cited by applicant]
US D674401S · Trumble et al. · 2013 [cited by applicant]
US D674812S · Joseph · 2013 [cited by applicant]
US D677274S · Phelan · 2013 [cited by applicant]
US D678302S · Trumble et al. · 2013 [cited by applicant]
US D682846S · Cojuangco et al. · 2013 [cited by applicant]
US D685391S · Blissenbach · 2013 [cited by applicant]
US D694252S · Helm · 2013 [cited by applicant]
US D694253S · Helm · 2013 [cited by applicant]
US D713854S · Cojuangco et al. · 2014 [cited by applicant]
US D714327S · Wood · 2014 [cited by applicant]
US D716820S · Wood · 2014 [cited by applicant]
US D717328S · Lin · 2014 [cited by applicant]
US D733727S · Cojuangco et al. · 2015 [cited by applicant]
US D753173S · Cojuangco et al. · 2016 [cited by applicant]
US 9339348B2 · Davies et al. · 2016 [cited by applicant]
US 9364153B2 · Merritt et al. · 2016 [cited by applicant]
US D763284S · Edman · 2016 [cited by applicant]
US D773478S · Wesley et al. · 2016 [cited by applicant]
US D775650S · Zhao et al. · 2017 [cited by applicant]
US D786921S · Akana et al. · 2017 [cited by applicant]
US D800757S · Mullen · 2017 [cited by applicant]
US D802001S · Javed et al. · 2017 [cited by applicant]
US 9820660B2 · Ryan et al. · 2017 [cited by applicant]
US D808982S · Kavanagh et al. · 2018 [cited by applicant]
US 9855020B2 · Nair et al. · 2018 [cited by applicant]
US 9901260B2 · Manstrom et al. · 2018 [cited by applicant]
US 9924903B2 · Burkett · 2018 [cited by applicant]
US 9974443B2 · Merritt et al. · 2018 [cited by applicant]
US 10076301B2 · Millett et al. · 2018 [cited by applicant]
US 10098702B2 · Merritt et al. · 2018 [cited by applicant]
US 10130310B2 · Alpert et al. · 2018 [cited by applicant]
US D837235S · Meng · 2019 [cited by applicant]
US 10195441B2 · Kaiser et al. · 2019 [cited by applicant]
US 10226189B2 · Davies et al. · 2019 [cited by applicant]
US D844651S · Edman · 2019 [cited by applicant]
US 10327695B2 · Anderson · 2019 [cited by applicant]
US 10363017B2 · Strommer · 2019 [cited by applicant]
US 10409951B2 · Mansker et al. · 2019 [cited by applicant]
US D864221S · Paulina et al. · 2019 [cited by applicant]
US 10453561B2 · Balignasay et al. · 2019 [cited by applicant]
US 10456051B2 · Corl et al. · 2019 [cited by applicant]
US 10552958B2 · Hansis et al. · 2020 [cited by applicant]
US 10568585B2 · Anderson et al. · 2020 [cited by applicant]
US 10638939B2 · Collins et al. · 2020 [cited by applicant]
US 10642953B2 · Cheline et al. · 2020 [cited by applicant]
US 10660769B2 · Keller · 2020 [cited by applicant]
US D887420S · Koehler et al. · 2020 [cited by applicant]
US 10667775B2 · Anderson et al. · 2020 [cited by applicant]
US 10694955B2 · Haase et al. · 2020 [cited by applicant]
US D890787S · Wenning · 2020 [cited by applicant]
US 10751015B2 · Anderson et al. · 2020 [cited by applicant]
US D899440S · Schifano et al. · 2020 [cited by applicant]
US D921003S · Lalancette et al. · 2021 [cited by applicant]
US D921648S · Lalancette et al. · 2021 [cited by applicant]
US D924910S · Laumann et al. · 2021 [cited by applicant]
US D926199S · Lalancette et al. · 2021 [cited by applicant]
US D926802S · Lee et al. · 2021 [cited by applicant]
US D934884S · Bergenstal et al. · 2021 [cited by applicant]
US D936690S · Griffin et al. · 2021 [cited by applicant]
US D937876S · Harvey · 2021 [cited by applicant]
US D937877S · Harvey · 2021 [cited by applicant]
US D939540S · Mullen et al. · 2021 [cited by applicant]
US D948542S · Yuan et al. · 2022 [cited by applicant]
US 11323434B1 · Vali et al. · 2022 [cited by applicant]
US D956786S · Yang · 2022 [cited by applicant]
US D990508S · Martinez Galan et al. · 2023 [cited by applicant]
US D1018557S · Lalancette et al. · 2024 [cited by applicant]
US 20030032986A1 · Kupper · 2003 [cited by applicant]
US 20030191400A1 · Shalman et al. · 2003 [cited by applicant]
US 20100312125A1 · Zhang · 2010 [cited by applicant]
US 20110257697A1 · Jarverud · 2011 [cited by applicant]
US 20130345574A1 · Davies et al. · 2013 [cited by applicant]
US 20140018687A1 · Mano · 2014 [cited by applicant]
US 20140135633A1 · Anderson et al. · 2014 [cited by applicant]
US 20140282256A1 · Fish et al. · 2014 [cited by applicant]
US 20150077502A1 · Jordan et al. · 2015 [cited by applicant]
US 20150105673A1 · Gregorich · 2015 [cited by applicant]
US 20150112210A1 · Webler · 2015 [cited by applicant]
US 20150119705A1 · Tochterman et al. · 2015 [cited by applicant]
US 20150223707A1 · Ludoph · 2015 [cited by applicant]
US 20150230713A1 · Merritt et al. · 2015 [cited by applicant]
US 20160000341A1 · Rotman et al. · 2016 [cited by applicant]
US 20160022159A1 · Caron et al. · 2016 [cited by applicant]
US 20160058307A1 · Svanerudh · 2016 [cited by applicant]
US 20160128583A1 · Caron et al. · 2016 [cited by applicant]
US 20160206214A1 · Davies et al. · 2016 [cited by applicant]
US 20160228013A1 · Al-Jilaihawi et al. · 2016 [cited by applicant]
US 20160310026A1 · Moen et al. · 2016 [cited by applicant]
US 20160346449A1 · Roche et al. · 2016 [cited by applicant]
US 20170027458A1 · Glover et al. · 2017 [cited by applicant]
US 20170071486A1 · Belleville et al. · 2017 [cited by applicant]
US 20170242935A1 · Wragg et al. · 2017 [cited by applicant]
US 20170322416A1 · Oserhout · 2017 [cited by applicant]
US 20180020929A1 · Gregorich · 2018 [cited by applicant]
US 20180042555A1 · Braido et al. · 2018 [cited by applicant]
US 20180103854A1 · Manstrom et al. · 2018 [cited by applicant]
US 20180116751A1 · Schwartz et al. · 2018 [cited by applicant]
US 20180228387A1 · Park et al. · 2018 [cited by applicant]
US 20180280088A1 · Davies · 2018 [cited by applicant]
US 20190038144A1 · Li · 2019 [cited by applicant]
US 20190053717A1 · Gu et al. · 2019 [cited by applicant]
US 20190069783A1 · Bullens et al. · 2019 [cited by applicant]
US 20190082978A1 · van der Horst et al. · 2019 [cited by applicant]
US 20190265802A1 · Parshionikar · 2019 [cited by applicant]
US 20190269335A1 · Groenland et al. · 2019 [cited by applicant]
US 20190274565A1 · Soli et al. · 2019 [cited by applicant]
US 20190320913A1 · Li · 2019 [cited by applicant]
US 20200022604A1 · Scabellone et al. · 2020 [cited by applicant]
US 20200035472A1 · Richardson et al. · 2020 [cited by applicant]
US 20200043608A1 · Kuo et al. · 2020 [cited by applicant]
US 20200178816A1 · Lantelm · 2020 [cited by examiner]
US 20200289078A1 · Haase et al. · 2020 [cited by applicant]
US 20200363939A1 · Fitzgerald · 2020 [cited by applicant]
US 20210093208A1 · Tochterman et al. · 2021 [cited by applicant]
US 20210100462A1 · Belleville et al. · 2021 [cited by applicant]
CA 3021877 · 2018 [cited by applicant]
EP 2744401 · 2016 [cited by applicant]
JP 2015501184 · 2015 [cited by applicant]
JP 2017504415 · 2017 [cited by applicant]
JP 2018531645 · 2018 [cited by applicant]
JP 2018536454 · 2018 [cited by applicant]
WO WO1999034724 · 1999 [cited by applicant]
WO WO1999056612 · 1999 [cited by applicant]
WO WO2000035342 · 2000 [cited by applicant]
WO WO2000039275 · 2000 [cited by applicant]
WO WO2000053081 · 2000 [cited by applicant]
WO WO2000055579 · 2000 [cited by applicant]
WO WO2001013779 · 2001 [cited by applicant]
WO WO2001021057 · 2001 [cited by applicant]
WO WO2002032300 · 2002 [cited by applicant]
WO WO2002100238 · 2002 [cited by applicant]
WO WO2003022122 · 2003 [cited by applicant]
WO WO2004019778 · 2004 [cited by applicant]
WO WO2013028612 · 2013 [cited by applicant]
WO WO2013028613 · 2013 [cited by applicant]
WO WO2015109339 · 2015 [cited by applicant]
WO WO2017013020 · 2017 [cited by applicant]
WO WO2017087642A1 · 2017 [cited by applicant]
WO WO2020148162 · 2020 [cited by applicant]
WO WO2020236494 · 2020 [cited by applicant]
WO WO2023183260 · 2023 [cited by applicant]
510(k) Summary, Florence Medical Ltd., SmartFlowTM, 510(k( No. K012947, Oct. 2, 2001. [cited by applicant]
510(k) Summary, Florence Medical Ltd., SmartFlow®, 510(k( No. K020127, Feb. 14, 2002. [cited by applicant]
Patel et al., “Hemodynamic Assessment of Aortic/Mitral Stenosis and Regurgitation”, Practical Manual of Interventional Cardiology, Oct. 27, 2014, (Retrieved from the Internet Nov. 3, 2020). Internet URL: <https://link.s… [cited by applicant]
Pijls, “Coronary Physiology In The Cathlab: Theory and Practical Set-up of FFR”, Educational Training Program ESC, European Heart House, Apr. 24-26, 2014, in 150 pages. [cited by applicant]
Pijls et al., “Coronary Pressure Measurement to Assess the Hemodynamic Significance of Serial Stenoses Within One Coronary Artery”, Circulation, Nov. 7, 2000, vol. 120, pp. 2371-2377. [cited by applicant]
Radianalyzer, Instrument for Physiological Assessment, Instructions for Use, 2004, in 39 pages. [cited by applicant]
Radianalyzerxpress, Interface for Physiological Assessment, Instructions for Use, 2004, in 46 pages. [cited by applicant]
Shalman et al., “Numerical modeling of the flow in stenosed coronary artery. The relationship between main hemodynamic parameters”, Computers in Biology and Medicine, 2002, vol. 32, pp. 329-344. [cited by applicant]
Smartflowtm, Intergrated Lumen Physiology for the Cathlab, Smartflow CFR/FFRTM, Model 2000, Version 5.0, CFR/FFR, 2001. [cited by applicant]
Smartflowtm, Intergrated Lumen Physiology, Version 5.0, Operator's Manual, Apr. 2001, in 42 pages. [cited by applicant]
Ballinger, “What do normal and abnormal heart rhythms look like on Apple Watch?”, Cardiogram, published May 31, 2016 (Retrieved from the internet Mar. 3, 2021. Internet URL: <https://blog.cardiogr.am/what-do-normal-and-… [cited by applicant]
“BitScope Chart Recorder”, BitScope, Published Jul. 18, 2018 (Retrieved from the Internet Jul. 20, 2023. Internet URL: ,https://web.archive.org/web/20180718231406/https://bitscope.com/softwarechart/> (Year: 2018). [cited by applicant]
Mylotte et al., “Paravalvular aortic regurgitation after TAVI: new insight”, Europa Digital & Publishing, 2015, pp. 371-372. [cited by applicant]
Stundl et al., “Early versus newer generation transcatheter heart valves for transcatheter aortic valve implantation: Echocardiographic and hemodynamic evaluation of an all-comers study cohort using the dimensionless ao… [cited by applicant]
Valsalva Wave. Coherent Breathing Biofeedback, published Jun. 2016 (Retrieved from the Internet Mar. 3, 2021). Internet URL:<https ://coherentbreathingbiofeedback.com/valsalvawave .html> (Year: 2016). [cited by applicant]
Van Wely et al., “Aortic Regurgitation Index Ratio Is a Strong Predictor of 1-Year Mortality After Transcatheter Aortic Valve Implantation Using Self-Expanding Devices”, Semin Thoracic Surg., 2020, vol. 33, pp. 923-930. [cited by applicant]
International Search Report and Written Opinion issued in PCT Application No. PCT/US2020/032748, dated Sep. 24, 2020, in 23 pages. [cited by applicant]