Granted Patent
B2
US 12,551,339 · App. 18/456,708 · Granted Feb 17, 2026
Expandable implantable conduit
Inventors:
C. Douglas Bernstein (Pittsburgh, PA); Arush Kalra (Pittsburgh, PA); Denver Faulk (North Huntington, PA)
Assignee:
PECA Labs, Inc.
A61F2/2418A61F2/06A61F2/07A61F2/2433A61F2/2475A61F2210/0071A61F2230/0069A61F2240/002A61F2250/001A61F2250/0082A61F2250/0097A61F2250/0098
View Patent ↗
Loading inventors, assignments & file history…
Abstract
Implantable devices including conduits that have markings along the length of the conduit are described herein.
Claims (18)
1 . An implantable device comprising:
a plastically deformable conduit comprising a continuous sheet of a biocompatible polymer, the plastically deformable conduit having an outer surface having a length; and
wherein the plastically deformable conduit has a plurality of dashed radiopaque circumferential markings spaced along the length of the outer surface;
wherein the plastically deformable conduit has a plurality of dashed radiopaque longitudinal markings spaced along the length of the outer surface;
wherein the plastically deformable conduit is configured to be expanded from a pre-expansion state having a pre-expansion inner diameter to a post-expansion state having a post-expansion inner diameter;
wherein the plastically deformable conduit has a yield strength of about 0.1 MPa to about 4 MPa; and
wherein the plastically deformable conduit has an internode distance of about 10 μm to about 40 μm.
2 . The implantable device of claim 1 , further comprising an additional component disposed within the plastically deformable conduit.
3 . The implantable device of claim 1 , further comprising an additional component disposed over the outer surface of the plastically deformable conduit.
4 . The implantable device of claim 1 , further comprising an additional component comprising one or more anticoagulants.
5 . The implantable device of claim 4 , wherein the one or more anticoagulants are selected from the group consisting of coumadin, heparin, a heparin derivative, a Factor Xa inhibitor, a direct thrombin inhibitor, hementin, sintered porous titanium microspheres, and a combination thereof.
6 . The implantable device of claim 1 , further comprising a stent.
7 . The implantable device of claim 1 , further comprising one or more letters on the outer surface of the plastically deformable conduit, one or more numbers on the outer surface of the plastically deformable conduit, or a combination thereof.
8 . The implantable device of claim 7 , wherein the one or more letters and the one or more numbers are individually radiopaque.
9 . The implantable device of claim 7 , wherein the one or more letters and the one or more numbers are visible.
10 . The implantable device of claim 1 , wherein at least one of the plurality of circumferential markings and the plurality of longitudinal markings display conduit length, conduit orientation, conduit diameter, or a combination thereof.
11 . The implantable device of claim 1 , wherein the biocompatible polymer comprises a fluoropolymer.
12 . The implantable device of claim 1 , wherein the plastically deformable conduit further comprises a valve.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Sep 6, 2023
From: BERNSTEIN, C. DOUGLAS; FAULK, DENVER; KALRA, ARUSH
To: PECA LABS, INC.
Reel/Frame 064818/0142 →
Continuity (4)
Provisional Application
62302595
· Mar 2, 2016
References Cited (256)
US 4187390A
· Gore
· 1980
[cited by applicant]
US 4425670A
· Figuera
· 1984
[cited by applicant]
US 4475972A
· Wong
· 1984
[cited by applicant]
US 4610688A
· Silvestrini et al.
· 1986
[cited by applicant]
US 4676789A
· Sorensen et al.
· 1987
[cited by applicant]
US 4816339A
· Tu et al.
· 1989
[cited by applicant]
US 4902289A
· Yannas
· 1990
[cited by applicant]
US 4955899A
· Della Corna et al.
· 1990
[cited by applicant]
US 5123918A
· Perrier et al.
· 1992
[cited by applicant]
US 5314467A
· Shu
· 1994
[cited by applicant]
US 5443499A
· Schmitt
· 1995
[cited by examiner]
US 5466261A
· Richelsoph
· 1995
[cited by applicant]
US 5469868A
· Reger
· 1995
[cited by applicant]
US 5607478A
· Lentz et al.
· 1997
[cited by applicant]
US 5628791A
· Bokros et al.
· 1997
[cited by applicant]
US 5772694A
· Bokros et al.
· 1998
[cited by applicant]
US 5800512A
· Lentz et al.
· 1998
[cited by applicant]
US 5804011A
· Dutta et al.
· 1998
[cited by applicant]
US 5814099A
· Bicer
· 1998
[cited by applicant]
US 5824050A
· Karwoski et al.
· 1998
[cited by applicant]
US 5843161A
· Solovay
· 1998
[cited by applicant]
US 5861029A
· Evdokimov et al.
· 1999
[cited by applicant]
US 5908451A
· Yeo
· 1999
[cited by applicant]
US 5919226A
· Shu et al.
· 1999
[cited by applicant]
US 6016848A
· Egres, Jr.
· 2000
[cited by applicant]
US 6039755A
· Edwin
· 2000
[cited by examiner]
US 6051022A
· Cai et al.
· 2000
[cited by applicant]
US 6053943A
· Edwin
· 2000
[cited by examiner]
US 6059810A
· Brown et al.
· 2000
[cited by applicant]
US 6168619B1
· Dinh et al.
· 2001
[cited by applicant]
US 6176875B1
· Lenker
· 2001
[cited by examiner]
US 6187054B1
· Colone et al.
· 2001
[cited by applicant]
US 6203568B1
· Lombardi
· 2001
[cited by examiner]
US 6241762B1
· Shanley
· 2001
[cited by applicant]
US 6245100B1
· Davila
· 2001
[cited by examiner]
US 6395024B1
· Lapeyre et al.
· 2002
[cited by applicant]
US 6436135B1
· Goldfarb
· 2002
[cited by applicant]
US 6517571B1
· Brauker et al.
· 2003
[cited by applicant]
US 6716239B2
· Sowinski et al.
· 2004
[cited by applicant]
US 6730118B2
· Spenser et al.
· 2004
[cited by applicant]
US 6830585B1
· Artof et al.
· 2004
[cited by applicant]
US 6863686B2
· Shannon et al.
· 2005
[cited by applicant]
US 6890350B1
· Walak
· 2005
[cited by examiner]
US 6936066B2
· Palmaz
· 2005
[cited by examiner]
US 6939372B2
· Dong
· 2005
[cited by applicant]
US 6976952B1
· Maini et al.
· 2005
[cited by applicant]
US 7153324B2
· Case et al.
· 2006
[cited by applicant]
US 7153325B2
· Kim et al.
· 2006
[cited by applicant]
US 7306729B2
· Bacino et al.
· 2007
[cited by applicant]
US 7648527B2
· Agnew
· 2010
[cited by applicant]
US 7789908B2
· Sowinski et al.
· 2010
[cited by applicant]
US 8025693B2
· Quigley
· 2011
[cited by examiner]
US 8211165B1
· McIntosh et al.
· 2012
[cited by applicant]
US 8226710B2
· Nguyen et al.
· 2012
[cited by applicant]
US 8672997B2
· Drasler et al.
· 2014
[cited by applicant]
US 8900652B1
· Caballero et al.
· 2014
[cited by applicant]
US 8956398B2
· George
· 2015
[cited by examiner]
US 9289289B2
· Rolando et al.
· 2016
[cited by applicant]
US 9585746B2
· Yoshida et al.
· 2017
[cited by applicant]
US 9918833B2
· Kovalsky et al.
· 2018
[cited by applicant]
US 20010039446A1
· Edwin
· 2001
[cited by examiner]
US 20010049555A1
· Gabbay
· 2001
[cited by applicant]
US 20020055775A1
· Carpentier et al.
· 2002
[cited by applicant]
US 20020133226A1
· Marquez et al.
· 2002
[cited by applicant]
US 20020138135A1
· Duerig et al.
· 2002
[cited by applicant]
US 20030027332A1
· Lafrance et al.
· 2003
[cited by applicant]
US 20030114917A1
· Holloway et al.
· 2003
[cited by applicant]
US 20030114924A1
· Moe
· 2003
[cited by applicant]
US 20030191525A1
· Thornton
· 2003
[cited by applicant]
US 20040225356A1
· Frater
· 2004
[cited by applicant]
US 20050075727A1
· Wheatley
· 2005
[cited by applicant]
US 20050228495A1
· Macoviak
· 2005
[cited by applicant]
US 20060122693A1
· Biadillah et al.
· 2006
[cited by applicant]
US 20060149366A1
· Henderson
· 2006
[cited by applicant]
US 20060161248A1
· Case et al.
· 2006
[cited by applicant]
US 20060178748A1
· Dinger et al.
· 2006
[cited by applicant]
US 20060241745A1
· Solem
· 2006
[cited by applicant]
US 20060282173A1
· McFetridge
· 2006
[cited by applicant]
US 20070027528A1
· Agnew
· 2007
[cited by applicant]
US 20070038295A1
· Case
· 2007
[cited by examiner]
US 20070043431A1
· Melsheimer
· 2007
[cited by applicant]
US 20080200976A1
· Asgari
· 2008
[cited by applicant]
US 20090105810A1
· Jaffe
· 2009
[cited by applicant]
US 20090118826A1
· Khaghani
· 2009
[cited by applicant]
US 20100023114A1
· Chambers et al.
· 2010
[cited by applicant]
US 20100204775A1
· Edwin
· 2010
[cited by applicant]
US 20100312333A1
· Navia et al.
· 2010
[cited by applicant]
US 20110094592A1
· Cheng et al.
· 2011
[cited by applicant]
US 20110125163A1
· Rutten et al.
· 2011
[cited by applicant]
US 20120290082A1
· Quint et al.
· 2012
[cited by applicant]
US 20130166016A1
· Cully et al.
· 2013
[cited by applicant]
US 20130304196A1
· Kelly
· 2013
[cited by applicant]
US 20140163671A1
· Bruchman et al.
· 2014
[cited by applicant]
US 20140288632A1
· Soletti et al.
· 2014
[cited by applicant]
US 20140330372A1
· Weston et al.
· 2014
[cited by applicant]
US 20180147044A1
· Tsuchikura et al.
· 2018
[cited by applicant]
US 20180168795A1
· Bernstein et al.
· 2018
[cited by applicant]
US 20190216605A1
· Bernstein et al.
· 2019
[cited by applicant]
US 20200268509A1
· Bernstein et al.
· 2020
[cited by applicant]
US 20200268510A1
· Bernstein et al.
· 2020
[cited by applicant]
US 20210220129A1
· Bernstein et al.
· 2021
[cited by applicant]
US 20230149171A1
· Bernstein et al.
· 2023
[cited by applicant]
CA 2637662A1
· 2007
[cited by applicant]
CN 1304298A
· 2001
[cited by applicant]
CN 102497836A
· 2012
[cited by applicant]
EP 1064034A1
· 2001
[cited by applicant]
JP S6446468A
· 1989
[cited by applicant]
JP 2007536951A
· 2007
[cited by applicant]
JP 2008526366A
· 2008
[cited by applicant]
JP 2011515115A
· 2011
[cited by applicant]
JP 4865730B2
· 2012
[cited by applicant]
WO 1994015548A1
· 1994
[cited by applicant]
WO 9505131A1
· 1995
[cited by applicant]
WO 9603938A1
· 1996
[cited by applicant]
WO 2004019821A1
· 2004
[cited by applicant]
WO 2005011535A2
· 2005
[cited by applicant]
WO 2009061419A1
· 2009
[cited by applicant]
WO 2009134701A2
· 2009
[cited by applicant]
WO WO2011084559A2
· 2011
[cited by examiner]
WO 2012018779A2
· 2012
[cited by applicant]
WO 2013019756A2
· 2013
[cited by applicant]
WO 2014145811A1
· 2014
[cited by applicant]
WO WO2014138599A1
· 2014
[cited by examiner]
WO 2016028591A1
· 2016
[cited by applicant]
WO 2016205773A1
· 2016
[cited by applicant]
WO 2018071417A1
· 2018
[cited by applicant]
Pashneh-Tala et al. “The Tissue-Engineered Vascular Graft-Past, Present, and Future” 2016, International Standard Tissue Engineering: Part B 22(1):68-100.
[cited by applicant]
Proptopapas et al. “Contegra Conduit for Reconstruction of the Right Ventricular Outflow Tract: a Review of Published Early and Mid-time Results” Nov. 18, 2008, J. Cardiothoracic Surgery 3(62):7 Pages.
[cited by applicant]
Rosti et al. “Mechanical Valves in the Pulmonary Position: a Reappraisal” May 1998, J. Thoracic and Cardiovascular Surgery 115(5):1074-1079.
[cited by applicant]
Sano et al. “Right Ventricle-pulmonary Artery Shunt in First-stage Palliation of Hypoplastic Left Heart Syndrome” Aug. 2003, J. Thoracic and Cardiovascular Surgery 126(2):504-509.
[cited by applicant]
Schreiber et al. “Early Graft Failure of Small-Sized Porcine-Valved Conduits in Reconstruction of Right Ventricular Outflow Tract” 2006, The Annals of Thoracic Surgery 82:179-186.
[cited by applicant]
Shebani et al. “Right Ventricular Outflow Tract Reconstruction Using Contegra.RTM. Valved Conduit: Natural History and Conduit: Performance Under Pressure” 2006, European J. Cardio-thoracic Surgery 29:397-405.
[cited by applicant]
Shiose et al. “Recent Advances and Patents on Circulatory Support Devices for Pediatric Patients” 2009, Recent Patents on Biomedical Engineering 2(3):161-164.
[cited by applicant]
Stefano et al. “Right Ventricle Outflow Tract Reconstruction in the Pediatric Population: a Comparative Analysis Between Different Grafts” Nov. 2010, The 15th Congress on Cardio-Thoracic Surgery 1Page.
[cited by applicant]
Supplementary European Search Report and Written Opinion for EP 16812600.1 mailed Jan. 15, 2019, 07 Pages.
[cited by applicant]
Teleflex Medical OEM “Balloons and Balloon Catheters” 2015, printed from https://www.teleflexmedicaloem.com/diagnostic-and-interventional-catheters/balloon-catheters (Oct. 3, 2019) 3 Pages.
[cited by applicant]
Wald et al. “Refining the Assessment of Pulmonary Regurgitation in Adults After Tetralogy of Fallot Repair: Should We Be Measuring Regurgitant Fraction or Regurgitant Volume?” Feb. 2009, J. European Heart 30:356-361.
[cited by applicant]
Wang et al. “In Vivo Degradation Characteristics of Poly(Glycerol Sebacate)” Jul. 2003, J. Biomedical Materials Research Part A 36A: 192-197.
[cited by applicant]
Yoganathan et al. “Fluid Mechanics of Heart Valves” 2004, Annual Review of Biomedical Engineering 6:331-362.
[cited by applicant]
Yoshida et al. “Midterm Results of Bicuspid Valved PTFE Conduit for Right Ventricular Outflow Tract Reconstruction” 2012, The 48th Annual Meeting, The Society of Thoracic Surgeons 19 Pages.
[cited by applicant]
Yoshida et al. “Right Ventricular Outflow Tract Reconstruction with Bicuspid Valved Polytetrafluoroethylene Conduit” 2011, Annals of Thoracic Surgery 91:1235-1239.
[cited by applicant]
Yuan et al. “Right Ventricular Outflow Tract Reconstruction: Valved Conduit of Choice and Clinical Outcomes” 2008, Journal of Cardiovascular Medicine 9(4):327-337.
[cited by applicant]
Extended European Search Report for application No. 24176940.5 dated Aug. 16, 2024.
[cited by applicant]
Ando et al. “Ten-year Experience With Handmade Trileaflet Polytetrafluoroethylene Valved Conduit Used for Pulmonary Reconstruction” Jan. 2009, The J. Thoracic and Cardiovascular Surgery 137:124-131.
[cited by applicant]
Back et al. “Biomaterials in Vascular Surgery” 1996, Human Biomaterials Applications, Humana Press Incorporated 257-299.
[cited by applicant]
Batlivala et al. “Pulmonary Valve Replacement Function in Adolescents: A Comparison of Bioprosthetic Valves and Homograft Conduits” 2012, The Annals of Thoracic Surgery 93:2007-2016.
[cited by applicant]
BD Bard “Conquest PTA Dilation Catheters” 2018, BD Bard accessed on Oct. 3, 2019, 2 pages.
[cited by applicant]
Bernstein et al. “Bicuspid-Valved PTFE Conduit Optimization for Pediatric RVOT Reconstruction” 2011, Bioengineering Conference (NEBEC) 2 Pages.
[cited by applicant]
Bianca et al. “Sex Ratio Imbalance in Transposition of the Great Arteries and Possible Agricultural Environmental Risk Factors” 2001, Images in Paediatric Cardiology 8:10-14.
[cited by applicant]
Bielefeld et al. “Reoperative Homograft Right Ventricular Outflow Tract Reconstruction” 2001, The Annals of Thoracic Surgery 71(2):482-488.
[cited by applicant]
Boethig et al. “Mid Term Course After Pediatric Right Ventricular Outflow Tract Reconstruction: a Comparison of Homografts, Porcine Xenografts and Contegras” 2005, European J. Cardio-thoracic Surgery 27:58-66.
[cited by applicant]
Boudjemline et al. “Use of Bovine Jugular Vein to Reconstruct the Right Ventricular Outflow Tract: Early Results” Aug. 2003, J. Thoracic and Cardiovascular Surgery 126(2):490-497.
[cited by applicant]
Brown et al. “Right Ventricular Outflow Tract Reconstruction With Polytetrafluoroethylene Monocusp Valve: a Twelve-year Experience” May 2007, J. Thoracic and Cardiovascular Surgery, 133(5):1336-1343.
[cited by applicant]
Caldarone et al. “Independent Factors Associated with Longevity of Prosthetic Pulmonary Valves and Valved Conduits” 2000, J Thorac Cardiovasc Surg 120:1022-1031.
[cited by applicant]
Canadian Office Action for Canadian Patent Application No. 2,855,943 dated Jul. 19, 2018.
[cited by applicant]
Canfield et al. “National Estimates and Race/Ethnic-Specific Variation of Selected Birth Defects in the United States, 1999-2001” 2006, Birth Defects Research (Part A): Clinical and Molecular Teratology 76:747-756.
[cited by applicant]
Catanese et al. “Mechanical Properties of Medical Grade Expanded Polytetrafluoroethylene: The Effect of Internodal Distance, Density, and Displacement Rate” Apr. 24, 1998, J. Biomedical Materials Research 48:187-192.
[cited by applicant]
Chrysosotomou et al., Chapter 21: Tetralogy of Fallot with Pulmonary Atresia, Critical Care of Children with Heart Disease: Basic Medical and Surgical Concepts, (2010), 213-219.
[cited by applicant]
Chrysosotomou et al., Chapter 22: Pulmonary Atresia with Intact Interventricular Septum, Critical Care of Children with Heart Disease: Basic Medical and Surgical Concepts, (2010), 221-229.
[cited by applicant]
Cruz et al. “Truncus Arteriosus” 2009, Critical Care of Children with Heart Disease, Springer Ch.35:383-398.
[cited by applicant]
Defrances et al. “National Hospital Discharge Survey: 2005 Annual Summary With Detailed Diagnosis and Procedure Data” Dec. 2007, National Center for Health Statistics, Vital and Health Statistics 13(165):218 Pages.
[cited by applicant]
Dur et al. “In Vitro Evaluation of Right Ventricular Outflow Tract Reconstruction With Bicuspid Valved Polytetrafluoroethylene Conduit” 2010, Artificial Organs 34(11):1010-1016.
[cited by applicant]
Erek et al. “Durability of Stentless Bioprostheses for Right Ventricular Outflow Tract Reconstruction” 2005, The Annals of Thoracic Surgery 79(6): 2202-2203.
[cited by applicant]
European Patent Organisation Communication Article 94(3) for 14761111.5 dated May 17, 2021, 5 Pages.
[cited by applicant]
European Search Report and Written Opinion for EP22185870.7 received Oct. 11, 2022.
[cited by applicant]
Famaey et al. “In Situ Evolution of the Mechanical Properties of Stretchable and Non-stretchable EPTFE Vascular Grafts and Adjacent Native Vessels” 2014, The International J. Artificial Organs 37(12):900-910.
[cited by applicant]
Forbess “Conduit Selection for Right Ventricular Outflow Tract Reconstruction: Contemporary Options and Outcomes” 2004, Pediatric Cardiac Surgery Annual of the Seminars in Thoracic Cardiovascular Surgery 7:115-124.
[cited by applicant]
Forbess et al. “Cryopreserved Homografts in the Pulmonary Position: Determinants of Durability” 2001, The Annals of Thoracic Surgery 71(1):54-59.
[cited by applicant]
Fung “Biodynamics-circulation” 1984, Springer-Verlag, New York-Berlin Heidelberg Tokyo 189 3 Pages.
[cited by applicant]
Gober et al. “Adverse Mid-Term Outcome Following RVOT Reconstruction Using the Contegra Valved Bovine Jugular Vein” 2005, The Annals of Thoracic Surgery 79:625-631.
[cited by applicant]
Graham et al. “Comparison of Norwood Shunt Types: Do the Outcomes Differ 6 Years Later?” 2010, The Annals of Thoracic Surgery 90:31-35.
[cited by applicant]
Hamilton et al. “Births: Preliminary Data for 2009” Dec. 21, 2010, National Vital Statistics Reports 59(3):1-19.
[cited by applicant]
Heron et al. “Deaths: Final Data for 2006” Apr. 17, 2009, National Vital Statistics Reports 57(14):1-135.
[cited by applicant]
Hoffman et al. “The Incidence of Congenital Heart Disease” Jun. 19, 2002, J. The American College of Cardiology 39(12):1890-1900.
[cited by applicant]
Hoffman, J.I.E. (2005). Congenital Heart Disease. In: Rosendorff, C. (eds) Essential Cardiology. Humana Press. https://doi.org/10.1007/978-1-59259-918-9_21.
[cited by applicant]
Hoyert et al. “Annual Summary of Vital Statistics: 2004” Jan. 2006, Pediatrics 117(1):168-183.
[cited by applicant]
International Search Report and Written Opinion for PCT/US2012/048902 dated Oct. 5, 2012, 17 Pages.
[cited by applicant]
International Search Report and Written Opinion for PCT/US2014/021814 dated Jun. 25, 2014, 10 Pages.
[cited by applicant]
International Search Report and Written Opinion for PCT/US2016/038302 dated Sep. 7, 2016, 10 Pages.
[cited by applicant]
International Search Report and Written Opinion for PCT/US2017/020421 dated May 18, 2017, 9 Pages.
[cited by applicant]
International Search Report and Written Opinion for PCT/US2017/055939 dated Feb. 5, 2018, 10 Pages.
[cited by applicant]
International Standard “Cardiovascular Implants and Extracorporeal Systems—Vascular Prostheses—Tubular Vascular Grafts and Vascular Patches 2nd Ed.” 2016, ISO 7198:1-54.
[cited by applicant]
Kaza et al. “Long-Term Results of Right Ventricular Outflow Tract Reconstruction in Neonatal Cardiac Surgery: Options and Outcomes” 2009, The J. Thoracic and Cardiovascular Surgery 138:911-916.
[cited by applicant]
Meddevice Online “Angioplasty Balloons” Accessed on Oct. 3, 2019, Source: Advanced Polymers Incorporated 1 Page.
[cited by applicant]
Menon et al. “Regional Myocardial Dysfunction following Norwood with Right Ventricle to Pulmonary Artery Conduit in Patients with Hypoplastic Left Heart Syndrome” Aug. 2011, J. American Society of Echocardiography 24(8)…
[cited by applicant]
Meyns et al. “The Contegra Conduit in the Right Ventricular Outflow Tract Induces Supravalvular Stenosis” Dec. 2004, J. Thoracic and Cardiovascular Surgery 128:834-840.
[cited by applicant]
Miyazaki et al. “Expanded Polytetrafluoroethylene Conduits and Patches With Bulging Sinuses and Fan-shaped Valves in Right Ventricular Outflow Tract Reconstruction: Multicenter Study in Japan” Nov. 2011, J. Thoracic and…
[cited by applicant]
Naheed et al. “Pulmonary Atresia with Intact Ventricular Septum” 2011, Heart Diseases in Children: A Pediatricians Guide Ch. 16:195-202.
[cited by applicant]
Niwa et al. “Progressive Aortic Root Dilatation in Adults and Late After Repair of Tetralogy of Fallot” Sep. 10, 2002, Circulation, J. the American Heart Association 106:1374-1378.
[cited by applicant]
Nordson Medical, “Medical Balloon Types and Specifications” 2018, (Accessed Oct. 3, 2019).
[cited by applicant]
Ohye et al. “Comparison of Right Ventricle to Pulmonary Artery Conduit and Modified Blalock-taussig Shunt Hemodynamics After the Norwood Operation” 2004, The Annals of Thoracic Surgery 78:1090-1093.
[cited by applicant]
Oury et al. “The Ross Procedure: Currently Registry Results” 1998, The Annals of Thoracic Surgery 66:S162-S165.
[cited by applicant]
Parker et al. “Updated National Birth Prevalence Estimates for Selected Birth Defects in the United States, 2004-2006” 2010, Birth Defects Research (Part A): Clinical and Molecular Tetratology 88:1008-1016.
[cited by applicant]
International Search Report and Written Opinion for application No. PCT/US2025/031779 dated Aug. 19, 2025.
[cited by applicant]