Granted Patent
B2
US 12,350,406 · App. 18/486,236 · Granted Jul 8, 2025
Sheathed embolization device
Assignee:
THE TEXAS A&M UNIVERSITY SYSTEM
A61L31/06A61B17/12113A61B17/12118A61B17/12181A61F2/07A61L31/146A61L31/148A61L31/18A61L2300/606A61L2400/16A61L2430/36
View Patent ↗
Loading inventors, assignments & file history…
Abstract
An embodiment includes an apparatus comprising: a shape memory polymer (SMP) foam having an outside surface; and a membrane that encapsulates at least 50% of the outside surface of the SMP foam; wherein (a) the SMP foam includes a thermoset SMP, and (b) the membrane includes a thermoplastic polymer. Other embodiments are addressed herein.
Claims (23)
1. An apparatus comprising:
a thermoset shape memory polymer (SMP) foam comprising: (a) opposing first and second ends, and (b) an outside surface between the first and second ends of the SMP foam;
a thermoplastic membrane;
a shape memory (SM) metal frame coupled to the SMP foam and the membrane, the SM metal frame including first and second struts; and
a deployment conduit;
wherein: (a) the SMP foam, the membrane, and the SM metal frame are included in the deployment conduit, and (b) the membrane is not an adhesive that adheres to the SMP foam;
wherein the membrane includes at least one of polyester, polytetrafluoroethylene (PTFE), extruded PTFE (ePTFE), ultra-high-molecular-weight polyethylene (UHMWPE), polyurethane, poly (p-xylylene), nylon, poly (carbonate), fluorinated ethylene propylene (FEP), polyamide, polyether, polyethylene, polyethylene terephthalate (PET), polypropylene, or combinations thereof;
wherein an axis traverses: (a) first and second portions of the SM metal frame, (b) first and second portions of the membrane, and (c) the SMP foam;
wherein the membrane encircles the first strut;
wherein the membrane directly contacts both the first strut and the SMP foam.
2. The apparatus of claim 1 , wherein the SMP foam is a reticulated polyurethane foam.
3. The apparatus of claim 2 , wherein the membrane is not a foam.
4. The apparatus of claim 1 wherein the SMP foam includes a polymer that comprises polymerized monomers, the monomers including hydroxypropyl ethylenediamine (HPED), triethanolamine (TEA), and hexamethylene diisocyanate (HDI).
5. The apparatus of claim 1 , wherein the membrane directly contacts the second strut.
6. The apparatus of claim 1 , wherein the membrane is fixedly adhered to the SM metal frame.
7. The apparatus of claim 1 , wherein the SM metal frame is self-expanding.
8. The apparatus of claim 1 , wherein the first and second struts are included in a mesh.
9. The apparatus of claim 1 , wherein the SMP foam comprises a hollow center.
10. The apparatus of claim 9 , wherein the axis traverses the hollow center of the SMP foam.
11. The apparatus of claim 1 comprising an additional membrane that encases the SMP foam.
12. The apparatus of claim 11 wherein the additional membrane is configured to expand in response to expansion of the SMP foam.
13. The apparatus of claim 11 , wherein the additional membrane comprises perforations, each of the perforations coupling opposing surfaces of the membrane to one another.
14. The apparatus of claim 13 comprising at least 20 perforations, wherein each of the at least 20 perforations includes a diameter greater than 150 microns.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 26, 2026
From: MAITLAND, DUNCAN J.; ORENDAIN, ADAM M.
To: THE TEXAS A&M UNIVERSITY SYSTEM
Reel/Frame 074753/0844 →
Continuity (3)
Continuation
16652588
Provisional Application
62570333
· Oct 10, 2017
References Cited (89)
US 6152144A
· Lesh et al.
· 2000
[cited by applicant]
US 8876895B2
· Tuval et al.
· 2014
[cited by applicant]
US 8993831B2
· Sharma et al.
· 2015
[cited by applicant]
US 9023074B2
· Teobald et al.
· 2015
[cited by applicant]
US 20100179647A1
· Carpenter
· 2010
[cited by examiner]
CN 103110444A
· 2013
[cited by applicant]
CN 104053409A
· 2014
[cited by applicant]
CN 105246540A
· 2016
[cited by applicant]
CN 105907059A
· 2016
[cited by applicant]
CN 106999271A
· 2017
[cited by applicant]
JP 2016518155A
· 2016
[cited by applicant]
WO 2017040918A1
· 2017
[cited by applicant]
Chinese Patent Office, Office Action dated Aug. 15, 2023 in Chinese Patent Application No. 201880079784.8 (15 pages).
[cited by applicant]
International Search Report and Written Opinion, issued in International Application No. PCT/US2018/055164, dated Jan. 24, 2019, nine pages.
[cited by applicant]
Orendain, “Design, Fabrication, and Testing of a Sheathed Embolization Device,” Master of Science, Texas A&M University, Dec. 2017, 100 pages.
[cited by applicant]
Hasan et al., “Modification of Shape Memory Polymer Foams Using Tungsten, Aluminum Oxide, and Silicon Dioxide Nanoparticles,” RSC Adv. 2016; 6(2): 918-927.
[cited by applicant]
Horn et al., “Comparison of Shape Memory Polymer Foam Versus Bare Metal Coil Treatments in an in vivo Porcine Sidewall Aneurysm Model,” published online Jun. 3, 2016, Wiley Online Library, pp. 1892-1905.
[cited by applicant]
Hasan et al., “Porous Shape Memory Polymers: Design and Application,” published online Jan. 10, 2016, Journal of Polymer Science, Part B: Polymer Physics 2016, 54, 1300-1318.
[cited by applicant]
Landsman et al., “Design and Verification of a Shape Memory Polymer Peripheral Occlusion Device,” Journal of the Mechanical Behavior of Biomedical Materials 63 (2016), 195-206.
[cited by applicant]
Rodriguez et al., “In Vivo Response to an Implanted Shape Memory Polyurethane Foam in a Porcine Aneurysm Model,” Journal of Biomedical Materials Research Part A, May 2014, vol. 102A, Issue 5, pp. 1231-1242.
[cited by applicant]
Romero et al., “Cardiac Imaging for Assessment of Left Arterial Appendage Stasis and Thrombosis,” Nature Reviews, Cardiology, vol. 11, Aug. 2014, pp. 470-480.
[cited by applicant]
Holmes et al., “Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation: a Randomised Non-Inferiority Trial,” The Lancet, vol. 374, Aug. 15…
[cited by applicant]
Lloyd-Jones et al., “Lifetime Risk for Development of Atrial Fibrillation,” The Framingham Heart Study, 2004, pp. 1042-1046.
[cited by applicant]
Romero et al., “Left Atrial Appendage Closure Devices,” Clinical Medicine Insights: Cardiology, 2014: 8, pp. 45-52.
[cited by applicant]
Akinapelli et al., “Left Atrial Appendage Closure—the Watchman Device,” Current Cardiology Reviews, 2015, vol. 11, No. 4, pp. 334-340.
[cited by applicant]
Singh et al., “Left Atrial Appendage Closure,” Current Cardiology Reports, 2010, vol. 12, Issue 5, pp. 413-421.
[cited by applicant]
Lin et al., “Left Atrial Appendage Closure,” Progress in Cardiovascular Diseases, vol. 58, Issue 2, 2015, pp. 195-201.
[cited by applicant]
Bergmann et al., “Left Atrial Appendage Closure for Stroke Prevention in Non-Valvular Atrial Fibrillation: Rationale, Devices in Clinical Development and Insights into Implantation Techniques,” Expert Review, Interventi…
[cited by applicant]
Saw et al., “Percutaneous Left Atrial Appendage Closure: Procedural Techniques and Outcomes,” JACC: Cardiovascular Interventions, vol. 7, Issue 11, Nov. 2014, pp. 1205-1220.
[cited by applicant]
“Particulate Matter in Injections,” Revision Bulletin, Offical Jul. 1, 2012.
[cited by applicant]
“Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems,” Guidance for Industry and FDA Staff, Center for Devices and Radiological Health, dated Apr. 18, 2010.
[cited by applicant]
Kastrup et al., “Early Outcome of Carotid Angioplasty and Stenting with and Without Cerebral Protection Devices,” A Systematic Review of the Literature, Stroke, vol. 34, Issue 3, 2003, pp. 813-819.
[cited by applicant]
Hasan et al., “Effects of Isophorone Diisocyanate on the Thermal and Mechanical Properties of Shape-Memory Polyurethane Foams,” Macromolecular Chemistry and Physics, vol. 215, Issue 24, 2014, pp. 2420-2429.
[cited by applicant]
Rodriguez et al., “Reticulation of Low Density Shape Memory Polymer Foam with an In Vivo Demonstration of Vascular Occlusion,” Journal of the Mechanical Behavior of Biomedical Materials, vol. 40, 2014, pp. 102-114.
[cited by applicant]
Nash et al., “Cold Plasma Reticulation of Shape Memory Embolic Tissue Scaffolds,” Macromolecular Rapid Communications, vol. 37, 2016, pp. 1945-1951.
[cited by applicant]
Singhal et al., “Ultra Density and Highly Crosslinked Biocompatible Shape Memory Polyurethane Foams,” Journal of Polymer Science, Part B, Polymer Physics, vol. 50(10), 724-737.
[cited by applicant]
Small IV et al., “Biomedical Applications of Thermally Activated Shape Memory Polymers,” Journal of Materials Chemistry, vol. 20, 2010, pp. 3356-3366.
[cited by applicant]
Muschenborn et al., “Porous Media Properties of Reticulated Shape Memory Polymer Foams and Mock Embolic Coils for Aneurysm Treatment,” BioMedical Engineering Online 2013, 12:103, p. 1-13.
[cited by applicant]
Nathan et al., “Particulate Release From Nanoparticle-Loaded Shape Memory Polymer Foams,” Journal of Medical Devices, vol. 11, 2017, nine pages.
[cited by applicant]
Möbius-Winkler et al. “Percutaneous Left Atrial Appendage Closure: Technical Aspects and Prevention of Periprocedural Complications with the watchman device,” World Journal of Cardiology, vol. 7, Issue 2, 2015, pp. 65-7…
[cited by applicant]
Swaans et al., “Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation,” Journal of Visualized Experiments, vol. 72, e3818, 2013, nine pages.
[cited by applicant]
Vaidya et al., “An Overview of Embolic Agents,” Seminar in Interventional Radiology, vol. 25, No. 3, 2008, pp. 204-215.
[cited by applicant]
Rodés-Cabau et al, “Transcatheter Closure of the Left Atrial Appendage: Initial Experience with the Amplatzer Cardiac Plug Device,” Catheterization and Cardiovascular Interventions, vol. 76, Issue 2, 2010, pp. 186-192.
[cited by applicant]
Quizhpe et al., “Left Atrial Appendage Closure With the Watchman Device,” Sociedade Brasileria de Hemodinämica e Cardiologia Intervencionista, vol. 22, Issue 1, 2014, pp. 56-63.
[cited by applicant]
Freixa et al., “The Amplatzer Cardiac Plug 2 for Left Atrial Appendage Occlusion: Novel Features and First in-Man Experience,” EuroIntervention, vol. 8, No. 9, 2013, pp. 1094-1098.
[cited by applicant]
Rodriguez et al., “Opacification of Shape Memory Polymer Foam Designed for Treatment of Intracranial Aneurysms,” Annals of Biomedical Engineering, 2012, vol. 40(4), 883-897.
[cited by applicant]
Win et al., “Microemboll Generation, Detection and Characterization During CPB Procedures in Neonates, Infants, and Small Children,” American Society of Artificial Internal Organs Journal, 2008, pp. 486-490.
[cited by applicant]
Siewiorek et al., “The Angioguard Embolic Protection Device,” Expert Rev Med Devices, 2008, vol. 5(3), pp. 287-296.
[cited by applicant]
Order et al., “Comparison of 4 Cerebral Protection Filters for Carotid Angioplasty: An In Vitro Experiment Focusing on Carotid Anatomy,” Journal of Endovascular Therapy, 2004, vol. 11, pp. 211-218.
[cited by applicant]
Truckenmüller et al., “Thermoforming of Film-Based Biomedical Microdevices,” Advanced Materials, 2011, vol. 23, 1311-1329.
[cited by applicant]
Hogan et al., “Transcatheter closure of patent ductus arteriosus in a dog with a peripheral vascular occlusion device,” Journal of Veterinary Cardiology, 2006, vol. 8, pp. 139-143.
[cited by applicant]
Violaris et al., “Endovascular stents: a ‘break through technology’, future challenges,” International Journal of Cardiac Imaging vol. 13, 1997, pp. 3-13.
[cited by applicant]
Wu et al., “Novel Microporous Films and Their Composites,” Journal of Engineered Fibers and Fabrics, vol. 2, Issue 1, 2007, pp. 49-59.
[cited by applicant]
Singhal et al., “Controlling the Actuation Rate of Low-Density Shape-Memory Polymer Foams in Water,” Macromolecular Chemistry and Physics, 2013, vol. 214, 1204-1214.
[cited by applicant]
Chen et al., “Structure and Properties of Polyurethane/Nanosilica Composites,” Journal of Applied Polymer Science, vol. 95, 2005, pp. 1032-1039.
[cited by applicant]
Marois et al., “Biocompatibility of Polyurethanes,” Madame Curie Bioscience Database [Internet], Austin (TX), Landes Bioscience; 2000-2013.
[cited by applicant]
Bartolo et al., “Bio-Materials and Prototyping Applications in Medicine,” Jan. 2008.
[cited by applicant]
Rosset et al., “OsiriX: An Open-Source Software for Navigating in Multidimensional DICOM Images,” Journal of Digital Imaging, vol. 17, No. 3, 2004, pp. 205-216.
[cited by applicant]
Fedorov et al., “3D Slicer as an Image Computing Platform for the Quantitative Imaging Network,” Magn Reson Imaging, 2012, vol. 30(9), pp. 1323-1341.
[cited by applicant]
Cignoni et al., “MeshLab: an Open-Source Mesh Processing Tool,” Eurographics Italian Chapter Conference, 2008.
[cited by applicant]
Kawasaki et al., “Electron Microscopic Evaluations of Clot Morphology During Thrombelastography,” International Anesthesia Research Society. 2004, vol. 99, pp. 1440-1444.
[cited by applicant]
Akin et al., “Left atrial appendage occlusion: A better alternative to anticoagulation?”, World Journal of Cardioliology, 2017, vol. 9(2), pp. 139-146.
[cited by applicant]
Rajwani et al., “Left Atrial Appendage Eccentricity and Irregularity Are Associated With Residual Leaks After Percutaneous Closure,” JACC: Clinical Electrophysiology, 2015, vol. 1, No. 6, pp. 478-485.
[cited by applicant]
Baldez et al., “Employment of polyurethane foam for the adsorption of Methylene Blue in aqueous medium,” Journal of Hazardous Materials, vol. 159, 2008, pp. 580-586.
[cited by applicant]
Chung et al., “Predicting Peri-Device Leakage of Left Atrial Appendage Device Closure Using Novel Three-Dimensional Geometric CT Analysis,” Journal Cardiovascular Ultrasound, 2015, vol. 23(4), pp. 211-218.
[cited by applicant]
Kapur et al., “Left Atrial Appendage Closure Devices For Stroke Prevention,” Arrhythmia & Electrophysiology Review, 2014, vol. 3(1), pp. 25-29.
[cited by applicant]
Mousa et al., “Current update of cerebral embolic protection devices,” Journal of Vascular Surgery, 2012, pp. 1429-1437.
[cited by applicant]
Moody et al., “Brain Microemboli Associated With Cardiopulmonary Bypass: A Histologic and Magnetic Resonance Imaging Study,” The Annals of Thoracic Surgery, vol. 59, Issue 5, 1995, pp. 1304-1307.
[cited by applicant]
“Medical Grade Aliphatic Polyurethan/Urethan/TPU Film,” DelStar Technologies, Inc., 2015.
[cited by applicant]
European Patent Office, Communication Pursuant to Article 94(3) mailed Jul. 26, 2022 in European Patent Application No. 18796221.2 (7 pages).
[cited by applicant]
Japanese Patent Office, Notice of Reason(s) for Refusal mailed Sep. 27, 2022 in Japanese Patent Application No. 2020-520286 (12 pages).
[cited by applicant]
Japanese Patent Office, Office Action dated Apr. 4, 2023 in Japanese Patent Application No. 2020-520286 (9 pages).
[cited by applicant]
Chinese Patent Office, Office Action dated Mar. 4, 2023 in Chinese Patent Application No. 201880079784.8 (20 pages).
[cited by applicant]
European Patent Office, Communication and Written Opinion of the International Searching Authority, mailed May 19, 2020 in European Patent Application No. 18796221.2 (9 pages).
[cited by applicant]
European Patent Office, Communication under Rule 71(3) EPC dated Dec. 6, 2023 in European Patent Application No. 18796221.2 (83 pages).
[cited by applicant]
Chinese Patent Office, Office Action dated Nov. 24, 2023 in Chinese Patent Application No. 201880079784.8 (20 pages).
[cited by applicant]
Chinese Patent Office, Decision on Rejection dated Apr. 27, 2024 in Chinese Patent Application No. 201880079784.8 (17 pages).
[cited by applicant]
Japanese Patent Office, Notice of Reason(s) for Refusal dated Jul. 30, 2024 in Japanese Patent Application No. 2023-126683 (eight pages).
[cited by applicant]
Japanese Patent Office, Notice of Reason(s) for Refusal dated Nov. 19, 2024 in Japanese Patent Application No. 2023-126683 (4 pages).
[cited by applicant]
European Patent Office, Extended European Search Report dated Oct. 10, 2024 in European Patent Application No. 24175506.5 (10 pages).
[cited by applicant]