IP Library › Granted Patent US 12,691,264
Granted Patent B2
US 12,691,264 · App. 16/709,129 · Granted Jul 28, 2026

Medical devices for shunts, occluders, fenestrations and related systems and methods

Inventors: Tom R. McDaniel (Flagstaff, AZ); Edward E. Shaw (Flagstaff, AZ)
Assignee: W. L. Gore & Associates, Inc.
A61M27/002A61M2202/0478A61M2205/0238A61M2205/0266A61M2205/04A61M2207/00A61M2210/125
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,691,264
App. No.
16/709,129
Filed
Dec 10, 2019
Granted
Jul 28, 2026
Kind
B2
Examiner
WENG, KAI H
Art Unit
3781
USPC
604/8
Abstract

An implantable medical device comprising a first frame portion, a second frame portion arranged within the first frame portion and a plurality of diverging elements connecting the first frame portion to the second frame portion.

Claims (19)

1 . An implantable medical device, comprising:

a first frame portion having at least three lobes;

a second frame portion arranged within the first frame portion, wherein the first frame portion and the second frame portion are coplanar with one another within a plane when the device is in an unconstrained configuration, wherein the plane is orthogonal to a longitudinal axis of the implantable medical device, and wherein at least a portion of the first and second frame portions are nonplanar with one another when the device is in a delivery configuration; and

a plurality of diverging elements arranged between the first frame portion and the second frame portion, the plurality of diverging elements diverge from the first frame portion and the second frame portion to form a central frame with at least six diverging points in a deployed configuration.

2 . The device of claim 1 , wherein the first frame portion and the second frame are contiguous with one another.

3 . The device of claim 1 , wherein the central frame defines an opening that is hexagonal in shape when the device is in a deployed configuration.

4 . The device of claim 1 , wherein the first frame portion is located on a first side of a septum, the second frame portion is located on a second side of the septum, and the plurality of diverging elements form a fluid flow path therethrough.

5 . The device of claim 4 , wherein the first and second frame portions are sufficiently flexible to conform to an anatomy of the septum.

6 . The device of claim 1 , wherein the second frame portion includes at least three lobes.

7 . The device of claim 1 , wherein the first frame portion has a first geometry and the second frame portion has a second geometry that is different from the first geometry.

8 . The device of claim 1 , wherein the first frame portion includes six lobes.

9 . The device of claim 1 , wherein each of the lobes of the second frame portion comprises an eyelet configured to aid in delivery of the device.

10 . The device of claim 1 , further comprising a covering material arranged on at least a portion of the device.

11 . The device of claim 10 , wherein the first frame portion includes the covering material and the second frame portion is free of the covering material.

12 . The device of claim 11 , wherein the covering material includes expanded polytetrafluoroethylene (ePTFE).

13 . The device of claim 1 , wherein the first frame portion and the second frame portion are unitary such that the device is formed of a single wire.

14 . The device of claim 1 , further comprising at least one of a coating of heparin to facilitate thromboresistance and patency of the device and a coating of paclitaxel to modulate tissue/cellular response.

15 . The device of claim 1 , wherein the longitudinal axis extends through a center of a lumen defined by the implantable medical device and the plane extends through a portion of the lumen.

16 . The device of claim 1 , wherein the at least three lobes extend perpendicularly to the longitudinal axis in the unconstrained configuration.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 13, 2020
From: MCDANIEL, TOM R.; SHAW, EDWARD E.
To: W. L. GORE & ASSOCIATES, INC.
Reel/Frame 054362/0280 →
Continuity (2)
Provisional Application 62777931 · Dec 11, 2018
Related Publication 20200179663A1 · Jun 11, 2020
References Cited (239)
US 5276276A · Gunn · 1994 [cited by applicant]
US 5334217A · Das · 1994 [cited by applicant]
US 5683411A · Kavteladze et al. · 1997 [cited by applicant]
US 5824055A · Spiridigliozzi et al. · 1998 [cited by applicant]
US 5944738A · Amplatz et al. · 1999 [cited by applicant]
US 6042602A · Wells · 2000 [cited by applicant]
US 6042605A · Martin et al. · 2000 [cited by applicant]
US 6077291A · Das · 2000 [cited by applicant]
US 6080182A · Shaw et al. · 2000 [cited by applicant]
US 6461665B1 · Scholander · 2002 [cited by applicant]
US 6616675B1 · Evard et al. · 2003 [cited by applicant]
US 6911037B2 · Gainor et al. · 2005 [cited by applicant]
US 6926670B2 · Rich et al. · 2005 [cited by applicant]
US 7001409B2 · Amplatz · 2006 [cited by applicant]
US 7049380B1 · Chang et al. · 2006 [cited by applicant]
US 7128073B1 · Van et al. · 2006 [cited by applicant]
US 7236821B2 · Cates et al. · 2007 [cited by applicant]
US 7462675B2 · Chang et al. · 2008 [cited by applicant]
US 7871659B2 · Cook et al. · 2011 [cited by applicant]
US 7887562B2 · Young et al. · 2011 [cited by applicant]
US 7901702B2 · Schwarz · 2011 [cited by applicant]
US 8021331B2 · Herweck et al. · 2011 [cited by applicant]
US 8043360B2 · Mcnamara et al. · 2011 [cited by applicant]
US 8048440B2 · Chang et al. · 2011 [cited by applicant]
US 8091556B2 · Keren et al. · 2012 [cited by applicant]
US 8480707B2 · Pavcnik et al. · 2013 [cited by applicant]
US 8545525B2 · Surti et al. · 2013 [cited by applicant]
US 8696693B2 · Najafi et al. · 2014 [cited by applicant]
US 8715300B2 · Najafi et al. · 2014 [cited by applicant]
US 8728103B2 · Surti et al. · 2014 [cited by applicant]
US 9241695B2 · Peavey et al. · 2016 [cited by applicant]
US 9314556B2 · Tuseth · 2016 [cited by applicant]
US 9358371B2 · Mcnamara et al. · 2016 [cited by applicant]
US 9399085B2 · Cleek et al. · 2016 [cited by applicant]
US 9456812B2 · Finch et al. · 2016 [cited by applicant]
US 9545300B2 · Cully et al. · 2017 [cited by applicant]
US 9554786B2 · Carley et al. · 2017 [cited by applicant]
US 9629715B2 · Nitzan et al. · 2017 [cited by applicant]
US 9636094B2 · Aurilia et al. · 2017 [cited by applicant]
US 9649481B2 · Sadanand · 2017 [cited by applicant]
US 9681948B2 · Levi et al. · 2017 [cited by applicant]
US 9757107B2 · Mcnamara et al. · 2017 [cited by applicant]
US 9775591B2 · Delgado et al. · 2017 [cited by applicant]
US 9861346B2 · Callaghan · 2018 [cited by applicant]
US 9878162B2 · Mika et al. · 2018 [cited by applicant]
US 9949728B2 · Cahill · 2018 [cited by applicant]
US 10806458B2 · Todd · 2020 [cited by applicant]
US 10925706B2 · Eigler et al. · 2021 [cited by applicant]
US 20020077555A1 · Schwartz · 2002 [cited by applicant]
US 20020077556A1 · Schwartz · 2002 [cited by applicant]
US 20020169475A1 · Gainor et al. · 2002 [cited by applicant]
US 20020173742A1 · Keren et al. · 2002 [cited by applicant]
US 20030055344A1 · Eigler et al. · 2003 [cited by applicant]
US 20030139819A1 · Beer et al. · 2003 [cited by applicant]
US 20040049211A1 · Tremulis et al. · 2004 [cited by applicant]
US 20040063805A1 · Pacetti et al. · 2004 [cited by applicant]
US 20040073242A1 · Chanduszko · 2004 [cited by applicant]
US 20050038351A1 · Starobin et al. · 2005 [cited by applicant]
US 20050049675A1 · Wallace · 2005 [cited by applicant]
US 20050148925A1 · Rottenberg et al. · 2005 [cited by applicant]
US 20050283231A1 · Haug et al. · 2005 [cited by applicant]
US 20060008500A1 · Chavan et al. · 2006 [cited by applicant]
US 20060009800A1 · Christianson et al. · 2006 [cited by applicant]
US 20060079736A1 · Chin et al. · 2006 [cited by applicant]
US 20060100687A1 · Fahey et al. · 2006 [cited by applicant]
US 20060116590A1 · Fayram et al. · 2006 [cited by applicant]
US 20060198866A1 · Chang et al. · 2006 [cited by applicant]
US 20060271116A1 · Stahmann et al. · 2006 [cited by applicant]
US 20070032734A1 · Najafi et al. · 2007 [cited by applicant]
US 20070118039A1 · Bodecker et al. · 2007 [cited by applicant]
US 20070118213A1 · Loulmet · 2007 [cited by applicant]
US 20070244518A1 · Callaghan · 2007 [cited by examiner]
US 20070282430A1 · Thommen et al. · 2007 [cited by applicant]
US 20080221551A1 · Goodson et al. · 2008 [cited by applicant]
US 20080249562A1 · Cahill · 2008 [cited by applicant]
US 20080262518A1 · Freudenthal · 2008 [cited by applicant]
US 20080269551A1 · Annest et al. · 2008 [cited by applicant]
US 20090024042A1 · Nunez et al. · 2009 [cited by applicant]
US 20090030331A1 · Hochareon et al. · 2009 [cited by applicant]
US 20090099640A1 · Weng · 2009 [cited by applicant]
US 20090221923A1 · Uemura et al. · 2009 [cited by applicant]
US 20090240427A1 · Siereveld et al. · 2009 [cited by applicant]
US 20090319037A1 · Rowe et al. · 2009 [cited by applicant]
US 20100049313A1 · Alon et al. · 2010 [cited by applicant]
US 20100069778A1 · Bornzin et al. · 2010 [cited by applicant]
US 20100094401A1 · Kolbel et al. · 2010 [cited by applicant]
US 20110071623A1 · Finch et al. · 2011 [cited by applicant]
US 20110071624A1 · Finch et al. · 2011 [cited by applicant]
US 20110098767A1 · Sugimachi et al. · 2011 [cited by applicant]
US 20110153010A1 · Hanna · 2011 [cited by applicant]
US 20110184439A1 · Anderson et al. · 2011 [cited by applicant]
US 20110257723A1 · Mcnamara · 2011 [cited by applicant]
US 20110295183A1 · Finch et al. · 2011 [cited by applicant]
US 20110295366A1 · Finch et al. · 2011 [cited by applicant]
US 20110303229A1 · Najafi et al. · 2011 [cited by applicant]
US 20120136385A1 · Cully · 2012 [cited by applicant]
US 20120265296A1 · Mcnamara et al. · 2012 [cited by applicant]
US 20130144379A1 · Najafi et al. · 2013 [cited by applicant]
US 20130165967A1 · Amin et al. · 2013 [cited by applicant]
US 20130178784A1 · Mcnamara et al. · 2013 [cited by applicant]
US 20130281988A1 · Magnin et al. · 2013 [cited by applicant]
US 20140012368A1 · Sugimoto et al. · 2014 [cited by applicant]
US 20140018911A1 · Zhou et al. · 2014 [cited by applicant]
US 20140107437A1 · Pinsky · 2014 [cited by applicant]
US 20140128795A1 · Keren et al. · 2014 [cited by applicant]
US 20140142617A1 · Arsen et al. · 2014 [cited by applicant]
US 20140200662A1 · Eftel et al. · 2014 [cited by applicant]
US 20140207153A1 · Najafi et al. · 2014 [cited by applicant]
US 20140214149A1 · Kuraguntla et al. · 2014 [cited by applicant]
US 20140222040A1 · Park et al. · 2014 [cited by applicant]
US 20140228683A1 · Aoki et al. · 2014 [cited by applicant]
US 20140343670A1 · Bakis et al. · 2014 [cited by applicant]
US 20140371843A1 · Wilson et al. · 2014 [cited by applicant]
US 20150039084A1 · Levi et al. · 2015 [cited by applicant]
US 20150142049A1 · Delgado et al. · 2015 [cited by applicant]
US 20150313596A1 · Todd · 2015 [cited by applicant]
US 20150313599A1 · Johnson et al. · 2015 [cited by applicant]
US 20160045165A1 · Braido et al. · 2016 [cited by applicant]
US 20160058452A1 · Brenneman et al. · 2016 [cited by applicant]
US 20160158000A1 · Granada et al. · 2016 [cited by applicant]
US 20160263299A1 · Xu et al. · 2016 [cited by applicant]
US 20160331566A1 · Kheradvar et al. · 2016 [cited by applicant]
US 20170028194A1 · Bonner et al. · 2017 [cited by applicant]
US 20170042705A1 · Cook et al. · 2017 [cited by applicant]
US 20170105711A1 · Masters · 2017 [cited by applicant]
US 20170106176A1 · Taft et al. · 2017 [cited by applicant]
US 20170135817A1 · Tylis et al. · 2017 [cited by applicant]
US 20170172766A1 · Vong et al. · 2017 [cited by applicant]
US 20170196673A1 · Cully et al. · 2017 [cited by applicant]
US 20170224323A1 · Rowe et al. · 2017 [cited by applicant]
US 20170281339A1 · Levi et al. · 2017 [cited by applicant]
US 20170319823A1 · Yacoby et al. · 2017 [cited by applicant]
US 20170358942A1 · Pugh et al. · 2017 [cited by applicant]
US 20180000580A1 · Wallace et al. · 2018 [cited by applicant]
US 20180008830A1 · Kaiser · 2018 [cited by applicant]
US 20180055629A1 · Oba et al. · 2018 [cited by applicant]
US 20180098772A1 · Goldshtein et al. · 2018 [cited by applicant]
US 20180126179A1 · Haasl et al. · 2018 [cited by applicant]
US 20180160917A1 · Liu et al. · 2018 [cited by applicant]
US 20180256865A1 · Finch et al. · 2018 [cited by applicant]
US 20180280667A1 · Keren · 2018 [cited by applicant]
US 20190130069A1 · Li et al. · 2019 [cited by applicant]
US 20190231510A1 · Rafiee et al. · 2019 [cited by applicant]
US 20190282178A1 · Volosin et al. · 2019 [cited by applicant]
US 20190374343A1 · Lashinski et al. · 2019 [cited by applicant]
US 20200038567A1 · Siess et al. · 2020 [cited by applicant]
US 20200069426A1 · Conklin et al. · 2020 [cited by applicant]
US 20200085378A1 · Burnett et al. · 2020 [cited by applicant]
US 20200196876A1 · Minor et al. · 2020 [cited by applicant]
US 20200196943A1 · Minor et al. · 2020 [cited by applicant]
US 20200196944A1 · Minor et al. · 2020 [cited by applicant]
US 20200197178A1 · Vecchio · 2020 [cited by applicant]
US 20210259839A1 · Cole et al. · 2021 [cited by applicant]
US 20210290214A1 · Cole et al. · 2021 [cited by applicant]
US 20240130624A1 · Kanjickal et al. · 2024 [cited by applicant]
US 20250186208A1 · Chang et al. · 2025 [cited by applicant]
CA 2995185A1 · 2018 [cited by applicant]
CN 1819855A · 2006 [cited by applicant]
CN 102271727A · 2011 [cited by applicant]
CN 104414692A · 2015 [cited by applicant]
CN 105473107A · 2016 [cited by applicant]
CN 107411848A · 2017 [cited by applicant]
CN 107847751A · 2018 [cited by applicant]
CN 108289737A · 2018 [cited by applicant]
CN 108451569A · 2018 [cited by applicant]
CN 108472142A · 2018 [cited by applicant]
CN 108697505A · 2018 [cited by applicant]
CN 110536657A · 2019 [cited by applicant]
EP 1264572A1 · 2002 [cited by applicant]
EP 2020248A1 · 2009 [cited by applicant]
EP 2637576A1 · 2013 [cited by applicant]
GB 1355373A · 1974 [cited by applicant]
GB 1506432A · 1978 [cited by applicant]
GB 1509023A · 1978 [cited by applicant]
JP 07502918A · 1995 [cited by applicant]
JP 2000505316A · 2000 [cited by applicant]
JP 2001519694A · 2001 [cited by applicant]
JP 2002248105A · 2002 [cited by applicant]
JP 2003061917A · 2003 [cited by applicant]
JP 2003519542A · 2003 [cited by applicant]
JP 2005528181A · 2005 [cited by applicant]
JP 2006528023A · 2006 [cited by applicant]
JP 2007527742A · 2007 [cited by applicant]
JP 2008512139A · 2008 [cited by applicant]
JP 2008512211A · 2008 [cited by applicant]
JP 2008545471A · 2008 [cited by applicant]
JP 2009517137A · 2009 [cited by applicant]
JP 2010505481A · 2010 [cited by applicant]
JP 2012500665A · 2012 [cited by applicant]
JP 2013517890A · 2013 [cited by applicant]
JP 2014503246A · 2014 [cited by applicant]
JP 2014151049A · 2014 [cited by applicant]
JP 2016511656A · 2016 [cited by applicant]
JP 2016518948A · 2016 [cited by applicant]
JP 2016538094A · 2016 [cited by applicant]
JP 2017513545A · 2017 [cited by applicant]
JP 2017515631A · 2017 [cited by applicant]
JP 2017536857A · 2017 [cited by applicant]
JP 2021531097A · 2021 [cited by applicant]
WO 9313712A1 · 1993 [cited by applicant]
WO 9727898A1 · 1997 [cited by applicant]
WO 9842276A1 · 1998 [cited by applicant]
WO 0151123A1 · 2001 [cited by applicant]
WO 2003103476A2 · 2003 [cited by applicant]
WO 2004091411A2 · 2004 [cited by applicant]
WO 2005074367A2 · 2005 [cited by applicant]
WO 2006054343A1 · 2006 [cited by applicant]
WO 2007062299A2 · 2007 [cited by applicant]
WO 2008040555A2 · 2008 [cited by applicant]
WO 2009137755A2 · 2009 [cited by applicant]
WO 2010022138A2 · 2010 [cited by applicant]
WO 2011093941A2 · 2011 [cited by applicant]
WO 2012091809A1 · 2012 [cited by applicant]
WO 2014018977A1 · 2014 [cited by applicant]
WO 2014150106A1 · 2014 [cited by applicant]
WO 2015109027A2 · 2015 [cited by applicant]
WO 2015168501A2 · 2015 [cited by applicant]
WO 2017118738A1 · 2017 [cited by applicant]
WO 2018017900A1 · 2018 [cited by applicant]
WO 2020018697A1 · 2020 [cited by applicant]
Eigler et al., “Cardiac Unloading with an Implantable Interatrial Shunt in Heart Failure: Serial Observations in an Ovine Model of Ischemic Cardiomyopathy”, Structural Heart, vol. 1, No. (1-2), 2017, 'pp. 40-48. [cited by applicant]
Feldman et al., “Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure Rationale and Design of the Randomized Trial to Reduce Elevated Left Atrial Pressure in Heart Failure (Reduce LAP-HF I)”, Circul… [cited by applicant]
Gregg et al., “Interatrial Shunting for Heart Failure The V-Wave Shunt”, Presentation at the Transcatheter Cardiovascular Therapeutics (TCT) Congress in Denver, Colorado, 2017, 18 pages. [cited by applicant]
Søndergaard et al., “Transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel interatrial implant to lower left atrial pressure”, European Journal of Heart Failure, vol. … [cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2019/068277, mailed on Mar. 25, 2020, 13 pages. [cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2019/068280, mailed on Mar. 25, 2020, 12 pages. [cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2019/068282, mailed on Mar. 25, 2020, 15 pages. [cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2019/068275, mailed on Jul. 1, 2021, 11 pages. [cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2019/068277, mailed on Jul. 1, 2021, 7 pages. [cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2019/068280, mailed on Jul. 1, 2021, 7 pages. [cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2019/068282, mailed on Jul. 1, 2021, 9 pages. [cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2019/068275, mailed on Jun. 25, 2020, 16 pages. [cited by applicant]
Kapur NK et al. Mechanical circulatory support devices for acute right ventricular failure. Circulation. 2017; 136:314-326 (Year: 2017). [cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2019/042248, mailed on Oct. 23, 2019, 18 pages. [cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2019/042252, mailed on Oct. 21, 2019, 18 pages. [cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2021/013411, mailed on May 6, 2021, 11 pages. [cited by applicant]
Wei, X., Liu, X., Rosenzweig, A. What do we know about the cardiac benefits of exercise? Trends in Cardiovascular Medicine; 25(6) : 537-539. Aug. 2015 (Year: 2015). [cited by applicant]
Tanaka Hikaru, et al., “Shinzo No. Byouki to Chiryouaku”, [online], Aug. 23, 2006, Internet URL: https://web.archive.org/web/20060823022639/https://www.mnc.tohou.ac.jp/v-lab/shinkin/medicine/medicine-1-2-1.html. [cited by applicant]
Tanaka et al., “A Pharmaceutical agent for the heart and drugs”, Aug. 23, 2006, pp. 1-5. [cited by applicant]