IP Library › Granted Patent US 12,310,871
Granted Patent B2
US 12,310,871 · App. 18/379,457 · Granted May 27, 2025

Implantable medical device constraint and deployment apparatus

Inventors: Criag W. Irwin (Parks, AZ); James D. Silverman (Flagstaff, AZ)
Assignee: W. L. Gore & Associates, Inc.
A61F2/966A61B17/12022A61F2/95A61F2/9525A61F2/962A61B2017/12054A61F2/9517A61F2/9522A61F2250/0067Y10T29/49872
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Quick Facts
Patent No.
US 12,310,871
App. No.
18/379,457
Granted
May 27, 2025
Kind
B2
Abstract

An implantable medical device deployment system is disclosed that employs both a sheath element and a constraint member to protect implantable medical devices during delivery in a body while providing simple, accurate, and reliable device deployment. The delivery system is configured so that loading and deployment forces are not directly related to device diameter, length, or design, thus allowing a more universal delivery system across various delivered device configurations and product lines. The deployment system can provide numerous benefits, include better protection for drug-coated implantable devices.

Claims (19)

1. A medical device deployment system comprising:

a first sheath and a second sheath, wherein each of said first and second sheaths is non-proportionally actuated by the application of tension to tensile members connected to each of the first and second sheaths, wherein on deployment by the application of a single input force, said input force is variably distributed between said tensile members.

2. The deployment system of claim 1 , wherein the medical device is self-expanding.

3. The deployment system of claim 1 , wherein the outer portion of the first sheath coaxially surrounds the inner portion of the first sheath.

4. The deployment system of claim 1 , wherein the two separate tensile forces cause withdrawal of the first sheath and second sheath at two different rates.

5. The deployment system of claim 4 , wherein the two different rates comprise varying differential rates.

6. The deployment system of claim 1 , wherein the medical device includes a bio-active coating, and wherein the first sheath acts to protect the bio-active coating during delivery of the medical device.

7. The deployment system of claim 6 , wherein the bio-active coating comprises a drug coating.

8. The deployment system of claim 1 , wherein the first sheath includes a helical pleat.

9. The deployment system of claim 1 , wherein the medical device has limited axial strength and is protected from damage during delivery by augmented axial strength provided by the first sheath.

10. The deployment system of claim 1 , wherein the interaction of the first sheath and the second sheath serve to decouple deployment force from a length of the implantable device.

11. The deployment system of claim 1 , wherein the second sheath comprises a filament that unravels upon the application of the second tensile force to the filament.

12. The deployment system of claim 1 , wherein the first sheath comprises a filament that unravels upon the application of the first tensile force to the filament.

13. A medical device deployment system comprising:

a first sheath and a second sheath, wherein each of said first and second sheaths is non-proportionally actuated by the application of tension to tensile members connected to each of the first and second sheaths, wherein on deployment by the application of a single input force, said input force is variably distributed between said tensile members.

14. The deployment system of claim 13 , wherein input force is variably distributed between tensile members through use of a pulley.

15. The deployment system of claim 13 , wherein input force is variably distributed between tensile members through use of a differential element.

16. The deployment system of claim 13 , wherein input force is variably distributed between tensile members through use of a clutch mechanism.

17. The deployment system of claim 13 , further comprising two or more pulleys that engage through a rotating planetary rolling element, wherein each of said pulleys is configured to accumulate a deployment line, wherein said deployment lines actuate deployment of a medical device.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 27, 2024
From: IRWIN, CRAIG W.; SILVERMAN, JAMES D.
To: W. L. GORE & ASSOCIATES, INC.
Reel/Frame 068719/0981 →
Continuity (4)
Division 17195335 · Mar 8, 2021
Continuation 14639699 · Mar 5, 2015
Provisional Application 61949100 · Mar 6, 2014
Related Publication 20240033115A1 · Feb 1, 2024
References Cited (295)
US 4553545A · Maass et al. · 1985 [cited by applicant]
US 4606347A · Fogarty et al. · 1986 [cited by applicant]
US 4732152A · Wallsten et al. · 1988 [cited by applicant]
US 4848343A · Wallsten et al. · 1989 [cited by applicant]
US 4921479A · Grayzel · 1990 [cited by applicant]
US 5064435A · Porter · 1991 [cited by applicant]
US 5389100A · Bacich et al. · 1995 [cited by applicant]
US 5425765A · Tiefenbrun et al. · 1995 [cited by applicant]
US 5445646A · Euteneuer et al. · 1995 [cited by applicant]
US 5534007A · St et al. · 1996 [cited by applicant]
US 5571135A · Fraser et al. · 1996 [cited by applicant]
US 5647857A · Anderson et al. · 1997 [cited by applicant]
US 5662703A · Yurek et al. · 1997 [cited by applicant]
US 5755769A · Richard et al. · 1998 [cited by applicant]
US 5824041A · Lenker et al. · 1998 [cited by applicant]
US 5989280A · Euteneuer et al. · 1999 [cited by applicant]
US 6004328A · Solar · 1999 [cited by applicant]
US 6019787A · Richard et al. · 2000 [cited by applicant]
US 6039721A · Johnson et al. · 2000 [cited by applicant]
US 6042605A · Martin et al. · 2000 [cited by applicant]
US 6059813A · Vrba et al. · 2000 [cited by applicant]
US 6113608A · Monroe et al. · 2000 [cited by applicant]
US 6203550B1 · Olson · 2001 [cited by applicant]
US 6224627B1 · Armstrong et al. · 2001 [cited by applicant]
US 6238410B1 · Vrba et al. · 2001 [cited by applicant]
US 6254628B1 · Wallace et al. · 2001 [cited by applicant]
US 6315792B1 · Armstrong et al. · 2001 [cited by applicant]
US 6334867B1 · Anson · 2002 [cited by applicant]
US 6350278B1 · Lenker et al. · 2002 [cited by applicant]
US 6352553B1 · Van et al. · 2002 [cited by applicant]
US 6352561B1 · Leopold et al. · 2002 [cited by applicant]
US 6364904B1 · Smith · 2002 [cited by applicant]
US 6383171B1 · Gifford et al. · 2002 [cited by applicant]
US 6398758B1 · Jacobsen et al. · 2002 [cited by applicant]
US 6524335B1 · Hartley et al. · 2003 [cited by applicant]
US 6533806B1 · Sullivan et al. · 2003 [cited by applicant]
US 6544278B1 · Vrba et al. · 2003 [cited by applicant]
US 6607552B1 · Hanson · 2003 [cited by applicant]
US 6645242B1 · Quinn · 2003 [cited by applicant]
US 6676693B1 · Belding et al. · 2004 [cited by applicant]
US 6733521B2 · Chobotov et al. · 2004 [cited by applicant]
US 6790225B1 · Shannon et al. · 2004 [cited by applicant]
US 6899728B1 · Phillips et al. · 2005 [cited by applicant]
US 6911039B2 · Shiu et al. · 2005 [cited by applicant]
US 6942682B2 · Vrba et al. · 2005 [cited by applicant]
US 6949112B1 · Sridharan et al. · 2005 [cited by applicant]
US 6974471B2 · Van et al. · 2005 [cited by applicant]
US 7081132B2 · Cook et al. · 2006 [cited by applicant]
US 7147661B2 · Chobotov et al. · 2006 [cited by applicant]
US 7198636B2 · Cully et al. · 2007 [cited by applicant]
US 7201770B2 · Johnson et al. · 2007 [cited by applicant]
US 7285130B2 · Austin · 2007 [cited by applicant]
US 7425219B2 · Quadri · 2008 [cited by applicant]
US 7632296B2 · Malewicz · 2009 [cited by applicant]
US 7645298B2 · Hartley et al. · 2010 [cited by applicant]
US 7655034B2 · Mitchell et al. · 2010 [cited by applicant]
US 7753945B2 · Bruun et al. · 2010 [cited by applicant]
US 7794488B2 · Vrba et al. · 2010 [cited by applicant]
US 7828837B2 · Khoury · 2010 [cited by applicant]
US 7837724B2 · Keeble et al. · 2010 [cited by applicant]
US 7938851B2 · Olson et al. · 2011 [cited by applicant]
US 7955370B2 · Gunderson · 2011 [cited by applicant]
US 7976575B2 · Hartley · 2011 [cited by applicant]
US 8016872B2 · Parker · 2011 [cited by applicant]
US 8147538B2 · Brown et al. · 2012 [cited by applicant]
US 8167926B2 · Hartley et al. · 2012 [cited by applicant]
US 8167927B2 · Chobotov · 2012 [cited by applicant]
US 8231665B2 · Kim et al. · 2012 [cited by applicant]
US 8241346B2 · Chobotov · 2012 [cited by applicant]
US 8257431B2 · Henderson et al. · 2012 [cited by applicant]
US 8262671B2 · Osypka · 2012 [cited by applicant]
US 8317854B1 · Ryan et al. · 2012 [cited by applicant]
US 8328861B2 · Martin et al. · 2012 [cited by applicant]
US 8361135B2 · Dittman · 2013 [cited by applicant]
US 8435282B2 · Silverman · 2013 [cited by applicant]
US 8480725B2 · Rasmussen et al. · 2013 [cited by applicant]
US 8540760B2 · Paul et al. · 2013 [cited by applicant]
US 8641752B1 · Holm et al. · 2014 [cited by applicant]
US 8764816B2 · Koss et al. · 2014 [cited by applicant]
US 8790387B2 · Nguyen et al. · 2014 [cited by applicant]
US 8801774B2 · Silverman · 2014 [cited by applicant]
US 8845712B2 · Irwin et al. · 2014 [cited by applicant]
US 8936634B2 · Irwin et al. · 2015 [cited by applicant]
US 8968384B2 · Pearson et al. · 2015 [cited by applicant]
US 9060895B2 · Hartley et al. · 2015 [cited by applicant]
US 9114037B2 · Silverman · 2015 [cited by applicant]
US 9132025B2 · Aristizabal et al. · 2015 [cited by applicant]
US 9186487B2 · Dubrul et al. · 2015 [cited by applicant]
US 9254204B2 · Roeder et al. · 2016 [cited by applicant]
US 9308349B2 · Rezac et al. · 2016 [cited by applicant]
US 9498361B2 · Roeder et al. · 2016 [cited by applicant]
US 9526641B2 · Irwin et al. · 2016 [cited by applicant]
US 9539360B2 · Cully et al. · 2017 [cited by applicant]
US 9585743B2 · Cartledge et al. · 2017 [cited by applicant]
US 9585774B2 · Aristizabal et al. · 2017 [cited by applicant]
US 9622887B2 · Ducke et al. · 2017 [cited by applicant]
US 9668853B2 · Shin · 2017 [cited by applicant]
US 9681968B2 · Goetz et al. · 2017 [cited by applicant]
US 9700701B2 · Benjamin et al. · 2017 [cited by applicant]
US 9763819B1 · Sondreaal · 2017 [cited by applicant]
US 9782284B2 · Hartley et al. · 2017 [cited by applicant]
US 9884170B2 · Campbell et al. · 2018 [cited by applicant]
US 9907641B2 · Johnson · 2018 [cited by applicant]
US 9937070B2 · Skelton et al. · 2018 [cited by applicant]
US 10213329B2 · Cully et al. · 2019 [cited by applicant]
US 10405966B2 · Johnson · 2019 [cited by applicant]
US 10966850B2 · Irwin et al. · 2021 [cited by applicant]
US 11229539B2 · Cully et al. · 2022 [cited by applicant]
US 11540933B2 · Honeyfield et al. · 2023 [cited by applicant]
US 20010044595A1 · Reydel et al. · 2001 [cited by applicant]
US 20010056295A1 · Solem · 2001 [cited by applicant]
US 20020002397A1 · Martin et al. · 2002 [cited by applicant]
US 20020038141A1 · Yang et al. · 2002 [cited by applicant]
US 20020099431A1 · Armstrong et al. · 2002 [cited by applicant]
US 20020138129A1 · Armstrong et al. · 2002 [cited by applicant]
US 20030004561A1 · Bigus et al. · 2003 [cited by applicant]
US 20030105508A1 · Johnson et al. · 2003 [cited by applicant]
US 20030135258A1 · Andreas et al. · 2003 [cited by applicant]
US 20030149399A1 · Langan · 2003 [cited by applicant]
US 20030176910A1 · Vrba et al. · 2003 [cited by applicant]
US 20030199966A1 · Shiu et al. · 2003 [cited by applicant]
US 20030199967A1 · Hartley et al. · 2003 [cited by applicant]
US 20030212410A1 · Stenzel et al. · 2003 [cited by applicant]
US 20030233115A1 · Eversull et al. · 2003 [cited by applicant]
US 20040087886A1 · Gellman · 2004 [cited by applicant]
US 20040092977A1 · Vargas et al. · 2004 [cited by applicant]
US 20040143272A1 · Cully et al. · 2004 [cited by applicant]
US 20040143315A1 · Bruun et al. · 2004 [cited by applicant]
US 20040211433A1 · Albright · 2004 [cited by applicant]
US 20050049675A1 · Wallace · 2005 [cited by applicant]
US 20050059923A1 · Gamboa · 2005 [cited by applicant]
US 20050165352A1 · Henry et al. · 2005 [cited by applicant]
US 20050240254A1 · Austin · 2005 [cited by applicant]
US 20060015135A1 · Vrba et al. · 2006 [cited by applicant]
US 20060015171A1 · Armstrong · 2006 [cited by applicant]
US 20060030923A1 · Gunderson · 2006 [cited by applicant]
US 20060030924A1 · Van et al. · 2006 [cited by applicant]
US 20060041302A1 · Malewicz · 2006 [cited by applicant]
US 20060089627A1 · Burnett et al. · 2006 [cited by applicant]
US 20060122685A1 · Bonsignore et al. · 2006 [cited by applicant]
US 20060173422A1 · Reydel et al. · 2006 [cited by applicant]
US 20060184226A1 · Austin · 2006 [cited by applicant]
US 20060200221A1 · Malewicz · 2006 [cited by applicant]
US 20060206123A1 · Brenneman · 2006 [cited by applicant]
US 20060217796A1 · Dimatteo et al. · 2006 [cited by applicant]
US 20070055358A1 · Krolik et al. · 2007 [cited by applicant]
US 20070060999A1 · Randall et al. · 2007 [cited by applicant]
US 20070093886A1 · Cully et al. · 2007 [cited by applicant]
US 20070142904A1 · Sorenson et al. · 2007 [cited by applicant]
US 20070191925A1 · Dorn · 2007 [cited by applicant]
US 20070208350A1 · Gunderson · 2007 [cited by applicant]
US 20070219612A1 · Andreas et al. · 2007 [cited by applicant]
US 20070244540A1 · Pryor · 2007 [cited by applicant]
US 20080140003A1 · Bei et al. · 2008 [cited by applicant]
US 20080140173A1 · Eskaros et al. · 2008 [cited by applicant]
US 20080167705A1 · Agnew · 2008 [cited by applicant]
US 20080255580A1 · Hoffman et al. · 2008 [cited by applicant]
US 20080281398A1 · Koss et al. · 2008 [cited by applicant]
US 20080312662A1 · Hickingbotham · 2008 [cited by applicant]
US 20090018501A1 · Yribarren et al. · 2009 [cited by applicant]
US 20090099638A1 · Grewe · 2009 [cited by applicant]
US 20090125093A1 · Hansen · 2009 [cited by applicant]
US 20090143713A1 · Van et al. · 2009 [cited by applicant]
US 20090182411A1 · Irwin et al. · 2009 [cited by applicant]
US 20090192584A1 · Gerdts et al. · 2009 [cited by applicant]
US 20090234428A1 · Snow et al. · 2009 [cited by applicant]
US 20090254063A1 · Oepen et al. · 2009 [cited by applicant]
US 20090254170A1 · Hartley et al. · 2009 [cited by applicant]
US 20090270969A1 · Fargahi et al. · 2009 [cited by applicant]
US 20090299449A1 · Styrc · 2009 [cited by applicant]
US 20090326449A1 · Wang et al. · 2009 [cited by applicant]
US 20100004606A1 · Hansen et al. · 2010 [cited by applicant]
US 20100023106A1 · Meyer et al. · 2010 [cited by applicant]
US 20100036360A1 · Herbowy et al. · 2010 [cited by applicant]
US 20100036472A1 · Papp · 2010 [cited by applicant]
US 20100069852A1 · Kelley · 2010 [cited by applicant]
US 20100094398A1 · Malewicz · 2010 [cited by applicant]
US 20100100170A1 · Tan et al. · 2010 [cited by applicant]
US 20100168835A1 · Dorn · 2010 [cited by applicant]
US 20100234933A1 · Punga et al. · 2010 [cited by applicant]
US 20100331955A1 · Vrba et al. · 2010 [cited by applicant]
US 20110009943A1 · Paul et al. · 2011 [cited by applicant]
US 20110015716A1 · Silverman · 2011 [cited by applicant]
US 20110022154A1 · Hamer et al. · 2011 [cited by applicant]
US 20110034987A1 · Kennedy · 2011 [cited by applicant]
US 20110118765A1 · Aguirre · 2011 [cited by applicant]
US 20110118817A1 · Gunderson et al. · 2011 [cited by applicant]
US 20110137401A1 · Dorn et al. · 2011 [cited by applicant]
US 20110137402A1 · Dorn et al. · 2011 [cited by applicant]
US 20110166637A1 · Irwin et al. · 2011 [cited by applicant]
US 20110208292A1 · Von et al. · 2011 [cited by applicant]
US 20120016454A1 · Jantzen et al. · 2012 [cited by applicant]
US 20120059448A1 · Parker et al. · 2012 [cited by applicant]
US 20120078343A1 · Fish · 2012 [cited by applicant]
US 20120120287A1 · Funamoto et al. · 2012 [cited by applicant]
US 20120130472A1 · Shaw · 2012 [cited by applicant]
US 20120130473A1 · Norris et al. · 2012 [cited by applicant]
US 20120130474A1 · Buckley · 2012 [cited by applicant]
US 20120143306A1 · Cully et al. · 2012 [cited by applicant]
US 20120165915A1 · Melsheimer et al. · 2012 [cited by applicant]
US 20120193018A1 · Banas et al. · 2012 [cited by applicant]
US 20120239134A1 · Dierking · 2012 [cited by applicant]
US 20120296406A1 · Minion · 2012 [cited by applicant]
US 20120296408A1 · Jones et al. · 2012 [cited by applicant]
US 20120296412A1 · Paul et al. · 2012 [cited by applicant]
US 20120323315A1 · Bruchman et al. · 2012 [cited by applicant]
US 20130006220A1 · Yribarren et al. · 2013 [cited by applicant]
US 20130035749A1 · Farag · 2013 [cited by applicant]
US 20130046371A1 · Greenberg et al. · 2013 [cited by applicant]
US 20130150949A1 · Silverman · 2013 [cited by applicant]
US 20130158524A1 · Fargahi · 2013 [cited by applicant]
US 20130172984A1 · Greenberg et al. · 2013 [cited by applicant]
US 20130178888A1 · Bliss et al. · 2013 [cited by applicant]
US 20130204343A1 · Shalev · 2013 [cited by applicant]
US 20130204345A1 · Cully et al. · 2013 [cited by applicant]
US 20130211493A1 · Wubbeling et al. · 2013 [cited by applicant]
US 20130238080A1 · Silverman · 2013 [cited by applicant]
US 20130245742A1 · Norris · 2013 [cited by applicant]
US 20130274851A1 · Kelly · 2013 [cited by applicant]
US 20130296877A1 · Irwin et al. · 2013 [cited by applicant]
US 20130340233A1 · Tollner et al. · 2013 [cited by applicant]
US 20140018610A1 · Von Pechmann et al. · 2014 [cited by applicant]
US 20140081376A1 · Burkart et al. · 2014 [cited by applicant]
US 20140130475A1 · Van et al. · 2014 [cited by applicant]
US 20140135895A1 · Andress et al. · 2014 [cited by applicant]
US 20140277347A1 · Daugherty et al. · 2014 [cited by applicant]
US 20140358156A1 · Argentine · 2014 [cited by applicant]
US 20150134043A1 · Irwin et al. · 2015 [cited by applicant]
US 20150196383A1 · Johnson · 2015 [cited by applicant]
US 20150250630A1 · Irwin et al. · 2015 [cited by applicant]
US 20160045349A1 · Kilgrow et al. · 2016 [cited by applicant]
US 20160206418A1 · Johnsen et al. · 2016 [cited by applicant]
US 20170172724A1 · Cartledge et al. · 2017 [cited by applicant]
US 20170252161A1 · Tran et al. · 2017 [cited by applicant]
US 20170281382A1 · Lostetter et al. · 2017 [cited by applicant]
US 20190247210A1 · Cully et al. · 2019 [cited by applicant]
US 20200022800A1 · Johnson · 2020 [cited by applicant]
US 20200323670A1 · Honeyfield et al. · 2020 [cited by applicant]
US 20210186725A1 · Irwin et al. · 2021 [cited by applicant]
US 20220039940A1 · Johnson · 2022 [cited by applicant]
US 20220125610A1 · Cully et al. · 2022 [cited by applicant]
US 20230104877A1 · Honeyfield et al. · 2023 [cited by applicant]
US 20240099828A1 · Johnson · 2024 [cited by applicant]
US 20240099865A1 · Majolagbe et al. · 2024 [cited by applicant]
AU 2019203691B2 · 2020 [cited by applicant]
CN 102341145A · 2012 [cited by applicant]
CN 104023677A · 2014 [cited by applicant]
CN 106102596A · 2016 [cited by applicant]
DE 19531659A1 · 1997 [cited by applicant]
EP 1779809A1 · 2007 [cited by applicant]
EP 1441668B1 · 2008 [cited by applicant]
EP 2065015A1 · 2009 [cited by applicant]
EP 1915113B1 · 2010 [cited by applicant]
EP 2175813A1 · 2010 [cited by applicant]
EP 2352464A1 · 2011 [cited by applicant]
EP 1358903B1 · 2011 [cited by applicant]
EP 2491894A1 · 2012 [cited by applicant]
EP 2609895A2 · 2013 [cited by applicant]
EP 1474074B1 · 2014 [cited by applicant]
EP 2749251B1 · 2016 [cited by applicant]
EP 2956198B1 · 2017 [cited by applicant]
JP 2000279532A · 2000 [cited by applicant]
JP 2002518086A · 2002 [cited by applicant]
JP 2002537026A · 2002 [cited by applicant]
JP 2006006648A · 2006 [cited by applicant]
JP 2007534441A · 2007 [cited by applicant]
JP 2010526583A · 2010 [cited by applicant]
JP 2011509744A · 2011 [cited by applicant]
JP 2013048778A · 2013 [cited by applicant]
JP 2017511725A · 2017 [cited by applicant]
JP 2017094144A · 2017 [cited by applicant]
WO 9808456A1 · 1998 [cited by applicant]
WO 9826731A2 · 1998 [cited by applicant]
WO 9965420A1 · 1999 [cited by applicant]
WO 0048645A2 · 2000 [cited by applicant]
WO 0101886A1 · 2001 [cited by applicant]
WO 0122903A2 · 2001 [cited by applicant]
WO 0238084A2 · 2002 [cited by applicant]
WO 2005107644A1 · 2005 [cited by applicant]
WO 2008034793A1 · 2008 [cited by applicant]
WO 2008137177A2 · 2008 [cited by applicant]
WO 2009012061A1 · 2009 [cited by applicant]
WO 2009091603A1 · 2009 [cited by applicant]
WO 2009145901A1 · 2009 [cited by applicant]
WO 2010063794A1 · 2010 [cited by applicant]
WO 2010063795A1 · 2010 [cited by applicant]
WO 2010120671A1 · 2010 [cited by applicant]
WO 2011076408A1 · 2011 [cited by applicant]
WO 2012054178A1 · 2012 [cited by applicant]
WO 2013025470A2 · 2013 [cited by applicant]
WO 2014107748A2 · 2014 [cited by applicant]
WO 2019014634A1 · 2019 [cited by applicant]
Annex to Form PCT/ISA/206 Communication Relating to the Results of the Partial International Search, PCT/US2015/019271 mailed May 29, 2015, corresponding to U.S. Appl. No. 14/639,699, 4 pages. [cited by applicant]
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2015/019271, mailed on Sep. 15, 2016, 10 pages. [cited by applicant]
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US15/019271, mailed on Oct. 19, 2015, 16 pages. [cited by applicant]